The Issue The issue in this case is whether the Petitioner's application for a certificate of need to establish a 20-bed skilled nursing home facility by conversion of 20 acute care hospital beds should be granted or denied.
Findings Of Fact Miami Heart Institute, Inc. (Miami Heart), is a licensed 258-bed acute care hospital located in Miami Beach, Dade County, Florida, specializing in the treatment of cardiovascular disease. Miami Heart has operated since 1944. It is a tertiary care hospital that provides extremely advanced care and treatment. As a tertiary care hospital, it frequently receives very high risk patients from the community and from other hospitals that do not feel capable of handling severe conditions. Most of its patient population consists of the affluent elderly. Compared to other hospitals in its community and statewide, Miami Heart's patient age is exceptionally high. Miami Heart is JCAHO hospital accredited. Miami Heart's application in this case proposes a 20-bed hospital based skilled nursing facility unit to be created by conversion of 20 existing acute care beds. The space allocated for the unit is currently unoccupied, except for overflow during the winter season. The rooms are all private rooms. The application does not define a particular patient class to be served in the proposed unit. The patients who would be served are the same patients now being served, primarily the affluent elderly, including the old elderly. There is no numeric need pursuant to the community nursing home rule for Miami Heart's proposal. Instead, the application is filed under the "not normal" or "special circumstances" provisions of the applicable rules. On the application form the Petitioner indicated that it sought to qualify under Rule 10-5.011(1)(b)1-4, Florida Administrative Code, and not under Rule 10- 5.011(1)(k)2.k., Florida Administrative Code. Miami Heart already has, in its physical plant, the beds these patients would occupy and the nursing station that would operate the proposed unit. The wing already exists in the hospital. The rooms are fully equipped. The nursing station only needs minor modifications to begin operation. Very little in the way of new capital expenditures need be made for this proposed unit to begin operation. In 1988 or 1989, Miami Heart had a tremendously high rate of decubitus ulceration among its patients; 25 percent of all patients in the hospital. Miami Heart has placed special emphasis on developing a team consisting of physicians and nurses to concentrate on preventing and curing decubitus ulcers (skin pressure sores) which are common in elderly patients who are relatively inactive or confined to hospital or nursing home beds. With the wound care program initiated by Nurse Beth Regan and Dr. Parry Larson that rate has been brought down to one percent, while the national average for hospitals is still 5 to 6 percent. Miami Heart staff is bringing its wound care knowledge and is providing decubitus care training to the staff of area nursing homes in an attempt to bring those dramatic improvements to those facilities. At the present time Miami Heart conducts extensive research into many areas of patient care and general medicine. These research projects include the treatment and prevention of pressure sores for which Miami Heart has pioneered much research into appropriate treatment methodologies. The research that is underway by the hospital at this time would work very well with the proposed unit should this certificate of need be issued. According to research performed by Mr. Jernigan, the average patient age in Florida hospitals over the age of 75 is approximately 22 percent. At Miami Heart, that same age category consists of fifty percent of the patients. Further, 68 percent of Miami Heart's patient days are for patients who are over the age of 75. Despite the advanced age of its patients, Miami Heart's mortality rate is particularly low. That attests to a very high standard of care provided at the hospital. All things considered, with regard to quality of care, Miami Heart is one of the finest hospitals in the state. At Miami Heart, the average length of stay of patients up to age 60 is eight or nine days. The average length of stay of its patients over age 70 is fourteen or fifteen days. It is routine for patients at Miami Heart to be treated by a team of different specialists because of the nature of complicating conditions that afflict them. Multi-system disease is the rule among patients at Miami Heart. If Miami Heart were given approval to begin operation of its proposed skilled nursing unit, it could continue to provide coordinated treatment and continue its team approach for the patients who would be good candidates for admission to this unit. These patients are, for the most part, suffering from a multiplicity of illnesses that require a team of specialists for complete treatment. Further, as opposed to transferring such patients to a nursing facility, there are many benefits to having a skilled nursing facility within a hospital itself. The physicians who tend to the patients will remain present for the continuity of care. A medical emergency can be handled in a very expeditious manner. Further, all lab work can be done on premises and the patient does not suffer through the difficulties associated with any transfer. Miami Heart also experiences a busy season during the winter months where seasonal residents greatly increase the local population. It is also more difficult to transfer patients to nursing homes during this winter season because nursing home occupancy is up significantly during those periods also. Miami Heart does not anticipate that its average occupancy rate of approximately 51 percent will increase if the proposed unit is approved. The acute census will probably decrease and the skilled unit census will probably increase commensurate with the decrease in the acute beds. In the proposed facility, Miami Heart intends to serve primarily patients from its own hospital. It proposes no Medicaid and very little indigent care. For that reason, the proposed service will not be accessible to all residents of the service district. At Miami Heart there are often times when there are patients in acute- care beds that do not need to be in such beds. A number of factors contribute to this. One factor is the expectation of care of the patient, the patient's family, and the treating physician. Because they know what to expect at Miami Heart, and because they know how to get there, patients and their families are often reluctant to have a patient moved to a nursing home. Patients at Miami Heart also often want private rooms, which are sometimes in short supply in area nursing homes. For a variety of other reasons, patients at Miami Heart often want to stay there and their treating physicians often want to keep them there, even though the patients do not need to be in acute-care beds. There are a variety of patients normally at Miami Heart who could, at any given time, be candidates for admission into the proposed skilled nursing facility. In a general sense all such patients would fall into a categorical description of not sick enough to require an acute care hospital bed. Among this type of patient are found several particular types. They include patients needing mechanical ventilation or chronic respirator patients. Another category of hospital patients who would be good candidates for the proposed unit would be patients receiving anti-coagulant medication through intravenous administration. Additional types of patients eligible for the proposed unit are those receiving I.V. therapy after having suffered congenital heart failure, cancer patients receiving intravenous chemotherapy, and certain patients suffering from diabetes. Diabetes is a common condition for elderly patients. The incidence of diabetes among Miami Heart Institute's patient population runs about 25-30 percent of all patients. An additional type of eligible patient is one who has received an implantable cardioverter defibrillator (ICD). At any given time there are also a number of wound patients at Miami Heart who would be good candidates for the proposed unit. Miami Heart has a high case mix index, which is an index of the severity of the illnesses treated at the hospital. The high case mix index is due in large part to the age of the patients and to the multiplicity of disease presented by the patients. Miami Heart's DRG-based reimbursement is adjusted to take into consideration this high case mix index. In other words, Miami Heart's reimbursement for a particular DRG category is higher than that of a hospital with a lower case mix index for the very same DRG category. There are approximately 7700 licensed nursing home beds in Dade County, which have an overall average occupancy rate of slightly more than 90 percent. Doctors Hospital has a 30 bed skilled nursing unit which is operating at approximately 61 percent occupancy. There are facilities in Dade County which provide ventilator services, IV therapy, decubitus care, hyperalimentation, and skilled rehabilitation. At Miami Heart discharge planning begins on admission, with a focus on "high risk" patients. Advance planning is undertaken to assure such things as home arrangements, meals-on-wheels, walkers, wheelchairs, and nursing home placements. Miami Heart routinely discharges patients to nursing homes in the area. The types of patients who have been successfully transferred to nursing homes or other less intensive care facilities include those who have had strokes and fractures, those requiring wound care treatment, and those requiring I.V. therapy, ventilator therapy, and physical therapy. Miami Heart's discharge planner has not been successful in transferring cancer patients receiving I.V. chemotherapy to area nursing homes and sometimes patients receiving I.V. Heparin drips have not been accepted by area nursing homes. Similarly, Miami Heart has not been able to place patients who receive I.V. Dopamine in any of the area nursing homes. Placement of patients in area nursing homes is generally more difficult during the winter season. Miami Heart has transferred several of its ventilator therapy patients to Vencor Hospital, which is a respiratory facility in Broward County. 1/ A current goal of the Office of Licensure and Certification is the promotion of restorative care in nursing homes and the training of nursing home staff in that area. Additional staff has been added in each of the HRS districts to promote restorative care within the long-term care system. Miami Heart could save on staffing costs by transferring patients to the skilled nursing facility, should it be approved. That is because the staffing requirements for acute care beds are greater than those for the skilled nursing facility. Miami Heart will not have to recruit a specialized nursing staff to run the proposed unit. Adequate skilled staff is already on hand at Miami Heart that now performs all the functions, in an acute care setting, that would need to be performed for the services proposed in the skilled nursing facility, at a less intensive level of care. Costs for hospital based skilled nursing units are generally higher than costs of community based skilled nursing units. The actual cost of the space being converted to provide the proposed service at Miami Heart is three and one-half times higher than other skilled nursing facility development within the state of Florida, and two and one-half times greater than normal hospital costs. However, this is to a large extent an artificial number because most of the cost for the space has already been spent. Very little "new" money will be necessary to implement this project. One of the primary benefits of the proposed unit to Miami Heart would be to reduce the length of stay in the acute setting. This would be cost effective for the hospital. For its acute patients, Miami Heart Institute, Inc., is reimbursed by Medicare based upon a prospective payment system. This system provides for a flat sum payment for a category of diagnosis. The amount of reimbursement is the same whether the patient stays one day or 100 days, unless the stay becomes an outlier, in which case the hospital receives additional reimbursement. Sometimes the hospital has a windfall, in that the patient goes home earlier than average, and sometimes the patient stays longer than average. The reimbursement system neither requires nor permits the hospital to discharge a patient simply because its "DRG" has run out. In the proposed unit, Miami Heart would receive the DRG for the acute portion of the stay, plus a cost based per diem reimbursement for the skilled nursing portion of the stay. Financial feasibility can consist of several things. The project can make a profit, it can generate goodwill, or it can result in the hospital losing less money than without the project. If this project is implemented it will have an overall positive financial effect on Miami Heart. The project will assist Miami Heart in generating revenue and it will reduce the costs that it experiences for some of its patients that have extended lengths of stay. That would be a positive financial benefit to the hospital and would render the project financially feasible. Miami Heart has sufficient resources for project accomplishment. Miami Heart's architectural plans are satisfactory with the exception of a few details which can be corrected. The 1989 State Health Plan contains twelve application preferences. As noted more specifically in the paragraphs which follow, Miami Heart's application is consistent with the letter of most of the preferences in the State Health Plan and appears to be consistent with the spirit of most of the rest. The first preference reads "Preference shall be given to applicants proposing to locate nursing homes in areas with sub-districts with occupancy rates exceeding 90 percent." The occupancy of existing nursing homes in Dade County is slightly more than 90 percent. Thus, Miami Heart's application would meet this preference. The second preference reads, "Preference shall be given to applicants who propose to serve Medicaid residents in proportion to the average subdistrict-wide percentage of the nursing homes in the same subdistrict. Exceptions shall be considered for applicants who propose to exclusively serve persons with similar ethnic and cultural backgrounds or propose the development of multi-level care systems." Miami Heart does not propose to serve any Medicaid patients nor does it propose to serve persons with similar ethnic or cultural backgrounds. However, the proposed unit would constitute the development of multi-level care systems. Accordingly, it would be consistent with this preference. The third preference reads, "Preference shall be given to applicants proposing to provide specialized services to special care residents, including AIDS residents, Alzheimer's residents, and the mentally-ill." Although the application does not propose to provide specialized services to any of the listed special care groups, it does propose to offer specialized services to a group of the very old; specifically, the very old patients who are treated at Miami Heart. Therefore, the proposal is consistent with the third preference. The fourth preference provides that, "Preference shall be given to applicants proposing to provide a continuum of services to community residents, including, but not limited to, respite care and adult day care." Miami Heart is not proposing to provide either respite care or adult day care. The proposed project would, however, provide a continuum of services to the patients at Miami Heart. Accordingly, it appears to be consistent with this preference. The fifth preference provides that, "Preference shall be given to applicants proposing to construct facilities which provide maximum resident comfort and quality of care. These special features may include, but are not limited to, larger rooms, individual room temperature controls, visitors' rooms, recreation rooms, outside landscaped recreation areas, physical therapy rooms and equipment, and staff lounges." The application forwards this preference in several ways. First, the patient rooms would be large, well-equipped, and well placed. Second, and most importantly, the proposed unit would advance quality of care by allowing patients who no longer require acute care to remain at Miami Heart where they can receive quality of care that is among the very best in the State of Florida. The sixth preference reads: "Preference shall be given to applicants proposing to provide innovative therapeutic programs which have been proven effective in enhancing the residents' physical and mental functional level and which emphasize restorative care." The wound care program presently offered at Miami Heart meets this description. The seventh preference provides: "Preference shall be given to applicants proposing charges which do not exceed the highest Medicaid per diem rate in the subdistrict. Exceptions shall be considered for facilities proposing to serve upper income residents." Although Miami Heart does not expect to serve any significant number of Medicaid patients, the proposal meets the exception stated in the preference because most of the patients at Miami Heart Institute are upper income patients. The eighth preference reads: "Preference shall be given to applicants with a history of providing superior resident care programs in existing facilities in Florida or other states. HRS' evaluation of existing facilities shall consider, but not be limited to, current ratings of licensure facilities located in Florida." Miami Heart does not have an existing nursing care program and has no licensure rating for such a program. Nevertheless, it is reasonable to assume from Miami Heart Institute's commitment to high quality of care in its hospital operation that it will adhere to those same high quality standards in the proposed project. Thus it meets the spirit, if not the letter, of this preference. The ninth preference reads: "Preference shall be given to applicants proposing staffing levels which exceed the minimum staffing standards contained in licensure administrative rules. Applicants proposing higher ratios of RNs and LPNs to residents than other applicants shall be given preference." Miami Heart's application forwards this preference. The tenth preference reads: "Preference shall be given to applicants who will use professionals from a variety of disciplines to meet the residents' needs for social services, specialized therapies, nutrition, recreation activities, and spiritual guidance. These professionals shall include physical therapists, mental health nurses, and social workers." Miami Heart Institute's long history as a provider of the highest quality of care is indicative of the likelihood that the proposed project would forward this preference. The eleventh preference reads: "Preference shall be given to applicants who document how they will ensure resident's rights of privacy, if they use resident councils, and if they plan to implement a well-designed quality-assurance and discharge-planning program." Miami Heart has documented its existing programs regarding resident's rights, quality-assurance, and discharge-planning, and it is reasonable to assume that the same or substantially similar programs would be implemented in the proposed project. Such implementation would forward this preference. The final preference in the State Health Plan provides that "Preference shall be given to applicants proposing lower administrative costs and higher resident care costs compared to the average nursing home in the district." The applicant did not provide information upon which this preference could be assessed. The 1989 District XI Health Plan contains CON allocation factors for nursing home services. The allocation factors include 16 paragraphs of "Recommendations," some of which are absolute requirements and some of which are preferences. The first and second paragraphs of the recommendations have to do with programs which can serve the mentally ill and mentally retarded. The preferences expressed in these two paragraphs are not advanced by the subject proposal. The third paragraph provides that, "all else being equal, preference should be given to applicants who propose to fill a demonstrated unmet need in the community by offering a special service, e.g., for ventilator patients, AIDS patients, young disabled patients." Miami Heart does propose to offer ventilator services. However, there is no quantified demonstrated need for that service. Because the record in this case does not establish a demonstrated unmet need, this preference is not advanced by the proposal. The preference in the fourth paragraph relates to nursing home projects in geographic areas of greatest need based on population age 75+ and on the occupancy rate in the proposed service area. This preference is furthered by the subject proposal. The preference in the fifth and sixth paragraphs (both of which are identical) are for applicants proposing to provide care to patients not covered by Medicare who are medically indigent. These preferences are not advanced by the subject proposal. The preference in the ninth paragraph is for facilities proposing to offer a comprehensive scope of services. This preference is advanced by the subject proposal. The tenth paragraph of the Recommendations addresses compliance with all federal safety requirements and all state nursing home regulations. The subject proposal is in compliance with this requirement. The preference in the eleventh paragraph is for applicants "which have superior ratings according to Florida's Department of HRS." Miami Heart has such a rating. Accordingly, the subject proposal advances this preference. Paragraph twelve of the recommendations requires an approved patient bill of rights. The subject proposal is in compliance with this requirement. The fourteenth paragraph expresses a preference for applicants providing adequate visitor parking and outside recreational opportunities for patients. Although there is not much evidence bearing directly on this matter, in light of the high quality of every other aspect of the Miami Heart facility, it is more likely than not that the subject proposal is consistent with this preference. The fifteenth paragraph expresses a preference for applicants that document plans for formalized patient transfer mechanisms. This preference is advanced by the subject proposal. The preferences identified in paragraphs 7, 8, 13, 16, 17, and 18 of the recommendations portion of the local plan are not applicable to the subject proposal. In sum: of the twelve paragraphs of preferences and requirements that are applicable to the subject proposal, seven are satisfied or forwarded by the proposal and five are not. Appendix 1 (1B2) of the Petitioner's application alludes to "internal studies" of "Difficult to Place" patients from January through October 1989. Table 3 shows that there were 57 such patients, which is annualized to 68 such patients. There is no information in the application or in the record of this case regarding how the internal studies were conducted or what criteria were used to classify some of the patients as "difficult to place." Of the 57 patients listed as "difficult to place," 5 are categorized as "nursing home declined to accept" and 13 are categorized as "no nursing home beds available." Neither the application nor the evidence offered at hearing includes documentation of patients' need for nursing home care in the form of the attending physicians' plans of care or orders. Neither the application nor the evidence offered at hearing includes any assessments performed by staff of the Department of Health and Rehabilitative Services indicating need for nursing home care. Neither the application nor the evidence offered at hearing includes any equivalent assessments performed by attending physicians indicating need for nursing home care. For a six-month period during 1989, Miami Heart compiled statistics on the number of patients at Miami Heart who could be appropriately transferred to a skilled nursing facility and who met Medicare eligibility criteria for transfer to a skilled nursing facility. The statistics show that there are an average of 5.6 new patients each week of the type described above. A conservative estimate of their average length of stay would be 17 days. Based on those patient numbers and length of stay, it is reasonably anticipated that the proposed facility could achieve an average daily census of 13.5 within three or four weeks of operation and could continue to maintain such a census level indefinitely. An average daily census of 13.5 would be an occupancy rate of 67.8 percent. 2/
Recommendation Based on all of the foregoing, it is RECOMMENDED that the Department of Health and Rehabilitative Services issue a Final Order in this case denying the Petitioner's Application for a 20-bed skilled nursing unit. RECOMMENDED in Tallahassee, Leon County, Florida, this 18th day of March 1991. 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 18th day of March 1991.
