Findings Of Fact At all times material hereto, the Respondent was licensed as a general physician in the State of Florida, having been issued license number ME0031490. At times pertinent hereto, Dr. Elkadi operated the "Akbar Clinic" in Bay County, Florida. His operation of the clinic consisted generally of performing medical practice of a general nature as well as practice as a general surgeon, including outpatient surgery. He also practiced at Bay Medical Center, where he treated patients admitted under the auspices of other physicians. Dr. Elkadi had no admitting privileges at Bay Medical Center. The Petitioner is an agency of the State of Florida charged with regulating and enforcing the medical practice standards and licensure standards embodied in Chapter 458, Florida Statutes, including the standards of practice involved in the dispute in this case. Ms. Eunice Stallings was a patient of the Respondent on March 19, 1985, on which date she came to his clinic. She was 70 years of age. After performing some tests and observing the results, Dr. Elkadi informed her that she suffered from gall stones. She filled out a form in his office indicating that she had previously had a tonsillectomy, an appendectomy, a lobectomy and a hysterectomy. The doctor mentioned that she could be admitted to the hospital for surgery or could use his clinic. She elected to stay at the clinic and have the surgery there on account of the greater expense she believed involved with a hospital admission. She did not have any discussions with Dr. Elkadi concerning possible complications or risks associated with the gall bladder surgery prior to the surgery. Her daughter, Ms. Ted Cowens, went to the clinic with her on the day of the surgery. She arrived shortly after 7:00 a.m. on that day. A clinical employee escorted Ms. Stallings to the room to have her change into a surgical gown. Dr. Elkadi had discussed earlier with Ms. Stallings the possibility of staying in a nursing home or something of that nature after the surgery, for recovery. She assumed that the clinic would make the arrangements for that recovery procedure. She was not informed that she might have to stay beyond 24 hours in the clinic's facility. She was not informed prior to the surgery that Dr. Elkadi had no admitting privileges to the hospital, if complications should arise necessitating hospital admission. Ms. Cowens remained at the waiting room from 7:00 a.m. until 2:00 p.m. of March 19, 1985, while her mother-in-law was undergoing the cholecystectomy (gall bladder removal). She saw her mother-in-law at 2:00 p.m. that afternoon and observed that she was attached to a heart monitor and was breathing oxygen with difficulty. Ms. Cowens inquired about the circumstances and was informed by a person who identified herself as a nurse that Ms. Stallings had run into a problem with her lung. She was having difficulty breathing at the time. Ms. Cowens observed a person who identified herself as "Joyce" acting as a nurse right after the surgery. When she returned at 5:00 a.m. the next morning on March 20 to the clinic to see her mother-in-law, Joyce indicated that she had been the sole person on duty with Ms. Stallings during the entire night. She also indicated she had tried to get another person to be on duty, but was unable to do so. Ms. Stallings at this time was still coughing and spitting blood and continued to do so until her transfer from the Akbar Clinic to Bay Memorial Hospital by the Respondent and Dr. Albibi, based upon the other doctor's admitting privileges, at approximately 5:00, on March 20, 1985. Charles Wheelahan is an investigator for the Department of Professional Regulation and interviewed the Respondent in his Panama City office. The Respondent gave him copies of medical records regarding the Stallings case and informed him that a small respiratory problem, involving slight lung congestion, had occurred shortly after Ms. Stallings' operation, while she was still a patient in the clinic. Dr. Elkadi informed the investigator that he had made application to be licensed as a "hospital," but that license application had been denied by the Department of Health and Rehabilitative Services (HRS) and that he was in the process of applying to be licensed as a "surgical center." He also informed the investigator that the nurse on duty with Ms. Stallings on the night of March 19-20, 1985, was Joyce L. Snow. She was a Licensed Registered Nurse in Great Britain, but was unlicensed in the State of Florida. The doctor, in response to a question from Investigator Wheelahan, informed him that he did not maintain any blood supply on the clinic premises, but could obtain blood from the county hospital if needed. In any event, he informed the investigator that only a minor blood loss was expected and actually experienced during the cholecysteotomy surgery and that it would have been anywhere from 20 to 100 cc's blood loss. The investigator also established that a person known as Olga Sutter, apparently an employee of the clinic, was also present and cared for Ms. Stallings during some of the time she was a patient at the Akbar Clinic. Dr. John L. Williams testified as an expert witness on behalf of the Petitioner. He is a Florida licensed physician and general surgeon and has been in private practice in Tallahassee since 1970. He is Board-certified in surgery and belongs to numerous medical societies. His primary practice emphasis has been in direct patient care. Dr. Williams reviewed the hospital and office notes concerning Ms. Stallings, which comprise Exhibits 5A and 5B in evidence. The medical records reveal that Ms. Stallings went into respiratory distress post-operatively, which ended up as acute congestive heart failure, for which she was treated. The doctor's and nurse's notes reflect that she had become short of breath and that her blood pressure fell and that she ultimately became cyanotic. Blood gas test results proved the fact of her congestive heart failure condition. Dr. Williams felt that, although the treatment was adequate in the end result, there should have been some contingency plans developed in advance for handling any disaster or crisis that arose involving the pulmonary edema or bleeding suffered by the patient. The medical records and notes and evidence of record do not reveal that the Respondent had any such contingency plans for handling crises developing from performing such surgery in an outpatient setting. The operation, as shown by Dr. Williams, would have been more appropriately performed in a hospital setting so that the patient would have the crisis-handling ability of the hospital systems and staff during her overnight stay. It was his opinion that, given the history of lung trouble, wheezing, scarring of the chest, as well as her age, that this type of surgery should not have been done in the outpatient setting. Dr. Williams' expert opinion is accepted. Dr. Paul Lahti is an expert witness for Respondent and a retired general surgeon from Michigan. He reviewed the records of the Stallings case and found nothing inappropriate about Dr. Elkadi's care of Ms. Stallings. He stated that the doctor's actions avoided a catastrophe. He also stated that same-day surgery is recognized in 48 states. He has not practiced medicine in Florida. He also has spent a substantial amount of time writing, lecturing and advocating the cause of same-day outpatient surgery. I find his testimony significantly colored by his somewhat partisan view, advocating that a broad range of surgical procedures be performed as outpatient same-day surgery. His opinion appeared based on that and on the fact that nothing inappropriate was determined by him to have been done by the Respondent in his care of Ms. Stallings in terms of the end result. Dr. Edward Woodward, a professor of surgery, from the University of Florida, was also Respondent's expert witness. He likewise found the care of the patient itself appropriate and did not feel the problems she experienced were clinically important. Dr. Williams, the Petitioner's expert himself, however, did not find the actual techniques of the treatment afforded the patient, including that afforded her after the respiratory and congestive heart failure crisis arose, to be inappropriate. The problem was, that it was substandard medical practice, as related above, to handle such a serious surgical procedure for a patient of her age and with her previous health history as an outpatient surgical case. Appropriate medical practice would have dictated that a patient such as this be hospitalized before such surgical treatment. Dr. Woodward, one of Respondent's experts, also felt that it was the surgeon's duty in a case such as this to anticipate problems that may occur during or after surgery. Thus, in this context, and because of his more thorough review of pertinent records, Dr. Williams' expert opinion is the more valid one and is accepted over the others. Expert Witnesses Four experts were called by the Petitioner and Respondent to testify and give expert opinion testimony concerning the nine patients related to Case No. 86-1327, which will now be addressed. Dr. John L. Williams, general surgeon and expert for Petitioner, testified that he reviewed all the cases, involving hospital charts and office notes and other records, in its entirety, spending more than 30 hours reviewing them. Dr. Millard Roberts, a gastroenterologist and expert for Petitioner, read all of the hospital and office notes, which are exhibits, and spent more than 50 hours reviewing them. Dr. David Skinner is Chairman of the Department of Surgery at the University of Chicago and an expert for the Respondent. He stated in his deposition that he read abstracts of the medical records, contained in Respondent's Exhibit 7 in evidence, sent to him by the Respondent. He did not compare those prepared abstracts with the actual medical records which Dr. Williams and Dr. Roberts had reviewed. See Respondent's Exhibit 6, pages 17-21. Dr. Skinner spent approximately seven hours reviewing abstracts of the records furnished him by the Respondent himself, Dr. Edward Woodward is professor at the University of Florida. He stated that he reviewed the hospital charts, but no office records concerning the patients involved. He also looked at the Respondent's attorney's summary of notes to supplement his factual basis for rendering an opinion. The evidence did not reflect what length of time Dr. Woodward spent reviewing this material.. The Surgical Procedure at Issue Fundoplication is the surgical procedure under question in the nine cases comprising Case No. 86-1327. This procedure is designed to prevent "reflux" or regurgitation of stomach contents from the stomach up into the esophagus. "Reflux esophagitis" is the chronic inflammation of the esophagus due to the reflux of gastric juices into the esophagus for various reasons. Reflux esophagitis, if severe enough, may cause scarring or narrowing in the esophagus. Reflux esophagitis is an indication to perform the surgical procedure called fundoplication in those cases in which reflux is due to an inherent weakness in the junction of the stomach and the esophagus. The most common symptom of reflux esophagitis is a substernal burning or discomfort after eating, which is commonly referred to as heartburn. A further symptom is regurgitation of food when the patient bends over or lies flat after large meals. Other less specific symptoms of the condition involve upper abdominal pain. Ruth Cooey is a 73-year-old female who complained of epigastric pain upon admission by the Respondent. The patient had a history of taking Tagamet and antacids for one year. One year prior to admission, an upper GI examination was done which revealed an esophageal hiatal hernia and a duodenal ulcer. Her past history included arthritis with a left total hip replacement, hypertensive cardiovascular disease and a total abdominal hysterectomy. Following her admission to the hospital, Dr. Elkadi entered the case, treating the patient with Tagamet and Regulon. The patient's history contained notes of recurrent epiastic pain, nausea, choking spells and heartburn radiating behind the sternum for several years. Shortly before hospitalization, peptic ulcer had been demonstrated, as well as a hiatal hernia, which the Respondent confirmed. A "Bernstein test" was then conducted. A Bernstein test is designed to reproduce "heartburn" in most cases. The results are not always accurate. The Bernstein test was done three days after admission, with negative results. The results were not noted by Dr. Elkadi in his summary, however. Dr. Elkadi performed an endoscopy with the distal esophagus being described as compatible with chronic esophagitis. There was a "small sliding hiatal hernia with intermedial reflux." The records also reveal a description of two shallow ulcers of three to four millimeters each, in the prepyloric area and a large pyloric channel ulcer, described as being eight to ten millimeters in diameter. Biopsies taken during endoscopy showed chronic esophagitis and revealed chronic inflammation in the prepyloric mucosa. Dr. Elkadi performed a vagotomy, a pyloroplasty, and a Nissen Fundoplication on or about June 8, 1983. Dr. John Williams, the Petitioner's expert, opined that the reflux this patient had experienced was due to the primary disease of pyloric channel ulcer, which can cause reflux and thus produce symptoms of heartburn. If she had an intrinsic weakness of the esophagastric junction, a primary indication for a fundoplication procedure, then she would have had the symptoms before she was 73 years of age and not just had them occur after she had the ulcer. It was Dr. Williams' opinion that fundoplasty, the surgical procedure at issue, was really not indicated in this case. The symptoms exhibited for reflux esophagitis, which would justify the fundoplication were not present in this case. The symptoms existing were likely due to the ulcer as opposed to esophagitis. The symptoms the Respondent listed which he felt showed reflux esophagitis were pain after meals (thirty minutes to an hour and relieved by antacid), heartburn, and the epigastric pain described by Dr. Zawahry in June 1981. It might be noted that Dr. Zawahry, at that time, did not note any choking, dysphagia (difficulty in swallowing) or substernal pain, which are indications for fundoplication. The documentation of those symptoms came from the Respondent's notes. Dr. Williams felt the written records from the charts at the hospital did not justify the need for the fundoplication which was done. Her primary problem was a peptic ulcer. The esophagasoopy did show some esophagitis, which is evidence that some material was getting into the esophagus from the stomach or digestive tract below, but that was caused by the ulcer disease. Dr. Williams indicated that the treatment noted on those written records was below appropriate performance standards for a reasonable physician under reasonable similar conditions and circumstances, as there was no indication that the symptoms exhibited indicated the need for the fundoplication surgery. Dr. Millard Roberts, a gastroenterologist and licensed physician in the State of Florida, is a private practitioner in Tallahassee. He was qualified as an expert witness for the Petitioner in the field of gasroenterology. He received his undergraduate degree from the University of Florida and his medical degree from the University of Miami Medical School. He has admission privileges at Tallahassee Memorial Regional Medical Center and Tallahassee Community Hospital and presently serves on the Medical Records Review Committee of both those hospitals. He has practiced for sixteen years and attends numerous conferences and training sessions within his field of gastroenterology to keep his knowledge and skills current. He formerly practiced in that field, as well as in internal medicine, in Dothan, Alabama, His primary emphasis has been on the symptomology of the patients, which he obtains by taking a history, a physical examination, performing certain studies and arriving at impressions after completing examinations and observing the results of tests or studies. The standard practice in the medical community for determining whether or not symptoms are properly documented in records is based on rules promulgated by the Joint Commission on Accreditation of Hospitals, which method was employed by most hospitals in the country in 1985. Dr. Roberts discussed the various symptoms of esophageal reflux disease, including heartburn, difficulty in swallowing or painful swallowing (dysphagia), regurgitation or reflux of material as high as the throat or mouth. The symptoms noted in the hospital chart of the Cooey case, in his opinion, were related to ulcer, rather than to esophageal reflux disease. There was an absence of symptoms such as heartburn, dysphagia, choking and substernal pain. These symptoms were not noted in Dr. Zawahry's reports. He only reported epigastric pain. Dr. Roberts stated that it would be expected to see the other symptoms of esophageal reflux disease he noted appear in the patient's previous medical records made by Dr. Zawahry. Dr. Elkadi's consultation report is the first time these symptoms are mentioned. Dr. Roberts also pointed out that the Bernstein test is commonly used to confirm reflux esophagitis, but in Ruth Cooey's case the test was negative. It was negative on June 5, three days prior to the June 8 surgery. Dr. Roberts found nothing in the record occurring between the date of the Bernstein best and the date of the surgery three days later to confirm the necessity for doing a fundoplication. He further established that there was nothing in the radiologist's report to indicate any tertiary contractions of the esophagus, which would indicate a motility disturbance, which would be a justifying symptom. Dr. Elkadi's note is the only record he saw which is in any way supportive of the surgery. Dr. Roberts stated that the lack of symptomology to justify the fundoplication led him to conclude that the level of care and treatment fell below that of similar physicians practicing in similar conditions and circumstances. The other surgical procedure (for ulcers) should have taken care of the symptoms that were exhibited in the record without the necessity of the Respondent doing the fundoplication. The Respondent's expert, Dr. Woodward, agreed that the hospital charts and records did not give a clear history of reflux esophagitis in this patient. He also felt it was inexcusable not to have the information from the office notes on the hospital charts. He himself had reservations about the performance of the Nissen Fundoplication in this case, but would not call it malpractice. Dr, Skinner, the Respondent's other expert witness, testified in his deposition that the operation was appropriate. Based upon their greater familiarity with the circumstances of this case, including their more extensive survey and consideration of the records involved and their more direct experience in gastroenterological practice and surgery, I accept the opinions of Drs. Williams and Roberts over that of Drs. Woodward and Skinner. Debra Crosby is a 28-year-old female with a history of morbid obesity. She was admitted to Bay Memorial under the Respondent's care with a history, over the past few weeks, of nausea and dyspepsia, which is epigastric distress after eating greasy, fried foods. She had a past history of acid indigestion. The Respondent immediately ruled out gall bladder disease, the patient having been admitted for abdominal pain as well. The secondary reason for admission was for "morbid obesity," to conduct a surgery to allow the patient to reduce her obese condition. Such surgery limits the intake of food and the ability of the intestines to absorb food to some extent. The patient had surgery to correct morbid obesity. That surgery is called a "Roux-en-y" gastric bypass. That surgery involves making a small pouch near the upper part of the stomach, bringing the small intestine up and attaching it to that pouch so that the patient is only able to eat a limited amount at a time. Dr. Williams opined that that was an appropriate procedure to use for "bariatric surgery," that is, to relieve obesity, although he himself prefers the "vertical bend gastric partition procedure." No gastroesophageal reflux symptoms were documented in this case. In any event, on the 22nd of July, shortly before surgery, the patient was vomiting and suffering epigastric distress. They performed a "GI series" or barium- assisted X-ray of the upper digestive tract. While the patient was actually in the process of vomiting, a small hiatal hernia was demonstrated. Because of the vomiting, they had to abandon the upper GI series test. It was postponed until the next day, at which time another upper GI series test showed normal with no sign of hiatal hernia. So no esophageal reflux condition was demonstrated, nor was there any significant indication of hiatal hernia, which can cause a reflux condition in the esophagus. An ultrasound test of the gall bladder established that there were no gall stones, and her gall bladder appeared normal. She then had surgery for the gastric bypass procedure and also had a fundoplasty. The fundoplasty or fundoplication involved suturing the anterior wall of the stomach pouch to the anterior wall of the esophagus on one side. Only one side of the stomach was sutured up, and Dr. Williams established that fundoplasties all should be characterized by a "wrap" of some sort of the stomach around the base of the esophagus. The manner in which the surgery was described in the Respondent's operation note does not reveal that he could possibly do the appropriate fundoplication wrap procedure in that manner, with only a partial wrap. Esophageal reflux disease usually disappears with weight loss. With surgery to correct morbid obesity, accepted medical practice dictates that reflux-correcting procedures (fundoplasty) not be done. The reduction of the obesity greatly relieves the problem of reflux, and the gastric bypass surgical procedure is effective in preventing reflux of bile and juices itself. In Dr. Williams' opinion, which is accepted, there were no specific symptoms showing a reflux condition. There were some nonspecific symptoms that could possibly have been attributed to reflux involving epigastric pain or acid indigestion. The nausea and vomiting could have been due to many causes, but Dr. Williams thinks most likely that she suffered from gall bladder disease in spite of the fact that she did not have any stones. So, her symptoms could have been due to gall bladder disease, just acid indigestion, obesity or reflux. There were no clear-cut symptoms to justify the anti-reflux operation, however, because the patient had no symptoms of reflux before she had an acute illness, which caused her hospitalization. She was simply morbidly obese and correction of that problem would solve also any reflux symptoms she may have been-having. In summary, the medical records of this patient, maintained by the Respondent, did not justify an anti-reflux procedure such as fundoplasty. In any event, Dr. Williams opined that the procedure that was done would not prevent reflux anyway, even though it was unnecessary. This is so because an appropriate wrap of the stomach around the esophagus was not done. So, as established by Dr. Williams, the partial wrap, fundoplication procedure was supefuous and should not have been performed. Dr. Roberts also reviewed the Crosby case and opined that the gastroesophageal reflux condition would disappear with weight loss, brought on by the Roux-en-y procedure. When the pressure within the stomach exceeds the pressure of the lower esophagus sphincter muscle designed to prevent the reflux or regurgitation, then reflux can occur. The obesity causes a thickness and weight on the abdominal wall which pressures the stomach. The increase in the intraluminal pressure of the stomach enhances the possibility that reflux will occur. Therefore, prevention of increase of intraluminal pressure of the stomach would decrease the likelihood of reflux occurring. The documented symptoms of esophageal reflux disease, such as heartburn, dysphagia, chest pain, chronic cough and epigastric pain were not present in this patient, with the exception of some heartburn pre-operatively. Dr. Roberts established that the written records for this particular patient do not justify, by symptomology recorded, the necessity of doing a fundoplication procedure. Dr. Roberts thus corroborated the finding by Dr. Williams that the treatment and care of this particular patient fell below accepted standards for reasonable physicians under reasonable similar circumstances and conditions, since the indications for the fundoplication procedure were not present in the patient's records. Dr. Skinner opined once again that he felt the operation was appropriate. Dr. Woodward, however, questioned the necessity of the repair of the hiatus hernia and the anti-reflux operation or fundoplication. He felt that with weight loss the reflux condition would disappear with the lessening of pressure on the stomach and that therefore it was probably unnecessary, although he did not go so far as to call it a situation of malpractice. