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.
Findings Of Fact At all times material hereto, Respondent has been licensed to practice medicine in the State of Florida, having been issued license number ME 0034265. In the course of his medical practice, Respondent examined and/or treated the following patients during the following time periods: Marisella Conde January 25, 1980 through March 31, 1980 Pedro B. Conde February 23, 1980 through April 14, 1980 Michelle Conde February 26, 1980 through February 27, 1980 Ana Franjul January 20, 1981 Alfonso deLaTorre September 11, 1980 through November 3, 1980 Zoraida Estrada March 5, 1980 through January 7, 1981 Maria Estrada June 1, 1981 Dulce Febles June 30, 1980 through June 9, 1981 Maria Febles August 5, 1980 through October 17, 1980 At all times material here to, Respondent had in his office a Dow Spectophotometer, a table-sized colorimeter manufactured by Dow Chemical Company and used to diagnose the chemical content of blood. The machine compares the color of a particular reagent with the color of a patient's plasma sample and gives a reading which is interpreted by the physician to achieve a diagnosis. A different, specific reagent is used to achieve each specific component analysis of a plasma sample. The plasma must first be separated from the blood sample by centrifuge, which separates the whole blood from the plasma. The plasma sample must be manually, individually prepared for each specific blood analysis desired and must pass through seven different steps in the Dow machine before completion. A separate vial of plasma and reagent must be manually prepared for each specific blood component test, such as cholesterol or bilirubin, and must be individually loaded into the Dow machine. The machine processes one vial at a time. Each analysis test is prepared separately and manually only the ultimate reading is performed automatically by the machine. The reading is then interpreted by the physician. In September or October 1981, Respondent replaced his Dow machine with an ACA II, a room-sized computer/clinical analyzer manufactured by the Dupont Company and used to analyze blood samples. Respondent is the only private Florida physician known to own and operate an ACA II in his office. The ACA II is in use by several hospitals in the Miami area. The SMAC machine is manufactured by the Technicon Company and is one of the first automated blood analysis machines available. The machine takes one blood sample and is capable of performing up to 26 different analyses from the one blood sample loaded into the machine. It does not require separate, manual preparation of a blood sample for each analysis, as do the Dow and the ACA II machines. The SMAC machine inserts the same needle device into the blood sample for each analysis performed and inserts the same needle device into the blood samples of different patients loaded into the machine. The Technicon SMAC machine is not as accurate as the ACA II machine. Although the Technicon SMAC machine is as accurate as the Dow machine, tests run on the Dow colorimeter have more quality control, since blood samples are individually analyzed and not mixed. The word "SMAC" has come to be generically used by physicians to mean blood tests performed on any type of machine. Thus, the term "SMAC" is generic for blood tests as the word "Frigidaire" is generic for refrigerators. Physicians refer to blood tests as "SMAC 22" or "SMAC 26" to denote a blood test involving 22 or 26, or any other number of analyses, without meaning a blood test performed on Technicon's SMAC machine. Respondent follows the practice of-most other physicians in indicating on his billings that a "SMAC 26" test has been performed, for example, which simply means that a blood test of 26 analyses has been performed. When Respondent billed for "SMAC" tests with each of the nine patients named in the Administrative Complaint, his billing used the word "SMAC" followed by the number of analyses, such as "SMAC 22" or "SMAC 26," and then specifically referred the reader to the attached page. The attached sheet of paper itemized each test included within the battery of analyses and the specific fee being charged by Respondent for each individual analysis. Accordingly, Respondent's use of the generic heading next to the total cost for the blood testing, followed by an itemized listing of each individual analysis together with its specific fee, reflects the chemical analyses as being actually performed as separate blood tests individually processed rather than blood testing run by a Technicon SMAC machine. Respondent's method of billing is an appropriate way to bill a patient for individual tests performed, since Respondent was not using a machine which produces multiple readings from one blood sample loaded into the machine. Occasionally, Respondent used an independent laboratory to perform the blood test as a double check to the test performed in his office by him. In those instances, he did not bill for the independent laboratory test. Respondent himself performed the blood tests for which he billed in the manner in which he billed, each test being performed separately and individually as billed. Respondent advised each of the patients named in the Administrative Complaint as to the use and costs of the tests he intended to perform before performing them, thus obtaining his patient's consent to both the testing and the charges therefor. There are no standards in the practice of medicine prohibiting the use of a Dow machine. There is no maximum fee which can be charged by a physician for laboratory tests, throat cultures or hospital visitations. Petitioner based its entire case on two discovery depositions taken by the Respondent: the deposition of a physician serving as a consultant to Petitioner on this case, and the deposition of a physician employed by an insurance company to whom Respondent sent billings for several of the patients named in the Administrative Complaint filed herein. Both doctors based their opinions on the assumptions that Respondent did not have the equipment in his office capable of testing as was reflected in Respondent's billing, that Respondent did not perform the blood tests but rather had them performed by an independent lab, and that the equipment which Respondent allegedly used could not be purchased. Neither doctor has ever discussed Respondent's billing practices with Respondent or with the patients in question, neither has ever seen Respondent's office or equipment, and neither has examined any of the patients in question nor caused any of the patients in question to be examined. Although each doctor believed that Respondent's charges for testing and examination were excessive, that many of the procedures utilized by Respondent were unnecessary, that Respondent inadequately explained his billing, and that the frequency with which Respondent repeated chemistry profiles on his patients was not medically justified, both doctors admitted that they had inadequate information upon which to support their medical opinions for the reason that both doctors based their entire testimony on only the billings that Respondent rendered to each of the patients; and neither doctor had ever seen any of the patient's medical records, which records include Respondent's office notes which contain the results of his examination of the patients, his impressions, his reasoning for each diagnosis, and his intended course of treatment. Long before the filing of the Administrative Complaint in this cause, the insurance company which referred this matter to Petitioner for investigation sent its own investigator to Respondent's office to ascertain if Respondent had the equipment necessary to perform individual blood testing. The insurance company investigator reported Respondent had much equipment, including the Dow Spectophotometer. Yet that insurance company requested an investigation by Petitioner. Petitioner then sent its investigator to Respondent's office to ascertain if Respondent owned any testing equipment. Respondent showed his machinery, specifically the Dow Spectophotometer, to Petitioner's investigator and demonstrated the equipment by taking a blood sample from the investigator and performing the individualized testing on that sample on the Dow machine. As a result of that demonstration, Petitioner's investigator became a patient of the Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty of the charges contained in the Administrative Complaint filed herein and dismissing the Administrative Complaint filed against