Findings Of Fact At all times relevant hereto Daniel Francis Sanchez was licensed as a physician by the Florida Board of Medical Examiners having been issued license number ME0038795. At all times relevant hereto Respondent was Regional Medical Director of IMC which operated HMO offices in Hillsborough and Pinellas Counties. On October 17, 1985, Alexander Stroganow, an 84 year old Russian immigrant and former cossack, who spoke and understood only what English he wanted to, suffered a fall and was taken to the emergency room at Metropolitan General Hospital. He was checked and released without being admitted for inpatient treatment. Later that evening his landlady thought Stroganow needed medical attention and again called the Emergency Medical Service. The ambulance with EMS personnel arrived and concluded Stroganow was no worse than earlier when taken to the emergency room and they refused to transport him again to the hospital. The landlady then called the HRS hotline to report abuse of the elderly. The following morning, October 18, 1985, an HRS case worker was dispatched to the place where Stroganow lived. She was let in by the landlady and found an 84 year old man who was incontinent, incoherent, apparently paralyzed from the waist down, with whom she could not carry on a conversation to find out what condition he was in. She called for a Cares Unit to come and evaluate the client. An HRS Cares Unit is a two person team consisting of a social worker and nurse whose primary function is to screen clients for admission to nursing homes and adult congregate living facilities (ACLF). The nurse on the team carries no medical equipment such as a stethoscope, blood pressure cuff, or thermometer, but makes her determination on visual examination only. Upon arrival of the Cares Unit both members felt Stroganow needed to be placed where he could be attended. A review of his personal effects produced by his landlady showed his income to be over the maximum for which he could qualify for medicaid placement in a nursing home; that he was a member of IMC's Gold- Plus HMO; his social security card; and several medications, some of which had been prescribed by Dr. Dayton, a physician employed by IMC at the South Pasadena Clinic. The Cares team ruled out ACLF placement for Stroganow at the time because he was not ambulatory but felt he needed to be placed where he could be attended to and not left alone over the coming weekend. To accomplish this, they proceeded to the South Pasadena HMO clinic of IMC to lay the problem on Dr. Dayton, the Assistant Medical Director for IMC in charge of the South Pasadena Clinic. Stroganow had been a client of the South Pasadena HMO for some time and was well known at the clinic and by EMS personnel. There were two and sometimes three doctors who treated patients at this clinic and, unless the patient requested a specific doctor, he was treated by the first doctor available. Stroganow had not specifically requested he be treated by Dr. Dayton. When the Cares team met with Dr. Dayton they advised him that Stroganow had been taken to Metropolitan General Hospital Emergency Room the night before but did not advise Dayton that the EMS team had refused to transport Stroganow to the hospital emergency room a second time the previous evening. Dayton telephoned the emergency room at Metropolitan General to ascertain the medical condition of Stroganow when brought in the evening before. With the information provided by the Cares team and the hospital, Dayton concluded that Stroganow should be given a medical evaluation and the quickest way for that to occur was to call the EMS and have Stroganow taken to an emergency room for evaluation. When the Cares team arrived, Dayton was treating patients at the clinic. A doctor's office, or clinic, is not a desirable place to have an incontinent, incoherent, non- ambulatory patient brought to wait with other patients until a doctor is free to see him. Nor is the clinic equipped to do certain procedures frequently needed in diagnosing the illness and determining treatment needed for an acutely ill patient. EMS squads usually arrive within minutes of a call to 911 for emergency medical assistance and it was necessary for someone to be with Stroganow with the EMS squad arrived. Accordingly, Dayton suggested that the Cares team return to Stroganow and call 911 for assistance in obtaining a medical evaluation of Stroganow. If called from the HMO office, the EMS squad would have arrived long before the Cares team could have gotten back to Stroganow. Dr. Dayton did not have admitting privileges at any hospital in Pinellas County at this time. Upon leaving the South Pasadena HMO clinic, the Cares team returned to Stroganow. Enroute, they stopped to call a supervisor at HRS to report that the HMO had not solved their problem. The supervisor then called the Administrator at IMC to tell them that one of their Gold-Plus patients had an emergency situation. Respondent, Dr. Sanchez, called and advised that Dr. Dayton would take care of the problem. Later, around 2:00 p.m. when no ambulance had arrived, the Cares team called 911 from a telephone a block away from Stroganow's residence and arrived back just before the emergency squad. The EMS squad again refused to transport Stroganow to an emergency room and this information was passed back to Sanchez who directed that Stroganow be taken to Lake Seminole Hospital. This was the first time either Dayton or Sanchez was aware that the EMS squad had refused to transport Stroganow to an emergency room. Although Sanchez did not have admitting privileges at Lake Seminole Hospital, IMC had a contractual agreement with Lake Seminole which provided that certain staff doctors at Lake Seminole would admit patients referred to Lake Seminole by IMC. Pursuant to this contractual arrangement, Stroganow was admitted to Lake Seminole Hospital where he was treated for his injuries and evaluated for his future medical needs.
Findings Of Fact At all times pertinent to the issues herein, Respondent, Thelma L. Jones, was licensed as a Licensed Practical Nurse in Florida, holding license number PN 0704471, and Petitioner was the agency responsible for licensing nurses in Florida. On June 2, 1986, Respondent was employed as a LPN by the Glades Health Care Center in Pahokee, Florida, as nurse on the 3-11 p.m. shift. She was assigned to the West Wing of the facility, and was assisted by at least two nursing assistants. Kathy Davis, another LPN, was assigned to the East Wing of the facility with her assistants, and in that location, though not officially identified as such, was the charge nurse for the entire facility. Though licensed as a 120 bed skilled nursing home, GHCC somewhat resembles an acute care facility, since the least seriously ill patient is normally more severely affected than those in most nursing homes. The patient census at that facility at the time was between 45-60 patients, total, in both wings. The facility is a one-story building with the two parallel nursing wings separated by a corridor. While possible, it would be extremely difficult for one nurse to service both wings. At approximately 3:50 p.m., on June 2, 1986, Respondent clocked in for work at the facility, approximately 50 minutes late. She immediately went to the West Wing, where she told Ms. Davis she was quitting and delivered to her the letter of resignation she had prepared that same day. Ms. Jones then returned to her duty station and attempted to contact the Director of Nursing, Mr. Gooley by phone, but was unable to do so. She then went out on the floor and spoke with some of the patients with whom she was most friendly, telling them she was leaving, but assuring them they would be taken care of. She returned to her station and again tried to contact Mr. Gooley by phone without success. After passing out some medications and making the required entries on some medical records, and after making a count of the narcotics as required, but without making an official record of it, she went back to Ms. Davis and told her she could not reach Mr. Gooley. Ms. Jones states that Ms. Davis replied, "Don't worry about it. I'll call him." After going back to the West Wing to collect her belongings, Ms. Jones then went to the front exit, where, over the television security monitor, she again spoke to Ms. Davis, who, for the second time, allegedly said she'd call Mr. Gooley. At this point, Ms. Jones saw a wandering resident trying to run away from the facility. She caught him and turned him over to a nursing assistant and for the third time, called Ms. Davis, who advised her she had reached Mr. Gooley and he was on his way in. Ms. Davis reportedly told Ms. Jones there was no reason she should stay. According to her time clock records, Ms. Jones punched out at approximately 5:40 p.m. She contends, however, she did not leave immediately, but stayed at least an hour after punching out. Mr. Gooley, on the other hand, indicated he arrived at the facility, pursuant to Ms. Davis' call, at approximately 5:50, and though he walked through the whole facility, failed to see Ms. Jones. It is found, therefore, that Ms. Jones left prior to the arrival of Mr. Gooley. After his walk through the facility, Mr. Gooley asked Ms. Davis where Respondent was, at which point, Ms. Davis handed him Respondent's letter of resignation and the key to the narcotics cart on the East Wing. Mr. Gooley immediately went to that wing, where he counted the narcotics with Ms. Davis present. He checked other records and determined that certain medications due to be dispensed at 5:00 p.m. by the Respondent, had apparently not been dispensed. Ms. Jones strongly contends that no patient due medicines failed to receive them prior to her departure and that she noted this in at least one record in each file. She admits, however, and it is so found, that she did not complete all records necessary prior to her departure. To ensure the East Wing was properly covered after Respondent's departure, Mr. Gooley remained on duty until relieved at the 11:00 p.m. shift change. Ms. Jones asserts her departure was justified and was not without authority. She had had some previous discussion with Mr. Gooley about the proposed change in working hours to require 12 hour, 8:00 a.m. to 8:00 p.m., shifts. Since her husband went to work at 4:00 a.m. and she had two children to care for, she advised him she could not work those hours. He insisted that she do so, however. On the day before she left, when she came to work, she again spoke with Mr. Gooley about the problem and he is reported to have advised her that her family was of no importance to him and she had to work the new hours. Mr. Gooley denies this. That same day, Respondent's husband told her he was being transferred to Leesburg and she could go up there with him to work. Whether or not the aforementioned colloquy took place is immaterial. Investigation by DPR reveals Ms. Jones did not leave Clewiston right away after she left her position with GHCC, but remained in town for several days. She returned to Clewiston after staying in Leesburg for only a week or so. When hired, each employee of GHCC is given a handbook which contains the facility's policy on resignation. This policy calls for two weeks notice to be given, in the case of nurses, to the Director of Nursing. Ms. Jones failed to give two weeks notice either orally or in writing. Respondent also contends that since Ms. Davis was the nurse in charge, she had authority to release Ms. Jones when Ms. Jones decided to quit. Mr. Gooley contends, and his contention is well taken, that though the East Wing nurse held the more senior position of the two, and had authority to answer the phone, call for fire support, and perform other routine tasks, her authority did not include receiving and approving letters of resignation. Ms. Jones also contends that by notifying Ms. Davis of her intent to leave at least an hour before delivering the letter of resignation, she gave ample notice. She asserts that because the State's staffing rules were not violated by her departure, and because Ms. Davis had her own aides as well as Respondent's after she left, no harm was done by her leaving. She had previously handled the whole facility by herself with only aides, even to the extent of passing medications. When she left, though it was during a shift, she was satisfied that everything that needed to be done was done and that Ms. Davis could handle anything that came up. Mr. Gooley, on the other hand, is of the opinion that her leaving without authority; her departure without dispensing medications; and her failure to sign off on the narcotics register, itself a violation, is not consistent with the fundamental standards of proper nursing practice in Florida. Though one nurse, plus aides, may meet the State staffing requirements, in his opinion, one nurse cannot, in light of the physical layout of this facility, handle all patients in both wings. To leave only one licensed nurse in charge of the whole facility could endanger the patients. For the past two years or so, Respondent has served as the nurse in charge of the medical facility at the Palm Beach County Jail, where she has been observed on a daily basis by Lieutenant William Arthur, under whose administrative supervision she falls. He is most pleased with her work and believes that due to her efforts, the facility has received clean inspection reports since she began working there. This is unusual for jail medical facilities. He has found her to be very conscientious in her work, and an employee who anticipates problems, solving them before they grow out of hand.
