Findings Of Fact The Agency For Health Care Administration ("AHCA") is the state agency authorized to issue, revoke, or deny certificates of need ("CONs") for health care facilities and programs in Florida. AHCA published a numeric need for an additional adult open heart surgery ("OHS") program in AHCA District 1. District 1 is approximately 90 to 95 miles in length, from west to east, and includes Escambia, Santa Rosa, Okaloosa, and Walton Counties. Adjacent to Escambia County, north and further west, is the State of Alabama. Adjacent to Walton County and further east are (from north to south) Holmes, Washington, and Bay Counties, Florida, which are in AHCA District 2. The adult population of the District 1 is distributed so that 49 percent is in Escambia, 17 percent in Santa Rosa, 28 percent in Okaloosa, and 6 percent in Walton County. Fort Walton Beach Medical Center ("FWBMC"), in Fort Walton, Okaloosa County, and Baptist Hospital, Inc. ("Baptist"), in Pensacola, Escambia County, are competing applicants for an adult OHS CON. The parties stipulated to the need for one additional adult OHS program. Existing OHS Providers In AHCA District 1, Sacred Heart Hospital ("Sacred Heart") and West Florida Regional Medical Center ("West Florida") are the only two hospitals currently authorized to operate adult OHS programs, and both are located in Pensacola, Escambia County. There are also OHS programs adjacent to District 1, in District 2 and in Alabama. In 1991-1992, there were 507 OHS at West Florida, and 512 at Sacred Heart. Using the same quarters for the year for 1992-1993, OHS volumes declined to 447 at West Florida, and 408 at Sacred Heart. The following year (1993- 1994), volumes increased to 456 at West Florida, and 541 at Sacred Heart. The most recent data available from the local health council, for comparable quarters in 1994-1995, shows 483 procedures at West Florida and 743 at Sacred Heart, or a total of 1226. Using county-specific use rates and county-specific market shares, the total estimated number of OHS in District 1 facilities will be approximately 1275 in 1996, 1297 in 1997, and gradually rising to 1360 in the year 2000. Absent approval of any additional programs, Sacred Heart is projected to perform 764 procedures in 1996 and 811 in the year 2000, with West Florida Regional projected to perform 512 in 1996 and 550 in the year 2000. Sacred Heart Sacred Heart is a 391-bed not-for-profit hospital in Pensacola. The primary service area for Sacred Heart includes Escambia and Santa Rosa Counties. The secondary service area includes Okaloosa County, and Baldwin and Escambia Counties in Alabama. Sacred Heart is a disproportionate share provider. There has been an OHS program at Sacred Heart for over twenty years. Currently, three of the seven inpatient surgery operating rooms are used for OHS, with a heart- lung machine for each room. Sacred Heart also operates three cardiac catheterization ("cath") lab rooms, two primarily for caths and the third for electrophysiology studies. The designation of a third OHS operating room in March 1995, eliminated the need to schedule cardiac caths and angioplasties for limited, specific slots of time, by assuring the availability of an operating room for OHS back-up for patients who "crash" or need immediate OHS during a cardiac cath lab procedure. In 1993, a review of open heart surgery outcomes at Sacred Heart indicated higher than expected mortality rates. At that time mortality rates at Sacred Heart were statistically substantially above those at West Florida. When mortality rates were higher, the volume of OHS procedures at Sacred Heart was between 408 - 541, in contrast to current volumes in excess of 700 cases. Before 1993, two cardiovascular surgeons were on the Sacred Heart staff. Since the fall of 1993, two additional cardiovascular surgeons, affiliated with the Cardiology Consultants group, have been added to the staff at Sacred Heart, the more recent in the summer of 1994. Cardiology Consultants, a group of fifteen cardiologists, and its affiliate group of two cardiovascular surgeons, Cardiothoracic Surgery Associates of Northwest Florida, are the primary referral sources for 75 to 80 percent of OHS cases at Sacred Heart. The group operates the cardiology program at Sacred Heart. Cardiology Consultant's referrals for OHS are made to its two affiliated cardiovascular surgeons and to the two other cardiovascular surgeons, who are in a separate group. Cardiology Consultants has established an outreach program to smaller community hospitals. Two of the group's cardiologists conduct monthly case management conferences in Fort Walton Beach. They review, with local cardiologists, the treatment and subsequent care of patients previously referred to the group. In addition, cardiologists from the group have regularly scheduled consultation hours at hospitals in Atmore, Brewton, and Baldwin, Alabama. One member of Cardiology Consultants practices full-time in Foley, Alabama, where an 82-bed hospital is located. Although 100 percent utilization is unreasonable and impossible, Sacred Heart estimated that it had the capacity to perform 980 OHS a year and that the district had the capacity to perform 2,450 OHS a year, at a time when Sacred Heart had two cardiovascular surgeons and the district had five. Sacred Heart supports the approval of a new OHS program at Baptist, provided that Sacred Heart manages the entire program for the first two years and that a monitoring process assures adequate volumes to maintain the quality of care at Sacred Heart. West Florida Regional Medical Center West Florida, the only other OHS provider in District 1, is affiliated with the Columbia/HCA Health Care Corporation, as is the applicant, FWBMC. Until two years ago, West Florida served approximately 71 percent of OHS patients residing in Okaloosa and Walton Counties, as compared to 29 percent served at Sacred Heart. Sacred Heart, due to its and Cardiology Consultants' outreach, is gaining a greater share of the market. West Florida, FWBMC, and Gulf Coast Community Hospital, in Panama City, are three of five Columbia/HCA Health Care Corporation hospitals in what is called the Columbia North Gulf Coast Network. The other two are Twin Cities Hospital, with 75 beds in Niceville, and Andalusia Hospital in Andalusia, Alabama. The Gulf Coast Network negotiates managed care contracts and purchasing agreements on behalf of the five Columbia hospitals in the area. In District 1, Columbia also owned a hospital in Destin, which is now closed. Bay Medical Center Bay Medical Center is an independent, tax-exempt special district, authorized by the Florida Legislature in July, 1995, to operate an existing public hospital, and to meet the health care needs of residents of Panama City and the surrounding areas. Panama City is in Bay County, which is in AHCA District 2, immediately adjacent to southern Walton County. The hospital has 353 licensed beds and is located approximately 2 miles from Gulf Coast Community Hospital. Bay Medical has approximately $43 million in long-term debt financed through tax-exempt revenue bonds. Bay Medical provides cardiac cath, open heart surgery and angioplasty, obstetrics, and inpatient psychiatric services. As a full-service regional tertiary hospital, Bay Medical also has renal dialysis, neurosciences, a hyperbaric chamber, and radiation oncology. Approximately 97 percent of all indigent care services rendered in Bay County are provided by Bay Medical. Under a certificate of convenience from Bay County, Bay Medical operates an advanced life support transportation system for intra-hospital transfers. The transportation system received a subsidy of approximately $450,000 in 1994, having not reached sufficient volume to break even. The staff at Bay Medical includes seven cardiologists and four cardiovascular surgeons. For the fiscal year ending September 30, 1995, 329 OHS cases and 2,447 caths (including 469 angioplasties) were performed at Bay Medical. In 1994, two OHS cases at Bay Medical originated in Okaloosa and Walton Counties, one from Point Washington and one from Crestview. Until the 1995 legislation establishing the special district, Bay Medical Center was limited to doing business in Bay County. Bay Medical is now authorized to establish business entities or satellite clinics in neighboring southern Walton and Okaloosa Counties, including the beach communities located between Panama City and the Destin/Sandestin area. Destin is approximately 45 miles and Fort Walton is approximately 65 miles from Bay Medical. With its existing OHS operating room and an additional one that was scheduled to be equipped for OHS in November 1995, Bay Medical has the capacity to double the 329 OHS cases and to accommodate an additional 300 angioplasties. Alabama Hospitals Three OHS programs exist in Mobile, Alabama, within 45 miles of Pensacola, but few referrals are made from District 1 to the Mobile hospitals. When out-migration to Alabama occurs, the relatively few cases go either to a large university teaching hospital or to a veterans administration hospital, both in Birmingham. Con Applicants Baptist Hospital Baptist is licensed to operate 601 beds, and 541 of those beds are located in Baptist Hospital ("Baptist"), Pensacola. The other 60 beds are located at Gulf Breeze Hospital, approximately 10 miles southeast of Pensacola in Santa Rosa County. The licenses for the two facilities were combined into a single license in April 1995. Baptist Hospital is a major acute care hospital and tertiary referral center, with an active oncology program providing infusion services, chemotherapy, and radiation therapy, and a wide range of psychiatric and substance abuse services. It is accredited by the Joint Commission for Accreditation of Health Care Organizations (JCAHO). Baptist is a state-designated trauma center. Emergency ambulance transportation and life flight, covering northwest Florida and southwest Alabama, are provided by Baptist, consistent with its extensive outreach to physicians, clinics, and to a 55-bed Baptist Health Care hospital located in the town of Jay in Santa Rosa County. Baptist is a disproportionate share provider under the state Medicaid and the federal Medicare programs. In District 1, Baptist provided care to the largest number of patients with AIDS for 1993 and 1994. Baptist offered to condition its CON-approval on providing 1.8 percent of total OHS to Medicaid patients and .9 percent to charity. Baptist has a sophisticated cardiology program, providing a wide range of non-invasive, as well as diagnostic and therapeutic services, including inpatient and outpatient cardiac caths, echocardiography, and electrophysiology. Baptist was the first hospital in District 1 to offer electrophysiology, beginning in 1983. Baptist also offered angioplasty services before they were regulated. The general term "angioplasty" includes traditional coronary balloon angioplasty, arthrectomies, and stents. In traditional balloon or percutaneous transluminal coronary angioplasty ("PTCA"), an obstruction in an artery is opened by inflating a balloon-type device at the end of the catheter. As a grandfathered provider, Baptist continues to provide emergency angioplasties, which are typically performed on patients presenting to an emergency room with evidence of acute myocardial infarction (heart attack). Approximately 70 emergency angioplasties were performed at Baptist in 1995. In the year ending in June 1995, there were approximately 990 diagnostic cardiac caths at Baptist. One fourth to one third of all cardiac caths result in a finding that a follow- up interventional procedure is needed. Cardiology Consultants also operate the cardiology program at Baptist, as a part of the Sacred Heart program. The unified Baptist/Sacred Heart cardiology department has a common medical staff, a single section chief, joint peer review, and shared on-call teams. Baptist/Sacred Heart cardiologists also staff Baptist's Jay affiliate and four smaller hospitals in Alabama. Services available through the outreach program include computerized EKG interpretation, multi-monitor scanning, and mobile cardiovascular ultrasound services. Baptist and Sacred Heart have licenses for cardiovascular information systems software, with common data elements, and report formats. If approved, Baptist would implement OHS services with quality assurance, case management, and other protocols used at Sacred Heart. The two hospitals' surgical team members will cross-train and eventually have the ability to operate at either facility with any of the cardiovascular surgeons on staff. Baptist has approval from an affiliate of Sacred Heart, the Daughters of Charity National Health System, to access its national cardiac database. Cardiology Consultants would recruit an additional cardiovascular surgeon for the Baptist OHS program. Baptist proposes to renovate approximately 5700 square feet and to use two existing operating rooms in the surgical suite in the Pensacola hospital for OHS. Between the two operating rooms, an area which currently is a cystoscopy room would be used for perfusion services. Baptist proposes to add two beds to the 8-bed coronary ICU unit located on the first floor, adjacent to the operating rooms. A progressive care unit on the fourth floor will also serve OHS patients. Baptist's proposal was criticized as a response to an institutional desire to complete the range of cardiac services available at Baptist, not a response to a community need for the service. Baptist was also criticized for its potential adverse impact on the OHS program at Sacred Heart, although Sacred Heart supports Baptist's proposal. Baptist's proposal relies on Sacred Heart for management services and Cardiology Consultants for volume monitoring. The only document stating the proposed terms of an agreement with Sacred Heart is a letter of May 1, 1995, from Sacred Heart's President and CEO. The letter requested written confirmation of the ground rules by Baptist, which has not been done. The State Agency Action Report, which gives the reasons for AHCA's preliminary approval of the Baptist application, includes a reviewer's statement that "Concern is raised regarding control and responsibility for the proposed open heart surgery program between the parties of the 'cooperative arrangement'. At the final hearing, AHCA's expert testified that she was not concerned about the details of the proposed agreement because it cannot affect the OHS program negatively. Fort Walton Beach Medical Center FWBMC