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.
The Issue Whether Proposed Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006, constitute an invalid exercise of delegated legislative authority?
Findings Of Fact Standing. The Petitioners, Medivision, Inc., and Tampa Surgi-Center, d/b/a Ambulatory Surgery Center, have standing to challenge the proposed rules at issue in these cases. See the affidavits of Larry Cyment and Donna McMillan. Intervenor, Florida Hospital Association, Inc., has standing to participate in these cases. See the affidavit of Pat Haines. The following Intervenors have established their standing to participate as intervenors in these cases through testimony or affidavit: Cataract Surgery Center, Cortez Foot Surgery Center, Ambulatory Surgery Center of Bradenton, Tampa Outpatient Surgical Facility, Naples Day Surgery, Ambulatory Surgical Center, Specialty Surgical Center and Tallahassee Single Day Surgery. Eye Surgery Center, The Eye Associates, FW Associates and Cordova Ambulatory Surgical Center have failed to prove their standing to participate in these cases. The Proposed Rules; Purpose and Adoption. The Health Care Cost Containment Board (hereinafter referred to as the "Board"), published Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006 (hereinafter referred to as the "Proposed Rules"), in Volume 16, Number 12, of the Florida Administrative Weekly (March 23, 1990). The purpose of the Proposed Rules is to collect data concerning the provision of ambulatory surgery services in the State of Florida. Data collected by the Board will allow a comparison of patient charges and will create an additional bases for the analysis of trends in the health care field. In particular, data collection will promote the analysis of shifts in the provision of health care from inpatient to outpatient settings. Data concerning patient identity, geographic location, diagnosis, procedures performed and charges for services is required to be collected and submitted to the Board pursuant to the Proposed Rules. In June of 1989, the staff of the Board presented a study to the Board concerning the growth of ambulatory health care services. Staff recommended that the Board direct that steps be taken to explore the possibility of collecting ambulatory surgery data. The Board accepted the recommendation and appointed a Technical Advisory Panel. The Technical Advisory Panel appointed by the Board consisted of nine representatives of various interested groups. Two members were from freestanding ambulatory surgery centers and two members were from hospitals providing ambulatory surgery services. At meetings of the Technical Advisory Panel in July, August, September and October, 1989, the collection of ambulatory surgery services data was considered. The Technical Advisory Panel discussed collection costs, the type of data to be collected, implementation dates, legislative authority, methods of submitting data and the scope of data collection. The Board was made aware of the Technical Advisory Panel's efforts through minutes of the Panel's meetings and other materials provided to the Board. The collection of ambulatory surgery services data was considered by the Board at its October, November and December, 1989, meetings. The Proposed Rules were approved by the Board at its December, 1989, meeting. There is no statutory authority which specifically provides that data may be collected by the Board from "freestanding ambulatory surgical centers." The Board cited Section 407.03, Florida Statutes (1989), as the specific authority for the Proposed Rules. The Board cited Sections 407.003, 407.03 and 407.08, Florida Statutes (1989), as the laws implemented by the Proposed Rules. Scope of the Proposed Rules. Ambulatory surgery services are provided in a variety of settings: hospitals (e.g., acute care, psychiatric and rehabilitation), licensed freestanding ambulatory surgery centers, physician offices and other unlicensed health care facilities. The Proposed Rules provide that all licensed hospitals included in Groups 1 through 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual which provide outpatient surgery services and all licensed ambulatory surgery centers in Florida are required to collect and submit 45 data elements to the Board. Psychiatric hospitals and rehabilitation hospitals are not subject to the Proposed Rules. Physicians' offices and other unlicensed health care providers are also not subject to the Proposed Rules. The Proposed Rules are limited to licensed providers of ambulatory surgery services so that the Board's staff can insure that all members of the groups selected data actually collect and report data. The Board cannot insure that all unlicensed providers of ambulatory surgery services, such as physicians' offices, comply with the Proposed Rules. Therefore, if data was required to be collected and submitted by unlicensed providers, the data would be less reliable. The weight of the evidence failed to prove that the requirement of the Proposed Rules that only hospitals included in Groups 1 and 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual and licensed freestanding ambulatory surgery centers collect and submit data constitutes an invalid exercise of delegated legislative authority. Specific Data vs. Aggregate Data. The Proposed Rules require the collection and reporting of 45 specific data elements. Aggregate data concerning ambulatory surgery services could be obtained from insurance companies and used by the Board as an alternative to the more specific data required to be collected pursuant to the Proposed Rules. Aggregate data is a compilation of specific data. Aggregate data can be used to comply with the Board's statutorily required functions. If aggregate data is used, however, it is likely that reporting will be incomplete. Not all information is reported to insurance companies concerning outpatient activity. Therefore, aggregate data obtained from insurance companies would not cover 100% of ambulatory surgery services provided by reporting entities, resulting in the potential for presenting an incomplete or inaccurate picture of ambulatory surgery services. The recommendations and conclusions which can be reached from aggregate data are limited. Specific data allows more flexibility for research purposes. Specific data will assure greater accuracy and comparability of data. Recommendations and conclusions reached from specific data should be more accurate. In order to insure comparability of data, specific data concerning patients, geographic location, diagnoses, procedures and charges must be collected. The Board collected aggregate data concerning ambulatory surgery services through a special study. The Board collected the data from hospitals and, on a voluntary basis, from licensed ambulatory surgery centers. "Typical" charges for specified ambulatory surgery procedures was collected. This collection effort was flawed by the lack of specific data. The accuracy of the reports based upon the aggregate data was criticized publicly. The reports were even criticized by one of the witnesses called to testify by Intervenors, Cataract Surgery Center, et. al. The weight of the evidence failed to prove that the requirement of the Proposed Rules that specific data be collected and submitted instead of aggregate data constitutes an invalid exercise of delegated authority. Confidential Patient Data. Some of the data elements to be reported pursuant to the Proposed Rules constitute confidential patient information. Disclosure of confidential patient information is prohibited by Florida law. The Proposed Rules do not require or authorize disclosure of confidential patient information. The manner in which the data collected will be distributed has not yet been decided upon by the Board. The evidence failed to prove that the Board will not comply with prohibitions against disclosure of confidential patient information. The weight of the evidence failed to prove that the requirement of the Proposed Rules that confidential patient information be reported to the Board constitutes an invalid exercise of delegated authority. Computer Use. The Proposed Rules require that data be submitted by computer tape or computer diskette. Therefore, data will have to be input into a computer system. The Proposed Rules specify the format data must be in when submitted. Most of the language of the Proposed Rules is computer terminology. The terminology of the Proposed Rules will require some knowledge of computers to carry out the requirements of the Proposed Rules. The language of the Proposed Rules is intentionally designed to convey technical information. The general purpose and requirements of the Proposed Rules does not take any special knowledge to understand. Requiring the submission of data by electronic means is designed to assure the accuracy and confidentiality of the data. The requirement of the Proposed Rules that data be reported in computer form and the use of computer terminology does not constitute an invalid exercise of delegated legislative authority. Errors in the Proposed Rules. Proposed Rule 10N-6.002(2) defines "Ambulatory Surgery Services" as procedures "provided in a hospital in its dedicated ASC ..." [Emphasis added]. Instead of "ASC" the Board intended to use the terms "operating room." Proposed Rule 10N-6.005 contains a list of the data elements to be collected and reported to the Board. This Proposed Rule contains the following errors or unclear