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
Findings Of Fact CON APPLICATIONS HCR-CON No.7530 HCR is a publicly owned, for-profit corporation which operates approximately 25 nursing homes in Florida. HCR filed an application, CON No. 7530, to construct a 98-bed freestanding nursing home. HCR proposes to locate the nursing home in the northwest part of Orange County, Florida. HCR proposes that the entire 98-bed facility will be dedicated to the care of patients with Alzheimer's Disease and related dementias. The total cost of the HCR project is $7,132,000 for 47,750 square feet, or $472,776 per bed. The HCR proposal is modeled after an HCR 120-bed nursing home facility in Boynton Beach, Florida. The Boynton Beach facility is entirely dedicated to the treatment of patients with Alzheimer's Disease or related dementias. The proposed HCR facility in Orange County would be identical to the Boynton Beach facility less one patient wing. HCR's Boynton Beach facility, as well as HCR's existing Orange County nursing home facility, have superior licensure ratings. HCR's Boynton Beach facility received accreditation with commendation from the Joint Commission on the Accreditation of Health Care Organizations (JCAHCO), a national accreditation body which has established standards to measure the quality of care in dementia care units. Dementia is a complex of symptoms that can be caused by many different underlying diseases. Alzheimer's disease is one cause of dementia. Alzheimer's disease is the most common cause of dementia. Significant research is being conducted into the cause and treatment of Alzheimer's disease. Dementia is defined as a decline in intellectual function; global cognitive impairment, that is memory impairment and at least one of the following: impairment of abstract thinking; impairment of judgment; impairment of other complex capabilities such as language use, ability to perform complex physical tasks, ability to recognize objects or people, or to construct objects; and, personality change. The Reisberg Cognitive Rating Scale (RCS) classifies the stages of Alzheimer's disease from 1 to 7, with a rating of 7 being most severe. The rating scale is based on 10 axes: concentration, recent memory, past memory, orientation, functioning and self-care, speech, motor functioning, mood and behavior, practice of an art or skill, and calculation ability. The Global Deterioration Scale (GDS) for Age-Associated Cognitive decline and Alzheimer's Disease also defines seven stages of deterioration ranging from no cognitive decline to very severe cognitive decline. Persons suffering from Alzheimer's disease generally cannot survive without assistance upon reaching early dementia or level five on both the RCS and GDS. Approximately 50-58 percent of persons currently residing in community nursing homes suffer from some form of dementia. There is a need for community nursing home beds for persons suffering from the latter stages (levels 5-7) of Alzheimer's disease in Orange County. It is particularly difficult to place in nursing homes in Orange County, persons suffering from the latter stages of Alzheimer's disease (levels 5-7) who also have displayed a history of disruptive behavior patterns. Persons suffering from the latter stages of Alzheimer's disease have specific needs for care and treatment in nursing homes. Alzheimer's victims tend to wander and should have areas set aside for secured walking. The movement of Alzheimer's victims should also be carefully monitored. HCR's Boynton Beach facility, which is the prototype for HCR's proposed Orange County facility, has specific design features to accommodate the needs of patients suffering from the latter stages (levels 5-7) of Alzheimer's disease. HCR proposes a pod design of five residential pod units each with a central living area, also called the atrium area. The resident rooms open to the central living area. Each pod has an enclosed courtyard. Access to the courtyards is controlled. The two nursing stations are centrally located in each wing of the facility. Each central living area, or atrium, is visible from one or the other of the nursing stations. HCR provides specific staff training in the care and treatment of Alzheimer's disease and related dementias. A unit or a facility dedicated to the treatment of dementia patients may reduce the need for psychotropic medication of the patients. On a long-term basis, there may be some staff burnout in a facility or unit dedicated solely to the care and treatment of victims of Alzheimer's disease or related dementias. HCR proposes that its CON be conditioned upon locating in northwest Orange County, providing at least 30 percent of its patient days to Medicaid eligible persons, providing respite care, and dedicating all 98 beds to the care and treatment of persons suffering from Alzheimer's disease and related dementias. HCR currently meets its Medicaid commitment in the Boynton Beach facility. LIFE CARE CON Nos. 7534 and 7534P LIFE CARE is a for-profit corporation which owns and operates two nursing homes in Florida. LIFE CARE also operates three other nursing homes in Florida. As of September 1993, LIFE CARE had a net worth of approximately $50 million. LIFE CARE proposes to construct a freestanding 98-bed nursing home (CON No. 7534) in southwest Orange County, at a total cost of $5,988,000. The LIFE CARE 98-bed facility proposal includes a 20-bed unit dedicated to the care and treatment of persons suffering from Alzheimer's disease, a 20-bed subacute unit, an adult day care center, mental health services, and services to persons suffering from AIDS/HIV. LIFE CARE also made a partial request (CON No. 7534P) for a 60-bed facility which would be constructed at the same site and would include the same features. For economic reasons, patients are being released from acute care hospital settings at earlier stages of recovery and there is a need for subacute nursing home services in Orange County. The incidence of AIDS/HIV is increasing and there is a need for nursing home services for persons suffering from AIDS/HIV in Orange County. The 20-bed unit proposed by LIFE CARE for the care and treatment of Alzheimer's patients will be a distinct part of the facility, separate from other residents. The Alzheimer's unit has its own dining area and activity area, a centrally located bathing facility, and a secured courtyard for wandering space. The 20-bed LIFE CARE subacute unit will also be separate. The subacute unit will have two ventilator areas and be contiguous to a therapy area. The LIFE CARE design includes outdoor courtyards, a library, gift shop, and ice cream parlor. Pursuant to Sections 408.037(2)(a) and (b), Florida Statutes, one of the required elements of a CON application is the listing of capital projects, which is presented in Schedule 2 of the CON application. The Schedule 2 filed by LIFE CARE in these proceedings is identical to the Schedule 2 filed by LIFE CARE in the December 1993 batching cycle for LIFE CARE'S proposed Clay County Project, CON No. 7501. It has been held that Schedule 2 of the LIFE CARE Clay County Project CON application No. 7501 met minimum CON application content requirements. Life Care Centers of America, Inc. v. State of Florida, Agency for Health Care Administration, 20 F.L.W. 1435 (Fla. 1st DCA June 12, 1995). During November of 1993, a LIFE CARE nursing home located in Altamonte Springs was downgraded from a superior to a conditional licensure rating due to a deficiency related to outdated medication. The conditional rating given to the facility was in effect for approximately fifty days. The facility was then given a standard rating, and upon the annual survey in the fall of 1994, the facility has been recommended for a superior rating. All other LIFE CARE facilities have superior ratings. LIFE CARE proposes to condition its CON application upon providing Medicaid participation of 65 percent in the 98-bed facility, and 43 percent in the 60-bed facility. ADVENTIST CON No. 7528 ADVENTIST is a not-for-profit corporation that owns and operates nursing homes, hospitals, and other health care related enterprises. ADVENTIST is a wholly owned subsidiary of Adventist Health System/Sunbelt Health Care Corporation, which owns and operates hospitals and health care facilities throughout the United States. ADVENTIST has operated health care facilities in Orange County since the early 1900s when Florida Hospital was founded. ADVENTIST is the largest hospital system in Orange County, with more than 1,400 beds located on five campuses. ADVENTIST proposes to add 38 beds to an existing freestanding 80-bed community nursing home, Sunbelt Living Center-East Orlando (SLC), which is directly adjacent to Florida Hospital's East Orlando campus. The ADVENTIST proposal would include a 20-bed subacute unit and also an 18-bed skilled nursing unit. This addition to SLC would be accomplished by constructing two new wings to the existing facility. The projected cost of the ADVENTIST addition is $1,386,500, or approximately $36,000 per bed. SLC is an 80-bed skilled nursing facility which opened in January of 1993. SLC has a superior licensure rating. SLC provides nursing home service to a variety of residents, including persons with AIDS/HIV, as well as persons with a primary diagnosis of Alzheimer's disease and related dementia. SLC does not have a distinct Alzheimer's unit, but is equipped with security features to accommodate Alzheimer's patients. SLC staff is trained in the care and treatment of all its residents, including those with dementia. SLC reached an occupancy rate of 96 percent-97 percent capacity in its first ten months of operation. The SLC design is based on a residential model. The intent of the design is to create a residential community, and to encourage the interaction among the residents, and also between the residents and staff. The residential wings contain twelve rooms with private and semiprivate accommodations. Each room has its own toilet facilities. The support facilities, food service, therapy areas, administrative offices, visitor and welcoming areas, are located in the center of the facility. The residential wings are clustered on each side of the facility. The facility also features outdoor courtyards and walkways adjacent to the residential wings. ADVENTIST proposes to condition its CON application on providing a Medicaid commitment of 65 percent of total patient days in the non-subacute wing of the 38-bed expansion. The ADVENTIST proposal also features an AIDS program and respite care. ADVENTIST currently meets it Medicaid commitment at SLC. As indicated above, there is a need for subacute nursing home beds in Orange County. There is a need for nursing home beds for persons suffering from AIDS/HIV in Orange County. In the 20-bed subacute unit ADVENTIST proposes that each room will include wall-mounted suction and gases to accommodate ventilator dependent patients, which will enable ADVENTIST to provide more intensive subacute care. RHA/PRINCETON CON No.7538 RHA is the owner and operator of Princeton Hospital, located on the west side of Orlando. Princeton Hospital is situated on 32 acres bordering Lake Lawne. Princeton Hospital has 150 beds, including 24 psychiatric beds, a multipurpose intensive care unit, a 13-bed progressive care unit, a nursery, pediatric services, women's services, an obstetrical unit and an inpatient cardiac catheterization lab. The psychiatric unit at Princeton Hospital treats a wide range of mental disorders, including those afflicting the elderly population. The hospital also operates a senior psychiatric partial hospitalization program which serves geriatric patients, including persons suffering from Alzheimer's disease and related dementias. Princeton Hospital currently provides care and treatment to persons suffering from AIDS/HIV. Princeton Hospital is accredited by the Joint Commission on Accreditation of Health Care Organizations. On August 1, 1994, subsequent to the filing of CON application No. 7538, Princeton Hospital entered into a wide-ranging affiliation agreement with the University of Florida, College of Medicine and Shands Hospital. The agreement provides for extensive reciprocal training and educational programs between Princeton Hospital and the College of Medicine, as well as Shands Hospital. The agreement also provides for priority transfer of patients between Princeton and Shands hospitals. RHA proposes to include its nursing home facility within the scope of the affiliation agreement. The nursing home staff would benefit from the training and educational opportunities, and the nursing home patients would have access to priority reciprocity with the College of Medicine and Shands Hospital as provided for in the agreement. During fiscal years 1993 and 1994 Princeton Hospital had a