Findings Of Fact The decedent, James C. Daniels, was employed as a fire fighter with the Village of Miami Shores, Florida, in April of 1972. The Miami Shores Fire Department was subsequently assimilated by Metropolitan Dade County, Florida, and at the time of the decedent's death on July 20, 1976, he was employed by Dade County as a fire fighter/emergency medical technician. On November 4, 1975, the decedent received a physical examination which showed no evidence of heart disease, and an electrocardiogram, the results of which were within "normal" limits. The decedent had no history of heart disease or circulatory problems, did not drink, and began smoking only in 1974 or 975. At the time of his death, the decedent's customary work routine involved 24 hours on duty, from 7:00 a.m. to 7:00 a.m., followed by 48 hours off duty. The decedent's duties included answering emergency calls along with his partner in a rescue vehicle. These calls included such incidences as automobile accidents, fires, violent crimes involving injuries to persons, and various and sundry other emergency situations. Upon answering an emergency call, the decedent was required by his job to carry heavy equipment, sometimes weighing as much as 80 pounds, to the place where the injured person was located. On occasion, the decedent would transport injured persons from the scene to local hospitals. At the time of his death, the decedent appeared outwardly to be in good physical condition. In fact, he engaged in a regular program of physical exercise. During the approximately two months prior to his death, the decedent participated in a busy work schedule which often included numerous rescues, in addition to false alarms and other drills required of his unit. In fact, only four days prior to his death, the decedent and his partner during one twenty- four hour shift, were involved in 13 rescues and one building fire. During that day, the decedent worked for 24 straight hours, apparently without sleep. On July 19, 1976, at 7:00 a.m., the decedent began his last work shift prior to his death. During that day, the decedent's unit participated in two rescues and two drills. That evening, several of decedent's fellow workers noticed that he looked "bad", "tired" or "drawn out". During the night, decedent was observed getting out of bed from three to five times, and holding his left arm, left side or armpit. At 7:00 a.m. on July 20, 1976, the decedent went off duty and returned home. Upon returning home, he ate breakfast, and later washed down a new brick fireplace at his home. After showering, resting and eating a lunch, he joined several other men near his home whom he had agreed to help in pouring cement for some new construction. The decedent mentioned pains in his neck and shoulder to these men before the truck carrying the cement arrived. The decedent mentioned that he had been under a lot of tension and pressure as a result of the busy work schedule at the fire station. When the cement truck arrived, cement was poured into several wheelbarrows and several of the men, including the decedent, pushed the wheelbarrows to the rear of the structure on which they were working. It appears that the decedent pushed approximately four wheelbarrow loads of cement weighing about 75 pounds each to the rear of the structure. Approximately one-half hour elapsed during the time that the decedent was engaged in this activity. Soon thereafter, the decedent was observed to collapse and fall to the ground. He was given emergency medical treatment and transported to Palmetto General Hospital, where he was pronounced dead at 5:24 p.m. on July 20, 1976. An autopsy was performed on the deceased on July 21, 1976 by Dr. Peter L. Lardizabal, the Assistant Medical Examiner for Dade County, Florida. In pertinent part, the autopsy showed moderate arteriosclerosis of the aorta, and severe occlusive arteriosclerosis of the proximal third of the anterior descending coronary artery in which the lumen, or opening, through which the blood passes through the artery was hardly discernible. The remaining coronary arteries appeared unaffected by the arteriosclerosis. The decedent's certificate of death, which was also signed by Dr. Lardizabal, listed the immediate cause of death as acute myocardial infarction due to severe occlusive arteriosclerosis of the left coronary artery. Dr. Lardizabal performed the autopsy examination of the decedent by "gross" observation, that is, without the benefit of microscopic analysis. However, microscopic slides were made during the course of the autopsy which were subsequently examined by other physicians whose testimony is contained in the record of this proceeding. Findings contained in the autopsy report, together with an evaluation of the aforementioned microscopic slides, establish that the myocardial infarction suffered by the decedent occurred at least 24 hours, and possible as many as 48 hours, prior to the decedent's death. This conclusion is based upon the existence of heart muscle necrosis, or tissue death, which would not have been discernible had the decedent died immediately following a coronary occlusion. In fact, for a myocardial infarction to he "grossly" observable at autopsy, that is, without the benefit of microscopic examination, it appears from the record that such an infarction would have to occur a substantial period of time prior to the death of the remainder of the body. Otherwise, the actual necrosis of heart muscle tissue would not be susceptible to observation with the naked eye. Although it appears probable from the evidence that the decedent went into a type of cardiac arrhythmia called ventricular fibrillation which led to his death, the actual proximate cause of his death was the underlying myocardial infarction, which in turn was a result of arteriosclerosis which had virtually shut off the supply of blood to the affected area of his heart. Although the causes of arteriosclerosis are not presently known to A medical science, it appears clear from the record that acute myocardial infarctions can be caused by emotional or physical stress, and that the decedent's myocardial infarction was, in fact, caused by the stress and strain of his job as a fire fighter and emergency medical technician. In fact, it appears from the medical testimony in this proceeding that the decedent was having a heart attack which led to the myocardial infarction on the night of July 19, 1976, or in the early morning hours of July 20, 1976, while he was still on duty. It further appears that, although physical exertion, such as the pushing of the wheelbarrow loads of cement by the decedent, might act as a "triggering mechanism" for ventricular fibrillation, the decedent's activities on the afternoon of July 20, 1976, had very little to do with his death. The type of lesion present in the decedent's heart, which had occurred as much as 48 hours prior to his death, was of such magnitude that he would likely have died regardless of the type of physical activity in which he engaged on July 20, 1976. Petitioner, Dolores A. Daniels, is the surviving spouse of James C. Daniels.
