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DAVID J. NORMANDIN vs FRESENIUS MEDICAL CARE, 09-004943 (2009)
Division of Administrative Hearings, Florida Filed:Shalimar, Florida Sep. 11, 2009 Number: 09-004943 Latest Update: Feb. 09, 2011

The Issue Whether Petitioner was the subject of an unlawful employment practice based on his disability by Respondent.

Findings Of Fact Respondent, Fresenius Medical Care, provides dialysis treatment to end-stage renal disease patients. During the time relevant to this proceeding, Respondent operated 11 clinics in the Northwest Florida and South Alabama area. The Florida clinics were located in Pensacola, Navarre, Destin, Fort Walton Beach and Crestview. The South Alabama clinic was located in Andalusia. “Dialysis” is the cleansing of the body of unwanted toxins, waste products, and excess fluid by filtering the blood of patients through the artificial membrane of a dialysis machine. Purified water and dialysate are used during the process. Dialysis treatment is necessary when a patient’s kidneys are inadequate or no longer capable of acting as a filter to remove waste and fluids from a patient’s blood. While the frequency of treatment can vary for each patient, patients typically received dialysis at Fresenius’ clinics three times a week for four hours. The treatment requires piercing the skin and blood vessel so that each patient is intravenously attached to a dialysis machine. Because dialysis involves piercing the skin and blood vessels, as well as the removal and replacing of a person’s blood, patients are at an increased risk of infection. In order to protect patients from infection, proper maintenance, testing, and sanitation of the equipment used during dialysis is of primary importance. As such, dialysis is highly regulated by state and federal agencies responsible for health, safety, privacy, and reimbursement for health care. In order to fulfill its obligations to its patients and regulators, Fresenius maintained a Code of Business Conduct that outlined policies and procedures which every employee was required to follow. These policies and procedures were based on federal regulations enforced by the Centers for Medicare and Medical Services (CMS). The Code required that maintenance, sanitation, and tests for contaminants be regularly performed according to the schedules established for such procedures. The Code of Business Conduct also required all of Respondent’s employees to maintain accurate and complete records. In particular, biomedical equipment technicians were required to maintain logbooks of all the maintenance and tests done on each piece of equipment used in the dialysis process. Documentation was required to ensure that state and federal reporting requirements for maintenance and testing on dialysis machines was done. Documentation of every task performed by a biomedical technician was also required for review by Respondent’s internal and external auditors. Failure to perform these functions could subject Respondent to fines and other government actions, including loss of its Medicare certification and a shutdown of its clinics. Respondent also maintained a “Continuous Quality Improvement” (CQI) program which was designed to review indicators of the quality of treatment Respondent’s patients were receiving. These quality measures were reviewed by a CQI committee. The CQI committee was an interdisciplinary team consisting of the Medical Director, the doctor responsible for overseeing the medical care provided in a clinic; the Area Manager, the person responsible for managing all aspects of a clinic’s operations; the Clinical Manager, the registered nurse responsible for nursing care and technical services at a clinic; and the Biomedical Technician, the person responsible for maintaining, sanitizing, and testing the dialysis equipment at a clinic. Periodic meetings were held by the CQI committee to review all aspects of dialysis at a clinic. The periodic meetings included a review of machine maintenance, machine sanitation, and culture tests done on dialysis machines at a clinic, as well as a review of logbooks maintained by the biomedical technician, if necessary. The periodic meetings also included a review of all adverse events and all patient incidents that occurred at a clinic. Additionally, to ensure quality dialysis services, all of Respondent’s employees received initial and annual compliance training, which addressed relevant changes to Respondent’s policies, as well as state and federal laws. Petitioner, David J. Normandin, was a certified Biomedical Equipment Technician and nationally certified Biomedical Nephrology Technician. Petitioner received extensive training as a Biomedical Technician, including training on national standards for nephrology technicians and national protocols for testing, maintenance, and documentation of these efforts. Additionally, Petitioner received both initial and annual on-the-job training from Fresenius regarding required maintenance, sanitation, and record-keeping responsibilities. Petitioner worked for Respondent on two separate occasions. Initially, he worked at one of Respondent’s clinics in North Carolina, where he was a Chief Technician. Later, Petitioner moved to Florida and was employed by Renal Care Group as a Biomedical Technician. Eventually, Renal Care Group was purchased by Respondent in April 2006. After the purchase, Petitioner remained employed with Respondent as a Biomedical Technician until his termination on February 6, 2008. As a Biomedical Technician, Petitioner was assigned responsibility for three clinics. Petitioner’s responsibilities included providing preventive maintenance, troubleshooting, repairing, cleansing, and disinfecting of the clinic’s dialysis machines and water treatment equipment. His responsibilities also required taking water cultures and testing the water systems to ensure that the equipment and water were free from bacterial growth and pathogens. Without such maintenance, sanitation, and tests, it was dangerous for a patient to be intravenously hooked up to a dialysis machine that had not been properly tested or maintained. Every patient with whom the dialysis equipment might come into contact would be affected. Indeed, the consequences of not performing required routine testing, sanitation, maintenance, and record-keeping tasks were serious. At Fresenius’ clinics, Biomedical Technicians worked independently and were assigned to specific clinics. However, Biomedical Technicians assigned to other clinics sometimes helped other technicians when needed to complete their required duties. Such help only occurred if the foreign technician was available and not busy with meeting responsibilities for their own clinics. Petitioner admitted that the other technicians were usually “slammed” with the work at their own clinics and not generally available to help at Petitioner’s clinics. Indeed, the evidence did not demonstrate that other qualified technicians were generally or routinely available to assist Petitioner in his job duties. Similarly, the evidence did not demonstrate that it was reasonable for Respondent to hire additional technicians to help Petitioner perform his job duties. Petitioner was required to provide a monthly summary or technical report to the CQI committee for each clinic to which he was assigned. As part of the report, Petitioner was required to self-report what maintenance and tests were completed, and what maintenance and tests remained to be completed at each clinic. Petitioner was also required to self- report if he was behind in the performance of his routine job duties so that help might be provided, if it was available. If Petitioner failed to properly report any compliance deficiencies, such deficiencies would not normally be discovered until the Regional Technical Manager, Todd Parker, conducted an internal audit of the clinic or an unannounced CMS survey was performed. When he was initially hired by Respondent, Petitioner was responsible for the clinics in Fort Walton Beach, Crestview and Andalusia. At times, Petitioner assisted in or was responsible for the maintenance of two additional facilities in the area. These additional assignments generally occurred when Respondent was understaffed or training new staff. However, by April or June 2007, Petitioner was only responsible for the three clinics in Fort Walton Beach, Navarre, and Destin. The evidence did not show that Petitioner was responsible for more clinics than any other Biomedical Technician. Joan Hodson was the Clinic Manager for Respondent’s Fort Walton Beach clinic. As of April 2007, Petitioner’s direct supervisor was George Peterson, who in turn reported to Mr. Parker. Joan Dye was the Area Manager. Petitioner testified that he informed his employer in 2003 that he had a bad back. Petitioner admitted that he continued to perform his job duties without significant difficulty. There was no evidence that demonstrated his complaints were more than ordinary complaints about a sore back or that such complaints rose to the level of or were perceived as a handicap by his supervisors. However, sometime in 2007, Petitioner was diagnosed with two herniated discs and began having difficulty keeping up with his job duties. In March 2007, Petitioner was the on-call technician for emergency calls from the clinics in the area. He did not respond to several calls from the area clinics. These clinics complained about the missed calls to Ms. Dye and Mr. Parker during the March CQI meeting in Pensacola. As a consequence, Ms. Dye and Mr. Parker called Petitioner into the office to discuss the missed calls and to address the issue that his work was falling behind. They asked Petitioner if there was a problem. At the time, Petitioner was not under any medical restrictions from a healthcare provider. Petitioner informed Ms. Dye and Mr. Parker that he was on medications for his back which caused him to sleep very deeply and not hear the phone ring when clinics called. He also told them that he was having a hard time keeping up with his work because of the pain from his back. As a result of the meeting, Petitioner was taken off “call” duty and was no longer responsible for responding to other clinics’ calls for assistance. Petitioner was also informed that he would be provided help when it was available so that he could catch up on his assignments. Additionally, Petitioner was asked to provide a doctor’s note concerning his back condition and any limitations he might be under due to his back. This meeting was the first time Petitioner informed his employer that he had a serious back problem. On April 24, 2007, Petitioner provided Respondent with a doctor’s note concerning his back. The doctor’s note stated that for two months Petitioner was not to lift over 30 pounds, and was not to engage in repetitive bending, stooping, or kneeling. Petitioner was released to full duty on June 24, 2007. This is the only doctor’s note Petitioner ever provided to Respondent. Importantly, these restrictions did not impair Petitioner’s ability to document all of the jobs he had performed or to accurately self-report when specific maintenance and tests were not done or were behind. On October 3, 2007, Mr. Parker performed a technical internal audit of the Navarre clinic which was assigned to Petitioner. At the time, Petitioner was responsible for the Navarre clinic. The audit revealed that Petitioner had performed no dialysis and end toxin testing for the clinic during the year. These tests were required to be performed every six months. Moreover, Petitioner failed to disclose to anyone that he had not performed these tests even though he had the opportunity to self-report during CQI meetings or at any other time. Again, Petitioner met with Mr. Parker and Ms. Dye. When asked to explain why the tests had not been performed at the Navarre clinic, Petitioner told Mr. Parker and Ms. Dye that he “did not know” he had to do them, and that he had simply “misunderstood” the requirements. Petitioner’s claim was not credible. His supervisors found Petitioner’s explanation to be suspect, since he had previously completed dialysis and end toxin testing at both Navarre and the other clinics he was responsible for. In a memo he later prepared as to why he had not conducted the tests, Petitioner wrote: “so much to do, so far behind.” Petitioner never mentioned his back as an excuse for why he had not performed the tests in his meeting with Ms. Dye and Mr. Parker. At the hearing, Petitioner admitted that he simply “forgot” to conduct the dialysis tests. Clearly, Petitioner’s failure to perform his duties was not related to his back. Similarly, his failure to self-report with any specificity was not related to his back. Ms. Dye instructed Petitioner to complete the test samplings for the clinic that day. Ms. Dye also instructed Petitioner to maintain samplings per the policies at all of his clinics going forward. Petitioner also was instructed by Ms. Dye that he had to immediately test all of the machines at the Fort Walton Beach and Destin clinics for which he was responsible. Petitioner asked Mr. Parker for assistance in catching up on the dialysis testing at the Navarre clinic. Mr. Parker came to the clinic and performed half of the tests, while Petitioner performed the remainder. In November 2007, Petitioner saw a surgeon for his back and, for the first time, was specifically informed by a physician that he would need back surgery. It was anticipated that the surgery would be performed sometime after the first of the year. Petitioner told his employer about his need for surgery. They encouraged Petitioner to do whatever he needed to do to take care of his health, and take any necessary time off. Petitioner chose to continue to work. A CQI committee meeting for the Fort Walton Beach clinic was scheduled for Thursday, January 24, 2008. Prior to the meeting, Joan Hodson, the Clinical Manager for the clinic, asked Petitioner to meet with her early in the morning to review the clinic’s dialysis culture logbook. Petitioner missed the meeting and arrived after noon, with no explanation. He told Ms. Hodson that all cultures were good. Later, at the CQI committee meeting, Petitioner reported to the Medical Director, Dr. Reid, that all the cultures looked good. In reviewing, the printout report for the cultures, Dr. Reid noticed that one of the samples was high and asked that it be redrawn. Petitioner told Dr. Reid and the committee that he had already performed a redraw. He left the meeting to go get proof of the redrawn results. Petitioner’s claim that he did not tell the committee that he had already redrawn the culture and had the results is not credible. Petitioner left the CQI meeting and never returned. Later, Petitioner admitted he had not redrawn the sample. He was instructed to redraw the sample immediately. The day after the CQI meeting, Ms. Hodson called Petitioner asking for the redraw results. Petitioner still had not performed the redraw claiming that he was “too busy.” He was again instructed to immediately perform the redraw. Ms. Hodson called Petitioner the following day, inquiring about the redraw, but did not receive a return call. That weekend, Mr. Parker also called Petitioner to ensure that the redraw was done or would be performed immediately. During the call Mr. Parker informed Petitioner of the seriousness of his failure to redraw the culture immediately as he had been instructed to do and the inappropriateness of his actions regarding the culture before, during, and after the CQI meeting. Mr. Parker also instructed