Medicaid patient ratio of approximately 40 percent. Princeton Hospital also provides indigent care. RHA proposes to construct a freestanding 60-bed Medicaid certified skilled nursing facility on the campus of Princeton Hospital at a cost of $4,991,961 for 43,741 square feet, or $83,199 per bed. The services that are proposed include subacute care, a 15-bed unit for persons suffering from Alzheimer's disease and related dementias, long term care, and two pediatric beds. Respite care will also be provided. RHA proposes that its subacute care unit would provide step-down care for patients referred from acute care hospital settings. RHA also proposes to provide rehabilitative therapies to serve patients suffering from fractured hips and joint replacements as well as other patients needing more intensive physical therapy. Cardiac and respiratory patients will also be served in the subacute unit. As indicated above, there is a need for subacute nursing home beds in Orange County. RHA's proposed 15-bed Alzheimer's unit will be a distinct and secured part of the facility. The unit will have its own enclosed courtyard and activities area. As indicated above, there is a need for nursing home beds for persons suffering from Alzheimer's disease and related dementias in Orange County. RHA also proposes a program dedicated to the care and treatment of persons suffering from AIDS/HIV. This program will provide long-term care, and will include psychiatric, as well as subacute services. As indicated above, there is a need for nursing home beds for persons suffering from AIDS/HIV in Orange County. The RHA proposal includes two pediatric nursing home beds. It is not uncommon to provide pediatric nursing home beds in a small unit within a nursing home facility. These beds will provide subacute care to pediatric patients referred from acute care hospital settings. It is anticipated that the pediatric unit will serve patients with respiratory problems and other multiple system failures. RHA has experienced difficulty in placing pediatric patients discharged from Princeton Hospital. The RHA facility is designed in a series of modules. There are four patient wings located around a single nursing station. The Alzheimer's wing is distinct and secured. The pediatric beds are located in a single semiprivate room close to the nursing station. The subacute unit includes six beds with wall-mounted medical gases and vacuums. Each residential room has approximately 272 net square feet, and features its own handicapped toilet and bathing facilities. The facility includes a chapel, convenience store, laundry, ice cream shop, and beauty shop, designed in a mall concept. The corridors are ten feet in width instead of the standard eight feet. The intent of the design concept is to encourage social interaction. As designed, the location of the soiled utility room in the facility does not comply with applicable Florida code regulations; however, a proposed minor change in the design will move the soiled utility room approximately twenty feet to bring the facility into compliance with Florida code regulations. ALLOCATION FACTORS Relationship to District and State Health Plans Section 408.035(1)(a), Florida Statutes District Health Plan Allocation Factor 1 of the District Health Plan provides a priority for an applicant proposing to locate in the northwest Orange County population center. This preference will continue to be given applicants until a total of 120 beds is obtained. HCR is the only applicant proposing to locate in the northwest Orange County population center; however, in January of 1993, Sunbelt Living Center, a 120-bed community nursing home opened in Apopka, Florida, which is located in the northwest Orange County population center. Accordingly, the total bed number for this preference has been obtained, and this district allocation factor is inapplicable to these proceedings. Allocation Factor 2 of the District Health Plan provides a preference for applicants developing specific services for newborn and/or pediatric patients. RHA is the only applicant proposing specific services which include a unit for the care and treatment of pediatric patients. Accordingly, RHA is the only applicant which meets this allocation factor. Allocation Factor 3 of the District Health Plan provides a preference for an applicant proposing to develop a specific specialty service (or services), such as a unit for medically complex patients, a unit dealing with psychiatric disorders as a primary diagnosis, or services for persons suffering from AIDS/HIV. This preference is also provided to an applicant which commits to working with, or in conjunction with, an existing provider of a specialty service, such as hospices, or mental health providers. RHA is the applicant which best meets this allocation factor. The RHA proposal provides for specialty services for medically complex patients, provides for services to persons suffering from AIDS/HIV, and RHA specifically commits to working with mental health providers, including working with the psychiatric unit at Princeton Hospital. ADVENTIST and LIFE CARE also propose to provide specialty services to medically complex patients in subacute units; however, the ADVENTIST facility is better equipped in this regard and is designed with piped in medical gases, vacuum, and expanded electrical capacity will have the capability to provide more extensive services. LIFE CARE also proposes to treat persons suffering from AIDS/HIV and persons with mental disorders. The LIFE CARE proposal, however, is not as specific in this regard as that of RHA. HCR proposes to provide specialty services to persons suffering from Alzheimer's disease and related dementias, and is in general compliance with this allocation factor. State Health Plan Allocation Factors Each applicant meets the first State Health Plan allocation factor which provides a preference for an applicant proposing to locate in areas within the subdistrict with occupancy rates exceeding 90 percent. The occupancy rate in Orange County exceeds 90 percent. RHA and LIFE CARE meet the second State Health Plan allocation factor which provides a preference for an applicant proposing to serve Medicaid patients in proportion to the average subdistrict-wide percentage of nursing homes. In Orange County the average is 65 percent for Medicaid service. ADVENTIST meets this preference with regard to its non-subacute unit. HCR which proposes a 30 percent Medicaid service does not meet this preference. The third State Health Plan allocation factor provides a preference to an applicant proposing specialized services to special care residents, including AIDS residents, Alzheimer's residents, and the mentally ill. Each applicant generally complies with this allocation factor and offers specialty services; however, RHA with its broader spectrum of specialty services, including services to AIDS/HIV residents, Alzheimer's residents, and its specific commitment to working with residents suffering from psychiatric disorders best meets this preference. The fourth State Health Plan allocation factor provides a preference to an applicant proposing to provide a continuum of services to community residents including, but not limited to, respite care and adult day care. RHA and ADVENTIST best meet this preference. RHA and ADVENTIST have a history of providing quality health care service to the community. RHA and ADVENTIST have extensive ongoing relationships with acute care hospitals. HCR and LIFE CARE have also established relationships which will address providing a continuum of care, but not to the extent proposed by RHA and ADVENTIST. The fifth State Health Plan allocation factor provides a preference to an applicant proposing to construct facilities which provide maximum resident comfort and quality of care. Each applicant proposes facilities designed to provide resident comfort and quality care. Each design has comfortable resident rooms, spacious activities areas, recreation areas, courtyards, landscaping, therapy rooms, and staff lounge areas. Each applicant meets this preference. The sixth State Health Plan allocation factor provides a preference for an applicant proposing innovative therapeutic programs which have proven effective in enhancing the residents' physical and mental functioning level and which emphasize restorative care. Each of the applicants' proposals feature specific elements of innovative therapeutic programs. HCR has received an award for its innovative design of the Boynton Beach Alzheimer's unit. RHA offers a multi-discipline approach with a psychiatric program. ADVENTIST offers an intensive subacute care unit, and LIFE CARE offer a well-balanced approach with intensive staff training. The seventh State Health Plan allocation factor provides a preference for an applicant proposing charges which do not exceed the highest Medicaid per diem rate in the subdistrict. In this respect, HCR projects Medicaid charges of $96.20 per patient day in Year 1, and $93.32 in Year 2. LIFE CARE projects Medicaid charges of $104.74 per patient day in Year 1, and $106.20 in Year 2. ADVENTIST projects Medicaid charges of $106.00 per patient day in Year 1, and $111.30 in Year 2. RHA projects Medicaid charges of $107.02 per patient day in Year 1, and $109.24 in Year 2. While HCR projects the lowest Medicaid per diem charges and appears to best meet this allocation factor, all applicants have agreed to a specified Medicaid utilization rate, and will accept the appropriate Medicaid reimbursement levels. The eighth State Health Plan allocation factor provides a preference for an applicant with a history of providing superior resident care in Florida or other states. HCR has maintained superior licensure ratings, and its prototype Boynton Beach facility currently is rated superior. LIFE CARE in 1993 experienced a conditional rating for its Altamonte Springs facility; however, the facility, upon evaluation in the fall of 1994, is now recommended for a superior licensure rating. RHA does not currently operate nursing homes; however, RHA has a history of providing quality care in its Princeton Hospital. ADVENTIST is the only applicant proposing to add nursing home beds to an existing facility that currently has a superior licensure rating, and in this respect, ADVENTIST best meets this allocation factor. The ninth State Health Plan allocation factor provides a preference to an applicant proposing staff levels which exceed minimum staffing standards contained in licensure administrative rules. Applicants proposing higher ratios of RNs- and LPNs-to-residents shall be given preference. All applicants meet this factor; however a comparison of the nursing staffing patterns of the applicants reflects that HCR (45.40 nursing FTE) and LIFE CARE (45.30 nursing FTE) have a higher than the minimum required ratio of nursing staff to residents for their proposed 98-bed facilities. RHA has proposed 35.30 nursing FTE for its 60-bed facility. ADVENTIST proposes a total 62.40 nursing FTE for its facility after the proposed 38-bed addition. The tenth State Health Plan allocation factor provides a preference for an applicant who will use professionals from a variety of disciplines to meet the residents' needs for social services, specialized therapies, nutrition, recreational activities, and spiritual guidance. These professionals shall include physical therapists, mental health nurses, and social workers. All the applicants offer a wide range of social, spiritual, nutritional, and recreational services. RHA, however, also proposes specific utilization of mental health care professionals, and a specific affiliation with the psychiatric care professionals from Princeton Hospital, and best meets this factor. The eleventh State Health Plan allocation factor provides a preference for an applicant who ensures the residents' rights and privacy, and who implements a well-designed quality assurance and discharge planning program. Each applicant has documented specific plans for quality assurance and ensuring the residents' rights and privacy are protected. Accordingly, each applicant meets this factor. The final State Health Plan allocation factor provides for a preference to an applicant proposing lower administrative costs, and higher resident care costs compared to the average nursing home in the district. HCR has the lowest projected administrative and overhead costs ($18.28 per patient day as of Year 2), and best meets this allocation factor. Statutory Review Criteria, Section 408.035(1), F.S. Section 408.035(1)(b): The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, inadequacy of like and existing health care services and hospices in the service district of the applicant. HCR, LIFE CARE, and RHA each proposes a unit dedicated to the care and treatment of persons suffering