Findings Of Fact Respondent Ahmed Elkadi, who holds a license to practice medicine in Florida, No. 0031490, was one of two surgeons (among some half dozen physicians) on the staff of Weems Memorial Hospital in Apalachicola, Florida, in August of 1988. Whether the physicians on staff who were not surgeons had other specialties and, if so, what they were, the proof did not show. A duly licensed 29-bed general hospital, Petitioner's Exhibit No. 7, Weems Memorial had, "on a . . . stat basis," (Fitzgerald Deposition at 13), despite its small size, "24-hour respiratory therapy capability, 24-hour laboratory coverage, [and] 24-hour radiology coverage," (Fitzgerald Deposition at 5), which did not, however, include computed tomographic scanning or magnetic resonance imaging technology, both available only at facilities some 60 or 70 miles away. Continuous cardiac monitoring was available in house. Id. at 16. Weems Memorial had a physician in house 24 hours a day and a registered nurse on duty 24 hours a day, along with "at least one LPN," (Fitzgerald Deposition at 6), and two nurse's aides. Id. On average, Weems Memorial only had five or six inpatients at any one time during 1988. Staff off premises but on call were required to report within 30 minutes of being summoned. Fitzgerald Deposition at 13. On August 22, 1988, Dr. Elkadi admitted A. L. as a patient, in preparation for gastric bypass surgery the following day. A 29-year-old woman, A. L. (who worked as a nurse at the hospital) stood 5 feet 1.5 inches tall and weighed 303 pounds, when admitted. A chest x-ray taken before she was admitted uncovered no abnormalities other than obesity. Because she "was in excess of twice her standard weight for height," (MacGregor Deposition, p.7) and had "blood cholesterol elevation and [elevated levels of] blood triglycerides," Id., p.8, and because of her age, A. L. was an appropriate candidate for gastric bypass surgery, Corwin Deposition. She signed a form consenting to the operation. Roux-en-Y Dr. Elkadi performed the surgery, a "gastric bypass with Roux-en-y gastrojejunostomy," Petitioner, Exhibit No. 2, p. 7, on August 23, 1988. A. L., who was anxious about the impending operation, received Valium as well as anesthesia before the procedure began. While A. L. lay on her back anesthetized, he cut open her abdomen and partitioned her stomach with staples, thus reducing the capacity of her stomach to receive food; and joined the small, newly segregated, upper portion of her stomach directly to the small intestine. In a contemporaneous operative note, Dr. Elkadi described the procedure: . . . . The TA 90 stapler was used twice to proximal gastric from the proximal apply a double staple line across the stomach to separate a small proximal pouch with a capacity of about 30 cc remaining stomach cavity. A loop of in side using inner for was jejunal completed. 14 the the jejunum was pulled up through an opening the transverse mesocolon and anastomosed to side to the proximal gastric pouch a running suture of 3-0 chromic for the layer and interrupted 3-0 silk sutures the outer layer. A naso-gastric tube passed into the distal limb of the loop before the anastomosis was The gastrojejunostomy measured about 12- mm in diameter. The proximal limb of jejunal loop was then disconnected just proximal to the gastrojejunostomy using GIA stapler, and the cut end was anastomosed to the distal limb about 60 cm distal to the also gastrojejunostomy. The GIA stapler was used for the entero-enterostomy supported by a running 3-0 silk suture for the serosal transverse loop layer. The edges of the opening of the mesocolon were sutured to the jejunal . The using a fascia, a of using interrupted 3-0 silk sutures. . . abdominal wall was closed in layers running suture of #1 Dexon for the running suture of #3-0 Dexon for the subcutaneous layer, and a running suture #3-0 Nylon for the skin. . . . Petitioner's Exhibit No. 2. As reported and as is customary, Dr. Elkadi severed the small intestine just above the newly fashioned connection to the "small proximal gastric pouch." Because gastric juices continue to leave the distal stomach and travel through the disconnected intestinal segment, the procedure was not complete until this segment of the jejunum was rejoined to the small intestine lower down. In manipulating the jejunum to accomplish the reconnection, it was necessary to cut and tie off various blood vessels, including tributaries of the mesenteric vein. Dr. MacGregor, one of petitioner's expert witnesses, testified that "[t]he record indicates that [the surgery] was done appropriately." T.15. On deposition, petitioner's counsel asked and Dr. MacGregor answered: Q. It seems to be a normal surgery? A. Right. Q. Except for the amount of time? A. Correct MacGregor deposition 15. The operation took four hours. The other surgeon petitioner called as an expert testified that "probably four hours would be a reasonable time." Corwin Deposition at 12. Petitioner produced no witness who testified that respondent's work in the operating room failed to meet standards of any kind. Sequelae In the wake of operations of this kind, "mortality can be as high as 2.7 to 2.9 per cent at training centers who have documented teams of specialists and post op care specialists." T.15. Complications "tend to be in two major groups . . . pulmonary embolism and infections." Id. The "most important complication of gastric bypass surgery is perforation or leakage," (MacGregor Deposition at 16) which leads to infection. In many hospitals, nursing administration routinely assigns a formal nursing plan for postoperative patients, after consulting with the surgeon. MacGregor Deposition at 15. But practices vary (Corwin Deposition at 13) and the omission of a formal nursing plan altogether "in and of itself . . . is not unusual," (Fitzgerald Deposition at 12) at least in smaller hospitals. No formal, written nursing or contingency plan was drawn up for A. L. Dr. Elkadi did not originally direct care for A. L. "beyond what [staff] would normally do [for] any postoperative surgical patient." Fitzgerald Deposition at 11. A. L. left the operating room at ten before two on the afternoon of August 23, 1988. An hour and 40 minutes later, her pulse rate was 84 and her respiration was 28. Petitioner's Exhibit NO. 2. At ten o'clock that night, her pulse was 112 and her respiration was 36; and, at or about the same time, her temperature was approximately 97.2o F. A half hour later, with Dr. Elkadi present, A. L. was standing by her bedside and taking a few steps. The next morning she sat up, first on the side of her bed, then in a chair. At half past one on August 24, 1988, she walked to the nursing station, which she "tolerated well." But, after she returned to her bed, she complained of "surgical pain." At six o'clock that evening she walked a short distance in the hall, returned to her room, sat in a chair and, after she had gone back to bed, again complained of "surgical pain." A chest x-ray taken the day after the operation revealed "[s]mall areas of linear atelectasis . . . in the lung bases," Petitioner's Exhibit No. 2, p. 43, which a radiologist attributed to A. L.'s not having taken a full breath. He found that a "full inspiration was not taken during filming," Id., and that the atelectasis was "probably for this reason." Id. On the evening of August 24, 1988, the nursing notes reported "slight drainage of dark green fluid" from the nasogastric tube. Earlier that day, bloody drainage ("scant") was reported for what may have been the first and only time. The last entry in the nurse's notes characterized the drainage as dark brown; "scant amt greenish drainage," Petitioner's Exhibit No. 2, was reported as late as four o'clock on August 26, 1988. Also at four o'clock on the afternoon of August 26, 1988, the nurse's notes reported, "Bowel sounds [were] audible in all 4 quadrants." Petitioner's Exhibit NO. 2. At seven o'clock that evening, according to the same source, A. L. "had small tan colored lo[ose] stool." Id. A blood specimen drawn at nine o'clock on the morning of August 26, 1988, yielded a "WBC" test result of "19.9." Id. at an unnumbered page. The white blood cell count had "c[o]me down to 11,000 on the day of [A. L.'s] admission." Petitioner's Exhibit No. 2, p. 7. On the morning of August 25, 1988, another walk in the hall ended with A. L.'s sitting in a chair. The nurses' notes reported that she was "[t]olerating activity well." Petitioner's Exhibit No. 2. At eleven o'clock that night, "belching incessantly," she complained of back and stomach pain, and a nurse helped her take a walk. She was still up (sitting in a chair) at midnight, when a second walk resulted in "much relief in stomach." Pain and belching persisted, nevertheless, and Dr. Elkadi was called, arriving at ten before one o'clock in the early morning of August 26, 1988. After seeing A. L., respondent ordered an enema and a dose of Vistaril. At quarter past one, she was pushing on her stomach to relieve gas pains. The nurses' notes reported that she was "extremely anxious," and Dr. Elkadi prescribed five milligrams of Valium. She continued to belch, and Dr. Elkadi was notified of her distress and anxiety at three o'clock in the morning. After she received another five milligrams of Valium (presumably at Dr. Elkadi's behest), she fell asleep. At 5:20 that morning, she was given a third five milligram dose of Valium, and at seven o'clock three milligrams more. In each instance, it was administered intravenously by "slow push." Awake by seven, when she complained of abdominal pain, she was given two milligrams of Levodromoran, after walking to and from the nursing station. When the respiratory therapist saw her at nine o'clock, she was sitting in a chair, again complaining of abdominal pain. But an hour later, when she went to the shower, she said she had less gas pain. That afternoon, she rested in bed, sat in a chair, and walked in the hall. The day after the operation, A. L.'s temperature had risen to 100.5o F., and her pulse had reached 128. When her pulse declined on the following day, August 25, 1988, her temperature remained elevated. On August 26, however, her temperature dropped to normal and her pulse leveled off at the low to mid 90s. On August 23, 1988, the day of the surgery, and again on each of the two following days, Dr. Elkadi ordered extra intravenous fluids. On more than one occasion, the nurse's notes reported that intravenous solution was infusing with difficulty, or words to that effect. While a 1500-milliliter per day discrepancy between fluid intake and urine output is to be expected, the discrepancy averaged some 3500 milliliters per day in A. L.'s case, following her surgery. After surgery, she was given morphine in five-milligram doses, intravenously, as needed. The day after the operation, A. L. also received Levodromoran for pain. On August 25, 1988, although she again received both pain-killing medications, she required less morphine. On August 26, 1988, however, in response to complaints of pain, the amounts both of morphine and of Levodromoran she received increased over the previous day's totals. Dr. Elkadi also prescribed Valium and Vistaril; and A. L. received a total of 100 milligrams of the latter, on August 26, 1988, in multiple doses. In addition, Dr. Elkadi prescribed and A. L. received Nubain, an analgesic that, according to Dr. MacGregor, "is a narcotic antagonist." Petitioner's Exhibit No. 1 to MacGregor Deposition. It is therefore possible that Nubain offset the increased dosages of narcotics in whole or in part. The Last Day A. L. awoke at half past six on the morning of August 27, 1988, complained of pain, and received an injection of Nubain. Only 30 minutes later, she complained of "pain between shoulders," but she received no more pain medication, according to the nurse's notes, until five after two that afternoon, when she was given an injection of five milligrams of Valium. (Twelve hours earlier, she had received ten milligrams of Valium.) At seven o'clock on the morning of August 27, 1988, the nurse's notes again reported "good bowel sounds heard in all quad." Id. Early that afternoon, after an enema, according to the nurse's notes, "pt had good results of flatus & sm amt of lg stool." Id. At four o'clock, she "passed some flatus." Id. At quarter of eight that morning, and again at nine, A. L. used a spirometer. Dr. Solman saw her at eight o'clock. She complained of shortness of breath at nine. A chest x-ray taken August 27, 1988, showed "areas of atelectasis in each lung base, somewhat more pronounced on the right side." Id. at 44. At three o'clock that afternoon, she was hyperventilating. When Dr. Loutfi saw her at half past three, her lungs were clear, and the X-ray taken earlier in the day had evidently not yet been seen by a radiologist. At half past four, a nurse gave A. L. ten milligrams of Valium "for relaxation/rest," Petitioner's Exhibit No. 2, and, fifteen minutes later, a "bag to breathe in," which A. L. used for about five minutes. The nurse initialled A. L.'s chart next to a physician's order that concluded: "Valium 10 mg. IV slowly." Petitioner's Exhibit No. 2. Asked on deposition who ordered the Valium, Dr. Corwin testified: And then it says. I can't read what it says. record to Loutfi in far as NAR? I don't know. DR. ELKADI: Dr. Ludwig [sic]. BY DR. ELKADI: Q. All right. In patients having - - MRS. SMALL: I would object for the the questioner testifying. Corwin Deposition at 42. Perhaps Dr. ordered the Valium. The order was not, any event, given by the respondent, as the evidence shows. At quarter past five, the nurse "encouraged [A. L.] to slow/deep breathe." Id. Ten minutes later she found A. L., whom she had last seen sitting on the side of her bed, sprawled across it. Cyanotic around the mouth, she was not breathing. After Drs. Loutfi and Elkadi tried in vain to resuscitate A. L., respondent pronounced her dead, at 6:30 p.m. on August 27, 1988. Cause of Death Unclear Each of the four physicians who testified at hearing or on deposition assigned a different reason for A. L.'s death. Dr. Elkadi reported the following in a discharge summary: The postoperative course during the first 4 occasional the blood of be Patient the The was patient was days was uneventful except for episodes of anxiety, usually related to incisional pain or discomfort caused by NG-tube, and