language: Item 20 is "Facility Fee - Pri. Proc." "Pri. Proc." is an abbreviation for primary procedure. Items 21-24, similar to Item 20, contains the abbreviation "Sec. Proc." instead of secondary procedure. Items 25-27 contain a reference to "Page 3". As published in the Florida Administrative Weekly, there is no page 3. Item 35, which deals with expected methods of payment, refers to "Comm. Ins. (incl. BCBS)." This reference is an abbreviation for commercial insurance (Blue Cross Blue Shield). Item 44, patient birth date, uses the abbreviation "MMYYYY." This abbreviation should be "MMDDYY." Proposed Rule 10N-6.006 refers to "Primary Diagnosis Code" and "Secondary Diagnosis Code." The Rule should refer to Primary and Secondary "Procedure" Code. The mistakes identified in findings of fact 38-40 are not significant enough to characterize the rule as vague. Nor are these mistakes sufficient enough to otherwise conclude that the Proposed Rules constitute an invalid exercise of delegated legislative authority. Economic Impact. The Economic Impact Statement (hereinafter referred to as the "EIS"), issued with the Proposed Rules provided the following concerning the economic impact of the Proposed Rules on the Board: ESTIMATE OF THE COST OF IMPLEMENTATION: The agency will be affected by the costs of rule promulgation and by the demands placed upon staff time to assure compliance with the rules and to analyze the data collected. Costs for these activities are estimated to be approximately $85,000 per year. The weight of the evidence failed to prove that this portion of the Board's EIS is unreasonable. The EIS provided the following concerning the economic impact of the Proposed Rules on persons affected by the Proposed Rules: ESTIMATE OF THE COST OF IMPLEMENTATION: Implementation by affected facilities will cost approximately $2.9 to $3.1 million. These funds will be used to develop the programs necessary to collect and submit the data required. On-going compliance will have a much less significant impact. . . . . ESTIMATE OF COST TO ALL PERSONS DIRECTLY AFFECTED BY THE RULE: The initial cost to Florida hospitals and freestanding ambulatory surgery centers (ASC) would be from approximately $2.9 to $3.1 million to develop the reporting system necessary to generate the necessary data elements. On-going annual cost to the hospitals and free standing ASCs would be substantially less after the first year's start-up procedures are adopted. . . . . The EIS is insufficient because it does not adequately discuss the costs (implementation and ongoing costs) to affected persons or the impact of the Proposed Rules on small business. The weight of the evidence proved that the Proposed Rules will have an economic impact on affected persons. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the implementation cost affected persons can be expected to incur as a result of the Proposed Rules. As indicated in the EIS, the Board's determination of the estimate of the economic impact on affected persons was based upon surveys the Board distributed to licensed ambulatory surgery centers, an estimate of costs that hospitals incurred in implementing the Board's detailed patient data collection rule, the Board staff's experience with computer costs (including the collection and entry of data) and consultation with a computer expert familiar with the Proposed Rules. The surveys relied upon by the Board were distributed to all licensed freestanding ambulatory surgery centers. A total of 91 surveys were distributed. The Board requested that the surveys be returned within one week. Forty-one responses to the surveys were received by the Board from licensed freestanding ambulatory surgery centers. The responses constitute hearsay. Findings of fact concerning whether the information contained in the responses is correct, therefore, have not been made. The responses to the surveys have, however, been relied upon to make findings of fact concerning what information the Board based its EIS on. The Board received the following pertinent responses to the surveys from licensed freestanding ambulatory surgery centers: (1) 26 of the responders use computers, 12 have no computer capacity and 3 have some computer capacity; 17 or 18 different software programs are in use; and, (3) the costs to implement the proposed collection of data ranged from $0 to $50,000.00. Twenty- six responders indicated that they did not know how long it would take for them to implement the proposed collection of data. The Board determined that the average implementation cost for licensed freestanding ambulatory surgery centers reported in the responses to its survey was $18,975.00 and that the average implementation time was 13 weeks. The Board rounded up the average cost reported to it in the surveys and estimated that the cost of implementing the Proposed Rules at licensed freestanding ambulatory surgery centers would be $20,000.00. Based upon the existence of 85 licensed facilities, the Board estimated the total implementation cost for licensed freestanding ambulatory surgery centers to be $1,700,000.00 ($20,000.00 x 85). The Board estimated that the maximum cost of implementing the Proposed Rules at affected hospitals would be $2.00 per patient record. This estimate was based upon the Board's estimate of the cost of hospital compliance with the Board's detailed patient discharge data rule. Based upon an estimate of 600,000 patient records a year which will have to processed as a result of the Proposed Rules, the Board estimated the total cost of implementation in affected hospitals to be $1,200,000.00. The Board concluded that the total minimum cost of implementing the Proposed Rules will be $2,900,000.00 ($1,700,000.00 cost for freestanding ambulatory surgery centers plus $1,200,000.00 cost for affected hospitals). The Board discussed the cost of implementing the Proposed Rules with J. Thomas Solano, an expert in computers. Mr. Solano estimated that the cost of modifying an existing computer system (small to mid-range computer) to comply with the Proposed Rules would be $4,000.00 to $10,000.00. The Board used the highest estimate, $10,000.00, and multiplied this cost by the number of affected persons (85 freestanding ambulatory surgery centers and 220 hospitals x $10,000.00). This resulted in a rounded-up estimated implementation cost of $3,100,000.00. The Board concluded that the total maximum cost of implementing the Proposed Rules will be $3,100,000.00. Some of the data to be collected and reported pursuant to the Proposed Rules is already being collected by affected persons. Therefore, the primary cost of complying with the Proposed Rules will be associated with modifying existing computer software and/or hardware. The cost of modifying an existing computer system can fluctuate widely. As a general rule, computer users with existing software must rely upon their existing software provider to make modifications. The cost of modifying software can, therefore, be much higher than Mr. Solano estimated. As an alternative to modifying existing systems, affected persons can acquire a freestanding personal computer and software which can be used to comply with the Proposed Rules. The cost of such an acquisition should be approximately $2,500.00 to $5,600.00. Intervenor, T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it will have to spend approximately $14,000.00 to $20,000.00 to implement the Proposed Rules. This estimate is based upon a letter purportedly from the Intervenor's computer company. The information contained in the letter is hearsay. The estimated implementation costs are, therefore, not supported by admissible evidence. The estimate, even if supported by competent substantial evidence, is within the Board's estimated implementation costs and, therefore, fail to prove that the Board's EIS is unreasonable or that the Board failed to fully consider the economic factors or impact. Intervenor, Cataract Surgery Center, estimated implementation costs of $1,900.00. This amount is limited to additional maintenance fees, supplies and personnel costs. Cataract Surgery Center believes there will no charge from its computer vendor to modify its software. Cataract's estimated costs are reasonable and within the Board's estimates. Ambulatory Surgical Center of Lake County (hereinafter referred to as "Lake"), does not own a computer. It uses the computer system of its physician owners. Lake considered more than one method of complying with the Proposed Rules. It considered buying a personal computer and estimated it would cost $5,000.00. This cost is consistent with the estimates of the Board. Lake also considered purchasing an integrated hardware and software package. It estimated that such a system would cost $40,000.00 to $50,000.00. The estimate is based upon hearsay. Even if the evidence concerning the cost of an integrated system is accepted as correct, the evidence fails to prove that such costs are necessary to comply with the Proposed Rules. The estimate for this system is based upon Lake's decision that it would perform other functions with the computer system, including storing management information and performing billing functions. These functions are not required in order to comply with the Proposed Rules. Lake currently treats approximately only 300 patients annually. The weight of the evidence failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the implementation cost which will be incurred by affected persons. The weight of the