Findings Of Fact The Respondent, Stephen L. Watson, M.D., has been practicing medicine in Lakeland, Florida, since 1945. Since 1950, he has been board-certified in obstetrics and gynecology. Until this case, he has not been the subject of any Board of Medicine disciplinary proceeding. He recently closed his practice of medicine due to his own poor health. The Respondent saw B. D., as a gynecology patient, for the first time in December, 1983. She was 33 years old at the time and was obese, weighing 184 pounds and standing only approximately five feet, four inches. She also had borderline high blood pressure, at 140/90. On the patient's second visit in July, 1984, the Respondent discussed her weight and gave her a book on diet and weight loss entitled, "The Lighter Side of Life, the Doctor's Program that Really Works." He discussed the contents of the book with her, emphasizing certain parts of it. He also prescribed a month's supply of an appetite suppressant called Fastin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next visit was a weight conference on January 2, 1987. On this visit the patient weighed 212; her blood pressure was 140/90. The Respondent again discussed weight and diet with the patient and prescribed a month's supply of another appetite suppressant called Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Didrex contains the anorectic agent benzphetamine hydrochloride. It is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Didrex is contraindicated in patients with moderate to severe hypertension, and caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. At the visit on January 2, 1987, it also was arranged that the Respondent would have blood work done on January 6, a pelvic examination on January 7, and another weight conference on January 29, 1987. As often would happen during the long doctor-patient relationship, the patient missed all three appointments and did not request a refill of her medications. The patient's next visit was for another weight conference on February 10, 1987. She had lost 12 pounds (down to 200), and her blood pressure reading was down to 130/88. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Ten days later, the patient came in complaining of "nerves" after taking her medications. The Respondent discontinued the Didrex and the diuretic and scheduled the patient for another weight conference for March 10, 1987. The patient missed the March 10, 1987, appointment as well as the next two rescheduled appointments, and she did not request a refill of her medications. Finally, the patient kept the third rescheduled appointment for a weight conference, for May 6, 1987. By this time, the patient's weight was back up to 208. Her blood pressure reading was 120/80. The Respondent prescribed a month's supply of another appetite suppressant called Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her weight conference scheduled for June 3, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for June 11, 1987. This time, her weight was back down, to 197, and her blood pressure reading was 120/80. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient again missed her next scheduled weight conference, for July 9, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for July 13, 1987. This time, her weight was down further, to 187, and her blood pressure reading again was 120/80. The Respondent's course of treatment continued to seem to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next weight conference was on August 17, 1987. Her weight was down a little more, to 183.5, and her blood pressure reading remained at 120/80. The Respondent's course of treatment continued to seem to be effective, although the patient's rate of weight loss was decreasing. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic apparently due to a bladder problem. The patient missed her next scheduled weight conference, for September 15, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on October 9, 1987. Her weight was up a little, to 184.75. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for November 6, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on December 7, 1987. Her weight was down a little, to 183. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for January 5, 1988, and did not request a refill of her medications. The patient's next rescheduled weight conference was on February 18, 1988. Her weight was up a little, to 187.5. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of another appetite suppressant called Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. Tenuate Dospan contains the anorectic agent diethylpropion hydrochloride. Like Didrex, it is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. It is contraindicated in patients with severe hypertension, and caution is to be exercised in prescribing it for any patient with hypertension. The Respondent did not see the patient again for weight control, or prescribe any more medication, until May 3, 1988, when the patient was seen for bladder problems. Her weight was down a little, to 181.5, and her blood pressure reading was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic again apparently due to a bladder problem. The patient preferred Tenuate Dospan, and the Respondent changed the prescription to another month's supply of Tenuate Dospan. The patient missed the next two conferences, scheduled for August 8 and rescheduled for August 9, 1988, and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a weight conference on December 2, 1988. Her weight was up a little, to 185. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next four scheduled appointments and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a blood pressure conference on June 28, 1989. Her weight was up significantly, to 200, and her blood pressure reading was up significantly, to 140/100. Although the patient still was relatively young (approximatly 39), and the Respondent believed there was a causal connection between the patient's weight and blood pressure, the Respondent prescribed only a month's supply of Enduron, a medication for hypertension. The patient missed her next two scheduled blood pressure conferences and did not request a refill of her blood pressure medications, or request any other medications. She did not see the Respondent or get any more medications from him until she saw him for blood in the urine on October 3, 1989, and had a urinalysis and conference. At the time, her weight was up a little more, to 203, and her blood pressure reading was 140/90. The Respondent prescribed an antibiotic and, for reasons not apparent from the evidence, a month's supply of a mild antidepressant, called Elavil. On or about October 23, 1989, the patient telephoned for a refill of her Enduron prescription, which was about to run out, and the Respondent prescribed another month's supply. The patient again missed her next weight conference scheduled for October 30, 1989, and did not request any other medications. She did not see the Respondent or get any more medications from him until a rescheduled weight conference on December 11, 1989. By this time her weight was up to 