Petitioner to call Ms. Dye about the redraw results. Petitioner again did not perform the redraw as instructed. Ms. Dye also left Petitioner a voicemail to call her about the redraw. Petitioner never called Ms. Dye back. Petitioner’s repeated and willful failure to comply with his supervisors’ instructions was not related to his back. On January 30, 2008, as a consequence of Petitioner’s failure, Petitioner was relieved of his duties for the Destin clinic. He was also given a written warning in a Corrective Action Form (CAF), based on the incidents from January 24, 25, 26, and 28, 2008. The CAF specified “Expectations for Change,” which identified problems with Petitioner’s performance. Ms. Dye reviewed the CAF with Petitioner and instructed him that these problems had to be addressed immediately. These expectations included: Perform all culture draws according to FMC Technical Manual and review this with the Clinical Manager. Immediately report any cultures that are outside the FMS limits and any redraws to the CM. . . . When Dave is at the clinic, he will be expected to redraw any culture that day, if necessary; At CQI monthly meetings, will ensure that all cultures are reported correctly and proper protocol is followed. A Technical CQI summary monthly report and a Spectra monthly summary culture report must be presented to the CM and MD for review and signature; Implement a basic monthly schedule and submitted to his CM’s by the 1st day of each month, will ensure that if he is not at a specific location according to his schedule, he will contact the CM or the Charge Nurse of that clinic to inform them of his location. If called or paged by any clinic, or a member of management, he must respond within 15 minutes from the time he received the call or page; Will follow a more systemic time schedule and will incorporate his time with his monthly schedule. Will make himself readily available to be present, if one of his clinics develops a problem in the early morning hours, if necessary; and When on-call, the 15-minute rule also applies. If not on-call, no matter which clinic calls, will return the call or page and assist the clinic, inform them who is on-call and/or attempt to resolve the problem over the phone. That same day, January 30, 2008, Petitioner received a Developmental Action Plan from Mr. Peterson. Five goals and an Action Plan were identified that Petitioner had to meet within time frames set during the next 90 days. Goals in the Plan included incorporating all of his monthly cultures into the FMC (Fresenius Medical Care) logbook and developing a basic monthly preventive maintenance culture and disinfect schedule for all facilities. By March 31, 2008, the Technical Manager would evaluate and review the goals accomplished by Petitioner to determine if further action was necessary. Petitioner admitted that although he had been obligated to self-report all of the deficiencies in the Corrective Action Form at the CQI meeting in January 2008, he failed to do so. Petitioner testified that he told Ms. Hodson that he was “very much behind” on performing his job duties. He also admitted that he never provided her with any specifics as to the tasks he had not performed. Additionally, he admitted that, “I don’t even know all of the things that I was behind on” and “I don’t know which [logbooks] I’m missing.” The internal audit at the Fort Walton Beach clinic and Petitioner’s actions regarding the redraw of the culture caused Ms. Dye to be concerned about the integrity of the job Petitioner was performing at all three of his clinics. Based on Petitioner’s lack of honesty with the CQI committee, Ms. Dye was legitimately concerned that Petitioner was covering up his failure to do his work and that the safety of patients was at risk. As a result, Mr. Parker performed an audit of the Fort Walton Beach clinic on February 6, 2008. The audit revealed that no dialysate cultures had been performed since October 2007; two out of 31 machines lacked proper documentation of any preventive maintenance having been performed; no preventive maintenance logs were available for the building maintenance and ancillary equipment; two new machines had no documentation; and no electrical and safety checks had been performed since April 2007. All of these tasks were required to have been completed by Petitioner, and Petitioner’s failure to complete them was a serious violation of his job duties. Indeed, these deficiencies placed the Fort Walton Beach clinic in immediate jeopardy of being fined and shut down by CMS. A shutdown would have left 80 of Respondent’s patients without dialysis treatment and placed them at risk for illness and possibly death. The audit also uncovered that the written summaries Petitioner had submitted to the CQI committee in October, November, and December 2007, and the verbal reports he had given to the committee at those monthly meetings, indicating that the preventive maintenance logs were up to date, were in fact incorrect. Again, Petitioner’s failure to document was a serious violation of Petitioner’s job duties and was not related to his back condition. By this time, Ms. Dye had legitimately lost all faith in Petitioner’s honesty. She suspected that Petitioner had falsified certain records because he could not produce various records when he was asked to produce them and only later did the requested records appear. In short, Petitioner’s supervisors had lost faith in Petitioner and could no longer trust him to self-report or to inform others when his duties were not being performed. On February 6, 2003, Ms. Dye presented Petitioner with a second Corrective Action Form, noting the issues generated by the internal audit and suspending Petitioner from work. The CAF was reviewed and signed by Petitioner. Based on what was discovered from the Fort Walton Beach clinic audit, Ms. Dye ordered an audit of Petitioner’s other clinics, Navarre and Destin. The same issues and deficiencies were discovered at those clinics: 1) the dialysate cultures at the Navarre and Destin clinics had not been performed since October 2007; 2) no safety checks had been performed on four out of 18 machines at the Navarre clinic, and none had been performed at the Destin clinic since July 2007; and 3) preventive maintenance was late on five machines at the Navarre clinic and six at the Destin clinic. The audit confirmed once more that Petitioner had misled the CQI committee members during the January CQI meetings for those clinics by not reporting in his written summary or verbal report any deficiencies. In addition, although Ms. Dye had instructed Petitioner just the week before to immediately perform dialysate cultures at all of his clinics, Petitioner had failed to perform any of those cultures and ignored the instructions of his supervisors. Petitioner was given a final Corrective Action Form by Ms. Dye on February 8, 2008. Ms. Dye reviewed the audit results with Petitioner, as well as the Corrective Action Form, which he signed. Petitioner was terminated the same day. Petitioner was fired after being on the Developmental Action Plan for one week because he had misled the CQI committee in his reports, failed to self-report the extent of the job duties he had not performed to the committee, and had not performed any testing of his dialysate cultures and electrical safety checks or reported that he could not perform those tasks. Such reporting was not related to Petitioner’s back condition. Moreover, misleading the CQI committee was not related to any back condition Petitioner had. Both were egregious and terminable offenses by Petitioner. After Petitioner was terminated in February 2008, he applied for unemployment compensation and for multiple jobs. He never informed any prospective employer that he was disabled or needed an accommodation. Once he ultimately had surgery in March 2008, Petitioner told Respondent that he was better and could work, and he asked for his job back. Eventually, Petitioner went to massage therapy school, obtained his license, and worked sporadically as a massage therapist. Prior to the hearing, Petitioner completed work as a team leader with the Census Bureau. These facts demonstrate that Petitioner’s back condition was not a handicap. There was no evidence that Petitioner was terminated for a handicap or a perceived handicap, and the Petition for Relief should be dismissed.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Florida Commission on Human Relations enter a Final Order dismissing the Petition for Relief. DONE AND ENTERED this 18th day of November, 2010, in Tallahassee, Leon County, Florida. S DIANE CLEAVINGER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 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, 2010. COPIES FURNISHED: Richard N. Margulies, Esquire Jackson Lewis 245 Riverside Avenue, Suite 450 Jacksonville, Florida 32202 R. John Westberry, Esquire 7201 North 9th Avenue, Suite A-4 Pensacola, Florida 32504 Denise Crawford, Agency Clerk Florida Commission on Human Relations 2009 Apalachee Parkway, Suite 100 Tallahassee, Florida 32301 Larry Kranert, General Counsel Florida Commission on Human Relations 2009 Apalachee Parkway, Suite 100 Tallahassee, Florida 32301

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AGENCY FOR HEALTH CARE ADMINISTRATION vs GULF COAST CONVALESCENT CENTER, 01-004073 (2001)
Division of Administrative Hearings, Florida Filed:Panama City, Florida Oct. 17, 2001 Number: 01-004073 Latest Update: Jan. 10, 2025
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COMPREHENSIVE HOME HEALTH CARE, INC. vs DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 89-004885 (1989)
Division of Administrative Hearings, Florida Filed:Miami, Florida Sep. 05, 1989 Number: 89-004885 Latest Update: Feb. 13, 1990

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.

Florida Laws (1) 120.57
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BOARD OF MEDICAL EXAMINERS vs. RANDALL B. WHITNEY, 82-002577 (1982)
Division of Administrative Hearings, Florida Number: 82-002577 Latest Update: Jul. 03, 1984

Findings Of Fact Respondent, Randall B. Whitney, is a licensed medical doctor having been issued license number ME 000 8859 by petitioner, Department of Professional Regulation, Board of Medical Examiners. He presently resides in Port Orange, Florida and operates a family planning center in Daytona Beach. Respondent is a 1959 graduate of Tulane University Medical College. After interning at a Jacksonville hospital, he served three years in the U.S. Air Force as a flight medical officer and flight surgeon. He then took a two- year general residency in California. He began private practice in Mount Dora, Florida in 1965, the same year he received his license to practice in Florida. Although he was once board certified in family practice, he is not presently board certified in any specialty. He is not a member of the Florida or American Medical Associations and he does not hold privileges on the staff of any hospital. Prior to the initiation of this proceeding he did apply for emergency room privileges at a hospital in Daytona Beach but his application was denied. Therefore, he cannot admit patients to hospitals. When the events herein occurred, respondent had a financial interest in and was medical advisor to the Childbirth Center (CBC) in Daytona Beach. He also provided medical services on a contract basis to the Woman's Health Center (WHC) in Orlando and Holly Hill and the Aware Woman Clinic, Inc. (AWC) in Cocoa Beach. All four are birthing centers where women receive care and treatment during pregnancy and where the actual labor and delivery occur. Additionally, the facilities provide annual check-ups, IUD services, abortions, and advice for birth control. He divided his time between the four clinics, visiting each place one day of the week except the Orlando clinic, which he visited two days per week. In the spring of 1981, respondent became acquainted with one Eric Niederschmidt, an enlisted man stationed at Patrick Air Force Base who also worked weekends or nights at Aware Woman Clinic as an "assistant". Eric complained of pain in his knee from an internal knee derangement caused by stress and requested a pain medication to ease the pain. Whitney wrote several prescriptions for percocet between March and September, 1981. He also permitted Eric on several occasions to fill out the prescription pad, then bring it to him for review, and then sign the prescription. The evidence is conflicting as to whether respondent kept pre-signed blank prescription forms at the Aware Woman Clinic, which were later used by Niederschmidt to obtain drugs. Although respondent admitted he pre-signed such forms to a Department investigator during an interview in November, 1981, he denied he did so during the final hearing, and it is found the greater weight of credible evidence supports a finding that he did not. The CBC is not equipped to handle emergency situations or to care for "high-risk" pregnancies. Instead, it is designed to handle the routine low-risk pregnancy which has no complications. Indeed, the CBC has no internal monitoring devices, x-ray equipment or cesarean section devices, all of which are needed when complications in preqnancy set in. Its medical equipment consisted primarily of nitrous oxide and oxygen in large H-cylinder tanks with a nasal applicator mask, a fetal Doptone monitor to monitor for fetal heart tones, an Isolette to provide a controlled environment for babies distressed prior to transfer, outlet forceps, intracoths, emergency suction apparatus and the like. A supply of various kinds of medicine, including adrenalyn, ephedrine and pitocin were kept on hand. In 1979, one Joyce Ann Geeson became a patient of respondent at CBC. She was cared and treated for during her pregnancy in the months of June through a part of December, 1979. Around 3:30 a.m. on Saturday, December 8, 1979, Geeson awoke with ruptured membranes. She did not begin labor until almost 22 hours later. After labor pains commenced that night and early Sunday morning, Geeson reported to the CBC at noon on Sunday. After 38 hours of labor with little progress, Whitney ordered that pitocin be administered to Geeson. That drug serves to stimulate contractions of the uterus. However, this drug should only be used in a hospital setting since it can cause a tetanic contraction of the uterus and cut off the blood supply to the baby. It can also cause a rupture of the uterus. Therefore, it was inappropriate for Whitney to use pitocin in his facility. This is confirmed by instructions in the Physicians Desk Reference, 1979 edition, as to the use of the drug as well as uncontradicted expert testimony presented by petitioner. In Geeson's case the pitocin was continued for some 18 hours until a decision was made to transfer the patient to a hospital after the patient had made very little progress. Geeson was finally admitted to the emergency room at Halifax General Hospital around 11:10 p.m. on December 10, 1979. Whitney accompanied her to the hospital. When Geeson's temperature rose to 102.3 around 6:00 a.m. on December 11, she was immediately sent to the operating room where a C-section was performed. An examination of Geeson indicated her membranes had been ruptured for approximately 68 hours prior to admission to the hospital, that the patient had given signs of such a rupture by the excretion of a green tinged fluid (meconium), and that Geeson had stopped progress in delivering the baby some 24 hours prior to the hospital admission. Whitney's failure to recognize and properly handle premature rupture of