which always responded to sedation or analgesis medication. The oxygenation was measured during several these anxiety episodes and was found to satisfactory with 02 saturation level of 95-97% using the finger tip oxymeter. was walking outside the room already on first postoperative day. By the fourth postoperative day the Foley catheter was removed and she had 2 bowel movements. incision was healing well, and the chest clear to auscultation. On 8/27/88, about 5:20 p.m., the suddenly arrested, and cardiopulmonary resuscitation was carried out. There heart to over an The of considerable airway resistance, and the was in asystole which failed to respond large doses of cardiac drugs. After hour of intensive resuscitative efforts, patient was pronounced dead at 6:30 p.m. course of events was strongly suggestive massive pulmonary embolism. Petitioner's Exhibit No. 2. After the autopsy revealed that the only blood clots in the lungs had formed post mortem, Dr. Elkadi refined his hypothesis, and posited a fat embolus or emboli in the lungs, which, he surmised, degraded into free fatty acids before the autopsy took place, perhaps before death occurred. He testified that free fatty acids produce serotonin, which causes bronchospasms, and he cited resistance the airway offered during the unsuccessful attempt to resuscitate A. L. Ventilation and oxygenation were virtually impossible, even though the endotracheal tube was already in place. Although Dr. Mahoney, the pathologist who performed the autopsy, found a fatty liver, he ruled out a pulmonary fat embolism because he saw no evidence of infection or trauma to the liver (which might have dislodged fat) and because examination of lung and brain tissue (a single section of each) revealed no fat globules. "No intravascular lipid vacuoles were identified in the lung." Petitioner's Exhibit No. 2. On the other hand, "[o]ccasional perivascular lipid vacuoles were seen . . . in the brain section . . . ," Id., indicating fat cells must have passed through the lungs at some point. The autopsy report made no mention of any mechanical blockage or of distension of any part of the gastrointestinal track. Nor was there evidence of alimentary leakage. All sutures held. "Inspection [during the autopsy] of the surgical sites where the surgeon had done anastomotic, reanastomosis of stomach and bowel . . . [showed] these sites were intact and grossly appeared viable." T. 9. Dr. Mahoney listed as a major finding in the autopsy report "[i]schemic enteritis with focal necrosis of the proximal jejunal segment at the entero-enterostomy junction of the Roux-en-y procedure; mesenteric vein thrombosis." Petitioner's Exhibit No. 2. But at hearing he testified, consistently with reported results of microscopic examination, that "major findings at the autopsy . . . [included] a segment of intestine, the jejunal segment, which had undergone a hemorrhagic necrosis." T. 8. Ischemic changes occur when blood supply is insufficient, while hemorrhagic changes are the result of insufficient ability to remove blood. Blood clots blocked veins serving the necrotic tissue. At hearing, Dr. Mahoney concluded "that the most probable cause [of A. L.'s death] was this dead bowel segment essentially causing sepsis." T. 13. Microorganisms penetrating the transmural necrosis caused localized infection outside the bowel or peritonitis, he testified, which led to infection in the blood stream. Septic toxins circulating in the blood caused cardiovascular failure, he theorized. These conclusions rest on autopsy findings of serositis and "approximately 1 liter of cloudy brown fluid with fibrin strands," (Petitioner's Exhibit No. 2) in the abdominal cavity. But Dr. Mahoney did not find "certain types of cells" (T.94) usually found two and a half to three days after peritonitis sets in. In fact, the autopsy findings "are not unusual findings after abdominal surgery without any complication." T.130. Dr. Corwin, one of two surgeons testifying as experts for petitioner, testified that "the autopsy report . . . [contained] essentially no indication of peritonitis." Corwin Deposition at 46. In a report petitioner put in evidence, Dr. Corwin had earlier written that "there really is no evidence of peritonitis." Dr. Corwin wrote, on June 25, 1990, after examining A. L.'s records, "In my opinion the heavy dose of intravenous Valium within the hour before the patient's sudden cardiac arrest almost certainly caused apnea, respiratory shutdown and subsequent to this, the patient suffered a cardiac arrest from which she could not be resuscitated." Petitioner's Exhibit No. 3. Dr. Mahoney testified that the final administration of Valium "may have actually contributed to a respiratory arrest" (T.15) and so to A. L.'s death. A. L. received her last dose of valium 45 minutes before she was last seen alive and 55 minutes before she was found dead. Dr. Corwin conceded that he had ordered Valium for patients in circumstances comparable to A. L.'s over a period of some 17 years, but always, he said, in situations where the patient would be watched, until the effects of the drug wore off. When administered intravenously, Valium has its maximum effect within five minutes. As far as the evidence showed, A. L. did not have an adverse effect to any earlier dose of Valium. For moderate anxiety, the Physicians' Desk Reference (1987 ed.) recommends dosages of "2 mg to 5 mg, I. M. or I. V. Repeat in 3 to 4 hours, if necessary." For severe anxiety, the same reference recommends dosages of "5 mg to 10 mg, I. M. or I. V. Repeat in 3 to 4 hours, if necessary." "Valium is indicated for the management of . . . short-term relief of the symptoms of anxiety." Respondent's Exhibit No. 2. Contraindications are "known hypersensitivity" and glaucoma. Dr. MacGregor, the other surgeon whose opinion petitioner relied on, testified that the "fundamental cause [of A. L.'s death was hypovolemic shock . . . [shock brought on by l]ow blood volume." MacGregor Deposition at 30. When asked, Dr. MacGregor agreed that Valium "may have contributed," id. at 29, to A. L.'s death. But his principal contention was that the focal necrosis created an ileus or physiological obstruction, which caused distension of the stomach and upper gastrointestinal tract which in turn led to a loss of fluid into the lining of the stomach and bowel and ultimately to hypovolemic shock. Recordkeeping Petitioner presented evidence from the same two surgeons on the question whether respondent had adequate medical records while treating A. L. In a letter attached to Dr. Corwin's deposition as an exhibit, he wrote: Did the subject prepare and keep written medical records justifying the course of treatment of the patient, including history, examination and test results? The answer to this question is yes. Deposition of Corwin, Petitioner's Exhibit No. 3. Dr. MacGregor testified that respondent's operative note was "inadequate in terms of . . . [d]etails of sutures and the techniques that were used . . . the instruments used . . . not the number of sutures but the type of sutures and the number of layers." Deposition of MacGregor at 12. But on cross-examination, Dr. MacGregor conceded that "similar operative notes [are] found in many other surgeons' records." Deposition of MacGregor at 35. The hospital records contain a separate, presumably complete list of the surgical instruments Dr. Elkadi used. Although Dr. Elkadi ordered arterial blood gas evaluations, and blood tests specifically to determine oxygen saturation, results of these tests are not in the hospital records, insofar as the hearing officer could discover. Dr. MacGregor testified the results were not in the copy of the records he was furnished. He testified: I think a blood gas was obtained but it's not two helpful normal in the records; and oxygen saturation on occasions. . . . [T]hey would be quite because they might well indicate fairly levels in a patient who has a rapid respiratory rate . . . Deposition of MacGregor at 24. Dr. MacGregor testified that he "would have thought that [it] would have been standard hospital procedure for whoever obtained those, to have recorded them in the record." Deposition of MacGregor at 25.
Recommendation It is, accordingly, RECOMMENDED: That petitioner dismiss the administrative complaint against respondent. DONE and ENTERED this 25th day of January, 1991, in Tallahassee, Florida. Administrative Hearings 1550 the Administrative Hearings 1991. ROBERT T. BENTON, II Hearing Officer Division of The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399- (904) 488-9675 Filed with the Clerk of Division of this 28th day of January, APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact Nos. 1 through 7, 12, 14, 15, 16, 18, 20, 21, 22 and 28 have been adopted, in substance, insofar as material. With respect to petitioner's proposed findings of fact Nos. 8 and 9, see paragraphs 11 through 28 of the findings of fact. With respect to petitioner's proposed findings fact No. 10, the record showed dosages, before the final dose, of five, five, five, three, ten and five milligrams. With respect to petitioner's proposed finding of fact No. 11, some tests were done; others were not. Petitioner's proposed findings of fact Nos. 13, 19, 23, 24, and 26 pertain to subordinate matters. With respect to petitioner's proposed findings of fact Nos. 17 and 25, the cause of death was not clear. Petitioner's proposed findings of fact Nos. 27 and 29 were not proven. Petitioner's proposed findings of fact No. 31 is immaterial. Respondent's proposed findings of fact Nos. 1, 2 and 3 in Part 1 and 3 in Part 2, have been accepted, in substance, insofar as material. With respect to respondent's proposed finding of fact No. 4 in Part 1 and No. 10 in Part 3, these matters are not material to the allegations of the administrative complaint. With respect to respondent's proposed finding of fact No. 5 in Part 1 and Part 2, the cause of death is unclear. With respect to respondent's proposed findings of fact Nos. 1, 2 and 8 in Part 3, see findings of fact Nos. 11 through 28. With respect to respondent's proposed finding of fact No. 4 in Part 3, the autopsy report does not reflect this but he so testified at hearing. Respondent's proposed findings of fact Nos. 5, 6, 7 and 9 pertain to subordinate matters. COPIES FURNISHED: Wellington H. Meffert, II, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Ahmed Elkadi, M.D. 236 S. Tyndall Parkway Panama City, FL 32404 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issue is whether respondent's license as a physician should be disciplined for the reasons cited in the administrative complaint filed on December 21, 1992.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background Respondent, Kenneth Aung-Din, is a licensed medical doctor having been issued license number ME 0051923 by petitioner, Agency for Health Care Administration, Board of Medicine (Board). He is board certified in emergency medicine having received his certification in 1994. When the events herein occurred, respondent was an emergency room physician at Memorial Medical Center (MMC) in Jacksonville, Florida. On the evening of February 21, 1991, V. P., a thirty-five year old female who was then eight months pregnant, presented herself to the MMC emergency room complaining of lower abdominal discomfort, difficulty urinating, and a five-hour history of nausea and vomiting. After being examined and treated by respondent, and diagnosed as having a urinary tract infection, the patient was released the same evening. Less than an hour later, however, the patient went into labor and delivered a new born. On December 21, 1992, the Board issued a two-count administrative complaint charging that, while treating V. P., respondent failed to practice medicine with that level of care, skill, and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions and circumstances in that he "failed to obtain fetal heart tones, determine fetal position, and ausculatate for fetal heart tones with a doppler that was available to him in the ER when he examined (the) patient, who was a high risk near term obstetrical patient." The complaint further alleges that respondent failed to keep written medical records justifying the course of treatment of V. P., "including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations." Respondent denied all material allegations and requested this hearing to contest these charges. Did respondent deviate from the standard of care? On presentment to the emergency room nurse around 8:53 p.m. on February 21, 1991, V. P. complained of generalized abdominal pain and pressure since around 3:30 p.m. that day, with nausea and two episodes of vomiting. She also complained that she was unable to urinate since approximately 2:30 p.m. An additional complaint was allegedly made by the patient, but it is not a part of the nurse's notes and thus is hearsay in nature. The patient further disclosed that this was her second pregnancy. After recording in her notes the patient's complaints, the nurse, on her own volition, conducted a nitrozine test which was negative. It later came to light that the test was improperly conducted by the nurse, but respondent was never told this fact. Respondent first observed the patient around 9:08 p.m. and recalled that she "was obviously in discomfort." Based on V. P.'s complaints, respondent initially suspected that she might be in preterm labor. After obtaining a patient history, respondent palpitated V. P.'s abdomen for any pain, tenderness, abnormalities or contractions. Although V. P. was eight months pregnant, she was nontender and exhibited no signs of active labor. The patient also denied that she was having contractions. Based on V. P.'s primary complaint of urinary retention, respondent asked the nurse to insert a Foley catheter in V. P.'s bladder. Before the nurse did so, V. P. was able to urinate on her own accord. Even so, respondent ordered a catheter inserted around 9:30 p.m. to empty any residual in the bladder. This procedure yielded approximately 200cc. of urine which was used for a urinalysis test. By now, having urinated at least once, and having her bladder emptied, V. P.'s pain and discomfort had gone away, and she appeared to be "totally comfortable and with no complaints." After seeing the results of the nitrozine test around 9:55 p.m., respondent conducted a pelvic examination. Still