evidence also failed to prove that the inadequate treatment of implementation costs in the EIS was fully considered by the Board. Therefore, the treatment of implementation costs in the EIS constitutes harmless error. Although the primary costs to affected persons caused by the Proposed Rules will be associated with implementation of the Proposed Rules, there will also be certain costs associated with ongoing compliance with the Proposed Rules. There will be ongoing costs for the collection of data, entry of the data into a computer and reporting data to the Board. Ongoing costs caused by the Proposed Rules will be greater if an affected person with an existing computer system acquires a freestanding computer system instead of using the existing system. The Board's statement in the EIS concerning ongoing costs was not based upon information from affected persons. The statement concerning ongoing costs does not indicate what the ongoing costs of compliance with the Proposed Rules will be. It only indicates that it will be less than the initial implementation costs associated with the Proposed Rules. Although the weight of the evidence did not prove the estimated total amount of ongoing costs to affected persons from the Proposed Rules, the weight of the evidence failed to prove that ongoing costs will be greater than the estimated total amount of implementation costs. T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it would incur ongoing costs of approximately $6,000.00. This estimate is reasonable. Cataract Surgery Center estimated that it would incur ongoing costs of $41,600.00, or $20.00 per case, to comply with the Proposed Rules. Cataract Surgery Center's estimated costs include the following costs: reel purchase; handling; reel preparation; collection of billing data; process of sending information to the Board; clarification of errors; additional record production; and response to public inquiries. Cataract Surgery Center's estimated costs are not reasonable. The estimated time to comply with the Proposed Rules is excessive and some of the tasks, i.e., collection of billing data, are not required by the Proposed Rules. Cataract Surgery Center's conclusion that it may have an increase in maintenance fees is reasonable. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the ongoing costs affected persons can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of ongoing costs in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the ongoing cost which will be incurred by affected persons. The EIS contains a statement that the Proposed Rules should have no economic impact on small business. In reaching this conclusion the Board failed to take into account the legal definition of "small business" contained in Florida Statutes. The Board did, however, actually consider the impact the Proposed Rules would likely have on small ambulatory surgery centers subject to the Proposed Rules. The Board attempted to reduce the economic impact on small ambulatory surgery centers by allowing affected persons to file data on computer tape or on diskette. By allowing the use of diskettes for reporting data, the Board made it possible for affected persons to use personal computers to comply with the Proposed Rules. Delayed submission of some data elements was also allowed in order to reduce the impact on small facilities. It is unlikely that the Board would have made further modifications of the Proposed Rules had the legal definition of "small business" been considered. The weight of the evidence failed to prove what, if any, reasonable modifications should have been taken by the Board to accommodate any economic impact on small business. The weight of the evidence failed to prove whether any of the entities that participated in the proceeding were small businesses. Those entities, although meeting the definition of small business with regard to the number of employees they have and their net worth, failed to prove whether they are "independently owned and operated." See Section 288.703(1), Florida Statutes (1989). The weight of the evidence failed to prove if any person affected by the Proposed Rules is a small business. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of small business which can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of the impact on small business in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated legislative authority because of the impact on small business. The Petitioners and Intervenors presented evidence concerning a number of actions which the Board did not take during its consideration of the economic impact and factors of the Proposed Rules and its preparation of the EIS. This evidence proved only that there were other steps which the Board could have taken during its preparation of the EIS. The Petitioners and Intervenors failed to prove, however, that the steps which the Board did take were not sufficient. The Petitioners and Intervenors therefore failed to prove that the steps which the Board did not take were required or necessary.
Findings Of Fact The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================
The Issue Whether Petitioner is entitled to a Certificate of Need ("CON") authorizing establishment of an (ophthalmological) ambulatory surgical center in Palm Beach County, Florida. Subordinate issues are: Whether the proposed facility satisfies the CON criteria of Sections 381.494-499, Florida Statutes, as implemented by Respondent, Department of Health and Rehabilitative Services ("HRS) rule and non-rule policy; Whether the proposed facility will result in unnecessary duplication of services, underutilization of existing services and increased health care costs to the community; Whether adequate resources are available for the construction and operation of the proposed facility; and Whether the proposed facility is financially feasible.
Findings Of Fact (Numbering corresponds to numbering used in proposed findings.) Preliminary findings: 1-4. Approved. On issue of compliance with applicable criteria: 1-7. Approved. 8. Approved, with caveat that this is subject to supplying an adequate record basis for the policy at hearing. 9-13 Approved. Approved but no presumption of correctness attaches to HRS earlier or more recent evaluation of the application. See, Boca Raton, supra. Approved. Approved but modified to more accurately reflect that HRS takes HMO's into account, but this factor was not used or relied on (in connection with the non-rule policy or standing alone) as the basis for granting Petitioner's application. Approved. 18-32. Approved, in the sense that an HRS expert witness at hearing offered conclusions as to compliance with each statutory criteria; rejected, in that his conclusions (except for those concerning quality of care, financial feasibility, the inapplicability of some criteria, and the cost advantages of modifying an existing facility instead of constructing a new one) are rejected as unsubstantiated by the facts. On the Issue of Need: 1-8. Approved. Approved. Modified to reflect that this is one estimate among several offered by experts. Rejected as unsupported by the credible evidence of record. Approved. Approved. First sentence, approved, in that this is the stated "attempt" of HRS' challenged non-rule policy. Second sentence, rejected as unsupported by the credible evidence; the profitable performance of outpatient surgery at a physician's office does logically compel a conclusion that his office should be licensed as an ambulatory surgical facility. On the issue of adequate resources: 1-8. Approved. On the issue of financial feasibility: 1-19 Approved. 20. Rejected as argumentative. RULINGS ON INTERVENOR'S PROPOSED FINDINGS 1-4. Approved. 5. Approved except for reference to equipment costs, of which there will be none. 9-16 Approved. 17. Such broad-brush incorporation of all facts asserted in argument is not susceptible to explicit rulings. RULINGS ON POST-HEARING MOTIONS. Intervenor's "Motion to Stay Issuance of Recommended Order" is denied. Intervenor's "Request for Hearing Officer to Take Official Recognition" of the Final Order of Hearing Officer Robert T. Benton II, in consolidated DOAH Case Nos. 85-2962R, 85-2963R and 85-3193R (attached to a "Notice of Supplemental Authority" dated November 1, 1985) is granted. The order is made a part of the record of this proceeding. A final order entered by another hearing officer of the Division of Administrative Hearings the authenticity of which is not in question, is an appropriate document to be accorded official recognition. See, Health Quest Realty XII v. HRS, 10 FLW 1729 (Fla. 1st DCA July 16, 1985, pet. for reh. pending). COPIES FURNISHED: Eric B. Tilton, Esquire 104 S. Monroe St. Tallahassee, Florida 32301 Theodore E. Mack, Esquire 1323 Winewood Blvd. Tallahassee Florida 32301 William B. Wiley, Esquire Post Office Box 2174 Tallahassee, Florida 32316
Recommendation Based on the foegoing it is RECOMMENDED: That Petitioner's application for a CON authorizing establishment of an ambulatory surgical facility at his offices in Palm Beach County, Florida, be DENIED. DONE and ORDERED this 15th day of January, 1986, in Tallahassee Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee Florida 32301 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of January, 1986.
The Issue The issue in this case is whether, under Section 57.111, Florida Statutes, Petitioner is entitled to attorneys' fees and costs incurred in the defense of a disciplinary proceeding.
