The Issue The issue is whether Respondent is guilty of failing to practice in accordance with the applicable standard of care or failing to keep adequate medical records and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 44240. He has been licensed in Florida since 1984. Respondent has practiced plastic surgery, particularly cosmetic plastic surgery, for the past 22 years. Respondent is certified by the American Board of Plastic Surgery in plastic surgery. He was also certified in Advanced Cardiac Life Support (ACLS) at the time of the surgery in question. The Board of Medicine previously disciplined Respondent by Final Order filed September 1, 1995, pursuant to a Consent Agreement into which the parties had entered. The Consent Agreement arose from allegations that Respondent had failed to remove a sponge from a breast during breast augmentation surgery. Respondent did not admit the allegations, but agreed to pay a $2000 fine and attend ten hours of continuing medical education. The Administrative Law Judge admitted this evidence strictly for the purpose of penalty, not liability. Respondent performs plastic surgery at the Cosmetic Surgery Center in Fort Lauderdale. The 5000 square-foot facility contains three examination rooms, two operating rooms, one recovery room, and an overnight hospital. Another physician also operates at the Cosmetic Surgery Center, which employs a wide range of staff, including a patient coordinator, nurse practitioner, and a certified register nurse anesthesiologist (CRNA). In the past, the Cosmetic Surgery Center retained a CRNA to assist in surgery on an as-needed basis. However, since mid-2005, the Cosmetic Surgery Center has regularly employed a CRNA after the Board of Medicine issued an Order of Emergency Restriction of License on June 8, 2005. Issued in response to the incident described below, the emergency order requires, among other things, that Respondent employ a CRNA or M.D. anesthesiologist to administer anesthesia at all surgeries, unless the surgery will involve Level I sedation. The emergency order also requires Respondent to obtain an unqualified surgical clearance from every patient's primary care physician. Respondent has performed over 10,000 procedures using Level II sedation over 25 years. Level II sedation leaves the patient conscious, but tranquil, and responsive to painful stimulus or verbal command. Level III sedation leaves the patient unconscious. This case involves a 50-year-old female, S. B., who presented to Respondent's office on July 9, 2003, to discuss the possibility of an abdominoplasty, breast augmentation, and arm lift. Respondent had previously performed an abdominoplasty, which is also known as a tummy tuck, on S. B.'s daughter, who wanted to make a present of cosmetic surgery for her mother. After examining S. B., Respondent recommended against any work on the arms, as the surgical scars would outweigh the benefits of the surgery for S. B. During this initial office visit, Respondent took a history from S. B., who had three children and was employed as a receptionist for a local roofing company. S. B. stated that her general health was good, and she had never had significant complications from any surgery. She reported that her only medical problem was hypertension and that she consequently took clonidine and Lasix. She stated that she had never reacted badly to general or local anesthesia, did not bruise easily, and did not bleed excessively from cuts. The form asked the patient to list intoxicating or mind-altering drugs, and S. B. did not list any. At no time during the July 9 visit did S. B. express an intent to proceed with the surgery, and, in fact, she was undecided at the time and remained so for several months. Respondent next saw S. B. on December 11, 2003, when she presented at his office for a pre-operative examination. Respondent again discussed the surgical procedures. During this visit, S. B.'s blood pressure was 210/112, which was too high for Respondent to perform elective surgery. Instead, he discussed with S. B. the need to control her blood pressure and learned that she had quit taking her blood pressure medication. Respondent told S. B. to see her primary care physician to control the blood pressure. Respondent's notes document S. B.'s blood pressure, the referral, and the purpose of the referral. In anticipation of surgery on December 23, 2003, Respondent prescribed on December 11, 2003, fifteen 500-mg tablets of Duricef, fifteen 10-mg tablets of Lorcet, and fifteen 30-mg tablets of Restoril. Duricef is an antibiotic. An analgesic, Lorcet combines 10 mg of hydrocodone, an opioid, with acetaminophen. Restoril, or temazepam, is a sedative in the benzodiazepine family and is similar to Valium. Respondent typically prescribes these or similar medications, so that his patients can fill them prior to surgery and take them following surgery. On December 11, 2003, Respondent also ordered pre- surgical lab work. The lab report, dated December 12, 2003, states that S. B.'s values were largely normal. However, S. B.'s prothrombin time (PT), which measures clotting time, was very slightly elevated. The normal range for this parameter for this laboratory is 11-13 seconds, and the PT for S. B. was 14.8 seconds. However, the International Normalization Ratio (INR), which normalizes results among labs and tissue samples, was 1.4, which is within the normal range, as was the partial thromboplastin time (PTT), which is another measure of clotting time. S. B.'s red blood cell count was very slightly high (6.13 as compared to a range of 4.2-6.1 units per liter). Also very slightly low were S. B.'s M.C.V. (79.0 as compared to a range of 80.0-99.0 units), M.C.H. (26.3 as compared to a range of 27.0-31.0 units), and M.C.H.C (32.7 as compared to a range of 33.0-37.0 units per liter). Very slightly high was S. B.'s R.D.W. (15.4 as compared to a range of 11.5-15.0 percent). Except for the red blood cell count, the other parameters pertain to precursors of cells. The next day, Respondent added to the pre-operative prescriptions two 5-mg tablets of Mephyton, which is vitamin K. The medical records contain no discussion of why Respondent added vitamin K the day after he had ordered the other pre- operative medications. Most likely, this information would have been contained in Respondent's notes, which are in a handwritten scrawl that is partly illegible. Clearly, though, Respondent's notes fail to disclose the purpose of ordering Respondent to take vitamin K. Respondent testified that he was responding to the PT value, explaining that he gives vitamin K to patients with borderline clotting studies, so that the patients will not experience as much bruising and swelling. More important than the records' failure to contain an explanation for the ordering of vitamin K is their failure to address the high PT value in Respondent's plan of treatment for S. B. Even if only borderline high and more suggestive of problems involving only bruising and swelling, the PT raised a clotting issue, which is of obvious importance given the nature of the contemplated surgery. Respondent's records must address this issue and the impact, if any, on the contemplated surgery. In retrospect, the PT abnormality proved irrelevant. S. B. did not display any clotting problems or excessive bleeding during the surgery. At the hearing, Respondent explained the limitations of a PT value, especially when it is unaccompanied by an abnormal INR, although Respondent obviously thought enough of the PT test to order one for S. B. More cogent is Respondent's explanation at the hearing that the absence of any reported history of bleeding or bruising outweighed any concerns raised by a slightly elevated PT value, but this persuasive analysis is nowhere to be found in the medical records. Petitioner argues alternatively, though, that the slightly elevated PT value should have alerted Respondent to cirrhosis, which is discussed in more detail below. At the pre- operative stage, at least, the history, findings, and complaints did not support a diagnosis of cirrhosis. In his pre-operative physical examination, Respondent found no evidence of jaundice or edema. S. B.'s anemia had resolved. Her history lacked any indication of liver disease, nor did S. B. complain of any symptoms consistent with cirrhosis. These facts, as well as the information supplied by S. B.'s primary care physician, justified Respondent's failure to explore the possibility of liver disease prior to proceeding with surgery. Nor did the circumstances impose a duty on Respondent to include in the medical records a plan of treatment that addressed the possibility of cirrhosis. The facts reasonably known to Respondent did not raise the possibility of cirrhosis, any more than they raised the possibility of heroin use by S. B. It is thus irrelevant to Respondent's documentation duties, although not necessarily to her death approximately 30 hours after the end of the surgery, that S. B. suffered from some degree of cirrhosis and used heroin. On December 31, 2003, S. B.'s primary care physician completed a "Medical Clearance" form, even though Respondent had not requested a medical clearance, but had required only that the physician do what was necessary to get S. B.'s blood pressure under control. On the form, S. B.'s primary care physician noted that S. B.'s past history consisted of hypertension and, in June 2000, anemia. The addition of the date implied that S. B. no longer suffered from anemia--a fact borne out by her elevated red blood cell count. On the form, the primary care physician noted that