him. DONE and RECOMMENDED this day of April, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, 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 20th day of April, 1983. COPIES FURNISHED: Spiro T. Kypreos, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Paul W. Lambert, Esquire Stephen Marc Slepin, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Directors 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Southwest Florida Blood Bank, Inc., is a nonprofit community blood bank operating principally in the Tampa Bay Area. It operates a number of facilities known as "transfusion services" in hospitals in the Tampa Bay Area. It has paid separate licensure fees for three of these facilities. Leon County Blood Bank, Inc., is a nonprofit community blood bank operating in Leon County, Florida. It operates several facilities known as "transfusion services" within the County. It has been required to pay separate licensure fees for one of these facilities. No evidence was presented as to Petitioner Jacksonville Blood Bank, Inc. No evidence was presented as to Petitioner Florida Association of Blood Banks, Inc., although the parties did stipulate that it is a trade group which develops professional standards. "Blood banking" is an activity which involves administrative and medical functions in making available for transfusion to patients human blood and blood components. The operational procedures of a blood bank typically involve recruiting activities to attract volunteer donors. These donors are screened, questioned, and evaluated for suitability. If suitable, a blood donation is voluntarily obtained. Screening and collection procedures involve performance of a hematocrit, hemoglobin and blood typing. These procedures are clinical laboratory procedures subject to regulation under Chapter 483, Florida Statutes. They provide information about the health of the prospective donor and the suitability of blood for ultimate transfusion. Blood is typically collected at either the principal blood bank facility or at remote collection stations sometimes referred to as branch offices or mobile donor units. Blood is infrequently collected at facilities known as transfusion services. Once the blood is collected, it is processed using a variety of test procedures including antibody screens, serologic tests, and other procedures to determine the suitability of blood for storage prior to a need for ultimate transfusion. Human blood can be and is frequently separated into various blood components. Separation into components can occur before or after various test procedures are performed. Once the blood or components have been completely processed, the label is identified as to blood type and immunohematologic properties. The blood is then stored until it is needed for transfusion. All of these procedures typically occur in the principal blood bank facilities and are referred to as processing. Before blood can be transfused to a patient, further procedures must be performed. When a physician orders blood or a blood component for transfusion to a patient, a sample must first be obtained from the intended patient/recipient. The patient's sample is then mixed with a sample of blood or blood component obtained by donation in order to test compatibility. This procedure is known as a crossmatch. If the blood is determined to be compatible, then it is provided to the hospital for transfusion to the patient/recipient. The hospital will then either transfuse the blood or store it awaiting transfusion. Crossmatch procedures are often performed in the principal blood bank facility. However, they are also performed in facilities known as "transfusion services" located in hospitals. These facilities are operated both by hospitals and blood banks. Blood collection is usually performed in the principal blood bank, a collection station branch office or a mobile donor unit. Processing is typically done at a central location. Blood banks frequently rent or lease space in hospitals in which they operate facilities referred to as "transfusion services." These facilities have the capacity to store limited amounts of blood and to perform crossmatch procedures when blood or a blood component is requested for transfusion to a patient/recipient. A "collection station" is a remote location in which the only activity is the collection of blood from donors. The Southwest Florida Blood Bank (hereinafter "SWFBB") operates multiple locations in which it collects blood. It also operates four mobile donor units. The SWFBB performs the majority of its procedures at its principal location near the University of South Florida. This facility is licensed by the Department and a licensure fee is paid. SWFBB leases or rents space in hospitals at Tampa General Hospital, St. Joseph's Hospital, Humana-Brandon Hospital and a new facility known as Women's Hospital. It performs crossmatch procedures at each of these locations. The Department has required separate licensure and payment of a separate fee for each facility. SWFBB also provides blood and blood components to a number of hospitals in which the hospital performs the crossmatching. The Leon County Blood Bank (hereinafter "LCBB") performs crossmatch and compatibility testing at its principal location for blood supplied to hospitals. LCBB also leases or rents space at Tallahassee Memorial Hospital and Tallahassee Community Hospital where it provides personnel to perform crossmatch and compatibility testing procedures within the hospital. The Department requires separate licenses and payment of separate fees for facilities located at Leon County Blood Bank and Tallahassee Community Hospital. (It does not charge a separate fee for the facility located within Tallahassee Memorial Hospital because LCBB is located on property adjacent to the hospital, but it does require separate licensure.) The LCBB also provides blood to hospitals in nearby counties where the hospital operates a transfusion service to perform the crossmatch. The Department has defined the activities which it considers to be a "transfusion service." They include the performance of therapeutic pheresis; preparation of red blood cells; recovery of human plasma; and collection of blood. According to the Department, these activities do not require licensure. However, activities involving crossmatching, prenatal immunohematology procedures or other procedures for therapeutic administration of blood or blood components are considered to be clinical laboratory procedures and require a separate license. Hence, they are not activities of a "transfusion service" according to the Department. The separation of activity the Department has established fails to comport with any breakdown recognized or applied in the medical, blood bank or hospital industry. All witnesses who testified indicated that a "transfusion service" has always included the activity of crossmatching or compatibility testing of blood. Dr. Paul Schmidt, a preeminent national authority in blood banking with over thirty years experience, testified "transfusion service" has always included the activity of crossmatching. This was confirmed by Dr. Malloy who has been involved in both national and state blood banking for over twenty years. Their understanding is further confirmed by the Department's own witness, Laura Phillips, who was responsible for promulgation of the challenged rule. No witness who testified could identify a single instance in which a "transfusion service" operates in the manner of the activities broken down by the Department in its rule under challenge in this cause. The Department's exclusion of crossmatching procedures from the definition of "transfusion service" contradicts the historical meaning of the term and the functional breakdown of activities which exist and have always existed in the industry. Dr. Schmidt and Dr. Malloy testified without contradiction that a transfusion service does not collect blood. Furthermore, neither is aware of any transfusion service which has ever been involved in continuous blood collection. The Department offered no evidence of a facility which engages in such activity. Both Dr. Schmidt and Dr. Malloy admitted that preparation of red blood cells and recovery of human plasma could be done in a transfusion service, but that these activities as a matter of practice were generally done in a blood collection and processing facility. Neither is aware of any entity or facility which has performed the various functions which the Department attributes to a transfusion service in their rule. The Department has never