The Issue The issue is whether Respondent is guilty of failing to practice medicine in accordance with the applicable standard of care by failing to assess adequately a patient's complaints, failing to provide an adequate diagnosis, failing to obtain a specialized consultation, and failing to pursue the appropriate treatment, in violation of Section 458.331(1)(t), Florida Statutes, and failing to keep adequate medical records to justify the use of Cardizem and document the drug's effect, in violation of Section 458.331(1)(m). If guilty of either of these offenses, an additional issue is the penalty that should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 0048483. He is Board Certified in Emergency Medicine. On May 16, 1994, shortly after 2:00 PM, a 48-year-old male presented at the Naples Community Hospital emergency room with the chief complaints of a rapid heart rate and shortness of breath. He felt warm, but denied feeling nauseous or chest pain. He also reported that he had not had any previous cardiac problems or any head trauma. The patient's heart rate was rhythmic, though rapid at 132 beats per minute. His respiration rate was 24, and his blood pressure was 110/80. The nurse initially examining the patient applied a pulse oximeter and obtained an abnormally low reading of 70 percent on room air. The patient's grey color confirmed that this was not an erroneous reading. The nurse immediately placed the patient on oxygen. After the oxygen was started, Respondent saw the patient, whom he found not to appear sick. The patient's breathing, though rapid, was not labored. He explained that he had come to the hospital only at the insistence of his employer. Evidently, his color had quickly improved with the administration of oxygen. Thinking that this might be a case of tachycardia, which can cause a sensation of shortness of breath, Respondent appropriately ordered a chest x-ray, EKG, and cardiac labs. Respondent received the chest x-rays promptly. They were normal, precluding, among other things, a collapsed lung. The cardiac labs were also normal. Respondent ordered two more EKGs during the patient's hospitalization on May 16. The parties disagree as to the significance of the results of the three EKGs, which revealed some abnormalities. Petitioner failed to prove that the abnormalities revealed in the EKGs were material to a correct diagnosis. Respondent's expert testified that these abnormalities were common among adults and nonspecific. He added that they did not reveal that the patient was suffering from a pulmonary embolism. This detailed, unqualified testimony from an experienced physician is credited over the testimony of Petitioner's expert. Respondent ordered an intravenous access, which was established at 3:00 PM. Although still receiving oxygen, the patient's oxygen saturation was at 97 percent at 2:45 PM and 4:00 PM. Based on his tentative diagnosis of tachycardia, Respondent administered 20mg of Cardizem at 3:35 PM. Cardizem is a calcium channel blocker, which slows down the heart rate. Generally, the patient's condition improved following the administration of the oxygen. According to the nurses' notes, the patient's breathing had slowed down by 2:45 PM, and he reported that he was feeling better by 4:45 PM. Respondent saw the patient four times during his hospitalization and confirmed for himself the nurses' observations before discharging the patient by 6:00 PM. Respondent's discharge diagnosis was paroxysmal supraventricular tachycardia--resolved. He later amended the diagnosis to sinus tachycardia, but testified that he still would have discharged the patient with this diagnosis, under all of the circumstances. The patient returned to the hospital at 10:00 AM the next day, effectively dead on arrival. He had suffered an acute pulmonary saddle embolus. The sole question in this case turns on the adequacy of Respondent's diagnosis and treatment on May 16. Petitioner's expert conceded that there were no independent issues involving the adequacy of the medical records, and Petitioner's proposed recommended order makes no mention of this alleged violation. In hindsight, it is impossible to attribute to mere chance the events of May 16 when the patient died the next morning from an acute pulmonary saddle embolus. Something happened at work, and probably was still happening when the patient first arrived at the hospital, and this was related to what killed the patient the following day. However, Petitioner has not proved that whatever happened to the patient persisted long enough for Respondent to be able to diagnose it based on the data available to him on May 16 or, even if it had, that Respondent's failure to diagnose it was a departure from the applicable standard of care. The first potentially important piece of information collected by the hospital, apart from this history, was the abnormally low pulse oximeter reading. However, Petitioner failed to prove that Respondent was aware of this information, or reasonably should have been aware of this information, at the time that he was treating the patient. The hospital had recently instituted the practice, since discontinued, of separating the nurses' notes, where the low reading was recorded, from the remainder of the medical records for a patient. Ensuing pulse oximeter readings, of which Respondent was aware, were recorded in a different place in the records from the initial pulse oximeter reading. Moreover, it is unclear whether, if Respondent had been aware of the patient's abnormally low pulse oximeter reading, this knowledge would have materially changed what Respondent had to do to meet the applicable standard of care. Ensuing pulse oximeter readings were 96 and 97 percent. Prior to discharge and after discontinuation of the oxygen for a suitably long period of time to eliminate its effects, the patient's pulse oximeter reading remained in the high 90s. Petitioner's expert witness conceded that the pulse oximeter is not a diagnostic tool for a pulmonary embolism. He testified that the EKGs were not a diagnostic tool for a pulmonary embolism, but would give hints of this condition. His main argument was that the initial pulse oximeter reading of 70 percent at room air should have been followed by an arterial blood gas test, which "probably" would have been abnormal. An abnormal arterial blood gas reading should have been followed by a VQ scan, which he asserted should have been abnormal due to little emboli coming off the lungs. However, there is a large element of speculation in the testimony of Petitioner's expert concerning these two tests. It is as likely as not that the arterial blood gas results would have been normal. The VQ scan would almost certainly have been normal, as the autopsy revealed no profusion of emboli, but only an acute pulmonary saddle embolism as the cause of the patient's death. Respondent's expert conceded that a pulmonary arteriogram probably would have been useful, but, in 20 years' practice, he could not recall ordering such a test, which is relatively frequently done in large academic institutions, but not in community hospitals, due to the mortality associated with the procedure and the 2-3 percent of false negatives. Additionally, this record does not so clearly disclose the relationship between the incident on the afternoon of May 16 and the death on the morning of May 17 to permit even an inference that a pulmonary arteriogram would have detected an abnormality in the interim between these two points. Perhaps the most important fact in evaluating whether Respondent met the applicable standard of care is that the patient exhibited none of the predisposing factors for a pulmonary embolism. He had no cardiopulmonary disease. He had no chronic obstructive pulmonary disease. A cable television installer, he was not sedentary and had no stasis of the blood flow, such as from a prolonged immobilization. He was not obese. He had no relevant trauma or injury to the lower extremities. The diagnosis of a pulmonary embolism is very difficult even with predisposing factors; in the absence of such factors, the diagnosis is dauntingly difficult. As Respondent's expert testified, he has never encountered a case of pulmonary embolism without a predisposing factor. Under all of these circumstances, especially the absence of predisposing factors, Respondent's failure to order a pulmonary arteriogram or obtain a consultation was not a departure from the applicable standard of care, nor was his failure to diagnose a pulmonary embolism, if one in fact existed on May 16. Shortness of breath and rapid heart rate are nonspecific complaints. Respondent retained the patient in the hospital for four hours for observation and analysis of test results. Respondent examined the patient four times during this hospitalization. Respondent reasonably and correctly ruled out a variety of more common diseases and illnesses. Under all of the circumstances, the final diagnosis of tachycardia, which related the shortness of breath to tachycardia or possibly anxiety, was not a departure from the applicable standard of care. Petitioner has therefore failed to prove by clear and convincing evidence that Respondent failed to meet the applicable standard of care in any respect in his diagnosis or treatment of the patient on May 16.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order dismissing the Administrative Complaint. DONE AND ENTERED this 4th day of August, 1998, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 4th day of August, 1998. COPIES FURNISHED: Gabriel Mazzeo, Senior Attorney Carol A. Lanfri, Staff Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 William Partridge Grossman, Roth and Partridge SouthTrust Bank Plaza 1800 Second Street, Suite 777 Sarasota, Florida 34236 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle Southeast Tallahassee, Florida 32399-1703 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle Southeast Tallahassee, Florida 32399-1703 Dr. Marm Harris, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent violated Section 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this proceeding, Dr. Ford was a licensed physician in the State of Florida. His license, numbered ME 0051042, was issued on July 8, 1987. Patient R.A.L, presented to the Emergency Department of Winter Haven Hospital (Hospital) at approximately 1:35 p.m. on October 9, 1997. R.A.L.'s initial chief complaint was right flank pain since 9:00 a.m. that day. He reported a history of vomiting and diarrhea and stated that it felt like a kidney stone, of which R.A.L. had a history. Right flank pain is common with a patient having a kidney stone or kidney problem. R.A.L. was initially examined by Dr. David Siegel about 30 minutes after R.A.L. came to the emergency room. On physical examination palpation, there was no flank pain, but R.A.L. did have moderate pain diffusely throughout all areas of his abdomen. His abdomen was not acutely distended, and there were normal bowel sounds. On Dr. Siegel's order R.A.L. was given Toradol intravenously at 2:22 p.m. to relieve the pain. Toradol is a non-steroidal anti-inflammatory drug. R.A.L. was also given fluids intravenously. R.A.L.'s symptoms did not provide Dr. Siegel with a definitive diagnosis. Dr. Siegel ordered the following tests to be performed: a complete blood count, an amylase, a urinalysis, a PTPDT, and X-rays of the abdomen. The complete blood count was done to make sure that the patient was not anemic and to see if there was an elevated white blood count, which would be indicative of some type of infection or acute abdominal process. The complete blood count showed a significantly elevated white blood cell count of 24.3. The test also revealed that there was a left shift of a differential, which means that there was a high differential percentage-wise of segmented and banded white blood cells. The combination of the significantly elevated white blood cell count and the left shift indicated that there was an acute infectious process or an acute illness. The amalyse test measures a serum enzyme that is secreted from the pancreas. If the serum enzyme is elevated, it could be indicative of pancreatitis. The amalyse test was normal. The urinalysis would show whether there was an infection and would show some abnormalities if there were a kidney stone. R.A.L.'s urine checked out normal. At 3:00 p.m. R.A.L. voided. His urine was strained, but there were no kidney stones present. R.A.L. did not have an adequate response to the Toradol. He was given Demerol intravenously at 3:10 p.m. Based on the test results, Dr. Siegel was unable to make a definitive diagnosis. Because of R.A.L.'s clinical condition and his continued pain, Dr. Siegel ordered an abdominal Computed Tomography (CT) scan to see if he could further define what was going on in R.A.L.'s abdomen. Because of the absence of flank pain, the elevated white blood cell count, and the normal urinalysis report, Dr. Siegel did not rule out the possibility of kidney stones, but did feel that some abdominal process of significance was higher on the list of possible diagnoses than kidney stones. Dr. Siegel went off duty at 5:30 p.m. and turned the care of R.A.L. over to Dr. Ronald Barbour. Dr. Siegel gave Dr. Barbour an oral report of his findings and indicated that he was primarily concerned about a serious intra-abdominal process. Before finishing his shift, Dr. Siegel dictated a written report, which was immediately transcribed and placed in R.A.L.'s chart. Dr. Siegel expected Dr. Barbour to get the results of the CT scan and determine whether the results would allow a diagnosis. When Dr. Barbour came on duty, he went to see R.A.L., who told Dr. Barbour that he was still having some pain. R.A.L. asked for something to relieve the pain, and Dr. Barbour ordered Demerol for him. Dr. Barbour received a call from the radiologist, who said that the CT scan was consistent with a small bowel obstruction. Dr. Barbour told R.A.L. that it appeared he had a bowel obstruction and that he would be admitted to the Hospital. It is the Hospital's policy to contact a patient's