This matter convened for hearing in San Francisco, California, on January 16, 2002, and January 28 through February 1, 2002, before Edwin Villmoare, Chief Hearing Officer, Special Education Hearing Office, McGeorge School of Law, University of the Pacific.
Petitioner STUDENT was represented by attorney Gail Gresham and, on the first day, attorney Denise Mejlszenkier, both of Protection and Advocacy. Present on Petitioner’s behalf was his mother, MOTHER, and, at various times throughout the hearing, advocate Lisa Navarro of Protection and Advocacy and FATHER, STUDENT’s father.
Respondent San Francisco Unified School District (District) was represented by attorneys Eliza McArthur and Rodney L. Levin. Present at various times for the District were Deborah Phillips, consultant; Jeannie McCullough-Stiles, Registered Nurse (RN) and the District’s coordinator of nursing for special education students; and Katherine Isheim, District’s special education compliance manager.
The parties called the following witnesses to testify: MOTHER; Wai Yu Lam, case manager for the Golden Gate Regional Center (GGRC); Steve Hall, STUDENT’s teacher; Ms. McCullough-Stiles; Dr. Jonathan Strober, Assistant Professor of Pediatrics and Neurology at the University of California, San Francisco (UCSF); and STUDENT’s pediatric neurologist; Dr. Ronald A. Dieckmann, Director of Pediatric Emergency at San Francisco General Hospital and Clinical Professor of Medicine and Pediatrics at UCSF; Dr. Gerald E. Harris, Assistant Clinical Professor of Pediatrics at UCSF and STUDENT’s pediatrician; Dr. Michael Shore, Ph.D., clinical psychologist; Doris Branner, licensed vocational nurse (LVN) providing respite nursing services to STUDENT and his family through the GGRC; Ms. Joyce Eckrem, an attorney for the District; and Deborah Phillips, attorney and RN.
Oral and documentary evidence was received. The parties submitted closing briefs on February 22, 2002, and thereafter the record was closed and the matter submitted for decision.
ISSUE PRESENTED FOR HEARING
Is the District obligated to administer Diastat to STUDENT and to provide STUDENT with the services of qualified health care personnel to ensure him meaningful access to a free appropriate public education and to provide him with a related service under the Individuals with Disabilities Education Act and California special education law?(Footnote 1)
PROCEDURAL MATTERS
1. The District submitted a document entitled “San Francisco Emergency Medical Services” after the close of testimony. The document was admitted into evidence but played no role in the decision.
2. Petitioner filed two motions following the closing of the record, “Petitioner’s Motion to Compel IEP and to Prohibit Harassment by Respondent District” and “Petitioner’s Emergency Motion to Compel Implementation of Current IEP by Respondent and Motion for Protective Orders.” Both motions were denied on the grounds that they raised issues not within the scope of the case submitted for hearing and called for remedies that either are beyond the authority of the Special Education Hearing Office or are the proper subject for another case.
BACKGROUND FACTS
STUDENT is a boy, aged three and a half, who lives with his parents, FATHER and MOTHER, within the boundaries of the San Francisco Unified School District (District). He is eligible for special education on the basis of multiple disabilities. STUDENT was born with a chromosome five inversion and attendant hypertonia, microcephaly, and global delays in cognitive, language, and fine and gross motor development. When STUDENT was approximately one year old, he began to suffer epileptic seizures. The seizures quickly became a matter of great medical concern and changed STUDENT’s young life and that of his parents. Within several months, STUDENT suffered a short seizure, a five-minute seizure, and a fifteen-minute seizure. The fifteen-minute seizure necessitated the first of many emergency room visits for STUDENT. Thereafter, STUDENT suffered two to four seizures a week and was diagnosed with intractable epilepsy. At approximately this time, STUDENT had a gastrointestinal tube (G-tube) placed in his throat to aid in feeding. (STUDENT currently eats puree by mouth. The G-tube is now used primarily to administer water and medicine.)
STUDENT has been seen by several epilepsy and seizure specialists. STUDENT has taken a number of medications to prevent seizures or at least to reduce their severity and frequency. These medications include phenobarbital, clonazepam (Klonopin), divalproex sodium (Depakote), phenytoin (Dilantin), lamotrigine (Lamictal), levetiracetam (Keppra), and zonisamide (Zonegran). All of these drugs were discontinued because they were either ineffective or caused harmful side effects. Because of the failure of seizure-preventing medications, STUDENT was placed on a ketogenic diet. Very high in fats and low in protein and carbohydrates, the diet produces a change in the body’s chemistry called ketosis, which can control or limit seizures. The diet was ineffective for STUDENT and produced increased gagging and vomiting. STUDENT was weaned off the diet by December 2001.
During the year that followed the onset of intractable epilepsy, STUDENT’s parents, on doctors’ orders, called 911 emergency services for seizures lasting over five to seven minutes. The emergency medical technicians would transport STUDENT to the emergency room at a local hospital, with STUDENT’s parents accompanying him. In some instances, the parents drove STUDENT directly to an emergency room. STUDENT was usually treated by the emergency room personnel with rectal Valium. However, in some instances the parents in had difficulty communicating sufficient information on STUDENT's complex condition and medical history amid the hectic activities of emergency rooms. As a result, there were occasions when emergency room personnel administered medications, such as phenobarbital, that severely over-sedated STUDENT and were contraindicated for him by his doctors.
STUDENT’s trips to the emergency room lasted from four to ten hours, depending on a number of factors including STUDENT’s condition, the physicians in charge, and the staffing levels and caseloads of the emergency rooms. STUDENT’s mother, Ms. MOTHER, testified credibly that these trips, between forty and fifty in number within a year, were emotionally draining on the family and often left STUDENT agitated and crying. The unfamiliar people and strange sounds of emergency rooms upset STUDENT as he came out of his seizure and the sleep that often ensues.
In approximately July 2000, STUDENT was prescribed Diastat by his treating pediatric neurologist, Dr. Jonathan Strober, Assistant Clinical Professor of Pediatrics and Neurology at the School of Medicine, University of California, San Francisco (UCSF), with the concurrence of Dr. Gerald E. Harris, Assistant Clinical Professor of Pediatrics at UCSF and STUDENT’s permanent pediatrician, and later with the concurrence of Dr. John Sum, Chief of Pediatric Neurology at the Santa Clara Hospital and STUDENT’s expert on ketogenic diets. The hope was that Diastat would effectively abort STUDENT’s longer seizures (those lasting longer than five minutes) and spare STUDENT and his family the rigors of repeated calls to 911 and trips to emergency rooms.
Diastat is the trade name for a rectal gel form of diazepam (Valium) that is packaged in flexible tubes with available pediatric tips. Diastat was approved by the Food and Drug Administration in 1997 for use outside of hospitals by family members and other care givers of seizure patients. Pharmacologically, Diastat and rectal diazepam (Valium) are the same drug; the terms are often used interchangeably. Diastat has a longer history of use in Europe, especially in England and Scandinavia. One explicit purpose of Diastat is to enable patients with acute seizures to avoid trips to hospital emergency rooms.(Footnote 2) Dr. Strober has made various small changes to the schedule for administering Diastat to STUDENT. For example, he changed the initial five-milligram dose to two 2.5-milligram doses separated by a period of five minutes. The hope was that 2.5 milligrams would on some occasions be sufficient to abort the seizures and spare STUDENT unnecessary medication and grogginess. Dr. Strober has never prescribed the full ten milligrams of Diastat that is generally accepted as the recommended full dose for a pediatric patient of STUDENT’s weight according to the Physician’s Desk Reference (PDR). Petitioner’s Exhibit 23.
In all instances, the administration of Diastat has terminated STUDENT’s seizures and the need for further medical intervention. Following administration of Diastat, STUDENT may be groggy for a while and then return to normal, or may sleep heavily for several hours. Ms. MOTHER’s records indicate that she has administered Diastat to STUDENT approximately thirty-five times since September 1, 2001, and that STUDENT’s respite-care nurses have administered Diastat another four to five times in this period. There are no records on the number of times STUDENT received Diastat between July 2000 and September of 2001, although there were times that STUDENT received Diastat every other day. Ms. MOTHER’s records indicate that she administered Diastat five times in September, eight times in October, thirteen times in November, and twelve times in December 2001. These records indicate that STUDENT never received more than a total of five milligrams for any of these seizures.
Because Diastat is an abortive medication, and all preventive medications and methods had failed to date, Dr. Strober arranged to have a vegus nerve stimulator (VNS) implanted in STUDENT’s chest in September 2001. STUDENT is one of the youngest patients to have received a VNS. The VNS is designed to prevent or reduce the occurrence of seizures by sending small regular pulses of electrical energy to the brain through the vegus nerve, a large inhibitory nerve in the neck. [cite] In instances when a seizure is coming on, the VNS can be specially activated by passing a small magnet over the VNS’s battery. In STUDENT’s case, a “swipe” with the magnet triggers one minute of stimulation. Dr. Strober’s prescription called for STUDENT to receive one swipe if a seizure last longer than five minutes and another swipe if the seizure last as long as ten minutes. Initially, STUDENT’s VNS had little apparent effect. However, the VNS is periodically reprogrammed. In the last part of December 2001, and the first two weeks of January 2002, STUDENT’s longer seizes requiring Diastat were replaced by more frequent seizures of shorter duration. These seizures are allowed to run their course without Diastat. Dr. Strober indicated that, while he hoped that the change in STUDENT’s seizure pattern reflected in part recent adjustments to the VNS, it was far too early to tell if the VNS was effective. STUDENT has a history of shifting seizure patterns and there remains the distinct possibility that he will revert to longer seizures at some point.
STUDENT’s developmental delays and his epilepsy qualified him for a wide variety of services from the Golden Gate Regional Center (GGRC), California Children’s Services (CCS), and the Early Start Program operated by the District. STUDENT received occupational therapy, physical therapy, developmental delay services, speech therapy services, and respite-care nursing to assist his parents. STUDENT attended the Family Development Center, where he received a number of these services. STUDENT remains eligible for respite-care nursing from the GGRC, and for occupational therapy and physical therapy from CCS. The District continues to provide speech therapy. The respite-care nurses provided by GGRC are licensed vocational nurses (LVNs). They administer Diastat to STUDENT as needed, in accordance with Dr. Strober’s orders.
In July 2001, STUDENT turned three and became eligible to attend school in the District under the District’s early education program. To help the District prepare for STUDENT, Dr. Harris wrote a letter indicating that
STUDENT will need continuous care by an LVN or other qualified aide during the day program and also on the bus while going to and from school. The aide will need specific instruction on administering the ketogenic diet and on what to do if he spits up or gags. He or she will need to participate in feeding sessions with the parents before school begins and should read instructional material the parents can provide. A backup aide should be available if the primary care giver cannot be with STUDENT on a particular day. In addition, if STUDENT has a seizure, the care giver should be able to give him his Diastat, an antiseizure medication.