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Patient Dorothy Kay was a 68-year-old female with a history of diabetes, cardiovascular disease and legal blindness. She also had some urinary and renal system dysfunction, with hyperemia. She was admitted by Dr. Kahn in June 1981 for abdominal pain, nausea and vomiting of one day duration. She had had three black bowel movements immediately before admission, but these were not tested for blood. Since her hemoglobin level was normal on admission and remained normal, Dr. Williams, in his testimony, discounted the possibility that she had gastrointestinal bleeding. She was thoroughly evaluated after admission, and her gall bladder proved normal. An upper GI examination showed a small hiatal hernia, but with no reflux, on June 15. Examinations of the kidney and a CAT scan of the abdomen were not remarkable, and a barium enema on the 22nd of June revealed some diverticulosis. She had a problem with constipation at this same time, which could have explained some of her complaints of abdominal pain, especially because the abdominal pain ceased after the barium enema, according to the nurse's notes. An endoscopy was performed on June 18 to examine the esophagus and stomach area. The esophagus showed some chronic inflammation. This can either occur as a normal occurrence or as a result of some disease process. This particular patient's history revealed that she had arthritis and had been taking a substantial dosage of Motrin, at 600 milligrams per day. Motrin is one of the drugs that can cause gastrointestinal and peptic symptoms. It can produce ulcers and bleeding. The patient had been maintained on this dosage of Motrin until two days before surgery, which is quite a significant dose. Dr. Williams also found that the abdominal pain was relieved upon administration of saline injections. H3, therefore, thinks the abdominal pain was most likely due to functional disease associated with diabetes and may well have been caused by the Motrin medication. In any event, there was no evidence in her history which would indicate that reflux esophagitis (the indication for a fundoplication procedure) was the cause of her pain. Even Dr. Elkadi's admission notes noted that her tenderness was more prominent in the lower abdomen than in the upper abdomen. The patient was operated on and had a needled biopsy of the liver and the fundoplication procedure, as well as a "lysis" of adhesions. The operation notes were not written until two months after the surgical procedures were done. Operative notes are customarily done at the time of surgery and on the same day if possible, so that the physician will not be as likely to forget details of the procedure as he would if they were dictated two months later. The operative notes on the fundoplasty procedure were done on August 19. The surgery was performed on June 25. Dr. Williams established that the records on this patient simply did not show symptoms of reflux esophagitis, an indication for the fundoplasty. The esophagoscopy was not valid evidence, standing alone, of reflux esophagitis, and that was the only possible suggestion that a chronic reflux condition existed. Dr. Williams established that the small degree of change observed in that procedure, due to reflux, was due to vomiting of the rather short historical duration occurring immediately prior to her admission. The Motrin medication she was taking could, itself, have caused her symptoms. The minimal chronic inflammation of the esophagus was not shown to be due to any defect in the gastroesophageal joint, but could have been due to any number of conditions in a diabetic, aged and infirmed patient like this and most likely was due to the recent vomiting, which is of undiagnosed etiology. Dr. Roberts referred to Dr. Elkadi's consultation of June 12, 1981, wherein he noted that the woman had been having abdominal pain for seven years, progressively worsening. Dr. Roberts did not feel that indicated reflux esophagitis. The reason he did not think so was because there was no mention made of any heartburn pain or difficulty in swallowing as to the upper abdominal area or chest area. There was also no mention in any of the notes or records that the patient was developing any strangling sensations or symptoms suggestions aspiration of gastric contents, bleeding or hemorrhaging, which would be suggestive of sever ulceration of the esophagus. Dr. Roberts agreed with Dr. Williams that this patient's records do not in any way indicate symptomology, clinical or otherwise, which would confirm a diagnosis of reflux esophagitis, indicative of a fundoplication procedure. Dr. Woodward, the Respondent's expert, also felt that the fundoplication was unnecessary. He found no history suggestive of reflux esophagitis and felt that such elective surgery in a person who was this sick, with diabetes and related problems, was a poor idea. He also found it unforgivable that the history was not more descriptive of the patient's problems and that the history concerning the patient's medication regime was not documented in the hospital chart. The doctor was opposed to the patient having this operation but, because of "mitigating circumstances" which he never fully explained in his testimony, would not call this a situation of malpractice either. In any event, based upon the testimony of Drs. Williams and Roberts and corroborated to some extent by that of Dr. Woodward it is found that Dr. Elkadi's treatment of this patient was inconsistent with quality medical care and fell below appropriate standards of practice for similar physicians practicing under similar conditions and circumstances. Agnes McNeil is a 42-year-old female with a history of depression, nausea, vomiting and abdominal pain. She was admitted to the hospital in October 1981 with approximately a six month history of abdominal distress and vomiting. A GI series was performed showing normal results and an upper gastrointestinal and endoscopy showed some esophagtis. There was also a finding made that she had a duodenal ulcer with some reflux. That finding was made October 31, 1981. She was admitted again on the 8th of March, 1982. On March 11, she had an "upper end endoscopy" and was said to have a hiatal hernia with reflux and duodenal ulcer, on the pylorus. The esophagus, however, was normal, and the GI series was negative once again. It showed no hiatal hernia and no reflux. She had surgery for the duodenal ulcer in the pyloric channel. The procedure done was a "highly selective vagotomy" which is done to inhibit the secretion of acid by the stomach. This is a rather new procedure and is not statistically as effective as some other procedures for the same condition. Additionally, the Respondent did a fundoplasty. The fundoplasty was not properly indicated, as established by Dr. Williams, because the significant changes in the esophagus which would indicate such a procedure were not present. The past reflux condition occurring in October 1981 was due to the acute ulcer condition. There had been no significant history of reflux prior to the onset of the peptic ulcer disease. If reflux was present, then the patient should have experienced some regurgitation upon bending over or waking up at night, as well as burning in the chest upon lying down at night, and none of this appeared in the record. A biopsy was done in this case which indicated acute esophagitis, and the patient had suffered severe weight loss, but this, in Dr. Williams' opinion, is related to the peptic ulcer condition and is justification for a vagotomy procedure, either the normal type or the new and somewhat controversial, highly selective vagotomy which Dr. Williams guardedly agreed with. In any event, however, he established that the fundoplasty was not ordered because the evidence of reflux esophagitis in the patient was directly related to the peptic ulcer disease and the procedure to effect a of that problem could be expected to alleviate the eophagitis. In any event, post-operatively, the patient still continued to have upper abdominal pain, nausea and vomiting. The obstruction in the pyloric area caused the reflux and caused the vomiting. The constant vomiting resulted in the inflammation or esophagitis condition. Pyloric channel ulcers cause obstruction which causes vomiting, and vomiting by definition is "reflux." The removal of the cause of the vomiting will also, over time, heal the esophagitis, without the necessity of a partial fundoplasty, as was done in this case. Dr. Roberts, in reviewing the McNeil patient records and notes, found that the upper GI series and the pathology in this particular case did not show significant evidence of reflux esophagitis. Three different "upper GI series" before and after she surgery, were interpreted as normal. His testimony, in effect directly corroborates that of Dr. Williams in establishing that the performance of the fundoplication as treatment in this case was below accepted standards of practice or a reasonable physician practicing under similar conditions and circumstances. Although he did not testify in his deposition that the Respondent fell below the standard and committed malpractice, Dr. Woodward, the Respondent's expert, also questioned and doubted whether the patient needed the Nissen. Fundoplication in view of the medical records he was given to review. Ms. Nguyen was a 77-year-old Vietnamese female at the time of her admission to the hospital by Dr. Kahn in December 1981. Her complaints were abdominal pain, nausea, vomiting, constipation, dehydration and fainting. She had been unable to urinate for approximately 24 hours prior to admission. These conditions are revealed by the notes, but the failure to urinate for approximately 24 hours is inconsistent with the dehydration symptom noted. In any event, she is a Vietnamese national and did not speak English. Communication with the Respondent, whose service she was admitted on, was difficult. It was thus difficult to get an adequate history from her, which made the history somewhat sparse. During her hospitalization, on December 19, Dr. Elkadi noted some "right upper quadrant tenderness." Dr. Elkadi had been consulted on the 18th of December and had noted at that time nausea, vomiting, right upper quadrant tenderness and constipation. Gall bladder X-rays showed probable gall stones or "sludge" in the gall bladder, and a GI series indicated a small hiatal hernia, without mention of reflux. An abdominal ulcer sound test was performed which showed sludge or small stones in the gall bladder. Gall bladder disease fit the physical findings of right upper quadrant tenderness, acute onset of nausea and vomiting and also the history of the patient not having a good appetite, being nauseated over the course of the year and losing a significant amount of weight. She only weighed 87 pounds upon admission. An endoscopy was performed, as a result of which Dr. Elkadi described the patient as having distal esophagitis, moderate erythema and edema, as well as a small hiatus hernia. A cholecystectomy was performed for removal of the gall bladder. There were no symptoms other than nausea and vomiting which would justify a finding that reflux esophagitis was present and that therefore anti- reflux surgery might be indicated. A small hiatal hernia was not significant, and there was minimal esophagitis shown by the endoscopy done immediately prior to surgery. What esophagitis evidence was present was due to the nausea and vomiting related to the gall bladder disease. Dr. Elkadi performed a fundoplication procedure anyway. Performance of a fundoplication is additionally risky for a person who is frequently vomiting, and the fundoplication was shown by Dr. Williams to be unnecessary in this case. The nausea and vomiting were not symptoms of reflux disease, but rather were symptoms of the gall bladder disease. The small hiatal hernia did not justify anti-reflux surgery in this case because that is frequently seen in older people and is not significant in itself. Additionally, although Dr. Elkadi's records showed that he removed a large gastric tumor, in reality that tumor was only one centimeter in diameter sitting on the surface of the stomach and was of no consequence in the patient's condition or related to any of her symptoms. The symptoms of right upper quadrant pain, nausea and vomiting, and the test results, justified the cholecystectomy (gall bladder) procedure, which is what Dr. Elkadi should have done and then stopped. He should have determined whether that alleviated the patient's symptoms, rather than doing the unnecessary fundoplication when the record did not reveal any significant reflux esophagitis indications, and since that procedure represents an additional risk to the patient. In summary, it was established by Dr. Williams that the records were not adequate to justify the fundoplication performed in this case. The performing of it unnecessarily constituted a failure to practice medicine with that degree of care and treatment required of physicians under similar circumstances. It is especially true in the case of a patient such as this, who is old and feeble at best. Performing an unnecessary operation on such a sick, 77-year-old patient increases the mortality risk somewhat and increases the post-operative morbidity risk significantly because the patient will not be able to "burp" any longer and can become subject to "gas bloat," as well as the risk of having difficulty swallowing because the "fundoplication wrap" might be too tight. The fact that it constituted malpractice to proceed forward with the unnecessary fundoplication is especially pointed up by the fact that Dr. Elkadi's own notes reveal that he was unable to understand the patient, who could not speak English, and thus was unable to get an adequate history. If the history is unclear because of a language problem and the doctor cannot understand the patient to make sure of the extent and nature of the symptoms, it is not reasonable to proceed with the operation, as opposed to trying to find an interpreter who can help the physician ascertain clearly what the symptoms are and what the indications for treatment are. Dr. Roberts, likewise, was unable to find any proof in the hospital records of the presence of any reflux esophagitis and felt that the fundoplication was unjustified. In fact, as he pointed out, Dr. Elkadi himself in his operative notes indicated that the limited history he was able to obtain from the patient was not specific enough to distinguish between gall bladder symptoms and gastroesophageal reflux symptoms. Dr. Roberts thus felt that the treatment of this patient fell below acceptable standards of a similar physician under similar circumstances. Dr. Woodward, the Respondent's expert, was unable to determine what was wrong with the patient and found that the hospital chart did not clarify it for him. The purpose of a patient history, according to Dr. Woodward, is to give a word picture of a patient's problem, and he found that the history, in addition to being inadequate, did not indicate any reflux esophagitis. He agreed with Drs. Williams and Roberts that the cholecystectomy was needed, but it was unlikely that the patient really needed anti- refluxsurgery (fundoplication). The additional operation, in addition to being unnecessary, added to the patient's mortality risk and post-operative morbidity. It has therefore been established that, as to this patient, the practice of the Respondent and his treatment of the patient fell below the acceptable standards for similar physicians practicing under similar conditions and circumstances. Rosey Peel was a 66-year-old lady admitted in May 1982 to Dr. Elkadi's service with a history of gastrojejunostomy, appendectomy, total abdominal hysterectomy, with associated adhesions. In October 1980, she had had a history of duodenal ulcer which was medically treated, as well as a history of stomach erosions and bowel gastritis treated medically in May 1981. In April 1982, she underwent an endoscopy, and the pathology report indicates the presence of chronic esophagitis and inflammation of the gastrojejunostomy. She had a history at this time of epigastric pain, nausea and vomiting. The endoscopy showed ulcers in the jejunum at the site of the gastrojejunostomy or the "rough equivalent to the pyloric channel." Thus, the patient had active peptic ulcer disease with related endoscopic evidence of bile in the stomach and in the esophagus. She underwent a vagotomy as a correction for the ulcer disease and a resection of the distal stomach, which disconnected the stomach from the duodenum in order to get rid of the problem of bile entering the stomach and causing the reflux esophagitis. The reconnection process was done in the form of a Roux-en-y procedure or gastric bypass, which has the effect of preventing the bile from entering the stomach. As opined by Dr. Williams, these procedures would alleviate her problem involving the ulcer disease, the reflux biliary gastritis and esophagitis. Consequently, she did not need the fundoplasty procedure, and it was unnecessary. The anti-reflux procedure did not have to be done, and the primary disease process, peptic ulcer disease, would have been alleviated by the Roux-en-y gastrojejunostomy and the vagotomy. Dr. Williams opined that when an operation like this that is unnecessary is done, then strictly speaking malpractice has been committed. He acknowledged, however, that it was possible to interpret her symptoms and records as indicating reflux biliary gastritis, which could have easily led the Respondent to believe that a fundoplication procedure could cure her problem. In fact, it was not necessary to cure the reflux problem she was having, as delineated above. In this particular case, standing alone, it might be said that, given the presence of reflux biliary gastritis and esophagitis, that a practitioner could make a good faith mistake in performing a fundoplication, rather than limiting the surgery to the Roux-en-y repair and the complete vagotomy. Dr. Roberts, after reviewing this patient's file, was unable to find symptomology in the record which would justify the fundoplication. The abdominal pain, nausea and vomiting, which had worsened over several months, were related, in his opinion as well as Dr. Williams', to bile reflux gastritis. Reflux in and of itself is not justification for surgery, especially when the patient is not complaining of chronic reflux esophagitis symptoms. The reflux can be due to other causes, as mentioned above, including the pyloric ulcer situation this patient suffered. He opined that the esophageal reflux situation and the delayed gastric emptying would have been relieved with just the procedures performed short of the fundoplication, as did Dr. Williams. Inasmuch as Dr. Williams felt that this single instance of performing the fundoplication, albeit necessary, could not by itself be called malpractice, since enough symptomology was present to lead a competent practitioner into performing it as a result of a good faith mistake, and since both Respondent's experts felt that the procedure was documented in this case, it cannot be found that this instance, standing alone, was gross or repeated malpractice. It has, however, been proven that the procedure was medically unnecessary. Considered together with the other unnecessary surgeries discussed in these Findings of Fact, however, the overall pattern is one of medical treatment which does not measure up to the standards of reasonable physicians performing such practice and treatment under similar conditions and circumstances. Ms. Rosey Smith is a 63-year-old female with a history of total abdominal hysterectomy, right nephrectomy and adhesion laparotomy, both of which procedures were performed in 1950; cholecystectomy performed in 1962; and hiatal hernia repair performed in 1980. She was admitted to the Respondent's service in 1981 complaining of epigastric pain. An endoscopy performed revealed moderate, chronic esophagitis, but the pathology report failed to confirm esophagitis and was interpreted as being without evidence of inflammation of either the esophagus or gastric mucosa. She was admitted by Dr. Kahn and subsequently consulted by Dr. Elkadi. She had had a Nissei Fundoplication for reflux esophagitis in November 1980. She was admitted again on this occasion in September 1981 with nausea and epigastric pain. Since her surgery in 1980, she has been unable to eat well because of fullness and pain after eating. She had upper gastrointestinal pain upon admission, and the endoscopy performed showed that she had a slight amount of esophagitis. However, biopsy of the stomach and the esophagus were normal. The upper GI series performed failed to show any reflux. It showed tertiary contractions of the esophagitis (spasms) and some delayed emptying of the stomach, as well as some deformity of the antrum of the stomach. That deformity did not have any significance, especially in view of the fact that the endoscopy failed to show any ulcers in that area. Dr. Williams did not feel that the delayed emptying of the stomach was significant either, and he found no evidence of reflux. The Respondent then performed a vagotomy after taking down the previous fundoplasty in order to get to the vagus nerve to do the vagotomy, which is indicated for peptic ulcer disease. Thereafter, he had to redo the fundoplasty, which had previously been done in 1980. Dr. Williams felt that the lady's problem was probably dysfunctional and probably related to her first surgery. After the first fundoplication, she exhibited the same complaints she had before. She had been treated previously with Tagamet and, if she did have peptic ulcer disease, the endoscopy did not reveal it to be significant. Thus she did not need this further surgery which also left her with the same complaint she had before. A month after this surgery some dysphagia or difficulty in swallowing as well as esophageal dilation was experienced. These are symptoms of the so-called "gas bloat syndrome." This is involved with fullness and pain after eating and is a complication of a fundoplication. Dr. Williams found that she did not have significant esophagitis, and the problem was more likely "gas bloat" or some undiagnosed, dysfunctional gastrointestinal disease. She did not have an active ulcer and had no significant reflux. Additionally, the "3 plus" positive standard reflux test is not in and of itself sufficient evidence to justify a fundoplication. This test can be positive and still not represent any symptomatic condition. Dr. Williams thus opined that the performance of the fundoplication being taken down, a vagotomy performed and the fundoplication being redone (which was necessary once it was "taken down") was below the acceptable standards of a reasonable physician under similar circumstances and conditions in light of the symptoms exhibited. In a like vein, Dr. Roberts found that the patient did not appear to have esophageal strictures before she had the surgery. The hospital nursing notes suggest that constipation may have been a problem because of the laxatives given during the days preceding surgery. No ulcer was found demonstrated by Dr. Roberts, only inflammation of the pyloris as a result of the endoscopy. Dr. Roberts likewise felt no fundoplicatio was justified by the patient records in this case. Dr. Woodward, Respondent's expert, likewise indicated that the history reflected in the hospital chart was characteristic of the "gas bloat syndrome." He strongly suspected that the first anti-refluxoperation (fundoplasty) was satisfactory and that she did not need any further surgery. Like Drs. Williams and Roberts, he did not think that Mrs. Smith had an ulcer either. He felt the ulcer surgery and the concomitant taking down and replacing of the previously done fundoplasty was not necessary, but did not feel he had sufficient information to opine concerning whether malpractice existed. Dr. Skinner believed the operation to be appropriate under the circumstances. