The Issue The issue is whether Respondent is guilty of deviating from the applicable standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and failing to keep adequate medical records, in violation of Section 458.331(1)(m), Florida Statutes. If so, an additional issue is what penalty the Board of Medicine should impose.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 0066606. Respondent has been board certified in plastic surgery since 1983 and is also board certified in hand surgery. Respondent has previously practiced in Kentucky. He relocated to Florida in 1994 to join a former physician colleague, Dr. Bolt, who had developed cancer and later died in early 1995. Respondent joined the Center for Cosmetic Surgery (Center), which Dr. Bolt had sold to two persons, including Jeff Davis. The record does not disclose whether Mr. Davis is a physician, but Respondent described him and the other principal/owner as felons. The Center held out Respondent as the medical director. This representation was obviously with Respondent’s knowledge and at least tacit consent. After Dr. Bolt’s death, Respondent recruited three more physicians for the Center, but none of them was board certified in plastic surgery. Mr. Davis served as the patient coordinator at the Center. The position of patient coordinator had significant marketing responsibilities. Typically, a prospective patient would contact the Center and schedule a free consultation. At the appointed time, the prospective patient would visit the Center and speak with a physician, such as Respondent. No physical examination would take place. During the discussion, the physician would make notes on a Physician’s Report, which the prospective patient would take to Mr. Davis, whose job was to sell the surgery. Using incentives such as free nose jobs, Mr. Davis was responsible for pricing surgical procedures and scheduling surgery, once the prospective patient agreed to have a Center physician perform the agreed-upon surgery. Mr. Davis was also responsible for collecting money from patients in payment for their surgery. Typically, one of Respondent’s patients would schedule surgery two to three months from the date of making the appointment. Before surgery, Respondent would see the patient before surgery for a physical examination and preoperative testing. Respondent determined what preoperative testing was necessary on a patient-by-patient basis. Following this visit, Respondent would dictate the findings from the physical examination and the treatment plan. A transcribing service was responsible for transcribing the dictation and filing it in the patient’s chart. In May or June of 1996, Respondent provided notice to the principals of the Center that he would be terminating his employment. He terminated his employment on November 1, 1996. After his departure, Respondent learned that Center employees had misinformed his patients as to Respondent’s nonavailability due to illness or surgery. It is unclear whether this situation existed before Respondent’s announced departure. Tensions developed between Respondent and the principals of the Center. Respondent determined that he could lawfully contact those patients still needing care, so he sent those patients an announcement that he was associating himself with the American Institute of Plastic Surgery. Litigation between Respondent and the Center principals followed, including a legal action by Respondent to obtain patient records. The litigation over the records concluded with the agreement by the Center to provide records as needed, but they have provided Respondent with incomplete records. A. S. first contacted the Center in June 1995 after seeing an advertisement on television. She chose the Center and two other facilities for plastic surgery that she was considering. At the time, A. S. was 48 years old. Wanting to improve her appearance, A. S. wanted a face lift and work on her lower eyelids. She had had her lower eyelids done in 1978 or 1979 and had had a “mini-lift” in 1984. A. S. met Respondent during her first visit to the Center. A. S. and Respondent spoke for 15-20 minutes. Respondent asked her what procedures she wanted done, and she said that she wanted a face lift and work on her lower eyelids. He showed her a copy of his resume and marked a picture of a face, as they discussed procedures. A. S. did not fill out any forms or questionnaires. Respondent did not explain much concerning the procedures that A. S. was contemplating. He mentioned that she would have a thin line, which would not be noticeable, under her eyes and told how long the stitches would remain in place. He did not discuss the possibility of scarring or other risks associated with the surgery. Following her visit with Respondent, A. S. saw Mr. Davis. They discussed costs and financing. Mr. Davis gave her an estimate of the cost of the surgery that she was considering. A. S. had already checked another plastic surgery center and, later on the same day that she visited the Center, she visited the third, and last, plastic surgery facility that she was considering. The next day, Mr. Davis called A. S. and asked if she had made a decision. Mr. Davis said that Respondent had told him that Respondent wanted to do A. S.’s nose, evidently for aesthetic reasons. Mr. Davis offered the nose work at no additional charge. Although Respondent had not offered to do A. S.’s nose for free or for a charge, he was aware that Mr. Davis would offer free additional work of this kind as an incentive to the patient to select the Center for the work that she was already considering. A. S. talked the matter over with her daughter. A. S. decided to have the surgery at the Center. She then informed Mr. Davis of her decision. Three to five days later, A. S. visited the Center to discuss payments with Mr. Davis because she did not have all of the money necessary for the surgery. During this visit, Mr. Davis suggested a brow lift. He said that Respondent was good at this procedure and would be working in this area anyway. At the end of this visit, a nurse gave A. S. some paperwork prohibiting her from smoking for two weeks before the surgery due to the anticipated bleeding. A. S. had smoked one pack of cigarettes a day since she had been a teenager. A. S. discussed the effect of smoking on the surgery with the nurse, but not with Respondent. As directed, she stopped smoking and never resumed smoking again. A. S. next visited the Center on June 26, 1995, for the surgery. No one performed a physical examination of A. S. On this date, Respondent performed a browlift, rhinoplasty, and facelift. After A. S. awoke from the general anesthesia, she did not receive any instructions from Respondent or staff regarding the care of her bandages, which extended across a large part of her face and top of her head. She was scheduled to return to the Center two days later. A. S.’s daughter drove her home. Once they got there, she noticed that her mother’s face seemed grey. A. S. told her to call Respondent. The daughter informed his answering service of her mother’s condition. She then waited one-half hour for Respondent or his staff to contact her. After hearing nothing, the daughter called the answering service again and waited another half-hour. After a third call and another half-hour wait, Respondent called A. S. and told her to cut the bandage under her neck. By cutting the bandages, A. S. revealed an open cut on her neck. When she returned for her followup visit two days later, A. S. asked Respondent about the cut, which extended along the right side of the neck below the ear. Respondent assured her that it would close up, which it did. When Respondent expressed concerns about her eyes and a dent in her nose, Respondent assured her that they would discuss these matters after the swelling went down. About one week later, Respondent returned to the Center for a second followup visit. During the second followup visit, Respondent removed the stitches. Now that some of the swelling had gone down, A. S. discovered that Respondent had not performed the surgery on her lower eyes. A. S. could not recall Respondent’s explanation for not performing this surgery. A. S. complained to Respondent that, since the surgery, her right eye had become smaller than her left eye, the right eyebrow had become lower than the left eyebrow, and the right side of her face from the eye down had become looser. Also, she complained about the extensive marks, scarring, loose skin, redness, and a dent under her chin; the dent in her nose and a misshapen right nostril; a swollen bump on her left cheek; a big chunk of skin gone from her hairline; and a gully on the left side of her face. Respondent assured her that he would fix these problems with revisions to the eyes and nose and the area under the neck. He did not offer any revisions to hair line, whose appearance worsened as the swelling reduced. Respondent later performed some relatively minor revisions to the right side of A. S.’s face at no cost to A. S. He reset the remaining revisions for a date in mid-December, 1995. Despite A. S.’s persistence at trying to obtain the additional revisions, Respondent failed to perform them. Repeatedly, Center employees canceled scheduled surgery dates, claiming that Respondent was ill or busy with unscheduled surgery. They rescheduled the December surgery to a date in mid- February, 1996. When she reported on this date, a Center employee took her to Mr. Davis, who informed her that the Center had lost money on her surgery and would not perform revision surgery until she paid additional money. They rescheduled her surgery for a date in late March. When A. S. reported on the date for her surgery in March, Mr. Davis told her that they would not do the revision surgery until she paid another $300. A. S. charged this sum on her credit card, so they would do the surgery. Mr. Davis told her that Respondent was too busy, and he rescheduled the surgery for April 8. On April 8, when A. S. reported for surgery, a Center employee sedated A. S., but, after A. S. waited a couple of hours, another Center employee informing her that the surgery could not take place either because Respondent was not coming into work that day or he was in emergency surgery. When A. S. called from home later that day to reschedule the surgery, a Center employee told her that Respondent was in surgery. The employee advised A. S. to call the Center each morning to see if Respondent had any cancellations. A. S. did as advised, but the Center was never able to accommodate her. Subsequently, A. S. sent Respondent two or three letters and left telephone messages for him to contact her on at least ten occasions. Realizing that Respondent and the Center would not perform the revision surgery, A. S. went to another plastic surgery facility in 1998 for work on her right nostril and under her neck. A surgeon repaired the nostril, but, due to financial constraints, could not do all of the work required to repair the damage under A. S.’s neck, which would require about $4000 in surgery. In the meantime, Respondent sent A. S. a card announcing the relocation of his practice to the American Institute for Cosmetic Surgery. A. S. wrote Respondent a letter at his new address, but Respondent never responded. A. S. never sued Respondent. All she wanted was that he perform the revisions that she could not afford to purchase elsewhere so as to reduce or, if possible, eliminate the deformities that Respondent caused surgically. Respondent violated the applicable standard of care in several ways. First, preoperatively, his evaluation of A. S. was scanty. He did not take an ample history, and he did not adequately evaluate her medical status. He did not prepare a surgical plan with a description of all risks and a discussion of these details with the patient. Perhaps most importantly, Respondent never performed a physical examination of A. S. before surgery. Respondent violated the applicable standard of care operatively. The results in this case are so substandard in number and degree as to preclude assigning the outcomes to bad luck, as opposed to a hurried, careless surgery. Respondent violated the applicable standard of care postoperatively. He did not adequately the many problems that he caused. Perhaps most obviously, he failed to adequately treat the open wound in the neck, and he failed to form a plan to address the many revisions necessitated by his careless surgery. The Board of Medicine has previously disciplined Respondent for, among other things, his deviation from the applicable standard of care in treating three plastic surgery patients whose surgery he performed in 1995-96 and 1998.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of violating Section 458.331(1)(m), Florida Statutes, in his treatment of A. S. and revoking his license. DONE AND ENTERED this 6th day of December, 2000, 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 6th day of December, 2000. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health Bin C03 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health Bin A02 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health Bin A02 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Kim M. Kluck Carol Gregg Senior Attorneys Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Jerry C. Lingle 1419 Northeast 16th Terrace Fort Lauderdale, Florida 33304
Findings Of Fact The Department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order directly Children's Medical Services for District VII to authorize coverage for the reconstructive surgery recommended and proposed by J. Barry Boyd, M.D. DONE and ORDERED this 6th day of November, 1985, in Tallahassee, Florida. DIANE K. KIESLING 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 6th day of November, 1985. COPIES FURNISHED: Gerry L. Clark, Esquire HRS District Seven Assistant Legal Counsel 400 West Robinson Street Orlando, Florida 32801 Ms. Cynthia Thibeault 1415 Overdale Street Orlando, Florida 32817 David Pingree Secretary 1323 Winewood Boulevard Tallahassee, Florida 32301 ================================================================ =
The Issue The issues for determination are whether Respondent violated Subsections 458.331(1)(f) and (m), Florida Statutes (1997), by assisting an unlicensed person to practice medicine contrary to Chapter 458 and by failing to maintain adequate medical records; and, if so, what discipline, if any, should be imposed against Respondent's license. (All references to chapters and statutes are to those promulgated in Florida Statutes (1997) unless otherwise stated.)