primary care physician when a patient is being admitted to the Hospital from the Emergency Department. Dr. Ford was R.A.L.'s primary care physician. Dr. Ford was called by an Emergency Department nurse. Dr. Barbour spoke with Dr. Ford and advised him that the CT scan showed a small bowel obstruction. Dr. Ford stated that he would admit R.A.L. No mention was made of a surgical consult during the conversation. Dr. Barbour did not call a surgeon for a consult because normally if the patient has a primary care physician, the primary care physician would choose the surgeon should a surgical consult be necessary. R.A.L. was admitted to the Hospital at approximately 8:45 p.m. At that point, the responsibility for the care and treatment of the patient shifted from Dr. Barbour to Dr. Ford. Dr. Ford gave admission orders to Lorina Duncan, a nurse in the Emergency Department. The orders included administering Demerol and Phenergan as needed and giving the patient a saline solution intravenously. Dr. Ford also ordered tests to be done the following morning. The nurse's notes do not indicate that Dr. Ford told her to order a surgical consult for the next morning. R.A.L. was given Demerol and Phenergan in the Emergency Department at 9:55 p.m. At 10:10 p.m. R.A.L. was signed out of the Emergency Department to the medical/surgical floor of the Street Building, which is known as Street One. When R.A.L. was admitted to the Hospital, his abdomen was not distended. By the time he was admitted to Street One, his abdomen was distended and firm, and he was complaining of abdominal pain and nausea. When he was placed in his bed, he positioned himself in a fetal position, which is indicative of being in pain. He had no bowel sounds. While the nurse was getting a medical history, R.A.L. was lethargic and would drift off in the middle of the admission questions. His breathing was shallow and rapid. It took the nurse over an hour to complete the admission assessment on R.A.L. after he had come to Street One. At 11:50 p.m., R.A.L. was complaining that his pain had increased throughout his stomach. He indicated that his nausea was better. R.A.L. requested a patient-control anesthetic (PCA), which allows the patient to administer a metered dose of pain medication to himself by pushing a button. Around midnight the nurse had the hospital operator page Dr. Ford. He returned the nurse's call. She told Dr. Ford that R.A.L.'s abdomen was distended and that he was lethargic. R.A.L. had had no pain medication administered since being admitted to Street One, and his next dose of pain medication was to be given at 1:00 a.m. The nurse told Dr. Ford that R.A.L. was complaining of pain and wanted to have a PCA. Dr. Ford gave an order for a Demerol PCA, which would allow a five-milligram dose every five minutes with a maximum of 150 milligrams in four hours. The nurse told Dr. Ford that R.A.L. had been complaining of nausea. Dr. Ford asked whether R.A.L. had vomited, and she advised the doctor that R.A.L. had not. They discussed the possible use of a naso-gastric (NG) tube, which extends from the nose down to the stomach. It is used to aspirate the contents of the stomach, which decreases nausea and distention. Dr. Ford did not order a NG tube. At 12:30 a.m., October 10, 1997, the Demerol PCA was started. At 4:30 a.m., R.A.L. was complaining of shortness of breath. His abdomen was more distended and firm. Dr. Ford was paged, and he gave orders for lab work to be done. At 4:45 a.m. R.A.L. went into distress and died. Dr. Ford arrived at the Hospital about 5:05 a.m. A small bowel obstruction is a condition characterized by the inability of gastrointestinal fluid and material to pass through the small bowel due to some sort of blockage. Symptoms include pain, nausea, vomiting and a change in or cessation of bowel sounds. Small bowel obstructions generally cause the bowels to become inflamed and swollen, which can lead to a cut off of the blood supply to the bowel and result in the rupture of the bowel. If the bowel ruptures, it is a very acute, life-threatening situation which must be treated rapidly. Small bowel obstructions are generally classified as a partial or simple obstruction, and a complete or strangulated obstruction. A strangulated small bowel obstruction means the vascular system has been compromised and the blood supply to a part of the bowel has been cut off. If the blood supply has been cut off, the bowel tissue will become gangrenous, then necrotic, and finally die. Surgery can alleviate the strangulation. Strangulated small bowel obstructions represent 20 to 40 percent of all small bowel obstructions. Post-operative adhesions, bands of scar tissue which form inside the abdomen, are the predominate cause of strangulated bowel obstructions. Severe and constant pain, as opposed to cramping, intermittent pain, can characterize a strangulated small bowel. A strangulated small bowel is a very serious condition. Diagnosis requires obtaining a careful history, recognition of previous operations, a "hands on" physical examination and diagnostic testing. With a small bowel obstruction, a patient’s condition can change rapidly, sometimes in a matter of hours. Because any change in the condition of the patient can indicate a significant problem, serial abdominal examinations are important. Early detection and evaluation of complications from small bowel obstructions are also important. In the case of R.A.L., the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances would have been for Dr. Ford to come to the Hospital and physically examine R.A.L. when the patient was admitted to the Hospital under his care and after Dr. Ford was called by the nurse around midnight, apprising him of R.A.L.’s condition. Dr. Ford did not come to the Hospital to examine from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died. A strangulated bowel is a surgical emergency. If a physician fails to diagnose and treat a strangulated small bowel, the patient will likely die. The physician will normally consult a surgeon when the patient presents with a small bowel obstruction. In performing a surgical consult, the surgeon will make the determination of whether and when to perform surgery. The sooner the surgeon is involved, the less the chances of compromising the patient’s bowel or general physical condition. Calling a surgeon early in the course of treating a patient with a small bowel obstruction is the prudent thing to do. In the case of R.A.L., the level of care, skill, and treatment, which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, would have been for Dr. Ford to call for a surgical consult when R.A.L. was admitted to the Hospital under his care. Dr. Ford did not call for a surgical consult from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Ronald A. Ford, M.D. violated Section 458.331(1)(t), Florida Statutes, placing him on two years' probation, imposing an administrative fine of $5,000, and requiring him to take five hours of continuing medical education in the area of risk management and 16 hours of continuing medical education in the area of diagnosing and treating abdominal and gastrointestinal disorders. DONE AND ENTERED this 5th day of February, 2002, in Tallahassee, Leon County, Florida. ___________________________________ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of February, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 William B. Taylor, IV, Esquire McFarland, Ferguson & McMullen 400 North Tampa Street Suite 2300 Tampa, Florida 33620 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact The Respondent is a licensed medical doctor holding license number 0013446 issued by the Florida Board of Medical Examiners. He specializes in internal medicine, geriatrics, endocrinology and nuclear medicine with an extensive educational and professional background in those fields. He is currently in private practice in Dade County, Florida. The Petitioner is an agency of the State of Florida charged by Chapter 458, Florida Statutes (1981), with administering, regulating, and enforcing the licensure and medical practice standards as delineated by that chapter and related rules. Maurice Blanchar was examined at the Miami Heart Institute in 1976. At that time it was suggested by his attending physician that Mr. Blanchar have a "nuclear scan" because of a suspected abnormality described as "Gallin Syndrome." Mr. Blanchar was also examined at the Cooper Clinic in Dallas, Texas, in 1979, at which time it was also suggested that he have a nuclear scan (apparently related to cardiac complaints at that time of an unspecified nature). A coronary angiogram was performed at the Cooper Clinic, which was within normal limits. Sometime in 1979, Mr. Blanchar, with a prior history of undiagnosed cardiac complaints, read an advertisement in a local newspaper which offered nuclear scans to be performed by the Respondent, Dr. Sternberg. Mr. Blanchar kept this advertisement in his possession for approximately one year and ultimately called the Respondent's office for an appointment in July of 1980. Upon obtaining his appointment, Mr. Blanchar was advised to bring $95 as a initial fee, together with proof of medical insurance coverage. Upon arriving for his scheduled appointment at the Respondent's office, Mr. Blanchar executed a questionnaire designed to disclose his medical history. His specific presenting complaint was that he was suffering chest pains. He was a regular "jogger" and had no pain or discomfort attendant to this exercise, but suffered chest pains only while resting in bed at night. He met with the Respondent and informed the Respondent that he was responding to the advertisement regarding "nuclear scans" and informed the Respondent of his complaint, a somewhat unusual occurrence. Based upon Mr. Blanchar's complaints, together with information discerned from Mr. Blanchar's previous records from the Cooper Clinic and the Miami Heart Institute, Dr. Sternberg discussed the procedures he intended to perform with Mr. Blanchar. Dr. Sternberg informed him of the tests he would perform before and as he was performing them. Dr. Sternberg explained, and Mr. Blanchar admitted in his testimony, that the $95 fee was not for the entire nuclear scan series of tests performed, but was rather for a consultation and initial examination performed by the Respondent. The record does not clearly reflect whether specific fees for tests or procedures to be performed were discussed between the Respondent and Mr. Blanchar at this time, other than the Respondent informing Mr. Blanchar that his insurance company would pay for the cost of the nuclear scans involved. Prior to beginning the testing, the Respondent had no presupposition that Mr. Blanchar had cardiac arterial disease, based upon a previous normal coronary angiogram, and the symptoms of lack of pain while jogging, but pain while at rest in bed at night. Dr. Sternberg was aware that Mr. Blanchar was a jogger, which indicated to the Respondent that in terms of likelihood, his chances of having coronary artery disease were extremely small in terms of percentages. However, the fact that he developed chest pains while at rest in bed, led Dr. Sternberg to believe that this symptom could possibly be related to coronary artery disease. Because of the possibility of a hiatal hernia, arthritis, or possibly a congenital heart lesion, the Respondent performed three tests, the so-called "first pass," "MUGA at rest" and "MUGA at stress." All tests were designed to give complementary information, which information is not necessarily achievable by any one procedure in and of itself. The first procedure performed was the cardiac imaging blood pool test, commonly referred to as a "first pass study." It is the function of this test to assess the pattern of blood flow through the heart to determine right and left ventricular performance which is measured by cardiac wall motion and "ejection fraction." The first pass test is also utilized if there is a suspicion of vascular misformation, obstruction or shunting in a patient's heart. The first pass test was found to yield results within normal limits. The next procedure performed by the Respondent was the cardiac imaging, gated, static test, designed to show cardiac wall motion and ejection fraction, which last term is related to the volume of blood pumped by the heart upon ventricular contraction. This procedure is commonly termed the "MUGA at rest" study. The main concern of this test is a measurement of cardiac function as observed by wall motion of the heart and measured by the ejection fraction while the patient is at rest. This procedure is most commonly done as a baseline study for obtaining information concerning cardiac function while the patient is at rest for purposes of comparison with the cardiac imaging, gated, wall motion, ejection fraction test done with the patient at stress. This latter test is referred to as "MUGA at stress" and is performed in the case of patient Blanchar by using the so-called "Cold Presser Method," which involves stressing the heart to the required degree for the test by fastening an ice bag on the arm of the patient until he has reached the level of stress desirable for performing the MUGA at stress test. The MUGA at stress performed by the Cold Presser Method, although somewhat experimental, is an accepted means of inducing cardiac stress in the patient for purposes of obtaining meaningful MUGA at stress results. The MUGA at stress test, when used in conjunction with the MUGA at rest study, gives the physician a comparison of relevant data concerning cardiac function. Dr. Sternberg was the primary treating physician for Mr. Blanchar. He did not see him on a referral basis from any other physician with any attendant request to do a specific or narrow diagnostic service. Rather, Mr. Blanchar presented himself with a complaint of chest pains at night while at rest, therefore Dr. Sternberg had a broader range of potential problems to consider in determining which diagnostic test to perform on Mr. Blanchar. When Dr. Sternberg performed the first pass test, which was