Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as the facts stipulated to by the parties, the following relevant facts are found: Petitioner Frank Robert Gentile was born in New York on August 14, 1942, and is a citizen of this country. He attended St. John's Preparatory School in New York from 1956 through 1960, and received his undergraduate degree from Seton Hall University in New Jersey in 1964. His medical degree was received from the University of Bolgona, Bolgona, Italy, in 1972. In 1973, petitioner's credentials were evaluated by the Educational Commission for Foreign Medical Graduates and he received a passing grade on the examination administered by that organization. Between July, 1972 and June, 1973, petitioner trained as a clinical clerk at Maimonides Medical Center and Wyckoff Heights Hospital in Brooklyn, New York. From July, 1973 through January, 1974, petitioner completed his medical externship at the Veteran's Administration Hospital in Brooklyn, New York. From January, 1974 through January, 1975, petitioner completed an approved internship at Jersey Shore Medical Center in Neptune, New Jersey. From July, 1975 through June, 1978, petitioner completed his residency at Methodist Hospital in Brooklyn, New York. Petitioner received a passing grade in the examination administered by the Federation of State Medical Boards of the United States, Inc. (FLEX) in September of 1977. From July, 1978 through June, 1979, petitioner trained as a Hematology Fellow I at Cabrini Medical Center, New York, New York. From July, 1979 through June, 1980, petitioner trained as a Hematology Fellow II at Downstate Medical Center-Kings County Hospital Center in Brooklyn, New York. From July, 1980 through June, 1981, petitioner trained as a Medical Oncology Fellow at Downstate Medical Center-Kings County Hospital Center in Brooklyn, New York. Petitioner has been continuously and actively engaged in the practice of medicine, specializing in the fields of hematology and oncology, from June, 1981 to the present. Petitioner currently holds licenses to practice medicine in the states of New York and North Carolina. These licenses are in good standing, have never been revoked or suspended and petitioner is not under investigation in either state. From July, 1981 through January, 1982, petitioner was employed by Memorial Hospital of Alamance County, Burlington, North Carolina, as a hematologist and oncologist. He considered this employment to be temporary and so informed the Chief of Staff. While at Memorial Hospital, petitioner treated patients, did consultations and trained the oncology nurse. During the first part of his work there, his patients and charts were reviewed by a panel of doctors. He never received any complaints from his patients or from his fellow physicians concerning his medical skills. The Medical Staff Bylaws required a six-month review. In January, 1982, petitioner was informed by the Chief of Medicine that the review board had met, that petitioner's charts were not complete enough and that the board felt that petitioner should immediately resign from the Hospital. When petitioner inquired as to the problems the board found with respect to his charts, he was not given a specific answer. Petitioner received no prior warning and he considered his charts acceptable. Rather than contesting the charges against him, petitioner resigned from Memorial Hospital inasmuch as he had no intention of remaining there on a permanent basis. On March 17, 1982, petitioner applied to the Florida Board of Medical Examiners for licensure by endorsement pursuant to Section 458.313, Florida Statutes (1981). His application was complete in all respects and was accompanied by the required application fee. During the application process, petitioner was requested to furnish additional information as to what he was doing from June, 1981 to the present. He responded that he had finished his training near the end of June and then had been trying to find a place to start a private practice. He further explained that he took over a doctor's practice while that doctor was on vacation and that he had worked in the emergency rooms in the North Carolina area. No mention was made by respondent of his employment with the Memorial Hospital of Alamance County. Upon a standard inquiry to the North Carolina State Board of Medical Examiners, the respondent board learned of petitioner's affiliation with the Memorial Hospital of Alamance County. That Hospital was requested to complete a form regarding petitioner. The form was completed by "Susan Denault, Assistant Administrator," and was returned to the respondent and placed in petitioner's application file. To the question "Does he perform competently?" the answer "Questionable" appears on the form. To the question "Have any restrictions ever been placed on him beyond the original period of probation?" the following answer appears: On January 18, 1982, the Department of Medicine reviewed the work of Dr. Frank R. Gentile acting in accordance with the Medical Staff Bylaws, Rules and Regula- tions which require a six-months review. At that meeting the Department of Medicine decided the work of Dr. Frank R. Gentile had not been up to the standards expected by the department, and was not in accordance with that standard that should be appropriate for practice in the Memorial Hospital of Alamance County. Before further action could be taken, Dr. Frank R. Gentile voluntarily resigned his membership and clinical privileges to the Medical Staff of Memorial Hospital of Alamance County, Inc. Dorothy Faircloth, the Executive Director of the Florida Board of Medical Examiners, in response to petitioner's inquiry as to the status of his application, informed petitioner that the Board had received the form from the Memorial Hospital of Alamance County and related the contents to him. She advised petitioner that the normal procedure of her office was to request further information from an institution providing such information and also to request the applicant to provide a written response to such a report. However, petitioner indicated that he wished to personally address the Board on this matter at its upcoming Board meeting. Petitioner did appear at the Board meeting but felt that the Memorial Hospital matter was not fully addressed by the Board and that he was not given the opportunity to speak to the Board on that matter. By Order dated June 24, 1982, the Board of Medical Examiners denied petitioner's application for licensure by endorsement, finding that The Petitioner has not demonstrated to the Board that he is capable of safely engaging in the practice of medicine with reasonable skill and safety to his patients based upon his voluntary resignation of his membership and clinical privileges at Memorial Hospital of Alamance County, Inc., Burlington, North Carolina, just prior to disciplinary action taken by the hospital. Based on this finding, the Board concluded that petitioner had not demonstrated that he meets the statutory requirements of Sections 458.313 and 458.331(3), Florida Statutes.
Recommendation Based upon the findings of fact and conclusions of law recited above, it is RECOMMENDED that petitioner's application for licensure by endorsement be GRANTED. Respectfully submitted and entered this 17th day of January, 1983, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of January, 1983. COPIES FURNISHED: Edward P. de la Parte, Jr., Esquire de la Parte & Gilbert 705 East Kennedy Boulevard Tampa, Florida 33602 Chris D. Rolle, Esquire Assistant Attorney General Department of Legal Affairs Suite 1602, Capitol Tallahassee, Florida 32301 Dorothy Faircloth Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS FRANK ROBERT GENTILE, M.D. Petitioner, vs. DOAH CASE NO. 82-1994 DEPARTMENT OF PROFESSIONAL REGULATION and BOARD OF MEDICAL EXAMINERS, Respondent. /
Findings Of Fact At all times material hereto, Respondent has been licensed to practice medicine in the State of Florida, having been issued license number ME-0027913, and was employed by the Norton Seminole Medical Group in Pinellas County, Florida. Respondent has been licensed in Florida since 1976. At approximately 3:50 p.m. on November 1, 1983, a 31 year old white male, with the initials R. L., arrived at the emergency room of Lake Seminole Hospital, Seminole, Florida, and was examined by the emergency room physician on duty. R. L. complained of substernal mid-chest pain radiating to his back, which had begun the night before. He was agitated and exhibited a great deal of emotional stress. The emergency room physician on duty treated R. L. for suspected cardiac pathology, placed him on a cardiac monitor, inserted a heparin lock into a vein, and ordered lab work which included a chest x-ray, electrocardiogram, electrolytes, cardiac enzymes, CBC (complete blood count), blood sugar, creatinine and BUN (blood urea nitrogen). These were appropriate tests under the circumstances. When the Respondent came on duty in the emergency room at 7:00 p.m., all lab work had been completed, except for the cardiac enzymes. The emergency room physician who had been on duty when R. L. appeared at the emergency room briefed Respondent about R. L.'s medical history, condition while in the emergency room, and the test results which had been received. After the cardiac enzyme values were received, Respondent reviewed R. L.'s medical history and lab test results, which he determined to be normal, and discharged R. L. at approximately 7:35 p.m. on November 1, 1983, with instructions that he see his family physician the next morning. Respondent's discharge diagnosis for R. L. was atypical chest pain secondary to anxiety. At approximately 11:21 p.m. on November 1, 1983, R. L. expired from cardiopulmonary arrest at the emergency room of Metropolitan Hospital, Pinellas Park, Florida. The autopsy report notes extensive coronary artery disease, but makes no mention of acute myocardial infarction. It was not established by clear and convincing evidence that R. L. suffered an acute myocardial infarction. There is conflicting expert testimony from Steven R Newman, M.D., and Stephen J. Dresnick, M.D., concerning whether Respondent should have admitted R. L. to Lake Seminole Hospital instead of discharging him from the emergency room, and also whether his E.K.G. taken at the emergency room was normal. Drs. Newman and Dresnick are experts in the care and treatment of patients in an emergency room, but their testimony was received by deposition instead of through live testimony at hearing. Thus, based upon this conflict in testimony, and the fact that the demeanor of these witnesses cannot be assessed, it is found that it was not established by clear and convincing evidence that Respondent failed to practice medicine with that level of care and skill which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances when he discharged R. L., and evaluated the tests which were administered to the patient while in the emergency room as within normal limits. A patient who appears at a hospital emergency room with unstable angina, such as R. L., does not necessarily require admission to the hospital. While serial electrocardiograms and serial cardiac enzymes are called for with patients whose symptoms of cardiac discomfort warrant hospitalization, these procedures are not usually and customarily performed in an emergency room. Therefore, since it was not established that Respondent should have admitted R. L. to the hospital as an in-patient, it was also not established that he failed to exercise the required level of skill and care by failing to order such serial tests while R. L. was in the emergency room. Although the emergency room physician on duty when R. L. arrived at the emergency room at approximately 3:50 p.m. on November 1, 1983, was initially responsible for obtaining a patient history and ordering the tests which were performed, when Respondent came on duty at 7:00 p.m. and took over this case, he was also responsible for insuring that his medical records concerning his evaluation and treatment of R. L., as well as his decision to discharge the patient, were full and complete. Respondent failed to document his review and findings based upon the lab tests and chest x-ray which had been completed, as well as the patient's medical history, and the specific reason or basis for his decision to discharge R. L. Respondent relied almost completely on the medical records compiled by the emergency room physician who was initially on duty when R. L. arrived at the emergency room, and made no significant additions to those records while the patient was under his care, or which would justify his course of treatment, including discharge, of this patient.
