The Issue Whether Rule 64B8-9.009(6)(b)1.a., Florida Administrative Code, is an invalid exercise of delegated legislative authority pursuant to Section 120.52(8), Florida Statutes.
Findings Of Fact Stipulated Facts Section 458.331(1)(v), Florida Statutes, authorizes the Board to adopt rules establishing the standards of practice and care for particular physician practice settings. The Board is the agency that adopted Rule 64B8-9.009, Florida Administrative Code, regarding standards of care for office surgery. Petitioner, Victor Ortiz, is a Certified Registered Nurse Anesthetist (CRNA), and is licensed by the Board of Nursing pursuant to Chapter 464, Florida Statutes. Mr. Ortiz is not a member of the Florida Association of Nurse Anesthetists or the Florida Nurses Association. Mr. Ortiz provides anesthesia care to patients in various settings under the supervision of physicians licensed pursuant to Chapters 458 and 459, Florida Statutes. Among other functions, Mr. Ortiz orders preanesthetic medications; administers regional, spinal, and general anesthesia under protocol and the supervision of a physician; provides life support functions; and monitors patient condition during surgery and in the recovery room. Prior to April 15, 2002, the effective date of Rule 64B8-9.009(6)(b)1.a., Florida Administrative Code (the Rule), Mr. Ortiz administered anesthesia under the supervision of operating physicians for all types of office surgeries, including surgical procedures classified by the Board of Medicine as "level III." Mr. Ortiz provided anesthesia services to patients in level III office surgeries under the supervision of M.D. or D.O. operating physicians four or five days per week on average. The Rule requires that if the anesthesia provider is a CRNA, 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 in level III office surgeries. Since the adoption of the Rule, the physicians for whom Mr. Ortiz previously provided anesthesia services will no longer employ him for level III office surgeries because they believe that it is unnecessary and cost-prohibitive to pay Mr. Ortiz to provide the actual anesthesia services and an anesthesiologist to directly supervise him. Consequently, Mr. Ortiz' revenues have been reduced and his office practice has been substantially and adversely affected.
Findings Of Fact Respondent, Patricia Major, M.D., graduated from Harvard undergraduate school with honors; graduated with honors from New York University School of Medicine; served her internship at Yale New Haven Hospital, as well as completing a residency program and fellowship program in pulmonary diseases at Yale in 1974. She was certified in 1974 by the American Board of Internal Medicine. She was a teaching fellow at Yale during her pulmonary fellowship and had a faculty appointment thereafter at that same school. She was Assistant Director and Educational Coordinator at the Family Practices Residency Program for the University of Connecticut and from 1974 through 1976 had teaching appointments there. In 1976, she left New England and returned to Florida to practice internal medicine in Key West where she had grown up. During the period from 1976 to 1980, when she practiced medicine in Key West, she also worked with Emory University and the University of Miami as a clinician teaching medical students who were placed in Key West on rotating clerkships. She served as an emergency room physician at Florida Keys Memorial Hospital and was an admitting physician on the staff. In 1978 she was selected as one of five physicians to become the first civilians to go through the Navy's Diving Medical Officers Training Program and served as a civilian diving medical officer for the Navy in Key West. In 1980, the Board of Medical Examiners of the State of Florida brought charges against Respondent that resulted in a stipulation being entered into between Respondent and the Board that she would voluntarily cease practicing in Florida and relinquish her Florida license. The stipulation was signed in December, 1981, and her license was relinquished by Order of the Board in February, 1982. The charges that resulted in the initial suspension of Respondent's license and in the stipulation between the Respondent and the Board dealt with charges based on impairment due to drugs and alcohol. Respondent moved to Massachusetts where she practiced medicine under a temporary license and voluntarily participated in the Impaired Professionals Program for two years. From 1982 to 1984 she had twice-weekly urine screens under her contract between the assigned Massachusetts monitoring physician and herself. In no instance was there evidence of impairment or a positive urine screen during her Massachusetts stay. In 1984, Respondent returned to Florida and applied to the Board of Medical Examiners for permission to return to practice. On March 14, 1984, the Board of Medical Examiners entered an order reinstating Respondent's medical license for the State of Florida, placing her on probation for a period of three years and setting up a monitoring agreement under which Dr. John Buckner of the Island Clinic would serve as supervising physician for Respondent. From March, 1984, until April, 1986, Respondent worked at the Island Clinic with Dr. Buckner, seeing 15 to 25 patients a day. During that period of time, she only missed one working day, in September, 1985, when she was moving from one house to another and during the period of time immediately before and during her October, 1985 stay at South Miami Hospital. Respondent, and all of the witnesses who had personal knowledge of her contact with patients, denied that she ever treated or dealt with patients while under the influence of drugs or alcohol from 1984 until the current time. Iris Carleen Cervantes, who served as secretary to Dr. Buckner and is currently on the staff of Dr. Davidson, Respondent's current monitoring physician, has had the opportunity over two and one-half years to observe Respondent on a regular basis in her dealings with patients. She has been with Respondent socially as well. She has never seen Respondent drink alcoholic beverages. She uses Respondent as her personal physician and for all other members of her family. She is aware of the Respondent's regular visits to her psychiatrist, Dr. Jerrold Weinstock, and takes those into account in doing the scheduling for Dr. Major. She is similarly aware of Respondent's regular attendance at Alcoholics Anonymous meetings, has never heard Respondent disparage A.A.; and in fact, has a brother whom Respondent helped get into A.A. At no time has Cervantes ever seen any indication, even when Respondent has returned to the office late at night, of any use of drugs or alcohol. Linda Susan Park, a counselor at the Delphus Drug and Alcohol Treatment Center at Florida Keys Memorial Hospital for the last three and one-half years, knows Respondent both personally and professionally. She has never seen Respondent under the influence of any mood-altering chemicals. Although they go out socially together, she has never seen Respondent order an alcoholic beverage. When they are together, they talk program, i.e., A.A. steps. Parks has regularly seen Respondent at A.A. meetings, and they attend a number of the same groups including a Wednesday night women's group called The New Beginnings Group. Parks is aware of the interest Respondent has shown in drug and alcohol-impaired nurses at Keys Memorial and of her attendance at the impaired nurses Caducues meetings. Respondent has worked with the Delphus Program at Florida Keys Memorial Hospital referring a number of patients to the program. Park has seen the Respondent under extremely stressful situations, particularly in the past year; and has seen her act only appropriately. With the Board's approval, Respondent has also worked with indigent patients at the Health Care Center at Florida Keys Memorial Hospital since August, 1986. The Director of that program, Thomas C. Puroff, testified regarding her employment there. Respondent was originally hired on a temporary basis to cover for the primary care physician for three weeks. The Director's assessment of her initial period of employment at the Health Care Center is as follows: The staff was very, very pleased with her performance, and I was very pleased with her performance. The staff felt that they were learning a lot from her, that she was an exemplary doctor who explained why she was doing things with patients and it became a learning process for our nurse practitioners and nurses. Her interaction with the receptionist, administrative assistant was very high level, very positive, and the patients loved her. And both--well, later on when we did hire her on a one day per week basis to fill in when the regular doctor could not be there, a lot of patients would call and specifically request an appointment when she was going to be there. (Transcript, P. 199) The Health Care Center ultimately hired the Respondent for one to two days a week when the other physician was not there. She works the longest day of the stretch, which is a ten-hour day. The Director describes the job as a high stress one in which he has seen no difficulty in handling stress on Respondent's part. He has never seen any indication of impairment of faculties or inability to handle her job in any fashion on Respondent's part. When he hired Respondent, Puroff had full knowledge that she had problems with the Board of Medical Examiners, had been assigned a monitoring physician, had been brought in restraints to the emergency room at Florida Keys Memorial Hospital and had been committed under the Baker Act in September of 1985, that she was an alcoholic who attended A.A., and that she regularly visited a psychiatrist. None of these matters were kept secret from him. Karl Michael Davidson, M.D., who became Respondent's monitoring physician after Dr. Buckner abruptly left town in April, 1986, has similarly seen no sign of any kind of impairment during the time he has worked with her. He has never seen her indulge in any drugs or alcohol. He knows that she regularly sees her psychiatrist. He has received no complaints from anyone in the medical community, the patient community, or the general community of Key West with regard to Respondent since he has served in a monitoring capacity for her. Even Sally Parr who testified on behalf of the Petitioner denied that Respondent ever used alcohol when she was in a situation in any way connected with patients. Regarding the change of monitoring physicians in April, 1986, the testimony of Respondent and her witnesses was consistent and uncontradicted, with Petitioner presenting no facts other than those stipulated. The individual having the most knowledge regarding the circumstances under which Dr. Buckner left Key West, was his secretary, Iris Cervantes. She, like the other witnesses, was aware that he had gone to look at a number of schools and other medical positions. He would say he was going to leave, but he always came back. On April 6, 1986, Buckner's wife told Respondent the Island Clinic was being closed and Buckner was leaving. On April 7, the locks on the doors to the Island Clinic were changed. Cervantes was one of two people to have a new key; Respondent and the other doctors practicing with Dr. Buckner were not given keys. This left Respondent in a position where she could not write some pharmaceutical prescriptions, all appointments had to be cancelled, and there was no way to treat ongoing patients who were ill at the time. When the locksmiths changed the locks, Respondent contacted Buckner to ask if he knew what he was doing and if he were going to be gone permanently. He indicated that he had started working in California, but he did not know whether it would be permanent. He said that he had spoken with Dr. Davidson and asked him to act as a temporary supervising physician in addition to himself. Respondent spoke with Dr. Davidson who said that she was welcome to see patients at his office and that he would monitor until Buckner decided what he was doing. They spoke about immediately notifying the Board of the change in her office location. It was her impression that Dr. Davidson had actually notified the Board with a handwritten memo the first day she was there and that was how the investigator from the Department knew how to find her when the investigator came to see Respondent at Davidson's office on April 18, 1986. On that date Davidson also discussed with the investigator Buckner's abrupt departure which might be permanent. Respondent ultimately wrote the Board herself. That correspondence dated April 22, 1986, was received by the Department of Professional Regulation on April 28, 1986, the same day on which the Department received from Davidson his notification letter dated April 17, 1986. Four to six weeks after that letter, Dr. Davidson and Respondent were advised that the Board had received the information and would consider Dr. Davidson as her supervisor. On August 2, 1986 Davidson and Respondent appeared before the Board of Medical Examiners and received formal approval. The remaining allegations involve two separate incidents occurring during the week of September 16, 1985. At that time, and since January of that year, Respondent was living in the home of Sally Parr, an Assistant State Attorney for Monroe County. It was Parr's testimony that several months after Respondent moved in, Respondent began to drink wine on a regular basis sometimes to the point of intoxication. Parr is the sole person to testify to having seen Respondent drink alcoholic beverages. Other witnesses testified to Parr's own problems with alcohol. The emotional relationship between Parr and Respondent from March, 1985, until September, 1985, was "stormy" and "tremendously emotional." The two of them attended therapy with Dr. Jerrold Weinstock. On September 16-17, 1985, all of this emotionalism culminated in Parr calling the emergency number 911. During the evening of Monday, September 16, Parr's sister arrived in town. There were highly controverted scenes which both Parr and Respondent described. The two participants were clearly emotionally charged, angry, and upset. It was Parr's testimony that Respondent walked into the back bedroom and with a syringe in her hand with a pale yellow fluid in it, lifted her shirt and injected that material into her chest under her left breast Saying she was going to kill herself. According to Parr, Respondent said the fluid was 100 percent xylccaine and she would die in one minute. Parr then called 911, Respondent told her she was a fool to believe that, and Respondent left the house and drove away. Parr also confusedly describes a later scene that night with Respondent and another syringe and more light yellow fluid. Officer Cynthia Tingley responded to that call from Parr. The report was treated as one for an "attempted suicide". At no time did Ms. Parr tell the officer that Respondent was not in danger or that Respondent had told Parr that she was "a fool" to believe that this was a way to kill oneself. In the opinion of the investigating officer, Parr had an odor of alcoholic beverage on her breath. The officer had no personal knowledge that Respondent had administered the legend drug to herself. She did note an empty bottle of xylocaine in the room but no syringe was found. Later the officer was called to where another officer had stopped Respondent and had given her a citation for careless driving. Respondent was cooperative and did not seem to be having health problems, although she did appear to be under a lot of stress and appeared anxious. Neither officer made any attempt to detain Respondent after the stopping. Under Parr's version of this event, it ended with Respondent refusing to go to sleep in the back bedroom and only agreeing to go to sleep if she could sleep in Parr's room. That occurred and ended the evening. Respondent continued to live at the house, and on Thursday Parr and her sister left for a short vacation. Parr testified that she called from out-of-town to tell Respondent that she was not coming back to the house unless Respondent had moved out. Respondent agrees that Parr called and told her that but adds that Parr had promised to go on vacation with Respondent and told Respondent to arrange that vacation while Parr and her sister were gone. Respondent specifically denies that she made a suicide attempt or attempted to give the impression she was trying to commit suicide on September 16-17, 1985, or any other time. She denies that the events described by Parr occurred but agrees that it was a very confusing, emotional night. She denies that there was any further incident when she returned that night and only recalls them both being pretty tired and having gone to bed. Dr. Jerrold Weinstock, Respondent's treating psychiatrist and the individual to whom Parr and Respondent had gone for counselling, testified that the only description of the xylocaine/suicide incident he received came from Parr, not from Respondent. No information that Weinstock gained from his psychotherapy of Respondent indicated that Respondent's version of the event (or non-event) was incorrect. It is specifically found based upon the credibility of the witnesses that Respondent did not inject herself or attempt to inject herself with anything and specifically not with xylocaine. The second incident of that week occurred on Friday evening, September 20-21, 