her blood pressure was 160/98 and pulse was 80, changed one of S. B.'s blood pressure medications, and cleared her for surgery under local and general anesthesia, "once BP < 150/90." Two items on the Medical Clearance form support Respondent's decision not to investigate the possibility of liver disease before performing surgery. First, as noted above, the form indicates that S. B.'s anemia had resolved. It would be reasonable to assume that S. B.'s primary care physician was especially attentive to indicators of anemia or liver disease given this history. Second, the Medical Clearance indicates that S. B.'s primary care physician had ordered a comprehensive metabolic panel, which would include tests of liver function. The absence of any further contact from the primary care physician implies that the comprehensive metabolic panel revealed nothing of importance as to liver function, and the function of the liver is obviously important--not its post- mortem condition. On January 15, 2004, S. B. presented at the Cosmetic Surgery Center for an abdominoplasty with liposuction to the waist area. Respondent's scrawled notes do not disclose why he or S. B. decided not to proceed with the breast augmentation. In the pre-operative evaluation, which is initialed by Respondent, S. B.'s pulse was 95, and her blood pressure was 162/96, with the notation that she was nervous. Her rating on the American Society of Anesthesiologists (ASA) scale is I, meaning that she has no disease. Respondent concedes that her hypertension warranted a II, which means some systemic disease, but not threatening. However, the mis-rating on the ASA scale is irrelevant because it did not impact her treatment or outcome. The pre-operative evaluation contains two other notations of interest. First, Respondent planned for S. B. to remain overnight at the Cosmetic Surgery Center, rather than to discharge her to home on the day of the surgery or transfer her to a hospital. Thus, her remaining at the facility the night of the surgery did not suggest an unusually difficult surgery or recovery. Second, Respondent found S. B. fit for surgery under I.V. sedation in the office, rather than local or general anesthesia. Obviously, the pre-operative evaluation reports a blood pressure in excess of the maximum listed in the medical clearance that Respondent had received from S. B.'s primary care physician. Respondent's medical records fail to address this discrepancy and the broader issue of S. B.'s blood pressure, which was about the same as it was when she visited her primary care physician, but considerably lower than when she last visited Respondent. Respondent could and did reasonably exercise his own medical judgment and proceed with surgery despite a blood pressure in excess of the maximum on the medical clearance, but given this recommendation, S. B.'s extremely elevated blood pressure a month earlier, the challenges of maintaining reasonable blood pressure levels intra- and post- operatively, and S. B.'s hypertensive condition, Respondent was required to document his reasoning for proceeding with surgery despite the relatively high blood pressure. At hearing, Respondent offered a persuasive explanation of why he proceeded to perform the surgery despite a blood pressure reading over 150/90. Attributing the elevated blood pressure (and pulse) to adrenalin-producing anxiety, not hypertension, Respondent decided that he would be able to control S. B.'s blood pressure adequately during surgery with sedatives and blood pressure medication. Considerable evidence indicates that S. B. was a very nervous patient. S. B.'s pulse was also quite rapid on both visits. As was the case with the PT value, it is easier to credit Respondent's reasoning given hindsight, as he successfully controlled S. B.'s blood pressure during surgery. During surgery, Respondent's nurse practitioner, Michelle Huff, monitored heart function by an EKG, blood oxygenation and pulse by a disposable pulse oximeter, blood pressure, and respiration. During the surgery, Respondent was also assisted by Tiffany Archilla, a certified surgical technologist. At Respondent's direction and under his supervision, Nurse Hoff, administered the following drugs immediately before and during surgery: Diprivan, which is an anesthetic whose specific effect depends on rate of administration; Versed, which is a sedative; Robinul, which controls nausea; Ancef, which is an antibiotic; fentanyl, which is an analgesic and anesthetic; and labetalol, which controls blood pressure. Nurse Huff also administered oxygen and nitrous oxide, which is an anesthetic. Nurse Huff had been working at the Cosmetic Surgery Center for only two months at the time of S. B.'s surgery. Nurse Huff is not a CRNA, but is an advanced registered nurse practitioner and has been a registered nurse for 14 years. At the time of the hearing, she had been employed for three years at the Cosmetic Surgery Center, where she also had completed an internship. She estimates that she has participated in over 1000 surgical procedures involving Level II sedation. At 8:40 a.m., Nurse Huff administered 2.5 mg of Versed, 0.2 mg of Robinul, and 1.0 g of Ancef. At 8:45 a.m., Nurse Huff started the oxygen, nitrous oxide, and Diprivan drip. The oxygen was in a two-liter bottle, and the nitrous oxide was in a four-liter bottle. The Diprivan was 500 mg in a 500 cc solution. During the surgery, Nurse Huff administered all of this Diprivan, as well as all of another 200 mg of Diprivan in a 250 cc solution, given S. B.'s resistance to sedation. In most cases, and probably in this one, Respondent uses a microchamber, which releases microdrips at the rate of 60 drops per minute. Respondent does not administer Diprivan by means of an infusion pump, which would offer more precise control of the rate of infusion. The records do not indicate the rate of administration of the Diprivan. However, Respondent rarely finds it necessary to discontinue Diprivan during surgery, and its clinical effect wears off after only about three minutes following its discontinuation, so the patient arouses quickly after Diprivan is stopped. Thus, the failure to record the rate of administration of the Diprivan is immaterial. At 8:45 a.m., Nurse Huff also administered 100 mg of fentanyl, which was followed by 50 mg doses at 8:50 a.m., 8:55 a.m., 9:05 a.m., 9:35 a.m., 9:45 a.m., 10:05 a.m., and 10:10 a.m. S. B. thus received a total of 450 mg of fentanyl. The surgery commenced at 9:30 a.m. At the start of surgery, Respondent administered subcutaneously at the surgical site 150 cc of one percent lidocaine, which is a local anesthetic, with epinephrine at 1/200,000. The epinephrine prevents the body from quickly absorbing the lidocaine. S. B.'s blood pressure had varied between 8:40 a.m. and 9:30 a.m. It started at 164/97, but was 135/85 15 minutes later. Her blood pressure remained at 145/85 from 9:00 a.m. to 9:10 a.m. At the time of surgery, S. B.'s blood pressure was 162/88. In response to the start of surgery and reflective of S. B.'s level of anxiety, her blood pressure surged to 180/95 at 9:45 a.m., and Respondent directed Nurse Huff to administer 2.5 mg of labetalol at this time. S. B.'s blood pressure reached 190/80 at 10:00 a.m., five minutes after Nurse Huff had administered another 2.5 mg of labetalol. By 10:10 a.m., S. B.'s blood pressure was down to 125/75, where it remained for the remainder of the surgery. S. B.'s other vitals remained good during the surgery. Oxygenation saturation remained over 96 percent, mostly 97 and 98 percent. Respiration remained around 18. Pulse ran in proportion to blood pressure, but settled within the range of 80-90 once S. B.'s blood pressure stabilized at 10:10 a.m. Blood loss was minimal during the surgery. Typically, a patient may lose 200-300 cc of blood, but S. B. lost only 150 cc. Proceeding conservatively, Respondent did not try to tighten the muscle wall, as he found, once he had made the incisions, that S. B. did not require this procedure. The liposuction removed 200 cc, including 150 cc of fat. Anesthesia ended at 11:05 a.m., and surgery ended at 11:10 a.m. During the surgery, S. B. had received 2000 cc of fluids. At all times, S. B. remained active and alert. Evidencing S. B.'s level of alertness during surgery was her high oxygen levels at all times during surgery and the necessity of additional Diprivan. At 11:20 a.m., S. B. was transported by stretcher from the operating room to the recovery room. At this time, her oxygen level was 98 percent, her blood pressure was 179/97, her pulse was 96, and her respiration was 16. At 11:30 a.m., S. B. received 2.5 mg of labetalol. At 11:35 a.m., S. B. was complaining of anxiety, so she received 2.5 mg of Valium. At 11:40 a.m., a nurse emptied her Foley catheter of 1600 cc of clear yellow urine. At this time, S. B.'s blood pressure was 184/105, her pulse was 95, her respiration was 16, and her oxygen level was 96 percent. She received another 2.5 mg of labetalol. At 11:45 a.m., S. B. received another 2.5 mg of Valium. At 12:15 p.m., S. B.'s blood pressure was 164/92, and she received clonidine 0.1 mg to reduce her blood pressure. Fifteen minutes later, S. B.'s blood pressure dropped to 143/88. She fell asleep at 1:00 p.m., but awoke an hour later, complaining of pain. She then received 75 mg of Demerol with 6.25 mg of Phenergan, which controls nausea. At 2:30 p.m., S. B. complained again of pain. Her blood pressure had risen to 189/78, so she received another clonidine 0.1 mg. Fifteen minutes later, a nurse emptied S. B.'s Foley catheter of 1400 cc of clear urine. S. B.'s blood