Although the conditions under which STUDENT can attend school in the District are in dispute and the subject of this case, STUDENT did manage to attend school for approximately thirty days during the first semester of the 2001-2002 school year. STUDENT currently attends Steve Hall’s special day class at Los Americas Elementary School.
The assessments prepared by the District in preparation for STUDENT’s first year of school, documents from the GGRC, and the testimony of Mr. Hall and Ms. MOTHER provide a reasonably clear and current picture of STUDENT. STUDENT is a child with significant cognitive and physical limitations. When STUDENT is feeling well, he is alert to his surroundings. STUDENT enjoys going to the park with his parents. He likes being physically close or cuddling with familiar adults such as his parents, his respite nurses, his teacher, and Oscar, one of the paraprofessionals in Mr. Hall’s classroom. STUDENT delights in having people sing to him and likes to touch and explore the texture of various materials. He watches other children with great interest and may try to imitate their behavior, such as clapping. STUDENT can make and hold eye contact, recognize familiar people, and look back and forth between two people engaged in a joint activity.
STUDENT’s communication is primarily receptive with very limited expressive capacities. He understands certain phrases such as “get the toy,” “stand up,” “kissing me,” and “give me your hands.” STUDENT uses few vocalizations, although he may try to imitate singing to get someone to sing to him. He has limited motor control and cannot stand alone. He requires props and supports, such as a box stander or a pony walker, to enable him to sit, stand, and walk.
When STUDENT is not feeling well, as happened often when he was taking certain preventive medications, while on the ketogenic diet, and currently before or after seizures, he may be sleepy or fussy and may cry or show signs of physical agitation. Slow music, a quiet environment with low lighting, and generally reduced stimulation are often necessary to sooth him and enable him to focus on activities. Mr. Hall testified that STUDENT, like other young students with severe disabilities, needs a predictable routine, repetition of tasks and activities, familiar voices and faces, and a familiar environment. Disruption, loud noises, or the appearance of strangers causes STUDENT to suffer anxiety and agitation; however, watching other children can have a calming effect on him.
STUDENT may cough and this may lead to gagging and vomiting. This response was pronounced when he was on the ketogenic diet but can occur at other times, particularly if he has a seizure when being fed. Some of the coughing may be a response to the VNS. When coughing starts, STUDENT’s nurses have found that patting him on the back often interrupts the cycle and prevents vomiting. There is no history of coughing, gagging or vomiting following the administration of Diastat.
STUDENT’s teacher, Mr. Hall, and his mother agree that STUDENT benefits when he attends school and is making limited progress on the goals and objectives in his individualized education program (IEP), which concentrates mainly on functional play skills, cognitive development, and social interaction. However, some concern is expressed in one of the District’s assessments (Respondent’s Exhibit 22) that he may be losing some of his alertness and regressing in some areas. STUDENT’s parents echo this concern.
The conflict between STUDENT’s parents and the District arose over the desire of the parents and his physicians to have Diastat administered at school by a school nurse or other qualified individual. The protocol that Dr. Strober would like to have implemented at the school calls for one swipe of the VNS after five minutes of seizing, then another swipe after another five minutes of seizing combined with the administration of 2.5 milligrams of Diastat, followed, if needed, by another 2.5 milligrams.(Footnote 3) Dr. Strober has instructed STUDENT’s parents and care givers to wait five more minutes, and then administer a third dose of 2.5 milligrams of Diastat, if necessary. If the seizure continues for twenty to twenty-five minutes, Dr. Strober’s orders are to call 911. The District refuses to administer the Diastat and will call 911 as its only response to a prolonged seizure of five minutes or more.
In preparation for STUDENT’s first year of school, Jeannie McCullough-Stiles, RN, coordinator of nursing services for special education students in the District, made a concerted effort in April 2001 to learn about STUDENT’s condition, his use of Diastat, and his ketogenic diet. She contacted Dr. Strober to discuss STUDENT. By letter, dated May 18, 2001, Ms. McCullough-Stiles wrote to Ms. MOTHER reporting on a conversation with Dr. Strober. In her letter, Ms. McCullough-Stiles expressed concern over the interaction of the ketogenic diet with the Diastat and the frequency of use of Diastat, and then stated the following:
This brings me to concerns related to STUDENT’s safety at the school. More specifically, rectal Valium and/or Ativan are not given to students during the school day because of their cumulative effect in the body and the possibility of placing them at risk for respiratory arrest . . ..(Footnote 4)
In a letter dated July 5, 2001, Dr. Strober wrote a letter indicating that the District should administer Diastat, although his letter envisioned the use of 911 services as an alternative to the administration of the Diastat by the District. Dr. Strober testified that he wrote the 911 option into the letter because Ms. McCullough-Stiles had indicated that STUDENT would not be allowed to attend school under any protocol other than 911 services. Dr. Strober indicated that he intended the 911 option as merely a temporary accommodation pending resolution of the dispute.
Thereafter at the IEP meetings held for STUDENT on August 21, 2001, and October 29, 2001, Ms. MOTHER requested that the District provide STUDENT with a one-to-one nurse whose tasks would include administration of Diastat as needed. At the two IEP meetings, the District refused to provide one-to-one nursing services or to administer Diastat to STUDENT. Under the District’s protocol for STUDENT, school staff place STUDENT in a comfortable position, swipe the VNS after five minutes of seizing, and then call 911. Staff will swipe the VNS a second time while awaiting the arrival of the 911 crew. On October 24, Ms. MOTHER filed a request for a due process hearing requesting as a remedy the administration of Diastat by trained District personnel.
STUDENT attended school on October 17 and 18 accompanied by one of his GGRC nurses. The District refused to accept the presence of the nurse and insisted that the Diastat issue be resolved before STUDENT could attend school. Dr. Strober and Dr. Harris then signed an emergency information sheet agreeing to 911 services as the District’s response to STUDENT’s seizures lasting over five minutes. Dr. Harris took the exceptional step of annotating the emergency information sheet with the limitation: “This applies until November 16, after the hearing.” (The hearing in this case was originally set for November 15 and 16, 2001.) STUDENT was not allowed to return to school until after the doctors had given their temporary consent to the District’s 911 protocol for longer seizures.
Throughout the summer and fall of 2001, Ms. McCullough-Stiles had continued to explore ways the District could obtain reliable information on whether or not STUDENT had recently taken Diastat so that it could better understand STUDENT’s condition when he arrived each day at school. In the process, she learned that no one, including the GGRC nurses, had kept records on STUDENT’s use of Diastat prior to September 2001. At about this time, Ms. McCullough-Stiles also began citing a study by Norris, et al (discussed below) in which approximately 9% of the children who received rectal Valium for acute seizures suffered respiratory depression. (Letter to Liz Kim, Petitioner’s Exhibit 6.) In an open letter to all San Francisco school nurses, dated December 21, 2001, Ms. McCullough-Stiles referenced a respiratory depression rate of 1 to 8.8% when Diastat was administered. In this letter, Ms. McCullough-Stiles also charged the “X-cel Pharmaceutical Corporation” with “targeting” pediatric neurologists as a market for Diastat and “encouraging its wide use in American schools as well.”(Footnote 5) Ms. McCullough-Stiles called on the nurses to oppose “the use of Diastat (rectal Valium gel) in school settings where paramedics would quickly arrive at the school site and treat the emergency.” As will become apparent, these percentages of respiratory depression associated with Diastat and the conviction that the use of emergency services is always the proper response by the District to acute epileptic seizures, including STUDENT’s, lies at the heart of the dispute and the District’s case. Ms. MOTHER and Dr. Harris testified that STUDENT has never had any respiratory problems with Diastat or, indeed, any respiratory problems since birth.
STUDENT began to attend school on a regular basis in November 2001. At that time, STUDENT’s serious seizures were occurring in the middle of the night (STUDENT sleeps next to his mother so that she can respond immediately), early in the morning, or in the evening. Mr. Hall testified that although STUDENT experienced several seizures in the ten- to twelve-second range while at school, his serious seizures did not generally occur during the school day. The one exception occurred on December 10, 2001. At about 10:00 a.m. that day, STUDENT began to seize. At 10:05 a.m., Mr. Hall called Ms. MOTHER as he had agreed to do in the case of a serious seizure, and at 10:10 he called 911. Mr. Hall and Ms. Connie Cleghorn, LVN, school nurse, placed STUDENT on his side on a mat on the floor in an open area of the class and loosened his clothing, as is standard practice for treating seizure victims. Ms. Cleghorn made two magnet swipes of the VNS, per doctor’s instructions. At approximately 10:15 a.m., Ms. MOTHER arrived and administered Diastat. Within several minutes STUDENT’s seizures stopped, and several minutes thereafter the 911 crew arrived. Ms. MOTHER asked about STUDENT’s color. The paramedics checked STUDENT’s oxygen intake and found it to be within normal range. The paramedics concluded that STUDENT was not having any respiratory problems. Ms. MOTHER then asked the paramedics to leave STUDENT at school, and, after checking with the physician on duty and explaining a bit of STUDENT’s history, they were permitted to do so. The 911 crew departed at approximately 10:45 a.m.
Ms. MOTHER remained with STUDENT until approximately 11:15 a.m. Convinced that STUDENT was having one of his typical reactions to Diastat (in this case, deep sleep—STUDENT is a heavy sleeper), she too left school. Ms. Cleghorn contacted her supervisor, Evelyn Thomas, RN. Ms. Thomas arrived on the scene at approximately 11:30 a.m., and Ms. Cleghorn returned and then left to check on other students at approximately 11:50 a.m. By this time, approximately one and a half hours had passed since administration of the Diastat.
The two nurses then undertook to assess STUDENT’s condition. They found him pale and his limbs flaccid. His pupils, when he briefly opened his eyes, were dilated. His hands were pink and warm, but his legs and feet were cool. Ms. Thomas attempted to rouse STUDENT by calling to him, pinching his arm, and giving him a sub-sternum rub. STUDENT’s only response was to open his eyes briefly. At 12:15 a.m., STUDENT began to fuss, cry and move about. His color was improved and his eyes were open. The nurses put STUDENT in his stroller. His head hung down and he was drooling a bit. Thereafter, STUDENT slept at brief intervals but was easily roused. Then someone from the District, possibly Ms. McCullough-Stiles, called Ms. MOTHER and ordered her to come and pick STUDENT up because he was believed to be in danger of respiratory depression. Several days later, Ms. MOTHER received a letter from the District prohibiting her from administering Diastat to STUDENT at school.
Ms. MOTHER testified that STUDENT’s reaction to the Diastat on December 10 was not unusual or a source of concern, although he does not always go into a heavy sleep following the administration of Diastat. In Mr. Hall’s view, based on twenty years as a special education teacher working with several epileptic children, STUDENT was sleeping heavily, rather than sedated or in a stupor, when Ms. MOTHER departed.