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Linda Turner is a 32-year-old female with a long history of medical complaints. Seven years prior to the subject admission, she had had an ovarian carcinoma which led to a hysterectomy, bilateral salplngo-oophorectomy and appendectomy. She had multiple abdominal complaints after that and was said to have ulcerative cholitis, which causes cramping and mucous in the stool. In November 1981, she was admitted with abdominal pain and was labeled as having a recurrent ulcer and right hip pain. She was admitted by Dr. Kahn from the emergency room. Her two primary complaints were sharp pain in the right hip and numbness in the leg and increased pain on hip movement, which had nothing to do with abdominal pain. She had three weeks of cramping and abdominal pain, which gradually increased with nausea and anorexia, epigastric burning with indigestion, associated with ingestion of food and liquids. She exhibited dark brown vomit on occasion, with lower abdominal tenderness. Her hemoglobin, chest X-ray, upper GI series and small bowel X-ray series was normal, as were pictures of the stomach. The barium enema she received was normal, as were her gall bladder tests, and CAT scan and PH reflux test. Dr. Elkadi was consulted, and he said that she had upper abdominal pain, nausea and vomiting for two years, which had worsened in the last three weeks. He stated that she had occasional regurgitation and dysphagia at the base of the neck. She was said to have had one tarry black stool before her admission, but Dr. Williams doubted there was any bleeding because her hemoglobin test was normal, and no positive stool was documented for blood. The doctor's notes indicated left lower quadrant pain and some stomach cramps. The pain increased with ingestion of food. She had an endoscopy on the 9th, which resulted in a normal biopsy. On one of the biopsy specimens, there was a small amount of blood under the mucosa, but this might be explained, according to Dr. Williams, by vomiting or trauma caused by the instrumentation itself during the endoscopy procedure. He saw no other evidence to indicate she had any bleeding from the esophagus. The patient had surgery on the 19th, and the operative record indicates that extensive adhesions were found in the lower abdomen. She also had a Nissen fundoplasty and a highly selective vagotomy. The vagotomy and the fundoplasty were unnecessary. The patient's primary problem was likely the abdominal adhesions which could explain the pain and cramps in the area of the lower intestine. The patient did have some symptoms that were suggestive of esophagitis in that, when she vomited, she had epigastric distress, but Dr. Williams could see no evidence of ulcer disease in her records and chart. Dr. Williams also was of the opinion that, although the lady had a record of having three tarry black stools, the fact that her hemoglobin had not changed and that no bleeding had been demonstrated after she was in the hospital, nor was any ulcer found, that the dark stools were evidently due to some other reason than bleeding. Although the endoscopy and related biopsy showed intramucosal bleeding, that was of a very slight nature and was likely due to the trauma of the instrumentation or the trauma of vomiting. There was no ulceration and no acute inflammation of the esophageal area. There was no evidence of significant hemorrhage originating in that area. Dr. Williams then opined that the patient's written records only justified an abdominal exploration. He felt that Dr. Elkadi should have stopped with the lysis of abdominal adhesions as a means of alleviating the patient's abdominal pain and cramps related to the small intestine, rather than proceeding with the fundoplasty and vagotomy in the gastroesophageal area, where there was no concrete evidence of esophagitis, ulceration or other disease. In short, the treatment given the patient was unnecessary and fell below the acceptable standards of similar physicians under similar circumstances. He exposed the patient to additional morbidity and a slight additional risk of mortality. Dr. Roberts essentially agreed with Dr. Williams' findings and stated that, other than Dr. Elkadi's own description about the endoscopy on these written records, no evidence or history suggestive of esophagitis was shown in this patient. He stated that, although the patient complained of chronic abdominal pain for three weeks, with nausea and loss of appetite, as well as epigastric "burning," he felt these were not sufficient enough to suggest chronic esophageal reflux disease indicative of a fundoplication. He opined that, on the basis of the tests done in this case, that a diagnosis of specifically what was causing the cramps, abdominal pain, nausea and loss of appetite and upper gastric burning could not be done and certainly not sufficient to support a decision to perform the surgery that was performed. The record was simply bare of any concrete evidence to suggest esophagitis being present, and he, too, felt that the treatment of this patient by the unnecessary surgery performed, fell below standards generally required of physicians under similar circumstances. Dr. Woodward, the Respondent's expert, was of the opinion that the patient's hospital chart did not support the operation and that the patient's history was not suggestive of the presence of esophagitis. He also found that the endoscopy, while being said to show esophagitis, also resulted in a normal biopsy, thus hemorrhage present was likely induced by the biopsy forceps, since you do not typically see hemorrhage caused by esophagitis, rather you see inflammation. Dr. Woodward did not think the patient had ever had esophagitis and did not think she needed the reflux preventative operation. Thus, he felt the procedures performed were unnecessary, although he would not actually state he had sufficient information to call this type and level of treatment malpractice. Once again, Dr. Skinner believed the treatment and operation to be appropriate. The opinion of Dr. Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Felix Williams was a 62-year-old black male who was admitted in August 1981 to the service of Dr. Kahn. At that time he had a three-week history of epigastric pain with radiation to the back. Mr. Williams had a long medical history of multiple hospital admissions and surgeries. He had previously had a vagotomy and a pyloroplasty, supposedly for duodenal ulcers, which may have been unnecessary. He also had a "Bilroth II" subtotal gasrectomy, or partial removal of the stomach and reattachment of the lower intestine, designed to better drain bile from the stomach. The patient had been taking Tagamet for two to three years before the August 1981 admission. The past surgeries did not relieve the patient's symptoms. He also had had a long history of pancreatitis, with recurring abdominal pain. He had been operated on many times with no relief and continued to have the chronic pancreatitis, related to a long history of alcoholism. After being admitted on August 1, 1981, with a history of abdominal pain, the patient's serum amylase tested as being elevated. Urine amylase was also elevated. The amylase readings were only a little above normal, however, and it is common in people who have had chronic pancreatitis for years to have only a minimal elevation of their amylase when having an acute flare-up of pancreatitis. This is because the pancreas, over the years, has pretty much destroyed itself, according to Dr. Williams. The patient's upper GI series X-rays showed hiatal hernia with some reflux, but no stricture demonstrated. Ultrasound tests of the gall bladder and pancreas showed them as being essentially normal. CAT scans of the abdomen on August 27, compared to previous CAT scans, showed less enlargement of the pancreas, although it was still enlarged, which was consistent with pancreatitis. On August 31, an endoscopy was performed by Dr. Elkadi which showed a hiatal hernia and some esophagitis, as well as some alkaline gastritis and alkaline esophagitis. The biopsy done by the pathologist showed benign gastric mucosa, and the patient had no strictures of the esophagus. Bile studies showed no calcium bilirubinate crystals. In September 1981, during this same admission, Dr. Elkadi performed a cholecystectomy, or removal of the gall bladder, because of chronic cholecystis. He also performed a Roux-en-y revision of the original surgery. That is, he converted the Bilroth II surgical procedure to a Roux-en-y and also did a fundoplasty. Dr. Williams did not feel the patient needed surgery at all, but rather his symptoms were due to chronic pancreatitis. He felt that if the person was going to be operated on, however, that the removal of the gall bladder was certainly indicated, and that this is one of the causes of pancreatitis. In this case, the man had a long history of alcoholism, which serves to cause pancreatitis which, once it gets started, tends to be self- perpetuating. Dr. Williams felt that any surgery done at this point with the patient would result in the same problem, that is not alleviating the pancreatitis and associated abdominal pain. Dr. Elkadi knew of the pancreatitis or should be presumed to have known because the CAT scan taken on August 27, 1981, as well as the amyfase test results, revealed pancreatitis. He did not strongly consider pancreatitis as the primary problem, however, and, according to his notes, thought that repairing the reflux condition he believed to exist would take care of the problem. The Roux-en-y surgical procedure, as well as the fundoplasty, however, would not address the primary problem of pancreatitis, so the abdominal pain would still continue, which in fact it proved to do after Mr. Williams recovered from surgery. The pancreatitis-induced vomiting will not occur as much after the fundoplasty because that procedure prevents vomiting, but the patient will still have the same morbidity; it will just be manifested in a different way. The opinion of Dr. Williams establishes that the gastroesophageal reflux, which was seen on the endoscopy, in reality was due to the pancreatitis, and that the fundoplasty which was performed would do nothing to alleviate the pancreatitis. It might make it be manifested somewhat differently by reducing vomiting, but the abdominal pain and elevated amylase characteristic of the pancreatitis were still there. In summary, Dr. Williams felt that the removal of the gall bladder was justified and that the Roux-en-y procedure, which is designed to move bile juices from the stomach, would be justified, but for the fact that the primary problem was pancreatitis, which surgery of that type will not correct. Dr. Williams did not feel that the Respondent misdiagnosed pancreatitis, but just that he was "overly optimistic" and should have appreciated the fact that surgical treatment of this type would not have helped the man and that the only surgical treatment for chronic pancreatitis is removal of the pancreas, which causes a severe morbidity problem in and of itself and would probably not be indicated either. Thus, Dr. Williams opined that Dr. Elkadi's treatment of Felix Williams fell below accepted standards of physicians practicing under similar circumstances and conditions. Dr. Roberts also felt that the patient's basic problem was pancreatitis, relying on the same records that Dr. Williams relied on in his testimony. The patient had epigastric pain radiating through to the back, which is a classic indication of pancreatitis, which, when coupled with elevated serum amylase, establishes the presence of acute pancreatitis. Dr. Roberts was unable to find any history of nausea or vomiting, which would suggest gastric esophageal reflux, the admitting diagnosis being simply abdominal pain and pancreatitis. Since the patient had pancreatitis, that condition is consistent with the slowness of the stomach to empty itself, which in itself could have permitted reflux with changes consistent in the esophagus with esophagitis. Dr. Roberts was of the opinion that the records did not show the necessary symptomology to justify the anti-reflux surgery which was done. He thus felt that the standards of care of a reasonable, prudent physician under similar conditions and circumstances had not been met by the Respondent. The Respondent's expert, Dr. Woodward, after reviewing the records of Felix Williams, also felt that the symptoms did not suggest reflux esophagitis, the indication for the fundoplication surgery. Dr. Woodward did not, in his testimony, discuss the fundoplication procedure specifically. Dr. Woodward opined that the symptoms did not suggest reflux esophagitis, although this was diagnosed by the endoscopy, which was performed by the Respondent himself. He also did not feel the biopsy report was very convincing and felt that "the pathologist was trying to help out the surgeon." Nevertheless, Dr. Woodward felt that there was no doubt about his having reflux alkaline gastritis, which Dr. Williams noted as well, and felt that this was due to the unnecessary surgeries already performed by past surgeons. Dr. Woodward noted that this was also associated with marked gastric retention or failure of the stomach to empty rapidly enough. He thus felt that the patient should have another operation, if nothing else, to try to get the stomach to empty better and to divert some of the duodenal fluid away and hopefully give him some degree of pain relief. This surgery was done in the form of the Roux-en-y procedure performed by the Respondent. Neither Dr. Williams nor Dr. Woodward felt that this surgery was improperly performed. Dr. Williams merely felt that it was probably unnecessary, since the root problem was pancreatitis. However, Dr. Woodward established that, at least in an effort to aid stomach emptying and avoid gastric pain associated with bile retention in the stomach, that the Roux-en-y procedure probably was necessary. None of the three doctors opined that the fundoplication was necessary, however, since reflux esophagitis was not present. In summary, it is found that the surgeries performed, consisting of the cholecystectomy and the Roux-en-y procedure were appropriately done under the circumstances, although this is a marginal case for such surgeries being indicated, based upon the totality of the expert testimony, because of the underlying problem of pancreatitis. In any event, however, the fundoplication which was done was shown to be unnecessary and not medically indicated. Thus, as to that procedure, the Respondent's practice with regard to this patient fell below the medical practice standards referenced above.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners suspending the Respondent's license for a period of one year, with reinstatement to active status contingent on Respondent making satisfactory showing, by completing continuing education courses, or in such manner as the Board may elect, that he has worked diligently to enhance his knowledge and skill in the area of gastroenterological surgery, including the "indications" for such. It is further recommended that the Respondent's license be placed in probationary status for two years thereafter, with such terms and conditions as the Board deems appropriate, within the guidelines of Rule 2lM-20.001(t), Florida Administrative Code. The failure to comply with any such terms and conditions should result in revocation. DONE and ORDERED this 27th day of December, 1988, In Tallahassee, Florida. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 FILED with the Clerk of the Division of Administrative Hearings this 28th day of December 1988. APPENDIX TO RECOMMENDED ORDER CASE NOS. 86-1140 & 86-1327 Petitioner's Proposed Findings of Fact: 1. Accepted. 2-3. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 6-17. Accepted. 18-20. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23-25. Accepted. 26. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 27-29. Accepted. 30. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #1. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #2. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 36 #1. Accepted. 36 #2. Accepted. 37-40. Accepted. 41. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 42-44. Accepted. 45. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Respondent's Proposed Findings of Fact: 13-20. Accepted, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 21-22. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23. Rejected as not being of probative material import. 24-25. Rejected as to its purported material import. 26-29. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as to its purported material import. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 33-34. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 37-39. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 42-43. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not as to its purported material import. 46-47. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 48. Accepted. 49-53. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 54-56. Rejected as to its purported material import. 57. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 58-61. Accented. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 64-65. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. Rejected as not being of probative material import. 68-69. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 74-77. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 83-84. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 85-86. Accepted. 87-89. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 90-91. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not in itself dispositive of any material Issue. 94-95. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 98-99. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 100. Rejected as to its purported material import. 101-102. Rejected as subordinate to the - Hearing Officer's Findings of Fact on this subject matter. 103-104. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 105-107. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not in accordance with clear and convincing evidence. Rejected as not being of probative material Import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not to the extent that the fundoplication was indicated. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter, as not being of probative material import and as constituting argument of counsel. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence, was subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not being of probative material import. 117-119. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 120. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not of material import in itself. 121-122. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not in itself dispositive of material issues. 123-127. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 128-130. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 131-132. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 133-142. Really amount to legal argument and recitation of testimony and evidence regarding the Motion to Dismiss, which has been dealt with supra. COPIES FURNISHED: Roosevelt Randolph, Esquire KNOWLES & RANDOLPH 528 East Park Avenue Tallahassee, Florida 32301 Spiro T. Kypreos, Esquire LEVIN, MIDDLEBROOKS, MABIE, THOMAS, MAYES & MITCHELL, P.A. 226 South Palafox Place Post OffIce Box 12308 Pensacola, Florida 32581 Harry Rein, Esquire 3803 Lake Sarah Drive Orlando, Florida 32804 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, in that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, by failing to treat the patient's preoperative coagulopathy and/or failing to use an alternate vein that would have allowed visualization of the shunt placement into the vein thereby reducing the risk of causing a hemorrhage given the patient's preoperative history, and, if so, what penalty should be imposed. AS TO CASE NO. 01-4407PL Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to distally clamp part of the arteries prior to manipulation of the aneurysm and by failing to ensure periodic monitoring of the patient's condition postoperatively for evidence of ischemia or other problems and, if so, what penalty should be imposed.
