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, based on alleged violation of Section 458.331(1)(t), Florida Statutes.
Findings Of Fact Respondent is a licensed physician in the State of Florida. He has been licensed in Florida at all times material to this proceeding. He currently holds license no. ME 0063272. Respondent has been practicing medicine for 20 years. He is certified by the American Association of Physician Specialist in Emergency Room Medicine. He has spent over 50,000 hours working in an emergency room setting and has never had his license suspended, revoked, or otherwise sanctioned. For approximately six to nine months in 1995-1996, Respondent was employed by a company which provided emergency room physicians to hospitals in the Central Florida region. On May 14, 1996, Respondent was providing services through that company at Glades General Hospital's emergency room. S.A.R. is a 69-year-old male. On May 14, 1996, S.A.R.'s wife called Emergency Medical Services (EMS), in connection with her husband, S.A.R. He was experiencing chest and epigastric pains. S.A.R. wore a nitroglycerin patch and had a history of heart disease. In response to the wife's call, EMS arrived at S.A.R.'s home. The emergency medical technicians (EMTs) noted that patient S.A.R. complained of severe chest pain and that he was cool and moist. The EMT's placed S.A.R. on a heart monitor. The heart monitor showed that S.A.R. was experiencing multifocal premature contractions (PVC's). Multifocal PVC's are a sign of an irritated heart. They are a risk factor for sudden cardiac death. S.A.R. was also experiencing abnormal, ectopic heartbeats consistent with heart disease. EMS gave S.A.R. Lidocaine and oxygen to reduce the irritability in his heart muscle and to suppress the abnormal heartbeats. At approximately 9:10 p.m., EMS transported S.A.R. to the emergency room at Glades General Hospital in Belle Glade, Florida. The Emergency Service Record concerning S.A.R. contains the following findings by the nurse who received the patient into the emergency room: Current medications: Axid 150 mg, Minitran 10 mg patch. Heart disease (Myocardial Infarction 20 years prior). Hernia. Patient complaining of epigastric pains since Friday (May 14 was Thursday). Pains come and go and are non-radiating. Skin is warm and dry, lungs are clear, and there is no respiratory distress. Oxygen is at 98 percent and there is strong pulse. Multifocal PVC "noted on cardiac monitor." Respondent was among the admitting team who evaluated the patient. Respondent noted that S.A.R. was experiencing severe pains located in the epigastric area with some radiation to the chest. The pains would last approximately five minutes and then fade away. Respondent also learned that S.A.R. had experienced the pain for approximately one week long and had gone to see his regular physician about the chest pain the day before he came to the hospital. His physician had prescribed Axid. Axid is a medication for indigestion. It takes some amount of time to become effective. Therefore it was not surprising to Respondent that S.A.R. had not gotten any relief 25 hours after he had begun taking the indigestion medication. Respondent took patient S.A.R. off the Lidocaine and ordered a GI Cocktail and a cardiac work-up. A GI Cocktail coats the stomach lining and reduces stomach spasms. It is intended to act quickly. A cardiac work- up consists of placing a patient on a heart monitor, monitoring vital signs, observing for arrhythmias, performing an EKG, and drawing blood tests for abnormal electrolytes and cardiac enzymes. A GI Cocktail will relieve chest pain. However, it will not normally alleviate cardiac pain in the chest area. In this case, all of S.A.R.'s pain and discomfort was relieved by the GI Cocktail, indicating that the epigastric pain was the reason for S.A.R.'s distress. The nurses notes indicate that at approximately 10:15 p.m., S.A.R. was experiencing multifocal PVC's on the monitor. The nurses notes indicate a more serious heart condition. The blood tests showed normal electrolytes and cardiac enzymes, indicating that S.A.R.'s heart was not the problem. Respondent did not find any evidence of a possible cardiac problem from his review of the patient's symptoms, from the test results, or by way of his personal observation of the patient. Respondent did not observe any multifocal PFC. He did observe that S.A.R.'s heart was not normal due to heart disease. Respondent diagnosed the patient with Gastritis, and released patient S.A.R. at approximately 10:30 p.m. The heart strips introduced into evidence did not show multifocal PVCs. They did show an abnormal heart beat consistent with heart disease. However, S.A.R. had numerous risk factors for a heart attack, including: Patient S.A.R. was a 69-year-old male. Patient S.A.R. suffered from coronary artery disease. Patient S.A.R. suffered a myocardial infarction approximately twenty years earlier. Patient S.A.R. was taking nitroglycerin for his heart condition as evidenced by a patch on his arm. Patient S.A.R. experienced multifocal PVC's on the cardiac monitor in the ambulance. Patient S.A.R.'s EKG taken in the hospital displayed unifocal PVC's and was abnormal, showing damage to two of the three electrical conduction bundles. Patient S.A.R. was cold and clammy when EMS first arrived. In this case, there is no way to know if S.A.R.'s pain was related to his heart. However, there is no way to rule out S.A.R.'s pain was caused by his heart. Approximately sixteen hours later, patient S.A.R. returned to the emergency room in full cardiac arrest. On May 15, 1996, seven and one-half hours later, he had another heart attack and died, of a myocardial infarction. There is no evidence that S.A.R.'s earlier emergency room visit was the cause of his later demise or that admission to the hospital would have prevented S.A.R.'s later demise. Petitioner's expert witness found that Respondent's treatment of S.A.R. was appropriate. That