Findings Of Fact The Petitioner is the state agency charged by statute with regulating the practice of medicine in Florida. At all times material to this case, John Isaac Delgado (Respondent) has been a physician in the state, holding Florida license number ME 0054871. The Respondent's last address of record is 7820 North Armenia Avenue, Tampa, Florida, 33629. The Respondent has been licensed to practice in Florida since 1989. At about 8:30 p.m. on February 9, 1992, Patient W. S. (Patient) presented to the Emergency Room at St. Joseph's Hospital, Tampa, apparently complaining of right lower quadrant pain. Immediately prior to being seen at the emergency room, the Patient had been playing cards with friends and had apparently fainted. The Patient, a 74 year old obese white male, had a history of diabetes, coronary artery disease and had a previous myocardial infarction. At the emergency room, the Patient was initially examined by John C. Siano, M.D. Dr. Siano ordered chest and abdominal x-rays. The Respondent was the internist on call at the time the Patient was examined in the emergency room. Dr. Siano contacted the Respondent and notified him of the situation. The Respondent examined the Patient at about 10 p.m. The examination was extensively documented. At the time the Respondent initially examined the Patient, the Patient provided an incomplete summary of his symptoms. The Patient had apparently informed emergency room personnel of severe pain; however, this information was not provided to the Respondent. The Respondent was aware only of intermittent abdominal pain. The Patient's emergency room records were missing at the time of the Respondent's examination. The Respondent unsuccessfully attempted to locate the Patient's records during his examination of the patient. Upon examination, the Respondent determined that the Patient's blood pressure was within normal range and was stable. The Patient was alert and oriented. Vital signs were normal. The patient appeared to be in stable condition. While in the emergency room, the Patient had a bowel movement which tested positive for the presence of blood. A nasogastric tube exiting from the Patient indicated "coffee grounds" material. These factors are indicative of a gastrointestinal problem. The presence of blood in the intestinal tract and abdominal pain is indicative of a gastrointestinal disorder. The evidence fails to establish that the patient presented an emergency condition at the time of the Respondent's examination. Back pain is a symptom of an expanding abdominal aortic aneurysm. An expanding aneurysm presses against nerves and muscle in the back and sides of a patient. In this case, the aneurysm was of considerable size; nonetheless, the evidence fails to establish that the Patient informed the Respondent of severe back pain. Severe continuing abdominal pain may be a symptom of a ruptured abdominal aortic aneurysm. The evidence fails to establish that the Patient informed the Respondent of severe continuing abdominal pain. There was no palpable pulsatile mass in the Patient's abdomen which would have been indicative of an aneurysm. There was no "bruit" sound emanating from the patient's abdomen. Such sounds are indicative of an aneurysm. There was no asymmetry of pulses in the Patient's legs which would have been indicative of the aneurysm. Hypotension, such as may result in fainting, can be indicative of an aneurysm. The patient was hypotensive when he arrived at the emergency room; however, treatment with intravenous fluids brought the Patient's pressure back to a normal range within a few minutes, indicating that internal bleeding was not significant. Based on the symptoms described by the patient and on review of the patient's condition, the Respondent's tentative diagnosis was upper gastrointestinal bleeding, likely peptic ulcer disease with bleeding secondary to chronic aspirin usage and colonic polyps. There was also a suggestion of acute diverticulitis with associated bleeding. The Respondent ordered a series of abdominal x-rays be taken. The Respondent ordered appropriate diagnostic studies based on his tentative diagnosis. The tests were scheduled for the morning. The Respondent also requested a surgical consultation, which was also scheduled for the morning. Based on the examination and discussion with Dr. Siano, the Respondent admitted the Patient to a regular floor for further observation. At the time the Patient was admitted, the Respondent had not reviewed the results of the abdominal x-rays. The Respondent did not review the x-rays prior to leaving the hospital that night. The evidence is insufficient to establish that the Respondent's failure to review the x-rays prior to admission or prior to leaving the hospital for the night violated the acceptable standard of care. Based on the patient's condition as expressed to the Respondent and on the results of the examination, the evidence fails to establish that the Respondent should have diagnosed the situation as an aneurysm. The mere existence of an aneurysm is not a surgical emergency. Whether to surgically treat an aneurysm depends on a number of other factors. A ruptured aneurysm is an emergency life threatening condition. Time is critical when responding to a ruptured aneurysm. The evidence is insufficient to establish that the Respondent knew or should have known that the Patient was suffering from a ruptured aneurysm. In the morning of February 10, 1992, a general surgical consultation was done by Frederick Reddy, M.D. Dr. Reddy examined the patient and reviewed the abdominal x-rays which had been taken on the Respondent's orders. According to Dr. Reddy, at the time of his exam the patient complained of intermittent abdominal pain, and said that he had a history of back pain, but did not complain of back pain at that time. Dr. Reddy's review of the x-rays indicated the presence of calcification. While calcification is indicative of an possible aneurysm, the evidence fails to establish that the Patient's aneurysm is clearly indicated by the x-rays. Dr. Reddy saw no indication of rupture, but referred the case to a radiologist and ordered a CT scan on the radiologist's recommendation. The CT scan indicated that an aneurysm had ruptured. The Patient was taken to surgery where G. K. James, M.D. repaired the ruptured aneurysm and performed an aortobifemoral bypass graft. The Patient's condition deteriorated and he expired on February 10, 1992. The evidence fails to establish that the outcome of the case would have been different had the Respondent diagnosed the problem as a ruptured abdominal aortic aneurysm or had the surgical procedure been performed at an earlier time after the Patient's arrival at the hospital emergency room.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order dismissing the Administrative Complaint filed in this case. DONE and ENTERED this 27th day of February, 1996, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM, Hearing Officer Division of Administrative Hearing The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of February, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1981 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. The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1. Rejected, not supported by cited evidence. Petitioner's exhibit Number 1 identifies the Respondent's address as set forth herein. Rejected. The greater weight of evidence fails to establish that the x-rays revealed the presence of a ruptured aneurysm. The ruptured aneurysm was diagnosed after a CT scan and review by a radiologist. Rejected, subordinate. While the statement that the cited physician always reads his ordered x-rays is correct, the evidence fails to establish that failure to do so is a violation of the acceptable standard of care. Rejected. The cited evidence does not establish that the x-ray "very clearly" suggests the aneurysm. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. No evidence that the Respondent was aware of the statement made by the Patient. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent required an immediate consultation. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent indicated a course of treatment other than as set by the Respondent. Rejected, subordinate. Rejected. Not supported by the greater weight of credible and persuasive evidence. Respondent's Proposed Findings of Fact. The Respondent's proposed findings of fact are set forth in unnumbered paragraphs, many of which fail to contain citation to the record as required by Rule 60Q-2.031(3), Florida Administrative Code. Proposed findings which cite to the record are accepted as modified and incorporated in the Recommended Order, or are otherwise rejected as subordinate or as recitation of testimony. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Steve Rothenburg Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Clifford L. Somers, Esquire 3242 Henderson Boulevard, Suite 301 Tampa, Florida 33609
The Issue Was Petitioner properly graded and given appropriate credit for his answers on the July, 1990 Florida Podiatric Medicine Licensure Examination (Florida Podiatry Examination).