considering the possibility of preterm labor, respondent inserted a vaginal speculum into the patient to see if there was any bleeding or fluid. Neither was present, and a manual examination of the patient revealed that the opening to her cervix was thick and closed. A patient in preterm labor would generally present signs of bleeding or fluid, and the cervix would have begun to open and "thin out." Given these findings, and the fact that V. P. was exhibiting no signs of labor or discomfort, it was reasonable for respondent to conclude that V. P. was not in preterm labor. The results of the urinalysis were reviewed by respondent around twenty minutes before the patient's discharge. By that time, she had voluntarily urinated at least three times since first arriving at the emergency room. The test results revealed 1+ protein, trace ketones, and 0-2 white and red blood cells. Also, they indicated that a sterile (uncontaminated) specimen had been taken, and that trace bacteria were present. Because trace bacteria, if not treated, can lead to "a very significant" urinary tract infection, and V. P. had previously experienced abdominal "pressure" and an inability to urinate, both signs of an infection, respondent prescribed Ampicillin, an antibiotic, on the assumption V. P. had a urinary tract infection. This diagnosis is not unusual for pregnant women, and even petitioner's expert agreed that V. P. had presented some of the "classical signs" of a urinary tract infection. After having observed the patient for almost two hours, during which time V. P. exhibited no objective clinical signs of active labor, respondent discharged the patient around 10:50 p.m. In doing so, respondent relied not only on the above observations, but also upon the results of his pelvic and abdominal evaluations, the urinalysis test results, and the fact that all of V. P.'s complaints (pain, nausea and vomiting) had been resolved. It was also reasonable to conclude that had the patient been in preterm labor, her symptoms would have progressed, rather than abated, during the two hours she was in the emergency room. At the time of discharge, respondent gave V. P. instructions to make a follow-up visit that week with her primary physician at University Medical Center (UMC), and if her condition did not improve during the interim, to return to MCC or call the "emergency department right away for further assistance." She was also given a prescription for an antibiotic for the urinary tract infection. Just prior to leaving the hospital, V. P. urinated one last time and allegedly told the nurse that she had started "spotting." Even if V. P. actually reported this critical fact, the nurse failed to disclose this to respondent, and he cannot be faulted for the nurse's omission. Had respondent known, or even suspected, that she had just begun bleeding, he would have sent her upstairs to the obstetrical wing for further observation. The complaint levels a number of criticisms at respondent's conduct which, if true, indicate that he failed to meet the appropriate standard of care. In addressing these criticisms, it should be noted that petitioner's own expert agreed that, at best, this was "a difficult case," and one that all emergency room physicians "hate to see." The complaint characterizes V. P. as a "high risk near term obstetrical patient." The use of the term "high risk" is based principally on the fact that an ultrasound conducted at UMC on February 19, 1991, revealed that the fetus was in a breech position. But respondent was never told this fact, and even petitioner's expert conceded that without this information, it was reasonable for respondent to consider V. P. as a normal risk pregnancy. The complaint first alleges that respondent "failed to assess the status of the fetus by neglecting to auscultate for fetal heart tones with a doppler that was available to him in the Emergency Department." A doppler is a device used to listen for fetal heart tones and, while not as effective as other monitoring devices, is nonetheless useful in detecting fetal distress or preterm labor. Here, respondent did not assess the status of V. P.'s fetus because her pain and discomfort had disappeared after her urinary tension was resolved, and she no longer exhibited any signs, clinical or otherwise, of preterm labor. At the same time, while doppler machines were available in emergency rooms, including MMC, during the early 1990's when this incident occurred, it was not prevailing protocol for emergency room physicians to automatically conduct fetus monitoring for what they perceived to be normal risk pregnancies. While the standard for emergency room physicians has subsequently changed, and fetal heart tones are now routinely monitored on all pregnant women twenty weeks and above, respondent did not deviate from the prevailing standard of care in February 1991 by failing to use a doppler. The complaint next alleges that a prudent physician "would have telephoned (V. P.'s) treating physician from UMC, or the obstetrician- gynecologist on call in order to properly assess (her) condition." As to calling V. P.'s treating physician, however, the more persuasive evidence shows that it would have been imprudent to attempt to contact V. P.'s primary treating physician because she had been treated by an unknown resident at another hospital, and at that hour of the night the chance of speaking with that resident was highly improbable. Then, too, since her complaints had been resolved, there was no need to contact another physician. As to respondent's failure to obtain a specialist consultation, the more persuasive evidence shows that the diagnosis of urinary tract infection was reasonable under the circumstances, and after the patient exhibited no signs of distress for at least an hour and a half, her discharge was appropriate. While it is true, as petitioner suggests, that the initial complaints by V. P. of pressure, nausea, vomiting and abdominal pains can be signs of preterm labor, these complaints were resolved after the catheter was inserted, and there were no corroborating indications of labor. Then, too, based on the information at hand, respondent reasonably concluded that V. P. was a normal risk pregnancy. Finally, later inquiry disclosed that during her first pregnancy, V. P. was in labor for only fifteen minutes, a remarkably short period of time. Respondent was not aware of this fact at the time of treatment. As it turned out, V. P. experienced another remarkably short period of labor on the evening of February 21, 1991. In summary, the more persuasive evidence supports a finding that, while treating V. P. in February 1991, respondent practiced medicine with that level of care, skill and treatment which was recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. C. Adequacy of Medical Records The complaint generally alleges that respondent failed to keep written medical records justifying the course of treatment of the patient. In the history section of his notes for patient V. P., which have been made a part of this record, respondent made the following recordations: 2110 - 35-year old white female, eight months pregnant; complaining of unable to urinate; dysuria; feels like pressure; denies vaginal bleeding; no contractions; Under the physical examination portion of his notes, respondent reported as follows: white female, well developed, awake, alert, times 3. Abdomen, pregnant uterus equals 8 months; nontender. Pelvic - zero blood; oz thick and closed. Late entry - 2/26/91, Nitrozine Test performed, which was negative. Finally, under his diagnostic impressions and discharge instructions, respondent wrote as follows: UTI (urinary tract infection) Ampicillin 250 mg, q.i.d., for 7 times. Tylenol if needed. Follow up, UMC this week. Return if any problems. In responding to the charge that his notes were inadequate or incomplete, respondent agreed that the diagnostic impressions section would have been more accurate and complete if he had written "urinary retention- resolved/UTI" rather than "UTI" alone. This is because urinary retention was a secondary diagnosis which was resolved during the patient's visit. In this respect, the records are not adequate. In addition, because the records fail to note that V. P.'s symptoms of abdominal pain and pressure were resolved, they lack completeness. In all other respects, they are found to be adequate.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order finding respondent guilty of violating Section 458.331(1)(m), Florida Statutes, as described above, and that he be given a reprimand. Count I should be dismissed. DONE AND ENTERED this 1st day of October, 1996, in Tallahassee, Florida. DONALD R. ALEXANDER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 1st day of October, 1996. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Kevin W. Crews, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 W. Jerry Foster, Esquire 1342 Timberlane Road, Suite 101-A Tallahassee, Florida 32312-1775 Jerome W. Hoffman, Esquire Agency for Health Care Administration Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403
Findings Of Fact MCH was constructed circa 1973 as an acute care hospital and before 1980 had 126 medical-surgical beds authorized including eight intensive care beds. MCH is a for-profit hospital owned by Hospital Corporation of America. It is financially able to fund the proposed addition. In 1980 it received a certificate of need (CON) to add 64 medical-surgical beds for a total bed capacity of 190 medical-surgical beds. These beds came on line in January 1982. MCH here proposes to add a 54-bed unit for oncology patients; to add six operating rooms to use primarily for eye, ear, nose and throat surgical procedures on an outpatient basis; and a new eight-bed surgical intensive care unit located on the first floor adjacent to the existing surgery department. Currently, the hospital has two oncologists on staff who use a 16-bed unit dedicated to the treatment of cancer. Space exists for the additional operating room so the net result is an application for an additional 62 beds. The application also included expansion of general stores and maintenance and the addition of a parking structure, which were granted, leaving only the issue of need for the 62 additional beds requested at a cost of $7 million. When constructed MCH had an eight-bed ICU primarily for coronary care patients located on the second floor of the hospital in the opposite wing from the surgery department on the first floor. It has added a four-bed ICU on the fourth floor by converting two semiprivate medical-surgical rooms. The ratio of ICU beds to total beds in 1973 was 8:126 which is nearly identical to the current ratio of 12:190. The evidence was unrebutted that the ICU at MCH is usually full, that on occasion patients have to wait in the emergency room until a less ill patient can be moved from a bed in ICU, and that the more ICU beds are available the more they will be used. This use was attributed to the doctors desiring their patients to be in an ICU and to testimony that current surgical procedures are more sophisticated than formerly and a greater need exists today for a surgery patient to go to an ICU than existed 15 years ago. In its application for a CON (Exhibit 18) MCH's estimated charge for a medical-surgical bed is $100-150 per day and its estimated charge for ICU beds and SICU beds is $350 per day. The primary service area for MCH is Marion County. Petitioner submitted evidence that nearly 20 percent of the cancer patients diagnosed in Marion County in 1981 came from the surrounding counties of Citrus, Lake, Sumter, and Levy. Accordingly, MCH contends that its primary service area for oncology patients should include these counties. Evidence was also submitted that MCH has been certified by medical associations as an approved cancer treatment hospital; that oncology service is a service generally provided in regional hospitals which provide Level III medical treatment; and, therefore, MCH should be considered on a different scale than Level II services. No evidence was presented that any health systems plan ever considered MCH as a regional cancer hospital or established any bed need for cancer patients at MCH. The evidence was also unrebutted that cancer patients at MCH are primarily treated by chemotherapy; that the drugs used in the treatment are extremely toxic, some have a short life span after being mixed and must be used almost immediately; that having a mini-pharmacy in the cancer ward is highly desirable; that special training of nurses is required to safely administer these drugs to patients; that patients develop nausea, ulcers in the mouth and throat, and present special feeding problems, and because of these special feeding problems it is advantageous to have some facilities in the cancer ward to prepare food at odd hours for patients; that cancer is a "personal" disease, patients desire more privacy, and should have private rooms; that an area away from the patient's room where the patient can visit with his or her family and the family can consult with the doctor in some privacy is desirable; that some newer drugs require hospitalization of the patient for treatment with these drugs, but the hospital stay is shorter and the drugs may be used over longer periods of time; and that the patient needs the security that comes from developing a feeling of trust by the patient of the nurses and doctors who are administering to his needs. MCH has no radiation treatment facilities in the hospital. However, the hospital staff has access to a Linear Accelerator which is located in a private physician's office on MCH's campus. Several witnesses testified to the need for additional beds for cancer patients at MCH; that patients have had to wait several days for a vacant bed; some oncology patients have had to be placed in other wards at MCH; and that special treatment and special training for nurses are required for oncology patients. Marion Regional Medical Center (MRMC) is a nonprofit hospital owned by the Marion County Hospital District, a public body established by statutes with taxing powers in Marion County. MRMC is currently expanding its facilities by 80 beds to the authorized 314-bed hospital pursuant to a CON approved in 1981. The $23 million for that project was financed by revenue bonds issued by Marion County Hospital