The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Witherspoon is a 41-year-old police officer. He has worked in law enforcement for 20 years and is currently employed as a police officer for the City of Fort Lauderdale. Witherspoon was injured in an employment-related accident on September 14, 1999. The accident significantly aggravated a pre-existing injury to his left knee. At the time of the accident, Witherspoon had already had two arthroscopic surgical procedures to treat his pre- existing knee injury. He underwent a third arthroscopic surgery following the accident, and returned to work in the Spring of 2000. In addition to surgery and physical therapy, Witherspoon has been treated continuously with injections and medications in an effort to alleviate his symptoms, to no avail. At all times relevant to this case, Witherspoon has two separate injuries to the articular cartilage of his knee: one in the trochlea and one in the medial femoral condyle. Because of these injuries, Witherspoon's articular cartilage, which is necessary for proper functioning of the knee joint, has been degrading and flaking off and will continue to do so. The injuries cause him to walk with a significant limp. He is in constant pain and constant danger of his knee buckling. Witherspoon's situation is complicated by a defect in the articular cartilage of his patella. ACI was not recommended for this defect, and it is unknown how debilitating the patella injury would continue to be, if and when ACI treatment is successfully completed. Because of his injuries, Witherspoon is unable to perform the duties of a uniformed police officer. He is presently assigned to desk work, at a significantly reduced salary. Witherspoon is on an accelerated course to advanced degenerative arthritis, for which a complete knee replacement is the standard recommended treatment. Because Witherspoon is relatively young and knee replacements do not last indefinitely, the unanimous weight of medical opinion is that knee replacement should be postponed as long as possible. Witherspoon's treating physician, having exhausted all viable treatment options, referred Witherspoon to Dr. Douglas Stringham (Stringham), a Board-certified orthopedic surgeon. After reviewing Witherspoon's arthroscopic photographs and medical records, Stringham recommended that he undergo ACI. Witherspoon requested authorization for the ACI procedure, which was denied by his Employer/Carrier City of Fort Lauderdale (Employer). The dispute was referred to AHCA for review in accordance with Subsection 440.13(1)(m), Florida Statutes. AHCA consulted with Dr. Peter Indelicato (Indelicato), a Board-certified orthopedic surgeon. Indelicato rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. He further opined that there was not reliable evidence that ACI would provide significant benefit to Witherspoon's recovery and well being within the meaning of Rule 59B- 11.004(3), Florida Administrative Code. Relying exclusively upon Indelicato’s opinion, AHCA declined to order the Employer to provide ACI to the Petitioner. Upon the filing of this petition, Witherspoon was advised by the Employer that neither ACI nor any other form of intervention would be offered to him. AHCA has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Subsection 440.13, Florida Statutes. The ACI procedure which has been recommended to Witherspoon was initially developed in Sweden. Over the course of two separate surgical procedures, a sample of cartilage is first harvested arthroscopically from another area of the patient's knee joint. The sample is sent to the Boston Laboratory of Genzyme Tissue Repair, Inc. (“Genzyme”), which owns the rights to the process. Genzyme uses its proprietary process to culture the cells into an estimated five million chondrocytes over a period of approximately five weeks. Genzyme returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted in the wounded cartilage and covered with the periosteal flap. The claimed benefit of ACI is that the cartilage that is generated and implanted into the knee will approximate natural human cartilage to an extent significant enough to provide substantial benefit to the patient. Because ACI is in its infancy, questions remain about the long-term efficacy of the procedure. Other available treatments for a defect in articular cartilage of the knee include, abrasion chondroplasty, arthroscopic microfracture or drilling, osteochondral autograft surgery or “plugs”, and an osteochondral allograft using transplanted tissue from a cadaver (collectively, "conventional interventions"). Each of these procedures is, standing alone, less expensive than ACI. Each of these procedures, whether used singly or in combination, is not appropriate for Witherspoon at this time. Individually and collectively, conventional interventions afford no realistic hope of providing any noticeable relief for his symptoms, nor will they forestall the deterioration of his knee. The evidence establishes that there are no viable alternatives to ACI in the facts and circumstances of this case. Witherspoon is either not a candidate for conventional interventions, or has had such treatments and they have failed. Of the three Board-certified orthopedic surgeons who testified, AHCA's expert, who has never performed ACI, opined that Witherspoon could be treated by conventional interventions and Witherspoon's experts, who do perform ACI, testified that conventional interventions have failed and will continue to fail. There is no evidence to suggest that the testimony of any of the doctors was tainted by personal financial considerations of any kind. The ACI procedure, if successful, would be less expensive than a continuing course of short-term "housekeeping" treatments. Conventional interventions would, at most, stave off the inevitable knee replacement. They would not alleviate Witherspoon's disability in any way. Reliable evidence establishes that the ACI procedure presents the only possibility of providing Witherspoon with significant benefits toward recovery and well being. AHCA stipulates and the evidence establishes that ACI has been established to be safe. Under the facts and circumstances of this case, the benefits of the ACI procedure outweigh the risks to Witherspoon.
Recommendation Based upon the foregoing, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order approving the proposed ACI for the Petitioner. DONE AND ENTERED this 24th day of April, 2001, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 24th day of April, 2001. COPIES FURNISHED: Barry A. Pemsler, Esquire 307 Ros Centre 770 Ponce de Leon Boulevard Coral Gables, Florida 33134 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Mail Stop 3 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
The Issue The issue for determination in this proceeding is whether the Respondent, the Department of Professional Regulation, should pay the Petitioner, Kirk A. Woodson, M.D., attorney fees and costs under Section 57.011, Fla. Stat. (1989), the Florida Equal Access to Justice Act. As reflected in the Preliminary Statement, the parties stipulate that the Petitioner is a "prevailing small business party" and that reasonable fees and costs exceed $15,000, the statutory cap. The only remaining issue under the statute is whether the Respondent was "substantially justified" in filing the Administrative Complaint in Case No. 90- 5986 against the Petitioner. 1/
Findings Of Fact On or about June 7, 1988, a complaint was filed against the license of the Petitioner, Kirk A. Woodson, M.D., subsequent to closure of a professional malpractice liability claim against him without payment of indemnity. The substance of the complaint was that, on January 1, 1986, Woodson saw and performed a hysterectomy on a patient who had presented at the emergency room at University Community Hospital in Tampa, Florida, with heavy and continuous vaginal bleeding. The complaint stated that post-surgery the patient developed Adult Respiratory Distress Syndrome (ARDS) and died. The complaint questioned whether Woodson failed to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. By letter dated June 30, 1988, the Department of Professional Regulation (the Department or DPR) notified Woodson that it had received the complaint and that it was initiating an investigation. DPR subpoenaed the hospital records which revealed that the patient arrived at the UCH emergency room at 5:28 a.m. on January 1, 1986, with at least a three-day history of vaginal hemorraging. An emergency room physician saw the patient, gave her two units of packed blood cells, and admitted her to Woodson's service. Woodson was called at approximately 8:30 a.m. and saw the patient later that morning. The patient's admission to surgery to determine the cause of the bleeding and perform necessary procedures was delayed until at least approximately 2:00 p.m. because the patient refused to consent to a dilation and curettage (D and C); she was insisting on a hysterectomy only. She finally consented to a D and C to be followed by a hysterectomy if Woodson found it to be medically necessary. During this delay, the patient continued to bleed and was transfused with two more units of packed blood cells at approximately 1:45 p.m. After the consent was given, there was a further delay, not explained by the records, until approximately 6:00 p.m. in getting the patient to surgery. The patient continued to bleed. Surgery took almost five hours. During surgery, the patient's bleeding got worse, and she was transfused with four more units of whole blood during the surgery. The DPR investigator was unable to ascertain from the hospital records the reason for the length of the surgery. The DPR investigator attempted to arrange an interview with Dr. Woodson and his attorney on or about February 28, 1989. The appointment was cancelled. When the DPR investigator contacted Woodson to reschedule the interview, Dr. Woodson questioned why DPR was pursuing the complaint when the malpractice claim was closed without payment of indemnity. Dr. Woodson agreed to be interviewed but expressed his preference that the investigator first review the "extensive depositions" taken in the malpractice litigation. 4/ Having already determined to request an expert evaluation of the case, the investigator decided to postpone the interview with Dr. Woodson. On July 10, 1989, the DPR asked a probable cause panel of the Board of Medicine to authorize the retention of an expert in gynecology to review the information obtained through investigation to that point in time to assist in the determination whether Woodson's treatment of the patient fell below that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. On July 22, 1989, the probable cause met and authorized the expert review. On or about November 2, 1989, the DPR requested an expert review by Doris N. Carson, M.D., a Board-certified gynecologist with extensive surgical experience, including emergency room experience. Dr. Carson reviewed the hospital records supplied by DPR, some of which were difficult to read. By letter dated November 20, 1989, Dr. Carson reported her impressions. Dr. Carson believed the records supported Dr. Woodson's diagnosis and ultimate course of treatment. In the patient's condition, the proper course of treatment was to attempt to stop the vaginal bleeding by doing a D and C; a hysterectomy only should have been attempted if the D and C did not stop the bleeding. However, Dr. Carson perceived other problems that were not explained to her satisfaction by the hospital records. First, Dr. Carson did not see anything in the records to justify the length of the surgical procedures performed by Dr. Woodson. She reported: Careful review indicated that the subject attempted to remove the fibroids vaginally, and when this only increased the bleeding, then decided to do a laparotomy. The uterus, although enlarged, was not huge and the procedure as described seemed to move along without difficulty. When, however, the time is reviewed five hours would indicate very serious problems of technique or what seems more likely a lot if indecision about how to proceed. Evidently there was no physician surgical assistant, and the subject proceeded alone. In retrospect better operationg room help should have been available. Second, Dr. Carson felt that the patient received too much whole blood replacement during the course of the day and the surgery. Her reading of the hospital records indicated to her that five units of whole blood were given to the patient in addition to four units of packed cells. She felt: "Packed cells altogether would have been a better choice in light of the volume given to the patient." Her concern was that "volume overload," rather than ARDS, may have resulted ultimately in the death of the patient. However, she disclaimed the necessary expertise to render a conclusive opinion on the question and recommended that, if the DPR wanted a conclusive opinion on the cause of death, it should have a specialist in intensive care or a respiratory expert review the records. Dr. Carson had some difficulty with the delay in getting the patient to the operating room. The records indicated that at least some of the delay was caused by the patient's unwillingness to give consent to the recommended D and C. But Dr. Carson nonetheless had concerns that the delay added to the amount of blood transfused. Dr. Carson closed her letter with this remark: "In conclusion: A poorly done sugical proceeding below the recognized normal level of care." For reasons not apparent from the evidence presented, DPR did not interview Dr. Woodson before asking the probable cause panel to find probable cause and file a draft Administrative Complaint against Dr. Woodson based on Dr. Carson's expert review and the rest of the investigative report, including the hospital records. The draft Administrative Complaint, drawn in two counts, sought to discipline Dr. Woodson under Count I for failure to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances, in two respects: first, for allegedly causing volume overload in the patient by ordering units of whole blood, instead of packed blood, to replace the patient's blood loss; and, second, for allegedly taking too long, without justification, to perform the necessary surgery. Count II alleged that Woodson failed to keep written medical records justifying the course of treatment of the patient, specifically with respect to ordering whole blood instead of packed units and with respect to the length of the surgical procedures. The probable cause panel considered the matter at its meeting on June 22, 1990. Counsel for the panel pointed out that the "extensive depositions" Woodson had indicated he wanted the DPR investigator to read before Woodson was interviewed were not in the packet of materials reviewed by the panel. 5/ But members of the panel indicated that they had reviewed the material that was in the packet and that they thought the information contained in it was adequate to make a probable cause determination. One of the doctors on the panel called it a "horrendous case." She felt that Woodson had "swamped out the patient" and had performed "inappropriate types of fluid therapy and blood therapy." The other member mentioned the "five-hour operating time . . . without any real explanation." The panel's attorney pointed out the part of the report of investigation that referenced the patient's refusal to consent to Dr. Woodson's proposed surgery and asked whether it constituted "any semblance of an explanation for a delay?" It is not clear from the transcript of the probable cause proceeding how the panel resolved the attorney's question, but the panel voted to find probable cause notwithstanding the question. 6/ There is information in the materials reviewed by Dr. Carson, and by the probable cause panel, which tends to explain some of the time it took for Dr. Woodson to perform surgery on the patient. Some of this partially exculpatory information was difficult to read and decipher in the records. Some of the partially exculpatory information was acknowledged by Dr. Carson and may also have been taken into account independently by the panel. Notwithstanding this partially exculpatory information in the record, the finding of probable cause was substantially justified.
