The Issue The basic issue in this case is whether Deering Hospital's application for a certificate of need to operate an inpatient cardiac catheterization program should be granted or denied.
Findings Of Fact Deering Hospital, formerly known as Coral Reef Hospital, is located at 9333 Southwest 152nd Street, Miami, Florida, in HRS District 11, Dade County. Deering Hospital has a total of 260 beds: 170 medical/surgical, 54 adult psychiatric, 16 adolescent and child psychiatric and 20 substance abuse beds. It is an acute care hospital. Deering's primary geographic service area is north to the town of Kendall, west to the Everglades, east to Biscayne Bay and south to 232nd Street. The secondary service area is south to the Florida Keys. Deering's primary service is defined by 62 percent of its admissions, its secondary service area by 17 percent, and all other areas, including North Monroe County, comprise 21 percent of all its admissions. Competitors in Deering's primary and secondary service areas include Kendall Regional Medical Center, Baptist Hospital, South Miami Hospital, and South Miami-Homestead Hospital, which was previously called James Archer Smith Hospital. These hospitals have shared a service area as long as they all have existed. South Miami-Homestead Hospital does not have a cardiac catheterization laboratory. Deering is within 30 minutes travel time of three full service cardiac catheterization programs located in facilities with open heart surgery, including two of the challengers to its application. On June 18, 1990 South Dade Health Care Group, Ltd., was formed in order to acquire Coral Reef Hospital. South Dade Health Care Group, Ltd., at the time of the application was and is currently licensed by HRS to operate Deering Hospital. Columbia Hospital Corporation of South Dade ("Columbia') is the general partner of South Dade Health Care Group, Ltd. Columbia, acting on behalf of South Dade Health Care Group, Ltd., acquired Coral Reef on September 26, 1990. Coral Reef changed its name to Deering Hospital on April 2, 1991. Deering's CON application in this batch cycle was submitted on March 25, 1991. The June 18, 1990, audited balance sheet for South Dade Health Care Group, Inc., was prepared for a development stage enterprise and is an audit of costs to start up the hospital after the acquisition by Columbia. The December 31, 1990, audit covers a 97 day period from September 26, 1990, (date of acquisition) to December 31, 1990, and included development and organizational costs. Since the applicant/entity/licensee did not exist before June 18, 1990, and the hospital was not acquired by that entity before September 26, 1992, there are no other financial statements that could have been prepared before the Deering application was submitted on March 25, 1991. South Dade Health Care, Group, Ltd., submitted a timely and valid letter of intent and a timely application for Certificate of Need ("CON") 6664 to provide in the July 1993 planning horizon inpatient cardiac catheterization services at Deering Hospital. South Dade Health Care Group, Ltd., and Columbia have authorized Deering Hospital's participation in this case. The capital projects list in the application is complete. When Deering was purchased by Columbia in 1990, Deering had a special procedure room that was apparently equipped and had the capacity to provide diagnostic coronary catheterizations as well as peripheral (i.e., the extremities) vascular diagnostic and therapeutic procedures. Although outpatient catheterizations had been performed in the special procedure room in the past, none were being done when Columbia acquired the hospital in September 1990. In late 1990, following evaluation of the equipment, Deering recruited an experienced CCRN cardiac catheterization laboratory nurse, hired a qualified CV tech, and began offering outpatient cardiac catheterization services. The decision to begin outpatient cardiac catheterization services was based in part on the idea that there would be no capital costs since the equipment to perform the procedures already existed. In December of 1990, the existing outpatient cardiac catheterization laboratory did about nine procedures and experienced some equipment failures. As a result of the equipment failures, Deering temporarily stopped doing outpatient cardiac catheterization, but was able to continue doing special procedures (vascular and arterial catheterizations, not coronary) in the room. After exploring various possibilities, Deering entered into a lease to obtain new equipment for its existing outpatient cardiac catheterization laboratory and signed a renewal lease to continue the lease of the equipment that was already in the outpatient laboratory. In January of 1992 the hospital resumed doing outpatient cardiac catheterization procedures and ten outpatient cardiac catheterizations have been performed in the room since January 31, 1992. From 1985 through April of 1991 the Deering outpatient cardiac catheterization program has done a total of twenty-nine outpatient procedures. The lab was closed temporarily to outpatient cardiac catheterization procedures from March 1991 through January 1992 in order to bring in new equipment. The hospital has been diligent and persistent, from the date Deering was acquired by Columbia to the present, in its efforts to maintain and enhance its outpatient cardiac catheterization program. Currently, however, if a Deering inpatient needs a cardiac catheterization, that patient must be taken past an active outpatient catheterization laboratory at Deering, only to be transferred to another hospital with an inpatient cardiac catheterization certificate of need. In health planning, it is generally desirable to use existing facilities and equipment to do additional procedures. By its application in this case, Deering proposes to use its existing outpatient cardiac catheterization laboratory to perform inpatient cardiac catheterization. For calendar year 1991, about 50 cardiac catheterization inpatients were transferred from Deering to other hospitals. Patients requiring inpatient cardiac catheterization or open heart are transferred from Deering to South Miami Hospital, Baptist Hospital, or Kendall Regional Medical Center. At Deering the spatial relationships between the existing outpatient cardiac catheterization laboratory and related services such as telemetry and intensive care appear to be adequate. Deering has 16 telemetry beds and they can be easily increased if needed. An uncomplicated inpatient cardiac catheterization typically results in one day in telemetry. Deering has ample capacity for over 300 additional telemetry patient days. At Deering the intensive care unit and the coronary care unit are collectively referred to as the critical care service (CCS). Deering has 14 CCS beds where a patient can be directly connected to a cardiovascular monitor allowing monitoring of any clinical changes. The current CCS average daily census is ten (10). Deering's application is not by or on behalf of an HMO. No evidence was presented to show that HMO's in District 11 have unmet cardiac catheterization needs or that Deering's application would fulfill any needs of HMO's. To the contrary, HMO's have a tendency to prefer cardiac catheterization services at facilities with open heart surgery. Typically an uncomplicated diagnostic cardiac catheterization does not require a CCS stay. Even if 50 percent of Deering's cardiac catheterization inpatients required CCS during their stay, Deering has the capacity to accommodate the 150 additional CCS patients annually. The physical space which comprises the existing outpatient cardiac catheterization laboratory is clinically adequate in its current configuration to facilitate communication during the procedure and time savings. The dark room, computer room and procedure room are all adjunct. There are no medical or clinical reasons why the space is not adequate. According to the medical director, who has extensive experience at other hospitals and who has performed outpatient cardiac catheterizations in Deering's procedure room, Deering's procedure room is more than adequate for performing inpatient cardiac catheterization. If the inpatient certificate of need is granted, the procedure room where outpatient catheterizations are currently performed will continue to be a mixed used room, i.e., peripheral angioplasties and coronary catheterizations will be scheduled in the same room. Deering Hospital is JCAHO accredited. It received a three year accreditation in 1991. The laboratory currently used for outpatient procedures was surveyed by JCAHO as a special procedure room. Deering has never been cited in any JCAHO or HRS licensure survey for any inadequacy in life, safety, or fire codes in the outpatient cardiac catheterization special procedure room. Deering currently has all of the equipment, staff and ancillary services described in, and required by, the applicable rule. Deering has two physicians on staff that serve and are compensated as co-directors of the existing outpatient cardiac catheterization laboratory. Dr. Palomo is co-medical director of the existing outpatient cardiac catheterization program and will be co-medical director of the inpatient program if the program is approved. Dr. Palomo is Board certified in internal medicine and Board certified in cardiovascular diseases. He was previously an assistant professor of medicine at the University of Miami and ran the cardiac catheterization lab at the Veteran's hospital in Miami. Last year Dr. Palomo performed 300 cardiac catheterizations in the Miami area. Dr. Palomo has cardiology staff privileges at six Miami hospitals, including two of the challengers to this application, Baptist Hospital and South Miami Hospital. He lives ten minutes from Deering Hospital and his office is located eight minutes from Deering. There is no industry standard for credentialing cardiac catheterization laboratory nurses, but it is generally agreed that all cardiac catheterization personnel should be ACLS trained. All Deering nurses who are cross-trained for the cardiac catheterization laboratory are ACLS certified. Deering has also cross-trained an ECHOvascular technician into the scrub roll in the laboratory. All current cardiac catheterization laboratory staff and all cross-trained cardiac catheterization laboratory staff are already full time Deering employees. Current staff can accommodate the projected volume of inpatient cardiac catheterizations and the current rate of peripheral and outpatient catheterizations. If awarded the service, Deering would be able to implement the service the day of the award. The current staff is adequate regardless of whether they are performing an inpatient, outpatient, or peripheral procedure. The staffing of the inpatient lab would be the same as the current outpatient laboratory; i.e., a physician, RN and a CVT. There would not be any need to add staff if the number of procedures increased between 300 and 1,000 annually. Accordingly, Deering does not intend to recruit additional professional personnel from the local market. The capacity of Deering's existing laboratory, when used for inpatient cardiac catheterization procedures, can conservatively be calculated as follows: 1 hour from arrival at the procedure room to departure from the procedure room, times an 8 hour day, times a 5 day week, times 52 weeks a year equals 2,080 case theoretical capacity. One-half that theoretical capacity is four cases a day or 1,040 cases a year. A cardiac catheterization laboratory can typically do between 1,000 and 1,500 cases per year. Four cases per day (1,040 cases per year) is a reasonable number to express the capacity of Deering's existing laboratory to accommodate inpatient procedures with current space, equipment and staff. The existing inpatient cardiac catheterization laboratories in District 11 have similar capacities. With additional staffing, Deering or any of the existing laboratories might have even greater capacities. If granted inpatient cardiac catheterization services, Deering would not do coronary angioplasties because it does not have open heart surgery in the same facility. Deering maintains transfer agreements with other facilities for services that Deering does not provide. Deering has developed an adequate protocol outlining how an open heart or angioplasty backup patient would be transferred. Deering has established medically appropriate criteria for granting and maintaining privileges in its outpatient cardiac catheterization laboratory that would be suitable for the proposed inpatient cardiac catheterization program. Deering has developed adequate and appropriate forms to manage its patient care in the outpatient program which would be suitable for the inpatient program. Deering has developed clinically adequate and appropriate protocols for temporary pacemaking, recording hemodynamic data, and insuring the emergency availability of staff in the cardiac catheterization laboratory. Deering has a policy and procedures statement to orient new employees to the cardiac catheterization laboratory. Generally, there is no alternative to cardiac catheterization when catheterization is medically indicated. However, there are alternatives to Deering's application, such as allowing existing providers to achieve efficient levels of utilization. Deering is not proposing joint, shared, or cooperative health care services. Deering is not proposing to provide services for research or teaching purposes. Deering does not propose to provide a substantial portion of its services to individuals not residing in the service district. Indeed, inpatient cardiac catheterization services are readily available in adjoining service areas. Deering is not proposing any new construction in its application. Deering is not proposing to add nursing home beds. No service reductions will occur as a result of this proposal. Financial feasibility of a project means the project can be accomplished within the financial resources of the overall institution. Short- term financial feasibility means the applicant can cover the start-up project costs. Long-term financial feasibility means the project will generate a surplus of operating revenue over operating expenses within two years. The proposed project would most likely be financially feasible in the short and long-term, even though (for reasons addressed below) it is unlikely to achieve the results projected in the pro formas. This is because Deering is already operating an outpatient cardiac catheterization laboratory and would have very little additional expense if it began performing inpatient cardiac catheterizations using the existing staff and the existing equipment. If the project were to be approved, the hospital as a whole would probably have a positive cash flow in the first and second year, because with a mere four or five inpatient procedures it would recover the additional costs associated with converting the existing outpatient lab to an inpatient lab. A contribution margin is the difference between the variable expenses and variable revenues on a per unit basis or in the aggregate. For additional inpatient cardiac catheterization services on a per case basis, Deering projects a positive contribution margin of $2,500 per procedure. This is similar to the contribution margins of other hospitals performing inpatient cardiac catheterizations in Deering's service area. Break-even analysis determines how many procedures must be done before incremental fixed costs are covered. Since incremental fixed costs are $10,000, after only 4 or 5 inpatient procedures the service would break-even. For a number of reasons mentioned below, it is very unlikely that Deering would be able to achieve its projected utilization levels. Specifically, it is unlikely that Deering would be able to achieve a utilization level of 300 admissions per year by the end of its second year of operation. The analysis on which Deering bases its much higher utilization projections appears to be flawed in several respects and is also contrary to reasonable expectations based on the average historical performance of diagnostic-only cardiac catheterization programs in District 11. In an effort to demonstrate that Deering would perform in excess of 300 procedures per year, Deering's health planning expert, undertook the following analysis: The number of MDC-5 (circulatory diagnoses) at Deering in 1990 was approximately 750. It was assumed, from data in the Winslow report and the Dade County actual data that one third of the MDC-5 admissions would receive a cardiac catheterization. Multiplying 750 times one third results in 250 admissions at Deering who would receive a catheterization, or approximately 20 per month. Because some people would refuse to have a catheterization, or would undergo it at another facility, it was assumed that 17 patients per month, or approximately 195 per year, would be cathed at Deering in the first year of operations. It was assumed that the growth at Deering between year one and year two of operations at Deering would be equal to the projected growth in catheterizations in Dade County between July, 1989 and January, 1994. It was assumed that all of the cases projected above would be inpatients. Based on this analysis, it was projected that Deering would be able to do in excess of 300 cases per year starting in its second year of operations. The greater weight of the evidence indicates that this methodology suffers from a number of flaws. The "one third" factor applied in step 2, above, is erroneous and was incorrectly applied even if correct. The Winslow paper provides no support for the proposition that one third of all MDC-5 admissions will require catheterization. The actual statistic from Dade County is that all inpatient catheterizations, including those done in anticipation of open heart surgery and for angioplasty, constitute 21 percent of the number of MDC-5 admissions. Of the catheterizations done in Dade County, 9 percent (1,382 catheterizations out of a total of 16,155) were performed in conjunction with open heart surgery and 16 percent (2,700 of 16,155) were angioplasties. Because Deering will be unable to do either open heart surgery or angioplasty, a full 25 percent of the catheterization case load is unavailable there. Applying the 21 percent factor (percent of actual inpatient catheterizations to MDC-5 admissions) would result in 158 potential catheterizations. Dropping out 25 percent of those (the percent requiring open heart surgery and angioplasty) results in 118 potential cases. Using then the 85 percent figure (to reflect those who refuse to be catheterized or must go elsewhere