The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed in the State of Florida and has been Board- certified in obstetrics and gynecology. On May 7, 1998, Patient A. J. underwent a laparoscopic procedure due to a complex left ovarian cyst at Columbia Surgical Park Center, an ambulatory care center located in Miami, Florida. The operation consisted of a laparoscopy with laparoscopic lysis of adhesions and a laparoscopic left ovarian cystectomy. Respondent performed the surgical procedure under general anesthesia. Gerald Kranis, M.D., was the anesthesiologist during the procedure. Respondent made a small vertical incision in the umbilicus and insufflated the abdomen with carbon dioxide gas. Respondent then entered the abdomen through a visiport with a 10-millimeter scope. He initially examined the upper abdomen. The patient’s liver and gall bladder appeared normal. Respondent next turned the laparoscope caudally. Inspection of the pelvic organs revealed numerous adhesions of the omentum and bowel to the anterior abdominal wall and to the uterus. Respondent took down the adhesions with sharp dissection with no bleeding. Respondent noted that there was adherence of the bowel to the anterior uterus. This was dissected away with sharp dissection. Inspection of the right adnexa showed a hemmoraghic cyst of the left ovary, and this was dissected by sharp dissection. In the process, the cyst ruptured extruding chocolate-appearing material. The cyst wall was grasped with an atraumatic grasper and teased out. Hemostasis was secure, and the cyst was retained to be sent to pathology. Inspection of the cul-de-sac revealed numerous adhesions of the bowel to the posterior uterus, and these were lysed with sharp dissection. At the end of the procedure, just before Respondent exited the abdomen, the patient’s blood pressure dropped. Inspection of the abdomen revealed no increased bleeding, but there was one area when viewed through the laparoscope that was suspicious of a hematoma. Respondent removed the laparoscope and placed a Foley catheter in the bladder. Respondent then performed a laparotomy, entering the abdomen through a Pfannenstiel incision. There were numerous adhesions of the bowel to the anterior abdominal wall, and Respondent lysed them with sharp dissection. Respondent then discovered a retroperitoneal hematoma. Respondent applied pressure on this area, and a vascular surgeon was summoned. Although the medical records do not specify that pressure was applied with a wet pad, the Department’s expert and Respondent’s expert interpret the description in the medical records to show that Respondent applied direct pressure with a wet pad. Upon his arrival, Manuel Torres-Salich, M.D., a vascular surgeon, assumed responsibility for managing the patient. He noted that the systolic pressure was 60 MMHG, and he extended the Pfannenstiel incision to a long midline vertical incision. Upon entering the abdominal cavity, he noticed a massive amount of blood throughout the abdominal cavity. However, he did not quantify the amount of blood he observed. Dr. Torres-Salich attempted the surgical repair of the patient’s vascular injuries. He discovered a large anterior laceration of the right proximal common iliac artery at the bifurcation of the aorta and a laceration of the anterior wall of the iliac vein. During the course of the surgical repairs, the patient experienced cardiac arrest, and CPR was administered while the vascular surgical repairs continued. As Dr. Torres-Salich continued to repair the vascular injuries, the patient experienced further cardiac complications. Cardiac massage and CPR were performed. The patient did not respond and expired. No evidence was offered as to the medical equipment available at Columbia Surgical Park Center. Specifically, no evidence was offered as to whether vascular clamps were available for use by Respondent, and, if available, whether these were the type of clamps appropriate for controlling a vascular injury of the iliac artery or iliac vein by a gynecologist. Further, no evidence was offered as to the types of medical personnel available at Columbia Surgical Park Center to assist Respondent other than anesthesia personnel. The record in this cause is clear, however, that a vascular surgeon was not in attendance at Columbia Surgical Park Center during patient A. J.’s procedure but was summoned on an emergency basis. The vascular surgeon arrived within about 20 to 25 minutes after the vascular emergency was discovered. The vascular lacerations that occurred to the iliac artery and iliac vein were lacerations to two of the largest blood vessels in the body. There is no evidence that any improper technique by Respondent during the laparoscopic procedure caused the lacerations of the iliac artery and iliac vein. The exact cause of these lacerations is not known. However, there are three possible causes: from insertion of the Voorhees needle, from insertion of the trocar, or from dissection of adhesions. A gynecologist who experiences a significant vascular injury, such as a laceration of an iliac artery, is trained to abandon the laparoscopic approach immediately, make an incision via laparotomy, and place direct pressure right on the area with a hand or pack. Respondent handled the laparoscopic complication appropriately by performing a laparotomy and applying direct pressure to the retroperitoneal hematoma. Respondent also handled the laparoscopic complication appropriately by calling for the emergency assistance of a vascular surgeon. General gynecologists are not trained to repair vascular injuries, and the immediate objective of a gynecologist once a vascular injury is identified is to do one of two things: apply direct pressure to the area of the bleed or try to clamp the vessel. Visualization of the specific vessel causing the bleed is required to properly use a clamp. Visualization of the specific blood vessels causing this patient’s retroperitoneal hematoma would require Respondent to perform a retroperitoneal dissection, which general gynecologists are not trained to perform. The standard of care in such a situation is for the gynecologist to summon a vascular surgeon. Further, if a gynecologist is not able to identify the exact point of injury, then direct pressure to the hematoma is sufficient and within the standard of care. There is no evidence that Respondent ever attended a gynecologic oncology fellowship where a general gynecologist would get additional training to be able to perform a retroperitoneal dissection. Respondent did not deviate from the standard of care by failing to perform a retroperitoneal dissection to visualize the specific blood vessels causing the hematoma. Respondent did not deviate from the prevailing standard of care by failing to apply pressure above the injury to stop the bleeding. Respondent’s application of pressure at the site of the hematoma was proper. Respondent did not fail to adequately prepare for and deal with a known complication of laparoscopy. He complied with the standard of care by stopping the laparoscopic approach, performing a laparotomy, applying pressure to the bleeding site, and immediately calling a vascular surgeon.
