The Issue The issue to be presented is whether Respondent violated section 458.331(1)(t), Florida Statutes (2005), and if so, what penalty should be imposed?
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. Respondent, John Lee, M.D., is a licensed physician in the State of Florida, having been issued license number ME 50043. Dr. Lee specializes in obstetrics and gynecology, but is not board certified at this time. He has a solo practice. Dr. Lee has had one prior final order imposing discipline against him. On November 7, 1996, the Board of Medicine entered a Final Order approving an amended Consent Agreement entered between the Agency for Health Care Administration (the Department's predecessor with respect to regulation of health care professionals) and Dr. Lee. The Final Order imposed a letter of concern, a fine of $2,000, and 20 hours of continuing medical education. On or about November 2, 2005, patient R.R. first saw Respondent with a complaint of chronic pelvic pain and an inability to function. Based upon his examination of R.R., Respondent recommended that R.R. undergo a bilateral salpingo- oophorectomy (removal of both ovaries and fallopian tubes). R.R. decided to have the recommended surgery and on December 13, 2005, Respondent performed a bilateral salpingo- oophorectomy, as well as an appendectomy, lysis of adhesions and partial omentectomy. There are three layers to the bowel: the serosa is the thin outer protective layer; under the serosa is the muscularis; a third layer below the muscularis called the mucosa. Dr. Lee's surgical notes indicate that there was some serosal denuding of the sigmoid colon, but with no luminal extravasion (no leakage from the bowel). Dr. Lee described the serosal denuding as an irritation of the serosa from removal of adhesions, and not a complication of the surgery. In any event, there are no allegations in the Administrative Complaint claiming that either Dr. Lee's decision to perform the surgery or the performance of the surgery itself deviated from the appropriate standard-of- care, and no findings to that effect are found. R.R. was discharged from the hospital on December 15, 2005. At that time, she was ambulatory, tolerating liquids, had passed flatus and had a small bowel movement. At that time she had no documented fever and a normal white count. The next day, Friday, December 16, 2005, R.R.'s husband called Dr. Lee's office at approximately 3:00 p.m. According to R.R., she spoke to Brandi Melvin, now known as Brandi Harper (Ms. Harper), the medical assistant for Dr. Lee, and told her that she was running a fever of 101.8 degrees, did not feel well and wanted Dr. Lee to call her. She testified that at that time, she did not feel well, was achy all over, had pain in her abdomen and had chills. R.R. testified that Ms. Harper told her to increase her Dilaudid in accordance with her prescription and to continue rotating Tylenol and Motrin. She denies being told to go to the emergency room if her fever did not go down, and denies being instructed to pick up a prescription for an antibiotic. Brandi Harper is a medical assistant in Dr. Lee's office, and has been since 2004. She is a certified nurse's assistant and has completed a year and a half toward her registered nursing degree. Part of Ms. Harper's duties include screening calls that come in from patients post-surgery. In doing so, she follows a set protocol that has been established in that office. In accordance with Dr. Lee's preferences, she inquires not only about the symptoms the patients report having, but also about symptoms they may not be having. Consistent with that protocol, she testified that, with respect to the call from R.R. and her husband, she asked whether R.R. was having any drainage from the incision; any abdominal pain; or was experiencing any other symptoms. Ms. Harper testified that R.R. did not report having any abdominal pain above expected soreness, and did not report difficulty breathing or shortness of breath; drainage from the incision; vomiting; bloating or distension of the abdomen. Ms. Harper's testimony is credited. After receiving the telephone call from R.R., Ms. Harper wrote a note to Dr. Lee which referenced R.R. and stated, "[t]aking the cephalexin you gave her on discharge. Is running 102 temp, just sore. She has been rotating Tylenol and nothing has brought it down. Informed her to drink plenty of fluids. Do you want to add anything?" Neither Ms. Harper's notes nor her testimony reflect that she told the patient to increase pain medication. Nor does the note reflect that R.R. wanted to speak with Dr. Lee. Because Dr. Lee was seeing patients, Ms. Harper placed the note on his desk for his review. After reviewing the note, Dr. Lee wrote "Levaquin 500mg, #10, 1 a day." Ms. Harper then called the patient to tell her that a prescription was being called in for her and confirmed the pharmacy the patient used. At that time, consistent with the protocol established by Dr. Lee, she told R.R. or her husband that if the fever did not go down after two hours, to go to the emergency room at West Florida Hospital. She did not tell her to call the office back because, at the time of the return phone call, it was approximately 3:30 p.m. on a Friday afternoon, and in two hours the office would be closed. Ms. Harper then called the prescription in to Burklow's Pharmacy, as identified by the patient, and noted the prescription in patient's medication log. She noted the time of the call and the name of the pharmacist with whom she spoke. Ms. Harper did not note in the medical record that she advised the patient to go to the emergency room if her fever did not go down, and did not specifically note the return call to the patient. However, she plausibly explained that she could not call in the prescription to Burklow's without speaking to the patient, because there were two different pharmacies noted in her file previously. She also credibly testified that she always calls the patient back in conjunction with the call to the pharmacy, and gives standard instructions to post-operative patients regarding further action (in this case, going to the West Florida Hospital emergency room) should their condition not change. She does not necessarily document the return call because she does it so many times daily. Dr. Lee also testified that instructions to call back if the office is open or go to the emergency room if symptoms do not improve in a few hours is part of the standard protocol. Ms. Harper's and Dr. Lee's testimony is credited. R.R. did not go to the emergency room over the weekend and there was no evidence that she ever called Dr. Lee's office back after the 3:00 Friday afternoon call. She continued to not feel well, however, and on Monday morning, December 19, 2005, at approximately 5:00 a.m., she woke up in intense pain between her shoulder blades. She went by ambulance to Santa Rosa Medical Center (SRMC). R.R. went to SRMC as opposed to West Florida Hospital because it was much closer to her home. Dr. Lee does not have privileges at SRMC. Although R.R. went to the emergency room early December 19, 2005, there was no determination that first day that she had a bowel perforation, and she was not admitted to the hospital until approximately 8:30 that evening. At the time of admission, she had a white blood count of 3.3, with a differential count of 12 neutrophil bands. The history and physical taken at the hospital and signed by Dr. Michael Barber, M.D., states in part: HISTORY OF PRESENT ILLNESS: [R.R.] is a 33- year-old, . . . who underwent abdominal surgery six days ago by Dr. John Lee at West Florida Hospital. She had bilateral salpingo-oophorectomy, partial omentectomy, appendectomy, and extensive adhesiolysis. . . . She states that although this surgery was prolonged and reportedly difficulty (sic), she tolerated the surgery well and by the second postoperative day was ambulating and voiding freely, tolerating a regular diet with a bowel movement and positive flatus. She stated her pain was well managed with 4 mg of Dilaudid q4h as needed. She was sent home on Cephalexin 500 mg q6h, Phenergan 25 mg q6h and Dilaudid 4 mg q6h. She was also on Hydrochlorothiazide for chronic hypertension, Klonopin and Effexor for anxiety and depression. She states that after going home she had some anorexia that was doing well until the morning of admission. She was awakened from her sleep at approximately 6 a.m. with remarkable abdominal distention and severe diffuse abdominal pain. She developed nausea as the pain progressed but has had no vomiting. She states that other than the bowel movement immediately post surgery, she had not had any bowel activity since discharge in six days. After several hours and worsening of pain, she presented to the emergency room at Santa Rosa Medical Center. On admission, a CT scan of the abdomen was accomplished and revealed a moderate volume loss infiltrate in the left lung base, apparent present to a lesser extent on the right. There was free air noted within the abdomen and also noted to be some free fluid. This was felt to be due to the patient's prior surgery, however, a more acute process could not be ruled out. There were also some distended loops of small bowel with apparent decompression of the distal small bowel which suggested at least a partial small bowel obstruction, although again, the diagnosis included ileus. A CT of the pelvis was unremarkable except as noted on the CT scan. There was some free fluid and free air within the pelvis. Since transfer to West Florida Hospital and the patient's attending physician could not be arranged, decision was made to admit to Dr. Barber on GYN service. * * * IMPRESSION: Severe abdominal pain 6 days post exploratory surgery with bilateral salpingo-oophorectomy, partial omentectomy, appendectomy and adhesiolysis. No signs at this time of active infection or perforation. The most likely diagnosis is a severe postoperative ileus, however, the patient warrants close observation. An ileus occurs when the bowel is "asleep" and not moving. Dr. Barber transferred R.R. to the Intensive Care Unit overnight for close observation. R.R.'s temperature at the time of admission was 96.8. The History of Present Illness taken from R.R. does not mention the rise in temperature following discharge from West Florida Hospital, or the phone call to Dr. Lee's office. On December 20, 2005, Dr. Althar saw R.R. in consultation. At that time, her white count was 8.4 with 48 bands, indicating overwhelming sepsis. Dr. Althar took her immediately to surgery. Surgery revealed a bowel perforation of the sigmoid colon, and Dr. Althar performed a sigmoid colectomy, end colostomy, and Hartmann procedure. R.R. suffered some complications after surgery, which were not unexpected, and remained in the hospital until her discharge January 16, 2006. The Department presented the expert testimony of Robert W. Holloway, M.D. Dr. Holloway graduated from Vanderbilt University Medical School; completed his residency in Obstetrics and Gynecology at the University of Alabama at Birmingham; and completed a fellowship in gynecology oncology at Georgetown University Hospital. Dr. Holloway has been licensed as a medical doctor in Florida since 1990, and is board certified in obstetrics and gynecology, and gynecologic oncology. He is currently the co-Medical Director of the Gynecologic Oncology program at the Florida Hospital Cancer Institute in Orlando, Florida, and a clinical instructor for the Obstetrics and Gynecology Residency Program at Orlando Regional Medical Center. Dr. Holloway is in an office on the Florida Hospital campus, where there are four attending physicians and three follows in training. Fifty to 60 percent of his patients are oncology patients, with the remainder having benign issues. Dr. Holloway opined that in this case, the bowel perforated most likely late Sunday evening or early Monday morning, probably 6-12 hours before R.R. woke up in extreme pain. He found no violation of the standard-of-care regarding the denuding of the serosa in the original surgery, viewing it as an anticipated outcome with a difficult case of endometriosis. However, he opined that Dr. Lee fell below the appropriate standard-of-care when he failed to evaluate the patient on Friday afternoon when she had a temperature of 102 degrees. Dr. Holloway indicated that the most common indications of bowel perforation in post-operative patients are abdominal pain and fever. He knew of no cases where a perforation occurred with the patient presenting with fever alone. He also agreed that it is common for physicians to rely on their staff to triage patients, and to relay information back to patients. It is common, according to Dr. Holloway, for doctors to train staff to tell the patient to call back or go to the emergency room if a problem does not resolve itself, and staff normally does the majority of charting. With respect to the directions to the patient to call back or go to the emergency room, Dr. Holloway could not say that those directions are always noted in the chart for patients in his office, although they frequently are. Most importantly, Dr. Holloway could not conclude that Ms. Harper did not give the instructions to R.R. because it was not specifically noted in the chart, and he would be apt to give the staff the benefit of the doubt. He could not conclude from the absence of the note that proper instructions were not given. Dr. Holloway also indicated that he did not believe the bowel had perforated as of Friday afternoon when the call was made to Dr. Lee's office. Respondent presented the testimony of John Douglas Davis, M.D., who serves as the Director of Gynecology and Associate Residency Director of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine. Dr. Davis graduated from medical school at Wake Forest University and received his post-doctoral training at the University of Florida. Dr. Davis is licensed as a medical doctor in the State of Florida, and has been board certified in obstetrics and gynecology since 1992. Ninety-five percent of his patients are gynecological patients. Dr. Davis did not believe that Respondent violated the appropriate standard-of-care in his treatment of R.R. He opined that it is reasonable to rely on staff to perform triage functions with respect to calls from patients, and would interpret the note from Ms. Harper as not being indicative of bowel perforation. He testified that it was more likely to assume that the fever was caused by a pulmonary source, and the prescription for Levaquin was consistent with that assumption. In addition, the CT scan upon admission to SRMC was consistent with findings of pneumonia, and in Dr. Davis' view, the eventual determination that the bowel perforated does not mean that pneumonia was not also present. Like Dr. Holloway, Dr. Davis testified that bowel perforation does not present without severe abdominal pain, which was not reported to Dr. Lee. Dr. Davis opined that R.R.'s fever of 102 degrees must be interpreted in light of the patient's situation at discharge from the hospital, which Dr. Lee already knew. Most importantly, Dr. Davis testified that not seeing R.R. on Friday afternoon did not have an impact on her subsequent clinical course. His testimony is credited. In summary, it is found that Ms. Harper did instruct the patient to go to the emergency room at West Florida Hospital should her symptoms not improve after a couple of hours with the new medication. Dr. Lee's reliance on her to give that instruction is within the standard-of-care for a reasonably prudent similar physician under similar conditions and circumstances.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED that the Florida Board of Medicine enter a Final Order dismissing the Administrative Complaint in its entirety. DONE AND ENTERED this 23rd day of September, 2011, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings This 23rd day of September, 2011. COPIES FURNISHED: Elana J. Jones, Esquire Ian Brown, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Brian A. Newman, Esquire Pennington, Moore, Wilkinson, Bell and Dunbar, P.A. 215 South Monroe Street, Second Floor Post Office Box 10095 Tallahassee, Florida 32302 Nicholas W. Romanello, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32299-170 Joy A. Tootle, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399