because of managed care agreements, etc.) leaves approximately 100 inpatient cases in the first year, or roughly half of what Deering projects. There is no persuasive support for the idea advanced by Deering that its growth between year one and year two of operations would be the same rate of growth that all Dade County providers experienced between 1989 and 1994. To the contrary, such an experience is most unlikely. First, the projected rate of growth assumes that Dade County's use rate will continue at the same rate. This is optimistic. Second, it assumes that Deering will reflect the growth in the number of cardiac catheterizations in Dade County even though it is only providing diagnostic catheterizations (i.e. no angioplasties or catheterizations during open heart surgery). Finally, it assumes that Deering's rate in providing cardiac catheterizations will be the same as four and one half years experience in Dade County. If the actual annual rate of increase in Dade County were applied to Deering's own projected first year utilization, it would still only be likely to do 230 cases in the second year. The actual number of patients transferred from Deering for inpatient catheterizations plus its actual number of outpatient procedures provides a more accurate guide to the number of cases Deering could be expected to do. Based upon these figures, Deering might be expected to do between 70 and 150 cases the first year and less than 200 the second. One assumption made by Deering to support its utilization projections was that there would be a growth in the utilization of cardiovascular services at Deering. The historical use pattern at Deering fails to reveal any trend that would suggest such an increase. According to data reported to the HCCCB, there was an overall decline in the number of intensive care days at Deering between 1985 and 1991. Similarly, emergency room visits have also declined during the same period. Emergency room admissions account for 60 percent of all admissions to Deering. As a result, the total number of patient days at Deering has declined from 47,089 in 1985 to 40,975 in 1991. Thus, although Deering is projecting a large increase in utilization to project satisfactory utilization of its proposed laboratory, the historical record does not support that record. According to Deering, indicators of cardiac volume include the following services: EKGs; echocardiograms; holter monitors; treadmills; pulmonary function tests; thallium exams; and, coagulation studies. According to data presented by Deering, none of those "cardiac volume indicators" showed an increase in utilization between 1988 and 1990. In its financial analysis, Deering assumed that all of the 195 procedures in the first year and all 360 in the second year would be inpatient procedures. In Dade County for the 12 months ending September 30, 1991, 39 percent of all catheterizations were done on an outpatient basis (6,240 outpatient procedures out of 16,165 total cases). That percentage would be even higher at facilities that are unable to provide open heart surgery. (For example, currently 80 percent of the cardiac catheterization procedures at Doctors' Hospital are outpatient procedures.) In all of Florida approximately 50 percent of all cardiac catheterizations are inpatient. The trend in Dade County, in Florida, and nationally is that the number, and percentage, of outpatient procedures is increasing. The significance of this fact as it relates to Deering's financial projections is that Deering did not make any adjustment in its utilization projections to account for outpatient utilization and projected the pro formas by assuming that income associated with each case would be the income associated with a full inpatient admission. Thus, the pro forma projections are overstated to the extent that the projected procedures will actually be performed on an outpatient basis. At least 35 percent of Deering's procedures are likely to be on an outpatient basis with the trend indicating that outpatient utilization will actually be much higher. In projecting the average length of stay to be attributed to each inpatient catheterization at Deering, it was assumed that it would be the same length of stay as the District 11 average. The District 11 average includes the average inpatient stay associated with open heart surgery, which is much longer than for a routine diagnostic catheterization. Thus, Deering has overstated its projected average length of stay. In addition, the average length of stay for inpatient catheterizations has been dropping. This compounds the extent to which the number of inpatient days associated with catheterizations has been overstated in Deering's pro formas. One assumption in Deering's financial analysis is that patient days at Deering would increase at the same rate as the population increase in Dade County. This assumption finds no support in the evidence presented at hearing. In fact, it was demonstrated that the actual number of patient days have been declining at Deering since 1985. In 1985, Deering has 47,089 patient days; in 1991 it had 40,975 patient days, a drop of 13 percent. This drop occurred even though Dade County has had continuous steady growth. The financial assumption that Deering's inpatient days will grow at the same rate as the population as a whole is found to be unsupported. One reality check of Deering's projection that it will perform in excess of 300 procedures in its second year of operations is to measure its proposed "capture rate" against that of the other hospitals it will be competing against. In 1990 there were a total of 491 cardiac catheterizations performed on patients who reside in Deering's primary service area. Of these, Baptist, which is a full service provider, was able to capture only 203 cases, or 41 percent. If Deering, with one catheterization lab which is also used to do peripheral procedures, were to capture 300 procedures from its primary service area, this would represent in excess of 60 percent of the procedures from that area, or one and one half times better than Baptist is able to do with a full service catheterization facility, three dedicated catheterization laboratories, four full catheterization teams, and angioplasty and open heart capabilities. It is most unlikely that Deering can achieve such a projection. Deering proposes to provide a diagnostic-only program. Of the 13 cardiac catheterization programs in Dade County, nine are traditional and four are diagnostic-only. The diagnostic-only laboratories in District 11 have historically operated at significantly lower volumes than the laboratories in facilities with open heart surgery. During calendar year 1991 the four diagnostic-only providers performed the following number of procedures: Doctors' Hospital 301 Humana Hospital-Biscayne 55 Palmetto General Hospital 432 Parkway Regional Med. Center 262 TOTAL 1050 The total of 1050 procedures constitutes an average of 262.5 procedures for each of the four existing providers. If this pool of 1050 procedures were to be divided five ways to accommodate a new provider, there would be an average of 210 procedures per diagnostic-only provider. It would require an increase of almost 50 percent in the number of procedures being done by diagnostic-only laboratories for five such laboratories to be performing an average of 300 procedures per year. This is yet another reason for which it is most unlikely that Deering would achieve the utilization levels it projects. There appears to have been little physician acceptance of the outpatient catheterization laboratory at Deering. From 1985 through the date of hearing, Deering only performed 29 cardiac catheterizations. Dr. Palomo is the medical director of the Deering cardiac catheterization laboratory. One of his duties as medical director is "promoting" the laboratory. In 1992, through June 16, Dr. Palomo performed only two or three cardiac catheterizations at Deering; in calendar year 1991, he did four to six cardiac catheterizations at Deering. Dr. Palomo does approximately 300 catheterizations per year. It is unlikely that Deering will perform over 300 catheterization cases per year when its own medical director is doing less than 2 percent of his cases there. South Miami is an acute care hospital located in Dade County. South Miami has a open cardiac catheterization program which means any physician within the community can apply for privileges, and, if granted, perform cardiac catheterizations at South Miami. Until recently, it was a closed program. Baptist is a large, full service acute care hospital located in South Miami, Dade County, District 11. Baptist provides a full array of cardiac services at its Miami Vascular Institute. These include cardiac catheterization, open heart surgery, and angioplasty. Baptist is within the primary service area of Deering. It is approximately eight minutes drive from Deering. Deering currently transfers its cases needing inpatient catheterizations to other hospitals, including Baptist. If Deering were to be approved, and if it were able to perform 360 cases in its second year of operations as it projects, it would most likely be performing something in the neighborhood of 150 cases that otherwise would have been done at Baptist. 3/ This was calculated as follows: There were a total of 491 catheteriza- tions performed in 1990 on patients residing in Deering's primary service area. Of those 491 cases, Baptist performed the catheterizations for 203 patients. If Deering were to perform 360 inpatient catheterizations in its second year of operations, it is projected that Baptist would lose cases in the same relation as its current market penetration, i.e. 41 percent. This equates to 149 cases. This methodology presents a reasonable projection of the number of cases that Baptist would be likely to lose if Deering's application for inpatient cardiac catheterization were approved and Deering were able to achieve its projected utilization levels. Baptist has a contribution margin of approximately $2,560 per cardiac catheterization. This figure is the average revenue per case less the variable costs per case. Using the methodology described above, it is projected that the net annual loss at Baptist, if Deering were approved, would be in the neighborhood of $380,000.00. If Deering were to achieve its projected utilization levels, it is likely that it would also be performing a substantial number of cases that otherwise would have gone to South Miami Hospital or one of the other nearby existing providers. Doctors' Hospital is a 255-bed acute care hospital located in Coral Gables, Dade County, Florida. Doctors' has had a cardiac catheterization program since December of 1986, and is authorized to perform diagnostic catheterization on both inpatients and outpatients. With its current staffing compliment, the Doctors' cardiac catheterization laboratory could comfortably perform four catheterizations per day or between 800 and 900 per year. Doctors' performs cardiac catheterization on all patients regardless of ability to pay. Since 1988, the Doctors' cardiac catheterization laboratory has experienced declining utilization. The following chart represents the utilization of Doctors' cardiac catheterization laboratory since 1988: TOTAL INPATIENT AND CALENDAR YEAR OUTPATIENT CARDIAC CATHS 1988 484 1989 400 1990 380 1991 295 1992 240 (estimated) The Doctors' inpatient cardiac catheterization program is at a crossroads. The current volume is well below the minimum quality threshold which is acceptable for cardiac catheterization laboratories. In its early years of operation, the Doctors' cardiac catheterization laboratory generated a profit. Such is no longer the case. Several factors have resulted in the declining utilization of Doctors' cardiac catheterization laboratory. One of the factors is that more of the existing laboratories have become open staff versus closed staff. Doctors' laboratory has always had an open staff policy. At the time that Doctors' established its cardiac catheterization laboratory, it was one of only two that had an open staff policy. Another factor in the decline of utilization at Doctors' has been a shift from inpatient to outpatient cardiac catheterization. Therefore, the opening of outpatient-only cardiac catheterization laboratories, including the one at Deering, has resulted in a reduction in the number of outpatient cardiac catheterization procedures done at Doctors'. Doctors' does not offer angioplasty or open heart surgery. Doctors' diagnostic-only cardiac catheterization capability has contributed to its declining utilization since Doctors' is unable to compete with full service hospitals for cardiac catheterization patients that require the services of a full service hospital. Another factor which has resulted in the decline in utilization at the Doctors' cardiac catheterization laboratory is a change in HMO service patterns to facilities that can provide full-service cardiology services, including cardiac catheterization, angioplasty, and open heart surgery. The primary reason Doctors' Hospital catheterization laboratory is now losing money is its decrease in utilization. As utilization of a cardiac catheterization laboratory declines, the per unit cost of providing a catheterization increases. Based upon the current market share of inpatient cardiac catheterization patients in District 11, and assuming Deering would be able to achieve its projected year two utilization of 360 new inpatient cardiac catheterization patients, a small number of those patients probably would have otherwise gone to Doctors' Hospital. Because of the declining utilization at the Doctors' cardiac catheterization laboratory, and the fact that its program is not co-located with open heart surgery, the loss of even a small number of patients may be significant to the future viability of the cardiac catheterization program at Doctors' Hospital. If the Deering inpatient program were to be approved, both the Deering and Doctors' programs would likely be low volume programs operating at utilization levels well below the minimum for maintaining quality standards and well below the minimum for economic efficiency. There are 13 providers of inpatient cardiac catheterization services in Dade County which operate a total of 24 catheterization laboratories. These providers are geographically well dispersed in the population centers of the county. The existing inpatient cardiac catheterization providers in District 11 are available, provide high quality care, are appropriate, and are accessible. In District 11 there is an ample excess capacity to provide additional inpatient cardiac catheterizations at existing facilities. The existing catheterization laboratories are not producing sufficient numbers of cases to be operating efficiently. The practical capacity of a typical catheterization laboratory is somewhere between 1,000 and 1,500 cases per year. Given that there are 24 existing catheterization laboratories and four more expected to come on line soon, the existing providers are operating at approximately half of their capacity. These programs have not reached a level of optimal efficiency in terms of operations. Optimal efficiency for health planning purposes should be measured at a level of approximately 80 or 85 percent of capacity. The economic efficiency of the existing providers of inpatient cardiac catheterization would be enhanced if new entries into the market were precluded until existing providers were operating at approximately 80 or 85 percent of their practical capacity. It is well accepted in health planning that a catheterization laboratory must perform at least 300 cases per year in order to maintain proficiency and quality. There appears to be a relative correlation between the number of cases performed in a laboratory and the skill of the staff. In District 11, HMO's and PPO's have shifted their service patterns to facilities that can provide full cardiac services including angioplasty and open heart surgery. The shift in use patterns has had a significant effect on cardiac catheterization laboratories unable to provide angioplasty and open heart surgery. This effect would likely be felt at Deering Hospital if its inpatient lab were approved and supports the conclusion that Deering, as a provider of diagnostic catheterizations only, would be unlikely to achieve its utilization projections. Cardiac catheterization services are highly competitive in District As such, the approval of Deering's application will have little beneficial improvement by way of increased competition. Additionally, the trend in District 11 is for third party payers to contract for the provision of cardiac services at full service providers. As such, Deering would be unable to effectively compete with the nine full service providers of which three, Baptist, South Miami, and Kendall, are in Deering's primary service area. There is no evidence that any patient has had, or is likely to have, problems accessing inpatient catheterization services if this proposal is not approved. The geographic access standard contained in the applicable rule is met by the existing providers. Additionally, none of the programs or doctors have been unable to schedule catheterizations because of heavy utilization at any District 11 catheterization provider. Accordingly, patients are not likely to experience any difficulty in accessing inpatient cardiac catheterization services if Deering's application is denied. Currently and historically, cardiac catheterization has been regulated by HRS as an inpatient institutional health service, not a tertiary service. On February 8, 1991, HRS published official notice of the need for one more inpatient cardiac catheterization program in District 11 for the 1993 planning horizon, calculated in accordance with the methodology in the applicable rule. The fixed need pool in this case was never challenged by Petitioners. The projected number of procedures by population in the planning horizon using the methodology in Joint Exhibit 1 and actual data collected by HRS show that there are enough procedures in the marketplace for Deering to perform 300 in the second year of operation and for the protestants in this case to maintain their annual current volumes. However, major portions of that rule- based methodology have been found to be invalid in the Final Order issued this same day in the related rule challenge cases.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be issued in this case denying the subject certificate of need application. DONE AND ENTERED this 1st day of April, 1994, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 1st day of April, 1994.