the membranes, to promptly repond to meconium staining (which is a sign of possible fetal distress), and the use of pitocin in a non-hospitaL setting were deviations from the level of care, skill and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. Sandra Vigue was a 33 year old patient of the CBC in the fall of 1979. She first visited the clinic in her third trimester in September, 1979. Vigue told CBC personnel that her last menstrual period was mid-December, 1978 which would have indicated an expected date of confinement (EDC) of mid or late September, 1979. The clinic initially noted her EDC as being late September or early October. A nurse later noted in the records that on September 19 the patient was approximately 35 weeks gestation, or 5 weeks before the due date. When the baby had not come after weekly visits to the clinic in October, a nurse simply placed a question mark next to Vigue's EDC. By this time (42 weeks), according to expert medical testimony the fetus comes at high risk because of post-maturity syndrome. On October 21, 1979, Vigue began labor around 7:00 p.m. Around 8:30 p.m. a nurse noted the presence of a greenish substance being discharged in the vaginal area while performing an examination at Vigue's home. She noted in the patient records that it had the appearance of meconium. The nurse immediately telephoned respondent to report this finding. After a discussion, Whitney discounted the fluid as being cervical and not meconium. Meconium is, of course, an indication of fetal distress and that a membrane has prematurely ruptured. This in turn leads to a high-risk situation in terms of the delivery of the baby. Vigue remained at her home overnight and had no apparent progress in contractions. At approximately 1:00 p.m. the next day (October 22) Whitney requested she come to the clinic. She did so and was evaluated by him at 4:00 p.m. Whitney noted the passing of copious malodorous meconium and asked "why" in the charts. He then sent her to a local hospital where she was admitted at 7:50 p.m. the same day. Upon examination by hospital personnel, they noted premature rupture of the membranes and a discharge of meconium. Before further tests could be run, Vigue's condition deteriorated and she was given an emergency cesarean section. A stillborn infant was delivered. Respondent performed no post-maturity syndrome tests on Vigue that are normally given when a woman reaches an age of 42 weeks pregnancy. These tests are essential since a baby at that age may be under stress from lack of nutrients and oxygen. In this regard, he failed to conform to prevailing community standards for physicians. Vigue was apparently quite firm in not wanting her baby delivered in a hospital setting. However, a physician should advise the patient when high risks set in of the potential danger in not doing so, and if the patient refuses, document his records accordingly. Here, Vigue apparently held off until the last possible moment, but Whitney did not adequately document his records to show that he advised her of the potential dangers. Again, he failed to meet acceptable standards of skill, care and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. But since this was not a charge within the complaint, it is irrelevant. Finally, Whitney was negligent in the same respect by failing to recognize the meconium staining that occurred on October 21 and asking the patient for a history of rupture of membranes. In July, 1979, Lida Papa became a patient of CBC. Her estimated date of delivery had been established by CBC personnel as December 11, 1979. Papa suffered a ruptured membrane at 3:00 a.m. on December 22, 1979 or three full days prior to being admitted to a hospital. Her labor commenced on December 23. Because of slow progress, Whitney began administering pitocin to Papa around 7:25 p.m. on December 23 at a rate of 8 drops per minute, or a rate of 2 to 3 times that used initially in a hospital setting. The administering of the drug continued in larger dosages until the afternoon of December 24 when he allowed her to rest. It was restarted at 9:30 p.m. that evening and continued until 11:30 p.m. At the same time, the patient records of Papa reflect signs that the baby may have been in distress. She was also given ampicillin, presumably to counteract chills and fever being experienced around 1:30 a.m. on December 25. When her temperature reached 101 degrees Papa was sent to Halifax Memorial Medical Center, a Daytona Beach hospital. It was noted there that Papa had been at 9 or 10 centimeters dilation for some 18 to 19 hours prior to being transported to the hosptial. This is equivalent to complete dilation, and babies are normally delivered within two hours after complete or near complete dilation. Prudent medical care would have dictated that Whitney transfer Papa to the hospital no later than 24 hours after the membranes were ruptured if delivery had not occurred or was not imminent. This would have required admission to the hospital on December 23 rather than December 25. Whitney was also negligent in using pitocin in a non-hospital setting, and in dosages higher than is normally used. But this conduct was not described within the complaint and accordingly is irrelevant. Whitney failed to recognize that the patient was at high risk in a non-hospital setting because of the use of pitocin and the prolonged rupture of the membranes. In these respects, he deviated from the level of care, skill and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. Whitney was employed by the Women's Health Center, Inc. (WHC) in Orlando, Florida on a contract basis in 1978. He generally visited the Center either on Tuesday and Thursdays of each week, or Thursday only, depending on his schedule at other clinics. Whitney did not represent himself to the Center as being a urologist although he routinely performed vasectomy procedures. Daniel Hallman wished to have a vasectomy performed, and after searching through the Yellow Pages, selected the WHC. He talked by telephone with an unidentified lady at the Center and asked if the physician who would perform the vasectomy was a "licensed urologist." He was assured that Whitney was. Hallman then made an appointment to have the procedure performed on Thursday, November 16, 1978. On that afternoon, he visited the Center where he first saw a film on vasectomies which briefly touched on complications, procedures and care of patients. He had some preliminary work performed by a nurse and then met with Whitney. He was never advised by Whitney of the risks associated with the operation or complications that could result from the procedure. Whitney testified that although he normally counseled patients, he thought Hallman had "waived counseling in effect" because he was intelligent and seemed to be well-read on the subject. Whitney was not asked nor did he represent to Hallman that he was a "licensed urologist." After the procedure was performed, Whitney told Hallman he could not ride a bicycle to work for awhile and to avoid intercourse for several days. He did not tell him that swelling, bleeding and fever could occur. Hallman left, went home, slept and then awoke later that night with pain, swelling and bleeding. He called the Center and a nurse advised him to apply ice to stop the bleeding. He did so and went back to sleep. Later on, he awoke in extreme pain and noticed his scrotum had swollen to the size of a grapefruit. He again called the clinic asking for Whitney but was told Whitney lived in Cocoa Beach and was unavailable. The nurse told him to keep applying ice and he would be okay. When Hallman called a third time on Friday morning, the clinic then contacted Whitney who returned Hallman's call later that morning. Whitney told him he could see him if Hallman would drive to Cocoa. Whitney did not recommend he see another physician since he had no "back-up" in the area. Whitney advised Hallman to continue to apply ice and to see him when he visited the Center the following Tuesday. The following Tuesday, the two met and Whitney prescribed a pain killer (darvon), clipped a stitch and squeezed some dry blood out of the area. He noted it was the worst case of swelling he had ever seen. He also advised Hallman to take warm baths. The two never met again. When the pain killer became ineffective, Hallman contacted a urologist the following Saturday who treated him at the emergency room of an Orlando hospital. The physician found Hallman to have a low-grade fever and prescribed an antibiotic and pain killer. When the procedure was performed, Whitney had no local hospital privileges or a "back-up" physician to handle emergencies. Whitney testified he had no post-operative information to give to Hallman to read. He attributed the problem to a "nicked" varicose vein and stated that he has performed approximately 1,000 such operations routinely since 1965 without a patient ever being hospitalized. Had he considered there to be a danger of infection, he would have referred Hallman to an emergency room. Because Whitney had no back-up physician for Hallman to see should post-operative complications have arisen, he failed to meet the standard of care practiced by similarly prudent physicians in the community. The administrative complaint does not allege, and indeed there is no evidence, that the procedure was improperly performed. Respondent has safely delivered at least 1,000 babies during his medical career. He believed that Vigue, Papa and Geeson were carefully monitored and treated, and were timely transported to the hospital once their risk factors had escalated. In the case of Hallman, Whitney stated he would have seen the patient had he realized an emergency existed, and admitted him to an emergency room if necessary. He justified the use of pitocin on the grounds it was safely administered and the Physicians Desk Reference is not binding on physicians in all cases. Whitney no longer performs childbirths and is not associated with any of the clinics in question. Instead, he now confines his practice exclusively to family planning.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Subsection 458.331(t), Florida Statutes, on four occasions as more specifically set out above, and that his medical license be suspended for thirty days, a $2,500 administrative fine imposed, and that he be restricted from performing childbirths except in a hospital setting. All other charges should be dismissed. DONE and entered this 20th day of April, 1984, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of April, 1984. COPIES FURNISHED: Douglas P. Jones, Esquire John M. Bringardner, Esquire P.O. Box 2174 Tallahassee, Florida 32316 Jack R. Leonard, Esquire 800 North Highland Avenue Suite 202 Orlando, Florida 32803 Frederick M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301

Florida Laws (2) 120.57458.331
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DEPARTMENT OF HEALTH vs TERRY D. KOUBEK, M.D., 07-002319PL (2007)
Division of Administrative Hearings, Florida Filed:Palm Bay, Florida May 23, 2007 Number: 07-002319PL Latest Update: Jan. 10, 2025
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ST. MARY`S HOSPITAL, D/B/A ST. MARY`S PSYCHIATRIC PAVILLION vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 86-004354 (1986)
Division of Administrative Hearings, Florida Number: 86-004354 Latest Update: Oct. 07, 1988

Findings Of Fact Harbour Shores is a 60-bed psychiatric facility located in Fort Pierce, St. Lucie County, Florida. Harbour Shores began operation in October, 1985, pursuant to licensure as part of Lawnwood Regional Medical Center, a general acute care hospital. Harbour Shores is located near Lawnwood Regional Medical Center and functions as a part of that hospital. Lawnwood Regional Medical Center, Inc., is a wholly owned subsidiary of Hospital Corporation of America (hereinafter "HCA"), a private, for-profit corporation. HCA Psychiatric Company manages and provides services to Harbour Shores pursuant to a management agreement. HCA Psychiatric Company has experience owning and/or operating approximately 54 psychiatric facilities, with 6,000 beds, nationwide. Services provided by HCA to Harbour Shores include a quality assurance surveying process to assure that the HCA facilities maintain high standards of care, continuing education and training seminars, professional staff including psychiatrists available to assist the individual facilities, computer services, and bulk purchasing. The Harbour Shores 60-bed psychiatric facility is divided into two patient care units: a 24-bed adolescent unit and a 36-bed adult unit. Within the adult unit, Harbour Shores operates three distinct patient care programs: a therapeutic community open unit for higher functioning adult psychiatric patients, a senior adult program for elderly adult psychiatric patients, and an intensive treatment or acute care program for lower functioning, violent, or suicidal psychiatric patients who are in need of closer monitoring and more intensive treatment than the other higher functioning patients. All of the Harbour Shores beds fall in the short-term inpatient psychiatric category, with an average length of stay of three to four weeks. The Harbour Shores facility is well-designed for the treatment of psychiatric patients. It is a one-floor design, with admissions and administrative spaces upon entry, the two separate patient care units for the adults and adolescents, each with separate entry, and ample program and activity space. Harbour Shores has a gymnasium, classrooms for the adolescents, occupational therapy and activities therapy rooms, seclusion rooms in each patient care unit, dining room and outpatient areas. There are courtyards and a swimming pool, outside of the patient care areas. All of these areas play an important clinical role in the treatment of the psychiatric patients. For example, the gymnasium has a basketball and volleyball court and exercise equipment such as punching bags. These activities are useful for getting rid of aggression in socially acceptable ways, instead of through physical confrontations. The activities and occupational therapy rooms, including a greenhouse, provide opportunities for development of job and social skills. Harbour Shores is located in a pleasant, professional neighborhood, without security or crime problems that could hinder therapy of patients and the ability or willingness of family or others to visit and participate in therapy. Harbour Shores' relationship with Lawnwood Regional Medical Center provides benefits to the psychiatric patients who need medical services not normally offered in a psychiatric hospital. Harbour Shores is able to quickly transport a psychiatric patient to the acute care hospital for emergency room care, if necessary, or for diagnostic laboratory services. Harbour Shores and Lawnwood Regional Medical Center have a single medical staff, and a full array of medical specialists other than psychiatrists are available for consultation at Harbour Shores. Harbour Shores seeks to provide a full continuum of care to its psychiatric patients. This goal is accomplished by the provision at Harbour Shores of a full array of short-term inpatient psychiatric services and also outpatient services. Harbour Shores also has in place transfer agreements for when the psychiatric facility or the Lawnwood acute care hospital are not appropriate for a patient, including an agreement with HCA Medical Center of St. Lucie and Indian River Estates in Vero Beach, a nursing home. The typical adult patient coming to Harbour Shores generally goes through an