The Issue Did the Respondent commit the violations alleged in the Amended Administrative Complaint dated March 2, 2001, and if so, what penalty should be imposed?
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: The Board is the agency charged with regulating the practice of medicine in the State of Florida. Respondent, Carl W. Liebert, Jr., M. D. (Dr. Liebert) is and, at all times material hereto, has been licensed to practice medicine in the State of Florida, having been issued license number ME0047601. Respondent is Board-certified in surgery. On January 29, 1997, Respondent performed an abdominal aortic aneurysm repair and an aortobifemoral graft on E. T., a male patient, approximately 70 years of age. The site of the graft for the left femoral artery intruded partially upon the site of a previous graft of the femoral artery performed in 1986. This graft failed immediately after the procedure. Respondent sutured the graft at the left femoral artery partially into old scar tissue from the 1986-failed graft. After the surgery, on the Sunday before his release from the Naples Community Hospital (Hospital) on Thursday, February 6, 1997, E. T. suddenly and abruptly fell in his hospital room. Respondent was concerned about the possible damage this fall may have caused to the surgical repair. Although E. T. experienced pain in his left groin area, the location of one of the aortobifemoral grafts, while in the Hospital, there is no evidence that any harm resulted from the fall or that the pain was a result of the fall. After the surgery, during E. T.'s stay in the Naples Community Hospital (Hospital), there was lymphatic drainage, a pinkish colored fluid, from the incision in his left groin. While the lymphatic fluid may have been blood stained resulting in the pinkish color, the lymphatic drainage was not as described in the nurse's notes as being "a bloody discharge." On Thursday, February 6, 1997, E.T. was discharged from the Hospital. After E. T.'s discharge from the Hospital, his wife cared for him in their home in Naples, Florida. As expected by Dr. Liebert, the incision in E. T.'s left groin area continued to have lymphatic drainage after E. T.'s discharge from the Hospital. The incision in E. T.'s left groin area continued to drain a pinkish colored fluid. The lymphatic drainage from the incision in E. T.’s left groin continued over the weekend and on Monday, February 10, 1997, E. T.'s wife contacted Respondent's office to advise Respondent of the drainage and of the pain E. T. was experiencing. Although E. T.'s wife did not speak directly to Respondent, she assumed that the person to whom she spoke with over the telephone conveyed her message to Respondent. E. T.'s wife was given a prescription for Percocet for pain and told that Respondent would see E. T. in his office on Thursday, February 13, 1997. On Wednesday, February 12, 1997, while showering and cleansing the incision on his left groin, E. T. inadvertently disturbed the incision on his left groin, which caused the incision to drain profusely. After leaving the shower, E. T.'s wife assisted E. T. in drying-off his body and controlling the drainage from the incision. The wife stemmed the flow of the drainage with a towel and called the Collier County Emergency Medical Services (EMS) and Respondent's office. The wife explained to the person answering Respondent's telephone, the circumstances of the occurrence with E. T., and that she had called the Collier County EMS personnel. The wife also requested that Respondent come to the Hospital. On February 12, 1997, in response to E. T.'s wife's call, the Collier County EMS personnel responded to E. T.'s home at approximately 7:25 a.m., performed an initial treatment for the drainage from E.T.'s left groin and transported E. T. by ambulance to the Hospital. The EMS personnel noted that E. T. complained of bleeding and it was their initial impression that E. T. was bleeding from his femoral artery. However, the EMS personnel did not confirm that E. T. was bleeding from his left femoral artery. The EMS personnel also noted what they considered to be a large amount of thick, clotty blood, which they estimated to be approximately 1000 milliliters (ml's) or 1000 cubic centimeters (cc's), surrounding E. T. Based on the records of the EMS personnel and on E. T.'s description given to Dr. Mulert, E. T.'s wife's testimony that the incision spurted blood for approximately 3- 4 feet appears to be somewhat exaggerated. The EMS personnel, assuming that E. T. had recently loss blood, administered 300 cc of fluid intravenously to E. T. When the EMS personnel attempted to move E. T., the drainage from the incision started again, but was controlled with a trauma dressing and pressure applied by a sandbag. The EMS personnel presented E. T. at the Emergency Room (ER) of the Hospital at approximately 7:52 a.m. on February 12, 1997. The ER nurse noted that a pressure dressing along with a sandbag had been applied and that the drainage or bleeding was under control. The ER nurse drew blood from E. T. and noted in her record that it was for a "type and cross" in preparation for a blood transfusion should one become necessary. However, Dr. Robert Mulert, the ER physician who attended E. T. while in the ER, noted in his records that he had requested a "type and hold," a less elaborate procedure than a "type and cross," which requires checking the antibodies and making sure the blood in question is compatible blood. Based on his estimate of E. T.'s blood loss and E. T.'s vital signs and other health conditions, Dr. Mulert did not consider E. T. as a patient in need of a blood transfusion. Upon E. T.'s arrival at the Hospital, Dr. Mulert made a brief assessment of E. T.'s condition to confirm that there was no active bleeding and that the patient did not need emergent intervention. Although Dr. Mulert is not a vascular surgeon or even a general surgeon, he has one year of residency training in surgery and is a Board-certified emergency room physician who has been working as an emergency room physician for approximately 27 years. Dr. Mulert is qualified to examine patients such as E. T. and advise the primary treating physician of his findings. Dr. Liebert has worked with, and relied on, Dr. Mulert's expertise as an emergency room physician in treating many of his patients who are presented at the Hospital for emergency treatment for approximately 15 years. Dr. Mulert discussed E. T.'s condition by telephone with Dr. Liebert on two separate occasions during E. T.'s visit to the Hospital on February 12, 1997. The first occasion was shortly after E. T. was admitted to the Hospital ER. During this first occasion, Dr. Mulert advised Dr. Liebert that his patient, E. T. had been admitted to the Hospital with a reported acute hemorrhaging or bleeding of the incision in the area of his left groin and that E. T.'s wife was asking for Dr. Liebert. In some instances, the primary physician will assume treatment at this juncture. However, it is not unusual for the ER physician to continue treatment. The decision was for Dr. Mulert to continue treatment and to keep Dr. Liebert advised as to E. T.'s condition. There is nothing in the record to indicate Dr. Liebert's location on the morning of February 12, 1997; nor is there any evidence to indicate that Dr. Liebert was prevented from examining E. T. on the morning of February 12, 1997. Also, during this first discussion, Dr. Mulert advised Dr. Liebert, based on the information that he had gathered, that E. T.'s blood loss was approximately 500 cc's but that there was no active bleeding at that time. Dr. Mulert also advised Dr. Liebert that he intended to deal with the patient's problems by proceeding with his plan to assess E. T.'s blood count, to monitor E.T.'s vital signs, and to see if the patient met Dr. Mulert's criteria for stability: Can he get up? Can he walk? Can he talk? Does the patient make sense? Does the patient have discharge stability? Subsequent to this first discussion, Dr. Mulert made a more detailed examination of the wound to determine if the wound was infected, the depth of the wound, and the need to pack the wound with sterile dressing, etc. After reviewing the EMS personnel records, E. T.'s history, talking with E. T., and reviewing the results of his examination, Dr. Mulert's impression was that E. T. had a hematoma under a surgical wound; that the wound had come apart; and that the collection of blood (old blood) within the hematoma had expressed from that surgical wound. The blood within the hematoma is referred to as "old blood" in that it was no longer in the vascular system and was not being replenished with oxygen. While E. T.'s vital signs were low compared to his vital signs taken while in the Hospital on visits prior to February 12, 1997, they were not significantly lower and were within a normal range for a patient, such as E. T., who was on beta blockers. E. T.'s vital signs were inconsistent with an aggressive femoral graft leak. The hematocrit and hemoglobin values on February 12, 1997, were slightly lower than the hematocrit and hemoglobin values while in the hospital during his most recent visit in January 1997. However, based on the testimony of Dr. Liebert, which I find to be credible, that was to be expected since E. T. had been given a significant amount of auto-transfused blood during his surgery on January 29, 1997. Also, the lower values were consistent with a 500 cc or less blood loss by a patient that had just recently undergone surgery. During either the first or second conversation, Dr. Mulert advised Dr. Liebert that the surgical site had come apart. During his care of E. T., Dr. Mulert became aware that Dr. Liebert had performed an abdominal aortic aneurysm repair earlier in the year, and that the repair was under the nine-inch incision on E. T.’s left groin but did not know the exact location of the repair. If Dr. Liebert made a diagnosis, he did not convey such diagnosis to Dr. Mulert. Neither Dr. Liebert nor Dr. Mulert discussed or made a differential diagnosis. However, it was the testimony of both Dr. Mulert and Dr. Liebert, which I find to be credible, that based on the facts presented in respect to E. T. by Dr. Mulert, a differential diagnosis was unnecessary. A differential diagnosis is a mechanism physicians use to identify and evaluate possible alternative causes for observed symptoms. During the second telephone conversation, Dr. Mulert advised Dr. Liebert that the patient had been stable for approximately four hours, that his vital signs were within normal ranges, that his blood counts were basically unchanged, that there was no active bleeding and had not been any active bleeding for approximately four hours, that the patient was up and walking around the ER, that the patient was asymptomatic when vertical that the patient was not orthostatic when walking, that the patient wanted to go home, and that the incision in the left groin area needed to be repaired. There was no discussion between Dr. Mulert and Dr. Liebert concerning the admission of E. T. to the Hospital for the purpose of further examining the possibility of arterial bleeding. Ultrasound and computerized tomography (CT) were available to patients at the Hospital. While these tests don't always "rule out" internal bleeding or suture line disruptions, they can, in certain instances, "rule in" these conditions. Based on the facts in respect to E. T.'s condition presented by Dr. Mulert on February 12, 1997, particularly that they were dealing with an open wound, and Dr. Liebert's feelings as to the somewhat limited use of these tests in this type situation, there was no ultrasound or CT scan performed. Based on the facts in respect to E. T.'s condition as presented by Dr. Mulert on February 12, 1997, the failure of Dr. Liebert to utilize the ultrasound or CT scan to further examine E. T. in regard to arterial bleeding does not constitute the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, notwithstanding the testimony of Michael J. Cohen, M.D. to the contrary. Subsequently, Dr. Mulert sewed up the incision which had come apart. Dr. Liebert did not personally examine E. T. at any time while he was in the ER to evaluate the cause of E. T.'s problem in relation to arterial bleeding, but relied on Dr. Mulert to provide him with facts surrounding E. T.'s condition based on Dr. Mulert's examination of E. T. and his assessment of E.T.'s problem. Based on the facts in respect to E. T.'s condition in relation to arterial bleeding as presented by Dr. Mulert on February 12, 1997, the failure of Dr. Liebert to personally examine E. T. prior to his discharge or to delay E. T.'s discharge so as to allow time for Dr. Liebert personally examine E. T. to determine for himself E. T.'s problem in relation to arterial bleeding does not constitute the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, notwithstanding the testimony of Michael J. Cohen, M.D. to the contrary. 38. E. T. was discharged from the Hospital at approximately 12:00 noon on February 12, 1997. After his discharge on February 12, 1997, E. T. had an uneventful afternoon and evening. After getting out of his bed on the morning of February 13, 1997, E. T. walked from his bedroom into the kitchen and as he stood in the kitchen the left groin incision erupted again, hemorrhaging blood onto the kitchen floor. The EMS personnel were called responded to the call around 5:30 a.m. Prior to the arrival of the EMS personnel the bleeding had stopped. The EMS personnel noticed a moderate blood loss. The EMS personnel dressed the left groin wound, administered fluids and transported E. T. to the Hospital where he was admitted to the ER at approximately 6:00 a.m. Although E. T. received blood and fluids, his condition deteriorated rapidly and E. T. expired at approximately 7:24 a.m. on February 13, 1997. No autopsy was performed. However, the cause of death was most likely myocardial infarction that resulted from a loss of blood.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board enter a final order dismissing the Amended Administrative Complaint dated March 2, 2001. DONE AND ENTERED this 1st day of August, 2001, in Tallahassee, Leon County, Florida. ___________________________________ WILLIAM R. CAVE 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) 921-6947 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of August, 2001. COPIES FURNISHED: Robert C. Byerts, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Ralph L. Marchbank, Jr., Esquire Post Office Box 3979 Sarasota, Florida 34230 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way Bin A00 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A00 Tallahassee, Florida 32399-1701
The Issue Whether any of the applications of Oak Hill Hospital, Citrus Memorial Hospital, or Brooksville Regional Hospital for adult open heart surgery programs should be granted?
Findings Of Fact District 3 Extended across the northern half of the state with a reach from central Florida to the Georgia line, District 3 is the largest in land area of the eleven health service planning districts created by the Florida Legislature. See Section 408.032(5), Florida Statutes. Sites of the three hospitals whose futures are at issue in this proceeding are in two of the sixteen District 3 counties: Citrus County and at the southern tip of the district, Hernando County. The three hospitals aspire to join the ranks of District 3's six existing providers of adult open heart surgery programs. Three of the existing providers are in Alachua County, all within the incorporated municipality of Gainesville: Shands at Alachua General Hospital, Shands at the University of Florida, and North Florida Regional Medical Center. Two of the existing providers are in Marion County: Munroe Regional Medical Center and Ocala Regional Medical Center. The sixth provider, opened in November of 1998 as the most recently approved by AHCA in the district, is in Lake County: the Leesburg Regional Medical Center. The CON status of the two Ocala providers is somewhat unusual. Located across the street from each other in downtown Ocala, they share virtually the same medical staff. Pursuant to a Stipulation and Settlement Agreement with the State of Florida, the two have offered adult open heart surgery services since 1987 under a single certificate of need issued for a joint program that reflects their proximity and identity of medical staff. The Agency's view of the arrangement has evolved over the years. It now holds the position that Munroe Regional and Ocala Regional operate independent programs. Accordingly, AHCA lists each as separate programs on its inventory of adult open heart services in District 3. Nonetheless, the two operate as a joint program pursuant to the Settlement Agreement and under state sanction reflected in the agreement, that is, they derive their authority to offer adult open heart surgery services from a single certificate of need. Other than a change of attitude by the Agency, there is nothing to detract from the status they have enjoyed since the agreement reached with the state in 1987: two hospitals operating a joint program under a single certificate of need. The three Gainesville providers all operated at an annual volume of less than 350 procedures during the reporting period that was most current at the time of the filing of the applications by the three competitors in this case. Those competitors are: Citrus Memorial, Oak Hill, and Brooksville Regional. Citrus Memorial, Oak Hill, Brooksville Regional Citrus Memorial Health Foundation, Inc., is a 171-bed, not-for-profit community hospital located in Inverness, Florida. HCA Health Services of Florida, Inc., d/b/a Oak Hill Hospital is a 204-bed hospital located in Oak Hill, Florida. Hernando HMA, Inc., d/b/a Brooksville Regional is a 91- bed hospital located in Brooksville, Florida. Hernando HMA, Inc. (the applicant for the program to be sited at Brooksville Regional) also operates a second campus under a single hospital license with Brooksville Regional. The 75-bed campus is in southern Hernando County in Spring Hill. Citrus and Hernando Counties Citrus Memorial is in Citrus County to the south of the cities of Gainesville and Ocala, the sites of five of the existing providers of adult open heart surgery in the district. Further south, Oak Hill and Brooksville Regional are in Hernando County. Although adjacent to each other along a boundary running east-west, the county line is a natural divide, north and south, with regard to service areas for open heart surgery. Substantially all Citrus County residents, including Citrus Memorial patients, receive open heart surgery and angioplasty services at one of the two Ocala providers to the north. In contrast, almost all Hernando County residents (94 percent) receive open heart services at Bayonet Point, a provider in Health Planning District 5 to the south of Hernando County. The neatness of this divide would be disrupted by the approval of the application of Brooksville Regional. Brooksville's application includes part of south Citrus County in its designated primary service area, an appropriate choice because of Brooksville Regional's location on Route 41 with good access to Citrus County. At present, however, the divide between north and south along the Citrus/Hernando boundary remains a Mason-Dixon line of open heart surgery service areas. During the year ended September 1999, for example, 408 Citrus County residents received open heart surgery in Florida. Of these, 85 percent received them in Ocala at one of the two providers there. During the same period, 618 Citrus County residents underwent angioplasty, with 89.7 percent of them going to the two Ocala providers. During the year ended March 1999, 698 Hernando County residents underwent open heart surgery at Florida Hospitals. Of the 663 residents of Oak Hill's primary service area, 94.3 percent received services at Bayonet Point in District 5. Similarly, of the 779 Oak Hill primary service area residents receiving angioplasty, 93.8 percent went south to Bayonet Point. Brooksville Regional projects that 10 percent of its OHS/angioplasty volume will be from Citrus County. Still, 90 percent of the volume is projected to be from Hernando County. Thus, even with the threat posed by Brooksville's application to the divide at the Citrus/Hernando boundary, the overwhelming percentage of Brooksville's patients will be from south of the Citrus-Hernando boundary. In sum, there is de minimis competition between would- be-provider Citrus Memorial and the providers to the north vis- a-vis would-be-providers Oak Hill and Brooksville Regional and the providers to the south in the arena of open heart surgery services needed by residents of the district. Bayonet Point Under the umbrella of HCA Health Services of Florida, Inc., Bayonet Point is a provider of open heart surgery services in Pasco County. Only thirty minutes by road from its sister HCA facility Oak Hill and 45 minutes from Brooksville Regional, Bayonet Point captures approximately 94 percent of the open heart surgery patients produced among the residents of Hernando County. Although its location is in a county that is only one county to the south of the two Hernando County hospitals, Bayonet Point is in a different health planning district. It is in District 5 on its northern edge. The residents of Hernando County who receive open heart surgery services at Bayonet Point, a premier provider of adult open heart surgery services in the state of Florida, are well served. Operating at far from capacity, the quality of its open heart program is excellent to the point of being outstanding. Position of the Parties re: "not normal" circumstances The Agency's Open Heart Surgery Rule, Rule 59C-1.033, Florida Administrative Code (the "Rule") establishes a need methodology and criteria applicable to review of certificate of need applications for the establishment of adult open heart surgery programs. The Rule also governs a hospital's ability to offer therapeutic cardiac catheterization interventional services (i.e., coronary angioplasty). Pursuant to Rule 50C- 1.032, Florida Administrative Code, a cardiac catheterization program that includes the provision of coronary angioplasty must be located within a hospital that provides open heart services. Applying the methodology of Rule 50C-1.033 (the "Rule"), AHCA determined that a "fixed need pool" of zero existed in District 3 for the July 2002 planning horizon. Calculation under the formula in the Rule produced a fixed need pool of one. Several District 3 programs, however, did not have an annual case volume of 350 or more procedures. The Rule's methodology requires that calculated numeric need be zeroed out whenever there are existing programs in a district with a sub- 350 annual volume. (See Section (7)(a)2., of the Rule.) As required, therefore, the Agency published a numeric need of zero for the applicable planning horizon. The determination of zero numeric need was not challenged and so became final. Their aspirations confronted with a numeric need of zero, Citrus Memorial, Oak Hill and Brooksville Regional, nonetheless, each filed applications seeking the establishment of adult open heart surgery programs. As evidenced by the Agency's initial decision to grant Citrus Memorial's application and by its change of position with regard to Oak Hill's application, the Agency is in agreement that "not normal" circumstances exist to justify granting the applications of both Citrus Memorial and Oak Hill. Thus, while the parties may differ as to the precise identification of those circumstances, all agree that there are circumstances that support the approval of at least one application (and perhaps two) for an adult open heart surgery in District 3 for the July 2002 planning horizon. It is undisputed that a new OHS program in Hernando County would have no effect on the three existing programs located in Gainesville that perform less than 350 procedures annually. This circumstance is a "not normal" circumstance, as previously found by the Agency. It allows an application's approval in the face of the Rule's dictate that the Agency will not normally approve an application when an existing provider falls below the 350 watermark. It is not, however, a circumstance that compels the award of a CON to any of the parties as in the case of "not normal" circumstances typically recognized by the Agency. (An example of such a circumstance would be an access problem for a specific