The Issue The issue presented is whether Petitioner's application for a certificate of need to establish a hospice with a six (6) bed component to be located in Dade County, Florida, should be approved.
Findings Of Fact The Parties Since 1975, Petitioner, Comprehensive Home Health Care, Inc., has been serving the elderly population of Dade County, primarily working with the Hispanic community to provide skilled nursing services and the services of physical therapy, speech pathology, occupational therapy, home health aide and medical social services. Petitioner currently provides its services as a home health care agency licensed by the Department. Respondent, Department of Health and Rehabilitative Services (Department), is a state agency which is responsible for administering Section 381.701 through 381.715, Florida Statutes, the "Health Facility and Services Development Act", under which applications for certificates of need (CON) are filed, reviewed and either granted or denied by the Department. Petitioner currently does not participate in an approved hospice program. Two hospice programs are licensed by the Department to serve Dade County: Catholic Hospice, Inc., and Hospice, Inc. Neither entity chose to intervene in the instant proceeding. The Application On or about March 27, 1989, Petitioner filed an application with the Department for a CON to implement a six (6) bed hospice service in Dade County, Florida, with no capital expenditure. The application was designated as CON Number 5871. No public hearing was requested. After the submittal of an omissions response, the Department deemed the application complete on May 16, 1989. The application was reviewed as the sole applicant in its batching cycle After review of the application, the Department issued its intent to deny the application in its state agency action report (SAAR) on June 29, 1989. In the application, Petitioner proposes to establish a not-for-profit, full service hospice which includes a six (6) bed inpatient component with beds to be located in the Northwest, Central West and Southwest Dade County, Florida, in three of the following hospitals: AMI Kendall Regional Medical Center Coral Gables Hospital North Gables Hospital Palmetto Hospital Pan American Hospital Westchester Hospital In addition to relying on its application as meeting pertinent statutory and rule criteria- Petitioner asserts that the application demonstrates mitigating and extenuating circumstances which would allow the approval of the application even if the numeric need prescribed by rule were not demonstrated by the application. Further, the application states that Hospice, Inc., as the only provider in Dade County, has a monopoly on the market in Dade County. Petitioner also intends to concentrate on providing service to the Hispanic population and those individuals suffering from AIDS. The application was not presented in the format which the Department usually receives applications for certificate of need. The usual format was not made part of the record in this proceeding. However, the application, as supported at hearing, shows Petitioner's desire to provide hospice services to the residents of Western Dade County. The witnesses testifying on behalf of Petitioner were Teresa Corba Rodriguez, Roger Lane and Rose Marie Marty. Ms. Rodriguez is an experienced registered nurse who worked for Hospice, Inc., from November, 1987, through June, 1989. She is currently employed at Victoria Hospital. Mr. Lane is the director of information and referral at Health Crisis Network in Miami, and Ms. Marty is the Vice President of Petitioner. The Department's primary bases for issuance of its intent to deny the application were the lack of need for additional inpatient hospice beds, and the failure to document sufficiently certain statutory and rule criteria, as discussed in the following paragraphs. The Department offered the testimony of Elizabeth Dudek, who is an employee of the Department, and is an expert in health planning. Compliance with Statutory Criteria In its proposed recommended order, the Department acknowledged that only six statutory criteria in Section 381.705(1), Florida Statutes (1987) are at issue, in addition to Rule 10-5.011(1)(j), Florida Administrative Code. State Health Plan Although the State Health Plan was not offered into evidence, the Department through testimony and the SAAR indicates that the Application conforms to the State Health Plan. Local Health Plan The applicable Local Health Plan is represented by the plan entitled, "1988 District XI Certificate of Need Allocation Factors", adopted on March 3, 1988. This plan, as it relates to hospice services, is composed of a Subsystem Description, a statement of Issues and of Recommendations. The SAAR chose to base its determination of Petitioner's compliance with the local health plan on an evaluation of whether the application fulfilled the several preferences within the recommendations portion of this plan. In so doing, the Department determined in its SAAR that the Petitioner was in partial compliance. The first preference reads as follows "Preference should be given to applicants having a workable plan for training and maintaining a corps of volunteers." Petitioner demonstrated its consistency with this preference by utilizing volunteers who are bilingual and who will assist in performing the clerical, visitation, counseling, public relations and community awareness aspects of the program. Petitioner also intends to rely on the volunteer efforts of the servicing hospital, churches, schools, community functions, educational efforts and media to enhance community awareness about the program. The second preference reads as follows, "Preference should be given to those applicants who propose to provide care for the indigent and medically needy." Petitioner demonstrated its consistency with this preference by proposing to provide ten (10) percent of its total patient day for Medicaid recipients, and five (5) percent of its total patient days to the medically indigent, at least, during the first year of operation. The third preference reads as follows, "Preference should be given to those applicants who propose a commitment to serving persons with AIDS." Petitioner demonstrated its consistency with this preference by stating both in the application and through the testimony of its witnesses that it intends to serve the ever-increasing number of patients diagnosed with AIDS. Further, it is one of Petitioner's long range objectives to seek funding sources and grants to provide additional services to AIDS patients. The fourth preference reads as follows: "Preference should be given to those applicants who can demonstrate or have entered contractual agreements with other community agencies to ensure a continuum of care far those in need." Petitioner's application is consistent with this preference by its claim that the hospitals set forth in paragraph 6 intend to participate in the program, and should supplement the home health care system which Petitioner currently maintains. However, no competent proof was offered in support of the proposed arrangements. The fifth preference reads as follows: "Preference should be given to those applicants who have developed specialized innovative services to special sub-population in need within the District." Petitioner demonstrated its partial consistency with this preference by showing its intent to service patients with AIDS, the elderly and the Hispanic sub-populations of Dade County. However, Petitioner failed to show that the service it would provide was different from the service provided by the existing hospices in Dade County, other than the intended geographical location of Petitioner's proposal. Siting in Western Dade County on its own was not shown to be a specialized, innovative offering. The sixth preference reads as follows: "Preference should be given to those applicants who will address specific needs of the culturally diverse minority populations in the District." Petitioner demonstrated its consistency with this preference by showing that it intends to serve the elderly, ethnic minorities, victims of AIDS, and the indigent populations of Dade County. Each of the groups Petitioner has singled out are indeed minority population groups within Dade County, and are elements of, and contribute to the cultural diversity of the area. The seventh preference reads as follows: "Preference should be given to those applicants who propose to have health care personnel on call during night and weekend hours." Petitioner demonstrated its consistency with this preference by showing its intent to provide for home care up to24 hours a day, 7 days a week, to control its patients' symptoms and respond to emergencies as needed. The eighth preference reads as follows: "Preference should be given to applicants who build quality assurance methods into the proposed program." Petitioner demonstrated its consistency with this preference by expressing its plan to install a quality assurance program which will include clinical records review by a registered nurse, ongoing clinical record review, and utilization review. On balance, the Petitioner's application is consistent with the Local Health Plan. Availability, Accessibility and Extent of Utilization Currently there are two hospices that serve the District. The two are located in the Eastern portions of the County. Petitioner intends to locate its beds in the Northwest and Southwest portions of Dade County, whereas the existing beds are housed in the Northeast and Southeast parts of the County. Thus, Petitioner's proposed beds are more geographically accessible to the residents of Western Dade County, which the application asserts is the fastest growing area of the County. By providing beds in the Western portion of the District, and in locations different from the existing beds, Petitioner would make the hospice services in the District more geographically accessible. Hospice, Inc., is currently licensed for twenty- five (25) beds, of which only between fourteen (14) to sixteen (16) are operable. The record is silent as to the availability of the thirty (30) beds approved for Catholic Hospice, Inc. The record does not indicate why the approved beds are not in service, or how the beds requested by Petitioner would improve the availability of hospice service in the District. Quality of Care, Efficiency, Appropriateness and Adequacy The Application suggested that patients suffering from acquired immune deficiency syndrome (AIDS) are underserved, and that Petitioner will fulfill that need. Testimony offered by Petitioner sought to establish that some patients suffering from AIDS, and those of Hispanic origin, had been refused service by the existing hospices, and made vague reference to some credit problems which Hospice, Inc., had experienced If proven, the statements might impact on the quality of care, efficiency, appropriateness and adequacy; however, without a more direct showing this testimony is not considered, substantial, or credible. As to other references concerning the quality of care, efficiency, appropriateness and adequacy, the record is again silent. Availability and Best Use of Resources Petitioner currently operates as a home health care agency. The hospice program would be an extension of the existing service offered by Petitioner and targeted to serve the Hispanic, elderly and terminally ill patients within the District, utilizing existing and voluntary personnel. Without demonstrating more about the current operations, and proof of the market demand for the proposed services, a determination of the best use of resources cannot be made. Financial Feasibility The application projects a financially sound forecast in the short-term through 1991 starting with $75,000 available. The Department through testimony and in the SAAR recognized the short- term financial feasibility of the project. However, the record is silent on financial projections past 1991. Accordingly, a determination of the long-term financial feasibility of the proposal has not been shown. Effects on Competition Petitioner asserted that eligible patients were not being served by the existing facilities, as discussed in above paragraph 24. To the extent these underserved patients exist and were to be provided for by the proposed program, the offering might have an impact on the costs of providing health services in the District. However, as discussed in paragraph 24, the evidence presented did not support Petitioner's claim. Compliance with Rule Criteria Rule 10-5.011(1)(j), Florida Administrative Code, sets forth the Department's methodology for calculating the numeric need for hospice services within a particular service area. Dade County is the pertinent service area for the evaluation of the application. The methodology provides a formula by which the total number of hospice patients for the planning horizon, in this case January, 1991, are to be estimated. The formula takes the cancer mortality rate in the district, and factors in a certain percentage to allow for any other types of deaths, and then factors in considerations of both long-term, and short-term hospital stays to yield the projected number of beds which will be needed in the horizon year. For the batching cycle in which Petitioner's application was reviewed, the projected bed need is fifty-nine (59). From that figure, the number of approved beds is subtracted. At the time Petitioner submitted its letter of intent, the inventory of licensed beds in the District indicated that Catholic Hospice, Inc. was approved for thirty (30) beds, and Hospice, Inc., for twenty-five (25) beds. In other words, the inventory of licensed approved beds applicable to this application is fifty-five (55) beds. Thus, the numeric need for the pertinent batching cycle is four (4) beds. As referenced in paragraph 5, Petitioner requested approval for six (6) hospice beds. The application contains no request for approval of less than six (6) beds, nor did Petitioner raise the issue of a partial award. The Department does not normally approve an application when numeric need is not met unless, in the instance of a request for hospice services, mitigating and extenuating circumstances are proven by demonstrating the following: (1) documentation that the population of the service area is being denied access to existing hospices because the existing hospices are unable to provide service to all persons in need of hospice care and service, and, (2) documentation that the proposed hospice would foster cost containment, discourage regional monopolies and promote competition for all providers in the health service area. Hospice Inc., frequently maintains a waiting list for its hospice beds; however, the reason or reasons for the list was not demonstrated. The census of the hospice beds at Catholic Hospice, Inc., was not discussed at the hearing, or in the application. All of Petitioner's witnessed testified that they believed that the existing hospices were unavailable to potential patients in need of hospice service who lived in the Western portion of the District because the existing hospices were located in the Eastern portion of the District. The travel time from the Southern portion of the District to the Northernmost existing facility can require up to two and one-half hours. The witnesses asserted that the patients and their families do not wish to travel for that period of time to receive the services or to visit patients in the existing hospices. However, no patient or family member testified that the travel time or location of the existing hospice were a hindrance to care. The testimony presented concerning the patients and their families is not competent or corroborated by competent evidence. Further, Petitioner's witnesses asserted that doctors who had treated patients eligible for hospice service had told the witnesses that the physicians hesitated to refer the patients to the existing hospices because the doctors might not have staff privileges at the hospitals which house the existing beds. Again, no physicians were available to corroborate the statements of the witnesses or offer competent testimony in support of these assertions. Although Hospice, Inc., is Licensed for twenty- five (25) beds, it has chosen to operate only between fourteen (14) to sixteen (16) of those beds. The reasons Hospice, Inc., has chosen not to operate all of its licensed beds were not offered in the record. The District has the largest number of AIDS diagnosed cases of any county in Florida. The number of cases in the District is doubling, more or less on a yearly basis. The incidence of AIDS cases adds to the number of person in need of hospice care in the District. Rule 10-5.011(1)(j) does not single out AIDS-related deaths in its calculation; however, deaths from other than cancer are factored into the formula. Again, no competent testimony was presented that the existing hospices were unable to serve patients suffering from AIDS. The methodology set out in Rule 10-5.011(1)(j) determines the initial need for hospice within the District. Once a hospice has been approved, it can increase the number of beds that it has without certificate of need approval as long as the hospice keeps a patient mix of twenty (20) percent inpatient to eighty (80) percent outpatient. The factors asserted in findings 33-37 would go to show mitigating and extenuating circumstances, if proven by competent substantial proof. However, from the evidence presented, it cannot be determined that the existing hospices are unable to provide service to those in need of hospice care. The evidence presented to document that the proposal would foster cost containment, discourage regional monopolies, and promote competition is discussed in paragraphs 25-28 above, and is lacking in substance to show the premise raised here.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is: RECOMMENDED that the Department of Health and Rehabilitative Services issue a Final Order which denies CON Application Number 5871. DONE AND ENTERED in Tallahassee, Leon County, Florida,, this 13th day of February, 1990. JANE C. HAYMAN 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 13th day of February, 1990.
The Issue Whether Respondent, Agency for Health Care Administration (Agency) should have issued Petitioner, Haverhill Care Center and Beverly Health Care West Palm Beach, Beverly Enterprises-Florida, Inc., d/b/a Beverly Gulf-Coast Florida (Haverhill), a conditional license for the periods October 14, 1998, through January 3, 1999, and December 8, 1999, through February 9, 2000.