Findings Of Fact On September 2, 1988, an 83-year-old female was admitted to West Orange Memorial Hospital with recurrent rectal bleeding and complaints of pain in the low back and left hip. The patient also reported pain while sitting or lying due to a subcutaneous nodule in the left buttock. As noted in the patient's history dictated by Petitioner on September 12, 1988, the patient had numerous admissions to the hospital for rectal bleeding and previously had been diagnosed as suffering from angiodysplasia. These notes also reflect that the patient had recently undergone a colonoscopy and upper endoscopy, which were negative. The notes of N. Alar, M.D., which were dictated on September 3, 1988, indicate that he had seen the patient in consultation for evaluation of lower gastrointestinal bleeding. The notes disclose that the patient had complained of bloody bowel movements. The notes record a history of diverticulosis and angiodysplasia of the colon. Following a colonoscopy and polypectomy, Petitioner excised the nodule on September 11. The procedure took place at the hospital bed of the patient where her left buttock was prepped and draped in sterile fashion prior to the making of a two-inch incision. Following the removal of the nodule, the area was cleaned, the wound was closed, and sterile dressing was applied. There was no break in technique during the procedureand sterility was maintained. The nodule was later determined to be an area of fat necrosis that had undergone dystrophic calcification. The following day, the patient developed severe respiratory distress and expired. Her final principal diagnoses were anemia secondary to gastrointestinal bleeding, arteriosclerotic heart disease, hypertension, and clostridium with septicemia. A Serious Incident Report was filed on November 29, 1988, and Respondent commenced an investigation on January 11, 1989, to determine if Petitioner's practice was below applicable standards. The first time that Petitioner's case appeared at a Probable Cause Panel Meeting of the Board of Medicine was on May 11, 1990. The following Panel members were present: Chair Robert Katims, M.D.; Marilyn Wells, M.D., and Gilbert Rodriguez. Also present were Assistant Attorney General M. Catherine Lannon and Respondent's attorneys, Carlos Ramos and Stephanie Daniel. At the commencement of the meeting, Ms. Lannon explained the respective roles of herself and Respondent's attorneys. In general, she was present to advise the Panel as to its legal duties under applicable statutes and rules. Respondent's attorneys were available to respond to questions involving specific investigations. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting insufficient time to review them. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file and Respondent's recommendation in the form of a draft administrative complaint or closing order, as appropriate. When Petitioner's case was announced, Mr. Ramos stated that Respondent recommended the Panel find probable cause and direct the filing of an Administrative Complaint. Mr. Ramos explained that the proposed Administrative Complaint alleged that Petitioner practiced medicine below the acceptable level of care when he excised a nodule from a patient's left buttock while the patient was lying on a hospital bed. Also, Mr. Ramos stated, medical records failed to reflect a rectal examination upon admission. Terming it a "terrible case," Panel member Wells moved to find probable cause and issue the Administrative Complaint. Mr. Ramos stated that Petitioner "wasn't sterile." Transcript of May 11 meeting, page 5. Chair Katims asked if Petitioner had surgical privileges. Ms. Lannon responded by restating Dr. Katims' question whether Petitioner may have performed the procedure in a hospital bed because he lacked surgical privileges. Dr. Wells expressed interest in this point. The motion was then passed without further discussion. The materials available to the Probable Cause Panel on May 11, 1990, included a letter dated March 15, 1989,from Joseph R. Goggin, M.D., who is a board certified surgeon. Retained by Respondent to opine as to the standard of care, Dr. Goggin reviewed the file materials and stated in part: I find it hard to believe that the patient's hospital bed in a usual hospital room would be considered sterile. [Petitioner's] statements throughout both the Discharge Summary and in the chart itself state that the wound infection clostridium perfringens and staph coagulase negative was self-inflicted by the patient following the surgical procedure. I cannot believe that this is true. Clostridium perfringens is not a normal flora found in the human colon. Neither is staph coagulase negative. I would suspect that if the patient had contaminated the wound with her own stool, we would have seen mixed cultures with numerous other bacteria involved. One must assume that because of the pure cultures of clostridium perfringens and staph coagulase negative that a break in sterile technique occurred. I think this occurred because the patient underwent the procedure in her hospital bed and not in a sterile operating environment. Dr. Goggin's letter concludes that the hospital changed its policy so that all procedures involving excision be performed in a "completely sterile environment." The letter adds: If this policy was not in place prior to the procedure, I don't believe that the licensee violated the standard of care as it applied to this hospital. However, most of us would believe that any invasive procedure of this nature should probably be performed in a sterile environment. The letter from Dr. Goggin also faults Petitioner for his failure to obtain a rectal examination upon admission of the patient, even though she had been complaining of rectalbleeding. In terms of the timeliness of Petitioner's diagnosis of clostridium, Dr. Goggin concedes, "I don't think that an earlier diagnosis would have changed this patient's final outcome." The records available to the Probable Cause Panel on May 11, 1990, also included a letter from Respondent to Petitioner advising him that he is the subject of a complaint and inviting him to provide a written explanation. In response, and included in the records available on May 11, were a letter dated April 25, 1989, from Petitioner; a statement dated April 25, 1989, from the attending nurse corroborating that sterility was maintained during the excision of the nodule; and a letter dated July 3, 1989, from James J. McClelland, M.D., whose letterhead indicates that he is a member of a group of infectious disease control consultants. Petitioner's letter states that invasive procedures, such as subclavian insertions, chest tube placements, and lumbar punctures for spinal taps, are commonly performed in the hospital bed. The letter restates the procedures followed to maintain sterility and asserts that the contamination had to take place subsequent to the dressing of the wound, such as by the patient inadvertently loosening the dressing through normal movement in the bed. Dr. McClelland's letter states that, following review of the medical records, he finds that Petitioner "followed the normal standard of care in performing this procedure . . .." The letter explains: [C]lostridial infections in sepsis are well reported in the literature to have occurred after many sterile procedures, using standard medical care and that the presence of the clostridial infection does not imply substandard care. It should be noted that clostridial organisms can colonize the skin, often times in higher numbers below the waist, and that this organism entered the wound in the postoperative period. The record showed that [Petitioner] followed the standard care to prevent contamination of the wound by his prep and subsequent dressing of the wound. In regard to the question con- cerning a break in sterile technique and the findings of pure cultures of Clostridium perfringens and staph coagulase negative, it could also [be] assumed that a break in sterile technique would result in multiple other organisms being present in the wound. It should also be noted that the Clostridium perfringens organism can colonize the gastrointestinal tract, as well as the skin, and in itself does not exclude this as a potential pathophysiologic mechanism for her subsequent sepsis. The potential for the woman to have developed this overwhelming infection, whether the surgical procedure was performed in the office, a hospital bed, or the operating room, all exist and cases have been reported associated with all settings. There is no evidence I can see that [Petitioner] deviated from what would be considered normal procedure in removing this nodule from the patient's buttocks. As a result of the deliberations of the Probable Cause Panel on May 11, 1990, Chair Katims executed a Memorandum of Finding of Probable Cause. In the memorandum, the Panel finds that probable cause was found of a violation of Section 458.331(1)(t) and (m). By Administrative Complaint filed August 24, 1990, commencing DOAH Case No. 90-5298, Respondent alleged that thesurgical wound on the left buttock developed pure cultures of clostridium perfringens and staph coagulase negative, "indicating a break in sterile technique." The Administrative Complaint alleges that the patient was admitted with rectal bleeding, but the records fail to disclose that a rectal examination was performed upon admission. The Administrative Complaint alleges that the hospital involved has since changed its policy to require all procedures involving excision to be performed in a "completely sterile environment." Based on the foregoing allegations, Count One of the Administrative Complaint alleges that Petitioner violated Section 458.331(1)(t) by failing to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician when Petitioner excised the nodule in the "environment of [the] patient's hospital bed, which is not a sterile operating environment." Count Two alleges that Petitioner violated Section 458.331(1)(m) by failing to keep medical records--namely a rectal examination upon admission-- justifying the course of treatment of the patient. On September 26, 1990, Respondent filed a motion to amend the Administrative Complaint to delete the allegation about the change in the hospital procedure as irrelevant. The motion was granted. On October 9, 1990, Respondent also filed responses to interrogatories. In support of the assertion that the hospital bed is