is a 247-bed hospital, with 170 medical/surgical beds, averaging 52 percent occupancy, or approximately 128 patients. A 20-bed comprehensive medical rehabilitation unit and an 18-bed skilled nursing unit are CON-approved and under construction at FWBMC. Comprehensive rehabilitation services were scheduled to begin in February, 1996, and skilled nursing in the Spring of 1996. FWBMC has received, with its accreditation, letters of commendation from the JCAHO. FWBMC is located 45 miles from the Gulf of Mexico in the center (from east to west) of Okaloosa County. The primary service area for FWBMC is Okaloosa County and the southern fringes of Santa Rosa and Walton Counties. The communities of Fort Walton Beach, including Eglin Air Force Base, Niceville, and Valparaiso, Santa Rosa Beach, Sandestin, Destin, Navarre Beach, Crestview, and DeFuniak Springs are in the service area. FWBMC does not include Bay County, which is southeast of Walton, in its service area. Okaloosa County has a population of 157,000, which is growing, in part, by attracting retirees, including retired military personnel. Eglin Air Force Base is located on 724 square miles of federally owned land in the County. The Base hospital, located approximately 8 miles northeast of FWBMC, is a regional facility for approximately 20,000 active and 30,000 retired military personnel. Eglin Hospital operates 80 of its 155 beds and is a basic medical/surgical hospital, with small psychiatric and obstetrics units. Eglin provides significant outpatient clinic care. Eglin Hospital does not have OHS or cardiac cath. When a service is not available at Eglin Hospital, the patient receives a non-availability statement authorizing the patient to receive that specific service at another hospital. Eglin patients are most often referred to FWBMC for neurosurgery, psychiatric care, intensive care, coronary care and cardiac caths, and, when Eglin's capacity is exceeded, for obstetrical care. OHS cases from Eglin are referred to the two Pensacola providers. In addition to FWBMC and Twin Cities, other hospitals in Okaloosa County are North Okaloosa Medical Center, with 115 beds, and Harbor Oaks, a psychiatric adolescent hospital. In Walton County, there is one hospital, Walton Regional in DeFuniak Springs. Currently, at FWBMC, non-interventional diagnostic procedures include nuclear stress testing, and echocardiography, which is a type of ultrasound. Although transesophageal echocardiography, in which the patient swallows a probe that touches the back of the heart, gives far better resolution and a clearer picture of the heart, FWBMC has been unable to justify the maintenance of the probe due to low volumes of the procedure. Five cardiologists are on staff at FWBMC. Two of them also work at North Okaloosa Medical Center, four of the five also see patients at Twin Cities Hospital in Niceville. The cardiologists performed approximately 700 cardiac cath lab procedures in 1995. Rule 59C-1.032(6)(a), Florida Administrative Code, requires cardiac cath labs to have written protocols for the transfer of patients by emergency vehicle to a hospital with OHS within 30 minutes average travel time. Emergency heart attack patients benefit most from having angioplasties within two hours of the onset of symptoms. In reality, however, the experience at FWBMC is that preparing the patient for transfer, waiting for the helicopter or ambulance, exchanging information between transferring hospital staff and transport personnel, and between transport personnel and receiving hospital staff, and actual travel time can take up to two and a half hours. The only interventional cardiologist in Okaloosa County performed 28 PTCAs at West Florida in Pensacola, in 1994. American College of Cardiology and American Heart Association ("ACC/AHA") guidelines set an annual minimum of 75 therapeutic cath procedures for interventional cardiologists. The application and the testimony were in conflict on the issue of whether one or two cardiovascular surgeons would perform OHS at FWBMC when the program opens. Initially, case volumes would support only one cardiovascular surgeon, but at least two are needed to provide 24 hour coverage. Although Fort Walton's administrator testified that there would be two cardiovascular surgeons at some point, the application describes the need to recruit a surgical team consisting of one surgeon. FWBMC plans to construct an operating room, dedicated to OHS, to renovate an adjacent operating room for OHS, and a middle room as a pump room, and to purchase the equipment necessary for the OHS program. The program protocols will be developed using the experiences of other Columbia affiliates, including West Florida, Miami Heart Institute, and Bayonet Point Hospital in Hudson, Florida. The staff at FWBMC has the ability to apply an intra-aortic balloon pump assist. FWBMC also has an established thrombolytic protocol, and a team to evaluate the outcomes of patients with cardiovascular disease. Approximately 10 nurses at FWBMC have a minimum of three years experience with OHS critical care. Within the past two years, four nurses have been hired by FWBMC directly from OHS programs. The majority of ICU and CCU nurses are certified in cardiac life support. As a Columbia facility, FWBMC also has on-line access to other Columbia affiliates information systems, including other hospitals' policies, protocols, and volumes, and would utilize Columbia's resources for training and refresher courses for staff. FWBMC is committed to providing three percent of OHS services for Medicaid and two percent for indigent patients. FWBMC also commits, as a condition for CON approval, to having charges set at 85 percent of the maximum allowable rate increase (MARI) adjusted average for existing providers' OHS charge. FWBMC's proposal was criticized as being unable to attract the volumes projected, the cardiovascular surgeons needed for 24 hour coverage, or to provide OHS at the cost proposed. FWBMC was also criticized for the potential adverse impact on the OHS programs at Bay Medical Center and West Florida. Statutory Review Criteria Section 408.035(1)(a)-need for the service in relation to local and state health plan The parties agree that the 1994 District One Health Plan Certificate of Need Allocation Factors to apply the review of their CON applications. The District 1 health plan gives a preference to a CON applicant that best demonstrates cost efficiency, lower project costs, and lower patient charges. Baptist's total project costs are $1.58 million, FWBMC's are $2.2 million. Baptist's project is confined to the renovation of 5,700 square feet of existing space, as compared to FWBMC's combined renovation of 1,100 square feet and new construction of 1,600 square feet. FWBMC commits, as a condition for the award of its CON, to set OHS charges at not more than 85 percent of the MARI, adjusted district average. In the application, FWBMC further explains that its proposed fixed rate structure will not exceed 85 percent of the adjusted district average for existing district providers' DRG charges, using a six percent annual inflation rate. Using 1994 data for the World Health Organization's classification of Major Diagnostic Category-5 ("MDC-5"), a grouping of cardiovascular diseases, excluding OHS, Baptist demonstrated that charges per discharge were highest at FWBMC, followed in order by Baptist, West Florida, and Sacred Heart. Outside the district, Bay Medical's cardiology rates were approximately 16 percent lower than those at FWBMC. Baptist's expert concluded, therefore, that FWBMC's second pro forma year open heart revenue per case would be $75,314 per case, not $47,534 as projected in the CON application. By comparison the same methodology shows MDC-5 revenues per admission at West Florida and Baptist varying by only two percent. Baptist's second pro forma year revenue per case, using the same methodology, is $60,268, as compared to its CON projection of $61,441. Revenues per case for two different categories of inpatient cardiac caths, for the 12 months ending December 31, 1994, were $13,721 at FWBMC and $10,901 at Baptist in one category, and $11,219 at FWBMC and $9,186 at Baptist in the other. Baptist also contends that charge master items, including procedures, ancillaries, and tests which are common to other MDC-5 categories cannot realistically be billed at a different rate when related to OHS. FWBMC asserts that its commitment to lower charges can be accomplished by adjusting the charge master for "big ticket" items included in OHS cases, such as the use of the OHS operating rooms or the daily charge for cardiovascular intensive care beds. Baptist's assertion that FWBMC cannot set charges to meet the commitment is rejected in view of a similar commitment having been offered by Baptist in a prior application, and the apparent implementation of a similar pricing formula at another Columbia facility, Tallahassee Community Hospital ("TCH"). Beyond stating that "big ticket" item pricing could be used, FWBMC, however, failed to explain any details for implementing charges in this case, in view of its higher MDC-5 charges, and its existing requests for amendments to the MARI. There was no evidence that the charge structure is comparable to that which existed at TCH, although a former TCH administrator now works at FWBMC. Assuming arguendo that FWBMC can discount OHS charges by 15 percent, FWBMC concedes that lower patient charges will benefit directly only the payor groups which have reimbursement formulas related to actual charges. The direct benefit affects not more than 38 percent of the patients who are in a payor category which is declining with the rise in managed care. Indirectly, FWBMC noted, charges can be a starting point for negotiating managed care rates. FWBMC's lack of specificity on how it would set charges despite its higher MDC-5 charges, its limited benefit to patients due to shifts in payor mix, and the fact that an affiliate hospital is setting charges used to calculate the district average diminish the importance of the FWBMC pricing proposal as a community benefit in an OHS program. In addition, AHCA's expert noted, 1992 data indicated "that District 1 had on the whole lower average charges for OHS than the state." In general, the Baptist application better meets the first preference of the local health plan. Based on Baptist's failure to address local health plan preference 2 in its CON application, and FWBMC's statement that the preference, related to the conversion of beds, is inapplicable, the preference is deemed inapplicable or not at issue. Preference three for CON applications to convert existing capacity to expand existing or new services over CON applications seeking new construction, is better met by Baptist. FWBMC will construct an additional 1670 square feet and renovate 1100 square feet, and Baptist will renovate 5700 square feet of existing space. Preference four, favoring joint ventures and shared services that mutually increase existing resource efficiency over unilateral CON applications, is of limited value in distinguishing between the applications of Baptist and FWBMC, because both are unilateral applications. Through the influence of Cardiology Consultants, more shared cardiology services currently exist between Baptist and Sacred Heart, and could continue for at least two years, subject to the terms of an proposed agreement which has not been negotiated or accepted by the Boards of Directors of the hospitals. West Florida and FWBMC also have the potential for cooperation due to their common ownership. Although AHCA's initial reviewer gave Baptist full credit for meeting the preference, AHCA's expert testified at hearing that she would not have given Baptist that credit. Financial access is the concern embodied in preference five, for CON applicants demonstrating a commitment to the provision of services regardless of the ability of patients to pay; preference six, for CON applications specifying the greatest percentage of services to Medicaid and indigent patients; and preference seven, for applicants with the best history of Medicaid and indigent service. The preferences do not necessarily apply solely to assure the availability of OHS to Medicaid and indigent patients, most of whom are children or women below the age of 65, who are less likely to need OHS than older persons. In District 1, for example, an annual average of 2.8 percent of OHS patients are covered by Medicaid. One health planning expert described the preferences as rewarding a provider of charity services with an off-setting potentially profitable service, as demonstrated by the applicants' pro formas, although the trend towards managed care is limiting the ability of hospitals to do such "cost sharing". See, also, Subsection 408.035(1)(n), Florida Statutes. Baptist is a disproportionate share Medicaid provider, FWBMC is not. FWBMC noted that it has served more patients in the self-pay category, which includes most uninsured patients who are ultimately categorized as bad debt or charity. In 1994, self-pay at Baptist was 5.85 percent and 9.98 percent at FWBMC. At FWBMC, Medicaid was approximately 12 percent, and charity care was approximately 1.7 percent of the total in 1994. By contrast, in 1994, Baptist's Medicaid patient days were 17 percent of its total, or 19 percent when Medicaid health maintenance organizations ("HMOs") are included. At the same time, charity care was 3.8 percent of the total at Baptist. Baptist proposes to serve four Medicaid and six self-pay patients of the total number of 175 patients in year one, and four Medicaid and seven self- pay of the 227 patients in year two. FWBMC proposes to serve three percent Medicaid and two percent indigent of its projected total of 203 patients in year one, and of 221 patients in year two. Although the Baptist and FWBMC commitments are comparable in terms of combined total number of Medicaid and indigent patients, Baptist better meets the financial access preferences due to its commitment, combined with its history and status as a disproportionate share Medicaid provider. Local health plan preferences which are inapplicable to or fail to distinguish between the CONs at issue are: 8, for bed expansions; 9, on bed distribution; 10 and 11, on bed occupancy rates; 12, related to subdistrict case loads; 13, for facility occupancy rate projections; 14, for pediatric unit conversion; 15, for ICU/CCU conversions; 16, 17, 18, 19, and 20, related to technology and major equipment applications. Local