The Issue An amended administrative complaint, dated July 31, 1989, alleges various violations of Chapter 459, F.S., by Respondent. Counts V, VI and VII, relating to Respondent's treatment of patient, R.C., were voluntarily dismissed by Petitioner at the commencement of the hearing. The following allegations are left at issue: That Respondent violated Section 459.015(1)(u), and (y), F.S., by prescribing Percodan and Ritalin, controlled substances, to his wife, G.I., inappropriately or in excessive quantities. That in the treatment of his wife, Respondent failed to practice osteopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances, in violation of Section 459.015(1)(y), F.S. That Respondent violated Section 459.015(1)(p), F.S., by failing to keep medical records justifying the course of treatment of G.I.; and that of his mother, M.I., for whom he prescribed Demerol.
Findings Of Fact Respondent, Donald Iafornaro, D.O., is and has been at all times material to the allegations of the amended administrative complaint, a licensed physician in the State of Florida, with license number OS 0001794. Dr. Iafornaro has a limited osteopathic practice which he conducts from his home at 1802 North Lakemont, Winter Park, Florida. He has about fifty patients, and also treats his large family, including his wife, mother, eleven children and grandchildren. G.I. has been a patient of Dr. Iafornaro for approximately 25 years -- since 1973, as his wife, and prior to that, from 1964, along with the rest of her family in Cleveland, Ohio. Mrs. Iafornaro has had a demanding job caring for the Iafornaro children, her mother-in-law, the house and pets, and has recently been her husband's only staff in his practice. Between May 1985, and April 1987, her husband treated her for a variety of medical problems, including severe allergies, sleep apnea (a mechanical difficulty in breathing during deep sleep), depression, fatigue, a chronic fracture of the foot bone (a fracture which failed to heal), spinal stenosis, an unstable hip, ulcers, angina and various gynecological complaints Between May 1, 1985, and April 11, 1987, Dr. Iafornaro prescribed the following drugs, among others, to his wife: 2,720 tablets of Percodan 900 tablets of Ritalin Percodan is the product name for oxycodone hydrochloride, and Ritalin is the product name for methylphenidate hydrochloride. Both are Schedule II controlled substances and are legend drugs as defined in Section 465.003(7), F.S. With the concurrence of the parties, official recognition was taken of the Physician's Desk Reference (PDR) for the years 1984-1987. Petitioner also presented the testimony of two osteopathic physicians practicing in Dr. Iafornaro's community. The evidence from these authorities established that the prescriptions of Percodan and Ritalin for G.I. were inappropriate or in excessive quantities. Dr. Iafornaro felt that Ritalin was necessary to counteract the sedative effect of the antihistamines his wife had to take for her many allergies. He also prescribed the Ritalin for her depression. Ritalin is a mild central nervous system stimulant. It is indicated for attention deficit disorders (primarily in children) and narcolepsy. It should not be used for severe depression or for the prevention or treatment of normal fatigue. The PDR warns of drug dependence. Ritalin is also contraindicated in patients, such as G.I., who have exhibited anxiety, tension, depression and agitation. Ritalin may cause reactions such as skin rashes, a common complaint of this patient, but a problem which Dr. Iafornaro attributed to her multiple allergies. The Percodan was prescribed by Dr. Iafornaro for his wife's pain in her foot and for other pain in her low back and in her wrist. The PDR warns that Percodan may be habit forming. It contains aspirin, which can aggravate ulcers. It is indicated for relief of moderate to moderately severe pain; it is a depressant; it can cause apnea and respiratory depression in an overdose. Mrs. Iafornaro's statement that she used only about a half a tablet a day is inconsistent with the volume of the drugs prescribed for her over the relevant period. Dr. Iafornaro produced all of his medical records for G.I. for the relevant period. He claims they are incomplete because he also makes notes on odds and ends, writes on the back of a medical journal and keeps a lot of records in his head. (Iafornaro Deposition, p.15) The medical records produced by Dr. Iafornaro do not justify his course of treatment,for this patient, and particularly fail to explain the long-term volume of drugs that he was prescribing. Dr. Iafornaro claims that the probable cause panel previously reviewed his records and found them acceptable. The records were produced in response to charges that he had violated certain terms of an earlier disciplinary action. The issue was resolved with a "no probable cause" finding. That finding, in 1983, was for a different time period than the period at issue in this proceeding. Dr. Iafornaro provided records to the panel covering a limited period in 1983 when he was treating his wife for her foot fracture, a slip and fall accident and other acute conditions. The 1983 records, in contrast to those at issue here, describe the condition and his treatment. The later records provide copious listings of a variety of prescriptions, including the Percodan and Ritalin, with scant examination results, explanation of the condition being treated, or diagnoses of the complaints. Complete written medical records are an essential element of prudent osteopathic practice, particularly when, as here, the physician is treating his family and his objectivity may be questioned. Between January 5, 1987, and March 1, 1987, Dr. Iafornaro prescribed 200 50 mg Demerol tablets to his 84 year old mother, M.I. Demerol is a product name for meperidine hydrocloride, a Schedule II controlled substance, and a legend drug as defined in Section 465.003(7), F.S. The basis for the prescriptions was an episode of right upper quadrant pain felt to be of gallbladder origin. It is cheaper to purchase Demerol tablets by the 100. After M.I. took a few of the first prescription of 100, she lost the bottle and Dr. Iafornaro replaced it with another prescription. The medical records make no mention of the lost prescription, but they marginally justify the use of this drug for the limited period in issue and for the purpose intended. A previous disciplinary case involving allegations of Dr. Iafornaro's improper prescriptions and record-keeping practices was resolved with a stipulation for his one-year probation with conditions. The stipulation was approved by the Board of Osteopathic Medical Examiners in a Final Order entered on December 28, 1982. (DPR Cases #0010979, 0014467, and 0015303)
Recommendation Based on the foregoing, it is hereby, RECOMMENDED That the Department of Professional Regulation, Board of Osteopathic Medical Examiners enter a Final Order which finds Donald Iafornaro, D.O., guilty of having violated the provision of Subsection 459.015(i)(p), (u) and (y), F.S. and imposing the following penalties: Suspension of license for 90 days and until such time as he appears before the Board of Osteopathic Medical Examiners and establishes that he has taken and passed the examination conducted by the National Board of Examiners for Osteopathic Physicians and Surgeons or the Special Purpose Examination (SPEX) of the Federation of State Medical Boards, as designated by the Board of Osteopathic Medical Examiners in its final order; Upon reinstatement that his license be placed on probation for two years subject to such terms and conditions deemed appropriate by the Board, including, but not limited to, restriction of practice, direct or indirect supervision of practice or prescribing of controlled substances and required additional continuing education; That he be permanently restricted from prescribing controlled substances to family members, unless under direct supervision of another osteopathic physician; That a reprimand be imposed; That a fine of $2,000. be imposed. DONE AND RECOMMENDED this 23rd day of February, 1990, in Tallahassee, Leon County, Florida. MARY CLARK 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 23rd day of February, 1990. APPENDIX TO THE RECOMMENDED ORDER IN CASE NO. 88-5277 The following constitute specific rulings on the findings of fact proposed by the parties. Petitioner's Proposed Findings Rejected as unnecessary. Adopted in paragraph 1. 3.-5. Adopted in paragraph 5. Adopted in paragraphs 6, 8 and 10. Some blood pressure monitoring is found in the records however. Adopted in paragraph 6. Adopted as a conclusion of law and in paragraph 6. Adopted in paragraph 12. Adopted in paragraph 15. Adopted in paragraph 16. Rejected as contrary to the weight of evidence. Adopted in substance in paragraph 19. Respondent's Proposed Findings Rejected as unnecessary. Adopted in paragraph l. Adopted in part in paragraphs 7-10, otherwise rejected as unnecessary. 4.-6. Rejected as contrary to the weight of evidence. 7.&8. Adopted in paragraphs 15, 17 and 18. 9. Rejected as immaterial. COPIES FURNISHED: Bruce D. Lamb, Esquire Dept. of Professional Regulation 730 S. Sterling Street Tampa, FL 33609 Sam Murrell, Jr., Esquire P.O. Box 1749 Orlando, FL 32802 Kenneth D. Easley, General Counsel Dept. of Professional Regulation 1940 N. Monroe St., Suite 60 Tallahassee, FL 32399-0792 Rod Presnell Executive Director Osteopathic Medical Examiners Dept. of Professional Regulation 1940 N. Monroe St., Suite 60 Tallahassee, FL 32399-0792
The Issue The issue posed herein is whether or not the Respondent's Osteopathic Physician License should be suspended, revoked or otherwise disciplined based on conduct, which will he set forth herein in detail, as set forth and defined in the administrative complaint filed herein on September 30, 1980.
Findings Of Fact Respondent, during times material, has been an Osteopathic Physician who has been issued License No. 0003850. On or about April 17, 1978, Respondent, Joel Z. Spike, entered into a Consent Agreement with the Board of Osteopathic Medical Examiners, hereinafter referred to as the "Board", the terms of which provided that if the Respondent complied with certain conditions precedent and subsequent to the issuance of a license, that the Board would issue to Respondent a one-year probationary license to practice osteopathic medicine within the State of Florida. Under the terms of the Consent Agreement, Respondent's failure to satisfy any of the conditions subsequent to the issuance of the probationary license would result in an automatic suspension of such license. The Consent Agreement was entered as a final order of the Board. (Petitioner's Exhibit 1). Respondent satisfied the conditions precedent and the Board issued the Respondent a probationary license on April 27, 1978. 2/ On March 28, 1979, it is alleged that Respondent failed to satisfy one of the conditions subsequent to the Consent Agreement of April 17, 1978 by his (Respondent's) failure to make a required annual appearance before the Board to demonstrate his physical and mental condition and ability to practice osteopathic medicine with reasonable skill and certainty. It is thus alleged that pursuant to the terms of the Consent Agreement and order of April 17, 1978, Respondent's license was automatically suspended. 3/ On March 28, 1979, Respondent and the Board entered into a second Consent Agreement under the terms of which Respondent agreed to cease and desist from the practice of osteopathic medicine in this State until such time as the Respondent could make a personal appearance before the Board, such appearance being an unsatisfied condition subsequent or required by the first Consent Agreement entered by and between the parties dated April 17, 1978. Respondent signed the second Consent Agreement which was entered as a final order from the Board and became effective April 24, 1979. On July 18, 1979, August 1, 1979, September 19, 1979, September 25, 1979, July 24, 1979, October 8, 1979, November 5, 1979, October 31, 1979, and October 22, 1979, Respondent wrote prescriptions for Percodan tablets to one Eliot Schuler. Petitioner alleges that such conduct constituted the practice of osteopathic medicine as to Eliot Schuler, without an active license, and while Respondent's license was suspended in violation of Section 459.013(1)(a) and (b) Florida Statutes (1979), and the provisions of Section 459.015(1)(x), Florida Statutes (1979). 4/ Respondent disputes the allegations that he wrote prescriptions for Percodan tablets to Eliot Schuler without an active license to practice osteopathic medicine. On April 9, 1980, in the Circuit Court for the 11th Judicial Circuit, Respondent pled nolo contendere to all counts of an eight-count information alleging two counts of the unlawful practice of medicine and six counts of sale or delivery of a controlled substance. Respecting this plea, the court withheld adjudication and Respondent was placed on probation initially for a period of eighteen (18) months. Petitioner thus alleges that Respondent thereby violated Section 459.015(1)(c), Florida Statutes (1979). Respondent defends the complaint allegations on the basis that the Board did not automatically suspend his license since he provided the Board with ample notice and a justifiable reason for his failure to attend the required annual appearance as set forth in the April, 1978 Consent Agreement. (Petitioner's Exhibits 1 and 2). In this regard, it is undisputed that the Respondent entered a plea of nolo contendere to two counts of the unlawful practice of medicine and six counts of the sale or delivery of a controlled substance in violation of Chapters 458.327, 459.013 and 893.13, Florida Statutes. Respondent was initially placed on probation for an eighteen month period and an order of modification was subsequently entered which changed his probation from reporting to non-reporting. (Petitioner's composite Exhibit 3). It is also undisputed that the Respondent was advised by Petitioner's Executive Director of the reporting requirements (annually) which was entered by Petitioner and Respondent on April 17, 1978. (Petitioner's Exhibit 4). In this regard, Respondent's prior counsel, Phillip J. Mandina, requested a continuance of the Board's annual meeting to consider Respondent's probationary licensing due to his confinement in a hospital in Miami, Florida. (Petitioner's Exhibit 5). Documentary evidence introduced and received herein reveals that Respondent was a patient at the emergency room at Biscayne Medical Center on January 26, 1979 with a diagnosis of multiple trauma as a result of an automobile accident. Emergency room record notations reveal that Respondent had taken 150 milligrams of Demerol earlier on the 26th of January, 1979 and he had in his possession one empty thirty cc vial of Demerol 50 milligrams/cc and one 20cc vial of Demerol 100 milligrams/cc of which there were approximately 9cc's remaining. A consulting psychologist and an orthopedic surgeon who attended Respondent during his visit at Biscayne Medical Center concluded that Respondent suffered from severe chronic drug addiction and should receive proper treatment for this disease prior to any resumption of treating of patients. (Petitioner's composite Exhibit 6). Respondent submitted a renewal fee of $85.00 for the renewal of his osteopathic medical examiner's license. By letter dated August 28, 1980, the Board's Executive Director, Dorothy Faircloth, notified the Administrator for the Office and Records Administration, Charles R. Beck, that Respondent should not have been allowed to renew his license under the terms of the subject Consent Orders and requested that Respondent return the license issued. It was also indicated that a $85.00 refund would be processed and forwarded to Respondent within approximately four weeks. (Petitioner's Exhibit 7). Finally, Respondent contends that even though he was of the opinion that he possessed an active license, he would not actively engage in the practice of medicine. Respondent is presently involved in a marriage counseling practice and his ultimate goal is that of teaching and conducting therapy sessions. To support his position that he still possessed a license to practice medicine, Respondent pointed out that when he submitted his renewal fee, his license was issued and no action was taken by the Board to retrieve his license until approximately September 12, 1980. Respondent avers that that was his first notice that the Board considered his license suspended due to his failure to appear before the Board annually as per the April 17, 1978 Consent Agreement. Respondent urges that he felt that the request from his former counsel for an abatement of the annual review proceedings of his probationary status had been received and granted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent's license to practice osteopathic medicine be suspended for a period of two (2) years from the date that the Board takes final agency action. RECOMMENDED this 12th day of March, 1981 in Tallahassee, Leon County, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1981.