attempted to ascertain whether facilities exist which meet the definition contained within their rule. The only facilities which the Department could identify as meeting their definition were "collection stations or mobile units." Finally, the testimony is uncontradicted that crossmatching is inherently a function of a "transfusion service." Authoritative medical and industry standards as well as state and federal regulations uniformly include the function of crossmatching within the activities performed by a "transfusion service." The American Association of Blood Banks Standards, which are the most comprehensive recognized standards existing within the United States and perhaps the world, define and refer to a transfusion service as including the functions of "storing, crossmatching and issuing blood for transfusion." These standards are applied by organizations such as the Joint Commission on Accreditation of Hospitals and the College of American Pathologists in defining hospital practice and inspection procedures. The Department itself uses these standards. It has entered into an agreement for alternate-year inspections of blood banks and transfusion services with the AABB which adopts the AABB standards and guidelines, including the definition of a "transfusion service." The federal Health Care Financing Administration has adopted a definition for "transfusion services" which includes the crossmatching and compatibility testing of blood. The federal Food and Drug Administration also defines transfusion service as involving compatibility testing. More importantly, the Department has been delegated inspection responsibilities under federal regulations and pursuant to federal regulations in determining qualifications for Medicare reimbursement certification. Finally, the Department's own survey reports contain reference to "transfusion service" in the context of procedures which include activities involving crossmatching and compatibility testing. The Department acknowledges that its rule definition of "transfusion service" is inconsistent with federal regulations as well as their own practices and procedures. The Department justifies its rule distinction between those activities which are referred to as a "transfusion service" and those activities which are not and require licensure and payment of a separate fee, by claiming that certain activities performed by "transfusion services" are not "clinical laboratory procedures". However, even this explanation is contradicted by the evidence. The testimony is uncontradicted that collection of blood involves performance of procedures known as hemotocrit, hemoglobin and blood typing. These procedures are acknowledged to be clinical laboratory procedures. Hence, under the Department's own analysis, a "transfusion service" performing collection of blood would be a clinical laboratory and thus fail the Department's rule definition. The Department has required payment by SWFBB and LCBB of licensure fees for facilities which each leases or rents at hospitals where the principal activity is the crossmatching and storing of blood of transfusion. The most recent separate fee charge for each of these facilities is $750.00 per year per facility. The Department is not able to cite any authority, standard or state or federal regulation consistent with its definition of transfusion service. It is unable to identify any facility which has met, or in the future would meet, its definition. Petitioners have stipulated that transfusion services are a kind of clinical laboratory and are thus subject to separate licensure as a clinical laboratory.
The Issue The issue in this case is whether Respondent, Manuel Alvarado, M.D., committed violations of Chapter 458, Florida Statutes, as alleged in an Administrative Complaint issued by Petitioner, the Department of Health, on July 19, 2005, in DOH Case Number 2004-00926, and amended by Order entered March 31, 2006; and, if so, what disciplinary action should be taken against his license to practice medicine in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. (2005). (Admitted Facts). Respondent, Manuel Alvarado, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 59124. (Admitted Facts). Dr. Alvarado has been licensed in Florida since 1991. Dr. Alvarado's mailing address of record is 1414 East Main Street, Leesburg, Florida 34748. (Admitted Facts). Dr. Alvarado has practiced medicine in Leesburg, Florida since June 1991. Dr. Alvarado is board-certified in Obstetrics and gynecology. (Admitted Facts). No evidence that Dr. Alvarado has previously been the subject of a license disciplinary proceeding was offered. Patient O.C. At issue in this case is Dr. Alvarado's treatment of Patient O.C., on August 18 and 19, 2003. Patient O.C. at the times relevant in this case was 25 years of age. Patient O.C., at all times relevant, was pregnant. This was Patient O.C.'s first pregnancy. After becoming pregnant, Patient O.C. utilized Advanced Obstetrics and Gynecology (hereinafter referred to as "Advanced") for pre-natal care. Advanced, located in Leesburg, Florida, was at the times relevant to this matter a group practice conducted by Shivakumar Hanubal, M.D., and Dr. Alvarado. Patient O.C. was attended primarily by Dr. Shivakumar, but she was also seen on one or two occasions for pre-natal care by Dr. Alvarado. Patient O.C. was a High-Risk Patient. Patient O.C. was considered to be a "high-risk" patient due to three factors. First, Patient O.C. was obese. When she first reported for pre-natal care she weighed approximately 285 pounds. Her weight increased to between 300 and 330 pounds by August 18, 2003. Obesity is considered a "high-risk" factor because obese patients generally have a higher risk for gestational diabetes, preeclampsia,7 and a large fetus. Additionally, obesity results in additional problems during labor including an increased incidence of cesarean section delivery. Secondly, Patient O.C. was diagnosed with gestational diabetes, which occurs in some women during pregnancy. Gestational diabetes can cause the baby to be large or "macrosomic," which in turn can cause complications during delivery. It can also cause an excess amount of amniotic fluid, referred to as polyhydramnios. There is also a higher rate of fetal mortality when gestational diabetes is present. Gestational diabetes can, however, be controlled and, in the case of Patient O.C., it was. Finally, Patient O.C. smoked cigarettes. She smoked both before and during her pregnancy. Smoking reduces oxygenation to the uterus, placenta, and the fetus. This increases the risks of intrauterine birth growth restriction and increases the risk of placental abruption (where the placental sheers off the wall of the uterus) as well. Dr. Alvarado was aware that Patient O.C., due to her weight, the gestational diabetes, and her smoking, was a "high risk" patient. The evidence failed to prove that Dr. Alvarado failed to consider this fact in his treatment of Patient O.C. The Events of August 18, 2003. On August 18, 2003, Patient O.C. noticed that she had begun to discharge mucus with pinkish streaks/dark brown spots. (Admitted Facts). Becoming concerned, she telephoned Advanced, and after speaking with someone at Advanced's answering service, received a telephone call from Dr. Alvarado, who was the "on call" obstetrician at Leesburg Regional Medical Center (hereinafter referred to as "Leesburg Regional") that day. (Admitted Facts). Dr. Alvarado was also the on-call physician for Advanced. Dr. Alvarado had arrived at Leesburg Regional at approximately 6:00 a.m., August 18, 2003, where he remained until sometime after 2:15 a.m., August 19, 2003. (Admitted Facts). Dr. Alvarado spoke with Patient O.C., who advised him of the mucus discharge. When he asked whether she had felt any fetal movement, she indicated that the baby was moving but "not as usual."8 (Admitted Facts). Dr. Alvarado advised her to go to the labor room of Leesburg Regional for a non-stress test.9 (Admitted Facts). Dr. Alvarado contacted the labor room to report that Patient O.C. was to be evaluated and asked that a non-stress test be performed on her and that he be informed of the results. (Admitted Facts). As directed, Patient O.C. presented to the Leesburg Regional maternity unit at approximately 8:05 p.m. (Admitted Facts), after initially reporting to the emergency room. Dr. Alvarado was contacted about Patient O.C. at about 8:30 p.m., at which time he gave a verbal order to place an external fetal heart monitor on Patient O.C. (Admitted Facts). A fetal heart monitor measures the heart beat of a