The Issue Whether Certificate of Need (CON) applications 10386 and 10388 filed by South Broward Hospital District, d/b/a Memorial Regional Hospital (Memorial), to establish a pediatric kidney transplantation program at Joe DiMaggio Children’s Hospital and an adult kidney transplantation program at Memorial Regional Hospital in Broward County, both of which are proposed for organ transplantation service area (OTSA) 4, should be approved. Alternatively, do competing CON applications 10387 and 10389 filed by North Broward Hospital District, d/b/a Broward Health Medical Center (Broward Health), to establish a pediatric kidney transplantation program at Chris Evert Children’s Hospital and Broward Health Medical Center, on balance, better satisfy the applicable statutory and rule review criteria for award of a CON to establish a pediatric or adult kidney transplantation program in OTSA 4?
Findings Of Fact Background AHCA is the state health planning agency charged with administering the CON program pursuant to the Health Facility and Services Development Act, sections 408.031-408.0455, Florida Statutes. Pursuant to Florida Administrative Code Rule 59C-1.044, AHCA requires applicants to obtain separate CONs for the establishment of each adult or pediatric organ transplantation program, including heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestines transplantations. For purposes of determining the need for organ transplantation services, the State of Florida is divided, by rule, into four service planning areas, corresponding generally with the northern, western central, eastern central, and southern regions of the state. “Transplantation” is “the surgical grafting or implanting in its entirety or in part one or more tissues or organs taken from another person.” Fla. Admin. Code R. 59A- 3.065. “Kidney transplantation” is defined by rule 59C- 1.002(41) as a “tertiary health service, “a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost effectiveness of such service.” For purposes of kidney transplantation, a “pediatric patient” is “a patient under the age of 15 years.” Fla. Admin. Code R. 59C-1.044(2)(c). The Applicants The North Broward Hospital District and South Broward Hospital District are special, independent taxing districts established by the Legislature to ensure access to needed medical services to the residents of Broward County. Both districts are governed by respective boards appointed by the Governor. BHMC has a strong and diverse medical staff, including a broad mix of pediatric and adult specialists and subspecialists who provide high quality care to all segments of the community. More than 350 physicians are on BHMC's active medical staff, with the comprehensive medical staff totaling more than 900 professionals. BHMC is a statutory teaching hospital and the flagship hospital of the North Broward Hospital District. CECH is located within BHMC and offers pediatric specialists and subspecialists, including physicians in the areas of pediatric cardiology, pediatric critical care medicine, pediatric emergency medicine, pediatric endocrinology, pediatric gastroenterology, pediatric genetics, pediatric hematology- oncology, pediatric infectious disease, pediatric intensivist, pediatric nephrology, pediatric ophthalmology, pediatric pulmonary, pediatric rheumatology, pediatric surgery, and pediatric urology. The South Broward Hospital District operates MRH, Memorial Regional Hospital South, JDCH, Memorial Hospital West, Memorial Hospital Miramar, and Memorial Hospital Pembroke. MRH is a 777-bed acute care tertiary hospital. It is the flagship facility of the South Broward Hospital District and is one of the largest hospitals in Florida. MRH offers extensive and diverse health care services, including the Memorial Cardiac and Vascular Institute, which features renowned surgeons and an adult heart transplantation program. MRH also includes the Memorial Cancer Institute, which treats more inpatients than any other in AHCA District 10, and Memorial Neuroscience Center, which provides innovative technology and world-class physicians. JDCH is a dedicated pediatric hospital physically connected to MRH. The leadership of both the North Broward and South Broward Hospital Districts were in the midst of transition at the time of the final hearing. Although there was an attempt to suggest that such transitions should be a factor in this CON proceeding, both Districts are stable, well-established providers. Personnel changes, including the replacement of chief executive officers at both Districts, were not an influential factor in this proceeding. The Applicants’ Experience with Transplant Services Broward Health has provided liver transplantation since 2004. Broward Health's liver transplantation program has had higher annual volumes in the past, but is currently offering approximately 12 liver transplantations per year. In total, Broward Health has performed more than 200 liver transplantations since beginning its program. On or about June 23, 2010, Broward Health entered into a five-year contract with the University of Miami (UM) under which UM agreed to provide Broward Health with surgical coverage for Broward Health’s liver transplantation program. Throughout its history, Broward Health's liver transplantation program has offered high quality. During the two most recent surveys, in 2009 and 2012, inspectors with the Centers for Medicare and Medicaid Services (CMS) found that Broward Health's liver transplant program had no deficiencies. Broward Health’s liver program complies with all CMS and United Network for Organ Sharing (UNOS) standards. Broward Health’s liver transplant program exceeds national standards. As of June 2014, 63.3 percent of Broward Health’s transplant patients received a liver transplant within six months of being placed on the waitlist. This is less than half of the national average of 15.3 months. Additionally, Broward Health's mortality rate for liver transplantation is far better than national standards. Memorial established a pediatric heart transplant program in 2011 and an adult heart transplant program in 2014. Memorial's adult and pediatric heart transplant volumes have been relatively low. Memorial has performed a total of 14 pediatric heart transplants over the past five years. In 2012, Cleveland Clinic Hospital (CCH) filed a letter of intent (LOI) and application to establish an adult kidney transplant program. Broward Health submitted a grace period LOI and competing application, No. 10152. Both applications were initially approved and neither was challenged. Accordingly, both programs received final approval by AHCA. After receiving the adult kidney transplant program approval, Broward Health attempted to amend or supplement its liver transplantation agreement with UM to include UM surgical and medical support for Broward Health’s adult kidney transplantation program. Broward Health also applied to UNOS for approval of the adult kidney transplantation program, and identified the UM physicians as those who would provide the necessary surgical support for the program. However, Broward Health never reached an agreement with UM to use its kidney transplant surgeons and did not otherwise recruit the necessary physicians. Broward Health's CEO at that time, Mr. Frank Nask, found UM's proposal to support the kidney transplantation program to be cost prohibitive and decided not to execute the contract amendment with UM. He then instructed staff to dismantle the UNOS-approved kidney transplant program they had already created. Despite the inability to negotiate kidney coverage with UM in 2012, Broward Health continued to offer its adult liver transplantation program using UM surgeons. Had UNOS known that the UM doctors were not available to perform kidney transplants, it would not have approved Broward Health’s adult kidney transplantation program. In March 2014, Broward Health notified CMS, UNOS, and its patients that it was “inactivating” its adult kidney transplantation program. Inexplicably, Broward Health never notified AHCA of this decision. On January 14, 2015, AHCA advised Broward Health that CON No. 10152 had expired and requested that Broward Health return the CON. There is no dispute that CON 10152 has been terminated. Two batching cycles passed from the time Broward Health closed its adult kidney transplantation program until the cycle at issue in these proceedings. In its application for CON No. 10152, Broward Health recognized that an applicant’s prior failure to implement a CON is a proper consideration in the award of future CONs. The application touted Broward Health’s “history of providing transplantation services compared to that of CCH. CCH had an adult kidney transplant program . . . but elected to abandon [it] . . . .” (Memorial Ex. 23, pp. MHS15031-32). Memorial was awarded a CON to establish an adult heart transplantation program at the same time Broward Health was awarded CON No. 10152. Memorial successfully recruited the necessary physicians and staff and implemented that program. The nature of the tertiary services and the two-year planning horizon in this proceeding underscore the importance of applicants being positioned to successfully implement the programs with as little delay as possible. The Applicants’ Proposals Broward Health Broward Health’s proposal relies on the experience it gained through its substantial implementation of its kidney transplantation program in 2012, as well as existing experience and resources related to their adult liver transplantation program. Broward Health acquired significant experience in establishing an adult kidney transplantation program by applying for, and receiving, UNOS approval in 2012. Broward Health's application proposed to hire two abdominal transplant surgeons, Dr. El Gazzaz and Dr. Misawa. The offer to Dr. Misawa, however, has since been withdrawn. Broward Health expects to hire Dr. El Gazzaz. Since the filing of its CON application, Broward Health decided to supplement its surgical coverage by expanding its existing contract with the Cleveland Clinic for liver transplant surgical coverage to include kidney transplantation services should the kidney program receive approval. Broward Health conditioned acceptance of a pediatric kidney transplantation CON on also receiving approval of the adult kidney transplantation CON. Broward Health prepared its financial schedules under the assumption that the adult and pediatric programs were linked, and that both would receive approval. Since livers and kidneys are both abdominal organs, there is substantial overlap in the type of care that is required for transplant patients for each organ. Sometimes both kidneys and livers are transplanted at the same time. Historically, Broward Health has referred out 10 to 15 percent of its liver transplant patients to other providers because it could not offer combined kidney/liver transplantation. Broward Health has accumulated experienced personnel for abdominal transplants. Broward Health's existing nurses care for liver transplant patients and are therefore already prepared to care for kidney transplant patients. Broward Health's team also includes a transplant social worker, transplant psychologist, financial counselors, and quality coordinators. Broward Health plans to hire an additional financial specialist and two Registered nurses (RNs), as well as additional full-time equivalents (FTEs) for a data analyst, pharmacist, and dietician. Broward Health proposes to use the same clinical and ancillary staff for both adult and pediatric kidney transplantation. Unlike Memorial, Broward Health does not intend to perform kidney transplants using live donor organs. Rather, cadaveric organs will be used exclusively. Neither of Broward Health’s applications includes the expense of hiring or contracting for the surgeons needed for its proposed programs. Indeed, there was no evidence that Broward Health’s existing liver transplant surgeons would be willing to perform kidney transplants such that their presence at BHMC or CECH would give Broward Health an advantage in terms of the degree to which its existing services would support its proposed programs. Broward Health has previously developed kidney transplantation policies and procedures related to its 2012 kidney program. These policies and procedures will only require minor updates relative to its later application. Memorial The Memorial adult program would be located at its flagship hospital, MRH. Memorial asserts that it has the requisite staff and resources currently in place to provide expert care to adult patients with chronic end-stage renal disease (ESRD). Memorial points out that staff on the general nursing units and critical care units have extensive experience in the care of patients with chronic kidney disease. Memorial asserts a full range of appropriate inpatient and outpatient services for this patient population on a 24-hour basis including, but not limited to, continuous renal replacement therapy, hemodialysis, and cyclic peritoneal dialysis. Memorial points out that it developed a program to educate staff regarding specific issues related to transplant care (as part of the development of its cardiac transplant program) and that much of this education is relevant to the kidney transplant population. Memorial plans to recruit an experienced transplant surgical director, transplant surgeons, transplant nephrologists and surgical team, and all necessary staff as required. As to Memorial’s proposed pediatric program, the program would be located at JDCH, which is on the campus of, and physically connected to, MRH. JDCH has operated a pediatric nephrology and hypertension program, offering advanced care for children with acute or chronic kidney disorders since 2003. The program is headed by Dr. Alexandru Constantinescu, a board certified pediatric nephrologist. JDCH operates the only pediatric outpatient dialysis unit in Broward County. Dialysis is necessary to sustain the life of a patient with ESRD. With the exception of the actual surgical procedure, JDCH currently provides all the medical care and ancillary services required by pediatric kidney transplant patients, including pre-transplant care, transplant follow-up, and long- term post-transplant care. The only additional personnel JDCH needs in order to implement a pediatric kidney transplantation program is a transplant surgeon and a transplant coordinator, and both are identified in JDCH’s application. JDCH currently refers children who need kidney transplants to other facilities to receive the actual transplant surgery. After transplantation, the patients return to JDCH for their ongoing follow-up care. JDCH’s program also includes a cutting-edge component to transition pediatric transplant patients into the adult clinical setting. Because a transplant patient never ceases to be followed by his or her medical providers, JDCH’s program allows patients to stay within the same institution and to interact with the adult providers during the transition and adjustment period from child to adult. This existing program gives Memorial an advantage over Broward Health with respect to its pediatric and adult applications. In 2006, JDCH became one of five centers that compose the Florida’s Comprehensive Children’s Kidney Failure Center (“CCKFC”) program. JDCH is the only non-academic center approved to provide nephrology care for children with chronic kidney disease who are enrolled in the Department of Health Children’s Medical Services network. In addition, JDCH and Memorial have provided pediatric and adult heart transplantation services since 2010 and 2014, respectively. JDCH’s pediatric heart transplantation program was certified by the CMS in 2011 and was recertified in 2015. CMS certified Memorial’s adult heart transplantation program in November 2015. Memorial has committed to the development and implementation of its pediatric kidney transplant program, regardless of whether its adult program is also approved. The Review Criteria The statutory criterion for the evaluation of CON applications, including applications for organ transplantation programs, is set forth at section 408.035. In addition, AHCA has promulgated a transplantation rule, rule 59C-1.044, which governs the approval of new programs. However, the rule does not contain a methodology that predicts the future need for transplant programs. Instead, the rule sets forth a minimum volume of annual transplants for existing programs that must be met before a new program will normally be approved. The parties agree that the availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in OTSA 4 under section 408.035(1)(a), immediate financial feasibility under section 408.035(1)(f), and costs and methods of construction under section 408.035(1)(i) are not at issue. Section 408.035(1)(a) and Rule 59C-1.044(8)(d): The need for the health care facilities and health services being proposed All parties are in agreement that there is a need for at least one new adult kidney transplant program and one new pediatric kidney transplant program in OTSA 4. However, Broward Health argues that two additional adult kidney transplantation programs could be supported in OTSA 4. Memorial disagrees with this contention. Neither applicant’s need or utilization projections, nor the Agency’s SAARs, considered simultaneous approval of two new adult kidney transplant programs. Broward Health’s applications make no mention of a need for two adult kidney transplantation programs, and do not include any analysis of the impact of approving two programs. Broward Health’s health planning expert, Mark Richardson, acknowledged that “the application basically was put forth to show there was a need for the Broward program. It was silent on whether there is a need for a second or not.” Nothing in Broward Health’s applications address the impact Memorial and Broward Health’s proposed adult kidney transplantation programs would have upon each other or upon existing providers if both were approved. The notion of approving both adult applications would have impacted AHCA’s analysis with respect to a number of review criteria, including utilization of existing programs, availability of resources such as health personnel, extent to which the proposed services will enhance access and competition, and the impact on existing providers. Stated differently, Broward Health’s position at hearing that two adult kidney transplantation programs should be approved would have altered the nature and scope of Broward Health’s adult application, as well as the Agency’s review of both the Memorial and Broward Health adult applications. Memorial’s health care planning and financial expert, Michael Carroll, assessed the applicants’ need projections as well as population growth, the incidence of ESRD in OTSA 4, volumes of existing kidney transplant providers in Florida, and availability of organs. Memorial projects that its programs will perform 30 adult kidney transplants and five pediatric kidney transplants. Mr. Carroll found the projections reasonable based on the number of kidney transplants being performed in OTSA 4, and the recent growth in procedures. No contrary evidence was presented. Mr. Carroll’s analysis confirms the need for one additional adult kidney transplantation program in OTSA 4. In part because kidney transplantation is constrained by the availability of organs, Mr. Carroll opined that only one adult program should be established at this time. Broward Health’s planning expert, Mark Richardson, also reviewed existing volumes, population and discharge data, and information gathered from meetings with Broward Health representatives. He opined at final hearing that OTSA 4 could sustain two additional adult kidney transplantation programs. Mr. Richardson’s opinion is based on the fact that each applicant forecasted 30 adult kidney transplants by the end of year two for what he interpreted as a total of 60 cases. Mr. Richardson argued that, even if two new programs were approved, these figures would satisfy the requirement in rule 59C-1.044(8)(d), that each applicant project a minimum of 15 adult kidney transplants per year by the end of year two. Mr. Richardson’s opinions assume that Broward Health will capture approximately 29 percent of Broward County kidney transplant patients, its current market share of patients discharged with certain renal failure diagnostic codes. In 2013, 97 Broward County residents received kidney transplants somewhere in Florida. Mr. Richardson assumed that if Broward Health captured 29 percent of those patients, they would account for 80 percent of Broward Health’s projected kidney transplant volume, with the other 20 percent resulting from in-migration, for a total of 35 kidney transplants. Mr. Richardson assumed that 30 of those patients would be adults, and five pediatric. The 97 patients in Mr. Richardson’s analysis received both cadaveric and living donor transplants. Broward Health will not use living donor organs at least for the first four years of its programs. Living donor transplants account for 20 to as much as 40 percent of kidney transplants. Mr. Richardson’s methodology therefore cannot be applied to a program like Broward Health’s, which would be restricted to cadaveric donors. The credible evidence of record established that there is a need for one additional pediatric kidney transplantation program and one, not two, additional adult kidney transplantation program in OTSA 4. Section 408.035(1)(c): The ability of the applicant to provide quality of care and the applicant’s record of providing quality of care; Section 408.035(1)(d): The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation; and Rules 59C-1.044(3-4) and 59C- 1.044(8)(a-c) The parties’ disagreement concerning which applications best satisfy the above criteria centered on: (1) which applicant’s existing programs provide a greater degree of support for the proposed programs; (2) the applicants’ ability to recruit the necessary physicians to implement the programs, taking into consideration Broward Health’s failure to implement the adult kidney transplantation program awarded by CON No. 10152; (3) the use of employed versus contracted physicians; (4) the use of living donor organs; (5) the “co- location” of the proposed adult and pediatric programs; and the results of a May 2015 CMS survey of Memorial’s pediatric heart transplantation program. Which applicant’s existing programs provide a greater potential degree of support Broward Health relies heavily on its existing adult liver transplantation program, and the prior approval by UNOS of its now-terminated adult kidney transplantation program, to argue that it is best-suited to operate the adult and pediatric kidney transplantations programs at issue in this proceeding. However, there was no evidence that Broward Health’s existing liver transplant surgeons will perform kidney transplants such that their presence at BHMC or CECH could give Broward Health an advantage in terms of the degree to which its existing services would support its proposed programs. Moreover, liver transplant volume at Broward Health has steadily declined since 2007. The program has never been profitable, and Broward Health has considered discontinuing it. Broward Health also asserts that