Findings Of Fact At all times material hereto, the Agency was the enforcing agency with regard to nursing home licensure law pursuant to Chapter 400, Part II, Florida Statutes. Haverhill is a nursing home located in West Palm Beach, Florida. On October 14, 1998, the Agency surveyed Haverhill and determined that the facility violated 42 CFR Sections 483.13(c), 483.25(h)(2), and 483.75 in its care of B. B., a resident at the facility who had eloped from Haverhill on September 24, 1998. The deficiencies were described by tag numbers F224, F324, and F514. The Agency determined that these deficiencies were Class II deficiencies under the state rating scheme and the Agency also assigned them a severity rating of "G", which is a determination under the federal rating scheme that the deficiency was isolated but caused actual harm to the resident. B. B. was a 78-year-old male who had dementia, congestive heart failure, hypertension, and a history of a pulmonary embolism. He was independent with his daily activities and ambulatory. From the end of 1997 through September 1998, B. B. underwent a series of admissions and discharges from different short-term and long-term care facilities. In late 1997, he went to the hospital with congestive heart failure, and while he was there, his doctor recommended that he be placed in a long-term care setting. After his discharge from the hospital, B. B. went to a nursing home known as IHS Lake Worth, where he remained until May of 1998. In May 1998, B. B. experienced a pulmonary embolism and was sent to the hospital. Staff from IHS Lake Worth sent a transfer form to the hospital that noted that B. B. was a "wanderer" and would "go outside if not monitored." When B. B. was discharged from the hospital in late May 1998, he could not go back to IHS Lake Worth because the Agency had placed a moratorium on admissions to IHS Lake Worth. B. B. was sent to a sister facility, IHS of West Palm Beach, where he remained until July 6, 1998. During his stay at IHS of West Palm Beach, staff at the facility noted that B. B. "wanders at times, needs direction." On July 6, 1998, B. B. was discharged to his home, where he remained until August 5, 1998, when his daughter S. B. determined that she was unable to care for him and readmitted him to IHS Lake Worth. While at IHS Lake Worth, B. B. was given Haldol, an anti-psychotic drug. He was also assessed by the staff on August 6, 1998, as being appropriate for a locked unit due to "wandering and confusion and past history of agitation and combativeness." During the next few days, B. B. exhibited episodes of angry outbursts and agitation, which caused staff to be fearful for others. On August 12, 1998, B. B. was transferred to Four Seasons, an assisted living facility. The record review on August 12, 1998, recorded, "Four Seasons came and evaluated and took resident upon assessment. Daughter agreeable. Doctor agreeable. Locked unit most appropriate place for this resident." Four Seasons was closed by the Agency. While the facility was being closed, B. B. got on a bus. The Delray Beach police found him and returned him to the facility After Four Seasons closed, B. B. returned home. While at home, B. B.'s behavior became erratic. He would get up at 4:00 a.m. and take a shower. B. B. was being given Ativan to calm him down. On September 16, 1998, B. B. was readmitted to IHS West Palm Beach, which had a Wanderguard alarm system designed to notify staff if a patient attempted to leave the facility. However, the Wanderguard system at IHS West Palm was not fully functional. While at IHS West Palm Beach, B. B. wandered around the facility and attempted to get out of the facility. The administrator at IHS West Palm Beach determined that B. B. needed to be transferred to another facility. At approximately two o'clock on Friday afternoon, September 18, 1998, Kit Johnson, the Social Services Director at IHS West Palm Beach, spoke with S. B. and advised her that B. B. needed to be transferred to a more secure facility. Ms. Johnson contacted several facilities in an effort to find a facility which would accept B. B. She spoke to Robb Eason, Haverhill's Admissions Director, concerning placement for B. B. She advised Mr. Eason that IHS West Palm Beach could not keep B. B. because he was a wanderer and could not be maintained safely at IHS West Palm Beach. Mr. Eason agreed to have B. B. transferred to Haverhill. Ms. Johnson called S. B. and advised her that Haverhill was willing to take B. B. S. B. indicated that she could not be there because her mother was ill. At four o'clock, nursing staff at IHS West Palm Beach were notified that B. B. would not be transferred until the next day because S. B. could not come to the facility until the next day. B. B. became very upset because his daughter was not coming and walked off the unit. A security guard had to be called to return B. B. to his room. A decision was made that B. B. would be transferred to Haverhill on September 18, 1998. At 5:00 p.m., the nursing staff at IHS West Palm Beach was notified that B. B. would be transferred. B. B.'s doctor's service was called for a discharge order. At 5:45 p.m. B. B was transferred to Haverhill by a transport service. The documents that were sent to Haverhill to IHS West Palm Beach did not indicate that B. B. was a wanderer or that he could be a candidate for elopement. Between five and six o'clock on the afternoon of September 18, 1998, S. B. telephoned Mr. Eason and advised him that she could not come to Haverhill that Friday because her mother was ill. Mr. Eason told her that he would not be back in the facility until the following Monday and suggested that she come the next day to complete the paperwork with the charge nurse. S. B. did not feel comfortable doing the paperwork with the charge nurse and told Mr. Eason that she would come on Monday. S. B. also asked Mr. Eason if he had spoken to Kit Johnson and whether he was aware that Ms. Johnson had told her that Haverhill was a locked-down facility. S. B. also asked Mr. Eason whether Haverhill could deal with her father's dementia. Eason told her that Haverhill could handle B. B. On B. B.'s first day of admission at Haverhill, September 18, 1998, he was agitated at being placed in a nursing facility. S. B. received a call from one of the nurses at Haverhill during the evening, telling her that B. B. did not know why he was at the nursing home, but that they would take care of him. A care plan was developed for B. B. on September 18, 1998, to deal with his agitation at being placed in a nursing facility. The care plan included the following approaches: Introduce yourself and knock on door prior to entering room. Orient to room and new environment. Encourage to express his feelings about nursing home placement. S/S to visit to promote conversation weekly. Activity to visit & (illegible) to activity of choice daily. Call bell within reach when in room. The care plan did not include measures to deal with B. B.'s wandering of which Mr. Eason had knowledge. On the morning of September 19, 1998, B. B. was alert and oriented to his surroundings. He told the nurse, "I really like this place, you should have seen the hell hole I came from." B. B. called his daughter on September 19, 1998, and told her that he was waiting for her and that he was ready. She explained that her mother was sick and she could not be left at that time. B. B. seemed to accept that explanation. On September 20, 1998, B. B. awoke about 4 a.m. and walked in the hall. He was angry and belligerent when his doctor visited him. He had yelled at other residents and kept asking for a sleeping pill all day. At the beginning of the 7 a.m. to 3 p.m. shift on September 21, 2000, B. B. was standing at the nurses' station and yelling at staff. He said, "I'm getting the hell out of here, they just can’t put me here and leave." He called his daughter and after hanging up, he became more agitated. Later in the morning, S. B. came to Haverhill to complete the admissions paperwork and to see her father. When she arrived B. B. was sitting on a bench outside the facility unsupervised. She took her father back inside the facility and went to find the admissions director so that she could complete the necessary paperwork. While she was completing the paperwork, she did not advise anyone that her father wandered or that he had eloped from Four Seasons. However, given the information that Kit Johnson had told Mr. Eason, he should have asked S. B. about any previous attempts by B. B. to leave home or other facilities and should have requested additional information from IHS West Palm Beach. According to the testimony at final hearing, by Monday, September 21, 1998, Mr. Eason claimed not to know that B. B. had been admitted on September 18 from IHS West Palm Beach. It can only be concluded that between Friday afternoon and Monday morning Mr. Eason had forgotten about B. B. After finishing the necessary admissions paperwork, S. B. went to her father's room to visit with him. When she was leaving the facility, her father thought that he was going to go with her and attempted to follow S. B. Haverhill staff had to intervene. B. B. became verbally and physically abusive, and the Administrator of Haverhill had to be called to assist. B. B. took a swing at the administrator. B. B. was taken back to his room, where he stayed. He told staff that they could not do anything for him and to leave his room. No one at staff notified S. B. of her father's episode. B. B.'s doctor was notified of B. B.'s behavior. The doctor prescribed anti-psychotic and anti-anxiety medications and ordered a psychological evaluation. Staff placed a call to the psychological services provider, requesting an evaluation. Both the Agency's and Haverhill's expert witnesses agreed that B. B.'s attempt to leave with his daughter was a catastrophic event, which is a clinical term used to describe a level of agitation of such sustained duration that it requires intervention by the caregiver. Haverhill did provide intervention by directing B. B. back to his room and informing the doctor. Haverhill had a policy and procedure to deal with residents who displayed mental difficulty. The policy and procedure provided: POLICY To protect the resident and other residents of the facility from harming themselves or others. To ensure that the resident receives appropriate treatment and services to correct the assessed problem. PROCEDURE When a resident exhibits behavior such as trying to elope, aggressive behavior, speaking of suicide or other behaviors relating to signs of distress or depression, nursing is to: calm resident close monitoring of resident call physician call family psychological services complete documentation of incident, and interventions and responses notify social services notify Director of Nursing Haverhill did not notify S. B. of the catastrophic event and did not closely monitor as called for in its policy and procedure. On September 22, 1998, Haverhill developed a care plan to deal with B. B.'s verbal and physical abuse to staff and residents. The care plan included the following: Redirect him when he becomes aggressive. Psy consult per MD order. Medicate per doctor order. Provide quiet area to promote conversations regarding his concerns. On September 22, 1998, B. B. continued to be noticeably anxious and angry and paced the floor. He made a telephone call, and after the call, he slammed his fist on the nurses' desk and expressed anger. He was redirected to his room. His new medication was begun at 9 a.m. By 1 p.m., B. B. was calmer, walking in the hallway to the nurses station and saying, "Hi" to staff when approached. Later in the day, B. B. became drowsy and slightly unsteady on his feet. He was redirected to his room. A care plan was developed to deal with the side effects of his new medications. No one arrived to do a psychological evaluation on B. B. on September 22, 1998. The provider was again called and asked to send someone. S. B. visited B. B. on September 23, 1998. B. B. told her that he was ready to go home. She left the facility around 3 or 4 o'clock in the afternoon. According to B. B.'s roommate, B. B. went to bed around 4 p.m. Around 5 p.m., B. B. was up and his gait was unsteady. The doctor was notified of the side effects of the new medications on September 23, 1998. The doctor ordered Haverhill to withhold B. B.'s scheduled dose of Ativan. As of 6:15 p.m. on September 23, no one had shown up to perform a psychological evaluation. No nurses' notes or social service progress notes indicate that anyone came on September 23 to perform a mental evaluation of B. B. The social services progress notes indicate that on September 23, B. B. was calm and had no behaviors during the day. B. B. asked for snacks around 8 p.m. The charge nurse who admitted him, stated that at 11 p.m., he was lying on his bed fully dressed. D. D., another resident in the building, stated that he saw B. B. up around 1:30 or 2:30 a.m. on September 24, wrapped in a blanket and asking if his daughter had been by to see him. B. B. went back to bed and got up between 3:00 and 3:30 a.m. to get coffee. He walked to the nurses station and was told by staff that it was too early and that he should go back to his room. B. B went back to bed. D. D. saw B. B. get up around 4:45 a.m. and get dressed. At 5:10 a.m., while doing bed checks, the nursing staff noted that B. B. was missing and began a search for him. He could not be found, leading to the conclusion that he had eloped. On November 2, 1998, B. B.'s body was found in a drainage ditch a quarter of a mile from the facility. On October 27, 1998, Haverhill received a report on B. B.'s mental status examination from the psychological services provider. The report was typed except for the signatures and the day on the date. The date of the interview was listed as 09/23/98 with the "23" handwritten. The Agency contends that Haverhill did not provide adequate supervision to B. B. because it did not have sufficient staff on hand when B. B. eloped from the facility on September 24, 1999. The Agency bases this contention on its interpretation of a staffing summary which was prepared by Haverhill that indicated that Haverhill did not have sufficient certified nursing assistant hours to meet minimum state standards on September 24. The summary indicates the number of certified nursing assistant and licensed nursing hours hired at Haverhill for each day between September 20 and 28, 1998. Each 24-hour period represented on the summary begins with the 7:00 a.m. shift on the designated day and runs until the 7:00 a.m. shift on the following day. Accordingly, the staffing levels reflected for September 24, 1998, would be those which began at 7:00 a.m. on that day and ran until 7:00 a.m. on September 25, 1998. B. B. eloped from Haverhill around 5:00 a.m. on September 24, 1998. Since his elopement occurred prior to 7:00 a.m. on September 24, the staffing levels reflected in the summary on September 23, 1998, would cover the time period during which B. B. eloped. On September 23, Haverhill exceeded minimum state requirements for certified nursing assistants by 46.8 hours and for licensed nurses by 40.1 hours. Although Haverhill identified a care plan for B. B. upon admission, Haverhill failed to implement the care plan. Specifically no one assisted in diverting B. B.'s focus on wanting to leave the facility. No evidence was provided that organized activities oriented to meet B. B.'s needs were provided. According to the Agency's expert, B. B.'s frequent ambulating in the halls, as documented in the nurses' notes, demonstrated his lack of participation in organized activities. The Agency charges Haverhill with a violation of 42 CFR Sections 483.35(c)(1) and (2) for failure to treat pressure sores on Residents 1 and 16. The deficiency was identified as Tag F314, determined to be a Class II deficiency, and determined to have a severity rating of "G." Resident 1 was a 75-year-old female admitted to Haverhill's facility on October 6, 1999. She was diagnosed with end-stage Alzheimer's disease. Prior to admission, she had a feeding tube inserted. Upon admission Resident 1 was self-ambulating, and the nurses' notes reflect that Resident was a wanderer and walked on a regular basis. She had no skin breakdown when admitted, but she was assessed at a high risk for pressure sores, due to bowel incontinence. A pressure sore is a lesion that is caused by unrelieved pressure to an area and results in damage to underlying tissue. A care plan was developed on October 6, 1999, to address Resident 1's risk for pressure sores. The care plan included the use of pressure relieving chairs and beds; turning and repositioning with no specific times listed; ulcer care; use of cleansing agent and water to clean skin whenever soiled, and treatment of dry skin with moisturizer. According to the physician's orders on October 6, 1999, Resident 1 was to have a skin assessment with showers weekly, and a skin barrier with lantiseptic ointment applied to her buttocks every shift or three times a day, and intermittently as needed. Another care plan was developed on October 26, 1999, after a comprehensive assessment had been completed. The October 26 care plan did not include turning and repositioning. The standard of care to prevent pressure sores from developing includes regular turning and repositioning every two hours, keeping the skin clean and dry, and adequate nutrition and hydration. When a resident is ambulatory and can move herself in bed, turning and repositioning is less of a factor. According to the nurses' notes for Resident 1, she slept most of the day on October 25, 1999, and continued to be drowsy on October 26. The doctor reduced her dosage of Haldol. Resident 1 was terminally ill and was placed on hospice service on October 27, 1999. On October 29, 1999, she was drowsy but alert and ambulatory. She was walking on October 31, 1999, with a slow, steady gait. On November 2, 1999, Resident 1 had no open sores. On November 8, 1999, the treatment notes indicate no open sores on Resident 1, but there was some redness in the perianal area, which was treated with a cream. On November 8, 1999, the nurses' notes indicate that Resident 1 was ambulating with some difficulty. She was kept clean and dry, and her skin was intact. On November 10, 1999, it was noted that she was alert and turning aimlessly in bed. On November 10, 1999, she showered, and the nurses notes indicated no areas of skin breakdown. On November 14, 1999, Resident 1 was ambulating and was able to turn self. On November 16, 1999, there were no open areas on Resident 1, but she developed hives all over her body. She was given Benedryl for the rash. On November 17, 1999, Resident slept most of the day. On November 23, 1999, there were no open areas on Resident 1. She was lethargic and was turned and repositioned. On November 24 and 25, 1999, Resident 1 remained lethargic and was turned and repositioned. On November 26, 1999, she was lethargic all day. She continued to be lethargic on November 27, 1999. She was kept clean and dry and was turned and repositioned. The nurses' notes indicate that on November 30 and December 3, 1999, Resident 1 continued to be lethargic. The nurses' notes indicate that she was turned and repositioned on December 3, 1999. On December 3, 1999, a nurse noted a pressure sore on Resident 1's coccyx, measuring .5 x .25 centimeters. The initial information regarding the treatment and identification of the pressure sore was documented on the treatment sheet of another patient with a similar name. The error was corrected on December 6, 1999. No evidence showed that the incorrect charting resulted in a failure to treat the pressure sore. The pressure sore was a stage II pressure sore, which means either a blister or a shallow open area in which only the epidermis is affected. The area was cleansed and duoderm was applied. Pressure sores are staged to standardize descriptions. Staging is not a means to describe a progression from one stage to the next. Sores can appear at any stage from a I to a IV. On December 5, 1999, the pressure sore was assessed. The skin was broken, and the area was red and dry. The area was cleaned, and duoderm was applied. Resident 1 was lethargic and unresponsive to verbal stimulus. She was turned and repositioned. During a survey on December 6, 1999, a surveyor from the Agency observed the pressure sore, and described it as a shallow crater over a bony prominence. The nurses' notes on December 6, 1999, at 6:00 a.m., 12:00 p.m., and 7 p.m. indicate that Resident 1 was turned and repositioned. On December 6, 1999, two surveyors from the agency were at Haverhill. According to one surveyor numerous staff went into Resident 1's room from 6:00 a.m. to 9:00 a.m., but when she went into the room Resident 1 did not appear to have been repositioned. However, the other surveyor said that no staff went into Resident 1's room during the same time period. Between 6:00 a.m. and 9:00 a.m. on December 6, 1999, Resident 1 was turned and repositioned. On December 7, 1999, cream was applied to Resident 1's buttock area, and she was turned and repositioned. She was repositioned on December 8 and 9, 1999. By December 10, 1999, the pressure sore had closed and was healing well. On December 17, 1999, it was noted that the pressure sore was healing well and was pink in color. The Agency had cited Haverhill for not adding zinc or vitamin C to Resident 1's nutrition after the pressure sore was noted on December 3, 1999. Haverhill's dietician evaluated Resident 1 on December 5, 1999, to determine whether additional nutrition was necessary. After a thorough review of the resident's condition and history, including Resident 1's husband's concerns, the dietician specifically considered the addition of supplements and concluded that Vitamin