The Issue The issue for consideration is whether Respondent, Sarasota County Public Hospital Board's, (Board), Motion To Dismiss HCA of Florida, Inc.'s (Doctors), Petition For Formal Administrative Proceedings should be granted.
Findings Of Fact On June 26, 1990, the Board filed CON application No. 6347, seeking approval to construct a comprehensive outpatient center and medical office complex on the campus of Sarasota Memorial Hospital. The new facility, anticipated to have a cost of slightly in excess of $18,000,000.00, was to house several outpatient functions including: outpatient registration outpatient diagnostic radiology outpatient laboratory services outpatient rehabilitative services outpatient cardiology diagnostic center outpatient dialysis Health resources center, and an office building located adjacent to the existing ambulatory surgical center. On or about July 13, 1990, the Department of Health and Rehabilitative Services, (Department), issued its State Agency Action Report, (SAAR), in which it indicated a preliminary decision to approve the subject application in its entirety, designating the project reviewable under Section 381.706(2)(d), Florida Statutes. Notice of this decision was published in the Florida Administrative Weekly on August 3, 1990. On August 14, 1990, Doctors filed a Petition For Formal Administrative Hearing challenging the preliminary approval, claiming that components of the project are reviewable under several subsections of Section 381.706(1), Florida Statutes. Specifically, Doctors claims that the operation of a home health agency from the complex renders it reviewable under subsection (f); that as the project constitutes a substantial change in the provision of inpatient services, or establishes new inpatient services, it is reviewable under subsection (h); and that it is an additional health care facility which is reviewable pursuant to subsection (b). Doctors also claims the new facility will hurt its ability to compete for patient referrals from physicians who will be housed in the new facility and will result in a reduction of Doctors' market share. Doctors is an existing hospital that provides a full range of acute care services to residents of Sarasota County. The Board's application contends that the development of this complex will free up capacity in key ancillary areas to better accommodate patients, and it is so found. The ambulatory diagnostic and treatment space proposed for the new facility represents what would have otherwise been less efficient additions to the existing departments. There will also be a bridge connecting the main hospital to the new center which will provide convenient access to any outpatient who may need to visit the hospital. It will also provide, "... direct linkage between the acute inpatient facility with the physicians' offices thereby enhancing pertinent access to a range of diagnostic and treatment services." Doctors contends in its Petition that it is the Board's clear intention and expectation to increase its service area and market share of Sarasota County patients as a result of this project. It asserts that if the Board's project is implemented, it will be serving different patients, and a different patient mix from a different geographical area than currently served. For the purpose of resolving the limited issues at this motion hearing, these assertions are accepted as fact. Accepting the assertions in paragraph 5 through 7, above, as fact, however, does not necessarily require the conclusions be reached that the accomplishment of the Board's project would result in any significant change to the level of its patient service since what is planned deals only with outpatient services. While Doctors disputes this, its claims that inpatient services would be effected is not supported.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore RECOMMENDED that the Secretary, Department of Health and Rehabilitative Services, enter a Final Order dismissing HCA of Florida, Inc.'s Petition in opposition to the grant of CON No. 6347 to the Sarasota County Public Hospital Board. RECOMMENDED this 15th day of October, 1990, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 15th day of October, 1990. COPIES FURNISHED: Robert A. Weiss, Esq. Parker, Hudson, Rainer & Dobbs The Perkins House 118 N. Gadsden Street Tallahassee, Florida 32301 John Radey, Esq. Elizabeth McArthur, Esq. Aurell, Radey, Hinkle & Thomas Suite 1000, 101 North Monroe Street Post Office Drawer 11307 Tallahassee, Florida 32302 Edward G. Labrador, Esq. Department of Health and Rehabilitative Services 2727 Mahan Drive, Suite 103 Tallahassee, Florida 32308
Findings Of Fact THE PARTIES Petitioner, Englewood Community Hospital, Inc., d/b/a Englewood Community Hospital (Englewood), is a 100 bed general acute care hospital located in Englewood, Florida. Englewood is owned and operated by Columbia/HCA Health Care (Columbia), a for-profit corporation. Englewood operates an outpatient cardiac catheterization laboratory in a mobile unit located in the hospital parking lot. Patients and some physicians have been reluctant to use the mobile unit. Venice Hospital, Inc. (Venice) is a not-for-profit, community owned hospital with 342 beds. Venice operates an inpatient cardiac catheterization laboratory for invasive cardiac diagnostic procedures. Venice has unsuccessfully applied twice for a certificate of need (CON) to provide open heart surgery. The Sarasota County Public Hospital Board (Sarasota Hospital Board) is a publicly elected, nine member organization, which is responsible for the operation and oversight of Sarasota Memorial Hospital (Memorial). Memorial is a 952 bed hospital with services including inpatient cardiac catheterization and open heart surgery. Memorial is located in Sarasota, Florida. Englewood, Venice, and Memorial are all located in Sarasota County which is in the Agency for Health Care Administration Planning District 8. There are nine other inpatient cardiac catheterization programs in District 8. The existing inpatient cardiac catheterization programs are distributed as follows: Sarasota County (3); Charlotte County (3); Lee County (4); Collier County (1). Respondent, Agency for Health Care Administration (Agency), is the state agency which administers CON laws in Florida. The Agency published on February 4, 1994, a fixed need pool projection for inpatient cardiac catheterization procedures, showing a need for three additional programs in District 8 for the batch in which Englewood's application was reviewed. This calculation counted an earlier application of Englewood as approved. THE PROJECT Englewood proposes to establish an adult inpatient cardiac catheterization laboratory, placing inside the hospital facility the equipment which is currently located in its mobile cardiac catheterization laboratory. Englewood timely filed the letter of intent, CON application, and response to omissions for CON Number 7663. The Agency originally denied the application because a previous application by Englewood for inpatient cardiac catheterization services had been granted. The previous application proposed to keep the equipment in the mobile unit and build a walkway from the mobile unit to the hospital facility. Englewood withdrew its application for the previous application. The Agency has filed an official notice of changing its position to support Englewood's CON Application Number 7663. NEED FOR THE PROJECT IN RELATION TO THE LOCAL AND STATE HEALTH PLANS The 1993 Florida State Health Plan provides four allocation preferences relevant to the review of the certificate of need applications to establish adult inpatient cardiac catheterization programs. Preference shall be given to an applicant who proposes the establishment of both cardiac catheterization services and open heart surgical services provided that a need for open heart surgery is indicated. Preference shall be given to an applicant proposing to establish a new cardiac catheterization program if the applicant can demonstrate that patients are currently seeking cardiac catheterization services outside the respective county or HRS district. Preference shall be given to hospitals with a history of providing a disproportionate share of charity care and Medicaid patient days in the respective acute care subdistrict. Qualifying hospitals shall meet Medicaid disproportionate share criteria. Preference shall be given to an applicant who agrees to provide services to all patients regardless of their ability to pay. Englewood has projected that charity and indigent care for cardiac catheterizations at less than 1.0 percent of total revenue. Given Englewood's past history, 1.0 percent of total revenue is a gross overstatement. At the final hearing, Englewood stated that it would not agree to condition the CON on Englewood providing charity and indigent care equal to 1.0 percent of the total revenue. The Agency's 1992 Hospital Financial Data showed that Englewood's reported charity and uncompensated care was approximately .09 percent and .06 percent of total revenues for fiscal years 1992 and 1993, respectively. Englewood has agreed to provide adult cardiac catheterization services to anyone in need without ability to pay; thus, Englewood is entitled to a partial preference for providing services to patients regardless of their ability to pay. Englewood has not demonstrated that it should receive a preference for the other three factors. The 1993 District 8 Allocation Factors Report addresses the following preferences relevant to the review of certificate of need applications to establish adult inpatient cardiac catheterization services. Preference shall be given to applicat- ions for new or expanded cardiac catheterization services that clearly indicate the impact of the proposed services on other health providers offering similar services in the same area. Preference shall be given to applicants which agree to provide services to all patients, regardless of their ability to pay. Englewood has agreed to provide services to all patients without ability to pay and is entitled to a partial preference for the second factor in the district plan. AVAILABILITY, QUALITY OF CARE, EFFICIENCY, APPROPRIATENESS, ACCESSIBILITY, EXTENT OF UTILIZATION, AND ADEQUACY OF LIKE EXISTING HEALTH CARE SERVICES IN THE SERVICE DISTRICT. Englewood's proposed inpatient cardiac catheterization program would not adversely affect the quality of care provided by the cardiac catheterization programs at Sarasota Memorial Hospital and Venice Hospital. Memorial has a comprehensive cardiac catheterization program. It operates three dedicated cardiac catheterization laboratories. The Memorial laboratories provide diagnostic catheterizations as well as all available therapeutic catheterization techniques. Prior to performing a diagnostic catheterization, cardiologists are able to determine with a high degree of confidence and reliability whether a patient with cardiovascular disease will require, during a particular hospitalization, therapeutic intervention, e.g. angioplasty or open heart surgery. Cardiologists rely on an array of sophisticated non-invasive diagnostic tests in making such determinations. When a cardiologist determines that a patient is not sufficiently ill to require therapeutic intervention, the patient will customarily receive a diagnostic catheterization on an outpatient basis. During the last several years, there has been a shift in Sarasota County from inpatient catheterization to outpatient catheterization. In fact, the Medicare program requires that Medicare patients receive outpatient catheterization, unless a patient's medical condition requires inpatient care. Normally only patients with unstable medical conditions receive inpatient cardiac catheterization. That group of patients is likely to require therapeutic intervention during the same hospital admission to resolve their medical problems. Between 80 to 90 percent of patients who receive inpatient cardiac catheterization receive therapeutic intervention during the same hospital admission. If an unstable patient presents at a facility which lacks the capability to perform therapeutic intervention, it is in the best medical practice to stabilize the patient and then transfer the patient to a facility which can perform both the diagnostic catheterization and the therapeutic intervention. If the unstable patient requires intervention in the form of angioplasty, it is in the patient's best interest to receive both the diagnostic and therapeutic procedures during a single visit to the cardiac catheterization laboratory. The provision of both procedures in one visit enhances comfort, safety, and efficiency. It is Memorial's practice to provide both types of services in one visit to the catheterization laboratory when possible. Adult inpatient cardiac catheterization programs are available within a maximum automobile travel time of one hour, under average travel conditions, for at least 90 percent of District 8's population. The Sarasota Hospital Board's policy is to provide cardiac catheterization services at Memorial to all residents without regard to their ability to pay. In its most recently completed fiscal year at the time of the final hearing, the Sarasota Hospital Board provided $268,000 of charity care and $720,000 of Medicaid care, related to cardiac catheterization patients. In its application, Englewood stated: "There is no evidence to indicate that the efficiency, appropriateness and adequacy of adult inpatient cardiac catheterizations services in District VIII are less than adequate." Each of the seven hospitals in Sarasota and Charlotte Counties, with the exception of Englewood, operate an adult inpatient cardiac catheterization laboratory. There is excess capacity at the existing cardiac laboratories in Sarasota and Charlotte Counties. A single cardiac catheterization laboratory can safely perform approximately 1500 cases annually. Three of the existing cardiac catheterization laboratories in Sarasota and Charlotte Counties operate a volume between 300-400 cases annually: Fawcett, St. Joseph's, and Doctors'. Fawcett is owned and operated by Columbia. Venice operates the existing laboratory closest to Englewood. Venice's catheterization laboratory has the capacity to perform 1,500 procedures annually. Over the last five years, the number of cases has grown from 500 to approximately 800, where it has leveled off, leaving almost half the laboratory's capacity unused. Venice's catheterization laboratory is available and accessible to Englewood residents. The catheterization laboratory at Venice has been serving Englewood patients and will continue to do so. Venice currently serves a significant share of the market in three of the six zip codes identified by Englewood as its service area. There is adequate capacity at the existing