Findings Of Fact South Dade Osteopathic Medical Center, Inc., d/b/a Suburban Medical Center is an outpatient office facility in South Dade County, Florida. Suburban Medical Ambulatory Surgical Center (the "Am/Surg Center") is a licensed ambulatory surgical center which is operating out of the same building. (Together these entities will hereinafter be referred to as the "Outpatient Center.") The Outpatient Center currently provides outpatient services including ambulatory surgical, diagnostic, radiologic, and laboratory services. The existing building which houses the Outpatient Center was completed in approximately 1980. The building has two floors. The AM/Surg surgical center occupies the second floor of the building. The Outpatient Center currently has approximately 6,000 open patient files and has serviced approximately 12,000 patients since it opened in or about 1980. The license to operate the AM/Surg Center was obtained in approximately 1988. The Outpatient Center operates as an osteopathic facility. However, it does have allopathic physicians on staff. Dr. Jules G. Minkes is an osteopathic physician who owns and controls the Outpatient Center. Dr. Minkes is also the sole owner of Suburban Medical Hospital, Inc. ("Suburban" or the "Applicant"), the applicant in this case. On March 29, 1989, Suburban filed an application for a Certificate of Need to convert the existing Outpatient Center into a 36-bed osteopathic acute care hospital. The Application was assigned CON #5868. The Executive Summary contained in the Application summarizes the project as follows: The proposal is to convert the 26 ambulatory surgical recovery beds into hospital beds. The surgi-center and 26 beds are on the second floor of the facility which was constructed in accordance with hospital code specifications. Thus, conversation of the center into a hospital will primarily involve certain struc- tural changes on the first floor of the center to meet code specifications. The project will also require additional construction for ten ICU/CCU beds, a cafeteria, and certain engi- neering equipment. The Center will continue to offer its current out-patient services. The evidence at the hearing created some confusion and questions as to the Applicant's intended operation of the proposed project. At the hearing, Dr. Minkes testified that the AM/Surg Center will continue to exist and operate in the same physical structure as the proposed hospital. The plan for continuing the AM/Surg Center is not detailed in the Application. It is not clear where the ambulatory surgical center would be located in the converted facility and what equipment and/or space would be shared. Furthermore, it is not clear to what extent the revenues and expenses for the ambulatory surgical center are included within the projections set forth in the Application. It should be noted that, under existing law, an ambulatory surgical center cannot be part of a hospital. See, Section 395.002(2)(a), Florida Statutes (1989). (This issue is discussed in more detail in the Conclusions of Law below.) As noted in Gulf Coast Hospital v. Department of Health and Rehabilitative Services, 424 So.2d 86 (Fla. 1st DCA, 1982), osteopathy and allopathy are two primary and separate schools of medicine which differ substantially in philosophy and practice. Doctors of medicine are licensed under Chapter 458, Florida Statutes. Osteopathic physicians are licensed under Chapter 459, Florida Statutes. The practice of medicine is defined in Section 458.305, Florida Statutes as the "diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition." Allopathy is defined in Webster's Third New International Dictionary as "a system of medical practice that aims to combat disease by use of remedies producing effects different from those produced by the special disease treated." 424 So.2d at 89 n.8. Section 459.003(3), Florida Statutes, (1989) defines osteopathic medicine as the "diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or any other physical or mental condition which practice is based in part upon educational standards and requirements which emphasis the importance of the musculoskeletal structure and manipulative therapy in the maintenance and restoration of health." Osteopathic medicine places great emphasis upon the health of the musculoskeletal system as a condition of healing, and employs techniques of manipulation of muscles and joints in the process of therapy for illness. As explained by Dr. Minkes, osteopathic medicine is a distinct school of practice that embodies a philosophy based on a holistic approach that integrates the biomechanical and structural aspects of the body's function in all aspects of the functioning of the body. Dr. Minkes testified that it is his intention to seek accreditation for the proposed facility from the American Osteopathic Association and to operate the proposed hospital as an osteopathic hospital. Suburban intends to locate its proposed facility in conjunction with the existing Outpatient Center at the intersection of U.S. 1 and S.W. 97th Avenue. This location lies within Subdistrict 4 of HRS Health Planning District XI near the dividing line between Subdistricts 4 and 5. Baptist and South Miami are general acute care hospitals located in southern Dade County, Florida. The primary service area proposed by Suburban overlaps the primary service areas of Baptist and South Miami. Suburban's proposed service area is "bounded by S.W. 88th Street (Kendall Drive) and Homestead, Florida City and the upper Keys on the north and south; Biscayne Bay and the Everglades on the east and west: Subdistrict 4 from Kendall Drive south, subdistrict 5a, northern subdistrict 5(b)." There is an existing osteopathic hospital in District XI. That hospital, Westchester General Hospital ("Westchester"), is also located in Subdistrict 4. Currently, Westchester is licensed for 100 beds. It is an approved osteopathic teaching hospital and intern training hospital. Until 1989, there was another osteopathic hospital located in District XI. Southeastern Medical Center ("Southeastern") was a 224 bed facility that was approved for delicensure by HRS as of May 9, 1989. Southeastern was located in North Miami Beach Florida, close to the Broward County line. In 1983, South Dade Osteopathic Medical Center, Inc., one of the corporations owned and controlled by Dr. Jules Minkes, filed a Certificate of Need Application for a 150 bed osteopathic teaching hospital at the same site as the current Suburban proposal. The prior application was subsequently amended to 100 beds. After HRS denied that prior application, a hearing was held leading to the entry of a Final Order dated October 11, 1985 denying the application. See, South Dade Osteopathic Medical Center, Inc., d/b/a Suburban Medical Center vs. DHRS, 7 FALR 5686. (This case will hereinafter be referred to as the "South Dade" case.) In denying the prior application for a 100-bed osteopathic hospital, the Hearing Officer in the South Dade case noted the existence of the two osteopathic facilities in the district (Westchester and Southeastern) and found their occupancy rates had been significantly lower than capacity in the immediate years preceeding that application. He also noted that those occupancy rates were very similar to the occupancy rates for allopathic hospitals in the area. In 1981, the occupancy for all acute care hospitals in District XI was 67.4 percent. The occupancy rate for Westchester was 67.8 percent and Southeastern's occupancy rate was 61.3. In 1982, the overall occupancy for all District XI hospitals was 66.6 percent, Westchester's occupancy dropped to 65.8 percent and Southeastern's occupancy rate dropped to 58.4 percent. The Hearing Officer in the South Dade case noted that, in 1984, the occupancy rate for osteopathic beds had decreased even further. Based upon this evidence, the Hearing Officer found that there was an excess number of osteopathic beds in District XI in the years preceding that hearing. In the Recommended Order denying South Dade's application, the Hearing Officer noted: ...The cause of these lower use rates have been causes that apply equally to osteopathic and allopathic hospitals, thus leading to the conclusion that the lack of need shown by the above data will probably persist for several years into the future. All acute care hospitals have lost patients due to growth of alternatives to inpatient care, such as nursing homes, rehabilitation centers, outpatient surgical centers, and the like. Additionally, medicare policy changes have reduced the length of stay at all acute care hospitals. There is no compelling evidence on this record that osteopathic hospitals will not suffer from diminished need from these market forces in the same way that allopathic hospitals have suffered...7 FALR at 5698. The South Dade Recommended Order predicted that the lack of need for new acute care facilities of any affiliation was destined to continue for several years into the future. That prediction has proven to be correct. The evidence in this proceeding demonstrated that many of the same forces that caused reduced occupancy at both allopathic and osteopathic hospitals in 1984 continue to influence occupancy at both allopathic and osteopathic facilities. Without question, the overall occupancy rates and number of patient days in District XI acute care facilities has been declining significantly since 1984. The average annual occupancy rate for all acute care facilities in District XI was approximately 51 percent in 1988. The occupancy in Dade County alone was approximately 47 percent. These figures are well below the 80 percent efficiency standard established by HRS for an acute care facility. This decline can be attributed to a number a factors including the development of diagnostic related groups ("DRG's") for Medicare reimbursement. Osteopathic facilities have not been immune to this decline. Indeed, since 1984, the occupancy for the two existing osteopathic facilities in District XI decreased at a significantly greater rate than occupancy in allopathic facilities. In 1984, Westchester's occupancy was 46.7 percent. Westchester's average occupancy in 1987 was approximately 30.5 percent. By the end of the calendar year 1988, that occupancy had declined to 27 percent. Similarly, Southeastern Medical Center experienced declining occupancies from 1984 until its closure. Occupancy at Southeastern in 1984 was approximately 60 percent. Southeastern's average utilization rate for 1988 was only 20.3 percent. These trends are consistent with the statewide occupancy of osteopathic facilities which has been dropping at a rate equal to, if not greater, than, that of allopathic facilities. Suburban attempted to explain the closure of Southeastern through the testimony of several witnesses who were affiliated with that facility. Petitioner contends that the decline and eventual closing of Southeastern was the result of a conscious decision on the part of the owner of that facility, AMI, to focus its resources and efforts on the development of a nearby allopathic hospital which it also owned. While management decisions and/or problems may have contributed to the declining occupancy and ultimate closure of Southeastern, it is clear that the facility was also impacted by many of the factors that have contributed to the overall decline in occupancy at acute care facilities throughout the District. Based on the evidence presented at the hearing, it is concluded that there was an excess number of licensed osteopathic beds in the District at least prior to the time of the delicensure of Southeastern. With the delicensure of Southeastern, there are now 100 licensed osteopathic beds in the District, all of which are located at Westchester in the same Subdistrict as the proposed project. Petitioner presented extensive testimony regarding the perceived inadequacy of Westchester to meet the need for osteopathic services in the District. That testimony indicates that some osteopathic physicians are unhappy with the management philosophy of Westchester and they feel they are unable to provide quality osteopathic care in that facility. Most of the complaints about the care and treatment at Westchester were voiced by Dr. Minkes and Dr. Hershmann. Both of these physicians are expected to have a significant financial investment in the proposed facility. Several osteopathic physicians who do not have an interest in the proposed project testified that they did not have a problem with the quality of care at Westchester. Thus, while there may be some minor and/or individual problems with Westchester, the evidence was not sufficiently compelling to establish that the occupancy problems at Westchester are due to problems and/or inadequacies that facility. In other words, while some osteopathic physicians may prefer to treat their patients in a new, more modern facility, Westchester has not been shown to be so inadequate that it should be replaced or supplemented by the proposed project. The HRS Office of Licensure and Certification has not received any complaints against Westchester regarding the facility's physical plant or quality of care. Furthermore, Westchester's license is in good standing and it is accredited by the JCAH and the AOA. Petitioner presented hearsay evidence suggesting that a number of the beds at Westchester are not being utilized because of space limitations and that a number of the beds are contained in undesirable four bed rooms. As a result, Petitioner suggests that Westchester's functional bed count should be considered in the neighborhood of 50 rather than 100 beds. If this argument is accepted, Westchester's occupancy rates would not appear nearly as dismal. However, the evidence was insufficient to justify this conclusion. Westchester is presently licensed for 100 beds and no evidence was presented to establish that the hospital is not trying to fill all those beds. Petitioner also contends that Westchester has ceased functioning as a distinct osteopathic facility. The evidence was insufficient to support this conclusion. The testimony from several osteopathic physicians indicated that they still admit patients to Westchester. Similar contentions regarding Westchester were made in the South Dade case. In that earlier proceeding, the Hearing Officer found: ...While the foregoing is evidence that there are problems at Westchester for the physicians who testified, these problems were not proven with sufficient specificity and have not been shown to be such for this Hearing Officer to conclude that Westchester is so inadequate that it should be replaced by the hospital proposed by Petitioner. Nor is the evidence sufficient for the Hearing Officer to conclude that the low use rate at Westchester is due solely to inadequate health care at Westchester. As stated above, the record evidence indicates that the use rate at Westchester is quite similar to the use rates at allopathic hospitals in the District, which is consistent with the conclusion that the lower use rate at Westchester is caused by the same diminished need. Further, the use rate at Westchester is quite similar to the use rate at Southeastern Medical Center. On this record, there is no indication that Southeastern Medical Center is other than an adequate health care facility. The similarity in use rates, therefore, leads one to the conclusion that the use rate at Westchester is driven primarily by the same force that drives the use rate at Southeastern; lack of need or demand by osteopathic patients. 