Findings Of Fact On July 30, 1981, Petitioner filed an application with the Health Systems Agency of Northeast Florida, Area III, Inc. for a Certificate of Need to construct an enclosure on the fifth floor of the south wing of Petitioner's hospital. The purpose of that enclosure was in contemplation of future available bed space at a time when need for those beds had been documented and approved by the local health system's agency. (Petitioner's Composite Exhibit No. 2) In response to a request for further information which was made by the Executive Director of the local health system's agency, Rudolph Nudo, Director of Engineering for the Petitioner, answered that inquiry in writing by correspondence dated September 24, 1981. (Petitioner's Exhibit No. 3) Through the course of that correspondence Nudo indicated that the temporary use of the fifth floor would be for storage, and the fifth floor would be used in a permanent way for storage and expansion of the hospital's wellness and physical fitness programs should a determination be made in the future that additional beds are not needed in the review area of the local HSA. On November 23, 1981 the local HSA wrote to advise Herbert E. Straughn, Medical Facilities Consultant, Community Medical Facilities for Respondent, that the Northeast Florida Area III Health Systems Agency was recommending the denial of the proposed Certificate of Need. That correspondence had as an attachment the legal notices publicizing the public hearing related to the project, staff briefing memoranda and papers involved in the review process. (Respondent's Exhibits 4 through 4d) On January 27, 1982, Thomas J. Conrad, Administrator, Community Medical Facilities of the Office of Health Planning and Development, Department of Health and Rehabilitative Services, wrote to Charles Vadakin, President-General Manager of Petitioner, to advise Petitioner that the request for a Certificate of Need was being denied. (Petitioner's Exhibit 4) This indication of denial had as an attachment the State agency action report. (Petitioner's Exhibit No. 5) On February 5, 1982, in keeping with Subsection 120.57(1), Florida Statutes, Petitioner requested a formal hearing to consider its entitlement to be granted a Certificate of Need to "shell-in" the fifth floor at its facility. On February 17, 1982, the Division of Administrative Hearings received Respondent's request that the Division conduct the formal hearing. That hearing de novo was held on April 8 and 9, 1982. The evidence presented in the course of the hearing addressed the question of whether the proposal for construction by the applicant meets the criteria established in Section 381.494(6)(c), Florida Statutes and Rule 10- 5.11, Florida Administrative Code, in particular Rule 10-5.11(1),(3),(4),(6) and (12), Florida Administrative Code. (Those other criteria set forth in Rule 10- 5.11, Florida Administrative Code, have satisfactorily been addressed by the application process or are inapplicable in terms of the subject matter of the given criteria.) Evidence presented also dealt with the subject of whether this Certificate of Need could be granted due to extenuating and mitigating circumstances which exist, notwithstanding the applicant's failure to successfully meet the criteria discussed above. Memorial Hospital of Jacksonville is an acute general care hospital with a 309 bed capacity. The hospital is located in Jacksonville, Duval County, Florida. Petitioner has been granted Certificates of Need allowing the construction of an educational floor, perinatal center on a second floor and the third and fourth floors above those. The third and fourth floors would house an additional thirty-four beds, bringing the total bed count in the hospital to 343 beds. The construction is referred to as the south wing and is depicted at a certain point in the construction through Petitioner's Exhibit 1, a photograph of the area of construction. Memorial's present request for a Certificate of Need would allow the construction of an additional floor, or fifth floor, above the, four floors that have been granted. Memorial Hospital provides critical care, to include trauma cases treated in its emergency room and open heart surgery. In addition, there is a cardiac catheterization laboratory and other general cardiac care, an intensive care unit, a perinatal (birthing) center and other hospital services. The fifth floor, if constructed, would not immediately contain additional beds and would be left with interior partition walls and would be used for storage space in the interim period prior to the grant of any further beds to the Petitioner. The construction on the south wing which had been approved has its origins in Certificates of Need which were the topic of separate applications filed in 1979 and 1980. Specifically, in November, 1979, Memorial filed separate applications for its educational floor, first floor, in the amount of $2,991,000.00 and at the same time, an application for a perinatal unit, second floor, in the amount of $4,352,000.00. The applications were granted in 1980 in the amounts requested. At a later date in 1980, Petitioner filed a separate application for three additional stories; floors three, four and five, and for 106 additional beds, all in the cost amount of $10,656,000.00. This request came about at approximately the same time as a request by St. Luke's Hospital in Jacksonville, Florida, to move its hospital operations to an area in the vicinity of Memorial Hospital. Memorial and St. Luke's, together with the local HSA, resolved the problem of the competing certificate requests by entering into a stipulation and agreement in 1981. By the terms of that agreement, Memorial limited its expansion to two floors instead of three, leaving floors three and four intact. It reduced its bed request from 106 to 34 additional new beds to be installed on one of the two additional floors, with the second additional floor receiving 34 beds from another part of the hospital which was not subject to the Certificate of Need. The second set of beds would be gained by the process of converting existing semi-private rooms to private rooms. Petitioner also agreed not to apply for additional beds until at least six months after the perinatal unit and 34 new medical/surgical beds had been opened. St. Luke's reduced its number of obstetric beds by 20 and it agreed that it would not "shell-in" space for additional beds in its proposed facility. The results of the agreement caused the abandonment by Memorial of its fifth floor request and the reduction of bed requests by 72 beds. The new terms are set out in Certificate of Need No. 1488 pertaining to floors three and four. The project costs were left as originally requested, and that monetary amount was granted. The agreement reached between the local HSA, Petitioner and St. Luke's was premised upon extenuating and mitigating circumstances, especially the possibility of the cost of protracted litigation had the parties not come to an agreement. Following the stipulation and agreement with the local HSA and St. Luke's Hospital, the Petitioner filed the present request for Certificate. The general purpose of that project has been discussed before. The rationalization on the subject of consistency of the project with the local Health Systems' plan and the local annual implementation plan was as follows: The proposed enclosure project is consistent with Health Systems' plan and annual implementation plan for 1980, in that it provides a mechanism for assuring available health care resources at the lowest possible cost consistent with quality service delivery. The proposal guarantees no additional beds will be added until approved by the Health Systems Agency and yet safeguards the most effective option of maximizing current capital investment dollars. This project will allow Memorial Hospital to continue to meet the area's acute health care needs for the next ten years. The project contemplates the expenditure of $1,200,000.00 for cost of construction of "shell-in" space. Need for the subject project was discussed in terms of a reference to "Certificate of Need #1488" which is that Certificate relating to floors three and four of the south wing. The Certificate of Need No. 1488 was based upon an application which included a study concluded in August, 1980, which set forth primary and secondary service areas, census tracts and preliminary 1980 Federal census figures for Duval County gathered by the "Research Department, Florida Publishing Company" and a document to the effect that Memorial had a firm market position, and that health care consumerism was emerging and that there was a strong consumer loyalty-to Memorial. The present application was reviewed by the local Health Agency and the Health Needs and Priorities Committee voted to recommend denial of the proposed project; its Executive Committee also recommended denial of the project. During this review cycle, concerns were expressed about the application in view of the 1981 agreement with St. Luke's and the local HSA in which Memorial agreed not to apply for additional beds for at least six months after the 34 beds which had been approved were in operation. While the present application does not violate the terms of that agreement, it does allow for a large portion of the capital expenditure, i.e., that part devoted to the construction of the "shell-in" of the floor to be achieved and thereby allows for a portion of the capital expenditure related to future beds to be approved. With St. Luke's relocation to south Jacksonville, some time in late 1984 or early 1985, and with the addition of Memorial's construction program that has been approved, 323 beds will be added to the south side area of Duval County in the next few years. In the local HSA staff's opinion, which opinion is accurate, from a community planning basis, there will not be a demonstrated community need for additional beds in the south side any sooner than 1985 and it is more likely that there would be no further bed need before 1990. The local HSA is also concerned that the project would set a precedent for future "shell-in" applications. This concern is borne out by interviews conducted through staff members of that HSA which revealed that seven hospital administrators planned major construction projects in the HSA area, and six administrators indicated that they would ask for "shell-in" space if they thought it would be approved. In specific terms, the local HSA recommended disapproval of the project and did so by written findings alluded to before. In summary, those findings indicated: The Health System's Plan did not address expansion projects which do not directly result in an increase in licensed beds or service but the primary purpose of the fifth floor would be for bed spaces. The Health System's Plan called for a regional rate of 4.3 beds per 1,000 population. Excluding Nemour's Children and St. Johns River Hospital, there were approximately 4.1 beds on the south side and beaches area of Jacksonville. When St. Luke's Hospital (289 beds) relocates to the south side and Memorial opens its 34 new beds, the rate will be approximately 5.2 beds per 1,000 population in 1985. In 1990 the estimated rate would be 5.0 beds per 1,000 population. It was HSA's staff's opinion that there will not be a need on a community planning basis to approve more beds for the south side until the 1990s. The local HSA also indicated that Memorial could be more effective in its specialization. Its recommendation in that regard was that after the current construction of four stories had been completed, Memorial could still have the capability to add additional licensed beds within its presently approved structures, even though it would mean reducing the ratio of private beds to semi-private beds. Specifically, it was recommended by the HSA that: Petitioner reconvert the 34 rooms previously used for semi-private back to semi-private --34 beds Modify the 34 private rooms on the third floor of the new building to semi-private, and --34 beds Modify the 34 private rooms on the fourth floor of the new building to semi-private. --34 beds TOTAL 102 beds These observations and findings are correct, except as they relate to modification of rooms on the third and fourth floors of the new construction. The above-stated suggestion by the local HSA related to the modification to semi-private rooms on the third and fourth floors of the south wing would not comport with the design specifications of those beds as now contemplated by Memorial, in that the private rooms contemplated on those floors did not provide sufficient space to be modified into semi-private rooms. Analysis by HRS adopted and confirmed the majority of the analysis by the local Health Planning Agency. HRS also pointed out in its analysis, and the HRS analysis is accurate, that in view of the fact of excess bed capacity in the planning area through 1985, the adding of potential beds would give Petitioner an undue advantage over facilities should the fifth floor be constructed as "shell-in" space. Furthermore, according to Respondent, construction economies to be realized by Memorial Hospital can only be recognized as legitimate, if there is a community need for the project. Based upon the analysis conducted by Respondent, the project from a community-wide standpoint, under the terms of Section 381.493, Florida Statutes, there is an excess of 238 hospital beds in Duval County through 1985, and possibly into early 1990. Respondent having in mind the bed need situation, concluded that the proposed project was not consistent with bed need standards at the time of review or in the planning future and that the community need to add "shell-in" bed space did not exist absent a recognized bed need, which would not occur before 1985. All of these comments by HRS are correct accounts. It was also concluded by Respondent that there were alternatives for converting private bedrooms to semi-private rooms, increasing capacity without major construction. This is a true understanding of the circumstances except as it relates to the third and fourth floors in the new construction. Based upon the overall analysis, the project application was denied. The conditions at Memorial Hospital are such that it would benefit from an expansion to add a fifth floor at the south wing. Those benefits pertain to the availability of storage and administrative space. The occupancy rate for patients in the hospital during the last year have averaged approximately 90 percent (Petitioner's Exhibit 16), causing both emergency and planned health care services to be delayed due to overcrowding. Federal, State and HSA guidelines call for 80 percent occupancy of nonfederal, short-term care beds, such as provided by Petitioner. There is a need for administrative office space. At the present time some administrative offices are placed in lobbies and hallways and the files for those offices are located in hallways. Intravenous solutions are stored in hallways at present. Testimony by the hospital engineer established a need of 15,000 square feet of space to accommodate storage problems more comfortably. The application seeks 17,500 square feet of space. The alternatives to the construction of the fifth floor related to future bed need and short and long-term storage space would be to forego the expansion, construct the project at a future date, or construct a new building. Construction at a later date could cost as much as an additional $7,000,000.00, constituted of approximately $813,000.00 in construction cost and $6,000,000.00 in loss of gross revenue. These costs are related to completion of the "shell-in" structure after the initial four floors had been completed and assumes loss of revenue related to beds in the third and fourth floors of the hospital, which floors would have to be closed during the construction of the fifth floor at a subsequent time. Construction costs at the present, as set forth in Petitioner's Exhibit No. 3, at the last sentence of the first page, is estimated to be $.31 per-patient day. There is precedent for granting the "shell-in" space as may be found in Petitioner's Exhibits Nos. 8, 9, and 10, related to projects in the Florida Gulf Health Systems Agency, Inc. area of responsibility. Respectively, those projects refer to Women's Hospital in Tampa, Florida; St. Joseph's Hospital in Tampa, Florida; and L. W. Blake Memorial Hospital in Bradenton, Florida. In the situation of Women's Hospital, Respondent allowed the construction by installation of necessary structural equipment and fixtures needed to establish 34 single occupancy rooms as double occupancy rooms as a hedge against construction costs for any additional beds approved at a future date. St. Joseph's Hospital was allowed to construct two floors in which 45 beds had been requested, but only 36 beds were granted per floor, leaving additional "shell-in" space which would accommodate nine additional beds per floor, for a total of 18 beds. In the situation at Blake Memorial Hospital in Bradenton, Florida, that hospital was allowed to "shell-in" a fifth floor on condition that the structural framework would be completed and that the floor would be left in an unfinished state, that is to say, that the improvements necessary for the utilization of that fifth floor for patient rooms were not allowed to be added. In each instance in which some form of "shell-in" space was granted, the HSA area was overbeded at the time of the grant of certificate. The project is not consistent with the local health systems plan, annual implementation plan, and Florida State Health Systems Plan. (Petitioner's Exhibits 11 through 14 respectively)