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 allegations contained in the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 28th day of March, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration 2727 Mahan Drive Building Three, Suite 3431 Post Office Box 14229 Tallahassee, Florida 32317-4229 Mark A. Dresnick, Esquire Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. SunTrust Plaza, Suite 701 201 Alhambra Circle Coral Gables, Florida 33134 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues in this case for determination are whether Respondent James C. Dozier, M.D., committed the violations of Chapter 458, Florida Statutes (2003), as alleged in an Administrative Complaint filed by the Department of Health on October 3, 2006; and, if so, what disciplinary action should be taken against his license to practice medicine in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, James C. Dozier, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 47971. Dr. Dozier’s mailing address of record at all times relevant to this matter is Indian River Memorial Hospital Department of Emergency Medicine, 1000 36th Street, Vero Beach, Florida 32960. Dr. Dozier is board-certified in Emergency Medicine. Dr. Dozier has previously been subject to license discipline in Agency for Health Care Administration Case Number 93-20295. Patient D.C. On September 3, 2003, Patient D.C. was 49 years of age and obese. He was living a largely sedentary lifestyle, having suffered a work-related spinal injury several years before 2003. D.C. did not work. He was taking methadone, a powerful narcotic painkiller used for long-term, chronic pain relief, daily. As a result of his spinal injury, D.C. spent most of his time at home and did not engage in significant physical activity. On September 3, 2003, D.C. experienced an episode of hard coughing, during which he produced brown sputum. At approximately 9:15 a.m., September 4, 2003, D.C. awoke with sharp, left-sided chest and shoulder pain, and shortness of breath. The pain in his chest was excruciating and he had difficulty breathing. Consequently, his wife, S.C., telephoned 911 and requested emergency assistance at approximately 9:19 a.m. Transport of Patient D.C. to the Hospital. Emergency medical services personnel (hereinafter referred to as “EMS Personnel”), arrived at D.C.’s house at approximately 9:25 a.m., September 4, 2003. What transpired beginning with the arrival of EMS Personnel and their delivery of D.C. to Indian River Memorial Hospital (hereinafter referred to as “Memorial Hospital”), was documented in an Indian River County EMS report, Incident # 014509 (hereinafter referred to as the EMS Report). A copy of the EMS Report was admitted as Petitioner’s Exhibit 3. As alleged in the Administrative Complaint, the EMS Report indicates the following: D.C.’s lung sounds were decreased on the left side with wheezes in several fields bilaterally and during transport to the hospital there was no change in his pain, although there was a decrease in the wheezing; At 9:27 a.m. D.C.’s pulse rate was 110, respiratory rate was 24 and oxygen saturation level was 92 percent by pulse oximetry; At 9:39 a.m. D.C.’s pulse rate was 116, respiratory rate was 24, and oxygen saturation level was 97 percent after the administration of oxygen by nasal cannula. A copy of the EMS Report was not provided to Memorial Hospital until after the events relevant to this case. While the EMS Report notes that EMS Personnel “[t]ransferred care to ER nurse with report,” the nature of the “report” was not proved during the hearing of this matter. Dr. Dozier was not made aware of the contents of the EMS Report or the “report” purportedly made by EMS Personnel to the emergency room nurse. Nor did he make any effort to inquire about D.C.’s condition during the time he was in the care of EMS Personnel. While the evidence presented at hearing proved that Dr. Dozier should have made an effort to inquire about D.C.’s condition during the time he was in the care of EMS Personnel, the charges in this case are limited to Dr. Dozier’s actions after D.C.’s arrival at Memorial Hospital; there is no allegation in the Administrative Complaint relating to any failure on the part of Dr. Dozier to determine what data EMS Personnel were aware of or ultimately reported. Most importantly, while there are allegations of fact concerning what EMS Personnel determined about D.C.’s condition, the Administrative Complaint does not inform Dr. Dozier of how those facts related to his care of D.C. What was in the EMS Report is, therefore, ultimately not relevant in deciding whether the allegations of the Administrative Complaint have been proved. Counsel for the Department has accurately reported parts of the EMS Report in paragraphs 23 through 32 of Petitioner’s Proposed Recommended Order and counsel for Dr. Dozier have accurately summarized some of the information contained in the EMS Report in their proposed finding of fact 8. Those proposed findings of fact, although accurate, have not been included in this Recommended Order because they relate to information which Dr. Dozier never had at the times relevant to this case. Dr. Dozier’s Treatment of Patient D.C. EMS personnel delivered D.C. at Memorial Hospital at approximately 9:54 a.m., September 4, 2003. It was documented in the Emergency Room (hereinafter referred to as the “ER”), nurse’s notes, that D.C., upon arrival, reported that he had suffered a severe coughing spell the night before, experienced increased shortness of breath, coughed up dark brown sputum, and had felt sharp left-side chest pain. It was also documented that D.C.’s oxygen saturation was 94 percent on supplemental oxygen; he was experiencing the highest level of left-sided chest pain, pain that increased with deep breaths; he was awake, alert, and oriented; his complexion was normal in color; his pulse rate was 99 beats per minute; and his respiratory rate was 22 breaths per minute. An ER nurse noted that D.C. had a history of spinal surgery and was taking methadone. Another ER nurse saw D.C. at approximately 10:00 a.m. The nurse noted in the record that D.C. was suffering sharp pain on inspiration, his oxygen saturation had increased to 97 percent on two liters of supplemental oxygen, and that he had decreased breath sounds on the left side of his chest. One of the nurses who saw D.C. ordered blood tests, including a complete blood count, cardiac markers, a differential, and a complete metabolic panel. The blood tests were subsequently cancelled. The only documentation in D.C.’s medical records at Memorial Hospital indicates that the tests were cancelled at 10:15 a.m. with a notation “Cancelled Requested by Nurse/MD PER DR DOZIER,” although Dr. Dozier did not first see D.C. until approximately 10:15 a.m. Dr. Dozier testified at final hearing that the tests had been cancelled at D.C.’s request. There are no medical notes to substantiate this testimony. Dr. Dozier documented his care of D.C. in an “Any Complaint Template” form with a time stamp of 10:17:33 a.m. Dr. Dozier noted in the Any Complaint Template that D.C. was suffering from sharp, left-sided chest pain of several hours duration with splinting (stiffening of the body to avoid pain caused by movement) and decreased breath sounds on the left side. Dr. Dozier also documented that D.C.’s past medical history included chronic pain that was being treated by methadone. Dr. Dozier ordered a chest X-ray and an EKG. He also started D.C. on Toradol, a non-steroidal, anti-inflammatory drug used for pain relief, and Levaquin, an antibiotic. The chest X- ray and EKG were documented in the Any Complaint Template. The EKG performed on D.C. was normal. His chest X-ray was interpreted by the radiologist as normal, except that he was exhibiting poor inspiratory effort. Dr. Dozier, under “differential diagnosis,” listed pleurisy (an inflammation of the lining of the chest wall and lungs marked by chest pain that increases on inspiration) first and pneumonia (an infection of the lungs marked by a severe cough, chest pain, and fever) second. A “differential diagnosis” was explained by Dr. Murray: Differential diagnosis is when you have a patient that comes into the emergency room and he has this constellation of signs and symptoms and risk factors. You try to put it together, you make a list, here’s all the possible things that could be wrong with this guy. So that’s your differential diagnosis. What are the possibilities here with what I have to look at. So you list our differential diagnosis. Transcript, page 39, lines 22-25, and page 40, Lines 1-4. Based upon the information which Dr. Dozier had concerning D.C., while pleurisy and pneumonia were reasonably included in his differential diagnosis, he should have also considered myocardial infarction, bronchitis, and, most significantly, pulmonary embolus. Of significance in this case, is Dr. Dozier’s failure to include pulmonary embolus in