District. Preliminary bids indicate the original project will be under the estimated cost resulting in a $2-3 million savings. If the additional beds here requested are approved and the construction associated therewith can be accomplished concurrently with the present construction, a saving of nearly $1 million can be obtained. MRMC is the only full service hospital in Marion County and provides medical, surgical, obstetrical, pediatric, psychiatric, intensive care, coronary care, and neurological/neurosurgical services. It has the third most active Emergency Room in the state and receives approximately 45 percent of its admissions through this service. MRMC's proposed project calls for the construction of a sixth floor on the hospital, construction of 66 inpatient beds, and the conversion of a 20-bed pediatric unit for use as a labor and delivery suite, a net gain of 46 beds. As initially proposed, this would provide for eight additional pediatric beds, four pediatric intensive care beds, and 34 medical-surgical beds to be used as a pulmonary medicine unit. Before the hearing the request for additional pediatric beds was withdrawn, leaving a request for 34 additional hospital beds and four pediatric intensive care beds, a total of 38 medical-surgical beds, at a cost of $2.8 million. It was stipulated that both MCH and MRMC provide an acceptable quality of care and operate efficiently. The application satisfied the criteria in Section 381.494(6)(c) with the possible exception of need, and need is the only issue in dispute in these proceedings. Both applicants submitted evidence that they accept all patients regardless of their ability to pay; however, MCH is a private for-profit hospital whose bad debt and charity care amounts to two percent of its gross revenues. MRMC's patient load is four percent indigent and bad debts, and charity care amounts to 12 percent of its gross revenues. Exhibit 18 shows MCH patient utilization to be 61 percent Medicare and one percent Medicaid, and MRMC patient utilization to be 51 percent Medicare and five percent Medicaid, in 1981. There is currently "applicable district plan" or "annual implementation" as provided for in Section 381.494(6)(c)1, Florida Statutes (1982). The implementation of this statute has been stayed by rule challenges. The North Central Florida Health Planning Council, Inc. (NCFHPC), was the Health Systems Agency (HSA) for what was formerly known as Health Service Region II which included only Marion County as a district sub-area. Prior to the July 1, 1982, amendment of Florida's CON law, the HSA reviewed applications and made recommendations with written findings of fact to DHRS. The 1982 CON law eliminated HSA, accordingly the NCFHPC no longer exists. The former HSA recommended approval of the applications of both MCH and MRMC; however, the staff of the HSA recommended disapproval of both applications. For the determination of need in these proceedings, a planning horizon of five years is acceptable and was used by all parties. Thus, the need for the requested CON is assessed for the year 1988. At this time the population of Marion County is forecast to be 165,880. The percentage of persons 65 and older in Marion County is increasing in proportion to the remainder of Marion County's population, and this increase will continue through 1988. This "aging" of the population is occurring throughout the United States as people live longer and demographics change with differing birth rates at differing periods. No evidence was submitted that the percentage of people over 65 is greater in Marion County than in other parts of Florida. MCH has 190 authorized medical-surgical beds and MRMC has 244 authorized medical-surgical beds, for a total of 434 such beds authorized in Marion County in two hospitals across the street from each other in Ocala, Florida. With the 1982 amendment to the CON statute the HSA in Marion County ceased to exist and has been replaced by a local health council. Rule challenges have stayed the promulgation of a comprehensive state health plan and the only Health Systems Plan in being for Marion County is the revised 1983 Health Systems Plan (HSP). This plan was approved by the HSA for Marion County in June of 1982 and contains goals, objectives and standards for planning for the health services required in Marion County. Standard 1-1 provides the need for medical-surgical beds within each Level II planning area (Marion County) should be based on the actual 1980 medical-surgical bed need per 1,000 population in this area. Standard 2-1 provides no additional beds should be added to a community's total bed supply until the occupancy rate of medical- surgical beds in the community exceeds 85 percent if more than 200 such beds are available in the community. The generally accepted standard for occupancy rate above which more beds may be needed is 80 percent. However, where beds are concentrated in one area, which is the case in Marion County where 434 medical- surgical beds are authorized, 85 percent occupancy leaves a reasonable surplus of beds to cover most emergencies or unusual situations that would cause the bed availability to be exceeded. The need for medical-surgical beds per 1,000 population (use rate) in Marion County in 1980 was 2.41. The HSP has a goal of 3.5 beds per 1,000 population and an objective of 4.0 beds per 1,000 population by 1987 in Region II. Applying the 1980 use rate to the 1988 forecast population of Marion County results in a need for 400 medical-surgical beds. The Health Systems Plan update for Marion County defines medical- surgical beds as all hospital beds which are not reserved solely for the use of pediatric, obstetrics, or psychiatric patients. At the time the revised Health Systems Plan for Marion County was promulgated, the two hospitals, MRMC and MCH, had been authorized an additional 80 and 65 beds, respectively, and these beds were being placed in service. By prescribing a use rate for 1980 as the standard to be used in considering applications for additional medical-surgical beds in 1983 and for a year or two thereafter, it would be reasonable to conclude the HSA expected the use rate for the years 1981 and 1982 to be influenced by the addition of the recently authorized 144 beds and to not accurately reflect a reliable use rate for planning purposes. MRMC and MCH presented expert witnesses who, by using different modalities, containing different assumptions, arrived at a need for additional beds in Marion County in 1988 ranging from 97 to 200. Most of these modalities used an occupancy rate of 3.5 beds per 1,000 population and 80 percent utilization of beds. All assume increasing usage of medical-surgical beds by the increasing and aging population. In their application MRMC and MCH planned to finance these projects with rate increases of 11 percent per year (to keep even with inflation) and a continuing increase in the number of patients handled at these higher rates. While inflation may again be up to 11 percent or higher, it is generally accepted today that the current inflation rate is five percent or less. More than 50 percent of both MRMC and MCH patients are presently covered by Medicare, which pays 80 percent of the charges generated by these patients. To assume that this situation will not only continue in the face of current federal deficits, but grow to cover the increased use of these facilities predicted in the assumptions used to show increased bed need for 1988, is not necessarily a valid assumption. Evidence was presented that the number of doctors in Marion County has doubled in the last five years. The ratio of doctors to the population of Marion County for 1977-78 and 1982-83 was not presented nor was the percent increase in the number of doctors in the United States over the past five years. Without some basis for comparison, the fact that the number of doctors in a particular community doubled over a five-year period has no relevancy.
The Issue Kindred Hospitals East, LLC ("Kindred") and Select Specialty Hospital-Palm Beach, Inc. ("Select-Palm Beach"), filed applications for Certificates of Need ("CONs") with the Agency for Health Care Administration ("AHCA" or the "Agency") seeking approval for the establishment of long-term care hospitals ("LTCHs") in Palm Beach County, AHCA District 9. Select-Palm Beach's application, CON No. 9661, seeks approval for the establishment of a 60-bed freestanding LTCH in "east central" Palm Beach County about 20 miles south of Kindred's planned location. Kindred's application, CON No. 9662, seeks approval for the establishment of a 70-bed LTCH in the "north central" portion of the county. The ultimate issue in this case is whether either or both applications should be approved by the Agency.
Findings Of Fact Long Term Care Hospitals Of the four classes of facilities licensed as hospitals by the Agency, "Class I or general hospitals," includes: General acute care hospitals with an average length of stay of 25 days or less for all beds; Long term care hospitals, which meet the provisions of subsection 59A-3.065(27), F.A.C.; and, Rural hospitals designated under Section 395, Part III, F.S. Fla. Admin. Code R. 59A-3.252(1)(a). This proceeding concerns CON applications for the second of Florida's Class I or general hospitals: LTCHs. A critically ill patient may be admitted and treated in a general acute care hospital, but, if the patient cannot be stabilized or discharged to a lower level of care on the continuum of care within a relatively short time, the patient may be discharged to an LTCH. An LTCH patient is almost always "critically catastrophically ill or ha[s] been." (Tr. 23). Typically, an LTCH patient is medically unstable, requires extensive nursing care with physician oversight, and often requires extensive technological support. The LTCH patient usually fits into one or more of four categories. One category is patients in need of pulmonary/respiratory services. Usually ventilator dependent, these types of LTCH patients have other needs as well that requires "complex comprehensive ventilator weaning in addition to meeting ... other needs." (Tr. 26). A second category is patients in need of wound care whose wound is life-threatening. Frequently compromised by inadequate nutrition, these types of LTCH patients are often diabetic. There are a number of typical factors that may account for the seriousness of the wound patient's condition. The job of the staff at the LTCH in such a case is to attend to the wound and all the other medical problems of the patient that have extended the time required for care of the wound. A third category is patients with some sort of neuro-trauma. These patients may have had a stroke and are often elderly; if younger, they may be victims of a car accident or some other serious trauma. They typically have multiple body systems that require medical treatment, broken bones and a closed head injury for example, that have made them "very sick and complex." (Tr. 27). The fourth category is referred to by the broad nomenclature of "medically complex" although it is a subset of the population of LTCH patients all of whom are medically complex. The condition of the patients in this fourth category involves two or more body systems. The patients usually present at the LTCH with "renal failure ... [and] with another medical condition ... that requires a ventilator ..." Id. In short, LTCHs provide extended medical and rehabilitative care to patients with multiple, chronic, and/or clinically complex acute medical conditions that usually require care for a relatively extended period of time. To meet the definition of an LTCH a facility must have an average length of inpatient stay ("ALOS") greater than 25 days for all hospital beds. See Fla. Admin. Code R. 59A-3.065(34). The staffs at general acute care hospitals and LTCHs have different orientations. With a staff oriented toward a patient population with a much shorter ALOS, the general acute care hospital setting may not be appropriate for a patient who qualifies for LTCH services. The staff at a general acute care hospital frequently judges success by a patient getting well in a relatively short time. It is often difficult for general acute care hospital staff to sustain the interest and effort necessary to serve the LTCH patient well precisely because of the staff's expectation that the patient will improve is not met in a timely fashion. As time goes by, that expectation continues to be frustrated, a discouragement to staff. The LTCH is unlike other specialized health care settings. The complex, medical, nursing, and therapeutic requirements necessary to serve the LTCH patient may be beyond the capability of the traditional comprehensive medical rehabilitation ("CMR") hospital, nursing home, skilled nursing facility ("SNF"), or, the skilled nursing unit ("SNU"). CMR units and hospitals are rarely, if ever, appropriate for the LTCH patient. Almost invariably, LTCH patients are not able to tolerate the minimum three (3) hours of therapy per day associated with CMR. The primary focus of LTCHs, moreover, is to provide continued acute medical treatment to the patient that may not yet be stable, with the ultimate goal of getting the patient on the road to recovery. In comparison, the CMR hospital treats medically stable patients consistent with its primary focus of restoring functional capabilities, a more advanced step in the continuum of care. Services provided in LTCHs are distinct from those provided in SNFs or SNUs. The latter are not oriented generally to patients who need daily physician visits or the intense nursing services or observations needed by an LTCH patient. Most nursing and clinical personnel in SNFs and SNUs are not experienced with the unique psychosocial needs of long-term acute care patients and their families. An LTCH is distinguished within the healthcare continuum by the high level of care the patient requires, the interdisciplinary treatment model it follows, and the duration of the patient's hospitalization. Within the continuum of care, LTCHs occupy a niche between traditional acute care hospitals that provide initial hospitalization care on a short-term basis and post-acute care facilities such as nursing homes, SNFs, SNUs, and comprehensive medical rehabilitation facilities. Medicare has long recognized LTCHs as a distinct level of care within the health care