laboratories in Charlotte and Sarasota Counties to treat the existing volume of cardiac catheterization patients, as well as the volume that Englewood proposes to serve. Patients in the Englewood area will not experience serious problems in obtaining inpatient cardiac catheterization services in the absence of Englewood's proposed program. Under these circumstances it is more appropriate and less expensive to the health care system as a whole to fully utilize existing catheterization laboratories. ABILITY OF APPLICANT TO PROVIDE QUALITY CARE AND APPLICANT'S RECORD OF PROVIDING QUALITY OF CARE Englewood has a record of providing appropriate quality of care to its patients. Englewood is fully accredited by the Joint Commission on Accreditation of Health Care Organizations. Englewood submitted a written protocol for transfer of emergency patients to a hospital providing open heart surgery within 30 minutes travel time by emergency vehicle under average travel conditions as part of its application. Englewood's cardiac catheterization program policies and procedures manual is appropriate. The equipment which Englewood proposes for its inpatient cardiac catheterization laboratory was purchased from Southwest Florida Regional Medical Center in Fort Myers, Florida, where it had been used successfully for approximately one year. The equipment is currently being used in Englewood's outpatient cardiac catheterization laboratory. The equipment uses analog imaging, and includes video playback to allow instant review. Digital imaging is newer technology than analog imaging and allows the image of the cardiac areas to be magnified, processed and measured while the physician is performing the catheterization. Regardless whether analog or digital imaging is used the physician will rely on a 35mm film which is made during the catheterization procedure to make the diagnosis. The digital imaging equipment is more expensive than the analog imaging equipment. Although, digital imaging is nice to have, it is not necessary to provide quality cardiac catheterization services. Englewood has plans to move the outpatient cardiac catheterization laboratory from the mobile unit to inside the hospital facilities. As of the date of the final hearing, Englewood had not begun construction of this project to relocate the outpatient laboratory. The cost of renovating space for the cardiac catheterization laboratory and moving the equipment inside is estimated to be $400,000. Two or three people are required to assist the physician perform an inpatient cardiac catheterization. One person circulates, moving outside the sterile area surrounding the procedure table to get medications, log information and generally oversee and monitor the patient's condition. The staff should include cardiovascular technicians, who may be but do not have to be nurses. Englewood proposes the following staffing and salary: FTE'S YEAR 1 HOURLY RATE SALARIES FTE'S YEAR 2 HOURLY RATE SALARIES RNS 3.0 19.92 118,061 5.0 19.68 204,672 Nurse Manager 1.0 0 1.0 0 Cath Lab Tech 2.0 14.43 60,029 2.0 15.01 62,442 Subtotal 6.0 178,090 8.0 267,114 Lab Director 1.0 0 1.0 0 Subtotal 1.0 0 1.0 0 Unit Secretary 0.5 7.96 8,278 1.0 8.28 17,222 Subtotal 0.5 8,278 1.0 TOTAL 7.5 186,368 10.0 284,336 The radiology technician's job is to assist with quality assurance, help maintain and oversee the equipment, and monitor safety. The radiology technician does not have to be present in the laboratory during procedures. Englewood already employs a radiology technician in its radiology department. This technician has had training for cardiac catheterization laboratory duties. Dr. DeGuia currently performs the duties of a medical director and will continue to do so if the inpatient laboratory is established. The nurse manager who is currently employed as the nursing manager for the intensive care, progressive care and outpatient will be utilized in the inpatient laboratory as well. The staff will be cross trained in each position's functions. Englewood will have the assistance of Fawcett Memorial Hospital and Southwest Heart Institute in staffing and training when needed. Englewood's proposed staffing will provide an adequate number of properly trained personnel. The salaries Englewood proposes to pay its staff are reasonable and competitive. UTILIZATION In its application, Englewood projects that the first year of operation of the inpatient laboratory, there will be a total of 236 cardiac catheterizations performed consisting of 132.9 inpatients and 103.1 outpatients. In the second year of operation, Englewood projects the total cardiac catheterizations to be 345 with 194.3 being inpatient and 150.7 being outpatient. Englewood has included six specific zip code in its service area. Based on Englewood's experience with MDC 05 diagnoses1, Englewood's expert witness Scott Hopes opined that Englewood's market share for diagnostic cardiac catheterization services would be as follows: ZIPCODE MARKET SHARE 33947 53.1 percent 33981 43.8 percent 34223 50 percent 34224 65.2 percent 34287 6.4 percent 34293 2.0 percent In order to project inpatient utilization of the Englewood laboratory, it is appropriate to rely upon the historical pool of patients in the Englewood service area who have received inpatient catheterization during a hospital admission, without receiving angioplasty or open heart surgery during that admission. Englewood proposes to serve primarily "low risk" inpatients who are not expected to require intervention during that hospital admission. For the period July 1991 through June 1992, there were 490 inpatient cardiac catheterizations performed on patients residing in Englewood's service area. For the period July 1992 through June 1993, there were 479 inpatient cardiac catheterizations performed on patients in the same service area. In its application, Englewood applied an aggregate market share to the total number of inpatient cardiac catheterizations performed on the residents of the proposed service area. This method distorts the projected number of inpatient procedures which could be performed by Englewood because of the variability of the market shares in each zip code. Based on the method employed in Englewood's application, Englewood would have performed 145 and 160 inpatient cardiac catheterizations in the 1991-1992 and 1992-1993 periods, respectively. When one applies the actual market share by zip code to the actual number of procedures performed on patients from each zip code, a more accurate projection based on historical data can be made as shown in the chart below. ZIP CODE MARKET SHARE 1991-1992 CATHS ENGLEWOOD SHARE 1992-1993 CATHS ENGLEWOOD SHARE 33947 53.1 percent 21 11 18 10 33981 43.8 percent 35 15 29 12 34223 50.0 percent 68 34 72 36 34224 65.2 percent 42 27 34 22 34287 6.4 percent 145 9 146 9 34293 2.0 percent 179 4 180 4 100 93 Englewood performed 50 outpatient cardiac catheterizations in 1994. This low utilization is based on the physical location of the outpatient facility in the hospital parking lot and the lack of marketing. Fifty procedures is not a representative number of the outpatient procedures which Englewood could expect if the laboratory was located inside the hospital and the program was marketed effectively. The application states that in 1992 the percentage of inpatient cardiac catheterization procedures of the total cardiac catheterizations performed in hospitals with an inpatient program in District 8 was 56.33 percent.2 Thus based on Englewood's market share by zip code, the total amount of cardiac catheterizations which Englewood could have expected in 1991-1992 and 1992-1993 would have been 177 and 165, respectively. In its application, Englewood uses three different methodologies to project the number of cardiac catheterizations Englewood could expect during its first and second year of operation. Method 1 (pgs. 28 and 32 of the Response to Omissions) subtracts the amount of catheterizations Englewood would have expected in 1991-1992 from the amount it would have expected in 1992-1993 and increases the projection each year by this amount to project the number of catheterizations for the first two years of operation. Using Method 1 would result in a decrease in the number of cardiac catheterizations each year because the number of cardiac catheterizations declined by 12 procedures from 1991-1992 to 1992-1993. Method 2 (pgs. 30 & 32 of the Response to Omissions) employs an annual increase of 8 percent. This increase is the lowest annual percentage increase of cardiac catheterizations in District 8 from October 1987 to September 1993. Using this method would result in a projection of 208 procedures for 1996 and 224 procedures for 1997. Method 3 (pgs. 31 & 32 of the Response to Omissions) uses a 12.78 percent annual increase based on the average annual percentage increase of cardiac catheterizations in District 8 from October 1987 to September 1993. Using this method would result in a projection of 237 procedures for 1996 and 267 procedures for 1997. Using any of the three methods to project the number of procedures to be performed in the second year, Englewood will not perform a minimum of 300 catheterization procedures by the end of the second year of operation of the inpatient laboratory. The Intermedic Health Center is a large multi-specialty group with a five cardiologist heart group based in Port Charlotte. Intermedic has offices in Englewood. The heart group was to begin regular office schedules in Englewood in February, 1994. The group plans to recruit one or two additional physicians to staff the office. At the time of final hearing the physicians of Intermedic's heart group performed cardiac catheterizations at hospitals other than Petitioner's because some of the cases were inpatient and some of their outpatients were uncomfortable with a portable laboratory. For 1995, Intermedic projected 90 to 100 cases; thereby resulting in some increase in business with Englewood relating to cardiac catheterizations. The population in the Englewood service area consists of a large number of residents who are 65 or older. This segment of the population is more likely to have a high demand for cardiac catheterization than a younger segment of the population. The 65 or older category is a fast growing part of the population in the Englewood service area. IMMEDIATE AND LONG-TERM FINANCIAL FEASIBILITY OF THE PROGRAM Englewood has the financial ability to fund the construction of the project. The pro forma statement contained in the CON application is flawed. Englewood has double counted a profit layer that it is already enjoying from inpatients that it transfers to an inpatient catheterization provider. Englewood does not account for the contribution margin attaching to Englewood's inpatient portion of their care before transfer. In projecting its revenues from outpatient utilization, Englewood has included in its figures outpatient catheterizations it would perform whether or not its application is approved rather than basing their pro forma on the incremental difference attributable to approval of an inpatient program. The projected revenues contained in the pro forma are suspect. First, the proposed procedure charges shown on the outpatient service revenues page of Englewood's application are high. It is unusual to find outpatient procedure charges that are higher than the inpatient procedure charges. In Table 7 in the application, Englewood asserts that patient days for Medicaid and private pay will net the highest revenues per patient day. Typically those two payor sources are at the bottom of the list of revenue producers than the top. Englewood's pro forma understates revenue deductions by assuming Medicaid and private pay reimbursement that is unrealistic and by failing to take into account anticipated growth in managed care. Englewood's financial expert agreed that managed care will see significant growth over the next five years. Because the pro forma overstates net revenue, it understates revenue deductions. Englewood has understated expenses. The marginal cost per case is understated, relocation expenses are understated, and the nurse manager's time is not allocated to the expense side of the pro forma. The State Agency Action Report also calls into question the adequacy of the expenses in Englewood's pro forma.3 Based on the flawed pro forma, Englewood has not demonstrated that the project is financially feasible. OTHER STATUTORY CRITERIA The costs and methods of the proposed construction, including consideration of the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction are reasonable. The proposed design of Englewood's inpatient cardiac catheterization laboratory is reasonable and appropriate. Englewood submitted the list of capital projects required by Section 408.037(2)(a) and (b), Florida Statutes (1993); the audited financial statements required by Section 408.037(3), Florida Statutes (1993); and the resolution required by Section 408.037(4), Florida Statutes (1993). I. STANDING OF VENICE AND MEMORIAL If Englewood were to establish an inpatient cardiac catheterization laboratory, both Venice and Memorial would have patients diverted from their programs to Englewood's. Based on the projections contained in Englewood's application, Venice would lose 82 catheterization procedures in the second year of operation of Englewood's proposed program, resulting in a net profit lose of $234,000. Although Englewood's application projections are inaccurate, the application does contemplate that Venice would lose procedures as a result of the implementation of Englewood's proposed program. In order for Englewood to reach its projected volume of procedures, approximately 40 to 50 procedures would have to be redirected annually from Memorial to Englewood. There is also a strong potential that Memorial would lose angioplasty and open heart surgery cases as well. Southwest Florida Regional Medical Center (SWFRMC), in Fort Myers, is owned by Columbia. It is a tertiary cardiovascular referral center for other Columbia hospitals in Southwest Florida. The development of an inpatient cardiac catheterization laboratory at Englewood would assist in the development of referral patterns from the Englewood area to SWFRMC for angioplasty and open heart surgery. It would be in Columbia's interest to encourage utilization of SWFRMC's cardiovascular services by patients residing in the Southwest Florida area.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying the application of Englewood Community Hospital, Inc., d/b/a Englewood Community Hospital's for Certificate of Need 7663 to establish an adult inpatient cardiac catheterization program. DONE AND ENTERED this 18th day of December, 1995, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND, 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 18th day of December, 1995.