The Issue Whether Petitioner is qualified to be licensed as a medical doctor in Florida by endorsement.
Findings Of Fact Petitioner Jeffrey Jad Gaier applied for licensure by endorsement in Florida by filing a written application in November of 1983 with the Board of Medical Examiners, which is within the Department of Professional Regulation. He made a personal appearance before the Foreign Graduate Committee of the Board of Medical Examiners in April 1984. After Petitioner's appearance before the Foreign Graduate Committee, the Foreign Graduate Committee made a favorable recommendation regarding Petitioner's application for licensure to the Board of Medical Examiners. However, the full Board of Medical Examiners voted to deny Petitioner's application for licensure. On May 21, 1984, the Board of Medical Examiners rendered an Order denying Petitioner's application for licensure as a physician by endorsement, stating as the grounds: Your application and supporting documentation does not provide sufficient information to demonstrate that you can practice medicine with reasonable skill and safety. See Section 458.331(3), F.S. More specifically, the clinical training you received while attending the American University of the Caribbean as disclosed within your documentation was determined to be insufficient insofar as the clinical training was not received at a hospital affiliated with a medical school approved by the Counsel [sic] on Medical Education of the American Medical Association. The denial of Petitioner's application for licensure by endorsement was taken before the Board of Medical Examiners for reconsideration on February 3, 1985. Counsel for Petitioner was present at the hearing. At that hearing, the discussion by the Board of Medical Examiners of the request for reconsideration clarified the basis for the denial of the medical license as being the overall inadequacy of the clinical training and not specifically because the clinical training was not obtained at teaching hospitals. Except for the purposes of clarifying the issue(s) herein the collegial actions of the board are irrelevant to the instant de novo proceedings. Petitioner received a B.S. degree from Clark University, Massachusetts and a Masters degree in science education from Florida Institute of Technology, August 1978. Petitioner was granted a medical degree by the American University of the Caribbean after being enrolled at that school for less than three years. During that time, Petitioner was on the campus of the American University in Montserrat, British West Indies for only eight months. There the class used prepared slides instead of gross tissue samples. Before that, Petitioner studied at the campus in Cincinnati, Ohio, where the class used rubber cadavers instead of human cadavers. All of the clinical training received by Petitioner as part of the requirements for the completion of the medical degree consisted of preceptorships at hospitals in south Florida which included Florida Medical Center, Plantation General Hospital, University Community Hospital, and Bennett Community Hospital. Dr. Neil Katz, Petitioner's principal expert medical witness, supervised Petitioner for six weeks in a preceptorship in Family Practice. Dr. Katz is a board-certified Family Physician and a fellow of the American Academy of Family Practice. He has been Chairman of the Emergency Room Department, a member of the Credentials and Qualifications Committee, and a member of the Intensive Care Unit Committee at University Hospital, Tamarac, Florida. He has taught both foreign medical students in a clinical setting and has briefly qualified as a preceptor for the University of Florida College of Medicine. Dr. Katz actually supervised Petitioner only for the six-week period at the very beginning of Petitioner's rotations. After that six-week period of time, he only "touched base" with Petitioner, seeing him on an informal basis in the cafeteria or at meetings. During the six weeks formal observation period, Petitioner accompanied Dr. Katz in his work in his office, during hospital rounds, at the emergency room, and for most other activities that Dr. Katz participated in, including committee meetings at the hospital. Petitioner took histories and did physicals on patients under direct supervision. Petitioner displayed enthusiasm and energy in his association with Dr. Katz and the rest of the program. Dr. Katz found Petitioner "barely acceptable" in three of the nine categories for which he was to evaluate Petitioner during the preceptorship. These categories were diagnostic acumen, therapeutics and management, and medical knowledge. In explaining that evaluation, Dr. Katz testified that although Petitioner was able to take a history and a physical examination, he was not able to make a diagnosis. In fact, Dr. Katz testified that Petitioner did not have truly acceptable knowledge at the time as to the various therapeutic modalities available to a physician. He encouraged Petitioner to do more reading. During his preceptorship with the University of Florida Medical School students in their first clinical semester, Dr. Katz also saw problems similar to those exhibited by Petitioner, specifically that the University of Florida students were not "super ready," so to speak, on diagnosing and doing differential diagnoses and therapeutics at that particular stage in medical school because they were still learning. I accept Dr. Katz' opinion that Petitioner had adequate exposure to the major diseases and injuries which are common to Family Medicine, sufficient for Petitioner to go into an internship, but in light of his lack of involvement with Respondent's other preceptorships in several different hospitals after the first six weeks, and in light of his specific testimony that in his professional opinion, American-trained students were far superior to the Caribbean-trained students at the same level in terms of general knowledge (TR-65-66), Dr. Katz' opinion that Petitioner did "quite good" at the end of the year and a half period is without adequate predicate and is not persuasive. Dr. Isidoro Dunn was the primary force in the arrangements for preceptorships. Dr. Dunn talked with each preceptor to work out areas which should be covered in their respective rotations. Each preceptor had a "fair amount of latitude" in deciding how to supervise the students. Petitioner was assigned by his school to do his clinical rotations in Florida. He did 14 weeks in internal medicine, 14 weeks in surgery, 10 weeks in pediatrics, 10 weeks in obstetrics/gynecology, 4 weeks in psychiatry, and 10 weeks in electives. This totals 62 weeks, not even close to two years which is the norm in medical schools in the United States. Petitioner was required to follow patients from admission to discharge in each specialty within each of these clinical rotations. Petitioner had didactic teaching on a daily basis, weekdays. Petitioner represents that he had specific didactic courses in hematology, EKG readings, pathology, orthopedics, cardiology, radiology, and gastrointestinal invasive procedures. In each subspecialty, he had a written examination after completion of the rotation, didactic teachings in each rotation, and was required to read medical journals. On Saturdays, Petitioner was required to participate in case conferences, make case presentations, and complete assigned reading from current medical journals. The case presentations necessitated review of patient records, laboratory tests, x-rays, and pathology slides. On "patient management reviews," the Petitioner was "exposed to" or "spent time in" the dialysis unit, pathology laboratory, intensive care unit, emergency room, gastrointestinal unit, blood lab, catherization department, radiology department, EKG unit, and cardiac surgery unit. Petitioner testified, and Dr. Katz confirmed, that there was an entity called the "Doctors' Club," which had a considerable amount of audiovisual equipment available for use 7 days a week, 24 hours each day. Practicing physicians used this media to obtain continuing medical education approved for credit by the American Medical Association. Petitioner represented that "on several days" he signed out equipment or reading material. There is no precise language in his testimony that he used the equipment or that he read the reading material, but drawing any other inference is straining the clear meaning of Petitioner's unrebutted testimony. Petitioner and the other students were required to use various materials from this service, but there is no evidence that Petitioner or other students were objectively checked by Dr. Dunn or their preceptors to verify that they had actually read or viewed the material assigned. Petitioner specifically testified that there was not necessarily any follow-up by the preceptors. Dr. Katz did talk with Petitioner about the reading assignments he gave. Petitioner was required to pass a competency examination for each rotation. Petitioner's clinical studies evaluation forms in his school records indicate no overall evaluation grades below "Good." Petitioner was required to attend and pass both a written and practical examination for a two-day Advanced Cardiac Life Support Course. This course is required even of board certified emergency room (ER) physicians. In Petitioner's opinion, this course was imperative for medical doctors who might work in an emergency room because they need to be very familiar with how to handle a patient presenting with a cardiac arrest, including the administration of drugs, "cardioversion" and "intubation." To the best of Petitioner's knowledge, Dr. Dunn was to report the students' progress to the dean of the American University of the Caribbean. However, the predicate for that testimony is hearsay, uncorroborated by any direct, credible evidence. As for the relationship with the university, Dr. Katz had no knowledge as to any arrangement between Dr. Dunn and the American University of the Caribbean or any counterpart-sponsoring organization in the United States. He did not know if there was any arrangement whatsoever. Dr. Katims was accepted as an expert physician witness, as an expert teaching fellow witness, and as an expert witness in medical applications and licensure. He testified that in the normal course of medical education in the United States, part of a student's medical education is clinical training, and that experience consists of bedside outpatient treatment and supervised training under the supervision of a faculty selected particularly for their knowledge, background, and interest in education and teaching. Dr. Katz testified unequivocally that a preceptorship is very different from a clinical rotation or a clerkship. A clerkship takes place in a teaching hospital, which is a very structured environment, wherein students make rounds in a very large hospital and are given instruction in an approved clinical structure. In contrast, a preceptorship gives students more knowledge about what private practice is like and it gives students a view of direct patient care, but does not replace a formal teaching setting in clinical medicine. As recognized above, in Dr. Katz' opinion, American-trained students were far superior to the Caribbean-trained students at the same level in terms of general knowledge. In Dr. Katims' opinion, Petitioner's clinical studies consisting of only four semesters were not sufficient for him to practice medicine with reasonable skill and safety. Dr. Katims testified concerning the importance of clinical training in medical education, commenting that clinical training is the sine qua non of the practice of medicine. In the usual clinical rotation, medical students are assigned to a particular area of a hospital and perform under the full-time supervision of attending physicians. In teaching hospitals, faculties are selected for their ability, interest, and dedication to education, as well as to the practice of medicine. The attending staff at a teaching hospital include house physicians, interns, and residents. Dr. Katims himself has served as a preceptor and testified that a preceptorship is one method of obtaining a minor portion of clinical training, but is very unstructured and unsupervised. Dr. Katims testified that preceptorship training is an inferior method of training because the quality of training depends totally on the quality of the physician to whom the student is assigned and the program is unstructured. There was no testimony that any of the preceptors that supervised, or purportedly supervised, Petitioner were faculty members of any medical school, let alone the American University of the Caribbean. Upon the Requests for Admissions and the Joint Pre-Trial Stipulation of the parties, it is found that: the State of Florida Board of Medical Examiners has granted a medical license to a Dr. Flugsrud-Breckenridge and a Dr. Cobb, both having non-teaching clerkships. Three doctors, Adela Fernandez, Andrew Gonzalez, and Manuel E Garcia, did their clerkships principally at the International Hospital (Miami), a non-teaching/non-medical school-associated hospital, and obtained Florida medical licenses. At least 25 foreign graduates received Florida medical licenses within the years 1981-1984 and did their clerkships principally in non-teaching/non-medical school associated hospitals. No further information appears of record by which the undersigned may determine any other similarities or dissimilarities of these licensees to each other and/or to Petitioner. Nor does the record divulge what, if any, other facts may have been considered in these cases. Petitioner is licensed to practice medicine in Georgia and is a resident of Florida. Petitioner passed the first time his Educational Commission for Foreign Medical Graduates' (ECFMG) examination was given in June, 1981. The examination is a prerequisite to acceptance in a medical residency program. The Federation of State Medical Boards of the United States, Inc.'s (FLEX) examination is recognized by all 50 states, including Florida. Petitioner took this examination after completing his rotations in Florida. Petitioner passed the June 1982 FLEX examination with an 84 percentile ranking. Fifty percent of this test is on patient management. This clinical competence examination was taken before Petitioner started his first year of residency. Petitioner had passed the FLEX examination, completed one year of residency, and obtained a medical license in another state, Georgia, by the time of the April 1984 application hearing. In Dr. Katims' opinion, Petitioner's successful passage of the FLEX examination in the 84 percentile does not show Petitioner to have had good clinical rotations, even though the FLEX test consisted of 50 percent on patient management. Dr. Katims did not feel that by the time Petitioner was in his fourth year of residency, this would be curative of deficiencies in the clinical semesters at a non-teaching hospital, but expressed the opinion that if Petitioner passes his internal medicine board examination and becomes board certified, his clinical deficiencies would be cured and Petitioner should then be granted a Florida medical license by endorsement. Dr. Katz opined that Petitioner presently possesses the medical knowledge, judgment and competency to act with reasonable skill and safety in the practice of medicine in Florida. Affidavits of Ira Spiler, M.D. and John R. Middleton, M.D. support similar opinions of these New Jersey medical physicians. Petitioner has completed three years (July 1, 1982 to June 30, 1985) of Internal Medicine residency at Raritan Bay Medical Center, Perth Amboy General Hospital, New Jersey. Petitioner is presently enrolled in a Nephrology Fellowship program, Medical College of Georgia, a teaching hospital located at, and affiliated with, the University of Georgia Medical School. Petitioner is currently eligible for board certification in internal medicine and will be certified in the event he passes the board examination taken September 10-11, 1985. Petitioner has submitted letters of Ira Spiler, M.D. and Salvatore Chiaramida, M.D., both of New Jersey attesting to Petitioner's good moral character, and no contrary evidence was turned up by the Board's investigation. The parties have stipulated that Rule 21M-22.18, Florida Administrative Code, is not applicable to Petitioner's situation.
