Findings Of Fact HRS stipulated that the challenging parties, petitioners and intervenor, are substantially affected by, and so have standing to challenge, the memoranda in question. According to the pleadings, the challengers are existing providers of surgical services faced with the prospect of increased competition from competitors likely to receive certificates of need for ambulatory surgical centers under the HRS policy articulated in the challenged memoranda. On June 6, 1985, Robert Maryanski, administrator of HRS' Office of Community Medical Facilities, "issued to staff regarding the review of ambulatory surgical [c]ertificate of [n]eed applications," (T. 71) including applications for certificates of need for limited or specialty ambulatory surgical centers, Deposition of Marta Hardy, p. 23, the following: PDCF POLICY MEMORANDUM #7 JUNE 6, 1985 SUBJECT: Policy on CON review of ambulatory surgical center proposals TO: PDCF (Liz Dudek) PDCF (Paul Reilly) PDCF (Wayne McDaniel) PDCF (Joe Mitchell) The following policies will be employed by this office in the review of ambulatory surgical center CON applications: Based upon a review of available literature and outpatient surgical information obtained from the American Hospital Association Survey, a 30 percent factor will be used as the optimum number of surgeries to be performed on an outpatient basis. In all instances, the potential for outpatient surgeries will be determined at a county level. "Specialty" ambulatory surgical center (e.g., opthalmic) will not be given special consideration. The break even level of operations approach is considered adequate to assess the potential for such facilities. In those instances when the outpatient surgical potential in a county is calculated to be slightly below the applicant's projected break even level of operation and there is no existing and/or approved ambulatory surgical center in the county-consideration will be given to approving the application, assuring all other appropriate criteria are satisfied, to foster competition for outpatient surgery as an alternative to more costly inpatient surgery. Proposals which include a captive population (e.g., health maintenance organization) will be given additional consideration as required by appropriate statutory criteria (e.g., Chapter 381.494(6)(c), Florida Statutes.) If "pre-existing clinics, which have been performing surgical procedures similar to those approval of the project, after assuring that all other appropriate criteria are satisfied. An architectural review will be conducted to verify that the existing facility meets, or will be capable of meeting, licensure requirements. In those instances, in which a hospital makes application for outpatient surgical capabilities or an increase in its existing outpatient surgery capability via the establishment or expansion of operating rooms dedicated to outpatient surgery, the hospital's current level of outpatient surgical procedures will be subtracted from the total hospitals' outpatient surgical procedures. The hospitals' outpatient surgical rate (minus the applicant hospital) will be computed separately from the applicant's outpatient surgical rate. The county's projected population will be used to project hospitals' (minus the applicant hospital) outpatient volume, as well as existing ambulatory surgical facilities' volume. These figures will be subtracted from the total outpatient surgical "pool" projection. The 2nd year break even point number of procedures for approved ambulatory surgical facilities (which either are not in operation or have not operated a full year), is next subtracted from the total "pool." At this point, the projected number of outpatient procedures which would be performed at the applicant hospital, is compared to the remainder from the previous calculations. Should the projected outpatient level equal or exceed the calculated break even level of operation, consideration will be given to approving the application, assuring all other appropriate criteria are satisfied. In the case of hospital ambulatory Surgical projects which do not involve additional operating rooms dedicated to outpatient surgery, the above ambulatory surgery methodology will not be used. Licensed and existing ambulatory surgical centers which have been operational one year or more, will be surveyed to determine the number of procedures performed over one year. These procedures will be applied to the projected population and deducted from the total outpatient potential as described above. In the case of those approved but unlicensed ambulatory surgery methodology will not be used. Licensed and existing ambulatory surgical centers which have been operational one year or more, will be surveyed to determine the number of procedures performed over one year. These procedures will be applied to the projected population and deducted from the total outpatient potential as described above. In the case of those approved but unlicensed ambulatory surgical centers, the previously calculated break even level of operation will be deducted from the total outpatient potential. In all instances, the projected year of operation will be based on the time required for construction, if appropriate, as reflected in the application plus two years from the date of this office's review. "Procedures" include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all other invasive procedures regularly construed of as surgeries. If you have any questions regarding this policy, please contact me upon receipt. This policy is effective on June 15, 1985. Petitioner's Exhibit A The June memorandum stated policy substantially similar to a memorandum authored by Mr. Maryanski's predecessor on February 21, 1985, which contained at least some of the elements of the policy that HRS applied earlier than October 9, 1983, Deposition of Nelson, p. 5, and even as early as December of 1982, Deposition of Porter, p. 11, and which reads: TO: PDCF STAFF SUBJECT: UPDATED POLICY ON CON REVIEW OF AMBULATORY SURGERY PROPOSALS At a meeting with Doug Mannheimer, members of PDCFR, and myself on February 14, the following guidelines for reviewing CON proposals for ambulatory surgery were agreed upon: Effective immediately, we will use 30 percent as the optimum number of surgeries to be performed on an outpatient basis as opposed to 29 percent. health maintenance organizations. The issue of how to deal with "pre-existing" unlicensed ambulatory surgery providers was also discussed. It was decided that if an applicant can demonstrate that it has been providing ambulatory surgical services historically in a facility which meets, or for a minor capital expenditure could meet, licensing requirements and that the provision of such services has been done profitably, this type of applicant should receive special consideration in CON reviews. However, in such cases, it will be necessary for the CON architect to verify that the existing facility meets, or almost meets, licensure requirements, and for the CON accountant to verify that the operation has historically been profitable. Data base issues were discussed. PDCFR was informed of the decision to remove the ambulatory surgery data collection burden from Nell Mitchem. The possibility of having PDCH and/or the local health councils collect such information on a semi-annual basis was discussed and will be explored further by Tom Porter. The method of counting procedures of existing ambulatory surgery centers was considered. The pros and cons of utilizing the center's break even point as described in its CON application versus its actual use was debated. It was decided that existing ambulatory surgery centers which have been in business one year or more will be surveyed to determine their actual use. In the case of those existing centers in business less than one year, the break even point will be used. The issue of counting dedicated hospital-based ambulatory surgery facilities was discussed. It was decided that in instances where a hospital applies for ambulatory surgical capabilities or an increase in that capability via the establishment or expansion of operating rooms solely dedicated to outpatient surgery, the hospital's current provision of outpatient surgery will be subtracted from the total of outpatient surgeries performed and then converted to an institution-specific rate and applied to projected population to determine the need. In the case of hospital ambulatory surgery projects not involving additional operating rooms or solely dedicated outpatient operating rooms, the ambulatory surgery methodology will not be employed. In these instances, the review will be primarily architectural. The definition of "procedures" was considered. It was determined that procedures should