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida. Respondent is licensed to practice medicine in Florida pursuant to license number ME 0015824. Respondent owns and operates an ambulatory surgical center doing business as the Dermatologic & Cosmetic Surgery Center (Surgery Center). The Surgery Center is located at 2666 Swamp Cabbage Court, Fort Myers, Florida 33901. Respondent is a Board-certified Dermatologist and also performs cosmetic surgery that includes breast augmentation. Dermatology and cosmetic surgery involve similar procedures. The procedures used to remove skin cancers from the face are similar to those used in face-lifts and eyelid surgery. Respondent performs approximately a thousand skin cancer surgeries a year, has been doing cosmetic surgery since 1986, and has practiced breast surgery since 1989. Respondent is a member of the American Board of Cosmetic Surgery. That board is not approved by the American Board of Medical Specialties or the Florida Board of Medicine. Respondent has attended numerous seminars and satisfied relevant continuing education requirements throughout his career. Respondent has never been sued by a patient and has no prior discipline against his license. Prior to August 12, 1997, Respondent performed breast augmentations through the patient's nipple. Respondent made a small incision in the lower part of the binary nipple. He used his fingers to separate the overlying breast tissue from the muscle and create a pocket in which to place an implant. The incision left a scar at the nipple, and Respondent sought to develop competency in a different procedure identified in the record as the axillary method of breast augmentation. The axillary method allows the surgeon to access the breast from the patient's armpit. The surgeon makes a 1.5 inch incision under the armpit, uses an instrument to create a pocket in the breast, inserts a partially inflated implant into the pocket, and repeats the same procedure in the other breast. The surgeon then checks the breasts for symmetry, fills the implants, closes the pockets, and concludes the procedure. In the axillary method, a surgeon must use instruments rather than his fingers to create a pocket for the implant. The initial incision and placement of the implant do not require great skill. The greater skill is required in reaching the proper plane in the breast tissue and in creating the pocket. The brachial plexis is just below the incision in the armpit and contains all of the nerves that make the arm work. From the armpit, the surgeon must proceed over the sternum. If the surgeon applies too much pressure, the surgeon can cross the center of the chest and create a condition known as a unibreast. Respondent developed a basic understanding of the axillary method by watching video tapes for several years and by attending seminars approved for professional education credit in the State of Florida. In May of 1997, Dr. Daniel Metcalf taught one of those seminars in Orlando, Florida. Dr. Metcalf is licensed to practice medicine in Oklahoma. He is qualified by training and experience to perform the axillary method and to teach the method to other physicians. For approximately 25 years, Dr. Metcalf has limited his medical practice to breast surgery and performs approximately 650 surgeries each year. At the time that Dr. Metcalf taught the accredited seminar in Orlando, his license to practice medicine in Oklahoma was suspended. On November 13, 1995, Dr. Metcalf pled guilty to a felony charge that he violated federal interstate commerce law by selling silicon implants during a moratorium on their sale. The federal court fined Dr. Metcalf $5,000 and sentenced him to six months in federal prison beginning on April 5, 1996. The State of Oklahoma suspended Dr. Metcalf's medical license for one year beginning on the date of his release from prison. The suspension expired on or about October 5, 1997. In May of 1997, Respondent discussed the axillary method with Dr. Metcalf during the seminar in Orlando. Respondent and Dr. Metcalf had known each other since the early 1980s, and Dr. Metcalf agreed to come to the Surgery Center and teach the axillary method to Respondent. Respondent scheduled the teaching session at the Surgery Center for August 12 and 13, 1997. Five of Respondent's patients agreed to participate. The patients are identified in the record as B.D., T.R., R.K., M.P., and D.C. Each patient acknowledged in writing that it would be the first time Respondent would perform the axillary method. Neither Respondent nor Dr. Metcalf charged the patients for a surgeon's fee, and Dr. Metcalf did not charge Respondent. However, the patients paid the costs of the implant, the operating room, and the blood work. Respondent conducted a preoperative interview with each patient. He advised the patient that Dr. Metcalf would be in the operating room teaching Respondent. On August 12 and 13, 1997, Respondent introduced Dr. Metcalf to each patient. Respondent and Dr. Metcalf then scrubbed, gloved, and proceeded with the teaching session. Dr. Metcalf performed approximately 60 to 70 percent of the first surgery. Respondent performed progressively more of each successive surgery until Respondent performed the vast majority of the surgery. The surgery that Dr. Metcalf performed included at least one incision and pocket, insertion of an implant, use of the appropriate surgical instruments, and closure of an incision on at least one patient. Neither Respondent nor Dr. Metcalf caused any harm to a patient. The results of all five procedures were positive and without complication. No patients complained about their treatment. Two of Respondent's former employees are the complaining witnesses in this case. The first issue is whether Dr. Metcalf practiced medicine within the meaning of Section 458.305(3). Section 458.305(3) defines the "practice of medicine" as: [T]he diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition. Dr. Metcalf did not diagnose, treat, or prescribe medicine for any human disease, pain, injury, or deformity, or mental condition. The breast augmentations that he participated in were elective and cosmetic and did not treat any disease, pain, injury, or deformity. Dr. Metcalf must have performed an "operation" for some "other physical . . . condition" in order to practice medicine within the meaning of Section 458.305(3). Respondent's counsel argued during the hearing that the issue of whether Dr. Metcalf practiced medicine was an issue of law, rather than fact. Counsel argued that expert testimony would invade the province of the ALJ. If Respondent's counsel were correct, the result could be problematic for Section 90.702. Although a physician would be qualified by training and experience to opine that a peer's activities satisfy the standard of care applicable to the practice of medicine, the physician would not be qualified to know whether he or his peer practiced medicine. In an abundance of caution, the ALJ requested the parties to cite relevant legal authority in their respective PROs. Neither party cited any direct or analogous legal authority that resolves the issue raised by Respondent's counsel or construes the statutory definition of the practice of medicine in Section 458.305(3). Each party submitted expert testimony concerning the issue of whether Dr. Metcalf practiced medicine. As the trier of fact and arbiter of credibility, the ALJ must resolve the evidential conflicts between the experts. Accordingly, the fact finder has carefully considered the substance of the testimony of the two experts and determined the appropriate weight to be accorded the testimony of each. Respondent's expert based his opinion on a custom within the medical profession in which unlicensed persons, such as members of an emergency medical team, medical students, and first year residents, train under a physician. Respondent's expert opined that an unlicensed person does not practice medicine because the person is learning under the auspices of a physician who has responsibility for the unlicensed person. Respondent's expert relied on facts not in evidence. Unlike the custom described by Respondent's expert, the evidence shows that the person teaching was not licensed to practice medicine in the state where the teaching occurred. The person learning was the only person so licensed. While Respondent had ultimate responsibility, Respondent was not teaching Dr. Metcalf. Dr. Metcalf was teaching Respondent. The custom described by Respondent's expert operates within a framework of laws and rules that are inapposite to this case. Residents who are not licensed to practice medicine in Florida may practice under the supervision of a physician only if the residents, and the hospitals in which they work, comply with registration and reporting requirements in Section 458.345 and Florida Administrative Code Rules 648-6.008 and 6.009. None of those provisions apply to the facts in this case. (All references to rules are to those promulgated in the Florida Administrative Code on the date of this Recommended Order.) Respondent's expert also testified that doctors customarily teach other doctors in states where the teaching doctor is not licensed. In Florida, however, that custom is limited by Section 458.303(1)(b) to activities that satisfy the definition of a consultation. A consultation is defined in Rule 64B8-2.001(8) to include the taking of a medical history, the examination of a patient, the review of laboratory tests and x-rays, and the making of recommendations to a person licensed to practice medicine in Florida. A consultation is not a set of activities separate and apart from the practice of medicine. It is a subset of the "practice of medicine" in Section 458.305(3). The opinion of Respondent's expert is limited, by operation of law, to that part of the practice of medicine that is a consultation within the meaning of Section 458.303(1)(b) and Rule 64B8-2.001(8). That part of the practice of medicine that is not a consultation is the practice of medicine that is at issue in Section 458.331(1)(f). Further references in this Recommended Order to the "practice of medicine" refer to those activities described in Section 458.305(3) that are not a consultation within the meaning of Section 458.303(1)(b) and Rule 64B8-2.001(8). Some of the activities engaged in by Dr. Metcalf at the Surgery Center satisfied the definition of a consultation. Other activities comprised the practice of medicine. The proportion of each is not material in this case. Dr. Metcalf performed at least 60 percent of the first "operation" for some "other physical . . . condition" within the meaning of Section 458.305(3). Dr. Metcalf practiced medicine progressively less with each successive operation and performed progressively more consultation. One purpose of the teaching session was for Dr. Metcalf to first demonstrate the axillary method and then to assist Respondent in the practice of that medicine. As it turned out, this purpose was more qualitative than quantitative because Respondent quickly demonstrated competency. However, if it were unnecessary for Dr. Metcalf to first demonstrate the axillary method, Respondent could have gained the competency he sought by reviewing video tapes, attending seminars, and consulting with Dr. Metcalf. Respondent aided, assisted, procured, or advised Dr. Metcalf to engage in the practice of medicine for at least 60 percent the first surgery performed on August 12, 1997. The next issue is whether Dr. Metcalf was an "unlicensed person" within the meaning of Section 458.331(1)(f). Chapter 458 commonly uses the term "licensed" to refer to persons licensed outside of Florida. For example, Section 458.303(1)(b) refers to physicians "licensed" in another state. Section 458.3115(1) authorizes restricted licenses for "foreign- licensed" persons. Section 458.313(1)(c) authorizes licensure by endorsement for those "licensed" in another jurisdiction, and Section 458.315 authorizes a temporary certificate for persons "licensed" in any other state. Dr. Metcalf was a licensed person in Oklahoma when he practiced medicine at the Surgery Center in August of 1997. A person licensed to practice medicine is not an "unlicensed person" while the person's license is suspended. A contrary finding could be problematic under Florida law. If a person with a suspended Florida license were an unlicensed person during the suspension and the person violated the terms of the suspension, the person would have no professional license against which the Board of Medicine could take further disciplinary action, including revocation of the license. Rather, the Board would be required to seek criminal prosecution pursuant to Section 458.327(1)(a). During the period of suspension, Dr. Metcalf was a licensed person in Oklahoma. However, Dr. Metcalf was not authorized to exercise any privileges under the license or to enjoy the benefits of his license until the suspension expired. Section 458.331(1)(f) does not prohibit Respondent from aiding, assisting, procuring, or advising an unauthorized person to practice medicine. Such a statutory prohibition would have been broad enough to proscribe the practice of medicine by a licensed person whose authority to practice was temporarily suspended. Rather, Section 458.331(1)(f) prohibits Respondent from "aiding, assisting, procuring, or advising any unlicensed person" to practice medicine. (emphasis supplied) Relevant terms in Section 458.331(1)(f) must be construed strictly in favor of the licensee because this is a license disciplinary proceeding that is penal in nature. A finding that Dr. Metcalf was a licensed person in Oklahoma does not resolve the issue of whether Dr. Metcalf was an unlicensed person for the purposes of Section 458.331(1)(f). An "unlicensed person" in Section 458.331(1)(f) is properly defined by reference to Section 458.327(1)(a). Section 458.331(1)(f) prohibits Respondent from "aiding, assisting, procuring, or advising an unlicensed person to practice medicine contrary to this chapter " (emphasis supplied). Section 458.327(1)(a) prohibits the practice of medicine without "a license to practice in Florida." When the term "unlicensed person" in Section 458.331(1)(f) is harmonized with Section 458.327(1)(a), an "unlicensed person" means a person not licensed in Florida. 44. Sections 458.327(1)(a) and 458.331(1)(f) operate in concert. The former proscribes the practice of medicine inside this state without a Florida license. The latter prohibits a person licensed inside the state from assisting in the violation of the former. In August of 1997, Respondent violated Section 458.331(1)(f) by assisting an unlicensed person to practice medicine contrary to Section 458.327(1)(a). Respondent did not intentionally violate Section 458.331(1)(f) and had no prior knowledge of the violation. The cause of the violation is rooted in multiple instances of miscommunication, confusing circumstances, and statutory ambiguity that Respondent did not create. Respondent undertook reasonable efforts to comply with Florida law. Prior to the surgeries, Respondent contacted Ms. Anne Dean. Ms. Dean is the licensed risk manager for the Surgery Center and is qualified by training and experience to advise Respondent in matters of regulatory compliance. Ms. Dean owns and operates a risk management company in Deland, Florida. She is the certified risk manager for over 450 domestic and foreign ambulatory surgery centers. Ms. Dean provides a wide range of services including financial feasibility analysis and the processing of certificates of need. She also provides services to ensure that architectural design, equipment lists, inventories, and policies and procedures comply with applicable state and federal regulatory requirements. Ms. Dean also assists ambulatory surgical centers with other license certification, accreditation, and regulatory matters. Since 1988, Ms. Dean has been the risk manager required under state law for the Surgery Center. Ms. Dean was responsible for the Surgery Center's state licensure and Medicare certification. She has been present during each license and risk management survey conducted by the Agency for Health Care Administration (AHCA). AHCA has never cited the Surgery Center for a violation. Ms. Dean has assisted Respondent in ensuring that renovations to the Surgery Center complied with applicable regulations and, except for the calendar year 2000, has advised Respondent in all matters of regulatory compliance and accreditation. Respondent asked Ms. Dean to ensure that the teaching session to be conducted by Dr. Metcalf complied with applicable state law and any accreditation requirements. Ms. Dean spoke by telephone with unidentified representatives of both AHCA and Petitioner. The advice from those representatives was consistent for two areas of concern. The first area of concern involved the accreditation needed for Respondent to be certified to perform the axillary