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 Respondent violated Section 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this proceeding, Dr. Ford was a licensed physician in the State of Florida. His license, numbered ME 0051042, was issued on July 8, 1987. Patient R.A.L, presented to the Emergency Department of Winter Haven Hospital (Hospital) at approximately 1:35 p.m. on October 9, 1997. R.A.L.'s initial chief complaint was right flank pain since 9:00 a.m. that day. He reported a history of vomiting and diarrhea and stated that it felt like a kidney stone, of which R.A.L. had a history. Right flank pain is common with a patient having a kidney stone or kidney problem. R.A.L. was initially examined by Dr. David Siegel about 30 minutes after R.A.L. came to the emergency room. On physical examination palpation, there was no flank pain, but R.A.L. did have moderate pain diffusely throughout all areas of his abdomen. His abdomen was not acutely distended, and there were normal bowel sounds. On Dr. Siegel's order R.A.L. was given Toradol intravenously at 2:22 p.m. to relieve the pain. Toradol is a non-steroidal anti-inflammatory drug. R.A.L. was also given fluids intravenously. R.A.L.'s symptoms did not provide Dr. Siegel with a definitive diagnosis. Dr. Siegel ordered the following tests to be performed: a complete blood count, an amylase, a urinalysis, a PTPDT, and X-rays of the abdomen. The complete blood count was done to make sure that the patient was not anemic and to see if there was an elevated white blood count, which would be indicative of some type of infection or acute abdominal process. The complete blood count showed a significantly elevated white blood cell count of 24.3. The test also revealed that there was a left shift of a differential, which means that there was a high differential percentage-wise of segmented and banded white blood cells. The combination of the significantly elevated white blood cell count and the left shift indicated that there was an acute infectious process or an acute illness. The amalyse test measures a serum enzyme that is secreted from the pancreas. If the serum enzyme is elevated, it could be indicative of pancreatitis. The amalyse test was normal. The urinalysis would show whether there was an infection and would show some abnormalities if there were a kidney stone. R.A.L.'s urine checked out normal. At 3:00 p.m. R.A.L. voided. His urine was strained, but there were no kidney stones present. R.A.L. did not have an adequate response to the Toradol. He was given Demerol intravenously at 3:10 p.m. Based on the test results, Dr. Siegel was unable to make a definitive diagnosis. Because of R.A.L.'s clinical condition and his continued pain, Dr. Siegel ordered an abdominal Computed Tomography (CT) scan to see if he could further define what was going on in R.A.L.'s abdomen. Because of the absence of flank pain, the elevated white blood cell count, and the normal urinalysis report, Dr. Siegel did not rule out the possibility of kidney stones, but did feel that some abdominal process of significance was higher on the list of possible diagnoses than kidney stones. Dr. Siegel went off duty at 5:30 p.m. and turned the care of R.A.L. over to Dr. Ronald Barbour. Dr. Siegel gave Dr. Barbour an oral report of his findings and indicated that he was primarily concerned about a serious intra-abdominal process. Before finishing his shift, Dr. Siegel dictated a written report, which was immediately transcribed and placed in R.A.L.'s chart. Dr. Siegel expected Dr. Barbour to get the results of the CT scan and determine whether the results would allow a diagnosis. When Dr. Barbour came on duty, he went to see R.A.L., who told Dr. Barbour that he was still having some pain. R.A.L. asked for something to relieve the pain, and Dr. Barbour ordered Demerol for him. Dr. Barbour received a call from the radiologist, who said that the CT scan was consistent with a small bowel obstruction. Dr. Barbour told R.A.L. that it appeared he had a bowel obstruction and that he would be admitted to the Hospital. It is the Hospital's policy to contact a patient's primary care physician when a patient is being admitted to the Hospital from the Emergency Department. Dr. Ford was R.A.L.'s primary care physician. Dr. Ford was called by an Emergency Department nurse. Dr. Barbour spoke with Dr. Ford and advised him that the CT scan showed a small bowel obstruction. Dr. Ford stated that he would admit R.A.L. No mention was made of a surgical consult during the conversation. Dr. Barbour did not call a surgeon for a consult because normally if the patient has a primary care physician, the primary care physician would choose the surgeon should a surgical consult be necessary. R.A.L. was admitted to the Hospital at approximately 8:45 p.m. At that point, the responsibility for the care and treatment of the patient shifted from Dr. Barbour to Dr. Ford. Dr. Ford gave admission orders to Lorina Duncan, a nurse in the Emergency Department. The orders included administering Demerol and Phenergan as needed and giving the patient a saline solution intravenously. Dr. Ford also ordered tests to be done the following morning. The nurse's notes do not indicate that Dr. Ford told her to order a surgical consult for the next morning. R.A.L. was given Demerol and Phenergan in the Emergency Department at 9:55 p.m. At 10:10 p.m. R.A.L. was signed out of the Emergency Department to the medical/surgical floor of the Street Building, which is known as Street One. When R.A.L. was admitted to the Hospital, his abdomen was not distended. By the time he was admitted to Street One, his abdomen was distended and firm, and he was complaining of abdominal pain and nausea. When he was placed in his bed, he positioned himself in a fetal position, which is indicative of being in pain. He had no bowel sounds. While the nurse was getting a medical history, R.A.L. was lethargic and would drift off in the middle of the admission questions. His breathing was shallow and rapid. It took the nurse over an hour to complete the admission assessment on R.A.L. after he had come to Street One. At 11:50 p.m., R.A.L. was complaining that his pain had increased throughout his stomach. He indicated that his nausea was better. R.A.L. requested a patient-control anesthetic (PCA), which allows the patient to administer a metered dose of pain medication to himself by pushing a button. Around midnight the nurse had the hospital operator page Dr. Ford. He returned the nurse's call. She told Dr. Ford that R.A.L.'s abdomen was distended and that he was lethargic. R.A.L. had had no pain medication administered since being admitted to Street One, and his next dose of pain medication was to be given at 1:00 a.m. The nurse told Dr. Ford that R.A.L. was complaining of pain and wanted to have a PCA. Dr. Ford gave an order for a Demerol PCA, which would allow a five-milligram dose every five minutes with a maximum of 150 milligrams in four hours. The nurse told Dr. Ford that R.A.L. had been complaining of nausea. Dr. Ford asked whether R.A.L. had vomited, and she advised the doctor that R.A.L. had not. They discussed the possible use of a naso-gastric (NG) tube, which extends from the nose down to the stomach. It is used to aspirate the contents of the stomach, which decreases nausea and distention. Dr. Ford did not order a NG tube. At 12:30 a.m., October 10, 1997, the Demerol PCA was started. At 4:30 a.m., R.A.L. was complaining of shortness of breath. His abdomen was more distended and firm. Dr. Ford was paged, and he gave orders for lab work to be done. At 4:45 a.m. R.A.L. went into distress and died. Dr. Ford arrived at the Hospital about 5:05 a.m. A small bowel obstruction is a condition characterized by the inability of gastrointestinal fluid and material to pass through the small bowel due to some sort of blockage. Symptoms include pain, nausea, vomiting and a change in or cessation of bowel sounds. Small bowel obstructions generally cause the bowels to become inflamed and swollen, which can lead to a cut off of the blood supply to the bowel and result in the rupture of the bowel. If the bowel ruptures, it is a very acute, life-threatening situation which must be treated rapidly. Small bowel obstructions are generally classified as a partial or simple obstruction, and a complete or strangulated obstruction. A strangulated small bowel obstruction means the vascular system has been compromised and the blood supply to a part of the bowel has been cut off. If the blood supply has been cut off, the bowel tissue will become gangrenous, then