population.) Rather, it is a circumstance that allows the Agency to overcome the zeroing-out effect of the Rule that demanded a fixed-need pool of zero. It is a circumstance that allows AHCA to award an adult open heart surgery CON to one of the Hernando County hospitals provided there is a demonstration of need. There are no typical "not normal" circumstances that support any of the applications. There are no geographic, economic or clinical access problems for the residents of the any of the primary service areas of the three applicants that rise to the level of "not normal" circumstances. Nor would granting the applications of any of the three support cost efficiencies. In the case of Oak Hill, moreover, granting its application would both reduce the operating efficiencies at Bayonet Point and increase the average operating cost per case at Bayonet Point. Approval of an application is not compelled by the "not normal" circumstance that exists in this case. The "not normal" circumstance simply clears the way for approval provided there is a demonstration of need. Stipulated Matters The parties stipulated that all applicants have a good record of providing quality of care and that all sections of the respective applications addressing that issue be admitted into evidence without further proof so as to establish record of quality of care. Accordingly, the parties stipulated that each application satisfies Section 408.035(1)(c) as to "the applicant's record in providing quality of care." The parties stipulated that, subject to proving their ability to generate the open heart surgery and angioplasty volumes projected in their respective applications, each applicant has the ability to provide adequate and reasonable quality of care for those proposed services. Accordingly, subject to the proof involving service volume levels, each application satisfies Section 408.035(1)(c) as the "ability of the applicant to provide quality of care . . .". The parties stipulated that all applicants have available and adequate resources, including health manpower, management personnel, and funds for capital and operating expenditures in order to implement and operate their proposed projects. Furthermore, they stipulated that all sections of their respective applications relating to those proposed projects and all sections of their respective applications relating to those issues were to be admitted into evidence without proof. Accordingly, all applications satisfy that portion of Section 408.035(1)(h), Florida Statutes (1999) related to the availability of resources. The parties stipulated that all applications satisfy, and no further proof is required to demonstrate, immediate financial feasibility as referenced in Section 408.035(1)(i), Florida Statutes (1999). The parties stipulated that the costs and methods of proposed construction, including schematic design, for each proposed project were not in dispute and were reasonable, and that all sections of each application related to those issues were to be admitted into evidence without further proof. (Stip., p.3.) Accordingly, each application satisfies Section 408.035(l)(m), Florida Statutes (1999). The parties stipulated that each application contained all documentation necessary to be deemed complete pursuant to the requirements of Section 408.037, except that Section 408.037(b)3. is still at issue regarding operational financial projections (including a detailed evaluation of the impact of the proposed project on the cost of other services provided by the applicant). The parties stipulated that each applicant satisfied all of the operational criteria set forth in the Rule (those operational criteria being encompassed in subsections 3, 4, and 5). Accordingly, it is undisputed that each applicant will have the support services, operational hours, open heart surgery team mobilization, accreditation, availability of health personnel necessary for the conduct of open heart surgery, and post- surgical follow-up care required by the Rule in order to operate an adult open heart surgery program. The Hernando County Hospitals Oak Hill Oak Hill is located on Highway 50, in the southern part of Hernando County, between the cities of Brooksville and Springhill. Oak Hill's licensed bed compliment includes 123 medical/surgical beds, 24 ICU beds, 50 telemetry beds, and 7 beds for obstetrics. Oak Hill provides an array of medical services and specialties, including: cardiology, internal medicine, critical care medicine, family practice, nephrology, pulmonary medicine, oncology/hematology, infectious disease treatment, neurology, pathology, endocrinology, gastroenterology, radiation oncology, and anesthesiology. Board certification is required to maintain privileges on the medical staff of Oak Hill. Oak Hill's six-story facility is situated on a large campus, and has been renovated over time so that the hospital's physical plant permits the provision of efficient care for patients. Oak Hills's surgery department has five operating rooms, plus a cystoscopy room. The department performs approximately 7,800 surgeries annually, a figure that demonstrates functional efficiency. Oak Hill is JCAHO accredited, with commendation. Recently named one of the nation's top 100 hospitals for stroke care by one organization, it has also received recognition for the excellence of its four intensive care units. Oak Hill's cancer program is the only one to have received full accreditation from the American College of Surgeons within a six-county contiguous area. Oak Hill recently expanded its emergency department and implemented a fast track program called Quick Care. The program is designed to treat lower acuity patients more rapidly. Gallup Organization surveys reflect a 98 percent patient satisfaction rate with the emergency department, the eighth best rate among the approximately 200 HCA-affiliated hospitals. During 1999, the emergency department treated 24,678 patients. During the same period, 376 patients presented to Oak Hill's emergency department with an acute myocardial infarction, and there were 258 such patients during the first eight months of 2000. Oak Hill operates a mature cardiology program with ten Board-certified cardiologists on staff. Eight of the ten perform diagnostic cardiac catheterizations in the hospital's cath laboratory. Oak Hill's program is active with regard to both invasive and non-invasive cardiology. The non-invasive cardiology laboratory offers a variety of services, including echocardiography, holter monitoring, stress testing, electrocardiography, and venous, arterial and carotid artery testing. The invasive cardiology laboratory has been providing inpatient and outpatient cardiac catheterization services since 1991. During calendar year 1999, Oak Hill saw 1,671 diagnostic cardiac catheterization procedures and transferred 619 cardiac patients to Bayonet Point, 258 for open heart surgery, 311 for angioplasty, and 50 patients for cardiac catheterization. The volume of catheterization procedures at Oak Hill has led to the construction of a second "cardiac cath" laboratory suite, scheduled for completion in May of 2001. The cath lab's medical director (Dr. Mowaffek Atfeh, the first interventional cardiologist in Hernando County) has served in that capacity since inception of the lab in 1991. The cath lab equipment is state-of-the-art. Oak Hill's cath lab provides excellent quality of care through its Board-certified cardiologists and the dedication and experience of its well- trained nursing and technical staff. Brooksville Regional Originally a 166-bed facility operated by Hernando County, 75 of the beds at Brooksville Regional were moved in 1991 to create a second facility at Spring Hill. A few years later, the facilities went into bankruptcy. The bankruptcy proceeding concluded in 1998, with operational control of both facilities being acquired by Hernando HMA, Inc. ("Hernando HMA"). The CON applicant for the adult open heart surgery program to be sited at Brooksville Regional, Hernando HMA is a wholly-owned subsidiary of Health Management and Associates, Inc. ("HMA"), a corporation located in Naples, Florida, and whose shares are traded publicly. Under the arrangement produced by the bankruptcy proceeding, Hernando County retained ownership of the buildings and the land. Hernando HMA, in turn, operates the facilities per a long-term lease with the County. Hernando HMA operates the Brooksville Regional and Spring Hill Campuses under a single hospital license issued by AHCA. The two campuses therefore share key administrative staff, including their chief executive officer. They share a single Medicare provider number and they have a common medical staff. HMA (Hernando HMA's parent) operates 38 hospitals throughout the country, many in the State of Florida. Among the 38 is Charlotte Regional Medical Center in Charlotte County, an existing provider of adult open heart surgery and recently recognized as one of the top 100 OHS programs in the country. Charlotte Regional will be able to assist Brooksville Regional with staff training and project implementation if its application is approved. An active participant in managed care contracting, Hernando HMA is committed to serving all payer groups, including Medicaid and indigent patients. It recently qualified as a Medicaid disproportionate share provider. It also serves patients without ability to pay. In fiscal year 2000, it provided $5 million of indigent care. Under the lease agreement Hernando HMA has with Hernando County, it must continue the same charity care policies as when the facilities were operated by the County. Hernando HMA must report annually to the County to show compliance with this charity care obligation. Also under the lease, Hernando HMA is obliged to invest $25 million in renovations and improvements to the two facilities over a 5-year period. About $10 million has already been invested. If the adult open heart surgery program is granted this would nearly satisfy the $25 million obligation. The County reserves to itself certain powers under the lease. For example, the County reserves the authority to pre- approve the discontinuation of any services currently offered at these facilities. Also, if Hernando HMA seeks to relocate either of the two, the County retains the authority whether to approve the relocation. The Spring Hill facility is located in the southwest portion of Hernando County, very near the Pasco County line. It is a general acute care facility, offering a full range of cardiology and other acute care services. Spring Hill was recently approved to add the tertiary service of Level II Neonatal Intensive Care. The Brooksville facility is located in the geographic center of Hernando County. Its service area is all of Hernando County and southern Citrus County. Brooksville is a full- service, general acute care facility. It offers services in cardiology, orthopedics, general surgery, pediatrics, ICU, telemetry, gynecology, and other acute services. Brooksville Regional has 91 acute care beds. Normally, the beds are used as 12 ICU beds, 24 telemetry beds, and 55 medical/surgical beds. During its peak annual period of occupancy, Brooksville has the capability to use up to 40 beds for telemetry purposes. The hospital has ample unused space and facilities associated with its 91 beds that resulted from the move of the 75 beds to create the Spring Hill campus. Brooksville Regional offers full scope cardiology services and technologies, including diagnostic cardiac catheterization. Just as in the case of Oak Hill, the cardiac cath lab is state-of-the-art. The only cardiac services not offered at the hospital are open heart surgery and angioplasty. The quality of cardiology and related services at Brooksville Regional are excellent. The equipment, the nursing staff, the allied health professional staff, and the technology support services are very good. The medical staff is broad- based and highly qualified. Brooksville Regional offers substantial educational and training programs for its nursing staff and other personnel on staff. Brooksville Regional routinely treats patients in need of OHS or angioplasty services. Nearly 400 patients per year receive a diagnostic cardiac cath at Brooksville Regional and are then transferred for open heart surgery or angioplasty. The vast majority of these patients are transferred to Bayonet Point, about 45 minutes away. In addition to transfers of patients following diagnostic catheterization, Brooksville Regional transfers about 120 patients per year to Bayonet Point who have not had such services. These patients fall into two categories: (1) high- risk patients, and (2) persons presenting at Brooksville's emergency room in need of angioplasty or open heart surgery. The Proposals Citrus Memorial By its application, Citrus Memorial proposes to establish a program that will provide adult open heart surgery and angioplasty services. There is no dispute that Citrus Memorial has the ability to provide adequate and reasonable quality of care for the proposed project (just as per the stipulation of the parties, there is no dispute that all of the applicants have such ability.) There is also no dispute that each applicant, including Citrus Memorial, will have all of the staff, equipment and other resources necessary to implement and support adult open heart surgery and angioplasty services. The ability to provide high quality care stems, in part, from Citrus Memorial's contract with the Ocala Heart Institute. Under the contract the Institute will provide supervision of the implementation and ongoing operations of the Citrus Memorial program. This supervision will be provided under the leadership of the president of the Institute, cardiovascular surgeon Michael J. Carmichael, M.D. The contract between Citrus Memorial and the Ocala Heart Institute is exclusive. Citrus Memorial will not extend medical staff privileges to any cardiovascular surgeon not affiliated with the Ocala Heart Institute unless approved by the Institute. The Ocala Heart Institute (whose physician members include not only cardiovascular surgeons, but also cardiovascular anesthesiologists and invasive cardiologists) has similar exclusive contracts for the operation of adult open heart surgery programs at Monroe Regional Medical Center and at Ocala Regional Medical Center and at Leesburg Regional Medical Center. At these three hospitals, the Institute's physicians have consistently produced excellent outcomes. The Ocala Heart Institute produces these results not just through the skills of its physicians but also through the use of the same clinical protocols at each hospital governing the provision of open heart surgery. Citrus Memorial proposes to follow identical protocols at its facility. Excellent open heart surgery outcomes for the Institute's physicians are also the product of standardized facility design, equipment and supplies. The standardization of design, equipment, supplies, and protocols has the added benefit of clinical efficiencies that reduce costs and shorten lengths of stay. Beyond supervision of the initial implementation of the program, the Ocala Heart Institute will provide the medical directorship for Citrus Memorial's program. In cooperation with Munroe Regional, the directorship's 24-hour-a-day, 7-days-a-week coverage of the program will include scheduled case, emergency case, and backup coverage by cardiovascular surgeons, cardiovascular anesthesiologists, perfusionists, and interventional cardiologists. The Ocala Heart Institute will provide education and training to Citrus Memorial's medical staff and other hospital personnel as appropriate. The Institute's obligations will include continually working to improve the quality of, and maintain a reasonable cost associated with, the medical care furnished to Citrus Memorial's open heart surgery and angioplasty patients, consistent with recognized standards of medical practice in the field of cardiovascular surgery. The contract with the Ocala Heart Institute ensures to the extent possible that Citrus Memorial will have a high- quality adult open heart surgery program. Oak Hill Through approval of its application to establish an adult open heart surgery program at its facility, Oak Hill hopes Hernando County residents who now must travel outside the county to receive open heart and angioplasty services will be better served. In particular, Oak Hill hopes to provide these services to the residents of the six zip code area that comprise its primary service area ("PSA"). Containing 75 percent of the county's population, Oak Hill's PSA also encompasses the county's concentration of recent growth. Oak Hill's administration is committed to the proposal contained in its application. It has the support of the hospital's Board of Trustees and medical staff. Not surprisingly, the proposal enjoys a measure of popularity in the county. A petition in support of a program at Oak Hill drew 7,628 signatures from residents of Hernando County. This popularity is based in the fact that residents now must leave District 3 (albeit Bayonet Point in District 5 is close to Oak Hill and closer for many residents of south Hernando County) to receive open heart and angioplasty services. The number of affected residents is substantial. In 1999, for example, over 600 cardiac patients were transferred by ambulance from Oak Hill to Bayonet Point. A greater number of patients traveled on a scheduled basis to Bayonet Point for cardiac care. The vast majority of Hernando County residents and Oak Hill primary service area residents in need of OHS services receive them at Regional Medical Center-Bayonet Point. HCA Health Services of Florida, a subsidiary of HCA-The Healthcare Company ("HCA") holds the Bayonet Point license. It also is the licensee of Oak Hill and other hospitals in Florida including North Florida Regional and Ocala Regional. Bayonet Point (Regional Medical Center-Bayonet Point) is an acute care hospital in Hudson. Hudson is in Pasco County, the county immediately to the south of Hernando County. Although in a separate health planning district (District 5), Bayonet Point is relatively close to Oak Hill, 17 miles to the south. Bayonet Point's open heart surgery program experiences the fourth highest case volume in the state. The program is recognized as one of the top two programs in the state. It enjoys a national reputation. For example in July of 1999, it was ranked 50th in the nation in cardiology and heart surgery in U.S. News and World Report's list of "America's Best Hospitals." Oak Hill, as a sister hospital of Bayonet Point under the aegis of HCA, plans to develop its program in cooperation with Bayonet Point and its cardiovascular surgeons so as to bring the high quality program at Bayonet Point to Oak Hill's community and patients. A prospective operational plan for the adult open heart surgery program has been initiated by Oak Hill with assistance from Bayonet Point. Oak Hill, unlike Citrus Memorial, did not present evidence concerning the specific duties to be imposed on each physician group under contract. Nor did Oak Hill present evidence as to whether and how those groups would create and implement the type of standardization of protocols, facility design, equipment, and supplies that Citrus Memorial's program will rely upon for high quality and reduced costs. Nonetheless, it can be expected that the cooperation of Oak Hill and Bayonet Point, as sister HCA hospitals, will continue through the development and implementation of appropriate staff training, policies, procedures and protocols in the establishment of a high quality program at Oak Hill. Oak Hill's achieved volume in its open heart surgery program, if approved, will be at the direct expense of Bayonet Point. Its approval will increase the operating costs per case at Bayonet Point. Patients transferred from Oak Hill to Bayonet Point for OHS and angioplasty receive excellent outcomes. Patients are transferred to Bayonet Point for OHS and angioplasty smoothly and without delay particularly because Bayonet Point operates a private ambulance system for the transport of cardiac patients to its hospital. Two groups of cardiovascular surgeons are the exclusive cardiovascular/thoracic surgeons at Bayonet Point. Although, at present, there are no capacity constraints at Bayonet Point, both groups support a program at Oak Hill and are committed to participate in an open heart surgery program at Oak Hill. If approved, Oak Hill will enter similar exclusive contracts with the two groups. Raymond Waters, M.D., a cardiovascular surgeon, heads one of the groups. He has performed open heart surgery at Bayonet Point since its inception and is largely responsible for the development of the surgery protocols used there. Dr. Waters has consulting privileges at Oak Hill. In addition to consulting there, Dr. Waters presents medical education programs at Oak Hill. Forty to 50 percent of Dr. Waters' patients come from Hernando County and Oak Hill Hospital. Dr. Waters and his group strongly support initiation of an open heart surgery ("OHS") program at Oak Hill. Their support is based, in part, on the excellence of the institution, including its physical structure, cath labs, intensive care units, nursing staff, medical staff, and the state of its cardiology program. Dr. Waters and his group are prepared to assist in the development of an open heart surgery program at Oak Hill, and to assure appropriate surgery coverage. Oak Hill will create a Heart Center at the hospital to house its OHS program. All diagnostic and invasive cardiac services will be located in one area of the hospital to ensure efficient patient flow and access to support services. The center will occupy existing space to be renovated and newly constructed space on the first floor of the facility. Two new cardiovascular surgery suites, with all support spaces necessary, will be constructed, along with an eight-bed cardiovascular intensive care unit. The hospital's two state- of-the-art cardiac catheterization laboratory suites are available for diagnostic procedures and angioplasty procedures. A large waiting area and cardiac education/therapy room will also be constructed. Open heart surgery patients will progress from the OR to the new CVICU for the first 24-28 hours after surgery. From the CVICU, the patient will be admitted to a thirty-bed telemetry monitored progressive care unit, located on the second floor. Currently a 38-bed medical/surgical unit, thirty of the beds will remain as PCU beds. Eight beds will be relocated to create the CVICU. The PCU will provide continued care, education and discharge planning for post open heart surgery and angioplasty patients. Oak Hill will also implement a comprehensive cardiac rehabilitation program for both inpatients and outpatients. Brooksville Regional Like Oak Hill, part of the purpose of the Brooksville Regional proposal is to provide more convenient OHS and angioplasty services to Hernando County residents in need of them, 94 percent of whom now travel to Bayonet Point in Pasco County for such services. In addition to proposing improvements in patient convenience and access, Brooksville Regional sees its application as increasing patient choice and competition in the delivery of the services. Indeed, patient choice and competition for the benefit of patients, physicians and payers of hospital services are the cornerstone of Brooksville Regional's application. There is support for the proposed program from the community and from physicians. For example, Dr. Jose Augustine, a cardiologist and Chief of the Medical Staff at Oak Hill since 1997, wrote a letter of support for an open heart program at Brooksville Regional. Although he believes Hernando County would be better served by a program at Oak Hill, he wrote the letter for Brooksville Regional because, "if Oak Hill didn't get it, [he] wanted the program to be here in Hernando County." (Oak Hill No. 12, p. 43.) Consistent with his position, Dr. Augustine finds Brooksville Regional to be an appropriate facility in which to locate an open heart program and he would do all he could to support such a program including providing support from his cardiology group and encouraging support other physicians. But Brooksville Regional offered no evidence regarding the identity of its cardiovascular surgeons. Hernando HMA proposes to construct a state-of-the-art building of 19,500 square feet at Brooksville Regional to house its OHS program. Two OHS operating