217, and her blood pressure reading was 140/98. The Respondent was aware that amphetamine-like appetite suppressants should be used with caution with patients having moderately high blood pressure, as the patient had by December 11, 1989. But he also continued to believe that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. He prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (Tenuate is essentially the same drug as Tenuate Dospan but is shorter lasting.) On January 5, 1990, the patient telephoned the Respondent with a complaint of "nerves." The Respondent prescribed another month's supply of Elavil, with authority for two refills. The patient's next weight conference was on January 24, 1990. Her weight was up a little more, to 220, and her blood pressure reading was 160/98. At that point, it seemed that perhaps the Tenuate Dospan was not effective. Although there could be other explanations why the patient was not losing weight, and it was possible that all appetite suppressants had become ineffective, the Respondent decided to switch the patient to Didrex, which seemed to have been effective in the past, and prescribed a month's supply, to be taken in conjunction with the diet recommendations, along with a diuretic. He also changed her blood pressure medication to Wytensin. The patient missed her next weight conference, scheduled for January 31, 1990, and did not request any additional medications. The patient did not see the Respondent again, or get any additional medications from him, until March 21, 1990, when she saw him to get a letter for employment purposes certifying that she was disease-free. Her weight was up to 226, and her blood pressure was 164/96. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic and another month's supply of Wytensin. The patient did not see the Respondent again, or get any additional medications from him until August 28, 1991, when she saw him to complain of blood in the urine. At this time, her weight was 234, and her blood pressure reading was 140/90. In addition to treating the urine problem, the Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic and a month's supply of Wytensin. The patient missed her appointment for a pelvic examination on September 5, 1991, and did not see the Respondent, or get any additional medications from him until she went to a weight conference on December 11, 1989. Her weight was 234.5, and her blood pressure reading was 140/94. The Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (It is not clear from the evidence why no blood pressure medication was prescribed.) The patient missed her appointment for a pelvic exam on December 17, 1991, and missed scheduled weight conferences for February 10, 11, and 19, 1992. She did not request any additional medications during this time. The patient made her next scheduled appointment on March 16, 1992, when the Respondent discussed her weight, blood pressure and complaint of headaches. Both her weight and her blood pressure were at their highest: weight, 237; blood pressure reading, 150/110. At this point, there was a real question whether the appetite suppressants still were effective in controlling the patient's weight and thereby helping reduce the patient's blood pressure. On the other hand, the patient continued to miss weight conferences and not follow through on the Respondent's instructions, and it was not clear whether the patient ever had followed the Respondent's weight control treatment long enough to give it a fair chance to work. The patient's blood pressure now was moderately to severely high; on the other hand, she still was only about 42 years of age, and her weight still could have been contributing to her high blood pressure. Nonetheless, the Respondent decided to prescribe only Wytensin on March 16; he also scheduled a complete physical for March 20, 1992. On March 20, 1992, the Respondent had the patient undergo a complete physical. Her weight still was 237, and her blood pressure reading was 160/120. He switched her blood pressure medication to Accupril and decided not to prescribe any appetite suppressants at that time. He scheduled the patient for a weight conference on April 3, 1992. On April 3, 1992, the patient's weight still was 237, but her blood pressure reading was 150/110. Although the patient's blood pressure still was moderately to severely high, the Respondent decided to try an appetite suppressant to reduce her weight in the hopes of, together with the blood pressure medication, effecting a lasting reduction in her blood pressure. He prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. On April 14, 1992, the patient telephoned the Respondent to report that her blood pressure still was up and that she continued to suffer from headaches. The Respondent decided that it was time to refer the patient to a specialist in internal medicine and made an appointment for her. The patient missed her next scheduled weight conference on April 16, 1992, and missed the appointment with the internist which the Respondent had scheduled for her. She never saw the internist. The patient's next appointment was on May 6, 1992. The Respondent discussed the patient's weight and her hypertension. Her weight was 236, and her blood pressure reading was down to 144/100. The Respondent decided to prescribe a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient overdosed on a pain medication (not the appetite suppressant) and was hospitalized on June 4, 1992. She missed the next scheduled weight conference on June 15, 1992. She did not request any additional medications. The patient's next appointment with the Respondent was on June 18, 1992. She weighed 230, and her blood pressure reading was 140/110. The Respondent prescribed only Accupril and an iron supplement. The Respondent only saw the patient once more, on July 17, 1992, for gynecological problems, and referred the patient to a specialist. He did not prescribe any medications. The patient's blood pressure was 130/100. Her weight was not recorded. The evidence does not reflect that the patient, B. D., grew progressively dependent on the appetite suppressants the Respondent prescribed for her. There was no evidence that the patient ever asked for a refill or new prescription early. She often missed scheduled appointments, resulting in gaps of time between prescriptions when the patient presumably had no appetite suppressants available to her. There also were extended periods of time between visits during which time the patient presumably had no appetite suppressants available to her. Some reputable physicians now seriously question the use of appetite suppressants. There is some evidence that patients lose as much weight and maintain as much weight loss without them as with them. The trend in the late 1980s and early 1990s has been to treat patients for obesity with behavior modification (essentially, diet and exercise) only. But there is no evidence that it is below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances to treat patients for obesity by prescribing appetite suppressants in conjunction with diet recommendations. It is true that the Respondent prescribed appetite