admissions process first for screening to determine whether inpatient treatment, instead of outpatient care, is necessary. The patient and family are given an overview of the program, and then the patient is taken onto the unit where the initial nursing assessment is performed, usually by the charge nurse. The attending psychiatrist sees the patient within 24 hours of admission, and the preliminary treatment plan is formulated. That plan is revised in three days, based upon information gathered from the family and through observation and treatment. The treatment team who formulate the plan include the psychiatrist, who is in charge of the team, clinical social worker, unit coordinator, the charge nurse or attending nurse, psychologist and mental health technicians. Simultaneous with the formulation of treatment plans, the team formulates and revises the patient's discharge plan. After ten days, a master treatment plan is prepared, comprehensively addressing the patient's problem, changes in the previous treatment plan, discharge plan and follow-up care plan. After the patient is discharged, the psychiatrist will often follow up with the patient on an outpatient basis. Harbour Shores has in place a number of quality assurance monitoring techniques to ensure that it will maintain a high level of quality care for its patients and will improve its care where improvement is possible. Harbour Shores has an ongoing quality assurance committee, and subcommittees, that meet regularly to assess patient care. Harbour Shores has accepted and implemented the recommendations of its committees. There is also a less formal quality assurance mechanism called patient care monitoring, whereby any time a staff member feels that there is a patient care problem, he or she can call up the staff group responsible for that patient, together with a professional not involved in that case, for a review and resolution of the problem. Harbour Shores provides very good overall quality of care to its patients. Harbour Shores' quality care has been formally recognized through its achievement of Joint Commission on Accreditation of Healthcare Organizations (hereinafter "JCAHO") accreditation, a voluntary accreditation process based on many standards judged through formal surveys and information gathering. JCAHO accreditation is recognized as the standard in the industry. Harbour Shores has also been awarded membership in the National Association of Private Psychiatric Hospitals. Like JCAHO, it requires a facility to undergo a quality assurance survey. Becoming a member demonstrates a level of quality of a facility that is well-recognized in the industry. One result of the careful monitoring of patient care at Harbour Shores was the recognition early on in its operation that the general open adult unit was not serving the combined needs of higher functioning and intensive treatment patients in the most beneficial way possible. The difference between general short-term psychiatric care and intensive treatment in a psychiatric hospital can be analogized to the difference between an acute care hospital's general medical-surgical care and its critical care. Because of the extra care and monitoring required for the intensive treatment patients, they were consuming the open unit staff's attention to the detriment of the higher functioning patients, and they could also be disruptive and dangerous. The more acutely disturbed patients also tended to become more agitated with the higher levels of stimulation they experienced when they were mixed with higher functioning patients. Therefore, Harbour Shores began taking steps to follow the medical staff's recommendation to separate the two patient populations into distinct subunits. In April, 1986, Harbour Shores filed a certificate of need application seeking approval for an addition of 30 beds to its facility: twelve beds to accommodate a separate intensive treatment unit and eighteen beds for a geriatric unit. At the final hearing, Harbour Shores sought approval of only its 12-bed intensive treatment unit. Harbour Shores did not offer evidence at hearing to support the 18-bed geriatric unit. After submitting its application and before hearing, a period of 26 months, and while its certificate of need application was undergoing preliminary review and the administrative hearing process, Harbour Shores made stopgap changes to address, at least in part, the needs of its patients requiring intensive, critical care. Pursuant to a certificate of need exemption recognized by HRS in October, 1987, Harbour Shores added two patient therapy rooms and one activity room to serve an 8-bed area in which it placed intensive treatment patients. The CON exemption was awarded because the capital expenditure was below the threshold dollar amount that would trigger CON review, and no new beds were being added. That project was an interim measure to relieve immediate problems in treating intensive treatment patients at Harbour Shores, independent of this CON project, although Harbour Shores prudently designed that addition to be convertible to patient rooms in the future. Part of Harbour Shores' proposal under review in this case involves a conversion of the added space to patient rooms, which is why the project is now required to undergo CON review. The addition will continue to serve as non-patient rooms unless and until a CON is granted. The intensive treatment area that has been in operation since January, 1988, does not fully meet the needs of patients at Harbour Shores. While there is now some physical separation of patients and staff, it is not complete. Some of the remaining problems to be addressed include the need for a separate nurse's station, complete with charting area and secure medicine area, a separate seclusion room for the exclusive use of the intensive treatment patients, and direct access to and from the unit without passage through other units. Without a separate nurse's station, the staff cannot be exclusively focused on the intensive treatment unit, and there is incomplete separation of staff. Similarly, without its own seclusion room and direct access, the intensive treatment unit fails to achieve complete separation of patients. The intensive treatment patients now have to pass through the open adult unit to get to their unit and have to leave their unit if they are required to utilize the seclusion room which is on the general adult open unit. This is disruptive to both groups of patients. Utilization of Harbour Shores has been steadily growing since its opening in October, 1985. Harbour Shores has experienced the typical start-up phasing in of patients experienced by psychiatric hospitals. Thus, in 1986, when HRS reviewed utilization at Harbour Shores during 1985, it had only three months of data to consider, and the average utilization was 42 percent. Harbour Shores made progress in 1986, with an average utilization of 60 percent. In 1987, its adult unit achieved a 73.3 percent utilization rate, and it has been holding steady for the first five months of 1988. Harbour Shores has a reasonable expectation that utilization of its facility, especially with respect to intensive treatment services, will materially increase because of its recent designation as a private Baker Act receiving facility. The Baker Act, Part I of Ch. 394, Florida Statutes, is a legal procedure for involuntarily committing someone to a psychiatric facility for treatment. A psychiatric hospital must apply to and be approved by HRS before it can treat Baker Act patients. Designation of facilities to treat Baker Act patients is not a ministerial step, but rather, involves a lengthy application submission and site visit and survey by HRS. Baker Act patients are by definition involuntary, are generally more acutely sick than the voluntary patient, and are proportionately more in need of intensive treatment. HRS District 9 consists of a large geographic area, stretching from Sebastian to the north to Boca Raton to the south, with the Atlantic Ocean as the eastern boundary. District 9 is divided into two subdistricts: subdistrict 1 includes the four northern counties: Indian River, St. Lucie, Okeechobee and Martin; and subdistrict 2 is Palm Beach County. Subdistricts 1 and 2 function primarily as distinct, separate markets for short-term psychiatric care. Harbour Shores primarily serves patients from subdistrict 1, the four- county area surrounding the hospital--St. Lucie County, Indian River County to the north, Okeechobee County to the west and Martin County to the south. Harbour Shores is the only designated private Baker Act receiving facility in subdistrict 1, and it is the only facility with licensed inpatient short-term psychiatric beds that is authorized to treat Baker Act patients. The only other facility authorized to treat Baker Act patients in subdistrict 1 is the Indian River Community Mental Health Center (hereinafter "IRCMHC"), a public receiving facility. The IRCMHC received between 680 and 750 Baker Act patients in 1987. The IRCMHC is not licensed to provide short-term inpatient psychiatric services. It has 15 crisis stabilization beds, which do not serve the same needs as short-term inpatient psychiatric beds. Crisis stabilization beds provide a very short-term service, intended to stabilize emergency patients who are then referred to appropriate facilities. The average length of stay is typically less than one week. The IRCMHC is not a reasonable alternative to provide all needed psychiatric services to Baker Act and other patients, in part because of the limited services that can be provided in crisis stabilization beds, and also in part because the Center is not in very good condition and is in a poor part of Fort Pierce, known for its crime and security problems. When patients or their families have a choice of facilities, it can be reasonably expected that they would choose Harbour Shores. The physical environment of a psychiatric facility plays a role in the patient's therapy, and the Harbour Shores environment is preferable. Until shortly before hearing, another psychiatric hospital in subdistrict 1, the Savannas Hospital, was treating Baker Act patients by referral from the IRCMHC with which it is affiliated, perhaps as many as 5500 patient days in 1987. However, in late May, 1988, the IRCMHC was notified by HRS to cease and desist from referring patients to the Savannas because the Savannas was not approved to serve Baker Act patients; instead, those patients were to be referred to Harbour Shores. Harbour Shores has a working relationship with the IRCMHC, and they receive and give referrals back and forth. As the only authorized Baker Act inpatient psychiatric facility in subdistrict 1, Harbour Shores can reasonably expect to serve those Baker Act patients who were being improperly referred to the Savannas. Harbour Shores' good start-up utilization of its eight intensive treatment beds of nearly 70 percent for the first five months of 1988 indicates the need for those eight beds, with the impact of the Baker Act population first beginning to be realized. Realization of the full Baker Act patient load would overload the intensive treatment unit. If Harbour Shores captures only 50 percent of the subdistrict 1 Baker Act patient market as reflected by the IRCMHC's 1987 patient days, assuming no growth of Harbour Shores' 1987 adult patient census, it would achieve an adult average daily census of approximately 39.8 in the adult (including the intensive treatment) unit, while it currently only has 36 beds. Comparing the quality of Harbour Shores with the IRCMHC, Harbour Shores could capture as much as 80-90 percent of the area's Baker Act patients. Using a conservative 50 percent Baker Act patient projection and projecting no growth of the current adult patient census, Dr. Luke, an expert in health planning and design and operation of mental health programs, projected a need for 47 adult beds with an 85 percent occupancy rate, or 50 beds with an 80 percent occupancy rate. Increased utilization of an expanded intensive treatment unit will also have a secondary impact of increased utilization of the rest of the Harbour Shores facility. Often, patients who are admitted to the intensive treatment unit will progress to a point where they qualify as higher functioning patients appropriate for transfer to the open unit. Establishment of a 12-bed intensive treatment unit that will be highly utilized should also increase utilization of the other 36 adult beds. While it is physically possible for Harbour Shores to put the 12-bed intensive treatment unit in place without adding any new beds, that would not be feasible because it would reduce the number of beds in the rest of the adult unit. With the reasonable expectation that Harbour Shores would achieve increased utilization of its whole expanded facility with approval of this project, and reasonably utilize 48 adult beds, it would be most efficient for Harbour Shores to add beds while it is renovating the facility anyway for the intensive treatment unit so as to avoid piecemeal, disruptive construction projects. Approval of the expansion project will allow Harbour Shores to provide a higher level of quality care through better segregation of the different patient groups and will also allow for accommodation of the reasonably expected utilization of intensive treatment and general adult psychiatric services. Harbour Shores has demonstrated that there is a need for its expansion project because of its unique position in subdistrict 1 as a Baker Act patient provider, the lack of alternatives for those patients, and the tendency of that patient group to need intensive treatment. Patients in the Harbour Shores service area will experience serious problems obtaining inpatient care of the type proposed by Harbour Shores in the absence of the proposed project. Subdistrict 2, Palm Beach County, has been demonstrated to be a geographically distant, separate market for short-term psychiatric services and is not an appropriate alternative for patients in subdistrict 1 needing short-term, especially intensive, psychiatric services, in light of the state health plan's goal of community-based mental health services. In addition to the special circumstance of need demonstrated at Harbour Shores, need for the additional beds is supported by the general need methodologies applied by HRS in its bed need rule for short-term inpatient psychiatric beds, Rule 10-5.011(1)(o), Florida Administrative Code, and by the local health council for HRS District 9 in its local health plan. The HRS rule methodology calculates the need for short-term psychiatric beds in an HRS district by applying a formula of .35 beds per 1,000 population projected five years into the future. Since the applications were filed in April, 1986, in its preliminary review HRS looked to the most recent population projections issued in January, 1986, for five years into the future, January, 1991. The January, 1986, District 9 population projection for January, 1991, was 1,235,361, and .35/1,000 yielded a gross need of 432 beds. Licensed and approved short-term psychiatric beds at the time of application submittal according to HRS totaled 404 beds, yielding a net bed need for the district of 28 beds. Some relevant facts external to the certificate of need applications at issue in this proceeding have changed since the applications were submitted and should be taken into account. One such fact is the more recent population projection issued for the January, 1991, planning horizon, released by the state in January, 1988. The revised