The Issue The issue for determination is whether Respondent’s rule is an invalid exercise of delegated legislative authority, and/or whether Respondent’s agency statement constitutes a rule and has not been adopted pursuant to the statutory rulemaking procedure.
Findings Of Fact Several children attending schools in the Broward County School Board’s (Respondent’s) district require the performing of medical procedures, among them daily catheterization, also referred to as intermittent urinary catheterization or clean intermittent catheterization, using the clean technique. 2/ Respondent ensures that such medical needs of each student are met. Catheterization (clean intermittent catheterization) is an invasive medical procedure. An invasive medical procedure is a medical procedure that invades or goes within a body orifice or opening for the purpose of providing care for the infirm, the promotion of wellness, maintenance of health, and/or prevention of illness. Catheterization involves the insertion of a tube into a student’s bladder through the urethral opening for the purpose of eliminating urine from the student’s body. Respondent's teacher aides and teacher assistants are paraprofessionals. They are primarily designated to specifically meet the needs of those students who require daily catheterization. For more than 15 years, Respondent has continuously engaged in a practice of using paraprofessionals to provide health-related services, including catheterization. Such practice by Respondent is a policy of Respondent. Respondent’s principals assign paraprofessionals to catheterize students, who have a disability or infirmity, and cannot deviate from this practice without the approval from the Area Superintendent. Principals are permitted to use licensed nursing personnel to catheterize students only when the principals receive approval from the Area Superintendent. Respondent has a standard procedure, even though there are no written guidelines, for servicing students who need catheterization because of disability or infirmity. The standard procedure is compulsory and each principal must adhere to it. The following process comprises this standard procedure: The medical situation of the student with a disability or infirmity must be reviewed by an Individual Educational Plan (IEP) committee. The IEP committee determines what services the student needs. If the IEP committee determines that a student requires catheterization, the principal selects a paraprofessional from the school’s staff and assigns that paraprofessional to perform the catheterization. If no paraprofessional is available, the principal declares a vacancy and advertises the vacancy. Until a paraprofessional is hired to fill the position, the School Board contracts with an outside agency to have a licensed nurse provide the service. In advertising for the paraprofessional vacancy, the principal specifies on the job listing that the applicant must be willing to accept the responsibility to provide individual care for the student, including daily catheterization. The applicant’s willingness to catheterize the student is a condition of hiring and of continued employment. When the paraprofessional is identified, the paraprofessional is given child-specific training. The training usually takes approximately two hours and is required to catheterize a student without direct supervision. (The training is provided primarily to show the individual paraprofessional the proper technique based on the child’s specific condition.) Cassandra Bennett (Petitioner Bennett) is a teacher aide employed by Respondent at Thurgood Marshall Elementary School (Thurgood Marshall). Broward Paraprofessional Association (PPA) is the certified bargaining representative for teacher aides employed by Respondent. Petitioner Bennett is a member of the PPA. Petitioner Bennett received child-specific training. The principal at Thurgood Marshall assigned duties to Petitioner Bennett, which included, but were not limited to, catheterizing a student at Thurgood Marshall. Petitioner Bennett did not feel comfortable catheterizing the student because she believed that catheterization was a medical procedure which required a licensed individual, which she was not. Petitioner Bennett notified her principal of her position. Regardless, the principal at Thurgood Marshall required Petitioner Bennett to catheterize the student. Petitioner Bennett complied with the principal’s directive because Petitioner Bennett believed that a refusal to perform the catheterization would result in the loss of her job. Respondent assured PPA that no paraprofessional would be forced to perform catheterization on a student. Moreover, Respondent assured PPA that, if a paraprofessional refused to attend training or to perform a catheterization, no disciplinary action would be taken against the paraprofessional. After being contacted by the PPA regarding Petitioner Bennett’s situation, Respondent notified the principal at Thurgood Marshall, by memorandum dated October 23, 1997, that no paraprofessional, including Petitioner Bennett, could be forced or required to perform catheterizations, but that paraprofessionals could only volunteer to perform catheterizations. Thereafter, Petitioner Bennett was notified that she was not required, and would no longer be required, to perform catheterization. Respondent employs a Clinical Nursing Supervisor, Marcia Bynoe, who is responsible for the paraprofessional training program. She has been a practicing nurse for over 20 years and has been a nursing school instructor. Ms. Bynoe is unaware of any other situation, besides the case at hand, wherein non-medical professionals are given catheterization training with the expectation that they will perform the medical procedure in the course of their employment. Paraprofessionals were and are utilized by Respondent for the catheterization of a student with a physical disability or infirmity as follows: To administer the treatment to the student to maintain the student’s health as directed by the School Board’s [Respondent’s] principal at Thurgood Marshall Elementary School, with the approval of Ms. Bynoe, and the School Board’s [Respondent’s] Coordinator of Health Education Services (who is also a registered nurse). To observe and evaluate the student’s physical condition, behaviors, signs and symptoms of illness associated with the catheterization and reactions to the treatment; and to make a determination as to whether such conditions, behaviors, signs, symptoms and reactions represent a deviation from what is considered normal. Paraprofessionals were trained and [Petitioner] Bennett was instructed to observe the student, measure the quantity of urine, and to look for signs of cloudiness, blood, mucus, strong or unusual odor, or other signs of trauma or infection. The paraprofessionals administer the treatment, including catheterization, with the approval of Respondent’s nurse. Periodic monitoring of the treatment being provided to the disabled students is conducted by Respondent’s nurse. Catheters that are used to catheterize the students are reusable. The catheters must, therefore, be washed and put away after each use in accordance with the training provided by Respondent. Paraprofessionals come in contact with body fluids due to catheterizing a student on a daily basis. Failure of a paraprofessional, because of lack of knowledge, training, or experience, to follow universal safety precautions or dispose of waste properly in performing the catheterization of a student who may have a contagious or infectious disease, can cause a life- threatening risk of contamination to other staff members, other students, the paraprofessional’s family, and the general public at large. Respondent is not aware of any other setting where unlicensed persons, other than the patient’s family members or the patients themselves, are trained to perform medical procedures like catheterization with the expectation that the unlicensed persons will be permitted to perform invasive medical procedures. Respondent’s non-medical personnel are not even permitted to give students injections. Some paraprofessionals are designated as surplus or excess and are placed on a surplus or excess list. Respondent’s representative who is responsible for the surplus or excess list of paraprofessionals requires these paraprofessionals to perform catheterization, if needed, in order to work. A list of vacancies is forwarded by Respondent to these paraprofessionals. The list of vacancies may contain positions which require a paraprofessional to perform catheterization. The excess paraprofessional must choose one of the listed positions, even a position that requires catheterization, or face termination. This requirement is contrary to Respondent’s pronounced position of not requiring paraprofessionals to perform catheterizations but making catheterization a voluntary act on the part of paraprofessionals. At some of Respondent’s school sites, paraprofessionals and other non-medical personnel are also being permitted or allowed to provide catheterization or supervise self- catheterization for students who have physical disabilities or infirmities. Paraprofessionals and the other non-medical personnel are monitored periodically by a nurse. Respondent has a policy, which includes its standard procedure, of utilizing paraprofessionals to catheterize students who have physical disabilities or infirmities. Respondent’s policy substantially affects its paraprofessionals, who are PPA members, at Respondent’s school sites attended by students, whose physical disability or infirmity requires catheterization. Respondent’s policy also substantially affects the special-needs children, themselves, and their parents. Chapter 232, Florida Statutes, is applicable to the case at hand. During the 1996 Legislative Session, the Florida Legislature passed an amendment to Chapter 232, by way of Committee Substitute for House Bill 483 (CS/HB 483), which became law without the governor’s signature and which took effect on July 1, 1996. The amendment is found at Chapter 96-294, Laws of Florida, and embodied in Florida Statutes at Section 232.465. The Final Bill Analysis for CS/HB 483 states, in pertinent part, as follows: SUMMARY: * * * [The bill] also prohibits certain medical services by nonmedical school district personnel in order to ensure that such nonmedical school district personnel are properly trained in the administration of medication and that these personnel refrain from performing invasive procedures. Invasive procedures include, but are not limited to: cleaning intermittent catheterization; providing sterile catheterization; cleaning and maintaining a tracheostomy; providing gastrostomy tube feeding; monitoring blood glucose; and administering injectable medications. SUBSTANTIVE ANALYSIS: PRESENT SITUATION: * * * In many situations, teachers are administering medical procedures, and there is a feeling that this goes beyond their "scope of academics" [sic]. Many instances exist where there are special needs children, requiring such procedures as catheterization, gastrostomy tube feeding (inserting tubes for feeding into the stomach), and the injection of medications. EFFECT OF PROPOSED CHANGES: The bill requires school district nonmedical personnel who administer prescribed medication to be trained by medical personnel. It also requires review of cases in which medications are administered and prohibits nonmedical personnel from performing invasive medical services such as cleaning intermittent catheterization, providing sterile catheterization, cleaning and maintaining a tracheostomy; providing gastrostomy tube feeding; monitoring blood glucose; and administering injectable medications. * * * SECTION-BY-SECTION ANALYSIS: * * * Section 2. Creates s. 232.465, F.S., to indicate that nonmedical school district personnel shall not be permitted to perform invasive medical services, including, but not limited to, cleaning intermittent catheterization; providing sterile catheterization; cleaning and maintaining a tracheostomy; providing gastrostomy tube feeding; monitoring blood glucose; and administering injectable medications. Provides that each school board shall establish emergency procedures for life- threatening emergencies. Section 232.465, Florida Statutes (Supp. 1996), provides in pertinent part: Nonmedical school district personnel shall not be allowed to perform invasive medical services that require special medical knowledge, nursing judgment, and nursing assessment. The procedures include, but are not limited to: Sterile catheterization. Nasogastric tube feeding. Cleaning and maintaining a tracheostomy and deep suctioning of a tracheostomy. Nonmedical assistive personnel shall be allowed to perform health-related services upon successful completion of child-specific training by a registered nurse, a licensed practical nurse, a physician licensed pursuant to chapter 458 or chapter 459, or a physician assistant certified pursuant to chapter 458 or chapter 459. All procedures shall be monitored periodically by the nurse. Those procedures include, but are not limited to: Cleaning intermittent catheterization. Gastrostomy tube feeding. Monitoring blood glucose. Administering emergency injectable medication. For all other invasive medical services not listed in subsection (1) or subsection (2), a registered nurse, a licensed practical nurse, a physician licensed pursuant to chapter 458 or chapter 459, or a physician assistant certified pursuant to chapter 458 or chapter 459 shall determine if nonmedical school district personnel shall be allowed to perform such service. CS/HB 483 was amended at the committee level in the Florida House of Representatives, and subsections (1), (2), and (3) of Section 232.465, reflect that amendment. The Florida House of Representatives substituted CS/HB 483 for CS/SB 1114 which contained the same wording as the aforementioned amendment. The Senate Staff Analysis and Economic Impact Statement for CS/SB 1114 states in pertinent part: 3/ Summary: This bill requires district school boards to have certain qualified medical professionals train school-based personnel . . . Non- medical assistive personnel, who have successfully completed child-specific training by an RN or LPN, may perform certain health-related services (e.g., cleaning intermittent catheterization; gastrostomy tube-feeding; monitoring blood glucose; or administering emergency injectable medications). A RN must determine whether nonmedical school district personnel may do other invasive procedures. . . . . * * * This bill amends s. 232.46, Florida Statutes, and creates s. 232.465, Florida Statutes. * * * III. Effect of Proposed Changes: Nonmedical school district personnel are prohibited from performing invasive medical services (e.g., sterile catheterization, nasogastric tube-feeding, or cleaning and maintaining a tracheostomy) that require special knowledge or nursing judgement/assessment. Nonmedical assistive personnel, who have successfully completed child-specific training by an RN or LPN may perform health-related services, such as cleaning intermittent catheterization; gastrostomy tube-feeding; monitoring blood glucose; or administering emergency injectable medications. An RN must determine whether other invasive medical services may be done by nonmedical school district personnel. Each school board must establish procedures for life-threatening emergencies. The changes made by this bill protect the health, safety, and welfare of both public school students and school district personnel. The Senate Staff Analysis also contained the following statement on the last page: "This Senate staff analysis does not reflect the intent or official position of the bill’s sponsor or of the Florida Senate. 4/ Attached to the Senate Staff Analysis was a one-page document entitled "STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN COMMITTEE SUBSTITUTE FOR SB 1114," which states in pertinent part the following: 5/ [P]rohibits nonmedical school district personnel from performing certain invasive medical procedures that require medical or nursing knowledge. Allows nonmedical assistive personnel to perform health-related services upon successfully completing child-specific training by an RN and with periodic monitoring by the nurse. Requires an RN to determine whether nonmedical school district personnel may perform other invasive medical services. It is clear that the staff analysis for CS/HB 483 is inaccurate, regarding the prohibition of non-medical personnel from performing invasive techniques upon completing child- specific training by a nurse, with periodic monitoring by the nurse, and the nurse approving non-medical personnel performing other invasive techniques. The staff analysis failed to reflect that there was no prohibition under the conditions aforementioned. Catheterization performed by the paraprofessionals requires some degree of special medical knowledge, nursing judgment, and nursing assessment. However, the catheterization is permitted by Section 232.465, Florida Statutes (Supp. 1996). Respondent has not engaged in rulemaking regarding the implementation of Subsection 232.465(2), Florida Statutes (Supp. 1996).