Recommendation Based upon the foregoing, it is recommended that the Board of Medicine enter a Final Order reprimanding Respondent for his violation of Section 458.331(1)(m), Florida Statutes, and placing him on probation for a period of six months from the entry of the Final Order in this case, conditioned upon his complying with such reasonable terms and conditions as the Board may impose, including review and verification of the completeness of medical records prepared by the Respondent while on probation. DONE AND ENTERED this 5th day of July, 1990 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 5th day of July, 1990. APPENDIX (DOAH CASE NO. 89-6874) Rulings on the Department's Proposed Findings of Fact: 1-2. Adopted in Finding of Fact 1. 3-4. Adopted in Finding of Fact 2. 5-6. Adopted in Finding of Fact 3. 7. Adopted in Finding of Fact 4. 8-9. Rejected in Finding of Fact 5. 10. Rejected in Finding of Fact 4. 11-12 Rejected in Finding of Fact 6. 13. Adopted in part in Finding of Fact Rejected in Findings 5 and 6. 7, but otherwise Rulings on the Respondent's Proposed Findings of Fact: Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2 and 3. 4-5. Adopted in Finding of Fact 2. 6. Adopted in Finding of Fact 3. 7-9. Adopted in Finding of Fact 4. Rejected in Finding of Fact 5. Rejected in Finding of Fact 7. 12-13. Adopted in Finding of Fact 6. Adopted in part in Finding of Fact 2, but otherwise Rejected in Finding of Fact 5. Adopted in Finding of Fact 5. Rejected in Finding of Fact 7. COPIES FURNISHED: Andrea Bateman, Esquire Kevin F. Dugan, Esquire 1940 North Monroe Street Wittner Centre West Suite 60 Suite 103 Tallahassee, FL 32399-0792 5999 Central Avenue St. Petersburg, FL 33710 Kenneth E. Easley, Esquire General Counsel 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact Respondent, Mary-Claire Chapman, M.D. (Dr. Chapman) is now, and at all relevant times was licensed as a physician in the State of Florida, having been issued license number ME 0049241. From May 1989 until May 1992, Dr. Chapman was the chief health officer at Charlotte Correctional Institution (CCI), a prison in the Florida correctional system, in Punta Gorda, Florida. Patient A.J. Inmate A.J. arrived at CCI on August 9, 1989, with no apparent medical complaints. From August 1989, until March 1990, he attended sick call or clinic with complaints related primarily to digestive disorders; the treatment given to him during that period is not at issue. A.J.'s first noted complaints of headaches was on March 8, 1990, when he was seen at Doctor's Clinic at CCI by staff physician, Dr. DeCespedes. He was given Motrin. On March 10, A.J. completed an inmate medical request seeking to have his eyes checked as he stated he was getting daily headaches for three weeks. He was seen in sick call on March 12, with complaint of "severe migraine headache" for two weeks. He was given Motrin and was referred to the senior nurse, who saw him on March 13. The nurse noted his complaint of severe pounding headache and stuffy nose and ears "like on an airplane". He was given Dimetapp and Ibuprofen. A.J. appeared at sick call again on March 16 complaining of headaches that affected his vision. He was referred by the nurse to Dr. DeCespedes, who examined him and noted no acute distress, supple neck and 20/20 vision. Dr. DeCespedes gave him Ibuprofen and suggested return in ten days for follow up. On March 18, A.J. completed an inmate request form to medical: Doc I have been having headakes real bad ones, every day for three weeks now. On 3/17/90 I started to have trouble seeing. I can not fockus with both eyes open but can with one open at atime. Can you pleas help me quickely. thank you (Pet. Ex. #1, p. 15) The form is stamped received on March 19, 1990, "Medical, Charlotte Correctional Institution". That same date A.J. sent an "emergency grievance" to the assistant superintendent stating that the pain was very bad, that he was walking into things and stating that he needed medical assistance as soon as possible. Dr. Chapman examined A.J. on March 20; fundoscopy, temperature and neck movements were normal. Dimetapp was given, and a staff optometry appointment was scheduled for April 2. The staff optometrist examined A.J. and found no problems with his retina or vision but ordered glasses to help with the focusing. The optometry note in A.J.'s medical record states that the patient needs to be reevaluated by the M.D. because of the headaches. A.J. saw the nurse in the clinic on April 8 with complaints of continued, unchanged headache. He was given Ibuprofen and an appointment to see the doctor on April 10. Dr. DeCespedes' notes of examination on April 10 reflect normal findings and an order of an X-ray for sinuses. The X-rays, taken on April 12, reflected sinusitis. Dr. Chapman reviewed the file on April 10 and April 13; she found the work-up for headaches adequate and ordered Keflex for the sinusitis. Dr. Chapman examined A.J. at the clinic on April 17, when he reported feeling bad and unable to go to work. He refused a "lay-in" because he did not want to lose gain time and said, "my boss understands." The examination revealed normal findings. Dr. Chapman added Dimetapp to the Keflex already being taken and advised A.J. to keep his follow-up appointment with Dr. DeCespedes. A.J. appeared at the clinic several time on April 24. In the morning he reported, "I think I'm dying", stated his headache was much worse, held one eyelid half-shut and complained of blurred vision, tinnitis and photophobia. He said his sinuses no longer caused pain. The nurse gave him Ibuprofen and told him he had a doctor's appointment on the next day. The nurse noted he had lost 22 pounds since the end of November and 31 pounds since August. That same day, later in the afternoon A.J. reported to the clinic again, stating that he had gotten up to get a drink of water, blacked out and came to with someone holding him up. He said the Motrin provided no relief from his severe headache. His throat was slightly inflamed with some swelling on the right side. He was referred to the staff physician who observed the patient in distress and hyperventilating. He was given Darvocet; Dr. DeCespedes was consulted; and another sinus X-ray was ordered. On April 26, Dr. DeCespedes admitted A.J. to the infirmary after he had reportedly passed out in his bunk. The sinus X-rays reflected the sinusitis was resolved. From April 26 through April 30, A.J. continued to complain of headaches and loss of vision. A CT scan and bloodwork were ordered. Nursing notes from the infirmary reflect that A.J. was "looking" at TV with no apparent blindness. He was examined on April 30, by Dr. DeCespedes and by the optometrist, who found abnormal fundi (swelling of the optic nerve). The optometrist recommended an opthomologist (MD) consultation as soon as possible. Dr. Chapman examined A.J. at 6 p.m. on May 1. By then he was lethargic, unable to get up without assistance and had difficulty swallowing. Dr. Chapman noted the swelling of the optic nerve and ordered A.J. transferred to the local hospital. Laboratory work on admission showed elevated white blood count which had not been revealed in laboratory findings earlier. Other tests, CT scan and MRI, were initially normal, but brain edema appeared after the third day. Similarly, spinal taps indicated elevated spinal fluid which was clear at first, but, after the fourth hospital day tested positive for streptococcus. The diagnosis after several days was cryptococcal meningoencephalitis. A.J. lapsed into a coma and died at the hospital on May 8, 1990. Patient J. D. J. D., aged fifty-one, entered the Florida Department of Corrections system at the South Florida Reception Center on January 30, 1990. He had a history of peripheral vascular disease (PVD), diabetes and hypertension, and had undergone vascular surgery. In February 1990, under the auspices of the Department of Corrections, J.D. underwent further surgery to repair a prior graft. The patient had a bypass graft performed from the left groin to the right groin using an interposition graft at the left common femoral position, and a 6mm cross-over graft placed from the interposition graft to the right superficial femoral artery. J. D. was transferred to CCI around May 2, 1990. On arrival, he was evaluated by staff physician, Dr. DeCespedes, who noted his history, including the recent surgery. He was given a pass for no prolonged standing, was placed on a low cholesterol diet and was given a lower bunk assignment. Thereafter, J.D. was reevaluated by the staff physician on May 16, 1990; July 10, 1990; October 23, 1990; and February 21, 1991. February 21, 1991, is the first day that a complaint of pain by the inmate was noted. On February 21, 1991, Dr. DeCespedes' clinic notes reflect complaint of pain in J. D.'s legs and a mass in the left inguinal area. Dr. DeCespedes gave J.D. a light duty pass for a few days. On March 5, 1991, J.D. sent this inmate request to Dr. Chapman: Dr.Chapman. I am in the need of help. I have hardening and blood clots in the arteries. I had surgery at So. Fla. Reception in Feb. of last yr. at Larkin Hospital. For the past month I have been experiencing severe pain in my legs. More in the right leg and foot than the left. I saw Dr. DeCespedes last week and told her of the pain and numbness. I also told her that I was having trouble walking to the mess hall and back. She said "you have to walk" and didn't even look at my legs! Dr. I'm really afraid if I don't get some attention soon I may lose my leg. Inmate Logan Ward told me that you are familiar with this type of illness. Would you please call me to see you as soon as possible. I am really scared. My right foot is red and cold and numb most of the time. I have a lot of pain. Thank you. (Pet. #3, p. 169) An inmate request of similar urgency was sent by J.D. to the assistant superintendent the same day. Dr. Chapman responded by setting an appointment for J.D. to see her on March 29. On March 8, J.D. came to clinic reporting a medical emergency. The nurse noted left toes were purplish and cool; the right ankle and foot were cold and dark red and "unable to appreciate peripheral pulses". J.D. complained of pain behind his left knee and severe pain on slight touch to the right leg. He was referred to Dr. DeCespedes, who admitted him to the infirmary for observation. On examination, Dr. DeCespedes noted pulses and no edema. Dr. Chapman examined J.D. in the infirmary on March 13. She could not detect pulses in his lower extremities. She continued current medications and added Trental, a medication to increase blood flow. She ordered a Doppler pulse check and noted that the inmate should sign a medical release for records so that his prior hospital records could be obtained. Dr. Chapman also noted that the inmate should sign a consent sheet for peripheral vascular testing. On March 14, J.D. requested discharge from the infirmary, stating he felt better. He had complained early that morning that he could not sleep in the infirmary. Pulses were present but his lower extremities were cold. Dr. Chapman examined J.D. on March 29 and noted his severe peripheral vascular disease with leg pain. J.D. complained that he had been unable to get to the dining hall and guards were bringing him bagged lunches at times or a wheelchair. Dr. Chapman ordered a quad cane and crutches until the quad cane could be provided. She noted that he should have extra time to get to meals, but should not be given a wheelchair or bagged meals. She noted that she completed a consultation request for peripheral vascular testing by a vascular surgery consultant. For some reason unknown by Dr. Chapman and undisclosed by the record of this proceeding, J.D. was sent to a cardiologist, not a vascular surgeon. He was seen by Robert B. Garrett, M.D. on April 3. That same date, Dr. DeCespedes noted in J.D.'s clinical record that the cardiologist reported severe ischemia in the patient's legs, that J.D. needed special tests and he should be in a wheelchair, but twice daily he should walk 50 to 100 feet to exercise his legs. On April 10, J.D. sent an inmate request to the superintendent complaining about his medical treatment, stating he had pain and trouble walking, that he was given a wheelchair but that it was taken away, even though the specialist had recommended it. Dr. Chapman's response states that J.D. had a quad cane and was to be encouraged to be active. Further, the response states that J.D. had an appointment with her after his next specialist appointment. On April 11, 1991, Dr. Chapman reviewed Dr. Garrett's report and immediately requested a vascular surgery consultation. At some point, J.D. was transferred to administrative confinement, as requested by Dr. Chapman, so that he could have his meals delivered. J.D.'s vascular surgery consultation was scheduled for April 22, but was cancelled by security personnel and was rescheduled for May 9. CCI staff physician, Evidio Tornin, examined J.D. on April 30. He noted "no acute distress", but found a ischemic ulcer, nickel-sized, on J.D.'s right lower leg. He found severe circulatory insufficiency and was unable to detect pulses in J.D.'s extremities. The physician's notes acknowledge that J.D. had a vascular specialist appointment scheduled. Dr. Sweeney, the vascular surgeon, saw J.D. on May 9, 1991. His notes of the examination reveal he found a large ulceration on the right leg and a smaller ulceration on the left Achilles' tendon. Dr. Sweeney's impression was that the bypass grafts had occluded. Dr. Chapman's notes dated May 13 acknowledge the consultation with Dr. Sweeney, including Dr. Sweeney's concern that both legs would likely be lost if surgery were not done within the next two weeks. Dr. Chapman also noted that same date she had informed the regional utilization review nurse of the seriousness of the situation and the nurse agreed to an emergency admission to Southwest Florida Regional Medical Center under Dr. Sweeney's care. An arteriogram was scheduled for May 21, 1991, but was postponed for a day because of hospital equipment problems. After the test was done, Dr. Sweeney concluded that J.D.'s prior grafts were completely blocked and collateral vessels were supplying the only blood to his legs. Dr. Sweeney performed surgery to remove the infected grafts on May 28, 1991. After surgery, J.D.'s status deteriorated; his legs became non-viable and his temperature elevated to 103. On June 7, 1991, J.D. was taken to the operating room where Dr. Sweeney performed bilateral above the knee amputations. The Standard of Care CCI was a new prison when Dr. Chapman was hired to become its chief health officer. Originally built to house 700 inmates, it double-bunked to a maximum capacity of 1488 inmates by August 1989, and approximately 1400 inmates were housed there while Dr. Chapman was chief health officer. CCI was a close custody, medical grade IV institution. That is, it contained the most violent criminals with a full range of medical problems. Medical grade IV includes the sickest population in the correctional system, as well as all of the less serious medical grades. Dr. Chapman provided overall supervision to approximately 45 employees and direct supervision to approximately 10 employees. She held weekly and monthly staff meetings and was expected to review five sick call charts each day, Monday through Friday. There is ample evidence that Dr. Chapman periodically reviewed the files of both inmates at issue here. She was directly involved in their treatment and examined them personally on occasion. She was also responsible for their care as the supervisor of Dr. DeCespedes and the other staff physicians. Dr. Chapman's job was difficult, if not impossible, as conceded by the agency's expert witness. However, she violated the appropriate standard of care as to inmates A.J. and J. D. by failing to adequately supervise the treating physicians and by failing to obtain appropriate and timely consultations. The ultimate tragic outcomes of the two inmates' cases are plainly not the basis for this conclusion. Cryptococcal meningitis is a difficult disease to diagnose. And, there is a possibility J.D. would ultimately have lost his legs as a result of his persistent smoking, according to the warning of the cardiologist. Yet, in both cases there were increasingly urgent complaints by the subject inmates. Those complaints were deferred by punctilious observance of hollow routine, at best , and misplaced scepticism, at worst. In A.J.'s case, the treatment for sinusitis was appropriate, but the continued complaints of headaches and progressive loss of vision should have alerted the staff to a more pernicious cause. In J.D.'s case, although Dr. Chapman contends that his prior medical records were not obtained until several months after the amputations, the medical staff was well aware of his recent surgery and his history at the time he was received at CCI. The clues, in subjective complaints and in such objective physical signs as weak or non- existent pulse and ischemic ulcers, should have prompted a more immediate evaluation of his peripheral vascular status. In making the above findings of violations, substantial weight has been accorded the opinion of the agency witness, C. A. Rosenberg, M.D., who was appointed by the Federal District Court in 1983 after his nomination by the Department of Corrections, to serve on a three-physician survey team to monitor settlement of a case involving medical care in the Florida correctional system. Dr. Rosenberg's testimony was clear, competent and credible. He was not biased against the system, and was experienced in the role of a supervising physician. His analysis of the records he reviewed was incisive; that is, he distinguished convincingly between medical care that was appropriate and what was not. He acknowledged the difficulty of providing medical care under the circumstances experienced by Dr. Chapman and he confined his criticism to discrete, specific areas where action could have been taken, but was not. In that sense, although he articulated a standard of care that is the same standard imposed on a physician outside of an institutional setting, it is plain that he considered the conditions and circumstances under which Dr. Chapman labored in framing his opinion. Just as it is appropriate to consider these conditions and circumstances in determining whether a violation occurred, it is also appropriate to consider them in recommending an appropriate penalty. From her own testimony and those who have worked with her, Dr. Chapman is a caring physician and is well-respected. No evidence of other past discipline or cause for discipline appears in the record of Dr. Chapman's public service presented in this proceeding.