The arrival of the 911 crew of approximately eight adults accompanied by sirens and flashing lights was not without impact on the other children in Mr. Hall’s class. The class contains twelve severely disabled young children, including four with autism, one with developmental delays, several with speech delays, and several with cerebral palsy. As the 911 crew entered the school, Mr. Hall and his four assistants promptly moved the other students out of the classroom and onto the playground. Mr. Hall testified that STUDENT’s seizure, resulting in his lying on a mat on the floor, did not disturb the other students. In fact, other students from time to time rest or sleep in the same location for various reasons. However, in Mr. Hall’s view, the arrival of the 911 crew, eight strangers in a hurry, was disturbing and “scary” for the students. Even though the other students were quickly moved out of the classroom, Mr. Hall testified that students like his “pick up” on adult stress and his students certainly did on that occasion. Mr. Hall indicated that he would have a definite problem with frequent arrivals of paramedics and firemen to medicate STUDENT and remove him on a gurney. Mr. Hall said that he would be comfortable having STUDENT remain in the classroom following the administration of Diastat, if a nurse were present.
SUMMARY OF MEDICAL TESTIMONY
1. Dr. Jonathan Strober is a board-certified neurologist and psychiatrist with a specialty in pediatrics. He is an Assistant Professor of Pediatrics and Neurology at UCSF. He is the principal physician treating STUDENT’s epilepsy and has had STUDENT as a patient over the last two and a half years. Dr. Strober sees STUDENT and his mother approximately every two weeks. It was apparent during the hearing that Dr. Strober has a strong professional commitment to STUDENT’s best interests and knows STUDENT and his family extremely well.
Dr. Strober indicated that STUDENT has a serious epileptic condition and that it is important to prevent STUDENT’s seizures from reaching status epilepticus, a condition in which a seizure becomes difficult to terminate. Serious cases of untreated status epilepticus can result in neurological damage or death.
Dr. Strober testified in some detail concerning the safety of Diastat in general and for STUDENT in particular. He reported that Diastat had a twenty-year history of safe and effective use in Europe before it was approved for use in the United States. He indicated that, like any drug, it can cause adverse side effects but that respiratory depression, the District’s primary concern, is extremely unlikely. He was not personally aware of any instances in which Diastat had caused respiratory depression among his patients (50% of whom use Diastat at least occasionally) or those of his colleagues in San Francisco or around the country. He discounted the findings in the Norris article as aberrant and unreliable. He pointed out that the article contained no information on the length of the seizures, other medications the patients had taken, or possible co-morbidity in the patients (other illnesses or conditions that might cause or contribute to respiratory depression). He indicated that emergency rooms, where Norris collected his data, produce skewed results because emergency rooms attract a high percentage of seriously ill patients, many of whom have neglected their health. He cited the numerous articles published subsequent to the Norris article that overwhelmingly established an excellent safety record for Diastat and an almost total absence of reported instances of respiratory depression.
With regard to STUDENT, Dr. Strober pointed to a year and a half of successful use of Diastat without any indication of a respiratory problem or other adverse effect. Dr. Strober has successfully reduced the initial dose in a treatment of Diastat from 5 milligrams to 2.5 milligrams and lengthened the time between the onset of the seizure and the initial administration of the 2.5 milligrams to10 minutes to give the VNS a chance to abort the seizure and avoid unnecessary medication.(Footnote 6) He stated that Diastat is working for STUDENT exactly as intended and that there is no sound medical or safety reason to deny STUDENT Diastat in school and force him back to 911 services and emergency rooms. In his view, a school nurse or other trained professional can effectively and safely administer the Diastat at school, just as Ms. MOTHER and the GGRC nurses have done so successfully at home.
Dr. Strober stated that total reliance on 911 services to treat longer seizures would subject STUDENT to possible late arrival from the paramedics, create a risk of STUDENT receiving overdoses or drugs that are less safe for him than Diastat, such as intravenous (IV) Valium and phenobarbital, and expose STUDENT to a wide variety of diseases that patients bring to emergency rooms and hospitals. He indicated that 911 services and emergency rooms are much less safe for STUDENT than Diastat administered by a knowledgeable caretaker and that emergency services should be used only when and if STUDENT has a genuine emergency, such as respiratory depression.
Dr. Strober did not portray STUDENT as a child at no risk. Indeed, given STUDENT’s various disabilities and limitations, he concluded that STUDENT is a child who is “never very safe.” However, in Dr. Strober’s view the proper use of Diastat causes minimal risk for STUDENT at this time.
Dr. Strober addressed the fact that in the past STUDENT had been treated with Diastat more frequently than recommended by the manufacturer in the Physician’s Desk Reference (PDR). (The PDR recommends that Diastat be used to treat no more than five episodes per month and no more than one episode every five days and given in treatment doses of ten milligrams or less for a child of STUDENT’s weight.) Dr. Strober said that, given the limited options available to treat STUDENT and the need to terminate seizures within approximately twenty-five minutes of onset to avoid the risk of status epilepticus, Diastat represented the safest and the most effective solution at this time. Dr. Strober explained that the recommended frequency levels in the PDR reflect that there is a risk of habituation, reduced effectiveness, and possible paradoxical increased risk of seizures. Dr. Strober monitors for these possible effects. Dr. Strober pointed out that the recommended treatment frequencies in the PDR have nothing to do with the risk of respiratory depression; indeed, respiratory depression is not even identified as a possible adverse reaction in the PDR. He indicated that drug tolerance is a matter of individual response and that STUDENT has a long history of excellent tolerance, which is an indication of future tolerance. Dr. Strober did caution that treatment with Diastat more than once per twenty-four hour period would raise a concern of overdosing the central nervous system and that should such dosing become necessary, 911 should be called as a safety backup. Dr. Strober pointed out that, to date, it has never been necessary to call 911 following the administration of Diastat to STUDENT and that STUDENT’s seizures almost always end with the first or second dose of 2.5 milligrams.
Dr. Strober indicated that the District’s proposal to call 911 after five minutes risks having STUDENT wait up to fifteen minutes for the 911 crew to arrive and thus wait a period of twenty minutes before the Diastat or other abortive drug is administered, a time frame that creates a slightly greater risk for STUDENT.
The District’s attorneys posed various questions to Dr. Strober on the issue of emergency medicine. Dr. Strober acknowledged that in a meeting with District personnel he may have indicated that the administration of Diastat could be placed somewhere on an “emergency spectrum,” a term apparently introduced at the meeting by an attorney for the District. However, Dr. Strober explained that he does not regard the administration of Diastat to STUDENT as an emergency procedure but rather as a safe and dependable means of avoiding the possible emergency of status epilepticus. He made it clear that the administration of Diastat does not create a statistical or real risk to STUDENT that is other than “minimal.”
On the issue of STUDENT’s coughing followed occasionally by gagging and more occasionally by vomiting, Dr. Strober said that some of the coughing could be caused by the VNS, but that most of the gagging and vomiting had ended with the elimination of the ketogenic diet. Dr. Strober indicated that there is always some risk that STUDENT could gag on food, particularly if he suffers a seizure while eating. Dr. Strober saw no relationship between gagging and vomiting and administration of Diastat, except that the Diastat would suppress any coughing impulse by relaxing the throat muscles.
Concerning the events on December 10, 2001, Dr. Strober testified that a review of the nurses’ records of the event made by Ms. Cleghorn and Ms. Thomas and the information from Ms. MOTHER concerning the comments of the paramedics indicated to him that STUDENT was safe and in a normal postictal sleep by the time the nurses assessed him. Dr. Strober concluded that since STUDENT’s pulse and respiratory rate were normal and he showed no evidence of a respiratory problem, STUDENT had suffered no adverse reaction to the Diastat.
If the school were to administer Diastat, Dr. Strober recommended a trained one-to-one aide for STUDENT with a school nurse on site, or possibly a one-to-one nurse. He added that supplemental protection could be achieved in case there ever was a respiratory problem by making an “ambu-bag” available to an aide or nurse to assist STUDENT’s breathing until 911 services arrived. (Dr. Strober does not recommend ventilation equipment for the family beyond basic CPR skills because he sees STUDENT’s risk of respiratory problem from Diastat as so small.) He could see absolutely no reason for the District to have intubation equipment available. With regard to the District’s 911-only protocol, he testified that he had signed the form authorizing 911 merely as a temporary and not unreasonable expedient to enable STUDENT to finally attend school, which STUDENT needs to help him overcome his developmental delays and to approach normal life. He did not approve the 911 protocol as an acceptable long-term approach to managing STUDENT’s longer seizures.
2. Dr. Gerald E. Harris is a pediatrician in private practice as well as an Assistant Clinical Professor of Pediatrics at UCSF. Dr. Harris has been STUDENT’s pediatrician since STUDENT’s birth. He sees STUDENT at six-month intervals for regular check-ups and as needed for colds and other illnesses.
Dr. Harris testified that administration of Diastat to STUDENT at school was a safer and more effective treatment for STUDENT’s seizures than calling 911. Administration of Diastat at school by properly trained personnel would ensure that STUDENT receives medication promptly and in appropriately small doses. Dr. Harris was of the belief that an LVN could administer the Diastat effectively and safely and provide respiratory intervention should it ever prove necessary. He believed that STUDENT required one-to-one nursing services in school. He was of the opinion that a registered nurse (RN) would possess far more qualifications than STUDENT required, but he had no objection to the District providing an RN for him. He recommended that STUDENT’s one-to-one service provider receive basic training in respiratory intervention with bag-valve-mask equipment. By respiratory intervention through bag-valve-mask, Dr. Harris meant a device that could be used to manually pump air into STUDENT’s lungs though a mask pressed over STUDENT’s nose and mouth.
Dr. Harris testified that waiting for the 911 services to arrive created a risk of delay in administering Diastat in a timely fashion. The use of 911 also exposed STUDENT to the risk of overdosing and would result in STUDENT’s awakening among strangers whose presence might agitate him. Dr. Harris concluded that the District’s proposal to use 911 to address STUDENT’s longer seizures is not only unnecessary but inappropriate. Given his reading of the literature on Diastat, STUDENT’s long successful history with Diastat, and the fact that it has never been necessary to administer to STUDENT the full 10 milligram dose recommended for someone of STUDENT’s weight, Dr. Harris termed STUDENT’s risk of respiratory depression, even at the frequency with which it is sometimes necessary to administer Diastat to STUDENT, as “remote” and “minuscule” because STUDENT was receiving such small doses. Dr. Harris indicated that he consults with Dr. Strober periodically and fully supports Dr. Strober’s protocol involving the VNS and Diastat.
Concerning the incident on December 10, 2001, Dr. Harris concluded that there was nothing to be alarmed about, given STUDENT’s sleeping patterns and his historical response to Diastat. Dr. Harris said that there is nothing in the records to indicate that STUDENT was not breathing properly at all times.
Dr. Harris did recommend a better communication system among all STUDENT’s care givers, particularly on the frequency and levels of the administration of Diastat.