from Alzheimer's disease and related dementias (HCR 98-bed facility, LIFE CARE 20-bed unit, and RHA 15-bed unit). ADVENTIST, while currently providing care for Alzheimer's patients at SLC, does not propose a distinct Alzheimer's unit in its 38-bed addition. There are currently at least five nursing homes in the service district, and two others in close proximity, which feature dedicated Alzheimer's units, with a total of at least 345 nursing home beds serving Alzheimer's patients. There is a high utilization rate of Alzheimer's nursing home beds in the district. While there is an established need for more beds to serve Alzheimer's patients, particularly Alzheimer's patients with a history of disruptive behavior, there are additional needs in the service district to provide care and treatment for subacute patients, and for persons suffering from AIDS/HIV. It is difficult to quantify the need for subacute nursing home beds due to the differing professional definitions of what constitutes subacute care; however, acute care hospitals in Orange County are, for cost-effective reasons, now releasing patients on an earlier basis, and there is an established need for nursing home beds to accommodate persons released from acute care hospitals. There is a high utilization rate of subacute beds in the district. There has also been an increase in the incidence of AIDS/HIV patients, and in the need for nursing home beds for persons suffering from AIDS/HIV in the service district. Section 408.035(1)(c): The ability of the applicant to provide quality of care and the applicant's record of providing quality of care. Each applicant has the ability to provide quality of care, and each applicant has a history of providing quality of care. The distinguishing factors in this regard are that LIFE CARE is the only applicant that has experienced a downgrading of a nursing home facility from a superior to a conditional licensure rating, and ADVENTIST is the only applicant that proposes to add nursing home beds to a facility that currently has a superior licensure rating. In comparison, ADVENTIST best meets this factor, and LIFE CARE least meets this factor. Section 408.035(1)(e): Probable economies and improvements in service that may be derived from operation of joint, cooperative, or shared health care resources. ADVENTIST and RHA both have specific proposals to work with, and share services with acute care hospitals. Both are in close proximity to acute care hospitals which will expedite sharing of medical resources. RHA will also share dietary services with Princeton Hospital. The freestanding facilities proposed by HCR and LIFE CARE do not have this advantage. Section 408.035(1)(f): The need in the service district for special equipment and services which are not reasonably and economically accessible in adjoining areas. This factor is inapplicable to the proposals. No specific need was established as to special services and equipment not reasonably and economically accessible in adjoining areas. There are dedicated Alzheimer's units and dementia services for persons in adjoining areas. Section 408.035(1)(g): The need for research and educational facilities, including but not limited to, institutional training programs and community training programs for health care practitioners. RHA has an extensive proposal for the participation and training of health care practitioners in conjunction with Princeton Hospital and best meets this criterion. RHA's affiliation with the University of Florida College of Medicine, Shands Hospital, and the Brain Institute at the University of Florida enhances this proposal. ADVENTIST shares a similar educational and training relationship with Florida Hospital, and with Florida Hospital's registered nurse baccalaureate degree program through Southern College. LIFE CARE proposes to establish relationships with local community colleges and education centers to sponsor nursing programs. Section 408.035(1)(h): The availability of resources, including health manpower, management personnel, and funds for capital and operating expenditures for project accomplishment As stipulated, each applicant meets this criterion. Each applicant also has substantial personnel and management resources available for project accomplishment. Section 408.035(1)(i): The immediate and long- term financial feasibility of the proposal. LIFE CARE, ADVENTIST and RHA meet this criterion, and reasonably project positive cash flows by the second year of operation. RHA a not-for- profit corporation, projects a net loss of $114,000 in Year 1 of operation, and an excess of revenues over expenses of $53,000 in Year 2 of operation. LIFE CARE projects a net loss of $440,496 in Year 1 and a net gain of $145,085 in Year 2 for the 98-bed facility, and a net loss of $259,971 in Year 1 and a net gain of $54,920 in Year 2 for the 60-bed facility. HCR projects an after-tax profit of $25,000 in Year 2; however, in order to attain a level of profitability HCR must meet its projected 65 percent private pay utilization. This is a very high private payor mix, and there is a significant question as to whether this payor mix is attainable in the subdistrict; however, as proposed, HCR meets this factor. Sections 408.035(1)(k)(l) and (m): Impact of the project on cost of health services; cost effective- ness; construction costs. ADVENTIST proposes the most cost-effective project by adding beds to an existing facility (SLC). The addition of 38 beds to SLC will promote and maximize the overall efficiency of the facility which was originally designed with core support features to accommodate 120 residents. The proposed 38-bed addition to SLC will also lower the costs per patient day of the entire facility. The ADVENTIST proposal adds nursing home beds at the lowest per bed cost ($36,000 per bed) of all applicants. Similarly, RHA is located on the campus of an existing acute care hospital owned by the applicant and, unlike HCR and LIFE CARE, projects no actual cash expenditure for land acquisition. Each applicant has proposed a reasonable design of its proposed facility and reasonable construction costs, and taken into consideration applicable costs and methods of energy provision and conservation. Each applicant meets this criterion. Each applicant has also proposed a very high quality of care facility that will foster competition and promote quality assurance and cost- effectiveness. Each applicant meets this criterion. Section 408.035(1)(n): The applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent. RHA, ADVENTIST and LIFE CARE have proposed providing health care services to Medicaid patients at rates at, or in excess of, the district average. HCR proposes the lowest Medicaid service rate at 30 percent. RHA also has a strong record of providing Medicaid services and service to the medically indigent at Princeton Hospital. All applicants except HCR meet this factor. Section 408.035(1)(o): The applicant's past and proposed provision of services which promote a continuum of care in a multilevel health care system. The RHA and ADVENTIST proposals best meet this criterion. Both the RHA and the ADVENTIST proposals are closely associated with existing hospitals, and emphasize a continuum of care from the acute hospital setting to a nursing home facility. The RHA and ADVENTIST proposals promote the interaction of health care professionals in a multilevel health care system. The HCR and LIFE CARE proposals do not reflect such an extensive interconnection with other aspects of the health care system, and do not promote a continuum of care to the extent proposed by RHA and ADVENTIST. Section 408.035(2)(b): Whether existing inpatient facilities providing inpatient services similar to those being proposed are being used in an appropriate and efficient manner. The evidence reflects that the existing inpatient facilities in, or adjacent to, the district which offer subacute and AIDS services, as well as services dedicated to the care and treatment of persons suffering from Alzheimer's disease and related dementias are operating at, or near, capacity, and are being used in an appropriate and efficient manner.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: RHA's application for CON No. 7538 be APPROVED. ADVENTIST'S application for CON No. 7528 be APPROVED. HCR's application for CON No. 7530 be DENIED. LIFE CARE'S applications for CON Nos. 7534 and 7534P be DENIED. RECOMMENDED in Tallahassee, Leon County, Florida, this 27th day of July, 1995. RICHARD HIXSON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1995. APPENDIX HCR's Proposed Findings 1-5. Accepted in substance. 6. Rejected, insofar as quantification of need for subacute services, while not readily ascertainable, was demonstrated by other applicants.demonstrated need existed in district 7-8. Accepted in substance. 9. See Number 6. 10-14. Accepted in substance, but disposed of by ruling in Clay County case. 15-27. Accepted in substance. 28-36. Rejected insofar as quantification of need for subacute services is not readily accessible; however, need for such services was established. Accepted, except that need for 120 beds has been met. Accepted, except that RHA proposes specific pediatric services and is entitled to preference. Accepted in substance, except last sentence is rejected. Accepted. Accepted, except that ADVENTIST meets preference as to the non- subacute unit. 42-43. Accepted in substance. 44-45. Rejected. Accepted in substance. Accepted, except that ADVENTIST and RHA also meet this factor, and ADVENTIST is adding beds to an existing superior-rated facility. 48-50. Accepted in part, other applicants meet these factors. 51-65. Accepted in substance; however other services are also needed in the district. 66-67. Rejected. 68-73. Accepted in substance. 74-76. Accepted; however other services are also needed in the district. 77. Rejected. 78-86. Accepted in substance. 87-94. Accepted only to the extent that the HCR proposal meets the minimum requirements to demonstrate financial feasibility. 95-103. Accepted in substance; however each applicant's proposal also meets this factor. 104-112. Accepted in substance. 113. Rejected. 114. Accepted; however RHA proposes a minor change to correct this design. 115-116. Accepted only as to RHA design features. 117-122. Rejected. 123-127. Accepted in substance. 128-131. Rejected. LIFE CARE's Proposed Findings 1-3. Accepted in substance. 4. Accepted, except that district plan includes consideration of pediatric population. 5-7. Accepted; however other applicants also meet these factors. See Finding No. 4. Rejected to the extent that it is not uncommon for pediatric care to be provided in a nursing home setting. 10-38. Accepted in substance. 39-40. Rejected to the extent that RHA and ADVENTIST have competitive staff salaries and have experienced no difficulty in hiring qualified staff. 41-57. Accepted in substance. 58-59. Rejected. Accepted; however RHA proposes a minor change to correct this design. Rejected. 62-65. Accepted in substance. 66-69. Disposed of by Clay County case. Accepted; however ADVENTIST meets this factor in the non-subacute unit. Accepted in substance. ADVENTIST's Proposed Findings 1-4. Accepted in substance. 5. Accepted only to the extent that HCR does not propose a specific subacute care unit. 6-13. Accepted in substance. Rejected to the extent that HCR's proposal meets minimum financial feasibility requirements. Accepted. 16-17. Rejected. Accepted. Accepted to the extent that RHA and ADVENTIST best meet this criterion. 20-21. Accepted in substance. 22-26. Disposed of by Clay County case. 27-29. Accepted in substance 30-31. Rejected. 32-35. Accepted in substance. 36. Rejected; see No. 19. 37-106. Accepted in substance. 107. Accepted; see No. 19. RHA's Proposed Findings 1-21. Accepted in substance. 22. Accepted; however other applicants also meet these factors. 23-54. Accepted in substance. 55. Accepted to the extent that there are at least seven nursing homes with dedicated Alzheimer's units in or near the service area. 56-92. Accepted in substance. 93-96. Accepted; however HCR meets minimum financial feasibility requirements. 97-102. Accepted; however LIFE CARE meets minimum financial feasibility requirements. 103. Rejected. 104-122. Accepted in substance. 123. Rejected. 124-135. Accepted in substance. 136. Rejected to the extent that all applicants have met the design criterion. 137-140. Accepted in substance. 141. Rejected. 142-145. Accepted in substance. 146. Accepted to the extent that RHA and ADVENTIST best meet this criterion. COPIES FURNISHED: Stephen K. Boone, Esquire BOONE, BOONE & BOONE, P.A. Post Office Box 1596 Venice, Florida 34284 Alfred W. Clark, Esquire 117 South Gadsden, Suite 201 Tallahassee, Florida. 32301 R. Bruce McKibben, Jr., Esquire PENNINGTON & HABEN, P.A. 215 South Monroe Street, 2nd Floor Post Office Box 10095 Tallahassee, Florida 32301 Michael J. Glazer, Esquire MACFARLANE, AUSLEY, FERGUSON & MCMULLEN, P.A. Post Office Box 391 Tallahassee, Florida 32301 Samuel Dean Bunton, Esquire Senior Attorney, AHCA Atrium Building, Suite 301 325 John Knox Road Tallahassee, Florida 32303-4131 Steven R. Bechtel, Esquire MATEER, HARBERT & BATES, P.A. Post Office Box 2854 Orlando, Florida 32802 James M. Barclay, Esquire COBB, C0LE & BELL 131 North Gadsden Street Tallahassee, Florida 32301
