Findings Of Fact The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================
Findings Of Fact Petitioner, Peter P. McKeown, is a graduate of the University of Queensland Medical School in Brisbane, Australia. He holds the degrees of Bachelor of Medicine and Bachelor of Surgery. Doctorates of Medicine, under the British system, are reserved for specialists. Nonetheless, the medical training Petitioner received equates to that leading up to the award of the degree of Doctor of Medicine in the United States, and he is a physician and licensed as such in several states. He has completed residencies in general and thoracic surgery in Australia and the United States and has taken advanced training in cardiovascular and thoracic surgery at Emory University. Immediately before coming to the University of South Florida, (USF), Dr. McKeown was an Assistant Professor of Surgery at the University of Washington. In mid to late 1988, Dr. McKeown responded to an advertisement USF had placed in the Journal of the American Medical Association seeking applicants qualified for appointment at the Associate Professor level "... to join the Department of Surgery at the University of South Florida College of Medicine as the Chief of Cardiothoracic Surgery." He was selected for the position and joined the faculty effective May 1, 1989. All the correspondence leading up to Petitioner's joining the University faculty referred not only to his appointment as Associate Professor but also his assignment as Chief of the Cardiothoracic Surgery Division. Only the actual state employment contract described his employment exclusively as Associate Professor and made no mention of the Chief position. Under these circumstances, Petitioner did not gain any proprietory interest in the position of Chief of the Cardiothoracic Surgery Division. Dr. McKeown held the position of Chief of the Cardiothoracic Surgery Division until April, 1994, when, as a result of a decision made by the Chairman of the school's Department of Surgery, he was replaced as Chief and that position was filled, on a temporary basis, by the Department Chair. Petitioner claims that when he arrived at USF to assume the directorship, an administrative position, he saw an opportunity to develop the position into something significant. He contends he would not have come to USF unless he was to be the Chief of the Division as there was no appeal to him in a position as a general faculty member. He wanted an opportunity to budget, hire people, and develop plans and programs, and in order to advance in academic medicine, one must, at some point, hold an administrative position. Apparently the Department of Surgery had experienced a rapid turnover in faculty. It is not clear whether this caused or was the result of a dispute with administrators and medical staff at Tampa General Hospital, (TGH), where much of the clinical medical school activity is carried on. However, the program was recognized as being weak in cardiothoracic surgery, and this condition offered Petitioner the challenge he wanted. In his five years as Chief, Petitioner increased both the number and quality of personnel and revenues considerably. He developed affiliations with several foreign universities and recruited qualified people, built up the laboratory, secured more grants, developed a program of continuing medical education and raised the examination scores of the school's graduates. He opened new clinical programs and built up both billings and collections to the point where the program revenues were increased at least 2 to 5 times. By 1992- 1993, the Division was making money and generating a surplus and still used clinic funds to support research. During his tenure as Chief of the Division, Petitioner served under two Department of Surgery chairmen. The first was Dr. Connar, the individual who recruited him; and the incumbent is Dr. Carey, the individual who removed him. Petitioner asserts that at no time during his tenure in the position of Chief of the Cardiothoracic Surgery Division was he ever told, by either Department Chairman, that his performance was unsatisfactory. All Division heads within the Department were, from time to time, counseled about personnel costs, and Petitioner admits he had some differences with Dr. Carey about that subject and some other financial aspects of the job, but nothing different than anywhere else in academia. Petitioner was removed by Dr. Carey based in part upon his alleged inability to get along with people. Though he claims this is not true, he admits to three areas of conflict. The first related to his objection to transplants being accomplished by unqualified surgeons which, he alleges, Dr. Carey permitted to further his own ends. The second related to the pediatric heart transplant program for which Petitioner supported one candidate as chair and Dr. Carey supported another. The third related to Petitioner's reluctance to hire a physician whom Dr. Carey wanted to hire but to whom Petitioner purportedly objected. Of the three areas of dispute, only the first two came before his removal, but he contends at no time was he advised his position was a problem for the Department. By the same token, none of Petitioner's annual performance ratings reflected any University dissatisfaction with his performance. At no time was he ever rated unsatisfactory in any performance area; and prior to his removal, he had no indication his position as Chief of the Division was in jeopardy. Dr. Carey indicates he did counsel with Petitioner often regarding his attitude but did not rate him down because he hoped the situation would improve. Dr. McKeown was called to meet with Dr. Carey in his office on April 12, 1994. At that meeting, Dr. Carey was very agitated. He brought up the "Norman" incident and indicated he was going to remove Petitioner as Chief of the Division. Dr. McKeown admits to having made an inappropriate comment regarding Dr. Norman, another physician, to a resident in the operating room while performing an operation. He also admits that it was wrong to do this and apologized to Dr. Norman both orally and in writing shortly thereafter. Dr. Norman accepted his apology and Petitioner asserts that after his removal, Dr. Norman called him and assured him he, Norman, had not prompted the removal action. Dr. Norman did not testify at the hearing. Dr. Carey removed Petitioner from his position as Chief because of the comments he had made regarding Dr. Norman. Almost immediately after the meeting was concluded, Dr. Carey announced in writing his assumption of the Chief's position, in which position he remained until he hired Dr. Robinson as Chief in April, 1995. Petitioner found out that Carey's threat to remove him had been carried out the following day when his nurse told him his removal had been announced at the Moffett Cancer Center. He thereafter heard other reports of his removal from other sources, and based on what had happened, concluded his removal was intended to be and constituted a disciplinary action for his comment regarding Dr. Norman. He was not advised in advance of Carey's intention to impose discipline nor given an opportunity to defend himself before the action was taken. He claims he was not given any reason for his removal before or at the time of his dismissal. It is found, however, that the removal was not disciplinary action but an administrative change in Division leadership. Dr. McKeown at first did nothing about his removal, believing it would blow over. However, after he heard his removal had been publicized, he called several University officials, including a Vice-President, the General Counsel and the Provost, to see how the matter could be handled. He claims he either got no response to his inquiries or was told it was a Medical College problem. He then met with the Dean of the College of Medicine who indicated he could do nothing. After he was removed as Division Chief, Petitioner's salary remained the same as did his supplement from his practice. He claims, however, his removal has had an adverse effect on his reputation in the medical and academic communities. It is his belief that people now feel something is wrong with him. Dr. Carey's blunt announcement of his assumption of the Chief's position, without any reasons being given for that move or credit being given to Petitioner for his past accomplishments has had an impact on his ability to work effectively. After his removal, he received calls from all over the world from people wanting to know what had happened. The removal has, he claims, also made it more difficult for him to get grants and has, thereby, adversely impacted his ability to do productive research. In addition, his removal made it difficult for him to carry out his academic duties. His specialty is still presented in student rotations, only in a different place in the medical curriculum. Dr. McKeown has sought reinstatement to the administrative position of Chief of the Division. He is of the opinion that Dr. Carey's action in removing him from his position as Division Chief was capricious and damaging to the University as well as to his career. Petitioner admits he could have been less confrontational in the performance of his duties as Division Chief, but he knows of no complaints about him from TGH, All Children's Hospital or the VA Hospital. There are, however, letters in the files of the Department Chairman which indicate some dissatisfaction with Petitioner's relationships in some quarters and, as seen below, there were signs of dissatisfaction from both TGH and All Children's Hospitals. Petitioner admits he may have been somewhat overbearing or abrasive, but neither his alleged inability to properly steward finances nor his alleged inability to get along with people were mentioned to him at the time of dismissal or before. After Dr. Carey assumed the Chairmanship of the Department of Surgery in July, 1990, he saw Dr. McKeown frequently on an official basis at first. A Chief, as Petitioner was, has many and varied functions such as administration, teaching, fiscal, research, clinic administration and the like. People skills are important because of the necessary interface with colleagues, faculty, administrators and the public. When Dr. Carey came to USF, Dr. McKeown had not been in place very long, and the Division of Cardiothoracic Surgery was not doing well financially. There were contract negotiations going on with the VA Hospital which were not going well, at least partly because, Dr. Carey asserts, Dr. McKeown had made some major unacceptable demands. As a result, Dr. Carey stepped in, along with Dr. Benke, who was very effective in dealing with the VA, and as a result, an agreement was reached which resulted in somewhere between $275,000 and $300,000 per year coming in which put the Division in the black. Dr. Carey recalls other instances indicating Dr. McKeown's inability to get along with others. One related to the relationship with TGH previously mentioned. TGH had made a decision to use a particular physician as head of its transplant program because, allegedly, Dr. McKeown had so angered private heart patients they would not let him be appointed even though Dr. McKeown was Dr. Carey's choice. As it turned out, Dr. Carey convinced the TGH Director and another physician to agree to a plan whereby Dr. McKeown would be head of the program 50 percent of the time. This would have been good for the University, but Dr. McKeown refused indicating that if he could not be in charge all of the time, he would not be in charge at all. Another incident relates to All Children's Hospital. That institution wanted to initiate a pediatric heart transplant program and a meeting was set up to which Dr. McKeown was invited. Petitioner so infuriated the community surgeons attending that meeting they would not work with him, and without his, Carey's, efforts, Dr. Carey claims the program was doomed to failure. As a result, Carey asked Dr. Nevitsky to help get the program started. This gave the USF an opportunity to participate in the program, but when Nevitsky left, they lost