Like Dr. Strober, Dr. Harris testified that he had approved the 911 protocol only to allow STUDENT to attend school pending what he believed would be a due process hearing to be held very shortly.
3. Dr. Michael Shore is a clinical psychologist with a specialty in neuropsychology. He was retained by Petitioner to observe STUDENT in his classroom and assess STUDENT’s developmental delays. On the day scheduled for him to observe atSTUDENT’s school, Dr. Shore arrived ten minutes prior to STUDENT. The respite-care nurse who then brought STUDENT into the schoolroom indicated that STUDENT had just suffered as short seizure while in the car. Dr. Shore found STUDENT in a postictal phase. Placed in a stroller, he was irritable, crying softly, and flailing a bit. Mr. Hall and other staff took steps to soothe STUDENT by holding him and rubbing him. These steps, which Dr. Shore characterized as sympathetic and creative, initially proved ineffective. However, Oscar, the volunteer paraprofessional, then held STUDENT, who began to calm down and focus on his surroundings. Dr. Shore stated that when STUDENT arrived at school he was in a typical postictal phase and that, once with Oscar, STUDENT was moving toward his normal “baseline” or “status quo” phase. Dr. Shore reported that he was told by Mr. Hall and staff that STUDENT might sleep the rest of the morning or doze intermittently. STUDENT was dozing when Dr. Shore left forty minutes later, after meeting with Mr. Hall and staff.
Dr. Shore described Mr. Hall as a welcoming and warm individual who had a great deal of knowledge about STUDENT’s condition. From his review of STUDENT’s records, conversations with Ms. MOTHER and Mr. Hall, and his observations of the class, Dr. Stone concluded that STUDENT is exploring his environment and is engaging in reciprocity with some of his classmates by making noises, expressing excitement, and flapping his arms. He also concluded that a familiar setting was important to STUDENT’s sense of security and, to the extent possible, STUDENT should remain in a familiar environment, have predictable routines, and avoid distressing situations. Dr. Shore indicated that Mr. Hall said that he thought that institutional and liability concerns by the District lay at the heart of the dispute and that Mr. Hall did not express any personal concerns for STUDENT’s safety if he received Diastat at school.
Dr. Shore indicated that he understood that STUDENT was a medically challenging, physically frail child. Dr. Shore indicated that children in general, and particularly children with limited comprehension, find emergency rooms frightening, isolating, and confusing and that such responses could be emotionally detrimental to STUDENT. He recommended against the use of 911 and emergency room services for STUDENT except in the instance of a genuine respiratory depression or other serious medical condition.
4. Dr. Ronald A. Dieckmann is a Clinical Professor of Medicine and Pediatrics at UCSF and the Director of Pediatric Emergency Medicine at San Francisco General Hospital. Dr. Dieckmann has trained most of the emergency medical technicians in San Francisco in emergency pediatric procedures, including when and how to administer Diastat. In general, Dr. Dieckmann is a strong supporter of the use of Diastat as the drug of choice to abort seizures in the pediatric population, although he cautioned that there is a significant risk when it is given indiscriminately to “all comers.” When given to the right type of patients, Dr. Dieckmann said, Diastat has a high safety record with little adverse effect. He characterized the general risk of respiratory depression as low, especially when given at home by well-trained family members or caretakers who carefully monitor the patient. Dr. Dieckmann indicated that children with epileptic seizures represent the lowest risk group among children with seizures who receive Diastat. While referring to the Norris article as raising a cautionary flag, Dr. Dieckmann testified that an article by Siegler, a review of thirteen rectal diazepam papers finding only three cases of reversible respiratory depression in 843 cases, was by far the most reliable indicator of the risks of Diastat.
When questioned about the high level of frequency with which STUDENT sometimes has received Diastat, Dr. Dieckmann indicated that such frequency might increase STUDENT’s risk; however, he noted that there was no reliable literature on such frequencies of use. Dr. Dieckmann did offer the estimate that STUDENT’s risk of respiratory depression might be one out of one hundred administrations, particularly if he has had a very recent previous administration of Diastat or is suffering from an illness like pneumonia. At another point in his testimony, Dr. Dieckmann indicated that STUDENT’s risk might be .3% under good conditions, such as when STUDENT was at home.
Dr. Dieckmann sought to establish that STUDENT would be at risk from Diastat if the drug were administered to him by school nurses. Dr. Dieckmann testified that the school nurses were simply not presently prepared to deal with respiratory depression and would not be able to focus effectively on STUDENT because they have numerous duties, varying levels of expertise and commitment, and the need to assist many children amid the disorder that is natural in any school. According to Dr. Dieckmann, if the school nurses were to be properly prepared to administer respiratory intervention, they would have be trained and then retrained every three to six months on how to use bag-valve-mask equipment. Dr. Dieckmann indicated that the person providing respiratory intervention to STUDENT would have to be familiar with the equipment, the appropriate volume and rate of air, the correct positioning of STUDENT, and the appropriate placement of the mask on STUDENT’s face. Dr. Dieckmann acknowledged that RNs in general (presumably those free from some or all of their responsibilities as school nurses) could be trained to fully meet STUDENT’s need for possible respiratory intervention. He was uncertain whether less qualified nurses could perform the task correctly.
On the question of what constitutes a medical emergency in STUDENT’s case, Dr. Dieckmann testified that neither the seizures themselves, unless left untreated for thirty minutes, nor the administration of Diastat at school was an emergency. According to Dr. Dieckmann, the term “emergency” is defined by the clinical circumstances, such as actual respiratory depression. He also said that the greatest danger of respiratory depression from Diastat occurs within five to twenty minutes following the administration of the drug.
Dr. Dieckmann advocated the use of 911 services for STUDENT, indicating that the average arrival rate of the 911 crews where STUDENT attends school is between three and fifteen minutes, with ten minutes the average. He indicated that the report of a child in seizure calls for a “code blue” response, with sirens and flashing lights activated on the rescue vehicles.
Dr. Dieckmann testified that emergency medical technicians on 911 vehicles are trained to check airways, administer rectal Valium at school, and, after the seizure has aborted, move the child by ambulance to a local emergency room. He defended emergency rooms as clean and safe and unlikely to administer STUDENT phenobarbital or IV Valium (both have a much higher risk of respiratory depression according to Dr. Strober and Dr. Dieckmann). He acknowledged that the activities in an emergency room can sometimes be termed well-organized chaos. Dr. Dieckmann termed 911 services for children suffering seizures in San Francisco as the “gold standard.” However, he also acknowledged that providing STUDENT at school with a one-to-one health care professional trained in how to evaluate STUDENT’s seizures, administer Diastat, and provide bag-valve-mask intervention would be “optimal.”
Whatever protocol is approved for STUDENT, Dr. Dieckmann advocated strongly that STUDENT always have with him an Emergency Information Form. An Emergency Information Form contains all the information necessary to enable an emergency medical technician unfamiliar with STUDENT to provide STUDENT with the correct intervention.
While Dr. Dieckmann identified the worst-case scenario as one in which a child stops breathing, he did not see this as a possibility sufficient to require STUDENT’s parents, care givers, or nurses to prepare for it with intubation equipment. Dr. Dieckmann testified that intubation is a highly invasive procedure and that, for a patient like STUDENT, ventilation with a bag-valve-mask would almost always be adequate. He did not foresee a scenario in which the District would need to use intubation for STUDENT if school nurses administer Diastat to him.
Dr. Dieckmann’s testimony ranged over many topics and provided a great deal of insight into 911 services and emergency room procedures. However, the points to which Dr. Dieckmann returned were two: school nurses are not currently prepared to provide bag-valve-mask services to someone suffering respiratory depression, and the use of 911 services is a simpler, more efficient, less costly approach to STUDENT’s seizures. For Dr. Dieckmann, the risk-benefit analysis dictated the use of 911 services.
Dr. Dieckmann was challenged with regard to the implications of his position concerning 911 services. His estimation that STUDENT might suffer respiratory depression one out one hundred administrations of Diastat meant that STUDENT and his family, who have already spent a nightmarish year in emergency rooms, would now (in statistical theory) have to return to 911 services and emergency rooms ninety-nine times for the one time STUDENT would have a respiratory depression at school. Dr. Dieckmann comprehended the problem. This led to an exploration among Dr. Dieckmann and the participants at the hearing on whether 911 services could administer Diastat at the school, monitor STUDENT there, and then leave STUDENT at the school when the possibility of a respiratory depression had passed. The long and the short of it was, as Dr. Dieckmann explained, that the 911 system did not possess much flexibility, that the physicians supervising the emergency medical technician (EMT) crews in the field were free to make their own decision, and that, given their training, most would order STUDENT brought to the hospital for observation.
With regard to the December 10, 2001 incident, Dr. Dieckmann indicated that the 911 crew should not have left STUDENT at school, because STUDENT might have been approaching a respiratory depression and might have benefitted from some oxygen. However, Dr. Dieckmann quickly added that he could not really speak to STUDENT’s condition because he does not know much about him. He indicated that the greatest risk of respiratory depression from Diastat occurs within five to twenty minutes following administration of the drug.
5. Ms. Jeannie McCullough-Stiles, RN, is in charge of coordinating nursing services for special education students in the District. Like all school nurses at the District, she is an independent contractor. She has held her position in the District since 1990. Her background includes experience in neurology and in adult and pediatric intensive care. One child of whom Ms. McCullough-Stiles is aware received Dilantin for seizures. The child then received Valium (whether IV or rectal was not clear) and ended up on a respirator for three days. This event sensitized Ms. McCullough-Stiles to issues surrounding treatment of pediatric seizures. Her research on Diastat for this case, which seems to have consisted primarily of locating the Norris article, also raised concerns for her, as did the information that the manufacturer and distributor of Diastat were apparently targeting schools. According to Ms. McCullough-Stiles, the use of Diastat by family and care givers to abort seizures is an “unsettled” question.
In response to questioning, Ms. McCullough-Stiles indicated that the District has no written policy on Diastat or, so far as Ms. McCullough-Stiles could learn, no list of medications that it will or will not administer, no list of drugs it is currently administering, no list of students currently receiving medications in the District, or indeed no centralized data base on what it is doing with regard to the administration of medicines to its students.
Ms. McCullough-Stiles was able to ascertain that the District has students on oxygen support and that nurses administer oxygen as needed for pulmonary hypertension, cardiac anomalies, and apnea. At least one District student is permanently on a ventilator for life support. Ms. McCullough-Stiles acknowledged that the loss of electricity to run the ventilator or a malfunction of the ventilator would require respiratory intervention to keep the student alive until a 911 crew arrived. She did not explain what respiratory intervention to sustain the life of the student would consist of.
Ms. McCullough-Stiles testified that providing bag-valve-mask ventilation for STUDENT would require a high level of skill, especially since the person or persons providing the ventilation for STUDENT would have so little occasion to practice their skills.
On the issue of whether administering Diastat was an emergency procedure, she seemed to indicate that it was an emergency in her opinion and quoted an attorney at the District as declaring “We aren’t an emergency room.”
