The Issue The issue for consideration is whether Respondent, Sarasota County Public Hospital Board's, (Board), Motion To Dismiss HCA of Florida, Inc.'s (Doctors), Petition For Formal Administrative Proceedings should be granted.
Findings Of Fact On June 26, 1990, the Board filed CON application No. 6347, seeking approval to construct a comprehensive outpatient center and medical office complex on the campus of Sarasota Memorial Hospital. The new facility, anticipated to have a cost of slightly in excess of $18,000,000.00, was to house several outpatient functions including: outpatient registration outpatient diagnostic radiology outpatient laboratory services outpatient rehabilitative services outpatient cardiology diagnostic center outpatient dialysis Health resources center, and an office building located adjacent to the existing ambulatory surgical center. On or about July 13, 1990, the Department of Health and Rehabilitative Services, (Department), issued its State Agency Action Report, (SAAR), in which it indicated a preliminary decision to approve the subject application in its entirety, designating the project reviewable under Section 381.706(2)(d), Florida Statutes. Notice of this decision was published in the Florida Administrative Weekly on August 3, 1990. On August 14, 1990, Doctors filed a Petition For Formal Administrative Hearing challenging the preliminary approval, claiming that components of the project are reviewable under several subsections of Section 381.706(1), Florida Statutes. Specifically, Doctors claims that the operation of a home health agency from the complex renders it reviewable under subsection (f); that as the project constitutes a substantial change in the provision of inpatient services, or establishes new inpatient services, it is reviewable under subsection (h); and that it is an additional health care facility which is reviewable pursuant to subsection (b). Doctors also claims the new facility will hurt its ability to compete for patient referrals from physicians who will be housed in the new facility and will result in a reduction of Doctors' market share. Doctors is an existing hospital that provides a full range of acute care services to residents of Sarasota County. The Board's application contends that the development of this complex will free up capacity in key ancillary areas to better accommodate patients, and it is so found. The ambulatory diagnostic and treatment space proposed for the new facility represents what would have otherwise been less efficient additions to the existing departments. There will also be a bridge connecting the main hospital to the new center which will provide convenient access to any outpatient who may need to visit the hospital. It will also provide, "... direct linkage between the acute inpatient facility with the physicians' offices thereby enhancing pertinent access to a range of diagnostic and treatment services." Doctors contends in its Petition that it is the Board's clear intention and expectation to increase its service area and market share of Sarasota County patients as a result of this project. It asserts that if the Board's project is implemented, it will be serving different patients, and a different patient mix from a different geographical area than currently served. For the purpose of resolving the limited issues at this motion hearing, these assertions are accepted as fact. Accepting the assertions in paragraph 5 through 7, above, as fact, however, does not necessarily require the conclusions be reached that the accomplishment of the Board's project would result in any significant change to the level of its patient service since what is planned deals only with outpatient services. While Doctors disputes this, its claims that inpatient services would be effected is not supported.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore RECOMMENDED that the Secretary, Department of Health and Rehabilitative Services, enter a Final Order dismissing HCA of Florida, Inc.'s Petition in opposition to the grant of CON No. 6347 to the Sarasota County Public Hospital Board. RECOMMENDED this 15th day of October, 1990, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of October, 1990. COPIES FURNISHED: Robert A. Weiss, Esq. Parker, Hudson, Rainer & Dobbs The Perkins House 118 N. Gadsden Street Tallahassee, Florida 32301 John Radey, Esq. Elizabeth McArthur, Esq. Aurell, Radey, Hinkle & Thomas Suite 1000, 101 North Monroe Street Post Office Drawer 11307 Tallahassee, Florida 32302 Edward G. Labrador, Esq. Department of Health and Rehabilitative Services 2727 Mahan Drive, Suite 103 Tallahassee, Florida 32308
The Issue The issues in this case are whether the Respondent, Thandaveshwar Mysore, D.V.M., committed the violations alleged in an Administrative Complaint, DPBR Case Number 2005-005136, filed by the Petitioner Department of Business and Professional Regulation on October 19, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact The Parties. Petitioner, the Department of Business and Professional Regulation (hereinafter referred to as the "Department"), is the state agency charged with the duty to regulate the practice of veterinary medicine in Florida pursuant to Chapters 455 and 474, Florida Statutes. At the times material to this proceeding, Thandaveshwar Mysore, is and was a licensed Florida veterinarian, having been issued license number VM5191. Dr. Mysore has been licensed in Florida as a veterinarian for approximately 20 years. At the times material to this proceeding, Dr. Mysore’s address of record was 8904 North Military Trail, Palm Beach, Florida 33410. Dr. Mysore obtained his veterinary degree in 1957. He taught veterinary medicine as an associate and assistant professor for approximately 19 years prior to moving to the United States. He has published more than 50 articles in veterinary journals. At the times relevant to this matter, Dr. Mysore’s practice was exclusively small animals, primarily dogs and cats. He has successfully performed thousands of spays on dogs and cats without incident. Dr. Mysore’s Treatment of Ricochet. On October 13, 2004, Rita Gurskin took her nine-month old female dog “Ricochet” and three other animals to be spayed and/or neutered by Dr. Mysore. Having examined Ricochet, Dr. Mysore sedated her pursuant to his normal protocol and performed a routine surgical spay. Ricky Joe King, who has assisted Dr. Mysore on a number of occasions, witnessed the procedure. The surgical area was cleaned by Dr. Mysore with Betadine and alcohol. Mr. King has been present and assisted Dr. Mysore in between 70 to 100 spay procedures. He has some understanding of the need to ensure that a surgical area is free of debris, and, in particular, hair. Both Dr. Mysore and Mr. King believed that the surgical area on Ricochet had been properly cleaned and prepared. Neither noticed any hair inside the incision in Ricochet at any time prior to or during closure of the incision. Following the