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
Conclusions Having reviewed the Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part II, and Chapter 400, Part X, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The parties have since entered into the attached Settlement Agreement, (Ex. 2). Based upon the foregoing, it is ORDERED: 1. The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The facility’s Certificate of Exemption is deemed surrendered and is cancelled and of no further effect. 3. Each party shall bear its own costs and attorney’s fees. Any requests for administrative hearings are dismissed and the above-styled case is hereby closed. 4. In accordance with Florida law, the Respondent is responsible for retaining and appropriately distributing all client records within the timeframes prescribed in the authorizing statutes and applicable administrative code provisions. The Respondent is advised of Section 408.810, Florida Statutes. 5. In accordance with Florida law, the Respondent is responsible for any refunds that may have to be made to the clients. Filed December 24, 2014 3:10 PM Division of Aadniinistrative Hearings 6. The Respondent is given notice of Florida law regarding unlicensed activity. The Respondent is advised of Section 408.804 and Section 408.812, Florida Statutes. The Respondent should also consult the applicable authorizing statutes and administrative code provisions. The Respondent is notified that the cancellation of an Agency license may have ramifications potentially affecting accrediting, third party billing including but not limited to the Florida Medicaid program, and private contracts. ORDERED at Tallahassee, Florida, on this 7D day of Le cop ple-en 2014. MOS where Elizabeth Dudek, Secretary Agency for Health Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and core oes Final es was served on the below-named persons by the method designated on this LE lay of Z 2 Ly , 2014. Richard J. Sax Agency Cler Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 Jan Mills Thomas Jones, Unit Manager Facilities Intake Unit Licensure Unit Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Katrina Derico-Harris Arlene Mayo—Davis, Field Office Manager Medicaid Accounts Receivable Local Field Office Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Shawn McCauley Daniel A. Johnson, Senior Attorney Medicaid Contract Management Office of the General Counsel Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Division of Administrative Hearings Dagmar Llaudy, Esquire (Electronic Mail) Law Office of Dagmar Llaudy, P.A. 814 Ponce De Leon Blvd, Suite 513 Coral Gables, Florida 33134 (U.S. Mail) NOTICE OF FLORIDA LAW 408.804 License required; display.-- (1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency a license authorizing the provision of such services or the operation or maintenance of such provider. (2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued. 408.812 Unlicensed activity. -- (1) A person or entity may not offer or advertise services that require licensure as defined by this part, authorizing statutes, or applicable rules to the public without obtaining a valid license from the agency. A licenseholder may not advertise or hold out to the public that he or she holds a license for other than that for which he or she actually holds the license. (2) The operation or maintenance of an unlicensed provider or the performance of any services that require licensure without proper licensure is a violation of this part and authorizing statutes. Unlicensed activity constitutes harm that materially affects the health, safety, and welfare of clients. The agency or any state attorney may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of the unlicensed provider or the performance of any services in violation of this part and authorizing statutes, until compliance with this part, authorizing statutes, and agency rules has been demonstrated to the satisfaction of the agency. (3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense. (4) Any person or entity that fails to cease operation after agency notification may be fined $1,000 for each day of noncompliance. (5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s. 408.814 and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation. (6) In addition to granting injunctive relief pursuant to subsection (2), if the agency determines that a person or entity is operating or maintaining a provider without obtaining a license and determines that a condition exists that poses a threat to the health, safety, or welfare of a client of the provider, the person or entity is subject to the same actions and fines imposed against a licensee as specified in this part, authorizing statutes, and agency rules. (7) Any person aware of the operation of an unlicensed provider must report that provider to the agency. STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. AHCA No.: 2014008789 Exemption No.: HCC10956 MAGIC HANDS REHABILITATION CENTER, INC., Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW, the Petitioner, State of Florida, Agency for Health Care Administration (“the Agency”), by and through its undersigned counsel, and files this Administrative Complaint ‘ against the Respondent, Magic Hands Rehabilitation Center, Inc. (“the Respondent”), pursuant to Section 120.569 and 120.57, Florida Statutes (2014), and alleges: NATURE OF THE ACTION This is an action to revoke the Respondent’s health care clinic Certificate of Exemption. PARTIES 1. The Agency is the state agency that oversees the licensure and regulation of _ health care clinics in Florida pursuant to Chapters 408, Part Il, and 400, Part X, Florida Statutes (2014); and Chapter 59A-33, Florida Administrative Code. “The Legislature finds that the regulation of health care clinics must be strengthened to prevent significant cost and harm to consumers. The purpose of this part is to provide for the licensure, establishment, and enforcement of basic standards for health care clinics and to provide administrative oversight by the Agency for Health Care Administration.” § 400.990(2), Fla. Stat. (2014). 2. The Respondent applied for and was issued a Certificate of Exemption to operate a health care clinic located at 7392 NW 35" Terrace, Unit 310, Miami, Florida 33122. FYHIRIT 1 Certificate of Exemption from Licensure for Health Care Clinics 3. Under Florida law, “clinic” means an entity where health care services are provided to individuals and which tenders charges for reimbursement for such services, including a mobile clinic and a portable equipment provider. Fla. Stat. § 400.9905(4) (2014). 4. Under Florida law, the term “clinic” does not apply to a sole proprietorship, group practice, partnership, or corporation that provides health care services by licensed health care practitioners under chapter 457, chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, chapter 490, chapter 491, or part I, part III, part X, part XIII, or part XIV of chapter 468, or s. 464.012, and that is wholly owned by one or more licensed health care practitioners, or the licensed health care practitioners set forth in this paragraph and the spouse, parent, child, or sibling of a licensed health care practitioner if one of the owners who is a licensed health care practitioner is supervising the business activities and is legally responsible for the entity's compliance with all federal and state laws. However, a health care practitioner may not supervise services beyond the scope of the practitioner's license, except that, for the purposes of this part, a clinic owned bya licensee in s. 456.053(3)(b) which provides only services authorized pursuant to s. 456.053(3)(b) may be supervised by a licensee specified in s. 456.053(3)(b). Fla. Stat. § 400.9905(4)(g) (2014). Such an entity may claim to be exempt from licensure and may be eligible for a Certificate of Exemption from the Agency. 5. Under Florida law, a facility becomes a “clinic” when it does not qualify for an exemption, provides health care services to individuals and bills third party payers for those services. F.A.C. 59A-33.006(4). Facts 6. On December 19, 2013, Respondent was issued a Certificate of Exemption from licensure, number HCC10956, based upon Respondent identifying itself as solely owned by 2 Peter J. Maffetone, a licensed health care practitioner. 7. On August 22, 2014, Peter J. Maffetone gave testimony during a recorded sworn statement. 8. On that date, under oath, Peter J. Maffetone testified that he does not now, nor has he ever owned or had a financial interest in Respondent, Magic Hands Rehabilitation Center, Inc. 9. Respondent does not qualify for a Certificate of Exemption due to the fact that Peter J. Maffetone does not possess ownership. Sanction 10. Under Florida Law, any person or entity providing health care services which is not a clinic, as defined under Section 400.9905, may voluntarily apply for a certificate of exemption from licensure under its exempt status with the agency on a form that sets forth its name or names and addresses, a statement of the reasons why it cannot be defined as a clinic, and other information deemed necessary by the agency. § 400.9935(6), Fla. Stat. (2014). 11, Under Florida Law, the applicant for a certificate of exemption must affirm, without reservation, the exemption sought pursuant to Section 400.9905(4), F.S., and the qualifying requirements for obtaining and maintaining an exempt status; the current existence of applicable exemption-qualifying health care practitioner licenses; qualified ownership, qualified certifications or registration of the facility or owners; federal employer identification number; services provided; proof of legal existence and fictitious name, when the entity and name are required to be filed with the Division of Corporations, Department of State; plus other satisfactory proof required by form adopted by this rule. F.A.C. 59A-33.006(6). 12. Under Florida Law, facilities that claim an exemption, either by filing an application for a certificate of exemption with the Agency and receiving a certificate of exemption, or self-determining, must maintain an exempt status at all times the facility is in operation. F.A.C. 59A-33.006(2). 13. Under Florida Law, when a change to the exempt status occurs to an exempt facility or entity that causes it to no longer qualify for an exemption, any exempt status claimed or reflected in a certificate of exemption ceases on the date the facility or entity no longer qualifies for a certificate of exemption. In such case, the health care clinic must file with the Agency a license application under the Act within 5 days of becoming a health care clinic and shall be subject to all provisions of the Act applicable to unlicensed health care clinics. Failure to timely file an application for licensure within 5 days of becoming a health care clinic will render the health care clinic unlicensed and subject the owners, medical or clinic directors and the health care clinic to sanctions under the Act. F.A.C. 59A-33.006(3). 14. As demonstrated by the facts outlined herein, Respondent no longer qualifies for a Certificate of Exemption pursuant to § 400.9905(4)(g), Fla. Stat. (2014). 15. Therefore, Respondent is now required to be licensed as a clinic pursuant to F.A.C. 59A-33.006 and Chapters 408, Part II, and 400, Part X, Fla. Stat, 16. Under Section 400.995, Florida Statutes, in addition to the requirements of Part II of Chapter 408, the Agency may deny the application for a license renewal, revoke and suspend the license, and impose administrative fines of up to $5,000 per violation for violations of the requirements of this part or rules of the agency. § 400.995(1), Fla. Stat. (2014). Each day of continuing violation after the date fixed for termination of the violation, as ordered by the agency, constitutes an additional, separate, and distinct violation. § 400.995(2), Fla. Stat. (2014). 17. Under Section 400.9915(2), Florida Statutes, in addition to any administrative fines imposed pursuant to this part or Part IT of Chapter 408, the Agency may assess a fee equal to the cost of conducting a complaint investigation. § 400.9915(2), Fla. Stat. (2014). WHEREFORE, the Agency seeks to revoke the Respondent's health care clinic Certificate of Exemption. CLAIM FOR RELIEF The Petitioner, State of Florida, Agency for Health Care Administration, respectfully seeks a final order that: A. Makes findings of fact and conclusions of law in favor of the Agency as set forth above. B. Imposing the sanctions and relief as set forth above. Gj RESPECTFULLY SUBMITTED on this / / day of September, 2014. Florida Bar No. 0091175 Office pt the General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 Telephone: (850) 412-3658 Facsimile: (850) 922-6484 Daniel. Johnson@ahca.myflorida.com
