Findings Of Fact I. Proposed findings of Medivision and DHRS Included in HO # 1. Accepted insofar as included in HO # 13. Included in HO # 2. Included in HO #6. Included in HO #5. Accepted insofar as included in HO #11. Included in HO 8 and 9. Included in HO 3 and 10 and 12, 13, and 14. Rejected insofar as inconsistent with HO #16. Accepted insofar as included in HO #2. Accepted. Not deemed relevant to results reached. Accepted insofar as included in HO #18. Included in HO #2. Accepted. Not deemed relevant to results reached.- Included in HO #2. Rejected as inconsistent with HO #14 and 15. Rejected as inconsistent with HO #15,16, and 17. Rejected as inconsistent with HO #15,16, and 17. Accepted. Not relevant to results reached. Accepted only insofar as included in HO #19. Included in HO #13, 14. Included in HO #18. Accepted. Not relevant to results reached. Rejected insofar as inconsistent with HO #l3. Included in HO #21. Included in HO #15. Included in HO #15, 16, 19, and 20. PROPOSED FINDINGS WFRMC Included in preliminary portion of RO. Accepted insofar as included in HO 42. Rejected as irrelevant. Rejected as irrelevant. Rejected as irrelevant. Included in preliminary portion of RO. Included in HO #6. Included in HO #6. Accepted insofar as not in conflict with HO #8. Rejected as irrelevant. Rejected as stating a negative. Accepted insofar as in agreement with HO #8. Accepted. Included in HO #20. Included in HO #21. Included in HO $17. Accepted. Included in HO #8. Accepted. Accepted insofar as included in HO #13. Included in Ho #21. Included in HO #16. Included in HO #16. Included in HO #16. APPENDIX JOINT PROPOSED FINDINGS OF BAPTIST HOSPITAL AND SACRED HEART HOSPITAL Accepted. Relevant portions are included in HO #1. Included in HO #4. Included in HO #3. Included in HO #3. Included in HO #3. Included in HO #6. Included in HO #8. Included in HO #7. Included in HO #8. Included in HO #10. Included in HO #10. Accepted insofar as included in HO #15. Accepted insofar as included in HO #12 and 16. Accepted insofar as included in HO #16. Rejected as conclusion of law Included in HO #18. Included in HO #18. Included in HO # 2. Rejected as not relevant. Included in HO #2. Included in HO #18. Accepted insofar as included in HO #8,9, and 15. Accepted insofar as included in HO #17. Included in HO #18. Accepted insofar as included in HO #16. Accepted. Not included because irrelevant and immaterial. Figures rejected as speculative. Accepted insofar as included in HO #17. Accepted insofar as included in HO #17. Rejected as inconsistent with HO #18. Rejected as conclusion of law. Rejected. Non-rule policy not applicable to specialty ambulatory surgery centers. ================================================================= AGENCY FINAL ORDER ================================================================= STATE OF FLORIDA DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES MEDIVISION OF ESCAMBIA COUNTY, INC., Petitioner, vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, CASE NO. 85-2443 Respondent, and WEST FLORIDA REGIONAL MEDICAL CENTER, SACRED HEART HOSPITAL OF PENSACOLA and BAPTIST HOSPITAL, INC. /
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.
Findings Of Fact Manatee Eye Clinic owns land adjacent to its existing offices and in close proximity to Manatee Memorial Hospital, on which it proposes to construct a freestanding ambulatory surgery center for ophthalmic surgery. On December 13, 1983, Manatee Eye Clinic filed an application for a certificate of need with the Department of Health and Rehabilitative Services (HRS) for approval of a capital expenditure in the amount of $627,640 for construction of a freestanding ambulatory surgery center for ophthalmic surgery. On April 27, 1984, Petitioner received written notice that the Department had denied the application. Manatee Eye Clinic consists of five practicing ophthalmologists in Manatee County, each of whom are [sic] duly licensed and provide quality ophthalmic care in the area. Manatee Eye Clinic, and the members thereof, have available sufficient resources, including health manpower, management personnel, as well as funds for the capital and operating expenditures for the project. Petitioner's proposed medical facility would be constructed in a sufficiently cost-effective manner and makes adequate provision for conservation of energy resources and incorporates efficient and effective methods of construction. Should this certificate of need be granted, Manatee Eye Clinic will accept Medicaid, Medicare, third-party pay, private pay, and charity care. The relevant service area for the proposed facility is Manatee County. The five ophthalmologists at MEC perform approximately 1,200 eye surgeries per year involving cataract removal and lens implant. At present all of these surgeries are performed at Manatee Memorial Hospital. The founder of MEC, Dr. Robert E. King, has twice served as chief of surgery at Manatee Memorial. He is presently a director on the board of directors of the company that recently purchased Manatee Memorial Hospital and removed it from its former status of a not-for-profit hospital to its current status as a for-profit hospital. If this application is granted, Manatee Memorial Hospital will lose all of these patients. Cataract eye surgery, as it is performed today, is ideally performed in an outpatient surgery setting. The five ophthalmologists currently perform an additional 600 outpatient surgical procedures per year in the existing clinic. These procedures would be performed in the freestanding surgery facility if this application is approved. Manatee Memorial Hospital is located one city block from MEC. L. W. Blake Memorial Hospital, some seven miles from MEC, has five operating rooms available for outpatient surgery but is not currently used by any of the doctors at MEC. Additionally, Ambulatory Surgical Center/Bradenton was licensed in December, 1982. This facility has not been used by MEC doctors. During the latest reporting period, 1983/1984, Manatee County and the Ambulatory Surgery Center performed the following procedures; Hospital Inpatient Outpatient Total L. W. Blake Memorial Hospital 8,800 2,752 11,552 Manatee Memorial Hospital 6,766 1,654 8,420 Ambulatory Surgery Center -- 1,525 1,525 TOTALS 15,566 5,931 21,497 (Exhibit 19) There is no shortage of operating rooms in Manatee County available for outpatient surgery. Petitioner's primary argument against using the operating rooms at Manatee Memorial Hospital are: operating room nurses are rotated and this results in nurses not being as well qualified as they would be if their duties were limited to ophthalmic surgery; eye surgery is generally elective and such surgery may be bumped from a scheduled operation by emergency general surgery; the patients are generally older than 65 and are less comfortable in hospital surroundings than they would be at an outpatient surgical facility; access to the ambulatory surgical center would be easier for these elderly patients than is access to the existing hospitals for the same outpatient surgery; the hospital charges for the outpatient surgery are approximately twice the charges proposed by Petitioner; and Medicare will pay 100 percent of the charges in a freestanding surgical facility (up to a maximum) but only pays 80 percent in a hospital setting, thereby making the use of a freestanding facility cheaper for the patient and for Medicare. MEC doctors currently use their own scrub nurses during eye surgeries performed at Manatee Memorial Hospital leaving only the circulating nurse to be provided by the hospital. No incident was cited wherein one of Petitioner's patients was "bumped" from a scheduled operation. The complication rate for cataract surgery has dropped from 10 percent to 0.1 percent in recent years as surgical procedures have improved. As proposed, the partnership owning MEC will erect and own the surgery center, will lease the equipment, most of which is presently owned by MEC, to the Petitioner; and the rent for the building will be a fixed amount per month plus 50 percent of the net operating profits of Petitioner. Proposed charges by the freestanding surgery center will be $904 per patient (for cataract removal and lens implant) This does not include the surgeon's fee. There are no methodology rules to determine need for a freestanding outpatient surgery facility. DHRS has consistently determined need for ambulatory surgery centers by taking the most recent number of surgical procedures performed in all inpatient and outpatient facilities in the county and dividing it by the county's base population for the latest year, here 1983. This gives the rate of surgeries per 1,000 population for the latest year for which statistics are available and is projected forward to the second year of operation (here 1987). The same is done for outpatient surgeries. DHRS uses the figure of 29 as the percentage of surgeries that can be performed in an outpatient setting to determine the need for outpatient surgery facilities in 1987. From this is subtracted the number expected to be performed in existing hospital and freestanding outpatient facilities to determine net need through 1987 for freestanding outpatient facilities. Applying this procedure, to which Petitioner generally concurs, except for the 29 percent factor, the following need is shown. The 1983 population of Manatee County is 162,997. 21,497 surgeries performed in 1983 x 1000 4 162,997 131.9 surgeries per 1000 population. The 1987 projected population of Manatee County is 182, 120. Multiplying this population by 131.9 per 1000 equals 24,061 surgeries expected to be performed in Manatee County in 1987. HRS estimates that 29 percent of these surgeries could be performed in an outpatient setting in 1987. Multiplying 24,051 by .29 equals 6,978 outpatient procedures possible. In 1983 there were 4,406 outpatient surgeries performed in a hospital setting in Manatee for a rate per thousand of 27. Multiplying this rate by the projected population for 1987 yields 4,931 outpatient surgeries that can be performed in a hospital setting in 1987. Subtracting from this number the projected outpatient surgeries to be performed in a hospital setting in 1987 (6,978 - 4,931) shows 2,047 to be performed in a freestanding facility. Ambulatory Surgery Center performed 1,525 procedures from June, 1983, to May, 1984. When this is projected to 1987, Ambulatory Surgery Center is expected to perform 1,715 surgical procedures. Substracting this from 2,047 leaves 332 procedures as a net need through 1987. This is below the pro forma break-even point of Petitioner and indicates the project is not financially possible. The 29 percent factor was obtained from American Hospital Association report of 1981. In 1981, 18 percent of the total surgeries were done on an outpatient basis while it was estimated that 20 to 40 percent of all surgeries could be performed on an outpatient basis. DHRS averaged the 18 percent and the maximum of 40 percent to arrive a mean of 29 percent to project need for outpatient surgery facilities. The latest figures from the American Hospital Association report is for 1982 and this shows the latest percentage of surgeries performed on an outpatient basis to be 20.8 percent. If this figure is averaged with 40 percent, the mean would rise to 30.4 percent. This is the percentage Petitioner contends should be used. Using this figure, the outpatient surgeries possible in 1987 would rise to 7,315 and a need for 669 procedures would exist in 1987. This would meet the higher break-even number presented by Respondent of 556 procedures for the second year of operation. It is noted that the experts' estimated surgical procedures that could be performed in an outpatient setting varied from 20 to 40 percent. In arriving at the 29 percent used DHRS averaged the latest actual percentages available in 1981 with 40 percent to obtain an arbitrary figure of 29 percent to use in calculating need for outpatient facilities. It is further noted that between June of 1983 and May Of 1984 Manatee Memorial Hospital performed 1,654 outpatient surgery procedures and 6,766 inpatient surgery procedures (Exhibit 14) and Blake Memorial Hospital performed 2,752 outpatient surgery procedures and 8,800 inpatient surgery procedures (Exhibit 15). Accordingly, 23.8 percent of Blake's surgery procedures are done as outpatient surgery and 19.6 percent of the surgeries performed at Manatee Memorial Hospital are done as outpatient surgeries. If the 1,200 outpatient surgeries per year performed at Manatee Memorial Hospital by MEC had been removed during this period, the percentage of outpatient surgery would have been reduced to 6.3 percent for Manatee Memorial Hospital. No evidence was presented regarding the number of ophthalmic surgeries that were performed at Blake Memorial Hospital during this period. Regardless of the potential loss of outpatient surgery cases at Blake if this application is granted, the percentage of outpatient surgeries performed in a hospital setting in Manatee County is, according to the latest data available, 22.1 percent (combining Blake and Manatee Memorial). Using 29 percent of the total surgeries projected for 1987 in Manatee County to obtain an estimate of the outpatient surgery that can be expected to be performed in a hospital setting in 1987 results in a much higher figure than the current growth rate in outpatient surgeries would suggest. Accordingly, I find a 29 percent factor more credible than a higher percentage would be in forecasting need for outpatient surgical facilities in 1987. This conclusion is further supported by the fact that most ophthalmic surgery today is performed in an outpatient setting. This was not true only a few years ago. Accordingly, there can be little additional growth resulting from ophthalmic surgery procedures going from inpatient to outpatient procedures. As a consequence, future growth in outpatient surgery must come from other surgical procedures.