include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all procedures regularly thought of as surgeries. establishment or expansion of operating rooms solely dedicated to outpatient surgery, the hospital's current provision of outpatient surgery will be subtracted from the total of outpatient surgeries performed and then converted to an institution-specific rate and applied to projected population to determine the need. In the case of hospital ambulatory surgery projects not involving additional operating rooms or solely dedicated outpatient operating rooms, the ambulatory surgery methodology will not be employed. In these instances, the review will be primarily architectural. The definition of "procedures" was considered. It was determined that procedures should include all diagnostic procedures (e.g., endoscopic and cystoscopic), as well as all procedures regularly thought of as surgeries. The method of computing the break even point was discussed. Tom Porter will work with Joe Mitchell to come up with an improved method for doing this. The issue of what year we project need to was discussed. It was decided that in all cases, the projection year would be based on the time shown in the application as required for construction and licensing of the facility plus two years from the date of the HRS review or date of administrative hearing, whichever is later. If you have any questions concerning this memorandum, please see me. /s/ Gene W. Eugene Nelson, Administrator COMMUNITY MEDICAL FACILITIES Petitioner's Exhibit B. The June memorandum supersedes the February memorandum but "not totally." Deposition of Marta Hardy, p. 10. The June memorandum made changes regarding the treatment of hospitals' applications. Deposition of Elizabeth Dudek, p. 23. On September 13, 1985, more than two weeks after the petitions had been filed in Cases Nos. 85-2962RX and 85-2963RX, Mr. Maryanski signed the following memorandum: SUBJECT: Policy Memorandums TO: PDCF (Liz Dudek) (Wayne McDaniel) (Paul Reilly) (Joe Mitchell) Policy memorandums are statements of the current policy of the Office of Community Medical Facilities, and the Department of Health and Rehabilitative Services, regarding the subject to which it is addressed. The policy at issue is in a state of development, and should not be considered to have reached a level of general applicability to all cases. This memorandum is not intended to dictate the out-come of action being taken on any given case, but rather represents a momentary picture of this policy as it has developed through cases previously encountered. In order to provide for reasonably consistent actions taken in similar instances in this office, please utilize this policy memorandum as a guideline, subject to change and development on a case basis. Respondent's Exhibit No. 1 At some point staff were told "if there are reasons to deviate [from the policy embodied in the June memorandum] that they should come and discuss those reasons with their supervisor or" (T. 73) Mr. Maryanski. At least some HRS staff adhere to the policy stated in the June memorandum. Deposition of Elizabeth Dudek, p. 28. But the only reasons for deviating from the policy set out in the Maryanski memorandum of June 6, 1985, are the very reasons that would justify deviation from duly promulgated administrative rules. (T. 77) Petitioner's Exhibit A, the June memorandum, has application statewide and is addressed to all applications for certificate of need for ambulatory surgical centers. (T. 77) Without this policy in effect, "the only means [HRS] would have available would be to review am-surg applications according to statutory criteria." (T. 73) HRS has assigned to its Office of Comprehensive Health Planning, not to its Office of Community Medical Facilities (headed by Mr. Maryanski and, before him, by Mr. Nelson), responsibility for promulgating administrative rules. On July 6, 1984, HRS published notice of intent to adopt a rule governing applications for certificates of need for ambulatory surgical centers, at 10 Florida Administrative Weekly No. 27, pp. 2064-2067. Petitioner's Exhibit C. Additional or amended notice was published on March 15, 1985, at 11 Florida Administrative Weekly No. 11. After petitions challenging HRS' proposed rule 10-5.11(30) were filed, HRS abandoned the effort formally to adopt a rule specifying the criteria for granting certificates of need for ambulatory surgical centers, by filing notice of withdrawal with the Department of State on June 20, 1985. On deposition, HRS' Deputy Assistant Secretary for Health Planning testified that the June "memo was issued right after we withdrew the rule." At 6. Although in fact the notice of withdrawal of proposed rule 10-5.11(30) was not filed until after the June 6 memorandum was executed, the decision to withdraw the proposed rule, to judge from this testimony, antedated the memorandum which "in the absence of any kind of methodology, [HRS] decided to issue. . . to provide methodology guidelines to the staff within the office." Deposition of Marta Hardy, p. 6.
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes (2001),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. Dr. Dangl, whose address of record is 3900 Clark Road, Suite E-1, Sarasota, Florida 34233, was issued Florida license number ME 71286 to practice medicine in Florida. During all relevant periods of time, he was not board-certified by the American Board of Medical Specialties or by any agency recognized by the Board of Medicine. Dr. Dangl is the holder of a D.M.D. degree from the Washington University School of Dental Medicine in St. Louis, Missouri. He is not licensed as a dentist in Florida, but he has previously held dental licenses in Missouri, Pennsylvania, and Virginia. He is specialty certified by the American Board of Oral and Maxillofacial Surgery. This specialty is related to the practice of dentistry. During all relevant periods of time, Dr. Dangl's office was fully and properly registered as an office surgical facility. During all relevant periods of time, Dr. Dangl did not have hospital privileges. On August 17, 2001, C.S., a female who was at that time 63 years old, came to Dr. Dangl's office for a consultation regarding facial rejuvenation and body contouring. Dr. Dangl saw C.S. and recommended "that she consider cervicofacial rhytidectomy with full face carbon dioxide laser resurfacing and autogenous fat transfer to the facial area." He further determined that the "degree of liposity in the abdomen and flanks is minimal and this can also be treated at the same time with low-volume tumescent liposuction." Prior to her consultation with Dr. Dangl, C.S. had seen an advertisement for Dr. Dangl in the "Sarasota Herald-Tribune." The advertisement listed Dr. Dangl as "Kurt Dangl, M.D., FAACS" and underneath his name appeared the words "Board Certified." From reading the advertisement, C.S. assumed that Dr. Dangl was board-certified in cosmetic or plastic surgery. C.S. returned to Dr. Dangl's office on August 21, 2001, for preoperative counseling. She signed consent forms for the procedures to be performed. The consent forms listed potential risks and complications involved with the procedures. Complications included infection, wound breakdown, and skin necrosis. The consent forms stated that Dr. Dangl did not guarantee specific results and that wound healing was outside the control of the patient and Dr. Dangl. On the printed consent forms the abbreviation "D.M.D." followed Dr. Dangl's name. No evidence was presented that the consent forms were being used as advertisements. C.S.'s medical records in Dr. Dangl's files indicate a blood sample was taken from C.S. on August 21, 2001, and sent to AccuLab. An AccuLab report dated August 22, 2001, indicated that C.S. had a slightly lowered hemoglobin level of 35.5. Based on a notation on the report, it appeared that Dr. Dangl reviewed the report on August 23, 2001. There is a handwritten note on the AccuLab report that the hemoglobin count was "ok for planned procedure." Dr. Dangl did not advise C.S. prior to the surgical procedures that her hemoglobin count was low. Dr. Dangl's records indicate that C.S. gave a medical history prior to the surgery and that Dr. Dangl performed a physical examination of C.S. prior to the surgery. C.S. advised Dr. Dangl that she had had her coccyx removed about six weeks before her scheduled cosmetic surgery. On August 28, 2001, C.S. returned to Dr. Dangl's office to have Dr. Dangl perform a face and neck lift, laser resurfacing of the face, removing fat from her abdomen and flanks, and transferring some of the fat from the abdomen and flanks to specific areas in her face. Betsy Shecter, who is licensed as an advance registered nurse practitioner in Florida, was the nurse anesthetist for C.S.'s procedures. Ms. Shecter's