suppressants for longer periods of time than recommended in the medical and pharmaceutical literature. The literature recommends using appetite suppressants only during the early weeks of a weight reduction program. The reasons are twofold and related: first, the patient generally builds a tolerance to the appetite suppressant, making them less effective; second, the patient can become dependent on them. The goal is to use appetite suppressants to begin reducing caloric intake for initial weight loss, while changing eating habits for long term reduction in caloric intake and weight. The problem confronting the Respondent in this case lay in the nature of the patient's noncompliance. She would begin the program but not follow it or continue with it for long. When she returned to the Respondent after a long hiatus, it was like starting the program over again. The evidence did not prove that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to repeatedly restart his treatment for obesity, namely by prescribing appetite suppressants in conjunction with diet recommendations. There were occasions when the Respondent prescribed an appetite suppressant when the patient's blood pressure reading was high. According to the medical and pharmaceutical literature and the expert medical testimony, caution should be exercised in prescribing these medications for patients with high blood pressure. But the exercise of that caution is a matter of medical judgment, based on an overall knowledge and understanding of the patient and circumstances involved. Only once, on April 3, 1992, did the Respondent prescribe an appetite suppressant (Tenuate Dospan) when the patient's blood pressure reading was so high (150/110) as to clearly contraindicate the use of the appetite suppressant. On all other occasions, the patient's blood pressure would be considered mildly or moderately high, requiring the Respondent to exercise caution, which he did. In all cases, the Respondent believed that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. Although some physicians would disagree with the Respondent's medical judgments, except for April 3, 1992, it was not proven that the Respondent's medical judgment in this case fell below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. However, it is found that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to prescribe Tenuate Dospan on April 3, 1992. It was not proven that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent not to refer the patient to a specialist for hypertension before April 14, 1992. The first evidence of severe hypertension appeared on her visit on March 16, 1992. But the Respondent had not seen the patient since December, 1991, due to missed appointments, and it was reasonable at that point for the Respondent not to refer immediately. It could be argued that he should have referred the patient after one of the next two visits, but the delay until April 14, 1992, was fairly short. It was not the Respondent's fault that the patient did not keep the appointment with the specialist which he made for her. It should be noted that the patient does not complain about the level of care and treatment given by the Respondent. Nor is there any evidence that the Respondent's care and treatment harmed the patient. Apparently, while the patient was hospitalized for overdosing on pain medication unrelated to the Respondent's care and treatment, the patient's medical records were brought to the attention of the predecessor of the AHCA, and it appeared to that agency (and to the AHCA) that the Respondent was guilty of worse practice of medicine than ultimately was proven in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent guilty of a single violation, on April 3, 1992, of Section 458.331(1)(t), which also resulted in a technical violation of Section 458.331(1)(q), Fla. Stat. (1993); (2) requiring the Respondent to notify the Board or the AHCA if he reopens his practice of medicine; (3) placing the Respondent on probation on appropriate terms in the event the Respondent reopens his practice; and (4) fining the Respondent $500. RECOMMENDED this 15th day of November, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of November, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-2375 To comply with the requirements of Section 120.59(2), Fla. Stat. (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-8. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Rejected as not proven. (The Respondent testified.) Accepted but subordinate and unnecessary. Accepted. First sentence, subordinate to facts contrary to those found; second sentence, subordinate to facts found. Rejected as not proven that the patient's hypertension was severe. Otherwise, accepted but subordinate to facts contrary to those found. 14.-19. Accepted and incorporated. Rejected as not proven, except for patients with severe hypertension. First sentence, rejected as not proven. (He believed it permissible because the patient's blood pressure was not stable.) Second sentence, accepted but subordinate to facts contrary to those found. Third sentence, accepted but subordinate to facts contrary to those found, and unnecessary. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven. Accepted. Subordinate to facts found. Accepted but subordinate to facts contrary to those found. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven as to Didrex after 1990; otherwise, accepted and incorporated. First sentence, accepted and incorporated. Second sentence, accepted but subordinate to facts contrary to those found, and unnecessary. (The AHCA did not charge inadequate records.) 27.-29. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Accepted but subordinate to facts contrary to those found. Accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted and incorporated. Rejected as not proven that referral was required in 1984 or that the patient's weight and blood pressure did not respond to treatment before 1988. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted but subordinate and unnecessary. Rejected. They knew it to the extent that it is the same as for an internist. 37.-38. Accepted but subordinate and unnecessary. 39. Rejected as not proven and as contrary to the facts found. Respondent's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5. Accepted but subordinate and unnecessary. 6.-20. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted but subordinate and unnecessary. 23.-28. Accepted and incorporated to the extent not subordinate or unnecessary. Other than evidence that she may have become nervous on occasion from the appetite suppressants, accepted and incorporated to the extent not subordinate or unnecessary. Accepted. The second occasion is irrelevant, having occurred after the events in issue in this case. The first is accepted and incorporated to the extent not subordinate or unnecessary. 31.-32. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted and incorporated. Accepted but subordinate and unnecessary. 36.-37. Accepted and incorporated. 38.-40. Accepted. Subordinate to facts found. First sentence, accepted and incorporated. Second sentence, accepted but subordinate and unnecessary. Accepted (that it is not necessarily inappropriate) and incorporated. Accepted. First two sentences, incorporated; second, subordinate to facts found. Accepted. Subordinate to facts found. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted but subordinate to facts found. 46.-47. Accepted and incorporated. 48. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted and incorporated. COPIES FURNISHED: Alex D. Barker, Esquire Elaine Lucas, Esquire Agency for Health Care Administration 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211-7466 John A. Naser, Esquire 1401 South Florida Avenue Suite 201 Lakeland, Florida 33802 Dr. Marm Harris Executive Director, Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