it. Still another example, according to Dr. Carey, is the fact that some surgeons on staff have called to complain about Dr. McKeown's attitude and unwillingness to compromise and negotiate and about his demands for service and staff, all of which creates friction among the hospital staff. A few days before Dr. Carey removed Petitioner as Chief, he spoke with the Dean of the College of Medicine, a Vice-president of the University, and others who would be impacted, about his concern regarding the Cardiothoracic Surgery Division and, in fact, he had had discussions with other officials even before that time. Long before making his decision to remove Petitioner, Carey spoke of his consideration of possibly shifting the emphasis within the Division to non-cardiac thoracic surgery in place of the cardiac program which Dr. Carey felt was not very successful. He believed the program did not do enough procedures to support the medical school affiliation. Dr. Carey chose to dismiss Dr. McKeown as Chief of the Division on April 12, 1994, after learning of McKeown's destructive attack on another surgeon before a junior physician in a public place, an operating room, (the Norman incident). He notes that over the years there was a building concern regarding Dr. McKeown's abilities as an administrator, and this incident with Dr. Norman was the last straw. Dr. Carey had received complaints about Petitioner from other physicians, all of which he discussed with Dr. McKeown. Finally, with the Norman incident, it became abundantly clear that Dr. McKeown's capabilities as a leader had diminished to the point where a change was necessary. Before he dismissed Petitioner, and during the investigation which led up to the dismissal, Dr. Carey admits, he did not give Dr. McKeown any opportunity to give any input to the decision. By the time Carey met with McKeown on April 12, 1994, his mind was made up. The Norman incident was demonstrative of what Carey perceived as McKeown's lack of supervisory ability, and it was that factor which led Carey to the ultimate decision to remove McKeown. He felt it necessary to act then and not leave Dr. McKeown in place during the search for a replacement. Petitioner cites alleged comments made by Carey to others that he would have relieved anyone for doing what Petitioner did in the Norman incident. Dr. Carey cannot recall having made such a statement. He claims he considered disciplinary action against Petitioner for the Norman comments but decided against it. However, it was the last in a series of incidents which caused him to question the propriety of McKeown's placement in the Chief's position, and which ultimately cemented his decision to replace him. Dr. Carey met with Dr. McKeown several times before the dismissal and counseled him about administrative deficiencies in his performance, but he never told Dr. McKeown that unless he improved, he would be dismissed. This is consistent with Petitioner's testimony that he was not warned of his shortcomings or of the administration's dissatisfaction with his performance. Disagreements in conversations between superior and subordinate, meant by the former to be corrective in nature, are not always taken as such by the latter. Dr. Carey did not document any of this in Dr. McKeown's personnel files but put some of the information he received by way of communications from others in the files. These are the letters submitted by the University, pursuant to agreement of the parties, subsequent to the hearing. They contributed to Carey's increasing concern about Dr. McKeown's ability to lead the Division. At no time, however, though he questioned Dr. McKeown's leadership, did Dr. Carey ever question his good faith and sincerity, nor does he do so now. When he finally decided action was necessary, on April 12, 1994, Dr. Carey wrote a memorandum to the Medical College faculty concerning his assumption of the position as Chief of the Cardiothoracic Surgery Division. He also advised Dr. McKeown of his removal. Dr. Carey remained in the Chief's position, holding that title in an administrative capacity and not from a clinical standpoint, for approximately one year, intending to stay in the position only until he could find a fully qualified thoracic surgeon to take the job. After Carey removed Petitioner, he was contacted by the Medical College Dean who asked that he get with McKeown and try to work something out. He thereafter offered Dr. McKeown the position of Chief of the cardiac section of the Division but McKeown declined. Dr. Carey also, on April 26, 1994, wrote to TGH recommending that Dr. McKeown be allowed to have more impact on the hospital's transplant program, pointing out that the change in McKeown's position at the University was occasioned by a need for a change in leadership. According to Dr. Tennyson J. Wright, Associate Provost of the University, disciplinary action against nonunion faculty members is governed by Rule 6C4-10.009, F.A.C., and requires notice of proposed action be given before such disciplinary action is taken. The contract which Dr. McKeown holds and has held since the inception of his tenure at the University, is a standard USF/State University System contract. It reflects Petitioner was hired as an Associate Professor, which is one of the three types of personnel classifications used within the system. These are faculty, administration and support. Petitioner's contract does not refer to his holding the Division Chief position and it is not supposed to. Such a position is an administrative appointment within a Department and a working title used to define the holder's duties, and service in such a position is at the pleasure of the Department Chair. Appointment to or removal from a Chief position is an administrative assignment. The position of Department Chairperson, on the other hand is a separate position and subclassification within the University classification system and is different.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Petitioner, Peter P. McKeown's, grievance against the University of South Florida School of Medicine arising from his removal as Chief, Cardiothoracic Surgery Division in the Department of Surgery be denied. DONE AND ENTERED this 19th day of January, 1996, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 19th day of January, 1996. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 95-1832 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. - 7. Accepted and incorporated herein. Though the documents in question refer to appointment, in actuality the personnel action was an appointment to the faculty with an administrative assignment to the position of Director of the Division. & 10. Accepted. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted and incorporated herein. - 19. Accepted and incorporate herein. Accepted and incorporated herein. Accepted. Rejected as inconsistent with the better evidence of record. Accepted. Accepted and incorporated herein. Rejected as inconsistent with the better evidence of record. & 27. Accepted. & 29. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. 32. - 34. First sentence accepted. Second sentence rejected as inconsistent with the better evidence of record. 35. - 37. Accepted. 38. Rejected as argument. 39. Accepted. FOR THE RESPONDENT: - 9. Accepted and incorporated herein. Accepted. - 14. Accepted and incorporated herein. 15. & 16. Accepted and incorporated herein. COPIES FURNISHED: Benjamin H. Hill, III, Esquire William C. Guerrant, Jr., Esquire Danelle Dykes, Esquire Hill, Ward & Henderson, P.A. Post Office Box 2231 Tampa, Florida 33601 Thomas M. Gonzalez, Esquire Thompson, Sizemore & Gonzalez 109 North Brush Street, Suite 200 Post Office Box 639 Tampa, Florida 33601 Olga J. Joanow, Esquire University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620 Noreen Segrest, Esquire General Counsel University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620-6250
The Issue Whether Petitioner is entitled to a Certificate of Need ("CON") authorizing establishment of an (ophthalmological) ambulatory surgical center in Palm Beach County, Florida. Subordinate issues are: Whether the proposed facility satisfies the CON criteria of Sections 381.494-499, Florida Statutes, as implemented by Respondent, Department of Health and Rehabilitative Services ("HRS) rule and non-rule policy; Whether the proposed facility will result in unnecessary duplication of services, underutilization of existing services and increased health care costs to the community; Whether adequate resources are available for the construction and operation of the proposed facility; and Whether the proposed facility is financially feasible.
Findings Of Fact (Numbering corresponds to numbering used in proposed findings.) Preliminary findings: 1-4. Approved. On issue of compliance with applicable criteria: 1-7. Approved. 8. Approved, with caveat that this is subject to supplying an adequate record basis for the policy at hearing. 9-13 Approved. Approved but no presumption of correctness attaches to HRS earlier or more recent evaluation of the application. See, Boca Raton, supra. Approved. Approved but modified to more accurately reflect that HRS takes HMO's into account, but this factor was not used or relied on (in connection with the non-rule policy or standing alone) as the basis for granting Petitioner's application. Approved. 18-32. Approved, in the sense that an HRS expert witness at hearing offered conclusions as to compliance with each statutory criteria; rejected, in that his conclusions (except for those concerning quality of care, financial feasibility, the inapplicability of some criteria, and the cost advantages of modifying an existing facility instead of constructing a new one) are rejected as unsubstantiated by the facts. On the Issue of Need: 1-8. Approved. Approved. Modified to reflect that this is one estimate among several offered by experts. Rejected as unsupported by the credible evidence of record. Approved. Approved. First sentence, approved, in that this is the stated "attempt" of HRS' challenged non-rule policy. Second sentence, rejected as unsupported by the credible evidence; the profitable performance of outpatient surgery at a physician's office does logically compel a conclusion that his office should be licensed as an ambulatory surgical facility. On the issue of adequate resources: 1-8. Approved. On the issue of financial feasibility: 1-19 Approved. 20. Rejected as argumentative. RULINGS ON INTERVENOR'S PROPOSED FINDINGS 1-4. Approved. 5. Approved except for reference to equipment costs, of which there will be none. 9-16 Approved. 17. Such broad-brush incorporation of all facts asserted in argument is not susceptible to explicit rulings. RULINGS ON POST-HEARING MOTIONS. Intervenor's "Motion to Stay Issuance of Recommended Order" is denied. Intervenor's "Request for Hearing Officer to Take Official Recognition" of the Final Order of Hearing Officer Robert T. Benton II, in consolidated DOAH Case Nos. 85-2962R, 85-2963R and 85-3193R (attached to a "Notice of Supplemental Authority" dated November 1, 1985) is granted. The order is made a part of the record of this proceeding. A final order entered by another hearing officer of the Division of Administrative Hearings the authenticity of which is not in question, is an appropriate document to be accorded official recognition. See, Health Quest Realty XII v. HRS, 10 FLW 1729 (Fla. 1st DCA July 16, 1985, pet. for reh. pending). COPIES FURNISHED: Eric B. Tilton, Esquire 104 S. Monroe St. Tallahassee, Florida 32301 Theodore E. Mack, Esquire 1323 Winewood Blvd. Tallahassee Florida 32301 William B. Wiley, Esquire Post Office Box 2174 Tallahassee, Florida 32316
Recommendation Based on the foegoing it is RECOMMENDED: That Petitioner's application for a CON authorizing establishment of an ambulatory surgical facility at his offices in Palm Beach County, Florida, be DENIED. DONE and ORDERED this 15th day of January, 1986, in Tallahassee Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee Florida 32301 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of January, 1986.