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all times pertinent to the issues herein, Petitioner, Paul L. Sheehy, Jr., candidate No. 20017, was a candidate for licensure by examination as a Podiatrist, and the Board of Podiatry, (Board), was and is the state agency in Florida responsible for the licensing of Podiatrists and the regulation of the Practice of podiatric medicine in this state. Petitioner sat for the July, 1990 Florida Podiatry Examination on July 27, 1991. Petitioner obtained a score of 70.0 percent, representing 210 correct answers. A passing grade requires a score of 72 percent, representing 216 correct answers. Shortly before the beginning of the hearing, Respondent agreed to give Petitioner credit for questions 16 and 180 of Clinical I of the examination thereby raising his total score to 70.666 percent. At the beginning of the hearing, Petitioner withdrew his challenge to questions 22, 37, 87, 89, 104, 149, 176 and 178 of Clinical I of the examination and questions 3, 16, 22, 50, 67 and 53 of Clinical II of the examination. During the hearing Petitioner withdrew his challenge to question 27 of Clinical I and question 12 of Clinical II of the examination, leaving only his challenge to questions 103, 114, 138, 144 of Clinical I of the examination. The parties stipulated that the Petitioner was qualified and met all the requirements to sit for the July, 1990 Florida Podiatry Examination, and that Petitioner timely received a copy of the July 1990, Podiatric Medicine Licensure Examination Candidate Information Booklet (booklet). There is a lack of competent substantial evidence in the record to establish that the Florida Podiatry Examination given on July 27, 1990 was misleading in that it tested subjects or disciplines not covered or contained in the booklet, or that it was prejudicial as applied to Petitioner. The first question at issue is question 103 of Clinical I which stated: CASE HISTORY 44 In the exhibit book are photographs for this examination. Identify the photograph in the respective exhibit. 103. Which of the following answer choices is the best description of exhibit #11? Ganglion Cyst Verruca Melanoma Kaposi's Sarcoma Petitioner answered, C, Melanoma and the Respondent's answer was, B, Verruca. Petitioner admitted that his answer was incorrect. However, Petitioner contends that the question comes within the area of histology, an area not specifically mentioned in the booklet to be covered by the examination. Therefore, he was mislead by the booklet into not studying the area of histology. While the booklet does not specifically mention histology as an area of study to be covered in the examination, there were several other areas of study listed in the booklet which conceivably would have covered this question. Therefore, there has been no showing that the Respondent's failure to specifically list histology as an area of study mislead or prejudiced the Petitioner. The second question at issue is question 114 which stated: CASE HISTORY 45 An elderly obese male presents with an acutely inflamed first metatarsophalangeal joint. The pain began late last night and he awoke in severe pain. His past medical history reveals two previous such occurrences which resolved and went un- treated. He reports a history of chronic renal disease and mild hypertension. He presently takes no medication and has no known allergies. He denies use of alcohol and tobacco. Physical exam reveals an acutely inflamed, edematous 1st MPJ. A 3mm ulceration is present dorsally with white, chalky material exiting the wound. Laboratory studies reveal a CBC within normal limits and an elevated uric acid of 9.0mg/100ml. 114. Which of the following would you expect to find on microscopy of the synovial fluid? trapezoidal-shaped violet crystals absence of leukocytes needle-like birefringent crystals reflective hexagonal crystals and many leukocytes Petitioner answered D, reflective hexagonal crystals and many leukocytes. The Respondent's answer was C, needle-like birefringent crystals. Petitioner contends that none of the answers offered were entirely correct but that answer D was the most correct, while answer C was incorrect. Case History 45 would describe gout and pseudogout, but the key is the description of the fluid removed from the joint which is a white, chalky material found only with gout. Additionally, gout produces needle-like crystals (urate) that are negatively birefringent when view under crossed polarizing filters attached to a microscope. Leukocytes would be present in this case history but it would not produce reflective hexagonal crystals or trapezoidal-shaped violet crystals. Answers A and B are entirely incorrect, and although the presence of leukocytes is correct, it is not relevant because leukocytes are a normally found in any infection. Therefore, answer C is the correct answer, notwithstanding the absence of the word negative proceeding the word birefringent. The third question at issue is question 138 which stated: CASE HISTORY 49 A 27 year old athletic individual presents with a severely painful and swollen right ankle following a basketball injury the day before. There is severe ecchymosis and blister formation about the ankle. X-rays reveal (1) a displaced oblique spiral fracture of the lateral malleolus which runs anterior-inferior to posterior-superior at the level of the syndesmosis (2) transverse fracture of medical malleolus. There is gross dislocation and mal position of the talus. 138. If the initial treatment above were to fail, then treatment should consist of: immediate open reduction. wait 4-6 days, then perform open reduction and internal fixation. open reduction contraindicated at any time with this type of fracture. fusion of ankle joint. Petitioner answered A, immediate open reduction and the Respondent's answer was B, wait 4-6 days, then perform open reduction and internal fixation. The correct initial treatment for the patient would have been attempted close reduction as indicated by the correct answer to question 137 which Petitioner answered correctly. An attempted close reduction is an attempt to correctly align the fractured bone by manipulation as opposed to surgically opening the area and aligning the bone visually by touch which is the open reduction and internal fixation procedure. After an attempted alignment of the bone, an x-ray will determine if there is proper alignment. If there is proper alignment, then the area is immobilized with a cast or some other device until the fracture heals. If the x-ray shows that proper alignment of the bone has not been obtained (the initial treatment has failed) then open reduction and internal fixation would be proper provided the swelling, ecchymosis and blistering are not present. Otherwise, as in this case, the proper method would be to wait a period of time, 4-6 days, for the swelling, ecchymosis and blistering to go away. Petitioner's contention that the swelling had gone down since there had been immobilization of the area with a cast, posterior splint or unna boot and a waiting period is without merit since those devices would not have been used before determining by x-rays that the initial treatment (closed reduction) had failed. The fourth and last question at issue in question 144 which stated: CASE HISTORY 50 A patient presents with a painful left ankle. The pain occurs following ambulation and is relieved by rest. There is minimal periartic- ular atrophy and the joint is slightly warm. X-rays reveal non-uniform joint narrowing, subchondral sclerosis and marginal osteophytes. 144. It can be expected that the patient will favorably respond to treatment but may experience flareups. significant cartilage damage will occur. total joint replacement will be required. total remission can be expected following treatment. Petitioner answered B, significant cartilage damage will occur and Respondent's answer was A, that the patient will favorably respond to treatment but may experience flareups. There were a series of questions preceding this question concerning the patient in Case History 50. The first question asked for a diagnosis which the Petitioner correctly answered as osteoarthritis. The second question concerned advising the patient on treatment which the Petitioner answered correctly by giving instructions on protecting the joint and taking simple analgesics. The third question concerned activity levels such as jogging and climbing steps which Petitioner answered correctly by advising to avoid squatting. However, in selecting B as the answer to question 144 the Petitioner did not consider the suggested treatment and advise given in the previous answers. His reasoning was that he could not assume that the patient would follow his suggested treatment or advise on prevention and activity. Additionally, the Petitioner felt that other factors such as the patient's age, weight, general health, level of activity and occupation that were missing from the case history were necessary to make a proper evaluation of whether the patient would respond favorably to treatment. Respondent admitted that either answer A or B would be correct but he picked B because he knew the disease was progressive and in time would get worse causing significant cartilage damage. Osteoarthritis is a degenerative joint disease that is not uniformly progressive that responds to treatment but cannot be cured. There will be recurring episodes of pain (flareups) triggered by factors such as the weather or a person's activity. Based on the factors in the above case history, there is sufficient evidence to show that the patient will favorably respond to treatment but may experience flareups. It was reasonable and logical for the Respondent to assume that the Petitioner in answering question 14 would consider his preceding answers and assume that the patient would follow the suggested treatment and advice. There is a lack of competent substantial evidence in the record to establish that significant cartilage damage would occur based on the facts given in Case History 50. There is a lack of competent substantial evidence in the record to establish that the grades which the Petitioner received on the July, 1990 Florida Podiatry Examination were incorrect, unfair, or invalid, or that the examination, and subsequent review session, were administered in an arbitrary or capricious manner.
Recommendation Based upon the foregoing, it is recommended that Respondent enter a Final Order dismissing the Petitioner's challenge to the grade he received on the July 1990, Florida Podiatry Examination. RECOMMENDED this 18th day of September, 1991, in Tallahassee, Florida. WILLIAM R. CAVE 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 18th day of September, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-2118 The following contributes my specific rulings pursuant to Section 120- 59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties in the case. Rulings on Proposed Finding of Fact Submitted by the Petitioner Adopted in substance in Findings of Fact 1 and 4. Adopted in substance in Finding of Fact 4. Rejected as not supported by competent substantial evidence in the record. Rulings on Proposed Findings of Fact Submitted by the Respondent Adopted in substance in Findings of Fact 1 and 2. Adopted in substance in Finding of Fact 2. Adopted in substance in Finding of Fact 3. 4.-6. Adopted in substance in Findings of Fact 6, 7, and 8, respectively. 7. Adopted in substance in Findings of Fact 9 and 10. COPIES FURNISHED: Hewitt E. Smith, Esquire P.O. Box 76081 Tampa, FL 33675 Vytas J. Urba, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Patricia Guilford, Executive Director Board of Podiatry 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issues for determination in this Hearing are whether the Respondent has violated the provisions of Chapter 461, Florida Statutes, as alleged in the Amended Administrative Complaint and, if so, what discipline, if any, is appropriate. FINDINGS OF FACT 1/ The Board of Podiatric Medicine is the State agency governing the practice of podiatry in the State of Florida. Respondent, Dode A. Hoskins, D.P.M., is and has been at all times material to the allegations in the Amended Administrative Complaint, a licensed physician in the state of Florida, having been issued license number PO-0001072. PATIENT SCHELLENBERG - DPR CASE NO. 0080076 On or about July 22, 1986, Respondent treated a patient, J. Schellenberg, for an ingrown toenail on the right foot. Respondent billed for the following services: Consultation; X-rays, right foot, three views; X-rays, left foot, three views; Three preoperative vascular flow studies; Excision of nail and matrix lateral aspect; Excision of nail and matrix medical aspect; Injection of peripheral nerve; and Sterile surgical tray. The following services were not necessary nor indicated in regard to this patient's condition; The X-rays of the left foot; The preoperative vascular flow studies. Respondent has exercised influence on the patient Schellenberg in such a manner as to exploit the patient for financial gain of the Respondent. By performing services on the patient Schellenberg which were not necessary nor indicated, Respondent failed to practice podiatric medicine at a level of care, skill and treatment which is recognized by a reasonably prudent podiatrist as being acceptable under similar conditions and circumstances. The records kept by the Respondent fail to justify the preoperative vascular flow studies on the patient Schellenberg and fail to adequately justify the X-rays on the left foot. /2 PATIENT SANDERS - DPR CASE NO. 0085886 On or about, February 20, 1987, the Respondent performed surgery on the patient, Lois Sanders. The Respondent performed the following surgical procedures on patient Sanders: Arthroplasty on fifth toes, left and right feet; Tenotomy and capsolotomy on toes 2 through 5, left and right feet. The Respondent's medical records and x-rays fail to justify the course of treatment on any of toes 2, 3, and 4 of either of Sanders' feet. Although the patient was requested to sign numerous consent forms prior to surgery, the extent and the necessity for surgery on toes 2, 3, and 4 on both feet and the acceptable alternatives and substantial risks and hazards inherent in the procedures were not explained to the patient. Respondent has performed professional services which have not been duly authorized by the patient or her legal representative. The surgery to toes 2, 3, and 4 on both feet was not justified by the patient's condition. By performing surgeries which were unnecessary, the Respondent exercised influence on the patient in such a manner as to exploit the patient for financial gain of the Respondent. In his treatment of Sanders, Respondent failed to practice podiatric medicine at a level of care, skill, and treatment which is recognized by a reasonably prudent podiatrist as being acceptable under similar conditions and circumstances. On or about February 4, 1987, the Respondent had performed on patient Sanders a vascular flow examination. Respondent's medical records do not substantiate the necessity for performing a vascular flow examination on Sanders. By performing a vascular flow study on Sanders, the Respondent has exercised influence on the patient Sanders for financial gain of the Respondent. PATIENT KOSHAR - DPR CASE NO. 0087508 During August of 1986, the patient, Sue Koshar, presented at the offices of the Respondent with a complaint of planters wart on the left foot and ingrown nail on the left foot. Between August 29, 1986, and December 6, 1986, the Respondent performed laser surgery for the treatment of the planters wart on the patient Koshar on four occasions. The Respondent failed to anesthetize the area before performing laser surgery on the first three occasions. The patient's complaints concerning a burning sensation caused the Respondent to stop the surgery on the first three occasions before it was completed. Respondent's medical records: do not reflect the patient's complaints of a burning sensation; do not reflect that the surgery was not completed after the first two visits or that surgery was not completed on the first three visits due to the patient's complaints of a burning sensation; indicate that laser was utilized on two occasions when it was actually utilized on four occasions; indicate that local anesthesia was utilized at the time of the first use of the laser, when in fact local anesthesia was only used at the time of the last laser surgery; and fail to reflect that adequate postoperative care was given to the patient Sue Koshar. Respondent has failed to keep written records justifying the course of treatment of the patient Koshar. The records do not explain why surgery was redone on three occasions, do not explain why no anesthesia was administered on three of the surgeries and do not identify the kind of anesthesia administered on the last surgery or explain why it was used. Respondent has, in regard to patient Koshar, failed to practice Podiatric Medicine at a level of care, skill, and treatment which is recognized by a reasonably prudent podiatrist as being acceptable under similar conditions and circumstances, for the following reasons: Respondent failed to properly anesthetize the patient Koshar at the time of the first three laser surgeries, resulting in multiple painful and unsuccessful procedures; Respondent failed to adequately provide postoperative care to patient Koshar following her surgeries; and Respondent failed to keep medical records necessary to adequately treat the patient's conditions. On or about August 29, 1986, the Respondent performed vascular flow studies on patient Koshar. Respondent's records do not substantiate the necessity for performing vascular flow studies on patient Koshar. Vascular flow studies were not indicated in the diagnosis or treatment of patient Koshar's complaints. Respondent has exercised influence on the patient or client in such a manner as to exploit the patient or client for financial gain of the Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: that the licensure of the Respondent be suspended for one year and until such time as Respondent has completed 50 hours of continuing podiatric medical education as designated by the Board (in addition to those hours required for license renewal) and pays a fine in the amount of $10,000.00, and that, upon reinstatement, the license of Respondent be placed in a probationary status for a period of two years under conditions imposed by the Board but including requirements that the Respondent: work only under indirect supervision of another podiatric physician who shall review Respondent's records on a monthly basis; submit quarterly reports to the Board; make annual appearances before the Board; and only perform vascular testing on those patients whose history or physical findings show possible impaired circulation. In addition, Respondent shall only perform vascular testing on those patients whose history or physical findings show possible impaired circulation. DONE AND ENTERED this 28th day of September, 1989, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 28th day of September, 1989.