rooms will be built. Eight CVICU beds will be used for the program, to be converted from other licensed beds. A second cath lab will be added. The total project cost is nearly $12 million. Brooksville Regional proposes to serve all of Hernando County. In addition, 10 percent of its volume is expected to come from Citrus County. Brooksville Regional commits to serving all payer groups with the vast majority projected to be Medicare, Medicare HMO/PPO and non-Medicare managed care. Brooksville lists two specific CON conditions in its application. First, it commits to over 2 percent for charity care and 1.6 percent for Medicaid. Second, it commits to establishing the OHS program at Brooksville's existing facility, located at 55 Ponce de Leon Boulevard in the City of Brooksville. The second of these two was reaffirmed unequivocally at hearing when Brooksville introduced testimony that if Brooksville's CON application is approved, its OHS program will be located at Brooksville's existing facility. Need In Common One "not normal" circumstance exist that supports all three applications: the lack of effect any approval will have on the sub-350 performers in the district. Which, if any, of the three applicants should be awarded an adult open heart surgery program, therefore, is determined on the basis of need and that determination is to be made in the context of comparative review. Benefits of Increased Blood Flow Lack of blood flow to the heart caused by narrowed arteries or blood clots during a heart attack, results in a loss heart of muscle. The longer the blood flow is disrupted or diminished, the more heart muscle is lost. The more heart muscle lost, the more likely the patient will either die or, should the patient survive, suffer a severe reduction in the quality of life. The key to prevent the loss of heart muscle in a heart attack is to restore blood flow to the heart through a process of revascularization as quickly as possible. Cardiovascular surgeons and cardiologists make reference to this phenomenon through the maxim, "time is muscle." The faster revascularization is accomplished the better the outcome for the patient. Those who treat heart attack patients seek to restore blood flow within a half hour of the onset of the attack. Revascularization within such a time frame maximizes the chance of reducing permanent damage to the heart muscle from which the patient cannot recover. Achievement of revascularization between 30 minutes and 90 minutes of the attack results in some damage. Beyond 90 minutes, significant permanent damage resulting in death or severe reduction in quality of life is likely. The three primary treatment modalities available to a patient suffering from a heart attack are: 1) thrombolytics; 2) angioplasty and 3) open heart surgery. Thrombolytic therapy is the standard of care for the initial attempt to treat a heart attack. Thrombolytic therapy is the administration of medication, typically tissue plasminogen ("TPA") to dissolve blood clots. Administered intravenously, the thrombolytic begins working within minutes in an attempt to dissolve the clot causing the heart attack and, therefore, to prevent or halt damage to the heart muscle. Thrombolytic therapies are successful in restoring blood flow to the affected heart muscle about 60 to 75 percent of the time. In the event it is not successful or the patient is not appropriate for the therapy, the patient is usually referred for primary angioplasty, a therapeutic cardiac catheterization procedure. Cardiac catheterization is a medical procedure requiring the passage of a catheter into one or more cardiac chambers with or without coronary arteriograms, for the purpose of diagnosing congenital or acquired cardiovascular diseases, and includes the injection of contrast medium into the coronary arteries to find vessel blockage. See Rule 59C-1.032(2)(a), Florida Administrative Code. Primary angioplasty is defined as a therapeutic cardiac catheterization procedure in which a balloon-tipped catheter inflated at the point of obstruction is used to dilate narrowed segments of coronary arteries in order to restore blood flow to the heart muscle. Rule 59C-1.032(2)(b), Florida Administrative Code. More often now, in the wake of cardiac care advances, a "stent" is also placed in the re-opened artery. A stent is a wire cylinder or a metal mesh-sleeve wrapped around the balloon during an angioplasty procedure. The stent attaches itself to the walls of the blocked artery when the balloon is inflated, acting much like a reinforced conduit through which blood flow is restored. Its advantage over stentless angioplasty is improved blood flow to the heart and a reduction in the likelihood that the artery will collapse in the future. In other words, a stent may prevent substantial re-occlusion. The development of stent technology has led to dramatically increased angioplasty procedure volumes in recent years and the trend is continuing. Based on mortality rates, studies suggest that immediate angioplasty, rather than thrombolytic treatment, is the preferred treatment for revascularization. When thrombolytic therapy is inappropriate or fails and a patient is determined to be not a candidate for angioplasty, the patient is referred for open heart surgery. Under the Open Heart Surgery Rule, Rule 59C-1.032, Florida Administrative Code, a cardiac catheterization program that includes the provision of angioplasty must be located within a hospital that also provides open heart surgery services. Open heart surgery is a necessary backup in the event of complications during the angioplasty. The residents of Citrus Memorial's primary service area (and those of Oak Hill's and Brooksville Regional's), therefore, do not have immediate access (that is access to a hospital in their county of residence) to not just open heart surgery services but to angioplasty services as well. In addition to increased benefits to the residents of the proposed service areas, much of the need in this case is based on a demonstration of geographic access problems. For example, population concentration and historical utilization of open heart surgery services in the district demonstrate that the open heart surgery programs in the district are maldistributed. At the same time, the Bayonet Point program's service by virtue of both superior quality and proximity to Hernando County ameliorates the effect of the maldistribution of the programs intra-district particularly with regard to the residents of Hernando County. The four southernmost of the 16 counties in the district (Citrus, Hernando, Sumter and Lake) account for approximately 41 percent of the total adult population and 53.5 percent of the population aged 65 and over within District 3 as a whole. The super majority of aged 65 and over population in these counties is of great significance since that population is the primary base of those in need of adult open heart surgery and angioplasty. This same base accounts for 57 percent of the total annual open heart surgeries performed on district residents. For District 3 as a whole, 27 percent of the adult population is aged 65 and older. In comparison, 38.2 percent of Citrus County residents fall within that age cohort, 37.2 percent of Hernando County residents and 33.3 percent of residents in Lake and Sumter Counties combined fall within that age cohort. In contrast, in the northern part of the district, the counties closest to the three Gainesville open heart surgery programs (Columbia, Hamilton, Suwanee, Alachua, Bradford, Dixie, Gilchrist, Lafayette, Levy, and Union) contain a combined basis of 32.4 percent and Putnam County contains 24.7 percent of the District 3 population aged 65 and over. The overall District 3 open heart surgery use rate (number of surgeries per 1,000 population age 15 and over) is 3.47. Yet, the combined use rate for Columbia, Hamilton, and Suwanee Counties is 1.96, the combined use rate for Alachua, Bradford, Dixie, Gilchrist, Lafayette, Levy, and Union Counties is 1.55, and the Putnam County use rate is 2.05. More specifically, the northern county use rates are significantly below the use rates for the remainder of District 3 counties. Marion County is 4.12. Citrus County is at 4.26. Hernando County is at 6.41. Lake and Sumter Counties are at 4.31. Transfers Drive time is but one component of the total time necessary to effectuate a patient transfer. Additional time is consumed in making transfer and admission arrangements with the receiving hospital, awaiting arrival of an ambulance to begin transport, and preparing and transferring the patient into and out of the ambulance. Time delays that necessarily accompany hospital-to-hospital transfers can be critical, clinically. The fact that a facility-to-facility transfer is required means that the patient is at relatively high risk. Otherwise, the patient would be sent home and electively scheduled later. The need to travel outside the community carries other adverse consequences for patients and their families. Continuity of care is disrupted when patients cannot receive hospital visits from their regular and trusted physicians. Separation from these physicians increases stress and anxiety for many patients, and patients heal better with lower levels of stress and anxiety. Further, most OHS patients are elderly, and travel by their spouses to another community to visit is stressful and difficult at best, sometimes impossible. The elderly loved ones of the patient also tend to have health problems and, even when able, the drive to the hospital is stressful. District 3 Out-migration A high volume of OHS patients leave District 3 for OHS services. During the year ended March 1999, there were a total of 3,520 District 3 residents discharged from Florida hospitals following OHS. Only 2,428 of those OHS cases were reported by hospitals located within District 3. An outmigration rate of 31 percent, on its face, is indicative of a district geographic access problem. The problem is mitigated, however, by an understanding that most of the outmigration is of Hernando County residents who are able to travel or are transferred to Bayonet Point, a provider within 30 to 45 minutes driving time from the two Hernando County applicants in this proceeding. Citrus Memorial Volume Projections and Financial Feasibility Citrus Memorial reasonably projects an open heart surgery case volume of 266 for the first year of operation, 313 for the second year, and 361 for the third year. Citrus Memorial reasonably projects an angioplasty case volume of 409 for the first year of operation, 481 for the second year, and 554 for the third year. The Citrus Memorial program is financially feasible in the long term. It will generate approximately $1 million in not-for-profit income by the end of the second year of operation ($327,609 from open heart surgery cases, and $651,323 from angioplasty cases). Increased Access in Citrus County The two Ocala hospitals are approximately 30 miles from Citrus Memorial. With traffic, the normal driving time from Citrus Memorial to the hospitals is 60 minutes. The driving time from Oak Hill to Bayonet Point is normally 29 minutes or about half the time it takes to get from Citrus Memorial to one of the Ocala providers. The drive time from Brooksville Regional to Bayonet Point is approximately 45 minutes, 25 percent faster than the driving time from Citrus Memorial to the Ocala hospitals. Myocardial infarction patients for whom thrombolytic therapy is inappropriate or ineffective who present to the emergency room at Citrus Memorial, on average, therefore, are exposed to greater risk of significant heart muscle damage than those who present to the emergency rooms at either Oak Hill or Brooksville Regional. The delay in transfer for a Citrus Memorial patient in need of angioplasty or open heart surgery can be compounded by the ambulance system in Citrus County. There are only 7 ambulances in the system. If one is out of the county, the provider of ambulance services will not allow another to leave the county until the first has returned. Citrus Memorial presented medical records of 17 cases in which transfers took more than an hour and in some cases more than 3 hours from when arrangements for transfers were first made. There was no testimony to explain the meaning of the records. Despite the status of the records as admissible under exceptions to the hearsay rule and therefore the ability to rely on them for the truth of the matters asserted therein, the lack of expert testimony diminishes the value of the records. For example in the first case, the patient presented at the emergency room on June 14, 1999. Treatment reduced the patient's chest pain. In other words, thrombolytics appeared to be beneficial. The patient was admitted to the coronary care unit after a diagnosis of unstable angina, and cardiac catheterization was ordered. On June 15, the next day, at about 11:40 a.m., "just prior to going down to Cath Lab, patient developed severe chest pain." (Citrus Memorial Ex. 16, p. 1017.) Following additional treatment, the chest pains were observed half an hour later to be "better." (Id.) Several hours later, at 1:45 p.m., that day, transfer to Ocala Regional was ordered. (Id., p. 1043). The patient's progress notes show that the transfer took place at 3:45 p.m., two hours after the order for transfer was entered. Whether rapid transfer was required or not is questionable since the patient appears to have been stabilized and had responded to thrombolytics and other therapy. In contrast, the second of the 17 cases is of a patient whose "risk of mortality [was] . . . close to 100%." The physician's notes indicate that at 1:10 p.m. on August 8, 1999, "emergency cardiac cath [was] indicated [with] a view toward revascularization." (Citrus Memorial Ex. 16, p. 1093). The same notes indicate after discussion between the physician and the patient and his spouse "that transfer itself is risky, but that risk of mortality [if he remained at Citrus Memorial] . . . is close to 100 percent." Although these same notes show that at 1:10 p.m., the patient's transfer had been accepted by the provider of open heart surgery, it was not until 3:30 p.m., that the "Ocala team" (id., at 1113) was shown to be present at Citrus Memorial and not until 3:45 p.m., that the patient was "transferred to Ocala." (Id.) Given the maxim that "time is muscle," it may be assumed that the 2-hour and 45- minute delay in transfer from the moment the patient was accepted for transfer until it occurred and the ensuing time thereafter for the drive to Ocala contributed to significant negative health consequences to the patient. Whatever the value of the 17 sets of medical records, they demonstrate that transfers from Citrus Memorial on occasion take up time that is outside the 30-minute and 90-minute timeframes for avoiding significant damage to heart muscle or minimizing such damage to heart attack patients for whom angioplasty or open heart surgery procedures is indicated. Citrus Memorial also presented twenty sets of records from which the "emergent" nature of the need for angioplasty or open heart intervention was more apparent from the face of the records than in the 17 cases. (Compare Citrus Memorial Ex. No. 16 to No. 17). These records reveal transport delays in some cases, lack of immediate bed ability at the Ocala hospitals in others, and in some cases both transport delays and lack of bed availability. In 16 of the cases, it took over 90 minutes for the patient to reach the receiving hospital and in 13 of the cases, it took 2 hours or more. It would be of significant benefit to some of those who present to Citrus Memorial's emergency room with myocardial infarctions to have access to open heart surgery services on site should thrombolytic therapy be inappropriate or prove ineffective. Other Access Factors Besides time considerations, there are other factors that provide comparisons related to access by Citrus Memorial service area residents on the one hand and Hernando County residents to be served by either Oak Hill or Brooksville Regional on the other. Among the other factors relied on by Citrus Memorial to advance its application is a comparison of use rate. The use rate per 1,000 population aged 15 and over for Hernando County is 6.08, compared to 4.13 for Citrus County. "[B]y definition" (tr. 458), the use rates show need in Hernando County greater than in Citrus County. But the use rates could indicate an access problem financially or geographically. In the end, there are a lot of components that make up the use rate. One is obviously the age of the population and underlying heart disease, two, . . . is the physician practice patterns in the county. [S]tudies . . . show that [in] two equivalent populations, . . . one with a very conservative medical community that . . . hospitalizes more frequently . . . [versus] another . . . where the physicians hospitalize less frequently for the same situation or who use a medical approach versus a surgical approach. (Id.) While there may be one possible explanation for the lower use rate in Citrus County than in Hernando County that favors Citrus Memorial, a comparison of use rates on the state of this record is not in Citrus Memorial's favor. Other factors favor Citrus Memorial. In support of its open heart surgery and angioplasty volumes, for example, Citrus Memorial reasonably projects an 80 percent market share for such services from its primary service areas. In contrast, Oak Hill projected a much lower market share from its primary service area: 58 percent. The lower market share projection by Oak Hill is due to the proximity of the Bayonet Point program to Hernando County. The difference in the two projections reveals greater demand for improved access in Citrus County than in Hernando County. This same point is revealed by projected county outmigration. Statewide data reveals that the introduction of open heart surgery services within a county causes a county resident generally to stay in the county for those services. Yet with a new program in Hernando County, Bayonet Point is still projected reasonably to capture one-half of the open heart surgeries and angioplasties performed on Hernando County residents, further support for the notion that Hernando County residents have adequate access to open heart surgery services through Bayonet Point's program. As to angioplasty demand, Oak Hill projected an angioplasty/open heart surgery ratio of 1.3. Citrus Memorial's ratio is 1.5. Geographic access limitations also adversely affect continuity of care. To have open heart surgery performed at another hospital, the patient will have to travel for pre- operative, operative, and post-operative follow-up services and duplication of tests. This lack of continuity of care often results in the patient's primary and specialty care physicians not following the patient and not being involved with all phases of care. In assessing travel time and access issues for open heart surgery and angioplasty services, travel time and distance present not only potential hardship to the patient, but also to the patient's family and friends who accompany and visit the patient. These issues are of particular significance to elderly persons (be they the patient, family member or friend) who do not drive and must rely on others for transport. Financial Access - Indigent Care Consistent with its mission as a community not-for- profit hospital, Citrus Memorial will accept any patient who comes to the hospital regardless of ability to pay. In 1999, Citrus Memorial provided approximately $4.9 million in charity care, representing 3.6 percent of its gross revenues. Citrus County provided Citrus Memorial with $1.2 million dollars in subsidization, part of which was allotted to capital construction and maintenance, part of which was allotted to charity care. Subtracting all $1.2 million, as if all had been earmarked for charity care, from the charity care, the dollar amount of Citrus Memorial's out-of-pocket charity care substantially exceeds the dollars for the same period provided by Oak Hill ($1.3 million) and by Brooksville Regional ($935,000). The percentage of gross revenue devoted to charity care is also highest for Citrus Memorial; Brooksville Regional's is 1.1 percent and tellingly, Oak Hill's, at 0.6 percent is less than one-quarter of Citrus Memorial's percentage of out-of- pocket charity care. "[C]learly Citrus has a much stronger charity care credential than does either Oak Hill or Brooksville Regional." (Tr. 241). But this credential does not carry over into the open heart surgery arena. As a condition to its CON, Citrus Memorial committed to a minimum 2.0 percent of total open heart surgery patient days to Medicaid/charity patients. The difference between Citrus Memorial's commitment and that of Oak Hill's and Brooksville Regional's, both standing at 1.5 percent, is not nearly as dramatic as past performance in charity care for all services. The difference in the comparison of Citrus Memorial to the other applicants between past overall charity care and commitment to future open heart services for Medicaid and charity care is explained by the population that receives open heart and angioplasty services. That population is dominated by those over 65 who are covered by Medicare. Competition Citrus Memorial's current charges for cardiology services are significantly lower than comparable charges at Oak Hill or Brooksville Regional. A comparison of the eight cardiology-related DRGs that typically have high volume utilization reveals that Oak Hill's gross charges are 62 percent greater than Citrus Memorial's gross charges. A comparison of gross charges is not of great value, however, even though there are some payers that pay billed charges such as "self-pay" and indemnity insurance. When managed care payments are a function of gross charges then such a comparison is of more value. On a net revenue per case basis for those DRGs, Oak Hill's net revenues are 10 percent greater than Citrus Memorial's. A 10 percent difference in net revenues, a much narrower difference than the difference in gross charges, is significant. Furthermore, it is not surprising to see such a narrowing since most of the utilization is covered by Medicare which makes a fixed payment to the provider. A comparison of projections in the applications reveals that Oak Hill's gross revenue per open heart surgery cases will be 164 percent greater than Citrus Memorial's gross revenue per such case. Oak Hill's net revenue per open heart surgery case will be 32 percent greater than Citrus Memorial's net revenue per such case. A comparison of projections in the applications also reveals that Oak Hill's gross revenue per angioplasty case will be 74 percent greater than Citrus Memorial's and that Oak Hill's net revenues per angioplasty case will be 13 percent greater than Citrus Memorial's. If a program is established at Oak Hill, there will be a hospital within District 3 with a new open heart surgery program. But what Oak Hill, under the umbrellas of HCA, proposes to do in reality is to take a quarter of the volume from [Bayonet Point, a] premier facility to set up in a sense a satellite operation at a facility . . . 