Findings Of Fact Based on the evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: FACTS COMMON TO BOTH CASES Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapters 456 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0036360. Respondent is board-certified in thoracic and general surgery. FACTS RELATED TO CASE NO. 01-4406PL Patient D.J.P. was a 54-year-old female with a history of liver resection for carcinoma. Patient D.J.P. had contracted Hepatitis C in the 1960s from a blood transfusion, after being the victim of a gun shot wound during a robbery at a convenience store. Patient D.J.P. subsequently had developed cirrhosis secondary to the Hepatitis C. Cirrhosis is a scarring process of the liver that results in the displacement of the normally functioning liver tissue. A healthy liver processes lymphatic fluid back into the bloodstream. However, a cirrhotic liver cannot properly process the lymphatic fluid back into the bloodstream. Therefore, lymphatic fluid backs up within the liver and weeps out the covering over the liver and into the abdominal cavity. Patient D.J.P. presented to Respondent on February 1, 1994, after being referred to Respondent by Michael Carey, M.D., the primary care physician, for evaluation for implanting a peritoneal venous shunt. A venous shunt is a conduit designed to take ascitic fluid from the abdomen and put it back in the vascular system. The shunt removes the fluid from the abdominal cavity and transports it to the vascular system where it can be absorbed. The procedure is for the patient's comfort and does not prolong the patient's life. The procedure is for patients with end stage liver disease. After obtaining a medical history and conducting a physical examination, Respondent's assessment of the Patient D.J.P. was massive ascites secondary to cirrhosis and previous liver resection. Respondent believed that Patient D.J.P. was a candidate for a venous shunt procedure due to the fact that she was very symptomatic from her massive ascites and she was on the maximum medical therapy. The mortality rate for this type of procedure is between 5 and 25 percent or at the very least, one-in-twenty patients would die from this procedure. Complications associated with this type of procedure include disseminated intravascular coagulopathy (hereinafter referred to as "DIC") which may lead to the general worsening of the disease or death. The patient was informed of this mortality rate as well as of the complications associated with this procedure. Patient D.J.P. decided to think about the procedure and contact Respondent's office when she wanted the shunt inserted. On February 10, 1994, Patient D.J.P. called Respondent's office and asked to have the shunt inserted as soon as possible. Respondent scheduled the procedure for February 14, 1994, and signed the written surgical consent form. Prior to the surgery, lab tests were performed on Patient D.J.P. The lab report indicated that the patient's prothrombin time was 14.3, with a normal range being 10.7-12.8. Prothrombin time ("PT") is a measurement of one aspect of the blood clotting mechanism. This was considered slightly abnormal and not an indication of a clotting problem or coagulopathy. Respondent decided it was not necessary to address Patient D.J.P.'s abnormal PT prior to the procedure by preoperatively administering Vitamin K or fresh frozen plasma. On February 14, 1994, Patient D.J.P. was transported to the operating room at approximately 12:10 p.m. After Patient D.J.P. was placed under general anesthesia, Respondent began the venous shunt operation at approximately 12:34 p.m. Respondent attempted to access the right jugular vein to insert the shunt. He found this vein to be unusable because it was too scarred from previous surgeries. Respondent then proceeded to access the right subclavian area to insert the shunt. Once the shunt was inserted into the subclavian area, Respondent positioned it in the superior vena cava. The shunt was noted to be in position in the superior vena cava. Respondent then removed eight liters of ascitic fluid from the abdominal cavity. After removing the ascitic fluid, he then put one liter of saline into the abdominal cavity to dilute any remaining ascitic fluid which allowed any remaining fluid to be more easily absorbed into the vascular system. The Patient's central venous pressure dropped from 8 to 2. Hespan and Albumin were then administered to replace any lost volume and it helped to increase the colloidomotic pressure. At this point, Patient D.J.P.'s central venous pressure (CVP) increased from 2 to 14 or 15. This is a faster than normal rate. Upon finding that the shunt was operating well, Respondent closed the abdominal portion and the patient was extubated. Petitioner claimed that fluoroscopy was not used to ensure that the shunt was positioned in the proper place. A Fluoroscope is like a real-time X-ray. A fluoroscope has two parts to it: a C-arm, which goes above the patient and underneath the bed, and two screens where the doctor can see what is going on. The C-arm is approximately 5-and-a-half feet tall. It is below the standard of care to do a venous shunt procedure without using a fluoroscope. It would enable Respondent to visualize the placement of the shunt. Felicia Whitmer, a scrub technician, and Rene Myers, a circulating nurse, prepared the operating room for Patient D.J.P.'s procedure on February 14, 1994. Both Felicia Whitmer and Rene Myers testified that there was no fluoroscope in the operating room on February 14, 1994. Respondent testified that there was a fluoroscope in the operating room on February 14, 1994, during Patient D.J.P.'s procedure and that he used it to assist him. The evidence is not clear and convincing that the fluoroscope was not used during the course of the operation. It is considered within the accepted standard of care to access the right subclavian vein to insert a shunt of this type because this vein follows a gentle curve or path. With this gentle curve in the vein, there is less risk of damage, i.e. puncture, to the vein. In contrast, the left jugular vein follows a more sharp-angled 70-degree bend-curve in the vein where one risks the danger of the shunt coming out of the bottom of the vein or perforation and, thereby, damaging the vein. Respondent ordered an X-ray to confirm placement of the shunt and catheter. The X-ray revealed that the shunt had good positioning but the right lung was filled with fluid. The patient was re-intubated and Respondent inserted a chest tube into the patient which would expand the patient's lung, oxygenate the patient and allow for fluid removal. Three or four liters of fluid were removed. The fluid was originally serous and pink tinged and shortly thereafter, turned bloody. Respondent noted that there was bruising around the wounds. Additionally, the patient's breathing became shallow and her blood pressure began to deteriorate. Resuscitative efforts were performed and Respondent re- entered the shunt area to clamp the shunt to prevent any ascites from flowing into the venous system and to prevent further coagulation and massive bleeding. Despite heroic resuscitative efforts, the patient's condition continued to deteriorate and the patient died. The cause of death was determined to be DIC and severe coagulopathy from drainage of the ascitic fluid into the venous system. Respondent made the determination that the patient did not have preoperative coagulopathy. Respondent testified that if the patient did have preoperative coagulopathy, he would not have performed the procedure because the patient would not be able to make the clotting factors well enough for problems that would occur after the shunt was inserted. It was Respondent's opinion that the patient did not have a serious clotting problem. Based on her lab report, Patient D.J.P. had a slightly abnormal PT and this was not an indication of a clotting problem. Respondent reviewed the lab reports and determined the PT (the measurement of one aspect of blood clotting mechanism), to be only slightly elevated. It measured 14.3 with a normal range being 10.7-12.8. Moreover, the PT International Normalized Ratio (INR) (which is the standardized measurement of PT) was 1.63 where the therapeutic range was 2-3. Therefore, this was slightly below average. Dr. Yahr testified that an abnormal clotting problem is a clinically evident problem and not an incident of a lab number. If Patient D.J.P. had a clotting abnormality, adverse conditions or symptoms would have been evident with the incisions that were made prior to the shunt being opened. Rather, normal clotting reactions occurred. Coagulation occurred right after the shunt was opened and the ascitic fluid began to flow into the atrium. Dr. Yahr testified that the etiology of the coagulation was the body's reaction to the ascitic fluid after the shunt was opened. Accordingly, it was Dr. Yahr's opinion that Respondent did not fail to treat the preoperative coagulopathy because upon his examination of the patient, he determined that no such preoperative coagulopathy existed prior to the procedure. Dr. Yahr testified that the patient did not have abnormal bleeding. Her liver failure was the result of scarring and abnormal liver function. Therefore, administration of clotting factors such as Vitamin K and fresh frozen plasma was not indicated or medically necessary. Petitioner presented the expert testimony of John W. Kilkenny, III, M.D. Dr. Kilkenny is board-certified in general surgery and has been for 11 years and is currently a professor with the University of Florida College of Medicine, Department of Surgery in Jacksonville, Florida, a position which he has held for the last six years. According to Dr. Kilkenny, Patient D.J.P.'s elevated PT was a cause for concern in that it was an indication that the patient's ability to clot or coagulate was diminished. It is not clear and convincing that the standard of care required that the elevated PT be treated by infusing fresh frozen plasma or Vitamin K. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by failing to use an alternate vein that would allow visualization of the placement of the shunt. Respondent first attempted to access the right jugular vein to insert the shunt but found it be unusable because it was too scarred. Respondent, acting as a reasonably prudent physician and using sound medical judgment, accessed the right subclavian area to insert the shunt. After the shunt was inserted into he subclavian vein, Respondent claimed he was able to visualize the placement of the shunt by the use of fluoroscopy. Furthermore, the operative notes seemed to indicated that the procedure was performed under fluoroscopic control and the shunt was found to be in position. Therefore, Respondent accessed an appropriate alterative vein-the subclavian vein, which allowed visualization, with the assistance of fluoroscopy, of the placement of the shunt. As to the second issue, Dr. Kilkenny opined that the standard of care requires direct visualization for insertion of the shunt. By not accessing a vein under direct visualization, such as with Respondent's subclavian approach, the surgeon is, in essence, hunting for the vein, and risking damage to the wall of the vein that may not be evident immediately. The rapid rise in CVP from 2 to 14 or 15 was also a concern for Dr. Kilkenny because it was not normal, and did not mean that the shunt was placed correctly of that the shunt was functioning properly. Dr. Kilkenny noted that it was unlikely that the bleeding in the chest cavity was caused by damage to an intercostals vessel when the chest tube was inserted because the chest X-ray that was taken prior to insertion of the chest tube showed a complete opacification of the right side and a shifting of the major vessels within the middle of the chest over to the left side. According to Dr. Kilkenny, the chest X-ray indicated that there had already been some sort of bleeding in the right chest prior to the insertion of the chest tube. Dr. Kilkenny disputed Respondent's theory that Patient D.J.P. died as a result of DIC. Dr. Kilkenny asserted that Respondent fell below the standard lf care in that, given Patient D.J.P.'s rapid decompensation, he failed to consider whether the patient's subclavian vein had been damaged, a condition which could have been addressed surgically. Dr. Yahr opined that Patient D.J.P. died of DIC that occurred within a short period of time after Respondent opened up the shunt and ascitic fluid was introduced into the atrium of the heart. Although Dr. Yahr further admitted that the bleeding in the chest could have occurred as a result of damage to the subclavian vein, and that it was below the standard of care to access the subclavian vein without using fluoroscopy, the evidence is not clear and convincing that either event occurred. It is found that Petitioner has failed to establish by clear and convincing evidence that the standard of care required Respondent to use an access site that allowed direct visualization of the placement of the shunt into the vein, or that Respondent failed to use fluoroscopy in order to directly visualize insertion of the shunt into the subclavian vein. AS TO CASE NO. 01-4407PL On August 22, 1997, Patient H.H., a 55-year-old female, was diagnosed with an abdominal aortic aneurysm measuring approximately 4.5 cm transverse diameter and beginning approximately 1-2 cm below an enlargement or swelling, of a blood vessel resulting in a weakening or thinning out of the vessel wall. On November 28, 1997, Patient H.H.'s aneurysm had grown to 5 cm within a three-month period and was occluded with partial thrombosis with a true lumen around 2.7 cm and extended down to the bifurcation of the abdominal iliac. This put the patient at risk for rupture of the aneurysm. Thrombosis is a blood clot within a vessel or within the vascular system. It does not embolize (travel) from another part of the body. It starts in a particular vessel and causes its damage from there. It is an acute clot that occurs in the vessel secondary to stasis (non-moving ) or some kind of coagulation or clotting deficiency or abnormality. Thrombotic activity most often begins by occluding the smaller vessels in the vascular system, such as those smaller veins located in the feet. On December 2, 1997, Patient H.H. first met with Respondent, who performed a complete medical history and physical examination and confirmed the presence of a 5 cm abdominal aneurysm. Patient H.H. was a 55-year-old female who smoked 1- and-a-half packs of cigarettes per day, had a blood pressure of 182/104 despite the fact that she was taking 50 mg Atenolol for hypertension (high blood pressure), and had a 30 percent blockage of the coronary artery. Previously, she had a cardiac catheterization, followed by an angioplasty of the femoral vessel in her left leg. Patient H.H. advised Respondent that her legs gave out on her after she walked two blocks, but that she did not have associated chest pain. Respondent confirmed earlier diagnosis of Patient H.H.'s medical condition as single vessel coronary artery disease, abdominal aortic aneurysm, hypertension, and claudication with femoral occlusive disease. Respondent also found diminished femoral pulses and palpable Dorsal pedal pulses present in both feet. Patient H.H.'s medical records indicated that this smoker of 30 years suffered from diabetes, peripheral vascular disease, intermittent clottication of the leg, hypertension, atherosclerotic disease, hypercoagulopathy, anthithrombin III deficiency, high cholesterol, and diminished protein and pH levels. Respondent prescribed prescription medication, Procardia to lower Patient H.H.'s blood pressure and Zyban to help her stop smoking. He recommended that the patient return in a week for follow-up. On December 15, 1997, Respondent continued to prepare Patient H.H for surgery. He again advised her to stop smoking and to purchase and take medication to help her stop smoking. Patient H.H.'s blood pressure was lower, 144/84, and although she had not purchased or taken the medication, she reduced her smoking down to one-half pack of cigarettes per day. Respondent then advised Patient H.H. to make plans to undergo the abdominal aortic aneurysm ("AAA") repair. Patient H.H. informed Respondent that she wanted to wait a little longer while she made financial arrangements to pay for the surgery. Respondent advised Patient H.H. to completely quit smoking before the surgery and advised her to return in one month for additional preoperative evaluation. On January 12, 1998, Respondent continued to prepare Patient H.H. for surgery by ordering a cardiac clearance (thallium evaluation) of the patient's heart to ensure she could tolerate the surgery before attempting the AAA repair. On February 3, 1998, Patient H.H. presented for the thallium evaluation of the heart and, on February 9, 1998, obtained cardiac clearance for repair of the AAA. On February 11, 1998, Respondent continued to prepare Patient H.H. for AAA surgery and suggested she donate two units of blood which would be used during the surgical procedure. Respondent scheduled AAA repair surgery for March 6, 1998. Respondent advised Patient H.H. of the risks associated with AAA surgery and specifically mentioned the risk of a heart attack, bleeding, kidney damage and loss of legs. He also advised that the risks associated with intra-operative AAA repair include spontaneous rupture, embolization of material from the wall distally, myocardial infarction, bleeding, injury to viscera of the small vessels, devascularization of the colon causing ischemic colitis, death, kidney blockage. Patient H.H. indicated she understood the risks and despite the risks associated with this type of surgical procedure, including the risk of death, she agreed to the procedure. Preoperative testing by angiogram was not required for Patient H.H. The aneurysm was a massive aneurysm presenting a very serious health risk of imminent rupture. The size of Patient H.H.'s aneurysm (5 cm) made AAA repair an emergency in a sense because there was almost a 100 percent chance of rupture with in the next six months. Any findings determined by angiogram would not have changed the outcome of the case because Respondent had to definitively treat the aneurysm first. Additionally, an angiogram is a very expensive test and Patient H.H. expressed a concern about her financial situation with respect to the AAA repair. It is reasonable to not do studies that a physician does not feel are absolutely necessary. The patient's financial concerns are part of the pathology. On March 6, 1998, Patient H.H. was admitted to Winter Haven Hospital and filled out and signed the Special Authorization for Medical and/or Surgical Treatment form indicating her consent to the surgical procedure which Respondent was to perform. She indicated that she understood the risks associated with such surgical procedure. Paragraph two of the informed consent form states in pertinent part: I hereby certify that I have given complete and informed consent for the above named operation and/or procedures, and Dr. L. Thomas has explained to me the reason why the above-named operation and/or procedure are considered appropriate, its advantages and possible complication, if any, as well as possible alternative modes of treatment. I also certify that no guarantee or assurance has been made as to the results that may be obtained. The operative procedure on the consent form was signed by Patient H.H. at 6:10 a.m. on March 6, 1998. Surgery indicated on the consent form was for a resection abdominal aortic aneurysm (AAA repair). After Patient H.H. was taken to the operating room and administration of anesthesia began, Respondent performed his routine preoperative check of femoral and pedal pulses. Checking for femoral and pedal pulses is the type of preoperative work-up Respondent routinely performs while he waits for the anesthesia to take its effect on the patient. The operative report indicates that the abdominal aneurysm was "very large" extending quite high within 1-2 cm from the renal vein and down to and involving the common and hypogastric arteries and noted to be "quite saccular" with "impending rupture in the near future at the neck." The common iliacs were noted to be "quite large and aneurysmatic." The external iliacs were soft but extremely small, "approximately 4-5 mm in size, certainly less than half, more like 1/4 the size of a normal iliac" but nevertheless usable vessels to make his anastomosis. As Respondent was bluntly dissecting (separating the tissues using the fingers) the aortic aneurysm from the venous plexus to position his proximal clamp when one of the lumbar veins was encountered and mass bleeding occurred. The venous plexus is a grouping of veins located under the aorta that can best be described as a wagon wheel. The system has a hub and all the veins in the grouping extend outward from the hub. If one of the veins in the grouping is injured, it will bleed heavily, but the bleeding is controllable. The lumbar veins are part of the venous plexus and a tear of the lumbar vein is a known risk during this type of surgery. Patient H.H. suffered the loss of three times the amount of blood as would have been routinely expected. The sudden blood loss caused the patient's condition to rapidly deteriorate. Dr. Wickstrom-Hill, Anesthesiologist, testified that had Respondent not controlled the blood loss, and had not maintained Patient H.H.'s vital signs, she would have died. Using sound medical judgment, Respondent elected to bypass the aneurysmatic common iliacs and make his anastomosis of the graft to the external iliacs in order to not disconnect or separate the aortic or common iliac aneurysms from the iliac vein. This is a very fragile vessel and could have resulted in further massive bleeding and possible death of the patient. A reasonable prudent physician faced with a similar circumstance and situation would not attempt to mobilize the aneurysm further if doing so would cause additional massive blood loss and possible death of the patient. The hypogastric arteries (a/k/a the internal iliacs) serve to provide the pelvic viscera (bladder, rectum, etc.) with blood. During the AAA repair, Respondent performed an embolectomy on both legs following manipulation of the aneurysm. The purpose of this procedure was to remove any debris which may have dislodged from the aneurysm and flowed distally to the legs. The procedure involves running a Fogarty catheter down the femoral arteries as far as the catheter will go, then inflating a balloon located at the end of the catheter. Once the balloon is inflated, the surgeon will extract the catheter, pulling the debris out of the artery. This process is repeated as necessary to remove all debris. Fresh clot was obtained from both legs, indicating a lack of debris. Prior to completing the anastomosis of the bifurcated graft to the aorta and external iliacs respectively, Respondent ran a Fogarty catheter down proximal (back into the graft itself), to remove any debris in the graft itself. Finally, he back-bled the graft (allowed blood to flow out of the graft, to, again, ensure that there existed no debris in the graft). On March 7, 1998, Patient H.H.'s medical condition stabilized such that Respondent felt it safe to return Patient H.H. to the operating room to undergo an additional embolectomy of the legs and an endarterectomy of the right femoral artery. The record demonstrates that Respondent believed he collected embolic debris from the femoral arteries. However, based upon the pathology report and the testimony of Dr. Zeller, the debris removed from Patient H.H. during this procedure was acute blood clots and atherosclerotic plaque. This finding is consistent with thrombotic material and not a result of debris coming from another location as it tends to demonstrate that Patient H.H. had a clotting disorder consistent with her medical history. The record also demonstrates that upon completion of the procedure, Patient H.H. was noted to have excellent pulses in the superficial and profunda femoral arteries distal to the anastomosis with good emptying and filing of the vessels. Before, during, and after the AAA repair, Respondent used Heparin (an anti-clotting drug) in an effort to prevent the formation of clots throughout Patient H.H.'s vascular system. Intraoperatively, on March 3, 1998, Respondent administered 10,000 units of Heparin. Normally a patient will respond to 5,000 units. Despite giving Patient H.H. twice the normal amount of Heparin, Patient H.H. continued to have a lowered clotting time. It is noted in the medical record that Patient H.H. had an Antithrombin III deficiency. Antithrombin III is one of the factors that control how blood in the human body clots. Patient H.H.'s Antithrombin III deficiency is a hereditary defect that contributed significantly to her continued clotting despite the use of pharmacological intervention (substantial amount of Heparin). Respondent testified that in his medical training and experience, Patient H.H.'s Antithrombin III deficiency level was near fatal. Because Patient H.H. was hypercoagulative, thus causing the small vessels to clot off, on March 13, 1998, Patient H.H. underwent bilateral above the knee amputations. Hypercoagulopathy is a tendency to clot without anything being done - the blood just clots. This can be caused by a lower-than- normal blood pressure for a period of time and by having an Antithrombin III deficiency. Respondent observed during the surgery that this patient was hypercoagulative because he could see the blood clotting in the wound despite the fact that Patient H.H. was on twice the normal amount of Heparin. Respondent practiced within the standard of care at all times during the treatment of Patient H.H. Blood-flow going retrograde back into the common and iliac aneurismal sacs did not place Patient H.H. at a risk of rupture. The operative report clearly demonstrates that the aortic aneurysm involved the common iliacs and extended below the hypogastric arteries. The operative report also demonstrates that the external iliacs were extremely small, approximately one-quarter of the normal size. A reasonable and prudent surgeon, faced with a similarly situated patient with a massive sized aneurysm and the extremely small size of the distal external iliacs, would conclude that the pressure gradient now being carried to the graft rather than to the aneurysm would diminish flow to the aneurysms making the possibility of rupture unlikely. Moreover, the aneurysms were filled with calcified atherosclerotic plaque and other thrombotic (non-mobile) material. Dr. Begelman testified that calcified aneurysms do not tend to rupture as much. On direct examination, Dr. Begelman, Petitioner's expert, could not conclusively determine whether Respondent's surgical treatment of Patient H.H. fell below the standard of care and that distal clamping is an intra-operative decision to be made by the surgeon. Dr. Begelman who testified that he accepted Respondent's opinion that the iliacs were too large or too thin walled and could not distally clamp the aneurysm and that such decisions are those made by the surgeon on the case. Drs. Begelman and Seller and Respondent testified that it is usual and customary during this type of surgical procedure to distally clamp the aorta and that it is expected of a reasonable and prudent surgeon to make every attempt to do so. Nevertheless, all three doctors recognized that there are times when you cannot or should not distally clamp if to do so would cause further injury to the patient or death. Patient H.H. presented with very massive aneurysms of both the aorta and common iliacs making distal clamping impossible without sacrificing the hypogastric arteries thus placing Patient H.H. at risk for further injury or death. Petitioner's expert accepted Respondent's assessment of the condition of the iliacs and that Respondent did not want to dissect the iliacs off the iliac vein, which one needs to do in order to tie off distally. Dr. Begelman testified that he could not ascertain whether Respondent fell below the standard of care with respect to Respondent's treatment of Patient H.H. intraoperatively. Respondent acted within the standard of care and, therefore, did not violate Section 458.331(1)(t), Florida Statutes, when he did not clamp the distal arteries before manipulation of the aneurysm. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by sewing the bifurcated graft to the external iliacs and making no attempt to disconnect the aneurysm from the common and internal (a/k/a hypogastric) iliacs. The common and internal iliac tissues were also diseased because of their involvement with the aneurysms coupled with the fact that the aneurysm and surrounding tissue was inflamed. Inflammation causes the tissues of the surrounding viscera to become sticky and by that, stick together making separation difficult and more prone to bleeding on manipulation. Normally, the surgeon must bluntly dissect (lift up) the distal end of the aorta in order to place the distal clamps on the aorta below the aneurysm. However, the inflammation present in Patient H.H.'s aorta made it impossible to mobilize (lift up) the distal aorta for clamping because the tissue was stuck to the iliac vein which could have caused Patient H.H. to suffer a lethal blood loss. Normally, blood loss associated with this type of surgery amounts to 500 ccs for the total surgery. Patient H.H. lost 1500 ccs during the manipulation of the aortic aneurysm to place the proximal clamp and a total of 2400 ccs during the entire surgery which represented a blood loss of nearly 25-40 percent respectively of her estimated total blood volume. Respondent used sound medical judgment by making no attempt to dissect the common iliac from the subordinate tissue because, in his training and experience, the separation of tissues would have caused further, possible lethal bleeding. Drs. Begelman and Zeller, experts for Petitioner and Respondent respectively, testified that a reasonably prudent surgeon would not clamp below the common iliacs if to do so would sacrifice the hypogastric arteries and thereby cause irreparable harm or death to the patient. Dr. Zeller testified that the hypogastric arteries are of such importance that not clamping them, even at the risk of embolization, would nevertheless be within the standard of care. Respondent closely monitored Patient H.H. postoperatively. A reasonable and prudent surgeon is not expected to remain in the recovery room with his post-surgical patient until the patient becomes stable. Rather, the reasonable and prudent surgeon is expected to utilize the nursing staff who are charged with attending to the patient and to keep the physician updated on the patient's medical condition. Petitioner's witness, Doris Gutierrez, was the recovery room nurse on duty on March 6, 1998. Her duties included monitoring and reporting changes in Patient H.H.'s condition to Respondent. The record demonstrates that Respondent closely monitored Patient H.H. postoperatively by being in contact with the nursing staff and thereby giving orders for care and treatment to the nursing staff, either by telephone orders ("TO") or in person by verbal orders ("VO") to stabilize the patient. While in the recovery room, Patient H.H. was intubated, on a respirator. Petitioner's witnesses, Doris Gutierrez, confirmed Respondent's monitoring of Patient H.H. when she testified that she called Respondent several times to provide updates on Patient H.H.'s condition. The record demonstrates that postoperatively on March 6, 1998, Respondent wrote his initial order to the nursing staff at 12:30 p.m. while sitting in post-surgical recovery with Patient H.H. Thereafter, Respondent continued to monitor Patient H.H.'s condition and remained in communication with the nursing staff and wrote orders at 1:30 p.m., 2:30 p.m., 3:25 p.m., 5:00 p.m., 5:15 p.m., 8:15 p.m., and again on March 7, 1998 at 12:24 a.m. Following his TO on March 7, 1998, at 12:24 a.m., Respondent next saw Patient H.H. 7 1/2 hours later, at 8:00 a.m., prior to taking Patient H.H. to the surgery room to perform the endarterectomy and embolectomy. Ms. Gutierrez testified that she does not always note when the doctor comes back into the recovery room to give orders. She could not testify as to events that took place after Patient H.H. was transferred to the Surgical Intensive Care Unit ("SICU"). She also stated she did not know how many times Respondent went to SICU because she did not work in SICU when Patient H.H. was transferred out of the recovery room. Ms. Gutierrez was also unable to testify as to when the last time was that Respondent came to the recovery room. Respondent testified that there is a difference between a TO and a VO, the latter indicating that the physician was present in the room at the time he gave his order to the nurse. The evidence is not clear and convincing that Respondent did not provide appropriate postoperative monitoring of Patient H.H.