Findings Of Fact John D. Elder is a site worker at Port St. Lucie High School, having first been employed by the St. Lucie County School Board as a temporary employee in the summer of 1993. When first employed, Mr. Elder rejected the option to enroll in the employer's insurance plan. In September 1993, Mr. Elder was given an employer's insurance form allowing ninety days for enrollment. On November 12, 1993, he completed the form and became eligible for certain benefits on January 1, 1994. The St. Lucie County School Board Medical Benefit Plans, in which Mr. Elder enrolled, excludes coverge for pre-existing conditions until the end of 12 months of continuous coverage. The plans include the following definitions: A pre-existing condition is an injury, sickness or pregnancy or any condition related to that injury, sickness or pregnancy, where a diagnosis, treatment, medical advice or expense was incurred within twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include any injury, sickness or pregnancy or related condition that manifested itself twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include the existence of symptoms which would cause an ordinarily prudent person to seek diagnosis, care or treatment within twelve (12) months prior to the effective date of this coverage. (Emphasis Added.) From 1985 to 1988, Mr. Elder was treated by Dr. Urban who, on March 24, 1988, performed an electrocardiogram ("EKG"), which was normal. Dr. Urban treated Mr. Elder for respiratory illnesses, such as bronchitis and pleurisy, for back and shoulder muscle spasms, bursitis/tendonitis, and for high blood pressure. On September 21, 1988, Mr. Elder first saw Dr. Richard Dube. On that day, his heart rate was 62, as compared to the normal range of 60 to 100. In October 1988, Dr. Dube treated Mr. Elder for an inflammation of the muscle behind his shoulder. In December 1988 and January 1989, he treated Mr. Elder for high blood pressure and headaches. In July 1991, Mr. Elder called an ambulance and was taken to the hospital complaining of pain in his neck, across his shoulders, and down his arms. Among other tests, an EKG was performed. The diagnosis was tendonitis in his right shoulder. Later that same year, Mr. Elder complained of heart burn. Dr. Dube treated him for epigastric distress and high blood pressure. Blood test analyses of his cholesterol and high, low and very low density lipid levels indicated a cardiac risk factor of 10.3 for Mr. Elder, which is more than twice the standard male risk factor of 5.0. Dr. Dube ordered blood tests again in January 1993, at which time Mr. Elder's cholesterol and high density lipid levels were still high, but had decreased, reducing the cardiac risk factor to 8.0. Dr. Dube also referred Mr. Elder for an ultrasound of the gallbladder, which was diagnosed on January 29, 1993, as having calcification, which could represent a gallstone, and probably having a small polyp. At the same time he treated Mr. Elder for carpal tunnel syndrome and temporomandibular joint syndrome ("TMJ"). Most recently, on July 27, 1993, the same tests were repeated. With cholesterol in the normal range, the cardiac risk factor was decreased to 6.5. In the fall of 1993, Mr. Elder's complaints were diagnosed as episgastric reflux. To reassure Mr. Elder, Dr. Dube ordered another EKG, which was performed on November 23, 1993, and was normal. On January 3, 1994, Mr. Elder's complaints of ongoing pain caused Dr. Dube, who suspected he had a hiatal hernia, to refer him to Dr. Dan G. Jacobson for an upper endoscopy. Dr. Jacobson recorded a history of episgastric/chest pain, hypertension, ulcers and arthritis. Dr. Jacobson also noted a family history described as "remarkable for heart problems, heart attack." The admitting diagnosis was "history of episgastric pain refractory to medical therapy." Dr. Jacobson performed the endoscopy and diagnosed mild stomach gastritis. Based on a two week history of epigastric and chest pain, and his conclusion that the pain was too severe to result from the endoscopy findings, Dr. Jacobson consulted a cardiologist. Dr. Robert N. Blews, a cardiologist, saw Mr. Elder in the hospital. The history taken by Dr. Blews noted (1) that Mr. Elder's father died of a heart attack at age 68, and that his mother had coronary bypass surgery at age 48 and died at age 59, (2) that the onset of "chest tightness" was approximately one year prior, and (3) that he has a history of cervical spine disease. Dr. Blews' notes also reflected a change in the pattern of the chest pains in the last one to two months, and additional changes in the last two weeks. The longest episodes of pain were lasting from 20 to 30 minutes, with associated sweating and shortness of breath. Mr. Elder also told Dr. Blews that the pain could be with exercise, at rest, could awaken him, and occurred while he was just walking to his car. The report describes Mr. Elder as having a history of smoking. The EKG which Dr. Blews ordered on January 8, 1994 showed a major blockage on the left side of the heart, and is significantly different from all of the prior EKGs, including that taken on November 23, 1993. Dr. Blews concluded that Mr. Elder was having angina, or a decrease in the blood supply to his heart two weeks, two months, and a year before January 1994. Mr. Elder's wife, Florinda Elder, has been aware of his complaints of stomach problems for 10 years, but had no knowledge of his heart problems until January 1994. She was not aware of his having ever smoked or complained of shortness of breath. Although she was at the hospital, Mrs. Elder was not in the room when Dr. Blews took her husband's medical history. Mr. Elder's shoulder and muscle aches, and cervical spine pain are the result of a serious car accident in 1969. The pains are aggravated by cold weather. Mr. Elder claims to have been under the effects of anesthesia at the time Dr. Blews took his medical history, and denies having had a year of chest tightness, shortness of breath, or difficulty walking to his car. He has not smoked for 20-25 years, which is not inconsistent with Dr. Blews' report of a "history of smoking." Mr. Elder's attempt to undermine Dr. Blews history is specifically rejected. The McCreary Corporation is the administrator of the St. Lucie County School Board's self-insurance plan, which contracts with a consultant, Independent Health Watch. Kay Trentor, R.N., reviewed the claims submitted by Mr. Elder, and concluded that his coronary artery disease was a pre-existing condition. In part, Ms. Trentor was relying on Dr. Blews history of a year of "chest tightness." Mr. Elder's records were also sent for peer review, to two other consultant organizations, Professional Peer Review, Inc. and Medical Review Institute of America, Inc. They, in turn, sent the records to Board certified cardiologists, with cardiovascular disease subspecialties. The first report concludes that Mr. Elder "should have known that he had coronary disease because he had multiple risk factors for heart disease," and that "if he was reasonably prudent he would have had this taken care of during the time he was having chest pain walking to the car." The second peer review report also notes a year of chest tightness, with symptoms worsened "over the two months preceding the admission, but . . . not recognized as cardiac until the hospitalization on January 7, 1994." The report concludes that coronary artery disease was not diagnosed until after the effective date. The second report was prepared by Ronald Jenkins, M.D., who believes that Drs. Dube and Jacobson, "seemed to be focusing on gastrointestinal diagnoses . . . and had kind of missed the boat, so to speak . . .," but that "an ordinarily prudent person with John Elder's symptoms which he reported prior to January 1, 1994, [would] have sought medical treatment for those symptoms." Coronary artery disease takes years to develop, but is erratic in manifesting itself, with some people having no symptoms to severe symptoms over a matter of hours. Dr. Dube described it as "silent" coronary disease. Dr. Blews estimates that a heart attack is the first symptom in 40 percent of patients. There is no dispute that Mr. Elder has had other medical conditions, including TMJ, arthritis, and gastroenterological problems. Dr. Jenkins believes the most important manifestation of coronary artery disease was upper precordial chest tightness going to the left upper extremity as well as to the throat. When the history indicates that the tightness occurs with exercise, according to Dr. Jenkins that gives 90 percent confidence that it is anginal chest pain. That confidence level increases to 95 percent when he notes that Mr. Elder told Dr. Blews that chest discomfort occurs when he walks to his car. Without that history, however, Dr. Jenkins would not be able to conclude that the chest discomfort is due to heart disease or that the cardiac condition manifested itself prior to January 1, 1994. Dr. Jenkins described chest heaviness, aggravated by being in cold weather, as a symptom of coronary disease. The same pain without multiple risk factors, occuring irregularly, is a reason for "looking into other alternative diagnoses." Dr. Jenkins also acknowledges that episgastric reflux can cause chest discomfort and throat pain, and that cervical spine degenerative disc disease can cause a radiation of symptoms into the upper extremities, as it did when Mr. Elder called an ambulance in 1991. Dr. Blews did not have trouble getting a complete, detailed history from Mr. Elder. He typically has to elicit a more specific description from patients complaining of chest discomfort. He gives choices such as pain, burn, stab, jab, tight, squeeze or pressure, from which Mr. Elder chose "tight." Dr. Blews also found that Mr. Elder had chest wall pain in several spots or fibrosistitis, which is not a symptom of heart disease. Chest tightness could also be attributable to asthma, according to Dr. Blews, but with radiating pain into the left arm, jaw, and throat, shortness of breath, and sweating, he was certain Mr. Elder had heart disease. All of the doctors agree that Mr. Elder's heart disease existed before January 1, 1994, and that he had no diagnosis, treatment, medical advise or expense related to heart disease in the 12 months prior to January 7, 1994. There is no evidence that he was ever evasive or uncooperative with doctors. On the contrary, Mr. Elder was consistently described in doctor's notes and hospital records as anxious or concerned about his health. Coronary artery disease had not manifested itself to Mr. Elder or his doctors prior to Dr. Jacobson's decision to consult with Dr. Blews. "Manifest" is defined in Respondent's exhibit 9, a page from the International Classification of Diseases, 9th Revision, 1995, or ICD-9, as "characteristic signs or symptoms of an illness." The doctors who testified, in person or by deposition, described every sign or symptom experienced prior to Dr. Blews' consultation, as also being a sign or symptom of Mr. Elder's other medical conditions. Mr. Elder's symptoms might have been diagnosed as also indicating that he had heart disease, if he had been referred to a cardiologist sooner. There is no factual basis to conclude that Mr. Elder, or any ordinarily prudent person, should have sought diagnosis, care, or treatment for heart disease when, in fact, his doctor reassured him that his EKG was normal.