The Issue Should Respondent Patricia Dee G. Stehpenson's license to practice medicine in the State of Florida be revoked, suspended or otherwise disciplined based on the allegations contained in the Administrative Complaint filed herein?
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all times material to this proceeding, the Respondent was a licensed physician in the State of Florida, having been issued license number ME 0051453. The patient, a 73 year old female, presented to Respondent on July 11, 1991, with complaints of flashes of light over the past ten years which had increased over the past two years. The patient also complained of seeing halos around street lights at night. During this visit, Respondent diagnosed the patient as having 20/30 corrected vision in her right eye and 20/40 plus 2 corrected vision in her left eye, and that the patient had cataracts. However, Respondent did not recommend cataract surgery at this time. In January, 1992, the patient took the State of Florida driver's license test, including the eye test, and received her driver's license. However, the examiner notice that the patient was having trouble with the eye test and, although the examiner gave the patient her driver's license, the examiner suggested that the patient see an opthalmologist. At the time the patient received her driver's license in January, 1992, the patient was enjoying golf, bowling and driving. Although the patient did not immediately follow the driver's license examiner's advice concerning her eyes, the patient did visit with Respondent on May 8, 1992. At this visit, the patient advised the Respondent that the flashes and floaters had improved but that her vision was interfering with her golfing and driving. Again, Respondent did not recommend removal of the cataract. The patient's vision continued to interfere with her golfing and driving, notwithstanding the patient's testimony to the contrary which I do not find to be credible. The patient's next visit with Respondent was on October 16, 1992. At this visit, the patient advised Respondent that her vision had "lessened a lot" in the left eye. Visual acuity testing indicated corrected vision of 20/30 in the right eye and 20/40 plus 2 in the left eye. However, while the level of vision at which the patient was able to perceive letters (20/40 plus 2) did not change, the refraction (stronger glasses) required to achieve that level indicated more myopia, indicating that the cataract had progressed which supports the patient's complaint that her vision had "lessened a lot". Also at the October 16, 1992, visit, Respondent tested the patient's vision using brightness acuity testing (glare test) and measured the patient's vision as 20/70, with glare in the left eye. The glare test is a method whereby the doctor shines a light in the person's eye to determine the effect of glare on the person's vision. Although some ophthalmologists consider the glare test of no value, other ophthalmologists consider the glare test as another tool to assist the surgeon in making a decision concerning the necessity for cataract surgery. During the October 16, 1992, office visit, Respondent discussed with the patient: (a) the effect the cataract was having on the patient's activities (life-style); (b) the patient's complaint that her vision had lessened; (c) the results of the glare test showing the patient's vision as 20/70 with glare and; (d) other visual acuity testing; and (e)advised the patient that cataract surgery was indicated. Also, Respondent explained the cataract surgery procedures and discussed with the patient the risks and the benefits of the surgery. The patient had no reservations or objections to the surgery and consented to the surgery in hopes of improving her eyesight as well as her life- style. For a person with cataracts, a corrected vision of 20/40 or worse is the vision level where some cataract surgeons will recommend cataract surgery, while other cataract surgeons consider a corrected vision of 20/50 or worse, with or without glare, as the vision level where cataract surgery should be recommended. However, because the vision as determined by visual acuity testing (the ability of the person to perceive letters) does not always accurately reflect the person's quality of vision (the quality of perception on a day to day basis), neither vision level referred to above when considered alone can be used as a hard and fast rule to form a basis for cataract surgery. Since the quality of vision can only be described by the person with the cataract(s), the cataract surgeon must also determine, after consultation with the person, that the cataract(s) are interfering with the person's life-style. Therefore, a person with corrected vision of somewhat better than 20/40 or 20/70 with or without glare, may be a candidate for cataract surgery, provided the cataract is causing a reduction in the person's quality of vision beyond what is indicated by visual acuity testing and thereby interfering with the person's life-style. Furthermore, there are no written standards or guidelines which set a particular vision level for the cataract surgeon to follow when making a decision to recommend cataract surgery. The surgeon must take into consideration all factors and make a decision based on the surgeon's judgment as to what is best for that person. The patient's vision level and the interference the patient was experiencing with her life-style because of the cataracts in her left eye justified Respondent's decision to recommend and perform the cataract surgery on the patient, notwithstanding any of the testimony of Dr. Leslie Monroe to the contrary. On November 3, 1992, Respondent performed phacoemulsification (removal of cataract) with posterior chamber intracular lens implant (implantation of lens) on the patient's left eye. While the patient was in the holding area being prepared for surgery there were complications with the anesthesia. The anesthesiologist, Robert Dienes, M. D., first gave the patient a retrobulbar block which was repeated apparently due to Dr. Dienes' conclusion that the first retrobulbar block was ineffective. Apparently, Dr. Dienes also concluded that the second retrobulbar block was ineffective and gave the patient a superior lid peribulbar block. After giving the peribulbar block, Dr. Dienes noticed a dissecting subconjunctival hemorrhage and notified Respondent. Upon examining the patient's eye, Respondent found the globe (whole eye) to be soft with no active bleeding, indicating the eye was not full of blood and that there was no retina tear or rupture of the globe. Respondent also noticed that "the conjunctiva was real chemotic or it had blood behind it". Respondent also measured the patient's eye pressure with a Schiotz tonameter because there was no slit-lamp in the holding area. The patient's eye pressure was 5, with a 5.5 gram weight, which was normal. The patient's medical records do not reflect an indirect ophthalmoscopy being performed by Respondent on the patient's left eye between Respondent being advised of the dissecting subjunctival hemorrhage by Dr. Diemes and the Respondent performing surgery on the patient's left eye to remove the cataract and implant the lens. Furthermore, Respondent has no independent recollection of performing an indirect ophthalmoscopy during the above period of time before surgery. Respondent's normal practice under conditions and circumstances similar to those in this case has been to perform an indirect ophthalmoscopy during the above period of time before surgery. Therefore, it is assumed that Respondent performed an indirect ophthalmoscopy on the patient after being advised of the subconjunctival hemorrhage but before surgery, notwithstanding the fact that patient's medical records do not reflect such procedure being performed or the fact that Respondent has no independent recollection of performing such procedure during the above period of time. However, assuming arguendo that Respondent did not perform the indirect ophthalmoscopy before surgery, the Agency has failed to establish facts to show that under the conditions and circumstances of this case that such failure amounted to the failure of Respondent to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. After considering the conditions and circumstances surrounding the complication that arose while the patient was being anesthetized, Respondent made a decision that it was in the best interest of the patient to go forward with the removal of the cataract and implantation of the lens. The operation was completed without any further incident and there was a successful removal of the cataract and lens transplant. Respondent's decision to go forward with the surgery had no adverse effect on the subsequent treatment of the complication that arose while the patient was being anesthetized. In fact, the result of the treatment subsequent to the cataract surgery would have been the same even if Respondent had not gone forward with the surgery. Respondent, using a ophthalmoscope, was able to see the inside of the eye more clearly and assess the complication that arose while the patient was being anesthetized. While performing this indirect ophthalmoscopy, Respondent noted undulation of the vitreous with pigmented blood cells present and that the anesthesia needle had penetrated the globe. The patient was seen the next morning, November 3, 1992, by Respondent. After assessing the condition of the patient's left eye, Respondent referred the patient to Keye Wong, M. D., a retina specialist. Upon examining the patient's left eye on November 4, 1992, Dr. Wong noted vitreous hemorrhaging and retinal detachment. Dr. Wong performed an operation on the patient's left eye in an attempt to correct the damage and attach the retina. The patient's vision is not as good as it was before the operation, and still effects the patient's life-style. The patient has difficulty tolerating sunlight, which may or may not be a result of the complication experienced while the patient was being anesthetize. Respondent's action of going forward with the surgery after becoming aware of the complication that arose while the patient was being anesthetized did not cause, complicate, aggravate or result in any of the problems the patient has suffered postoperatively. Respondent did not fail to recognize, identify or treat properly the complications that arose before, during or after the surgery. The Agency has failed to establish facts to show that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances at anytime while Respondent was treating the patient, including both preoperative and postoperative treatment.