The Issue The main issue in these proceedings is whether the Respondent Doctors is entitled to a certificate of need to establish a cardiac catheterization laboratory in Sarasota County. The parties stipulate that the only statutory and rule criteria which remain to be reviewed by the Hearing Officer areas follows: 1. Sections 381.705(1)(a) , (b) , (c) , (d) , , and (h), Florida Statutes. Section 38l.705(1)(h)) will be reviewed insofar as it refers to the availability of health manpower, management personnel, funds for capital and operating expenditures, the alternative uses of the applicant's resources, and the extent to which the proposed services will be accessible to all residents of the district. Section 38l.705(1)(1) and (n), Florida Statutes. Section 381.705(2)(a) , (b) and () Florida Statutes. Rule 10-5.011(1)(e), Florida Administrative Code. 5. Rule 10-5.011 (8)b and (8)0, (9)b, (9)d, (9) e (1) and (9)e(ll) The other statutory criteria and the remaining subsections of the rule have either been stipulated to by the parties or are inapplicable.
Findings Of Fact Respondent Doctors is a 168 bed, acute care general hospital. The hospital has a 40 bed cardiac care unit in which all beds are monitored. Hospital Corporation of America (HCA) owns Doctors. HCA owns or operates four hundred hospitals, including nineteen in Florida. Three of the in-state hospitals have cardiac catheterization laboratories (CCLs) . Two of the existing labs, located in Bradenton and Tallahassee, are available to assist in training and preparation which may be needed in the creation of a cardiac catheterization lab at Doctors. In September 1987, Doctors applied for Certificate of Need No. 5283 to establish a cardiac catheterization laboratory. The certificate of need has been preliminarily approved by the Respondent HRS. The initial agency action has been challenged by the Petitioner, Memorial. Memorial is the primary existing health care facility which would compete with Doctors by providing cardiac catheterization services in the same city where the new lab is to be located. Consistency with State and Local Health Plans The local health plan does not directly address the need for CCLs in the area. As nothing in the plan is relevant, no inconsistencies are created with the plan in the balancing of criteria with regard to the certificate of need determination. The State Health Plan provides that an average of 600 cardiac catheterization procedures per laboratory are to be maintained in each district through 1990. To determine the use rate under Rule 10-5.011, Florida Administrative Code, HRS must look to the number of procedures provided in the district between June 1984 and July 1986. The data reveals that seven programs completed 5,841 procedures. The required averages were exceeded by over two hundred procedures per lab. The need criteria has been met by Doctors for purposes of the State Health Plan, and the local plan, as it existed at the time of the initial review of the application. Existing Facilities Memorial is an 849 bed, acute care hospital which is a regional referral hospital in the area. The hospital provides Level 3 cardiac services. These services include angioplasty and open heart surgery in addition to cardiac catheterization. Memorial's first catheterization lab opened in 1978. Memorial currently contains two CCLs that assist in fulfilling the health care needs of the district. Before the recent addition of three CCLs within the district, Memorial served as the center for cardiac services. Manatee County and Charlotte County now have their own CCLs, which reduces Memorial's pool of potential patients in need of those services. In spite of reductions in the patient pool in the past, Memorial's use of its two CCLs has continued to grow. The Sarasota County area has a unique characteristic in that many tourists who arrive in the winter months (October-April) make use of the two local hospitals, Doctors and Memorial. The use of Memorial's CCLs increases as the local cardiologists need to complete a number of diagnostic tests in order to evaluate these new patients quickly, in times of critical need. Because of the season, Memorial's CCLs are heavily utilized for emergency procedures in the winter months. Accordingly, patients who have elective procedures scheduled are often reprioritized because of the emergency needs for use of the CCLs for more seriously ill patients. This last-minute rescheduling results in prolonged hospitalizations for the nonemergency patients and increases the cost of their medical care. Although the quality of testing does not appear to suffer from the season, a significant pool of patients is denied the opportunity for convenient medical care. The treating physicians are denied lab use and test results at the anticipated times within these patients' courses of treatment. Because of Memorial's inability to make the labs readily accessible to the pool of patients scheduled for elective procedures in the winter, a need exists for a CCL for this pool of patients. Doctors primarily seeks to provide cardiac catheterization services for diagnostic purposes. However, the lab will be capable of providing immediate endocardiac catheterization pacemaking in cases of cardiac arrest. A rapid mobilization team will be available for emergency procedures when the need arises. Angioplasty and open heart surgery procedures are not planned in conjunction with the CCL services. The lab will be in operation from 7:30 a.m. to 4:00 p.m. Monday through Friday, excluding holidays. Quality of Care Doctors currently provides quality care. There are no complaints outstanding, and the hospital has sufficient capabilities and support services to provide for a CCL. Doctors is JCAH accredited and provides the necessary services required under the catheterization rule. The same cardiologists are on staff of both Memorial and Doctors. Most of these physicians admit patients to both hospitals. Approximately one-third of Doctors' admissions are patients with cardiac problems. Many of these patients require catheterization and are transferred to Memorial. If it is determined that a catheterization is needed before admission, physicians admit those patients to Memorial. Alternative Care The other CCL which currently exists in Sarasota is an outpatient lab. This facility is owned and operated by a group of invasive cardiologists who also perform catheterizations at Memorial. Because the outpatient lab restricts a patient's selection of a physician able to perform a cardiac catheterization to the lab owners, this lab is not a realistic alternative for most patients or the referring physicians. A hospital-based lab gives those involved greater personal choice, and it is better equipped to handle unanticipated emergencies. Reasonable and Economic Accessibility Memorial's CCL services are not always accessible at the times scheduled for elective procedures. Some patients have remained hospitalized for days until they can be rescheduled. The delays increase the costs attached to the procedures due to the length of the hospital stay and the additional services required. Patients admitted to Doctors who require the services of a CCL are moved to Memorial by ambulance and have to be admitted there. These transfers cost patients an additional $180-$340. The ambulance charges are not reimbursed by medicare so the majority of the patients pay these charges themselves. The proposed lab will be capable of providing a range of diagnostic tests without the need to admit patients to another hospital prior to, or during treatment at, Doctors. This will reduce costs two ways: The additional ambulance and hospital costs will be omitted, and the proposed charge for the service is less than the current charge set by Memorial. Availability of Resources Doctors currently has a staff of trained cardiac nurses. There are two nurses on staff who have taught cardiac catheterization techniques at an accredited nursing school prior to moving to Sarasota. Although the husband and wife team was originally recruited to the area by Memorial, the two nurses chose to leave that facility because of the stress from the high level of activity in those labs. Doctors plans to cross train staff and to allow for a trained special procedures staff with alternating roles and duties. The proposed CCL will be staffed with 2.5 FTEs. These consist of the 1 FTE cardiac nurse and 1.5 FTE special procedures technicians. The budgeted FTEs do not include an allocation of time for an administrative director or secretarial/clerical services. The assistant hospital administrator anticipates that provisions will be made for management personnel at a later stage of the lab's development. Although the number of FTEs scheduled is less than those anticipated for a CCL which provides more complex procedures, the number scheduled by Doctors is reasonable for the number of services and kind of services it seeks to provide for the type of cardiac patients in its care. The proposal for the lab, as described in the application and revised in the omissions response, is financially feasible. The proposed expenditure of funds will serve the needs of the hospital's current patient pool as well as the special needs of the community for cardiac catheterization services. While Doctors' proposal does not increase geographic access, it will increase access in the population center, where services are currently inaccessible for one pool of patients at certain times. A need for a project is evidenced by the utilization of like and existing services. The rule which contains the need methodology takes into account the utilization of existing facilities in determination of numeric need. Numeric needs exists in this district, pursuant to Rule 10-5.011. Written Referral Agreement Doctors submitted a written referral agreement with a facility with open heart surgery services within 30 minutes travel time by emergency vehicle under average travel conditions. The agreement meets the general requirements of HRS. The agency does not require a detailed agreement during the preliminary granting of a certificate of need because other local providers do not wish to assist applicants during the CON process. However, such applicants are able to obtain more detailed agreements after the certificate is approved. The agency has determined that the agreement is sufficient. Because a rational basis has been given for the determination, the agency's acceptance of the agreement is given great weight by the Hearing Officer. Competition and Service Doctors' project will affect competition between Doctors and Memorial. Doctors will provide services for patients who would have gone to Memorial for such services in the past because Doctors was unable to provide the service. This is because of the geographic location and the fact that the same cardiologists are on staff at both hospitals. It appears that Doctors will be providing services for patients who are not in critical need of the services. This will allow Memorial to concentrate on the more complex cases has traditionally dealt with in the past. The stress from "unhappy" elective patients will be reduced at Memorial's labs, but so will the economic incentive for the staff which is related to the number of procedures performed. The elective cardiac catheterizations are quicker and easier to perform and increase the earnings of the lab staff. Both hospitals compete directly for staff. There is a "revolving- door" situation in staffing as local heath care personnel negotiates and works in either hospital, most of the time. Because of cash bonuses offered by Doctors for joining its staff Memorial is concerned about the adverse impact upon its CCL staff. Testimony presented at hearing showed by substantial and competent evidence that Memorial is committed to equipping its two labs with the most responsive equipment available for its more complex needs. The preservation of its current lab staff has been planned for by an able administrator. Recruitment is done nationwide and plans are being made with the local community college to provide nurses training involving cardiac catheterizations. The evidence also demonstrated that Memorial plans to meet the competition by improving the health services delivery, quality assurance, and cost-effectiveness. It appears that there is room for all three labs in Sarasota, and that healthy competition will occur in the area. Past and Proposed Indigent care Doctors has given little care to the medically indigent in the past. In fact, the hospital has maintained a written policy suggesting that those who cannot pay for services should be transferred by physicians to another hospital. Rather than admit such patients, the Doctors has chosen to pay into an indigent care fund. The new assistant director maintains that the current hospital policy is to provide health care to Medicaid and indigent patients in the CCL. Doctors projects that 2.5 per cent of its catheterization volume will be Medicaid and .75 per cent will be indigent care. Alternatives to the Project The alternative which has been developed and studied by Doctors is its past use of Memorial's CCLs. This use has been found to be more costly for elective cardiac catheterizations than the current proposal. The status quo has not met the needs of the elective catheterization patients in the geographical area. Similar Inpatient Services Memorial is using its similar facilities in an efficient manner. It is not using the facilities in an appropriate manner as most elective catheterization patients do not want to be in a hospital any longer than necessary. These people are predominantly type A personalities who do not like being rescheduled and charged additional hospital costs. Problems in Outpatient Inpatient Care Elective catheterization patients have a problem obtaining local inpatient care when they want it and when their cardiologists have prepared for it in their treatment plans. This does not appear to be a serious health problem, but the evidence has demonstrated it is a serious problem. Proposed Volume of Catheterizations Based upon numeric need, utilization of Memorial, physician support, and the growth history of other providers within the district, the projected utilization of 246 procedures in 1990, 294 in 1991, and 351 in 1992 is reasonable. There is no evidence which has been extrapolated from reliable data which shows that the proposed lab, coupled with alternative treatments and currently available noninvasive technological advancements, will reduce the average number of procedures per lab within the district below 600 each year. Due to the population growth projections for Sarasota County, approval of Doctors' application will have minimal impact on lab utilization at Memorial or other facilities within the district. Doctors' projected number of procedures will not decrease procedures at Memorial below its 1987 level of 2,495 cardiac catheterization procedures performed on an annual basis.
