The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint filed July 7, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2006). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2006). Dr. Edison is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 44240. Dr. Edison received his medical degree from the University of Massachusetts; did his residency in general surgery at the Kaiser Foundation in Los Angeles, California; and did a residency in plastic surgery, with specialties in reconstructive surgery and cosmetic surgery. Dr. Edison is certified in plastic surgery by the American Board of Plastic Surgery and is a lifetime diplomate of that Board. Dr. Edison was also certified in Advanced Cardiac Life Support ("ACLS") at the times material to this proceeding. Dr. Edison has been practicing plastic surgery in Florida for 22 years. Prior to the time material to this proceeding, Dr. Edison performed approximately 150-to-200 breast augmentation surgeries each year and approximately 100-to-150 liposuction procedures each year. Dr. Edison practices at the Cosmetic Surgery Center, which is an office that contains two operating rooms, a recovery room, and an overnight recovery facility that is staffed by an ACLS-certified nurse for patients who undergo procedures such as stomach tucks or facelifts. Dr. Edison's surgical practice is limited to Level II office surgery, which is defined in Florida Administrative Code Rule 64B8-9.009, Standard of Care for Office Surgery, in pertinent part as follows: Level II Office Surgery. Scope Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, this making intra and post- operative monitoring necessary. . . . Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Standards for Level II Office Surgery. * * * 4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. . . . The level of pain and anxiety management achieved under Level II sedation is determined by the type of drugs administered and the dosages in which they are administered. Dr. Edison was ACLS certified and was, therefore, authorized to use the services of a registered nurse to administer the drugs that bring patients to Level II sedation. He does not use the services of an anesthesiologist or of a Certified Registered Nurse Anesthetist in his surgical facility. Patient P.L. P.L. first consulted with Dr. Edison on July 5, 2005. P.L. filled out a portion of a Patient Information form, and Dr. Edison took a general medical history from P.L., but he did not weigh P.L. during this initial visit, and the Patient Information form does not include her blood pressure, height, or weight. Dr. Edison found P.L. to be a healthy 29-year-old female, the mother of three children, who had no known allergy or adverse reaction to any medication. P.L. wanted breast implants, and, upon examination, Dr. Edison found that P.L. would be a good candidate, anatomically, for the surgery. Dr. Edison spent the majority of time during this initial consultation talking with P.L. and her husband, A.A., about the various breast implant options. He also discussed with them the risks and possible complications of the surgery. After her visit to Dr. Edison's office on July 5, 2005, P.L. notified Dr. Edison's office that she had decided to have the surgery. Dr. Edison had a cancellation on July 7, 2005, and P.L. was scheduled for surgery for 8:00 a.m. on that date. P.L. returned to Dr. Edison's office on July 6, 2005, for a pre-operative examination. At that time, Dr. Edison did an examination during which he checked P.L.'s heart, lungs, blood pressure, and pulse rate, and he noted the results in his examination notes dated July 6, 2005. He found nothing abnormal and concluded that P.L. was a 29-year-old patient in perfect health, with no known allergy or adverse reaction to any medication. Dr. Edison also had blood drawn during the July 6, 2005, office visit, which was sent to a laboratory for testing. The laboratory report was completed at 8:21 a.m. on July 7, 2005, and showed nothing abnormal. P.L. presented herself at Dr. Edison's office on July 7, 2005, at approximately 8:00 a.m. She was examined by Dr. Edison at 8:10 a.m., and he stated in his office notes that she had decided on the 300 cubic centimeter implant. There were no notations of her vital signs in his office notes. Dr. Edison intended for P.L.'s breast augmentation surgery to be Level II office surgery, and he noted this on P.L.'s Immediate Pre-Op Evaluation, which he completed on July 7, 2005. He also decided to use the transaxillary technique, making incisions under the arms through which to insert the implants under the muscle in P.L.'s chest. Dr. Edison was assisted during surgery by Michelle Hoff, an Advanced Registered Nurse Practitioner, who administered the sedatives and other drugs to P.L. under Dr. Edison's direction. Dr. Edison was also assisted by Liliana Gabor, a surgical technician. Ms. Hoff is not a Certified Registered Nurse Anesthetist, nor has she received any formal training in administering sedative drugs or anesthesia. She has a significant amount of experience administering drugs for pain and anxiety management. Her experience administering drugs to achieve Level II sedation consists of an externship with Dr. Edison while working on her master's degree in nursing and extensive on-the-job training while working in the operating room with Dr. Edison, which she has done every day since beginning to work with Dr. Edison full-time in November 2003. At some point immediately prior to surgery, Dr. Edison asked P.L. her weight, which she reported as 95 pounds, or 43 kilograms, on the morning of surgery. Dr. Edison needed to know P.L.'s weight in order to calculate the correct dosage of the drugs she would be given, and he wrote "95 lbs" on the outside of P.L.'s folder. Dr. Edison noted P.L.'s weight on the outside of the folder so it would be plainly visible to Ms. Hoff when she had the chart on the anesthesia stand.4 Dr. Edison did not enter P.L.'s weight in his examination notes, and the only other mention of P.L.'s weight in the medical records maintained by Dr. Edison is the notation "<100 lbs" on a sheet containing the contact numbers for P.L. and for her husband, who would be picking her up after surgery. At approximately 8:20 a.m. on July 7, 2005, P.L. walked to the operating room. Working under Dr. Edison's direction, Ms. Hoff hooked P.L. up to various monitoring devices, so that her heart, blood pressure, and oxygen saturation level could be monitored during surgery. Her vital signs were noted on the anesthesia chart by Ms. Hoff; at 8:20 a.m., P.L.'s heart rate was approximately 104. At 8:20 a.m., Ms. Hoff began to administer drugs to P.L. to achieve Level II sedation in accordance with directions from Dr. Edison; she documented the name of the drugs she administered, together with the time and dosage administered; she monitored and documented P.L.'s vital signs, including heart rate, blood pressure, and oxygen saturation level; and she maintained anesthesia notes. At 8:20 a.m., Ms. Hoff administered two milligrams of Valium; one gram of Ancef, and 0.2 milligrams of Robinol at Dr. Edison's direction. At 8:25 a.m., she administered 10 milligrams of Ketamine and 10 milligrams of Talwin and started the administration of Diprivan by microdrip at the rate of approximately 25 micrograms per kilogram of weight per minute. Ms. Hoff's notes do not indicate the manner in which she administered the Diprivan, nor the dosage or rate of administration. Ms. Hoff also administered nitrous oxide and oxygen at 8:25 a.m., and she noted that Dr. Edison also began administering local anesthetic by injection at 8:25 a.m. Ms. Hoff noted that P.L. was responding to verbal stimuli. Ms. Hoff was not involved with the preparation or administration of local anesthetic to P.L. Dr. Edison prepared a dilute solution of 70 cubic centimeters of 1% Lidocaine with epinephrine with 350 cubic centimeters of saline solution and 10 cubic centimeters of 1/2% marcaine. At approximately 8:25 a.m., Dr. Edison began injecting the Lidocaine solution, which totaled approximately 700 milligrams or approximately 14 milligrams of Lidocaine per kilogram of P.L.'s body weight and 50 milligrams of marcaine, into the tissue surrounding P.L.'s breasts. At 8:30 a.m., Ms. Hoff, at Dr. Edison's direction, administered another 10 milligrams of Talwin. At 8:35 a.m., P.L.'s heart rate was 112 beats per minute and her blood pressure was 142/102. At Dr. Edison's direction, Ms. Hoff administered 1/4 cubic centimeter of Labetalol to help control P.L.'s blood pressure. Ms. Hoff noted that P.L. tolerated the Labetalol well and was responsive to verbal stimuli. At 8:45 a.m., Ms. Hoff noticed a brief facial twitch on P.L.'s face, which is an indication of a possible seizure. At Dr. Edison's direction, she immediately stopped administering all sedatives, and the surgery was cancelled. At Dr. Edison's direction, Ms. Hoff administered 2.5 milligrams of Valium to keep P.L. sedated and to help control the seizure, together with three liters of oxygen by mask. At 8:55 a.m., Ms. Hoff administered another 2.5 milligrams of Valium at Dr. Edison's direction,5 and she noted that P.L.'s status was unchanged, by which Ms. Hoff meant that P.L.'s airway, breathing, and circulation were maintained, that her vital signs were stable, and that she remained responsive to verbal stimuli. Between 8:55 a.m. and 9:15 a.m., P.L.'s status was unchanged. According to Ms. Hoff's notes, P.L.'s airway, breathing, circulation, and vital signs were maintained at normal levels, and she responded well to the Valium and oxygen. Ms. Hoff observed during this time that P.L. was lethargic and appeared to be a little more deeply sedated than typical Level II sedation. P.L. continued breathing on her own and responding to verbal stimuli. During this interval, Dr. Edison was waiting for P.L. to come out of sedation, and he intended to send her home and recommend that she see her doctor about the twitch. Ms. Hoff noticed a second facial twitch between 9:15 a.m. and 9:20 a.m., and Dr. Edison directed Ms. Hoff to call Emergency Medical Services to transport P.L. to the hospital. Ms. Hoff continued to monitor P.L.'s airway, breathing, circulation and vital signs until the Emergency Medical Services team arrived at 9:30 a.m. During this time, Ms. Hoff noted that P.L. responded to verbal stimuli by moving her head a little bit and attempting to open her eyes. P.L.'s oxygen saturation rate was consistently maintained at 99% to 100% between 8:20 a.m. and 9:30 a.m., when Emergency Medical Services arrived. During this time, P.L. was breathing independently and did not need any assistance with her airway. Emergency Medical Services received the call from Dr. Edison's office at 9:21 a.m. and arrived at 9:26 a.m. At that time, P.L. was receiving oxygen, her airway was normal, and her perfusion was good. Her blood pressure was 102/68, her pulse was strong and regular at 120 beats per minute, her respiratory rate was 20, her respiratory effort was normal, and her breath sounds were clear. She was, however, non-responsive: She was not able to open her eyes, she had no motor response, and she was not able to give a verbal response. She appeared to be having seizure activity in the form of twitching on both sides of the jaw line. P.L. was transported to Memorial Regional Hospital at 9:31 a.m., and she arrived at the hospital at 9:36 a.m. A notation on the EMS Report for the incident states that a "[l]ist of sedation medication [was] given to ER staff." Dr. Todd Gardner was the emergency room physician who treated P.L. on her arrival at Memorial Regional Hospital. His diagnosis on admission was status epilepticus and hypoxia. Status epilepticus is seizures that are unrelenting to normal therapeutic intervention, and hypoxia is low oxygen level. Dr. Gardner did not attribute a cause to the status epilepticus. Dr. Gardner's intake notes reflect that, prior to presenting at the emergency room, P.L. had received Ketamine, Labetalol to lower her blood pressure, and Valium to relieve the seizures. Nothing on the intake sheet indicates that P.L. had received Lidocaine, and there is no list of the medications given by Dr. Edison in the hospital file. Dr. Gardner intubated P.L. at 10:02 a.m. and placed her on a ventilator in the emergency room because she was unable to breathe on her own. He also treated her with Valium, Dilantin, and Diprivan, which is used to sedate patients in the intensive care unit. Dr. Robert Alterbaum, an internist specializing in pulmonary medicine and critical care, provided care to P.L. in the intensive care unit of Memorial Regional Hospital. P.L.'s chest X-ray was abnormal and showed pneumonitis, or an inflammation of the lungs, caused by fluid being aspirated into the lungs. Based on the emergency room chart, Dr. Alterbaum diagnosed P.L. with status epilepticus, or seizures, related to the administration of Ketamine during the pre-operative procedure for breast augmentation surgery. There was no objective medical evidence to support Dr. Alterbaum's conclusion that Ketamine was the cause of the seizures; he reached this conclusion because Ketamine was the only medication noted on the chart as having been administered to P.L. Dr. Alterbaum was not aware that P.L. had also received Lidocaine; had he been aware of this, it might have been information he would have considered in reaching his conclusion regarding the cause of P.L.'s seizures.6 P.L. was discharged from Memorial Regional Hospital on July 12, 2005. She had difficulty walking at first, but has fully recovered except that she sometimes experiences a little memory loss. Drugs administered to P.L. Valium Valium is a benzodiazopene used to control anxiety, and the standard dosage ranges from two to 20 milligrams for conscious sedation. Valium is a