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED: That the Board of Medicine enter its final order finding that Respondent violated section 458.331(1)(t), F.S. and establishing a penalty of two years probation and $2000 fine. DONE AND RECOMMENDED this 3rd day of March, 1995, in Tallahassee, Leon County, Florida. MARY CLARK 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 3rd day of March, 1995. APPENDIX The following constitute specific rulings on the findings of fact proposed by the parties as required by section 120.59(2), F.S. Petitioner's Proposed Findings Adopted or adopted in substance: Paragraphs #1-5, 7-8, 10-19, 21-25, 29- 35, 38-39, 42-52, 54-59, 61-67, 69-76, 81-84. Rejected as unnecessary: Paragraphs #9, 20, 26-28, 36-37, 40-41, 53, 78- 80. Rejected as unsupported by the weight of evidence: Paragraphs #60, 68, 77. Rejected as a conclusion of law, rather than finding of fact. (Moreover, the standard applied here is described in section 458.331(1)(t), F.S.): Paragraph #6 Respondent's Proposed Findings Adopted or adopted in substance: Paragraphs #1-3, 10-15, 17-21, 23-36 (with exception of final sentence), 37-48, 50. Rejected as unnecessary: Paragraphs #4-9, 16, 49. Rejected as unsupported by the weight of evidence: Paragraphs #22 (as to nursing notes being inconsistent with the blindness complaint), 27, 36 (final sentence-At least some evidence indicates he could not sleep in the infirmary and that is why he wanted to leave), 51-53. COPIES FURNISHED: Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Tom Wallace, Assistance Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Brett Thomas, Esquire Agency for Health Care Administration Legal Section 1940 North Monroe Street Tallahassee, Florida 32399-0792 Anthony D. Demma, Esquire Meyer and Brooks, P.A. Post Office Box 1547 Tallahassee, Florida 32302
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations that Respondent violated the provisions of Subsections 458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient R.E., as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0057927. Respondent practices primary care and internal medicine. He is board-certified in internal medicine, and has never had disciplinary action taken against his license. Patient R.E., a male who was 78 years old in January 2001, had a history of diabetes, hypertension, heavy smoking, high blood pressure, and circulatory problems. Respondent had first treated Patient R.E. on August 28, 2000, while covering for the physician with whom Respondent shared a practice. Patient R.E. had been a patient of the practice for several years. In August or September 2000, Respondent purchased the other physician's portion of the practice. The other physician remained as an employee of the practice until January 2001, when Respondent assumed the total care of Patient R.E. On January 16, 2001, Patient R.E. presented to Respondent with a complaint of redness and swelling in the right ankle that made walking difficult. Patient R.E. did not have a regularly scheduled office visit, but Respondent "squeezed him in" after Patient R.E. telephoned Respondent's office complaining of a great deal of pain. On January 16, 2001, the complete patient chart from the previous physician was available to Respondent and became part of Respondent's office chart for Patient R.E. Patient R.E.'s chart contained a "problem list" reflecting diagnoses made throughout his treatment at that office. A problem list assists the physician in tracking on- going problems with a patient. Patient R.E.'s problem list included a diagnosis of "PVD," or peripheral vascular disease. Peripheral vascular disease describes reduced blood flow to the extremities. It can be caused by a narrowing of large blood vessels, and exacerbated by diabetes-related small vessel disease. Prior to Respondent's involvement with his treatment, Patient R.E. had been evaluated for peripheral vascular disease, and was referred to a vascular specialist who recommended revascularization by way of bypass surgery. However, Patient R.E. declined the referral and elected to undergo chelation therapy instead. Mainstream physicians do not consider chelation an effective therapy for peripheral vascular disease, though Patient R.E. believed that it relieved his symptoms. After the November 11, 1999, physical exam, Patient R.E. was seen by the previous physician for three-month follow- ups on February 24, 2000, and June 5, 2000, with no particular complaints. As noted above, Respondent first saw Patient R.E. on August 28, 2000. This visit was for shortness of breath, diagnosed as bronchitis and treated with antibiotics and inhalants. Patient R.E. returned to see the previous physician on September 11, 2000, with chest congestion and coughing. This was his last office visit prior to January 16, 2001. The office visit of January 16, 2001, was a complaint- driven visit, meaning that Respondent's exam addressed Patient R.E.'s specific complaint. Such an exam is appropriate where the physician has a chart with a record of a complete history and physical exam. Respondent checked Patient R.E.'s blood pressure and listened to his heart and lungs, which were clear. Respondent then examined Patient R.E.'s right ankle, finding erythema (redness) and tenderness to palpation. Respondent did not perform an examination to address peripheral vascular disease, because he did not consider peripheral vascular disease as the presenting problem and was already aware that peripheral vascular disease was present in this patient. Respondent recorded a diagnosis of "? gout vs. cellulitis." Gout is an inflammation of the joints caused by deposition of uric acid crystals in the joint fluid. Cellulitis is a term given to an infection of the tissue, typically skin and underlying soft tissue. Gout and cellulitis are symptomatically similar conditions, in that both typically present with pain, stiffness, swelling, and redness of the affected area. Respondent prescribed Levaquin, an antibiotic, and Indocin, a medication for gout with some pain-relieving properties. Respondent told Patient R.E. to follow up in ten days, and gave Patient R.E. a quantity of medication for ten days' duration. Respondent's office chart did not clearly indicate instructions for the frequency or duration of the Levaquin prescription. The chart indicated that the Indocin was to be taken three times per day, but did not indicate a duration for taking the medication. On January 17, 2001, Patient R.E. telephoned Respondent's office to request a walker. On January 18, 2001, Respondent ordered a walker through a home health care provider and had it delivered to the patient's home. Respondent heard nothing from Patient R.E. on January 19, 2001. On Saturday, January 20, 2001, Respondent's office was closed. That evening, he received a telephone call from Patient R.E.'s wife, who told him that her husband was in a lot of pain. Respondent told the wife that Patient R.E. had not been on the prescribed medications long enough to cure his condition, and that if his pain became worse she should take him to the hospital emergency room. Shortly after 8:00 p.m., on January 20, 2001, Patient R.E. presented at the emergency room of Oak Hill Hospital complaining of pain and tenderness in his right ankle. There was an intact red blister over the ankle. The emergency room physician performed an examination, ordered blood tests, and confirmed the diagnosis of cellulitis. Patient R.E. was given injections of insulin and of Rocephin, an antibiotic. The emergency room physician instructed Patient R.E. to continue taking the Levaquin, and to stop taking the Indocin for the suspected gout. Respondent consulted with the emergency room physician by telephone. At Respondent's suggestion, the emergency room physician also prescribed Flagyl, another antibiotic, to ensure coverage against all potential anaerobes or aerobes that could cause cellulitis. The emergency room physician told Patient R.E. to follow up with Respondent on Monday, January 22, 2001. The emergency department of Oak Hill Hospital provided Patient R.E. with written discharge instructions for his cellulitis, including the following information: With antibiotic treatment, the size of the red area will gradually shrink in size until the skin returns to normal. This will take 7-10 days. The red area should never increase in size once the antibiotic medicine has been started. FOLLOW UP with your doctor or this facility as directed. If you were not given a specific follow-up appointment, look at the infected area in two days for the warning signs listed below. RETURN PROMPTLY or contact your doctor if any of the following occur: Increasing area of redness Increasing swelling, or pain Appearance of pus or drainage Fever over 100.5 orally Patient R.E.'s wife telephoned Respondent's office on Tuesday, January 23, 2001, to schedule a follow-up visit. The office visit was scheduled for January 26, 2001. On the scheduled date, Respondent examined Patient R.E. and found that his ankle had worsened and begun to develop necrosis. Respondent referred Patient R.E. to Dr. Malik Piduru, a vascular surgeon, for debridement, instructed him to continue taking the prescribed antibiotics, and to soak his foot in soapy water, which would help to debride the necrotic tissue in the interim. On February 1, 2001, Dr. Piduru examined Patient R.E. and noted a blue-black discoloration on the right lateral aspect of the lower right leg. The physical examination notes stated: "On the right lateral aspect of the leg approximately 6 x 4 cm necrotic, gangrenous patch of skin which appeared to be very fluctuant indicating underlying either abscess or hematoma of necrosis. The foot itself does not appear to be acutely ischemic and appears to be pink and viable." Dr. Piduru recommended hospitalization, excision of the necrotic area, and evaluation for further peripheral vascular disease correction. He also discussed the option of amputation if the leg did not heal. The surgeon noted that Patient R.E. understood the options presented to him, and the risks involved, but that Patient R.E. preferred to pursue another course of chelation therapy rather than undergo the recommended bypass surgery to correct the PVD. On February 5, 2001, Patient R.E. was admitted to the hospital for debridement of the right ankle. While in the hospital, Patient R.E. underwent an angiogram that revealed multiple occlusions of the blood vessels of the right leg. Dr. Piduru recommended bypass surgery, though he estimated the chances of success at around 30 percent. After discussion of all the options, Patient R.E. elected to have his right lower leg amputated. Dr. Piduru agreed that this was a reasonable decision in light of all the known factors. Patient R.E.'s right leg was amputated below the knee on February 12, 2001. In March 2001, Patient R.E. suffered an infection of the stump requiring additional hospitalization for debridement. His health continued to decline due to his multiple medical problems, including pain and peripheral vascular disease. On April 14, 2001, Patient R.E. was again admitted to Oak Hill Hospital with cellulitis of the left foot and the right stump. He declined any invasive procedures to restore circulation to his left leg. Patient R.E. was discharged to a hospice on April 20 and died on April 23, 2001. Dr. Patrick Hennessey, Petitioner's expert, testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient R.E. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient R.E., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes. Dr. Hennessey also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient R.E. Dr. Hennessey's opinion as to the standard of care was based on several criticisms of the examination conducted on January 16, 2001. First, Dr. Hennessey opined that Respondent should have scheduled a follow-up appointment within three days to evaluate Patient R.E.'s clinical response to the prescribed medicines. The quick follow-up was indicated because of Patient R.E.'s advanced age, and because Patient R.E.'s diabetes and peripheral vascular disease could cause the cellulitis to progress rapidly. Dr. Hennessey also noted that peripheral vascular disease can reduce the effectiveness of antibiotics, further indication of the need for a prompt follow-up examination. Dr. Hennessey also believed that a three-day follow-up was necessary to definitively rule out the differential diagnosis of gout, if Respondent seriously believed gout was a possibility. Dr. Hennessey testified that Indocin should have provided relief from gout within three days, and that Levaquin should have stopped any increase in swelling, pain, or size of the affected area if Patient R.E. was suffering from cellulitis. In Dr. Hennessey's opinion, a three-day follow-up appointment would have allowed Respondent to determine whether Patient R.E. was obtaining relief and, if not, to try a different antibiotic regime or pursue other avenues of treatment. Dr. Hennessey also believed that Respondent should have tested Patient R.E.'s blood sugar level on January 16, 2001. Dr. Hennessey testified that diabetes has an impact on a person's ability to fight infection, and that the right antibiotic would be inadequate if the patient had uncontrolled diabetes. Thus, Respondent should have assessed Patient R.E.'s current and recent diabetic controls. Finally, Dr. Hennessey criticized Respondent for failing to give Patient R.E. adequate instructions for monitoring his own progress after the January 16, 2001, appointment. Dr. Hennessey testified that the instructions that the Oak Hill Hospital emergency room provided to Patient R.E. on January 20, 2001, set forth in full above, were precisely the kind of instructions Respondent should have given to Patient R.E. on January 16, 2001. Dr. Hennessey could not say whether the amputation of Patient R.E.'s right leg was inevitable, though he conceded it was likely to occur within a year or two even if his preferred course of treatment had been followed. He concluded that, on January 16, 2001, the correct alternative was to undertake an "aggressive evaluation" and to make the case to Patient R.E. that he should undergo surgical re-vascularization immediately, while the skin was still intact. Dr. Hennessey's "best guess" was that this course could have given Patient R.E. "probably fifty percent or better likelihood" of avoiding amputation, though he also conceded that "there's a lot of unknowns in there." Dr. Hennessey concluded that the time lost between January 16 and February 1, when Patient R.E. was seen by Dr. Piduru, the vascular surgeon, made a successful outcome much less likely. Respondent's expert, Dr. Kent Corral, testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient R.E. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent did not deviate from the accepted standard of care in his treatment and care of Patient R.E. Dr. Corral also testified that in his opinion, Respondent did not violate Subsection 458.331(1)(m), Florida Statutes, by failing to compile appropriate medical records reflecting the treatment and care provided to Patient R.E. Dr. Corral testified that Respondent's examination of Patient R.E. was within the standard of care. The examination was complaint-driven, directed at the immediate presenting problem, a common and acceptable method employed by nearly all physicians in office practice. Dr. Corral testified that gout versus cellulitis is a very common differential diagnosis, especially in a patient with diabetes. Because there was inflammation of the ankle, peripheral vascular disease would fall very low on the list of possible diagnoses. Had Patient R.E. presented with a cold, necrotic foot, then peripheral vascular disease would have been more likely to be the presenting problem. Respondent knew that Patient R.E. had peripheral vascular disease, and it was apparent from the presenting symptoms that peripheral vascular disease was not the acute problem on January 16, 2001. Dr. Corral agreed that setting a three-day follow-up appointment would have met the standard of care. However, Dr. Corral disagreed that it was necessary to do so. He believed that Respondent reasonably elected not to schedule a three-day follow-up, but to follow up in ten days. Based on the information available on January 16, 2001, it was not unreasonable for Respondent to test the ten-day course of the prescribed antibiotics before scheduling a follow-up appointment. Dr. Corral testified that no laboratory tests were necessary to arrive at the differential diagnosis of gout versus cellulitis. He agreed that there was "potentially" some benefit to be derived from testing Patient R.E.'s blood sugar, but did not agree that Respondent's failure to do so amounted to practice below the standard of care. When Patient R.E.'s blood sugar level was checked in the emergency room on January 20, 2001, it was only slightly elevated. Dr. Corral also disagreed that Respondent failed to meet the standard of care in not giving Patient R.E. instructions on monitoring his own progress. Dr. Corral concluded that instructions would have made no difference. In his opinion, the antibiotic therapy was the only essential treatment to pursue on January 16, 2001. Dr. Corral believed that anything beyond the antibiotics would amount to "a hope and a prayer." In summary, Dr. Corral found the examination adequate and the diagnosis correct. He believed that the criticism of Respondent was due entirely to the poor outcome for Patient R.E., and that the poor outcome was not caused by anything Respondent did or did not do on January 16, 2001. In his own defense, Respondent testified that, prior to the January 16, 2001, appointment, he knew he was dealing with a very difficult patient who had a history of declining surgical intervention to resolve his circulatory problems. Respondent testified that his "first and foremost belief" was that Patient R.E. had cellulitis, and that the only other option, given the presenting symptoms, was an acute attack of gout. The potential for gout led him to prescribe Indocin as well as the antibiotics, because the Indocin would control the pain. Respondent noted that the emergency room physician confirmed his diagnosis of cellulitis on January 20, 2001. Respondent did not chart peripheral vascular disease on January 16, 2001, because that was not the presenting problem. Further, Respondent testified that Patient R.E.'s cellulitis was not necessarily related to peripheral vascular disease. Patient R.E. had several other problems, such as his heavy smoking and his diabetes, that could have generated cellulitis independently of peripheral vascular disease. Respondent disagreed with Dr. Hennessey's suggestion that "aggressive evaluation" and immediate surgery might have saved Patient R.E.'s foot, because it would not be prudent to undertake surgery until the cellulitis infection was cleaned up. Immediate surgery would have the potential of infecting the bypass grafts. On January 16, 2001, Patient R.E.'s foot was not gangrenous, and Respondent believed it essential to give Patient R.E. a reasonable trial of antibiotic therapy before sending him for surgical evaluation. Respondent's opinion on this issue was supported by Dr. Malik Piduru, the vascular surgeon who performed the amputation on Patient R.E.'s right leg. Dr. Piduru testified that in a patient with peripheral vascular disease and a diagnosis of cellulitis with no acute gangrenous changes or acute pain, the standard of care is to treat the infection first, then perform the re-vascularization. The weight of the evidence does not support an ultimate finding that Respondent failed to practice medicine with an acceptable level of care in the treatment of Patient R.E. Dr. Hennessey's conclusion that a more "aggressive evaluation" might have improved the chances of saving Patient R.E.'s leg rests on the assumption that Patient R.E. would have agreed to the proposed surgery had it been recommended on January 16, 2001. Patient R.E. rejected bypass surgery on his left leg before he became Respondent's patient, rejected it again in February 2001, and rejected it a third time in April 2001 when his right leg was threatened by cellulitis. There is little reason to assume that his decision would have been different on January 16, 2001. In view of all the evidence, the expert testimony of Dr. Corral was at least as persuasive as that of Dr. Hennessey in regard to the standard of care and Respondent's actions in this matter. Dr. Hennessey believed that the standard of care required a more aggressive approach to Patient R.E.'s presentation from the outset. Dr. Corral agreed that Dr. Hennessey's approach to the case would have met the standard of care, but also concluded that Respondent's approach was unexceptionable. Further, Dr. Hennessey could state with no degree of confidence that his own approach would have changed the ultimate outcome for Patient R.E. Dr. Hennessey opined that Respondent should have taken a blood sugar level and have given Patient R.E. detailed instructions for self-monitoring similar to those he later received at Oak Hill Hospital. Dr. Corral agreed that a blood sugar level might have been helpful, but was not necessary to meet the standard of care given the presentation and differential diagnosis. Dr. Corral believed that the failure to provide instructions was de minimus at most. Given the facts presented, Dr. Corral's opinion on these issues was at least as persuasive as Dr. Hennessey's. The evidence did not support a finding that Respondent took lightly Patient R.E.'s condition, or failed to consider any of the many variables created by Patient R.E.'s complicated history in arriving at a therapeutic approach. Respondent correctly diagnosed Patient R.E.'s cellulitis, and reasonably decided to attempt a course of antibiotic treatment to heal the infection before pursuing surgical options. The evidence presented at the hearing failed to establish that Patient R.E.'s poor outcome could be fairly attributed to Respondent's treatment of Patient R.E. on January 16, 2001. The main evidence submitted in support of the contention that Respondent failed to keep adequate medical records was directly related to the standard of care claim. Dr. Hennessey conceded that Respondent's medical record was minimally sufficient to justify the treatment provided. His chief criticism of Respondent's records for the January 16, 2001, appointment focused on the lack of documentation to explain actions that Respondent did not take, i.e., set a three- day follow-up appointment, order laboratory tests, and provide detailed instructions to Patient R.E. Because it has been found that the standard of care did not require Respondent to take these actions, his medical records cannot be faulted for failure to explain why he did not take them. However, Dr. Hennessey rightly criticized the lack of examination detail noted in the records of the January 16, 2001, examination. It was established at the hearing that Respondent charted by exception, meaning that he noted only positive findings rather than every unremarkable detail of the examination. Dr. Hennessey noted that, while this method of charting is acceptable practice, it was not acceptable that Respondent provided no description of the size or location of the erythema or the extent of the swelling of the ankle. Such detail would be essential to a subsequent treating physician in determining whether Patient R.E.'s condition had worsened. Further, Respondent did not note the frequency or duration of the Levaquin prescription, or the duration of the Indocin prescription, though Respondent credibly testified that he gave Patient R.E. oral instructions as to both medications. Again, a subsequent treating physician would need to know the details of Patient R.E.'s current medications before undertaking treatment. Finally, Respondent's notes were in several places illegible. Petitioner did establish that Respondent's records failed to document the office notes in a completely legible manner. The detail in Respondent's records was sufficient to justify the course of treatment on January 16, 2001, but their illegibility and lack of detail made them of limited use to anyone other than Respondent in assessing Patient R.E. for subsequent treatment. Patient R.E. was not exposed to potential injury because Respondent was consistently available to consult with the other treating physicians, but this fact does not cure Respondent's failure to keep adequate, legible records.
Recommendation Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated Subsections 458.331(1)(t), Florida Statutes, in his treatment of Patient R.E., and that the evidence is clear and convincing that Respondent has violated Section 458.331(1)(m), Florida Statutes, in his failure to keep appropriate written medical records regarding his treatment of Patient R.E. and that Respondent be reprimanded for that violation. DONE AND ENTERED this 17th day of July, 2003, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON 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 17th day of July, 2003. COPIES FURNISHED: Bruce A. Campbell, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Christopher J. Schulte, Esquire Burton, Schulte, Weekley, Hoeler & Beytin, P.A. 100 South Ashley Drive, Suite 600 Tampa, Florida 33602 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R.S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Disciplinary action should be taken against Respondent's license to practice medicine, number ME 0028355, issued by the State of Florida, based on the alleged violations of Section 458.331(1), Florida Statutes, as contained in the Administrative Complaint filed by the Petitioner.
Findings Of Fact At all times material to this complaint, Respondent was a licensed physician having been issued license number ME 0028355 by the State of Florida. This case represents Respondent's second disciplinary action. By a Final Order dated February 24, 1987, the Board of Medicine, in the case of Department of Professional Regulation vs. Robert Gonzalez, Jr., M.D., DOAH Case No. 85-1692, DPR Case No. 0033796, reprimanded Respondent, suspended Respondent's license for a minimum period of one year, and ordered a five year probationary period, and a $14,000 fine. The Final Order took effect upon filing and pertains to similar offenses at issue in the present case. (Adopts Petitioner's Proposed Finding of Fact (PFOF) 1) The present case arose from a review of hospital records and Respondent's patient records for seventeen patients who were hospitalized by Respondent at Pembroke Pines General Hospitals in Pembroke Pines, Florida in 1982 and 1983. However, none of the incidents giving rise to the complaint in the instant case occurred subsequent to the Final Order referenced in Finding of Fact 1 and all occurred during or shortly after the same timeframe as covered in the earlier offenses. (Adopts and expands Petitioner's PFOF 2). On August 4, 1982, Respondent admitted patient C.M. to Pembroke Pines General Hospital, who was assigned medical records number 6893 by Pembroke Pines General Hospital. The admitting diagnosis was acute respiratory tract infection, acute flu syndrome, acute laryngo/pharyngitis and possible pneumonitis. The patient was hospitalized for a period of two days. During the hospitalization of patient C.M., Respondent ordered the following tests which were performed on patient C.M.: two chest x-rays, "mono" screen, throat culture, blood serum levels (special 12), electrolytes, urinalysis, complete blood count (C.R.C.) and Platelet counts. Respondent discharged C.M. from Pembroke Pines General Hospital with the following diagnoses on August 7; 1982: acute flu syndrome, acute respiratory tract infection, and acute pharyngitis due to staphylococcus aureus. (Adopts Petitioner's PFOF 3) Pharyngitis is an inflammatory reaction of the throat. Although Respondent diagnosed patient C.M. as suffering from acute pharyngitis due to staphylococcus aureus, there was inadequate laboratory data to justify this diagnosis. The diagnosis should have been predicated upon the results of a sputum (secretions coughed out of the lungs) culture and sensitivity test. However, the results of the culture and sensitivity test were negative for the throat. Therefore, this diagnosis was incorrect. (Adopts Petitioner's PFOF 4). Pneumonitis is an infection of the lungs. The standards of the medical profession require that it be based on positive x-ray findings. In the case of patient C.M., there was no justification for Respondent's diagnosis of pneumonitis because both of the chest x-rays taken pursuant to Respondent's order were normal. (Adopts Petitioner's PFOF 5) Although Respondent diagnosed patient C.M. as suffering from acute flu syndrome, there was no justification for this diagnosis either. In fact, there was no justification for the admission of the patient to Pembroke Pines General Hospital. It is contra-indicated to hospitalize a sixteen-year-old male suffering from an upper respiratory infection because of the danger of developing a nasocomal infection, which is an infection that is produced as a result of exposure to bacteria in the hospital. By hospitalizing C.M. unnecessarily, Respondent placed patient C.M. at undue risk. (Adopts Petitioner's PFOF 6) In the year 1983, Respondent admitted patient F.L. to Pembroke Pines General Hospital on three occasions. The patient was assigned medical records number 4141 by Pembroke Pines General Hospital. The admission date for the hospitalizations were February 20, 1983, July 8; 1983, and August 31, 1983. There were no problems with the July 8, 1983, hospitalization of patient F.L. (With the elimination of subordinate and unnecessary material, this FOF adopts Petitioner's PFOF 7). On February 20, 1983, Respondent admitted patient F.L. to Pembroke Pines General Hospital with an admission diagnosis of cephalgia and uncontrolled hypertension. The patient was hospitalized for a period of three days. During this three-day period, the following tests were performed on patient F.L., pursuant to Respondent's orders: an intraveneous pyelogram (IVP) and voiding cystogram, chest x-ray, three "E.K.G.s", an SMA-18 (blood serum levels for eighteen different substances), a CRC, an echocardiogram, a 24-hour urinalysis for total protein, serum electrophoresis, a twenty-four hour urinalysis for catecholamine and methanephrine, a CT scan of the brain, a sinus series x-ray and cervical spine x-ray, an upper GI series, small bowel study, a cardiac isoenzyme profile and a plasma renin study. (Adopts Petitioner's PFOF 8) A voiding cystogram is a test used to check on the condition of the prostate. There was no indication in the records of patient F.L. of any prostate problem or complaint. Hence, there was no justification for the voiding cystogram which Respondent ordered for patient F.L. The upper G.I. series with small bowel follow-through, would be indicated if there is suspected small bowel obstruction or small bowel involvement. In Respondent's records for patient F.L., and the records pertaining to the hospitalization of F.L. at Pembroke Pines General Hospitals there is no indication that patient F.L. complained of or suffered from gastro-intestinal complaints. Therefore, the upper G.I. series with small bowel follow-through Respondent ordered was not justified. Additionally, the patient was admitted with cephalgia (headaches), and sinus x-rays and cervical spine x-rays were ordered. Sinus x-rays and/or cervical spine x-rays would be indicated where there was a history or indication of involvement of the sinus or cervical spine. Respondent's records for patient F.L. do not document any indication of involvement of the cervical spine and provide no history of sinus trouble. Accordingly, the cervical spine and sinus x-rays ordered by Respondent were neither indicated nor justified for patient F.L. C.P.K. enzymes are enzymes released into the bloodstream with damage of certain tissues in the body. Respondent ordered a cardiac isoenzyme profile to determine whether there was evidence of elevated C.P.K. enzymes and, therefore evidence of acute myocardial damage in patient F.L. However, patient F.L. displayed no symptoms which would justify performing this test. (With minor modifications to clarify the - finding and to conform to the record, FOF 9-11 adopt Petitioner's PFOF 9) On February 23, 1983, Respondent discharged patient F.L. with the following diagnoses: Cephalgia due to the presence of uncontrolled hypertension-diastolic, hyperuricemia, essential hypertension, neck pain secondary to cervical degenerative arthritis and chronic sinusitus condition, left maxilla. There was no justification in the records for patient F.L. which would establish uncontrolled hypertension, as a diagnosis, although