The Issue The issue in this case is whether Jose Rosado, M.D., (Respondent), violated Section 458.331(1)(t), and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Florida law. At all times material to these proceedings, Respondent has been a licensed physician in the State of Florida, having been issued license number ME 0068035. Respondent is board-certified in internal medicine and cardiovascular diseases. On March 10, 1997, Patient W.B.C., a 72-year-old man, arrived at the Leesburg Regional Medical Center (LRMC) emergency room. He complained of a sudden onset of weakness in his left hand and arm with numbness and tingling. Respondent was Patient W.B.C.'s primary care physician. Respondent admitted Patient W.B.C. with a diagnosis of cerebrovascular accident, mitral regurgitation, sick sinus syndrome and a history of myocardial infarction. Respondent ordered that Patient W.B.C. undergo a head CT scan, carotid Doppler, 2-D echocardiogram, an electroencephalogram, and a neurological consultation. Based on the test results and the consultation, Respondent diagnosed Patient W.B.C. with right cerebrovascular accident, mitral regurgitation, sick sinus syndrome, and history of myocardial infarction. Respondent then discharged the patient with Ticlid, a medication to prevent further cerebrovascular accidents and aspirin. On March 16, 1997, Patient W.B.C. was admitted to LRMC complaining of weakness, dizziness and a fever. His vital signs revealed a temperature of 103.0 F, a pulse of 118, and a blood pressure of 139/75. The emergency room physician ordered a chest x-ray, EKG, and urine and blood cultures. The chest x-ray revealed no acute cardiopulmonary abnormality. Urine tests revealed features consistent with the possibility of urosepsis. Blood work showed a white blood count of 9.15, elevated but within the normal range. Also on March 16, Respondent ordered that antibiotics be given prophylactically until the blood cultures came back from the laboratory. The cultures came back positive for staphylococcus aureus (staph). Staph is a notoriously “bad bug” and Staphylococci aureus bacteremia has a high mortality rate. Staph aureus can originate from several possible sources including infections through the urinary tract system, IV sites, aspiration into the lungs, and pneumonia (although not very common). Staphylococci in the bloodstream is known as bacteremia. Bacteremia can lead to endocarditis which is an infection of the inner lining of the heart and the heart valves. Endocarditis is a life-threatening condition that can quickly damage the heart valves and lead to heart failure or even death. Patients with certain cardiac conditions such as mitral valve regurgitation have a higher risk of developing endocarditis. Patient W.B.C. had such a history. On March 17, 1997, Patient W.B.C. was started on intravenous antibiotics by Respondent. Patient W.B.C. continued to receive the intravenous antibiotics for four days from March 17, 1997, through March 20, 1997. Respondent then switched Patient W.B.C. to oral antibiotics and kept the patient in the hospital one more day prior to discharging him with instruction to continue on the oral antibiotics for another ten days. Patient W.B.C. was discharged on March 21, 1997. He was not referred to an infectious disease specialist nor had Respondent obtained a consultation with any specialist to determine the length of time that the patient's infection should be treated. Respondent felt that he was adequately qualified to treat this patient, and the treatment appeared to work. Respondent thought the bacteria growing in the patient's blood "likely" originated from a lung infection. An infectious disease specialist should have been consulted to give guidance as to how long to treat the infection. The standard of care for treating a staph aureus infection where there is a known source of infection requires 14 days of intravenous antibiotics. Where the source is not known, then four to six weeks of antibiotics is recommended. In this case, the infection, a resistant staph infection found in the patient's blood, could have originated from several sources. While such staph could have sprung from a source in the lung, this is by no means likely and the infection could have originated from another source. The standard of care required that Respondent contact an infectious disease specialist for an evaluation and/or that he treat Patient W.B.C.’s staphylococcus with a minimum of 10 to days of intravenous antibiotics. On or about April 11, 1997, Patient W.B.C., presented to the emergency room at LRMC complaining of congestion, shortness of breath, fever of 100.3° F, and a cough. The emergency room physician performed a physical exam which revealed vital signs of a temperature of 101.3° F, a pulse of 104, and a blood pressure of 90/54. A chest x-ray, blood work and a urine culture were ordered. Patient W.B.C. was then admitted on April 11, 1997, with a diagnosis of pneumonia, an old cerebrovascular accident and coronary artery disease. The ER physician started Patient W.B.C. on a plan of treatment which included intravenous antibiotics, Vancomycin, IV fluids, and blood cultures. A physical examination on the patient revealed a temperature of 101.3° F, a pulse of 104 and blood pressure of 91/53. The attending physician diagnosed him with probable sepsis with pneumonia. On April 12, 1997, the blood cultures came back positive for Staphylococcus aureus bacteremia. On April 15, 1997, Patient W.B.C. was afebrile (without fever) and his white blood cell count was 10.23, which is within the normal range of 4.0 to 11.0. The patient continued in this condition through April 18, 1997, despite suffering from sepsis. On April 18, 1997, Respondent approved Patient W.B.C. for transfer to another institution for consideration for urgent mitral valve replacement. On April 19, 1997, Patient W.B.C. arrested and was pronounced dead at 5:53 a.m. Petitioner’s expert, Carlos Sotolongo, M.D., is board- certified in internal medicine, cardiovascular disease and nuclear cardiology. As established by Dr. Sotolongo's testimony, Respondent practiced below the standard of care by failing to treat Patient W.B.C. with a sufficient number of days of intravenous antibiotics and by failing to consult an infectious disease specialist. According to Dr. Sotolongo, there is a difference in the way that an uncomplicated pneumonia is treated as opposed to a pneumonia complicated by bacteremia. The latter must be treated more aggressively. Based on the foregoing, Respondent violated Section 458.331(1)(t), by failing to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing, it is recommended that a Final Order be entered finding that Respondent violated Section 458.331(1)(t), and imposing a penalty which includes a formal reprimand, payment of an Administrative Fine in the amount of $5,000.00 within 180 days, and eight hours of Continuing Medical Education (CME) to be completed within the next 12 months dealing with the diagnosis and treatment of infections and/or risk management. DONE AND ENTERED this 1st day of October, 2003, in Tallahassee, Leon County, Florida. S DON W. DAVIS 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 1st day of October, 2003. COPIES FURNISHED: William M. Furlow, Esquire Katz, Kutter, Alderman, Bryant & Yon, P.A. Post Office Box 1877 Tallahassee, Florida 32302-1877 Kim M. Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Procedural issues. In June 1983, Petitioner filed an application for a certificate of need to operate a cardiac catheterization laboratory at Hollywood Medical Center. Respondent, the Department of Health and Rehabilitative Service (HRS) denied the application, and Petitioner filed this petition for administrative review. Notice of hearing was given by order dated August 6, 1984. Two days before the hearing, SOUTH BROWARD HOSPITAL DISTRICT moved to intervene. The petition was denied because it was filed less than five days before the hearing, and was therefore untimely. Rule 28-5.207, F.A.C. Also shortly before the hearing, HRS filed a motion in limine, seeking to exclude evidence of cardiac catheterization utilization other than a base year of 1981. The motion was denied because the relevant rule, rule 10-5.11(15) allows proof of "not normal" circumstances. Prior to the hearing, the parties filed a joint prehearing stipulation, agreeing to certain issues of law and fact. Pursuant to that stipulation, the following criteria are either not applicable in this case or have been satisfied by the Petitioner: section 381.494(6)(c)(3), (4), (5), (6), (7), (8), (10), (11), and (13), Fla. Stat., section 381.494(6)(d), Fla. Stat., and rule 10-5.11(15)(a) through (f), (g), (h)(1) and (2), (i)(1) through (3) and (5), (j), (m), (n), and (o)(2). It was further stipulated that the Petitioner will not be performing coronary angioplasty in its proposed cardiac catheterization laboratory. HRS further stipulated that if the Petitioner satisfies all other applicable criteria, the project will be financially feasible. Remaining at issue in this case are subparagraphs (6)(c)(1), (2), and (12) of section 381.494, Fla. Stat., and subparagraphs (h)(3), (i)(4), (k)(1), and (o)(1) and (3) of rule 10-5.11(15). F.A.C. The central issue in this case is whether pursuant to the relevant statutory and rule criteria there is a need for a cardiac catheterization laboratory at Hollywood Medical Center. The Hollywood Medical Center is located in the southern portion of Broward County. It is a 334 licensed bed medical/surgical hospital, and its medical staff covers all major medical specialties. The hospital has 24 hour emergency service, 14 intensive care beds, a full service operating room, and does cardiovascular surgery, but does not do open heart or bypass surgery. Hollywood Medical Center, based on zip codes from its own patient records, serves patients primarily from the Dade County line a few miles south to the New River Canal on the north and from the ocean on the east to the Collier County line on the west. In this service area, physicians tend to be located in the eastern section, and do not typically have staff privileges at hospitals in northern Broward County, nor do they tend to refer patients to hospitals in the northern section of Broward County. Patients at Hollywood Medical Center who need cardiac catheterization procedures are now referred to Memorial Hospital, which is approximately 2 miles away. In the south Broward County area, there is no other alternative. There was no evidence of any cardiac catheterization facility in northern Dade County accessible to patients from southern Broward County with the exception of a newly granted certificate of need to Humana Biscayne. There was no evidence as to when Humana Biscayne will be open and providing services. In northern Broward County, there are five operating cardiac catheterization laboratories. The one closest to Hollywood Medical Center, Broward General Medical Center, is approximately 6 miles to the north. Rule 10-5.11(15)(1), F.A.C., establishes a method of projecting the number of cardiac catheterization procedures expected for the year in which the proposed new service would begin. This number is the product of the projected population for the service area and the number of procedures performed in 1981 in the service area for one hundred thousand population. HRS interprets this rule to require analysis based upon HRS district data. The HRS district in this case is district ten, which is Broward County. Once the projected number of procedures is determined, that number is divided by 600 to determine the number of catheterization laboratories needed. This number is derived from rule 10- 5.11(15)(o)3., which forbids approval of a new laboratory if the average volume for all laboratories in the service area drops below 600. HRS now argues that the number 600 is only a floor to protect existing providers, and is not to be used to compute need. In the normal computation of need under the rule, this is not true. Thomas Porter, supervisor of the certificate of need section at HRS calculated his Projections of need using 600 procedures per unit in the district as the means to determine the need for a new laboratory. Mr. Porter testified: "Well, in terms of what I would agree with is in terms of numerically determining the need for the number of labs, we divide by 600 procedures. . . . HRS based its denial of the certificate of need in this case by using a use rate for Broward County in 1981 of 329.5 procedures per one hundred thousand population. This use rate in turn was based upon a 1981 population of 1,046,646 and 3,449 procedures in the county for that year. Since the projected population for Broward County in 1986, two years from the date of the hearing, is 1,179,205, HRS concluded that by 1986 the county will need 6.475 laboratories, which rounds to 6. There are 5 licensed and operating laboratories now in Broward County, and 2 additional laboratories have been approved by HRS in the final order in PLANTATION GENERAL HOSPITAL v. HRS, et al., DOAH case number 84-1838, 6 FALR 6796 (1984). Using the method proposed by HRS to calculate need, there is no need for an additional laboratory as sought by Petitioner in this case. Petitioner's exhibit 4, table 5, computes the same formula set forth above, but uses a 1981 rate of 340 catheterization procedures per one hundred thousand. This rate is incorrect. On table 2 of this exhibit the actual procedures for each Broward County facility is recorded for 1981, and the total number of procedures has been incorrectly added. The correct total is 3,449, not 3,546, and the resultant rate (which is based upon a slightly lower estimate of 1981 population, 1,042,941) is 330.7 procedures per one hundred thousand. Correcting table 5 using the 330.7 rate, the need for cardiac catheterization laboratories is: YEAR DISTRICT 1985 6.3 1986 6.5 Thus, if the rule for determining need in a normal situation is followed, the record in this case shows no need for the catheterization facility proposed by the petitioner. Subpart 15(f) of the rule, however, allows approval of an application if the circumstances are other than normal, in which case approval can occur even though need is not shown by subpart 15(l) and 15(o), above, pertaining to calculation of need using the 1981 use rate, future population projections, and division by 600. Mr. Porter testified for HRS that the 1981 use rate has been a fairly accurate predictor of actual use rates in subsequent years, but that it has not yet been accurate in Broward County. In 1981 the use rate, as corrected above, was 329.5, accepting as true the HRS population estimate for Broward County in 1981. In 1982 the use rate was 393.6. This figure differs from Petitioner's exhibit 4, table 3, because the columns are incorrectly added on table 2. The correct total of procedures for 1982 is 4211. The correct total for 1983 is 5008. In 1983 the use rate was 457.9 using the 5008 figure. Thus, in two years, Broward County has increased its use of cardiac catheterization by 39 percent over the 1981 base rate. HRS argued that the 1981 planning rate should continue to be used because current data may be anomalous, and not reflective of the long range trend. This might be true if the base rate were reflective of a stable prior trend, but it is not. It is only the data from one year, and as such, is less persuasive as a predictor of the future. The trend for at least Broward County in the six years from 1977 is reflected in Petitioner's exhibit 4, table 3. In 1977, the use rate in Broward County was 174 procedures per one hundred thousand. The actual rate has increased steadily each year for six years to the rate indicated above for 1983, 457.9 per one hundred thousand. This is an increase from the 1977 rate of about 263 percent. At least in Broward County, this data indicates that the 1981 rate is probably not static, but is only a point on a trend that shows significant increases annually. There was partial evidence that the trend indicated above may be slowing down. Dr. Silvio Sperber, who is a cardiologist in charge of the cardiac catheterization laboratory at Memorial Hospital, testified that Memorial Hospital had had 673 cardiac catheterization procedures from January 1984 through September 1984. He testified that his laboratory was running about 15 percent fewer procedures than the year before. This was not accurate. From Petitioner's exhibit 4, table 2, Memorial Hospital experienced 942 procedures in 1983. By the end of September 1984, it should have experienced about 75 percent of that number at a zero rate of increase, or 706 procedures. Its actual experience in nine months, 673, is only 4.7 percent less than the 1983 expected number of 706.3. The Memorial Hospital experience in 1984 is