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Respondent enter a Final Order approving Petitioner's claim for payment of medical expenses in the amount stipulated by the parties. DONE AND ENTERED this 12th day of July, 1995, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER 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 12th day of July, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-0373 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. Accepted in preliminary statement and Findings of Fact 2. Accepted in Findings of Fact 3. Subordinate to Findings of Fact 3. Accepted in Findings of Fact 22. Accepted in Findings of Fact 5-8. Accepted in Findings of Fact 5-8 and 12. Accepted in Findings of Fact 7 and 10. Accepted in Conclusions of Law. Accepted in or subordinate to Findings of Fact 6. Respondent's Proposed Findings of Fact. 1. Accepted in Findings of Fact 1 and 2. 2-3. Accepted in Findings of Fact 2. 4-5. Accepted in Findings of Fact 3. Accepted as corrected in Findings of Fact 23. Accepted in Findings of Fact 9. Accepted in Findings of Fact 8 and 9. 9-12. Accepted in or subordinate to Findings of Fact 9. 13-15. Accepted in Findings of Fact 20. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 20. Accepted in or subordinate to Findings of Fact 15-23. Accepted in preliminary statement and Findings of Fact 13. Accepted in or subordinate to Findings of Fact 14-16. Accepted in Findings of Fact 14 and 15. Accepted in Findings of Fact 16. Accepted in Findings of Fact 8. Accepted in Findings of Fact 9 and 20. Accepted in Findings of Fact 23. Accepted in Findings of Fact 17. Accepted in Findings of Fact 23. Accepted, but Dr. Dube's testimony was found credible and corroborated by his notes. COPIES FURNISHED: John T. Kennedy, Esquire The Injury Law Offices of John T. Kennedy 309 East Osceola Street Suite 306 Stuart, Florida 34994 C. Deborah Bain, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Lane, P.A. 1645 Palm Beach Lakes Boulevard Suite 700 Post Office Box 2508 West Palm Beach, Florida 33401 Frank T. Brogan Commissioner of Education The Capitol Tallahassee, Florida 32399-0400 Dr. David Mosme, Superintendent St. Lucie County School Board 2909 Delaware Avenue Ft. Pierce, Florida 34947-7299
The Issue The issues in this case are whether Respondent violated section 458.331(1)(t), Florida Statutes (2008),1/ and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. Dr. Puig was at all times material to the allegations in the Administrative Complaint a licensed physician in the State of Florida, having been issued license No. 82847. Dr. Puig holds a certificate from the American Board of Anesthesiology. In the early morning of January 2, 2009, T.M. presented to the Central Florida Surgery Center in Lakeland, Florida, for outpatient surgery to be performed by Shreekant Tripathi, M.D. The specific procedures to be performed were bilateral lower eyelid blepharoplasty, mini-face lift, and suspension of the mid-face area with the Endotine Midface implant device. She was accompanied by her husband, R.R. T.M. has been licensed as a physician in Florida for 28 years and has worked as the head of the Tampa General Hospital Adult Emergency Department and as that hospital's chief of staff. T.M. has a prior history of a deep vein thrombosis (DVT), which was treated medically. She experienced a DVT in her leg sitting in an airplane for an extended period of time while traveling from Florida to the Midwest. DVT is a medical condition that occurs when a thrombus (blood clot) forms in one of the large veins, leading to either partial or complete blockage of the vein. After completing the financial paperwork and other forms at the front desk of Central Florida Surgery Center, T.M. was taken to the pre-operative holding area at approximately 7:00 a.m. Once in the pre-operative holding area, the nurse went over the contents of T.M.'s procedures and reviewed T.M.'s medical history and medications taken. The nurse administered medications other than sedation and took T.M.'s vital signs, including her blood pressure. In order to take T.M.'s blood pressure, the nurse in the pre-operative holding area placed a blood pressure cuff on T.M.'s right upper arm. The blood pressure cuff would not have given a reading if it was placed too tightly, and T.M. would have complained of pain. At the time that the blood pressure cuff was placed, T.M. was awake and alert and did not express any discomfort. The nurse was able to get a reading from the blood pressure cuff. While T.M. was in the pre-operative holding area and after the vital signs were taken, T.M.'s temperature was 97.4 degrees. T.M. met with Dr. Tripathi, who went over her surgery with her. Dr. Tripathi marked the areas for her facial cosmetic procedures. Dr. Puig served on the surgical team as anesthesiologist. He conducted a pre-anesthesia evaluation of T.M. Dr. Puig examined T.M. and reviewed the medications that she was taking. He also reviewed T.M.'s medical history, including her history of DVT. As part of his plan for anesthesia, Dr. Puig included the use of sequential compression devices on T.M.'s lower extremities. While in the pre-operative holding area, T.M. was given Versed as a pre-medication for the surgery. T.M. was taken to the operating room, accompanied by Dr. Puig, who remained with T.M. until she was handed to the post-anesthesia care unit (PACU) nurse. T.M. entered the operating room at 8:19 a.m. The blood pressure cuff that was placed by the pre-operative nurse was left in place on the upper right arm. The blood pressure cuff was disconnected from the monitoring device in the pre-operative holding area and accompanied T.M. into the operating room, where it was connected to another monitoring device. After T.M. was taken to the operating room, she moved onto the operating table on her own with some assistance. Monitoring equipment was then connected to T.M. The monitoring equipment included a pulse oximeter on the left hand, sequential compression devices on the lower extremities, and the blood pressure monitoring device. Dr. Puig did not use any device to monitor T.M.'s temperature during the surgery. An IV had been placed in the pre-operative area on T.M.'s left wrist and was running in the operating room. T.M. was positioned flat on her back on the operating table with her shoulders on the operating table using a mattress, a pillow, foam pads, and sheets. On the table, under T.M., was a two-to-three-inch thick mattress. On top of the mattress, under T.M., was a bottom sheet that ran longitudinally the length of the table. On top of the bottom sheet, perpendicular with, or at a 90-degree angle to the table, was a folded sheet from 18-to-30 inches wide. This crossways sheet is called a draw sheet and was under T.M. with the top edge at the armpit and the lower end in line with the waist or buttocks. The draw sheet was pulled up between T.M.'s arm and torso for later tucking. A foam pad, egg-crate device was placed on the right arm between the arm and the table and T.M. The device is not large enough to completely cover the arm. The bottom sheet was tucked around the arm between the egg-crate device and T.M.'s torso. The draw sheet was then tucked around the outside of the arm and under the mattress with a portion left protruding, which could be pulled on later to begin the process of removing the sheets. The purpose of the sheets was to keep T.M.'s arm from falling off the table during surgery. The sheets were supposed to be snug, but not so tight that one could not insert two fingers between the sheets and T.M.'s arm. In addition to the sheets that covered T.M., a Bair Hugger was used. A Bair Hugger is a warming device that uses forced warm air to keep a patient warm during surgery. The blood pressure cuff was under a portion of the egg-crate device, the bottom sheet, the draw sheet, and the Bair Hugger. The top edge of the blood pressure cuff was just under the armpit and the bottom edge was approximately three-to-four inches above the elbow joint. The blood pressure cuff had an inflatable rubber bladder and normally would have an attached inlet tube about six-to-eight inches long that would extend down T.M.'s arm toward her wrist. In order to eliminate sources of infection, a sterile field was created by using sterile towels and sterile drapes. The sterile drape covered T.M. after the other sheets and blankets were in place. The sterile towels were placed around T.M.'s head. At 8:41 a.m., the surgery began. Prior to the commencement of surgery and while in the operating room, Dr. Puig monitored T.M.'s blood pressure using the monitoring device in the operating room and the blood pressure cuff that was placed on T.M.'s right arm. Dr. Puig had blood pressure readings until 8:58 a.m., when Dr. Puig was unable to get blood pressure readings. Dr. Puig asked Dr. Tripathi to step aside and allow him to check the blood pressure cuff. Dr. Puig was on the right side of T.M. and moved to the left side of T.M. He asked the circulating nurse to hold the sterile drape so that he could go under the drape to check the blood pressure cuff. Dr. Puig went under the drape and felt the blood pressure cuff. The blood pressure cuff was deflated. He disconnected the tube from the blood pressure cuff and called for a new blood pressure cuff. He placed the new blood pressure cuff on T.M.'s left arm and connected the new blood pressure cuff to the blood pressure monitoring device. Dr. Puig was able to get accurate blood pressure readings from the new blood pressure cuff and the monitoring device that had been attached to the blood pressure cuff on T.M.'s right arm. Dr. Puig left the deflated blood pressure cuff on T.M.'s right arm during the surgery. After a blood pressure cuff was placed on T.M.'s left arm, Dr. Tripathi continued with the surgery. The surgery ended at 1:48 p.m., at which time the circulating nurse began to remove the sterile drape and sheets from T.M. When the nurse removed the deflated blood pressure cuff on T.M.'s right arm, she noticed that the arm below the blood pressure cuff was mottled, blue, red, dark blue and dark red. There were blisters on T.M.'s right arm where the blood pressure cuff had been. T.M.'s right arm was swollen. The condition of T.M.'s right arm was brought to the attention of Dr. Puig. Dr. Puig examined and evaluated T.M.'s condition. At 2:00 p.m., T.M. was transferred to the PACU. T.M. was alert. Her temperature was 98 degrees. Her husband, R.R., was at bedside when T.M. was taken to PACU and stayed at her bedside until T.M. was discharged. T.M. was experiencing extreme pain in her right arm and felt a tender hard spot on her right bicep. The post- operative nurse noted the condition of T.M's right arm as red and swollen from the biceps to the tips of T.M.'s fingers with blisters on the upper part of the extremity. Dr. Puig noted that T.M. had decreased sensation in her right finger tips and some decrease in motor activity and that T.M's radial and ulnar pulses were intact. He ordered that the right arm be elevated with the use of pillows. At 2:15 p.m., Dr. Puig was at T.M.'s bedside, monitoring T.M.'s condition. Dr. Tripathi was aware of