his differential diagnosis. Pulmonary embolus is a condition whereby the arteries in the lungs are blocked by one or more blood clots. A pulmonary embolism usually occurs when blood clots that have formed in the veins of a person’s extremities dislodge and are transported by the blood stream to the lungs where they become trapped by smaller arteries. The formation of blood clots in the extremities is called deep vein thrombosis (hereinafter referred to as the “DVT”). When blood clots become lodged in the lungs, the lungs can be damaged or, if blood flow becomes too constricted, the person can die. Pulmonary embolisms are encountered in emergency rooms with some frequency. In determining whether a person is suffering from pulmonary embolus, the common risk factors must be considered. Those risk factors include a history of previous pulmonary embolus or DVT; immobilization (the person is confined to bed, sedentary, or has recently taken a long trip); smoking; obesity; hypercoagulablity (increased tendency of the blood to clot); and cancer. The most common signs of pulmonary embolus are chest pain, usually of sudden onset and which becomes worse with deep breathing or coughing; shortness of breath, again of a sudden nature; sweating; nausea; rapid breathing or tachypnea; increased heart rate or tachycardia; low oxygen saturation; and hemotysis or coughing up blood. Making it difficult to diagnose, a patient with a pulmonary embolism may present with various combinations of symptoms, and the symptoms are often similar to those of other ailments, such as heart attack, bronchitis, pleurisy, pneumothorax, acid reflux, dissecting thoracic anerurysm, and pneumonia. Tests which can assist a physician in the either confirming or ruling out a pulmonary embolism, include ventilation/perfusion scanning (hereinafter referred to as “V/Q Scanning”), d-dimer testing, spiral computerized axial tomography, pulmonary angiography, and Doppler ultrasound. While not all of these tests were available to Dr. Dozier, V/Q Scanning was. Pulmonary embolus should have been included in Dr. Dozier’s differential diagnosis of D.C. because D.C. arrived at the ER with a chief complaint of chest pain and, as explained by Dr. Murray because of the following: Now, what would even make [pulmonary embolus] more likely, and perhaps having to pursue a little bit more, is the type of pain that he had, which is important to tell the difference between a lot of those conditions. He had pleuritic pain. That’s the classic type of chest pain that somebody with a pulmonary embolus has as classically described as pleuritic sharp chest pain. That’s what this patient had. Then what was the onset? Was this gradual onset or sudden? P[ulmonary] E[mbolism]s are sudden onset. As far as I can tell, when it says in timing, it says symptoms for, now I can’t read that, how many that is, but he had circled hours. So I can just assume that he told Dr. Dozier that he was having these symptoms just for however many hours that stands for. So I was worried about the chest pain, the nature of the chest pain, the short duration of it, that I think it says brownish – or I’m not even – I would cough brownish sputum. I think that’s what it says, but I couldn’t say for sure under history of present illness, which would make me worry about that. Transcript, page 85, lines 3-23. D.C.’s history of acute onset shortness of breath and severe left-side pleuritic chest pain, his possible hemoptysis the night before his arrival at Memorial Hospital, and his elevated pulse and respiratory rates, all facts that were documented in the medical records for D.C. at Memorial Hospital, should have caused Dr. Dozier to include pulmonary embolus in his differential diagnosis. As a result of the fact that he did not consider pulmonary embolus as a possible ailment, Dr. Dozier failed to order tests which could have helped him to rule out pulmonary embolus or led him to conclude that D.C. was suffering from the ailment. In particular, he failed to order a V/Q scan. Ultimately, Dr. Dozier released D.C., listing as his final diagnoses pleurisy and bronchitis (inflammation of the bronchial tubes marked by painful cough and fever). Dr. Dozier prescribed Vioxx, a non-steroidal anti-inflammatory drug, Levaquin, and Flexeril (a central nervous system depressant, commonly referred to as a “muscle relaxer”). Cancellation of the Blood Tests. As noted in Findings of Fact 19, blood tests ordered for D.C. were ultimately cancelled. According to Dr. Dozier, they were cancelled because D.C. refused the tests, a suggestion that was not documented by Dr. Dozier in D.C.’s medical records, despite the seriousness of a patient refusing tests which a physician prescribes. Given the significance of the consequences of such a refusal, Dr. Dozier’s testimony on this point is questionable and rejected as not convincing. Other facts also raise concerns about the credibility of Dr. Dozier’s testimony concerning the cancellation of the blood tests. For example, S.C. saw D.C. approximately an hour after his arrival at the hospital and found him quiet, pale, and looking very ill. At no time did D.C. or Dr. Dozier, whom she had spoken with, inform S.C. that D.C. had refused blood tests. It is also noted that D.C. did not refuse other tests, including the chest X-ray and EKG ordered by Dr. Dozier. Ultimately, Dr. Dozier’s explanation concerning the cancellation of the blood tests was not convincing, based upon findings made in this Recommended Order and because of the troublesome aspects of his testimony as explained in paragraph 51 of Petitioner’s Proposed Recommended Order, which is incorporated by reference. Despite this conclusion, ultimately, it was the Department’s burden to prove why the blood tests were cancelled. This the Department simply did not do. Ultimately the evidence simply proved that the tests were ultimately cancelled. Regardless of why the blood tests were cancelled, Dr. Dozier violated the standard of care, as found, infra. Instructions on Discharge. On discharge, D.C. was given the following written instructions on a pre-printed form: The doctor thinks your symptoms may be due to: PLEURISY. Keep this in mind: DIAGNOSIS WITH 100% CERTAINTY IS NOT POSSIBLE in the Emergency Department. Therefore, if you find you are not getting better, another diagnosis is possible, and you must see your doctor or return here. After you leave, you must properly care for your problem and observe its progress. If you do not improve as expected, or are worse, do one of the following. Immediately: contact your doctor or follow up doctor or call here [the ER]. Contact your doctor, call, or return here if you experience any of the following: A) high fever or chills B) difficulty breathing C) difficulty; swallowing or drooling D) pain or tightness in chest or neck E) thick green or bloody sputum F) fast pulse (more than 100 a minute at rest) G) vomiting. Your symptoms should improve within 4-6 days and should not worsen. You should be able to breathe comfortably when sitting or lying down, and should not be struggling to breathe. You should be able to eat, drink, and swallow without pain or drooling. Rest, drink plenty of fluids, and eat regular well-balanced meals. Use Acteminophen (Tylenol, etc.) for pain or fever, and take any prescribed medications. A cool-mist vaporizer may help decrease cough and discomfort. DO NOT use a hot mist vaporizer of hot steam. DO NOT smoke during your illness; smoking will delay your recovery. The forgoing instructions were consistent with Dr. Dozier’s diagnosis of pleurisy or bronchitis. Having failed to consider pulmonary embolus, the instructions were inadequate in failing to address this possible condition. The Standard of Care. The Department's expert, John V. Murray, M.D., credibly opined that Dr. Dozier failed to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure in violation of Section 458.331(1)(t), Florida Statutes (hereinafter referred to as the "Standard of Care"), in his treatment of D.C. In particular, it was Dr. Murray’s opinion that Dr. Dozier violated the Standard of Care by failing to recognize the possibility that D.C. was experiencing a pulmonary embolism and, as a consequence, by failing to include pulmonary embolus in his differential diagnosis; and by failing to order diagnostic tests, in particular V/Q Scanning, which may have either ruled out or confirmed the existence of a pulmonary embolism. Dr. Murray’s opinions are credited and accepted. The opinions to the contrary offered by Dr. Dozier and his expert witness are rejected as not convincing and as not addressing the issues precisely enough. Too much was made of facts which were not available to Dr. Dozier at the time he made his differential diagnosis and the consequences thereof, unlike Dr. Murray, who specifically testified, when asked whether he attempted “to put yourself in Dr. Dozier’s shoes on the day these events occurred,” as follows: A. Yes, sir. I