its experience transplanting livers, which, like kidneys, is an abdominal organ, should be weighed more heavily than Memorial’s experience with heart transplants. According to Broward Health, many staff members from Broward's liver transplant program can simultaneously work with the kidney transplant program, because the two abdominal transplant programs require a similar skill set that is transferrable from one to the other. However, again, given the uncertainty as to the identity of the surgeons who will be performing the kidney transplants for Broward Health, this argument is unpersuasive. Given the history, size, and resources of both hospital systems, the undersigned concludes that the proposed adult kidney transplantation programs are on equal footing as to the support offered by their existing programs. However, given Memorial’s experience with pediatric heart transplant patients, Memorial has an advantage over Broward Health with respect to the pediatric kidney program. As noted by several witnesses at hearing, children are not “little adults,” and therefore a track record of working with children is crucial. The applicants’ ability to recruit the necessary physicians to implement the programs; and The use of employed versus contracted physicians Rule 59C-1.044(4) requires that applicants meet certain staffing requirements, including: ”The program shall employ a transplant physician, and a transplant surgeon, if applicable, as defined by the United Network for Organ Sharing (UNOS) June 1994.” Absent evidence that either applicant had secured the necessary physicians to support its programs, AHCA properly reviewed each applicant’s history of recruitment and establishing transplant programs. Memorial has already successfully recruited physicians and other health care professionals needed to care for ESRD and kidney transplant patients. Its existing transplant programs are operated under the direction of physicians who are employed by MRH. In contrast, for whatever reason, Broward Health was not able to reach an agreement with UM to provide the required surgical and medical support for its previously approved kidney transplantation program, resulting in the abandonment of the program. Memorial’s record of recruiting for, and implementing organ transplantation programs, compared to Broward Health’s record, gives Memorial an advantage in terms of the applicants’ history of providing, and ability to provide, quality of care in organ transplantation. Employed, as opposed to contracted physicians, are more invested in their transplant programs, and provide the hospital with more control in ensuring that the service is implemented and operational. Employing physicians also improves patient safety and outcomes. Unlike Memorial, Broward Health’s existing transplantation program is directed by contracted physicians. Broward Health’s applications state that “two kidney transplant surgeons [are] currently committed to support the proposed new adult and pediatric programs and a third surgeon [is] currently being recruited.” The “two kidney transplant surgeons” are identified in letters of intent, accepted into evidence over a hearsay objection. Neither of the physicians who purportedly signed the letters testified at the hearing. The letters of intent are not binding. Indeed, one of the letters was revoked at the instruction of Dr. Tzakis, the Cleveland Clinic surgeon who serves as medical director for Broward Health’s liver program. The second physician was being recruited for Broward Health’s liver transplantation program; his letter of intent did not address kidney transplantation. It became apparent at hearing that Broward Health’s “plan A” has now become to contract with the Cleveland Clinic to provide professional services, including surgical coverage for the proposed kidney transplantation programs. Memorial’s plan to employ physicians, rather than contract for their services, gives Memorial and JDCH an additional advantage over BHMC and CECH. The use of living donor organs Unlike Broward Health, Memorial will use living donor organs, as well as deceased or “cadaveric” donor organs, in its proposed programs, and its applications include the related costs associated with establishing a live donor program. There are significant benefits to use of living donor organs, including reduction or elimination of a patient’s time on the waiting list, improved recovery times, better patient outcomes, increased organ life, and the possibility of avoiding dialysis, which carries an increased risk of mortality for children. As acknowledged by Broward Health in its application for CON No. 10152, living donor kidney transplantation also has the following “distinct advantages:” instead of occurring on an emergency schedule based upon the availability of a suitable organ, the procedure can be scheduled so as to best accommodate the needs of both recipient and donor, and to minimize organ preservation time. In many instances, the total time from removal of the organ to restoration of blood flow in the recipient can be less than one hour. For these and other reasons, live donor transplants typically result in better quality of life and longer survival rates for recipients. (Memorial Ex. 23, p. MHS15056). Memorial’s plan to use living donor organs gives it an advantage over Broward Health in terms of its ability to provide quality of care in pediatric and adult kidney transplantation. The “co-location” of the proposed adult and pediatric programs Especially for pediatric patients nearing the transition to adult care, there are significant benefits in “co- locating” adult and pediatric transplant programs, i.e., one provider operating both programs. For example, co-location allows pediatric patients to transition into the adult setting with providers they trust, reduces the patient and family’s stress, and improves quality of care. In addition, some resources from adult and pediatric kidney transplantation programs can be shared if they are co- located, which improves the programs’ financial feasibility. These factors weigh in favor of granting both pediatric and adult programs to one provider, if appropriate. The May 2015 CMS survey of Memorial’s pediatric heart transplantation program Broward Health’s primary attack against Memorial with respect to sections 408.035(1)(c) and (d), centered on the results of a May 2015 CMS survey of Memorial’s pediatric heart transplantation program. The survey found numerous deficiencies, including deficiencies related to patient safety. CMS notified Memorial that the deficiencies were substantial enough to warrant terminating the program if not immediately corrected. CMS notified Memorial that the program would be terminated unless the deficiencies were cured within 45 days. In response to the survey, Memorial hired an outside consultant, Transplant Solutions. Transplant Solutions conducted its own survey and identified the same deficiencies noted in the CMS survey. Even after Memorial implemented its corrective action plan, CMS found additional deficiencies, though the new deficiencies were not sufficient to warrant termination of the program. Barbara Sverdlik, Director of Nursing and Transplant Administrator at BHMC, compared the lack of deficiencies in the 2012 survey of Broward Health’s adult liver transplantation program with the results of the May 2015 survey of JDCH’s pediatric heart transplantation program. As Ms. Sverdlik acknowledged, JDCH ultimately passed its 2015 survey and, in spite of the results of the initial survey, “[JDCH] could offer a good quality [pediatric kidney transplantation] program.” Although concerning, it is not entirely surprising that numerous deficiencies were found in Memorial’s relatively new pediatric heart transplant program. However, it is more significant to the undersigned that Memorial took immediate action to correct those deficiencies in order to ensure that the program continued without interruption. JDCH’s May 2015 Survey therefore does not give Broward Health any advantage or Memorial any disadvantage under the review criteria. Section 408.035(1)(e): The extent to which the proposed services will enhance access to health care for residents of the service district Three primary considerations were identified at final hearing relevant to which applicant’s proposed programs are more likely to enhance access: the commitment of each applicant to the proposed programs; the availability of donor organs at each facility; and the availability of services at each facility. Access is significantly enhanced by the use of living donor organs, not only for the living donor recipient, but also for other potential transplant recipients on the wait list. The 20 to 40 percent of kidney transplant patients who could receive a living donor transplant would not have access to kidney transplantation at Broward Health for at least the first four years of its programs, whereas those same patients would have immediate access to the needed services at Memorial. In this regard, and as acknowledged by witnesses for the Agency and Broward Health, Memorial’s programs would enhance access to needed kidney transplantation services to a significantly greater extent than Broward Health’s. In its applications and at final hearing, Broward Health touted its existing adult liver program as providing a foundation for its proposed kidney transplantation programs. However, just five percent of liver transplant recipients require a simultaneous liver and kidney transplant. Any access advantage Broward Health might claim to patients requiring dual transplantations is outweighed by Memorial’s use of living donor organs which impacts a much larger percentage of transplant patients. It is uncontroverted that Broward Health abandoned its prior adult kidney transplantation program, thereby exacerbating the access challenges that exist in OTSA 4 with regard to kidney transplant services. Also, despite a recognized need for a pediatric program, Broward Health’s pediatric application was conditioned on the award of the adult program; it “will not be developed as a stand-alone pediatric kidney transplant program.” (JE 12, p. BH83). The adult program is really Broward Health’s focus, and this is evident even in Broward Health’s financial and staffing projections. As established through the final hearing testimony of their CEOs, MRH and JDCH are steadfastly committed to establishing pediatric and adult kidney transplantation programs. It is also noteworthy that JDCH operates the only pediatric outpatient dialysis program in Broward County, again highlighting its commitment to the pediatric population suffering from kidney disease. In contrast, the proposed Broward Health program would rely on a third party, DaVita, to provide pediatric outpatient dialysis. As the applicant which is more committed to provide the needed services to both the pediatric and adult populations, and which has an unblemished track record of implementing programs, Memorial would enhance access to pediatric and adult kidney transplantation services in OTSA 4 to a greater extent than Broward Health. At hearing, Marisol Fitch, the Agency representative, explained why AHCA concluded that as between the two applicants, Memorial would be most likely to enhance access to this needed service: Q So as between these two applicants, one telling you that if you don’t give them a CON for an adult program, they are not going to implement a CON for the children’s program, versus the other one, which of these two applicants would best ensure and enhance access for residents of this area of the state? A If you are talking about all residents, including the pediatric population, then it would be the applicant that was going to do both. Q That’s Memorial; isn’t that right? A They did not condition their application on – they would do the pediatric without the adult. Q Now I will ask you the same question regarding the issue of the live donor program. One applicant is indicating they will not establish and operate a live donor program, the other one will. Of the two applicants, which would enhance access to the residents of the district that we are dealing with here? A The applicant that used live donor since a large chunk of donors for kidneys are live donors. Q That would mean Memorial; isn’t that right? A That is correct. Section 408.035(1)(f): The immediate and long-term financial feasibility of the proposal The parties have stipulated that short-term financial feasibility, the ability to fund and open the projects, is not at issue. However, the parties contested the long-term financial feasibility of each proposal. The Agency’s application review concluded that the proposed programs were financially feasible in the long-term. That conclusion presumed that the assumptions underlying the applicants’ financial figures were appropriate. In Schedule 8A of its pediatric application, Memorial projected a net loss of $1,129,885 in its second year, while Broward Health projected a net excess of revenue over expenses of $200,717 at the end of year two. In Schedule 8A of its adult application, Memorial projected a net loss of $589,691 in its second year, and Broward Health projected a net excess of revenue over expenses of $560,709 at the end of year two. According to Broward Health’s financial consultant, Tom Davidson, the primary reason Broward Health’s financial projections appear more favorable than Memorial’s is because Memorial’s applications include the costs of required transplant physicians, while Broward Health’s do not. As Mr. Davidson testified at hearing: Q How can you explain that difference? Have you analyzed the two pro formas to figure out why Broward Health projects it can make money at a lower volume than what you think Memorial Health would do to break even? A Yes, I mean it’s entirely – not only in the pro formas, but actually in the real world, it is a function of the physician expense. This is kind of an interesting case from a financial feasibility point of view because there is really only one issue that needs to be analyzed. You have two applicants in the same county, both tax- supported programs that provide a lot of charity care. They both want the same service, they are both projecting the same volume. Every line item in the real world, forget about what’s in the pro formas, but when the real world comes around, whatever goes on in terms of payer mix, gross charges, and in particular net revenues with Medicare and Medicaid and commercial insurers, all those numbers are just going to be what they are. They are going to have to spend the same money to take care of the transplant patient. There is nothing really that a sensible human being could bring up that would distinguish the two in terms of financial feasibility except for this one issue. Does one hospital have to hire a bunch of new doctors to get into business or do both? Broward Health represented to me and I represented in the financial projections that I prepared that they would not. Memorial represented in their forecasts that they would. And that’s the entire difference. And it’s really the only difference that there can be between these two applications. Because otherwise, if you just think about it logically – you don’t have to be a finance person – there’s no – you can’t slip a piece of paper between these two programs in terms of revenues, expenses, and other expenses, because you’ve got to take care of patients. You have to give them lab tests and things cost what they cost. So without getting into some really kind of bazaar attempts to distinguish these two, that’s the question. And I think as a health planner it is my firm opinion that that is the only thing on the financial side that Your Honor has to consider, whether or not Broward Health has to hire doctors. Originally, Mr. Davidson included approximately $900,000 in his expense projections for the cost of adding two physicians. He later eliminated those expenses by assuming that the surgeons currently performing adult liver transplants would also perform Broward Health’s adult and pediatric kidney transplants at no additional cost. Broward Health’s applications do not include any costs associated with employing or contracting for physicians needed to operate its programs and Broward Health does not know what the financial terms of either arrangement might be. As acknowledged by Robyn Farrington, Chief Nursing Officer at BHMC, Broward Health will need additional physicians beyond those who are already either employed or contracted by Broward Health in order to operate adult and pediatric kidney transplant programs. As Michael Carroll credibly testified, even assuming the surgeons performing liver transplants at BHMC also performed kidney transplants at no additional cost, it is improper to exclude the costs for those physicians from a financial assessment of the kidney program: “whatever time that liver transplant surgeon spends [performing kidney transplants] should be allocated to the kidney transplant program.” Broward Health’s pediatric application also failed to include any additional staff for the proposed project. This is because, unlike Memorial, the financial and staffing projections in Broward Health’s applications are interdependent: the staffing and expenses in Broward Health’s pediatric application assume that Broward Health is awarded the CON for an adult program and that, in large part, the adult program would support the pediatric program without the need for additional resources. Accordingly, no expenses associated with adding staff is reflected on Schedule 8A of Broward Health’s pediatric application. However, since children are not simply small adults, additional staff would, in fact, be required for Broward Health’s pediatric program. If its pediatric application is approved, Broward Health will then evaluate what additional staffing it might need for its program. However, as of now there is no way to determine from its applications what staff Broward Health will need for its pediatric program or what the additional cost of that staff will be. In short, there is no way to forecast the cost of either of Broward Health’s proposed programs. The uncertainty regarding the ultimate cost of the Broward Health programs contrasts with Memorial’s applications, which were presented as “stand-alone” projects with regard to projected costs. All resources necessary to operate the adult and pediatric kidney transplantation programs are included in each application. Notwithstanding the stand alone financial presentations, it is reasonable to assume that some resources will be shared if Memorial receives final approvals for both programs. As pointed out by Broward Health, Memorial’s applications contained four mathematical errors that impacted its financial projections. Specifically, Memorial included an incorrect number of adult transplants to be performed prior to CMS certification, improperly calculated Medicare reimbursements, overstated organ procurement costs, and included too many post-transplant follow up appointments. Memorial prepared corrected financial schedules to account for these errors. Revised Schedule 8A for Memorial’s adult application showed a net excess of revenue over expenses of $745,434 at the end of year two. Revised Schedule 8A for Memorial’s proposed pediatric program showed a net loss of $1,026,422 at the end of year two. The combined net loss at the end of year two for both programs totals $280,988. The errors did not affect Memorial’s volume projections, the programs’ scope, orientation, philosophy, accessibility, or need assessment. Memorial has the financial ability to absorb the losses for its proposed pediatric program, even if operated as a stand-alone program. If Memorial’s adult and pediatric programs are co- located, some resources will be shared, and the combined programs will approach break even by the end of year two. In this case, long-term financial feasibility is not accorded as much weight as it might be in other CON determinations, because there is an established need for these tertiary services, and both applicant organizations have the ability, if they so choose, to subsidize operational losses in order to maintain the programs. Stated differently, the projected long-term financial feasibility of both applicants’ proposals is not a basis for distinguishing between them. Rather, the commitment of the applicants to their proposals, as addressed above, is the more critical consideration. Section 408.035(1)(g): The extent to which the proposal will foster competition that promotes quality and cost- effectiveness The Cleveland Clinic is an existing provider of adult kidney transplantation services in OTSA 4. If Broward Health’s “plan A” is implemented, a contract with the Cleveland Clinic for surgeons to operate an adult kidney transplantation program in the same county and OTSA is less likely to foster competition that promotes quality and cost-effectiveness than approval of Memorial’s independent programs. Broward Health’s proposals will not foster competition for pediatric or adult living donor transplants. These considerations weigh in favor of Memorial with respect to the ability of both its proposed adult and pediatric kidney transplantation programs to foster competition pursuant to section 408.035(1)(g). Section 408.035(1)(i): The applicants’ past and proposed provision of health care services to Medicaid patients and the medically indigent Consistent with their missions, both applicants provide substantial services to Medicaid patients and the medically indigent. Mr. Richardson was critical of Memorial’s applications because they do not include Medicaid in their projected payor mix. However, Mr. Richardson’s data showed a miniscule percentage of Broward County residents who received a kidney transplant and are Medicaid-eligible. And although Medicare makes up a far larger portion of the payor mix, Broward Health’s pediatric application included no Medicare in its payor mix assumptions. As Mr. Davidson testified, it is improper to draw any conclusions from an applicant excluding Medicaid as a payor source or from the fact that Broward Health did not include any bad debt or charity care in its applications. As Mr. Richardson agreed, Memorial provides a large volume of Medicaid care and the pediatric applications are on equal footing on this criterion. Mr. Richardson also correctly agreed that the applicants are the same in terms of their history of serving Medicaid and medically-indigent adult patients. There is no evidence that either applicant has a greater commitment to providing kidney transplantation services to Medicaid patients and the medically indigent than the other. Accordingly, neither applicant is entitled to preference under this criterion.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered approving CON Application Nos. 10386 and 10388 filed by the South Broward Hospital District, d/b/a Memorial Regional Hospital, subject to the conditions contained in the applications, and denying CON Application Nos. 10387 and 10389 filed by the North Broward Hospital District, d/b/a Broward Health Medical Center. DONE AND ENTERED this 4th day of May, 2016, in Tallahassee, Leon County, Florida. S W. DAVID WATKINS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 2016.