16 miles away . . . [when] those patients already have an established practice of going to the premier tertiary facility . . . [ and when the two enjoy] a very strong positive relationship. (Tr. 1434). Such an arrangement will do little to nothing to enhance competition. Comparing Citrus Memorial and Brooksville Regional gross revenues on the basis of the same cardiology-related DRGs reveals that Brooksville's gross charges are 83 percent greater than Citrus Memorial's charges. A comparison of projections in the applications reveals that Brooksville Regional's gross revenue per open heart surgery case will be 147 percent greater than Citrus Memorial's and the Brooksville's net revenue per open heart surgery case will be 45 percent greater than Citrus Memorial's. A comparison of projections in the applications reveals that Brooksville's gross revenue per angioplasty case will be 36 percent greater than Citrus Memorial's and that Brooksville's net revenue per angioplasty case will be 7 percent lower than Citrus Memorial's. Impact of a Citrus Memorial Program on Existing Providers Citrus Memorial reasonably projected that by the third year of operation, a Citrus Memorial program will take away 100 cases from Ocala Regional. In 1999 Ocala Regional had an open heart surgery volume of 401 cases. In 2000, its annual volume was 18 cases more, 419. This is a decline from both the immediately prior two-year period, 1997 to 1998 and the two-year period before that of 1995 to 1996. The volume decline for the two-year period 1999 to 2000 compared to the previous two-year period, 1997 to 1998 is not at all surprising because of "two big factors." (Tr. 97). First, in 1997 and 1998, Ocala Regional was used as a training site for the development of Leesburg Regional's open heart surgery program that opened in December of 1998. In essence, Ocala Regional enjoyed an increase in the volume of cases in 1997 and 1998 when compared to previous years and a spike in volume when compared to both previous and subsequent two-year periods because of the 1997-98 short-term "windfall.) (Id.) Second, Ocala Regional was a Columbia-owned facility. In 1999 and thereafter, "Columbia developed a lot of bad publicity because of some federal investigations that were going on of the Columbia system." (Id.) The publicity negatively affected the hospital's open heart surgery volume in 1999 and 2000. The second factor also helps to explain why Ocala Regional's volume in 1999 and 2000 was lower than in 1995 and 1996. There are other factors, as well, that help explain the lower volume in 1999 and 2000 than in 1995 and 1996. In any event if impact to Ocala Regional, alone, were to be considered for purposes of the prohibition in Rule 59C- 1.033(7)(c), that a new program will not normally be approved if approval would reduce 12-month volume at an existing program below 350, then the impact might result in veto by rule of approval of a program at Citrus Memorial. But Ocala Regional is but one hospital under a single certificate of need shared with another hospital across the street from its facility: Munroe Regional. Annualization for 1999 of discharge data for the 12 months ending September 30, 1999 shows that Munroe Regional enjoyed a volume of 770 cases. There is no danger that the program carried out by Ocala Regional and Munroe Regional jointly under a single certificate of need will fall below 350 procedures annually should Citrus Memorial be approved. Oak Hill Need for Rapid Interventional Therapies and Transfers A high number of residents of Oak Hill's proposed service area present to its emergency room with myocardial infarctions. Many of them would benefit from prompt interventional therapies currently made available to them at Bayonet Point. Over 600 patients annually, almost two patients every day, must be transferred by ambulance from Oak Hill to Bayonet Point for cardiac care. A significant number of them would benefit from interventional therapy more rapidly available. The travel time from Oak Hill to Bayonet Point is the least amount of time, however, of the travel time from any of the three applicants in this proceeding to the nearest existing open heart provider; Brooksville Regional to Bayonet Point or Citrus Memorial to one of the Ocala providers. The extent of the benefit, therefore, is difficult to quantify and is, most likely, minimal. As with the other two applicants, thrombolytic therapy is the only method of revascularization currently available to Oak Hill's patients because Oak Hill is precluded by Agency rule and clinical standards from offering angioplasty without on-site open heart surgery backup. The percentage of MI patients who are ineligible for thrombolytic therapy, coupled with the percentages of patients for whom thrombolytic therapy is ineffective, are extremely significant given the high number of MI patients presenting to Oak Hill's emergency room. During 1998, 418 patients presented to Oak Hill's ER with an MI, and 376 MI patients presented in 1999. During the first eight months of 2000, 255 MI patients presented to Oak Hill's ER, an annualized rate of 384. Conservatively, thrombolytic therapy is not effective for at least 10 percent of patients suffering from an acute MI, either because patients are ineligible to receive the treatment or the treatment fails to clear the blockage. Accordingly, it may be conservatively projected that at least 104 patients who presented to Oak Hill's ER between 1998 and August 2000 (10 percent of 1049) suffering an MI were in need of angioplasty intervention for which open heart surgery backup is required. Most patients are diagnosed as in need of OHS or angioplasty as a result of undergoing a diagnostic cardiac catheterization. Oak Hill performs an extremely high volume of cardiac cath procedures for a hospital that lacks an OHS program. In 1999, for example, it performed 1,641 cardiac catheterizations. This is a higher volume than experienced by any of six hospitals during the year prior to which they recently implemented new OHS programs. If Oak Hill had an OHS program, most of the patients at Oak Hill determined to be in need of angioplasty or OHS could receive those procedures at Oak Hill. Such an arrangement would avoid the inevitable delay and stress occasioned by a transfer to Bayonet Point or elsewhere. Furthermore, if Oak Hill had an OHS program then those patients in need of diagnostic cardiac catheterization and angioplasty sequentially would have immediate access to the interventional procedure. The need is underscored for those patients presenting to Oak Hill's ER with myocardical infarctions who do not respond to thrombolytics because, as stated earlier in this order, access to angioplasty within 30 minutes of onset is ideal. Oak Hill transfers an extremely high number of cardiac patients for angioplasty and open heart surgery. In 1999, Oak Hill transferred 258 patients to Bayonet Point for open heart surgery, and 311 for angioplasty/stent procedures. Of course, most OHS patients are scheduled on an elective basis for surgery, rather than being transferred between hospitals, as is evident from the fact that during the 12-month period ending March 1999, 698 Hernando County residents underwent OHS. For now, Oak Hill patients determined to be in need of urgent angioplasty or open heart surgery must be transferred by ambulance to an OHS provider which for the vast majority of patients is Bayonet Point. Approximately 17 miles south, the average drive time to Bayonet Point from Oak Hill is 30 minutes but it can take longer when on occasion there is traffic congestion. Once the transfer is achieved and patient receives the required procedure, the drive can be difficult for the patient's family and loved ones. Community members often express to physicians and hospital staff their support and desire for an OHS program at Oak Hill. Many believe travel outside Hernando County for those services is cumbersome for loved ones who are important to the patient's healing process. The community support and demand for these services is evidenced by the 7,628 resident signatures on petitions in support of Oak Hill's efforts to obtain approval for an OHS program. While a program at Oak Hill would be more convenient, Oak Hill did not demonstrate a transfer problem that would rise to the level of "not normal" circumstances. Because of Oak Hill's relationship with Bayonet Point, Bayonet Point's proximity and excess capacity, coupled with the high quality of the program at Bayonet Point, Oak Hill's case is more in the nature of seeking a satellite. As one expert put it at hearing, [Oak Hill] is, in fact, a satellite. And my question is, [']What's the wisdom of doing that if you don't have the problems that normally are being addressed when you grant approval of a program?['] In other words, if you don't have transfer issues [that rise to the level of "not normal" circumstances], if you don't have access issues, if you're not achieving any price competition, if it's not particularly cost effective, why would you [approve Oak Hill]? (Tr. 1537-38). Oak Hill's Projected Utilization Oak Hill projected a range of 316 to 348 OHS cases during its first year, and by its third year a range of between 333 and 366 cases. Those volumes are sufficient to ensure excellent quality of care from the beginning of the program, particularly with the involvement of the Bayonet Point surgeons. Oak Hill defined its primary service area (PSA) for OHS based on historic MDC-5 cardiology related diagnosis discharges from its hospital. For the 12-month period ended March 1999, over 90 percent of Oak Hill's MDC-5 discharges were residents of six zip codes, all in the vicinity of Oak Hill Hospital and within Hernando County. Accordingly, that area was chosen as the PSA for projecting OHS utilization. Out-of-PSA residents accounted for only 8.9 percent of Oak Hill's MDC-5 discharges, and of these, 1.5 percent were out-of-state patients, and 4.9 percent were residents from other parts of District 3. For the year ending ("YE") March 1999, Oak Hill had an MDC-5 market share of 40.9 percent within its PSA, without excluding angioplasty, stent, and OHS cases. If angioplasty, stent, and OHS cases are excluded, Oak Hill's PSA market share was 52.7 percent. In order to project OHS service demand, Oak Hill examined the population projections for 1999 and 2004 for District 3, and for Oak Hill's PSA. The analysis was based on age-specific resident populations and use rates, to serve as a contrast to the Agency's projections. The numeric need formula in the OHS Rule utilizes a facility based use rate derived by totaling all of the reported OHS cases performed by hospitals within a District during a given time period, and then dividing those cases by the adult population aged 15 and over. While a facility-based use rate measures utilization in those District hospitals, however, it does not measure out-migration. Nor does it reflect the residence of the patients receiving those services. On the other hand, a resident-based use rate identifies where patients needing OHS actually come from, and permits development of age specific use rates. For example, the resident-based use rates reflects that the southern portion of District 3 has a much higher concentration of elderly persons than does the northern portion of the District, and reveals extremely high migration out of the District for OHS services. Oak Hill's PSA is more elderly than the District 3 population as a whole. In 1999, 32.8 percent of the Oak Hill PSA population was aged 65 or over, as opposed to only 21.5 percent for District 3 as a whole, with similar results projected for the population in 2004, the projected third year of operation of Oak Hill's program. Based on the district-wide use rate resulting from the OHS Rule need methodology, Hernando County would be expected to generate 276 OHS cases in the planning horizon of July 2002 (use rate of 2.3 per 1000 adult population). Application of this OHS Rule use rate to Hernando County clearly understates need if resources to meet the need are considered within the isolation of the boundaries of District 3. For example, the OHS Rule based projection of 276 OHS cases in 2002, is far below the actual 664 Hernando County resident OHS discharges during YE March 1998, and the 698 OHS cases during YE March 1999. While the facility-based district-wide use rate was 2.3, the Hernando County resident-based use rate was 6.45 per 1000 population. The fact of increasing use rates with age is demonstrated by the Hernando County resident use rate of 6.95 for ages 55-64, increasing to 12.01 for ages 65-74, and increasing again to 14.95 for age 75 and over. But focusing on Hernando County use rates within District 3 ignores the reality of the proximity of an excellent program at Bayonet Point. Oak Hill reasonably projected OHS demand in its PSA by examining the age-specific use rates of residents in the southern portion of District 3, which experienced an overall use rate of 4.55 for the year ending March 1999. Those age-specific use rates were then applied to the age-specific population forecast for each of the three horizon years of 2002 through 2004, resulting in an expected PSA demand for OHS of 547 cases in 2002, 561 cases in 2003, and 575 cases in 2004. Those projections are conservative given that 663 actual open heart surgeries were reported among PSA residents during the YE March 1999. The same methodology was used to project angioplasty service demand in the PSA, resulting in an expected demand ranging from 721 cases in 2002 to 758 cases in 2004. Oak Hill then projected its expected OHS case volume by assuming that its first year OHS market share within its PSA would be the same as its MDC-5 market share, being 52.7 percent. Oak Hill next assumed that by the third-year operation its market share would increase to equal its current cardiac cath PSA market share of 57.9 percent. It further assumed that it would have a non-PSA draw of 8.9 percent, which is equal to its current non-PSA MDC-5 market share. Oak Hill reasonably expects that 91.1 percent of its OHS cases would come from within its six zip code PSA, with the remaining 8.9 percent expected to come from outside that area. Oak Hill then projected an expected range of OHS discharges during its first three years of operation by using both a low estimate and a high estimate. The resulting utilization projections reflect a low range of 316 OHS cases in 2002, 324 cases in 2003, and 333 cases in 2004. The high range estimate for the same years respectively would be: 348, 357, and 366 cases. The same methodology was used to project angioplasty cases, resulting in the following low range: 417 cases in 2002; 428 in 2003; and 438 in 2004. The expected high range for the same respective years would be: 458, 470, and 482. Oak Hill's OHS and angioplasty utilization projections are reasonable. Long-term Financial Feasibility Long-term financial feasibility is defined as a demonstration that the project will achieve and maintain financial self-sufficiency over time. Oak Hill's projected gross charges were based on Bayonet Point's charge structure. The projected payer mix was based on Oak Hill's cardiac cath experience. Projected net reimbursement by payor source was based on Oak Hill's experience for Medicare, Medicaid, and contractual adjustment history. Oak Hill's expenses were projected on a DRG specific basis using information generated by the cost accounting system at Bayonet Point. The use of Bayonet Point's expense experience is a reasonable proxy for a number of reasons. Its patient base is comprised of patients who are reasonably expected to be the base of Oak Hill's patients. Management there is similar to what it will be at an Oak Hill program. And, as stated so often, the two facilities are relatively close in location. To account for differences between Bayonet Point's expenses and Oak Hill's project costs, interest and depreciation, adjustments were made by Oak Hill as reflected in its application. As a means of compensating for fixed costs differentials between the two hospitals, Oak Hill added its salary costs projected in Schedule 6 to the salary expenses already included in Bayonet Point's costs. (Schedule 6 nursing, administration, housekeeping, and ancillary labor costs exceeded $3 million in the first year of operations.) This counting of two sets of salary expenses offsets any economies of scale cost differential that may exist between the OHS programs at Bayonet Point and Oak Hill. A reasonable 3 percent annual inflation factor was applied to both projected charges and costs. The reasonableness of Oak Hill's overall approach is supported by Citrus Memorial's use of a substantially similar pro forma methodology in modeling its proposed program on Munroe Regional Medical Center. Oak Hill reasonably projects a profit of $1.38 million in the first year of operation, and that profitability will increase as the case volumes grow thereafter. An Oak Hill program will cost Bayonet Point (a sister HCA hospital) patients and may diminish the corporate profits of the two hospital's parent corporation, HCA Health Services of Florida, Inc. It is clear from the parent's most recent audited financial statements, however, that it has ability to absorb a lower level of profit from Bayonet Point without jeopardizing the financial viability of Oak Hill. Brooksville Regional argues that the financial impact to Bayonet Point of an Oak Hill program demonstrates that the Oak Hill application is nothing more than a preemptive move to stifle competition. Oak Hill, in turn, characterizes its proposal as a sound business judgement to compete with non-HCA hospitals in District 3. Whatever characterization is applied to the Oak Hill proposal, it is clear that it is financially feasible in the long term. Other Statistics The AHCA population estimates for January 1, 1999, show a Hernando County population of 108,687 and a Citrus County population of 98,912. The same data sources show the "age 65 and over" population (the "elderly") in Hernando to be 40,440 and in Citrus to be 37,822. During the year 2000, there were 2,545 more people aged 65 and over in Hernando County than in Citrus County. By the year 2005, the difference is expected to be 3.005. The total change in the elderly population between 2000 and 2005 is projected to be 4,109 in Citrus County and 4,614 in Hernando County. Generally, the older the population, the older the OHS use rate. Comparatively, then, Hernando County has the larger population to be served both now, and in all probability, in the foreseeable future. Oak Hill has the largest cardiology program among the applicants. For the 12-month period ending September 1999, MDC- 5 discharges were 1,130 at Brooksville Regional, 2,077 at Citrus Memorial and 2,812 at Oak Hill. The combined Brooksville and Spring Hill Regional Hospital MDC-5 case volume of 2,238 is below Oak Hill's MDC case volume for the same period. Oak Hill is the largest cardiac cath provider among the applicants. For the 12-month period ending September 2000, Citrus Memorial reported 646 cardiac catheterization procedures and Brooksville Regional reported 812. Oak Hill reported 1,404 such procedures, only sixty shy of a volume double the combined volume at the other two applicants. The level of ischemic heart disease in an area is indicative of the level of open heart surgery needed by residents of the area. The number of ischemic heart disease cases by county during the 12-month period ending September 1999 were: 1,038 for Alachua; 1,978 for Citrus; 2,816 for Marion; and, Hernando, 3,336. During the 12-month period ending September 1999, 657 Hernando County residents underwent OHS at Florida hospitals, while only 408 residents of Citrus County did so. Similarly, 948 Hernando County residents had angioplasty, while only 617 Citrus County residents underwent angioplasty. For the year ending June 30, 1999, the Citrus County OHS use rate was 4.26 per 1,000 population, substantially lower than the Hernando County use rate of 6.41. A comparison of the use rates for the year ending September 30, 1999, again shows Hernando County's use rate to be higher: 4.13 for Citrus, 6.08 for Hernando. Hernando County also experiences a higher cardiovascular mortality rate than does Citrus County. During 1998, the age-adjusted cardiovascular mortality rate per 100,000 population for Citrus was 330.88 and 347.40 for Hernando. During 1999, those mortality rates were 304.64 in Citrus and 313.35 in Hernando (consistent with the decline between 1998 and 1999 for the state as a whole). The Hernando mortality rates greater than Citrus County's indicate a greater prevalence of heart disease in Hernando County than in Citrus County. Most importantly, during 1999, Oak Hill transferred 619 patients to Bayonet Point for cardiac intervention - 258 for open heart surgery, 311 for angioplasty/stent, and 50 for cardiac cath. Brooksville Regional transferred a combined 383 patients after diagnostic cardiac catheterization to other hospitals for either angioplasty or OHS. Brooksville Regional has 91 licensed beds, Citrus Memorial has 171 beds and Oak Hill has 204 beds. Although with Spring Hill one could view Brooksville Regional as "two hospital systems with 166 beds under common ownership and control" (Tr. 1544), at 91 beds, Brooksville would become the smallest OHS program in the state in terms of licensed bed capacity, Hospitals of less than 100 beds are not typically of a size to accommodate an OHS program. There might be dedicated cardiovascular hospitals of 100 beds or less with capability to support an open heart surgery program, but "open heart surgical services in [a general, surgical-medical hospital of less than beds] would overwhelm the hospital as far as the utilization of services." (Tr. 126). Oak Hill's physical plant, hospital size, number of beds, medical staff size, number of cardiologists, cath lab capacity, number of cath procedures, number of admissions, and facility accessibility to the largest local population are all factors in its favor vis-à-vis Brooksville Regional. In sum, Oak Hill is a hospital more ready and appropriate for an adult open heart surgery program than Brooksville. Alternatives As an alternative to its CON application, Oak Hill considered the possibility of seeking approval of a program to be shared with Bayonet Point. Learning that the Agency looks with disfavor on inter-district shared adult open heart surgery programs, Oak Hill decided to seek approval of a program independent of Bayonet Point but one that would rely on Bayonet Point's experience and expertise for development, implementation and operation. Bed Capacity Brooksville contends that Oak Hill lacks sufficient bed capacity to accommodate the implementation of an OHS program in conjunction with its projected-related increased admissions. Brooksville relied on an Oak Hill daily census document, focusing on the single month of January, arguing that the document reflected that Oak Hill exceeded its licensed bed capacity on 5 days that month. The licensed bed capacity, however, was not exceeded. Observation patients, who are not inpatients, and not properly included in the inpatient count, were included in the counts provided by Brooksville. Seasonal peaks in census during the winter months, particularly January, are common to all area hospitals. Similarly, all hospitals experience a higher census from Monday through Thursday, than on other days. Oak Hill has adequate capacity and flexibility to accommodate those rare occasional days during the year when the number of patients approaches its number of beds. Patients are sometimes hospitalized for "observation," and when so classified are expected to stay less than 24 hours. Typically, Oak Hill places such patients in a regular "licensed" bed, so long as such beds are available. There are other areas in the hospital suitable for observation patients, including: 12 currently unused and unlicensed beds adjacent to the cardiac cath recovery area; six beds in the ER holding area; eight beds in the ER Quick Care Unit; and additional beds in the same day surgery recovery area. Observation patients can be cared for appropriately in these other areas, a routine hospital practice. Peak season census is "a fact of life" for hospitals, including Oak Hill and Brooksville. Oak Hill has never been unable to treat patients due to peak season demands. January is the only month during the year when bed capacity presents a challenge at Oak Hill. If necessary, Oak Hill could coordinate patient admissions with Bayonet Point to ensure that all patients are appropriately accommodated. Oak Hill can successfully implement a quality OHS program with its current bed capacity. In fact, all parties have stipulated to Oak Hill's ability to do so. Moreover, should it actually come to pass in future years that Oak Hill's annual average occupancy exceeds 80 percent, it may add up to 20 licensed beds on a CON exempt basis. Brooksville Regional Factors favoring Brooksville over Oak Hill Bayonet Point is the dominant provider of OHS/angioplast to residents of Hernando County. As a non-HCA hospital, a Brooksville program (in contrast to one at Oak Hill) would enhance patient choice in Hernando County for hospitals and physicians, and would create an environment for price and managed care competition. Other health planning factors that support Brooksville Regional over Oak Hill are the locations of the two Hernando County hospitals and the ability of the two to transfer patients to Bayonet Point. Patient Choice and Competition Of the OHS/angioplasty services provided to Hernando County residents, Bayonet Point provides 94 percent, the highest county market share of any hospital that provides OHS services to residents