Findings Of Fact Surgicare III is the sponsor of Surgicare Outpatient Center of Leesburg, a proposed freestanding ambulatory surgical center to be located in Leesburg, Florida. LRMC is an existing hospital located in Leesburg. It has four operating rooms where general surgery is performed and one cystoscopy room. Lake is an existing hospital located in Leesburg, Florida. It has three operating rooms and one cystoscopy room. Two additional operating rooms are presently under construction, one of which is intended to be used for minor surgeries under local anesthesia. Waterman is an existing hospital located in Eustis, Florida. It has four operating rooms, one urology procedures room, and one endoscopy room. Waterman has a certificate of need to add two additional operating rooms As originally proposed Surgicare's application was to construct a one- story building containing 10,000 square feet and two operating rooms. The original plans have been amended to reduce the size of the building to 8,000 square feet. The total cost as projected will not exceed $1,570,064. The service area proposed to be served by this facility includes Lake County and a 30-minute driving radius, approximately 20 miles, from Leesburg. Surgeries proposed at this facility are those surgeries, performed under general or local anesthesia, after which the patient will be able to be taken home and cared for, rather than remain overnight or longer in the hospital. Most such surgeries are elective as contrasted to emergency. Surgicare projects a total of 1 ,269 procedures in the first year and 2, 011 in the second year of operation. Based on construction costs or the original 10,000 square foot building, with permanent financing at 12 percent and these numbers of procedures, at an average cost of $390 per procedure the first year and $413 per procedure the second year, the facility will show a slight profit in the second year. The presently proposed facility containing ,090 square feet will be less costly than the 10,000 square foot facility and, even if interest is higher than the estimated 12 percent, Petitioner will be able to pass the break-even point during the second year of operation, if necessary by increasing fees. The average charge for similar surgeries in the Lake County hospitals is $1,309, so a slight increase by Petitioner, if necessary, is acceptable. There is currently no rule establishing the methodology to be used in determining need for an ambulatory surgical center. Nor is there a local health system plan applicable to such need. IRS uses a pro-competitive methodology which is based upon a policy which has not been adopted as a formal rule. This methodology uses the total reported surgery cases in a given county for the most recent 12-month period, the population estimate for the period, and derives a surgical utilization rate per 1,000 population. Similarly, the reported number of outpatient procedures in that county for the same period is used to derive the outpatient surgical use rate. Applying the outpatient use rate to projected future population, HRS then determines the number of outpatient procedures expected in future years in that service area. In evaluating ambulatory surgery center CON applications, HRS utilizes a two-year planning horizon. Surgicare is expected to complete its second year of operation in 1988, so 1988 becomes the relevant year For looking at projected need. Since December, 1982, HRS has assumed that 29 percent of all surgeries could be performed in an outpatient setting. This 29 percent target is the mean between 18 percent (the actual percentage of total surgeries which are reported to have been performed on an outpatient basis by hospitals participating in a 1981 survey by the American Hospital Association) and 40 percent (that percentage which a survey of literature relating to ambulatory surgeries projected could be performed in outpatient settings) . The outpatient surgeries performed in Lake County hospitals during the most recent reported 12-month period was well below the 18 percent average nationwide. This 29 percent target is a reasonable estimate of the percentage of surgeries that can be performed on an outpatient basis. In the past two years, as is shown by the testimony presented at this hearing, hospitals in Lake County have become more receptive to facilitating outpatient surgeries on their premises. This would have the effect of increasing the 18 percent found in 1981, if a survey similar to the 1981 survey was taken today. A more recent report of the American Medical Association indicates that this low end of the range has, in fact, risen to 20.0 percent. Accordingly, a mean of 30.4 percent of all surgeries performed on an outpatient basis is reasonable. By applying the target factor to projected total surgeries, HRS calculates the projected number of potential ambulatory surgeries for a given year in the future. Subtracting the outpatient surgeries projected to be performed in existing facilities in the future from the total potential outpatient surgeries yields a projected unmet need for outpatient surgical care. Applying the 29 percent factor to the surgeries performed in Lake County for the last 12 months reporting period and projecting this figure to 1988, HRS projects a potential need for outpatient surgeries in Lake County at 3,090. Based on the 1983 reported outpatient surgical use rate for Lake County and a target of 29 percent, 1,455 of the 3,090 surgeries would be performed in hospital settings in 1988 leaving an unmet need of 1,635 potential outpatient surgeries to be performed in Lake County. The intervening hospitals all contend that they have adequate capacity in their existing operating rooms to provide for all needed outpatient surgery in Lake Count and there will be excess capacity when the four additional approved operating rooms become operational. However, none of these existing or to be added operating rooms is dedicated to outpatient use although Lake will open in the near future an operating room in which only minor surgery under local anesthesia will be performed. Until very recently the Lake County hospitals were charging outpatient surgery patients the same charges imposed on inpatient surgery patients, except for the overnight room charge. As a result the average charge for outpatient surgery per procedure in Lake County is $1,309. Petitioner's initial proposed average charge per procedure is less than $400. Recently one or more of the Lake County hospitals have offered a flat charge for use of their facilities for minor surgeries. However, these new charges greatly exceed the charges proposed by petitioner. Many of the surgical procedures performed in hospitals are classified as emergency and take precedence in the use of operating rooms ever elective surgical procedures which most outpatient surgeries are classified. As a result it is difficult for doctors to schedule outpatient surgeries in hospital operating rooms and have those schedules met. An exception would be, of course, if the doctor reserved and kept the operating room in which he scheduled the first operation that day. The facilities now provided to patients undergoing outpatient surgery at LRMC is not well suited to outpatient surgery because outpatient surgery patients go from the operating room to the post anesthesia recovery area whether they had local or generate anesthesia. This same space is used as a postoperative recovery area for all surgical patients, some of whom have undergone serious and extensive surgery. These are not pleasant surroundings for patients following their minor surgery. LMRC outpatient surgical facilities are as good or better than those in the other Lake County hospitals. Even if the existing and approved operating rooms available in Lake County hospitals are adequate, as shared outpatient-inpatient facilities, to provide for the outpatient surgeries needed in 1989, this does not preclude the need for the proposed facilities as a competitive factor in reducing hospital costs. None of the existing, and authorized, operating rooms in Lake County are dedicated for outpatient surgery, and according to federal regulations none can be so dedicated as presently organized. Medicare has recognized the cost saving aspects of ambulatory surgical facilities by paying 100 percent of the cost of surgeries performed at dedicated outpatient surgical facilities on Medicare patients while paying only 80 percent of the cost of surgeries performed at non- dedicated facilities. At present there are no freestanding ambulatory surgical facilities in Lake County. Only freestanding facilities can be dedicated and thereby receive from Medicare 100 percent of the charge for outpatient surgery. Accordingly, this will be the only facility in Lake County capable of offering this service to the residents of Lake County. Since their rates are lower than the reimbursement Medicare would pay to Lake County hospitals for the outpatient surgery performed at these facilities, use of dedicated outpatient surgical facilities will reduce the cost of health care. The filing of the application in this case induced the Lake County hospitals to speed up the review of their outpatient surgical procedures to provide better and less costly service. Without competition in outpatient surgical procedures, the hospitals have no incentive to institute cost-cutting measures apart from the measures they may have to adopt as a result of the newly implemented diagnostic related groupings (DRG) by the federal government. However, the DRGs are primarily aimed at reducing length of hospital stays and eliminating unnecessary diagnostic procedures, rather than directly reducing surgical costs.
The Issue The issue for consideration in this hearing is whether the Intervenor, St. Joseph Hospital of Port Charlotte, should be issued Certificate of Need #6202 for the establishment of a cardiac catheterization laboratory at its facility in Port Charlotte, Florida.