not a sterile operating environment,Respondent stated that it would rely upon the following witnesses: Petitioner, the attending nurse, Dr. Goggin, and the medical records custodian. In their entirety, the responses disclose that Respondent had not obtained expert advice other than that set forth above. In response to a letter dated December 28, 1990, requesting an opinion and providing all file materials, Respondent's attorney Randolph Collette received a seven-page letter dated January 3, 1991, from E. Rawson Griffin, III, M.D. Dr. Griffin is Board-certified in family practice. After an extensive recitation of the patient history taken by Petitioner, Dr. Griffin traces the subsequent actions of Petitioner, noting that pathological examination of the biopsied tissue detected "no particular serious abnormalities." Dr. Griffin opines: . . . my first opinion is that overall I find that [Petitioner] followed the basic standard of care in doing a history and physical examination, writing progress notes which justified the treatment, provided a surgical procedure in which he documented proper sterilization, surgical technique and postoperative wound care and that he obtained proper informed consent and signed this informed consent. Based on this review, I feel that the standard of care which is outlined in DeGowan and DeGowan's as well as what any reasonable physician would follow, was pretty much followed. The only criticism that I can find is again that there are no progress notes which may have been made by the covering physician. I also found that it was interesting that [Petitioner] did do progress notes on days that other physicians did not and I felt that this indicated that he was following the patient properly. It should also be emphasized that he did a three page dictation which was a discharge summary which basically outlined the facts of the case and I found this discharge summary to adequately summarize the events as they had occurred. In answering specific questions posed to him by Respondent, Dr. Griffin responds affirmatively to the question whether Petitioner met the applicable standard of care in his examination, diagnosis, and treatment of the patient. Dr. Griffin opines that the bedside location of the procedure did not violate the applicable standard of care. In this regard, Dr. Griffin notes the cost-effectiveness of method of treatment, as well as the documentation of proper anaesthesia, preparation of tissue, proper technique, and proper sterile dressings. As to Petitioner's failure to perform a rectal examination, Dr. Griffin notes that a colonoscopy polypectomy was performed. Again referring to the DeGowan and DeGowan treatise, Dr. Griffin observes that, in some cases, a routine or basic examination is inappropriate. One of the primary purposes of a rectal examination is to detect rectal bleeding, but the patient presented with obvious signs of rectal bleeding. Dr. Griffin concludes that a rectal examination by Petitioner might not have produced any more information, so the trauma associated with repeated rectal examinations was unnecessary. Under the circumstances, Dr. Griffin opines that the records justify Petitioner's failure to perform a rectal examination upon admission of the patient. Dr. Griffin also discredits the findings of a Dr.Khouzan who, based upon what he described as a "very careful review of the chart," found "very severe purulent material." Dr. Griffin notes that this finding was contradictory to multiple other chart entries and concludes that Dr. Khouzan did not in fact examine the patient. Respondent's attorney Randolph Collette received a four-page letter dated January 8, 1991, from Stephen J. Nelson, M.A., M.D., whom Respondent had also retained for an opinion by letter dated December 28, 1990. Dr. Nelson is an Assistant Clinical Professor of Pathology at the University of Miami. He is also an Associate Medical Examiner for Broward County and Attending Neuropathologist. Acknowledging the receipt of relevant file materials, Dr. Nelson states: [The patient's] terminal hospital course is an example of anaerobic Clostridium perfrin- gens cellulitis, and probable myonecrosis, following surgery. The onset is sudden, dramatic, and often fatal with an incubation period of 6-72 hours. There are five types of Clostridium perfringens, A-E, separated according to their production of four major lethal exotoxins. The most important exotoxin is . . . (alpha) toxin, or lecithinase-C, because of its lethal, dermonecrotic, and hemolytic activity. Such wounds classically display no pus because the enzyme lecithinase attacks cell membranes and literally dissolves any and all cells (including inflammatory cells) that are in its path. Other Clostridial exotoxins include collagenase, protease, deoxyribonuclease, hyaluronidase, and a hemolysin. Bacteremia is present in about 15 percent of cases. [The patient's] wound is described in multiple places throughout her medical recordas having a serosanguinous drainage. A "thin blood-stained exudate" is the usual classic textbook description. I'm not sure what Dr. N. Khouzan was referring to . . . when he says that his "careful review of the chart revealed a very severe purulent material . . .." His review couldn't have been that awfully careful as there is no mention of "a very severe purulent material," and he incorrectly identified the species of Clostridium he was hoping to treat as being Clostridium tetany (sic) which causes tetanus, rather than Clostridium perfringens which was one of the organisms cultured from [the patient's] excisional wound (along with coagulase-negative Staphylococcal spp.). I can only hope that Dr. Khouzan is not an infectious disease specialist. . . . Dr. Nelson opines that the presence of Clostridium perfringens was not necessarily evidence of substandard care. To the contrary, Dr. Nelson finds that Petitioner, trained as an orthopedic surgeon, "adequately assessed and documented [the patient's] signs and symptoms." Additionally, Dr. Nelson states that Petitioner properly performed the excisional biopsy himself; although devoting his practice to family/general medicine, Petitioner was trained as a surgeon in orthopedics. The bedside site of the excisional procedure did not bother Dr. Nelson, who states that the operating room is "justifiably reserved for more complex procedures." Dr. Nelson questions whether the procedure was performed at bedside or in a nearby "procedure room," where it was scheduled to be performed according to one of the records provided to Dr. Nelson. Dr. Nelson explains that the procedure rooms can easily be prepared for sterile procedures like excisional biopsies. Dr. Nelson's letter concludes: Clostridial spp. are ubiquitous to the human body. They most often become disease-producing and self-perpetuating when the oxygen tension in tissues is lowered, as with an abscess, decubital ulcers, or other cause of tissue necrosis and/or devitaliza- tion. Debilitated patients are at a higher risk of developing Clostridial infections. Intestinal disorders, most commonly malig- nancies, permit Clostridium perfringens invasion and replication, resulting in severe local or, rarely, septicemic Clostridial disease. The most likely source of Clostridium perfringens in [the patient's] excisional biopsy wound is local fecal contamination, though systemic invasion cannot be absolutely ruled out. [The patient] could have developed the infection from an iatrogenic injury during the colonoscopy on 9/4/88 . . . from which the adenomatous polyp was snared. Or from [the patient's] long-standing diverticulosis with the infection spreading from the abdomen to the wound. These are unlikely scenario, given her medical history and hospital course, but it would have been an easy task to have ruled these out by the performance of an autopsy. On January 11, 1991, Respondent requested that the final hearing set for January 29, 1991, be cancelled and the case abated to allow Respondent to return the case to the Probable Cause Panel for reconsideration. In the absence of objection from Petitioner, the motion was granted and the case was abated until March 10, 1991. At the Probable Cause Panel Meeting of the Board of Medicine conducted on February 22, 1991, the following members of the Panel were present: Chair George P. Vitale; Fuad Ashkar, M.D.; and Margaret Skinner, M.D. Ms. Lannon was present, aswere Mr. Ramos, and Respondent's attorneys Larry McPherson, and Susan Londgard. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting in sufficient time to review them. Ms. Lannon then invited the Panel members to ask questions or request material if they encountered a case for which they had not read the materials or were otherwise unfamiliar with. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file. When Petitioner's case was announced, Mr. Ramos stated that the case was before the Panel for reconsideration after a previous Panel finding of probable cause and the subsequent filing of an administrative complaint. Mr. Ramos explained: We have brought this case back for your consideration, because discovery revealed that two expert opinions state that the Respondent's excision of the nodule in the bedside of the patient was not below the acceptable standard of care. Furthermore, the information related by the patients--by our expert as to the source of the patient's infection is contradicted by recognized medical treatises and the opinion of an infections disease control specialist, and that has been included in the packet. That came after discovery. And, therefore, the Department has recommended that we close this case without further prosecu- tion. Transcript of February 22 meeting, page 7. Panel member Skinner then indicated that she had noticed that the two expert opinions were from a Broward County assistant medical examiner and a family practitioner. She said that she would like to see an opinion from someone who is "Board certified in internal medicine with a subspecialty of infectious diseases, and I would like to see that . . . before we move to do away with this case. This case is heinous . . .." Id. at page 8. Panel member Skinner complained that the experts did not have any medical records and that her records were incomplete. For instance, she said that she did not know the size of the incision or if a nurse documented erythema or "crud" in the wound. She thus moved that the case be brought back with the medical records with an