The Issue Whether disciplinary action should be taken against Respondent's license to practice as a physician, license number ME 67443, based on a two-count violation, Sections 458.331(1)(m) and (t), Florida Statutes, as alleged in the Administrative Complaint filed against Respondent in this proceeding.
Findings Of Fact Based on the evidence and the testimony of witnesses presented in this proceeding, the following facts are found: Respondent is, and has been at all times material hereto, a licensed physician, having been issued license number ME 67443 by the State of Florida. At all times material hereto, Respondent practiced as an emergency room physician. When treating a patient, an emergency room physician has a duty to rule out the most serious life- threatening conditions. Pulmonary embolism is a blood clot, which forms in or travels to the lungs. It is a life-threatening condition. A thrombus is a blood clot that forms at a particular site, while an embolus is a piece of a thrombus that breaks off and wedges itself in another artery. The most common type of thrombus that causes pulmonary embolism is a deep vein thrombus, which originates in the lower extremities (legs). Once a thrombus forms in the leg, an emboli can break off from the thrombus, travel through the bloodstream and wedge itself in the lungs, creating a pulmonary embolism. On June 13, 1995, Patient R.D. presented to the emergency room of the Daytona Beach Medical Center in Daytona Beach, Florida, at approximately 7:35 p.m. Patient R.D. was a 41 year-old obese male who weighed 305 pounds. Patient R.D. presented to the emergency room complaining of chest pain (rated 3-4 on a scale of 10) and shortness of breath beginning at 8:30 a.m. that day. The patient was seen by a nurse who prepared a "triage nursing assessment." The nurse documented the following about Patient R.D.: Chief complaint of nausea and diaphoresis (cold sweat) earlier in the day; pulse rate of 112, which indicated tachycardia; elevated respiratory rate of 28; labored breathing; clear breath sounds; and trace pedal edema. The "Implementation: Nursing Action" noted that Patient R.D. had marked dyspnea (labored breathing). He was immediately placed on oxygen. At 7:40 p.m., Respondent, the emergency room physician on duty, examined Patient R.D. During Respondent's subjective examination of Patient R.D., Respondent documented: Chest pain all day, heaviness in the center of the chest with some nausea, negative vomiting; negative numbness and sweating; negative history of this [sic]; positive shortness of breath all day with chest pain, but can work; negative history of asthma; negative history of heart disease; family history positive for cardiac disease (mother in her 60's); social history (smoked a joint 24 hours ago). The patient reported that despite his complaints, he was still able to work. Patient R.D. was obese and had recently smoked marijuana, two of the secondary risk factors associated with pulmonary embolism. Patient R.D. did not present to Respondent with the classic signs and symptoms of pulmonary embolism. While taking Patient R.D.'s history, Respondent did not document any history of cholesterol levels, cigarette smoking, recent leg injury, prior blood clots, or sedentary time periods. Respondent failed to document important aspects of Patient R.D.'s family and social history. Respondent failed to adequately document the history taken. Respondent performed a complete physical examination of the patient, including an examination of his legs. During Respondent's objective examination of Patient R.D., Respondent documented: lungs clear to auscultation (no rattles or wheezing) with good alveolar BS bilaterally; cardiac S1S2 and distant; abdomen obese and negative tender; legs with 1+ pedal edema; negative CVA tender (no tenderness over kidneys); no nuchal rigidity (no neck stiffness). The patient had no diaphoresis in the emergency room. Respondent then ordered a chest X-ray, an electrocardiogram (EKG), blood work (CBC), and electrolyte panel and cardiac enzymes. Respondent also had a pulse oximetry performed. Major risk factors of pulmonary embolism include: history of malignancy, recent leg injury, prior blood clots including deep vein thrombosis, and sedentary time periods. Secondary risk factors include: obesity and smoking, including marijuana smoking, and elevated cholesterol levels. The signs and symptoms of pulmonary embolism include, but are not limited to, shortness of breath, chest pain or pressure, diaphoresis (sweating), increased respiratory rate, and tachycardia (abnormal rapid heart rate). Although Respondent testified that he considered pulmonary embolism as one of his top five differential diagnoses, the patient's clinical signs and symptoms were insufficient for Respondent to have to rule out a pulmonary embolism. As the signs and symptoms of a pulmonary embolism can wax and wane, it is not an easy diagnosis to make. When examining the legs of a patient suspected of having a pulmonary embolism, the standard of care requires a physician to look for swelling, edema, tenderness and a cord, which would be a clotted vein. In order to determine tenderness, a physician must palpate the legs of the