performed first of the three tests performed on patient Blanchar, the ejection fraction was normal, but on the lower side of a normal range for this patient. Dr. Sternberg and the Respondent's expert witness, Dr. Epstein, as well as Dr. Gottlieb testifying for the Petitioner, established that the first pass test is medically indicated to rule out problems such as "shunting," obstructions or regurgitation. Dr. Sternberg had no prior medical history of Mr. Blanchar which would automatically rule out any such problems and, in the exercise of sound medical judgment, felt that the first pass test should he performed. The decision to perform this test was medically appropriate given the patient's symptoms and the doctor's responsibility as the only primary care physician involved. Dr. Sternberg then performed the MUGA studies at rest and at stress and found that the wall motion of the heart looked normal in the left anterior oblique view. The ejection fraction was normal with the MUGA study "at rest" test, but was higher in the normal range than had been the case with the first pass study, which led him to believe that the previous first pass study had an anxiety factor in the patient as a contributing factor to its results. Thus, the MUGA at stress test was able to confirm the efficacy of the performance of and results of the first pass study and Dr. Sternberg was, as well, able to rule out any problems related to shunting, regurgitation, or obstruction in the patient. He was able to confirm that the first pass study, with the patient's anxiety as a factor, had resulted in a slightly altered ejection fraction result. In any event, after these two tests were performed, he also felt the need to look at the wall motion of the heart, under stress conditions in the other areas of the heart, because he had not yet found any area of abnormality. Ultimately, no substantial abnormality was found in the patient's heart, except a suggestion that stress altered his ejection fraction. He also found that the wall motion of Mr. Blanchar's heart in the region of the left circumflex branch, the posterior laterial wall, towards the apex, showed sluggish motion, in fact, almost a paradoxical type of motion during stress, as compared with the baseline study which indicated that there was evidence of probable coronary artery disease at that point. Dr. David Allen Epstein practices diagnostic radiology and nuclear medicine. He was accepted as an expert witness on behalf of the Respondent and largely corroborated the Respondent's testimony, finding the procedures performed by Dr. Sternberg for patient Blanchar to be medically legitimate and to constitute matters of clinical judgment. Dr. Epstein established that the Respondent had available to him other justifiable tests beyond those he performed for Mr. Blanchar and established that the first pass, MUGA at rest and MUGA at stress studies performed, were for medically justifiable reasons and, in a patient with the presenting symptoms of Mr. Blanchar, were each designed to elicit information not directly available from the other tests. The use of color for cardiac computer studies is a useful diagnostic procedure. Neither Dr. Stuart Gottlieb nor Dr. Stolzenberg (Petitioner's expert witnesses) found any fault with the management or care provided these patients, nor the choice of tests performed by Dr. Sternberg with the exception of the first pass test and the separately billed stress test. Both Drs. Gottlieb and Stolzenberg felt the first pass test was redundant. However, their testimony in this regard is rejected and Dr. Epstein's and the Respondent's is accepted, inasmuch as the Respondent was the primary care physician and the only physician concerned with these proceedings who saw the patients in a clinical setting, charged with evaluating the patient's own complaints and arriving at a diagnosis. Patient Blanchar was not presented to the Respondent by another referring physician upon a narrow area of specific inquiry, rather Dr. Sternberg had to perform the added first pass study in order to rule out possible shunting, obstruction, regurgitation and other problems and his testimony regarding the necessity for this is corroborated by that of his expert, Dr. Epstein. It was established that all three cardiac studies were efficacious with regard to patient Blanchar and the Respondent's testimony and Dr. Epstein's testimony is accepted to the exclusion of other testimony in this regard. The Respondent's bill presented to patient Blanchar (and presumably his insurance carrier) is set forth in Petitioner's Exhibit "A" and reflects the following charges: Comprehensive office visit, new patient $ 95.00 Stress testing 150.00 Provision of Radionuclide 20.00 Cardiac Imaging gated (wall Motion, ejection fraction) w/stress 500.00 Cardiac Imaging gated (wall Motion, ejection fraction) static 500.00 Cardiac Imaging blood pool (1st pass) and or vascular flow 500.00 Dr. Sternberg charged patient Blanchar an additional $150 for "stress testing" which is represented on his bill to be a separate and different test from the cardiac imaging, gated, wall motion study with stress or "MUGA at stress," for which the doctor charged Blanchar $500. Although the Respondent represented that this "stress testing" was a separate service performed, there is no evidence whatever in the record which would establish that such a stress test was performed separate and apart from the MUGA at stress, performed for the $500 charge. A separate stress test would have been redundant and unnecessary in any event. It is obvious therefore that the patient Blanchar was billed for a separate item called "stress testing" in the amount of $150 which was not actually performed and which was not necessary. Dehlia Teramo suffered an automobile accident on March 12, 1980. She was initially seen by Dr. Carlos B. Fernandez, who saw her on the day of the accident. He ultimately referred Ms. Teramo to the Respondent with a history of trauma sustained in the accident with subsequent pain throughout her head, ears, eyes, neck, nose, and left shoulder. On April 10, 1980, Ms. Teramo initially saw the Respondent complaining of frequent headaches, neck pain, eye pain, high blood pressure, back and shoulder pains and pain in her nose, having sustained trauma and unconsciousness after being thrown about in the interior of her car during the auto accident. She additionally suffered pain in the left upper and lower parts of her mouth and suffered a recurrence of her menstrual period. Dr. Fernandez sent her to the Respondent for evaluation and diagnosis with reference to all these physical complaints, including the possibility of a fracture in the head or left shoulder area, but not solely for determination of the presence of a fracture of the sphenoid bone of the head. The Respondent performed three diagnostic tests or studies on different dates to attempt to determine the basis of Ms. Teramo's injuries. The first study was conducted on April 10, a blood circulation study. This study, when confined to the cerebral area is known also as a brain flow study. The study was conducted by the Respondent in area of the head as well as the spine and shoulder. The test is performed by injecting the patient with a radionuclide and then following the "bolus" throughout the areas in the which the physician is interested in gathering data with an x-ray camera assisted by a computer. In effect, this test images the blood flow in the blood vessels involved in the head, spine and shoulder areas and is used to detect subdural or epidural hematomas, abnormal vascular changes in the brain and in the other areas tested. It is designed to show any breaks or "leaks" in the blood/brain barrier, that is, any passage of blood from the vascular system of the brain into surrounding brain tissue. In itself, it is not the primary test for determining a fracture, but it is useful and all expert witnesses agreed and established that it was within sound medical judgment and patient management to perform such a test to aid and ascertain the basis for the complaints Ms. Teramo had regarding her head, neck and shoulder areas. A sphenoid bone fracture would be difficult to diagnose with this one test alone, but that was not the sole basis for the referral of Ms. Teramo to the Respondent. The radionuclide which is injected travels throughout the patient's body and the physician can do a number of limited scans or a total body scan utilizing the one injection of radionuclide. In performing the blood circulation or blood flow study, the Respondent charged patient Teramo for each component of the study, in effect, each view taken was charged for as a separate procedure as was the injection of the radionuclide. The computer processing and color image analysis was also disclosed to patient Teramo to be a separate procedure and was billed for separately, as shown on Petitioner's Exhibit "K," the bill set forth below. The blood circulation study and the quantitative cerebral blood flow study were represented to the patient Teramo on the bill as being separate studies and a separate $200 charge was assessed against the patient for the quantitative cerebral flow study. These studies are performed during the same patient visit and utilizing the same injection of radionuclide. The cerebral blood flow study is dynamic, with imaging done as the radioactive "bolus" moves through the vascular area in question. The blood circulation study, also called blood pool study, is the static form phase of the procedure performed after the vascular system in the area in question has already been completely infused with radionuclide. The testimony of Dr. Stolzenberg, coupled with that of the Respondent himself, establishes that the quantitative cerebral blood flow study is indeed tested with the same injection of radionuclide at the same patient visit. It is a different test or procedure, however, although many practitioners do not use it and it is unusual to see it used. However, it was not demonstrated, because it is not a standard type of procedure, that a practitioner should not charge a separate fee for it, not that the brain flow study always necessarily includes a quantitative, cerebral blood flow study. Thus it was not shown that the quantitative, cerebral blood flow study with the separate charge of $200 on Ms. Teramo's bill was not a separately identifiable test performed on her. The Petitioner also was unable to establish that this particular test was not medically indicated for a patient with Ms. Teramo's presenting symptoms. On April 14, 1980, the Respondent performed another nuclear scan on patient Teramo, known as a bone scan. This is accomplished by again injecting the patient with a radionuclide substance which adheres to the bones and joints after passage of a period of time while the patient waits in the examining facility. This scan was utilized for the same areas as the previous scan or blood flow study, that is the head and left shoulder areas and cervical spine area. The bone scan is used to aid in the physician's determination of the presence of fractures. The Respondent separated his charges for this procedure into a separate charge for each view obtained, as well as a separate charge for the injection of the radionuclide, and a separate charge for computer processing and clinical color imaging analysis done by the Respondent himself. On April 18, 1980, the Respondent performed an echoencephalogram upon patient Teramo. This procedure is designed to determine the presence of subdural or epidural hematomas, fractures and tumors. It is commonly utilized in cases of patients who sustain traumatic injury. Having reviewed the results of all these procedures, the Respondent arrived at a diagnosis of patient Teramo as having a fracture of the sphenoid bone of the head. No apparent diagnosis was made with reference to the shoulder area. The Respondent presented a bill to patient Teramo, admitted as Petitioner's Exhibit "K," reflecting the following pertinent charges: 4/10/80 Initial consultation $ 95.00 Injection of Radio- nuclide for scans 20.00 Scans: (Blood circulation study) Head LL 75.00 Head PA 75.00 Head Vertex 75.00 Cervical Spine PA 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head AP 75.00 Head RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis 350.00 Quantitative Cerebral Blood Flow Study 200.00 4/14/80 Office visit 25.00 Injection of Radio- nuclide for scans 20.00 Scans: (Bone and Joint Study) Head AP 75.00 Head RL 75.00 Head LL 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head PA 75.00 Cervical Spine PA 75.00 Cervical Spine LL 75.00 Cervical Spine RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis. 350.00 4/18/80 Office visit 25.00 Echoencephalogram, A-Mode 150.00 The blood and bone scan studies done with regard to Ms. Teramo's complaints, as well as the echoencephalogram, are medically appropriate and a proper exercise of sound medical judgment by a clinical physician and primary treating physician in the position of Dr. Sternberg with regard to this patient. It must be remembered that Ms. Teramo was not merely presented for determining the presence of a sphenoid fracture, rather she was presented to Dr. Sternberg by Dr. Fernandez, for investigation of various types of suspected pathologies. Dr. Sternberg's testimony, as corroborated by that of Dr. Epstein, establishes that certain fractures not always detectable by specific types of radiographic techniques may be detected by the device of blood pool scans. The Respondent showed (corroborated to some extent by Drs. Gottlieb and Stolzenberg) that the tests performed on Ms. Teramo constituted matters of clinical judgment and that Dr. Sternberg had available to him other tests which he could have performed on Ms. Teramo or Mr. Blanchar and did not. Some physicians use color imaging in computer processing and that is a legitimate type of evaluation and diagnostic technique. Further, Dr. Stolzenberg recognizes that there are some physicians who do cerebral blood flow studies of the brain and charge fees there for and acknowledges that there is no prohibition against such a procedure and that some physicians use the aid of a computer during performance and evaluation of brain scans as a routine matter. Neither of the Petitioner's expert witnesses are primary care physicians and Dr. Stolzenberg admitted that he does not practice internal medicine; neither have examined either of Dr. Sternberg's patients concerned in this proceeding. Only Dr. Sternberg, of the three doctors involved, is a primary care physician. It has thus been shown that the first pass study, the MUGA at rest and the MUGA at stress studies, as well as the blood circulation study, quantitative cerebral blood flow study and bone scans performed on these two patients were medically legitimate and all were within an appropriate choice of tests and were selected and performed in a manner within acceptable medical standards. The fact that the Respondent charged a $75 fee for each of the various scans or views of the head, shoulders, and cervical spine of Ms. Teramo for purposes of the blood circulation study and the bone scans performed appears exorbitant, however there is no evidence that it was not a charge directly related to the Respondent's time and skill as a highly trained specialist, coupled with a component in each of those charges for the use of highly sophisticated, color, computer processing equipment and camera which he owned and operated himself in his own office. Since the specific rates charged by physicians for this and any other type of service, are not regulated, these charges cannot be delved into further for purposes of this proceeding once the diagnostic procedures to which they relate have been established, to be medically acceptable, which they have, with the exception of the $150 charged patient Blanchar for the unperformed stress test.