Respondent's office records for patient F.L. do document the presence of hypertension in this patient and that numerous therapies were utilized unsuccessfully to control that hypertension. (With minor modifications to clarify the finding and to conform to the record, FOF 12 adopts Petitioner's PFOF 10) On August 31, 193, Respondent admitted patient F.L. for what Respondent described as a "mass of the left hemi- thorax" and labile hypertension. The mass was, in fact, a keloid or excess scar tissue which measured 2 centimeters at its greatest dimension. The records for patient F.L. provided a history of two previous resections of the same keloid. It constituted excessive, expensive and unnecessary hospitalization for Respondent to admit patient F.L. for removal of such a keloid, when that keloid could have been removed in the Respondent's office under local anesthesia. Also as a result of Respondent's decision to unnecessarily hospitalize patient F.L. for removal of a keloid, unnecessary pre-operative testing also was performed. This testing included a chest x-ray, an SKG, a complete blood count, an SMA 18, a urinalysis, and prothrombin dime or clotting tests. Respondent knew when he hospitalized patient F.L. for the surgical procedure of removal of a keloid that these pre-operative tests would be routinely performed. This constitutes inappropriate treatment. Since the history clearly indicated that the keloid, if removed, almost certainly would have reoccurred unless a plastic surgeon provided follow-up treatment to prevent the reformation of the keloid, its excision was unjustified. Accordingly, there was no justification for the admission of patient F.L. to Pembroke Pines General Hospital in August 1983. (Accepts, with modifications to reflect the record as a whole, Petitioner's PFOF 11-12). On September 2, 1983, Respondent discharged patient F.L. with the following diagnoses: keloid anterior chest wall, labile hypertension and anxiety reaction. Labile hypertension is hypertension that fluctuates erratically. This diagnosis was not supported by the hospital record for F.L. All blood pressure readings for the record for F.L., were constantly normal. (Adopts Petitioner's PFOF 13) On April 5, 1983, Respondent admitted patient J.G. to Pembroke Pines General Hospital for acute low back syndrome and weakness of the right extremities. Patient J.G. was assigned medical records number 2693 by Pembroke Pines General Hospital. Respondent hospitalized patient J.G. for a period of three days. During this hospitalization of patient J.G., Respondent provided no significant therapy which would justify hospitalization. Respondent's treatment of Patient J.G. during hospitalization included orders for Robaxin, a muscle relaxant, Riopan Plus, an antacid, Paraon forte, a muscle relaxant, and Ducolax suppositories and Peri-colase capsules for constipation. Additionally, the patient was treated with traction for the three-day period. The patient was given pelvic traction of twenty pounds- with alternating periods of two hours with traction and two hours without traction. In order to be effective or beneficial, the traction should have been given over a much longer period of time. Finally, Respondent treated patient J.G. with K-pads or heat pads around the clock. (Adopts Petitioner's PFOF 14). On April 6; 1983, patient J.G. was seen by an orthopedic consultant, pursuant to Respondent's request. The consultant's impression of the patient's condition was of cervical spondylosis. The consultant's recommended plan of treatment included bed rest and oral anti-inflammatories. (Adopts Petitioner's PFOF 15). Respondent's entire work-up and evaluation of patient J.G.; including the orthopedic consultation, could have been performed as an outpatient. There was no justification for the admission of patient J.G. to Pembroke Pines General Hospital. (Adopts Petitioner's PFOF 16). On October 10, 1982, Respondent admitted patient E.R. to Pembroke Pines General Hospital for acute cephalgia and photophobia. Patient E.R. was assigned medical records number 4910 by Pembroke Pines General Hospital. On admission, Respondent recorded a long-standing history of the patient suffering from headaches and chronic migraine syndrome. There was no justification for Respondent to admit patient E.B. for headaches, or for evaluation of these headaches. Respondent's migraine headaches might reasonably have been addressed by an initial referral to a neurologist on an outpatient basis. This was not done. (With elimination of subordinate and unnecessary material and as modified to more closely conform to the record as a whole, this FOF covers Petitioner's PFOF 17.) During the hospitalization of E.R., Respondent ordered a number of tests including two electrocardiograms, a CT scan of the brain, chest x-ray; sinus x-ray; mastoids x-rays; x-rays of the sella turcica and cervical spines, a bilateral mammogram, a CT scan of pituitary gland, a tomogram of the sella turcica, a platelet count, serum protein electrophoresis, CEA-EIA Enzyme Immunoassay, an SMA 12, Vitamin B12 and Folate serum levels, and progesterone levels. (Adopts Petitioner's PFOF 18). The testing ordered by Respondent for E.R. was excessive. For example, Respondent ordered a CT scan of the brain which adequately views the sinuses and the sella turcica. Therefore the further x-rays of the sinuses, mastoids and sella turcica and a tomagram of the sella turcica, were unnecessary and excessive. No other indicators, i.e. vision disturbances, independently justified Respondent's ordering the tomagrams. A C.E.A.-E.I.A. Enzyme Immunoassay was ordered, despite the fact that it was not indicated by either the patient history or the recorded physical examination results. A C.E.A.- E.I.A. Enzyme Immunoassay is a test for cancer of the stomach. (With elimination of cumulative and subordinate material, adopts Petitioner's PFOF 19). On May 8, 1983, Respondent admitted patient E.P. to Pembroke Pines General Hospital for evaluation and treatment of a gastrointestinal disorder, weakness and shortness of breath. E.P. was assigned medical records number 4924. Respondent ordered the following testing which was performed on patient E.P.: two CBCs, SMA-18, two urinalyses, CT scan of kidneys, barium enema, a GI series and small bowel follow-through, an intraveneous pyelogram a voiding cytourethrogram a platelet count, serum protein electrophoresis, a urine culture and a stool culture. There was no indication for Respondent to order the upper G.I. series and small bowel follow-through for patient E.P. The records demonstrate insufficient justification for the admission of patient E.P. to Pembroke Pines General Hospital on May 8, 1983; the final discharge diagnoses show hospitalization was unnecessary. On May 12, 1983, Respondent discharged patient E.P. from Pembroke Pines General Hospital with the following diagnosis: gastrointestinal disorder due to diverticulosis of the colon gastritis, and anxiety state reaction. Of these diagnoses, only the final diagnosis is possibly correct. Although an air contrast barium enema showed a few tiny scattered diverticuli within the distribution of the left colon, there was no support for Respondent's assertion that the diverticuli were the cause of a gastrointestinal disorder. The diagnosis of gastritis refers to an irritation of the stomach. This diagnosis is not supported either by the results of the upper G.I. series which were normal nor by x-rays of the stomach, which were also normal. (With modifications to more accurately reflect the record as a whole, this FOF accepts Petitioner's PFOF 21-23). On April 20, 1983, Respondent admitted O.A. to Pembroke Pines General Hospital. O.A. was assigned medical records number 5800. Petitioner established no violations by Respondent with regard to this patient. (Covers Petitioner's PFOF 24). On September 20; 1982, Respondent admitted patient R.R. to Pembroke Pines General Hospital. Patient R.R. was assigned medical records number 5940. Petitioner established no violations by Respondent with regard to this patient. (Covers Petitioner's PFOF 25). On April 12, 1983, Respondent admitted to Pembroke Pines General Hospital a patient who was assigned medical records number 9235. The patient was admitted for acute abdominal pain on the right lower side. The patient was suffering from a hematoma, a collection of blood in the tissue. Most probably the patient had developed a hematoma of the rectus muscle as a result of coughing, because the patient's history revealed a severe upper respiratory infection accompanied by a cough. A surgical consultation prior to hospital admission would have revealed this condition and rendered hospital admission unnecessary; because the standards of the medical profession indicate that the hematoma should have been treated conservatively (i.e. no treatment was indicated). No testing should have been necessary, if a consultation had been sought. However, Respondent hospitalized the patient, ordered a chest x- ray, a pelvic sonogram and a barium enema. Neither the barium enema nor the pelvic sonogram would have been indicated if the patient had been seen by a consultant prior to ordering the tests. The patient was ultimately discharged on April 14, 1983 therefore, the hospitalization was unnecessary. (Adopts, with clarifying modification, Petitioner's PFOF 26-27). On March 29, 1983, Respondent admitted patient R.S. to Pembroke Pines General Hospital. Patient R.S. was assigned medical records number 9479 at Pembroke Pines General Hospital. No evidence was presented by Petitioner as to the propriety or necessity for the admission or the testing performed during the hospitalization of the discharge diagnoses. (With elimination of unnecessary material, this FOF adopts Petitioner's PFOF 28). On October 10, 1982, Respondent admitted patient K.G. to Pembroke Pines General Hospital. The patient was assigned medical records number 9540 by Pembroke Pines General Hospital. This twenty-three year old female was admitted with diagnoses of gastro-intestinal disorder and menstrual period disorder. The patient remained in the hospital for a period of three days. During the hospitalization, Respondent ordered the following tests: chest x-rays of sella turcica, a barium enema, pelvic sonogram; an EKG, an upper G.I. series with small bowel follow-through- a urinalysis, a platelet count, serum glucose levels (four); SMA 12, urine culture and colony count, progesterone levels, S Follicle- stimulating hormone levels and total estrogen levels. The x-rays of the sella turcica would be indicated where a pituitary tumor is suspected, but there was no indication that a pituitary disorder was suspected other than a vague reference to a menstrual disorder (which was never described in the records for patient K.G.). Therefore, this test was unnecessary. Although a barium enema was ordered, there was no description of pain or any disorder of the bowel and no indication of bowel changes which would indicate any disease of the colon. Therefore, the barium enema was not justified. Although the records reflect at least vague indications for ordering the upper GI series, the small bowel follow-through was not justified. Additionally, one isolated estrogen level was ordered. This was inappropriate because the test results would only be meaningful if a series of estrogen levels were obtained to determine the response curve of the ovaries. Therefore, "inappropriate" in this case means "unnecessary." The hospital admission of patient K.G. also was not appropriate. The entire evaluation could have been carried out by a gynecologist on an outpatient basis. No initial, pre-hospitalization referral to a gynecologist was reflected in Respondent's records. The patient was discharged on October 13, 1982, with the following diagnoses: abnormal menstrual periods due to left ovary cyst and abnormal pain due to mild gastritis associated with mild anxiety stage reaction. On his discharge summary for patient K.G., Respondent noted "all this information was given to the patient and was advised the patient to be seen by gynecologist for further result." Respondent's records further corroborated that the hospitalization was unjustified and unnecessary. (Covers Petitioner's PFOF 29-31) On August 4, 1982, Respondent admitted patient L.M. to Pembroke Pines General Hospital for treatment of "acute phlebitis". The patient was assigned medical records number 6965 by Pembroke Pines General Hospital. The patient was hospitalized for a period of thirteen days. Phlebitis is an inflammatory reaction of the vein(s). It is very important that the diagnosis be correct; because, with phlebitis, emboli or clots can break off and travel through the blood to the lungs. It is diagnosed clinically by history and by physical examination. On physical examination, the symptoms of phlebitis include the presence of swelling in the involved leg and the positive "Homan's sign." "Homan's sign" is the term used to describe the pain present from an inflamed deep vein, which pain is experienced when the leg is extended straight out and the foot is dorsiflexed or pushed back towards the leg placing stress on the calf muscle. Radiographically a venogram may be used to confirm or rule out the existence of phlebitis. A venogram is a test involving the injection of dye into the veins of the foot followed by an x-ray examination of those vessels. The records for patient L.M. do not contain adequate documentation of a physical examination of patient L.M. to establish the diagnosis of phlebitis. Thus, the patient may have had phlebitis, there were no adequate descriptions of the status of the right leg recorded in the patient records for L.M. Specifically, there is no mention of Homan's sign and there was no mention of any measurement of the patient's calves to determine whether there was swelling in the involved leg. Without a more thorough physical examination, Respondent should have performed a venogram to confirm the diagnosis. This was not done with patient L.M. (Adopts Petitioner's PFOF 32-34). While patient L.M. was hospitalized, Respondent treated the patient's unconfirmed phlebitis with Heparin (an anti-coagulent) intravenously. The patient remained on Heparin until August 15; 1982. On August 15, 1982, Respondent additionally ordered Coumadin, which is also an anti-coagulent, to be given to patient L.M. Respondent ordered Coumadin 5 mg. to be given by mouth at 6:00 p.m. (to be started on August 15, 1982)), and at 10:00 a.m. (to be started on August 16, 1982). Respondent's order provided that if the P.T. (prothrombin time) was twenty-five seconds, to hold the Coumadin. The normal prothrombin time is in the range of eleven to thirteen seconds. The dose of Coumadin given was inadequate to anti-coagulate the patient. (Adopts Petitioner's PFOF 35). On the day prior to discharge of L.M., Respondent wrote the following order: "If (patient) is below 20-tomorrow- and over 11.0. (patient) may be discharge(d)..." For the Coumadin to be effective (i.e. in order to have an adequate anti-coagulant effect from the Coumadin), the prothrombin time should have been above twenty prior to discharge. The prothrombin time on discharge was 12.9 seconds. (Adopts Petitioner's PFOF 36). From the hospital records for patient L.M. and the Doctor's orders for that patient there is adequate basis for the expert testimony that Respondent does not understand the therapeutic effect of Coumadin or its dosages. (Covers Petitioner's PFOF 37). On August 17, 1982; Respondent discharged patient L.M. from Pembroke Pines General Hospital with the following diagnoses: acute phlebitis of the right leg, anxiety stage reaction and migraine syndrome headaches. As discussed previously, the diagnosis of phlebitis cannot be substantiated from the records. Additionally, the records contain no documentation for the diagnosis of migraine syndrome headaches. (With the elimination of unnecessary material, this FOF adopts Petitioner's PFOF 38). On August 9, 1982, Respondent admitted patient M.A. to Pembroke Pines General Hospital for abdominal pain and a gastrointestinal disorder. This patient was assigned number 7448. The documentation of the history and physical examination for patient M.A. was significantly lacking. Patient M.A. was hospitalized for a period of three days. During that three-day period of hospitalization, the following tests were performed on M.A. pursuant to Respondent's orders: an E.K.G., a chest x-ray, an abdominal sonogram, a barium enema, a CRC, a urinalysis, a coagulation test and platelet count, fasting and non-fasting glucose levels (a total of six) SMA 12, a routine stool culture and a colonoscopy. All of the testing performed on patient M.A. could have been performed on an out-patient basis. There was no justification for admission of M.A. to Pembroke Pines General Hospital on August 9; 1982, or for the length of stay. Additionally, Respondent ordered the abdominal sonogram on patient M.A. without any indication for the test, which was unnecessary. This abdominal sonogram was used to view the liver, gallbladder and pancreas. However, there was no indication that M.A. experienced any problems with these organs. (Adopts