think that’s necessary. If you’re going to make a finding that was the standard of care, I think the standard of care relates to what would the prudent physician in the same circumstances on the same day do. In order to do that, you put yourself in those shoes. Say if I was there what would I do and what would be the standard of care for that, the minimum. Transcript, page 33, lines 22-25, and page 34, lines 1-3. Dr. Murray went on to explain that, although he had learned from the documents presented to him, information that Dr. Dozier did not have available while caring for D.C., he was able to limit his opinions appropriately to the time of the actual events and the information which Dr. Dozier was presented with. The opinions offered on behalf of Dr. Dozier were not so precisely limited. Medical Records. Dr. Dozier failed to document in his medical records for D.C. whether D.C. was a smoker or had recently taken any long trips, both facts which are relevant bits of information when considering pulmonary embolus. Dr. Dozier’s medical records were, therefore, inadequate in this regard. Dr. Dozier also failed to give adequate follow-up instructions for pulmonary embolus upon discharge. Dr. Dozier’s actions, however, were the result, not of his failure to include pulmonary embolus in his differential diagnosis, but in the failure to accurately diagnosis D.C.’s condition, a failure for which Dr. Dozier has not been charged. I. D.C.’s Demise. On September 6, 2003, D.C. died in his sleep. A postmortem autopsy of D.C. revealed that he died of “massive pulmonary thromboembole due to phlebothromboses of lower extremities.” It was found that D.C. had an abdominal malignancy, a significant contributing factor in the death of D.C. What role, if any, that Dr. Dozier’s failures in his treatment of D.C. contributed to D.C.’s ultimate demise was not proved.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that James C. Dozier, M.D., has violated Section 458.331(1)(m) and (t), Florida Statutes, as described in this Recommended Order; issuing a reprimand; imposing a fine of $10,000.00; requiring that he complete the Florida Medical Association’s “quality Medical Record Keeping for health Care Professionals” course or a Board-approved equivalent; and requiring that he complete five hours of continuing medical education in diagnosis and treatment of pulmonary embolus. DONE AND ENTERED this 20th day of September, 2007, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of September, 2007. COPIES FURNISHED: Don Freeman, Esquire Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3250 Barry A. Postman, Esquire Lee Cohen, Esquire Cole, Scott & Kissane, P.A. 1645 Palm Beach Lakes Boulevard Second Floor West Palm Beach, Florida 33401 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
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 Dr. Cambo is licensed by the Board of Medicine, holding license number 48428, and was licensed at all times pertaining to the events alleged in the Administrative Complaint. L. M., a 67 year old male, arrived at the emergency room of John F. Kennedy Memorial Hospital in Atlantis, Florida, at 12:08 p.m., on April 15, 1987. L. M. had been a resident at the Atlantis Nursing Home. L. M. spoke Finnish; he did not speak English. He had had an amputation of a portion of his right leg two weeks earlier due to gangrene caused by peripheral vascular disease. The staples from this amputation were still visible. He had had a stroke, had irregularities in a prior E.K.G. and generally was in poor health. His current medications included ecotrin, motrin, vasotic, lopressor, halcion and catapress. He had indicated that he had chest pain to the nursing home staff and to the Fire-Rescue technicians by signing. When he arrived at the emergency room L. M. was described as cyanotic, diaphoretic and hypotensive. His breathing was labored. He was examined by the emergency room physician, Randall Wolff. L. M.'s chest pain, labored breathing and cyanotic appearance were consistent with cardiogenic shock. Dr. Wolff ordered certain diagnostic tests which included a complete blood count, a chest x-ray, and arterial blood gases. An E.K.G. was performed at approximately 3:00 p.m. that afternoon. L. M.'s urine color that afternoon was indicative of infection. Test results showed an elevated white blood count, and immature white blood cell forms. These are consistent with an active infection from the recent amputation or a myocardial infarction. Dr. Wolff thought the patient should have been admitted to J.F.K. because of his chest pain and abnormal vital signs. Dr. Cambo was contacted by the emergency room staff because Dr. Cambo was on call for the health maintenance organization which provided L. M.'s medical care. Dr. Cambo came to the hospital at about 2:40 p.m. and saw L. M. and other HMO patients. No treatment for L. M., other than oxygen, had been ordered by Dr. Wolff. Apparently, Dr. Wolff did not regard L. M.'s condition as serious. Dr. Cambo conducted a physical examination of L. M., who by that time denied having chest pain by signing. The examination revealed that the right stump had no femoral pulse, while the left leg had 2+ femoral pulse. His blood pressure was on the low side of the normal range. Dr. Cambo also reviewed L. M.'s test results, including the 3:00 p.m. E.K.G. tracing. Dr. Cambo then telephoned Dr. Jerome Vincente, the primary care physician who had managed the care of patient L. M. while L. M. was being served by the International Medical Center No. 90 in West Palm Beach. During that telephone call Dr. Cambo and Dr. Vincente compared the 3:00 p.m. E.K.G. tracing with a prior E.K.G. tracing from L. M.'s records at International Medical Center. The prior E.K.G. tracing was similar to that taken at 3:00 p.m. Dr. Cambo's reading of the 3:00 p.m. tracing led him to diagnose inferior wall ischemia and marked T anterior wall ischemia. Taken in isolation, the 3:00 p.m. tracing would indicate that L. M. might be having a heart attack. After the comparison Dr. Cambo made of the prior tracing, Dr. Cambo concluded that L. M.'s current cardiac condition was not abnormal for him, and decided to transfer L. M. to Humana Hospital for the purpose of achieving continuity of treatment, i.e., so that he would be seen at Humana by his regular physicians. Dr. Cambo believed L. M. had an infection resulting from the recent amputation and had circulatory problems which had resulted in gangrene that had caused the amputation. Dr. Cambo returned to J.F.K. Hospital at 3:30 p.m. to see HMO patients, including L. M. who had not yet been transferred to Humana Hospital. Dr. Cambo again examined L. M. and after reviewing the progress notes of L. M. maintained by the J.F.K. Hospital nursing staff, he determined that L. M.'s condition had not changed since 3:00 p.m. Dr. Cambo left J.F.K. Hospital between 5:30 p.m. and 6:00 p.m. with the instruction that L. M. be transferred to Humana. Due to the delay encountered in obtaining transportation, Dr. Cambo ordered that the patient continue to receive oxygen and that he receive I.V. fluids. Between 6:30 p.m. and 7:30 p.m. Dr. Cambo contacted the nursing staff at the J.F.K. Hospital emergency room on two occasions. Each time he was told that L. M.'s condition remained the same and had not altered since his arrival at the emergency room shortly after noon. The Atlantis Ambulance Service arrived at J.F.K. Hospital at about 7:45 p.m. to transport L. M. to Humana Hospital. At about 11:00 p.m. on April 15, 1987, patient L. M. died from an anterior wall myocardial infarction at Humana Hospital.