necrotic, and finally die. Surgery can alleviate the strangulation. Strangulated small bowel obstructions represent 20 to 40 percent of all small bowel obstructions. Post-operative adhesions, bands of scar tissue which form inside the abdomen, are the predominate cause of strangulated bowel obstructions. Severe and constant pain, as opposed to cramping, intermittent pain, can characterize a strangulated small bowel. A strangulated small bowel is a very serious condition. Diagnosis requires obtaining a careful history, recognition of previous operations, a "hands on" physical examination and diagnostic testing. With a small bowel obstruction, a patient’s condition can change rapidly, sometimes in a matter of hours. Because any change in the condition of the patient can indicate a significant problem, serial abdominal examinations are important. Early detection and evaluation of complications from small bowel obstructions are also important. In the case of R.A.L., the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances would have been for Dr. Ford to come to the Hospital and physically examine R.A.L. when the patient was admitted to the Hospital under his care and after Dr. Ford was called by the nurse around midnight, apprising him of R.A.L.’s condition. Dr. Ford did not come to the Hospital to examine from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died. A strangulated bowel is a surgical emergency. If a physician fails to diagnose and treat a strangulated small bowel, the patient will likely die. The physician will normally consult a surgeon when the patient presents with a small bowel obstruction. In performing a surgical consult, the surgeon will make the determination of whether and when to perform surgery. The sooner the surgeon is involved, the less the chances of compromising the patient’s bowel or general physical condition. Calling a surgeon early in the course of treating a patient with a small bowel obstruction is the prudent thing to do. In the case of R.A.L., the level of care, skill, and treatment, which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, would have been for Dr. Ford to call for a surgical consult when R.A.L. was admitted to the Hospital under his care. Dr. Ford did not call for a surgical consult from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Ronald A. Ford, M.D. violated Section 458.331(1)(t), Florida Statutes, placing him on two years' probation, imposing an administrative fine of $5,000, and requiring him to take five hours of continuing medical education in the area of risk management and 16 hours of continuing medical education in the area of diagnosing and treating abdominal and gastrointestinal disorders. DONE AND ENTERED this 5th day of February, 2002, in Tallahassee, Leon County, Florida. ___________________________________ SUSAN B. KIRKLAND 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 5th day of February, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 William B. Taylor, IV, Esquire McFarland, Ferguson & McMullen 400 North Tampa Street Suite 2300 Tampa, Florida 33620 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, 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
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, in that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, by failing to treat the patient's preoperative coagulopathy and/or failing to use an alternate vein that would have allowed visualization of the shunt placement into the vein thereby reducing the risk of causing a hemorrhage given the patient's preoperative history, and, if so, what penalty should be imposed. AS TO CASE NO. 01-4407PL Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to distally clamp part of the arteries prior to manipulation of the aneurysm and by failing to ensure periodic monitoring of the patient's condition postoperatively for evidence of ischemia or other problems and, if so, what penalty should be imposed.
Findings Of Fact Based on the evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: FACTS COMMON TO BOTH CASES Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapters 456 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0036360. Respondent is board-certified in thoracic and general surgery. FACTS RELATED TO CASE NO. 01-4406PL Patient D.J.P. was a 54-year-old female with a history of liver resection for carcinoma. Patient D.J.P. had contracted Hepatitis C in the 1960s from a blood transfusion, after being the victim of a gun shot wound during a robbery at a convenience store. Patient D.J.P. subsequently had developed cirrhosis secondary to the Hepatitis C. Cirrhosis is a scarring process of the liver that results in the displacement of the normally functioning liver tissue. A healthy liver processes lymphatic fluid back into the bloodstream. However, a cirrhotic liver cannot properly process the lymphatic fluid back into the bloodstream. Therefore, lymphatic fluid backs up within the liver and weeps out the covering over the liver and into the abdominal cavity. Patient D.J.P. presented to Respondent on February 1, 1994, after being referred to Respondent by Michael Carey, M.D., the primary care physician, for evaluation for implanting a peritoneal venous shunt. A venous shunt is a conduit designed to take ascitic fluid from the abdomen and put it back in the vascular system. The shunt removes the fluid from the abdominal cavity and transports it to the vascular system where it can be absorbed. The procedure is for the patient's comfort and does not prolong the patient's life. The procedure is for patients with end stage liver disease. After obtaining a medical history and conducting a physical examination, Respondent's assessment of the Patient D.J.P. was massive ascites secondary to cirrhosis and previous liver resection. Respondent believed that Patient D.J.P. was a candidate for a venous shunt procedure due to the fact that she was very symptomatic from her massive ascites and she was on the maximum medical therapy. The mortality rate for this type of procedure is between 5 and 25 percent or at the very least, one-in-twenty patients would die from this procedure. Complications associated with this type of procedure include disseminated intravascular coagulopathy (hereinafter referred to as "DIC") which may lead to the general worsening of the disease or death. The patient was informed of this mortality rate as well as of the complications associated with this procedure. Patient D.J.P. decided to think about the procedure and contact Respondent's office when she wanted the shunt inserted. On February 10, 1994, Patient D.J.P. called Respondent's office and asked to have the shunt inserted as soon as possible. Respondent scheduled the procedure for February 14, 1994, and signed the written surgical consent form. Prior to the surgery, lab tests were performed on Patient D.J.P. The lab report indicated that the patient's prothrombin time was 14.3, with a normal range being 10.7-12.8. Prothrombin time ("PT") is a measurement of one aspect of the blood clotting mechanism. This was considered slightly abnormal and not an indication of a clotting problem or coagulopathy. Respondent decided it was not necessary to address Patient D.J.P.'s abnormal PT prior to the procedure by preoperatively administering Vitamin K or fresh frozen plasma. On February 14, 1994, Patient D.J.P. was transported to the operating room at approximately 12:10 p.m. After Patient D.J.P. was placed under general anesthesia, Respondent began the venous shunt operation at approximately 12:34 p.m. Respondent attempted to access the right jugular vein to insert the shunt. He found this vein to be unusable because it was too scarred from previous surgeries. Respondent then proceeded to access the right subclavian area to insert the shunt. Once the shunt was inserted into the subclavian