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes (2001),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. Dr. Dangl, whose address of record is 3900 Clark Road, Suite E-1, Sarasota, Florida 34233, was issued Florida license number ME 71286 to practice medicine in Florida. During all relevant periods of time, he was not board-certified by the American Board of Medical Specialties or by any agency recognized by the Board of Medicine. Dr. Dangl is the holder of a D.M.D. degree from the Washington University School of Dental Medicine in St. Louis, Missouri. He is not licensed as a dentist in Florida, but he has previously held dental licenses in Missouri, Pennsylvania, and Virginia. He is specialty certified by the American Board of Oral and Maxillofacial Surgery. This specialty is related to the practice of dentistry. During all relevant periods of time, Dr. Dangl's office was fully and properly registered as an office surgical facility. During all relevant periods of time, Dr. Dangl did not have hospital privileges. On August 17, 2001, C.S., a female who was at that time 63 years old, came to Dr. Dangl's office for a consultation regarding facial rejuvenation and body contouring. Dr. Dangl saw C.S. and recommended "that she consider cervicofacial rhytidectomy with full face carbon dioxide laser resurfacing and autogenous fat transfer to the facial area." He further determined that the "degree of liposity in the abdomen and flanks is minimal and this can also be treated at the same time with low-volume tumescent liposuction." Prior to her consultation with Dr. Dangl, C.S. had seen an advertisement for Dr. Dangl in the "Sarasota Herald-Tribune." The advertisement listed Dr. Dangl as "Kurt Dangl, M.D., FAACS" and underneath his name appeared the words "Board Certified." From reading the advertisement, C.S. assumed that Dr. Dangl was board-certified in cosmetic or plastic surgery. C.S. returned to Dr. Dangl's office on August 21, 2001, for preoperative counseling. She signed consent forms for the procedures to be performed. The consent forms listed potential risks and complications involved with the procedures. Complications included infection, wound breakdown, and skin necrosis. The consent forms stated that Dr. Dangl did not guarantee specific results and that wound healing was outside the control of the patient and Dr. Dangl. On the printed consent forms the abbreviation "D.M.D." followed Dr. Dangl's name. No evidence was presented that the consent forms were being used as advertisements. C.S.'s medical records in Dr. Dangl's files indicate a blood sample was taken from C.S. on August 21, 2001, and sent to AccuLab. An AccuLab report dated August 22, 2001, indicated that C.S. had a slightly lowered hemoglobin level of 35.5. Based on a notation on the report, it appeared that Dr. Dangl reviewed the report on August 23, 2001. There is a handwritten note on the AccuLab report that the hemoglobin count was "ok for planned procedure." Dr. Dangl did not advise C.S. prior to the surgical procedures that her hemoglobin count was low. Dr. Dangl's records indicate that C.S. gave a medical history prior to the surgery and that Dr. Dangl performed a physical examination of C.S. prior to the surgery. C.S. advised Dr. Dangl that she had had her coccyx removed about six weeks before her scheduled cosmetic surgery. On August 28, 2001, C.S. returned to Dr. Dangl's office to have Dr. Dangl perform a face and neck lift, laser resurfacing of the face, removing fat from her abdomen and flanks, and transferring some of the fat from the abdomen and flanks to specific areas in her face. Betsy Shecter, who is licensed as an advance registered nurse practitioner in Florida, was the nurse anesthetist for C.S.'s procedures. Ms. Shecter's first contact with C.S. on August 28, 2001, occurred at 13:05, when she interviewed C.S. and then escorted C.S. to the operating room. At 13:15, C.S. was given valium, and an IV infusion of propofol and Sufenta was placed in C.S.'s arm around 13:20. Propofol is an anesthetic and Sufenta is a synthetic narcotic. C.S. was prepped and draped around 13:30, and a local anesthesia was injected at 13:35. Because the local anesthesia required about 20 to 30 minutes to become active, Dr. Dangl did not make the first incision until 14:05. The liposuction procedure to harvest the fat for a fat transfer occurred between 14:05 and 15:00. After liposuction, a local anesthesia was injected in the areas where the face lift would be performed. At 15:20, a garment was applied to the areas where fat had been harvested to keep the swelling down. Sequential leg compressions were put in place to avoid blood clots. The actual face lift started around 15:30 and ended around 20:20, when Ms. Shecter put Opticane ointment and corneal shields in C.S.'s eyes for the laser procedure. The laser procedure began around 20:25. At around 21:00, Ms. Schecter turned off the propofol drip to which Demerol had been added. The actual laser surgery stopped at approximately 20:55. The eye shields were removed at 21:15. The recovery time in the operating room commenced at 21:00 when the drugs were stopped and ended around 21:45. The recovery time continued until C.S. was discharged at 22:30. At the time of her discharge, C.S.'s vital signs were stable, and she was alert and oriented. C.S. was told prior to the surgery that someone would have to stay with her overnight after the surgery. C.S. made arrangements for her daughter and C.S.'s sister to stay overnight with her. C.S.'s sister had training and experience as a certified nurse assistant. Prior to the surgery, Dr. Dangl told C.S. that she would probably be ready to go home around four or five o'clock (16:00 or 17:00). She made arrangements with her daughter to pick her up around 17:00. When her daughter inquired from Dr. Dangl's office at 17:00 whether her mother was ready to leave, she was advised that surgery had not been completed. C.S. was not discharged until over five hours after her daughter first contacted Dr. Dangl's office. C.S.'s daughter became visibly upset when she saw her mother after the surgery and wanted to have C.S. admitted to a hospital. Because of the daughter's agitation, arrangements were made for a licensed practical nurse, Ruth Schneider, to stay overnight with C.S. C.S.'s daughter and sister had some difficulty in getting C.S. into the car for the trip home because of the sequential leg compressions, which C.S. wore home. Dr. Dangl and Ms. Shecter put C.S. in the car. At the time that C.S. was put in the car, C.S. was able to stand on her own and able to walk with support. When C.S. arrived home, Ms. Schneider assisted C.S. into her home. At that time, C.S. was alert and oriented and could ambulate with assistance. When C.S. got in her home, she was able to drink and take nourishment. Ms. Schneider helped C.S. ambulate to the bathroom. C.S. sat in a recliner and slept some during the night. At the close of Ms. Schneider's eight- hour shift, she left C.S. in the care of C.S.'s sister. C.S. was scheduled for a follow-up visit with Dr. Dangl on August 29, 2001, but C.S.'s sister was unable to arouse C.S. and get C.S. up to go to the doctor's office. Dr. Dangl's office was advised that C.S. could not come to his office. Dr. Dangl came to C.S.'s home around nine or ten o'clock in the evening of August 29, 2001, for a follow-up visit. He removed the dressings from her wounds and applied an antibiotic ointment. Dr. Dangl apparently did not have bandages with him that he could place on the surface of the wounds because he asked the sister for sanitary napkins to use as a dressing. C.S.'s sister retrieved sanitary napkins from the bathroom, and Dr. Dangl, using scissors from a nearby basket, cut the napkins up and used them to dress the wounds. He reused the Ace-type bandages which he had removed and placed them over the sanitary pads. C.S. was instructed to come to Dr. Dangl's office on August 31, 2001, for her 72-hour postoperative evaluation. On August 31, 2001, C.S.'s sister took C.S. to Dr. Dangl's office. C.S.'s sister did not accompany C.S. into the treatment room. Dr. Dangl removed the dressings and inspected the wounds. There was no evidence of hematoma, seroma, or infection. He noted that there was a "small area of devascularization immediately anterior to the left tragus on the left side" and described the areas as "about the size of a quarter." His notes indicate that the area would be "followed expectantly and debrided as necessary." He was to follow up with C.S. in 48 or 72 hours. When Dr. Dangl came out of the treatment room, he saw C.S.'s sister and asked her what was wrong with her. She explained that she was tired from being up all night with C.S. Dr. Dangl asked the sister why she did not take one of the sleeping pills that he had prescribed for C.S. The sister replied, "What? Why would you tell me to do that, take someone else's medicine?" Prior to this conversation, Dr. Dangl had not examined the sister in any way, gotten her medical history, or asked her whether she was taking any other medications. Over the next several days, C.S. complained to her sister that she was burning, hurting all over, and was not able to sleep or rest. On September 3, 2001, C.S.'s daughter called Dr. Dangl's office and advised that C.S. had a foul smelling discharge in front of her left tragus. Dr. Dangl called in a prescription for antibiotics for C.S. and told C.S.'s daughter that he wanted to see C.S. the following day. Dr. Dangl saw C.S. in his office on September 4, 2001. His examination of C.S. revealed that the size of the devascularized area in front of her left tragus had increased four times. There was some foul smelling yellow-brown discharge coming from this area as well as from several areas under the mandible approximately following the locations of the previously placed drains. He debrided the devitalized area and irrigated the discharge areas with an antibiotic solution and hydrogen peroxide. An intravenous antibiotic was administered, and wound cultures were obtained from various sites. Dr. Dangl again saw C.S. in his office on the evening of September 4, 2005. There was a minimal amount of drainage and no foul smelling odor. On September 5, 2001, C.S. again presented to Dr. Dangl's office for postoperative infection evaluation and treatment. There was a mild purulent discharge in the left anterior neck and at the left post auricular area. Dr. Dangl debrided the wound area and irrigated the wound area with sterile saline. C.S.'s pain medication was increased. Dr. Dangl saw C.S. in his office on September 6, 2001, for further wound treatment. The laboratory results of the wound cultures indicated a light growth of E. coli. Dr. Dangl administered an antibiotic intravenously and removed necrotic tissue. C.S. returned to Dr. Dangl's office on September 7, 2001. Her temperature was 100.6 degrees Fahrenheit, and she was complaining of significant discomfort. Dr. Dangl debrided the wound area. He examined the abdomen and flank incisions and found no evidence of infection or other signs of untoward wound healing. C.S.'s daughter accompanied her mother to Dr. Dangl's office on September 7, 2001, and expressed her concerns about her mother's condition. The daughter felt that her mother might benefit from hospitalization. Dr. Dangl referred C.S. to Dr. Manual Gordillo for evaluation and determination of the need for hospitalization. Dr. Gordillo treated infectious diseases. Dr. Gordillo saw C.S. and advised C.S. and her daughter that the treatment for the infection could be done in the hospital or on an outpatient basis, but expressed his opinion that admission to the hospital was borderline. C.S. opted for hospitalization and was admitted to Doctors Hospital of Sarasota on September 7, 2001. After C.S. was admitted to the hospital, additional cultures were taken of the wound sites as well as the sites in the abdomen where fat had been harvested. Based on the laboratory results, C.S. had a scant growth of E. coli from her face wound culture and a moderate growth of staphylococcus aureus from abdominal wound culture. C.S. was placed in isolation because of the staph infection. C.S. was experiencing a great deal of pain from her wounds while she was in the hospital. Because of her difficulty with pain management, she was put on a PCP pump to help control the pain. While she was in the hospital, Dr. Dangl visited her several times to observe. He did not perform any treatment on C.S. while she was hospitalized. C.S. told Dr. Dangl that she wished that he would not visit her while she was in the hospital, but he continued to come. The evidence is not clear and convincing that C.S. conveyed to Dr. Dangl that she did not want his services any longer, particularly in light of C.S.'s paying office visits to Dr. Dangl for treatment after she was discharged from the hospital. However, the evidence is clear and convincing that C.S. did not want Dr. Dangl to visit her in the hospital and that she told him so. Dr. Dangl's medical records do not establish a medical basis for continuing to see C.S. in the hospital after she asked him not to do so. C.S. was discharged from the hospital on September 13, 2001. At that time, she was feeling much better, her wounds were stable, and her wounds were not clinically overtly infected. She was directed to follow up with Dr. Dangl as soon as the following day and to follow up with Dr. Gordillo within a week. After her discharge from the hospital, C.S. continued to see Dr. Dangl on September 15, 17, 19, and 21, 2001. Dr. Dangl changed the dressings and, on two of the visits, did some minimal debridement. C.S. discontinued seeing Dr. Dangl after her office visit on September 21, 2001. On September 24, 2001, C.S. began seeing Dr. John Leikensohn, a plastic and reconstructive surgeon, for wound treatment. He diagnosed C.S. as having massive skin necrosis. When C.S. began seeing Dr. Leikensohn, she was asked to sign a medical release for her medical records from Dr. Dangl, and she did so. Dr. Leikensohn's staff contacted Dr. Dangl's office by telephone to get C.S.'s records. The medical release was sent by facsimile transmission to Dr. Dangl's office with a request for C.S.'s records. By October 2, 2001, Dr. Leikensohn had not received the records from Dr. Dangl. Dr. Leikensohn asked C.S. and C.S.'s daughter to stop by Dr. Dangl's office and get a copy of the records. C.S. went to Dr. Dangl's office and personally asked his staff for her records, but was not given the records. She also submitted a written request for her records, but did not receive them pursuant to the written request. Barbie Beaver, Dr. Dangl's office coordinator, does not recall when or from whom she actually received a request for C.S.'s records, but she does remember sending C.S.'s medical records to Barbara Dame, Dr. Dangl's risk manager, for her review on September 27, 2001. When Dr. Dangl's office received a request for a patient's records, she would advise Dr. Dangl and he would decide what to do. She gave a request for C.S.'s medical records to Dr. Dangl, and he instructed her to send them to Ms. Dame for review prior to releasing the records. Ms. Beaver does not recall when she actually sent C.S.'s records to the person who requested them. During his treatment of C.S., Dr. Dangl wrote several prescriptions for C.S. The prescription scripts contained the abbreviation "D.M.D." after his name. No evidence was presented that the prescriptions were intended to be used for advertising purposes. Dr. John J. Obi, a board-certified plastic surgeon, testified as the Department's expert witness. It is Dr. Obi's opinion that it would have been good medical practice to have advised C.S. of her low hemoglobin prior to surgery, but that because the blood level was not dangerously low, he could not "say that's a complete deviation from the standard of care." Dr. Obi further opined that Dr. Dangl exceeded the eight-hour limitation on elective cosmetic surgery in a physician's office when he performed the procedures on C.S. on August 28, 2001. Dr. Obi's opinion is based on his incorrect understanding that the anesthesia was stopped at 22:00. Thus, even if the time for calculating surgical procedures ran from the time the anesthesia was first administered at 13:15 until it was stopped at 21:00, the length of time for the surgical procedures was seven hours and forty-five minutes. Dr. Obi opined that the recovery time for C.S. was insufficient. Again he based his opinion in part on his incorrect assumption that the anesthesia was discontinued at 22:00. Dr. Obi creditably testified that Dr. Dangl's continuing to see C.S. in the hospital after she told him that she did not want him to visit fell below the prevailing standard of care. Dr. William Frazier, the expert who testified on behalf of Dr. Dangl, gave no opinion on whether Dr. Dangl's continued hospital visits after being told not to visit by C.S. violated the standard of care. Dr. Obi opined that it was a violation of the standard of care for Dr. Dangl to tell C.S.'s sister to take some of C.S.'s prescription sleeping pills without examining or taking a medical history of the sister. Dr. Frazier was of the opinion that the conversation between Dr. Dangl and C.S.'s sister did not fall below the standard of care. Dr. Frazier's opinion was based on his misunderstanding that C.S.'s sister had asked Dr. Dangl if it was appropriate for her to take a sleeping medication that she already had.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes; finding that Dr. Dangl did not violate Subsection 458.331(1)(d), Florida Statutes; imposing an administrative fine of $2,000 for the violation of Subsection 458.331(1)(nn), Florida Statutes; imposing an administrative fine of $3,500 for violations of Subsection 458.331(1)(t), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(ll), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(m), Florida Statutes; suspending his license for two years; and requiring Dr. Dangl to attend continuing medical education classes to be specified by the Board of Medicine. DONE AND ENTERED this 16th day of August, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of August, 2005.