Findings Of Fact The PROVIDER received the FAR that gave notice of PROVIDER'S right to an administrative hearing regarding the fine. The PROVIDER filed a petition requesting an administrative hearing, and the administrative hearing case was CLOSED. PROVIDER chose not to dispute the facts set forth in the Final Agency Audit Report dated June 12, 2006. The facts alleged in the FAR are hereby deemed admitted. The Agency hereby adopts the facts as set forth in the FAR, including the fine amount of $2,000.00, the requirement to complete a corrective action plan in the form of provider education, and repayment of the $72,202.51 overpayment and payment of a $2,000.00 fine. The Petitioner entered into a payment Plan Agreement with the Agency on August 13, 2007.
Conclusions THIS CAUSE came before me for issuance of a Final Order on a Final Audit Report ("FAR") dated June 12, 2006 (C.I. No. 06-4078-000). By the Final Audit Report, the Agency for Health Care Administration ("ARCA" or "Agency"), informed the Petitioner, The Pediatric Center, Inc., (hereinafter "PROVIDER"), that the Agency was seeking to recover overpayments in the amount of $72,202.51, a fine. sanction of $2,000.00 pursuant to Sections 409.913(15), (16), and (17), Florida Statutes, and Rule 590-9.070, Florida Administrative Code and a Corrective Action Plan in the form of provider education. The Final Audit Report provided full disclosure and notice to the PROVIDER of procedures for requesting an administrative hearing to contest the sanction. The PROVIDER filed a petition with the Agency requesting a formal administrative hearing on or about June 12, 2006. The Agency forwarded PROVIDER'S hearing request to the Division of Administrative Hearings ("DOAH") for a formal administrative hearing. DOAH closed its file and relinquished jurisdiction to ARCA on October 2, 2006. Page 1 of5 Filed January 11, 2010 4:24 PM Division of Administrative Hearings.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: East Pasco Medical Center (EPMC) is a non-profit 85-bed acute care hospital facility located in the East Pasco subdistrict of HRS District V. There are only two hospitals in the subdistrict -- EPMC in Zephyrhills and Humana in Dade City, which is approximately ten miles north. Humana is a 120- bed acute care hospital facility. Both facilities offer the same services and share the same medical staff. On or about September 17, 1987, EPMC submitted an application for a Certificate of Need to add 35 medical/surgical beds via a fourth floor addition to its existing facility. Its existing 85 beds are located in private rooms, and it is proposed that the additional 35 beds will also be placed in separate rooms. The application submitted to the Department of Health and Rehabilitative Services (HRS) projected a total project cost of $4,531,000. This figure was revised at the hearing to a project cost of $2,302,900. With regard to acute care services, the State Health Plan seeks to assure geographic accessibility. All residents of East Pasco County currently have access to acute care hospital services within the travel times suggested by the State plan. The State Health Plan also seeks to promote the efficient utilization of acute care services by attaining an average annual occupancy rate of at least 80 percent. The District V Local Health Plan emphasizes that additions to inpatient acute care beds in a subdistrict should not be considered unless a numeric bed need is shown and certain occupancy thresholds have been met. The recommended occupancy thresholds for medical/surgical beds are 80% for the subdistrict and 90% for the facility seeking to add beds. Application of the bed need methodology contained in HRS's Rule 10- 5.011(1)(m), Florida Administrative Code, indicates a numeric need for 57 additional acute care medical/surgical beds in the East Pasco subdistrict for the planning horizon period of July, 1992. The rule provides that HRS will "not normally approve" additional beds unless average occupancy in the subdistrict is greater than 75 percent. However, the rule permits HRS to award additional beds when there is a calculated need, notwithstanding low occupancy in the subdistrict, if the applicant had a minimum of 75% average occupancy during the 12 months ending 14 months prior to the Letter of Intent. Rule 10- 5.011(1)(m)7.e., Florida Administrative Code. The rule also permits HRS to award additional beds where the calculated numeric need substantially exceeds the number of existing and approved beds in the subdistrict and there is an access problem related to travel time. For the relevant time period, the acute care occupancy rate for the East Pasco subdistrict was below 75% percent. Indeed, over the past few years, the average occupancy rate in that subdistrict has been 54 to 58 percent. Humana only operates at about a 55% occupancy. The East Pasco subdistrict does experience seasonal fluctuations in medical/surgical occupancy, with the season for high occupancy beginning in late October and ending in mid- to late April. In addition to tourists, it is expected that the revival of the citrus industry in East Pasco County will bring more migrant pickers to the area during the peak season months. The seasonal increase in occupancy directly corresponds with a large increase in seasonal population, particularly in the Zephyrhills area. The Zephyrhills area population is much older than the Dade City population and is also much older than the State average. The HRS acute care bed need rule includes considerations of seasonal peak demands. When considering both hospitals in the subdistrict, there has been a decline in peak seasonal occupancy rates over the past few years. While the population of the East Pasco subdistrict has grown, and is expected to increase by approximately 7,200 in 1992, there is a trend of declining utilization in the subdistrict. This decline is due to increased used of outpatient services and shorter lengths of hospital stay attributable to the current reimbursement system. The medical/surgical use rate fell from 454 patient days per 1,000 population in 1986 to 414 patient days per 1,000 population in 1988. There was a similar decline in the acute care use rate. Assuming a constant medical/surgical use rate, the projected demand for 1992 would be 2,980 additional medical/surgical patient days in the subdistrict according to population projections, and about 4,267 incremental patient days according to local health council projections. EPMC's Letter of Intent to add 35 additional beds was filed in mid- July, 1987. Its acute care occupancy rate for the period of April, 1986 through March, 1987 was 75.3 percent. Occupancy at EPMC from May, 1986 to April, 1987 was 73.6%; occupancy from June, 1986 through May, 1987 was 73%; and occupancy from July, 1986 to June, 1987 was 72.2 percent. EPMC does experience periods of high occupancy during the peak season months. High occupancy levels have a greater impact upon smaller hospitals due to their lesser degree of flexibility. On occasion, during the winter months, EPNC is required to refuse admittance to patients due to crowded conditions within its facility. Patients are sometimes transferred or referred to other facilities, including Humana, although the necessity for such transfers or referrals is occasionally due to a lack of intensive or critical care beds as opposed to a lack of medical/surgical beds. During the periods of time when EPMC had high occupancy levels, beds were available at Humana. EPMC's current payor mix includes a high level of Medicare (over 60%), and it is committed, through both its Christian mission and an agreement with the County, to treat indigent and Medicaid patients. The actual amount of indigent or charity care provided by EPNC was not established. In any event, EPMC desires to increase its bed size in order to help maintain a proper payor mix at the hospital so as to ensure the financial survival of the hospital. It is felt that a greater number of beds, given the rise in population, and particularly elderly population, would allow EPNC to serve a greater number of private and/or third party insurance paying patients. While the evidence demonstrates that EPMC may operate with a less favorable payor mix than Humana, the evidence was not sufficient to demonstrate that EPMC will suffer financial ruin without additional beds. Likewise, it was not established that the patients which EPNC must turn away in the winter months are consistently paying patients. Increasing the number of beds at EPNC to 120 beds does not necessarily mean that its profitability would be improved. Volume and payor mix are the most critical factors in determining whether a hospital will be profitable. There is currently a nursing shortage throughout the nation. Rural areas, such as the eastern portion of Pasco County, experience even greater difficulty in attracting nursing personnel to the area. Due to the shortage of nurses, as well as the seasonal demand, EPMC is required to use contract care nurses throughout the year. While it would prefer to employ its own nursing staff, EPMC will use contract staff due to the seasonal variations in its nursing requirements. The use of contract or registry nurses costs 50% to 60% more on a daily basis; however, lower occupancy during the off-peak months does not justify year- round employment for as large an in-house nursing staff. For its proposed 35 beds, EPMC projects nurse manpower requirements as follows: 1 nurse manager, 4.2 R.N. charge nurses, 15.1 R.N. staff and 14.1 L.P.N. staff, for a total of 34.4 full time equivalent nursing positions. The recruiting efforts of EPNC to fill these positions will include advertising, visiting nursing schools and colleges, utilizing student nurses at the hospital and use of the Adventist Health System international network. Humana currently has 15 vacancies, or 12 to 13% of its nursing staff. Humana's nursing salaries have increased 20% over the past eighteen months. As noted above, EPNC and Humana compete for the same nursing personnel. Humana's personnel director believes that if EPNC increases its nursing staff by 34 FTEs, Humana's nursing staff will be approached to fill those positions. As a consequence, Humana will experience additional nursing shortages and will be required to further increase salaries. It is proposed that the project cost of adding 35 beds to EPMC will be financed with 100% debt financing through a bond issue. The financing will be part of a much larger bond issuance intended to finance several other projects within the Adventist hospital system. No evidence was adduced that such a bond issuance had been prepared or approved, and there was no evidence concerning the other projects which would be financed in conjunction with this project. In 1987, EPNC was carrying about five million dollars of negative equity. The hospital is currently greater than 100% financed. As noted above, the original Certificate of Need application filed with HRS listed the total project cost to be $4,531,000. In its response to omissions, EPMC stated that the construction cost would be $175 per square foot. In the updates submitted at the hearing, EPNC proposed a project cost of $2,302,900, which included a construction cost of $85 per square foot. A more reasonable cost for the addition of a floor to an existing facility would be $125 per square foot, plus an inflation factor of 6% and architectural and engineering fees of 6 to 7%. The proposed equipment list submitted by EPNC fails to include major equipment items such as an overhead paging system, a nurse call system, examination room equipment, medication distribution equipment, bed curtains, shower curtains, patient and staff support lounge items, and IV pumps. EPNC's updated equipment cost budget fails to include tax, freight, contingency and installation costs. The projected equipment costs should be tripled to adequately and reasonably equip a 35-bed nursing unit. The projected utilization and pro formas submitted by EPMC are not reasonable and were not supported by competent substantial evidence. EPMC's projected utilization for the proposed 35-bed unit is 8,950 patient days in the first year of operation and 9,580 in the second year of operation. Applying the current use rate to the population projections submitted by EPMC's expert in demographics and population projections produces only about 2,980 additional patient days in the year 1992. Given the fact that EPMC's current market share is approximately 54%, there is no reason to believe that Humana would not absorb at least some of those projected additional patient days. There are many months of the year in which additional patient days could be filled within the existing complement of 85 beds at EPNC. Depending upon the ultimate cost of the project, the break even point for financial feasibility purposes would be approximately 3,500 to 4,000 patient days. The concept behind a pro forma is to develop a financial picture of what operations will be in the first two years of operation. EPMC stated its revenues and expenses in terms of 1988 dollars and used its current revenue- to-expense ratios for projecting operations four years into the future. This is improper because gross revenues are going up, reimbursement is not increasing as rapidly and expenses, particularly salaries and insurance, are increasing. In addition, EPMC's projected 1992 salaries in several categories were less than they are currently paying for such positions. EPMC currently provides good quality of care to its patients. The only future concern in this realm is the fact that in the winter months, its intensive and critical care unit beds are often full and there is no room for additional patients. Additional medical/surgical volume from the proposed 35- bed unit would lead to additional intensive and critical care bed demand.