procedure, Ms. Gruskin came to Dr. Mysore’s office to pick up Ricochet. While the testimony concerning Ricochet’s condition at that time conflicted, the more convincing testimony was that of Ms. Gruskin. According to Ms. Gruskin, Ricochet was lethargic and had to be assisted out of the office. While taking Ricochet to her vehicle Ms. Gruskin noticed what she believed was blood oozing from the incision. She pointed this out to Dr. Mysore, who assured her it was normal and told her not to worry about it. Dr. Brinkman’s Treatment of Ricochet. Following the October 13th surgical procedure, Ricochet was lethargic and had little appetite. The incision was inflamed and oozed blood and puss. Concerned about Ricochet’s condition, Ms. Gruskin took the dog to her regular veterinarian, Ted Brinkman, D.V.M., on October 15, 2004. Dr. Brinkman examined Ricochet. Ricochet’s temperature was 103.6F, she had an elevated white blood count, and the area around the incision area was swollen. Dr. Brinkman concluded that the incision would need to be repaired but that, because Ricochet’s condition was not critical and she had only recently undergone the surgery, recommended that no surgery be performed on Ricochet at that time. Ms. Gruskin agreed and Dr. Brinkman began a treatment with antibiotics. Ms. Gruskin returned to Dr. Brinkman’s office with Ricochet on October 22, 2004. Ricochet’s condition had not improved. Her white cell count had risen and the incision area was swollen and puffy. Dr. Brinkman recommended surgery, which Ms. Gruskin agreed to. As Dr. Brinkman began to open the incision, he found that the skin on the sides of the incision was not healing edge to edge. The skin had rolled in on itself and Dr. Brinkman was able to pull the incision apart easily. This was a result of the incision not having been property closed. The area of the incision had swollen to the size of a grapefruit. After opening the incision site, Dr. Brinkman found a “huge seroma of pussy infected nasty tissue.” There was also a “huge strange looking nest of hair” which consisted of hundreds of loose hairs inside the incision. According to Dr. Brinkman, there was a dead space in Ricochet which was filled with serum, the area was infected and raw looking, and was “hamburger like.” Dr. Brinkman removed the mass of hair and the infected, necrotic tissue and closed the incision. On November 11, 2004, Dr. Brinkman’s sutures were removed and Ricochet was discharged from Dr. Brinkman’s care. Ricochet made an uneventful recovery from the surgery performed by Dr. Brinkman. Ultimate Findings. While no one witnessed precisely how the hairs found by Dr. Brinkman when he opened Ricochet’s incision ended up inside Ricochet, the only logical conclusion that can be reached under the facts of this case is that the hairs were left in the site when Dr. Mysore performed the spay on Ricochet on October 13, 2004, and, unnoticed by Dr. Mysore or Mr. King, left inside the surgery site when it was sutured. There simply is no other plausible explanation. Admittedly, Dr. Mysore performed surgery on Ricochet. At the conclusion of that surgery, Dr. Mysore closed upon the surgery site. While neither Dr. Mysore nor Mr. King saw any hair in the open wound, Ricochet was covered with a drape which could have easily have blocked their view or they simply did not look closely. Just because they did not see the hair, does not mean that it was not there. Once the incision had been sutured by Dr. Mysore, the evidence failed to prove that the amount of hair found by Dr. Brinkman could have gotten into the surgery site in any other manner than by having been left in the site before the incision was sutured. The foregoing findings are further supported by Dr. Greene’s opinion testimony as to the likely circumstances under which the hairs could have gotten between Ricochet’s abdominal muscles and skin. It is also found that the tissue discovered by Dr. Brinkman inside the incision cavity was necrotic tissue and that it occurred as a direct result of the surgery performed by Dr. Mysore. This finding is based upon the opinion testimony of Dr. Greene, which was premised upon Dr. Brinkman’s credible description of the tissue he found inside Ricochet when he performed his surgical procedure. The necrotic tissue found by Dr. Brinkman was caused by the presence of the hair left inside the incision by Dr. Mysore. Again, this is the only plausible explanation for the “hamburger like” tissue found by Dr. Brinkman. Dr. Mysore’s Medical Records. Dr. Mysore failed to record the breed and species of Ricochet in the “heading” of the “Examination Records” he maintained on Ricochet. It was noted, however, that Ricochet was a “dog” in the body of those records. Ricochet was also identified by species and breed (although not with consistency) in the Surgery Authorization form for Ricochet’s surgery and on receipts of payment for services. Dr. Mysore also failed to record Ricochet’s temperature in his medical records. Although, if Ricochet’s temperature had been within the normal range, his failure to record her temperature would not have caused any “damage per se,” taking the temperature of an animal and recording it are a normal part of the required physical examination of the animal, which in turn is required to be included in an animal’s medical records. During Ricochet’s surgery, she was administered the drugs Atropine and Acepromozine. Dr. Mysore noted in Ricochet’s medical records that the drugs were given and recorded the amount given for both drugs combined (3cc’s). Dr. Mysore did not describe in the medical records the amount of the individual dosages of the two drugs given to Ricochet. Dr. Mysore has suggested that by using the Compendium of Veterinarian Products, which essentially lists drugs used by veterinarians and describes what is in the “package insert” for the drug, it can be determined how much Atropine was administered to Ricochet and that amount can then be subtracted from the total drugs given to determine the amount of Acepromozine. Although there are different strengths of Atropine, the dosage for any strength suggested for use on dogs is the same: 1 mL for each 20 lbs. of body weight. Therefore, knowing Ricochets’ body weight (49 lbs.), it can be determined how much of the 3 cc injection of drugs was Atrophine. This amount can then be subtracted from the total to determine the amount of Acepromozine administered. The difficulty with Dr. Mysore’s argument is two-fold. First, it cannot be determine from the medical records that Dr. Mysore even relied upon the Compendium. Without this information, there is no way to know to apply the calculation suggested by Dr. Mysore. Although many veterinarians rely upon the information contained in the Compendium, not all do, and, therefore, there would be no reason to assume that Dr. Mysore did in this matter. Secondly, although veterinarians may rely generally upon information contained in the Compendium, there is no requirement that a veterinarian strictly adhere to the suggested dosages information contained therein. Therefore, even it were assumed in this matter that Dr. Mysore referred to the suggested dosage for Atropine contained in the Compendium, it cannot be assumed that he followed the suggestion.