The Issue The issues in this case are whether Respondent, whose license to practice medicine was revoked in Maryland on a malpractice charge, is guilty in Florida of the offense of being disciplined in another jurisdiction; and if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action. RELIMINARY STATEMENT On November 18, 2011, Petitioner Department of Health issued an Administrative Complaint against Respondent Oscar Ramirez, M.D. The Department alleged that Dr. Ramirez's license to practice medicine in Maryland had been revoked by that state's licensing authority, the bare fact of which makes Dr. Ramirez's Florida license subject to secondary discipline. Dr. Ramirez timely requested a formal hearing, and on January 23, 2012, the Department filed the pleadings with the Division of Administrative Hearings ("DOAH"), where an Administrative Law Judge was assigned to preside in the matter. The final hearing took place as scheduled on March 27, 2012, with both parties present. The parties having previously stipulated to the facts alleged in the Administrative Complaint, the Department offered Petitioner's Exhibits 1 though 4, which were received in evidence without objection, and rested its case. Dr. Ramirez testified on his own behalf and presented four additional witnesses: Luis Vasconez, M.D., Vice Chairman of the Department of Surgery and professor of plastic surgery at the University of Alabama in Birmingham; Carl L. Hussling, a medical doctor and patient of Dr. Ramirez; Hilton Becker, M.D., plastic and reconstructive surgeon; and Lawrence Z. Arborella, a patient of Dr. Ramirez. Respondent's Exhibits 1 through 3 were admitted without objection. The one-volume final hearing transcript was filed on April 17, 2012, and Proposed Recommended Orders were due on May 8, 2012. The parties' respective submissions were carefully reviewed and fully considered. Citations to the Florida Statutes and Florida Administrative Code refer to the provisions in effect at the time of the operative event under discussion.
Findings Of Fact Introduction At all times relevant to this case, Respondent Oscar Ramirez, M.D., was licensed to practice medicine in the state of Florida, having been issued license number ME 76398. Dr. Ramirez is certified in Plastic Surgery by the American Board of Plastic Surgery. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Ramirez. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Ramirez committed one such offense——namely, having disciplinary action taken against a license to practice medicine in a jurisdiction other than Florida, the mere fact of which constitutes a disciplinable offense in this state pursuant to section 458.331(1)(b), Florida Statutes. In other words, under section 458.331(1)(b), the Florida Board of Medicine is authorized to take penal action against a Florida medical license based not on the licensee's having committed a "substantive violation" in this state, but rather on his having been punished in a remote jurisdiction for violating that jurisdiction's law (the "Original Violation"). Because section 458.331(1)(b) involves no independent misconduct, the Florida offense being necessarily dependent on the Original Violation for which the remote sanction was imposed, the "wrongdoing" at issue here will be referred to as the "Derivative Violation." Dr. Ramirez's Distinguished Medical Career Dr. Ramirez, a physician and surgeon for more than 25 years, has been licensed in Florida since 1998. Prior to the revocation of his medical license in 2011 by the Maryland State Board of Physicians ("MD Board"), Dr. Ramirez had never been disciplined by any licensing authority, and he has not been disciplined since. Dr. Ramirez has worked as an instructor in plastic surgery and is an Assistant Professor of Plastic and Reconstructive Surgery at Johns Hopkins University. He has served as an assistant professor in plastic surgery at the University of Maryland's medical school, and, in a voluntary capacity, on the faculty of the Cleveland Clinic Florida. In addition, Dr. Ramirez has worked as a visiting professor at more than twenty universities around the country and around the world, teaching plastic surgery techniques to medical residents. Dr. Ramirez has made approximately 500 professional presentations worldwide. These have included presentations for the American Society of Plastic Surgery, the American Society of Aesthetic