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.
The Issue The issue in this case is whether Florida Administrative Code Rules 11D-8.012 and 11D-8.013 are invalid exercises of delegated legislative authority.
Findings Of Fact The Petitioner has been charged with “DUI Manslaughter/Failed to Render Aid” and “Vehicular Homicide/Failed to Give Information or Render Aid” in Palm Beach County, Circuit Court Case No. 502010CF005829AXXXMB. The prosecution in the criminal case intends to offer the results of a blood alcohol test performed on blood collected from the Petitioner as evidence at the trial. The Petitioner has moved to exclude the blood alcohol test results from the trial based, in part, on the method used to collect his blood for forensic testing. The Respondent is the state agency responsible for implementing the “Implied Consent” blood alcohol testing program, including the adoption of rules. The Respondent has adopted such rules which are set forth in Florida Administrative Code Chapter 11D-8. The Petitioner has asserted that the Respondent’s “Implied Consent” rules are insufficient to ensure the scientific reliability of the blood alcohol test results to be offered against him in the criminal trial. On March 21, 2014, the circuit court judge presiding in the criminal trial entered an Order Granting State’s Motion to Invoke the Doctrine of Primary Jurisdiction, which specifically directed the Petitioner to file a petition challenging rule 11D-8.012 with the Division of Administrative Hearings. On April 24, 2014, the Petitioner filed a Petition to Determine the Invalidity of an Existing Rule, challenging rules 11D-8.012 and 11D-8.013 as invalid exercises of delegated legislative authority. The parties stipulated that the Petitioner is substantially affected by, and has standing to challenge the validity of, rules 11D-8.012 and 11D-8.013. Rule 11D-8.002 provides the following relevant definitions: (2) Accuracy - the nearness of a measurement to a known concentration. * * * (4) Agency - a law enforcement agency other than the Department, or an entity which conducts breath tests or submits blood samples for alcohol testing pursuant to these rules, or a civilian entity performing such duties on behalf of a law enforcement agency. * * * (7) Alcohol - ethyl alcohol, also known as ethanol. * * * Analyst - a person who has been issued a permit by the Department to conduct blood alcohol analyses. Approved Blood Alcohol Test - the analyses of two separate portions of the same blood sample using a Department- approved blood alcohol test method and a Department-approved procedure, with results within 0.010 grams of alcohol per 100 milliliters of blood (g/100mL), and reported as the blood alcohol level. * * * Blood - whole blood. Blood Alcohol Level - the alcohol concentration by weight in a person’s blood based upon grams of alcohol per 100 milliliters of blood (g/100mL). * * * (19) Department - the Florida Department of Law Enforcement. * * * (22) Methods - types of alcohol analyses approved by the Department to conduct chemical or physical tests of blood or breath. * * * (24) Permit - when issued by the Department, certifies that the holder has met all necessary qualifications, remains in full compliance with these rules and is authorized to perform all related duties. A permit is issued only to a qualified applicant and remains valid and in full effect until determined otherwise by the Department. Rule 11D-8.012 The Petitioner has asserted that rule 11D-8.012 is an invalid exercise of delegated legislative authority because the rule does not establish a venipuncture procedure regulating needle gauge and tourniquet usage by which blood is obtained for the purpose of performing a blood alcohol test. At the same time, the Petitioner asserts, and the Respondent agrees, that the Respondent lacks statutory authority to adopt such a rule. Rule 11D-8.012 provides as follows: Blood Samples - Labeling and Collection. Before collecting a sample of blood, the skin puncture area must be cleansed with an antiseptic that does not contain alcohol. Blood samples must be collected in a glass evacuation tube that contains a preservative such as sodium fluoride and an anticoagulant such as potassium oxalate or EDTA (ethylenediaminetetraacetic acid). Compliance with this section can be established by the stopper or label on the collection tube, documentation from the manufacturer or distributor, or other evidence. Immediately after collection, the tube must be inverted several times to mix the blood with the preservative and anticoagulant. Blood collection tubes must be labeled with the following information: name of person tested, date and time sample was collected, and initials of the person who collected the sample. Blood samples need not be refrigerated if submitted for analysis within seven (7) days of collection, or during transportation, examination or analysis. Blood samples must be otherwise refrigerated, except that refrigeration is not required subsequent to the initial analysis. Blood samples must be hand-delivered or mailed for initial analysis within thirty days of collection, and must be initially analyzed within sixty days of receipt by the facility conducting the analysis. Blood samples which are not hand-delivered must be sent by priority mail, overnight delivery service, or other equivalent delivery service. Notwithstanding any requirements in Chapter 11D-8, F.A.C., any blood analysis results obtained, if proved to be reliable, shall be acceptable as a valid blood alcohol level. Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3., (d) FS. Law Implemented 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.353(2), 327.354(3) FS. Commercially available kits, generally containing glass evacuation tubes, a non-alcohol skin wipe, and a 21-gauge needle assembly, may be used to collect samples for blood alcohol testing. The Respondent’s rules do not require usage of such kits, and the components of the kits are commonly available where blood collection is performed. The Legislature identified the persons authorized to collect samples for blood alcohol testing in section 316.1933(2)(a), Florida Statutes, which states as follows: Only a physician, certified paramedic, registered nurse, licensed practical nurse, other personnel authorized by a hospital to draw blood, or duly licensed clinical laboratory director, supervisor, technologist, or technician, acting at the request of a law enforcement officer, may withdraw blood for the purpose of determining the alcoholic content thereof or the presence of chemical substances or controlled substances therein. However, the failure of a law enforcement officer to request the withdrawal of blood shall not affect the admissibility of a test of blood withdrawn for medical purposes. The Petitioner asserts that the gauge of the needle used to puncture a vein for blood collection and improper application of a tourniquet during the collection process can result in “hemolysis” of blood and an inaccurate blood alcohol test result. As noted above, rule 11D-8.002(14) defines “blood” to mean “whole blood.” Whole blood is comprised of four components, including white cells, red cells, platelets, and plasma. Hemolysis is the release of the contents of red blood cells (hemoglobin) into blood plasma. Hemolysis can occur from a variety of causes, including, but not limited to, the manner of collection (regardless of the gauge of the needle used to puncture the vein), improper agitation of a sample in the collection tube, and storage of a sample. All blood alcohol testing performed by forensic laboratories in Florida is conducted through “gas chromatography headspace analysis.” Extensive testimony was presented at the hearing as to the process of gas chromatography headspace analysis. The reliability and accuracy of the gas chromatography headspace analysis process is not at issue in this proceeding. Gas chromatography headspace analysis involves the removal and testing of a subsample of the blood sample contained in a collection tube. A subsample taken from a sample that exhibits hemolysis contains all of the components present at the time of collection and is whole blood. The evidence fails to establish that hemolysis alters the concentration of alcohol within a subsample taken from a sample of whole blood. The evidence fails to establish that hemolysis affects the results of a blood alcohol test performed on whole blood by gas chromatography headspace analysis. Rule 11D-8.013 Rule 11D-8.013 governs the issuance of permits to analysts conducting blood alcohol tests, including a requirement that analysts define the method and procedures to be followed in conducting the tests. The Petitioner has asserted that the rule is an invalid exercise of delegated legislative authority because the rule does not explicitly require analysts performing a blood alcohol test to identify and/or exclude an “unreliable” blood sample from the testing process. Essentially, the Petitioner argues that samples exhibiting hemolysis or coagulation should not be analyzed for alcohol content. Rule 11D-8.013 provides as follows: Blood Alcohol Permit - Analyst. The application for a permit to determine the alcohol level of a blood sample shall be made on a form provided by the Department and shall include the following information: Name and address of applicant; A copy of state license if licensed, or college transcript; Name and address of employer and laboratory facility where applicant performs analyses; Identify at least one Agency for which blood analyses are to be performed pursuant to Chapters 316, 322, and 327, F.S.; and, A complete description of proposed analytical procedure(s) to be used in determining blood alcohol level. Qualifications for blood analyst permit - To qualify, the applicant must meet all of the following requirements: Department approval of analytical procedure(s). All proposed analytical procedures will be reviewed and a determination of approval will be made by the Department; Satisfactory determination of blood alcohol level in five proficiency samples provided by the Department using the proposed analytical procedure. Satisfactory determination shall be made by reporting results for blood alcohol proficiency samples within the acceptable range for the samples. For blood alcohol testing, acceptable ranges shall mean the calculated proficiency sample mean + or - 3 standard deviations iterated twice. The mean and standard deviations will be calculated using the results reported by the analysts and reference laboratories; Identify at least one Agency for which blood analyses are to be performed pursuant to Chapters 316, 322, and 327, F.S.; and, Meet one of the following: Possess a clinical laboratory license in clinical chemistry as a technologist, supervisor or director, under Chapter 483, F.S.; or Be a licensed physician pursuant to Chapter 458, F.S.; or Complete a minimum of 60 semester credit hours or equivalent of college, at least 15 semester hours of which must be in college chemistry. The department shall approve gas chromatographic analytical procedures and enzymatic analytical procedures based on alcohol dehydrogenase which meet the following requirements: Includes the approved method used and a description of the method, and the equipment, reagents, standards, and controls used; Uses commercially-prepared standards and controls certified by the manufacturer, or laboratory-prepared standards and controls verified using gas chromatography against certified standards. For commercially-prepared standards and controls, the manufacturer, lot number and expiration date must be documented for each sample or group of samples being analyzed. For laboratory-prepared standards and controls, date, person preparing the solution, method of preparation and verification must be documented; A statement of the concentration range over which the procedure is calibrated. The calibration curve must be linear over the stated range; Uses a new or existing calibration curve. The new calibration curve must be generated using at least three (3) standards: one at 0.05 g/100mL or less, one between 0.05 and 0.20 g/100mL (inclusive) and one at 0.20 g/100mL or higher, and must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher. The existing calibration curve must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher; Includes the analysis of an alcohol- free control, and the analysis of a whole blood or serum control. The whole blood or serum control may be used to satisfy the control requirement(s) in paragraph (d); A gas chromatographic analytical procedure must discriminate between methanol, ethanol, acetone and isopropanol and employ an internal standard technique; An enzymatic analytical procedure based on alcohol dehydrogenase must use the procedure recommended by the instrument manufacturer/test kit vendor for whole blood alcohol analysis, and the enzyme used must have sufficient selectivity to provide negligible cross-reactivity towards methanol, acetone and isopropanol. The permit shall be issued by the Department for a specific method and procedure. Any substantial change to the method, analytical procedure, or laboratory facility must receive prior approval by the Department before being used to determine the blood alcohol level of a sample submitted by an agency. The Department shall determine what constitutes a substantial change. An analyst shall only use a Department- approved procedure to determine the blood alcohol level of samples submitted by an agency. Approval of blood alcohol