The Issue Should Petitioner discipline Respondent's license to practice medicine?
Findings Of Fact At the times relevant to the inquiry Petitioner was the state agency charged with regulating the practice of medicine in Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician within the state of Florida, having been issued license No. ME0045474, effective December 28, 1984. Respondent's last known address is 1401 Centerville Road, Suite 202, Tallahassee, Florida 32308. Respondent is board-certified in obstetrics and gynecology. The board certification is by the American Board of Obstetrics and Gynecology. Respondent is a fellow of the American College of Obstetricians and Gynecologists. Respondent received his undergraduate degree from Florida State University and his medical degree from Howard University. His training at Howard University included a four- year residency program from 1982 to 1986. Respondent holds staff privileges at Tallahassee Memorial Hospital (TMH) in Tallahassee, Florida. Patient A.G. Patient A.G. began treatment with Respondent in 1998 and continues as Respondent's patient. A.G. is an Hispanic female who is not proficient in English. When seen by Respondent in his office she has been accompanied by an interpreter that would allow Respondent to discuss details of her health care in English for translation into Spanish for the patient's benefit. Respondent's understanding of Spanish is limited to education in high school and a year at the university. He has the ability to describe some matters that are pertinent to gynecologic practice or obstetric practice and in particular as it relates to telling patients, for example "how to push and when not to push." The record does not reveal that Respondent has the ability to discuss A.G.'s overall health care in Spanish, her language. A.G.'s husband, T.Q., who accompanied her at relevant times principally spoke Spanish and not English. He is somewhat proficient in English. On June 16, 1999, A.G. had an office appointment with Respondent. At that time A.G. had undergone gallbladder surgery but her pelvic pain persisted. In consultation on that day it was decided that A.G. would undergo diagnostic laparoscopy to explore the reason for her chronic pelvic pain. Through the discussion the patient was told that biopsies of the pelvic anatomy might be performed during the procedure and that any problems that could be addressed through laparoscopy would be addressed as Respondent felt comfortable in carrying out that correction. Otherwise, Respondent said that he would "take pictures" and "get out of the case" with the decision to offer further treatment left for another time. Patient A.G. had been referred to Respondent for her persistent pelvic pain following an examination on April 27, 1999, that had been made by Margaret Cantor, a Nurse/Mid-Wife and Registered Nurse. She conducted a pelvic examination of the patient that date. The examination included the use of speculum to examine the cervix and vagina in the interest of looking for abnormalities, lesions, growths, and discolorations. No cervical lesions were found in this examination. A pap smear taken at the time revealed normal results with some inflammation. Diagnostic laparoscopy is a surgical procedure involving an incision in the abdominal wall through which a scope is inserted to visualize the abdominal cavity. Typically the workup for performing a diagnostic laparoscopy would include use of ultrasound, pelvic examination, and a pap smear. Possible complications in this procedure include vascular injury, bowel injury, bladder injury, infection, and bleeding. Preliminary to the diagnostic laparoscopy it is the custom and practice in the medical community to perform a vaginal examination with the use of a speculum. On July 1, 1999, patient A.G. was seen by the Respondent in his office for her pre-operative check. On this occasion A.G. was unaccompanied by a translator. Nonetheless, Respondent was able to perform a brief physical and obtain a history with the assistance of A.G.'s husband. Respondent listened to the patient's heart and lungs and performed a bi- manual examination in which one or two fingers were inserted in the vagina and with a hand on the abdomen compression was performed on the pelvic viscera, uterus, tubes, and ovaries and the lower section of the pelvis. Nothing significant was observed in the patient since last seen. On July 1, 1999, an employee in Respondent's office witnessed patient A.G. sign a consent form allowing the diagnostic laparoscopy. The consent form makes no reference to the agreement for Respondent to perform a loop electrocautery excision procedure, referred to by abbreviations as a "LEEP" conization biopsy procedure or a LEEP cone. No evidence of such consent is contained in patient A.G.'s medical records maintained at Respondent's office. The diagnostic laparoscopy was to be performed at TMH. On July 1, 1999, Patricia Charbonneau, a clinical nurse at the hospital, reviewed a consent form with patient A.G. concerning the diagnostic laparoscopy for the purposes of that facility. Nurse Charbonneau was aware of the scheduling of the diagnostic laparoscopy by reference to the history and physical prepared by the Respondent. This conference involved the discussion of potential risks and complications of the laparoscopy. No discussion was conducted concerning possible risks and complications of a LEEP conization biopsy. The consent form from TMH pertaining to patient A.G. and the diagnostic laparoscopy stated "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure, I request and authorize my physician to proceed." Nurse Charbonneau was left with the impression that the patient understood the explanation concerning the upcoming procedure and gave her consent. Ms. Charbonneau was assisted in this communication by A.G.'s husband. No discussion was held concerning the performance of a LEEP cone biopsy, in that the permit from Respondent made no mention of that procedure. Ms. Charbonneau took steps for an interpreter to be available the next morning when the surgery was to be performed given the nature of the surgery, the use of anesthesia and the desire to have "everything" reviewed again. A LEEP conization is a form of biopsy performed either in an office or hospital setting with anesthesia. The cervix is examined with the assistance of a speculum. Lugol solution is placed on the cervix to identify any abnormal cells and an excesion is made by shaving a small piece of the cervix for examination. The workup for LEEP conization includes a pap smear and a colposcopy. The performance of LEEP conization presents potential risks and complications related to infection, endometrious, bleeding, cervical stenosis, and cervical incompetence. On July 2, 1999, patient A.G. came to the TMH outpatient surgery center for her scheduled diagnostic laparoscopy to be performed by Respondent. She was the fourth patient on a schedule of surgeries to be performed by Respondent on that date. Respondent was conversant with the sequence of surgeries to be performed. Patient A.G. was placed in a holding area in the outpatient surgery center to prepare her for her surgery and to await transport to the operating room. Sometime before moving the patient to the operating room Respondent saw the patient in the holding area. Respondent addressed patient A.G. by saying hello and asking her how she was doing. This was not a visit intended to educate the patient and was not involved with any other medical purpose. At the time the patient's husband was with her during this brief encounter which was intended to confirm that the patient was there for the surgery as had been previously arranged. Several hours may have passed between the time Respondent saw patient A.G. in the holding area and when he next encountered the patient in the operating room. Respondent also saw patient N.C. in an adjacent cubicle to where patient A.G. was located while the patients were awaiting their surgery. Patient N.C. was the third patient on the schedule, there for the performance of a LEEP conization biopsy. Respondent followed his surgical schedule for the first two patients in the intended sequence. Some delay was occasioned by a problem experienced in the surgery performed on the second patient. Valerie Anne Lazzell, M.D., is an anesthesiologist licensed to practice in Florida. She is employed by Anesthesiology Associates of Tallahassee, Florida. It was intended that she provide anesthesia during Respondent's performance of the diagnostic laparoscopy for patient A.G. It was anticipated that the patient be subjected to general anesthesia which involves a rapid loss of consciousness and blocks the sensory, mental and motor functions of the patient. A general anesthesia can be provided by using an endotracheal tube, with a mask or with an LMA. This is as distinguished from the use of a neurolept employed in most instances when performing LEEP conization biopsies. In that setting the patient is generally anesic, not really aware, and has analgesia "on board." The use of a neurolept promotes a pain-free state of immobility and an insensitivity to pain and is usually accomplished by use of IV medications. From the record, it appears that Jean Mauch, C.R.N.A., with Anesthesiology Associates was scheduled to provide anesthesia by neurolept for the third patient N.C. who was scheduled for LEEP conization biopsy. Patient A.G. at the time in question was 4'9" tall and weighed 103 pounds. Patient N.C., an African-American woman was 5'2" tall and weighed 242 pounds. Their skin tone was similar in color. Dr. Lazzell saw patient A.G. before the patient was taken for surgery. In this examination the doctor filled out the patient's airway, listened to her heart and lungs, and considered the patient's ASA classification which was one of good health. Dr. Lazzell considered the plan for anesthesia with an endotracheal tube. She gained the assistance of a Dr. Becker who was fluent in Spanish in explaining the use of anesthesia to the patient. Dr. Lazzell sought Dr. Becker's assistance when the hospital did not make an interpreter available. Dr. Lazzell discussed the possible risks and complications of use of this form of anesthesia and a consent form was signed and dated. While this assessment was being made A.G.'s husband was in attendance. It was Dr. Lazzell's expectation that the patient A.G. would next be seen as scheduled when the nurse anesthetist called Dr. Lazzell to the operating room to intubate patient A.G. in association with the provision of anesthesia for the diagnostic laparoscopy. Jean Mauch, C.R.N.A., when performing her duties in the operating room setting at TMH outpatient surgery center was expected to induce anesthesia, maintain the anesthesia, monitor vital signs, treat untoward events during surgery and maintain fluids in the patient while under the supervision of the physician, in this instance, Dr. Lazzell. Nurse Mauch was principally responsible for providing the anesthesia for the third procedure on patient N.C., the LEEP conization biopsy. This included preparation in the operating room of medications and other related tools and supplies. The third procedure, the LEEP conization biopsy for N.C., was referred to on a typed surgical schedule in the preoperative desk in the outpatient surgery center. Having checked the schedule Nurse Mauch obtained the chart for N.C. and went to the cubical, not of N.C. but A.G. When Nurse Mauch arrived at A.G.'s cubical, Jamie Martin, R.N., the pre-op nurse and Dale Dunsmore, R.N., the circulating nurse, were there. Nurse Dunsmore and Nurse Mauch arrived at the cubicle where patient A.G. was located at about the same time. When arriving at the cubicle for patient A.G., Nurse Mauch had in mind that the process was one in which she was getting ready for the surgery to be performed on patient N.C. While in the cubical Nurse Mauch introduced herself to the person she believed to be the patient N.C., at which time Nurse Dunsmore said that the patient only speaks Spanish. Nurse Mauch recalls that a translator was not available for assisting in any communication with patient A.G. Realizing that Nurse Dunsmore was checking the armband for identification, the reference to the fact that the patient only spoke Spanish did not cause Nurse Mauch any concern. Nurse Mauch never heard Nurse Dunsmore orally refer to patient A.G. by name. Nurse Mauch continued with her presentation by commenting that she was the nurse anesthetist who was going to put the patient to sleep. Patient A.G. nodded her head in response to Nurse Mauch's physical gesture that the patient was going to be put to sleep. Beyond that point Nurse Mauch and Nurse Dunsmore took patient A.G. to the operating room ostensibly as the third patient on the schedule for provision of a LEEP conization biopsy wherein Nurse Mauch would provide the necessary anesthesia. The chart for N.C. was brought to the operating room. Before the patient was removed from the cubicle Nurse Martin provided pre-op medication to patient A.G., phenergan robinul. The fact that Nurse Martin was giving preoperative medication and that Nurse Dunsmore was checking the armband on what turned out to be patient A.G. led Nurse Mauch to believe that patient A.G. was patient N.C. the third scheduled patient, according to Nurse Mauch. As Nurse Mauch recalls, when the Respondent entered the operating room where the third scheduled procedure was to be performed he checked the chart for patient N.C. Respondent went out and washed his hands, returned and started the procedure. At the end of the procedure Nurse Mauch recalls Respondent commenting that the next patient speaks only Spanish, to which Nurse Mauch said, "No, this patient," meaning the patient who had been subjected to the procedure is the one who speaks Spanish. Respondent replied "I must be mixed up." Nurse Mauch recalls Dr. Lazzell arriving at the door of the operating room with patient A.G.'s chart. Dr. Lazzell looked surprised to find the circumstances. Nurse Mauch told Dr. Lazzell that this is the neurolept, the case involving the LEEP conization biopsy. Dr. Lazzell commented that "No it isn't." Nurse Mauch heard Dr. Lazzell ask Respondent, "What procedure did you do?" Respondent replied "LEEP conization." Dr. Lazzell said "No, this was supposed to be the diagnostic laparoscopy." Nurse Mauch observed Respondent leave the room and return. Patient A.G. was re-preped and the diagnostic laparoscopy scheduled to be provided was performed with the patient being intubated by the use of an endotracheal tube. Nurse Martin in her capacity as pre-op nurse was responsible for receiving patients and getting the patients ready for administering medications that were prescribed and getting IVs and things started on the patients prior to the patients being sent to the operating room. She recalls performing pre- operative duties on the patient A.G. Nurse Martin was familiar with the schedule of patients, the sequence. She understood that patient A.G. was the fourth patient in the schedule and provided the pre-anesthetic to patient A.G. in preparation for the operation. This involved the use of phenergan. Nurse Martin made no mistake in identifying patient A.G. when providing care. Nurse Martin heard Nurse Dunsmore identify patient A.G. in Nurse Martin's presence and agreed with that identification. Nurse Martin had seen the patient A.G. before the occasion at which Nurse Mauch and Nurse Dunsmore were there with the patient in Nurse Martin's presence and the patient A.G. was taken to the operating room. Nurse Martin had reviewed patient A.G.'s chart earlier in caring forward responsibilities for preparing the patient for the operation. Nurse Dunsmore identified her duties as circulating nurse at TMH outpatient surgery center as being related to setting up rooms for surgeries, transporting patients from pre-op holding areas, identifying patients, verifying surgeries, verifying allergies, and so forth. Ordinarily Nurse Dunsmore in performing her duties would read the chart of the patient scheduled for a procedure to make certain that all permits were signed. She would then go to where the patient was being held, introduce herself to the patient and ask for identification, verifying the surgery that is scheduled for the patient, and perform other related assignments. In performing her duties Nurse Dunsmore would accompany the patient with the anesthesiologist to the operating room. The method of identification in effect at the time in question would be to compare an addressograph card which accompanied the patient's chart with the information on an identification bracelet worn by the patient. Nurse Dunsmore verified that the operating room for the third procedure was set up for a LEEP conization biopsy. After the second procedure on the schedule, Nurse Dunsmore recalls that she went to patient A.G.'s room. However Nurse Dunsmore had handed Nurse Mauch patient N.C.'s chart. Nurse Mauch carried the chart to patient A.G.'s cubicle. The two nurses essentially entered the cubicle together. Nurse Martin and patient A.G.'s husband were already there. Nurse Martin left the cubicle shortly thereafter. Nurse Dunsmore introduced herself to the patient and reached for the patient's identification bracelet and read it out loud. The patient smiled and nodded in response. In turn the patient's husband smiled and nodded in response. Patient A.G. was then taken