Findings Of Fact Based upon the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner's facility opened in January of 1976 as the Hubert Rutland Hospital. Its name was subsequently changed to Gateway Community Hospital and, after purchase by petitioner, it became Humana Hospital Northside. Dr. D. K. Mukherjee, Board-certified in internal medicine and cardiology, came to petitioner's facility in 1976 for the prime purpose of developing a cardiac catheterization laboratory, and assisted in preparing a list of equipment necessary to begin operation of such a laboratory. On December 31, 1976, petitioner's predecessor entered into a medical equipment service agreement for cardiac catheterization and monitoring equipment. That equipment, costing less than $100,000.00, was delivered to the hospital on or before June 17, 1977. Since that time, cardiac catheterization procedures, as defined in Rule 10-5.11(15), Florida Administrative Code, have been performed on a continuous and regular basis at petitioner's facility in Special Procedures Room No. 3. Over the past eight to nine years, the longest interval between the performance of such procedures has been approximately one or two weeks. Special Procedures Room No. 3, while also utilized for other purposes, has the equipment, staff and support services necessary for providing the studies and procedures associated with cardiac catheterization. The hospital itself is capable of providing the ancillary diagnostic services, such as hematology studies, electrocardiography, chest x-rays, blood-gas studies, pathology, blood chemistry analysis and nuclear studies pertaining to cardiology. Prior to July 1, 1977, Certificate of Need review was not required for the purchase of cardiac catheterization equipment by a hospital unless it involved a capital expenditure of more than $100,000.00. Commencing on July 1, 1977, Certificate of Need review was required when a health care facility sought to provide a substantial change in service, defined as a service which was not offered on a regular basis within the prior twelve-month period. Section 381.494(1)(c), Florida Statutes, and Rule 10-5.02(19), Florida Administrative Code. Because of technological and scientific advances, petitioner desired to replace and update the equipment purchased in 1976 for the performance of special procedures. Accordingly, in April of 1984, it submitted an application for a Certificate of Need to replace special procedures equipment at a project cost of $1,269,000.00. The application, in Section 3 stating the need and justification for the project, noted that: "Our existing equipment is totally inadequate to perform state-of-the-art cardiac catheter- ization and coronary angioplasty. When we began performing cardiac catheterization in 1977 this equipment was adequate, but today it is totally unacceptable. This proposed equipment will not only provide state-of-the- art equipment for these procedures, but will do so in a cost-effective manner since combined utilization of such high cost equip- ment contributes to the reduction of the cost of medical care." HRS issued petitioner Certificate of Need number 3261 for the replacement of special procedures equipment at a total project cost of $1,269,000.00, as requested. However, in a cover letter transmitting the issued Certificate of Need to the petitioner, HRS noted: "Please be advised that neither this office, the Office of Licensure and Certification nor the Local Health Council has documen- tation to support the performance of cardiac catheterization procedures at this hospital." Local Health Councils are private nonprofit corporations which contract with HRS to conduct local planning activities, including the collection of data, the publication of various utilization reports and the development of Local Health Plans. When HRS reviews proposed health care projects which require a Certificate of Need, it utilizes the data submitted to it by the various Local Health Councils, particularly in those instances where its rules contain a methodology or formula which includes as a factor an accounting of existing facilities or services. Application of the methodology contained in HRS's rule for determining the need for additional cardiac catheterization laboratories requires a knowledge of the number of procedures performed per year by existing and approved laboratories. Rule 10-5.11(15), Florida Administrative Code. The Health Council of Pasco/Pinellas, Inc. collects data from hospitals within Pasco and Pinellas Counties regarding bed utilization and service information. Hospitals in the district are requested to complete and submit certain information on a "Monthly Hospital Utilization Form." Among the items of information requested is the number of cardiac catheterization procedures performed during the reporting period. The Health Council also publishes and distributes annual and semi-annual utilization reports for the district. There is no provision in the statutes or rules which require hospitals to report utilization or service data to the various Local Health Councils, and HRS itself does not require that such information be reported to it. It is not unusual for hospitals to report inaccurate, incomplete or inconsistent data to Local Health Councils. Indeed, it is recognized in the "1984 Annual Hospital Utilization Report for District V Pasco/Pinellas Health Council, Inc." that, while all hospitals in the District submitted monthly hospital utilization information, "One limitation to this report involves those institutions who did not, for various reasons, submit data for beds by service categories and/or data pertaining to specialty services." HRS Exhibit F, p. 1. The form utilized by the Pasco/Pinellas Health Council contains no definition of cardiac catheterization procedures and no directions as to how to complete the form. While it has regularly submitted a monthly utilization form to the Local Health Council, petitioner has never reported the performance of cardiac catheterizations at its facility. The various reports published by the Local Health Council do not list petitioner as performing cardiac catheterization procedures. While a health care facility may obtain a written determination from HRS that a given service is exempt from Certificate of Need review due to its "grandfathered" status, there is no agency rule or policy which requires a facility to obtain such a written exemption. It has generally been the agency policy that equipment and services acquired by a facility prior to the date that such acquisition became reviewable under the Certificate of Need law are not reviewable on a retroactive basis.
The Issue The issue for consideration in this hearing is whether the Intervenor, St. Joseph Hospital of Port Charlotte, should be issued Certificate of Need #6202 for the establishment of a cardiac catheterization laboratory at its facility in Port Charlotte, Florida.