of District 3. Indeed, it is the highest market share provided by any OHS provider in any one county in the state. The importance of patient choice and managed care competition has been acknowledged by all the parties to this proceeding. If Brooksville Regional's program were approved, Hernando County residents would have choice of access to a non- HCA hospital for open heart and angioplasty services and to physicians and surgeons other than those who practice at Bayonet Point. This would not be the case if Oak Hill's program was approved instead of Brooksville's. Price Competition Although Brooksville is not a "low-charge provider for cardiovascular services" (tr. 1347), approving Brooksville creates an environment and potential for price competition. A dominant provider in a marketplace has substantial power to control prices. Adding a new provider creates the motivation, if not the necessity, for that dominant provider to begin pricing competitively. A dominant provider controls prices more than hospitals in a competitive market. Bayonet Point's OHS charges illustrate this. Approving Brooksville's application creates an environment for potential price competition with Bayonet Point, whereas approving Oak Hill's application, whose charges are expected to be the same as Bayonet Point's, does not. Managed Care Contracting Just as competitive effects on pricing are reduced in an environment in which there is a dominant provider, so managed care contracting is also affected. Managed care competition depends not just on competition between managed care companies but also on payer alternative within a market. If a managed care company is forced to deal with one health care provider or hospital in a marketplace, its competitive options are reduced to the benefit of the hospital that enjoys dominance among hospitals. "[T]he power equation moves much more strongly in that type of environment towards the provider [the dominant hospital] and away from the managed care companies." (Tr. 1471). Managed care companies who insure Hernando County residents have no alternative when it comes to open heart surgery and angioplasty services but to deal with Bayonet Point. With a 94 percent share of the Hernando County residents in need of open heart and angioplasty services, there is virtually no competition for Bayonet Point in Hernando County. The managed care contracting for both Bayonet Pont and Oak Hill is done at HCA's West Florida Division office, not at the individual hospital level. Approving Oak Hill will not promote or provide competition for managed care. Approving Brooksville, on the other hand, will provide managed care competition over open heart and angioplasty services in Hernando County. Ability to Transfer Patients While transfers of Hernando County patients always produce some stress for the patient and are cumbersome as discussed above for the patient's loved ones, there is no evidence of transfer problems for Oak Hill that would rise to the level of "not normal" circumstances. Outcomes for patients transferred from Oak Hill to Bayonet Point on the basis of morbidity statistics, mortality statistics, length of stay, patient satisfaction, and family satisfaction are excellent. It is not surprising that sister hospitals situated as are Oak Hill and Bayonet Point would enjoy minimal transfer delays and access problems encountered when patients are transferred. Transfers between unaffiliated hospitals are not normally as smooth or efficient as between those that have some affiliation. Unlike Oak Hill's patients, Brooksville patients, for example, are never transported for OHS/angioplasy by Bayonet Point's private ambulance. Other than in emergency cases, Bayonet Point decides the date and manner when the patient will be transferred. But just as in the case of Oak Hill, there is no evidence of transfer problems between Brooksville Regional and Bayonet Point that would amount to an access problem at the level of "not normal" circumstances. Outmigration As detailed earlier, there is extensive outmigration of Hernando County residents to District 5 for open heart and angioplasty procedures. The outmigration pattern on its face is in favor of both applications of Oak Hill and Brooksville. The outmigration from Hernando County, however, is of minimal weight in this proceeding since Bayonet Point is so close to both Oak Hill and Brooksville. The patients at the two Hernando hospitals have good access to Bayonet Point, a facility that provides a high level of care to Hernando County residents in need of open heart surgery and angioplasty services. The relationship is inter-district so that it is true that there is outmigration from District 3. Outmigration statistics showing high outmigration from a district have provided weight to applications in other proceedings. They are of little value in this case. Location of the Two Hernando Hospitals Brooksville is located in the "dead center" (Tr. 1290) of Hernando County. With good access to Citrus County via Route 41, it is convenient to both Hernando County residents and some residents of Citrus County. It reasonably projects, therefore, that 90 percent of its open heart/angioplasty volume will be from Hernando County with the remaining 10 percent from Citrus. Oak Hill is located in southwest Hernando County, closer to Bayonet Point than Brooksville. Oak Hill's primary service area is substantially the same as that part of Bayonet Point's that is in Hernando County. Oak Hill does not propose to serve Citrus County. Brooksville, then, is more centrally located in Hernando County than Oak Hill and proposes to serve a larger area than Oak Hill. Financial Feasibility (long-term) Brooksville has operated profitably since its bankruptcy. In its 1999 fiscal year, the first year out of bankruptcy, Hernando HMA earned a profit of $3 million. In fiscal year 200, Brooksville's profit was $6 million. OHS programs are generally very profitable. There is no OHS program in Florida not generating a profit. Brooksville's projected expenses and revenues associated with the program are reasonable. Schedule 5 in the Brooksville application contains projected volumes for OHS/angioplasty. The payer mix and length of stay were based on 1998 actual data, the most recent data for a full year available. The projected volumes are reasonable. The projected volumes are converted to projected revenues on Schedule 7. These projections were based on actual 1998 charges generated for both Hernando and Citrus County residents since Brooksville proposes to serve both. These averages were then reasonably projected forward. Schedule 7 and the projected revenues are reasonable. These projected volumes and revenues account for all OHS procedures performed in Hernando and Citrus Counties in 1998 even though effective October 1, 1998, the DRG procedure codes for OHS procedures were materially redefined. Thus, when Brooksville's schedules were prepared using 1998 data, only 3 months of data were available using the new DRG codes. Brooksville opted to use the full year of data since using a full year's worth of data is preferable to only 3 months. Similarly, the DRGs for angioplasty both as to balloon and with stent were re-classified. Again, Brooksville opted to use the full year's worth of data. Brooksville's expert explained the decision to use the full year's worth of data and the effect of the DRG reclassification on Brooksville's approach, "We've captured all the revenues and expenses associated with these open heart procedures and just because the actual DRGs have changed, doesn't . . . impair the results because both revenues and expenses are captured in these projections." (Tr. 1651). Schedule 8 includes the projected expenses. It included the health manpower expenses from Schedule 6 and the project costs from Schedule 1. The remaining operating expenses were based upon the actual costs experienced by all District 3 OHS providers generated from a publicly-available data source, and then projected forward. As to these remaining operating costs, consideration of an average among many providers is far preferable to relying on just one provider. Schedule 8 was reasonably prepared. It accounts for all expense to be incurred for all types of OHS and angioplasty procedures. It is based on the best information available when these projections were prepared and are based on 12 months of actual data. Even if the projections of the schedules are not precise because of the re-classification of DRGs, they contain ample margins of error. Brooksville's financial break-even point is reached if it performs 199 OHS and 100 angioplasty procedures. This low break-even point provides additional confidence that the project is financially feasible. Brooksville demonstrated that its proposed program will be financially feasible.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order that grants the application of Citrus Memorial (CON 9295) and denies the applications of Oak Hill (CON 9296 )and Brooksville Regional (CON 9298). DONE AND ENTERED this 4th day of October, 2001, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of October, 2001. COPIES FURNISHED: Diane Grubbs, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Michael J. Cherniga, Esquire Seann M. Frazier, Esquire Greenberg Traurig, P.A. East College Avenue Post Office Box 1838 Tallahassee, Florida 32302-1838 Stephen A. Ecenia, Esquire Rutledge, Ecenia, Purnell and Hoffman, P.A. 215 South Monroe Street, Suite 420 Tallahassee, Florida 32302-0551 James C. Hauser, Esquire Metz, Hauser & Husband, P.A. 215 South Monroe Street, Suite 505 Post Office Box 10909 Tallahassee, Florida 32302 John F. Gilroy, III, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403
Findings Of Fact At all times material hereto, Respondent has been licensed to practice medicine in the State of Florida, having been issued license number ME-0027913, and was employed by the Norton Seminole Medical Group in Pinellas County, Florida. Respondent has been licensed in Florida since 1976. At approximately 3:50 p.m. on November 1, 1983, a 31 year old white male, with the initials R. L., arrived at the emergency room of Lake Seminole Hospital, Seminole, Florida, and was examined by the emergency room physician on duty. R. L. complained of substernal mid-chest pain radiating to his back, which had begun the night before. He was agitated and exhibited a great deal of emotional stress. The emergency room physician on duty treated R. L. for suspected cardiac pathology, placed him on a cardiac monitor, inserted a heparin lock into a vein, and ordered lab work which included a chest x-ray, electrocardiogram, electrolytes, cardiac enzymes, CBC (complete blood count), blood sugar, creatinine and BUN (blood urea nitrogen). These were appropriate tests under the circumstances. When the Respondent came on duty in the emergency room at 7:00 p.m., all lab work had been completed, except for the cardiac enzymes. The emergency room physician who had been on duty when R. L. appeared at the emergency room briefed Respondent about R. L.'s medical history, condition while in the emergency room, and the test results which had been received. After the cardiac enzyme values were received, Respondent reviewed R. L.'s medical history and lab test results, which he determined to be normal, and discharged R. L. at approximately 7:35 p.m. on November 1, 1983, with instructions that he see his family physician the next morning. Respondent's discharge diagnosis for R. L. was atypical chest pain secondary to anxiety. At approximately 11:21 p.m. on November 1, 1983, R. L. expired from cardiopulmonary arrest at the emergency room of Metropolitan Hospital, Pinellas Park, Florida. The autopsy report notes extensive coronary artery disease, but makes no mention of acute myocardial infarction. It was not established by clear and convincing evidence that R. L. suffered an acute myocardial infarction. There is conflicting expert testimony from Steven R Newman, M.D., and Stephen J. Dresnick, M.D., concerning whether Respondent should have admitted R. L. to Lake Seminole Hospital instead of discharging him from the emergency room, and also whether his E.K.G. taken at the emergency room was normal. Drs. Newman and Dresnick are experts in the care and treatment of patients in an emergency room, but their testimony was received by deposition instead of through live testimony at hearing. Thus, based upon this conflict in testimony, and the fact that the demeanor of these witnesses cannot be assessed, it is found that it was not established by clear and convincing evidence that Respondent failed to practice medicine with that level of care and skill which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances when he discharged R. L., and evaluated the tests which were administered to the patient while in the emergency room as within normal limits. A patient who appears at a hospital emergency room with unstable angina, such as R. L., does not necessarily require admission to the hospital. While serial electrocardiograms and serial cardiac enzymes are called for with patients whose symptoms of cardiac discomfort warrant hospitalization, these procedures are not usually and customarily performed in an emergency room. Therefore, since it was not established that Respondent should have admitted R. L. to the hospital as an in-patient, it was also not established that he failed to exercise the required level of skill and care by failing to order such serial tests while R. L. was in the emergency room. Although the emergency room physician on duty when R. L. arrived at the emergency room at approximately 3:50 p.m. on November 1, 1983, was initially responsible for obtaining a patient history and ordering the tests which were performed, when Respondent came on duty at 7:00 p.m. and took over this case, he was also responsible for insuring that his medical records concerning his evaluation and treatment of R. L., as well as his decision to discharge the patient, were full and complete. Respondent failed to document his review and findings based upon the lab tests and chest x-ray which had been completed, as well as the patient's medical history, and the specific reason or basis for his decision to discharge R. L. Respondent relied almost completely on the medical records compiled by the emergency room physician who was initially on duty when R. L. arrived at the emergency room, and made no significant additions to those records while the patient was under his care, or which would justify his course of treatment, including discharge, of this patient.
Recommendation Based upon the foregoing, it is recommended that the Board of Medicine enter a Final Order reprimanding Respondent for his violation of Section 458.331(1)(m), Florida Statutes, and placing him on probation for a period of six months from the entry of the Final Order in this case, conditioned upon his complying with such reasonable terms and conditions as the Board may impose, including review and verification of the completeness of medical records prepared by the Respondent while on probation. DONE AND ENTERED this 5th day of July, 1990 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 5th day of July, 1990. APPENDIX (DOAH CASE NO. 89-6874) Rulings on the Department's Proposed Findings of Fact: 1-2. Adopted in Finding of Fact 1. 3-4. Adopted in Finding of Fact 2. 5-6. Adopted in Finding of Fact 3. 7. Adopted in Finding of Fact 4. 8-9. Rejected in Finding of Fact 5. 10. Rejected in Finding of Fact 4. 11-12 Rejected in Finding of Fact 6. 13. Adopted in part in Finding of Fact Rejected in Findings 5 and 6. 7, but otherwise Rulings on the Respondent's Proposed Findings of Fact: Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2 and 3. 4-5. Adopted in Finding of Fact 2. 6. Adopted in Finding of Fact 3. 7-9. Adopted in Finding of Fact 4. Rejected in Finding of Fact 5. Rejected in Finding of Fact 7. 12-13. Adopted in Finding of Fact 6. Adopted in part in Finding of Fact 2, but otherwise Rejected in Finding of Fact 5. Adopted in Finding of Fact 5. Rejected in Finding of Fact 7. COPIES FURNISHED: Andrea Bateman, Esquire Kevin F. Dugan, Esquire 1940 North Monroe Street Wittner Centre West Suite 60 Suite 103 Tallahassee, FL 32399-0792 5999 Central Avenue St. Petersburg, FL 33710 Kenneth E. Easley, Esquire General Counsel 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact At all times material, Respondent was licensed as an osteopathic physician in the state of Florida, having been issued license number 050004170. Respondent practices in the field of general surgery, and at all times material to this action, Respondent was on staff as Chief of Surgery at the University Hospital, Holly Hill, Florida. The incident which gave rise to the charges herein arose on August 5, 1987 when Respondent inserted a chest tube into patient W.T.'s right chest wall so as to relieve a pneumothorax which had actually occurred in W.T.'s left lung. A pneumothorax is a pocket of air in the cavity surrounding the lung which causes the lung to contract upon itself. At all times material, Patient W.T. had a subcutaneous pacemaker on the left side of her chest. However, the evidence from all credible witnesses is consistent that pacemakers are routinely placed on either the right or left side and that there is no reasonable medical presumption that pacemakers are always placed in someone's left chest area. The subcutaneous pacemaker did not enter significantly into W.T.'s case management at University Hospital. It operated on "automatic" and since it did its job, none of the University Hospital physicians involved in W.T.'s care paid much attention to it. W.T. was admitted to University Hospital for treatment of a drug overdose on July 9, 1987. As a part of her treatment, an Ewald tube was inserted into her stomach by a physician other than the Respondent. Patient W.T. was discharged from the hospital on July 18, 1987 with a portion of the tube inadvertently left in her stomach and her esophagus. On July 21, 1987, W.T. was readmitted to University Hospital. She was suffering from septicemia and bilateral pneumonia. X-rays revealed that a portion of the tubing had not been removed. This tubing was removed by the Respondent via successful gastroesophagoscopy on July 23, 1987. At Respondent's order, W.T. was placed in the Intensive Care Unit (ICU) following the removal of the tube. Dr. Desai was called in as a pulmonologist. When W.T. had been admitted to University Hospital on July 21, 1987, she already had been in a "guarded" condition. Despite successful removal of the Ewald tube, W.T.'s overall condition continued to deteriorate. Prior to the night of August 4, 1987, W.T. had developed adult respiratory distress syndrome (ARDS) which involves a breakdown in the capillary barriers within the lung itself, resulting in a diffuse leakage of fluid throughout all of the air space of the patient's lung. Because of the patient's serious lung condition, Dr. Desai placed her on a volume respirator, and the respirator pressure (PEEP) was progressively increased during her admission until it was set at 20 PEEP at the time of the incident. Twenty PEEP is an unusually high level of respirator pressure which was necessary in this case because of the patient's severe lung problem. The volume respirator essentially breathed for the patient and involved a tube being secured in her mouth. Often, between her admission to the ICU and the date of the incident, W.T. had torn the respirator tube out of her mouth, so she had been continuously restrained and sedated to keep this from happening again. Each time W.T. had extubated herself she had been "blue coded," meaning she had suffered either cardiac arrest or shock. Whether or not W.T. weighed between 225 and 250 pounds or weighed 350- plus pounds cannot be determined with any reasonable degree of accuracy since there is equally credible evidence over the entire foregoing range of poundage. It is material, however, that by all accounts of all witnesses, W.T. was markedly and grossly obese to the extent that her size, shape, and weight contributed to her several health problems and rendered her a patient more difficult to diagnose, more difficult to x-ray, more difficult to move, and more difficult to nurse and medically attend than she would have been otherwise. The evidence as to whether W.T.'s obesity impeded medical personnel from correctly interpreting her breath sounds on August 5, 1987, the date of the incident, is divided, as is the evidence as to whether or not on that date W.T.'s pacemaker was visible to the naked eye, but upon the greater weight of the credible evidence as a whole, it is found that on August 5, 1987, W.T.'s obesity, generally deteriorated condition, and left pneumothorax rendered the presence, volume, and location of breath in each lung subject to interpretation and "judgment call," and that unless one were specifically looking and feeling for a pacemaker, one would not necessarily have been able to detect the pacemaker in W.T.'s left chest due to the extraordinarily heavy pad of fat and the absence of scarring in that location. The foregoing finding of fact has been reached because with the exception of the complaining witness, Nurse Counihan, all factual witnesses either testified that they did not notice a pacemaker scar or they specifically noticed there was no scarring on W.T.'s chest. Also, with regard to breath sounds, both Mr. Starr and Respondent listened for W.T.'s breath sounds on the morning of the incident and within a very few minutes of each other. Mr. Starr described W.T.'s breath sounds when he entered her room as decreased on the right and absent on the left. His findings were consistent with a left pneumothorax but he never informed Respondent what he had found. Respondent arrived only a few minutes later and could not get any breath sounds from either side. Dr. O'Leary, accepted as an expert in pulmonology and the insertion of chest tubes, opined persuasively that one could not rely on breath sounds to locate which side the pneumothorax was on in the face of a recent x-ray. Also, the use of the respirator could have been misleading to either or both Mr. Starr or Respondent. X-rays taken of W.T.'s chest at least ten times between July 23, 1987 and July 31, 1987 clearly depict that the pacemaker was on the left side of W.T.'s chest. These x-rays were reviewed by Respondent with a radiologist the day before the events which are the focus of these charges took place. The radiology reports of W.T.'s chest x-rays dated July 25, 1987, July 28, 1987, and July 31, 1987 specifically mention the pacemaker but only the report dated July 28, 1987 states that the pacemaker overlies the left thorax. Respondent did not review any narrative reports when he and the radiologist were reviewing the actual x-rays together. There is no evidence that this procedure was outside the appropriate standard of care. Dr. Dworkin, expert in radiology and quality assurance and review, Dr. O'Leary, and Dr. Rosin, Petitioner's internal medicine expert, all testified that it is not below the professional standard of care for a treating physician to forget within a day after such an x-ray review which side a pacemaker is on unless the pacemaker enters significantly into his treatment of the patient, which in this case it did not. By the early morning hours of August 5, 1987, W.T. had become even more critically ill with multiple system failures, including a failure in the cardiopulmonary systems, a neurological deficit, and failure of her renal functions. The mortality rate of a patient suffering from ARDS, without considering the other conditions from which W.T. was suffering, exceeds 50%, and responsible medical retrospective estimates made at formal hearing of W.T.'s specific survival chances in the early morning hours of August 5, 1987 fall in the 10-50% range. During the early morning hours of August 5, 1987, the nurses on duty in ICU were having trouble maintaining W.T.'s blood pressure. They began telephoning Dr. Desai and Respondent at approximately 4:00 a.m. One of those doctors, most probably Dr. Desai, ordered a portable chest x-ray of W.T., which was accomplished at 6:30 a.m. by Josephine Christnagel, R.T., who is a registered x-ray technologist. At the time this x-ray was performed, W.T. was already in critical condition and could not speak or respond. W.T.'s condition was such that she probably was not salvageable when Respondent arrived on the scene at 7:00 a.m. on