some evidence that the rate of increase in Broward County may be less or even stabilize in the future at the 1983 utilization rate, but this is evidence from only one hospital. The other four operating laboratories may have experienced a similar decline, or an increase, but there is no evidence on the point. And in any event, Use small decline at Memorial does not persuasively indicate a return to the significantly lower 1981 Broward County rate. There was additional evidence to support the conclusion that the 1983 rate of use would not decline again to the 1981 rate. Atherosclerotic heart disease is the number one cause of death in the United States today. Cardiac catheterization is the best tool currently available for evaluation of the condition of the heart. From 1978 to 1982, Broward County has experienced a higher death rate for major cardiovascular disease than Florida as a whole. The death rate was 16.6 percent higher in Broward County in 1982 than in Florida generally. Additionally, cardiac catheterization seems to he coming more and more useful in the treatment of heart disease. Three years ago, when HRS established the 1981 base rate, catheterization was not considered a state-of- the-art procedure for treatment of an acute heart attack. Today, catheterization during the first few hours of a heart attack for the point injection of a clot dissolving substance, streptokinase, is proving to be a remarkably effective means of reducing the long-range damage of clot caused heart attacks. Further, use of catheterization during the attack itself has enabled physicians to see for the first time that most heart attacks are caused by clots. As good uses for catheterization increase, it is only reasonable to expect that the utilization rate will increase. While the foregoing is some evidence that application of subpart 15(l) and (o) of the rule in this case in Broward County produces a "not normal" result, justifying consideration of additional evidence of need, it still does not necessarily follow that the application herein should be granted. First, using the 1983 use rate of 457.9 procedures per one hundred thousand population, and the 1986 predicted population of 1,179,205 in Broward County, the number of expected procedures by 1986 is 5400. There will be 7 approved laboratories by 1986, and thus each would be able to perform approximately 771 procedures, if there is an even distribution within the county. This would be considerably less than approximate maximum capacity of a catheterization laboratory, which is somewhat less than 1300. Dr. Sperber testified that his laboratory could perform 5 procedures per day, 5 days a week, or 1300 per year. This, however, fails to account for emergency work and angioplasty, both of which take more than two hours. Angioplasty at Memorial now runs about 15 percent of all procedures. It is urged by petitioner that once the number of procedures is predicted for 1986, then the need for laboratories should be derived by dividing that number by 600, which is in subpart 15(o) of the rule. While this is the procedure for determining need in the normal case, as found above, it does not follow that the standard of 600 continues to apply to determine need in the abnormal case. The "not normal" exception of subpart 15(f) of the rule operates to except analysis of need not only from the 1981 use rate (subpart 15(l)), but also the 600 procedures standard (subpart 15(o)). Since the 600 standard is only about 50 percent of maximum capacity, it constitutes a rather low threshold number for commencement of a new laboratory. In effect, although the 1981 use rate apparently predicts only 72 percent of the need as compared to the 1983 rate, the 600 standard overpredicts need by at least the same amount. As indicated above, even if the 1983 use rate is used, the seven approved laboratories would be easily able to handle this need since the average spread among these laboratories would be about 771 procedures per laboratory. Though petitioner sought to show that there would be unmet need in the area actually served by Hollywood Medical Center, the evidence falls short of demonstrating a "not normal" situation of actual unmet need in that area justifying approval of its application. This evidence will be considered in the following findings. HRS does not consider district lines to be absolute if the facts justify consideration of services available in an adjacent district. In Broward County the local health council has debated the issue of dividing the district service area into subdistricts, but has not chosen to do so. Mr. Porter testified that he could think of as many reasons to divide the county as reasons not to divide the county. Broward County is divided north and south by the legislature into two hospital districts, however. As found above, physicians in the southern portion of Broward County tend to refer patients to hospitals in the same area, and do not use hospitals in northern Broward County. These physicians tend to use hospitals closer to their offices, and consequently do not usually have staff privileges at hospitals in the northern portion of the county. These patterns of use, however, have not been shown to be an immutable condition, but simply reflect current practices. Patients at Hollywood Medical Center who currently need cardiac catheterization are transferred to Memorial Hospital, a few miles away. Memorial Hospital is about a ten minute drive from Hollywood Medical Center. The cost of transfer is about 5300 to 5400. Although Hollywood Medical Center cardiac patients needing diagnostic catheterization at times must wait a day or two before Memorial can provide that service, such delays were not typically of major significance or life-threatening. A more significant problem experienced on occasion by Hollywood Medical Center has been inability to transfer unstable patients to Memorial for diagnostic catheterization. Acutely ill patients at times may need catheterization for diagnostic purposes, but are too ill to be transferred by ambulance to Memorial for the procedure. However, the record does not contain evidence of how frequently this occurs. In any event, these inconveniences are normal and expected where not every hospital has cardiac catheterization facilities. Stated another way, the above would be evidence of a "not normal" condition only if the normal condition was for all acute care hospitals to have catheterization laboratories, which is not the case. As discussed above, cardiac catheterization is also used for emergency treatment of heart attack by the injection of streptokinase directly to the clot causing the attack. Cardiac catheterization facilities must be available at the hospital initially receiving the heart attack patient because these patients are usually too unstable to be transferred from the emergency room of the receiving hospital to Memorial. Treatment by streptokinase injection is therapeutically most beneficial only in the first few hours of the heart attack, or at least within six hours of the emergency, because it is during this period that the permanent damage caused by the clot will occur. Dr. Stephen Roth, a cardiologist on the staff of Hollywood Medical Center, had from 5 to 10 heart attack patients in 1984 who needed streptokinase injection by catheterization, and who suffered a deterioration of their condition due to the unavailability of facilities for catheterization at Hollywood Medical Center. He implied that his two other partners had a similar experience, but the record does not contain competent evidence to support a finding as to the magnitude of the problem for them. Dr. Jeffrey Erlich, also a cardiologist, has had a similar problem of having heart attack patients arrive at Hollywood Medical Center in need of emergency streptokinase injection by catheterization, but did not testify as to the magnitude of the problem. In Dr. Erlich's opinion, every acute care hospital that treats heart attack victims should have a cardiac catheterization laboratory to provide emergency injection of streptokinase. Dr. Silvio Sperber, who is one of the only three physicians who run the cardiac catheterization facility at Memorial Hospital, testified that he had performed about 7 streptokinase injection procedures since the beginning of 1984. The foregoing is insufficient evidence of a "not normal" need for a cardiac catheterization laboratory at Hollywood Memorial Hospital. The number of emergencies are not that great, the problem is not atypical of other hospitals not having cardiac catheterization facilities, and there is no evidence of any failed efforts to have emergency vehicle operators take all heart attack patients directly to the available laboratories in the area. See paragraph 24, ahead. Administratively, the process of transferring a patient from Hollywood Medical Center to Memorial for cardiac catheterization causes the sort of problems normally associated with transfer of ill patients. Though the drive is only ten minutes, the time preparing the patient and actually transferring the patient is much longer, and is a hardship on the patient. However, almost all of the cardiologists at Hollywood Medical Center are on the staff of Memorial, and can follow their patients at that facility without much difficulty, since it is only ten minutes away. In 1983, Memorial Hospital had 942 catheterization procedures. If the 1984 experience continues at 4.7 percent less than 1983, Memorial Hospital will perform about 898 procedures. If thereafter it experiences only a 10 percent growth rate, Memorial Hospital will perform 1086 procedures in 1986, and 1195 procedures in 1987. It is reasonable to conclude that it will reach its maximum capacity in a few years, probably by 1988. However, although not currently used by Hollywood Medical Center, there are or will be two catheterization facilities within less than eight miles. Broward General Hospital is the next closest, apparently about six miles away. In 1983, Broward General performed only 551 procedures, indicating significant future capacity. Additionally, a new laboratory has been approved for Plantation General Hospital, about eight miles away. Since this laboratory will be new, it will have a long way to go before it reaches a 1200 capacity. The driving distance to these two other facilities may be a few miles more than this, but the distance is not significantly greater than Memorial. Although Petitioner's physicians testified that they did not consider the hospitals further north to be acceptable as alternatives to Memorial, the distance alone does not pose a significant problem. The major problem is not in the driving distance, as long as the trip is 10 or 20 minutes driving time, but the administrative preparation time at either end, which would be the same inconvenience for transportation regardless which alternative was used. Typically patients who suffer a heart attack are transported to the emergency rooms of any number of hospitals in Broward County. Dr. Erlich testified that his prior patients do not usually call him before arriving at a hospital, and that he has no ability to direct his patients to a hospital having cardiac catheterization capability. Thus, he felt that all such hospitals should have the capability. There is no evidence that Memorial Hospital could not handle more heart attack patients, or that emergency vehicle operators could not transport more heart attack patients to Memorial. An ambulance carrying a heart attack patient could just as easily arrive at the emergency room of Memorial than it could at Hollywood Medical Center, only ten minutes away. The problem of having heart attack patients arrive in an unstable condition at Hollywood, where there is no catheterization facility, ought to be solved at least in part by greater coordination with emergency vehicle operators in the vicinity of the two hospitals. Dr. Sperber and his two partners apparently have a monopoly over the performance of cardiac catheterization procedures at Memorial Hospital. This factor is somewhat relevant to the issue of need for the proposed new catheterization laboratory, but absent additional evidence that patients will in fact be denied the service, or will receive service of poor quality or at unreasonable expense due to this apparent monopoly, this one factor alone does not show sufficient need to warrant approval of the application. Some patients prefer to go to Hollywood Medical Center, which is a smaller, for-profit hospital, but patient preference of this sort does not show a "not normal" need for the proposed catheterization laboratory. Based upon all of the foregoing, there is not sufficient evidence on this record demonstrating a "not normal" condition of need by 1986 to justify granting this application. However, if there were a need shown by the evidence, the following additional findings are made. Thomas Porter testified for HRS that the requirement that there be adequate care for indigents is satisfied if such care is provided by the District as a whole, and that there was no question that indigents were adequately served in District X. Petitioner will provide cardiac catheterization for indigents only on an emergency basis, and will rely upon Memorial to provide other indigent care. Based upon the testimony of Mr. Porter, the criteria with respect to indigent care, rule 10- 5.11(15)(h)3, F.A.C., has been satisfied. Since nearly all of the cardiologists on the staff of Hollywood Medical Center are also on the staff of Memorial Hospital, it is probable that Hollywood Medical Center would do a substantial number of catheterization procedures in the first year of operation, which is projected to be 1986. By the third year of operation, 1989, the Hollywood Medical Center facility would satisfy the requirement of rule 10-5.11(15)(i)4, F.A.C., that it annually perform at least 300 procedures within three years of initiation of service. For these limited purposes it is appropriate to consider the proximate population served, since this population is the most reliable source of patients and revenue. Most of the patients for the Hollywood Medical Center catheterization laboratory will come from its current actual service area, which was defined by the evidence to be a region in southern Broward County. Given the shared cardiologist staffing at both hospitals, it is not at all unreasonable to project that Hollywood Medical Center will service 30 percent of the need in the southern region of Broward County. Based on the 1983 Broward use rate, Hollywood Medical Center would do 518 catheterizations in 1989 if it handled only 30 percent of the need. Memorial would handle the remaining 70 percent, doing 1207 procedures annually. Even using the lower 1981 use rate provided by HRS, 329.5 per 100,000, Hollywood Medical Center would do 372 procedures in 1989, using the assumed market share of 30 percent. (As noted above, however, these figures do not demonstrate need, however, since existing facilities will be able to serve this same population adequately.) As already found above in calculation of need, rule 10- 5.11(15)(o)1 and 3, F.A.C., is satisfied if the 1983 use rate is used. Beginning with 1986, and in every year thereafter, there will be enough catheterization procedures needed so that the average volume for all facilities in the district will be at least 600 annually. HRS stipulated that if all other criteria were satisfied, the project proposed by Petitioner would be financially feasible. From the foregoing findings, all other criteria in dispute have been satisfied, and the project would be financially feasible. All other findings of fact proposed by the parties which have not been discussed above have been considered and have been deemed to be irrelevant.
The Issue The issues for determination in this case are whether the following statement was made by Respondent, AGENCY FOR HEALTH CARE ADMINISTRATION; whether the statement violates the provisions of Section 120.535, Florida Statutes; whether the statement constitutes a declaratory statement under Section 120.565, Florida Statutes; whether Petitioner, ALL CHILDREN'S HOSPITAL, INC., has standing to maintain this action; and whether Petitioner is entitled to attorney's fees and costs. The alleged agency statement which is at issue in this case is: The Agency for Health Care Administration takes the position that a shared service agreement may be modified, without prior approval of the Agency, as long as each party continues to contribute something to the program, and the shared service contract remains consistent with the provisions of Rule 59C-1.0085(4), Florida Administrative Code. In addition, the Agency takes the position that modifications to a shared service agreement do not require prior review and approval by the Agency.