7 FALR 5702 The evidence in this case was similarly insufficient to attribute the low occupancy at Westchester to other than market forces. While the low occupancy rates at Westchester may be due in part to problems with that facility and reluctance on the part of some osteopathic physicians to utilize that hospital, the evidence indicates that both Southeastern and Westchester have experienced declining enrollments for many of the same reasons that all acute care facilities in District XI have. The evidence did establish that osteopathic physicians experience some difficulties in practicing osteopathy in allopathic facilities and that the facilities of many allopathic institutions are not conducive to osteopathic treatment. Most physical therapists at allopathic facilities are not trained to provide osteopathic treatment. In addition, few osteopathic specialists have obtained staff privileges at allopathic facilities. On the other hand, it appears that many of the difficulties and barriers that osteopathic physicians have historically experienced are being eroded. Virtually all of the osteopathic physicians who testified had staff privileges at several allopathic facilities and regularly admit patients to those facilities. Several of the osteopathic physicians who testified are practicing in partnership with or in association with allopathic physicians. Suburban presented the testimony of several osteopathic physicians who testified that additional osteopathic hospitals are needed in the District in order to enhance the survivability of osteopathy as a distinct approach to health care. Such facilities enable osteopathic physicians to learn and practice together and consult with osteopathic specialists in a forum that is supportive of osteopathy. The evidence established that approval of the proposed facility would, to some degree, enhance the survivability of osteopathy as a distinct and separate alternative treatment mode in the District. However, no evidence was presented to demonstrate that individuals seeking osteopathic care are currently being denied such services. While a significant number of osteopathic physicians have indicated an intention to use the proposed facility if it is approved (even though many of them do not use the existing osteopathic facility in the District, Westchester,) the evidence was insufficient to establish the need for an additional 36 osteopathic beds in the District. Moreover, as discussed in more detail below, the evidence did not establish that Suburban's Application satisfies the remaining criteria necessary for the issuance of a CON. Section 381.704(1), Florida Statutes (1989), recognizes that the review of CON applications includes consideration of the state and local Health Plans. Neither the Local Health Plan nor the State Health Plan specifically address osteopathic facilities. Therefore, Petitioner contends that the State and Local Health Plans are largely irrelevant to this case. This legal argument is addressed in the Conclusions of Law below. The Local Health Plan for District XI is prepared by the Health Council of South Florida. Linda Quick, Executive Director of the Health Council of South Florida testified that the Health Council does not support the construction of any new hospitals in the District. The Health Council opposes the construction of any new hospitals regardless of whether they are osteopathic or allopathic. The Health Council has prepared a booklet entitled District XI CON Allocation Factors Report for 1989. That booklet does not contain any CON allocation factors for osteopathic facilities. There are approximately thirty-two acute care facilities in the District. Utilizing the state's bed need methodology, the Health Council has concluded that there are nearly two thousand too many acute care hospital beds in the District through 1993. This determination does not differentiate between osteopathic and allopathic acute care beds. Because of the existing excess number of beds in the District, Linda Quick emphasized the need to fully explore alternatives to the construction of a new acute care facility. Such alternatives could include the acquisition of an existing facility, establishing a working relationship with an existing provider, increasing utilization at Westchester or arranging a joint venture with a licensed hospital. The Petitioner's failure to fully explore these alternatives weighs against approval of Suburban's Application. The purpose of the Local Health Plan is to describe the existing health care system, the existing population and its health status. The Plan also establishes goals and objectives for the growth, development and change of the local health system. The Local Health Plan sets forth general criteria and policies regarding health planning for services to individuals within the area. One of those goals is for the District to have a licensed bed capacity of no more than five beds per one thousand population by 1993. The State Health Plan calls for an even lower ratio. Currently, the ratio of acute care beds to the population is well in excess of five per one thousand. Approval of Suburban's Application would increase the number of acute care beds and, therefore, would be contrary to this goal of the Local Health Plan. However, it should be noted that this goal does not differentiate between osteopathic and allopathic acute care beds. Another pertinent goal of the Local Health Plan for District XI is to make services in the community geographically and financially accessible to all segments of the resident population. Because the proposed facility is located in the same Subdistrict as Westchester, it does not appear that the proposed project would significantly improve geographic accessibility to osteopathic services. Similarly, because of the large number of hospitals in the District, it does not appear that this proposed project would measurably improve the accessibility to acute care services. Section 381.705, Florida Statutes, sets forth the specific criteria to be considered in the review of a CON application. The first criteria to be considered under Section 381.705(1)(a) is the need for the proposed project in relation to the State and Local Health Plans. In assessing need, it is necessary to also consider the provisions of Section 381.713(2), Florida Statutes which provides that the need for an osteopathic hospital "shall be determined on the basis of the need for and availability of osteopathic services and osteopathic acute care hospitals in the District..." The Application cites the First District Court of Appeal's decision in Gulf Coast Hospital v. Department of Health and Rehabilitative Services, 424 So.2d 86, for the assumption that approximately ten percent of the population of the United States prefers to be treated by osteopathic physicians. Based upon this assumption and the most recent population estimate for Dade County (1.829 million as of 1987), Petitioner suggests in its Application that there should actually be 750 osteopathic beds in Dade County. No evidence was presented to support the assumption that ten percent of the population in the District prefers to be treated by osteopathic physicians. Indeed, the evidence of occupancy at osteopathic facilities in Dade County indicates that the ten percent assumption is vastly overstated. In 1985, only 2.4 percent of the total patient days for all hospitals in District XI were in osteopathic facilities. In 1986, that number decreased to 2.1 percent and in 1987 it decreased to 1.8 percent. These rates coincide with the declining occupancy rates at the existing osteopathic facilities in the District during this period. These facts indicate that the assumption that ten percent of the patients prefer osteopathic facilities is not accurate, at least in District XI. HRS has not adopted a rule or an official methodology to calculate osteopathic bed need. The need methodology set forth in Rule 10-5.011(1)(m) for calculating acute care bed need is not applicable to osteopathic facilities. The Application does not present any methodology to demonstrate osteopathic need in the District. At the hearing in this case, Suburban attempted to demonstrate the need for additional osteopathic beds in Dade and Monroe counties through the testimony of Dr. Howard Fagin, who was accepted as an expert in health planning, bed need methodology development and health economics. Dr. Fagin presented several calculations of "need" which Petitioner contends support the conclusion of need set forth in the Application. None of Dr. Fagin's calculations were included in the Application. Dr. Fagin's calculations used current hospital and physician utilization data and, by applying certain assumptions, attempt to project osteopathic need and/or demand in the District for five years into the future. In other words, Dr. Fagin attempted to develope a methodology specifically geared to calculate osteopathic need over a five-year planning horizon. Dr. Fagin set forth five different approaches for calculating osteopathic need. Most of these approaches had been considered and rejected by HRS in connection with other applications for osteopathic facilities. Intervenors and Respondent have painstakingly pointed out the deficiencies in Dr. Fagin's testimony. While their criticisms have merit, the shortcomings in the methodologies submitted by Dr. Fagin must be considered in the context of Section 381.713(2), Florida Statutes, and the lack of an approved and/or workable methodology for determining osteopathic need. It does not appear that there is a reasonably identifiable osteopathic unit of service for planning purposes. It is extremely difficult, if not impossible, to measure osteopathic need in accordance with the usual "normative" methodologies used to determine need for discreet services. However, the burden is on the Applicant to overcome these obstacles and present persuasive evidence of the need for the proposed project. Insufficient evidence was presented to accomplish this task. Intervenors and Respondents suggest that only those patients who receive osteopathic manipulative therapy during their stay in the hospital should be considered in determining "osteopathic patient days." They contend that such manipulative therapy is the only specific procedure measurable and monitored as distinctly osteopathic. The Hospital Cost Containment Board's data indicates that only two percent of the patients discharged from "osteopathic" hospitals received osteopathic manipulative therapy during their hospital stay. However, the evidence established that osteopathic care includes more than manipulative therapy. Thus, utilizing this unit of measure would significantly understate osteopathic need. All of the projections prepared by Dr. Fagin rely upon an assumption that "osteopathic patient days" are an identifiable unit of service which can be distinguished from allopathic patient days. There are several problems with this assumption. Dr. Fagin obtained the number of "osteopathic patient days" by simply taking the number of days in osteopathic designated facilities. However, not all patient days in an osteopathic hospital are "osteopathic patient days." There are clearly a number of allopathic physicians who admit and treat patients in osteopathic facilities. Indeed, at some osteopathic facilities, allopathic physicians constitute a majority of the staff. While Dr. Fagin contends that the number of allopathic admissions to osteopathic hospitals is a "wash" with the number of osteopathic admissions to allopathic hospitals, no evidence was presented to support this assumption. Patient days is a generally recognized unit of service for inpatient care and acute care beds. Typically, patient days are broken down into discreet units of service, i.e., obstetrical, psychiatric, pediatric, etc., relating to the underlying epidemiology of the population. Osteopathy is an approach to the practice of medicine rather than a specific clinical service. Osteopathy can not be measured in the same manner as a clinical service. Mixed staff hospitals and the inability to isolate a discreet unit of measurement such as an osteopathic patient day make it virtually impossible to quantify need for an osteopathic facility utilizing a traditional "normative" approach to planning. A "normative" approach provides a projection based on an estimate of the number of units of service or resources that should be in place. It is based on a number of unit of services related to an underlying need of the population. Dr. Fagin's forecast of "osteopathic patient days" includes the "need" for osteopathic beds to provide patient services in several specialized areas of care which will not be offered in the proposed project. For example, the proposed project will not offer obstetrics, psychiatry, pediatrics, tertiary care services, or cardiac catheterization. "Osteopathic patient days" as utilized by Dr. Fagin includes all of these services because he did not isolate those services that will be offered by the proposed facility. At best, Dr. Fagin's calculations show how many beds would be utilized at an osteopathic hospital if it achieved the average utilization of other osteopathic facilities. There was no showing that the average utilization at other osteopathic hospitals is appropriate or reflective of need. Thus, these methodologies do not measure need or demand for osteopathic services in the true sense of the word. In making his calculations, Dr. Fagin relied upon population figures published by the Executive Office of the Governor on May 15, 1989. The Intervenors and Respondent objected to the testimony and contended that only the population projections which had been released at the time the Application was filed could be used in connection with this Application. The earlier projection figures were released on January 1, 1989. These objections are discussed in more detail in the Conclusions of Law below. The evidence indicates that there would be no material changes in Dr. Fagin's conclusions regardless of whether the January 1st or May 15th projections are used. From 1980-1989, District XI experienced a population growth of approximately 14.6 percent and from 1990 through 1994 the projected increase is 22.1 percent. Thus, the population in the District is growing significantly. There is less than a one percent difference in the January and May population projections. In addition to the general limitations set forth above, there are several specific flaws contained in certain of the calculations performed by Dr. Fagin. The first methodology employed by Dr. Fagin was referred to as Florida Osteopathic Utilization Based Bed Need. This methodology divided the 1988 Florida population by the number of "osteopathic patient days" in the state that year to obtain a rate of 31.62 patient days per one thousand population. "Osteopathic patient days" was determined from the Florida Health Care Cost Containment Board, 1988 Hospital Budget Data. The rate of 31.62 osteopathic patient days was then multiplied by the projected 1994 District XI population, resulting in a projection of 65,192 osteopathic patient days in District XI in 1994. The projected number of osteopathic beds needed in District XI to accommodate these patient days was accomplished by dividing the projected patient days by 365 to arrive at an average daily census of 179. The average daily census was then divided by the HRS standard of eighty percent occupancy for efficient operations, resulting in a projected need of 223 osteopathic beds in District XI in 1994. Subtracting the 100 licensed beds at Westchester, this methodology results in a projected need of 123 additional osteopathic beds by the year 1994. This first methodology suffers from the deficiencies noted in Findings of Fact 53-58 above. In addition, the state wide total of osteopathic patient days for purposes of this first methodology was obtained from fourteen "osteopathic" hospitals. However, the evidence raises serious doubt as to the reliability of this data. At least one of those hospitals is no longer osteopathic and another one of the hospitals includes a utilization rate of ninety-five percent for a service (psychiatric) which will not be offered by the proposed facility. The next methodology submitted by Dr. Fagin was entitled Florida Osteopathic Physician Based Bed Need. This method calculated patient days per osteopathic physician in the State of Florida by dividing the 1988 "osteopathic patient days" by the number of osteopathic physicians in 1989. Patient days per osteopathic physician was then multiplied by the projected number of osteopathic physicians in District XI in 1994 to arrive at a projection of 66,544 osteopathic patient days in District XI in 1994. The projected patient days were then divided by 365 to arrive at an average daily census of 182. Applying the occupancy standard of eighty percent, this method projects 228 osteopathic beds will be needed in District XI in 1994. Again, subtracting the beds at Westchester, Dr. Fagin concludes that there is a net bed need of 128 beds. In addition to the overall problems noted above with respect to identification of "osteopathic patient days," this calculation includes an overly optimistic assumption of the number of osteopathic physicians that can be expected in District XI. In making this calculation, Dr. Fagin assumed a thirty percent increase in the number of osteopathic physicians in District XI from 1989 to 1994. This assumption is predicated on an expectation that a large number of graduates from Southeastern College of Osteopathic Medicine ("SECOM") would remain in the area and there would also be an influx of practicing osteopaths moving into the area. Dr. Fagin based his assumption, in part, on data provided by the Florida Health Care Atlas which showed that there were 198 osteopathic physicians in District XI in 1986, 180 in 1987, and 256 in 1989. Dr. Fagin attributes the apparent increase in osteopathic physicians in the District from 1987 to 1989 on the influx of the first graduating class from the SECOM in 1988. However, the 1986 and 1987 data reflected only active osteopathic physicians whereas the 1989 data reflected all licensed osteopaths. In other words, the 1986 and 1987 data did not include retired and inactive physicians whereas the 1989 data did. No reliable evidence was presented to compare the number of active osteopathic physicians to any year subsequent to 1987. Furthermore, SECOM's first graduating class actually occurred in 1985, not 1988. Additional classes also graduated in 1986 and 1987. Therefore, Dr. Fagin's assumption that SECOM graduates will increase the ranks of osteopathic physicians in the district is not necessarily correct. In addition, these projections assume new physicians in the area will be as productive as established