method. Pursuant to the advice of the agency representatives, Ms. Dean created a surgical proctor report and gave the form to Respondent. After the teaching session, Dr. Metcalf completed a report for each patient and provided the reports to Ms. Dean. Ms. Dean reviewed the reports and met with a three-member committee for the Surgery Center. The committee certified Respondent as qualified to perform the axillary method. The second area of concern involved the status of Dr. Metcalf's license to practice medicine. Respondent was specifically concerned that Dr. Metcalf was not licensed to practice medicine in Florida and that Dr. Metcalf's Oklahoma license was suspended. Respondent requested Ms. Dean to ensure that the teaching session complied with Florida law. Ms. Dean conferred with representatives for Petitioner and AHCA. Ms. Dean advised Respondent that if the person teaching were licensed in another state, the person would be entitled to practice medicine in Florida during the teaching session under the auspices of Respondent, a licensed person in Florida. However, if the person teaching were not licensed in another state, the person could not perform any function that required licensure. Ms. Dean conveyed the advice of the agency representatives to Respondent. The advice from those qualified by training and experience in regulatory compliance is consistent with an educational custom among practitioners. It is common for doctors to practice medicine for educational purposes in states where they are not licensed. Before Respondent began cosmetic surgery, Respondent spent four one-week periods with two different cosmetic surgeons in Texas and Virginia. Respondent was not licensed to practice in Virginia. Respondent obtained similar experience in California where he is not licensed. Respondent is 66 years old and did not attempt to become board certified in plastic surgery. That certification would have required two or three years of general surgery and plastic surgery. Respondent would have spent his time learning complex reconstructive procedures, including cleft lips and pallets, rather than simpler cosmetic surgery. The advice from Ms. Dean and representatives for Petitioner and AHCA was incorrect and based on a mistake of law. The statement that a person licensed in another state can do more than consult in Florida purports to amend or modify the limited authority in Section 458.303(1)(b) as well as the prohibitions in Sections 458.331(1)(f) and 458.327(1)(a). An agency cannot amend, enlarge, or deviate from a statute. The mistake of law arose from ambiguity in Chapter 458. Chapter 458 does not define the term "unlicensed person." An "unlicensed physician" is defined in Rule 64B8-6.001 to mean a medical doctor not licensed by the Board of Medicine. However, the term "unlicensed physician" applies only to Section 458.345 and does not apply to Section 458.331(1)(f). The law implemented in Rule 64B8-6.001 is limited to Section 458.345. The rule refers only to interns, residents, and fellows in a hospital setting. Rule 64B8-6.001 does not define an "unlicensed physician" for any purpose in Chapter 458 except Section 458.345. A broader reading of Rule 64B8-6.001 would conflict with the definition of a "physician" in Section 458.305(4). Section 458.305(4) defines a "physician" to mean a person licensed by the Board of Medicine. The rule defines an "unlicensed physician" as a medical doctor not licensed by the Board. Even if the rule were construed to imply that a medical doctor is not a person, for purposes of Section 458.305(4), the implication would not avoid the apparent oxymoron. Any ambiguity between Section 458.305(4) and Rule 64B8-6.001 must be resolved in a manner that effectuates the statute. Section 458.305(4) defines a physician "as used in this chapter. . . ." (emphasis supplied) Neither the definition of an "unlicensed physician" in Rule 64B8-6.001 nor the definition of a "physician" in Section 458.305(4) defines the term "unlicensed person" in Section 458.331(1)(f). Chapter 458 does not expressly state that a person licensed to practice medicine in another state is an "unlicensed person." Moreover, Chapter 458 uses the term "licensed" interchangeably to mean persons licensed inside and outside of Florida. The correct meaning of the term "unlicensed person" is not found in a single provision in Chapter 458. A licensee must glean the meaning from reading Sections 458.427(1)(a) and 458.331(1)(f) in a manner that harmonizes the two provisions. The following hypothetical further illustrates the unintended ambiguity in Chapter 458. If Dr. Metcalf were licensed in Florida in August of 1997, Section 458.331(1)(f) would not have prohibited Respondent from assisting Dr. Metcalf to practice medicine contrary to Chapter 458, including gross and repeated malpractice. Section 458.331(1)(f) does not prohibit Respondent from helping a licensed person to violate Chapter 458. Statutory ambiguity also exists in the distinction between a consultation and other activities defined as the practice of medicine. Although Chapter 458 recognizes a legal distinction between the two kinds of activity, the practical distinctions evidently ebb and flow on a daily basis through a custom in which practitioners teach others in states where the practitioners are not licensed. The ambiguity in Chapter 458 gave rise to, confusion, mistakes of law by individuals qualified by training and experience in regulatory compliance and miscommunications to Respondent. Respondent reasonably relied on the advice of those qualified by training and experience to advise him in his attempt at regulatory compliance. Respondent did not intend to violate Section 458.331(1)(f). The remaining issue for determination is whether Respondent maintained adequate records for the teaching session at the Surgery Center. The statutory requirement for adequate medical records is set forth in Section 458.331(1)(m). In relevant part, Section 458.331(1)(m) provides that Respondent's license is subject to discipline if Respondent fails: [T]o keep . . . medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering . . . supervising, or billing for each . . . treatment procedure and that justify the course of treatment of the patient. (emphasis supplied) The parties do not dispute that the medical records adequately identify Respondent. The contested issue is whether the medical records justify the course of treatment by adequately identifying Dr. Metcalf by name and title. The medical records include operative reports that identify Respondent by name but do not identify Dr. Metcalf. Petitioner argues that Section 458.331(1)(m) requires the operative reports to identify both Respondent and Dr. Metcalf. Petitioner argues that Respondent was the "licensed physician" and Dr. Metcalf was the "physician extender and supervising physician." Dr. Metcalf was neither the "physician extender" nor the "supervising physician" during the teaching session. Section 458.305(4) defines a physician as a person who is licensed by the Board of Medicine. Dr. Metcalf was not licensed by the Board and was not a physician under Florida law. Respondent was the "licensed physician." Petitioner admits that the medical records adequately identify the "licensed physician" in accordance with Section 458.331(1)(m). If the definition of a physician in Section 458.305(4) were disregarded, the ALJ agrees with Petitioner that Section 458.331(1)(m) implicitly distinguishes a "licensed physician" from a "physician extender and supervising physician." However, the implicit distinction does not serve the ends that Petitioner seeks. Rather, the implicit distinction suggests that the physician extender and supervising physician may be someone other than a licensed physician. If the implied distinction in Section 458.331(1)(m) were correct, it would need to be construed in pari materia with Section 458.331(1)(f) in a manner that gives force and effect to both subsections. The prohibition in Section 458.331(1)(f) could not prohibit Respondent from assisting an unlicensed person who is "physician extender and supervising physician" without nullifying the implied distinction in Section 458.331(1)(m). The interplay between Subsections 458.331(1)(f) and (m) does not alter the outcome of this case. However, it further elucidates the statutory ambiguity that Respondent, his risk manager, and two different agency representatives faced in attempting to ascertain whether the teaching session complied with Florida law. Assuming arguendo that Petitioner's view of Dr. Metcalf as the physician extender and the supervising physician were correct, Petitioner's statutory interpretation conflicts with the literal terms of Section 458.331(1)(m). Section 458.331(1)(m) requires the medical records to identify either the licensed physician or the physician extender and supervising physician. The statute does not require the medical records to identify the licensed physician and the physician extender and supervising physician. Relevant terms in Section 458.331(1)(m) must be construed strictly in favor of the licensee because this is a license disciplinary proceeding that is penal in nature. If it were determined that Dr. Metcalf could be a physician extender without being a physician defined in Section 458.305(4), no statute or rule cited by the parties defines a "physician extender." Although the term may be a term of art within the medical profession, Petitioner failed to adequately explicate that form of art. The evidence was less than clear and convincing that Dr. Metcalf was a physician extender. If it were determined that Dr. Metcalf could be a supervising physician without being a physician defined in Section 458.305(4), the definitions of "direct supervision and control" and "direct responsibility" in Rule 64B8-2.001(1) and (6) and Rule 64B8-4.026(1) aren't probative. The rules merely define the quoted terms by reference to physical proximity. Both Respondent and Dr. Metcalf were physically proximate. The evidence shows that Respondent was ultimately responsible for the surgeries. Respondent had actual control of each surgery, could have stopped each surgery at any time, and was responsible for billing each patient. Unlike the operative reports, the anesthetist reports identify Respondent and Dr. Metcalf by name and title. The parties agree that the anesthetist reports are part of the medical records. Petitioner argues that the identification of Dr. Metcalf solely in the anesthetist reports is inadequate. Petitioner claims the operative reports must also identify Dr. Metcalf. Each party submitted expert testimony concerning the issue of whether the identification of Dr. Metcalf solely in the nurse anesthetist reports was adequate. Petitioner's expert was tendered and accepted "as a physician, in general, and as a plastic surgeon." Respondent's expert practices emergency medicine, rather than cosmetic or plastic surgery, but is an expert in quality assurance. Respondent's expert is better qualified by training and experience, within the meaning of Section 90.702, to assist the trier of fact in a determination of whether the medical records are adequate. The testimony of Respondent's expert is consistent with the record-keeping requirements in Section 458.331(1)(m) and Rule 64B8-9.003. Neither the statute nor the rule requires medical records to identify Dr. Metcalf in multiple parts of the medical records or to identify Dr. Metcalf in any specific document. The anesthetist reports comprise adequate medical records that identify both Respondent and Dr. Metcalf. Petitioner argues that the patient consent forms do not identify Dr. Metcalf; and that Respondent did not tell his patients that Dr. Metcalf would be operating on them or that Dr. Metcalf's license to practice medicine was suspended. No finding is made concerning these issues because they are not relevant to any allegation contained in the Administrative Complaint. The Administrative Complaint does not allege that Respondent failed to obtain informed consent from his patients. If it were determined that Section 458.331(1)(m) requires the operative reports to identify Dr. Metcalf when the anesthetist reports already do so, Respondent did not cause the omission of Dr. Metcalf's name from the operative reports. Respondent instructed his circulating nurse and surgical supervisor (circulating nurse) to identify Dr. Metcalf in the operative reports that Respondent signed but did not read. The regular duties of the circulating nurse included the identification of surgeons in the operative reports. Respondent reasonably relied on the circulating nurse to perform her assigned duties correctly. The Administrative Complaint does not charge Respondent with failure to supervise his employee or with failure to review the operative reports he signed. The circulating nurse failed to identify Dr. Metcalf in the operative reports she prepared for Respondent. Sometime after the teaching session in August of 1997, the circulating nurse abruptly terminated her employment at the Surgery Center following several employment problems. When Respondent hired the circulating nurse in July of 1996, she was in an impaired physician or nurses (IPN) program for treatment of a previous addiction to Xanex and Demerol that she developed during her divorce. However, representatives of the IPN program assured Respondent that the circulating nurse was successfully completing the program. After the circulating nurse terminated her employment, Respondent discovered that drugs were missing from the Surgery Center. Respondent also learned that the circulating nurse had stopped going to the IPN program in August of 1997 and had stopped taking her urine tests. In October, 1997, the IPN program dismissed the circulating nurse. Sometime between August 13 and September 11, 1997, the circulating nurse told Respondent that she suspected the anesthetist of being addicted to drugs because he was falling asleep during surgeries. The circulating nurse also thought some drugs were missing from the Surgery Center. Respondent barred the anesthetist from further surgeries and asked the circulating nurse to conduct a drug count. Respondent left the next day with his wife on a previously scheduled vacation but stayed in communication with the circulating nurse. The circulating nurse conferred with the risk manager and conducted a drug count but did not comply with prescribed procedures. The circulating nurse entered her drug count on a form but did not make any written findings. The circulating nurse told Respondent that she thought some drugs were missing. Respondent requested the circulating nurse to fax him the portion of the Surgery Center manual that prescribed drug audit procedures. The circulating nurse faxed the material and then terminated her employment. When Respondent returned from his vacation, the office keys used by the circulating nurse were in Respondent's mailbox. The circulating nurse quit her job because she felt Respondent expected too much of her. Prior to January 1998, Respondent requested a pharmacy consultant to assist Respondent and his wife in a second narcotic count. The pharmacy consultant confirmed that some drugs were missing from the Surgery Center. The missing drugs included Versed, Demerol, Tylox, and Valium. Respondent reported the missing drugs to the risk manager, and the risk manager reported the incident to the state. The appropriate state agency began an investigation in January of 1998 that included the potential involvement of the anesthetist and the circulating nurse. The anesthetist died shortly after January 1998, and the agency concluded the investigation without charging the circulating nurse. The circulating nurse and Respondent's former insurance secretary are the complaining witnesses in this case. On September 11, 1997, the insurance secretary altered the computer entrees for the employee manual so that the number of hours needed to be eligible for insurance benefits conformed to the number of hours that the insurance secretary worked. Respondent's wife is the office administrator. She discovered the changes and corrected them. She then instructed the insurance secretary not to come into the Surgery Center while Respondent was on vacation. When Respondent and his wife returned from their vacation, they discovered that the insurance secretary had copied all of the patient charts for August 12 and 13, 1997, and had resigned from her job. Neither Respondent nor his wife could locate any of the copied charts. The proctor forms that had been completed by Dr. Metcalf and reviewed by the risk manager and accreditation committee were missing from their files. Whole parts of the surgery manual were missing. The risk manager conducted an independent search for the missing records without success. The risk manager had helped compile the compliance files, was familiar with the records, and would have recognized any misfiled records.