Findings Of Fact At all times pertinent to the issues herein, the Department was the state agency responsible for the regulation and certification of health care facilities in this state and charged with the responsibility of issuing Certificates of Need, (CON), under the criteria set forth in Section 381.705 Florida Statutes and the Department's Rules. St. Joseph Hospital is a 212 bed general acute care hospital located in Port Charlotte, Florida, within the jurisdiction of the Department's District VIII. It is a not for profit, tax exempt corporation owned by Bon Secours Health Systems, a multi-hospital system. It offers varied medical and surgical services, including obstetrics and pediatrics, and operates a 24 hour emergency room. The facility is accredited by the Joint Commission on Accreditation and Health care Organization, and its laboratory is accredited by the American College of Pathology. Because St. Joseph opened a nursing home in Port Charlotte in 1975, Chapel Manor Nursing Home, Fawcett's predecessor, and at that time, the only nursing home in Port Charlotte, applied for and was issued a CON to convert from a nursing home to an acute care hospital and began operation as Fawcett Memorial Hospital that year. Fawcett is now a 254 bed general medical surgical acute care hospital providing a broad range of services with the exception of obstetrics and pediatrics, and is located directly across the street from St. Joseph. It offers diagnostic cardiac catheterization service only, implementing that service in August, 1989. Both Fawcett and St. Joseph have the same service area and utilize the same physicians on their medical staffs, which are practically identical. St. Joseph offers a full array of cardiology services with the exception of cardiac catheterization. As a result, any St. Joseph patient requiring cardiac catheterization must be discharged from St. Joseph and transferred to another hospital in the area which provides that service. Between January 1989 and February, 1990, approximately 97 St. Joseph patients required transfer because of the fact that St. Joseph had no pertinent program. Because of this fact, and recognizing that the Department had determined there was a numeric need for an additional cardiac catheterization lab within the district, specifically based on the under-served indigent and Medicaid patients, in February, 1990, St. Joseph submitted a letter of intent to file a CON application for the establishment of an adult inpatient cardiac catheterization laboratory at its facility in District VIII. This letter of intent was based on proper Board Resolution, and was filed not only with the District but also with the local Health Council, and the required notice was published in a local paper. Thereafter, in March, 1990, St. Joseph filed its CON application for the facility, along with the appropriate fee, with the Department, at the same time filing a copy with the local Health Council. The Department responded with an omissions letter, the requirements of which were met by St. Joseph in a timely manner, and the Department thereafter deemed the application complete. Notwithstanding Fawcett's allegations in the post hearing submission that St. Joseph's application was not complete, there was no evidence presented at hearing to so establish, and the Department deemed it both timely and ultimately complete. On on about July 17, 1990, the Department issued its State Agency Action Report and notified St. Joseph of its decision to approve the application. Approximately one month later, in a timely fashion, Fawcett filed its Petition challenging the Department's approval of St. Joseph's application. St. Joseph projects implementation of service by the unit in December, 1992. The unit will encompass approximately 3,800 square feet and will be part of and companion to a larger construction project designed to expand St. Joseph's surgical capacity. It will be located in a proposed two-story addition to the south side of the existing hospital. Total cost of the project, including construction of the building and equipment, is estimated to be approximately $2.6 million, one hundred percent of which will be financed by debt. It is estimated that interest costs over the term of the financing will be an additional $2.25 million. St. Joseph anticipates the charge for a cardiac catheterization will be $6,657.48 in 1993, and $7,123.50 in 1994. This is the same as the average charge for the procedure by existing providers in the district, adjusted for inflation in later years. The facility will be open routinely from 7:00 AM to 2:30 PM, Monday through Friday. An on-call team will, however, be available 24 hours a day although cardiac catheterization, usually an elective procedure, should not require much in the way of emergency services. Dr. Victor Howard, a Board certified internist and cardiologist, who is already on staff at St. Joseph, is projected to be the medical program director for the new facility without additional compensation. Cardiac catheterization is a relatively new diagnostic and therapeutic invasive procedure which involves the insertion of an extremely fine hollow tube through a blood vessel in the groin, up into the patient's heart. Because the patient faces danger from collateral problems such as bleeding, stroke, congestive heart failure and medication reactions, at least three staff members are required to assist the physician performing the catheterization. As with most procedures, the more it is done, the more proficient the individuals doing it become. By the same token, the medical staff assistants to the physician in charge must have specialized skills and training, and the Department rules require that in order to properly provide for therapeutic catheterization patients, an open heart surgery facility must be available within thirty minutes of the facility where the catheterization is being carried out. St. Joseph intends to rely on Medical Center Hospital in Punta Gorda, approximately ten miles away, as the required backup open heart facility. Medical Center is within the maximum thirty minute drive time criteria. It provides not only an open heart surgery program but also both diagnostic and therapeutic cardiac catheterizations. Diagnostic catheterizations, as opposed to therapeutic catheterizations, can be done on an outpatient basis. Experience has indicated that staff assistant technicians, nurses and others, are frequently not reasonably available. As a result, there is continuing competition between hospitals providing the services requiring these individuals, and this competition is often severe. Nonetheless, Fawcett has, up to the present, been able to recruit and retain adequate numbers of experienced personnel without the necessity for paying a bonus over and above normal salary. By the same token, St. Joseph believes it, too, will be able to attract and retain sufficient numbers of qualified personnel to successfully operate its laboratory as approved. At the present time, St. Joseph has ten registered nurses on staff who have cardiac catheterization laboratory experience. The laboratory, if approved, will not open at St. Joseph until the second half of 1992. At that time, manpower requirements for the project call for 3.36 full time employees, (FTE's), and that number appears capable of being satisfied by the current staff, though a cardiovascular technician, (CVT), has not yet been hired for the lab. In addition, St. Joseph appears to have on hand adequate management and supervisory personnel. It projects salary and benefits expense of almost $140,000.00 in 1993 and almost $150,000.00 in 1994. Maintenance expense is expected to approximately $65,000.00 the second year of operation. The proposed project has been enthusiastically received by the medical community in the service area. Because, in that area, the treating physician determines where the patient will be treated, support for the project by the area cardiologists is important as a positive factor for consideration. Because it has both the financial and personnel resources to provide the service, access to the service will be improved for the medically indigent and the facility's current cardiology program will be enhanced. The Florida legislature has, by its passage of Section 381.705, Florida Statutes, laid the basic analytical framework to be used in determining whether the facility here in question is needed. Consistent with the terms of the enabling statute, the Department has promulgated Rule 10-5.011, F.A.C., to implement the provisions of the statute. The rule formula provides a showing of "need" if at least 300 procedures could be performed by the new program, based on the total number of catheterizations, diagnostic and therapeutic, projected for the District. Projections for Charlotte County alone indicate 180 additional catheterizations between 1989 and 1994. Consistent therewith, the Department has determined that within DHRS District VIII, the pertinent service district, there is a numeric need for one additional cardiac catheterization laboratory. Need, however, goes beyond the question of numeric need. It is also a factual issue that requires an analysis of health planning principles and standards used within the ultimate goal of providing the best quality medical care for the citizens of this state in a sound, economically justified manner. In that regard, it is appropriate to evaluate need with an eye that looks toward avoiding unnecessary and costly duplication of services that are unnecessary. Fawcett contends there is no need for an additional lab in District VIII, based on the underutilization of existing programs. The Department's rule, the use of which resulted in a determination of need for one additional unit, does not regulate capacity. District VIII consists of Sarasota, DeSoto, Glades, Hendry, Charlotte, Lee, and Collier Counties. Sarasota and Lee Counties each have three cardiac catheterization programs while Collier has one in its only hospital. Charlotte County has two, Fawcett and Medical Center. It has already been noted that Fawcett and St. Joseph are located across the street from one another. Medical Center, which is used for therapeutic catheterizations, is located not far from the other two, and all three are Medicaid providers. All three also serve generally the same service area and use, essentially, the same medical staff. Moreover, the three facilities' cardiology staffs are essentially identical. When evaluating the service availability, however, it must be noted that Charlotte County experienced the highest relative increase in population among all the District VIII counties during the decade of the 1980's, and projections are that it will continue to lead up through 1995. At the present time, Charlotte County has the highest percentage of residents over age 65, (34%), of any of the District VIII counties. Looking at the proposed service in light of the pertinent State Health Plan, that for 1989, four preferences should be considered when evaluating the need for the proposed service. One deals with giving preference to those who propose to establish both cardiac catheterization and open heart surgical services. Since there is no established need for an open heart surgery service in the District, St. Joseph could not and does not plan to provide for one. Consequently, this preference is not pertinent here. The second preference is for those applicants who propose to establish a cardiac catheterization program in a county without any existing program. Again, this is not pertinent to the current situation. The third preference is toward applicants with a history of providing a disproportionate share of Medicaid and charity care. Here, St. Joseph is not a disproportionate Medicaid share provider, a point made by Fawcett. By the same token, however, neither is Fawcett. Fawcett did not, over the years, keep an accurate record of the number of patients to whom it provided free medical services, or of the value of those services. It claims it did not realize the importance of those numbers, concerning itself more with the provision of the service rather than with the recording of it. It was not, for most of its existence, however, a Medicaid provider, applying for and gaining that certification as of September l, 1989. Yet, during those non-certified, unrecorded years, it claims to have provided care to patients regardless of their ability to pay. While this claim is accepted as true, it is impossible to quantify it. The fourth preference is given to applicants who agree to provide services to all patients regardless of ability to pay. St. Joseph has agreed to