District 9 population projection is 1,274,865, increasing the district bed need by 14. Another external change involves an HRS settlement with an existing provider in subdistrict 2, JFK Hospital. This settlement recognized the historic use of beds at JFK in a manner different from their licensed designation; rather than 36 short-term psychiatric beds as licensed, JFK had for many years been utilizing 22 of those beds as substance abuse beds, a different HRS bed category, and only 14 beds as short-term psychiatric beds. The HRS final order agreeing to change JFK's license to align it with JFK's actual usage was issued in March, 1988. It is, however, appropriate to correct the HRS inventory in this case to recognize the actual use of beds since by 1984, well before the applications at issue in this case were filed, HRS knew that JFK was using 22 of its 36 short-term psychiatric beds for substance abuse treatment and that those 22 beds should not be carried in the short-term psychiatric bed inventory. Additional adjustments to correct the inventory are appropriate. The Savannas Hospital's certificate of need generally indicates 70 short-term psychiatric beds; its license shows 50 short-term psychiatric beds and 20 substance abuse beds. The HRS inventory reflects the licensed bed breakdown. However, the Savannas has been reporting to the local health council that it has actually been operating only 40 short-term psychiatric beds and 30 substance abuse beds. Therefore, 10 additional beds should be subtracted from the short-term psychiatric bed inventory. There have also been questions about another District 9 facility's bed use. The average length of stay for 26 of Lake Hospital's short-term psychiatric beds is reported by Lake Hospital to be between 250 and 300 days, by definition not short-term beds. HRS admits that its inventory of beds for District 9 is not as reliable as one would hope (or expect). By making the first two adjustments (the original HRS calculation plus the JFK correction plus use of the updated population projections) to the HRS calculations, the total District 9 bed need is 64. By making all of the foregoing adjustments (the original HRS calculation plus the JFK correction plus use of the updated population projections plus the Savannas correction plus the Lake Hospital correction) to the HRS calculations, the total District 9 bed need is 100. There is no statute, and HRS has no rule or policy regulating how beds should be allocated between subdistricts. The 1985 local health plan, as updated in 1986, recommended that the district bed need be allocated between the two subdistricts in proportion to their population, i.e., .35 beds per 1,000 population projected for each subdistrict. After these applications were filed and deemed complete, the local health council approved its 1987 local health plan, in July, 1987. This new plan changed the recommended subdistrict allocation from the population-based method to a new utilization-based method. The utilization method seeks to equalize bed use in the two subdistricts in the future by applying historic utilization of existing beds to future population projections and assumes that the use pattern in each subdistrict will remain the same. In 1987, there were no more than two short-term inpatient psychiatric providers at any one time in subdistrict 1. The IRCMHC had been operating 15 inpatient psychiatric beds at capacity for some time, showing a 106.83 occupancy rate for 1986; Harbour Shores was in its second year of operation; and the Savannas Hospital first opened in March, 1987, when it began operating the 15 beds that were transferred to it from the IRCMHC and then phased in the rest of its seventy beds during the year. Essentially all of the short-term psychiatric beds in subdistrict 1, then, were in a start-up phase, utilized less than they would naturally be after a normal period of operation. Given the start-up nature of the subdistrict 1 facilities, and the corresponding 40 percent difference in use rate between subdistricts 1 and 2, it is reasonable to infer that the 1987 use rate for subdistrict 1 is artificially low, reflecting the historic forced outmigration of subdistrict 1 patients due to lack of nearby providers. The only other theory for the dramatic difference in use rates in the two subdistricts, offered by St. Mary's need witness--that subdistrict 2's population is more elderly--is rejected. No evidence was presented to substantiate that a more elderly population has a higher use rate of psychiatric services. The subdistrict allocation method in the 1987 health plan should not be applied in this case based on sound health planning principles of not changing the criteria in the middle of the application process. Further, although the new methodology might in theory be a better measure of local needs by addressing actual use patterns, in this particular case, for the data base year of 1987, the methodology is inappropriate and would perpetuate disproportionate allocation between the subdistricts. Although it is HRS's position that the 1985 local health plan (as updated in 1986) is the version that should be applied in this case, the 1985 plan should not be applied either. The plan itself states that its allocation methodology is weak at best and must be revised. Further, the Executive Director, testifying on behalf of the District 9 Health Council, stated that the 1985 allocation methodology should not be used in this case. Accordingly, no subdistrict allocation is appropriate in this case. At final hearing, Harbour Shores presented updated financial projections--pro forma statement of revenue and expenses, utilization projections, payor mix, charges and manpower salary requirements--to account for the passage of time from initial application submission and to address only the 12-bed portion of the original application for which approval is sought. The financial projections constitute an identifiable portion of the original projections, appropriately updated to take into account only factors external to the application. The financial projections provide a reasonable basis upon which to assess the financial feasibility of the proposed expansion project, and Harbour Shores has adequately demonstrated that the 12-bed expansion proposal would be financially feasible. Additionally, the parties have stipulated that Harbour Shores has the resources to fund the project and its operation if it is approved. The project cost, as updated with revised construction cost estimates, is $1,079,165. Projected utilization of the 12-bed unit is reasonable and conservative in light of the reasonable expectation of Baker Act patients who will use the intensive treatment unit. With the 12-bed expansion, Harbour Shores should easily achieve and exceed 70 percent utilization by the second year of operating a 72-bed facility, and 80 percent utilization by the third year. A reasonable projection from existing adult use and expected Baker Act utilization would be an adult average daily census of 39.8; an 80 percent facility-wide utilization would result with a minor increase in adolescent average daily census from 14.8 in 1987 to 17.8, or an adult increase in utilization. The projected charges for the intensive treatment unit, while higher than charges for general psychiatric units, are reasonable in light of the higher level of service provided in the unit, including more staff. The reasonableness of the charge is confirmed by the fact that the projected charge is the same as the Harbour Shores current charge that it is receiving for its intensive care services, i.e., $680. The projected patient mix by payor class is reasonable and reflective of the facility's actual experience. Harbour Shores includes a projection of 15 percent Medicaid patient days and 2 percent indigent days. The indigent care projection is reflective of true charity care, meaning those patients who present themselves for treatment with no means of pay. Harbour Shores has historically proven its commitment to providing care to medically indigent patients. Harbour Shores reasonably projects that it will serve a substantial percentage of those patients in its intensive treatment unit. Projected manpower for the 12-bed unit will well-serve the needs of the intensive treatment patients, and Harbour Shores should have no difficulty recruiting and securing the projected needed staff at the indicated salary levels. The projected salaries are reasonable and consistent with Harbour Shores' experience. The pro forma statement of revenues and expenses, taking into account the projected utilization, payor class breakdown and projected charges on the revenue side, and manpower salary requirements, depreciation and other expenses attributable to the 12-bed expansion, is a reasonable projection based on the facility's actual experience and future expectations; is a reasonable summary of the expected direct financial impact of the 12-bed expansion, and shows that the expansion project will be financially feasible. Additional financial benefits may accrue as a result of the secondary increase of utilization of the existing beds. The proposed 12-bed expansion project will include some new construction to create an expanded facility that will be appropriate from an architectural standpoint for the treatment of psychiatric patients, including intensive treatment patients. The construction plan is an identifiable portion of the plan presented in the original application. The only changes to the original plan are the deletion of the new geriatric wing and a change from new construction to renovation for the new patient therapy wing constructed in 1987 pursuant to a CON exemption. The construction changes necessary to accommodate the 12-bed intensive treatment unit include renovation of the central core of the facility where the classrooms are currently located for the addition of a nurse's station, creation of an entrance directly onto the unit from the central patient control corridor, creation of a charting and medicine work area directly on the unit, and installation of a separate group therapy room and a seclusion room dedicated to the intensive treatment patients. The project will also include construction of a new classroom building, required by the displacement of the existing classroom space. Construction costs for the 12-bed expansion project have been updated to reflect expected 1989 costs. Harbour Shores reasonably projects those costs to be $628,466. Expending these costs will enable Harbour Shores to complete its project in a manner that will exceed minimum licensure standards in Chapter 10D-28, Florida Administrative Code, and will fall in the upper quadrant of construction quality typical in the industry. Rule 10-5.08, Florida Administrative Code, as it existed when the letters of intent and applications were due for the batching cycle at issue in this case, established an application filing deadline of April 15, 1986, and an initial letter of intent deadline of 30 days before the application deadline, or March 16, 1986. However, paragraph (e) provided that where the ... initial letter of intent for a specific type of project has been filed with the department less than 38 days prior to the appropriate application filing due date ... a grace period shall be established to provide an opportunity for a competing applicant to file a letter of intent. The grace period, where applicable, allows letters of intent to be filed up to 16 days prior to the application due date. In this case, if a grace period were applicable the deadline for letters of intent would be March 31, 1986. Harbour Shores filed its letter of intent on March 28, 1986, and St. Mary's filed its letter of intent on March 27, 1986. Bethesda has raised the issue of whether Harbour Shores' and St. Mary's letters of intent were timely filed. Only one letter of intent related to an application that was included by HRS in the group of applications considered in the State Agency Action Report was filed with HRS 38 days or more before the application due date--the letter of intent filed by Martin Memorial Hospital. That letter of intent states that it is for 22 "short-term psychiatric/substance abuse" beds. There is no such combined category of beds. According to the State Agency Action Report, Martin Memorial's application was in fact for 22 substance abuse beds. As such, it was not a competing applicant with Harbour Shores or St. Mary's or Bethesda, and all other letters of intent were filed less than 38 days before the application due date. Accordingly, Harbour Shores' and St. Mary's letters of intent were timely filed. Bethesda filed its application with HRS on April 15, 1986. Bethesda filed its response to the HRS letter of omission on June 30, 1986, and HRS deemed Bethesda's application complete effective June 30, 1986. By letter dated July 18, 1986, received by HRS prior to the August 6, 1986, public hearing, Bethesda submitted additional information reflecting its intent to utilize and renovate existing space in its hospital instead of utilizing construction of a new wing for its psychiatric unit, as originally proposed. These three submissions constitute Bethesda's application reviewed by HRS in the State Agency Action Report. Bethesda's certificate of need application is for a 20-bed adult short-term inpatient psychiatric unit at Bethesda Memorial Hospital. Bethesda proposes to convert 20 existing licensed medical/surgical beds to short-term inpatient psychiatric beds. The beds will be placed in existing space, and there will be no new construction of space. Bethesda is a 362-bed community medical/surgical hospital licensed as a general hospital. It is a not-for-profit hospital and has served the southern portion of Palm Beach County for almost 30 years. It is accredited by the JCAHO. Bethesda has recognized from its beginning that the entire population of its service area needed to be served without regard to financial ability to pay, and the ability to pay is not a primary concern of the hospital when a patient is first admitted. The evidence is undisputed that Bethesda is committed to and provides excellent quality of care and will continue to provide excellent quality of care in the proposed psychiatric unit. The St. Mary's application seeks to place short-term psychiatric beds on a campus in the northern half of Palm Beach County, in West Palm Beach, and Bethesda Memorial Hospital is located in southern Palm Beach County, in Boynton Beach. Bethesda is the only applicant that proposes to convert underutilized medical/surgical beds into 20 short-term psychiatric beds. This factor significantly distinguishes Bethesda's proposal from that of the other applicants because there have been unused medical/surgical beds in Palm Beach County for approximately the last two years. Bethesda's proposal would take some of those unused resources and put them to more efficient and appropriate use. Historically, Bethesda has been recognized as a cost-effective hospital, not only in Palm Beach County, but throughout the State. Bethesda's projected charge per patient day, including ancillaries, is $349. This charge is reasonable. Bethesda proposes a rate significantly lower than any other applicant, making Bethesda's proposal more cost effective and competitive for patients. Bethesda's original proposed project cost was $85,000. That project cost has been updated to $88,100. This update was required primarily because of changes in the proposed floor plan necessitated by new licensure requirements imposed by HRS in Rule 10D-28.0816 adopted January 16, 