physicians, which is unlikely to be the case. In sum, Dr. Fagin's assumptions as to the expected growth and the number of osteopathic physicians in District XI during the next five years is predicated on several erroneous assumptions. The next methodology presented by Dr. Fagin was entitled District XI Osteopathic Utilization Based Bed Need. Dr. Fagin projected a minimum and maximum number of expected osteopathic patient days in 1994 in the District based upon the actual utilization of existing osteopathic facilities in the District (Westchester and Southeastern) in 1986 and 1987. He calculated the number of "osteopathic patient days" in the District in those years and divided it into the District population to obtain rates of 24.67 and 19.72 patient days per one thousand population. These rates were multiplied by the projected District population in 1994, then divided by 365 and achieved an average daily census of between 139 and 111. Applying the eighty percent occupancy standard, Dr. Fagin calculated that there would be a need in District XI for between 174 and 139 osteopathic beds. After subtracting the existing beds at Westchester, he calculated the net bed need in 1994 to be between 74 and 39 beds. In addition to suffering from the general defects noted above, this approach is unnecessarily narrow. This methodology does not include any years prior to 1986 because Dr. Fagin did not feel that DRG's fully impacted on occupancy rates prior to that time. Dr. Fagin eliminated any years after 1987 on the grounds that the impending closure of Southeastern introduced too many variables into the equation. By eliminating all other years, this methodology provides a limited view of actual utilization and ignores the continuing decline in the utilization rate of osteopathic facilities in the District dating back to the 1970's. Dr. Fagin's next methodology was entitled Osteopathic Physician Based Bed Need. The "osteopathic patient days" from the existing facilities in District XI in 1986 and 1987 were divided by the number of osteopathic physicians in the District. The patient days per physician were then multiplied by the projected number of osteopathic physicians in the District in 1994 to arrive at an estimate of maximum and minimum patient days in 1994. Dividing by 365, an average daily census of between 210 and 188 was projected. Applying the eighty percent occupancy standard, Dr. Fagin concluded there would be a need for between 263 and 235 osteopathic beds in District XI in 1994. After the 100 beds at Westchester were subtracted, a net need of 163 and 135 beds was calculated. This methodology suffers from the same deficiencies as those noted in Findings of Fact 53 through 59 and 63 through 65 above. Dr. Fagin's final projections were based on the relationship of the overall bed need in District XI to Osteopathic Bed Need. In 1986, osteopathic facilities in the District accounted for 2.1 percent of the total patient days. This figure was 1.8 percent in 1987. Applying these percentages to HRS' projected total bed need for the District in 1994, Dr. Fagin concluded that a minimum of 159 to 137 osteopathic beds were needed. After subtracting the beds at Westchester, he calculated a net need of between 59 and 37 beds. This approach suffers from the deficiencies noted in Findings of Fact 55 through 59 above. In addition, it does not account for the continuing decline in occupancy at osteopathic facilities in the District. Suburban's Application includes over 2,000 signatures from members of the community indicating their support for the proposed project. Those petitions do not specifically indicate support for an osteopathic facility. Instead, the petitions include the following statement: "I support the establishment of Suburban Medical Hospital in the Perrine/Cutler Ridge area." It is clear from the evidence that the desire of osteopathic physicians to have a new facility in the area and the reputation of Dr. Minkes will attract a number of admissions to the proposed project. Suburban presented extensive testimony from osteopathic physicians regarding their interest in the project and their intent to refer patients to the proposed facility if it is built. Physician referral plays a large role in determining where a patient is admitted. Thus, it does appear that the proposed project can be expected to achieve a higher occupancy rate than Westchester or other acute care facilities in the area. However, this expected occupancy does not in and of itself establish need. The second review criteria set forth in Section 381.705(1), deals with the availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the district. For purposes of reviewing applications for osteopathic acute care facilities, HRS has interpreted "like and existing health care services" to include all acute care facilities irrespective of their orientation towards osteopathic or allopathic care. In evaluating this criteria, the goals of the local Health Plan are pertinent. One of the goals set forth in the local Health Plan is an access standard that an acute care hospital should be available to all residents of the District within 30 minutes average driving time. The Plan does not set forth a goal for access to osteopathic facilities. The existing hospitals in the District are sufficient to satisfy this criteria without the need to add another hospital. In accordance with the State Health Plan, HRS has concluded that the efficient level of utilization for acute care services is eighty percent occupancy. The utilization rate for osteopathic beds in Dade County is twenty- seven percent. Thus, the effective utilization standard is not met regardless of whether it is applied to all acute care hospitals or only osteopathic hospitals. Section 381.705(1)(c), Florida Statutes, requires a consideration of the Applicant's ability to provide quality care. HRS did not dispute Suburban's ability to provide quality osteopathic medical care. The Intervenors and Respondents have questioned whether quality care could be provided in the project as it is currently planned since the physical layout of the proposed facility does not meet hospital code requirements. Those deficiencies are discussed in more detail in Findings of Fact 97 through 101 below. Certainly, if those deficiencies are not corrected, the quality of care could be affected. Although the parties stipulated that Section 381.705(1)(e), Florida Statutes, remained at issue in this proceeding, no evidence was presented with respect to this criteria. Suburban's Application does not involve joint, cooperative, or shared health care resources and, therefore, there are no probable economies or improvements in service that may be derrived from its proposal. Section 381.705(1)(g), Florida Statutes, requires a consideration of the need for research and educational facilities. The existing Outpatient Center currently provides externship training for SECOM students. While the proposed facility may provide some additional training opportunities for osteopathic students, the evidence did not demonstrate that any such additional benefits would be significant. Section 381.705(h) requires a consideration of the availability of resources, including health manpower, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation. It also requires a consideration of the effects the project will have on clinical needs of health professional training programs in the District and the extent to which the services will be accessible to schools for health professions in the service district for training purposes if such services are available in a limited number of facilities. Finally, this Section requires a consideration of the availability of alternative uses of the resources for the provision of other health services and the extent to which the proposed services will be accessible to all residents of the District. The evidence indicates that there is a current shortage in the District of nurses and skilled hospital personnel, such as physical therapists, laboratory technicians, radiation therapy technicians, respiratory therapists and pharmacists. This shortage of available health care personnel is ongoing and long standing. While a number of existing employees of the Outpatient Center have indicated a willingness to become employees of the proposed project at the salary stated in the Application, they constitute only 35% of the projected staff for the proposed project. It does not appear that any of the existing staff are required to work weekends and nights on a regular basis. Such positions are likely to be the most difficult to fill. Petitioner has not demonstrated an ability to recruit and hire the additional skilled staff necessary to run a hospital on a full-time basis. Approval of this project is likely to exacerbate the existing shortage. It is also not clear from the Application whether Suburban intends to hire a hospital administrator. No such position is reflected on the tables in the Application setting forth "manpower requirements." The evidence presented at the hearing was very sketchy as to the availability of funds for capital and operating expenditures. Suburban's audited financial statements only show $10,000.00 cash on hand, all of which was donated by Dr. Minkes. Thus, Suburban has virtually no capital resources except to the extent that it might be able to borrow funds for capital expenditures and operating expenses. The Applicant does not own the property on which the proposed project will be located. No evidence was presented to establish the basis upon which the proposed project will be occupying the land and existing facility. The existing Outpatient Center and the land on which it is located is owned by Dr. Minkes and subject to a first mortgage of 1.5 million dollars. Monthly interest payments on this mortgage currently run between $25,000 and $35,000. The proposed project budget does not provide for the payoff of this mortgage. Dr. Minkes contended that the interest/amortization figures on the long-term feasibility table contained in the Application included the funds necessary to service the underlying mortgage on the property. However, no specific breakdown of this figure was provided. Furthermore, no clear explanation was given as to the basis upon which the proposed hospital would occupy the land and existing facility. Thus, it is not clear whether the existing mortgage would be paid off, some lease arrangement would be entered into between Suburban and Dr. Minkes as owner of the property, or whether some other arrangement would be made. It is not clear from the initial Application whether Suburban intends to finance 100% of this project. Lending institutions typically are not willing to assume all of the risk for a proposed project and, therefore, will usually only lend between 60 to 70% of the project cost. While the Applicant suggests that private investors may participate in the financing of the project, the only evidence introduced to support this contention was the testimony of Dr. Minkes that he had talked with various osteopathic physicians who had indicated an interest in participating as private investors and the testimony of Dr. Hershman who indicated that he was willing to commit $100,000.00 to the project. These statements do not provide a sufficient basis to conclude that Suburban has the resources available to meet the initial capital expenditures for this project. Dr. Minkes suggested that one possible way to raise funds for the project would be through a limited partnership offering or a private placement. However, the estimated project costs in the Application does not provide for the cost of registering a limited partnership or otherwise raising money through private investment. As part of its Application, Suburban submitted a letter from a real estate investment banking firm, Sonnenblick-Goldman Southeast Corp., indicating an "interest in exploring arranging financing" for 4.1 million dollars for the proposed project. At the hearing, Petitioner also proffered another "letter of interest" from James F. Perry of Professional Bancorp Mortgage indicating an interest in processing a loan application for the project. This letter was not part of the Application and does not provide any additional proof that the resources are available to complete this project. Both letters merely reflect an interest in seeking a loan on behalf of Suburban. Neither of these letters establishes that Suburban has secured sufficient funds to finance the proposed capital expenditure. The Application indicates that the proposed facility would treat all patients requiring medical care regardless of ability to pay and would implement payment schedules based on the patient's ability. The Application contains a projected distribution of fifty percent Medicare patients, ten percent Medicaid patients, and three percent indigent. However, no competent evidence was presented to support the reasonableness of this projected patient mix. The issues related to training are discussed in Findings of Fact 75 above. Section 381.705(1)(j), Florida Statutes, requires a consideration of the immediate and long-term financial feasibility of the proposal. As set forth in Findings of Fact 76 through 82 above, Petitioner has not demonstrated that it has the resources available to complete the project. Therefore, there are significant questions regarding the short-term feasibility of the project. In addition, as set forth in Findings of Fact 91 through 101, below, there are significant questions as to whether the project can be completed within the budgeted cost of $4,085,780 and still meet hospital code requirements. The long term financial feasibility and the pro forma projections contained in the Application were not verified by any direct testimony at the final hearing. Suburban's financial feasibility expert, Mr. Darrell Lumpkin, did not prepare the pro formas contained in the Application. Mr. Lumpkin was not hired by Suburban until several months after the Application was filed and shortly before the hearing in this cause. Suburban conceded that Mr. Lumpkin did not base his financial feasibility analysis on the Application filed by Suburban and that he would not testify regarding the figures contained in the Application. Mr. Lumpkin prepared a feasibility study generally applicable to any 36-bed proprietary hospital in the State. His study utilizes occupancy rates of 50% for year one and 60% for year two. In presenting his testimony concerning operating expenses, Mr. Lumpkin looked only to the average charges, average deductions from revenue, average contractual allowances, etc., from all proprietary hospitals in Florida. He did not adjust these average figures to reflect the payor mix anticipated at Suburban or to compensate for the small size of Suburban. He was provided with occupancy figures and salary costs to use in making his projections. However, the reasonableness of these figures was never established. While Petitioner contended that Mr. Lumpkin's study confirmed the reasonableness of the pro formas contained in the Application, there were several significant differences between Mr. Lumpkin's study and the information contained in the Application. For example, the Application assumes a first year occupancy of 38%; Mr. Lumpkin's study assumes a first year occupancy of 50%. Furthermore, Mr. Lumpkin's first year revenue projections and average daily charges were significantly higher than the figures contained in the Application. The reasonableness of the figures used by Mr. Lumpkin are also questionable. He used HCCB data which contained consolidated information from all proprietary hospitals rather than utilizing information that was more closely tailored to the proposed project. In determining revenue deductions, he utilized statewide averages which contain many variables. In sum, Mr. Lumpkin's study is of minimal help in evaluating the financial feasibility of this project. The evidence did not establish the reasonableness of the income and expense projections contained in the Application. Moreover, there are several areas where the Application omits or understates expected operating costs. For example, the benefits to be provided to employees, as stated in the pro forma projections, are only 8% of salaries. This percentage would be insufficient to cover the cost of the statutorily mandated benefits of Social Security and unemployment insurance. Furthermore, this benefit level would not cover Workers' Compensation, health insurance, disability insurance, retirement benefits or life insurance. While Suburban suggested that some or all these costs were built into the salary figures rather then the benefit numbers, no specific evidence was presented to support or explain this position. The Application assumes that financing can be obtained at a 10% interest rate. However, the evidence suggests that, at the time the Application was filed and as of the date of the hearing, this rate was probably overly optimistic. It is possible, indeed likely, that Suburban will have to borrow money at a rate in excess of 10%. Therefore, the monthly principal and interest payments may be higher than allotted. The