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 Respondent not guilty of violating Subsection 458.331(1)(m), guilty of violating Subsection 458.331(1)(f), and imposing no penalty. DONE AND ENTERED this 3rd day of December, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 3rd day of December, 2002. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 John E. Terrel, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 H. Roger Lutz, Esquire Lutz, Webb & BoBo One Sarasota Tower Two North Tamiami Trail, Fifth Floor Sarasota, Florida 34236
The Issue This proceeding was initiated when HRS proposed to deny San Marco's application for Certificate of Need No. 3304 for an ambulatory surgical center in Jacksonville, Duval County, Florida. San Marco filed a timely petition for formal hearing. Initially four intervenors were involved: Baptist, Memorial, Surgical Services of Jacksonville, Inc. and Medivision of Duval County, Inc. Surgical Services filed its Notice of Voluntary Dismissal on March 7, 1985, and Medivision withdrew on October 28, 1985. At the hearing, San Marco offered evidence through eight witnesses and 28 exhibits; HRS presented one witness and one exhibit; and the two intervenors presented nine witnesses and 26 exhibits. Certain exhibits, by stipulation of the parties, were entered as "Hearing Officer Exhibits." Those four exhibits included the state agency action plan, the petitioner's application for CON, a three-volume state health plan and the District IV health plan The primary issue is whether San Marco is entitled to Certificate of Need No. 3304 for an ambulatory surgical center which will include two operating rooms. During the course of the proceeding several ancillary issues developed; those issues are summarized here and are addressed in the body of this recommended order: In determining need for a free-standing ambulatory surgery center, is it appropriate to consider evidence of out- patient surgical services provided by hospitals? (Petitioner's Motion in Limine, T-9). Is the project proposed by San Marco an "ambulatory surgical center" as defined in subsection 381.493(3)(a), Florida Statutes? (Respondent's Motion to Dismiss, T-500). Should the intervenors, Baptist and Memorial be dismissed for failure to establish standing? (Petitioner's Motion for directed verdict, T-1182). The briefs, memoranda and proposed orders of the parties have been carefully considered in the preparation of this Recommended Order. A specific ruling on each proposed finding of fact is included in the Appendix attached hereto. On March 25, 1986, Petitioner filed a Motion for Restricted Reopening of Record. Basis for the motion is Medivision's withdrawal of its application for certificate of need. The motion is denied.
Findings Of Fact The Parties San Marco is a limited partnership. The owners are Stuart Yachnowitz, individual general partner and sole limited partner; Surgi-Centers of America, Inc., (SCA), a Florida corporation, corporate general partner; and Jacksonville Women's Health Organization, Inc., a Florida corporation, (JWHO), corporate general partner. The sole shareholders of SCA are Stuart Yachnowitz, his father, Joseph Yachnowitz and Susan Hill. The owners of JWHO are Joseph and Stuart Yachnowtiz. (T-47, 48, CON application pp. 20-23). San Marco intends to include local physicians in the ownership of the surgicenter. (CON application p. 40) The surgieenter will be managed by Y and S Management Corporation, the company now providing management services to JWHO. Y and S Management Corporation is owned by Joseph and Stuart Yachnowitz. Including JWHO, it manages eight licensed abortion clinics throughout the country as well as two free-standing ambulatory surgery centers (FSACs) which primarily perform abortions. Susan Hill, the chief operating officer for Y and S for the past ten years, prepared the CON application for the surgicenter. (T-47-49, 108-111). The building at 1561 San Marco Boulevard in Jacksonville, currently occupied by JWHO for its licensed outpatient abortion clinic, will be renovated and occupied by San Marco. The facility will be expanded from approximately 3000 square feet to 4700 square feet. Two operating rooms (ORs) will be added along with ancillary facilities necessary for licensure as an ambulatory surgical center. (Petitioner's Exhibit #1, CON application p. 4, T-52, 54, 55). Abortions will continue to be performed at the facility at an estimated rate of 168 procedures a month. (Petitioner's Exhibit #2, T-102, 103). Other surgical procedures will be added in the categories of gynecology, general surgery, and plastic surgery at the projected rate of 15 per month for the first month of operation to 90 per month after a little over a year's operation. The 90 additional procedures per month is anticipated to continue through the second year of operation. (Petitioner's Exhibit #2, CON application p. 40, T- 102, 103). San Marco anticipates drawing some patients for the additional procedures from its existing caseload and utilizing some physicians who currently practice at the abortion center. (T-62, 63, 101, 102, 247). Memorial is a not-for-profit acute care hospital, located in Duval County in close proximity to the San Marco facility. Since May 1985, Memorial has been providing outpatient surgery services in a dedicated outpatient facility adjacent to the acute care hospital. The same day surgery" facility contains two laser rooms and four operating rooms. (T-854, 913, 914). Baptist is a not-for-profit acute care general hospital also located within close proximity to the San Marco facility. It currently provides outpatient surgical services in twelve ORs and 3 cystoscopy rooms in its main facility. Sometime around August 1987, its new adjacent 17-story structure, The Pavillion, is anticipated to open. The fourth floor of that facility will be dedicated to outpatient surgery and will include four operating rooms and two cystoscopy rooms. (T-939, 984, 987, 988, 1045, 1047). HRS reviewed San Marco's application and determined that it should be denied on the following basis: "There appears to be an insufficient projected number of outpatient procedures to allow this facility to be viable." (State Agency Action Report, September 6, 1984). The State and Local Health Plans The 1985-1987 State Health Plan does not directly address the need for additional ambulatory surgical centers. It adopts as an objective that ". . . By 1989, 30 percent of all surgical operations should be performed on an outpatient basis." (Vol. II p. 81). It addresses ambulatory surgical centers as an alternative delivery system which lowers costs by substituting less costly services. (Vol. II p. 76). And, it outlines a brief history of the increase of ambulatory surgical centers in Florida during the decade of the 1980s. It acknowledges, "As in the case of hospitals, saturation of the marketplace for outpatient surgery has caused new entrants into the field to be more highly specialized in order to attract sufficient business. (Vol. II p. 27). HRS District IV includes Duval, Nassau, Baker, Clay, St. Johns, Flagler and Volusia counties. The 1985 District IV Local Health Plan adopts sub-area boundaries in planning for certain specialized services, including ambulatory surgery. Sub-area A is comprised of Baker, Nassau, Duval, Clay and St. Johns counties. (p. 112). In contrast to the State Health Plan, it makes specific recommendations: that sub-area boundaries should be used for planning purposes; that no additional units should be approved prior to the adoption of state rules; and that no ambulatory surgery units should be added to the district through 1986, when the agency will review the matter again. (p. 20). Utilizing 1983 data to base its projections and the need methodology of a challenged draft state rule, it concludes that Sub-area A has a surplus of 14 ambulatory surgical units. (p 143). Existing Like Facilities and Other Alternatives to the Proposed Service. Ambulatory surgery is typically performed in three types of facilities: general hospitals which mix inpatient and outpatient surgery in main operating rooms; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in adjacent buildings; and free-standing surgical centers which are unassociated physically or administratively with a hospital. (T. 387-390). Testimony in this proceeding was virtually unanimous as to the distinct disadvantages of serving surgical outpatients in a non-dedicated operating room setting. The mingling of' less ill or well outpatients with seriously ill inpatients increases the opportunity for contagion, heightens patient anxiety, deprives patients of access to their families, presents scheduling problems (including the bumping of outpatients in emergencies), and generally increases the cost of the service to the outpatient consumer. (T-386, 388-392, 1125- 1128). Both Baptist and Memorial have recognized the need for separate, dedicated operating rooms. The comparison of hospital-based dedicated ambulatory surgery rooms with free-standing ambulatory surgery rooms stirs somewhat more controversy. There are advantages and disadvantages to both. A hospital-based unit may or may not be more accessible to the physicians. While doctor's offices are often near hospitals, parking still is a problem. While some patients might prefer to avoid a hospital setting altogether, some are comforted by the proximity in the event of an emergency or decision to recuperate overnight. While costs are generally lower in a free-standing facility, there may be an advantage to having the expensive equipment immediately available in some cases (T-241-246, 392, 758-760,996, 1000-1001). If comparing non-dedicated ORs to free-standing ambulatory centers is comparing apples to oranges, then comparing hospital-based ambulatory centers to free-standing ambulatory centers is comparing red apples to green apples. Personal preferences often dictate the choice, but either one will make a pie. There exists no adopted rule governing methodology for determining need for ambulatory surgery centers. In this proceeding, each party presented its own methodology through an expert witness. Those methodologies are described as follows: Petitioner's Need Methodology Howard Fagin, PhD, was qualified as an expert in Health Planning and Health Economics without objection. (T-377) In his opinion there is a need for additional ambulatory surgery rooms. His opinion is based on a four-step process which includes: Analysis of the service area and population within that service area; Review of existing facilities providing comparable or related services; Examination of the utilization of those services within the existing facilities; and Analysis of the need for new health care facilities based upon population and need for new services in the area. 393, 394) Dr. Fagin identified Duval County as the primary service area, and Nassau, Baker, Clay and St. Johns counties as the secondary service area. The surrounding counties depend on Duval for their medical care in many cases. Together, the primary and secondary service areas comprise HRS District IV, Sub- area A (Local Health Plan, p. 112). Population figures are taken from those compiled and projected by the Executive Office of the Governor. (T.-396) For several reasons it is difficult to obtain data on out-patient surgical procedures in Florida. Out-patient surgery is a relatively new phenomenon; some hospitals do not separate in-patient from out-patient procedures in reporting; other hospitals count cases rather than procedures. (T-398) Dr. Fagin felt comfortable with data obtained from the state and from the N. E. Florida Health Planning Council, as adjusted with the use of data obtained from Baptist and Memorial for 1982, 1983, and 1984. (Petitioner's exhibits #11, 12 and 13) For 1984, he figured 31.1 percent of the surgical cases in Duval County were out-patient cases, with the trend increasing. (T-403) Petitioner's Exhibit #15 is the summary of Dr. Fagin's need analysis with two columns, one assuming an out-patient surgery rate of 35 percent of total surgeries, and the other assuming a rate of 40 percent. The number of available ambulatory surgery rooms (24) is based upon the availability of four rooms in one recently opened free-standing ambulatory center (AMI) and twenty other free-standing or dedicated (used only for out-patients) operating rooms in Duval County hospitals. The analysis assumes that the rooms will be operated five days a week, two hundred and fifty days a year (5 days x 52 weeks, minus 10 days for holidays and "down-time"). The figure of 960 cases per year, per room, is further derived from the assumptions the room will be operated 6 hours a day, an average case (including preparation, surgery, and cleanup) will take 1.25 hours, and the rooms will be utilized 80 percent of the time. In addition to the number of cases described to dedicated and free-standing rooms through that process, 3000 cases are presumed to be done each year in non-dedicated operating rooms. This figure is derived from rounding off the reported 3030 out-patient cases in non-dedicated units in 1983. The rationale for including those cases is that due to lack of sufficient free-standing units, the out-patient services must be provided in the regular hospital OR environment. The number of such cases, according to Dr. Fagin, should decrease as the number of free-standing units increases. (T. 414-415). Dr. Fagin's methodology applied to various hypothetical fact situations yields the following conclusions as to need for (+), or excess of (- ), free-standing ambulatory surgery operating rooms: Assuming a service area including all of HRS District IV, Sub-area A, 24 currently available rooms; and 960 cases per room per year: (Petitioner's Exhibit #15) 35 percent 40 percent + 6 rooms + 10 rooms Same assumptions as A, above: (intervenor`s Exhibit #16) 30 percent rate + 1 room Same assumptions as A, above, except limited to Duval County: (Intervenor Exhibit #17) 30 percent 35 percent 40 percent -4 rooms -1 room +2 rooms Same assumptions as A, above, except 31 existing rooms, instead of 24: (Intervenor Exhibit #18) 30 percent 35 percent 40 percent not calculated -2 rooms +3 rooms Same assumptions as A, above, except 31 existing rooms and service area limited to Duval County: (Intervenor Exhibit #19) 30 percent 35 percent 40 percent -11 rooms -8 rooms -5 rooms Same assumptions as A., above, except 1200 cases per room per year, instead of 960: (Intervenor Exhibit #20) 30 percent 35 percent 40 percent -4 rooms -1 room +3 rooms Same assumptions as A, above, except 1200 cases per room and 31 existing available rooms: (Intervenor Exhibit #21) 30 percent 35 percent 40 percent -11 rooms -8 rooms -4 rooms Same assumptions as A, above, except 1200 cases per room, 31 existing available rooms and Duval County only: (Intervenor Exhibit #22) 30 percent 35 percent 40 percent -15 rooms -13 rooms -10 rooms HRS Need Methodoloy Reid Jaffe, Medical Facilities Consultant for the Office of Community Medical Facilities, was qualified as an expert in health care planning with emphasis on certificate of need. (T-533) He explained the ambulatory surgical center need methodology as summarized in DHRS Exhibit #1. The Department typically uses a single county as its planning area for ambulatory surgery applications. (T-556). Therefore, the data is based on Duval County population and services provided by Duval County facilities. To obtain the volume of surgical procedures in Duval County hospitals, letters were written requesting the break-out for the period February 1984-January 1985. While the process is not an exact science, Mr. Jaffe feels that since the Department asks for the same type of information over a period of time, the anomalies in the figures will become obvious. (T-569). Based upon the returns to the questionnaire, the Duval total surgery rate, (out-patient and in-patient) was determined as 97.7 per 1000 population; the out- patient surgery rate was determined to be 30.2 per 1000 population. The July, 1987 population projection was 623,091. Need was projected at both 30 percent out-patient to total surgeries and 40 percent out-patient to total surgeries. The out-patient surgical potential (number of procedures) is derived from subtracting the hospital out-patient surgical volume from the projected number of procedures needed at a 30 percent and 40 percent rate. From that line was deducted the projected breakeven procedures for each of three free-standing ambulatory surgery centers in various stages of development in Duval County. The 30 percent rate yielded a bottom line of 5,922 excess procedures, and the 40 percent rate yielded a bottom line of 165 procedures remaining for some other facility to perform (unmet need). Since HRS considers the facility breakeven point to be considerably more than 165 procedures per year, it concludes that no additional facilities are required at this time. HRS did not explain its assumption that the rate of surgeries performed on an out-patient basis at hospitals would remain constant (30.2 per 1,000 population), while the overall percentage of out-patient surgeries to total surgeries would increase to 40 percent. (DHRS #1, T-569-576). Intervenor's Need Methodology Michael Swartz testified for Memorial and Baptist as an expert in health care planning and hospital administration. (T-704) He rejected the second-hand data utilized by both Petitioners' and HRS' experts. He devised a poll that was sent to all area hospitals and attempted to verify the responses through direct contacts and, in some instances, a walk-through of the facilities and review of hospital records. Information reported in State Agency Action reports was used for St. Luke's, since that one hospital failed to respond. (T- 704-707, 711-713). Like the other need methodology experts in this proceeding, Mr. Swartz relied on population projections from the Executive Office of the Governor. (T- 711). The geographical service area was considered Duval County, because that is what the state considers and in Mr. Swartz' opinion an ambulatory surgery center draws from a less than 30-minute driving period. (T-712). Mr. Swartz found in his data gathering that, while the number of surgeries