Recommendation It is RECOMMENDED that the charges contained in Count I of the Administrative Complaint be dismissed. Count II of the Administrative Complaint was dismissed by the Department at the final hearing and requires no further action by the hearing officer or the Board of Medicine. DONE and ENTERED this 3rd day of April, 1989, in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY 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 3rd day of April, 1989. APPENDIX Rulings on the proposed findings of fact. Findings proposed by Department of Professional Regulation. Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 3. Covered in finding of fact 2 and 3. Covered in finding of fact 2. Rejected as unnecessary. Covered in finding of fact 3. Covered in finding of fact 3. Covered in finding of fact 2. To the extent appropriate covered in finding of fact 3 and 4. Covered in finding of fact 3. Covered in finding of fact 3. Rejected because the programming of the data scope to produce the quoted printout was not proven to be accurate. What is most important is the judgment of the physicians who examined the patient and were in a much better position to evaluate the significance of the results, not only of the E.K.G., but of all testing. Covered in finding of fact 4. The proposed finding that L. M. communicated non-verbally due to aphasia is rejected because it is equally likely that he could not communicate because English was not his primary language. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected because the testimony of Dr. Cambo and Dr. Vincente indicates that the E.K.G. was not clearly indicative of myocardial infarction in this patient. Covered in finding of fact 4. Rejected as unnecessary and because there is no way to know whether the patient's blood pressure was low due to cardiogenic shock or the medication he was taking. Rejected is inconsistent with the Hearing Officer's view of the evidence. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected as unnecessary and irrelevant. There is no indication that the patient suffered from any problem because of the absence of written instructions for care to be given during the transfer. Rejected as inconsistent with the Hearing Officer's view of the evidence. Covered in finding of fact 5. Rejected because there was no argument between Dr. Wolff and Dr. Cambo about admitting the patient to J.F.K. The nursing notes, from which this inference is derived, are unreliable. Dr. Wolff did not testify to any such argument. Rejected as irrelevant. Rejected as unnecessary. Rejected as unnecessary. Rejected, the patient's breathing was not labored at 6:30 p.m. To the extent the nurses notes might indicate otherwise, they are rejected as unreliable. Rejected because the second page of the nurses notes is an after-the-fact creation. Rejected because the second page of the nurses notes is an after-the-fact creation. Rejected because the nurses notes have been found to be unreliable. Covered to the extent necessary in finding of fact 9. Covered to the extent necessary in finding of fact 9. Rejected as unnecessary. Rejected as unnecessary. Rejected as inconsistent with the Hearing Officer's view of the evidence. Rejected as inconsistent with the Hearing Officer's view of the evidence. Findings proposed by Respondent The findings proposed by the Respondent are not submitted in numbered paragraphs. The burden of the proposed findings of Dr. Cambo have been accepted. COPIES FURNISHED: LEE SIMMS, ESQUIRE DEPARTMENT OF PROFESSIONAL REGULATION 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750 ROBERT H. SPRINGER, ESQUIRE 3003 SOUTH CONGRESS AVENUE SUITE 1A PALM SPRINGS, FLORIDA 33461 DOROTHY FAIRCLOTH EXECUTIVE DIRECTOR FLORIDA BOARD OF MEDICAL EXAMINERS 130 NORTH MONROE STREET TALLAHASSEE, FLORIDA 32399-0750
The Issue The issues in this case are whether Respondent violated section 458.331(1)(t), Florida Statutes (2008),1/ and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. Dr. Puig was at all times material to the allegations in the Administrative Complaint a licensed physician in the State of Florida, having been issued license No. 82847. Dr. Puig holds a certificate from the American Board of Anesthesiology. In the early morning of January 2, 2009, T.M. presented to the Central Florida Surgery Center in Lakeland, Florida, for outpatient surgery to be performed by Shreekant Tripathi, M.D. The specific procedures to be performed were bilateral lower eyelid blepharoplasty, mini-face lift, and suspension of the mid-face area with the Endotine Midface implant device. She was accompanied by her husband, R.R. T.M. has been licensed as a physician in Florida for 28 years and has worked as the head of the Tampa General Hospital Adult Emergency Department and as that hospital's chief of staff. T.M. has a prior history of a deep vein thrombosis (DVT), which was treated medically. She experienced a DVT in her leg sitting in an airplane for an extended period of time while traveling from Florida to the Midwest. DVT is a medical condition that occurs when a thrombus (blood clot) forms in one of the large veins, leading to either partial or complete blockage of the vein. After completing the financial paperwork and other forms at the front desk of Central Florida Surgery Center, T.M. was taken to the pre-operative holding area at approximately 7:00 a.m. Once in the pre-operative holding area, the nurse went over the contents of T.M.'s procedures and reviewed T.M.'s medical history and medications taken. The nurse administered medications other than sedation and took T.M.'s vital signs, including her blood pressure. In order to take T.M.'s blood pressure, the nurse in the pre-operative holding area placed a blood pressure cuff on T.M.'s right upper arm. The blood pressure cuff would not have given a reading if it was placed too tightly, and T.M. would have complained of pain. At the time that the blood pressure cuff was placed, T.M. was awake and alert and did not express any discomfort. The nurse was able to get a reading from the blood pressure cuff. While T.M. was in the pre-operative holding area and after the vital signs were taken, T.M.'s temperature was 97.4 degrees. T.M. met with Dr. Tripathi, who went over her surgery with her. Dr. Tripathi marked the areas for her facial cosmetic procedures. Dr. Puig served on the surgical team as anesthesiologist. He conducted a pre-anesthesia evaluation of T.M. Dr. Puig examined T.M. and reviewed the medications that she was taking. He also reviewed T.M.'s medical history, including her history of DVT. As part of his plan for anesthesia, Dr. Puig included the use of sequential compression devices on T.M.'s lower extremities. While in the pre-operative holding area, T.M. was given Versed as a pre-medication for the surgery. T.M. was taken to the operating room, accompanied by Dr. Puig, who remained with T.M. until she was handed to the post-anesthesia care unit (PACU) nurse. T.M. entered the operating room at 8:19 a.m. The blood pressure cuff that was placed by the pre-operative nurse was left in place on the upper right arm. The blood pressure cuff was disconnected from the monitoring device in the pre-operative holding area and accompanied T.M. into the operating room, where it was connected to another monitoring device. After T.M. was taken to the operating room, she moved onto the operating table on her own with some assistance. Monitoring equipment was then connected to T.M. The monitoring equipment included a pulse oximeter on the left hand, sequential compression devices on the lower extremities, and the blood pressure monitoring device. Dr. Puig did not use any device to monitor T.M.'s temperature during the surgery. An IV had been placed in the pre-operative area on T.M.'s left wrist and was running in the operating room. T.M. was positioned flat on her back on the operating table with her shoulders on the operating table using a mattress, a pillow, foam pads, and sheets. On the table, under T.M., was a two-to-three-inch thick mattress. On top of the mattress, under T.M., was a bottom sheet that ran longitudinally the length of the table. On top of the bottom sheet, perpendicular with, or at a 90-degree angle to the table, was a folded sheet from 18-to-30 inches wide. This crossways sheet is called a draw sheet and was under T.M. with the top edge at the armpit and the lower end in line with the waist or buttocks. The draw sheet was pulled up between T.M.'s arm and torso for later tucking. A foam pad, egg-crate device was placed on the right arm between the arm and the table and T.M. The device is not large enough to completely cover the arm. The bottom sheet was tucked around the arm between the egg-crate device and T.M.'s torso. The draw sheet was then tucked around the outside of the arm and under the mattress with a portion left protruding, which could be pulled on later to begin the process of removing the sheets. The purpose of the sheets was to keep T.M.'s arm from falling off the table during surgery. The sheets were supposed to be snug, but not so tight that one could not insert two fingers between the sheets and T.M.'s arm. In addition to the sheets that covered T.M., a Bair Hugger was used. A Bair Hugger is a warming device that uses forced warm air to keep a patient warm during surgery. The blood pressure cuff was under a portion of the egg-crate device, the bottom sheet, the draw sheet, and the Bair Hugger. The top edge of the blood pressure cuff was just under the armpit and the bottom edge was approximately three-to-four inches above the elbow joint. The blood pressure cuff had an inflatable rubber bladder and normally would have an attached inlet tube about six-to-eight inches long that would extend down T.M.'s arm toward her wrist. In order to eliminate sources of infection, a sterile field was created by using sterile towels and sterile drapes. The sterile drape covered T.M. after the other sheets and blankets were in place. The sterile towels were placed around T.M.'s head. At 8:41 a.m., the surgery began. Prior to the commencement of surgery and while in the operating room, Dr. Puig monitored T.M.'s blood pressure using the monitoring device in the operating room and the blood pressure cuff that was placed on T.M.'s right arm. Dr. Puig