continuum. The federal government's prospective payment system ("PPS") now treats the LTCH level of service as distinct with its "own DRG system and ... [its] own case rate reimbursement." (Tr. 108). Under the LTCH PPS, each patient is assigned an LTC- DRG (different than the DRG under the general hospital DRG system) with a corresponding payment rate that is weighted based on the patient diagnosis and acuity. The Parties The Agency is the state agency responsible for administering the CON Program and licensing LTCHs and other hospital facilities pursuant to the authority of Health Facility and Services Development Act, Sections 408.031-408.045, Florida Statutes. Select-Palm Beach is the applicant for a free-standing 60-bed LTCH in "east Central Palm Beach County," Select Ex. 1, stamped page 12, near JFK Medical Center in AHCA District 9. Its application, CON No. 9661, was denied by the Agency. Select-Palm Beach is a wholly owned subsidiary of Select Medical Corporation, which provides long term acute care services at 83 LTCHs in 24 states, four of which are freestanding hospitals. The other 79 are each "hospitals-in-a- hospital" ("HIH" or "LTCH HIH"). Kindred is the applicant for a 70-bed LTCH to be located in the north central portion of Palm Beach County in AHCA District 9. Its application, CON No. 9662, was denied by the Agency. Kindred is a wholly owned subsidiary of Kindred Healthcare, Inc. ("Kindred Healthcare"). Kindred Healthcare operates 73 LTCHs, 59 of which are freestanding, according to the testimony of Mr. Novak. See Tr. 56-57. Kindred Healthcare has been operating LTCHs since 1985 and has operated them in Florida for more than 15 years. At the time of the submission of Kindred's application, Kindred Healthcare's six LTCHs in Florida were Kindred-North Florida, a 60-bed LTCH in Pinellas County, AHCA District 5; Kindred-Central Tampa, with 102 beds, and Kindred-Bay Area- Tampa, with 73 beds, both in Hillsborough County, in AHCA District 6; Kindred-Ft. Lauderdale with 64 beds and Kindred- Hollywood with 124 beds, both in Broward County, ACHA District 10; and Kindred-Coral Gables, with 53 beds, in Dade County, AHCA District 11. The Applications and AHCA's Review The applications were submitted in the first application cycle of 2003. Select-Palm Beach's application is CON No. 9661; Kindred's is CON No. 9662. Select-Palm Beach estimates its total project costs to be $12,856,139. Select-Palm Beach has not yet acquired the site for its proposed LTCH, but did include in its application a map showing three priority site locations, with its preferred site, designated "Site 1," located near JFK Medical Center. At $12,937,419, Kindred's estimate of its project cost is slightly more than Select-Palm Beach's. The exact site of Kindred's proposed LTCH had not been determined at the time of hearing. Kindred's preference, however, is to locate in the West Palm Beach area in the general vicinity of St. Mary's Hospital, in the northern portion of Palm Beach County along the I-95 corridor. This is approximately 15 to 20 miles north of Select's preferred location for its LTCH. There is no LTCH in the five-county service area that comprises District 9: Indian River, Okeechobee, St. Lucie, Martin, and Palm Beach Counties. There are two LTCHs in adjacent District 10 (to the south). They have a total of 188 beds and an average occupancy of 80 percent. The Agency views LTCH care as a district-wide service primarily for Medicare patients. At the time of the filing of the applications, the population in District 9 was over 1.6 million, including about 400,000 in the age cohort 65 and over. About 70 percent of the District 9 population lives in Palm Beach County. More than 70 percent of the District's general acute care hospitals are located in that county. Kindred's preferred location for its LTCH is approximately 40 to 50 miles from the closest District 10 LTCH; Select-Palm Beach is approximately 25 to 35 miles from the closest District 10 LTCH. The locations of Select Palm-Beach's and Kindred's proposed LTCHs are complementary. The SAAR Following its review of the two applications, AHCA issued its State Agency Action Report ("SAAR"). Section G., of the report, entitled "RECOMMENDATION," states: "Deny Con #9661 and CON #9662." Agency Ex. 2, p. 43. On June 11, 2003, the report was signed by Karen Rivera, Health Services and Facilities Consultant Supervisor Certificate of Need, and Mr. Gregg as the Chief of the Bureau of Health Facility Regulation. It contained a section entitled "Authorization for Agency Action" that states, "[a]uthorized representatives of the Agency for Health Care Administration adopted the recommendations contained herein and released the State Agency Action Report." Agency Ex. 2, p. 44. The adoption of the recommendations is the functional equivalent of preliminary denial of the applications. In Section F. of the SAAR under the heading of "Need," (Agency Ex. 2, p. 40), the Agency explained its primary bases for denial; it concluded that the applicants had not shown need for an LTCH in AHCA District 9. The discussions for the two, although not precisely identical, are quite similar: Select Specialty Hospital-Palm Beach, Inc.(CON #9661): The applicant's two methodological approaches to demonstrate need are not supported by any specific discharge studies or other data, including DRG admission criteria from area hospitals regarding potential need. The applicant also failed to provide any supporting documentation from area physicians or other providers regarding potential referrals. It was further not demonstrated that patients that qualify for LTCH services are not currently being served or that an access problem exists for residents in District 9. Kindred Hospitals East, L.L.C. (CON #9662): The various methodological approaches presented are not supported by any specific DRG admission criteria from area hospitals suggesting potential need. The applicant provided numerous letters of support for the project from area hospitals, physicians and case managers. However, the number of potential referrals of patients needing LTCH services was not quantified. It was further not demonstrated that patients that qualify for LTCH services are not currently being served or that an access problem exists for residents in District 9. Id. At hearing, the Agency's witness professed no disagreement with the SAAR and continued to maintain the same bases contained in the SAAR for the denials of the two applications The SAAR took no issue with either applicant's ability to provide quality care. It concluded that funding for each applicant was likely to be available and that each project appeared to be financially feasible once operating. The SAAR further stated that there were no major architectural concerns regarding Kindred's proposed facility design, but noted reservations regarding the need for further study and revision of Select Palm-Beach's proposed surgery/procedure wing, as well as cost uncertainties for Select Palm Beach because of such potential revisions. By the time of final hearing, however, the parties had stipulated to the reasonableness of each applicant's proposed costs and methods of construction. The parties stipulated to the satisfaction of a number of the statutory CON criteria by the two applicants. The parties agreed that the applications complied with the content and review process requirements of sections 408.037 and 409.039, Florida Statutes, with one exception. Select reserved the issue of the lack of a Year 2 of Schedule 6, (Staffing) in Kindred's application. The form of Schedule 6 provided by AHCA to Kindred (unlike other schedules of the application) does not clearly indicate that a second year of staffing data must be provided. The remainder of the criteria stipulated and the positions of the parties as articulated in testimony at hearing and in the proposed orders that were submitted leave need as the sole issue of consequence with one exception: whether Kindred has demonstrated that its project is financially feasible in the long term. Kindred's Long Term Financial Feasibility Select-Palm Beach contends that Kindred's project is not financially feasible in the long term for two reasons. They relate to Kindred's application and are stated in Select Palm Beach's proposed order: Kindred understated property taxes[;] Kindred completely fails to include in its expenses on Schedule 8, patient medical assistance trust fund (PMATF) taxes [citation omitted]. Proposed Recommended Order of Select-Palm Beach, Inc., p. 32, Finding of Fact 97. Raised after the proceeding began at DOAH by Select- Palm Beach, these two issues were not considered by AHCA when it conducted its review of Kindred's application because the issues were not apparent from the face of the application. AHCA's Review of Kindred's Application Kindred emerged from a Chapter 11 bankruptcy proceedings on April 20, 2001, under a plan of reorganization. With respect to the events that led to the bankruptcy proceeding and the need to review prior financial statements, AHCA made the following finding in the SAAR: Under the plan [of reorganization], the applicant [Kindred] adopted the fresh start accounting provision of SOP 90-7. Under fresh start accounting, a new reporting entity is created and the recorded amounts of assets and liabilities are adjusted to reflect their estimated fair values. Accordingly, the prior period financial statements are not comparable to the current period statements and will not be considered in this analysis. Agency Ex. 2, p. 30. The financial statements provided by Kindred as part of its application show that Kindred Healthcare, Kindred's parent, is a financially strong company. The information contained in Kindred's CON application filed in 2003 included Kindred Healthcare's financial statements from the preceding calendar year. Kindred Healthcare's Consolidated Statement of Operations for the year ended December 31, 2002, showed "Income from Operations" to be more than $33 million, and net cash provided by operating activities (cash flow) of over $248 million for the period. Its Consolidated Balance Sheet as of December 31, 2002, showed cash and cash equivalents of over $244 million and total assets of over $1.6 billion. In light of the information contained in Kindred's CON application, the SAAR concluded with regard to short term financial feasibility: Based on the audited financial statements of the applicant, cash on hand and cash flows, if they continue at the current level, would be sufficient to fund this project as proposed. Funding for all capital projects, with the support of its parent, is likely to be available as needed. Agency Ex. 2, p. 30 (emphasis supplied). The SAAR recognized that Kindred projected a "year two operating loss for the hospital of $287,215." Agency Ex. 2, p. Nonetheless, the SAAR concludes on the issue of financial feasibility, "[w]ith continued operational support from the parent company, this project [Kindred's] is considered financially feasible." Id. The Agency did not have the information, however, at the time it reviewed Kindred's application that Kindred understated property taxes and omitted the Public Medicaid Trust Fund and Medical Assistance Trust Fund ("PMATF") "provider tax" of 1.5 percent that would be imposed on Kindred's anticipated revenues of $11,635,919 as contended by Select-Palm Beach. Consistent with Select Palm-Beach's general contentions about property taxes and PMATF taxes, "Kindred acknowledges that it likely understated taxes to be incurred in the operation of its facility." Kindred's Proposed Recommended Order, paragraph 50, p. 19. The parties agree, moreover, that the omitted PMATF tax is reasonably projected to be $175,000. They do not agree, however, as to the impact of the PMATF tax on year two operating loss. The difference between the two (approximately $43,000) is attributable to a corporate income tax benefit deduction claimed by Kindred so that the combination of the application's projected loss, the omitted PMATF tax, and the deduction yields a year two operating loss of approximately $419,000. Without taking into consideration the income tax benefit, Select-Palm Beach contends that adding in the PMATF tax produces a loss of $462,000. Kindred and Select-Palm Beach also disagree over the projection of property taxes by approximately $50,000. Kindred projects that the property taxes in year two of operation will be approximately $225,000 instead of the $49,400 listed in the application. Select-Palm Beach projects that they will be $50,000 higher at approximately $275,000. Whether Kindred's or Select-Palm Beach's figures are right, Kindred makes two points. First, if year two revenues and expenses, adjusted for underestimated and omitted taxes, are examined on a quarterly basis, the fourth quarter of year two has a better bottom line than the earlier quarters. Not only will the fourth quarter bottom line be better, but, using Kindred's figures, the fourth quarter of year two of operations is profitable. Second, and most importantly given the Agency's willingness to credit Kindred with financial support from its parent, Kindred's application included in its application an interest figure of $1.2 million for year one of operation and $1.03 million for year two. Kindred claims in its proposed recommended order that "[i]n reality ... this project will incur no interest expense as Kindred intends to fund the project out of cash on hand, or operating capital, and would not have to borrow money to construct the project." Id., at paragraph 54, p. 20. Through the testimony of John Grant, Director of Planning and Development for Kindred's parent, Kindred Healthcare, Kindred indicated at hearing that its parent might, indeed, fund the project: A ... Kindred [Healthcare] would likely fund this project out of operating capital. Like I said, in the first nine months of this year Kindred had operating cash flow of approximately $180 million. So it's not as if we would have to actually borrow money to complete a project like this. Q And what was the interest expense that you had budgeted in Year Two for this facility? A $1,032,000. Q ... so is it your statement then that this facility would not owe any interest back to the parent company? A That's correct. Tr. 221-222 (emphasis supplied). If the "financing interest" expense is excluded from Kindred's statement of projected