is, he ordered the proper test and treated the epigastric pain properly. In fact, his diagnosis that the problem was "GI in origin" was, according to Dr. Edelberg, statistically correct. Petitioner's expert concluded that Respondent could not rule out coronary ischemia and therefore should have tried to admit S.A.R. to the hospital for observation. The standard of care is for an emergency physician to evaluate a patient based on the worst case suggested by the symptoms even if statistically not the most probable. Based on patient S.A.R.'s past history and his current symptoms, the standard of care required Respondent to admit this type of patient into the hospital for observation. In failing to admit patient S.A.R. into the hospital for observation, the Respondent deviated from the standard of care required by a reasonably prudent similar physician under similar circumstances and conditions. Other than this one violation there is no evidence that Respondent is incompetent to practice medicine.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That Petitioner Department of Health, Board of Medicine enter a final order finding Respondent John Christopher Chauvin, M.D., guilty of violating Section 458.331(1)(t), Florida Statutes, and imposing upon the Respondent the following penalty: A Reprimand from the Board of Medicine and that Respondent, within two years take twenty-five hours of continuing education in the treatment of myocardial infarction in addition to any hours required for license renewal. DONE AND ENTERED this 12th day of May, 2000, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 12th day of May, 2000. COPIES FURNISHED: James Morrison, Certified Legal Intern Albert Peacock, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 R. Bruce McKibben, Jr., Esquire 1301 Miccosukee Road Tallahassee, Florida 32308 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703 William Langue, General Counsel Department of Health 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issues in this case are whether Petitioner committed the alleged violations and, if so, should her paramedic license be revoked.
Findings Of Fact At all times relevant to this proceeding, Petitioner was employed as a paramedic by the City of Gulfport and worked as a paramedic for the Gulfport Fire Department. In this capacity, Petitioner worked under the auspices of the medical director for Pinellas County Emergency Medical Services (Pinellas County EMS). Petitioner was a paramedic from 1997 until March 2003. Prior to that time, from 1991 until 1997, she worked as an emergency medical technician (EMT). On February 20, 2003, Petitioner, along with Lt. Brian Campbell and Firefighter/EMT Dennis Jackson, were called to respond to the scene of a shooting. Petitioner was the only paramedic on the scene and, therefore, the only person on the scene certified by the Office of the Medical Director (OMD) to provide advanced cardiac life-saving treatment. Petitioner received the call at 12:22 a.m., and arrived at the patient's side at 12:30 a.m. When Petitioner arrived at the patient's side, she observed a white male, approximately 20 years old, lying on his back in the street. His skin color was ashen, his mouth and eyes were wide open, and his pupils were fixed and dilated. Upon physical examination, Petitioner could not detect a pulse and observed two small holes in the patient's trunk. At that point, Petitioner did not know whether the two holes represented two separate entry wounds or one entry and one exit wound. Petitioner observed a trail of blood, at least a block long, leading to the patient, but there was not a lot of blood around the patient. Petitioner attached an electrocardiogram (ECG) monitor to the patient to monitor the electrical activity of his heart. When Petitioner first turned on the ECG monitor, she observed four ticks of electrical activity within a 14-second span. Petitioner testified that based on her observation and physical examination of the patient, she believed that the electrical activity exhibited on the ECG monitor was not pulseless electrical activity (PEA), but rather "artifact" caused by her manipulation of the patient. Petitioner further testified that, thereupon, she stopped touching the patient and observed that the ECG read-out went mostly flat, showing only occasional ticks. Petitioner testified that these occasional ticks, as observed on the ECG monitor, indicated to her that the patient was in asystole. Shortly thereafter, Petitioner declared the patient dead. After Petitioner declared the patient dead, she prepared a Patient Care Report (Report or Patient Care Report) while still on the scene. In the Report, Petitioner wrote that she found a white male laying on the ground with an apparent small entrance wound in his upper chest and a possible small exit wound near his back rib. She further noted that the patient's temperature was normal, that his eyes were fixed and dilated, that he was not breathing (apneic), and that he had no discernible pulse. Petitioner also noted in the Report that the patient was in asystole within one minute after the ECG pads were attached, but she failed to note the initial four ticks she observed, which may have represented PEA. In the Report, Petitioner noted that at 12:30 p.m., the patient was hooked up to the monitor; at 12:31 p.m., he was asystolic; and at 12:32, she confirmed the patient dead. Upon completing the Report at the fire station, Petitioner attached to the Report the last of several ECG strips she had intermittently printed while at the patient's side. The ECG printout that Petitioner attached to the Report depicted a classic "flat line" indicative of asystole or no electrical activity. Petitioner discarded each of the ECG strips that contained some indicia of electrical activity. A Patient Care Report is a legal document that Petitioner is required to complete by law. By signing the Report, Petitioner acknowledged that the information