Findings Of Fact The Parties FRTC is a wholly-owned subsidiary of Charter Medical Corporation which proposes to construct and operate a 60 bed intensive residential treatment program (IRTP) in Bradenton, Florida, which is located in the Department's District VI. The Department is the state agency with the authority and responsibility to consider CON applications. Manatee Palms is an existing residential treatment center in Manatee County, Florida which opened in January, 1987 and is currently operating without a CON. It provides services similar or identical to those proposed by FRTC. Manatee Palms was developed by, and is a subsidiary of, Psychiatric Institutes of America. Its primary service area extends beyond District VI from Orlando to Naples. Manatee Palms is a sixty bed facility providing psychiatric, substance abuse and educational services for juveniles up to 18 years of age, and is licensed by the Department as a child caring facility, as a provider of services to the Department, and for subspecialties involving drug and alcohol programs. It is accredited by the Joint Commission on Accreditation of Hospitals as a residential treatment center. The average length of stay for patients is six months. Occupancy rates have been consistently above projections and have been as high as 97 percent in May, 1987. Manatee Memorial is a full-service acute care hospital and an existing provider of short-term psychiatric services in Bradenton, Florida, with 25 licensed short-term psychiatric beds, nine of which comprise a children's and adolescent unit. It is the Manatee County contract provider of in-patient psychiatric services to the medically indigent, and provides approximately 91 percent of the indigent care in Manatee County. Manatee Memorial does not have, and has never sought, a CON as an IRTP, but does have earlier-batched applications pending for additional short and long term psychiatric beds. Its average length of stay is 35-40 days, and its utilization rate is approaching 100 percent. Manatee Memorial provides services similar or identical to those proposed by FRTC, and its program also utilizes a "levels system" similar to that used by FRTC. The Application and Project On September 15, 1986 FRTC filed a Letter of Intent notifying the Department of its intent to file a CON application for an IRTP for children and adolescents in Bradenton, Florida. On October 14, 1986 FRTC filed CON application number 4825 to obtain specialty hospital licensure as an IRTP. This application was initially approved by the Department on March 10, 1987, after the filing of a completeness response on or about December 23, 1986 at the request of the Department. Manatee Palms and Manatee Memorial timely filed petitions for formal administrative hearings challenging the Department's intent to issue the CON. The project at issue in this case is a 60 bed IRTP situated on a 9.35 acre site. The proposed building will have total gross square footage of approximately 32,000 and has been adapted from a prototype short-term psychiatric hospital design which has been used in approximately 50 locations. The floor plan submitted by FRTC provides for 28 semi-private rooms, three of which are designed to accommodate the handicapped, and one 4- bed assessment unit. Additionally, reasonable and sufficient space is provided for five classrooms, occupational therapy, a gymnasium, three group rooms, three day rooms, a seclusion area, three consult rooms, laundry and storage rooms, a nurses' station, dining room, and an administrative wing. A parking area, multi-purpose court, pool, activities field and drainage retention area are also provided. The parties have stipulated that the building will be energy efficient. Total project cost is reasonably estimated at $4,303,020. As a result of design modifications, the square footage of the project has increased by approximately 1,000 gross square feet and project costs have increased by approximately $69,000 from FRTC's completed application. The Department's Deputy Assistant Secretary for Regulation and Health Facilities, John Griffin, testified that for a project of this size these changes are not considered to be "amendments" to the application. The changes in facility design identified at hearing represent refinements and permissible modifications, rather than application amendments. There is no architectural significance to the changes. Rather, they make the design more appropriate for an IRTP. Specifically, a multi-purpose area was converted to a half-court gymnasium, the occupational therapy and interior mechanical spaces were slightly increased for more storage area, a seclusion room was deleted, the nurses' station was reduced, a 4-bed assessment unit was added, and other minor changes were made. FRTC proposes to offer 24-hour psychiatric services to children and adolescents under the age of 18, who are severely emotionally disturbed, and who are admitted voluntarily, after screening, with a history of prior treatment. Its program elements will include occupational therapy, recreational therapy, group and individual therapy, nursing care, an educational component, psychological testing, counseling and family therapy. The FRTC program will be initiated as a locked intensive program whose goal is to return the patient to his family and to life in a natural setting. Patients who are severely retarded, autistic, or with an active diagnosis of substance abuse will not be admitted. The average length of stay for patients is reasonably projected to be one year, with a range of from 6 months to two years. There are no licensed intensive residential treatment programs (IRTP) for children and adolescents in Manatee County, Florida or in the Department's District VI, which includes Manatee County as well as Hardee, Highland, Hillsborough and Polk Counties. There are also no licensed IRTPs in adjoining Districts V and VIII. Stipulations The parties have stipulated that FRTC has the ability to recruit physicians for this project, and also has funds available for FRTC's capital and operating expenditures. In addition, the parties have stipulated that review criteria concerning the need for research and educational facilities, the extent to which the services will be accessible to schools for health professional, and the special needs and circumstances of health maintenance organizations are not applicable to this CON application. Non-Rule Policy For IRTP The Department currently has no rule governing the approval of IRTP applications for a CON. However, since February 1987 the Department has followed a non-rule policy which presumes there is a need for at least one licensed IRTP of reasonable size in each Departmental service district, and which does not consider the existence of unlicensed residential treatment beds in a district in determining if the presumed need has been met. No changes or revisions in this non-rule policy of the Department are under review. The Department applied this non-rule policy in initially approving the CON application. Based upon the testimony of John Griffin, the Department's Deputy Assistant Secretary who administers the CON program and is responsible for health planning, an IRTP applicant does not have to establish "need" in a particular service district where it wants to locate a facility because the non- rule policy presumes there is a need for one IRTP of reasonable size per district. The applicant must, however, establish that there is not presently a licensed IRTP in the district and that it proposed to establish an IRTP of reasonable size. Griffin was not able to explicate this non-rule policy based upon health planning concerns, considerations or factors. Sharon Gordon-Girvin, Administrator of the Department's Office of Community Medical Services and Facilities, was also unable to articulate or explicate a health planning basis for this policy. Rather, the only basis enunciated at hearing by the Department for this non-rule policy was its statutory interpretation of Sections 395.002(8) and 395.003(2)(f), Florida Statutes, as renumbered by Section 34, Chapter 87-92, Laws of Florida. Need And Consistency With State And Local Health Plans There are no licensed IRTPs in District VI. Manatee Palms is a residential treatment center for children and adolescents located in Manatee County, but it is not licensed by the Department as an IRTP. Relevant issues identified in the District VI Local Health Plan are stated as follows: As a general policy, the least restrictive, most cost effective setting and programs should be used. The State of Florida, as a major purchaser of mental health and substance abuse services, can continue to lead the way by encouraging the development of non-hospital alternatives and by purchasing services from them preferentially. Another important issue in psychiatric care is the trend toward hospitalization of children who have behavior and conduct disorders, and who should more appropriately be served through non-hospital alternatives. . . At the present time, the severe emotionally disturbed or emotionally handicapped (SED/EH) child or adolescent is served in a broad range of programs. There are crisis stabilization units (CSUs) for stabilizing the adult client in acute crisis. Currently CSU services for children and adolescents are not adequate throughout the District. Intensive residential, day/night program, group and foster homes are for the client requiring close supervision. Relevant policies set forth in the District Local Health Plan are as follows: The multi-modality approach as expressed in the community mental health (and substance abuse) system should be considered a model of programming, staffing, facility requirements, costs, etc., against which applications for inpatient services should be reviewed. Review of applications for inpatient psychiatric and substance abuse services should include comment from the Alcohol, Drug Abuse and Mental Health Program Offices of DHRS. No additional psychiatric and/or substance abuse beds should be granted approval unless the capacity of current hospital providers is being fully utilized (75 percent occupancy rate annual). Additional psychiatric and/or substance abuse beds should be through conversion of existing beds. The State Health Plan sets forth the following relevant policies and statements: The goal of (mental health) services is (to) . . . provide educational; mental health treatment; and when needed, residential services for severely emotionally disturbed students. It is the intent of the Legislature that the least restrictive means of intervention be employed based on the individual needs of each patient within the scope of available services . . . The program goals for each component of the network are . . . to provide programs and services as close as possible to the child's home in the least restrictive manner consistent with the child's needs. Sufficient funding for the development of residential treatment and community support services is necessary if the state is to fulfill its commitment to providing services for long term mentally ill persons. These services provide, in the long run, a more humane and cost effective means of meeting the mental health needs of Florida residents. Continued development of long and short term inpatient hospital programs for the treatment of adolescents and children is contrary to current treatment practices for these groups and is, therefore, inappropriate without local data to support the need for these services. Such development can contribute to inappropriate placement, unnecessary costs of treatment, and divert scarce resources away from alternative uses. In addition, the following relevant goals are contained in the State Health Plan: Promote the development of a continuum of high quality, cost effective private sector mental health and substance abuse treatment and preventive services. Bring about changes in third party reimbursement policy for psychiatric and substance abuse care which would promote the development of the most appropriate, cost-effective treatment settings . . . Develop a network of residential treatment settings for Florida's severely emotionally disturbed children by 1989 . . . Develop residential placements within Florida for all SED children currently receiving treatment in out of state facilities by 1990. The FRTC application is consistent with the above cited relevant portions of the state and local health plans. It is consistent with the State Health Plan which reflects and emphasizes the trend toward deinstitutionalization and the current emphasis on education, treatment and residential services for severely emotionally disturbed students rather than what has been the traditional approach to treatment in an institutional setting, a generally more costly approach from a capital cost and staffing perspective. The FRTC application promotes treatment within the State and will assist in reducing out of state placements. Through the report and testimony of Ronald T. Luke, Ph.D., J.D., and despite the testimony of Jay Cushman, both of whom were accepted as experts in health planning, FRTC established the need for, and reasonableness of, its 60 licensed IRTP beds in District VI, with 50 percent occupancy in the first year and 60 percent in the second year, using two bed need assessment methodologies. First, using the ratio of licensed IRTP beds in other service districts to population ages 0-17 years old, a range of .07 to 1.33 beds per 1,000 population is identified. Using 1991 population projections for District VI, the 60 bed FRTC facility would result in a bed to population ratio of .17 per 1,000 population aged 0-17 years. Since there are no licensed beds in the current inventory, no adjustment of this ratio must be made to account for existing beds. Thus, the FRTC application is within the range of ratios of currently licensed IRTPs in other districts, and is therefore reasonable. Second, a utilization methodology identifies an intensive residential treatment bed need of 90 in 1987 to 95 in 1991, with target occupancy rates of 90 percent. This methodology is based upon 1987 and 1991 population projections. Using a census rate per 100,000 population of 21.58 which is appropriately and reasonably derived from national data for residential treatment patients aged 0-17, an average daily census of 74 in 1987 and 78 in 1991 is derived. Thus, FRTC has established a need for its facility in District VI, given its projected occupancy levels, and given that there are no licensed beds currently in the District. It is important to recognize that the bed ratio analysis is based upon licensed intensive residential treatment beds in Florida, and is therefore clearly relevant and credible to the issues in this case. The utilization methodology supports and confirms the need found thorough the bed ratio analysis, although it is noted that this methodology, by using national data, is not based upon licensed beds in Florida, and would therefore not be sufficient, in itself, to establish need. It is, however, persuasive and credible in confirming the bed ratio analysis. Accessibility To All Residents FRTC projects only 1.5 percent indigent care and 8 percent bad debt. Its projection for private pay patients is 25 percent and for insurance covered care is 65.5 percent. This is a marginal and insignificant indigent load. There is no provision for services to state-funded patients. FRTC's projected utilization by class of pay is reasonable. The clear purpose of this application is to enable FRTC to become licensed as a hospital under Section 395.002, Florida Statutes, and thereby enable it to be called a "hospital". It was established through the testimony of Dwight Hood, who was accepted as an expert in health care finance and health care third party payments, that if a facility is licensed as a hospital it has a significant advantage for reimbursement from third parties who more readily reimburse for care in a licensed facility than in an unlicensed residential treatment center. Therefore, accessibility will be increased for those children and adolescents in need of this care whose families have insurance coverage, since it is