Recommendation Having considered the foregoing Finding of Fact, Conclusions of Law, the candor and demeanor of the witnesses and the pleading and arguments of the parties, it is, therefore RECOMMENDED: That the Board of Medical Examiners enter a Final Order finding the Respondent, Joshua L. Sternberg, M.D., guilty of a violation of Sections 458.331 (1)(1) and (o) Florida Statutes (1981), to the extent delineated above, and that he be fined the sum of $1,000 for each of the above two violations. DONE and ENTERED this 30th day of November, 1983, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 30th day of November, 1983. COPIES FURNISHED: Harold M. Braxton, Esquire 45 S.W. 36th Court Miami, Florida 33135 Steven M. Slepin, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated August 30, 2000, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43 and Chapters 455 and 458, Florida Statutes (1997). Dr. O'Rourke is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 0044786. He has been in private practice in Fort Lauderdale, Florida, since 1985 and was board-certified by the American Board of Surgery in 1987 and re-certified in 1997. Dr. O'Rourke has been the Chief of Surgery at Broward General Medical Center since 1997. In early 1996, R.F., a 65-year-old woman, was referred to Dr. O'Rourke by Dr. Rajendra P. Gupta, a physician who had treated R.F. at the Broward General Medical Center Clinic ("Clinic") in 1995 and early 1996. The purpose of the referral was for a surgical consultation regarding a mass on R.F.'s liver. 1/ Dr. O'Rourke first saw R.F. at the Clinic on February 14, 1996, and on February 21, 1996, R.F. returned to see Dr. O'Rourke for preoperative testing. Dr. O'Rourke examined R.F., took a patient history, and ordered several preoperative tests. Dr. O'Rourke also reviewed R.F.'s medical records from the Clinic and her hospital chart from Broward General Medical Center ("Broward General"). These documents included, among other things, the record of prior consultations with physicians at Broward General, the films from a recent M.R.I. and a recent CT scan, and the results of a CT-guided biopsy, x-rays, sonograms, blood tests, and an esophageal endoscopy. The CT-guided biopsy did not confirm or rule out the possibility that the mass on R.F.'s liver was cancerous. However, because tests showed that R.F.'s alpha-fetoprotein levels 2/ were abnormal, Dr. O'Rourke considered the mass to be a cancerous tumor and, therefore, lethal. Based on the results of the tests ordered by Dr. Gupta and by Dr. O'Rourke and on the information in R.F.'s medical records and hospital chart, Dr. O'Rourke decided that it would be appropriate to perform an exploratory laparotomy on R.F. to evaluate the mass and, if indicated, perform a right hepatic segmentectomy, or resection, to remove the mass. Dr. O'Rourke explained the gravity of the situation to R.F. and told her that he wanted to perform exploratory surgery to determine if the mass on the liver could be removed and to remove it, if possible. R.F. discussed the proposed surgery with her family and notified Dr. O'Rourke that she would have the surgery. In deciding that an exploratory laparotomy was appropriate for R.F., Dr. O'Rourke considered and evaluated the risk that R.F. would have excessive bleeding during the procedure. The presence of significant cirrhosis of the liver is one indication that a patient might bleed excessively during a hepatic resection. 3/ The results of the esophageal endoscopy performed on R.F. in October 1995 did not show the presence of esophageal varices, nor did the results of R.F.'s CT scan show the presence of ascites. Both of these conditions are indicative of portal hypertension, which is increased blood pressure in the portal triad that provides blood to the liver. 4/ Portal hypertension is caused by a slowing of the blood flow through the liver, which is, in turn, caused by cirrhosis of the liver. Because there was no evidence of portal hypertension in R.F.'s test results, there was no conclusive preoperative evidence that R.F.'s liver was cirrhotic. 5/ Nonetheless, based on other indications in R.F.'s medical records and test results, Dr. O'Rourke considered it highly probable that R.F.'s liver was cirrhotic. R.F. was at high risk of cirrhosis because she had a positive hepatitis profile for Hepatitis B and C, because she had a probable primary cellular carcinoma in the liver, and because her outpatient medical records revealed a persistent elevation of cellular enzymes in her liver. However, the extent of R.F.'s cirrhosis could not be precisely determined through preoperative testing; it could only be conclusively determined intraoperatively. The more important consideration in Dr. O'Rourke's evaluation of R.F. as a candidate for an exploratory laparotomy and possible hepatic resection was the functional ability of R.F.'s liver. There was no preoperative evidence that R.F.'s liver function was abnormal; her PT levels and her bilirubin levels, both important indicators of liver function, consistently tested within the normal range. Dr. O'Rourke also considered the possibility that R.F.'s tumor was particularly vascular, 6/ which would also indicate that R.F. would bleed excessively during surgery. It is not possible to determine conclusively before surgery if a tumor is vascular; that determination can only be made once the tumor is visible and can be manipulated. However, there was no preoperative evidence that R.F.'s tumor was particularly vascular. R.F. tolerated a CT-guided biopsy of the liver prior to surgery; there was nothing in the biopsied tissue that indicated the tumor was particularly vascular, nor was there any significant bleeding as a result of the biopsy. This would indicate that R.F.'s tumor was not particularly vascular. Dr. O'Rourke did not request a preoperative cardiology consultation for R.F. because there were no indications of a cardiac risk in her medical records or in her test results. Although R.F. had diagnoses of systemic hypertension and of atrial fibrillation, both of which are very common, the hypertension was controlled by Accupril and a diuretic, and neither the hypertension nor the atrial fibrillation would indicate the need for a cardiology consultation. R.F.'s EKG was interpreted as borderline; and there were no indications in her medical records that R.F. had ischemic heart disease. In addition, the anesthesiologist who was to administer anesthesia to R.F. during the surgery did not request a cardiology consultation. 7/ Had the anesthesiologist been concerned about R.F.'s cardiac fitness to tolerate general anesthesia, he or she would likely have cancelled or deferred the surgery. The only documentation of the location of the hepatic mass that Dr. O'Rourke included in R.F.'s medical records was a notation that the indicated procedure was a right hepatic segmentectomy. However, even though Dr. O'Rourke did not more precisely set forth the location of the mass in the documentation, he knew the exact location of the mass from having examined the film of the CT scan and of the M.R.I. performed on January 3, 1996, which showed an "ovoid solitary mass along the dome of the right lobe of the liver." In addition, the report of the sonogram performed on November 21, 1995, which was available to and reviewed by Dr. O'Rourke, showed a "focal mass on the diaphragmatic surface of the right lobe of the liver." On February 27, 1996, Dr. O'Rourke performed exploratory surgery on R.F. to determine the resectability of the liver tumor. Ultimately, Dr. O'Rourke performed a non- anatomic hepatic resection to remove the tumor. Dr. O'Rourke prepared adequately for the possibility that R.F. would experience blood loss during the exploratory laparotomy. As noted above, however, there were no preoperative indicators that R.F. would experience excessive blood loss. Dr. O'Rourke requested that a cell saver be available in the operating room during R.F.'s surgery, 8/ and the anesthesiologist ordered R.F.'s blood to be typed and screened to identify the correct blood type. Dr. O'Rourke did not order R.F.'s blood to be typed and cross-matched, which provides the most specific information about the particular type of blood required by the patient. Although the better practice is to have the patient's blood typed and cross-matched prior to surgery, it takes only ten minutes to obtain typed and cross- matched blood from the blood bank should the patient lose more blood than can be replaced by the cell saver. 9/ R.F.'s blood pressure was monitored during the surgery by an arterial line, and good access was provided for the introduction of fluids into R.F. through two intravenous lines placed by the anesthesiologist, one 16-gauge line and one 18-gauge line. Dr. O'Rourke did not place a "central line," or central venous pressure ("CVP") line, 10/ into R.F. preoperatively. The anesthesiologist usually makes the decision to insert a CVP line preoperatively, and, in R.F.'s case, Dr. O'Rourke agreed with the anesthesiologist that it was not necessary. Some surgeons routinely insert CVP lines preoperatively when performing an exploratory procedure such as Dr. O'Rourke was performing on R.F.; other surgeons prefer to wait until they are sure that they will perform the hepatic resection because there are a multitude of risks attendant to the insertion of a CVP line, a bleeding pneumothorax being the most common. 11/ Dr. O'Rourke began the exploratory laparotomy by opening R.F.'s belly and removing scar tissue that resulted from prior surgery. He dissected into the abdomen, down to the fascia, and again removed scar tissue that resulted from prior surgery. He divided the falciform ligament and removed it at the point where it attaches to the liver, a procedure that is necessary before the liver can be mobilized. Dr. O'Rourke moved the falciform ligament further up to its diaphragmatic attachment so that he could have full access to the dome of the liver, where R.F.'s tumor was located. Once the falciform ligament was separated from the liver, Dr. O'Rourke palpated the tumor and determined that it was very fragile and tended to crumble. Dr. O'Rourke then mobilized R.F.'s liver. 12/ When he did so, the tumor ruptured, and R.F. started to bleed from the posterior of the liver. R.F.'s blood pressure fell dramatically, a condition known as hypotension, and she became unstable. Dr. O'Rourke's first priority was to stop the bleeding and stabilize R.F.'s blood pressure, and he decided to pack the liver, the most extreme technique used to stop bleeding in or around the liver. Unfortunately, once a patient undergoing hepatic surgery begins to bleed, it is very difficult to stop the bleeding. 