controlled substance. Ancef Ancef is an antibiotic. Ketamine Ketamine is a disassociative non-barbiturate analgesic used for sedation and general anesthesia; the maximum dosage is 4.5 milligrams per kilogram of body weight. Ketamine causes a large amount of secretions, and its effects last only five to 10 minutes. Ketamine is a controlled substance. Robinol Robinol is an anticholinergic medication used to prevent bradycardia, a heart rate of less than 60 beats per minute, and to help dry out secretions in mucous membranes. Robinol is contraindicated for a patient with tachycardia, or a heart rate of more than 100 beats per minute, however, because it could make the patient's heart rate increase. In a healthy 29 year-old patient such as P.L., however, it was not a violation of the standard of care to administer 0.2 milligrams of Robinol to P.L. even though her heart rate was 104 beats per minute at the time it was administered; a healthy 29-year-old patient could easily sustain a heart rate of 140 beats per minute without ill effects. Dr. Edison administered Robinol to P.L. as a drying agent, to control secretions brought on by the use of Ketamine. Although other drugs can be used to control these secretions, Robinol is the best drug for this purpose and the one most commonly used. Dr. Edison had ample justification for using Robinol under the circumstances, and he did not violate the standard of care by ordering Ms. Hoff to administer the drug even though P.L.'s heart rate slightly exceeded 100 beats per minute. Talwin Talwin is an opiate analgesic that is used to control pain, and the standard dosage is 30 milligrams. Talwin is a controlled substance. Nitrous oxide Nitrous oxide is an anesthetic gas that is used for analgesia and sedation; it was administered to P.L. by nasal cannula, which delivers a relatively small amount of gas. Diprivan Diprivan is a sedative hypnotic medication used both for intravenous sedation and for general anesthesia; the package insert recommends a dosage from 100 to 150 micrograms per kilogram of body weight per minute. Diprivan's clinical effects wear off approximately three minutes after its administration is discontinued. The total dose of Diprivan administered to P.L., 25 milligrams, was included in Dr. Edison's medical records, but the manner of administering the Diprivan and the rate of infusion are not recorded. Diprivan, together with other sedative drugs, may be administered in Florida by a registered nurse at the direction and under the supervision of a surgeon during Level II office surgery.7 Dr. Edison did not deviate from the standard of care in Florida by delegating responsibility to Ms. Hoff, an Advanced Registered Nurse Practitioner, for administering the various drugs to P.L., under his direction and supervision. Based on her training and experience, Ms. Hoff was qualified to administer these drugs to P.L. to achieve Level II sedation under Dr. Edison's direction and supervision. The combination of sedative drugs Dr. Edison ordered administered to P.L., specifically Diprivan, Ketamine, Talwin, Valium, and nitrous oxide, was appropriate to induce Level II sedation in P.L., and the dosage of each of the drugs administered to P.L. was well below the maximum dosage recommended for each of the drugs. These drugs work synergistically, however, and, depending on the patient and the circumstances, the same combination of sedative drugs could induce Level III sedation. Florida Administrative Code Rule 64B8-9.009 defines Level III office surgery and sets forth the standards that must be met, in pertinent part, as follows: Level III Office Surgery. Scope. Level III Office Surgery is that surgery which involves, or reasonable should require, the use of a general anesthesia or major conduction anesthesia and pre- operative sedation. This includes the use of: Intravenous sedation beyond that defined for Level II Office Surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions: or Major conduction anesthesia. * * * Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: * * * 4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. . . . One difference between Level II and Level III sedation is the degree of alertness of the patient. At Level II sedation, the patient must be able to respond to verbal and/or tactile stimuli. If a patient's only response is a reflexive withdrawal from a pain stimulus, the patient is sedated beyond Level II. A primary indication that a patient has slipped from Level II to Level III sedation is the loss of the ability to breathe without assistance, and the patient's airway must be partially or totally managed. In Level II sedation, the need for management of the airway is minimal compared to that required at Level III sedation. P.L.'s blood pressure, pulse rate, oxygenation, and mental state were consistent with Level II sedation until P.L. had her first seizure and all medications, except for the one- half therapeutic dose of Valium, were discontinued. She remained responsive to verbal stimuli after the second 2.5 milligram dose of Valium was given to control the seizure activity, even though she was more lethargic than normal under Level II sedation. P.L. was non-responsive when examined by Emergency Medical Services personnel, but she was breathing independently and was not at Level III sedation. Her lack of response was more likely than not the result of the seizures, after which a patient can go into a postictal state, or a trance of sleepiness.8 Dr. Edison did not violate the standard of care for office surgery in ordering the amounts and combination of drugs used to sedate P.L. because P.L. did not reach Level III sedation. In accordance with the standard of care for Level II office surgery, Ms. Hoff, as a registered nurse, was qualified to administer anesthesia to P.L., including Diprivan, Ketamine, and the other sedative drugs used in P.L.'s surgery, at the direction and under the supervision of Dr. Edison. Dosage of Lidocaine As stated above, Dr. Edison injected a dilute solution of Lidocaine with epinephrine and marcaine into the tissue around P.L.'s breasts between 8:25 a.m. and 8:45 a.m., before P.L. had her first seizure at 8:45 a.m. Lidocaine is a local anesthetic used to numb nerves and tissue. In breast augmentation surgery Dr. Edison always uses Lidocaine with epinephrine because epinephrine is a vasoconstrictor that causes intense vasoconstriction, or closing of the small blood vessels, which slows the rate of absorption of the Lidocaine and virtually eliminates bleeding at the site of surgery. Marcaine is also a local anesthetic similar to Lidocaine, but it is slow to take effect and lasts four to six hours and helps control pain after surgery is completed. Marcaine is commonly used with Lidocaine. It is Dr. Edison's practice to perform breast augmentation surgery using the tumescent infiltration technique to infuse a relatively large volume of dilute Lidocaine solution into the breast area as a local anesthetic. Dr. Edison uses this tumescent infiltration technique in breast augmentation surgery because he can deliver a large volume of Lidocaine that is evenly distributed throughout the breast area, which results in more effective pain reduction. The injection technique Dr. Edison uses for tumescent infiltration in the breast area is very specific, and it takes between 20 and 30 minutes to complete the injections. The needle cannot penetrate close to the pectoral muscle, especially in a woman as small as P.L., because of the danger of puncturing a lung. Dr. Edison injects the solution under pressure into the subcutaneous tissue between the breast and the pectoral muscle. Lidocaine is absorbed faster in areas that are highly vascular. The tissue in the aerolar space between the breast and the pectoral muscle does not contain many blood vessels, so Lidocaine injected in this tissue is absorbed more slowly than it would be if injected into highly vascular tissue. In Dr. Edison's experience, because the epinephrine in the Lidocaine solution causes intense vasoconstriction in the tissue surrounding the injection sites, the Lidocaine stays in place and numbs the area in which the surgery is to be performed. The Lidocaine solution is absorbed slowly over approximately 24 hours, and the peak serum concentration of Lidocaine occurs approximately 10 to 12 hours after it is administered. In this case, Dr. Edison prepared approximately 400 cubic centimeters of solution, which contained 700 milligrams of Lidocaine and 50 milligrams of marcaine, together with a small, non-therapeutic dose of epinephrine. According to his surgical notes, Dr. Edison began the injections of Lidocaine at 8:25 a.m. and had completed the injections by the time P.L. had the first seizure at 8:45 a.m., although it is his recollection that he had not used all of the Lidocaine solution he had prepared. Dr. Edison did not, however, record in the medical records the amount of Lidocaine solution he injected, and any remaining solution was discarded without being measured, so he does not know the dosage of Lidocaine P.L. actually received. Had he injected all of the solution, P.L. would have received approximately 14 milligrams of Lidocaine per kilogram of body weight. According to the package insert that accompanies a bottle of Lidocaine, the maximum dosage of Lidocaine without epinephrine is five milligrams per kilogram of body weight, and the maximum dosage of Lidocaine with epinephrine is seven milligrams per kilogram of body weight. There is nothing in Dr. Edison's medical records to indicate that the Lidocaine he used in P.L.'s surgery included epinephrine or that he calculated the amount of Lidocaine to administer to P.L. based on her body weight Using the maximum dosage specified on the package insert, the maximum dosage of Lidocaine without epinephrine for P.L. would have been 215 milligrams, and the maximum dosage of Lidocaine with epinephrine would have been 301 milligrams, using the traditional method of administering the drug. Based on the standard established by the package insert, Dr. Edison exceeded the maximum dosage of Lidocaine with epinephrine injected into P.L. by approximately 400 milligrams, which constituted a toxic dose of Lidocaine when measured by the maximum dosage stated on the package insert. The maximum dosage of Lidocaine with epinephrine stated on the package insert is routinely exceeded by surgeons performing liposuction, which involves suctioning fatty tissue. The tumescent infiltration technique using Lidocaine with epinephrine in a dilute solution is commonly used with liposuction, and Florida Administrative Code Rule 64B8- 9.009(2)(d), which sets out the standards of care for office surgery, specifically provides that a "maximum of fifty (50) mg/kg of Lidocaine can be injected for tumescent liposuction in the office setting." Large dosages of Lidocaine can be safely used in liposuction because Lidocaine is metabolized more slowly by fatty tissue than by muscle or skin, and approximately 20% of the Lidocaine solution is suctioned out of the body with the fat that is aspirated during liposuction. As a result, it is possible to administer what would otherwise be toxic doses of Lidocaine under the maximum dosages specified in the package insert. Dr. Edison has used the tumescent infiltration technique many times in performing breast augmentations without his patients' suffering any ill effects. There is, however, no rule in Florida equivalent to that relating to liposuction that permits the use of high dosages of Lidocaine as local anesthetic in breast augmentation surgery. Furthermore, Dr. Edison has failed to submit persuasive evidence of a standard of care in Florida among plastic surgeons that would permit the use of dosages of Lidocaine with epinephrine in excess of the seven milligrams per kilogram specified on the package insert for breast augmentation surgery.9 Dr. Edison violated the standard of care by injecting approximately of 700 milligrams of Lidocaine with epinephrine into the tissue surrounding P.L.'s breasts when the maximum allowable dosage, according to the insert packaged with the drug and based on P.L.'s weight, was approximately 300 milligrams. Dr. Edison's previous discipline10 Dr. Edison was charged in an Administrative Complaint dated February 21, 1995, with having committed medical malpractice in violation of Section 458.331(1)(t), Florida Statutes. He executed a Consent Agreement in which he neither admitted nor denied the factual allegations in the complaint but agreed that, if proven, the facts would constitute a violation of Section 458.331(1)(t), Florida Statutes. The Agency for Health Care Administration entered a Final Order dated August 20, 1995, adopting the Consent Agreement in relevant part. This Final Order does not establish that Dr. Edison committed a violation of Section 458.331(1)(t), Florida Statutes. In a Final Order entered January 4, 2007, the Board adopted the recommended disposition in the Recommended Order in Department of Health, Board of Medicine v. Richard B. Edison, M.D., DOAH Case No. 06-0598PL (Recommended Order August 25, 2006), that Dr. Edison be found guilty of a single violation of Section 458.331(1)(m), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order Dismissing Counts Three and Four of the Administrative Complaint; Finding Dr. Edison guilty of a single violation of Section 458.331(1)(m), Florida Statutes, and of two violations of Section 458.331(1)(t)1., Florida Statutes; Suspending Dr. Edison's license for a period of 90 days, followed by four years' probation under such terms as shall be imposed by the Board; and Imposing an administrative fine in the amount of $15,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S PATRICIA M. HART 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 1st day of May, 2007.