expenses in Schedule 8 of the CON application, using Kindred's revised projections, the project shows a profit of approximately $612,0002 for the second year of operation. If Select-Palm Beach's figures and bottom line loss excludes the "finances interest" expense, the elimination of the expense yields of profit for year two of operations in excess of $500,000. If the support of Kindred's parent is considered as the Agency has signaled its willingness to do and provided that the project is, in fact, funded by Kindred Healthcare rather than financed through some other means that would cause Kindred to incur interest expense, Kindred's project is financially feasible in the long term. With the exception of the issue regarding Kindred's long term financial feasibility, as stated above, taken together, the stipulation and agreements of the parties, the Agency's preliminary review contained in the SAAR, and the evidence at hearing, all distill the issues in this case to one overarching issue left to be resolved by this Recommended Order: need for long term care hospital beds in District 9. Need for the Proposals From AHCA's perspective prior to the hearing, the only issue in dispute with respect to the two applications is need. This point was made clear by Mr. Gregg's testimony at hearing in answer to a question posed by counsel for Select-Palm Beach: Q. ... Assuming there was sufficient need for 130 beds in the district is there any reason why both applicants shouldn't be approved in this case, assuming that need? A. No. (Tr. 398). Both applicants contend that the application each submitted is superior to the other. Neither, however, at this point in the proceeding, has any objection to approval of the other application provided its own application is approved. Consistent with its position that both applications may be approved, Select-Palm Beach presented testimony through its health care planner Patricia Greenberg3 that there was need in District 9 for both applicants' projects. Her testimony, moreover, rehabilitated the single Kindred methodology of three that yielded numeric need less than the 130 beds proposed by both applications: Q ... you do believe that there is a need for both in the district. A I believe there's a need for two facilities in the district. Q It could support two facilities? A Oh, absolutely. Q And the disagreement primarily relates to the conservative approach of Kindred in terms of not factoring in out-migration and the narrowing the DRG categories? A Correct. ... Kindred actually had three models. Two of them support both facilities, but it's the GMLOS model that I typically rely on, and it didn't on the surface support both facilities. That's why I reconciled the two, and I believe that's the difference, is just the 50 DRGs and not including the out-migration. That would boost their need above the 130, and two facilities would give people alternatives, it would foster competition, and it would really improve access in that market. Tr. 150-51. Need for the applications, therefore, is the paramount issue in this case. Since both applicants are qualified to operate an LTCH in Florida, if need is proven for the 130 beds, then with the exception of Kindred's long term financial feasibility, all parties agree that there is no further issue: both applications should be granted. No Agency Numeric Need Methodology The Agency has not established a numeric need methodology for LTCH services. Consequently, it does not publish a fixed-need pool for LTCHs. Nor does the Agency have "any policy upon which to determine need for the proposed beds or service." See Fla. Admin. Code R. 59C-1.008(2)(e)1. Florida Administrative Code Rule 59C-1.008(2), which governs "Fixed Need Pools" (the "Fixed Need Pools Rule") states that if "no agency policy exist" with regard to a needs assessment methodology: [T]he applicant will be responsible for demonstrating need through a needs assessment methodology which must include, at a minimum, consideration of the following topics, except where they are inconsistent with the applicable statutory or rule criteria: Population demographics and dynamics; Availability, utilization and quality of like services in the district, subdistrict or both; Medical treatment trends; and Market conditions. Fla. Admin. Code R. 59C-1.008(2)(e)2. The Fixed Need Pools Rule goes on to elaborate in subparagraph (e)3 that "[t]he existence of unmet need will not be based solely on the absence of a health service, health care facility, or beds in the district, subdistrict, region or proposed service area." Population, Demographics and Dynamics The first of the four topics to be addressed when an applicant is responsible for demonstrating need through a needs assessment methodology is "population, demographics and dynamics." The Agency has not defined service areas for LTCHs. Nonetheless, from a health planning perspective, it views LTCH services as being provided district-wide primarily for Medicare patients. Consistent with the Agency's view, Select-Palm Beach identified the entire district, that is, all of AHCA District 9, as its service area. It identified Palm Beach County, one of the five counties in AHCA District 9, as its primary service area. In identifying the service area for Select-Palm Beach, Ms. Greenberg drew data from various sources: population estimates for Palm Beach County and surrounding areas; the number of acute care hospital beds in the area; the number of LTCH beds in the area; the types of patients treated at acute care hospitals; and the lengths of stay of the patients treated at those hospitals. AHCA District 9 has more elderly than any other district in the State, and Palm Beach County has more than any other county except for Dade. Palm Beach County residents comprise 71% of the District 9 population. It is reasonably projected that the elderly population (the "65 and over" age cohort) in Palm Beach County is projected to grow at the rate of 8 percent by 2008. The "65 and over" age cohort is significant because the members of that cohort are most likely to utilize hospital services, including LTCH services. Its members are most likely to suffer complications from illness and surgical procedures and more likely to have co-morbidity conditions that require long- term acute care. Persons over 65 years of age comprise approximately 80 percent of the patient population of LTCH facilities. Both Select-Palm Beach and Kindred project that approximately 80 percent of their admissions will come from Medicare patients. Since 90 percent of admissions to an LTCH come from acute care facilities, most of the patient days expected at Select-Palm Beach's proposed LTCH will originate from residents in its primary service area, Palm Beach County. When looking at the migration pattern for patients at acute care facilities within Palm Beach County, the majority (90 percent) come from Palm Beach County residents. Thus, Select- Palm Beach's projected primary service area is reasonable. Just as Select-Palm Beach, Kindred proposes to serve the entire District. Kindred proposes that its facility be based in Palm Beach County because of the percentage of the district's population in the county as well as because more than 70% of the district's general acute care hospitals are in the county. Its selection of the District as its service area, consistent with the Agency's view, is reasonable. Currently there are no LTCHs in District 9. Availability, Utilization and Quality of Like Services The second topic is "availability, utilization and quality of like services." There are no "like" services available to District residents in the District. Select-Palm Beach and Kindred, therefore, contend that they meet the criteria of the second topic. There are like services in other AHCA Districts. For example, AHCA District 10 has at total of 188 beds at two Kindred facilities in Fort Lauderdale and Hollywood. The Agency, however, did not present evidence of their quality, that they were available or to what extent they are utilized by the residents of AHCA District 9. Medical Treatment Trends The third topic is medical treatment trends. Caring for patients with chronic and long term care needs is becoming increasingly more important as the population ages and as medical technology continues to emerge that prolongs life expectancies. Through treatment provided the medically complex and critically ill with state of the art mechanical ventilators, metabolic analyzers, and breathing monitors, LTCHs meet needs beyond the capability of the typical general acute care hospitals. In this way, LTCHs fill a niche in the continuum of care that addresses the needs of a small but growing patient population. Treatment for these patients in an LTCH, who otherwise would be cared for without adequate reimbursement to the general acute care hospital or moved to an alternative setting with staff and services inadequate to meet their needs, is a medical trend. Market Conditions The fourth topic to be addressed by the applicant is market conditions. The federal government's development of a distinctive prospective payment system for LTCHs (LTC-DRG), has created a market condition favorable to LTCHs. General acute care hospitals face substantial losses for the medically complex patient who uses far greater resources than expected on the basis of individual diagnoses. Medicare covers between 80 and 85 percent of LTCH patients. The remaining patients are covered by private insurance, managed care and Medicaid. LTCH programs allow for shorter lengths of stay in a general acute care facility, reduces re-admissions and provide more discharges to home. These benefits are increasingly recognized. Numeric Need Analysis Kindred presented a set of needs assessment methodologies that yielded numeric need for the beds applied for by Kindred. Select-Palm Beach did the same. Unlike Kindred, however, all of the needs assessment methodologies presented by Select-Palm Beach demonstrated numeric need in excess of the 130 beds proposed by both applications. Select-Palm Beach's methodologies, overall, are superior to Kindred's. Select-Palm Beach used two sets of needs assessment methodologies and sensitivity testing of one of the sets that confirmed the methodology's reasonableness. The two sets or needs assessment methodologies are: (1) a use rate methodology and (2) length of stay methodologies. The use rate methodology yielded projected bed need for Palm Beach County alone in excess of the 130 beds proposed by the two applicants. For the year "7/05 - 6/06" the bed need is projected to be 256; for the year "7/06 - 6/07" the bed need is projected to be 261; and, for the year "7/07 - 6/08" the bed need is projected to be 266. See Select Ex. 1, Bates Stamp p. 000036 and the testimony of Ms. Greenberg at tr. 114. If the use rate analysis had been re-computed to include two districts whose data was excluded from the analysis, the bed need yielded for Palm Beach County alone was 175 beds, a numeric need still in excess of the 130 beds proposed by both applicants. The use rate methodology is reasonable.4 The length of stay methodologies are also reasonable. These two methodologies also yielded numeric need for beds in excess of the 130 beds proposed. The two methodologies yielded need for 167 beds and 250 beds. Agency Denial The Agency's general concerns about LTCHs are not without basis. For many years, there were almost no LTCH CON applications filed with the Agency. A change occurred in 2002. The change in the LTCH environment in the last few years put AHCA in the position of having "to adapt to a rapidly changing situation in terms of [Agency] understanding of what has been going on in recent years with long-term care hospitals." (Tr. 358.) "... [I]n the last couple of years long-term care hospital applications have become [AHCA's] most common type of application." (Tr. 359.) At the time of the upsurge in applications, there was "virtually nothing ... in the academic literature about long- term care hospitals ... that could [provide] ... an understanding of what was going on ... [nor was there anything] in the peer reviewed literature that addressed long-term care hospitals" id., and the health care planning issues that affected them. Two MedPAC reports came out, one in 2003 and another in 2004. The 2003 report conveyed the information that the federal government was unable to identify patients appropriate for LTCH services, services that are overwhelmingly Medicare funded, because of overlap of LTCH services with other types of services. The 2004 report gave an account of the federal government decision to change its payment policy for a type of long-term care hospitals that are known as "hospitals-within- hospitals" (tr. 368) so that "hospitals within hospitals as of this past summer [2004] can now only treat 25 percent of their patients from the host hospital." Id. Both reports roused concerns for AHCA. First, if appropriate LTCH patients cannot be identified and other types of services overlap appropriately with LTCH services, AHCA cannot produce a valid needs assessment methodology. The second produces another concern. In the words of Mr. Gregg, The problem ... with oversupply of long-term care hospital beds is that it creates an incentive for providers to seek patient who are less appropriate for the service. What we know now is that only the sickest patient ... with the most severe conditions are truly appropriate for long-term care hospital placement. * * * ... [T]he MedPAC report most recently shows us that the greatest indicator of utilization of long-term care hospital services is the mere availability of those services. Tr. 368-369. The MedPAC reports, themselves, although marked for identification, were not admitted into evidence. Objections to their admission (in particular, Kindred's) were sustained because they had not been listed by AHCA on the stipulation required by the Pre-hearing Order of Instructions.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued by the Agency for Health Care Administration that: approves Select-Palm Beach's application, CON 9661; and approves Kindred's application CON 9662 with the condition that financing of the project be provided by Kindred Healthcare. DONE AND ENTERED this 18th day of April, 2005, in Tallahassee, Leon County, Florida. S DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of April, 2005.