patient. Also, when examining the legs, a physician should perform an examination by stretching the calf to look for tenderness (called Homan's sign). Respondent performed a palpation of the patient's legs, but did not perform an examination for Homan's sign. Respondent's physical examination of Patient R.D. was adequate under the circumstances. The standard of care requires that a physician document pertinent positives and negatives in the medical records. Swelling, edema, tenderness and results of palpation are pertinent positives and negatives. Although Respondent performed an adequate physical examination of Patient R.D., Respondent failed to adequately document the physical examination. In this case, the pertinent positives or negatives should have included the results of the leg examination including, but not limited to, swelling, tenderness, palpation for cords and tenderness, and motion of the foot. Specifically, Respondent did not document whether he palpated the legs of Patient R.D., or whether the examination revealed any swelling or tenderness in the legs. Moreover, Respondent did not document Patient R.D.'s respiratory status. Also, Respondent did not document any history of deep vein thrombosis (DVT), which is a pertinent positive or negative. An EKG reveals the rhythm of the heart. Respondent ordered an EKG and reviewed the computer printout of the EKG results, which revealed non-specific ST changes. Respondent noted the non-specific ST changes in his notes. The EKG also revealed sinus tachycardia and S1-Q3-T3 changes. Tachycardia on an EKG is abnormal, unless the cause is determined. In order to treat tachycardia, a physician must determine the underlying cause, which directs the physician to the appropriate treatment plan. Respondent did not determine the underlying cause of Patient R.D.'s tachycardiac condition. S1-Q3-T3 reveals a strain on the right side of the heart. Respondent did not document the tachycardia or S1-Q3-T3 changes, or determine their underlying cause. Respondent did not recommend admission for Patient R.D. even though Patient R.D. had an abnormal EKG. Respondent also ordered blood work, a chest X-ray, and a pulse oximeter test. Respondent and the Radiologist interpreted the chest X-ray as negative. The patient's pulse oximeter initially revealed a 91 percent rating, a subsequent pulse oximeter revealed a 92 percent. A 91-92 percent pulse oximeter is low in a 41 year-old male, unless the patient has a long standing history of chronic lung disease. Respondent did not order arterial blood gases or a lung scan for Patient R.D. An arterial blood gas test is more accurate than a pulse oximeter. Respondent should have ordered an arterial blood gas only if the pulse oximeter did not improve. After the breathing treatment, Patient R.D.'s pulse oxmeter was 96 percent, which is a significant improvement. A physician must order a lung scan after looking at a constellation of all factors put together, including increased heart rate, low pulse oximeter, increased respiratory rate, abnormal EKG and symptoms of chest pain and shortness of breath. Respondent did not order a lung scan for Patient R.D., even though it could have been ordered. A lung scan is the standard regimen for diagnosing a pulmonary embolism. At approximately 8:00 p.m., Patient R.D. was nauseated and vomited light green bile. Respondent treated Patient R.D. with Proventil, a nebulizer, which is used to treat and relieve bronchospasms. Patient R.D. felt better after the Proventil treatment. Respondent diagnosed Patient R.D. with Hyperactive Airway Disease and Diabetes. Although an emergency room physician does not admit patients, an emergency room physician can recommend to the private physician that a patient be admitted for further evaluation. A private physician relies heavily on the information presented by the emergency room physician. If the private physician disagrees with the emergency room physician recommendation, then the private physician must come to the hospital to personally examine and discharge the patient. Respondent contacted the patient's family physician, advised him of the patient's condition, but did not recommend Patient R.D. be admitted. In the early morning hours of June 14, 1999, Patient R.D. died as a result of a bilateral pulmonary embolism. Respondent's care and treatment of this patient was supported by the testimony of two experts. They indicated that the major risk factors for pulmonary embolism are malignancy, surgery or any trauma to the long bones; none of which were present in this case. The secondary risk factors are pregnancy, cigarette smoking and obesity. Pulmonary embolism is seen most often in orthopaedic surgery patients and, secondarily, in patients with fractured long bones or multiple trauma including the lower extremities. The only sign and symptom that is seen with any regularity in the presentation of pulmonary embolism patients is shortness of breath. Other signs and symptoms occur with such infrequent regularity as to be non-specific and can occur in a plethora of other illnesses. Patient R.D. did not have any of the primary risk factors for pulmonary embolism and any reasonable physician would not think of pulmonary