contained in the Report was true and accurate. Later, on the morning of February 20, 2003, when the employees' shifts at the fire station were changing, Petitioner and Toni Lanahan (Lanahan), a firefighter/paramedic coming on duty, talked about the shooting incident. That such conversation occurred is undisputed. However, there was conflicting testimony as to what Petitioner told Lanahan during that conversation. According to Lanahan, Petitioner told her that when she (Petitioner) arrived at the scene, the patient looked dead but she hooked him up to the ECG monitor, that he had a rhythm but she did not work him, and that she turned off the monitor. Petitioner testified that she did not tell Lanahan that the patient had a heart rhythm, but only that the patient "was dead" and that she did not work him.1 About two hours after her conversation with Petitioner, Lanahan retrieved stored ECG code summary data of the patient described above.2 When Lanahan reviewed the ECG code summary, she saw that the patient had a presenting ECG rhythm showing approximately 40 beats per minute of PEA with gradually slowing PEA for the entire seven minutes depicted in intervals on the ECG summary. Based on her review of the ECG record of the gunshot wound patient, Lanahan believed that in this situation, the OMD protocols mandated that immediate resuscitative treatment be administered. Lanahan then reported these concerns to her emergency medical services (EMS) Coordinator, Lt. Marenkovic, who in turn, reported the incident to Gulfport Fire Chief Brian Brooks. Chief Brooks notified the OMD of the possible violations of its protocols by Petitioner. The OMD initiated an investigation, which included reviewing the written statements of Petitioner, Lt. Campbell, and EMT Jackson; the ECG code summary for the incident; Petitioner's Report; and the transcripts of the sworn interviews of Petitioner, Lt. Campbell, and EMT Jackson taken by the Gulfport Fire Department. After reviewing the above-referenced documents, Dr. Laurie Romig (Dr. Romig), the medical director of the Pinellas County EMS, decided to revoke Petitioner's certification. This decision was based on Dr. Romig's determination of the following: (1) Petitioner violated numerous protocols in the Medical Operations Manual, both administrative and direct patient care protocols; and (2) Petitioner attempted to make the situation appear differently from what it turned out to be, and that, apparently, she did that on purpose. Specifically, Dr. Romig charged Petitioner with violating Pinellas County Emergency Medical Services Protocol 2.3, Sections 5 and 6, and Protocol 10.8 and the following Pinellas County Emergency Medical Services Rules and Regulations: Sections XIII-3-b, related to falsification or inappropriate alteration of emergency medical services records; XIII-3-e, related to theft or dishonesty in performance of duty; XIII-3-i, related to demonstrated ability, failure or refusal to adhere to established protocols and standards as established by the authority; and XIII-3-k, related to just cause, including unbecoming behavior or unprofessional conduct reflecting a poor system image. The Pinellas County emergency protocols are written requirements that paramedics must follow when administering emergency treatment to patients. The protocols are published in a document entitled Pinellas County Medical Operations Manual, which is approved by the medical director and distributed to all Pinellas County EMS paramedics. Petitioner received a copy of the most recent medical operations manual in January 2003. EMS Protocol 5.10 prescribes treatment for patients presenting with PEA. As defined in Protocol 5.10, PEA is "any semi-organized electrical activity that can be seen on a monitor screen although the patient lacks a palpable, radial, brachial, or carotid pulse." When PEA is present in a patient, Protocol 5.10 mandates that immediate life-saving treatment be implemented. The patient initially had electrical activity. Nonetheless, Petitioner did not follow Protocol 5.10. According to Petitioner's testimony, she believed that the patient was asystolic and, thus, the protocol related to PEA was inapplicable to the shooting victim. Petitioner's belief was not supported by the ECG report. Protocol 5.4 delineates the procedures to be followed in the treatment of asystole. In the book utilized for Pinellas County EMS paramedic training, "asystole" is defined as a cardiac arrest rhythm associated with no discernible electrical activity on the ECG ("flat line"). Significantly, Protocol 5.4 and Protocol 5.10, discussed in paragraph 21, require that resuscitative efforts be started immediately and that such resuscitative efforts and treatment be terminated by the paramedic only "after 10 minutes of continuous asystolic arrest with appropriate interventions." Even if Petitioner's assertion that the patient was asystolic is accepted, she failed to provide the required resuscitative efforts and/or treatments prescribed by Protocol 5.4. Petitioner did not prematurely terminate resuscitative efforts, she never implemented them. Protocol 5.15 prescribes the treatment and transport considerations for "patients with cardiac arrest secondary to trauma, regardless of presenting cardiac rhythm." The protocol provides that such patients should be transported to the closest hospital emergency facility. Contrary to the requirements in Protocol 5.15, the patient was not transported to a hospital emergency facility. Protocol 2.3 requires paramedics, when possible, to contact and consult with On-line Medical Control (OLMC) in any case in "which a deviation from protocol has been made intentional or otherwise." The OLMC is a system which allows paramedics to contact the OMD and consult with a medical doctor regarding a situation in the field. Petitioner clearly deviated from Protocols 5.4 and/or 5.10, by failing to initiate and implement the resuscitation procedures required by both protocols, and