health plan preference 21, for applicants demonstrating a history and willingness to serve AIDS patients, is met by both Baptist and FWBMC. Baptist served more HIV+/AIDS patients in 1994, having admitted 88 people with illnesses classified in the DRGs related to AIDS, for 808 of its total of 88,423 patient days. At the same time, FWBMC admitted 14 patients in the same DRGs for 185 of its total of 35,648 patient days. Mortality rates for AIDS, as an indicator of the incidence of HIV and AIDS, are considerably lower in Okaloosa than in Escambia County. Baptist meets preference 22, as the District 1 hospital which has provided the greatest percentage of patient days to AIDS patients. The first state health plan preference supports the establishment of OHS programs in larger counties within a district where the percentage of elderly is higher than the statewide average and the total population exceeds 100,000. Although the populations of both Escambia and Okaloosa Counties exceed 100,000, neither exceeds the statewide average percentage of elderly (defined as residents age 65 and older). Escambia County had approximately 275,000 residents, compared to approximately 157,000 in Okaloosa County. The statewide percentage of the population 65 and over was 18.6 percent in 1995, but only 12 percent in Escambia, and 10 percent in Okaloosa. The second state preference is given for new OHS programs clearly demonstrating an ability to perform more than 350 OHS procedures annually within three years of initiating the program. There is a direct relationship between higher volumes of cases and better outcomes in OHS. Using a New York study, the ACC/AHA guidelines for cardiovascular surgeons set a minimum of 100 to 150 OHS cases a year in which the surgeon performs as the primary surgeon, and an institutional minimum of 200 to 300 cases for each OHS program. The institutional minimum set by AHCA for OHS programs in Florida is 350 OHS cases a year. Baptist projects that 175 OHS and 239 PTCAs will be performed at Baptist Hospital in the first year of operation, and 227 OHS and 243 PTCAs in the second year. The actual number of direct Baptist patient transfers (from bed to bed, without an interim discharge) for OHS was 116 in 1993, 129 in 1994, and 88 in the first 9 months of 1995. Because Baptist would be keeping most of the existing transfers and splitting the existing and growing Sacred Heart volume of over 800 cases projected by the year 2000, performed by the same cardiovascular surgeons who have the ability to re-direct up to 75 to 80 percent of that volume, Baptist demonstrated that it has the ability to reach 350 procedures within three years. Most of the OHS performed at FWBMC would, in the absence of a FWBMC OHS program, be performed at West Florida. FWBMC projects that it will reach volumes of 203 OHS and 215 PTCAs in 1997, and 221 OHS and 234 PTCAs in 1998. The projections assume that FWBMC will be able to capture 76 percent of the OHS patients residing in Okaloosa and Walton Counties in year one and 80 percent in year two, which is the historical market share for West Florida. FWBMC would expect to keep most of its current acute transfer (bed-to-bed) patients for OHS or angioplasties, of which there were 167 in 1994, and 200 in the first 8 months of 1995. In addition, FWBMC expects to have an additional five percent in- migration, which appears to be a conservative estimate when compared to the current twelve to fourteen percent in-migration to District 1 for cardiac cath services, and twenty to twenty-five percent in-migration for OHS. The current in-migration is, however, to Pensacola not to Okaloosa County. In less than a year, from 1994 to the first ten months of 1995, Sacred Heart, as a result of its and Cardiology Consultants' out-reach programs, more than doubled its referrals from Fort Walton Beach, shifting referrals away from West Florida. The underlying assumption that FWBMC can attract over 75 percent of the Okaloosa/Walton resident market in year one and 80 percent in year two, based on West Florida's historical market, is rejected as not supported by the evidence. Although both FWBMC and West Florida are Columbia facilities, the new program at FWBMC will have no track record, will admittedly continue to transfer more complex cases, has not yet identified cardiovascular surgeons and, therefore, has no OHS referral relationships with cardiologists and primary care physicians in the district. Baptist estimates that FWBMC reasonably can expect to perform between a third and a half of the OHS from Okaloosa/Walton residents, resulting in 108 to 164 OHS in 1997, 110 to 167 in 1998. FWBMC did not demonstrate that it can reach 350 OHS cases within three years of initiating the program. State health plan preference three for improved access to OHS for persons currently seeking services outside the district is not a significant factor in distinguishing between the applicants, due to the relatively small out-migration experienced in District 1. More out-migration does occur from Walton and Okaloosa than from Escambia and Santa Rosa Counties, which supports FWBMC's claim that its location better enhances accessibility within the district. Preference four, for a hospital which meets the Medicaid disproportionate share criteria, and provides charity care, and otherwise serves patients regardless of their ability to pay, favors the Baptist application. Preferencefive applies to an applicant that can offer the service at the least expense, while maintaining high quality of care standards. The health plan preference further suggests that the physical plant of larger facilities can usually accommodate the required operating and recovery room specifications with lower capital expenditures than smaller facilities, and that the larger hospital generally has the greater pool of specialized personnel. FWBMC presented evidence that other hospitals its size, for example Columbia-affiliate Bayonet Point in Hudson, Florida, operate successful OHS programs. Nevertheless, Baptist is entitled to the preference based on its size, renovation plans, project costs, and existing depth of specialized and tertiary services. Preference six, favors hospitals with protocols for the use of innovative techniques as alternatives to OHS, such as PTCA and streptokinase therapy. Baptist, as a grandfathered provider and by virtue of protocols approved by AHCA does provide PTCA. Both Baptist and FWBMC offer streptokinase and other alternative thrombolytic therapies. FWBMC will be able to expand cardiac cath lab services to include PTCA, if approved for OHS. Beyond PTCA, the application and testimony do not indicate the scope of angioplasty procedures proposed by FWBMC. On balance, Baptist's application better meets the need for an additional adult OHS program in relation to the applicable local and state health plans. Section 408.035(1)(b) - availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the district; (1)(b) - accessibility to all district residents; (2)(b) - appropriate and efficient use of existing inpatient facilities, and (2)(d) - serious problems in obtaining inpatient care without the proposed service. AHCA has established, by rule, that OHS is a tertiary service not intended to be available necessarily at every qualified hospital. Rule 59C- 1.033(4)(a), Florida Administrative Code, sets the objective of having OHS available to at least 90 percent of the population of each district within a maximum two hour drive under average travel conditions. With the existing providers in District 1, the access standard is met. Because the geographic access standard of the rule is met in District 1, Baptist's expert asserts that geographic access is relatively insignificant in distinguishing between the applications in this case. That position is rejected as inconsistent with the statute. Although transfers are inherent in the concept of tertiary services, enhancing access to decrease transfers and the distance and time required for transfers is a valid basis for distinguishing between competing applicants. AHCA's expert testified that "assuming that everything else is equal, then . . . avoid[ing] more transfers . . . could be important." Using weighted average travel times for residents, based on the 1995 adult (15 and over) population, Okaloosa County residents are 62.35 minutes from the closer of the two existing district OHS providers. That would be reduced to 17.42 minutes if an OHS program is established at FWBMC. Walton County residents' average travel times would decrease from 79.7 minutes to 47.89 minutes with a program at FWBMC. For Santa Rosa residents, the improvement would be approximately one and a half minutes, from 25.85 to 24.43 minutes. If Baptist's application were approved, the travel time for Escambia County residents would improve from 15.8 to 11.17 minutes. Currently, 75 percent of district residents are within an hour of an OHS program. The establishment of a program at FWBMC would improve geographic access by increasing to 98 percent the number of district residents within one hour of an OHS program. The establishment of an OHS program at FWBMC also will assist in alleviating the current mal-distribution of cardiac resources. The program would attract more interventional cardiologists to the eastern areas of district, where there currently is one, and would attract cardiovascular surgeons, where there are none. County OHS use rates varied in 1994, from 1.72 discharges per thousand population in Okaloosa County to 2.12 in Escambia. Angioplasty use rates were 1.84 for Escambia and 1.55 for Okaloosa residents. The difference is attributable to the relative accessibility of OHS in Escambia, the population difference of more people over 65 in Escambia, and the availability of fifteen cardiologists at Baptist and Sacred Heart, as compared to five at FWBMC. There is no evidence of inefficiency or quality of care concerns at the existing providers, after the decline in 1993 mortality rates at Sacred Heart. The extent of utilization of the existing providers and the evidence regarding capacity demonstrates that available OHS capacity exists in District 1, and will continue to exist through the year 2000, based on all of the parties' projections. Due the overlap in medical staff, referral sources, market shares, and physical proximity, the approval of a new program at Baptist is reasonably expected to have the greatest adverse impact on the volume of OHS performed at Sacred Heart. For the year ending in September 1995, approximately 564 cases were referred to Sacred Heart by Cardiology Consultants, 91 by Gulf Coast Cardiology, 44 by Fort Walton Beach Cardiology Group, and another 44 from various other sources. Using Baptist's current 43.8 percent share of the combined Baptist/Sacred Heart MDC-5 market, and the projected total volumes, Baptist would have 339 of the combined 776 OHS in 1997, and 355 of 811 in 2000. The remaining cases would leave Sacred Heart at or below 1993 levels, when its mortality rates were statistically significantly higher than those at West Florida, although there is no evidence that volume was the cause of the 1993 mortality rates. Sacred Heart witnesses testified that they assume that the minimum volume assured for Sacred Heart would be 350 cases, as referenced in the OHS rule, but the Baptist/Sacred Heart agreement has not been negotiated. Any minimum volume agreement is also directly dependent on Cardiology Consultants' ability to retain their share of the OHS market and their ability to allocate cases between the two hospitals. Baptist emphasized that the programs at Baptist and Sacred Heart ultimately will become competitors. The establishment of an OHS program at FWBMC, Baptist asserts, will reduce OHS volume at West Florida below 350, and will redirect OHS patients from Bay Medical Center in Panama City, which has not reached the 350 minimum. The projected volume of OHS at Bay Medical was 332 procedures in 1995. The loss of Bay Medical cases, according to Baptist's expert, will occur because Columbia facilities, including Gulf Coast Community Hospital in Panama City, will refer patients to FWBMC. Baptist's expert relied on 1994-1995 (third quarter) data which demonstrated that more referrals were made to West Florida than to Bay Medical in some areas of District 1 which are closer to Bay Medical. However, the total number of Bay County residents receiving OHS in District 1 was nine, three at Sacred Heart and six at West Florida. Virtually no overlap exists between the service areas of Bay Medical and FWBMC, while substantial staff overlap exists between Bay Medical and Gulf Coast. All eight cardiologists on the staff of Gulf Coast are also on the staff of Bay Medical. It is not reasonable to conclude that the cardiologists will make referrals for OHS to more distant hospitals where they have no staff privileges. FWBMC projects that one quarter of one percent of its discharges will come from Bay County. In 1994, there were 3 OHS cases at Bay Medical from Okaloosa and Walton Counties. Baptist's assertions that referral patterns in Districts 1 and 2 are dictated by the presence of Columbia facilities in various communities, and that Bay Medical would be affected adversely by the establishment of an OHS program at FWBMC are rejected as not supported by the evidence. An OHS program at FWBMC will reduce the volume of OHS cases at West Florida. Using FWBMC's estimates that it will have 203 OHS in 1997 and 221 in 1998, retaining many patients who would have required transfers to Sacred Heart and West Florida, with five percent in-migration, and assuming that the volume ranges from 483 to 550 cases at West Florida, then West Florida can remain marginally above 350 cases. The remaining volume is inadequate to provide the minimum 100 to 150 OHS for each of the four cardiovascular surgeons, to assure a high quality program without reducing the number of surgeons. Section 408.035(1)(c) - applicant's quality of care Both Baptist and FWBMC provide high quality of care in existing programs, as reflected, in part, by their JCAHO accreditations. Baptist's application better documents its ability to establish a high quality OHS program, to the detriment of that at Sacred Heart. FWBMC does not document its ability to establish a quality OHS program, due to its size, relative lack of tertiary programs, lack of some supplementary diagnostic and therapeutic cardiac services, and failure to identify cardiovascular surgeons and interventional cardiologists who will perform