opinion specifically from somebody Board-certified in internal medicine with a sub-specialty in infectious diseases and be brought back to the Panel, because one of the things that is not in the [Administrative Complaint] is failure to recognize [Clostridium perfringens]. Id. at pages 8-9. Ms. Lannon responded that the standard of care would be a reasonably prudent similar physician, "so unless [Petitioner] was Board-certified in infectious diseases, he wouldn't be held to that standard of care. He would be held to the standard of care of a similar physician." Id. at page 9. Panel member Skinner answered that Petitioner is an "orthopedist practicing family practice." Id. Dr. Skinner then asked if Petitioner had surgical privileges at the hospital at which the incident took place. She suggested that the status of Petitioner's surgical privileges could be an "attributing cause." Id. Panel member Ashkar stated that he agreed with Dr. Skinner. Dr. Ashkar noted that one of the materials in the file indicated that the hospital had since changed its policies, or possibly had done so, in terms of excision procedures being performed in a completely sterile environment. In response to a question posed by Ms. Lannon, Panel members Skinner and Ashkar stated that they would proceed with an administrative complaint if they find "it's a standard-of-care violation." Id. at page 11. Dr. Ashkar added that a previous probable cause panel had good cause when it caused the filing of the Administrative Complaint, and the new panel should proceed with it. Dr. Skinner requested that the Administrative Complaint be expanded to include an allegation that Petitioner failed to recognize the presence or possible presence of a staph infection. Dr. Skinner conceded that she did not have the medical records, so she did not know if Petitioner did a wound culture. She also did not have the nurses' notes, so she did not know if they made if obvious that something was wrong with the wound. At this point, Mr. McPherson reminded the Panel that the case had been before a probable cause panel previously. He added that three expert opinions determined that there was "no standard-of-care violation." Id. at page 12. Ms. Lannon disagreed with Mr. McPherson, and Panel members Skinner and Ashkar agreed with Ms. Lannon. Dr. Ashkar stated that Dr. Goggin opined that there was a standard-of-care violation and that the incident forced the hospital to change their policies. Ms. Lannon cautioned that a change in policy would not establish a violation in the first place. Dr. Ashkar responded by referring to the standard-of-care issue and quoting Dr. Goggin as follows: ". . . the patient probably should have had the surgical procedure performed in a sterile environment under the usual conditions found in an operating room suite where there are sterile instruments, and that the wound infection here is probably due to doing it outside that kind of a setting." Id. at page 13. Ms. Lannon asked the Panel what they thought about Dr. Nelson's opinion that Petitioner could be regarded as overutilizing the operating room by performing the excision procedure there. Dr. Skinner admitted that the Panel's problem was that they did not know the size of the excision. She added that the experts differed as to the appearance of the wound, which went toward the failure to recognize a serious problem. Mr. Ramos suggested that the Panel table the case so that Respondent could provide the Panel with the medical records, which everyone agreed had not been included in thepackage supplied to the Board members prior to the meeting. Concluding their discussion of the case at the February 22 meeting, Panel member Ashkar rejected Dr. Nelson's opinion because, absent an emergency, Dr. Ashkar had "never heard of [performing the subject excision procedure in a hospital bed] recently ywayay." Id. at page 16. Dr. Skinner restated her concern about Petitioner's failure to recognize the complication. Ms. Lannon suggested that an orthopedic specialist who had examined the specialist possibly could provide needed information as to the size and nature of the nodule on the patient's hip. The motion was clarified to include consideration of amending the Administrative Complaint to include an allegation that Petitioner failed to recognize timely the patient's clostridium infection and to investigate whether Petitioner had surgical privileges. The Panel voted unanimously in favor of the motion and tabled the case. By Status Report filed March 5, 1991, Respondent advised that the Probable Cause Panel had tabled the case at its February, 1991, meeting in order to obtain additional information. At the Probable Cause Panel Meeting of the Board of Medicine conducted on May 4, 1991, Panel members present were Chair Vitale, Dr. Skinner, and Dr. Ashkar. Mr. Ramos and two of Respondent's investigators were present, as was Assistant Attorney General Edwin Bayo substituting for Ms. Lannon. Each of the Panel members indicated that he or she had read the file materials. When Petitioner's case came up, Mr. Ramos noted that the case had been in front of the Panel "a couple of times," most recently February 22, 1991. Transcript of May 4 meeting, page 4. Mr. Ramos added that one of Respondent's attorneys had pursued all the issues identified by the Panel at the last meeting. Mr. Ramos stated: Discovery reveals that the [Respondent's] expert's opinion was incorrect. That was the initial expert on which we depended on to file an Administrative Complaint. Dr. Nelson and Dr. Griffin have opined since then that the procedure performed in this case does not constitute the practice of medicine below the acceptable level of care. And at our last meeting, the Panel was informed on the foregoing, and it requested that an expert on infectious disease be obtained, and to obtain information as to the respondent's hospital privileges. There's two letters that are part of your packet from the hospital that says the subject did have hospital privileges. And as to the infectious disease person, the only person we have is the one on record, which is on the subject side of this case and [Respondent's attorney] tried to find someone. If you guys know someone for future reference, we need to know about it, because . . . Id. at pages 4-5. Panel members Ashkar and Skinner offered to provide Mr. Ramos with some names. Then Dr. Skinner confessed that she was still troubled about several things involving the case. She again raised the question why Petitioner failed to recognize the serious infection, clostridium perfringens. Sherestated the other issue concerning whether Petitioner was wrong to remove the cyst in the hospital bed. Addressing the first issue, Mr. Ramos said that Respondent could not obtain an expert opinion on whether Petitioner was culpable in his failure to recognize the infection. Dr. Skinner again offered to give Respondent the names of possible experts. Mr. Ramos responded that the process would take time, and, in the meantime, "we have this doctor in this position." Id. at page 6. Dr. Ashkar offered to contact the proposed expert and expedite the process, so the Panel could accept the expert's credentials at the next Board meeting at the end of May. Mr. Ramos said they could move fast on the case, so Dr. Skinner moved to table the case again. Dr. Skinner noted that they needed to consider the issue whether Petitioner improperly incised the abscess at the hospital bed. She asked that Respondent's attorneys pose to the expert two questions: was it below the standard of care to incise the abscess in the bed and was there a failure to recognize a potential danger. Dr. Ashkar distinguished between the removal of a nodule that is a simple ganglion, an ingrown hair, or a sebaceous cyst, on the one hand, and the draining of an abscess with a "very deadly bacteria in it in a general ward," on the other hand. Id. at page 8. Mr. Ramos answered that the case would depend entirely on the expert. The first expert was dated andcontradicted by treatises. Dr. Ashkar responded that it would have been more acceptable if a surgeon without access to an operating room performed the excision in a sterile setting other than an operating room. In any event, it was, in Dr. Ashkar's opinion, improper to perform the procedure in a general ward where infectious diseases are a recurring problem. Id. at pages 8-9. Dr. Skinner agreed that the situation was worse because Petitioner had operating privileges. Dr. Skinner then moved to table the case pending acquisition of expert witness, and again, . . . I would ask him all the ques- tions you asked the other expert witness. Noting that he did have operating room privileges. The second corner of the question that wasn't asked, is, is if it was failure to recognize an additional problem with this wound below the standard of care. Id. at page 10. The Panel then voted unanimously to table the case. Respondent filed a second Status Report on May 20, 1991, and advised that the Probable Cause Panel again tabled the case at its April, 1991, meeting in order to obtain an additional expert opinion. Petitioner objected to further abatement and requested that the case be dismissed. At the same time, Petitioner requested attorneys' fees and costs. By Order Setting Case for Hearing entered June 12, 1991, the request to dismiss was denied, the request for attorneys' fees and costs was denied, and the final hearing resetfor July 15, 1991. By Notice of Voluntary Dismissal filed June 18, 1991, Respondent dismissed the DOAH Case No. 90-5298 and the Division closed its file by Order entered the following day. On July 10, 1991, Respondent received the opinion of another expert, Stephen M. Kreitzer, M.D., who had been retained by letter dated June 26, 1991. In relevant part, Dr. Kreitzer's letter states: The bacteria [to which the patient succumbed] are present in the skin and certainly the elderly with diminished circulation to the skin are more prone to these types of infec- tions. These types of infections can certainly occur under the sterile conditions surgery or they can occur with any break of the skin on their own. It certainly is within the standard of care to remove the type of nodule removed by [Petitioner] in an outpatient center, hospital in-patient bedside, or in a physician's office. There is no evidence to suggest [Petitioner] violated Surgical Infectious Disease Guidelines. . . . Sepsis was recognized by the Emergency Room physician