had blood pressure readings until 8:58 a.m., when Dr. Puig was unable to get blood pressure readings. Dr. Puig asked Dr. Tripathi to step aside and allow him to check the blood pressure cuff. Dr. Puig was on the right side of T.M. and moved to the left side of T.M. He asked the circulating nurse to hold the sterile drape so that he could go under the drape to check the blood pressure cuff. Dr. Puig went under the drape and felt the blood pressure cuff. The blood pressure cuff was deflated. He disconnected the tube from the blood pressure cuff and called for a new blood pressure cuff. He placed the new blood pressure cuff on T.M.'s left arm and connected the new blood pressure cuff to the blood pressure monitoring device. Dr. Puig was able to get accurate blood pressure readings from the new blood pressure cuff and the monitoring device that had been attached to the blood pressure cuff on T.M.'s right arm. Dr. Puig left the deflated blood pressure cuff on T.M.'s right arm during the surgery. After a blood pressure cuff was placed on T.M.'s left arm, Dr. Tripathi continued with the surgery. The surgery ended at 1:48 p.m., at which time the circulating nurse began to remove the sterile drape and sheets from T.M. When the nurse removed the deflated blood pressure cuff on T.M.'s right arm, she noticed that the arm below the blood pressure cuff was mottled, blue, red, dark blue and dark red. There were blisters on T.M.'s right arm where the blood pressure cuff had been. T.M.'s right arm was swollen. The condition of T.M.'s right arm was brought to the attention of Dr. Puig. Dr. Puig examined and evaluated T.M.'s condition. At 2:00 p.m., T.M. was transferred to the PACU. T.M. was alert. Her temperature was 98 degrees. Her husband, R.R., was at bedside when T.M. was taken to PACU and stayed at her bedside until T.M. was discharged. T.M. was experiencing extreme pain in her right arm and felt a tender hard spot on her right bicep. The post- operative nurse noted the condition of T.M's right arm as red and swollen from the biceps to the tips of T.M.'s fingers with blisters on the upper part of the extremity. Dr. Puig noted that T.M. had decreased sensation in her right finger tips and some decrease in motor activity and that T.M's radial and ulnar pulses were intact. He ordered that the right arm be elevated with the use of pillows. At 2:15 p.m., Dr. Puig was at T.M.'s bedside, monitoring T.M.'s condition. Dr. Tripathi was aware of T.M.'s condition and also appeared at her bedside to monitor her condition. Dr. Puig consulted with Dr. Tripathi concerning T.M.'s condition. At 2:30 p.m., T.M. was still being monitored by the PACU nurse. T.M. was moving her arm, fingers, and wrist. At 2:55 p.m., T.M. told the nurse that she was unable to feel her pulse. Two nurses took T.M.'s pulse and verified that T.M. did have a pulse. Dr. Puig and Dr. Tripathi had gone back to the operating room for a procedure on another patient. At 2:55 p.m., a nurse notified Dr. Puig of T.M.'s complaint of feeling no pulse. At 3:08 p.m., T.M. complained of a decrease in sensation from her elbow to her fingers. T.M. suggested to the PACU nurse that measurements should be taken of the circumference of her arms to determine how much swelling had occurred. At 3:10 p.m., the nurse marked the area on the arms to be measured and took measurements of the bicep and forearm in each arm. The right bicep measured 30 centimeters, and the right forearm measured 28 centimeters. The left bicep measured 29 centimeters, and the forearm measured centimeters. T.M. and her husband became concerned about the condition of T.M.'s right arm. The right arm was still elevated by pillows, and T.M. continued to exercise the arm. At 3:14 p.m., T.M. stated that she could feel her right radial pulse. T.M.'s right bicep remained red and swollen. T.M. denied the need for pain medication. At 3:20 p.m., T.M. continued to exercise the right arm, hand, wrist, and fingers. T.M. complained of pain in the right bicep and a knot in the right bicep. At 3:40 p.m., T.M. continued to complain of pain in the right bicep. T.M. was squeezing her right hand and moving her right arm. T.M. was experiencing a prickly sensation to her forearm and hand from the elbow down. The nurse determined that there was a right radial pulse. Dr. Puig was notified of T.M.'s condition. The nurse gave T.M. a bolus of 25 micrograms of Fentanyl; however, the pain medication did not give T.M. any relief. Dr. Puig had given an order for 25 micrograms of Fentanyl to be administered every five-to-15 minutes up to a maximum of 100 micrograms. Fentanyl is a short-acting pain medication. The opiate is more potent that morphine. The effects of Fentanyl will wear off about 20 to 30 minutes after administration. At 3:50 p.m., the nurse administered another bolus of micrograms of Fentanyl to T.M. At 3:54 p.m., T.M was fully flexing and extending her right arm and stated that the second dose of Fentanyl had given her some relief to the pain. At 4:00 p.m., the nurse measured the right arm again. The right bicep was 30 centimeters, and the right forearm was 26.5 centimeters. At 4:07 p.m., T.M. requested more pain medication, and the nurse administered another bolus of 25 micrograms of Fentanyl. T.M. received fair relief from the pain as a result of the pain medication. At 4:25 p.m., T.M. stated that she could feel sensation to her right hand, but was unable to distinguish between sharp and dull pain. She denied the need for further pain medication. At 4:41 p.m., T.M. continued to have pain in her right bicep. She was experiencing numbness and tingling in her right hand and forearm. From the right elbow to her hand, her arm was red, mottled, and petechiae. The right bicep was warm and swollen with thin blisters. The bicep was firm and painful. T.M. requested and was given another 25 micrograms of Fentanyl. At 4:50 p.m., the pain medication had produced only minimal relief from the pain. At 4:53 p.m., T.M. told the PACU nurse that her pain and swelling was not getting any better and that she wanted to be transferred to Tampa General Hospital after she saw Dr. Puig and Dr. Tripathi, who were still in surgery. Dr. Puig and Dr. Tripathi were notified in the operating room. The nurse continued to monitor T.M. T.M. thought that she may have compartment syndrome. Compartment syndrome is a condition that results from increased pressure in the compartment (the muscle surrounded by the fascia), which can lead to lack of perfusion, nerve damage, and eventually to the loss of function of the extremity. It is characterized by pain out of proportion to the nature of the observable injury that will not be alleviated by the administration of narcotic pain medication, swelling, pallor, paraesthesia, lack of pulse, and eventually lack of temperature control. Dr. Puig consulted with Dr. Tripathi throughout the time that T.M. was in PACU concerning T.M.'s right arm. Dr. Tripathi has had training in hand surgery, and, as a surgeon, is familiar with compartment syndrome. Compartment syndrome in the upper arm is a rare event. Neither Dr. Puig, nor Dr. Tripathi, felt that the swelling and pain in T.M.'s arm was due to compartment syndrome. Because of her history with DVT and the similarity of some of the conditions associated with both compartment syndrome and DVT, it was felt that T.M. could have DVT in her upper arm. At 5:00 p.m., Dr. Puig and Dr. Tripathi came to T.M.'s bedside. T.M. was able to flex and extend the right fingers, to perform abduction and adduction of the right fingers, and to extend and flex the right wrist. At 5:30 p.m., Dr. Puig was again at T.M.'s bedside. Ice was applied to the elevated bicep. The circumference of the right bicep was measured and recorded at 33 centimeters. T.M. requested that the PACU nurse call Dr. Kelly O'Keefe at Tampa General Hospital. T.M. spoke to Dr. O'Keefe and advised that she was coming to the emergency room at Tampa General Hospital. Dr. Tripathi and Dr. Puig were aware that T.M. was going to Tampa General Hospital. Dr. Tripathi suggested that an ultrasound be done. At 6:00 p.m., T.M. requested that she been given another dose of Fentanyl to help with the pain while she was traveling to Tampa General Hospital, which was about an hour away from the Central Florida Surgery Center. She was discharged to be transported to Tampa General Hospital by her husband via automobile. At the time of discharge, there was continued swelling and redness of T.M.'s right arm. She was experiencing pain in her right bicep. Her right arm from her elbow to fingers was eccymotic. T.M. presented at the Tampa General Hospital Emergency Department approximately an hour after her discharge from the Central Florida Surgery Center. When she arrived at Tampa General Hospital, her right arm was red and swollen from her elbow to her fingertips. Her motor/sensory function was intact with positive radial and ulnar pulse by Doppler. She was triaged as a semi-urgent