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
The Issue The issue in this case is whether the challenged portions of Rule 64B8-9.009, Florida Administrative Code, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact In 1994, Respondent, Florida Board of Medicine promulgated Rule 61F6-27.16, Florida Administrative Code. The Rule was later renumbered twice before being referenced as 64B8- 9.009, Florida Administrative Code. In 1998, the Florida Legislature provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings, including, but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manuals in order to establish grounds for disciplining doctors." Section 458.331(1)(v), Florida Statutes. On March 13, 1998, Respondent published in the Florida Administrative Weekly (FAW) a Notice of Proposed Rule-making concerning the Rule, followed by the first meeting of Respondent's Surgical Care Committee with respect to potential amendments to the Rule. After additional meetings, all of which were properly noticed in the FAW, the Surgical Care Committee presented its recommended amendments to the Rule to the full Board of Medicine from December 4-6, 1998. The full Board did not accept the Surgical Care Committee's recommendation completely, but rather voted to alter the proposed amendments. These latter amendments were approved by the Board at its January 6, 1999, conference call. On April 11, 1999 and June 3, 1999, the Board held additional public hearings, leading the Board to publish two Notices of Change, the second of which was published on June 18, 1999. Among the amendments contained in Rule 64B8-9.009 as proposed on June 18, 1999, was a deletion of Section (4)(b) which required those physicians not having staff privileges to perform the same procedure as that being performed in the office to have a "transfer agreement" with a licensed hospital within reasonable proximity. The Board considered replacing this mandate with a "transfer protocol." The June 18, 1999, version also considered a change to Section (6)(b)1., thereby permitting certain physicians to perform Level III surgery without hospital staff privileges and eliminating the mandated presence of a physician anesthesiologist. On July 8, 1999, the Florida Society of Anesthesiologists (FSA) and the Florida Hospital Association, et al. (FHA) filed separate rule challenges seeking to invalidate the proposed Rule (DOAH Case Nos. 99-2974RP and 99-2975RP, respectively). On August 7, 1999, the Board of Medicine held an additional public hearing, where further amendments were made to the Rule, none of which materially affected the above sections. A third Notice of Change was published on August 20, 1999, reflecting these amendments approved on August 7, 1999, by the Board. During the Fall of 1999, the incoming Chairman of the Board of Medicine, Dr. George El-Bahri, held several private settlement negotiations with the parties to the various rule challenges. Nevertheless, as of the Board's December 4, 1999, meeting, no settlement had been reached in either challenge, and the Board voted unanimously to proceed with the rule challenge litigation and make no further changes to the proposed amendments. This course of action was confirmed by the Board during its January 2000 conference call. Following the Board's January conference call, the parties to the pending litigation agreed to "submit to the Department of State for codification" those sections of the proposed amendments which were not at issue in the litigation. As a result, the Board, FSA, and FSPS entered into a joint stipulation on January 26, 2000. The FHA filed a Partial Voluntary Dismissal on January 28, 2000, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(g)1. and 2.; and (6)(b)1a. and 6., which are not at issue in this case. On January 28, 2000, the Board properly filed with the Department of State, portions of the proposed amendments which were no longer subject to the pending litigation, with the rule in its current form becoming effective on February 17, 2000. Because any proposed amendments relating to transfer protocols and Level III staff privileges were withdrawn and no longer being considered, they were not filed for adoption on January 28, 2000. Those existing sections remained unchanged in the rule and were renumbered by the Department of State. Petitioners challenge each of the approved amendments to Rule 64B8-9.009 which became effective on February 17, 2000, alleging that the provisions of the existing rule are an invalid exercise of delegated Legislative authority under Section 120.52(8), Florida Statutes. Specifically, Petitioners challenge the following Subsections of Rule 64B8-9.009. Subsection (1)(a) which provides that the rule covers "any elective procedures for aesthetic, reconstructive, or cosmetic purposes;" Subsection (2) which Petitioners allege imposes costly record-keeping requirements; c. Subsections (2)(d), (3), (4), (5), and (6) which Petitioners allege limit the types and durations of aesthetic reconstructive and cosmetic procedures which may be performed in Petitioners' office surgical suites; Subsections (4)(e) and (6)(e) which Petitioners allege impose costly equipment requirements; Subsections (4)(f), (5)(b)2., and (6)(f) which Petitioners allege impose costly personnel requirements; Subsections (3), (4), (5), and (6) which Petitioners allege establish levels of surgery unrelated to any rational classification scheme. Petitioners further challenge Subsection (3)(b) and (4)(b) of Rule 64B8-9.009 relating to transfer agreements and staff privileges as they existed prior to February 17, 2000, which contain the exact same language in Subsections (4)(b) and (6)(b) of the current version of the Rule. PARTIES Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Petitioner Smith practices cosmetic surgery, plastic surgery, and oral-maxillofacial surgery in his office. Petitioner Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery, a degree in medicine from the University of Florida College of Medicine, residency at the University of Florida with an internship in general surgery, and served as a faculty member at the University of Florida College of Dentistry in the Department of Oral and Maxillofacial Surgery at Shands Hospital Jacksonville. After specialty training in cosmetic surgery, Petitioner Smith opened his private practice in 1991. Petitioner Smith performs various surgical procedures in his office, including hair transplantation, cosmetic eyelid surgery, functional eyelid surgery, cosmetic and functional nasal surgery, face, neck, and forehead lifts, tumor reconstruction, liposuction, abdominoplasties, breast implants, and breast reductions. Petitioner Smith is also President of the Florida Academy of Cosmetic Surgery, Inc. (Academy). Petitioner Academy is an organization of multispecialty physicians who perform both cosmetic and functional surgery in their offices. Functional surgery means surgery being performed as part of a disease process or correcting some deformity and is generally not done for purely cosmetic reasons. Petitioner Charles E. Graper, D.D.S., M.D., FACS, is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Petitioner Graper received his doctorate in dental surgery from Emory University in 1971, his medical degree from Hahnemann University Medical School in 1983, and received one year of post-graduate training in general surgery at Orlando Regional Medical Center. Petitioner Graper is Board- certified by the American Board of Oral and Maxillofacial Surgery, Board-certified in general cosmetic surgery, Board- eligible in general plastic surgery, and is a Fellow of the American College of Surgeons (FACS). Petitioner Graper performs in his office cosmetic surgery, functional surgery, and surgery below the head and neck which would not be authorized by his dental license. Petitioner Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. The Board The Board regulates the practice of medicine in Florida, and is the agency that adopted the Rule at issue. It is comprised of 15 members appointed by Florida's Governor and confirmed by the Florida Senate. The FSPS and the FSD The FSPS and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. The FSA The FSA is a not-for-profit professional membership organization representing approximately 2,000 anesthesiologists in Florida. FSA members practice in educational institutions, hospitals, ambulatory surgical centers, and physicians' offices. The purpose of the FSA is to provide its members information about anesthesiology and to inform the public about issues particular to anesthesiology. The Hospitals The Florida Hospital Association, Inc. (FHA) and the Association of Community Hospitals and Health Systems (ACHHS) are nonprofit trade associations which represent over 200 hospitals and health systems. FHA and ACHHS represent member hospitals and health systems on common interests before the branches of government, particularly with respect to regulations that impact the members. Rule Adoption Procedures In light of the filing of the Joint Stipulation in DOAH Case No. 99-2974RP, and the filing of the Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, the proposed amendments to Rule 64B8-9.009 were no longer subject to challenge, with the exception of the proposed changes to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)2., (6)(b)1.a. and (6)(b)1.b. Accordingly, on January 28, 2000, the Board filed the proposed amendments to Rule 64B8-9.009 that were no longer subject to challenge with the Department of State for adoption. Liz Cloud is the bureau chief for the Department of State's Bureau of Administrative Code (BAC). Ms. Cloud serves as the filing officer for rules and regulations filed by agencies, all laws passed by the legislature and any advertisements for publication in the Florida Administrative Weekly. She oversees the publishing of the Florida Administrative Weekly and the Florida Administrative Code and has served in that position since 1977. The BAC has rule-making requirements which agencies must follow in order to file a rule for adoption. When the BAC receives a rule that is filed for adoption, specific documents must be included, or the agency is required to resubmit a corrected rule packet. The BAC verifies that the certification from the Joint Administration Procedures Commission has been received and that all the required time frames have been met. BAC checks to ensure the rule is filed within the 90-day limit in Section 120.54(3)(e), Florida Statutes, and determines if there is a challenge to the rule. The BAC receives a weekly computer printout from JAPC on which Cloud's staff relies to determine if there are outstanding rule challenges to a rule being filed for adoption. The BAC's role in the rule-making process is not merely ministerial. If, for example, an agency files a rule on which the 90-day time limit has run, the BAC rejects the rule and does not file it for adoption. Nancy Murphy is a research associate at the Office of the Attorney General. With regard to rules and rule promulgation, Ms. Murphy drafts the documents necessary for rule- making, including notices of rule development, notices of rule- making, supporting documents that have to be supplied to JAPC and any documents that have to be prepared for adoption of rule. Prior to filing a rule for adoption, Ms. Murphy verifies that the time frames are correct and she has all the documents that are required for adoption, including the certificate, the additional statement, and the correct copy of the rule text and coded copy, which is the underlined and struck- through version of the rule. Ms. Murphy also determines whether the rule is subject to challenge before it is filed, and if JAPC has received a written response to all correspondence. Ms. Murphy was responsible for filing the amendments to Rule 64B8-0.009 for adoption. In determining which portions of the rule could be filed and which remained under challenge, she reviewed the Joint Stipulation and the Hospitals' Notice of Partial Voluntary Dismissal in DOAH Case Nos. 99-2974 and 99- 2975. Ms. Murphy redrafted and renumbered the proposed amendments to Rule 64B8-9.009 to be filed for adoption, excluding the sections that were still under challenge, after consultation from Ms. Cloud's office. Ms. Murphy also met with Vicky Macintosh at the BAC to review the Rule section-by-section before filing. Ms. Murphy provided a copy of the Joint Stipulation and Notice of Partial Voluntary Dismissal to establish the provisions of the Rule still under challenge. Murphy also consulted with JAPC prior to filing the amendments to Rule 64B8-9.009 for adoption. The BAC's standard operating procedure with regard to a rule challenge that challenges only a portion of a proposed rule is to accept for filing the unchallenged portions of the rule. This procedure has been strictly followed in the past, and approved by the BAC's counsel. Pursuant to that policy, the BAC permitted the Board to file for adoption those portions of Rule 64B8-9.009 not subject to challenge on January 28, 2000. The BAC received a certification from JAPC that permitted the filing of Rule 64B8-9.009 pursuant to Section 120.54(3), Florida Statutes. Based upon the evidence presented, it is concluded that, although the Board had considered amendments to Sections (3)(b) and (4)(b) involving transfer agreements and Level III staff privilege requirements, they were withdrawn and no longer subject to the pending litigation in DOAH Case Nos 99-2974 and 99-2975 after the Board agreed to make no change. Petitioners have not met their burden of proving that the Board materially failed to follow the rule-making procedures and requirements of Chapter 120, Florida Statutes. Record-Keeping Requirements: Subsection (2) Petitioners presented no evidence with regard to the record-keeping requirements or the cost of the record-keeping requirements imposed by Rule 64B8-9.009(2). Accordingly, Petitioners have not met their burden of proof in challenging this subsection of the rule. Limitation on Types and Duration of Procedures: Subsections (2)(d), (3), (4), (5), and (6) Subsection (2)(d) of Rule 64B8-9.009 states: In any liposuction procedure, the surgeon is responsible for determining the appropriate amount of supernatant fat to be removed from a particular patient. A maximum of 4000 cc supernatant fat may be removed by liposuction in the office setting. A maximum of 50 mg/kg of Lidocaine can be injected in the office setting. Petitioners claim that a limitation of 4000 cc on liposuction is arbitrary and unreasonable since a physician cannot accurately estimate the amount of fat to be taken out. Notwithstanding, Petitioners' witnesses acknowledged that the risk of a liposuction procedure is heightened as the volume of fat removed and the level of anesthesia increase. Petitioners' Exhibit 8, a journal article entitled "Does the Location of the Surgery of the Specialty of the Physician Affect Malpractice Claims in Liposuction?" supports this view. It states: "Large-volume liposuction (over 4000 cc) is inherently risky, but it also involves more aggressive anesthesia, adding to its danger. Risk management for liposuction should stress smaller liposuction procedures using local anesthesia, with minimal sedation." Petitioners' Exhibit 8 also includes the "2000 Guidelines for Liposuction Surgery" of the American Academy of Cosmetic Surgery. Those guidelines recommend volumes of up to 4000 cc of supernatant fat removal in the routine liposuction process. The Board received extensive testimony and information regarding the limitation of removal of tissue in office-based surgery as part of its rule-making process. In setting the volume limit for liposuction, the Board considered the amount of material removed, the Lidocane dosage required, and fluid replaced. The Board considered testimony supporting no limit on liposuction volume, and testimony supporting limitations on volumes as low as 2000 cc. The Board determined that the consensus among experts around the country is that 4000 cc is the appropriate ceiling to ensure the safety of patients undergoing liposuction procedures in the office environment. This conclusion is reasonable and amply supported by the rule-making record. Petitioners presented no evidence at hearing regarding other limitations on types or duration of procedures relating to Subsections (3), (4), (5), or (6) of Rule 64B8-9.009. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions. Equipment Requirements: Subsections (4)(e) and (6)(e) Petitioners presented no evidence at hearing regarding the equipment requirements of subsection (4)(e) of Rule 64B8- 9.009, or the cost thereof. Accordingly, they have not met their burden of proof with respect to these provisions. With regard to Subsection (6)(e) of Rule 64B8-9.009, the only evidence presented by Petitioners at hearing related to the requirement that at least 36 ampules of Dantrolene be available on-site at a physician's office where Level III Office Surgery is being performed. Petitioners claim that the requirement in subsection (6)(e) for 36 ampules of Dantrolene is unreasonable. The cost of 36 ampules of Dantrolene can be as much as $2,000.00 and the shelf-life of Dantrolene is approximately one to two years. The evidence presented at hearing indicated that the manufacturer of Dantrolene will replace it for free if the shelf- life expires, and therefore, shelf-life of Dantrolene is not an economic consideration. The manufacturer of Dantrolene advises that 36 ampules of Dantrolene are necessary to ensure that a patient suffering from malignant hypothermia can be saved. The more persuasive evidence supports the Board's decision to impose a requirement consistent with this recommendation. Personnel Requirements: Subsections (4)(f), (5)(b)2., and (6)(f) Petitioners presented insufficient evidence regarding the cost of additional personnel required by Subsections (4)(f), (5)(b)2, or (6)(f) of the existing Rule. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions. Petitioners did, however, present some general testimony with regard to Subsection (4)(f) of Rule 64B8-9.009. The evidence was insufficient, however, to prove that Subsection (4)(f) is invalid. That Subsection states: Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in Rule 64B8-30.012(b)(6), Florida Administrative Code, or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed in Advance Cardiac Life Support or, in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia. Petitioners have not presented any persuasive evidence that this requirement is vague, arbitrary, or unreasonable. Evidence was presented that during meetings of the FACS, Dr. Anthony Rogers has held courses in conscious sedation to train non-anesthesiologist physicians to be providers of anesthesia for Level II Office Surgery. Dr. Rogers testified that he does not instruct surgeons on administering anesthesia to patients upon which the surgeons are performing surgery. Rather, he trains the surgeons to serve as anesthesia providers for other surgeons as well as providing them with a better understanding of "what's happening on the other side of the table." The training given by Dr. Rogers consists of approximately six to eight hours of staged administration of anesthesia and discussion of hypothetical scenarios. The training does not involve the actual administration of anesthesia by the physicians-in-training. Physicians attending Dr. Rogers' training course are not required to be certified in Advance Cardiac Life Support. No examination is administered as part of Dr. Rogers' training course, and no certification is issued for completion. Even assuming that some FACS members have completed Dr. Rogers' course, the requirement in Subsection (4)(f) for assistance by a qualified anesthesia provider has not been shown to be unreasonable. Levels of Surgery: Subsections (4), (5), and (6) Petitioners contend that the definitions of the various levels of surgeries provided in the Rule are impermissibly vague. Subsection (4) of Rule 64B8-9.009 defines Level I Office Surgery to include: Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical or none. No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in Level I Office Surgery. Subsection (5) of Rule 64B8-9.009 defines Level II Office Surgery as follows: Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intra and post- operative monitoring necessary. Such procedures shall include, but not be limited to, hemmorroidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000 cc supernatant fat. Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflect withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Subsection (6) of Rule 64B8-9.009 defines Level III office surgery as follows: Level III Office Surgery is that surgery which involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes the use of: Intravenous sedation beyond that defined for Level II office surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or Major Conduction anesthesia. The definitions of the three levels of office surgery are based on definitions developed by the American Society of Anesthesiologists and have been adopted in substantially similar form in other states. The American Society of Anesthesiologists is recognized as a group of specialists in anesthesia. Petitioners acknowledged the expertise of the American Society of Anesthesiologists in developing definitions of levels of office surgery. Petitioners argued that the classifications of levels of surgery in the Rule are irrational and vague because it is virtually impossible to differentiate between the various levels of surgery as defined in the Rule. However, the more persuasive evidence establishes that classifications were reasonably based on accepted medical standards. In discussing the potential for a particular patient to drift between what has been defined as Level II anesthesia and Level III, Petitioners' witness, Dr. Rogers testified that medicine itself is vague in this area because there is no machine to tell you if a patient is unconscious. He suggested that anesthesia is a continuum and there is no clear way to define levels of surgery. Dr. Carl Lentz, Board-certified plastic surgeon, supported the Rule's classification scheme. In his opinion, the differences between Levels II and III are clearly understood. When preparing for surgery, a surgeon develops an anesthesia plan. The procedures are distinctly different for each level. If, during surgery, a patient temporarily crosses the line of consciousness, which is apparent if the patient is appropriately monitored, actions to reverse the level can be taken quickly. According to Lentz, if a surgeon does not determine, prior to surgery, the level of anesthesia to be provided, the surgeon should not be performing the surgery. Petitioners complain that the terms "appropriate," "adequate," and "unpleasant" are vague. Although the Petition identifies no other specific terms that are vague, during the hearing, Dr. Graper suggested that numerous other terms contained in Rule 64B8-9.009 are vague, including, "preoperative," "medication," "minimal," "tranquilization,," "anesthesia," "local," "drug-induced," "consciousness," "sedation," "intravenously," "intra-operative," "monitoring," "necessary," "procedures," "hernia repair"," "reduction of simple fractures," "large joint dislocation," "colonoscopy," "tolerate," "cardiorespiratory function," and "ability to respond purposefully." His testimony related to vagueness was unpersuasive and not supported by the evidence. After reviewing the rule and considering the evidence, it is concluded that the Rule requirements are not unacceptably vague. The terms "adequate," "appropriate" and "purposeful" have standard meanings in the field of medicine. Likewise, the remaining medical terms in the rule are not unacceptably vague. Transfer Agreements and Staff Privileges: Subsections (4)(b) and (6)(b) Petitioners contend that the transfer agreement and staff privilege requirements found in the rule are vague, fail to establish adequate standards for agency decisions, vest unbridled discretion in the agency, enlarge modify and contravene the law, are arbitrary and capricious and not supported by competent substantial evidence. According to Subsection 455.517(4)(a), Florida Statutes, neither the Department of Health, nor the Board of Medicine may take any action: . . . that tends to create or maintain an economic condition that unreasonably restricts competition, except as provided by law. However, Subsection 458.331(1)(v), Florida Statutes, provides that the Board of Medicine may establish rule standards of practice for office surgery settings, including transfer agreements, in order for the Board to determine whether a licensed doctor, subject to discipline, has practiced beyond the scope of the law or beyond his competency level. Subsection (4)(b) of Rule 64B8-9.009, relating to Level II Office Surgery, states: Transfer Agreement Required. The physician must have a transfer agreement with a licensed hospital within reasonable proximity if the physician does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. Subsection (6)(b) of Rule 64B8-9.009, relating to Level III Office Surgery, states; Hospital Staff Privileges Required. The physician must have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. There is no transfer agreement or hospital privileges requirement for Level I Office Surgery. Historically, surgeries were typically performed in hospitals, and a large body of regulation has developed to ensure patient safety. As many types of surgeries moved into ambulatory surgical centers, a new body of regulation was developed to ensure health and safety in that setting. Over the past few years, surgeons have increasingly been performing many types of surgeries in office settings with varying degrees of regulation. Among the regulations ensuring safety in hospitals are requirements for an organized medical staff, and staff-developed rules to set criteria for appointment to the staff and delineation of staff privileges. These rules promote quality of care by providing a review of the qualifications of staff physicians. Decisions regarding medical staff privileges are a function of the medical staff of a hospital with support and final approval by the Board of Trustees. Often, national standards and demonstrated competence provide a guide in making medical staff privilege decisions. The medical staff credentialing process is a well-established, but at times, subjective mechanism for evaluating the qualifications of a physician. A transfer agreement is a contract between a hospital and an office surgeon, providing for the transfer and acceptance of a patient in an emergency situation. There is no law or regulation which requires a hospital to enter into a transfer agreement with any physician. In addition, there is neither specific nor consistent criteria for the contents of a transfer agreement. Some agreements are very detailed contracts and others are general. During the rule-making process, the Board received testimony regarding surgeons performing Level II as well as Level III Office Surgeries and the requirement of staff privileges and transfer agreements. The Board's stated purpose for the Rule requiring a physician to enter into a transfer agreement is to ensure that steps are taken in advance to care for a patient who experiences a complication during surgery which exceeds the level of care that can be provided in a given facility. However, there is no reliable evidence that transfer agreements improve the quality of patient care. In the rare event an emergency occurs in the office surgery setting, the emergency 911 is called and the patient is delivered to the hospital. The absence of a transfer agreement between the hospital and office surgeon does not delay or impede the patient's admission to the hospital and access to appropriate medical care. Under Florida law, a hospital is required to accept and care for a patient who requires emergency medical attention. At the hearing, Petitioners provided significant testimony demonstrating they have been unable to obtain staff privileges and transfer agreements from certain hospitals. The determination of whether to grant staff privileges and/or a transfer agreement is solely the hospital's decision. And the evidence demonstrated that the determination doesn't always depend on the qualifications and reputation of the physician and the resources and circumstances of the hospital. It is undisputed that hospital privileges and transfer agreements may be denied (or revoked) for reasons other than physician competence. The standards for obtaining privileges vary from hospital to hospital. In fact, during the rule-making proceeding, the Board initially approved a change in Level III office surgery to remove the requirement that the surgeon have staff privileges, and recognized that: Hospital staff privileges may be denied for reasons other than competency, and that other documented training is comparable demonstration of competency. Factors other than physician competence enter into the decision of whether hospital privileges or transfer agreements may be approved. For example, turf battles at hospitals and personality conflicts among physicians at hospitals have been considered. Moreover, some physicians have refused to proctor other physicians as a part of the credentialling process. In fact, in some hospitals, competing physicians vote upon the approval or denial of the application of an office surgeon's request for hospital privileges. The evidence further showed that a physician's staff privileges can be approved by the medical staff but denied by the board of the competing hospital. Physician competence to perform Level II office surgery procedures is determined by Subsection (4)(d) of the Rule, "Training Required." Under this provision, in order to perform Level II surgery, the surgeon must either have staff privileges for the same procedure, or must be able to document satisfactory completion of training, or must document comparable background training or experience. Nevertheless, a competent office physician who possesses the "training required" to perform an office surgery procedure is precluded unless the physician has received either a transfer agreement or hospital privileges for that procedure. The inability of a qualified office surgeon to secure a transfer agreement or hospital privileges will have a drastic impact on the physician's ability to perform office surgery. The physician's office surgery will be limited to Level I office surgery. The Rule's requirements for either a transfer agreement or hospital privileges for Level II surgeries and hospital privileges for Level III surgeries unreasonably enable a competing hospital to unilaterally refuse a transfer agreement and privileges to a qualified office surgeon for reasons unrelated to physician competence. It has the direct effect of terminating a physician's Level II and Level III office surgery practice, without regard to the fact that the physician otherwise meets the "training required" elements of the Rule. It is inconsistent, provides no objective, non-competitive based criteria evaluation and tends to create and maintain an economic condition that unreasonably restricts competition which is inconsistent with and contravenes Section 455.507, Florida Statutes. Barbara Dame (Dame), who is a risk management consultant provided further support. She testified that over the last two years, many of her very qualified physician clients have had applications for transfer agreements summarily denied. Ms. Dame does not get involved in obtaining hospital staff privileges for her clients. Conversely, Bill Bell, General Counsel for the FHA, testified that the Rule requirement for physicians performing office-based surgery to have transfer agreements has existed for a few years and he is not aware of any problems physicians have had obtaining such agreements. The evidence to the contrary is more compelling. Transfer agreements can be a tool for some hospitals to control competition for surgery sites. Office surgery sites compete with hospitals for patients. Dr. Brent Amey is the Vice President of St. Joseph's Baptist Health Care, and has been an emergency room physician since 1974. He is aware of instances involving "economic credentialing", and the denial of transfer agreements and staff privileges unrelated to competence, although not at hospitals with which he has been associated.