more likely that payments under such third party coverage will be made at an IRTP licensed as a "hospital" than otherwise. Quality of Care The applicant has clearly demonstrated its ability to provide quality care to its patients, based upon the testimony of C. Hal Brunt, M.D., Robert Friedel, M.D. and G. L. Tischler, M.D., who were accepted as experts in psychiatry, and notwithstanding the testimony of Howard Goldman, M.D., and Glen Lewis, M.D., who were also accepted as experts in psychiatry. FRTC is a wholly owned subsidiary of Charter Medical Corporation which has experience in the operation and management of a residential treatment center, Charter Colonial Institute in Virginia, and also has extensive experience in providing quality health care at five hospitals in Florida, including Charter Hospital of Tampa Bay. The treatment program at FRTC will be adapted to local community needs. In providing quality care, FRTC will assign patients to the correct level of care within the facility by insuring that they are seen by a psychiatrist within 24 hours of admission, and by having each case reviewed by an independent utilization review committee, completing appropriate patient assessments and developing integrated treatment programs which are regularly updated, making appropriate treatment outcome assessments, and providing for continuity of care for patients leaving the IRTP through the development of a community-wide continuum of care. Charter has six out-patient counselling centers located within two hours of the FRTC proposed facility. It is both reasonable and appropriate to structure psychiatric treatment and care in a hospital setting within a "levels system" that rewards and reinforces desired behavior, and FRTC will utilize a "levels system" in its highly goal oriented patient treatment programs. Quality of care is not dependent upon a hospital's environment and physical facilities, according to Dr. Goldman. The floor plan proposed by FRTC is functional and is a proto- typical design used by Charter in approximately fifty locations, although not as an IRTP. The criticisms of the floor plan and facility design to which Maxine Wolfe, Ph.D., and Glen Lewis, M.D., testified do not establish that the applicant will be unable to provide quality care in this facility. While the Petitioners might design a facility differently, and specifically provide for a different orientation of the nurses' station relative to the patient wings, a different location for the dining room, more rooms where a patient can have privacy, and more opportunity for individualized treatment, these preferences do not establish that FRTC's floor plan and design will impair the quality of care rendered at this proposed facility. It is also noted that Dr. Wolfe testified critically about residential treatment in general, and expressed the opinion that residential treatment in a hospital is not beneficial and that children should never be treated in a large facility of any kind under any circumstance. Her testimony clearly establishes her bias and impairs her own credibility and the weight to be given to her testimony in this case. Availability and Adequacy of Alternatives Although there are no licensed IRTPs in District VI residential treatment and/or psychiatric services are currently available to children and adolescents through Manatee Memorial (9 beds), Manatee Palms (60 beds), Glenbeigh (14-16 beds), Sarasota Palms (60-70 beds), Sarasota Memorial Care Center (30 beds), Children's Home in Tampa (68 beds) and Northside Center in Tampa (12 beds). The average of length of stay at the significant majority of these facilities is up to 90 days, and they also attract patients from outside District VI. FRTC proposes to serve patients who require an average length of stay of a year. Some of these facilities serve patients with a dual diagnosis that includes substance abuse whereas FRTC will not. Therefore, these facilities do not offer adequate alternatives for the patients which FRTC is seeking to serve. Further, it was not established that outpatient or ambulatory services represent an adequate and appropriate alternative to an IRTP. Availability of Resources The total project cost of $4,303,020 will be funded through an equity contribution from Charter Medical Corporation and through a conventional loan. Assuming a 50 percent occupancy rate (30 beds) in its first year of operation, the proposed facility will have a staff of 43 positions, 27 of which will represent personnel who will be direct nursing or staff support for the patients, including social workers, psychologists, staff registered nurses, mental health workers, patient care coordinator, nursing supervisors, occupational and recreational therapists and special education teachers. A part-time medical director will also be available. This results in a ratio of 1.4 positions per patient. In comparison, Manatee Palms has a 1.8 staffing ratio based on a census of 55 patients. FRTC has proposed a reasonable and adequate staffing pattern and ratio to treat 30 patients. FRTC will recruit personnel through direct advertising, community contacts, posted notices, job fairs, and school visits. It will compete with unlicensed residential treatment centers, as well as short and long term psychiatric hospitals, in attracting staff for its facility. Although only six mental health workers are identified in FRTC's list of manpower requirements, and it would be beneficial to the level of treatment and care to increase this number, nevertheless, the staffing patterns proposed by FRTC will allow it to render quality care to patients at its facility, based upon 50 percent occupancy in its first year of operation. Staff salaries proposed by FRTC are reasonable and realistic, although its proposed salaries for nurses and mental health workers are higher than that available at Manatee Memorial. Existing facilities may have to increase their salaries to the levels proposed by FRTC to continue to retain and attract qualified staff, particularly nurses and mental health workers. Recruitment difficulties have been experienced in the District VI area for nurses, social workers, mental health workers and occupational therapists. However, it appears that FRTC will be able to attract qualified applicants for all positions due to the level of salaries offered and quality of care provided. Financial Feasibility Net revenues from the first year of operation are projected to be $100,000, which represents 2.3 percent of the capital expenditure as a return on investment. In the second year of operation, net revenues are projected to be $302,000, a 7 percent return on investment. Both years show a fair return on investment, and the pro forma establishes the financial feasibility of this project. In preparing the pro forma for this project, William S. Love, who was accepted as an expert in health care finance, used the reasonable assumption of 50 percent occupancy in the first year of operation and 60 percent in the second year. Despite the testimony of Jay Cushman, who was accepted as an expert health planner, it was not established that FRTC's location will preclude these occupancy rates. Love also assumed patient revenues of $300 per day and an average length of stay of one year. Utilization by class of payor was estimated to be 65 1/2 percent insurance, 25 percent private pay, 8 percent bad debt and 1 1/2 percent indigent care. It was assumed there would be no Medicare or Medicaid. Assumptions regarding patient revenues and utilization by class of payor are reasonable based on the testimony of Love, Luke and Dwight Hood, as well as a survey of insurance benefits available through employers, and despite the testimony of Christopher Knepper, who was accepted as an expert in health care finance. Knepper's testimony is applicable to unlicensed residential treatment centers rather than an IRTP. Therefore, his criticism of the pro forma as underestimating bad debt and overestimating the private pay portion is not persuasive since it disregards the fact that a licensed IRTP, due to its status as a specialty hospital, will have an increased ability to attract patients with insurance and with an ability to pay deductibles and other unreimbursed costs for care. It was established that a residential treatment center licensed as a specialty hospital has a significant advantage in terms of an improved payor mix over unlicensed facilities because of its recognized status with insurance companies. In addition, Knepper's testimony at hearing concerning the financial feasibility of this project conflicted with estimates made during discovery, and his explanation of such discrepancy was not credible. This conflict in Knepper's position at hearing and during discovery reduces the weight to be given to his testimony. FRTC assumed it would not be subject to the indigent care tax, but even if it were subject to the tax this would only add $29,000 in expenses, and therefore not affect the financial feasibility of the project. A management fee will be charged by Charter Medical Corporation, although this is not separately shown on the pro forma. It is the position of FRTC that this fee is associated with home office costs which will exist without regard to this facility. However, this fee, as well as additional construction costs of approximately $70,000, will not affect the financial feasibility of this project since salary costs associated with administration, as well as data processing costs have been separately shown and included on the pro forma as expenses, even though they are sometimes included in a management fee. FRTC's estimate of gross patient revenue of $300 per day for the first year of operation is substantially higher than other facilities offering like services. Net revenues per day during the first year of operation are estimated to be $265.30. Total direct expenses are estimated to be $198.70 for the first year, with total expenses per patient day estimated at $250.50 in the first year. A 7 percent inflation factor was used for the second year of operation, and this is a reasonable inflation factor. Impact On Costs and Competition As previously noted, salary estimates for nurses and mental health workers for this project are above those provided at Manatee Memorial, and therefore could reasonably be expected to increase salaries in these categories for some facilities in the area. The all inclusive charge of $300 per day proposed by FRTC is greater than Manatee Palm's average gross charge of between $270 - $280 per day. It is likely that paying patients, including patients with insurance coverage, who would otherwise be treated at Petitioners' facilities, will be treated at FRTC if this application is approved. However, the extent of such a loss in paying patients due to FRTC is unclear since Manatee Palms is recently receiving greater acceptance by insurers for reimbursement purposes, and Manatee Memorial's estimates of patient losses were based upon impact from both Manatee Palms and FRTC. Reasonableness of Costs The equipment cost estimate of $360,015 is reasonable. This finding is based on the testimony of Susan Hickman, who was accepted as an expert in health care facility equipment. The equipment and beds are appropriate for an IRTP of this size. The total cost of $707,897 for telephones, signage, graphics, interior design and equipment is also reasonable. The construction cost estimate of $2,010,823 is reasonable. This finding is based on the testimony of Patrick A. Regan, who was accepted as an expert in health care facility construction budgeting. Due to the conservative nature of the cost figures, a 2 1/2 percent contingency is adequate, rather than the normal 5-6 percent contingency. The contingency could be used for unbudgeted items such as stucco siding and hard ceilings. FRTC owns the facility site, which was purchased for $664,000.
Recommendation Based upon the foregoing, it is recommended that the Department enter a Final Order approving FRTC's application for CON 4825. DONE AND ENTERED this 22nd day of December, 1987 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of December, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NOS. 87-2036, 87-2049 Rulings on the Joint Proposed Findings of Fact filed by FRTC and the Department: 1 Adopted in Findings of Fact 1, 27. 2-4 Adopted in Finding of Fact 6. 5 Rejected as irrelevant and unnecessary. 6-9 Adopted in Findings of Fact 8, 29, but otherwise rejected as cumulative and unnecessary. 10-11 Adopted in Finding of Fact 8. Adopted in Finding of Fact 47. Adopted in Findings of Fact 8, 47. Adopted in Finding of Fact 8. 15-16 Adopted in Finding of Fact 46, Adopted in Finding of Fact 27. Adopted in Finding of Fact 28, but otherwise rejected as irrelevant and unnecessary. Adopted in Findings of Fact 9, 10 but otherwise rejected as unnecessary. Rejected as irrelevant and unnecessary. 21-22 Adopted in Finding of Fact 9. Adopted in Finding of Fact 28, but otherwise rejected as unnecessary. Rejected as unnecessary. Adopted in Findings of Fact 9, 10, 27. Adopted in Finding of Fact 9. 27-30 Adopted in part in Findings of Fact 27, 28, but otherwise rejected as unnecessary. 31 Adopted in Finding of Fact 9. 32-34 Adopted in Findings of Fact 27, 28, but otherwise rejected as unnecessary. Adopted in Finding of Fact 12. Rejected as unnecessary. Adopted in part in Finding of Fact 33, but otherwise rejected as unnecessary. Adopted in Findings of Fact 33, 35. Adopted in Finding of Fact 34. Adopted in Finding of Fact 37. Adopted in Finding of Fact 12. Rejected as unnecessary. Adopted in part in Finding of Fact 39, but otherwise rejected as unnecessary. Adopted in Finding of Fact 40. Adopted in Finding of Fact 42. Adopted in Finding of Fact 39. Adopted in Finding of Fact 40. Adopted in Finding of Fact 38. Adopted in Finding of Fact 39. 50-57 Adopted in Findings of Fact 26, 39, but otherwise rejected as cumulative and unnecessary. 58 Rejected as unnecessary. 59-61 Adopted in Finding of Fact 15, but otherwise rejected as irrelevant, unnecessary or as a conclusion of law. 62 Adopted in Finding of Fact 16. 61 Adopted in Findings of Fact 6, 15, 16. Rejected as unnecessary and irrelevant. Rejected in Finding of Fact 17. Rejected in Finding of Fact 17, but adopted in part in Finding of Fact 26. Rejected as irrelevant and unnecessary. Rejected as unnecessary. 69-72 Adopted in part in Finding of Fact 24, but otherwise rejected as irrelevant since the Department's non-rule policy was not explicated and therefore cannot be relied upon. Rejected as unnecessary and irrelevant since the "reasonableness" of the facility's size is not at issue, the Department having failed to explicate its non-rule policy. Adopted in Finding of Fact 24, but otherwise rejected as cumulative and unnecessary. Adopted in Findings of Fact 9, 31, but otherwise rejected as unnecessary. Rejected in Findings of Fact 24, 33, 35, 39. The proposed average length of stay of one year is found to be reasonable in Finding of Fact 10. Adopted in Findings of Fact 21, 22. 79-81 Adopted in Findings of Fact 19, 23, but otherwise rejected as unnecessary and cumulative. Rejected as irrelevant and unnecessary. Adopted in Findings of Fact 11, 18, but otherwise rejected as unnecessary. Adopted in Finding of Fact 31. Rejected as unnecessary. Adopted in part in Findings of Fact 11, 26 but otherwise rejected as unnecessary. 87-88 Adopted in Finding of Fact 3. Rejected as irrelevant and unnecessary. Adopted in Findings of Fact 3, 44, but otherwise rejected as unnecessary and cumulative. Rejected as simply a summation of testimony and therefore unnecessary. Adopted in part in Finding of Fact 4, but otherwise rejected as unnecessary. Rejected as simply a summation of testimony and not a Finding of Fact. Rejected as unnecessary and simply a summation of testimony. 95-96 Rejected as irrelevant, unnecessary and in part simply a summation of testimony. 97-98 Rejected as a summation of testimony and otherwise as speculative and irrelevant. 99 Rejected as simply a summation of testimony. 100-103 Rejected as irrelevant. 104 Rejected as a summation of, and argument on, the evidence rather than a Finding of Fact. Rulings on the Proposed Findings of Fact filed by Manatee Palms: Adopted in Findings of Fact 1, 27. Adopted in Finding of Fact 2. Adopted in Finding of Fact 3. Adopted in Finding of Fact 4. Adopted in Finding of Fact 5. Adopted in Finding of Fact 6, but otherwise rejected as irrelevant. Adopted in part in Finding of Fact 7. Rejected as unnecessary, and as simply a statement of position. 