1985. This was the evening when Parr called Respondent and told her to move out of the house. Respondent describes that scene as follows. She [Parr] called. We had arranged that she would call at that time. I had seen my last patient about 5:30 or 5:45 and I was waiting at home for her call . . . She started screaming at me to get out of her home, that she did not want me there when she got back. I was stunned because I was making arrangements for vacation. I said, "What about the vacation?" She said, "I lied to get out." And I said, "Well, what will you do." "Call the police," she said. "I know people on the police force and I won't hesitate to use them." And then she hung up on me. (Transcript, P. 248) Respondent had taken steps during the day to arrange a trip to New York and Connecticut because Parr had never been to New York. An acquaintance came by while Respondent was still sitting stunned and asked her if she wanted to go to the Black Angus and have a drink. Respondent went with this individual to the Black Angus and had three very strong drinks there. She realized that she was feeling intoxicated after the third drink. She asked the woman, who was driving, to drop her off at Sally's house, but the woman wanted to go downtown to a few more bars. Respondent pleaded to be dropped off, and her companion became belligerent. Ultimately, the acquaintance assaulted Respondent tearing her shirt off, punching her in the face, hitting her about the head, grabbing her purse and pulling it away from her. During the scuffle, Respondent even lost her sandals. Petitioner has not controverted this account. Cervantes and Buckner both confirmed the bruises and scratches from the fight. Cervantes also described an incident a few days later whereby the same woman came into the Clinic, gave Cervantes some earrings she said she had taken out of Respondent's purse, and slashed the tires on Respondent's car on her way out. Respondent was left intoxicated, running, frightened, with no top on and three miles from Parr's house. She did not have her keys which had been in her purse and could not get into the clinic but felt she could get into Parr's house if she could get there. She felt intoxicated and becoming more so, uncertain whether it was the alcohol or being beaten that was affecting her. She was disoriented and embarrassed to be running down the street wearing only a pair of shorts. She crawled under a garage on the side of the road to sleep to clear her head to find a solution to her predicament. She was awakened by police officers but said nothing in response to questioning. Respondent was taken by the police to Florida Keys Memorial Hospital. When the police officers tried to transport Respondent, she became physically violent, kicking at the officers and attempting to kick out the windows of the patrol car. When she arrived at the hospital, she was physically restrained with arm and leg restraints. A drug analysis performed on Respondent at the hospital showed her blood alcohol level to be 0.235 percent. Respondent was next transported to Marc House in Marathon, Florida. She was involuntarily committed under the Baker Act for that one night. The next morning, Dr. Jesse Sewell, Director of Marc House, spoke with Respondent, determined there was absolutely no reason for Respondent to be there, and called Buckner to pick up Respondent and transport her back to Key West. Dr. Buckner did and took Respondent to Parr's house so she could move out her belongings. Respondent and Buckner discussed the episode at great length and she got in touch with Dr. Weinstock. Buckner and Respondent called her probation officer with the Department of Professional Regulation, a Diane Robie, who advised them to contact Dr. Roger Goetz, head of the Florida Impaired Physicians Program. Buckner called Goetz and described the incident that resulted in Respondent being committed overnight. He told Goetz that Respondent had moved out of the place where she had been living which seemed to have precipitated the disturbance; that she was in daily contact with her psychiatrist; that she had started attending A.A. meetings daily as recommended to someone who has had an episode of drinking; and that she would bring her support systems together. Goetz suggested going for evaluation at South Miami Hospital with Dr. Lynn Hankes. When Respondent was evaluated by Hankes, he recommended entry into South Miami's treatment program. Respondent went back to Key West and conferred with Buckner, Weinstock, and Goetz. Although Weinstock believed the inpatient program at South Miami would be therapeutically counterproductive, Respondent followed the recommendations of Goetz and Hankes and entered the treatment program on October 6, 1985. Buckner (whose deposition was taken prior to his departure from Key West in April, 1986) considers Respondent the best internal medicine doctor in Monroe County. Since he had noticed nothing wrong with Respondent through Friday afternoon, September 20, 1985, he was surprised by the telephone call from Dr. Sewell at Marc House on Saturday morning. When Buckner spoke with Weinstock that day, Weinstock explained that Respondent completely removes her emotional problems from her professional self. After the Friday/Saturday Marc House incident, Respondent finished her weekend move from Parr's house on Monday and came back to work on Tuesday. From Tuesday until she entered South Miami's treatment program, her performance as a practicing physician remained exemplary, analytical and calm. Respondent entered the program committed to making the program work and seeking insights into the nature of her disastrous interpersonal relationships as well as the episode that led to her admission to Marc House. Dr. Lynn Hankes testified that Respondent is a chronic alcoholic who will always be an impaired physician. He described in detail the South Miami Treatment Program beginning with the first phase of detox and assessment. He admitted that Respondent did not require detoxification and that she suffered no abstinence syndrome or withdrawal syndrome. She became immediately oriented to the program and began interacting with her counselor. However, Dr. Hankes believes that Respondent only intellectually admitted to the problem and that she was preoccupied with only interacting with the other medical professionals on the unit. He described at some length Respondent's "negative limit testing" and her preoccupation with the medical professionals on the unit. He regarded her as "sabotaging her own treatment". For example, Respondent did not initially tell program personnel that she sometimes had a glass of wine at dinner over the last several months or that she shared a marijuana cigarette on her way from Key West to admit herself into South Miami Hospital although she did disclose that information during her stay in the program. It is his opinion that there is a clear medical indication for extended treatment in a secondary facility for many reasons. Basically, in his opinion, it was a bottom line of an intellectual admission of the disease with only minimal acceptance. He administratively discharged Respondent from the program on October 31, 1985 just prior to her completing the program because she refused to accept his recommendation for extended care for an indefinite period of time. Dr. Hankes did not see Respondent after October 31, 1985 in any capacity. All of his testimony was based on information which he had prior to October 31, 1985. Dr. Hankes admitted that the only limit testing, rule breaking that Respondent had engaged in was that she spoke to other medical professionals, she spoke to male patients in their room while she stood at the door, and she walked a friend to the lobby of the hospital but did not leave the premises. He also observed isolation tendencies on her part. His dire predictions of doom have not proven accurate. In the subsequent year and a quarter Respondent has stayed sober and practiced medicine successfully with no further incident. It was Buckner's impression that the major reason Respondent was being required to go into the hospital for the inpatient treatment was because other impaired physicians in the Key West area had had to go through the program, and they were unhappy that she had somehow missed it. Buckner encouraged Respondent to enter the treatment program, even against the advice of her psychiatrist, so that the Board would be on her side after she "completed the drill." Buckner spoke with her counselor and therapist regularly during the time she was at South Miami Hospital and got indications that everything was progressing well and that she would be back to Key West to practice at the scheduled time. Buckner went to South Miami Hospital three weeks after Respondent's admission to meet with Dr. Hankes on a Saturday. Hankes did not show up for the appointment, but Buckner later reached him by phone. Hankes told Buckner that Respondent was progressing fine, although she still had some problems. Hankes said Respondent would be back in Key West practicing the next week and could have outpatient treatment with Dr. Weinstock. Buckner returned to Key West and told his staff to schedule Respondent for patients the next week when she would return. On Monday Respondent telephoned to tell him that Hankes had changed his mind, that they were not going to release her, and that she was going to have to sign herself out. No explanation has been offered as to why Hankes changed his mind between Saturday and Monday so radically from outpatient treatment with Respondent's treating psychiatrist to indefinite inpatient hospitalization. Buckner and Weinstock agreed the best treatment for Respondent was to get her back practicing medicine. Buckner contacted Cecilia Bradley, the attorney representing the Department and the Board, asking for direction. Bradley advised Buckner that he would have to personally decide whether Respondent was a threat to the community. He saw no such threat. Respondent returned to the Island Clinic and resumed her practice. Buckner saw her there on a daily basis, and her performance was, in his opinion, the same as before, "absolutely flawless." When Respondent did not accept Hankes' recommendation of indefinite long-term treatment in Mississippi, she became, in Dr. Goetz's opinion, in noncompliance with the Florida statute on impaired physicians. Dr. Goetz subsequently reported her to the Department of Professional Regulation for her failure to continue satisfactorily in the program. Goetz admitted that his role as Director of the program was one of an administrative officer, and he has offered no opinion as to whether Respondent is in fact impaired. Goetz has received no information that Respondent's impairment, if any, has in any way affected her practice or patient contact. All the information that Goetz relies on is information prior to Respondent's discharge from South Miami Hospital on October 31, 1985. It was Buckner's understanding, and that of Respondent, that she had not violated the Order of the Board in having an instance where she "slipped" with regard to drinking. Dr. Goetz agreed with that assessment a "slip" can be a part of a rehabilitation program. Linda Parks, Diane Robie, and Dr. Weinstock agree with that assessment. Respondent could not have financially afforded the Mississippi program. Despite the testimony of Hankes and Goetz that Respondent could have gone there for free, Goetz did not tell her that, Hankes did not know what the financial arrangement was, and the Director of that program whom Respondent personally contacted regarding the program did not mention such a possibility. Jerrold Weinstock has been Respondent's treating psychiatrist since 1984. His opinion is that there is no basis for the allegation that Respondent be considered an impaired physician incapable of rendering safe, quality, and competent services to her patients. In fact, Weinstock refers members of his own family to her. That opinion is shared by two independent psychiatrists, Stanley I. Holzberg, M.D., and Milton Burglass, M.D. Dr. Holzberg examined Respondent initially on behalf of the Florida Impaired Physicians Program in 1983; reexamined her at the request of the Department in February, 1984; and saw her for a third time at her own request in November, 1985, following Respondent's discharge from South Miami Hospital. On all of the occasions when he examined Respondent, Holzberg opined that she could practice medicine with skill and safety with the conditions that she have treatment and monitoring. Holzberg considers the treatment she is receiving from Weinstock, including the prescription of an antidepressant, as appropriate long-term treatment. He agrees with Weinstock and Buckner that long-term inpatient hospitalization would not be helpful to Respondent. Holzberg further agrees with Weinstock that Respondent's major illness is chronic depression, the affective disorder. Dr. Milton Burglass evaluated Respondent on March 25 and April 2, 1986, and reached the same conclusion. Burglass administered a full series of psychological tests to Respondent, including the Minnesota Multi-Phasic' Personality Inventory; the Beck Depression Inventory; the Cattell Use for Tension and Anxiety Survey Schedule; the Rotter Incomplete Sentences Blank; the Cattell Assertive Behavior Survey Schedule; the Cattell Thought Stopping Survey Schedule; and the Standardized Medical and Personal History Form. He spent, in addition, a total of five hours interviewing Respondent, and he went over all the records from other psychiatric and related medical evaluations that she had had from 1980 forward. Burglass found nothing to suggest that Respondent is incapable of practicing medicine with skill and safety. Burglass believes that people can, in fact, function normally and be able to perform professionally in their chosen profession after recovering from a chemical dependency, be it drug or alcohol. Burglass specifically opined that Respondent is not impaired.
Recommendation Based upon the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED that a final order be entered: Dismissing with prejudice the complaint filed against Respondent in DOAH Case NO. 86-0469; Finding Respondent guilty of the allegation contained in the Administrative Complaint filed in Case No. 86-2065 but taking no disciplinary action against her, and Allowing Respondent to continue to practice medicine under reasonable monitoring conditions until the period of her probation has been completed on March 15, 1987. DONE AND ORDERED this 5th day of March, 1987, in Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of March, 1987. APPENDIX TO RECOMMENDED ORDER DOAH Case Nos. 86- 0469 and 86-2065 Rulings are made as to each of Petitioner's proposed findings of fact as follows: 1-2. Adopted. 3. Rejected as irrelevant. 4-5. Adopted. 6-7. Rejected as not supported by the weight of the credible evidence. Rejected as being contrary to the weight of the credible evidence. Adopted. Rejected as not supported by the weight of the credible evidence. Adopted. Rejected as being a statement taken totally out of context. Adopted. Rejected as being contrary to the weight of the credible evidence. 15-17. Adopted. Rejected as not supported by the weight of the credible evidence. Adopted. Rejected as not supported by the weight of the credible evidence. First two sentences adopted; third sentence rejected as being contrary to the weight of the credible evidence. 22-23. Adopted. Rejected as being secondary. Adopted. First sentence rejected as being contrary to the weight of the credible evidence. Second sentence adopted. Rejected as being contrary to the weight of the credible evidence. 28-29. Adopted. 30-32. Rejected as not supported by any evidence. Rejected as being secondary. Rejected as being contrary. Rejected as being irrelevant. Rejected as being secondary. Adopted. Rejected as not supported by any evidence. Rejected as being irrelevant. 40-45. Adopted. Rejected as being irrelevant. Adopted. Rulings are made as to each of Respondent's proposed findings of fact as follows: 1-27. Adopted. 28. Rejected as being redundant. 29-32. Adopted. 33. Rejected as being redundant. 34-39. Adopted. 40-41. Rejected as being unnecessary. 42-43. Adopted. COPIES FURNISHED: Leslie Brookmeyer, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Elizabeth Du Fresne, Esquire 2950 S.W. 27th Avenue, Suite 10 Coconut Grove, Florida 33133 Nathan Eden, Esquire 417 Eaton Street Key West, Florida 33040 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth Executive Director Board of Medical Examiners 130 N. Monroe Street Tallahassee, Florida 32301
The Issue Whether the Florida Medical Association and Florida Association of Physicians Assistants have standing to initiate this challenge to the proposed rules. (See Section 120.56(3) Florida Statutes.) Whether proposed Rules 64B1-4.010 and 64B1-4.011, Florida Administrative Code, constitute invalid exercises of delegated legislative authority because they exceed the Board of Acupuncture's rulemaking authority contained in Section 457.104, Florida Statutes. (See Section 120.52(8)(b), Florida Statutes.) Whether proposed Rules 64B1-4.010 and 64B1-4.011, Florida Administrative Code, constitute invalid exercises of delegated legislative authority because they enlarge, modify, or contravene the provisions of Section 457.102, Florida Statutes. (See Section 120.52(8)(c), Florida Statutes.)