evidence was unclear as to exactly what equipment would be purchased and/or leased for the Project. The Application contains no provision for the purchase of anything other than medical equipment. While a $600,000 contingency is provided, it does not appear that serious consideration has been given to the expected costs for day-to-day items such as furniture, televisions for patient rooms, and similar such items. In addition, it was unclear as to exactly what medical equipment would be required, whether it would be purchased or leased, what equipment in the existing Outpatient Center could be utilized, and whether there would be costs associated with such utilization. Much of the existing equipment serves as security for indebtedness of the Outpatient Center. The Application does not provide for the cost of security or a dietician, both of which are required at an acute care hospital. In sum, Suburban has not proven that the costs set forth in the Application are a reliable estimate of the costs that will necessarily be incurred to open the proposed hospital. The Application provides for ten ICU beds and 26 acute care beds. This bed configuration makes it unlikely that the facility will be able to achieve the utilization rate set forth in the Application. Thus, it is not clear that the projected revenues are reasonable. Section 381.705(1)(l), Florida Statutes, requires a consideration of the "probable impact of the proposed project on the cost of providing health services proposed by the Applicant, ... including... the effects of competition on the supply of health services being proposed and the improvements or innovations in the financing and delivery of health services which foster competition and service to promote quality assurance and cost-effectiveness." It is not clear whether osteopathic health services should be distinguished from allopathic health services in applying this criteria. No evidence was presented as to the probable impact of the proposed project on the cost of providing osteopathic services. Suburban contends that it will be offering health care services at lower cost than allopathic facilities in the area and, therefore, will have a positive effect on the cost of health care in the area and enhance competition to the benefit of health care consumers. To support this contention, Suburban argues that its per diem charges will be less than the Intervenors' and other allopathic facilities per diem charges. However, as indicated above, the evidence was insufficient to establish the reasonableness of the projected costs set forth in the Application. Furthermore, Suburban will not be providing some of the more costly services provided by larger hospitals. Suburban did not present any evidence comparing its charges with facilities providing similar services and/or with small hospitals. A comparison of Suburban's proposed patient charges with the average charges of larger hospitals does not reflect whether Suburban will be a cost-effective provider of acute care services. Finally, the proposed project may somewhat increase the demand for nurses and other skilled health care personnel which could exacerbate existing shortages in the District and lead to higher costs. Section 381.705(1)(m), Florida Statutes, requires a consideration of the costs and methods of the proposed construction. Suburban is proposing to convert an existing outpatient center to an acute care hospital. The Application projects a total project cost of $4,085,780. The total construction costs are estimated at $2,173,600. This sum includes a construction contingency of $190,000. In addition, the total project costs include a working capital reserve of $600,000. Schematic plans of the proposed project to 1/16th inch scale are required to be submitted with the CON Application. The Application is also required to contain certain tables that indicate the functional spaces, square footage per space, and construction cost per square foot for various areas. HRS conducts an architectural review of the submitted plans to determine whether the state requirements for the planned facility can be met. The physical plant requirements for general hospitals in this state are set forth in Rule 10D-28.081, Florida Administrative Code. As noted below, the plans submitted by Suburban fell short of these requirements in many areas. The evidence demonstrates that the proposed project could not be licensed without significant modifications to the submitted architectural plans. Such modifications will necessarily impact upon the cost of the project and, unless rectified, may also impact upon the quality of care rendered in the new facility. The uncertainty surrounding the changes needed to the architectural plans weighs heavily against approving the Application. When the existing building was constructed, Suburban attempted to build it to the then-existing hospital codes. Many aspects of those code requirements have changed and several aspects of the building do not meet the new standards. While Suburban has suggested that, because there is an existing building in place, it may not have to meet all of the current standards, no persuasive evidence or legal precedent was presented to indicate that HRS can or will waive those standards. Bernard Horovitz, the architect who prepared the plans for Petitioner, testified that the plans submitted were conceptual in nature and were not intended as final plans to be held to code standards. According to Mr. Horovitz, the development and refinement of the plans is an ongoing process with HRS that continues even after a Certificate of Need is issued. While Mr. Horovitz felt that the project could be completed in accordance with the applicable code requirements at a price that was not significantly different than the cost estimate set forth in the initial Application, the extent of the deficiencies detailed below raises considerable doubt as to this conclusion. During the review of Suburban's plans, James Gregory, the HRS Architectural Supervisor for the Office of Plans and Construction, discovered that certain essential functions were missing or not indicated in the plans. Some of the omissions and/or deficiencies in the plans submitted with the Application were as follows: Emergency room- The plans indicate that the emergency room is to be constructed in the area of the existing outpatient clinic. The evidence was unclear as to how or whether the outpatient clinic would continue to operate. Moreover, while the Application indicates that the facility would be operating an emergency room on a 24 hour basis, Dr. Minkes' testimony at the hearing raised some question as to whether the proposed hospital would have a fully- staffed emergency room. In any event, the plans provide no clear layout as to how the emergency room and out-patient clinic would be mixed. The plans contain no emergency grade level entrance for ambulance entry, parking or emergency room entry as required by Rule 10D-28.081(12), Florida Administrative Code. There was no reception and control area for the emergency room shown on the plans. Such a reception and control area is required by Rule 10D-28.081.(12)(b). Mr. Gregory testified that during his review he scaled the plans and discovered that the examination and treatment rooms were not large enough to meet the 100 square foot requirement set forth in Rule 10D-28.081(12)(e). Furthermore, Suburban's plans show a corridor running through the emergency room contrary to Rule 10D- 28.081(12)(m). While the cost estimates in the Application indicate extensive remodeling will be done in the area of the outpatient clinic, it is not clear that the remodeling could be completed and the emergency room brought up to code standards within the costs allocated. Furthermore, the evidence was unclear as to the Applicant's intentions with respect to jointly operating an emergency room and an outpatient clinic. Dietary and Dining Facilities - While the Application indicates the conversion of the existing building will include a cafeteria, the evidence at the hearing indicates that a final decision has not been made as to whether Suburban will operate a cafeteria for employees and visitors. In any event, the plans provide for only 720 square feet for the hospital's dietary and dining facilities. This area is too small to meet the functional requirements of Rule 10D-28.081(21). Storage Areas - Suburban's plans only allocate 1,260 square feet for general stores and central service areas. Rule 10D-28.081(25) requires the general storage area of a hospital to contain 20 square feet of storage per patient. In order to meet the general stores requirement, Suburban will only have 540 square feet of storage for central services. This remaining storage area would have to include a decontamination receiving room, a clean workroom to clean medical supplies used in the hospital, storage for clean medical supplies, storage for equipment used in delivery of patient care and a storage room for distribution carts. Furthermore, the plans did not provide for a body holding room as required by Rule 10D-28.081(19)(f). It is unlikely that all of these functions could be fit in the allocated area. Operating rooms - Rule 10D-28.081(10) sets forth a minimum size requirement of 360 square feet for operating rooms. The surgery rooms reflected on the plans do not meet this requirement. Moreover, the surgical area set forth in the plans contains only 75% of the required functions specified in the rule. The area lacked a storage room for splint and traction equipment and a sink for plaster work as required by Rule 10D-28.081(10)(b) if orthopedic surgery is to be performed. The proposed recovery room did not provide for an isolation room with an anteroom for infected patients, a medication administrative station, a supervisor's office, a nurses station, two scrub stations for each operating room, an equipment storage room of at least 100 square feet, a soiled workroom for the exclusive use of the operating staff, a storage room, an out-patient change area, (which is required if out-patient surgery is to be provided,) a stretcher alcove and a storage area for portable x-ray equipment as required under Rule 10D-28.081(10)(d) and (e). ICU/CCU - The ICU area was only generally laid out on the plans and there was no indication where the isolation room, emergency cardio-pulmonary resuscitation cart storage, soiled utility room, clean linen storage, equipment storage, staff toilets, staff lounge, waiting room, conference room, and nurses station would be located within this unit. All of these functions are required by Rule 10D-28.081(6). The ICU area functions cannot be shared with the general medical/surgical and nurses stations. The proposed ICU area does not appear to be large enough to accommodate the proposed ten ICU beds. This lack of space exists whether the rooms are arranged in a corridor or suite arrangement. The area where the ICU is proposed to be located has only one means of exit/access. Therefore, the ICU units will have to be set up in corridor system rather than a suite arrangement. Such an arrangement will reduce the usable square footage by approximately 800 feet. The loss of this 800 square feet further exacerbates the problem of lack of area. Nursing Care Unit - The nursing care unit shown on the plans does not have enough area to include all of the required functions set forth in Rule 10D- 28.081(5). Among the functions required to be located in the nursing care unit are a medication room of at least 50 square feet, a workroom and a storage room of at least 60 square feet, an equipment storage room and an alcove for stretchers. The plans submitted by Suburban failed to appropriately represent that the proposed project would meet the minimum standards set forth in Chapter 10D-28, Florida Administrative Code. While Suburban contends that the plans were not intended to be final and many of the issues could be addressed with HRS during the licensure process, the extent of the deficiencies raises serious questions as to whether this project could be completed within the budget set forth in the Application. A major redesign of the project will be necessary in order for it to meet code requirements. Suburban's contentions that these modifications could be made within the existing budget (including contingencies) and/or that waivers of certain elements could be obtained during the licensure process were not supported by persuasive evidence. Section 381.705(1)(n) requires a consideration of the applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent. As indicated above, no competent evidence was presented to establish the reasonableness of the patient mix set forth in the Application. Since Suburban has not begun operations, it has no historical record regarding provision of services to Medicaid and indigent patients. Dr. Minkes testified that the existing Outpatient Center treats all patients regardless of ability to pay and that the proposed project will operate on a similar basis. The existing Outpatient Center has entered into a contract with the State of Florida to provide primary care to Medicaid patients on a prepaid basis. Dr. Minkes anticipates that the proposed project would be used to provide hospital care to a large portion of the patients who enroll in the program. If that contract is implemented, the proposed project should provide some increased access for Medicaid patients. Section 381.705(2)(a) requires a consideration of the availability of less costly, more efficient or more appropriate alternatives to the proposal. Alternatives to new construction include purchasing an existing acute care hospital, working in conjunction with an existing acute care hospital in a joint venture or shared facility arrangement or increasing the utilization of Westchester. All of these alternatives could further the osteopathic presence in the District and Subdistrict without the need for additional construction and the addition of new acute care beds. While Dr. Minkes indicated that he did not feel any of these alternatives were viable, it does not appear that any serious efforts were undertaken to explore these alternatives. Section 381.705(2)(b) requires a consideration of the utilization of existing facilities providing inpatient service similar to those proposed. As set forth in Findings of Fact 14 through 19 above, Westchester, which is located in the same subdistrict as the proposed facility, has been operating at approximately 27% occupancy. This occupancy level has been steadily decreasing for several years. It must be anticipated that the approval of this Application would further deteriorate the efficient use of Westchester. For purposes of this Section, HRS interprets "similar services" to osteopathic acute care bed applications to include allopathic facilities which provide osteopathic services within the service area. If this interpretation is accepted, it is clear that there is a great excess of acute care beds in the District and the addition of the proposed beds would only diminish the potential for their efficient use of the existing beds. Section 381.705(2)(d) requires a consideration of whether patients will experience problems in obtaining inpatient care of the type proposed in the absence of the proposed new service. While there are only one hundred licensed osteopathic beds in the District, the evidence did not indicate that any individuals seeking osteopathic care were being denied such services. Section 381.705(2)(c) Florida Statutes, requires that, in the case of new construction, alternatives to new construction such as modernization or sharing arrangements, be considered and implemented to the maximum extent possible. As set forth in Findings of Fact 41 and 104 above, the evidence did not indicate that the modernization of Westchester or shared arrangements with other facilities have been fully explored. Baptist and South Miami are general acute care hospitals located in South Dade County. The primary service area for the proposed project overlaps the primary service areas of Baptist and South Miami. The evidence indicated that both intervenors are likely to loose some admissions and will probably experience some difficulties in obtaining skilled staff if this Application is approved. Both of the intervenor hospitals have a substantial number of vacant positions for which Suburban would be competing. If the Application is approved, Suburban will be seeking to fill its skilled staff positions from an already limited pool. One expected result would be an increase in salary structure for both Baptist and South Miami. Petitioner challenged the accuracy of the zip code analysis prepared by Mr. Cushman which attempted to estimate the number of lost admissions that each of the Intervenors could expect. While the zip code analysis does have many flaws, the evidence was sufficient to establish that both South Miami and Baptist will loose some admissions if the proposed facility is opened. Established programs at Baptist and South Miami could be substantially affected by the increase in salaries and lost admissions that are likely to occur if the proposal project is approved.