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board enter a final order finding that Thandaveshwar Mysore, D.V.M., committed the violations described in this Recommended Order, placing his license to practice veterinary medicine on probation for a period of one year, and requiring that he pay a fine of $2,500.00, and the costs of the investigation of this matter, within 30 days of the entry of the final order. DONE AND ENTERED this 12th day of January, 2009, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 12th day of January, 2009. COPIES FURNISHED: Martin P. McDonnell, Esquire Rutledge, Ecenia, Purnell & Hoffman, P.A. Post Office Box 551 Tallahassee, Florida 32302 Charles Tunnicliff, Esquire Department of Business & Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-2202 Elizabeth F. Duffy, Esquire Department of Business and Professional Regulation 1940 North Monroe Street, Suite 42 Tallahassee, Florida 32399-2202 Juanita Chastain, Executive Director Board of Veterinary Medicine Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Ned Luczynski, General Counsel Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violations set forth in the Administrative Complaint.
Findings Of Fact Petitioner, Department of Health, Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Respondent, Santo S. Bifulco, M.D. (Respondent), is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued License Number ME 0056868 on February 13, 1990. He has been continuously licensed since February 1990 and has never been disciplined by the Board of Medicine. Respondent, a physiatrist, specializes in physical medicine and rehabilitation. He entered private practice immediately after completing a four-year residency program in physical medicine and rehabilitation. During his residency, Respondent learned and performed electrodiagnostic and neurodiagnostic tests. He was trained in the use of videofluoroscopy, electroencephalogram, needle and surface electromyography, nerve conduction studies, and other electrodiagnostic tests. Respondent performed far above the minimum 200 required for successful completion of the residency program. As a part of his residency, Respondent also had the opportunity to observe and work with chiropractic physicians from the local chiropractic medical school, thereby allowing him to understand the role of chiropractic care and allopathic medicine in the treatment of a patient. Respondent first saw E. C. on December 9, 1991. At the time, he had been practicing physical medicine and rehabilitation for a little more than a year since completion of his residency program. Prior to coming under the care of Respondent, E. C. had been involved in a motor vehicle accident on August 9, 1991. The patient had been treated by both her family physician, Dr. George Harris, and her chiropractic physician, Dr. Richard Thomas, D.C., for the injuries which resulted from the accident. Dr. Harris prescribed medications for E. C. and Dr. Thomas provided and was continuing to provide several modalities for E. C.'s injuries resulting from her motor vehicle accident. Despite ongoing treatment by Dr. Thomas, E. C. was not significantly improving. Because E. C. was not improving under his care, Dr. Thomas referred her to Respondent. The purpose of the referral was for consultation and a second opinion. Respondent was also asked to determine what, if any, medications should be given to the patient and to provide them to the patient if it were appropriate. Respondent was not asked to nor did he assume direct primary care for the patient. Rather, Respondent's role was to provide Dr. Thomas with guidance as to the diagnosis and treatment direction for E. C. In his written report dated November 25, 1991, Dr. Thomas indicated that he was referring the patient to Respondent for further evaluation and for medication that might assist in the improvement of her symptoms. He noted that he would continue to provide palliative care to E. C. until such time as Respondent evaluated her and he had received Respondent's report and recommendation. When E. C. first came under Respondent's care, it was four months after the accident. However, her overall condition had not significantly improved. She had constant headaches, which were extreme and associated with dizziness, a history of high blood pressure, constant cervical pain radiating into her arms, thoracic pain or pain between the shoulder blades, numbness and tingling, and was limited in her physical activities. The pain was interfering with all aspects of her life, including her ability to work and sleep. Respondent performed a physical examination of E. C. on December 9, 1991. On physical examination, Respondent found that E. C.'s neck range of motion was markedly limited and associated with pain; that her lower back range of motion was markedly limited and associated with pain; and that she had positive findings on orthopedic examination, as well as, on neurologic examination. From Respondent’s examination, it appeared that E. C. had suffered injuries from the motor vehicle accident. Moreover, Respondent determined that E. C. was in need of continuing care and because she had not improved, was also in need of further diagnostic studies to evaluate the extent and nature of her injuries and her complaints. E. C. presented as a complicated case due to the length of time that had passed since the motor vehicle accident and the lingering and persistent complaints experienced by E. C. associated with that accident. Respondent’s impression was that E. C. had post- traumatic headaches and injuries to the soft tissues of the neck with radiating pain. Respondent believed that E. C. was involved in what is commonly known as a medical/legal case. Consistent with this belief, Respondent reasonably concluded that his role was to thoroughly evaluate E. C.'s condition by addressing and objectively documenting answers to the questions relative to the cause, extent, and nature of her injuries. Respondent obtained Dr. Thomas’ records to evaluate the care E. C. had been receiving and reviewed E. C.'s X-rays with her on her first visit. Based on his review of the records and his examination of E. C., Respondent believed that the care provided by Dr. Thomas was appropriate for E. C.'s condition and that she would benefit from continued conservative care. However, Respondent felt that for E. C. to reach her maximum potential, additional diagnostic tests could reasonably assist him in arriving at a diagnosis and recommendation for treatment of the patient’s condition. Respondent initially recommended that E. C. undergo diagnostic testing or studies including: nerve conduction studies; a Dermatomal Somatosensory