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that the application of East Pasco Medical Center for a Certificate of Need to add 35 acute care beds to its existing facility be DENIED. Respectfully submitted and entered this 30 day of March, 1989, in Tallahassee, Florida. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of March, 1989. APPENDIX TO RECOMMENDED ORDER CASE NO. (Case No. 88-1227) The proposed findings of fact submitted by the parties have been carefully considered and are accepted, incorporated and/or summarized in this Recommended Order, with the following exceptions: Petitioner: Third sentence rejected as not established by competent, substantial evidence. Accepted, but not included as irrelevant to the ultimate resolution of the issues. Rejected. The Personnel Director of Humana presented testimony in this proceeding. Accepted as an accurate restatement of testimony, but rejected as an erroneous conclusion of law. 16. Second sentence rejected as an erroneous conclusion of law. A18. Rejected as contrary to the evidence. 20. First sentence rejected as an erroneous conclusion of law. First sentence rejected as an erroneous conclusion of law. Rejected as not supported by competent substantial evidence. 27 and 30. Accepted as an accurate restatement of testimony, but rejected as an erroneous conclusion of law. Rejected as immaterial to the issue of need in the year 1992. First sentence rejected as not established by competent substantial evidence. First and third sentences rejected as not established by competent substantial evidence. 37 and 38. Rejected as not established by competent substantial evidence. 44. Last sentence rejected as unsupported by competent substantial evidence. Accepted only if the factors of volume and payor mix are also considered. Partially rejected as speculative and not supported by competent substantial evidence. All but first two sentences rejected as unsupported by competent substantial evidence and an erroneous conclusion of law. Rejected as unsupported by competent substantial evidence and an erroneous conclusion of law. Last sentence rejected as unsupported by the evidence. Rejected as unsupported by competent substantial evidence. Second sentence rejected as contrary to the greater weight of the evidence. 58. Rejected as irrelevant and immaterial. 60. Rejected as not established by competent substantial evidence. 62 - 67. The actual figures regarding total costs, projected utilization and those figures utilized in the pro formas were not established by competent substantial evidence and, therefore, the findings regarding the financial feasibility of the project are rejected. 71. Rejected as not supported by competent substantial evidence. 74. Rejected as not supported by competent substantial evidence. 77. Rejected as an improper factual finding and contrary to the evidence. 78 and 79. Rejected as contrary to the greater weight of the evidence. First sentence rejected as unsupported by competent substantial evidence. Last sentence rejected as unsupported by the evidence. Rejected as contrary to the evidence. Respondent: 2 and 6. Partially accepted with the additional considerations of the applicant's occupancy levels and geographic accessibility. 9. Rejected as contrary to the evidence. 19(a) Interpretation of rule not sufficiently explicated at hearing. 56 - 58. Actual figures are not established by competent evidence due to the failure to establish with reliability the total costs of the project. Intervenor: Second sentence accepted with the additional considerations of the applicant's occupancy levels and geographic accessibility. Third sentence rejected. Interpretation of rule not sufficiently explicated at hearing. First sentence rejected, but this does not preclude a consideration of such a period. Third sentence rejected as not established by the greater weight of the evidence. 31. Second sentence rejected as speculative. 40 and 41. Accepted as factually correct, but not included due to the showing of unused capacity within the East Pasco subdistrict. 55 and 56. Actual figures are not established by competent evidence due to the failure to establish with reliability the total costs of the project. 63 and 72. Same as above with regard to second sentence. 92. Rejected as an overbroad statement or conclusion. 97. Second sentence rejected as overbroad and not supported by the evidence. COPIES FURNISHED: E.G. Boone and Jeffrey Boone 1001 Avenida del Circo Post Office Box 1596 Venice, Florida 34284 Stephen M. Presnell Macfarlane, Ferguson, Allison & Kelly Post Office Box 82 Tallahassee, Florida 323a2 James C. Hauser Messer, Vickers, Caparello, French & Madsen, P.A. Post Office Box 1876 Tallahassee, Florida 32302 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller, Esquire General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Conclusions Having reviewed the Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part II, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The Election of Rights form advised of the right to an administrative hearing. 3. The parties have since entered into the attached Settlement Agreement. (Ex. 2) Based upon the foregoing, it is ORDERED: 1, The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The Respondent shall pay the Agency $14,500. If full payment has been made, the cancelled check acts as receipt of payment and no further payment is required. If full payment has not been made, payment is due within 30 days of the Final Order. Overdue amounts are subject to statutory interest and may be referred to collections. A check made payable to the “Agency for Health Care Administration” and containing the AHCA ten-digit case number should be sent to: Office of Finance and Accounting Revenue Management Unit Agency for Health Care Administration 2727 Mahan Drive, MS 14 Tallahassee, Florida 32308 Filed January 28, 2014 3:22 PM Division of Admitlistrative Hearings 3. Conditional licensure status is imposed on the Respondent beginning on August 30, 2012 and ending on September 4, 2012. 4. The references in the Statement of Deficiencies for the August 28-30, 2012 survey of Springwood Care and Rehabilitation Center relating to Resident #2 being on thickened liquids is deleted. ORDERED at Tallahassee, Florida, on this 2-4 day of eee , 2014. i Le ek, Secretary y for Nealfh Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and correct opt this Final Order was served on the below-named persons by the method designated on this ZY. ay of eauary , 2014. Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 Jan Mills Finance & Accounting Facilities Intake Unit Revenue Management Unit (Electronic Mail) (Electronic Mail) Andrea M. Lang Thomas W. Caufman, Esq. Office of the General Counsel Quitairos, Prieto, Wood & Boyer, P.A. Agency for Health Care Administration Attorney for Respondent (Electronic Mail) 4905 West Laurel Street, 2"! Floor Tampa, Florida 33607 (U.S. Mail) Lynne A. Quimby-Pennock Administrative Law Judge Division of Administrative Hearings (Electronic Mail) STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case Nos. 2012009469 4602 NORTHGATE COURT, LLC d/b/a SPRINGWOOD CARE AND REHABILITATION CENTER, Respondent. / ADMINISTRATIVE COMPLAINT. COMES NOW the Agency for Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against 4602 NORTHGATE COURT, LLC d/b/a SPRINGWOOD CARE AND REHABILITATION CENTER (hereinafter “Respondent”), pursuant to Sections 120.569 and 120.57 Florida Statutes (2012), and alleges: NATURE OF THE ACTION This is an action against a nursing home to impose an administrative fine of TEN THOUSAND DOLLARS ($10,000.00) pursuant to Section 400.23(8)(a), Florida Statutes (2012), based upon one (1) Class I deficiency; to assess a survey fee in the amount of SIX THOUSAND DOLLARS ($6,000.00) based upon Respondent being cited for one (1) Class I deficiency pursuant to Section 400.19(3), Florida Statutes (2012), and to assign conditional licensure status beginning on August 30, 2012, pursuant to Section 400.23(7)(b), Florida Statutes (2012). The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. EXHIBIT 1 JURISDICTION AND VENUE 1. The Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2012). 2. The Agency has jurisdiction over the Respondent pursuant to Section 20.42, Chapter 120, and Chapter 400, Part II, Florida Statutes (2012). 3. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code. PARTIES 4. The Agency is the regulatory authority responsible for the licensure of nursing homes and the enforcement of all applicable federal and state statutes, regulations and rules governing nursing homes pursuant to Chapter 400, Part Il, Florida Statutes (2012) and Chapter 59A-4, Florida Administrative Code. The Agency is authorized to deny, suspend, or revoke a license, and impose administrative fines pursuant to Sections 400.121 and 400.23, Florida Statutes (2012); assign a conditional license pursuant to Section 400.23(7), Florida Statutes (2012); and assess costs related to the investigation and prosecution of this case pursuant to Section 400.121, Florida Statutes (2012). 5. Respondent operates a 120-bed nursing home, located at 4602 Northgate Court, Sarasota, Florida 34234, and is licensed as a nursing home, license number 15130962. Respondent was at all times material hereto, a licensed nursing home under the licensing authority of the Agency, and was required to comply with all applicable state rules, regulations and statutes. COUNTI The Respondent Failed To Ensure Residents The Right To Receive Adequate And Appropriate Protective And Support Services In Violation Of Section 400.022(1)(), Florida Statutes (2012) 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7. Pursuant to Florida law, all licensees of nursing home facilities shall adopt and make public a statement of the rights and responsibilities of the residents of such facilities and shall treat such residents in accordance with the provisions of that statement. The statement shall assure each resident the following: The right to receive adequate and appropriate health care and protective and support services, including social services; mental health services, if available; planned recreational activities; and therapeutic and rehabilitative services consistent with the resident care plan, with established and recognized practice standards within the community, and with rules as adopted by the Agency. Section 400.022(1)(1), Florida Statutes (2012). 8. On or about August 28, 2012 through August 30, 2012, the Agency conducted a Complaint Investigation (CCR# 2012009348 and CCR# 2012008938) of the Respondent’s facility. 9. Based on record review, interview and observation, the facility failed to prevent the abuse, neglect and mistreatment of one (1) of three (3) sampled residents, specifically Resident number two (2). This resulted from the willful spraying of water in the facial area of Resident number two (2), who had an order to receive only thickened liquids, palliative care and was known to be resistive to activities of daily living, including showering. The facility's failure with Resident number two (2) and their failure to identify the need to retrain staff on procedures to appropriately shower residents with similar conditions placed all residents with those conditions at risk for serious injury, harm, impairment, or death. 