analysis methods and procedures shall be based on rule requirements in effect at the time they were submitted for approval. Specific Authority 316.1932(1)(a)2., (f)1., 316.1933(2)(b), 316.1934(3) 322.63(3)(b), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b), 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(b), (e), 327.353(2), 327.354(3) FS. Analysts submit the procedures referenced in the rule in the form of written “standard operating procedures” (SOP) filed with the Respondent. No SOP was admitted into the record of the hearing. As set forth above, the evidence fails to establish that hemolysis affects the results of a blood alcohol test performed on whole blood by gas chromatography headspace analysis. A subsample taken from a sample that exhibits hemolysis contains all of the components present at the time of collection and is whole blood. Accordingly, the evidence fails to establish that a sample exhibiting hemolysis should be excluded from testing. Notwithstanding the requirement in rule 11D-8.012 that glass evacuation tubes containing a preservative and an anticoagulant be used in the collection process, a collection tube containing a blood sample submitted for testing can, on occasion, include coagulated blood. Coagulation can occur for a variety of reasons, including the type of needle used in the collection process or the failure to mix the sample properly with the anticoagulant contained in the tube. Rule 11D-8.002(15) defines “blood alcohol level” as “the alcohol concentration by weight in a person’s blood based upon grams of alcohol per 100 milliliters of blood (g/100mL).” The entire sample in a collection tube containing a portion of coagulated blood contains all of the components that were present in the “whole blood” of the subject from whom the blood was collected. However, coagulation causes some of the blood components to solidify. Alcohol (ethanol) is water-soluble. Coagulation alters the ratio of liquid to solid in the sample and can increase the concentration of alcohol in the liquid portion of the sample. The evidence fails to establish that the mere presence of coagulation inevitably precludes the withdrawal of a subsample that properly reflects the components of the whole blood contained in the collection tube. Because gas chromatography headspace analysis uses a subsample of the liquid portion of the sample, the accuracy of the blood alcohol level reported by the subsample is related to the degree of coagulation present in the sample.
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor in Florida, having been issued License No. ME 0031092. She has a general family practice and is not board certified or board eligible in any specialty. The charges here involved stem from the treatment of six patients by the Respondent, who was the admitting physician for these patients at Lykes Memorial Hospital (Lykes) in Brooksville, Florida. PATIENT A. S. When first seen in Respondent's office on December 3, 1983, A. S. was a 62 year old female who had been seen at the Lykes emergency room a few days earlier complaining of pain in the right shoulder and indigestion. When seen by Respondent, A. S. complained of stabbing pain in her right side, frequency of urination and constipation. Respondent did a complete physical on A. S. and discussed the patient's symptoms with Dr. Nazir Hamoui, a board certified urologist who concurred in the decision to hospitalize A. S. A urinalysis taken in Respondent's office noted bacteria too numerous to count and the white blood cell count within the normal range. During her examination, A. S. stated she was allergic to codeine, ampicillin and aspirin which Respondent noted on the patient's record. While in the hospital the day before A. S.'s admission to Lykes, Respondent prepared the preadmission order in which she prescribed Tylenol 3 and Keflin for A. S. Upon returning to her office that evening and reviewing A. S.'s chart, Respondent realized Tylenol #3 which contains codeine, to which A. S. stated she was allergic, and Keflin were improper drugs to prescribe to this patient. The following morning, prior to A. S.'s admission, Respondent directed the prescription for Tylenol #3 be changed to Demoral, and the prescription for Keflin was changed to Erythromycin. These changes did not get placed on the patient's chart until after 12:25 when A. S. was offered Tylenol and refused it. A. S. was admitted to the hospital at 11:55 on December 4. Upon admission, the admitting diagnosis for A. S. was: right flank pain, rule out pyelonephritis, rule out diverticulitis. Petitioner's experts witnesses testified the Respondent's records on A. S. would not support a diagnosis of possible diverticulitis and pyelonephritis; however, this testimony respecting pyelonephritis was based largely upon their conclusion that the urine specimen showing high bacteria count was probably contaminated. Respondent's notes did not indicate how the specimen was obtained. Respondent testified that she had established office policies in which the nurses explained to patients how to catch a clean sample, and that these procedures were followed in all cases. While A. S. was hospitalized, Dr. Hamoui was called in as a consultant and he determined that a cystoscopy was necessary, and he performed that procedure. Petitioner's witnesses also opined that the evidence contained in the patient's office records was insufficient to support a diagnosis of possible diverticulitis which was to be ruled out by the barium enema tests. Several reasons for this conclusion were given, yet one of the discharged diagnoses was possible diverticulitis. The other discharge diagnoses were chronic cystitis, urethral stricture and one degree heart block. PATIENT B. L. B. L. was a 71 year old female when first seen by Respondent on October 23, 1984. B. L. complained of pressure in her lower abdomen, pain during urination, bowel problems and constipation. A urinalysis showed 2+ sugar in the urine. A blood sugar test taken this same date was reported by the lab to be 209. Patient records are unclear whether this was from a random sample, fasting or two hour post prandial. B. L. was also seen by Dr. P. G. Desai, a board certified urologist, in Respondent's office on October 23, 1983, and he decided surgical intervention was indicated, and this required hospitalization. Additional blood sugar tests were run on blood drawn from B. L. on October 24 and October 25. Although the office records do not clearly so indicate, Respondent testified that these blood tests were two hour post prandial or fasting. The post prandial readings were 209 and 196, and the fasting blood sugar test resulted in a reading of 141. All of these readings are at or slightly above the upper range for normal or lower range for diabetes. Respondent put B. L. on a 1500 calorie diet and prescribed Orinase. While prescribing Orinase was questionable in view of the blood sugar readings and possible complication if a low blood sugar condition is obtained, B. L. was scheduled for surgery, and Respondent thought the Orinase would lower the blood sugar enough to allow the surgery to proceed without the complications