13/ The Pringle maneuver is one technique that can be used to control bleeding in and around the liver. This technique requires dissecting around the portal triad and clamping the hepatic artery and the portal vein in order to stop temporarily the blood flow from the portal triad into the liver. Dr. O'Rourke's decision to pack R.F.'s liver rather than attempt the Pringle maneuver was based on several factors. First, R.F. had a significant amount of scar tissue on her anterior abdominal wall, and Dr. O'Rourke anticipated that, given her rapidly deteriorating condition, it would take too much time to dissect through the scar tissue to expose the portal triad. Second, the Pringle maneuver provides only a temporary solution because the portal triad can be clamped and the blood flow into the liver stopped for no more than 15 minutes at a time; the maneuver can be repeated if necessary when working with a healthy liver but it is very risky to do so when working with a cirrhotic liver such as R.F.'s. Third, although it can be helpful to a surgeon trying to find the source of bleeding to temporarily stop the blood flow from the portal triad, Dr. O'Rourke already knew that the bleeding originated in the posterior of the liver, behind the tumor. At the same time that Dr. O'Rourke was packing the liver, the anesthesiologist was resuscitating R.F. with fluids and calling the blood bank to order cross-matched blood. After packing the liver, Dr. O'Rourke observed the site of the bleeding for 15 to 20 minutes, during which time the bleeding decreased slightly but not significantly. R.F.'s parameters did not improve, and Dr. O'Rourke decided to close the abdomen. After closing the abdomen, Dr. O'Rourke inserted a CVP line; the CVP line was inserted primarily for the purpose of more quickly introducing fluids and blood products into R.F. Once he had placed the CVP line, Dr. O'Rourke assisted the anesthesiologist in attempting to resuscitate R.F. by the rapid infusion of fluid and blood. At this point, Dr. O'Rourke anticipated that R.F. would stabilize, and, once she had stabilized, Dr. O'Rourke intended to wait 24-to-48 hours, reopen the abdomen, remove or replace the lap packing, and close the abdomen without removing the tumor. He decided that, when he re-opened the abdomen, it would be too risky to proceed with the tumor resection because of the likelihood that R.F. would again begin bleeding. Dr. O'Rourke's plans changed because R.F.'s blood pressure did not significantly improve after approximately 20 minutes, and the degree of her hypotension was out of proportion to her actual blood loss, which Dr. O'Rourke estimated as 300- to-400 cubic centimeters. Under these circumstances, Dr. O'Rourke felt that he had two alternatives: to do nothing and let R.F. die or to re-explore the liver. He, therefore, re- opened the incision, removed the packing, and confirmed that the packing had not controlled the bleeding. When packing fails to control the bleeding, the surgeon has a serious problem and a limited number of options: The surgeon can temporarily stop the flow of blood into the liver by using the Pringle maneuver; the surgeon can extend the incisions under the ribs or into the side and fully mobilize the liver 14/ to expose its posterior and possibly locate the source of the bleeding; or, the surgeon can remove the tumor to try to gain access to the vessels that are bleeding so that they can be suture-ligated. Dr. O'Rourke had already rejected the Pringle maneuver as too time-consuming and unlikely to be successful in stopping the bleeding. He decided not to fully mobilize the liver because R.F.'s liver was cirrhotic, and therefore somewhat brittle, so that, had he attempted to mobilize the liver fully, he risked exacerbating the bleeding. In any event, the tumor was completely accessible to Dr. O'Rourke without fully mobilizing the liver. Dr. O'Rourke decided that, under the circumstances, the best chance of saving R.F. was to remove the tumor, thereby gaining access to the posterior of the liver and to the hepatic veins, which he suspected were the source of the bleeding. Once the tumor was removed, he could suture-ligate the blood vessels from which the bleeding originated. Accordingly, Dr. O'Rourke performed a non-anatomic hepatic resection. He found that the tumor resection itself was easy and presented no problems. He individually suture-ligated the vessels that provided the tumor's blood supply and brought the bleeding down to a low level. Dr. O'Rourke felt that he had controlled the bleeding, and R.F.'s hepatocrit level was brought back to a low-normal, but acceptable, level. Nonetheless, R.F.'s blood pressure did not improve and actually deteriorated. Despite the successful efforts to control the bleeding and the efforts to resuscitate R.F. by transfusing blood and fluids, her condition continued to deteriorate, and she was pronounced dead at 6:23 p.m. on February 27, 1996. Dr. O'Rourke spoke with R.F.'s family and told the family members that the amount of R.F.'s blood loss did not explain why her blood pressure fell so low or why her condition continued to deteriorate in spite of his having controlled the bleeding and in spite of the efforts to resuscitate her with blood and fluids. He asked the family for permission to do an autopsy to determine what had happened. The family refused, although they later had a private autopsy done at Jackson Memorial Hospital in Miami, Florida. The cause of death stated in the autopsy report was "[e]xsanguination post subtotal hepatic resection." The evidence submitted by the Department is not sufficient to establish with the requisite degree of certainty that Dr. O'Rourke failed to keep adequate medical records to justify the course of his treatment of R.F. Because R.F. was a Clinic patient, Dr. O'Rourke had access to the medical records kept since her first consultation with Dr. Gupta in October 1995, as well as access to all of the results of the tests performed on her from October 1995 through the date of surgery. In the record of his examination of R.F., Dr. O'Rourke included her surgical history, her medical history, a list of the medications R.F. was taking, and the results of his physical examination of R.F. His proposed treatment of R.F. was identified in the documentation as a right hepatic resection. Taken altogether, the documentation in this case adequately justifies Dr. O'Rourke's decision to do an exploratory laparotomy and a right hepatic resection, if indicated, and there is no evidence that additional documentation was required. 15/ The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. O'Rourke's preoperative examinations, testing, or planning fell below that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. R.F.'s medical records and chart establish that she was given a battery of pre-operative tests, and the Department's expert witness could not identify any additional pre-operative test that should have been given. Dr. O'Rourke examined the patient and noted the results of his examination, as well as the medications she was taking, on the Outpatient/Short Stay Record. Dr. O'Rourke knew the exact location of the mass on R.F.'s liver, he adequately noted the location of the tumor as the right posterior lobe of the liver, and he knew that, although R.F.'s liver was most likely cirrhotic, her liver function was normal, albeit low normal. A pre-operative cardiology consult was not indicated by R.F.'s medical records or test results. It is uncontroverted that Dr. O'Rourke's decision to do an exploratory laparotomy on R.F. was not inappropriate. Dr. O'Rourke anticipated that R.F. would suffer blood loss during the surgery, and he planned for the anticipated blood loss by ordering a cell saver for the operating room. Although Dr. O'Rourke perhaps should have had R.F.'s blood typed and cross-matched prior to the surgery, his failure to do so did not appreciably delay the delivery of additional blood to R.F. The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. O'Rourke's intraoperative efforts to control R.F.'s bleeding fell below that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Dr. O'Rourke's decisions to pack the liver to control the bleeding and then, when that failed, to remove the tumor in an effort to expose the vessels that were bleeding were not inappropriate under the circumstances. Although there were options other than packing available to help control the bleeding, Dr. O'Rourke rejected these options as too time- consuming, as temporary solutions, as unnecessary, or as unlikely to be successful. Dr. O'Rourke's decision to remove the tumor to gain access to the vessels that were the source of the bleeding and to attempt to stop the bleeding by suture- ligating these vessels was a decision that could only have been made intraoperatively, based on all of the information available to Dr. O'Rourke at the time. Although R.F. was very unstable, the cell-saver was recycling the blood she was losing and re- infusing it, and R.F. was receiving other blood products and fluids. Given the available options, Dr. O'Rourke's decision was not inappropriate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Aiden Matthew O'Rourke, M.D. DONE AND ENTERED this 26th day of January, 2001, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO 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 26th day of January, 2001.
The Issue Whether the Respondent committed the violations set forth in the Administrative Complaint dated November 2, 1998, and, if so, the penalty which should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Sections 20.43 and Chapters 455 and 458, Florida Statutes (1997). Dr. Carida is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 0019622. Dr. Carida is board-certified in cardiology and internal medicine and has practiced non-invasive cardiology since 1973. Dr. Carida has not attended patients in the hospital since 1989 because of his own health problems. It is, and has been, Dr. Carida's practice to place his hospitalized patients under the care of another cardiologist or a physician practicing in the appropriate specialty. In April 1994, R.M. was a 72-year-old man who had a medical history significant for insulin-dependent diabetes mellitus, alcohol abuse, chronic obstructive pulmonary disease, peptic ulcerative disease, obesity, prostate cancer, and clinically insignificant coronary artery disease. He had been Dr. Carida's patient since approximately 1986. J.M., R.M.'s wife, called Dr. Carida on March 19, 1994, and reported that R.M. was bleeding. Dr. Carida told J.M. to take her husband to North Broward Medical Center. Dr. Carida saw R.M. in the emergency room and explained to J.M. and R.M. that he would not be attending R.M. in the hospital. Dr. Carida advised them that Dr. Stephen G. Sackel, a gastroenterologist, would be caring for R.M. during his hospital stay. R.M. was admitted to the North Broward Medical Center by Dr. Sackel on March 19, 1994, with the diagnoses of insulin- dependent diabetes out-of-control, GI (gastrointestinal) bleeding and anemia, coronary artery disease with chest pain, and obesity. Based on R.M.'s medical history and physical examination in the emergency room, Dr. Sackel called in Dr. Salvatore DiGiorgi, a cardiologist, for a consultation. R.M. was discharged from the North Broward Medical Center on March 29, 1994, by Dr. Sackel with a discharge diagnosis of anemia secondary to gastrointestinal bleeding, chest pain, emphysema, diabetes, gastritis, history of ischemic heart disease, and obesity. Dr. Sackel noted in his discharge summary that R.M. had a Cardiolite stress test, which is a very sensitive stress test, while he was hospitalized because R.M. complained of chest pains, that the test results were within normal limits, and that the test results were negative for ischemia. Upon R.M.'s discharge from the hospital, Dr. Carida referred R.M. to a home health agency, although the instructions provided to the agency were based on Dr. Sackel's discharge orders, and the medications R.M. took after his discharge on March 29, 1994, were those ordered by Dr. Sackel. Additionally, Dr. Sackel and his partner, Dr. Paul Quentzel, were identified on the home health agency's treatment plan as physicians who could write orders for R.M. The home health nurse visited R.M. on March 30, March 31, April 1, April 4, April 6, and April 8, 1994. The nurse's notes show that R.M.'s temperature ranged from 97.1 to 98 degrees; that, on April 1, 1994, R.M. reported that his stool was brown/black; that on the other days he was visited by the home health nurse, he reported that his stool was soft and brown. R.M. generally did not feel well after his discharge from the hospital on March 29, 1994. On April 11, 1994, Dr. Carida was told by one of his staff that R.M. had been scheduled for an appointment that afternoon 1/ When R.M. and J.M. arrived at Dr. Carida's office, Dr. Carida observed them sitting in the waiting room, and he noted that R.M. looked pale and semi-lethargic. R.M. was taken into an examination room by one of Dr. Carida's staff, who noted R.M.'s major complaints on the chart maintained by Dr. Carida as part of R.M.'s medical record: R.M. complained that both his feet were swollen, that he had been up all night for three nights, that he had shortness of breath, and that he had been hot and cold all day. At the time of his office visit, his blood pressure was 140/56, and his temperature was 99.1 degrees. When Dr. Carida examined R.M. on April 11, 1994, R.M. told Dr. Carida that he had experienced shortness of breath for two or three days. Because of this complaint and because R.M. had experienced chest pains during his hospitalization in March 1994, Dr. Carida asked R.M. if he had any chest pain at the time of the office visit on April 11, 1994. R.M. denied having any such pain. Because of R.M.'s fever and shortness of breath and because of the possibility of pneumonitis, Dr. Carida asked R.M. if he had any yellow sputum, which R.M. denied. Dr. Carida also asked R.M. if he had coughed up any blood, and R.M. denied having done so. R.M. did not report any dizziness to Dr. Carida, nor did R.M. indicate that his stool was black. Dr. Carida examined R.M., and the examination of his lungs and his abdomen was negative. Dr. Carida noted a mild systolic murmur, which was consistent with the mitral regurgitation noted in the electrocardiogram ordered by Dr. DiGiorgi during R.M.'s March 1994 hospitalization. Dr. Carida ordered two blood tests, a chemical screen to determine if R.M. had a metabolic problem and a "CBC," or complete blood count, to determine if R.M. was anemic or was developing congestive heart failure and to determine if R.M. had an infection. Blood was drawn for these tests by the phlebotomist working in Dr. Carida's office on April 11, 1994. Pursuant to the usual procedure, the blood test results would be available to Dr. Carida the following morning. Dr. Carida told J.M. to bring R.M. to his office the next day, April 12, 1994, for a chest x-ray, and Dr. Carida gave R.M. a stool card to take home with him and told J.M. to return the card the next day so R.M.'s stool could be tested for occult blood. Dr. Carida also gave J.M. two Lasix tablets, which is a diuretic used to help decrease fluid accumulating in the heart and lungs. Dr. Carida instructed J.M. to give R.M. one Lasix tablet that night and the other the next morning. Even though Dr. Carida suspected that R.M. had an infection on April 11, 1994, his suspicion had not yet been confirmed by blood tests. Consequently, Dr. Carida did not prescribe an antibiotic for R.M. or administer an antibiotic by injection because it would not have been appropriate under the circumstances. Antibiotics can mask an infection without curing it and make it difficult to get a blood culture that accurately identifies the source of the infection. Dr. Carida ordered several other tests for R.M., which were done on April 11, 1994, in his office: Dr. Carida ordered an electrocardiogram, which showed non-specific "ST" changes, which can be caused by a number of conditions, including ischemia, a decrease in blood flow to the heart with a resulting lack of oxygen to the heart muscle. However, Dr. Carida did not believe R.M. had ischemia because the stress test R.M. had taken in March 1994, was negative and because R.M. reported on April 11, 1994, that he had no chest pain. Non-specific "ST" changes can also be an indication of sepsis, an infection, or an electrolyte imbalance. Dr. Carida ordered a pulmonary function test because R.M. was experiencing shortness of breath and had a history of chronic obstructive pulmonary disease. The results showed an accumulation of fluid in the lungs and were consistent with congestive heart failure. Dr. Carida ordered a "2-D" echocardiogram. This test uses sound waves to show the valves and the walls of the heart. The results were generally normal and showed normal ejection fraction, which is an indication that ischemia was not present. The test also showed mild aortic valve disease, but no narrowing of the aortic valve. Dr. Carida ordered a cardiac color doppler, which measures blood flow generally and in the heart specifically. The results were consistent with sepsis and also showed an accumulation of fluid in the heart, which is consistent with developing congestive heart failure. After R.M. returned to the examination room after having these tests, R.M. began exhibiting chills and rigors, which are shaking chills that cause the body to move in a rhythmic fashion. At the time, R.M. was sitting in the examination room wrapped in a blanket. When Dr. Carida observed these symptoms and the pallor of R.M.'s skin, Dr. Carida told J.M. that R.M. should be taken to the emergency room immediately. 