do so and has a history of providing care to the medically indigent. So does Fawcett, but Fawcett is not an applicant, so the preference issue does not, necessarily, apply. It is clear, however, that neither the existing providers nor the applicant are precluded or disqualified as a result of the application of these preferences. Turning to the local, (District) Health Plan, which is also to be considered in the evaluation of the projects, the 1989 update of the District VIII Plan, that pertinent here, also provides for applicants to be evaluated in light of several preferences. One calls for an applicant to provide certain services, all of which are provided currently by St. Joseph. The second preference calls for the laboratory to be open no less than 40 hours a week and to provide a maximum waiting time of one month for simple, elective cases. The evidence presented indicates that the currently operating facilities meet this criteria, but also that St. Joseph will likely do the same if approved. Another preference relates to the proposed program's impact on existing providers in the area. It is here that the parties disagree radically on whether or not such an impact exists. St. Joseph has taken the position that its program will have only minimal impact on the ability of Fawcett and other existing providers to continue to provide quality economic service. On the other hand, Fawcett projects a major negative impact on its services, and claims the Department apparently failed to consider, at the time it did its initial evaluation, whether or not St. Joseph's program would adversely impact on it's existing service. Fawcett contends that its presently improving financial posture will be definitely impacted adversely by St. Joseph's implementation of the new service, if approved, in that its anticipated positive financial improvement will be reduced, if not destroyed, by the opening of St. Joseph's proposed program. Evidence produced by Fawcett tends to indicate that by 1994, if current projections hold true, Charlotte County will experience an increase of only 180 diagnostic catheterizations per year. St. Joseph's projections indicate that in that timeframe it expects to perform 509 diagnostic catheterizations per year. Simple arithmetic, then, would reveal that if those figures are correct, 329 of the 509 projected diagnostic procedures would have to come from the number of procedures performed by both Fawcett and Medical Center. Since approximately 75% of the current cardiac catheterizations performed in Charlotte County are performed at Fawcett, by far the greatest impact would be on that institution. The figures projected indicate a loss by Fawcett, then, of 232 procedures in 1993 and 318 in 1994. Medical Center's projected losses would be somewhat less, but nonetheless, such a reduction, if realized, would result in a loss of revenue to each of the existing providers from current income levels. Fawcett experienced severe financial problems during the past several years prior to the incumbency of the present CEO. In 1987 and 1988, it had financial losses which were improved in 1989 to a result showing a marginal excess of revenue over expenses. For 1990, Fawcett expects to show a profit for the first time in several years. Its prior negative operating result, however, has had a negative impact on its debt to equity ratio which, itself, is significant in that it is used by lenders as an index or flag regarding the financial health of an institution which seeks to borrow money. Because of its poor financial condition in the past, Fawcett was unable recently to borrow money needed for 1990 capital projects, and it is the increasing profit margin, which Fawcett hopes will make it more competitive in the borrowing market, that is most threatened by the proposed initiation of St. Joseph's project. The improved financial picture which Fawcett experienced in the most recent financial years has been directly attributed to the revenue earned by its cardiac catheterization program. In 1989, Fawcett determined that each cardiac catheterization patient contributed $1,927.00 to the hospital's financial health, and Fawcett contends that each patient taken from it by the opening of St. Joseph's proposed program will result in a financial loss to it. Utilizing the 1989 contribution margin projected to 1993 and 1994 reflects that if St. Joseph's program is approved, and if the anticipated numerical patient load is lost, the net financial loss to Fawcett would be in excess of $446,000.00 in 1993 and in excess of $612,000.00 in 1994. If these figures are inflated to 1993 and 1994 dollars, the loss could well be greater. Fawcett contends that it is currently experiencing a healthy improvement in its financial position which it anticipates would be substantially and adversely affected by the loss of cardiac catheterization patients to St. Joseph if that facility's project were approved as proposed. No doubt there would be a negative impact, but the degree thereof is speculative. Both the statute and the rule mentioned previously set forth criteria for the evaluation of these projects. One is the existence of an alternative to the service provided. Whereas St. Joseph contends there is no alternative diagnostic procedure preferable to cardiac catheterization, Fawcett contends there are several alternatives to St. Joseph's proposed project. Nonetheless, prior to its application, St. Joseph considered some alternatives. One was the setting up of a mobile laboratory on an interim basis. Since this could be used only by outpatients, it was determined not to meet the need of those patients requiring an inpatient procedure or of the physicians who would perform in it, and the anticipated $1.3 million cost was considered excessive for a short term fix. It is so found. Another was the possibility of establishing the lab somewhere within the hospital's existing space, but a survey of the facility quickly revealed there is no available existing space. However, since a part of the service proposed by St. Joseph would include outpatient catheterization, this part of the need could be met by the laboratory established in Charlotte County by several cardiologists who practice on the staff of St. Joseph, and who recently established a facility in the county. By the same token, if a need for outpatient procedures is demonstrated, the existing inpatient program could, Fawcett contends, provide it. Finally, is the existence of under-utilized programs at Fawcett and the Medical Center which have existing excess capability which could be considered an adequate and available alternate to the St. Joseph program. Turning to the question of financial feasibility, another evaluation criteria, there is no doubt that St. Joseph has the ability to borrow the capital to make the project financially feasible in the immediate future. St. Joseph's financial condition is sound. As might be expected, there is substantial difference in opinion as to the reasonableness of the pro forma projections submitted by St. Joseph's as evaluated by the Department. In fact, the parties agree to very little. St. Joseph contends that the patient mix estimated in the application is reasonable and based on its experience and that of Lee Memorial Hospital, and that the staffing level is appropriate and reasonable, and there is little to contest. The major difference in positions is in the area of supply costs and the percentage of patients accounted for by Medicare. St. Joseph estimated a supply cost of $248.00 per admission in 1989 dollars, inflated by 7% per year up to 1993 and 1994, but Fawcett contends the actual supply cost in 1989 dollars is $492.00 per admission. Assuming, arguendo, that Fawcett is correct, the projected supply costs would then be increased by in excess of $85,000.00 in 1993 and almost $126,000.00 in 1994, and this would result in a reduction of projected income for the service in both years. Fawcett's evidence and argument here are not persuasive, however. Fawcett also contends that St. Joseph's assumption that 58.9% of the cardiac catheterization patients would be Medicare, a figure which assumes that the Medicare patient utilization for catheterization would be the same as the facility as a whole, is not reasonable. Fawcett relies on the fact that St. Joseph is the sole obstetrics provider in Charlotte County and the majority of these obstetric patients are not Medicare patients. Considering that along with the fact that cardiac catheterization is a service which has a higher level of Medicaid utilization than St. Joseph presently provides, a more likely and reasonable predictor of the Medicare utilization of St. Joseph's program would be the Medicare utilization for the two existing catheterization programs. Fawcett's utilization in that regard is 64.6% and Medical Center's is 70.5%. Extrapolating from those figures, Fawcett contends a reasonable financial projection for St. Joseph's program would be 65% Medicare utilization. Since that type of service is reimbursed on the basis of DRG, the amount of income to the hospital is less, and the resultant contractual allowances, deductions from revenue, would be in excess of $61,000.00 in 1993 and more than $87,000.00 in 1994. Therefore, combining both the increase in projected supply costs and the decrease in projected income from Medicare, Fawcett contends that the projected number of catheterizations in 1994 and 1994, as modified using Fawcett's figures would result in a net reduction of approximately $210,000.00 in the former year and in excess of $126,000.00 in the latter. If those figures prove correct, St. Joseph's proposed program , it is suggested, would apparently not be feasible in the long term. On the other hand, St. Joseph contends its utilization figures for 1993 and 1994 are reasonable in that it projects a volume slightly greater than one-half of the number of procedures accomplished by Fawcett in its first year of operation. St. Joseph's expert evaluated the use projections for the first two complete years of operation and the costs assumptions and found both to be reasonable. Nonetheless, he also accomplished calculations of profitability utilizing Fawcett's suggested increased costs figures, and utilizing three different approaches, ultimately concluded that even looking at the worst case scenario, St. Joseph's proposal would be financially feasible both in the short and the long term. Independent analysis of the evidence leads to the conclusion that the projected staffing level and the salaries and benefits for that staff are reasonable. The anticipated reimbursements on the basis of the DRG's are reasonable. The projected utilization in the first and second years of operation are reasonable, and taken together, the evidence supports the conclusions drawn by St. Joseph's expert. It is so found. Another area for consideration is the impact St. Joseph's program would have on Fawcett's existing program. Fawcett's program has now been in operation for several years and even with approval of St. Joseph's, will continue to operate without competition until the second half of 1992, after which St. Joseph's program would be in a start-up configuration for at least a year. As such, it will be well into 1993 and possibly into 1994 before St. Joseph's program can be considered to have its full impact vis-a-vis the Fawcett program. Fawcett's expert, who concluded that St. Joseph's program would have a serious adverse effect on Fawcett's ability to contribute to its improving financial picture did not consider the fact that Fawcett does not currently perform outpatient cardiac catheterization procedures, and any of that nature done by St. Joseph should have no impact on Fawcett. The expert also did not consider in his analysis of impact any population growth beyond 1990 or growth in the demand for diagnostic catheterization procedures. Fawcett listed approximately $13.7 million in proposed capital expenses over the next five years which, it claims, will be adversely impacted by the effect of St. Joseph's proposed program on its cash picture. Many of the line items within this figure are much the same as normal routine replacement items, and only $3.5 million represent the cost of items specifically identified as needed to meet existing life safety code violations or for accreditation purposes. No doubt there will be some impact on Fawcett's operation by the opening of St. Joseph's program, yet Fawcett has not demonstrated clearly that the impact will result in a return to the pre-1990 negative cash position which was shown to now be reversing. Even accepting Fawcett's expert's assumptions, the likelihood