of diabetes. Respondent had diagnosed B. L. as having urinary retention, caruncle, possible urethral stricture and diabetes uncontrolled. B. L. told Respondent that she had trouble staying on a diet. Respondent took B. L. off Minizide which she had been on for some time and prescribed Diazide. Diazide can significantly affect blood sugar by increasing it 5 or 10 percent. This change in medication, therefore, could have affected the blood sugar reading for B. L. PATIENT M. H. Respondent first-saw this patient on July 23, 1983 for an insect bite. Subsequent thereto, on September 17, 1983, at an office visit, M. H. revealed to Respondent an extensive history of transient ischemic attacks (TIA) for which she had earlier been tested and to control which she took aspirin every day. Respondent suggested that M. H. undergo a work-up for TIA, but M. H. declined since she did not want to undergo those procedures again. On October 4,1983, M. H. came to Respondent's office complaining of frequency of urination, sporadic blood in urine, a 5 to 6 pound weight loss, anxiousness and an old history of vision problems, and a few times on and off weakness in the arms. Upon examination of M. H., Respondent found blood in the patient's urine (hematosis). M. H. was admitted to the hospital by Respondent with differential diagnosis of hematuria, etiology to be determined; weight loss, etiology to be determined; hypertension by history; numbness of the left hand; and transient ischemic attacks, rule out CVA. While in the hospital, M. H. was seen by Dr. Nazir Hamoui, a board certified urologist, who determined that a cystourethroscopy and urethral dilation were necessary, and which he performed. Prior to performing this surgery, Dr. Hamoui carefully examined the patient for evidence of active symptoms of TIA and found none. The primary emphasis of the evidence submitted by Petitioner on the treatment rendered by Respondent, was that TIA is a precursor to strokes and that Respondent should have done more to push M. H. to consenting to a TIA work- up. However, these witnesses both admitted on cross-examination that the patient has the final word on whether a certain procedure is done, and that if the patient declines to have a TIA work-up, there is nothing more a physician can do. Fasting blood tests taken on this patient revealed blood sugar slightly higher than the normal range, and Respondent made a discharge diagnosis of borderline diabetes mellitus. PATIENT L. R. L. R. was admitted to Lykes on February 16, 1984 with a differential diagnosis of acute bronchitis and possible bilateral pneumonia. During hospitalization, one blood sugar reading of 97 was obtained, and the discharge diagnosis included "borderline diabetes." One blood sugar reading of 97 will not support a diagnosis of borderline diabetes. Although Respondent contends the diagnosis was based upon the patient's past history, the Respondent's office records would not support this diagnosis, and the hospital records for this history was missing from the file. At the time of the hearing, the hospital records for this patient contained no patient physical or history. Hospital policy requires all records to be complete and include both a history and physical before they can be closed. No one was able to explain the absence of these documents from the hospital records, and it is as likely they were removed from the file after closing as it is that they were never prepared by Respondent and placed in the file. Accordingly, no permissible inference can be drawn that Respondent failed to take a history and physical on L. R. Respondent treated this patient with an aminophylline IV solution without monitoring theophylline level in the patient's blood. Aminophylline is a dangerous drug with a low margin of safety. Too much theophylline in the blood will be toxic to the patient, and too little will not be effective. Here the IV solution was administered for only a short period of time, and no side effects were seen. PATIENT C. K. After treating this patient in her office for a short period, Respondent admitted C. K. to Lykes for further treatment with a diagnosis of abdominal pain, bloody diarrhea, possible acute diverticulitis, rule out ulcerative colitis and rule out infection. While hospitalized, C. K. was seen by Dr. P. K. Paul, a board certified gastroenterologist, who determined a proctosigmoidoscopy was indicated, which he performed. Dr. Paul concurred with testing the patient for diverticulitis. When discharged seven days after admission, the discharge diagnosis of C. K. was internal hemorrhoids and proctitis. It is rare for a thirty-two year old woman to have diverticulitis. Petitioner's expert witness opined that a general practitioner should be able to diagnose internal hemorrhoids and proctitis without calling in an expert; while Respondent's expert witnesses, who were equally, if not better qualified, opined that respondent's actions were proper. PATIENT R. B. R. B. was seen in Respondent's office on March 24, 1984, and was admitted to the hospital the same day with an admitting diagnosis of acute abdomen, abdominal pain, rule out appendicitis, rule out colitis, G. I. bleeding. In the admitting order, Respondent directed R. B. receive nothing by mouth and an IV set at keep vein open. Dr. Soliman, a consultant called in, changed the order to sips of water and finally to full liquids. Normally a patient with suspected appendicitis will be kept hydrated, but not allowed to take liquids orally. Two of the expert witnesses called by Respondent, one a board certified urologist and the other, a board certified gastroenterologist and internist, both testified that the admission of R. B. to the hospital was proper as were the admission orders. GENERAL The principal import of the charges here involved is that Respondent called in consultants when it should not have been necessary, admitted patients to the hospital when not justified and diagnosed patients with diabetes on insufficient evidence. Respondent's own testimony that she called in a consultant every time before admitting a patient to the hospital supports the excessive use of consultants. However, this does not equate with malpractice. At the time the hospital admissions here complained of occurred, a major change in Medicare reimbursements also took place with the advent of Diagnostic Related Groups (DRG) whereby the U.S. Government withdrew the blank check formerly given the hospitals to fill in and inserted fixed payments for specified diagnoses. This resulted in hospitals no longer encouraging doctors to admit patients to the hospital, unless the diagnosis was such that someone would pay for the patient's hospital expenses. Although no direct testimony was presented in this regard, it appears that Respondent was caught in this transition, and the hospital had difficulty getting treatment received by the patients and whether Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. With respect to the patient records maintained by Respondent, Petitioner's expert witnesses' primary complaints were that the records were not complete in that blood and urine samples taken for tests were not