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby, recommended that HRS enter a final order denying Suburban Medical Hospital, Inc.'s application for Certificate of Need #5868 to convert an existing outpatient surgery center to an osteopathic acute care hospital by conversion and new construction. RECOMMENDED in Tallahassee, Leon County, Florida, this 22nd day of March, 1991. J. STEPHEN MENTON 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 22nd day of March, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 89-4445 All four parties have submitted Proposed Recommended Orders. The following constitutes my rulings on the proposed findings of fact submitted by the parties. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. 1.-2. Adopted in substance in the Preliminary Statement. Adopted in substance in Findings of Fact 1 and 3. Adopted in substance in Findings of Fact 5. Adopted in substance in Findings of Fact 4 and 10. Adopted in pertinent part in Findings of Fact 8 and 10. Adopted in pertinent part in Findings of Fact 8 and 9. Adopted in substance in Findings of Fact 14 and 15. Adopted in substance in Findings of Fact 48. Subordinate to Findings of Fact 50-58. Subordinate to Findings of Fact 59. 12. Subordinate to Findings of Fact 63 and 64. 13. Subordinate to Findings of Fact 52 and 53. 14. Subordinate to Findings of Fact 61 and 62. 15. Subordinate to Findings of Fact 63 and 64. 16. Subordinate to Findings of Fact 65. 17. Subordinate to Findings of Fact 66. 18. Subordinate to Findings of Fact 67. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 58. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 53 and 56. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 55 and 65. Subordinate to Findings of Fact 69, 33 and 34. Rejected as a summary of testimony rather than a finding of fact. Subordinate to Findings of Fact 68. Adopted in substance in Findings of Fact 44 and in the Preliminary Statement. 26. Subordinate to Findings of Fact 37-42. 27. Subordinate to Findings of Fact 37 and 42. 28. Subordinate to Findings of Fact 37. 29. Subordinate to Findings of Fact 26. 30. Subordinate to Findings of Fact 27. 31. Subordinate to Findings of Fact 24-30. 32. Subordinate to Findings of Fact 24. 33. Subordinate to Findings of Fact 24 and 28. Rejected as vague, overbroad and irrelevant. Subordinate to Findings of Fact 26 and 30. Adopted in substance in Findings of Fact 15. Rejected as constituting a summary of testimony rather than a finding of fact because it is irrelevant to the conclusions reached in the Recommended Order. Subordinate to Findings of Fact 21-23. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 21-23. Rejected as constituting a summary of testimony and legal argument rather than a finding of fact. This subject area is addressed in Findings of Fact 41, 70, 94 and 106. Subordinate to Findings of Fact 73. Adopted in substance in Findings of Fact 73. Subordinate to Findings of Fact 74. Subordinate to Findings of Fact 75. Subordinate to Findings of Fact 75. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 75. Subordinate to Findings of Fact 79-81 and 90. Rejected as irrelevant. This subject matter is addressed in Findings of Fact 76. Subordinate to Findings of Fact 76. Subordinate to Findings of Fact 81 and 82. Rejected as unnecessary and irrelevant. Subordinate to Findings of Fact 13 and 83. Rejected as constituting a summary of testimony and legal argument rather than a finding of fact. This subject matter is addressed in Findings of Fact 41, 104 and 108. Subordinate to Findings of Fact 85. Subordinate to Findings of Fact 82. Subordinate to Findings of Fact 86-93. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 69 and 93. Subordinate to Findings of Fact 69 and 93. Subordinate to Findings of Fact 69 and 93. Subordinate to Findings of Fact 69 and 93. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 69 and 93. Rejected as constituting a summary of testimony and argument rather than a finding of fact. This subject matter is addressed in Findings of Fact 69 and 73. Subordinate to Findings of Fact 80 and 89. Subordinate to Findings of Fact 80. Subordinate to Findings of Fact 86 and 87. Subordinate to Findings of Fact 86-93. Subordinate to Findings of Fact 86-92. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 93 and 98-100. Rejected as constituting a summary of testimony and legal argument rather than a finding of fact. This subject matter is addressed in Finding of Fact 86 and 87. 70-72. Subordinate to Findings of Fact 94 and 105. 70.(sic) Rejected as unnecessary. A related issue is addressed in Findings of Fact 94. Adopted in substance in Findings of Fact 95. Subordinate to Findings of Fact 100. Subordinate to Findings of Fact 100. Rejected as unnecessary. Subordinate to Findings of Fact 90. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 96-101. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 96-101. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 100. Subordinate to Findings of Fact 102. Subordinate to Findings of Fact 103. Subordinate to Findings of Fact 104. See the rulings on proposed findings 29-40 above. Subordinate to Findings of Fact 108. Subordinate to Findings of Fact 26 and 27. Subordinate to Findings of Fact 31. Suburban has submitted eleven proposed findings with respect to the standing issue. Those proposals are subordinate to Findings of Fact 109-112. The Respondent's Proposed Findings of Fact Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. 1. Adopted in substance in Findings of Fact 5. 2.-3. Adopted in substance in Findings of Fact 1. 4. Adopted in substance in Findings of Fact 5. 5.-6. Subordinate to Findings of Fact 7. 7.-8. Adopted in substance in Findings of Fact 36 and 42. Addressed in Findings of Fact 36, 42, 43 and 71. Adopted in substance in Findings of Fact 42. Adopted in substance in Findings of Fact 40. Adopted in substance in Findings of Fact 14. Adopted in substance in Findings of Fact 21. Adopted in substance in Findings of Fact 15 and 21. Subordinate to Findings of Fact 43. Subordinate to Findings of Fact 71. Adopted in substance in Findings of Fact 33. Adopted in substance in Findings of Fact 24 and 25. Rejected as unnecessary. Rejected as unnecessary. Adopted in substance in Findings of Fact 41-43 and 71. Adopted in substance in Findings of Fact 42. Adopted in substance in Findings of Fact 72. 24.-25. Adopted in pertinent part in Findings of Fact 21. Adopted in substance in Findings of Fact 20 and 21. Adopted in substance in Findings of Fact 20. 28. Subordinate to Findings of Fact 40. 29. Subordinate 106. to Findings of Fact 105 and 30. Subordinate 49. to Findings of Fact 46 and 31. Subordinate 49. to Findings of Fact 46 and Adopted in substance in Findings of Fact 50. Subordinate to Findings of Fact 51. Subordinate to Findings of Fact 59. Subordinate to Findings of Fact 53. Subordinate to Findings of Fact 53. Subordinate to Findings of Fact 53 and 55. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 8, 10 and 56. 39. Subordinate to Findings of Fact 58. 40. Subordinate to Findings of Fact 62. Subordinate Subordinate to Findings of to Findings of Fact Fact 57. 53 and 57. 43. Subordinate to Findings of Fact 55. 44. Subordinate to Findings of Fact 53-55. 45. Subordinate to Findings of Fact 54. 46. Subordinate to Findings of Fact 65. Subordinate Subordinate to Findings of to Findings of Fact Fact 65. 63 and 66. Subordinate Subordinate to Findings of to Findings of Fact Fact 64 and 64. 66. Subordinate to Findings of Fact 55 and 64. Subordinate to Findings of Fact 67. Adopted in pertinent part in Findings of Fact 53. 54. Subordinate to Findings of Fact 85-93. 55. Subordinate to Findings of Fact 85-93. 56. Subordinate to Findings of Fact 86 and 87. 57. Subordinate to Findings of Fact 87. 58. Subordinate to Findings of Fact 86 and 87. 59. Subordinate to Findings of Fact 87. 60. Subordinate to Findings of Fact 87. 61. Subordinate to Findings of Fact 87. Addressed in pertinent part in Findings of Fact 86. This subject matter is also addressed in the Preliminary Statement and the Conclusions of Law. Subordinate to Findings of Fact 86 and 87. This subject is also addressed in paragraphs 17 of the Conclusions of Law. Addressed in paragraphs 17 of the Conclusions of Law. Addressed in pertinent part in Findings of Fact 65. 66. Subordinate to Findings of Fact 82. 67. Subordinate to Findings of Fact 81. 68. Subordinate to Findings of Fact 81. 69. Subordinate to Findings of Fact 81. 70. Subordinate to Findings of Fact 78 and 81. 71. Subordinate to Findings of Fact 86-93. 72. Subordinate to Findings of Fact 86-93. 73.-74. Addressed in pertinent part in Findings of Fact 86 and 88. Addressed in the Preliminary Statement. Adopted in substance in Findings of Fact 96. Adopted in substance in Findings of Fact 96. Adopted in substance in Findings of Fact 96. Adopted in substance in Findings of Fact 101. 80.-101. Adopted in substance in Findings of Fact 101. Subordinate to Findings of Fact 100 and 102. Subordinate to Findings of Fact 98, 100 and 102. Rejected as a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 71. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 20. Subordinate to Findings of Fact 42, 43 and 107. Adopted in substance in Findings of Fact 107. Subordinate to Findings of Fact 31, 33, 42, 43 and 70-73. Adopted in substance in Findings of Fact 20 and 21. Adopted in substance in Findings of Fact 70 and 106. 111. Subordinate 101. to Findings of Fact 73 and 97- 112. Subordinate and 108. to Findings of Fact 45, 104 113. Subordinate and 108. to Findings of Fact 45, 104 Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 45, 104 and 108. Rejected as unnecessary. Furthermore, there is considerable confusion as to how this per diem calculation was made. 116.-117. Subordinate to Findings of Fact 105-106. The Intervenor's Proposed Findings of Fact (Baptist Hospital) Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. 1.-7. Subordinate to Findings of Fact 109-112. This subject matter is addressed in paragraph 2 of the Conclusions of Law. 8.-14. Subordinate to Findings of Fact 50-67. Subordinate to Findings of Fact 15 and 17- 23. Adopted in pertinent part in Findings of Fact 17, 21, 30, 65 and 69. This proposal consists largely of legal argument and is addressed in the Conclusions of Law. Pertinent portions of the proposal are addressed in Findings of Fact 14 and 18. Subordinate 37. to Findings of Fact 42. 19. Subordinate and 108. to Findings of Fact 41, 104 20. Subordinate to Findings of Fact 71 and 83. 21. Subordinate 71-73. to Findings of Fact 24-33 and 22. Subordinate to Findings of Fact 71. 23. Subordinate 71-73. to Findings of Fact 37-43 and 24. Subordinate 72. to Findings of Fact 20, 42 and 25. Much of this proposal consists of legal argument. The pertinent factual provisions are addressed in Findings of Fact 70 and 106. 26. Subordinate to Findings of Fact 106. 42 and 27. Subordinate to Findings of Fact 105. 42 and 28.-29. The pertinent portions of these proposals are addressed in Findings of Fact 73. The remainder of these proposals are rejected as irrelevant. Subordinate to Findings of Fact 71. Adopted in pertinent part in Findings of Fact 14 and 75. 32. Subordinate to Findings of Fact 76. 33. Subordinate to Findings of Fact 77. 34. Subordinate to Findings of Fact 78-81. 35. Subordinate to Findings of Fact 75. 36. Subordinate and 108. to Findings of Fact 41, 104 37. Subordinate 103. to Findings of Fact 83 and 38. Subordinate 85. to Findings of Fact 76-82 and 39. Subordinate to Findings of Fact 85-102. 40. Subordinate 93. to Findings of Fact 86-88 and 41. Subordinate to Findings of Fact 86-102. 42. Subordinate to Findings of Fact 94. This proposal consists largely of legal argument. Pertinent factual issues are addressed in Findings of Fact 20 and 21, 76 and 94. Subordinate to Findings of Fact 95-102. Subordinate to Findings of Fact 83 and 103. Much of this proposal consists of legal argument and/or speculation. Pertinent factual issues are addressed in Findings of Fact 41, 104 and 108. Subordinate to Findings of Fact 105 and 106. Subordinate to Findings of Fact 41, 104 and 108. Subordinate to Findings of Fact 69. The Intervenor's Proposed Findings of Fact (South Miami Hospital) Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Adopted in substance in Findings of Fact 4. Adopted in substance in Findings of Fact 5. Adopted in substance in Findings of Fact 6. 4.-6. Subordinate to Findings of Fact 16-19. Adopted in substance in Findings of Fact 15, 20 and 21. The first sentence is adopted in substance in Findings of Fact 48. The remainder is rejected as constituting legal argument. Adopted in pertinent part in Findings of Fact 49 and 50. Adopted in substance in Findings of Fact 6. Subordinate to Findings of Fact 7. Subordinate to Findings of Fact 101. Adopted in substance in Findings of Fact 79. Adopted in substance in Findings of Fact 2. Adopted in pertinent part in Findings of Fact 101. Subordinate to Findings of Fact 100. Included in the Preliminary Statement. Subordinate to Findings of Fact 73. Adopted in pertinent part in Findings of Fact 96. Adopted in substance in Findings of Fact 101. Subordinate to Findings of Fact 101. Subordinate to Findings of Fact 98-100. Subordinate to Findings of Fact 100 and 102. Rejected as constituting a summary of testimony rather than a finding of fact. This subject matter is addressed in Findings of Fact 98-102. Adopted in substance in Findings of Fact 44 and in the Preliminary Statement. Adopted in substance in Findings of Fact 44 and 45. Adopted in substance in Findings of Fact 45. Adopted in pertinent part in Findings of Fact 48 and 49. Rejected as irrelevant. Subordinate to Findings of Fact 70 and 106. Adopted in pertinent part in Findings of Fact 20 and 21. Rejected as vague. This subject matter is addressed in Findings of Fact 20 and 21. Subordinate to Findings of Fact 33 and 35. Subordinate to Findings of Fact 20, 21 and 42. Subordinate to Findings of Fact 23 and 30. Adopted in substance in Findings of 25. Subordinate to Findings of Fact 24. Subordinate to Findings of Fact 24 and 30. Subordinate to Findings of Fact 23. Subordinate to Findings of Fact 23. Addressed in pertinent part in Findings of Fact 20 and 21. 42.-43. Rejected as overly broad. This subject matter is addressed in Findings of Fact 31. 44. Subordinate to Findings of Fact 40 and 42. 45. Subordinate to Findings of Fact 73. 46. Subordinate to Findings of Fact 35. 47.-51. Subordinate to Findings of Fact 49-67. 52. Subordinate to Findings of Fact 35. 53.-55. Subordinate to Findings of Fact 109-112. 56. Subordinate to Findings of Fact 85-93. 57. Subordinate to Findings of Fact 69. 58. Subordinate to Findings of Fact 69 and 93. Rejected as overly broad. This subject matter is addressed in Findings of Fact 35 and 73-109. Rejected as unnecessary. COPIES FURNISHED: Daniel C. Minkes, Esquire 17615 S.W. 97th Avenue Miami, Florida 33157 Silvio Amico, Esquire 6401 S.W. 87th Avenue Suite 114 Miami, Florida 33173 Thomas R. Cooper, Esquire Edward Labrador, Esquire Suite 103 2727 Mahan Drive Tallahassee, Florida 32308 Kyle Saxon, Esquire Catlin, Saxon, Tuttle & Evans 1700 Alfred I. Dupont Building 169 East Flagler Street Miami, Florida 33131 Jay Adams, Esquire 1519 Big Sky Way Tallahassee, Florida 32301 Jean Laramore, Esquire 7007 McBride Pointe Tallahassee, Florida 32312 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Linda K. Harris Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue The issue in this proceeding is whether the Respondent, Jules Jonas Dossick, D.O. violated statutes governing the practice of osteopathic medicine on the grounds alleged in the administrative complaint and if so, what disciplinary action is appropriate. Background and Procedural Matters This proceeding commenced when Petitioner filed its administrative complaint and Respondent timely requested a formal hearing. At the hearing Petitioner verbally amended its complaint by deleting all factual and legal allegations relating to sexual misconduct and violations of Section 459.015(1)(k) Florida Statutes. Petitioner presented evidence through three witnesses and four exhibits. Respondent testified on his own behalf and presented one exhibit. All exhibits were admitted without objection. Petitioner has submitted a proposed recommended order, which proposal has been considered and, in part, included in this order. A specific ruling on each proposed finding of fact is found in the appendix attached hereto. By pleadings dated May 23, 1986, Respondent has moved for a re- hearing and has objected to the Petitioner's proposed recommended order, both on the grounds that he has now retained counsel and should have the opportunity to have the case re-heard with the benefit of an attorney. Respondent had an attorney in an earlier part of this proceeding and discharged him by letter dated February 22, 1986. (see letter attached to motion to withdraw filed March 3, 1986). Approximately two months later the final hearing was held. Respondent had ample time to retain new counsel or ask for a continuance. He proceeded to hearing, aware of his rights and without protest. The record is void of any basis to consider such extraordinary relief.