Ms. McCullough-Stiles indicated that she made the initial decision to refuse to administer Diastat to STUDENT. She explained that her professional obligations as an RN require her to challenge a procedure that she believes is not in the patient’s best interests and, if necessary, to refuse to implement that procedure. Much of Ms. McCullough-Stiles’ testimony described the problems she encountered in obtaining reliable records on the administration of medications to STUDENT and the conversations and the meetings she attended surrounding the District’s decision to refuse to administer Diastat.
SUMMARY OF MEDICAL LITERATURE ON DIASTAT PROVIDED BY THE PARTIES
1. In Respiratory depression in children receiving diazepam for acute seizures: a prospective study, by Norris et al., Developmental Medicine & Child Neurology, 1999; 41:340-343, the authors report on the results of a study conducted between December 1996 and August 1997 in which eight out of ninety-one children (8.8%) receiving rectal Valium for seizures suffered respiratory depression. This study was conducted on children seeking services at the emergency room at the Derbyshire Hospital in England. It does not comment on the other drugs that the patients took or on co-morbidity, except to note that two of the children received paraldehyde PR before respiratory depression. Apparently, in all cases ventilation was provided with bag and mask oxygen. Responding to a letter to the editor in a subsequent issue of Developmental Medicine & Child Neurology, the authors of the Norris article acknowledge that “it would be inappropriate to extrapolate our findings from a hospital to the community” and called for further study.
2. In Rectal diazepam for pre-hospital pediatric status epilepticus, by Dieckmann RA Annals of Emergency Medicine, 1994;23:216-224, Dr. Dieckmann compares the use of IV Valium with rectal Valium in thirty-six juvenile patients who reached status epilepticus. Dr. Dieckmann defined status epilepticus as a prolonged seizure more than twenty minutes in duration or serial seizures that occur without intervening return to consciousness. The sixteen patients in the study who received rectal Valium from the paramedics had a median age of three. They all received oxygen or oxygen by bag-valve-mask, apparently as part of the emergency protocol for transporting patients with status epilepticus. None apparently suffered significant respiratory depression in the field or ambulance. At the hospital, five of the sixteen required intubation. Of these five, three had encephalitis or cerebitis; one had pneumonia; and one had hypothyroidism and chronic epilepsy. Like Norris, Dr. Dieckmann notes that there may be “biased comparisons of home-treated and paramedic-treated populations.”
3. In his testimony Dr. Dieckmann cited a 1990 study by Siegler as the most comprehensive literature review on the risk of rectal Valium. Dr. Dieckmann also referred to Siegler’s article in his own article. Neither party in this case presented the Siegler article into evidence. However given the great weight placed on this article by Dr. Dieckmann and the scope of Dr. Siegler’s review, the Hearing Officer takes official notice of Dr. Siegler’s article. In The administration of rectal diazepam for acute management of seizures, by Siegler RS, The Journal of Emergency Medicine, 1990;8:155-159, the author reviews thirteen diazepam papers and finds only three cases of respiratory depression out of 843 administrations of rectal Valium. Of the three, one had taken an earlier dose of phenobarbital and another had temperature of 104 degrees. STUDENT does not take phenobarbital or any drug other than Diastat that effects his central nervous system. He would not be in school with a fever of 104. Mr. Hall testified that no child with a possible contageous illness is allowed to attend his class. Thus for the purposes of this case, only one student comparable to STUDENT out of 843 (.12%) suffered respiratory distress.
4. In Efficacy and risk of respiratory depression with rectal diazepam use in children with epilepsy, by Gustafson et al., a paper prepared for the American Epilepsy Society’s annual meeting in Los Angeles, California, December 1 through December 6, 2000, by the Minnesota Epilepsy Group, the authors report on 532 doses of rectal diazepam administered to 78 children with age ranges from three months to twenty years. The rectal diazepam terminated prolonged or acute seizures in 96% of the cases. The authors report that the children suffered no instances of clinical respiratory depression.
5. In Treating repetitive seizures with a rectal diazepam formulation: a randomized study, by Cereghino, et al., Neurology, 1998;51:1274-1282, the authors report on the treatment with rectal Valium of 56 patients suffering acute repetitive seizures. Nine in this group were between the ages of two and six. Side effects of the rectal Valium included somnolence, headache, diarrhea, pain, and convulsion. None of the 56 patients suffered respiratory distress.
6. In Rectal diazepam gel for treatment of acute repetitive seizures, by Kriel et al., Pediatric Neurology, 1999;20(4):282-288, the authors report on 68 patients between the ages of two and seventeen who were administered rectal diazepam. Somnolence was the only side effect more common in those receiving the rectal Valium than those in the placebo-control group. None of the patients suffered respiratory distress.
7. In Home use of rectal diazepam to prevent status epilepticus in children with convulsive disorders, by Camfield et al., Journal of Child Neurology, 1989;4:125-126, the authors report on thirty children ages nine months to sixteen years whose parents received Diastat for use with the children at home. Seventeen of the families administered Diastat on the average of three treatments per patient; thirteen families never used the Diastat. The authors report no complications caused by the Diastat.
8. In An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance, by Mitchell et al., Epilepsia, 1999;40(11)1610-1617, the authors report on 149 patients age two or older who received 1578 administrations of Diastat (a median of eight treatments per patient) with no respiratory distress attributed to the rectal gel. This study followed the dosage amounts and frequencies set forth in the PDR. Thirty-three of the patients were between two and five years old.
9. In safety of Diastat when given at larger-than-recommended doses for acute repetitive seizures by Brown et al., Neurology, 2001;1112, the authors report on ten patients who received a total of 51 overdoses of Diastat. An overdose was defined as between 188% and 256% of the recommended dose. Forty of the overdoses produced no adverse reaction. Eleven overdoses were associated with side effects: bronchitis (1), convulsions (1), cough (1), fever (1), otitis media (3), somnolence (1), and vomiting (3). No adverse reactions were serious. Only the somnolence was directly attributed to the rectal Valium. None of the overdoses produced respiratory depression.
10. In A comparison of rectal diazepam gel and placebos for acute repetitive seizures, by Dreifuss et al., The New England Journal of Medicine, 1998;338(26):1869-1875, the authors report on sixty-four patients, including thirty-six children with a median age eight, who received rectal diazepam for acute repetitive seizures. The authors indicate that no respiratory depression was reported by the patients.
DISCUSSION
Under both state special education law and the federal Individuals with Disabilities Education Act (IDEA), students with disabilities have the right to a free appropriate public education (FAPE). 20 U.S.C. § 1400(d); California Education Code § 56000. The term “free appropriate public education” means special education and related services that are available to the student at no charge to the parent or guardian, that meet the state educational standards, and that conform to the student’s individualized education program (IEP). 20 U.S.C. § 1401(8). “Special education” is defined as specially designed education, at no cost to the parents, to meet the unique needs of the student. 20 U.S.C. § 1401(25); California Education Code § 56031. “Related services” means transportation and other developmental, corrective, and supportive services that may be required to assist the child to benefit from special education. 20 U.S.C. §1401(22). Related services include “school health services . . . provided by a qualified nurse or other qualified person.” 34 C.F.R. § 300.24(b)(12). Related services exclude medical services except for purposes of diagnosis and evaluation. 20 U.S.C. § 1401(22). State law similarly provides that designated instruction and services (DIS), the State’s term for related services, shall be provided “when the instruction and services are necessary for the pupil to benefit educationally from his or her instructional program,” and include health and nursing services. California Education Code § 56363(a).
In Board of Educ. of the Hendrick Hudson Central Sch. Dist. v. Rowley, 458 U.S. 176, 200, (1982), the United States Supreme Court addressed the level of instruction and services that must be provided to a student with disabilities to satisfy the requirements of the IDEA. The Court determined that a student’s IEP must be reasonably calculated to provide the student with some educational benefit. The Court stated that school districts are required to provide a “basic floor of opportunity” that consists of access to specialized instruction and related services which are individually designed to provide educational benefit to the student. Id. at 201.
Under California law, health and nursing services include “health services prescribed by the child’s licensed physician and surgeon requiring training for the individual who performs the services and which are necessary during the school day to enable the child to attend school.” 5 C.C.R.§ 3051.12. California law provides that “health and nursing services” shall be provided by (1) a registered nurse, (2) a licensed vocational nurse supervised by a registered nurse, (3) a person possessing a school nurse credential, (4) someone properly trained and possessing “demonstrated competence in cardiopulmonary resuscitation, current knowledge of community emergency medical resources, and skill in the use of equipment and performance of techniques necessary to provide specialized physical health care services for individuals with exceptional needs,” and (5) someone with a valid license, certificate, or registration appropriate to health services to be delivered and issued by the appropriate California agency authorized to issue such a credential. 5 C.C.R. § 3065(h).
Health and nursing services for special education children have long been a matter of contention. In Irving v. Tatro, 468 U.S. 883 (1984), the Supreme Court determined that the IDEA required the Irving Independent School District to provide clean intermittent catheterization to eight-year-old Amber Tatro, born with spina bifida. In so holding, the Court determined that any service that could properly be termed a “related service” and could not be termed a “medical service” was the responsibility of a school district. The Court clearly identified medical services as those services that can only be performed by a qualified physician. The Court commented that “a service that enables a handicapped child to remain at school during the day is an important means of providing the child with the meaningful access to education that Congress envisioned.” 468 U.S. at 891.
A number of the circuit courts of appeal construed Tatro as creating or authorizing a multifactor test to use in determining what constitutes “medical services,” services for which school districts are not responsible. See, e.g. Neeley v. Rutherford County Schools, 68 F.3rd 965 (6th Cir. 1995), cert. denied 517 U.S. 1134 (1996). These circuit courts identified as significant such factors as the nature and complexity of the disability, whether the service is continuous or intermittent, whether existing school health personnel are able to provide the services, the cost of the services, and the consequences to the student if the services are not properly performed. Any of these factors could convert a related service that a school district was required to provide into a medical service the school district did not have to provide.
In Cedar Rapids Community School District v. Garret F., 526 U.S. 66 (1999), the Supreme Court revisited the issue of related services versus medical services. Garret F. was paralyzed from the neck down as a result of a motorcycle accident. He was dependent on an electric ventilator to maintain his life. He needed one-to-one nursing services to monitor his ventilator, to provide manual pumping of air through a bag attached to his tracheal tube when the ventilator was being serviced, and to respond to problems and emergencies that might arise from ventilator malfunction, loss of electricity, or autonomic hyperreflexia, a sudden and severe rise in blood pressure that can cause stroke or death. In deciding whether the school district was required to provide such services to Garret, the Court swept away any doubts about multifactored tests and reaffirmed the “bright line” test of Tatro. The Court concluded that medical services under the IDEA are only those services that must be performed by a licensed physician; all other health-related services that fall within the category of related services are the responsibility of the school district.