9-11 Rejected as unnecessary and as otherwise covered in preliminary procedural matters. Adopted in Finding of Fact 8. Adopted in Finding of Fact 5, but otherwise rejected as unnecessary. Adopted in Finding of Fact 8. Adopted in Findings of Fact 9, 31, but otherwise rejected as simply a summation of testimony and position of the parties. Adopted in Finding of Fact 8. Adopted in Findings of Fact 10, 25, 39, 44. Adopted in Finding of Fact 14, but rejected in Finding of Fact 24. Adopted in Finding of Fact 17, but rejected in Finding of Fact 24. Rejected in Findings of Fact 21, 22, 23. Rejected as simply argument and a statement of position rather than a Finding of Fact. Adopted in part in Findings of Fact 25, 39. Rejected in Findings of Fact 21, 22, 23. 24-26 Rejected in Findings of Fact 19, 20, 23. Adopted in Findings of Fact 19, 44, but rejected in Finding of Fact 23. Rejected in Findings of Fact 23, 24. Adopted in Finding of Fact 17. Adopted in Findings of Fact 16, 17. Adopted in Finding of Fact 17. Rejected as unnecessary. Adopted in Finding of Fact 17. 34-42 Rejected as irrelevant and unnecessary. This is a de novo proceeding through which final agency action will be taken, and therefore preliminary agency findings are irrelevant to a determination of the issues in this case which must be decided based upon evidence presented at hearing. Rejected as simply a statement of position without any citation to the record. Adopted in Finding of Fact 24. 45-46 Rejected in Finding of Fact 24. 47-48 Adopted and rejected in part in Finding of Fact 24. 49-60 Rejected in Finding of Fact 24. Rejected as simply a conclusion of law. Rejected as without citation to the record and as simply a statement of position rather than a Finding of Fact. Rejected as irrelevant. Adopted in part in Finding of Fact 3. Adopted in Finding of Fact 3. 66-70 Rejected as unnecessary and cumulative, since it is established that services are similar or identical to those proposed by FRTC. Adopted in Findings of Fact 3, 44. Rejected as unnecessary and cumulative. Adopted in Finding of Fact 3, but otherwise rejected as cumulative and unnecessary. Rejected in Findings of Fact. 26, 39 and otherwise as irrelevant. Rejected as irrelevant and otherwise not based on competent substantial evidence. Rejected as irrelevant. Adopted in Finding of Fact 30. Rejected as simply a statement of position, without citation to the record. Rejected as simply a conclusion of law. 80-81 Adopted in part in Finding of Fact 8, but otherwise rejected as not based on competent substantial evidence. 82 Rejected as unnecessary. 83-84 Rejected in Findings of Fact 33 and 35, and otherwise as irrelevant. Rejected as simply a conclusion of law. Rejected in Finding of Fact 34. Adopted in Finding of Fact 37. Adopted in Findings of Fact 34, 36. 89-90 Rejected in Findings of Fact 35, 37. Rejected as simply a conclusion of law. Adopted in Finding of Fact 39. Rejected as irrelevant. Rejected in Findings of Fact 38, 39, 42. Adopted in Finding of Fact 39. Rejected as irrelevant. Adopted in part in Finding of Fact 39, but otherwise rejected as irrelevant and unnecessary. 98-100 Adopted in Finding of Fact 39. 101-102 Adopted in Findings of Fact 38, 39. 103-109 Rejected in Finding of Fact 39, and otherwise as not based on competent substantial evidence. Rejected in Findings of Fact 26, 29. Rejected in Finding of Fact 39. Rejected in Finding of Fact 35, and otherwise as irrelevant. Rejected in Findings of Fact 38, 39, 42. Adopted in Finding of Fact 39. 115-117 Adopted and rejected in part in Finding of Fact 40, but otherwise rejected as irrelevant. Adopted and rejected in part in Findings of Fact 8, 40, but otherwise rejected as not based on competent substantial evidence. Rejected in Findings of Fact 38-42. Rejected as a conclusion of law. Rejected as not based on competent substantial evidence. Adopted in Findings of Fact 34, 37. Adopted in Finding of Fact 36. Rejected as not based on competent substantial evidence. Adopted in part in Finding of Fact 45. Rejected as not based on competent substantial evidence and without citation to the record. Rejected as a conclusion of law. 128-129 Rejected as simply a comment on the evidence and not a Finding of Fact. Adopted in part in Finding of Fact 8. Rejected in Finding of Fact 47. Rejected as irrelevant. Adopted in part in Finding of Fact 8, but otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as simply a statement of position and argument. Rulings on Proposed Findings of Fact filed by Manatee Memorial: 1-2 Adopted in Finding of Fact 1. 3-4 Rejected as irrelevant. 5 Adopted in Findings of Fact 8, 29. 6-7 Rejected as irrelevant to a determination of the issues in this case. 8-10 Adopted in Finding of Fact 3. Adopted in part in Findings of Fact 34, 36, 45. Adopted in Finding of Fact 2. 13-22 Adopted in Finding of Fact 4, but otherwise rejected as irrelevant or unnecessary. Rejected in Finding of Fact 24 and otherwise rejected as not based on competent substantial evidence. Rejected as cumulative and unnecessary. Adopted in Findings of Fact 34, 36. Rejected as speculative and not based on competent substantial evidence. Rejected as irrelevant. Adopted in Finding of Fact 6. Adopted in Findings of Fact 1, 5, 10, but rejected in in Finding of Fact 44. 30-32 Adopted in Finding of Fact 6. 33 Adopted in Finding of Fact 7. 34-39 Rejected as unnecessary. Adopted in Finding of Fact 15. Adopted in Finding of Fact 14. Adopted in Finding of Fact 17. 43-45 Adopted in Finding of Fact 16. Rejected as unnecessary and irrelevant. Since Mr. Griffin is the highest level departmental representative who testified at hearing, his statement of the non-rule policy is presumed to be correct. Rejected in Finding of Fact 16. Rejected in Finding of Fact 16 and otherwise as unnecessary and irrelevant. 49-51 Rejected as irrelevant since this is a de novo hearing by which final agency action will be taken. Rejected as simply a conclusion of law. Rejected in Findings of Fact 21-23. Adopted in Finding of Fact 39. 58-60 Rejected in Findings of Fact 21-23 and otherwise as irrelevant. 61-63 Rejected in Findings of Fact 19, 20, 23. Adopted in Finding of Fact 30, but rejected in Finding of Fact 31. Rejected in Finding of Fact 39 and otherwise as irrelevant. Adopted in Finding of Fact 25 and rejected in Finding of Fact 26. Rejected in Findings of Fact 26, 39, 42. Adopted in part in Findings of Fact 38, 39, 44. Rejected in Findings of Fact 24 and 39. Rejected as speculative, and not based on competent substantial evidence. 71-79 Rejected in Findings of Fact 26, 38, 39 and otherwise rejected as not based on competent substantial evidence. 80-83 Rejected in Findings of Fact 33, 35. Rejected in Findings of Fact 33, 35, 38, 39, 42. Rejected in Findings of Fact 39, 40. Rejected in Findings of Fact 38-42. Rejected in Finding of Fact 37. Adopted in Finding of Fact 33. Rejected in Finding of Fact 33. Rejected in Finding of Fact 35. Rejected in Findings of Fact 27, 33, 35. Rejected in Finding of Fact 37. Rejected as unnecessary. 94-95 Rejected in Finding of Fact 37. 96 Adopted in Finding of Fact 36. 97-100 Rejected in Findings of Fact 28, 29. 101-102 Adopted in Finding of Fact 8. 103-105 Rejected in Finding of Fact 29. 106 Rejected in Finding of Fact 8. 107-109 Rejected in Findings of Fact 27, 28, 29 and otherwise not based on competent substantial evidence. 110 Rejected as irrelevant. 111-112 Rejected in Finding of Fact 9. Rejected in Findings of Fact 9, 27, 28, 29. Adopted in Finding of Fact 8. 115-116 Rejected as irrelevant. Adopted in Finding of Fact 8. Adopted in Finding of Fact 47. Adopted and rejected in Finding of Fact 47. Adopted in Finding of Fact 8 and rejected in Finding of Fact 47. Rejected as irrelevant. Adopted and rejected in Finding of Fact 47. Adopted in part in Findings of Fact 3, 4. Adopted in Findings of Fact 25, 39, 45. 125-127 Rejected as speculative and not based on competent substantial evidence. 128-130 Rejected as irrelevant and unnecessary. COPIES FURNISHED: John Rodriguez, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700 Michael J. Glazer, Esquire Post Office Box 391 Tallahassee, Florida 32302 Jean Laramore, Esquire Anthony Cleveland, Esquire Bruce A. Leinback, Esquire Post Office Box 11068 Tallahassee, Florida 32302 William Hoffman, Esquire Deborah Winegard, Esquire 2500 Trust Co. Tower 25 Park Place Atlanta, Georgia 30303 Fred W. Baggett, Esquire Stephen A. Ecenia, Esquire Post Office Drawer 1838 Tallahassee, Florida 32302 John T. Brennan, Jr., Esquire 900 Seventeenth Street, N.W., Suite 600 Washington, DC 20006 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700 John Miller, Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Fl 32399-0700 =================================================================
The Issue Whether Respondent, Dien Duong, violated the provisions of Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, as specifically alleged in the Administrative Complaint, and, if so, what penalty would be appropriate.
Findings Of Fact Based upon observation of the witnesses and their demeanor while testifying, the documentary evidence received, and the entire record compiled herein, the following material and relevant facts are found: Petitioner, Department of Health, Board of Medicine, is the state agency charged with regulating the practice of physician's assistants pursuant to Chapters 455 and 458, Florida Statutes, and Section 20.43, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician's assistant in the state of Florida, having been issued license number PA 0003211 in 1997. Respondent received a Bachelor's Degree in Biology from Hope College, Holland, Michigan, in 1989 and thereafter received her physician's assistant degree from Western Michigan University in 1991, and became certified in Family Practice and in Surgery in Michigan upon graduation. Respondent has maintained her certification in Family Practice and in Surgery by successfully passing an examination every six years since 1991, in addition to taking a minimum of 100 hours of Continuing Medical Education (CME) courses each year. In 1997 Respondent began working at South Florida Baptist Hospital Emergency Department and has maintained her employment in that department as a physician's assistant. During the course of her employment, Respondent has gained extensive experience in the practice of assessing lacerations and repairing lacerations of all types. Respondent is highly respected by her employing physician, Dr. Charles Eaves, and by her supervising physicians in the emergency department of the hospital. Respondent has never been the subject of discipline or corrective action regarding her professional job performance as a physician's assistant. A physician's assistant is a licensed health care professional who works under the supervision of a doctor. Typical protocol between the supervising doctor and the physician's assistant is for the physician's assistant to inspect and evaluate the patient, examine the injury, prepare the patient for treatment, consult with the supervising doctor, and thereafter administer treatment to the injury approved by the doctor, followed by after-care instructions to the patient. Based upon the testimony of the experts, the protocol between experienced physician's assistants and their supervising doctors is based upon the doctor's respect and confidence in the physician's assistant's abilities, competence, experience and work history. In these mutual trust and respect working relationships, protocol typically permits the physician's assistant to work relatively autonomously. Without involvement of the supervising doctor, the physician's assistant examines emergency room injuries; they often treat the injured patient, and thereafter present the patient's case treatment and the patient's medical record to the supervising doctor for approval and, when recommended, signature for prescribed medication. The protocol between Respondent and her supervising physician, Dr. Diaz, at South Florida Baptist Hospital on May 8, 1998, was that of mutual trust. Patient D.Z. was a 33 year-old male who had fallen from a ladder and, while attempting to break his fall with his right hand, suffered a blunt, T-shaped, tear-like laceration injury to his right hand. The injury was on the palmar aspect in the area of the fifth metacarpal of the hand-bone that extended to the small finger; a complex laceration, described by doctors as a "sort of bust or blunt type," as opposed to a clean knife cut type, approximately 3/4 centimeter in depth. On May 8, 1998, D.Z. presented himself to the South Florida Baptist Hospital (Hospital) emergency room for treatment of his right hand laceration that extended to the subcutaneous level with subcutaneous tissue exposure. The Hospital's triage nurse, after completing preliminary patient information, directed D.Z. to First Care, that part of the hospital's emergency department where Respondent was working. Respondent, following protocol, examined D.Z.'s injured right hand and ordered x-rays to be taken. An x-ray was taken of D.Z.'s right hand and was reviewed by Respondent's supervising physician, Dr. Diaz, prior to treatment of the injury by Respondent. Dr. Diaz concluded that D.Z.'s x-ray was negative, with no broken bones or tendon involved. The medical records noted that D.Z. had the full range of motion of his fingers without numbness or tingling at that time. Respondent's treatment of D.Z. consisted of laying D.Z. on his back with his arm out to his side and using local anesthesia to numb the injured area. After numbing the hand, she infiltrated the wound with one percent plain Lidocaine, irrigated the wound with normal saline, and cleaned the wound with Betadine. She then debrided the tissue. Using sterile techniques, Respondent proceeded to suture the T-shaped laceration of D.Z.'s right hand. Because of the shape and depth of the laceration and because of the exposure of jagged-edge tears to the subcutaneous tissues, Respondent placed four subcutaneous sutures with 4.0 vicryl, an absorbable suture, in order to bring and keep the jagged-edged tears of D.Z.'s laceration together. For the type of wound suffered by D.Z., described as "bust-type-ripping-flesh tear," it is not possible to close a three or four centimeter wound with only surface sutures. Subcutaneous sutures are required for those wounds of this type and depth. For these reasons and acting appropriately within the scope of the practice of an experienced physician's assistant, Respondent determined to use subcutaneous sutures on D.Z., who is right-hand dominate. The experts who testified, Dr. Eaves, Dr. Solomon, Dr. Maddalon and Ms. Vergara, agreed that the process of using subcutaneous sutures helps to control bleeding, reduce tension within the laceration, and minimize potential "air pockets" within the wound, thereby promoting the healing process, and preventing potential, after-surgery, complications. In accord with protocol established between Dr. Diaz and Respondent, it was at the conclusion of her treatment care of D.Z. that she advised Dr. Diaz of her subcutaneous suture treatment and follow-up care plan. Respondent presented D.Z.'s record for his review, approval and signature. Dr. Diaz approved Respondent's subcutaneous suture treatment, her follow- up care plan of keeping the wound clean, taking the prescribed medication and having the sutures removed within a few days during his follow up a doctor of his choice. Dr. Diaz signed both the Emergency Room report and Respondent's suggested prescription medications for D.Z. On May 11, 1998, four days after his treatment and without obtaining and taking his prescription medications as instructed, D.Z. presented himself to Dr. Maddalon's office for a follow-up examination and evaluation of his injury. On May 14, 1998, Dr. Maddalon, who employed D.Z.'s mother as his office manager and had employed D.Z. for six years to clean his office and who had operated and treated D.Z.'s right hand for carpal tunnel syndrome some years earlier, examined D.Z.'s right hand following an earlier examination by his physician's assistant. On May 15, 1998, during exploratory surgery, Dr. Maddalon reopened the laceration of D.Z.'s right hand and observed that a subcutaneous suture had passed through the ulnar nerve and tied the ulnar digital nerve to the adjoining soft tissue. He removed the subcutaneous suture and removed the damaged part of the ulnar nerve. He then re-attached the exposed ends of the ulnar nerve. D.Z. recovered satisfactorily from Dr. Maddalon's surgery with most but not all of the sensation returning to the little finger on his right hand. According to his deposition, and without a review of D.Z.'s medical records from South Florida Baptist Hospital emergency room prepared by Respondent, Dr. Maddalon opined that certain protocol should be followed in treating "blunt-tear" type hand injuries like that suffered by D.Z. Dr. Maddalon went on to stress, however, that