first contact with C.S. on August 28, 2001, occurred at 13:05, when she interviewed C.S. and then escorted C.S. to the operating room. At 13:15, C.S. was given valium, and an IV infusion of propofol and Sufenta was placed in C.S.'s arm around 13:20. Propofol is an anesthetic and Sufenta is a synthetic narcotic. C.S. was prepped and draped around 13:30, and a local anesthesia was injected at 13:35. Because the local anesthesia required about 20 to 30 minutes to become active, Dr. Dangl did not make the first incision until 14:05. The liposuction procedure to harvest the fat for a fat transfer occurred between 14:05 and 15:00. After liposuction, a local anesthesia was injected in the areas where the face lift would be performed. At 15:20, a garment was applied to the areas where fat had been harvested to keep the swelling down. Sequential leg compressions were put in place to avoid blood clots. The actual face lift started around 15:30 and ended around 20:20, when Ms. Shecter put Opticane ointment and corneal shields in C.S.'s eyes for the laser procedure. The laser procedure began around 20:25. At around 21:00, Ms. Schecter turned off the propofol drip to which Demerol had been added. The actual laser surgery stopped at approximately 20:55. The eye shields were removed at 21:15. The recovery time in the operating room commenced at 21:00 when the drugs were stopped and ended around 21:45. The recovery time continued until C.S. was discharged at 22:30. At the time of her discharge, C.S.'s vital signs were stable, and she was alert and oriented. C.S. was told prior to the surgery that someone would have to stay with her overnight after the surgery. C.S. made arrangements for her daughter and C.S.'s sister to stay overnight with her. C.S.'s sister had training and experience as a certified nurse assistant. Prior to the surgery, Dr. Dangl told C.S. that she would probably be ready to go home around four or five o'clock (16:00 or 17:00). She made arrangements with her daughter to pick her up around 17:00. When her daughter inquired from Dr. Dangl's office at 17:00 whether her mother was ready to leave, she was advised that surgery had not been completed. C.S. was not discharged until over five hours after her daughter first contacted Dr. Dangl's office. C.S.'s daughter became visibly upset when she saw her mother after the surgery and wanted to have C.S. admitted to a hospital. Because of the daughter's agitation, arrangements were made for a licensed practical nurse, Ruth Schneider, to stay overnight with C.S. C.S.'s daughter and sister had some difficulty in getting C.S. into the car for the trip home because of the sequential leg compressions, which C.S. wore home. Dr. Dangl and Ms. Shecter put C.S. in the car. At the time that C.S. was put in the car, C.S. was able to stand on her own and able to walk with support. When C.S. arrived home, Ms. Schneider assisted C.S. into her home. At that time, C.S. was alert and oriented and could ambulate with assistance. When C.S. got in her home, she was able to drink and take nourishment. Ms. Schneider helped C.S. ambulate to the bathroom. C.S. sat in a recliner and slept some during the night. At the close of Ms. Schneider's eight- hour shift, she left C.S. in the care of C.S.'s sister. C.S. was scheduled for a follow-up visit with Dr. Dangl on August 29, 2001, but C.S.'s sister was unable to arouse C.S. and get C.S. up to go to the doctor's office. Dr. Dangl's office was advised that C.S. could not come to his office. Dr. Dangl came to C.S.'s home around nine or ten o'clock in the evening of August 29, 2001, for a follow-up visit. He removed the dressings from her wounds and applied an antibiotic ointment. Dr. Dangl apparently did not have bandages with him that he could place on the surface of the wounds because he asked the sister for sanitary napkins to use as a dressing. C.S.'s sister retrieved sanitary napkins from the bathroom, and Dr. Dangl, using scissors from a nearby basket, cut the napkins up and used them to dress the wounds. He reused the Ace-type bandages which he had removed and placed them over the sanitary pads. C.S. was instructed to come to Dr. Dangl's office on August 31, 2001, for her 72-hour postoperative evaluation. On August 31, 2001, C.S.'s sister took C.S. to Dr. Dangl's office. C.S.'s sister did not accompany C.S. into the treatment room. Dr. Dangl removed the dressings and inspected the wounds. There was no evidence of hematoma, seroma, or infection. He noted that there was a "small area of devascularization immediately anterior to the left tragus on the left side" and described the areas as "about the size of a quarter." His notes indicate that the area would be "followed expectantly and debrided as necessary." He was to follow up with C.S. in 48 or 72 hours. When Dr. Dangl came out of the treatment room, he saw C.S.'s sister and asked her what was wrong with her. She explained that she was tired from being up all night with C.S. Dr. Dangl asked the sister why she did not take one of the sleeping pills that he had prescribed for C.S. The sister replied, "What? Why would you tell me to do that, take someone else's medicine?" Prior to this conversation, Dr. Dangl had not examined the sister in any way, gotten her medical history, or asked her whether she was taking any other medications. Over the next several days, C.S. complained to her sister that she was burning, hurting all over, and was not able to sleep or rest. On September 3, 2001, C.S.'s daughter called Dr. Dangl's office and advised that C.S. had a foul smelling discharge in front of her left tragus. Dr. Dangl called in a prescription for antibiotics for C.S. and told C.S.'s daughter that he wanted to see C.S. the following day. Dr. Dangl saw C.S. in his office on September 4, 2001. His examination of C.S. revealed that the size of the devascularized area in front of her left tragus had increased four times. There was some foul smelling yellow-brown discharge coming from this area as well as from several areas under the mandible approximately following the locations of the previously placed drains. He debrided the devitalized area and irrigated the discharge areas with an antibiotic solution and hydrogen peroxide. An intravenous antibiotic was administered, and wound cultures were obtained from various sites. Dr. Dangl again saw C.S. in his office on the evening of September 4, 2005. There was a minimal amount of drainage and no foul smelling odor. On September 5, 2001, C.S. again presented to Dr. Dangl's office for postoperative infection evaluation and treatment. There was a mild purulent discharge in the left anterior neck and at the left post auricular area. Dr. Dangl debrided the wound area and irrigated the wound area with sterile saline. C.S.'s pain medication was increased. Dr. Dangl saw C.S. in his office on September 6, 2001, for further wound treatment. The laboratory results of the wound cultures indicated a light growth of E. coli. Dr. Dangl administered an antibiotic intravenously and removed necrotic tissue. C.S. returned to Dr. Dangl's office on September 7, 2001. Her temperature was 100.6 degrees Fahrenheit, and she was complaining of significant discomfort. Dr. Dangl debrided the wound area. He examined the abdomen and flank incisions and found no evidence of infection or other signs of untoward wound healing. C.S.'s daughter accompanied her mother to Dr. Dangl's office on September 7, 2001, and expressed her concerns about her mother's condition. The daughter felt that her mother might benefit from hospitalization. Dr. Dangl referred C.S. to Dr. Manual Gordillo for evaluation and determination of the need for hospitalization. Dr. Gordillo treated infectious diseases. Dr. Gordillo saw C.S. and advised C.S. and her daughter that the treatment for the infection could be done in the hospital or on an outpatient basis, but expressed his opinion that admission to the hospital was borderline. C.S. opted for hospitalization and was admitted to Doctors Hospital of Sarasota on September 7, 2001. After C.S. was admitted to the hospital, additional cultures were taken of the wound sites as well as the sites in the abdomen where fat had been harvested. Based on the laboratory results, C.S. had a scant growth of E. coli from her face wound culture and a moderate growth of staphylococcus aureus from abdominal wound culture. C.S. was placed in isolation because of the staph infection. C.S. was experiencing a great deal of pain from her wounds while she was in the hospital. Because of her difficulty with pain management, she was put on a PCP pump to help control the pain. While she was in the hospital, Dr. Dangl visited her several times to observe. He did not perform any treatment on C.S. while she was hospitalized. C.S. told Dr. Dangl that she wished