Findings Of Fact At all times pertinent to the issues herein, the Department was the state agency responsible for the regulation and certification of health care facilities in this state and charged with the responsibility of issuing Certificates of Need, (CON), under the criteria set forth in Section 381.705 Florida Statutes and the Department's Rules. St. Joseph Hospital is a 212 bed general acute care hospital located in Port Charlotte, Florida, within the jurisdiction of the Department's District VIII. It is a not for profit, tax exempt corporation owned by Bon Secours Health Systems, a multi-hospital system. It offers varied medical and surgical services, including obstetrics and pediatrics, and operates a 24 hour emergency room. The facility is accredited by the Joint Commission on Accreditation and Health care Organization, and its laboratory is accredited by the American College of Pathology. Because St. Joseph opened a nursing home in Port Charlotte in 1975, Chapel Manor Nursing Home, Fawcett's predecessor, and at that time, the only nursing home in Port Charlotte, applied for and was issued a CON to convert from a nursing home to an acute care hospital and began operation as Fawcett Memorial Hospital that year. Fawcett is now a 254 bed general medical surgical acute care hospital providing a broad range of services with the exception of obstetrics and pediatrics, and is located directly across the street from St. Joseph. It offers diagnostic cardiac catheterization service only, implementing that service in August, 1989. Both Fawcett and St. Joseph have the same service area and utilize the same physicians on their medical staffs, which are practically identical. St. Joseph offers a full array of cardiology services with the exception of cardiac catheterization. As a result, any St. Joseph patient requiring cardiac catheterization must be discharged from St. Joseph and transferred to another hospital in the area which provides that service. Between January 1989 and February, 1990, approximately 97 St. Joseph patients required transfer because of the fact that St. Joseph had no pertinent program. Because of this fact, and recognizing that the Department had determined there was a numeric need for an additional cardiac catheterization lab within the district, specifically based on the under-served indigent and Medicaid patients, in February, 1990, St. Joseph submitted a letter of intent to file a CON application for the establishment of an adult inpatient cardiac catheterization laboratory at its facility in District VIII. This letter of intent was based on proper Board Resolution, and was filed not only with the District but also with the local Health Council, and the required notice was published in a local paper. Thereafter, in March, 1990, St. Joseph filed its CON application for the facility, along with the appropriate fee, with the Department, at the same time filing a copy with the local Health Council. The Department responded with an omissions letter, the requirements of which were met by St. Joseph in a timely manner, and the Department thereafter deemed the application complete. Notwithstanding Fawcett's allegations in the post hearing submission that St. Joseph's application was not complete, there was no evidence presented at hearing to so establish, and the Department deemed it both timely and ultimately complete. On on about July 17, 1990, the Department issued its State Agency Action Report and notified St. Joseph of its decision to approve the application. Approximately one month later, in a timely fashion, Fawcett filed its Petition challenging the Department's approval of St. Joseph's application. St. Joseph projects implementation of service by the unit in December, 1992. The unit will encompass approximately 3,800 square feet and will be part of and companion to a larger construction project designed to expand St. Joseph's surgical capacity. It will be located in a proposed two-story addition to the south side of the existing hospital. Total cost of the project, including construction of the building and equipment, is estimated to be approximately $2.6 million, one hundred percent of which will be financed by debt. It is estimated that interest costs over the term of the financing will be an additional $2.25 million. St. Joseph anticipates the charge for a cardiac catheterization will be $6,657.48 in 1993, and $7,123.50 in 1994. This is the same as the average charge for the procedure by existing providers in the district, adjusted for inflation in later years. The facility will be open routinely from 7:00 AM to 2:30 PM, Monday through Friday. An on-call team will, however, be available 24 hours a day although cardiac catheterization, usually an elective procedure, should not require much in the way of emergency services. Dr. Victor Howard, a Board certified internist and cardiologist, who is already on staff at St. Joseph, is projected to be the medical program director for the new facility without additional compensation. Cardiac catheterization is a relatively new diagnostic and therapeutic invasive procedure which involves the insertion of an extremely fine hollow tube through a blood vessel in the groin, up into the patient's heart. Because the patient faces danger from collateral problems such as bleeding, stroke, congestive heart failure and medication reactions, at least three staff members are required to assist the physician performing the catheterization. As with most procedures, the more it is done, the more proficient the individuals doing it become. By the same token, the medical staff assistants to the physician in charge must have specialized skills and training, and the Department rules require that in order to properly provide for therapeutic catheterization patients, an open heart surgery facility must be available within thirty minutes of the facility where the catheterization is being carried out. St. Joseph intends to rely on Medical Center Hospital in Punta Gorda, approximately ten miles away, as the required backup open heart facility. Medical Center is within the maximum thirty minute drive time criteria. It provides not only an open heart surgery program but also both diagnostic and therapeutic cardiac catheterizations. Diagnostic catheterizations, as opposed to therapeutic catheterizations, can be done on an outpatient basis. Experience has indicated that staff assistant technicians, nurses and others, are frequently not reasonably available. As a result, there is continuing competition between hospitals providing the services requiring these individuals, and this competition is often severe. Nonetheless, Fawcett has, up to the present, been able to recruit and retain adequate numbers of experienced personnel without the necessity for paying a bonus over and above normal salary. By the same token, St. Joseph believes it, too, will be able to attract and retain sufficient numbers of qualified personnel to successfully operate its laboratory as approved. At the present time, St. Joseph has ten registered nurses on staff who have cardiac catheterization laboratory experience. The laboratory, if approved, will not open at St. Joseph until the second half of 1992. At that time, manpower requirements for the project call for 3.36 full time employees, (FTE's), and that number appears capable of being satisfied by the current staff, though a cardiovascular technician, (CVT), has not yet been hired for the lab. In addition, St. Joseph appears to have on hand adequate management and supervisory personnel. It projects salary and benefits expense of almost $140,000.00 in 1993 and almost $150,000.00 in 1994. Maintenance expense is expected to approximately $65,000.00 the second year of operation. The proposed project has been enthusiastically received by the medical community in the service area. Because, in that area, the treating physician determines where the patient will be treated, support for the project by the area cardiologists is important as a positive factor for consideration. Because it has both the financial and personnel resources to provide the service, access to the service will be improved for the medically indigent and the facility's current cardiology program will be enhanced. The Florida legislature has, by its passage of Section 381.705, Florida Statutes, laid the basic analytical framework to be used in determining whether the facility here in question is needed. Consistent with the terms of the enabling statute, the Department has promulgated Rule 10-5.011, F.A.C., to implement the provisions of the statute. The rule formula provides a showing of "need" if at least 300 procedures could be performed by the new program, based on the total number of catheterizations, diagnostic and therapeutic, projected for the District. Projections for Charlotte County alone indicate 180 additional catheterizations between 1989 and 1994. Consistent therewith, the Department has determined that within DHRS District VIII, the pertinent service district, there is a numeric need for one additional cardiac catheterization laboratory. Need, however, goes beyond the question of numeric need. It is also a factual issue that requires an analysis of health planning principles and standards used within the ultimate goal of providing the best quality medical care for the citizens of this state in a sound, economically justified manner. In that regard, it is appropriate to evaluate need with an eye that looks toward avoiding unnecessary and costly duplication of services that are unnecessary. Fawcett contends there is no need for an additional lab in District VIII, based on the underutilization of existing programs. The Department's rule, the use of which resulted in a determination of need for one additional unit, does not regulate capacity. District VIII consists of Sarasota, DeSoto, Glades, Hendry, Charlotte, Lee, and Collier Counties. Sarasota and Lee Counties each have three cardiac catheterization programs while Collier has one in its only hospital. Charlotte County has two, Fawcett and Medical Center. It has already been noted that Fawcett and St. Joseph are located across the street from one another. Medical Center, which is used for therapeutic catheterizations, is located not far from the other two, and all three are Medicaid providers. All three also serve generally the same service area and use, essentially, the same medical staff. Moreover, the three facilities' cardiology staffs are essentially identical. When evaluating the service availability, however, it must be noted that Charlotte County experienced the highest relative increase in population among all the District VIII counties during the decade of the 1980's, and projections are that it will continue to lead up through 1995. At the present time, Charlotte County has the highest percentage of residents over age 65, (34%), of any of the District VIII counties. Looking at the proposed service in light of the pertinent State Health Plan, that for 1989, four preferences should be considered when evaluating the need for the proposed service. One deals with giving preference to those who propose to establish both cardiac catheterization and open heart surgical services. Since there is no established need for an open heart surgery service in the District, St. Joseph could not and does not plan to provide for one. Consequently, this preference is not pertinent here. The second preference is for those applicants who propose to establish a cardiac catheterization program in a county without any existing program. Again, this is not pertinent to the current situation. The third preference is toward applicants with a history of providing a disproportionate share of Medicaid and charity care. Here, St. Joseph is not a disproportionate Medicaid share provider, a point made by Fawcett. By the same token, however, neither is Fawcett. Fawcett did not, over the years, keep an accurate record of the number of patients to whom it provided free medical services, or of the value of those services. It claims it did not realize the importance of those numbers, concerning itself more with the provision of the service rather than with the recording of it. It was not, for most of its existence, however, a Medicaid provider, applying for and gaining that certification as of September l, 1989. Yet, during those non-certified, unrecorded years, it claims to have provided care to patients regardless of their ability to pay. While this claim is accepted as true, it is impossible to quantify it. The fourth preference is given to applicants who agree to provide services to all patients regardless of ability to pay. St. Joseph has agreed to do so and has a history of providing care to the medically indigent. So does Fawcett, but Fawcett is not an applicant, so the preference issue does not, necessarily, apply. It is clear, however, that neither the existing providers nor the applicant are precluded or disqualified as a result of the application of these preferences. Turning to the local, (District) Health Plan, which is also to be considered in the evaluation of the projects, the 1989 update of the District VIII Plan, that pertinent here, also provides for applicants to be evaluated in light of several preferences. One calls for an applicant to provide certain services, all of which are provided currently by St. Joseph. The second preference calls for the laboratory to be open no less than 40 hours a week and to provide a maximum waiting time of one month for simple, elective cases. The evidence presented indicates that the currently