Findings Of Fact In December 1982,, Ambulatory Care filed an application with the Department to be granted a certificate of need to construct a freestanding surgical center in Duval, Florida, to provide surgical treatment which does not involve overnight confinement, i.e. ambulatory or outpatient. The approximate cost of that project is $1,994,280. The proposed facility would be approximately 11,300 square feet in dimensions and contain four operating rooms with attendant substerile areas and scrub areas; necessary recovery, preoperative and postoperative areas; waiting areas; lounges staff changing areas; a business office area and physician space. The particulars of the description of the facility are more completely addressed in the application which is part of Department's Exhibit 1. The specific surgeries to be performed in this outpatient setting have not been determined; however, Ambulatory Care would anticipate proceeding on a basis similar to that of a freestanding ambulatory surgery center in Lexington, Kentucky, allowing for any differences in the two communities which might provide a different surgical mix by type. Information pertaining to that center was provided through the testimony of Dr. Edwin Nighbert, Transcript Pages 137-193. A further description of possible surgeries to be performed in the facility may be in the Department's Exhibit 1 through the Omission's Response of the applicant in an Appendix to that response numbered 1 entitled, "Types of Surgeries performed in an Ambulatory Surgical Facility." The surgeries to be performed are elective in nature and allow the patient to be discharged the same day of the procedure. The characterization of the facility as freestanding means that it is self-contained and not dependent upon other facilities in its normal operation. The exact location of that facility has not been established in that the purchase of property has not been concluded; however, Ambulatory Care intends to build the center in the Riverside area of Jacksonville, Duval County, Florida, as described by drawings and maps in the Omission's Response referred to before. Construction in this area would place the facility in the immediate vicinity of Saint Vincent's and Riverside Hospitals, which facilities also serve patients who undergo ambulatory surgery on an outpatient basis. Other hospitals in Duval County provide outpatient surgery, as more specifically described in latter portions of this Recommended Order. Following review, the Department issued a certificate of need for the project in its entirety, effective December 29, 1982. This action led to Petitioners' timely challenge to the proposed agency action. The Department simultaneously approved a certificate of need for another freestanding surgical facility in Duval County, Surgical Services of Jacksonville, Inc., with proposed expenditures of $2,500,000 and a plan to provide four operating rooms. That latter surgical center has not been challenged on the issue of the grant of its certificate, through protest from local hospitals. With the addition of Surgical Services and Ambulatory Care, outpatient surgery would be performed in Duval County in hospital settings, the freestanding centers, and physician's offices. The hospitals and Ambulatory Care are expected to provide the same surgical procedures either on an outpatient basis or inpatient basis. Saint Vincent's is a hospital which is owned by the Daughters of Charity, a religious order within the Catholic Church and is a nonprofit corporation. Riverside is a nonprofit hospital. Other hospitals in the area providing outpatient surgery at present or in the immediate future are Methodist Hospital, Jacksonville General Hospital, University Hospital, Baptist Medical Center, Memorial Medical Center, and Saint Luke`s Hospital. None of the hospitals referred to have freestanding outpatient surgery units, meaning all procedures provided by those institutions are hospital based. There being no rules promulgated in keeping with Section 381.494, Florida Statutes, related to the establishment of a methodology for considering the question of need for ambulatory surgical centers in Florida, the parties on this occasion attempted to establish a record basis for determining the need question. In this endeavor, objective and subjective observations and predictions were offered. Similarities and dissimilarities between hospital- based outpatient surgery centers and freestanding surgery centers were discussed and the relative merits of those sites ware debated. Given the novelty of this comparison in Florida, determination of need in the ambulatory surgery realm is less than an exact science. To accommodate this situation, factual determinations are based upon those elements of proof which tend to best describe the Duval County circumstance pertaining to the question of need for ambulatory surgeries at present and in the near future, with particular emphasis on the applicant's request for certificate. To begin, there is the issue of what constitutes a surgery for statistical purposes. In the State Agency Action Report related to the fiscal or calendar year reporting of procedures performed by Duval County hospitals ending in 1982, reference is made to the number of impatient and outpatient surgical procedures. There is uncertainty about some of the outpatient procedures reported, whether they are best described as surgical or diagnostic. As example, in Ambulatory Care's Omission's Response request it included certain procedures such as cysto which by exhibit were under a surgical heading. Subsequently, the applicant argued in the course of the hearings that these proceedings were diagnostic in nature and not surgical. One physician who testified believed that a cysto could be considered a surgery. Opinion was expressed that any procedure reported for insurance purposes as surgical should be accepted as such, even if primarily diagnostic in effect. A hospital official believed that procedures that are primarily diagnostic in effect are not surgeries. Another contributing element in the dilemma is the possibility that some procedures might be considered surgical at times and diagnostic at others depending on the intended result. Moreover, the record is not clear on whether some of the inpatient procedures reported for the 1981-82 reporting period by the Duval County hospitals would involve procedures which might arguably be described as diagnostic and not surgical. There being no consensus among the practitioners and the health care planners on the question of what constitutes a surgery and given the existence of a known statistical base, making allowances for adjustments related to numbers of outpatient surgeries in the reporting year ending 1982 which was made in the course of the hearing and consistent with Appendix 1 to the Omission's Response offered by the applicant, all procedures are considered surgical for purposes of this review, with the exception of endoscopic procedures. This determination takes into account that the applicant has not specifically delineated those procedures which it intends to perform. On a similar topic, Duval County has been identified as the service area for the Ambulatory Care facility. It is that population base which the Department used in trying to identify the surgical use rate for all surgeries and ultimately for ambulatory surgery by measure of surgeries per thousand population. This calculation fails to take into account the fact that patients from areas outside Duval County, especially from the surrounding counties use the hospitals in Duval County. It was not established in the course of the hearing what percentage or number of those patients from those outside areas were in the hospital for purposes of undergoing inpatient or outpatient surgery. Nonetheless it can be assumed based upon the facts presented that some portion of those patients did receive surgery thereby increasing the number of persons in the population base who underwent surgeries and decreasing the number of surgeries per thousand population. Moreover, the modification of statistics presented in the course of hearing to more correctly reflect the number of outpatient surgeries done in the reporting periods 1981-82 suggests that the total number of procedures was around 64,600, not the 68,000 plus first thought when the action report was prepared and the Department made its calculations. This change alone would reduce use rate for surgeries per thousand from 118 to 112. Having in mind a necessary adjustment in the population base to account for patients outside Duval County who receive surgery as well as adjustment in the outpatient surgery statistics in the 1982 reporting period, somewhat less than 112 surgeries per thousand could be expected. According to the applicant, the national experience has been an expectation of 55 to 90 surgical procedures per year per thousand population as a planning guideline. Those projections made as a result of research and data gathered are accepted as establishing the base from which more precise estimates may be made. In view of the national experience and the adjustments that are needed in the initial projection of the Department that 115 surgeries per 1,000 population would be the experience, 110 surgeries per 1,000 population is found to be a reliable figure both in 1982 and the succeeding years to include the critical years of 1985 and 1986, for Duval County, Florida, surgical procedures. This finding acknowledges the fact that 97 percent of the residents of Duval County seek their health care in Duval County. In trying to determine what percentage of all surgeries will be ambulatory or outpatient in the critical years 1985 and 1986, considerable testimony has been offered. That testimony tends to establish a potential for outpatient surgeries in the range 15 percent to in excess of 40 percent. During the reporting period for which data is available, as many as 15 percent of the surgeries performed in the Duval County hospitals have been performed on an outpatient basis. The Department has taken a median fraction or number between the extremes of 15 percent and 40 plus percent and anticipated 29 percent of all surgeries to be ambulatory surgeries in the years 1985 and 1986 in Duval County. In consideration of the dramatic increases in the number of outpatient surgeries being performed in local hospitals within the last two or three years, and the continuing improved reimbursement environment for those surgical procedures performed on an outpatient basis, 29 percent is a reasonable policy choice for making the projections. Based upon an analysis of the facts presented, it is not safe to assume that the number of outpatient surgeries performed in Duval County for its patients in the years 1985 and 1986 will approximate the 40 percent experience found in other communities outside Florida. The Department in its calculations has utilized mid-range projections of the University of Florida, BEBR, population studies showing a population in Duval County in 1985 of 387,500 and in 1986, 590,480. This midrange choice is sound. Employing the technique used by the Department, the following predictions are arrived at in terms of expected outpatient surgeries in Duval County in 1985 and 1986: 387,500 total populations x 110 procedures per thousand = 1,000 64,525 total procedures x .29 percentage of outpatient = 18,741 outpatient surgeries in 1985 * * * 390,480 total populations x 110 procedures per thousand = 1,000 64,953 total procedures x .29 percentage of outpatient = 18,835 outpatient surgeries for 1986. Who is to provide those outpatient surgeries in 1985 and 1986? In answering that inquiry, in 1981, excluding endoscopic examination, area hospitals performed 6,450 outpatient surgeries. This number increased to 9,527 in 1982 and based upon statistics provided for the first quarter of 1983 that number would approximate 11,000 outpatient procedures in 1983. This growth pattern in those reporting years reflects substantial increases in the delivery of health care related to outpatient surgeries; however, an extrapolation of percentage increases over the intervening year 1984 and into 1985 and 1986 does not give a reliable approximation of the level of outpatient surgeries to be provided by the several hospitals. Neither does the estimate by the Department that the increase in surgeries performed in the hospitals shall be only to the extent of the increase in population in Duval County in the intervening years. Therefore, the question of available capacity in the years 1985 and 1986 is considered on the basis of an inventory or audit of outpatient surgical suites which may reasonably be expected to provide outpatient surgeries in 1985 and 1986 based upon the selection or a utilization rate for those operating rooms. The applicant has initially indicated in its application that 1,200 ambulatory cases could be dealt with in one operating suite on an annual basis. Initial testimony of one of the applicant's witnesses, Andrew Miller, at transcript page 460, was to the effect that the range 1,200 to 1,250 cases approached the capacity for a single dedicated operating room performing outpatient surgery. In rebuttal testimony, Miller recanted and indicated that 1,300 cases per operating room was not a reasonable estimate for hospitals in Duval County. He suggested the use of lower figures, perhaps as low as 1,000 procedures per room. In the face of the evidence, it is determined that for purposes of this review 1,100 procedures per operating room are an acceptable approximation. Utilization of this number takes into consideration differences in the length of procedures, scheduling and turn-around time in the preparation of the operating suite for a subsequent procedure. By dividing 1,100 procedures into the 15,741 projected outpatient surgeries in 1985, there would he a need for 17 operating suites in that year. Realizing that same process of division against the 19,536 projected ambulatory surgeries in 1986, 17 plus surgery suites would be needed. At the point of hearing, there were 15 ambulatory surgery suites in the hospitals in Duval County, excluding endoscopic rooms and those rooms in which inpatients and outpatients were operated on. Eight of those rooms had capability of general anesthesia. St. Luke's, in the move of their hospital, would add two additional ambulatory surgery suites, both of which would have general anesthesia capability and both of which are under construction. The freestanding ambulatory center, Surgical Services of Jacksonville, Inc., would bring the total to 21 operating rooms with its four additional surgery rooms with general anesthesia capability. With inclusion of the St. Luke's and Surgical Center of Jacksonville, a total of 14 of the 21 operating rooms would have general anesthesia capability. This does not take into account the high number of outpatient surgery procedures which are being performed at Baptist Hospital in rooms which have an inpatient and outpatient mix, nor does it take into account future plans of area hospitals to increase their outpatient surgery capacity, which would provide even greater capacity for outpatient surgery. In summary, there is more than enough capacity to perform needed outpatient surgeries in Duval County in 1985 and 1986. Ambulatory Care and the Department have referred to the cost savings to the individual patient being treated and to the overall patient community should the Ambulatory Care Surgical Center be opened. If there was a demonstrated need for that center the proof tends to bear out the savings to the individual patient and arguably to the patient community as a whole. However, on this occasion, given the fact that the addition of Ambulatory Care's operating suites would bring the total to 25 operating rooms against the need for 17 plus operating rooms, the cost benefits to the individual patients being treated in the applicant's facility and the patient community at large, would not be realized. To the contrary, the inordinate duplication of services that would be experienced with the addition of the applicant's facility would tend to drive up health care costs in Duval County. Additionally, the applicant cannot be expected to survive financially in the overcrowded health delivery environment described in this paragraph. The innovative nature of a freestanding surgery center in matters such as ambience, related to the psychological well being of patients, especially younger patients and potential efficiency of operation of the applicant's surgical center are not sufficient to redeem its request for certificate in this instance. In a related vein, modifications to existing plans in the hospitals and the inconvenience occasioned by those adjustments are not such that those circumstances may be expected to impede the steady progress of increased outpatient ambulatory procedures in those hospitals and make them less than a viable alternative for performing the needed procedures in the 1985 and 1986 periods. Any competitive influence to be fostered by the addition of Ambulatory Care's facility would not be beneficial. Sufficient competitive influence is already present to promote quality care and cost effectiveness. Finally, if trends in outpatient surgery, particularly to be performed under general anesthesia increases beyond the predictions indicated, there is sufficient capacity in the hospitals to accommodate that eventuality by constructing new outpatient surgical suites or by conversion of inpatient surgical suites to perform outpatient surgeries to include ancillary space. This can be accomplished without having to resort to an application for certificate of need, given the $695,000 exemption or exclusion from the certificate of need review process. In view of the overburden that would be created in ambulatory surgeries by the additional capacity of the applicant, provision of needed construction of facilities is being met and can be met in the future in a less costly way then suggested by the applicant. On this occasion, the hospitals can provide more cost effective facilities. Ambulatory surgery is available and accessible in local area hospitals within Duval County in an appropriate and adequate setting. That service does not exclude any patient. Though not needed Ambulatory Care's contemplated facility addresses those contingencies set forth in this paragraph, with one proviso. That matter pertains to the fact that Ambulatory Care shall provide its services to all residents in the service area without regard for physical condition or financial standing, premised upon the willingness of the treating physician to admit those patients to the facility for treatment and subsequent screening to be done by the staff of Ambulatory Care to determine the appropriateness of that setting to achieve the surgery. This will cause a certain number of potential patients to receive their surgery in a hospital environment.