Protocol 5.15, by failing to have the patient transported to a hospital emergency facility, yet she never contacted the OLMC as mandated by Protocol 2.3. Petitioner acknowledged that she did not follow either Protocols 5.4 or 5.10, both of which required immediate resuscitative efforts. Petitioner testified that instead, she followed Protocol 10.8, which provides an exception to the protocols that require initiation of resuscitative efforts. Petitioner contends that Protocol 10.8 provided the basis for her withholding resuscitation from the patient. Protocol 10.8 requires that cardiopulmonary cerebral resuscitation (CPCR) be initiated "in all cases when the patient is found in cardiopulmonary arrest unless one of the exclusion or special situation criteria applies." The exclusion criteria provides that CPCR may be withheld if the patient has, "in conjunction with apnea, pulselessness and asystole on the ECG," an "obviously unsurvivable trauma." If CPCR is withheld, Protocol 10.8 requires that exclusion criteria be fully documented and described. Protocol 10.8 does not define "obviously unsurvivable trauma." However, according to Dr. Romig, the term connotes catastrophic injuries observable by an untrained eye. Dr. Romig, an expert in emergency medicine and traumatic cardiac arrest, testified that nothing about this patient, based on her review of the records and documents, indicated that the patient had suffered an "obviously unsurvivable trauma." Also, Lt. Campbell, an EMT certified for 12 years, who was at the scene, testified that although the patient "looked dead," he could not say that the patient suffered an "obviously unsurvivable trauma" because the patient showed only a small bullet wound to the chest and a "little bit" of blood on his (the patient's) clothing. The weight of the evidence showed that the patient had not suffered an obviously unsurvivable trauma. However, even accepting Petitioner's testimony that she believed that the patient had suffered an obviously unsurvivable trauma, she failed to comply with Protocol 10.8. If Petitioner, in fact, relied on Protocol 10.8 in deciding to not administer CPCR, she was required to document and describe the exclusionary criteria, which was the basis of her decision to withhold CPCR. Petitioner failed to provide any such documentation and, thus, violated Protocol 10.8. In addition to violating the above-noted protocols, Petitioner was dishonest in the performance of her duties as a paramedic and also falsified EMS records. The ECG summary showed that despite the patient's having electrical cardiac activity of at least 40 beats, Petitioner turned off the ECG machine and pronounced the patient dead. After pronouncing the patient dead, she then turned the ECG machine on again, and intermittently printed activity on four separate occasions until reaching a reading showing no electrical cardiac activity. By engaging in this conduct, Petitioner was dishonest in the performance of her duties. Paramedics are required to truthfully and accurately complete the Patient Care Records of patients for whom they provide emergency medical services. Here, the ECG summary showed PEA of over 40 beats per minute initially and diminished electrical activity for over eight minutes total, six minutes of which were after Petitioner had already pronounced the patient dead. Petitioner initially saw a rhythm of four beats or ticks in a 14-second period, which was a beat rate of 40 and showed on the ECG strip as 42. Although the initial reading of approximately 40 beats and PEA was clearly visible during the entire nearly eight minutes depicted on the six-second intervals shown on the ECG code summary, this was omitted from Petitioner's Report. Petitioner omitted from the patient's Record the ECG readings that showed electrical activity. Instead, Petitioner reported that at the time she declared the patient dead, he was in "asystole" when, in fact, the ECG summary showed PEA. Moreover, Petitioner documented the Report with an asystole ECG strip reflecting a "flat line" reading printed some six or seven minutes after the reported time of death.3 Petitioner admitted during her sworn statement and at this proceeding that she deliberately did not attach to the Report any part of the ECG strip that reflected the interim electrical activity. Petitioner testified that the ECG strips showing interim electrical activity could raise doubts about the propriety of the treatment she gave this patient in a future criminal trial or other investigation.4 The medical director is required by law to ensure that Pinellas County EMS personnel provide quality care and are not a danger to the safety of the county's citizens, residents, or visitors. Here, Petitioner violated the protocols related to the standard of care for patients and completion of reports and rules and regulations related to dishonesty in the performance of duties and to falsification of records. These infractions are a possible threat to public health and safety of residents of and visitors to Pinellas County. As such, they constitute just cause to conditionally revoke Petitioner's Pinellas County Paramedic Certificate. The conditional revocation allows Petitioner to reapply for a paramedic certificate in two years. Such recertification may include a one-year probationary period, with monitoring by the medical director to include a review of all trauma-run reports. Petitioner's Pinellas County Emergency Medical Technician Certification was not revoked and she retains that certification.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that Respondent enter a final order finding Petitioner guilty of the violations alleged in the Notice of Revocation dated March 28, 2003, and upholding revocation of Petitioner's Pinellas County Paramedic Certificate. DONE AND ENTERED this 1st day of October, 2003, in Tallahassee, Leon County, Florida. S CAROLYN S. HOLIFIELD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of October, 2003.