Findings Of Fact Petitioner, ALL CHILDREN'S HOSPITAL, INC. (hereinafter ALL CHILDREN'S), is a medical facility located in St. Petersburg, Florida, which provides pediatric hospital care. Respondent, AGENCY FOR HEALTH CARE ADMINISTRATION (AHCA), is the agency of the State of Florida vested with statutory authority to issue, revoke or deny certificates of need in accordance with the statewide and district health plans. Intervenor, BAYFRONT MEDICAL CENTER (BAYFRONT), is an acute care hospital located in St. Petersburg, Florida. ALL CHILDREN'S and BAYFRONT are located adjacent to each other and are connected by a thirty-yard tunnel. In 1969, ALL CHILDREN'S began operation of a pediatric cardiac catheterization program. ALL CHILDREN'S pediatric cardiac catheterization program existed prior to the statutory requirement for a certificate of need to provide such service. Neither AHCA, nor its predecessor agency, Florida Department of Health and Rehabilitative Services, issued a certificate of need for ALL CHILDREN'S cardiac catheterization program. Since 1969, ALL CHILDREN'S has expended at least $500,000 on upgrading the cardiac catheterization program. Since 1970, ALL CHILDREN'S has operated a pediatric open heart surgery program. ALL CHILDREN'S open heart surgery program existed prior to the statutory requirement for issuance of a certificate of need to perform such service. Neither AHCA, nor its predecessor agency, Florida Department of Health and Rehabilitative Services (HRS), issued a certificate of need for ALL CHILDREN'S open heart surgery program. By letter dated May 13, 1974, HRS specifically advised ALL CHILDREN'S that modifications to the ALL CHILDREN'S open heart surgery program were not subject to agency approval. In May of 1973, ALL CHILDREN'S and BAYFRONT entered into a shared service agreement to provide adult cardiac catheterization services. In accordance with the shared service agreement, the actual catheterizations are performed in the physical plant of ALL CHILDREN'S and with equipment located on the ALL CHILDREN'S campus. BAYFRONT contributed to the adult cardiac catheterization shared service program by providing, inter alia, patients, management, medical personnel, and pre- and postoperative care. Beginning in 1975, BAYFRONT has also provided adult open heart surgery services through a joint program with ALL CHILDREN'S with the actual surgeries being performed at the physical plant on ALL CHILDREN'S campus. BAYFRONT contributed to the adult open heart surgery shared service by providing, inter alia, patients, management, medical personnel, and pre- and postoperative care. The shared service agreement between ALL CHILDREN'S and BAYFRONT to provide adult cardiac catheterization and open heart surgical services was in existence prior to the statutory requirement for a certificate of need to perform such services. Neither AHCA, nor its predecessor agency, Florida Department of health and Rehabilitative Services, issued a certificate of need to provide such services. The cardiac catheterization and open heart surgery program operated by ALL CHILDREN'S and BAYFRONT was "grandfathered" in because the program existed prior to the certificate of need requirement. Because no certificate of need was issued to ALL CHILDREN'S and BAYFRONT for its shared adult cardiac service program, no conditions have been imposed by AHCA on the operation of the program. "Conditions" placed on certificates of need are important predicates to agency approval and typically regulate specific issues relating to the operation of the program and the provision of the service such as access, location, and provision of the service to Medicaid recipients. The ALL CHILDREN'S and BAYFRONT cardiac shared services program is the only "grandfathered in" shared service arrangement in Florida, and is the only shared service arrangement operating without a certificate of need in Florida. An open heart surgery program is shared by Marion Community Hospital and Munroe Regional Medical Center in Ocala, Florida. The Marion/Munroe program operates pursuant to a certificate of need issued by AHCA. On December 22, 1995, AHCA published a notice of its intent to approve a certificate of need for a shared pediatric cardiac catheterization program between Baptist Hospital and University Medical Center in Duval County, Florida. BAYFRONT has applied for, but has not yet been issued, a certificate of need to perform cardiac catheterization services independent of the shared services arrangement with ALL CHILDREN'S. The agency receives hundreds of inquiries each year requesting information and guidance from health care providers regarding the certificate of need application process and other requirements of the certificate of need program. On more than one occasion ALL CHILDREN'S and BAYFRONT have inquired either orally or in letters to the agency regarding whether certain changes in their adult cardiac shared services program would require agency approval through a certificate of need application. In response to a 1990 written inquiry from ALL CHILDREN'S and BAYFRONT regarding modifications to the shared services agreement, the agency (then HRS) by letter dated September 18, 1990, stated in pertinent part that "the alterations you propose still constitute shared services." The agency response went on to state that it is therefore "...determined that they (the proposed changes) have not altered the original intent." On January 31, 1991, Rule 59C-1.0085(4), Florida Administrative Code, governing shared service arrangements in project-specific certificate of need applications was promulgated. The rule provides: Shared service arrangement: Any application for a project involving a shared service arrangement is subject to a batched review where the health service being proposed is not currently provided by any of the applicants or an expedited review where the health service being proposed is currently provided by one of the applicants. The following factors are considered when reviewing applications for shared services where none of the applicants are currently authorized to provide the service: Each applicant jointly applying for a new health service must be a party to a formal written legal agreement. Certificate of Need approval for the shared service will authorize the applicants to provide the new health service as specified in the original application. Certificate of Need approval for the shared service shall not be construed as entitling each applicant to independently offer the new health service. Authority for any party to offer the service exists only as long as the parties participate in the provision of the shared service. Any of the parties providing a shared service may seek to dissolve the arrangement. This action is subject to review as a termina- tion of service. If termination is approved by the agency, all parties to the original shared service give up their rights to provide the service. Parties seeking to provide the service independently in the future must submit applications in the next applicable review cycle and compete for the service with all other applicants. All applicable statutory and rule criteria are met. The following factors are considered when reviewing applications for shared services when one of the applicants has the service: A shared services contract occurs when two or more providers enter into a contractual arrangement to jointly offer an existing or approved health care service. A shared services contract must be written and legal in nature. These include legal partnerships, contractual agreements, recognition of the provision of a shared service by a governmental payor, or a similar documented arrangement. Each of the parties to the shared services contract must contribute something to the agreement including but not limited to facilities, equipment, patients, management or funding. For the duration of a shared services contract, none of the entities involved has the right or authority to offer the service in the absence of the contractual arrangement except the entity which originally was authorized to provide the service. A shared services contract is not transferable. New parties to the original agreement constitute a new contract and require a new Certificate of Need. A shared services contract may encom- pass any existing or approved health care service. The following items will be evaluated in reviewing shared services contracts: The demonstrated savings in capital equipment and related expenditures; The health system impact of sharing services, including effects on access and availability, continuity and quality of care; and, Other applicable statutory review criteria. Dissolution of a shared services contract is subject to review as a termination of service. If termination is approved, the entity(ies) authorized to provide the service prior to the contract retains the right to continue the service. All other parties to the contract who seek to provide the service in their own right must request the service as a new health service and are subject to full Certificate of Need review as a new health service. All statutory and rule criteria are met. By letter dated October 22, 1993, ALL CHILDREN'S and BAYFRONT inquired again of the agency regarding modifications of the adult inpatient cardiac shared service program. AHCA did not respond to the 1993 inquiry, and AHCA ultimately considered the inquiry withdrawn. By letter dated February 24, 1995, BAYFRONT made further inquiry of the agency, and requested agency confirmation of the following statement: The purpose of this letter is to confirm our understanding that the Agency for Health Care Administration ("Agency") takes the position that the shared services agreement between Bayfront and All Children's may be modified, without prior approval of the Agency, as long as each party continues to contribute something to the program, and that the shared services contract remains consistent with the provisions of Rule 59C-1.0085(4) F.A.C. By letter dated March 16, 1995, the agency made the following reply to BAYFRONT from which this proceeding arose: The purpose of this letter is to confirm your understanding of this agency's position with reference to the reviewability of a modifica- tion of the shared services agreement between Bayfront Medical Center and All Children's Hospital set forth in your February 24, 1995 letter.
The Issue Whether the Respondent committed the acts alleged in the administrative complaint contrary to Section 458.331(1)(t), Florida Statutes.
Findings Of Fact (Stipulated) The Respondent is and was at all times material to the allegations a licensed physician in Florida, holding license number ME 0050839 issued by the state. The Respondent was a board certified internist and board certified cardiologist practicing with Diagnostic Cardiology Associates at St. Vincent's Medical Center (St. Vincent's) at the time of the events which gave rise to these allegations. On or about June 25, 1988, W.V., referred to in the complaint as Patient #1, was admitted to St. Augustine General Hospital in St. Augustine, Florida. W.V. was a 68 year old male with a history of heart problems including four bypasses performed in 1977, a pacemaker implantation in 1979, chronic obstructive pulmonary disease, and prior prostate surgery. W.V. was determined to have had an acute myocardial infarction for which he was treated at St. Augustine General Hospital for five days. As W.V.'s condition improved, he was encouraged to walk at St. Augustine where he complained of chest pain and weakness. A echocardiogram showed segmental wall motion disturbance involving the posterior wall of the heart. A second electrocardiogram was performed which showed ventricular pacemaker rhythm and ST-T wave changes. On this basis, given his history and myocardial infarction, he was referred for a cardiac catheterization to St. Vincent's where his earlier heart surgeries had been performed. The patient was monitored during his hospitalization in St. Augustine, and did not show any signs of arrhythmias. On June 30, 1988, W.V. was transferred to St. Vincent's and received through the Emergency Room, where he was interviewed by the Respondent. After giving the Respondent a brief outline of his problems, W.V. was placed on a general medical floor for the evening, and scheduled for cardiac catheterization the following day. Cardiac catheterization and its risks were explained to W.V., who signed the patient consent forms authorizing the procedure. On the morning of July 1, 1988, after examining the patient and finding no changes, the Respondent performed on W.V. a cardiac catheterization, which verified the recent acute myocardial infarction, the blockage of two of the bypasses, damage to the heart muscle serving the lungs, and high vascular resistance with severe pulmonary hypertension. The patient tolerated the procedure well and showed no signs of arrhythmias during or after the procedure. The test results indicated that he could not benefit from surgery or angioplasty. W.V.'s primary health threat was from congestive heart failure, a condition likened to drowning in one's own fluids. (Tx-129, line 1.) A patient suffering from congestive heart failure will call for assistance from the nursing staff, as one of the expert's phrased it, "he would have been crawling out the door on his hands and knees calling for the nurse." (See Dr. Gilmore, Tx-130, line 8.) Conversely, heart failure alone would not have caused the patient to have chest pains, unless the patient developed elevated pressures to the point where pulmonary hypotension caused chest pain. However, the chest pain in such a case is not caused by clogged arteries or an impending heart attack, but by build up of fluid in the lungs which causes the heart to work harder to pump the blood through the lungs. (Dr. Campbell, Tx- 107, line 16.) The Respondent's post-catheterization order initially directed that W.V. be moved to a monitored bed following the procedure. The purpose of monitoring a patient is to observe, document and ultimately treat cardiac rhythm disturbances. (Dr. Gilmore, Tx-117,line 6.) Approximately 75 percent of post- catheterization patients were placed on telemetric monitoring (monitoring or telemetry hereafter). Monitored beds existed on 3 East (eight monitored beds), 5 East (eight monitored beds), Coronary Care Unit (eight monitored beds), Intensive Care Unit (12 monitored beds), and open heart unit which, although monitored, would not take catheterization patients. Notwithstanding the number of monitored beds, the critical piece of equipment is the monitor because each room on a monitoring unit was set up to receive telemetry. The monitor is a small radio transmitter that relays information from leads attached to the patient to receivers in each room. The monitors are removed by patients upon discharge, thrown into the laundry, and into the trash. They also require repair. As a result, the actual number of monitors varied from the planned number of monitored beds. Upon completion of the catheterization, the catheterization nurse would advise the nurse in charge of placing patients that the cardiac catheterization patient was ready for admission to the hospital, and whether the doctor had ordered a monitored or unmonitored bed. If the doctor had ordered a monitored bed and one was not available, the placement nurse would ask the admitting physician whether the patient being admitted really needed monitoring given the critical number of monitored beds available and the necessity to poll the treating physicians of all the monitored patients to see if any could be taken off monitoring. Inferentially, the Respondent considered the status of his other patients who were being monitored. If the physician deemed the patient's need for monitoring critical, then the placement nurse would poll the physicians of all other monitored patients, and request that they reassess the needs of their patients on monitoring. (See Lipsky Deposition, Page 26) The unit which normally received post-catheterization patients, 5 East, had eight monitored beds and eight unmonitored beds which were used as "stepdown" beds for patients taken off monitoring so that the monitors could