operating facilities meet this criteria, but also that St. Joseph will likely do the same if approved. Another preference relates to the proposed program's impact on existing providers in the area. It is here that the parties disagree radically on whether or not such an impact exists. St. Joseph has taken the position that its program will have only minimal impact on the ability of Fawcett and other existing providers to continue to provide quality economic service. On the other hand, Fawcett projects a major negative impact on its services, and claims the Department apparently failed to consider, at the time it did its initial evaluation, whether or not St. Joseph's program would adversely impact on it's existing service. Fawcett contends that its presently improving financial posture will be definitely impacted adversely by St. Joseph's implementation of the new service, if approved, in that its anticipated positive financial improvement will be reduced, if not destroyed, by the opening of St. Joseph's proposed program. Evidence produced by Fawcett tends to indicate that by 1994, if current projections hold true, Charlotte County will experience an increase of only 180 diagnostic catheterizations per year. St. Joseph's projections indicate that in that timeframe it expects to perform 509 diagnostic catheterizations per year. Simple arithmetic, then, would reveal that if those figures are correct, 329 of the 509 projected diagnostic procedures would have to come from the number of procedures performed by both Fawcett and Medical Center. Since approximately 75% of the current cardiac catheterizations performed in Charlotte County are performed at Fawcett, by far the greatest impact would be on that institution. The figures projected indicate a loss by Fawcett, then, of 232 procedures in 1993 and 318 in 1994. Medical Center's projected losses would be somewhat less, but nonetheless, such a reduction, if realized, would result in a loss of revenue to each of the existing providers from current income levels. Fawcett experienced severe financial problems during the past several years prior to the incumbency of the present CEO. In 1987 and 1988, it had financial losses which were improved in 1989 to a result showing a marginal excess of revenue over expenses. For 1990, Fawcett expects to show a profit for the first time in several years. Its prior negative operating result, however, has had a negative impact on its debt to equity ratio which, itself, is significant in that it is used by lenders as an index or flag regarding the financial health of an institution which seeks to borrow money. Because of its poor financial condition in the past, Fawcett was unable recently to borrow money needed for 1990 capital projects, and it is the increasing profit margin, which Fawcett hopes will make it more competitive in the borrowing market, that is most threatened by the proposed initiation of St. Joseph's project. The improved financial picture which Fawcett experienced in the most recent financial years has been directly attributed to the revenue earned by its cardiac catheterization program. In 1989, Fawcett determined that each cardiac catheterization patient contributed $1,927.00 to the hospital's financial health, and Fawcett contends that each patient taken from it by the opening of St. Joseph's proposed program will result in a financial loss to it. Utilizing the 1989 contribution margin projected to 1993 and 1994 reflects that if St. Joseph's program is approved, and if the anticipated numerical patient load is lost, the net financial loss to Fawcett would be in excess of $446,000.00 in 1993 and in excess of $612,000.00 in 1994. If these figures are inflated to 1993 and 1994 dollars, the loss could well be greater. Fawcett contends that it is currently experiencing a healthy improvement in its financial position which it anticipates would be substantially and adversely affected by the loss of cardiac catheterization patients to St. Joseph if that facility's project were approved as proposed. No doubt there would be a negative impact, but the degree thereof is speculative. Both the statute and the rule mentioned previously set forth criteria for the evaluation of these projects. One is the existence of an alternative to the service provided. Whereas St. Joseph contends there is no alternative diagnostic procedure preferable to cardiac catheterization, Fawcett contends there are several alternatives to St. Joseph's proposed project. Nonetheless, prior to its application, St. Joseph considered some alternatives. One was the setting up of a mobile laboratory on an interim basis. Since this could be used only by outpatients, it was determined not to meet the need of those patients requiring an inpatient procedure or of the physicians who would perform in it, and the anticipated $1.3 million cost was considered excessive for a short term fix. It is so found. Another was the possibility of establishing the lab somewhere within the hospital's existing space, but a survey of the facility quickly revealed there is no available existing space. However, since a part of the service proposed by St. Joseph would include outpatient catheterization, this part of the need could be met by the laboratory established in Charlotte County by several cardiologists who practice on the staff of St. Joseph, and who recently established a facility in the county. By the same token, if a need for outpatient procedures is demonstrated, the existing inpatient program could, Fawcett contends, provide it. Finally, is the existence of under-utilized programs at Fawcett and the Medical Center which have existing excess capability which could be considered an adequate and available alternate to the St. Joseph program. Turning to the question of financial feasibility, another evaluation criteria, there is no doubt that St. Joseph has the ability to borrow the capital to make the project financially feasible in the immediate future. St. Joseph's financial condition is sound. As might be expected, there is substantial difference in opinion as to the reasonableness of the pro forma projections submitted by St. Joseph's as evaluated by the Department. In fact, the parties agree to very little. St. Joseph contends that the patient mix estimated in the application is reasonable and based on its experience and that of Lee Memorial Hospital, and that the staffing level is appropriate and reasonable, and there is little to contest. The major difference in positions is in the area of supply costs and the percentage of patients accounted for by Medicare. St. Joseph estimated a supply cost of $248.00 per admission in 1989 dollars, inflated by 7% per year up to 1993 and 1994, but Fawcett contends the actual supply cost in 1989 dollars is $492.00 per admission. Assuming, arguendo, that Fawcett is correct, the projected supply costs would then be increased by in excess of $85,000.00 in 1993 and almost $126,000.00 in 1994, and this would result in a reduction of projected income for the service in both years. Fawcett's evidence and argument here are not persuasive, however. Fawcett also contends that St. Joseph's assumption that 58.9% of the cardiac catheterization patients would be Medicare, a figure which assumes that the Medicare patient utilization for catheterization would be the same as the facility as a whole, is not reasonable. Fawcett relies on the fact that St. Joseph is the sole obstetrics provider in Charlotte County and the majority of these obstetric patients are not Medicare patients. Considering that along with the fact that cardiac catheterization is a service which has a higher level of Medicaid utilization than St. Joseph presently provides, a more likely and reasonable predictor of the Medicare utilization of St. Joseph's program would be the Medicare utilization for the two existing catheterization programs. Fawcett's utilization in that regard is 64.6% and Medical Center's is 70.5%. Extrapolating from those figures, Fawcett contends a reasonable financial projection for St. Joseph's program would be 65% Medicare utilization. Since that type of service is reimbursed on the basis of DRG, the amount of income to the hospital is less, and the resultant contractual allowances, deductions from revenue, would be in excess of $61,000.00 in 1993 and more than $87,000.00 in 1994. Therefore, combining both the increase in projected supply costs and the decrease in projected income from Medicare, Fawcett contends that the projected number of catheterizations in 1994 and 1994, as modified using Fawcett's figures would result in a net reduction of approximately $210,000.00 in the former year and in excess of $126,000.00 in the latter. If those figures prove correct, St. Joseph's proposed program , it is suggested, would apparently not be feasible in the long term. On the other hand, St. Joseph contends its utilization figures for 1993 and 1994 are reasonable in that it projects a volume slightly greater than one-half of the number of procedures accomplished by Fawcett in its first year of operation. St. Joseph's expert evaluated the use projections for the first two complete years of operation and the costs assumptions and found both to be reasonable. Nonetheless, he also accomplished calculations of profitability utilizing Fawcett's suggested increased costs figures, and utilizing three different approaches, ultimately concluded that even looking at the worst case scenario, St. Joseph's proposal would be financially feasible both in the short and the long term. Independent analysis of the evidence leads to the conclusion that the projected staffing level and the salaries and benefits for that staff are reasonable. The anticipated reimbursements on the basis of the DRG's are reasonable. The projected utilization in the first and second years of operation are reasonable, and taken together, the evidence supports the conclusions drawn by St. Joseph's expert. It is so found. Another area for consideration is the impact St. Joseph's program would have on Fawcett's existing program. Fawcett's program has now been in operation for several years and even with approval of St. Joseph's, will continue to operate without competition until the second half of 1992, after which St. Joseph's program would be in a start-up configuration for at least a year. As such, it will be well into 1993 and possibly into 1994 before St. Joseph's program can be considered to have its full impact vis-a-vis the Fawcett program. Fawcett's expert, who concluded that St. Joseph's program would have a serious adverse effect on Fawcett's ability to contribute to its improving financial picture did not consider the fact that Fawcett does not currently perform outpatient cardiac catheterization procedures, and any of that nature done by St. Joseph should have no impact on Fawcett. The expert also did not consider in his analysis of impact any population growth beyond 1990 or growth in the demand for diagnostic catheterization procedures. Fawcett listed approximately $13.7 million in proposed capital expenses over the next five years which, it claims, will be adversely impacted by the effect of St. Joseph's proposed program on its cash picture. Many of the line items within this figure are much the same as normal routine replacement items, and only $3.5 million represent the cost of items specifically identified as needed to meet existing life safety code violations or for accreditation purposes. No doubt there will be some impact on Fawcett's operation by the opening of St. Joseph's program, yet Fawcett has not demonstrated clearly that the impact will result in a return to the pre-1990 negative cash position which was shown to now be reversing. Even accepting Fawcett's expert's assumptions, the likelihood is great that Fawcett's equity balance would increase by over $900,000.00 from 1992 to 1993 and by over $800,000.00 from 1993 to 1994. So long as Fawcett's cardiac catheterization program performs more than 182 procedures per year, its current break-even point, no negative impact to the hospital's overall financial picture is likely to occur. Assuming that Fawcett's procedures were no more than one-half its 1990 admissions, at current rates, its program would render a positive contribution of more than $650,000.00 to the hospital's financial picture. This figure could not be considered as other than a viable financial contribution. What is more, the implementation of the program at St. Joseph should not exert any upward pressure on the cost of other services rendered by St. Joseph, and should, by competition, moderate future price increases for this procedure at the two competing facilities. As regards Medicaid and indigent care, St. Joseph has been a Medicaid provider since 1965 and has a history of providing service to indigent patients and under-served groups. In fact, the value of care rendered without cost to patients by St. Joseph has climbed from $418,000.00 in 1988 to a projected $1.5 million in 1991. By the same token, its commitment to Medicaid has increased to almost 4% in 1990, in addition to approximately 2% of uncompensated care that same year. The obstetric unit has been shown to operate $500,000.00 a year in the red because of the volume of indigent care provided. Nonetheless, St. Joseph agrees to accept a condition to its CON requiring it to provide 1.5% Medicaid and 2% charity care. In comparison, Fawcett was not certified for Medicaid until late 1989 and its experience since that time has not been substantiated. This tends to underscore the Department's contention that Medicaid and charity patients are under-served within the Charlotte County area. Other criteria outlined within the statute have not been shown by evidence presented, as being significantly affected one way or the other by the implementation of St. Joseph's proposed program. Several of the statutory criteria are, in fact, not applicable to the proposed project in this case. Much the same can be said for the criteria outlined in Rule 10-5.011(1), F.A.C., which tend to overlap to a substantial degree with the statutory review criteria. Fawcett claims that the application filed with the Department by St. Joseph is "very incomplete" in that it omits significant information regarding project costs, capital expenses, source of funds, and a litany of other required information. It claims, therefore, that the Department could not have conducted any meaningful review of the application based upon the information provided. The Department's representative, Ms. Dudek, admits that most, if not all applications omit some information. That is the purpose of the omissions letter which is sent to an applicant after initial review. Not all information called for by the statute is deemed essential however. If an omission is considered immaterial, it will not cause the application to be denied, all other essential material being provided. There are primarily two criteria called for by the statute which are essential to Departmental approval. The first deals with the applicant's access to resources to develop and operate the project, and the second is that the applicant offer quality care. In this case, both were deemed to have been met as was stipulated to by Fawcett. In the instant case, the Department's representative concluded that St. Joseph's application was one of the most thorough and comprehensive, in terms of presentation and backup, to have been filed within the past few years.