OHS and angioplasties at FWBMC. Section 408.035(1)(d) - availability of alternatives to inpatient care There are no alternatives to inpatient angioplasty and OHS care. Section 408.035(1)(e) - economics of joint, cooperative and shared health care resources Baptist would benefit from duplicating the program at Sacred Heart and, presumably, from Sacred Heart's clinical management of the Baptist program for the first two years. The precise nature of Sacred Heart's contribution to the Baptist program is subject to the terms of an agreement which has not been negotiated and, therefore, is impossible to evaluate. FWBMC would also benefit from the experiences of other Columbia affiliates which are OHS providers. Although both applicants address quality of care benefits of cooperation, neither demonstrates any economic benefit. Section 408.035(1)(f) - district need for special equipment or services not accessible in adjoining areas Baptist and FWBMC are proposing to provide equipment and services which are already available in District 1 and the adjoining areas. Section 408.035(1)(g) - need for medical research and educational and training programs; and (1)(h) - use for clinical training and by schools for health professionals Neither Baptist nor FWBMC proposed to meet a need for research, educational, or training programs. Section 408.035(1)(h) - availability of personnel and funds The parties stipulated that each applicant has the ability and means to fund the accomplishment and implementation of their projects. The parties also stipulated that proposed non-physician staffing is available and that staffing levels, salaries, and benefits are reasonable. FWBMC's physician recruitment proposals are unclear and too incomplete to conclude that it can adequately support an OHS and angioplasty program. Section 408.035(1)(i) - immediate and long-term financial feasibility The parties stipulated that each proposal is financially feasible in the immediate and long term if the volume projections are proven. Baptist's volume projections are supported by the evidence that the OHS and angioplasty cases can be shifted from Sacred Heart to Baptist. FWBMC failed to show that it can achieve projected volumes by similarly shifting cases from West Florida due to distance, the absence of overlapping cardiology staff, increased competition from Sacred Heart, and the need to continue to refer complex cases to more established programs. Therefore, FWBMC's proposed OHS program is not found financially feasible in the long term. Section 408.035(1)(j) - special needs of health maintenance organizations (HMOs) Neither Baptist nor FWBMC proposes to meet the special needs of HMOs. Section 408.035(1)(k) - needs of entities which provide substantial services to individuals not residing in the service district Neither applicant asserted at hearing that its proposal is based on the provision of substantial services to non-residents. The parties did demonstrate that over 20 percent of OHS are performed on non-residents, many from surrounding areas in Alabama. Section 408.035(1)(l) - cost-effectiveness, innovative financing, and competition FWBMC proposed an innovative system for charging for OHS services. The explanation of how one affiliate hospital implemented the alternative charging system and how FWBMC would do so was, however, incomplete and inadequate, when compared to evidence of its existing high costs for cardiology services and limited payor group benefit. Section 408.035(1)(m) - construction costs and methods The parties stipulated that the project costs, schedules, and architectural designs are established and reasonable. Section 408.035(1)(o) - multi-level continuum of care The parent corporations of both applicants include clinics, nursing homes, as well as other acute care facilities within their organizations. Section 408.035(2)(a) - less costly, more efficient alternatives studied and found not practicable; and 2(c) alternatives to new construction considered The utilization of OHS and angioplasty programs at existing providers when compared to their available capacity, and the direct correlation between higher volumes and higher quality, indicate that the least costly, most efficient practicable alternative is to rely on existing providers to meet the need for OHS and angioplasty services in District 1. On balance, the statutory criteria for evaluating CON proposals which focus on problems in existing services do not support the need for an additional adult OHS program at either Baptist or FWBMC. Criteria related to geographic access favor FWBMC. Criteria related to quality of care and long term financial feasibility (due to volume projections) favor Baptist. Rule Criteria AHCA has promulgated Rule 59C-1.033, Florida Administrative Code, which imposes additional requirements on OHS programs. By proposing to use the group of cardiovascular surgeons who currently perform OHS at Sacred Heart, Baptist demonstrated the ability to provide the range of OHS procedures required by rule, including valve repair or replacement, congenital heart defect repair, cardiac revascularization, intrathoracic vessel repair or replacement, and cardiac trauma treatment. FWBMC can recruit cardiovascular surgeons who are qualified to perform the required range of operations. As stipulated by the parties, both Baptist and FWBMC demonstrated the ability to implement and apply circulatory assist devices, such as intra-aortic balloon assist and prolonged cardiopulmany partial bypass. Both Baptist and FWBMC have the supporting departments needed for OHS, including existing hematology, nephrology, infectious disease, anesthesiology, radiology, intensive and emergency care, inpatient cardiac cath, and non- invasive cardiographics. Baptist has more historical experience with innovative cardiology services and a greater range of cardiographic services than FWBMC. OHS programs must be available for elective surgeries 8 hours a day for 5 days a week, with the capability for rapid mobilization, within 2 hours, 24 hours a day for 7 days a week. Baptist can meet the service accessibility requirement of the rule, but FWBMC failed to show that it can. FWBMC's inconsistency concerning the composition of its OHS team and initial low volumes result in uncertainty whether it can meet the requirements for hours of operation. The residents of District 1 are well served by the existing OHS programs, which have the capacity to meet projected need through the year 2000. AHCA's expert testified that FWBMC's application essentially states that ". . . we are going to get patients who would otherwise have gone to the two existing programs; . . . There was no documentation or even discussion that patients requiring the service weren't able to get the service now, or were having to leave the district to do so." The same is true of the Baptist proposal. In this case, need arises solely from the numeric need publication, and the pool of patients treated in the cardiology department at Baptist, whose transfer to Sacred heart for OHS can be avoided if a program exists at Baptist. At some level between AHCA's minimum of 350 and Sacred Heart's maximum capacity of 980 OHS cases, an additional OHS program is needed and Baptist is the provider which has better demonstrated its ability to operate an OHS program. The major disadvantage in the approval of the OHS program at Baptist is the risk that approval is premature and, therefore, detrimental to the quality of OHS services at Sacred Heart absent the implementation of the safeguards proposed by Sacred Heart in the following letter: Sacred Heart Hospital Office of the President 5151 N. Ninth Avenue P.O. Box 2700 Pensacola, FL 32513-2700 May 1, 1995 Mr. James F. Vickery President Baptist Health Care Corporation Post Office Box 17500 Pensacola, FL 32522-7500 Dear Jim: Please accept this letter of support from Sacred Heart Hospital for your March 1995 Certificate of Need application to establish an adult open heart surgery services program in District I. Sacred Heart Hospital recognizes that there is a net need for an additional open heart surgery program in District I, and we believe that the most efficient and cost-effective way to develop such a program is using resources currently available at Baptist Hospital. Sacred Heart Hospital is willing to work with Baptist Hospital in the establishment of the ----proposed open heart surgery program, in a relationship which includes, but may not be limited to, the following: the establishment of a cooperative program involving open heart surgery, angio- plasty and cardiac catheterization performed at both facilities; the sharing of cardiology staff including open heart surgery team personnel in a manner which will result in the most efficient use of resources between the two hospitals and which will also assure that each member participates in a minimum volume of surgical cases necessary for the achievement of quality standards; the coordination of other resources, including facilities and equipment, in an effort to avoid duplication to the greatest extent practical and feasible; the provision of initial and on-going training of open heart surgery personnel at both facilities by Sacred Heart Hospital; the provision of on-going oversight by Sacred Heart Hospital of utilization review and quality improvement programs, procedures and protocols for the cooperative cardiology program for a minimum of two years; and the clinical management by Sacred Heart Hospital of the cooperative cardiology program for a minimum of two years. I am attaching a copy of the action taken by the Executive Committee of our Board of Directors at its meeting on April 28, 1995, if you are in need of such a document. In order to have a complete record of this proposal, to include your acceptance and agreement with the above plan, please con- firm in writing that it will be the ground rules with which we will begin and work towards a first-class Cardiology Program sponsored by our two institutions. Should your March 1995 application be approved by the Agency for Health Care Administration, we anticipate a productive working relationship that will benefit the residents of District I. Sincerely, Sister Irene President and CEO Enclosure There is no proof of record that Baptist responded or agreed to Sacred Heart's proposal, although Baptist relies on these conditions to support the approval of its application. See, Baptist's proposed findings of fact 34.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the application of Fort Walton Beach Medical Center, Inc., be denied, and that the application of Baptist Hospital, Inc., be approved on condition that Baptist provide annually 1.8 percent of total open heart surgery patient days to Medicaid patients and .9 percent to charity, and that Baptist, prior to commencing an OHS program, enter into an agreement with Sacred Heart consistent with the terms proposed in the letter of May 1, 1995. DONE AND ENTERED this 8th day of August, 1996, 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 8th day of August, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-4171 To comply with the requirements of Section 120.59(2), Florida Statutes, the following rulings are made on the parties' proposed findings of fact: Petitioner, Fort Walton Beach's Proposed Findings of Fact. Accepted in Findings of Fact 5. Accepted in Findings of Fact 2. Accepted in Findings of Fact 2 and 4. Accepted in Findings of Fact 4, 26, and 95. Accepted in Findings of Fact 4. Accepted in or subordinate to preliminary statement and Findings of Fact 13. 7-10. Accepted in or subordinate to Findings of Fact 2-5. 11-13. Accepted in or subordinate to Findings of Fact 11, 34, and 68. 14-28. Accepted in or subordinate to Findings of Fact 65 - 76. 29-51. Accepted in or subordinate to Findings of Fact 34 and 66 (with travel time distinguished from transfer times). 52. Rejected in Findings of Fact 73. 53-65. Accepted in or subordinate to Findings of Fact 5, 9- 11, 26, and 93. 66-72. Accepted in Findings of Fact 25-26, 70 and 93. 73-75. Accepted in or subordinate to Findings of Fact 9. Accepted in or subordinate to Findings of Fact 26. Accepted in or subordinate to Findings of Fact 58. Accepted in Findings of Fact 24. Rejected conclusion in first sentence of Findings of Fact 65-66. Accepted in Findings of Fact 25, 70 and 93. 81-83. Accepted in or subordinate to Findings of Fact 26. 84. Accepted in Conclusions of Law 93 and 108-110. 85-88. Accepted in Findings of Fact 93 and Conclusions of Law 108-110. 89. Accepted in Findings of Fact 9, 12 and 13. 90-93. Accepted in or subordinate to Findings of Fact 2, 5, and 65-69. Rejected Conclusions of Law in Findings of Fact 108-110. Rejected first sentence in Conclusions of Law 108 and second sentence in Findings of Fact 64, 87, and 92. 96-97. Accepted in or subordinate to Findings of Fact 29. 98-102. Accepted in part to Findings of Fact 33, 34, 35 and 59. Accepted in or subordinate to Findings of Fact 34 and 37. Rejected in Finding of Fact 25 and 26. Accepted, except first sentence in Preliminary Statement. Rejected in part in Findings of Fact 35, and 88-92. 107-110. Accepted in part in Findings of Fact 57-59. 111-114. Rejected in Findings of Fact 59. 115. Accepted, but see No. 80. 116-118. Accepted in or subordinate to Findings of Fact 57. 119. Accepted in or subordinate to Findings of Fact 62. 120-121. Accepted in or subordinate to Findings of Fact 58. 122. Accepted, except last sentence in Findings of Fact 58. 123-125. Accepted in or subordinate to Findings of Fact 73. 126-128. Accepted in or subordinate to Findings of Fact 72. 129-137. Accepted in or subordinate to Findings of Fact 71. 138-143. Rejected conclusion in Findings of Fact 42-45. 144-154. Accepted in or subordinate to Findings of Fact 49-51 and recommended conditions. 155-174. Accepted in or subordinate to Findings of Fact 12, 13, 26, 28, 58, 71, 93 and 95 and Conclusions of Law 98-104. 175. Rejected as inconsistent with testimony and rules. 176-178. Accepted in or subordinate to Findings of Fact 12, 13, 26, 28, 58, 71, 93 and 95 and Conclusions of Law 98-104. Rejected as inconsistent with testimony and rules. Rejected Conclusions of Law in Findings of Fact 109. Respondent, Baptist Hospital's Proposed Findings of Fact. Accepted in Findings of Fact 2 and 4. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 24. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 27 and 47. Accepted in Findings of Fact 29, 36, and 47. Accepted in or subordinate to Findings of Fact 5 and 8. Accepted in or subordinate to Findings of Fact 5 and 14. Accepted in or subordinate to Findings of Fact 7. Accepted in Findings of Fact 65. Accepted in or subordinate to Findings of Fact 63. Accepted in Findings of Fact 65. Accepted, except last sentence, in Conclusions of Law 110. Accepted in Preliminary Statement. Accepted in preliminary statement and Findings of Fact 41-45. 16-23. Accepted in or subordinate to Findings of Fact 25. 24-33. Accepted in or subordinate to Findings of Fact 11 and 26. Accepted in Findings of Fact 95. Accepted in or subordinate to preliminary statement and Findings of Fact 71. 36-37. Accepted in or subordinate to Findings of Fact 11 and 26. Accepted in Findings of Fact 95. Accepted in or subordinate to preliminary statement and Findings of Fact 71. Accepted in Findings of Fact 70. Accepted in or subordinate to Findings of Fact 11 and 26. Issue not reached. 43-46. Accepted in or subordinate to Findings of Fact 25. 47. Accepted in Findings of Fact 9. 48-49. Subordinate to Findings of Fact 11, 25, 26, and 95. Accepted in or subordinate to Findings of Fact 58. Accepted in or subordinate to Findings of Fact 92. Accepted in or subordinate to Findings of Fact 49. 53-60. Accepted in or subordinate to Findings of Fact 29-39. 61. Accepted in preliminary statement and Findings of Fact 95. 62-73. Accepted in or subordinate to Findings of Fact 57-59. 74-99. Accepted in or subordinate to Findings of Fact 6 and 7 and/or 10-12 and/or 58-59. 100-104. Issue not reached or deemed irrelevant. 105-106. With "serious" deleted, rejected in or subordinate to Findings of Fact 65-69 107-108. Accepted in part or subordinate to Findings of Fact 65-69. 109-110. Accepted in part or subordinate to Findings of Fact 56, and 65-69. 111-112. Rejected, except "serious", in part in or subordinate to Findings of Fact 65-69. 113-114. Accepted in or subordinate to Findings of Fact 65-69. 115. Accepted in Findings of Fact 60. 116. Accepted in or subordinate to Findings of Fact 65-69. 117. Accepted in Findings of Fact 65. 118-122. Rejected conclusions in part in Findings of Fact 59. 123. Accepted in Findings of Fact 59. 124-126. Accepted in part in Findings of Fact 59. 127. Not at issue. 128-129. Subordinate to Findings of Fact 59. 130. Accepted in Findings of Fact 59. 131-132. Subordinate to Findings of Fact 59. 133. Accepted in Findings of Fact 59. 134-135. Subordinate to Findings of Fact 59. 136-137. Accepted in Findings of Fact 33 and 91. 138. Subordinate to Findings of Fact 59. 139-140. Accepted in or subordinate to Findings of Fact 59. 141. Rejected as not having been demonstrated as solely residents' decision. 142-149. Accepted in or subordinate to Findings of Fact 59. 150. Rejected word "gimmick" in Findings of Fact 42-45. 151-152. Accepted in or subordinate to Findings of Fact 59. Accepted in Findings of Fact 58. Accepted in or subordinate to Findings of Fact 58, 71 and 95. Rejected in or subordinate to Findings of Fact 59 and 73. Accepted in or subordinate to Findings of Fact 59 and 73. Accepted in Findings of Fact 14 and 15. 158-159. Rejected in Findings of Fact 72. 160-161. Accepted in or subordinate to Findings of Fact 79. 162-165. Rejected conclusion in Findings of Fact 79. 166. Rejected in Findings of Fact 9, 12, 70, 93. 167. Accepted. 168. Rejected as not supported by the evidence. 169-180. Accepted in or subordinate to Findings of Fact 24 and 49-51. 181-190. Accepted in or subordinate to Findings of Fact 41-45. 191-192. Accepted in Findings of Fact 70 and 93. (Footnote rejected.) 193. Accepted in Findings of Fact 65. 194-195. Rejected in Findings of Fact 66-68. 196. Accepted in Findings of Fact 65. 197-199. Issue not reached. 200. Accepted in or subordinate to Findings of Fact 13, 71 and 95. 201. Rejected in Findings of Fact 13, 71 and 95. 202. Accepted in or subordinate to Findings of Fact 40-45. 203. Accepted in or subordinate to Findings of Fact 47. 204. Accepted in or subordinate to Findings of Fact 48. 205-206. Accepted in or subordinate to Findings of Fact 49. 207. Subordinate to Findings of Fact 52. 208. Accepted in Findings of Fact 71 and 95. 209. Subordinate to Findings of Fact 52. 210-213. Accepted in general in Findings of Fact 26 as compared to Findings of Fact 37. 214. Accepted in Findings of Fact 53 and 54. 215. Accepted in Findings of Fact 52. 216. Accepted in Findings of Fact 57-59. 217. Accepted in Findings of Fact 60. COPIES FURNISHED: Richard Patterson, Senior Attorney Agency for Health Care Administration 325 John Knox Road, Suite 301 Tallahassee, Florida 32303-4131 Michael J. Cherniga, Esquire David C. Ashburn, Esquire Greenberg, Traurig, Hoffman Lipoff, Rosen and Quentel Post Office Box 1838 Tallahassee, Florida 32302 John Radey, Esquire Jeffrey Frehn, Esquire 101 North Monroe Street, Suite 1000 Post Office Drawer 11307 Tallahassee, Florida 32302 R. S. Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403
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
Findings Of Fact The Respondent, Camilia Dwyer, is a licensed medical doctor holding license number ME 0025985 issued by the Board of Medical Examiners. At all times relevant to this proceeding, the Respondent was employed as a physician at South Miami Medical Services, located at 2400 South Dixie Highway, Miami, Florida, a health service organization holding itself out to the public as a clinic for the treatment of stress. Quaalude is the trade name for methaqualone, which is a legend drug and a controlled substance. Ms. G. T. Auspitz, an investigator for the Department of Professional Regulation, was seen as a patient by the Respondent on January 25, 1982, as part of an investigation conducted by Ms. Auspitz. Ms. Auspitz had called the clinic previously and made an appointment for her visit. On this first visit, Ms. Auspitz filled out a medical history and personal questionnaire, was weighed, was seen by a psychologist, and had a blood sample taken by the Respondent, who also physically examined her. Ms. Auspitz's presenting complaints were sleeplessness, loss of weight, irritability, nervousness and migraine headaches. The medical history given by Ms. Auspitz, which was reviewed by the Respondent, was not accurate. Ms. Auspitz had not suffered any loss in weight, did not suffer from migraine headaches, did not have trouble sleeping and was not irritable or nervous. During Ms. Auspitz's 15- to 20-minute interview with the psychologist, she was questioned concerning her presenting complaints and personal history. This discussion centered on her work, her personal relationships, and areas of her personal life which could give rise to her presenting complaints. Ms. Auspitz indicated that she was angry with her boyfriend and did not feel secure in the relationship. The psychologist noted that her presenting complaints arose out of Ms. Auspitz's problem with her boyfriend. The basic information given the psychologist by Ms. Auspitz concerning her personal life was not correct but was part of her investigative cover story. After seeing the psychologist, Ms. Auspitz was examined by the Respondent. The Respondent asked Ms. Auspitz about her weight loss, checked her chest, examined her torso and her extremities, and took blood for a blood test. The Respondent asked Ms. Auspitz if she had previously taken Quaaludes, to which Ms. Auspitz answered in the affirmative. The Respondent wrote a prescription for 45 Quaaludes for Ms. Auspitz and placed the prescription in Ms. Auspitz's medical folder. Ms. Auspitz took the medical folder to Richard Lubin (phonetic), the operator of the clinic, to whom she paid $100 in cash and received the prescription for Quaaludes and another prescription for multiple vitamins. On January 26, 1982, Ms. Auspitz was seen and examined by John V. Handwerker, M.D. Dr. Handwerker had been employed by the Department of Professional Regulation for the purposes of examining Ms. Auspitz, rendering his expert opinion regarding her health and need for a prescription for Quaalude, and to testify in any subsequent proceedings if necessary. Ms. Auspitz did not tell Dr. Handwerker she was suffering from stress, and the medical history which she gave him was complete and accurate. Dr. Handwerker's objective findings were that Ms. Auspitz was a white female in her late 30's or early 40's in apparent good health. Based upon his objective findings and the medical history which Ms. Auspitz gave him, Dr. Handwerker concluded that Ms. Auspitz was physically and emotionally healthy and did not require medication with Quaalude. Dr. Handwerker also had an SMA/26 blood test run on Ms. Auspitz. The results of the SMA/26 blood test revealed the presence of mephobarbital 2/ in Ms. Auspitz's blood at a therapeutic level. Ms. Auspitz stated that she was not taking this drug and to her knowledge had not taken any medication containing said drug. Ms. Auspitz surmised that this medication was dispensed by mistake in a possible mix-up at a pharmacy instead of a prescription of Provera, which she was taking, due to the similar appearance of both medications. On February 26, 1982, Ms. Auspitz again saw the Respondent. On this occasion, she did not see a psychologist. In response to an inquiry from the Respondent, Ms. Auspitz said that she felt fine. The Respondent told Ms. Auspitz that her blood test revealed she had a low potassium level and advised her to eat bananas, a food with high potassium content. The Respondent wrote a second prescription for Ms. Auspitz for 40 Quaaludes. Ms. Auspitz paid Lubin for the office visit and left the clinic. Records from two pharmacies of prescriptions written by the Respondent were introduced. These records reflect that the Respondent wrote 1,855 prescriptions for over 80,000 Quaaludes in the four and a half months she was employed at the clinic. Dr. Handwerker testified and offered his opinion on the medical necessity for the prescription of Quaalude in such quantity. Dr. Handwerker stated that even without seeing the patient records he could say with reasonable medical certainty that prescription of that quantity of Quaalude was excessive. Dr. Handwerker buttressed his opinion with the fact that prolonged use of Quaalude (more than two weeks) causes the body to produce an enzyme which counteracts the effect of Quaalude as a sleeping medication. The Respondent testified concerning the charges against her. Respondent's medical specialty is anesthesiology. She graduated from medical school in 1962 and interned in anesthesiology at Case Western Reserve, where she practiced until 1974. From the time the Respondent came to Miami, Florida, in 1974, until approximately 1977, she was the anesthesiologist at Coral Gables Hospital. Thereafter, she was the anesthesiologist at Victoria Hospital in Miami until 1980, when she suffered a heart attack. During the period of her practice as an anesthesiologist, the Respondent had little if any contact with nonsurgical patients and little occasion to prescribe Quaalude. After she had recovered from her heart attack, the Respondent wanted to return to practice, but initially not in a full-time capacity and not as an anesthesiologist. She responded to an advertisement placed by South Miami Medical Services for a physician to practice part-time in a clinical setting. After an interview with Mr. Lubin, the Respondent took the position and began work in November of 1981. When she first went to work for the clinic, the Respondent felt it was a legitimate medical facility providing treatment to its patients who were suffering from stress. She was advised by other physicians at the clinic that Quaalude was the drug of choice to treat patients. The Respondent further stated that in January of 1982 she began to have doubts about the operation of the clinic and the prescription of Quaalude to patients as a drug of first choice. Subsequently, however, she continued to work at the clinic and continued to prescribe Quaalude as the drug of first choice. In late February 1982, the Respondent had a direct confrontation and fight with Lubin over the prescription of Quaalude for patients, and at that time she quit her employment. However, she returned to work for the clinic for approximately two weeks to give Lubin time to replace her. During this period, the Respondent continued to use Quaalude as the drug of choice in the treatment of patients. Linda C. Lewis, R.N., testified concerning her employment at South Miami Medical Services. Ms. Lewis was employed at the clinic from August 1981 until January 1982 while taking a respite from her nursing specialty as a dialysis nurse. Ms. Lewis described the general operation of the clinic, which was consistent with that described by both the Respondent and Ms. Auspitz. Blood tests were screened by Ms. Lewis, and she called any patients who exhibited severe abnormalities. All patients were seen by appointment only and were generally seen by the psychologist and medical doctor on each visit. Ms. Lewis believed that the clinic was a legitimate health service organization until reports in January 1982 indicated that there were problems in general with stress clinics. These reports influenced Ms. Lewis to quit her job shortly after January 25, 1982, the date of Ms. Auspitz's first visit to the clinic. Said reports are not deemed to be accurate or truthful and are mentioned only as they related to Ms. Lewis's state of mind. The Respondent was cooperative with Ms. Auspitz when interviewed by her after the Respondent ceased to work at the clinic. Respondent stated that she did not realize Quaalude was a problem as a street drug until her 19-year- old son told her about Quaalude abuse after she had left the clinic. The Respondent is currently practicing in her own small general practice in Miami. The majority of her patients are elderly.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, and considering the facts in mitigation, the Hearing Officer recommends that the Respondent, Camilia Dwyer, M.D., have her license suspended for a period of two years, and that said suspension of the Respondent's license be abated on the following conditions: That the Respondent pay a fine of $4800 in 24 payments of $200 each; That the Respondent attend courses as directed by the Board to increase her knowledge of her professional responsibilities with regard to the prescription of controlled substances and legend drugs; and That the Respondent's right to prescribe controlled substances be limited by the Board in its discretion. DONE and RECOMMENDED this 13th day of June, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of June, 1983.