per 1000 population has fluctuated only slightly, the mix of surgeries (in-patient to out-patient) has shown a dramatic increase in out-patient procedures. (Intervenor's Exhibit #5, T-722). After determining what he considered were the actual numbers of surgeries performed in 1983 and 1984, the actual number of operating rooms in Duval County, and the actual amount of time spent for each case, including clean-up, he determined that the bottom line showed a utilization rate of only 27.8 percent of existing surgical suites in Duval County in 1984. (Intervenor's Exhibit #6, T-729). Utilizing a fixed use rate of 103.3 surgery cases per thousand, Mr. Swartz projected an excess capacity of 109,214 cases in hospitals in 1986 and 1987, and an excess capacity for 19,279 cases in free-standing surgical centers (including AMI, Surgicare III and Medivision) in 1986 and 1987. (Intervenor's Exhibit #12 and #14, T-749, 750). The most fatal flaw in Mr. Swartz' ultimate conclusion, that there is a current and projected excess of surgery suites in Duval County, is that after his painstaking data-gathering process he lumped together all types of existing operating rooms and assumed they were all equally appropriate to handle in- patient and out-patient surgeries. This assumption is contrary to the weight of evidence in this proceeding. Of the three methodologies presented, I find Dr. Fagins most reasonable. It requires some adjustments, however, to conform to the evidence. Proceeding from Petitioner's Exhibit #15, I find the 40 percent out-patient surgery rate reasonable and consistent with credible expert testimony from all sides in this case. (Howard Fagin - T-413; Reid Jaffe - T-573; Rena Blackmer - T-106l; Carol Whittaker-T- 990: Eileen Fullernveider, T- 1125). Utilization of Subdistrict A as the service area is also 4 appropriate here. It is consistent with the District IV local health plan and recognizes the fact that Jacksonville draws from outlying counties for the sophisticated range of medical services it provides. (T-254, 255) while ordinarily free-standing surgery centers might be more neighborhood oriented and draw from a closer geographical area, it is noted that Duval is the only county in Subdistrict A with free-standing or dedicated operating rooms and for that reason patients could be expected to travel into Jacksonville. (Petitioner's Exhibit #14) The one-hour travel time addressed in the CON application, p. 226, would include some travel from the outlying counties. Reid Jaffe, the HRS expert, does not agree with the local health plan because it would be unlikely that a resident of a county that has a hospital or multiple hospitals in it and that have ambulatory surgical programs, to bypass those closer facilities just to go to Jacksonville." (T-554, 555). In the absence of dedicated ambulatory surgical programs, however, some patients very likely would travel to Jacksonville. The continued projection of 3000 cases in non-dedicated operating rooms is reasonable, since not all ambulatory surgery patients would travel to Jacksonville. Further, even when it completes its new ambulatory center, Baptist anticipates continuing to conduct approximately 2096 of its out-patient surgeries in the main ORs. (T-1063, 1064, 1085). Patient and physician loyalty would also account for some continued out-patient surgeries in those hospitals without dedicated ORs. The population projection for 1988 is appropriate, given a two-year planning horizon and the fact that the final hearing in this proceeding was continued until the end of 1985. The surgical rate of 102.94 per 1000 population is slightly higher than the 97.7 rate utilized by HRS but, just under the 103.3 rate utilized by Intervenor's expert, Howard Swartz. (Intervenor's Exhibit #14). Petitioner's Exhibit #15 understates the available ambulatory surgery rooms projected for 1988. A second free- standing ambulatory surgery center has been approved for Jacksonville and has completed its legal proceedings: Surgicare III, with 3 operating rooms. (T-562, Surgical Services of Jacksonville v. HRS, 479 So.2d 120, Affirmed 11/18/85). The record in this proceeding does not clearly reveal the status of a third surgical center, Medivision, with two rooms dedicated to opthomologieal surgery. Since that facility may still be in legal limbo, its rooms are not being counted. While Intervenor, Baptist, on cross examination posited a hypothetical application of Petitioner's methodology which included seven additional available rooms, no competent evidence followed up to substantiate any more than three additional beds. The available ambulatory surgery rooms factor in the methodology is therefore adjusted to 27. Petitioner's methodology also understates "available capacity" by understating the number of cases which could be handled per room, per year. While Dr. Fagin's methodology utilized 960 cases per room, per year, the weight of evidence and expert opinion established that at least 1300 cases per room, per year is a more realistic approximation. Intervenor's need expert, Michael Swartz, determined capacity based on ten available hours per day, five days a week, at 75 percent effici-ency (American College of Surgeons Standard) to be 2,077 cases per room, per year. (Intervenor's Exhibit #9, T-735- 737). The Hill-Burton standard utilized to determine the need for construction funds in the 1970's was 1200 cases per year, based upon data collected in the 1960s when the average time for a ease was 2 hours. (T-740, 741). Average time today is far less. (T-149, 240, 1064) Petitioner's own projected utilization assumes a capacity for 2 operating rooms, with evening and Saturday scheduling to be 300 procedures a month. (Petitioner's Exhibit #2). This translates into 1800 procedures per year, per-room. while recognizing that counting procedures rather than cases yields a higher number, San Marco never asserted that it anticipates performing two procedures for almost every case it handles. Yet this ratio is the only means of reconciling the difference between its expert's projection and that of its administrator. The above-described adjustment to Petitioner's need methodology results in the following adaptation of Petitioner's Exhibit #15: 40 percent Am. Surg. Subdistrict A 1988 Population Surgical Rate Total Surgery 861,120 102.94/1000 pop. 88,644 Ambulatory Surgery 35,457 Available Am. Surg. rooms 27 Available capacity (1300 cases) 35,100 Am. Surg. in Hospitals 3,000 Net Need Cases -2,643 Net Need Rooms - 2 Quality Of Care San Marco will occupy a building presently occupied by the Jacksonville Women's Health Organization, a licensed abortion clinic. If the certificate of need is granted, the existing building will be remodeled to provide two operating rooms and ancillary facilities required for licensure as an ambulatory surgical facility. HRS witness Reid Jaffe does not question the ability of the structure to meet requirements for licensure and does not question the ability of the proposed center to provide quality care. (T-584). The center will develop bylaws and protocols to maintain quality of care. To practice at the center, a physician must be licensed in Florida and must have privileges in good standing at a local hospital (T-59, 60). Jaroslav Fabian Hulke, M.D., was accepted as an expert in obstetrics and gynecology. He has had extensive experience in teaching and conducting out- patient surgery. (Petitioner's Exhibit #7). He has become personally familiar with Y & S Management's facilities and with their staff through his work at the center in Raleigh, North Carolina. He has also observed the facility in Jacksonville and assisted Susan Hill in developing the equipment list for the facilities. His high commendation of Miss Hill, her facilities and the planned equipment was without equivocation; his testimony as to the anticipated quality of care to be offered by this facility is most credible. (T-351, 353, 355). Anesthesia classifications range from I to IV depending on the condition of the patient. Class I and II are relatively healthy. The San Marco center will handle class I and II; some hospital out-patient units handle class III patients on a selected basis. (T-114, 141, 1120). Statistics on emergencies and deaths in free-standing ambulatory centers are not available now. The Free-standing Ambulatory Surgical Association (FASA) is in the process of gathering data. (T-1129, 1153, 1154). Depending on how they are run, equipped and staffed, the free-standing centers are considered extremely safe. (T-1128). Nothing in this proceeding would hint that the proposed administration, staffing or equipment for San Marco is less than high quality. Staffing By their Prehearing Stipulation filed on October 25, 1985, the parties agreed that there exists in Duval County an adequate labor pool of health manpower and management personnel to staff an ambulatory surgical facility. San Marco has the ability, experience and intention to obtain adequate, well- trained personnel to provide staffing for the proposed center. (T-72-75, 232- 236, 351-352). Physical and Economic Accessibility The parties have stipulated that the proposed facility is geographically available to all residents of Duval County. (Prehearing Stipulation, filed October 25, 1985). While the center will focus on the Duval County area, it also will likely draw from surrounding counties to a lesser degree. The existing abortion center already serves the wider area and as found in paragraph 12 above, no free-standing ambulatory center or dedicated out- patient ORs exist in Subdistrict A outside Duval County. For that reason, patients could be expected to drive as much as an hour to get to the facility. (CON application, p. 226). San Marco claims that it will serve 15 percent medicaid and 5 percent medicare patients. (CON application pp. 91-136). The Raleigh-Surgi-Center was used as a model since it is the one facility that receives medicaid reimbursement for non-abortion procedures. (T-89,160). However, while Medicaid does not reimburse for abortions, the State of North Carolina provides state funds and apparently those patients are computed in Raleigh's 21.6 percent figure. (T-89,90). The validity of the model is undermined by the fact that no such reimbursement occurs in Florida. (T-161). Even though the 20 percent Medicaid and Medicare projection is overstated, economic accessibility is enhanced by the willingness of the center to reduce fees for abortion procedures for otherwise Medicaid eligible patients by $50.00 or $60.00, which sum represents the management fee portion of the procedure cost. (T-158-160). More significantly, the projected standard fee for other than abortion procedures, $300.00 - 400.00, is substantially lower than fees at hospitals, including hospitals with separate ambulatory units. (T- 57, 81-82, 907, 1070, 1071, Petitioner's Exhibits #19, 20, 21, 22). Capital Costs and Financial Feasibility The total anticipated project cost for the proposed center is $246,000.00, including $80,000.00 for renovation of the building and approximately $133,000.00 for the purchase of equipment. (T-94-98, 172-173, 327). Capital is available for project start-up through the personal funds of millionaires, Stuart and Joseph Yachnowitz. (T-172). In its review of the application, HRS concluded: "There appears to be an insufficient projected number of out- patient procedures to allow this facility to be viable." (State Agency Action Report, Hearing Officer Exhibit #1). At hearing, HRS witness Reid Jaffe testified that because of the co-mingling of revenues from the abortion center and the proposed ambulatory surgery center, the financial feasibility of the project could not be determined. (T. 588, 589). On the other hand, if the revenues are co-mingled and if the projections in the applicant's pro formas are accurate, then the facility ought to do better than break even. (T-600-601). Christopher Fogel, Petitioner's expert accountant, represents Y & S Management and the ten out-patient facilities owned by Joseph and Stuart Yachnowitz. (T-182, 183) His financial projections for the proposed facility are found in Petitioner's Exhibits #5 and #6. The first projection is based upon the fee of $300.00 per procedure, for one hour of OR time, and the second is based upon $400.00, for 1.3 hours of OR time. The projections presume the facility would continue to offer its existing services (abortions) at its current level and expand to 250, 500 or 1000 procedures per year. At the $300.00 per procedure level, the facility would begin to make money with 500 additional procedures a year. However, by adding back 50 percent of the management fees (profit in the fees available to the Yachnowitz') and adding back depreciation and amortization, a positive cash flow results without any additional procedures, and increases substantially for 250, 500 and 1000 procedures at both the $300.00 and $400.00 per procedure rate. (T-198-206). Given the worst case scenario (no additional procedures), the owners are losing money only for tax purposes, but are actually increasing cash flow through the legitimate tax deduction of a loss which is not a loss of cash. (T-206). H. Impact on Competition The introduction of a free-standing ambulatory center in Duval County had a positive dynamic effect on existing traditional providers of surgical care in Duval County. Prices were lowered and more hospitals began out-patient surgery programs of their own. While the changes in costs and methods of surgical services is also attributable to pressure and incentives from insurers, no one disputes that the competition from AMI (the one free-standing facility in Duval County that is currently operational) was healthy. (T-639, 640, 1132, 893-894, 1061, 996- 997, 239). HRS health care planning expert, Reid Jaffe is of the opinion that currently the four ORs at AMI, the two opthalomological ORs at Medivision, and the 3 general ORs of Surgicare III (approved but not yet opened) are sufficient competition to the hospitals and to each other (T-564- 565, 643). No one seriously contends that the addition of San Marco's 2 ORs would put an existing facility out of business. Memorial's Chief Financial Officer, Earl Winston Lloyd, expects his facility's new out-patient unit to continue to be profitable with or without San Marco. Memorial's out-patient facility has exceeded Memorial's expectations in its productivity and profitability (T. 871- 874). John Anderson, Chief Financial Officer at Baptist, is concerned that Baptist will lose at least 35 procedures per month which are currently being performed at Baptist by physicians who have indicated an interest in practicing at San Marco. (Intervenor's Exhibit #23, T-943-945). However, he doesn't know whether those same doctors are performing out-patient surgeries in other facilities or whether those surgeries might be the ones that are taken to San Marco. (T-976). Rena Blackmer, Director of Surgical Services at Baptist, testified that when competing out-patient units opened at A.M.I., Memorial and St. Lukes, she felt initially that Baptist was losing a share of the market, but there has not been a continuing adverse effect. (T-1062). In 1985, Memorial`s excess revenue over expenses was approximately $2.5 million, with gross patient revenues of $80-82 million. (T. 863, 864). In 1985, excess revenue over expenses for Baptist was approximately $10 million. A $4.6 million loss on refinancing a debt is not included in that total; however, the $4.6 million is a balance sheet entry which impacts the income statement and is not a cash item. (T-956, 957) Total operating revenue in 1985 was $96 million. (T-955) David Mobley M.D. is a plastic surgeon who has been medical director of the Jacksonville Womens Health Organization since 1976. He practices at Baptist Medical Center, and his name appears on Intervenor's Exhibit #23 as one of the doctors whose out-patient surgeries the hospital is concerned about losing to San Marco. Dr. Mobley performs in his private office approximately ten surgeries a week that he would like to transfer to San Marco. Among as those cases are performed in his office, he is reimbursed only the fee that he receives for the same procedure done in a hospital. He absorbs the cost for his operating room at his office, his staff and supplies. (T- 247, 248). For the patient or his insurer however, the cost for the procedure would be at least twice as much in a free-standing surgery center as in the physician's office. (T-268). San Marco: Abortion Clinic or Ambulatory Surgical Center? From all the evidence in this proceeding the uncontrovertible fact emerges that when and if it is approved, San Marco Surgi-Center will merge with the Jacksonville Women's Health Organization and the two entities will make up a single health care facility: the building is the same; the equipment is the same; the owners are primarily the same; the managers are the same; and for purposes of predicting financial success, the revenue and expenses of the two entities have been considered one and the same. San Marco projects that even after two years of operation as a surgical center, a majority of its procedures will remain abortions. (Petitioner's Exhibit #2). Abortions are accomplished in health care facilities through a variety of surgical techniques, the most common of which is dilation and evacuation (D & E). (T-346, 347). Even though D & E's are expected to predominate at the facility in terms of projected number of procedures (168 per month, compared to 90 other surgical procedures per month, by June 1988), the D & E's will not predominate either in gross revenue from fees or in the anticipated OR time. San Marco anticipates the average patient charge for surgeries other than abortions to be $400.00 per case and the average OR time to be 1.3 hours. (T-93, 149). The non-medicaid patient charge for a D & E is $185.00, and the time in the OR room is generally about twenty minutes. (T-148, 158). Taking the same month, June 1988, and multiplying the number of abortions first by fee, then by OR time, yields a total of $31,080 in fees and 55.4 hours in the OR room. The same process for the 90 other surgical procedures yields $36,000.00 in fees and 119.7 hours OR time.