patient, Acuity 4. Dr. Kelly O'Keefe examined T.M. and found the following: Extremity/Pain-injury to the RUE, pt underwent surgery today, possible issue with bp cuff right arm during surgery, pt with redness and swelling from elbow joint to finger tips, m/s intact, positive radial pulse and dopplarble [sic] ulnar. Had blepharoplasty and chin tuck done. Pain in left arm is 10/10. Arm is swollen. Forearm with petchia [sic] diffusely, NO SOB, no chest pain. No fever. NO other current complaints. Cuff on about an hour. Prior DVT, off Coumadin now, in leg. NO PE in past. Weakness of hand/wrist associated with pain. Primary symptom. Dr. O'Keefe's differential diagnosis was the following: Evaluate for DVT in upper extremity ?arterial occlusion secondary to cuff without ongoing evidence of arterial blockage, but with likely ischemic neuropathy. Will consult neurology. Doppler scans ordered. Dr. O'Keefe ordered, among other things, a Doppler scan, a complete blood count, a cretatine phosphokinase blood (CPK) study, elevation of the arm, and Fentanyl for pain. He requested consultations with a neurologist and a vascular surgeon. At 7:49 p.m., T.M. was given 100 micrograms of Fentanyl. An ultrasound was performed. After T.M. returned from having an ultrasound done, the nurse noted that T.M. was complaining of pain in her right arm as ten, on a scale of one to ten, with ten being the most painful. There was edema to the right bicep area with stripes of vertical ecchymosis around the entire bicep. The bicep was tender to palpitation and slightly hard to the touch. Petechiae and ecchymosis were noted from elbow to fingertips. The area from the elbow to the fingertips was also edematous, tender to palpitation. Radial and ulnar pulses were detected using a bedside Doppler. There was positive motor/sensory function in the right arm, but slightly weak. T.M.'s right arm was elevated and ice packs were applied. At 9:36 p.m., the neurologist was at bedside with T.M. At 9:42 p.m., Dr. O'Keefe noted that T.M.'s pain and swelling were worsening, which suggested the development of compartment syndrome. At 10:07 p.m., T.M. was given another 100 micrograms of Fentanyl. At 10:45 p.m., T.M. was complaining of pain in her right arm as a ten, on a scale of one to ten. T.M. stated that the Fentanyl was not lasting very long. Dr. O'Keefe was notified, and he ordered one milligram of Dilaudid. At 9:56 p.m., Dr. O'Keefe noted that the Doppler study indicated that there was "[n]o evidence of arterial thrombosis or high grade stenosis," thus, ruling out DVT. The vascular surgeon, Dr. Brad Johnson, saw T.M. at 11:23 p.m. Dr. Johnson was concerned about compartment syndrome. He performed a right upper arm fasciotomy. His discharge diagnosis was right upper-extremity compartment syndrome. As part of his board certification, Dr. Puig is required to comply with the American Society of Anesthesiologists guidelines for anesthesia care. The American Society of Anesthesiologists has developed Standards for Basic Anesthetic Monitoring. The preamble provides: These standards apply to all anesthesia care although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible anesthesiologist. They are intended to encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. They apply to all general anesthetics, regional anesthetics and monitored anesthesia care. This set of standards addresses only the issue of basic anesthetic monitoring, which is one component of anesthesia care. In certain rare or unusual circumstances, 1) some of these methods of monitoring may be clinically impractical, and 2) appropriate use of the described monitoring methods may fail to detect untoward clinical developments. Brief interruptions of continual monitoring may be unavoidable. These standards are not intended for application to the care of the obstetrical patient in labor or in the conduct of pain management. Standard II of the Standards for Basic Anesthetic Monitoring provides: During all anesthetics, the patient's oxygenation, ventilation, circulation and temperature shall be continually evaluated. * * * BODY TEMPERATURE OBJECTIVE To aid in the maintenance of appropriate body temperature during all anesthetics. METHODS Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated or suspected. Loss of large amounts of blood or exposure of body surface was not contemplated for T.M.'s cosmetic surgery. Since T.M. was an adult, was almost completely covered by sheets, and was under a Bair Hugger which supplied forced warm air, Dr. Puig did not feel that T.M. would experience clinically significant changes in body temperature. Dr. Puig controlled the amount of fluids used during the surgery and anticipated the blood loss based on the incisions that would be used by Dr. Tripathi. Dr. Sanchez-Salazar testified as an expert for the Department. Dr. Sanchez-Salazar is a board-certified anesthesiologist. He has been licensed to practice medicine in Florida since 1963. He has been working as a solo practitioner in a stand-alone outpatient surgical facility since 1993. Dr. Sanchez-Salazar testified at the final hearing that he interpreted the temperature-monitoring standards of the American Society of Anesthesiologists to mean that the body temperature of a patient had to be monitored at all times during surgery. He also testified at the final hearing that he does not monitor the patient's temperature during surgeries that last a short period of time. During his deposition taken on August 17, 2010, he testified that he did not monitor patients' temperatures on procedures that lasted an hour or less. He also opined that the monitoring standards of the American Society of Anesthesiologists required that temperatures be monitored when the surgery lasted more than an hour. It is clear that Dr. Sanchez-Salazar did not consider that the monitoring of temperatures should be determined based on whether a clinically significant change in temperature would be intended, anticipated, or suspected. Dr. Sanchez-Salazar's testimony is not credible. Dr. Nikolaus Gravenstein testified as an expert for Dr. Puig. Dr. Gravenstein has been licensed to practice in Florida since 1983. He became board-certified in anesthesiology in 1984 and has continued to voluntarily recertify. He is a professor of anesthesiology at the University of Florida. Dr. Raphael Miguel testified by deposition as an expert for Dr. Puig. Dr. Miguel has been licensed to practice in Florida since 1984. He is board-certified in anesthesiology. Both Dr. Miguel and Dr. Gravenstein opined that based on the American Society of Anesthesiologists standards for monitoring that Dr. Puig was not required to monitor the temperature of T.M. during surgery because there was a low expectation that there would be a clinically significant change in T.M.'s temperature. The testimony of Drs. Miguel and Gravenstein is credited. At the final hearing, Dr. Sanchez-Salazar testified that it was a violation of the standard of care to leave a blood pressure cuff on a patient who is having surgery when the blood pressure cuff is not working and that Dr. Puig violated the standard of care when he left the blood pressure cuff on T.M.'s right arm. When questioned by counsel for Dr. Puig at his deposition taken on August 17, 2010, Dr. Sanchez-Salazar testified that it was not a violation of the standard of care to leave the blood pressure cuff on T.M. However, when Dr. Salazar was questioned by the Department's counsel in the same deposition, he opined that it was a violation of the standard of care to leave the blood pressure cuff on T.M. Dr. Sanchez- Salazar's testimony concerning leaving the blood pressure cuff on T.M. lacks credibility. It is Dr. Gravenstein's opinion that Dr. Puig did not violate the standard of care when he disconnected from the monitoring device, but did not remove the blood pressure cuff from T.M.'s right arm. It is his opinion that most people in the same situation would not remove the blood pressure cuff, because it would be difficult to remove the blood pressure cuff without violating the sterile field. A violation of the sterile field would risk infection of the surgical site. In balancing the need to remove a blood pressure cuff that is not inflated against the need to keep a sterile field, the anesthesiologist should leave the deflated blood pressure in place. Dr. Gravenstein's testimony is credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Puig did not violate section 458.331(1)(t) and dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of March, 2011, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of March, 2011.
The Issue Whether Respondent, in treating Patient #1 in 1987, failed to practice medicine with that level of care, skill, and treatment which a reasonably similar physician recognizes as acceptable under similar conditions and circumstances; and whether Respondent failed to keep written medical records justifying the course of treatment of Patient #1.