and the care of the septic patient was begun by the Emergency Room physician. [Petitioner] continued that care in the Intensive Care Unit. Appropriate cultures and the broadened spectrum antibiotics were prescribed. In my opinion, the patient contracted the Clostridium and Staph bacteria from unfortu- nate skin entry. Skin entry can occur from an intravenous site, or wound such as that involved with the nodule removal, joint injection by an Orthopedist which occurred during this hospitalization and finally, colonoscopy and polypectomy with mucosal contamination and septicemia. Bacteria induced septicemia have been documented in all of the above instances and is well recognized. . . . Because of the timing of this patient's sepsis, it is unlikely that the trigger point injection or colonoscopy had anything to do with the patient's subse- quent septicemia and demise. Regardless, there is no evidence in the chart that the patient contracted the infection because of the procedure or treatment falling below the standard of care. [Emphasis added.] The applicable standard of care comes into question with this case because of both record keeping and the admitting orders. The patient did not have a history and physical dictated at the time of admission, but rather that was delayed until the 12th of September. Although rectal exam was not included, since the admitting orders included the consultation with the Gastroenterologist who obviously would per- form the rectal exam and colonoscopy, the patient need not have undergone a rectal exami- nation necessarily upon admission. . . . Petitioner subsequently commenced the present case by filing a Petition for Costs and Attorneys Fees on July 29, 1991.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as the parties' stipulations of fact, the following relevant facts are found: The petitioner RHPC, Inc., d/b/a Riverside Hospital (Riverside) is licensed to operate a 102-bed general, acute care hospital located in New Port Richey, Pasco County. Formerly a public hospital known as West Pasco Hospital, Riverside was acquired by American Healthcare Management, Inc. (AHM) of Dallas, Texas, in December of 1983. By the prior issuance of Certificate of Need (CON) Number 2859, Riverside was authorized to construct and equip a new hospital building for patients and ancillary services at a cost of $14.8 million, including a special procedures room. The new building was approved for occupancy and use as a hospital in September of 1986. Riverside was able to complete construction and equipping of its new facility for an amount approximately $2.5 million less than the approved capital expenditure budget for CON No. 2859. Riverside now seeks to upgrade the existing equipment in its special procedures room so as to be capable of performing cardiac catheterization procedures. The room would not be a dedicated cardiac catheterization laboratory, but would serve the dual function of both cardiac catheterization and non-cardiac angiography. While the cost of creating a brand new cardiac catheterization laboratory would normally amount to approximately $1.4 million, petitioner proposes an expenditure of only $512,474. This lower figure results from the fact that Riverside's existing special procedures room was equipped during the renovation and reconstruction authorized pursuant to Certificate of Need Number 2859, and now needs only to be upgraded to achieve cardiac catheterization capacity. In 1982, prior to its acquisition by AHM, Riverside lost its accreditation through the Joint Commission on Accreditation of Hospitals (JCAH). The removal of accreditation was occasioned by code and physical plant deficiencies and documentation deficiencies related to quality assurance, infection control, medical record-keeping and staff credentialling. Riverside has attempted to eliminate all such deficiencies which led to the prior loss of accreditation. In September of 1986, Riverside submitted its application for a JCAH accreditation survey of its facility. As of the dates of the administrative hearing, the survey dates had not yet been scheduled. It generally takes JCAH approximately so days after a survey to render its accreditation decision. Riverside does not intend to offer cardiac catheterization services until JCAH accreditation is received by the hospital, and is willing to condition its proposed Certificate of Need upon receipt of such accreditation. Riverside has been certified by HRS for Medicaid/Medicare participation. While those conditions of participation are similar to JCAH accreditation standards, they are not identical. Riverside's active medical staff includes six board- certified or board-eligible cardiologists, none of whom currently perform cardiac catheterizations. There are no cardiovascular surgeons on staff, and Riverside does not immediately intend to offer open heart surgery at its facility. Approximately nine local cardiologists in Pasco County, including those on the medical staff of Riverside, have formed a corporation to promote and implement a quality assurance program for the catheterization laboratory at Riverside and to recruit and hire a board-certified cardiologist to perform the catheterizations. No specific physician has yet been recruited as catheteer. Riverside currently has on its staff certified critical care registered nurses and registered nurses with advanced cardiac life support (ACLS) training. It also has radiological support staff, staff trained-in photographic processing and staff available to handle blood samples and observe and monitor patients. It is expected that there will be cross-training at other AHM facilities having cardiac catheterization laboratories, such as St. Luke's Hospital in San Antonio, Texas. In addition to the cardiologists, Riverside intends to staff the proposed laboratory with one registered nurse, one radiology technician, a scrub technician and a technician responsible for the operation of the physiological monitoring during a procedure. The former two positions will be hired exclusively for the cardiac catheterization laboratory, and the latter two are already on the staff and will be assigned for catheterization procedures. Riverside currently offers the following noninvasive cardiac/circulatory diagnostic services: hematology studies, coagulation studies, electrocardiography (EKG), chest x-rays, blood gas studies, clinical pathology studies, blood chemistry analysis, nuclear studies pertaining to cardiology, echocardiography, pulmonary function testing and microbiology studies. Riverside proposes to upgrade its existing General Electric angiographic system with a new General Electric multi- purpose diagnostic system, and will also purchase a physiological monitor. A maintenance agreement will be purchased under which General Electric, which maintains an office in Tampa, will be responsible for maintaining the equipment. It is anticipated that a GE service technician will be on call, if not on site, during all cardiac catheterization procedures. GE also provides in-service training in the use of its equipment, and it is anticipated that GE training personnel will remain on site during the first several times the equipment is operated. Funds for the proposed cardiac catheterization laboratory are available through the prior financing arranged by AHM for the hospital reconstruction and renovation authorized by Certificate of Need No. 2859. Assuming that the proposed lab will perform 219 catheterization procedures at an average charge of $1,794 during the first year of operation, and 417 procedures at an average charge of $1,884 during the second year, Riverside projects a net income of $20,593 for year one and $117,288 for year two. The proposed charges are comparable to those of existing providers. The pro formas assume a payor mix of approximately 15 percent Medicare patients. Inasmuch as a large majority of patients requiring cardiac catheterization are elderly, the Medicare patient mix projections are probably low. Since Medicare does not generally fully reimburse a hospital for its actual charges, the net income projections are likely overstated. The pro formas do not include any expenses associated with a helicopter ambulance service. The expenses projected for employee benefits, seventeen percent of salary, appear to be a little low for the Pasco County area. Riverside anticipates that the net income generated from the proposed catheterization lab will also help offset and reduce the overall losses experienced by it in the past several years. HRS District V includes Pasco and Pinellas Counties. Although the HRS methodology for determining the numeric need for cardiac catheterization laboratories indicates, no additional need in District V, the parties have stipulated and the evidence demonstrates that there is a need for such a lab in Pasco County. The five existing catheterization laboratories in District V are all located in Pinellas County. There are currently no existing or approved labs in Pasco County, and approximately 1,200 Pasco County residents per year are being sent out of Pasco County for cardiac catheterization, mostly to Tampa General Hospital in District VI. The physicians who testified at the hearing would prefer to perform cardiac catheterization procedures and send their catheterization patients to a facility which also has open heart surgery capacity. When open heart surgery is necessary and a patient is referred or transferred to another hospital for such surgery, that facility often performs its own cardiac catheterization procedures. This results-in duplicate costs, services and potential risk to the patient who is cashed in one facility and referred to another facility for surgery. It has been the experience of local cardiologists in Pasco County that between 50% and 70% of patients upon whom a catheterization procedure is performed ultimately also have open heart surgery. Nevertheless, each of the cardiologists who testified indicated his desire and willingness to utilize Riverside's proposed laboratory for low-risk diagnostic cardiac catheterization procedures. Until Riverside is able to offer open heart surgery services at its facility (which is within Riverside's long-range plan)' it proposes to screen patients for risk, and perform only elective, diagnostic catheterization procedures. Neither pediatric, emergency nor therapeutic catheterization, such as balloon angioplasty, will be performed in Riverside's