Findings Of Fact Manatee Eye Clinic owns land adjacent to its existing offices and in close proximity to Manatee Memorial Hospital, on which it proposes to construct a freestanding ambulatory surgery center for ophthalmic surgery. On December 13, 1983, Manatee Eye Clinic filed an application for a certificate of need with the Department of Health and Rehabilitative Services (HRS) for approval of a capital expenditure in the amount of $627,640 for construction of a freestanding ambulatory surgery center for ophthalmic surgery. On April 27, 1984, Petitioner received written notice that the Department had denied the application. Manatee Eye Clinic consists of five practicing ophthalmologists in Manatee County, each of whom are [sic] duly licensed and provide quality ophthalmic care in the area. Manatee Eye Clinic, and the members thereof, have available sufficient resources, including health manpower, management personnel, as well as funds for the capital and operating expenditures for the project. Petitioner's proposed medical facility would be constructed in a sufficiently cost-effective manner and makes adequate provision for conservation of energy resources and incorporates efficient and effective methods of construction. Should this certificate of need be granted, Manatee Eye Clinic will accept Medicaid, Medicare, third-party pay, private pay, and charity care. The relevant service area for the proposed facility is Manatee County. The five ophthalmologists at MEC perform approximately 1,200 eye surgeries per year involving cataract removal and lens implant. At present all of these surgeries are performed at Manatee Memorial Hospital. The founder of MEC, Dr. Robert E. King, has twice served as chief of surgery at Manatee Memorial. He is presently a director on the board of directors of the company that recently purchased Manatee Memorial Hospital and removed it from its former status of a not-for-profit hospital to its current status as a for-profit hospital. If this application is granted, Manatee Memorial Hospital will lose all of these patients. Cataract eye surgery, as it is performed today, is ideally performed in an outpatient surgery setting. The five ophthalmologists currently perform an additional 600 outpatient surgical procedures per year in the existing clinic. These procedures would be performed in the freestanding surgery facility if this application is approved. Manatee Memorial Hospital is located one city block from MEC. L. W. Blake Memorial Hospital, some seven miles from MEC, has five operating rooms available for outpatient surgery but is not currently used by any of the doctors at MEC. Additionally, Ambulatory Surgical Center/Bradenton was licensed in December, 1982. This facility has not been used by MEC doctors. During the latest reporting period, 1983/1984, Manatee County and the Ambulatory Surgery Center performed the following procedures; Hospital Inpatient Outpatient Total L. W. Blake Memorial Hospital 8,800 2,752 11,552 Manatee Memorial Hospital 6,766 1,654 8,420 Ambulatory Surgery Center -- 1,525 1,525 TOTALS 15,566 5,931 21,497 (Exhibit 19) There is no shortage of operating rooms in Manatee County available for outpatient surgery. Petitioner's primary argument against using the operating rooms at Manatee Memorial Hospital are: operating room nurses are rotated and this results in nurses not being as well qualified as they would be if their duties were limited to ophthalmic surgery; eye surgery is generally elective and such surgery may be bumped from a scheduled operation by emergency general surgery; the patients are generally older than 65 and are less comfortable in hospital surroundings than they would be at an outpatient surgical facility; access to the ambulatory surgical center would be easier for these elderly patients than is access to the existing hospitals for the same outpatient surgery; the hospital charges for the outpatient surgery are approximately twice the charges proposed by Petitioner; and Medicare will pay 100 percent of the charges in a freestanding surgical facility (up to a maximum) but only pays 80 percent in a hospital setting, thereby making the use of a freestanding facility cheaper for the patient and for Medicare. MEC doctors currently use their own scrub nurses during eye surgeries performed at Manatee Memorial Hospital leaving only the circulating nurse to be provided by the hospital. No incident was cited wherein one of Petitioner's patients was "bumped" from a scheduled operation. The complication rate for cataract surgery has dropped from 10 percent to 0.1 percent in recent years as surgical procedures have improved. As proposed, the partnership owning MEC will erect and own the surgery center, will lease the equipment, most of which is presently owned by MEC, to the Petitioner; and the rent for the building will be a fixed amount per month plus 50 percent of the net operating profits of Petitioner. Proposed charges by the freestanding surgery center will be $904 per patient (for cataract removal and lens implant) This does not include the surgeon's fee. There are no methodology rules to determine need for a freestanding outpatient surgery facility. DHRS has consistently determined need for ambulatory surgery centers by taking the most recent number of surgical procedures performed in all inpatient and outpatient facilities in the county and dividing it by the county's base population for the latest year, here 1983. This gives the rate of surgeries per 1,000 population for the latest year for which statistics are available and is projected forward to the second year of operation (here 1987). The same is done for outpatient surgeries. DHRS uses the figure of 29 as the percentage of surgeries that can be performed in an outpatient setting to determine the need for outpatient surgery facilities in 1987. From this is subtracted the number expected to be performed in existing hospital and freestanding outpatient facilities to determine net need through 1987 for freestanding outpatient facilities. Applying this procedure, to which Petitioner generally concurs, except for the 29 percent factor, the following need is shown. The 1983 population of Manatee County is 162,997. 21,497 surgeries performed in 1983 x 1000 4 162,997 131.9 surgeries per 1000 population. The 1987 projected population of Manatee County is 182, 120. Multiplying this population by 131.9 per 1000 equals 24,061 surgeries expected to be performed in Manatee County in 1987. HRS estimates that 29 percent of these surgeries could be performed in an outpatient setting in 1987. Multiplying 24,051 by .29 equals 6,978 outpatient procedures possible. In 1983 there were 4,406 outpatient surgeries performed in a hospital setting in Manatee for a rate per thousand of 27. Multiplying this rate by the projected population for 1987 yields 4,931 outpatient surgeries that can be performed in a hospital setting in 1987. Subtracting from this number the projected outpatient surgeries to be performed in a hospital setting in 1987 (6,978 - 4,931) shows 2,047 to be performed in a freestanding facility. Ambulatory Surgery Center performed 1,525 procedures from June, 1983, to May, 1984. When this is projected to 1987, Ambulatory Surgery Center is expected to perform 1,715 surgical procedures. Substracting this from 2,047 leaves 332 procedures as a net need through 1987. This is below the pro forma break-even point of Petitioner and indicates the project is not financially possible. The 29 percent factor was obtained from American Hospital Association report of 1981. In 1981, 18 percent of the total surgeries were done on an outpatient basis while it was estimated that 20 to 40 percent of all surgeries could be performed on an outpatient basis. DHRS averaged the 18 percent and the maximum of 40 percent to arrive a mean of 29 percent to project need for outpatient surgery facilities. The latest figures from the American Hospital Association report is for 1982 and this shows the latest percentage of surgeries performed on an outpatient basis to be 20.8 percent. If this figure is averaged with 40 percent, the mean would rise to 30.4 percent. This is the percentage Petitioner contends should be used. Using this figure, the outpatient surgeries possible in 1987 would rise to 7,315 and a need for 669 procedures would exist in 1987. This would meet the higher break-even number presented by Respondent of 556 procedures for the second year of operation. It is noted that the experts' estimated surgical procedures that could be performed in an outpatient setting varied from 20 to 40 percent. In arriving at the 29 percent used DHRS averaged the latest actual percentages available in 1981 with 40 percent to obtain an arbitrary figure of 29 percent to use in calculating need for outpatient facilities. It is further noted that between June of 1983 and May Of 1984 Manatee Memorial Hospital performed 1,654 outpatient surgery procedures and 6,766 inpatient surgery procedures (Exhibit 14) and Blake Memorial Hospital performed 2,752 outpatient surgery procedures and 8,800 inpatient surgery procedures (Exhibit 15). Accordingly, 23.8 percent of Blake's surgery procedures are done as outpatient surgery and 19.6 percent of the surgeries performed at Manatee Memorial Hospital are done as outpatient surgeries. If the 1,200 outpatient surgeries per year performed at Manatee Memorial Hospital by MEC had been removed during this period, the percentage of outpatient surgery would have been reduced to 6.3 percent for Manatee Memorial Hospital. No evidence was presented regarding the number of ophthalmic surgeries that were performed at Blake Memorial Hospital during this period. Regardless of the potential loss of outpatient surgery cases at Blake if this application is granted, the percentage of outpatient surgeries performed in a hospital setting in Manatee County is, according to the latest data available, 22.1 percent (combining Blake and Manatee Memorial). Using 29 percent of the total surgeries projected for 1987 in Manatee County to obtain an estimate of the outpatient surgery that can be expected to be performed in a hospital setting in 1987 results in a much higher figure than the current growth rate in outpatient surgeries would suggest. Accordingly, I find a 29 percent factor more credible than a higher percentage would be in forecasting need for outpatient surgical facilities in 1987. This conclusion is further supported by the fact that most ophthalmic surgery today is performed in an outpatient setting. This was not true only a few years ago. Accordingly, there can be little additional growth resulting from ophthalmic surgery procedures going from inpatient to outpatient procedures. As a consequence, future growth in outpatient surgery must come from other surgical procedures.
The Issue This case arises out of Orlando Regional Medical Center's objection to the issuance of a Certificate of Need to Surgical Services of Orlando, Inc., for the construction and operation of an ambulatory surgical center in Orlando, Florida. At the formal hearing, Orlando Regional Medical Center called as witnesses, Herbert E. Straughn, Norton Baker, Terry Weibley, Marlene Mariani, Michael L. Schwartz, Janice Smith, Richard Douglas Signer, Cathy Canniff Gillam, Jack Bradley, Barbara W. Miner, John Bozard and Stephen Haar. The Intervenor, Surgical Services of Orlando, Inc., called as witnesses, Steven Haar, Janice Smith, John Bozard, Michael Means, Jerry Senne, James Leveretee, Stephen Foreman, John S. Lord, Robert C. Klettner, Albert S. Bustamante, Pedro Diaz- Borden, Alberto J. Herran, Marianna Johnson, Richard Toole, Don Newton, Hank Gerken, Gordon Kiester, Leonard J. Levine, Rufus Holloway, Brenda Brinkman, Betty Barker, Wayne Deschambeau, Mark Richardson and Rick Knapp. Department of Health and Rehabilitative Services called as its only witness, Mr. Thomas Porter. Surgical Services of Orlando, Inc., offered and had admitted into evidence 33 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, the Hearing Officer reserved ruling upon SSO Exhibit No. 14 and that exhibit is admitted. Orlando Regional Medical Center offered and had admitted into evidence, 9 exhibits. At the formal hearing, Orlando Regional Medical Center was given permission to file a late-filed exhibit with Surgical Services of Orlando, Inc., and the Department having the opportunity to object to said exhibit. That exhibit has been filed as Orlando Regional Medical Center Exhibit No. 9 and consists of excerpts from the Department of Health and Rehabilitative Services file relating to this application. That exhibit is admitted. The Department of Health and Rehabilitative Services offered and had admitted into evidence one exhibit. A map of Orlando reflecting the location of the various hospitals in Orange County was admitted as joint exhibit 1. Subsequent to the formal hearing, each of the parties submitted proposed findings of fact and conclusions of law for consideration by the Hearing Officer. To the extent that those proposed findings of fact and conclusions of law are inconsistent with this order, they were considered by the Hearing Officer and rejected as being unsupported by the evidence or as unnecessary to the resolution of this cause.