The Issue Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, he then had an "emergency medical condition," as defined by Section 395.002(8)(a) F.S. Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, MRMC provided to the patient appropriate "emergency services and care," including an appropriate "medical screening, examination and evaluation," as defined by Section 395.002(9) F.S., and as required by Section 395.1041 F.S., and if not, how shall MRMC be disciplined?
Findings Of Fact At all times material, J.B. was a 42 year old male employee of an Ocala music store. In that capacity, he had been moving pianos for years. As a result, he had experienced neck, shoulder and back pain off and on for years. The pain and stiffness was worst upon awaking in the mornings and frequently required two days' bed rest before he could return to work. In the week preceding Monday, May 22, 1995, J.B.'s neck and shoulder pain had intensified. On Friday, May 19, 1995, J.B. went to a walk-in clinic, CARE-ONE, because his primary care physician was out of town. He was examined by a physician; x-rays were taken; he was issued a soft cervical collar; and he was prescribed a muscle relaxer and pain medication, both of which are "scheduled" drugs. The CARE-ONE physician also advised him to see a neurosurgeon for further evaluation and treatment. Despite his use of the prescribed drugs, J.B.'s pain intensified further over the weekend, to the point he was weeping and vomiting on occasion. He also had new pain in his left arm. At all times material, Respondent MRMC in Ocala, Florida, was licensed as a Class I general hospital with an emergency department. MRMC's emergency department handles upwards of 40,000 patient visits annually. At 8:15 a.m. on Monday, May 22, 1995, J.B.'s wife, L.B., took him to the MRMC emergency department. The term, "triage", generally refers to a means of sorting and prioritization of patients based on a superficial initial examination to determine how rapidly they will be seen in a mixture of patients who have differentiated complaints. Emergency department Board-certified physicians established MRMC's medical triage protocols in 1989. In so doing, MRMC has melded the concept of initial patient evaluation and "triage" into one process, and has authorized registered nurses, among other health care professionals, to perform both functions. MRMC's emergency department staff numbers 75 FTEs at all times, plus physician and physician assistant components. Physicians are available on the premises 24 hours a day for any consultation that may be required. At all times material, Geraldine Sweeney was an MRMC Clinical III Emergency Department Triage Nurse. As such, she maintains 24 hours of continuing education units per years (twice the number required to maintain her R.N. license). She also regularly participates in in-service training in emergency department nursing. These courses regularly include neurological topics and she has encountered and assessed numerous neurological cases over her 16 years in MRMC's emergency department, six of them as triage nurse since MRMC established its dedicated triage system in 1989. Ms. Sweeney has both an associate of arts and an associate of science degree in nursing; is a fully licensed Registered Nurse; and has never had any disciplinary action taken against her license. She was accepted as an expert in hospital emergency nursing. At formal hearing, J.B. did not remember being seen by any health care professional at MRMC on May 22, 1995. His wife, L.B., was attending to registration procedures with an MRMC admittance clerk in a different room and was not present when J.B. was assessed at MRMC's emergency department on that date, but she knew he was taken to a different room by a female hospital employee whom L.B. presumed to be a nurse. Geraldine Sweeney, R.N., did not recognize J.B. at formal hearing. She has "triaged" at least 1,000 patients since May 22, 1995. However, despite these three witnesses' lapses in memory or lack of opportunity to observe and/or lack of independent recollection, MRMC's documentation for May 22, 1995, in Ms. Sweeney's handwriting and bearing her signature, shows that Ms. Sweeney is the only MRMC health care professional who performed its initial, and only, assessment of J.B. at MRMC on May 22, 1995. Ms. Sweeney's contemporaneous documentation of her examination of J.B. shows he arrived at MRMC's emergency department at 8:15 a.m. and was "triaged" at 8:15 a.m. She wrote down that subjectively, he presented with a "history of neck problems with spasms; now has pain into left arm; seen at CARE-ONE Friday; had x-rays; given valium and lortab; advised for neurosurgeon." His objective vital signs were recorded by Ms. Sweeney as, "temperature 36.4 C., pulse 62, respiration 20, blood pressure 130/75." No weight was recorded. The only other significant objective triage data Ms. Sweeney recorded was, "Wearing soft collar; ambulates well; grips equal." Ms. Sweeney classified J.B. according to MRMC's physician-established protocols as "Class I, not requiring immediate attention," and he was released from the MRMC emergency department at 8:25 a.m., just ten minutes after his arrival. At that time, he was provided with a written list of other treatment locations to which he could go, including CARE-ONE again, and his personal physician. This list did not name any other hospital emergency department. Richard S. Slevinski, M.D., is Board-certified in emergency medicine and is director of the emergency department at Baptist Hospital in Pensacola, Florida, which includes a Level II Trauma Center. He was accepted as an expert in emergency and general medicine. Dr. Slevinski and Nurse Sweeney testified that a loss of function is a significant phenomenon that should have been recorded in a proper evaluation. Ms. Sweeney testified that if J.B. had identified loss of function as a symptom to her or if she had discovered a loss of function during her examination, she would have noted that and followed up with additional tests, but J.B. did not subjectively describe loss of function and she did not objectively observe any loss of function. Dr. Slevinski and Nurse Sweeney testified that a change in function or location of pain, increase in intensity of pain or recent onset of pain are subjective indicators that should be recorded if related by the patient during an examination and evaluation. Ms. Sweeney testified that she would have recorded any of these subjective symptoms if J.B. had related them to her, but he did not. Nurse Sweeney also testified that none of the objective vital signs she recorded during her examination of J.B. on May 22, 1995 indicated severe or intense pain. This was corroborated by neurosurgeon Dr. Barry Kaplan. (See Finding of Fact 32) I accept Dr. Slevinski's expert opinion that as a medical physician, he has found that if a service was provided in an emergency department it should be documented, and that it is the duty of the emergency department professional who performs patient screenings, examinations and evaluations to inquire adequately of a patient to find out what is going on with him or her and to make a chart so that later someone else can read the chart and see what the examiner did, and I reasonably infer from this expert testimony that, absent some strong evidence to the contrary, if a service has not been documented, the service has not been performed. This analysis, however, does not support a finding that J.B. actually told Nurse Sweeney on May 22, 1995 that his overall pain or his left arm pain was newly onset, that his pain had intensified, or that his pain was more localized in his left arm. J.B. has described his pain as chronic or recurring over a long period of time in testimony and when he saw Dr. Kaplan, a neurosurgeon, on June 1, 1995 (see Findings of Fact 27, 29), and J.B. can remember nothing about what he told Nurse Sweeney on May 22, 1995. Therefore, this is a situation in which Nurse Sweeney's testimony about what J.B. did not tell her is unrefuted, rather than the classic situation, described by Dr. Slevinski, in which a patient testifies as to what symptoms he told a health care professional and the chart shows the health care professional failed to record what the patient said. However, upon the evidence as a whole, it is found that no full neurological evaluation of J.B. was done by anyone at MRMC; that Nurse Sweeney did not individually feel each of his fingers to ascertain if he had sensation and similar temperature in each; and that she did not administer any muscle resistance tests. Rather, she had J.B. perform a "grip test". This "grip test" is performed by having the patient lift and cross his arms and reach out to the examiner. It tests whether the patient is able to maneuver both his own hands forward and grab onto the examiner's fingers with equal pressure, thereby indicating lack of loss of arm function. The test permits skin to skin contact so that any loss of sensation in the patient's hands or any change or inequality of skin temperature in the patient's hands or digits can be noted by the examiner. Upon her education, training, and experience, Nurse Sweeney thereby determined that J.B.'s grips were equal and his skin was a normal temperature, indicating no loss of function, sensation, or failure in circulation. Dr. Slevinski testified that, if J.B. had presented his CARE-ONE x- rays to her, Ms. Sweeney should have had the CARE-ONE x-rays read by a qualified physician, preferably a neurologist. Ms. Sweeney denied that J.B. brought his x-rays with him to MRMC, stating that if he had done so, she would have recorded that on the assessment form and would have had them read by a qualified physician instead of just recording, "had x-rays," which she had meant to show that J.B. had had x-rays taken the Friday before at CARE-ONE. J.B.'s testimony is clear on this single point to the effect that he had his wife take him to get the CARE-ONE x-rays and had them with him at MRMC. Marion Community Hospital documented that J.B. had the CARE-ONE x-rays with him at that facility at 9:23 a.m. (See Findings of Fact 24-25) This is corroborative of J.B.'s testimony on this issue. I therefore find that Ms. Sweeney overlooked those available CARE- ONE x-rays as part of her evaluation of J.B. Dr. Slevinski opined that MRMC, through Nurse Sweeney, did not provide an adequate medical screening examination for J.B.'s presenting complaint on May 22, 1995 because he was not given an appropriately sophisticated neurologic assessment or examination of the involved extremity (left arm) by a physician, preferably a neurologist; because the CARE-ONE x-rays J.B. brought with him were not reviewed by a qualified person; and because his pain was not stabilized. Specifically, Dr. Slevinski faulted Ms. Sweeney's use of a "grips" examination instead of an examination of J.B.'s status of sensation, strength of fingers, or reflex capabilities. He opined that Ms. Sweeney's examination, as documented, was insufficient to rule out that J.B. had a condition that was going to cause him further damage. It was Dr. Slevinski's opinion that "triage", as generally understood by the community of health care professionals, without more, cannot constitute an adequate or appropriate medical screening, examination, and evaluation. In Dr. Slevinski's view, severe pain alone qualifies as an emergent or emergency condition until an adequate examination proves that it is not. However, Dr. Slevinski conceded that pain is highly subjective and is only an "emergency medical condition" if the absence of immediate medical attention could reasonably be expected to result in serious jeopardy to the patient's health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. Upon further questioning, Dr. Slevinski opined that in general, a medical screening examination or evaluation need not always be done by a physician; that it can be done by a nurse or even a psychological case worker in the appropriate circumstances; and that in some, but not necessarily all patient presentations, there is no reason a triage nurse, within the scope of her license, if authorized to do so by the hospital, cannot perform a medical screening examination simultaneously with triage, although that is not his preference and although that was not appropriate in this case or in all cases. Dr. Slevinski commented also that a failure to correctly diagnose and treat after an appropriate screening, examination, or assessment might subject a hospital or individual health care provider to civil liability but would not violate Chapter 395 F.S. After J.B., still in pain, had been returned from the examining room, that is, only after Nurse Sweeney had already finished her evaluation of him and determined that he did not have an emergency medical condition requiring further emergency treatment and care, and while J.B. was standing beside L.B. facing the administrative clerk in the registration area of the MRMC emergency department, L.B. handed her insurance card to the clerk. The clerk then told L.B. that J.B. could not be treated at MRMC because he did not have either a referral from his primary treating physician or a life-threatening condition. An argument ensued, and L.B. demanded to know where else she could get treatment for J.B. She then drove J.B. directly to Marion Community Hospital's emergency department upon the suggestion of MRMC's admissions clerk. J.B. was clocked-in at 9:23 a.m. at the emergency department of Marion Community Hospital a/k/a "Columbia" or "HCA", where he was kept for about five hours. He was examined by an in-house neurologist who performed a limited "hands on" physical examination and a neurological examination. His vital signs were taken. He was injected intramuscularly with 30 milligrams of toradol, a "scheduled" pain killer. He was observed and re-evaluated after several hours. Additional x-rays were taken and reviewed by a radiologist who also reviewed the CARE-ONE x-rays J.B. had brought with him. J.B.'s valium and lortab prescriptions were refilled. He was released from Marion's emergency department with instructions to call and schedule an MRI and also to see his own physician and a neurosurgeon. The only medical "treatment" J.B. received at Marion was for pain. The final result after Marion's extensive and expensive screening examination and evaluation was the same as had occurred at MRMC: that he was released because he had no emergency medical condition requiring further emergency medical treatment in that facility at that time. Barry Kaplan, M.D., is the Board-certified neurosurgeon who eventually performed successful surgery on J.B. Dr. Kaplan first saw J.B. in his office on July 1, 1995. The length of this visit is not clear on the record. J.B.'s general description to him was that of chronic pain. Apparently J.B. had gone back to work for part of the time between May 22, 1995 and seeing Dr. Kaplan on June 1, 1995. On June 1, 1995, Dr. Kaplan did a complete neurologic examination, which included testing J.B.'s muscle actions against resistance. He also felt all of J.B.'s fingers, individually, while asking about sensation in each. These tests revealed only mild weakness or dysfunction in the bicep muscle of J.B.'s left arm and only mild numbness or dysfunction in his left arm. Dr. Kaplan also reviewed an MRI taken of J.B. on May 31, 1995 which demonstrated a chronic arthritic condition of J.B.'s neck, with bone spurs pressing the nerves running to his left arm and spinal cord, which resulted in J.B.'s pain. In Dr. Kaplan's opinion as an expert in neurosurgery and general medicine, J.B.'s condition on June 1, 1995, could not have developed measurably within the time elapsed since his visit to the MRMC emergency department on May 22, 1995 or even within the last month, because on June 1, 1995, J.B. had no acute symptoms of sufficient severity that he then had immediate need of treatment, nor was there any reasonable expectation that lack of treatment could be expected to result in serious jeopardy to his health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. On June 1, 1995, Dr. Kaplan believed that J.B.'s condition could be left alone for another four to six months before any permanent injury would occur to his spinal cord, but due to J.B.'s intense and chronic pain and relative youth, he recommended elective surgical removal of certain discs. Dr. Kaplan did the recommended elective surgery at J.B.'s request on July 12, 1995 at MRMC. J.B. has been pain-free since recovery. Dr. Kaplan's opinion also was that none of the objective vital signs recorded by Nurse Sweeney on May 22, 1995 would be consistent with severe pain. Although he was aware that Nurse Sweeney did not record giving a numbness test, weakness test, or reviewing x-rays on May 22, 1995, Dr. Kaplan also opined that, "Unless somebody has quadriparesis or complete dysfunction of a part from a cervical disc problem, then it is not an emergent condition . . . . Unless they have severe weakness or numbness to go along with the pain, there's no indication for emergency intervention." Dr. Kaplan's opinion also was that no serious jeopardy could have been incurred by J.B. not receiving further emergency services and treatment beyond MRMC's initial assessment on May 22, 1995. No health care witness set a minimum time necessary to conduct an appropriate examination. All indicated that the time involved and appropriate tests varied from case to case.