Findings Of Fact It was stipulated that Petitioner FMA is organized and maintained for the benefit of approximately 16,000 licensed allopathic and osteopathic Florida physicians. FMA's standing in this proceeding has always been at issue. The foregoing stipulation encompasses all of the factual allegations about Petitioner contained in the Petition. Dr. Steven West, an allopathic physician licensed in the State of Florida pursuant to Chapter 458, Florida Statutes, and a member of FMA, testified as follows: Well, we have two interests. Certainly one interest is that we want to make certain that only qualified individuals and practitioners treat patients and diagnose patients because we have an interest in the health and welfare of the people of the State of Florida. Secondly, we have an interest in making certain that all of the hard work and time that we have spent in our training remains valuable and is considered unique and important. And so we have a concern about the devaluation of the practice of medicine. (TR-17) It was stipulated that there is only one Respondent, the Board of Acupuncture, created by the Florida Legislature and placed within the Florida Department of Health. It is axiomatic that Respondent has standing herein. There were no stipulations as to the standing of either intervenor, and both the Board and FSOMA have asserted in their respective Proposed Final Orders that FAPA, as well as FMA, is without standing to bring this rule challenge. However, no party has contested the veracity of the factual statements concerning standing in either Petition to Intervene, and no party opposed intervention. The Petitions to Intervene of FAPA and FSOMA were granted, subject to proving-up standing at hearing. Even stipulations as to standing do not preclude consideration of standing as a matter of law. Florida Medical Ass'n., Inc., et al. v. Dept. of Health, Florida Bd. of Nursing, et al., DOAH Case No. 99-5337RP (Final Order March 13, 2000), per curiam affirmed Bd. of Nursing, et al. v. Florida Medical Ass'n., Inc., et al, So. 2d (Fla. 1st DCA 2001). Therefore, under these circumstances, and applying that case, the intervenors' factual allegations for purposes of standing may be taken as true for findings of fact, but each intervenor's status still depends upon that of the respective party upon whose behalf each intervenor entered this case. Therefore, with regard to the status of FAPA, it is found that: FAPA is organized and maintained for the benefit of the licensed Florida physicians assistants who compromise [sic] its membership and has as one of its primary functions to represent the interests of its members before various governmental entities of the State of Florida, including the Department of Health and its boards. (FAPA Petition to Intervene) Therefore, with regard to the status of FSOMA, it is found that: FSOMA is a Florida nonprofit corporation comprised of over one-third of the doctors of oriental medicine and licensed acupuncturists under the regulatory aegis of the Board of Acupuncture, State of Florida Department of Health, Chapter 457, F.S., with a mission to represent the acupuncture and oriental medicine practitioner interests of its members in judicial, administrative, legislative and other proceedings. (FSOMA Petition to Intervene) The text of proposed Rule 64B1-4.010, set forth in the petition is no longer correct, because it has been altered by Notices of Change, pursuant to Chapter 120, Florida Statutes. Rule 64B1-4.010, as currently proposed, would provide: Traditional Chinese Medical Concepts, Modern Oriental Medical Techniques. Traditional Chinese medical concepts and modern oriental medical techniques shall include acupuncture diagnosis and treatment to prevent or correct malady, illness, injury, pain, addictions, other conditions, disorders, and dysfunction of the human body; to harmonize the flow of Qi or vital force; to balance the energy and functions of a patient; and to promote, maintain, and restore health; for pain management and palliative care; for acupuncture anesthesia; and to prevent disease by the use or administration of: stimulation to acupuncture points, ah-shi points, auricular points, channels, collaterals, meridians, and microsystems which shall include the use of: akabane; allergy elimination techniques; breathing; cold; color; correspondence; cupping; dietary guidelines; electricity; electroacupuncture; electrodermal screening (EDS); exercise; eight principles; five elements; four levels; hara; heat; herbal therapy consisting of plant, animal, and/or mineral substances; infrared and other forms of light; inquiring of history; jing-luo; listening; moxibustion; needles; NAET; observation; oriental massage -- manual and mechanical methods; palpation; physiognomy; point micro-bleeding therapy; pulses; qi; xue and jin-ye; ryodoraku; san-jiao; six stages; smelling; tongue; tai qi; qi gong; wulun- baguo; yin-yang; zang-fu; Ayurvedic, Chinese, Japanese, Korean, Manchurian, Mongolian, Tibetan, Uighurian, Vietnamese, and other east Asian acupuncture and oriental medical concepts and treatment techniques; French acupuncture; German acupuncture including electroacupuncture and diagnosis; and, the use of laboratory test and imaging findings. (Emphasis supplied). The "authority" cited by the Board for proposed Rule 64B1-4.010 is Sections 457.102 and 457.104, Florida Statutes. The Board cites the "law implemented" for Rule 64B1- 4.010 as Section 457.102, Florida Statutes. The text of Rule 64B1-4.011, as set forth in the petition also is no longer correct, because it has been changed by Notices of Change, pursuant to Chapter 120, Florida Statutes. Rule 64B1-4.011, as currently proposed, would provide: Diagnostic techniques which assist in acupuncture diagnosis, corroboration and monitoring of an acupuncture treatment plan or in making a determination to refer a patient to other health care providers shall include: traditional Chinese medical concepts and modern oriental medical techniques, recommendation of home diagnostic screening; physical examination; use of laboratory test findings; use of imaging films, reports, or test findings; office screening of hair, saliva and urine; muscle response testing; palpation; reflex; range of motion, sensory testing; thermography; trigger points; vital signs; first-aid; hygiene; and sanitation. (Emphasis supplied). The "authority" cited by the Board for proposed Rule 64B1-4.011 is Sections 457.102(1) and 457.104, Florida Statutes. The Board cites the "law implemented" for proposed Rule 64B1-4.011 as Section 457.102 (1), Florida Statutes. Section 457.104, Florida Statutes, currently provides: The board has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement provisions of this chapter conferring duties upon it. Section 457.102, Florida Statutes, currently provides: "Acupuncture" means a form of primary health care, based on traditional Chinese medical concepts and modern oriental medical techniques, that employs acupuncture diagnosis and treatment, as well as adjunctive therapies and diagnostic techniques, for the promotion, maintenance, and restoration of health and the prevention of disease. Acupuncture shall include, but not be limited to, the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body and the use of electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies, as defined by board rule. "Acupuncturist" means any person licensed as provided in this chapter to practice acupuncture as a primary health care provider. "Board" means the Board of Acupuncture. "License" means the document of authorization issued by the department for a person to engage in the practice of acupuncture. "Department" means the Department of Health. "Oriental medicine" means the use of acupuncture, electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies. "Prescriptive rights" means the prescription, administration, and use of needles and devices, restricted devices, and prescription devices that are used in the practice of acupuncture and oriental medicine. (Emphasis supplied) The Board asserts that the use of a comma between "other adjunctive therapies" and "as defined by board rule" in the second sentence of Section 457.102(1), Florida Statutes, establishes that the clause "as defined by board rule" applies to "the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body and the use of electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies," and those practices "included but not listed." Rule 64B1-3.001, Florida Administrative Code, most recently amended February 27, 1992, addresses "adjunctive therapies" of acupuncturists as follows: Acupuncture diagnostic techniques shall include but not be limited to the use of observation, listening, smelling, inquiring, palpation, pulses, tongues, physiognomy, five element correspondence, ryordoraku, akabani, German electro acupuncture, Kirlian photography, and thermography. (Emphasis supplied). * * * Adjunctive therapies shall include but not be limited to: Nutritional counseling and the recommendation of nonprescription substances which meet the Food and Drug Administration labeling requirements, as dietary supplements to promote health; Recommendation of breathing techniques and therapeutic exercises; and Lifestyle and stress counseling; The recommendation of all homeopathic preparations approved by the Food and Drug Administration and the United States Homeopathic Pharmacopeia Committee; and Herbology. This rule has not been challenged.1 Likewise, Rule 64B1-4.008, Florida Administrative Code, promulgated December 24, 2000, has not been challenged,2 and defines "adjunctive therapies," of acupuncturists as follows: Adjunctive therapies shall include the stimulation of acupuncture points, ah-shi points, auricular points, channels, collaterals, meridians, and microsystems with the use of: air; aromatherapy; color; cryotherapy; electric moxibustion; homeopathy; hyperthermia; ion pumping cords; iridology; kirlian photography; laser acupuncture; lifestyle counseling; magnet therapy; paraffin; photonic stimulation; recommendation of breathing techniques; therapeutic exercises and daily activities; sound including sonopuncture; traction; water; thermal therapy; and other adjunctive therapies and diagnostic techniques of traditional Chinese medical concepts and modern oriental medical techniques as set forth in Rule 64B1-4.010. (Emphasis supplied). Acupuncturists are, by law, "primary health providers." Subsections 457.102(1) and (2), Florida Statutes. (See Finding of Fact 14). A primary health care provider is a professional to whom patients can go without a referring physician and who, by diagnosis and treatment, assumes responsibility for patients' appropriate care. Allopaths and osteopaths are also primary health care providers. FSOMA asserted that the challenged rules are supported by Section 457.1085, Florida Statutes, which provides, 457.1085 Infection control--Prior to November 1, 1986, the board shall adopt rules relating to the prevention of infection, the safe disposal of any potentially infectious materials, and other requirements to protect the health, safety, and welfare of the public. Beginning October 1, 1997, all acupuncture needles that are to be used on a patient must be sterile and disposable, and each needle may be used only once. The traditional course of education, training, and experience for allopathic physicians and osteopathic physicians involves four years of undergraduate college education, four years of medical school, one-year internship, and one to two years of residency, but is more specifically set out for licensing purposes in Sections 458.311-458.318, Florida Statutes, for allopaths, and Sections 459.0055-459.008, Florida Statutes, for osteopaths. All of these courses/periods of learning involve, to a greater or lesser degree, learning to use and interpret modern laboratory and imaging tests. The traditional course of education for acupuncturists involves only two years of college and four years of acupuncture schooling, but is more specifically set out for licensing purposes by Section 457.105, Florida Statutes. Four hours per week for one year is about the extent of training in the use and interpretation of modern laboratory tests and imaging films afforded acupuncture students. There clearly are more stringent requirements for licensure of allopaths and osteopaths than for acupuncturists. Allopaths and osteopaths clearly spend more time training in the ordering, use, and interpretation of modern laboratory tests and film imaging. As previously stated (see Finding of Fact 14), an acupuncturist, as defined by law, . . . employs acupuncture diagnosis and treatment, as well as adjunctive therapies and diagnostic techniques for the promotion, maintenance, and restoration of health and the prevention of disease . . .(Emphasis supplied). Section 458.305(3), Florida Statutes, defines the "practice of medicine" as "Practice of medicine" means the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or physical or mental condition. (Emphasis supplied). Section 459.003(3), Florida Statutes, defines the "practice of osteopathic medicine" as "Practice of osteopathic medicine means the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition, which practice is based in part upon educational standards and requirements which emphasize the importance of the musculoskeletal structure and manipulative therapy in the maintenance and restoration of health. (Emphasis supplied). The following statutes express the Legislature's intent with regard to regulation of acupuncturists, allopaths, and osteopaths: 457.101 Legislative Intent - The Legislature finds that the interests of the public health require the regulation of the practice of acupuncture in this state for the purpose of protecting the health, safety, and welfare of our citizens while making this healing art available to those who seek it. 458.301 Purpose - The Legislature recognizes that the practice of medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The Legislature finds further that it is difficult for the public to make an informed choice when selecting a physician and that the consequences of a wrong decision could seriously harm the public health and safety. The primary legislative purpose in enacting this chapter is to ensure that every physician practicing in this state meets minimum requirements for safe practice. It is the legislative intent that physicians who fall below minimum competency or who otherwise present a danger to the public shall be prohibited from practicing in this state. 459.001 Purpose - The Legislature recognizes that the practice of osteopathic medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The Legislature finds further that it is difficult for the public to make an informed choice when selecting an osteopathic physician and that the consequences of a wrong decision could seriously harm the public health and safety. The primary legislative purpose in enacting this chapter is to ensure that every osteopathic physician practicing in this state meets minimum requirements for safe and effective practice. It is the legislative intent that osteopathic physicians who fall below minimum competency or who otherwise present a danger to the public shall be prohibited from practicing in this state. There was competent testimony that allopathic and osteopathic physicians may utilize acupuncture in the practice of their professions, as defined respectively at Sections 458.305(3) and 459.003(3), Florida Statutes. They are permitted to perform acupuncture, although their traditional course of professional education and training involves fewer (or no) hours of acupuncture education and training than are required under Chapter 457, Florida Statutes, the acupuncture practice Act. Presumably, that is because their respective professions and the Legislature have recognized that the training of allopaths and osteopaths encompasses the appropriate skills for acupuncture. However, if they perform acupuncture, they can only be disciplined under their respective practice Acts, Chapters 458 and 459, Florida Statutes. The Board of Acupuncture has no authority to discipline them. The record is silent as to whether or not Physicians Assistants, whether FAPA members or not, may legitimately perform acupuncture. To "practice medicine" or to "practice osteopathic medicine," as those terms have been respectively defined by Sections 458.305(3) and 459.003(3), Florida Statutes, do not render modern laboratory tests and imaging films unique to medical or osteopathic diagnosis. However, Harvey Kaltsas, a Florida-licensed acupuncturist and a member of the Board of Acupuncture, testified that "traditional Chinese medical concepts," and "modern oriental medical techniques" include gynecological and obstetric services, abortions, and cut-and-stitch surgery and that these services are performed by acupuncturists in China today. He further testified that the Board of Acupuncture believed that these tasks are "better handled" by allopathic physicians, and therefore the Board of Acupuncture has promulgated rules (most particularly the unchallenged rules addressing adjunctive therapies) which do not list these services. The Board believed that by not listing these services, it was prohibiting its licensees from performing them. The Board further asserts that its challenged rules only define "traditional Chinese medical concepts" and "modern oriental medical techniques" as used in Chapter 457, Florida Statutes, to include the use of laboratory tests and imaging findings and to clearly specify that "diagnostic techniques" for acupuncturists also include the use of modern laboratory test findings, and use of imaging films, reports, and test findings. There was competent testimony that modern laboratory Chinese medical tests on urine and feces evolved from ancient and traditional concepts and are regularly used in China and the orient by acupuncturists today. There was competent testimony that comparison of x-rays, at least for gross chest problems or for placement of acupuncture needles, is taught in an acupuncture college in Florida as part of its usual and required curriculum today. Allopaths and osteopaths use laboratory tests, imaging films, and reports thereon to reach an initial diagnosis and to test and revise that diagnosis through a course of treatment. Dr. West testified that he relies on his own "reading" of x-rays for his specialty of cardiology, while other allopaths may rely on a radiologist to read x-rays for them or may rely on a radiology report. Diagnosis is also a part of acupuncture. Acupuncturists want to use modern laboratory tests and imaging films to reach an initial diagnosis and to test that diagnosis through a course of treatment. They want to use laboratory tests and film imaging to properly direct their own initial treatment efforts, such as using urinalysis to eliminate a urinary tract infection before treating muscles and bones for a backache. They want to determine blood clotting speeds via an INR test on persons presenting with a prescriptive history of blood-thinner use, such as Coumadin, before using acupuncture needles. They want to be able to eliminate conditions they do not feel competent to treat, i.e. cancer, and to properly refer those patients for treatment by allopaths and osteopaths. Modern laboratory test results are variously formatted, sometimes as a report or value and result. X-rays are frequently the subject of a narrative report from a radiologist. Some modern imaging results are available directly to the public, like mobile TB screenings.
The Issue Whether the Division of Administrative Hearings has jurisdiction to conduct a formal hearing under the provisions of Sections 120.569 and 120.57(1), Florida Statutes, if the Petition for Relief was not timely filed pursuant to Section 760.11(7), Florida Statutes.