2/ J.M. told Dr. Carida that she would not take R.M. to the hospital. Dr. Carida did not document on R.M.'s chart his instruction to J.M. to take R.M. to the emergency room on R.M.'s chart or her refusal to do so. Because he needed to see other patients, Dr. Carida asked his staff to talk with J.M. and to try to convince her to take R.M. to the emergency room. As far as Dr. Carida knew at the time, these efforts were unsuccessful. Sometime between 4:00 p.m. and 5:00 p.m., shortly after she and R.M. left Dr. Carida's office, J.M. called Dr. Carida's office and notified a member of his staff that she was taking R.M. to the emergency room after all. Dr. Carida told the phlebotomist to cancel the blood tests and the chest x- ray he had ordered for R.M., which was done before 5:30 p.m., when the office closed for the day. About 11:00 p.m. on April 11, 1994, Dr. Carida received a telephone call from the emergency room at the North Broward Medical Center notifying him that R.M. had been admitted to the hospital. After being briefed by the person from the emergency room, Dr. Carida told the person to call Dr. Sackel, the gastroenterologist, and Dr. DiGiorgi, the cardiologist, who had both treated R.M. during his March 1994 hospitalization and were familiar with his condition. J.M. was aware as a result of the March 1994 hospitalization that Dr. Carida did not attend patients in the hospital. When R.M. was admitted to the North Broward Medical Center, the admitting diagnosis was gastrointestinal bleeding, and R.M. was given a transfusion. In addition, Dr. DiGiorgi diagnosed congestive heart failure on the morning of April 12, 1994, and prescribed Lasix. R.M. was also given several different antibiotics during his hospitalization, which had no effect on the infection that continued to worsen. J.M. telephoned Dr. Carida on April 14, 1994, and told him that R.M. was confused and appeared mentally unstable. Dr. Carida called R.M.'s nurses at the hospital, who did not know much about his condition. Dr. Carida then telephoned Dr. Sackel and Dr. DiGiorgi, who agreed to evaluate R.M. and call him back. Dr. Sonderling, Dr. Sackel's partner, telephoned Dr. Carida and told him that R.M. had taken a turn for the worse and that he was being transferred to the intensive care unit. On April 14, 1994, the physicians attending R.M. proposed doing additional tests and possibly exploratory surgery in an effort to identify the source of R.M.'s infection. R.M.'s family refused further treatment for R.M. even though they were aware of the possibility that, with surgery, R.M. could have recovered completely. R.M. suffered a cardiopulmonary arrest late in the evening on April 14, 1994, and, although R.M. was resuscitated and placed on life support, he remained comatose. J.M. telephoned Dr. Carida on April 15, 1994, and complained that Dr. Carida had not been to see R.M. since his admission to the hospital on April 11, 1994. As a result, Dr. Carida went to the hospital on April 15 and read R.M.'s chart in the intensive care unit. He was shocked at R.M.'s condition. J.M. was very upset with Dr. Carida, and he did not visit R.M. during the April 15, 1994, visit. On April 15, 1994, the family refused any further intervention for R.M., and he was declared legally dead on April 16, 1994, with final diagnoses including gastrointestinal bleeding and congestive heart failure. The final diagnosis is not necessarily the cause of death, and it appears from the hospital records that, in addition to multiple-system organ failure, R.M. suffered from a catastrophic infection in the abdominal area that was ultimately the cause of his death. The notes made on R.M.'s chart by Dr. Carida documenting his examination and diagnosis of R.M. on April 11, 1994, while sufficient to inform Dr. Carida of the important observations and of his diagnosis, are not legible for the most part, and it is virtually impossible to make out most of the written words and abbreviations even when those words and abbreviations are being read aloud. Dr. Carida's own expert witnesses were unable to read his notes. Summary The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Carida practiced medicine below an acceptable standard of care with respect to the care he provided to R.M. during R.M.'s April 11, 1994, office visit. Even given R.M.'s recent hospitalization for gastrointestinal bleeding, Dr. Carida did not fall below the accepted standard of care by failing to perform an orthostatic test during R.M.'s April 11, 1994, office visit. The orthostatic test assists in determining if a person has gastrointestinal bleeding because it can identify if a person is hypovolemic. 3/ A person with hypovolemia has decreased volume of blood in the vascular space, which would be consistent with gastrointestinal bleeding. First, at the time of his office visit to Dr. Carida on April 11, 1994, R.M. had no symptoms that would indicate that he suffering from clinically significant gastrointestinal bleeding, which symptoms would include vomiting blood, black stools, and low blood pressure. Additionally, the results of the echocardiogram, the pulmonary function test, and the cardiac color doppler test performed in Dr. Carida's office on April 11, 1994, showed an excess of fluid in R.M.'s heart and lungs, which is consistent with congestive heart failure, rather than hypovolemia. Even had Dr. Carida performed an orthostatic test on R.M., the results would have been indeterminate because diabetics such as R.M. can have orthostatic hypertension even when they are "normal volemic," that is, when their blood volume is normal. Dr. Carida likewise did not fall below the accepted standard of care by failing to do a digital rectal examination of R.M. on April 11, 1994, to determine if there was blood in his stool. Prior to his instructing J.M. to take R.M. to the emergency room, Dr. Carida intended to do an occult blood test from a stool sample as an alternative to a rectal examination in Dr. Carida's office, and Dr. Carida instructed his staff to give R.M. a stool card home to take home and return the next day. Once R.M. began exhibiting chills and rigors, Dr. Carida appropriately determined that there was a risk that R.M. would have a life-threatening vasovagal reaction to a rectal examination. The evidence presented by the Department is not sufficient to establish that Dr. Carida failed to consider R.M.'s March 1994 hospitalization for gastrointestinal bleeding when Dr. Carida examined R.M. on April 11, 1994; that Dr. Carida failed to obtain an accurate history of R.M.'s complaints and symptoms during R.M.'s April 11, 1994, office visit; that Dr. Carida failed to recognize R.M.'s cardiac symptoms; or that Dr. Carida failed to recognize the emergent status of R.M. during R.M.'s April 11, 1994, office visit. Dr. Carida's failure to record in his notes of R.M.'s April 11, 1994, office visit that he told J.M. to take R.M. to the emergency room and that she refused is not, of itself, sufficient to establish that these events did not occur. Dr. Carida did not fall below the accepted standard of care under the circumstances by instructing J.M. to take R.M. to the emergency room at the North Broward Medical Center rather than calling the hospital and admitting R.M. to the hospital directly. R.M. was experiencing chills and rigors in Dr. Carida's office, and R.M.'s condition generally was worsening. It was generally known among physicians in the community that a patient would likely receive the necessary tests and therapeutic interventions much more quickly if he or she presented in the emergency room than he or she would if directly admitted into the hospital. The evidence presented by the Department is sufficient to establish with the requisite degree of certainty that Dr. Carida did not prepare an adequate record of R.M.'s April 11, 1994, office visit.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Business and Professional Regulation, Board of Medicine, enter a final order: Dismissing Count I of the Administrative Complaint dated November 2, 1998; and With respect to Count II of the Administrative Complaint dated November 2, 1998, finding that Dr. Robert V. Carida violated Section 458.331(1)(m), Florida Statutes (1993), issuing a written reprimand, and imposing an administrative fine in the amount of $250.00. DONE AND ENTERED this 24th day of March, 2000, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO 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 24th day of March, 2000.
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations that Respondent violated the provisions of Subsections 458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient M.R., as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0077248. Respondent is a vascular surgeon, who is not board-certified in his area of practice. On November 27, 2000, Patient M.R., a 70-year-old male, was admitted to ORMC for a right-side carotid endarterectomy. Patient M.R. initially presented to Respondent in October 2000 with a number of health conditions, including chronic obstructive pulmonary disease (related to a 54-year history of smoking), cerebral vascular disease, atherosclerotic changes, and hypertension. Patient M.R. had a significant cardiac condition which resulted in a bypass procedure. It was determined at that time that Patient M.R. had significant stenosis in both carotid arteries which would require Patient M.R. to undergo two separate procedures, known as carotid endarterectomies. The left carotid artery was the subject of the first procedure in October 2000. Patient M.R. tolerated this procedure with no complications. Subsequent to the first carotid endarterectomy, but prior to the second, Patient M.R. suffered a transient ischemic attack (TIA), which is commonly referred to as a "mini-stroke." The symptomatic clinical presentation placed Patient M.R. in a high-risk category for peri-operative stroke. Respondent performed a right carotid endarterectomy on Patient M.R. on November 27, 2000. This requires the clamping of the artery in two locations, using a shunt to allow for the flow of blood. The incision must be made length wise in the controlled portion of the artery using an instrument to clear out the interior or lumen of the artery. This is done to reduce the stenosis and allow for better blood flow, without disbodying any particle from the wall of the artery. Once this is completed, the incision is patched, the clamps and shunt are removed, and the outer skin incision is closed. During the course of the above-described carotid endarterectomy, Respondent used a patch angioplasty with intra- operative shunt, which was manufactured from a pediatric feeding tube, and peri-operative neurologic monitoring. Immediately after the operation, the patient appeared to tolerate the procedure well, but was lethargic. Patient M.R. exhibited good movement in all four extremities and appeared to be neurologically intact, although he underwent extreme fluctuation in blood pressure. Patient M.R. was placed on ventilator support. The next morning, November 28, 2000, Patient M.R. had swelling and a hematoma in his neck on the right side, in the area of the incision. Respondent returned Patient M.R. to surgery, for exploration and evacuation of the hematoma. During the course of this second operation, Respondent observed a lot of swelling and edema in the operative site, but not much blood. Respondent evacuated the hematoma, and the carotid artery was found to have good blood flow. Later in the evening on November 28, 2000, Patient M.R. developed an acute neurologic deficit and was returned to the intensive care unit (ICU) at ORMC. Respondent ordered a Computerized Tomographry Scan (CT Scan) of the patient and an arteriogram. The results of the CT Scan showed a probable right occiptal infarct (stroke). The arteriogram showed significant occlusion of the right carotid artery extending to the carotid siphon. Patient M.R. was returned to the operating room in the early morning hours of November 29, 2000. Respondent made the decision to reopen the surgical