proposed cardiac cath lab. Three hospitals offering open heart surgery have entered into formal transfer agreements with Riverside. These include Morton F. Plant Hospital in Clearwater, Bayfront Medical Center in St. Petersburg, and Tampa General Hospital in Tampa. None of the three are within thirty minutes driving time from Riverside by emergency vehicle. Morton F. Plant' the closest of the three, is 27 miles from Riverside. During a "red run" or "hot run" with sirens and lights flashing, and following normal emergency driving procedures, it would take between 45 and 50 minutes for an ambulance to travel between Riverside and Morton F. Plant Hospital. There are large traffic volumes which utilize the road systems between Riverside and Morton F. Plant Hospitals, and a great number of lighted intersections. While petitioner presented testimony that an emergency vehicle traveling 10 miles per hour over the speed limit could reach Morton F. Plant from Riverside in 30 minutes, 18 seconds, such testimony is not deemed credible. The witness had not actually traveled that distance in an emergency vehicle. An actual emergency run was made from Tarpon Springs General Hospital to Morton F. Plant Hospital a distance of about 15 miles. That run, travelling a portion of the same route proposed by Riverside's witness, took about 22 minutes. Given the fact that Riverside is some 10 to 12 miles further away from Morton F. Plant Hospital than is Tarpon Springs General Hospital, it is concluded that an ambulance could not travel the 27 miles from Riverside to Morton F. Plant Hospital in 30 minutes in average travel conditions. Riverside does have a helipad at its facility, but does not own a helicopter and does not have a contract for air ambulance services. Although one of Riverside's witnesses believed that a helicopter would be at Riverside on all days upon which cardiac catheterizations are performed, no expenses for a helicopter or a contract with a helicopter ambulance service are included within Riverside's pro forma. Riverside intends to offer cardiac catheterization services 24 hours a day, seven days a week. While patients are generally directly charged for the actual costs associated with emergency transport, it is not reasonable to assume that the costs of either purchasing or maintaining an on-site helicopter could legitimately be directly charged to patients. The actual flight time from ground takeoff at Riverside to ground landing at Tampa General Hospital in average travel conditions is 15 minutes. There is a licensed air ambulance service, known as Suncoast, which operates out of Tampa International Airport and maintains two helicopters. Unless a hospital has a contract for air ambulance services, Suncoast does not dedicate a helicopter to be on standby and ready to respond to a call for an emergency flight. Even if a helicopter were available, it would take between 30 to 45 minutes to place a helicopter on the ground at Riverside after the need has been communicated to Suncoast. Given the fact that Riverside does not own or maintain a helicopter on site, it is reasonable to consider the time which could be expected to lapse between the summons for an emergency transport vehicle and its arrival, as well as the time of transport between two hospital facilities. Emergency runs, whether by ground ambulance or air transport, are tremendously stressful on a patient. This factor becomes particularly important when the patient is one who has recently undergone a cardiac catheterization procedure and is being transported for emergency open heart surgery. Even when patients are screened for risk, complications can arise during a diagnostic cardiac catheterization procedure necessitating an immediate transfer of the patient to open heart surgery or, in some events, a therapeutic catheterization procedure. Such complications include a possible artery dissection during insertion of the catheter or the occurrence of an eschemic episode as a result of the displacement of oxygenated blood with the dye injected into the coronary arteries. While these events are rare, occurring in possibly only 1% of all diagnostic procedures, they do necessitate immediate, more advanced treatment. The 1985-87 Florida State Health Plan favors co-located cardiac catheterization laboratories and open heart surgery programs in the same facility. Quoting from the Inter-Society Commission on Heart Disease Resources, the State Health Plan notes: ". . . there can be little justification for the development of these highly specialized facilities (cash labs) unless expertise in cardiology, cardiovascular radiology, and cardiovascular surgery are immediately available. Optimally therefore, catheterization laboratories should be located only in institutions with well organized and closely related programs of cardiovascular surgery. ". . . such an arrangement not only facilitates close interdisciplinary cooperation and minimizes unnecessary, repetitive, inadequate, or unsafe diagnostic studies, but it also allows prompt intervention should life threatening complications develop during catheterization studies . . . It should be emphasized . . . that separation of the diagnostic laboratory from the surgical facility is less than optimal and may present serious problems." (Riverside Exhibit 5, Volume II, pages 95-96). The State Plan recognizes that some within the medical community feel that independent, "satellite" labs can perform studies as adequately as labs associated with open heart surgery programs. However, it also recognizes the literature demonstrating that such independent labs usually have lower utilization rates. The District v Health Plan does not stress co-location, but suggests that cath labs be developed in areas which have the potential of justifying open heart surgery capability within three years. Other than considerations of timely access, there was no evidence that an additional open heart surgery facility is needed in District V or specifically, in Pasco County. The District Health Plan does stress the provision of services to the indigent. Riverside is committed to serving all patients regardless of ability to pay. Bayonet Point Hospital is a 200-bed hospital located in Hudson, also in Pasco County. In an earlier batching cycle, Bayonet Point applied for a Certificate of Need to add both a cardiac catheterization laboratory and open heart surgery at its Hudson facility. After an administrative hearing, it was recommended that the application be granted. (Division of Administrative Hearings Case No. 85-3569) The Department of Health and Rehabilitative Services rejected that recommendation by Final Order filed on August 22, 1986, and the matter is currently on appeal to the District Court of Appeal, First District. If Bayonet Point were to offer cardiac catheterization services at its facility in Hudson, a cardiac cath lab at Riverside would have an adverse impact upon Bayonet Point's program.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that Riverside's application for a Certificate of Need to equip and operate a cardiac catheterization laboratory at its hospital in New Port Richey be DENIED. Respectfully submitted and entered this 19th day of March, 1987, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of March, 1987. COPIES FURNISHED: Leonard A. Carson, Esq. and Robert P. Daniti, Esq. Carson & Linn, P.A. 1711-D Mahan Drive Tallahassee, Florida 32308 Darrell White, Esq. Assistant General Counsel Department of Health and Rehabilitative Services 1323 Winewood Blvd. Building 1, Room 407 Tallahassee, Florida 32399-0700 Thomas M. Beason, Esq. and Donna H. Stinson, Esq. Moyle, Flanagan, Katz, Fitzgerald & Sheehan 118 North Gadsden Street Tallahassee, Florida 32301 Gregory L. Coler, Secretary Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power, Clerk Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 APPENDIX The proposed findings of fact submitted by the petitioner, respondent and intervenor have been fully considered and have been accepted and/or incorporated in this Recommended Order, except as noted below. Petitioner 16. First sentence rejected as contrary to the evidence. 27. Last sentence rejected insofar as it contemplates the reasonableness of the pro forma with regard to the Medicare patient mix and the failure to include expenses relating to an air ambulance. 38,39. Rejected. Failure to account for a proper payor mix and air ambulance service renders the financial feasibility projections unreliable. Rejected. Only the JCAH can render such a factual finding. Last sentence rejected as unsupported by the record of this proceeding. See Order denying second motion to reopen record. Rejected as to travel time. Not supported by competent, substantial evidence. Accepted only insofar as it pertains to actual patient flight time. Rejected as not supported by competent, substantial evidence. Second sentence rejected as speculative. Last sentence rejected as unsupported by competent, substantial evidence, although it is recognized that Riverside intends to offer only diagnostic procedures. Last sentence rejected as an absolute statement of fact. Not supported by competent, substantial evidence. 64. Second sentence partially rejected as contradicted by competent, substantial evidence. See Finding of Fact 10 in this Recommended Order. Respondent HRS 20. Rejected insofar as it applies to all ambulance drivers. Not supported by competent, substantial evidence. Intervenor Bayonet Point 5. Rejected as irrelevant and immaterial. Fourth sentence is rejected as not supported by competent substantial evidence. Third sentence partially rejected. See Finding of Fact Number 11. 16. While accepted as an accurate statement of fact, it is concluded that such considerations should not be included within the 30 minute travel time rule. 17,18. Rejected as irrelevant and immaterial to the issues in dispute. First sentence accepted as factually correct but not determinative of the reasonableness of the pro formas. First sentence accepted as factually correct but not determinative of the reasonableness of the pro formas. 22,23. Partially rejected as speculative and unsupported by competent, substantial evidence. Rejected as an improper finding of fact, as opposed to a conclusion of law after considering the factual circumstances. Accepted only if the words "if approved" are added.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 10th day of February, 2000.