Recommendation Based on the foregoing facts and conclusions of law, it is RECOMMENDED that a final order be entered dismissing with prejudice the Petition of Michelle C. Phillips in DOAH Case No. 00-1794; FCHR Case No. 98-0713. DONE AND ENTERED this 10th of July, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 10th of July, 2000. COPIES FURNISHED: Sharon Moultry, Clerk Florida Commission on Human Relations Building F, Suite 240 325 John Knox Road Tallahassee, Florida 32303-4149 Dana A. Baird, General Counsel Florida Commission on Human Relations Building F, Suite 240 325 John Knox Road Tallahassee, Florida 32303-4149 Edward R. Gay, Esquire Law Firm of Edward R. Gay, P.A. 1516 East Concord Street Orlando, Florida 32803 Richard A. Durose, Esquire Joseph W. Beatty, Esquire Foley & Lardner Post Office Box 2193 Orlando, Florida 32801-2386
Findings Of Fact Respondent graduated from the University of Havana Medical School in 1951 and practiced medicine in Cuba from that time until he immigrated to the United States in 1960. In Cuba his practice was primarily in the fields of obstetrics and gynecology. In his application dated 9 February 1975 to take the Florida Medical Examination, Respondent listed work at Hudson County Hospital for Mental Diseases (New Jersey) in 1960, work for the American Plasma Company (Miami) from 1965 to 1968, work at the Opa Locka General Hospital from 1967 to 1970, and that he was presently working as assistant doctor at 620 Southwest 1st Street, Miami. Prior to commencing this work at the Southwest Medical Clinic he contacted Physicians's Association of Clinics, Hospitals and Annex (PACHA), an organization which helps Cuban doctors obtain Florida licenses, and was told he could work at the clinic under Dr. Tomas and should register with the Board of Medical Examiners. Respondent registered with the Florida State Board of Medical Examiners as an unlicensed physician in two undated registrations, copies of which were admitted into evidence as Exhibit 5. In the earlier registration he states he is not a naturalized citizen and in the later application he states he is a naturalized citizen, although the year of naturalization is not shown. Anne West, who was apparently running an abortion referral service, called the State's Attorneys office in Miami on behalf of Respondent and was told Respondent could work at the clinic under a licensed doctor. She subsequently became Mrs. Bulas. Respondent testified he commenced doing medical work in the Miami area in 1975 when he became associated with and worked under the supervision of Kamel Tomas, M.D. in a clinic located at 620 Southwest 1st Street, Miami. He subsequently worked at this clinic under the supervision of two other licensed doctors whose names are Hernandez and Martin. In 1976 Respondent successfully passed the Florida Medical Examination and was licensed in July 1976. While working at the clinic on Southwest 1st Street Respondent performed several abortions. In an 18-count Information filed 23 March 1978 (Exhibit 1) for the period 1 May 1975 through 5 March 1976 Respondent was charged with 11 counts of unlawful practice of medicine, 6 counts of larceny and one count of unlawful termination of pregnancy. At his trial and upon the advice of counsel he pleaded nolo contendere, was found guilty of 10 counts of unlawful practice of medicine, six counts of grand larceny and one count of unlawful termination of pregnancy, and Adjudication of Guilt was withheld (Exhibit 2). Most of these charges alleged felonies. In Exhibit 3 the court stayed imposition of sentence and placed Respondent on probation for 5 years with a condition of probation that he be confined in the Dade County Jail for a term of one year. From reading the counts of the Information, as well as from the testimony of Respondent, it is clear that the larcenies alleged resulted from the fees charged by the clinic to those patients treated by Respondent, which formed the bases for the unlawful practice of medicine counts. The information alleging unlawful termination of pregnancy was based upon the performance of an abortion by Respondent while not licensed in Florida. The testimony was unrebutted that numerous clinics in Miami employ Cuban doctors who are unlicensed in Florida. In a class conducted at Jackson Memorial Hospital to prepare former Cuban doctors for the Florida examination there were about 460 in the class attended by Respondent, most of whom worked in clinics in Miami. At the time Respondent worked at the clinic he believed that so long as he was under a licensed doctor the medical work he performed was lawful. However, Respondent was not under the direct supervision of the licensed doctor as each was working on a different patient in separate examining rooms at the same time. No evidence was presented to indicate Respondent was not fully qualified by training and experience to perform the medical practices that he performed prior to receipt of his Florida license.
Findings Of Fact Petitioner Professional Firefighters of Florida, Inc. represents various public employee organizations which act as bargaining agents for firefighters employed by governmental entities in the State of Florida. In 1977, there were approximately seventy local unions with about 6,000 members, some of whom performed emergency medical services and advanced life support incident to their employment as emergency medical technicians. Petitioner Dominick Barbera is a lieutenant employed by the Dade County Fire Department and assigned to the Emergency Medical Services Division. He performs advanced life support functions in the course of his employment, but has not applied for certification as a paramedic. He testified that the challenged rules affected him in that if he did not obtain state certification, he would be relieved of his current duties which would prevent him from utilizing his training in the paramedic field and also affect him monetarily. Petitioner Gary Rainey is employed as a lieutenant with the Dade County Fire Department and performs advance life support functions on a rescue vehicle. He has not applied for state certification as a paramedic. No evidence was presented at the hearing concerning Petitioner James B. Jackson. (Testimony of Naples, Hoffman, Barbera, Rainey) Prior to the passage of Chapter 77-347, 9, Laws of Florida, (Section 401.47, Florida Statutes) there was no statutory authority for the state certification of paramedics. However, a large number of state certified emergency medical technicians were performing advanced life support functions in connection with their employment with fire departments and hospitals. These individuals had obtained training in paramedic subjects such as defibrillation, administration of intravenous solutions, intubation, and the like. The 1977 Statute was enacted to provide for state certification of paramedics who met qualifications to be established by rules promulgated by Respondent. Section 8 of Chapter 77-347 required certification of providers of advanced life support services and required such providers utilizing paramedics to employ or contract with a licensed physician "medical director" to supervise and accept responsibility for the medical performance of EMT's and paramedics. (Testimony of Westmark) In 1946, Respondent began administering voluntary examinations to those emergency medical technicians who had received training as paramedics at various places around the state. These individuals were called Emergency Medical Technicians II. Individuals who successfully passed the examination were provided a certificate that they had "demonstrated ability as an Emergency Medical Technician II by successfully completing the Florida Emergency Medical Technician II Certification Examination." In March 1977, one of Respondent's officials told a State Legislative Committee that the examinations were only "pilot" examinations to gather information to be used if legislative authority was obtained to certify individuals in the paramedic field. As a result of this information, Professional Firefighters of Florida, Inc. advised its membership that the examinations were not legally authorized, and some members did not take the examination but others did. The rules promulgated by Respondent in Chapter 10D-66, Florida Administrative Code, to implement the 1977 paramedic statute provided that those who had taken the prior examination could be certified as paramedics if otherwise qualified without any further examination. Over 1,000 of those technicians who had taken the earlier examination have since been certified as paramedics by Respondent. The subject matter, degree of difficulty, and grading system of the new certification examinations are essentially the same as the prior examination. (Testimony of Hoffman, Westmark, Rainey, Petitioners1 Exhibit 2-3, 5) The new law concerning paramedics provided that Respondent, prior to Chapter 120 public hearings on its proposed rules, consult with employees performing advanced life support services and certified by a licensed physician or local medical society, and who represented no less than nine public employers. Although petitioners testified that the firefighters belonging to their organization were not consulted in this regard even after affirmatively offering to do so by letter to the secretary of Respondent department, Respondent, in fact, conducted workshops and other meetings at various places in the state where employees representing more than nine public employers were consulted on draft proposed rules of the department. (Testimony of Naples, Hoffman, Westmark, Petitioners' Exhibit 4, Respondent's Exhibits 1-2, 4) Respondent's intent in requiring recertification of paramedics annually as set forth in Rule 10D-66.39 is to treat such a procedure as a license renewal upon payment of an annual fee. Its requirement in Rule 10D-66.41(1) concerning staffing of patient compartments of transporting vehicles by at least two qualified personnel in emergency situations is designed to provide flexibility in staffing, dependent upon the advice of a supervising physician. The requirement in Rule 10D-66.39(1)(e) concerning required age of 18 for certification as a paramedic, but still requiring one year experience as an emergency technician who also must be 18 for certification, is designed to qualify a possible candidate from another state which permits certification as an EMT at an earlier age. (Testimony of Westmark) Petitioner Barbera performs duties in advanced life support under the supervision of a hospital emergency room physician. The medical director for the Dade County Fire Department is also the director for the City of Hialeah and Santa Rosa County. He establishes the procedures to be followed by emergency medical personnel and has given group training sessions to them in the past. However, he has never given personal instructions to Petitioner Barbera with respect to actual rescue actions. Both Petitioner Barbera and Petitioner Rainey are "certified" by the Dade County Fire Department to act as a paramedic based on training in advanced life support. Rainey also works under the instructions of a physician but has never been given specific instructions on a particular case by the director. Both Petitioners testified that advanced life support cannot be administered to a patient by only one qualified individual. About sixty percent of the rescue calls received by the fire department require advanced life support procedures to be undertaken. (Testimony of Barbera, Rainey)
The Issue Whether the Petitioners have alleged facts sufficient to prove their standing to challenge the Respondent's proposed amendment to Rule 21-18.002, Florida Administrative Code?
Findings Of Fact The Florida Society of Opthalmology, Inc., Emanuel Newmark, M.D. and Waite S. Kirkconnell, M.D)., filed a Petition to Determine The Invalidity of a Rule (hereinaffter referred to as the "Petition"), with the Division of Administrative Hearing on May 29, 1990. In the Petition the Petitioners challenged the validity of a proposed amendment to Rule 21-18.002, Florida Administrative Code (hereinafter referred to as the "Rule Amendment"). The Rule Amendment was filed with the Secretary of State on March 3, 1990, with the Rule Amendment to take effect on May 7, 1990. The Rule Amendment allows licensed, certified optometrists to administer and prescribe certain Steroids and certain Steroid/Sulfonamide combinations. It is alleged in the Petition that the Petitioner, Florida Society of Ophthalmology, Inc. (hereinafter referred to as "FSO"), is: a Florida not-for-profit incorporated association of ophthalmologists, who are allopathic and osteopathic physicians, specializing in the medical diagnosis of eye diseases, anomalies and disorders, and treatment with medication, surgery, and corrective lenses and prisms. FSO acts and is organized to further the education, professional, and economic interests of Florida ophthalmologists, improve quality of health care administered to the public, and to educate the public to its needs for adequate health care. FSO routinely represents and serves its members through public relations activities, interactions with governmental agencies, and participation in administrative proceedings, legislative affairs and litigation. Pages 1 and 2 of the Petition. The following allegations concerning Dr. Newmark and Dr. Kirkconnell are included in the Petition: That Petitioner, DR. NEWMARK, is a physician licensed by the State of Florida pursuant to chapter 458, Florida Statutes. DR. NEWMARK maintains an office for the practice of medicine in Atlantis, Florida. Petitioner, DR KIRKCONNELL, is a physician licensed by the State of Florida pursuant to chapter 458, Florida Statutes. DR. KIRKCONNELL maintains an office for the practice of medicine in Tampa, Florida. Both physicians specialize in the field of ophthalmic medicine or ophthalmology. Many of these Petitioners' patients also visit optometrists for some of their vision care needs. 3. That Petitioners DR. NEWMARK and DR. KIRKCONNELL file this Petition on behalf of themselves and all other persons similarly situated; i.e., licensed Florida physicians practicing ophthalmic medicine in the State of Florida. These Petitioners also file this Petition on behalf of their patients, who are consumers of eye care and vision care services in the State of Florida. Page 2 of the Petition. The Petition contains two Counts challenging the Rule Amendment. In support of the Petitioners' standing, the following allegations are contained in Count I: That the Rule Amendment purports to authorize the practice of medicine by persons who are not licensed to practice medicine by chapters 458 and 459, Florida Statutes, thereby adversely affecting Petitioners' property right to practice medicine. That Petitioners are concerned with protection of the public by ensuring that persons engaged in the various health care professions are qualified to do so, and Petitioners believe that the Rule Amendment with illegally authorize certified optometrists to adversely affect the public health through utilization of drugs which they are not qualified to prescribe, administer or monitor. Page 5 of the Petition. In Count II of the Petition, allegations almost identical to paragraph 17 of the Petition are made. On June 13, 1990, the Intervenors filed Intervenors' Motion to Dismiss. On June 27, 1990, the Petitioners filed Petitioners' Response to Respondent's [sic] Motion to Dismiss. On June 28, 1990, the Petitioners filed Amendment to Petitioners' Response to Respondents' [sic] Motion to Dismiss correcting the title of the Motion and correction of a citation to a court decision contained in the Motion. In the Petitioners' Response to Respondent's [sic] Motion to Dismiss the Petitioners state the following: The pleadings allege adequate facts in the following paragraphs from the petition: ".... improve quality of health care administered to the public, and to educate the public to its needs for adequate health care . . . .... Many of Petitioners' patients also visit optometrists for some of their vision care needs .... .... These Petitioners also file this Petition on behalf of their patients, who are consumers of eye care and vision care services in the State of Florida. The Petitioners also quoted paragraphs 17 and 26 of their Petition. Pursuant to written notice a motion hearing was held on July 3, 1990, to consider the Intervenors' Motion to Dismiss and other motions previously filed by the parties. Following oral argument of the parties, the parties were informed that the Intervenors' Motion to Dismiss would be granted. The FSO and the individual ophthalmologists in Board of Optometry v. Society of Ophthalmology, 538 So. 2d 878 (Fla. 1st DCA 1989), cert. denied, 545 So. 2d 1367 included the following allegations of fact concerning their standing in their Petition in that case: 1. Petitioner FSO is a Florida net- for-profit incorporated association of ophthalmologists, who are allopathic and osteopathic physicians (M.D.'s and D.O.'s) specializing in the medical diagnosis of eye diseases, anomalies and disorders, and treatment with medication, surgery, and corrective lenses and prisms. FSO acts and is organized to further the education, professional, and economic interests of the Florida ophthalmologists. FSO routinely represents and serves its members through public relations activities, interactions with governmental agencies, and participation in administrative proceedings, legislative affairs and litigation. In addition to the representation of its members, FSO is committed as an organization to protecting, maintaining and improving the quality of eye care which is available to the public. 3. Petitioners Broussar, Patrowicz, and Byerly are physicians licensed by the State of Florida pursuant to Chapter 458, Fla. Stat. Broussard maintains an office for the practice of medicine in Melbourne, Florida; patrowicz in Mount Dora, Florida; and Byerly in Tallahassee, Florida. Each physician specializes in the field of ophthalmic medicine opthalmology. Ophthalmology consists of the medical diagnosis of eye diseases, anomalies and disorders, and treatment with medication, surgery and corrective lens and prisms. Many of these Petitioners' patients also visit optometrists for some of their vision care needs. . . The following allegations were included in the petition in Board of Optometry, concerning the substantial affect on the FSO and the individual opthalmologists: The physician Petitioners and a substantial number of the members of the association Petitioners are substantially affected by the Board's proposed certification of any optometrist as a certified optometrist in the following ways: Petitioners believe that the certification of optometrists, and the concomitant authorization of such certified optometrists to use and prescribe medications in their practice of optometry encroaches on the right of physicians licensed to practice medicine pursuant to Chapter 458, Fla. Stat. The right to practice medicine is a valuable property right in Florida, and subject to the protection of the due process clauses of the Florida and United States Constitutions. Petitioners have been denied due process in regard to the impending infringement on or diminution in value of their property rights. Petitioners also believe that the quality of eye care and health care available to the public will decline as optometrists are certified to use and prescribe medicine in the practice of optometry. Petitioners believe that allowing optometrists to administer and prescribe drugs presents a danger to the public, including but not limited to Petitioners' patients. Petitioners believe that the general public is uninformed as to the distinction between optometrists and ophthalmologists, when in fact significant differences exist in education, training, ability, experience, and scope of practice. The designation of some optometrists as "certified optometrists" further adds to the confusion and will result in the treatment by optometrists of patients who should be treated by Physicians. This not only will result in economic injury to physicians, including the. physician Petitioners and all other similarly situated, but also in injury to their practices, loss of public respect for their profession, and to the health and welfare of Petitioners' patients and the patients of other similarly situated physicians.