Recommendation 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 the administrative complaint herein. RECOMMENDED this 17th day of December, 1996, at Tallahassee, Florida. ELLA JANE P. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1996. COPIES FURNISHED: Thomas W. Caufman, Esquire Agency for Health Care Administration 7827 North Dale Mabry Highway No. 100 Tampa, Florida 33614 Thomas D. Watry, Esquire 1500 Marquis Two Tower 285 Peachtree Center Avenue Northeast Atlanta, Georgia 30303 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Jerome W. Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
Findings Of Fact Memorial Hospital of Jacksonville, Petitioner, seeks, via a variance, approval of an intensive care/coronary care unit (ICU/CCU) in excess of the 5,000 square foot requirement of the 1973 Life Safety Code, which has been adopted and is enforce by the Department of Health and Rehabilitative Services (Respondent herein), pursuant to Rule 10D-28.79, Florida Administrative Code. The unit size in question is approximately 11,540 square feet, which is, of course, approximately twice the size of the ICU/CCU unit size permitted by the 1973 Life Safety Code. The Respondent disapproved the Petitioner's request for a variance based inter alia on the fact that the Petitioner's plans, as presented, exceeded the 5,000 square foot requirement by approximately 6,000 square feet and due to the fact that the number of feet from the patient beds to the exits was in excess of the 50 feet exit requirement set forth in the 1973 Life Safety Code. Rudolph Nudo, Petitioner's Director of Engineering for approximately thirteen years, studied the plans presented for approval by Respondent and has been involved in the variance request from the outset. During January of 1978, Petitioner engaged the architectural firm of Ellerbe and Associates to arrive at a design that would be efficient both in terms of space utilization and in terms of cost efficiency. Based on its studies, Ellerbe decided upon a triangular design. The working drawings, plans and specifications were submitted to the City of Jacksonville for approval, which approval has been granted. The City of Jacksonville`s code is patterned largely from the 1973 Life Safety Code. During a meeting with the Respondent's agents during August of 1978, Respondent's officials voiced concern about the excessive square feet contained in the ICU/CCU unit and, based therein, formally submitted a letter of denial to Petitioner based on the excessive square feet. Presently, exterior construction has commenced on the proposed unit and Petitioner is now awaiting approval of its interior construction plans. Petitioner has indicated its desire to comply fully with all other requirements in terms of the necessary time/ratings for the fireproofing of walls, et cetera. In terms of other safety precautions, the Petitioner regularly conducts safety inspections and fire drills. Petitioner has not been cited for any safety infractions by the Respondent. Don Benson, the architect employed by Ellerbe and Associates assigned to this project, has been engaged in the design of medical facilities since approximately 1964. The plans, as submitted, have space to accommodate approximately twenty-four beds for coronary and intensive care patients. As stated, the design is triangular and the monitoring station is semi-circular. (See Petitioner's Exhibit A.) The burn factor for the wall is rated by Underwriters Laboratories (UL) for a period of up to two hours. The facility as planned is a one-story unit and is designed for easy ingress and egress to other adjacent units. Dr. Kay E. Gilmore, M.D., a cardiologist who has specialized in heart and vascular diseases for approximately seven years, was a member of the Petitioner's in-house committee charged with studying and implementing the design for the proposed ICU/CCU unit. Prior to submittal of the proposal, Dr. Gilmore visited various sites to study other ICU units which were operational. Dr. Gilmore, as did other witnesses, noted that in ICU units, a primary concern is that of complete visualization and monitoring of patients at all times. Dr. H. Azcuy, M.D., who has been engaged in the practice of pulmonary medicine since approximately 1964, is Petitioner's Director of Respiratory Therapy. Dr. Azcuy is a member of the Critical Care design unit committee and has been instrumental with the planning for the proposed facility. Dr. Azcuy remarked that most patients which he treats have respiratory problems and that all patients in the intensive care unit are prohibited from smoking due to the presence of oxygen in the critical care units. Vernon Wallace, Petitioner's biomedical engineer, is in charge of the procurement and maintenance of all patient care equipment at the facility. Recognizing that fire hazards are potential problems in all hospitals, Messr. Wallace testified that all equipment purchased by Petitioner is of high-level workmanship, most of which operates on very low voltage, thereby reducing the likelihood of fires. Messr. Wallace testified that during his tenure with Petitioner, no fire has occurred at the hospital nor has it been necessary to evacuate patients for any reason. Mary Nikoden, an R.N. for approximately thirty-three years and Petitioner's Director of Nursing for the past ten years, has been employed in many phases of patient care at hospitals and nursing homes. Ms. Nikoden testified that patients are interchanged regularly from the intensive care units to the critical care units as patient load fluctuates. She cited one problem, i.e., the movement of patients from the ICU/CCU units which is hampered due to the bulky equipment and the necessity to constantly monitor intensive and critical care patients. She opined that if the units were combined, patient care would be enhanced due to the fact that similarly trained employees work in both units. She also pointed out that the proposed design would increase patient care due to the fact that patients can be observed at all times and access will be increased and/or enhanced if the proposed design is approved. Karen Cornelius, a registered nurse who holds a master's degree in nursing, has been employed at Memorial Hospital since approximately September of 1976. From 1964 through 1967 she was employed at Cornell University Hospital and from 1967 through 1970 she was head nurse in charge of the surgery and intensive care units at Cornell. She was employed at Grady Memorial Hospital in Atlanta from 1970 through 1973, and from 1973 through 1975 she trained personnel in the intensive care and coronary care units at Grady Memorial Hospital. Ms. Cornelius was involved in the input and the design of the room sizes for the proposed unit. According to Ms. Cornelius, one of the basic reasons for the proposed design is to maximize the use of the staffs from the intensive care and coronary care units who are regularly interchanged and cross-coordinated. Ms. Cornelius has visited and compared other area hospital intensive care and coronary care units and is of the opinion that the proposed plan is far superior due to the easy patient visibility and the ability to constantly monitor patients' vital signs. During the year of 1978, Petitioner submitted a request for an equivalency (waiver) from the Joint Commission on Accreditation of Hospitals, which approval was granted in early March, 1979, with certain recommendations and conditions respecting exit requirements; the necessity to increase the frequency of fire drills, installation of adequate fire extinguishers and smoke exhaust systems and single-story construction (Petitioner's Exhibit 8). John T. Ludwig, an electrical engineer who holds a Ph.D. in engineering, has had vast experience in various engineering positions. Messr. Ludwig received his Ph.D. in 1954 and relocated to Pinellas County during 1966. Since 1971, he has been employed by the Respondent in the Bureau of Health Facilities, where he is now in charge of the review of plans for nursing homes and hospitals. Messr. Ludwig concluded that the Petitioner's plans as proposed were unsafe due to the "failure to consider fire safety and the undue risks of harm which would result to patients' lives if the proposed plans here approved." Among Messr. Ludwig's concerns were the facts that intensive care and coronary care patients differ with respect to the type of life support equipment necessary to maintain proper patient care; potential problems which might result due to the distance between patient suites and exits; corridor problems (the storing of combustibles in the hallways) and the inability to visualize patients from the central nursing station due to the triangular design. Max C. Karrer, M.D., is an associate of Memorial Hospital who specializes in obstetrics and gynecology. Dr. Karrer is a member of the committee charged with investigating the concept for the proposed critical care/intensive care unit. As a member of this committee, Dr. Karrer visited intensive care and critical care units of Hollywood, California; Pittsburgh, Pennsylvania; the University of Maryland Trauma Center; Machua General Hospital and a hospital in Cambridge, England. Dr. Karrer concluded that the proposed plan was one of the better plans he had observed because, among other things, personnel use would be maximized; better use could be made of patient beds; better care would result based on the number of dollars spent and the utilization of and the interchange of staffs from the intensive care and coronary care units. Additionally, he noted that the proposed plan made possible the ability to constantly visualize patients and was by far the best designed intensive care unit he had seen. During the examination of Dr. Karrer, it was brought out that the hospital dispenses medication on the unit-dosage system and all stored linens in the proposed unit was of the fire-retardant type. Thus, he concluded that the likelihood of a fire was remote in this unit since no combustibles are stored in the corridors as charged by Respondent's agents. Ben F. Britt, a registered architect licensed to practice in Maryland, Virginia, South Carolina, North Carolina and Florida, has practiced architecture for approximately fifteen years and is presently the Medical Facilities' architect for Area I in Florida. This area has approximately eighty-four hospitals and more than ninety nursing homes. Messr. Britt testified that the spread of fire was the primary reason that the Life Safety Code of 1973 restricted the area for an intensive care or coronary care unit to 5,000 square feet. He also cited the problem respecting the transfer of patients who necessarily had attached to their person monitoring equipment which could not be easily moved from one location to another. Messr. Rudolph Nudo was recalled to emphasize the fact that the Petitioner reviewed all safety codes when the subject design was implemented and that there were no linens stored which were not of the fire retardant type; that inasmuch as the Petitioner dispenses medication on the unit system, no boxes are stored in the hallways which could be the source of a potential fire hazard. Messr. Nudo also testified that the Petitioner would install the necessary exits to comply with all codes which the Respondent enforces. He testified that the additional size was justified in this case based on the additional safety features which were present in the design and the type of equipment utilized. Messr. Benson was recalled to emphasize the fact that the proposed unit consists of single rooms which were the optimum in coronary care units and that the trend in intensive care and coronary care units is toward centralization of such units.