area, Respondent positioned it in the superior vena cava. The shunt was noted to be in position in the superior vena cava. Respondent then removed eight liters of ascitic fluid from the abdominal cavity. After removing the ascitic fluid, he then put one liter of saline into the abdominal cavity to dilute any remaining ascitic fluid which allowed any remaining fluid to be more easily absorbed into the vascular system. The Patient's central venous pressure dropped from 8 to 2. Hespan and Albumin were then administered to replace any lost volume and it helped to increase the colloidomotic pressure. At this point, Patient D.J.P.'s central venous pressure (CVP) increased from 2 to 14 or 15. This is a faster than normal rate. Upon finding that the shunt was operating well, Respondent closed the abdominal portion and the patient was extubated. Petitioner claimed that fluoroscopy was not used to ensure that the shunt was positioned in the proper place. A Fluoroscope is like a real-time X-ray. A fluoroscope has two parts to it: a C-arm, which goes above the patient and underneath the bed, and two screens where the doctor can see what is going on. The C-arm is approximately 5-and-a-half feet tall. It is below the standard of care to do a venous shunt procedure without using a fluoroscope. It would enable Respondent to visualize the placement of the shunt. Felicia Whitmer, a scrub technician, and Rene Myers, a circulating nurse, prepared the operating room for Patient D.J.P.'s procedure on February 14, 1994. Both Felicia Whitmer and Rene Myers testified that there was no fluoroscope in the operating room on February 14, 1994. Respondent testified that there was a fluoroscope in the operating room on February 14, 1994, during Patient D.J.P.'s procedure and that he used it to assist him. The evidence is not clear and convincing that the fluoroscope was not used during the course of the operation. It is considered within the accepted standard of care to access the right subclavian vein to insert a shunt of this type because this vein follows a gentle curve or path. With this gentle curve in the vein, there is less risk of damage, i.e. puncture, to the vein. In contrast, the left jugular vein follows a more sharp-angled 70-degree bend-curve in the vein where one risks the danger of the shunt coming out of the bottom of the vein or perforation and, thereby, damaging the vein. Respondent ordered an X-ray to confirm placement of the shunt and catheter. The X-ray revealed that the shunt had good positioning but the right lung was filled with fluid. The patient was re-intubated and Respondent inserted a chest tube into the patient which would expand the patient's lung, oxygenate the patient and allow for fluid removal. Three or four liters of fluid were removed. The fluid was originally serous and pink tinged and shortly thereafter, turned bloody. Respondent noted that there was bruising around the wounds. Additionally, the patient's breathing became shallow and her blood pressure began to deteriorate. Resuscitative efforts were performed and Respondent re- entered the shunt area to clamp the shunt to prevent any ascites from flowing into the venous system and to prevent further coagulation and massive bleeding. Despite heroic resuscitative efforts, the patient's condition continued to deteriorate and the patient died. The cause of death was determined to be DIC and severe coagulopathy from drainage of the ascitic fluid into the venous system. Respondent made the determination that the patient did not have preoperative coagulopathy. Respondent testified that if the patient did have preoperative coagulopathy, he would not have performed the procedure because the patient would not be able to make the clotting factors well enough for problems that would occur after the shunt was inserted. It was Respondent's opinion that the patient did not have a serious clotting problem. Based on her lab report, Patient D.J.P. had a slightly abnormal PT and this was not an indication of a clotting problem. Respondent reviewed the lab reports and determined the PT (the measurement of one aspect of blood clotting mechanism), to be only slightly elevated. It measured 14.3 with a normal range being 10.7-12.8. Moreover, the PT International Normalized Ratio (INR) (which is the standardized measurement of PT) was 1.63 where the therapeutic range was 2-3. Therefore, this was slightly below average. Dr. Yahr testified that an abnormal clotting problem is a clinically evident problem and not an incident of a lab number. If Patient D.J.P. had a clotting abnormality, adverse conditions or symptoms would have been evident with the incisions that were made prior to the shunt being opened. Rather, normal clotting reactions occurred. Coagulation occurred right after the shunt was opened and the ascitic fluid began to flow into the atrium. Dr. Yahr testified that the etiology of the coagulation was the body's reaction to the ascitic fluid after the shunt was opened. Accordingly, it was Dr. Yahr's opinion that Respondent did not fail to treat the preoperative coagulopathy because upon his examination of the patient, he determined that no such preoperative coagulopathy existed prior to the procedure. Dr. Yahr testified that the patient did not have abnormal bleeding. Her liver failure was the result of scarring and abnormal liver function. Therefore, administration of clotting factors such as Vitamin K and fresh frozen plasma was not indicated or medically necessary. Petitioner presented the expert testimony of John W. Kilkenny, III, M.D. Dr. Kilkenny is board-certified in general surgery and has been for 11 years and is currently a professor with the University of Florida College of Medicine, Department of Surgery in Jacksonville, Florida, a position which he has held for the last six years. According to Dr. Kilkenny, Patient D.J.P.'s elevated PT was a cause for concern in that it was an indication that the patient's ability to clot or coagulate was diminished. It is not clear and convincing that the standard of care required that the elevated PT be treated by infusing fresh frozen plasma or Vitamin K. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by failing to use an alternate vein that would allow visualization of the placement of the shunt. Respondent first attempted to access the right jugular vein to insert the shunt but found it be unusable because it was too scarred. Respondent, acting as a reasonably prudent physician and using sound medical judgment, accessed the right subclavian area to insert the shunt. After the shunt was inserted into he subclavian vein, Respondent claimed he was able to visualize the placement of the shunt by the use of fluoroscopy. Furthermore, the operative notes seemed to indicated that the procedure was performed under fluoroscopic control and the shunt was found to be in position. Therefore, Respondent accessed an appropriate alterative vein-the subclavian vein, which allowed visualization, with the assistance of fluoroscopy, of the placement of the shunt. As to the second issue, Dr. Kilkenny opined that the standard of care requires direct visualization for insertion of the shunt. By not accessing a vein under direct visualization, such as with Respondent's subclavian approach, the surgeon is, in essence, hunting for the vein, and risking damage to the wall of the vein that may not be evident immediately. The rapid rise in CVP from 2 to 14 or 15 was also a concern for Dr. Kilkenny because it was not normal, and did not mean that the shunt was placed correctly of that the shunt was functioning properly. Dr. Kilkenny noted that it was unlikely that the bleeding in the chest cavity was caused by damage to an intercostals vessel when the chest tube was inserted because the chest X-ray that was taken prior to insertion of the chest tube showed a complete opacification of the