1987, after the filing of Bethesda's application. The $3,100 increase in the total project cost is not a substantial change in the application. The proposed construction cost of Bethesda for renovation of $37,100 is a reasonable estimate. The movable equipment cost is a reasonable estimate. The project development cost of $20,000 is reasonable. In terms of project cost, the Bethesda application is significantly more cost effective than the St. Mary's application. The St. Mary's proposed project cost for 30 beds is $1,457,150. That is the equivalent of $48,571.67 per bed, contrasted against Bethesda's project cost of $4,405 per bed. Bethesda's project cost is also considerably lower than that of Harbour Shores. The schematic floor plan of Bethesda's proposed unit was updated due to the HRS adoption of the licensure minimum standards, which were not in existence at the time of the original application and, therefore, the original schematic did not comply with those standards. In fact, there is no significant physical difference between the updated schematic and that contained in the original application. Indeed, the space already exists in essentially the same configuration as that proposed and was in existence at the time of the filing of Bethesda's application. The proposed unit can reasonably be expected to meet licensure requirements. The Committee on Health Facilities Construction of the American Institute of Architects has set standards for the design of psychiatric facilities. They are acceptable, reasonable standards. Those standards prescribe one seclusion room for 24 beds or major fraction thereof. Bethesda's proposed facility complies with that standard. HRS has no standard for seclusion rooms. From the perspective of a practicing psychiatrist, the existing Bethesda facility with the proposed modifications meets the requirements for a facility for use in the treatment of inpatient psychiatric patients quite well. It is likely that psychiatrists in the general area surrounding Bethesda will seek to admit patients to the unit when it is in place. In addition, it is reasonable to assume that Bethesda Memorial Hospital itself will be a referral source to its psychiatric unit. The evidence also establishes that the South County Mental Health Center, Inc., a community mental health center, will be a significant referral source of patients to Bethesda's psychiatric unit. Bethesda has sufficient funds committed to cover the cost of its proposed project. The Southeast Palm Beach County Hospital District has already committed and approved $85,000 in capital expenditure funds for Bethesda's project. Bethesda has sufficient operating funds to provide the remaining $3,100. Indeed, Bethesda has sufficient operating funds to fund the entire project out of operating funds, if necessary. The Southeast Palm Beach County Hospital District has historically not used ad valorem tax revenues to subsidize the operations of Bethesda. Funds generated by the District have been used primarily for capital expenditures for Bethesda. Bethesda does not anticipate receiving any operational revenues from the Southeast Palm Beach County Hospital District for patients that might be eligible or meet some criteria established by the District for reimbursement. The projected utilization by class of pay, or payor mix, is consistent with the payor mix at Bethesda Memorial Hospital. It is reasonable to expect that the payor mix in the proposed psychiatric unit will be reflective of the payor mix at Bethesda. It was necessary for Bethesda to update its projected payor mix because the original projection reflected the 1986 payor mix of Bethesda and, primarily as a result of the extrinsic circumstance of the prospective pricing system, there has been a dramatic change in payor mix at Bethesda. Bethesda's projections include a category entitled "Baker Act/Medicaid." This category has combined Medicaid patients and those patients who would otherwise qualify as Baker Act patients who are indigent based upon their ability to pay. In the 7.7 percent for the "Baker Act/Medicaid" category, there is included 1.2 percent for indigent patients without any source of funds. It is reasonable to project that the Bethesda psychiatric unit will operate at 70 percent occupancy for the first year and 80 percent occupancy for the second year and beyond. The manpower requirements projected by Bethesda are sufficient to properly staff the proposed psychiatric unit. Bethesda has projected reasonable annual salaries. It is very likely that Bethesda will be able to recruit necessary manpower to staff its proposed facility. It was necessary for Bethesda to update its manpower requirements from these contained in its original application because of a management agreement entered into between Bethesda and Mental Health Management, Inc., on May 5, 1988. The updated manpower requirements reflect the staffing standard to be implemented by Mental Health Management, Inc., pursuant to the management agreement and the proposed treatment program. Mental Health Management, Inc., is a health care management firm that owns psychiatric and substance abuse hospitals as well as manages psychiatric and substance abuse hospital programs for client hospitals. It is a reputable and experienced management firm. No significant work, if any, was done on behalf of Bethesda by Mental Health Management, Inc., with regard to this project prior to the date of the management agreement. Bethesda's project completion forecast is reasonable. Bethesda is financially a healthy, viable institution. It is reasonable for Bethesda to project gross patient revenues in its first year of $1,783,390 and in its second year of $2,038,160. Further, it is reasonable after considering deductions from revenue for Bethesda to project net revenue in its first year of operation of $1,392,186 and in its second year of operation of $1,591,069. Bethesda has reasonably projected that its total expenses in the first year of operation will be $1,286,090 and in the second year of operation will be $1,379,362. The net result is that in the first year of operation there will be projected incremental revenue over expenses of $106,096 and in the second year of operation, incremental revenue over expenses of $211,707. In both the short term and long term, the psychiatric unit proposed by Bethesda is financially feasible. South County Mental Health Center, Inc., a community mental health center, has had a successful working relationship with Bethesda since approximately 1974. It has been a positive relationship and one which should continue with the inception of a psychiatric unit at Bethesda. Indeed, the only problem that has existed between South County Mental Health Center, Inc., and Bethesda is the lack of a psychiatric unit at Bethesda. South County Mental Health Center, Inc., presently has many patients that are not being referred for psychiatric care because there is no facility that will take them. Bethesda would, at least in part, remedy that problem. South County Mental Health Center, Inc., would primarily utilize Bethesda instead of St. Mary's because St. Mary's is in the northern part of Palm Beach County and the Center is in the southern part as is Bethesda, although it would also utilize St. Mary's. There is presently no written agreement between Bethesda and South County Mental Health Center, Inc. However, this would not be a hindrance to a relationship between Bethesda and the Center because the Center presently has no written contracts with any providers and does not anticipate any working relationship being contingent on a written contract. The service area of Bethesda Memorial Hospital includes from Southern Boulevard in Palm Beach County on the north to the Broward County line on the south, the Atlantic Ocean on the east and State Road 7 on the west. Bethesda's proposed project is consistent with the 1985, 1986 and the 1987 local District 9 health plans. The HRS rules governing amendment of applications in effect at the time the applications in this cause were filed allowed the submission of additional information without copying other applicants. HRS accepted Bethesda's July 18, 1986, application amendment letter and reviewed it as part of Bethesda's original application in its initial decision making set forth in the State Agency Action Report. HRS has never required applicants to submit copies of their applications or any supplemental or amendatory information to other applicants after the completion date but prior to the public hearing on those applications. No applicant was prejudiced by the information submitted by Bethesda to HRS in July of 1986. Indeed, the information was published at the public hearing held by HRS on August 6, 1986. All applicants knew or should have known at least by August 6 that Bethesda had changed its application to reflect use of existing space for its psychiatric unit instead of use of new construction. Yet, no applicant took any action in response to this information, even though a decision was not rendered by HRS in review of the applications until September 23, 1986, and any applicant could have changed its application up to five days prior to September 23, 1986. The changes submitted by Bethesda did not change the scope of its application. The amendment did not change the type of beds sought, the number of beds sought, the service area for those beds, the conversion of unused medical/surgical beds to psychiatric beds, or any other matter of substance. Rather, with everything else remaining essentially constant, Bethesda merely stated its intent to place the proposed unit in existing underutilized space at a cost of $85,000 instead of constructing new space at a cost of $1,391,165. Such a change is not of such a substantial nature as to improperly prejudice other applicants. There is a lack of availability in District 9 of other inpatient psychiatric services such as crisis stabilization units, short-term residential treatment programs and other inpatient beds whether licensed as a hospital facility or not. Bethesda will be linked with South County Mental Health Center, Inc., as well as practicing psychiatrists, for the provision of outpatient services. For fiscal year 1986, Bethesda gave $2,247,047 in charity care. That was 4.2 percent of its gross patient revenue for the year. In 1987, Bethesda increased its charity care to $3,615,324 which was 5.2 percent of its gross patient revenue. In fiscal 1986, St. Mary's provided $3,211,021 in charity which was 3.7 percent of its gross patient revenue. In 1987, St. Mary's provided $3,404,820 in charity care which was 3.8 percent of its gross patient revenue. As a function of percentage of gross patient revenue, Bethesda for fiscal years 1986 and 1987, provided more charity care than St. Mary' s. The average net operating revenue per adjusted admission for fiscal years 1986 and 1987, for St. Mary's was $3,120. The average net revenue per adjusted admission for the same time period for Bethesda was $3,089.50. Thus, it appears that for the years 1986 and 1987, St. Mary's effective charges for patient operations were slightly higher than Bethesda's. St. Mary's Hospital, Inc., is a 358-bed nonprofit acute care hospital located in West Palm Beach, Florida. The hospital is a wholly-owned subsidiary of St. Mary's Medical Center, Inc., which is owned by the Franciscan Sisters of Allegheny. The Franciscan mission is to provide quality health services to everyone, with a special emphasis on serving the poor and the disadvantaged. St. Mary's has been providing acute care to the medically indigent and traditionally underserved in Palm Beach County since 1938. St. Mary's contracts with the Palm Beach County Health Department to provide Palm Beach County with acute care services for the medically indigent, from prenatal to adults. Historically, St. Mary's has been the most heavily utilized hospital in the West Palm Beach area. St. Mary's has the largest market share of any hospital and serves Medicaid, uncompensated, and partially compensated patients in the area. St. Mary's has not, however, certified or committed to the provision of any specific percentage of care for Medicaid or indigent patients in this application. St. Mary's admits and treats an increasing number of AIDS patients. Because of the need to isolate AIDS patients and because of the number of indigent patients that St. Mary's treats, St. Mary's often does not have beds available for private pay patients. During the peak season, St. Mary's is unable to admit some private pay patients and must physically turn them away. Because of St. Mary's reduced ability to admit private pay patients, St. Nary's does not have a broad-based revenue source with which to cross-subsidize the cost of providing care to indigent patients. The 45th Street Mental Health Center is a not-for-profit corporation located in West Palm Beach which provides a full range of adult and older adult psychiatric services, serving primarily the indigent population. The 45th Street Center is a designated Baker Act receiving facility and, as such, it provides services without regard to the ability to pay. St. Mary's has a long-standing working relationship with the 45th Street Center and is a contracting service to the 45th Street Center. St. Mary's staff evaluates patients at both the 45th Street Center and at the St. Mary's emergency room. St. Mary's and the 45th Street Center provide referrals to each other and transfer patients between the two facilities. From 50 to 75 patients are referred from the 45th Street Mental Health Center each month to St. Mary's for medical clearance. An organized system of follow-up care exists for patients who are seen at both St. Mary's and the 45th Street Center. System protocol agreements exist between the two facilities. These agreements define the information that will be exchanged at a given clinical juncture and set forth procedures to ensure that all necessary medical and psychiatric follow-up care will take place. The demand for indigent care has become so large in the last several years that indigent patients typically occupy all of the available bed capacity at the 45th Street Center. Because it is usually fully occupied, the Center cannot always be responsive to a request from St. Mary's to accommodate psychiatric patients. In March, 1988, the 45th Street Center turned away 51 people who were in need of psychiatric treatment but for whom there were no available beds. St. Mary's filed its application for 30 short-term psychiatric beds in April, 1986. St. Mary's application was submitted by St. Mary's Hospital, Inc. The cover page of the application and the HRS CON remittance form clearly indicate that the applicant is St. Mary's Hospital, Inc. The letter from HRS to St. Mary's requesting responses to certain omissions from the application is addressed to St. Mary's Hospital, Inc., and was completed and returned by St. Mary's Hospital, Inc. The Board of Trustees of St. Mary's Hospital, Inc., adopted a Resolution authorizing the filing of the CON application by St. Mary's Hospital, Inc. The Resolution is signed by the Assistant Secretary of St. Mary's Hospital, Inc. The certification page at the end of St. Mary's application is signed by John Fidler, President of St. Mary's Hospital, Inc. Prior to submitting its CON application, St. Mary's considered converting some of its existing medical/surgical beds to short-term psychiatric beds, rather than engage in new construction. The cost of renovations, together with the compromises which would exist in the recreational and programmatic