The Issue Whether there is need for a new 60-bed general acute care hospital in Seminole County? If so, to which of two applicants should a CON be awarded to construct and operate the hospital: Orlando Regional Healthcare System, Inc. (CON 9496), or Adventist Health System/Sunbelt, Inc., d/b/a Florida Hospital (CON 9497)?
Findings Of Fact The Battleground: District 7 At the heart of the conflict in this proceeding is that the two corporate combatants are the dominant providers of hospital services in major metropolitan Orlando and both are providers of very high quality acute care hospital services. Each seeks authority to construct and operate a 60-bed general acute care hospital in the fast-growing community of Oviedo, Florida. The Agency for Health Care Administration, arbiter of the conflict, has introduced a quarrel of its own by its determination that there is no need for the hospital in Oviedo, a determination with which the hospitals decidedly take issue. Oviedo is an incorporated area in east Seminole County. Seminole County, in turn, is a county that with two other counties makes a contribution by suburb or city center to the conurbation in and around Orlando, Florida's largest non-coastal city. Seminole County is also one of four counties that comprise District 7, one of eleven health service planning districts into which the Legislature has partitioned the state. See Section 408.032(5), Florida Statutes. The other three counties in the District are Orange, Osceola and, removed from the controversy in this case, Brevard. The four counties are each considered by rule of AHCA to constitute a sub-district of District 7. Brevard is Sub-district 1; Orange, sub-district 2; Seminole, sub-district 3; and, Osceola, sub-district 4. The parties consider parts of Seminole and Osceola Counties to constitute the major metropolitan area of the City of Orlando together with, of course, parts of Orange County, the county that contains incorporated Orlando. As indicated above and by its irrelevance to this proceeding, no part of Brevard County is considered by the parties to make up any of metropolitan Orlando. There is also one county outside District 7 about which the parties introduced evidence, Lake County in District 3. Nonetheless, District 7 remains the primary battleground with a focus on sub-district 3 as the site of the CON sought by the parties. The Parties AHCA The Agency for Health Care Administration is the state agency responsible for the administration of the CON program in Florida pursuant to the Health Facility and Services Development Act, Sections 408.031-408.045, Florida Statutes. ORHS One of the two dominant health care providers in the Orlando area, Orlando Regional Healthcare System, Inc., is a Florida not-for-profit corporation that owns and operates eight facilities in the four-county area of Orange, Seminole, Osceola and Lake Counties, "the only market" (tr. 22) that it serves. Half of ORHS's facilities are in Orange County. These four facilities are: Orlando Regional Medical Center, a 517-bed general acute care hospital that provides tertiary services in addition to routine acute care hospital services and that is the site of a trauma center; Arnold Palmer Hospital for Children and Women, a 281-bed specialty hospital that provides women's and children's services including neonatal services; Orlando Regional Sand Lake Hospital, a 153-bed general acute care facility that provides comprehensive medical rehabilitation services; and Orlando Regional Lucerne Hospital, a 267-bed general acute care hospital that provides comprehensive medical rehabilitation and skilled nursing unit services. In Seminole County, ORHS wholly owns and operates Orlando Regional South Seminole Hospital ("South Seminole"), a 206-bed general acute care facility that provides adult/child psychiatric and adult substance abuse services as well as general acute care services. In Osceola County, ORHS owns Orlando Regional St. Cloud Hospital, an 84-bed general acute care facility. In Lake County, ORHS jointly owns and operates two health care facilities under joint venture business arrangements: South Lake Hospital, a 68-bed general acute care facility and Leesburg Regional Medical Center, a 294-bed general acute care facility. The wholly owned facilities operate under a single license and are accredited by the Joint Commission on Accreditation of Health Care Organizations ("JCAHO"). One of six statutory teaching hospitals in the state, ORHS has been in continuous existence since 1918. Its mission is to be a local, unaffiliated health care provider, providing health care services to the citizens of Central Florida. Recognized as one of the top 100 hospitals in the United States by US News and World Report, ORHS has been the recipient of numerous awards and recognitions. As but one example, it was the winner of a Consumer Choice Award from the National Research Corporation for the years 1999 through 2001. Orlando Regional Healthcare System provides outstanding health care of the highest quality to patients at its eight facilities in three of the four counties in AHCA's Health Care Planning District 7. Florida Hospital The other dominant health care provider in the Orlando area is Florida Hospital. Founded as a sanitarium, Florida Hospital has been in existence and a presence in the Orlando medical community since 1908. Florida Hospital is part of the Adventist Health System, a not-for-profit hospital organization that operates hospitals throughout the country. In the Orlando area, Florida Hospital has seven acute care campus systems operated under a single license in a three- county area: Orange, Seminole and Osceola Counties. The original and main campus is located in downtown Orlando. A second campus is in East Orlando. The five other facilities are in Altamonte Springs, to the northwest of Orlando; Apopka, further northwest; Winter Park, just north of Orlando; and Celebration and Kissimmee, both southwest of the city. Florida Hospital also operates Florida Hospital Waterman under a separate license in Lake County in District 3. The seven campuses in District 7 are unified by more than just licensure. Consistent with their operation under a single license, all seven operate under a single provider number with Medicare/Medicaid. They have a single medical staff and a single accreditation with JCAHO. The seven Florida Hospital campuses operate under a single leadership structure; all policies, procedures and matters that pertain to the operation of the hospital are part of the single body of operational guidelines and procedures that are provided by the organization. The seven campuses also operate under a single price structure, a single charge master that runs across the entire organization. The goal of operating the seven campuses in a unified manner is to maintain continuity and promote one standard of care so that when a patient enters any of the facilities, the patient can rely on receiving the same high standard of care as would be received at any other Florida Hospital facility. Operation under a single structure also provides a patient with the coverage of physicians and staff throughout the system to cover any and all needs of the patient. From its inception, the mission of Florida Hospital has been to extend a religious ministry of healing to the community consistent with Adventist principles. Among these principles are awareness of the eternal nature of the moment at which care is extended to the patient as well as recognition of each patient as a child of God, entitled to the highest possible quality of care embodied in "whole person health" (tr. 876) composed of physical, mental and spiritual well-being. Florida Hospital carries out its mission with "a strong sense of stewardship for providing care in the communities that [the hospital] serve[s] . . . ." (Tr. 875). The success of Florida Hospital's philosophy of care is evident in recognition bestowed by others. For example, Florida Hospital was recognized as being among the top 50 hospitals in the country for nine specialties in the July 2002 edition of U.S. News & World Report's "America's Best Hospitals." To take but one of the nine, "Heart & Heart Surgery," Florida Hospital is ranked 12th in the nation in the company of those ranked just above: Cleveland Clinic, Mayo Clinic (Rochester), Massachusetts General, Brigham and Women's Hospital, Duke University Medical Center, Johns Hopkins, Texas Heart Institute-St. Luke's in Houston, Emory University Hospital, Stanford University Hospital, Barnes-Jewish Hospital in St. Louis and the UCLA Medical Center. Well-Matched Applicants In its state agency action report ("SAAR"), AHCA noted that ORHS and Florida Hospital are two large, well-matched hospital systems. Both operate over 1,500 beds in the Orlando area. Both generate approximately two billion dollars of gross charges annually. Both deliver over 300,000 patient days of patient care. Together, they are the overwhelmingly dominant providers of health care in the major metropolitan Orlando area. In the SAAR, the Agency discussed distinctions between the two applicants. Had AHCA determined that there was need for the facility, it would have had a difficult time deciding which corporation should be awarded the CON. None of the distinctions between the two were found by AHCA to be substantial enough to serve as a basis for choosing either applicant over the other. Other District 7 Hospitals Besides the two applicants, the dominant providers of hospital services in District 7 by virtue of number of facilities (13 hospitals in the District and three hospitals in Lake County immediately adjacent to the District), among other reasons, there are three other hospitals in the District. Health Central is a hospital operated by a statutorily created tax district in the City of Ocoee, in Orange County. Central Florida Regional Hospital is owned and operated by Hospital Corporation of America ("HCA") located in the City of Sanford in Seminole County. It is approximately 14 miles from the proposed locations of the applicant's facilities. Osceola Regional Medical Center, another HCA facility, is located in Kissimmee in Osceola County, not far from Florida Hospital's Kissimmee and Celebration facilities. Stipulation The parties stipulated to the following: The applicable fixed-need is zero. Both applications complied with the requirements of Sections 408.037, 408.038 and Subsections (1), (2) and (3) of Section 408.039, Florida Statutes, and the requirements of Rules 59C-1.008 and 59C-1.010, Florida Administrative Code. Both applications meet the review criteria contained in Subsections 408.035 (3),(6),(8),(10) and (11), Florida Statutes and the review criteria in Subsections 408.035(4),(5) and (12), Florida Statutes, are not applicable in this case. The statutory review criteria at issue in this case are Subsections 408.035(1), (2), (7) and (9), Florida Statutes. Numeric Need Numeric need for general acute care beds is determined pursuant to Agency rule, Rule 59C-1.038, Florida Administrative Code. The rule's methodology for the calculation of numeric need for general acute care beds is by sub-district. Since "there really is no longer a future projection methodology in the rule . . . it was stricken out two or three years ago," Gene Nelson, one of ORHS' experts in health planning, refers to the rule as containing a "retrospective occupancy model." (Tr. 619). Under the methodology, additional beds are not normally approved in any sub-district where historic occupancy is less than 75%. If occupancy exceeds 75%, beds will be awarded to bring occupancy down to 75%. In other words, instead of projecting forward as it once did to determine need, the rule looks back to occupancy. If occupancy in the sub- district has met the threshold, then positive numeric need is established. Criticism has been leveled at the methodology. Not taking into account future population growth or occupancy rates at times other than midnight, are but two examples. Criticism, however, of the rule is of little moment in this case since the case is a challenge to agency action not to the rule that contains the methodology. Whatever the appropriateness or validity of the criticism, the calculations pursuant to the methodology have not yielded a fixed-need pool above zero for any of the many sub- districts in the eleven districts of the state for some years now. Nor is numeric need for general acute care beds expected by the Agency to exceed zero anywhere in the state for the foreseeable future. During this time of numeric need "drought," AHCA, nonetheless has awarded CONs for new general acute care beds and even new hospitals on a number of occasions. For example, "[d]espite the fact that there was an applicant proposing to relocate beds within the subdistrict, which wouldn't have affected the bed inventory at all, the state elected to approve [another] applicant . . . that applied for a brand-new 60 bed hospital" (tr. 635) in the community of Lady Lake in District 3. The application in that instance had been filed in the fall of 1998. In a second example, in the fall of 2001, a few years later, Osceola Regional and Florida Hospital Celebration were each approved to add beds to existing facilities despite the fact that there was no numeric need and the hospitals did not meet the statutory occupancy levels for additional beds. Mr. Nelson also testified about a third recent example where a new hospital was built when the subdistrict occupancy was low, the facts of which compare favorably, in his view, with the facts in this case. As he tells it, these three cases, compared to this case, produce inconsistency: In the fall of 1999, Sacred Heart Hospital applied to build a new 60-bed hospital in the southern portion of Walton County. That particular subdistrict is actually a two-county subdistrict consisting of Okaloosa and Walton counties, has some existing hospitals, current subdistrict occupancy in that area is 56.3 percent. Despite . . . the low occupancy . . . the state recognized the validity of the arguments about a growing population, about accessibility, many of the same issues that you have here and approved Sacred Heart to build a new 60-bed hospital in that location. * * * I am not criticizing any of these approvals. I . . . am criticizing [that the state was] presented with a similar set of circumstances in this case [and] the applications were all denied. And I think there is an inconsistency here. (Tr. 637-8). During the same period, moreover, beds have been added to existing hospitals without CON review, accomplished by way of Section 408.036(n), Florida Statutes. The statute allows 10 beds or 10% of licensed bed capacity to be added to a hospital's acute bed inventory upon certification "that the prior 12-month average occupancy rate for the category of licensed beds being expanded at the facility meets or exceeds 80% . . . ." Section 408.036(n)(1)a., Florida Statutes. See also Rule 59C-1.038(5), Florida Administrative Code. The bed additions made with and without CON review contribute to current numeric need determinations of "zero" and the continued reasonable expectation that AHCA's methodology for determining acute care bed numeric need will not yield numeric need in excess of zero for years to come. Most pertinently to this case, these additions erode AHCA's position advanced in hearing in this case for a preference to keep open the option for a future competitor, a competitor other than one of the two dominant providers, presumably when numeric need has been determined to exist, a condition not likely to come into play for the foreseeable future. However the future plays itself out and the effect on AHCA's current methodology, there remains one point central to consideration in this case. In light of a numeric need of "zero" for the applicable batching cycle, for a CON to be awarded as a result of this proceeding, as a first step, the applicants must demonstrate the existence of "not normal" circumstances that support an award. The two applicants attempt that step in tandem. Both ORHS and Florida Hospital contend that rapid population growth, problems of access to acute care and emergency services in the Oveido area, and mal-distribution of beds in the sub-district and district constitute circumstances that justify need for their proposed facilities. In other words, they are "not normal" circumstances. Not Normal Circumstances - Population Growth A rural farm community not long ago with a population of about 7,500, the City of Oviedo, in the last 15 years, has grown into an Orlando bedroom community. The population increase within the city limits is proof of the city's metamorphosis from countryside to suburb. During this period of time, the municipal population has nearly quadrupled to 28,000 with no end in sight to continued growth in the area as explained by ORHS' expert, Dr. Rond: The special circumstances . . . that drive this application are, first, the unprecedented population growth. As we have seen, we are experiencing population growth in excess of a hundred percent in the east Seminole area. In the adjacent Winter Springs area, we are experiencing a rate in excess of 51 percent. We are talking about a population that is going to reach almost 200,000 people by the year 2006. (Tr. 377-8). The area is projected for an additional 18.2% growth by 2006, when as testified to by Dr. Rond, the population will reach nearly 200,000. The municipal population is not the only population of a political entity in the area to quadruple in modern memory. Over the past three decades Seminole County has grown fourfold - from 83,692 in 1970 to 365,196 in 2000. As a result, the county is the third most densely populated of the state's 67 counties. Until the mid-1990's, population growth was concentrated in the western half of the county as Orlando area development spread north into Seminole County along the I-4 and U.S. Highway 17/92 corridors. Since then the rate of population growth has been dramatic in east Seminole County in part because of the opening of another major transportation corridor, the "Greenway," Highway 417. Between 1990 and 2001, east Seminole County more than doubled in size (24,840 to 51,287; a 107% increase) while West Seminole grew by only 22%. East Seminole County is expected to remain the fastest growing portion of the county into the foreseeable future. With approximately 43% of the total land area of the county but only about 16% of the population, it remains much less densely populated than the remainder of the county, affording greater opportunities for future growth. Seminole County is unique