Plastic Surgery, the International Society of Aesthetic Plastic Surgery, the American College of Surgeons, and the Johns Hopkins Medical and Surgical Association. Dr. Ramirez shares his skills with other practitioners and surgeons, allowing them to attend his surgeries and observe from the gallery in live surgery demonstrations. He has hosted educational workshops around the world, where he has tutored more than 4,000 surgeons in plastic surgery techniques by working hands-on with cadavers. For those physicians unable personally to attend his workshops, or those who prefer to review techniques in a different setting, Dr. Ramirez has made numerous DVDs demonstrating surgical procedures and techniques. Dr. Ramirez has written extensively on the procedures and techniques he has devised. A textbook written by Dr. Ramirez, Endoscopic Plastic Surgery, is used in many plastic surgery residencies at universities nationally and internationally. This book explains how to apply minimally invasive surgical techniques to plastic surgery, a field which Dr. Ramirez helped create and in which he remains a pioneer. Dr. Ramirez has authored chapters of textbooks, anatomy manuals, and scientific research papers——more than 150 publications in total. Twice, Dr. Ramirez has been nominated for the prestigious James Barrett Brown Award for the best scientific publications in plastic surgery. Dr. Ramirez has invented or designed surgical instruments, primarily for the minimally invasive surgery techniques he has pioneered, which are used throughout the world. He has, as well, designed surgical implants, primarily for facial reconstructions. Dr. Ramirez is responsible for developing numerous innovative surgical techniques. Among the most important are: Dr. Ramirez's innovation of sliding the gluteus maximus flap to repair wounds to the anus (often caused by cancer), which allows for the repair of the wound without causing other disabilities. Before, muscles would be transferred from the thigh or the upper chest to repair the wound, often resulting in physical impairment to the regions from which the muscles were transferred. Dr. Ramirez's technique avoids this. According to Dr. Luis Vasconez, Dr. Ramirez's sliding gluteus maximus technique has reduced significantly the suffering of patients who have undergone treatment for cancer of the anus. A technique to reattach the intestines of patients who have undergone colon cancer treatment, which improved upon earlier techniques and made the procedure safer. A surgical technique called Component Separation, used to close large abdominal defects that occur during trauma, often following complications from abdominal surgery. This technique improves patient quality of life and reduces the mortality rate. According to Dr. Vasconez, Dr. Ramirez's compartment method of repair of incisional hernias is a technique that has helped reduce the recurrence rate for large hernias (those larger than 5 centimeters) from 65 percent to 20 percent or less. This technique is used in general surgery as well as in plastic surgery. The application of minimally invasive surgical techniques in the field of plastic and reconstructive surgery, which Dr. Ramirez spearheaded. These techniques are used primarily for surgery performed on the face, breasts, and abdomen. With regard to the first area, Dr. Ramirez pioneered the suborbicularis oculi fat pad (SOOF) lift, a mid-face lift that reduces the 20 percent complication rate that was experienced using older techniques; the tridimensional functional cheek lift; and techniques to correct ear defects and twisted noses. With regard to breast surgeries, Dr. Ramirez has innovated techniques for breast reductions and nipple reconstructions. He has also developed techniques to improve tummy tucks. According to Dr. Vasconez, these minimally invasive surgery techniques, particularly endoscopy in procedures around the face, are among the most important of Dr. Ramirez's contributions to the field. Dr. Ramirez's surgical innovations are used nationally and internationally, according to Dr. Vasconez, and they have become "part of the core knowledge of plastic surgery to the point that in any training program" Dr. Ramirez's techniques are "being taught to all trainees." According to Dr. Hilton Becker, who is a board-certified plastic surgeon licensed in the state of Florida, Dr. Ramirez is an "[i]ncredible innovator," an "incredible teacher," and "a recognized expert worldwide in this field [plastic surgery]." Besides testifying to Dr. Ramirez's numerous professional contributions and international reputation for medical excellence, Drs. Vasconez and Becker testified credibly and convincingly about Dr. Ramirez's good character. Dr. Vasconez testified that in the 30 years he has known him, he has found Dr. Ramirez "highly ethical" and a "good loyal friend, and more than anything highly honest in his presentations of scientific subjects." Dr. Becker testified that Dr. Ramirez is "very well respected in the community of plastic surgery." In sum, the evidence establishes that Dr. Ramirez is a highly distinguished, world renowned plastic surgeon, prolific teacher, lecturer, and author in his field, inventor of numerous medical devices, and innovator of myriad important surgical techniques. As a practitioner and academic, Dr. Ramirez has made significant contributions to the lives of his patients and to the field of plastic and reconstructive surgery as well as to the field of general surgery. The Maryland Proceeding Against Dr. Ramirez The MD Board is the licensing authority responsible for regulating the practice of medicine in the state of Maryland. On July 15, 2011, the MD Board issued a Final Decision and Order ("Final Decision") revoking Dr. Ramirez's Maryland license to practice medicine. Employing a preponderance of the evidence standard——as opposed to the more stringent clear and convincing evidence standard required in Florida——the MD Board found that Dr. Ramirez had violated a state statute requiring doctors "to meet appropriate standards as determined by appropriate peer review for the delivery of quality medical and surgical care." The Maryland decision will be examined at length in the legal analysis below. In a nutshell, the MD Board revoked Dr. Ramirez's license based upon the determination that he had violated the standard of care on two separate occasions by performing a combination of plastic surgery procedures in a single operation in an office-based surgical setting instead of in a hospital or ambulatory surgical center. Dr. Ramirez's Current Practice Currently, Dr. Ramirez performs minor procedures under local anesthesia as an independent contractor at Elite Surgery Center in Weston, Florida. Dr. Ramirez has applied for hospital privileges in Florida, but has not yet received them. While he does not have hospital privileges himself, Dr. Ramirez now operates only with a co-surgeon who does hold hospital staff privileges. Moreover, the clinic where Dr. Ramirez works has a transfer agreement in place, and Dr. Ramirez performs surgery only with a co-surgeon who has a written transfer agreement. After the Maryland discipline, Dr. Ramirez changed his approach to surgery. Dr. Ramirez now keeps surgeries as short as possible, always following the most conservative approach. He stages multiple procedures into two or three surgical sessions or refers cases to hospital-based physicians, in full recognition of the safety advantages provided by a hospital as compared to a surgical clinic. While before the Maryland discipline he tried to keep surgeries from lasting more than eight hours, now Dr. Ramirez never exceeds six hours for a single operative session. Outside of his Florida practice, Dr. Ramirez continues his longstanding commitment to voluntary service, primarily consisting of performing pro bono reconstructive surgeries on underprivileged children in this country (providing services to uninsured children) and in Central and South America (repairing cleft lips and cleft palates). Ultimate Factual Determination Dr. Ramirez is guilty of having his license to practice medicine revoked in another jurisdiction, which is a disciplinable offense pursuant to section 458.331(1)(b), Florida Statutes.
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 Dr. Ramirez guilty of the charge set forth in the Administrative Complaint and imposing as discipline a reprimand and a fine in the amount of $1,000. DONE AND ENTERED this 10th day of July, 2012, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM 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 10th day of July, 2012.
The Issue The issue for consideration in this case is whether Respondent's license as a physician in Florida should be disciplined because of the matters alleged in the Administrative Complaint.