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 with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4406PL, and DOH Case No. 1994-12341. Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4407PL, and DOH Case No. 1999-57795. DONE AND ENTERED this 8th day of August, 2002, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of August, 2002. COPIES FURNISHED: William R. Huseman, Esquire Romualdo C. Marquinez, Esquire Huseman, Marquinez & Schlegal, P.A. 6320 St. Augustine Road, Building 12 Jacksonville, Florida 32217 Kim Kluck, Esquire Richard J. Shoop, Esquire Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations that Respondent violated the provisions of Subsections 458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient M.R., as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0077248. Respondent is a vascular surgeon, who is not board-certified in his area of practice. On November 27, 2000, Patient M.R., a 70-year-old male, was admitted to ORMC for a right-side carotid endarterectomy. Patient M.R. initially presented to Respondent in October 2000 with a number of health conditions, including chronic obstructive pulmonary disease (related to a 54-year history of smoking), cerebral vascular disease, atherosclerotic changes, and hypertension. Patient M.R. had a significant cardiac condition which resulted in a bypass procedure. It was determined at that time that Patient M.R. had significant stenosis in both carotid arteries which would require Patient M.R. to undergo two separate procedures, known as carotid endarterectomies. The left carotid artery was the subject of the first procedure in October 2000. Patient M.R. tolerated this procedure with no complications. Subsequent to the first carotid endarterectomy, but prior to the second, Patient M.R. suffered a transient ischemic attack (TIA), which is commonly referred to as a "mini-stroke." The symptomatic clinical presentation placed Patient M.R. in a high-risk category for peri-operative stroke. Respondent performed a right carotid endarterectomy on Patient M.R. on November 27, 2000. This requires the clamping of the artery in two locations, using a shunt to allow for the flow of blood. The incision must be made length wise in the controlled portion of the artery using an instrument to clear out the interior or lumen of the artery. This is done to reduce the stenosis and allow for better blood flow, without disbodying any particle from the wall of the artery. Once this is completed, the incision is patched, the clamps and shunt are removed, and the outer skin incision is closed. During the course of the above-described carotid endarterectomy, Respondent used a patch angioplasty with intra- operative shunt, which was manufactured from a pediatric feeding tube, and peri-operative neurologic monitoring. Immediately after the operation, the patient appeared to tolerate the procedure well, but was lethargic. Patient M.R. exhibited good movement in all four extremities and appeared to be neurologically intact, although he underwent extreme fluctuation in blood pressure. Patient M.R. was placed on ventilator support. The next morning, November 28, 2000, Patient M.R. had swelling and a hematoma in his neck on the right side, in the area of the incision. Respondent returned Patient M.R. to surgery, for exploration and evacuation of the hematoma. During the course of this second operation, Respondent observed a lot of swelling and edema in the operative site, but not much blood. Respondent evacuated the hematoma, and the carotid artery was found to have good blood flow. Later in the evening on November 28, 2000, Patient M.R. developed an acute neurologic deficit and was returned to the intensive care unit (ICU) at ORMC. Respondent ordered a Computerized Tomographry Scan (CT Scan) of the patient and an arteriogram. The results of the CT Scan showed a probable right occiptal infarct (stroke). The arteriogram showed significant occlusion of the right carotid artery extending to the carotid siphon. Patient M.R. was returned to the operating room in the early morning hours of November 29, 2000. Respondent made the decision to reopen the surgical area in an effort to resume blood flow in the right carotid artery that was seen to be occluded on the angiogram. Assisting Respondent on this November 29, 2000, procedure were John Horowitz, M.D., a board- certified vascular surgeon with nine years of experience, and Joseph Muller, M.D., a third-year general surgical resident at ORMC. During the November 29, 2000, procedure, Respondent reopended the previous incision in the skin and partially opened the patch that had previously been used over the carotid artery itself. Respondent performed a thrombectomy using a Fogarty "balloon" catheter in an effort to extract any debris that was causing the stenosis in the carotid artery. The balloon is placed into the carotid artery itself and is pushed up into the artery until it has passed whatever occlusion is present. Then the balloon is inflated and pulled back out, pulling with it any debris that is located within the artery. Near the conclusion of this November 29, 2000, procedure, a small piece of tubing was discovered in the surgical field. The piece of tubing was handed to Dr. Horowitz, who examined it and then placed it on the surgical tray. This piece of tubing was the same size, slope, and material cut from the feeding tube which was used as a shunt in the first surgery on November 27, 2000. There is conflicting testimony regarding the precise size and location of this piece of tubing that will be discussed below. What remains undisputed based upon the record in this case is that Respondent completed the surgical procedure on November 29, 2000, by closing the incision in the carotid artery and also in the skin of the neck. Dr. Muller is currently a surgical resident at ORMC, as he was at the time of the November 29, 2000, procedure. Dr. Muller testified that he had approximately two years and five months of residency training prior to the procedure in question. He estimated that he had observed approximately ten to 15 carotid endarterectomies. Dr. Muller testified that he observed a clear and slightly opaque piece of pediatric feeding tube coming out of the lumen of the artery as Respondent was evacuating debris after the inflation of the Fogarty balloon catheter and after about three passes of the catheter. Dr. Muller also testified that the piece of tubing in question was two or three centimeters in length. The other witnesses to this event testified that the piece in question was two to three millimeters in length. Dr. Muller's description of the position of the surgeon and assistant surgeon was also contrary to that of the other witnesses. Dr. Muller also testified that he did not know Patient M.R.'s medical history or his previous hospital course of treatment. Dr. Horowitz, the senior physician assisting, is a board-certified vascular surgeon who has performed several hundred carotid endarterectomies. He testified that he was called in by Respondent to assist on the surgical procedure which took place in the early morning hours of November 29, 2000. He found the piece of tubing located somewhere within the surgical field, remote from the carotid artery. He was certain that it was after Respondent had cleared the artery with the use of the Fogarty balloon catheter and had cleared the surgical wound. Dr. Horowitz testified that he saw a piece of tubing among the debris that had been evacuated from the surgical wound. It was not in the lumen of the artery. He picked up the piece of tubing in question with his thumb and forefinger and examined it. He testified that it was approximately two to three millimeters in length. He agreed that the material was consistent with the pediatric feeding tube that was used to create a shunt for the first procedure. Dr. Horowitz's testimony is credible and persuasive. Dr. Horowitz also gave his opinion that based upon his observation of the November 29, 2000, procedure, he did not believe that Respondent deviated from the standard of care in his treatment and care of Patient M.R. Patient M.R. was returned to the ICU, where he deteriorated and showed evidence of complete lack of brain stem reflexes. Patient M.R. was later pronounced brain dead, and he subsequently died on November 30, 2000. Gregory Schreiber, M.D., was the anesthesiologist who was present for a portion of the November 29, 2000, procedure. Dr. Schreiber testified that he was present during the beginning portion and the end portion of the procedure, when anesthesia is introduced and when anesthesia is abated. He was not present in the operating room when the piece of tubing was found. Further, there was a drape that separates the operative field from the anesthesiologist during the course of this procedure, which would have prevented Dr. Schreiber or his assistant from being able to see into the operative field directly. Dr. Schreiber noted that Patient M.R. was considered a very high-risk patient, whose multiple co-existent diseases posed a constant threat to his life when he presented for this surgery. In addition to the testimony outlined above, Petitioner also introduced three affidavits into evidence. One affidavit was that of Lata Bansal, M.D., a neurologist who was brought in for consultation after the November 29, 2000, procedure. Dr. Bansal swore in her affidavit that when she first saw Patient M.R. he was already brain dead. She otherwise did not have specific recollection of Patient M.R. The affidavit of Peter D. Taylor, M.D., a cardiac specialist, stated that he recommended a Thallium stress test for Patient M.R. prior to carotid surgery. The stress test was conducted on October 17, 2000, and revealed no ischemia but moderately decreased left ventricle function. Because he had no ischemia, Dr. Taylor opined that Patient M.R. was at an increased but acceptable risk for carotid surgery. The affidavit of Marita Lu, Registered Nurse, who was present during the November 29, 2000, procedure, stated that she could remember very few details of Patient M.R.'s case, other than she has the "impression" that something was recovered from the wound and that when she asked whether there was a specimen, she was told there was no specimen. Nothing in her affidavit indicates to whom she asked this question regarding the specimen nor is there any indication who responded to her question. Respondent is a board-certified general surgeon who is eligible for a special certification in vascular surgery and who was working at a vascular surgery group in Orlando, Florida, as of October and November of 2000. Respondent no longer practices in the State of Florida. He currently is an assistant professor of surgery and director of endovascular surgery at Creighton University in Omaha, Nebraska. Respondent described in detail each of the three procedures he performed. On November 27, 2000, the original procedure on the right carotid artery proceeded in routine fashion. Respondent provided an exemplar, which was admitted into evidence, of a pediatric feeding tube which is substantially similar to the pediatric feeding tube utilized in the November 27, 2000, procedure on Patient M.R. He utilizes a portion of the pediatric feeding tube as a shunt in his carotid endarterectomy procedures. He demonstrated at the final hearing that the pediatric feeding tube itself is so flexible as to be incapable of breaking. The only means of cutting it down is through the use of surgical instruments. He also indicated that there was no way to further cut down the tubing once it had been placed. The scrub technician cut the pediatric feeding tube into the appropriate length to be used as a shunt during the November 27, 2000, procedure. Respondent recalled that prior to this particular procedure, the tubing in question was not originally cut down to the appropriate size. It had to be cut down while in the operating room. It is during this cutting of the tubing that a tiny sliver, approximately two to three millimeters in length, was removed from the larger piece of tubing and entered the surgical field. Respondent did not know and did not have any way of knowing that the piece of tubing had entered the surgical field, as he was focused on preparing the artery itself for its incision while this tubing was cut. Respondent testified that the pediatric feeding tube in question was cut down to size before any incision was made in the carotid artery itself. Respondent performed the November 27, 2000, procedure as he normally does. After the procedure, Patient M.R. experienced extreme fluctuations in blood pressure. This can occur in patients due to multiple factors involving the nervous tissue and blood flow in the carotid artery, but there is no specific explanation for why it does happen. Subsequent to the November 27, 2000, procedure, Respondent monitored Patient M.R., addressing the extreme fluctuations in blood pressure along with the consulting physicians referred to above. Respondent noted that Patient M.R. developed a hematoma subsequent to the first procedure. He made a determination that the best course for Patient M.R. would be to evacuate the hematoma. In Respondent's opinion, evacuating the hematoma would speed up the healing process. Respondent performed this procedure on November 28, 2000. Patient M.R. tolerated this procedure well, and there was nothing remarkable about the procedure itself. Respondent palpated Patient M.R.'s artery during the course of this procedure and used the Doppler to reinforce his findings on palpation. A Doppler signal gives more specific information about the varied nature of blood flow in the internal and external carotid arteries. It was not Respondent's standard practice, nor is it necessary, to create a medical record that palpation of the artery has occurred, since it is such a basic and common occurrence that its notation on the record is not deemed to be necessary. Respondent continued to follow Patient M.R. subsequent to the November 28, 2000, procedure. When it was determined that Patient M.R. had suffered a stroke, Respondent was left with a choice of either doing nothing, or reopening the artery in an effort to save Patient M.R.'s life. Respondent chose to reopen the artery in an effort to determine whether anything could be done to save Patient M.R. Respondent opened the prior incision in the carotid artery on November 29, 2000, and inserted the Fogarty catheter in order to evacuate any debris that was located within the carotid artery. Respondent testified that it was at about this time that the piece of tubing was found; however, he further testified that he did not see the tubing in question come from the lumen of the carotid artery. Respondent's testimony is credible. It was Respondent's opinion testimony that the piece of tubing in question was located in the subcutaneous tissue outside of the artery. Its exact location within the various layers of subcutaneous tissue was not observed during the procedure. It was not possible for the piece of tubing in question to have entered the artery at this time. There was no evidence to suggest that the piece could have migrated into the artery at a later time. James Dennis, M.D., is a board-certified vascular surgeon who is the chief of the vascular surgery department at the University of Florida in Jacksonville, Florida. Dr. Dennis has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Dennis testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient M.R. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient M.R., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes. Dr. Dennis also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient M.R. Dr. Dennis' standard of care opinions were based on several factors. First, it was Dr. Dennis' opinion that based upon the contents of the chart, the only time that the piece of pediatric feeding tube could have entered Patient M.R. was during the course of the November 27, 2000, procedure. Dr. Dennis testified that in his opinion, Respondent deviated from the standard of care in allowing the piece of pediatric feeding tube to enter Patient M.R.'s body. This would be his opinion even if Respondent did not see the sliver of tubing in question enter Patient M.R.'s body and even if the piece of tubing in question were so small and translucent as to be practically invisible. Dr. Dennis also testified that in his opinion, Respondent deviated from the standard of care during the November 28, 2000, procedure in that he failed to adequately palpate the carotid artery. Dr. Dennis was critical of Respondent's use of a Doppler to assess Patient M.R.'s pulse. In Dr. Dennis' opinion, the use of the Doppler was indicative a weakening pulse rate and that the proper practice would have been to palpate the artery by touch rather than by using a Doppler instrument. Dr. Dennis was also critical of Respondent during the November 28, 2000, procedure for his failure to find the piece of tubing in question. It is Dr. Dennis' opinion that the piece of tubing had to have been located within the lumen of the artery and that had Respondent adequately palpated the entire length of the carotid artery during the November 28, 2000, procedure, he would have located the piece of tubing within the artery and could have taken appropriate steps to remove the piece of tubing before Patient M.R. suffered his stroke later that night or during the early morning hours of November 29, 2000. Dr. Dennis' opinion that the piece of tubing in question had to have been located in the lumen of the artery was also based upon his assessment of the procedures performed. He discounted the theory that the piece of tubing was located within subcutaneous tissue outside of the artery because, in his opinion, the piece of tubing would have been discovered either during the November 28, 2000, procedure or earlier in the November 29, 2000, procedure if it had been outside the artery. However, according to Dr. Dennis, based upon the timing of when the piece of tubing was found, the tubing itself had to have been located within the lumen of the artery until it was removed in the November 29, 2000, procedure. Dr. Dennis also rendered the opinion that not only was the piece of tubing located within the lumen of the carotid artery, but that the piece of tubing is directly related to the stroke which Patient M.R. suffered later that day or the following morning, which caused his death. Dr. Dennis testified that the piece of tubing became lodged in Patient M.R.'s carotid artery and that as blood flowed by it, platelets attached to the tubing, slowly building up with the carotid artery, until Patient M.R. experienced 100 percent stenosis in the right carotid artery, leading to his stroke. In sum, Dr. Dennis' opinion was that Respondent deviated from the standard of care by allowing a piece of tubing to enter Patient M.R.'s carotid artery and that it was this tubing which lead to Patient M.R.'s stroke and ultimately his death. This is in spite of the fact that Dr. Dennis was not able to state within any degree of medical probability how the sliver of tubing could have entered the artery. Dr. Dennis also rendered an opinion during his final hearing testimony that Respondent deviated from the standard of care because he did not secure the piece of tubing at issue in this case and see to it that the tubing was sent to the pathology laboratory at ORMC for analysis. Morris Kerstein, M.D., a board-certified vascular surgeon, reviewed all of the pertinent medical records reflecting the treatment and care Respondent provided to Patient M.R. Dr. Kerstein had been practicing for 35 years, and he is currently the chief of the vascular surgery department at the Veteran's Administration Hospital in Philadelphia, Pennsylvania. Dr. Kerstein has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Kerstein's opinion based upon his education, training, and experience is that Respondent did not deviate from the standard of care in his treatment of Patient M.R. First, Dr. Kerstein testified that in his opinion, Respondent's conduct during all three procedures at issue was appropriate. As to the November 27, 2000, procedure, there was no way for Respondent to be aware that the piece of pediatric feeding tube had entered the operative field. It was too small to be noticed, and it was of a translucent color which made locating it extremely difficult. He was not critical of Respondent for not cutting the tubing himself. He testified that if, in fact, the sliver of tubing entered the surgical area as a result of the scrub technician cutting the tubing, and a two to three millimeter fragment jettisoned into the surgical field, this would not constitute a deviation from the standard of care by Respondent. Dr. Kerstein testified that he felt the November 28, 2000, procedure was performed appropriately as well. He testified that it was not a deviation for Respondent to use a Doppler to feel for pulses in the arteries, and to the contrary, it reveals that Respondent was being meticulous beyond what the standard of care requires. He opined that Respondent certainly would have palpated the arteries in question, and to suggest otherwise based on the absence of a note to that effect is not an appropriate conclusion to draw. Dr. Kerstein rendered the opinion that he did not believe that the piece of tubing in question was located within the lumen of the artery of Patient M.R. He testified that there was no way for the tubing to enter the artery because the sliver in question came off of the longer tubing before an incision was made in the carotid artery. There is therefore no reasonable explanation as to how the piece in question could have entered the carotid artery in the first place. Dr. Kerstein also disputed the theory that not only was the piece of tubing located within the lumen of the artery, but also the piece in question actually caused Patient M.R.'s stroke. Dr. Kerstein relied principally on the radiographic studies. Both the CT Scan of the brain and the angiogram taken late in the evening of November 28, 2000, revealed a right posterior occipital infarct. The posterior of the brain is the back of the brain, and if the infarct was located there, it means that the cause of the stroke had to be something other than an occlusion in the carotid artery. This is because the arteries that feed the back portion of the brain are the basilar and vertebral arteries, not the carotid artery. Therefore, there could be no possible causal connection between the sliver in question and Patient M.R.'s stroke. Dr. Kerstein's opinion as to the cause of Patient M.R.'s stroke focused on his personal history rather than on the events of November 27, 2000. He noted that Patient M.R. presented with severe atherosclerotic changes, indicative of an advanced disease process. He noted that Patient M.R. suffered from chronic obstructive pulmonary disease, which was the product of his 54-year smoking history. He also noted Patient M.R.'s significant cerebrovascular disease. He also stated that thrombosis (or clotting of the blood) is a known complication of this procedure and can happen for several plausible reasons other than a sliver of tubing in the artery. All of these conditions conspired to predispose Patient M.R. to suffer a significant event such as the stroke he suffered on November 28 through 29, 2000. Dr. Kerstein also noted that the piece of tubing was completely inert, and given its size and its location in the subcutaneous tissue outside of the carotid artery, the tubing would have had no impact whatsoever on Patient M.R.'s prognosis. The tubing in question is an example of inert material that can remain inside the body, such as the case of a bullet which is located too close to the spinal cord to allow for an operation to remove it, without causing the body any harm. Dr. Kerstein had no criticism of the medical records Respondent kept regarding the treatment he provided to Patient M.R. He specifically noted that the records were accurate and honestly reflected what had occurred during the procedure. The fact that no foreign object was noted in the first two procedures was appropriate because at that point, he had no reason to suspect the presence of a foreign object. The lack of reference to a cause of Patient M.R.'s atypical post-operative course was appropriate because in fact Respondent could not have defined a single reason why Patient M.R. was reacting the way he did. Finally, the operative note from the November 29, 2000, procedure was appropriate, as it also honestly and accurately depicted what had occurred; he made a specific comment on Respondent's note that the sliver was not indeed from the lumen, but that the exact location was unclear, finding this to be an unambiguous statement of fact. Dr. Kerstein also disagreed with the state's position with regard to the responsibility for maintaining possession of the piece of tubing post-operatively. Dr. Kerstein testified that it was the responsibility of the circulating nurse, an employee of the hospital, to arrange for the piece of tubing to be sent to the pathology lab for examination. The evidence is insufficient to support Petitioner's contention that the pediatric feeding tube sliver at issue caused Patient M.R. to suffer a stroke because of its location within the carotid artery itself. Radiographic studies were performed on Patient M.R. after the stroke. A CT Scan performed on November 28, 2000, revealed an acute right posterior cerebral artery distribution infarct. Further, a cerebral angiogram was performed on November 28, 2000, and revealed "markedly diseased circulation particularly in the right vertebral and basilar arteries." This note also revealed: "Severely diseased posterior fossa circulation." Based upon the location of the infarct in Patient M.R.'s brain, the cause of the stroke had to have been either the vertebral or basilar arteries that supply blood to the posterior part of the brain. In view of all the evidence, the expert testimony of Dr. Kerstein, together with that of Dr. Horowitz, was more persuasive than that of Dr. Dennis in regard to the standard of care and Respondent's actions in this matter.