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
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
The Issue The issues in this case are whether Respondent violated Section 458.331(1)(m), and/or (1)(t), Florida Statutes (Supp. 1996), and, if so, what discipline should be imposed.
Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings of fact are made: Findings regarding the parties The Board of Medicine (Board) is the regulatory board within the Department of Health that is responsible for the regulation of the practice of medicine in Florida. Respondent is, and was at all times relevant to this proceeding, a licensed physician, Board-certified in plastic surgery. His license number is ME 0030449. At all times relevant to this proceeding, Respondent practiced at the Florida Center for Cosmetic Surgery (FCCS), which was an office surgery center in Ft. Lauderdale, Florida. Respondent performed cosmetic surgery at FCCS about two to three days a week while still maintaining his own office surgery center in Winter Park, Florida, where Respondent currently practices. From the beginning of the professional relationship between Respondent and FCCS, it was contemplated by all concerned that the relationship would be a part-time, short-term relationship; Respondent was merely providing plastic surgery services and follow-up care on a temporary basis until FCCS could make a more permanent arrangement with a plastic surgeon who wanted to work full-time for FCCS. Respondent never had any role in the business practices of FCCS, never had any managerial role at FCCS, and never had any ownership interest in FCCS. The agreement between Respondent and the principals at FCCS included an understanding that all patients who sought services at FCCS were patients of the clinic; not patients of the individual surgeon who performed the surgery on a patient. Consistent with that understanding, FCCS also insisted that it was entitled to custody and control of all of the medical charts, and Respondent was not allowed to remove any medical charts from the premises of FCCS. Respondent performed surgery at FCCS for approximately six weeks. General findings about the relevant surgical procedures A brow lift is a cosmetic surgery procedure that involves an incision in the patient’s scalp. The incision goes quite deeply into the forehead. After the incision, the scalp is dissected and loosened all the way down to the eyebrows, with the intent of this procedure being to raise up the eyebrows to some degree to give a rejuvenated appearance to the forehead. The incision in the scalp bleeds easily. In order to minimize the scalp bleeding, an electrocautery device is used for cauterization at the site of the bleeding. An electrocautery device may either be monopolar or bipolar. A monopolar cauterization device utilizes a “grounding plate” or a “grounding pad” to ground the electric current. The grounding plate or pad is attached to the patient on a fleshy part, typically along the side of a patient’s thigh or on a patient's buttock, away from any bony prominence. "Bovie" is the trade name of a major brand of monopolar cauterization devices. The grounding plate or grounding pad for a monopolar cauterization device is commonly referred to as a "Bovie pad." In contrast, a bipolar cauterization device does not need and does not have a grounding pad. Liposuction is a medical procedure in which fat is removed from an area of a patient's body by means of a suction device. A cannulus, which is a narrow tube with a sharp tip, is inserted into the desired areas of the body. The cannulus is connected to a vacuum-like device and once the cannulus is inserted into the operative area, it is manually maneuvered by the physician to remove the fat within reach of the cannulus with vacuum suction. General findings about Patient F. V. This case arises from surgical procedures performed by Respondent on February 6, 1997, on a patient identified in the record of this case as Patient F. V. Patient F. V. is a white female, who at the time of the relevant surgery was 43 years old. Patient F. V. wished to improve her facial features and wished to reduce the fat in her thighs. She went to FCCS to seek cosmetic surgery for those purposes. Patient F. V. had previously undergone cosmetic surgery performed by Dr. Myron Persoff, also at FCCS, on August 23, 1995. Pre-operative contact between Patient F. V. and FCCS On January 28, 1997, Patient F. V. contacted FCCS (probably by telephone) and someone at FCSS filled out a consultation form about that contact. The form listed the requested procedures of a facelift/browlift and liposuction. The form also noted a prior facelift by Dr. Persoff, a plastic surgeon also with FCCS. Finally, the form indicated a confirmation note of January 29, 1997, for an appointment date and time of January 30, 1997, at 3:00 p.m. On January 30, 1997, Patient F. V. went to FCCS for consultation regarding cosmetic surgery. On that date, Patient F. V. filled out a “Patient Information” form. The form asked Patient F. V. basic questions relating to her medical history and relating to her social history. Patient F. V.’s next visit to FCCS was on February 3, 1997. February 3, 1997, was the first and only time that Respondent met with Patient F. V. prior to the surgery on February 6, 1997. On February 3, 1997, a presurgical and anesthesia evaluation form was completed by Certified Registered Nurse Anesthetist (CRNA) Charlotte Filip. This form detailed some history of Patient F. V. and listed the prior surgery to the breast, face, and eyes. The Patient and Nurse Filip signed the form. During Patient F. V.’s February 3, 1997, visit to FCCS, Respondent conducted an initial physician/patient consultation. During the course of the consultation on February 3, 1997, Respondent conducted a thorough pre-operative consultation with Patient F. V. His activities during that consultation included taking a history and conducting a physical examination. Respondent discussed with Patient F. V. what she