is great that Fawcett's equity balance would increase by over $900,000.00 from 1992 to 1993 and by over $800,000.00 from 1993 to 1994. So long as Fawcett's cardiac catheterization program performs more than 182 procedures per year, its current break-even point, no negative impact to the hospital's overall financial picture is likely to occur. Assuming that Fawcett's procedures were no more than one-half its 1990 admissions, at current rates, its program would render a positive contribution of more than $650,000.00 to the hospital's financial picture. This figure could not be considered as other than a viable financial contribution. What is more, the implementation of the program at St. Joseph should not exert any upward pressure on the cost of other services rendered by St. Joseph, and should, by competition, moderate future price increases for this procedure at the two competing facilities. As regards Medicaid and indigent care, St. Joseph has been a Medicaid provider since 1965 and has a history of providing service to indigent patients and under-served groups. In fact, the value of care rendered without cost to patients by St. Joseph has climbed from $418,000.00 in 1988 to a projected $1.5 million in 1991. By the same token, its commitment to Medicaid has increased to almost 4% in 1990, in addition to approximately 2% of uncompensated care that same year. The obstetric unit has been shown to operate $500,000.00 a year in the red because of the volume of indigent care provided. Nonetheless, St. Joseph agrees to accept a condition to its CON requiring it to provide 1.5% Medicaid and 2% charity care. In comparison, Fawcett was not certified for Medicaid until late 1989 and its experience since that time has not been substantiated. This tends to underscore the Department's contention that Medicaid and charity patients are under-served within the Charlotte County area. Other criteria outlined within the statute have not been shown by evidence presented, as being significantly affected one way or the other by the implementation of St. Joseph's proposed program. Several of the statutory criteria are, in fact, not applicable to the proposed project in this case. Much the same can be said for the criteria outlined in Rule 10-5.011(1), F.A.C., which tend to overlap to a substantial degree with the statutory review criteria. Fawcett claims that the application filed with the Department by St. Joseph is "very incomplete" in that it omits significant information regarding project costs, capital expenses, source of funds, and a litany of other required information. It claims, therefore, that the Department could not have conducted any meaningful review of the application based upon the information provided. The Department's representative, Ms. Dudek, admits that most, if not all applications omit some information. That is the purpose of the omissions letter which is sent to an applicant after initial review. Not all information called for by the statute is deemed essential however. If an omission is considered immaterial, it will not cause the application to be denied, all other essential material being provided. There are primarily two criteria called for by the statute which are essential to Departmental approval. The first deals with the applicant's access to resources to develop and operate the project, and the second is that the applicant offer quality care. In this case, both were deemed to have been met as was stipulated to by Fawcett. In the instant case, the Department's representative concluded that St. Joseph's application was one of the most thorough and comprehensive, in terms of presentation and backup, to have been filed within the past few years.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered by the Department approving St. Joseph's application for an inpatient cardiac catheterization laboratory, (CON #6202) for District VIII. RECOMMENDED in Tallahassee, Florida this 4th day of April, 1991. 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 4th day of April, 1991. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-5815 The following constitutes my specific rulings pursuant to Sec 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. & 4. Accepted. 5. & 6. Accepted. 7. - 10. Accepted and incorporated herein. 11. & 12. Accepted. 13. & 14. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted and incorporated herein. 22. - 26. Accepted and incorporated herein. 27. - 34. Accepted. Rejected. - 39. Accepted. 40. - 42. Accepted and incorporated herein, except for the first sentence of Finding 41. Rejected. Accepted and incorporated herein. & 46. Accepted. Rejected. Rejected. - 51. Accepted and incorporated herein. Accepted. Accepted. Not proven. - 59. Accepted and incorporated herein. Accepted that the loss of revenue will have an impact but the loss has not been shown to be substantial. - 65. Accepted and incorporated herein. 66. & 67. Accepted. 68. - 76. Accepted incorporated herein in substance. Rejected that the loss of revenue would "cripple" the health trend. It would adversely affect it but not cripple it. - 83. Accepted and incorporated herein. 84. - 90. Accepted. Accepted. Accepted and incorporated herein. - 97. Accepted that there are alternatives, but rejected that they are acceptable or adequate. Rejected as too broad a statement. Rejected as to the conclusion of waste. & 101. Accepted. Ultimate conclusion rejected. Need for level of education and experience accepted. Accepted. Underlying fact accepted. Balance is editorialization. - 108. Accepted. Accepted. Not an appropriate Finding of Fact. Accepted. & 113. Accepted and incorporated herein. 114. - 116. Rejected. Accepted. & 119. Rejected. 120. & 121. Accepted and incorporated herein. Rejected. - 126. Accepted. 127. & 128. Accepted. 129. & 130. Rejected. 131. & 132. Accepted. 133. & 134. Rejected. Not a Finding of Fact but a comment of the state of the evidence. Accepted. & 138. Accepted. Accepted. Rejected. & 142. Accepted. Rejected. St. Joseph was a Hill-Burton hospital. Accepted. Accepted that St. Joseph receives funds from taxes and other sources, but the conclusions that aid to Medicaid an the indigent "is to be expected" is an unjustified conclusion. 146. Accepted. 147. Accepted but probative value questionable. 148. Accepted that it is less costly. 149. First two sentences accepted. Remainder not proven. 150. Rejected. 151. & 152. Accepted in the short term. 153. Accepted. 154. Not proven. 155. Rejected. 156. - 158. Rejected. 159. & 160. Accepted. FOR THE RESPONDENT AND INTERVENOR: 1. - 3. Accepted and incorporated herein. Accepted. - 8. Accepted and incorporated herein. Accepted. - 13. Accepted. 14. - 16. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted. 22. - 24. Accepted and incorporated herein. Accepted and incorporated herein. - 28. Accepted and incorporated herein. Accepted and Incorporated herein. - 35. Accepted and incorporated herein. 36. - 41. Accepted and incorporated herein. Accepted. - 45. Accepted and incorporated herein. 46. & 47. Accepted. 48. & 49. Accepted and incorporated herein. 50. & 51. Accepted. 52. - 54. Accepted and incorporated herein. 55. - 58. Accepted. 59. & 60. Accepted and incorporated herein. Accepted. Accepted. & 64. Not Findings of Fact but a comment on the state of the evidence. 65. & 66. Accepted and incorporated herein. Not a Finding of Fact but a statement of party position. Not a Finding of Fact but a comment on the evidence. & 70. Accepted and incorporated herein. 71. & 72. Accepted and incorporated herein. Accepted. Accepted. Not a Finding of Fact but a comment on the evidence. Accepted. - 80. Accepted and incorporated herein. Accepted but irrelevant to the issues here. Accepted but considered more a statement of party position and a comment on the evidence. & 84. Accepted and incorporated herein. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted and noted in the Conclusions of Law portion of the Recommended Order. - 100. More proper as Conclusions of Law than as Findings of Fact, but accepted where pertinent. COPIES FURNISHED: John D. C. Newton, II, Esquire Aurell, Radey, Hinkle & Thomas Suite 1000, Monroe-Park Tower P.O. Drawer 11307 Tallahassee, Florida 32302 Richard Patterson, Esquire DHRS 2727 Mahan Drive Tallahassee, Florida 32308 R. Terry Rigsby, Esquire Philip Blank, P.A. P.O. Box 11068 Tallahassee, Florida 32302 Linda K. Harris Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700
The Issue Whether Respondent, a medical doctor, in his treatment of Patient M.A., failed to keep legible medical records in violation of section 458.331(1)(m), Florida Statutes (2007); prescribed or administered inappropriate or excessive quantities of controlled substances in violation of section 458.331(1)(q), Florida Statutes (2007); committed medical malpractice by practicing below the standard of care in violation of section 458.331(1)(t), Florida Statutes (2007); failed to perform a statutory or legal obligation placed upon a licensed physician in violation of section 458.331(1)(g), Florida Statutes (2007); and violated any provision of chapter 458 or chapter 456, or any rules adopted pursuant thereto in violation of section 458.331(1)(nn), Florida Statutes (2007), as Petitioner alleges in the Third Amended Administrative Complaint; if so, whether (and what) disciplinary measures should be imposed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Paul M. Goldberg, M.D., violated sections 458.331(1)(g) and (nn), Florida Statutes, as charged in Counts IV and V of the Complaint; Dismissing Counts I-III of the Complaint; Imposing $20,000 in administrative fines; issuing a reprimand against Dr. Goldberg's medical license; requiring Dr. Goldberg to complete the "Laws and Rules" Course; suspending Dr. Goldberg's medical license until such time as Dr. Goldberg undergoes a "UF CARES" evaluation; and placing Dr. Goldberg's license on probation for three years under indirect supervision with 100 percent chart review of cosmetic surgery patients and 25 percent chart review of all other patients. DONE AND ENTERED this 4th day of March, 2015, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of March, 2015.
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 Whether the Respondent committed the violations alleged in the Administrative Complaint filed July 7, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2006). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2006). Dr. Edison is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 44240. Dr. Edison received his medical degree from the University of Massachusetts; did his residency in general surgery at the Kaiser Foundation in Los Angeles, California; and did a residency in plastic surgery, with specialties in reconstructive surgery and cosmetic surgery. Dr. Edison is certified in plastic surgery by the American Board of Plastic Surgery and is a lifetime diplomate of that Board. Dr. Edison was also certified in Advanced Cardiac Life Support ("ACLS") at the times material to this proceeding. Dr. Edison has been practicing plastic surgery in Florida for 22 years. Prior to the time material to this proceeding, Dr. Edison performed approximately 150-to-200 breast augmentation surgeries each year and approximately 100-to-150 liposuction procedures each year. Dr. Edison practices at the Cosmetic Surgery Center, which is an office that contains two operating rooms, a recovery room, and an overnight recovery facility that is staffed by an ACLS-certified nurse for patients who undergo procedures such as stomach tucks or facelifts. Dr. Edison's surgical practice is limited to Level II office surgery, which is defined in Florida Administrative Code Rule 64B8-9.009, Standard of Care for Office Surgery, in pertinent part as follows: Level II Office Surgery. Scope Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, this making intra and post- operative monitoring necessary. . . . Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Standards for Level II Office Surgery. * * * 4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. . . . The level of pain and anxiety management achieved under Level II sedation is determined by the type of drugs administered and the dosages in which they are administered. Dr. Edison was ACLS certified and was, therefore, authorized to use the services of a registered nurse to administer the drugs that bring patients to Level II sedation. He does not use the services of an anesthesiologist or of a Certified Registered Nurse Anesthetist in his surgical facility. Patient P.L. P.L. first consulted with Dr. Edison on July 5, 2005. P.L. filled out a portion of a Patient Information form, and Dr. Edison took a general medical history from P.L., but he did not weigh P.L. during this initial visit, and the Patient Information form does not include her blood pressure, height, or weight. Dr. Edison found P.L. to be a healthy 29-year-old female, the mother of three children, who had no known allergy or adverse reaction to any medication. P.L. wanted breast implants, and, upon examination, Dr. Edison found that P.L. would be a good candidate, anatomically, for the surgery. Dr. Edison spent the majority of time during this initial consultation talking with P.L. and her husband, A.A., about the various breast implant options. He also discussed with them the risks and possible complications of the surgery. After her visit to Dr. Edison's office on July 5, 2005, P.L. notified Dr. Edison's office that she had decided to have the surgery. Dr. Edison had a cancellation on July 7, 2005, and P.L. was scheduled for surgery for 8:00 a.m. on that date. P.L. returned to Dr. Edison's office on July 6, 2005, for a pre-operative examination. At that time, Dr. Edison did an examination during which he checked P.L.'s heart, lungs, blood pressure, and pulse rate, and he noted the results in his examination notes dated July 6, 2005. He found nothing abnormal and concluded that P.L. was a 29-year-old patient in perfect health, with no known allergy or adverse reaction to any medication. Dr. Edison also had blood drawn during the July 6, 2005, office visit, which was sent to a laboratory for testing. The laboratory report was completed at 8:21 a.m. on July 7, 2005, and showed nothing abnormal. P.L. presented herself at Dr. Edison's office on July 7, 2005, at approximately 8:00 a.m. She was examined by Dr. Edison at 8:10 a.m., and he stated in his office notes that she had decided on the 300 cubic centimeter implant. There were no notations of her vital signs in his office notes. Dr. Edison intended for P.L.'s breast augmentation surgery to be Level II office surgery, and he noted this on P.L.'s Immediate Pre-Op Evaluation, which he completed on July 7, 2005. He also decided to use the transaxillary technique, making incisions under the arms through which to insert the implants under the muscle in P.L.'s chest. Dr. Edison was assisted during surgery by Michelle Hoff, an Advanced Registered Nurse Practitioner, who administered the sedatives and other drugs to P.L. under Dr. Edison's direction. Dr. Edison was also assisted by Liliana Gabor, a surgical technician. Ms. Hoff is not a Certified Registered Nurse Anesthetist, nor has she received any formal training in administering sedative drugs or anesthesia. She has a significant amount of experience administering drugs for pain and anxiety management. Her experience administering drugs to achieve Level II sedation consists of an externship with Dr. Edison while working on her master's degree in nursing and extensive on-the-job training while working in the operating room with Dr. Edison, which she has done every day since beginning to work with Dr. Edison full-time in November 2003. At some point immediately prior to surgery, Dr. Edison asked P.L. her weight, which she reported as 95 pounds, or 43 kilograms, on the morning of surgery. Dr. Edison needed to know P.L.'s weight in order to calculate the correct dosage of the drugs she would be given, and he wrote "95 lbs" on the outside of P.L.'s folder. Dr. Edison noted P.L.'s weight on the outside of the folder so it would be plainly visible to Ms. Hoff when she had the chart on the anesthesia stand.4 Dr. Edison did not enter P.L.'s weight in his examination notes, and the only other mention of P.L.'s weight in the medical records maintained by Dr. Edison is the notation "<100 lbs" on a sheet containing the contact numbers for P.L. and for her husband, who would be picking her up after surgery. At approximately 8:20 a.m. on July 7, 2005, P.L. walked to the operating room. Working under Dr. Edison's direction, Ms. Hoff hooked P.L. up to various monitoring devices, so that her heart, blood pressure, and oxygen saturation level could be monitored during surgery. Her vital signs were noted on the anesthesia chart by Ms. Hoff; at 8:20 a.m., P.L.'s heart rate was approximately 104. At 8:20 a.m., Ms. Hoff began to administer drugs to P.L. to achieve Level II sedation in accordance with directions from Dr. Edison; she documented the name of the drugs she administered, together with the time and dosage administered; she monitored and documented P.L.'s vital signs, including heart rate, blood pressure, and oxygen saturation level; and she maintained anesthesia notes. At 8:20 a.m., Ms. Hoff administered two milligrams of Valium; one gram of Ancef, and 0.2 milligrams of Robinol at Dr. Edison's direction. At 8:25 a.m., she administered 10 milligrams of Ketamine and 10 milligrams of Talwin and started the administration of Diprivan by microdrip at the rate of approximately 25 micrograms per kilogram of weight per minute. Ms. Hoff's notes do not indicate the manner in which she administered the Diprivan, nor the dosage or rate of administration. Ms. Hoff also administered nitrous oxide and oxygen at 8:25 a.m., and she noted that Dr. Edison also began administering local anesthetic by injection at 8:25 a.m. Ms. Hoff noted that P.L. was responding to verbal stimuli. Ms. Hoff was not involved with the preparation or administration of local anesthetic to P.L. Dr. Edison prepared a dilute solution of 70 cubic centimeters of 1% Lidocaine with epinephrine with 350 cubic centimeters of saline solution and 10 cubic centimeters of 1/2% marcaine. At approximately 8:25 a.m., Dr. Edison began injecting the Lidocaine solution, which totaled approximately 700 milligrams or approximately 14 milligrams of Lidocaine per kilogram of P.L.'s body weight and 50 milligrams of marcaine, into the tissue surrounding P.L.'s breasts. At 8:30 a.m., Ms. Hoff, at Dr. Edison's direction, administered another 10 milligrams of Talwin. At 8:35 a.m., P.L.'s heart rate was 112 beats per minute and her blood pressure was 142/102. At Dr. Edison's direction, Ms. Hoff administered 1/4 cubic centimeter of Labetalol to help control P.L.'s blood pressure. Ms. Hoff noted that P.L. tolerated the Labetalol well and was responsive to verbal stimuli. At 8:45 a.m., Ms. Hoff noticed a brief facial twitch on P.L.'s face, which is an indication of a possible seizure. At Dr. Edison's direction, she immediately stopped administering all sedatives, and the surgery was cancelled. At Dr. Edison's direction, Ms. Hoff administered 2.5 milligrams of Valium to keep P.L. sedated and to help control the seizure, together with three liters of oxygen by mask. At 8:55 a.m., Ms. Hoff administered another 2.5 milligrams of Valium at Dr. Edison's direction,5 and she noted that P.L.'s status was unchanged, by which Ms. Hoff meant that P.L.'s airway, breathing, and circulation were maintained, that her vital signs were stable, and that she remained responsive to verbal stimuli. Between 8:55 a.m. and 9:15 a.m., P.L.'s status was unchanged. According to Ms. Hoff's notes, P.L.'s airway, breathing, circulation, and vital signs were maintained at normal levels, and she responded well to the Valium and oxygen. Ms. Hoff observed during this time that P.L. was lethargic and appeared to be a little more deeply sedated than typical Level II sedation. P.L. continued breathing on her own and responding to verbal stimuli. During this interval, Dr. Edison was waiting for P.L. to come out of sedation, and he intended to send her home and recommend that she see her doctor about the twitch. Ms. Hoff noticed a second facial twitch between 9:15 a.m. and 9:20 a.m., and Dr. Edison directed Ms. Hoff to call Emergency Medical Services to transport P.L. to the hospital. Ms. Hoff continued to monitor P.L.'s airway, breathing, circulation and vital signs until the Emergency Medical Services team arrived at 9:30 a.m. During this time, Ms. Hoff noted that P.L. responded to verbal stimuli by moving her head a little bit and attempting to open her eyes. P.L.'s oxygen saturation rate was consistently maintained at 99% to 100% between 8:20 a.m. and 9:30 a.m., when Emergency Medical Services arrived. During this time, P.L. was breathing independently and did not need any assistance with her airway. Emergency Medical Services received the call from Dr. Edison's office at 9:21 a.m. and arrived at 9:26 a.m. At that time, P.L. was receiving oxygen, her airway was normal, and her perfusion was good. Her blood pressure was 102/68, her pulse was strong and regular at 120 beats per minute, her respiratory rate was 20, her respiratory effort was normal, and her breath sounds were clear. She was, however, non-responsive: She was not able to open her eyes, she had no motor response, and she was not able to give a verbal response. She appeared to be having seizure activity in the form of twitching on both sides of the jaw line. P.L. was transported to Memorial Regional Hospital at 9:31 a.m., and she arrived at the hospital at 9:36 a.m. A notation on the EMS Report for the incident states that a "[l]ist of sedation medication [was] given to ER staff." Dr. Todd Gardner was the emergency room physician who treated P.L. on her arrival at Memorial Regional Hospital. His diagnosis on admission was status epilepticus and hypoxia. Status epilepticus is seizures that are unrelenting to normal therapeutic intervention, and hypoxia is low oxygen level. Dr. Gardner did not attribute a cause to the status epilepticus. Dr. Gardner's intake notes reflect that, prior to presenting at the emergency room, P.L. had received Ketamine, Labetalol to lower her blood pressure, and Valium to relieve the seizures. Nothing on the intake sheet indicates that P.L. had received Lidocaine, and there is no list of the medications given by Dr. Edison in the hospital file. Dr. Gardner intubated P.L. at 10:02 a.m. and placed her on a ventilator in the emergency room because she was unable to breathe on her own. He also treated her with Valium, Dilantin, and Diprivan, which is used to sedate patients in the intensive care unit. Dr. Robert Alterbaum, an internist specializing in pulmonary medicine and critical care, provided care to P.L. in the intensive care unit of Memorial Regional Hospital. P.L.'s chest X-ray was abnormal and showed pneumonitis, or an inflammation of the lungs, caused by fluid being aspirated into the lungs. Based on the emergency room chart, Dr. Alterbaum diagnosed P.L. with status epilepticus, or seizures, related to the administration of Ketamine during the pre-operative procedure for breast augmentation surgery. There was no objective medical evidence to support Dr. Alterbaum's conclusion that Ketamine was the cause of the seizures; he reached this conclusion because Ketamine was the only medication noted on the chart as having been administered to P.L. Dr. Alterbaum was not aware that P.L. had also received Lidocaine; had he been aware of this, it might have been information he would have considered in reaching his conclusion regarding the cause of P.L.'s seizures.6 P.L. was discharged from Memorial Regional Hospital on July 12, 2005. She had difficulty walking at first, but has fully recovered except that she sometimes experiences a little memory loss. Drugs administered to P.L. Valium Valium is a benzodiazopene used to control anxiety, and the standard dosage ranges from two to 20 milligrams for conscious sedation. Valium is a controlled substance. Ancef Ancef is an antibiotic. Ketamine Ketamine is a disassociative non-barbiturate analgesic used for sedation and general anesthesia; the maximum dosage is 4.5 milligrams per kilogram of body weight. Ketamine causes a large amount of secretions, and its effects last only five to 10 minutes. Ketamine is a controlled substance. Robinol Robinol is an anticholinergic medication used to prevent bradycardia, a heart rate of less than 60 beats per minute, and to help dry out secretions in mucous membranes. Robinol is contraindicated for a patient with tachycardia, or a heart rate of more than 100 beats per minute, however, because it could make the patient's heart rate increase. In a healthy 29 year-old patient such as P.L., however, it was not a violation of the standard of care to administer 0.2 milligrams of Robinol to P.L. even though her heart rate was 104 beats per minute at the time it was administered; a healthy 29-year-old patient could easily sustain a heart rate of 140 beats per minute without ill effects. Dr. Edison administered Robinol to P.L. as a drying agent, to control secretions brought on by the use of Ketamine. Although other drugs can be used to control these secretions, Robinol is the best drug for this purpose and the one most commonly