areas needed for psychiatric treatment, resulted in St. Mary's decision that it would be more appropriate to build a separate psychiatric pavilion than to convert existing medical/surgical beds to psychiatric beds. The psychiatric pavilion will not be a free-standing facility. The full services of St. Mary's acute care hospital will be available to the patients in the psychiatric unit. A continuum of care will be provided to the psychiatric patients through the use of St. Mary's existing psychiatrists, social workers, recreational therapists, psychologists, and other related therapy and support personnel. Clinical support personnel will be available to address the psycho-social problems of patients in the psychiatric unit. The psychiatric unit would be a distinct unit for reimbursement purposes, but would be licensed under St. Mary's hospital license. St. Mary's proposed psychiatric unit will use the existing food services at St. Mary's and will not require the construction of a new kitchen. The existing kitchen at St. Mary's is immediately adjacent to the planned psychiatric unit. The existing kitchen and food preparation area is currently operating at only 40 to 60 percent of capacity and is adequate for the proposed psychiatric unit. St. Mary's offers a full range of dietary products and specialized menus. The existing laundry facility at St. Mary's has sufficient capacity to support the planned psychiatric unit. St. Mary's submitted updated information at the Final Hearing relating to its original application for 30 short-term psychiatric beds. Several factors contributed to St. Mary's decision to update its original application. When the original application was prepared in April, 1986, St. Mary's had a CON application pending before HRS for a 20-bed rehabilitation unit. St. Mary's received approval from HRS for a 20-bed rehabilitation unit after the filing of this application. A portion of the existing emergency room space at St. Mary's intended for use by the psychiatric pavilion will be used as part of the 20-bed rehabilitation unit. Another factor was the promulgation of the new HRS minimum standards rule, which requires the addition of several service areas not required when St. Mary's submitted its original application. The new HRS rule requires a separate head nurse's office, separate charting areas, and more square footage in the activity areas. In addition, the new rule requires a second occupational therapy area, natural light in the seclusion rooms, and requires public toilets to be handicapped accessible. Because of the nature of St. Mary's original schematic, it was impossible to add square footage to the design, and St. Mary's therefore developed a new schematic to incorporate the various changes required by the new HRS rule and by the new rehabilitation unit. The JCAHO standards for hospital design specifically address the issue of having non-institutional architectural design in psychiatric units. The design of a psychiatric facility has a very definite affect on the patterns of behavior of psychiatric patients. The updated architectural schematic contained in St. Mary's application is highly conducive and therapeutically appropriate to a psychiatric program. The St. Mary's schematic is non- institutional in design and has a number of open spaces and clear vistas, with immediate access to outdoor recreational areas. St. Mary's proposal is designed to provide security surveillance of the exits while at the same time providing privacy for personal interaction between patients and staff. The more vistas and the more access to sunlight and open spaces a facility has, the less likely it is that systemic institutional responses and behavior will be produced. The enclosed open courtyard contemplated in the St. Mary's design has the advantage of providing open space while also providing a high level of security. The proposal by St. Mary's would be in substantial compliance with the JCAHO standards of providing a therapeutic environment. The proposed construction costs for St. Mary's psychiatric unit will be $85 per square foot. These costs are reasonable for the type of construction and design proposed by St. Mary' s. The staffing proposed by St. Mary's is sufficient to operate a 30-bed short-term psychiatric unit and is sufficient to address the clinical needs of the projected patient population. St. Mary's proposed admissions policy, clinical elements, and psychiatric program are appropriate for the treatment of psychiatric patients. St. Mary's proposed gero-psychiatric program is a logical extension of the services currently being provided by the 45th Street Mental Health Center. The Center has a geriatric residential treatment service, funded by the Legislature and HRS, which serves a relatively high percentage of gero- psychiatric patients. Many of the patients at the 45th Street Center have both psychiatric conditions and medical complications, and the St. Mary's psychiatric unit would be available for patients discharged from the 45th Street Center. The South County Mental Health Center, located 30 minutes from St. Mary's, will be willing to use St. Mary's proposed psychiatric unit. The total cost of St. Mary's proposal is $1,457,150. St. Mary's has a Foundation responsible for raising money for the various St. Mary's corporations. The present donated Foundation Fund balance as of April, 1988, is $12,486,566. Of the Fund balance, approximately $1.9 million is unrestricted and is available to construct the proposed 30-bed short-term psychiatric unit. St. Mary's proposes a per diem patient charge of $368 per day for the first year of operation and $398 per day for the second year of operation. This is an increase from the patient charges contained in St. Mary's original application, but the increase is attributable to the fact that salary levels at both St. Mary's and in the hospital industry as a whole have increased over the last several years. St. Mary's projects ancillary charges of $70.72 per day for the first year of operation and $76.51 per day for the second year of operation. The proposed room rates for St. Mary's are reasonable based on a market survey of room rates in the Palm Beach County area. The St. Mary's proposal is financially feasible on a long-term basis because there are adequate revenues to cover operating expenses. St. Mary's will assure high quality of care at its proposed 30-bed psychiatric unit through the existing medical information system at St. Mary's. The medical information system coordinates quality assurance, medical records, utilization, and medical staff office functions. With the system, all patient records at St. Mary's are screened on a daily basis against set indicators of care. If certain criteria are met, that patient record is automatically referred to an Evaluation Committee. There are four separate Evaluation Committees at St. Mary's, each composed of physicians who conduct peer review. The recommendation of the Evaluation Committee is forwarded to the Medical Executive Committee, which has the authority to act based upon the recommendation of the Evaluation Committee. The patient record review process at St. Mary's is part of a quality assurance umbrella, which includes infection control, utilization review, and discharge planning. The purpose of utilization review is to determine whether a given patient should be receiving the level of care being provided or if a lesser level of care could be provided on a more cost-effective basis. The quality assurance utilization review at St. Mary's is approved by the JCAHO.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED that a Final Order be entered: Granting Harbour Shores' application for a certificate of need for 12 short-term psychiatric beds; Granting Bethesda's application for a certificate of need for 20 short-term psychiatric beds; and Granting St. Mary's application for a certificate of need for 30 short-term psychiatric beds. DONE and RECOMMENDED this 7th day of October, 1988, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of October, 1988. APPENDIX TO RECOMMENDED ORDER CASE NOS. 86-4354, 86-4356, 86-4358 Harbour Shores' proposed findings of fact numbered 1-42, and 44-55 have been adopted either verbatim or in substance in this Recommended Order. Harbour Shores' proposed findings of fact numbered 43, 56, 57, and 58 have been rejected as being unnecessary for determination of the issues in this proceeding. Bethesda's proposed findings of fact numbered 1-4, 6-30, 32-47, 49, 51, 52, 64, 66, 69-71, 73-75, 78, and 83 have been adopted either verbatim or in substance in this Recommended Order. Bethesda's proposed findings of fact numbered 48, 67, 76, and 77 have been rejected as being unnecessary for determination of the issues in this proceeding. Bethesda's proposed findings of fact numbered 5, 54, 63, and 65 have been rejected as being contrary to the weight of the totality of credible evidence in this cause. Bethesda's proposed findings of fact numbered 31, 50, 53, 55-62, 68, 72, and 80-82 have been rejected as not constituting findings of fact but rather as constituting argument of counsel or conclusions of law. Bethesda's proposed finding of fact numbered 79 has been rejected as not being supported by the weight of the evidence in this cause. St. Mary's proposed findings of fact numbered 1-3, 5-29, 34, 36-38, and 40-53 have been adopted either verbatim or in substance in this Recommended Order. St. Mary's proposed findings of fact numbered 4, 30, 35, 39, 54, and 55 have been rejected as not being supported by the weight of the evidence in this cause. St. Mary's proposed findings of fact numbered 31-33 have been rejected as being unnecessary for determination of the issues in this proceeding. HRS' proposed findings of fact numbered 1, 2, 4, 6-9, 12-15, 20-22, 24, 32-34, 36-43, 45-48, 50-56, 59, 65, 67, 78-81, 85, 89, 99, and 101 have been adopted either verbatim or in substance in this Recommended Order. HRS' proposed findings of fact numbered 3, 17-19, 35, 57, 58, and 62- 64 have been rejected as being unnecessary for determination of the issues in this proceeding. HRS' proposed findings of fact numbered 5, 10, 11, 44, 49, 72, 74-77, 82-84, 95-97, 100, and 104 have been rejected as being subordinate to the issues in this proceeding. HRS' proposed findings of fact numbered 16, 23, 25, 28, 29, 31, 66, 69-71, 73, 90, and 103 have been rejected as being contrary to the weight of the evidence in this cause. HRS' proposed findings of fact numbered 26, 27, 30, 60, 61, and 86-88 have been rejected as not being supported by the weight of the evidence in this cause. HRS' proposed findings of fact numbered 68, and 91-93 have been rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. HRS' proposed findings of fact numbered 94, 98, and 102 have been rejected as being irrelevant to the issues under consideration herein. COPIES FURNISHED: Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Robert D. Newell, Jr., Esquire Thomas W. Stahl, Esquire 102 South Monroe Street Tallahassee, Florida 32301 Lesley Mendelson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Chris H. Bentley, Esquire 2544 Blairstone Pines Drive Tallahassee, Florida 32301 John Radey, Esquire Elizabeth W. McArthur, Esquire 101 North Monroe Street Tallahassee, Florida 32301 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700

Florida Laws (1) 120.57
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BOCA RATON ARTIFICIAL KIDNEY CENTER, INC., AND DELRAY ARTIFICIAL KIDNEY CENTER vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES AND HOSPITAL CARE COST CONTAINMENT BOARD, 86-004459 (1986)
Division of Administrative Hearings, Florida Number: 86-004459 Latest Update: Apr. 02, 1987

Findings Of Fact New findings of fact have only been made in accord with the limited mandate/remand jurisdiction of the appellate court. Otherwise, findings of fact contained in the recommended order of Hearing Officer R. T. Carpenter entered September 18, 1985, have been adopted and incorporated by reference. To the extent the adopted original findings impact on the new findings, they have been adopted, following review of the record and the parties' submissions, for content. Any language from the original recommended order which has not been adopted is rejected in accord with the court's limited remand. Paragraph 1 (including footnote 1) of the original recommended order entered in this cause, copy attached as Exhibit "A", is adopted and incorporated by reference. The "service area" at issue was disputed by the parties. HRS District 9 encompasses Palm Beach, Indian River, Okeechobee, Martin and St. Lucie counties. Paragraph 3 of the original recommended order entered in this cause, copy attached as Exhibit "A", is adopted and incorporated by reference. Only the second and third sentences of paragraph 4 of the original recommended order entered in this cause, copy attached as Exhibit "A", are adopted and incorporated by reference. Paragraph 5 including (footnote 3) of the original recommended order entered in this cause, copy attached as Exhibit "A", is adopted and incorporated by reference. See also new finding of fact 8 infra. The Network 19 representative, who was similarly qualified, calculated a need for five additional stations but his methodology, calculations, and ultimate result is rejected for reasons clear from the remand opinion dealing with application by Mr. Moutsatos of the wrong population data and for use of an incorrect "service area" as set forth in new finding of fact 7 infra. As noted, the geographic location wherein the applicant, West Boca, seeks to locate, is Boca Raton, Palm Beach County, Florida, a county within HRS District 9. Rule 10-5.11(18), Florida Administrative Code, does not define "service area." District 9 has not been subdivided by either the local health council or HRS. The original application filed by West Boca indicated the proposed service area would be Palm Beach County. At the administrative hearing, West Boca, over Boca Raton AKC's and Delray AKC's objections, was permitted to introduce an amended application which designated a sub-area of Palm Beach County as its "service area", and the original recommended order entered herein recognized such an abbreviated area. Contrariwise, the HRS final order ruled that Palm Beach County was the appropriate service area to be used in applying the need methodology contained in the rule. Because this aspect of the final order was affirmed by the First District Court of Appeal, it becomes "law of the case" and Palm Beach County must be used as the service area for applying the methodology to this applicant. State v. Stebile, 443 So.2d 398 (Fla. 4th DCA 1984), Marine Midland Central v. Cote, 384 So.2d 658, (Fla. 5th DCA 1980). However, because the parties' submissions have insinuated this element of "service area" into the remand consideration of this cause, it may be noted that the record is clear that at all times relevant (including but not limited to the date West Boca's application was deemed complete, the date the application was preliminarily reviewed by HRS, and the date of hearing) HRS used Palm Beach County as the appropriate "service area" as contemplated by Rule 10- 5.11(18). West Boca has failed to demonstrate within the evidence received at the prior hearing that a smaller area should be defined for purposes of these proceedings. This determination is made notwithstanding evidence of desirable driving times for end stage renal dialysis (ESRD) patients and superfluous language employed by HRS' expert witness, Ms. Dudek, to the effect that although