T.M.'s condition and also appeared at her bedside to monitor her condition. Dr. Puig consulted with Dr. Tripathi concerning T.M.'s condition. At 2:30 p.m., T.M. was still being monitored by the PACU nurse. T.M. was moving her arm, fingers, and wrist. At 2:55 p.m., T.M. told the nurse that she was unable to feel her pulse. Two nurses took T.M.'s pulse and verified that T.M. did have a pulse. Dr. Puig and Dr. Tripathi had gone back to the operating room for a procedure on another patient. At 2:55 p.m., a nurse notified Dr. Puig of T.M.'s complaint of feeling no pulse. At 3:08 p.m., T.M. complained of a decrease in sensation from her elbow to her fingers. T.M. suggested to the PACU nurse that measurements should be taken of the circumference of her arms to determine how much swelling had occurred. At 3:10 p.m., the nurse marked the area on the arms to be measured and took measurements of the bicep and forearm in each arm. The right bicep measured 30 centimeters, and the right forearm measured 28 centimeters. The left bicep measured 29 centimeters, and the forearm measured centimeters. T.M. and her husband became concerned about the condition of T.M.'s right arm. The right arm was still elevated by pillows, and T.M. continued to exercise the arm. At 3:14 p.m., T.M. stated that she could feel her right radial pulse. T.M.'s right bicep remained red and swollen. T.M. denied the need for pain medication. At 3:20 p.m., T.M. continued to exercise the right arm, hand, wrist, and fingers. T.M. complained of pain in the right bicep and a knot in the right bicep. At 3:40 p.m., T.M. continued to complain of pain in the right bicep. T.M. was squeezing her right hand and moving her right arm. T.M. was experiencing a prickly sensation to her forearm and hand from the elbow down. The nurse determined that there was a right radial pulse. Dr. Puig was notified of T.M.'s condition. The nurse gave T.M. a bolus of 25 micrograms of Fentanyl; however, the pain medication did not give T.M. any relief. Dr. Puig had given an order for 25 micrograms of Fentanyl to be administered every five-to-15 minutes up to a maximum of 100 micrograms. Fentanyl is a short-acting pain medication. The opiate is more potent that morphine. The effects of Fentanyl will wear off about 20 to 30 minutes after administration. At 3:50 p.m., the nurse administered another bolus of micrograms of Fentanyl to T.M. At 3:54 p.m., T.M was fully flexing and extending her right arm and stated that the second dose of Fentanyl had given her some relief to the pain. At 4:00 p.m., the nurse measured the right arm again. The right bicep was 30 centimeters, and the right forearm was 26.5 centimeters. At 4:07 p.m., T.M. requested more pain medication, and the nurse administered another bolus of 25 micrograms of Fentanyl. T.M. received fair relief from the pain as a result of the pain medication. At 4:25 p.m., T.M. stated that she could feel sensation to her right hand, but was unable to distinguish between sharp and dull pain. She denied the need for further pain medication. At 4:41 p.m., T.M. continued to have pain in her right bicep. She was experiencing numbness and tingling in her right hand and forearm. From the right elbow to her hand, her arm was red, mottled, and petechiae. The right bicep was warm and swollen with thin blisters. The bicep was firm and painful. T.M. requested and was given another 25 micrograms of Fentanyl. At 4:50 p.m., the pain medication had produced only minimal relief from the pain. At 4:53 p.m., T.M. told the PACU nurse that her pain and swelling was not getting any better and that she wanted to be transferred to Tampa General Hospital after she saw Dr. Puig and Dr. Tripathi, who were still in surgery. Dr. Puig and Dr. Tripathi were notified in the operating room. The nurse continued to monitor T.M. T.M. thought that she may have compartment syndrome. Compartment syndrome is a condition that results from increased pressure in the compartment (the muscle surrounded by the fascia), which can lead to lack of perfusion, nerve damage, and eventually to the loss of function of the extremity. It is characterized by pain out of proportion to the nature of the observable injury that will not be alleviated by the administration of narcotic pain medication, swelling, pallor, paraesthesia, lack of pulse, and eventually lack of temperature control. Dr. Puig consulted with Dr. Tripathi throughout the time that T.M. was in PACU concerning T.M.'s right arm. Dr. Tripathi has had training in hand surgery, and, as a surgeon, is familiar with compartment syndrome. Compartment syndrome in the upper arm is a rare event. Neither Dr. Puig, nor Dr. Tripathi, felt that the swelling and pain in T.M.'s arm was due to compartment syndrome. Because of her history with DVT and the similarity of some of the conditions associated with both compartment syndrome and DVT, it was felt that T.M. could have DVT in her upper arm. At 5:00 p.m., Dr. Puig and Dr. Tripathi came to T.M.'s bedside. T.M. was able to flex and extend the right fingers, to perform abduction and adduction of the right fingers, and to extend and flex the right wrist. At 5:30 p.m., Dr. Puig was again at T.M.'s bedside. Ice was applied to the elevated bicep. The circumference of the right bicep was measured and recorded at 33 centimeters. T.M. requested that the PACU nurse call Dr. Kelly O'Keefe at Tampa General Hospital. T.M. spoke to Dr. O'Keefe and advised that she was coming to the emergency room at Tampa General Hospital. Dr. Tripathi and Dr. Puig were aware that T.M. was going to Tampa General Hospital. Dr. Tripathi suggested that an ultrasound be done. At 6:00 p.m., T.M. requested that she been given another dose of Fentanyl to help with the pain while she was traveling to Tampa General Hospital, which was about an hour away from the Central Florida Surgery Center. She was discharged to be transported to Tampa General Hospital by her husband via automobile. At the time of discharge, there was continued swelling and redness of T.M.'s right arm. She was experiencing pain in her right bicep. Her right arm from her elbow to fingers was eccymotic. T.M. presented at the Tampa General Hospital Emergency Department approximately an hour after her discharge from the Central Florida Surgery Center. When she arrived at Tampa General Hospital, her right arm was red and swollen from her elbow to her fingertips. Her motor/sensory function was intact with positive radial and ulnar pulse by Doppler. She was triaged as a semi-urgent patient, Acuity 4. Dr. Kelly O'Keefe examined T.M. and found the following: Extremity/Pain-injury to the RUE, pt underwent surgery today, possible issue with bp cuff right arm during surgery, pt with redness and swelling from elbow joint to finger tips, m/s intact, positive radial pulse and dopplarble [sic] ulnar. Had blepharoplasty and chin tuck done. Pain in left arm is 10/10. Arm is swollen. Forearm with petchia [sic] diffusely, NO SOB, no chest pain. No fever. NO other current complaints. Cuff on about an hour. Prior DVT, off Coumadin now, in leg. NO PE in past. Weakness of hand/wrist associated with pain. Primary symptom. Dr. O'Keefe's differential diagnosis was the following: Evaluate for DVT in upper extremity ?arterial occlusion secondary to cuff without ongoing evidence of arterial blockage, but with likely ischemic neuropathy. Will consult neurology. Doppler scans ordered. Dr. O'Keefe ordered, among other things, a Doppler scan, a complete blood count, a cretatine phosphokinase blood (CPK) study, elevation of the arm, and Fentanyl for pain. He requested consultations with a neurologist and a vascular surgeon. At 7:49 p.m., T.M. was given 100 micrograms of Fentanyl. An ultrasound was performed. After T.M. returned from having an ultrasound done, the nurse noted that T.M. was complaining of pain in her right arm as ten, on a scale of one to ten, with ten being the most painful. There was edema to the right bicep area with stripes of vertical ecchymosis around the entire bicep. The bicep was tender to palpitation and slightly hard to the touch. Petechiae and ecchymosis were noted from elbow to fingertips. The area from the elbow to the fingertips was also edematous, tender to palpitation. Radial and ulnar pulses were detected using a bedside Doppler. There was positive motor/sensory function in the right arm, but slightly weak. T.M.'s right arm was elevated and ice packs were applied. At 9:36 p.m., the neurologist was at bedside with T.M. At 9:42 p.m., Dr. O'Keefe noted that T.M.'s pain and swelling were worsening, which suggested the development of compartment syndrome. At 10:07 p.m., T.M. was given another 100 micrograms of Fentanyl. At 10:45 p.m., T.M. was complaining of pain in her right arm as a ten, on a scale of one to ten. T.M. stated that the Fentanyl was not lasting very long. Dr. O'Keefe was notified, and he ordered one milligram of Dilaudid. At 9:56 p.m., Dr. O'Keefe noted that the Doppler study indicated that there was "[n]o evidence of arterial thrombosis or high grade stenosis," thus, ruling out DVT. The vascular surgeon, Dr. Brad Johnson, saw T.M. at 11:23 p.m. Dr. Johnson was concerned about compartment syndrome. He performed a right upper arm fasciotomy. His discharge diagnosis was right upper-extremity compartment syndrome. As part of his board certification, Dr. Puig is required to comply with the American Society of Anesthesiologists guidelines for anesthesia care. The American Society of Anesthesiologists has developed Standards for Basic Anesthetic Monitoring. The preamble provides: These standards apply to all anesthesia care although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible anesthesiologist. They are intended to encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. They apply to all general anesthetics, regional anesthetics and monitored anesthesia care. This set of standards addresses only the issue of basic anesthetic monitoring, which is one component of anesthesia care. In certain rare or unusual circumstances, 1) some of these methods of monitoring may be clinically impractical, and 2) appropriate use of the described monitoring methods may fail to detect untoward clinical developments. Brief interruptions of continual monitoring may be unavoidable. These standards are not intended for application to the care of the obstetrical patient in labor or in the conduct of pain management. Standard II of the Standards for Basic Anesthetic Monitoring provides: During all anesthetics, the patient's oxygenation, ventilation, circulation and temperature shall be continually evaluated. * * * BODY TEMPERATURE OBJECTIVE To aid in the maintenance of appropriate body temperature during all anesthetics. METHODS Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated or suspected. Loss of large amounts of blood or exposure of body surface was not contemplated for T.M.'s cosmetic surgery. Since T.M. was an adult, was almost completely covered by sheets, and was under a Bair Hugger which supplied forced warm air, Dr. Puig did not feel that T.M. would experience clinically significant changes in body temperature. Dr. Puig controlled the amount of fluids used during the surgery and anticipated the blood loss based on the incisions that would be used by Dr. Tripathi. Dr. Sanchez-Salazar testified as an expert for