Findings Of Fact Respondent, Dr. Dossick, is now and at all times relevant has been licensed as an osteopathic physician in Florida under license number OS 0000874. He practices at his clinic, North Miami Medical Center, located at 4805 East 4th Avenue in Hialeah, Florida. (T-10,11). The clinic is comprised of a reception room, a kitchen that is also used as an office, a bathroom near the reception area, a supply room, two examining rooms, and two additional rooms with a bathroom and shower at the rear of the clinic. Dr. Dossick lives at the clinic and keeps the additional rooms for his bedroom, for storage and for personal use. One of the additional rooms was used several years ago as a third examining room. (T-43, 44, 114-116). In January 1985, two investigators from the Department of Professional Regulation went to Respondent's Clinic for an inspection. They took pictures and spoke to Dr. Dossick. Three other individuals were at the clinic the day of the inspection: a man and woman in one examining room, and a woman in what the inspectors thought was an examining room, but was identified by Dr. Dossick as his personal use and storage room. (T-41, 49, 57, 64, 116). The investigators found the clinic in varying stages of filth and disarray. The reception room was old and worn, unclean, but with little sign of current use. The kitchen had dirty dishes and exposed garbage. The examining rooms were fairly neat but the medications on the countertops were old, dirty and, in some cases, expired. There was no garbage in the two examining rooms, but they did not appear clean. The third room, the former examining room (now used for storage and Dr. Dossick's personal living quarters) was a mess: clothing, mail and fast food containers were strewn about, cotton swabs were exposed and piled on a counter; syringes and medications were also exposed on the countertops. In this room the narcotics supply was stored in a locked cabinet. Two dogs were present in the clinic, one of which had patches of hair missing as if diseased. (T-46, 49, Petitioner's Exhibits #3 and #4) There was no evidence that patients had access to the kitchen, supply room or Dr. Dossick's bedroom. Patients occasionally go to the former examining room and wait there prior to seeing the doctor. Dr. Dossick keeps his own dog at the clinic and, even though he does not encourage them, his patients sometimes bring their animals to the clinic with them. Dr. Dossick admitted that he had trouble for a while keeping the place clean. The woman who worked for him injured her knee in a karate tournament and had surgery. While the admission of problems was candid, the excuse regarding the former cleaning worker was confused: the handwritten statement Dr. Dossick presented from Barbara O'Rourke suggested that her accident and subsequent surgery occurred in April and July 1 85, respectively; that is, several months after the DPR inspectors' visit. (T-64, 87-89, 105-106, 112-113). Linda Joyce Godfrey is a patient of Dr. Dossick. She is thirty-nine years old, was born with cerebral palsy, and around 1981 was diagnosed with multiple-sclerosis. She is crippled and walks unaided with considerable difficulty. She has undergone several operations and lengthy periods of hospitalization. She has been under the care of various physicians, including an orthopedist, several neurosurgeons, and another osteopathic physician. (T-66, 69) Ms. Godfrey began seeing Dr. Dossick after an extended hospitalization period. She picked him at random and asked for percodan, a controlled narcotic substance, generally prescribed for pain relief. He refused to give her the percodan and prescribed a non-narcotic medication instead. She continued seeing him and later he prescribed placidyl, percocet and percodan at various times to help her sleep and for the severe pain in her muscles and bones. He did not give her these medications until he obtained her hospital reports and talked with her regular physicians. (T-66,69,81) Ms. Godfrey admits that she was an addict. She claims that Dr. Dossick was initially unaware of this but later helped her get off the habit. On one occasion she went to his office in the state of apparent overdose. He called Hialeah Fire and Rescue and got her out of there. He told her not to come around anymore because he didn't go for drugs. She later went back and asked for help. The evidence is inconclusive as to whether Ms. Godfrey's episode was an overdose or a grand mal seizure. (T-69, 73-76, 80, 90-91). According to Ms. Godfrey, Dr. Dossick injected her with Demerol on only one occasion, around six weeks prior to the hearing, after her apartment was broken into and she was raped. (T-71, 72). The practice of osteopathic medicine encompasses all aspects of medicine commonly referred to as allopathic medicine, but also includes physiotherapy, manipulative therapy, nutrition: a holistic approach. (T-13,14). This characterization of the distinction between the professions is borne out in the statutory definitions of "practice of medicine" and "practice of osteopathic medicine": "Practice of osteopathic medicine" means the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition, which practice is based in part upon educational standards and requirements which emphasize the importance of the musculoskeletal structure and manipulative therapy in the maintenance and restoration of health. 1l. Except for the underlined verbiage the two definitions are the same. See Section 458.305(3) Florida Statutes, and Section 459.003(3) Florida Statutes. One of the rudiments of osteopathic medicine values the "laying of hands" as part of caring for a patient in a very kind and personal manner. Cleanliness of the person and the physical area surrounding the practitioner is essential to avoid transferring disease from one patient to another. (T-18,19) Animals should not be present in the clinic because of the potential for communicating disease to humans through fleas, flies or the animals. (T-18) Old, dirty drugs and syringes should be disposed of in such a manner as to avoid access and use. (T-19,20) The above standards were described in the competent, uncontroverted testimony of Petitioner's expert, Ralph Birzon, D.O. Those standards were violated by Dr. Dossick when he allowed dogs in the clinic, when he failed to properly dispose of old drugs and syringes, and when he failed to keep his clinic clean. Dr. Dossick does, however, treat his patients in a very kind and personal manner. Ms. Godfrey was called as Petitioner's witness. Her testimony was credible and touchingly candid, as also was Dr. Dossick's. Ms. Godfrey said Dr. Dossick helped her; he took pity on her; he is good to his patients and is a good man. She does not have the money to pay for his treatment or the prescriptions, so she sometimes files and answers the phone at the clinic. Dr. Dossick is the oldest physician in the area; he spends a lot of time with his patients and they depend on him. He regularly treats his patients without charge, or for a token fee. He also loans them money for prescriptions. He has treated some patients for 25-30 years. (T-81, 83, 93, 95-96, 103) Dr. Dossick has previously been suspended by the Board of Osteopathic Medical Examiners for six months because of allegations that he prescribed medication without performing an examination. He volunteered this fact. (T-97, 107-109) The violations occurred approximately ten years ago. See Board of Osteopathic Medical Examiners v Dossick DOAH #76-1814; Dossick v Florida State Board of Osteopathic Medical Examiners, 359 So. 2d 12 (Fla. 3rd DCA 1978). The clinic has been cleaned up since the investigators' visit and the dirty and outdated drugs have been discarded. (T- 88,104)
Findings Of Fact The following Findings of Fact are based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding. Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to section 20.43, and chapters 456 and 459, Florida Statutes. At all times material to these proceedings, Respondent was a licensed osteopathic physician within the State of Florida, having been issued license number OS 8729. Respondent's address of record at the time of filing the Administrative Complaint was 11950 County Road 101, Suites 101, 102, and 103, The Villages, Florida 32162. Respondent's current address of record is 13767 U.S. Highway 441, Lady Lake, Florida 32159. Respondent currently holds no board certification in any specialty area, and did not complete any residency other than in emergency medicine. Respondent attended Michigan State University, College of Osteopathic Medicine. In 2002, he began full-time practice as an emergency room physician at Munroe Regional Medical Center in Ocala, Florida. He worked as an emergency room physician until he opened Exceptional Urgent Care Center (“EUCC”). At all times material to this complaint, Respondent owned and operated EUCC. Treatment Provided to Patient J.K. On March 15, 2018, J.K., along with his wife, presented to EUCC with complaints of a sore throat and fever. This was the first of two visits to the clinic. J.K. reported his medications as Amlodipine, Warfarin, Tamsulosin, and Dofetilide (unless otherwise indicated, hereinafter referred to by its trade name "Tikosyn"). J.K. was prescribed these medications by his cardiologist at the William S. Middleton Memorial Veterans Hospital (“V.A. Hospital”) in Wisconsin, his home state. Relevant to this matter, Tikosyn helps patients maintain a normal heartbeat rhythm. Tikosyn was prescribed to keep J.K.'s heart in rhythm as he had atrial fibrillation. J.K. was treated by a nurse practitioner, who ordered a chest x-ray and a flu swab. The flu swab returned negative, and the chest x-ray showed no focal pneumonia. J.K. was prescribed Tamiflu and Naproxen. J.K. elected not to fill the Tamiflu due to the “expensive cost.” Respondent was not involved in J.K.'s treatment on this date. On March 16, 2018, J.K. and his wife K.K. returned to EUCC as J.K.’s symptoms had not improved. On this visit, J.K. saw Dr. Im. Dr. Im evaluated J.K. and ordered two tests. Dr. Im ordered a Prothrombin Time International Normalized Ration ("PT INR") test to determine J.K.'s coagulation and he ordered a CT scan of the chest. The PT INR results were within the therapeutic range. The CT scan showed shattered ground- glass opacification in the posterior right lower lobe and the medial left upper lobe. The CT scan findings were interpreted as "non-specific, may represent hypoventilatory change or an infectious inflammatory process (acute or chronic).” Respondent advised J.K. and K.K. that the CT scan appeared to show the start of pneumonia, and he was going to prescribe three medications: Levaquin 750 mg, Prednisone 20 mg, and Zyrtec 10 mg. K.K. testified that she asked Respondent if the Levaquin, Prednisone, or Zyrtec were contraindicated with any of J.K.'s current prescriptions, specifically Tikosyn. K.K recalls that Respondent replied that he was not familiar with Dofetilide (Tikosyn), and advised them to check with the pharmacist to see if there were any contraindications. Although Respondent initially advised J.K. and K.K. that he was not familiar with Tikosyn, Respondent testified that he advised J.K. and K.K. of the possible interactions between Levaquin and Tikosyn and told her that the interaction was very rare. He testified that he advised J.K. and K.K. that the pharmacist is a safety net, and the pharmacist would call him to discuss the prescriptions if he missed anything. K.K. credibly testified that Respondent did not counsel J.K. or K.K. on any risks regarding the medications Dr. Im prescribed or provide them with any alternatives during the visit on March 16, 2018. J.K. and K.K. left EUCC and went to Publix to fill the prescriptions. K.K. asked the pharmacist if any medications would interfere with any of J.K.'s prescribed medications. Upon advice of the pharmacist that Levaquin was contraindicated with Tikosyn, K.K. declined to fill the prescription for Levaquin. On behalf of J.K., K.K. then called EUCC and asked for a different antibiotic that would not interact with Tikosyn. However, she was instructed to contact J.K.'s cardiologist. K.K. then contacted the cardiology staff of the V.A. Hospital in Wisconsin, who instructed K.K. to follow the advice of the pharmacist and (tell J.K.) not to take the Levaquin. K.K. called EUCC a second time to confirm whether J.K. had an infection and she was told that J.K. did not have an infection. Respondent recalls that he had a personal conversation with K.K. during a courtesy telephone call placed the next day (March 17, 2018). Respondent testified that during that call, he explained Levaquin was the drug of choice, other medications would not cover J.K.'s pneumonia, the potential interactions were very rare, and J.K. needed to take the Levaquin. By his own admission and his medical records, Respondent did not provide J.K. or K.K. with any specific alternative antibiotics and insisted that J.K. needed to take the Levaquin. K.K. disputes that Dr. Im spoke with her or J.K. at any point after the March 16, 2018, visit. She clearly recalled that she spoke with a woman each time she spoke with staff at Dr. Im’s office. Overall, J.K. and K.K. clearly and convincingly testified that Respondent never advised them of the risks of using Levaquin with Tikosyn or provided any alternatives to the Levaquin. Expert Testimony Petitioner offered the testimony of Dr. Anthony Davis, who testified as an expert. Dr. Davis has been licensed as an osteopathic physician in Florida since 1995. Dr. Davis attended Kirksville College of Osteopathic Medicine and completed an internship in family practice. He has been board certified in family medicine by the American Board of Osteopathic Family Physicians since 2001, and board certified in emergency medicine by the American Association of Physician Specialists since July 2003. He is also affiliated with professional organizations including the American College of Family Practice and Florida Osteopathic Medical Association. Dr. Davis was accepted as an expert in emergency and family medicine. Dr. Davis relied upon his work experience, his training, and his review of the medical records for J.K. to render his opinion regarding the standard of care related to treating J.K. The standard of care requires an osteopathic physician treating a patient similar to J.K. to: (1) provide and document their justification for why Levaquin was the appropriate drug of choice; (2) note the patient’s acknowledgment that there are interactions with Tikosyn; (3) ensure the patient understands the risks and benefits of combining Tikosyn and Levaquin; (4) explain to the patient that there are limited alternatives to Levaquin; and (5) provide the reason for prescribing a potentially dangerous drug. Levaquin is a medication that comes with a black box warning that requires physicians to counsel patients on the risks associated. When a drug is designated as contraindicated and has a category X for interaction, the standard of care requires that the physician clearly explains to the patient why they are using the drug and defend how it is going to be safe. Tr., p. 70. Dr. Davis opined there were multiple treatment options available for J.K., such as supportive care or an antibiotic with a lower risk of interaction with J.K.'s existing medication. Moreover, Dr. Davis testified that there were safer alternatives to Levaquin that would effectively treat pneumonia, such as doxycycline, if J.K. actually had pneumonia and an antibiotic was necessary. Respondent provided literature from the Infectious Diseases Society of America related to community-acquired pneumonia in an attempt to prove that X-Ray or other imaging techniques are required for the diagnosis of pneumonia and to support his claim that Levaquin was the drug of choice for J.K. However, Dr. Davis credibly pointed out that the article, published in 2007, is no longer accurate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medicine enter a Final Order as follows: Finding that John Joseph Im, D.O., violated section 459.015(1)(x), by committing medical malpractice, as defined in section 456.50, as alleged in the Administrative Complaint; Issue a letter of concern against Respondent’s license to practice osteopathic medicine; Requiring completion of a prescribing practices course; and Imposing an administrative fine of $2,500. DONE AND ENTERED this 16th day of December, 2019, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN 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 16th day of December, 2019.
Findings Of Fact At all times relevant hereto Lawrence D. Urban was a licensed osteopathic physician in Florida having been issued license number OS 001232. From January 1983 through at least March 17, 1984, Respondent maintained offices in Clearwater and Zephyrhills. He practiced in the Clearwater office on Monday, Wednesday and Friday of each week and in the Zephyrhills office on Tuesday, Thursday and Saturday. Respondent employed Wendell Bloom to work in the Zephyrhills office as a business manager and assistant to Respondent. Bloom had no medically related license such as physician's assistant, nurse, technician, etc. As an assistant to Respondent, Bloom drew blood, performed vascular analyses, mixed IV solutions, and administered IV solutions. He worked at the Zephyrhills office Monday through Friday. Bloom had standing orders from Respondent that if a new patient came in Bloom would draw a blood sample, send it to the lab for analysis and make an appointment for the patient to see Respondent when the results of the blood analysis was received. Respondent described his practice in Zephyrhills as holistic, involving nutrition, chelation, and cancer therapy using laetril. Chelation treatment involves the intravenous injections of solutions containing EDTA (Ethylenadiaminetetracetic acid), vitamins, including B12, B complex and C, and the minerals, calcium and magnesium. On many occasions Bloom commenced IV chelation injections containing EDTA before Respondent arrived at the office and completed some of these after Respondent had left the office. On at least five (5) occasions Bloom injected patients with IV solutions containing EDTA without Respondent being present any time during the procedure. Drawing blood without a doctor present in the office constitutes the practice of medicine. Injecting IV solutions in patients constitutes the practice of medicine without a doctor present. In the Zephyrhills office Respondent referred to Bloom as Dr. Bloom in the presence of patients. No sign or disclaimer was posted in the office that Bloom had no prior medical training and was not licensed in any medically related health professional field in Florida. Respondent knew that patients might believe Bloom to be a medical doctor. In administering an IV solution to a patient there is always a danger of an allergic reaction or an anaphylactic reaction, even if a patient has previously tolerated the treatment. Respondent acknowledged that serious side affects would result to a patient receiving an IV solution containing EDTA if the patient suffered kidney failure. Bloom also operated the vascular analyzer machine in the office. As described by Bloom, by attaching clips from the machine to the fingers and toes the machine will tell you if there is any kind of clotting or obstruction any place within the cardiovascular system. Further, by putting transmission gel on the clip and holding it over an artery, transmissions from the clip with the return echo is transformed onto a chart which will denote the elasticity of the artery. This machine is not universally accepted in the medical profession. By Final Order entered August 26, 1983 (Exhibit 1) the Florida Board of Osteopathic Medical Examiners found Respondent guilty of filing false reports, fee splitting, and abetting an unlicensed person to practice osteopathic medicine. He was sentenced to a reprimand, placed on probation for six (6) months and directed to report to the Board at the end of the probationary period. If, at this time, Respondent's report on the status of his practice satisfies the Board that the financial aspects of his practice is in accordance with the law, the reprimand will be withdrawn. Terms and conditions of the probation were not delineated. Respondent appeared before the Board at its March 17, 1984 meeting. After Respondent reported that the financial aspects of his practice were poor, but in conformity with the law, one of the Board members inquired if Respondent was working with any non-osteopathic physicians in his practice, which was one of the accusations for which he was reprimanded and placed on probation. At this point Respondent told the Board that he had a helper who was a "non- anything" who was drawing blood, doing vascular analyses of patients, giving IVs to patients undergoing chelation therapy and whatever Respondent told him to do. (Exhibit 2) After hearing these disturbing facts the Board voted to extend the Respondent's probation while an investigation of his practice was conducted. The charges considered at this hearing were those resulting from that investigation.