Recommendation That the Florida Board of Medical Examiners enter a final order denying Petitioner a medical license by endorsement. DONE and ORDERED this 16th day of January, 1986, in Tallahassee Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of January, 1986.
The Issue Whether the Petitioner correctly answered questions 37, 44, 49, 83, and 206 of the General Written Exam portion of the Physician Assistant Examination administered June 25 through June 29, 1998.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health is the state agency responsible for licensing and regulating physician assistants. Sections 455.574 and 458.347(7), Florida Statutes (1997). Mr. Molina sat for the Physician Assistant Examination administered on June 25 though 29, 1998. At the hearing, he disputed the Department's determination that the answers he gave to questions 37, 44, 49, 83, and 206 are incorrect. The questions that comprise the General Written Exam portion of the June 1998 Physician Assistant Examination were objective, multiple-choice questions. The questions were drawn from a bank of questions written by licensed physician assistants trained by a psychometrician employed by the Department. Prior to being included in the question bank, these questions were reviewed and field-tested to ensure that they were good, fair questions that adequately and reliably tested the applicant's ability to practice as a physician assistant with reasonable skill and safety. After the test questions for the June 1998 examination were selected from the question bank, the questions were reviewed before the examination and after the examination. The candidates taking the examination in June 1998 were directed in the instructions to the examination to choose the best answer from among four possible answers. This instruction was included in the examination booklet provided to each candidate, and the Department's normal procedure was to read the instructions aloud prior to the examination. According to the Department, the correct answer to question 37 is "C"; Mr. Molina chose answer "B." Although question 37 is, on its face, clear and unambiguous, the reference book relied upon by the Department to support its answer, although an authoritative source for physician assistants, does not, in fact, unambiguously support the Department's answer. Question 37 refers to the "entire anterior chest," and the answer to the question can be derived from the "Rule of Nines." The "Rule of Nines" is a standard rule used in the practice of medicine and is illustrated in an authoritative text entitled Current Medical Diagnosis and Treatment, which contains a chart showing the outline of the human body divided into sections, each representing approximately nine percent of the body's surface area. The chart shows, in pertinent part, the trunk of the human body divided into the "posterior" upper trunk and the "posterior" lower trunk, with a line drawn somewhat above the umbilicus to illustrate the division of the trunk into the upper and lower portions. The Department's expert testified, without explanation, that the "entire anterior chest" is composed of both the upper and the lower trunk. This conclusion cannot be drawn from the chart contained in the reference book relied upon by the Department, and Mr. Molina's answer to question 37 is as reasonable as the answer the Department considers correct. Accordingly, Mr. Molina should receive credit for his answer to question 37. According to the Department, the correct answer to question 44 is "D"; Mr. Molina chose answer "B." Question 44 asks for the "MOST likely diagnosis" based on the facts contained in the question. Question 44 is clear and unambiguous, and the correct answer is included among the choices provided. The correct answer can be derived from information included in the reference book entitled Ophthamology for the Primary Care Physician, which is considered an authoritative text by physician assistants. Mr. Molina should not receive credit for his answer to question 44 because the answer he gave is not the correct answer. 3/ According to the Department, the correct answer to question 49 is "A"; Mr. Molina chose answer "C." Question 49 asks for the "MOST likely" diagnosis based on the facts contained in the question. Question 49 is clear and unambiguous, and the correct answer is included among the choices provided. The correct answer can be found in volume 1 of Harrison's Principles of Internal Medicine, a reference book included in the list of recommended books sent to the candidates for the Physician Assistant Examination and considered an authoritative text by physician assistants. Mr. Molina should not receive credit for his answer to question 49 because the answer he gave is not the correct answer. According to the Department, the correct answer to question 83 is "D"; Mr. Molina chose answer "C." Question 83 is clear and unambiguous, and the correct answer is included among the choices provided. The correct answer can be found in volume 1 of Harrison's Principles of Internal Medicine, a reference book included in the list of recommended books sent to the candidates for the Physician Assistant Examination and considered an authoritative text by physician assistants. Mr. Molina should not receive credit for his answer to question 83 because the answer he gave is not the correct answer. According to the Department, the correct answer to question 206 is "C"; Mr. Molina chose answer "A." Question 206 asks for the "MOST common" presentation of a precancerous lesion. Question 206 is clear and unambiguous, and the correct answer is included among the choices provided. The correct answer can be found in volume 2 of Harrison's Principles of Internal Medicine, a reference book included in the list of recommended books sent to the candidates for the Physician Assistant Examination and considered an authoritative text by physician assistants. Mr. Molina should not receive credit for his answer to question 206 because the answer he gave is not the correct answer.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding that Nigel Molina is entitled to credit for his answer to question 37 of the General Written Exam portion of the Physician Assistant Examination administered June 25 through June 29, 1998; finding that Mr. Molina is not entitled to credit for his answers to questions 44, 49, 83, and 206 of the General Written Exam portion of the Physician Assistant Examination administered June 25 through June 29, 1998; and recalculating Mr. Molina's score on the General Written Exam portion of the Physician Assistant Examination administered June 25 through June 29, 1998. DONE AND ENTERED this 8th day of February, 2000, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of February, 2000.
The Issue The central issue in this case is whether Petitioner is entitled to licensure by endorsement. Specific to the grounds for denial are the issues of whether Petitioner is of good moral character and whether he is able to practice with skill and safety.
Findings Of Fact Based upon the stipulation of the parties, the testimony of the witnesses, and the documentary evidence received at the hearing, I make the following findings of fact: The Petitioner, Norman M. Phillips, M.D., is a graduate of St. George's University School of Medicine, Grenada, West Indies, a foreign medical school. Petitioner holds a certificate from the Educational Commission on Foreign Medical Graduates (ECFMG) and has passed the ECFMG examination. Petitioner obtained a passing score on the licensing examination of the Federation of State Medical Boards of the United States, Inc. (FLEX). Petitioner is licensed to practice medicine in New Jersey. Petitioner is over 21 years of age. Petitioner has completed at least one year of an approved residency. The Petitioner has not committed any act or offense in any jurisdiction which would constitute the basis for disciplining a physician, pursuant to Section 458.331(1) or (2), Florida Statutes. Petitioner applied for licensure by endorsement as a physician in Florida. On March 26, 1988, Petitioner appeared before the Credentials Committee of the Board regarding his application for licensure. The Credentials Committee recommended to the Board that Petitioner's application be denied. The basis for this recommendation was Petitioner's alleged inability to practice medicine with reasonable skill and safety due to a mental condition and his prior performance during his medical training. The recommendation also claimed Petitioner was not of good moral character. The Board adopted the recommendation of the Credentials Committee and issued an Order stating its intent to deny the Petitioner's application. Thereafter, Petitioner timely filed for an administrative review of the denial. After graduation from medical school, Petitioner was accepted into a residency program at St. Peter's Medical Center, New Brunswick, New Jersey. This program was in internal medicine and was to cover three years of postgraduate work. After the first year, Petitioner was evaluated and offered a contract for the second year of the program. Dr. Andrew L. Hahn was the program director of the internal medicine residency program. Dr. Hahn is an expert in the matter of residency training of medical students. Dr. Hahn evaluated Petitioner's performance as satisfactory. During the second year of the residency, Petitioner received an unfavorable evaluation which placed him on notice of a need to improve in order to receive a contract for the third year of the program. Petitioner ably made necessary corrections, improved his work performance, and, consequently, received a contract for the third year. After Petitioner had received notice of his contract for the third year, he was required to perform a rotation in radiology. This rotation was selected as it was the only available course given in the time period. While Petitioner would have preferred another topic, he accepted the assignment and agreed to the rotation. The rotation consisted of approximately three weeks of classroom lectures given at a location away from Petitioner's hospital assignments. After attending a few early sessions, Petitioner determined that he had already studied the subject matter of the course in medical school and that further attendance would not benefit him. Petitioner erroneously concluded attendance was not required. Instead of attending the rotation course lectures, Petitioner remained home studying other materials, performed his hospital duties, and made applications relating to future work. Petitioner's patients did not suffer as a result of the missed classroom sessions. Petitioner attended the clinic he was assigned to during the rotation period. When Petitioner's superiors were informed of the failure to attend the classroom sessions, they approached Petitioner for a satisfactory explanation which he was unable to provide. Since they (including Dr. Hahn) considered the failure to attend a serious breach of his professional responsibility, Petitioner was given the choice of either resigning his third year placement or being terminated. Petitioner agreed to resign his third year and was given a certificate for the two years he completed. At the time of his resignation Petitioner offered to repeat the classroom work but that option was rejected by Dr. Hahn. After resigning, Petitioner told his superiors that he had worked in a pharmacy (he is a licensed pharmacist) during the time he was supposed to have been in the radiology classes. He indicated he had done this because he needed money. Petitioner had not worked in a pharmacy, however, and had fabricated the story in a lame effort to excuse his nonattendance. Subsequently, Petitioner was interviewed by Dr. Bernard Sandler for a residency program in physical medicine and rehabilitation at the Robert Wood Johnson, Jr. Rehabilitation Institute of the John F. Kennedy Medical Center in Edison, New Jersey. Petitioner was accepted into the program and fell under the supervision of Dr. Thomas Edmund Strax. Petitioner successfully completed this program in December, 1987. Petitioner did not disclose the underlying facts of his resignation from the internal medicine program to either Dr. Sandler or Dr. Strax, however, neither physician questioned him at length about it either. Petitioner did not misrepresent any pertinent history; he simply did not volunteer embarrassing information. During his residency in rehabilitation, Petitioner was observed by Drs. Sandler, Harold Arlen, and Fazal Panezai. All of these physicians found Petitioner to be able to practice medicine with skill and safety. Petitioner did not exhibit any problem related to malfeasance or incompetence. Petitioner got along with staff and worked well with others. As a resident in the rehabilitation program, Petitioner was evaluated by Dr. Strax who determined that Petitioner would require improvement in order to meet the high standards Dr. Strax maintained for his course of study. Petitioner was able to make the necessary improvements and satisfactorily met Dr. Strax's objectives. Dr. Strax is an expert in the matter of residency training of medical students. Dr. Strax had an opportunity to review Petitioner's work on numerous occasions. Dr. Strax recommended Petitioner for licensure and - found him to be qualified and competent. Petitioner is presently employed as a physician at the Veterans Administration Medical Center in Miami, Florida. Petitioner is not required to be licensed in his present employment since such position is exempt from licensure. Petitioner's present supervisor is Dr. Dorothea Glass, Chief of Rehabilitation Services. Dr. Glass interviewed Petitioner and reviewed references Petitioner had given to her. Dr. Glass knows Dr. Strax who recommended Petitioner for the position which he currently holds. While Dr. Strax advised Dr. Glass to "keep an eye on him," Dr. Glass has done as she would with all young doctors. Dr. Glass has worked with Petitioner on a daily basis since February, 1988, and believes he is competent, hardworking and honest. Petitioner is able to practice medicine with skill and safety. Petitioner is of good moral character. Petitioner did not misrepresent material information when he appeared before the credentials committee.