August 5, 1987. Unbeknownst to anyone at this point in time, the 6:30 a.m. x-ray had been inadvertently mislabeled by Ms. Christnagel so that the left side of the patient's chest appeared on the x-ray with a lead marker, "R" (for "right") , on it. This chest x-ray revealed that W.T. had a pneumothorax, and because it was mislabeled, the pneumothorax appeared to be on the right side. If a chest tube is properly inserted from the outside chest wall on the side of the pneumothorax, into the chest cavity, the air can be released and the lung can re-expand, delivering oxygen to the patient and raising blood pressure to normal. At all times material on August 4-5, 1987, the ranking ICU nurse on W.T.'s case was Carey Beninger ne' Counihan, R.N. The ICU nurses notified Dr. Desai by phone of the pneumothorax and he, in turn, notified Respondent. Because Respondent was more nearly ready to go to the hospital, Respondent rushed to the hospital to insert a chest tube into W.T., treatment which he and Dr. Desai, the attending pulmonologist, had agreed was the appropriate treatment for W.T.'s pneumothorax. For the reasons given infra with regard to the time the nurses' notes were compiled and Nurse Counihan's confusion over the x-ray itself, the evidence is not clear and convincing that Respondent was ever told by Dr. Desai or by the nurses by phone that the pneumothorax was on W.T.'s left side (the correct side). Even if Respondent had been so informed by Dr. Desai, since Dr. Desai had never seen the x-ray, it still would have been appropriate for Respondent to rely on the x-ray itself once he got to the hospital, unless at the hospital, something or someone clearly alerted him to the fact that the pneumothorax was actually on the left side. At approximately 7:00 a.m., just prior to the arrival of Respondent, Dr. Michael Danzig, D.O., who was the day-shift emergency room doctor, and Wesley Starr, R.P.T., a respiratory therapist, arrived at ICU and entered W.T.'s room. At approximately the time they arrived, the night-shift emergency room doctor, Dr. Haas, left the room. By all accounts, there was a continuing "commotion," a "ruckus," or "an emergency situation" in progress with at least two nurses, including Nurse Counihan, and other personnel providing various therapies to W.T. who had no palpable blood pressure and was in shock. This atmosphere continued after Respondent arrived shortly thereafter, with the nurses' and Mr. Starr's attention directed to care of the patient. When Respondent arrived, Dr. Danzig became, essentially, an observer. Upon arrival at W.T.'s room, Respondent examined the 6:30 a.m. x-ray against a window with daylight showing through. The x-ray, as it was mismarked, showed a massive tension pneumothorax on W.T.'s right side and a pacemaker on the same side, the right. After review of the x-ray, Respondent examined W.T., including listening for breath sounds. He heard nothing significant from either lung. Dr. O'Leary's opinion that such a finding was not unusual and that Respondent could not rely on either his own examination of breath sounds or that of Mr. Starr (had he even known of Mr. Starr's hearing breath sounds on the right but not the left) at that point is persuasive. Under these circumstances, breath sounds would not have alerted Respondent to a mislabeled x-ray. Respondent relied on the mislabeled x-ray and began to prep the right side of the patient for the chest tube. As Respondent began to prep W.T.'s right side, a dispute arose between himself and Nurse Counihan. Having weighed and evaluated all the testimony and the documentary evidence and exhibits, having reconciled that evidence which can be reconciled, and having eliminated that evidence which is not credible, it is found that the most credible version of this dispute is that Nurse Counihan asked Respondent why he was prepping the right side if W.T. had a left pneumothorax, and Respondent replied, "No, it isn't. Look at the x-ray." To this, Nurse Counihan said, "Yes, it is. I'm sure of it," and pointed to the lung on the x-ray which did not show a pneumothorax (the side next to the nameplate and the side without either a pacemaker or a pneumothorax). Respondent said, "No, it isn't. Look at the damn x-ray!" Respondent then proceeded to intubate on the right side while referring frequently to the mislabeled x-ray. In making the foregoing finding, it is noted that there were significant differences between the testimony of Nurse Counihan and all other witnesses, both factual and expert. Nurse Counihan deposed/testified that both she and another nurse had pointed out to Respondent that the patient's pacemaker was on the patient's left side and so was the pneumothorax. The other three factual witnesses, Starr, Danzig, and Respondent, all testified that they have no recollection whatsoever of anyone mentioning a pacemaker. Even Wesley Starr, called by the Petitioner, and who was present in W.T.'s room at the head of the patient's bed throughout the time of these discussions, testified that, to the best of his recollection, no one mentioned a pacemaker and that he did not recall anyone except Nurse Counihan challenging the Respondent's prepping W.T.'s right side. Also, Dr. Danzig, who was present in the room during the argument, and who testified that he had placed over 200 chest tubes during the course of his medical residency training, testified that if Nurse Counihan had, indeed, mentioned a pacemaker, he would have intervened in order to assist Respondent in determining the correct side of the pneumothorax. Although Petitioner asserted that Dr. Danzig is not credible due to his friendship with Respondent, that argument is not persuasive both due to the remoteness and degree of the friendship and Dr. Danzig's insistence that if Respondent should say that Nurse Counihan pointed to the side of the x-ray showing the pacemaker, then Respondent would be wrong. Respondent apparently did not review W.T.'s records either before or after the dispute with Nurse Counihan. These records were either in her room or elsewhere in the ICU unit, but since, at that point, the nurses' notes had not been compiled from their scratch pads to the patient's chart since before 4:00 a.m., there was nothing in W.T.'s chart/records to alert Respondent that the x- ray was mislabeled or that the patient had a pneumothorax on the left side even if he had reviewed the record. Also, he would have had to go back to the July 31 x-ray or the July 28 radiology narrative before he could have discovered that the pacemaker was on the left. This would have been very time consuming. Also, Dr. Danzig, who actually had made a cursory review of the patient's records when he first arrived in the room, was not alerted by Nurse Counihan's words or her pointing to the x-ray to any reason to search the records for information about the pacemaker. In further assessing Nurse Counihan's testimony, the undersigned has weighed in her favor the consistency of her recent deposition testimony with her notes and the incident report which she completed within five hours after the intubation incident on August 5, 1987. However, weighing against her credibility with regard to her statements then and now that she told Respondent that the pacemaker was on W.T.'s left side is the fact that even her August 5, 1987 report and notes were prepared in the glow of a hindsight favorable to her position and that her deposition shows that she is confused about how a pneumothorax appears on an x-ray. Reconciling all the testimony one can, it is remotely possible that Nurse Counihan said, "It is a left pneumothorax," while pointing to the lung shown on the x-ray as not having a pneumothorax and which, due to the "R" marker on the other lung could be inferred to be the left lung. It is even remotely possible (although not probable or persuasive given the three other factual witnesses' testimony that she had never mentioned a pacemaker) that Nurse Counihan could have told the Respondent, "The pneumothorax is on the same side as the pacemaker," which also was consistent with the x-ray as mislabeled. However, upon the credible evidence as a whole, the only reasonable conclusion is that if Nurse Counihan did mention a pacemaker at the time of her dispute with Respondent, she was ineffective in clearly conveying to Respondent or to anyone else in the room that the pacemaker and the pneumothorax were on the patient's left side or that there was any reason to further search the records or the patient's body to resolve the dispute. It is uncontroverted that, prior to the insertion of the chest tube in W.T.'s right side, absolutely no one, including Nurse Counihan, was aware that the x-ray was reversed, and that Ms. Counihan never informed the Respondent that the x-ray was reversed. Respondent's testimony is accepted that upon placement of the chest tube in W.T.'s right side (the side without the pneumothorax) he heard an immediate audible gush of air. That others in the room did not hear this rush of air is understandable due to the noise and confusion in the room, particularly the respirator sounds. Also, it is uncontroverted that upon placement of the chest tube in W.T.'s right side, the patient's blood pressure, which had been zero, immediately rose into normal range. A dramatic and rapid reestablishment of the patient's blood pressure is the expected result of a proper placement of a chest tube with a tension pneumothorax. All health care personnel present seem to have regarded the blood pressure stabilization as proof that the Respondent had placed the chest tube on the correct side of the patient, because no one, including Nurse Counihan, thereafter protested that a misplacement had occurred. Release of pressure and a return in blood pressure is not normally associated with placement of a chest tube in the wrong side of a patient and there is no definitive medical explanation of why it occurred in this instance, despite Dr. O'Leary's speculation that the gush of air could have been a leak of air across the Mediastrum. After placement of the chest tube in the patient's right side, Respondent ordered an immediate repeat chest x-ray to be certain the tube was placed in the correct lung and was placed correctly. After the patient's blood pressure had been reestablished, Dr. Danzig left the intensive care unit because he believed that the pneumothorax had been relieved completely and because the patient was now stable. If W.T. had not been stable, Dr. Danzig would have remained in the room since he was the day- shift emergency room doctor and he did not know if any physicians other than Respondent and himself were even in the hospital yet. After securing the chest tube and dressing the chest, Respondent left the floor and went to the operating room (OR) to notify the OR staff that there would be a delay before he could begin previously scheduled surgery. Thereafter, on his way to check the new x-ray he had just ordered, Respondent met Ms. Christnagel, who was bringing it to him. Ms. Christnagel then informed Respondent that she had mislabeled the 6:30 a.m. preintubation x-ray. Respondent simultaneously reviewed the new, postintubation x-ray and discovered that he had placed the chest tube in the wrong side of W.T.'s chest. At approximately the same time, W.T.'s blood pressure again dropped and a "code blue" was called. Dr. Gloria Mikula, M.D., who happened to be in the ICU at the time W.T. coded, "ran the code" to attempt to reestablish the patient's blood pressure. Throughout the time in which Dr. Mikula was running the code on this patient, no one, including Nurse Counihan, said anything to the effect that W.T. may have had a chest tube placed in the wrong side. In fact, the nursing staff did not even inform Dr. Mikula that this patient had had a pneumothorax and chest tube insertion prior to the code being called. Such information would have been important from a medical standpoint because it would have allowed Dr. Mikula to act immediately to relieve the tension in the patient's chest. Immediately upon reviewing the repeat chest x-ray and upon hearing the announcement of the code blue at the same time, Respondent rushed back to W.T.'s room, placed a chest tube in the patient's left side, and the patient's blood pressure was again reestablished. However, some time later in her hospitalization, W.T. expired. Nurse Counihan's failure to say anything to Dr. Mikula about the pneumothorax is further indicative of her immediate satisfaction that Respondent's intubation on the right side had been acceptable and that it was only after he discovered his error through the new x-ray and correctly intubated W.T. on the left side that Nurse Counihan completed her notes and incident report describing his error for the chart. The notes were transposed from her scratch pad and memory at approximately noon, August 5, 1987. Dr. Rosin, Petitioner's expert in internal medicine, criticized Respondent's performance as below the professional standard of care because he felt that once Respondent was made aware in the patient's room by Nurse Counihan that the pneumothorax could be on the patient's left side, Respondent had an obligation to make further inquiry or investigation before inserting the chest tube in the patient's right side. In Dr. Rosin's opinion, Respondent's investigation could have taken several routes: review of earlier x-rays and the patient's record, further conversation with the nurse, further hands-on examination of the patient for signs of the pacemaker, and/or ordering a new x- ray. Although Dr. Rosin testified that Respondent should have ordered a repeat x-ray so as to resolve the dispute with Nurse Counihan before inserting the chest tube on W.T.'s right side, he also conceded that the only possible adverse effect of the decision Respondent made was the delay in relieving W.T.'s condition. The chest intubation involved is not a benign or casual procedure, but no actual harm occasioned by misplacement of the chest tube was demonstrated in this case, and the maximum amount of time which would have been saved, under Dr. Rosin's approach, would have been that short period of time it took for the Respondent to place the chest tube and dress the wound. Under the circumstances, if Respondent had delayed intubation, W.T. would probably have "coded blue" before the correctly labelled chest x-ray could have been performed anyway. In light of the confused state of the patient's breath sounds, obesity, and lack of scarring, the fact that no nurses' notes had been codified since before 4:00 a.m., Nurse Counihan's own confusion about the mismarked x-ray, and how far back in the patient's chart Respondent would have had to look before he would have been able to locate anything useful about the pacemaker, it is found that Respondent behaved reasonably in an emergency situation, and Dr. O'Leary's and Dr. Dworkin's expert opinions that he did not violate the professional standard of care in the first insertion of the chest tube are accepted. It is also found that the Respondent's procedure in ordering the new chest x-ray and leaving the room after the first intubation without further search of the records or further conversation in the room was reasonable and appropriate under the circumstances.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Physicians enter a Final Order dismissing all charges against Respondent. DONE and ENTERED this 25th day of July, 1991, at Tallahassee, Florida. ELLA JANE P. DAVIS 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 25th day of July, 1991.
The Issue The issue is whether Respondent practiced medicine within the applicable standard of care, as required by Section 458.331(1)(t), Florida Statutes, and, if not, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 30404. He earned his medical degree in 1974. Respondent has been Board-certified in the specialty of internal medicine since 1977 and in the subspecialty of cardiovascular disease since 1981. At the time of the incident in question, Respondent was a staff cardiologist with the Cleveland Clinic Florida, which is located in Fort Lauderdale. At present, he is an attending cardiologist with the Broward General Medical Center, which is located in Fort Lauderdale. H. T., a 58 year-old male, was scheduled for a spinal fusion on January 5, 1993, at the Cleveland Clinic Florida. This back surgery was expected to take 8-10 hours. Although the surgery was not an emergency, H. T. was suffering from complex pain that was worsened by standing, walking, and bending forward and was intensifying with time. Dissatisfied with his current level of functioning, H. T. was a suitable candidate for back surgery, based on his symptoms and diagnosis. On December 30, 1992, H. T., now suffering "severe" lower back pain, reported to the Cleveland Clinic Florida for a preoperative evaluation. He took a resting electrocardiogram (EKG). The computer program that interpreted the results identified a possible inferior myocardial infarction of an undetermined age and a possible left atrial enlargement. Another cardiologist with the Cleveland Clinic Florida, Dr. Vincent Font, examined the computer-generated interpretation and did not reject it. The radiology report from the December 30, 1992, examination was completed by Dr. Robert J. Hyman of the Cleveland Clinic Florida. The report notes that H. T.'s heart was enlarged. Due to the results of the preoperative evaluation done on December 30, 1992, H. T. had to obtain a cardiac clearance before his back surgery on January 5, 1993. Thus, on January 4, 1993, H. T. presented to Respondent at the Cleveland Clinic Florida to obtain a cardiac clearance. On January 4, 1993, H. T. provided Respondent with a history of 60 pack-years of cigarette smoking, which had been discontinued two months earlier. Respondent's blood pressure was 196/98. He stood five feet, eleven inches, and weighed 192 pounds. Based on the values considered normal at the time, H. T.'s blood pressure was somewhat elevated and his weight was somewhat excessive. However, H. T.'s only significant cardiac risk factors were his history of cigarette smoking and, to a lesser extent, his age. Respondent administered a stress EKG on January 4, 1993. The report states: This patient had uneventful pre-exercise maneuvers and then had a sub-maximal level exercise performance limited by left leg pain. He exercised for 6 min. according to the modified Bruce protocol. Patient attained a maximum heart rate of 124 bpm which was 76% of the maximum predicted heart rate of 162 bpm. There was exaggerated blood pressure reaching a maximum of 242/104 during peak exercise. Test was terminated because of leg and back pain. There was no ventricular hypertrophy with upsloping ST segment depression of about 2 mm. in the inferior and lateral leads, consistent with secondary changes due to LVH. Post-exercise recovery phase was uneventful. Respondent added the following clinical impressions to the report: No chest pain during exercise. Adequate functional capacity limited by left leg pain. Abnormal EKG due to left ventricular hypertrophy with secondary ST T-wave abnormalities. The most important part of Respondent's physical examination of H. T. was his observation of the exercise stress test. At no time during or after the test did H. T. exhibit any sign of cardiac insufficiency, such as shortness of breath or pallor. Nor did H. T. experience any pain in the front of his chest. Respondent also examined H. T.'s medical records, in which H. T. reported a cerebrovascular accident, seizures, and a transient ischemic attack. However, this history was contradicted by other history provided by H. T. ten weeks earlier, at which time H. T. had denied any history of convulsions or strokes. Discussing the history with H. T., Respondent learned that H. T. had erroneously indicated that he had suffered these three conditions. After examining the relevant information, Respondent concluded that, within a reasonable degree of medical probability, H. T. was appropriate, from a cardiac perspective, for serious orthopedic surgery. In his consultation report, Respondent noted that H. T. denied any history of hypertension, and Respondent suggested that H. T.'s blood pressure was high due to anxiety over surgery. The report also notes that H. T. denied chest pain at rest or under exertion and also denied shortness of breath or other symptoms of heart failure. Regarding the electrocardiogram, the consultation report states that H. T. displayed a normal sinus rhythm and his septal Q-saves were consistent with early left ventricular hypertrophy, which was consistent with possible mild hypertensive heart disease. Regarding the stress EKG, the consultation report states that H. T. achieved exaggerated blood pressure response with frequent premature atrial contractions, although these were of minor significance. The report notes that the EKG pattern was characteristic of left ventricular hypertrophy with secondary ST T-wave abnormality. The report suggests that H. T. have his blood pressure rechecked. Central to Respondent's cardiac clearance of H. T. for extensive back surgery was the fact that the stress EKG subjected H. T. to more stress than he would experience during and after surgery, the test adequately raised H. T.'s blood pressure, and the EKG returned to normal once H. T.'s blood pressure returned to normal. Respondent placed considerable emphasis on H. T.'s cardiac response to six minutes' stress, under the modified Bruce protocol, without experiencing pain. Respondent terminated the test due to leg pain that was consistent with the symptoms to be alleviated by the back surgery. After Respondent cleared H. T. for back surgery, the surgery took place on January 5, 1993. H. T. emerged from 11 hours of surgery in stable condition. When he awakened postoperatively, H. T. followed commands and spoke with his wife. However, early the next morning, H. T. suffered respiratory depression. His treating physician withdrew the morphine that H. T. had been receiving; after responding well, H. T. again exhibited respiratory depression, rapidly followed by respiratory arrest. H. T. fell into a coma, secondary to a deprivation of oxygen to the brain. However, he did not exhibit signs of an acute myocardial infarction and never displayed any signs suggesting that he had not tolerated the surgery well from a cardiac perspective. After the withdrawal of certain life- support interventions, H. T. died on January 22, 1993. An autopsy took place about seven hours after H. T. died. The autopsy found that all three major vessels constituting the coronary arteries were more than 90 percent occluded. However, a serial section of the myocardium did not reveal definite recent or remote infarcts. The medical examiner concluded that there was "no clear cut finding to explain the course of [H. T.]" and that further examination of abnormalities in the heart and brain would be necessary. Subsequent examination of the heart resulted in findings of, among other things, "severe" coronary atherosclerosis with 90 to 95 percent narrowing and concentric left ventricular hypertrophy. A cardiologist performing a cardiac clearance must take the patient's history, perform a physical examination, examine relevant medical records, and finally evaluate the patient and stratify the cardiac risk posed by the subject surgery. Respondent performed all of the necessary steps of a cardiac clearance in evaluating the likelihood that H. T. could undergo extensive back surgery without serious cardiac complications. The abnormalities in H. T.'s EKG during the stress test most likely suggested the presence of left ventricular hypertrophy, not a myocardial infarction. Left ventricular hypertrophy is consistent with several other factors suggestive of longstanding hypertension. Moreover, a cardiac clearance for noncardiac surgery is generally appropriate if the patient, as did H. T., completes six minutes of the stress test, elevates his blood pressure and pulse, experiences no chest pain, and displays no pallor. The cardiac clearance of such a patient is appropriate even though he suffers from an underlying cardiac disease. The postmortem findings of atherosclerotic disease do not establish functional cardiac disease. The postmortem findings cannot assess the extent of occlusion of vessels under pressure, as opposed to vessels no longer under pressure. Also, the postmortem findings do not assess the vulnerability of the plaque. Petitioner has failed to prove that Respondent's cardiac clearance of H. T. deviated from the applicable standard of care. H. T. required intensive back surgery to obtain relief from severe pain. The abnormalities reported in the resting EKG did not suggest a recent myocardial infarction. The abnormalities in the stress EKG likely revealed a thickening of the left ventricle, probably resulting from hypertension. These findings did not necessitate additional cardiac testing before clearing H. T. for extensive back surgery. Most significantly, H. T. underwent the rigors of the stress EKG without significant cardiac symptoms. An experienced cardiologist, Respondent assessed H. T.'s cardiac function under conditions that approximated the stress of the spinal fusion. Later, undergoing the surgery, Respondent suffered no cardiac problems. Even if Petitioner had proved an underlying cardiac condition, such as severe occlusion or a myocardial infarct, Petitioner did not prove that these conditions precluded H. T. from obtaining much-needed back surgery prior to resolving any and all underlying cardiac conditions.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 5th day of November, 2001, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 5th day of November, 2001. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 John E. Terrel, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Mail Stop 39-A Tallahassee, Florida 32317-4229 Paul R. Regensdorf Akerman, Senterfitt & Eidson, P.A. Las Olas Centre II, 16th Floor 350 East Las Olas Boulevard Fort Lauderdale, Florida 33301