fetus. The measurements are recorded continuously on a fetal heart rate monitor strip. Initially, upon placement of a monitor, a "baseline" rate is determined. The base line rate is the mean heart rate per minute of the fetus measured over approximately a ten-minute interval. A "normal" baseline heart rate will range from 120 beats to 160 beats per minute. Once the baseline heart rate is established, the heart rate of the fetus is monitored for expected variations in the heartbeat rate. It is normal for the heartbeat rate to accelerate and decelerate from the baseline rate over an extended period of time. In addition to monitoring the fetal heartbeat rate, the contractions of the mother are also monitored. When a contraction occurs, it is expected that the fetal heart rate will decelerate abruptly. This deceleration is normal and is considered reassuring if the deceleration abruptly ends in less than 30 seconds after it begins. A primary purpose for monitoring contractions and the fetal heart rate is to give the physician assurances that the fetus is not experiencing hypoxia (lack of oxygen to the brain). While variable decelerations and accelerations in heartbeat are expected and considered reassuring, a "late" deceleration is not. A "late" deceleration is a decline in the heart rate from the baseline which takes place just after the peak of a contraction and lasts for 60 seconds or more. A late deceleration can be an indication of fetal hypoxia if it is followed persistently by other late decelerations and a lack of good variability between such events. Fetal heart rate monitors may be placed externally or internally. An external monitor is placed on the mother's stomach and utilizes Doppler waves which are projected at the fetus and are then interpreted by computer to determine the fetal heart rate. An internal monitor requires that the mother's membrane be ruptured, releasing the amniotic fluid, and that the cervix is dilated at least one or two centimeters. An electrode is then placed directly on the scalp of the fetus. Contractions may also be monitored internally using an intrauterine pressure catheter that records the actual pressure of contractions. Dr. Alvarado's instructions to place an external monitor on Patient O.C. were followed by Ann Willis Wimberly, R.N. Due to Patient O.C.'s size, however, it was difficult to obtain a good reading of the fetal heart rate or Patient O.C.'s contractions. Patient O.C. was also somewhat noncompliant with her care, causing further difficulty obtaining accurate readings. Nurse Wimberly also took and recorded a "history" of Patient O.C., including her weight and the facts that she had gestational diabetes, smoked a pack of cigarettes a day, reported "brownish stuff" coming out of her, and had experienced pelvic pressure that day. Nurse Wimberly performed a vaginal examination of Patient O.C. and reported that she was "closed, thick [sic] minus three, palatable" which means that Patient O.C.'s cervix was not open, she was not thinning out, and the baby was still high up and ballottable, which in turn means there was fluid around the baby. At 8:30 p.m. Dr. Alvarado evaluated Patient O.C. and reviewed the fetal heart monitor strip. (Admitted Facts). The baby's fetal heart rate base line was determined to be between 160 and 170 beats10 per minute. (Admitted Facts). This heart rate was above the normal base line expected for a fetal heart base line rate. At this point, the fetal heart monitor had recorded some accelerations, but no decelerations. Patient O.C. had only been monitored for approximately 10 to 15 minutes at the time Dr. Alvarado reviewed the fetal heart rate monitoring strips. This was, as Dr. Alvarado acknowledged at hearing, an inadequate period of time to get adequate data. At 8:40 p.m., Dr. Alvarado left Patient O.C. to attend to a patient in labor. (Admitted Facts). At this time Patient O.C. was essentially stable and the baby's heart rate was essentially within the base line established upon Dr. Alvarado's initial review of the fetal heart monitor strip. (Admitted Facts). Nurse Wimberly continued to monitor Patient O.C.'s fetal heart rate and found that she was experiencing variable accelerations and decelerations, which were reassuring. At approximately 8:50 p.m., Patient O.C. experienced four decelerations. Between 8:50 p.m. and 10:00 p.m., nothing was recorded following a few decelerations. Dr. Danna was unable to identify the decelerations as "late," in part due to the lack of good contraction information. This period was followed by readings which Dr. Danna described credibly as "very sketchy over the next one [strip panels] and the next one and next one, very sketchy." Transcript, Volume I, Page 148, Lines 8-9. From then until early the next morning, there continued to be what may have been late decelerations, but due to the inadequacy of the data as to Patient O.C.'s contractions, Dr. Danna was unable to state convincingly that late decelerations were in fact taking place. A nitrazine test was performed on Patient O.C. at approximately 10:30 to 10:35 p.m. when Patient O.C. complained of brownish fluid leaking out. A nitrazine test measures the pH level in the vagina. The test was positive. This is an indication that delivery should occur within 24 hours.11 At 11:16 p.m., a nurse called Dr. Alvarado and informed him that the baby was moving well. (Admitted Facts). Patient O.C. had denied any further contractions and asked to go home. (Admitted Facts). The nurse informed Dr. Alvarado of these facts. Dr. Alvarado was attending another patient and asked Patient O.C. to wait for his evaluation before going home. (Admitted Facts). The Events of August 19, 2003. At 12:31, a.m., August 19, 2003, Dr. Alvarado attended Patient O.C. (Admitted Facts). When he entered the room in which Patient O.C. was located, Patient O.C. was sitting on the end of the bed ready to go home. (Admitted Facts). The external fetal heart monitor had been removed and she denied having any contractions. (Admitted Facts). Patient O.C.'s "significant other," however, reported more leaking of fluid. (Admitted Facts). Dr. Alvarado was informed that a second nitrazine test was positive. (Admitted Facts). Dr. Alvarado examined Patient O.C., performing a nitrazine test and reviewed her fetal heart monitor strip. (Admitted Facts). The nitrazine test was again positive. Dr. Alvarado decided to admit Patient O.C. to Leesburg Regional. (Admitted Fact).12 While the results of the external fetal heart monitor were not conclusive, Nurse Wimberly became concerned enough with the results to suggest to Dr. Alvarado that she was seeing decelerations which she characterized as sometimes "variable" and sometimes "late." This conversation took place at approximately 12:50 a.m. Dr. Alvarado disagreed with Nurse Wimberly's characterization of the decelerations as "late." Nurse Wimberly did not insist nor record in her notes that there were late decelerations because of the difficulty she was experiencing getting a good reading from Patient O.C., both of the fetal heartbeat rate and Patient O.C.'s contractions. At 1:02 a.m., Dr. Alvarado was called to attend to another patient. (Admitted Facts). At 1:12 a.m., Patient O.C. was placed back on an external fetal heart monitor. (Admitted Facts). At 1:50 a.m., Dr. Alvarado returned and examined Patient O.C. (Admitted Facts). Nurse Wimberly discussed with Dr. Alvarado the difficulty she was experiencing attempting to monitor the baby's fetal heartbeat rate with an external monitor. Dr. Alvarado agreed that an internal monitor was necessary. Dr. Alvarado artificially ruptured Patient O.C.'s, membrane to place the fetal scalp electrode and intrauterine monitor.13 (Admitted Facts). Although Patient O.C. was not in labor when he ruptured her membrane, Dr. Alvarado's plan was to induce labor at 6:00 a.m. if Patient O.C. did not go into active labor by then. (Admitted Facts). When Dr. Alvarado ruptured Patient O.C.'s membrane, meconium-stained amniotic fluid was noted. (Admitted Facts). Meconium is a bowel movement which occurs in the amniotic sac. The presence of meconium in the amniotic fluid is an indicator that there may be some stress on the part of the fetus. According to Dr. Danna, the presence of meconium: does not necessarily mean you have to rush the patient to the operating room and do a deliver. It depends on how the fetal monitoring strip looks, but it could indicate some stress and your awareness has to be heightened that this is a high risk labor and you need to pay attention to the fetal monitoring strip for evidence of