Findings Of Fact Surgical Services of Orlando, Inc., (hereafter referred to as SSO), is a Florida corporation based in Orlando, Florida. The stock of the corporation is owned in equal shares by Steven Foreman, Dr. Rufus Holloway and Randall Phillips. Mr. Steven Foreman is a life underwriter and financial consultant, and real estate investor in the Orlando area. He is secretary and director of SSO. Dr. Rufus Holloway is an otolaryngologist in the Orlando area and is treasurer and a director of SSO. Randall Phillips is a hospital administrator presently employed by American Medical International, Inc. Orlando Regional Medical Center, Inc. (hereinafter referred to as ORMC) is an existing hospital located in Orlando, Florida. It is a not-for-profit regional tertiary care center with 1035 beds and 24 operating rooms. ORMC has two main divisions, the Orange Division and the Holiday Division and is presently constructing a new facility, Sand Lake Division, which will open sometime in mid 1985. The Sand Lake Division will have 4 operating rooms and 150 beds. Dr. Rufus Holloway and Steven Foreman have committed their personal resources to provide financial support for the complete development and operation of the applicant's proposed ambulatory surgical center. The facility will be constructed by a partnership, the Kaley Avenue Medical Partnership of Dr. Holloway, Mr. Foreman and Richard Toole, a citrus owner in the Orlando area, and will be leased to SSO. Two banks in the Orlando area have given commitments to provide the necessary financing for the proposed facility and start-up expenses. Pan American Bank has committed to provide a $2.5 million loan for the construction and equipping of the building and $750,000 line of credit. Dr. Holloway and Mr. Foreman, and the parties of the Kaley Avenue Partnership have sufficient financial resources to fulfill their commitments to the proposed project. The proposed building will be a one floor building containing 15,000 square feet. The total cost for the project will be $2,737,636. The building is to be constructed and equipped by the Kaley Avenue Medical Partnership and leased to SSO at $16 per square foot. The proposed site of the facility is on Kaley Avenue within two or three blocks of ORMC. Its service area will include all of Orange County. The facility will contain five operating rooms with only three of the rooms being completely equipped initially. These rooms will be used for general and local anesthesia. The remaining two rooms will be equipped as demand requires. The applicant has budgeted $743,000 for initially equipping the facility with an additional $160,000 required to equip the two remaining operating rooms. The equipment proposed by the applicant is adequate to perform those procedures which the applicant proposed to perform at its facility. In addition to the five operating rooms, the center will include laboratory, x-ray, administrative areas, as well as holding and recovery areas for the patients. The applicant projects a total number of procedures in the first year of 1,800 and 2,760 in the second year of operation. Based upon a Medicare utilization rate of 15 percent SSO projects an operating loss in the first year of $223,000 with the facility making a profit in the second quarter of the second year and generating a total profit of $766,000 in the second year. The projected break-even point is 2,448 procedures within a year. Projected revenues are based upon an average charge per case of $575. SSO also intends to accept Medicaid patients. Presently, Medicaid does not reimburse freestanding ambulatory surgical centers. Medicaid charges would be included as charity cases in the projected bad debt of 6 percent of gross revenues. Based upon an inflation rate of 8 percent per annum when SSO begins operation in January, 1986, its average charge per case will be competitive with other facilities in the area providing ambulatory surgical services. Medicare now reimburses 100 percent of the facility charges in a freestanding ambulatory facility and 80 percent for outpatient surgery in a hospital setting. Prior to opening, SSO will implement a marketing program directed to four different target groups: physicians, consumers (patients), employers and insurance carriers. SSO has retained a marketing expert who has prior experience in marketing ambulatory surgical care in Florida. Similar marketing has proven successful for other freestanding ambulatory surgical centers in Florida. SSO has budgeted $20,000 for pre-opening marketing expenses and $35,000 for the first year of operation. It is difficult upon this record to make a truly accurate comparison of outpatient surgical rates in existing facilities to the proposed average charge of SSO. ORMC presented evidence that the present average charge in ORMC and three other hospitals per outpatient case is as follows: ORMC $417.19 Florida Hospital $469.86 Winter Park $512.21 Orlando General $560.81 No average charges were presented into evidence for West Orange Hospital, Lucerne Hospital, or Brookwood Hospital. The evidence established that 8 percent is a reasonable inflation or increase rate for health care charges over the next two years. Applying an 8 percent inflation rate to the above average charges these charges for 1986, SSO's first year of operation would be: ORMC $486.61 Florida Hospital 548.04 Winter Park 597.44 Orlando General 654.13 In calculating its present average charge of $417.19, ORMC did not include those outpatient surgeries performed at the Orange Division which are charged at inpatient rates. A memo dated January 19, 1984, to John Bozard, ORMC Vice President for Finance, from Steve Horr, ORMC Assistant Controller/Reimbursement, reflects that Holiday Division had 484 outpatient surgical cases which are estimated to generate gross revenues of $228,547. This results in an average charge per case for the month of December 1983 of $472.20. It is concluded that in 1986 the SSO projected average charge of $575 will be competitive with those existing facilities in the Orange County area. There is presently no rule which contains a specific methodology for determining need for ambulatory surgery centers. HRS uses a methodology which is based upon policy but has not been proposed or promulgated as a formal rule. The present methodology utilizes the total surgery cases for the most recent 12 month period to determine a surgical utilization rate per 1,000 population. By separating inpatient and outpatient surgeries for the same 12-month period, a percentage ratio of outpatient surgery cases to total surgeries is established. Applying the utilization rate to future projected population, HRS then determines the total projected surgeries for future years and from this number calculates the projected outpatient surgeries which will be performed in existing facilities. Literature relating to ambulatory surgeries projects that 18 to 40 percent of all surgical procedures performed could be performed in an outpatient setting. In calculating total potential surgeries HRS utilizes 29 percent as the potential surgeries that can be performed in an outpatient setting. The 29 percent factor is the mean of 18 percent to 40 percent and appears reasonable in light of the fact ORMC, Holiday Division, Winter Park Memorial and Orlando General had outpatient surgery of 29.4 percent, 30.1 percent and 30.6 percent respectively for 1983. Applying the 29 percent factor to projected total surgeries, HRS calculates the projected potential ambulatory surgery for a given year in the future. Subtracting those outpatient surgeries which will be performed in existing facilities from the total potential outpatient surgeries provides the unmet need for outpatient surgical care. This need is reflected in total cases. In evaluating ambulatory surgical applications, HRS utilizes a two year planning horizon. It is projected that SSO would begin operation January 1, 1986, and therefore under the HRS methodology, 1986 and 1987 become the relevant years for the HRS methodology, 1986 and 1987 became the relevant years for looking at projected need. Using the methodology described above, HRS projects the potential number of outpatient surgical cases which could be performed in other than a hospital setting to be 7,203 and 7,347 for 1986 and 1987, respectively. HRS projects the break-even level of the SSO facility at 2,693 surgical cases per year. Subtracting the SSO break-even factor from 7,203 and 7,347 results in an unmet need even after the SSO facility is in operation of 4,510 and 4,654 surgical cases in 1986 and 1987. HRS calculated the outpatient utilization rate in existing hospitals in 1983 to be 15.3 percent. If the unmet need of 4,510 and 4,654 in 1986 and 1987 was met by these existing facilities, that utilization rate would increase to 24 percent or approximately 1 1/2 times the 1983 rate. The projected utilization for the SSO facility for 1986 and 1987 will constitute only about 20 percent and 30 percent respectively of the unmet need for outpatient surgery in those years. The applicant in projecting need used a five year planning horizon to project need for ambulatory surgical services in Orange County for the year 1989. Under SSO's methodology, an outpatient utilization rate of 30 percent, 35 percent and 40 percent was used to project the total potential outpatient or ambulatory surgeries for the year assuming a total surgical utilization rate of 101.45 cases per thousand. Using these assumptions, the applicant projected unmet need for ambulatory surgeries in Orange County in 1989 as: Percentage of Ambulatory Surgery Unmet Need 30% 6,357 35% 9,246 40% 12,136 Although the projected unmet need is somewhat lower than that projected by HRS, it does reflect a need for the SSO facility. The methodology used by ORMC utilizes what ORMC's experts described as the "excess capacity theory." This methodology is based upon the assumption that no need exists for an ambulatory surgical center until such time as all excess capacity in the existing operating suites in Orange County is utilized. Using this approach, ORMC contends that of the 79 total operating suites in Orange County, there are presently 39 excess operating suites available to perform outpatient surgery. By multiplying total number of hours per day per operating room times 260 days, ORMC calculates the total available hours of operation of an operating suite and by multiplying this number times the total number of suites, the total available hours or operating room time for a facility is determined. The total available hours is then divided by the average operating room time for all procedures performed to determine the total number of potential procedures. Using this approach, ORMC's expert opined that there is potential for 95,513 - 98,980 total surgical cases in the existing 79 operating rooms in Orange County These 79 rooms include the 4 new operating suites in ORMC's Sand Lake facility as well as the 4 suite in Florida Hospital's new freestanding ambulatory surgical center. Subtracting the total procedures of 47,712 from the potential capacity, ORMC projects an available excess capacity for growth of 47,801 to 51,268 surgical cases in Orange County. Also using total available hours, hours per average procedure and total hours required for procedure presently being performed, ORMC's expert calculated the number of operating suites presently required. By subtracting this number from the number of existing suites, the ORMC expert concluded that there are presently 39 excess operating suites in Orange County. Once the ORMC Sand Lake facility and the Florida Hospital Freestanding Ambulatory Center (FAC) open, there will be a total or 79 operating suites in Orange County. These are divided as follows: ORMC, Orange Division 14 ORMC, Holiday Division 10 Winter Park Memorial 10 Orlando General 4 West Orange 3 Lucerne 8 Brookewood 5 Florida Hospital 17 Florida Hospital, FAC 4 ORMC, Sand Lake 4 79 At present, ORMC, Holiday Division, is the only facility operating dedicated ambulatory surgical suites. There are no applications pending for dedicated outpatient facilities within hospitals or for a freestanding ambulatory surgical facility. No such applications have been filed for these types of facilities since the SSO application was filed. Each of the existing facilities listed above performs outpatient surgery to some degree. On August 16, 1982, Florida Hospital was issued a Certificate of Need to construct a freestanding ambulatory surgical center. That facility will contain four operating suites and is expected to begin operation in mid 1984. Once this facility is complete, Florida Hospital will not perform outpatient surgery in its 17 other suites, except when special equipment which is available only in those suites is required. Outpatient surgery at Winter Park Memorial and Orlando General now comprises approximately 30 percent of the total surgeries performed at those facilities. Lucerne Hospital operates no separate ambulatory surgery unit and favors SSO's application. ORMC has been performing outpatient surgery for over 20 years. However, the specific facilities in which outpatient surgery has been performed have changed during this period of time. Prior to August 1979, outpatient surgery was performed at the Five North unit in the Orange Division as well as at the Holiday Division. At that time, Orange Five North was closed for renovation and outpatient surgery was concentrated in Holiday One East. In October 1981, an outpatient surgery review committee was established by ORMC to examine more efficient ways to conduct outpatient surgery and to improve utilization of certain departments at the Holiday Division. The end result was a decision to concentrate outpatient surgery at ORMC in one designated unit to be known as Outpatient Day Surgery ("ODS"), and to provide a financial incentive for physicians and patients to utilize the unit. One of the primary reasons for concentrating outpatient surgery in Holiday One East was the inefficiency and increased cost of staffing the units. Outpatient census counts were resulting in overstaffing the 3 to 11 shift. To encourage doctors and patients to utilize Holiday One East, ORMC reduced the rates for outpatient surgery in the ODS unit by approximately 40 percent. Although some outpatient surgery continues to be performed at the Orange Division the charge for such surgeries is at the inpatient rates rather than the reduced rates utilized by the ODS. The ORMC Board of Directors approved the capital expenditure to renovate the Holiday One East area into the ODS unit on September 20, 1982. The ODS unit was renovated at a cost of approximately $600,000, which was below the Certificate of Need threshold requirement. The ODS unit opened on November 28, 1983. The ODS unit is open Monday through Friday, and utilizes a ten hour day with general anesthesia administered to outpatients from 7:30 a.m. to 1:00 p.m. ODS patients use a separate and distinct entrance to the Holiday Division and have a designated parking area east of the hospital. There are sixteen semi- private holding beds and four recliner chairs located within the ODS unit. The average case load and length of stay are such that holding beds may be used for more than one outpatient per day. As a result of instances where there have been shortages of holding beds for outpatients, ORMC beginning April 2, 1984, established an overflow area of ten beds on the third floor of the Holiday Division. As of May 29, 1984, this overflow area had been utilized on three occasions. The ODS unit contains two dedicated operating rooms where only local anesthesia can be administered. Outpatient procedures requiring general anesthesia are performed in the eight general operating suites of the Holiday Division. These eight operating suites are also used for inpatient surgery. Outpatients are placed in the same holding and recovery areas where inpatients are held. The staff in these areas serve inpatients and outpatients. The ODS unit averages 15 to 16 outpatients per day. In 1983, outpatient surgery comprised 29.4 percent of the total surgeries performed at the Holiday Division. This was a slight increase over the 27.7 percent outpatient percentage for that same division for the previous year. Presently, the two dedicated local anesthesia rooms are being utilized approximately 40 percent of the time. The present utilization rate of the entire Holiday Division is approximately 50 to 55 percent to as much as 80 percent depending upon the particular day of the week. The 80 percent rate is attained on a regular basis at least once per week. ORMC has been issued a Certificate of Need for a children's hospital. As presently designed and approved, the construction of the children's hospital will require the demolition of Holiday One East where the ODS unit is located. It is uncertain where the ODS unit would be relocated. The master facility plan approved by the ORMC Board of Directors includes the construction of a freestanding ambulatory diagnostic center which will include ambulatory surgery. Depending upon the staff and its efficiency and the quality of care provided, a freestanding ambulatory center offers several advantages over outpatient units within hospitals. In such a freestanding facility, only outpatient surgery is performed and the staff and physicians, including anesthesiologists, can be specialized in outpatient surgery. In the freestanding facility, outpatients are not mixed with inpatients. A substantial portion of those patients utilizing outpatient surgery are well patients having elective surgery performed. By specializing in outpatient surgery only, overall operating costs are likely to be less and should result in reduced patient costs. In a hospital setting, there is on occasion a problem with "bumping" elective surgery for emergencies. This would not occur in a freestanding ambulatory surgery facility. Patients will have shorter waits in the facility and Medicare patients will be reimbursed 100 percent rather than the 80 percent reimbursed in a hospital setting. The 550 application is consistent with the applicable criteria enumerated in Section 381.494(6)(c), Florida Statutes and need for its facility exists in Orange County. Of the thirteen governing criteria, the parties have stipulated that the criteria contained in Subsections 6, 7, 10 and 11 of Section 381.494(6)(c), Florida Statutes, are not applicable to this proceeding. In addition, the parties stipulated that Subsection 1 of Section 381.494(6)(c), Florida Statutes, is not applicable to this proceeding to the extent that there is no applicable district health plan or state health plan pertaining to ambulatory or outpatient surgery.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is, RECOMMENDED That HRS issue a Certificate of Need to Surgical Services of Orlando, Inc., to construct and operate a freestanding, five operating room ambulatory surgery center in Orange County. DONE AND ENTERED this 2nd day of July, 1984, in Tallahassee, Florida. MARVIN E. CHAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 1984. COPIES FURNISHED: Douglas L. Mannheimer, Esq. CULPEPPER, TURNER & MANNERED 318 North Call on Street Tallahassee, Florida 32302-3300 Fred W. Baggett, Esq. ROBERTS, BAGGETT, LaFACE, RICHARD, & WISER P.O. Drawer 1838 Tallahassee, Florida 32302 E. G. Boone, Esq. P.O. Box 1596 Venice, Florida 34284 Steven R. Bechtel, Esq. MATEER, HARBERT, FREY BECHTEL AND PHALIN, PA P.O. Box 2854 Orlando, Florida 32802 P. Joseph Wright, Esq. MURRAH AND DOYLE, P.A. P.O. Box 1328 Winter Park, Florida 32790 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue Whether Respondent violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and, if so, what discipline should be imposed.