right side and a shifting of the major vessels within the middle of the chest over to the left side. According to Dr. Kilkenny, the chest X-ray indicated that there had already been some sort of bleeding in the right chest prior to the insertion of the chest tube. Dr. Kilkenny disputed Respondent's theory that Patient D.J.P. died as a result of DIC. Dr. Kilkenny asserted that Respondent fell below the standard lf care in that, given Patient D.J.P.'s rapid decompensation, he failed to consider whether the patient's subclavian vein had been damaged, a condition which could have been addressed surgically. Dr. Yahr opined that Patient D.J.P. died of DIC that occurred within a short period of time after Respondent opened up the shunt and ascitic fluid was introduced into the atrium of the heart. Although Dr. Yahr further admitted that the bleeding in the chest could have occurred as a result of damage to the subclavian vein, and that it was below the standard of care to access the subclavian vein without using fluoroscopy, the evidence is not clear and convincing that either event occurred. It is found that Petitioner has failed to establish by clear and convincing evidence that the standard of care required Respondent to use an access site that allowed direct visualization of the placement of the shunt into the vein, or that Respondent failed to use fluoroscopy in order to directly visualize insertion of the shunt into the subclavian vein. AS TO CASE NO. 01-4407PL On August 22, 1997, Patient H.H., a 55-year-old female, was diagnosed with an abdominal aortic aneurysm measuring approximately 4.5 cm transverse diameter and beginning approximately 1-2 cm below an enlargement or swelling, of a blood vessel resulting in a weakening or thinning out of the vessel wall. On November 28, 1997, Patient H.H.'s aneurysm had grown to 5 cm within a three-month period and was occluded with partial thrombosis with a true lumen around 2.7 cm and extended down to the bifurcation of the abdominal iliac. This put the patient at risk for rupture of the aneurysm. Thrombosis is a blood clot within a vessel or within the vascular system. It does not embolize (travel) from another part of the body. It starts in a particular vessel and causes its damage from there. It is an acute clot that occurs in the vessel secondary to stasis (non-moving ) or some kind of coagulation or clotting deficiency or abnormality. Thrombotic activity most often begins by occluding the smaller vessels in the vascular system, such as those smaller veins located in the feet. On December 2, 1997, Patient H.H. first met with Respondent, who performed a complete medical history and physical examination and confirmed the presence of a 5 cm abdominal aneurysm. Patient H.H. was a 55-year-old female who smoked 1- and-a-half packs of cigarettes per day, had a blood pressure of 182/104 despite the fact that she was taking 50 mg Atenolol for hypertension (high blood pressure), and had a 30 percent blockage of the coronary artery. Previously, she had a cardiac catheterization, followed by an angioplasty of the femoral vessel in her left leg. Patient H.H. advised Respondent that her legs gave out on her after she walked two blocks, but that she did not have associated chest pain. Respondent confirmed earlier diagnosis of Patient H.H.'s medical condition as single vessel coronary artery disease, abdominal aortic aneurysm, hypertension, and claudication with femoral occlusive disease. Respondent also found diminished femoral pulses and palpable Dorsal pedal pulses present in both feet. Patient H.H.'s medical records indicated that this smoker of 30 years suffered from diabetes, peripheral vascular disease, intermittent clottication of the leg, hypertension, atherosclerotic disease, hypercoagulopathy, anthithrombin III deficiency, high cholesterol, and diminished protein and pH levels. Respondent prescribed prescription medication, Procardia to lower Patient H.H.'s blood pressure and Zyban to help her stop smoking. He recommended that the patient return in a week for follow-up. On December 15, 1997, Respondent continued to prepare Patient H.H for surgery. He again advised her to stop smoking and to purchase and take medication to help her stop smoking. Patient H.H.'s blood pressure was lower, 144/84, and although she had not purchased or taken the medication, she reduced her smoking down to one-half pack of cigarettes per day. Respondent then advised Patient H.H. to make plans to undergo the abdominal aortic aneurysm ("AAA") repair. Patient H.H. informed Respondent that she wanted to wait a little longer while she made financial arrangements to pay for the surgery. Respondent advised Patient H.H. to completely quit smoking before the surgery and advised her to return in one month for additional preoperative evaluation. On January 12, 1998, Respondent continued to prepare Patient H.H. for surgery by ordering a cardiac clearance (thallium evaluation) of the patient's heart to ensure she could tolerate the surgery before attempting the AAA repair. On February 3, 1998, Patient H.H. presented for the thallium evaluation of the heart and, on February 9, 1998, obtained cardiac clearance for repair of the AAA. On February 11, 1998, Respondent continued to prepare Patient H.H. for AAA surgery and suggested she donate two units of blood which would be used during the surgical procedure. Respondent scheduled AAA repair surgery for March 6, 1998. Respondent advised Patient H.H. of the risks associated with AAA surgery and specifically mentioned the risk of a heart attack, bleeding, kidney damage and loss of legs. He also advised that the risks associated with intra-operative AAA repair include spontaneous rupture, embolization of material from the wall distally, myocardial infarction, bleeding, injury to viscera of the small vessels, devascularization of the colon causing ischemic colitis, death, kidney blockage. Patient H.H. indicated she understood the risks and despite the risks associated with this type of surgical procedure, including the risk of death, she agreed to the procedure. Preoperative testing by angiogram was not required for Patient H.H. The aneurysm was a massive aneurysm presenting a very serious health risk of imminent rupture. The size of Patient H.H.'s aneurysm (5 cm) made AAA repair an emergency in a sense because there was almost a 100 percent chance of rupture with in the next six months. Any findings determined by angiogram would not have changed the outcome of the case because Respondent had to definitively treat the aneurysm first. Additionally, an angiogram is a very expensive test and Patient H.H. expressed a concern about her financial situation with respect to the AAA repair. It is reasonable to not do studies that a physician does not feel are absolutely necessary. The patient's financial concerns are part of the pathology. On March 6, 1998, Patient H.H. was admitted to Winter Haven Hospital and filled out and signed the Special Authorization for Medical and/or Surgical Treatment form indicating her consent to the surgical procedure which Respondent was to perform. She indicated that she understood the risks associated with such surgical procedure. Paragraph two of the informed consent form states in pertinent part: I hereby certify that I have given complete and informed consent for the above named operation and/or procedures, and Dr. L. Thomas has explained to me the reason why the above-named operation and/or procedure are considered appropriate, its advantages and possible complication, if any, as well as possible alternative modes of treatment. I also certify that no guarantee or assurance has been made as to the results that may be obtained. The operative procedure on the consent form was signed by Patient H.H. at 6:10 a.m. on March 6, 1998. Surgery indicated on the consent form was for a resection