Findings Of Fact Respondent is and has been at all times material hereto a licensed physician in the state of Florida, having been issued license number ME 0019670. Respondent is a board-certified obstetrician and gynecologist. On March 20, 1989, at approximately 1:04 a.m., Patient #1 (Derrick Prince) was presented to the emergency room at Weems Memorial Hospital in Apalachicola, Florida. Prince was a twenty-year-old male suffering from a stab wound to his left thigh that was inflicted by a butcher knife. Prince was actively bleeding and had lost a large amount of blood, as evidenced by the condition of his clothing, the amount of blood on the walls and floor of the hospital, and blood on his companions. Prince was placed on a table in the trauma room. When his blood-soaked pants were removed, blood spurted from the wound on his left thigh to a height of one to two and one-half inches. The emergency room R.N., Ms. Page, controlled the bleeding by direct pressure, first with her hand and then with a towel. Prince was semiconscious, muttering, "I can't breathe," and was randomly combative. Emergency room personnel had to forcibly restrain him on the table. Respondent, working as the emergency room physician, was summoned to the trauma room by the nurse. Hospital personnel attempted to establish Prince's blood pressure and pulse. Ms. Simpson, the L.P.N., could detect no blood pressure or pulse on Prince. Ms. Page, the R.N., could detect no blood pressure or pulse although she checked radial, cubital, and popliteal areas. Mrs. Estes, a paramedic who came in to help, could detect no pulse. Respondent was advised repeatedly that no blood pressure or pulse could be detected. Respondent instructed Ms. Simon to call respiratory and laboratory personnel and the Sheriff's Department, which she did. The laboratory director, Tracy Pierce, was called at his home in St. Joe Beach. When pressure was removed from the wound area, there was little blood on the towel and the wound was not bleeding. Respondent commented to the nurse that she did a good job stopping the bleeding. The nurse and paramedics attempted to begin intravenous infusion but were unable to establish any IV lines because all veins were concave (collapsed). The nurse and paramedic interpreted this peripheral vascular collapse as meaning there was no blood volume to keep the veins open. Respondent was advised that no IV could be started because the veins were concave. Respondent had ordered a suture tray. He explored the wound with his finger and commented that the wound went all the way to the bone. Respondent commented that the boy would be all right, that he wasn't hurt that bad. Respondent proceeded to treat Prince by suturing the wound in three layers. He stated he tied off some minor arterial branches during this suturing. After suturing the wound, Respondent again commented that the boy would be all right because he wasn't hurt that bad. After suturing the wound and noting no jugular access, Respondent began a cutdown in order to establish an intravenous line. Ms. Estes, the paramedic, suggested using MAST trousers to help venous pressure, and Respondent agreed. MAST trousers also can act as a tourniquet to control bleeding. The pants were applied and Prince's legs were elevated in an effort to establish a positive venous pressure. At 1:30 a.m., while Respondent was setting up for a cutdown, Prince had a seizure and respiratory arrest. He was intubated by Respondent. He vomited, was suctioned, and breathed by AMBU bag. Respondent then inquired, for the first time, about the availability of blood. He was told there was none in the hospital. Sufficient blood was available and could have been obtained from Gulf Pines South Hospital in St. Joe within 30 minutes had a request been made for Mr. Pierce to bring it with him. Mr. Pierce arrived during the cutdown procedure. Mr. Pierce was the laboratory director for both hospitals. An intravenous fluid line was finally established via the cutdown and some fluid begun. The Life-Flight helicopter was ordered at approximately 1:40 a.m. At approximately 1:55 a.m. Prince suffered a cardiac arrest. When Life-Flight arrived at 2:40 a.m., it was impossible to transport Prince in his moribund condition. Resuscitative efforts were employed until approximately 3:00 a.m., when Respondent pronounced Prince dead. An autopsy conducted by Dr. Thomas Wood, the Medical Examiner, on March 21, 1989, revealed that the stab wound to the left thigh was located six inches above the knee, was seven inches deep, passed by the bone, and completely severed both the femoral artery and vein. The autopsy also revealed 3 layers of sutures: the first closing the skin and two other layers within the subcutaneous fatty tissue, not more than three-fourths of an inch below the surface. There was no evidence of any arterial or venous repair. The cause of death of Derrick Prince was exsanguination from the severed femoral vessels. After an investigation was initiated, Respondent was interviewed by Investigator Reese. Respondent stated that peripheral pulses were obtained and the patient's pulse rate was 120 from admission until the time of his respiratory arrest. Respondent stated to Investigator Reese that two IVs were started but that the patient pulled them out. Statements of Ms. Page and Ms. Estes written immediately after the incident indicate that no IVs were started, not because the patient pulled them out, but because all veins were collapsed. Respondent stated to Investigator Reese that he had to leave the patient after suturing the wound to examine a family member across the hall. At no time did Respondent leave the emergency room. Respondent stated to Investigator Reese that there was no indication that the femoral vessels had been cut, as he had checked the wound and that is not the direction the femoral artery runs. Respondent believed the wound was not life-threatening, that after the bleeding was stopped and the wound sutured the patient was in pretty good shape and was going to be fine. Respondent was not aware the femoral vessels had been severed until informed at the circuit court hearing of June 6, 1989. Respondent reported in his medical record the patient "became shocky" at approximately 1:30 a.m., after the suturing. The massive blood loss, disorientation and combativeness, peripheral vascular collapse, and lack of vital signs all indicate Prince was in shock when admitted and Respondent did not recognize this fact. Respondent instead believed Prince to be a combative drunk and his course of treatment indicates this perception. The emergency room physician should prioritize his actions in such a way that the most critical factor is treated promptly and other, less dangerous factors are given lesser priority. The correct treatment of this patient would have been for Respondent to direct all efforts of the E.R. team toward immediately reestablishing Prince's blood volume, then blood replacement. The wound itself could have been easily controlled by pressure, tourniqueted by the MAST pants, or even left for later care. Rather than misdirecting his attention to suturing the wound, Respondent should have performed the cutdown or placed a CVP catheter to start IV fluids as soon as it was evident that the nurses could not start the IVs and Respondent should have ensured that blood was being obtained as soon as possible. Respondent's suturing of the wound was ineffective in any case, as only superficial layers were stitched, and the wound remained unexplored. Respondent did not practice with the acceptable level of care, skill and treatment of a reasonably prudent similar physician under similar conditions and circumstances in that Respondent did not correctly assess Prince's physical condition and therefore misdirected his attention to suturing the wound instead of establishing intravenous access for immediate fluid replacement. Respondent's entire written medical record consists of his "Emergency Room Note." Respondent has documented no detailed history or physical examination: there is no documentation of the amount of blood loss, of the spurting blood, of the initial assessment of the patient's shock, or of consideration that the massive bleeding could have been from the great vessels and life threatening; there is no record that Respondent ever felt for pulses or obtained a pulse, no record of any neurological assessment or vascular status of the left leg distal to the wound, no conjunctival color noted, and no justification for giving his attention to the wound rather than immediately attempting to replace the lost blood volume; there is no note of a request for blood, how it could be or why it was not obtained. In short, prior to the cardiac arrest, there are no medical records written by Respondent which justify the course of treatment he followed with Prince.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a Final Order and therein REVOKE the medical license of Elliott F. Monroe. DONE and ENTERED this 19th day of June, 1991, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of June, 1991. APPENDIX TO THE RECOMMENDED ORDER IN CASE NO. 91-0377 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on the proposed findings of fact submitted by the parties in this case. Specific Rulings on Proposed Findings of Fact Submitted by Petitioner, Department of Professional Regulation Each of the following proposed findings of fact is adopted in substance as modified in the Recommended Order. The number in parentheses is the Finding of Fact which so adopts the proposed finding of fact: 2-13(1-9) and 14-53( 11-50). Proposed finding of fact 1 is unnecessary. Specific Rulings on Proposed Findings of Fact Submitted by Respondent, Elliott Monroe Respondent's proposed findings of fact are subordinate to the facts actually found in this Recommended Order. COPIES FURNISHED: Mary B. Radkins, Senior Attorney Department of Professional Regulation Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Alfred O. Shuler Attorney at Law Post Office Box 850 Apalachicola, FL 32320 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact The Respondent is duly licensed by the Florida State Board of Osteopathic Medical Examiners as an osteopathic physician and surgeon. He has been a licensed practicing osteopathic physician since July, 1962. He has a very sound educational and professional background, and is on the staff of three hospitals. He is presently engaged in the general practice of osteopathic medicine in Dade County, Florida. During March, 1976, the Respondent was associated with the Martin Luther King Memorial Hospital in Miami Beach, Florida. King Memorial is not a full service hospital. Its facilities are approximately the size of an average house. It has x-ray equipment, but it does not have a blood bank. King Memorial is not equipped to perform major surgery. Prior to March 13, 1976, Cycloria Vangates, a 32-year old black female, visited King Memorial. She was pregnant, and she wished to terminate the pregnancy. Miguel Dreize, M.D., who was at that time associated with the Respondent at King Memorial, examined Mrs. Vangates. He had difficulty determining the precise term of Mrs. Vangates' pregnancy, but he estimated that she was at the beginning of the second trimester. Dr. Dreize determined that Mrs. Vangates was anemic. He treated her in order to improve that condition. She was scheduled to have an abortion on the morning of March 13, 1976. Her blood was re-tested prior to the operation being performed, and it was determined that she was in good condition. The Respondent was in charge of performing the abortion. He was assisted by Dr. Dreize. The procedure was performed without significant incident. A small laceration on the cervix on the outside of the uterus was observed, and it was corrected. Immediately after the surgery at approximately 9:30 a.m., Mrs. Vangates' vital signs were good. Her blood pressure was 120/60, and her pulse rate was normal. Within ten to thirty minutes later the patient's blood pressure was again taken by a nurse, and the pressure had fallen drastically to 60/?. The nurse summoned the Respondent. The Respondent placed the patient on i.v. fluid, and administered Aramine. Aramine is a drug which constricts blood vessels, thus reducing the cardiovascular space, causing blood pressure to increase. Aramine can effectively raise blood pressure, but if reduction of blood pressure is caused by a loss of blood, Aramine does nothing to replace the lost fluid. The patient's blood pressure rose, but only to approximately 70/40. Her blood pressure remained fairly stable at that rate, falling gradually until by approximately 1:40 p.m. the blood pressure reading was 50/40. No vaginal bleeding was observed, and the patient's stomach was not hardened nor distended, which would indicate severe internal bleeding. By 1:00 p.m. the patient was described as "clammy". At approximately 12:00 noon the Respondent ordered blood from a local blood bank. He requested that the blood be ordered "STAT". This is an acronym which would indicate that the blood was needed on an emergency basis. Despite the Respondent's instruction, the nurse who filled out the order form ordered the blood on an "ASAP" basis. This designation would indicate that the blood was needed "as soon as possible", but not on a high priority basis. An employee of King Memorial was sent to the blood bank (the John Elliott Blood Bank). The blood bank is located approximately 30 minutes away from King Memorial by automobile. The employee drove to the blood bank, and submitted the order form. He waited there, and approximately 30 minutes later was told that he had the wrong papers, and insufficient samples. He returned to King Memorial, and received a corrected order form, which still reflected that the blood was needed on an "ASAP" basis. He returned to the John Elliott Blood Bank. He then waited 30 to 45 minutes more before the blood was delivered to him, and he returned with it to King Memorial. The blood did not ultimately arrive at King Memorial until approximately 3:00 p.m. when it was immediately administered to the patient. The Respondent had earlier administered a plasma substitute known as Dextran. The Respondent left King Memorial at approximately 1:40 p.m. to attend to patients at a different facility. He left the patient under the care of another physician. By 3:00 p.m. the patient's condition was deteriorating. Her stomach was beginning to distend. The Respondent was contacted, and he gave instructions to immediately arrange a transfer of the patient to Osteopathic General Hospital in Miami Beach. Osteopathic General Hospital is located approximately 8 minutes by automobile away from King Memorial. The Respondent notified physicians at Osteopathic General of Mrs. Vangates' condition, and personnel at Osteopathic General prepared for emergency surgery. At least three phone calls were made to the ambulance service following 3:00 p.m. Despite these efforts, and the fact that the two hospitals were located in such close proximity, the ambulance did not arrive at King Memorial until 4:22 p.m. When Mrs. Vangates arrived at Osteopathic General, she was in hypovolemic shock. This is a condition characterized by loss of fluid within the vascular space. She had virtually no vital signs, and an irregular heart beat. She was suffering from uterine hemorrhage, and