Findings Of Fact The Department is charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2003). Dr. Dangl, whose address of record is 3900 Clark Road, Suite F-1, Sarasota, Florida 34233, was issued Florida license number ME 71286. On or before September 25, 2003, Dr. Dangl's office was approved to perform Level II Office surgical procedures by the Department. In a Level II Office surgery, "the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation." Fla. Admin. Code R. 648-9.009(4). Patient J.R., a 38-year-old female, presented to Dr. Dangl on September 25, 2003, for the removal of existing breast implants and the placement of larger saline implants. The surgery was scheduled to take place in Dr. Dangl's office. The surgical team consisted of Dr. Dangl; Amanda Fortner, R.N.; and Bruce Crow. Ms. Fortner assisted Dr. Dangl in administering anesthetic agents and other controlled substances, and monitored J.R. during the procedure. Her duties included documenting J.R.'s vital signs and the types and quantities of medications that were administered. A cardiac respiratory monitor, a pulse oximeter, and a blood pressure monitor were devices used to monitor J.R. during the surgery. A cardiac respiratory monitor records the heart rate, respirations, and the sinus rhythm of the heart. The oxygen saturation in the blood is measured by the pulse oximeter, which is placed on one of the patient's fingers. Blood pressure is monitored by the blood pressure machine. Bruce Crow was the surgical technician. During the surgical procedure, he made sure supplies and surgical instruments were ready, maintained the sterile field, and assisted Dr. Dangl with the procedure. At approximately 9:15 a.m. on September 25, 2003, Dr. Dangl started an IV in J.R.'s left hand and administered the following medications: one gram of Rocephin, 20 milligrams of Reglan, 50 milligrams of Demerol, ten milligrams of Valium, 25 milligrams of Ketamine and Versed. Dr. Dangl gave the initial medications, and Ms. Fortner administered additional drugs pursuant to Dr. Dangl's orders. J.R. was given an additional 200 milligrams of Demerol. The last dose of Demerol was administered by Ms. Fortner at 9:50 a.m. J.R. was a small person, and, for her weight and size, it took an unusual amount of Demerol to get J.R. sedated. Versed and Valium are sedative hypnotics, which sedate patients and cause them to become sleepy. Demerol is an analgesic, a pain medication. These medications can decrease respiration. Ketamine is a dissociate anesthetic, which does not cause respiratory depression. J.R. was also given a Propofol drip IV to help keep J.R. asleep. Propofol is a general anesthetic which depresses brain cells. The Propofol was mixed with a saline solution at a rate of one 55 cc vial per 100 cc's of saline. Ms. Fortner prepared the solution, which was initially administered by Dr. Dangl until he got it to the rate that he wanted. Once the surgery started, he would tell Ms. Fortner to speed-up or slow- down the drip as necessary. Three bottles of Propofol were used during the surgical procedure. J.R. was also given two liters of oxygen during the procedure. An oral airway was inserted into J.R.'s mouth during the early stages of the procedure. An oral airway is a long device that is inserted behind the tongue and goes deep into the patient's throat. In order to tolerate an oral airway, the patient would have to be in a deep level of sedation. J.R. was awake when the medications were started. She continued to talk through at least half of the time the medications were being administered. At one point during the surgery, J.R. "moaned a little bit, but then went right back to sleep." During the surgical procedure, Dr. Dangl sat J.R. up approximately three times to check the symmetry of the implants. J.R. continued to sleep through these checks. During the last time that J.R. was brought to a sitting position at approximately 11:55 a.m., the pulse oximeter alarmed. Thinking that the device may have fallen off J.R.'s finger, Ms. Fortner checked the device and also checked to make sure that the oximeter was not on the arm on which the blood pressure machine was placed. The pulse oximeter was on the correct finger. Ms. Fortner advised Dr. Dangl that something was wrong. She turned up the oxygen and placed an Ambu bag1 over the oral airway which had been placed in J.R.'s mouth at the beginning of the case. Ms. Fortner started Ambu bagging J.R. At Dr. Dangl's direction, Ms. Fortner turned off the Propofol drip. However, J.R.'s pulse oximeter reading did not improve. Not wanting to break the sterile field, Dr. Dangl yelled at Ms. Fortner, "Don't make me come back there and help your ass." When J.R. still did not improve, Dr. Dangl broke the sterile field, pushed Ms. Fortner aside, and began to Ambu bag J.R. Dr. Dangl checked J.R. for a pulse, but was unable to find one. Ms. Fortner checked for a pulse and thought that she may have found a faint pulse. Dr. Dangl, hearing the receptionist in the hallway, called to her to get Michelle Purdy, another employee of Dr. Dangl. The receptionist went to get Ms. Purdy and came back saying that Ms. Purdy was on the telephone. Dr. Dangl told the receptionist to get Ms. Purdy. Ms. Purdy, who is not a nurse, came into the operating area and tried to find a pulse for J.R. Unfortunately, Ms. Purdy tried to find a pulse using her thumbs. After being corrected by the surgical team, Ms. Purdy attempted to locate a pulse in the brachial, then the femoral, and then the pedal pulses, but she was unable to find a pulse. After being unable to locate a pulse, Dr. Dangl instructed one of his staff to call for emergency medical services (EMS). While Dr. Dangl and his employees were searching for a pulse, the surgical technician asked for leave to begin chest compressions. Mr. Crow told Dr. Dangl that the heart rate monitor was flat lining, meaning that it showed no basic heart rhythm for J.R. J.R.'s skin was gray and her fingers were turning blue. Dr. Dangl told Mr. Crow to wait. Dr. Dangl instructed Ms. Fortner to give J.R. three milligrams of Atropine two times. Ms. Fortner complied with his orders, but J.R. still had not started to breathe again. Mr. Crow continued to request Dr. Dangl to allow him to start chest compressions. After the administration of the Atropine failed to revive J.R., Dr. Dangl allowed Mr. Crow to begin chest compressions. From a minimum of two minutes to a maximum six minutes2 elapsed between the time Mr. Crow first asked to do chest compressions and when he began to do chest compressions. While chest compressions were being administered, Dr. Dangl ordered Ms. Fortner to administer Epinephrine to J.R. While Dr. Dangl continued to Ambu bag J.R., Mr. Crow administered three cycles of chest compressions. A cycle is 15 chest compressions to two Ambu breaths. J.R.'s heart rate returned and J.R. developed tachycardia, which means a high heart rate. About the time that J.R. revived and became stable, the paramedics arrived. J.R. was breathing, had a heart rate, and had a pulse oximeter reading of approximately 98. Neither the paramedics nor Dr. Dangl or any of his staff checked J.R.'s pupils. When the paramedics arrived, the surgery was not completed. The paramedics informed Dr. Dangl that another EMS team was on the way. Dr. Dangl and the paramedics agreed that Dr. Dangl could finish closing and suturing the wound, while waiting for the other EMS team to come and transport J.R. to the hospital. The paramedics stayed for a short time in the operating area monitoring J.R.'s vital signs and then left to make copies of J.R.'s chart, leaving Ms. Fortner to continue the monitoring of the vital signs. While Dr. Dangl was completing the procedure, J.R.'s vital signs were within normal range. Ms. Fortner periodically checked J.R.'s breathing by placing her hand over J.R.'s mouth. After Dr. Dangl completed suturing the wound, the second team of paramedics came into the operating area to transport J.R. The paramedics examined J.R.'s eyes, which were fixed and dilated. The paramedics immediately intubated J.R. and took her to the hospital. While at the hospital, Dr. Dangl admitted to J.R.'s fiancée that he had given J.R. "a lot of medication for her body size and weight," but that he thought J.R. was metabolizing the anesthetic very quickly. J.R. never regained consciousness after she was transported to the hospital. She died several months later from hypoxic encephalopathy, which means low oxygen brain damage. On September 26, 2003, Dr. Dangl dictated a report of operation. His documentation of J.R.'s "cardiorespiratory event" is as follows: Immediately prior to closure, the patient experienced a cardiorespiratory event that required CPR and resuscitative efforts. The EMS was activated and assumed care of the patient upon arrival. At this time the patient had responded to the resuscitative effort, vital signs were stable and permission was given by EMS to complete closure of the incisions prior to transport. The incisions were closed in a layered fashion with 3-0 PDS II and 5-0 nylon. A sterile dressing was placed over the incision sites. The patient was entubated [sic] by EMS prior to transport and left the O.R. via ambulance for Doctor's Hospital Emergency Room. Dr. Dangl signed a document entitled, "Operating Room Record." The record contained a section in which the medications that were administered should have been listed along with the time administered, the dosage, and the method of administration. That section of the record contained the following, "see anesthesia record," in lieu of listing the medications. The anesthesia record which was prepared by Ms. Fortner did not list all the medications that were administered to J.R. such as the Atropine and Epinephrine. She did not list the amount of Lidocaine or Propofol that was administered. It should have been obvious to Dr. Dangl when he reviewed the anesthesia report, that it was not correct. When Dr. Dangl prepared the Report of Operation and signed the Operating Room Record, he should have included the medications which he ordered and which were not included in the anesthesia report. Both Dr. Dangl and Ms. Fortner were certified in Advanced Cardiac Life Support at the time of the surgery. Ms. Fortner is not an anesthesiologist, a certified registered nurse anesthetist, or a physician assistant. Based on the testimony of Ms. Fortner that three 50 cc bottles of Propofol were used during the surgery, Dr. Joan Christie calculated that the dosage of Propofol that was administered was between 160 and 170 micrograms per kilo per minute. In a normal patient, who has received no other drugs, 100 micrograms per kilo per minute would be a lot of medication. J.R. received between 160 and 170 micrograms per kilo per minute on top of the other drugs that had been administered to her at the beginning of the procedure. The Propofol was administered in excessive amounts. Based on the evidence presented, it is clear that J.R. went from a Level II to a Level III office surgery during the surgical procedure. She tolerated an oral airway, which she could not do under a Level II or Level I. She was not responding purposefully to verbal commands or tactile stimulation. When J.R. was sat up to check the symmetry of her implants, she did not wake up or otherwise respond. Although she did moan at one time during the surgical procedure, that did not mean that she was either at Level I or Level II. Dr. Dangl has had no prior disciplinary actions taken against him by the Department.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and revoking his license to practice medicine. DONE AND ENTERED this 23rd day of February, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 23rd day of February, 2005.