in his opinion placing subcutaneous sutures in such an injury as D.Z.'s was not below the standard of care for a physician's assistant. Deborah Vergara, a physician's assistant at Town and Country Hospital, Tampa, Florida, qualified as an expert in physician's assistants' duties, responsibilities and protocol, and after reviewing D.Z.'s medical records, opined that the care provided D.Z. by Respondent during treatment on May 8, 1998, was appropriate for a patient with D.Z.'s type laceration and was not below the standard of care for a physician's assistant. Deborah Vergara further opined that a suture passing through the ulnar nerve, in and of itself, is not a breach of the standard of care, and she was not aware of any textbooks for physician's assistants that prohibited ever placing subcutaneous sutures in a laceration. Dr. Charles Eaves, D.O., an expert in emergency medicine and an expert in supervising physician's assistants and who also has been the supervising doctor of South Florida Baptist Hospital for the past three years, opined that Respondent's placing subcutaneous sutures in a palmar laceration was absolutely within the standard of care. Dr. Eaves further opined that Respondent's entries in D.Z.'s medical records were within the standard of care. Dr. Barry Solomon, Board Certified expert and employed by the Physician Health Care Alliance in Clearwater, Florida, after review of all of D.Z.'s medical records from South Florida Baptist Hospital, the Administrative Compliant filed in this case, Dr. Maddalon's deposition, and records from Brandon Regional Medical Center, gave his opinions in the following areas: Protocol of supervising physician and physician's assistants working in specific areas of medicine. According to Dr. Solomon, physician's assistants generally operate with relative autonomy, based upon the experience of the assistant and the confidence of the supervising physician. Physician's assistants see low acuity patients, leaving the physician to see high acuity patients. Physician's assistants do check with the physician on duty as they proceed through treating a patient, checking to make sure what they are going to do is appropriate and have the physician review and sign the chart as the patient is being made ready for discharge. Protocol for physician's assistants suturing palmar lacerations. Dr. Solomon opined that Respondent's conduct when presented with a patient with a palmar laceration in a subcutaneous area with an abnormal, complex laceration, and after assessment for nerve damage, tendon damage, bone injury, and after obtaining an x-ray which was reviewed by the emergency room physician at the time, and then proceeding to place a two- layer closure consisting of four subcutaneous sutures and eleven external sutures to close the wound, was within the standard of care of physician's assistant, in this case, the Respondent. Dr. Solomon further opined that there is nothing wrong with placing subcutaneous sutures in a hand laceration and there is always a risk, with a deep wound that nerves, blood vessels, arteries and veins could potentially be hit or sutured. This risk is a recognized complication when one places subcutaneous sutures in that (hand) part of the body. He concludes that Respondent practiced within the physician assistant's standard of care in her subcutaneous suture treatment of Patient D.Z.'s right hand. Petitioner has failed to provide the opinion of an expert that establishes a standard of care for an experienced physician's assistant; has failed to provide evidence of standard of care for maintaining medical records; and has failed to provide an expert opinion in support of the allegation that Respondent's treatment of D.Z.'s right hand laceration fell below a physician's assistant standard of care for treatment of hand lacerations. The testimony of Dr. Charles Eaves, Dr. Barry Solomon and Deborah Vergara is credible in establishing that Respondent, Dien Duong, actions were not violations of Subsection 548.331(1)(m) and 488.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty of violating Subsections 458.331(1)(m) and (t), Florida Statutes. DONE AND ENTERED this 2nd day of May, 2002, in Tallahassee, Leon County, Florida. FRED L. BUCKINE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of May, 2002.
The Issue Whether Respondent, a physician, violated the provisions of Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, as alleged in the administrative complaint and the penalties, if any, that should be imposed.
Findings Of Fact At all times pertinent to this proceeding, Respondent was licensed as a physician in the State of Florida and held medical license number ME00597713. Respondent graduated from medical school in the Dominican Republic in 1981. Subsequent to medical school, Respondent completed a year residency at St. Clare's Hospital and Memorial Center in New York City, which was affiliated with New York Medical College. Respondent completed a second year of surgical residency at University of Miami, Jackson Memorial Hospital. Respondent then completed one year of flexible residency and three years of internal medicine residency at Mercy Catholic Medical Center, which was affiliated with Thomas Jefferson University in Philadelphia, Pennsylvania. Respondent has practiced as an emergency medicine physician since 1988. Respondent has served as the medical director of the emergency department of Palm Springs General Hospital, Hialeah, Florida, since 1990. At the times pertinent to this proceeding, Respondent was not board certified in any specialty. The administrative complaint centers on Respondent's treatment of patient R. A., a 48 year old male, at the Palm Springs emergency room on December 24, 1991. EMERGENCY ROOM TREATMENT ON DECEMBER 23, 1991 R. A. presented to the Palm Springs emergency room on December 23, 1991, at 3:50 p.m., via ambulance. He complained of severe epigastric pain over the past 24 hours that radiated to the right quadrant of his back. His blood pressure reading was 230 over 110. R. A. reported that he smoked a pack of cigarettes a day, did not drink alcohol, and had no allergies. R. A. also reported that he had not been vomiting. On December 23, 1991, R. A. was treated by Dr. Wilfred P. Fernandez, an emergency room physician employed by Palm Springs. Dr. Fernandez took the patient's medical history and then proceeded with his physical examination. The examination of the head, ears, eyes, nose, and throat were within normal limits. The lungs were clear and the heart rate and rhythm were regular. The abdominal evaluation demonstrated positive bowel sounds and positive epigastric tenderness. There was no guarding or rebound tenderness. A rectal exam revealed there was no blood in the stool. The extremity evaluation was within normal limits, as was the neurological evaluation. Dr. Fernandez ordered several diagnostic studies, including a complete blood count, an EKG, chest x-ray, abdominal film, and gallbladder sonogram. For reasons that were not made clear, the gallbladder sonogram was not performed. All other diagnostic tests were unremarkable. At 4:45 p.m. on December 23, 1991, Dr. Fernandez prescribed the following medications for R. A.: Donnatal, Maalox, Procardia, and Reglan. Donnatal contains a mild sedative and belladonna contains alkaloids to treat spasms. Maalox is an anti-acid. Procardia contains a channel blocker and was used to treat his hypertension. Reglan was administered via IV to clear R. A.'s bowels. R. A. was discharged from the Palm Springs emergency room at approximately 6:30 p.m. on December 23, 1991. On discharge, Dr. Fernandez gave R. A. a tablet of Clondine for his hypertension and prescriptions for Clondine 1 mg. and Zantac 150 mg. Dr. Fernandez instructed R. A. not to smoke, not to drink, and not to operate dangerous machinery while on the prescribed medication. R. A. was instructed to see his personal physician or return to the emergency room if his condition worsened. R. A. did not have his prescription for Clondine or for Zantac filled before his second admission to Palm Springs emergency room on December 24, 1991. EMERGENCY ROOM TREATMENT ON DECEMBER 24, 1991 On December 24, 1991, R. A. presented to Palm Springs emergency room for the second time. R. A. was transported to the emergency room by Hialeah Fire Rescue and arrived at approximately 6:05 p.m. On arrival, R. A. complained of epigastric pain. His vital signs at 6:10 p.m. included his blood pressure reading of 230 over 130. The nurses notes for this visit reflect that the patient had been seen the day before and had received a GI (gastrointestinal) cocktail, which is a reference to the concoction given to him to relieve his epigastric pain. Respondent treated R. A. while he was at the Palm Springs emergency room on December 24, 1991.1 At 6:20 p.m., Respondent performed his initial evaluation of R. A. Respondent took a history from the patient and observed the patient's appearance and composure. R. A. reported that he had not filled his prescriptions from the prior day. He reported to Respondent that he had epigastric pain in the mid-epigastric region that had been ongoing for several days. R. A. also reported that the medications he had received the previous day had helped him. Respondent noted the initial blood pressure on admission and that the patient had not filled his prescription for Clondine. Respondent discussed with R. A. the importance of taking Clondine for his hypertension. After observing the patient initially and obtaining a history, Respondent requested the emergency room records for R. A. from the previous day. He noted that Dr. Fernandez diagnosed the patient's condition as dyspepsia and hypertension. He also noted the laboratory and radiological studies that had been ordered, including that a gallbladder ultrasound had been ordered. The records did not at that time indicate that the gallbladder ultrasound had not been performed. Respondent discussed R. A.'s prior visit with an emergency room nurse who had participated in his treatment on December 23, 1991. The nurse told Respondent that all tests were normal. Respondent understood from what the nurse had told him that the gallbladder ultrasound was also normal. It is common practice for an emergency room doctor to rely on such statements from an emergency room nurse. Respondent thereafter performed an appropriate physical examination of R. A. The patient's eyes were found to be slightly jaundiced (icteric), which was a factor in leading Respondent to suspect that the patient may have had an illness affecting his liver, such as hepatitis. The abdominal evaluation revealed epigastric tenderness on palpation but no rebound. The patient's blood pressure was elevated. All other physical findings were within normal limits. A consistent blood pressure of 230 over 130 or higher is considered hypertension that warrants treatment before discharge. Labile hypertension is the acute elevation of blood pressure caused by anxiety, stress, or pain. Labile hypertension will often resolve itself without treatment once stressors or pain is resolved. A patient with a blood pressure of 230 over 130 who is suspected of suffering labile hypertension should have his blood pressure checked no less than every fifteen minutes to observe whether the hypertension resolves itself. Based on the patient's history and his evaluation and observation of the patient, Respondent determined that R. A. was more likely suffering from labile hypertension than from an emergent condition that warranted emergency treatment of the patient's hypertension. Respondent thereafter administered to the patient what was referred to as a GI cocktail to relieve his epigastric distress. The GI cocktail consisted of Zantac, Connatal, and Viscous Lidocaine and was administered at approximately 6:30 p.m. Respondent believed it likely that the GI cocktail would reduce the patient's pain and result in a lowering of the patient's blood pressure. The emergency room staff checked R. A.'s blood pressure every fifteen minutes and advised Respondent of the readings. Respondent ordered additional tests to evaluate whether the patient's epigastric pains were symptoms of a condition that required emergency care. Respondent ordered a complete blood count, a liver profile, and EKG and an abdominal x-ray. The blood studies came back within normal limits. The liver profile indicated an elevation of serum bilirubin as well as an elevation of the liver enzymes. All other tests were within normal limits. The GI cocktail relieved most of R. A.'s epigastric pain. Because he had lingering discomfort, Respondent administered a small dose of Demerol and Vistaril, which completely relieved R. A.'s pain. Respondent determined that R. A. was not suffering from a condition that required emergency care. He formed the opinion that the patient had hepatitis, but that his condition did not require immediate hospitalization. At approximately 9:00 p.m., R. A. was discharged from the Palm Springs emergency room. At the time of his discharge, R. A.'s blood pressure was approximately 160 over 80, which is within acceptable limits. Prior to his discharge, Respondent spoke with the physician who he thought would be following R. A.'s condition. This physician had treated R. A.'s wife, but he had not treated R. A. The patient was also given the name of a doctor who was on the hospitals primary physician call list. Also prior to discharge the patient was instructed not to drink any alcohol while taking his medication, to fill his prescriptions for Zantac and Clondine, and to follow-up with his primary care physician in three to four days. He was also instructed to eat lightly and increase fluid intake. Respondent told R. A. to return to the emergency room or go to his primary physician if his condition worsened. Respondent's care and treatment of R. A., including his determination that the patient did not require further emergency treatment did not fall below the standard of care imposed on emergency room physicians. As will be discussed below, his diagnosis of hepatitis was incorrect. The testimony of Dr. Dellerson established that the incorrect diagnosis did not fall below the standard of care imposed on emergency room physicians. THE MEDICAL RECORDS FOR DECEMBER 24, 1991 R. A.'s records for the emergency room visit to Palm Springs on December 24, 1991, indicate that his blood pressure reading at 6:45 p.m. was 230 over 170. This is the last recorded blood pressure reading for R. A. on December 24, 1991. Respondent testified, credibly, that R. A.'s blood pressure was checked approximately every 15 minutes and that his blood pressure came down to an acceptable level during the course of his emergency room stay on December 24, 1991,2 but that the records do not reflect those blood pressure readings. While it was the emergency room nurse's responsibility to take and to record that blood pressure, Respondent had the ultimate responsibility for the records as the treating physician. Although Respondent's practice did not fall below the standard of care imposed on emergency room physicians, the records that were kept were inadequate to reflect the patient's condition or to justify the Respondent's course of treatment.3 EMERGENCY ROOM TREATMENT ON DECEMBER 25, 1991 On December 25, 1991, R. A. presented to Jackson Memorial Hospital at approximately 2:10 p.m. He complained of epigastric pain that radiated to his back. He had vomited earlier that morning and had noticed blood in his vomit and blood in his stool. These were complaints and symptoms that were not present the day before. At the time of his presentation, his blood pressure was 160 over 110. The following day a CT scan was performed that led to a diagnosis of gall stones in the gallbladder and in the distal common bile duct, which did not require emergency surgery. R. A. was also diagnosed as having suffered a recent hypertensive stroke. This stroke most likely occurred after the patient presented at Jackson Memorial Hospital.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order that dismisses count one of the Administrative Complaint, but finds Respondent guilty of violating Section 458.331(1)(m), Florida Statutes, as alleged in count two of the Administrative Complaint. It is further recommended that Respondent be reprimanded and assessed an administrative fine in the amount of $250.00. DONE AND ENTERED this 14th day of July, 1997, in Tallahassee, Leon County, Florida. Hearings Hearings CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative this 14th day of July, 1997
The Issue Whether Rule 64B8-9.009(6)(b)1.a., Florida Administrative Code, is an invalid exercise of delegated legislative authority pursuant to Section 120.52(8), Florida Statutes.