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered by the Department approving St. Joseph's application for an inpatient cardiac catheterization laboratory, (CON #6202) for District VIII. RECOMMENDED in Tallahassee, Florida this 4th day of April, 1991. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of April, 1991. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-5815 The following constitutes my specific rulings pursuant to Sec 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. & 4. Accepted. 5. & 6. Accepted. 7. - 10. Accepted and incorporated herein. 11. & 12. Accepted. 13. & 14. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted and incorporated herein. 22. - 26. Accepted and incorporated herein. 27. - 34. Accepted. Rejected. - 39. Accepted. 40. - 42. Accepted and incorporated herein, except for the first sentence of Finding 41. Rejected. Accepted and incorporated herein. & 46. Accepted. Rejected. Rejected. - 51. Accepted and incorporated herein. Accepted. Accepted. Not proven. - 59. Accepted and incorporated herein. Accepted that the loss of revenue will have an impact but the loss has not been shown to be substantial. - 65. Accepted and incorporated herein. 66. & 67. Accepted. 68. - 76. Accepted incorporated herein in substance. Rejected that the loss of revenue would "cripple" the health trend. It would adversely affect it but not cripple it. - 83. Accepted and incorporated herein. 84. - 90. Accepted. Accepted. Accepted and incorporated herein. - 97. Accepted that there are alternatives, but rejected that they are acceptable or adequate. Rejected as too broad a statement. Rejected as to the conclusion of waste. & 101. Accepted. Ultimate conclusion rejected. Need for level of education and experience accepted. Accepted. Underlying fact accepted. Balance is editorialization. - 108. Accepted. Accepted. Not an appropriate Finding of Fact. Accepted. & 113. Accepted and incorporated herein. 114. - 116. Rejected. Accepted. & 119. Rejected. 120. & 121. Accepted and incorporated herein. Rejected. - 126. Accepted. 127. & 128. Accepted. 129. & 130. Rejected. 131. & 132. Accepted. 133. & 134. Rejected. Not a Finding of Fact but a comment of the state of the evidence. Accepted. & 138. Accepted. Accepted. Rejected. & 142. Accepted. Rejected. St. Joseph was a Hill-Burton hospital. Accepted. Accepted that St. Joseph receives funds from taxes and other sources, but the conclusions that aid to Medicaid an the indigent "is to be expected" is an unjustified conclusion. 146. Accepted. 147. Accepted but probative value questionable. 148. Accepted that it is less costly. 149. First two sentences accepted. Remainder not proven. 150. Rejected. 151. & 152. Accepted in the short term. 153. Accepted. 154. Not proven. 155. Rejected. 156. - 158. Rejected. 159. & 160. Accepted. FOR THE RESPONDENT AND INTERVENOR: 1. - 3. Accepted and incorporated herein. Accepted. - 8. Accepted and incorporated herein. Accepted. - 13. Accepted. 14. - 16. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted. 22. - 24. Accepted and incorporated herein. Accepted and incorporated herein. - 28. Accepted and incorporated herein. Accepted and Incorporated herein. - 35. Accepted and incorporated herein. 36. - 41. Accepted and incorporated herein. Accepted. - 45. Accepted and incorporated herein. 46. & 47. Accepted. 48. & 49. Accepted and incorporated herein. 50. & 51. Accepted. 52. - 54. Accepted and incorporated herein. 55. - 58. Accepted. 59. & 60. Accepted and incorporated herein. Accepted. Accepted. & 64. Not Findings of Fact but a comment on the state of the evidence. 65. & 66. Accepted and incorporated herein. Not a Finding of Fact but a statement of party position. Not a Finding of Fact but a comment on the evidence. & 70. Accepted and incorporated herein. 71. & 72. Accepted and incorporated herein. Accepted. Accepted. Not a Finding of Fact but a comment on the evidence. Accepted. - 80. Accepted and incorporated herein. Accepted but irrelevant to the issues here. Accepted but considered more a statement of party position and a comment on the evidence. & 84. Accepted and incorporated herein. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted and noted in the Conclusions of Law portion of the Recommended Order. - 100. More proper as Conclusions of Law than as Findings of Fact, but accepted where pertinent. COPIES FURNISHED: John D. C. Newton, II, Esquire Aurell, Radey, Hinkle & Thomas Suite 1000, Monroe-Park Tower P.O. Drawer 11307 Tallahassee, Florida 32302 Richard Patterson, Esquire DHRS 2727 Mahan Drive Tallahassee, Florida 32308 R. Terry Rigsby, Esquire Philip Blank, P.A. P.O. Box 11068 Tallahassee, Florida 32302 Linda K. Harris Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700
Findings Of Fact At all times material hereto, Respondent has been licensed to practice medicine in the State of Florida, having been issued license number ME-0027913, and was employed by the Norton Seminole Medical Group in Pinellas County, Florida. Respondent has been licensed in Florida since 1976. At approximately 3:50 p.m. on November 1, 1983, a 31 year old white male, with the initials R. L., arrived at the emergency room of Lake Seminole Hospital, Seminole, Florida, and was examined by the emergency room physician on duty. R. L. complained of substernal mid-chest pain radiating to his back, which had begun the night before. He was agitated and exhibited a great deal of emotional stress. The emergency room physician on duty treated R. L. for suspected cardiac pathology, placed him on a cardiac monitor, inserted a heparin lock into a vein, and ordered lab work which included a chest x-ray, electrocardiogram, electrolytes, cardiac enzymes, CBC (complete blood count), blood sugar, creatinine and BUN (blood urea nitrogen). These were appropriate tests under the circumstances. When the Respondent came on duty in the emergency room at 7:00 p.m., all lab work had been completed, except for the cardiac enzymes. The emergency room physician who had been on duty when R. L. appeared at the emergency room briefed Respondent about R. L.'s medical history, condition while in the emergency room, and the test results which had been received. After the cardiac enzyme values were received, Respondent reviewed R. L.'s medical history and lab test results, which he determined to be normal, and discharged R. L. at approximately 7:35 p.m. on November 1, 1983, with instructions that he see his family physician the next morning. Respondent's discharge diagnosis for R. L. was atypical chest pain secondary to anxiety. At approximately 11:21 p.m. on November 1, 1983, R. L. expired from cardiopulmonary arrest at the emergency room of Metropolitan Hospital, Pinellas Park, Florida. The autopsy report notes extensive coronary artery disease, but makes no mention of acute myocardial infarction. It was not established by clear and convincing evidence that R. L. suffered an acute myocardial infarction. There is conflicting expert testimony from Steven R Newman, M.D., and Stephen J. Dresnick, M.D., concerning whether Respondent should have admitted R. L. to Lake Seminole Hospital instead of discharging him from the emergency room, and also whether his E.K.G. taken at the emergency room was normal. Drs. Newman and Dresnick are experts in the care and treatment of patients in an emergency room, but their testimony was received by deposition instead of through live testimony at hearing. Thus, based upon this conflict in testimony, and the fact that the demeanor of these witnesses cannot be assessed, it is found that it was not established by clear and convincing evidence that Respondent failed to practice medicine with that level of care and skill which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances when he discharged R. L., and evaluated the tests which were administered to the patient while in the emergency room as within normal limits. A patient who appears at a hospital emergency room with unstable angina, such as R. L., does not necessarily require admission to the hospital. While serial electrocardiograms and serial cardiac enzymes are called for with patients whose symptoms of cardiac discomfort warrant hospitalization, these procedures are not usually and customarily performed in an emergency room. Therefore, since it was not established that Respondent should have admitted R. L. to the hospital as an in-patient, it was also not established that he failed to exercise the required level of skill and care by failing to order such serial tests while R. L. was in the emergency room. Although the emergency room physician on duty when R. L. arrived at the emergency room at approximately 3:50 p.m. on November 1, 1983, was initially responsible for obtaining a patient history and ordering the tests which were performed, when Respondent came on duty at 7:00 p.m. and took over this case, he was also responsible for insuring that his medical records concerning his evaluation and treatment of R. L., as well as his decision to discharge the patient, were full and complete. Respondent failed to document his review and findings based upon the lab tests and chest x-ray which had been completed, as well as the patient's medical history, and the specific reason or basis for his decision to discharge R. L. Respondent relied almost completely on the medical records compiled by the emergency room physician who was initially on duty when R. L. arrived at the emergency room, and made no significant additions to those records while the patient was under his care, or which would justify his course of treatment, including discharge, of this patient.
Recommendation Based upon the foregoing, it is recommended that the Board of Medicine enter a Final Order reprimanding Respondent for his violation of Section 458.331(1)(m), Florida Statutes, and placing him on probation for a period of six months from the entry of the Final Order in this case, conditioned upon his complying with such reasonable terms and conditions as the Board may impose, including review and verification of the completeness of medical records prepared by the Respondent while on probation. DONE AND ENTERED this 5th day of July, 1990 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 5th day of July, 1990. APPENDIX (DOAH CASE NO. 89-6874) Rulings on the Department's Proposed Findings of Fact: 1-2. Adopted in Finding of Fact 1. 3-4. Adopted in Finding of Fact 2. 5-6. Adopted in Finding of Fact 3. 7. Adopted in Finding of Fact 4. 8-9. Rejected in Finding of Fact 5. 10. Rejected in Finding of Fact 4. 11-12 Rejected in Finding of Fact 6. 13. Adopted in part in Finding of Fact Rejected in Findings 5 and 6. 7, but otherwise Rulings on the Respondent's Proposed Findings of Fact: Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2 and 3. 4-5. Adopted in Finding of Fact 2. 6. Adopted in Finding of Fact 3. 7-9. Adopted in Finding of Fact 4. Rejected in Finding of Fact 5. Rejected in Finding of Fact 7. 12-13. Adopted in Finding of Fact 6. Adopted in part in Finding of Fact 2, but otherwise Rejected in Finding of Fact 5. Adopted in Finding of Fact 5. Rejected in Finding of Fact 7. COPIES FURNISHED: Andrea Bateman, Esquire Kevin F. Dugan, Esquire 1940 North Monroe Street Wittner Centre West Suite 60 Suite 103 Tallahassee, FL 32399-0792 5999 Central Avenue St. Petersburg, FL 33710 Kenneth E. Easley, Esquire General Counsel 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issue for determination in this case is whether Respondent violated certain provisions of Chapter 458, Florida Statutes, as alleged in the Administrative Complaint, and if so, whether Respondent’s license to practice medicine in the State of Florida should be revoked or otherwise disciplined.