pressure was 170/100, and the nurse notified Respondent of this reading. The nurse gave S. B. 10 mg of Procardia, which reduces high blood pressure. At 3:00 p.m., S. B. received 2.5 mg of labetalol and 2.5 mg of Versed. Fifteen minutes later, S. B. was transferred by stretcher to the overnight room with a blood pressure of 141/60, pulse of 96, and respiration of 16. By 3:45 p.m., S. B.'s blood pressure was 125/59, and she was asleep. Thirty minutes later, S. B. was watching television, and her blood pressure was 141/78. After complaining of pain, S. B. received 100 mg of Demerol with 12.5 mg of Phenergan at 4:50 p.m. At 5:10 p.m., S. B.'s blood pressure rose to 163/94, and her pulse was 108. She received another 10 mg of Procardia at this time. At 6:00 p.m., S. B.'s blood pressure was down to 142/88. Two hours later, after she complained of insomnia, S. B. received 30 mg of Restoril. At 9:15 p.m., S. B. complained of abdominal pain. She received 100 mg of Demerol and 25 mg of Phenergan. At 11:30 p.m., S. B. received 30 mg of Restoril for insomnia and 10 mg of Lorcet for pain. At 1:20 a.m. on January 16, S. B. was sleepy. Two hours later, her blood pressure was 148/70. At 5:30 a.m., after an uneventful night, S. B. complained of abdominal pain and received another 10 mg of Lorcet. At 7:00 a.m., her intravenous line was discontinued. Alert and oriented, S. B. walked in the hall and received another clonidine 0.1 mg. A nurse emptied her Foley catheter of 400 cc of urine and removed the Foley catheter. At discharge at 8:00 a.m., Respondent examined the wound and found no evidence of bleeding, as he changed the dressing. At this time, S. B.'s blood pressure was 147/70 and pulse was 108. S. B. was transported by wheelchair to her daughter's car. S. B. and her daughter arrived at S. B.'s home at about 9:00 a.m. on January 16, 2004. After spending the morning with her mother, the daughter left the home and returned at 1:00 p.m. Having forgotten the house key, the daughter knocked on the door, and S. B. had to crawl to the door due to her lack of strength. The daughter assisted her mother to bed. Mid- afternoon, the daughter left her mother to run some errands. When the daughter returned home shortly before 6:00 p.m., she found her mother unresponsive and curled into a fetal position on the floor with blood present on the bed sheets and nightshirt that she was wearing. The daughter immediately called 911 and requested an ambulance. The emergency management technicians (EMTs) arrived at S. B.'s home at 6:23 p.m. and found her as her daughter had found her. S. B. was in full cardiac arrest. The EMTs found S. B. cold to the touch with fixed and dilated pupils. They found a "small amount" of blood oozing from the staples in the lower stomach. The two surgical drains in the upper stomach contained no discharge. Blood had soaked the bandage and run down both legs to thigh level. The EMTs estimated blood loss at about 500 cc. The EMTs also found the Restoril and Lorcet in the doses that Respondent had prescribed pre-operatively. The EMTs attempted unsuccessfully to resuscitate S. B. and transported her to the hospital where she was pronounced dead on arrival at 6:35 p.m. The medical examiner conducted an autopsy on January 17, 2004, at which time blood and urine samples were taken for toxicological analysis. The toxicology report notes that a gas chromatography/mass spectrometry procedure revealed the presence of 6-MAM, which is a metabolite of heroin and demonstrates conclusively that S. B. consumed heroin or, much less likely, 6-MAM; morphine, which is another indicator of heroin, at a concentration of 0.22mg/L; methadone at a concentration of less than 0.05 mg/L; meperidine, which is Demerol (a narcotic analgesic) at a near-toxic concentration of 0.98 mg/L; diazepam, which is Valium, at a concentration of less than 0.05 mg/L; nordiazepam, which is a metabolite of Valium, at a concentration of less than 0.05 mg/L; temazepam, which is, as noted above, Restoril or another metabolite of diazepam, at a concentration of 0.29 mg/L; and hydrocodone, which is one of the two ingredients, as noted above, of Lorcet, at a concentration of 0.05 mg/L. A drug's half-life is the amount of time for its potency to be reduced by half. Three to four half-lives are required for the complete elimination of a drug. Because various conditions can affect the half-lives of drugs, such as liver disease as to drugs eliminated substantially through metabolism by the liver, half-lives are stated as average ranges. Relevant half-lives are: Demerol--2-24 hours; diazepam--21-37 hours; hydrocodone--3.4-8.8 hours; and temazepam--3-13 hours. Diprivan and fentanyl have very short half-lives and were not detected by the toxicologist. The half- life of 6-MAM is also very short, about 6-25 minutes, leading the toxicologist who performed the report for the medical examiner to testify that S. B. had consumed heroin not more than two hours before her death. The same toxicologist testified that the detected concentration of Demerol was six times the therapeutic level. (This testimony is credited over the testimony of the Deputy Chief Medical Examiner that the concentration of 0.98 mg/L is only twice the therapeutic level.) Given a half-life of 2-24 hours, all that can be said with certainty is that S. B. suffered even greater concentrations of Demerol--possibly much greater--prior to the near-toxic concentration found by the toxicologist. Undoubtedly, the heroin and methadone that S. B. consumed were not prescribed by Respondent. Undoubtedly, S. B. had access to Demerol that Respondent had not administered. Respondent could not have reasonably have anticipated, based on the circumstances, that S. B. would consume heroin, methadone, and toxic or near-toxic amounts of Demerol, in addition to her prescribed medications, within 12 hours of her release from the Cosmetic Surgery Center. Just as an illegal drug user has the right to treatment in accordance with the applicable standard of care, so a physician has a right to expect behavior on the part of his patient that is at least consistent with the instinct of self-preservation. The autopsy determined that S. B. died of a combined drug overdose of heroin, temazepam, Valium, methadone, Demerol, and hydrocodone. Contributing causes of death were hypertension, abdominal wall hemorrhage, and cirrhosis. As to the hypertension, the autopsy report states that S. B. suffered from mild arteriosclerotic cardiovascular disease. As to the abdominal wall hemorrhage, the autopsy report states that S. B. was in status--post-tummy tuck and liposuction. As to the cirrhosis, the autopsy report states that S. B. suffered from severe fatty metamorphosis of the liver. The autopsy report concludes that the manner of death was an accident. Of the drugs that combined to kill S. B., Respondent clearly did not administer or prescribe the heroin or methadone. Although Respondent administered Demerol at the dosages of 75 mg at 2:00 p.m. 100 mg at 4:50 p.m., and 100 mg at 9:15 p.m., all on January 15, the near-toxic Demerol found in S. B. at the time of her death was not due to these doses, but due, at least in large part, to Demerol that S. B. obtained from other sources. The hydrocodone and temazepam were probably derived, at least in part, from the Lorcet and Restoril that Respondent prescribed for post-operative use. Unfortunately, the record does not reveal how many pills of each that the EMTs found at the S. B.'s home, so it is impossible even to infer how much of each medication that S. B. took while at home during the afternoon of January 16 immediately preceding her death. Not much hydrocodone was found in S. B., and the 10 mg of Lorcet given at 11:30 p.m. on January 15 and 10 mg of Lorcet given at 5:30 a.m. on January 16 would have been nearly eliminated by the time of S. B.'s death, given the short half-life of hydrocodone. Considerably more temazepam was found in S. B., but the 30 mg of Restoril given at 8:00 p.m. and 30 mg of Restoril given at 11:30 p.m. would have been nearly eliminated by the time of S. B.'s death, given the short half-life of temazepam. Clearly, in the two or three hours before she died, S. B. took heroin, methadone, and Demerol. Clearly, the fentanyl that she had last received at 10:10 a.m. on the prior day and the Diprivan that she had last received at 11:05 a.m. on the prior day had long cleared her system before she took the heroin, methadone, and Demerol. S. B. accidentally took her own life by taking these three drugs. The record does not suggest that hemorrhaging from the surgical site was due to some failure on Respondent's part. Instead, it appears more likely that falling from the bed or possibly convulsing from the drug overdose, S. B. may have reopened the incision site. The record does not suggest that cirrhosis materially extended the half-lives of any medications that Respondent administered. S. B. efficiently eliminated the Valium that Respondent administered. The record does not explain why she would not as efficiently eliminate other drugs metabolized primarily by the liver. The record does not suggest that Respondent's management of S. B.'s hypertension intra- and post-operatively had any bearing on her demise. Her blood pressure stabilized late in the afternoon of January 15, and nothing in the record suggests that anything that transpired on that day concerning S. B.'s hypertension caused an acute crisis that resulted in her death. As to Count I, Respondent did not depart from the applicable standard of care. S. B. never fell below Level II sedation; she was always responsive