Recommendation Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated either Subsections 458.331(t) or (m), Florida Statutes, in his treatment of Patient M.R. and that the Administrative Complaint be dismissed. DONE AND ENTERED this 9th day of June, 2003, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2003. COPIES FURNISHED: Michael D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. 390 North Orange Avenue Suite 1000 Orlando, Florida 32802 Daniel Lake, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated August 30, 2000, 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 of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43 and Chapters 455 and 458, Florida Statutes (1997). Dr. O'Rourke is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 0044786. He has been in private practice in Fort Lauderdale, Florida, since 1985 and was board-certified by the American Board of Surgery in 1987 and re-certified in 1997. Dr. O'Rourke has been the Chief of Surgery at Broward General Medical Center since 1997. In early 1996, R.F., a 65-year-old woman, was referred to Dr. O'Rourke by Dr. Rajendra P. Gupta, a physician who had treated R.F. at the Broward General Medical Center Clinic ("Clinic") in 1995 and early 1996. The purpose of the referral was for a surgical consultation regarding a mass on R.F.'s liver. 1/ Dr. O'Rourke first saw R.F. at the Clinic on February 14, 1996, and on February 21, 1996, R.F. returned to see Dr. O'Rourke for preoperative testing. Dr. O'Rourke examined R.F., took a patient history, and ordered several preoperative tests. Dr. O'Rourke also reviewed R.F.'s medical records from the Clinic and her hospital chart from Broward General Medical Center ("Broward General"). These documents included, among other things, the record of prior consultations with physicians at Broward General, the films from a recent M.R.I. and a recent CT scan, and the results of a CT-guided biopsy, x-rays, sonograms, blood tests, and an esophageal endoscopy. The CT-guided biopsy did not confirm or rule out the possibility that the mass on R.F.'s liver was cancerous. However, because tests showed that R.F.'s alpha-fetoprotein levels 2/ were abnormal, Dr. O'Rourke considered the mass to be a cancerous tumor and, therefore, lethal. Based on the results of the tests ordered by Dr. Gupta and by Dr. O'Rourke and on the information in R.F.'s medical records and hospital chart, Dr. O'Rourke decided that it would be appropriate to perform an exploratory laparotomy on R.F. to evaluate the mass and, if indicated, perform a right hepatic segmentectomy, or resection, to remove the mass. Dr. O'Rourke explained the gravity of the situation to R.F. and told her that he wanted to perform exploratory surgery to determine if the mass on the liver could be removed and to remove it, if possible. R.F. discussed the proposed surgery with her family and notified Dr. O'Rourke that she would have the surgery. In deciding that an exploratory laparotomy was appropriate for R.F., Dr. O'Rourke considered and evaluated the risk that R.F. would have excessive bleeding during the procedure. The presence of significant cirrhosis of the liver is one indication that a patient might bleed excessively during a hepatic resection. 3/ The results of the esophageal endoscopy performed on R.F. in October 1995 did not show the presence of esophageal varices, nor did the results of R.F.'s CT scan show the presence of ascites. Both of these conditions are indicative of portal hypertension, which is increased blood pressure in the portal triad that provides blood to the liver. 4/ Portal hypertension is caused by a slowing of the blood flow through the liver, which is, in turn, caused by cirrhosis of the liver. Because there was no evidence of portal hypertension in R.F.'s test results, there was no conclusive preoperative evidence that R.F.'s liver was cirrhotic. 5/ Nonetheless, based on other indications in R.F.'s medical records and test results, Dr. O'Rourke considered it highly probable that R.F.'s liver was cirrhotic. R.F. was at high risk of cirrhosis because she had a positive hepatitis profile for Hepatitis B and C, because she had a probable primary cellular carcinoma in the liver, and because her outpatient medical records revealed a persistent elevation of cellular enzymes in her liver. However, the extent of R.F.'s cirrhosis could not be precisely determined through preoperative testing; it could only be conclusively determined intraoperatively. The more important consideration in Dr. O'Rourke's evaluation of R.F. as a candidate for an exploratory laparotomy and possible hepatic resection was the functional ability of R.F.'s liver. There was no preoperative evidence that R.F.'s liver function was abnormal; her PT levels and her bilirubin levels, both important indicators of liver function, consistently tested within the normal range. Dr. O'Rourke also considered the possibility that R.F.'s tumor was particularly vascular, 6/ which would also indicate that R.F. would bleed excessively during surgery. It is not possible to determine conclusively before surgery if a tumor is vascular; that determination can only be made once the tumor is visible and can be manipulated. However, there was no preoperative evidence that R.F.'s tumor was particularly vascular. R.F. tolerated a CT-guided biopsy of the liver prior to surgery; there was nothing in the biopsied tissue that indicated the tumor was particularly vascular, nor was there any significant bleeding as a result of the biopsy. This would indicate that R.F.'s tumor was not particularly vascular. Dr. O'Rourke did not request a preoperative cardiology consultation for R.F. because there were no indications of a cardiac risk in her medical records or in her test results. Although R.F. had diagnoses of systemic hypertension and of atrial fibrillation, both of which are very common, the hypertension was controlled by Accupril and a diuretic, and neither the hypertension nor the atrial fibrillation would indicate the need for a cardiology consultation. R.F.'s EKG was interpreted as borderline; and there were no indications in her medical records that R.F. had ischemic heart disease. In addition, the anesthesiologist who was to administer anesthesia to R.F. during the surgery did not request a cardiology consultation. 7/ Had the anesthesiologist been concerned about R.F.'s cardiac fitness to tolerate general anesthesia, he or she would likely have cancelled or deferred the surgery. The only documentation of the location of the hepatic mass that Dr. O'Rourke included in R.F.'s medical records was a notation that the indicated procedure was a right hepatic segmentectomy. However, even though Dr. O'Rourke did not more precisely set forth the location of the mass in the documentation, he knew the exact location of the mass from having examined the film of the CT scan and of the M.R.I. performed on January 3, 1996, which showed an "ovoid solitary mass along the dome of the right lobe of the liver." In addition, the report of the sonogram performed on November 21, 1995, which was available to and reviewed by Dr. O'Rourke, showed a "focal mass on the diaphragmatic surface of the right lobe of the liver." On February 27, 1996, Dr. O'Rourke performed exploratory surgery on R.F. to determine the resectability of the liver tumor. Ultimately, Dr. O'Rourke performed a non- anatomic hepatic resection to remove the tumor. Dr. O'Rourke prepared adequately for the possibility that R.F. would experience blood loss during the exploratory laparotomy. As noted above, however, there were no preoperative indicators that R.F. would experience excessive blood loss. Dr. O'Rourke requested that a cell saver be available in the operating room during R.F.'s surgery, 8/ and the anesthesiologist ordered R.F.'s blood to be typed and screened to identify the correct blood type. Dr. O'Rourke did not order R.F.'s blood to be typed and cross-matched, which provides the most specific information about the particular type of blood required by the patient. Although the better practice is to have the patient's blood typed and cross-matched prior to surgery, it takes only ten minutes to obtain typed and cross- matched blood from the blood bank should the patient lose more blood than can be replaced by the cell saver. 9/ R.F.'s blood pressure was monitored during the surgery by an arterial line, and good access was provided for the introduction of fluids into R.F. through two intravenous lines placed by the anesthesiologist, one 16-gauge line and one 18-gauge line. Dr. O'Rourke did not place a "central line," or central venous pressure ("CVP") line, 10/ into R.F. preoperatively. The anesthesiologist usually makes the decision to insert a CVP line preoperatively, and, in R.F.'s case, Dr. O'Rourke agreed with the anesthesiologist that it was not necessary. Some surgeons routinely insert CVP lines preoperatively when performing an exploratory procedure such as Dr. O'Rourke was performing on R.F.; other surgeons prefer to wait until they are sure that they will perform the hepatic resection because there are a multitude of risks attendant to the insertion of a CVP line, a bleeding pneumothorax being the most common. 11/ Dr. O'Rourke began the exploratory laparotomy by opening R.F.'s belly and removing scar tissue that resulted from prior surgery. He dissected into the abdomen, down to the fascia, and again removed scar tissue that resulted from prior surgery. He divided the falciform ligament and removed it at the point where it attaches to the liver, a procedure that is necessary before the liver can be mobilized. Dr. O'Rourke moved the falciform ligament further up to its diaphragmatic attachment so that he could have full access to the dome of the liver, where R.F.'s tumor was located. Once the falciform ligament was separated from the liver, Dr. O'Rourke palpated the tumor and determined that it was very fragile and tended to crumble. Dr. O'Rourke then mobilized R.F.'s liver. 12/ When he did so, the tumor ruptured, and R.F. started to bleed from the posterior of the liver. R.F.'s blood pressure fell dramatically, a condition known as hypotension, and she became unstable. Dr. O'Rourke's first priority was to stop the bleeding and stabilize R.F.'s blood pressure, and he decided to pack the liver, the most extreme technique used to stop bleeding in or around the liver. Unfortunately, once a patient undergoing hepatic surgery begins to bleed, it is very difficult to stop the bleeding. 13/ The Pringle maneuver is one technique that can be used to control bleeding in and around the liver. This technique requires dissecting around the portal triad and clamping the hepatic artery and the portal vein in order to stop temporarily the blood flow from the portal triad into the liver. Dr. O'Rourke's decision to pack R.F.'s liver rather than attempt the Pringle maneuver was based on several factors. First, R.F. had a significant amount of scar tissue on her anterior abdominal wall, and Dr. O'Rourke anticipated that, given her rapidly deteriorating condition, it would take too much time to dissect through the scar tissue to expose the portal triad. Second, the Pringle maneuver provides only a temporary solution because the portal triad can be clamped and the blood flow into the liver stopped for no more than 15 minutes at a time; the maneuver can be repeated if necessary when working with a healthy liver but it is very risky to do so when working with a cirrhotic liver such as R.F.'s. Third, although it can be helpful to a surgeon trying to find the source of bleeding to temporarily stop the blood flow from the portal triad, Dr. O'Rourke already knew that the bleeding originated in the posterior of the liver, behind the tumor. At the same time that Dr. O'Rourke was packing the liver, the anesthesiologist was resuscitating R.F. with fluids and calling the blood bank to order cross-matched blood. After packing the liver, Dr. O'Rourke observed the site of the bleeding for 15 to 20 minutes, during which time the bleeding decreased slightly but not significantly. R.F.'s parameters did not improve, and Dr. O'Rourke decided to close the abdomen. After closing the abdomen, Dr. O'Rourke inserted a CVP line; the CVP line was inserted primarily for the purpose of more quickly introducing fluids and blood products into R.F. Once he had placed the CVP line, Dr. O'Rourke assisted the anesthesiologist in attempting to resuscitate R.F. by the rapid infusion of fluid and blood. At this point, Dr. O'Rourke anticipated that R.F. would stabilize, and, once she had stabilized, Dr. O'Rourke intended to wait 24-to-48 hours, reopen the abdomen, remove or replace the lap packing, and close the abdomen without removing the tumor. He decided that, when he re-opened the abdomen, it would be too risky to proceed with the tumor resection because of the likelihood that R.F. would again begin bleeding. Dr. O'Rourke's plans changed because R.F.'s blood pressure did not significantly improve after approximately 20 minutes, and the degree of her hypotension was out of proportion to her actual blood loss, which Dr. O'Rourke estimated as 300- to-400 cubic centimeters. Under these circumstances, Dr. O'Rourke felt that he had two alternatives: to do nothing and let R.F. die or to re-explore the liver. He, therefore, re- opened the incision, removed the packing, and confirmed that the packing had not controlled the bleeding. When packing fails to control the bleeding, the surgeon has a serious problem and a limited number of options: The surgeon can temporarily stop the flow of blood into the liver by using the Pringle maneuver; the surgeon can extend the incisions under the ribs or into the side and fully mobilize the liver 14/ to expose its posterior and possibly locate the source of the bleeding; or, the surgeon can remove the tumor to try to gain access to the vessels that are bleeding so that they can be suture-ligated. Dr. O'Rourke had already rejected the Pringle maneuver as too time-consuming and unlikely to be successful in stopping the bleeding. He decided not to fully mobilize the liver because R.F.'s liver was cirrhotic, and therefore somewhat brittle, so that, had he attempted to mobilize the liver fully, he risked exacerbating the bleeding. In any event, the tumor was completely accessible to Dr. O'Rourke without fully mobilizing the liver. Dr. O'Rourke decided that, under the circumstances, the best chance of saving R.F. was to remove the tumor, thereby gaining access to the posterior of the liver and to the hepatic veins, which he suspected were the source of the bleeding. Once the tumor was removed, he could suture-ligate the blood vessels from which the bleeding originated. Accordingly, Dr. O'Rourke performed a non-anatomic hepatic resection. He found that the tumor resection itself was easy and presented no problems. He individually suture-ligated the vessels that provided the tumor's blood supply and brought the bleeding down to a low level. Dr. O'Rourke felt that he had controlled the bleeding, and R.F.'s hepatocrit level was brought back to a low-normal, but acceptable, level. Nonetheless, R.F.'s blood pressure did not improve and actually deteriorated. Despite the successful efforts to control the bleeding and the efforts to resuscitate R.F. by transfusing blood and fluids, her condition continued to deteriorate, and she was pronounced dead at 6:23 p.m. on February 27, 1996. Dr. O'Rourke spoke with R.F.'s family and told the family members that the amount of R.F.'s blood loss did not explain why her blood pressure fell so low or why her condition continued to deteriorate in spite of his having controlled the bleeding and in spite of the efforts to resuscitate her with blood and fluids. He asked the family for permission to do an autopsy to determine what had happened. The family refused, although they later had a private autopsy done at Jackson Memorial Hospital in Miami, Florida. The cause of death stated in the autopsy report was "[e]xsanguination post subtotal hepatic resection." The evidence submitted by the Department is not sufficient to establish with the requisite degree of certainty that Dr. O'Rourke failed to keep adequate medical records to justify the course of his treatment of R.F. Because R.F. was a Clinic patient, Dr. O'Rourke had access to the medical records kept since her first consultation with Dr. Gupta in October 1995, as well as access to all of the results of the tests performed on her from October 1995 through the date of surgery. In the record of his examination of R.F., Dr. O'Rourke included her surgical history, her medical history, a list of the medications R.F. was taking, and the results of his physical examination of R.F. His proposed treatment of R.F. was identified in the documentation as a right hepatic resection. Taken altogether, the documentation in this case adequately justifies Dr. O'Rourke's decision to do an exploratory laparotomy and a right hepatic resection, if indicated, and there is no evidence that additional documentation was required. 15/ The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. O'Rourke's preoperative examinations, testing, or planning fell below that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. R.F.'s medical records and chart establish that she was given a battery of pre-operative tests, and the Department's expert witness could not identify any additional pre-operative test that should have been given. Dr. O'Rourke examined the patient and noted the results of his examination, as well as the medications she was taking, on the Outpatient/Short Stay Record. Dr. O'Rourke knew the exact location of the mass on R.F.'s liver, he adequately noted the location of the tumor as the right posterior lobe of the liver, and he knew that, although R.F.'s liver was most likely cirrhotic, her liver function was normal, albeit low normal. A pre-operative cardiology consult was not indicated by R.F.'s medical records or test results. It is uncontroverted that Dr. O'Rourke's decision to do an exploratory laparotomy on R.F. was not inappropriate. Dr. O'Rourke anticipated that R.F. would suffer blood loss during the surgery, and he planned for the anticipated blood loss by ordering a cell saver for the operating room. Although Dr. O'Rourke perhaps should have had R.F.'s blood typed and cross-matched prior to the surgery, his failure to do so did not appreciably delay the delivery of additional blood to R.F. The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. O'Rourke's intraoperative efforts to control R.F.'s bleeding fell below that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Dr. O'Rourke's decisions to pack the liver to control the bleeding and then, when that failed, to remove the tumor in an effort to expose the vessels that were bleeding were not inappropriate under the circumstances. Although there were options other than packing available to help control the bleeding, Dr. O'Rourke rejected these options as too time- consuming, as temporary solutions, as unnecessary, or as unlikely to be successful. Dr. O'Rourke's decision to remove the tumor to gain access to the vessels that were the source of the bleeding and to attempt to stop the bleeding by suture- ligating these vessels was a decision that could only have been made intraoperatively, based on all of the information available to Dr. O'Rourke at the time. Although R.F. was very unstable, the cell-saver was recycling the blood she was losing and re- infusing it, and R.F. was receiving other blood products and fluids. Given the available options, Dr. O'Rourke's decision was not inappropriate.
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 the Administrative Complaint against Aiden Matthew O'Rourke, M.D. DONE AND ENTERED this 26th day of January, 2001, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2001.
The Issue The matter presented for consideration in this case concerns an Administrative Complaint brought by the Petitioner against the Respondent calling for revocation, suspension or other disciplinary action against the Respondent's license as a medical doctor practicing in the State of Florida. By Count I to the Administrative Complaint, the Respondent is charged with prescribing Eskatrol (dextroamphetamine) an amphetamine or sympathomimeticamine or compound designated as a Schedule II controlled substance under Chapter 893, Florida Statutes, for the benefit of Susan Baldwin, for the alleged treatment of weight control for that patient and for that reason, has purportedly violated Subsection 458.331(1)(cc) , Florida Statutes (1980). Count II to the Administrative Complaint alleges that on the facts set forth in Count I the Respondent has failed to prescribe the aforementioned controlled substance for a medically justifiable purpose, in that the prescription was inappropriate or in excessive quantities. For these reasons, Count II alleges that the Respondent has violated Subsection 458.331(1)(q) , Florida Statutes (1979), by prescribing a controlled substance other than in the course of his professional practice. Count III to the Administrative Complaint alleges that on August 4, 1980, the Respondent prescribed Fastin (phentermine) , a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for the benefit of Linda Sapp, without conducting a physical examination and by doing so, failed to prescribe the substance for a justifiable purpose, in that the prescription was inappropriate or in excessive or inappropriate quantities. For this reason, the Respondent is alleged to have violated Subsection 458.331(1)(q), Florida Statutes (1979), for failing to prescribe a controlled substance other than in the course of his professional practice. Count IV to the Administrative Complaint alleges that, in keening with the facts as set out in the allegations in Count III, Respondent has violated Subsection 893.05(1), Florida Statutes, for failing to prescribe a controlled sub- stance in good faith and in the course of his professional practice, by such action he is further accused of violating Subsection 458.331(1)(h) , Florida Statutes (1979). Count V to the Administrative Complaint pertains to the patient Susan Baldwin and under the facts as set forth in Count I, it is alleged that the Respondent has violated Subsection 458.331(1)(1), Florida Statutes (1979), in making deceptive, untrue or fraudulent representations in the practice of medicine or employing a trick or scheme in the practice of medicine. The Petitioner has provided a Proposed Recommended Order and argument. This matter has been considered prior to the entry of this Recommended Order. To the extent that the proposal is consistent with this Recommended Order, it has been utilized. To the extent that the proposal is inconsistent with this Recommended Order, it is hereby rejected.