The facts in Cedar Rapids are instructive to the case at hand. The Supreme Court clearly recognized that Garret faced a life-threatening risk while at school and envisioned the possibility of a medical emergency. A malfunction of the ventilator or the loss of electricity would require Garret’s one-to-one nurse to provide emergency ventilation to keep him alive until the problem with the ventilator was corrected or emergency services arrived. This supplemental ventilation was to be performed manually by “ambu-bag.” Garret could also suffer autonomic hyperreflexia. A full bladder or impacted bowel are the usual cause, and emptying the bladder (by adjusting the catheter) or digitally emptying the bowel can cause the symptoms to subside. However, other health problems can cause autonomic hyperreflexia. If the problem cannot be quickly identified and corrected, then emergency medical treatment must be obtained immediately. In other words, if Garret suffered a problem with his ventilator or autonomic hyperreflexia, he would require swift competent intervention and, if that intervention failed, prompt emergency services. Garret had not suffered autonomic hyperreflexia in recent years but the risk remained.
The Supreme Court was well aware of the risks to Garret. The brief submitted by the Cedar Rapids Community School District to the Supreme Court emphasized that Garret could die if his “breathing were interrupted for just a few minutes,” and that autonomic hyperreflexia is “a life threatening” medical condition. Petitioner’s Brief, pp. 39 and 35. The Court acknowledged the complexity of Garret’s condition and the risks to Garret’s life when it quoted from the findings of the administrative law judge (ALJ) who originally heard the case. According to the ALJ, Garret needs someone to address ventilator problems and “someone who could perform emergency procedures in the event he experiences autonomic hyperreflexia.” Cedar Rapids, 526 U.S. at 68 n.3. In reaffirming the “bright line” test of Tatro, the Court also reaffirmed the position that services that enable a disabled child to remain in school during the day provide the meaningful access that Congress intended. In so holding, the Court rejected complex tests of when services must be provided by school districts in favor of a simple test that provides school districts clear notice of their obligations.
STUDENT’s Unique Needs
With Cedar Rapids as a guide, we can now turn to an examination of STUDENT’s health care needs. While disputing who must provide them, the parties agree that STUDENT requires the following servces:
1. Coordinating with STUDENT’s parents and GGRC nurses
2. Providing water and medicine through his G-tube
3. Feeding
4. Monitoring of his general condition
5. Placing STUDENT on his side in a secure location and loosening his clothing when a seizure occurs
6. Swiping the VNS
7. Administering Diastat
8. Monitoring the effects of the Diastat for failure to abort the seizure and for adverse reactions
9. Administering ventilation assistance, if needed
10. Calling 911, if needed
None of these tasks requires the training, knowledge, or judgment of a licensed physician. All of them, except ventilation assistance, are being performed by STUDENT’s mother and LVNs. Indeed, with the exception of swiping the VNS and the administration of the Diastat, there is nothing in this list that District nurses are not already doing for other students. The District has assented to swiping the VNS. The only task at issue is the actual administration of the Diastat, a task so simple that Ms. MOTHER and the GGRC nurses perform it without difficulty. Thus, it is clear that the services STUDENT requires are not medical services and fall on the District’s side of the “bright line.”
Both the District’s 911 protocol and Dr. Strober’s protocol meet these general requirements. However, STUDENT’s needs extend beyond these narrow health care functions. The testimony from Mr. Hall, Ms. MOTHER, and Dr. Shore establishes that STUDENT, to the extent feasible, needs to be treated by familiar people and recover from seizures in a quiet, familiar setting among familiar people. STUDENT should not be unnecessarily subjected to strangers in a strange setting amid strange activities and noises. While it is not possible to ascertain the exact nature of the trauma STUDENT experiences in an emergency room, it is clear that he suffers substantial stress and anxiety there. The District’s protocol does not take STUDENT’s response to emergency services into account.
STUDENT’s unique needs extend to his parents. Under California special education law, services to children between the ages of three and five “shall include specially designed services to meet the unique needs of preschool children and their families.” California Education Code § 56441.2 (emphasis added). One specific purpose for providing for the unique needs of families of young children like STUDENT is to “reduce family stresses.” California Education Code § 56441.
STUDENT’s parents have already suffered a nightmarish year of 911 calls, emergency room visits, and attendant long waits and anxiety over whether STUDENT is receiving proper treatment by 911 crews and emergency room staffs. The parents in consultation with Dr. Shore chose to use Diastat to avoid further unnecessary encounters with emergency services. The parents expressed a need to know that STUDENT will be looked after and ministered to by people who are familiar with him and who the parents, as well as STUDENT, know and trust. The parents need to know that STUDENT will be spared the trauma of unnecessary emergency services. They themselves need to avoid further lengthy stays at the emergency room and possible unnecessary absences from their jobs. Although STUDENT is currently attending school, Ms. MOTHER indicated that she will be forced to remove him if he suffers serious seizures at school and is automatically turned over to 911 services.
The District’s protocol of 911 fails to meet STUDENT’s needs in a number of ways: STUDENT will not be allowed to remain in school and awaken in a familiar setting surrounded by familiar people; STUDENT will be subjected to the stresses and possible mistakes of emergency services; STUDENT’s parents will suffer anxiety over how STUDENT will be treated by emergency personnel and feel compelled to leave their jobs and rush to the emergency room; and STUDENT’s parents, or at least one of them, will have to take substantial time from work until STUDENT is released from the emergency room and then transport him to his respite nurse.
On the other hand, Dr. Strober’s protocol clearly meets the unique needs of STUDENT and his parents by addressing STUDENT’s health problems along with his need to remain in his school room among familiar people and avoid the stresses of unnecessary emergency room visits while sparing his parents worry and long aggravating hours waiting in emergency rooms.
Meaningful Access to Education and Educational Benefit
The District argues that STUDENT may be unconscious or asleep during his seizures and thereafter. That will probably be the case more often than not. The District asserts that STUDENT will not know what is going on during the administration of emergency services and that, therefore, its 911 protocol does not affect STUDENT’s meaningful access to special education or deprive him of educational benefit. “Meaningful access” is not a static concept, however; it requires different responses for different children. For STUDENT, being in a familiar and predictable setting with familiar and trusted teacher and care givers is the core of his educational experience. As Mr. Hall and Dr. Shore testified, STUDENT’s sense of predictability and security is what enables him to be alert to his surroundings, play with toys, and watch and mimic other children. For STUDENT, recovering from a seizure in the schoolroom with familiar people (or with his respite nurse who delivers him from school) reassures him that school is a safe place, a place where he can explore the world and receive educational benefit. See Rowley 458 U.S. at 200. Remaining at school is part of “meaningful access” for STUDENT. Remaining at school gives STUDENT the opportunity to receive educational benefit. As the Supreme Court noted in Tatro, “Services . . . that permit a child to remain in school during the day are no less related to the effort to educate than are services that enable the child to reach, enter, or exit the school.” 468 U.S. at 891.
The Hearing Officer concludes that, subject to District’s arguments discussed below, the implementation of Dr. Strober’s protocol by qualified district personnel is a service necessary to meet STUDENT’s unique needs, to provide STUDENT with meaningful access to education, and to assist STUDENT to benefit from his special education under Rowley, Tatro, and Cedar Rapids and, therefore, is a related service that the District must provide STUDENT. 20 U.S.C. § 1401(2); California Education Code §§ 56031 and 56363(a). The Hearing Officer next examines the District’s arguments as to why special education law does not apply to STUDENT’s case.
The Risk of Diastat
The District argues that the possibility of respiratory depression and the need to provide respiratory intervention places the administration of Diastat outside the scope of special education services and the holdings of Tatro and Cedar Rapids. The District cited no authority for the proposition that dangerous drugs may be excluded from related services. Nevertheless, it is a credible proposition. The Hearing Officer will assume that the administration of a dangerous drug falls outside the scope of related services and the IDEA and will address the question of whether or not Diastat is an appropriately safe medication.
The literature on the safety of Diastat, as well the testimony of Dr. Strober, Dr. Harris, and Dr. Dieckmann, overwhelming established that Diastat is a generally safe drug to abort seizures in pediatric epileptic patients. Diastat is a safe and effective medication that can be administered by parent, care giver, and trained school personnel. Contrary to Ms. McCullough-Stiles’ assertion, the use of Diastat is not an open question.
The literature does not address the frequency with which STUDENT has sometimes used Diastat in the past and might be forced to use it again – two to three times a week and eight to twelve times a month. It is highly unlikely that the District would be called upon to administer Diastat this frequently. However, the District could find itself administering the second or third treatment of Diastat within a week or participating in the administration of Diastat more than five times a month. Both Dr. Strober and Dr. Harris noted that STUDENT almost never receives more than half the maximum dose recommended for a child his age and weight. They also noted that STUDENT has never suffered respiratory depression from Diastat and has no history of respiratory distress. They concluded that the risks of STUDENT’s taking Diastat at the frequency with which he took it during the months of September through December were minimal. Dr. Dieckmann testified that he believed that there would be some increase of risk to STUDENT over that identified for patients receiving amounts recommended in the PDR. According to Dr. Dieckmann, STUDENT’s risk of respiratory distress as a result of the frequency with which he received it September through December 2001, might be one in one hundred treatments.
On the basis of the literature reviewed above, and particularly on the basis of the testimony of the three physicians, the Hearing Officer concludes that the protocol established by Dr. Strober (with its caveat against administration of Diastat twice within twenty-four hours) does not place STUDENT at great risk and that what risk there is can be effectively managed by a trained professional able to administer bag-valve-mask intervention.
The risk to STUDENT bears comparison to the risks faced by Garret F. Both boys live with the risk that they may require emergency ventilation intervention and possible emergency services. Although Garret has the distinct advantage of having normal intelligence and being able to speak, in certain ways Garret’s risks are greater than STUDENT’s because he is totally dependent on his ventilator for his life. He lives with the constant specter that his ventilator or the electricity that powers it will fail. His recourse is the ambu-bag and possible emergency services. Garret also risks an attack of autonomic hyperreflexia, which must be addressed quickly and may require hospitalization. STUDENT’s risks are that he will suffer a prolonged seizure and the Diastat either will not end the seizure or will cause respiratory depression. If the Diastat fails to abort STUDENT’s seizure, 911 must be called. If STUDENT suffers respiratory depression, he too will require an ambu-bag or similar ventilator and a call to 911. Both boys are vulnerable, dependent, and at risk of an emergency. In neither instance, however, is the risk so great that school nurses properly trained cannot handle the situation until emergency services arrive. Neither the use of Diastat in general nor the frequency with which STUDENT has received it in the past constitutes a danger to STUDENT that might place the administration of Diastat to STUDENT outside the scope of the IDEA, as interpreted in Tatro and Cedar Rapids.