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. Respondent graduated from the University of Tehran in 1961; interned at Grace Hospital in Detroit, Michigan, in 1961-62; took Residency in Internal Medicine in 1962-65; and a Fellowship in Cardiology in 1965-67, the latter two in Detroit hospitals. He is not board- certified in Cardiology. Patient #1 (hereinafter designated as "Patient") was referred to Respondent by Dr. Barker, the company physician for General Electric Company in Largo, Florida, where Patient was employed on July 23, 1976. Patient's chief complaint was a recent weight gain, tiredness, headaches and high blood pressure. Following a physician examination of the patient, the impression of hypertension was recorded (Exhibit 2), laboratory tests were performed which included a thyroid profile; and Hydrodiruil, 50 mg., was prescribed. At a second visit one week later (July 30) Hypothyroidism was documented, a thyroid scan was ordered and Patient was told to return in one week. Patient was thereafter seen by Respondent on August 10, 1976; September 7, 1976; October 12, 1976; January, March, July and October 1977; January, April, June and November 1978; February, May and December 1979; March, June and September 1980; January, April, July and October 1981; January, April, July, September, October, November and December 1982; February, March, April, May, August, September, October, November and December 1983; January, March, April (3), June, August and November 1984; February, May, August and November, 1985; February, April, May, June, July and October 1986; January, February and March (2), 1987. In January 1982 Patient reported pain in the right shoulder and neck region. In July he reported chest pain and was prescribed nitroglycerin. In November he again reported three to five minute chest pains. No significant changes were reported in 1983. Patient was taking Synthroid daily during this period. Although not reported in doctor's notes, on December 4, 1984, a routine electrocardiogram reviewed by Dr. Paul Phillips was reported as abnormal (Exhibit 2, page 72). On the May 13, 1986, visit, a stress test was ordered for Patient which was administered 5/21/86. The test was stopped after 6.2 minutes because the exercise resulted in leg fatigue and shortness of breath. The report (Exhibit 2, page 55) shows: I. Limited aerobic capacity; II. Normal resting and exercise EKG, and III. No detectable symptomatic ischemic heart disease. A subsequent EKG taken January 7, 1987, viewed by the same doctor, was reported as abnormal (Exhibit 2, page 26). The January 15, 1987 entry in Exhibit 2 states EKG with no change. No additional tests were ordered. During the period after January 1987, the patient began experiencing more chest pains and inability to withstand exertion, although Respondent's notes for the February 23, 1987, visit states "EKG normal, walks three miles a day with no problem in the past two weeks." This information can only have come from the patient and tends to refute the patient's wife's testimony that Patient was experiencing severe chest pains in February 1987. On the other hand, the wife testified that in February 1987 they visited a son in Atlanta, Georgia, and the patient and his son went to the park to exercise. The first day the patient walked briskly without discomfort, but his pulse did not rise. The following day when he attempted the same walk, the pain was so severe he could not walk. On March 2, 1982, as noted in Exhibit 2, Patient still complained of lower sternal discomfort. An echocardiogram was ordered which, as best I can read the handwritten notes (Exhibit 2, page 40) indicates normal findings. Patient returned to Respondent's office on March 10, 1987, complaining of chest pains on and off. Procordia was ordered, and Patient was directed to return in one week. On March 11, 1987, Patient went to work as usual. When he didn't telephone his wife to say he had arrived safely, the wife called the patient who reported he had great difficulty walking from his parked car to the office and that he was in a lot of pain. On March 12, 1987, Patient did not go to work. Sometime that morning, either Patient or his wife telephoned Respondent but were unable to reach him. Word was left for Respondent to call. The call from Respondent came around 10 p.m., March 12, and Patient was advised to go to the hospital. Patient was admitted to the emergency room at Humana Hospital, St. Petersburg, Florida, at 11:53 p.m., March 12, 1987, after arriving at 10:45 p.m. On March 13, 1987, Patient had occasional chest pains and cardiac enzymes were elevated. He was medicated with Inderal, Isurdil, Xanax, Morphine and Zantac. The hospital medication chart (Exhibit 3, page 15) shows Patient was administered Nitroglycerine at 0330, 0805 and 1830; that he was administered Morphine Sulphate at 0923 and 1530; Demoral at 0810; Lasix at 1930; and Heparin at 1940. Exhibit 3 on page 16 indicates Patient received Inogral, Isordil, Maalox, Zomax, Zantac and Tigen, but does not indicate when. Exhibit 3, Page 17 indicates Patient received D5W, Dopamine, Heparin, Lanoxin and Varapimal on March 13, 1987. The patient remained in the Emergency Room until 2030, March 13, due to no bed available. He apparently suffered a massive heart attack around 7:45 p.m. while in the Emergency Room. Nurses notes for March 13, 1987, indicates Patient was sleeping during the early morning hours, was given Nitroglycerine at 0330 for chest pain and Morphine Sulphate at 0400; at 0730. Patient appeared in no discomfort; at 0805. Patient complained of pressure sensation in midsternal area and was medicated with Nitroglycerine but continued to complain of chest discomfort and was given Demoral; at 0930 Patient complained of heart burn after eating breakfast relieved with burping; at 1010 Patient complained of slight chest pressure, given Nitroglycerine; seen by Respondent and wife at 1045 and 1400; 1530 complained of pain and was given Morphine Sulphate; 1815 vomited two basins full; 1830 Patient sweating profusely (diaphoretic), given Nitroglycerine, and at 1845 Morphine Sulphate for chest pain and discomfort; at 1850 an emergency EKG was done and Respondent was paged; at 1905 EKG reviewed and Dopamine drip began; at 1920 Dopamine drip increased 10 cc.; 1930 Lasix administered; 1940 Heparine administered, 7500 units IVP; 2000 Dopamine increased to 15 cc.; 2015 Lanoxin given and Dopamine increased to 25 cc.; 2030 patient vomited approximately 500 cc. reddish fluid; 2035 Verapamil given; 2110 Lanoxin 25 mg. repeated and Dopamine increased to 35 cc.; 2125 patient extremely restless, respiration labored - Valium and Atropine given; and code called. Discharge summary shows that at 1945 Patient developed acute respiratory distress, profuse perspiration and no chest pain. The patient was intubated, subclavian catheter was inserted in the right atrium, Patient was given full CPR, Epinephrine injection and intravenous bicarbonate. Patient expired at 2219. Petitioner's expert witness opined that prior to January 1987 Respondent's treatment of the patient met the prescribed standard of care for physicians, but subsequent thereto it did not. This opinion is predicated upon the worsening of Patient's condition in January, February and March 1987. Although there was an abnormal EKG in 1984, no evidence was presented that this EKG changed when subsequent EKGs were taken. Respondent's notes state no change in the EKGs taken through January 15, 1987. The entry made January 15, 1987, specifically found no change in EKG. Abnormal EKGs were reported in 1984 and on January 7, 1987. No evidence was presented to contradict the July 15, 1987, entry that there was no change in the EKG. The increase in cardiac enzymes found March 13, 1987, is evidence that damage to the heart muscle had occurred. Petitioner's expert faults Respondent for not ordering an angiogram at this time to determine the condition of the blood vessels to and from the patient's heart. Despite the fact that Patient was at Humana Hospital which did not have a cardio-cath lab, Petitioner's expert opined that the patient should have been transferred to a tertiary care hospital in the area with such facilities. Respondent, on the other hand, contends that invasive procedures at that time would have been fatal to this patient. In his testimony Respondent opined that the patient had chronic stable angina before he was even forty. Further, that the patient fit in the category of the population with a single coronary artery disease that have a malignant course; that this patient, who had this type of artery disease, was foredoomed to die, and nothing could have saved him, and that any invasive procedure would have resulted in the death of the patient. Respondent contends that the autopsy report confirms this opinion. Despite this testimony a majority of the publications presented by Respondent as late-filed exhibits contained discussions regarding the treatment of patients with unstable angina. Petitioner's expert witness opined that the rapidly deterioration of the patient on March 11, 1992, clearly demonstrated the patient needed to be hospitalized and invasive procedures initiated to determine the condition of the patient's arteries. It is the failure to initiate such procedures that rendered the treatment of this patient below the minimum acceptable standards of treatment recognized by a reasonably prudent similar physician as being acceptable under similar circumstances and conditions. Petitioner's witness further opined that the physician's records regarding this patient were insufficient to justify the course of treatment of the patient. This opinion was based upon the fact he found Respondent's records "rather limited, often almost illegible, and did not really reflect the collection of subjective and objective data that could lead one then to follow the process of evaluation and management of either gastrointestinal problems or cardiac problems." He further concluded that these records did not reflect a cardiac diagnosis of the patient.
Recommendation It is recommended that a Final Order be entered finding Si H. Azar guilty of violation of Section 458.331(t) and not guilty of violating Section 458.331(1)(m), Florida Statutes; that he be placed on probation for a period of three years under such terms and conditions as the Board of Medicine deems appropriate; and that he be required to take additional continuing education courses in the use of invasive procedures and in diagnosis and treatment of cardiac patients. ENTERED this 2nd day of, July 1992, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of July, 1992. COPIES FURNISHED: Michael K. Blazicek, Esquire Jack McRay, Esquire Department of Professional General Counsel Regulation Department of Professional 730 S. Sterling Avenue Regulation Tampa, FL 33609-4582 1940 N. Monroe Street Suite 60 Si H. Azar Tallahassee, FL 32399-0792 3820 Gulf Boulevard, Apt. 1003 St. Petersburg Beach, FL 33706 Dorothy Faircloth Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792