hypoxia. There is also risks of meconium aspiration where the baby aspirates the meconium into the lungs and that could be very serious. Transcript, Volume I, Page 139, Lines 22-25, and Page 140, Lines 1-4. Although there was meconium present, the evidence in this case failed to prove the extent to which its presence was an indication that Patient O.C.'s fetus was in distress at the time Patient O.C.'s membrane was ruptured. The evidence also failed to prove when the bowel movement which the meconium evidenced took place. Dr. Alvarado had, prior to rupturing Patient O.C.'s membrane, performed a vaginal examination and found her to be two and a-half centimeters dilated and to have progressed from thick to 80 percent thinned out. Dr. Alvarado placed an electrode on the baby's scalp to monitor the baby's heart rate and an intrauterine pressure catheter in Patient O.C. to monitor Patient O.C.'s contractions. (Admitted Facts). The intrauterine pressure catheter placement was completed at approximately 2:00 a.m. From that time on, the fetal heart rate monitoring strips were more precise. At 2:15 a.m. Patient O.C. was experiencing contractions every one to three minutes for 60 seconds and the fetal heart rate was 150 to 160. (Admitted Facts). Dr. Alvarado, once the internal fetal heart monitor and the intrauterine pressure catheter were placed, only reviewed the resulting fetal heart monitor strip for approximately 15 minutes. He did so, despite his testimony at hearing that the strip should be monitored for at least an hour. Dr. Alvarado was asked the following questions and gave the following responses in this regard: Q. Okay. Why did you ask them to continue monitoring her? A. Well, you cannot make a judgment with ten-minute tracings. Every patient that goes to the hospital -- even with no concern, nor risk factor, or anything like - - will be monitored for at least one hour. She just arrived. She had only about ten minutes by the time that the nurse got to her and put the monitor on. It was only about ten or fifteen minutes. We needed to know a little bit longer what was going on. Transcript, Volume II, Page 229, Lines 14-23. While this testimony dealt with the initial external monitoring of Patient O.C., the facts in this case proved that, because the initial monitoring of Patient O.C. was problematic and to a large extent unreassuring, and given the fact that she was a high-risk patient, Dr. Alvarado was in error when he assumed that he already had sufficient data to leave Patient O.C. after only approximately 15 minutes of data from the internal monitoring. Dr. Alvarado returned to the Leesburg Regional emergency room at 2:15 a.m. to attend to patients and subsequently left for his home, which is located less than five minutes from the hospital. (Admitted Facts). After Dr. Alvarado left Patient O.C., Nurse Wimberly continued to monitor the fetal heart rate strip. The fetal heart rate continued to be generally the same evidenced by the external monitoring strips. At 2:22 a.m., the baby's fetal heart rate dropped into the 90's for 60 seconds, before returning to the base line. (Admitted Facts). Dr. Alvarado was not notified of this drop. (Admitted Facts). At 2:30 a.m. Patient O.C. complained of pain and Dr. Alvarado was notified. (Admitted Facts). At 2:43 a.m., the fetal heart rate exhibited a clear late deceleration, dropping for approximately 40 seconds. (Admitted Facts). Dr. Alvarado was notified. (Admitted Facts). Nurse Wimberly recognized the decelerations and initiated routine interventions but failed to notify Dr. Alvarado. (Admitted Facts). Between 3:58 a.m. and 4:15 a.m., the chart shows several more fetal heart monitor late decelerations and nurse "fails to notify" Dr. Alvarado of any. (Admitted Facts). The following, while of little relevance, are included in this Recommended Order because they are "Admitted Facts": At 4:20 a.m. Nurse Wimberly left Dr. Alvarado a message on his home phone answering machine that Dr. Hanubal was coming to the Leesburg Memorial to deliver Patient O.C.'s baby.14 Dr. Alvarado was not notified of Patient O.C.'s request that Dr. Hanubal deliver the baby. The nurse informed Dr. Hanubal about the decelerations and he ordered an emergency cesarean section, which was performed at approximately 4:50 a.m. The chart reflects the baby was pronounced dead at 6:40 a.m. Dr. Alvarado does not know what resuscitation efforts were undertaken. Dr. Alvarado arrived in a labor room at 7:00 a.m. for a cesarean, and was surprised with the news and fact that he was never notified. A cesarean is the surgical delivery of an infant through an incision in the mother's abdomen and uterus. The Administrative Complaint. On July 19, 2005, the Department filed an Administrative Complaint in which it alleged that Dr. Alvarado, in his treatment of Patient O.C., had violated Section 458.331(1)(t), Florida Statutes, which requires that a physician practice medicine with "that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances . . . ." (hereinafter referred to as the "Standard of Care"). In paragraph 26 of the Administrative Complaint, it has been alleged that Dr. Alvarado violated the Standard of Care by one or more of the following: Failing to accurately diagnose Patient O.C.'s condition; Failing to remain in the hospital after initiating labor by rupturing Patient O.C.'s membranes; Failing to accurately diagnose fetal heart distress; Failing to accurately diagnose [the] risk to [the] fetus when meconium fluid was noted upon rupture of membranes. While Dr. Alvarado has raised an issue as to whether the Administrative Complaint is constitutionally vague, an issue which this forum has no jurisdiction to address,15 he did not request a more definite statement from the Department during this proceeding. Dr. Alvarado's Violation of the Standard of Care. Dr. Alvarado's treatment and care of Patient O.C. as described in this Recommended Order and based upon the credited opinion of Dr. Danna, violated the Standard of Care as alleged in paragraphs 26(a) and (b) of the Administrative Complaint. The evidence failed to prove that Dr. Alvarado's treatment and care of Patient O.C. violated the Standard of Care as alleged in paragraphs 26(c) and (d) of the Administrative Complaint. As to Dr. Alvarado's diagnosis of Patient O.C., in most respects his diagnosis was within the Standard of Care. His Proposed Findings of Facts and Conclusions of Law, paragraphs A1 through A4 accurately describe incidents where his diagnosis of Patient O.C. was adequate. Where Dr. Alvarado violated the Standard of Care is when he failed to adequately reevaluate her condition through the results of the internal fetal heart monitor and the intrauterine pressure catheter. As explained by Dr. Danna, Dr. Alvarado violated the Standard: A. Because of the strip or her fetal heart monitor continued to deteriorate and there was no resolution of her late decelerations. Once he monitored her using the fetal scalp IUPC [intrauterine pressure catheter], it should have been re-evaluated by him soon after that to see if those late decelerations revolved [sic]. Q. How soon after he had applied the IUPC should she have been re-evaluated? A. At least within thirty minutes to an hour. Do you believe that to be the standard of practice with respect to obstetrical patients at this point? A. Yes. Transcript, Volume I, Page 162, Lines 15 through 25. She also stated the following in this regard: I believe that a reasonable physician would have re-evaluated the strip once the internal leads were placed, the scalp lead and the intrauterine pressure catheter, and re-evaluated the strip to see if these issues of non-reassuring surveillance resolved and if they didn't resolve then a cesarean section should have been ordered, especially, since she was remote from delivery. Transcript, Volume I, Page 160, Lines 16 through 22. Dr. Alvarado also failed to meet the Standard of Care when he left Leesburg Memorial as soon after rupturing Patient O.C.'s membrane as he did. This violation is predicated on the same error committed by Dr. Alvarado, which is the basis of his violation of the Standard of Care in his failure to properly diagnose Patient O.C.'s condition. Again, Dr. Alvarado's violated the Standard of Care when he went home from the hospital because he failed to adequately monitor the fetal heart monitoring strip for an adequate period of time after the internal heart monitor was initiated before he did so. Dr. Alvarado's position on this issue misses the mark. Dr. Alvarado has argued that there was no testimony from any expert that a