to the operating room by Nurse Dunsmore and Nurse Mauch. The patient was sedated by Nurse Mauch and positioned for provision of the LEEP conization biopsy. Nurse Dunsmore observed the Respondent enter the operating room and look at the chart which was in relation to patient N.C., not patient A.G. Nurse Dunsmore saw Respondent leave the operating room to scrub. Nurse Dunsmore was in attendance when the procedure was performed. Nurse Dunsmore recalls Dr. Lazzell entering the operating room at the end of the procedure with the chart belonging to patient A.G. and the realization by those in attendance that the chart in the operating room was for N.C., whom they understood to be undergoing the procedure when in fact the patient undergoing the procedure was A.G. Diane Jordan was a surgical technician assigned to assist in the third procedure, the LEEP conization biopsy. She recalls the patient being put to sleep by Nurse Mauch and the patient being prepared for the procedure. The patient was covered by draping towels across the upper portion of the thighs. A blanket was placed over the patient's torso. The patient was placed in the lithotomy position allowing observation of the patient's buttocks, vulva, vagina and external pelvic organs. The patient had a mask on her face and a surgical hat to cover her hair. All of these arrangements had been made before Respondent entered the operating room. Ms. Jordan recalls that the chart in the room was for N.C., the patient anticipated to undergo the LEEP conization biopsy. Ms. Jordan did not realize that the patient in reality was patient A.G. Ms. Jordan recalls that the Respondent when entering the room asked is this "such and such" in relation to a LEEP conization biopsy and that Nurse Dunsmore replied in the affirmative. Ms. Jordan remembers Respondent looking at the chart for N.C. and signing it. Ms. Jordan was in attendance while the procedure was performed. Ms. Jordan heard Respondent mention something about a lesion before he started. Ms. Jordan provided medication to be injected during the LEEP conization. Ms. Jordan identified the fact that a specimen was obtained which was given to her and provided to the nurse to send to pathology for evaluation. When Respondent entered the room for what he anticipated to be the third procedure what he asked specifically was "Is this Ms. C our case for the LEEP?" referring to the LEEP conization to be performed on patient N.C. That is when Nurse Dunsmore responded in the affirmative. After inquiring about the identification of the patient in association with the nature of the procedure Respondent expected to perform and in receiving an affirmative response, Respondent took no further steps to personally confirm the identity of the patient. Respondent opened the chart that was patient N.C.'s chart. Respondent took a drawing from his pocket that a Dr. Thompson had made of patient N.C.'s cervix when he had treated the patient. The drawing was in association with a colposcopy. Respondent intended to compare that drawing with what was observed in the patient during the performance of the LEEP conization biopsy in locating the suspected pathology. In proceeding with what he considered to be the third scheduled procedure for N.C., Respondent placed the speculum, applied the tenaculum and observed what looked to be a lesion that roughly approximated what he anticipated it would be based upon the drawing from Dr. Thompson. Respondent applied Lugol's solution and proceeded with the LEEP conization biopsy. Having applied the solution there was an indication of some pathology in roughly the position as the drawing had depicted. Respondent obtained the sample from the cervix. The size of the specimen was less than the diameter of a dime with a depth or thickness of about two dimes. The performance of the LEEP conization biopsy took less than five minutes. As Respondent finished Dr. Lazzell came to the operating room and informed Respondent that this was not the patient the he thought he was treating. Having been told by Dr. Lazzell that there was a misidentification, Respondent for the first time while engaged with the patient in the operating room proceeded to the front of the table and looked at the patient while the patient was being unmasked. By doing so Respondent discovered that indeed the patient had been misidentified and that he had actually performed surgery on patient A.G., not patient N.C. Respondent left the operating room and informed patient A.G.'s husband of the problem. Respondent returned to the operating room. The patient was provided anesthesia by Dr. Lazzell and the diagnostic laparoscopy that was scheduled was performed. Notwithstanding that it was never intended that Respondent perform a biopsy on patient A.G. from the cervix, Respondent expresses the opinion that if the physician encounters a visible lesion some form of biopsy is in order. Respondent expresses the opinion that in performing procedures such as a diagnostic laparoscopy greater latitude is afforded in terms of what the physician can do when he or she discovers "What's amiss with the patient." This in Respondent's view is because the patient is going into the procedure with the understanding that there may be an unanticipated problem and if the unexpected problem can be addressed, it should be taken care of. Of course this assumes that the biopsy that was performed on patient A.G. was in association with the scheduled diagnostic laparoscopy, when in fact the biopsy was the product of happenstance, in that, Respondent when addressing what he considered to be the condition in the patient N.C., by chance observed a similar condition in the patient A.G. Respondent concedes that prior to patient A.G.'s arrival at the outpatient surgical center that LEEP conization was not an indicated procedure for that patient. The biopsy that was performed was with the misapprehension as to the patient whose needs were being addressed, not merely an unanticipated circumstance in a patient whose identity was established when Respondent performed the biopsy. This was not an additional surgical procedure that came about in connection with the scheduled diagnostic laparoscopy; it was perceived by Respondent as the intended surgery being performed on a different patient when the case began. As a consequence it is the planned- for diagnostic laparoscopy which became the additional procedure. Nonetheless, Respondent tries to explain his result by expressing the opinion that other unexpected and unplanned-for procedures may be undertaken in the instance "Within the realm of the comfort level of the physician and the patient ahead of time; where they know each other, other things can be done as well." Respondent believes that the ability to proceed with the biopsy on patient A.G. while thinking that he was responding to the case involving patient N.C. is implicit and is promoted by "A feeling of trust that we had developed at the point in time." This refers to the point in time at which the other surgery, the diagnostic laparoscopy was being discussed with the patient A.G. The type of pathology that was encountered by Respondent with patient A.G. that led to the biopsy was compatible with condyloma with warty atypia. That is what Respondent observed and collected for evaluation. The laboratory confirmation of the specimen was performed by Dr. Woodard Burgert, a board-certified anatomic and clinical pathologist. In his assessment Dr. Burgert observed that the cone biopsy in question was compatible with condyloma with warty atypia. There was no significant dysplasia. Expert Opinions Dr. Edward Zelnick is a board-certified obstetrician and gynecologist who practices in Florida. He has hospital privileges at Hollywood Medical Center and Memorial Regional Hospital. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. In the instance where pathology is found in examining the cervix, Dr. Zelnick believes that action should be taken in addressing that pathology, but only in the instance where the pathology has been discussed with the patient and the appropriate alternative treatment has been discussed. Absent an emergency it is necessary to provide the patient the alternative to surgery and identify the risk of surgery. Absent life-threatening circumstances, a biopsy such as that performed on patient A.G. should not be performed without the patient's consent, which had not been given. Dr. Zelnick further describes the instance in which a biopsy in a case such as this would be in order, would be in relation to an instance in which it appeared that the circumstance was an immediate threat to the health of the patient that needed to be addressed. None of the exigent circumstances existed in this case. Therefore, Dr. Zelnick expresses the opinion that the performance of the biopsy by Respondent did not meet the expected standard of care. Based upon his familiarity with the form of consent in this case which states, "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure I request and authorize my physician to proceed," Dr. Zelnick believes that the physician's responsibility there is to respond during the course of the surgery, if medically necessary, to such matters as repairing of a blood vessel that has been cut or damage to an internal organ or bowel. None of those circumstances were associated with the biopsy performed on the patient A.G.. While Dr. Zelnick delegates patient identification to surgical staff or nursing staff, he believes that the ultimate responsibility for patient identification to make certain that the right operation is performed on the proper patient resides with the surgeon. To do less is to practice below the standard of care universally accepted and a matter of common sense. According to Dr. Zelnick, Respondent did not meet that standard when performing the biopsy on patient A.G. who was misidentified. Whatever rules and procedures may be in place setting standards for identification in a hospital, Dr. Zelnick does not believe those standards abrogate the duty of the physician to properly identify the patient. What is expected of a physician is 100 percent certainty as to who the proper patient is and to assure that the proper procedure is carried out on the proper patient. The method of arriving at that determination is not significant, in Dr. Zelnick's view. Dr. Roberto Fojo is a board-certified obstetrician and gynecologist licensed to practice medicine in Florida. He has hospital privileges at Jackson Memorial and North Shore Medical Center in South Florida, and he is affiliated with the University of Miami, Department of Obstetrics and Gynecology, Division of Gynecology. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He does not view a diagnostic laparoscopy as being intended to discover and diagnose cervical lesions, where, as here, the lesion is on the surface of the cervix and vagina. A diagnostic laparoscopy is not intended to promote an examination of the cervix, according to Dr. Fojo. Dr. Fojo is familiar with the consent form executed by patient A.G., the language previously described. He has seen that language before or something similar to it and considers it part of the standard surgical consent in connection with a diagnostic laparoscopy that was intended in this case. The consent is designed to allow the surgeon to address matters such as puncture of the bowel or a problem with a major artery or veins or scar tissue or adhesions. This consent would not include addressing lesions on the cervix. A LEEP conization procedure is not an accepted procedure to perform in the patient undergoing diagnostic laparoscopy unless the LEEP conization had already been discussed and there was a problem with the cervix that the patient knew about. There, in Dr. Fojo's perception, the patient would be undergoing what he refers to as dual procedure. Dr. Fojo does not believe that surgery should be performed on a patient absent the patient's consent as being part of the original procedure or in an emergency. The LEEP conization biopsy by Respondent was not related to the consent that had been provided nor pertaining to an emergency. In this sense, Dr. Fojo expresses the opinion that Respondent failed to meet the standard for medical practice when performing the LEEP conization biopsy on Patient A.G. Dr. Fojo believes that a surgeon should ascertain without any doubt that the patient in the room is a patient that he or she should be performing surgery on, the appropriate surgical procedure. This need for identification is an independent responsibility of the physician and may not be delegated. It requires 100 percent accuracy, according to Dr. Fojo. Dr. Fojo holds to the opinion that the physician is responsible for the identification regardless of his or her efforts that may have been compromised by others in attempting to properly identify the patient and perform the indicated procedure. He believes this to be common medical practice. Respondent was not within the standard of care in performing the LEEP conization procedure on patient A.G. under Dr. Fojo's assessment. Dr. Michelle McCallanahan is a board-certified obstetrician and gynecologist who is licensed in Florida and practices in Jacksonville, Florida. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. The consent form executed by patient A.G. is not unfamiliar to Dr. McCallanahan. Her perception of this consent language is that it relates to complications that occur during the course of the diagnostic laparoscopy that were not foreseen and constitute an emergency requiring an immediate procedure to correct the condition. Examples are vascular injuries to vessels, bowel injury, bladder injury, infection and bleeding. By contrast, lesions on the cervix do not constitute an example of an unforeseen circumstance. Dr. McCallanahan expresses the opinion that an appropriate workup for LEEP conization was not done for the patient A.G. Nonetheless, there are some circumstances in which it would not be violative of the standard of care to perform LEEP conization without conducting a workup. That circumstance would be in the instance where the lesion that was observed was highly suggestive of cervical cancer, according to Dr. McCallanahan. The case that Respondent was presented with did not constitute such a condition. Ordinarily, the standard of care contemplates the discussion of possible risks or complications associated with LEEP conization procedures before performing them. According to Dr. McCallanahan it would be appropriate to perform a surgical procedure without discussion of the risks and possible complications in an emergency when the patient was unconscious and could not give consent in advance. Those are not the facts here. While Dr. McCallanahan relies upon the assistance of other persons within the surgical and nursing staff, she expresses the opinion that the ultimate responsibility for patient identification prior to the performance of surgery resides with the physician. She believes that it is below the standard of care to not correctly identify the patient before the procedure is done and perform an improper procedure or non- consenting procedure on that patient, as was the case here. Dr. Jana Bures-Forstheoefel is a board-certified obstetrician and gynecologist who is licensed in Florida. She practices in Tallahassee, Florida, and has privileges at TMH and performs surgeries in the outpatient surgery center. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. She believes that Respondent met the standard of care for identifying patient A.G. before performing surgery on the patient. The method used by Respondent to identify the patient was common to the practice of other physicians who performed surgeries in that setting, according to Dr. Forstheoefel. In the event that Dr. Forstheoefel was performing a diagnostic laparoscopy and observed a cervical lesion she would evaluate the condition to include the performance of a biopsy, the most common method for cervical biopsy being a LEEP conization. Notwithstanding the lack of specific consent by the patient for Respondent to perform the LEEP conization, Dr. Forstheoefel holds to the opinion that it was correct to biopsy, given what was observed in the patient. The prospect that a physician would be 100 percent accurate in identifying a patient undergoing surgery is not humanly possible and is a standard that should not be imposed upon a physician in Dr. Forstheoefel's opinion. She considers that the matter of proper identification preoperatively is a team effort. One person should not be solely responsible for all things in making certain of the patient's safety and assuring that the right thing is done. Dr. Kenneth John McAlpine is a board-certified obstetrician and gynecologist. He is licensed in Florida. At times relevant he performed surgeries at the TMH outpatient surgery center. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He believes that Respondent met the standard of care in identifying the patient A.G. before performing the surgery and in performing the LEEP conization on that patient. Although Dr. McAlpine has not experienced a situation in which he observed a reason to do a LEEP conization in a diagnostic laparoscopy case, where consent for LEEP conization had not been given ahead of time, he does not question the decision to address the condition observed, such as in the case at issue. From his point of view, it was acceptable to do a LEEP conization biopsy to address the lesion. Although no prior indication existed before the lesion was observed during the procedure Dr. McAlpine would not want to ignore the lesion. Dr. McAlpine believes that the process that Respondent undertook in identifying the patient A.G. before surgery was consistent with practices in effect at the hospital, this included reliance on staff in the operating room. Dr. McAlpine does not believe that it is necessary for a physician to be 100 percent accurate in the identification as a person ultimately in charge. No matter as to the facts, he sees the issue of the identification being a multi-disciplinary approach among health care providers. Dr. David O'Bryan practices obstetrics and gynecology. He is licensed in Florida. At times relevant he performed surgeries at TMH outpatient surgery center. He is familiar with the type procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. The method employed by Respondent in identifying the patient was consistent with the practice used in the immediate medical community at the time, according to Dr. O'Bryan. Dr. O'Bryan believes that the Respondent performed the appropriate surgery on Patient A.G. For Dr. O'Bryan, what is more important in addressing the patient's needs is the apparent pathology, not the consent that may have been provided by the patient in advance of the procedure. It would be negligent not to address the lesion on the cervix in his view. The pathology present determines the response even without a consent for the procedure. Dr. O'Bryan did not consider that the pathology constituted an issue of life or death. The fact that the LEEP conization biopsy was not planned was less significant than the need to address the pathology. It does not matter if the patient were A.G. or N.C. or some other patient, Dr. O'Bryan believes that it was appropriate to perform the biopsy. Dr. O'Bryan believes that the surgeon bears a great deal of responsibility in patient identification, but the ultimate responsibility for identification does not reside with the physician or any other operating room staff member in Dr. O'Bryan's assessment. Dr. O'Bryan does not conceive that there can be any greater comfort in the identification than in the instance where the "operating room crew" tells the physician who it is and the physician has a chart in his hands which indicates that it is the same patient as the operating staff has identified and the pathology that was found is consistent with what had been anticipated according to the patient chart and the staff identification. Nothing in medicine involves the imposition of a 100 percent standard of care to include properly identifying the patient preoperatively, according to Dr. O'Bryan. Dr. Roberto Morales is a board-certified obstetrician in gynecology licensed to practice in Florida. At times relevant, he performed surgery at the TMH outpatient surgery center. He is familiar with the type procedures involved in Patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. Dr. Morales believes that Respondent met the standard of care for identifying the patient A.G. in that hospital and in other places as well. Dr. Morales believes that the patient was correctly identified by Respondent earlier in the day and that the incorrect patient was brought back to the operating room. Under those circumstances, Respondent did what was appropriate to identify the patient in the performance of the LEEP conization on patient A.G. and was within the standard of care, according to Dr. Morales. Assuming the patient was scheduled for a diagnostic laparoscopy, if during the examination, visualization of the cervix, a lesion was observed, a biopsy would be the typical next step, according to Dr. Morales. The caveat to his opinion in the ability to perform that biopsy would depend upon the patient that was being taken care of and the sense that the physician had about the patient's expectations of what should be done and not done. It is assumed that Dr. Morales believed that the level of relationship between Respondent and Patient A.G. would allow the performance of the LEEP conization biopsy. Dr. Morales believes that the attempt to be 100 percent accurate in the identification of patients preoperatively is an aspirational goal, not a requirement. For him all persons concerned have the responsibility for taking care of the patient. Having considered the opinions expressed by the experts, the ultimate facts to be determined must be based upon the realization that Respondent proceeded to perform the LEEP conization biopsy on patient A.G. without advance written consent, that Respondent believed that he was confronting the case of patient N.C., and that the performance of the LEEP conization on Patient A.G. was not in its timing and justification part of the diagnostic laparoscopy scheduled to be performed on Patient A.G. The earlier effort by Respondent to identify his patient in the holding area was sufficient for that stage of the process. Respondent acted in the customary manner in relying upon his knowledge that Patient N.C. was to be the third patient based upon the schedule. It was not unexpected that Respondent would rely upon the surgical staff in orally confirming the patient identity and the procedure to be performed when entering the operating room for the scheduled third procedure. This identification was further confirmed by the presence of the chart for Patient N.C. Respondent's failure to take further steps to physically identify the patient by looking at her arm bracelet, by looking at her face, or in some other manner recognizing the mistake that had been made by others in readying Patient A.G., and not Patient N.C. for surgery could be forgiven if there were no consequences, but there were. Although Respondent should not be the absolute guarantor in the identification of the patient, what he did in the operating room was not enough, when the result is that Respondent performed the LEEP conization that was not consented to in advance, and performed believing that the patient was N.C., the patient for whom the procedure was intended, and was not in response to an emergency regardless of patient identity. As a result, Respondent failed to meet the standard of care for reasonably prudent similar physicians under acceptable similar conditions and circumstances in his actions. In mitigation, the outcome was not harmful to the patient. Moreover, other health care professionals were in great measure responsible for the failure to properly identify the patient.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes, and imposing a $1,000.00 administrative fine and costs of investigation and prosecution. DONE AND ENTERED this 8th day of November, 2002, in Tallahassee, Leon County, Florida. CHARLES C. ADAMS 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 8th day of November, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Kim Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 David W. Moye, Esquire Linda Loomis Shelley, Esquire Fowler, White, Boggs and Banker, P.A. Post Office Box 11240 Tallahassee, Florida 32302 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon allegations that he violated Sections 456.072(1)(bb), and 458.331(1)(t), Florida Statutes (2003), in the care and treatment of Patient H.J.?
Findings Of Fact Stipulated Facts Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME: 65565. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes. On or about July 21, 2003, the Respondent performed peritoneal dialysis catheter removal on Patient H.J. at Bay Medical Center (Bay Medical). Peritoneal dialysis is a technique that uses the patient's own body tissues inside of the abdominal cavity to act as a filter. On or about August 25, 2003, Patient H.J. presented with erythema (a redness of the skin resulting from inflammation) and induration (localized hardening of soft tissue of the body) in the area where the peritoneal dialysis catheter had been removed. On or about December 3, 2003, the Respondent performed exploratory surgery of Patient H.J.'s wound. Additional Facts Patient H.J. suffers from end-stage kidney failure, diabetes and heart disease. Dr. Ahmad Oussama Refai treated Patient H.J. for his kidney failure. Dr. Refai is a board- certified Nephrologist. Dr. Refai referred Patient H.J. for placement of a peritoneal dialysis catheter (catheter) to address the end-stage kidney failure. The catheter, as Dr. Refai describes it, was intended to remove the poisonous material in the blood of Patient H.J. By using the catheter clean fluid is introduced into the abdomen where it remains for a period of about four hours. The fluid introduced contains electrolytes put in the patient's blood stream. After the residence time for the fluid expires, the fluid is withdrawn through the catheter removing the harmful material. The patient, once instructed, is capable of performing the procedures described. The other option in performing this method of dialysis is to use a device that is employed at nighttime called a cycler, used while the patient is asleep and without the need for the patient to conduct the process. The patient's use of the catheter for dialysis is referred to as "home dialysis." Before Dr. Refai referred the patient to Respondent to place the catheter, the patient had been treated for his end- stage renal disease through a forearm AV graph to provide hemodialysis. That technique allows access to the patient's blood through a shunt, with the blood being run through a machine and cleansed and returned back to the patient. This procedure is done several times a week at out-patient centers, whereas the peritoneal dialysis is done daily by the patient or at night. On June 30, 2000, Respondent saw Patient H.J. and determined that the patient was a good candidate for the surgery necessary to place the catheter to perform peritoneal dialysis. On July 19, 2000, Respondent placed the catheter and peritoneal dialysis treatment was commenced. Following the placement the catheter was used by the patient as overseen by the Dr. Refai. As Dr. Refai describes it, the catheter is a silestic tube that has two cuffs. The cuff at the lower level sits on the fascia where it is secured and the other cuff is just under the skin or in the subcutaneous tissue. Dr. Refai describes the cuffs as fuzzy. The cuffs are expected to induce an inflammatory process promoting scarring so that the body forms tissue to hold the catheter in place. Dr. Refai calls this a bond. Dr. Refai explains that the other parts of the catheter are "slippery." It is the fuzzy part that holds the catheter in place. Petitioner's Exhibit No. 5 is an unused catheter similar in design to that placed in Patient H.J. On July 7, 2003, Respondent, Dr. Refai, and a Dr. Dean discussed Patient H.J. and the plan to remove the catheter that was no longer adequately performing the dialysis. On July 21, 2003, Respondent did surgery to remove the catheter from Patient H.J. On July 17, 2003, before Respondent did the surgery to remove the catheter, an explanation was made to Patient H.J. of the risks associated with the surgery as to bleeding, infection, MI stroke, death, and allergic reaction following removal of the catheter. Following the surgery Dr. Refai as the treating physician was aware that the wound associated with the surgery was not healing well and Dr. Refai sent Patient H.J. back to Respondent. Dr. Refai is familiar with the course of antibiotics prescribed for Patient H.J. to respond to the condition and the surgical exploration done by Respondent where a piece of cuff, as Dr. Refai describes it, was removed and the wound healed. December 3, 2003, was the date of the exploratory surgery. At that time, Patient H.J. was on hemo-dialysis and was being seen by Dr. Refai once a week. In Dr. Refai's opinion Patient H.J. was doing remarkably well, making allowances for his underlying condition (illnesses). At present Dr. Refai is aware that the patient is on the list to receive a kidney transplant. On August 1, 2003, Respondent saw Patient H.J. In his notes Respondent stated: His wounds look good. There is no evidence of infection. No fever or chills. He looks well. He is not taking any pain medicine. I am going to see him back in a month for a final visit. On August 25, 2003, Respondent saw Patient H.J. again. The Respondent's notes stated: His p.d. catheter removal site which was removed 4 weeks ago has some erythema and induration around it. I ultrasounded it here in the office and it looked like there was a little fluid. I anesthetized the area and opened it. There was no gross pus. I am going ahead and treat [sic] him with some Keflex and have him see Dr. Beaver on Friday as I am going to be out of town. This may come to a head and become an abscess. It may just be some cellulitis. I am not real sure why he would have cellulites as it certainly did not look like a hernia. I am going to have him see Dr. Beaver on Friday and make sure it is improving. On August 29, 2003, a note was made by Dr. Beaver concerning his visit with Patient H.J. In that note Dr. Beaver said: Patient of Dr. Kinsey. He was seen back for re-check. Apparently he was having some questionable cellulites around his p.d. cath today. He states that he is feeling much better. On examination, I see no redness at all and per the office assistance it has much improved. There is really not tender [sic]. It looks to me like it is improving. We will plan for him to see Dr. Kinsey back next week. On September 12, 2003, Respondent saw Patient H.J. and in the office note stated: The area in his left lower quadrant is completely healed. He is doing well. I am going to see him back in one month for a final visit. On September 16, 2003, Respondent saw Patient H.J. again and in the office note stated: He had some drainage from his previous p.d. catheter site. It does not appear to be infected. I am going to follow this area and see him in the office in a month. On September 30, 2003, Respondent saw Patient H.J. again and in the office note it states: He still has some drainage from the p.d. catheter exit site [sic] it was done about eight weeks ago. I told him that I would like to leave that along [sic] for at least three months and follow that. If it does not improve after three to four months then we may need to explore the wound but it may be a piece of suture that it [sic] trying to spit. We will see him back in the office in about 6 to 8 weeks. On November 11, 2003, Respondent saw Patient H.J. and noted: He is still draining from his p.d. catheter exit site. This has been 5 months. It is time to explore the wound. We will proceed to the operating room for exploration in the sinus tract. I suspect that there will be a piece of the catheter in the bottom of the wound. On December 1, 2003 Respondent saw Patient H.J. for the pre-operative visit. At that time he noted: He is here for a pre-op for a wound exploration for his p.d. catheter removal site. He still has some granulation tissue there. I am going to plan to probe the area and evaluate where the sinus goes. On December 3, 2003, the surgery was conducted on Patient H.J. and Respondent noted: He underwent a left lower quadrant wound exploration. The p.d. catheter cuff was within the subcutaneous tissue and that is why his wound [sic] not close. This was removed and then the would [sic] was closed. He tolerated the procedure well. The various surgeries that have been discussed which were performed by Respondent took place at Bay Medical in Panama City, Florida. In the operative procedure report at the hospital related to the December 3, 2003 exploratory operation Respondent described a pre-operative diagnosis as: Non-healing wound, left lower quadrant of the abdomen. The post-operative diagnosis stated: Non-healing wound, left lower quadrant of the abdomen. Foreign body (peritoneal dialysis catheter cuff), left lower quadrant abdominal wound. The procedure performed was described as: Wound exploration and foreign body removal. The intra-operative findings related to the operation were: He was found to have a cuff of the catheter within the tissue. He had a small piece of p.d. catheter attached to it. The cuff had obviously broken. The catheter was broken with a cuff remaining in the subcu tissue. There was no intra-abdominal portion. In comparison, on July 21, 2003, in the operative/procedure report at Bay Medical through the description of the procedure to remove the catheter Respondent stated: . . . The previous incision in the left hypogastric area was anesthetized with local anesthetic and sharply incised. This was carried into the subcutaneous tissue and p.d.