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Petitioner Agency for Health Care Administration enter a final order dismissing the Administrative Complaint filed herein against Respondent Patricia Dee G. Stephenson, M. D. DONE and ENTERED this 23rd day of January, 1996, at Tallahassee, Florida. WILLIAM R. CAVE, 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 23rd day of January, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1560 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the Petitioner and the Department in this case. Agency's Proposed Findings of Fact. Proposed findings of fact 1-2 are adopted in substance as modified in Findings of Fact 1 and 2. The first sentence of proposed finding of fact 3 is adopted in Finding of Fact 3. The second and third sentence are not supported by evidence in the record. Proposed finding of fact 4 is adopted in substance as modified in Finding of Fact 5, otherwise not supported by evidence in the record. Proposed finding of fact 5 is adopted in substance as modified in Finding of Fact 7, otherwise not supported by evidence in the record. Proposed finding of fact 6 is adopted in substance as modified in Findings of Fact 12, 13, and 14, otherwise not supported by evidence in the record. Proposed findings of fact 7 and 8 are adopted in substance as modified in Findings of Fact 21 and 22, otherwise not supported by evidence in the record. Proposed finding of fact 9 is a restatement of Dr. Monroe's testimony and is not a finding of fact. However, see Findings of Fact 16 and 17. 8, Proposed findings of fact 10, 16, 17 and 19 are adopted in substance as modified in Findings of Fact 15, 16, 10, 8 and 9. Proposed finding of fact 11 is adopted in substance as modified in Finding of Fact 16, otherwise not supported by evidence in the record. Although proposed findings of fact 12, 13 and 15 are findings of fact, they are neither material nor relevant to this proceeding. See Finding of Fact 9. Proposed finding of fact 14 is a restatement of Dr. Grabow's testimony and is not stated as a finding of fact, but see Finding of Fact 10. Dr. Grabow's testimony was 20/50 vision with or without glare which is different than just 20/50 vision. 11. Proposed findings of Fact 18 and 20 are not supported by evidence in the record. Respondent's Proposed Findings of Fact. 1. Proposed findings of fact 1 through 27 are adopted in substance as modified in Findings of Fact 1 through 25. COPIES FURNISHED: Marm Harris, M. D., Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, Esquire Agency for Health Care Administration Fort Knox Building Number Three 2727 Mahan Drive Tallahassee, Florida 32308 Steve Rothenburg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 William E. Partridge, Esquire Lutz, Webb, Partridge, BoBo, and Baitty One Sarasota Tower 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236
Findings Of Fact I. Proposed findings of Medivision and DHRS Included in HO # 1. Accepted insofar as included in HO # 13. Included in HO # 2. Included in HO #6. Included in HO #5. Accepted insofar as included in HO #11. Included in HO 8 and 9. Included in HO 3 and 10 and 12, 13, and 14. Rejected insofar as inconsistent with HO #16. Accepted insofar as included in HO #2. Accepted. Not deemed relevant to results reached. Accepted insofar as included in HO #18. Included in HO #2. Accepted. Not deemed relevant to results reached.- Included in HO #2. Rejected as inconsistent with HO #14 and 15. Rejected as inconsistent with HO #15,16, and 17. Rejected as inconsistent with HO #15,16, and 17. Accepted. Not relevant to results reached. Accepted only insofar as included in HO #19. Included in HO #13, 14. Included in HO #18. Accepted. Not relevant to results reached. Rejected insofar as inconsistent with HO #l3. Included in HO #21. Included in HO #15. Included in HO #15, 16, 19, and 20. PROPOSED FINDINGS WFRMC Included in preliminary portion of RO. Accepted insofar as included in HO 42. Rejected as irrelevant. Rejected as irrelevant. Rejected as irrelevant. Included in preliminary portion of RO. Included in HO #6. Included in HO #6. Accepted insofar as not in conflict with HO #8. Rejected as irrelevant. Rejected as stating a negative. Accepted insofar as in agreement with HO #8. Accepted. Included in HO #20. Included in HO #21. Included in HO $17. Accepted. Included in HO #8. Accepted. Accepted insofar as included in HO #13. Included in Ho #21. Included in HO #16. Included in HO #16. Included in HO #16. APPENDIX JOINT PROPOSED FINDINGS OF BAPTIST HOSPITAL AND SACRED HEART HOSPITAL Accepted. Relevant portions are included in HO #1. Included in HO #4. Included in HO #3. Included in HO #3. Included in HO #3. Included in HO #6. Included in HO #8. Included in HO #7. Included in HO #8. Included in HO #10. Included in HO #10. Accepted insofar as included in HO #15. Accepted insofar as included in HO #12 and 16. Accepted insofar as included in HO #16. Rejected as conclusion of law Included in HO #18. Included in HO #18. Included in HO # 2. Rejected as not relevant. Included in HO #2. Included in HO #18. Accepted insofar as included in HO #8,9, and 15. Accepted insofar as included in HO #17. Included in HO #18. Accepted insofar as included in HO #16. Accepted. Not included because irrelevant and immaterial. Figures rejected as speculative. Accepted insofar as included in HO #17. Accepted insofar as included in HO #17. Rejected as inconsistent with HO #18. Rejected as conclusion of law. Rejected. Non-rule policy not applicable to specialty ambulatory surgery centers. ================================================================= AGENCY FINAL ORDER ================================================================= STATE OF FLORIDA DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES MEDIVISION OF ESCAMBIA COUNTY, INC., Petitioner, vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, CASE NO. 85-2443 Respondent, and WEST FLORIDA REGIONAL MEDICAL CENTER, SACRED HEART HOSPITAL OF PENSACOLA and BAPTIST HOSPITAL, INC. /
The Issue Whether Respondent, Rick J. Billings, O.D., committed the acts alleged in the Administrative Complaint and, if so, what disciplinary action shall be taken against his license to practice optometry.
Findings Of Fact Petitioner, the Department of Health (Petitioner), is the state agency charged with enforcing the statutes and regulations governing the practice of optometry in the State of Florida. However, at the time the complaints in this cause were filed, this responsibility was assigned to the Agency for Health Care Administration. Respondent, Rick J. Billings, O.D., is, and has been at all times relevant to this proceeding, a licensed optometrist in the State of Florida, having been issued License No. OP 0001816 in 1983. Respondent is a Board-certified optometrist and has practiced in Sarasota, Florida, for 13 years. Patient D.R. first presented to Respondent on August 18, 1992. At the time of the initial visit, Patient D.R., a ninety- year old female, was accompanied by her niece, Phyllis Glass. During that initial visit Respondent performed a pre- operative examination, including a vision test, on Patient D.R. Based on his examination, Respondent diagnosed a cataract in Patient D.R.’s left eye and recommended surgical removal of the cataract by Harry B. Grabow, M.D. Notwithstanding this recommendation, Patient D.R. was free to return to her former ophthalmologist had she chosen to do so. Dr. Grabow is an ophthalmic surgeon, Board-certified in ophthalmology in the State of Florida and by the American Board of Eye Surgery. Dr. Grabow has been in private practice in Sarasota, Florida, for 20 years and his medical practice is known as the Sarasota Cataract Institute. Patient D.R. was first seen by Dr. Grabow on September 2, 1992, and again for a pre-operative visit on September 18, 1992. Dr. Grabow performed surgery for the cataract of Patient D.R.’s left eye on September 22, 1992. During his treatment of Patient D.R., Dr. Grabow provided her with written instructions regarding pre-operative and post-operative care and activity, and with medications or prescriptions and written instructions for their use. These printed instructions had been previously discussed with Respondent. Dr. Grabow saw Patient D.R. post-operatively on the first post-operative day, September 23, 1992, and then discharged her to return to the care of Respondent. Thereafter, Respondent assumed responsibility for Patient D.R.'s care. On October 5, 1992, Patient D.R. presented to Respondent for a post-operative visit. At that time, Respondent conducted a problem-specific post-operative examination of Patient D.R. The examination included tests for visual acuities, far and near, corrected and uncorrected, to assess the patient's need for glasses; keratometry; refraction assessment; external examination; slit-lamp pupillary examination; test of macular regions; and bio-microscopy. Respondent was unable to perform a tonometry because Patient D.R. refused. The results of the October 5, 1992, post-operative examination of Patient D.R. were recorded on a form provided by Dr. Grabow; supplied all the information about Patient D.R. that Dr. Grabow needed; and was completed by Respondent in a format that was useful to Dr. Grabow. During the October 5, 1992, office visit, Respondent scheduled Patient D.R. for a re-check in four weeks. However, the patient cancelled her appointment. Thereafter, someone from Respondent’s office called Patient D.R. to make an additional follow-up appointment, but the patient refused, believing that a follow-up visit was unnecessary. Respondent kept the required written optometric records regarding Patient D.R. and otherwise met the applicable standard of care. The written optometric records made and maintained by Respondent were such that a similarly trained optometrist could have treated Patient D.R. after review of her record. The tests performed by Respondent on Patient D.R. during her October 5, 1992, visit were appropriate in a post- operative co-management situation. Likewise, Respondent properly recorded the examinations and the results thereof. During Patient D.R.’s post-operative visit, Respondent did not list medications or re-instruct Patient D.R. regarding medication use. Because Respondent made no changes in the post- operative medication or instructions given by Dr. Grabow, it was unnecessary for Respondent to make notations concerning them. Respondent would have made such notations only if he were changing the previously issued instructions or writing a new prescription. Respondent did not record any information relative to patient education because verbal and written instructions concerning eye care had been provided to Patient D.R. by Dr. Grabow. Furthermore, it was unnecessary for Respondent to repeat or elaborate on those instructions, absent a change or an indication that the patient did not understand the instructions. In this case, there was neither a change in Dr. Grabow’s instructions nor any indication that Patient D.R, did not understand those instructions. On or about October 8, 1992, Dr. Grabow received from Respondent the post-operative co-management information regarding Patient D.R. The information on Patient D.R. that Respondent provided was what Dr. Grabow expected and needed. Similarly, Dr. Grabow determined that the tests performed by Respondent on Patient D.R. during her post-operative visit were adequate for his purposes and met the standard of care for optometrists as well as opthalmologists. On November 26, 1991, prior to seeing Patient D.R., Respondent entered into a Supervised Co-Management Agreement (Agreement) with Dr. Grabow and Sarasota Cataract Institute. Prior to entering into the Agreement, Dr. Grabow and the Sarasota Cataract Institute determined that Respondent was capable of competent post-operative co-management of cataract patients. Moreover, it was determined that Respondent’s post- operative