Recommendation Based on the foregoing, it is recommended that Certificate of Need #3304 be denied. DONE and ORDERED this 2nd day of April, 1986, in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of April, 1986. APPENDIX TO RECOMMENDED ORDER, CASE NO. 84-3712 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in substance in paragraph 3. Adopted in paragraph 1. Adopted in substance in paragraph 2. The surgical procedures are summarized by category in paragraph 3. Adopted in substance in paragraphs 2, 16 and 24. Rejected as cumulative and unnecessary. Adopted in substance in paragraphs 16 and 19. Adopted in substance in paragraphs 25 and 26. The statement of John Anderson's testimony is unnecessary, Rejected as cumulative and unnecessary. Adopted in substance in paragraph 26. Rejected as cumulative and unnecessary. Substantially adopted as summarized in paragraph 26. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in substance in paragraph 12 and 21. Adopted in substance in paragraph 12, 13 and 21. Adopted in substance in paragraph 13. Adopted in substance in paragraph 13. Adopted in substance in paragraph 4. Adopted in substance in paragraph 5. Adopted in part in paragraph 5, otherwise rejected as unnecessary. Rejected as irrelevant and unnecessary. Adopted in paragraph 20. Rejected as irrelevant. Rejected as explained in paragraph 22. Rejected as unnecessary. Policy memorandum #7 is addressed in Conclusion of Law No. 3; otherwise this is rejected as a finding of fact. Rejected as unnecessary. Rejected as repetitive. Adopted in substance in paragraph 24 and 26. Adopted in substance in paragraph 21. Adopted in paragraph 9. Rejected as cumulative. Adopted in paragraph 9, otherwise rejected as contrary to the weight of evidence or unnecessary. Adopted in part in paragraph 29, otherwise rejected as unnecessary. Adopted in substance in paragraph 28. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in substance in paragraph 28. Adopted in paragraph 28. Adopted in part in paragraph 28, otherwise rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in paragraph 29 as to the profit of $10 million dollars, otherwise rejected as unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. As addressed in conclusions of law #10 and #11, the impact on Baptist was found to be minimal and insufficient to support "standing". Adopted in paragraph 10. Rejected as unnecessary. Rejected as unnecessary. Adopted in substance in paragraphs 10 and 11. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in substance in paragraph 11. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary, except as to the apples/oranges analogy, which is adopted in paragraph 9. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in paragraph 11. Adopted in paragraph 10, as to the characterization of Dr. Fagin's testimony. Otherwise, rejected as summary of testimony rather than findings of fact. The adoption of 40 percent as reasonable is found in paragraph 12. Rejected as contrary to the weight of the evidence. HRS Need Methodology is rejected in paragraph 10.(b) and paragraph 12 as being less reasonable than Petitioners' experts methodology. Rejected as essentially argument, rather than findings of fact. Rejected as contrary to the weight of evidence. Rejected as repetitive. Adopted in substance in paragraph 33 and Conclusion of Law #3. Rejected as argument unsupported by the weight of evidence. Rejected. See paragraph 7 for discussion of State Health Plan. Rejected as argument, rather than finding of fact. No paragraph of this number is found in Petitioner's Proposed Findings of Fact. Adopted in Conclusions of Law, paragraph 4. Rulings on Joint Proposed Findings of Fact Submitted by the Respondent and Intervenors. (Note, the numbers in the left column conform to the numbering of the joint proposed findings) 1. Adopted in substance in paragraph 1, 2 and 3. Adopted in paragraph 6. Adopted -In paragraph 4. Adopted in paragraph 5. 1. Adopted in paragraph 7. Adopted in paragraph 8. Rejected as irrelevant. Adopted in part in paragraph 8, otherwise rejected as unnecessary. Rejected as irrelevant. Adopted in substance in paragraph 10(b). Rejected as contrary to the weight of the evidence. Adopted in part in paragraph 10, otherwise rejected as unnecessary. Rejected as a re-statement of testimony, rather than finding of fact 10.c. Description of Mr. Swartz' methodology is provided in paragraph Rejected as irrelevant. Rejected as irrelevant. 13 - 21. Rejected as unnecessary. Adopted in substance in paragraph 10. Rejected as unnecessary. Rejected as contrary to the weight of evidence, except as reflected in paragraph 10. Adopted in part in paragraph 10.b., otherwise rejected as unnecessary. 25A. Adopted in part in paragraph 10, otherwise rejected as unsubstantiated by competent substantial evidence. Adopted in part in paragraph 10, otherwise rejected as unnecessary. Adopted in part in paragraph 22 and 23, otherwise rejected as unnecessary. 1. Adopted in substance in paragraph 31. Adopted in substance in paragraph 31. Rejected as contrary to the evidence by considering all uncontroverted testimony and evidence describing the facility. Adopted in part in paragraph 32 and 33, otherwise rejected as irrelevant. Adopted in part in paragraph 32 and 33, otherwise rejected as irrelevant. Rejected as contrary to the weight of the evidence. Adopted in part in paragraph 31, 32 and 33, otherwise rejected as irrelevant. Rejected as irrelevant. Rejected as contrary to the weight of the evidence. 1. Rejected as unnecessary. Rejected as argument that is unnecessary or unsupported by competent substantial evidence. Adopted in substance in paragraph 27. 1. Rejected as cumulative. Rejected as cumulative. Rejected as unnecessary. Adopted in part in paragraph 4, 5 and 10, otherwise, rejected as unnecessary. Adopted in substance in paragraph 9. Adopted in substance in paragraph 9. Adopted in part in paragraph 4 and 5, otherwise rejected as unnecessary. Rejected as cumulative. Addressed in Conclusion of Law 6. 1. Adopted in paragraph 17. Rejected as irrelevant. Rejected as irrelevant. 1. Rejected as cumulative. 2. Rejected as mere re-statement of testimony rather than a finding of fact. 1. 1. 1. 1. Adopted in paragraph 20. Adopted in part in paragraph 24, otherwise rejected as irrelevant or contrary to the weight of evidence. Rejected as irrelevant. 1. Adopted in part in paragraph 26, otherwise rejected as irrelevant. Adopted in paragraph 24. Rejected as irrelevant. 1. Addressed in Conclusion of Law 4. 1. Addressed in Conclusion of Law 4. 1. Rejected as unnecessary argument. Adopted in part in paragraph 27, otherwise rejected as unnecessary. Rejected as the description of an exhibit and characterization of testimony. Adopted in part in paragraph 30, otherwise rejected as unnecessary. 1. Adopted in paragraph 24. COPIES FURNISHED: William J. Page, Jr., Secretary Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32301 Steve Huss, Esquire General Counsel Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32301 Chris H. Bentley, Esquire William E. Williams, Esquire Jeannette Andrews, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Richard Power, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 Michael J. Dewberry, Esquire Christopher Hazelip, Esquire 1300 Gulf Life Drive Jacksonville, Florida 32207 Robert Meek, Esquire Post Office Box 240 Jacksonville, Florida 32201 =================================================================
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.
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 issue in this case is whether Petitioner's application for a license by endorsement to practice medicine in the State of Florida should be granted or denied.