to pain and attempts to communicate. S. B. proved difficult to sedate even to Level II. On these facts, it is impossible to find even that it was reasonably likely, at the outset of the procedure, that S. B. would reach Level III sedation. Additionally, as to Count I, Respondent competently managed S. B.'s hypertension intra- and post-operatively. Based on the circumstances, Respondent correctly determined that the slight elevation of PT would not interfere with clotting or endanger the patient's safety and correctly determined that the other five slight abnormalities in the lab report were immaterial to patient safety in the contemplated surgical procedure. Respondent was thus not required to obtain additional tests or to obtain a consultation for the slight PT abnormality. Based on the physical examination and lab results, including those ordered by the primary care physician, insufficient evidence of liver abnormality existed to preclude the administration of the acetaminophen contained in Lorcet. Further, the standard of care does not preclude the prescription of acetaminophen to all patients with any kind of liver disease. As to Count II, Respondent's medical records fail to document adequately why he proceeded to operate despite S. B.'s failure, pre-operatively, to reach a blood pressure of less than 150/90, why he administered vitamin K pre-operatively, and, most importantly, how he had assimilated the PT abnormality in his treatment plan for S. B. As noted above, at hearing, Respondent amply supplied all of this information--the problem is that he never bothered to do so in the medical records. Although these deficiencies in medical records did not contribute in any way to S. B.'s death, they are material failures to justify the course of treatment. In contrast to the detailed records of Nurse Huff intra-operatively and the post-operative records prepared by nurses, Respondent's notes, and thus the records themselves, do not approach the minimum level of detail necessary to justify the course of treatment in this case. As to Count III, Respondent did not administer or cause to be administered excessive or inappropriate quantities of Diprivan. As to Count IV, Respondent did not improperly delegate professional duties, with respect to the administration of Diprivan, to a registered nurse who was not a CRNA. At all times, Respondent adequately supervised and monitored the administration of this short-acting sedative. The record does not support Respondent's claim of prejudice resulting from any delay in the prosecution of this case. Any claim of prejudice due to delay is undermined by Respondent's failure to demand an immediate hearing due to the imposition of an emergency restriction on his license.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order dismissing Counts I, III, and IV of the Administrative Complaint, finding Respondent guilty of a single violation of Section 458.331(1)(m), Florida Statutes, suspending his license for 30 days, placing his license on probation for two years, requiring him to complete successfully continuing medical education on medical records, and imposing an administrative fine of $10,000. DONE AND ENTERED this 25th day of August, 2006, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 2006. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin AO2 Tallahassee, Florida 32399-1701 John E. Terrel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Lewis W. Harper Brew and Harper, PL 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 George Kellen Brew Brew and Harper, P.L. 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 Patricia Nelson Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399
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 to be decided is whether disciplinary action should be taken against the Respondent's license as a medical doctor for the alleged violations of Chapter 458, Florida Statutes (1983), as set forth in the Administrative Complaints?
Findings Of Fact The Respondent is licensed as a medical doctor with the State of Florida, Board of Medical Examiners. The license, Number 28366, was first issued on February 11, 1976. The Respondent was licensed at all times relevant to this proceeding. October 5, 1983 Complaint. On or about July 7, 1982, the State Attorney of the Eleventh Judicial Circuit filed a ten (10) count Information against the Respondent. In the information it was alleged that the Respondent knowingly and unlawfully filed, attempted to file or aided and abetted in the filing of claims for services to recipients of state or federally funded assistance program benefits (the Florida Medicaid Program) in violation of Section 409.325, Florida Statutes. The services, according to the Information, were never rendered. On April 18, 1983, the State of Florida nolle prossed Counts 3 and 4 of the Information. On June 30, 1983, the State nolle prossed Counts 1, 2, 5, 7 and 9. The same day, the Respondent withdrew his original plea and plead guilt to the remaining counts: 6, 8 and 10 of the Information. As a result of the Respondent's guilty plea, he was found guilty on counts 6, 8 and 10 and adjudication was withheld. The Respondent was placed on probation for one (1) year and was required to repay $3,500.00 to the Florida Medicaid Program. The Respondent completed his probation, which was terminated early by the court, and made restitution to the Florida Medicaid Program. The Respondent stipulated that he plead guilty to Counts 6, 8 and 10 of the Information, that adjudication ways withheld and that the case was disposed of in the manner described above. According to the Respondent, he plead guilty on the advice of this counsel and as a matter of convenience (to himself and not "to all parties" as suggested by the Respondent in his proposed findings of fact). He did so despite his belief that he was not guilty. The Respondent's proposed finding of fact that his attorney never advised him that he could be in violation of Section 458.331(1)(c), Florida Statutes, irrelevant. July 27, 1983 Complaint. On March 24, 1981, the Respondent saw Ana Gonzalez as a patient in his office. Ms. Gonzalez was thirteen years old at the time of her first visit (Ms. Gonzalez's date of birth was incorrectly listed as "8-7-82" in the Respondent's records). Ms. Gonzalez, according to the Respondent's record of Ms. Gonzalez's visits (hereinafter referred to as the "Patient Records") complained of "pain of mild intensity on lower left quadrand [sic], inradiating [sic] to right lower quadrant and left lumbar fossa." The Patient Records, which were all in the same handwriting, 1/ also indicate that Ms. Gonzalez had low back pain, dark urine which looked like blood and a fever of 100.4 degrees. A physical examination of Ms. Gonzalez found nothing abnormal except pain in both lower quadrants of the abdomen and the left lumbar fossa of the back. The Respondent made a probable diagnosis of pyelonephritis and ordered a SMAC 26, a Complete Blood Count ("C.B.C."), an urinalysis, an E.K.G. and a chest x-ray. The Petitioner has proposed a finding of fact that the chest x-ray and the E.K.G. were not referred to in the Patient Records. This proposed finding is incorrect. The Respondent did, however, order a kidney, urethra and bladder x-ray ("K.U.B.") which was not recorded in the Patient Records. The Respondent also prescribed an antibiotic. The results of the E.K.G. and the chest x-ray are not noted in the Patient Records; nor does the E.K.G. print-out include any findings. The SMAC 26 showed nothing abnormal. The C.B.C. also showed nothing abnormal and the K.U.B. was negative. Finally, the urinalysis showed that the patient's urine was yellow, clear and contained no blood. The charges for the first visit were $30.00 for the examination, $182.00 for the SMAC 26 (charged at $7.00 per 26 procedures), $6.00 for the urinalysis, $10.00 for the C.B.C., $40.00 for the chest x-ray and $40.00 for the E.K.G. No charge was made for the K.U.B. The patient was next seen by the Respondent on March 31, 1981 (erroneously reported as March 31, 1982 in the Patient Records). The Petitioner's proposed finding of fact that the Patient Records were kept in the same pen is therefore incorrect. The Patient Records indicate the following: "The patient is feeling a little better of pain. No fever. Persist urine dark." The Patient Records do not indicate that Ms. Gonzalez was examined on this visit. The Respondent continued the antibiotic and ordered the following tests: a C.B.C., a K.U.B. and an intravenous pyelogram ("I.V.P."). The I.V.P. was reported as negative in the Patient Records. The C.B.C. again found no abnormalities. The K.U.B., as testified to by the Respondent, was also negative. The Respondent testified that he ordered another K.U.B. on this visit because he again found blood in the patient's urine and because he believed that you can never tell when a test will result in a positive finding. The Petitioner has proposed the following finding of fact with regard to the March 31, 1981 visit: Again, the tests results obtained from the laboratory show that the urine is not discolored and that the urine does not contain blood, in contradiction with the handwritten medical record of the Respondent. Although this proposed finding is correct with regard to tests performed on the March 24, 1981 visit, no urine test was performed on the March 31, 1981 visit. The charges for the March 31, 1981, visit included $30.00 for the examination, $10.00 for the C.B.C., $40.00 for the K.U.B. and $80.00 for the I.V.P. The third visit by Ms. Gonzalez was on April 7, 1981. On