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Board of Medicine, through the Agency For Health Care Administration, and formerly the Department of Business and Professional Regulation, has been the state agency in Florida responsible for the regulation of the practice of medicine and the licensing of physicians in this state. Respondent has been a physician licensed in Florida under license number ME 003824. Starting on January 12, 1988 and continuing thereafter until on or about March 16, 1988, Respondent treated Patient #1 for a condition known as Dupuytren's Contracture of the left hand. This conditions results in the thickening of scar tissues and contracture of fibrous bands in the palm and fingers which pulls the fingers into the palm and constricts their ability to flex or straighten out. Patient #1 had suffered from this condition since 1982. In 1984, a surgeon in New Jersey performed Dupuytren's Contracture release surgery on the patient's right hand, but the results were not altogether satisfactory. Respondent first saw Patient #1 on January 12, 1988. At this initial visit, Respondent discussed the implications of the proposed surgical procedure and advised the patient of the possible adverse consequences thereof. He noted that because the patient had delayed seeking treatment for the left hand, there was a strong possibility of complications as a result of surgery which could involve nerve damage and infection in addition to a possibility of vascular damage and necrosis of the tissue of the hand. On February 10, 1988, Respondent performed a Dupuytren's Contracture release on the patient's left hand at the Gulf Coast Orthopedic Center, (GCOC). This surgery is a complicated, delicate and difficult procedure which in the instant case, was made even more difficult by the extent of the existing contracture of the patient's hand. After the completion of the surgery, Respondent placed Patient #1 on Keflex, an antibiotic, and also prescribed Darvocet for pain. Respondent saw Patient #1 again on February 11, 1988. At this time, the patient was complaining of pain in the hand and of the tightness of the bandage. Respondent examined the wound at this time, cleaned it, placed a plastic platform splint on the hand and re-bandaged it. The patient was also prescribed Percodan for pain and advised to continue the Keflex at a 1,500 mg/day dosage. Patient #1 returned to Respondent again on February 12, 1988, still complaining of pain and that the bandage was too tight. After again examining the hand, Respondent re-bandaged it, placing gauze between the patient's fingers and the splint. He also gave the patient another prescription for Percodan for the pain. On February 17, 1988, the patient again came to the Respondent's office for his third postoperative checkup. When Respondent removed the bandage, he noticed a small greenish area on the palm which was exuding what appeared to be white pus. Respondent thoroughly cleaned the wound by placing the hand in a whirlpool bath of water and Betadine solution for approximately 45 minutes. He did not culture the green area or the white exudation. When he released the patient that day, however, he increased the Keflex dosage to 2,000 mg/day but refused to give him a prescription for additional Percodan for the pain. Instead, he told him to take extra strength Tylenol. He also told the patient to keep the hand elevated but did not suggest the patient call in the event of pain. Respondent did not see Patient #1 again until February 24, 1988 even though the pain had increased during that period. The patient, however, did not call the Respondent to complain, believing the increase in pain was the result of the removal of the prescription for Percodan and the substitution of a lesser strength substance, Tylenol, therefor. The patient assumed, from the Respondent's prior comments, that the pain was normal and to be expected. When Respondent saw Patient #1's hand again on February 24, 1988, he became excited because it appeared there was infection in the left palm which had spread to the PIP joint of the middle finger at which point there was some necrosis. Respondent appeared upset because the Patient had not called him when the pain continued or increased. Patient #1's wife had asked that the patient do so, but the patient decided to wait until the next scheduled appointment on February 24, 1988. At this time, Respondent removed the sutures from the patient's hand and irrigated the wound with a mixture of saline solution and an antibiotic, Kepsol. A culture was also taken at this time. Since Respondent did not have hospital admitting privileges in the area, he arranged through Dr. Alea, an associate in his clinic who did have such privileges, to have Patient #1 admitted to Bayonet Point Hospital for treatment of the infection. The treating physician there was Dr. K. Sundaresh, an infectious disease specialist. The admission was on February 24, 1988. Dr. Sundaresh placed Patient #1 on prolonged antibiotic treatment, obtained a bone scan to document any infection, and directed debridement, incision and drainage of the wound. The bone scan report indicated that Patient #1 "most likely" had developed osteomyelitis, a bone infection, at the base of the