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations that Respondent violated the provisions of Subsections 458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient M.R., as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of medicine 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 in the State of Florida, having been issued license number ME 0077248. Respondent is a vascular surgeon, who is not board-certified in his area of practice. On November 27, 2000, Patient M.R., a 70-year-old male, was admitted to ORMC for a right-side carotid endarterectomy. Patient M.R. initially presented to Respondent in October 2000 with a number of health conditions, including chronic obstructive pulmonary disease (related to a 54-year history of smoking), cerebral vascular disease, atherosclerotic changes, and hypertension. Patient M.R. had a significant cardiac condition which resulted in a bypass procedure. It was determined at that time that Patient M.R. had significant stenosis in both carotid arteries which would require Patient M.R. to undergo two separate procedures, known as carotid endarterectomies. The left carotid artery was the subject of the first procedure in October 2000. Patient M.R. tolerated this procedure with no complications. Subsequent to the first carotid endarterectomy, but prior to the second, Patient M.R. suffered a transient ischemic attack (TIA), which is commonly referred to as a "mini-stroke." The symptomatic clinical presentation placed Patient M.R. in a high-risk category for peri-operative stroke. Respondent performed a right carotid endarterectomy on Patient M.R. on November 27, 2000. This requires the clamping of the artery in two locations, using a shunt to allow for the flow of blood. The incision must be made length wise in the controlled portion of the artery using an instrument to clear out the interior or lumen of the artery. This is done to reduce the stenosis and allow for better blood flow, without disbodying any particle from the wall of the artery. Once this is completed, the incision is patched, the clamps and shunt are removed, and the outer skin incision is closed. During the course of the above-described carotid endarterectomy, Respondent used a patch angioplasty with intra- operative shunt, which was manufactured from a pediatric feeding tube, and peri-operative neurologic monitoring. Immediately after the operation, the patient appeared to tolerate the procedure well, but was lethargic. Patient M.R. exhibited good movement in all four extremities and appeared to be neurologically intact, although he underwent extreme fluctuation in blood pressure. Patient M.R. was placed on ventilator support. The next morning, November 28, 2000, Patient M.R. had swelling and a hematoma in his neck on the right side, in the area of the incision. Respondent returned Patient M.R. to surgery, for exploration and evacuation of the hematoma. During the course of this second operation, Respondent observed a lot of swelling and edema in the operative site, but not much blood. Respondent evacuated the hematoma, and the carotid artery was found to have good blood flow. Later in the evening on November 28, 2000, Patient M.R. developed an acute neurologic deficit and was returned to the intensive care unit (ICU) at ORMC. Respondent ordered a Computerized Tomographry Scan (CT Scan) of the patient and an arteriogram. The results of the CT Scan showed a probable right occiptal infarct (stroke). The arteriogram showed significant occlusion of the right carotid artery extending to the carotid siphon. Patient M.R. was returned to the operating room in the early morning hours of November 29, 2000. Respondent made the decision to reopen the surgical area in an effort to resume blood flow in the right carotid artery that was seen to be occluded on the angiogram. Assisting Respondent on this November 29, 2000, procedure were John Horowitz, M.D., a board- certified vascular surgeon with nine years of experience, and Joseph Muller, M.D., a third-year general surgical resident at ORMC. During the November 29, 2000, procedure, Respondent reopended the previous incision in the skin and partially opened the patch that had previously been used over the carotid artery itself. Respondent performed a thrombectomy using a Fogarty "balloon" catheter in an effort to extract any debris that was causing the stenosis in the carotid artery. The balloon is placed into the carotid artery itself and is pushed up into the artery until it has passed whatever occlusion is present. Then the balloon is inflated and pulled back out, pulling with it any debris that is located within the artery. Near the conclusion of this November 29, 2000, procedure, a small piece of tubing was discovered in the surgical field. The piece of tubing was handed to Dr. Horowitz, who examined it and then placed it on the surgical tray. This piece of tubing was the same size, slope, and material cut from the feeding tube which was used as a shunt in the first surgery on November 27, 2000. There is conflicting testimony regarding the precise size and location of this piece of tubing that will be discussed below. What remains undisputed based upon the record in this case is that Respondent completed the surgical procedure on November 29, 2000, by closing the incision in the carotid artery and also in the skin of the neck. Dr. Muller is currently a surgical resident at ORMC, as he was at the time of the November 29, 2000, procedure. Dr. Muller testified that he had approximately two years and five months of residency training prior to the procedure in question. He estimated that he had observed approximately ten to 15 carotid endarterectomies. Dr. Muller testified that he observed a clear and slightly opaque piece of pediatric feeding tube coming out of the lumen of the artery as Respondent was evacuating debris after the inflation of the Fogarty balloon catheter and after about three passes of the catheter. Dr. Muller also testified that the piece of tubing in question was two or three centimeters in length. The other witnesses to this event testified that the piece in question was two to three millimeters in length. Dr. Muller's description of the position of the surgeon and assistant surgeon was also contrary to that of the other witnesses. Dr. Muller also testified that he did not know Patient M.R.'s medical history or his previous hospital course of treatment. Dr. Horowitz, the senior physician assisting, is a board-certified vascular surgeon who has performed several hundred carotid endarterectomies. He testified that he was called in by Respondent to assist on the surgical procedure which took place in the early morning hours of November 29, 2000. He found the piece of tubing located somewhere within the surgical field, remote from the carotid artery. He was certain that it was after Respondent had cleared the artery with the use of the Fogarty balloon catheter and had cleared the surgical wound. Dr. Horowitz testified that he saw a piece of tubing among the debris that had been evacuated from the surgical wound. It was not in the lumen of the artery. He picked up the piece of tubing in question with his thumb and forefinger and examined it. He testified that it was approximately two to three millimeters in length. He agreed that the material was consistent with the pediatric feeding tube that was used to create a shunt for the first procedure. Dr. Horowitz's testimony is credible and persuasive. Dr. Horowitz also gave his opinion that based upon his observation of the November 29, 2000, procedure, he did not believe that Respondent deviated from the standard of care in his treatment and care of Patient M.R. Patient M.R. was returned to the ICU, where he deteriorated and showed evidence of complete lack of brain stem reflexes. Patient M.R. was later pronounced brain dead, and he subsequently died on November 30, 2000. Gregory Schreiber, M.D., was the anesthesiologist who was present for a portion of the November 29, 2000, procedure. Dr. Schreiber testified that he was present during the beginning portion and the end portion of the procedure, when anesthesia is introduced and when anesthesia is abated. He was not present in the operating room when the piece of tubing was found. Further, there was a drape that separates the operative field from the anesthesiologist during the course of this procedure, which would have prevented Dr. Schreiber or his assistant from being able to see into the operative field directly. Dr. Schreiber noted that Patient M.R. was considered a very high-risk patient, whose multiple co-existent diseases posed a constant threat to his life when he presented for this surgery. In addition to the testimony outlined above, Petitioner also introduced three affidavits into evidence. One affidavit was that of Lata Bansal, M.D., a neurologist who was brought in for consultation after the November 29, 2000, procedure. Dr. Bansal swore in her affidavit that when she first saw Patient M.R. he was already brain dead. She otherwise did not have specific recollection of Patient M.R. The affidavit of Peter D. Taylor, M.D., a cardiac specialist, stated that he recommended a Thallium stress test for Patient M.R. prior to carotid surgery. The stress test was conducted on October 17, 2000, and revealed no ischemia but moderately decreased left ventricle function. Because he had no ischemia, Dr. Taylor opined that Patient M.R. was at an increased but acceptable risk for carotid surgery. The affidavit of Marita Lu, Registered Nurse, who was present during the November 29, 2000, procedure, stated that she could remember very few details of Patient M.R.'s case, other than she has the "impression" that something was recovered from the wound and that when she asked whether there was a specimen, she was told there was no specimen. Nothing in her affidavit indicates to whom she asked this question regarding the specimen nor is there any indication who responded to her question. Respondent is a board-certified general surgeon who is eligible for a special certification in vascular surgery and who was working at a vascular surgery group in Orlando, Florida, as of October and November of 2000. Respondent no longer practices in the State of Florida. He currently is an assistant professor of surgery and director of endovascular surgery at Creighton University in Omaha, Nebraska. Respondent described in detail each of the three procedures he performed. On November 27, 2000, the original procedure on the right carotid artery proceeded in routine fashion. Respondent provided an exemplar, which was admitted into evidence, of a pediatric feeding tube which is substantially similar to the pediatric feeding tube utilized in the November 27, 2000, procedure on Patient M.R. He utilizes a portion of the pediatric feeding tube as a shunt in his carotid endarterectomy procedures. He demonstrated at the final hearing that the pediatric feeding tube itself is so flexible as to be incapable of breaking. The only means of cutting it down is through the use of surgical instruments. He also indicated that there was no way to further cut down the tubing once it had been placed. The scrub technician cut the pediatric feeding tube into the appropriate length to be used as a shunt during the November 27, 2000, procedure. Respondent recalled that prior to this particular procedure, the tubing in question was not originally cut down to the appropriate size. It had to be cut down while in the operating room. It is during this cutting of the tubing that a tiny sliver, approximately two to three millimeters in length, was removed from the larger piece of tubing and entered the surgical field. Respondent did not know and did not have any way of knowing that the piece of tubing had entered the surgical field, as he was focused on preparing the artery itself for its incision while this tubing was cut. Respondent testified that the pediatric feeding tube in question was cut down to size before any incision was made in the carotid artery itself. Respondent performed the November 27, 2000, procedure as he normally does. After the procedure, Patient M.R. experienced extreme fluctuations in blood pressure. This can occur in patients due to multiple factors involving the nervous tissue and blood flow in the carotid artery, but there is no specific explanation for why it does happen. Subsequent to the November 27, 2000, procedure, Respondent monitored Patient M.R., addressing the extreme fluctuations in blood pressure along with the consulting physicians referred to above. Respondent noted that Patient M.R. developed a hematoma subsequent to the first procedure. He made a determination that the best course for Patient M.R. would be to evacuate the hematoma. In Respondent's opinion, evacuating the hematoma would speed up the healing process. Respondent performed this procedure on November 28, 2000. Patient M.R. tolerated this procedure well, and there was nothing remarkable about the procedure itself. Respondent palpated Patient M.R.'s artery during the course of this procedure and used the Doppler to reinforce his findings on palpation. A Doppler signal gives more specific information about the varied nature of blood flow in the internal and external carotid arteries. It was not Respondent's standard practice, nor is it necessary, to create a medical record that palpation of the artery has occurred, since it is such a basic and common occurrence that its notation on the record is not deemed to be necessary. Respondent continued to follow Patient M.R. subsequent to the November 28, 2000, procedure. When it was determined that Patient M.R. had suffered a stroke, Respondent was left with a choice of either doing nothing, or reopening the artery in an effort to save Patient M.R.'s life. Respondent chose to reopen the artery in an effort to determine whether anything could be done to save Patient M.R. Respondent opened the prior incision in the carotid artery on November 29, 2000, and inserted the Fogarty catheter in order to evacuate any debris that was located within the carotid artery. Respondent testified that it was at about this time that the piece of tubing was found; however, he further testified that he did not see the tubing in question come from the lumen of the carotid artery. Respondent's testimony is credible. It was Respondent's opinion testimony that the piece of tubing in question was located in the subcutaneous tissue outside of the artery. Its exact location within the various layers of subcutaneous tissue was not observed during the procedure. It was not possible for the piece of tubing in question to have entered the artery at this time. There was no evidence to suggest that the piece could have migrated into the artery at a later time. James Dennis, M.D., is a board-certified vascular surgeon who is the chief of the vascular surgery department at the University of Florida in Jacksonville, Florida. Dr. Dennis has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Dennis testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient M.R. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient M.R., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes. Dr. Dennis also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient M.R. Dr. Dennis' standard of care opinions were based on several factors. First, it was Dr. Dennis' opinion that based upon the contents of the chart, the only time that the piece of pediatric feeding tube could have entered Patient M.R. was during the course of the November 27, 2000, procedure. Dr. Dennis testified that in his opinion, Respondent deviated from the standard of care in allowing the piece of pediatric feeding tube to enter Patient M.R.'s body. This would be his opinion even if Respondent did not see the sliver of tubing in question enter Patient M.R.'s body and even if the piece of tubing in question were so small and translucent as to be practically invisible. Dr. Dennis also testified that in his opinion, Respondent deviated from the standard of care during the November 28, 2000, procedure in that he failed to adequately palpate the carotid artery. Dr. Dennis was critical of Respondent's use of a Doppler to assess Patient M.R.'s pulse. In Dr. Dennis' opinion, the use of the Doppler was indicative a weakening pulse rate and that the proper practice would have been to palpate the artery by touch rather than by using a Doppler instrument. Dr. Dennis was also critical of Respondent during the November 28, 2000, procedure for his failure to find the piece of tubing in question. It is Dr. Dennis' opinion that the piece of tubing had to have been located within the lumen of the artery and that had Respondent adequately palpated the entire length of the carotid artery during the November 28, 2000, procedure, he would have located the piece of tubing within the artery and could have taken appropriate steps to remove the piece of tubing before Patient M.R. suffered his stroke later that night or during the early morning hours of November 29, 2000. Dr. Dennis' opinion that the piece of tubing in question had to have been located in the lumen of the artery was also based upon his assessment of the procedures performed. He discounted the theory that the piece of tubing was located within subcutaneous tissue outside of the artery because, in his opinion, the piece of tubing would have been discovered either during the November 28, 2000, procedure or earlier in the November 29, 2000, procedure if it had been outside the artery. However, according to Dr. Dennis, based upon the timing of when the piece of tubing was found, the tubing itself had to have been located within the lumen of the artery until it was removed in the November 29, 2000, procedure. Dr. Dennis also rendered the opinion that not only was the piece of tubing located within the lumen of the carotid artery, but that the piece of tubing is directly related to the stroke which Patient M.R. suffered later that day or the following morning, which caused his death. Dr. Dennis testified that the piece of tubing became lodged in Patient M.R.'s carotid artery and that as blood flowed by it, platelets attached to the tubing, slowly building up with the carotid artery, until Patient M.R. experienced 100 percent stenosis in the right carotid artery, leading to his stroke. In sum, Dr. Dennis' opinion was that Respondent deviated from the standard of care by allowing a piece of tubing to enter Patient M.R.'s carotid artery and that it was this tubing which lead to Patient M.R.'s stroke and ultimately his death. This is in spite of the fact that Dr. Dennis was not able to state within any degree of medical probability how the sliver of tubing could have entered the artery. Dr. Dennis also rendered an opinion during his final hearing testimony that Respondent deviated from the standard of care because he did not secure the piece of tubing at issue in this case and see to it that the tubing was sent to the pathology laboratory at ORMC for analysis. Morris Kerstein, M.D., a board-certified vascular surgeon, reviewed all of the pertinent medical records reflecting the treatment and care Respondent provided to Patient M.R. Dr. Kerstein had been practicing for 35 years, and he is currently the chief of the vascular surgery department at the Veteran's Administration Hospital in Philadelphia, Pennsylvania. Dr. Kerstein has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Kerstein's opinion based upon his education, training, and experience is that Respondent did not deviate from the standard of care in his treatment of Patient M.R. First, Dr. Kerstein testified that in his opinion, Respondent's conduct during all three procedures at issue was appropriate. As to the November 27, 2000, procedure, there was no way for Respondent to be aware that the piece of pediatric feeding tube had entered the operative field. It was too small to be noticed, and it was of a translucent color which made locating it extremely difficult. He was not critical of Respondent for not cutting the tubing himself. He testified that if, in fact, the sliver of tubing entered the surgical area as a result of the scrub technician cutting the tubing, and a two to three millimeter fragment jettisoned into the surgical field, this would not constitute a deviation from the standard of care by Respondent. Dr. Kerstein testified that he felt the November 28, 2000, procedure was performed appropriately as well. He testified that it was not a deviation for Respondent to use a Doppler to feel for pulses in the arteries, and to the contrary, it reveals that Respondent was being meticulous beyond what the standard of care requires. He opined that Respondent certainly would have palpated the arteries in question, and to suggest otherwise based on the absence of a note to that effect is not an appropriate conclusion to draw. Dr. Kerstein rendered the opinion that he did not believe that the piece of tubing in question was located within the lumen of the artery of Patient M.R. He testified that there was no way for the tubing to enter the artery because the sliver in question came off of the longer tubing before an incision was made in the carotid artery. There is therefore no reasonable explanation as to how the piece in question could have entered the carotid artery in the first place. Dr. Kerstein also disputed the theory that not only was the piece of tubing located within the lumen of the artery, but also the piece in question actually caused Patient M.R.'s stroke. Dr. Kerstein relied principally on the radiographic studies. Both the CT Scan of the brain and the angiogram taken late in the evening of November 28, 2000, revealed a right posterior occipital infarct. The posterior of the brain is the back of the brain, and if the infarct was located there, it means that the cause of the stroke had to be something other than an occlusion in the carotid artery. This is because the arteries that feed the back portion of the brain are the basilar and vertebral arteries, not the carotid artery. Therefore, there could be no possible causal connection between the sliver in question and Patient M.R.'s stroke. Dr. Kerstein's opinion as to the cause of Patient M.R.'s stroke focused on his personal history rather than on the events of November 27, 2000. He noted that Patient M.R. presented with severe atherosclerotic changes, indicative of an advanced disease process. He noted that Patient M.R. suffered from chronic obstructive pulmonary disease, which was the product of his 54-year smoking history. He also noted Patient M.R.'s significant cerebrovascular disease. He also stated that thrombosis (or clotting of the blood) is a known complication of this procedure and can happen for several plausible reasons other than a sliver of tubing in the artery. All of these conditions conspired to predispose Patient M.R. to suffer a significant event such as the stroke he suffered on November 28 through 29, 2000. Dr. Kerstein also noted that the piece of tubing was completely inert, and given its size and its location in the subcutaneous tissue outside of the carotid artery, the tubing would have had no impact whatsoever on Patient M.R.'s prognosis. The tubing in question is an example of inert material that can remain inside the body, such as the case of a bullet which is located too close to the spinal cord to allow for an operation to remove it, without causing the body any harm. Dr. Kerstein had no criticism of the medical records Respondent kept regarding the treatment he provided to Patient M.R. He specifically noted that the records were accurate and honestly reflected what had occurred during the procedure. The fact that no foreign object was noted in the first two procedures was appropriate because at that point, he had no reason to suspect the presence of a foreign object. The lack of reference to a cause of Patient M.R.'s atypical post-operative course was appropriate because in fact Respondent could not have defined a single reason why Patient M.R. was reacting the way he did. Finally, the operative note from the November 29, 2000, procedure was appropriate, as it also honestly and accurately depicted what had occurred; he made a specific comment on Respondent's note that the sliver was not indeed from the lumen, but that the exact location was unclear, finding this to be an unambiguous statement of fact. Dr. Kerstein also disagreed with the state's position with regard to the responsibility for maintaining possession of the piece of tubing post-operatively. Dr. Kerstein testified that it was the responsibility of the circulating nurse, an employee of the hospital, to arrange for the piece of tubing to be sent to the pathology lab for examination. The evidence is insufficient to support Petitioner's contention that the pediatric feeding tube sliver at issue caused Patient M.R. to suffer a stroke because of its location within the carotid artery itself. Radiographic studies were performed on Patient M.R. after the stroke. A CT Scan performed on November 28, 2000, revealed an acute right posterior cerebral artery distribution infarct. Further, a cerebral angiogram was performed on November 28, 2000, and revealed "markedly diseased circulation particularly in the right vertebral and basilar arteries." This note also revealed: "Severely diseased posterior fossa circulation." Based upon the location of the infarct in Patient M.R.'s brain, the cause of the stroke had to have been either the vertebral or basilar arteries that supply blood to the posterior part of the brain. In view of all the evidence, the expert testimony of Dr. Kerstein, together with that of Dr. Horowitz, was more persuasive than that of Dr. Dennis in regard to the standard of care and Respondent's actions in this matter.
Recommendation Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated either Subsections 458.331(t) or (m), Florida Statutes, in his treatment of Patient M.R. and that the Administrative Complaint be dismissed. DONE AND ENTERED this 9th day of June, 2003, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2003. COPIES FURNISHED: Michael D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. 390 North Orange Avenue Suite 1000 Orlando, Florida 32802 Daniel Lake, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Conclusions Sovereign immunity extends to “corporations primarily acting as instrumentalities . . . of the state, county, or municipalities.” See § 68.28(2), F.S.; Pagan v. Sarasota County Public Hospital Board, 884 So.2d 257 (Fla. 2d DCA 2004). MRHS was deemed to be an instrumentality of the hospital district by the Attorney General in an opinion dated December 8, 2006 and the circuit court in Marion County has reached the same conclusion in several cases. As a result, MRHS is entitled to sovereign immunity under § 768.28, F.S. The public policy basis for extending sovereign immunity to private entities such as MRHS has recently been questioned by two appellate courts. See University of Florida Board of Trustees v. Morris, 32 Fla. L. Weekly D1803 (Fla 2d DCA July 27, 2007) (Altenbernd, J., concurring), rev. denied, 2008 Fla LEXIS (Fla. Jan. 7, 2008); Andrews v. Shands at Lakeshore, Inc., 33 Fla. L. Weekly D30 (Fla 1st DCA Dec. 20, 2007). The nurses are employees of MRHS and they were acting within the scope of their employment when providing services to Tyler. As a result, the nurses’ negligence is attributable to MRHS. The nurses had a duty to provide competent medical care to Tyler. They breached this duty and violated the standards of care for nursing personnel by failing to report the cyanotic episodes to Dr. Pierre and by failing to properly perform the four-extremity blood pressure test. The nurses’ actions and inactions contributed to the delayed diagnosis of Tyler’s heart condition. However, Dr. Pierre’s failure to order an immediate cardiology consultation when she detected a heart murmur shortly after Tyler’s birth also contributed to the delayed diagnosis of Tyler’s heart condition. The delayed diagnosis of Tyler’s heart condition led to his “crash” on December 16 because it is more likely than not that Tyler would have been transferred to Shands or another tertiary facility had his condition been diagnosed sooner. Tyler was not a candidate for the second and third stages of the Norwood procedure because of the damage caused by the “crash,” and he also suffered brain damage during the “crash” that caused his developmental delay. The amount of damages agreed to by MRHS is reasonable, even though Dr. Pierre likely shares some of the responsibility for Tyler’s condition. Indeed, the life care plan prepared for Tyler reflects that the cost of a transplant is between $650,000 and $700,000 and Tyler is expected to require multiple transplants over the course of his life. Moreover, the non-economic damages (e.g., pain and suffering) of Tyler and his parents could very well have exceeded the settlement amount had the case gone to jury trial. LEGISLATIVE HISTORY: This is the first year that this claim has been presented to the Legislature. ATTORNEYS’ FEES AND LOBBYIST’S FEES: The claimants’ attorney provided an affidavit stating that that attorney’s fees will be capped at 25 percent of the amount awarded by the claim bill in accordance with §768.28(8), F.S. Lobbyist’s fees are not included in the 25 percent attorney’s fees. Lobbyist’s fees will be an additional 4 percent of the amount awarded by the claim bill, which would be $28,000 based upon the $700,000 claim. The Legislature is free to limit the fees and costs paid in connection with a claim bill as it sees fit. See Gamble v. Wells, 450 So. 2d 850 (Fla. 1984). The bill does so by stating that “[t]he total amount paid for attorney’s fees, lobbying fees, costs and other similar expenses relating to this claim may not exceed 25 percent of the amount awarded [by the bill].” If this language remains in the bill (and the bill is amended as recommended below to reflect the allocation approved by the circuit court), the claimants will receive a total of $525,000, with $393,750 going into Tyler’s special needs trust and $131,250 going to his parents. The remaining $175,000 will go to attorney’s fees, costs, and lobbyist’s fees. If this language was not in the bill (and the bill is amended as recommended below to reflect the allocation approved by the circuit court), the claimants would receive approximately $362,000, with approximately $271,500 going into Tyler’s special needs trust and approximately $90,500 going to his parents. The claimants’ attorney would receive a total of approximately $310,000 ($175,000 for attorney’s fees and approximately $135,000 for costs), and the lobbyist would receive $28,000. OTHER ISSUES: The bill identifies the Marion County Hospital District as the entity responsible for payment of the claim. The parties agree, and I recommend that the bill be amended to reflect MRHS as the entity responsible for payment because it is responsible for operating the hospital pursuant to a lease from the hospital district. The bill requires the entire claim to be paid into Tyler’s special needs trust. The parties agree, and I recommend that the bill be amended to require payment of the claim in accordance with the allocation approved by the circuit court, i.e., 75 percent into Tyler’s special needs trust and 25 percent to his parents. The bill requires any funds remaining in Tyler’s special needs trust upon his death to revert to the General Revenue Fund. The parties agree, and I recommend that the bill be amended to remove this language because the bill is being paid from the hospital’s funds, not State funds. The bill should be also amended to include the standard language requiring payment of Medicaid liens prior to disbursing any funds to the claimants. See § 409.910, F.S. RECOMMENDATIONS: For the reasons set forth above, I recommend that Senate Bill 68 (2008) be reported FAVORABLY, as amended. Respectfully submitted, cc: Senator Charlie Dean Representative Marcelo Llorente Faye Blanton, Secretary of the Senate T. Kent Wetherell Senate Special Master House Committee on Constitution and Civil Law Tony DePalma, House Special Master Counsel of Record
The Issue Whether Respondent Cleveland Clinic Florida Hospital's Motion to Dismiss the Petition in this case, for lack of standing, should be granted.