C and zinc might be added "if wound not responding to [treatment] x 2 wks." Standard guidelines suggest adding these supplements only for more serious wound concerns. Zinc and Vitamin C did not have to be added to Resident 1's nutrition. The agency alleged that Haverhill should have done a significant change assessment based on Resident 1's decreased physical capabilities that began in October 25, 1999, her bedfast condition since November 22, 1999, and her nutritional deficits since November 22, 2000. The federal guidelines concerning significant change in status assessments are contained in HCFA's RAI Version 2.0 Manual. The guidelines provide: A 'significant change' is defined as a major change in the resident's status that Is not self-limiting; Impacts on more than one area of the resident's health status; and Requires interdisciplinary review or revision of the care plan. A condition is defined as 'self- limiting' when the condition will normally resolve itself without further intervention or by staff implementing standard disease related clinical interventions. * * * The amount of time that would be appropriate for a facility to monitor a resident depends on the clinical situation and severity of symptoms experienced by the resident. Generally, if the condition has not resolved itself within approximately 2 weeks, staff should begin a comprehensive RAI assessment. This time frame is not meant to be prescriptive, but rather should be driven by clinical judgment and the resident's needs. * * * In an end stage disease status, a full reassessment is optional, depending on a clinical determination of whether the resident would benefit from it. The facility is still responsible for providing necessary care and services to assist the resident to achieve his or her highest practicable well- being. However, provided that the facility identifies and responds to problems and needs associated with the terminal condition, a comprehensive reassessment is not necessarily indicated. A significant change assessment was not done. Based on the federal guidelines, it was discretionary for Haverhill to do a significant change assessment because of Resident 1's terminal illness. There was no evidence to link the failure to complete a significant change assessment and the actual care given to Resident 1. Nurses' notes reflect that staff was very aware of Resident 1's condition and took measures to address it. There are frequent notes, which established discussions with the concerned husband, being turned and repositioned, being kept clean and dry, being fed, obtaining lab tests, and changing medications. Resident 1 did develop a pressure sore while at Haverhill, but the treatment and care that she was provided prior to the development of the pressure sore indicate that Haverhill did what it could to prevent the development of the pressure sore and that the development was unavoidable. After the pressure sore developed, Haverhill provided the necessary treatment to promote healing and prevent infection. Resident 16 was a 66-year-old, non-ambulatory female, who was admitted to Haverhill on August 4, 1999, from the hospital where she had undergone surgeries for both a pacemaker and a gastrostomy tube. She had an indwelling catheter and bowel incontinence. Resident 16 was totally dependent on staff for all activities of daily living. When she was admitted to Haverhill, Resident 16 had a stage II pressure sore on her left buttock. She was assessed as being a high risk for pressure sores. Her preliminary care plan developed on August 4, 1999, included turning and repositioning every two hours, weekly skin assessments, cleaning for incontinence, using barrier cream, and dressing the pressure sore as ordered. She was placed on a maxi-float mattress rather than a standard mattress. By August 11, the pressure sore was only pink and had completely healed by August 30, 1999. At 9:00 p.m. on August 20, 1999, it was noted that Resident 16 had a stage II, one centimeter-sized open area at her coccyx. The area was cleaned and dressed. The doctor was notified on August 21, 1999, about the pressure sore to the coccyx. He prescribed duoderm. It was also noted on August 21, 1999, that Resident 16's shoulder blades were red and scraped and needed to be monitored. Cream was applied to the shoulder blades. Resident 16 was kept in bed rather than a geri chair on August 22, 1999, so that she could be turned from side to side every two hours. Cream was applied to the shoulder blades, and the duoderm was intact to the coccyx. Haverhill's dietician described the pressure sore on the coccyx as a stage III, measuring 4.5 cm x 4.7 cm with 35 percent necrosis and 65 percent slough. On August 23, 1999, Resident 16 was sent to physical therapy for wound care, because the physical therapist had special training in this area. The physical therapist described the pressure sore area as having a hematoma and part of the wound being yellow and brown with inherent necrotic tissue. The pressure sore had no depth, the drainage was scant, and there was some breakthrough granulation. This description indicates that the wound was covered with possible necrotic tissue underneath. When the necrotic tissue was removed, such as the physical therapist did with mechanical debridement, an opening was revealed. After the wound was cleaned and debrided, it increased in size. On August 25 and 26, 1999, wound treatment was performed on the pressure sore area at the coccyx. The dietician notes indicate that the pressure sore continued to be a stage III on August 31, 1999, and measured 4.5 cm x 5 cm with 70 percent necrosis, 20 percent slough, and 10 percent granulation. Vitamin C and zinc support was ordered for Resident 16. On September 1, 1999, Resident 16 was placed on a different pressure reduction mattress. A wound culture was sent to the laboratory. By September 2, 1999, the wound had become infected. Antibiotics were administered beginning on September 3, 1999. Wound care treatment was also performed on September 3, 1999. On September 4, 1999, the dressing was changed to the pressure sore. The nurse noted that there was a dark circle on the inner side of the right heel. Heel protectors were put on Resident 16. Resident 16's care plan was revised on September 7, 1999, to change the turning and repositioning time to once every hour. On September 9, 1999, the nurse called the doctor regarding the pressure sore and requested that the wound care center be contacted for evaluation and treatment. A call was placed to the wound care center. On September 10, 1999, the wound care center called and stated they could not treat Resident 16 because of insurance coverage. The same day a call was placed to the hospital to see if Resident 16 could be treated there for wound care. On September 13, 1999, the hospital called and advised that Resident 16 could not be treated there because of insurance coverage. On September 14, 1999, Resident 16 was placed on an air mattress to help relieve the pressure. By September 16, 1999, according to the nurses' notes, the wound consisted of "much unhealthy and necrotic tissue with very foul odor and much purulent discharge." The dietician noted that the wound was still at a stage III. On September 17, 1999, the doctor ordered that Resident 16 be sent to the hospital emergency room for wound treatment and evaluation. At 1:00 p.m. on September 17, 1999, the nurses' notes indicate that complete care was given, including cleaning after an incontinent episode, dressing change, and turning. Resident 16 left for the emergency room by stretcher at 1:30 p.m. When she seen by the doctor at the hospital, he noted that the wound was contaminated with feces. Given the resident's incontinence, this is not an unexpected condition despite her having been cleaned just prior to leaving for the hospital. She could have had an incontinent episode on the way to the hospital or while waiting in the emergency room. No evidence was provided to establish that she was dirty when she left Haverhill. The doctors at the hospital described the pressure sore as a stage IV decubitus ulcer with a 12 to 14 centimeter diameter. The ulcer was grossly contaminated and would require cleaning over the next three to four days. Her laboratory tests showed that she also had a pseudomonas urinary tract infection. It was recommended that a diverting colostomy be considered for Resident 16 to keep "the fecal stream from continually bathing this area and giving rise to a chronic septic condition for the patient." Pseudomonas in the urine is indicative of contamination in the bladder. Such contamination could come from lying in the bed in stool or from improper cleaning related to Resident 16's indwelling catheter. In Resident 16's case, the stool was brought up around the catheter, which carried the bacteria to the bladder. Resident 16 was kept at the hospital from September 17 to September 25, 1999. Based on the dietician's notes, the pressure sore was a stage IV when Resident 16 returned from the hospital. On October 6, 1999, the resident's care plan was amended. On October 9, 1999, the pressure sore was still a stage IV and measured 4.0 x 5.0 x 2.2 cm with undermining. The nutritional assessment for November 15, 1999, showed that the pressure sore was a stage IV. On November 24, 1999, the pressure sore measured 2.8 x 2.2 x 1.5 cm with undermining. At the time of the Agency's survey on December 8, 1999, Resident 16's pressure sore on her coccyx was still a stage IV, and she had developed a pressure sore on her left heel. Turning and repositioning is important in preventing pressure sores. The standard nursing practice for turning and repositioning is a minimum of every two hours. Haverhill's policy for turning was every two hours. Resident 16's care plan showed that she was to be turned every two hours until September 7, 1999, when the care plan was amended to turning every hour. The standard nursing practice for charting records depends on the condition of the patient. Resident 16 should have been charted on every shift throughout the day, based on her high-risk status, her bedfast position, her existing pressure sore, the contractures of her lower extremities, and her medical history. Based on Haverhill's nursing notes, Resident 16 was turned and repositioned 656 times, or less than a third of the total number of times required, 2,320, by Resident 16's care plan between August 4 and December 7, 1999. Based on Haverhill's charting records, Resident 16 was turned and repositioned 356 times, or less than a sixth of the number of times required by the care plan between August 4 and December 7, 1999. Haverhill's records show that the number of times Resident 16 should have been turned and repositioned, consistent with Resident 16's care plan, was significantly higher than the actual number of times that Resident 16 was turned and repositioned. The Agency claims that Haverhill failed to do skin assessments according to physicians orders during the month of September, 1999. The physician ordered a skin assessment once a week with showers. The assessments were done according to the doctor's orders. During part of September, Resident 16 was in the hospital for wound treatment; therefore, Haverhill could not have done a skin assessment at that time. When Resident 16 returned from the hospital there were only five days left in the month; thus, another skin assessment was not due to be conducted in September. Haverhill failed to turn and reposition Resident 16 as required by her care plan. Resident did develop a pressure sore, which was not unavoidable. Haverhill did not provide treatment that would promote healing of the pressure sore due to Haverhill's failure to turn and reposition Resident 16 as required by her care plan.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing Counts VIII and IX of the Administrative Complaint, upholding the conditional license for Petitioner effective October 14, 1998, through January 3, 1999, and December 8, 1999, through February 9, 2000. DONE AND ENTERED this 8th day of November, 2000, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of November, 2000. COPIES FURNISHED: R. Davis Thomas, Jr. Qualified Representative Donna H. Stinson, Esquire 215 South Monroe Street Suite 400 Tallahassee, Florida 32302 Tracy S. Cottle, Esquire Agency for Health Care Administration Regional Service Center Fort Knox Building 3, Suite 3231 2727 Mahan Drive Tallahassee, Florida 32308 Sam Power, Agency Clerk 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
The Issue Whether there is need for a new 60-bed general acute care hospital in Seminole County? If so, to which of two applicants should a CON be awarded to construct and operate the hospital: Orlando Regional Healthcare System, Inc. (CON 9496), or Adventist Health System/Sunbelt, Inc., d/b/a Florida Hospital (CON 9497)?
Findings Of Fact The Battleground: District 7 At the heart of the conflict in this proceeding is that the two corporate combatants are the dominant providers of hospital services in major metropolitan Orlando and both are providers of very high quality acute care hospital services. Each seeks authority to construct and operate a 60-bed general acute care hospital in the fast-growing community of Oviedo, Florida. The Agency for Health Care Administration, arbiter of the conflict, has introduced a quarrel of its own by its determination that there is no need for the hospital in Oviedo, a determination with which the hospitals decidedly take issue. Oviedo is an incorporated area in east Seminole County. Seminole County, in turn, is a county that with two other counties makes a contribution by suburb or city center to the conurbation in and around Orlando, Florida's largest non-coastal city. Seminole County is also one of four counties that comprise District 7, one of eleven health service planning districts into which the Legislature has partitioned the state. See Section 408.032(5), Florida Statutes. The other three counties in the District are Orange, Osceola and, removed from the controversy in this case, Brevard. The four counties are each considered by rule of AHCA to constitute a sub-district of District 7. Brevard is Sub-district 1; Orange, sub-district 2; Seminole, sub-district 3; and, Osceola, sub-district 4. The parties consider parts of Seminole and Osceola Counties to constitute the major metropolitan area of the City of Orlando together with, of course, parts of Orange County, the county that contains incorporated Orlando. As indicated above and by its irrelevance to this proceeding, no part of Brevard County is considered by the parties to make up any of metropolitan Orlando. There is also one county outside District 7 about which the parties introduced evidence, Lake County in District 3. Nonetheless, District 7 remains the primary battleground with a focus on sub-district 3 as the site of the CON sought by the parties. The Parties AHCA The Agency for Health Care Administration is the state agency responsible for the administration of the CON program in Florida pursuant to the Health Facility and Services Development Act, Sections 408.031-408.045, Florida Statutes. ORHS One of the two dominant health care providers in the Orlando area, Orlando Regional Healthcare System, Inc., is a Florida not-for-profit corporation that owns and operates eight facilities in the four-county area of Orange, Seminole, Osceola and Lake Counties, "the only market" (tr. 22) that it serves. Half of ORHS's facilities are in Orange County. These four facilities are: Orlando Regional Medical Center, a 517-bed general acute care hospital that provides tertiary services in addition to routine acute care hospital services and that is the site of a trauma center; Arnold Palmer Hospital for Children and Women, a 281-bed specialty hospital that provides women's and children's services including neonatal services; Orlando Regional Sand Lake Hospital, a 153-bed general acute care facility that provides comprehensive medical rehabilitation services; and Orlando Regional Lucerne Hospital, a 267-bed general acute care hospital that provides comprehensive medical rehabilitation and skilled nursing unit services. In Seminole County, ORHS wholly owns and operates Orlando Regional South Seminole Hospital ("South Seminole"), a 206-bed general acute care facility that provides adult/child psychiatric and adult substance abuse services as well as general acute care services. In Osceola County, ORHS owns Orlando Regional St. Cloud Hospital, an 84-bed general acute care facility. In Lake County, ORHS jointly owns and operates two health care facilities under joint venture business arrangements: South Lake Hospital, a 68-bed general acute care facility and Leesburg Regional Medical Center, a 294-bed general acute care facility. The wholly owned facilities operate under a single license and are accredited by the Joint Commission on Accreditation of Health Care Organizations ("JCAHO"). One of six statutory teaching hospitals in the state, ORHS has been in continuous existence since 1918. Its mission is to be a local, unaffiliated health care provider, providing health care services to the citizens of Central Florida. Recognized as one of the top 100 hospitals in the United States by US News and World Report, ORHS has been the recipient of numerous awards and recognitions. As but one example, it was the winner of a Consumer Choice Award from the National Research Corporation for the years 1999 through 2001. Orlando Regional Healthcare System provides outstanding health care of the highest quality to patients at its eight facilities in three of the four counties in AHCA's Health Care Planning District 7. Florida Hospital The other dominant health care provider in the Orlando area is Florida Hospital. Founded as a sanitarium, Florida Hospital has been in existence and a presence in the Orlando medical community since 1908. Florida Hospital is part of the Adventist Health System, a not-for-profit hospital organization that operates hospitals throughout the country. In the Orlando area, Florida Hospital has seven acute care campus systems operated under a single license in a three- county area: Orange, Seminole and Osceola Counties. The original and main campus is located in downtown Orlando. A second campus is in East Orlando. The five other facilities are in Altamonte Springs, to the northwest of Orlando; Apopka, further northwest; Winter Park, just north of Orlando; and Celebration and Kissimmee, both southwest of the city. Florida Hospital also operates Florida Hospital Waterman under a separate license in Lake County in District 3. The seven campuses in District 7 are unified by more than just licensure. Consistent with their operation under a single license, all seven operate under a single provider number with Medicare/Medicaid. They have a single medical staff and a single accreditation with JCAHO. The seven Florida Hospital campuses operate under a single leadership structure; all policies, procedures and matters that pertain to the operation of the hospital are part of the single body of operational guidelines and procedures that are provided by the organization. The seven campuses also operate under a single price structure, a single charge master that runs across the entire organization. The goal of operating the seven campuses in a unified manner is to maintain continuity and promote one standard of care so that when a patient enters any of the facilities, the patient can rely on receiving the same high standard of care as would be received at any other Florida Hospital facility. Operation under a single structure also provides a patient with the coverage of physicians and staff throughout the system to cover any and all needs of the patient. From its inception, the mission of Florida Hospital has been to extend a religious ministry of healing to the community consistent with Adventist principles. Among these principles are awareness of the eternal nature of the moment at which care is extended to the patient as well as recognition of each patient as a child of God, entitled to the highest possible quality of care embodied in "whole person health" (tr. 876) composed of physical, mental and spiritual well-being. Florida Hospital carries out its mission with "a strong sense of stewardship for providing care in the communities that [the hospital] serve[s] . . . ." (Tr. 875). The success of Florida Hospital's philosophy of care is evident in recognition bestowed by others. For example, Florida Hospital was recognized as being among the top 50 hospitals in the country for nine specialties in the July 2002 edition of U.S. News & World Report's "America's Best Hospitals." To take but one of the nine, "Heart & Heart Surgery," Florida Hospital is ranked 12th in the nation in the company of those ranked just above: Cleveland Clinic, Mayo Clinic (Rochester), Massachusetts General, Brigham and Women's Hospital, Duke University Medical Center, Johns Hopkins, Texas Heart Institute-St. Luke's in Houston, Emory University Hospital, Stanford University Hospital, Barnes-Jewish Hospital in St. Louis and the UCLA Medical Center. Well-Matched Applicants In its state agency action report ("SAAR"), AHCA noted that ORHS and Florida Hospital are two large, well-matched hospital systems. Both operate over 1,500 beds in the Orlando area. Both generate approximately two billion dollars of gross charges annually. Both deliver over 300,000 patient days of patient care. Together, they are the overwhelmingly dominant providers of health care in the major metropolitan Orlando area. In the SAAR, the Agency discussed distinctions between the two applicants. Had AHCA determined that there was need for the facility, it would have had a difficult time deciding which corporation should be awarded the CON. None of the distinctions between the two were found by