10. On August 28, 2012, a review of Resident number two’s (2) record containing a Nursing Progress note dated August 25, 2012 at 5:30 a.m. which documented, “Resident number two (2) moaning loudly (and) then screaming... Visible signs of pain on Resident’s face (fear and grimacing)." Morphine 5 mg/0.25 cc SL (11:00 p.m. and 5 a.m.) and back rubbing, both had positive calming effect. 11. The progress note also documented, "Took 80 cc of water during the night shift. Pulse 78, respirations 16; unlabored while awake, dyspnea noticed while sleeping. Resting with cycs closed. Will monitor." 12. A nursing note at 12:20 p.m. documented MS04 (Morphine Sulfate) 0.25 cc was administered "with minimal effect" to Resident number two (2), who was "very anxious and moaning loudly." The note states at approximately 11:50 a.m., Certified Nursing Assistants called the nurse into the shower room where Resident number two (2) was found unresponsive with a faint pulse. Resident number two (2) was returned to bed immediately with a board under him/her. Cardio Pulmonary Resuscitation was administered and oxygen was placed over Resident number two’s (2) face. No pulse was felt. The paramedics arrived and continued Cardio Pulmonary Resuscitation. At 12:10 p.m., paramedics stated Resident number two (2) had passed away. The nursing note documented, the "Director of Nursing notified and family was being contacted by Director of Nursing. Westside funeral home called." 13. On August 29, 2012 at 12:45 p.m. during an interview regarding the event on August 25, 2012, Employee F stated, "I asked another Certified Nursing Assistant (Employee G) to help me give Resident number two (2) a shower." During the shower, when Employee G sprayed water in the resident's face, Employee F said, "Do not do that, he/she is on thickened liquids." Employee G said, “Resident number two (2) had soap in his/her eyes." After that, Employee F got the nurse because Resident number two (2)"was not acting normal." 14. During this interview, Employee F stated, "I am CPR certified, (but) did not assist with it." When asked when the last training on abuse was received, Employee F said, “I do the modules on the computer; | believe last month." Regarding the facility staff to notify in a case of abuse, Employee F stated, "You notify the Abuse Coordinator, the Director of Nursing, her name is on my badge." The incident was reported via phone call to Employee M, the Unit Manager, who was at home on August 25, 2012, by Employees J and F. 15. Inn interview on August 29, 2012, at 10:30 a.m., Employee M reported receiving a call at home on August 25, 2012 at approximately 1:10 p.m. regarding Resident number two (2). Employees I and F reported that while giving Resident number two (2) a shower, Employee G sprayed Resident number two (2) in the face and the mouth. Employee I did not see the action, but Employee F witnessed Employee G spray Resident number two (2). 16. During interviews on August 29, 2012, Employees B, D, N and H stated they received training about abuse after August 25, 2012. Employee H stated the instruction provided during training regarding getting shampoo out of a resident’s hair included "have them hold their head back and rinse it out." When asked if a resident had mucous coming out of their nose and going into their mouth, can you spray it off with the shower head, Employee H answered, “It is okay to spray it (face) to get it (mucous) out." 17. On August 28, 2012, a record review of Resident number two’s (2) Minimum Data Set Kardex Report for 2880 noted the resident as "Moderately Impaired" to make Activities of Daily Living, but made no mention of bathing or behavior issues. Also, there was no indication Resident number two (2) was receiving thickened liquids. The Kardex report is used by staff as a quick review of resident information. 18. On August 28, 2012, a review of the shower schedule used by the Certified Nursing Assistants, last updated on June 14, 2012 for Resident number two (2), revealed the resident due "Saturday" by the "11:00 p.m. to 7:00 a.m. shift." The shower schedule notes no change can be made without the Unit Manager’s approval. Resident number two (2) was given a shower on August 25, 2012 during the 7:00 a.m. to 3:00 p.m. shift. 19. On August 28, 2012, a review of Resident number two’s (2) Medication Administration Record dated August 25, 2012 revealed a physician order for palliative care to start on August 23, 2012. There was no indication the nursing staff knew to provide the palliative care on August 23, 2012, August 24, 2012 and August 25, 2012 as no nurse initialed those dates. 20. A record review on August 28, 2012 revealed Resident number two (2) was admitted to the facility on July 20, 2012. On August 23, 2012, Resident number two (2) was documented with a "Medical Diagnosis of Dysphasia," and was to receive "Palliative Care Only." 21. During an interview on August 29, 2012 at 2:25p.m., the administrator stated, "We are pretty much concluding with the investigation. We are unable to substantiate abuse.” 22. Regarding training provided since August 25, 2012, the administrator said, "We have done education on the Abuse and Neglect policy; what it means, how it is reported, with examples specifically of the scenario of Resident number two (2). If staff has an understanding of what abuse is, they are more aware of how they are interacting with residents. I am comfortable with what has taken place so far." During the interview, the administrator did not report any training was provided regarding the appropriateness of residents receiving showers, who are on palliative care, do not like showers, and have behavior issues." 23. \ The facility had failed to prevent abuse, neglect or the mistreatment of Resident number two (2) and other similarly-effected residents. Interviews and record reviews revealed staff failed to implement current standard of practice showering procedures with a resident that was on palliative care; had identified issues with exhibiting difficult behaviors, including while being showered and was on thickened liquids. On August 28, 2012, August 29, 2012 and August 30, 2012, the facility administrative staff failed to retrain and monitor adequately direct care staff administering showers to residents. 24. The facility has failed to ensure the critical incident will not be repeated. 25. The Agency determined that this deficient practice presented a situation in which immediate corrective action was necessary because Respondent’s non-compliance had caused, or was likely to cause, serious injury, harm, impairment, or death to a resident receiving care in Respondent's facility. The Agency cited Respondent for an isolated Class I deficiency as set forth in Section 400.23(8)(a), Florida Statutes (2012). WHEREFORE, the Agency intends to impose an administrative fine in the amount of TEN THOUSAND DOLLARS ($10,000.00) against Respondent, a nursing home in the State of Florida, pursuant to Sections 400.23(8)(a), Florida Statutes (2012). COUNT I Assignment Of Conditional Licensure Status Pursuant To Section 400.23(7)(b), Florida Statutes (2012) 26. The Agency re-alleges and incorporates by reference the allegations in Count I. 27. The Agency is authorized to assign a conditional licensure status to nursing homes pursuant to Section 400.23(7), Florida Statutes (2012). 28. Due to the presence of one (1) Class I deficiency, the Respondent was not in substantial compliance at the time of the survey with criteria established under Chapter 400, Part II, Florida Statutes (2012), or the rules adopted by the Agency. 29. The Agency assigned the Respondent conditional licensure status with an action effective date of August 30, 2012. The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the Respondent conditional licensure status for the period beginning on August 30, 2012, pursuant to Section 400.23(7)(b), Florida Statutes (2012). COUNT OI Assessment Of Fine Pursuant To Section 400.19(3), Florida Statutes (2012) 30. The Agency re-alleges and incorporates by reference the allegations in Count I and Count II. 31. The Respondent has been cited for one (1) Class I deficiency and therefore is subject to a six (6) month survey cycle for a period of two (2) years and a fine of SIX THOUSAND DOLLARS ($6,000.00) pursuant to Section 400.19(3), Florida Statutes (2012). WHEREFORE, the Agency intends to impose a six (6) month survey cycle for a period of two (2) years and assess a fine in the amount of SIX THOUSAND DOLLARS ($6,000.00) against Respondent, a nursing home in the State of Florida, pursuant to Section 400.19(3), Florida Statutes (2012). CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the following relief against the Respondent as follows: 1. Make findings of fact and conclusions of law in favor of the Agency on Count I through Count III. 2. Impose an administrative fine against the Respondent in the amount of TEN THOUSAND DOLLARS ($10,000.00) pursuant to Section 400.23(8)(a), Florida Statutes (2012), and assess a survey fee in the amount of SIX THOUSAND DOLLARS ($6,000.00), pursuant to Section 400.19(3), Florida Statutes (2012), for a total of SIXTEEN THOUSAND DOLLARS ($16,000.00). 3. Assign a conditional license to the Respondent beginning on August 30, 2012. 4. Assess costs related to the investigation and prosecution of this case. 5. Enter any other relief that this Court deems just and appropriate. Respectfully submitted this i144 day of Sewer , 2012. tug a ae Co oN, YJ wane Andrea M. Lang, Assistant General Cournsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 NOTICE RESPONDENT IS NOTIFIED THAT IT/HE/SHE HAS A RIGHT TO REQUEST AN ADMINISTRATIVE HEARING PURSUANT TO SECTIONS 120.569 AND 120.57, FLORIDA STATUTES. THE RESPONDENT IS FURTHER NOTIFIED THAT IT/HE/SHE HAS THE RIGHT TO RETAIN AND BE REPRESENTED BY AN ATTORNEY IN THIS MATTER. SPECIFIC OPTIONS FOR ADMINISTRATIVE ACTION ARE SET OUT IN THE ATTACHED ELECTION OF RIGHTS. ALL REQUESTS FOR HEARING SHALL BE MADE AND DELIVERED TO THE ATTENTION OF: THE AGENCY CLERK, AGENCY FOR HEALTH CARE ADMINISTRATION, 2727 MAHAN DRIVE, BLDG #3, MS #3, TALLAHASSEE, FLORIDA 32308; TELEPHONE (850) 412-3630. THE RESPONDENT IS FURTHER NOTIFIED THAT IF A REQUEST FOR HEARING IS NOT RECEIVED BY THE AGENCY FOR HEALTH CARE ADMINISTRATION WITHIN TWENTY-ONE (21) DAYS OF THE RECEIPT OF THIS ADMINISTRATIVE COMPLAINT, A FINAL ORDER WILL BE ENTERED BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form were served to: Corporation Service Company, Registered Agent for 4602 Northgate Court, LLC d/b/a Springwood Care and Rehabilitation Center, 1201 Hays Street, Tallahassee, Florida 32301, by United States Certified Mail, Return Receipt No. 7011 2000 0001 4884 9195 and to Susan Ritchie, Administrator, 4602 Northgate Court, LLC d/b/a Springwood Care and Rehabilitation Center, 4602 Northgate Court, Sarasota, Florida 34234, by United States Certified Mail, Return Receipt No. 7011 2000 0001 4884 9195 on this is Onis day of Segoe mbec . 