Recommendation Based on the foregoing, it is RECOMMENDED: That the Board of Medicine enter a final order approving the application for licensure by endorsement for the Petitioner, Norman M. Phillips, M.D. DONE and RECOMMENDED this 30th day of May, 1989, in Tallahassee, Leon County, Florida. JOYOUS D. PARRISH Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of May, 1989. APPENDIX RULINGS ON PETITIONER'S PROPOSED FINDINGS OF FACT: Paragraphs 1 through 9 are accepted. To the extent addressed in findings of fact paragraphs 11-16, paragraphs 10 through 32 are accepted. Paragraphs 33 through 36, are accepted but are irrelevant to the issues of this case. Paragraph 37 is accepted. Paragraph 38 is rejected as speculation or argument. Paragraph 39 is accepted. Paragraphs 40 through 51 are accepted. Paragraph is rejected as irrelevant. Paragraphs 53 through 63 are accepted. To the extent addressed in findings of fact paragraph 21, paragraphs 64 through 68 are accepted. Paragraphs 69 through 71 are accepted. Paragraphs 72 through 73 are rejected as immaterial, recitation, or argument. Paragraphs 74 through 76 are rejected as recitation of testimony or argument. See findings of fact paragraph 20. Paragraph 77 is rejected as argument. RULINGS ON RESPONDENT'S PROPOSED FINDINGS OF FACT: Paragraphs 1 through 10 are accepted. Paragraph 11 is rejected as irrelevant to the extent that it refers to Petitioner's performance as "marginal." Petitioner was rated satisfactory and was permitted to continue. There were areas in which he required improvement, which he was able to correct. Paragraph 12 is accepted with the clarification that the radiology rotation was selected because it was the only one available to Petitioner at the given time. That portion of paragraph 12 which relates a fourth week work in the emergency room is rejected as contrary to the weight of credible evidence. With regard to paragraph 13, that portion which states Petitioner did not attend the classroom radiology rotation is accepted, the remainder is rejected as either unsupported by the record, contrary to the weight of the evidence, or irrelevant. To the extent addressed in findings of fact paragraphs 11-16, paragraphs 14 through 16 are accepted otherwise rejected as irrelevant or contrary to the weight of the credible evidence. It should be noted that any reference to emergency work deficiencies have not been credited nor are they supported by this record. Paragraph 17 is rejected as argument. Paragraph 18 is rejected as contrary to the weight of the credible evidence or argument. Paragraph 19 is rejected as argument, irrelevant, or immaterial to the issues of this case. Paragraph 20 is rejected as argument. Paragraph 21 is rejected as unsupported by the weight of credible evidence or argument. Paragraph 22 is accepted to the extent addressed In findings of fact paragraph 17; otherwise rejected as irrelevant or contrary to the weight of credible evidence. To the extent addressed in findings of fact paragraph 19, paragraph 23 is accepted. Paragraph 24 is accepted. Paragraph 25 is rejected as recitation of testimony, argument, or irrelevant. Paragraph 26 is accepted. Paragraph 27 is rejected as unsupported by the weight of the credible evidence, irrelevant, or argument. COPIES FURNISHED: Robert S. Turk VALDES-FAULI, COBB, PETREY & BISCHOFF, P.A. Suite 3400-One Biscayne Tower Two S. Biscayne Boulevard Miami, Florida 33131 Allen R. Grossman Assistant Attorney General Department of Legal Affairs Suite 1603, The Capitol Tallahassee, Florida 32399-1050
The Issue Whether the Respondent is guilty of unprofessional conduct. Whether her license as a registered nurse, certificate no. 8829 should be suspended or revoked or whether Respondent should be put on probation.
Findings Of Fact The Respondent, Christine Richter, who holds license no. 88294-2 was employed as a registered nurse at Tallahassee Memorial Hospital, Tallahassee, Florida, during the month of February, 1977. She worked as a certified nurse and anesthetist under Ann Marie Connors, the chief nurse anesthetist. The chief nurse anesthetist reported to the Associate Executive Director April 11, 1977, that there were gross discrepancies in the narcotics record kept by the Respondent and at that time she presented him with some of the records. On April 12, 1977, Respondent was requested by the Associate Executive Director to report to his office for a conference. Nurse Connors, the chief nurse anesthetist, was also called to be present at that conference. At the conference the Associate Executive Director asked Respondent for an explanation as to the discrepancies between the narcotic and barbiturate administration record and the patient records. In reply the Respondent stated that she needed a hysterectomy and could not afford it. Upon the insistance of the Associate Executive Director that she give an explanation for the discrepancy in the hospital records, she indicated that she needed to improve her charting. She gave no explanation for discrepancies in the narcotics chart which she signed, and indicated that she would resign. The Director stated that he would accept her resignation and she left the conference. The Respondent mailed her written resignation to the Tallahassee Memorial Hospital the following day. The Accreditation Manual for Hospitals, 1976 edition, published by the Joint Commission on Accreditation of Hospitals "Anesthesia Services" pages 59 through 64 is used as the standard for anesthetic procedure. A department standard book approved by the American Hospital Association and the joint commission on the accreditation of hospitals is required to be read by each employee of the Tallahassee Memorial Hospital as it pertains to the department in which the work is to be performed. The instructions in the department standards book are the same as in the Accreditation Manual for Hospitals as far as anesthesia services is concerned. Medical records of eight patients were introduced into evidence together with Narcotic and Barbiturate Record no. 081291. This shows the date, time, patient's name, room number, doseage, attending physician and administering nurse. The doseage of drugs secured by and signed for by the Respondent, Christine Richter, was more than the records show was administered to the various patients. No accounting was made for the difference between the amounts of drugs secured and the amounts, if any, administered to the patients, although it is the duty of the nurse checking out drugs to account for its use in writing on a form provided for that purpose. The Respondent offered no verbal explanation for the missing drugs when given the opportunity to explain her actions by the Associate Executive Director at Tallahassee Memorial Hospital and her immediate supervisor, Ann Marie Connors, chief nurse anesthetist.
Recommendation Revoke the license of Christine Richter. DONE AND ENTERED this 12th day of December, 1977, in Tallahassee, Florida. DELPENE C. STRICKLAND Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1005 Blackstone Building 233 East Bay Street Jacksonville, Florida 32202 Rivers Buford, Jr., Esquire Post Office Box 647 Tallahassee, Florida 32302
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I hereby make the following Findings of Fact: Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0040343. On the morning of October 7, 198A, the Metro-Dade County Rescue Squad called the emergency room at Miami General Hospital and informed the staff that they were enroute to the hospital with a gunshot victim. Dr. Segurola, the emergency room physician, was informed of the victim's condition and immediately ordered a nurse to notify the operating room team and call a surgeon because he knew in advance that "this was going to be a serious surgical case." At approximately 7:42 a.m., the rescue squad arrived at Miami General Hospital with the victim, Samuel Kaplan. Kaplan was taken to the emergency room suffering from a gunshot wound to the abdomen inflicted by a .32 caliber bullet. When Kaplan arrived in the emergency room, his systolic blood pressure was approximately 60, he was wearing a MAST suit, he had an intravenous (IV) line going, and he was receiving oxygen. Although Kaplan was conscious and able to speak, his condition was unstable and very serious. Kaplan was initially treated by Dr. Segurola, the emergency room physician. Three nurses, a respiratory therapist and an x-ray technician were also present in the emergency room. Dr. Segurola conducted a brief physical examination of Kaplan. An entrance wound was found, but there was no exit. After the examination, a second IV line was started in the other arm and a third, central line was started in the subclavin vein. The IV lines were set at maximum or "wide open." The emergency room staff was attempting to rapidly increase Kaplan's blood volume and pressure. Kaplan's hemoglobin level was low (approximately 8 or 9), which is a sign that a patient is anemic due to loss of blood. At approximately 8:00 a.m., Respondent received a message from his telephone answering service to call Dr. Segurola at the hospital's emergency room. At approximately 8:02 a.m., the Respondent returied the telephone call and spoke with Dr. Segurola concerning the patient's condition. During the conversation, the Respondent advised Dr. Segurola to contact the operating room team and anesthesiologist to prepare for surgery. The Respondent arrived at the emergency room of Miami General Hospital in response to the call at approximately 8:12 a.m. Upon the Respondent's arrival at the emergency room, he was informed that Kaplan's blood pressure was 108/50, heart rate 106 and respiration 28. The Respondent spoke to Kaplan and Kaplan stated that he had been shot in the stomach. Respondent then proceeded to conduct a brief, but thorough, physical examination of the patient. When Respondent completed his examination, he was advised that Kaplan's blood pressure was approximately 124/50, heart rate remained at 106 and respiration remained at 28. At this point, the Respondent believed that Kaplan's condition was stabilized. Respondent advised Dr. Segurola that Kaplan should immediately be taken to the