Findings Of Fact The Respondent, Steven M. Van Ore, M.D. is a medical doctor holding license number ME0018621. The Respondent graduated from the University of Miami Medical School in 1970 and received his license to practice medicine in Florida in 1971. He served his internship and residency in internal medicine at Orange Memorial Hospital in Orlando, Florida, and became a diplomate of the American Board of Family Practice in 1977, certified in that area through 1990. The Respondent is currently engaged in the private practice of family medicine in Maitland Florida. Since 1976 he has held various academic posts, received a number of professional awards and has actively served in various medical societies and on various medical committees. The Petitioner is an agency of the State of Florida charged with regulating the licensure of physicians and enforcing the medical practice standards embodied in Chapter 458, Florida Statutes, the "medical practice act." In four separate counts, the Petitioner accuses Respondent of failing to prescribe certain Schedule II controlled substances to four different patients for medically justifiable purposes and charges him with prescribing them inappropriately or in excessive quantities. The substances involved are Mepergan Fortis, Demerol, Dilaudid, Percodan, Percocet, Tylox, Dolophine and Methadone. There is no question that the four patients involved in these counts suffered chronic, moderate to severe pain, for which they were treated by the Respondent. The Physician's Desk Reference, accepted by the parties as an authoritative indicator of appropriate drug usage including types and amounts for given diseases or conditions, places no limit on the amount of prescription of Schedule II controlled substances in question for patients suffering from chronic moderate o severe pain. Drs. William Story and Brouillett, accepted as expert witnesses, testifying on behalf of the Respondent in the above- mentioned areas of medical practice, based their expert testimony upon a complete review of the treatment records and charts of the four patients involved herein and in addition, Dr. Story had some firsthand knowledge of the patients' medical histories, conditions, problems and progress. Dr. Story also reviewed the hospital charts at the hospitals where each patient was sent from time to time when his review of Dr. Van Ore's own records revealed those hospitalizations. Dr. Handwerker, testifying as an expert witness for the Petitioner, did not review the hospital charts of these patients, nor familiarize himself with the necessity for their hospitalizations as that relates to the chronic severe nature of their pain and other ailments and the attendant appropriateness of the drugs prescribed for these patients by the Respondent. It was thus established that patient Josephine Inbornone was followed and treated by Dr. Van Ore from February 16, 1979 to December 9, 1980. During that time he saw her 20 times in the hospital and 20 times in his office. He also sought and obtained consultation with specialists Dr. Biggerstaff and Dr. Lett who saw her on a number of occasions, for a total of 28 office visits between the three of them. The patient suffers from a severe, chronic, low-back pain and chronic sciatica. During Respondent's "work-up" of the patient, she was tried on a variety of medications including Sinnequan and Tylenol 3, which she could not take because of allergies. She was allergic also to Percodan, Codeine, Darvon and Talwin. Her pain and discomfort could not be controlled with non-steroidal anti-inflammatory drugs. A trans-neuro stimulator was used, to no avail. Her severe back pain resulted in six different hospitalizations while she was under the care of Dr. Van Ore. The first hospitalization was in February, 1979 and she was later admitted on June 25, 1979 with acute diverticulitis. There was some evidence at this time that she also suffered from "anxiety neurosis." On June 3, 1980 she suffered a severe lumbrosacral strain from a fall on a wet floor in a store, which required hospitalization. She was again hospitalized on September 12, 1980 complaining of persistent abdominal pain and was hospitalized later that year with chronic, severe back pain. The patient was seen by Dr. Urbach on her sixth hospital admission for a psychiatric evaluation. By that time it was obvious to the Respondent that the patient had developed a drug problem because of her severe, chronic and disabling back pain which required chronic administration of narcotic drugs. Her condition was aggravated by the fact that she was markedly overweight (which strained her back) and because of her drug allergies which prevented her taking milder drugs. As part of her evaluation in the course of her various hospitalizations, she had a CT scan of the spine, extensive x- rays, barium enemas, upper GI x-rays and other tests designed to evaluate the nature and cause of her chronic, severe back pain as well as her recurrent abdominal pain. No major pathologic condition was found and she was felt to have an anxiety neurosis by the Respondent and Dr. Urbach. As early as February 23, 1979, upon her admission to Winter Park Hospital, the Respondent noted that she had a chronic problem with severe low back pain that seemed resistant to every drug for control of pain, including Vistiril, Percodan, Codeine, Darvon, Phenobarbital and Indocin. The Respondent further noted her allergic reaction to many of those drugs and, as early as that date, also noted that they were going to attempt to eliminate some of the medication she was taking because of concern about possible drug addiction. The Respondent's and other physician's inability to control her pain is evident by her multiple hospitalizations because of the debilitating nature of her pain which could not be alleviated without Schedule II narcotic type drugs. In short, the patient was clearly a difficult patient who had a psychiatric overlay which was noted by both Drs. Van Ore and Urbach. She suffered from severe low back pain as well as abdominal pain. Numerous attempts were made to discern the cause of these multiple admissions which were felt to be severe and functional in origin. Unquestionably her low back pain was aggravated by her multiple falls which she had had in the past, as well as by her chronic obesity. It is noteworthy that the Respondent involved consultants who documented the patient's severe back pain requiring the drug usage and that the Respondent noted early in his experience with the patient, that the drug usage should be tapered off as much as possible. It is also noteworthy that minor narcotic drugs such as Codeine, as well as non-steroidal, anti-inflammatory drugs, were tried first and were either unsuccessful or caused an allergic reaction. The multiple admissions to the hospital show a concerted effort to fully evaluate the patient's needs, a thorough attempt to find the cause for her severe pain and a means to alleviate it permanently. Nothing of a curative nature could be found so that she was left with a residual pain which ultimately led to a marked physical impairment. Narcotic Schedule II drugs were determined after numerous tests and evaluations and hospitalizations, to be the only means by which her pain could be alleviated. This was done with the open recognition, reflected in the Respondent's notes, that the chronic use of narcotic drugs could lead to both dependency as well as to drug tolerance, which would result in the need for heavier doses of the same drugs. With this in mind, the Respondent made an attempt to wean the patient away from Schedule II drugs as much as possible, and the patient ultimately went to another clinic specializing in the control of chronic, severe pain. Dr. Story opined after thoroughly reviewing the Respondent's charts and notes for this patient, as well as his hospital records related to her, that there was no evidence of malpractice or misuse of drugs. The need for narcotic drugs in this case was well documented, as were the attempts by the Respondent to try to wean her from narcotic drugs to the extent possible when balanced with the doctor's felt obligation to try to alleviate her pain with whatever means proved successful. In fact the Respondent attempted to use less potent drugs to the extent possible and only resorted to Schedule II narcotic drugs when the lesser drug proved either ineffectual or allergic. The Respondent's concern and attempts to get at the root cause of her pain is demonstrated by his reference of her to a number of other physicians, orthopedic surgeons, a psychiatrist as well as family far physicians, all of whom ultimately agreed that the pain seemed to be legitimate in nature and a source of great discomfort to the patient. Although Dr. Story, the Respondent and the other physicians who saw the patient were concerned about the narcotic drug dependency, Dr. Story opined that there was no evidence of misuse of drugs in this case in his professional opinion. The patient will always be a difficult patient for whomever takes care of her because of her chronic low back pain and the chronic anxiety overlay which often accompanies chronic, severe pain. He found the Respondent provided competent care for the patient with concomitant genuine concern for her narcotics requirement and her long term need for narcotic drugs. Robert Marsh began seeing Dr. Van Ore in 1981 for severe back pain caused by his having fallen from a scaffold on a construction site. At the behest of the Respondent, the patient was seen by several orthopedic and neurological specialists and was eventually diagnosed to have defects of the lower lumbar spine after a myelogram was performed. His back pain at this time was severe and he required narcotic drugs (Schedule II) for the relief of that pain. The patient was first seen on May 20, 1981 and was given Tylox and Robaxin. He was then referred to Dr. Martin Brown for evaluation. His back continued to be severely painful, ultimately requiring prescription of Dilaudid over the period of the next few months. At the same time he was treated conservatively, which is the usual course of practice in treatment for low back pain. He continued to suffer severe back pain, radiating into his extremities, however, requiring Dilaudid and Mepergan Fortis for relief. During the course of this conservative treatment and prescribing of narcotic medications, the Respondent expressed concern in his notes on August 27, 1981, that the patient might be developing a drug abuse potential. The plan thus was to commit him for hospitalization at that point. Concern was again expressed by the Respondent on October 7, 1981, that the chronic low back pain was requiring narcotic usage and that the patient would need weaning from the drug and perhaps a trial usage of Methadone. On October 20, 1981, the Respondent's notes reflect that he felt that the patient was addicted to Dilaudid, which is a common problem when narcotic drugs must be used for several months at a time for pain. Fortunately, the patient in early 1982, had surgery, a laminectomy, which almost totally relieved his back pain. The Respondent then successfully weaned him away from narcotic drugs. The patient's back pain had been severe and at times excruciating. CT scans and back x-rays, as well as myleogram studies, revealed a rupture of a disc in the lumbar area. These tests were performed by specialists to whom the Respondent had referred the patient. The pain had been present for approximately one and a half years by the time the patient first saw Dr. Van Ore. A complete evaluation was done by Van Ore as well as by the orthopedic specialist, Dr. Billotta, and a radiologist, to whom Van Ore referred the patient. It is noteworthy that a complete evaluation was done and consultation was obtained early in the patient's course of treatment with the Respondent, from practitioners in the above specialities. There is a significant danger, recognized in Respondent's own notes, of narcotic addiction through long term use of narcotic drugs to relieve pain, but these medications were the only thing that provided relief for the patient until ultimate evaluations and examinations revealed the necessity for surgery which finally got at the cause of his pain and alleviated it. The Respondent then followed up with the patient and successfully weaned him from his dependence on narcotics. Dr. Story opined that the patient was given the usual and appropriate care and treatment by the Respondent, who diagnosed his injury, tried conservative medical treatment at first, and employed the use of narcotic drugs appropriately since that was the only thing which proved to alleviate the excruciating pain the patient was suffering. Dr. Story opined that the Respondent's practice with regard to this patient was well within the limits of acceptable practice as recognized by similar physicians in the community, under similar conditions and circumstances. Mrs. Eleanor Rooker was also seen by Dr. Story as a patient for cardiac problems of a rather severe nature. She is a 55-year old female with a long history of chest pain and back pain. She had a colostomy due to ruptured diverticulun and has had recurrent admissions to the hospital for chest pain. Ultimately she was diagnosed as having arteriosclerotic heart disease, with multiple coronary lesions. Chronic angina is a major problem for her. The patient was also admitted on February 7, 1983, for severe low back pain with nerve root irritation as well as severe sciatica. A myleogram at that time indicated that there nay be a disc problem in her back. A thermogram of the back and lower extremities showed some signs of degenerative nerve conduction because of nerve root compression. The patient was obviously suffering from severe back pain and was treated by the Respondent with conservative bed rest, muscle relaxers and analgesic agents. Over the years the Respondent saw her, Eleanor Rooker had multiple admissions to hospitals for painful heart conditions involving angina, secondary to arteriosclerotic disease and in November 1980, for congestive heart failure. She has a chronic heart condition which ultimately required bypass surgery because of her severe coronary artery disease. Also, at least as early as her hospital admission of February 6, 1981, the patient developed severe tension headaches which caused severe, recurrent pain. The patient required large doses of medication to control her painful headaches and Dr. Mueller, a psychiatrist called in to see her concerning her headaches, found that the patient was dependent upon Darvocet which she was taking as a means to control the severe, chronic, headache pain. Thus, between the years 1980 and March, 1984, the patient was in the hospital numerous times and was referred by the Respondent to numerous specialists to try to get at the cause of her back pain as well as her chronic headache pain, wholly aside from the hospitalizations and treatment for her heart problems. During this time the Respondent and other specialists, such as Drs. Tatum and Brown, a psychiatrist and a neurologist, respectively, (who saw the patient concerning her severe headaches) agrcee that she had chronic, severe pain and a problem of narcotic dependence involving Fiorinal, Tylenol 3 and Darvocet. At least as early as October 3, 1981, when she was admitted to the hospital, Dr. Van Ore felt she was suffering from drug dependency and he made an effort to get her weaned away from narcotic drugs at that time. The patient obviously has very real, legitimate illnesses and conditions which cause her chronic, severe pain. All of these have combined to give the patient a great deal of distress and discomfort and has created a frequent need for narcotic drugs since milder drugs have not controlled her discomfort. Her legitimate medical illnesses are coupled with a psychiatric anxiety overlay because of the chronic, long-standing nature of her pain. Her illnesses are severe in nature, are very disabling and require large dosages of multiple narcotic medications. In time the patient did become dependent on Darvocet and required fairly large doses because chronic narcotic drug usage results in the development of a drug tolerance in many patients, requiring larger doses, progressively, to maintain analgesic effectiveness. In short, the patient suffered from a number of legitimate medical illnesses and a large number of sub-specialty consultants were asked to evaluate her multiple areas of pain, including Dr. Nosaro and Dr. Story himself for cardiac evaluation, Dr. Uricchio and Dr. Murray for musculoskeletal and lumbar pain evaluation, Drs. Modd, Brown and Dunaway for evaluation of severe headaches and lumbar pain; psychiatric consultation by Dr. Quinones and Dr. Paskiwitz. It was thus established that Dr. Van Ore made strenuous efforts to determine the cause of the patient's different medical problems, found no easy solutions for them and when confronted with the chronic pain the patient suffered, felt he had no choice but to prescribe narcotic drugs in increasingly large amounts as her tolerance increased. The doctor made concomitant efforts to wean her away from her narcotic drugs whenever possible. In Dr. Story's expert opinion, the Respondent applied diligent efforts to diagnose his patient's problems as well as to alleviate her suffering. Dr. Story feels that the Darvocet dependency that eventually evolved from her illnesses was an expected and likely complication because of the long-term use of narcotic pain relief, which is the only kind of relief that could be afforded the patient. In summary, Dr. Story established that good medical care was employed by the Respondent and the referred consultants who evaluated and treated this lady and there was no evidence of any misuse of narcotic drugs on the part of the Respondent or any of the consulting physicians, but rather the medical care afforded her met all professional standards. The remaining patient to whom the charges in the Administrative Complaint relate is Arthur Van Vlack. Mr. Van Vlack has suffered extremely painful migraine headaches over a period of many years. Dr. Van Ore has followed him as a patient for approximately ten years. The Respondent had the patient completely evaluated for neurological condition with regard to his migraine headaches, including admitting him to the hospital. The patient had seen many physicians for this problem. His headaches have not responded to usual medical treatment for migraine headache and he required, over the years, progressively larger doses of narcotic drugs. He has used at various times, Demerol, Percodan and Percocet, since lesser strength drugs have not controlled his severe pain. Additionally, the patient has had problems involving a duodenal ulcer, vagotomy and pyloroplasty in August of 1980. He suffers pain in the low back caused by spina bifida occulta in the area of the 5th lumbar vertebra. The only control for the patient's severe pain, which is chronic and recurrent, has been narcotic drugs. When the severe headaches strike, the patient loses his ability to earn a living and to conduct a normal life, and sometimes has to be bedridden for several days in extreme pain. Dr. Van Ore did a thorough evaluation of the patient, including CT scans and cervical myelograms, as well as lumbar myelograms in an attempt to find out if there were any correctable causes for the patient's pain. Neurological consultations were obtained, including a neurology consultation with Dr. Peritz Scheinberg, of the Department of Neurology at the University of Miami School of Medicine. The patient's charts uniformity indicate that for every office visit that the headaches are still persisting and that only Demerol and Percodan seem to benefit the pain. At times Talwin was tried, but to no avail. After a complete evaluation of the patient's headaches with every conceivable neurological test as well as consultation with Dr. Scheinberg at the University of Miami, no correctable cause for the man's pain was found. None of the consultants to whom the patient was referred by the Respondent, either neurologic or psychiatric, found that the headaches were other than legitimate, severe, refractory migraine headaches. Both the Respondent and the consultants to whom the patient was referred understood that the patient had a narcotic addiction problem as a result of years of narcotic usage since those were the only medications that would control his severe, disabling headaches. This kind of addiction, as well as the tolerance to lighter doses of medication normally occurs when narcotics are used over such an extended period of time. It is fully expected and largely unavoidable when treating severe, chronic disabling pain for which there is no ascertainable medical solution. Dr. Van Ore understood early in his following of this patient that the addiction was a distinct danger and sought a number of times to wean the patient off medications and to compromise and negotiate and try to persuade him to switch his medications from time to time in an attempt to wean him from narcotic drugs. By May of 1981 the Respondent was attempting to wean him from narcotic drugs by putting him on a schedule of progessively tapering doses. However, whenever the medications were decreased the headaches again became disabling to the patient. It was at approximately this time that the consultation with Dr. Scheinberg was obtained. It being a pharmacologic fact that as patients take narcotic drugs for relief of legitimate illnesses, for which there is no cure, with addiction and drug tolerance becoming a common problem, it is appropriate and correct practice for a family physician at this point, when confronted with such patients, to obtain expert, sub-specialty consultation with a variety of physicians. The Respondent did this in this case and in the others. A number of neurologists evaluated the patient and concluded as the Respondent had, that he suffered from severe, intractable migraine. Finally, the Respondent attempted to use psychiatric care in order to help wean the patient off the drugs, to little avail. Ultimately the Respondent admitted him for detoxification at Winter Park Hospital. Dr. Story opined, after thoroughly reviewing the patient's history and charts, that he saw nothing amiss about the quality of medical care and professional practice rendered the patient by the Respondent. He found the requirement for narcotic drugs to be understandable under the patient's circumstances, which admittedly aroused concern by the Respondent and the other physicians who followed him, for the patient's possible drug addiction due to long-term narcotic use. Dr. Story shared the concern by all involved physicians regarding the large amounts of medication that were required to control his pain, and points out that this is due to a drug tolerance developed by the patient. As a counter to this the Respondent made repeated attempts to wean him off narcotic