Findings Of Fact Petitioner is a medical doctor. Petitioner graduated medical school from the University of Miami in Miami, Florida, in May 1994. Petitioner signed an application for medical licensure by endorsement with the Board on January 9, 2003. On or about January 16, 2003, the Department of Health received Petitioner’s application for medical licensure by endorsement. Following receipt and review of the subject application, Petitioner was required to provide some additional information to the Board. Petitioner was eventually required to appear before the Credentials Committee of the Board to answer questions about his application. On October 17, 2003, the Board issued a Notice of Intent to Deny Licensure, in which the Board notified Petitioner of its intent to deny his application. That notice read as follows, in pertinent part: This matter came before the Credentials Committee of the Florida Board of Medicine at a duly-noticed public meeting on September 13, 2003 in Tampa, Florida[,] and the full Board on October 3-4, 2003, in Ft. Lauderdale, Florida. The applicant appeared before the Credentials Committee on September 13, 2003, and presented testimony regarding the application file. The application file shows: The applicant lied before the Committee and lied on the licensure application as to the following: the applicant took a leave of absence during his training; the applicant was placed on probation at 3 schools; the applicant did not finish his training in the normal time frame; and, the applicant answered #15 b, c, d and #31 incorrectly on the application. The applicant is guilty of violating Section 458.331(1)(gg), Florida Statutes, for misrepresenting or concealing multiple material facts at any time during any phase of a licensing or disciplinary process or procedure. Based on the foregoing, the Board may refuse to certify an applicant for licensure, or restrict the practice of the licensee, or impose a penalty, pursuant to Sections 458.3331(2) and 456.072(2), Florida Statutes. It is therefore ORDERED that the application for licensure be DENIED. Petitioner attended the following four postgraduate training programs (residency programs): Medical College of Pennsylvania; Sinai Hospital1; Wayne State University/Detroit Medical Center; and University of Medicine and Dentistry of New Jersey (“UMDNJ”). Petitioner’s dates of attendance in those four residency programs were as follows: Medical College of Pennsylvania from July 1, 1994 to June 30, 1995. Sinai Hospital from July 1, 1995 to June 30, 1999. Wayne State University/Detroit Medical from July 1, 1999 to June 30, 2001. UMDNJ from July 1, 2001 to June 30, 2003. Question number 15a on the application for medical licensure by endorsement asks, “Have you ever been dropped, suspended, placed on probation, expelled or requested to resign from a postgraduate training program?” Petitioner answered “yes” to question number 15a and submitted a written supplemental answer which stated, “I was placed on probation regarding the expectations of running a University service in a manner that kept attending physicians informed of patients’ clinical changes in July of 2000. Specific goals were given to me that I immediately fulfilled and was taken off probation in September of 2000 and remained in good academic standing until the time of my graduation.” On his application for licensure, Petitioner only admitted to being on probation at one residency program, Wayne State University/Detroit Medical Center. During the processing of the subject application, an employee of the Department of Health, Wendy Alls, advised Petitioner as follows by e-mail: “We are in receipt of your response to the inquiry from Wayne State University [Sinai Hospital], regarding your Residency from 7/95 to 6/99. It indicates that you were placed on probation and received negative reports. It also stated that limitations were placed upon you due to academic incompetence. Please respond.” On May 6, 2003, Petitioner submitted an e-mail response to Wendy Alls regarding his probation at Wayne State University [Sinai Hospital] which stated: “It is true that I did receive negative reports during my residency training from 7/95 to 6/99 for my work ethic. However, I was never formally placed on probation as per the guidelines of the Wayne State University. I, as well as the Graduate Medical Education Office, must receive formal written notification identifying the areas of deficiency and the duration of the probation period. Written notification must be submitted to both the GME office and myself after successful completion of the probation period. This was never done. In addition, no limitations or restriction were ever placed upon me due to academic incompetence or for any other reason for that matter.” Petitioner did not admit this on his initial application to the Florida Board of Medicine. Sinai Hospital submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital submitted a report to the Federation Credentials Verification Service (“FCVS”)2 and stated on the report that Petitioner was on academic probation during his residency from 1996 to 1997. Sinai Hospital reported that Petitioner was placed on probation during his residency in response to faculty concerns regarding both academics and behavior. While at Sinai Hospital, Petitioner was informed of the issues he needed to improve during his probationary period. These issues included, but are not limited to the following: Petitioner’s tardiness, sleeping during conferences, unavailability when on call, failing to follow hierarchy, and inability to carry his share of the workload. Petitioner admitted at the formal hearing he was told that he was on probation at Sinai Hospital. During his appearance before the Credentials Committee on September 13, 2003, Petitioner testified under oath, that he did not disclose the fact he was on probation at Sinai Hospital because he was never informed that he “was ever placed on probation.” A letter dated November 4, 1999, from Dr. Andrew Saxe (who was then the general surgery residency program director at Sinai Hospital) states that Petitioner was on “probationary status” at Sinai Hospital during his residency from 1996 to 1997. Dr. Andrew Saxe also noted Petitioner’s probationary status in a memo dated April 28, 1999, which Petitioner himself signed. Petitioner signed a memo dated December 18, 1996, stating that he was on “probationary status” at Sinai Hospital during his residency. Petitioner also signed a memo dated April 16, 1997, stating that he was “off probationary status” at Sinai Hospital during his residency. Wayne State University/Detroit Medical Center submitted a Training Evaluation Form to the Board and stated on the form that Petitioner was on academic probation during his residency from 1999 to 2000. Petitioner failed to fully disclose all of the reasons why he was placed on probation at Wayne State University/Detroit Medical Center. Wayne State University/Detroit Medical Center submitted a report to the FCVS and stated on the report that Petitioner was on academic probation during his residency for four months beginning in September 2000. The report stated that the probation was based on evaluations which cited “inadequate performances in clinical application of knowledge especially recognitions of own capabilities and limitations. There were also concerns over attention to details and work habits.” Petitioner’s supplemental answer to question 15a does not fully disclose his deficiencies in clinical knowledge and work habits at Wayne State University/Detroit Medical Center. At all times material to this case, Dr. Mark Granick has been the director of the plastic surgery program at UMDNJ. UMDNJ submitted a Training Evaluation Form to the Florida Board of Medicine and stated on the form that Petitioner was on academic probation during his residency “due to poor in-service exam scores.” After UMDNJ submitted the Training Evaluation Form, Petitioner contacted Dr. Mark Granick to discuss his probation at UMDNJ and the “program’s specifications in defining probation.” Dr. Mark Granick was prompted to send a second Training Evaluation Form to the Board, changing the substance of the first submitted Training Evaluation Form. The second Training Evaluation Form to the Board was submitted along with a letter from Dr. Mark Granick dated February 14, 2003, which stated he made an error in filling out the original form. When Dr. Mark Granick drafted Petitioner’s Fourth- Quarter Report on May 31, 2002, he was “documenting the reasons why I wanted him on a period of supervision, which I thought of as probation at that point in time.” Petitioner’s Fourth-Quarter Report dated May 31, 2002, was in fact signed by Petitioner. The Fourth-Quarter Report documented that Petitioner was “deficient on multiple occasions” with regard to Patient Care; Petitioner had a “poor acquisition of a central knowledge base in Plastic Surgery”; Petitioner’s tardiness needed to “stop”; Petitioner demonstrated “immaturity” in interpersonal skills; and, Petitioner had “been acting in an unprofessional manner.” Petitioner signed a memo dated January 8, 2003, stating that he was placed on “probation” at UMDNJ during his residency due to “poor performance on the in-service examination and overall perception of weakness in academic level.” Dr. Mark Granick testified that when he used the term “probation” in the January 8, 2003, memo, the word was consistent with his own thinking, and not consistent with university definitions. Dr. Mark Granick stated that Petitioner indicated to him during their meetings at UMDNJ that Petitioner understood he was on “probation” at UMDNJ. Dr. Mark Granick testified that in his mind he considered it “probation” when he put Petitioner under direct supervision, gave Petitioner academic support, and advised Petitioner of the areas in which he needed to improve. Although the period of academic supervision imposed on Petitioner did not qualify as probation at the university level, it did constitute “probation” in the mind of Dr. Mark Granick and was understood to be “probation” by the Petitioner himself. Petitioner misrepresented to the Board the circumstances which caused him to be placed on probation at Wayne State University/Detroit Medical Center. He also misrepresented his understanding of his probationary status at both Sinai Hospital and UMDNJ. Question number 15c on the subject application asks: “Did you take a leave of absence during a postgraduate training?” Petitioner answered “no” to question number 15c on the application. But Wayne State University/Detroit Medical Center documents show that Petitioner took a month-long leave of absence. Petitioner asserts that his month-long leave of absence from Wayne State University/Detroit Medical Center was not a “leave of absence” because he used a combination of sick time and vacation time. However, Petitioner signed a Family Medical Leave Act Certification asking for a leave of absence due to his being “unable to perform work of any kind” while training at Wayne State University/Detroit Medical Center. Petitioner requested a leave of absence for one month from his training program at Wayne State University/Detroit Medical Center in March of 2001. While on leave in March 2001, Petitioner was hospitalized for benzodiazepine poisoning, pace maker insertion, and possible seizure disorder secondary to cardiac rhythm disturbance. After Petitioner’s hospitalization, Petitioner needed to have a letter clearing him to resume unrestricted activity. During this period of time Petitioner was also told that he should avoid driving motor vehicles. Once questioned by the Credentials Committee, Petitioner admitted to taking a leave of absence in 2001 while training at Wayne State University/Detroit Medical Center. Prior to being questioned by the Credentials Committee, Petitioner concealed from the Florida Board of Medicine that he took a leave of absence while at Wayne State University/Detroit Medical Center. Question number 31 on the subject application asks “In the last five years, have you been treated for or had a recurrence of a diagnosed physical impairment?” Petitioner answered “no” to question number 31 on the application. However, after questioning by the Credentials Committee, Petitioner admitted he had a pacemaker. After his hospitalization, Petitioner had to be cleared by his doctors to return to his duties as a resident. Despite Petitioner’s own definition of “physical impairment,” he concealed his hospitalization, pacemaker, and possible seizure disorder from the Board. Question number 15b on the subject application asks “Was attendance in a postgraduate training program for a period other than the established time frame?” Petitioner answered “no” to question number 15b on the application. Petitioner attended the General Surgery postgraduate training program at Medical College of Pennsylvania for one year from July 1, 1994, to June 30, 1995. Petitioner attended the general surgery postgraduate training program at Sinai Hospital for four years from July 1, 1995, to June 30, 1999. Petitioner attended the general surgery postgraduate training program at Wayne State University/Detroit Medical Center for two years from July 1, 1999, to June 30, 2001. As indicated by the foregoing, Petitioner spent seven years attending general surgery postgraduate training programs. Physicians applying for licensure by endorsement in Florida are required to show that they have completed an “approved residency program” in a “slotted” position. The Accreditation Council for Graduate Medical Education (“ACGME”) accredits postgraduate training programs, sets the standards for training programs, and determines the number of “slotted” positions a program has. The Board considers an “approved residency program” to be one that has been accredited by the ACGME. The Board relies on the ACGME in making determinations for licensure. The Board relies on the information provided in the ACGME directory when processing applications. The ACGME established time frame for completing a general surgery postgraduate training program is five years. The ACGME-established time frame for completing the postgraduate training program in general surgery at Medical College of Pennsylvania, Sinai Hospital, and Wayne State University/Detroit Medical Center was five years when Petitioner attended these programs. Thus, a five-year general surgery residency was considered standard by ACGME, the Medical College of Pennsylvania, Sinai Hospital, Wayne State University/Detroit Medical Center, medical educators, and residents like Petitioner. Therefore, Petitioner would have had to complete all his postgraduate training in general surgery within five years in order to have finished his training within the “established time frame.” It took Petitioner seven years to complete all of his postgraduate training in general surgery. Petitioner’s attendance in his general surgery postgraduate training programs was for a period other than the normal time frame established by both ACGME and by the programs he attended. Question number 15d on the subject application asks, “Were you required to repeat any of your postgraduate training?” Petitioner answered “no” to question number 15d on the application. A memo dated December 3, 1997, written by Dr. Andrew Saxe (general surgery residency programs director at Sinai Hospital) and placed in Petitioner's training file, included the observation that "this is a consequence of his being asked to repeat the current clinical year." In a memo dated April 28, 1999, also written by Dr. Andrew Saxe and also placed in Petitioner’s training file, Dr. Saxe stated, “in light of prior probation and concerns regarding clinical competency an additional year of training would be of service to him.” At final hearing, Petitioner himself explained that each postgraduate year (“PGY”) runs from July 1st of one year to June 30th of the following year. On the Verification of Postgraduate Medical Education form submitted to FCVS, Sinai Hospital listed Petitioner as only completing PGY 2 through PGY 4 while attending their program. On the Verification of Postgraduate Medical Education form submitted to FCVS Wayne State University/Detroit Medical Center listed Petitioner as completing PGY 4 and PGY 5 in their program. While attending his postgraduate training programs, Petitioner was continuously evaluated, as evidenced in his training files. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 2 from July 1995 through June 1997. That means Petitioner was a PGY 2 for two years. A review of Petitioner’s evaluation forms demonstrates that Petitioner was evaluated as a PGY 4 from July 1998 through June 2000. That means Petitioner was a PGY 4 for two years. Therefore, Petitioner repeated both PGY 2 and PGY 4 levels of training. As demonstrated by Petitioner’s postgraduate training files, Petitioner’s education levels of training did not consistently progress through the calendar years. Petitioner concealed from the Board that he had to repeat PGY 2 and PGY 4. Over the course of the last year, the Board has licensed at least 55 applicants who were found to have made one or more material misrepresentations on their licensure applications, or in the course of the licensure process.3 Over the course of the last year, the Board has licensed a number of applicants alleged to have made material misrepresentations regarding one or more of the issues raised in this matter. In a few cases that are arguably similar to the facts presented in this case, the Board has granted the license application, but with conditions that required the applicant to file a new application, to pay a new application fee, and to pay an administrative fine in the amount of $5,000.00.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order denying Petitioner’s application for medical licensure by endorsement. DONE AND ENTERED this 29th day of April, 2004, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH 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 29th day of April, 2004.
The Issue The issues to be determined are whether Respondent violated section 478.52(1)(m), Florida Statutes (2017),1/ by accepting and performing professional responsibilities that she knew or had reason to know she was not competent to perform; and, if so, what penalty should be imposed for the violations proven.