-catheter dissected and divided. The catheter was then pulled from the subcutaneous tissue at the exit site. The catheter was then delivered into the wound and abdominal wall cuff sharply incised and the catheter removed. The fascial edges were then reapproximated with 2 figure-of-eight0- vicryl sutures. On July 21, 2003, when Respondent removed the catheter from Patient H.J. no pathology was ordered. On December 3, 2003, following the exploratory surgery and retrieval of the catheter pathology was ordered. Daniel G. Dena was the pathologist at Bay Medical who addressed the specimen which was described by the pathologist as: "Tissue-p.d. catheter cuff" The anatomic diagnosis referred stated: "p.d. catheter cuff: plastic catheter, with attached fibro-fatty tissue at one end, showing acute and chronic inflammation." The macroscopic examination in the pathology report stated: "The specimen is labeled 'pd catheter cuff'. Received is a portion of plastic tubing measuring approximately 5 cm in length and up to 0.5 cm in diameter, with a cuff of soft tissue at one end measuring 2.5 cm in length and 1.2 cm in diameter." On July 26, 2004, in responding to the investigation that led to this prosecution Respondent stated in writing in relation to Patient H.J.: The original peritoneal dialysis catheter removal had gone uneventfully and I felt that both cuffs of the catheter had been removed in their entirety. But this was found not to be the case. I have placed a number of these catheters and removed a number as well and have not had this type of problem before. Visual inspection of the catheter on removal is routinely undertaken to ensure that the cuffs are removed and I felt that this had been completely removed but I was obviously mistaken. I am not sure if this was a defect in the catheter. Evaluation of the catheter and assurance of complete cuff removal would have probably prevented this process. I am certainly more cognizant of this being a problem in subsequent catheters that I have removed. At the original time of catheter removal the operative site appeared appropriate. At hearing Respondent offered additional explanation concerning the July 21, 2003 operation to remove the catheter from Patient H.J. and the exploratory surgery on December 3, 2003. As Respondent explained, in the July 21, 2003 surgery Respondent made a 3-to-4 cm incision about the belly button towards the middle of the abdomen through the skin, subcutaneous tissue, the fascial layer and muscle and peritoneal layer. The peritoneal layer is a semi-permeable membrane that waste products removed in the dialysis will cross. The catheter is placed into the abdomen. The catheter is 12 to 14 inches in length with a curlicue tail and holes in the end of the catheter that allows the fluids to be introduced and withdrawn from the abdomen. As Respondent explained the catheter has two cuffs, the smaller of which is designed for placement in the rectus muscle located along the inset part of the abdomen. The smaller cuff sits inside that muscle. Tissue attaches to that cuff to keep fluid from leaking out, to keep the catheter in place and to prevent bacteria from going down the outside of the catheter. There is a segment of the catheter between that cuff and a larger cuff which sits underneath the skin in the subcutaneous tissue. The tissue in that area attaches to the cuff and serves to hold the catheter in place. When removing the catheter on July 21, 2003, Respondent used an incision of about 3 cm and encountered the mid-portion of the catheter located between the two cuffs which was dissected down through the fascia and taken out with the portion in the abdomen being removed first. Before making the incision to remove the catheter, Respondent cut the portion of the catheter outside the body of Patient H.J. off, including the metal and plastic valves and other paraphernalia hanging out of the patient. The purpose of removing the catheter outside the patient's body was in the interest of protecting the surgical field from contamination to avoid wound infection. The part removed inside the patient initially was the intra-abdominal portion. The intra-abdominal portion of the catheter, including the cuff in that area was sharply removed. The cuff was 2 or 3 times the size that it would have been when first placed and the part around the cuff was cut to allow the catheter to be extracted. The area of the fascia was closed. Next Respondent addressed the subcutaneous portion of the catheter by following it out and sharply cutting the tissue around the catheter and the subcutaneous cuff with scissors to remove that portion which also had an ingrowth of scar and fibroblastic tissue. Once the portions of the catheter with the cuffs, had been removed Respondent looked to determine if he had both cuffs which appeared at that time as a wad of scar and tissue. Respondent then closed the wound. Respondent believed that he had removed the whole catheter, to include the cuffs. In fact the subcutaneous cuff was not entirely removed and another portion of the catheter remained in the patient following the July 21, 2003 surgery. Respondent's estimate of what had been left in the patient and removed on December 3, 2003, was about 2 cm of the subcutaneous cuff and then a portion of the balance of the catheter. In commenting on the difference between the pathology report and his visual assessment on December 3, 2003, Respondent remarked about "all the stuff" grown onto the cuff and catheter. He also said it had a lot of specimen, taken to mean the "stuff" attached to the cuff and catheter. Although in the operative notes from December 3, 2003, Respondent says the catheter broke, at hearing he stated that he did not know whether the catheter had been cut or broke during the July 21, 2003 procedure to remove the catheter. No independent tests were conducted to determine whether the catheter broke during the July 21, 2003 surgery or was cut by Respondent. Respondent does not precisely remember the appearance of the catheter, to include the cuffs, when examining it on July 21, 2003. But he believed that he had successfully removed the entire catheter. In his testimony Respondent describes the office visits subsequent to the July 21, 2003 surgery. When he saw Patient H.J. he observed cellulitis around the area of the incision which was treated with oral antibiotics and resolved. Respondent used ultrasound to determine whether fluid had collected in the area where he observed the cellulitis. No fluid collection was seen. Drainage was noticed around the exit site where the catheter came out of the skin, which ordinarily takes a month to six weeks to heal. Concerning the drainage around this exit site, Respondent expected the drainage to resolve within around five weeks unless there were a piece of suture or other kind of event keeping the site opened and draining. The wound site where the incision was made healed without incident. The exit site continued to drain. After a time Respondent concluded that the reason for the drainage was either an epithelilized sinus tract, a piece of suture, a piece of catheter, a piece of cuff, or a piece of dressing for the wound. Respondent waited a time before doing the exploratory surgery in view of the use of an absorbable suture in the July 21, 2003 surgery which would have dissolved over time, precluding the need to do the exploration. Respondent, given the problem with the drainage from Patient H.J. following the July 21, 2003 surgery to remove the catheter, does not believe that the failure to remove this fragment would have killed the patient or have caused a lot of problems, but it was bothersome enough that it was worth the effort to try and find it and get the patient healed. Respondent in dictating his post-operative note on December 3, 2003, thinks that the catheter had broken and continues to hold to that belief, although he recognizes that it may have been cut in the prior surgery. Concerning his practice at Bay Medical, Respondent did not routinely have an X-ray done for patients undergoing surgery without a more specific reason for ordering it. Nor did he order a pathology examination following surgery absent the need for specific information. Patient H.J. in his testimony described the level of pain following the July 21, 2003 surgery to remove the catheter as "a little pain." Expert Opinion Dr. Stanley P. Kococki is a general surgeon licensed in Florida. He is board-certified in general surgery. He has had experience placing and removing peritoneal dialysis catheters. He was qualified to offer expert opinion testimony concerning Respondent's treatment of Patient H.J., in particular, the surgery performed July 21, 2003. Dr. Kococki expressed the opinion that the Respondent fell below the standard of care in treating Patient H.J., in that Respondent failed to recognize that he had left a portion of the catheter in the patient, which Dr. Kococki describes as a retained foreign body and that this caused the patient to undergo a second unnecessary procedure, meaning that the second procedure would not have been necessary if the catheter had been removed completely in the first surgery. The failure to remove could possibly have caused serious problems for the patient, to include septicemia and death, according to Dr. Kococki. Dr. Kococki refers to the Respondent's obligation in removing the catheter, to make certain that the whole catheter was removed and that the wound properly healed beyond that point so that the patient would not experience problems. While recognizing that there are different techniques for removing the catheter from Patient H.J., Dr. Kococki took issue with the method employed by the Respondent. Dr. Kococki believes that there are other methods for avoiding the problem with infection than to cut the catheter outside the body. There was no description of the use of a hemostat or clamps to hold the retained part of the catheter once the outside segment had been cut, so that the remaining portion of the catheter would not be lost under the skin. In addition, by cutting the catheter in two places there was a chance of leaving a piece of the catheter in the patient. Dr. Kococki expressed the opinion that when you cut the catheter in several places you have to remember where the pieces of the catheter are left in the patient. Given other circumstances during the surgery that occupy the surgeon's mind, it can lead to leaving a piece of catheter behind. Dr. Kococki expressed the opinion that leaving the catheter behind was not in the best interest of the patient because it led to subsequent surgery and had the sinus tract closed over the foreign body would have caused a localized infection and abscess formation around that area and possibly allowed for the bacteria from the abscess to enter the patient's bloodstream causing sepsis, and abscess formation in other organs, possibly the abdominal cavity, with a possible rupture intra-abdominally causing the patient to have generalized peritonitis. That can be life threatening and ultimately lethal. It is more of a problem with the person that has end-stage renal failure, in that the patient has a weakened immune system and lessened prospects to fight off infection. Dr. Kococki relied upon the pathology report made after the December 3, 2003 surgery to accurately describe the size of the segment that was left in the patient. In order to ascertain what actually happened with the catheter Dr. Kococki believes that the company or an independent examining body would have to determine if the catheter was defective. Even in the instance where the catheter may have broken in the initial surgery to remove it on July 21, 2003, the onus is still on the surgeon removing the catheter to examine it to make certain it was removed intact. Dr. Kococki characterizes the catheter as commonly present and utilized in surgical procedures to place and remove peritoneal dialysis catheters. Dr. Kococki describes the catheter as a medical device, unlike a sponge, forceps, clamp or surgical needle. Dr. Kococki recognizes that the purpose of the catheter is to perform dialysis but the retained portion left after the initial surgery to remove the catheter does not have a medical purpose, in his judgment. Dr. Kococki describes the cuff in the field related to the abdominal wall as providing a seal to avoid bacteria. The cuff as he understands it has an antibiotic coating that will help fight off infection. The cuff reacts with the patient's body tissue to act as a sealant. To have avoided the problem of failing to account for a portion of the catheter during the initial surgery to remove it from Patient H.J., Dr. Kococki believes that the easiest thing to have done was while the patient was in the operating room send the catheter to a pathologist and have it measured for comparison against the known size of the catheter when first placed. A second safe-guard would be to use a portable X-ray of the abdominal cavity to make sure that there was no radiopaque material in the abdomen or subcutaneous tissue. The catheter has radiopaque material allowing this identification in Dr. Kococki's understanding. Dr. Kococki was not familiar with the procedures at Bay Medical where the catheter removal from Patient H.J. was performed. The bylaws of the institution do not require that the catheter be sent to pathology following removal. Dr. Thomas A. Gadacz testified in the interest of Respondent. He is licensed in several states. He is not licensed in Florida. He is an expert in the field of general surgery. He has placed and removed peritoneal dialysis catheters. Dr. Gadacz describes the catheter as a medical device. It has nothing in common with a sponge, forceps, clamp or surgical needle, in his opinion. As a surgeon Dr. Gadacz refers to sponges, forceps, clamps and surgical needles as items whose sole purpose is to assist during an operation, not intended to be left in the body. They are to facilitate an operation to provide exposure, to conduct the operation but they are not a therapeutic modality. By contrast the peritoneal dialysis catheter is used primarily for therapy by remaining in the patient for specified periods of time to treat the patient. Other aids in performing an operation are cotton balls called kitners, metal retractors and cannulas. Dr. Gadacz explains that the purpose of the cuffs related to the catheter is to react to the body so that tissue grows around them. The other part of the catheter made of Teflon is designed to be non-reactive. Dr. Gadacz is aware that catheters of the type under discussion have fractured or broken. Dr. Gadacz explained that the fracture of a cuff is not common. In his experience, in the instance where a segment broke in a catheter, Dr. Gadacz removed it. On the other hand the failure to remove the piece is not necessarily below the standard of care as Dr. Gadacz explains, "because some times this happens, and its, you don't know that that has happened." The possibility of knowing that the segment broke off is difficult. As Dr. Gadacz describes, it was impossible given the tract involved with the surgery here. The gross inspection of the catheter once removed from the patient is a process in which it is difficult to make certain that both cuffs are there because of the encrusting fibrous tissue found after removing the cuffs, causing the cuffs to no longer have the same appearance as when first placed. The visual inspection made of the catheter after removal would not necessarily reveal whether it was removed in its entirety, according to Dr. Gadacz. Dr. Gadacz is unfamiliar with surgeons who would use an X-ray after removal of the catheter to confirm that the entire catheter had been removed. Instead he defers to Respondent's operative note on December 3, 2003, where the Respondent says that the catheter had obviously broken to explain the failure to retrieve the catheter. Dr. Gadacz does not believe sending the catheter to pathology after it was removed on July 21, 2003, would necessarily have been useful because it would take familiarity on the part of the pathologist with that form of catheter to recognize that a part was missing. Dr. Gadacz recognizes that the fragment from the catheter left in Patient H.J. at the end of the initial surgery to remove the catheter is medically considered a foreign body because it was not part of the human body. Dr. Gadacz found nothing in the care provided by Respondent by to Patient H.J. after the July 21, 2003 surgery that was questionable. Dr. Gadacz did not find the technique Respondent used in removing the catheter on July 21, 2003, from the Patient H.J. to be below the standard of care. Generally Dr. Gadacz did not express the opinion that Respondent practiced below the standard of care. Dr. Gadacz explained that had the segment continued to be present in the patient there would have been a major risk of continuing infection and ultimately the patient could have developed a serious abscess in the subcutaneous tissue that could become life-threatening or nothing may have happened, and the segment may have been walled off by the patient's body. In determining the comparability of what is described in Section 456.072(1)(bb), Florida Statutes (2003), as "other paraphernalia," to those items listed within that section, "such as a sponge, clamp, forceps, surgical needle," that are "used in surgical examination, or other diagnostic procedures," reliance is made upon testimony from Dr. Gadacz. As a surgeon, the opinion by Dr. Kococki is rejected for reasons that will be explained in the conclusions of law. When considering whether Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, as envisioned by Section 458.331(1)(t), Florida Statutes (2003), with the specificity called for in that provision, Dr. Kococki is more compelling in his opinion that the fragment left in Patient H.J. should have been removed in the earlier operation whether it broke or was cut by Respondent. The notion that there are times when some portion of the catheter may have been left in the patient, as was the case here, with no consequences to the practitioner, as expressed by Dr. Gadacz is not persuasive. Disciplinary History The Respondent has no prior disciplinary history.