area in an effort to resume blood flow in the right carotid artery that was seen to be occluded on the angiogram. Assisting Respondent on this November 29, 2000, procedure were John Horowitz, M.D., a board- certified vascular surgeon with nine years of experience, and Joseph Muller, M.D., a third-year general surgical resident at ORMC. During the November 29, 2000, procedure, Respondent reopended the previous incision in the skin and partially opened the patch that had previously been used over the carotid artery itself. Respondent performed a thrombectomy using a Fogarty "balloon" catheter in an effort to extract any debris that was causing the stenosis in the carotid artery. The balloon is placed into the carotid artery itself and is pushed up into the artery until it has passed whatever occlusion is present. Then the balloon is inflated and pulled back out, pulling with it any debris that is located within the artery. Near the conclusion of this November 29, 2000, procedure, a small piece of tubing was discovered in the surgical field. The piece of tubing was handed to Dr. Horowitz, who examined it and then placed it on the surgical tray. This piece of tubing was the same size, slope, and material cut from the feeding tube which was used as a shunt in the first surgery on November 27, 2000. There is conflicting testimony regarding the precise size and location of this piece of tubing that will be discussed below. What remains undisputed based upon the record in this case is that Respondent completed the surgical procedure on November 29, 2000, by closing the incision in the carotid artery and also in the skin of the neck. Dr. Muller is currently a surgical resident at ORMC, as he was at the time of the November 29, 2000, procedure. Dr. Muller testified that he had approximately two years and five months of residency training prior to the procedure in question. He estimated that he had observed approximately ten to 15 carotid endarterectomies. Dr. Muller testified that he observed a clear and slightly opaque piece of pediatric feeding tube coming out of the lumen of the artery as Respondent was evacuating debris after the inflation of the Fogarty balloon catheter and after about three passes of the catheter. Dr. Muller also testified that the piece of tubing in question was two or three centimeters in length. The other witnesses to this event testified that the piece in question was two to three millimeters in length. Dr. Muller's description of the position of the surgeon and assistant surgeon was also contrary to that of the other witnesses. Dr. Muller also testified that he did not know Patient M.R.'s medical history or his previous hospital course of treatment. Dr. Horowitz, the senior physician assisting, is a board-certified vascular surgeon who has performed several hundred carotid endarterectomies. He testified that he was called in by Respondent to assist on the surgical procedure which took place in the early morning hours of November 29, 2000. He found the piece of tubing located somewhere within the surgical field, remote from the carotid artery. He was certain that it was after Respondent had cleared the artery with the use of the Fogarty balloon catheter and had cleared the surgical wound. Dr. Horowitz testified that he saw a piece of tubing among the debris that had been evacuated from the surgical wound. It was not in the lumen of the artery. He picked up the piece of tubing in question with his thumb and forefinger and examined it. He testified that it was approximately two to three millimeters in length. He agreed that the material was consistent with the pediatric feeding tube that was used to create a shunt for the first procedure. Dr. Horowitz's testimony is credible and persuasive. Dr. Horowitz also gave his opinion that based upon his observation of the November 29, 2000, procedure, he did not believe that Respondent deviated from the standard of care in his treatment and care of Patient M.R. Patient M.R. was returned to the ICU, where he deteriorated and showed evidence of complete lack of brain stem reflexes. Patient M.R. was later pronounced brain dead, and he subsequently died on November 30, 2000. Gregory Schreiber, M.D., was the anesthesiologist who was present for a portion of the November 29, 2000, procedure. Dr. Schreiber testified that he was present during the beginning portion and the end portion of the procedure, when anesthesia is introduced and when anesthesia is abated. He was not present in the operating room when the piece of tubing was found. Further, there was a drape that separates the operative field from the anesthesiologist during the course of this procedure, which would have prevented Dr. Schreiber or his assistant from being able to see into the operative field directly. Dr. Schreiber noted that Patient M.R. was considered a very high-risk patient, whose multiple co-existent diseases posed a constant threat to his life when he presented for this surgery. In addition to the testimony outlined above, Petitioner also introduced three affidavits into evidence. One affidavit was that of Lata Bansal, M.D., a neurologist who was brought in for consultation after the November 29, 2000, procedure. Dr. Bansal swore in her affidavit that when she first saw Patient M.R. he was already brain dead. She otherwise did not have specific recollection of Patient M.R. The affidavit of Peter D. Taylor, M.D., a cardiac specialist, stated that he recommended a Thallium stress test for Patient M.R. prior to carotid surgery. The stress test was conducted on October 17, 2000, and revealed no ischemia but moderately decreased left ventricle function. Because he had no ischemia, Dr. Taylor opined that Patient M.R. was at an increased but acceptable risk for carotid surgery. The affidavit of Marita Lu, Registered Nurse, who was present during the November 29, 2000, procedure, stated that she could remember very few details of Patient M.R.'s case, other than she has the "impression" that something was recovered from the wound and that when she asked whether there was a specimen, she was told there was no specimen. Nothing in her affidavit indicates to whom she asked this question regarding the specimen nor is there any indication who responded to her question. Respondent is a board-certified general surgeon who is eligible for a special certification in vascular surgery and who was working at a vascular surgery group in Orlando, Florida, as of October and November of 2000. Respondent no longer practices in the State of Florida. He currently is an assistant professor of surgery and director of endovascular surgery at Creighton University in Omaha, Nebraska. Respondent described in detail each of the three procedures he performed. On November 27, 2000, the original procedure on the right carotid artery proceeded in routine fashion. Respondent provided an exemplar, which was admitted into evidence, of a pediatric feeding tube which is substantially similar to the pediatric feeding tube utilized in the November 27, 2000, procedure on Patient M.R. He utilizes a portion of the pediatric feeding tube as a shunt in his carotid endarterectomy procedures. He demonstrated at the final hearing that the pediatric feeding tube itself is so flexible as to be incapable of breaking. The only means of cutting it down is through the use of surgical instruments. He also indicated that there was no way to further cut down the tubing once it had been placed. The scrub technician cut the pediatric feeding tube into the appropriate length to be used as a shunt during the November 27, 2000, procedure. Respondent recalled that prior to this particular procedure, the tubing in question was not originally cut down to the appropriate size. It had to be cut down while in the operating room. It is during this cutting of the tubing that a tiny sliver, approximately two to three millimeters in length, was removed from the larger piece of tubing and entered the surgical field. Respondent did not know and did not have any way of knowing that the piece of tubing had entered the surgical field, as he was focused on preparing the artery itself for its incision while this tubing was cut. Respondent testified that the pediatric feeding tube in question was cut down to size before any incision was made in the carotid artery itself. Respondent performed the November 27, 2000, procedure as he normally does. After the procedure, Patient M.R. experienced extreme fluctuations in blood pressure. This can occur in patients due to multiple factors involving the nervous tissue and blood flow in the carotid artery, but there is no specific explanation for why it does happen. Subsequent to the November 27, 2000, procedure, Respondent monitored Patient M.R., addressing the extreme fluctuations in blood pressure along with the consulting physicians referred to above. Respondent noted that Patient M.R. developed a hematoma subsequent to the first procedure. He made a determination that the best course for Patient M.R. would be to evacuate the hematoma. In Respondent's opinion, evacuating the hematoma would speed up the healing process. Respondent performed this procedure on November 28, 2000. Patient M.R. tolerated this procedure well, and there was nothing remarkable about the procedure itself. Respondent palpated Patient M.R.'s artery during the course of this procedure and used the Doppler to reinforce his findings on palpation. A Doppler signal gives more specific information about the varied nature of blood flow in the internal and external carotid arteries. It was not Respondent's standard practice, nor is it necessary, to create a medical record that palpation of the artery has occurred, since it is such a basic and common occurrence that its notation on the record is not deemed to be necessary. Respondent continued to follow Patient M.R. subsequent to the November 28, 2000, procedure. When it was determined that Patient M.R. had suffered a stroke, Respondent was left with a choice of either doing nothing, or reopening the artery in an effort to save Patient M.R.'s life. Respondent chose to reopen the artery in an effort to determine whether anything could be done to save Patient M.R. Respondent opened the prior incision in the carotid artery on November 29, 2000, and inserted the Fogarty catheter in order to evacuate any debris that was located within the carotid artery. Respondent testified that it was at about this time that the piece of tubing was found; however, he further testified that he did not see the tubing in question come from the lumen of the carotid artery. Respondent's testimony is credible. It was Respondent's opinion testimony that the piece of tubing in question was located in the subcutaneous tissue outside of the artery. Its exact location within the various layers of subcutaneous tissue was not observed during the procedure. It was not possible for the piece of tubing in question to have entered the artery at this time. There was no evidence to suggest that the piece could have migrated into the artery at a later time. James Dennis, M.D., is a board-certified vascular surgeon who is the chief of the vascular surgery department at the University of Florida in Jacksonville, Florida. Dr. Dennis has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Dennis testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient M.R. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient M.R., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes. Dr. Dennis also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient M.R. Dr. Dennis' standard of care opinions were based on several factors. First, it was Dr. Dennis' opinion that based upon the contents of the chart, the only time that the piece of pediatric feeding tube could have entered Patient M.R. was during the course of the November 27, 2000, procedure. Dr. Dennis testified that in his opinion, Respondent deviated from the standard of care in allowing the piece of pediatric feeding tube to enter Patient M.R.'s body. This would be his opinion even if Respondent did not see the sliver of tubing in question enter Patient M.R.'s body and even if the piece of tubing in question were so small and translucent as to be practically invisible. Dr. Dennis also testified that in his opinion, Respondent deviated from the standard of care during the November 28, 2000, procedure in that he failed to adequately palpate the carotid artery. Dr. Dennis was critical of Respondent's use of a Doppler to assess Patient M.R.'s pulse. In Dr. Dennis' opinion, the use of the Doppler was indicative a weakening pulse rate and that the proper practice would have been to palpate the artery by touch rather than by using a Doppler instrument. Dr. Dennis was also critical of Respondent during the November 28, 2000, procedure for his failure to find the piece of tubing in question. It is Dr. Dennis' opinion that the piece of tubing had to have been located within the lumen of the artery and that had Respondent adequately palpated the entire length of the carotid artery during the November 28, 2000, procedure, he would have located the piece of tubing within the artery and could have taken appropriate steps to remove the piece of tubing before Patient M.R. suffered his stroke later that night or during the early morning hours of November 29, 2000. Dr. Dennis' opinion that the piece of tubing in question had to have been located in the lumen of the artery was also based upon his assessment of the procedures performed. He discounted the theory that the piece of tubing was located within subcutaneous tissue outside of the artery because, in his opinion, the piece of tubing would have been discovered either during the November 28, 2000, procedure or earlier in the November 29, 2000, procedure if it had been outside the artery. However, according to Dr. Dennis, based upon the timing of when the piece of tubing was found, the tubing itself had to have been located within the lumen of the artery until it was removed in the November 29, 2000, procedure. Dr. Dennis also rendered the opinion that not only was the piece of tubing located within