abdominal aortic aneurysm (AAA repair). After Patient H.H. was taken to the operating room and administration of anesthesia began, Respondent performed his routine preoperative check of femoral and pedal pulses. Checking for femoral and pedal pulses is the type of preoperative work-up Respondent routinely performs while he waits for the anesthesia to take its effect on the patient. The operative report indicates that the abdominal aneurysm was "very large" extending quite high within 1-2 cm from the renal vein and down to and involving the common and hypogastric arteries and noted to be "quite saccular" with "impending rupture in the near future at the neck." The common iliacs were noted to be "quite large and aneurysmatic." The external iliacs were soft but extremely small, "approximately 4-5 mm in size, certainly less than half, more like 1/4 the size of a normal iliac" but nevertheless usable vessels to make his anastomosis. As Respondent was bluntly dissecting (separating the tissues using the fingers) the aortic aneurysm from the venous plexus to position his proximal clamp when one of the lumbar veins was encountered and mass bleeding occurred. The venous plexus is a grouping of veins located under the aorta that can best be described as a wagon wheel. The system has a hub and all the veins in the grouping extend outward from the hub. If one of the veins in the grouping is injured, it will bleed heavily, but the bleeding is controllable. The lumbar veins are part of the venous plexus and a tear of the lumbar vein is a known risk during this type of surgery. Patient H.H. suffered the loss of three times the amount of blood as would have been routinely expected. The sudden blood loss caused the patient's condition to rapidly deteriorate. Dr. Wickstrom-Hill, Anesthesiologist, testified that had Respondent not controlled the blood loss, and had not maintained Patient H.H.'s vital signs, she would have died. Using sound medical judgment, Respondent elected to bypass the aneurysmatic common iliacs and make his anastomosis of the graft to the external iliacs in order to not disconnect or separate the aortic or common iliac aneurysms from the iliac vein. This is a very fragile vessel and could have resulted in further massive bleeding and possible death of the patient. A reasonable prudent physician faced with a similar circumstance and situation would not attempt to mobilize the aneurysm further if doing so would cause additional massive blood loss and possible death of the patient. The hypogastric arteries (a/k/a the internal iliacs) serve to provide the pelvic viscera (bladder, rectum, etc.) with blood. During the AAA repair, Respondent performed an embolectomy on both legs following manipulation of the aneurysm. The purpose of this procedure was to remove any debris which may have dislodged from the aneurysm and flowed distally to the legs. The procedure involves running a Fogarty catheter down the femoral arteries as far as the catheter will go, then inflating a balloon located at the end of the catheter. Once the balloon is inflated, the surgeon will extract the catheter, pulling the debris out of the artery. This process is repeated as necessary to remove all debris. Fresh clot was obtained from both legs, indicating a lack of debris. Prior to completing the anastomosis of the bifurcated graft to the aorta and external iliacs respectively, Respondent ran a Fogarty catheter down proximal (back into the graft itself), to remove any debris in the graft itself. Finally, he back-bled the graft (allowed blood to flow out of the graft, to, again, ensure that there existed no debris in the graft). On March 7, 1998, Patient H.H.'s medical condition stabilized such that Respondent felt it safe to return Patient H.H. to the operating room to undergo an additional embolectomy of the legs and an endarterectomy of the right femoral artery. The record demonstrates that Respondent believed he collected embolic debris from the femoral arteries. However, based upon the pathology report and the testimony of Dr. Zeller, the debris removed from Patient H.H. during this procedure was acute blood clots and atherosclerotic plaque. This finding is consistent with thrombotic material and not a result of debris coming from another location as it tends to demonstrate that Patient H.H. had a clotting disorder consistent with her medical history. The record also demonstrates that upon completion of the procedure, Patient H.H. was noted to have excellent pulses in the superficial and profunda femoral arteries distal to the anastomosis with good emptying and filing of the vessels. Before, during, and after the AAA repair, Respondent used Heparin (an anti-clotting drug) in an effort to prevent the formation of clots throughout Patient H.H.'s vascular system. Intraoperatively, on March 3, 1998, Respondent administered 10,000 units of Heparin. Normally a patient will respond to 5,000 units. Despite giving Patient H.H. twice the normal amount of Heparin, Patient H.H. continued to have a lowered clotting time. It is noted in the medical record that Patient H.H. had an Antithrombin III deficiency. Antithrombin III is one of the factors that control how blood in the human body clots. Patient H.H.'s Antithrombin III deficiency is a hereditary defect that contributed significantly to her continued clotting despite the use of pharmacological intervention (substantial amount of Heparin). Respondent testified that in his medical training and experience, Patient H.H.'s Antithrombin III deficiency level was near fatal. Because Patient H.H. was hypercoagulative, thus causing the small vessels to clot off, on March 13, 1998, Patient H.H. underwent bilateral above the knee amputations. Hypercoagulopathy is a tendency to clot without anything being done - the blood just clots. This can be caused by a lower-than- normal blood pressure for a period of time and by having an Antithrombin III deficiency. Respondent observed during the surgery that this patient was hypercoagulative because he could see the blood clotting in the wound despite the fact that Patient H.H. was on twice the normal amount of Heparin. Respondent practiced within the standard of care at all times during the treatment of Patient H.H. Blood-flow going retrograde back into the common and iliac aneurismal sacs did not place Patient H.H. at a risk of rupture. The operative report clearly demonstrates that the aortic aneurysm involved the common iliacs and extended below the hypogastric arteries. The operative report also demonstrates that the external iliacs were extremely small, approximately one-quarter of the normal size. A reasonable and prudent surgeon, faced with a similarly situated patient with a massive sized aneurysm and the extremely small size of the distal external iliacs, would conclude that the pressure gradient now being carried to the graft rather than to the aneurysm would diminish flow to the aneurysms making the possibility of rupture unlikely. Moreover, the aneurysms were filled with calcified atherosclerotic plaque and other thrombotic (non-mobile) material. Dr. Begelman testified that calcified aneurysms do not tend to rupture as much. On direct examination, Dr. Begelman, Petitioner's expert, could not conclusively determine whether Respondent's surgical treatment of Patient H.H. fell below the standard of care and that distal clamping is an intra-operative decision to be made by the surgeon. Dr. Begelman who testified that he accepted Respondent's opinion that the iliacs were too large or too thin walled and could not distally clamp the aneurysm and that such decisions are those made by the surgeon on the case. Drs. Begelman and Seller and Respondent testified that it is usual and customary during this type of surgical procedure to distally clamp the aorta and that it is expected of a reasonable and prudent surgeon to make every attempt to do so. Nevertheless, all three doctors recognized that there are times when you cannot or should not distally clamp if to do so would cause further injury to the patient or death. Patient H.H. presented with very massive aneurysms of both the aorta and common iliacs making distal clamping impossible without sacrificing the hypogastric arteries thus placing Patient H.H. at risk for further injury or death. Petitioner's expert accepted Respondent's assessment of the condition of the iliacs and that Respondent did not want to dissect the iliacs off the iliac vein, which one needs to do in order to tie off distally. Dr. Begelman testified that he could not ascertain whether Respondent fell below the standard of care with respect to Respondent's treatment of Patient H.H. intraoperatively. Respondent acted within the standard of care and, therefore, did not violate Section 458.331(1)(t), Florida Statutes, when he did not clamp the distal arteries before manipulation of the aneurysm. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by sewing the bifurcated graft to the external iliacs and making no attempt to disconnect the aneurysm from the common and internal (a/k/a hypogastric) iliacs. The common and internal iliac tissues were also diseased because of their involvement with the aneurysms coupled with the fact that the aneurysm and surrounding tissue was inflamed. Inflammation causes the tissues of the surrounding viscera to become sticky and by that, stick together making separation difficult and more prone to bleeding on manipulation. Normally, the surgeon must bluntly dissect (lift up) the distal end of the aorta in order to place the distal clamps on the aorta below the aneurysm. However, the inflammation present in Patient H.H.'s aorta made it impossible to mobilize (lift up) the distal aorta for clamping because the tissue was stuck to the iliac vein which could have caused Patient H.H. to suffer a lethal blood loss. Normally, blood loss associated with this type of surgery amounts to 500 ccs for the total surgery. Patient H.H. lost 1500 ccs during the manipulation of the aortic aneurysm to place the proximal clamp and a total of 2400 ccs during the entire surgery which represented a blood loss of nearly 25-40 percent respectively of her estimated total blood volume. Respondent used sound medical judgment by making no attempt to dissect the common iliac from the subordinate tissue because, in his training and experience, the separation of tissues would have caused further, possible lethal bleeding. Drs. Begelman and Zeller, experts for Petitioner and Respondent respectively, testified that a reasonably prudent surgeon would not clamp below the common iliacs if to do so would sacrifice the hypogastric arteries and thereby cause irreparable harm or death to the patient. Dr. Zeller testified that the hypogastric arteries are of such importance that not clamping them, even at the risk of embolization, would nevertheless be within the standard of care. Respondent closely monitored Patient H.H. postoperatively. A reasonable and prudent surgeon is not expected to remain in the recovery room with his post-surgical patient until the patient becomes stable. Rather, the reasonable and prudent surgeon is expected to utilize the nursing staff who are charged with attending to the patient and to keep the physician updated on the patient's medical condition. Petitioner's witness, Doris Gutierrez, was the recovery room nurse on duty on March 6, 1998. Her duties included monitoring and reporting changes in Patient H.H.'s condition to Respondent. The record demonstrates that Respondent closely monitored Patient H.H. postoperatively by being in contact with the nursing staff and thereby giving orders for care and treatment to the nursing staff, either by telephone orders ("TO") or in person by verbal orders ("VO") to stabilize the patient. While in the recovery room, Patient H.H. was intubated, on a respirator. Petitioner's witnesses, Doris Gutierrez, confirmed Respondent's monitoring of Patient H.H. when she testified that she called Respondent several times to provide updates on Patient H.H.'s condition. The record demonstrates that postoperatively on March 6, 1998, Respondent wrote his initial order to the nursing staff at 12:30 p.m. while sitting in post-surgical recovery with Patient H.H. Thereafter, Respondent continued to monitor Patient H.H.'s condition and remained in communication with the nursing staff and wrote orders at 1:30 p.m., 2:30 p.m., 3:25 p.m., 5:00 p.m., 5:15 p.m., 8:15 p.m., and again on March 7, 1998 at 12:24 a.m. Following his TO on March 7, 1998, at 12:24 a.m., Respondent next saw Patient H.H. 7 1/2 hours later, at 8:00 a.m., prior to taking Patient H.H. to the surgery room to perform the endarterectomy and embolectomy. Ms. Gutierrez testified that she does not always note when the doctor comes back into the recovery room to give orders. She could not testify as to events that took place after Patient H.H. was transferred to the Surgical Intensive Care Unit ("SICU"). She also stated she did not know how many times Respondent went to SICU because she did not work in SICU when Patient H.H. was transferred out of the recovery room. Ms. Gutierrez was also unable to testify as to when the last time was that Respondent came to the recovery room. Respondent testified that there is a difference between a TO and a VO, the latter indicating that the physician was present in the room at the time he gave his order to the nurse. The evidence is not clear and convincing that Respondent did not provide appropriate postoperative monitoring of Patient H.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine: Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4406PL, and DOH Case No. 1994-12341. Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4407PL, and DOH Case No. 1999-57795. DONE AND ENTERED this 8th day of August, 2002, 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 8th day of August, 2002. COPIES FURNISHED: William R. Huseman, Esquire Romualdo C. Marquinez, Esquire Huseman, Marquinez & Schlegal, P.A. 6320 St. Augustine Road, Building 12 Jacksonville, Florida 32217 Kim Kluck, Esquire Richard J. Shoop, Esquire Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 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 Tallahassee, Florida 32399-1701
The Issue Whether Respondent, a physician, committed the offenses alleged in the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact At all times pertinent to this proceeding, Respondent was a licensed physician in the State of Florida (license number ME 0031217) who practiced in the specialty of orthopedic surgery. Respondent was not board certified. At all times pertinent to this proceeding, Respondent had hospital privileges at Palm Springs General Hospital (Palm Springs) in Hialeah, Florida. On Saturday, February 26, 1994, T. P., a 29 year-old male, suffered a badly fractured leg while playing soccer. T. P. was taken to the emergency room at Palm Springs where the emergency room physician partially reduced the angulation of the fracture and placed the patient's leg in a splint cast. The patient was thereafter admitted to Palm Springs on February 26, 1994, under the care of Dr. Stephen Ticktin, an orthopedic surgeon. X-rays revealed that the patient had sustained a jagged fracture of both the tibia and the fibula. The fractures were similar to sharp-edged spears. There was a laceration and significant bruising at the fracture sight. Dr. Ticktin examined the patient's leg on February 26, 1994, but did not reduce the fracture (set the leg) on that date. Instead, Dr. Ticktin kept the leg in the splint cast to immobilize it, and planned to perform surgery on the following Monday morning. The patient and his girlfriend told Dr. Ticktin that they did not want to have surgery at