Evoked Potential (DSEP); an electroencephalogram (EEG); a cervical Magnetic Resonance Imaging (MRI); and cinefluoroscopy or videofluoroscopy studies of the cervical spine. These tests were ordered and/or recommended because Respondent reasonably believed that they could assist him in determining the nature and extent of E. C.'s injuries and complaints and arriving at a recommendation for treatment. E. C. subsequently underwent the recommended testing. To assess the discs and other cervical soft tissues, Respondent recommended that E. C. receive imaging studies. Respondent recommended an MRI study of the cervical spine. This study was conducted on December 19, 1991, at the Access Imaging Center. The purpose of the MRI was to evaluate whether E. C. was suffering from a condition that could be treated by surgery. An MRI is a static exam and is the "gold standard" in looking for a herniated disc. E. C.'s MRI was normal, thus, ruling out the possibility of the need for surgical treatment of her condition. To assess ligamentous structures and capsular stability, Respondent also recommended that E. C. receive a videofluoroscopy of the cervical spine or dynamic motion studies. The videofluoroscopy was obtained on December 11, 1991, and was performed at the Tampa Bay Dynamic Imaging Center. The videofluoroscopy was the only test available to observe the movement of the cervical spine through a full range of motion versus the limited views obtained in extension and flexion X-rays, where the patient's neck is seen in a fully extended position, neutral position, and fully flexed position. In E. C.'s case, videofluoroscopy served to confirm the presence of a soft tissue injury. The videofluoroscopy exam revealed hypomobility of the cervical spine at the level of C5-6 and C6-7. This result was consistent with the extension and flexion X-rays of E. C. that had been taken while she was under Dr. Thomas' care. However, Respondent felt the videofluoroscopy was an appropriate diagnostic tool to determine if E. C. had deteriorated since her last exam or had greater instability than was thought to be present from review of the static flexion/extension films. The videofluoroscopy and the MRI allowed Respondent to determine the extent and nature of the patient’s injuries and make recommendations for continuing treatment to her primary physician, Dr. Thomas. Both imaging tests provided useful information in the diagnosis and treatment of the patient’s condition. E. C., who worked as a florist, was experiencing problems working, lifting, and performing many routine activities in her daily life. Because E. C. was not progressing in treatment, Respondent wanted an objective assessment of her strength and ability to lift. Respondent believed that this information would help guide E. C. and Dr. Thomas in advising the patient concerning what she should or should not be lifting. To accomplish this objective, Respondent ordered a N.I.O.S.H. lift test and a Range of Motion test. These tests were performed on December 19, 1991, in Respondent's office. The N.I.O.S.H. lift and Range of Motion tests are components of a battery of tests that make up what is commonly known as a functional capacity evaluation. A functional capacity evaluation is an extensive series of tests to determine a patient’s ability to return to work. By itself, a N.I.O.S.H. lift test is not a functional capacity evaluation and was never intended to be used in that manner by Respondent. Though E. C. had not significantly improved under Dr. Thomas' care, it appeared to Respondent that she had reached a plateau in that her condition was not improving. The N.I.O.S.H. test is appropriate when a patient like E. C. has reached a plateau in her care and is not progressing. It gives the physician information from which to base recommendations on the scope and nature of the activities in which the patient may participate. Furthermore, it helps the physician in designing a strengthening program appropriate to the patient’s physical limitations. It can also provide a baseline for future tests and serial evaluations of the patient’s progress. Respondent was unable to make use of the results from the N.I.O.S.H. test or obtain comparison tests because E. C. failed to return to his office after February 1992. To assess the presence or absence and the extent of any neurologic dysfunction in the upper extremities, Respondent recommended that the patient undergo nerve conduction studies. E. C. underwent those studies on December 30, 1991, in Respondent's office. The purpose of nerve conduction studies is to objectively evaluate peripheral nerve function. It is an average measure of the time it takes an electrical nerve impulse to travel down a segment of the nerve from the spinal column to a particular muscle group. It also includes a measure of the time it takes an electrical nerve impulse to travel from the point of stimulation up to the brain and back. Respondent’s use of nerve conduction studies to objectively look for pathology of the spine or peripheral nerves was warranted given her continued complaints and failure to improve after four months of conservative care. The nerve conduction studies were interpreted by Respondent as abnormal. However, many physicians would have interpreted the studies as normal because, in part, the latency was less than 30 and the difference was less than three milliseconds when compared to both sides. Nonetheless, it is also recognized that these interpretations are judgment calls by physicians based on several factors. To differentiate between problems with the peripheral nerves from those in the central nervous system, Respondent also recommended a DSEP of the upper extremities. This study was conducted on December 30, 1991, in Respondent's office. The DSEP was a companion exam to the nerve conduction studies and supplemented information learned from those studies. The combined exams assisted Respondent with localization of the source of the patient’s complaints and it was appropriate for the Respondent to have obtained both studies. In 1991, the use of the DSEP was relatively new, but it was a test that held out promise to physicians in helping them objectively quantify the functioning of nerves in all of their segments. Over time, it has been found that the DSEP does not provide any greater information than that gained by use of electromyography combined with imaging studies. However, in 1991, the thinking was different. In addition to the nerve conduction studies and the DSEP, Respondent recommended that E. C. undergo a standard awake or EEG. This test was performed on December 30, 1991, in Respondent's office. The purpose of the EEG was to evaluate the source of the patient’s continued complaints of headaches and of difficulty with sleeping. According to E. C., these problems had persisted for four months. The EEG was an inexpensive tool to evaluate whether E. C. was suffering from an intracranial bleed or from some other