Recommendation Based upon the findings of fact, and conclusions of law, and the guidance set forth in Florida Administrative Code Rule 64B8- 8.001, it is RECOMMENDED: That a final order be entered finding that Respondent did not violate Section 456.072(1)(bb), Florida Statutes (2003); that Respondent did violate Section 458.331(1)(t), Florida Statutes (2003); placing Respondent on probation for two years; imposing an administrative fine in the amount of $2,500.00; requiring Respondent to perform 50 hours of community service; requiring the completion of 5 hours of continuing medical education on "risk management" and requiring him to present a one-hour lecture to a group of peers discussing retention of foreign bodies in surgeries and techniques to avoid the retention. DONE AND ENTERED this 14th day of February, 2006, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 14th day of February, 2006. COPIES FURNISHED: William F. Miller Ephraim D. Livingston Assistants General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Albert Peacock, Esquire 8554 Congressional Drive Tallahassee, Florida 32312 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issue in this case is whether, under Section 57.111, Florida Statutes, Petitioner is entitled to attorneys' fees and costs incurred in the defense of a disciplinary proceeding.
Findings Of Fact On September 2, 1988, an 83-year-old female was admitted to West Orange Memorial Hospital with recurrent rectal bleeding and complaints of pain in the low back and left hip. The patient also reported pain while sitting or lying due to a subcutaneous nodule in the left buttock. As noted in the patient's history dictated by Petitioner on September 12, 1988, the patient had numerous admissions to the hospital for rectal bleeding and previously had been diagnosed as suffering from angiodysplasia. These notes also reflect that the patient had recently undergone a colonoscopy and upper endoscopy, which were negative. The notes of N. Alar, M.D., which were dictated on September 3, 1988, indicate that he had seen the patient in consultation for evaluation of lower gastrointestinal bleeding. The notes disclose that the patient had complained of bloody bowel movements. The notes record a history of diverticulosis and angiodysplasia of the colon. Following a colonoscopy and polypectomy, Petitioner excised the nodule on September 11. The procedure took place at the hospital bed of the patient where her left buttock was prepped and draped in sterile fashion prior to the making of a two-inch incision. Following the removal of the nodule, the area was cleaned, the wound was closed, and sterile dressing was applied. There was no break in technique during the procedureand sterility was maintained. The nodule was later determined to be an area of fat necrosis that had undergone dystrophic calcification. The following day, the patient developed severe respiratory distress and expired. Her final principal diagnoses were anemia secondary to gastrointestinal bleeding, arteriosclerotic heart disease, hypertension, and clostridium with septicemia. A Serious Incident Report was filed on November 29, 1988, and Respondent commenced an investigation on January 11, 1989, to determine if Petitioner's practice was below applicable standards. The first time that Petitioner's case appeared at a Probable Cause Panel Meeting of the Board of Medicine was on May 11, 1990. The following Panel members were present: Chair Robert Katims, M.D.; Marilyn Wells, M.D., and Gilbert Rodriguez. Also present were Assistant Attorney General M. Catherine Lannon and Respondent's attorneys, Carlos Ramos and Stephanie Daniel. At the commencement of the meeting, Ms. Lannon explained the respective roles of herself and Respondent's attorneys. In general, she was present to advise the Panel as to its legal duties under applicable statutes and rules. Respondent's attorneys were available to respond to questions involving specific investigations. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting insufficient time to review them. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file and Respondent's recommendation in the form of a draft administrative complaint or closing order, as appropriate. When Petitioner's case was announced, Mr. Ramos stated that Respondent recommended the Panel find probable cause and direct the filing of an Administrative Complaint. Mr. Ramos explained that the proposed Administrative Complaint alleged that Petitioner practiced medicine below the acceptable level of care when he excised a nodule from a patient's left buttock while the patient was lying on a hospital bed. Also, Mr. Ramos stated, medical records failed to reflect a rectal examination upon admission. Terming it a "terrible case," Panel member Wells moved to find probable cause and issue the Administrative Complaint. Mr. Ramos stated that Petitioner "wasn't sterile." Transcript of May 11 meeting, page 5. Chair Katims asked if Petitioner had surgical privileges. Ms. Lannon responded by restating Dr. Katims' question whether Petitioner may have performed the procedure in a hospital bed because he lacked surgical privileges. Dr. Wells expressed interest in this point. The motion was then passed without further discussion. The materials available to the Probable Cause Panel on May 11, 1990, included a letter dated March 15, 1989,from Joseph R. Goggin, M.D., who is a board certified surgeon. Retained by Respondent to opine as to the standard of care, Dr. Goggin reviewed the file materials and stated in part: I find it hard to believe that the patient's hospital bed in a usual hospital room would be considered sterile. [Petitioner's] statements throughout both the Discharge Summary and in the chart itself state that the wound infection clostridium perfringens and staph coagulase negative was self-inflicted by the patient following the surgical procedure. I cannot believe that this is true. Clostridium perfringens is not a normal flora found in the human colon. Neither is staph coagulase negative. I would suspect that if the patient had contaminated the wound with her own stool, we would have seen mixed cultures with numerous other bacteria involved. One must assume that because of the pure cultures of clostridium perfringens and staph coagulase negative that a break in sterile technique occurred. I think this occurred because the patient underwent the procedure in her hospital bed and not in a sterile operating environment. Dr. Goggin's letter concludes that the hospital changed its policy so that all procedures involving excision be performed in a "completely sterile environment." The letter adds: If this policy was not in place prior to the procedure, I don't believe that the licensee violated the standard of care as it applied to this hospital. However, most of us would believe that any invasive procedure of this nature should probably be performed in a sterile environment. The letter from Dr. Goggin also faults Petitioner for his failure to obtain a rectal examination upon admission of the patient, even though she had been complaining of rectalbleeding. In terms of the timeliness of Petitioner's diagnosis of clostridium, Dr. Goggin concedes, "I don't think that an earlier diagnosis would have changed this patient's final outcome." The records available to the Probable Cause Panel on May 11, 1990, also included a letter from Respondent to Petitioner advising him that he is the subject of a complaint and inviting him to provide a written explanation. In response, and included in the records available on May 11, were a letter dated April 25, 1989, from Petitioner; a statement dated April 25, 1989, from the attending nurse corroborating that sterility was maintained during the excision of the nodule; and a letter dated July 3, 1989, from James J. McClelland, M.D., whose letterhead indicates that he is a member of a group of infectious disease control consultants. Petitioner's letter states that invasive procedures, such as subclavian insertions, chest tube placements, and lumbar punctures for spinal taps, are commonly performed in the hospital bed. The letter restates the procedures followed to maintain sterility and asserts that the contamination had to take place subsequent to the dressing of the wound, such as by the patient inadvertently loosening the dressing through normal movement in the bed. Dr. McClelland's letter states that, following review of the medical records, he finds that Petitioner "followed the normal standard of care in performing this procedure . . .." The letter explains: [C]lostridial infections in sepsis are well reported in the literature to have occurred after many sterile procedures, using standard medical care and that the presence of the clostridial infection does not imply substandard care. It should be noted that clostridial organisms can colonize the skin, often times in higher numbers below the waist, and that this organism entered the wound in the postoperative period. The record showed that [Petitioner] followed the standard care to prevent contamination of the wound by his prep and subsequent dressing of the wound. In regard to the question con- cerning a break in sterile technique and the findings of pure cultures of Clostridium perfringens and staph coagulase negative, it could also [be] assumed that a break in sterile technique would result in multiple other organisms being present in the wound. It should also be noted that the Clostridium perfringens organism can colonize the gastrointestinal tract, as well as the skin, and in itself does not exclude this as a potential pathophysiologic mechanism for her subsequent sepsis. The potential for the woman to have developed this overwhelming infection, whether the surgical procedure was performed in the office, a hospital bed, or the operating room, all exist and cases have been reported associated with all settings. There is no evidence I can see that [Petitioner] deviated from what would be considered normal procedure in removing this nodule from the patient's buttocks. As a result of the deliberations of the Probable Cause Panel on May 11, 1990, Chair Katims executed a Memorandum of Finding of Probable Cause. In the memorandum, the Panel finds that probable cause was found of a violation of Section 458.331(1)(t) and (m). By Administrative Complaint filed August 24, 1990, commencing DOAH Case No. 90-5298, Respondent alleged that thesurgical wound on the left buttock developed pure cultures of clostridium perfringens and staph coagulase negative, "indicating a break in sterile technique." The Administrative Complaint alleges that the patient was admitted with rectal bleeding, but the records fail to disclose that a rectal examination was performed upon admission. The Administrative Complaint alleges that the hospital involved has since changed its policy to require all procedures involving excision to be performed in a "completely sterile environment." Based on the foregoing allegations, Count One of the Administrative Complaint alleges that Petitioner violated Section 458.331(1)(t) by failing to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician when Petitioner excised the nodule in the "environment of [the] patient's hospital bed, which is not a sterile operating environment." Count Two alleges that Petitioner violated Section 458.331(1)(m) by failing to keep medical records--namely a rectal examination upon admission-- justifying the course of treatment of the patient. On September 26, 1990, Respondent filed a motion to amend the Administrative Complaint to delete the allegation about the change in the hospital procedure as irrelevant. The motion was granted. On October 9, 1990, Respondent also filed responses to interrogatories. In support of the assertion that the hospital bed is not a sterile operating environment,Respondent stated that it would rely upon the following witnesses: Petitioner, the attending nurse, Dr. Goggin, and the medical records custodian. In their entirety, the responses disclose that Respondent had not obtained expert advice other than that set forth above. In response to a letter dated December 28, 1990, requesting an opinion and providing all file materials, Respondent's attorney Randolph Collette received a seven-page letter dated January 3, 1991, from E. Rawson Griffin, III, M.D. Dr. Griffin is Board-certified in family practice. After an extensive recitation of the patient history taken by Petitioner, Dr. Griffin traces the subsequent actions of Petitioner, noting that pathological examination of the biopsied tissue detected "no particular serious abnormalities." Dr. Griffin opines: . . . my first opinion is that overall I find that [Petitioner] followed the basic standard of care in doing a history and physical examination, writing progress notes which justified the treatment, provided a surgical procedure in which he documented proper sterilization, surgical technique and postoperative wound care and that he obtained proper informed consent and signed this informed consent. Based on this review, I feel that the standard of care which is outlined in DeGowan and DeGowan's as well as what any reasonable physician would follow, was pretty much followed. The only criticism that I can find is again that there are no progress notes which may have been made by the covering physician. I also found that it was interesting that [Petitioner] did do progress notes on days that other physicians did not and I felt that this indicated that he was following the patient properly. It should also be emphasized that he did a three page dictation which was a discharge summary which basically outlined the facts of the case and I found this discharge summary to adequately summarize the events as they had occurred. In answering specific questions posed to him by Respondent, Dr. Griffin responds affirmatively to the question whether Petitioner met the applicable standard of care in his examination, diagnosis, and treatment of the patient. Dr. Griffin opines that the bedside location of the procedure did not violate the applicable standard of care. In this regard, Dr. Griffin notes the cost-effectiveness of method of treatment, as well as the documentation of proper anaesthesia, preparation of tissue, proper technique, and proper sterile dressings. As to Petitioner's failure to perform a rectal examination, Dr. Griffin notes that a colonoscopy polypectomy was performed. Again referring to the DeGowan and DeGowan treatise, Dr. Griffin observes that, in some cases, a routine or basic examination is inappropriate. One of the primary purposes of a rectal examination is to detect rectal bleeding, but the patient presented with obvious signs of rectal bleeding. Dr. Griffin concludes that a rectal examination by Petitioner might not have produced any more information, so the trauma associated with repeated rectal examinations was unnecessary. Under the circumstances, Dr. Griffin opines that the records justify Petitioner's failure to perform a rectal examination upon admission of the patient. Dr. Griffin also discredits the findings of a Dr.Khouzan who, based upon what he described as a "very careful review of the chart," found "very severe purulent material." Dr. Griffin notes that this finding was contradictory to multiple other chart entries and concludes that Dr. Khouzan did not in fact examine the patient. Respondent's attorney Randolph Collette received a four-page letter dated January 8, 1991, from Stephen J. Nelson, M.A., M.D., whom Respondent had also retained for an opinion by letter dated December 28, 1990. Dr. Nelson is an Assistant Clinical Professor of Pathology at the University of Miami. He is also an Associate Medical Examiner for Broward County and Attending Neuropathologist. Acknowledging the receipt of relevant file materials, Dr. Nelson states: [The patient's] terminal hospital course is an example of anaerobic Clostridium perfrin- gens cellulitis, and probable myonecrosis, following surgery. The onset is sudden, dramatic, and often fatal with an incubation period of 6-72 hours. There are five types of Clostridium perfringens, A-E, separated according to their production of four major lethal exotoxins. The most important exotoxin is . . . (alpha) toxin, or lecithinase-C, because of its lethal, dermonecrotic, and hemolytic activity. Such wounds classically display no pus because the enzyme lecithinase attacks cell membranes and literally dissolves any and all cells (including inflammatory cells) that are in its path. Other Clostridial exotoxins include collagenase, protease, deoxyribonuclease, hyaluronidase, and a hemolysin. Bacteremia is present in about 15 percent of cases. [The patient's] wound is described in multiple places throughout her medical recordas having a serosanguinous drainage. A "thin blood-stained exudate" is the usual classic textbook description. I'm not sure what Dr. N. Khouzan was referring to . . . when he says that his "careful review of the chart revealed a very severe purulent material . . .." His review couldn't have been that awfully careful as there is no mention of "a very severe purulent material," and he incorrectly identified the species of Clostridium he was hoping to treat as being Clostridium tetany (sic) which causes tetanus, rather than Clostridium perfringens which was one of