Findings Of Fact The facts necessary for disposition of the Motion to Dismiss are not in dispute. The Public Health Trust of Miami-Dade County operates Jackson Memorial Hospital ("JMH") in Dade County (AHCA District 11). In its Petition for Formal Administrative Hearing, certified to have been served on August 19, 1998, the Trust alleged that JMH is the only provider of adult kidney transplantation services within Florida Transplant Service Planning Area 4, which includes AHCA Districts 8, 9, 10 and 11. The Trust described itself in both the Petition and an amended Petition which followed as: [A]n agency and instrumentality of Miami-Dade County, which is organized and operated pursuant to Chapter 154, Part II, Florida Statutes, and Chapter 25A of the Code of Miami-Dade County. It governs and operates Jackson Memorial Hospital and other designated health care facilities. Its address is 1611 N.W. 12th Avenue, Miami, Florida 33136. Amended Petition, paragraph 2, p. 2. The Trust and Jackson Memorial Hospital are both in Dade County, AHCA District 11. With regard to CCFH, the Petition alleged the following. CCFH is located in Fort Lauderdale, Broward County (AHCA District 10). CCFH has CON approval to construct a new facility in Weston, also in Broward County. It submitted an application for an adult kidney transplantation program at the new Broward County facility which was awarded preliminary CON approval as noticed in the Florida Administrative Weekly on July 31, 1998. It is the application for the adult kidney transplantation program at the Weston facility in AHCA District 10 which the petition seeks to have denied contrary to AHCA's preliminary approval. The Petition's allegations with regard to standing are contained in paragraphs seven and eight: As the sole provider of adult transplantation services in Transplant Area 4, Petitioner has standing to file this petition because its substantial interests will be directly affected by the Agency action for which this petition seeks review. The adverse affects to the PHT if the preliminary approval of CON No. 9026 is upheld include but are not limited to: A decrease in the number of procedures performed at JMH, which may impair research objectives and medical proficiency; A loss of needed revenue to JMH, the largest provider of indigent hospital care in Florida; An increase in the competition for professional staffing, thereby driving up the costs of performing these hospital services; and An increase in the cost to the health care system for performing transplant services through he unnecessary duplication of services. Petition for Formal Administrative Hearing, p. 3 and 4. CCFH moved to dismiss the Petition on the basis that the Trust had not alleged facts sufficient to meet the standing requirement in CON proceedings found in Section 408.039(5), Florida Statutes. In essence, CCFH asserted that the Trust had failed to allege that its adult kidney transplantation program in District 11 was within the same district as the challenged kidney transplant program of CCFH approved by AHCA for District 10. In response, the Trust informed the Agency that it had on the same date filed an Amended Petition which, differs substantively from the original petition only in paragraphs 4 and 8, concerning the issue of standing. By filing its Amended Petition, the Trust adds an additional basis for standing, and does not in any manner retreat from the basis for standing asserted in its original Petition. Public Health Trust's Response to Cleveland Clinic Florida Hospital's Motion to Dismiss, p. 2, paragraph 2. The new paragraphs four and eight in the Amended Petition, state: PHT's medical staff (including its transplantation physicians) is provided by the university of Miami School of Medicine, doing business as the University of Miami Medical Group (UMMG), under an affiliation agreement between the PHT and the University of Miami. Through the UMMG, JMH conducts various activities in Broward County as part of its adult kidney transplantation program, including but not limited to the following: UMMG sees approximately one third of all its post transplant patients at two satellite clinics in Fort Lauderdale; and UMMG through the University of Miami's Organ Procurement Organization maintains agreements with various Broward donor hospitals and provides in-service training to hospital personnel involved in organ procurement, including kidney procurement. * * * As the sole provider of adult transplantation services in Transplant Area 4, as an existing health care facility with an established adult kidney transplant program operating in both Districts 10 and 11, Petitioner has standing to file this petition because its substantial interests will be directly affected by the Agency action for which this petition seeks review. Amended Petition, pages 2 and 3. The Amended Petition was filed with the Department Clerk for AHCA on September 4, 1998, prior to the case's referral by AHCA to DOAH. Argument on the Motion to Dismiss was heard on September 28, 1998. Ruling was reserved until entry of this order.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that the Agency for Health Care Administration enter a final order dismissing the amended petition in this case of the Public Health Trust of Miami-Dade County, Florida. DONE AND ENTERED this 14th day of October, 1998, in Tallahassee, Leon County, Florida. DAVID M. MALONEY 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 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1998. COPIES FURNISHED: Jack P. Hartog, Esquire Assistant County Attorney Jackson Memorial Hospital West Wing 109 1611 Northwest 12th Avenue Miami, Florida 33136 Robert A. Weiss, Esquire Karen A. Putnal, Esquire Parker, Hudson, Rainer & Dobbs LLP 118 North Gadsden Street, 2nd Floor Tallahassee, Florida 32301 Richard A. Patterson, Esquire Agency for Health Care Administration 2727 Mahan Drive, Building 3 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3 Suite 3431 Tallahassee, Florida 32308
The Issue The issue to be resolved in this proceeding concerns whether the Respondent's medical licensure should be subjected to discipline for the reasons asserted in the Administrative Complaint, involving his alleged malpractice concerning patient, E.L.
Findings Of Fact The Respondent at all times material hereto has been a licensed physician in the State of Florida, having been issued License No. ME0030859. The Respondent practices at 1800 N.E. Street, Suite 521, Pensacola, Florida 32501. The Petitioner is an agency of the State of Florida. It is charged by the Legislature, as pertinent hereto, with enforcing the provisions of Chapter 458, Florida Statutes, and related rules, pertaining to the regulation of licensure and the quality of practice of medical doctors within the State of Florida. The Respondent is a board-certified dermatologist, practicing that specialty in the State of Florida in excess of 15 years. There is no evidence of any prior disciplinary action against the Respondent's licensure nor of any prior instance when his practice failed to conform to appropriate professional standards. In the course of his practice, the Respondent sometimes does his own microscopic pathological examination of tissue samples taken from patients (biopsies) on occasions when he deems it appropriate and that a consulting opinion is not required. It is undisputed by the parties that a dermatologist such as the Respondent, who had extensive training in dermatopathology during his medical education, can appropriately do such biopsy work within the standard of care of a reasonable physician practicing under similar conditions and circumstances. If he does so, however, he is held to the standard of a dermatopathologist in the course of his professional practice. The Respondent treated E.L. (an 80-year-old male patient at times pertinent hereto) since approximately 1982 for various problems involving pathology of the skin, including skin carcinoma. On November 21, 1991, E.L. presented as a patient of the Respondent showing a crusty area measuring approximately 1 x 2 centimeters on the vertex of his scalp or the back of his head. The lesion in question appeared on the skin with a hard crust, whitish or yellowish in color, and the Respondent diagnosed it as hypertrophic actinic keratosis. This is sometimes a pre-cancerous condition of the skin. Upon making his diagnosis, which he did clinically, without biopsy, the Respondent performed a curettage, or scraping of the tissue, to remove and destroy it. He did this by injecting the area with lidocaine as an anesthetic before performing the curettage. The Respondent had previously treated the same sort of condition on E.L. with liquid nitrogen but chose, this time, to treat the lesion with extension cautery and curettage. He did this because he was attempting to lessen the discomfort in his 80-year-old patient, who had already undergone a number of procedures to remove pre-cancerous or cancerous lesions of the skin on his head. The use of liquid nitrogen and the associated burning of the tissues involved would cause more difficult healing and discomfort for the patient. The treatment which the Respondent accorded the actinic keratosis condition, by curettage, is an acceptable, appropriate treatment for such a condition. It is undisputed by either the Petitioner's or the Respondent's expert witnesses, as well as the Respondent in his testimony, that such a clinical diagnosis and the following treatment by curettage is within the professional standard of care and practice by dermatologists practicing under similar conditions and circumstances. A biopsy is not a necessary prerequisite to such treatment. After the November 21, 1991 destruction of the skin lesion, the patient did not return for approximately one month. On December 19, 1991, he returned to the Respondent concerned about possible infection at the removal site. The Respondent, however, detected only granulation tissue, which are normal granular projections on the surface of a normally-healing wound. Consequently, there was no reason within the bounds of reasonable medical treatment standards for the Respondent to have biopsied the lesion area on that office visit occasion, either. Patient E.L. returned on January 3, 1992, at which point the Respondent noted a minor area of "dermatitis" or a non-cancerous inflammation of the skin, for which he prescribed a cortisone ointment. The Respondent did no biopsy at that time, either, and the clear and convincing evidence does not demonstrate that a biopsy was required under those conditions and circumstances within acceptable, reasonable bounds of the Respondent's professional practice. Patient E.L. returned to the Respondent on January 23, 1992 complaining of unsatisfactory progress with the healing of the lesion. The lesion by that time had become a rounded, raised growth with central cratering, characteristic of a keratoacanthoma. The Respondent examined the lesion or tumor clinically and determined that it appeared to be a keratoacanthoma. A keratoacanthoma is a rapidly-growing nodule with a central "crater", which then fills with a crusty material. It usually remains localized and most often resolves itself spontaneously, even if untreated. On very rare occasions does it become an aggressively-growing tumor. The Respondent biopsied the suspected keratoacanthoma by performing an excision of the area. He excised the nodule, taking a narrow margin of several millimeters around it and then performed a suture closure of the wound. He performed a biopsy of the tissue thus taken himself and interpreted the biopsy results approximately one week later as confirming his clinical diagnosis of a keratoacanthoma. Keratoacanthoma is regarded as a "low-grade" form of squamous cell carcinoma. The diagnosis is based upon a clinical observation with the naked eye, based upon history, as well as by pathological diagnosis. Conservative treatment is appropriate for a keratoacanthoma since they often resolve themselves spontaneously. Simple observation, surgical excision, curettage with or without electro-desiccation, radiation therapy, intra-lesional injection, and topical application of 5-fluorouracil and methotrexate are all acceptable forms of treatment for keratoacanthoma and can be reasonably expected to cure the condition. On rare occasions, keratoacanthoma can recur, even with such treatment. The diagnosis and treatment of keratoacanthoma is a matter of good- faith differences of opinion among reasonable dermatologists and pathologists, based upon their clinical judgment and experience. Some diagnose it as keratoacanthoma, which is a low-grade form of squamous cell carcinoma; and some diagnose it as squamous cell carcinoma with varying degrees of "differentiation". The photograph of the lesion as it was seen by the Respondent prior to the January 23, 1992 surgery shows a lesion consistent with the clinical appearance of a keratoacanthoma. The Respondent has been properly trained as a dermatologist in dermatopathology, and he commonly reviews biopsy and pathology slides. He is not required, under pertinent practice standards, to seek consultation when he believes that he has made a proper diagnosis. It was proper for him to read and review the pathology slide of the biopsy specimen, even though he himself acknowledges, as do the two expert witnesses, that he would be held to a dermatopathologist's professional practice standard by doing so. The Respondent opined that actinic keratosis developed into the keratoacanthoma. Dr. Breza, the Petitioner's expert witness, opined that actinic keratosis does not develop into keratoacanthoma but, rather, into squamous cell carcinoma. Even he acknowledged, however, that good pathologists have trouble making the diagnosis of keratoacanthoma and prefer generally to diagnosis such conditions as simply "low-grade" squamous cell carcinoma. Dr. Hanke, in his testimony, established that keratoacanthoma and squamous cell carcinoma are different gradients of diagnosis on the same continuum or range describing squamous cell carcinoma. That is, in lay terms, a keratoacanthoma is a "low-grade" squamous cell carcinoma. They are not precisely the same diagnosis, but both diagnoses describe the same general type of cells. As shown by Dr. Breza, squamous cell carcinoma tumors or lesions generally tend to appear somewhat flatter than that characteristic of a keratoacanthoma. Squamous cell carcinomas tend to be more indurated or firm on the outer edges and to have more inflammation on the outer edges, including occasional ulceration. The Respondent's description in E.L.'s medical record seems more consistent with squamous cell carcinoma, but the photographic images of the growth or lesion at issue, made at the time the biopsy and excision was performed, appear also consistent with keratoacanthoma. Based upon the information, including clinical appearance, that the Respondent had to consider in making his diagnosis and given that reasonable pathologists can differ concerning the gradients of diagnosis of squamous cell carcinoma (which includes keratoacanthoma), as shown by the expert testimony, the Respondent's diagnosis does not constitute a departure from appropriate, professional standards. The deficiency in the Respondent's practice in this instance began with the excision made on January 23, 1992. The Respondent took the tissue material from the excision for biopsy and, after pathological examination of the sample, diagnosed the nodule as keratoacanthoma. The Respondent, however, did not establish a "negative margin" for the excision. That is, the tissue removed had positive margins, especially the deep margin, which means that carcinoma cells could be observed on the surface of the piece of tissue removed. This means that the Respondent could not be assured that carcinoma cells did not remain in the tissue area surrounding the walls of the excision site because the margin of the excision around the nodule to be removed was not wide enough. The same slide and tissue sample which the Respondent used for biopsy in January 1992 was examined by a dermatopathologist, but not until some six months later, in July 1992. The dermatopathologist reported his opinion that the biopsy showed an "infiltrating squamous cell carcinoma with involvement of the lateral and deep margins." An infiltrating carcinoma implies that it is a more aggressive tumor than would be the case with a normal keratoacanthoma. The Respondent did not report those positive margins from the results of his excision and biopsy in January 1992. His testimony indicates that he may have seen them or been aware of them but did not make a larger incision in order to achieve a negative margin because of his concern about the complicated closure techniques that would be necessary. He was concerned with attendant additional discomfort to this elderly patient, as might be entailed with the possible use of grafting in order to make closure of the wound. He also seemed to discount the need to excise a larger margin because of his belief that he was dealing with a non-aggressive keratoacanthoma. In fact, however, the clear and convincing evidence shows that a larger margin wound could have been excised without the necessity for more elaborate techniques of closure and attendant discomfort to the patient. Moreover, it was established that even this elderly patient, with his attendant heart problems, could have tolerated a more elaborate excision of the tumor in question, since the procedure could still be done under low-risk local anesthesia in the Respondent's office. An infiltrating carcinoma is one which is more aggressive. It can move from its original location and infiltrate the skin and blood vessels, which can, in some cases, result in the tumor spreading via the blood stream or by infiltrating the lymphatic system, with migration to regional lymph nodes. The squamous cell carcinoma is not known for being a readily metastasizing form of cancer. It is known on some occasions to metastasize, however. The finding of positive margins on the pathological examination in July 1992 means that the tumor extended to the cut surface of the excision at the time of the January excision procedure from which that biopsy sample was taken. Thus, tumor cells remained in the patient's scalp after the January 1992 excision procedure. The finding of a positive margin requires that another margin be established, meaning that the physician must cut another level of tissue until normal skin (a negative margin) is revealed. This can be done by conventional surgery, by just a larger excision area being removed, or by "MOHS" surgery, which involves freezing sections of the excision area, with small portions of the suspicious area removed at a time and with attendant pathology examinations so that each "thread" of cancer cells can be removed with minimal damage to surrounding tissues and less attendant discomfort and healing problems associated with the resulting surgical wound. The patient could have tolerated either type of procedure in January 1992. The Respondent did not establish a negative margin, however. He only excised the carcinoma once. He stated that he was really seeking only a biopsy sample and that he considered the treatment by excision of the nodule itself and attendant scraping of the wound to be adequate as conservative treatment, to take care of what he believed to be a non-aggressive keratoacanthoma. This may be a correct assessment if the physician is certain that he is confronted with a non-aggressive, non-infiltrating keratoacanthoma. However, if positive margins to the excisional wound result, the patient is better served, and a successful treatment result much more likely, if all suspected carcinoma cells are removed at that time. If the Respondent knew of the positive margins to the excision and had made an additional excision to remove all positive margins, the provision of additional, more elaborate treatment techniques would not have been delayed for nearly six months and likely would have been unnecessary. The determination of