care record met the standard of care for an optometrist in that community. Pursuant to the Agreement, Respondent was permitted to participate in the post-operative care of cataract patients. However, the ultimate responsibility for the care of the co-managed patient remained Dr. Grabow's, as the operating and supervising surgeon. It is Dr. Grabow's custom and standard practice to see his post-operative cataract patient only once. Because patient needs may vary, Dr. Grabow’s practice is to leave the frequency and duration of post-operative examinations to the discretion of the co-managing optometrist who assumes responsibility for the patient. Since entering into the Agreement with Respondent, Dr. Grabow has been satisfied with the care that Respondent rendered to patients which they co-manage, including Patient D.R. In all cases, Dr. Grabow has always provided whatever supervision was necessary, although no such supervision was required during the course of Patient D.R.'s post-operative care. There is no defined standard of care in the statutes or the Board's rules that apply to co-management of post- operative cataract patients. The standards are left to the discretion of the co-managing physicians. Here, the protocol crafted by Dr. Grabow and Respondent became the standard of care, and the post-operative care of Patient D.R. met the applicable standard of care as well as the expectations of Dr. Grabow. The eye examinations required of an optometrist in a post-operative co-management situation are left up to the professional judgment of the doctor or doctors involved, and depending on the type of cataract surgery, the techniques used by the surgeon and the agreement between the co-managing physicians. Respondent performed an examination consistent with that judgment. At all times material hereto, there were no published requirements that specified or enumerated the examinations that should be performed on post-surgery cataract patients. However, with regard to the examinations performed on Patient D.R. during her post-operative care visit, Respondent provided care within the applicable community standard. Respondent's notations of the results of the examinations are consistent with the standard of care. There are no statutes, rules, or guidelines requiring an optometrist to provide patients with instructions regarding their medication or to record a rescheduled visit in the patient's medical record. In this case, based on the Agreement and his previous discussions with Dr. Grabow, Respondent knew what medications and instructions Patient D.R. had been given by Dr. Grabow. In this regard, Respondent met the standard of care. At all times relevant to this proceeding, Medicare permitted a global fee for cataract surgery, which was allowed to be divided in co-management care between an ophthalmologist and optometrist. Under the Medicare-prescribed fee schedule, optometrists who provided post-operative care were able to collect 20% of the global fee; and the operating and supervising physician could receive 80% of the global fee. The division of the global fee between Dr. Grabow and Respondent in Patient D.R.'s case was in compliance with Medicare regulations. Pursuant to 1992 Medicare rules related to billing, the doctor who assumed care in the post-operative period and received the permitted 20% of the global fee was responsible for the care of the cataract patient for up to 90 days after the patient’s first post-operative visit to that physician. After he had seen the patient for one post-operative visit, the doctor was allowed to bill for this twenty percent. No specific number of visits was required in order to bill for 20% of the global fee. However, Medicare did require that the co-managing optometrist assume responsibility for the post-operative care of the patient for the ninety-day period. In 1992, Respondent charged $220.00 for post- operative care for cataract patients. These charges included seeing the patient a minimum of one time after the surgery and being available for a ninety-day period thereafter. Consistent with this fee schedule, Patient D.R. as Medicare patient, was charged and paid a co-payment or estimated deductible of $44.00. Respondent's billing service then, billed the difference, $176.00 to Medicare. This post-cataract surgery care bill submitted to Medicare by Respondent was proper as to the amount claimed for the services provided. With respect to the type of claim that was being filed, however, Respondent's billing service mistakenly filed the claim for Patient D.R.’s post-operative case as an unassigned claim. As a result of the claim being incorrectly designated as an unassigned claim, Medicaid sent 80% of the Medicare approved amount for the post-operative services, $174.86, to Patient D.R. In late January 1993, Patient D.R.’s niece received a call from a member of Respondent’s office staff concerning the $174.86 check. During the conversation, Ms. Glass was told that the charge for post-operative services was $220.00 and that the $174.86 check had been sent to Patient D.R. in error. Subsequently, Ms. Glass telephoned Respondent to discuss the matter. Respondent explained to Ms. Glass that the check $174.86 represented his portion of the total charge for post- operative cataract services. Respondent further explained that this amount included his being available to Patient D.R. for ninety days from October 5, 1992, the date of her post-operative visit to Respondent's office. Respondent's representations and those of his staff were substantiated in the Explanation of Medicare Benefits Statement (Explanation) sent to Patient D.R. According to the Explanation, which was dated November 9, 1992, Respondent’s charge for “care after [cataract] operation" was $220, but the Medicare approved amount for these services was $218.57. After deducting the 20% co-payment amount paid by Patient D.R. to Respondent, the Medicare approved payment for post-operative care was determined to be $176.86. The Explanation noted that because the provider did not accept assignment, Patient D.R. would receive this payment. After receiving the Explanation and communicating with Respondent's office and billing service, Patient D.R. and her family incorrectly assumed that Respondent’s bill for Patient D.R.'s post-operative care was fraudulent. Ms. Glass did not believe that Respondent performed post-operative services for her aunt, and apparently misunderstood or was unaware of the co- management agreement between Dr. Grabow and Respondent. In fact, Ms. Glass and/or her husband were so concerned about Respondent's bill that they wrote letters of complaint to various governmental agencies “alerting them to the fact that we [feel] that there was a miscarriage of justice.” Respondent’s billing records related to Patient D.R.’s post-operative care were reviewed by experts in the area of Medicare and the Medicare Fraud Branch Operations. These reviews failed to disclose any indication that Respondent was guilty of fraud, deceit, negligence or incompetence, or misconduct in the practice of optometry. Similarly, there was no finding that Respondent improperly billed Medicare for services provided to Patient D.R. The Medicare check in the amount of $176.86 for post- operative services Respondent provided to Patient D.R. was never forwarded to Respondent nor did he ever receive payment for these services. In 1992, a co-management situation such as occurred in this case was not deemed to be an improper fee division or receiving a fee for a referral. The arrangement was legal, and pursuant thereto, it was appropriate for the optometrist and the ophthalmologist to both receive payment from Medicare for the services they performed. There was nothing found in review of Patient D.R.'s record to indicate an unlawful kickback in cash or in kind nor a violation of Section 455.657, Florida Statutes. Except for the complaints arising out of the Respondent's treatment of Patient D.R., Respondent has not been the subject of any other disciplinary action by the Board.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a Final Order be entered dismissing the Amended Administrative Complaint against the Respondent, Rick J. Billings, O.D. DONE AND ENTERED this 24th day of March, 1998, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 Filed with the Clerk of the Division of Administrative Hearings this 24th day of March, 1998. COPIES FURNISHED: William C. Childers, Esquire Thomas Wright, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 A. S. Weekley, Jr., M.D., Esquire Holland & Knight LLP 510 Vonderburg Drive Suite 3005 Brandon, Florida 33511 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700 Pete Peterson, Esquire Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700
Findings Of Fact HRS stipulated that the challenging parties, petitioners and intervenor, are substantially affected by, and so have standing to challenge, the memoranda in question. According to the pleadings, the challengers are existing providers of surgical services faced with the prospect of increased competition from competitors likely to receive certificates of need for ambulatory surgical centers under the HRS policy articulated in the challenged memoranda. On June 6, 1985, Robert Maryanski, administrator of HRS' Office of Community Medical Facilities, "issued to staff regarding the review of ambulatory surgical [c]ertificate of [n]eed applications," (T. 71) including applications for certificates of need for limited or specialty ambulatory surgical centers, Deposition of Marta Hardy, p. 23, the following: PDCF POLICY MEMORANDUM #7 JUNE 6, 1985 SUBJECT: Policy on CON review of ambulatory surgical center proposals TO: PDCF (Liz Dudek) PDCF (Paul Reilly) PDCF (Wayne McDaniel) PDCF (Joe Mitchell) The following policies will be employed by this office in the review of ambulatory surgical center CON applications: Based upon a review of available literature and outpatient surgical information obtained from the American Hospital Association Survey, a 30 percent factor will be used as the optimum number of surgeries to be performed on an outpatient basis. In all instances, the potential for outpatient surgeries will be determined at a county level. "Specialty" ambulatory surgical center (e.g., opthalmic) will not be given special consideration. The break even level of operations approach is considered adequate to assess the potential for such facilities. In those instances when the outpatient surgical potential in a county is calculated to be slightly below the applicant's projected break even level of operation and there is no existing and/or approved ambulatory surgical center in the county-consideration will be given to approving the application, assuring all other appropriate criteria are satisfied, to foster competition for outpatient surgery as an alternative to more costly inpatient surgery. Proposals which include a captive population (e.g., health maintenance organization) will be given additional consideration as required by appropriate statutory criteria (e.g., Chapter 381.494(6)(c), Florida Statutes.) If "pre-existing clinics, which have been performing surgical procedures similar to those approval of the project, after assuring that all other appropriate criteria are satisfied. An