Findings Of Fact Petitioner, AGENCY FOR HEALTH CARE ADMINISTRATION, BOARD OF MEDICINE, is the agency of the State of Florida vested with the statutory authority to administer the provisions of Chapter 458, Florida Statutes, governing the practice of medicine. Respondent, RAMESCHANDRA BHAGWANDAS SHAH, M.D., is now, and at all material times hereto was, licensed to practice medicine in the State of Florida holding license number ME 0050099. Respondent was first licensed to practice medicine in the State of Florida in 1987. At all material times hereto, Respondent was employed as an emergency room physician at Polk General Hospital in Bartow, Florida. Prior to being employed at Polk General Hospital, Respondent was employed with E.P.I., an Emergency Physician’s Group. Dr. Jay Edelberg, who testified in this proceeding as an expert witness for Petitioner, is the President and CEO of E.P.I. Respondent’s primary duties with E.P.I. related to emergency treatment for prisoners at various institutions under contract with E.P.I. Respondent became employed at Polk General Hospital in November of 1993. Polk General Hospital treats a majority of indigent patients. Polk General does not employ a cardiologist, nor does the hospital have a cardiac laboratory. Nurse Elsie Samuels has been a registered nurse for eighteen years, and has worked for more than nine years in emergency rooms. Nurse Samuels is certified in advanced cardiac life support. Dr. Jay Edelberg and Dr. Henry Smoak, III, were qualified in this proceeding as expert witnesses in the field of emergency room medical practice and are both highly qualified by experience and education. Hospitalization of November 29-December 1, 1994 The allegations of the Administrative Complaint relate to the care and treatment of Patient L.G.T., a 59-year old male. Patient L.G.T. first presented to the emergency room of Polk General Hospital at approximately 9:00 a.m. on November 29, 1994 complaining of chest pain, a very common complaint in emergency room medical practice. Like many of the patients at Polk General Hospital, Patient L.G.T. was indigent and without medical insurance. At this time, Patient L.G.T. was initially evaluated by Dr. C. B. Clark, the emergency room physician on call at the time. Patient L.G.T. reported an episode of chest pain that had recently occurred at approximately 3:00 a.m. that morning. Upon presentation Patient L.G.T. did not exhibit or report shortness of breath, other respiratory distress, nausea, or a family history of cardiac problems. Patient L.G.T. reported that his primary symptom was a feeling of “gas” moving around. Patient L.G.T.’s cardiac risk factors included his age, gender, and a history of hypertension. After the initial emergency room examination, Patient L.G.T. was referred by Dr. Clark to Dr. Thieu Nguyen, an internist at Polk General Hospital for further evaluation. As set forth above, there was no cardiologist on staff at Polk General Hospital. Patient L.G.T. was admitted to Polk General Hospital on November 29, 1994, and discharged by Dr. Nguyen on December 1, 1994. During this three-day hospitalization, Patient L.G.T. underwent a thorough cardiac evaluation, including three electrocardiograms (EKGs), an echocardiogram, cardiac enzymes test, and a complete blood work-up. The results of the cardiac work-up as evaluated by Dr. Ngyuen were inconclusive. The EKGs were abnormal, but non- diagnostic. In this respect, the EKGs indicated questionable anterolateral ischemia; however, Patient L.G.T. was not experiencing chest pain during the hospitalization. The EKG results showed some depressions in the ST changes at V5-V6. This result, however, was not diagnostic of myocardial infarction because if Patient L.G.T. was experiencing a myocardial infarction a rise in ST elevation would be expected. The results of the AST and LDH blood studies indicated a normal range. The results of the cardiac enzyme test revealed some levels were elevated. Dr. Nguyen, however, concluded that the cardiac enzyme elevation was due to non-cardiac causes. This conclusion appears contradictory in these circumstances, and there is no indication in the record upon what basis Dr. Nguyen arrived at this conclusion. Dr. Nguyen also noted that the patient’s chest pain was not typical, and might be due to gastrointestinal problems. Patient L.G.T. had a history of hypertension, and a cholesterol reading of 302, which was high. The normal range is 100 to 200. On December 1, 1994, Patient L.G.T. was discharged from Polk General Hospital by Dr. Nguyen, with follow-up treatment ordered in three days including EKGs, blood work-up, and further cardiac enzymes. At the time of Patient L.G.T.’s discharge, Dr. Nguyen made no specific diagnosis of cardiac disease. Emergency Room Admission of December 2, 1994 Patient L.G.T. returned to the emergency room of Polk General Hospital at 12:55 a.m. on December 2, 1994, approximately twelve hours after his discharge by Dr. Nguyen. Respondent was the physician on duty at this time. Nurse Samuels was also on duty in the emergency room. An initial intake evaluation was performed by the triage nurse which indicated that Patient L.G.T. reported he began experiencing chest pain at approximately 2:00 p.m. on December 1, 1994, with the pain primarily located in his chest and under his left arm. Patient L.G.T. did not at this time appear in acute distress, and denied any radiating pain. Patient L.G.T.’s vital signs were normal. Patient L.G.T. was then referred to Respondent who performed a physical examination which specifically evaluated the patient for signs typical of myocardial ischemia including: constricting chest pain, perspiration, respiratory disorders, vomiting or nausea, paleness, elevated temperature, and elevated pulse rate. Respondent’s physical examination of Patient L.G.T. showed no findings indicative of myocardial ischemia. Nurse Samuels was present during the physical examination by Respondent. At this time Patient L.G.T. expressed generalized complaints of discomfort, and did not indicate specific complaints which were cardiac in origin. Upon completion of the physical examination, Respondent ordered a cardiac enzyme test for Patient L.G.T. The results of the cardiac enzyme test indicated that at 1:25 a.m. on December 2, 1994, that the CPK, ASTs, and LDs were in the normal range. Respondent also ordered an EKG for Patient L.G.T. The computerized results of the EKG as of 1:23 a.m. on December 2, 1994 indicated that there were non-specific ST and T-wave abnormalities. These computerized results were identical to the results of the EKG performed on L.G.T. on December 1, 1994 at 7:19 a.m. during his previous hospitalization and evaluation by Dr. Nguyen. Both expert witnesses, Dr. Edelberg and Dr. Smoak, agreed that these computerized EKG results were common for a man of L.G.T.’s age. Both experts also agreed that there was no acute change between the EKG results of December 1, 1994 and December 2, 1994. Chest pain alone is not diagnostic of myocardial infarction, and may be the result of several causes including gastrointestinal problems, as indicated in this case by Dr. Nguyen during L.G.T.’s previous hospitalization. At 1:05 a.m. and 1:15 a.m. on December 2, 1994, Patient L.G.T. was given nitroglycerin for relief from angina, and gastroesophageal pain. At 2:15 a.m. Patient L.G.T. reported that he was not experiencing chest pain which was reported to Respondent by the emergency room nurse. At 2:45 a.m. Respondent, after evaluating the results of Patient L.G.T..’s physical examination, EKG, cardiac enzymes, and blood work-up, decided to discharge Patient L.G.T. from the emergency room. At this time Patient L.G.T.’s vital signs were normal, and he was not experiencing any chest pain. After being informed that he would be discharged, Patient L.G.T. informed Nurse Samuels that he was experiencing chest and back pain, and that he also was experiencing nausea. Nurse Samuels informed Respondent of the patient’s reported condition. Patient L.G.T. also told Nurse Samuels that he had eaten spicy fish earlier that day while at home. Respondent then prescribed for Patient L.G.T. a “G.I. cocktail,” consisting of a combination of medications given to relieve gastrointestinal discomfort, which was administered at 2:50 a.m. on December 2, 1994. At 3:10 a.m. Patient L.G.T. stated, “I can’t go home, I am sick.” Patient L.G.T. requested that Respondent admit him to Polk General Hospital. Respondent reviewed with Patient L.G.T. the results of his EKG, cardiac enzyme tests and physical examination, and informed him that there was no basis for admission. Patient L.G.T. kept telling Respondent to send him upstairs and admit him. At this time, Respondent did not consult with Dr. Nguyen or any other internist on staff at Polk General Hospital regarding Patient L.G.T. on December 2, 1994. Respondent had reviewed Dr. Nguyen’s records regarding Patient L.G.T. and was aware of the apparent contradictory conclusion that elevated cardiac enzymes were due to non-cardiac causes, but did not question this conclusion. At 3:15 a.m. on December 2, 1994, Patient L.G.T. was discharged by Respondent from the emergency room at Polk General Hospital. At this time Patient L.G.T. appeared to be in stable condition, and stated to Nurse Samuels that he would call his family to take him home. Post Discharge Incident At approximately 4:20 a.m. Nurse Samuels had gone to her car and was returning to the emergency room when she was informed that someone had collapsed in the emergency room lobby. Nurse Samuels went to investigate and found Patient L.G.T. unresponsive, with face down in vomit, with no pulse, no respiration, and urine incontinent. Both pupils were fixed and dilated. A code was instituted, and Patient L.G.T. was taken back to the emergency room. All efforts to resuscitate him were unsuccessful. Patient L.G.T. was pronounced dead at approximately 5:00 a.m. on December 2, 1994. The stated diagnosis was probable aspiration/asphyxia. Respondent requested that the medical examiner perform an autopsy on Patient L.G.T.. It is stipulated by the parties that an autopsy should have been performed on Patient L.G.T., but was not performed and that there was only a visual examination of Patient L.G.T. by the medical examiner before rendering cause of death.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the application of Central Florida Surgical Ambulatory Center be DENIED. DONE and ORDERED this 27th day of March, 1985, in Tallahassee, Florida. DONALD R. ALEXANDER 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 27th day of March, 1985.
The Issue The issue for determination is whether Petitioner should be awarded a certificate of need authorizing the establishment of cardiac catheterization laboratory services at its facility in Port Charlotte, Florida. As a result of stipulations of the parties presented at hearing, matters for consideration were limited to whether Petitioner meets the criteria of availability of funds for capital expenditures for the project in accordance with Section 381.705(1)(h), Florida Statutes; and whether Petitioner has shown the existence of need for additional services by any existing medically underserved groups in the service area.