doctor must remain at a hospital after initiating labor by rupturing a patient's membranes. Dr. Alvarado also argued that it is acceptable for a physician to rely upon a trained obstetrical nurse who can notify him of a patient's condition. While these arguments are correct, Dr. Alvarado failed to establish that it was within the Standard of Care to leave a patient in Patient O.C.'s condition without first obtaining adequate fetal heart monitoring data and data from the intrauterine pressure catheter. The evidence failed to prove that Dr. Alvarado violated the Standard of Care by failing to diagnose fetal heart distress. The evidence failed to prove clearly and convincingly that Patient O.C.'s fetus suffered fetal heart distress. Finally, Dr. Alvarado did not violate the Standard of Care by failing to accurately diagnose the risk to Patient O.C.'s baby when he noted meconium fluid upon rupture of Patient O.C.'s membranes. Even the Department's expert agreed. Dr. Danna, when asked whether Dr. Alvarado violated the Standard of Care when he failed "to accurately diagnose the risk to the fetus when meconium fluid was noted upon the rupture of those membranes" answered as follows: "I don’t think that is -- no, I don't think that is the case." Transcript, Volume 1, Page 163, Lines 15 and 16.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Manuel Alvarado, M.D., has violated Section 458.331(1)(t), Florida Statutes, as described in this Recommended Order; issuing him a letter of concern; requiring that he pay an administrative fine of $5,000.00; placing his license to practice medicine on probation for two years; and requiring that he attend continuing education classes in an amount and of a nature to be determined by the Board. DONE AND ENTERED this 9th day of June, 2006, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2006.
Findings Of Fact Respondent is a licensed chiropractor in the State of Florida and was so licensed at the time of the alleged violations. He holds License No 2167 issued by the State Board of Chiropractic Examiners. On December 24, 1975, pursuant to a request of Randy Spector for a blood test, Respondent extracted a blood sample from Spector. At this time, Respondent informed Spector that he would send the blood sample to MET-PATH laboratories for testing and that the results would be back in approximately a week or ten days. A few days later Spector visited Respondent's office and was informed by him that the tests were fine and that he was in good health, but he did not have the results back from the laboratory. Respondent's wife, who was present, told Spector that the laboratories do not always send the test back unless they are asked for or unless something was wrong. This sounded like "double talk" to Spector and he asked Respondent for the test results. Respondent said that he would call the lab on the phone and obtain the results. On January 2, 1976, Spector again visited Respondent's office and was provided the report of blood analysis. Respondent explained some of the entries on the report and after so doing, Spector asked him to sign the report. Respondent did so. Thereupon Spector gave him a check for $15.00 in payment for the test and was provided a receipt. (Testimony of Spector, Petitioner's Exhibits 1,2 & 3) Spector was now convinced that the analysis of his blood had not been made by MET-PATH laboratories and therefore called that company several times during the next week or so. Each time he was informed by that concern that they had not received any of his blood for testing from Respondent. On January 5, 1976, Spector's legal counsel wrote a letter to Respondent advising him that Spector believed that the test results were fabricated and asserted a claim for malpractice and fraud. Respondent's counsel responded by letter of January 19 denying the allegations and stating that "if there was any error, it was simply an error in transposition of any test results and there was no resulting damage of any nature whatsoever to your client". (Testimony of Spector, Respondent's Exhibits 1 & 2). Spector contacted Dr. George Fica, a chiropractor who had been treating him and his wife. He told him of his complaint against Respondent and indicated that the matter was going "to be blown sky high" and that the press would be involved. However, Spector told Fica that if Respondent apologized, he would drop the matter. He showed Fica the blood test results and Fica told him that they were in normal limits but that some of the tests would have required the use of a laboratory. Fica talked to the Respondent about Spector's complaints and his claim that MET-PATH Laboratories had not done the work. Respondent stated that he had done it with a machine in his office. Fica then questioned him about certain tests such as triglycerides, which required laboratory analysis. Respondent then informed him that he didn't do the work in his office, but that he was using many labs for blood work and that his secretary had typed the wrong information on Spector's report. (Testimony of Fica) About January 12th or 13th, Spector went to Respondent's office and told him that the matter had gotten out of hand and that he wanted to straighten it out. Spector checked Respondent's tape recorder to make sure it was not running and also looked up and down the hallway outside his office and then closed the door. During the course of the conversation, Respondent apologized for not sending Spector's blood sample to MET-PATH and told him that he had run the tests in his own office and that they had been transposed in error. Spector told Respondent it would cost him a lot of money to go to court and indicated that the matter should be settled. (Testimony of Spector; Respondent) It was stipulated that Respondent had not sent Spector's blood sample to any laboratory for analysis. Respondent testified that he had originally planned to send Spector's blood to MET-PATH but due to a previous fire that destroyed much of his office, he had no usable mailing cartons for this purpose. Therefore, he did those tests that he could perform on a machine in his office. A number of the tests could not be done on the machine and he was unaware that his secretary had typed entries for such tests on the report given to Spector. Respondent speculated that the secretary must have mistakenly used figures from another patient's blood test when preparing the report. This explanation is not deemed credible in view of Respondent's contradictory statements in this regard to Spector and Fica as set forth in the foregoing findings. The laboratory cost for preparing a blood analysis is approximately $10.00. (Testimony of Resp., Pet.'s Exh. 4) Respondent has been a chiropractor for approximately 13 years and enjoys an excellent reputation for competence in his field. An associate, who has been in his office for the past several months, has never observed him engage in an unethical practice. (Testimony of Respondent, Fica, Gordon)
Recommendation That the Florida Board of Chiropractic Examiners issue a reprimand to Respondent, R.H. Grant, for violation of Section 460.13(3)(h), Florida Statutes. DONE and ENTERED this 25th day of October, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Ronald C. LaFace, Esquire Post Office Box 1752 Tallahassee, Florida Charles A. Sullivan 1245 20th Street Post Office Box 3 Vero Beach, Florida 32960