that he would not visit her while she was in the hospital, but he continued to come. The evidence is not clear and convincing that C.S. conveyed to Dr. Dangl that she did not want his services any longer, particularly in light of C.S.'s paying office visits to Dr. Dangl for treatment after she was discharged from the hospital. However, the evidence is clear and convincing that C.S. did not want Dr. Dangl to visit her in the hospital and that she told him so. Dr. Dangl's medical records do not establish a medical basis for continuing to see C.S. in the hospital after she asked him not to do so. C.S. was discharged from the hospital on September 13, 2001. At that time, she was feeling much better, her wounds were stable, and her wounds were not clinically overtly infected. She was directed to follow up with Dr. Dangl as soon as the following day and to follow up with Dr. Gordillo within a week. After her discharge from the hospital, C.S. continued to see Dr. Dangl on September 15, 17, 19, and 21, 2001. Dr. Dangl changed the dressings and, on two of the visits, did some minimal debridement. C.S. discontinued seeing Dr. Dangl after her office visit on September 21, 2001. On September 24, 2001, C.S. began seeing Dr. John Leikensohn, a plastic and reconstructive surgeon, for wound treatment. He diagnosed C.S. as having massive skin necrosis. When C.S. began seeing Dr. Leikensohn, she was asked to sign a medical release for her medical records from Dr. Dangl, and she did so. Dr. Leikensohn's staff contacted Dr. Dangl's office by telephone to get C.S.'s records. The medical release was sent by facsimile transmission to Dr. Dangl's office with a request for C.S.'s records. By October 2, 2001, Dr. Leikensohn had not received the records from Dr. Dangl. Dr. Leikensohn asked C.S. and C.S.'s daughter to stop by Dr. Dangl's office and get a copy of the records. C.S. went to Dr. Dangl's office and personally asked his staff for her records, but was not given the records. She also submitted a written request for her records, but did not receive them pursuant to the written request. Barbie Beaver, Dr. Dangl's office coordinator, does not recall when or from whom she actually received a request for C.S.'s records, but she does remember sending C.S.'s medical records to Barbara Dame, Dr. Dangl's risk manager, for her review on September 27, 2001. When Dr. Dangl's office received a request for a patient's records, she would advise Dr. Dangl and he would decide what to do. She gave a request for C.S.'s medical records to Dr. Dangl, and he instructed her to send them to Ms. Dame for review prior to releasing the records. Ms. Beaver does not recall when she actually sent C.S.'s records to the person who requested them. During his treatment of C.S., Dr. Dangl wrote several prescriptions for C.S. The prescription scripts contained the abbreviation "D.M.D." after his name. No evidence was presented that the prescriptions were intended to be used for advertising purposes. Dr. John J. Obi, a board-certified plastic surgeon, testified as the Department's expert witness. It is Dr. Obi's opinion that it would have been good medical practice to have advised C.S. of her low hemoglobin prior to surgery, but that because the blood level was not dangerously low, he could not "say that's a complete deviation from the standard of care." Dr. Obi further opined that Dr. Dangl exceeded the eight-hour limitation on elective cosmetic surgery in a physician's office when he performed the procedures on C.S. on August 28, 2001. Dr. Obi's opinion is based on his incorrect understanding that the anesthesia was stopped at 22:00. Thus, even if the time for calculating surgical procedures ran from the time the anesthesia was first administered at 13:15 until it was stopped at 21:00, the length of time for the surgical procedures was seven hours and forty-five minutes. Dr. Obi opined that the recovery time for C.S. was insufficient. Again he based his opinion in part on his incorrect assumption that the anesthesia was discontinued at 22:00. Dr. Obi creditably testified that Dr. Dangl's continuing to see C.S. in the hospital after she told him that she did not want him to visit fell below the prevailing standard of care. Dr. William Frazier, the expert who testified on behalf of Dr. Dangl, gave no opinion on whether Dr. Dangl's continued hospital visits after being told not to visit by C.S. violated the standard of care. Dr. Obi opined that it was a violation of the standard of care for Dr. Dangl to tell C.S.'s sister to take some of C.S.'s prescription sleeping pills without examining or taking a medical history of the sister. Dr. Frazier was of the opinion that the conversation between Dr. Dangl and C.S.'s sister did not fall below the standard of care. Dr. Frazier's opinion was based on his misunderstanding that C.S.'s sister had asked Dr. Dangl if it was appropriate for her to take a sleeping medication that she already had.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes; finding that Dr. Dangl did not violate Subsection 458.331(1)(d), Florida Statutes; imposing an administrative fine of $2,000 for the violation of Subsection 458.331(1)(nn), Florida Statutes; imposing an administrative fine of $3,500 for violations of Subsection 458.331(1)(t), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(ll), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(m), Florida Statutes; suspending his license for two years; and requiring Dr. Dangl to attend continuing medical education classes to be specified by the Board of Medicine. DONE AND ENTERED this 16th day of August, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of August, 2005.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the application of Central Florida Surgical Ambulatory Center be DENIED. DONE and ORDERED this 27th day of March, 1985, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of March, 1985.
The Issue The issues are whether Respondent deviated from the applicable standard of care in the practice of medicine by inserting the wrong intraocular lens during cataract surgery, in violation of Section 458.331(1)(t), Florida Statutes, or failed to maintain adequate medical records, in violation of Section 458.331(1)(m), Florida Statutes, and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 0030598. Respondent graduated from medical school in 1976 and completed a three-year residency in ophthalmology in 1980. Board-certified in ophthalmology since 1981, Respondent is the medical director of the Treasure Coast Center for Surgery in Stuart (Surgery Center). The Surgery Center is an ambulatory surgery center licensed under Chapter 395, Florida Statutes. Since 1980, Respondent has performed over 20,000 surgeries, including over 10,000 cataract surgeries. In that time, he has never previously misidentified a patient, operated on the wrong site, or inserted the wrong lens. This case involves a wrong lens that Respondent inserted into an 80-year-old patient on October 17, 2000. A local optometrist had referred the patient to Respondent for evaluation of cataracts in both eyes. Respondent performed successful cataract surgery on the patient's right eye on August 22, 2000. A cataract is a partial or complete opacification, or clouding, of a natural lens or its capsule. Typically associated with aging, the cataract is a major cause of a slow loss of vision, making it more difficult for the patient to read or drive, especially at night with the glare of lights. Twenty years ago, conventional cataract surgery comprised an intracapsular cataract extraction with the lens implant placed in the front of the eye. In the last 20 years, the predominant mode of cataract surgery comprises an extracapsular cataract surgery or phacoemulsification with the lens implant placed behind the iris of the eye. In the phacoemulsification process, the surgeon, using a smaller incision than that used in the older procedure, dissolves the cataract-involved natural lens using ultrasound and removes the cataract in smaller pieces than the single-piece removal characteristic of the intracapsular extraction process. The patient was scheduled for phacoemulsification of the cataract-involved lens in her left eye at the Surgery Center as the first patient of the day on October 17, 2000. Respondent handled her case as he handles all of the other cases. Prior to the surgery, Respondent reviews the patient's office chart and brings it, together with the office charts of the other patients scheduled for surgery that day, from his office to the Surgery Center. At the Surgery Center, Respondent delivers the office charts to circulating nurses, who remove each chart, read it to determine the lens to be implanted, find the lens specified in the chart for implantation, and insert the packaged lens into