the Department. Dr. Sanchez-Salazar is a board-certified anesthesiologist. He has been licensed to practice medicine in Florida since 1963. He has been working as a solo practitioner in a stand-alone outpatient surgical facility since 1993. Dr. Sanchez-Salazar testified at the final hearing that he interpreted the temperature-monitoring standards of the American Society of Anesthesiologists to mean that the body temperature of a patient had to be monitored at all times during surgery. He also testified at the final hearing that he does not monitor the patient's temperature during surgeries that last a short period of time. During his deposition taken on August 17, 2010, he testified that he did not monitor patients' temperatures on procedures that lasted an hour or less. He also opined that the monitoring standards of the American Society of Anesthesiologists required that temperatures be monitored when the surgery lasted more than an hour. It is clear that Dr. Sanchez-Salazar did not consider that the monitoring of temperatures should be determined based on whether a clinically significant change in temperature would be intended, anticipated, or suspected. Dr. Sanchez-Salazar's testimony is not credible. Dr. Nikolaus Gravenstein testified as an expert for Dr. Puig. Dr. Gravenstein has been licensed to practice in Florida since 1983. He became board-certified in anesthesiology in 1984 and has continued to voluntarily recertify. He is a professor of anesthesiology at the University of Florida. Dr. Raphael Miguel testified by deposition as an expert for Dr. Puig. Dr. Miguel has been licensed to practice in Florida since 1984. He is board-certified in anesthesiology. Both Dr. Miguel and Dr. Gravenstein opined that based on the American Society of Anesthesiologists standards for monitoring that Dr. Puig was not required to monitor the temperature of T.M. during surgery because there was a low expectation that there would be a clinically significant change in T.M.'s temperature. The testimony of Drs. Miguel and Gravenstein is credited. At the final hearing, Dr. Sanchez-Salazar testified that it was a violation of the standard of care to leave a blood pressure cuff on a patient who is having surgery when the blood pressure cuff is not working and that Dr. Puig violated the standard of care when he left the blood pressure cuff on T.M.'s right arm. When questioned by counsel for Dr. Puig at his deposition taken on August 17, 2010, Dr. Sanchez-Salazar testified that it was not a violation of the standard of care to leave the blood pressure cuff on T.M. However, when Dr. Salazar was questioned by the Department's counsel in the same deposition, he opined that it was a violation of the standard of care to leave the blood pressure cuff on T.M. Dr. Sanchez- Salazar's testimony concerning leaving the blood pressure cuff on T.M. lacks credibility. It is Dr. Gravenstein's opinion that Dr. Puig did not violate the standard of care when he disconnected from the monitoring device, but did not remove the blood pressure cuff from T.M.'s right arm. It is his opinion that most people in the same situation would not remove the blood pressure cuff, because it would be difficult to remove the blood pressure cuff without violating the sterile field. A violation of the sterile field would risk infection of the surgical site. In balancing the need to remove a blood pressure cuff that is not inflated against the need to keep a sterile field, the anesthesiologist should leave the deflated blood pressure in place. Dr. Gravenstein's testimony is credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Puig did not violate section 458.331(1)(t) and dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of March, 2011, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of March, 2011.
The Issue The issue is whether Respondent is guilty of violating the applicable standard of care in the practice of optometry, the prohibition against filing reports or records known to be false, or the prohibition against fraud, deceit, misconduct, or negligence in the practice of optometry.
Findings Of Fact Respondent received his Florida optometry license in October 1982. He earned a doctorate in veterinary parasitology from the University of Florida in 1976 and an optometry doctorate from the New England College of Optometry in 1982. This case involves Respondent's failure to diagnose and treat glaucoma. Glaucoma refers to as many as 87 different types of conditions in which, in most of these conditions, intra-ocular pressure reduces the amount of blood that circulates into the optic nerve. The optic nerve consists of thousands of fibers, each of which transmits from a retinal position--anywhere from central vision to the periphery--to the portion of the brain dedicated to visual processing. Deprived of blood, fibers lose their ability to transmit from the eye to the brain. Traditionally, glaucoma has been associated with high intra-ocular pressure. In the early 1980s, nearly all professionals believed that low- or normal-pressure glaucoma did not exist. However, since the mid-1980s, opthamologists have recognized that about 25 percent of patients suffering from glaucoma do not experience high intra-ocular pressure. Optometrists arrived at the same knowledge a few years later, and general understanding of low- or normal-pressure glaucoma has increased through the 1990s. Persons suffering low- or normal-pressure glaucoma have an optic nerve that is unusually susceptible to damage from intra-ocular pressure. Such persons often display low blood pressure or fluctuating blood pressure. The differential between the greater, though normal or low, intra-ocular pressure and the low blood pressure can impede blood circulation to the optic nerve. Thus, just as persons displaying low intra-ocular pressure may suffer from glaucoma, so persons displaying high intra-ocular pressure may not suffer from glaucoma. Intra-ocular pressure is therefore not an especially definitive indicator of the presence of glaucoma, although high intra-ocular pressure remains a good indicator. The cupping of the optic nerve is another indicator of glaucoma that is not especially definitive. Cupping refers to the indentation of the optic nerve as it enters the eye. Cupping may be due to the response of the optic nerve to intra-ocular tension. However, some persons display physiological cupping, which merely reflects the physical makeup of that patient's optic nerve and does not necessarily indicate any malfunction in the nerve. The older method of determining the extent of cupping required an assessment of the color of the optic nerve. Pink is indicative of healthy tissue, and white is indicative of the cupped area. A newer method of determining the extent of cupping requires an assessment of the extent of bending of the blood vessels, which are indicative of the extent of the bending of the optic nerve fibers, which themselves cannot be seen through their entire bend. One factor that has, at all material times, been a strong risk factor for glaucoma is a family history of glaucoma, especially a maternal genetic predisposition to the disease. Obtaining a history is thus important to an early diagnosis of glaucoma. However, the linkage between high-pressure glaucoma and low- or normal-pressure glaucoma is not especially strong, so family histories, given the failure to recognize low- or normal- pressure glaucoma until recently, often do not reveal the existence of low- or normal-pressure glaucoma. After a genetic predisposition toward glaucoma (and probably more important given the failure of the relevant professional communities to recognize low- and normal-pressure glaucoma until recently), the most important indicator of glaucoma is an impairment of a person's visual field. A visual field test is the most important diagnostic test because it determines the extent to which a person may have suffered a visual loss in any part of his or her visual field. There are different types of visual field tests. The most basic visual field test consists of a mere screening. This is a confrontational field examination in which the optometrist places his or her fingers in the four quadrants of the patient's visual field and asks the patient what he or she can see. This screening has been part of the practice of optometry at all material times. Permitting a more accurate test, the Goldman visual field machine has been available since the early 1980s, although it did not become a standard piece of equipment in optometrists' offices until somewhat later. At present, the Humphrey Perimeter machine is a newer piece of equipment. The basic components of this machine have been available since the early 1980s, but not as long as the Goldman visual field machine. The Humphrey Perimeter machine supplies a light stimulus to different locations within the patient's visual field, and the patient is given a means by which to indicate electronically the location, size, and brightness of the light source. The Humphrey Perimeter machine then maps out the data, so as to provide an easily digestible, graphic display of any deficiencies in a patient's visual field. As apparent in the some of the preceding findings, expertise in the diagnosis of glaucoma has advanced considerably in the past 10 years. At the same time, regulatory and customary restraints upon the ability of optometrists started to lift about 10-15 years ago, as optometrists gained the right to dilate pupils and administer a wide range of prescription drugs, including drugs necessary to treat glaucoma. By the late 1980s, the Humphrey Perimeter machine, or other, similar forms of automated periphery machines, began to appear with regularity in the offices of optometrists. Shortly after entering practice, Respondent, in 1983, purchased the practice of David Johnson, an opthamologist. Dr. Johnson's office was located in Brooksville, which is where Respondent has maintained his practice of optometry. From the date of the purchase until sometime in 1985, Dr. Johnson practiced on a consultative basis in Respondent's office. Respondent examined R. L., who was born in 1940 or 1941, four times: November 6, 1984; June 17, 1987; October 18, 1989; and October 11, 1990. At the first, as well as the other three, office visits, an assistant performed the confrontational field screening to assess R. L.'s visual field. These tests disclosed nothing abnormal. During the first and ensuing visits, an assistant or Respondent tested R. L.'s intra-ocular pressure. These tests disclosed nothing abnormal. The notes from the first office visit state that there was no family history of eye problems. During the first visit, Respondent examined R. L.'s eyes and found a possible abnormality--cupping--in the appearance of the patient's optic nerves. Dr. Johnson was in the office at the time, so Respondent asked Dr. Johnson to examine R. L., who had previously been Dr. Johnson's patient. Dr. Johnson examined R. L. and determined that his optic nerves were normal. At the conclusion of the first visit, Respondent discussed with R. L. the cupped appearance of his optic nerve. Respondent showed R. L. intra-ocular photographs of his optic nerve and a normal optic nerve and told R. L. that his cupping was physiological. R. L. testified that he did