AHCA to be substantial enough to serve as a basis for choosing either applicant over the other. Other District 7 Hospitals Besides the two applicants, the dominant providers of hospital services in District 7 by virtue of number of facilities (13 hospitals in the District and three hospitals in Lake County immediately adjacent to the District), among other reasons, there are three other hospitals in the District. Health Central is a hospital operated by a statutorily created tax district in the City of Ocoee, in Orange County. Central Florida Regional Hospital is owned and operated by Hospital Corporation of America ("HCA") located in the City of Sanford in Seminole County. It is approximately 14 miles from the proposed locations of the applicant's facilities. Osceola Regional Medical Center, another HCA facility, is located in Kissimmee in Osceola County, not far from Florida Hospital's Kissimmee and Celebration facilities. Stipulation The parties stipulated to the following: The applicable fixed-need is zero. Both applications complied with the requirements of Sections 408.037, 408.038 and Subsections (1), (2) and (3) of Section 408.039, Florida Statutes, and the requirements of Rules 59C-1.008 and 59C-1.010, Florida Administrative Code. Both applications meet the review criteria contained in Subsections 408.035 (3),(6),(8),(10) and (11), Florida Statutes and the review criteria in Subsections 408.035(4),(5) and (12), Florida Statutes, are not applicable in this case. The statutory review criteria at issue in this case are Subsections 408.035(1), (2), (7) and (9), Florida Statutes. Numeric Need Numeric need for general acute care beds is determined pursuant to Agency rule, Rule 59C-1.038, Florida Administrative Code. The rule's methodology for the calculation of numeric need for general acute care beds is by sub-district. Since "there really is no longer a future projection methodology in the rule . . . it was stricken out two or three years ago," Gene Nelson, one of ORHS' experts in health planning, refers to the rule as containing a "retrospective occupancy model." (Tr. 619). Under the methodology, additional beds are not normally approved in any sub-district where historic occupancy is less than 75%. If occupancy exceeds 75%, beds will be awarded to bring occupancy down to 75%. In other words, instead of projecting forward as it once did to determine need, the rule looks back to occupancy. If occupancy in the sub- district has met the threshold, then positive numeric need is established. Criticism has been leveled at the methodology. Not taking into account future population growth or occupancy rates at times other than midnight, are but two examples. Criticism, however, of the rule is of little moment in this case since the case is a challenge to agency action not to the rule that contains the methodology. Whatever the appropriateness or validity of the criticism, the calculations pursuant to the methodology have not yielded a fixed-need pool above zero for any of the many sub- districts in the eleven districts of the state for some years now. Nor is numeric need for general acute care beds expected by the Agency to exceed zero anywhere in the state for the foreseeable future. During this time of numeric need "drought," AHCA, nonetheless has awarded CONs for new general acute care beds and even new hospitals on a number of occasions. For example, "[d]espite the fact that there was an applicant proposing to relocate beds within the subdistrict, which wouldn't have affected the bed inventory at all, the state elected to approve [another] applicant . . . that applied for a brand-new 60 bed hospital" (tr. 635) in the community of Lady Lake in District 3. The application in that instance had been filed in the fall of 1998. In a second example, in the fall of 2001, a few years later, Osceola Regional and Florida Hospital Celebration were each approved to add beds to existing facilities despite the fact that there was no numeric need and the hospitals did not meet the statutory occupancy levels for additional beds. Mr. Nelson also testified about a third recent example where a new hospital was built when the subdistrict occupancy was low, the facts of which compare favorably, in his view, with the facts in this case. As he tells it, these three cases, compared to this case, produce inconsistency: In the fall of 1999, Sacred Heart Hospital applied to build a new 60-bed hospital in the southern portion of Walton County. That particular subdistrict is actually a two-county subdistrict consisting of Okaloosa and Walton counties, has some existing hospitals, current subdistrict occupancy in that area is 56.3 percent. Despite . . . the low occupancy . . . the state recognized the validity of the arguments about a growing population, about accessibility, many of the same issues that you have here and approved Sacred Heart to build a new 60-bed hospital in that location. * * * I am not criticizing any of these approvals. I . . . am criticizing [that the state was] presented with a similar set of circumstances in this case [and] the applications were all denied. And I think there is an inconsistency here. (Tr. 637-8). During the same period, moreover, beds have been added to existing hospitals without CON review, accomplished by way of Section 408.036(n), Florida Statutes. The statute allows 10 beds or 10% of licensed bed capacity to be added to a hospital's acute bed inventory upon certification "that the prior 12-month average occupancy rate for the category of licensed beds being expanded at the facility meets or exceeds 80% . . . ." Section 408.036(n)(1)a., Florida Statutes. See also Rule 59C-1.038(5), Florida Administrative Code. The bed additions made with and without CON review contribute to current numeric need determinations of "zero" and the continued reasonable expectation that AHCA's methodology for determining acute care bed numeric need will not yield numeric need in excess of zero for years to come. Most pertinently to this case, these additions erode AHCA's position advanced in hearing in this case for a preference to keep open the option for a future competitor, a competitor other than one of the two dominant providers, presumably when numeric need has been determined to exist, a condition not likely to come into play for the foreseeable future. However the future plays itself out and the effect on AHCA's current methodology, there remains one point central to consideration in this case. In light of a numeric need of "zero" for the applicable batching cycle, for a CON to be awarded as a result of this proceeding, as a first step, the applicants must demonstrate the existence of "not normal" circumstances that support an award. The two applicants attempt that step in tandem. Both ORHS and Florida Hospital contend that rapid population growth, problems of access to acute care and emergency services in the Oveido area, and mal-distribution of beds in the sub-district and district constitute circumstances that justify need for their proposed facilities. In other words, they are "not normal" circumstances. Not Normal Circumstances - Population Growth A rural farm community not long ago with a population of about 7,500, the City of Oviedo, in the last 15 years, has grown into an Orlando bedroom community. The population increase within the city limits is proof of the city's metamorphosis from countryside to suburb. During this period of time, the municipal population has nearly quadrupled to 28,000 with no end in sight to continued growth in the area as explained by ORHS' expert, Dr. Rond: The special circumstances . . . that drive this application are, first, the unprecedented population growth. As we have seen, we are experiencing population growth in excess of a hundred percent in the east Seminole area. In the adjacent Winter Springs area, we are experiencing a rate in excess of 51 percent. We are talking about a population that is going to reach almost 200,000 people by the year 2006. (Tr. 377-8). The area is projected for an additional 18.2% growth by 2006, when as testified to by Dr. Rond, the population will reach nearly 200,000. The municipal population is not the only population of a political entity in the area to quadruple in modern memory. Over the past three decades Seminole County has grown fourfold - from 83,692 in 1970 to 365,196 in 2000. As a result, the county is the third most densely populated of the state's 67 counties. Until the mid-1990's, population growth was concentrated in the western half of the county as Orlando area development spread north into Seminole County along the I-4 and U.S. Highway 17/92 corridors. Since then the rate of population growth has been dramatic in east Seminole County in part because of the opening of another major transportation corridor, the "Greenway," Highway 417. Between 1990 and 2001, east Seminole County more than doubled in size (24,840 to 51,287; a 107% increase) while West Seminole grew by only 22%. East Seminole County is expected to remain the fastest growing portion of the county into the foreseeable future. With approximately 43% of the total land area of the county but only about 16% of the population, it remains much less densely populated than the remainder of the county, affording greater opportunities for future growth. Seminole County is unique in the state from the perspective of bed-to-population ratios. The three hospitals in Seminole County with a combined total of 575 licensed beds, yield a ratio of 1.55 beds per 1,000 population; tied for lowest bed to population ratio of the sub-districts in the state. The only area with a comparable ratio is Sub-district 8-4, comprised of Glades and Hendry Counties, located southwest of Lake Okeechobee, "a very rural area." (Tr. 625). While these two sub-districts are similar in bed to population ratio, they are at opposite extremes in terms of population density. The population of Seminole County, at 371,000 is nearly nine times the combined populations of Glades and Hendry Counties at slightly more than 42,000. Sub-district 8-4 is "totally unlike Seminole County from the standpoint of population demographics; and yet in terms of resource availability, . . . it has a comparable amount of resources per thousand population." (Id.) Thus, Seminole County occupies a unique place in the state for its low bed-to- population ratio considering its overall population. Population forecasts for the next five-year period support the expectation of continued strong growth in east Seminole County. For example, the downtown area of Oviedo plans a residential area with a density up to 50 dwellings per acre, at least one of the highest in the County. In the City of Oviedo vicinity, median densities are increasing from 4 homes per acre to 10, to allow for townhouses. East Seminole County is reasonably expected to have 60,597 residents by the year 2006, an 18.2% increase over 2001. By comparison, West Seminole County is expected to experience only a 6.3% rate of growth. Projected growth in the City of Oviedo, moreover, is in all likelihood understated due to significant residential developments currently underway that alone are expected to add up to 6,238 new residents to the city's population. One need only look to actual growth in the area for support for such a prediction. Actual growth has consistently outpaced projected growth governed by methodologies that have repeatedly failed to reflect the reality of population growth in Oviedo. Related to population growth are utilization projections by the applicants' health planning experts for an Oviedo hospital. Judy Horowitz, Florida Hospital's expert health care planner, explained Florida Hospital's: [W]e looked at historically what had come out of the service area as we defined it. We projected that that volume would grow in proportion to population growth. We looked at a subset of services, those that were likely to be provided at a community hospital as was being proposed by Florida Hospital Oviedo. We looked at what we thought a reasonable market share would be; and our overall forecast is that within two years of opening this facility, that we would reach 77 percent occupancy at a 60-bed facility. So our year two, which is the 12 months ending June of 2007, . . . . we would already be at 77 percent occupancy. Then our first year we would be at approximately 68 percent occupancy. * * * [T]here is clearly sufficient demand to support the hospital as proposed; and the fact that we are projecting a relatively high utilization very quickly shows the magnitude of that demand. (Tr. 1352, 1353). With the high level of population growth and the demand for hospital services that such growth generates, the citizens of Oviedo expect access to hospital care within the community. In keeping with citizen expectation, the City of Oviedo has adopted a resolution that urges AHCA to approve a new hospital in the Oviedo community. It has been joined in its resolve by the Board of County Commissioners for Seminole County through a resolution of its own. To underscore the force of the two resolutions, the corporate parties presented the testimony of representatives of both the City Council and the County Commission. Grant Malloy, the County Commissioner for County District I who grew up in the area with fond childhood memories of "being overcome by the orange blossom smells, they were so intense," (tr. 802) described the growth observed first-hand by him during his lifetime as "phenomenal." (Tr. 806). In answer to the question whether his constituents would benefit by a new 60-bed hospital, Commissioner Malloy testified I do believe so. There is . . . the growth that's occurring there. And I heard . . . discussion about getting to some of the other hospitals. And once you get out of Seminole County . . . the roads are very, very difficult to travel on especially getting into Orlando. Especially rush hour . . . . . . . [T]he growth . . . would support such a facility. I know our board passed a resolution, along with the City of Oviedo[.] [O]ur board, and all the commissioners are unanimously supportive of a hospital in the area. I haven't heard from any residents or constituents that have said it was a bad idea. . . . [P]eople are pretty excited about it. (Tr. 807-8). Tom O'Hanlon, Chairman of the City Council, in the company of three other members of the council, unequivocally backed up Commissioner Malloy's appeal for a new hospital. The changes he has seen in Oviedo, he described as: Dramatic changes. When I moved there, [Oviedo] was a very rural area, and it is no longer . . .; it’s a highly compacted urban area. [W]e are working on a new master plan for downtown, which will have higher densities than we have in our city today. (Tr. 812). Chairman O'Hanlon went on to describe how the pace of the growth continuously outstrips population projections that are the product of the City's best efforts to follow appropriate methodologies for making such projections: [T]he city continually makes population projections. I have always been involved with them[.] [T]here are guidelines . . .; and everytime we make them, the city grows far in excess of th[e] projections. The area is such a dynamic area because we have got the University of Central Florida there, which is just growing as fast as the city is, maybe even faster. You have the Research Park there and you have got excellent schools. And for that combination . . . everybody wants to move there. (Tr. 812-3). The university is just south of the city limits. It has minimal dormitory facilities on campus. The result is that "a vast majority [of students] live off campus in housing and apartments [and they are impacting all the services that must be provided in Oviedo.]" (Tr. 814). Following this testimony of Chairman O'Hanlon, the following colloquy ensued between him and counsel for ORHS: Q Is it fair to say, Councilman O'Hanlon, that the City of Oviedo and surrounding area is in growing urban area that has everything but a hospital? A That is a true statement. Q Are you familiar, Councilman O'Hanlon, with the proposals of Orlando Regional Healthcare System and Florida Hospital to locate a 60-bed hospital in the City of Oviedo? A Yes. Q Do you support that effort? A A hundred percent. Q Do you believe, Councilman O'Hanlon, it would be of benefit to your constituents to have that [hospital] in the city of Oviedo? A Absolutely. People approach me every week wanting to know where our hospital is. Q Can't understand why it's not there already?A Well what they understand is that there is a tremendous need for a hospital and they don't understand why it's not in the process. (Tr 816-7). Residents of Oviedo also do not understand why they have to drive for such a long time to reach a hospital particularly when their goal is the emergency department. This concern about which Councilman O'Hanlon hears from a constituent "at least once a month" (tr. 819) also made its way into the resolutions of the two political bodies in the form of an identical introductory clause, as follows: "WHEREAS, there are increasing problems with timely access to care especially for emergencies," (Joint ORHS/Florida Hospital Nos. 8 and 10). It is, moreover, a concern that takes up the second prong of the applicants' case for "not normal" circumstances: issues of access. - Access The Oviedo Service Area Although similarities exist between the two, the Oviedo Service Areas defined by the two applicants are somewhat different. The service area selected by ORHS is larger than the service area selected by Florida Hospital. The Primary Service Area ("PSA") for ORHS' proposed hospital is composed of four zip codes: 32765, 32732, 32766, and 32708. Of the four, the first three are in eastern Seminole County, that is, east of Highway 417, the Greenway, and south of Lake Jessup. The fourth, 32708 in the Winter Springs area, is just west of the Greenway. The Winter Springs zip code was included in ORHS' PSA in part because it is adjacent to the Greenway. It has also experienced tremendous population growth and is very close to the proposed site for ORHS' hospital. A secondary service area proposed by ORHS is composed of a zip code in Seminole County north of Lake Jessup, 32773, and three zip codes in Orange County, 32817, 32820, and 32826. Located in the midst of the three Orange County zip codes is zip code 32816. It appears on ORHS exhibits as part of the secondary service area. As the zip code for the University of Central Florida, it has a very low residential population so that there are only a few students who might live in a dorm that would list it as their residence when receiving hospital services. There are actually "very few" (tr. 302) discharges from zip code 32816. If one does not include zip code 32816 then ORHS' service area is a comprised of eight zip codes. The April 1, 2001, population for the primary and secondary service areas or the service area designated by ORHS is 170,774. This service area has more than doubled in population over the last decade. Over the next five years, the service area is expected to reach 193,408 residents, of which 45% will be of prime child bearing age (15-44), "a dominant position for that age cohort within the population." (Tr. 315). The Oviedo service area is defined by Florida Hospital as four zip codes in Seminole County, 32708, 32732, 32765, and 32766 and one in Orange County: 32826 (all zip codes in ORHS' service area) with a population of more than 100,000. Florida Hospital's service area does not include Zip Code 32773 (the zip code north of Lake Jessup) that is in ORHS' service area nor, with the exception of 32826, does it include any of the Orange County zip codes that are in ORHS' service area. Thus, there are five zip codes in what Florida Hospital regards as the Oviedo Service Area and eight in what ORHS regards as the Oviedo Service Area if zip code 32816 is excluded. Although somewhat different, for purposes of examining travel distance and time between Oviedo and area hospitals, the Oviedo Service Areas of the two applicants are similar enough to be considered to be the same. Or, as William E. Tipton, an expert in traffic transportation and civil engineering, testified at hearing, the results of his study entitled "Travel Time Analysis Proposed ORHS Oviedo Campus, Oviedo, Florida" (ORHS Ex. 14) would not be substantially different if he had focused on the Florida Hospital site instead of the ORHS site. Travel Time Analysis Mr. Tipton prepared a travel time analysis to evaluate the differences in travel time that could be anticipated with the development of a hospital campus in Oviedo. Mr. Tipton's study concluded that there would be a reduction of average daily travel time from the ORHS PSA to a hospital by 64% or 18 minutes. The maximum reduction will be 75% of the time or 21 minutes. In the critical peak afternoon hour, there will be a maximum reduction of 79% or 22 minutes in time from that which exists today. The reductions in drive distance for Oviedo area residents if a hospital were in Oviedo would be significant especially in the arena of emergency services. Emergency Services Access to emergency services at a hospital emergency department ("ED") is one of the most important factors in making sure people have reasonable access to community hospitals. "[Y]ou really need . . . immediate care for emergencies, and so it's important to be able to get to the emergency department quickly and to receive care rapidly once you get there." (Tr. 336). Between 1997 and 2001, the hospitals experiencing the highest percentage of ED visit increase, other than Health Central, were Florida Hospital East in Orange County and South Seminole Hospital in Seminole County. During the period between 1997 and 2001, although the population of Seminole County grew less than Orange County, Seminole County had a