operating room for surgery. The Respondent was informed that the operating room was not quite ready and that the anesthesiologist had not arrived. While waiting for the operating room team, Respondent and Dr. Segurola reviewed x-rays of Kaplan. The emergency room nurse continued to take Kaplan's vital signs. Kaplan's blood pressure remained at 124/50. At approximately 8:20 a.m., while Respondent, Dr. Segurola and others in the emergency room were waiting for confirmation that the operating room was ready, a hospital admissions clerk walked in and informed the emergency room staff that Kaplan belonged to the Health Maintenance Organization ("HMO"). An HMO is a plan in which a patient makes pre-payment for services and is then provided medical services from a designated panel of participating physicians. The emergency room maintained two "on-call" lists, one for HMO surgeons and one for non-HMO surgeons. The Respondent was on the non-HMO list. Dr. Segurola and Respondent had a brief discussion wherein both men acknowledged that under existing hospital policy, the HMO surgeon should have been called. Thereafter, Dr. Segurola informed a nurse to telephone the on-call HMO surgeon. The HMO surgeon on call was Dr. Moises Jacobs. A secretary in the emergency room placed a call to Dr. Jacobs at approximately 8:25 a.m. Dr. Jacobs returned the phone call between 8:25 a.m. and 8:30 a.m. Dr. Jacobs spoke with Dr. Segurola. While Dr. Segurola was on the phone, Dr. Jose Selem, the anesthesiologist, arrived in the emergency room. Dr. Jacobs told Dr. Segurola to ask the Respondent to take the patient to surgery immediately and stated that he would arrive at the hospital in about 20- 30 minutes. When the Respondent was told of Dr. Jacobs' request he replied that the patient was stable and could wait for Dr. Jacobs. Dr. Selem, the anesthesiologist, also spoke with Dr. Jacobs on the telephone. Dr. Jacobs told Dr. Selem to advise Respondent that Respondent could take the patient to surgery. When Dr. Selem advised Respondent of what Dr. Jacobs has said, the Respondent replied that since Dr. Jacobs was coming to the hospital and Kaplan was an HMO patient, Respondent preferred to wait for Dr. Jacobs, the HMO surgeon. Dr. Selem then left the emergency room and went to the operating room to prepare the necessary instruments. At approximately 8:30 a.m., the Respondent advised Dr. Segurola that he was going to the hospital cafeteria for a cup of coffee and, if any changes occurred in the patient, he should be contacted. The cafeteria was located across a corridor approximately 20-25 feet from the emergency room. At the time, Kaplan was still alert and his vital signs were being constantly monitored by the nursing staff. Dr. Segurola remained in the emergency room. The operating room and all necessary personnel were ready for surgery at approximately 8:40 a.m. Sometime between 8:40 a.m. and 8:45 a.m., one of the nurses told Dr. Segurola that the Respondent's condition was deteriorating and that his blood pressure was dropping. At approximately 8:45 a.m., Kaplan's blood pressure had dropped to 80/50. Dr. Segurola told the nurse to give more blood to Kaplan (a blood transfusion had already been started). Dr. Segurola then went to the cafeteria to speak with Respondent. Dr. Segurola told Respondent that the patient's condition was deteriorating, a blood transfusion had been started, and he feared that Kaplan might die in the emergency room. The Respondent inquired as to how long it had been since Dr. Jacobs had been called and Dr. Segurola responded twenty (20) minutes. Respondent questioned whether it really had been 20 minutes. Both men looked at their watches and determined that it had been about 15 minutes since Dr. Jacobs had been called. Respondent told Dr. Segurola to call the anesthesiologist. Dr. Segurola went back to the emergency room, believing that Respondent was going to immediately follow him there. When Dr. Segurola arrived back at the emergency room, Kaplan's condition had not improved. Dr. Segurola waited about three (3) more minutes and went back to the cafeteria for the second time. Dr. Segurola again informed the Respondent about Kaplan's deteriorated condition and his fear that Kaplan was going to die in the emergency room. Respondent once more asked Dr. Segurola to call the anesthesiologist. Dr. Segurola told Respondent that the anesthesiologist was there and that "we need you there." Dr. Segurola then went back to the emergency room. The Respondent remained in the cafeteria. Shortly before 9:00 a.m., while Dr. Segurola was away from the emergency room, Dr. Lustgarten, a neurologist, had just finished his rounds and was leaving the hospital through the emergency room to the parking lot. Dr. Lustgarten looked in on Kaplan to determine if there was any neurological damage. Dr. Lustgarten examined Kaplan and concluded that there was no neurological damage and that, in his opinion, Kaplan's condition was stable with a systolic blood pressure of approximately 100. Dr. Lustgarten left the emergency room just as Dr. Jacobs arrived at approximately 9:00 a.m. Dr. Lustgarten told Dr. Jacobs that Kaplan had no neurological damage. Dr. Jacobs conducted a brief examination of Kaplan and determined that Kaplan needed to be taken to the operating room immediately for surgery. The anesthesiologist, Dr. Selem, had by then been summoned to the emergency room and assisted Dr. Jacobs in an unsuccessful attempt to intubate Kaplan prior to taking him to the operating room. Shortly after Dr. Jacobs arrived, the Respondent left the cafeteria and headed towards the emergency room. Before Respondent reached the entrance to the emergency room, he was informed by one of the nurses that Dr. Jacobs had arrived. The Respondent stood at the entrance to the emergency room for a brief period and watched as Dr. Jacobs and others attended to Kaplan. Respondent then left the building, went to his car and drove home. Meanwhile, Dr. Jacobs performed an emergency exploratory laparotomy and left thoracotomy on Kaplan. Between 9:00 am. and 9:15 a.m., after Kaplan was moved from the emergency room to the operating room, his blood pressure went from 90 down to 60, and he went into shock. There are three possible contributing factors for Kaplan's going into shock at this time: (1) moving him may have dislodged ,a blood clot which in all likelihood prevented an earlier complete "bleeding out"; (2) the blood clot may have been diluted by the IV fluid; and (3) the institution of anesthesia. During surgery it was discovered that the bullet had perforated the aorta, a major blood vessel. While still in surgery, Kaplan went into cardiac arrest and was pronounced dead at 10:25 a.m. on October 7, 1984. At the time that Respondent left the emergency room and went to the hospital cafeteria, Kaplan's vital signs were in a relatively stable condition. Kaplan's vital signs de-stabilized while Respondent was in the hospital cafeteria, and his systolic blood pressure dropped from approximately 120 to approximately 80. At all times prior to being taken to the operating room, Kaplan's vital signs were maintained with the assistance of a MAST suit. A MAST suit is an inflatable device used in the treatment of trauma patients which applies pressure to the body and assists in elevating blood pressure. When the MAST suit is removed, the patient's vital signs will deteriorate again. For this reason, many physicians consider vital signs obtained under such conditions to be false readings, and the MAST suit is usually not removed until the patient is in the operating room. Although the Respondent suspected that the bullet might have damaged the small bowels and caused some internal bleeding, the Respondent neglected to ask about the amount of fluids Kaplan had received. Kaplan had received over 4 to 5 liters of fluid prior to arriving at the hospital and received an additional 5 liters of fluid while waiting to be taken to surgery. Although this information would have been useful, it would not necessarily have indicated the extent of Kaplan's massive internal bleeding. The amount of fluids that Kaplan received prior to the Respondent leaving the emergency room was not necessarily a sign that Kaplan's condition was unstable. In the treatment of trauma cases, time is of the essence. A trauma patient with a gunshot-wound to the abdomen should be taken to surgery as soon as possible. In some cases, it may be advantageous to delay surgery in order to stabilize the patient's vital signs or to increase blood volume. Generally, if surgery is performed within the first hour after the injury is sustained (referred to as "the golden hour"), the better the chances of the patient surviving. The golden hour does not apply to injuries of the heart and major blood vessels. In those cases, the patients will "bleed out" in a time much shorter than one hour. Nevertheless, even where the golden hour has passed, the patient should be taken to surgery at the first available opportunity and without delay. While in the emergency room at Miami General Hospital, Kaplan's condition ranged from "serious" to "critical." From the time that Kaplan was initially admitted to Miami General Hospital his condition was such that he required immediate surgical intervention. A reasonably prudent physician in the Respondent's position would have performed surgery at the first available opportunity and would not have waited for the arrival of another surgeon. Although pursuant to hospital and HMO rules, the HMO surgeon should have been called first, where an emergency situation exists the first surgeon available is expected to take the patient to surgery, and that physician will be provided payment by the HMO. The Respondent was aware of the hospital's and HMO's policies regarding HMO and non-HMO patients based on prior experience. The Respondent has never previously been disciplined or investigated by Petitioner or any medical board in any jurisdiction. Respondent maintains an excellent reputation for competence and compassion among his fellow physicians. Respondent is well liked by his patients and has provided medical services in the past to patients with no medical insurance.