the organisms cultured from [the patient's] excisional wound (along with coagulase-negative Staphylococcal spp.). I can only hope that Dr. Khouzan is not an infectious disease specialist. . . . Dr. Nelson opines that the presence of Clostridium perfringens was not necessarily evidence of substandard care. To the contrary, Dr. Nelson finds that Petitioner, trained as an orthopedic surgeon, "adequately assessed and documented [the patient's] signs and symptoms." Additionally, Dr. Nelson states that Petitioner properly performed the excisional biopsy himself; although devoting his practice to family/general medicine, Petitioner was trained as a surgeon in orthopedics. The bedside site of the excisional procedure did not bother Dr. Nelson, who states that the operating room is "justifiably reserved for more complex procedures." Dr. Nelson questions whether the procedure was performed at bedside or in a nearby "procedure room," where it was scheduled to be performed according to one of the records provided to Dr. Nelson. Dr. Nelson explains that the procedure rooms can easily be prepared for sterile procedures like excisional biopsies. Dr. Nelson's letter concludes: Clostridial spp. are ubiquitous to the human body. They most often become disease-producing and self-perpetuating when the oxygen tension in tissues is lowered, as with an abscess, decubital ulcers, or other cause of tissue necrosis and/or devitaliza- tion. Debilitated patients are at a higher risk of developing Clostridial infections. Intestinal disorders, most commonly malig- nancies, permit Clostridium perfringens invasion and replication, resulting in severe local or, rarely, septicemic Clostridial disease. The most likely source of Clostridium perfringens in [the patient's] excisional biopsy wound is local fecal contamination, though systemic invasion cannot be absolutely ruled out. [The patient] could have developed the infection from an iatrogenic injury during the colonoscopy on 9/4/88 . . . from which the adenomatous polyp was snared. Or from [the patient's] long-standing diverticulosis with the infection spreading from the abdomen to the wound. These are unlikely scenario, given her medical history and hospital course, but it would have been an easy task to have ruled these out by the performance of an autopsy. On January 11, 1991, Respondent requested that the final hearing set for January 29, 1991, be cancelled and the case abated to allow Respondent to return the case to the Probable Cause Panel for reconsideration. In the absence of objection from Petitioner, the motion was granted and the case was abated until March 10, 1991. At the Probable Cause Panel Meeting of the Board of Medicine conducted on February 22, 1991, the following members of the Panel were present: Chair George P. Vitale; Fuad Ashkar, M.D.; and Margaret Skinner, M.D. Ms. Lannon was present, aswere Mr. Ramos, and Respondent's attorneys Larry McPherson, and Susan Londgard. In response to a question posed by Ms. Lannon, each Panel member indicated that he or she had received the written materials concerning matters to be considered at the meeting in sufficient time to review them. Ms. Lannon then invited the Panel members to ask questions or request material if they encountered a case for which they had not read the materials or were otherwise unfamiliar with. Mr. Ramos identified the materials that had been provided to each Panel member prior to the meeting. The materials included the entire investigative file. When Petitioner's case was announced, Mr. Ramos stated that the case was before the Panel for reconsideration after a previous Panel finding of probable cause and the subsequent filing of an administrative complaint. Mr. Ramos explained: We have brought this case back for your consideration, because discovery revealed that two expert opinions state that the Respondent's excision of the nodule in the bedside of the patient was not below the acceptable standard of care. Furthermore, the information related by the patients--by our expert as to the source of the patient's infection is contradicted by recognized medical treatises and the opinion of an infections disease control specialist, and that has been included in the packet. That came after discovery. And, therefore, the Department has recommended that we close this case without further prosecu- tion. Transcript of February 22 meeting, page 7. Panel member Skinner then indicated that she had noticed that the two expert opinions were from a Broward County assistant medical examiner and a family practitioner. She said that she would like to see an opinion from someone who is "Board certified in internal medicine with a subspecialty of infectious diseases, and I would like to see that . . . before we move to do away with this case. This case is heinous . . .." Id. at page 8. Panel member Skinner complained that the experts did not have any medical records and that her records were incomplete. For instance, she said that she did not know the size of the incision or if a nurse documented erythema or "crud" in the wound. She thus moved that the case be brought back with the medical records with an opinion specifically from somebody Board-certified in internal medicine with a sub-specialty in infectious diseases and be brought back to the Panel, because one of the things that is not in the [Administrative Complaint] is failure to recognize [Clostridium perfringens]. Id. at pages 8-9. Ms. Lannon responded that the standard of care would be a reasonably prudent similar physician, "so unless [Petitioner] was Board-certified in infectious diseases, he wouldn't be held to that standard of care. He would be held to the standard of care of a similar physician." Id. at page 9. Panel member Skinner answered that Petitioner is an "orthopedist practicing family practice." Id. Dr. Skinner then asked if Petitioner had surgical privileges at the hospital at which the incident took place. She suggested that the status of Petitioner's surgical privileges could be an "attributing cause." Id. Panel member Ashkar stated that he agreed with Dr. Skinner. Dr. Ashkar noted that one of the materials in the file indicated that the hospital had since changed its policies, or possibly had done so, in terms of excision procedures being performed in a completely sterile environment. In response to a question posed by Ms. Lannon, Panel members Skinner and Ashkar stated that they would proceed with an administrative complaint if they find "it's a standard-of-care violation." Id. at page 11. Dr. Ashkar added that a previous probable cause panel had good cause when it caused the filing of the Administrative Complaint, and the new panel should proceed with it. Dr. Skinner requested that the Administrative Complaint be expanded to include an allegation that Petitioner failed to recognize the presence or possible presence of a staph infection. Dr. Skinner conceded that she did not have the medical records, so she did not know if Petitioner did a wound culture. She also did not have the nurses' notes, so she did not know if they made if obvious that something was wrong with the wound. At this point, Mr. McPherson reminded the Panel that the case had been before a probable cause panel previously. He added that three expert opinions determined that there was "no standard-of-care violation." Id. at page 12. Ms. Lannon disagreed with Mr. McPherson, and Panel members Skinner and Ashkar agreed with Ms. Lannon. Dr. Ashkar stated that Dr. Goggin opined that there was a standard-of-care violation and that the incident forced the hospital to change their policies. Ms. Lannon cautioned that a change in policy would not establish a violation in the first place. Dr. Ashkar responded by referring to the standard-of-care issue and quoting Dr. Goggin as follows: ". . . the patient probably should have had the surgical procedure performed in a sterile environment under the usual conditions found in an operating room suite where there are sterile instruments, and that the wound infection here is probably due to doing it outside that kind of a setting." Id. at page 13. Ms. Lannon asked the Panel what they thought about Dr. Nelson's opinion that Petitioner could be regarded as overutilizing the operating room by performing the excision procedure there. Dr. Skinner admitted that the Panel's problem was that they did not know the size of the excision. She added that the experts differed as to the appearance of the wound, which went toward the failure to recognize a serious problem. Mr. Ramos suggested that the Panel table the case so that Respondent could provide the Panel with the medical records, which everyone agreed had not been included in thepackage supplied to the Board members prior to the meeting. Concluding their discussion of the case at the February 22 meeting, Panel member Ashkar rejected Dr. Nelson's opinion because, absent an emergency, Dr. Ashkar had "never heard of [performing the subject excision procedure in a hospital bed] recently ywayay." Id. at page 16. Dr. Skinner restated her concern about Petitioner's failure to recognize the complication. Ms. Lannon suggested that an orthopedic specialist who had examined the specialist possibly could provide needed information as to the size and nature of the nodule on the patient's hip. The motion was clarified to include consideration of amending the Administrative Complaint to include an allegation that Petitioner failed to recognize timely the patient's clostridium infection and to investigate whether Petitioner had surgical privileges. The Panel voted unanimously in favor of the motion and tabled the case. By Status Report filed March 5, 1991, Respondent advised that the Probable Cause Panel had tabled the case at its February, 1991, meeting in order to obtain additional information. At the Probable Cause Panel Meeting of the Board of Medicine conducted on May 4, 1991, Panel members present were Chair Vitale, Dr. Skinner, and Dr. Ashkar. Mr. Ramos and two of Respondent's investigators were present, as was Assistant Attorney General Edwin Bayo substituting for Ms. Lannon. Each of the Panel members indicated that he or she had read the file materials. When Petitioner's case came up, Mr. Ramos noted that the case had been in front of the Panel "a couple of times," most recently February 22, 1991. Transcript of May 4 meeting, page 4. Mr. Ramos added that one of Respondent's attorneys had pursued all the issues identified by the Panel at the last meeting. Mr. Ramos stated: Discovery reveals that the [Respondent's] expert's opinion was incorrect. That was the initial expert on which we depended on to file an Administrative Complaint. Dr. Nelson and Dr. Griffin have opined since then that the procedure performed in this case does not constitute the practice of medicine below the acceptable level of care. And at our last meeting, the Panel was informed on the foregoing, and it requested that an expert on infectious disease be obtained, and to obtain information as to the respondent's hospital privileges. There's two letters that are part of your packet from the hospital that says the subject did have hospital privileges. And as to the infectious disease person, the only person we have is the one on record, which is on the subject side of this case and [Respondent's attorney] tried to find someone. If you guys know someone for future reference, we need to know about it, because . . . Id. at pages 4-5. Panel members Ashkar and Skinner offered to provide Mr. Ramos with some names. Then Dr. Skinner confessed that she was still troubled about several things involving the case. She again raised the question why Petitioner failed to recognize the serious infection, clostridium perfringens. Sherestated the other issue concerning whether Petitioner was wrong to remove the cyst in the hospital bed. Addressing the first issue, Mr. Ramos said that Respondent could not obtain an expert opinion on whether Petitioner was culpable in his failure to recognize the infection. Dr. Skinner again offered to give Respondent the names of possible experts. Mr. Ramos responded that the process would take time, and, in the meantime, "we have this doctor in this position." Id. at page 6. Dr. Ashkar offered to contact the proposed expert and expedite the process, so the Panel could accept the expert's credentials at the next Board meeting at the end of May. Mr. Ramos said they could move fast on the case, so Dr. Skinner moved to table the case again. Dr. Skinner noted that they needed to consider the issue whether Petitioner improperly incised the abscess at the hospital bed. She asked that Respondent's attorneys pose to the expert two questions: was it below the standard of care to incise the abscess in the bed and was there a failure to recognize a potential danger. Dr. Ashkar distinguished between the removal of a nodule that is a simple ganglion, an ingrown hair, or a sebaceous cyst, on the one hand, and the draining of an abscess with a "very deadly bacteria in it in a general ward," on the other hand. Id. at page 8. Mr. Ramos answered that the case would depend entirely on the expert. The first expert was dated andcontradicted by treatises. Dr. Ashkar responded that it would have been more acceptable if a surgeon without access to an operating room performed the excision in a sterile setting other than an operating room. In any event, it was, in Dr. Ashkar's opinion, improper to perform the procedure in a general ward where infectious diseases are a recurring problem. Id. at pages 8-9. Dr. Skinner agreed that the situation was worse because Petitioner had operating privileges. Dr. Skinner then moved to table the case pending acquisition of expert witness, and again, . . . I would ask him all the ques- tions you asked the other expert witness. Noting that he did have operating room privileges. The second corner of the question that wasn't asked, is, is if it was failure to recognize an additional problem with this wound below the standard of care. Id. at page 10. The Panel then voted unanimously to table the case. Respondent filed a second Status Report on May 20, 1991, and advised that the Probable Cause Panel again tabled the case at its April, 1991, meeting in order to obtain an additional expert opinion. Petitioner objected to further abatement and requested that the case be dismissed. At the same time, Petitioner requested attorneys' fees and costs. By Order Setting Case for Hearing entered June 12, 1991, the request to dismiss was denied, the request for attorneys' fees and costs was denied, and the final hearing resetfor July 15, 1991. By Notice of Voluntary Dismissal filed June 18, 1991, Respondent dismissed the DOAH Case No. 90-5298 and the Division closed its file by Order entered the following day. On July 10, 1991, Respondent received the opinion of another expert, Stephen M. Kreitzer, M.D., who had been retained by letter dated June 26, 1991. In relevant part, Dr. Kreitzer's letter states: The bacteria [to which the patient succumbed] are present in the skin and certainly the elderly with diminished circulation to the skin are more prone to these types of infec- tions. These types of infections can certainly occur under the sterile conditions surgery or they can occur with any break of the skin on their own. It certainly is within the standard of care to remove the type of nodule removed by [Petitioner] in an outpatient center, hospital in-patient bedside, or in a physician's office. There is no evidence to suggest [Petitioner] violated Surgical Infectious Disease Guidelines. . . . Sepsis was recognized by the Emergency Room physician and the care of the septic patient was begun by the Emergency Room physician. [Petitioner] continued that care in the Intensive Care Unit. Appropriate cultures and the broadened spectrum antibiotics were prescribed. In my opinion, the patient contracted the Clostridium and Staph bacteria from unfortu- nate skin entry. Skin entry can occur from an intravenous site, or wound such as that involved with the nodule removal, joint injection by an Orthopedist which occurred during this hospitalization and finally, colonoscopy and polypectomy with mucosal contamination and septicemia. Bacteria induced septicemia have been documented in all of the above instances and is well recognized. . . . Because of the timing of this patient's sepsis, it is unlikely that the trigger point injection or colonoscopy had anything to do with the patient's subse- quent septicemia and demise. Regardless, there is no evidence in the chart that the patient contracted the infection because of the procedure or treatment falling below the standard of care. [Emphasis added.] The applicable standard of care comes into question with this case because of both record keeping and the admitting orders. The patient did not have a history and physical dictated at the time of admission, but rather that was delayed until the 12th of September. Although rectal exam was not included, since the admitting orders included the consultation with the Gastroenterologist who obviously would per- form the rectal exam and colonoscopy, the patient need not have undergone a rectal exami- nation necessarily upon admission. . . . Petitioner subsequently commenced the present case by filing a Petition for Costs and Attorneys Fees on July 29, 1991.