brain damage which resulted from the loss of blood. An abdominal incision was made, and considerable blood and blood clots were found. An artery on the right side of her abdomen was damaged, and there was a 6 cm x 7 cm tear in the uterus, and a rupture of the entire uterine wall. An emergency hysterectomy was performed. On March 17, 1976, Mrs. Vangates died. She had lost considerable blood following surgery on March 13, and the loss of blood caused damage to the patient's vital organs. She died as a result. When the patient's blood pressure dropped drastically following surgery, the Respondent concluded that since there were no additional indications of hemorrhage, the cause was loss of blood during surgery, and a reaction to the anesthesia that had been administered. It is for that reason that he took steps to administer Aramine, so as to cause a rapid rise in the blood pressure. The Respondent's conclusion as to the cause of the drop in blood pressure was at that time reasonable under the circumstances. Lacerations and ruptures of the uterus are not an uncommon occurrence during the performance of abortions. This is especially so when an abortion is performed in connection with a pregnancy in the second trimester. In view of the possibility that the drop in blood pressure could have been the result of a substantial loss of blood, and the fact that blood was not available at King Memorial, the Respondent should have immediately ordered blood at the first signs of the drastic reduction in the patient's blood pressure. Administering Aramine was at best a temporary solution. Administering a plasma substitute was also a temporary measure. The Respondent did not make any effort beyond superficial ones to determine whether the patient was bleeding. By waiting until 12:00 noon to order the blood, he subjected the patient to the risk that the blood could not be obtained efficiently. Due to the facts that the blood was not ordered until 12:00 noon, that the blood was not obtained efficiently, and that the ambulance was slow in arriving, the patient's vital organs were subjected to damage as a result of loss of blood, ultimately resulting in her death. While the Respondent is not fully responsible for the delays, he was in a position to have taken steps that would have obviated the disastrous effects of the delays. In Count II of the Petitioner's complaint against the Respondent it is alleged as follows: That you, PAUL S. GLASSMAN, beginning on the 21st day of June, 1975 and continuing through the 22nd day of April, 1976, did unlaw- fully and feloniously agree, conspire, combine or confederate with ESTEBAN BOVEDA; MERCEDES BOVEDA; ESTEBAN BOVEDA, JR; MARIVA BOVEDA; OSWALDO MAERO and with others, to commit a felony to-wit: Grand Larceny and in further- ance of the unlawful scheme or conspiracy, you did meet with the above mentioned indi- viduals on various occasions to discuss and plan details as to the time, place and method of the commission of acts leading to the said larceny of monies from insurance companies by way of false and fraudulent claims to be made upon them as a result of contrived and false injuries, in violation of Section 777.04(3) and Section 833.04, Florida Statutes. In addition, on the following dates and times you did unlawfully and feloniously steal from the possession and lawful custody of the following named companies goods and lawful money in excess of One Hundred Dollars ($100.00) with the intent to permanently deprive or defraud the true owner of its property in vio- lation of Section 812.021(1)(a), (2)(a) Florida Statutes: November 3, 1975 Allstate Insurance Company March 3, 1976 Omaha Indemnity Company December 24, 1975 The Unity Mutual Life Insurance Company January 15, 1976 The Prudential Insurance Company of America The above is in violation of Section 459.14(2) (h), (k), (m) and (n) , Florida Statutes. At the hearing the Petitioner, through counsel, dropped the allegations of conspiracy, and stipulated that in the event the Respondent's conviction on the remaining charges were overturned on appeal, those charges would also be dismissed. To establish the allegations contained in Count II, the Petitioner presented a transcription of the testimony of Esteban Boveda, Mercedes Boveda, Esteban Boveda, Jr., and Maria Boveda. This testimony was originally presented at a criminal trial involving the same facts. The testimony of the Bovedas has been carefully examined, and it is concluded that their testimony is not worthy of belief. Esteban Boveda testified that he arranged with Oswaldo Maero to stage an automobile accident, and to stage fake injuries on the part of members of his family. Boveda testified that Maero made all of the arrangements, and gave all the instructions. Ultimately each of the Bovedas was examined by the Respondent, Dr. Glassman, who had them hospitalized. Esteban Boveda's testimony is not credible. In the first place, he was an admitted conspirator in a scheme to defraud numerous insurance companies, and he was willing to involve his wife, his 13 year old son, and his 10 year old daughter in the scheme, instructing each of them to lie about the accident. Furthermore, he plead guilty to criminal charges similar to those lodged against the Respondent, in exchange for an agreement that he would be placed on probation rather than in prison. It is clear that these events occurred at a time when Boveda had very little understanding of the English language, and none of his testimony with respect to anything Dr. Glassman said or did is worthy of belief. Mercedes Boveda, Esteban's wife, gave conflicting statements to the State's Attorney, during her depositions prior to the criminal trial, and at the criminal trial. Her willingness to lie on her husband's behalf was amply demonstrated. She, like her husband, had very little understanding of the English language, and her testimony is not creditable. The testimony of the two Boveda children is likewise not worthy of belief. They each testified that they would lie on their father's behalf if they were instructed to do so. It is evident that they were instructed to do so during the course of the accident, and that they would be willing to lie in court if so instructed by their father. The children had been in the United States for only one year at the time of these events, and had minimal understanding of the English language. All of the testimony that exists with respect to anything the Respondent said to the Bovedas about their injuries came from the two Boveda children. Their testimony was too clear and unambiguous in this respect, while being totally ambiguous and unclear in all other respects, to be worthy of belief. The Respondent testified on his own behalf with respect to the allegations of Count II. He testified that he diagnosed the Bovedas' ailments based on the history, and that his diagnosis was confirmed by other physicians. He testified that he was not part of any conspiracy to defraud insurance companies, and that he received only a single payment for the treatment that he administered the Bovedas. The Respondent's testimony is creditable, and has been accepted.
Findings Of Fact The Petitioner Theresa Didick is a licensed laboratory technologist holding licenses in the specialties of hematology and chemistry. She has a substantial amount of experience as a laboratory technologist with the major emphasis of her work involving performance of all sorts of blood tests and blood chemistry analyses as well as urinalysis tests. She has approximately 15 hours of higher education courses in such fields as biology, psychology and English. She has extensive experience in the operation and maintenance of laboratory equipment. From September, 1968 to September, 1968 the Petitioner worked as a medical technician et Pondville State Hospital in Norfolk, Massachusetts, performing duties involving routine hematology, chemistry and bacteriology in a laboratory. From September, 1969 to July, 1970 she worked as a medical technician at Beth Israel Hospital in Boston, Massachusetts again performing routine hematology and urinalysis testing. Her experience in the medical laboratory field then lapsed until January, 1973 when from that date until September, 1973 she worked at Milford Hospital, Milford, Massachusetts, performing STAT blood and urine tests. Then from September, 1973 to February of 1976, Petitioner worked as a medical-technologist at Massachusetts Hospital School at Canton, Massachusetts. Her duties there consisted of running a small "one-person" lab conducting routine blood tests which included manual blood chemistries, hematology and bacteriology, as well as being responsible for maintaining inventory and ordering lab supplies. From December, 1976 to February, 1977 she worked as a part-time consultant medical-technologist for that same entity, providing technical assistance in updating and preparing the laboratory and the current lab technician for accreditation inspection. From March, 1976 to February, 1984 she worked as a medical technologist at Norwood Hospital and Southwood Community Hospital in Norwood, Massachusetts. Her responsibilities there as a technologist were for all aspects of hematology and chemistry, including maintaining quality control, maintaining instruments and equipment, as well as training students and new employees. Her experience at Massachusetts Hospital School for almost four years did involve delivery of blood to operating rooms, but did not specifically involve "blood banking" such. The Petitioner's experience in immunohematology or "blood banking," which involves the sub-specialty of blood grouping, typing and cross matching of blood, RH typing, the withdrawal of blood from donors and the storage and dispensation of blood and blood derivatives, consists of her duties from January, 1973 to September, 1973 at Milford Hospital in Milford, Massachusetts, and her approximate four years tenure at Massachusetts Hospital School. That last experience is only partially pertinent in that she was responsible insofar as blood banking is concerned, for only dispensing and delivery of blood to operating rooms. Such experience, however, even if all pertinent under the sub- specialty of immunohematology or blood banking does not amount to six years of pertinent experience. Unfortunately neither does the other experience of the Petitioner, involving work in laboratories performing routine blood tests involving blood chemistry, hematology and bacteriology, as well as urinalysis, constitute the practice or performance of blood banking or immunohematology. In short, the Petitioner did not establish that she has six years or more experience in performing all of the different types of tests and other duties involved in blood banking, as opposed to the mere delivery of blood to operating rooms or the mere routine chemistry and hematological blood tests performed in the normal operation of a clinical laboratory. The pertinent experience at Milford Hospital which involved more of the duties of blood banking only amounts to less than a year of such experience. George S. Taylor, Jr. is a biological scientist in the Lab Personnel Licensing Agency of the Department of Health and Rehabilitative Services. He established that it is consistent department policy to require six years experience in the field of immunohematology or blood banking consisting of performance for those six years of the various procedures and processes involving blood banking delineated above. The performance of routine blood chemistry and hematological tests and urinalyses normally performed in clinical laboratories does not constitute experience in the field of immunohematology blood banking for purposes of licensure as a technologist in that sub-specialty by the department.
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 the petition of Theresa M. Didick for licensure as a laboratory technologist in the sub-specialty of immunohematology be DENIED. DONE and ORDERED this 10th day of May, 1985 in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 10th day of May, 1985. COPIES FURNISHED: Ms. Theresa M. Didick 1675 Strasburg Drive Port Charlotte, Florida 33952 Anthony N. DeLuccia, Jr., Esquire David Pingree, Secretary Department of Health and Department of Health and Rehabilitative Services Rehabilitative Services 8800 Cleveland Avenue, S. 1323 Winewood Boulevard Fort Myers, Florida 33907 Tallahassee, Florida 32301
Conclusions The attending nurse's actions and inactions fell below the standard of professional care applicable under the circumstances. The consequences of a below normal fetal heart rate are so critical that, even if the nurse was suspicious that the monitor was not working properly, her proper response should have been to take immediate steps to determine whether the fetus was in distress, to intervene with resuscitation measures if needed, and to alert a doctor. Her failure to take appropriate action was negligence and was the proximate cause of the injuries suffered by Janaria. South Broward Hospital District, doing business as Memorial Regional Hospital, is liable as the nurse's employer. There are many reasons for entering into a settlement agreement other than the perceived merits of the claim and, therefore, I am not precluded from reviewing the terms of the parties' settlement agreement in this matter and determining whether they are reasonable under the totality of the circumstances. In this case, the settlement amount is far less than the usual jury verdict for injuries of this nature. Had this case involved a private hospital, the settlement amount would probably have been much larger. Therefore, I believe it would be fair and reasonable for the Senate to pay an award of $550,000 (or 50 percent more than the agreed settlement amount). ATTORNEY’S FEES AND LOBBYIST’S FEES: In compliance with s. 768.28(8), F.S., the Claimants' attorneys will limit their fees to 25 percent of any amount awarded by the Legislature. However, Claimants’ attorneys did not acknowledge their awareness of the provision of the bill that limits attorney’s fees, lobbyist’s fees, and costs to 25 percent of the award. They propose a lobbyist's fee that would be an additional 6 percent of any award. OTHER ISSUES: The bill should be amended to correct the name of the defendant to South Broward Hospital District. Of the two annuity options presented by the Claimants' attorney, I believe the option that guarantees payment for 40 years is the better option. In addition, because Shakima Brown received nothing in the settlement, I believe the bill should specify that, in the event that Janaria dies before the trust fund is exhausted, the balance in the trust fund should go to Ms. Brown. The District stated that paying a claim in the amount of $300,000 would not impair its ability to provide normal services. RECOMMENDATIONS: For the reasons set forth above, I recommend that Senate Bill 38 (2008) be reported FAVORABLY, as amended. Respectfully submitted, cc: Senator Ted Deutch Representative Kelly Skidmore Faye Blanton, Secretary of the Senate Bram D. E. Canter Senate Special Master House Committee on Constitution and Civil Law Tony DePalma, House Special Master Counsel of Record
The Issue The issues to be determined in this proceeding are whether Respondent violated section 458.331(1)(t)1., Florida Statutes (2012), and if so, what penalties should be imposed.