drugs and toward the end of his relationship with the patient, he was approaching the point of weaning him off narcotic medication entirely. Dr. Story, in short, does not feel that medical practice standards employed by similar physicians under similar conditions and circumstances, involving a difficult patient with chronic severe pain, have been departed from. In summary, Dr. Story found, as did Dr. Brouillet, who largely corroborated the findings of Dr. Story, that the drugs employed with all four patients did not involve any drug misuse. Rather, the care and treatment provided these patients reflected a high level of skill and the Respondent tried in all ways known to him to evaluate the root cause of the patient's pain problems, including referral to appropriate specialists for all relevant evaluative techniques. Both Respondent's experts found no departure from appropriate and correct rendering of quality medical care to these patients. They were all very complex, difficult patients with chronic illnesses characterized by severe, chronic pain with, in some cases, psychological overlays, which is often the case with severe, recurrent pain. Thus, Drs. Story and Brouillet opined that the use of these drugs referenced in the Administrative Complaint, to relieve pain in these patients was legitimate as to appropriateness and amounts. Drs. Story and Brouillet, based their testimony and opinions upon a complete review of the treatment records of all four patients, and Dr. Story additionally reviewed the hospital charts at the hospitals of each patient. Dr. Handwerker, testifying for the Petitioner, did not have the benefit of the hospital records in arriving at his opinion. Although Dr. Handwerker opined that it is inappropriate to relieve the patient's chronic severe pain with recurrent use of Schedule II controlled substances, Dr. Story established that it is also a physician's duty and obligation to try to relieve a patient's pain, including the use of Schedule II controlled substances if they are used appropriately and wisely and within appropriate professional practice standards. A medically justifiable purpose for treating a patient consists of affording treatment in a manner designed to relieve disease or distress or pain by whatever tests, diagnoses, evaluations or treatments can be performed in an acceptable manner within the confines of the professional medical practice standards of the community. Acceptable treatment is predicated on scientifically attempting to identify the pathology involved causing the distress, the anatomy and physiology affected and use of all evaluation and diagnostic tools in an effort to arrive at an opinion about what is wrong with the patient and what treatment is appropriate. It is medically justifiable for treatment to be performed solely for the purpose of relieving chronic moderate to severe pain in a patient, especially if all attempts are being made to alleviate the cause of that pain. The best person to make an informed interpretation concerning what is a medically justifiable treatment for a given patient is the treating physician himself at the time the treatment is applied. All three expert witnesses agreed that reasonable physicians can differ in the way they treat patients with similar conditions, and the Petitioner's expert, Dr. Handwerker, conceded that there is no single, established method of treatment for the conditions suffered by the patients named in the Administrative Complaint. Chronic pain patients are sometimes the most difficult to care for since pain is not a directly measurable disability. Some patients require a greater amount of pain medication to relieve a similar degree of pain than do other patients. In any event, the Schedule II controlled substances prescribed by Respondent are approved by the Federal Food and Drug Administration and the medical community for treatment of chronic, moderate to severe pain and are indicated as treatment for such in the Physician's Desk Reference relied upon as authoritative by all three experts in this case. It is appropriate and ethical to relieve a patient's pain with these drugs, even though the patient may have developed a tolerance or addiction to those substances. There is a concomitant obligation imposed by appropriate standards of medical practice to attempt to avoid or alleviate any addiction or tolerance that develops through efforts to wean the patients gradually off the narcotic substances, which Respondent consistently attempted in the case of each patient. Having reviewed all the treatment records and prescriptions used, Drs. Story and Brouillet also demonstrated that they were prescribed in the course of professional practice to the patients in question. Thee Respondent prescribed the drugs in a good faith effort to relieve pain while he was trying to determine and correct the underlying cause of each patient's distress. Dr. Van Ore's motivation in prescribing and treating as he did for these patients, was nothing other than an honest attempt to relieve their pain after his and others' efforts to alleviate the causes of pain had failed. Neither is there any evidence that Dr. Van Ore made any deceptive, untrue or fraudulent representations to his patients in the course of their treatment. He was open and honest with the patients and told them what he knew and believed concerning their chronic medical problems and the means he was using to try to alleviate them, including discussing with them the problem of drug addiction and attempting to convince them to reduce their use of Schedule II controlled substances. Dr. Van Ore had no ulterior purpose or motive in the treatment of these four patients, other than an honest attempt to alleviate their distress. Dr. Handwerker, testifying for the Petitioner, generally took the view that the Respondent's treatment of the four patients in question with controlled substances was for medically unjustifiable purposes and in inappropriate or excessive quantities. It is important to note that several prescriptions listed in the Amended Administrative Complaint attributable to Respondent were actually written by other physicians such as Dr. James Biggerstaff, Dr. James E. Lett, Dr. Charles Moller and Dr. Gwen Murray. Several were written for other patients who were not mentioned in the Amended Administrative Complaint and apparently several prescriptions had been altered by persons unknown. The testimony of Dr. Story raises questions concerning Dr. Handwerker's depth of understanding of these patients' medical histories when under the Respondent's care. For example, Dr. Handwerker apparently was unaware that the patients had been hospitalized and seen by various consultants, was also unaware of the various tests that each of the patients had been subjected to in the Respondent's and other specialists' efforts to learn the causes of their pain. In general, Dr. Handwerker was more concerned with the drug addiction or potential drug addiction of these patients, than with the fact that these patients suffered chronic pain which could not be relieved by any other means than Schedule II drugs. Dr. Handwerker's testimony being more tinged with his concern for drug addiction as a paramount consideration, not taking into adequate account the physician's concomitant obligation to alleviate suffering, nor taking into account Respondent's and other's exhaustive efforts to learn the causes of their suffering, renders the testimony and opinions of Drs. Story and Brouillet more credible and acceptable in their description of appropriate medical care and treatment under similar conditions and circumstances. The testimony of Dr. Handwerker, where it conflicts with these opinions, is rejected as less credible than those of Respondent's two experts. Count One raises the issues concerning the practice of physician's assistants Gary Chase and Denise Grant. Gary Chase began working for the Respondent as a licensed physician's assistant in September, 1980, and was certified as the Respondent's physician's assistant in October, 1980. He worked for the Respondent until June, 1983. The Respondent was his supervising physician. While Gary Chase worked as a physician's assistant for the Respondent, the Respondent was either physically present in the office or was within 20 minutes travel time from the office and was always available by electronic communication. The Respondent and Gary Chase would daily review all records of patients in which Gary Chase assisted in treatment and would always review any treatment Gary Chase had rendered no later than the next day. The Respondent furnished pre-signed blank prescription forms to Gary Chase. If a patient being seen by Chase needed a medication, Gary Chase would write out that medication, the amount needed, and record it in the patient's chart and use the pre-signed prescription form. The Respondent and Gary Chase would then review the patient's charts and prescription together when Chase next saw the Respondent on either the same day or no later than the next day. If a problem occurred with the prescription Chase had made or a treatment he recommended the patient, he or the Respondent would have called the patient that same day and changed the prescription. Chase does not recall such a problem ever occurring. With regard to the issue of Denise Grant's practice raised in Count One, there was no evidence to establish Denise Grant was a physician's assistant practicing under the direct supervision and control of the Respondent. There was no evidence that the Respondent had ever furnished prescription blanks to Denise Grant. Denise Grant was not called as a witness in this case. The Respondent has never been the subject of an investigation by the Department of Professional Regulation nor of disciplinary action, either formal or informal. The Respondent is an active member of the Asbury United Methodist Church in Maitland, Florida, and offers community service medical education programs on preventive medicine through the church. The Respondent has a reputation as a person of honest character and a reputation as a good and competent physician.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a final order be entered by the Board of Medical Examiners finding the Respondent, Steven Van Ore, guilty of a violation of Section 458.331(1)(aa), Florida Statutes, and that the penalty of a written reprimand be imposed. DONE and RECOMMENDED this 9th day of January, 1985 in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904)488-9675 FILED with the Clerk of the Division of Administrative Hearings this 10th day of January, 1985. COPIES FURNISHED: William M. Furlow, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ralph V. Hadley, III, Esquire Post Office Box 1340 Winter Garden, Florida 32787 Paul Watson Lambert, Esquire SLEPIN, SLEPIN, LAMBERT and WAAS 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Dir. Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
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 John D. Elder is a site worker at Port St. Lucie High School, having first been employed by the St. Lucie County School Board as a temporary employee in the summer of 1993. When first employed, Mr. Elder rejected the option to enroll in the employer's insurance plan. In September 1993, Mr. Elder was given an employer's insurance form allowing ninety days for enrollment. On November 12, 1993, he completed the form and became eligible for certain benefits on January 1, 1994. The St. Lucie County School Board Medical Benefit Plans, in which Mr. Elder enrolled, excludes coverge for pre-existing conditions until the end of 12 months of continuous coverage. The plans include the following definitions: A pre-existing condition is an injury, sickness or pregnancy or any condition related to that injury, sickness or pregnancy, where a diagnosis, treatment, medical advice or expense was incurred within twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include any injury, sickness or pregnancy or related condition that manifested itself twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include the existence of symptoms which would cause an ordinarily prudent person to seek diagnosis, care or treatment within twelve (12) months prior to the effective date of this coverage. (Emphasis Added.) From 1985 to 1988, Mr. Elder was treated by Dr. Urban who, on March 24, 1988, performed an electrocardiogram ("EKG"), which was normal. Dr. Urban treated Mr. Elder for respiratory illnesses, such as bronchitis and pleurisy, for back and shoulder muscle spasms, bursitis/tendonitis, and for high blood pressure. On September 21, 1988, Mr. Elder first saw Dr. Richard Dube. On that day, his heart rate was 62, as compared to the normal range of 60 to 100. In October 1988, Dr. Dube treated Mr. Elder for an inflammation of the muscle behind his shoulder. In December 1988 and January 1989, he treated Mr. Elder for high blood pressure and headaches. In July 1991, Mr. Elder called an ambulance and was taken to the hospital complaining of pain in his neck, across his shoulders, and down his arms. Among other tests, an EKG was performed. The diagnosis was tendonitis in his right shoulder. Later that same year, Mr. Elder complained of heart burn. Dr. Dube treated him for epigastric distress and high blood pressure. Blood test analyses of his cholesterol and high, low and very low density lipid levels indicated a cardiac risk factor of 10.3 for Mr. Elder, which is more than twice the standard male risk factor of 5.0. Dr. Dube ordered blood tests again in January 1993, at which time Mr. Elder's cholesterol and high density lipid levels were still high, but had decreased, reducing the cardiac risk factor to 8.0. Dr. Dube also referred Mr. Elder for an ultrasound of the gallbladder, which was diagnosed on January 29, 1993, as having calcification, which could represent a gallstone, and probably having a small polyp. At the same time he treated Mr. Elder for carpal tunnel syndrome and temporomandibular joint syndrome ("TMJ"). Most recently, on July 27, 1993, the same tests were repeated. With cholesterol in the normal range, the cardiac risk factor was decreased to 6.5. In the fall of 1993, Mr. Elder's complaints were diagnosed as episgastric reflux. To reassure Mr. Elder, Dr. Dube ordered another EKG, which was performed on November 23, 1993, and was normal. On January 3, 1994, Mr. Elder's complaints of ongoing pain caused Dr. Dube, who suspected he had a hiatal hernia, to refer him to Dr. Dan G. Jacobson for an upper endoscopy. Dr. Jacobson recorded a history of episgastric/chest pain, hypertension, ulcers and arthritis. Dr. Jacobson also noted a family history described as "remarkable for heart problems, heart attack." The admitting diagnosis was "history of episgastric pain refractory to medical therapy." Dr. Jacobson performed the endoscopy and diagnosed mild stomach gastritis. Based on a two week history of epigastric and chest pain, and his conclusion that the pain was too severe to result from the endoscopy findings, Dr. Jacobson consulted a cardiologist. Dr. Robert N. Blews, a cardiologist, saw Mr. Elder in the hospital. The history taken by Dr. Blews noted (1) that Mr. Elder's father died of a heart attack at age 68, and that his mother had coronary bypass surgery at age 48 and died at age 59, (2) that the onset of "chest tightness" was approximately one year prior, and (3) that he has a history of cervical spine disease. Dr. Blews' notes also reflected a change in the pattern of the chest pains in the last one to two months, and additional changes in the last two weeks. The longest episodes of pain were lasting from 20 to 30 minutes, with associated sweating and shortness of breath. Mr. Elder also told Dr. Blews that the pain could be with exercise, at rest, could awaken him, and occurred while he was just walking to his car. The report describes Mr. Elder as having a history of smoking. The EKG which Dr. Blews ordered on January 8, 1994 showed a major blockage on the left side of the heart, and is significantly different from all of the prior EKGs, including that taken on November 23, 1993. Dr. Blews concluded that Mr. Elder was having angina, or a decrease in the blood supply to his heart two weeks, two months, and a year before January 1994. Mr. Elder's wife, Florinda Elder, has been aware of his complaints of stomach problems for 10 years, but had no knowledge of his heart problems until January 1994. She was not aware of his having ever smoked or complained of shortness of breath. Although she was at the hospital, Mrs. Elder was not in the room when Dr. Blews took her husband's medical history. Mr. Elder's shoulder and muscle aches, and cervical spine pain are the result of a serious car accident in 1969. The pains are aggravated by cold weather. Mr. Elder claims to have been under the effects of anesthesia at the time Dr. Blews took his medical history, and denies having had a year of chest tightness, shortness of breath, or difficulty walking to his car. He has not smoked for 20-25 years, which is not inconsistent with Dr. Blews' report of a "history of smoking." Mr. Elder's attempt to undermine Dr. Blews history is specifically rejected. The McCreary Corporation is the administrator of the St. Lucie County School Board's self-insurance plan, which contracts with a consultant, Independent Health Watch. Kay Trentor, R.N., reviewed the claims submitted by Mr. Elder, and concluded that his coronary artery disease was a pre-existing condition. In part, Ms. Trentor was relying on Dr. Blews history of a year of "chest tightness." Mr. Elder's records were also sent for peer review, to two other consultant organizations, Professional Peer Review, Inc. and Medical Review Institute of America, Inc. They, in turn, sent the records to Board certified cardiologists, with cardiovascular disease subspecialties. The first report concludes that Mr. Elder "should have known that he had coronary disease because he had multiple risk factors for heart disease," and that "if he was reasonably prudent he would have had this taken care of during the time he was having chest pain walking to the car." The second peer review report also notes a year of chest tightness, with symptoms worsened "over the two months preceding the admission, but . . . not recognized as cardiac until the hospitalization on January 7, 1994." The report concludes that coronary artery disease was not diagnosed until after the effective date. The second report was prepared by Ronald Jenkins, M.D., who believes that Drs. Dube and Jacobson, "seemed to be focusing on gastrointestinal diagnoses . . . and had kind of missed the boat, so to speak . . .," but that "an ordinarily prudent person with John Elder's symptoms which he reported prior to January 1, 1994, [would] have sought medical treatment for those symptoms." Coronary artery disease takes years to develop, but is erratic in manifesting itself, with some people having no symptoms to severe symptoms over a matter of hours. Dr. Dube described it as "silent" coronary disease. Dr. Blews estimates that a heart attack is the first symptom in 40 percent of patients. There is no dispute that Mr. Elder has had other medical conditions, including TMJ, arthritis, and gastroenterological problems. Dr. Jenkins believes the most important manifestation of coronary artery disease was upper precordial chest tightness going to the left upper extremity as well as to the throat. When the history indicates that the tightness occurs with exercise, according to Dr. Jenkins that gives 90 percent confidence that it is anginal chest pain. That confidence level increases to 95 percent when he notes that Mr. Elder told Dr. Blews that chest discomfort occurs when he walks to his car. Without that history, however, Dr. Jenkins would not be able to conclude that the chest discomfort is due to heart disease or that the cardiac condition manifested itself prior to January 1, 1994. Dr. Jenkins described chest heaviness, aggravated by being in cold weather, as a symptom of coronary disease. The same pain without multiple risk factors, occuring irregularly, is a reason for "looking into other alternative diagnoses." Dr. Jenkins also acknowledges that episgastric reflux can cause chest discomfort and throat pain, and that cervical spine degenerative disc disease can cause a radiation of symptoms into the upper extremities, as it did when Mr. Elder called an ambulance in 1991. Dr. Blews did not have trouble getting a complete, detailed history from Mr. Elder. He typically has to elicit a more specific description from patients complaining of chest discomfort. He gives choices such as pain, burn, stab, jab, tight, squeeze or pressure, from which Mr. Elder chose "tight." Dr. Blews also found that Mr. Elder had chest wall pain in several spots or fibrosistitis, which is not a symptom of heart disease. Chest tightness could also be attributable to asthma, according to Dr. Blews, but with radiating pain into the left arm, jaw, and throat, shortness of breath, and sweating, he was certain Mr. Elder had heart disease. All of the doctors agree that Mr. Elder's heart disease existed before January 1, 1994, and that he had no diagnosis, treatment, medical advise or expense related to heart disease in the 12 months prior to January 7, 1994. There is no evidence that he was ever evasive or uncooperative with doctors. On the contrary, Mr. Elder was consistently described in doctor's notes and hospital records as anxious or concerned about his health. Coronary artery disease had not manifested itself to Mr. Elder or his doctors prior to Dr. Jacobson's decision to consult with Dr. Blews. "Manifest" is defined in Respondent's exhibit 9, a page from the International Classification of Diseases, 9th Revision, 1995, or ICD-9, as "characteristic signs or symptoms of an illness." The doctors who testified, in person or by deposition, described every sign or symptom experienced prior to Dr. Blews' consultation, as also being a sign or symptom of Mr. Elder's other medical conditions. Mr. Elder's symptoms might have been diagnosed as also indicating that he had heart disease, if he had been referred to a cardiologist sooner. There is no factual basis to conclude that Mr. Elder, or any ordinarily prudent person, should have sought diagnosis, care, or treatment for heart disease when, in fact, his doctor reassured him that his EKG was normal.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Respondent enter a Final Order approving Petitioner's claim for payment of medical expenses in the amount stipulated by the parties. DONE AND ENTERED this 12th day of July, 1995, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-0373 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Accepted in preliminary statement and Findings of Fact 2. Accepted in Findings of Fact 3. Subordinate to Findings of Fact 3. Accepted in Findings of Fact 22. Accepted in Findings of Fact 5-8. Accepted in Findings of Fact 5-8 and 12. Accepted in Findings of Fact 7 and 10. Accepted in Conclusions of Law. Accepted in or subordinate to Findings of Fact 6. Respondent's Proposed Findings of Fact. 1. Accepted in Findings of Fact 1 and 2. 2-3. Accepted in Findings of Fact 2. 4-5. Accepted in Findings of Fact 3. Accepted as corrected in Findings of Fact 23. Accepted in Findings of Fact 9. Accepted in Findings of Fact 8 and 9. 9-12. Accepted in or subordinate to Findings of Fact 9. 13-15. Accepted in Findings of Fact 20. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 20. Accepted in or subordinate to Findings of Fact 15-23. Accepted in preliminary statement and Findings of Fact 13. Accepted in or subordinate to Findings of Fact 14-16. Accepted in Findings of Fact 14 and 15. Accepted in Findings of Fact 16. Accepted in Findings of Fact 8. Accepted in Findings of Fact 9 and 20. Accepted in Findings of Fact 23. Accepted in Findings of Fact 17. Accepted in Findings of Fact 23. Accepted, but Dr. Dube's testimony was found credible and corroborated by his notes. COPIES FURNISHED: John T. Kennedy, Esquire The Injury Law Offices of John T. Kennedy 309 East Osceola Street Suite 306 Stuart, Florida 34994 C. Deborah Bain, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Lane, P.A. 1645 Palm Beach Lakes Boulevard Suite 700 Post Office Box 2508 West Palm Beach, Florida 33401 Frank T. Brogan Commissioner of Education The Capitol Tallahassee, Florida 32399-0400 Dr. David Mosme, Superintendent St. Lucie County School Board 2909 Delaware Avenue Ft. Pierce, Florida 34947-7299