HRS policy and procedure always utilized Palm Beach County, a sub-area need determination is not an inappropriate measure of need for health planning purposes. These latter elements have been considered but are not persuasive that a smaller sub-area is appropriate in the face of sound health planning reasons for not using smaller than county sub-areas. The present submissions of West Boca on remand also fail to demonstrate any compelling reason to depart from normal HRS policy and procedure. In evaluating an application for a CON for a proposed chronic renal dialysis facility, HRS utilizes the methodology contained in Rule 10-5.11(18), Florida Administrative Code. The First District Court of Appeal has ruled that the need for the West Boca facility must be determined utilizing the "1983-84 population data as received into evidence at the prior hearing" and determining need for the proposed dialysis center one year from the date that the application is deemed complete by HRS. West Boca's application was deemed complete in February of 1983. The 1984 population of the service area (Palm Beach County) was 689,325. The 1984 new patient acquisition rate was 197.29 per million. The 1984 service area mortality rate was 23.8 percent. This data was gathered by the District 9 Health Council and the HRS Office of Community Medical Facilities from ESRD providers for the calendar year 1984. In calculating the need under the ESRD methodology the first variable is "current ESRD patients by census for service area." At the administrative hearing in this case, Elizabeth Dudek, Community Medical Facilities Consultant for HRS concluded that 4 stations were needed. (See original Finding of Fact 5, adopted in new Finding of Fact 5 supra.) However, Ms. Dudek also testified that this "patient census" number was 260. Ms. Dudek obtained this "260" figure from the Florida ESRD Network 19 First Quarter Report 1985. She totaled the in-patient census figures for the Palm Beach County facilities to obtain this figure. However, since that figure represents only in-center patients, from which the second variable ("ESRD patients on home dialysis") is to be subtracted, the patient census number of 260 as given by Ms. Dudek and as contained in HRS exhibit 1 is in error. The correct number for the first variable in the ESRD methodology can only be determined by adding in-center patients and home dialysis patients (260 + 24 284). HRS is required to correct any factual errors within its knowledge. Balsam v. HRS, 486 So.2d 1341 (Fla. 1st DCA 1986). Since the patient census in HRS exhibit 1 is in error, the correct figure should be substituted. Once this is done, the correct procedure for calculating the need for a proposed ESRD facility in Palm Beach County, which application was deemed complete in 1983, is as follows: Current ESRD patients by census for service area (Palm Beach County) 284 Less ESRD patients on home dialysis 24 Plus new ESRD patients per 1 million population for one year [computed using 1984 new patient acquisition rate multiplied by 1984 projected population] 136 Less projected number of ESRD patients to receive home dialysis training 12 Less number of ESRD patients receiving transplant operations for one year 7 Less number of unsuccessful transplants for one year 0 Less ESRD patient mortality for one year [In calculating need under the ESRD methodology, if the "patient census" number is changed, then the variable "ESRD patient mortality for one year" will also change. Therefore, the patient mortality is determined by the following procedure: mortality rate based on experience for service area applied to the subtotal of previous calculations (284-24+136-12-7-0--377; 377 x 23.8 percent 90). See Rule 10-5.11(18)(b)1. Florida Administrative Code and HRS exhibit 1.] 90 Plus 10 percent of current and projected ESRD patients on home dialysis 4 Equals number of patients requiring chronic dialysis services for one year in the service area 291 The Rule also provides that 80 percent of the capacity of four patients per station per week is to be utilized, yielding a factor of 3.2. This is divided into the number of patients requiring chronic dialysis services for one year in the service area (291). The dividend, 91, is the number of stations needed in the service area, less the 84 existing stations, for a net need of seven stations in Palm Beach County in 1984. (Note that where permitted all figures have been "rounded" to the nearest whole number). Petitioners identified some relatively minor errors in input data and calculations. These errors would not, however, significantly change the so- called "hard numbers" stated above in new Finding of Fact 8. The more significant error of Ms. Dudek described therein is purely one of arithmetic and its required correction, in no way does violence to that witness' correct application of the rule methodology. Both the Applicant and Petitioners presented additional expert testimony of health care consultants. Not surprisingly, their conclusions tended to reduce the need on one hand (Petitioners) and increase it on the other (Applicant). Although their testimony is incorporated in those considerations discussed in new Finding of Fact 11 (adopting original recommended order paragraphs 11-24 inclusive), it is rejected as to modification of the data utilized and generated by the HRS witness. 11. Paragraphs 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22 (see also new findings of fact 5-8,) 23, and 24 of the previous recommended order entered in this cause, copy attached as Exhibit "A", are adopted and incorporated by reference.

Florida Laws (1) 120.57
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DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES vs. GOLDEN SHORES CONVALESCENT CENTER, INC., 80-000341 (1980)
Division of Administrative Hearings, Florida Number: 80-000341 Latest Update: Jun. 19, 1981

The Issue Did Golden Shores fail to provide adequate and appropriate nursing care for Mrs. Lindablad because maggots were found in a wound on her right hip and in the wall of her vagina between October 22, 1979 and October 24, 1979? Did Golden Shores violate the terms of either Chapter 400, Part I, Florida Statutes, or Section 10D-29, Florida Administrative Code, by refusing to allow inspection of its facility by an OLC inspection team on January 25, 1980?

Findings Of Fact The Golden Shores Convalescent Center, Inc. is a nursing home facility in Tampa, Florida. Ms. Patricia Gilbert is its Administrator. The Office of Licensure and Certification (OLC) of HRS is responsible for the investigation of complaints about the operation of nursing facilities, such as Golden Shores, which are licensed by HRS. Prior to the OLC investigation in issue the Office had received an anonymous complaint about housekeeping, urine odors, dietary preparation, and staffing at Golden Shores. The Office had also received a complaint from the Chairman of the Ombudsman Committee alleging that portions of the nurses call system were not functioning. As the result of these complaints, Mr. Joel Montgomery, an HRS hospital consultant, Mrs. Dorothy Brown, a public health nurse, and Mrs. Emily Echols, a nutrition consultant, arrived unannounced at Golden Shores on January 25, 1980, at 9:00 A.M. to conduct a complaint survey of the facility. Two days prior to this visit the Tampa Tribune newspaper published a story, described by its author as "sensational", on the occurrence of maggots in a Golden Shores patient. The Golden Shores staff was very agitated about the bad publicity in the article. They felt betrayed by HRS whom they assumed to be the source of the story.3/ It was under these circumstances that the Administrator of Golden Shores, Mrs. Gilbert, refused to allow the inspection team to tour the facility. When the OLC team arrived, Mrs. Gilbert placed a call to the facility's counsel and then informed her staff that the team was there for an inspection but she was seeking legal advice. After her conference with counsel she decided to refuse the team access that morning. She did not want to allow an inspection of the facility without counsel present. She was especially concerned that her staff would comment on the maggot case which she intended to later litigate with HRS.4/ While Mrs. Gilbert courteously offered to allow an inspection of the facility in the afternoon of January 25, 1980, that opportunity conflicted with the schedule of Mr. Montgomery, the inspection team leader. A later inspection was subsequently arranged between the parties. It was satisfactorily conducted on January 31, 1980. In the interim between January 25, 1980 and January 30, 1980, HRS placed a moratorium on new admissions into Golden Shores. This was lifted when Golden Shores agreed to a second inspection. During this inspection it was discovered that except for the nurses call system problem the complaints were unfounded. While the allegations of the anonymous complaint proved to be untrue, the facts alleged in the complaint were directly related to the proper care and health of Golden Shores' patients. On August 28, 1979, Mrs. Alice Lindablad was admitted to Golden Shores from Lykes Memorial Hospital in Brooksville, Florida for long term care. Mrs. Lindablad was in poor physical condition. She had been diagnosed as having arteriosclerotic heart disease, congestive heart failure, and multiple infected decubiti ulcers (bed sores). The ulcers which were present on the patient's legs, feet and hips contained necrotic (dead) tissues and oozed a green fluid. The skin around the ulcers was black. The patient also had a vascular insufficiency which caused her left foot to develop gangrene. The foot became necrotic, foul smelling, and turned black. Dr. Perez was Mrs. Lindablad's attending physician. Because of the condition of her left foot, he transferred the patient on October 5, 1979, to St. Joseph's Hospital for a surgical evaluation. She was determined to be a poor surgery risk and therefore nothing was done toward amputating her left foot. She was returned to Golden Shores and remained there until her death on October 31, 1979. During her care at Golden Shores, Dr. Perez prescribed the following treatment for the decubitus ulcers: wet to dry dressings over the ulcers, q-4 hours 5/; mechanical debridement of the wounds; and the administration of antibiotics. After her return to Golden Shores, Mrs. Lindablad slowly deteriorated. The ulcers remained infected. She became lethargic and exhibited the symptoms of possible septicemia (a local infection spreading throughout the blood stream). The most serious ulcer which was on her right hip was so deep that the bone could be seen. By October 19, 1979, her left foot was completely black. During the 3:00 to 11:00 P.M. nursing shift on October 22, 1979, a nurses aide, Ms. Lorine Rowland and Ms. Dorothy Poore, the evening charge nurse, entered Mrs. Lindablad's room to change her dressings. Because more 4x4 dressings were needed, Ms. Poore left to obtain them. At the same time, as Ms. Rowland removed the dressing on the patient's right hip, she saw maggots in the sore. Ms. Rowland put the bandage back on and told what she saw to Ms. Poore who immediately called Dr. Perez. He responded to the message left with his answering service within five to seven minutes. After Ms. Poore told him what she had seen, he said "good, we'll just cover that with a dry dressing and make sure it is well taped down". The maggots continued to be present in the patient's right hip ulcer until around 9:00 A.M. on October 24, 1979. At that time Ms. Brunjes, director of nursing services, examined the patient and found no evidence of maggots either on the patient's body or in her bed linen. Prior to Ms. Brunjes' examination maggots had been noted by Ms. Suzanne Davis, LPN, on the October 23, 1979, 11:00 P.M. to October 24, 1979, 7:00 A.M. shift in Ms. Lindablad's labia and her vagina. The maggots' presence on Ms. Lindablad was a fortuitous occurrence. They were not purposely applied by either the nurses or by Dr. Perez. But once there, Dr. Perez decided to take advantage of their ability to debride necrotic tissue without damaging live tissue. Maggots are the larva of the common house fly. The presence of maggots indicates that at sometime while she was at Golden Shores a female fly must have landed on Mrs. Lindablad and laid eggs in her right hip ulcer. Flies are attracted to necrotic tissue as a place for them to lay eggs. Because of her numerous sores and rotting left gangrenous leg, Mrs. Lindablad was very attractive to flies. Before the advent of modern antibiotics sterile maggots were used by the medical profession to debride wounds of dead tissue. While this practice is no longer common today, the medical community is still familiar with the use of maggots and their use is not necessarily poor health care. There was a calculated risk in allowing the maggots to remain in the patient here because they had not been raised in a sterile environment and they could spread unknown bacteria. It is not below community medical standards for Dr. Perez to have allowed the continued presence of maggots in Mrs. Lindablad's right hip ulcer and it is not poor health care for Golden Shores to have followed his orders to leave the maggots undisturbed. There is no evidence that near the time of the occurrence of maggots on Mrs. Lindablad Golden Shores had a prevalence of flies in the patient care area, or in any other part of the facility. An occasional fly has however been observed in the wards. No flies were ever observed in Mrs. Lindablad's room. The record here is barren of any showing that Golden Shores either took extraordinary measures to prevent the occurrence of flies or that Golden Shores was careless about insect control. Subsequent to the appearance of the maggots in Mrs. Lindablad's hip decubitus, they were noted around her vagina and in her bed linen. Maggots are attracted to the warm damp mucoid areas of the human body. Dr. Perez on being notified of the maggots initial appearance had ordered a dry dressing over the maggots to be well taped down. It is a reasonable inference that this taping was to prevent the possible migration of the maggots. Again there is no showing that the staff at Golden Shores were either extraordinarily careful about taking measures to prevent the migration of the maggots on Mrs. Lindablad or that they were careless in not preventing the maggots migration. Once the maggots were discovered on the edge of the patient's labia and her vagina, they were washed away by Ms. Davis with a sterile solution and disposed of. The linen on the patient's bed was immediately changed. It is possible that the tape which held the dry dressing on Mrs. Lindablad's right hip became loose from the many times her body had to be turned. A paper tape, rather than ordinary adhesive tape, was used to secure the patient's dressings because her delicate skin could have been harmed by ordinary tape. Mrs. Lindablad's death on October 31, 1979, was not in any way related to the occurance of maggots on her body or in her bed.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law it is, RECOMMENDED: That an administrative fine in the amount of $300.00 be imposed on Golden Shores Convalescent Center in Case No. 80-341. It is further RECOMMENDED that the complaint in Case No. 80-342 be dismissed. DONE and RECOMMENDED this 10th day of April, 1981, in Tallahassee, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of April, 1981.

Florida Laws (6) 120.57120.65400.102400.121400.19400.23
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