Findings Of Fact Based upon the Stipulation of the parties and the evaluation of the evidence presented at hearing, the following facts are found: At all times material to the allegations in the Administrative Complaint, Respondent was a licensed medical doctor within the State of Florida and held license number ME 109501. Respondent’s address of record is 216 Elm Drive, Chattahoochee, Florida 32324. The Department presented no evidence of prior discipline against his license. In 2013, Respondent was under contract to furnish health care services to inmates at Suwannee Correctional Institution (SCI). This case involves the care and treatment for hypertension that Respondent provided to R.G. while R.G. was an inmate at SCI in June and July 2013. David Libert, M.D., who testified on behalf of the Department, is a Board-certified family practice physician who has been licensed in Florida since 1983. Dr. Libert sees patients in a clinical setting approximately three days a week but has never practiced in a correctional institution setting. Dr. Libert testified that a “perfect” blood pressure reading is 120/80. A reading that is under 140/90 is considered acceptable, but blood pressure that is consistently above 140/90 indicates hypertension. Malignant hypertension, or hypertensive emergency, is an acute elevation of blood pressure that is associated with end organ damage. End organ damage is the affect that the high blood pressure has on certain parts of the body, such as the brain, heart, and kidneys. The traditional benchmark reading that signals malignant hypertension is 180/120, which Dr. Libert testified is an arbitrary number but represents the “old” definition of the condition. According to Dr. Libert, newer studies define malignant hypertension as an acute rise on the height in blood pressure associated with end organ damage, even if the blood pressure reading does not go as high as the 180/120 measure recognized in older literature. The record is not clear when the change in definition took place, and if that change reflects the standard of practice in June 2013. Dr. Libert did not describe what constitutes an acute rise in blood pressure, either in terms of the length of time by which it is measured, or how much of a change in blood pressure constitutes an acute rise. The systolic reading is the top number in a blood pressure reading and represents the maximum pressure that is exerted on the arteries with the contraction of the heart. The diastolic reading represents the pressure after the heart has relaxed from its beat and is the lower number in a blood pressure reading. While 180/140 is the traditional reading identified as a signal for malignant hypertension in “older” literature, there was no testimony as to whether systolic and diastolic readings are equally important, or whether one is more important than the other when determining that a patient’s blood pressure is too high. In other words, no testimony was presented to answer the question of whether, for example a blood pressure reading of 185/96 or 170/133 would be considered a symptom of malignant hypertension. While there is no question both readings would indicate hypertension, the evidence did not indicate whether it is enough to have one of the two pressure readings above the 180/120 level to signal the possibility of malignant hypertension. The Department of Corrections has protocols for treatment of different systems of the body. The form for the Hypertension Protocol, which is included several times within R.G.’s medical records from Suwannee, includes several categories of information to be addressed by treating personnel, such as Subjective (which includes the patient’s chief complaint and current symptoms); Objective (which requires notation of vital signs, such as temperature, pulse, respiration, blood pressure, oxygen saturation and weight); Findings Requiring Immediate Clinician Notification; Plan; and Education. Under the heading “Findings Requiring Immediate Clinician Notification,” there are several factors that a health care provider (typically in this setting, a nurse) would check before the need to contact a physician arises. Those factors are blood pressure greater than 160/100 (see PLAN first); oxygen saturation less than 93 percent; heart rate less than 60 or greater than 110; wheezing (chest congestion); blurred vision; pedal edema extending to above the knees; severe headache OR headache not relieved after two hours of OTC pain med; or other. The PLAN portion of the protocol provides the following treatment alternatives: For mild to moderate headache give: Acetaminophen 325mg two tablets every 4-6 hours as needed for pain, OR Ibuprofen 200mg two tablets every 6 hours as needed for pain Put patient in a quiet environment; recheck blood pressure in 15 minutes x2. Notify clinician if BP remains greater than 160/100. 1st blood pressure recheck: / , at . 2nd blood pressure recheck: / , at . Bed rest lay-in x24 hours Blood pressure recheck in 24 hours Return to clinic for BP check Pass Other Respondent was responsible for patient R.G.’s medical care at SCI and had access to all of R.G.’s medical records from SCI’s medical clinic. R.G. was a 61-year-old male inmate who presented to the clinic at SCI for treatment. On or about June 7, 2013, R.G. presented to SCI’s clinic with a blood pressure reading of 164/96, and complaining of a headache. R.G. was given 10 mg Lisinopril to reduce his blood pressure, a pass for three days of bedrest, and a follow-up appointment for June 10, 2013. The medical record entitled Hypertension Protocol does not contain Respondent’s name and he did not see R.G. that day. However, from the Physician’s Order Sheet, it appears that he was consulted and approved the administration of Lisinopril, and prescribed 10 mg of Lisinopril daily for three months. On June 9, 2013, R.G. presented at the clinic complaining about his blood pressure. The medical record notes that he had a headache. His blood pressure reading was 151/90, and the section entitled Findings Requiring Immediate Clinician Notification did not have any symptoms checked. The medical record does not indicate that Respondent saw R.G. on June 9, 2013, and he was not consulted about his care. The PLAN section of the Hypertension Protocol says “No treatment required.” On June 10, 2013, it appears that R.G. may have been seen at the clinic more than once. The initial entry in his medical records for that date, which does not have a time recorded, indicates that his blood pressure was 158/98. The second entry, recorded at approximately 2:00 p.m., indicates that R.G. presented to the clinic with a blood pressure reading of 173/98. Respondent ordered a one-time dose of .2 mg Clonidine, and 10 mg of Lisinopril and directed that his blood pressure be taken again in an hour. Respondent tried to find the underlying cause for the rise in R.G.’s blood pressure by sending him for blood work, and a thyroid and cardiovascular evaluation by the cardiac clinic. Respondent also directed that his blood pressure be checked twice weekly for an indecipherable number of weeks. When R.G.’s blood pressure was rechecked at approximately 4:00 p.m., it was 158/89. Respondent again ordered administration of 10 mg Lisinopril, increased his prescription for Lisinopril to 20 mg for three months, and ordered 600 mg of Ibuprofen to treat R.G.’s headache. R.G. next presented to the clinic on June 11, 2013, at 10:00 a.m. At that time, his blood pressure was noted as 152/94. There is no indication in the medical record that Respondent saw R.G. during that visit, and there is no documentation in the Physician’s Order Sheet to indicate that Respondent ordered any prescriptions for him. On June 18, 2013, R.G. went to the clinic complaining of a headache and vomiting. He listed his pain level at 6 out of 10. At his initial presentation at noon, his blood pressure was 197/105 in the left arm, and 186/86 in the right. Under the PLAN heading, the medical record indicates R.G. was given 200mg Ibuprofen for his headache, and 0.2 mg of Conidine for blood pressure. His blood pressure was rechecked at 1:00 p.m. and had lowered to 139/84. The medical record for June 18, 2013, does not indicate that Dr. Alaka saw R.G. or that he was consulted about him. The Department of Corrections Physician Order Sheet for R.G. has an entry dated June 18, 2013, but part of the record is indecipherable, and there is no doctor Signature/stamp completed for the entry. In addition, the portion of the entry that is readable refers to a Dr. Gonzalez, as opposed to Dr. Alaka. On June 20, 2013, R.G. returned to the clinic, this time complaining that he was stumbling and had a headache. A protocol sheet for Neurological Changes/Deficits was used in the medical records as opposed to the Hypertension Protocol. At this visit, his blood pressure was 120/62. There is no indication on the medical record for this date that Dr. Alaka saw R.G. R.G. returned to the clinic on June 25, 2013, at 5:39 p.m. The medical record indicates that he had a slight headache, a small amount of pitting/extremity swelling, fatigue, and had vomited that morning. His blood pressure was 165/94 in the left arm and 175/91 in the right. Pedal edema was noted to stop at the mid to upper shins, and the records indicate that R.G. had slept only three hours or less in the previous 24-hour period. R.G. was given acetaminophen for his headache, and his blood pressure was rechecked at 5:59 p.m. and 6:15 p.m.. His blood pressure at the first recheck was 165/94, and at the second recheck was 164/93. The Hypertension Protocol indicates that R.G. was administered 10 mg of Lisinopril, was instructed to comply with all prescribed medications, and not to sit with his legs crossed. The Physician’s Order Sheet indicates that per Respondent’s discussion with the nurse who saw R.G.,1 the prescription for 20 mg of Lisinopril was discontinued and replaced with a prescription for the same drug at 10 mg daily for three months. There was speculation throughout the hearing that R.G. did not always take his medications as prescribed, and there are notations in the medical records that R.G. sometimes refused recommended medical treatments, such as a referral for a urologist and a cardiac workup. There was no clear and convincing evidence that R.G. was also failing to take his blood pressure medications as required, although it is certainly a possibility. There is no indication in the medical records that R.G. went to the clinic for treatment after June 25, 2013.2 On July 2, 2013, R.G. was found unresponsive on the floor. He was transferred to ShandsLiveOak Regional Medical Center, and from there, transferred to Jacksonville Memorial on 1 The Administrative Complaint alleges that R.G. was seen by an ARNP during this visit. The signature of the health care provider indicates that he or she was an SRN, not an ARNP. The ARNP who reviewed the records and made what was referred to as an incidental entry (one where the record is reviewed but the patient is not seen) the following day is a different provider. 2 There is an entry for June 28, 2013, entitled Pre-Special Housing Health Assessment. Dr. Alaka testified he did not know what that meant. It appears from the record that the purpose of the assessment was to extend R.G.’s low bunk pass. At that time, his blood pressure was recorded as 158/92. It is not clear who conducted the assessment. July 3, 2013. R.G. died on July 5, 2013. The Medical Examiner’s Report lists R.G.’s cause of death as hypertension. Dr. Libert reviewed the medical records related to R.G.’s treatment. He opined that Respondent did not meet the applicable standard of care in his care and treatment of R.G. because he did not arrange for transportation to the hospital on June 18, 2013. He also opined that Respondent should have transferred R.G. on later dates prior to the transfer that occurred on July 2, 2013. He further opined that Respondent failed to recognize the signs and symptoms of malignant hypertension and failed to diagnose it. Dr. Libert also testified that Respondent failed to order basic blood tests that should have been ordered for a patient with hypertension. However, as noted above, Respondent did order blood work on June 10, 2013. There is no indication in the medical records that Dr. Alaka saw R.G. on June 18, 2013. With respect to the June 25 visit, Dr. Alaka would have received a phone call from staff, but did not see R.G. in person. Dr. Alaka has no independent recollection of seeing R.G., and had to rely solely on his review of the medical records for his account of what happened. The treatment of this patient occurred over eight years prior to the hearing in this case. Dr. Alaka did not believe that treatment in a prison setting is the same as the treatment rendered in a typical outpatient setting, and testified that in an outpatient setting, physician groups are free to set their own protocols. In a correctional setting, physicians were required to follow the protocols established by the Department of Corrections. Dr. Alaka testified that following the protocols was a condition of employment. Dr. Alaka testified that he did not create or maintain the medical records for patients at the facility, but would have access to the records when treating a patient. It is not clear, however, whether he had access to the records when he was not at the facility but received a telephone call regarding the treatment of a patient. Based upon the medical records in evidence, Dr. Alaka saw R.G. on June 10; was consulted about R.G. on June 7 and June 25; and was neither present nor consulted regarding R.G. on June 9, June 11, June 18, and June 20, 2013. The only time that the medical records indicate R.G.’s blood pressure may have been above the standard of 180/120 for malignant hypertension was June 18, 2013, and when rechecked, the pressure went down to 139/84. As noted above, the medical records do not indicate that Dr. Alaka either saw R.G. or was consulted about his care on that day. On June 25, 2013, R.G.’s blood pressure, while still considered high, was well below the standard identified for consideration of malignant hypertension. Dr. Alaka also testified that one must always consider the possibility of malignant hypertension when taking a patient’s blood pressure, but did not believe R.G.’s blood pressure reached that level. He tried to prevent it through the use of medication but did not believe that you needed to transfer a patient because of swelling, vomiting, or headache combined with high blood pressure, because those symptoms can occur with a variety of conditions. In his view, there should be concrete blood pressure readings, with indications of organ disturbance or stress. Organ damage would be substantiated through blood work and treated with medication while waiting for results. If the blood pressure is sustained, then he would call his supervisor and report the blood pressure; that it is not coming down; what medications were given; and request a transfer. He testified he did not request a transfer in this case because the blood pressure came down with treatment. In addition, Dr. Alaka noted that blood pressure readings can vary within the same hour, depending on who took the reading, the size of the cuff used, operator error, etc. Dr. Alaka also testified, credibly, that transfers to facilities outside the prison setting required approval by the regional medical director, and that was a condition for working at SCI. The Department did not provide any evidence to rebut the statement that Respondent did not have the authority to order transfer out of the facility, or that following the protocols reflected in the medical records was not required for employment at the facility. Dr. Alaka’s view of what blood pressure reading would have triggered a diagnosis of malignant hypertension is higher than Dr. Libert’s. Based on the evidence presented, Dr. Libert’s definition appears to be more reasonable. However, based on the totality of the evidence presented, the Department did not present clear and convincing evidence to show that Respondent’s care and treatment of R.G. violated the prevailing standard of care as alleged in the Administrative Complaint.
Conclusions For Petitioner: Hunter M. Pattison, Esquire Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 For Respondent: Edmond Olatunde Alaka, M.D., pro se 216 Elm Drive Chattahoochee, Florida 32324
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against Respondent be dismissed. DONE AND ENTERED this 20th day of December, 2021, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2021. COPIES FURNISHED: Hunter M. Pattison, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Edmond Olatunde Alaka, M.D. 216 Elm Drive Chattahoochee, Florida 32324 Paul A. Vazquez, JD, Executive Director Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399