pathologic condition unrelated to her soft tissue injuries. Given the intensity and persistence of the headaches, Respondent felt that there was the possibility of trauma having gone undetected; he believed that such trauma could not be ruled out even though the patient had not related a history of having hit her head during the motor vehicle accident. The EEG came back as a normal study, thus, allowing Respondent to rule out more serious causes for the E. C.’s headaches. The results of the diagnostic tests allowed the Respondent to report to her primary treating physician his conclusions concerning the extent of the care to be provided, prescribe medications for E. C., identify the distribution of ligamentous instability, the etiology of her complaints, and her safe lifting capacities. It allowed him to rule out the possibilities of serious intracranial lesion and serious neurologic abnormalities. The data was suggestive of a problem in the thoracic outlet. In February 1992, E. C. returned to Respondent for re- evaluation and discussion concerning her medications. She was still experiencing headaches and was reporting that Dr. Thomas’ care was helping but she was unsure if her overall condition was improving. E. C. also reported a new problem with a burning sensation in the right foot at night, which Respondent had not assessed to be problematic. During this visit, Respondent altered her medications and scheduled her for surface electromyography exam (EMG) of the face and neck. The EMG was performed on February 28, 1992, in Respondent's office. The purpose of the surface EMG was to objectively evaluate whether E. C. had muscle spasms, and if so, the degree, interest and location of the spasms. The surface EMG also confirmed the clinical finding of muscle spasms. From the information gained from the study, Respondent could also objectively assess E. C.’s response to existing treatment and her need for further treatment including potential adjustments to be made to her medications in type and quantity. In 1991 and 1992, the results obtained from the surface EMG were thought to be important in providing care to patients or evaluating the treatment being provided. However, over time, it has been learned that muscle spasm can vary on a daily basis and, thus, the data obtained from the surface EMG may not be the best indicator as to how the patient is progressing in treatment. As physicians have learned more about the usefulness of surface EMG, they have come to rely upon it in biofeedback training. The exam provides the patient with an objective visual representation of muscle spasm, which then allows the clinician to teach the patient to relax the affected area. In E. C.’s case, the surface electromyography allowed Respondent to identify areas of muscle spasm for the purpose of planning her continued care. His use of the test in this manner, given the time period in which it was administered, was not inappropriate. E. C. left Respondent’s care after February 28, 1992, and subsequently came under the care of a neurologist, Dr. Alan Spiegel. Dr. Spiegel, who assisted in the treatment of the patient after she left Respondent’s care, did not have any criticisms of the care she had received from her prior treating physicians. As he formulated his treatment plan, Dr. Spiegel had the benefit of the records from E. C.'s prior physicians, including Respondent’s records. While receiving treatment from Dr. Spiegel, E. C. was still under the care of Dr. Thomas. Dr. Thomas’ role was to provide physical therapy while Dr. Spiegel provided medications to reduce inflammation and spasm. In fact, because she had received prior diagnostic exams, there was no need for Dr. Spiegel to perform any additional tests. Dr. Spiegel placed E. C. at maximum medical improvement on April 20, 1992, and found that there was a significant impairment of her physical condition. She experienced an exacerbation of her condition, received additional treatment, and was again placed at maximum medical improvement on October 9, 1992. At the time of the formal hearing, E. C. was still suffering from the injuries sustained in the motor vehicle accident of August 9, 1991. She continues to experience flare- ups of her condition and continues to receive treatment for her condition. Respondent's use of the diagnostic tests was not exploitative and was medically indicated at the time they were ordered. Respondent’s use of diagnostic tests was reasonably calculated to assist him in reaching a diagnosis and in making recommendations for continued treatment to her primary physician, Dr. Thomas. The tests were also used by her subsequent treating physicians in rendering care to the patient. This avoided the necessity of having the patient undergo further testing. As with many new practitioners, Respondent ordered more diagnostic tests than a more experienced practitioner might have thought necessary under the same circumstances. Moreover, since Respondent was fairly new in the practice, it was not unreasonable for him to have ordered more diagnostic exams than a more experienced practitioner might have ordered under similar conditions and circumstances. However, the fact that Respondent ordered more tests than a more experienced practitioner does not mean that the tests he obtained were not reasonably calculated to assist him in arriving at a diagnosis and recommendation for treatment of E. C.'s condition. Nor do more tests mean that they were not medically indicated. Several practitioners testified at the hearing and in their depositions that the tests were appropriate, particularly in 1991. Reasonable practitioners will differ as to the number and type of tests they will order to arrive at a diagnosis and treatment of a patient’s condition. At the formal hearing and in the written reports submitted into evidence, the opinions of seven physiatrists (Respondent, Dr. Gerber, Dr. Goodgold, Dr. Kelley, Dr. Krimshtein, Dr. Lichtblau, and Dr. Narula), a neurologist (Dr. Spiegel), a psychiatrist (Dr. Sprehe), and a neurosurgeon (Dr. Meriwether) were offered by the parties. Each of the physicians had a different belief as to the tests that he would order to evaluate E. C.'s condition. The Department provides appropriate and comprehensive training to members of the Board of Medicine as required by Section 458.307(4), Florida Statutes. At all times relevant to this proceeding, such training was provided to Board members when they were initially appointed as well as periodically throughout their tenure on the Board. Various methods utilized to implement and accomplish the required training included the following: viewing of appropriate videotapes; attendance at seminars and retreats; regular presentations at Board meetings; and dissemination of newsletters.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order in this case dismissing all charges against Respondent. DONE AND ENTERED this 7th day of July, 1999, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 7th day of July, 1999. COPIES FURNISHED: John E. Terrel, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Grover Freeman, Esquire Jon M. Pellett, Esquire 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