The Issue The issue presented in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on August 17, 1999.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine, pursuant to Section 20.43, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. Pursuant to the provisions of Section 20.43, Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils, or boards. Respondent is a licensed physician in the State of Florida, having been issued license number ME 0063067. Respondent is board-certified in internal medicine. On March 10, 1995, Patient C.C., a 68-year-old woman with a history of cigarette smoking first presented to Respondent as a new patient with a complaint of nocturia (frequent urination at night). Patient C.C. completed a medical history form for Respondent indicating her past medical history and any medical complaints that she had at that time. Patient C.C.'s history was negative, with the exception of treatment for a skin disorder and arthritis of the fingers. Patient C.C. reported no history of cardiorespiratory problems and had no complaints of cardiorespiratory problems. Patient C.C. had undergone laboratory testing on March 8, 1995, that revealed an elevated glucose level of 167. While the blood glucose level was elevated, Patient C.C. did not meet the specific diagnosis criteria, as it existed in 1995, to be diagnosed as a diabetic. Respondent conducted a physical examination of Patient C.C., noting his findings in Patient C.C.'s chart. Due to the elevated glucose level, Respondent directed Patient C.C. to begin a 1500 calorie diet and follow an exercise regimen. Respondent advised Patient C.C. of his evaluation, assessment, and proposed plan of treatment. While in his care, Respondent regularly ordered laboratory testing to monitor Patient C.C.'s glucose levels. A report dated May 13, 1995, revealed that Patient C.C.'s glucose level had decreased to 136. A report dated September 7, 1995, revealed Patient C.C.'s glucose level to be 128. Laboratory testing performed at Community Hospital of New Port Richey on October 17 and 18, 1995, revealed glucose levels of 135 and 133, respectively. Upon receipt of the laboratory findings and pertinent diagnostic testing, Respondent advised Patient C.C. of the results, discussed his recommended course of treatment, and noted the discussion in her medical record. On October 16, 1995, Patient C.C. presented to Respondent suffering from uncontrolled hypertension, anxiety, stress, and non-specific chest discomfort. Respondent immediately admitted Patient C.C. into Community Hospital of New Port Richey. Patient C.C. underwent a chest X-ray during her hospitalization. The X-ray revealed a right upper lobe consolidation and the radiologist's report urged follow-up. Respondent received the radiologist's report and discussed the findings with Patient C.C. On October 24, 1995, Respondent advised Patient C.C. by certified letter that he would no longer provide medical care for Patient C.C., that her condition required medical attention, and that she should seek the care of another physician without delay. Patient C.C. received the certified letter on October 27, 1995. Respondent never had the opportunity to provide follow-up or additional care to Patent C.C. as related to the abnormal chest X-ray or elevated glucose level. The evidence at the hearing established that the care provided to Patient C.C. by Respondent was within the standard of care. The evidence at hearing also established that the Respondent's medical records for Patient C.C. documented and justified the course and scope of his treatment of Patient C.C. Respondent's expert testified that the standard of care did not require Respondent to obtain a chest X-ray when he initially saw Patient C.C. in March 1995. Petitioner's expert offered no testimony and presented no evidence on this issue. Practice guidelines did not require and, in fact, recommended against obtaining routine chest X-rays to screen for lung cancer, even for patients at risk, such as smokers. Respondent and the Respondent's expert, Dr. Corral, both testified that Patient C.C. was not a diabetic, and therefore, did not require treatment for a condition from which she did not suffer. Petitioner's expert, Dr. Benson, testified that Patient C.C. was a diabetic and required definitive treatment for that specific condition. Dr. Benson's testimony is less credible on this issue, and the testimony of Respondent and Dr. Corral is found to be more persuasive and credible. Patient C.C. did not meet the 1995 criteria to be diagnosed as a diabetic. The clear and unambiguous criteria required elevation of plasma glucose greater than 200 mg/dl, or a feasting plasma glucose greater than 140 mg/dl on two consecutive occasions. Patient C.C. never met the criteria. Respondent adhered to the standard of care in diagnosing, evaluating, monitoring, and treating Patient C.C.'s elevated glucose levels. In summary, Petitioner failed to establish by clear and convincing evidence that Respondent failed to meet the standard of care with regard to his alleged failure to (1) perform a complete history and physical examination on a new patient with significant risk factors for cardiopulmonary disease; (2) to order a chest X-ray as part of a work-up on a new elderly patient with a long history of smoking; (3) follow up on the patient's abnormal chest X-ray; and (4) follow up with the patient's test results that revealed an elevated glucose level. Additionally, Petitioner failed to establish by clear and convincing evidence that Respondent did not keep written medical records justifying the course of treatment of the patient by failing to document a plan or evaluation for the course of treatment of Patient C.C.'s abnormal chest X-ray and elevated plasma glucose level.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Department of Health, Board of Medicine, enter a final order dismissing the August 17, 1999, Administrative Complaint against Respondent, Rajesh Bhagvatipras Dave, M.D. DONE AND ENTERED this 6th day of March, 2001, in Tallahassee, Leon County, Florida. WILLIAM R. PFEIFFER 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 6th day of March, 2001. COPIES FURNISHED: Christopher J. Schulte, Esquire Burton, Schulte, Weekley, Hoeler, Poe & Robbins, P.A. 100 West Kennedy Boulevard Suite 800 Tampa, Florida 33602 Eric Scott, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 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
Findings Of Fact Valaria Alsina has been licensed as a medical physician in Florida since 1976 and was so licensed at all times here relevant. On August 19, 1980, Elsa Trujillo and her daughter Nancy, age 12, visited the office of Respondent for treatment. This was the initial visit to Respondent by these patients. Patient histories in Exhibit 3 for Elsa show the first entry to be October 7, 1980; however, the language used in this history clearly shows this to be not Elsa's first visit. Respondent's testimony and reports submitted by Respondent to Petitioner, Exhibit 3, reveal initial complaints by this patient to be dizziness, urinary tract infection, vomiting, vaginal discharge, headache, depression, burning sensation while voiding, and dark urine. Respondent did a urinalysis, took blood for testing, did a PAP smear and vaginal irrigation. Other treatment rendered this patient was not disclosed. The skin and blood tests performed constitute the gravamen of the charges here involved. In Exhibit 1 Respondent billed the insurance carrier for Elsa $359.50 for this visit of August 19, 1980. Those blood tests, the necessity for some of which is questioned by Petitioner, are for glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including sodium, potassium, chlorides, and carbon dioxide) total protein, bilirubin, and albumin. The reason the need for these tests is questioned is because they were billed to Prudential Insurance Company as individual tests for each of which Respondent billed from $10.00 to $20.00. These tests are normally performed by medical laboratories in groups, automatically, in which testing machines are programmed to do certain tests on one blood sample introduced into the testing machine. These automatic testing procedures are generically designated "SMA" and are known as SMAC-6, SMAC-16, SMAC-26, etc., with the number denoting the number of tests performed. Those blood tests performed on the Trujillos are all included in the SMAC-22 program for which a laboratory normally charges the doctor $10-$12. Had these tests been charged as SMAC-22, the fact that several were unnecessary would have been accepted because, as a SMAC-22 neither physical nor financial harm resulted to the patient from the unnecessary blood tests conducted. The SMAC-22 could have been performed as cheaply as or cheaper than two manual and individual tests. Since Petitioner's expert witnesses both agreed that some of the tests conducted on this patient were indicated from the symptoms presented, the only fault they found was in Respondent's performing, and charging the patient for, individual and manual blood tests for which there was no medical justification. Nancy Trujillo was seen by Respondent on August 19, 1980. For this visit Respondent billed Prudential Insurance Company $262.50. Clinical data prepared by Respondent for Nancy shows usual childhood diseases, tonsillectomy, adenoid-ectomy, fever, sore throat accompanied by ear pains and swelling, patient complaining of weakness, history of anemia, poor appetite, burning sensation when voiding, dark urine, and a skin rash on right leg. Patient's weight was recorded as 70 pounds, but neither height nor temperature was recorded. In addition to a complete physical examination, a urinalysis, skin culture, and sensitivity test were done, and blood chemistry tests included