the chart. A nurse then stacks the office charts in a stand in the order of the patients' surgeries scheduled for the day. From the patient's perspective, she is greeted by a receptionist upon arrival. The receptionist pulls the already- prepared materials, including an identification bracelet or armband, and has the patient sign the necessary paperwork. At this point, an admission nurse takes the patient to the preoperative area where the patient lies down on a gurney. The nurse identifies the patient and confirms the eye to be operated on and the procedure to be performed. After verifying this information, the nurse places the identification bracelet on the patient's wrist. In cases such as this, in which an anaesthesiologist administers the anaesthesia, the anaesthesiologist meets with the patient to confirm the identity of the patient, the eye to be operated on, and the procedure to be performed. The Surgery Center's policy requires: "the attending physician and/or anesthesiologist, along with the responsible nurse, will review the patient's medical record, the armband and the Surgery Schedule to confirm the correct operative site. The operative site will also be confirmed by the patient or parent/guardian." The cited language, as well as the surrounding context, reveals a policy to ensure that the correct site--here, left eye--is the subject of the actual surgical procedure; nothing in the policy explicitly requires anyone to match the correct lens with the patient. After completion of the preoperative procedure, the circulating nurse takes the patient from pre-op. Among the nurse's other duties is to check the patient's bracelet against the office chart and to ask the patient if she is the person named on the office chart and bracelet. Accompanying the patient into the operating room are the office chart and Surgery Center chart. Once in the operating room, the circulating nurse places the office chart on a side table used by the scrub nurse and the Surgery Center chart with the anaesthesia equipment. Transferred into the operating room, the patient is scrubbed by a scrub nurse, who drapes the patient from just below her knees to above her head with a gown that opens only at the site of the eye to be operated on. The purpose of the gown is to maintain a sterile field, so no one can lift the gown in the operating room, such as to identify the patient by face or bracelet with the name on the chart, without exposing the patient to a risk of infection. When Respondent enters the operating room, he is already scrubbed and wearing gloves. A stand holds the patient's office chart with the packaged lens implant at the side table. Respondent checks the power of the lens, as disclosed on the package, against the power specified on the office chart. In this case, the two powers matched, as the office chart and the lens implant were for another patient. To maintain sterility, Respondent cannot touch a chart while he is in the operating room; if the necessity arises, a nurse may touch the chart. Before proceeding with surgery, Respondent reads the name of the patient on the office chart. Respondent does not verify that the names on the bracelet and either of the charts are the same. Nor does Respondent confirm with the circulating nurse that she has done so. To check the identity of the patient, Respondent says, "Good morning, Ms. . I'd like you to put your chin up for me." However, patients often have fallen asleep from the three preoperative sedatives that they have already received. Respondent conceded that the patient in this case may not have been alert when he addressed her by name. For whatever reason-- reduced consciousness, unconsciousness, nervousness, or inability of the patient to hear Respondent or Respondent (or others) to hear the patient--the patient in this case did not effectively communicate to Respondent that she was not the patient whose name he stated. Respondent proceeded with the surgery and implanted the wrong lens into the patient's left eye. Respondent had specified a lens with a 21.5 diopter refractive power and implanted a lens with a 20.5 diopter refractive power. The circulating nurse discovered the error when she went to get the next patient and found the office chart of the patient on whom Respondent had just completed surgery. The next day, when the patient visited Respondent at his office for a routine post-operative examination, Respondent informed her that he had placed the wrong lens in her eye and recommended that he recheck her vision in a few days and then decide whether to perform a corrective procedure. Three days after the initial surgery, Respondent found an increased degree of anisometropia, which is the difference in refraction between the two eyes. At this time, the patient complained to Respondent about imbalance. Respondent advised corrective surgery, and, on October 26, Respondent performed surgery to replace the implanted lens with another lens. Although the initial surgery was sutureless, the corrective surgery required sutures. The corrective surgery was generally successful, although two and one-half months later, the patient was complaining that her left eye was sore to the touch--a complaint that she had not made following the initial surgery to the left eye. Petitioner asserts that Respondent's medical records are deficient in two respects: inaccurately describing the treatment and failing to justify the corrective surgery. Respondent dictates his operative reports prior to surgery, even though they bear the date of the surgery--here, October 17, 2000. To accommodate contingencies, Respondent dictates three conditional notes, one of which itself contains two alternatives. As found in the patient's operative report, these conditional notes state: The corneoscleral wound was enlarged, if necessary. * * * If necessary, an interrupted suture was placed for pre-existing against-the-rule astigmatism or to help maintain the water- tightness of the wound. If a suture was placed, the wound was retested to be water- tight. Although Respondent's pre-dictated operative notes for the patient are detailed, they omit a salient element of her surgery--that Respondent inserted a lens of the wrong power. Respondent did not try to conceal this fact. To the contrary, as soon as the nurse informed him of her error, he directed her to attach the sticky label on the lens package, which records the power of the lens, to the patient's chart. He also directed her to prepare an incident report, which prompted Petitioner's investigation. The expert testimony in this case was conflicting. Respondent's expert witness was originally contacted by Petitioner and asked for an opinion on the standard-of-care and medical-records issues described above. The witness opined that Respondent met the applicable standard of care and the medical records justified the course of treatment. Respondent then retained this physician as his expert witness. Respondent's expert witness opined that an ophthalmologic surgeon necessarily must rely to a "large extent" on staff for a "certain amount of identification" before the patient is transferred into the operating room. Respondent's expert witness did not explain in detail the qualifications inherent in these statements. Finding an error by the Surgery Center in the insertion of the wrong lens, Respondent's expert witness admitted that Respondent had some control over the circulating nurse, but stated that the nurse administrator basically directs the nurses. Expressing no problem with the conditional notes, Respondent's expert witness testified that it is not unusual for a surgeon to predictate an operative report and then change it if something unusual happens. Petitioner retained another expert witness to replace the expert witness who became Respondent's witness. Petitioner's expert witness opined that Respondent failed to meet the applicable standard of care and the medical records did not justify the course of treatment. Petitioner's expert witness opined that it was never within the applicable standard of care to insert the wrong lens and admitted that he was unaware of the procedures of the Surgery Center and Respondent to avoid this occurrence. Petitioner's expert witness explained that the surgeon is the captain of the ship and ultimately bears the responsibility for the insertion of the wrong lens. Petitioner's expert witness also opined that all pre- dictated operative notes were not "the standard of care" and likewise criticized the conditional notes. Petitioner's expert witness admitted that nothing included in or omitted from the operative notes would adversely affect the future management of the patient's medical care. Respondent's proposed recommended order identifies various deficiencies in the testimony of Petitioner's