in the state from the perspective of bed-to-population ratios. The three hospitals in Seminole County with a combined total of 575 licensed beds, yield a ratio of 1.55 beds per 1,000 population; tied for lowest bed to population ratio of the sub-districts in the state. The only area with a comparable ratio is Sub-district 8-4, comprised of Glades and Hendry Counties, located southwest of Lake Okeechobee, "a very rural area." (Tr. 625). While these two sub-districts are similar in bed to population ratio, they are at opposite extremes in terms of population density. The population of Seminole County, at 371,000 is nearly nine times the combined populations of Glades and Hendry Counties at slightly more than 42,000. Sub-district 8-4 is "totally unlike Seminole County from the standpoint of population demographics; and yet in terms of resource availability, . . . it has a comparable amount of resources per thousand population." (Id.) Thus, Seminole County occupies a unique place in the state for its low bed-to- population ratio considering its overall population. Population forecasts for the next five-year period support the expectation of continued strong growth in east Seminole County. For example, the downtown area of Oviedo plans a residential area with a density up to 50 dwellings per acre, at least one of the highest in the County. In the City of Oviedo vicinity, median densities are increasing from 4 homes per acre to 10, to allow for townhouses. East Seminole County is reasonably expected to have 60,597 residents by the year 2006, an 18.2% increase over 2001. By comparison, West Seminole County is expected to experience only a 6.3% rate of growth. Projected growth in the City of Oviedo, moreover, is in all likelihood understated due to significant residential developments currently underway that alone are expected to add up to 6,238 new residents to the city's population. One need only look to actual growth in the area for support for such a prediction. Actual growth has consistently outpaced projected growth governed by methodologies that have repeatedly failed to reflect the reality of population growth in Oviedo. Related to population growth are utilization projections by the applicants' health planning experts for an Oviedo hospital. Judy Horowitz, Florida Hospital's expert health care planner, explained Florida Hospital's: [W]e looked at historically what had come out of the service area as we defined it. We projected that that volume would grow in proportion to population growth. We looked at a subset of services, those that were likely to be provided at a community hospital as was being proposed by Florida Hospital Oviedo. We looked at what we thought a reasonable market share would be; and our overall forecast is that within two years of opening this facility, that we would reach 77 percent occupancy at a 60-bed facility. So our year two, which is the 12 months ending June of 2007, . . . . we would already be at 77 percent occupancy. Then our first year we would be at approximately 68 percent occupancy. * * * [T]here is clearly sufficient demand to support the hospital as proposed; and the fact that we are projecting a relatively high utilization very quickly shows the magnitude of that demand. (Tr. 1352, 1353). With the high level of population growth and the demand for hospital services that such growth generates, the citizens of Oviedo expect access to hospital care within the community. In keeping with citizen expectation, the City of Oviedo has adopted a resolution that urges AHCA to approve a new hospital in the Oviedo community. It has been joined in its resolve by the Board of County Commissioners for Seminole County through a resolution of its own. To underscore the force of the two resolutions, the corporate parties presented the testimony of representatives of both the City Council and the County Commission. Grant Malloy, the County Commissioner for County District I who grew up in the area with fond childhood memories of "being overcome by the orange blossom smells, they were so intense," (tr. 802) described the growth observed first-hand by him during his lifetime as "phenomenal." (Tr. 806). In answer to the question whether his constituents would benefit by a new 60-bed hospital, Commissioner Malloy testified I do believe so. There is . . . the growth that's occurring there. And I heard . . . discussion about getting to some of the other hospitals. And once you get out of Seminole County . . . the roads are very, very difficult to travel on especially getting into Orlando. Especially rush hour . . . . . . . [T]he growth . . . would support such a facility. I know our board passed a resolution, along with the City of Oviedo[.] [O]ur board, and all the commissioners are unanimously supportive of a hospital in the area. I haven't heard from any residents or constituents that have said it was a bad idea. . . . [P]eople are pretty excited about it. (Tr. 807-8). Tom O'Hanlon, Chairman of the City Council, in the company of three other members of the council, unequivocally backed up Commissioner Malloy's appeal for a new hospital. The changes he has seen in Oviedo, he described as: Dramatic changes. When I moved there, [Oviedo] was a very rural area, and it is no longer . . .; it’s a highly compacted urban area. [W]e are working on a new master plan for downtown, which will have higher densities than we have in our city today. (Tr. 812). Chairman O'Hanlon went on to describe how the pace of the growth continuously outstrips population projections that are the product of the City's best efforts to follow appropriate methodologies for making such projections: [T]he city continually makes population projections. I have always been involved with them[.] [T]here are guidelines . . .; and everytime we make them, the city grows far in excess of th[e] projections. The area is such a dynamic area because we have got the University of Central Florida there, which is just growing as fast as the city is, maybe even faster. You have the Research Park there and you have got excellent schools. And for that combination . . . everybody wants to move there. (Tr. 812-3). The university is just south of the city limits. It has minimal dormitory facilities on campus. The result is that "a vast majority [of students] live off campus in housing and apartments [and they are impacting all the services that must be provided in Oviedo.]" (Tr. 814). Following this testimony of Chairman O'Hanlon, the following colloquy ensued between him and counsel for ORHS: Q Is it fair to say, Councilman O'Hanlon, that the City of Oviedo and surrounding area is in growing urban area that has everything but a hospital? A That is a true statement. Q Are you familiar, Councilman O'Hanlon, with the proposals of Orlando Regional Healthcare System and Florida Hospital to locate a 60-bed hospital in the City of Oviedo? A Yes. Q Do you support that effort? A A hundred percent. Q Do you believe, Councilman O'Hanlon, it would be of benefit to your constituents to have that [hospital] in the city of Oviedo? A Absolutely. People approach me every week wanting to know where our hospital is. Q Can't understand why it's not there already?A Well what they understand is that there is a tremendous need for a hospital and they don't understand why it's not in the process. (Tr 816-7). Residents of Oviedo also do not understand why they have to drive for such a long time to reach a hospital particularly when their goal is the emergency department. This concern about which Councilman O'Hanlon hears from a constituent "at least once a month" (tr. 819) also made its way into the resolutions of the two political bodies in the form of an identical introductory clause, as follows: "WHEREAS, there are increasing problems with timely access to care especially for emergencies," (Joint ORHS/Florida Hospital Nos. 8 and 10). It is, moreover, a concern that takes up the second prong of the applicants' case for "not normal" circumstances: issues of access. - Access The Oviedo Service Area Although similarities exist between the two, the Oviedo Service Areas defined by the two applicants are somewhat different. The service area selected by ORHS is larger than the service area selected by Florida Hospital. The Primary Service Area ("PSA") for ORHS' proposed hospital is composed of four zip codes: 32765, 32732, 32766, and 32708. Of the four, the first three are in eastern Seminole County, that is, east of Highway 417, the Greenway, and south of Lake Jessup. The fourth, 32708 in the Winter Springs area, is just west of the Greenway. The Winter Springs zip code was included in ORHS' PSA in part because it is adjacent to the Greenway. It has also experienced tremendous population growth and is very close to the proposed site for ORHS' hospital. A secondary service area proposed by ORHS is composed of a zip code in Seminole County north of Lake Jessup, 32773, and three zip codes in Orange County, 32817, 32820, and 32826. Located in the midst of the three Orange County zip codes is zip code 32816. It appears on ORHS exhibits as part of the secondary service area. As the zip code for the University of Central Florida, it has a very low residential population so that there are only a few students who might live in a dorm that would list it as their residence when receiving hospital services. There are actually "very few" (tr. 302) discharges from zip code 32816. If one does not include zip code 32816 then ORHS' service area is a comprised of eight zip codes. The April 1, 2001, population for the primary and secondary service areas or the service area designated by ORHS is 170,774. This service area has more than doubled in population over the last decade. Over the next five years, the service area is expected to reach 193,408 residents, of which 45% will be of prime child bearing age (15-44), "a dominant position for that age cohort within the population." (Tr. 315). The Oviedo service area is defined by Florida Hospital as four zip codes in Seminole County, 32708, 32732, 32765, and 32766 and one in Orange County: 32826 (all zip codes in ORHS' service area) with a population of more than 100,000. Florida Hospital's service area does not include Zip Code 32773 (the zip code north of Lake Jessup) that is in ORHS' service area nor, with the exception of 32826, does it include any of the Orange County zip codes that are in ORHS' service area. Thus, there are five zip codes in what Florida Hospital regards as the Oviedo Service Area and eight in what ORHS regards as the Oviedo Service Area if zip code 32816 is excluded. Although somewhat different, for purposes of examining travel distance and time between Oviedo and area hospitals, the Oviedo Service Areas of the two applicants are similar enough to be considered to be the same. Or, as William E. Tipton, an expert in traffic transportation and civil engineering, testified at hearing, the results of his study entitled "Travel Time Analysis Proposed ORHS Oviedo Campus, Oviedo, Florida" (ORHS Ex. 14) would not be substantially different if he had focused on the Florida Hospital site instead of the ORHS site. Travel Time Analysis Mr. Tipton prepared a travel time analysis to evaluate the differences in travel time that could be anticipated with the development of a hospital campus in Oviedo. Mr. Tipton's study concluded that there would be a reduction of average daily travel time from the ORHS PSA to a hospital by 64% or 18 minutes. The maximum reduction will be 75% of the time or 21 minutes. In the critical peak afternoon hour, there will be a maximum reduction of 79% or 22 minutes in time from that which exists today. The reductions in drive distance for Oviedo area residents if a hospital were in Oviedo would be significant especially in the arena of emergency services. Emergency Services Access to emergency services at a hospital emergency department ("ED") is one of the most important factors in making sure people have reasonable access to community hospitals. "[Y]ou really need . . . immediate care for emergencies, and so it's important to be able to get to the emergency department quickly and to receive care rapidly once you get there." (Tr. 336). Between 1997 and 2001, the hospitals experiencing the highest percentage of ED visit increase, other than Health Central, were Florida Hospital East in Orange County and South Seminole Hospital in Seminole County. During the period between 1997 and 2001, although the population of Seminole County grew less than Orange County, Seminole County had a larger percentage of ED visits. Specifically, the population of Seminole County grew 12% but its ED visits increased 23%, twice its population growth. During the same period, the population of Orange County grew by 15% but its ED visits only increased by 17%. Closer examination of these statistics reveals that ED visits in the downtown area of Orlando, to include Orlando Regional Medical Center and Florida Hospital, were below the county average. However, suburban hospitals, or those in outlying areas, particularly near Oviedo, had much greater ED visit growth: ED visits grew 27% at Florida Hospital Apopka and 37% at Florida Hospital East. Florida Hospital East is the closest hospital in Orange County to the Oviedo area. Of the hospitals in Seminole County, South Seminole was the most severely affected by ED visit increase with a 38% increase of ED visits between 1997 and 2001. (ED visits in excess of 27,000 by area residents are projected in 2006.) In the Oviedo area there are unfortunate but not uncommon delays in emergency transport. More than 20% of emergency transports involve delays of in excess of 45 minutes after arrival at the hospital. These delays are serious because patient outcomes decline dramatically if definitive care is not delivered within the "golden hour," a concept that: reflects the fact that patient outcomes decline [dra]matically in terms of . . . mortality rates if definitive care is not delivered within one hour of the traumatic injury that has been sustained. In cardiology, they tend to . . . say "time is muscle," * * * the longer it takes for a patient to get definitive care following a major cardiovascular event, the more muscle mass is likely to be damaged. . . . [Y]ou can go on and talk about stroke victims, cerebral vascular patients and just a whole array of patients who [fare] much better in terms of morbidity and mortality if they receive definitive care within an hour of the episode. (Tr. 336). Part of the delay for patients in need of prompt emergency services is due to ambulance standing time. Standing time is the time a patient waits in the ambulance or hallway of the emergency department before the patient is seen by medical staff. This standing time does not include the time it takes the ambulance to respond to the call or the time the EMS personnel spend at the scene to stabilize the patient. Nor does it include the travel time to the hospital from the scene. Ambulance standing time for patients from the Oviedo area on average is between 42 and 47 minutes. When average travel times established in Mr. Tipton's study are combined with the standing times, there is not one existing provider of emergency services that can provide a patient from Florida Hospital's Oviedo Service Area or ORHS' PSA with emergency care within the "golden hour." This combination, moreover, as stated above, does not take into account the dispatch time and time of the ambulance at the scene. The typical types of emergency calls EMS personnel see in Oviedo include difficulty breathing, auto accidents, kids falling off bicycles, heart attacks, and drug overdoses. The largest majority of calls would go to a local community hospital as opposed to trauma center in downtown Orlando. Jeffrey M. Gregg, Chief of the Bureau of Health Facility Regulation, which includes the Certificate of Need Program for the Agency for Health Care Administration, testified that emergency room access is a problem that has gotten worse over time. Mr. Gregg also stated that a new hospital in the area will improve emergency access for people in the immediate area. A new hospital in Oviedo service area would also benefit and improve emergency access for patients in Orange County emergency rooms by lessening the emergency patient loads they experience. Wayne Martin, Fire Chief, Emergency Management Director, City of Oviedo, testified that the standing times and delays at the area hospital emergency rooms tie up Oviedo area ambulance services for an extended period of time. Emergency Medical Service ("EMS") staff must stay with their patient until the patient is taken into the emergency room and given medical care by emergency department staff. Because of these delays, EMS staff are out of their service area for extended periods of time. This decreases the level of service for the residents of the Oviedo area. One aspect of the problem influences another so as to create a compounding effect. Dr. Robert A. Schamberger, a family practitioner in Oviedo, testified that recently a patient went to the emergency room at an area hospital and it took 16 hours from the times she arrived until she was seen by the emergency room personnel. Dr. Schamberger tried to admit another patient of his in an area hospital on a recent Friday and was informed there were no beds. The hospital said they would call when they had an available bed. The patient was finally admitted on Monday. Emergency room waiting times across the entire community are several hours, which is an unacceptable care standard. Dr. Zulma Cintron practices internal medicine in Oviedo. Dr. Cintron testified that there is a "huge need" for a hospital in the Oviedo area. "We definitely need the beds." Dr. Cintron has had patients with chest pains who ended up waiting in the emergency room for four, five, and six hours before receiving care. Patients with less imminent needs have waited 12, 16 even 24 hours. Dr. Cintron's testimony for Florida Hospital was confirmed by the testimony produced by ORHS of Scott Greenwood, M.D., a cardiologist who heads a cardiology group. The evidence provided by Drs. Schamberger, Cintron And Greenwood, anecdotal though it may be, supports the existence of a problem with emergency services access in the Oviedo area that is shown by the analysis provided by the combination of Mr. Tipton's traffic study and ambulance standing time. So does projected volume for ED visits. Projected volume at Florida Hospital Oviedo in year two would be in excess of 27,000 visits. The Oviedo area has a population that "is adequate to support a hospital at high utilization levels within [a] short period of time and also