used. Dr. Edison had ample justification for using Robinol under the circumstances, and he did not violate the standard of care by ordering Ms. Hoff to administer the drug even though P.L.'s heart rate slightly exceeded 100 beats per minute. Talwin Talwin is an opiate analgesic that is used to control pain, and the standard dosage is 30 milligrams. Talwin is a controlled substance. Nitrous oxide Nitrous oxide is an anesthetic gas that is used for analgesia and sedation; it was administered to P.L. by nasal cannula, which delivers a relatively small amount of gas. Diprivan Diprivan is a sedative hypnotic medication used both for intravenous sedation and for general anesthesia; the package insert recommends a dosage from 100 to 150 micrograms per kilogram of body weight per minute. Diprivan's clinical effects wear off approximately three minutes after its administration is discontinued. The total dose of Diprivan administered to P.L., 25 milligrams, was included in Dr. Edison's medical records, but the manner of administering the Diprivan and the rate of infusion are not recorded. Diprivan, together with other sedative drugs, may be administered in Florida by a registered nurse at the direction and under the supervision of a surgeon during Level II office surgery.7 Dr. Edison did not deviate from the standard of care in Florida by delegating responsibility to Ms. Hoff, an Advanced Registered Nurse Practitioner, for administering the various drugs to P.L., under his direction and supervision. Based on her training and experience, Ms. Hoff was qualified to administer these drugs to P.L. to achieve Level II sedation under Dr. Edison's direction and supervision. The combination of sedative drugs Dr. Edison ordered administered to P.L., specifically Diprivan, Ketamine, Talwin, Valium, and nitrous oxide, was appropriate to induce Level II sedation in P.L., and the dosage of each of the drugs administered to P.L. was well below the maximum dosage recommended for each of the drugs. These drugs work synergistically, however, and, depending on the patient and the circumstances, the same combination of sedative drugs could induce Level III sedation. Florida Administrative Code Rule 64B8-9.009 defines Level III office surgery and sets forth the standards that must be met, in pertinent part, as follows: Level III Office Surgery. Scope. Level III Office Surgery is that surgery which involves, or reasonable should require, the use of a general anesthesia or major conduction anesthesia and pre- operative sedation. This includes the use of: Intravenous sedation beyond that defined for Level II Office Surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions: or Major conduction anesthesia. * * * Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: * * * 4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. . . . One difference between Level II and Level III sedation is the degree of alertness of the patient. At Level II sedation, the patient must be able to respond to verbal and/or tactile stimuli. If a patient's only response is a reflexive withdrawal from a pain stimulus, the patient is sedated beyond Level II. A primary indication that a patient has slipped from Level II to Level III sedation is the loss of the ability to breathe without assistance, and the patient's airway must be partially or totally managed. In Level II sedation, the need for management of the airway is minimal compared to that required at Level III sedation. P.L.'s blood pressure, pulse rate, oxygenation, and mental state were consistent with Level II sedation until P.L. had her first seizure and all medications, except for the one- half therapeutic dose of Valium, were discontinued. She remained responsive to verbal stimuli after the second 2.5 milligram dose of Valium was given to control the seizure activity, even though she was more lethargic than normal under Level II sedation. P.L. was non-responsive when examined by Emergency Medical Services personnel, but she was breathing independently and was not at Level III sedation. Her lack of response was more likely than not the result of the seizures, after which a patient can go into a postictal state, or a trance of sleepiness.8 Dr. Edison did not violate the standard of care for office surgery in ordering the amounts and combination of drugs used to sedate P.L. because P.L. did not reach Level III sedation. In accordance with the standard of care for Level II office surgery, Ms. Hoff, as a registered nurse, was qualified to administer anesthesia to P.L., including Diprivan, Ketamine, and the other sedative drugs used in P.L.'s surgery, at the direction and under the supervision of Dr. Edison. Dosage of Lidocaine As stated above, Dr. Edison injected a dilute solution of Lidocaine with epinephrine and marcaine into the tissue around P.L.'s breasts between 8:25 a.m. and 8:45 a.m., before P.L. had her first seizure at 8:45 a.m. Lidocaine is a local anesthetic used to numb nerves and tissue. In breast augmentation surgery Dr. Edison always uses Lidocaine with epinephrine because epinephrine is a vasoconstrictor that causes intense vasoconstriction, or closing of the small blood vessels, which slows the rate of absorption of the Lidocaine and virtually eliminates bleeding at the site of surgery. Marcaine is also a local anesthetic similar to Lidocaine, but it is slow to take effect and lasts four to six hours and helps control pain after surgery is completed. Marcaine is commonly used with Lidocaine. It is Dr. Edison's practice to perform breast augmentation surgery using the tumescent infiltration technique to infuse a relatively large volume of dilute Lidocaine solution into the breast area as a local anesthetic. Dr. Edison uses this tumescent infiltration technique in breast augmentation surgery because he can deliver a large volume of Lidocaine that is evenly distributed throughout the breast area, which results in more effective pain reduction. The injection technique Dr. Edison uses for tumescent infiltration in the breast area is very specific, and it takes between 20 and 30 minutes to complete the injections. The needle cannot penetrate close to the pectoral muscle, especially in a woman as small as P.L., because of the danger of puncturing a lung. Dr. Edison injects the solution under pressure into the subcutaneous tissue between the breast and the pectoral muscle. Lidocaine is absorbed faster in areas that are highly vascular. The tissue in the aerolar space between the breast and the pectoral muscle does not contain many blood vessels, so Lidocaine injected in this tissue is absorbed more slowly than it would be if injected into highly vascular tissue. In Dr. Edison's experience, because the epinephrine in the Lidocaine solution causes intense vasoconstriction in the tissue surrounding the injection sites, the Lidocaine stays in place and numbs the area in which the surgery is to be performed. The Lidocaine solution is absorbed slowly over approximately 24 hours, and the peak serum concentration of Lidocaine occurs approximately 10 to 12 hours after it is administered. In this case, Dr. Edison prepared approximately 400 cubic centimeters of solution, which contained 700 milligrams of Lidocaine and 50 milligrams of marcaine, together with a small, non-therapeutic dose of epinephrine. According to his surgical notes, Dr. Edison began the injections of Lidocaine at 8:25 a.m. and had completed the injections by the time P.L. had the first seizure at 8:45 a.m., although it is his recollection that he had not used all of the Lidocaine solution he had prepared. Dr. Edison did not, however, record in the medical records the amount of Lidocaine solution he injected, and any remaining solution was discarded without being measured, so he does not know the dosage of Lidocaine P.L. actually received. Had he injected all of the solution, P.L. would have received approximately 14 milligrams of Lidocaine per kilogram of body weight. According to the package insert that accompanies a bottle of Lidocaine, the maximum dosage of Lidocaine without epinephrine is five milligrams per kilogram of body weight, and the maximum dosage of Lidocaine with epinephrine is seven milligrams per kilogram of body weight. There is nothing in Dr. Edison's medical records to indicate that the Lidocaine he used in P.L.'s surgery included epinephrine or that he calculated the amount of Lidocaine to administer to P.L. based on her body weight Using the maximum dosage specified on the package insert, the maximum dosage of Lidocaine without epinephrine for P.L. would have been 215 milligrams, and the maximum dosage of Lidocaine with epinephrine would have been 301 milligrams, using the traditional method of administering the drug. Based on the standard established by the package insert, Dr. Edison exceeded the maximum dosage of Lidocaine with epinephrine injected into P.L. by approximately 400 milligrams, which constituted a toxic dose of Lidocaine when measured by the maximum dosage stated on the package insert. The maximum dosage of Lidocaine with epinephrine stated on the package insert is routinely exceeded by surgeons performing liposuction, which involves suctioning fatty tissue. The tumescent infiltration technique using Lidocaine with epinephrine in a dilute solution is commonly used with liposuction, and Florida Administrative Code Rule 64B8- 9.009(2)(d), which sets out the standards of care for office surgery, specifically provides that a "maximum of fifty (50) mg/kg of Lidocaine can be injected for tumescent liposuction in the office setting." Large dosages of Lidocaine can be safely used in liposuction because Lidocaine is metabolized more slowly by fatty tissue than by muscle or skin, and approximately 20% of the Lidocaine solution is suctioned out of the body with the fat that is aspirated during liposuction. As a result, it is possible to administer what would otherwise be toxic doses of Lidocaine under the maximum dosages specified in the package insert. Dr. Edison has used the tumescent infiltration technique many times in performing breast augmentations without his patients' suffering any ill effects. There is, however, no rule in Florida equivalent to that relating to liposuction that permits the use of high dosages of Lidocaine as local anesthetic in breast augmentation surgery. Furthermore, Dr. Edison has failed to submit persuasive evidence of a standard of care in Florida among plastic surgeons that would permit the use of dosages of Lidocaine with epinephrine in excess of the seven milligrams per kilogram specified on the package insert for breast augmentation surgery.9 Dr. Edison violated the standard of care by injecting approximately of 700 milligrams of Lidocaine with epinephrine into the tissue surrounding P.L.'s breasts when the maximum allowable dosage, according to the insert packaged with the drug and based on P.L.'s weight, was approximately 300 milligrams. Dr. Edison's previous discipline10 Dr. Edison was charged in an Administrative Complaint dated February 21, 1995, with having committed medical malpractice in violation of Section 458.331(1)(t), Florida Statutes. He executed a Consent Agreement in which he neither admitted nor denied the factual allegations in the complaint but agreed that, if proven, the facts would constitute a violation of Section 458.331(1)(t), Florida Statutes. The Agency for Health Care Administration entered a Final Order dated August 20, 1995, adopting the Consent Agreement in relevant part. This Final Order does not establish that Dr. Edison committed a violation of Section 458.331(1)(t), Florida Statutes. In a Final Order entered January 4, 2007, the Board adopted the recommended disposition in the Recommended Order in Department of Health, Board of Medicine v. Richard B. Edison, M.D., DOAH Case No. 06-0598PL (Recommended Order August 25, 2006), that Dr. Edison be found guilty of a single violation of Section 458.331(1)(m), 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 Dismissing Counts Three and Four of the Administrative Complaint; Finding Dr. Edison guilty of a single violation of Section 458.331(1)(m), Florida Statutes, and of two violations of Section 458.331(1)(t)1., Florida Statutes; Suspending Dr. Edison's license for a period of 90 days, followed by four years' probation under such terms as shall be imposed by the Board; and Imposing an administrative fine in the amount of $15,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S PATRICIA M. HART 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 1st day of May, 2007.
The Issue Whether Respondent violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and, if so, what discipline should be imposed.