this visit, Ms. Gonzalez was feeling much better (the "pain was very mild"), but the Respondent determined there was still blood in her urine. The Patient Records again do not indicate the results of any physical examination. The Respondent ordered an urinalysis which found that her urine was yellow. Although the Respondent testified in his deposition that the Patient Records for the April 7, 1981 visit were complete, billing records show that a charge for an I.V.P. was made for April 7, 1981 which was not recorded in the Patient Records. The Respondent admitted in his deposition that no I.V.P. was performed and stated that the charge for $80.00 was a mistake. The Respondent stated that he did perform a K.U.B. or I.V.P. on this visit because it was too soon after the last K.U.B. and I.V.P. tests. Instead of an I.V.P., the Respondent testified in his deposition that Ms. Gonzalez received physiotherapy for which she should have been charged only $20.00. The physiotherapy was ordered because of the patient's complaints of lower back pain and consisted of heat treatment/ultrasound. Petitioner, in its proposed findings of fact, indicates that the Respondent took Ms. Gonzalez, off the antibiotic he had prescribed earlier at the April 7, 1981 visit, citing "(Depo., page 20)." This proposed finding is not supported by the record. Other charges for the April 7, 1981, visit included $30.00 for the examination and $6.00 for the urinalysis. The next visit by Ms. Gonzalez was on April 14, 1981. The Patient Records do not indicate Ms. Gonzalez's condition or that an examination was performed. The Patient Records only indicate that the Respondent suggested hospitalization of Ms. Gonzalez so that more tests could be made and that her father refused. The Respondent ordered a K.U.B. (which was negative) and a SMAC 26 (which found no abnormalities). The antibiotic was also changed. The charges for this visit included $30.00 for the visit, $40.00 for the K.U.B. and $182.00 ($7.00 per 26 procedures) for the SMAC 26. Again the bill included a charge of $80.00 for an I.V.P. which, according to the Respondent, was a mistake in billing. The Respondent actually performed physiotherapy which should have resulted in a $20.00 charge. The final visit occurred on April 20, 1981. The Patient Records for this visit indicated the following: I insisted some UROLOGY must consultate this patient and she refused to see another Doctor and culture and sensitivity. She says she does not want to go to the rest room. She decides pick up the urine. I decide another I.V.P. because persist a mild hematuria [blood]. Mr. Gonzalez again refused to admit his daughter to a hospital as suggested by Respondent. The Respondent recommended hospitalization because his tests were not finding anything and he therefore wanted to run a kidney scan. There is no indication in the Patient Records as to whether an examination was performed. The Respondent ordered a K.U.B., an I.V.P. and a C.B.C. The results of these tests are not recorded in the Patient Records but the Respondent has testified that they were negative. On this visit the Respondent indicated his diagnosis was pyelonephritis, which he described as "kidney infection." Charges for this visit were $30.00 for the examination, $40.00 for the K.U.B., $80.00 for the I.V.P. and $10.00 for the C.B.C. Pyelonephritis is an inflammatory reaction of the kidney involving the kidney tissue and the pelvis of the kidney. It is usually accompanied by severe toxicity, a temperature for a child the age of Ms. Gonzalez of 104 to 105 degrees and extreme chills. It is a serious infection. The diagnosis of pyelonephritis on March 24, 1981 and April 20, 1981, by the Respondent was not medically justified. Ms. Gonzalez did not have any of the symptoms normally associated with pyelonephritis. The results of all of the tests performed by the laboratory 2/ and the Respondent were negative. Laboratory test results conclusively showed that Ms. Gonzalez's urine was yellow, and contained no blood. Additionally, the Respondent should have performed a urine culture, a blood culture and a sensitivity test before concluding that the patient was suffering from pyelonephritis. The cultures would have determined if there was an organism present and, if so, what type. The sensitivity test would have shown what the organism was sensitive to. None of these tests were performed. Most of the tests ordered by the Respondent were also not medically justified. The only tests which were clearly medically justified were the SMAC 26, C.B.C. and the urinalysis ordered on March 24, 1981. Most of the remaining tests were not medically justified as hereinafter discussed. The E.K.G. performed by the Respondent on March 24, 1981, was not medically justified. The Respondent indicated that he ordered an E.K.G. because he was looking for valvular problems with Ms. Gonzalez's heart. An E.K.G., however, only, shows the electrical activity of the heart. The Respondent also testified that the E.K.G. was performed because he suspected a kidney problem. According to the Respondent, if there was a problem with Ms. Gonzalez's kidneys, it could have affected her E.K.G., especially in light of her age. No problem was found according to the Respondent. The chest x-ray performed on the March 24, 1981 visit was not medically justified. This test resulted in exposure of Ms. Gonzalez to x-rays which could be harmful to her. The Respondent, based upon his deposition testimony, believes that a chest x-ray should be taken of anyone who comes to his office as a patient and has insurance. With regard to Ms. Gonzalez, he indicated that her parents requested the chest x-ray but admitted there was no medical cause for her to receive a chest x-ray. The K.U.B. tests performed on March 24, 1981, March 31, 1981, April 14, 1981 and April 20, 1981 and the I.V.P. tests performed on March 31, 1981 and April 20, 1981 were not medically justified. These tests also resulted in exposure of Ms. Gonzalez to x-rays which could be harmful to her; especially the I.V.P. test which has six to seven times the radiation level of a K.U.B. The I.V.P. was also a dangerous procedure because it is an invasion procedure (the introduction of a foreign substance to the body). Even the Respondent must have realized the possible problem with the I.V.P. since he indicated that this test was not performed on April 7, 1981, because it was too soon after the test performed on March 31, 1981. The second SMAC 26 test, performed on April 14, 1981 was not medically justified. The test, according to the Respondent, was performed because the blood in Ms. Gonzalez's urine persisted. The evidence clearly shows that there was no blood in her urine, however. A SMAC 26 is a single laboratory procedure whereby one blood sample is divided into 26 parts (or some other number of parts) which are diagnosed or read by a machine at the same time. It is not 26 separate tests; it is a single automated test. The method by which the Respondent billed for the SMAC 26 tests performed on March 24, 1981 and April 14, 1981, (charging $7.00 for each of 26 tests) was not justified. The Respondent billed for the S4AC 26, which gas performed by Central Medical Laboratory, because he believed that the insurance company would pay what he hoped to receive for the test: $60.00-$80.00. If he had only billed $60.00 for the test he stated that he would only have received $6.00 to $10.00 from the insurance company. The Petitioner has proposed a finding that the SMAC 26 billing was "outrageously high." The evidence supports a finding that the charge was excessive. Finally, the C.B.C. tests of March 31 1981 and April `20, 1981 and the physiotherapy performed on April 7, 1981 and April 14, 1981 were not medically justified. Dr. Handwerker's testimony was consistent with the findings in this Recommended Order with regard to the lack of medical justification for most of the tests. The Respondent stated that he agreed in part and disagreed in part with Dr. Handwerker's testimony. When asked to identify those areas of Dr. Handwerker's testimony he disagreed with, the Respondent unsuccessfully attempted to rebut Dr. Handwerker's testimony with regard to the E.K.G. and chest x-ray and with the fact that the tests were repeated to often. 3/ The Respondent did not attempt to rebut any other part of Dr. Handwerker's testimony, which was based upon his examination of the Patient Records and the Respondent's deposition (she did not examine Ms. Gonzalez). Based upon the foregoing, it is clear that the Respondent failed to practice medicine in conformance with the generally accepted and prevailing standards of medicine in the medical community. The Respondent also failed to, practice medicine with the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar circumstances and conditions. The father of Ms. Gonzalez testified on behalf of the Respondent. Mr. Gonzalez stated that he was satisfied with the Respondent's medical care of the Gonzalez family and that he would continue to retain the Respondent. Letters submitted by the Respondent also indicated that friends, associates and his pastor believe the Respondent is honest, experienced, qualified and of high moral and ethical standards. Although the Respondent testified that he had done the best he could do for Ms. Gonzalez, the unrebutted testimony supports a conclusion that his best was not good enough. Finally, the Respondent's testimony to the effect that he had not intended to exercise influence over Ms. Gonzalez or to deceive her in his medical treatment of her is not believable in light of the facts.