The Issue The issue in this case is whether the Petitioner's application for certification by examination as a basic X-ray machine operator should be approved or denied.
Findings Of Fact In February 2009, the Petitioner submitted an application to the Respondent for certification by examination as a basic X-ray machine operator. The application was submitted by “Ultimate Medical Academy” (UMA), where the Petitioner obtained his basic X-ray training, but the Petitioner provided the information contained therein and was responsible for the accuracy of the application. On the Petitioner’s application, he stated that he was employed in “basic x-ray” at Palm Harbor MRI, and indicated that “100%” of his time at Palm Harbor MRI was related to duties other than radiography, nuclear medicine, or radiation therapy. On February 19, 2009, the Respondent notified the Petitioner that the application was incomplete because it lacked a criminal history record from the Florida Department of Law Enforcement. On April 14, 2009, the Respondent received the Petitioner’s criminal history record, which revealed convictions between the years 1993 and 2002, and related periods of incarceration, for retail theft, felony grand theft, felony uttering of forged checks, other forgeries, and failure to appear. The Petitioner was also convicted of federal crimes, including possession of counterfeited checks in 2000 and felony uttering a forged check in 2002. The Petitioner spent three years in federal prison and, in December of 2003, was transferred to a halfway house after his release. His most recent sentence included a probationary period that expired at the end of May of 2007. As part of the application process, the Petitioner advised the Respondent that his civil rights had been restored on January 31, 2008. The Petitioner provided documentation to the Respondent that spelled his first name as “Erin.” For purposes of this Recommended Order, the restoration of civil rights has been deemed applicable to the Petitioner. The Respondent reviewed the Petitioner’s application, including the criminal history and the restoration of civil rights, and denied the application because of the Petitioner’s criminal history. The specific basis for the denial was the Respondent’s concern with the access an X-ray operator has to the personal belongings and medications of a patient while X-ray images are obtained, as well as to the personal and medical information contained within patient records. After receiving the Respondent’s decision, the Petitioner requested an administrative hearing to challenge the denial. After issuing the initial Notice of Intent to Deny, the Respondent became aware of potential issues related to the Petitioner’s employment during and after his training at UMA. As part of his educational training, UMA placed the Petitioner into an externship at Palm Harbor MRI for a six-week period of clinical practice. The externship ended on April 4, 2008, when he graduated from the UMA. The quality of the Petitioner’s job performance at Palm Harbor MRI is not at issue in this proceeding. There is no evidence that he was not competent to perform the tasks assigned to him during the externship. On April 9, 2008, the Petitioner began working as a full-time employee at Palm Harbor MRI. He performed some customer contact duties, greeting patients and gathering information. His duties also included placing and positioning patients on the X-ray table, imputing the machine settings (“technique”) and operating the X-ray machine, including the administration of radiation to obtain the desired images. Positioning patients for X-rays, machine technique, and operating the radiation equipment constitutes the practice of radiologic technology. The Petitioner was supervised by a licensed technician at all times during his positioning of patients and operation of the machine. The Petitioner performed these duties without being properly licensed. After the Respondent learned of the Petitioner’s job responsibilities at Palm Harbor MRI, the Respondent issued an Amended Notice of Intent to Deny that identified the alleged unlicensed activity as an additional basis for denial of the application. The Respondent also initiated a review of the Palm Harbor MRI facility’s operating procedures that was continuing at the time of the hearing. The application information originally disclosed by the Petitioner was inaccurate because it failed to reveal that he was involved in performing radiography at Palm Harbor MRI. In May 2009, the office manager at Palm Harbor MRI requested that the Petitioner provide a copy of his certificate, apparently unaware that the Petitioner had no license at that time. When he was unable to provide the certificate, his employment was terminated on May 18, 2009. The Petitioner has asserted that he was exempt from licensure because he was a student attending St. Petersburg College (SPC) with the intention of being admitted to the SPC radiologic technology program, and ultimately to become licensed as a radiography technologist. Students attending a medical school or “enrolled in and attending” a radiologic technology educational program are statutorily exempt from licensure during their educational period; however, there is no evidence that UMA students are entitled to the exemption. Although SPC has a radiologic technology educational program, the Petitioner has neither been admitted to the program nor attended any classes within the program’s curriculum. Additionally, Palm Harbor MRI is not an approved clinical training site for students enrolled in and attending the SPC radiography program. The Petitioner had not applied to the SPC radiography program prior to termination of his employment from Palm Harbor MRI, and the applications subsequently submitted by the Petitioner for application to the SPC radiography program were denied. There was no credible evidence presented at the hearing that the Petitioner was a medical student or was enrolled in and attending a radiologic technology educational program at any time relevant to this proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order denying the Petitioner's application for certification by examination as a basic X-ray machine operator. DONE AND ENTERED this 29th day of December, 2009, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 29th day of December, 2009. COPIES FURNISHED: Donna Erlich, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 C. Erica White, Esquire Quintairos, Prieto, Wood & Boyer, P.A. 215 South Monroe Street, Suite 510 Tallahassee, Florida 32301 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
The Issue Whether Petitioner's proposed treatment, fluoroscopic radiofrequency thermoneurolysis, is experimental.