middle finger on the left hand. X-rays taken around the same time, on March 1, 1988, revealed findings consistent with osteomyelitis. Following the hospital admission, Respondent departed for Arizona for three days to attend a previously scheduled medical seminar, returning on February 27, 1988. While he was gone, however, Respondent spoke daily with Patient #1 by telephone and consulted with the physicians who were treating him. Dr. Alea suggested that Patient #1 be examined by another orthopedic physician, Dr. Moss, but when Dr. Moss came to see Patient #1 in the hospital, he was told the patient had already seen Respondent. The consult report prepared by Dr. Moss reflects no consult was had because the patient "wants treatment as now arranged under Dr. Bonati." Records of GCOC indicate that on March 1, 1988, Respondent spoke with patient #1's daughter by telephone indicating that if the patient did not come to the clinic that day, he would be released from Respondent's care. In fact, the patient did go to see Respondent on March 1 and 2, 1988 on pass from the hospital, but claims he did not refuse treatment by Dr. Moss. When Respondent saw Patient #1 in his office on March 1, 1988, after noticing a greenish material on the patient's left palm which he thought might be pseudomonas, he elected to continue the antibiotic treatment that was initiated in the hospital. When the patient was released from the hospital on March 4, 1988, the wound was healing well. Dr. Sundaresh arranged for the patient to continue the intravenous antibiotic treatments through a home nursing services. The final diagnosis at the time of discharge was osteomeleyitis of the middle finger of the PIP joint on the left hand due to pseudomonas aeruginosa infection. Respondent saw Patient #1 in his office on March 7, 9, and 16, 1988, after the patient's discharge from the hospital. The patient was scheduled for another visit on March 22, 1988, but cancelled that appointment and also elected to discontinue the physical therapy Respondent had prescribed for him at GCOC. The hospital records show that while there, Patient #1 received daily physical therapy treatments consisting of whirlpool treatments to the hand and sterile dressings, starting on his admission on February 24, 1988, but no range of motion exercises. The physical therapy prescribed at GCOC by Respondent starting on March 8, 1988 included range of motion exercises which he continued until March 15, 1988. At the time of the last visit, on March 16, 1988, Respondent noted that the patient's wounds were healing well, but there was some limited range of motion. One of Petitioner's experts, Dr. Nadler, a board certified orthopedic surgeon with over 17 years experience, who is in practice with Dr. Angelides, to whom he refers all his hand surgery cases, opined that the standard of care for orthopedic surgery such as performed here by Respondent would be for the surgeon to have the ability to admit and follow the patient in a hospital if complications should arise. At very least, the surgeon should have the ability to make arrangements for another orthopedic surgeon to follow the patient in his absence. According to Dr. Nadler, it is not at all unusual for infection to occur in Dupuytren's Contracture release surgery. He concluded that Respondent fell below the standard of care when he performed a complicated surgical procedure on Patient #1 without having the personal ability to admit his patient to a hospital or to follow his patient's progress in the hospital in the event complications, such as an infection, should occur. He also concluded that Respondent's failure to have another orthopedic surgeon available to follow the patient while in the hospital was below standards as well. This opinion was shared by Petitioner's other expert, Dr. Visconti, a board certified orthopedic surgeon who, by his own admission, however, is not a hand surgeon specialist. Respondent's expert, Dr. Angelides, a board certified orthopedic surgeon who specializes exclusively in surgery to the hand and upper extremity, indicated that the presence of a green wound which exudes pus is consistent with infection. The standard of care for treating such an infection consists of cleaning the wound, obtaining cultures of the suspected infection, and seeing the patient again within a day or two for follow-up examination. In Angelides' opinion, Respondent's leaving the bandage on Patient #1's hand from the time of surgery on February 17 through February 24, without taking it off to check on the course of infection was not the way he would have handled the situation. However, he did not go so far as to state the Respondent's failure to do so was inappropriate, and he could find no impropriety in the way Respondent managed this case. Recognizing that the case presented here was about as severe an example of Dupuytren's Contracture as can be seen, Dr. Angiledes opined that the result achieved by Respondent was quite good considering the severity of the problem. He was not put off by the development of necrosis here, accepting that as a common complication in cases of this nature. He was satisfied by Respondent's calling in an infectious disease specialist and with the continuation of antibiotics administration after discharge through home health care. In his opinion, the surgery was appropriate and the ensuing complications common. The admission of the patient through an intermediary was not, to him, inappropriate so long as, as here, the patient continued to be seen by an infectious disease specialist. In substance, Dr. Angelides could see no problems with this case that were not properly handled and nothing that could have been done that was not done.