Findings Of Fact The parties have stipulated that Petitioner does not meet the criteria of Section 381.705(1)(a), Florida Statutes, because there is no numeric need for the program established by any agency rule formula and that no emergency or other not normal circumstances exist, including problems of geographic, financial or programmatic access, justifying the program in the absence of such enumerated need. Petitioner's agreement to this stipulation was conditioned upon an assumption that previous Certificates of Need, formerly granted by final orders of Respondent to other entities in previous batching cycles and now the subject of legal appeals by Petitioner in the appellate court, will eventually be confirmed by that court to have been properly issued. The parties have stipulated that Petitioner, as the result of nonexistence of numeric or nonnumeric need, has not met criteria regarding its ability to provide quality care, a requirement of subparagraph (c) of Section 381.705(1), Florida Statutes; has not met criteria regarding availability and adequacy of other health care facilities in the applicant's service district, a review component set forth in Section 381.705(1)(d), Florida Statutes; has not met criteria regarding immediate and long term financial feasibility of Petitioner's proposal, a requirement of Section 381.705(1)(i), Florida Statutes; has not met criteria regarding the impact of the proposed project on the costs of providing such health services, a requirement of Section 381.705(1)(l), Florida Statutes; and has not met criteria, as required by Section 381.705(2)(a)-(d), Florida Statutes, regarding alternative services, efficiency of existing services, alternatives to new construction or the likelihood of patients obtaining the proposed service in the absence of Petitioner's proposal. The parties have stipulated that review requirements of subparagraphs (e), (f), (g), (j), and (k) of Section 381.705(1), Florida Statutes, are found not to be applicable to this proceeding. Those subparagraphs relate, respectively, to economics of shared services, need for special services, need for research and educational facilities, special needs of health maintenance organizations and needs of entities serving residents outside the service area. The parties have stipulated that the criteria ofSection 381.705(1)(b), Florida Statutes, has not been met because they were not addressed or challenged by Petitioner. However, Petitioner does contest the accessibility by medically underserved groups of existing and approved providers in the service district. With the exception of the availability of funds for capital and operating expenditures related to the project in Petitioner's application and the extent to which the proposed services will be accessible to all residents of the service district, further stipulation between the parties also establishes that the review criteria contained in Section 381.705(1)(h), Florida Statutes, does not apply to this proceeding. Portions of Rule 10-5.011(b), Florida Administrative Code, relating to accessibility of services to residents of the service district are also excepted from consideration in this proceeding by the parties' stipulation. By stipulation of the parties, it is established that the review requirement of Section 381.705(1)(l), Florida Statutes, relating to the probable impact of the proposed project on the cost of providing services proposed by Petitioner, is met. The parties' stipulation further establishes that requirements of Section 381.705(1)(m) and Section 381.705(1)(n), Florida Statutes, have been met. These statutory subparagraphs relate, respectively, to methods and costs of proposed construction, and Petitioner's past and proposed provision of health care services to medicaid and medically indigent patients. Petitioner is a separate, albeit subsidiary,corporation from its parent, Bon Secours Health Systems, Inc., (Bon Secours) a "not for profit" corporation based in Marriottsville, Maryland. Approximately 80 percent of the total project cost of $1,450,000 cost is expected to come from the parent organization and not Petitioner's corporation. The project has been approved by Petitioner's corporation and management approval has been granted by Bon Secours, subject only to final board approval and reevaluation by the parent corporation on an annual basis until the actual capital expenditure is incurred. Petitioner's parent corporation uses either a line of credit or goes to the tax exempt bond market to meet capital expenditure needs. The bond market is utilized when capital needs exceed $15 million for the year. Whether the funding source for Petitioner's project would come from a line of credit or bond financing would not be known until the actual year in which the expenditure is incurred. Bon Secours includes Petitioner in its obligated group which consists of a system-wide master trust indenture established in 1985. The group consists of eight hospitals and three long term care facilities. Weaker entities in the group have the benefit of the credit strength of the group's entire system. In this regard, Bon Secours enjoys a Standard & Poors and Moodys' bond rating of A+ and A-1, respectively. The corporation is a good credit risk with a strong financial position and good earnings record. Over the next five years, Bon Secours has the ability to raise in excess of $100,000,000 in the bond market for funding purposes, inclusive of the project which is the subject of theseproceedings. Although final approval of Petitioner's project by Bon Secours' board of directors is expected shortly, that approval had not occurred at the time of final hearing. As a result, the proof fails to establish that Bon Secours is committed to provide financing for Petitioner's project. Petitioner presented expert testimony regarding accessibility by medically underserved groups to Petitioner's and other cardiac catheterization programs. Petitioner's expert placed the size of the medically indigent population, a subcategory of the medically underserved group, at six to seven percent of the total population of the service area. Due to the lack of specificity of the methodology used in arriving at the cited percentage figure, no credibility can be ascribed to that population percentage. However, both Respondent and Petitioner concede the existence of this group in the district service area sought to be served by Petitioner's project. Petitioner has not established whether the medically indigent population is denied access to cardiac catheterization programs within the district service area. While Petitioner's hospital is a medicaid provider with a proactive policy of aiding the medically indigent, the availability of cardiac catheterization services exist for this group at Intervenor's medical center facilities, located only five miles from Petitioner's hospital. Intervenor is also a medicaid provider. The proof fails to establish that medicaid patients or medically indigentpatients are presently denied or turned away from Intervenor's facility. Further, the duplication of such services at Petitioner's hospital could effectively reduce the number of cardiac catheterization procedures required for the medical staff of Intervenor's laboratory to maintain proficiency. In point of fact, there is unused cardiac catheterization capacity at Intervenor's facility. As established by Intervenor's exhibit number one, there were 562 cardiac catheterization procedures performed at Intervenor's facility in 1988. The State Health Plan recites a minimum goal of 600 such procedures a year as a proficiency measurement; the Local Health Plan maintains that a minimum of 300 procedures should be performed to insure proficiency.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying Petitioner's application for approval of a cardiac catheterization Certificate of Need. DONE AND ENTERED this 29th day of June, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS 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 29th day of June, 1989. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-3. Adopted in substance, except that part (l) of proposed finding 3 was met by Petitioner. 4.-5. Addressed in part. To the extent that the last sentence of proposed finding 5 suggests the establishment of final approval by the parent corporation, it is rejected. 6. Accepted with the exception of approval by the parent corporation. The record supports a finding of approval by management of that corporation, but not the board of directors. 7.-8. Adopted in substance. Adopted in part, remainder rejected due to witness's inability to support her calculations as to percentages of the population within the service district classified as medically indigent. Addressed in part, remainder unnecessary to conclusion. Addressed in part, remainder rejected on basis of relevancy. Addressed. Rejected on basis of relevancy. Addressed in part, remainder rejected as argumentative and speculative. Respondent's Proposed Findings. 1.-2. Rejected. Treated in preliminary discussion. 3.-21. Adopted in substance. 22.-23. Adopted by reference. 24.-25. Addressed in substance. 26.-30. Adopted by reference. 31.-33. Adopted by reference. Intervenor's Proposed Findings. 1.-3. Adopted in substance. 4. Rejected as unnecessary. 5.-9. Adopted in substance. 10. Adopted by reference. 11.-12. Adopted in substance. COPIES FURNISHED: Joseph R. Buchanan, Esq. Suite 900, Sun Bank Building 777 Brickell Avenue Miami, FL 33131 Edgar Lee Elzie, Jr., Esq. 215 South Monroe Street, Suite 804 Tallahassee, FL 32301 E. G. Boone, Esq. 1001 Avenida del Circo Venice, FL 34284 Gregory L. Coler Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Sam Power Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Miller, Esq. General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
The Issue Whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact The Department is the State agency charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Dr. Mationg was a licensed physician in the State of Florida. His license, numbered ME 0028183, was issued on April 13, 1976. Dr. Mationg is the primary care physician of A.A. Dr. Mationg referred A.A. to Dr. Steven Schafer, an orthopedic surgeon, for pain in the right shoulder, which was found to require arthroscopic surgery and repair of a rotator cuff. On January 10, 2000, A.A. was admitted to Regional Medical Center Bayonet Point (Bayonet Point) for surgery. At the time of his admission to the hospital, A.A. was 65 years old and suffered from numerous medical problems. He had cardiomyopathy, meaning his heart was enlarged and not functioning properly. A.A. had high blood pressure and a history of heavy smoking. He had generalized arteriosclerosis and peripheral artery disease. A.A. had previously had surgeries involving the placement of a stint and angioplasty. Based on his medical history, A.A. was subject to a stroke and a heart attack. Prior to his admission to the hospital, A.A. had been taking aspirin daily. Approximately three days prior to surgery, A.A. was directed by Dr. Schafer to discontinue taking aspirin. The aspirin was discontinued to reduce the risk of A.A.'s blood not being able to clot sufficiently. The hospital records of A.A. contain a request for consultation with Dr. Mationg for medical management dated January 10, 2000. The discharge summary shows that the medical evaluation was obtained so that A.A. could be followed by his primary care physician for his hypertension and other medical history. Dr. Schafer performed the surgical procedure on A.A. on January 10, 2000. A.A. had some respiratory problems, and Dr. Mationg ordered a pulmonary consultation with Dr. Patel the afternoon of January 10, 2000. Because of the respiratory problems, A.A. was placed on a ventilator and transferred to the intensive care unit. On January 11, 2000, Dr. Patel extubated A.A., which means that A.A. was taken off the ventilator. On January 11, 2000, Dr. Mationg saw A.A. at 9:00 a.m. and wrote and signed an order for lasix and lanoxin for A.A. Around 3:15 a.m. on January 12, 2000, A.A. was awakened for respiratory therapy and experienced numbness in his left arm and slurring of speech. When A.A. smiled, the left side of his mouth remained flat while the right side turned up. The nurse on duty was called, and he observed A.A.'s symptoms. A.A.'s symptoms indicated that he was having a stroke. Nurse Culligan notified Drs. Schafer and Mationg. Dr. Mationg did not come to the hospital to evaluate A.A. The standard of care would have required him to come to the hospital to evaluate A.A. because A.A. was exhibiting the symptoms of a stroke. Instead of coming to the hospital to do an evaluation, Dr. Mationg gave the following orders telephonically to Nurse Culligan at 4 a.m., on January 12, 2000: T.O. Dr. Mationg/M. Culligan do CT head [without] contrast today a.m. do carotid doppler study today a.m. consult Dr. S. Shah for neuro eval. get speech therapy eval. and video swallow today. Nurse Culligan wrote the orders on A.A.'s chart; Dr. Mationg later countersigned the orders. The term "stat" in medical parlance means immediately or as soon as possible. An order is not presumed to be stat if the order does not specify that it is stat. The tests and consultation which Dr. Mationg ordered at 4 a.m., on January 12, 2000, were not ordered to be implemented stat. The standard of care for treating A.A. required that Dr. Mationg order a stat neurological consultation and a stat head CT scan. Bayonet Point has established policies for its imaging services department, including CT services. The normal hours for CT services are 7 a.m. to 11 p.m., Monday through Sunday. After normal hours, the services are provided on-call. Bayonet Point's call-back procedures include the following: When an emergent radiologic procedure is ordered after hours, the Radiology personnel will contact the appropriate on call technologist via the hospital operator. Once the procedure is complete, the Technologist will call the Radiologist on call and then transmit those images via Teleradiography. Definition of an emergent procedure: In- house STAT, Emergency Department physician requesting radiologist interpretation, any outpatient whose physician requests immediate radiologist interpretation or "wet reading." Prior to A.A.'s experiencing the symptoms of a stroke at 3:15 a.m., no orders had been given for A.A. to resume taking aspirin. At 10 p.m. on January 10, 2000, Dr. Schafer ordered that "till further notified" all medications taken by mouth which could be taken intravenously were to be administered via an IV. Aspirin could not be administered intravenously. Because Dr. Schafer had ordered that aspirin therapy be stopped prior to surgery, it would be the responsibility of Dr. Schafer to order the aspirin to be restarted. Dr. Schafer was at A.A.'s bedside at 8:30 a.m., on January 12, 2000. Dr. Schafer noted that a head CT scan was ordered for that morning and that the patient was on his way down for the test. Dr. Schafer also noted that a neurological evaluation had been ordered for A.A. for that morning. The hospital records show that at 8:50 a.m., on January 12, 2000, a call was made to Dr. Shah's answering service, requesting a neurological consultation. The request for consultation form, which was filled out after Dr. Schafer's visit at 8:30 a.m., indicated that the request was an emergency request. The request for consultation form was filled out by someone other than the nurse who charted Dr. Mationg's verbal order for a neurological consultation. Based on the evidence presented, the request for a neurological consultation was not treated as an emergency request until after Dr. Schafer saw A.A. at 8:30 a.m. Tissue Plaminogen Activators (TPA) are used to dissolve clots which may be causing a stroke. The use of TPA is limited to a three-hour window following the onset of stroke symptoms. Dr. Mationg did consider the use of TPA, but felt that it was contraindicated based on the recent surgery. This opinion was confirmed at final hearing by a neurologist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Dr. Mationg violated Subsection 458.331(1)(t), Florida Statutes; finding that Dr. Mationg did not violate Subsection 458.331(1)(m), Florida Statutes; placing Dr. Mationg on two years probation; imposing an administrative fine of $5,000; and requiring that Dr. Mationg attend ten hours of continuing medical education courses in the diagnosis and treatment of strokes and four hours of continuing medical education courses in risk management. DONE AND ENTERED this 3rd day of July, 2003, in Tallahassee, Leon County, Florida. S ___________________________________ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 2003. COPIES FURNISHED: James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 A. S. Weekley, Jr., Esquire Holland & Knight, LLP 400 North Ashley Drive, Suite 2300 Tampa, Florida 33602 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