Petitioner's PFOF 39-40). On admission, Respondent ordered that Diabenese 500 mg. (a glycogenic drug which will reduce the blood glucose levels and is normally used in the treatment of diabetes) be given by mouth daily. Additionally, Respondent ordered that the patient be given insulin on a sliding scale. Insulin is also normally used in the treatment of diabetes. However, diabetes was not listed as a diagnosis on discharge. The hospital chart provides no documentation for the use of Diabenese or the insulin. All glucose levels taken on this patient were within normal limits during the August 1982 hospitalization, and these eliminate any justification for the use of Diabenese or insulin for diabetes unrecorded. (As modified for clarity and to add the inference drawn by the undersigned from the evidence, this FOF adopts Petitioner's PFOF 41). On August 12; 1982, Respondent discharged patient M.A. from Pembroke Pines General Hospital with the following diagnoses: gastrointestinal disorder, abdominal pain secondary to several small diverticula of the left side of the colon, villous adenoma of the sigmoid colon, sinus bradycardia condition and essential hypertension. Several of Respondent's discharge diagnoses were either incorrect or not documented in the records for patient M.A. Sinus bradycardia is a very slow pulse rate. The pulses recorded for patient M.A. during hospitalization were 80, 68, 64, 68, 74 and 70 beats per minute, and were all within normal ranges. On one E.K.G. a notation was made that the pulse rate was slow. However, given the persistently normal pulse rates throughout the patient chart, the diagnosis of sinus bradycardia was incorrect. Additionally, Respondent's diagnosis of essential hypertension was incorrect. Essential hypertension means that type of hypertension for which there is no known cause. All of the blood pressure readings present in the hospital chart for M.A. were normal. Furthermore, the patient was taking no anti-hypertensive agents. Therefore, Respondent's diagnosis of essential hypertension in patient M.A. was also incorrect. Only one of Respondent's discharge diagnoses for patient M.A. was justified by use records for that patient, that of villous adenoma of sigmoid colon. This diagnosis was initially made by a consultant. (Adopts Petitioner's PFOF 42- 44). On March 22, 1983, Respondent admitted patient E.S. to Pembroke Pines General Hospital for abdominal pain with possible biliary disorders. The patient was assigned number 7917 and was hospitalized for a period of fourteen days. During that hospitalization, the following tests were performed on patient E.S., pursuant to Respondent's orders: an EKG, cervical spine x-rays; a voiding cystourethrogram and intravenous pyelogram, gallbladder sonogram; chest x-ray, an echocardiogram, a barium enema, an upper G.I. series, an oral cholestogram, small bowel series, sonogram of the thyroid glands an air contrast barium enema, a CRC, urinalysis, platelet count, glucose levels (a total of nine), SMA 12, a glucose tolerance test, an SMA 8, which included a serum glucose level, two routine stool cultures, a Thyroid profile, a two-hour post prandial blood sugar, 24 hour urine creatinine levels, insulin levels, by radioimmunoassay, and a Parathyroid hormone study. Much of the testing performed on E.S. during the hospitalization was excessive or unnecessary. Those tests that were indicated could have been performed on an out-patient basis. The insulin level by radioimmunoassay is indicated where secreting tumors of the pancreas are suspected. There was no indication in the records of patient E.S. that such a tumor was present. The intraveneous pyelogram is indicated where kidney disease is suspected. There was no indication in E.S.'s records that kidney disease was suspected or present. A sonogram of the thyroid is indicated where there is a palpable mass of the thyroid. In the records for patient E.S. there is no record of a palpable mass. In the records for patient E.S., the thyroid was described as mildly to moderately enlarged. However, there was no description of a mass or venous distention, and the carotid pulses are present. Therefore, it would appear unlikely that a mass was present. Accordingly, there was no indication for a sonogram of the thyroid gland. After performing a sonogram of the gall bladder (for which there was no indication) which yielded normal findings, Respondent ordered a cholecystogram. This latter test involves the oral consumption of a dye which is then excreted into the gallbladder so that the gallbladder can be viewed by x-ray. The test is used to determine if there are any filling defects in the gallbladder. In view of the normal gallbladder sonogram which had already been performed on patient E.S., it was excessive to additionally order the cholecystogram. There was no indication for performing a small bowel series on this patient. It was excessive to order and perform nine glucose levels where all of the levels obtained were within normal ranges. Respondent performed no real therapy on patient E.S. during the above-described hospitalization. The hospitalization was for diagnostic purposes. On April 5, 1983, Respondent discharged patient E.S. from Pembroke Pines General Hospital with the following diagnoses: diverticulosis of the sigmoid and descending colon, borderline diabetes mellitus, hyperuricemia, enlarged thyroid gland with hypofunctioning, diverticulum of the bladder and essential hypertension. The diagnosis "borderline diabetes mellitus," wads not justified by the patient's chart since all glucose levels found in the patient's chart were within normal ranges. (Adopts Petitioner's PFOF 45-47). On September 17, 1982, and on May 10, 1983, Respondent admitted patient A.W. to Pembroke Pines General Hospital. The patient was assigned medical records number 2966 by Pembroke Pines General Hospital. Petitioner established no violations with regard to this patient. (Covers Petitioner's PFOF 48). On October 6, 1982, Respondent admitted A.P. to Pembroke Pines General Hospital for a possible angina attack and a possible myocardial injury attack. Patient A.P. was assigned medical records number 8000 by Pembroke Pines General Hospital. Despite the fact that angina was suspected, Respondent failed to obtain a cardiac consultation during the October 1982 hospitalization of A.P. During the hospitalization of patient A.P., four chest x-rays and one CT Scan of the chest were performed pursuant to Respondent's orders. These tests revealed two areas of increased density in the left chest which were characterized as "masses." The recommendation made by the radiologists who reviewed the x-rays and the CT Scan was that further evaluation was necessary. Despite this recommendation, no further evaluation was performed in the hospital and no plan of follow-up or referral was included in the discharge summary prepared by Respondent. The importance of such documentation on "follow-up" is that it shows that the physician is aware of the problem and assures that the patient will be properly managed. From the records for A.P., it is impossible to determine whether or not Respondent planned proper management of the "masses" after discharge of the patient. (As modified to conform to the record as a whole- this FOF accepts Petitioner's PFOF 49-50). On October 23, 1982, Respondent discharged patient A.P. from Pembroke Pines General Hospital with several discharge diagnoses including the diagnosis of sliding hiatus[sic] hernia with gastroesophageal reflux. This diagnosis was not supported by the records for the patient. The hiatus is the opening in the diaphragm through which the esophagus passes into the stomach and should fit very snugly. In the case of a hiatal hernia, due to the increase of intra- abdominal pressure, a portion of the stomach slips through that opening and slides back and forth. Most commonly, if the patient is lying down, and particularly if the patient has had a sizable food intake immediately prior to lying down, the weight of the food will carry the stomach up into the abdomen. This is the disorder which Respondent diagnosed in patient A.P. The disorder is properly diagnosed by x-ray, specifically an upper G.I. series, Respondent did not order one. Respondent did order an upper abdominal sonogram and chest x- rays, neither of which would or did verify the existence of a sliding hiatal hernia with gastroesophageal reflux. Accordingly, Respondent's diagnosis was not substantiated. (As modified for clarity and to include the inferences of the undersigned, this FOF adopts Petitioner's PFOF -51). On July 1, 1983, Respondent admitted patient T.S. to Pembroke Pines General Hospital. Patient T.S. was assigned medical records number 9478 by Pembroke Pines General Hospital. The patient was admitted for acute right renal attack and remained in the hospital for a period of six days. On the patient's history, Respondent noted that his impression diagnosis was sinus bradycardia as a secondary problem. Respondent's evaluation of the cardiac status of the patient included ordering the following tests: three E.K.G.'s all of which were abnormal, indicating a previous myocardial infraction of indeterminate age, and a cardiac profile. In Respondent's Discharge for patient T.S., Respondent wrote: On admission, the patient was seen and examined by the ER physician, and after examination was accomplished the patient was admitted to the Telemetry Unit due to the previous history of organic heart disorder and having cardiac arrythmias. The patient was also complaining of chest pain at this time... Despite the above information, Respondent failed to obtain a cardiac "consult" for patient T.S. Furthermore, the cardiac status for the patient was never adequately evaluated. This does not meet the prevailing standards of the medical profession. (Adopts and expands Petitioner's PFOF 52-53). On July 2; 1983, an intraveneous pyelogram (IVP) was performed on patient T.S. pursuant to Respondent's order. The IVP revealed distal right ureteral calculus (or a kidney stone), which was the cause of the patient's renal (kidney) attack. Once the diagnosis of renal calculus was established, patient T.S. should have been discharged. Any remaining pain could be controlled with oral medication. However, instead of discharging the patient, Respondent kept the patient in the hospital for five extra days without adequate justification in the records. (Adopts and expands Petitioner's PFOF 54-55). While patient T.S. was hospitalized, Respondent ordered the following unnecessary or excessive testing: Lanoxin serum levels, quinidine serum levels, and a second IVP. The Lanoxin and quinidine levels would be indicated where it was necessary to monitor the levels of those drugs in the blood. However, the chart for patient T.S. contained no documentation that either quinidine or lanoxin were being administered to the patient, and, therefore, these tests were inappropriate. The second IVP was excessive testing because the first IVP provided all of the information sought by the second IVP, and the diagnosis was established on the original IVP. The hospitalization of patient T.S. was excessive in length and probably should have been no more that two days. (Adopts Petitioner's PFOF 56-57). On October 29, 1982, Respondent admitted patient D.S. to Pembroke Pines General Hospital for a hypertensive crisis and cardiomegaly. Petitioner established no violations with regardo this patient; who was assigned records number 0905. (Adopts Petitioner's PFOF 5). In general, the unrefuted expert testimony supports a finding that with respect to all of the records previously described, excluding patients O.A., R.R., R.S., A.W., and D.S., the admission notes and discharge summaries were not coherent. The undersigned accepts the expert testimony of Dr. Ehrlich that a large part of this lack of coherency is probably due to Respondent's inability to communicate in English with proficiency and fluency. However, the undersigned finds upon the expert opinion testimony of both Dr. Handworker and Dr. Ehrlich that these records of Respondent were additionally medically deficient as reflected in the foregoing findings of fact, in that Respondent's records failed to include pertinent necessary historical data that would be indicated, and Respondent failed, in his discharge summaries, specifically, to address the need for follow-up care. (Adopts, with modifications for clarity, Petitioner's PFOF 59). The refuted expert testimony is that with reference to two patients, M.A. and L.M., Respondent's records were not sufficient to justify the treatment of the patient. With respect to patient M.A., there was a significant lack of documented history and physical examination. With respect to patient L.M.; there was inadequate documentation of the clinical history and physical examination results, or of pertinent laboratory testing (venogram) to show that the patient, in fact, had phlebitis. Therefore, there was inadequate documentation for administering anti-coagulants to this patient. (Adopts Petitioner's PFOF 60). The unrefuted expert testimony is based only upon review of records. Neither testifying physician treated any patient referenced. In the case of at least one patient, the name is difficult even to determine. However, it is clear that in many instances; Respondent's records contained inadequate information to justify admission of the patients to the hospital, particularly with respect to patients C.M. (6893), F.L. (4144), J.G. (2693), E.R. (4910), E.P. (4924), 9235, K.G. (9540), M.A. (7448), and E.S. (7917). In many instances; Respondent's records were inadequate to justify many of the diagnoses which were made by Respondent. Specifically, the records for patient C.M. (6893), F.L. (4144), E.P. (4924), L.M. (6965); M.A. (7448), and E.S. (7917), did not contain justification for many of the diagnoses made by Respondent. In many instances, the records were not adequate to justify all of the testing performed, particularly those records for F.L. (4144), E.R. (4910), Patient No. 9235, K.G. (9540), M.A. (7448), E.S. (7917) and T.S. (9478). In two instances; with respect to patients M.A. (7448) and T.S. (9478); Respondent's records were inadequate to justify the length of the hospital stay. (Adopts Petitioner's PFOF 61). In many instances, Respondent unnecessarily admitted patients. By admitting patients unnecessarily and for excessive periods of time, Respondent benefited from the daily charge which he could assess for seeing the patient while hospitalized and it is possible to infer therefrom that this amounts to exploitation of patients C.M. (6893), F.L. (4144), J.G. (2693), E.R. (4910), E.P. (4024), Patient No. 9235, K.G. (9540), M.A. (7448), and E.S. (7917) for the financial gain of the Respondent. However, without some further evidence of malicious intent above and beyond mere incompetency, the undersigned views the evidence insufficient to draw such an inference. (For the reasons stated herein, Petitioner's PFOF 62 is rejected). Then Respondent unnecessarily or excessively tested patients [Specifically, patients F.L. (4144), E.R. (4910), E.P. (4924); Patient No. 9235, K.G. (9540), M.A. (7448), E.S. (7917) and T.S. (9478)], the patients or their insurance companies were required to pay the hospital for these tests which should not have been performed. However, without some evidence of conspiracy or something more than mere incompetency, the undersigned does not view the evidence as sufficient to draw such an inference. Without more than appears in this record, it is not logical to assume that Dr. Gonzalez benignly set out to profit Pembroke Pines General Hospital out of the "goodness" or "badness" of his heart. Further, the very fact that he fairly consistently avoided consultations with specialists suggests that this Respondent was not intending to enrich any third parties. (For the reasons stated herein, Petitioner's PFOF 63 is rejected). Respondent failed with respect to all of the above-named patients (excluding R.R., D.S., A.W., R.S., and O.A.) to practice medicine with that level of care, skill and treatment which is recognized as acceptable by a reasonably prudent similar physician under similar conditions and circumstances when he: admitted patients without justification; unnecessarily and inappropriately ordered tests for the patients which were not indicated by the patient's symptomatology; incorrectly diagnosed and conditions of patients he treated; inadequately documented the need for admission to the hospital and testing, inadequately documented the justification for his diagnoses and inadequately documented follow-up care; inappropriately prescribed Coumadin for patient L.M.; and excessively hospitalized two patients. (Adopts Petitioner's first PFOF 64). Respondents for the reasons previously enumerated failed to practice medicine within the prevailing standards of practice in the community. (Adopts Petitioner's second PFOF 64). Diagnoses are of great significance in a patient's care. They impact on the future well-being of the patient. Respondent, with respect to the records reflected above, failed to demonstrate adequate diagnostic ability. (Adopts Petitioner's PFOF 65).