expert witness, although Respondent's assertion that the expert relied on a not-yet-effective strict-liability statute is not accurate. Most of these deficiencies pertain to the earlier allegations that Respondent failed to meet the applicable standard of care in performing cataract surgery on an 80-year-old patient and in performing the corrective surgery. Citing the recent case of Gross v. Department of Health, 819 So. 2d 997 (Fla. 5th DCA 2002)(Orfinger, J., concurring), Petitioner's proposed recommended order invites the Administrative Law Judge to be guided by common sense in assessing the standard-of-care issue. This invitation may arise from a well-placed concern with the means by which Petitioner's expert reached his conclusion that Respondent deviated from the applicable standard of care. Petitioner's expert witness has opined that the insertion of the wrong lens violates the applicable standard of care, without regard to the safeguards or precautions that a physician may employ to avoid this mishap. In finding a deviation from the applicable standard of care, the Administrative Law Judge relies on inferences and logic not explicitly identified by Petitioner's expert witness. In addressing the standard-of-care issue, Respondent's expert witness adopted the proper approach, which features a close analysis of the facts to determine the reasonableness of the surgeon's acts and omissions. Under that approach, however, the record establishes that Respondent failed to take all reasonable precautions necessary to prevent this mistake. Although the likelihood of the insertion of the wrong lens seems low, based on Respondent's experience, the burden of additional, effective safeguards would be minor. Both parties focused on the location of the bracelet relative to the length of the protective gown. However, an anklet would be in plain view in the operating room because the gown would not extend that far below the patient's knees. Even if the patient identification remains on a wrist bracelet, the surgeon himself could check the patient's name on the bracelet with the name on the office chart just prior to the surgeon and patient entering the operating room. Either practice would add a few seconds to the overall process and would prevent this type of error. On the other hand, the categoric rejection of Respondent's records by Petitioner's expert witness is correct. The date of the operative record is incorrect; it was not dictated on October 17, 2000, but on an earlier date. The three conditions and one alternative present a confused operative history. The operative record fails to indicate if there was a corneoscleral wound; if there was an interrupted suture; if so, if the suture was for a pre-existing astigmatism or for wound protection; and if there was a suture placed at all. With these conditions and alternative, the operative report fails to memorialize accurately material elements of the surgery. Additionally, the operative report omits an indisputably material element of the surgery--the insertion of the wrong lens. Respondent recorded this fact in an office note a few days later, but never amended his predictated operative report to reflect this important fact. Lastly, the justification for the corrective surgery ultimately was the patient's complaint of imbalance, not the difference in refractive power between the lens implanted and the lens specified. Respondent nowhere recorded any such complaint in any records. Based on the foregoing, Petitioner has proved by clear and convincing evidence that Respondent deviated from the applicable standard of care in inserting the wrong lens and failed to maintain medical records justifying the course of treatment with respect to the deficiencies noted in the operative record and post-operative records preceding the corrective surgery.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of violating Section 458.331(1)(t), Florida Statutes, and Section 458.331(1)(m), Florida Statutes, imposing an administrative fine of $10,000, and remanding the case to the Division of Administrative Hearings for findings concerning costs, pursuant to Section 456.072(4), Florida Statutes, if the parties cannot agree as to an amount. DONE AND ENTERED this 18th day of December, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of December, 2002. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Bruce A. Campbell Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Brian A. Newman Pennington, Moore, Wilkinson, Bell, & Dunbar, P. A. 215 South Monroe Street, Suite 200 Post Office Box 10095 Tallahassee, Florida 32302-2095
The Issue Whether Petitioner is entitled to a Certificate of Need ("CON") authorizing establishment of an (ophthalmological) ambulatory surgical center in Palm Beach County, Florida. Subordinate issues are: Whether the proposed facility satisfies the CON criteria of Sections 381.494-499, Florida Statutes, as implemented by Respondent, Department of Health and Rehabilitative Services ("HRS) rule and non-rule policy; Whether the proposed facility will result in unnecessary duplication of services, underutilization of existing services and increased health care costs to the community; Whether adequate resources are available for the construction and operation of the proposed facility; and Whether the proposed facility is financially feasible.
Findings Of Fact (Numbering corresponds to numbering used in proposed findings.) Preliminary findings: 1-4. Approved. On issue of compliance with applicable criteria: 1-7. Approved. 8. Approved, with caveat that this is subject to supplying an adequate record basis for the policy at hearing. 9-13 Approved. Approved but no presumption of correctness attaches to HRS earlier or more recent evaluation of the application. See, Boca Raton, supra. Approved. Approved but modified to more accurately reflect that HRS takes HMO's into account, but this factor was not used or relied on (in connection with the non-rule policy or standing alone) as the basis for granting Petitioner's application. Approved. 18-32. Approved, in the sense that an HRS expert witness at hearing offered conclusions as to compliance with each statutory criteria; rejected, in that his conclusions (except for those concerning quality of care, financial feasibility, the inapplicability of some criteria, and the cost advantages of modifying an existing facility instead of constructing a new one) are rejected as unsubstantiated by the facts. On the Issue of Need: 1-8. Approved. Approved. Modified to reflect that this is one estimate among several offered by experts. Rejected as unsupported by the credible evidence of record. Approved. Approved. First sentence, approved, in that this is the stated "attempt" of HRS' challenged non-rule policy. Second sentence, rejected as unsupported by the credible evidence; the profitable performance of outpatient surgery at a physician's office does logically compel a conclusion that his office should be licensed as an ambulatory surgical facility. On the issue of adequate resources: 1-8. Approved. On the issue of financial feasibility: 1-19 Approved. 20. Rejected as argumentative. RULINGS ON INTERVENOR'S PROPOSED FINDINGS 1-4. Approved. 5. Approved except for reference to equipment costs, of which there will be none. 9-16 Approved. 17. Such broad-brush incorporation of all facts asserted in argument is not susceptible to explicit rulings. RULINGS ON POST-HEARING MOTIONS. Intervenor's "Motion to Stay Issuance of Recommended Order" is denied. Intervenor's "Request for Hearing Officer to Take Official Recognition" of the Final Order of Hearing Officer Robert T. Benton II, in consolidated DOAH Case Nos. 85-2962R, 85-2963R and 85-3193R (attached to a "Notice of Supplemental Authority" dated November 1, 1985) is granted. The order is made a part of the record of this proceeding. A final order entered by another hearing officer of the Division of Administrative Hearings the authenticity of which is not in question, is an appropriate document to be accorded official recognition. See, Health Quest Realty XII v. HRS, 10 FLW 1729 (Fla. 1st DCA July 16, 1985, pet. for reh. pending). COPIES FURNISHED: Eric B. Tilton, Esquire 104 S. Monroe St. Tallahassee, Florida 32301 Theodore E. Mack, Esquire 1323 Winewood Blvd. Tallahassee Florida 32301 William B. Wiley, Esquire Post Office Box 2174 Tallahassee, Florida 32316
Recommendation Based on the foegoing it is RECOMMENDED: That Petitioner's application for a CON authorizing establishment of an ambulatory surgical facility at his offices in Palm Beach County, Florida, be DENIED. DONE and ORDERED this 15th day of January, 1986, in Tallahassee Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee Florida 32301 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of January, 1986.