architectural review will be conducted to verify that the existing facility meets, or will be capable of meeting, licensure requirements. In those instances, in which a hospital makes application for outpatient surgical capabilities or an increase in its existing outpatient surgery capability via the establishment or expansion of operating rooms dedicated to outpatient surgery, the hospital's current level of outpatient surgical procedures will be subtracted from the total hospitals' outpatient surgical procedures. The hospitals' outpatient surgical rate (minus the applicant hospital) will be computed separately from the applicant's outpatient surgical rate. The county's projected population will be used to project hospitals' (minus the applicant hospital) outpatient volume, as well as existing ambulatory surgical facilities' volume. These figures will be subtracted from the total outpatient surgical "pool" projection. The 2nd year break even point number of procedures for approved ambulatory surgical facilities (which either are not in operation or have not operated a full year), is next subtracted from the total "pool." At this point, the projected number of outpatient procedures which would be performed at the applicant hospital, is compared to the remainder from the previous calculations. Should the projected outpatient level equal or exceed the calculated break even level of operation, consideration will be given to approving the application, assuring all other appropriate criteria are satisfied. In the case of hospital ambulatory Surgical projects which do not involve additional operating rooms dedicated to outpatient surgery, the above ambulatory surgery methodology will not be used. Licensed and existing ambulatory surgical centers which have been operational one year or more, will be surveyed to determine the number of procedures performed over one year. These procedures will be applied to the projected population and deducted from the total outpatient potential as described above. In the case of those approved but unlicensed ambulatory surgery methodology will not be used. Licensed and existing ambulatory surgical centers which have been operational one year or more, will be surveyed to determine the number of procedures performed over one year. These procedures will be applied to the projected population and deducted from the total outpatient potential as described above. In the case of those approved but unlicensed ambulatory surgical centers, the previously calculated break even level of operation will be deducted from the total outpatient potential. In all instances, the projected year of operation will be based on the time required for construction, if appropriate, as reflected in the application plus two years from the date of this office's review. "Procedures" include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all other invasive procedures regularly construed of as surgeries. If you have any questions regarding this policy, please contact me upon receipt. This policy is effective on June 15, 1985. Petitioner's Exhibit A The June memorandum stated policy substantially similar to a memorandum authored by Mr. Maryanski's predecessor on February 21, 1985, which contained at least some of the elements of the policy that HRS applied earlier than October 9, 1983, Deposition of Nelson, p. 5, and even as early as December of 1982, Deposition of Porter, p. 11, and which reads: TO: PDCF STAFF SUBJECT: UPDATED POLICY ON CON REVIEW OF AMBULATORY SURGERY PROPOSALS At a meeting with Doug Mannheimer, members of PDCFR, and myself on February 14, the following guidelines for reviewing CON proposals for ambulatory surgery were agreed upon: Effective immediately, we will use 30 percent as the optimum number of surgeries to be performed on an outpatient basis as opposed to 29 percent. health maintenance organizations. The issue of how to deal with "pre-existing" unlicensed ambulatory surgery providers was also discussed. It was decided that if an applicant can demonstrate that it has been providing ambulatory surgical services historically in a facility which meets, or for a minor capital expenditure could meet, licensing requirements and that the provision of such services has been done profitably, this type of applicant should receive special consideration in CON reviews. However, in such cases, it will be necessary for the CON architect to verify that the existing facility meets, or almost meets, licensure requirements, and for the CON accountant to verify that the operation has historically been profitable. Data base issues were discussed. PDCFR was informed of the decision to remove the ambulatory surgery data collection burden from Nell Mitchem. The possibility of having PDCH and/or the local health councils collect such information on a semi-annual basis was discussed and will be explored further by Tom Porter. The method of counting procedures of existing ambulatory surgery centers was considered. The pros and cons of utilizing the center's break even point as described in its CON application versus its actual use was debated. It was decided that existing ambulatory surgery centers which have been in business one year or more will be surveyed to determine their actual use. In the case of those existing centers in business less than one year, the break even point will be used. The issue of counting dedicated hospital-based ambulatory surgery facilities was discussed. It was decided that in instances where a hospital applies for ambulatory surgical capabilities or an increase in that capability via the establishment or expansion of operating rooms solely dedicated to outpatient surgery, the hospital's current provision of outpatient surgery will be subtracted from the total of outpatient surgeries performed and then converted to an institution-specific rate and applied to projected population to determine the need. In the case of hospital ambulatory surgery projects not involving additional operating rooms or solely dedicated outpatient operating rooms, the ambulatory surgery methodology will not be employed. In these instances, the review will be primarily architectural. The definition of "procedures" was considered. It was determined that procedures should include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all procedures regularly thought of as surgeries. establishment or expansion of operating rooms solely dedicated to outpatient surgery, the hospital's current provision of outpatient surgery will be subtracted from the total of outpatient surgeries performed and then converted to an institution-specific rate and applied to projected population to determine the need. In the case of hospital ambulatory surgery projects not involving additional operating rooms or solely dedicated outpatient operating rooms, the ambulatory surgery methodology will not be employed. In these instances, the review will be primarily architectural. The definition of "procedures" was considered. It was determined that procedures should include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all procedures regularly thought of as surgeries. The method of computing the break even point was discussed. Tom Porter will work with Joe Mitchell to come up with an improved method for doing this. The issue of what year we project need to was discussed. It was decided that in all cases, the projection year would be based on the time shown in the application as required for construction and licensing of the facility plus two years from the date of the HRS review or date of administrative hearing, whichever is later. If you have any questions concerning this memorandum, please see me. /s/ Gene W. Eugene Nelson, Administrator COMMUNITY MEDICAL FACILITIES Petitioner's Exhibit B. The June memorandum supersedes the February memorandum but "not totally." Deposition of Marta Hardy, p. 10. The June memorandum made changes regarding the treatment of hospitals' applications. Deposition of Elizabeth Dudek, p. 23. On September 13, 1985, more than two weeks after the petitions had been filed in Cases Nos. 85-2962RX and 85-2963RX, Mr. Maryanski signed the following memorandum: SUBJECT: Policy Memorandums TO: PDCF (Liz Dudek) (Wayne McDaniel) (Paul Reilly) (Joe Mitchell) Policy memorandums are statements of the current policy of the Office of Community Medical Facilities, and the Department of Health and Rehabilitative Services, regarding the subject to which it is addressed. The policy at issue is in a state of development, and should not be considered to have reached a level of general applicability to all cases. This memorandum is not intended to dictate the out-come of action being taken on any given case, but rather represents a momentary picture of this policy as it has developed through cases previously encountered. In order to provide for reasonably consistent actions taken in similar instances in this office, please utilize this policy memorandum as a guideline, subject to change and development on a case basis. Respondent's Exhibit No. 1 At some point staff were told "if there are reasons to deviate [from the policy embodied in the June memorandum] that they should come and discuss those reasons with their supervisor or" (T. 73) Mr. Maryanski. At least some HRS staff adhere to the policy stated in the June memorandum. Deposition of Elizabeth Dudek, p. 28. But the only reasons for deviating from the policy set out in the Maryanski memorandum of June 6, 1985, are the very reasons that would justify deviation from duly promulgated administrative rules. (T. 77) Petitioner's Exhibit A, the June memorandum, has application statewide and is addressed to all applications for certificate of need for ambulatory surgical centers. (T. 77) Without this policy in effect, "the only means [HRS] would have available would be to review am-surg applications according to statutory criteria." (T. 73) HRS has assigned to its Office of Comprehensive Health Planning, not to its Office of Community Medical Facilities (headed by Mr. Maryanski and, before him, by Mr. Nelson), responsibility for promulgating administrative rules. On July 6, 1984, HRS published notice of intent to adopt a rule governing applications for certificates of need for ambulatory surgical centers, at 10 Florida Administrative Weekly No. 27, pp. 2064-2067. Petitioner's Exhibit C. Additional or amended notice was published on March 15, 1985, at 11 Florida Administrative Weekly No. 11. After petitions challenging HRS' proposed rule 10-5.11(30) were filed, HRS abandoned the effort formally to adopt a rule specifying the criteria for granting certificates of need for ambulatory surgical centers, by filing notice of withdrawal with the Department of State on June 20, 1985. On deposition, HRS' Deputy Assistant Secretary for Health Planning testified that the June "memo was issued right after we withdrew the rule." At 6. Although in fact the notice of withdrawal of proposed rule 10-5.11(30) was not filed until after the June 6 memorandum was executed, the decision to withdraw the proposed rule, to judge from this testimony, antedated the memorandum which "in the absence of any kind of methodology, [HRS] decided to issue. . . to provide methodology guidelines to the staff within the office." Deposition of Marta Hardy, p. 6.