the existence of positive margins, after the January 1992 excision procedure, should have caused him to remove additional tissue to obtain a safe, negative margin. That failure of care, in his capacity as a dermatopathologist, resulted in a six-month delay before the dermatopathologist, at Sacred Heart Hospital, identified the positive margins. He identified them on the Respondent's same January 1992 pathological slide, when he examined it in July 1992, after which radiation and further more radical treatment was attempted. Thus, the delay in treatment action, resulting from the delay in acting on the existence of positive margins by the Respondent, resulted in a six-month delay in appropriate treatment being provided the patient, which is a deviation from the accepted standard of care, as established by the testimony of Dr. Breza, which is accepted in this regard. Earlier determination (or acting on a determination) of the positive margins, after the January 1992 excision procedure would have alerted the Respondent that the excision procedure was unsuccessful and that further treatment was necessary. The patient's lesion occurred on a sun-damaged scalp. The Respondent had treated the patient repeatedly for sun-damaged skin problems, including carcinomas, in the past. Squamous cell carcinomas can be susceptible to mestastases, either regional or systemic when they are located on the scalp, although they are much less susceptible to such mestastases than if they are located on the lip or possibly the dorsal surface of the hand. The Respondent, as a board-certified dermatologist, knew or should have known that the scalp is an area of the body that can be susceptible to metastatic disease such as squamous cell carcinoma. The patient, as even acknowledged by the Respondent's expert, Dr. Hanke, was one with a high risk for developing skin cancer. In any event, after the excision procedure on January 23, 1992, the patient was seen on February 10, 1992 for removal of sutures and examination of the wound. It appeared to be healing nicely at the time, and the patient was advised to return to the Respondent in three months, unless a problem developed. The Respondent next saw the patient on April 6, 1992, when he complained of persistent pain at the excision and tumor site. This was treated by the Respondent by drainage, antibiotics, narcotic pain medications, and sleep- inducers. Later during the treatment regimen, in approximately May 1992, the Respondent felt that chemotherapy was indicated because apparently, the lesion had not been completely excised. Consequently, he prescribed injections of intralesional cortisone methotrexate and 5-fluorouracil. These, however, did not produce satisfactory healing or control of the pain. During April and May 1992, the Respondent saw the patient for complaints of persistent pain, poor healing, and drainage of the wound. On May 18, 1992, the Respondent performed a drainage of the lesion which had begun to show an abscess formation. An abscess formation is an indicator of squamous cell carcinoma, which should have been recognized by the Respondent. This should have alerted him that his diagnosis of simply keratoacanthoma was not correct, at least by that time. With the presence of these continuing and exacerbated problems with the wound site, the Respondent did not seek or perform further biopsy of the tumor site, despite continued complaints of persistent pain and further growth of the lesion between April and July 1992. The patient made 16 visits to the Respondent between April 1992 and July 14, 1992 for treatment and pain relief. During this time, little improvement occurred in the patient's condition, but no additional biopsy or consultation was requested or performed by the Respondent. The lack of improvement in E.L.'s condition during the period of April through July 1992 should have alerted the Respondent that something was incorrect about the patient's condition and that more extensive radical treatment would be necessary. In fact, the Respondent did respond to the continued complaints by, in addition to prescribing antibiotics and pain medication, prescribing the above- referenced intralesional injections of cortisone, methotrexate, and 5- fluorouracil. On July 9, 1992, another curettage procedure was performed and the pathology of the scrapings was sent for evaluation by a pathologist. The Respondent's interpretation of this tissue at the time apparently was a keratoacanthoma; well-differentiated squamous cell carcinoma. This was ultimately described by the pathologist to whom it was referred as a moderately- differentiated squamous cell carcinoma. Subsequently, after the C&D procedure, the patient was referred to Baptist Hospital in Pensacola, Florida, for radiation therapy. He received a full-course of radiation therapy with some booster therapy afterward and then, on his own volition, went for a second opinion to the University of South Alabama Medical Center in Mobile, Alabama. Five physicians at that facility recommended more extensive surgery, which ultimately the patient refused. There is no clear and convincing evidence that, at least at that point in the patient's progress, the persistent tumor had actually mestastized, although it was apparently growing locally. The fact that the lesion at issue was failing to heal and producing persistent pain by the visit of April 6, 1992 should have been interpreted so as to set in motion further investigative procedures, including an additional biopsy, to find out the reason for that condition and its persistence. Although a proper procedure involving excision and biopsy was done in January of 1992, the frozen sections of the lesion could have been interpreted to show that the tumor was an infiltrating carcinoma extending to the lateral and deep margins of the excision and something more aggressive could have been done to treat it at that time. It could have either been re-excised with frozen section control of the margins, referred to a "MOHS'" surgeon for a similar type of surgery or referred to a general surgeon. Radiation therapy could have been tried, at least by the time the persistence of the problem was determinable in April of 1992. The resultant reduction of delay in securing more extensive treatment of the lesion would have certainly benefited the patient. The persistence of the pain in the six-month period of time after the January 1992 excision of the tumor, until just before the time the patient was referred for radiation therapy indicates there was probably perineural invasion by the tumor (infiltration of the nerves), which produced pain. This should have alerted the Respondent that something more than a non-aggressive keratoacanthoma was involved, as well. In summary, it has been demonstrated that the Respondent failed to practice medicine within that level of care, skill and treatment recognized by reasonably prudent, similarly-situated physicians as acceptable under the circumstances, by failing to make an additional biopsy after the patient re- presented with problems associated with persistent pain and improper healing in April 1992; by failing to recognize and act on the presence of positive margins to the excision material taken in January 1992, to effect an additional excision at that time, so as to secure a safe, negative margin to the tumor. The failure to obtain consultation on the biopsy taken from a dermatopathologist was not in itself evidence of falling below appropriate professional levels of care, skill and treatment, but the Respondent, by doing his own interpretation of the biopsies was, as he agrees, creating a situation in which he would be held to the same standard as a dermatopathologist. The failure to correctly interpret the biopsy he took in January 1992, by failing to recognize the positive margins to the excised material and failing to act to remove those indicia of the continued presence of the tumor, at a time when it was thus easily excised, likely prevented an easily-effected cure.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found guilty of a violation of Section 458.331(1)(t), Florida Statutes, in the manner concluded above, and that the Respondent receive a private reprimand, a $2,000.00 fine, and that he be required to attend 20 additional hours of Category I continuing medical education in the area of diagnosis and treatment of skin cancer. DONE AND ENTERED this 30th day of October, 1995, in Tallahassee, Florida. P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3531 Petitioner's Proposed Findings of Fact 1-8. Accepted. 9-10. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not itself materially dispositive. Rejected, as contrary to the clear and convincing evidence. The evidence does not reflect that one biopsy sample only showed one part of the lesion at issue but, rather, several parts were represented. Accepted. Accepted, but not itself materially dispositive. 15-21. Accepted. 22-24. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 25-26. Accepted. 27. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 28-36. Accepted. 37-41. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 42-44. Accepted. 45. Rejected, as contrary to the clear and convincing evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 46-53. Accepted, but not in their entirety materially dispositive. 54. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 55-56. Accepted. Rejected, as not in its entirety supported by clear and convincing evidence of record. Accepted. Accepted, to the extent of failing to practice medicine within the appropriate standard of care by not making earlier and more frequent biopsies only. Respondent's Proposed Findings of Fact 1-17. Accepted. 18. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 19-20. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter, and as not entirely in accord with the clear and convincing evidence of record. Accepted. Accepted, but not necessarily as to its material import and subordinate to the Hearing Officer's findings of fact on this subject matter, which contain additional findings of fact not contained in Proposed Finding of Fact No. 23 and which are material, relevant, and necessary to a clear picture of the patient's progress and treatment rendered during the period of April 6, 1992 through July 14, 1992. Accepted, but not as to its purported material import. Rejected, as contrary to the clear and convincing evidence of record, and as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not as to its purported material import. 27-31. Accepted. COPIES FURNISHED: Britt Thomas, Senior Attorney Mary Anne Davies, Certified Legal Extern Agency for Health Care Administration 1940 North Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Donald Partington, Esq. CLARK, PARTINGTON, ET AL. Post Office Box 13010 Pensacola, FL 32591-3010 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, FL 32399-0770 Jerome W. Hoffman, Esq. General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32309
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made: At all time pertinent to this proceeding, Respondent, Jules G. Minkes, was licensed as an osteopathic physician in the State of Florida having been issued license No. OS 001516. There is no evidence that Respondent has ever been the subject of prior disciplinary action by the Petitioner, Department of Professional Regulation, and/or the Board of Osteopathic Medical Examiners. Respondent is certified by the American College of Osteopathic Internists, the American College of Osteopathic Board of Cardiology, the American Osteopathic Board of Nuclear Medicine and the American Board of Nuclear Medicine. Respondent has no advanced or specialized training in dermatology, however, he did complete courses in dermatology as a student and, as part of his primary care practice, he does provide some minor dermatological treatments. At all pertinent times, Respondent was the medical director of South Dade Osteopathic Medical Center d/b/a Suburban Medical Center ("Suburban"). Suburban was a primary care provider facility with International Medical Center ("IMC"), a health maintenance organization ("HMO"). Suburban contracted to become part of the IMC HMO system beginning in June of 1981. Under the IMC system, a patient's primary care physician was the "gatekeeper" four medical services. In the absence of an emergency, a patient was required to first see his primary care physician in order to be referred to other specialized medical care. Conflicting evidence was presented regarding the operation of the IMC program and the procedures for referring patients to specialized medical care and/or physicians who were not part of the HMO network. The IMC referral procedures and the manner of allocating the costs of specialized treatment were not the same at all IMC facilities and were changed several times during the early and mid 1980's. (Certain pertinent aspects of the referral process are explored in more detail in Findings of Fact 37 below.) IMC developed a network of physicians to whom primary care physicians could refer patients for specialized medical treatment. In accordance with its IMC contract, Suburban was expected to provide all primary medical care for all IMC patients assigned to the center. Respondent and Suburban agreed to refer IMC patients to specialists, hospitals, etc. within the IMC network "unless approval for a nonparticipating facility or a professional is specifically approved by the medical director or executive director of IMC." At all times pertinent to this proceeding, Respondent referred his HMO patients to the IMC specialist network with the expectation that those specialists would either treat the patient or further refer them as necessary. Some IMC affiliated providers entered into "risk" contracts with IMC and were responsible for paying specialists and/or directly negotiating arrangements for those specialists to be compensated. The evidence established that, during the time that the Patient was treated at Suburban, Suburban did not have a "risk" contract with IMC. As set forth on page 4 paragraph 23 of the contract between Suburban and IMC (Respondent's Exhibit 3) IMC paid the specialists attending to Suburban's HMO Medicare patients. In accordance with Suburban's contract, IMC allocated a specific amount per member per month to be deposited into an account and applied towards payments of the specialists. At the end of each quarter of the calendar year, IMC was supposed to distribute any sums remaining in the specialists' account to Respondent. However, during the time the contract was in effect, there were never any funds remaining in the specialists' account at the end of any calendar quarter. Therefore, no funds from this account were ever distributed to Respondent. IMC developed a plan for treating Medicare eligible patients. This program was known as the Gold Plus Plan and required the patient to essentially assign their Medicare benefits to the HMO. All patients who enrolled in the Gold Plus Plan executed an agreement acknowledging that all non-emergency medical treatment had to be provided or arranged for by IMC and that they would be limited to seeing doctors within the IMC network. All patients were advised that they could see a specialist at their own expense or could disenroll from the HMO at any time and return to their prior Medicare status. The Patient, T.G., enrolled in the IMC Gold Plus Plan in July of 1982 and executed the standard agreement. At the time she was first seen at Suburban, T.G. was approximately 68 years old. She was a somewhat difficult patient who frequently complained of numerous minor ailments. In approximately 1978, while she was living in New York, T.G. had a basal cell carcinoma removed from her forehead by a dermatologist. T.G. and her husband, C.G., moved to Florida in approximately 1978. Shortly thereafter, additional lesions appeared on her forehead. The Patient's family physician at the time, Dr. Kenneth Hertz, referred T.G. to a dermatologist, Dr. Darrell Blinski, who biopsied the lesions in August of 1981. The pathology report from the biopsy contained a diagnosis of "basal cell carcinoma; both side margins are involved. The deep margin is clear." Involvement of the surgical margins of a biopsy indicates the basal cell carcinoma has spread to the limits of the biopsy and perhaps beyond. On August 22, 1981, T.G. was admitted to coral Reef General Hospital where Dr. Blinski attempted to excise the basal cell carcinoma and performed a Limberg flap procedure to cover the skin defect on her forehead. As a result of the procedure, the Patient had a noticeable scar in the middle of her forehead. Dr. Blinski's admission notes in connection with this August 22, 1981 procedure indicate T.G. had: ... a history of multiple recurrences of basal cell carcinoma of the forehead under treatment in New Jersey and down here... incisional biopsy of a central forehead lesion was done and returned as a basal cell carcinoma, margins involved. The area in question wad in the central forehead. The physical examination revealed an ulcerated lesion measuring 2 mm x 5 mm in the central forehead with a scarred area to the left of that measuring 4 mm in diameter. Involved skin is within 1 cm. Examination of the rest of the facial skin was negative for lesions. A pathology report dated August 27, 1981 on tissue removed during the procedure performed by Dr. Blinski revealed basal cell carcinoma with the "left lateral margin free of tumor, all others surgical margins involved with tumor." In other words, not all of the tumor was removed during the surgery by Dr. Blinski. Dr. Blinski referred the Patient to Dr. Henry Menn for consultation. Dr. Menn was a professor of dermatology and head of the Mohs chemosurgery unit at the University of Miami. In a letter dated September 21, 1981, Dr. Menn advised Dr. Blinski that he thought: It would be best to initiate Mohs Chemosurgery excision of the residual basal cell carcinoma discovered by you in the surgical margins of your excised specimen performed on 27th of August, 1981, from tissue removed from the forehead. In approximately four weeks inflammation and irritation normally present after a surgical flap procedure will be reduced and the chemosurgical excision will be more easily accomplished. Dr. Menn apparently changed his treatment plan for the Patient because, instead of undertaking chemosurgery, he simply followed the patient clinically until the summer of 1982. During that time period, there were no clinical signs of regrowth of the basal cell carcinoma. While primary basal cell carcinoma typically grows in little mounds of cells, recurrent basal cell carcinoma can grow in a different, infiltrative fashion. This type of growth tends to be more subtle and the skin can appear normal for extensive periods of time. T.G. returned to Dr. Menn on December 17, 1981 and, in a letter dated December 21, 1981, Dr. Menn advised Dr. Blinski that: ... about four months have now passed since you excised the large basal cell carcinoma on her forehead. There is no clinical evidence of regrowth of tumor even though the surgical excision margins were involved by tumor after your treatment. Close clinical inspection and palpation do not reveal the evidence of basal cell carcinoma at this time... I will continue to follow the patient at periodic intervals. If there is any evidence of malignancy, I will do an excisional biopsy and initiate chemosurgical treatment as indicated. On March 15, 1982, Dr. Blinski examined the patient and advised Dr. Menn by letter that "there is no recurrence as of this time. She will be followed in four months." By letter dated May 19, 1982, Dr. Menn advised Dr. Blinski "I re- examined our patient [T.G.] on the 18th of May, 1982. I am pleased to report that there is no evidence of regrowth of the skin cancer were [sic] you performed plastic surgery on her forehead... I will continue to follow the patient." On July 22, 1982, T.G. and her husband joined the IMC Gold Plus Plan. Because the Gold Plus Plan required the enrollees to assign their Medicare