wished to have done, and he also discussed with her the risks and benefits of the proposed procedures. During the course of that consultation Respondent made a plan for the surgical procedures to address Patient F. V.'s concerns and desires. Thereafter, Respondent approved Patient F. V. for a brow lift and thigh liposuction. At the conclusion of the consultation on February 3, 1997, Respondent dictated a pre-operative report. The transcription of that dictation is not in F. V.'s medical chart maintained at FCCS. The fate of that dictated pre- operative consultation report is presently unknown.6 At the time of the Patient F. V.'s 1997 surgery, it was the practice of FCCS to prepare, and to maintain in the patient's medical records, a financial check list. For reasons not explained in the record in this case, the financial check list for Patient F. V.'s 1997 surgical procedures is missing from Patient F. V.'s medical chart at FCCS. At that same time, it was also the practice at FCCS for the physician to either provide the patient with pain medications or with a prescription for pain medications prior to surgery, and to document such delivery of medications or prescription for medications in the patient's medical chart. For reasons not explained in the record in this case, such documentation is missing from Patient F. V.'s medical chart at FCCS. At the time of Patient F. V.'s 1997 surgery, it was also the practice at FCCS to provide each patient with a pre- surgery instruction sheet listing numerous things the patient should do prior to surgery, as well as things the patient should not do prior to surgery. It was also the practice of FCCS to place a copy of the instruction sheet in the patient's medical chart. For reasons not explained in the record in this case, the copy of the instruction sheet given to Patient F. V. is missing from her medical chart at FCCS. At the time of the pre-operative consultation on February 3, 1997, FCCS was experiencing delays with the transcription of dictated reports. Such transcriptions often took as long as one or two weeks. Some of the information generated at the pre-operative conference needed to be promptly communicated to the financial staff at FCCS so that the costs of the procedures to be performed could be determined and so that arrangements for payment could be made with the patient. In some manner not presently remembered, Respondent provided the FCCA financial staff with the information they needed to make the necessary financial arrangements with Patient F. V.7 Patient F. V.’s medical records at FCCS do not contain adequate documentation of Respondent’s pre-operative consultation on February 3, 1997, with Patient F. V. Further, Respondent could not produce any adequate documentation of his February 3, 1997, consultation with Patient F. V. Day of Patient F. V.’s surgery Respondent performed surgery on Patient F. V. on February 6, 1997, which consisted of a brow lift and liposuction of her thighs. Before Respondent began the surgical procedure, CRNA Filip (Nurse Filip) conducted her own physical assessment of Patient F. V. for her purposes as the anesthetist. Nurse Filip also documented the results from the lab tests. Nurse Filip documented her results by hand writing notes on the bottom left portion of the Pre-Operative Checklist. As evidenced by the anesthesia record in Patient F. V.’s records, Nurse Filip also performed her duties as the anesthetist for the surgery and documented her pre-operative care of Patient F. V. In the anesthesia record, Nurse Filip documented information including a cursory patient history (allergies, medication being taken, and blood pressure), date, type of surgery, and surgeon. Respondent had no part in documenting any information on the anesthesia records. The anesthesia records for Patient F. V.'s surgery on February 6, 1997, appear to be complete. The circulator who participates in a surgical procedure has the recordkeeping responsibility of creating an operating room record, which should include a detailed description of the equipment used during the surgical procedure, as well as an itemization of all significant events from the time the patient enters the operating room until the patient goes to the recovery room. During 1997 it was the practice of FCCS to keep the circulator's operating room records in the patient's medical chart. For reasons not explained in the record in this case, the circulator's operating room record is missing from Patient F. V.'s medical chart at FCCS. The progress note for the day of surgery, February 6, 1997, is a de minimus notation that lists little more than the type of surgery performed, the surgeon's name, the weight of the patient, the names of the scrub nurse, the circulating nurse, and the CRNA, and the total amount of fat removed. This de minimus progress note is not in Respondent's handwriting.8 In addition to a progress note summarizing the basic details of a surgical procedure, once the surgery is complete the surgeon should also prepare a detailed operative report which describes in detail the manner in which the surgical procedure was performed, including all significant events that occurred during the surgery. Such an operative report should include a description of the type of liposuction and the type of brow lift performed. Such an operative report should also detail the manner in which the surgery was performed and should note any burns, injuries, or other complications arising from the surgery. A sufficiently detailed operative report is especially important in the event of post-operative complications, because details regarding the methods and techniques employed during the surgery can often facilitate an understanding of, and facilitate treatment of, any post- operative complications. There is no clear and convincing evidence as to whether Respondent did or did not prepare a detailed operative report of the type described in the immediately preceding paragraph. What is clear is that such an operative report is missing from Patient