Recommendation Based on the foregoing, it is therefore RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of violating Section 458.331(1)(n) and (t), Florida Statutes (Counts One and Two),and not guilty of violating Sections 458.331(1)(1) and (o)(Counts Three and Four), and suspending Respondent's license to practice medicine for a minimum of three years, with reinstatement conditioned upon proof of attendance and successful completion of courses selected by the Board of Medicine related to diagnosis and necessary record keeping. DONE and RECOMMENDED this 31st day of July, 1987, at Tallahassee, Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 1987. COPIES FURNISHED: Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Stephanie A. Daniel Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Robert A. Gonzalez, Jr. 1900 North Univeristy Drive Suite 110 Pembroke Pines, Florida 33024 Van Poole Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joseph A. Soled Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue Whether Respondent should be issued a Conditional rating from March 15, 2001, to June 11, 2001, based on surveys completed on March 15, 2001, and April 19, 2001.
Findings Of Fact Plantation Bay is a nursing home located in St. Cloud, Florida. Every fifteen months AHCA conducts a survey to determine if the facility is in compliance with applicable regulatory standards. During a survey, surveyors will observe and interview residents, observe care that is administered to residents, review medical records, and interview staff and family members. Based on the results of the surveys AHCA conducts, it determines whether the facility should receive a Standard or Conditional licensure rating. After AHCA completes the survey of a nursing home, it issues a report of its findings, commonly called a "2567," which describes any deficiencies found by the surveyors. The deficiencies are organized by "Tags." A Tag identifies the applicable regulatory standard that the surveyors believe has been violated and provides a summary of the violation, specific factual allegations that the surveyors believe support the violation, and two ratings which indicate the severity of the deficiency. One of the ratings identified in a Tag is a "scope and severity" rating, which is a letter rating from A to L with A representing the least severe deficiency and L representing most severe. The second rating is a "class" rating, which is a numerical rating of I, II, or III, with I representing the most severe deficiency and III representing the least severe deficiency. AHCA conducted a survey of Plantation Bay, on March 15, 2001, and alleged that there were three deficiencies, which it described under Tags F224, F309, and F332 of a survey report. AHCA assigned a state class rating of II and a federal scope and severity rating of G to both the F224 and F309 deficiencies. A scope and severity rating of "G" is one which AHCA determines is an isolated deficiency that caused actual harm (that is not immediate jeopardy) to a resident. AHCA assigned a state class rating of III and a federal scope and severity rating of E to the F332 deficiency. Based on its determination that there were two Class II deficiencies at Plantation Bay, AHCA changed Plantation Bay's licensing rating from Standard to Conditional, effective March 15, 2001. AHCA conducted a follow-up survey of Plantation Bay on April 19, 2001, to determine if the deficiencies cited on March 15, 2001, had been corrected. AHCA determined that the facility had corrected the F224 and F309 deficiencies but, based on new factual allegations, re-cited Plantation Bay for a deficiency under Tag F332. The F332 deficiency was assigned a Class III rating and a scope and severity rating of E. Because AHCA believed this deficiency had not been corrected, AHCA continued the Conditional rating at Plantation Bay. AHCA changed Plantation Bay's Conditional licensure rating to Standard, effective June 11, 2001. In the March 15, 2001, survey AHCA alleged under Tag F224 that Plantation Bay violated the standard contained in 42 CFR Section 483.13(c) and under Tag F309 that Plantation Bay violated the standard contained in 42 CFR Section 483.25. AHCA contends that Plantation Bay failed to provide appropriate monitoring and care to Resident 10 in relation to Tag F224 and failed to reduce the risk of potential decline and to maintain the highest practicable physical well being for Resident 10 in relation to Tag F309. Plantation Bay has procedures which the nursing staff are to follow when a resident has an elevated blood pressure level. The nurse is to continue to monitor the resident's blood pressure, notify the next shift of the resident's blood pressure, and contact the resident's physician if the resident's blood pressure continues to be elevated. Resident 10 was diagnosed with cardiovascular disease, cerebral vascular accident, hypertension, and cardiac dysrhythmia. She was prescribed 20 milligrams of Monopril every 12 hours. On March 2, 2001, a nurse measured Resident 10's blood pressure level at 210/90, which was a high reading for Resident 10. Standard nursing procedure called for the attending nurse to continue monitoring Resident 10's blood pressure and to notify the oncoming nursing staff and Resident 10's physician. The nurse failed to do any of these things. On March 4, 2001, Resident 10's family complained to Plantation Bay about Resident 10's cough and congestion. A nurse took Resident 10's temperature, but did not take Resident 10's blood pressure level. On March 12, AHCA's surveyor, in reviewing Resident 10's Vital Sign Flow Record, noted that from May 20, 2000, to March 2, 2001, the highest blood pressure recorded in Resident 10's Vital Sign Flow Record had been 184/72. The surveyor further noted that no further monitoring had been done since March 2, 200l. When the AHCA surveyor interviewed the nurse who had taken Resident 10's blood pressure level on March 2, 2001, and asked why no further monitoring had been done, the nurse replied that another emergency had occurred during her shift on March 2, 200l, and she had done nothing about the high blood pressure reading because it had "slipped her mind." On March 13, 2001, when the AHCA surveyor noted the lack of monitoring Resident 10's blood pressure level since March 2, 2001, she asked the nurse on duty whether she was aware that Resident 10 had an elevated blood pressure on March 2, 2001. The nurse replied that she was not aware of the elevated blood pressure. The nurse checked Resident 10's blood pressure, which was 202/82. The nurse indicated that she was going to contact Resident 10's physician. The surveyor asked what Resident 10's temperature was, and the nurse replied that she had not checked the temperature. Thirty minutes later, the nurse checked Resident 10's temperature and blood pressure. The temperature was 99.6 degrees Fahrenheit, and the blood pressure was 210/100. This information was sent to Resident 10's doctor. An hour and a half later, Resident 10's blood pressure was 210/90. Ninety minutes later, the blood pressure was 210/100. The information had been sent to Resident 10's doctor, but the doctor had not responded. Two and a half hours later, Resident 10 was sent to the emergency room by order of her physician. Resident 10's medication was changed to 40 milligrams of Monopril every 12 hours. An elevated blood pressure could worsen cardiovascular disease, cerebral vascular accident, hypertension, and cardiac dysrhythmia, conditions with which Resident 10 had been diagnosed. Thus, the failure of Plantation Bay on March 2, 2001, to monitor the blood pressure, to report the elevated blood pressure level to the oncoming shift, and to notify Resident 10's physician had a direct relationship to the health of Resident 10 and imposed an immediate threat to the health of Resident 10. AHCA also alleged under Tag 309 from the March 15, 2001, survey that Plantation Bay violated the standard of care set forth in 42 CFR Section 483.25. Plantation Bay failed to provide the necessary care for Resident 16 by not reducing the risk of potential decline and not maintaining the highest practicable physical well-being of each resident when it failed to monitor Resident 10's blood pressure on March 2, 2001, failed to notify the oncoming shift of the elevated blood pressure level, and failed to contact Resident 10's doctor. Resident 16 was admitted to Plantation Bay on February 10, 2001, following hospitalization for hepatic encephalopathy, secondary to cirrhosis of the liver, seizures, and falls. As a result of hepatic encephalopathy, the liver is unable to remove all the ammonia that it produces, and there is a risk that some ammonia will be introduced into the heart and brain. Prior to his admission to the hospital, Resident 16's ammonia level was 96. When Resident 16 was admitted to Plantation Bay, the ammonia level was 33, which is within normal range. Production of stool is important to reduce the absorption of nitrogen into the intestinal tract. On February 11, 2001, Resident 16's physician ordered 30 milligrams of Lactulose to be administered three times daily to produce at least three stools daily and to prevent hepatic encephalopathy. Plantation Bay administered the Lactulose to Resident 16 as ordered by the resident's doctor. According to Resident 16's Documentation Charting Record, the order text on February 10, 2001, was to "Monitor BMs & chart daily with O-S-M-L." Plantation Bay did monitor Resident 16's bowel movements and prepared a daily chart on the number and size of the bowel movements. Plantation Bay was not required to call the doctor if Resident 16 did not have three bowel movements a day. On February 11, 2001, Resident 16 had two bowel movements and one bowel movement on February 12, 2001. Blood tests on February 12, 2001, revealed that Resident 16 had an elevated ammonia level of 77, which is 17 points higher than normal. Plantation sent the test results to Resident 16's physician. The policy of Plantation Bay was to also place a copy of a laboratory report in the resident's chart. Resident 16's doctor went to the facility to see Resident 16 on February 13, 2001. The doctor did not change Resident 16's dosage of Lactulose nor did he make any notation about the number of Resident 16's bowel movements in the physician's notes. The charting records for Resident 16 show that from February 13 through March 15, there were 13 days when Resident 16 had no bowel movements, ten days in which Resident 16 had one bowel movement, five days in which Resident had two bowel movements, and one day in which there were three bowel movements. On April 5, 2001, Resident 16's physician stated in the Physician's Progress Notes for Resident 16 that Resident 16's ammonia levels had been fluctuating for four years, this was a chronic condition, and the fluctuation had nothing to do with the nursing care provided by Plantation Bay. He indicated that the ammonia levels were only a marker of the resident's condition. The nursing care provided by Plantation Bay did not cause the fluctuation in Resident 16's ammonia level and that the nursing staff followed the orders of the doctor in administering the Lactulose, monitoring the bowel movements, and charting the bowel movements daily. AHCA alleged under Tag F332 that Plantation Bay violated 42 CFR Section 483.25(m)(1), which requires that the facility is to be free of medication error rates of five percent or greater. AHCA contends that during the March 15, 2001, survey Plantation Bay had a medication error rate of 10.8 percent during observations of med passes on March 13, 2001. AHCA contends that during the April 19, 2001, survey that Plantation Bay had a medication error rate of 11.6 percent. In determining if a medication error has occurred, the surveyors observe a nurse as medications are administered to a resident, and then will look at the physician's orders to see if the medications are administered in accordance with the physician's orders. If a medication is administered but not ordered, it is counted as a medication error. If a medication is ordered but not administered, it is counted as a medication error. If a medication is not administered in accordance with the physician's order, it is also counted as a medication error. The errors are counted regardless of how significant they might be. The two AHCA surveyors who did the med pass observations for Tag F332 had extensive training in surveying and followed the procedures for surveying violations of Tag F332 as set forth by the Health Care Financing Administration (HCFA) in the Guide to Surveyors and Task E of the survey protocols, which provides: Initially observe a minimum of 20-25 opportunities for errors (opportunities are both the drugs been administered and the doses ordered but not administered). Strive to observe as many individuals administering medications as possible. This provides a better overall picture of the accuracy of the facility's entire drug distribution system. Ideally, the medication observation could include residents representative of the care needs in the sample, or the actual sampled residents. This would provide additional information on these residents, and provide a more complete picture of the care they actually receive. For example, if blood sugars are a problem, insulin administration may be observed. If eye infections are a problem, antibiotic eye drops may be observed, if residents are in pain, as needed pain medications may be observed, etc. Observe different routes of administration (i.e., eye drops, injections, NG administration, inhalation). If you found no errors after reconciliation of the pass with the medical records, this task is complete. If you found 1 or more errors, observe another 20 to 25, opportunities. The error rate is calculated by taking the number of errors observed and dividing it by the opportunities for errors and multiplying by 100. During the March 15, 2001, survey, an AHCA surveyor observed two medication errors during medication pass out of 24 opportunities for administration of medicine. These errors were the administration of 220 milligrams of iron when 325 milligrams were ordered and the administration of 25 milligrams of Colace when 100 milligrams were ordered. Colace is a stool softener. During the March 15, 2001, survey, another AHCA surveyor observed three errors out of 22 opportunities for administration of medicine. These errors were the omission of 20 milligrams of Pepcid to be administered once daily, the administration of 500 milligrams of Vitamin C when there was no physician's order, and the administration of two drops of Tobra Dex Opthalmic eye drops when one drop was ordered by the physician. During the April 19, 2001, survey an AHCA surveyor observed five errors out of 43 opportunities. These errors were failure to give Maalox with ibuprofen as ordered, administration of one drop of Gentamycin sulphate when two drops were ordered, administration of a multivitamin without iron when one with iron was ordered, administration of 1.20 milligrams of Prozac when 1.25 milligrams were ordered, and giving Lactolose after breakfast at 9:20 a.m. when it was ordered to be given before breakfast at 7:00 a.m. Plantation Bay challenges the methodology used by AHCA to determine the medication error rate. Plantation Bay's expert witness opined that a larger sampling would have to be used in order to get a more statistically valid error rate. According to their expert, a sampling of over 3,000 opportunities would be necessary in order to reach an error rate which was 80 percent correct. No evidence was presented to show the number of opportunities for administration of medications that the facility had in a day. Thus, it is not known if the facility even had 3,000 opportunities a day. The evidence failed to support Plantation Bay's expert's opinion that over 3,000 opportunities would have to be observed in order to accurately determine the medication error rate for Plantation Bay is credible. Contrary to the assertion of AHCA that the purpose of the med pass observations is to get a snap shot of one moment in time for the opportunities actually observed and not to make a projection as to what the error rate is for all the medication administrations in the building, Task E of the survey protocols makes it clear that the purpose of the med pass observations is to get a better "overall picture of the accuracy of the facility's entire drug distribution system." However, that error rate is obviously limited to the time of the survey. Given the short time period in which a survey is conducted, the methodology that is used to determine the medication error rate of the facility at the time of the survey is not fatally flawed. If the surveyor finds that an error occurs in observing the first 20 to 25 opportunities, the surveyor is to observe further opportunities to ascertain if there are errors in that group of observations. For the March 15, 2001, survey, Plantation Bay had a medication error rate of 10.8 percent. For the April 19, 2001, survey, Plantation Bay had a medication error rate of 11.6 percent. The Conditional Rating was effective from March 15, 2001, to June 11, 2001. No evidence was presented to establish when Plantation Bay was re-evaluated and a determination made that medication error was less than five percent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Plantation Bay receive a Conditional license from March 15, 2001, through June 11, 2001. DONE AND ENTERED this 2nd day of November, 2001, in Tallahassee, Leon County, Florida. ___________________________________ Susan B. Kirkland Administrative Law Judge Division of Administrative Hearings 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 this 2nd day of November, 2001. COPIES FURNISHED: Patricia J. Hakes, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310J St. Petersburg, Florida 33701 R. Davis Thomas, Jr. Qualified Representative Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302-1300 Diane Grubbs, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact Findings of fact set forth in the Recommended Order are approved and adopted and incorporated herein. There is competent substantial evidence to support the findings of fact.