not feel that Respondent necessarily should have detected the glaucoma until the third visit. At the second and third office visits, Respondent found that the extent of cupping had remained substantially unchanged. At the second office visit, though, R. L. reported that his mother had suffered from glaucoma. The office records reveal that his blood pressure was 108/62, which is somewhat low. By the third office visit, Respondent had purchased an automated perimeter machine for use in his office. Respondent suggested that R. L. undergo a visual field test using this machine on each of the last two visits. However, R. L. refused to do so. At the end of the third and fourth office visits, Respondent suggested that R. L. see an opthamologist, but R. L. declined to do so after the third office visit. A few days after the fourth visit, evidently following Respondent's recommendation, R. L. visited an opthamologist for an examination. In performing his examination, the opthamologist discovered that R. L. had advanced glaucoma. R. L. has since undergone glaucoma surgery to relieve intra-ocular pressure. His vision is impaired. Although an earlier diagnosis probably would have slowed the deterioration in his vision, it would not have altered the eventual outcome of the disease, which is continued deterioration in vision. The evidence is decidedly vague concerning the applicable standard of care in Brooksville, or even in Florida, at the time of each of the four office visits from 1984-1990. This was a period characterized by many changes in the understanding of glaucoma by the optometric community, as well as the opthamologic community, and by the distribution of automated perimeter equipment, which facilitates sophisticated visual field testing. Obviously, the difficulty in establishing the applicable standards of care is heightened by the fact that 9-15 years passed, following the office visits, before Petitioner referred this case to the Division of Administrative Hearings. Neither the opthamologic nor the optometric community was widely aware of the existence of low- or normal-pressure glaucoma until after the first visit. The optometric community did not become aware of the existence of this form of glaucoma until after the expiration of this six-year period. At the time of the first three visits, Respondent met the standard of care applicable to optometrists in Florida, and certainly in Brooksville, by having his staff conduct confrontation visual field examinations, testing intra-ocular pressure, and monitoring the cupping to ensure that it did not worsen. Although the cupping was relatively severe at the time of the first visit, so that it could not deteriorate significantly, Respondent had properly obtained the diagnosis of an opthamologist, who had previously cared for R. L., to support Respondent's conclusion that the cupping was merely physiological in origin. At no time did Respondent's diagnostic efforts deviate from the applicable standard of care. His acquisition of automated perimeter equipment was early for the Brooksville optometric community, and the record does not establish that the Florida optometric community widely acquired such equipment any earlier, or even at the time that Respondent did. Respondent properly suggested to R. L. during the third and fourth visits that R. L. undergo more sophisticated visual field testing, as Respondent was eager to put his new equipment to use, but R. L. declined to undergo the procedure because he felt that it was unnecessary. Likewise, Respondent properly suggested to R. L. during the third and fourth visits that R. L. see an opthamologist, but R. L. declined to do so. Respondent's records are austere, but Petitioner has failed to prove by clear and convincing evidence that Respondent did not adequately record the course of his care of R. L. The better practice would have suggested more detailed records and more detailed records prepared contemporaneous to the dates of care. However, the omissions did not establish by clear and convincing evidence a violation of the recordkeeping requirements, nor did any late entries establish by clear and convincing evidence an intent to deceive. Lastly, Respondent underwent a deposition in a civil action for damages that R. L. brought against him. The plaintiff's attorney asked Respondent: "[Have you ever had] [c]omplaints of any kind of department of regulation of any kind?" Respondent responded by asking, "From a patient or anything?" The attorney answered, "Yes." And Respondent replied, "Not that I am aware of." Respondent has been disciplined twice in the past. However, both of these situations involved Petitioner-initiated charges, which were not based on complaints from actual patients of Respondent. Petitioner has thus failed to prove by clear and convincing evidence that Respondent committed fraud or deceit in the practice of optometry by answering this vague question in the negative. It is at least as likely as not that Respondent's use of "or anything" in his responsive question meant only to restate the notion that his answer would be limited to patient-initiated charges.
Recommendation It is RECOMMENDED that the Board of Optometry enter a final order dismissing the Administrative Complaint, as amended, against Respondent. DONE AND ENTERED this 15th day of December, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 15th day of December, 1999. COPIES FURNISHED: Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Eric G. Walker, Executive Director Board of Optometry Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792 Thomas E. Wright, Senior Attorney Agency for Health Care Administration General Counsel's Office Medical Quality Assurance, Allied Health Post Office Box 14229 Tallahassee, Florida 32317-4229 William B. Taylor, IV Macfarlane Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Petitioner's Injury At all times, the Petitioner has been employed as a Ladies Wear Department Manager for K-Mart Corporation. On July 21, 1998, Petitioner, while in the course and scope of her employment, was injured when she fell on a metal ladder as she attempted to hang clothes on a rail. Her left knee struck a metal bar on the second step of the ladder, causing immediate pain. On August 26, 1998, Petitioner consulted Dr. Jeffery Friedman, M.D., an orthopedic surgeon, who specializes in knee and shoulder surgery. Dr. Friedman was recognized as an expert in the field of orthopedic surgery. On or about September 4, 1998, Petitioner underwent arthroscopic surgery performed by Dr. Friedman to remove a loose body from the knee. Dr. Friedman found grade III chondromalacia and debrided the area using an arthroscopic shaver. He also found loose articular cartilage at the patella. Dr. Friedman's records describe the area of grade III chondromalacia as "fairly large" and involving " the apex of the patella." However, neither the size nor the shape of the injury is disclosed. Dr. Friedman also debrided flake of articular cartilage from the tibial plateau and removed a calcific loose body from the posteromedial compartment. His post-operative diagnosis was left knee loose body, chrondromalacia, and intracruciate ligament strain. Petitioner returned to work with K-Mart after the arthroscopic surgery, and was placed on light duty. While performing her duties, Petitioner is required to stand most of the time, and is unable to sit. Prior to her injury, Petitioner worked 40 hours per week. After her injury, due to her physical limitations resulting from the accident, Petitioner is only able to work 24 hours per week. Petitioner's pain limits her ability to work 40 hours per week. Petitioner cannot put her full weight down on the left knee while going up steps or a ladder or it causes sharp shooting pains. In addition, continuous walking results in continuous aching pain. The reduction in Petitioner's work hours was due to her injury. Petitioner is now unable to perform all of the duties that were required of her before the injury. Dr. Friedman found Petitioner to have reached maximum medical improvement in December 1998. In early 1999, Petitioner sought treatment for continued pain. An MRI was performed on or about March 5, 1999, which suggested a small defect in the articular cartilage, thinning of the patellar cartilage, and narrowing of the medical femoral tibial joint consistent with the early stages of osteoarthritis. In June, 1999, Petitioner underwent steroid injections for continued pain. In September, 1999, Petitioner returned to Dr, Friedman because of continued pain. Dr. Friedman reviewed a video tape that he had made of the arthroscopic surgery and fount that the Petitioner had a fairly large chondral defect of the patella. Dr. Friedman determined that Petitioner was a candidate for ACI, also known as the Genzyme Carticel Procedure (Genzyme Procedure). Dr. Friedman believed that the ACI procedure would benefit Petitioner by providing long-term symptomatic relief with joint pain and mechanical disturbances and improved joint motion function, eliminating the complaints of grinding and catching, and furthering the goal of returning the patient to regular and even strenuous activity. Petitioner then requested authorization for the ACI procedure. The Employer/Carrier denied the request and referred it to the Agency for Health Care Administration for review in accordance with Florida law. The Agency consulted with the University of Florida Faculty Practice Group, and Dr. B. Hudson Berrey, Chair of the Department of Orthopaedics and Rehabilitation, rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. Dr. Berrey further opined that there was not reliable evidence that ACI would provide significant benefit to the recovery and well-being of the injured employee within the meaning of Rule 59B-11.004(3), Florida Administrative Code. The documents and information forwarded to Dr. Berrey by Respondent included Petitioner's medical records provided by Intervenor, K-Mart carrier. Dr. Berrey did not review any actual MRI films, did not review any films taken at the time of the arthroscopic procedure, and in fact only reviewed certain documentation that was supplied to him by the agency. Petitioner was denied her right to present information to Dr. Berrey prior to his forming his opinion for the agency. This was a violation of Rule 59B-11.003, Florida Administrative Code. The agency rendered a decision based upon Dr. Berrey's opinion, declining to order the Employer/Carrier to provide ACI to Petitioner. Autologous Chondrocyte Implantation The ACI procedure was initially developed in Sweden by Dr. Lars Peterson. ACI is a surgical procedure whereby a sample of cartilage is harvested from another area of the joint. The harvesting of the cartilage is performed during an arthroscopic surgical operation. The sample is sent to Boston to the laboratory of Genzyme Tissue Repair, Inc. ("Genzyme"), the owner of the process. Genzyme uses its proprietary process to culture the cells into an estimated 12 million chondrocytes over a period of approximately two months. Genzyme then returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted on the wounded cartilage and covered with the periosteal flap. The ACI procedure thus requires two surgical operations, one arthroscopic procedure and one open