F. V.'s medical chart at FCCS.9 Respondent's recollection of the details of the subject surgery on February 6, 1997, is not very good. Although he seems to have a clear recollection of some details, he does not appear to recall some other equally important details. He does, however, remember that after the surgery he wrapped Patient F. V.'s forehead with Ace wrap and placed a strip of tape along the forehead to immobilize the Ace wrap. He also applied Ace wrap to the patient's thighs at the conclusion of the surgery. The Ace wraps on the thighs were also secured with strips of tape. At the conclusion of the surgical procedures on February 6, 1997, there were no visible blisters at the locations where blisters were visible on February 7, 1997. During the surgical procedures performed on February 6, 1997, on Patient F. V., Respondent did not use a monopolar catherization device. Therefore, no grounding pads were used during that surgery. Findings regarding post-operative care FCCS’s post-operative policy in effect in February of 1997 required the patient to return for post-operative follow up as follows: one day, one week, two weeks, and one month. Patient F. V. returned the next day, February 7, 1997, and was seen by Respondent. On February 7, 1997, the patient’s head dressing was removed, the bandages on the patient's thighs were removed, and the patient was advised to follow up in 5 days to have sutures removed. Respondent’s notes for this visit included a notation that the patient was "doing great," and that the patient should return for staple removal. Respondent's notes also mention a "forehead blister" which is noted to be "clean," and a "tape blister" on the left thigh. On February 7, 1997, Patient F. V. had a blister on her left thigh. This thigh blister was located on the front of the thigh, a few inches above the kneecap. On February 7, 1997, the patient also had a smaller blister on her forehead above her left eye.10 Respondent’s post-operative progress note of the February 7, 1997, visit does not document a treatment plan for the injuries on the forehead or the thigh. However, in this regard it must be noted that there is no evidence that either blister required treatment on February 7, 1997, or that either blister appeared to require any future treatment other than follow-up observation.11 Patient F. V. returned to FCCS on February 13, 1997, and was seen again by Respondent. The written progress note for that day recorded her weight, but no other subjective or objective complaints were noted. The progress note mentions a "possible tape blister" on the patient's upper left thigh. On this occasion the top of the thigh blister had come off and an unprotected layer of skin was at that site. The thigh blister needed treatment to prevent infection. The progress note also mentions that Bacitracin, an antibiotic, was applied to the thigh blister and that the blister site was covered by a 4” x 4” piece of gauze held in place by a small piece of paper tape. There are no notes concerning the lesion on the forehead. In this regard it must again be noted that there is no evidence that the forehead blister required any treatment at the time of this visit.12 Patient F. V. was advised to come back in one week to have the staples removed. The next entry in the progress notes states that Patient F. V. returned three days later, on February 16, 1997. Although the matter is not entirely free from doubt, the visit recorded as having occurred on February 16, 1997, probably actually took place on February 17 or 18, 1997.13 The progress note for that visit first notes that the patient was happy. It also notes that the stitches and the staples were removed. The progress note concludes with the following: "Script given for Silvadene 1% due to burn on leg and forehead." It is not clear from the progress notes who saw the patient at this visit, but it was probably one of the physicians (other than Respondent) who worked at FCCS, inasmuch as a prescription was written during this visit. Both Bacitracin and Silvadene were appropriate antibiotics for the patient's thigh and forehead lesions. Silvadene has a more penetrating quality to it and can penetrate scabs better. On February 24, 1997, Patient F. V. called the FCCS regarding the lesion on her leg. A dermatologist friend of hers had advised her to discontinue the Silvadene cream and to contact her physician about the lesion. Patient F. V. wanted Respondent to see her. She was advised to come in the next day to see one of the other physicians employed at FCCS. The next day (February 25) Patient F. V. returned to FCCS for further follow up treatment. She was seen by Dr. Alexander, one of several physicians employed by FCCS, who advised her to leave the lesion dry and see how it heals. The lesion on the thigh was described as "dry and scabbed." The patient was very unhappy during this visit. On February 26, 1997, Patient F. V. returned to FCCS and was seen by Respondent. Respondent noted that she was doing very well “except for left leg burn.” Respondent also noted as a possible cause of the lesion on the patient's left leg: “probable ground plate sensitivity.” There are no subjective complaints recorded. The record also does not contain any type of plan concerning the left leg burn. In this regard it should be noted that on the previous day Dr. Alexander had advised the patient to leave the burn dry and see how it heals. In all probability, during the following 24-hour period there was no change to the lesion on Patient F. V.'s thigh that required any additional treatment plan other than the "wait and see" plan noted by Dr. Alexander the day before. Photographs were taken on the visit of February 26, 1997. There are several post-operative photographs of the left leg lesion. On March 20, 1997, Patient F. V. returned to FCCS and was seen by Respondent. Respondent noted that she was doing better and that her leg lesion was improving. There are no clearly documented objective or subjective complaints. There is no plan