complete blood count, calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. These blood tests, all of which (except the cbc) are included in a SMAC-22, were billed as having been performed as individual tests at costs ranging from $10.00 to $17.50 each. Treatment prescribed for Nancy consisted of aspirin suppositories. Respondent testified that Nancy was under weight, although her height was not measured, and that she took Nancy's temperature but failed to record it. Jose Trujillo was seen by Respondent on February 4, 1981, as a patient. Clinical data recorded by Respondent on this visit (Exhibit 3) include ". . . history of diverticulitis of colon, states that have diet but feels like some abdominal discomfort accompanied by diarrhea and feels weak. Patient with history of admission in the hospital, admission Palmetto General Hospital. Some lower discomfort abdomen and dark urine." For this visit prudential Insurance Company was billed $340 for complete physical examination (genital exam omitted) complete blood count; urinalysis; blood tests including glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including calcium, potassium, chlorides, and carbon dioxide) total protein, cholesterol, triglycerides, SGOT, SGPT, and alkaline phosphates; urine culture; sensitivity test; and collection and handling. The blood tests were all included in a SMAC- 22 but were billed as individual and manually performed tests with costs ranging from $10.00 to $20.00 each. Petitioner's expert witnesses both testified that some of the tests performed on these three patients were indicated by the symptoms and complaints described. Other tests conducted were not appropriate for the symptoms given. They also agreed that had these tests been conducted and billed as a SMAC-22 they would not consider that that could be a violation of the Medical Practices Act because, even though some of these tests were not medically indicated, they "come with the package" and would not increase the cost to the patient. However, when conducted manually and individually and so billed, the practice of conducting blood tests for which there is no medical justification does not conform to the generally prevailing standards in the medical community. Because of the findings below, it is unnecessary to denote those tests performed on each of the Trujillos for which there was no medical justification. Although billed to Prudential Insurance Company as manually and individually performed, the blood tests on the three patients above-named were conducted as a SMAC-22 and were not performed manually and individually as testified to by Respondent. This determination is based on the following facts, circumstances, and rationalizations: Respondent sent the blood samples from these three patients to Central Medical Laboratory, Inc., for a SMAC-22 test. Respondent testified that she performed each of the series of 10 to 15 tests on the blood samples of these patients in 20 to 30 minutes; however, other medical witnesses testified it took a trained technician 20 minutes to perform one of these blood tests manually. The latter testimony is deemed more credible. Many of these tests have subjective characteristics, such as color comparisons, and identical results from the same blood sample tested by two technicians or run through the same automated process would be rare. The odds against a technician performing individual and manual tests on 16 blood samples and obtaining the identical result on all tests that is obtained from a commercial laboratory SMA test is astronomical. Yet, the one report obtained from Central Medical Laboratory for the SMAC-22 conducted on the blood sample from Jose Trujillo (Exhibit 7) is identical to the "manual and individual" test report maintained by Respondent for the same blood sample in Exhibit 3--with one exception. The laboratory found the triglyceride test to be 254 MG/DL, well outside the 30-175 range for this test. On Exhibit 3 Respondent recorded 175 for this test. She testified she sent blood samples from the three Trujillos to the laboratory to have a check on her tests but did not ask the laboratory to do a recheck on the triglycerides test on Jose or recheck her test for triglycerides after receiving the laboratory report. Only a small amount of blood (5 or 10 cc) is required for an automated procedure for up to 40 different tests, whereas at least three times this amount of serum would be required for 10 tests conducted manually or individually. Accordingly, manual testing would require the drawing of a lot more blood than would be required for automated testing in a commercial lab. Respondent testified that she sent one-half of the blood sample taken on each Trujillo to the laboratory and kept the other one-half to test in her office. Commercial medical laboratories are licensed by the state; are checked for compliance with proper procedures; equipment used is checked for proper calibration at frequent intervals; reagents used in the testing is frequently replaced; and, when compared to the equipment, procedures, calibration, and reagents used in a physician's office which are subject to no regulation, the former should provide the more reliable test in a much shorter time. The equipment in Respondent's office is capable of being used to conduct all of the tests on these three patients for which Respondent billed Prudential Insurance Company. No rational explanation was provided to justify having a SMAC-22 performed and duplicating these tests manually. Respondent's testimony that the SMAC-22 was ordered to check the results of the manual tests she performed is not credible. If a check on the manual tests conducted on blood samples of Nancy and Elsa Trujillo for the August 17, 1980, visit was desired, it would appear appropriate to check the office procedures by doing a SMAC-22 on only one of those blood samples, rather than have both of these samples checked as was done here. Repeating this "check" on the sample taken from Jose Trujillo on February 4, 1981, does not make sense. Either the laboratory test is trusted or it is not. The same applies to the individual tests conducted manually in the office. If confident of the procedures, there would be no reason for Respondent to check the manual tests conducted in the office by sending one-half of the serum to a commercial laboratory. Respondent testified that Central Medical Laboratory picks up blood samples at her office daily. This suggests that some tests are routinely ordered by Respondent and conducted by the laboratory, and no evidence was presented to rebut such a conclusion. On the other hand, Petitioner presented no evidence of the volume of tests conducted by Central Medical Laboratory for Respondent which would solidify this conclusion. Nor did Petitioner submit the SMAC-22 results obtained by Central Medical Laboratory for the blood test conducted on the serum taken from Elsa and Nancy Trujillo on August 17, 1980, to see if they too were identical to the results shown in Exhibit 3. The only rational explanation for having SMAC-22 tests performed in a commercial laboratory and reporting these tests as done individually and manually in Respondent's office is the amount the insurance company will pay for the latter is nearly ten times what they will pay for the former. Laboratory tests billed for Jose Trujillo for the February 4, 1981, visit amount to nearly $250. Charges submitted for these tests reported on the SMAC-22 (Exhibit 7) amount to $187. Respondent testified she paid for the SMAC-22 tests she ordered and did not bill the insurance company for these tests because "they won't pay for both" SMAC and manual tests performed on the same sample. Since the lab charged Respondent only $10-$12 for the SMAC-22 tests conducted, the insurance company would not pay $187 if these tests were charged as automated tests. Considerable evidence was submitted that there was no medical justification for certain of the tests performed on Nancy, Elsa, and Jose Trujillo. For Nancy, these unnecessary tests included tests for calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. For Elsa, these unnecessary tests were calcium, phosphorus, uric acid, total protein, bilirubin, with either BUN or creatinine justified, but not both. For Jose, no medical justification was shown for manually performed tests for glucose, calcium, phosphorus, electrolytes, SGDT and SGNT. In view of the finding above, that these tests were not manually done but were performed as a SMAC-22, the fact that they are not medically justified if done manually becomes immaterial.