Palm Springs. They wanted the patient transferred to a Broward County hospital so that he could be closer to his residence. On Monday, February 28, 1994, Dr. Ticktin did not perform surgery on T. P. On Monday, February 28, 1994, T. P. changed his mind and agreed to have surgery at Palm Springs. (Dr. Ticktin's notes reflect that the patient changed his mind after talking to a representative of his insurance company.) Surgery was planned for Wednesday, March 2, 1994. On that Wednesday, the patient ran a fever. Because of that fever, the anesthesiologist cancelled the surgery that had been scheduled for March 2, 1994. The patient terminated the services of Dr. Ticktin on March 2, 1994, and refused to be treated by him. Late in the day of Wednesday, March 2, 1994, the hospital administrator asked Respondent to assume the care of the patient. Respondent first saw the patient between 10:00 p.m. and 11:00 p.m. on Wednesday, March 2, 1994. At the time Respondent first saw him, T. P. had been immobile with the cast that Dr. Ticktin had placed on his leg on February 26, 1994. His fractured leg had not been set. The patient was very upset. On the evening of March 2, 1994, Respondent determined that the fracture would have to be reduced with the patient being under general anesthesia. Respondent observed that the leg did not appear to be excessively swollen and that the circulation in the leg was appropriate. Respondent noted that there was numbness in the foot, which indicated that a peritoneal nerve had been injured. Respondent had no reason to believe that that the patient was suffering from a compartment syndrome on March 2, 1994. Compartment syndrome is a relatively rare occurrence that results in restricted or total loss of blood flow due to swelling within a compartment, which is an enclosed facia. The tibia and fibula are encased in a compartment from the knee to the ankle. Swelling within that compartment produces pressure on the arteries and smaller blood vessels that can restrict or completely block the flow of blood below the area of the swelling. It typically takes several hours or days for a compartment syndrome to manifest itself. On the morning of March 3, 1994, Respondent aligned T. P.'s leg, thereby reducing the fractures, and stabilized it by inserting pins in the leg and applying an external fixater attached above and below the fracture sites. At approximately 10:00 a.m. on March 3, 1994, the patient was moved from the operating room to the recovery room. At the time the patient left the operating room, there were no signs that anything untoward had happened. The recovery room records reflect that at approximately 10:05 a.m., there was no pulse below the fracture site. Respondent observed in the recovery room that the leg below the fracture was ischemic (receiving little or no oxygen). Respondent testified, credibly, that he considered whether the patient was suffering a compartment syndrome, but that he concluded that he probably was not because of the rapid onset of the problem following the reduction and the placing of the fixater, and because the leg remained supple and had not changed from the earlier examination. Respondent immediately ordered an angiogram, the appropriate diagnostic examination, and contacted Dr. Marcos Zequeira, a vascular surgeon on the staff of Palm Springs. Both Respondent and Dr. Zequeira were of the opinion that the patient had suffered a vascular accident and neither one formed the opinion that they were dealing with a compartment syndrome. Dr. Zequeira and Respondent agreed that an angiogram should be performed to diagnose the cause of the loss of blood flow in the leg. Dr. Zequeira advised Respondent that there were no facilities to perform an angiogram at Palm Springs. 1 Dr. Zequeira and Respondent decided to transfer the patient to Dr. Felix Freshwater, a micro-surgeon at Deering Hospital, to perform an angiogram and perform the procedure that would be necessary to resolve the problem. As soon as could be done, Dr. Zequeira contacted Dr. Freshwater, who agreed to accept the patient. Respondent thereafter immediately made the arrangements for an ambulance, which transported the patient to Deering Hospital. Respondent followed the ambulance in his own car and remained with the patient until after Dr. Freshwater performed surgery on the patient. The patient arrived at Deering Hospital at 2:00 p.m. and the angiogram was completed at 3:40 p.m. Anesthesia was started on the patient at 4:37 p.m. and surgery began at 5:30 p.m. The angiogram performed at Deering Hospital revealed that the patient had suffered a type of a compartment syndrome. It was not a typical compartment syndrome and it could not have been accurately diagnosed without the angiogram. Dr. Freshwater testified that his and Dr. Zequeira's presumptive diagnosis prior to the angiogram was that of a direct arterial injury as opposed to a compartment syndrome. Appropriate surgical intervention required an angiogram. The surgical procedure performed by Dr. Freshwater (fibulectomy-fasciotomy) restored the circulation in the patient's leg. Loss of blood flow presents a serious threat to a patient's leg and can result of the loss of the limb. The longer the blood flow is cut off, the more damage to the leg occurs. Damage can begin to occur in as little as two hours after the flow is cut off. Damage to the leg is certain if blood flow is cut off for twelve hours or longer. Here, the patient's circulation in his leg had been significantly restricted or blocked from approximately 10:05 a.m. until the surgical intervention by Dr. Freshwater. Petitioner did not establish that the patient's subsequent problems with his leg were attributable to that fact.2 Petitioner's experts opined that when he first detected that the blood flow in the leg had been compromised, Respondent should have immediately removed the fixater from the patient and, if necessary, displaced the fracture, thereby restoring the flow of blood. These witnesses, both of whom are highly qualified in their fields of practice, testified that Respondent's failure to take prompt action to restore the flow of blood was below the acceptable standard of care. Dr. Freshwater and Dr. Shall were of the opinion that Respondent did not practice below the standard of care. All experts agree that it was appropriate for Respondent to consult with Dr. Zequeira, a vascular surgeon, and to order an angiogram. All experts agree that the restricted or blocked blood flow presented a danger to the patient's leg, and all agreed that the leg would suffer more damage the longer it took to restore appropriate blood flow. Dr. Freshwater and Dr. Shall were of the opinion that removing the fixater and displacing the fractures as suggested by Petitioner's experts without an angiogram would have presented an unwarranted risk to the patient because an appropriate diagnosis had not been made (and could not have been made without an angiogram) and because moving these spear-like fractures could easily have resulted in more damage to the leg, such as cutting or puncturing an artery. The more persuasive evidence established that it was appropriate for the Respondent to transfer the patient to the care of Dr. Freshwater because Dr. Freshwater was imminently qualified to perform the delicate surgery that was thought necessary to restore the blood flow and because Deering Hospital had the facilities to perform the requisite angiogram. All of the treating physicians were aware that time was of the essence and they moved as expeditiously as circumstances and prudence permitted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against the Respondent be dismissed. DONE AND ENTERED this 11th day of February, 1999, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 11th day of February, 1999.
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