larger percentage of ED visits. Specifically, the population of Seminole County grew 12% but its ED visits increased 23%, twice its population growth. During the same period, the population of Orange County grew by 15% but its ED visits only increased by 17%. Closer examination of these statistics reveals that ED visits in the downtown area of Orlando, to include Orlando Regional Medical Center and Florida Hospital, were below the county average. However, suburban hospitals, or those in outlying areas, particularly near Oviedo, had much greater ED visit growth: ED visits grew 27% at Florida Hospital Apopka and 37% at Florida Hospital East. Florida Hospital East is the closest hospital in Orange County to the Oviedo area. Of the hospitals in Seminole County, South Seminole was the most severely affected by ED visit increase with a 38% increase of ED visits between 1997 and 2001. (ED visits in excess of 27,000 by area residents are projected in 2006.) In the Oviedo area there are unfortunate but not uncommon delays in emergency transport. More than 20% of emergency transports involve delays of in excess of 45 minutes after arrival at the hospital. These delays are serious because patient outcomes decline dramatically if definitive care is not delivered within the "golden hour," a concept that: reflects the fact that patient outcomes decline [dra]matically in terms of . . . mortality rates if definitive care is not delivered within one hour of the traumatic injury that has been sustained. In cardiology, they tend to . . . say "time is muscle," * * * the longer it takes for a patient to get definitive care following a major cardiovascular event, the more muscle mass is likely to be damaged. . . . [Y]ou can go on and talk about stroke victims, cerebral vascular patients and just a whole array of patients who [fare] much better in terms of morbidity and mortality if they receive definitive care within an hour of the episode. (Tr. 336). Part of the delay for patients in need of prompt emergency services is due to ambulance standing time. Standing time is the time a patient waits in the ambulance or hallway of the emergency department before the patient is seen by medical staff. This standing time does not include the time it takes the ambulance to respond to the call or the time the EMS personnel spend at the scene to stabilize the patient. Nor does it include the travel time to the hospital from the scene. Ambulance standing time for patients from the Oviedo area on average is between 42 and 47 minutes. When average travel times established in Mr. Tipton's study are combined with the standing times, there is not one existing provider of emergency services that can provide a patient from Florida Hospital's Oviedo Service Area or ORHS' PSA with emergency care within the "golden hour." This combination, moreover, as stated above, does not take into account the dispatch time and time of the ambulance at the scene. The typical types of emergency calls EMS personnel see in Oviedo include difficulty breathing, auto accidents, kids falling off bicycles, heart attacks, and drug overdoses. The largest majority of calls would go to a local community hospital as opposed to trauma center in downtown Orlando. Jeffrey M. Gregg, Chief of the Bureau of Health Facility Regulation, which includes the Certificate of Need Program for the Agency for Health Care Administration, testified that emergency room access is a problem that has gotten worse over time. Mr. Gregg also stated that a new hospital in the area will improve emergency access for people in the immediate area. A new hospital in Oviedo service area would also benefit and improve emergency access for patients in Orange County emergency rooms by lessening the emergency patient loads they experience. Wayne Martin, Fire Chief, Emergency Management Director, City of Oviedo, testified that the standing times and delays at the area hospital emergency rooms tie up Oviedo area ambulance services for an extended period of time. Emergency Medical Service ("EMS") staff must stay with their patient until the patient is taken into the emergency room and given medical care by emergency department staff. Because of these delays, EMS staff are out of their service area for extended periods of time. This decreases the level of service for the residents of the Oviedo area. One aspect of the problem influences another so as to create a compounding effect. Dr. Robert A. Schamberger, a family practitioner in Oviedo, testified that recently a patient went to the emergency room at an area hospital and it took 16 hours from the times she arrived until she was seen by the emergency room personnel. Dr. Schamberger tried to admit another patient of his in an area hospital on a recent Friday and was informed there were no beds. The hospital said they would call when they had an available bed. The patient was finally admitted on Monday. Emergency room waiting times across the entire community are several hours, which is an unacceptable care standard. Dr. Zulma Cintron practices internal medicine in Oviedo. Dr. Cintron testified that there is a "huge need" for a hospital in the Oviedo area. "We definitely need the beds." Dr. Cintron has had patients with chest pains who ended up waiting in the emergency room for four, five, and six hours before receiving care. Patients with less imminent needs have waited 12, 16 even 24 hours. Dr. Cintron's testimony for Florida Hospital was confirmed by the testimony produced by ORHS of Scott Greenwood, M.D., a cardiologist who heads a cardiology group. The evidence provided by Drs. Schamberger, Cintron And Greenwood, anecdotal though it may be, supports the existence of a problem with emergency services access in the Oviedo area that is shown by the analysis provided by the combination of Mr. Tipton's traffic study and ambulance standing time. So does projected volume for ED visits. Projected volume at Florida Hospital Oviedo in year two would be in excess of 27,000 visits. The Oviedo area has a population that "is adequate to support a hospital at high utilization levels within [a] short period of time and also will generate a significant number of emergency visits." (Tr. 1355). A new hospital facility in the Oviedo service area would help to alleviate the delays currently being experienced in the area hospital emergency departments. The Agency is not unaware of the problem and the solution that an Oviedo hospital would provide. The issue for AHCA is "[w]ould the improvement that would result for some people justify the construction of an new hospital?" (Tr. 726). The applicants claim that the three existing Seminole County hospitals are not appropriately located to provide emergency services required by the growing population of Oviedo. Put another way, within the sub-district and District 7, ORHS and Florida Hospital assert there is a mal-distribution of beds. Mal-distribution of Beds While population growth has increased dramatically in east Seminole the opening of health care facilities in the east part of the county has lagged behind; the area has more than 100,000 people but no hospital. The three acute care hospitals in Subdistrict 7-4 are all located in the western portion of Seminole County. People tend to use hospitals closest to them especially for emergency services. Because of the north/south nature of the road corridors in Seminole County and the congestion and distances involved in east/west travel in the county, the Oviedo area population's access to existing hospital service in the district is problematic. The population has better access to resources in Orange County, a different subdistrict, and, in fact, 66% of the Oviedo population take advantage of that better access. Consistent with the pattern of transportation development in Seminole County, all three hospitals in Seminole County are located between I-4 and U.S. Highway 17-92. Florida Hospital Altamonte is situated along the 436 corridor, whereas South Seminole Hospital is located further to the north on State Road 434, while Central Florida Regional Hospital is situated at the northern border of the county along the U.S. Highway 17-92 corridor. Dr. Rond had this to say about the locations of the three Seminole County hospitals in relation to the population in east Seminole County: The resources in the western part of the county are not situated in such a way that they are being utilized effectively by residents of [ORHS'] service area. Instead, they seek to move along the north/south corridor, primarily the Greenway, to utilize the services located in Orange County or … they take other routes of access to reach Winter Park Hospital, which is . . . in Orange County. (Tr. 319). The problem of distribution of hospitals is not restricted simply to inside the county. There is a mal- distribution in District 7 as well. Overall in the district, there are 2.3 beds per thousand. Orange County enjoys a ratio that is very high when compared to Seminole County's. Orange County's bed to population ratio is 2.7 beds per thousand, whereas Seminole County's is only 1.55 beds per thousand. The average bed ratio in Florida is 2.85 per thousand. Whether measured against the state ratio or the Orange County ratio, general acute care hospital beds per thousand population in Seminole County is low. The ratio comparison between Orange County and Seminole County will improve with an Oviedo Hospital although it makes the overall ratio only "a little closer; so that Orange County has beds per thousand and Seminole County would have 1.6 beds per thousand." (Tr. 316). The applicants intend to make that improvement with their proposed projects. The Proposed Projects ORHS' Orlando Regional proposes to construct a new 60-bed acute care hospital in the City of Oviedo. The location was described at hearing by Karl W. Hodges, ORHS vice president of Business Development: [T]he hospital [will be built] within a two- mile radius of . . . Highway 426, also called Loma and Mitchell Hammock Road which is also called Red Bug Road. [The CON Application] further stipulates we'll be east of 417. (Tr. 20). Within that area, ORHS proposes to build a three-story 155,000 square foot facility on approximately 35 acres of land. Although a site has not yet been purchased, there is at least one parcel of 35 acres of land available in the area that can be acquired by ORHS at a price of $7,000,000 or less, as indicated in its application. The bed complement of the proposed facility will be eight ICU beds, ten labor-delivery-recovery and post-partum ("LDRP") beds serving the obstetrics department, 15 telemetry monitored beds, and 27 medical/surgical acute care beds. The proposal will add 30 beds to the inventory of beds in the sub-district but it will not add beds to the inventory of District 7. The 60 beds will be transferred by ORHS from two facilities. Thirty of the beds will come from South Seminole Hospital (in Seminole County). By itself, moving the 30 beds within the sub-district "for the stated goal of enhancing access . . . is a non-controversial project" (tr. 627) that is not subject to a certificate of need methodology but that still requires CON review and approval. The other thirty beds will come from Orlando Regional Lucerne Hospital in Orange County. However attractive for its minimization of controversy, all 60 beds could not have been transferred from South Seminole because to do so would have raised its occupancy above 80%, "an untenable result." (Tr. 630). For the additional 30 beds, "Lucerne seemed like a logical choice, given its bed size and its utilization." (Tr. 628). The design of the proposed hospital is based on another ORHS facility: South Lake Hospital, a replacement facility that opened in January of 2000. Florida Hospital's Florida Hospital also proposes to construct a 60-bed acute care hospital in the City of Oviedo. Unlike ORHS, Florida Hospital owns the site, 15 acres at 8000 Red Bug Lake Road near an intersection with the Greenway. The site currently includes a two-story, 41,000 square foot medical office building and a one- story, 6,000 square foot urgent care center. A two-story, 161,000 square foot facility is proposed to be constructed on the remaining vacant space at the site that has been approved under the Development of Regional Impact process for a 120-bed hospital. Ownership of a DRI-approved site will save Florida Hospital time and expense entailed by permitting requirements. All 60 beds will be part of an innovative design referred to as a "universal room and universal care delivery model." For the present, Florida Hospital does not intend to provide obstetrics at the Oviedo facility but "all of the universal patient rooms are capable of being LDRP rooms" (tr. 1181) should Florida Hospital decide in the future to provide obstetric services at the hospital. Florida Hospital will transfer 60 beds from Orange County facilities so that Florida Hospital's proposal will increase the sub-district's bed inventory by 60 beds, 30 more than the increase that will be affected by ORHS' proposal. Just as with ORHS, Florida Hospital's proposal will not increase the bed inventory in District 7. Fifty beds will be transferred from Florida Hospital's Winter Park facility and 10 beds will transferred from Florida Hospital's Apopka facility. AHCA's View of the Proposals The Agency's conclusion that the applications did not demonstrate "not normal" circumstances was reached with difficulty. Review of the applications taxed the agency's decision-making process because of the challenging circumstances presented by the applicants. As Jeffrey Gregg testified for the Agency, when there is "no fixed-need pool," AHCA look[s] at applicants in terms of a unique set of circumstances that they present . . . and in this instance, The circumstances . . . in this case challenge the system, make it more difficult for [the Agency] to make a sound decision in the tradition of the CON program. (Tr. 723). However much in keeping or not with the tradition of the CON program, the determination that there were no "not normal" circumstances to justify need afforded a benefit to the Agency; it would not have to make the difficult choice between the applications. While it could have granted both applications, an option considered by the Agency (see tr. 729), no party contended in this proceeding that circumstances justify two new 60-bed hospitals in Oviedo. If need is proven for but one hospital, then a selection must be made. Yet, at every turn, AHCA has found one advantage held by an applicant to be defeated by another held by its opponent or one set of circumstances that would normally be an advantage neutralized by other considerations. For example, in view of the nature of the Orlando market, AHCA reasonably did not give much weight to ORHS' proposal to add fewer beds than Florida Hospital to the sub- district despite the fact that usually there would be advantage to a mere intra-sub-district move. In the absence of fixed need, for example, such a move would not have to be supported by "not normal" circumstances. To the contrary, however, from the point of view of practicality, it makes more sense "to take beds from a more urban setting [in Orange County, a different sub-district] where they are not being used [as proposed by Florida Hospital] and move them to a new rapidly growing area where there are not hospital beds." (Tr. 739). A sense of practicality guided AHCA throughout its CON review in this case. The Agency, in fact, approached the applications by "trying to be as practical as possible." (Id.) As explained by Mr. Gregg, again on behalf of AHCA: [The Agency] do[es] not give much weight to the fact that [the applicants] would be crossing subdistrict lines here and that one of them [ORHS] is in a position to . . . add fewer beds to the planning area. That's noted in the SAAR, but practically speaking, we are talking about a metropolitan area here. We are talking about in both cases large systems wanting to move beds from one part of their system to another part. So in many ways, . . . once again, [ORHS and Florida Hospital] are really well-matched and difficult to distinguish. (Tr. 724, emphasis supplied). The difficulty inherent in distinguishing between the applicants was repeatedly emphasized by the Agency. The point was brought home once more in questioning of Mr. Gregg by counsel at hearing: Q [W]ith regard to the minute distinctions between the applicants, at your deposition, some of the statements you made in that regard included [that ORHS and Florida Hospital] are both good citizens. All of these things in this case, coming up so close and so equal, that . . . in terms of CON analysis, it becomes very difficult . . . to make a distinction between the two of them. They are both just that good. And then also [the Agency] think[s] they compare very favorably, and very evenly, noting again and again and again that they are very, very close, very, very comparable. Is that still your position here today? A Yes. (Tr. 766-7). However close the Agency regards the two, there are differences in the applications. While some may not be of great benefit to a decision, others may serve to sustain a principled choice. Differences in the Applications Obstetrics The leading reason for hospitalization among area residents is the need for obstetrical services with births running at more than 2,000 per year. During the 12-month period ending June 2000, for example, childbirths accounted for 2,041 discharges. Of the top ten DRGs for discharges among area residents, uncomplicated vaginal delivery accounts for the most discharges, cesarean section ranks third and vaginal delivery with complications is seventh. In keeping with the demand for obstetrical services, the utilization patterns of the population in the Oviedo Service Area and the area's age composition, upon the opening of its facility, ORHS proposes to provide obstetrical services. The proposal is also due, in part, in response to the closing of the obstetric program at Florida Hospital East in May of 2001. There is physician support for ORHS' proposed obstetric services. Robert Bowles, M.D., testified by deposition that his group practice, Physician Associates of Florida, comprised of 14 obstetricians and gynecologists would cover obstetrics at an Oviedo hospital. While Dr. Bowles would not personally admit obstetrics patients at the new hospital, three of his partners would. Florida Hospital does not propose to provide obstetrics upon opening although it has designed its physical plant to provide an OB unit so that Florida Hospital would have the capability of initiating that service without a problem. In other words, Florida Hospital's proposed facility would be "OB- ready." (Tr. 725). Unlike ORHS, Florida Hospital does not have physician support for providing obstetric services at its proposed facility, a part of the reason for not offering OB. The basis for Florida Hospital's lack of physician support is a malpractice insurance crisis for obstetricians. Florida Hospital's proposed facility is not projected to open for another three years. If, during that time, the malpractice crisis eases and there is greater physician coverage availability, Florida Hospital could open obstetric services at the same the hospital opens since it will be OB-ready. Another reason that Florida Hospital has decided against offering obstetrics upon opening is that most maternity patients are more comfortable delivering babies in a setting that has neonatal intensive care services available. Two such settings are ORHS-Arnold Palmer and Florida Hospital's main campus. Indeed, a significant number of maternity patients from Oviedo are choosing to travel past multiple hospitals that offer obstetric services to have their babies delivered at one or the other of these two hospitals. Arnold Palmer, in fact, is the leading provider of obstetrical services to the residents of the Oviedo area's two most populous zip codes: 32708 and 32765, both more than 30 minutes driving time away from the hospital. Medicaid and Charity Care Conditions Approval of ORHS' CON is conditioned on a minimum of 7% of total annual patient days for Medicaid patients and 1% for charity care. Florida Hospital's application offers no conditions with regard to Medicaid or charity care. Like ORHS, Florida Hospital is one of the top ten providers in the State of indigent care, and a disproportionate share Medicaid provider. The Agency's view of the difference between ORHS' provision of indigent care conditions and Florida Hospital's decision to not condition its application was explained by Mr. Gregg: Conditions [such as those for indigent care] are important when it allows us to distinguish between applicants. They are less important when we have competing applicants, both of whom has such strong track records as these two do. . . . [W]e look at evidence of past performance relative to indigent care . . . . [I]n a case like this . . . both of these applicants have such good records in th[e] area [of indigent care]. They are both in the top ten statewide. . . . [A] promise of this condition or that condition [does not] give us particular concern one way or the other. They are both very good in that area [of Medicaid and charity care] and very tough to distinguish between. (Tr. 735-6). Architectural Design and Site The architectural plans of both applicants meet all codes that apply to a new hospital in the state of Florida. The ORHS design is tried and proven at ORHS' South Lake facility and will work on a 35-acre site. The size of Florida Hospital's site, 15 acres much smaller than ORHS', led to criticism of the site from ORHS experts. But the site is large enough to incorporate growth in the future. It can accommodate 320 beds and ancillary services. The design, moreover, takes these expansion capabilities into account. Related