Findings Of Fact Same Day (CON 3116) and Doctors (CON 3115) filed applications for a CON to establish a freestanding ambulatory surgical center (FASC) in Dade County, Florida, in the batching cycle that cloned December 15, 1983. Upon the Department's denial of their applications, Same Day and Doctors filed a timely request for a Section 120.57(1) hearing. The Department has not formally adopted a rule which establishes a need formula for calculating and predicting the gross and net need for freestanding ambulatory surgical centers. However, the Department has developed, and consistently applied, a reasonable methodology for assessing the need for these facilities. Under its methodology, the Department attempts to project, two years in the future, the number of outpatient surgical procedures that will not be accommodated at the county's existing and approved surgical facilities. The first step in calculating this future need is to establish the county's current total surgical use rate, hospital outpatient surgical use rate, and FASC surgical use rate. These use rates are an expression of the actual number of surgeries performed, in each category, for each increment of 1,000 county residents. Utilizing the current total surgical use rate, the Department then projects the total surgical demand for the county according to its 1988 population projection. Thirty percent of total surgical demand, in accordance with industry standards, reflects the gross need for outpatient surgical services in 1988. To establish the net need for outpatient surgical services, the Department subtracts from the gross need established for outpatient surgical services those procedures projected to be performed on an outpatient basis at existing hospitals and freestanding centers. This figure is calculated by applying the current outpatient surgical use rate of existing hospitals and freestanding centers to the county's 1988 population projection. The Department further subtracts, from the gross need, the number of surgical procedures which represent the break even point for approved but not opened freestanding centers. The result reflects need, or lack of need, for the county at the two-year planning horizon. The Department's methodology, when applied to the facts of this case, establishes that there is no numerical need for an additional FASC in Dade County, Florida. The record is otherwise devoid of any proof which would establish a numerical need for a FASC in the county. However, notwithstanding a lack of numerical need, the Department has established a policy that If "preexisting clinics," which have been performing surgical pro- cedures similar to those proposed to be performed in the applicant's facility, seeks licensure as ambulatory surgical facilities, they must document that the facility has been operating profitably, and has performed a sufficient number of procedures to exceed the calculated break even level of operation. Special consideration will be given to approval of the project, after assuring that all other criteria are satisfied. Same Day's CON Application Same Day proposes to establish a FASC in Dade County, Florida, at a total cost of approximately $600,000.00. Same Day proposes to perform only non- emergency, elective outpatient surgical procedures. During the first three years of operation, Same Day will only perform ophthalmic surgical procedures. After three years, Same Day will operate as a general all-purpose FASC. It has been operating profitably during the most recent twelve-month reporting period, and the number of procedures performed exceeds the calculated break even level of operation. Same Day has held a Medicare Provider Number and Occupational License for over two years, and is a "preexisting," clinic entitled to special consideration for CON approval. Same Day currently employs all personnel necessary to staff its proposed FASC. Same Day will encounter no difficulty in recruiting additional personnel should the need arise. Jerry Zelman, M.D., Ophthalmologist and President of Same Day, is a leading ophthalmologist in Dade County. Dr. Zelman holds staff privileges at numerous Miami hospitals, is a member of an investigation and peer review board at a Miami hospital, and is a pioneer in outpatient ophthalmic surgical procedures and advanced ophthalmic surgical procedures. Same Day has established that it has the ability to provide quality of care in an FASC setting. Same Day proposes to finance the FASC facility through a mixture of equity and commercial financing. Same Day currently possesses in excess of $200,000 worth of equipment, including operating room tables, lasers and microscopes, and has budgeted approximately $120,000 for additional equipment, as needed. The Tower Bank of Miami is committed to Same Day to fund up to $600,000, 100 percent of the proposed project. Apart from bank financing, the principals of Same Day have sufficient personal resources to provide total funding for the project. Same Day has established by competent substantial evidence that its proposed FASC will be financially feasible on an immediate and long-term basis, that the costs and methods of construction of the proposed facility are reasonable, and that its projected costs and charges for ambulatory surgical services are reasonable. Doctors' CON Application Doctors proposes to establish an FASC in Dade County, Florida, comprised of two operating rooms for multi-specialty purposes, particularly ophthalmic surgery. Doctors has not selected or purchased a specific site in which to locate its proposed facility, but is tentatively interested in locating it in the northwest area of Dade County. Dr. Weiss, one of two principals in Doctors, currently practices at southern Miami Beach, and the majority of his patients reside on Miami Beach. Northwest Dade County is not within Dr. Weiss' primary service area, and it is doubtful that he would utilize the proposed facility even if it were approved. Dr. Weiss' intent was to encourage other physicians to utilize the proposed facility, though he had not secured any commitments. There are at least 31 acute care hospitals in Dade County which offer outpatient surgical services. Additionally, there are two freestanding centers in operation and an additional seven centers which are approved but not yet opened. There is no current, or projected, need for outpatient surgical services, or an access problem, in Dade County. In addition to failing to establish need for its proposed facility, Doctors failed to offer any evidence to establish that it could provide quality of care; that it had available resources, including health manpower, management personnel, and funds for capital and operating expenditures, to accomplish its project; that its proposal had immediate and long-term financial feasibility; that its proposal would foster competition and serve to promote quality assurance and cost-effectiveness; and, that the costs and methods of the proposed construction were the most effective methods of construction.
The Issue Whether Respondent, a medical doctor, in his treatment of Patient M.A., failed to keep legible medical records in violation of section 458.331(1)(m), Florida Statutes (2007); prescribed or administered inappropriate or excessive quantities of controlled substances in violation of section 458.331(1)(q), Florida Statutes (2007); committed medical malpractice by practicing below the standard of care in violation of section 458.331(1)(t), Florida Statutes (2007); failed to perform a statutory or legal obligation placed upon a licensed physician in violation of section 458.331(1)(g), Florida Statutes (2007); and violated any provision of chapter 458 or chapter 456, or any rules adopted pursuant thereto in violation of section 458.331(1)(nn), Florida Statutes (2007), as Petitioner alleges in the Third Amended Administrative Complaint; if so, whether (and what) disciplinary measures should be imposed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Paul M. Goldberg, M.D., violated sections 458.331(1)(g) and (nn), Florida Statutes, as charged in Counts IV and V of the Complaint; Dismissing Counts I-III of the Complaint; Imposing $20,000 in administrative fines; issuing a reprimand against Dr. Goldberg's medical license; requiring Dr. Goldberg to complete the "Laws and Rules" Course; suspending Dr. Goldberg's medical license until such time as Dr. Goldberg undergoes a "UF CARES" evaluation; and placing Dr. Goldberg's license on probation for three years under indirect supervision with 100 percent chart review of cosmetic surgery patients and 25 percent chart review of all other patients. DONE AND ENTERED this 4th day of March, 2015, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE 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 4th day of March, 2015.