Findings Of Fact Case History This cause is presented for consideration based upon the Administrative Complaint alluded to in the Issues statement of this Recommended Order, which was brought by the State of Florida, Department of Professional Regulation, Petitioner, against Manuel M. Maralit, M.D., Respondent. When confronted with this Administrative Complaint, the Respondent was apprised of his right to a formal hearing and elected to proceed in defense of this matter, in keeping with the provisions of Subsection 120.57(1), Florida Statutes (1979). The matter was then referred to the State of Florida, Division of Administrative Hearings for the conduct of a formal hearing, and on July 24, 1981, the formal hearing was held. In the course of the formal hearing, the Petitioner offered the witnesses, Elizabeth P. Piazza, Linda Sapp, and Barry Bleidt, together with it's Exhibits Nos. 1 through 4. All exhibits were admitted with the exception of Exhibit No. 3. The Respondent testified in his own behalf and offered two exhibits which were admitted. In addition to the in hearing testimony and presentation of exhibits, the depositions of doctors Robert P. Johnson and Charles Fletcher were admitted as a part of the record as Petitioner's Exhibits Nos. 5 and 6, respectively. Material Facts On September 13, 1978, the Florida State Board of Medical Examiners issued Manuel M. Maralit, M.D., a license to practice medicine in the State of Florida. The license number is 33337. At all times pertinent to the inquiry, Dr. Maralit has been the holder of this license. Dr. Maralit graduated from Manila Central University of the Philippines. Following his graduation, he took postgraduate training in the Medical Center of Central Georgia, in the State of Georgia. He has practiced medicine since 1967, and began his practice in the State of Florida some time in 1978 or 1979. The practice in the State of Florida has been in the communities of Keystone Heights and Starke. On July 22, 1980, Dr. Maralit saw and treated one Susan Baldwin. At the time of this visit, the patient was 5' 3" tall, weighed 170 pounds, had a temperature of 98.30F, pulse rate of 86, respiration 20, and blood pressure 140/90. The date of birth of the patient was December 28, 1944. The patient complained of weakness, of sluggishness, of easy fatigability, and of continued and persistent sleepiness. She was found, upon examination by Dr. Maralit, in the area of head, ears, eyes, nose and throat, to be normal. He also found, upon examination, that her heart and lungs were normal. Upon this visit, Dr. Maralit was of the persuasion that the patient had possible narcolespy and was slightly overweight. She had been taking Eskatrol (spansule) under the prescription of a Dr. Henry, her former treating physician. Dr. Maralit, on July 22, 1980, continued to prescribe the Eskatrol by indicating that the patient should take one tablet daily for thirty days. In addition, he prescribed Unicam, to be taken one daily. The Eskatrol which was prescribed at that point was related to weight control. On November 10, 1980, the same Susan Baldwin presented a prescription for Eskatrol, in the amount of thirty tablets, which prescription was issued by Dr. Maralit on that same date. A copy of the prescription may be found as the Petitioner's Exhibit No. 2, admitted into evidence. The pharmacist who received the prescription was one Elizabeth Piazza. Piazza asked Baldwin what the Eskatrol prescription was for and Baldwin replied that it was for Baldwin's weight. Piazza then told Baldwin that Eskatrol could no longer be prescribed for weight control and indicated that it would be necessary for Piazza to call Dr. Maralit. The patient was told to come back later because Piazza was unable to contact Dr. Maralit on November 10, 1980. Piazza did speak with the Respondent a day or so later. Piazza told Maralit that Eskatrol could no longer be prescribed for weight control and that she had such a prescription from Susan Baldwin, his patient. Maralit said that he knew that you cannot prescribe Eskatrol for weight control but when he told patients who came to him and asked him for the substance that they could not have it, the patient would not believe him. He further stated that he knew that the pharmacist, upon getting the prescription, would call him and get the Eskatrol prescription changed to something else. During the course of the discussion, Piazza indicated her belief that the law would not allow Eskatrol to be prescribed for the treatment of obesity. A discussion was then entered into between Maralit and Piazza in which Maralit determined that Fastin could be substituted for the Eskatrol prescription which was to be given to Susan Baldwin. (Fastin is a substance with the specific purpose of treating obesity.) The Fastin which was substituted was then dispensed to the patient Baldwin. As a part of his practice, Dr. Maralit conducted certain activities in the Union General Hospital in Lake Butler, Florida. This was in the year 1980. One of the employees in that hospital who was an X-Ray Technologist, was one Linda Sapp. She was acquainted with Dr. Maralit in terms of the involvement of their two professions in the treatment of patients, but was not a social friend, nor a patient of Dr. Maralit's on August 4, 1980. On that August date, she encountered Dr. Maralit in the hall and asked for him to write a prescription for Fastin. The witness testifying in the hearing did not recall telling Dr. Maralit why she wanted that medication and the other facts in the hearing do not establish that she gave any reason for asking for Fastin. In her own mind, she wanted the Prescription as an energy boost to allow her to conduct her job and raise her three (3) children. Dr. Maralit, in response to the request, went to the emergency room desk in the hospital and wrote a prescription for Fastin, a copy of which may be found as Petitioner's Exhibit No. 4, admitted into evidence. The prescription was written for thirty (30) capsules and was dispensed as a Gold Line item, known as a generic substitute. That generic substitute was phentermine hydrocloride. The only instruction on the prescription container was to the effect, "take 1 capsule daily." The patient Sapp took one (1) capsule every other day until the prescription had been exhausted. There was never a refill of the prescription, although under the original prescription Sapp could have refilled the prescription one (1) time. Sapp felt that the substance prescribed in substitute for Fastin did give her an energy boost and she experienced no side effects from the drug, although she was unfamiliar with the pharmacological effects, physical effects or psycho-logical effects that might be caused by the utilization of that chemical. Maralit never, in the course of prescribing this medication for Sapp, asked the patient if she was taking other medication. In fact, in August of 1980, she was not taking other medications. Maralit was not paid for his services. On August 4, 1980, the patient's weight was approximately 140 pounds and she continued to weigh that amount at the time her testimony was given in the course of this formal hearing. She did not indicate her height when Dr. Maralit prescribed the medication, nor did she indicate whether she had any form of heart or hypertension problems. No medical history Was otherwise taken and no physical examination was made of the patient on August 4, 1980, before prescribing the generic substitute for Sapp. Finally, neither Dr. Maralit nor the patient ever discussed the fact that the drug Fastin had as its express purpose the control of weight. Dr. Robert J. Johnson, a medical doctor licensed by the State of Florida, testified through deposition. Dr. Johnson is a physician who has practiced medicine for approximately twenty-five (25) years with a specialty in family practice. Dr. Johnson's testimony established the fact that Eskatrol carries the generic name dextroamphetamine sulphate and prochlorperazine. The drug Eskatrol is an amphetamine, as revealed by Dr. Johnson. Dr. Johnson's testimony also established that narcolepsy is a condition where the patient has an imbalance of his sleep mechanism where he will go into episodes of sleep in an uncontrolled manner. The Johnson testimony established the fact that there is no relationship between the medical diagnosis of narcolepsy and the establishment of a weight loss program or treatment of obesity. Per Johnson, Eskatrol is a proper medication for the treatment of narcolepsy. To diagnose narcolepsy, one must have a valid history from the patient, based upon observations of peers and family in which the patient has been seen to have episodes of uncontrolled sleep. The utilization of an electroencephalogram over a 24-hour period would be a strong indication and a routine electroencephalogram would be some indication of a problem with narcolepsy, as stated by Johnson. Dr. Johnson also revealed that the drug Fastin is known generically as phentermine hydrocloride. By referring to the Physician's Desk Reference, Johnson's testimony established that: Fastin is a sympathomimetic amine with activity similar to the prototype drugs of this class used in obesity; namely, the anphetamines [sic]. Actions include central nervous system stimulation and evaluation [sic] of blood pressure. Tachyphylaxis and some tolerance has been demonstrated with all of these drugs. Used in obesity, and com- monly known as anorectics. It has been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects may be involved. Adult obese patients instructed in dietary manage- ment and treatment with anorectic drugs lose more weight on the average than those treated with placebo or diets, it has been shown. The drug is indicated in the management of exogenous obesity as a short-term-just a few weeks-adjunct in a regimen of weight reduction with caloric restriction. It's contraindications are advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy of the symoathomimetic amines, glaucoma, agitated states. Patients with a history of drug abuse. During or within 14 days following the administration of monoamine oxidase inhibitors. Under warnings listed in the PDR, it says, 'Tolerance to the anorectic effect usually develops within a few weeks.' You may have to discontinue the drug. It is related chemically and pharmaco- logically to the anphetamines [sic]. Since the anphetamines [sic] and related stimulant drugs had been extensively abused, the possibility of abuse of Fastin should be kept in mind when evaluating the desireability [sic] of including a drug as part of a weight reduction program. Abuse of anphetamines [sic] and related drugs may be associated with intense psychological dependence and severe social dysfunction. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes has [sic] been noted in sleep EEG's. Manifestations of chronic intoxi- cation with anorectic drugs includes severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. It must be used with great care in pregnancy. It is not indicated in children under the age of 12. Caution is to be exercised in pre- scribing Fastin for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of Fastin and the concomitant dietary regimens. It may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed. As far as adverse reactions: Palpitation, tachycardia, elevation of blood pressure. To the central nervous system: Overstimula- tion, restlessness, dizziness, insomnia, euphoria, disphoria, tremor, headache; rarely psychotic epidoes even at the recommended dosage. Gastrointestinal side effects: Dryness of the mouth, unpleasant taste, diarrhea, constipation and other GI disturbances. Some people may experience urticaria, an allergic reaction to it. It can also cause impotence and changes in libido. Johnson correctly asserts that before prescribing Fastin, minimum medical examination should be conducted on a patient. Johnson would question the patient about the patient's medical history, whether there have been serious medical problems in the past, particularly along the lines of cardiovascular problems or problems with the central nervous system. He would question the patient about diabetic problems or symptoms of diabetes and whether there is any diabetes in the family. A physical examination of the heart and lungs, in the sense of listening, and a check of blood pressure and pulse should be done and the patient should be weighed. These checks are in keeping with the proper steps to be taken prior to prescribing Fastin. Dr. Johnson would also conduct a urinalysis to determine if glycosuria was present. Dr. Johnson's testimony established the fact that Fastin has no other medical indication than weight control. Dr. Johnson's testimony reveals that it is inappropriate for a practitioner in the State of Florida, that is to say an indication that the practitioner is practicing without the level of care, skill and treatment recognized by reasonably prudent similar physicians under similar conditions and circumstances if Fastin were to be prescribed for a patient that has never been seen before, on whom the doctor did not conduct a physical examination or take a history from that patient nor ask or receive information as to what the patient needed the medication for, such as was the case between Dr. Maralit and the patient Sapp. By doing so, the patient is subjected to hazards that may be related to blood pressure problems, pulse, hyperexcitability states, potential drug abuse, hyperthyroidism states and possible problems with hypoglycemia, as established by Dr. Johnson. As established by Dr. Johnson, this act by Maralit of prescribing Fastin to a patient never seen before, whom the physician had never conducted a physical examination and did not take a history from or seek other pertinent information as to why the patient needed medication, was an inappropriate act, not the act expected of a practitioner with a level of skill, care and treatment recognized by reasonably prudent similar physicians under similar conditions and circumstances. Again as established by Dr. Johnson, a physician who prescribes Fastin absent physical examination, taking a history and explanation for why the medication was needed, would be the act of prescribing a scheduled controlled substance in a way not in the course of his professional practice and in good faith. In this instance, Dr. Maralit's treatment of Sapp fits this hypothetical fact pattern. Dr. Charles Terry Fletcher, a medical doctor licensed in the State of Florida, gave testimony. Dr. Fletcher has been licensed since 1965, and in addition to his medical degree, has a degree in pharmacy. He has practiced in Gainesville, Florida, for a period of seventeen (17) years, primarily in family practice or general practice. Dr. Fletcher, through his testimony, establishes that Fastin is used in the treatment of obesity when the utilization of a diet is unsuccessful standing alone. At that moment, Fastin might be used to assist in the loss of weight together with the diet, as established by Dr. Fletcher. Dr. Fletcher's procedure for minimal observation before prescribing Fastin, which is accepted as accurate, would entail the taking of a history from the patient to determine if there is a problem with hypertension, chest pain, cardiac disease, thyroid or a vascular disease. It would also entail an examination of the thyroid gland, auscultation of the heart and lungs, a blood pressure check, measurement of height, the taking of weight, and an examination of the abdomen to determine any organomegaly in the abdomen. As established by Dr. Fletcher, the reason for taking the history and making these physical checks is to determine whether Fast in is contraindicated due to some preexisting conditions, such as myocardial disease, heart attack, angina, hypertension, arteriosclerosis of a moderately advanced nature, thyroid toxicosis or hyperactive thyroid gland. It also is necessary to determine if the patient is habituated to any drug such as Fastin. These matters are important according to Dr. Fletcher because of the possible side effects of the drug Fastin, including increased anxiety and tension, insominia, palpatations or tachycardia, rapid heart rate. Dr. Fletcher has correctly agreed with Dr. Johnson's perceptions on the propriety of prescribing Fastin without conducting the physical examination or taking a history or receiving information as to the patient's need for the medication.
Recommendation Based upon a full consideration of the matters in this case, it is hereby RECOMMENDED: For violations as proven in Counts I, II, and V, the Respondent shall have his license to practice medicine in the State of Florida suspended for a period of thirty (30) days for each Count, to run concurrently. For the violations as established through Counts III and IV, the Respondent shall have his license to practice medicine in the State of Florida suspended for a period of sixty (60) days for each of those Counts, running concurrently as to Counts III and IV, but consecutive to the penalty imposed in Counts I, II, and V, however, the suspension penalty imposed in Counts III and IV be withheld pending the satisfactory completion of a probationary period of one (1) year, beginning at the expiration of the service of suspension for Counts I, II, and V. In probation the Respondent shall specifically complete twenty-four (24) classroom hours of continuing medical education in the area of pharmacology and shall comply with such other terms and conditions as are deemed reasonable by the Board of Medical Examiners, to include limitations on the Respondent's ability to prescribe and dispense scheduled controlled substances under Chapter 893, Florida Statutes, and other reasonable reporting requirements associated with this probationary status. DONE and ENTERED this 16th day of October, 1981, in Tallahassee, Florida. CHARLES C. ADAMS, 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 16th day of October, 1981. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Deputy General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wayne Carroll, Esquire 1155 N. W. 1st Avenue Lake Butler, Florida 32054
The Issue Whether respondent should grant petitioner's application for a certificate of need for a ten-station chronic hemodialysis center in Broward County?
Findings Of Fact At the time petitioner's application was originally submitted, an unmet need for hemodialysis facilities appeared to exist in Broward County. The project review committee and the board of directors of the Health planning and Development Council for Broward County, Inc., recommended denial of petitioner's application and of all applications for new facilities, however. Competing applicants seeking to expand and establish a satellite were awarded certificates of need because their personnel had proven track records. Petitioner's application was tentatively denied, not because it was deficient, but because competing applications were deemed stronger. With the approval and addition of hemodialysis units since that time, Broward County has become saturated with dialysis centers, and now has significant excess capacity. As of January 1, 1981, there were eight dialysis centers in Broward County, which is coterminous with the jurisdiction of the Health Systems Agency for respondent's District VIII, the Health Planning and Development Council for Broward County, Inc. These eight dialysis facilities had, in the aggregate, 125 approved stations, as of January 1, 1981. Five free-standing stations have since been approved for Plantation Artificial Kidney Center. Respondent's Exhibit No. 3. Countywide, the 125 hemodialysis stations then existing had a utilization rate of 67 percent in January and February of 1981, winter months in which Broward County experiences an influx of seasonal residents. On January 31, 1981, there were 29 seasonal hemodialysis patients in Broward County and, on February 28, 1981, there were 38. Respondent's Exhibit No. 1. Broward County has a population of approximately one million persons. Using the formula prescribed in respondent's rules, Florida End Stage Renal Disease Network 19 projected that 353 patients would require in-center dialysis in 1980, while in fact only 339 patients required dialysis outside their homes. This need could have been met with 106 stations, on the basis of 3.2 patients per station, instead of the 125 stations that existed in Broward County in fact in 1980. For December of 1981, the projection is that 349 patients will require 109 stations; for December of 1982, it is projected that 359 patients will require 112 stations; and for December of 1983, it is projected that 371 patients will require 116 stations, on the basis of 3.2 patients per station. Respondent's Exhibit No. 3. Customarily, dialysis centers are open for business six days a week, with each machine available for two shifts daily. Dialysis usually entails three sessions weekly for the patient so that, if fully utilized, one machine could service four patients. Approximately ten hemodialysis stations in Broward County are set aside for patients with hepatitis positive antigens. These isolation stations are not ordinarily fully utilized. On this account and because of seasonal changes in the numbers of hemodialysis patients in Broward County, the health systems plan looks to an 80 percent utilization rate (on the basis of two shifts a day, even though the machines could he used for three shifts daily in an emergency). This utilization rate translates into 3.2 patients per machine. Another objective of the health system plan is that 95 percent of patients be within 30 minutes of a hemodialysis center. The annual implementation plan calls for 132 stations by December of 1982, without adding any new centers. Dialysis patients in south Florida are older than dialysis patients in north Florida, on the average. Most dialysis patients in Broward County are more than 50 years old. In 1978, Broward County's increase in patients with end stage renal disease was the highest among [Florida's] HSA areas. Petitioner's Exhibit No. 4. Historically, Broward County has had the highest acquisition rate in Florida, although the rate has fallen recently. In 1978, the acquisition rate in Broward County was approximately 138 per million population. By 1980, it had dropped to 119 per million persons. The state average for 1980 was between 105 and 110 per million. In September of 1979, 122 of the 305 persons receiving chronic hemodialysis treatments in Broward County came from Dade County and ten postal zones in the south end of Broward County. Petitioner's Exhibit No. 5. Residential growth in Broward County is occurring principally in the western part of the county. Petitioner proposes to build a ten-station hemodialysis facility at 4175 Southwest 84th Street, in Davie, Broward County, Florida. Dr. Herold, a nephrologist, would refer patients to petitioner's facility, if it is built, and if the South Broward Artificial Kidney Center fills up. Although not an expert in making such projections, Dr. Herold "would say ten [of his] patients, as a guesstimate, Deposition, p. 6, would be referred to petitioner's proposed facility annually. Dr. Zeig, another nephrologist, said three of his patients were in imminent need of dialysis, as were six patients of a former associate of his, a Dr. Levinson. Dr. Zeig testified that he would refer his patients, "upwards of eight to ten . . . in the coming year," Deposition, p. 10, to petitioner's facility, if built. In his deposition, Dr. Rose testified on April 20, 1981, that he could refer "in the range of five to maybe seven" patients to the proposed facility within "the next year." These projected patients are among the 122 persons forecast to develop end stage renal disease in Broward County in 1981 or the 125 expected to be afflicted in 1982. Respondent's Exhibit No. 3. Petitioner projects that the proposed facility could break even with eight patients. Medicare pays for about 95 percent of renal dialysis treatments, nationally. Three or four dialysis centers are within 20 minutes driving time of the site petitioner proposes. The proposed facility would be approximately six miles from Plantation Artificial Kidney Center (15 approved stations 80 percent utilized as of February 28, 1981), and only three or four miles from the Nephrology Associates' satellite facility in Pembroke Pines (four approved stations 44 percent utilized as of February 28, 1981). Located in Broward County south and east of petitioner's proposed facility are South Broward Artificial Kidney Center in Hollywood (30 approved stations 80 percent utilized as of February 28, 1981) and Nephrology Associates' main facility, which is also in Hollywood (10 approved stations 65 percent utilized as of February 28, 1981). Petitioner's Exhibit No. 5; Respondent's Exhibit No. 1. Petitioner's facility would be next north of the southernmost of what would be five hemodialysis centers in the western part of Broward County. Petitioner proposes to offer patients "free" transportation to and from the proposed facility. At present, only one hemodialysis facility in Broward County, Plantation Artificial Kidney Center, provides transportation for patients. There was testimony, however, that Broward County would provide transportation "through coordination with each of the dialysis facilities, if needed." Block Deposition, p. 19. Some patients requiring dialysis perform dialysis themselves at home. This practice is likely to increase significantly as a result of recent advances in continuous ambulatory peritoneal dialysis techniques. Projections that 35 persons in Broward County would elect this method of dialysis in 1981, 30 in 1982, and 40 in 1983 were not shown to be unrealistic, even though Broward County's home dialysis rates have historically been extremely low. On February 28, 1981, 13 of the 350 hemodialysis patients in Broward County underwent dialysis at home. In 1978, there was only one such patient in Broward County. Eighty-seven hemodialysis patients or approximately 19 percent of the total in Broward County died in 1980. Half of the four attempts to transplant kidneys in Broward County failed in 1980. As a practical matter: patients are likely to follow their physicians' advice about which dialysis center to go to. Dr. Herold testified that he choose[s] not to use, Deposition, p. 9, Nephrology Associates' satellite facility for some unspecified medical reason. Dr. Zeig expressed similar sentiments, but also testified that "all our patients were dialysized there, Deposition, p. 8, during the time that he himself had been associated with Nephrology Associates. Dr. Zeig also testified that he had a letter from Nephrology Associates' board of directors advising him he was unwelcome there. Dr. Rose testified that he would not refer patients to Nephrology Associates' satellite facility because of "strong feelings based on medical conditions that exist that I, too, choose not to discuss." Deposition, p. 5. There was hearsay testimony to the effect that Nephrology Associates reused chemical dialyzers, but absolutely no evidence tending to show that this was not good medical practice or that any formal complaint about Nephrology Associates had been filed anywhere on any ground. Nephrology Associates is fully certified for Medicare purposes. In preparing the foregoing findings of fact, the hearing officer had the benefit of respondent's memorandum, petitioner's memorandum of law, and petitioner's proposed recommended order. To the extent petitioner's proposed findings of fact have not been adopted in substance, they have been rejected as unsupported by or contrary to the evidence; or have been deemed irrelevant.