to the size of the site, the site's conservation area, comprised of wetlands and a forested upland buffer that will remain undeveloped indefinitely also produced criticism that the site is too cramped for a new hospital. But the conservation area, with its mature tree canopy, presents advantages. The hospital was designed to incorporate the view of the conservation area from hospital rooms because such a view is beneficial to the healing process. Furthermore, the conservation area can be used to satisfy water retention requirements. Florida Hospital's site is DRI-approved and part of a DRI master storm water plan that connects many ponds and wetlands. Surrounded by three roads, it has excellent access from existing roadways. Vehicular circulation is split to provide different public, service and emergency entrances. Innovation by Florida Hospital Unlike traditional hospital care models where the patient is moved from room to room depending on type and intensity of care, all care and services are provided to the patient in one "universal" room under the "universal delivery of care model." The model was developed by Florida Hospital. "The nursing leadership of the universal room design . . . was under the direction of Connie Hamilton." (Tr. 1080). Ms. Hamilton, accepted as an expert in nursing and nursing administration, explained at hearing that under the model, the room is designed to provide any type of care the patient might need. Whether the patient is admitted in acute care and then moves to intermediate care or med-surg, all care is provided within one "universal" room. Not only does the patient stay in one place, but as Ms. Hamilton testified, "[t]he nurses stay in one place in providing that care to [the patient] and the families know where the patient is and the physician knows where the patient is [at all times]." (Tr. 933). The universal care model streamlines the interactive processes of care of a patient. The care and attention of physicians, nursing staff and families devoted to moving the patient from room to room and keeping track of the patient as type and intensity of care changes is reduced to nearly zero if not eliminated entirely. The time, energy and resources formerly devoted to all that is entailed with changes in the patient's room is then free to be re-directed to care and attention paid to the patient. The result is enhancement of Florida Hospital's ability to provide "whole person" care consistent with Adventist principles of health care. The universal care delivery model is an innovative approach to the delivery of healthcare. Pioneered by Florida Hospital at Celebration Health, the universal care delivery model has been shown there to reduce medical error, reduce length of stay, reduce pharmacy costs, reduce nursing workload, reduce housekeeping work, and probably to reduce infection rates. Following the universal care model employed at Celebration Health, Florida Hospital has designed its proposed Oviedo hospital facility with universal rooms. Consistent with the universal care delivery model, the rooms are designed to improve the healing experience during hospitalization and minimize the patient's feeling of being in a hospital setting. Another benefit of the universal care model is high physician satisfaction due to continuity of nursing care and other factors. The physicians know where the patient is, that is, in the same location every day. Physicians, moreover, are not called at all hours of the day and night to effectuate patient transfers to other rooms. Kathleen Mitchell has studied the universal care model and published and submitted articles on the model to nursing journals. She has consulted with hospitals around the country interested in the model as well as the "health care arm of the Department of Defense, Air Force, Army, Navy, Veteran's Administration." (Tr. 1084). Ms. Mitchell, accepted as an expert in nursing amplified the testimony of Ms. Hamilton. With regard to the problem the universal care delivery model is designed to address, Ms. Mitchell testified: [T]ransferring patients for different levels of care . . . fractures continuum of care. It is . . . disruptive to everyone . . . involved . . . to the patient and their families . . ., to nursing, pharmacy, the physicians . . . . It creates a great deal of anxiety for patient and the families . . . even [those] who are getting better and moving to a lower acuity of care. One of the most significant things about transferring patients for different levels of care is it involves a great deal of work. Not only bundling the patient up, but the documentation and all the communication that goes along with securing a new location for the patient and expediting a transfer. And moving patients around creates a risk of medical error. The length of stay in hospitals has gotten so short and everybody is focused on reducing the length of stay that in the traditional model of care, nurses are turning over more than half their patient assignment daily . . . . [T]here is the confusion and risk that goes along with that. (Tr. 1086-1088). The benefits of the reduction and elimination of transfers produced by the universal care model were listed by Ms. Mitchell: increase in the continuity of care, reduction in nurse workload, high physician satisfaction, reduction in emergency room waiting time, family satisfaction, connectivity between patient, family and staff. Others were elaborated on by Ms. Mitchell. For example, reduction in pharmacy costs, probable reduction in infection and reduction in housekeeping costs: When you are meeting the needs of the patient in one location, you are not leaving medications behind or sending them to the wrong place, and there is work that nurses and pharmacists do with calling each other with ['] where is it, I can't find it, I sent it[',] all that goes away. We are demonstrating a low incidence of nosocomial infections because we expose our patients to one environment of organisms. This is a very difficult one to prove; even though we have a low incidence of nosocomial infections, we also have a fairly new facility [at Celebration], but it makes common sense that if you are reducing the transfer of the patient and the exposure . . . to different environments, you are reducing their exposure to organisms and will have a lower . . . infection rate. . . . [W]e don't strip linens off the beds and clean the beds where the bed was just made three hours ago, with all the patient transfers that are involved. So there is a reduction in . . . housekeeping work and . . . linen expense. (Tr. 1089-1090). Like the housekeeping efficiencies, the nursing staff benefits from the efficiencies associated with supplies. All of the supplies the nurse needs to care for the patient are close by, so the nurse saves time otherwise retrieving supplies from down the hall or in other areas of a hospital wing. Another benefit of the design is "connectivity to the outside world. The rooms have large windows . . . patients feel connected to the outside world . . . . " (Tr. 1091). This design feature will make use of the conservation area on the Florida Hospital site and the soothing vista it will provide to the patient, and assist in the healing process. Other Design Features Design drawings are a living and continually evolving process. The planning process of Florida Hospital for the design of its new Oviedo hospital involved specialty department experts and ancillary representatives discussing delivery of quality care for a patient throughout the system. The specialty experts and ancillary representative include radiology, emergency department, lab, pharmacy, and respiratory. The involvement of these people assures optimal patient flow throughout the system. In Florida Hospital's design plans, the patient flow and interaction between departments are well designed and well laid out so as to minimize the opportunity for confusion. In order to maximize efficiency, a larger number of beds in one nursing unit works better than smaller pockets. Florida Hospital's design plans have one 40-bed unit and one 38- bed unit. This design gives more flexibility and can expand or shrink more easily as needed. You don't have to open up another unit and staff it so often, when adding only one or two patients. Florida Hospital designed its facility specifically to take advantage of the economies of scale that being a satellite hospital in a larger system provide. For example, Florida Hospital's general storage, central lab, and other areas were purposely designed smaller than one would typically find because Florida Hospital operates a system-wide central warehouse, thus greatly reducing the need for central storage areas. Likewise, Florida Hospital operates a system-wide central clinical lab, thus minimizing the space necessary within a hospital like Oviedo for lab space. ORHS did not design its facility to take advantage of the economies scale of being part of a system. Presence in Oviedo Florida Hospital has had a presence in the Oviedo community since the 1970's, when it purchased land in the Red Bug corridor area. In the 1980's, Florida Hospital built a medical office facility in Oviedo and began to recruit and encourage physicians to practice in the area. When Florida Hospital acquired Winter Park Hospital, its commitment to the community of Oviedo increased by virtue of the fact that the Winter Park Hospital organization already had property and outpatient facilities in Oviedo. The result of Florida Hospital's early presence in Oviedo is that it has a high degree of physician support in place in the Oviedo community. Many of the primary care physicians in Oviedo refer their surgical cases to Florida Hospital. Florida Hospital purchased Winter Park Hospital on or about July 1, 2000. With that purchase, Florida Hospital acquired the hospital site in Oviedo. With the purchase of Winter Park Hospital, Florida Hospital also "purchased" Winter Park's plan to build a hospital in Oviedo. The Florida Hospital site has long been recognized as the "Hospital Site" in Oviedo. Immediately after purchasing Winter Park Hospital, Florida Hospital went to work on developing a plan to build a hospital in Oviedo. Florida Hospital began meeting with Oviedo city leaders in the fall of 2000 and early 2001; Florida Hospital also assembled a team of people from all areas of Florida Hospital including radiology, clinical services, marketing, finance, facilities, and engineering to work toward the development of a Certificate of Need application for a hospital on its site in Oviedo. Florida Hospital's two existing medical office buildings in Oviedo contain over 60,000 square feet of medical office space, in which are housed physicians practicing in a wide range of areas including Family Practice, Internal Medicine, General Surgery, Orthopedic Surgery, Urology, Radiology, Gastroenterology, Ear, Nose and Throat, OB/GYN, and Dental and Psychological Practitioners as well. These physicians are all currently on the staff of Florida Hospital. Also included in these facilities are a Florida Hospital owned and operated radiology center, outpatient rehabilitation center, and outpatient lab. The radiology center offers general radiology services, including CT scanning and ultrasound. The larger of the two medical facilities that Florida Hospital owns in Oviedo is located on the site where the new hospital will be located. This is the facility that includes the outpatient radiology, rehabilitation and laboratory services. An urgent care center is also located on the site. As a result, residents of Oviedo are used to coming to Florida Hospital's site for medical services and already recognize it as a medical facility site. The fact that Florida Hospital has such a significant presence in the Oviedo Community, and that a large number of staff physicians are already in place in Oviedo, is a great benefit because of the existing referral patterns in place between the physicians at the existing Florida Hospital facilities in Oviedo and specialists and sub-specialists on Florida Hospital's staff. In contrast, ORHS had an outpatient surgery center in Oviedo; however, it has been closed due to lack of physician support. Likewise, ORHS originally offered radiology diagnostics at its Oviedo office building, but has since sold that business to the radiologists. Finally, ORHS does not own the medical office building in Oviedo anymore, having sold it two weeks before this final hearing commenced. Dr. Joseph Portoghese, a Board Certified Surgeon, practicing in the Orlando area for over 13 years and president- elect of the Florida Hospital medical staff, testified that his group, Surgical Associates, which is made up of six surgeons, derives approximately 20% of their patients from the Oviedo area. In his opinion, Florida Hospital knows the Oviedo population best as evidenced by its "major presence" in Oviedo with its two facilities. Dr. Portoghese also testified that his group knows most of the primary care physicians in the Oviedo area and that a good many of them send their surgical cases to his group. Dr. Portoghese is on the staff of Florida Hospital, but not on the staff of Orlando Regional. Dr. Schamberger, a family practitioner who has practiced in Oviedo for 16 years and whose patients come primarily from the Oviedo, Chuluota, Winter Springs and East Orlando area testified that Florida Hospital has the best infrastructure for the provision of medical care in the Oviedo area. "The physicians who provide a great bulk of the care for that Oviedo, Chuluota, Winter Springs area practice at Florida Hospital. Their referral patterns are to Florida Hospital. Florida Hospital provides us with all the specialty and sub- specialty care we need for our patients." Dr. Schamberger is on the staff of Florida Hospital, but he is not on the staff of Orlando Regional. Dr. Schamberger further testified to the disruption in continuity of care that would occur for many Oviedo area patients whose physicians are on the staff at Florida Hospital if Orlando Regional were to be the only applicant approved to build a hospital in Oviedo: "[I]ts a negative impact for continuity of care. If I have been attending a patient for many years, the first thing that happens to a patient when they get in the hospital is that they have a history and physical examination done to establish what their underlying medical conditions are. I know a lot more about that from my patients than someone who doesn't see them and doesn't know them." (Tr. 1318) Dr. Cintron, a physician practicing in the area of Internal Medicine, whose main office is in Oviedo at the Florida Hospital site, testified that she has approximately 3,000 active files and 75% to 80% of those are in the Oviedo area. She has been practicing in Oviedo since 1994. Dr. Cintron testified that approximately 85% of her patients that get admitted to a hospital are admitted to one of Florida Hospital's facilities. Also, when she makes a referral to a specialist or a sub-specialist, approximately 85% of those patients go to a Florida Hospital facility. Competition "[T]he U.S. health care system is a competitively driven market . . . with some regulatory components and based on a managed care model." (Tr. 485). Rather than every insurance plan having a contract with every provider, the managed care model uses selective contracting. Competing health insurance plans select providers with which to contract for the provision of health care services to their subscribers. The ability of the competing insurance plans to engage in selective contracting requires providers such as the two hospitals in this case to compete along a number of dimensions including price. When successful, this competitive price model holds down price and maintains quality. The State of Florida has a "fairly well developed and active managed care sector." (Tr. 507). "[M]anaged care in and of itself [however] is not really able to save much money for consumers. . . . [T]he key ingredient in the ability of managed care plans to control health care cost increases is the competitiveness of the hospital market, the structure of the market in which they are negotiating on behalf of their health plan subscribers." (Tr. 500). The parties define the "market" differently. Florida Hospital uses the Elzinga-Hogarty ("EH") Test. The test, along with appropriate supplemental information, indicates that the market is all of Orange and Seminole Counties or the tri-county area that also includes Osceola County. Whether a two county or tri-county market, Florida Hospital refers to its market as the metropolitan Orlando market or the "overall Orlando market." Orlando Regional identified a smaller area as the relevant market, one that is more local to Oviedo. The reason for this more local market was explained by Glenn Alan Melnick, Ph.D., and an expert in health care economics who testified for ORHS: [I]n order for [managed care plans] to attract subscribers, they have to have a health plan that's attractive to people. And one of the features that people look for in their health plans is the availability of local hospital services. . . . [I]n order to make their products marketable, they have to include reasonably accessible hospitals . . . [I]f there is limited local competition, then the opportunities for them to generate price competition by leveraging competitive conditions . . . are very limited and [the managed care] model will not be successful. (Tr. 489). Dr. Melnick used the five and eight zip code Oviedo Service Areas as defined by the applicants as the market. He calculated Herfandahl-Hershman Index ("HHI") valuations for each zip code in the two Oviedo Service Areas. He also calculated HHI valuations for another seven zip codes in Orange County "to provide background to [his] understanding of the allocations in [the] area . . . . ." (Tr. 516). Dr. Melnick's calculations showed that Florida Hospital has a market share between 60 and 69% for the five zip codes in Florida Hospital's Oviedo Service Area and it showed a market share of between 25% and 59% for the three zip codes in ORHS' Oviedo Service Area that were not included in Florida Hospital's Oviedo Service Area. In each of the seven zip codes in the area outside the Oviedo Service Area, Florida Hospital's market share was higher: in excess of 70%. The analysis led Dr. Melnick to conclude that the market is highly concentrated in favor of Florida Hospital. Using the zip codes in the Oviedo Service (and it appears from the record the seven not in either applicant's Oviedo Service Area that Dr. Melnick had analyzed for background purposes), Dr. Melnick concluded that if the CON is awarded to Florida Hospital "[i]t would make an already concentrated market much more concentrated." (Tr. 524). Florida Hospital's relative market share would rise from 65.8% to 85.7%. Orlando Regional's would drop from 27.4% to 11.5%. The award of the CON to Florida Hospital would, moreover, "seal its already existing market power into the future." (Id.) Conversely, awarding the CON to ORHS led Dr. Melnick to conclude that the market as he defined it would be more competitive; Florida Hospital relative market share would drop to 51% and ORHS' would rise to 44%. What Dr. Melnick's relative market shares would have been had he not used the seven zip codes he selected outside the Oviedo Service Areas of the two applicants does not appear to have been shown by ORHS. Including the seven zip codes outside the Oviedo Service Areas for determining the relative market share that led to Dr. Melnick's conclusions runs counter to his premise that the market should be a local one, that is, an Oviedo market. It is not clear what relevance these seven zip codes had to his analysis since their inclusion runs counter to the underpinnings of his approach to the issue. If the overall Orlando market used by Florida Hospital is considered the market, the conclusion is that, whether a CON for an Oviedo hospital is awarded to ORHS or Florida Hospital, the impact on relative market share is minimal. As for pricing, there has been no significant pricing difference between Florida Hospital and ORHS for Oviedo residents. Furthermore, both Florida Hospital and ORHS contract with managed care companies on a system-wide basis; Florida Hospital, moreover, uses a single master charge structure for all of its Orlando area campuses. It is not likely that the presence of a hospital in Oviedo would enable either Florida Hospital or ORHS to control pricing.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order on the basis of the facts found in this order concluding that "not normal" circumstances exist for the construction and operation of a new 60-bed hospital in Oviedo and that Florida Hospital's CON application be approved and ORHS' be denied. DONE AND ENTERED this 18th day of November, 2002, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of November, 2002. COPIES FURNISHED: Lealand McCharen, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 James M. Barclay, Esquire Ruden, McClosky, Smith, Schuster & Russell, P.A. 215 South Monroe Street, Suite 815 Tallahassee, Florida 32301 Steven R. Bechtel, Esquire Mateer & Harbert, P.A. Post Office Box 2854 225 East Robinson Street, Suite 600 Orlando, Florida 32802 Stephen K. Boone, Esquire Boone, Boone, Boone, Hines & Koda, P.A. 1001 Avenida del Circo Post Office Box 1596 Venice, Florida 34284 Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Suite 310G St. Petersburg, Florida 33701
The Issue The issue presented by these cases is whether fines totaling $350.00 should be imposed upon the Respondent for its alleged failure to report the absence of two residents from the facility, the first occurring on December 4, 1980, and the second on January 7, 1981, to the Petitioner as required by Chapter 10A-5, Florida Administrative Code.