The Issue The issue for determination in this proceeding is whether the Respondent, the Department of Professional Regulation, should pay the Petitioner, Kirk A. Woodson, M.D., attorney fees and costs under Section 57.011, Fla. Stat. (1989), the Florida Equal Access to Justice Act. As reflected in the Preliminary Statement, the parties stipulate that the Petitioner is a "prevailing small business party" and that reasonable fees and costs exceed $15,000, the statutory cap. The only remaining issue under the statute is whether the Respondent was "substantially justified" in filing the Administrative Complaint in Case No. 90- 5986 against the Petitioner. 1/
Findings Of Fact On or about June 7, 1988, a complaint was filed against the license of the Petitioner, Kirk A. Woodson, M.D., subsequent to closure of a professional malpractice liability claim against him without payment of indemnity. The substance of the complaint was that, on January 1, 1986, Woodson saw and performed a hysterectomy on a patient who had presented at the emergency room at University Community Hospital in Tampa, Florida, with heavy and continuous vaginal bleeding. The complaint stated that post-surgery the patient developed Adult Respiratory Distress Syndrome (ARDS) and died. The complaint questioned whether Woodson failed to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. By letter dated June 30, 1988, the Department of Professional Regulation (the Department or DPR) notified Woodson that it had received the complaint and that it was initiating an investigation. DPR subpoenaed the hospital records which revealed that the patient arrived at the UCH emergency room at 5:28 a.m. on January 1, 1986, with at least a three-day history of vaginal hemorraging. An emergency room physician saw the patient, gave her two units of packed blood cells, and admitted her to Woodson's service. Woodson was called at approximately 8:30 a.m. and saw the patient later that morning. The patient's admission to surgery to determine the cause of the bleeding and perform necessary procedures was delayed until at least approximately 2:00 p.m. because the patient refused to consent to a dilation and curettage (D and C); she was insisting on a hysterectomy only. She finally consented to a D and C to be followed by a hysterectomy if Woodson found it to be medically necessary. During this delay, the patient continued to bleed and was transfused with two more units of packed blood cells at approximately 1:45 p.m. After the consent was given, there was a further delay, not explained by the records, until approximately 6:00 p.m. in getting the patient to surgery. The patient continued to bleed. Surgery took almost five hours. During surgery, the patient's bleeding got worse, and she was transfused with four more units of whole blood during the surgery. The DPR investigator was unable to ascertain from the hospital records the reason for the length of the surgery. The DPR investigator attempted to arrange an interview with Dr. Woodson and his attorney on or about February 28, 1989. The appointment was cancelled. When the DPR investigator contacted Woodson to reschedule the interview, Dr. Woodson questioned why DPR was pursuing the complaint when the malpractice claim was closed without payment of indemnity. Dr. Woodson agreed to be interviewed but expressed his preference that the investigator first review the "extensive depositions" taken in the malpractice litigation. 4/ Having already determined to request an expert evaluation of the case, the investigator decided to postpone the interview with Dr. Woodson. On July 10, 1989, the DPR asked a probable cause panel of the Board of Medicine to authorize the retention of an expert in gynecology to review the information obtained through investigation to that point in time to assist in the determination whether Woodson's treatment of the patient fell below that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. On July 22, 1989, the probable cause met and authorized the expert review. On or about November 2, 1989, the DPR requested an expert review by Doris N. Carson, M.D., a Board-certified gynecologist with extensive surgical experience, including emergency room experience. Dr. Carson reviewed the hospital records supplied by DPR, some of which were difficult to read. By letter dated November 20, 1989, Dr. Carson reported her impressions. Dr. Carson believed the records supported Dr. Woodson's diagnosis and ultimate course of treatment. In the patient's condition, the proper course of treatment was to attempt to stop the vaginal bleeding by doing a D and C; a hysterectomy only should have been attempted if the D and C did not stop the bleeding. However, Dr. Carson perceived other problems that were not explained to her satisfaction by the hospital records. First, Dr. Carson did not see anything in the records to justify the length of the surgical procedures performed by Dr. Woodson. She reported: Careful review indicated that the subject attempted to remove the fibroids vaginally, and when this only increased the bleeding, then decided to do a laparotomy. The uterus, although enlarged, was not huge and the procedure as described seemed to move along without difficulty. When, however, the time is reviewed five hours would indicate very serious problems of technique or what seems more likely a lot if indecision about how to proceed. Evidently there was no physician surgical assistant, and the subject proceeded alone. In retrospect better operationg room help should have been available. Second, Dr. Carson felt that the patient received too much whole blood replacement during the course of the day and the surgery. Her reading of the hospital records indicated to her that five units of whole blood were given to the patient in addition to four units of packed cells. She felt: "Packed cells altogether would have been a better choice in light of the volume given to the patient." Her concern was that "volume overload," rather than ARDS, may have resulted ultimately in the death of the patient. However, she disclaimed the necessary expertise to render a conclusive opinion on the question and recommended that, if the DPR wanted a conclusive opinion on the cause of death, it should have a specialist in intensive care or a respiratory expert review the records. Dr. Carson had some difficulty with the delay in getting the patient to the operating room. The records indicated that at least some of the delay was caused by the patient's unwillingness to give consent to the recommended D and C. But Dr. Carson nonetheless had concerns that the delay added to the amount of blood transfused. Dr. Carson closed her letter with this remark: "In conclusion: A poorly done sugical proceeding below the recognized normal level of care." For reasons not apparent from the evidence presented, DPR did not interview Dr. Woodson before asking the probable cause panel to find probable cause and file a draft Administrative Complaint against Dr. Woodson based on Dr. Carson's expert review and the rest of the investigative report, including the hospital records. The draft Administrative Complaint, drawn in two counts, sought to discipline Dr. Woodson under Count I for failure to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances, in two respects: first, for allegedly causing volume overload in the patient by ordering units of whole blood, instead of packed blood, to replace the patient's blood loss; and, second, for allegedly taking too long, without justification, to perform the necessary surgery. Count II alleged that Woodson failed to keep written medical records justifying the course of treatment of the patient, specifically with respect to ordering whole blood instead of packed units and with respect to the length of the surgical procedures. The probable cause panel considered the matter at its meeting on June 22, 1990. Counsel for the panel pointed out that the "extensive depositions" Woodson had indicated he wanted the DPR investigator to read before Woodson was interviewed were not in the packet of materials reviewed by the panel. 5/ But members of the panel indicated that they had reviewed the material that was in the packet and that they thought the information contained in it was adequate to make a probable cause determination. One of the doctors on the panel called it a "horrendous case." She felt that Woodson had "swamped out the patient" and had performed "inappropriate types of fluid therapy and blood therapy." The other member mentioned the "five-hour operating time . . . without any real explanation." The panel's attorney pointed out the part of the report of investigation that referenced the patient's refusal to consent to Dr. Woodson's proposed surgery and asked whether it constituted "any semblance of an explanation for a delay?" It is not clear from the transcript of the probable cause proceeding how the panel resolved the attorney's question, but the panel voted to find probable cause notwithstanding the question. 6/ There is information in the materials reviewed by Dr. Carson, and by the probable cause panel, which tends to explain some of the time it took for Dr. Woodson to perform surgery on the patient. Some of this partially exculpatory information was difficult to read and decipher in the records. Some of the partially exculpatory information was acknowledged by Dr. Carson and may also have been taken into account independently by the panel. Notwithstanding this partially exculpatory information in the record, the finding of probable cause was substantially justified.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: Surgical Services of Tampa, Inc. (SST) is a wholly owned subsidiary of Surgical Services, Inc., (SSI) located in Orlando, Florida. Eighty percent of SSI is owned by American Medical International, Inc. (AMI), the third largest health care provider in the United States. The remaining twenty percent ownership of SSI is held by Randall M. Phillips, who also serves as the president of SST. AMI owns and operates some 70 acute care hospitals in the United States and abroad, a nursing home and 7 or 8 ambulatory surgery centers around the country. Two of these centers are located in Florida, one in Clearwater and one in Tallahassee, and SSI has the responsibility for these centers. SSI also holds several Certificates of Need for other free standing ambulatory surgery centers to be constructed in Florida. AMI has made a commitment to provide financial support for the total development of the applicant's proposed ambulatory surgery facility in Tampa. This support includes the purchase of the land, construction of the building, equipping the facility and working capital. The financing is to be in the form of a fifty percent equity contribution and a 28-year loan at 12 percent interest to SST for the remaining funds. AMI has sufficient financial resources to fulfill its commitment to the proposed project. The total projected cost for the proposed facility is $2,240,800.00. The parties have stipulated that the proposed costs associated with construction, equipment and land acquisition and preparation are reasonable. The parties have also stipulated that the proposed staffing pattern is adequate and that the applicant SST will have the ability to adequately staff the proposed facility. While SST had not made a firm site selection at the time of the hearing, it has plans