will generate a significant number of emergency visits." (Tr. 1355). A new hospital facility in the Oviedo service area would help to alleviate the delays currently being experienced in the area hospital emergency departments. The Agency is not unaware of the problem and the solution that an Oviedo hospital would provide. The issue for AHCA is "[w]ould the improvement that would result for some people justify the construction of an new hospital?" (Tr. 726). The applicants claim that the three existing Seminole County hospitals are not appropriately located to provide emergency services required by the growing population of Oviedo. Put another way, within the sub-district and District 7, ORHS and Florida Hospital assert there is a mal-distribution of beds. Mal-distribution of Beds While population growth has increased dramatically in east Seminole the opening of health care facilities in the east part of the county has lagged behind; the area has more than 100,000 people but no hospital. The three acute care hospitals in Subdistrict 7-4 are all located in the western portion of Seminole County. People tend to use hospitals closest to them especially for emergency services. Because of the north/south nature of the road corridors in Seminole County and the congestion and distances involved in east/west travel in the county, the Oviedo area population's access to existing hospital service in the district is problematic. The population has better access to resources in Orange County, a different subdistrict, and, in fact, 66% of the Oviedo population take advantage of that better access. Consistent with the pattern of transportation development in Seminole County, all three hospitals in Seminole County are located between I-4 and U.S. Highway 17-92. Florida Hospital Altamonte is situated along the 436 corridor, whereas South Seminole Hospital is located further to the north on State Road 434, while Central Florida Regional Hospital is situated at the northern border of the county along the U.S. Highway 17-92 corridor. Dr. Rond had this to say about the locations of the three Seminole County hospitals in relation to the population in east Seminole County: The resources in the western part of the county are not situated in such a way that they are being utilized effectively by residents of [ORHS'] service area. Instead, they seek to move along the north/south corridor, primarily the Greenway, to utilize the services located in Orange County or … they take other routes of access to reach Winter Park Hospital, which is . . . in Orange County. (Tr. 319). The problem of distribution of hospitals is not restricted simply to inside the county. There is a mal- distribution in District 7 as well. Overall in the district, there are 2.3 beds per thousand. Orange County enjoys a ratio that is very high when compared to Seminole County's. Orange County's bed to population ratio is 2.7 beds per thousand, whereas Seminole County's is only 1.55 beds per thousand. The average bed ratio in Florida is 2.85 per thousand. Whether measured against the state ratio or the Orange County ratio, general acute care hospital beds per thousand population in Seminole County is low. The ratio comparison between Orange County and Seminole County will improve with an Oviedo Hospital although it makes the overall ratio only "a little closer; so that Orange County has beds per thousand and Seminole County would have 1.6 beds per thousand." (Tr. 316). The applicants intend to make that improvement with their proposed projects. The Proposed Projects ORHS' Orlando Regional proposes to construct a new 60-bed acute care hospital in the City of Oviedo. The location was described at hearing by Karl W. Hodges, ORHS vice president of Business Development: [T]he hospital [will be built] within a two- mile radius of . . . Highway 426, also called Loma and Mitchell Hammock Road which is also called Red Bug Road. [The CON Application] further stipulates we'll be east of 417. (Tr. 20). Within that area, ORHS proposes to build a three-story 155,000 square foot facility on approximately 35 acres of land. Although a site has not yet been purchased, there is at least one parcel of 35 acres of land available in the area that can be acquired by ORHS at a price of $7,000,000 or less, as indicated in its application. The bed complement of the proposed facility will be eight ICU beds, ten labor-delivery-recovery and post-partum ("LDRP") beds serving the obstetrics department, 15 telemetry monitored beds, and 27 medical/surgical acute care beds. The proposal will add 30 beds to the inventory of beds in the sub-district but it will not add beds to the inventory of District 7. The 60 beds will be transferred by ORHS from two facilities. Thirty of the beds will come from South Seminole Hospital (in Seminole County). By itself, moving the 30 beds within the sub-district "for the stated goal of enhancing access . . . is a non-controversial project" (tr. 627) that is not subject to a certificate of need methodology but that still requires CON review and approval. The other thirty beds will come from Orlando Regional Lucerne Hospital in Orange County. However attractive for its minimization of controversy, all 60 beds could not have been transferred from South Seminole because to do so would have raised its occupancy above 80%, "an untenable result." (Tr. 630). For the additional 30 beds, "Lucerne seemed like a logical choice, given its bed size and its utilization." (Tr. 628). The design of the proposed hospital is based on another ORHS facility: South Lake Hospital, a replacement facility that opened in January of 2000. Florida Hospital's Florida Hospital also proposes to construct a 60-bed acute care hospital in the City of Oviedo. Unlike ORHS, Florida Hospital owns the site, 15 acres at 8000 Red Bug Lake Road near an intersection with the Greenway. The site currently includes a two-story, 41,000 square foot medical office building and a one- story, 6,000 square foot urgent care center. A two-story, 161,000 square foot facility is proposed to be constructed on the remaining vacant space at the site that has been approved under the Development of Regional Impact process for a 120-bed hospital. Ownership of a DRI-approved site will save Florida Hospital time and expense entailed by permitting requirements. All 60 beds will be part of an innovative design referred to as a "universal room and universal care delivery model." For the present, Florida Hospital does not intend to provide obstetrics at the Oviedo facility but "all of the universal patient rooms are capable of being LDRP rooms" (tr. 1181) should Florida Hospital decide in the future to provide obstetric services at the hospital. Florida Hospital will transfer 60 beds from Orange County facilities so that Florida Hospital's proposal will increase the sub-district's bed inventory by 60 beds, 30 more than the increase that will be affected by ORHS' proposal. Just as with ORHS, Florida Hospital's proposal will not increase the bed inventory in District 7. Fifty beds will be transferred from Florida Hospital's Winter Park facility and 10 beds will transferred from Florida Hospital's Apopka facility. AHCA's View of the Proposals The Agency's conclusion that the applications did not demonstrate "not normal" circumstances was reached with difficulty. Review of the applications taxed the agency's decision-making process because of the challenging circumstances presented by the applicants. As Jeffrey Gregg testified for the Agency, when there is "no fixed-need pool," AHCA look[s] at applicants in terms of a unique set of circumstances that they present . . . and in this instance, The circumstances . . . in this case challenge the system, make it more difficult for [the Agency] to make a sound decision in the tradition of the CON program. (Tr. 723). However much in keeping or not with the tradition of the CON program, the determination that there were no "not normal" circumstances to justify need afforded a benefit to the Agency; it would not have to make the difficult choice between the applications. While it could have granted both applications, an option considered by the Agency (see tr. 729), no party contended in this proceeding that circumstances justify two new 60-bed hospitals in Oviedo. If need is proven for but one hospital, then a selection must be made. Yet, at every turn, AHCA has found one advantage held by an applicant to be defeated by another held by its opponent or one set of circumstances that would normally be an advantage neutralized by other considerations. For example, in view of the nature of the Orlando market, AHCA reasonably did not give much weight to ORHS' proposal to add fewer beds than Florida Hospital to the sub- district despite the fact that usually there would be advantage to a mere intra-sub-district move. In the absence of fixed need, for example, such a move would not have to be supported by "not normal" circumstances. To the contrary, however, from the point of view of practicality, it makes more sense "to take beds from a more urban setting [in Orange County, a different sub-district] where they are not being used [as proposed by Florida Hospital] and move them to a new rapidly growing area where there are not hospital beds." (Tr. 739). A sense of practicality guided AHCA throughout its CON review in this case. The Agency, in fact, approached the applications by "trying to be as practical as possible." (Id.) As explained by Mr. Gregg, again on behalf of AHCA: [The Agency] do[es] not give much weight to the fact that [the applicants] would be crossing subdistrict lines here and that one of them [ORHS] is in a position to . . . add fewer beds to the planning area. That's noted in the SAAR, but practically speaking, we are talking about a metropolitan area here. We are talking about in both cases large systems wanting to move beds from one part of their system to another part. So in many ways, . . . once again, [ORHS and Florida Hospital] are really well-matched and difficult to distinguish. (Tr. 724, emphasis supplied). The difficulty inherent in distinguishing between the applicants was repeatedly emphasized by the Agency. The point was brought home once more in questioning of Mr. Gregg by counsel at hearing: Q [W]ith regard to the minute distinctions between the applicants, at your deposition, some of the statements you made in that regard included [that ORHS and Florida Hospital] are both good citizens. All of these things in this case, coming up so close and so equal, that . . . in terms of CON analysis, it becomes very difficult . . . to make a distinction between the two of them. They are both just that good. And then also [the Agency] think[s] they compare very favorably, and very evenly, noting again and again and again that they are very, very close, very, very comparable. Is that still your position here today? A Yes. (Tr. 766-7). However close the Agency regards the two, there are differences in the applications. While some may not be of great benefit to a decision, others may serve to sustain a principled choice. Differences in the Applications Obstetrics The leading reason for hospitalization among area residents is the need for obstetrical services with births running at more than 2,000 per year. During the 12-month period ending June 2000, for example, childbirths accounted for 2,041 discharges. Of the top ten DRGs for discharges among area residents, uncomplicated vaginal delivery accounts for the most discharges, cesarean section ranks third and vaginal delivery with complications is seventh. In keeping with the demand for obstetrical services, the utilization patterns of the population in the Oviedo Service Area and the area's age composition, upon the opening of its facility, ORHS proposes to provide obstetrical services. The proposal is also due, in part, in response to the closing of the obstetric program at Florida Hospital East in May of 2001. There is physician support for ORHS' proposed obstetric services. Robert Bowles, M.D., testified by deposition that his group practice, Physician Associates of Florida, comprised of 14 obstetricians and gynecologists would cover obstetrics at an Oviedo hospital. While Dr. Bowles would not personally admit obstetrics patients at the new hospital, three of his partners would. Florida Hospital does not propose to provide obstetrics upon opening although it has designed its physical plant to provide an OB unit so that Florida Hospital would have the capability of initiating that service without a problem. In other words, Florida Hospital's proposed facility would be "OB- ready." (Tr. 725). Unlike ORHS, Florida Hospital does not have physician support for providing obstetric services at its proposed facility, a part of the reason for not offering OB. The basis for Florida Hospital's lack of physician support is a malpractice insurance crisis for obstetricians. Florida Hospital's proposed facility is not projected to open for another three years. If, during that time, the malpractice crisis eases and there is greater physician coverage availability, Florida Hospital could open obstetric services at the same the hospital opens since it will be OB-ready. Another reason that Florida Hospital has decided against offering obstetrics upon opening is that most maternity patients are more comfortable delivering babies in a setting that has neonatal intensive care services available. Two such settings are ORHS-Arnold Palmer and Florida Hospital's main campus. Indeed, a significant number of maternity patients from Oviedo are choosing to travel past multiple hospitals that offer obstetric services to have their babies delivered at one or the other of these two hospitals. Arnold Palmer, in fact, is the leading provider of obstetrical services to the residents of the Oviedo area's two most populous zip codes: 32708 and 32765, both more than 30 minutes driving time away from the hospital. Medicaid and Charity Care Conditions Approval of ORHS' CON is conditioned on a minimum of 7% of total annual patient days for Medicaid patients and 1% for charity care. Florida Hospital's application offers no conditions with regard to Medicaid or charity care. Like ORHS, Florida Hospital is one of the top ten providers in the State of indigent care, and a disproportionate share Medicaid provider. The Agency's view of the difference between ORHS' provision of indigent care conditions and Florida Hospital's decision to not condition its application was explained by Mr. Gregg: Conditions [such as those for indigent care] are important when it allows us to distinguish between applicants. They are less important when we have competing applicants, both of whom has such strong track records as these two do. . . . [W]e look at evidence of past performance relative to indigent care . . . . [I]n a case like this . . . both of these applicants have such good records in th[e] area [of indigent care]. They are both in the top ten statewide. . . . [A] promise of this condition or that condition [does not] give us particular concern one way or the other. They are both very good in that area [of Medicaid and charity care] and very tough to distinguish between. (Tr. 735-6). Architectural Design and Site The architectural plans of both applicants meet all codes that apply to a new hospital in the state of Florida. The ORHS design is tried and proven at ORHS' South Lake facility and will work on a 35-acre site. The size of Florida Hospital's site, 15 acres much smaller than ORHS', led to criticism of the site from ORHS experts. But the site is large enough to incorporate growth in the future. It can accommodate 320 beds and ancillary services. The design, moreover, takes these expansion capabilities into account. Related to the size of the site, the site's conservation area, comprised of wetlands and a forested upland buffer that will remain undeveloped indefinitely also produced criticism that the site is too cramped for a new hospital. But the conservation area, with its mature tree canopy, presents advantages. The hospital was designed to incorporate the view of the conservation area from hospital rooms because such a view is beneficial to the healing process. Furthermore, the conservation area can be used to satisfy water retention requirements. Florida Hospital's site is DRI-approved and part of a DRI master storm water plan that connects many ponds and wetlands. Surrounded by three roads, it has excellent access from existing roadways. Vehicular circulation is split to provide different public, service and emergency entrances. Innovation by Florida Hospital Unlike traditional hospital care models where the patient is moved from room to room depending on type and intensity of care, all care and services are provided to the patient in one "universal" room under the "universal delivery of care model." The model was developed by Florida Hospital. "The nursing leadership of the universal room design . . . was under the direction of Connie Hamilton." (Tr. 1080). Ms. Hamilton, accepted as an expert in nursing and nursing administration, explained at hearing that under the model, the room is designed to provide any type of care the patient might need. Whether the patient is admitted in acute care and then moves to intermediate care or med-surg, all care is provided within one "universal" room. Not only does the patient stay in one place, but as Ms. Hamilton testified, "[t]he nurses stay in one place in providing that care to [the patient] and the families know where the patient is and the physician knows where the patient is [at all times]." (Tr. 933). The universal care model streamlines the interactive processes of care of a patient. The care and attention of physicians, nursing staff and families devoted to moving the patient from room to room and keeping track of the patient as type and intensity of care changes is reduced to nearly zero if not eliminated entirely. The time, energy and resources formerly devoted to all that is entailed with changes in the patient's room is then free to be re-directed to care and attention paid to the patient. The result is enhancement of Florida Hospital's ability to provide "whole person" care consistent with Adventist principles of health care. The universal care delivery model is an innovative approach to the delivery of healthcare. Pioneered by Florida Hospital at Celebration Health, the universal care delivery model has been shown there to reduce medical error, reduce length of stay, reduce pharmacy costs, reduce nursing workload, reduce housekeeping work, and probably to reduce infection rates. Following the universal care model employed at Celebration