Findings Of Fact The Respondent Jubilee Retirement Center is licensed as an Adult Congregate Living Facility (ACLF) pursuant to the "Adult Congregate Living Facilities Act", Part II, Chapter 400, Florida Statutes. On December 4, 1980 a sixty-three-year-old female resident of the facility who was on medication left the center sometime between the lunch and evening meal. A thorough search of the Center and the immediate neighborhood by Center personnel proved fruitless and a missing person report was promptly filed by the Respondent with the City of Miami Police Department. (Case No. 339- 3748B). The resident's husband was also contacted immediately by the Respondent. On December 12, 1980, an article appeared at page 4B of the Miami Herald entitled, "Woman Walks Out 0f Nursing Home, Vanishes." The article apparently alerted the Department to the disappearance of this particular resident. Mr. Rosenfeld, Administrator of the Jubilee Retirement Center, was contacted by Mr. Alvin DeLaney, ACLF Program Specialist, on December 12, 1980, concerning this incident and at that time he informed Mr. DeLaney that the resident was located at the Miami Beach Mental Health Center and sent from there to Dodge Memorial Hospital on December 8, 1980. On December 15, 1980, the resident was transferred from Dodge Memorial to South Florida State Hospital. Following this incident, Rosenfeld discussed with DeLaney the requirements of Rule 10A-5-06, Florida Administrative Code, which requires the reporting of major incidents as defined at Rule 10A-5.01(18), Florida Administrative Code, within 24 hours following the occurrence of the incident. Rosenfeld agreed to follow the Rule in the event of any future problems. Rosenfeld was unaware of this Rule since he had not received a copy of Chapter 10A-5 which was mailed by the Department to all licensed ACLF operators in July, 1980. Following his discussion with DeLaney, Rosenfeld also believed that in computing the time limit, three working days would be allowed and weekends and holidays would be excluded. On January 12, 1981, Bill Garrett, then an ACLF Specialist with the Department, received a call from Rosenfeld concerning the disappearance on January 6, 1981, of a male resident from the Center. On January 7, 1981, Center personnel had reported the resident to the City of Miami Police as a missing person and contacted a relative of the resident. From January 17-27, 1981, Rosenfeld was in frequent contact with the Department concerning efforts to locate this resident. The resident was located through an obituary in the Miami Herald which stated that the resident passed away on January 26, 1981 following a heart attack which occurred on January 6, 1981, in a MacDonald's Restaurant near the Center. Following this incident, Rosenfeld agreed to notify the Department within twenty-four hours of discovery of any missing resident. The Center has implemented policies designed to minimize the residents' ability to leave the facility without notifying Center personnel and at the same time guaranteeing basic privacy rights of residents. A twenty-four hour a day sign-in and sign-out sheet is now located at the front desk and alarms have been installed at all other exits. Many of the residents are former mental patients and this coupled with the size and physical lay-out of the facility makes it difficult for the Center to be aware of the movement of all residents. Additionally, at the same time of these incidents the Department had no access to the Missing Persons Report Registry maintained by law enforcement agencies and could do little to assist in the search for missing residents other than contact friends or relatives who might be unknown to the ACLF operators.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That the Department enter a final order assessing a $100.00 administrative fine for the failure to report a major incident which occurred on December 4, 1980 as alleged in the administrative complaint filed January 23, 1981, and dismiss the complaint filed February 27, 1981 which alleged a failure to report a major incident occurring on January 7, 1981. DONE and ORDERED this 14th day of July, 1981, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of July, 1981. COPIES FURNISHED: Martha Barrera, Esquire Department of Health and Rehabilitative Services 1320 South Dixie Highway Eleventh Floor Coral Gables, Florida 33146 Nelson Rosenfield, Administrator Jubilee Retirement Center 8000 Biscayne Boulevard Miami, Florida 33138
The Issue The issue for resolution is whether proposed amendments to Rule 10- 5.042(14)(a) and (f), F.A.C. constitute an invalid exercise of delegated legislative authority, as asserted by petitioner.
Findings Of Fact In 1987, the department began to develop a rule to govern certificates of need ("CON") for Level II and Level III neonatal intensive care services in hospitals (hereinafter referred to as "NICU"). That process ultimately led to the department's publication of Proposed Rule 10-5.011(1)(v), F.A.C. (now renumbered as Rule 10-5.042, F.A.C.) on November 3, 1989. (Joint Prehearing Stip., p.4). All pertinent provisions of the NICU Rule were upheld in a final order issued by DOAH in June, 1990, and affirmed by the District Court of Appeal, First District, in St. Mary's Hospital, Inc. v. Department of Health and Rehabilitative Services, 12 FALR 2727 (DOAH, June 12, 1990, aff'd, Baptist Hospital v. Department of Health and Rehabilitative Services, 578 So.2d 1004 (Fla. 1st DCA 1991). (Joint Prehearing Stip. p. 4). The NICU Rule became effective on August 6, 1990. (Joint Prehearing stip., p. 4). Paragraph 14 of the NICU Rule addresses the entitlement of hospitals to implement, or to continue to operate Level II or Level III NICU services. Paragraph 15 prescribes the process for creating an inventory of those hospitals authorized under the NICU Rule to provide Level II or Level III NICU services. Paragraph 15 provides that the department publish a preliminary inventory of those hospitals it has determined meet the entitlement criteria contained in Paragraph 14. It provides further that hospitals be allowed to contest the preliminary inventory. (Rule 10-5.042, F.A.C.). The department published a revised preliminary inventory on September 21, 990, in the Florida Administrative Weekly, authorizing Winter Haven to operate an 11 bed Level II NICU Unit. (Joint Prehearing Stip., p.4). Winter Haven was included in the inventory based on its documentation that the agency had approved construction plans for creation of NICU beds in an expansion project. On August 6, 1991, Hearing Officer Veronica Donnelly issued a recommended order in Lakeland Regional Medical Center, Inc. v. Department of Health and Rehabilitative Services, DOAH Case Nos. 90-7682 and 90-7683, regarding Lakeland's challenge to Winter Haven's inclusion in the preliminary inventory. Among other things, the Hearing Officer recommended that the department enter a final order excluding Winter Haven from the inventory of facilities authorized to provide Level II NICU services. (Joint Prehearing Stip., p.4). The Hearing Officer's recommended order concluded Winter Haven had not demonstrated that it complied with the grandfathering provisions of subparagraph 14 of the NICU Rule. It further concluded that DHRS lacked the authority to adopt a policy which conflicted with the plain meaning of the NICU Rule. On September 23, 1991, the department issued its final order. (Joint Prehearing Stip. p.5). DHRS' final order concurred with the Hearing Officer's recommendation that Winter Haven was not entitled to be included in the inventory of Level II NICU beds pursuant to the criteria contained in the NICU Rule. Nonetheless, the final order held that the department was estopped from excluding Winter Haven from the inventory on the theory of equitable estoppel, and, therefore, ordered that the final inventory include 11 Level II NICU beds at Winter Haven. The final order found that Winter Haven relied on representations by the department over a five-year period to establish its Level II NICU unit, hire employees and commence operation. (Lakeland composite exhibit #2). On October 14, 1991, Lakeland filed a notice of appeal appealing the portion of the final order requiring that the final inventory include 11 Level II NICU beds at Winter Haven. (Joint Prehearing Stip., p. 5). As a result of the Hearing Officer's recommended order, the department initiated the current rulemaking proceedings which culminated on December 27, 1991, when DHRS published the first version of the proposed amendments to Rule 10-5.042(14)(a) and (f) in Volume 17, No. 52, Florida Administrative Weekly. On March 13, 1992, however, the department withdrew those proposed rule amendments. (Joint Prehearing Stip., p. 5). On March 13, 1992, DHRS published a second version of the proposed amendments to Rule 10-5.042(14)(a) and (f) in Volume 18, No. 11, Florida Administrative Weekly, which were substantially identical to the first version. On May 29, 1992, the department withdrew the second version of the proposed rule amendments. (Joint Prehearing Stip., p. 5). On May 29, 1992, DHRS published a third version of the proposed amendments to Rule 10-5.042(14)(a) and (f) in Volume 18, No. 22, Florida Administrative Weekly, which were substantially identical to the first and second versions of the proposed amendments, and which are the subject of Lakeland's challenge in this proceeding. (Joint Prehearing Stip., pp. 5-6). At the time the department proposed the rule amendments that are at issue in this proceeding, there were only three providers of which the department was aware, i.e., Alachua General Hospital, Winter Park Hospital, and Winter Haven, who had construction plans deemed approved by the department allegedly authorizing neonatal intensive care beds prior to October 1, 1987. (Joint Prehearing Stip., p. 6). Alachua General Hospital and Winter Park Hospital were included in the preliminary inventory of Level II NICU beds. Their inclusion in the inventory was either not challenged, or was challenged and subsequently dismissed. Alachua General Hospital and Winter Park Hospital were also included in the final inventory of Level II NICU beds. Their entitlement to be included in the final inventory is final and is not subject to further appeal. The department is not currently aware of any other providers, who have construction documents approved by the department prior to October 1, 1987, as a basis for being included in the inventory under the proposed amendments. (Joint Prehearing Stip., p. 6). Elfie Stamm is responsible for rule development, special studies, and the development of fixed need pools at the department. Ms. Stamm was responsible for the development of the NICU Rule and the proposed amendments. She also was responsible for evaluating the information submitted to the department by providers seeking to be included in the inventory of the NICU beds under the NICU Rule. 19 . The proposed amendments merely authorize one additional basis for "grandfathering in" neonatal intensive care services at hospitals. (Ex. 1; Proposed Amendments, Florida Administrative Weekly, Volume 18, No. 22, May 29, 1992, pp. 3061-3062). The amendment is intended to allow the agency, under specified conditions, to acknowledge a type of prior departmental authorization for neonatal intensive care services which is not specified in the current rule. The proposed amendments represent the agency's current policy adopted in October of 1990, or within about two months of the effective date of the NICU rule. Knowledge about the problem first came to light within two months of the August 1990 effective date of the new NICU rule when Alachua General Hospital sought grandfathering under the new rules because of its approved construction documents. The agency believed that the construction plans that it had approved for Alachua General came under its rule. The department considered it consistent with the grandfathering provision for hospitals which had indicated on their licensure application that they provide the services. Also soon coming forward for grandfathering because of approved construction documents were Baptist Hospital in Pensacola, Winter Park Hospital in Orlando, and Winter Haven Hospital in Winter Haven, Florida. Alachua General and Winter Park were considered grandfathered. Because Baptist had not produced sufficient evidence that it had approved construction documents, it was denied. If Baptist can prove it had approved construction documents it might later be grandfathered. When the department promulgated the existing rule, had it been aware of the issue involving documents approved for NICU construction, it would have specifically written into the rule the provision it is now promulgating. The already existing grandfathering provision includes facilities and providers which had not received anything from the agency in the way of approval, including those which had not received a CON, and had no recorded NICU services on their license application. The current rule includes hospitals which had no contact with the department, no approvals, no construction plans, and no licensure application. If grandfathering a provider which established the service without any approvals of any kind is appropriate, and is now part of the rule, the department considers it should approve a hospital which affirmatively obtained approval construction documents for this service. Such facilities have proceeded in good faith, approved by the same agency that issues certificates of need, so the department believes that they should be authorized to provide the service. The department's Office of Plans and Construction had by 1987 specific construction standards for Level II and Level III NICU beds and still does. The Office of Plans and Construction in the past approved specific levels of care for NICU. In 1987 there were published standards for plans and construction that covered Level II and III neonatal care beds. The department, in its preparation of this amendment, did not analyze all factors listed under Section 381.704(3), F.S., because that statute refers to the development of need methodologies and the subject amendments are not a need methodology. They are used to establish an inventory of existing beds which inventory is a factor in the need methodology. NICU services are tertiary health care services, services which are intensive and complex, and generally present a certain degree of risk in the delivery of the service. As a result, tertiary health care services are regionalized. NICU services, therefore, are not necessarily available in every hospital which provides obstetrical services to its patients. There was no competent evidence that the proposed rule amendments will cause disruption in services. Those grandfathered in under this policy are already on inventories and in operation, including Winter Haven. Ms. Stamm testified she could not conclude from existing evidence that disruption would occur, and to the contrary, increased competition might be a result, along with the potential for improvement in service. Based on department experience, it is not likely that any hospitals remain with approved construction plans from prior to October, 1987, which would be able to come forward now to seek approval, although as found above, it remains possible. Any grandfathered facility (under the proposed amendments) must meet all licensure requirements for NICU beds, and must meet all requirements of the NICU rule within one year (Rule 10-5.042(14)(i), F.A.C.;). Medical quality is protected under licensure rules.
Findings Of Fact At the time of the denial of petitioner's request for a certificate of need, on January 18, 1977, nine CAT-Scanners were operational in Dade County. Two additional CAT-Scanners had been granted certificates of need approval and were on order. Three additional physician owned scanners for which certificate of need is not relevant were also on order. Of the nine CAT-Scanners currently operational in Dade County six were granted certificates of need and the remaining three are physician owned. During the calendar year 1976 three of the CAT-Scanners in operation in Dade County performed less than 2,000 scans. The lowest performed 1256. On the other hand the most active CAT-Scanner, which is owned by a physician, operated 14 hours per day and performed 3,269 scans. The next highest number of scans was performed by the CAT-Scanner at Jackson Memorial Hospital which numbered 3,059. Guidelines established by HRS for granting certificate of need approval for CAT-Scanners is 2,400 scans per year. This number is based on an average of 10 scans per day, 240 days per year. This excludes week-ends and holidays. The national average of scans per day per machine is 13 which indicates the average machine does at least 2,750 scans per year. The cost per scan is the total yearly cost for running the scanner divided by the number of scans done in a year. Although the cost of operating the scanner varies with the number of procedures done these variable costs are relatively small as compared to indirect costs and total costs. A doubling of the number of patients from 40 to 80 per week leads to only a 14 percent increase in total costs (Exhibit 16). In the United States in 1976 Florida was second only to California in the total number of CAT-Scanners with 27 compared to California's 60. However, Florida has one machine per 310,000 population and California one machine per 353,000 population. Of the 27 machines in Florida at the time of that determination seven were located in Dade County. Dade County then provided one machine per 228,000 population. North Miami General Hospital is a general hospital with 334 beds with the full range of facilities normally provided by general hospitals. It is preferred to locate CAT-Scanners in general hospitals where 24 hours per day service can be provided should the need arise. Petitioner's projected use of the machine was 1,500 procedures the first year of operation and 2,000 procedures the second year (Exhibit 1). The South Florida Health Systems Agency (HSA) initially projected scanner demand on institutional usage showing the sum of nuclear brain scans, cerebral angiograms and pneumoencephalograms performed is at least 1,000. This requirement was based on the rationale that an institution performing 1,000 of these three head procedures can expect to generate some 1,900 total head and body scans each year (Exhibit 8). A survey of the Mt. Sinai procedures conducted before and after the installation of a CAT-Scanner cast serious doubts on the validity of these assumptions (Exhibit 8) and HSA increased the institutional procedures required for justification of need to 1,500. However community need and not institutional need is the criteria required to support an application for a certificate of need. In support of its position that the decision of HSA and HRS to recommend denial of petitioner's application for a certificate of need was arbitrary and unreasonable, petitioner called four witnesses. The first witness, a diagnostic radiologist, lives and works in Leon County. The scanner at Tallahassee Memorial Hospital is in operation 14 hours per day and in 1976 some 2,850 procedures were performed. He has never used a body scanner and is not familiar with the need for additional machines in Dade County. Petitioner's second witness was a diagnostic radiologist attached to the staff at North Miami General Hospital. He believes that CAT-Scanners should be readily available 24 hours per day in all hospitals of a size at least comparable to North Miami General. The nearest machine to North Miami General is located at Miami International Hospital and is owned by a group of physicians. He does not consider the quality of scanning procedures done at this hospital is up to the highest standards and is reluctant to send patients there. No reports of unsatisfactory procedures have been made by him. In 1976 North Miami General referred only 250 to 300 patients to other hospitals for scanning procedures. Referrals are usually made to Mt. Sinai Hospital, Palmetto General Hospital, and Miami International Hospital. One objection voiced respecting the latter is the requirement that patients pay in advance for the procedure. At North Shore Hospital a physician-owned scanner is in service. North Shore Hospital, Miami International Hospital and Parkway General Hospitals are in reasonably close proximity to North Miami General. Parkway General is across the street from Miami International and commenced operating its body scanner in January, 1977. The Executive Vice president and Executive Director of petitioner also feels his hospital needs a CAT-Scanner so one will be readily available for use by patients needing the procedure. Petitioner has entered into negotiations with St. Francis Hospital to participate in the use of their scanner, but to date have not reached a participation agreement. The scanner at St. Francis Hospital, if present, is not included with the nine machines reported to be in use or the five on order. The estimates of projected use submitted with petitioner's application he considers to be conservative. The fourth witness called by petitioner was the official of HRS who prepared the letter denying the application for certificate of need. His function is to evaluate the need for capital expenditure for projects such as CAT scanners. In evaluating the need for the requested machine here involved the number of scanners presently in use was ascertained with the usage to which they are put. To this is added the scanners for which approval has been granted and ordered as well as those on order for which certificate of need has not been requested. In reaching the decision to deny approval of this application HRS relied heavily on the evaluation made by HSA and the review council both of which recommended the application not be approved. Numerous criteria, including the number of additional machines approved and on order for installation in Dade County, were considered by HRS, literature on the subject was reviewed, usage data of existing machines was obtained, discussions were held with doctors utilizing the procedure and a minimum reasonable usage of 200 scans per month, or 2,400 scans per year, per machine was established as the crucible upon which applications for additional certificates of need would be tested. Using these criteria HRS followed the recommendation of HSA. Determination of need was predicated upon the criteria contained in 42 CFR 51.4. In relating those criteria to this application HRS considered the service area appurtenant to applicant and on the date denial letter (Exhibit 6) was forwarded to petitioner three facilities in this service area, viz Mt. Sinai, Miami International, and North Shore General Hospital were equipped with CAT-Scanners and Parkway General had an application approved with installation pending. Community need, rather than the institutional need criteria developed by HSA was utilized. The primary basis for HRS' denial of the application was two CAT- Scanners in the vicinity of North Miami General were not being utilized at or reasonably near the minimum determined usage of 2,400 procedures per year and an additional scanner had been approved for installation at Parkway General. Respondent presented two witnesses, the senior health planner for HSA and the official in charge of issuing state certificates of need for HRS. In making the recommendation to disapprove the application here involved HSA considered the number of scanners installed and approved in Dade County plus those on order and the current utilization of the scanners in Dade County. Also considered was the nationwide usage data and number of scanners contained in the office of Technical Assessment draft report prepared at the request of the U. S. Senate (Exhibit 16). The procedure used to ascertain the minimum usage requirement of 2,400 procedures per year was to discuss with the doctors operating "CAT" Scanner the operation of the scanner at the hospitals using them to determine the average number of scans performed, then review the literature extant on the subject to obtain cost/usage figures throughout the U.S.