Findings Of Fact Respondent B. Delores Lane Eckard holds a Florida license as a registered nurse, No. 1091372. She has been so licensed since September 10, 1979. Petitioner's Exhibit No. 1. Before she was fired in July of 1983, respondent worked twelve-hour night shifts in the surgical intensive nursing unit at Baptist Hospital in Pensacola. A burn victim, Marc MacInvale, was among the patients respondent attended, during the shift that began at seven o'clock on the evening of June 15, 1983. Because of the extent of his burns, Mr. MacInvale had been placed in a private room, and hospital staff observed "reverse isolation" techniques. In or on his nightstand, Ms. Eckard found two, ten milligram ampules of Valium. Knowing that it was against hospital policy for the ampules to be there, she picked them up, intending to return them to the medication cart. She put them in her pocket for safekeeping, while she finished tasks in Mr. MacInvale's room. After she got home from work, on the morning of June 16, 1983, she undressed and went to bed. When she awoke and gathered up her clothes for washing, she discovered that the ampules were still in the pocket of her uniform. She was aware that a nurse had been fired two weeks earlier when Valium had been discovered in her locker at Baptist Hospital; and she decided against notifying the hospital or anybody she worked with of the whereabouts of the Valium. Instead, she placed the ampules in a clear plastic bag together with a piece of paper with Marc MacInvale's name on it and put the clear plastic bag in her "work purse," with the intention of returning the Valium to the hospital, when she next went to the hospital. In these circumstances, failure to report promptly that she had removed a patient's medicine from his room and that he did not receive it fell below minimal standards of acceptable and prevailing nursing practice, according to uncontroverted testimony. The clear plastic bag with the ampules and the piece of paper with "Marc MacInvale" written on it were still in Ms. Eckard's purse when she was arrested in the early morning hours of June 17, 1983, for driving under the influence of intoxicants. Celebrating with friends at a restaurant in anticipation of her June 18 birthday, she had drunk two glasses of wine and a "brandy manhattan," but had ingested no other intoxicating substances, before setting out for home. After her arrest, she demonstrated poor coordination and balance, slurred speech and difficulty in understanding. After twice registering less, the breathalyzer registered 1.0. Formal charges were apparently filed, and, on October 19, 1983, respondent pleaded nolo contendere. Petitioner's Exhibit No. 2. The police examined the contents of respondent's purse on June 17, 1983, and an assistant state's attorney eventually inquired of William Allen Foster, Baptist Hospital's director of security, whether Valium had been prescribed for Marc MacInvale. Norma Jean Vaughan, respondent's supervisor, confronted her, after she learned that Ms. Eckard had been arrested with Valium in her purse. Respondent volunteered blood and urine samples for analysis. The results of analysis were negative, but Baptist Hospital terminated her employment nevertheless. At the time, things were not going well on the domestic front, either. Ms. Eckard's husband had beaten her, and they were separated. In despair, she recorded the following: "Begin a good-bye tape. Um, I don't want anybody feeling sorry for me. I just want everyone to know why - I never thought that I would come to this point in my life. Cir- cumstances have, uh, made it so that I have, and the decision has been made and is irrevocable. In my forty-three years, I've spent the first (voice shaky, clearing throat) well, five years, with a divorced mother. Then, I spent until I was eleven in an orphanage. This taught me a lot of compassion, if, nothing more. Through my teen years, I had various stepfathers; many were - had means and, uh, were very good to me. I married young and was very happy - raised three chil, well, two children, and, uh, thought I did a decent job. Thought our marriage was well organized and pretty happy, overall. We had everything under control. We saved our money. We made good investments. Everything was going our way. I decided after the children were grown that I wanted to be a nurse. I could do what I wanted to do now. My job with the children was over as far as their, their primary needs were concerned. They had other interests in their lives, and I accepted my displacement. I went to nursing school and, uh, worked very hard to make the grades that I did. I went far and beyond what I had to do to advance my knowledge in medicine and to prepare myself to be the best nurse that I could be. I've worked five years in nursing and, uh, even though I worked Surgical Floor, many people feel like all you do is change bandages, do your job and that's it. The emotional needs of the patient are completely ignored. They hurt, you give them pain meds or you tell them, 'That's too bad; you can't have any pain medicine for another so many hours. And then, that's it. There's no, there's no, uh, efforts to make them more comfortable during that waiting period where they, where they're suffering so much. Or maybe they feel that nobody loves them. Nobody cares. They feel the isolation (pause) the, like no one's with them. They're in an alien environment. A lot of this is ignored by a lot of nurses. I was in reverse isolation when I was burned, and I spent three months in a wheelchair. I know what it is to be alone in an isolation room and, uh, the nurses saying, 'Oh, my God, do I have to dress that again?'. You know. Nobody, it's not a very pleasant thing, but I know the feeling of isolation. I know the feeling of not feeling wanted even though you are. Uh, and I've tried to take, in my nursing, the total body into, to mind to try to fill the needs of the total person, not just the colostomy. It's not a colostomy patient. It's not, it's not a cardiac, and uh, and uh, an abdominal mass, a tumor or whatever. It's a person to me. The compassion that my patients and the families feel that I've afforded has been given freely because I do care about that person as a human being. I have found though (choked up - brief pause - then voice somewhat shaky), now that my life has essentially fallen apart. The marriage that I thought would last forever, you know. Now, we're in our middle years and the kids are grown and we're making good money and we can afford nice things, uh, we can have a nice bank account. We can go places and do things, but then you find that this doesn't happen - that somewhere along the, that time of getting there, that you've lost what originally drew you together. Those dreams of making it there. You've made it. Where is there to go? (Big sigh.) I guess, and with my husband's illness, he can't help, I guess, what he said to me. I never thought anyone would want to hurt me. I've been fairly well protected all my life. I'm not a worldly person as far as the streets are concerned or, or what goes on in this world. I'm well versed in politics and, and in things like that, but my world consists of my work and my home. Now, I come home to an empty house, and I have no goal as far as nursing is concerned. That's been taken away from me also. So - and I feel sort of deserted because, with the exceptions that I've made for other people and for the hospital, things that, things that I would like to change that, that bother me have never been changed and never will be. Those are accepted. Uh, doctors that harm my patients - that has had to be accepted - reported and nothing really accomplished by it. That person is still there. (Click. Recorder apparently turned off and then back on. Clearing throat and then continuing in a somewhat deeper tone of voice.) Yet, when I, as a nurse, inadvertently make an error without malice or without forethought, and with every intention of correcting my error, my only thought was protecting my job - a job that I love dearly, that I was afraid of losing. This was the only reason it wasn't reported to you by myself. Then, I am terminated. And the only other reason for my existence is taken away from me. This is not to make you feel guilty. I know you have your job to do. I know there have been exceptions made. I know of one girl in particular where her whole life was a damn exception, and she has actually come close to killing patients, and it could be proven by records, etc. by actual observations. And yet, she's welcomed with open arms when she comes back. She left in a world of glory. It's as one of our other nurses said, 'She could fall in a bucket of (pause) and come up smelling like a rose very time.' My assets are frozen now. I have no means of support other than my job. I have no other place I want to go or would go. I've thought it over, and I know where my place in life lies and I know what my future holds. It holds nothing at this point because I can't make that decision to divorce my husband or to have him come back here. Those are my options at this point for survival. Those decisions I cannot make. The decision to work - the only reason I had any medication at all was the fact that I had been beaten half to death, and I was forced to go to Dr. - to the doctor simply as a, because I needed the slip to come back to work. At that point, he saw that I was just falling apart as far as my nerves were concerned, simply because my system couldn't adjust to the beatings that I had, had been inflicted upon me. He suggested that I take something until I got over that hump. I've never taken medication before, and, uh, as I told you, I told him I didn't want anything heavy because my system was just not used to medication and anything that I took, even an aspirin, one aspirin, would cure a headache. So, uh, my system is super sensitive to medication apparently. Therefore, he prescribed what he did and, uh, I took it. It's the lowest dosage he could have give - that he could give me. Uh, he said I could take up to 30 milligrams without any harm. The maximum I took was 10, and this was only, you know, when I was really upset and, or felt that I was not in control. For instance, like when I had to meet with my husband or things like this due to the legal matters, or uh, other business interests that we had that brought us together. I'm not making this tape to defend myself. I don't think any defense really is necessary because I've done nothing really wrong. I made an error in judgement, and I've paid dearly, both financially, emotionally, etc...I've lost everything for one error in judgement. I would hope that this would never happen to anyone else because it leaves you with very few options in your life. So, I appreciate your support as far as your confidence in my nursing care. (Click. Recorder apparently turned off and then back on.) I appreciate the fact that you didn't take my license away. I guess that would have been the ultimate defeat. Um (pause) at this point, as I said, um, I have no options. I feel that you're put on this earth for a purpose. My purpose has ended." She mailed the tape recording to Baptist Hospital where various people listened to it on July 8, 1983. Mr. Foster tried to reach respondent by telephone, but got a busy signal. He then called the police department. Three policemen appeared at her home to find her talking to a friend on the telephone. At least one of the policemen stayed to talk for an hour or two, then left and called Mr. Foster. He told Mr. Foster he did not think that Ms. Eckard "needed to be Baker Acted," but said that he would look in on her again later in the day. On December 4, 1983, Ms. Eckard was arrested a second time for allegedly driving under the influence of alcohol, but the state's attorney's office did not pursue these charges. The arresting officer testified at the hearing in the present case. Neither his testimony that she was driving nor his testimony that she was intoxicated has been credited.
The Issue The issue in this case is whether the challenged portions of the proposed amendments set forth in the Fourth Notice of Change for Rule 64B8-9.009, Florida Administrative Code (FAC), published in the Florida Administrative Weekly on February 18, 2000, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Background Rule 64B8-9.009, Florida Administrative Code, is the Board's Rule governing the standards of care for office surgery. The Rule was first adopted on February 1, 1994 as a Rule 61F6- 27.009, Florida Administrative Code. It was transferred to Rule 59R-0.009, Florida Administrative Code, and was amended on May 17, 1994; September 8, 1994; and November 15, 1994, and then was finally transferred to Rule 64B8-9.009, Florida Administrative Code. In February of 1998, the Board directed its Surgical Care Committee to evaluate Rule 64B8-9.009 and to make recommendations for any modifications or amendments to the Rule. The 1998 Florida Legislature also addressed the issue of office- based surgery and provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings . . . " including office-surgery environments. As discussed below, hearings were conducted by the Board and its Surgical Care Committee to consider changes to the office surgery rule. The Parties R. Gregory Smith, M.D., Charles Graper, D.D.S., M.D. and Florida Academy of Cosmetic Surgery Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Smith practices cosmetic surgery, plastic surgery, and oralmaxillofacial surgery in his office. Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery and a degree in medicine. Approximately 30 percent of FACS members use general anesthesia (Level III) in their office surgery procedures. At least one representative of FACS has attended each public rulemaking hearing relating to proposed Rule 64B8-9.009, Florida Administrative Code. FACS actively participated in the rulemaking process, expressing concerns relating to transfer agreements, hospital privileges, and the requirement for an anesthesiologist in Level III surgery. FACS' purposes include addressing adverse outcomes in the field of cosmetic surgery and implementing recommended approaches to improve patient safety. Petitioner Charles E. Graper, D.D.S., M.D., is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Graper received his doctorate in dental surgery from Emory University in 1971, his medical degree from Hahnemann University Medical School in 1983, and received one year of post-graduate training in general surgery at Orlando Regional Medical Center. Graper is Board-certified by the American Board of Oral and Maxillofacial Surgery, Board- certified in general cosmetic surgery, Board-eligible in general plastic surgery, and is a Fellow of the American College of Surgeons. Graper performs in his office cosmetic surgery, functional surgery, and surgery below the head and neck which would not be authorized by his dental license. Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. Graper has experience in performing Level III office surgery using general anesthesia. The Board of Medicine The Board of Medicine (Board) regulates the practice of medicine in Florida, and is the agency that adopted the rule at issue. The Florida Society of Plastic Surgeons, Inc., Florida Chapter, American College of Surgeons and Florida Society of Dermatologists The FSPS, FCACS, and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. As licensed physicians (M.D.s), members of FSPS, FCACS, and FDS are subject to the regulations promulgated by the Board of Medicine. A substantial number of physician members of the FSPS, the FCACS, and the FSD perform office surgery and are affected by the proposed amendments to Rule 64B8-9.009, Florida Administrative Code. FSPS is a Florida not-for-profit corporation whose 270 members are board-certified plastic surgeons (of the approximately 375 such physicians statewide) licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSPS was created and exists for the purposes of promoting plastic surgery as a science and profession. FSPS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members, and has participated throughout the rulemaking process with respect to Florida Administrative Code Rule 64B8-9.009. FCACS is a Florida not-for-profit corporation whose 1400 members are surgeons licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FCACS was created and exists for the purposes of promoting surgery as a science and profession. FCACS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including Petitioner Graper, routinely perform office surgery. FSD is a Florida not-for-profit corporation whose 462 members are board-certified dermatologists licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSD was created and exists for the purposes of promoting surgery as a science and profession. FSD regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including David Allyn, M.D., and Diane Calderone, M.D., routinely perform office surgery. The Florida Society of Anesthesiologists, Inc., Florida Hospital Association, Inc. and Association of Community Hospitals and Health systems The FSA is a not-for-profit professional membership organization representing approximately 2,000 anesthesiologists in Florida. FSA members practice in educational institutions, hospitals, ambulatory surgical centers, and physicians' offices. The purpose of the FSA is to provide its members information about anesthesiology and to inform the public about issues related to anesthesiology. The FHA and the ACHHS are nonprofit trade associations which represent over 200 hospitals and health systems. FHA and ACHHS represent member hospitals and health systems on common interests before the branches of government, particularly with respect to regulations that impact the members. The Florida Nurses Association (FNA) The Florida Nurses Association is a professional association of approximately 7,500 nurses licensed in the state of Florida, including approximately 1,700 advanced registered nurse practitioner (ARNP) members and a substantial number of CRNAs. Among its many purposes, the FNA represents the legal, legislative, and professional practice interests of the members. The Florida Association of Nurse Anesthetists Petitioner, Florida Association of Nurse Anesthetists (FANA), is a non-profit corporation and professional organization made up of more than 1,600 certified registered nurse anesthetists practicing throughout Florida, many of whom currently provide anesthesia for surgery performed in physicians' offices. As a part of its mission, FANA advocates its members' interests in legal, legislative, and professional practice issues. Rule Challenges by FSA and the Hospitals On July 8, 1999, the FSA filed a Petition for Administrative Determination of Invalidity of Proposed Rule challenging portions of the proposed amendments to Rule 64B- 8.9009 as set forth in the Second Notice of Change. The FSA's Rule challenge was assigned DOAH Case No. 99-2974RP. Also on July 8, 1999, the Hospitals filed a petition for Administrative Determination of the Invalidity of Proposed Rules challenging portions of the proposed amendments to Rule 64B8-9.009 as set forth in the Second Notice of Change. The Hospitals' Rule challenge was assigned DOAH Case No. 99-2975RP. The Board conducted a third public hearing on the proposed Rule amendments on August 7, 1999. The Board published a Third Notice of Change to the proposed Rule amendments in the August 20, 1999, issue of the Florida Administrative Weekly. None of the changes in the Third Notice of Change related to provisions that were in litigation. On January 12, 2000, the Board, the FSA, and the FSPS filed a Joint Stipulation on provisions of Rule 64B8-9.009, Florida Administrative Code (Joint Stipulation) in DOAH Case No. 99-2974RP. The Joint Stipulation released from FSA's Rule challenge, Case No. 99-2974RP, the majority of the proposed amendments to Rule 64B8-9.009 and reserved only the proposed amendments to Subsections (1)(e) and (6)(b)1.a. of Rule 64B8- 9.009 for challenge. On January 26, 2000, the Hospitals filed a Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(b)1. and 2. and (6)(b)1.a. and b. In light of the filing of the Joint Stipulation in DOAH Case No. 99-2974RP, and the filing of the Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, the proposed amendments to Rule 64B8-9.009 were no longer subject to challenge, with the exception of the proposed changes to Subsections (1)(e), (2)(e), (2)(f), (2)(I), (4)(b)1., (4)(b)2., (6)(b)1.a. and (6)(b)1.b. Accordingly, on January 28, 2000, the Board filed the proposed amendments to Rule 64B8-9.009 that were no longer subject to challenge with the Department of State for Adoption. The Board subsequently conducted an additional public meeting and published a fourth notice of change relating to the proposed amendments to Rule 64B8-9.009 still subject to challenge by the FSA and the Hospitals. These changes included the withdrawal of the proposed amendments to Subsection (4)(b)1. which would have changed "transfer agreement" to "transfer protocol." During this public meeting, the Board was informed that those parts of the Rule no longer being challenged had been filed with the Department of State. On January 28, 2000, the Board filed all of its proposed amendments to Rule 64B8-0.009, with the exception of the amendments to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)1. and 2., and (6)(b)1.a-b, for adoption with the Florida Secretary of State. The proposed amendments filed for adoption on January 28, 2000, became effective February 17, 2000. The Board voted to modify some of the proposed amendments to Rule 64B8-9.009 still subject to challenge at its public meeting on February 5, 2000. The FSA filed a Notice of Voluntary Dismissal of its Rule challenge in DOAH Case No. 99-2974RP on February 7, 2000. DOAH case No. 99-2974RP was closed on February 8, 2000. The Hospitals filed a Notice of Voluntary Dismissal of their Rule challenge in DOAH Case No. 99-2975RP on March 9, 2000, and the case was closed on March 10, 2000. The Fourth Notice of Change was published in the February 18, 2000, issue of the Florida Administrative Weekly noticing the changes to proposed amendments to Rule 64B8-9.009 voted on by the Board at its February 5, 2000, meeting. On February 25, 2000, the FACS, Graper, and Smith filed a Petition for an Administrative Determination of the Invalidity of a Proposed Rule challenging the Board's proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. This petition was assigned DOAH Case No. 00-0951RP. On March 8, 2000, the FACS, Graper, and Smith filed an Amended Petition for an Administrative Determination of the Invalidity of a Proposed Rule in DOAH Case No. 00-0951RP challenging the Board's proposed withdrawal of the proposed changes to Subsection (4)(b)1. of Rule 64B8-9.009 and the proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. The Board held a public hearing on April 8, 2000, in Orlando, Florida, and received testimony concerning the Fourth Notice of Change. At the conclusion of the hearing, the Board voted to adjourn without making any changes in the Fourth Notice of Change. On April 17, 2000, the FANA filed its petition challenging the Board's Fourth Notice of Change. The FANA's petition was assigned DOAH Case No. 00-1622RP. DOAH Case Nos. 00-0951RP and 00-1622RP were consolidated by Order of the Administrative Law Judge issued May 4, 2000. The Fourth Notice of Change states that "[t]he proposed changes to Subsection (4)(b)1., shall be withdrawn." With respect to Subsection (6)(b)1.a. of Rule 64B8- 9.009, the Fourth Notice of Change states: Proposed Subsection (6)(b)1.a. shall be changed to read, (b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: Training Required. a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia. If the anesthesia provider is not an anesthesiologist, there must be a licensed M.D., or D.O., anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia. Petitioners have challenged the Fourth Notice of Change on the following grounds: (1) the requirement that an anesthesiologist be present for all Level III surgeries in physicians' offices will increase the cost and limit surgical procedures and practice opportunities of Petitioners resulting in a substantial adverse financial impact on Petitioners and patients; (2) the Fourth Notice of Change exceeds the Board of Medicine's rulemaking authority by attempting to regulate nurse anesthetists; (3) the Fourth Notice of Change conflicts with existing statutes governing the practice of nurse anesthetists; (4) the rule is arbitrary and capricious and is not supported by competent evidence and is inconsistent with the law and policies of the federal government and of 49 states; (5) the Fourth Notice of Change is not supported by competent substantial evidence and would not have any measurable effect on patient safety; (6) the Rule was improperly adopted; and (7) that the Fourth Notice of Change conflicted with the existing requirement to provide a choice of anesthesia providers. Each of these arguments is addressed below. Final Order in DOAH Case No. 00-1058RX The Final Order in DOAH Case No. 00-1058RX invalidated certain existing Rule requirements related to transfer agreements and hospital staff privileges as a precondition for certain office surgeries. Specifically, that Final Order invalidated Subsection (4)(b) of Rule 64B8-9.009, which required a transfer agreement for any physician performing Level II office surgery who did not have staff privileges to perform the same procedure at a licensed hospital. In addition, the Final Order invalidated Subsection (6)(b) of Rule 64B8-9.009 which required a physician performing Level III office surgery to have hospital staff privileges for the procedure performed in an out-patient setting. As grounds for invalidating the staff privileges requirement, the Administrative Law Judge determined that the Board lacked specific statutory authority to mandate hospital privileges, thereby exceeding its grant of rulemaking authority. The Final Order further determined that the requirement for hospital privileges was arbitrary, deferred credentialing to individual hospitals, and was not supported by competent substantial evidence. During the prior hearing, the parties did not present specific argument related to, nor did the Final Order consider the proposed changes to the staff privileges requirement set forth in the Fourth Notice of Change due to the separate Rule challenge proceedings. The Proposed Rule Regarding Competency Demonstration Notwithstanding, Subsection 4 of the Fourth Notice of Change proposes to change Subsection (6)(b)1.a. of Rule 64B8- 9.009 to include alternatives to hospital staff privileges as a manner of demonstrating sufficient education, training and competency to perform Level III surgery in an office setting. The proposed change provides that a surgeon who seeks to provide Level III surgery in an office setting can demonstrate training as follows: The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other Board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training, and experience. (emphasis added) The proposed Rule at issue in this proceeding continues to provide for the same mechanism of hospital privileges, previously invalidated. The provision remains invalid for the reasons articulated in the previous Final Order. However, the proposed Rule also provides office surgeons with two alternative methods for objectively demonstrating sufficient training and competency through certification by a recognized medical specialty board or through direct demonstration to the Board of Medicine. That provision of the proposed Rule, provides significant flexibility and meaningful options to physicians seeking to perform office surgery. The Board demonstrated that the options are an appropriate approach for the Board to utilize in exercising its delegated regulatory authority and responsibility to adopt education and training standards for the office setting. The Petitioners adequately challenged the provisions and the Board proved the validity of the proposed alternatives by a preponderance of the evidence. Increased Costs Petitioners contend that the anesthesiologist requirement in the Fourth Notice of Change violates Section 120.52(8)(g), Florida Statutes, by imposing regulatory costs on the regulated person which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives. Petitioners offered credible evidence indicating that the hourly rates charged by anesthesiologists range from 50 to 100 percent higher than the hourly rates charged by CRNAs for similar procedures. Respondent and Intervenor, FSA, on the other hand, demonstrated that hourly rates varied from market to market within Florida and in a few cases, rates for anesthesiologists were approximately the same as for CRNAs. The evidence is clear, however, that the charges for an anesthesiologist are significantly higher than those for CRNAs for similar procedures. Anesthesiologists possess broader expertise, education, and training. As a result, requiring an anesthesiologist for Level III office surgeries will increase the total cost of a typical in-office plastic or cosmetic surgery procedure between five and ten percent. Furthermore, the evidence demonstrated that although some surgeons periodically use anesthesiologists during Level III office surgery for a variety of reasons, including availability, complexity of procedure, current health of patient and contractual agreements, most surgeons utilize CRNAs due to the considerable cost savings. Petitioners also claimed that the Rule would create a monopoly in the provision of in-office anesthesia for anesthesiologists and would force hundreds of CRNAs out of office practice. The Fourth Notice of Change applies to Level III surgeries, so