The District’s Claim of An Emergency Exception
The District argues that STUDENT’s prolonged seizures and the administration of Diastat are “medical emergencies” in themselves. As such, the District argues, they place this case beyond the scope of the IDEA and Tatro and Cedar Rapids. The District cites no authority for this proposition. However, it is reasonable to conclude that a medical emergency may place a special education student outside the purview of an IEP and that the emergency must be dealt with according to accepted emergency medical procedures. Accordingly, the Hearing Officer will assume arguendo a medical emergency exception to special education law and analyze STUDENT’s case accordingly.
Dr. Harris and Dr. Strober testified that neither the seizure themselves (unless left untreated) nor administrations of Diastat are medical emergencies. Dr. Strober apparently indicated to representatives of the District that the administration of Diastat might be placed somewhere on a spectrum of emergency medicine. However, at the hearing, he was very clear that the administration of Diastat by itself was not an emergency, but an effective treatment to prevent an emergency. Perhaps most significantly, Dr. Dieckmann, who specializes in emergency medicine, testified that neither STUDENT’s seizures nor administrations of Diastat were emergencies. In Dr. Dieckmann’s view, an emergency would occur only if STUDENT suffered a respiratory depression or comparable complication. In short, the three doctors agreed that neither the seizures by themselves nor the administrations of Diastat are emergencies.
The testimony of the three doctors persuades the Hearing Officer that there is no emergency unless STUDENT suffers a respiratory depression or similar complication. Thus, even if the IDEA, Tatro, and Cedar Rapids exclude emergency services as related services, the treatment of STUDENT’s seizures with Diastat and the monitoring of him for respiratory depression do not fall within the category of excluded emergency services. The fact that STUDENT may be groggy or in a deep sleep following a seizure or the administration of Diastat does not alter this conclusion. Short-term seizures can have a comparable effect on STUDENT. As with Garret F., STUDENT needs someone to keep an eye on him at all times.
The District attempted to give great significance to STUDENT’s seizure and postictal status on December 10, 2001. Dr. Harris and Dr. Strober testified that the event was not a cause for concern. Dr. Dieckmann raised the possibility that STUDENT might have benefitted from some oxygen that day and might have been somewhere on a continuum leading to respiratory depression. However, he acknowledged that he really could not speak to STUDENT’s condition since he had never seen him. Dr. Dieckmann also testified that the period of five to twenty minutes following the administration of Diastat is the time when respiratory depression occurs. The reports prepared by Ms. Cleghorn and Ms. Thomas were based on an examination of STUDENT that occurred approximately one and one-half hours after STUDENT received the Diastat and approximately twenty-five minutes before STUDENT recovered consciousness on his own. Thus the examination took place well outside the time frame Dr. Dieckmann identified as the period that respiratory depression was most likely to occur and shed no light on possible respiratory depression.
On the basis of the testimony of Dr. Harris and Dr. Strober, the evidence on STUDENT’s postictal phase, his heavy sleep, and his response to Diastat, the Hearing Officer concludes that the events of December 10 did not constitute an emergency. Indeed, the Hearing Officer is persuaded that STUDENT was safe at all times on December 10 and that his postictal condition following his seizure and the administration of Diastat was within his normal (and safe) range of responses to a significant seizure and an administration of Diastat.
The District’s Argument on the Limitations in the Administration of Prescribed Medications Under Guidelines Issued by the California Board of Registered Nurses
The District asserts that guidelines from the California Board of Registered Nurses give registered school nurses operating in the field of special education the authority to determine whether or not a doctor’s order is to be implemented in school, even if the prescription is otherwise part of a related service. The District argues that Ms. McCullough-Stiles rejected Dr. Strober’s protocol on the basis of her authority as a registered nurse and that she has such authority independent of special education law.(Footnote 7) The District cites as authority guidelines on the “Acceptance and Implementation of Orders” issued by the California Board of Registered Nursing.(Footnote 8) These guidelines read, in pertinent part:
ASSESSMENT
The RN is to assess all orders before implementation to determine if the order is
• in the client’s best interest;
• initiated by a person legally authorized to give direction for client care to an RN, i.e., physicians, dentists, podiatrists, clinical psychologists and nursing orders initiated by RNs;
• in accordance with all applicable statutes, regulations and agency policies.
ACTION
If the order is consistent with the aforementioned criteria, the RN may either implement the order or delegate the implementation to the appropriate person(s). In the event that any of the criteria are not met or if there is any confusion, doubt or misunderstanding about the order, the RN is to seek clarification of the order. This may include the physician, the initiator of the order, nursing supervisor or other authorized clinical officer. Clarification is to be obtained prior to implementation of the order. The Board requires that the RN act as the client’s advocate by challenging, and if appropriate, changing decisions or activities which in the nurse’s judgment do not meet the assessment criteria previously listed. The RN actions in challenging and or changing an order should be in conformance with any agency policies and procedures.
NURSING ADMINISTRATORS
Nursing supervisors and administrators play a crucial role when orders are appropriately challenged by a RN. The Board expects nursing supervisors and administrators to support the RN in not implementing an order which is not in the client’s best interest and/or does not meet the assessment criteria previously listed. Furthermore, the Board encourages nursing administrators to have written policies and procedures which define the process and channels of communication for the challenging and changing of orders by RNs.
According to the District, these guidelines not only authorized but compelled Ms. McCullough-Stiles to refuse to administer Diastat to STUDENT. If STUDENT’s parents are dissatisfied with this decision, the District’s closing brief argues, the parents should take the matter up with the Board of Registered Nurses. In fact, for this reason, the District asserts that the California Special Education Hearing Office has no jurisdiction over this case.(Footnote 9) In the District’s view, the case is really about the duties and authorities of registered nurses and not about STUDENT’s special education.
The implications of this argument are disturbing and, ultimately, self-defeating. In effect, each and every registered nurse working for a school district in California, including independent contractors such as the registered nurses working for the District, could refuse to implement a protocol or administer medicine or services on the ground that the services or medicine are not in the student’s best interest. Parents would have no recourse through a special education due process hearing, despite the fact that nursing services are clearly a related service under the IDEA and California special education law. The predictable result would be different decisions by different nurses in different school districts. A student might be effectively barred from attending school by a nurse in one school district but allowed to attend school by a nurse in another district. Another consequence of this theory is that a California school nurse could find that the various orders and protocols issued by doctors for a student in California like Garret F. were not in his best interest and refuse to implement them, effectively barring the student from attending school. All of this would happen, according to the District’s argument that the school nurse operates outside the bounds of special education, without an IEP team decision (other than one dictated by the school nurse) or recourse to a special education due process hearing. There is no authority cited by the District and nothing in the history of the IDEA or California special education law to suggest that either Congress or the California Legislature intended such startling results.
Moreover, there is nothing in the law to indicate that school districts can evade their responsibilities to special education students by hiding behind the authority of RNs. Indeed, contrary to the District’s argument, it appears that the District itself made the decision to refuse to administer the Diastat to STUDENT. According to the testimony of Ms. Joyce Eckrem, an attorney for the District, she and not Ms. McCullough-Stiles made the decision on behalf of the District to deny administration of Diastat. The views of Ms. McCullough-Stiles were just one of a number of factors Ms. Eckrem indicated that she considered. In other words, the District did not act as if it were obligated to follow Ms. McCullough-Stiles’ decision. It is apparent that the District does not really believe that it must allow a school nurse to make a decision involving the education of a disabled student for which it might be liable.
The District’s argument on this issue fails. See Cedar Rapids.
Other Possible Limitations on the Administration of Prescribed Medications
The question remains: Must school districts and school nurses follow all medical orders and prescriptions for special education students that require implementation during the school day that are not dangerous or not an emergency procedure? Do doctors simply have a free hand to impose responsibilities on school districts? When a dispute arises, what entity resolves the dispute?
The law affords parents of a special education student a due process hearing to “present complaints with respect to any matter relating to the identification, evaluation, or educational placement of the child, or provision of a free appropriate public education of [their] child.” 20 U.S.C. § 1415(b)(6) (emphasis added). In this case, the question of whether STUDENT must go to the emergency room for every lengthy seizure when he could receive effective treatment from qualified and familiar people within the confines of his classroom clearly “relates” to the appropriateness of STUDENT's special education. Therefore, the California Special Education Hearing Office has jurisdiction over this case.
The issue then becomes, what criteria are to be used by the Hearing Officer in resolving the question. Special education law has little to say on the subject, once a service is determined to be a related service. In this case, the District has no written policies limiting the administration of prescription drugs or other nursing services prescribed by physicians.(Footnote 10) However, the California Legislature is aware of the problem that prescriptions present. In 2000, the Legislature delegated to the State Board of Education the duty of adopting regulations regarding the administration of prescribed medication in public schools. The Legislature envisioned broad input into the regulations by interested parties including the Advisory Commission on Special Education. The provision delegating the task of developing these regulations, California Education Code § 49423.6, reads as follows:
(a) On or before June 15, 2001, the State Department of Education shall develop and recommend to the State Board of Education and the board shall adopt regulations, regarding the administration of medication in the public schools pursuant to Section 49423. [Section 49423 authorizes schools to administer properly prescribed medication.] These regulations shall be developed in consultation with parents, representatives of medical and nursing professions, and other individuals jointly designated by the Superintendent of Public Instruction, the Advisory Commission on Special Education established pursuant to Section 33590, and the Department of Health Services. The Board of Registered Nurses may designate a liaison to consult with the Board of Education in the adoption of these regulations.
(b) Any regulations adopted pursuant to this section shall be limited to addressing the situation where the pupil’s parent or legal guardian has initiated a request to have a local education agency dispense medicine to a pupil, based on the written consent of the pupil’s parent or legal guardian, for a specified medicine with a specified dosage, for a specified period of time, as prescribed by a physician or otherwise authorized medical personnel.
As of the date of this decision, the mandated regulations have yet to be adopted.(Footnote 11) However, it is difficult to conclude that the regulations would create a straightjacket by imposing standards such as those contained in the PDR. Drugs approved by the Food and Drug Administration are regularly used by physicians for purposes for which they were not originally approved. As new uses are found for drugs, doctors prescribe the drugs for these uses. The manufacturers of drugs do not return to the Food and Drug Administration (FDA) for approval of new uses, primarily because of economic reasons, and because they are not required to do so. Thus, in modern American medicine, antihistamines are used as sleeping medicine, drugs for seizures and high blood pressure are used to prevent migraines, Ritalin is used to combat depression in older people, and antidepressants are used to combat seizures. No one argues that this general approach to the prescription of medicines is improper, absent special factors. Neither federal nor State law prohibits the use of prescription medications in amounts and for uses for which they were not approved by the FDA. See Tabarrok AT. Assessing the FDA via the anomaly of off-label drug prescribing. 2000;5(1):25. For many disabled children, the administration of drugs for purposes for which they were not originally approved or in amounts not originally recommended is almost certainly necessary to allow them to attend school and to benefit from their special educations. In any case, the State regulations, which will cover both regular students and special education students, will presumably be subject to review under the IDEA.