Findings Of Fact The Department is charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2003). Dr. Dangl, whose address of record is 3900 Clark Road, Suite F-1, Sarasota, Florida 34233, was issued Florida license number ME 71286. On or before September 25, 2003, Dr. Dangl's office was approved to perform Level II Office surgical procedures by the Department. In a Level II Office surgery, "the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation." Fla. Admin. Code R. 648-9.009(4). Patient J.R., a 38-year-old female, presented to Dr. Dangl on September 25, 2003, for the removal of existing breast implants and the placement of larger saline implants. The surgery was scheduled to take place in Dr. Dangl's office. The surgical team consisted of Dr. Dangl; Amanda Fortner, R.N.; and Bruce Crow. Ms. Fortner assisted Dr. Dangl in administering anesthetic agents and other controlled substances, and monitored J.R. during the procedure. Her duties included documenting J.R.'s vital signs and the types and quantities of medications that were administered. A cardiac respiratory monitor, a pulse oximeter, and a blood pressure monitor were devices used to monitor J.R. during the surgery. A cardiac respiratory monitor records the heart rate, respirations, and the sinus rhythm of the heart. The oxygen saturation in the blood is measured by the pulse oximeter, which is placed on one of the patient's fingers. Blood pressure is monitored by the blood pressure machine. Bruce Crow was the surgical technician. During the surgical procedure, he made sure supplies and surgical instruments were ready, maintained the sterile field, and assisted Dr. Dangl with the procedure. At approximately 9:15 a.m. on September 25, 2003, Dr. Dangl started an IV in J.R.'s left hand and administered the following medications: one gram of Rocephin, 20 milligrams of Reglan, 50 milligrams of Demerol, ten milligrams of Valium, 25 milligrams of Ketamine and Versed. Dr. Dangl gave the initial medications, and Ms. Fortner administered additional drugs pursuant to Dr. Dangl's orders. J.R. was given an additional 200 milligrams of Demerol. The last dose of Demerol was administered by Ms. Fortner at 9:50 a.m. J.R. was a small person, and, for her weight and size, it took an unusual amount of Demerol to get J.R. sedated. Versed and Valium are sedative hypnotics, which sedate patients and cause them to become sleepy. Demerol is an analgesic, a pain medication. These medications can decrease respiration. Ketamine is a dissociate anesthetic, which does not cause respiratory depression. J.R. was also given a Propofol drip IV to help keep J.R. asleep. Propofol is a general anesthetic which depresses brain cells. The Propofol was mixed with a saline solution at a rate of one 55 cc vial per 100 cc's of saline. Ms. Fortner prepared the solution, which was initially administered by Dr. Dangl until he got it to the rate that he wanted. Once the surgery started, he would tell Ms. Fortner to speed-up or slow- down the drip as necessary. Three bottles of Propofol were used during the surgical procedure. J.R. was also given two liters of oxygen during the procedure. An oral airway was inserted into J.R.'s mouth during the early stages of the procedure. An oral airway is a long device that is inserted behind the tongue and goes deep into the patient's throat. In order to tolerate an oral airway, the patient would have to be in a deep level of sedation. J.R. was awake when the medications were started. She continued to talk through at least half of the time the medications were being administered. At one point during the surgery, J.R. "moaned a little bit, but then went right back to sleep." During the surgical procedure, Dr. Dangl sat J.R. up approximately three times to check the symmetry of the implants. J.R. continued to sleep through these checks. During the last time that J.R. was brought to a sitting position at approximately 11:55 a.m., the pulse oximeter alarmed. Thinking that the device may have fallen off J.R.'s finger, Ms. Fortner checked the device and also checked to make sure that the oximeter was not on the arm on which the blood pressure machine was placed. The pulse oximeter was on the correct finger. Ms. Fortner advised Dr. Dangl that something was wrong. She turned up the oxygen and placed an Ambu bag1 over the oral airway which had been placed in J.R.'s mouth at the beginning of the case. Ms. Fortner started Ambu bagging J.R. At Dr. Dangl's direction, Ms. Fortner turned off the Propofol drip. However, J.R.'s pulse oximeter reading did not improve. Not wanting to break the sterile field, Dr. Dangl yelled at Ms. Fortner, "Don't make me come back there and help your ass." When J.R. still did not improve, Dr. Dangl broke the sterile field, pushed Ms. Fortner aside, and began to Ambu bag J.R. Dr. Dangl checked J.R. for a pulse, but was unable to find one. Ms. Fortner checked for a pulse and thought that she may have found a faint pulse. Dr. Dangl, hearing the receptionist in the hallway, called to her to get Michelle Purdy, another employee of Dr. Dangl. The receptionist went to get Ms. Purdy and came back saying that Ms. Purdy was on the telephone. Dr. Dangl told the receptionist to get Ms. Purdy. Ms. Purdy, who is not a nurse, came into the operating area and tried to find a pulse for J.R. Unfortunately, Ms. Purdy tried to find a pulse using her thumbs. After being corrected by the surgical team, Ms. Purdy attempted to locate a pulse in the brachial, then the femoral, and then the pedal pulses, but she was unable to find a pulse. After being unable to locate a pulse, Dr. Dangl instructed one of his staff to call for emergency medical services (EMS). While Dr. Dangl and his employees were searching for a pulse, the surgical technician asked for leave to begin chest compressions. Mr. Crow told Dr. Dangl that the heart rate monitor was flat lining, meaning that it showed no basic heart rhythm for J.R. J.R.'s skin was gray and her fingers were turning blue. Dr. Dangl told Mr. Crow to wait. Dr. Dangl instructed Ms. Fortner to give J.R. three milligrams of Atropine two times. Ms. Fortner complied with his orders, but J.R. still had not started to breathe again. Mr. Crow continued to request Dr. Dangl to allow him to start chest compressions. After the administration of the Atropine failed to revive J.R., Dr. Dangl allowed Mr. Crow to begin chest compressions. From a minimum of two minutes to a maximum six minutes2 elapsed between the time Mr. Crow first asked to do chest compressions and when he began to do chest compressions. While chest compressions were being administered, Dr. Dangl ordered Ms. Fortner to administer Epinephrine to J.R. While Dr. Dangl continued to Ambu bag J.R., Mr. Crow administered three cycles of chest compressions. A cycle is 15 chest compressions to two Ambu breaths. J.R.'s heart rate returned and J.R. developed tachycardia, which means a high heart rate. About the time that J.R. revived and became stable, the paramedics arrived. J.R. was breathing, had a heart rate, and had a pulse oximeter reading of approximately 98. Neither the paramedics nor Dr. Dangl or any of his staff checked J.R.'s pupils. When the paramedics arrived, the surgery was not completed. The paramedics informed Dr. Dangl that another EMS team was on the way. Dr. Dangl and the paramedics agreed that Dr. Dangl could finish closing and suturing the wound, while waiting for the other EMS team to come and transport J.R. to the hospital. The paramedics stayed for a short time in the operating area monitoring J.R.'s vital signs and then left to make copies of J.R.'s chart, leaving Ms. Fortner to continue the monitoring of the vital signs. While Dr. Dangl was completing the procedure, J.R.'s vital signs were within normal range. Ms. Fortner periodically checked J.R.'s breathing by placing her hand over J.R.'s mouth. After Dr. Dangl completed suturing the wound, the second team of paramedics came into the operating area to transport J.R. The paramedics examined J.R.'s eyes, which were fixed and dilated. The paramedics immediately intubated J.R. and took her to the hospital. While at the hospital, Dr. Dangl admitted to J.R.'s fiancée that he had given J.R. "a lot of medication for her body size and weight," but that he thought J.R. was metabolizing the anesthetic very quickly. J.R. never regained consciousness after she was transported to the hospital. She died several months later from hypoxic encephalopathy, which means low oxygen brain damage. On September 26, 2003, Dr. Dangl dictated a report of operation. His documentation of J.R.'s "cardiorespiratory event" is as follows: Immediately prior to closure, the patient experienced a cardiorespiratory event that required CPR and resuscitative efforts. The EMS was activated and assumed care of the patient upon arrival. At this time the patient had responded to the resuscitative effort, vital signs were stable and permission was given by EMS to complete closure of the incisions prior to transport. The incisions were closed in a layered fashion with 3-0 PDS II and 5-0 nylon. A sterile dressing was placed over the incision sites. The patient was entubated [sic] by EMS prior to transport and left the O.R. via ambulance for Doctor's Hospital Emergency Room. Dr. Dangl signed a document entitled, "Operating Room Record." The record contained a section in which the medications that were administered should have been listed along with the time administered, the dosage, and the method of administration. That section of the record contained the following, "see anesthesia record," in lieu of listing the medications. The anesthesia record which was prepared by Ms. Fortner did not list all the medications that were administered to J.R. such as the Atropine and Epinephrine. She did not list the amount of Lidocaine or Propofol that was administered. It should have been obvious to Dr. Dangl when he reviewed the anesthesia report, that it was not correct. When Dr. Dangl prepared the Report of Operation and signed the Operating Room Record, he should have included the medications which he ordered and which were not included in the anesthesia report. Both Dr. Dangl and Ms. Fortner were certified in Advanced Cardiac Life Support at the time of the surgery. Ms. Fortner is not an anesthesiologist, a certified registered nurse anesthetist, or a physician assistant. Based on the testimony of Ms. Fortner that three 50 cc bottles of Propofol were used during the surgery, Dr. Joan Christie calculated that the dosage of Propofol that was administered was between 160 and 170 micrograms per kilo per minute. In a normal patient, who has received no other drugs, 100 micrograms per kilo per minute would be a lot of medication. J.R. received between 160 and 170 micrograms per kilo per minute on top of the other drugs that had been administered to her at the beginning of the procedure. The Propofol was administered in excessive amounts. Based on the evidence presented, it is clear that J.R. went from a Level II to a Level III office surgery during the surgical procedure. She tolerated an oral airway, which she could not do under a Level II or Level I. She was not responding purposefully to verbal commands or tactile stimulation. When J.R. was sat up to check the symmetry of her implants, she did not wake up or otherwise respond. Although she did moan at one time during the surgical procedure, that did not mean that she was either at Level I or Level II. Dr. Dangl has had no prior disciplinary actions taken against him by the Department.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and revoking his license to practice medicine. DONE AND ENTERED this 23rd day of February, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of February, 2005.