Conclusions The Administrative Complaint has charged, concerning patient No. 1, that the Respondent failed to practice medicine with that level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The Respondent failed to perform the procedure to which the patient consented, a bilateral salpingo- oophorectomy. He did not document in the record that he informed or explained to her that the procedure was not performed and why. His records do not show why the procedure was or was not medically necessary. Additionally, he performed a D&C procedure which was not authorized by the patient; and the records contain no documentation of the fact that he informed her of performing that procedure nor the medical reasons why it was indicated, if it was. Because of this and because he failed to perform the procedure to which the patient had consented, the BS&O, without explanation in his records, it has been proven by clear and convincing evidence that the Respondent is guilty as charged in Count I of violating Section 458.331(1)(t), Florida Statutes, by departing from the medical practice standard mentioned in the paragraph above. It was not established, however, that he failed to inform the patient that the procedure which she consented to was not performed, the records merely do not show that she was informed. Moreover, although her eventual death from ovarian cancer stemmed from the organs which he failed to remove surgically when the patient had authorized them to be removed, it was not shown that they were in a cancerous or pre- cancerous condition at the time he performed the surgery or otherwise that the lethal cancer condition resulted directly from his failure to remove the organs at the time of the surgery some five years prior to the patient's death. It was not shown that he should, for some reason, have foreseen that the organs might become cancerous and ignored the risk or that their removal was then medically necessary. In light of the above Findings of Fact, which are supported by the clear and convincing evidence of record, it has been established that Section 458.331(1)(n), Florida Statutes (1979), now substantially reenacted as Section 458.331(1)(m), Florida Statutes, has been violated by the Respondent's failure to keep written medical records justifying his course of treatment of patient No. 1 by failing to document any reasons for his plan to perform the BS&O procedure, to document any symptoms or complaints by the patient, or to document why he changed his plans and did not perform the planned procedure authorized by the patient. This situation is distinguished from that of Breesman v. Department of Professional Regulations, 567 So.2d 469 (1st DCA 1990), which held that the above statutory section was not violated where a physician failed to document other courses of treatment which he elected not to employ. Here, the Respondent planned the BS&O procedure and then changed his plan during surgery. The basis for the change was unexplained in his records. He did not keep written records containing any description of the patient's fallopian tubes or ovaries, as observed during the operation, nor why he performed a D&C to which the patient had not consented, or why the procedures performed were not discussed with the patient. Concerning Count III, the Petitioner has shown by clear and convincing evidence, which culminated in the above Findings of Fact, describing in detail the Respondent's practice and treatment related to patient No. 2, that the Respondent is guilty of violating Section 458.331(1)(q), Florida Statutes, by administering the legend drug, marcaine, to patient No. 2 other than in the course of his professional practice. The administering of a legend drug inappropriately (here, by epidural catheter) or in excessive or inappropriate quantities (12 milliliters of a 0.75% solution in a patient described as, and under the circumstances of, the above Findings of Fact) was not in the best interest of patient No. 2 and was thus not within the proper course of the Respondent's professional practice. The inappropriate administration and the excessive concentration and volume of marcaine for patient No. 2 prescribed and administered under the circumstances delineated in the above Findings of Fact constitutes a violation of Section 458.331(1)(t), Florida Statutes, as charged in Count IV, because the Respondent has been proven by clear and convincing evidence to have failed to practice medicine with that level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under those conditions and circumstances in light of the above factual findings pertaining to this patient. Count V of the complaint involves the charge that the Respondent failed to keep written medical records justifying his course of treatment of patient No. 2. This is a violation of former Section 458.331(1)(n), Florida Statutes (1983), now substantially reenacted as Section 458.331(1)(m), Florida Statutes. The above Findings of Fact, supported by clear and convincing evidence of record, demonstrate that the Respondent failed to document any justification for using a highly-concentrated and dangerous agent, such as marcaine, in a volume which was excessive under the circumstances with which the patient presented (regardless of the allowable maximum dose indicated in a general fashion in the PDR). It was an excessive volume for a patient of this size and weight and medical circumstance, including the circumstance that she gave every indication of being able to accomplish a routine vaginal delivery and thus clearly did not need such an excessive volume and concentration of this drug, given the attendant risks, delineated in the above Findings of Fact, which, indeed, came to pass. The Respondent additionally failed to keep any anesthetic record concerning his evaluation of the patient, a description of his anesthetic technique, nor any justification for his anesthetic plan. Unrefuted testimony from an expert anesthesiologist (Dr. Cross) establishes that an obstetrician who prescribes, dispenses, and administers the anesthetic during a surgical, obstetrical procedure is held to the same standard with regard to anesthetizing patients, caring for patients, and documenting the anesthesia portion of his practice with regard to a patient, as is an anesthesiologist. In Count VI, the Respondent is charged with a violation of Section 458.331(1)(t), Florida Statutes, concerning patient No. 3. As delineated in more detail in the above Findings of Fact, the Respondent failed to take an adequate history and to document the performance of an adequate physical examination of this patient. He failed to correctly assess the patient's laboratory results, to obtain appropriate diagnostic studies and failed to adequately assess, monitor, or treat the patient's pregnancy-induced hypertension, as elaborated in greater detail in the above Findings of Fact. He failed to obtain an adequate or complete history and failed to perform an adequate physical examination. He did not adequately assess or monitor the pregnancy-induced hypertension, failed to adequately treat that condition, failed to order appropriate diagnostic studies to accurately determine fetal status prior to initiating therapy to prolong the patient's pregnancy, failed to adequately assess the patient's laboratory test results, and when there was evidence that the baby was in distress, failed to deliver the pregnancy immediately. The above Findings of Fact show, based upon clear and convincing evidence, that the Respondent prescribed, dispensed, administered, mixed or otherwise prepared legend drugs inappropriately or in excessive or inappropriate quantities, not in the best interest of the patient, by prescribing aldomet for the patient. This may have decreased placental perfusion or blood flow. Prescribing lasix for the patient also can decrease placental blood flow and create electrolyte imbalances. It was also inappropriate to prescribe yutopar to prolong the high-risk pregnancy and to prescribe a corticosteriod cream for the patient as treatment for her condition (swelling), which the Respondent had never diagnosed nor assessed. This amounts to prescribing, dispensing, administering, etc. legend drugs not in the course of the Respondent's professional practice, in violation of Section 458.331(1)(q), Florida Statutes. Concerning Count VIII of the complaint, clear and convincing evidence, supportive of the above Findings of Fact, established that the Respondent's written medical records do not justify the course of his treatment of patient No. 3, including, but not limited to, the patient's history, examination test results, and the failure to document any justification for the Respondent's failure to adequately assess, monitor and treat the PIH. They do not contain justification for the failure to order appropriate diagnostic studies to accurately determine fetal status prior to initiating therapy to prolong pregnancy; the failure to assess and diagnose the swelling and the failure to adequately treat the patient during the C-section. They contain inaccurate documentation to the effect that the patient had a "saddleblock" anesthesia, when other medical records reveal that it was an epidural anesthesia. The records do not document that the patient's laboratory test results were adequately assessed; and there is no documentation of either an initial assessment of the infant or his resuscitation efforts shortly after delivery. This recordkeeping deficit amounts to a violation of Section 458.331(1)(n), Florida Statutes (1981) (now Section 458.331(1)(m), Florida Statutes). Concerning Count IX of the complaint, for all of the reasons delineated in the above Findings of Fact with regard to patient No. 4, it has been demonstrated that the Respondent failed to practice medicine with that level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. This is shown by the failure to obtain an adequate or complete history, to perform an adequate physical examination on the various dates delineated above, to adequately assess, diagnose and treat the patient by failing to attempt a vaginal delivery, and the failure to obtain informed consent from the patient for sterilization prior to C-section. Additionally, the Respondent failed to adequately assess, diagnose and treat the lacerated cervix, and failed to adequately treat the patient during her postoperative recovery period. Thus, a violation of Section 458.331(1)(t), Florida Statutes, has been established by clear and convincing evidence in these particulars. It has also been so demonstrated that by prescribing the antibiotic, garamycin, without ordering attendant renal function studies (because of the potential for kidney damage) and by changing the route of that medication to a less effective means (oral), even though the patient remained febrile, amounts to prescribing, dispensing, administering, etc. a legend drug, other than in the course of his professional practice and inappropriately, for purposes of Section 458.331(1) (q), Florida Statutes (Count X). Concerning Count XI, it was established, as shown by the above Findings of Fact, that the Respondent failed to keep written medical records justifying the course of treatment of patient No. 4. He failed to document a complete history of the patient and failed to make an adequate or complete physical examination. He recorded no justification for the failure to attempt to deliver the patient vaginally; to document any justification for continued use of the nasogastric tube after the patient began eating; to document any justification for not ordering renal function studies with the use of the above- named antibiotic and failed to document any justification for changing the route of administration of that antibiotic in a febrile patient. He recorded statements in the discharge summary which are directly contradicted by the Respondent's statements in the medical records; and failed to document any explanation for the contradictory statements contained in these records. This constitutes a violation of Section 458.331(1)(m), Florida Statutes. Concerning Count XII of the complaint, the Petitioner has demonstrated by clear and convincing evidence, culminating in the above Findings of Fact, that the Respondent is guilty of unprofessional conduct, incompetence, and negligence, in violation of Section 458.1201(1)(m), Florida Statutes (1977), now incorporated into Section 458.331(1)(t), Florida Statutes (1989). Unprofessional conduct shall include any departure from or the failure to conform to the standards of acceptable and prevailing medical practice within a physician's area of expertise, as determined by the Board, in which proceeding actual injury to a patient need not be established when the same is committed in the course of a physician's practice. There is no question, given the above Findings of Fact, that the Respondent did not conform to standards of acceptable and prevailing medical practice within his area of expertise in his conduct of the care and treatment of patient No. 5. Thus, he has committed a violation of Section 458.331(1)(t), Florida Statutes.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, as well as the disciplinary guidelines and the consideration of aggravating and mitigating circumstances as provided for in Rule 21M-20, Florida Administrative Code, official recognition of which was taken; to wit, the exposure of the patient to injury or potential injury, the number of counts of separate offenses proven, and the disciplinary history of the licensee, it is therefore, RECOMMENDED that the Respondent be found guilty of violating Subsection 458.331(1)(g), Florida Statutes, as concluded hereinabove, with regard to Case No. 90-2680, but, in consideration of the above-referenced circumstances, that no penalty be imposed. With regard to Case No. 89-6489, it is RECOMMENDED that the Respondent be found guilty of violating the above enumerated subsections of Section 458.331(1), Florida Statutes, as concluded above, and that the Respondent's license to practice medicine in the State of Florida be revoked. DONE AND ENTERED this 9th day of September, 1991, in Tallahassee, Leon County, Florida. P. MICHAEL RUFF 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 9th day of September, 1991. APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 89-6489 and 90-2680 Petitioner's Proposed Findings of Fact Case No. 90-2680 1-5. Accepted. 6. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 7-8. Accepted. Rejected, as not in accordance with clear and convincing evidence. Accepted. 11-12. Accepted. 13. Rejected, as not in accordance with clear and convincing evidence. 14-20. Accepted. Case No. 89-6489 1-7. Accepted. 8. Rejected, as it was not established with clear and convincing evidence what the patient believed. 9-13. Accepted. 14. Rejected, as not entirely supported by the evidence and as subordinate to the Hearing Officer's findings of fact. 15-28. Accepted. 29-69. Accepted. 70-83. Accepted. 84-95. Accepted. 96. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 97-103. Accepted. 104-120. Accepted. Respondent's Proposed Findings of Fact Case No. 89-6489 Accepted, except as to time period noted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter and as not entirely supported by the evidence. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter and as not entirely supported by the evidence. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter and as not entirely supported by the evidence. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter and as not entirely supported by the evidence. Case No. 90-2680 Accepted, in part, but subordinate to the Hearing Officer's findings of fact. Accepted. COPIES FURNISHED: Dorothy Faircloth, Executive Director Board of Medicine Department of Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esq. General Counsel Department of Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Mary B. Radkins, Esq. Senior Attorney Department of Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Elliott F. Monroe, M.D. 2709 Arden Panama City, FL 32401