2012. Qt 1M, Nowe Andrea M. Lang, Assistant General Counsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 Copies furnished to: Susan Ritchie, Administrator 4602 Northgate Court , LLC d/b/a Springwood Care and Rehabilitation Center 4602 Northgate Court Sarasota, Florida 34234 (U.S. Certified Mail) Andrea M. Lang, Assistant General Counsel Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (Electronic Mail) Corporation Service Company Registered Agent for 4602 Northgate Court, LLC d/b/a Springwood Care and Rehabilitation Center 1201 Hays Street Tallahassee, Florida 32301 (U.S. Certified Mail) Bernard Hudson, Health Services and Facilities Consultant Supervisor Bureau of Long Term Care Services Long Term Care Unit Agency for Health Care Administration 2727 Mahan Drive, Building #3, Room 1213B Tallahassee, Florida 32308 (Electronic Mail) Harold Williams Field Office Manager Agency for Health Care Administration 2295 Victoria Avenue, Room 340A Fort Myers, Florida 33901 (Electronic Mail) STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case Nos. 2012009469 4602 NORTHGATE COURT, LLC d/b/a SPRINGWOOD CARE AND REHABILITATION CENTER, Respondents. ELECTION OF RIGHTS This Election of Rights form is attached to a proposed action by the Agency for Health Care Administration (AHCA). The title may be an Administrative Complaint, Notice of Intent to Impose a Late Fee, or Notice of Intent to Impose a Late Fine. Your Election of Rights must be returned by mail or by fax within twenty-one (21) days of the date you receive the attached Administrative Complaint, Notice of Intent to Impose a Late Fee, or Notice of Intent to Impose a Late Fine. If your Election of Rights with your elected Option is not received by AHCA within twenty-one (21) days from the date you received this notice of proposed action by AHCA, you will have given up your right to contest the Agency’s proposed action and a Final Order will be issued. Please use this form unless you, your attorney or your representative prefer to reply in accordance with Chapter 120, Florida Statutes (2012) and Rule 28, Florida Administrative Code. PLEASE RETURN YOUR ELECTION OF RIGHTS TO THIS ADDRESS: Agency for Health Care Administration Attention: Agency Clerk 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 Phone: 850-412-3630 Fax: 850-921-0158 PLEASE SELECT ONLY 1 OF THESE 3 OPTIONS OPTION ONE (1) ___ I admit the allegations of fact and law contained in the Notice of Intent to Impose a Late Fine or Fee, or Administrative Complaint and I waive my right to object and to have a hearing. I understand that by giving up my right to a hearing, a Final Order will be issued that adopts the proposed agency action and imposes the penalty, fine or action. OPTION TWO (2) ___ I admit the allegations of fact and law contained in the Notice of Intent to Impose a Late Fine or Fee, or Administrative Complaint, but I wish to be heard at an informal proceeding (pursuant to Section 120.57(2), Florida Statutes) where I may submit testimony and written evidence to the Agency to show that the proposed administrative action is too severe or that the fine should be reduced. OPTION THREE (3)__ I dispute the allegations of fact and law contained in the Notice of Intent to Impose a Late Fee, the Notice of Intent to Impose a Late Fine, or Administrative Complaint, and I request a formal hearing (pursuant to Subsection 120.57(1), Florida Statutes) before an Administrative Law Judge appointed by the Division of Administrative Hearings. PLEASE NOTE: Choosing OPTION THREE (3) by itself is NOT sufficient to obtain a formal hearing. You also must file a written petition in order to obtain a formal hearing before the Division of Administrative Hearings under Section 120.57(1), Florida Statutes. It must be received by the Agency Clerk at the address above within 21 days of your receipt of this proposed administrative action. The request for formal hearing must conform to the requirements of Rule 28- 106.2015, Florida Administrative Code, which requires that it contain: 1. Your name, address, telephone number, and the name, address, and telephone number of your representative or lawyer, if any. 2. The file number of the proposed action. 3. A statement of when you received notice of the Agency’s proposed action. 4. A statement of all disputed issues of material fact. If there are none, you must state that there are none. Mediation under Section 120.573, Florida Statutes may be available in this matter if the Agency agrees. License Type: (Assisted Living Facility, Nursing Home, Medical Equipment, Other) Licensee Name: License Number: Contact Person: Name Title Address: Street and Number City State Zip Code Telephone No. Fax No. E-Mail (optional) I hereby certify that I am duly authorized to submit this Notice of Election of Rights to the Agency for Health Care Administration on behalf of the above licensee. Signature: Date: Title: Print Name: FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION RICK SCOTT ELIZABETH DUDEK GOVERNOR SECRETARY September 11, 2012 SPRINGWOOD CARE AND REHABILITATION CENTER 4602 NORTHGATE COURT SARASOTA, FL 34234 Dear Administrator: The attached license with Certificate #17737 is being issued for the operation of your facility. Please review it thoroughly to ensure that all information is correct and consistent with your records. If errors or omissions are noted, please make corrections on a copy and mail to: Agency for Health Care Administration Long Term Care Section, Mail Stop #33 2727 Mahan Drive, Building 3 Tallahassee, Florida 32308 Issued for a Status Change to Conditional Sincerely, Pp bbe O aco Agency for Health Care Administration Division of Health Quality Assurance Enclosure ce: Medicaid Contract Management Visit AHCA online at 2727 Mahan Drive, MS#33 ahca.myflorida.com Tallahassee, Florida 32308 Exhibit A Original Certificate of Conditional License 4602 Northgate Court, LLC d/b/a Springwood Care and Rehabilitation Center Certificate No. 17737 License No. SNF15130962 CLOC/TE/OT ‘-ALVG NOLLVaId Xd CLOC/0E/80 “HLVd AALLOSAda HONVHD SN.LV.LS Sddd Oct “IVLOL vETvE Td ‘VLOSVUVS Land ALVOHLYON 709P YALNYO NOLLVITTEVHAY GNV FAVOD GOOMONIadS :3UIMOTI[OJ oy} oyeIado 0} PEZHOYINE ST sosudo!] BY] SB puB ‘saynyels epLOLy ‘[] Weg ‘OOp JeideyD ur paezuoyjne ‘uoneNsTUTUpY sed Wop 10,4 Aouesy ‘epuopy Jo areig am Aq paidope suone[ngar pur sani oy) ym porto sey OTT ‘LUNOD ALVOHLYON 7209p Jeu} WEFUOD 0} St SY, TVNOILIGNOD HINOH ONISHON FONVANSSV ALITWNO HLTWIH AO NOISIAIC NOLLVULSININGYV FaVO HLTVAaH YOd AONADV BPLIOLy JO 93e)S STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No(s): 2012009469 13-1617 4602 NORTHGATE COURT, LLC d/b/a SPRINGWOOD CARE AND REHABILITATION CENTER, Respondent. SETTLEMENT AGREEMENT Petitioner, State of Florida, Agency for Health Care Administration (hereinafter the “A gency”), through its undersigned representatives, and Respondent, 4602 Northgate Court, LLC d/b/a Springwood Care and Rehabilitation Center (hereinafter “Respondent”), pursuant to Section 120.57(4), Florida Statutes, each individually, a “party,” collectively as “parties,” hereby enter into this Settlement Agreement (“Agreement”) and agree as follows: WHEREAS, Respondent is a Nursing Home licensed pursuant to Chapters 400, Part II, and 408, Part II, Florida Statutes, Section 20.42, Florida Statutes and Chapter 59A-4, Florida Administrative Code; and WHEREAS, the Agency has jurisdiction by virtue of being the regulatory and licensing authority over Respondent, pursuant to Chapter 400, Florida Statutes; and WHEREAS, the Agency served Respondent with an administrative complaint on or about September 17, 2012, notifying the Respondent of its intent to impose administrative fines EXHIBIT 2 in the amount of $10,000 and a survey fee of $6,000 and assign a conditional licensure status commencing August 30, 2012 and ending September 4, 2012; and WHEREAS, Respondent requested a formal administrative proceeding by filing a Petition for Formal Administrative Hearing; and WHEREAS, the parties have negotiated and agreed that the best interest of all the parties will be served by a settlement of this proceeding; and NOW THEREFORE, in consideration of the mutual promises and recitals herein, the parties intending to be legally bound, agree as follows: 1. All recitals herein are true and correct and are expressly incorporated herein. 2. Both parties agree that the “whereas” clauses incorporated herein are binding findings of the parties. 3. Upon full execution of this Agreement, Respondent agrees to waive any and all appeals and proceedings to which it may be entitled including, but not limited to, an informal proceeding under Subsection 120.57(2), Florida Statutes, a formal proceeding under Subsection 120.57(1), Florida Statutes, appeals under Section 120.68, Florida Statutes; and declaratory and all writs of relief in any court or quasi-court of competent jurisdiction; and agrees to waive compliance with the form of the Final Order (findings of fact and conclusions of law) to which it may be entitled, provided, however, that no agreement herein shall be deemed a waiver by either party of its right to judicial enforcement of this Agreement. 4. Upon full execution of this Agreement, Respondent agrees to pay $8,500 in administrative fines and a survey fee in the amount of $6,000 in accord with law. Respondent accepts the assignment of conditional licensure status commencing August 30, 2012 and ending September 4, 2012. In addition, the references in the Statement of Deficiencies relating to Resident #2 being on thickened liquids will be deleted. 5. Venue for any action brought to enforce the terms of this Agreement or the Final Order entered pursuant hereto shall lie in Circuit Court in Leon County, Florida. . 6. By executing this Agreement, Respondent neither admits nor denies, and the Agency asserts the validity of the allegations raised in the administrative complaint referenced herein. No agreement made herein shall preclude the Agency from imposing a penalty against Respondent for any deficiency/violation of statute or rule identified in a future survey of Respondent, which constitutes a “repeat” or “uncorrected” deficiency from surveys identified in the administrative complaint. The parties agree that in such a “repeat” or “uncorrected” case, the deficiencies from the surveys identified in the administrative complaint shall be deemed found without further proof. 7. No agreement made herein shall preclude the Agency from using the deficiencies from the surveys identified in the administrative complaint in any decision regarding licensure of Respondent, including, but not limited to, licensure for limited mental health, limited nursing services, extended congregate care, or a demonstrated pattern of deficient performance. The Agency is not precluded from using the subject events for any purpose within the jurisdiction of the Agency. Further, Respondent acknowledges and agrees that this Agreement shall not preclude or estop any other federal, state, or local agency or office from pursuing any cause of action or taking any action, even if based on or arising from, in whole or in part, the facts raised in the administrative complaint. This agreement does not prohibit the Agency from taking action regarding Respondent’s Medicaid provider status, conditions, requirements or contract. 8. Upon full execution of this Agreement, the Agency shall enter a Final Order adopting and incorporating the terms of this Agreement and closing the above-styled case. 9. Each party shall bear its own costs and attorney’s fees. 10. | This Agreement shall become effective on the date upon which it is fully executed by all the parties. 11. Respondent for itself and for its related or resulting organizations, its successors or transferees, attorneys, heirs, and executors or administrators, does hereby discharge the State of Florida, Agency for Health Care Administration, and its agents, representatives, and attorneys of and from all claims, demands, actions, causes of action, suits, damages, losses, and expenses, of any and every nature whatsoever, arising out of or in any way related to this matter and the Agency’s actions, including, but not limited to, any claims that were or may be asserted in any federal or state court or administrative forum, including any claims arising out of this agreement, by or on behalf of Respondent or related facilities. 12. This Agreement is binding upon all parties herein and those identified in paragraph eleven (11) of this Agreement. 13. ‘In the event that Respondent was a Medicaid provider at the subject time of the occurrences alleged in the complaint herein, this settlement does not prevent the Agency from seeking Medicaid overpayments related to the subject issues or from imposing any sanctions pursuant to Rule 59G-9.070, Florida Administrative Code. 14. Respondent agrees that if any funds to be paid under this agreement to the Agency are not paid within thirty-one (31) days of entry of the Final Order in this matter, the Agency may deduct the amounts assessed against Respondent in the Final Order, or any portion thereof, owed by Respondent to the Agency from any present or future funds owed to Respondent by the Agency, and that the Agency shall hold a lien against present and future funds owed to Respondent by the Agency for said amounts until paid. 15. The undersigned have read and understand this Agreement and have the authority to bind their respective principals to it. 16. This Agreement contains and incorporates the entire understandings and agreements of the parties. 17. This Agreement supersedes any prior oral or written agreements between the parties. 18. This Agreement may not be amended except in writing. Any attempted assignment of this Agreement shall be void. 19. All parties agree that a facsimile signature suffices for an original signature. The following representatives hereby acknowledge that they are duly authorized to enter into this Agreement. / | ia Susan Ritchie, Administrator 4602 Northgate Court, LLC Agency for Health Care Administration d/b/a Springwood Care and 2727 Mahan Drive, Bldg #1 Rehabilitation Center Tallahassee, Florida 32308 4602 Northgate Court Sarasota, Florida 34234 DATED: { | DANY DATED: _/2-6-73 Stuért F.“Williafns, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 DATED: /; al/ [7 Andrea M. Lang, Senior Attorney Agency for Health Care Administration 2295 Victoria Avenue Fort Myers, Florida 33901 DATED: 1 [4/1 Loh: Thomas W. Caufinar, Esq. Quitairos, Prieto, Wood & Boyer, P.A. 4905 West Laurel Street, 2™ floor Tampa, Florida 33607 Attorney for Respondent patep:_/2 - #-/3