Findings Of Fact Stipulated Facts Section 458.331(1)(v), Florida Statutes, authorizes the Board to adopt rules establishing the standards of practice and care for particular physician practice settings. The Board is the agency that adopted Rule 64B8-9.009, Florida Administrative Code, regarding standards of care for office surgery. Petitioner, Victor Ortiz, is a Certified Registered Nurse Anesthetist (CRNA), and is licensed by the Board of Nursing pursuant to Chapter 464, Florida Statutes. Mr. Ortiz is not a member of the Florida Association of Nurse Anesthetists or the Florida Nurses Association. Mr. Ortiz provides anesthesia care to patients in various settings under the supervision of physicians licensed pursuant to Chapters 458 and 459, Florida Statutes. Among other functions, Mr. Ortiz orders preanesthetic medications; administers regional, spinal, and general anesthesia under protocol and the supervision of a physician; provides life support functions; and monitors patient condition during surgery and in the recovery room. Prior to April 15, 2002, the effective date of Rule 64B8-9.009(6)(b)1.a., Florida Administrative Code (the Rule), Mr. Ortiz administered anesthesia under the supervision of operating physicians for all types of office surgeries, including surgical procedures classified by the Board of Medicine as "level III." Mr. Ortiz provided anesthesia services to patients in level III office surgeries under the supervision of M.D. or D.O. operating physicians four or five days per week on average. The Rule requires that if the anesthesia provider is a CRNA, there must be a licensed M.D. or D.O. anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia in level III office surgeries. Since the adoption of the Rule, the physicians for whom Mr. Ortiz previously provided anesthesia services will no longer employ him for level III office surgeries because they believe that it is unnecessary and cost-prohibitive to pay Mr. Ortiz to provide the actual anesthesia services and an anesthesiologist to directly supervise him. Consequently, Mr. Ortiz' revenues have been reduced and his office practice has been substantially and adversely affected.
The Issue The issues in the case are whether certain provisions of the Florida Medicaid Hospital Services Coverage and Limitations Handbook (Handbook) that exclude non-emergent services rendered in the emergency room from covered Medicaid outpatient services and require revenue Code 451 to be billed with CPT Code 99281 constitute an invalid exercise of delegated legislative authority within the meaning of Subsection 120.56(3), Florida Statutes (2010).1
Findings Of Fact AHCA is the Medicaid agency for the State of Florida as provided under federal law. § 409.901(2), Fla. Stat. “'Medicaid agency' . . . means the single state agency that administers or supervises the administration of the state Medicaid plan under federal law." § 409.901(15), Fla. Stat. AHCA must administer the Medicaid program pursuant to a state plan that is approved by the Center for Medicare and Medicaid Services (CMS). 42 U.S.C. §§ 1396 and 1396a(a). AHCA reimburses Medicaid providers in accordance with state and federal law, according to methodologies set forth in rules promulgated by AHCA and in policy manuals and handbooks incorporated by reference in the rules. AHCA has adopted Florida Administrative Code Rule 59G-6.030, which incorporates by reference the Florida Title XIX Outpatient Hospital Reimbursement Plan, Version XIX (the Outpatient Plan), with an effective date of July 1, 2009. Reimbursement to participating outpatient hospitals, such as Petitioners, is to be provided in accordance with the Outpatient Plan. AHCA has issued the Florida Medicaid Hospital Services Coverage and Limitations Handbook. The Handbook is incorporated by reference in Florida Administrative Code Rule 59G-4.160. The Outpatient Plan and the Handbook identify those outpatient hospital services that are covered by the Medicaid program by revenue code. Only those revenue codes listed in Appendix A of the Outpatient Plan (Appendix A) and Appendix B of the Handbook (Appendix B) are covered outpatient services. Petitioners have challenged the following provisions of the Handbook: Handbook at page 2-7: EMTALA Medical Screening Exam The federal Emergency Medical Treatment and Labor Act (EMTALA) requires emergency rooms to conduct a medical screening exam on any patient presenting to the emergency room for medical services . . . . If the medical screening exam determines that no emergency medical condition exists, Florida Medicaid reimburses only for the screening and the ancillary services required to make the determination (e.g., lab work or x-rays). Medicaid policy does not provide for reimbursement of non-emergency services beyond the medical screening exam required by EMTALA. Handbook at page 2-40: Non-Emergency Care in the Emergency Room Medicaid policy does not provide for reimbursement of non-emergency services beyond the medical screening exam required by Emergency Medical Treatment and Labor Act (EMTALA). EMTALA requires emergency rooms to conduct a medical screening exam on any patient presenting to the emergency room for medical services. The purpose of the medical screening exam is to determine if an emergency medical condition exists. If the screening determines that an emergency medical condition exists, the provider must either stabilize the condition or appropriately transfer the patient to a facility that can stabilize the condition. If the medical screening determines that no emergency medical condition exists, Florida Medicaid reimburses only for the screening and the ancillary services required to make the determination (e.g., lab work or x-rays). Recipients are responsible for a coinsurance on such claims. Handbook, Appendix B at pages B-6 and B-7: EMERGENCY ROOM 0450 General Classification Use General Classification code 0450 when recipients require emergency room care beyond the EMTALA emergency medical screening services. Code 0450 cannot be used in conjunction with 0451 (99281). All other appropriate and covered outpatient revenue codes can be billed with 0450 to reflect services rendered to the patient during the course of emergency room treatment. No MediPass authorization is required when billing 0450, if the type of admission in Form Locator 19 on the claims is "1" (Emergency). MediPass authorization is required when the condition of the patient is not an emergency. 0451(99281) EMTALA Emergency Medical Screening Services (Effective 7/1/96) Report the EMTALA Medical Screening code 0451 (99281) when, following the screening and exam, no further emergency room care or treatment is necessary. If ancillary services are not necessary to determine whether or not emergency or further treatment is required, report the ancillary charges using the appropriate revenue center codes in conjunction with code 0451 (99281). Note that 0451 (99281) cannot be used in conjunction with 0450. Effective 10/16/03, HCPCs code 99281 replaces code W1700, used prior to 10/16/03, when billing revenue code 0451. Florida Administrative Code Rule 59G-4.160 provides that the specific authority for the promulgation of the rule is Section 409.919, Florida Statutes, and the law implemented is Sections 409.905, 409.908, and 409.9081, Florida Statutes. Petitioners are acute care hospitals that are and were enrolled as Medicaid providers of outpatient service in Florida at all times material to this proceeding.
Findings Of Fact The Respondent, Barbara Barlow, is a licensed practical nurse holding License No. 41347-1 issued by the Florida State Board of Nursing. During the month of November, 1978, Respondent was employed as a licensed practical nurse at West Florida Hospital, Pensacola, Florida. Prior to November, 1978, Respondent underwent a formal orientation program given by the hospital, which program included medication procedures for West Florida Hospital. Subsequent to that formal orientation program, Respondent received additional orientation with respect to medication procedures from Carrie Miller, an experienced licensed practical nurse working at West Florida Hospital on the same shift as the Respondent. Respondent was additionally counseled by Beverly Everitt, Respondent's head nurse, regarding medication procedures. Respondent's explanation for the errors alleged in Paragraphs 1(c) and 1(d) of the Administrative Complaint was vague and uncorroborated by either live testimony or the patients' medical records, which were received into evidence. Further, Respondent's explanation failed to withstand cross-examination. Respondent was terminated from her position at West Florida Hospital for having committed an excessive number of medication errors.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Board enter its final order finding Respondent, Barbara Barlow, guilty of unprofessional conduct based upon each and every allegation contained in the Administrative Complaint and placing the license of Respondent to practice nursing in the State of Florida on probation for a period of one year with the specific term and condition of said probation being that Respondent, during the period of probation, enroll in and successfully complete a course in the administration of and charting of medications by a nurse. RECOMMENDED this 20th day of May, 1980, in Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1107 Blackstone Building 223 West Bay Street Jacksonville, Florida 32202 Joseph L. Hammons, Esquire 412 West Gregory Street Pensacola, Florida 32501 Ms. Barbara Barlow Route 2, Box 129 Milton, Florida 32570 Ms. Geraldine B. Johnson, R.N. Supervisor I, Office of Investigations Region II Florida State Board of Nursing 111 East Coastline Drive Jacksonville, Florida 32292 Ms. Nancy Kelley Wittenberg, Secretary Department of Professional Regulation The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301
Findings Of Fact Good Samaritan Hospital, Inc. d/b/a Good Samaritan Medical Center ("Good Samaritan") is a 341 bed not-for-profit community hospital in West Palm Beach, established over 73 years ago. West Palm Beach is located in Agency for Health Care Administration ("AHCA") District 9. Its services include obstetrics and neonatal, medical and pediatric intensive care. Good Samaritan also opened an outpatient cardiac catheterization ("cath") laboratory of 1399 gross square feet, approximately two weeks prior to the start of the final hearing in this case. The establishment of an outpatient laboratory does not require a certificate of need. At the time the final hearing commenced, two procedures had been performed in the Good Samaritan outpatient cath lab. Written protocals exist for transfers to facilities with open heart surgery programs. Here, Good Samaritan is an applicant for a certificate of need ("CON") to provide adult inpatient cardiac cath services in the same cath lab. AHCA is the state agency which administers CON laws in Florida. AHCA published, on August 7, 1992, a fixed need pool showing a net need for two additional cardiac cath programs in AHCA District 9. On January 11, 1993, AHCA issued a State Agency Action Report ("SAAR") preliminarily approving Good Samaritan's CON. St. Mary's Hospital, Inc. ("St. Mary's") is a 430 bed hospital with acute care, psychiatric, and Levels II and III neonatal intensive care beds, located in West Palm Beach, Florida in AHCA District 9. St. Mary's is located 3 miles, or a 5 to 7 minute drive from Good Samaritan, and is an existing provider of adult inpatient cardiac cath services. Open heart surgery services are not available at St. Mary's. Palm Beach Gardens Community Hospital, Inc. ("Palm Beach Gardens") also in AHCA District 9, is located approximately a 25 minute drive from St. Mary's. Palm Beach Gardens' services include adult inpatient cardiac cath in a two room laboratory, and open heart surgery. There are eleven cath labs in District 9. Palm Beach Regional, Lawnwood in St. Lucie County, and a doctor in Martin County operate outpatient facilities. Five hospitals serve inpatients and outpatients - Boca Raton, St. Mary's, Martin Memorial, Bethesda, and Indian River. Three others, Palm Beach Gardens, JFK Medical Center and Delray Community Hospital, have cardiac cath labs at hospitals which also provide open heart surgery services. By prehearing stipulation, the parties agreed that the historical quality of care at Good Samaritan is not at issue. Palm Beach Gardens asserts that Good Samaritan's application was incomplete. Application Content Submitted with the Good Samaritan application was a certificate of the custodian of its records which relied on an April 20, 1989 resolution of Good Samaritan's Board of Directors as authorization for the filing of ". . . an application as described in the Letter of Intent." On August 25, 1989, Good Samaritan filed a letter of intent, with the Board's April 20, 1989 resolution, announcing its intent to apply on September 27, 1989, to establish inpatient cardiac cath and open heart surgery services, and to convert ten medical/surgical beds to intensive care beds for an estimated capital cost of $4,950,000. The 1989 resolution has not been withdrawn. The President of Good Samaritan, William J. Byron, testified that Good Samaritan never filed a joint application for cardiac cath, open heart surgery and intensive care beds, as described in the 1989 letter of intent. Good Samaritan also, he testified, never filed an application for cardiac cath services in 1989, but did file cardiac cath applications in 1990, and 1991 and the one at issue, in 1992. In February 1991, Good Samaritan's Board passed a resolution authorizing the filing of a CON application for inpatient cardiac cath services. Mr. Byron considered that resolution a reaffirmation of the 1989 resolution and decided to file the 1989 resolution with this application. The predecessor of AHCA initially notified Good Samaritan that the 1989 letter of intent for combined services was rejected. Subsequently, in November 1989, Good Samaritan was notified that the initial rejection applied to open heart surgery, because these were competing applicants, but that it would extend a grace period to apply for cardiac cath services to October 27, 1989, due to the absence of any competing applicants. What was intended in the letter which postdated the date it gave for the grace period was not established. Mr. Byron testified that Good Samaritan filed the February 1990 application, referencing the 1989 resolution, in accordance with the agency's grant of a grace period. Need For the Subject Project In August 1992, AHCA published its finding that a numeric need exists