Recommendation Based on the foregoing Findings of Fact and Conclusions RECOMMENDED: That Respondent be found guilty of violating Section 458.331(1)(c), Florida Statutes (1983), by being found guilty, regardless of adjudication, of a crime in any jurisdiction which directly relates to the practice of medicine or to the ability to practice medicine. It is further RECOMMENDED: That Respondents be found guilty of violating Section 458.331(1)(l), Florida Statutes (1983), by employing a trick or scheme in the practice of medicine when such scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community. It is further RECOMMENDED: That Respondent be found guilty of violating Section 458.331(1)(o), Florida Statutes (1983), by exercising influence on a patient or client in such a manner as to exploit the patient or client for financial gain of himself, as a licensee. It is further RECOMMENDED: That Respondent be found guilty of violating Section 458.331(1)(t), Florida Statutes (1983), by failing 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. It is further RECOMMENDED: That the Respondent's medical license be suspended for a period of one (1) year and that the Respondent be placed on probation for a period of three (3) years, upon reinstatement of his license, subject to such conditions and terms of monitoring and continuing medical education as may then be prescribed by the Board of Medical Examiners. DONE and ORDERED this 22nd day of February, 1985, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 FILED with the Clerk of the Division of Administrative Hearings this 22nd day of February, 1985.
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 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 Whether the Petitioner's performance on the podiatry examination was misgraded, so that he should be licensed?
Findings Of Fact Mr. Wolansky took the podiatry licensure examination in July of 1988. He received a score of 73.8 (he answered 266 items correctly); a score of 75 is required to pass (correct on 270 items). If Petitioner obtains credit for four more correct answers, he would pass the examination. Wolansky challenges the grading of nine questions. These are AM #1; PM #5; PM #30; PM #7; AM #92; AM #19; AM #191; PM #114, and PM #59. The general instructions given during examination to the examinees included the following: To answer the questions: . . . from those choices presented, select the choice that you judge as the correct answer to the question. . The first question at issue is AM #1 which stated: The sesamoid bone that must be differentiated from a fracture of the styloid process at the base of the fifth metatarsal is the os The four choices given were: trigonum vesaleum peroneum tibialis exterior The Department maintains the correct answer is (B) vesaleum. Dr. Marianne Bouvier, an Assistant Professor of Cell Biology and Anatomy at the University of Miami School of Medicine testified on behalf of Dr. Wolansky that the available choices contain no correct answer. There is a recognized distinction in text books on human anatomy between accessory bones and sesamoid bones. These classes of bones are mutually exclusive. There is, therefore, no correct answer available. The testimony offered by Dr. Chester A. Evans, who is Dean and Professor of Podiatric Surgery at Barry University School of Podiatric Medicine, is that vesaleum is the correct answer, and that sesamoid and accessory bones are the same. The testimony of Dr. Bouvier is more persuasive. The question had no correct answer and therefore should not be used in determining the outcome of the examination. Question PM #5 asked: Which of the following changes contributes to the oxygen debt that occurs during exercise? a decrease in the arteriovenous oxygen concentration difference a rise in the concentration of oxygen in the lungs a decrease in the concentration of hemoglobin an increase in lactic acid concentration Dr. Wolansky chose (C) as his answer. The Board regards (D) as the correct answer. Dr. David Landowne, an Associate Professor in Physiology and Biophysics at the University of Miami School of Medicine, testified that no correct answer is available. The Board's answer is incorrect because lactic acid concentration does not contribute to oxygen debt, but is rather the result of oxygen debt. The answer reverses causality, and is incorrect. While Dr. Wolansky does not contend that his answer is correct, no correct answer was offered as a choice. Dr. Evans' testimony that the Board's answer is the best of the answers available is unpersuasive. All answers are wrong and this question should not be considered at accessing Dr. Wolansky's performance. Question PM #30 asks: A systolic blood pressure below is usually considered to be of potential serious level. The four choices given were: (A) 100 90 80 70 Dr. Wolansky answered (C); the Department regards the correct answer as (D). The Department relies upon an article in Podiatry Quarterly published in 1965 in support of its answer (that publication is now known as The Journal of Podiatric Medicine) Dr. Landowne testified that according to medical publications, such as Current Medical Diagnoses and Treatment, published by Lange Medical Publications, and others, a systolic blood pressure below 80 would be regarded as shock, and is a serious condition. The question does not require an examinee to answer the question according to some undisclosed text, but according to current medical knowledge. The answer provided by Dr. Wolansky of 80 is a correct answer, and he should be given credit for that answer. Dr. Wolansky next disputes the scoring of question PM #7 which asks: Which of the following causes abnormal dynamics at the capillary membrane, resulting in edema? the kidney stops the retension of fluid high colloid osmotic pressure decreased plasma protein increased plasma protein Dr. Wolansky answered (B); the Department regards the correct answer as (C). Edema is the flow of water from the blood vessel into tissue spaces. It occurs where there is an imbalance of osmotic pressure across a capillary wall. Decreased plasma protein would cause an imbalance, but as Dr. Landowne pointed out, high colloid osmotic pressure outside the capillary would also cause an imbalance. The question does not say where the osmotic pressure is, or what it is high in relationship to. Dr. Evans merely recounted a source which the Department relied upon to support its answer, but the testimony of Dr. Landowne that the source could support either answer is more persuasive. Dr. Wolansky's answer to the question should be regarded as correct. Question AM #92 asks: Type one classification of Salter-Harris growth plate injuries includes? The four choices given were: separation of epiphysis from metaphysis the growth place is crushed, involving adjacent structures line of fracture includes the joint line of fracture passes through the growth plate Dr. Wolansky answered (D); the Department regards the correct answer as (A). Dr. Wolansky presented the testimony of Dr. John Levin, a podiatrist, that both answers are correct. All Salter- Harris injuries are injuries to the growth plate, that is they are fractures which pass through the epiphyseal growth plate, so that separation of the epiphysis from the metaphysis occurs in Salter-Harris injuries types 1-4. The type 1 Salter-Harris injury includes both separation of the epiphysis from the metaphysis as well as the line of fracture passing through the growth plate. Because of the particular wording of the question, viz; " . . . of Salter-Harris growth plate . . ." the answer probably should be limited to injuries to the growth plate so that Dr. Wolansky's answer is more correct. The testimony of Dr. Levin is persuasive, and the answer given by Dr. Wolansky should be regarded as a correct answer. Dr. Wolansky next challenges the grading of question AM #191 which states: A patient who presents with red to cyanotic discoloration of the digits is said to exhibit? dependent rubor cold feet elevational ischemia abnormal venous filling time capillary fragility Dr. Wolansky answered (D); the Department regards the correct answer as (A). Dependent rubor describes an insufficiency in arterial circulation. This same problem can be exhibited by patients who have problems not with arteries, but with veins, either due to dilation of the veins, or to incompetent valves in the veins which can also result in cyanotic discoloration. The question is sufficiently vague that either answer can be considered correct, and Dr. Wolansky should be given credit for his answer. Dr. Wolansky next challenges the answer to question PM #114, which asks: The local anesthetic action of lidocaine would be increased by? The four choices given were: a decrease in local pH such as accompanies infection or inflammation coadministration with epinephrine presence of aneuroma at the site of a nerve block none of the above Dr. Wolansky answered (D); the Department regards the correct answer as (B). The local anesthetic action of lidocaine is not increased by coadministration of epinephrine. While the use of epinephrine with lidocaine will prolong the anesthesia, it will not increase the effect of the lidocaine. The language of the question stem referring to increasing action asks the examinee to evaluate the intensity of the effect of the coadministration of the drugs, as opposed to a prolongation of the effect of the lidocaine. The answer given by Dr. Wolansky is correct. On balance, the testimony provided by the experts for Dr. Wolansky, Drs. Bouvier, Landowne and Levin, were significantly more persuasive. Drs. Bouvier and Landowne are professors at the University of Miami Medical School, with Ph.D. degrees in their fields, and were able to clearly discuss the implications of the answers offered to the candidates. Dr. Evans, in general, limited his testimony to identifying sources available somewhere in the professional literature which support the answer the Department regarded as correct. Dr. Wolansky had objected to questions AM #119 and PM #59, but adduced no testimony about it, and has not carried any burden of proof with respect to the scoring of those questions.