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered in this case finding Respondent not guilty of the offenses alleged in the Administrative Complaint and ordering it dismissed. RECOMMENDED this 22nd day of August, 1994, in Tallahassee, Florida. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of August, 1994. APPENDIX TO RECOMMENDED ORDER 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. FOR THE PETITIONER: Accepted and incorporated herein. - 4. Accepted and incorporated herein. 5. - 7. Accepted and incorporated herein. 8. - 10. Accepted and incorporated herein. 11. - 13. Accepted and incorporated herein. - 19. Accepted and incorporated herein. Accepted and incorporated herein. - 23. Accepted and incorporated herein. 24. & 25. Accepted and incorporated herein. 26. & 27. Accepted and incorporated herein. 28. & 29. Accepted and incorporated herein. 30. & 31. Accepted. 32. - 35. Accepted and incorporated herein. 36. - 38. Accepted and incorporated herein. 39. & 40. Accepted and incorporated herein. 41. & 42. Accepted. 43. Accepted and incorporated herein. 44. & 45. No more than recitations of evidence. & 47. Accepted and incorporated herein. Rejected as a classification of Respondent's treatment as "inappropriate." The deposition cited as authority for that comment does not support it. However, the action described and the time frame in question are accurately noted. Accepted. Accepted as a recitation of the witness' testimony. Rejected as to the description "well supported." & 52. Accepted as restatements of testimony. Accepted. See "50" above. Rejected as not supported by clear and convincing evidence. FOR THE RESPONDENT: Accepted and incorporated herein. Accepted. & 4. Accepted and incorporated herein. - 9. Accepted and incorporated herein. Accepted and incorporated herein. Not an evidentiary Finding of Fact. - 14. Accepted as restatements of testimony. 15. - 18. Accepted as restatements of testimony. 19. & 20. Accepted as restatements of testimony. 21A. - O. Not proper Findings of Fact. These are more Proposed Conclusions of Law which are drawn by the Hearing Officer independently in that portion of the Recommended Order. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Steven A. Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard Tampa, Florida 33610 Paul B. Johnson, Esquire Johnson & Johnson, Post Office Box 3416 Tampa, Florida 33601 Sam Power Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Harold D. Lewis, Esquire Agency for Health care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD 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 9th day of August, 2005.
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 Should the certificate of registration of Petitioner, Professional Pain Management, Inc., License No. PMC 296, as a privately-owned pain management clinic, be revoked?
Findings Of Fact Petitioner, Professional Pain Management, Inc., License No. 296, is a pain management clinic (PMC) subject to the requirements of sections 458.3265 and 459.0137, Florida Statutes (2010).1/ PMC 296 is not wholly-owned by medical doctors (M.D.s), osteopathic physicians (D.O.s), or a combination of M.D.s and D.O.s. PMC 296 is not a health care clinic licensed under chapter 400, part X, Florida Statutes. PMC 296 has three equity shareholders. Their names and percentages of ownership interests are: Robert Ciceles (20 percent); Terra Hom (40 percent), and Erez Cohen (40 percent). None of the three equity shareholders is a physician, M.D. or D.O. Erez Cohen is, and at all pertinent times, has been president of PMC 296. He is not an M.D. or a D.O. Since at least August 2010, the owners and officers of PMC 296 were aware of the requirement that it be wholly physician-owned, effective October 1, 2010. PMC 296 was, at all times pertinent to this proceeding, not wholly-owned by physicians, M.D.s, D.O.s, or a combination of M.D.s and D.O.s. A dispute among the shareholders arising out of a dissolution of marriage proceeding has prevented PMC 296 from establishing ownership by a M.D., a D.O. or a combination of M.D.s and D.O.s. Management of PMC 296 plans to transfer ownership to physicians at an unspecified future date once the shareholder dispute is resolved. There was no evidence of any exemption from the operation of sections 458.3265 and 459.0137 presented at the hearing.
Recommendation Based on the foregoing Findings of Fact and Conclusion of Law, it is RECOMMENDED that the Department of Health issue a final order revoking the certificate of registration of Professional Pain Management, Inc., License No. PMC 296. DONE AND ENTERED this 30th day of September, 2011, in Tallahassee, Leon County, Florida. S JOHN D. C. NEWTON, II 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 30th day of September, 2011.