benefits, T.G. stopped seeing Dr. Menn at this time. T.G. had an appointment with Dr. Menn on October 7, 1982. Dr. Menn's notes indicate that the patient did not appear for her appointment and there is a notation that the "patient wishes to continue care in her HMO." Suburban was the HMO affiliate center to which T.G. was assigned. T.G.'s first visit to Suburban took place on September 3, 1982. During that visit, T.G. advised the Respondent that she had a history of skin cancer. During the physical examination of the Patient, the Respondent noted the scar on her mid-forehead. At the time of the Patient's initial visit to Suburban, the medical records of her prior treatment by Dr. Blinski and Dr. Menn were not available. At some point, those records were obtained by the Respondent. However, it is not clear when the records were received. T.G.'s second visit to Suburban was on September 17, 1982. There is no indication in the medical records of that visit that her forehead was examined. On October 4, 1982, T.G. returned to Suburban and complained to Respondent that her "forehead always feels hot." The Respondent noted a "small left papular swelling 4mm at lower portion of scar-subcut." Under the "assessment" portion of his medical form, Respondent wrote "(1) follow possible recurrence basal cell carcinoma-left lower forehead (2) 1-2mm lesion on right forehead (3) keratotic lesion-right arm." During the October 4, 1982 visit, Respondent hyfercated the lesions on the Patient's right forehead and right arm. Hyfercation is an electrocauterization that burns or desiccates skin lesions by removing the water content of skin cells. Hyfercation destroys tissues and, as a result, the tissue cannot be pathologically diagnosed unless a biopsy is first taken. No biopsy was taken prior to the hyfercation of either of the lesions. Although Respondent has no specialized training in dermatology, he regularly hyfercates skin lesions as part of his office practice. Respondent believes that he has the ability to differentiate between minor, obviously benign skin lesions and those that are more questionable and should be referred to a dermatologist. Respondent noted on the medical records from this visit to "follow for excisional biopsy." That comment was made with respect to the lesion on the Patient's lower left forehead. That lesion was not hyfercated. Instead, the Respondent decided to refer the Patient to a dermatologist in the IMC system for the treatment of that lesion. On October 14, 1982, the Respondent signed the referral form for T.G. to go to the IMC Dermatology Center at a facility known as the Westchester Clinic. An appointment with the IMC dermatologist was scheduled for October 21, 1982. On that day, the Patient was seen by Dr. Seymour Munzer, a dermatologist affiliated with IMC. The exact nature of Dr. Munzer's business relationship with IMC was not established, but he apparently traveled to various IMC Centers to treat patients. During the October 21, 1982 visit, Dr. Munzer noted the Patient's history of surgery for basal cell carcinoma with Dr. Blinski. He noted some nodular firmness above the left brow. His diagnostic impression was "(1) prob. [sic] scar tissue (2) r/o [rule out] recurrent basal cell carcinoma." Patient stated on several occasions that she did not like Dr. Munzer and wanted to see Dr. Menn, her options under the Gold Plus Plan were fully explained to her and she was advised that, under that plan, her treatment would have to be coordinated through the IMC dermatologist. She was also advised that she could see Dr. Menn at her own expense or disenroll from the program and continue her care under traditional Medicare procedures. The Respondent never completed any additional dermatological referral forms for the Patient. While Dr. Munzer claims that a written referral from the primary care physician was necessary every time a patient returned to see him, this testimony is rejected. The more creditable evidence established that Respondent was not required under the IMC system to issue a referral for each visit by a Patient to an IMC specialist. Dr. Munzer biopsied the lesion over the Patient's left brow and submitted it for pathological diagnosis. The pathology report was returned on October 26, 1982 and indicated "basal cell carcinoma, infiltrating. Surgical margins involved by the lesions." T.G. returned to Suburban on November 3, 1982. The records of that visit indicate that the Respondent was waiting for the pathology report. For his assessment, Respondent noted "r/o [rule out] basal cell carcinoma forehead." Respondent's plan was to "follow path report Westchester Center." During the November 3 visit, Respondent removed a 1mm keratotic lesion from the Patient's lower right chin. The Patient returned to Suburban on November 23, 1982. By that time, Respondent had received a copy of Dr. Munzer's report and the pathology report on the biopsy performed by Dr. Munzer. The Respondent discussed the results of the biopsy with the Patient and her husband and explained that she needed to follow up with the dermatologist. While the Patient and her husband have testified that the Respondent advised them that he could treat her basal cell carcinoma, this testimony is rejected. The more creditable evidence established that the Respondent advised the Patient of her need for follow-up by a dermatologist. The Respondent discussed the results of the biopsy with Dr. Munzer by phone and it was his understanding that Dr. Munzer would continue to follow the Patient and provide whatever additional treatment was necessary. The Respondent never received any additional reports or correspondence from Dr. Munzer regarding the Patient. Because the IMC specialists rotated between several hospitals, there was often alot of confusion regarding the paperwork for those patients referred to specialists. It was not unusual for there to be significant delays between the time an IMC specialist saw a patient and the time the specialist's report was sent to the primary care physician. In fact, in many instances such reports were never received. Thus, while Respondent did not receive any further reports from Dr. Munzer, Respondent thought Dr. Munzer and/or IMC was providing treatment for the Patient's basal cell carcinoma as diagnosed in the October 26, 1982 pathology report. No records of the treatment rendered by Dr. Munzer could be obtained from either Dr. Munzer or the Westchester Clinic where Dr. Munzer treated the Patient. It is not clear whether the Patient ever returned to Dr. Munzer for further evaluation or treatment. 1/ However, it is clear that Respondent and his office staff advised the Patient on several occasions that she needed to follow-up with the dermatologist. While the There is no evidence that Dr. Munzer ever developed a plan for treating T.G. Dr. Munzer could not specifically recall his treatment of this Patient except to review his report and the pathology report in Respondent's records. Dr. Munzer testified that he would not have attempted to treat a patient with recurrent basal cell carcinoma on the face, particularly in the area of scar tissue. Instead, he states that he would have recommended either Mohs chemosurgery, referral to a plastic surgeon or possibly radiation therapy. However, it does not appear that Dr. Munzer ever communicated his reluctance to treat such a condition to the Respondent. As far as the Respondent knew, Dr. Munzer and/or the IMC Dermatology Center were capable of treating this Patient. While Dr. Munzer claimed that he did not have authority to refer a patient from an affiliate center for further follow-up, at the very least his input and recommendation would have been essential to determine how to treat a patient with unique dermatological problems. In this case, it does not appear that he ever provided such a recommendation or opinion. Moreover, while Dr. Munzer contends that the Medical Director of an affiliate center was the only person who could make referrals outside the IMC network, Suburban's contract with IMC required such determinations to be made by the Medical Director of IMC. The evidence established that, under Suburban's contract, once a patient was referred to an IMC specialist for treatment, that specialist and IMC were responsible for determining whether to send the patient for additional consultation to a physician outside the IMC network. At no point during the treatment of this Patient did the Respondent attempt to treat the Patient's known basal cell carcinoma. The Patient was next seen by the Respondent on December 7, 1982. The Respondent noted "basal cell carcinoma left-forehead." There is no indication that the Respondent was attempting any treatment for this problem. The Patient was instructed to return in three months. The Patient was treated by the Respondent on February 1, 16, and March 7, 1983 for various ailments and complaints. There is no mention of the Patient's basal cell carcinoma in the medical records of these visits. On April 1, 1983, the Respondent excised a skin lesion on T.G.'s left shoulder. The Respondent submitted the excised lesion for biopsy and the pathology report stated that there was no evidence of malignancy. There is no evidence in the medical records of the April 1, 1983 report that Respondent treated or discussed the basal cell carcinoma on the Patient's forehead. The Patient returned to Suburban on April 4, 6, and May 2, 1983. She was seen by the Respondent during the April 4 and May 2, 1983 visits. The records of those three visits do not reflect any treatment or discussion of the Patient's forehead. The Patient's next visit to Suburban was on May 24, 1983. During that visit, Respondent noted a "2mm keratotic skin lesion, mid forehead." That lesion was high on the forehead near the hairline. It was not in the scar area or adjacent to the previously diagnosed basal cell carcinoma. The Patient wanted the lesion removed for cosmetic reasons and it was the Respondent's opinion that the lesion was not clinically related to the Patient's previous problems. The Respondent felt that the appropriate treatment was to obliterate the lesion and watch for any recurrence rather than to biopsy such a small lesion which appeared benign. His assessment was "keratosis, possible basal cell carcinoma." He hyfercated the lesion and noted to follow it for healing. Because no biopsy was done on this lesion, there is no pathology report available to establish whether or not this lesion was a basal cell carcinoma. Some of the expert witnesses in this proceeding have testified that the Respondent's failure to biopsy this lesion falls below the standard of care expected of a reasonably prudent physician under similar circumstances. However, that testimony presupposes that the lesions was contiguous or adjacent to the prior problem areas. Moreover, even Petitioner's experts admit that a primary care physician such as Respondent should be able to recognize and distinguish cosmetic skin problems from more questionable problems that need closer scrutiny. There is insufficient evidence to disregard Respondent's clinical diagnosis. Even though the Patient had a history of basal cell carcinoma, it was possible, indeed it is likely, that a patient with her history would develop unrelated cosmetic lesions. At the time that the lesion was hyfercated, the Respondent once again advised the Patient that she needed to continue seeing the dermatologist regarding the previously diagnosed basal cell carcinoma. Sometime during the Patient's visits in April or May of 1983, Respondent became aware that the Patient had not been returning to Dr. Munzer for follow-up care of the basal cell carcinoma of her forehead. Until this time, the Respondent had assumed that the Patient was being treated by Dr. Munzer. The Patient reiterated her dislike for Dr. Munzer and also indicated that she did not like the Westchester facility. The Respondent once again explained her options under the HMO plan and advised her of the need to seek specialized care for her basal cell carcinoma. The Patient did not exercise any of the options explained to her and continued to be treated at Suburban through at least March of 1984. During that time, she was treated for various ailments, but no attempt was made to treat the basal cell carcinoma. The Patient's next visit to Suburban took place on June 1, 1983. In addition to treating other unrelated complaints, the Respondent noted that the wound from the hyfercated forehead lesion was healing. The Patient was also treated at Suburban on June 16 and 21, July 7 and 25, August 1 and 9 and October 17, 1983. The Respondent saw the Patient on all of those visits except for the June 16, July 25, and October 17 visits when she was treated by other Suburban employees. There is no indication in the medical records of these visits that the Patient's forehead and/or basal cell carcinoma were treated. The Patient did not appear for scheduled appointments on June 6, July 18, and August 12, 1983. During a visit on November 1, 1983, the Respondent noted a lesion on the Patient's right forehead. This lesion was not contiguous to the Patient's scar nor was it adjacent to the area biopsied by Dr. Munzer. The Respondent hyfercated this lesion. As with the other lesions that Respondent hyfercated, the hyfercation was performed for cosmetic reasons and not because of any medical necessity. Each of the lesions that were hyfercated healed quickly and completely without any sign of regrowth. Because the lesions were hyfercated, biopsies were not possible. The absence of a pathology report precludes a conclusion that none of the hyfercated lesions were malignant. However, the Respondent's testimony that he only hyfercated lesions in areas where no previous problems had occurred and that appeared clinically benign is accepted. Therefore, there was no deviation from the standard of care expected of a reasonably prudent physician. The Patient returned to Suburban on November 8, and 28, and December 14, 1983 and January 13 and 30, 1984. There is no indication that the Respondent saw the Patient on those visits. The Patient was seen by other physicians employed by Suburban. None of those physicians attempted to treat any skin problems and/or the forehead area of this Patient. There is no indication that any of these physicians noted any abnormality on the Patient's forehead. During those visits when the Respondent saw the Patient, the Respondent would typically check her forehead to determine if there were any changes in the scar or the area that Dr. Munzer had biopsied. No changes were evident until the Patient's visit on February 6, 1984. During the February 6, 1984 visit, the Respondent noticed a slight nodularity on the Patient's forehead. Respondent did not attempt to treat that bump. He again recommended to the Patient that she see the dermatologist. The only notation in the medical records was "follow slight nodularity-forehead-hx [history] basal cell CA." The Patient was instructed to return in two weeks. The Patient returned to Suburban on February 7, 13, 27, and March 14, 1984. The Respondent only saw the patient on the February 13 visit. During these visits, she was treated for various unrelated matters and there is no notation regarding her basal cell carcinoma or the nodularity noted on February 6. On March 7, 1984, T.G. transferred to Dr. C.N. House's IMC affiliated provider center. On her first visit to Dr. House on April 6, 1984, T.G. was referred to a dermatologist, Dr. Kenneth Rosen, for a biopsy of her forehead. At the time of this visit, Dr. House did not have any of the Patient's prior records. Dr. Rosen took biopsies from three areas of the Patient's forehead: one from the "right forehead", one from the "mid-forehead", and one from the "mid-forehead above left side." The pathology reports on all three sections indicated basal cell carcinoma that had been incompletely excised. The multiple sites of carcinoma indicate that the tumor was infiltrating. Dr. Rosen advised Dr. House that he was not qualified to treat the Patient. He advised Dr. House that the Patient needed to be referred for Mohs chemosurgery. At the time, the only physician in Miami that Dr. House knew could perform that surgery was Dr. Menn. Mohs chemosurgery, now known as Mohs micrographic surgery, is the treatment of choice for recurrent basal cell carcinomas because of its high cure rate and conservation of healthy skin. Dr. House's contract with IMC was a "risk" contract. Under that contract, the fees for treatment by specialists were directly deducted from his payment from IMC. Dr. House arranged his own network of specialists to whom he would refer patients. As indicated above, the Respondent's contractual arrangement with IMC was different and, at least during the time this Patient was being treated, Respondent only referred patients to the network developed by IMC. Dr. House arranged for the Patient to be seen by Dr. Menn on May 15, 1984. In making this arrangement, Dr. House agreed to personally assume responsibility for Dr. Menn's fees. T.G. was treated by Dr. Menn at the University of Miami with the Mohs Chemotherapy technique in four stages over a period of three days, May 29, 30, and June 1, 1984. The Mohs Surgery revealed an extensive basal cell carcinoma that covered most of the Patient's forehead area. Extensive skin was removed during the surgery and, in some areas, the surgery penetrated to the underlying bone. The surgery reports indicate that all of the area was one continuous basal cell carcinoma of the forehead, the eyelids and the nasal dorsum. Dr. Garland believes that the basal cell carcinoma treated by Mohs Chemosurgery in May of 1984 was the same tumor present and growing at the time that Dr. Menn was seeing this Patient in 1981 and 1982. After the Mohs Surgery, the Patient was referred by Dr. House to Dr. Gary Zahler, an IMC Plastic Surgeon, for repair by skin grafting of the extensive wound to her forehead. After the surgery, the Patient was followed by Dr. Menn until his death in 1985. Dr. Larry Garland, a colleague of Dr. Menn at the University of Miami and a dermatologist specializing in Mohs Chemosurgery and cutaneous oncology, continued following the Patient after Dr. Menn's death. T.G. died from other causes in 1989. She had no recurrence of basal cell carcinoma following the Mohs surgery. The evidence established that the Respondent is a capable and dedicated physician. There is no evidence that the Respondent manipulated the Patient for his own financial gain. It is clear that at the time this case was initiated, there were some erroneous factual assumptions made by at least one expert retained by the Petitioner. Petitioner sent the Patient's medical records for review by Dr. Joseph Rosen. His opinion served as one of the grounds for the initial finding of probable cause in this case and the subsequent issuance of the Administrative Complaint. That opinion was premised on the erroneous assumption that the Respondent never referred the Patient to a dermatologist for treatment. At the hearing in this cause, Dr. Rosen amended his opinion and acknowledged that a referral did take place. However, he felt that the Respondent had still failed to meet the applicable standard of care because he failed to take adequate steps to ensure that the Patient's basal cell carcinoma was treated. This issue is addressed in the conclusions of law below.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medical Examiners enter a Final Order finding the Respondent, Jules G. Minkes not guilty of the allegations contained in Count I of the Administrative Complaint and dismissing that Count, but finding Respondent guilty of Count II and III, issuing a letter of concern and imposing a fine of $500.00. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 13th day of December, 1990. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of December, 1990.
The Issue The issue in this case is whether Petitioner is entitled to an award of attorneys' fees and costs pursuant to Section 57.111, Florida Statutes, and Rule 60Q-2.035, Florida Administrative Code.