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as the stipulation of facts entered into by the parties, the following relevant facts are found: Humana of Florida, Inc., a wholly owned subsidiary of Humana, Inc., is the owner of Women's Hospital in Tampa. Women's Hospital presently has 192 licensed beds, of which 96 are used for obstetrical patients and 96 are used for gynecological patients. It is dedicated to meeting the physical, psychological, educational, social and environmental needs of women and newborns and offers a total program of obstetrical, neonatal and gynecological care. Although not designated by the State as a Level III facility, Women's Hospital in Tampa has the personnel and equipment necessary to provide Level III care. It treats many high-risk obstetrical patients and their newborns, as well as premature infants. High-risk infants do not require transfer to another hospital with Level III capabilities. Every practicing obstetrical/gynecological physician in Tampa is on the staff of Women's Hospital. Petitioner submitted an application for a Certificate of Need to add a fifth floor to its existing facility and to increase its licensed obstetrical bed complement from 96 beds to 130 beds. Of the 34 additional obstetrical beds requested, 12 are to be allocated to an antepartum unit. These 12 beds would be organized as a separate self-contained unit to care for obstetrical patients experiencing or likely to experience a complicated pregnancy and/or delivery. The types of obstetrical patients who would utilize a separate antepartum unit would include diabetics, patients who experience difficulties with blood pressure, kidney disorders and conditions associated with the heart and thyroid. In many instances, the antepartum patient is ambulatory or quasi-ambulatory and is thus able to meet many of her own needs. As a result, the intensity of nursing care in an antepartum unit is lower than that which would be expected in a postpartum obstetrical unit, resulting in a cost-savings to the antepartum patient. The total proposed capital expenditure for the addition of a fifth floor and 34 obstetrical beds is approximately $2.8 million. While petitioner is licensed for 96 obstetrical beds, only 62 of those beds were in operation at the time of the final hearing in this proceeding. Based on the 62 beds in operation, the average obstetrical bed occupancy rate was 112 percent from September, 1982 through August, 1983. Due primarily to the temporary discontinuance of obstetrical services at St. Joseph's Hospital located across the street from petitioner, occupancy levels have reached 130 percent since January of 1983. Such occupancy levels create significant problems in terms of patient care and facility, physician and nursing efficiency. The difficulties associated with scheduling surgery and infection control are exacerbated with overcrowded conditions. Because newborns and postpartum mothers are more susceptible to infection, it is medically necessary to separate and segregate postpartum and gynecological patients. Petitioner had 4,600 deliveries last year and projects it will have 5,800 deliveries this year. If all 96 obstetrical beds were currently in operation, petitioner's occupancy levels would be approximately 70 percent. An indication of adequate utilization of obstetrical beds is an average annual occupancy level of 75 percent. Petitioner expects to reach the 75 percent occupancy level of its existing licensed 96 beds within the next year and a half to two years. Petitioner presently has no private obstetrical rooms at its facility. When a patient requires isolation from other patients, one of the beds in the semiprivate room is not available for use. Due to high occupancy levels, petitioner is unable to offer a private room to any of its obstetrical patients when it is not medically necessary to do so. Thus, even without the addition of 34 beds, petitioner desires to construct a fifth floor to allow it to reconfigure its units and convert a number of semiprivate rooms into private rooms by transferring existing licensed beds to the fifth floor. This would enhance the hospital's ability to utilize its bed complement in a more efficient manner. Even without additional beds, petitioner's Executive Director believes that by amortizing construction costs over a period of 20 to 25 years and reducing its operating margin, there would not be a significant impact upon patient charges as a result of the fifth floor addition. Should petitioner be granted a Certificate of Need allowing it to construct a fifth floor with no new beds, petitioner would be willing to accept conditions concerning the conversion of existing semiprivate rooms to private, such as capping over medical gas outlets, deactivating wall outlets and light fixtures for a second bed and furnishing the new rooms on the exclusive basis of a private room. The conversion of semiprivate rooms to private rooms could be a less costly alternative to the addition of new beds in some instances. To the extent that the addition of private beds provides a potentiality for greater utilization of existing services, additional patient revenues can be generated. It is not the policy if the Department of Health and Rehabilitative Services to grant approval for "shelled in" or "banking" space due to the potential competitive advantage it affords by allowing a future increase of beds without significant cost. Petitioner has the ability to adequately staff its proposed project with all necessary technical, nursing, and medical personnel, and will provide an acceptable level of patient care. Sufficient funds are available to construct and operate the project and the project has immediate and long-term financial feasibility. Its costs and methods for the proposed construction are reasonable, appropriate, and cost-efficient. The respondent HRS has promulgated Rule 10-5.11(23), Florida Administrative Code which establishes a uniform methodology for determining the number of acute care hospital beds needed five years into the future within the eleven HRS service districts throughout the State. The Rule addresses the need for general medical and surgical, intensive care, pediatric and obstetrical acute care services in hospitals and the Department will not normally approve applications for additional beds if the new beds would cause the number of beds in a particular district to exceed the number calculated to be needed under the Rule's methodology. Rule 10-5.11(23) calculates need through a series of formulas by considering the need for the various types of individual services and then adding these figures together to produce a figure indicating the total number of acute care beds which would be needed in a particular District within a five-year time frame. Then, after certain adjustments, all existing licensed and approved acute care beds are subtracted from the total bed need to determine the net bed need within the District. Subdistrict allocations by type of service are to be made by the individual Local Health Councils consistent with the District total acute care bed allocations, with certain adjustments permitted. As of the date of the hearing in this cause, the Sixth District's Local Health Council's plan for the allocation of beds on a service specific or subdistrict basis had not been adopted. The acute care bed need methodology set forth in Rule 10-5.11(23) takes into account the population for the service area projected five years into the future, the historic utilization rate for particular types of service, average lengths of stay, optimal occupancy rates for the various types of services, and, with regard to obstetrical bed projections, the fertility rate of women between the ages of 15 and 44. The Rule sets forth the manner in which the figures for these various components are to be derived. Utilizing the methodology for determining acute care bed need as set forth in the Rule, District VI presently has 950 acute care beds in excess of the beds projected to be needed in the year 1988. By applying the subportion of the Rule relating to obstetrical beds to Hillsborough County, there are presently 47 obstetrical beds in excess of the number needed for 1988. While the petitioner agrees with the basic generic form of the methodology contained in Rule 10-5.11(23), petitioner would substitute different data than that mandated under the Rule and perform certain adjustments. For example, petitioner would adjust the numbers used in the formula by increasing the statewide fertility rate for the years 1979-81 by 5 percent, by factoring in a number of 2 percent to 3 percent to represent the in-migration of obstetrical patients, by increasing the statewide average length of stay from 3.5 to 3.8 days so as to reflect the actual experience at petitioner's facility, by making an adjustment for hospital stays by an obstetrical patient which do not result in a delivery and by making a downward adjustment for those births which do not occur in a hospital setting. Petitioner would also subtract from the number of existing and/or approved beds the 15 obstetrical beds at St. Joseph's Hospital which were taken out of service on an interim basis as of December 31, 1982, pending the development of a comprehensive plan for the delivery of obstetrical services on a decentralized basis. The parties to this proceeding have stipulated that St. Joseph's Hospital contemplates that its future obstetrical service will be centered around birthing rooms, rather than actual labor, delivery and recovery rooms, and that it is reasonable to expect that, once the service is resumed, approximately 360 deliveries will occur with this number increasing over time. After making all these adjustments and utilizing different data in the formula for determining need, petitioner concludes there is a 1988 need in District VI for 26 or 27 additional obstetrical beds. Petitioner's analysis of bed need based both on an institution-specific analysis and a trend analysis resulted in a finding of from 32 to 36 additional beds needed at petitioner's facility by the year 1988.
Recommendation Based upon the findings of fact and conclusions of law recited above, it is RECOMMENDED that petitioner's application for a Certificate of Need in its entirety be DENIED. Respectfully submitted and entered this 2nd of December, 1983, in Tallahassee, Florida. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of December, 1983. COPIES FURNISHED: John H. French, Jr., Esquire & James C. Hauser, Esquire Messer, Rhodes & Vickers P.O. Box 1876 Tallahassee, Florida 32302 Claire D. Dryfuss Assistant General Counsel 1323 Winewood Blvd. Bldg. 1, Room 406 Tallahassee, Florida 32301 David Pingree Secretary Department of Health & Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS 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 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