Findings Of Fact Petitioner, Douglas J. Phillips, Jr., D.D.S. (Dr. Phillips), is a licensed dentist in the State of Florida. Sometime in January, 1993, Dr. Phillips proposed using the procedure, fluoroscopic radiofrequency thermoneurolysis to treat a patient. This procedure involves destruction of tissue by the application of high heat, at approximately two hundred degrees Fahrenheit. A probe or cannula (insulated needle) is placed through skin, subcutaneous tissue and muscle to reach into where the tendon or ligament inserts to the bone or to where there is a small nerve root. An electrode goes through the insulated needle. Heat is then applied at approximately two hundred degrees. The treatment causes a small scar on the bone or destroys the nerve. The purpose of the procedure is to treat head and facial pain. The patient has been diagnosed with the degeneration of the temporomandibular joint on the left side, advanced degenerative osteoarthritis, and fibrous ankylosis with osteroarthritis of the left temporomandibular joint. She experiences head and facial pain. Dr. Phillips had performed fluoroscopic radiofrequency thermoneurolysis on the patient in September, 1991. CIGNA approved and paid for the procedure. The patient experienced relief from the pain for almost two years after the procedure was done. The patient is now experiencing pain again, and Dr. Phillips proposes to treat her again with fluoroscopic radiofrequency thermoneurolysis. By letter dated January 29, 1993, Intervenor CIGNA, informed Dr. Phillips that his request to perform the proposed treatment was not authorized. CIGNA'S basis for denial of approval was that the procedure was experimental and was not recognized by the American Dental Association. On or about August 27, 1993, Dr. Phillips requested that Respondent, the Department of Labor and Employment Security, Division of Workers' Compensation (Division), review the procedure pursuant to Section 440.13(1)(d), Florida Statutes (1993) and Rule 38F-7.0201, Florida Administrative Code. On November 22, 1993, the Division issued a determination that fluoroscopic radiofrequency thermoneurolysis was experimental. Dr. Phillips was taught the proposed procedure eight years ago by Dr. Ernst, a dental practitioner in Alabama. Dr. Phillips spent four days observing Dr. Ernst in Dr. Ernst's office and one week of training in a hospital under the direction of Dr. Ernst. The first procedure performed by Dr. Phillips was two years after his training with Dr. Ernst. Prior to performing the procedure, Dr. Phillips also attended a one hour lecture on the procedure given by another dentist. No other dentist in Florida practices this procedure. The American Dental Association has not endorsed the procedure. Radiofrequency thermoneurolysis is not on the American Dental Association's list of approved dental therapeutic modalities. It is not taught in any dental school or school of oral surgery. Dr. Phillips is not aware of any mention of the proposed procedure in any dental or oral surgical textbooks. Only four other dentists in the United States practice this procedure. There is no published written protocol regarding this procedure except for an article written by Dr. Wilk, which consists of a two paragraph treatment of the subject. Fluoroscopic radiofrequency thermoneurolysis is not listed in the American Dental Association's Current Dental Terminology, nor does the proposed treatment have a code assigned to it. Donna M. Reynolds is a supervisor of the policy section in the Rehabilitation and Medical Services Unit of the Division. When she received the request from Dr. Phillips to review the proposed procedure, she contacted three consultants for the Division: Dr. Richard Joseph, Dr. Martin Lebowitz and Dr. Davis. She received responses from Drs. Joseph and Lebowitz indicating that they considered the procedure to be experimental. Dr. Davis did not respond to her request. Dr. Joseph is a board certified oral and maxillofacial surgeon. When asked by the Division to review the proposed treatment, he reviewed all the documentation submitted by the Division, which included the documentation that Dr. Phillips had submitted in support of his request. Dr. Joseph also did a medline search. Medline is a computerized medical library search that is commonly performed by physicians to research or review all of the current medical literature. The medline search of 301,000 articles revealed only two or three articles relating to the use of radiofrequency thermoneurolysis. Dr. Joseph also consulted with Dr. Gremillion, the chairman of the Department of Facial Pain at the University of Florida, College of Dentistry. Based on his research, Dr. Joseph opined that the proposed procedure was experimental. It was Dr. Joseph's opinion that radiofrequency thermoneurolysis was outside the practice parameters in the general practice of dentistry. Dr. Lebowitz, an oral and maxillofacial surgeon and former co-director of the Facial Pain Clinic at the University of Florida, reviewed the documentation sent by the Division with its request to review the proposed treatment. The documentation included articles which had been supplied by Dr. Phillips to the Division. It was Dr. Lebowitz's opinion