procedure. The claimed benefit of ACI is that the cartilage that is generated and implanted onto the knee will be hyaline cartilage or hyaline-like cartilage rather than fibrocartilage. Hyaline cartilage is composed both of the cartilage cells of an extra-cellular matrix. It has greater ability than fibrocartilage to withstand compression and shearing forces. ACI has been shown to produce "hyaline-like" cartilage in some patients. However, it does not reproduce the extra- cellular matrix in which the chondrocytes are found in naturally occurring hyaline cartilage. Alternative Treatments Other available treatments for a defect in articular cartilage of the knees include abrasion chondroplasty, arthroscopic microfracture, and arthroscopic drilling. Many patients get relief with one or more of these alternative procedures and do not need another operation. In addition, a surgical procedure to elevate the tibial tubercle and remove some of the weight from the patella might also alleviate the Petitioner's pain and improve her functioning. Dr. Friedman performed an abrasion chondroplasty during the arthroscopic surgery of September 4, 1998. Dr. Friedman did not offer Petitioner either the microfracture or the drilling procedures. Dr. Friedman had considered performing a tibial tubercle elevation but has not recommended that the Petitioner undergo that procedure either before the ACI is approved or independently of the ACI. Dr. Friedman views the primary purpose of this procedure as assuring the best possible results from the ACI. Dr. Friedman indicated there were no appropriate alternative medical procedures, other then the ACI procedure, available for Petitioner's injury. Dr. Friedman opined that the only viable option of putting back normal articular cartilage underneath the kneecap would be with the ACI procedure. In this opinion, the alternative procedures are not appropriate for and would not benefit Petitioner, as they were merely temporary procedures. Moreover, he emphatically stated that the ACI procedure is the procedure which is appropriate for an would benefit Petitioner. The Evidence That ACI Remains Investigative The Agency for Health Care Administration has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Sections 440.13(15) or 408.02, Florida Statutes; therefore, there was no Agency-approved protocol for Dr. Berrey to consider in rendering his opinion. Dr. Berrey testified that he could find no articles or publications describing controlled studies in which the effectiveness of ACI compared to any other procedure. Dr. Berrey further testified that he could find no articles about the ACI procedure in peer-reviewed journals in which the authors used objective measures of outcome which compared the patients' condition before and after treatment. The use of blinded or controlled studies is important so that possible confounding factors or variables can be controlled or accounted for and the results measured objectively. Dr. Berrey found that the publications cited by the proponents of the procedure discussed research which was funded by Genzyme, the owner of the process by which the chondrocytes were cultured. The funding of the research by the owner of the process was an additional factor in his determination that the evidence supporting the efficacy of the procedure was not reliable. The Cartilage Repair Registry and the results reported therein do not constitute reliable evidence of the benefits of ACI when compared to other available procedures for two reasons. First, the potentially confounding variables are neither controlled nor accounted for. Second, each surgeon evaluates his or her own work, so that there is no objective, independent measurement or assessment of the condition of each patient before and after surgery. Although the premise on which ACI is based is that the patient's implant will consist of hyaline cartilage rather than fibrocartilage, the available data does not indicate that the results are comprised only, or even primarily, of genuine hyaline cartilage. Rather, the evidence is that some patients develop "hyaline-like" cartilage, or cartilage composed partly of hyaline tissue. It cannot be determined whether hyaline or hyaline- like cartilage has filled a patient's defect without performing a biopsy and a histological evaluation of the tissue. The published reports described in the testimony contain discussions of post-surgical histological performed on very small numbers of patients. The published reports concerning the use of ACI to treat defects of the patella show that the results are not as favorable as those claimed for treatment of the femoral condyle. After the proponents of the procedure began to perform other procedures with the ACI to assure that any defects in the alignment of the patella are repaired, improved results were reported. Dr, Friedman testified about the published results of histological evaluations of 37 patients. Of those, seven underwent ACI to treat defects of the patella. Only one of the seven showed the development of hyaline-like tissue. Further, only two of the seven patella patients reported surgical results classified as good or better. Dr. Friedman opined that the histological data resulting from treatment of defects of the patella had improved since the study described in the preceding paragraph. However, he could not give any reference to the basis for his opinion. Dr. Friedman further testified that the more recent articles discussed the results of patients who had been followed from nine to 15 years. However, the articles and presentations from 1997 to 2000 report on follow-up of the first hundred patients between two and nine years after their surgery. Dr. Billings testified that Dr. Peterson's presentation discussed follow-ups of ACI patients occurring as long as 15 years after surgery. Yet, the March 2000 presentation to the American Academy of Orthopedic Surgeons focused on 40 patients who had been evaluated three or more years after their surgery. The FDA granted an accelerated approval of the Carticel product in 1997. The original accelerated FDA approval was granted for defects of the femoral condyle, the trochlear groove, and the patella. The terms of the approval require that controlled studies be conducted which compare the procedure to other procedures available for the treatment of focal chondral defects, specifically, microfracture and the creation of a periosteal flap without the injection of the cultured chondrocytes. None of the expert witnesses had found in their literature search any published reports of the progress of the controlled studies required under the terms of the accelerated FDA approval. In February, 2000, the FDA approval was modified. Genzyme is no longer permitted to market the ACI procedure or its Carticel product for treatment of defects to the patella. The requirements of Rule 59B-11.004, Florida Administrative Code, differ significantly from those of the accelerated FDA approval process, so that the granting of accelerated approval does not determine the answer to the question whether a treatment is investigative under that rule. The FDA's inquiry addresses the issues of safety and efficacy. However, the accelerated FDA approval process does not address the issues of whether a particular product is more effective than currently existing treatments or is equally cost-effective. Based upon all the evidence, the performance of the ACI procedure on the defects located in the patella is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. The Probability That ACI Would be of Significant Benefit in Returning Petitioner to Work Both of Petitioner's expert witnesses testified that if she does not undergo ACI, it is likely that she will need a total knee replacement. However, neither witness testified that Petitioner currently requires a total knee replacement. No testimony was presented as to when Petitioner might require a total knee replacement. Despite the testimony that ACI has been studied for 20 years, the published reports follow patients only for nine years after surgery. From the current state of the research, it is not possible to conclude that patients who undergo ACI avoid the need for subsequent surgery in ten or more years. The published studies of the results of ACI going out nine years from the date of surgery do not state the number of procedures performed on the patella. No witnesses testified regarding any published studies of the effectiveness of ACI that addressed the extent to which patients had been able to return to work as a result of the procedure. There is insufficient evidence from which to conclude that the ACI is more likely to enable the Petitioner to return to her duties that other available procedures. The Likelihood That the Benefits of ACI Would Outweigh the Risks and the Costs The testimony compared the cost and benefit of ACI with chondroplasty, microfracture or drilling, and, to some extent, a Macquet procedure or tibial tubercle elevation. Each of the other procedures requires only one surgical operation. ACI requires an arthroscopic surgical procedure to harvest cartilage, culturing of the chondrocytes at the Genzyme laboratory in Boston, and followed by an open surgical procedure to create a periosteal flap and to implant the chondrocytes. Petitioner's expert testified that the cost of culturing the chondrocytes alone was between $8,000 and $10,000, in addition to the two surgical procedures. Petitioner's expert compared the cost of ACI to that of a total knee replacement. However, that comparison is not appropriate under the rule because there is no evidence that Petitioner currently needs a knee replacement or that a knee replacement is the treatment generally used to treat her current condition. The cost of the abrasion chondroplasty, the microfracture or drilling procedure would approximate the cost of the first stage of ACI, approximately $2,300. Dr. Billings testified that the cost of the second stage of ACI was greater than that of the first stage. The second stage is an open surgical operation rather than an arthroscopic one. The total cost of the ACI procedure, including therapy, is probably close to the $30,000 required for a total knee replacement, including the therapy required for the total knee replacement. Dr. Berrey testified that published reports of the cost of ACI are as high as $37,000. The ACI requires extensive physical therapy; Petitioner presented no evidence as to the extent to which the cost of this aspect of treatment was included in the total cost of ACI. ACI has been established to be safe, so that the benefits of the procedure outweigh the risks. However, there is insufficient evidence from which to conclude that the benefits of ACI outweigh the additional costs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying approval of the autologous chondrocyte implantation for Petitioner Rebecca Crane. DONE AND ENTERED this 27th day of November, 2000, 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 27th day of November, 2000. COPIES FURNISHED: Jeffrey J. Bordulis, Esquire 570 Crown Oak Centre Drive Longwood, Florida 32750 Lisa J. Hurley, Esquire Pyle, Jones, Hurley & Hand, P.A. 1069 West Morse Boulevard Winter Park, Florida 32789 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