Health, Florida Hospital has designed its proposed Oviedo hospital facility with universal rooms. Consistent with the universal care delivery model, the rooms are designed to improve the healing experience during hospitalization and minimize the patient's feeling of being in a hospital setting. Another benefit of the universal care model is high physician satisfaction due to continuity of nursing care and other factors. The physicians know where the patient is, that is, in the same location every day. Physicians, moreover, are not called at all hours of the day and night to effectuate patient transfers to other rooms. Kathleen Mitchell has studied the universal care model and published and submitted articles on the model to nursing journals. She has consulted with hospitals around the country interested in the model as well as the "health care arm of the Department of Defense, Air Force, Army, Navy, Veteran's Administration." (Tr. 1084). Ms. Mitchell, accepted as an expert in nursing amplified the testimony of Ms. Hamilton. With regard to the problem the universal care delivery model is designed to address, Ms. Mitchell testified: [T]ransferring patients for different levels of care . . . fractures continuum of care. It is . . . disruptive to everyone . . . involved . . . to the patient and their families . . ., to nursing, pharmacy, the physicians . . . . It creates a great deal of anxiety for patient and the families . . . even [those] who are getting better and moving to a lower acuity of care. One of the most significant things about transferring patients for different levels of care is it involves a great deal of work. Not only bundling the patient up, but the documentation and all the communication that goes along with securing a new location for the patient and expediting a transfer. And moving patients around creates a risk of medical error. The length of stay in hospitals has gotten so short and everybody is focused on reducing the length of stay that in the traditional model of care, nurses are turning over more than half their patient assignment daily . . . . [T]here is the confusion and risk that goes along with that. (Tr. 1086-1088). The benefits of the reduction and elimination of transfers produced by the universal care model were listed by Ms. Mitchell: increase in the continuity of care, reduction in nurse workload, high physician satisfaction, reduction in emergency room waiting time, family satisfaction, connectivity between patient, family and staff. Others were elaborated on by Ms. Mitchell. For example, reduction in pharmacy costs, probable reduction in infection and reduction in housekeeping costs: When you are meeting the needs of the patient in one location, you are not leaving medications behind or sending them to the wrong place, and there is work that nurses and pharmacists do with calling each other with ['] where is it, I can't find it, I sent it[',] all that goes away. We are demonstrating a low incidence of nosocomial infections because we expose our patients to one environment of organisms. This is a very difficult one to prove; even though we have a low incidence of nosocomial infections, we also have a fairly new facility [at Celebration], but it makes common sense that if you are reducing the transfer of the patient and the exposure . . . to different environments, you are reducing their exposure to organisms and will have a lower . . . infection rate. . . . [W]e don't strip linens off the beds and clean the beds where the bed was just made three hours ago, with all the patient transfers that are involved. So there is a reduction in . . . housekeeping work and . . . linen expense. (Tr. 1089-1090). Like the housekeeping efficiencies, the nursing staff benefits from the efficiencies associated with supplies. All of the supplies the nurse needs to care for the patient are close by, so the nurse saves time otherwise retrieving supplies from down the hall or in other areas of a hospital wing. Another benefit of the design is "connectivity to the outside world. The rooms have large windows . . . patients feel connected to the outside world . . . . " (Tr. 1091). This design feature will make use of the conservation area on the Florida Hospital site and the soothing vista it will provide to the patient, and assist in the healing process. Other Design Features Design drawings are a living and continually evolving process. The planning process of Florida Hospital for the design of its new Oviedo hospital involved specialty department experts and ancillary representatives discussing delivery of quality care for a patient throughout the system. The specialty experts and ancillary representative include radiology, emergency department, lab, pharmacy, and respiratory. The involvement of these people assures optimal patient flow throughout the system. In Florida Hospital's design plans, the patient flow and interaction between departments are well designed and well laid out so as to minimize the opportunity for confusion. In order to maximize efficiency, a larger number of beds in one nursing unit works better than smaller pockets. Florida Hospital's design plans have one 40-bed unit and one 38- bed unit. This design gives more flexibility and can expand or shrink more easily as needed. You don't have to open up another unit and staff it so often, when adding only one or two patients. Florida Hospital designed its facility specifically to take advantage of the economies of scale that being a satellite hospital in a larger system provide. For example, Florida Hospital's general storage, central lab, and other areas were purposely designed smaller than one would typically find because Florida Hospital operates a system-wide central warehouse, thus greatly reducing the need for central storage areas. Likewise, Florida Hospital operates a system-wide central clinical lab, thus minimizing the space necessary within a hospital like Oviedo for lab space. ORHS did not design its facility to take advantage of the economies scale of being part of a system. Presence in Oviedo Florida Hospital has had a presence in the Oviedo community since the 1970's, when it purchased land in the Red Bug corridor area. In the 1980's, Florida Hospital built a medical office facility in Oviedo and began to recruit and encourage physicians to practice in the area. When Florida Hospital acquired Winter Park Hospital, its commitment to the community of Oviedo increased by virtue of the fact that the Winter Park Hospital organization already had property and outpatient facilities in Oviedo. The result of Florida Hospital's early presence in Oviedo is that it has a high degree of physician support in place in the Oviedo community. Many of the primary care physicians in Oviedo refer their surgical cases to Florida Hospital. Florida Hospital purchased Winter Park Hospital on or about July 1, 2000. With that purchase, Florida Hospital acquired the hospital site in Oviedo. With the purchase of Winter Park Hospital, Florida Hospital also "purchased" Winter Park's plan to build a hospital in Oviedo. The Florida Hospital site has long been recognized as the "Hospital Site" in Oviedo. Immediately after purchasing Winter Park Hospital, Florida Hospital went to work on developing a plan to build a hospital in Oviedo. Florida Hospital began meeting with Oviedo city leaders in the fall of 2000 and early 2001; Florida Hospital also assembled a team of people from all areas of Florida Hospital including radiology, clinical services, marketing, finance, facilities, and engineering to work toward the development of a Certificate of Need application for a hospital on its site in Oviedo. Florida Hospital's two existing medical office buildings in Oviedo contain over 60,000 square feet of medical office space, in which are housed physicians practicing in a wide range of areas including Family Practice, Internal Medicine, General Surgery, Orthopedic Surgery, Urology, Radiology, Gastroenterology, Ear, Nose and Throat, OB/GYN, and Dental and Psychological Practitioners as well. These physicians are all currently on the staff of Florida Hospital. Also included in these facilities are a Florida Hospital owned and operated radiology center, outpatient rehabilitation center, and outpatient lab. The radiology center offers general radiology services, including CT scanning and ultrasound. The larger of the two medical facilities that Florida Hospital owns in Oviedo is located on the site where the new hospital will be located. This is the facility that includes the outpatient radiology, rehabilitation and laboratory services. An urgent care center is also located on the site. As a result, residents of Oviedo are used to coming to Florida Hospital's site for medical services and already recognize it as a medical facility site. The fact that Florida Hospital has such a significant presence in the Oviedo Community, and that a large number of staff physicians are already in place in Oviedo, is a great benefit because of the existing referral patterns in place between the physicians at the existing Florida Hospital facilities in Oviedo and specialists and sub-specialists on Florida Hospital's staff. In contrast, ORHS had an outpatient surgery center in Oviedo; however, it has been closed due to lack of physician support. Likewise, ORHS originally offered radiology diagnostics at its Oviedo office building, but has since sold that business to the radiologists. Finally, ORHS does not own the medical office building in Oviedo anymore, having sold it two weeks before this final hearing commenced. Dr. Joseph Portoghese, a Board Certified Surgeon, practicing in the Orlando area for over 13 years and president- elect of the Florida Hospital medical staff, testified that his group, Surgical Associates, which is made up of six surgeons, derives approximately 20% of their patients from the Oviedo area. In his opinion, Florida Hospital knows the Oviedo population best as evidenced by its "major presence" in Oviedo with its two facilities. Dr. Portoghese also testified that his group knows most of the primary care physicians in the Oviedo area and that a good many of them send their surgical cases to his group. Dr. Portoghese is on the staff of Florida Hospital, but not on the staff of Orlando Regional. Dr. Schamberger, a family practitioner who has practiced in Oviedo for 16 years and whose patients come primarily from the Oviedo, Chuluota, Winter Springs and East Orlando area testified that Florida Hospital has the best infrastructure for the provision of medical care in the Oviedo area. "The physicians who provide a great bulk of the care for that Oviedo, Chuluota, Winter Springs area practice at Florida Hospital. Their referral patterns are to Florida Hospital. Florida Hospital provides us with all the specialty and sub- specialty care we need for our patients." Dr. Schamberger is on the staff of Florida Hospital, but he is not on the staff of Orlando Regional. Dr. Schamberger further testified to the disruption in continuity of care that would occur for many Oviedo area patients whose physicians are on the staff at Florida Hospital if Orlando Regional were to be the only applicant approved to build a hospital in Oviedo: "[I]ts a negative impact for continuity of care. If I have been attending a patient for many years, the first thing that happens to a patient when they get in the hospital is that they have a history and physical examination done to establish what their underlying medical conditions are. I know a lot more about that from my patients than someone who doesn't see them and doesn't know them." (Tr. 1318) Dr. Cintron, a physician practicing in the area of Internal Medicine, whose main office is in Oviedo at the Florida Hospital site, testified that she has approximately 3,000 active files and 75% to 80% of those are in the Oviedo area. She has been practicing in Oviedo since 1994. Dr. Cintron testified that approximately 85% of her patients that get admitted to a hospital are admitted to one of Florida Hospital's facilities. Also, when she makes a referral to a specialist or a sub-specialist, approximately 85% of those patients go to a Florida Hospital facility. Competition "[T]he U.S. health care system is a competitively driven market . . . with some regulatory components and based on a managed care model." (Tr. 485). Rather than every insurance plan having a contract with every provider, the managed care model uses selective contracting. Competing health insurance plans select providers with which to contract for the provision of health care services to their subscribers. The ability of the competing insurance plans to engage in selective contracting requires providers such as the two hospitals in this case to compete along a number of dimensions including price. When successful, this competitive price model holds down price and maintains quality. The State of Florida has a "fairly well developed and active managed care sector." (Tr. 507). "[M]anaged care in and of itself [however] is not really able to save much money for consumers. . . . [T]he key ingredient in the ability of managed care plans to control health care cost increases is the competitiveness of the hospital market, the structure of the market in which they are negotiating on behalf of their health plan subscribers." (Tr. 500). The parties define the "market" differently. Florida Hospital uses the Elzinga-Hogarty ("EH") Test. The test, along with appropriate supplemental information, indicates that the market is all of Orange and Seminole Counties or the tri-county area that also includes Osceola County. Whether a two county or tri-county market, Florida Hospital refers to its market as the metropolitan Orlando market or the "overall Orlando market." Orlando Regional identified a smaller area as the relevant market, one that is more local to Oviedo. The reason for this more local market was explained by Glenn Alan Melnick, Ph.D., and an expert in health care economics who testified for ORHS: [I]n order for [managed care plans] to attract subscribers, they have to have a health plan that's attractive to people. And one of the features that people look for in their health plans is the availability of local hospital services. . . . [I]n order to make their products marketable, they have to include reasonably accessible hospitals . . . [I]f there is limited local competition, then the opportunities for them to generate price competition by leveraging competitive conditions . . . are very limited and [the managed care] model will not be successful. (Tr. 489). Dr. Melnick used the five and eight zip code Oviedo Service Areas as defined by the applicants as the market. He calculated Herfandahl-Hershman Index ("HHI") valuations for each zip code in the two Oviedo Service Areas. He also calculated HHI valuations for another seven zip codes in Orange County "to provide background to [his] understanding of the allocations in [the] area . . . . ." (Tr. 516). Dr. Melnick's calculations showed that Florida Hospital has a market share between 60 and 69% for the five zip codes in Florida Hospital's Oviedo Service Area and it showed a market share of between 25% and 59% for the three zip codes in ORHS' Oviedo Service Area that were not included in Florida Hospital's Oviedo Service Area. In each of the seven zip codes in the area outside the Oviedo Service Area, Florida Hospital's market share was higher: in excess of 70%. The analysis led Dr. Melnick to conclude that the market is highly concentrated in favor of Florida Hospital. Using the zip codes in the Oviedo Service (and it appears from the record the seven not in either applicant's Oviedo Service Area that Dr. Melnick had analyzed for background purposes), Dr. Melnick concluded that if the CON is awarded to Florida Hospital "[i]t would make an already concentrated market much more concentrated." (Tr. 524). Florida Hospital's relative market share would rise from 65.8% to 85.7%. Orlando Regional's would drop from 27.4% to 11.5%. The award of the CON to Florida Hospital would, moreover, "seal its already existing market power into the future." (Id.) Conversely, awarding the CON to ORHS led Dr. Melnick to conclude that the market as he defined it would be more competitive; Florida Hospital relative market share would drop to 51% and ORHS' would rise to 44%. What Dr. Melnick's relative market shares would have been had he not used the seven zip codes he selected outside the Oviedo Service Areas of the two applicants does not appear to have been shown by ORHS. Including the seven zip codes outside the Oviedo Service Areas for determining the relative market share that led to Dr. Melnick's conclusions runs counter to his premise that the market should be a local one, that is, an Oviedo market. It is not clear what relevance these seven zip codes had to his analysis since their inclusion runs counter to the underpinnings of his approach to the issue. If the overall Orlando market used by Florida Hospital is considered the market, the conclusion is that, whether a CON for an Oviedo hospital is awarded to ORHS or Florida Hospital, the impact on relative market share is minimal. As for pricing, there has been no significant pricing difference between Florida Hospital and ORHS for Oviedo residents. Furthermore, both Florida Hospital and ORHS contract with managed care companies on a system-wide basis; Florida Hospital, moreover, uses a single master charge structure for all of its Orlando area campuses. It is not likely that the presence of a hospital in Oviedo would enable either Florida Hospital or ORHS to control pricing.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order on the basis of the facts found in this order concluding that "not normal" circumstances exist for the construction and operation of a new 60-bed hospital in Oviedo and that Florida Hospital's CON application be approved and ORHS' be denied. DONE AND ENTERED this 18th day of November, 2002, in Tallahassee, Leon County, Florida. DAVID M. MALONEY 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 18th day of November, 2002. COPIES FURNISHED: Lealand McCharen, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 James M. Barclay, Esquire Ruden, McClosky, Smith, Schuster & Russell, P.A. 215 South Monroe Street, Suite 815 Tallahassee, Florida 32301 Steven R. Bechtel, Esquire Mateer & Harbert, P.A. Post Office Box 2854 225 East Robinson Street, Suite 600 Orlando, Florida 32802 Stephen K. Boone, Esquire Boone, Boone, Boone, Hines & Koda, P.A. 1001 Avenida del Circo Post Office Box 1596 Venice, Florida 34284 Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Suite 310G St. Petersburg, Florida 33701