documented other than return ASAP. Respondent’s medical record of March 20, 1997, does not document a plan for the course and scope of treatment for Patient F. V. Although Respondent documents a concern with the forehead, he did not document what concerns he had or how he planned to treat the concerns.14 After the visit of March 20, 1997, Patient F. V. did not return to the FCCS for over a year. On June 4, 1998, Patient F. V. was seen by two physicians at FCCS. Both physicians examined Patient F. V. and then prepared progress notes reporting what they had observed and proposing a plan to address what they had observed. Respondent discontinued his professional relationship with FCCS on or about April 1, 1997. Prior to leaving FCCS, Respondent reviewed all of his charts and had the opportunity to make sure all the histories and physicals were complete. To the best of Respondent's recollection, when he left FCCS there were no charting problems in any of the medical charts of any of the patients who had been treated by Respondent at FCCS. Patient F. V. returned to FCCS on June 4, 1998, and was seen by Dr. Alexander. Dr. Alexander was another plastic surgeon who worked at FCCS. Following his examination of Patient F. V. on June 4, 1998, Dr. Alexander prepared a progress report reading as follows: "6/4/98. Depressed area above the left eye on the forehead, dime size. Second degree burn, one- inch long depigmented burn scar left medial thigh. Also two- inch wide scar, medial forehead lift scar. Plan, revise all scars." On June 4, 1998, patient F. V. was seen by another physician identified in progress notes as "Dr. H."15 Following his examination of Patient F. V. on June 4, 1998, the second physician ("Dr. H") prepared a progress note reading as follows: Dr. H, 6/4/98 1.7 x .8 centimeter hypopigmented scar with surrounding hypopigmentation 2mm. flat non-tender .8 x .6 centimenter thin skin left upper forehead appears like lower dermis mobile to touch but doesn't animate on her own. Can't really see scar - just notice conture deformity. Rec - Excise leg scar vertically. ? Alloderm under depressed scar left forehead. Discuss with patient. G.L.A.D. Patient F. V. has elected not to have scar revision surgery. When Respondent discontinued his professional relationship with FCCS, he left all of the medical records concerning his care and treatment of Patient F. V. in the possession and custody of FCCS. Respondent did not take any copies of any medical records concerning Patient F. V. when he discontinued his relationship with FCCS. It was not until the latter part of 1999 that Respondent first obtained possession of a copy of the FCCS medical records concerning Patient F. V. He obtained those copies by means of a discovery request. As of the time of the final hearing in this case, several documents were missing from the medical records concerning Patient F. V. maintained by FCCS. The missing documents included the following: a detailed pre-operative report; a detailed operative report prepared by Respondent or prepared by someone acting pursuant to Respondent's direction and control; a financial check list; written documentation of medications provided to or prescribed for the patient; and a sheet of pre-surgery instructions regarding what the patient should and should not do. At several times during the period from 1998 through 2002, the medical records at FCCS concerning Patient F. V. were searched in an effort to locate a detailed pre-operative report and/or a detailed operative report. Such documents could not be found in the FCCS records on those occasions. Without an operative note (or some other form of detailed information regarding the manner in which the surgical procedures at issue were performed) it is virtually impossible to reach a reliable determination as to what caused the injuries on the patient's left thigh and forehead. On the basis of the record in this case, the causes of the forehead and thigh lesions observed on Patient F. V. on February 7, 1997, are unknown. Because the causes are unknown, it is also unknown whether such lesions were caused by act or omission by Respondent. And, because no specific act or omission by Respondent has been identified as the cause of either lesion, it is impossible to determine whether any such unidentified act or omission, if any, might or might not have constituted a departure from the applicable standards of care. There is no clear and convincing evidence that Respondent "fail[ed] to properly administer liposuction, causing full-thickness burns to Patient F. V.'s left thigh area." There is no clear and convincing evidence that Respondent "fail[ed] to properly perform the brow lift, causing full-thickness burns to Patient F. V.'s forehead." There is no clear and convincing evidence that Respondent "improperly plac[ed] or fail[ed] to appropriately supervise the placement of the grounding pads of the Bovie unit." There is no clear and convincing evidence that Respondent did "not adequately maintain[ ] his surgical equipment relating to liposuction and brow lift procedures." There is no clear and convincing evidence of Respondent's "failing to properly document Patient F. V.'s preoperative consultation." There is no clear and convincing evidence of Respondent's "failing to properly document a post-operative report of the procedures." There is no clear and convincing evidence of Respondent's "failing to complete or create an appropriate operative report for the procedures."
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine issue a final order in this case dismissing all parts of both counts of the Amended Administrative Complaint because none of the violations alleged in the Amended Administrative Complaint have been proved by clear and convincing evidence. DONE AND ENTERED this 31st day of December, 2003, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH 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 31st day of December, 2003.
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of August, 2005.