definitive in that the blood test often did not indicate whether it was a fasting test, two hour post prandial or random. Similar for the urine samples taken, the records did not specify how the sample was taken so as to insure a clean catch. Respondent testified that all blood sugar tests were fasting or two hour-post prandial and that standard office procedures were set up to be sure uncontaminated urine specimens were obtained. Other objections to these records resulted from the witnesses being unable to read Respondent's handwriting or decipher some of the abbreviations used. When the record was understood, some of these objections were withdrawn. It could be said that all or nearly all patient records could be more complete and the handwriting easier to read. Petitioner's witnesses also contended that the blood sugar readings on several of these patients were not high enough to justify a diagnosis of diabetes or borderline diabetes, yet one of these patients is today still being treated for diabetes. It clearly appears that Respondent is more likely to diagnose an elderly patient with elevated blood sugar levels as diabetic than would many other family practitioners. However, this does not equate to clear and convincing evidence that patient records fail to justify the diagnosis or treatment of these patients by Respondent. Respondent's expert witnesses, who were equally, if not better, qualified than were Petitioner's witnesses, all opined that the patient records were adequate. The fact that Respondent conferred with a specialist before admitting each of her patients to the hospital indicates that Respondent is unsure of her diagnosis or is ultraconservative. Again, the parties' expert witnesses were poles apart in their testimony regarding whether the diagnoses and treatment of six patients was below the minimally acceptable standards. This does not constitute clear and convincing evidence that Respondent failed to practice medicine with the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Finally, it is noted that in Exhibit 25 of the Board of Medical Examiners took disciplinary action against Respondent at a time well after the treatment of the patients involved in these charges. Although the basis for that action was not included in Exhibit 25, it would appear that the investigation that led to the stipulation and Exhibit 25, if thorough, should have revealed the charges here involved, and these charges should have been disposed of at that time. Regardless of the fact that these charges were not then considered (in 1985), Exhibit 25 may not now be used in aggravation of the charges involving events occurring before Exhibit 25 was entered should Respondent be found guilty of these charges. From the foregoing, it is concluded that Petitioner has failed to prove, by clear and convincing evidence, that Respondent failed to keep medical records justifying the course of treatment on the six patients, or failed to practice medicine with the level of care, skill and treatment which a reasonably prudent physician recognizes as acceptable under similar conditions and circumstances. It is RECOMMENDED that all charges against Raees Iftekhar Gazi be dismissed. ENTERED this 1st day of November, 1988, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of November, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-1398 Treatment Accorded Petitioner's Proposed Findings 1. Included in H.O. #1. 2. Included in H.O. Preamble. 3. Included in H.O. #2. 4. Included in H.O. #3. 5,6,7,8,9 Included in H.O. #4. 10,11. Included in H.O. #6. 12. Rejected as speculation. 13. Rejected as speculation. 14. Included in H.O. #4. 15. Included in H.O. #6. 16,17. Accepted. 18. Included in H.O. #6. Accepted. Last sentence rejected as irrelevant. Rejected. Included in H.O. #8. Rejected. Rejected. 25,26,28. Included in H.O. #5. 27. Accepted. 29. Included in H.O. #4. 30,31. Included in H.O. #5. 32,33. Accepted. 34,35. Included in H.O. #5. 36. See H.O. #5. 37. See H.O. #5. 38. Included in H.O. #5. 39. Accepted. 40. Accepted. 41. Rejected. 42. Accepted. 43,44,45,46. Included in H.O. #5. 47. Rejected. 48. Rejected. 49. Rejected. 50. Accepted. 51,52,53. Included in H.O. #9. Accepted, but irrelevant. Accepted. Included in H.O. #12. Included in H.O. #11. 58-60. Accepted. Included in H.O. #12. Included in H.O. #11. Accepted. Included in H.O. #11. Rejected. Rejected. Accepted. 68,69,70,71. Included in H.O. #13. 72. Included in H.O. #12. 73,74,75. Accepted. Rejected. Rejected. 78,79. Accepted. 80,81. Included in H.O. #14. 82. Accepted. 83,85. Included in H.O. #15. 84. Included in H.O. #16. Accepted. Included in H.O. #17. 88,89,90,91,92. Accepted. Included in H.O. #19. Accepted. 95,96,97. Included in H.O. #20. 98,99. Included in H.O. #21. 100,101. Included in H.O. #20. 102,103,104. Included in H.O. #22. Included in H.O. #23. Included in H.O. #24. Included in H.O. #25. Accepted. Included in H.O. #25. 110,111,112. Accepted. 113. Included in H.O. #26. 114,115. Included in H.O. #27. 116,117. Included in H.O. #28. 118-122. Accepted. However, these are ideals which are rarely met by the average physician. 123,124. Included in H.O. #29. Treatment Accorded Respondent's Proposed Findings 1. Included in Preamble. 2,3. Included in H.O. #1. Included in H.O. #21. Included in Preamble. Included in H.O. #3. Included in H.O. #4. Included in HO. #6. Included in H.O. #7. Accepted. Rejected insofar as relating to Petitioner's witness. Included in H.O. #8. Accepted. 14,28,42,58,50,72. Rejected as immaterial. 15,16. Included in H.O. #5. 17-20. Accepted. 21,22. Rejected as conclusion only. 23. Included in H.O. #10. 24,25,26. Accepted. 27. Included in H.O. #10. 29. Rejected. 30,31. Included in H.O. #11. 32,33. Included in H.O. #12. Rejected as conclusion only. Accepted. Included in H.O. #20. Included in H.O. #21. Included in H.O. #20. Accepted insofar as included in H.O. #22. 40,41,43,44,46. Accepted. 45. Rejected as conclusion only. Included in H.O. #23. Included in H.O. #24. Accepted. Included in HO. #24. Accepted as testimony of witness. Accepted. Included in H.O. #26. Accepted. Included in H.O. #28. 56,57. Accepted. Accepted as mere testimony of witness. Rejected as conclusion. Accepted. Included in H.O. #14. 63,64. Accepted. Included in H.O. #15. Included in H.O. #16. Included in H.O. #17. 68,69. Accepted. Included in H.O. #17. Accepted. Rejected as conclusion only. Accepted. 75,76. Accepted. 77-79. While one of Petitioner's expert witnesses did express some confusion regarding the term "standard of care", nevertheless, this witness opined that much of the treatment Respondent provided these six patients was below acceptable standards. In view of the opinions expressed by the witnesses called by Respondent, it is concluded that Petitioner failed to sustain its burden of proof; not that Respondent is an exemplary physician. COPIES FURNISHED: David Milford, Esquire Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32399-0750 Jerry Gottlieb, Esquire 2753 State Road 580 Suite 204 Clearwater, Florida 34621 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce D. Lamb General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