Findings Of Fact Upon consideration of the oral and documentary evidence presented at the hearing, the following facts are found: At all times pertinent to this case, Respondent was licensed to practice osteopathic medicine in the State of Florida under license numbered 0003783. On April 1, 1981, the Florida Board of Osteopathic Medical Examiners (Board), through the Department of Professional Regulation (DPR), filed an Administrative Complaint against Respondent alleging several violations of Florida Statutes governing the practice of osteopathic medicine. In an effort to forestall an emergency suspension of her license as a result of these allegations, Respondent entered into a Stipulation with the Board whereby she agreed to cancel her certificate to prescribe Schedule II and III, Chapter 893, drugs; to remain enrolled in and comply with all terms of the Impaired Physicians Program; to submit blood and urine samples for drug screening upon request of DPR; and to obey all federal and state laws and regulations pertaining to the practice of osteopathic medicine. On June 10, 1982, the Board, after an informal hearing, entered an order finding that Respondent had violated the various provisions of the statutes as alleged and suspended her license for a period of six months. However, the Board considered and incorporated into its order the aforementioned Stipulation and stayed the suspension, placing Respondent on probation for three years. Sometime in January, 1983, the Secretary of DPR, being made aware of alleged violations of the terms of the probation, entered an order of emergency suspension of Respondent's license, alleging as reasons therefor: That on November 29, 1982, Respondent prescribed Demerol, a Schedule II controlled drug, for a patient, Ernestine Franklin; That on November 10, 1982, Respondent was found in an unconscious state at home. Taken to the hospital, when she regained consciousness, she was disoriented and incoherent; her speech was garbled, and she demonstrated erratic and violent behavior; That on or about December 7, 1982, Respondent prescribed Demerol for Maureen Lyewfong, the cost of which was charged to the Respondent; On December 17, 1982, an unidentified male brought Respondent to the hospital indicating she had snorted cocaine. She would not allow herself to be examined; That on December 24, 1982, Respondent was admitted to North Shore Hospital, Miami, claiming she had suffered an epileptic seizure. During the course of her workup, she indicated she was allergic to Demerol; and That by letter dated December 30, 1982, Dr. Morgan, head of the Impaired Physicians Program, informed DPR that Respondent had diverted for own use Demerol prescribed for her patients and that she had failed to keep appointments for treatment under the program. On January 18, 1983, sometime after the emergency suspension went into effect, the Board through the Department of Professional Regulation filed a seven-count Amended Administrative Complaint seeking to suspend, revoke, or otherwise discipline Respondent's license, listing as grounds for this action basically the same allegations as found in the emergency suspension order. On November 30, 1982, Respondent treated Ernestine Franklin for removal of a pilonidal cyst. Prior to the surgery, Respondent administered an injection of Demerol to the patient from a bottle for which she had written a prescription the previous day. This prescription had been filled at a pharmacy by Nurse Susan Dukes and charged to Respondent's account. When she brought the Demerol back to the office, Dukes placed it in the locked medicine cabinet and told Respondent where she had put it. When she went to set up for Ms. Franklin's surgery, the bottle of Demerol was not there. Dr. Krantz prepared the Demerol injection for the patient herself. The injection did not use up the entire amount on the prescription, and the unused portion was neither given to the patient nor seen in the office again. On December 7, 1982, Respondent wrote a prescription for Demerol for Maureen Lyewfong, the cost for which was charged to Dr. Krantz. Demerol is another name for meperidine hydrochloride, which is a Schedule II substance, as defined in Section 893.03(2)(b), Florida Statutes (1981). Respondent first entered the Impaired Physicians Program (IPP) under the supervision of Dr. Dolores Morgan in March, 1981,,because of her abuse of Demerol, Quaaludes, and cocaine. After a month in the hospital, she was released to an outpatient program which, because of her failure to progress properly, resulted in her going to the inpatient facility at Ridgeview, Georgia, where she spent several months. According to the terms of the IPP for Respondent, when she was discharged from the Ridgeview inpatient treatment center, she was to be in the program for two years. Since the IPP main office is in Miami and Respondent practices in West Palm Beach, she was placed under the supervision of a doctor in her area. From June, 1982, the date of the Stipulation, to December, 1982, Dr. Morgan heard nothing to indicate Respondent was not living up to the terms of the agreement. However, in December, 1982, Dr. Morgan was contacted by Dr. Joan Barice, local chairman of the IPP, who informed her that Dr. Krantz was missing required meetings of Narcotics Anonymous, as well as by the administrator of a local hospital, Mr. Steven Southerland, to the effect that Dr. Krantz was not performing properly. As a result, Dr. Morgan set up an appointment with Respondent for an interview on December 23, 1982, which Respondent did not keep. Another appointment was set up to discuss the matter, but before the date scheduled for the meeting, Dr. Morgan was advised Respondent was admitted to a hospital in Miami for drug detoxification. At this point, Dr. Morgan reported the latter to DPR. As will be seen in the succeeding paragraphs, this admission was not for drug detoxification, but for epileptic seizures. On December 17, 1982, at approximately 5:15 p.m., Respondent was taken by paramedics to the emergency room at Jupiter Hospital, Jupiter, Florida. At the time she was first seen by the paramedics, an empty vial of Demerol was found in her possession. When found, at her office, she was unconscious for five to ten minutes and, upon regaining consciousness, appeared drowsy. However, by the time she was seen by the emergency room nurse, Mr. Pollack, she appeared to be coherent. She indicated to him she was allergic to Demerol and had had a seizure earlier in the day because the level of Dilantin, a drug used to control epileptic seizures, in her blood was not high enough. In fact, on December 23, 1982, Respondent contacted Dr. Jack Kammerman, an internal medicine specialist on the staff at North Shore Hospital in Miami. She explained her symptoms, and Dr. Kammerman, who knew of Respondent's background through her mother, who had worked for him, suggested she immediately be hospitalized for tests. Dr. Krantz agreed, and the initial tests taken failed to reflect a reason for her seizures. A second CAT scan ruled out a tumor, so a neurologist was called in for consultation. This expert's initial and final diagnoses were "ideopathic epilepsy," the term "ideopathic" meaning "of unknown cause." At the time of admission, blood and urine samples were taken for use in tests. The first blood screen result showed traces of meperedine hydrochloride (Demerol) and Darvon, a pain reliever. A second screening of more blood taken from the same sample, but run later, reflected minute amounts of Demerol, which could indicate that the patient had taken the substance within the prior 72 hours. It was the pathologist's opinion that Demerol had been taken by Respondent. On the other hand, a false positive test result for Demerol in the blood is possible because many external factors, such as infection or the menstrual period (which Respondent was experiencing at the time), could affect it. I find, however, that based on the findings of the pathologist, an expert in his field, the substance in Respondent's blood was in fact Demerol. Respondent's seizures are now completely controlled through the use of the drugs Dilantin and phenobarbital. Dr. Kammerman is of the opinion that an osteopathic physician who suffers from controlled seizures can safely practice within the disciplines of family practice and internal medicine. Classically, seizure patients can predict the onset of a seizure due to the symptoms they experience before the seizure. Once the patient experiences the preseizure symptoms, he or she may prevent the seizure from occurring depending upon how fast the medicine can be gotten into the bloodstream in amounts sufficient to prevent it. Though Dr. Kammerman has never seen the Respondent go through a seizure and therefore does not know how she would react, he knows it is not uncommon for a patient who has just come out of the unconscious state of a seizure to be disoriented, confused, aggressive, and talkative, even to the extent of refusing help. Mr. Steven L. Southerland, Executive Director of Community Hospital of Palm Beach and one of the individuals who contacted Dr. Morgan regarding Respondent's aberrant behavior, knew her when she was on staff in the Department of Family Practice of that hospital. In the course of his official duties, information was brought to his attention that a patient admitted to the hospital by the Respondent was not seen by her afterwards for several days. This type of conduct was confirmed by Respondent's nurse, Ms. Dukes, who noticed a decided deterioration in Respondent evidenced by days of forgetfulness and confusion. On the other hand, two qualified osteopathic physicians who worked with Dr. Krantz on staff at Community Hospital and who have observed her in the practice of osteopathic medicine off and on for six or more years are satisfied that she is an extremely competent physician. She has assisted one, Dr. Michael A. Longo, in surgery, and he found her work to be excellent. He is aware of her epileptic-based seizures, and this does not change his high opinion of her competence. The other, Dr. Kirsch, who has also collaborated with her on the treatment of several patients, has never had the slightest problem with her, nor has he ever seen her in any way incapacitated.
Recommendation Based upon the Findings of Fact and Conclusions of Law rendered herein, it is RECOMMENDED THAT: The Respondent be found subject to disciplinary action for a violation of Subsections 459.015(1)(1), (q), (r), (s), and (t), Florida Statutes; The license of the Respondent, Dr. Barbara Anne Krantz, to practice osteopathic medicine in the State of Florida be revoked; The revocation be suspended for a period of three years and that she be limited to practice while under the supervision of a licensed osteopathic physician; and, with the further provision, The restrictions and limitations continue for such time and under such terms and conditions as the Board of Osteopathic Medical Examiners determines necessary to ensure protection of Respondent's patients and her ability to practice osteopathic medicine with reasonable skill and safety. RECOMMENDED this 2nd day of May, 1983, in Tallahassee, Florida. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings Department of Administration 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of May, 1983. COPIES FURNISHED: James H. Gillis, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William H. Pruitt, Esquire Pruitt & Pruitt 501 South Flagler Drive Suite 501 West Palm Beach, Florida 33401 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact At all times relevant hereto, Lawrence A. Decker was licensed as an osteopathic physician in Florida. On November 18, 1980, D. K. was admitted to Sun Coast Osteopathic Hospital, with an admitting diagnosis of acute generalized anxiety disorder, under the care of Dr. Kaye, a psychiatrist. On her initial examination, she complained of severe menstrual cramping. She was referred to an internist and a gynecologist (Respondent). Exhibit 1). At her gynecology examination, D. K. gave a history of pain in the right lower quadrant of her abdomen shortly following a tubal ligation some six years earlier. She had visited three gynecologists in the intervening years and had been treated with medication (Estrace, Valium and Progesterone) by one of these gynecologists without significant improvement in her symptoms; one suggested she had a prolapse, a hysterectomy was indicated and Tranxene was prescribed; and a third physician stated she had a sore muscle on her right ovary, but no therapy was suggested. Respondent suggested a hysterectomy might relieve the menstrual cramps, but was unlikely to improve her anxiety disorder unless that was brought on by the dysmenorrhea. D. K. talked to her husband and then told Respondent she would like to have the hysterectomy during her current admission rather than be discharged and return at a later date. After concluding D. K. was capable of consenting to the surgery, the hysterectomy was scheduled for November 24, 1980. In Dr. Joyes' hospital notes (Exhibit 1), an entry dated November 21, 1980 states in part: "Anxiety re surgery. Feels her problems are due to physical causes." November 22, 1980 entry: "States relief decision made to have surgery (hysterectomy) scheduled for Monday." November 23, 1980 entry: "Patient expresses anxiety re A.m. surgery. Able to understand others and is supportive to their needs. Lacks emotional insight into her own." Nurses notes in Exhibit 1 (page 61) for November 22, 1980 reads: "Attended group session . . . Participated very well. Appears more relaxed and comfortable this evening." Nurses notes for November 23, 1980 read: "Good participation during group. Insight into other's problems good. Nothing specific to solving own anxieties offered except surgery." At no time did Dr. Joye conclude that D. K. was unable to fully and knowingly consent to the surgery that was performed by Respondent on November 24, 1980. Petitioner's witness, Dr. Eli Rose, opined that D. K. was unable to give informed consent to the surgery based upon her admitting diagnosis of acute anxiety reaction and Dr. Joye's comment in Exhibit 1 (finding 5 above) "that [she] lacks emotional insight into her own." He also opined that from the symptoms of D. K. as contained in the patient records there was insufficient medical justification for the hysterectomy performed. Dr. Rose was also perturbed that the operation was scheduled so quickly, disregarding (or not knowing) that D. K. had requested the surgery be performed during that hospitalization. Before becoming aware that a second surgeon assisted Respondent in performing this hysterectomy, Dr. Rose opined that the length of the operation, forty-five minutes, was too short a time for this procedure to be safely and adequately performed. After learning that another surgeon assisted Respondent, Dr. Rose backed away from this position. After this case was referred to Dr. Rose for consultation, he became aware that he was D. K.'s physician two years earlier who had treated D. K.'s symptoms with medication. In addition to his own testimony, Respondent presented two gynecologists, one board certified and the other board eligible. Dr. Broadnax reviewed the patient records of D. K. and the depositions of other witnesses. He opined that in the treatment of D. K., Respondent exercised the level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as acceptable under similar conditions and circumstances. The parties stipulated if Dr. Rothman, a board certified gynecologist, was called he would testify that in the treatment of D. K., Respondent exercised the care, skill and treatment which is recognized by a reasonably prudent osteopathic physician as acceptable under similar conditions and circumstances. With respect to the charge involving inadequate record keeping, no creditable evidence was presented to support this charge. Petitioner's only witness acknowledged that he was unaware there is a standard of care for the keeping of medical office records.