Findings Of Fact Based upon the record in this proceeding, the following findings of fact are made: At all times pertinent to this proceeding, Petitioner, Jules G. Minkes, was licensed as an osteopathic physician in the State of Florida having been issued license number 0S001516. For purposes of this proceeding, there is no dispute that Dr. Minkes qualifies as a small business party as defined in the FEAJA. In approximately May of 1988, the Department of Insurance notified the Department of Professional Regulation of a closed claim regarding Dr. Minkes. 2/ Specifically, the notice advised that an indemnity had been paid on behalf of Dr. Minkes to a patient T. G. (the "Patient") in the amount of $150,000 in settlement of a claim that Dr. Minkes had allegedly failed to diagnose and treat the Patient's basal cell carcinoma. The Department assigned an investigator to the case who notified Dr. Minkes of the investigation by letter dated June 26, 1988. The investigator interviewed Dr. Minkes and Dr. Munzer, a dermatologist who treated the Patient upon Dr. Minkes' referral. The Investigator also obtained the Patient's medical records from Dr. Minkes and several other physicians who treated her. From the outset of the Investigation, Dr. Minkes' maintained that the Patient had lied in connection with her claim. The investigator did not interview the Patient nor her husband, nor did the Investigator contact any of the individuals identified by Dr. Minkes as having knowledge of the case. The notes of the Investigator's interview with Dr. Minkes and the Patient's medical records were sent to an osteopathic physician with similar credentials to Dr. Minkes, a specialist in internal medicine. Joseph H. Rosin, D. O., was the expert retained by the Department to review Dr. Minkes' treatment of the Patient. In a report dated January 18, 1989, Dr. Rosin opined that Dr. Minkes' care of the Patient did not meet community standards. In particular, the Report noted that the Patient had a clear history of invasive basal cell carcinoma and Dr. Minkes failed to provide adequate treatment when it was known to have reoccurred. Dr. Rosin stated that it was not the standard of care in the community for an internist such as Dr. Minkes to treat extensive basal cell carcinoma, that surgical intervention and proper follow-up care by a dermatologist was necessary and the Patient's locally invasive carcinoma, which had been confirmed by a biopsy performed by Petitioner, should have been treated in a more timely and appropriate manner. After the consultant's report was obtained, the investigative file was completed and sent to Tallahassee for review by the investigator's supervisors in Tallahassee. The complete investigative report was reviewed and approved by the investigator's supervisor on January 31, 1989. On June 7, 1989, the Department's investigative file was forwarded to members of the Probable Cause Panel (the "Panel") of the Board along with a copy of the Department's recommendation to find probable cause and a copy of a proposed Administrative Complaint. The Panel, consisting of one lay member from the Board who was serving as chairman of the Panel and a licensed osteopathic physician, met on June 16, 1989. Both members acknowledged that they had received the materials sent to them and had reviewed the materials prior to the meeting. An assistant attorney general was present to answer any questions concerning the Panel's duties and/or the proper interpretation of the applicable laws or rules. A prosecuting attorney for the Board was also present to discuss the Department's recommendation to file an Administrative Complaint. The transcript of the June 16, 1989 Panel meeting reflects little discussion of the case. The Panel members concurred with the Department's recommendation and authorized the filing of the Administrative Complaint against Dr. Minkes. The Department filed the Administrative Complaint against Dr. Minkes' license to practice osteopathic medicine on or about June 20, 1989. That Administrative Complaint included three charges. Count I charged Dr. Minkes with violating Section 459.015(1)(r), Florida Statutes, as a result of his alleged failure to refer the Patient to a specialist for adequate treatment of her basal cell carcinoma, thus exploiting her for his own financial gain. Count II charged Dr. Minkes with violating Section 459.015(1)(p), Florida Statutes, by failing to keep medical records justifying his course of treatment of the Patient. Count III charged Dr. Minkes with violating Section 459.015(1)(y), Florida Statutes, by failing to practice osteopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. Although the allegations in the Administrative Complaint are somewhat vague and ambiguous, it arguably charges Dr. Minkes with malpractice because he failed to refer the Patient for proper treatment of her basal cell carcinoma, he attempted to treat the Patient's growing recurring basal cell carcinoma himself even though it was a condition which the Administrative Complaint alleges should have been treated by a specialist in that area of medicine, and he ignored the Patient's basal cell carcinoma. Most of the allegations contained in the Administrative Complaint were consistent with and apparently based upon the allegations made in the civil complaint filed by the Patient and her husband against Dr. Minkes. A copy of the civil complaint was contained in the Department's Investigative File. (It was the settlement of that civil law suit which prompted the investigation by the Department.) The charge that Dr. Minkes had not referred the Patient to a specialist for treatment was also supported by the Department investigator's conversation with Dr. Munzer, whom Dr. Minkes had identified as the specialist to whom he had referred the Patient. A formal administrative hearing was held before the undersigned Hearing Officer pursuant to Section 120.57(1), Florida Statutes. Following the conclusion of that hearing, a Recommended Order was issued on December 13, 1990, recommending the dismissal of Count I, but recommending that a Final Order be entered finding Petitioner guilty of Counts II and III. As noted above, the Department's investigative file does not include any interviews with the Patient or her husband to confirm the allegations that were made in the civil law suit. However, the Department presented the testimony of the Patient's husband during the hearing in the Underlying Proceeding and, in addition, the previously transcribed testimony of the Patient was also accepted into evidence. (The Patient had died of unrelated causes prior to the hearing in the Underlying Proceeding.) As noted in Finding of Fact 35 of the Recommended Order, both the Patient and her husband testified that Dr. Minkes advised them that he could treat the Patient's basal cell carcinoma and that he in fact attempted to do so. If this testimony had been accepted as credible, it would have been sufficient when considered with the other evidence presented, to establish that Dr. Minkes was guilty of all of the allegations contained in the Administrative Complaint. However, after considering all of the evidence, that testimony was specifically rejected. Notwithstanding the conclusion that Dr. Minkes did not attempt to treat the Patient's basal cell carcinoma himself as alleged in the Administrative Complaint, the Recommended Order concluded that certain violations had been established. As set forth in paragraphs 8 through 13 of the Conclusions of Law, the undersigned Hearing Officer concluded that Dr. Minkes' records regarding the Patient were deficient and that his treatment fell below the standard of care expected of a reasonably prudent physician under similar conditions and circumstances. Dr. Minkes filed exceptions to the Recommended Order arguing that the factual grounds for the violations found in the Recommended Order were not specifically alleged in the Administrative Complaint. The Board apparently agreed with this contention since, in its Final Order, the Board adopted all of the Findings of Fact in the Recommended Order, but dismissed the charges in the Administrative Complaint. Some of the charges in the Administrative Complaint presume that Dr. Minkes attempted to treat the Patient's basal cell carcinoma. In particular, the Administrative Complaint refers to several instances when Dr. Minkes hyfercated lesions on the Patient's forehead. The Administrative Complaint suggests that these instances were improper attempts to treat the Patient's basal cell carcinoma. The evidence presented at the hearing was insufficient to overcome Dr. Minkes contention that his clinical observations justified his conclusions that these lesions were keratotic and not related to the Patient's basal cell carcinoma. This testimony by Dr. Minkes and the rejection of the testimony of the Patient and her husband on this matter undermined some of the fundamental presumptions in the Administrative Complaint. Nonetheless, the undersigned Hearing Officer concluded that the evidence was still sufficient to establish violations of the statutory provisions cited in Counts II and III of the Administrative Complaint. The Board's apparent determination that the violations found in the Recommended Order were not adequately alleged in the Administrative Complaint does not obviate the conclusion that violations of the charged statutes were found to have in fact occurred. Dr. Minkes complains that the consultant's opinion which led to the Panel's finding of probable cause indicates that Dr. Minkes did not refer the Patient to a specialist for treatment when, in fact, such a referral was made to Dr. Munzer. This matter was recognized in Findings of Fact 67 of the Recommended Order. As noted in that Finding, the consultant subsequently acknowledged the referral to Dr. Munzer and amended his opinion. The consultant still felt that Dr. Minkes failed to meet the applicable standard of care because he failed to take adequate steps to insure that the Patient's basal cell carcinoma was treated. It should be noted that there are many unresolved questions regarding the scope of Dr. Minkes' referral to Dr. Munzer. Dr. Munzer's statement to the Department's investigator and his deposition testimony offered into evidence during the Underlying Proceeding regarding his treatment of the Patient differed greatly from Dr. Minkes' version of the referral. Dr. Munzer claimed that he did nothing more than evaluate the Patient's biopsy. He claimed that he told Dr. Minkes that the Patient needed chemosurgery, but Dr. Minkes continued to treat her. Dr. Munzer disclaimed any responsibility for treating the Patient's basal cell carcinoma and states that he would not have agreed to treat her condition because he was not qualified to do so. In determining whether probable cause existed to file the Administrative Complaint, the Panel was not required to, and did not attempt to, reconcile this discrepancy between Dr. Minkes and Dr. Munzer. Dr. Minkes also points out that Dr. Tytler, whose opinion was not available at the time the Administrative Complaint was filed but whose subsequent deposition was accepted into evidence at the final hearing, testified that there was no indication in the Patient's medical records that Dr. Minkes ever treated or attempted to treat the Patient's basal cell carcinoma as alleged in the Administrative Complaint. However, Dr. Tytler did testify that Dr. Minkes' treatment of the Patient did not meet community standards in certain respects. Without question, there were some gaps and/or oversights in the Department's investigation. In retrospect, the Department perhaps should have recognized the possibility that the Patient's version of events might not be accepted in its entirety in which case the Administrative Complaint could have been drafted in a manner that would have minimized the impact of such a conclusion. Notwithstanding these deficiencies, there was sufficient evidence for the Panel to conclude that the Patient had received substandard care. Even if the Patient's own decisions contributed to the delay in treating her basal cell carcinoma, there was clearly a lack of understanding and/or miscommunication between Dr. Minkes and Dr. Munzer as to how the Patient was to be treated. While there were conflicting versions as to who was responsible for this breakdown in communication, there was some evidence considered by the Panel which would reasonably indicate that the violations alleged had indeed occurred. After considering all of the circumstances, it is concluded that the Department was substantially justified in filing the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is ORDERED that Dr. Minkes' Petition for Attorney's Fees and Costs is DENIED. DONE AND ENTERED this 27th day of February 1995 in Tallahassee, Leon County, Florida. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of February 1995.
The Issue The issue in the case is whether the allegations in the Administrative Complaints are correct and, if so, what penalty should be imposed.
Findings Of Fact At all times material to this case, the Respondent was a licensed physician in the State of Florida, holding license number ME0039986. DOAH Case Number 01-3795PL Between May 22 and June 5, 1998, the Respondent ordered a series of diagnostic lab tests for Patient C. H., a 63-year- old female. As to the care provided to Patient C. H., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient C. H. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. According to the hemoglobin test performed on Patient C. H., the patient was diabetic and the diabetes was uncontrolled. The Respondent did not provide proper treatment to the patient for the diabetes. According to one of the lab tests, Patient C. H. was deficient in calcium. The Respondent did not provide appropriate treatment for the calcium deficiency. Although there was no medical indication that Patient C. H. had a thyroid problem, the Respondent prescribed a thyroid hormone medication. The thyroid medication was inappropriate and could have exacerbated the diabetic condition. DOAH Case Number 01-3796PL The Petitioner introduced into evidence an advertisement that appears to have been published in the June 25, 1999, edition of the "Sun-Sentinel Community News." There is no evidence that the Respondent created, read, placed, or paid for the advertisement in the newspaper. The ad offered a complementary consultation with the Respondent, who was identified in the ad as a diplomate of the "American Board of Anti-Aging." Florida law requires that a disclaimer appear in such advertisements advising a patient of the right to essentially decline non-free services that are recommended on the basis of the free consultation. The cited advertisement did not include the disclaimer. The Petitioner's administrative rules prohibit advertisement of affiliation with groups not "recognized" by the Petitioner. The Petitioner has not approved of the "American Board of Anti-Aging." DOAH Case Number 01-3797PL Patient D. E. On or about July 21, 1998, the Respondent ordered a series of diagnostic lab tests for Patient D. E., a 53-year-old male. According to the records, Patient D. E. had complained of impotency and loss of sexual desire. As to the care provided to Patient D. E., the Petitioner presented the testimony of Timothy Shapiro, M.D., whose testimony was persuasive and is credited. According to Dr. Shapiro, many of the tests performed on Patient D. E. were not medically indicated according to a review of the information set forth in the patient's medical records. At least one of the tests performed on several of the patients referenced herein (the "Barnes Basil Temperature Test") is not recognized in the medical community as providing valid information for the conventional diagnosis or treatment of any disorder. On or about August 18, 1998, the Respondent diagnosed Patient D. E. with hypothyroidism, panhypothyroidism, food allergies, and impotence of organic origin. He prescribed Cytomel, Armour Thyroid, and testosterone gel for the patient. According to the testimony of Dr. Shapiro, the prescribed medications were inappropriate because the medical record fails to indicate any deficiencies being addressed by the medication. The course of treatment provided for the patient is not documented by the medical records and is below the standard of care. Patient J. N. On or about August 27, 1998, the Respondent ordered a series of diagnostic lab tests for Patient J. N., a 50-year-old female. According to the records, Patient J. N.'s symptoms included fatigue, numbness, tingling and burning in the extremities, muscle and head aches, insomnia, swelling, depression and easy bruising. As to the care provided to Patient J. N., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient J. N. were not medically indicated according to a review of the information set forth in the patient's medical records. On or about September 10, 1998, the Respondent diagnosed Patient J. N. with chronic fatigue, probable hypothyroidism, and unspecified liver disorder. An existing diagnosis of ischemic heart disease was confirmed; he prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel, Hydrocortisone, Rezulin, and a female hormonal transdermal gel) were inappropriate and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent. Patient T. B. On or about October 8, 1998, the Respondent ordered a series of diagnostic lab tests for Patient T. B. (also identified as T. P.) a 49-year-old female. According to the records, Patient T. B.'s symptoms included muscle ache, migraines, insomnia, vaginal discharge, and neck, back and stomach pain. As to the care provided to Patient T. B., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient T. B. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. On or about October 21, 1998, the Respondent diagnosed Patient T. B. with hyperthyroidism, migraine headaches, chronic fatigue, yeast infection, and unspecified disorder of the intestines, stomach, and duodenum. He prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel and Armour Thyroid) were inappropriate and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent. The Respondent failed to perform a pelvic examination or to refer the patient to a gynecologist despite the diagnosis that she was suffering a yeast infection, and therefore failed to meet the applicable standard of care. The diagnosis of unspecified disorder of the stomach, duodenum, and intestines was apparently based on described pain. There is nothing in the medical record indicating that appropriate testing to determine causality was ordered or performed. Patient A. M. On or about August 26, 1998, the Respondent ordered a series of diagnostic lab tests for Patient A. M. According to the records, Patient A. M.'s symptoms included muscle and head ache, constipation, cramps and menstrual irregularity, decreased libido, sore throat and sinus problems. As to the care provided to Patient A. M., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient A. M. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. On or about September 9, 1998, the Respondent diagnosed Patient T. B. with hypothyroidism, chronic fatigue, hyperinsulinemia, and unspecified ovarian dysfunction. The lab test results do not support the diagnosis. On December 2, 1998, the Respondent prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel, Rezulin, Glucophage, glycine, and fish oil) were inappropriate for the patient and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration, Board of Medicine, enter a final order suspending the medical license of Robert M. Knight, M.D., for a period of one year followed by five-year period of probation, and imposing an administrative fine of $5,000. DONE AND ENTERED this 19th day of April, 2002, in Tallahassee, Leon County, Florida. ___________________________________ WILLIAM F. QUATTLEBAUM 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 19th day of April, 2002. COPIES FURNISHED: Kathryn E. Price, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Robert M. Knight, M.D. 5650 Camino del Sol, Number 101 Boca Raton, Florida 33433 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Mr. R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Conclusions The attending nurse's actions and inactions fell below the standard of professional care applicable under the circumstances. The consequences of a below normal fetal heart rate are so critical that, even if the nurse was suspicious that the monitor was not working properly, her proper response should have been to take immediate steps to determine whether the fetus was in distress, to intervene with resuscitation measures if needed, and to alert a doctor. Her failure to take appropriate action was negligence and was the proximate cause of the injuries suffered by Janaria. South Broward Hospital District, doing business as Memorial Regional Hospital, is liable as the nurse's employer. There are many reasons for entering into a settlement agreement other than the perceived merits of the claim and, therefore, I am not precluded from reviewing the terms of the parties' settlement agreement in this matter and determining whether they are reasonable under the totality of the circumstances. In this case, the settlement amount is far less than the usual jury verdict for injuries of this nature. Had this case involved a private hospital, the settlement amount would probably have been much larger. Therefore, I believe it would be fair and reasonable for the Senate to pay an award of $550,000 (or 50 percent more than the agreed settlement amount). ATTORNEY’S FEES AND LOBBYIST’S FEES: In compliance with s. 768.28(8), F.S., the Claimants' attorneys will limit their fees to 25 percent of any amount awarded by the Legislature. However, Claimants’ attorneys did not acknowledge their awareness of the provision of the bill that limits attorney’s fees, lobbyist’s fees, and costs to 25 percent of the award. They propose a lobbyist's fee that would be an additional 6 percent of any award. OTHER ISSUES: The bill should be amended to correct the name of the defendant to South Broward Hospital District. Of the two annuity options presented by the Claimants' attorney, I believe the option that guarantees payment for 40 years is the better option. In addition, because Shakima Brown received nothing in the settlement, I believe the bill should specify that, in the event that Janaria dies before the trust fund is exhausted, the balance in the trust fund should go to Ms. Brown. The District stated that paying a claim in the amount of $300,000 would not impair its ability to provide normal services. RECOMMENDATIONS: For the reasons set forth above, I recommend that Senate Bill 38 (2008) be reported FAVORABLY, as amended. Respectfully submitted, cc: Senator Ted Deutch Representative Kelly Skidmore Faye Blanton, Secretary of the Senate Bram D. E. Canter Senate Special Master House Committee on Constitution and Civil Law Tony DePalma, House Special Master Counsel of Record