the lumen of the carotid artery, but that the piece of tubing is directly related to the stroke which Patient M.R. suffered later that day or the following morning, which caused his death. Dr. Dennis testified that the piece of tubing became lodged in Patient M.R.'s carotid artery and that as blood flowed by it, platelets attached to the tubing, slowly building up with the carotid artery, until Patient M.R. experienced 100 percent stenosis in the right carotid artery, leading to his stroke. In sum, Dr. Dennis' opinion was that Respondent deviated from the standard of care by allowing a piece of tubing to enter Patient M.R.'s carotid artery and that it was this tubing which lead to Patient M.R.'s stroke and ultimately his death. This is in spite of the fact that Dr. Dennis was not able to state within any degree of medical probability how the sliver of tubing could have entered the artery. Dr. Dennis also rendered an opinion during his final hearing testimony that Respondent deviated from the standard of care because he did not secure the piece of tubing at issue in this case and see to it that the tubing was sent to the pathology laboratory at ORMC for analysis. Morris Kerstein, M.D., a board-certified vascular surgeon, reviewed all of the pertinent medical records reflecting the treatment and care Respondent provided to Patient M.R. Dr. Kerstein had been practicing for 35 years, and he is currently the chief of the vascular surgery department at the Veteran's Administration Hospital in Philadelphia, Pennsylvania. Dr. Kerstein has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Kerstein's opinion based upon his education, training, and experience is that Respondent did not deviate from the standard of care in his treatment of Patient M.R. First, Dr. Kerstein testified that in his opinion, Respondent's conduct during all three procedures at issue was appropriate. As to the November 27, 2000, procedure, there was no way for Respondent to be aware that the piece of pediatric feeding tube had entered the operative field. It was too small to be noticed, and it was of a translucent color which made locating it extremely difficult. He was not critical of Respondent for not cutting the tubing himself. He testified that if, in fact, the sliver of tubing entered the surgical area as a result of the scrub technician cutting the tubing, and a two to three millimeter fragment jettisoned into the surgical field, this would not constitute a deviation from the standard of care by Respondent. Dr. Kerstein testified that he felt the November 28, 2000, procedure was performed appropriately as well. He testified that it was not a deviation for Respondent to use a Doppler to feel for pulses in the arteries, and to the contrary, it reveals that Respondent was being meticulous beyond what the standard of care requires. He opined that Respondent certainly would have palpated the arteries in question, and to suggest otherwise based on the absence of a note to that effect is not an appropriate conclusion to draw. Dr. Kerstein rendered the opinion that he did not believe that the piece of tubing in question was located within the lumen of the artery of Patient M.R. He testified that there was no way for the tubing to enter the artery because the sliver in question came off of the longer tubing before an incision was made in the carotid artery. There is therefore no reasonable explanation as to how the piece in question could have entered the carotid artery in the first place. Dr. Kerstein also disputed the theory that not only was the piece of tubing located within the lumen of the artery, but also the piece in question actually caused Patient M.R.'s stroke. Dr. Kerstein relied principally on the radiographic studies. Both the CT Scan of the brain and the angiogram taken late in the evening of November 28, 2000, revealed a right posterior occipital infarct. The posterior of the brain is the back of the brain, and if the infarct was located there, it means that the cause of the stroke had to be something other than an occlusion in the carotid artery. This is because the arteries that feed the back portion of the brain are the basilar and vertebral arteries, not the carotid artery. Therefore, there could be no possible causal connection between the sliver in question and Patient M.R.'s stroke. Dr. Kerstein's opinion as to the cause of Patient M.R.'s stroke focused on his personal history rather than on the events of November 27, 2000. He noted that Patient M.R. presented with severe atherosclerotic changes, indicative of an advanced disease process. He noted that Patient M.R. suffered from chronic obstructive pulmonary disease, which was the product of his 54-year smoking history. He also noted Patient M.R.'s significant cerebrovascular disease. He also stated that thrombosis (or clotting of the blood) is a known complication of this procedure and can happen for several plausible reasons other than a sliver of tubing in the artery. All of these conditions conspired to predispose Patient M.R. to suffer a significant event such as the stroke he suffered on November 28 through 29, 2000. Dr. Kerstein also noted that the piece of tubing was completely inert, and given its size and its location in the subcutaneous tissue outside of the carotid artery, the tubing would have had no impact whatsoever on Patient M.R.'s prognosis. The tubing in question is an example of inert material that can remain inside the body, such as the case of a bullet which is located too close to the spinal cord to allow for an operation to remove it, without causing the body any harm. Dr. Kerstein had no criticism of the medical records Respondent kept regarding the treatment he provided to Patient M.R. He specifically noted that the records were accurate and honestly reflected what had occurred during the procedure. The fact that no foreign object was noted in the first two procedures was appropriate because at that point, he had no reason to suspect the presence of a foreign object. The lack of reference to a cause of Patient M.R.'s atypical post-operative course was appropriate because in fact Respondent could not have defined a single reason why Patient M.R. was reacting the way he did. Finally, the operative note from the November 29, 2000, procedure was appropriate, as it also honestly and accurately depicted what had occurred; he made a specific comment on Respondent's note that the sliver was not indeed from the lumen, but that the exact location was unclear, finding this to be an unambiguous statement of fact. Dr. Kerstein also disagreed with the state's position with regard to the responsibility for maintaining possession of the piece of tubing post-operatively. Dr. Kerstein testified that it was the responsibility of the circulating nurse, an employee of the hospital, to arrange for the piece of tubing to be sent to the pathology lab for examination. The evidence is insufficient to support Petitioner's contention that the pediatric feeding tube sliver at issue caused Patient M.R. to suffer a stroke because of its location within the carotid artery itself. Radiographic studies were performed on Patient M.R. after the stroke. A CT Scan performed on November 28, 2000, revealed an acute right posterior cerebral artery distribution infarct. Further, a cerebral angiogram was performed on November 28, 2000, and revealed "markedly diseased circulation particularly in the right vertebral and basilar arteries." This note also revealed: "Severely diseased posterior fossa circulation." Based upon the location of the infarct in Patient M.R.'s brain, the cause of the stroke had to have been either the vertebral or basilar arteries that supply blood to the posterior part of the brain. In view of all the evidence, the expert testimony of Dr. Kerstein, together with that of Dr. Horowitz, was more persuasive than that of Dr. Dennis in regard to the standard of care and Respondent's actions in this matter.
Recommendation Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated either Subsections 458.331(t) or (m), Florida Statutes, in his treatment of Patient M.R. and that the Administrative Complaint be dismissed. DONE AND ENTERED this 9th day of June, 2003, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2003. COPIES FURNISHED: Michael D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. 390 North Orange Avenue Suite 1000 Orlando, Florida 32802 Daniel Lake, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Petitioner's name and address are North Broward Hospital District d/b/a North Broward Medical Center, 201 E Sample Road, Pompano Beach, Florida 33604. The North Broward Hospital District is a Special Taxing District created by the Florida Legislature. It currently owns and operates three public, nonprofit hospitals in Broward County including Broward General Medical Center ("BGMC") and North Broward Medical Center Respondent, Department of Heath and Rehabilitative Services ("HRS"), is responsible for the administration of Section 381.493 through 381.499, Fla. Stat. ("the CON statute"), and Fla. Administrative Code Ch. 10-5 ("the CON rules"). Under the foregoing, authorities, HRS reviews applications for CONs to construct, purchase or otherwise implement certain new health care facilities and new institutional health care services, as defined by the CON statute. One of these new institutional health care services subject to HRS' review under the CON statute and CON rules is open-heart surgery service, as defined in Fla. Admin. Code Rule 10-5.11(16)(a). By formal application under the CON statute and CON rules which was deemed complete by HRS effective October 16, 1985, NBMC applied for a certificate of need ("CON") to institute an open-heart surgery service at 201 E. Sample Road, Pompano Beach, Florida 33604. Exhibit "A" is a true, correct, and authentic copy of NBMC's application for certificate of need for open-heart surgery. NBMC's application was denied by HRS by letter dated February 28, 1986, received by NBMC open March 10, 1986. Exhibit "B" is a true, correct, and authentic copy of said letter. Publication of the denial appears at Vol. 12; No. 11, Florida Administrative Weekly (March 14, 1986). HRS' basis for denying the application is contained in the "State Agency Action Report". Exhibit "C" is a true, correct, and authentic copy of HRS' State Agency Action Report pertaining to NBMC's application. NBMC has petitioned HRS for formal Section 120.57(1), Fla. Stat., administrative proceedings challenging the denial of its application for open- heart surgery. Exhibit "D" is a true, correct, and authentic copy of that petition. In its application, NBMC stated that one of its sister hospitals, BGMC, currently provided open-heart surgical services. NBMC proposed in its application to utilize the same open-heart surgical team at NBMC as was then practicing at BGMC. Applicants for CONs for open-heart surgery services must satisfy certain regulatory standards prescribed in CON Rule 10-5.11(16). These standards include: (k)1. There shall be no additional open- heart surgery programs established unless: The service volume of each existing and approved open-heart surgery program within the service area is operating at and is and expected to continue to operate at a minimum of 350 adult open-heart surgery cases per year or 130 pediatric heart cases per year; and The conditions specified in (e)4., above will be met by the proposed program. (E.S.) Rule 10-5.11(16)(e)4. provides in pertinent part as follows: There shall be a minimum of 200 adult open- heart procedures performed annually, within three years after initiation of service, an any institution in which open-heart surgery is performed for adults. (E.S.) Exhibit "E" is a true, correct, and authentic copy of CON Rule 10-5.11(16). 10. In 43 Fed. Reg. 13040, 13048 (March 28, 1978) (42 C.F.R. 121.207), the Secretary of the United States Department of Health and Human Services ("HHS") set forth the federal CON standards for open-heart surgery, as part of the National Guidelines for Health Planning. The National Guidelines for Health Planning are referenced in HRS's State Agency Action Report. Exhibit "F" is a true, correct, and authentic copy of that portion of the Nation Guidelines for Health Planning which pertain to the implementation of open-heart surgery services. The National Guidelines for Health Planning also provide that approval of new open-heart surgery services should be contingent upon existing units operating and continuing to operate at a level of at least 350 procedures per year. The National Guidelines for Health Planning further provide as follows: In some areas, open-heart surgical teams, including surgeons and specialized technologists, are utilizing more than one institution. For these institutions, the guidelines may be applied to the combined number of open-heart procedures performed by the surgical team where an adjustment is justifiable in line with Section 121.6(B) and promotes more cost effective use of available facilities and support personnel. In such cases, in order to maintain quality care a minimum of 75 open-heart procedures in any institution is advisable, which is consistent with recommendations of the American College of Surgeons. (E.S.) HRS' CON Rule 10-5.11(16); which contains the "350" standard, does not contain any comparable exception for institutions sharing open-heart surgical teams. NBMC's application for CON projects 200 open-heart surgeries by the end of the third year of operations and, when combined with BGMC's open-heart procedures satisfies the exception contained in the National Guidelines for Health Planning, as described above. There are no disputed issues of material fact that will require an evidentiary hearing in this matter. The parties therefore agree that the matter shall be submitted pursuant to legal memoranda and oral argument. The parties' legal memoranda will be due on June 17, 1986, and oral argument will be held on the scheduled hearing date of June 19, 1986. The parties agree to allow responses to the legal memoranda, which responses shall be submitted no later than June 26; 1986.