for two additional adult inpatient cardiac cath programs in District 9, by July 1995. The 1990-1991 local health plan for District 9 includes two factors for determining need and for allocating CONs for cardiac cath and open heart surgery services. The first District 9 factor favors facilities with an historical record of or commitment to serving Medicaid and indigent, handicapped or other underserved population groups. Good Samaritan's service to Medicaid patients increased from .2 percent in 1985 to 1.1 percent in 1989, then from 5.0 percent in 1990 to 11.2 percent of total admissions in 1992. Mr. Jay Cushman testified that the Medicaid commitment and record may be evaluated by comparing Good Samaritan to St. Mary's because they share a medical service area. Medicaid admissions to St. Mary's were 7.7 percent in 1985, 17.5 percent in 1989, 19.7 percent in 1990, and 32.0 percent in 1992. Therefore, as Mr. Cushman observed, the widening gap in the same service area is not indicative of Good Samaritan's historical record or present commitment to serve Medicaid patients. The District 9 plan also gives priority to applicants who propose to establish inpatient cardiac cath and open heart surgery services at the same facility when both are needed. The preference is inapplicable to the review of this application cycle, because no need was published for additional open heart surgery services in the district. There was testimony that Good Samaritan was, at the time of hearing, an applicant for an open heart surgery CON, having applied in March 1993, and had been preliminarily denied. The preference statement that an applicant "would not be expected to have to apply for both" describes the situation at the time of Good Samaritan's application. Therefore, the preference neither supports nor detracts from this application. The 1989 State Health Plan contains a similar preference for an applicant proposing both cardiac cath and open heart surgery services in response to a publication of the need for both. To have any practical effect in a comparative review process, avoiding speculation on the outcome of other pending administrative cases, the preference has to be understood to favor an applicant for cardiac cath and open heart surgery over an applicant for only cardiac cath in the same batching cycle. Therefore, the preference is inapplicable to this application for cardiac cath services, despite evidence of an open heart surgery application in a subsequent batching cycle. The state preference for the establishment of a new cardiac cath program in a county without such programs is not met. See, Findings of Fact 5. The state plan preference for disproportionate share charity care and Medicaid providers does not support approval of the Good Samaritan application. See, Finding of Facts 16, supra. The state preference for hospitals which accept patients regardless of ability to pay is met by Good Samaritan. On balance, there is no showing of the need for Good Samaritan's proposal to advance the special interests identified in the state and District 9 health plans. Good Samaritan argues that its inpatients should have access to its new, state-of-the-art cath lab to avoid costs and disruptions associated with unnecessary transfers. The argument is rejected as inconsistent with the regulatory scheme and need criteria established by statutes and rules. Testifying about AHCA's preliminary approval of Good Samaritan's application, Good Samaritan's expert, Ronald Luke, Ph.D., described the objective as improving access to care for the underserved, meaning uninsured, because ". . . there is no question - - no question - - that there is sufficient physical capacity in the market to perform the projected number of caths . . ." Transcript, Vol. 9, p. 1154. At hearing, David Musgrave, Good Samaritan's financial officer, and Dr. Luke asserted that Good Samaritan would perform caths on 100 more indigents than originally represented in the application. The application projected 3 percent indigent and 2 percent Medicaid payer categories. In the pro forma marked as exhibit 39, Good Samaritan projected 2.7 percent indigent care. There is no credible evidence to demonstrate that Good Samaritan can recruit an additional 100 indigent cardiac cath patients, through contacts with public health agencies. Utilization Projections Two major issues in dispute, which partially depend on the accuracy of utilization projections, are the requirements of Rule 59C-1.032(8)(b) that an applicant reasonably project 300 cath lab visits within two years of operation, and the long-term financial feasibility of the proposal. According to Dr. Luke, the 300 minimum annual procedures for a cath lab and 150 for invasive cardiologists who perform caths are standards set by the American College of Cardiology and American Heart Association Guidelines for Cardiac Catherization and Cardiac Catheterization Laboratories. The standards are set to insure that sufficient numbers of procedures are performed to maintain staff and cardiologists' proficiency. Good Samaritan's application includes projections of 270 caths in year one and 360 in year two. Initially, a minimum of 119 caths is reasonably expected, based on that number of inpatients transferred in 1992 from Good Samaritan for cath inpatient procedures at other hospitals. The experts for Good Samaritan compare its proposal to the operations of the cath lab at Boca Raton Community Hospital ("Boca Raton"), which has no open heart surgery services and a closed in-house cathing staff. A "closed staff" limits those who perform cath lab procedures to invasive cardiologists based at the facility. After opening in October 1987, Boca Raton has had the following number of cath procedures performed at its hospital: 1988 1989 1990 1991 1992 621 658 644 530 487 Like Boca Raton, Good Samaritan also proposes to have a closed lab. It will be headed by a hospital-employed physician. An agreement with the medical school at Duke University will allow the staff cathing physician to maintain the necessary personal clinical skills by performing sufficient numbers of additional procedures at Duke. Good Samaritan shares its medical staff and medical service area with St. Mary's. St. Mary's experts project that Good Samaritan would be another low volume provider in the area, primarily due to the lack of back-up open heart surgery services. Volumes of cath procedures reported at St. Mary's, which opened in February 1988, are as follows: 1988 1989 1990 1991 1992 229 292 323 381 359 St. Mary's has an open cathing staff. Its lab is used by a number of different invasive cardiologists, who also practice primarily at other hospitals which have open heart surgery services available. Palm Beach Gardens also has an open cardiac cath staff, although a number of the cathing physicians are based at the hospital. However, Palm Beach Gardens also has open heart surgery services. It's volumes from 1988-1992 were as follows: 1988 1989 1990 1991 1992 1598 1392 1587 1824 1750 Clearly, both the presence or absence of open heart surgery and the internal operations of a lab affect the volumes of procedures performed at any cardiac cath lab. The greater weight of the evidence suggests that the presence of open heart surgery is more determinative of cath lab utilization than the internal operations of the cath lab. Despite evidence of increasing use rates in District 9, Good Samaritan has failed to demonstrate that its projected utilization is reasonable. All of the growth in volume in Palm Beach County in 1992 is attributable to JFK Medical Center and Delray Community Hospital, both of which have open heart surgery and to Bethesda, with a new program in 1992 and 249 procedures. Declines in volume occurred at both mature inpatient programs without open heart surgery in Palm Beach County, St. Mary's and Boca Raton. The suggestion that 1992 is an aberration in this regard, is rejected. See, Findings of Facts 28 and 30. Impact On Existing Providers The highest reasonable expectation of volumes for St. Mary's cath lab in 1993 is 330 visits. From October 1, 1991 through September 30, 1992, Good Samaritan transferred 13 to 14 inpatients to St. Mary's for cardiac caths. Subsequently, in December 1992, a group of internists sold their practices to Good Samaritan. The patient volume of that group, one internist estimated, will result in the referral of 150 to 200 patients for cardiac caths over the next year or two. Based on their staff affiliations, it is reasonable to expect that a significant number of their referrals will be diverted from St. Mary's. One doctor in a group of invasive cardiologists, which has performed approximately 150 cardiac caths a year at St. Mary's, expects 75 to 90 of the cases would have been done at a Good Samaritan inpatient lab, if that alternative had existed. It is reasonable to expect that an inpatient cardiac cath program at Good Samaritan will result in a loss of up to 80 visits to the St. Mary's cath lab in 1995 and 1996. As a result, the St. Mary's program would be below 300 procedures (visits) a year minimum quality of care standard, with no assurance that Good Samaritan could exceed the standard. Good Samaritan describes the financial impact on St. Mary's of an inpatient cath lab as relatively insignificant, because the more detrimental impact will occur as a result of the already established outpatient lab. Good Samaritan estimates, however, that 70 percent of its cardiac cath patients will be inpatient and 30 percent will be outpatients. St. Mary's financial loss would be $188,000 if Good Samaritan reaches 480 procedures, according to Good Samaritan's expert. Good Samaritan concedes that St. Mary's is at risk of performing less than 300 procedures and, therefore, that the quality of care in the St. Mary's cath lab would decline. However, as Good Samaritan notes the decrease in volumes below 300 may occur whether or not Good Samaritan's proposal is approved. Cardiac cath volumes are declining at mature inpatient programs which do not have open heart surgery services. The establishment of a program at Good Samaritan would accelerate that trend at St. Mary's. See, Finding of Facts 33. When Good Samaritan's cardiac cath volumes reach 240 visits, Palm Beach Gardens expects to lose 44 cardiac cath visits and $134,000 pre-tax revenue in Good Samaritan's second and third year of operation. If, as projected by Good Samaritan, its volumes reached 480 visits, a loss of 88 cardiac caths or approximately $250,000 to $270,000 is projected. Good Samaritan contends that a loss of $250,000 to $270,000 pre-taxes for Palm Beach Gardens is relatively insubstantial. After taxes, the loss is $80,000 when Good Samaritan reaches 240 cases, or $160,000 if Good Samaritan reaches 480 cases. Revenues at Palm Beach Gardens, in 1992, were approximately $8 million pre-taxes, or $5 to $6 million after taxes. Good Samaritan's contention that the loss to Palm Beach Gardens is relatively insubstantial is supported by the evidence in this case. Financial Feasibility Good Samaritan has already constructed an outpatient cardiac cath lab, which is adequately staffed and capable of serving inpatients of the facility. The immediate financial feasibility of the proposal has been established. The long term financial feasibility of the program has been questioned. The pro forma attached to the application showed a loss of $126,008 in year one, a loss of $26,967 in year two and a gain of $113,224 in year three of operations. Good Samaritan was required to include a two year pro forma in its application. In fact, Palm Beach Gardens' expert believes that profitability must be demonstrated in the second year to establish financial feasibility. Good Samaritan's projections are based on the assumption that case volumes will be 240 cases in 1994, 360 in 1995 and 480 in 1996. The assumption that Good Samaritan can reach 360 procedures in year two, while St. Mary's remains over 300 procedures is rejected. In addition, Good Samaritan's pro forma is prepared as Good Samaritan acknowledges, on a fully allocated cost basis which cannot demonstrate financial feasibility. Good Samaritan's exhibit 39 was described as a sensitivity analysis, and is also based on only slight changes in utilization assumptions caused by rounding to whole numbers. Unlike the pro forma submitted with the application, exhibit 39 clearly is an incremental analysis. Good Samaritan failed to provide AHCA adequate evidence of financial feasibility based on the pro forma included in the application. Palm Beach Gardens asserts that consideration of exhibit 39 constitutes an impermissible, untimely amendment to the application which may not be relied upon to establish financial feasibility. Mr. Musgrave, an expert in hospital financial operations, acknowledged that the information in exhibit 39 was available at the time he prepared the application pro forma. Comparing the two, he testified that among the differences are the use of different data bases, a higher Medicare case weight, a lower managed care discount rate, higher gross charges per admission, and lower indigent care percentages. Good Samaritan also failed to account for certain capital costs. Good Samaritan claims that the project has no capital costs. The State Agency Action Report determined that the $5,000 filing fee is a capital cost. At hearing, there was expert testimony that expenses and equipment required to implement video-conferencing and other direct contacts with Duke University will result in additional costs which have not been adequately considered in Good Samaritan's financial analysis. Mr. Musgrave also testified that 70 percent of the cardiac cath volume is expected to be derived from inpatients, with capital cost reimbursements from Medicare and Medicaid. When asked about Good Samaritan's claim that there are no or minimal capital costs associated with the proposal, Robert P. Maquire of AHCA testified as follows: With regard to outpatient services that are approved by non-reviewability criteria, if later a project is established as an inpatient program and does not require any new construction, those costs - - there's no allocation of costs to the inpatient factor. Transcript, Vol. VIII, p. 1041.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that an order be entered denying the application of Good Samaritan Hospital, Inc. for Certificate of Need 7086 to establish an adult inpatient cardiac catheterization program. DONE AND ENTERED this 2nd day of November, 1994, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER 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 2nd day of November, 1994.