Recommendation Bennett L. Wolansky has established that he should be regarded as having received a passing grade on the July, 1988, examination for licensure as a podiatrist. Assuming that he meets the other qualifications for licensure (which were not as issue in this case) he should be licensed as a podiatrist in the State of Florida. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 13 day of February, 1990. WILLIAM R. DORSEY, JR. 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 13th day of February, 1990. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 89-1494 Rulings on proposed findings submitted by Dr. Wolansky: Adopted in finding of fact 1. Adopted in finding of fact 3. Adopted in finding of fact 4. Adopted in finding of fact 5. Adopted in finding of fact 6. Essentially adopted in finding of fact 7. Generally adopted in finding of fact 8. Generally adopted in finding of fact 9. Generally adopted in finding of fact 10. Rulings on proposed findings submitted by the Department of Professional Regulation, Board of Podiatry: Adopted in finding of fact 1. Adopted in finding of fact 1. Adopted in finding of fact 2. Generally adopted in the paragraphs dealing with the substantive questions. Generally adopted in finding of fact 4. Generally rejected for the reasons stated in finding of fact 4. Generally rejected for the reasons stated in finding of fact 5. Generally rejected for the reasons stated in finding of fact 6. Generally rejected for the reasons stated in finding of fact 7. Generally rejected for the reasons stated in finding of fact 8. Adopted in finding of fact 12. Generally rejected for the reasons stated in finding of fact 9. Generally rejected for the reasons stated in finding of fact 10. Adopted in finding of fact 12. COPIES FURNISHED: Donald J. Murray, Esquire 9200 South Dadeland Boulevard Suite 515 Miami, Florida 33156 E. Harper Field, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Patricia Guilford, Executive Director Department of Professional Regulation Board of Podiatric Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Kenneth E. Easley, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399
The Issue The issues to be determined in this proceeding are whether Respondent violated section 458.331(1)(t)1., Florida Statutes (2012), and if so, what penalties should be imposed.
Findings Of Fact Based upon the Stipulation of the parties and the evaluation of the evidence presented at hearing, the following facts are found: At all times material to the allegations in the Administrative Complaint, Respondent was a licensed medical doctor within the State of Florida and held license number ME 109501. Respondent’s address of record is 216 Elm Drive, Chattahoochee, Florida 32324. The Department presented no evidence of prior discipline against his license. In 2013, Respondent was under contract to furnish health care services to inmates at Suwannee Correctional Institution (SCI). This case involves the care and treatment for hypertension that Respondent provided to R.G. while R.G. was an inmate at SCI in June and July 2013. David Libert, M.D., who testified on behalf of the Department, is a Board-certified family practice physician who has been licensed in Florida since 1983. Dr. Libert sees patients in a clinical setting approximately three days a week but has never practiced in a correctional institution setting. Dr. Libert testified that a “perfect” blood pressure reading is 120/80. A reading that is under 140/90 is considered acceptable, but blood pressure that is consistently above 140/90 indicates hypertension. Malignant hypertension, or hypertensive emergency, is an acute elevation of blood pressure that is associated with end organ damage. End organ damage is the affect that the high blood pressure has on certain parts of the body, such as the brain, heart, and kidneys. The traditional benchmark reading that signals malignant hypertension is 180/120, which Dr. Libert testified is an arbitrary number but represents the “old” definition of the condition. According to Dr. Libert, newer studies define malignant hypertension as an acute rise on the height in blood pressure associated with end organ damage, even if the blood pressure reading does not go as high as the 180/120 measure recognized in older literature. The record is not clear when the change in definition took place, and if that change reflects the standard of practice in June 2013. Dr. Libert did not describe what constitutes an acute rise in blood pressure, either in terms of the length of time by which it is measured, or how much of a change in blood pressure constitutes an acute rise. The systolic reading is the top number in a blood pressure reading and represents the maximum pressure that is exerted on the arteries with the contraction of the heart. The diastolic reading represents the pressure after the heart has relaxed from its beat and is the lower number in a blood pressure reading. While 180/140 is the traditional reading identified as a signal for malignant hypertension in “older” literature, there was no testimony as to whether systolic and diastolic readings are equally important, or whether one is more important than the other when determining that a patient’s blood pressure is too high. In other words, no testimony was presented to answer the question of whether, for example a blood pressure reading of 185/96 or 170/133 would be considered a symptom of malignant hypertension. While there is no question both readings would indicate hypertension, the evidence did not indicate whether it is enough to have one of the two pressure readings above the 180/120 level to signal the possibility of malignant hypertension. The Department of Corrections has protocols for treatment of different systems of the body. The form for the Hypertension Protocol, which is included several times within R.G.’s medical records from Suwannee, includes several categories of information to be addressed by treating personnel, such as Subjective (which includes the patient’s chief complaint and current symptoms); Objective (which requires notation of vital signs, such as temperature, pulse, respiration, blood pressure, oxygen saturation and weight); Findings Requiring Immediate Clinician Notification; Plan; and Education. Under the heading “Findings Requiring Immediate Clinician Notification,” there are several factors that a health care provider (typically in this setting, a nurse) would check before the need to contact a physician arises. Those factors are blood pressure greater than 160/100 (see PLAN first); oxygen saturation less than 93 percent; heart rate less than 60 or greater than 110; wheezing (chest congestion); blurred vision; pedal edema extending to above the knees; severe headache OR headache not relieved after two hours of OTC pain med; or other. The PLAN portion of the protocol provides the following treatment alternatives: For mild to moderate headache give: Acetaminophen 325mg two tablets every 4-6 hours as needed for pain, OR Ibuprofen 200mg two tablets every 6 hours as needed for pain Put patient in a quiet environment; recheck blood pressure in 15 minutes x2. Notify clinician if BP remains greater than 160/100. 1st blood pressure recheck: / , at . 2nd blood pressure recheck: / , at . Bed rest lay-in x24 hours Blood pressure recheck in 24 hours Return to clinic for BP check Pass Other Respondent was responsible for patient R.G.’s medical care at SCI and had access to all of R.G.’s medical records from SCI’s medical clinic. R.G. was a 61-year-old male inmate who presented to the clinic at SCI for treatment. On or about June 7, 2013, R.G. presented to SCI’s clinic with a blood pressure reading of 164/96, and complaining of a headache. R.G. was given 10 mg Lisinopril to reduce his blood pressure, a pass for three days of bedrest, and a follow-up appointment for June 10, 2013. The medical record entitled Hypertension Protocol does not contain Respondent’s name and he did not see R.G. that day. However, from the Physician’s Order Sheet, it appears that he was consulted and approved the administration of Lisinopril, and prescribed 10 mg of Lisinopril daily for three months. On June 9, 2013, R.G. presented at the clinic complaining about his blood pressure. The medical record notes that he had a headache. His blood pressure reading was 151/90, and the section entitled Findings Requiring Immediate Clinician Notification did not have any symptoms checked. The medical record does not indicate that Respondent saw R.G. on June 9, 2013, and he was not consulted about his care. The PLAN section of the Hypertension Protocol says “No treatment required.” On June 10, 2013, it appears that R.G. may have been seen at the clinic more than once. The initial entry in his medical records for that date, which does not have a time recorded, indicates that his blood pressure was 158/98. The second entry, recorded at approximately 2:00 p.m., indicates that R.G. presented to the clinic with a blood pressure reading of 173/98. Respondent ordered a one-time dose of .2 mg Clonidine, and 10 mg of Lisinopril and directed that his blood pressure be taken again in an hour. Respondent tried to find the underlying cause for the rise in R.G.’s blood pressure by sending him for blood work, and a thyroid and cardiovascular evaluation by the cardiac clinic. Respondent also directed that his blood pressure be checked twice weekly for an indecipherable number of weeks. When R.G.’s blood pressure was rechecked at approximately 4:00 p.m., it was 158/89. Respondent again ordered administration of 10 mg Lisinopril, increased his