It is reasonable, nevertheless, to assume that some general limitations on the administration of prescription medications to all special education students might be permissible under the IDEA. For example, a prohibition on experimental drugs or the use of drugs for a purpose not generally accepted by the medical community might constitute a reasonable limitation that applies to all special education students.
However, given the record in this case, the Hearing Officer finds no use of experimental drugs, no unorthodox use of approved drugs, no drugs prescribed by a physician outside of his or her area of expertise, no protocol inconsistent with generally accepted medical practices for a child suffering seizures for which no preventive regimen has been found, and no protocol or prescription contrary to STUDENT's best interest. Therefore, the Hearing Officer finds no reason to deny STUDENT the benefit of Diastat at school.
CONCLUSION
The implementation of Dr. Strober’s protocol for use of the VNS and administration of Diastat by qualified District personnel is necessary to make public education meaningfully accessible to STUDENT. Rowley, 458 U.S., at 192; Tatro, 468 U.S., at 891; Cedar Rapids, 526 U.S., at 73. The protocol is necessary to meet STUDENT's unique needs and afford him educational benefit. 20 U.S.C. § 1401 (25); California Education Code § 56031; Rowley, 458 U.S., at 198-200. The protocol, therefore, is a related service the District must provide. 20 U.S.C. § 1401(2); California Education Code §§ 56031 and 56363(a).
For the remainder of the school year, including the extended school year, the District must arrange services for STUDENT that include the administration of Diastat pursuant to Dr. Strober’s protocol as it presently exists and as Dr. Strober may modify it.(Footnote 12) Drs. Strober, Harris and Dieckmann all agreed that STUDENT needs one-to-one services to address his health needs if he receives Diastat in school. The Hearing Officer is persuaded by the testimony of the doctors and the totality of the evidence, including STUDENT’s frailty and the uncontrolled nature of his seizures, that STUDENT requires one-to-one services throughout the school day to monitor his health generally, including his lesser seizures and propensity to cough and gag, to ensure the administration of Diastat if needed, and to administer ventilation intervention if needed. This one-to-one requirement is a related service. This service is not an emergency service, high-risk service, or service improperly prescribed by a physician. This service has been approved by doctors Harris, Strober and Dieckmann and is educationally and medically reasonable, Ms. McCullough-Stiles’ views notwithstanding. If Ms. McCullough-Stiles believes that she cannot adhere to the requirements of this Decision in good faith, the District must make other personnel arrangements. (Footnote 13)
The evidence as to the credentials required of the personnel to deliver STUDENT’s ono-to-one services is inconsistent. Dr. Harris recommended an LVN or “other qualified aide.” Dr. Strober called for an aide with a nurse on the school site, or a one-to-one nurse. Dr. Dieckmann indicated that an RN was probably necessary to administer ventilation services, but accepted the proposal by STUDENT’s attorney for a trained one-to-one “health care professional.” On the basis of this testimony, the Hearing Officer concludes that at a minimum STUDENT requires the services of a trained one-to-one aide with a nurse immediately available at all times to assist STUDENT and the (1) aide by swiping the VNS, (2) administering Diastat, (3) monitoring the effect of the Diastat, and (4) making the determination that STUDENT is responding properly or calling 911 and administering ventilation assistance with bag-valve-mask if needed until 911 services arrive. More than one aide and more than one nurse must be prepared to provide STUDENT’s one-to-one service in case of an absence by an aide or nurse. In addition, the District must assign personnel that regularly work with STUDENT so that they become familiar with him and he becomes comfortable with them. The IEP team is in the best position to determine the credentials of the aides, and, if the aides are not nurses, the credentials of the nurses. The Hearing Officer assigns this responsibility to the IEP team. The IEP team is free to decide that the one-to-one services are to be provided by an LVN or RN.
The general approach to STUDENT’s care that the Hearing Officer adopts is set forth clearly in the Brief of Amicus Curiae for the American Academy of Pediatrics, the National Association of School Nurses, and the Family Voices in Support of Respondent (Garett F.) in the Cedar Rapids case:
The role of the primary care physician under these circumstances is to coordinate the health care Garret receives, both at home and at school. The overall direction of medical care and health related services for children with chronic and disabling conditions is the responsibility for the primary care physician and the medical community, wherever the services may be provided, and whoever may provide them. It is important that the child’s personal physician and the school physician, the school nurse, the school administrator and the family develop a written health plan as an integral component of the child’s individual education plan (IEP). Thus, it is the role and responsibility of a child’s primary care physician to inform the school health professionals about the child’s medical needs and child’s degree of fragility.
Working with this information, school health professionals (e.g., physicians or nurses) can decide whether services should be provided by a nurse or delegated to an adequately trained and appropriately supervised health professional. The specific decisions with respect to whether a registered nurse, license vocational nurse, or other health professional is required must be made on a case by case basis and must be redetermined whenever there is a change in the child’s condition.
This is the approach that the District must follow for STUDENT. For issues surrounding STUDENT’s seizures and the administration of Dusted, Dr. Strobe is to be regarded as the primary care physician.
Important matters that remain to be addressed are the limited record keeping on the administration of Dusted to STUDENT, the recommendation for an Emergency Information Form for STUDENT made by Dr. Dieckmann, concerns over STUDENT’s postictal condition, apparent confusion over Dr. Strober’s current protocol, the concerns over STUDENT receiving two treatments of Diastat within twenty-four hours, and the need for District personnel to receive ventilation training.
Specifically, STUDENT’s parents, Dr. Strober, GGRC, and the District must collaborate to develop an Emergency Information Form for STUDENT in case 911 is called. This form should be kept with STUDENT at all times and, specifically, when he is at school.
The parties must develop a practical log in which to systematically record all seizures STUDENT suffers, their time and length, the swipes of the VNS, the amount of Diastat administered, and the time it was administered. The parties are encouraged to add other useful categories of information. This log must be kept current on a daily basis by STUDENT’s parents, GGRC respite nurses, and school personnel and must accompany STUDENT to school every day.
The District must keep STUDENT in school when he is groggy, sleepy or in a postictal state as a result of seizures and possible administrations of Diastat, subject to consultation with Dr. Strober or Dr. Harris, a clear emergency, or an illness unrelated to STUDENT’s seizures. Grogginess, sleepiness and the postictal phase of recovery are part of STUDENT’s disability. Typically, he will be alert to his teacher, classmates, and surroundings at least part of every day and, therefore, derive educational benefit.
The District must consult with either Dr. Strober or Dr. Harris before reaching any general conclusion that STUDENT is too weak or too ill from seizures or the use of Diastat to continue to attend school for a period of time.
The District must be immediately provided with any change to Dr. Strober’s protocol by STUDENT’s parents or Dr. Strober. Any confusion over the current protocol can be cleared up at the IEP team meeting ordered below.
The aides and nurses who provide STUDENT’s full-time one-to-one services must be fully briefed on all aspects of STUDENT’s condition, and the nurses must receive proper training in bag-valve-mask ventilation for STUDENT and the proper equipment.
The District should invite Dr. Strober to play an active role in assisting the District to meet the requirements of this Decision.
To implement these requirements, the District must convene an IEP team meeting to modify the existing IEP accordingly. Dr. Strober and representatives of the GGRC must be invited to attend this meeting. The revised IEP must contain all the requirements set forth in this Decision.
Given the complexity of this case, the personal, professional and institutional tensions surrounding it, and STUDENT’s condition, it is important to note what the Hearing Officer has not decided.(Footnote 14) He has not concluded that all special education students with seizures require one-to-one services or the administration of Diastat at school. He has not determined what effect State regulations or written school policies, especially if adopted pursuant to State regulations, might have on the administration of prescription medications to special education students. He has not concluded that a school district must follow all prescriptions and protocols of doctors for special education students that fall into the category of related services; school districts have the authority to challenge the orders of doctors through the due process hearing system if necessary. He has not determined when STUDENT’s condition might render him too weak or ill to attend school. The Orders issued in this Decision stand only for the remainder of the 2001-2002 school year, including the extended school year, subject to any significant change in STUDENT’s condition.
ORDER
1. The District shall provide STUDENT with one-to-one health care services to administer food and fluids, address any coughing, gagging or vomiting, monitor STUDENT’s condition throughout the school day, administer Diastat if needed, in accordance with Dr. Strober’s most current protocol, and provide emergency ventilation services if needed. These services include the services of nurses who must be immediately available to address all issues involving STUDENT’s seizures. The District shall provide these services for the remainder of the 2001-2002 school year, including the extended school year.
2. Within 10 calendar days of the date of this Decision, the District shall convene a meeting of the IEP team. The IEP team must bring the current IEP into conformity with this Decision. The IEP team shall develop for STUDENT:
(a) an Emergency Information Form along with a procedure to ensure that the Form remains with STUDENT at all times.
(b) a log in which STUDENT’s parents, caretakers and District personnel record on a daily basis all of STUDENT’s seizures, including their time and length, the time and frequency of the swiping of the VNS, the time and dosage of the administration of Diastat, and any other information the IEP Team determines appropriate.
(c) accommodations for periods when STUDENT is groggy, asleep, or in a postictal condition as a result of a seizure or the administration of Diastat.
(d) a program of one-to-one health care services for STUDENT provided at all times during the school day by qualified individuals assigned to work with STUDENT on a regular basis. At a minimum, this program shall provide STUDENT with the services of a one-to-one aide with a qualified nurse immediately available at all times to assist STUDENT and the aide by handling all issues involving a significant seizure (one of five minutes or longer), including:
• evaluating any seizure
• swiping the VNS
• administering Diastat if needed
• monitoring the effect of the Diastat
• and making the determination that STUDENT is responding properly to the Diastat or, if not, calling 911 and administering ventilation intervention if needed until the 911 team arrives.
(e) a staffing plan that provides more than one aide and more than one nurse in case of an absence of an aide or nurse.
(f) a training program that ensures that STUDENT’s aides and nurses are fully informed on STUDENT’s condition and that STUDENT’s nurses are properly trained in bag-valve-mask ventilation for STUDENT, and are provided appropriate ventilation equipment for STUDENT.
3. The IEP team is free to decide that all of STUDENT’s health care services will be provided by qualified nurses.
4. The District must invite Dr. Strober and representatives of GGRC to the IEP team meeting. The District must schedule the IEP team meeting at a time and place that permits Dr. Strober and representatives of GGRC to attend.
5. The District shall fully implement the revised IEP within 5 calendar days of the IEP meeting.
PREVAILING PARTY
Pursuant to California Education Code § 56507(d) the hearing decision must indicate the extent to which each party has prevailed on each issue heard and decided. In this case, Petitioner prevailed on the only issue heard and decided.
RIGHT TO APPEAL THIS DECISION
The parties to this case have te right to appeal this decision to a court of complete jurisdiction. If an appeal is made, it must be made within ninety (90) days of receipt of this Decision. California Education Code § 56505(i).
DATED: March , 2002 ____________________________
Edwin Villmoare
Chief Hearing Officer
California Special Education Hearing Officer
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