Findings Of Fact The Department is the state agency charged with the licensing and regulation of electrolysis pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to the Administrative Complaint, Respondent has been licensed as an electrologist in the State of Florida, having been issued license number EO2650. Respondent is also licensed by the State of Florida as an acupuncturist, license number AP 1378. Respondent is a certified surgical assistant, having obtained certification through the American Board of Surgical Assistants. Documents in the record indicate that in 1998, Respondent completed medical school at Universidad Libre in Barranquilla, Columbia. However, Respondent is not a licensed medical doctor in the State of Florida. Respondent’s address of record is 8210 West Waters Avenue, Tampa, Florida 33615. At all times material to the Administrative Complaint, Respondent owned and operated Orozco Medical Center (“OMC”), located at 8210 West Waters Avenue, Tampa, Florida 33615. Patient N.M. Patient N.M. is a female born in 1964. She testified that she was familiar with OMC because she had therapy there following a car accident in 2000. N.M. presented to OMC in early 2015 for consultation regarding a liposuction with fat transfer procedure, commonly called a “Brazilian Butt Lift” (“BBL”). Fat is taken from one part of the body and reinjected into the buttocks. N.M. testified that Blanca Cabrera, who performs massages at OMC, recommended a “doctor” at OMC named Marlon Barcelo to perform her BBL. Marlon Barcelo worked at OMC as a surgical assistant but was not a medical doctor. N.M. testified that she believed Mr. Barcelo would perform her BBL procedure and that she never knew that he was not a physician. Ms. Cabrera told her that Mr. Barcelo had been a very good doctor in Columbia. N.M. testified that at her initial consultation at OMC regarding the BBL, she met exclusively with Respondent, who showed her where the fat would be removed and where it would be injected. N.M. testified that she met with Respondent three times before her surgery. N.M. testified that, at the conclusion of the initial consultation, she was given an appointment card directing her to return to OMC on January 13, 2015, for an electrocardiogram, lab work, and the medication she would be expected to take before the procedure. The medical records indicate that N.M. was confused as to the dates. It appears from the records that her initial consultation was on January 13, 2015, that her EKG and lab work were performed on March 2, 2015, and the date of her surgery was March 13, 2015. N.M. testified that each time she visited OMC prior to the surgery, she met only with Respondent, who examined her and explained the procedure to her with no other persons present. N.M. testified that on the date of the surgery, her daughter drove her to OMC. After she checked in at the front desk, N.M. was taken to an exam room and told to change into a hospital gown. Respondent then marked her body to identify the locations where fat was to be removed. Respondent gave N.M. a medication to calm her prior to the procedure. The medical record indicates that N.M.’s pre- operative medications included Keflex (cephalexin, an antibiotic), lorazepam (a sedative and anti-anxiety medication), and Benadryl (diphenhydramine, an antihistamine with sedative properties). N.M. described the medication’s effect as “like a Xanax.” N.M. testified that the medication relaxed her but did not affect her recollection of the procedure. She testified that she was awake throughout the surgery and was allowed to use her cell phone during the procedure. N.M. did not recall meeting Dr. Mark Kantzler and denied ever meeting Dr. Amina Edathodu. She believed that Mr. Barcelo was going to perform the surgery, though up until the morning of the procedure she had not met him. N.M. was taken to the surgical room and placed on a table. She stated that there was a drape that blocked her view of the surgical area, but that it was low enough to allow her to see everyone in the room. She could see two men, Mr. Barcelo and someone identified as “Abel,” and Ms. Cabrera, the massage therapist, who appeared to be assisting. N.M. testified that Mr. Barcelo performed the liposuction. She testified that everyone in the room was wearing surgical gowns and gloves but no surgical masks. N.M. testified that during the liposuction procedure, Respondent told her that she would be performing the fat injections because she was very good at that procedure. N.M. testified that after the liposuction was completed, Mr. Barcelo called on Respondent to perform the fat injections into her buttocks. N.M. stated that she saw Respondent walk into the room carrying a syringe. During this portion of the procedure N.M was positioned on her stomach but stated that she knew from the conversation in the room that it was Respondent who was placing the injections into her buttocks. Upon conclusion of the procedure, Respondent gave N.M. pain medication for post-surgical pain. N.M. returned to OMC for a follow-up visit regarding the lack of drainage from her incision. During this visit, Respondent examined N.M. and gave her medication to reduce the swelling she was experiencing. Dr. Edathodu testified that she has been a licensed physician in the State of Florida for over 25 years. From 2015 through 2017, she worked as a contract physician at OMC and acted as medical director for the facility. Dr. Edathodu developed the protocols for OMC’s tumescent liposuction procedures and ensured they were followed. Dr. Edathodu remembered N.M. as a patient who had undergone previous surgeries and presented for further liposuction and fat transfer. Dr. Edathodu testified that she performed the liposuction procedure on N.M. Dr. Edathodu’s signature is on the cosmetic surgery consent form that was also signed by N.M. on March 3, 2015. The “Liposuction and Autologous Fat Transfer” consent form signed by N.M. on March 3, 2015, specifically names Dr. Edathodu as the surgeon who will perform the procedure and was signed by Dr. Edathodu. Dr. Edathodu testified that she reviewed the procedure with N.M., discussing the risks and benefits. Dr. Edathodu does not speak Spanish and uses Respondent to translate with Spanish speakers such as N.M. She identified herself to N.M. as a surgeon through Respondent’s translation. Dr. Edathodu spoke to N.M. about having realistic expectations and cautioned her that she may not obtain an optimal result because of her previous procedures. Dr. Edathodu testified that, aside from her, the persons in the surgical theater were three surgical assistants: Respondent, Mr. Barcelo, and Pavel Cabanes. It is found that Mr. Cabanes must have been the “Abel” referred to by N.M. Dr. Edathodu testified that during the surgery, there is a drape between the surgical field and the patient’s face and head, to prevent the patient from being disturbed by the sight of the procedure. The drape is made of disposable paper and is about five feet high. When performing the surgery, Dr. Edathodu is unable to see the patient’s face and the patient is unable to see past the drape. Dr. Edathodu testified that she performed the entire surgical procedure on N.M. Dr. Edathodu made the site markings on N.M. while Respondent took photographs. Respondent did not perform any part of the surgical procedure. Respondent performed none of the fat transfer on N.M. Respondent did nothing other than what Dr. Edathodu specifically directed her to do. Dr. Edathodu testified that she met with N.M. on four or five occasions after the surgery. Dr. Edathodu’s testimony, as supported by the medical records, is credited. Perhaps because of her inability to speak English, N.M. appeared confused and inconsistent in her testimony, at least as it appeared in the Transcript. N.M.’s credibility was strained by her uncertainty as to dates and medications. She offered improbable details, such as the lack of coverage by the surgical drape and the failure of the surgical team to wear masks. N.M. was certain that Respondent was performing the fat injection, even though N.M. could not see what was happening. Though N.M. testified that she was awake and alert during the procedure, the undersigned cannot disregard that she had been given a medication that she likened to Xanax, most likely the lorazepam. The undersigned hesitates to rely upon N.M.’s disjointed testimony where it conflicts with the straightforward and credible testimony of Dr. Edathodu.3/ Based on the foregoing findings of fact, it is found that the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient N.M. Patient R.C. Patient R.C. is a female born in 1988. At the time of the hearing, she worked as a claims specialist. She testified that a friend from her previous job at HealthPlan Services referred her to OMC for a consultation. She first went to OMC on or about June 6, 2016. R.C. testified that this initial consultation was with Respondent. She told Respondent that she wanted liposuction on her back and waist and wanted the fat transferred to her buttocks. They discussed the procedure and pricing. From that point until the day of the surgery, R.C. went to OMC only to drop off periodic payments for the surgery. Her only contact was with the person at the front desk. She testified that she did not see Respondent again until the day of her surgery. R.C.’s surgery was scheduled for August 5, 2016. R.C. testified that she was dropped off at OMC by her children’s father. She went in and met Respondent and a few workers in the front of the facility. When she went to the back to prepare for the procedure, she met a man wearing scrubs whom she had never seen before. Two other staff persons were present, but R.C. stated she only talked with the one staff person who spoke English. R.C. testified that Respondent and the man in scrubs marked her body for the surgery. She believed that Respondent was going to perform the surgery. R.C. stated that she was not familiar with Dr. Edathodu. R.C. stated that she filled out the consent forms on August 5, 2016. An assistant gave her medication, saying it would calm her down. R.C. was not told the name of the medication, but testified that she took a blue pill and half of a white pill. The medical records indicate she was given Ativan (a brand name for lorazepam) and Benadryl. R.C. testified that the medications made her drowsy. R.C. was assisted to the room where the surgery would be performed. R.C. testified that she was placed on her stomach, face down. Everyone in the room was wearing a surgical mask. In the room were Respondent, the man in the scrubs, and two assistants. R.C. stated that she was awake during the procedure, but was drowsy and did not recall much about it. She could hear Respondent’s voice and the noise of the liposuction machine. She could not see who actually performed the procedure. After it was over, one of the assistants phoned R.C.’s driver and helped R.C. get up and walk. Respondent handed her a bag containing pills that R.C. believed were antibiotics. She received post-operative instructions. R.C. testified that she returned to OMC for a follow- up visit about a month after the surgery and met with Respondent. Dr. Edathodu testified that she performed the surgical procedure, called “tumescent liposuction,” on R.C. on August 5, 2016. On August 2, 2016, R.C. signed a “liposuction & autologous fat transfer consent” form that specifically named Dr. Edathodu as the surgeon who would perform the surgery. Dr. Edathodu ordered, reviewed, and signed R.C.’s lab results. Dr. Edathodu met with R.C. prior to the procedure and completed a “pre-operative clearance” form to document R.C.’s fitness and willingness to go through the surgery. Both R.C. and Dr. Edathodu signed the pre-operative clearance form. Dr. Edathodu testified that she met with R.C. three or four times post-surgery. As in the case of N.M., all of the medical records support the version of events described by Dr. Edathodu.4/ Dr. Edathodu’s testimony, as supported by the medical records, is credited. R.C. frankly conceded that she did not remember much about the surgery and could not see who performed it. Dr. Edathodu clearly and credibly recalled performing the procedure. The greater weight of evidence supports the finding that Dr. Edathodu performed the surgery, assisted by Respondent and Mr. Barcelo. The evidence could not sustain a finding that Respondent performed a surgical procedure on R.C. R.C. was a more credible witness than N.M., and her testimony on some of the details regarding her consultations and pre-operative events was persuasive. However, it must be kept in mind that the only relevant factual question is whether Respondent performed an “invasive/surgical medical procedure” on R.C. The evidence on this question is not persuasive. Based on the foregoing findings of fact, it is found that the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient R.C. Patient K.H. Patient K.H. is a female born in 1989. She learned of OMC from a friend at work. She first came into OMC for a consultation regarding a liposuction and fat transfer on November 29, 2016. K.H. testified that she met only with Respondent at this initial consultation. On November 29, 2016, K.H. signed an “information certification” form accepting Dr. Mark Kantzler as the physician who would be in charge of her liposuction procedure. K.H. came back to OMC on January 9, 2017, to make a $500 deposit and to schedule the surgery. The procedure was scheduled for February 11, 2017. Again, K.H. testified that she met alone with Respondent, who told her that she would need to come in a couple of days before the surgery to get medication and a list of things she would need for post-operative care. K.H. testified that she believed that Respondent was a physician and that she would be performing the liposuction procedure. The “liposuction and autologous fat transfer consent” form that K.H. signed on February 9, 2017, authorized Dr. Kantzler to perform the liposuction and fat transfer procedure. The “surgery certification” form that K.H. signed on February 9, 2017, indicated that Dr. Kantzler reviewed the entire medical file with her before performing the procedure. On February 11, 2017, K.H. was driven to OMC by her mother. Shortly after arriving, K.H. noted the presence of a tall man with white hair and blue eyes. An OMC assistant escorted K.H. to a room with a bed and a chair. Respondent came in to the room and marked K.H. for surgery. Respondent then called in the tall man with white hair and blue eyes, who looked at the surgical markings and then asked K.H. some questions about her stretch marks. During her direct examination, K.H. testified that she was not given the man’s name. During cross-examination, K.H. was forced to concede that during an August 2017 interview, she told Department investigators that she had been introduced to the tall man with white hair and blue eyes and that his name was Dr. Mark Kantzler. K.H. testified that Respondent gave her a pill to take before surgery. She was taken to the surgical suite and was placed on the table. K.H. testified that the surgical drape prevented her from seeing the surgical area. The only people she had noted in the room were Respondent and “Claudia,” a woman K.H. recognized as a massage therapist at OMC. She could not be certain whether or not Dr. Kantzler was in the room. K.H. testified that she was awake during the surgery. She stated that she was in pain during the surgery and complained, in Spanish, to Respondent. K.H. stated that Respondent told her she had “a little stubborn fat” and continued the procedure without doing anything to alleviate her pain. K.H. testified that all conversation during the procedure was in Spanish. She heard no English being spoken. K.H. confirmed that Dr. Kantzler was the physician who signed the letter requesting that she be excused from work immediately after her surgery. Dr. Kantzler testified that he had no specific recollection of K.H. or of her procedure. He stated that he worked on a contract basis with OMC for about three years. He came in about once a week to perform liposuction procedures, conforming to the protocols established by Dr. Edathodu. He saw the patients only briefly before their procedures, relying on Respondent to perform the patient consultations and Dr. Edathodu to prescribe the pre-operative tests in her role as medical director. He was paid by the procedure. Dr. Kantzler testified that he does not speak Spanish, but that his surgical assistants, Respondent and Mr. Barcelo, would often converse in Spanish during surgery. Dr. Kantzler reviewed the medical records and confirmed that he signed the documents and performed the surgery on K.H.: Q. Is there any doubt in your mind about whether or not you performed these procedures? A. Not when I’m looking at the files, no. Q. And if you had not done the procedures, would you have signed off on the documentation? A. I wouldn’t have had them to sign. No. Dr. Kantzler’s lack of a clear recollection distinguishes this procedure from those involving Dr. Edathodu. However, an offsetting distinguishing factor is that K.H. had a clear recollection of seeing and speaking with Dr. Kantzler at OMC on the morning of her surgery. She did not see him enter the surgical suite or hear him speak during the procedure, but she was unable to say that he was not in the room. The medical record is replete with indications that Dr. Kantzler performed the liposuction and fat transfer procedure on K.H. Dr. Kantzler testified that he voluntarily relinquished his Florida medical license in 2017 “for my own reasons not relevant to this [case].” The Department’s Proposed Recommended Order suggests that this relinquishment was “in response to or in anticipation of disciplinary proceedings.” There is no record evidence to support the Department’s suggestion, and it is disregarded here. Based on the foregoing findings of fact, the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient K.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order dismissing Count I of the Administrative Complaint against Respondent, Claudia Patricia Orozco-Fandino, E.O. DONE AND ENTERED this 18th day of April, 2019, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of April, 2019.