to locate its facility somewhere near the vicinity of St. Joseph's Hospital and the Human Women's Hospital in Tampa, Florida. Its service area includes all of Hillsborough County. The center will consist of four operating rooms or surgical suites, and laboratory, x-ray and administrative areas for a total of 15,000 square feet. SST plans to handle all types of surgical procedures which can be performed on an outpatient basis. Its medical staff will be open to all doctors qualified to perform the types of surgeries that can be accomplished on an ambulatory, outpatient basis. The facility will admit any patient a surgeon schedules for surgery, and will accept Medicare and Medicaid patients. SST plans to invoke an aggressive marketing effort to inform and educate consumers, insurance companies, employers, physicians and other health care facilities in the market area as to the benefits and cost- effectiveness of using its facility to perform surgery on an outpatient basis. It has budgeted some $20,000.00 to effect such a marketing program. Professional accreditation with the Joint Commission on Accreditation of Hospitals will be sought after the proposed facility completes its first year of operation. Based upon a 15 percent Medicare utilization or patient mix and using the lowest Medicare reimbursement level and a projected number of procedures of 2,234 and 2,681 for the first and second years of operation, SST projects that it will have a loss of $17,426 in its first year of operation and a profit of $22,173 in its second year of operation. Using the highest payment level in the amount of contractual allowances, SST's pro forma statement shows a net income in both years of $689 and $41,444, respectively. The projected Medicare utilization percentage of 15 percent was not demonstrated to be erroneous and approximates the Medicare mix experienced at the petitioner's ASC facility in the preceding year. The projection of 2,234 procedures to be performed in the first year of operation was derived by estimating the number of potential ambulatory surgeries in the proposed service area (approximately 30 percent of all surgeries) and subtracting therefrom the number currently being performed in hospitals (approximately 15 percent), leaving a projected unmet caseload of 2,234. The salary projections, which were adjusted for inflation under the assumption that the proposed facility would begin operations in August of 1984, appear to be reasonable and adequate. In the 1981-82 reporting period, approximately 58,000 total surgical procedures were reported in Hillsborough County. Of this number, approximately 82 percent were performed on an inpatient basis, while 18 percent were performed on an outpatient basis. The literature on the subject, as well as some other states, predicts that between 28 percent and 48 percent of all surgeries could be performed in ambulatory settings. In Salt Lake City, Utah, 38.2 percent of all surgeries are performed on an outpatient basis. A wider acceptance on the part of patients, consumers and physicians of the concept of performing surgery on an outpatient basis, as well as changes in third party reimbursement (including the new Medicare reimbursement system of payment based on diagnostic related groupings as opposed to lengths of hospital stay), should result in the performance of an increased percentage of surgeries on an outpatient basis. The applicant's expert ambulatory surgical facilities health planner utilized four different methodologies to evaluate the need for additional ambulatory surgery facilities in Tampa. The first methodology utilized was use rate-based and took into account population and historical surgery utilization data. Using the assumption that 30 percent of all surgeries performed can be performed in an ambulatory setting, projecting the number of surgeries expected in 1984 and subtracting the number performed on an outpatient basis in the last reporting period (1981-82), it was determined that the remaining unmet need in 1984 would be 8,226 ambulatory surgeries, and the respective figures for 1985 and 1986 would he 8,596 and 8,955. A flaw in this methodology is the assumption that existing facilities will not increase their usage of outpatient surgical procedures. The second methodology is also use rate-based, but predicts an increased performance of outpatient procedures by existing facilities, said increase approximating the percentage of population growth, assumes a 30 percent to 40 percent outpatient to inpatient ratio and produces a range of unmet need in 1984 of 7,586 to 13,753, in 1985 of 7,737 to 14,028, and in 1986 of 7,885 to 14,295. The third method is a use rate and capacity-based methodology. It also uses the 30 percent to 40 percent range as the potential ambulatory surgery market and then designates a number of dedicated operating rooms which would be appropriate to fill that need. Assuming that an average capacity is 1,200 procedures per room per year and that all current ambulatory surgeries are performed in dedicated ambulatory surgery suites, and then dividing that capacity figure into the number of expected ambulatory surgeries in 1984, the required number of dedicated operating rooms ranges from 16 to 21 in 1984 and 1985 and from 17 to 22 in 1986. Assuming 9 current dedicated ambulatory surgery operating rooms, the net need is determined as a range from 7 to 12 additional dedicated rooms in 1984 and 1985 and from 8 to 13 in 1986. The fourth methodology is similar to the first, but is based on patient day utilization. It uses a 30 percent outpatient to inpatient ratio, and yields an unmet need, after subtracting current procedures performed at existing facilities, of 8,221 procedures in 1984, 8,591 in 1985 and 8,950 in 1986. Each of the methodologies results in a sufficient number of outpatient surgical procedures to support the applicant's proposed surgery center. The respondent HRS has no promulgated rule prescribing the methodology to be utilized to determine the need for additional ambulatory surgical centers in an area. Its non-rule methodology, utilizes a use rate per 1,000 population for a given year, applies that to a projected population two and three years into the future and then multiplies that figure by 29 percent. The 29 percent represents a midrange between 18 percent and 40 percent, the range suggested by the literature as representing the percentage of total surgeries that can be performed on an ambulatory basis. Taking into account the existing outpatient use rate being experienced, the projected population and the projected number of outpatient procedures which will be provided by existing facilities, a total number of outpatient procedures that could be performed by an applicant is produced. The Department also considers the number of procedures an applicant would have to perform in order to break even financially in its second year of operation. This methodology relates need to financial feasibility, but does not consider capacity or optimum utilization factors. In this case, the use of HRS's methodology results in a total figure of 7,569 outpatient procedures that need to be provided in 1986 beyond those that would be provided by the existing outpatient facilities of the area hospitals. The HRS calculations do not consider those procedures being performed at the petitioner's ASC facility. HRS calculated that SST would have to perform 2,463 procedures by the year 1986 in order to break even financially, and therefore that there were a significant number of procedures available to support the need for an additional ambulatory surgery facility. Existing hospitals in Hillsborough County currently perform surgery on an outpatient basis. As indicated above, some 18 percent of all surgeries, or 10,276 procedures, were reported as outpatient in the 1981-82 reporting period by Hillsborough County facilities, including the petitioner. With the exception of the petitioner's four dedicated operating rooms and two more at an area hospital, the remaining existing operating rooms are not used exclusively for outpatient surgeries, but are available for such surgery. Many existing hospitals are currently in the process of expanding their outpatient services. These expansion efforts generally involve new pre-admission, pre-operative and recovery room beds and reception areas for ambulatory surgical patients, and not new dedicated operating rooms for outpatients. Among those receiving recent Certificates of Need to expand their outpatient services are Tampa General Hospital, St. Joseph's Hospital, Brandon Community Hospital and Humana's Women's Hospital. University Community Hospital is also active in the performance of outpatient surgical procedures. Depending upon the sufficiency and efficiency of management and staff, a freestanding ambulatory surgery center offers some advantages over outpatient surgery performed in a hospital operating room utilized for both inpatients and outpatients. The freestanding facility may have staff surgeons and anesthesiologists with specialized outpatient surgery training. Total overhead costs are likely to be less, thus resulting in reduced patient costs. Since the operating room staff effort is continually focused on outpatient surgery only, management problems may be reduced, thus making the experience more pleasant for the patient, his family and the surgeon. Patients will experience less waiting times as there will not be as many emergencies as in a hospital setting or as much "bumping" of an elective surgery outpatient in an ambulatory center. If properly and efficiently managed, there may be less danger of cross-infection in the freestanding facility. The petitioner ASC is a freestanding facility built in 1979 and located adjacent to the University of South Florida in Tampa. It occupies 14,350 square feet, has four operating rooms, a special procedures room, several examination rooms, 12 recovery beds, 8 pre- and post-operative beds, waiting rooms and administrative and business office areas. Staff privileges are held by 157 surgeons from the Tampa area. At the time of the hearing, 15 more surgeons had applied for staff privileges. Its total caseload for the first eleven months of operation was 257. Cases performed in 1980 increased to 420. In 1981 and 1982, ASC performed 1,172 and 1,217 procedures, respectively. For the first seven months of 1983, 1,191 procedures were performed, for a utilization rate of approximately 25 percent. ASC has no formal, regular budgeted marketing program. It has received accreditation from the Joint Commission on Accreditation of Hospitals.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that HRS issue a Certificate of Need to Surgical Services of Tampa, Inc. to construct and operate a freestanding, four operating room ambulatory surgery center in Hillsborough County. Respectfully submitted and entered this 22nd day of March, 1984, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of March, 1984. COPIES FURNISHED: F. Phillip Blank and Robert A. Weiss, Esquires 241 East Virginia Street Tallahassee, Florida 32301 Claire D. Dryfuss, Esquire Assistant General Counsel 1323 Winewood Blvd. Tallahassee, Florida 32301 Fred W. Baggett and Michael J. Cherniga, Esquires 101 East College Avenue P.O. Drawer 1838 Tallahassee, Florida 32301 David Pingree Secretary Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of August, 2005.