be changed, but the patient retained in the same bed. Not only were all the monitored beds occupied on 5 East, the post-catheterization unit, but that unit had almost a full census. (See Lipsky Deposition, Page 20 - Page 26) The hospital's procedures required cardiac catheterization patients to remain in the catheterization laboratory until a monitored bed was available if the doctor stated that the patient was to go to a monitored bed. The catheterization patient would be held in the catheterization laboratory where there was a shortage of nursing care until a bed was found. Contrary to the experts' testimony which presumed the authority of the Respondent to place the patient in a monitored bed, it was the placement nurse who placed the patient once the doctor ordered a monitored bed post-catheterization. No evidence was received regarding her authority to place patients requiring monitoring in the ICU or CICU. Typically, doctors reassessed their patients' need for monitoring during morning rounds, and those that were stable were removed from monitoring so the monitor became available for a more critical patient. (See Libsky deposition, Page 24, line 20) W.V. catheterization was completed at approximately 11:00 a.m., following morning rounds when a maximum number of monitors should have been available; however, no evidence was received when a monitor would have been available. Testimony revealed that the wait could be as long as two hours for a monitored bed. During that time, under hospital protocols, W.V. would have remained in the catheterization lab. Contrary to facts assumed by the Petitioner's experts, the Respondent's options for placing the patient were: to place the patient in an unmonitored bed on the cardiac floor, or to retain the patient in a monitored bed in the holding area where he would be monitored by the cardiac catheterization nurse until the patient placement nurse found a monitored bed. The Respondent did not retain the patient in the cardiac catheterization area because the nurses could not adequately monitor W.V. and perform their other duties. The Respondent did not place W.V. in the Cardiac Care Unit or the regular Intensive Care Unit to obtain monitoring because it was not his function to place the patient. The only way he could have placed W.V. in CICU or ICU would have been to change W.V.'s status to justify the overall intensive care of the patient. However, this would have been unsupportable if questioned given the patient's condition which was stable upon admission six days after the myocardial infarction, and remained stable after the procedure. See Dr. Edwards Depostion, Page 41, line 19 et seq. Staffing levels on 5 East at the time of W.V.'s hospitalization were one nurse to four or five patients. There were five nurses, a charge nurse, and nursing assistant, and 22 beds on the unit. (See Lipsky Deposition, Page 72, line 15.) The Hospital's Standing Order 01-009 provided that "The critical care nurse, in consultation with the charge nurse, may initiate the following (list of nursing interventions) and notify the physician as soon as possible in the event of an acute deterioration [of] patient status and in the absence of a physician." (See Burnsed Deposition, Page 112, line 4) The Hospital Standing Order 01-017 provided "Any changes in the patient's condition will be called to the attention of the attending physician and appropriate consulting physicians. The emergency standing orders may be initiated by the nursing staff, but the physician must be informed of their use." (See Burnsed Deposition, Page 113, line 10) The Respondent placed the patient on 5 East, the cardiac care floor, in an unmonitored bed at approximately 11:50 a.m., as indicated by the notation on the patient's chart "nonmonitored," which indicated a change from the initial orders. (See Cavin Deposition, Page 34, line 7 and Page 35, line 7 et seq.) There was no order that W.V. should not be resuscitated. The Respondent's standing orders called for the patient's vital signs, together with shortness of breath and chest pain, to be monitored every 15 minutes for four hours. This was done until 3:15 p.m., when the monitoring was reduced to every 30 minutes. The Respondent advised the cardiac catheterization nurse, Mary Cavin, who accompanied the patient to the floor, of his findings, to include evidence of a recent myocardial infarction, and the patient's response to the procedure. (See Cavin Deposition, Page 19-20) Ms. Cavin identified her handwriting on the charts describing the Respondent's findings. However, these notes do not mention the recent myocardial infarction. The referenced notes were not sufficiently identified to check in the patient's charts. W.V. was taken to 5 East by Mary Cavin. Ms. Cavin had worked in this area at St. Vincent's for three years. Cardiac catheterization nurses were described by one of the experts as being among the best trained nurses in the profession, who because they work with the medical staff continuously during the procedures, are aware of the physician's findings and the patient's status. They pass this information along to the floor nurses when they transport the patients back to the floor. Ms. Cavin did not remember specifically W.V., but testified in her deposition regarding her normal practice when delivering a patient. She advised the staff on 5 East how the patient did during the catheterization, and what the findings had been. However, as stated above, in Cavin's notes she did not mention the recent myocardial infarction, and it is unclear whether she mentioned this to the staff of 5 East. The record is unclear to whom Ms. Cavin reported W.V.'s condition; however, Ms. Burnsed received a report on W.V. when she came on duty from Carolyn Johnson, the nurse who had cared for W.V. on the preceding shift. Ms. Burnsed was advised by Ms. Johnson that W.V. was stable post-catheterization, that he had previous open heart surgery, and that one of his grafts was blocked, but "had good collateral circulation to that." Further, Johnson advised Burnsed that W.V.'s vital signs were good, and he had no problems. Johnson did not mention the recent myocardial infarction suffered by W.V. Although Ms. Burnsed could not specifically remember her actions, her general course of action was to do a complete assessment upon starting the shift, make sure her patients were all right and having no problems, and orient them about the call light and calling her. Her physical assessment of W.V. revealed an apical heart rate of 72, respiration 18, and blood pressure of 100/70. W.V.'s vital signs were monitored by the staff of 5 East every 15 minutes as ordered by the Respondent until 3:15 p.m., when this was reduced to every 30 minutes. At 5:00 p.m., the Respondent saw W.V., who had no complaints and was stable. Ms. Burnsed found W.V. up going to the bathroom at 5:30 p.m., and got him back into bed explaining that it was important that he stay in bed because of his incision for at least 24 hours. Ms. Burnsed checked W.V.'s incision, and found that it was not bleeding at that time. At 7:00 p.m., Ms. Burnsed administered Lasix to W.V., and W.V. asked for and was provided sleeping medication at 9:00 p.m., at which time, Ms. Burnsed took W.V.'s vital signs which were essentially unchanged and stable. At 9:20 p.m. the patient's charts reflect that he was complaining of mild shortness of breath (SOB), and pains in his chest. Pursuant to the Respondent's orders, Ms. Burnsed administered nitroglycerin, 150 grains times one, after checking his blood pressure to insure it was within limits for the administration of nitroglycerine, and oxygen via nasal cannula, two liters, pursuant to emergency orders. This relieved the patient's symptoms. Ms. Burnsed did not report to the Respondent that W.V. had suffered mild shortness of breath and chest pain because the nitroglycerin and oxygen relieved his symptoms. The decision to notify or not to notify the treating physician was described as a nursing judgment based upon the nurse's assessment of the patient's condition after being medicated and placed upon oxygen. (See Lipsky Deposition, Page 56, line 8 et seq.) Ms. Burnsed did not consider the patient's condition to have deteriorated given his response to the medication, and did not notify the Respondent. Subsequent to administering the nitroglycerin and oxygen, Ms. Burnsed spoke with W.V.'s wife on the telephone. It is intimated in the depositions that Mrs. W.V. called to advise that her husband had called complaining of shortness of breath and chest pains and an inability to get anyone to assist him; however, no evidence was submitted regarding the content of the conversation between Ms. Burnsed and Mrs. W.V. Five to ten minutes after speaking with W.V.'s wife, Ms. Burnsed returned to W.V.'s room, where she found him resting in bed without complaint. W.V. stated that he wanted to go to sleep. Ms. Burnsed did not remember checking his vital signs on this second visit, and it is most probable that she did not because he was trying to go to sleep. Ms. Burnsed checked W.V. at 10:10 p.m., and found he was not breathing, had no pulse, and was unresponsive. The Cardiac Resuscitation Team was called, and responded. Despite their efforts, W.V. was pronounced dead at 10:50 p.m. Although a partial autopsy was performed which confirmed the findings of the catheterization and the diagnosis of a recent myocardial infarction, the cause of death was not precisely determined. It was assumed by the experts that W.V. did not die of congestive heart failure because he would have complained more. Therefore, the experts concluded that his death was relatively sudden, most probably brought on by an arrhythmia or perhaps a stroke. There was a suggestion that the Respondent did not put W.V. on a monitor because he had a pacemaker. While patients with pacemakers are at no less risk of developing arrhythmias than patients without pacemakers, there was no evidence that this was a consideration of Respondent in placing the patient on a cardiac floor following cardiac catheterization. It was general practice to place cardiac catheterization patients who exhibited signs of cardiac pathology on telemetry for 24 hours following the procedure. The initial orders of the Respondent were consistent with this practice. Testimony was received from the Petitioner's experts was that the Respondent's care was substandard because he did not place the patient on monitoring as they would have done by placing the patient in the emergency room, or the intensive care unit, or the cardiac intensive care unit to obtain telemetry monitoring, or retain the patient in the cardiac catheterization area pending the availability of a monitored bed. Their assumptions regarding the doctor's authority were inconsistent with the procedure for placing patients at St. Vincent's which was the function of the placement nurse. The Petitioner's experts also testified that placing a patient on telemetry notified the nursing staff that the patient required special attention. The Respondent's witnesses were more credible in stating that placing a patient on telemetry was not the way to indicate to nursing staff that the patient required special attention. The testimony of Respondent's witnesses that intensive care personnel were not as well trained as personnel on the cardiac floor to deal with cardiac emergencies is not credible. Both groups of personnel, if not equally versed in cardiac care, are sufficiently skilled in steps to be taken in the event of a cardiac emergency that there would be no appreciable difference in the care provided. Placing the patient in the regular intensive care unit or the cardiac intensive care unit would have required changing the patient's medical status be changed, and there was no change in the patient's condition which would have warranted the change. The patient was extremely ill upon admission, and his prognosis was very poor. W.V. was going to die because of his cardiac condition and chronic pulmonary congestion unless he had a stroke. His condition was irreversible in the opinions of the various experts; however, he would have been released the day following the catherization and treated medically for his problems. The Petitioner's experts opined that the Respondent's decision not to place W.V. in a monitored bed was substandard care because they felt that there was an ethical duty to monitor the patient in the absence of orders directing that efforts not be made to resuscitate notwithstanding the dismal chances for success. Their opinion assumed the Respondent could direct the placement of the patient in a monitored bed on a specific unit within a relatively short period of time because of all the monitored beds in the hospital. The Respondent's experts opined that the decision not to monitor W.V. was within the acceptable standards of medical care by physicians under similar circumstances, i.e., retain the patient in the catherization laboratory where nursing care would have been inadequate pending availability of a monitored bed for up to two hours. Their opinion considered the circumstances at St. Vincent's, and is deemed more credible.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the charges against the Respondent be dismissed. DONE and ENTERED this 2nd day of June, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, 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 2nd day of June, 1995. APPENDIX The parties filed proposed findings of fact which were read and considered. The following states which of those findings were adopted, and which were rejected and why: Petitioner's Recommended Order Findings Paragraph 1-3 Paragraph 1-3. Paragraph 4 Paragraph 5. Paragraph 5 Paragraph 3. Paragraph 6 Paragraph 6. Paragraph 7 While true, this finding is unnecessary to a consideration of the issues. Paragraph 8 Paragraph 7. Paragraph 9 Paragraph 9. Paragraph 10 Paragraph 32. Paragraph 11 Subsumed in Paragraph 37. Paragraph 12 Subsumed in Paragraph 38,39. Paragraph 13 Rejected as contrary to more credible evidence. Paragraph 14 If arrythmias were undetected, they would have been irrelevant to consideration of the patient's condition. Paragraph 15 Subsumed in Paragraph 9. Paragraph 16 Paragraph 46. Paragraph 17 Subsumed in Paragraph 9. Paragraph 18 Contrary to more credible evidence; See Parag 48. Paragraph 19 Rejected at Paragraph 43. Paragraph 20 Rejected at Paragraph 40. Paragraph 21 Rejected as contrary to more credible evidence; See Paragraph 12. Paragraph 22 Accurately states the expert's credentials, but is not relevant to consideration of the issues. Paragraph 23 Rejected as contrary to more credible evidence; See Paragraphs 42 and 47. Paragraph 24 Subsumed in Paragraphs 9,12,47-49. Paragraph 25 Rejected at Paragraph 16. Paragraph 26 See comments to Paragraph 22. Paragraph 27 See comments to Paragraph 23. Paragraph 28 While the may have been a national standard of care, there was not a national set of circumstances which impact the issue of whether the Respondent adhered to the appropriate standard of care. Paragraph 29 Subsumed in Paragraph 47. Paragraph 30 Subsumed in Paragraph 24. Paragraph 31 Subsumed in Paragraph 9. Respondent's Recommended Order Findings Paragraph 1 Paragraph 4,5. Paragraph 2,3 Paragraph 6. Paragraph 4 Paragraph 6,4. Paragraph 5 Paragraph 9. Paragraph 6 Rejected as contrary to most credible evidence; See Paragraphs 12-14. Paragraph 7-10 Subsumed in Paragraphs 17-19. Paragraph 11 Accurate; however, the patient was stable upon admission. Paragraph 12 Subsumed in Paragraph 46. Paragraph 13 Paragraph 46. Paragraph 14 Paragraph 24. Paragraph 15 Subsumed in Paragraph 25-28. Paragraph 16 Paragraph 24. Paragraph 17 Paragraph 31. Paragraph 18 Subsumed in Paragraph 33. Paragraph 19 Paragraph 37. Paragraph 20 Subsumed in Paragraph 46. Paragraph 21 Paragraph 38,48. COPIES FURNISHED: Hugh R. Brown, Esq. Agency for Health Care Administration 1940 N. Monroe St. Tallahassee, FL 32399-0792 Michael J. Obringer, Esq. Osborne, McNatt, Shaw, et al One Enterprise Center 225 Water St., Ste. 400 Jacksonville, FL 32202-5147 Marm Harris, M.D. Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esq. Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