it is reasonable to conclude that the need for CRNAs to participate in the performance of Level III surgeries under the supervision of an anesthesiologist will be obviated. Their assistance is unnecessary and cost prohibitive. And although nurse anesthetists would still be permitted to provide Level II anesthesia in the office setting under the supervision of the operating surgeon, the proposed Rule imposes a significant increase in the cost of Level III surgeries and severely decreases competition. Rulemaking Authority and Conflicting Law Petitioners mistakenly contend that the proposed anesthesiologists requirement exceeds the scope of the Board of Medicine's rulemaking authority and conflicts with existing law. The authority for the Fourth Notice of Change is contained in part in Section 458.33(1)(v), Florida Statutes, which states in pertinent part: The Board may establish by rule standards of practice and standards of care for particular practice settings, including but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manual in order to establish grounds for disciplining doctors. Specifically, Petitioners allege that the Fourth Notice of Change constitutes an impermissible attempt by the Board of Medicine to regulate nurse anesthetists and conflicts with Chapter 464, Florida Statutes, which permits nurse anesthetists to practice under the supervision of any physician, osteopath, or dentist. The parties have stipulated that Florida-certified registered nurse anesthetists are licensed only by the Florida Board of Nursing and are subject to discipline only by the Florida Board of Nursing. In mandating that office surgeons use an anesthesiologist during in-office Level III surgery, the proposed Rule does not directly regulate any nurse or certified registered nurse anesthetist and does not subject the CRNA to any discipline by the Board of Medicine or by the Board of Nursing. Thus, the Rule on its face does not conflict with the delegated legislative authority to the Board of Medicine for rulemaking in Section 458.331(1)(v). Federal Law, Scientific Evidence, Arbitrary and Capricious, Competent Substantial Evidence Petitioners contend that the Fourth Notice of Change requiring an anesthesiologist be present during Level III surgery is inconsistent with the laws and policies of the federal government and 49 states, contrary to the overwhelming weight of scientific evidence, arbitrary and capricious, and not supported by competent substantial evidence. There is no evidence that the Fourth Notice of Change is inconsistent with the laws and policies of the federal government. There is no federal law or rule which prohibits any state from establishing its own rules governing the rights of various practitioners to administer or supervise the administration of anesthesia in any particular setting. Federal government regulations defer to state law on this subject unless a state establishes a lower standard of care. While it is insignificant whether any other state currently requires an anesthesiologist to be present for the administration or supervision of general anesthesia in an office setting, some states have considered such requirements, including Pennsylvania and New Jersey. With respect to the scientific evidence presented by the parties, it is clear that there is a lack of competent and substantial evidence to demonstrate an increased level of safety for general anesthesia patients who undergo surgery under the care of an anesthesiologist as opposed to a CRNA. CRNAs are advanced registered nurse practitioners. In addition to their nursing training, CRNAs must have at least one year of experience in a critical care setting (such as working in a hospital intensive care unit) prior to beginning their two- to-three year master's level anesthesia training. Nurse anesthetists typically are trained side by side with physician anesthesia residents, use the same textbooks, and are taught by the same instructors. Unlike physician anesthesiologists who receive a general medical-surgical license that may not require any level of training or expertise in the administration of anesthesia, CRNAs must pass a national certifying examination in anesthesia as a condition of state licensure. In addition, CRNAs must complete 40 hours of continuing anesthesia education every two years, and must be recertified every two years to retain their state license. The evidence suggests that the safety of office surgery is comparable to that of hospitals and ambulatory surgery centers. Moreover, under the existing Rule, the office surgeon and patient determine the most appropriate anesthesia provider and setting based on the individual patient's needs. The direct testimony and scientific evidence indicate no significant difference in patient outcomes based on whether anesthesia is administered by an anesthesiologist or CRNA. Hence, Florida law and the existing standard of care in Florida permits a surgeon to supervise a CRNA in the office setting. Nearly forty percent of the 1600 CRNA members of FANA provide anesthesia in physicians' offices. Furthermore, the evidence indicates that anesthesiologist supervision of CRNAs in hospitals is extremely inconsistent. "Supervision" as defined by various hospitals requires the anesthesiologists to be within five to thirty minutes of the hospital. Anesthesiologists are often absent for extended periods and typically "supervise" several operating rooms simultaneously. In fact, Federal Medicare regulations permit an anesthesiologist to receive payment for the "medical direction" of as many as four CRNAs at the same time. Moreover, several smaller and often rural hospitals and ambulatory surgical centers in Florida do not have anesthesiologists on staff. CRNAs provide the anesthesia services in those venues. Dr. David Mackey, an anesthesiologist, testified that he had reviewed information on 28 deaths related to office surgery which occurred between 1987 and 1999. Dr. Mackey concluded that there have been nine deaths resulting from office surgery in the past 12 years in which anesthesia was a cause of death. However, Dr. Mackey was able to confirm that a CRNA provided the anesthesia in only two of the nine cases. Office surgeons and related professional societies agree that an office-based surgeon may safely supervise a CRNA. Currently, there are three national accrediting organizations that may accredit office surgery facilities: Joint Commission on Accreditation for Ambulatory Healthcare Organizations; American Association for Accreditation of Ambulatory Surgery Facilities; and Accreditation Association for Ambulatory Health Care. Rule 64B8-9.0091, Florida Administrative Code. None of these accrediting organizations requires that CRNAs be supervised by an anesthesiologist. No other state currently requires anesthesiologist supervision of CRNAs in an office setting. In fact, Florida's Joint Committee of the Boards of Nursing and Medicine identify specific medical acts that may be performed by ARNPs, and the level of physician supervision required for such acts. Section 464.003(a)(c), Florida Statutes. The Joint Committee does not require anesthesiologist supervision of CRNAs in any setting. The U.S. Armed Forces do not require anesthesiologist supervision of CRNAs in any practice setting. And the American Society of Anesthesiologists' has published its own "Recommended Scope of Practice for Nurse Anesthetists" which provides for CRNAs to administer anesthesia under the supervision of the operating surgeon. Studies of Anesthesia Outcomes and Medical Error Michael B. Pine, M.D., a Board-certified cardiologist, former chief of cardiology at Cincinnati Medical school, and a former professor of medicine at Harvard Medical School and two other medical schools, testified as an expert in healthcare quality assessment and improvement. Dr. Pine has served as a healthcare quality assessment and improvement consultant to the JCAHO, the Health Care Financing Administration (HCFA), the American Medical Association (AMA), the American Osteopathic Association, the Hospital Research and Educational Trust of the American Hospital Association, the American Association of Oral and Maxillofacial Surgeons, the American Association of Nurse Anesthetists, Blue Cross/Blue Shield, and Anthem, among others. Dr. Pine characterized his career transition from clinician to consultant as moving from "dealing with diseased individuals to dealing with diseased organizations to help them assess their problems in delivering health care and help them improve and get better." Dr. Pine assisted in the development of clinical indicators for JCAHO, including indicators in anesthesia care. He has worked with the federal Health Care Financing Administration (HCFA) to measure hospital mortality and adjust for patient severity as an indicator of hospital quality. Dr. Pine's consulting experience includes evaluating outcome data for individual practitioners, groups of providers, and whole systems. Dr. Pine testified that the classic study in anesthesia mortality was a 1950's study by Beecher and Todd of 600,000 anesthetic administrations which were followed by about 8,000 deaths, 325 of which were ultimately determined to be anesthetic related. The study reflects an anesthesia mortality rate of about 1:2,500. In the Beecher and Todd study, nurse anesthetists performed twice as many cases as anesthesiologists, but the number of deaths involving nurse anesthetists was virtually the same as the number of deaths involving anesthesiologists. Beecher and Todd initially hypothesized that the greater mortality rate for anesthesiologists could be explained by the severity of illness of the patients seen by anesthesiologists rather than nurse anesthetists, but after correcting for the difference in severity of illness, they discovered the nurse anesthetists had actually treated patients who were slightly more sick. Beecher and Todd were unable to explain why physician anesthesiologists, who anesthetized only half as many patients as nurse anesthetists, were involved in an equal number of deaths. Dr. Pine testified that a later study, the Bechtoldt, measured outcomes associated with two million anesthetics in North Carolina between 1969 and 1976. The mortality rate was approximately 1:24,000; a mortality rate ten times better than the rate reflected in the Beecher and Todd study 20 years earlier. The Bechtoldt study compared the outcomes of anesthesiologists working alone, nurse anesthetists working alone, and CRNAs and anesthesiologists working together, the surgeon or dentist administering anesthesia him/herself, and deaths in which no provider could be identified. Bechtoldt concluded that: When we calculated the incidence of anesthetic related deaths for each group which administered the anesthetic, we found that the incidence among the three major groups - the CRNA, the anesthesiologist, and the combination of both - to be rather similar. Although the CRNA working alone accounted for about half the anesthesia- related deaths, the CRNA working alone also accounted for about half the anesthetics administered. A 1980 study by Forrest of 17 hospitals and about 10,0000 patents was one of the first studies to make a formal adjustment for the sickness severity of the patients. Using conservative statistical methods, Forrest concluded that "there were no significant differences in outcomes" between the hospitals that predominately used anesthesiologists and the hospitals that predominately used nurse anesthetists. Anesthesia safety continued to improve as indicated by a British study in the early 1980's, that used a procedure similar to that used by Beecher and Todd in the 1950's. The British study looked at 485,000 surgeries in which anesthesia was provided. There were 4000 deaths, only 3 of which were determined to be anesthetic related, reflecting an anesthesia mortality rate of 1:185,000. The Institute of Medicine report entitled "To Err is Human," published in 1999, reflects an even better anesthesia mortality rate of 1:200,000 to 1:300,000 cases. The Institute of Medicine report states: The gains in anesthesia are very impressive and were accomplished through a variety of mechanisms including improved monitoring techniques, the development and widespread adoption of practice guidelines and other systemic approaches to improving errors . . . . the success of anesthesia, was accomplished through a combination of technological changes, new monitoring equipment, standardization of existing equipment, information-based strategies including the development and adoption of guidelines and standards, application of human factors to improve performance such as the use of simulators for training, formation of the Anesthesia Patient Safety Foundation to bring together stakeholders form different disciplines, physicians, nurses, manufacturers, to create a focus for action and having a leader who would serve as a champion for the cause. Dr. Pine also addressed the recent study regarding anesthesia by Silber published in June 2000. This study examined 7,665 deaths following 217,000 hospital procedures for which medical bills were submitted to HCFA for Medicare reimbursement. The study attempted to characterize the type of anesthesia provider based on whether an anesthesiologist submitted a bill for providing anesthesia or supervising the anesthesia. The study assumed that a CRNA administered the anesthesia if either the CRNA billed for it, or if no bill was located. Moreover, instead of reviewing deaths that occurred within 48 hours after the surgery, the study counted all deaths which occurred within 30 days following surgery, and ignored any non-anesthesia related complications and deaths which were included in the 7,665 death toll. Conversely, the 7,665 deaths in 217,000 procedures produce a mortality rate of 1:28, nearly 100 times greater than the mortality rate in the 1950 Beecher and Todd study, and nearly 10,000 times what the 1999 Institute of Medicine study reflected as the anesthetic mortality rate. The greatly inflated and inconsistent death rate is highly questionable and provides little scientific support for the Board's proposed rule. With respect to Petitioners' argument relating to arbitrary and capricious mandate, the proposed Rule would not permit office-based surgeons to provide a choice of anesthesia provider for Level III office surgeries, since only one anesthesia provider is necessary or justified for Level III office surgery, and the proposed rule mandates the participation of an anesthesiologist. It is unreasonable and not economically feasible for the surgeon or the patient to pay for an anesthesiologist and a CRNA for the same procedure. Based on the current Rule's "choice of anesthesia provider" requirement in subsection (2)(b) of the existing Rule, the proposed anesthesiologist mandate for Level III surgery is inconsistent, confusing and illogical to the reasonable person.