Recommendation It is, accordingly, RECOMMENDED: That respondent deny petitioner's application for certificate of need. DONE AND ENTERED this 7th day of July, 1981, in Tallahassee, Florida. ROBERT T. BENTON, II 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 7th day of July, 1981. COPIES FURNISHED: Guyte P. McCord, III, Esquire and Cynthia S. Tunnicliff, Esquire Post Office Box 82 Tallahassee, Florida 32302 Eric J. Haugdahl, Esquire 1317 Winewood Boulevard Tallahassee, Florida 32301 Richard Baron, Esquire Suite 500 444 Brickell Avenue Miami, Florida 33131 =================================================================
The Issue The issue in this case is whether Respondent, Charles R. Thompson, M.D., failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances as alleged in an Administrative Complaint entered November 3, 1993.
Findings Of Fact The Parties. Petitioner, the Agency for Health Care Administration (hereinafter referred to as the "Agency"), is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.165, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. (Stipulated Fact). Respondent, Charles R. Thompson, M.D., is, and has been at all times material hereto, a licensed physician in the State of Florida. Dr. Thompson was issued license number ME 0053590. Dr. Thompson's last known address is 8333 North Davis Highway, Pensacola, Florida 32514. (Stipulated Facts). Dr. Thompson specializes in internal medicine. Dr. Thompson is not, however, Board certified in internal medicine. (Stipulated Facts). At all times relevant to this proceeding, Dr. Thompson was a shareholder/employee of the Hodnette Medical Center Clinic, a/k/a The Medical Center Clinic, P.A. (hereinafter referred to as the Medical Center Clinic"), in Pensacola, Florida. Dr. Thompson has not been the subject of any disciplinary action against his license to practice medicine, other than the subject proceeding, and has had no medical malpractice claims asserted against him. Patient Number 1, K. M.. Patient Number 1, K. M., was a 27 year old female. (Stipulated Fact). K. M. had a history of severe insulin dependent diabetes mellitus, severe hypertension, blindness due to diabetic retinopathy, and chronic renal failure. K. M. had lost a toe due to gangrene. (Stipulated Facts). She suffered from fluctuating blood sugars, recurring problems with headaches, recurring problems with nausea and vomiting, recurring instances of non- compliance with physicians' orders, recurring episodes or phases of anemia and recurring periods during which she suffered from diabetic ketoacidosis. K. M. was also suspected of suffering from coronary artery disease, due to the severity and duration of her diabetes and the resulting peripheeral vascular disease. She was also suspected to suffer from diabetic gastroparesis, a condition that affects the function of the stomach and digestive tract. Dr. Thompson had become K. M.'s primary treating physician around October of 1989. She had been a patient at the Medical Center Clinic prior to becoming Dr. Thompson's patient. Emergency Room Visits Prior to September, 1990. During the year 1990, K. M. went to the Emergency Department of West Florida Regional Medical Center (hereinafter referred to as "West Florida Regional"), on eight different occasions prior to September 16, 1990. On some of the 1990 Emergency Department visits, K. M. presented with symptoms similar to those which she presented with at the time of the hospitalization which is the subject of this proceeding. The symptoms she presented with included headaches, nausea and vomiting, hypertension and manifestations of kidney dysfunction. Dr. Thompson was consulted on three of these occasions. K. M. was hospitalized from July 9, 1990 through July 19, 1990. She was under the care of Dr. Thompson during this hospitalization. K. M. was treated for insulin dependent mellitus, nausea and vomiting secondary to probable gastroparesis, hypertension, dehydratin and anemia. During K. M.'s July, 1990, hospitalization, she received IV fluids, blood pressure medications, and medication to treat nausea and vomiting and the effects of diabetic gastroparesis. She was discharged in stable condition on July 19, 1990. K. M.'s Hospitalization in September of 1990. On or about September 16, 1990, K. M. presented to the Emergency Department of West Florida Regional with complaints of headache, nausea and uncontrolled vomiting. K. M. was vomiting blood. (Stipulated Facts). Dr. Thompson, K. M.'s primary care physician, was consulted by the Emergency Department physician. Dr. Thompson examined K. M. and noted that she was dehydrated with no diarrhea or edema, had clear lungs and a regular heart rate and rhythm. K. M. had a blood pressure of 218/137. (Stipulated Facts). Dr. Thompson diagnosed K. M. with dehydration, nausea, probably due to chronic renal failure, and possible tear ("Mallory-Weis") to the esophagus due to severe vomiting. (Stipulated Facts). Dr. Thompson's assessment also included the following findings: (a) insulin-dependent diabetes mellitus; (b) hypertension; (c) chronic renal failure secondary to diabetic nephropathy; (d) migraine headaches; (e) mild diabetic ketoacidosis; (f) anemia; (g) poorly controlled blood sugars; and (h) tachycardia. At the time of her admission to West Florida Regional, K. M. was critically ill. A component of K. M.'s illness was her volume status. Dr. Thompson admitted K. M. to the Critical Care Unit (hereinafter referred to as the "CCU"), of West Florida Regional, administered Catapres intravenously to lower her blood pressure, and issued orders for intravenous rehydration and insulin therapy. (Stipulated Facts). Dr. Thompson also ordered Bicitra for K. M.'s acidosis. Dr. Thompson's full admitting orders are recited in Respondent's proposed finding of fact 8. The protocol for the CCU included orders for the contemporaneous recording of all intake and output of a patient receiving IV fluids, such as K. M. The protocol also included orders for the taking of vital signs, including pulse, respiration and blood pressure on a frequent and regular basis. The protocol orders were followed for K. M. K. M. was admitted to the CCU by Dr. Thompson because he believed she would receive more constant nursing supervision and attention than on the regular hospital floor. There was one nurse to every one or two patients on the CCU, a much higher nurse staffing ration than on the regular floor. On September 17, 1990, Dr. Thompson's physical examination of K. M. revealed that her nausea persisted with some vomiting. The bleeding, however, had decreased. Dr. Thompson's medical records reflect that K. M. refused an upper endoscopy to determine the cause of the bleeding. K. M. also declined Dr. Thompson's suggestion that she could benefit from a blood transfusion. Dr. Thompson also noted no edema. (Stipulated Facts). At 3:00 p.m., on September 17, 1990, Dr. Thompson ordered Demerol, 25 mg IM or IV every four hours PRN for pain. At 5:55 p.m. Dr. Thompson ordered 14 units of insulin, SQ stat. Dr. Thompson later ordered the following: Please begin clear liquids - ADA SMA-7, CBC in AM MG SO4 8 mg IV over 6 hrs (in N/S) Notify Dr. Wayne Miller of admit & location Stools for blood, X 3 Bicitra 15 cc po BID On September 18, 1990, Dr. Thompson examined K. M. Dr. Thompson found the following: Continues with nausea, vomiting. Some coffee-ground material. Afebrile, Vital Signs Stable. Exam--unchanged. Blood sugars fluctuating 35-400. Hematocrit down to 22.4 last p.m., 23 this a.m. Patient refuses transfusion and endoscopy. Will continue to monitor H & H and B.S. If Hematocrit continues to fall, will have to convince to have transfusion and endoscopy. Based upon Dr. Thompson's examination of K. M. on September 18, 1990, he ordered: (a) Hematocrit and hemoglobin be changed every 8 hours, instead of every 12 hours--call if Hematrocirt goes below 22; and (b) SMA-7, CBC in a.m. On or about September 19, 1990, Dr. Thompson examined K. M. and noted 1+ edema in the hands and feet. Edema is swelling and is an indication that a person is retaining excessive fluids. Dr. Thompson ordered 20 mg. of Lasix, a diuretic, and reduced K. M.'s fluid intake. According to Dr. Thompson's records he also found no S3 Gallup and that her lungs were clear. (Stipulated Facts). Dr. Thompson's observations of the results of his examination of September 19, 1990, were as follows: Patient confused yesterday and this a.m. Still with some dry heaves. Afebrile--vital signs stable. Lungs: clear CV: regular rate and rhythm without S3 gallop Abdomen: positive bowel signs, no increased organomegaly Extremities: 1+ edema feet and hands Intate/Output markedly positive Hematocrit 24.6 this a.m. Blood Sugars 100-250 Plan: Will transfer to floor--watch blood sugars and Hematocrit and Hemoglobin-- as long as stable Hematocrit and Hemoglobin, will try to hold on Endoscopy, but if nausea, gagging continue, will need to look at stomach. Give Lasix and decrease IV fluids. Check labs in a.m. Dr. Thompson ordered the following: Please transfer to floor, no monitor needed. Decrease Hematocrit and Hemoglobin checks to every 12 hours. SMA-18, CBC in a.m. Lasix 20 mg IV now. Decrease IV fluids to 100 CCs per hour [down from 150]. Decrease Zantac to 50 mg IV. After Dr. Thompson examined K. M. on September 19, 1990, he visited briefly with her parents. Dr. Thompson then checked out of the hospital and went home because he was ill. Pursuant to protocol, another physician was to cover for Dr. Thompson. On or about September 19, 1990, K. M. suffered cardiac arrest and revived. K. M. expired after multiple episodes of cardiac arrest. (Stipulated Facts). K. M. first sustained an acute myocardial infarction at approximately 3:00 p.m. This was the first time that K. M. first evidenced shortness of breath. Three separate Code 3 procedures were administered to K. M. During the Code 3 procedures she received additional fluids. The autopsy report on K. M. dated September 20, 1990 indicates that K. M. suffered from acture bilateral bronchopneumonia of the lower lobes with severe pulmonary edema and bilateral pleural effusions, severe artherosclerosis, and marked abdominal ascites. The cause of K. M.'s death was an acute myocardial infarction. (Stipulated Facts). To the extent that K. M. experienced a fluid overload, that condition did not cause the myocardial infarction she suffered. Fluid overload had nothing to do with the myocardial infarction. E. Monitoring K. M.'s Fluids. K. M.'s condition required that her fluids be monitored. K. M. was receiving rehydration therapy. She was also receiving medication to control her hypertension. These are opposing therapies and, therefore, more strict monitoring was required. While K. M. was dehydrated and needed fluids, the condition of her kidneys caused her to be less able to handle fluids. It is preferrable, however, that a patient such as K. M. experience some fluid overload as opposed to being dehydrated. Nonetheless, if a patient receives and retains excessive fluids it can be detrimental to the patient. For example, a patient that receives and retains excessive fluids may develop pulmonary edema. Dr. Thompson monitored K. M.'s rehydration progress through "gross methods". Dr. Thompson used physical examination, including listening to K. M.'s heart and lungs with a stethescope and physically and visually checking for swelling or the absence thereof. K. M.'s fluid intake and output was also recorded and reviewed by Dr. Thompson. K. M.'s intake and output of fluids was monitored and recorded on a continuing basis each day that she was hospitalized, consistent with protocols. Fluid intake was recorded by IV fluid, IV medication and oral consumption. Fluid output was recorded as urine, bowel movements and emesis. Measuring fluid intake and output is not completely accurate. Dr. Thompson monitored K. M.'s intake and output, he examined K. M. daily, he looked for pulmonary or cardiac signs of fluid overload, he reviewed nurses notes, graphic sheets recording pulse rate, respiration and blood pressure, and reviewed lab results. These items did not suggest that K. M. was experiencing fluid overload. Dr. Thompson was alert for any signs of edema. There was, in fact, no sign of edema until the morning of September 19, 1990, and Dr. Thompson took steps to alleviate what he concluded was mild edema. Until that time, K. had not evidenced any shortness of breath, which would have suggested pulmonary edema and a possible fluid overload. Dr. Thompson did not order the use of a Swan-Ganz catheter or a central venous line. These are both invasive devices designed to measure fluids. Dr. Thompson also did not order daily weighing of K. M. Weighing a patient can provide information about fluids levels by monitoring weight gain. Dr. Thompson also did not order daily x-rays of K. M.'s lungs to determine if she had fluid in her lungs. Dr. Thompson relied on listening to her lungs with a stethoscope. K. M. Experienced Excessive Fluids. K. M. experienced excessive fluids, or a "fluid overload", while under Dr. Thompson's care. The terms "fluid overload" refer to the condition of the body when excessive fluids are retained in the body. While hospitalized, K. M. received approximately 8,120 cc.'s of fluid in excess of what her intake and output measurements indicated she was excreting. On the second day of her hospitalization, K. M. received three times the amount of fluids she excreted. On the morning of September 19, 1990, a nurse caring for K. M. telephoned Dr. Thompson and expressed concern to Dr. Thompson over the amount of fluids K. M. was receiving. It was after this telephone call that Dr. Thompson noted K. M.'s edema and ordered a reduction in her fluids and that she be given Lasix, a diuretic. Although K. M. did not have any signs of fluid overload until the morning of September 19, 1990, the results of her autopsy indicate that she had begun suffering a fluid overload one or two days earlier. The autopsy also revealed that K. M. had bilateral pneumonia. This condition was not detected by Dr. Thompson during his clinical assessment of her. Did Dr. Thompson Fail to Adequately Monitor K. M.'s Fluid Level? The evidence failed to prove that there is a single, standard method of monitoring the fluid status of a patient such as K. M. The physicians called as witnesses by the Agency all agreed that Dr. Thompson failed to adequately monitor K. M.'s fluid levels. All three physicians disagreed, however, about the method of monitoring that should have been employed. The physicians called as witnesses by Dr. Thompson all agreed that Dr. Thompson's efforts to monitor K. M.'s fluid levels were adequate. The explanations provided by the Agency's witnesses of their opinions as to Dr. Thompson's treatment were inadequate to support a finding that the opinions as to Dr. Thompson's treatment provided by Dr. Thompson and his witnesses were inaccurate. The weight of the evidence failed to prove that Dr. Thompson deviated from the appropriate standard of care by failing to adequately monitor K. M.'s condition. The weight of the evidence failed to prove that Dr. Thompson failed to practice medicine with an acceptable level of care, skill, and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order dismissing all charges in the Administrative Complaint entered against Charles R. Thompson, M.D. DONE and ENTERED this 1st day of July, 1996, in Tallahassee Florida. LARRY J. SARTIN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of July, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-6437 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Agency's Proposed Findings of Fact Accepted in 2. Accepted in 3. Accepted in 6-7. Accepted in 14. Accepted din 14-15 and 18. See 16 and 19. Hereby accepted. Accepted in 8. 9-10 Accepted in 18. Accepted in 32. Hereby accepted. Accepted in 34-36. Accepted in 35. 15-16 Not supported by the weight of the evidence. 17 Accepted in 33. 18-19 Accepted in 32. Hereby accepted. Not supported by the weight of the evidence. See 26. Accepted in 27. Hereby accepted. See 20. 26-27 Not supported by the weight of the evidence. 28 Accepted in 40. 29-30 Accepted in 41. The last sentence of proposed finding of fact 30 is not supported by the weight of the evidence. 31 See 42. 32-33 Accepted in 25. 34 See 25 and 42-43. Accepted in 25 and 27. See 27 and hereby accepted. Accepted in 29. Not supported by the weight of the evidence. Accepted in 30 and 43. Accepted in 32. Accepted in 26. 42-43 Accepted in 43. 44-50 Not supported by the weight of the evidence. Dr. Thompson's Proposed Findings of Fact Accepted in 2-4 and hereby accepted. Accepted in 9. Accepted in 7-8. Accepted in 10-11 and hereby accepted. Accepted in 12-13 and hereby accepted. Accepted in 14-16 and 18. Accepted in 17. Accepted in 19 and hereby accepted. Accepted in 21 and hereby accepted. 10-11 Accepted in 21. Accepted in 22. Accepted in 23. Accepted in 24. Accepted in 26 and hereby accepted. Accepted in 27. Although generally correct, this charge was dismissed by Petitioner. Accepted in 35 and hereby accepted. Accepted in 28 and hereby accepted. Accepted in 29 and hereby accepted. Accepted in 30. Statement of the issues. Paragraph 22(a) was dismissed by Petitioner. Hereby accepted. Accepted in 35. See 34-36. Restatement of previously proposed findings. Accepted in 37-39. See 44-49. These proposed findings constitute an accurate summary of testimony. See 45-49. These proposed findings constitute an accurate summary of testimony. 29-30 These proposed findings constitute an accurate summary of testimony. See 45-49. These proposed findings constitute an accurate summary of testimony. These proposed findings constitute an accurate summary of testimony. 33-34 These proposed findings are generally correct but are irrelevant. 35-36 These proposed findings constitute an accurate summary of testimony. See 45-49. These proposed findings constitute an accurate summary of testimony. These proposed findings constitute an accurate summary of testimony and argument. These proposed findings are a repeat of previous proposed findings. Hereby accepted. Accepted in 36. These proposed findings are a repeat of previous proposed findings. Hereby accepted. 44 See 45-49. COPIES FURNISHED: Britt Thomas, Esquire Agency for Health Care Administration Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 James M. Wilson, Esquire 307 Palafox Street Pensacola, Florida 32501 Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Douglass M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman, Esquire 2727 Mahan Drive Tallahassee, Florida 32309