that none of the articles submitted by Dr. Phillips were scientifically acceptable based on the lack of blind studies, the quantity of patients being studied, and the lack of studies performed in different locations. In researching the issue, Dr. Lebowitz contacted Dr. Jim Ruskin, the head of the residency program in the Oral Maxillofacial Surgery Department at the College of Dentistry, University of Florida. Dr. Ruskin is considered a world authority on the management of facial pain. Dr. Lebowitz also spoke with Dr. John Gregg, a Virginia dental practitioner who previously ran the facial pain clinic at Chapel Hill at the University of North Carolina. Additionally, Dr. Lebowitz spoke with Dr. Castellano, an oral and maxillofacial surgeon in Tampa, Florida. Based on his research, Dr. Lebowitz concluded that radiofrequency thermoneurolysis was experimental. Dr. John Roland Westine is board certified in oral maxillofacial surgery and is a licensed dentist. He has studied the use of electrical energy in destroying tissue and has used electro-surgical equipment for thirty years. Dr. Westine is familiar with radiofrequency thermoneurolysis. Prior to the final hearing, he had reviewed the records of forty patients who had been treated with radiofrequency thermoneurolysis. It was his opinion that the proposed procedure was not safe and could cause the following problems: irreparable damage to vision, stroke, motor deficiencies, damage to facial nerves, nerve deficits, sensory deficits, abscess formations and parotid fistulas. Based on the preponderance of the evidence, Dr. Phillips has not demonstrated that the fluoroscopic radiofrequency thermoneurolysis is widely accepted by the practicing peer group, that the procedure is based on scientific criteria, or that the procedure is reasonably safe. Radiofrequency thermoneurolysis, including fluoroscopic radiofrequency thermoneurolysis, is an experimental procedure.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered determining that fluoroscopic radiofrequency thermoneurolysis is experimental and denying approval for the procedure. DONE AND ENTERED this 29th day of August, 1995, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 29th day of August, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-762 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1. Petitioner did not designate which portion of his proposed recommended order contained the proposed findings of fact and which portion contained the proposed conclusions of law; thus, I am unable to address the paragraphs which Petitioner may contend are his proposed findings of fact. Respondent's Proposed Findings of Fact. Paragraphs 1-5: Accepted in substance. Paragraphs 6-7: Accepted that that is what the statutes and rule say. Paragraph 8: The first sentence is accepted in substance. The second sentence is accepted to the extent that the Division does submit the documentation to consultants. The evidence established that the proposed treatment is not for use in the aid or confirmation of a diagnosis; therefore, the Division would not be required to submit the documentation to four consultants based on Rule 38F-7.0201, F.A.C. Paragraph 9: Accepted in substance. Paragraph 10: Accepted. Paragraph 11: Rejected as unnecessary. Paragraphs 12-15: Accepted in substance. Paragraph 16: Rejected as constituting argument. Intervenors Proposed Findings of Fact. Paragraphs 1-2: Accepted in substance. Paragraph 3: Rejected as unnecessary detail. Paragraphs 4: Accepted. Paragraph 5: The last sentence is rejected as unnecessary. The remainder is accepted in substance. Paragraph 6: Accepted in substance. Paragraph 7: Rejected as unnecessary detail. Paragraphs 8-9: Accepted to the extent that Dr. Phillips desires to use the proposed treatment. The remainder is rejected as unnecessary. Paragraph 10: Rejected as not supported by the greater weight of the evidence. Paragraph 11: Rejected as unnecessary. Paragraphs 12-15: Accepted in substance. Paragraph 16: Rejected as unnecessary. Paragraph 17: The first sentence is rejected as unnecessary. The second sentence is accepted in substance. Paragraph 18: Accepted in substance. Paragraph 19: The first four sentences are accepted in substance. The remaining is rejected as unnecessary. Paragraphs 20-21: Accepted in substance. Paragraphs 22-31: Rejected as unnecessary. Paragraphs 32-35: Accepted in substance. Paragraph 36: Rejected as unnecessary. Paragraphs 37-39: Accepted in substance. Paragraphs 40-41: Rejected as unnecessary. COPIES FURNISHED: Robert R. Johnson, Esquire Post Office Box 3466 West Palm Beach, Florida 33402 Michael Moore, Esquire Office of the General Counsel Department of Labor & Employment Security 2012 Capitol Circle Southeast, Suite S-307 Tallahassee, Florida 32399-2189 Nancy Lehman, Esquire Neil J. Hayes, P.A. 224 Datura Street, Suite 601 West Palm Beach, Florida 33401 Douglas L. Jamerson, Secretary Department of Labor and Employment Security 303 Hartman Building 2012 Capital Circle Southeast Tallahassee, Florida 32399-2152 Edward A. Dion Department of Labor and Employment Security General Counsel Department of Labor and Employment Security 303 Hartman Building 2012 Capital Circle Southeast Tallahassee, Florida 32399-2152