The Issue Whether Respondent, Ernesto Sinda Colina, M.D., violated Section 458.33(1)(t) and (v), Florida Statutes, as alleged in the Administrative Complaint and, if so, what disciplinary action should be taken against Respondent's license to practice medicine.
Findings Of Fact Respondent, Ernesto Sinda Colina, M.D. (Respondent), is and has been at all times material hereto, a licensed physician in the State of Florida, having been issued License No. ME-0031020. Respondent's last known address is 4002 West Thonotosassa Road, Plant City, Florida 33565-8593. On or about December 1, 1993, Patient E.C., a 61-year- old male, presented to the Orlando Vascular Clinic (Clinic) for evaluation of impotence. Respondent was the physician at the Clinic who treated Patient E.C. The evaluation included three visits, beginning with laboratory studies, physical examination, and concluding on December 7, 1993, with the injection of Prostaglandin E-1 into the corpora of Patient E.C.'s penis by order of Respondent. The injection of Prostaglandin E-1 produced an immediate erection which did not subside and became painful. On December 9, 1993, Patient E.C. contacted the Clinic complaining of an erection and discomfort and was advised to take Ibuprofen and pack the penis in ice. However, the rigidity persisted. Later on December 9, 1993, Patient E.C. presented to the South Seminole Hospital Emergency Room for further evaluation of a priapism (persistent erection of the penis, accompanied by pain and tenderness, resulting from a pathologic condition rather than sexual desire) of approximately 56 hours' duration. On December 9, 1993, Patient E.C. was seen by Elias Jacobo, M.D., who irrigated Patient E.C.'s corpora with normal saline and Heparin, evacuating old clots under sterile conditions and with antibiotic coverage. On December 10, 1993, Patient E.C. was re-evaluated because the priapism was continuing. On January 17, 1994, Patient E.C. returned to Dr. Jacobo due to recurrence of the priapism with tenderness and evidence of infection. That same day Patient E.C. was admitted to South Seminole Hospital (hospital) in Longwood, Florida. After Patient E.C.'s admission to the hospital, he was taken to the operating room where his corpora was drained, explored, and irrigated with alpha agonist ephedrine. The surgical procedure was performed by Dr. Jacobo. Patient E.C. was seen in consultation by an infectious disease specialist and maintained on antibiotics. The diagnosis was corporitis, which gradually resolved with proper drainage and antibiotic therapy. An injection of Prostaglandin E-1 may be used for the treatment of impotence. However, once the injection is given, the physician should monitor the patient's progress to determine what degree of rigidity is achieved over a given period of time and then make dosage adjustments. Moreover, the patient should be advised of the potential complications of procedures, such as priapism and infection. Finally, the patient should be instructed to return for an evaluation if the rigidity persists longer than four to six hours. Respondent failed to inform Patient E.C. of the risks of iatrogenic priapism, and failed to instruct Patient E.C. to return for immediate evaluation within four to six hours of persistent rigidity. Ibuprofen has no effect on reversing the effects of the Prostaglandin E-1. Recommending Ibuprofen and ice packs is inadequate treatment and is below that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances in the treatment of Patient E.C. The management of impotence with pharmacologic erection programs with injectible agents should be performed by or under the supervision of a specialist trained in the treatment of impotence, such as urology. Respondent had no such specialized training and the treatment of Patient E.C. without training was below the standard of care. Patient E.C. suffered permanent damage as a result of Respondent's treatment, which fell below the standard of care.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that Respondent's license to practice medicine in the State of Florida be revoked. DONE AND ENTERED this 27th day of April, 2000, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 27th day of April, 2000. COPIES FURNISHED: Kristy M. Johnson, Esquire Department of Health Post Office Box 14229 Tallahassee, Florida 32317-4229 Ernesto Sinda Colina, M.D. 4002 West Thonotosassa Road Plant City, Florida 33565-8593 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast BIN A02 Tallahassee, Florida 32399-1701 William Large, General Counsel Department of Health 2020 Capital Circle, Southeast BIN A02 Tallahassee, Florida 32399-1701
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
The Issue 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.