prescription for Lisinopril to 20 mg for three months, and ordered 600 mg of Ibuprofen to treat R.G.’s headache. R.G. next presented to the clinic on June 11, 2013, at 10:00 a.m. At that time, his blood pressure was noted as 152/94. There is no indication in the medical record that Respondent saw R.G. during that visit, and there is no documentation in the Physician’s Order Sheet to indicate that Respondent ordered any prescriptions for him. On June 18, 2013, R.G. went to the clinic complaining of a headache and vomiting. He listed his pain level at 6 out of 10. At his initial presentation at noon, his blood pressure was 197/105 in the left arm, and 186/86 in the right. Under the PLAN heading, the medical record indicates R.G. was given 200mg Ibuprofen for his headache, and 0.2 mg of Conidine for blood pressure. His blood pressure was rechecked at 1:00 p.m. and had lowered to 139/84. The medical record for June 18, 2013, does not indicate that Dr. Alaka saw R.G. or that he was consulted about him. The Department of Corrections Physician Order Sheet for R.G. has an entry dated June 18, 2013, but part of the record is indecipherable, and there is no doctor Signature/stamp completed for the entry. In addition, the portion of the entry that is readable refers to a Dr. Gonzalez, as opposed to Dr. Alaka. On June 20, 2013, R.G. returned to the clinic, this time complaining that he was stumbling and had a headache. A protocol sheet for Neurological Changes/Deficits was used in the medical records as opposed to the Hypertension Protocol. At this visit, his blood pressure was 120/62. There is no indication on the medical record for this date that Dr. Alaka saw R.G. R.G. returned to the clinic on June 25, 2013, at 5:39 p.m. The medical record indicates that he had a slight headache, a small amount of pitting/extremity swelling, fatigue, and had vomited that morning. His blood pressure was 165/94 in the left arm and 175/91 in the right. Pedal edema was noted to stop at the mid to upper shins, and the records indicate that R.G. had slept only three hours or less in the previous 24-hour period. R.G. was given acetaminophen for his headache, and his blood pressure was rechecked at 5:59 p.m. and 6:15 p.m.. His blood pressure at the first recheck was 165/94, and at the second recheck was 164/93. The Hypertension Protocol indicates that R.G. was administered 10 mg of Lisinopril, was instructed to comply with all prescribed medications, and not to sit with his legs crossed. The Physician’s Order Sheet indicates that per Respondent’s discussion with the nurse who saw R.G.,1 the prescription for 20 mg of Lisinopril was discontinued and replaced with a prescription for the same drug at 10 mg daily for three months. There was speculation throughout the hearing that R.G. did not always take his medications as prescribed, and there are notations in the medical records that R.G. sometimes refused recommended medical treatments, such as a referral for a urologist and a cardiac workup. There was no clear and convincing evidence that R.G. was also failing to take his blood pressure medications as required, although it is certainly a possibility. There is no indication in the medical records that R.G. went to the clinic for treatment after June 25, 2013.2 On July 2, 2013, R.G. was found unresponsive on the floor. He was transferred to ShandsLiveOak Regional Medical Center, and from there, transferred to Jacksonville Memorial on 1 The Administrative Complaint alleges that R.G. was seen by an ARNP during this visit. The signature of the health care provider indicates that he or she was an SRN, not an ARNP. The ARNP who reviewed the records and made what was referred to as an incidental entry (one where the record is reviewed but the patient is not seen) the following day is a different provider. 2 There is an entry for June 28, 2013, entitled Pre-Special Housing Health Assessment. Dr. Alaka testified he did not know what that meant. It appears from the record that the purpose of the assessment was to extend R.G.’s low bunk pass. At that time, his blood pressure was recorded as 158/92. It is not clear who conducted the assessment. July 3, 2013. R.G. died on July 5, 2013. The Medical Examiner’s Report lists R.G.’s cause of death as hypertension. Dr. Libert reviewed the medical records related to R.G.’s treatment. He opined that Respondent did not meet the applicable standard of care in his care and treatment of R.G. because he did not arrange for transportation to the hospital on June 18, 2013. He also opined that Respondent should have transferred R.G. on later dates prior to the transfer that occurred on July 2, 2013. He further opined that Respondent failed to recognize the signs and symptoms of malignant hypertension and failed to diagnose it. Dr. Libert also testified that Respondent failed to order basic blood tests that should have been ordered for a patient with hypertension. However, as noted above, Respondent did order blood work on June 10, 2013. There is no indication in the medical records that Dr. Alaka saw R.G. on June 18, 2013. With respect to the June 25 visit, Dr. Alaka would have received a phone call from staff, but did not see R.G. in person. Dr. Alaka has no independent recollection of seeing R.G., and had to rely solely on his review of the medical records for his account of what happened. The treatment of this patient occurred over eight years prior to the hearing in this case. Dr. Alaka did not believe that treatment in a prison setting is the same as the treatment rendered in a typical outpatient setting, and testified that in an outpatient setting, physician groups are free to set their own protocols. In a correctional setting, physicians were required to follow the protocols established by the Department of Corrections. Dr. Alaka testified that following the protocols was a condition of employment. Dr. Alaka testified that he did not create or maintain the medical records for patients at the facility, but would have access to the records when treating a patient. It is not clear, however, whether he had access to the records when he was not at the facility but received a telephone call regarding the treatment of a patient. Based upon the medical records in evidence, Dr. Alaka saw R.G. on June 10; was consulted about R.G. on June 7 and June 25; and was neither present nor consulted regarding R.G. on June 9, June 11, June 18, and June 20, 2013. The only time that the medical records indicate R.G.’s blood pressure may have been above the standard of 180/120 for malignant hypertension was June 18, 2013, and when rechecked, the pressure went down to 139/84. As noted above, the medical records do not indicate that Dr. Alaka either saw R.G. or was consulted about his care on that day. On June 25, 2013, R.G.’s blood pressure, while still considered high, was well below the standard identified for consideration of malignant hypertension. Dr. Alaka also testified that one must always consider the possibility of malignant hypertension when taking a patient’s blood pressure, but did not believe R.G.’s blood pressure reached that level. He tried to prevent it through the use of medication but did not believe that you needed to transfer a patient because of swelling, vomiting, or headache combined with high blood pressure, because those symptoms can occur with a variety of conditions. In his view, there should be concrete blood pressure readings, with indications of organ disturbance or stress. Organ damage would be substantiated through blood work and treated with medication while waiting for results. If the blood pressure is sustained, then he would call his supervisor and report the blood pressure; that it is not coming down; what medications were given; and request a transfer. He testified he did not request a transfer in this case because the blood pressure came down with treatment. In addition, Dr. Alaka noted that blood pressure readings can vary within the same hour, depending on who took the reading, the size of the cuff used, operator error, etc. Dr. Alaka also testified, credibly, that transfers to facilities outside the prison setting required approval by the regional medical director, and that was a condition for working at SCI. The Department did not provide any evidence to rebut the statement that Respondent did not have the authority to order transfer out of the facility, or that following the protocols reflected in the medical records was not required for employment at the facility. Dr. Alaka’s view of what blood pressure reading would have triggered a diagnosis of malignant hypertension is higher than Dr. Libert’s. Based on the evidence presented, Dr. Libert’s definition appears to be more reasonable. However, based on the totality of the evidence presented, the Department did not present clear and convincing evidence to show that Respondent’s care and treatment of R.G. violated the prevailing standard of care as alleged in the Administrative Complaint.
Conclusions For Petitioner: Hunter M. Pattison, Esquire Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 For Respondent: Edmond Olatunde Alaka, M.D., pro se 216 Elm Drive Chattahoochee, Florida 32324
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against Respondent be dismissed. DONE AND ENTERED this 20th day of December, 2021, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2021. COPIES FURNISHED: Hunter M. Pattison, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Edmond Olatunde Alaka, M.D. 216 Elm Drive Chattahoochee, Florida 32324 Paul A. Vazquez, JD, Executive Director Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399