embolism as a primary diagnosis or even as a conceivable diagnosis in a patient with these present symptoms. The experts agree that Patient R.D.'s relatively minor complaints of shortness of breath would have even given Respondent a clinical suspicion of pulmonary embolism. When examined, Patient R.D. was not diaphoretic or apprehensive, had normal color, with skin warm to the touch. The patient simply did not present as one in acute distress secondary to sudden pulmonary embolism as the Petitioner contends. At discharge the patient had improved so significantly that his oxygen saturation rate was near normal and respiration rate near normal. Dr. R. Latanae Parker had reviewed the autopsy and drew several conclusions from it. He interpreted the medical examiner's microscopic examination of the clot to indicate that they were "fresh" and mobilized within minutes of death. Dr. Parker testified that this patient died of a sudden death by a sudden pulmonary embolism that was massive enough to occlude blood flow such as there was not adequate profusion to the coronary system and to the cerebral system. Based on Patient R.D.'s condition before discharge from the emergency department, Dr. Parker testified it was not necessary for Respondent to have pulmonary embolism as one of his differential diagnoses or to have otherwise ruled out that condition. Petitioner has presented no credible testimony which would establish that the deep vein thrombosis (DVT) seen on autopsy was diagnosable in the emergency room by gross exam, palpation or otherwise. The DVT seen on autopsy was silent and, therefore, undiagnosable in the emergency room as Patient R.D. did not have a history of trauma, swelling, inflammation or discoloration of his lower extremities. The autopsy supports Dr. Parker's testimony because the leg circumferences were found to be equal and there was no indication of swelling, discoloration or evidence of trauma. Petitioner's standard of care expert, Dr. Jay Edelberg, provided testimony which actually refutes several allegations in Petitioner's complaint. Specifically, Dr. Edelberg agreed that Respondent's initial assessment of Patient R.D.'s heart was adequate and that Respondent did not ignore Patient R.D.'s cardiac status. Dr. Edelberg also agreed that it was not inappropriate for Respondent to have provided this patient with the Proventil breathing treatment and that a diagnosis of a chronic airway condition was unnecessary in order to treat with such nebulizer. Dr. Edelberg also agreed that Respondent accurately interpreted the EKG and chest X-ray and his findings were properly recorded in the chart. Respondent appropriately diagnosed Patient R.D.'s condition and pursued the appropriate plan of treatment of the patient's condition. Respondent appropriately evaluated the patient's history and complaints which the patient had provided to the triage nursing staff. Respondent performed an appropriate assessment of the patient in the emergency room including obtaining a history of his subjective complaints; his pertinent medical history; and an objective physical evaluation of the patient while in the emergency room. Respondent appropriately ordered the necessary tests to evaluate the patient's condition, based on his examination including an EKG, portable chest X-ray, blood chemical profile, complete blood count, cardiac enzymes and pulse oximeter test. Respondent appropriately interpreted the aforementioned diagnostic studies and tests in establishing his diagnosis and treatment of the patient. Respondent appropriately diagnosed the patient with hyperactive airway disease (i.e., bronchospasm) and properly treated that condition with Proventil while in the emergency room. Respondent appropriately diagnosed the patient with diabetes based on his elevated blood sugars and appropriately coordinated the treatment of that condition with the patient's family practitioner on the following day. Respondent appropriately assessed the patient's risk factors for pulmonary embolism, including his examination of the patient's legs to determine the presence of any signs of deep vein thrombosis. Respondent did consider the patient's report to the triage nurses that he had been diaphoretic earlier in the day. Respondent did consider the patient's complaints of chest pain and appropriately treated him for that condition. Respondent appropriately considered the patient's cardiac status and fully assessed the possibility that the patient's condition was of cardiac origin. Respondent appropriately interpreted and considered the non-specific changes in the patient's EKG in the course of his diagnosis and treatment of Patient R.D. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by not referring the patient to a cardiology or pulmonary specialist. Respondent appropriately discharged the patient from the emergency room, as admission to the hospital was not indicated under the circumstances based on the patient's significant improvement. Respondent's treatment plan for Patient R.D. was appropriate for his presenting complaints. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by gross or repeated malpractice or the failure to practice medicine with that level of care, skill or treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances in the case of Patient R.D. Respondent did not adequately maintain medical records which justified his plan of treatment for Patient R.D. to include the history; examination results; test results; drug prescribed, dispensed and administered; and documentation of his having conferred with Patient R.D.'s reported primary care physician.
Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Medicine enter a final order, in which: Respondent is found not guilty of violating Section 458.331(1)(t), Florida Statutes. Respondent is found guilty of violating Section 458.331(1)(m), Florida Statutes. Respondent be disciplined, as follows: Administrative Fine of $500.00. Reprimand. DONE AND ENTERED this 27th day of December, 1999, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 27th day of December, 1999. COPIES FURNISHED: Carol A. Lanfri, Esquire Kristy Johnson, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Art C. Young, Esquire Rissman, Wiesberg, Barrett, Hurt, Donahue & McLain, P.A. 201 East Pine Street, 15th Floor Orlando, Florida 32801 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1701 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact Petitioner, the Department of Business and Professional Regulation (now the Agency for Health Care Administration), is the state agency charged with enforcing the statutes and regulations governing the practice of medicine in Florida pursuant to Chapters 20, 55, and 458, Florida Statutes, and the rules and regulations promulgated pursuant thereto. Respondent, Alexander Sonkin, M.D., is a medical doctor licensed in Florida, having been issued License No. 0044838, and his principle place of practice is 11216 North Dale Mabry Highway in Tampa, Florida. Except for this proceeding, there is no evidence that Respondent has ever been the subject of disciplinary action in connection with his medical license. From approximately December 28, 1988, through June 7, 1989, Respondent treated Patient #1, a 70 year old male as a primary care physician. During Respondent's first encounter with Patient #1, on December 28, 1988, he performed a history and physical examination in preparation of Patient #1's entry into a weight reduction program. Based on Respondent's physical examination and history of Patient #1 on December 28, 1988, Respondent diagnosed Patient #1 as suffering from "degenerative joint disease, emphysema, glaucoma and arteriosclerotic heart disease". During the period in which Respondent was Patient #1's treating physician, there were six office visits for medical care. Patient #1's daughter-in-law, Mary Daly, often accompanied him to Respondent's office for treatment. On January 30, 1989, Respondent diagnosed Patient #1 as suffering from hemoptysis (coughing up blood) and chronic obstructive pulmonary disease (COPD). On the January 30, 1989, office visit, Respondent ordered an x-ray which was completed on that same day. The x-ray that was performed on Patient #1 did not reveal any evidence of pulmonary malignancy (lung cancer). The x-ray did, however, reveal that Patient #1 was suffering from COPD and basilar atelectasis but there was no evidence of a mass or malignancy. The primary diagnosis that family physicians usually consider, based on Patient #1's symptoms, would be chronic bronchitis which is the most common source for hemoptysis in the United States. Patients presenting with hemoptysis are difficult to diagnose as there are many different causes for the differential diagnosis of hemoptysis. Specifically, hemoptysis occurs with approximately equal frequency (30 percent) of patients who present with either lung cancer or those patients who present with pulmonary emboli. Respondent next treated Patient #1 on February 21, 1989, at which time he presented with a swollen left leg. A unilateral swollen leg is significant in that the deep veins of the legs are a possible source of clots causing pulmonary emboli. On that visit, there were no complaints or indication of continued hemoptysis at that time. Patient #1 was next treated by Respondent on April 18, 1989, at which time Respondent continued to treat him for COPD. On or about May 9, 1989, Patient #1 was again treated by Respondent for hemoptysis and COPD. On this second episode of hemoptysis, Respondent ordered a chest x-ray and he was hospitalized from May 9 through May 17, 1989. Respondent's diagnosis of Patient #1, upon admission to the hospital, was bilateral pneumonia but he was later diagnosed and treated as a patient suffering from pulmonary emboli and COPD. On May 24, 1989, Respondent again treated Patient #1 for a follow-up visit wherein he was again diagnosed as a patient suffering from COPD and pulmonary emboli. Patient #1's final visit to Respondent was on June 7, 1989, wherein he returned to Respondent's office to undergo blood work studies. Patient #1 was a 70 year old male during 1988 who had been a former smoker, however, he had not smoked for the preceding 15 years when he was first treated as a patient of Respondent. During one of the visits to Respondent's office, Respondent's daughter, Mary Daly, brought a plastic bag of blood which Patient #1 had coughed up. Patient #1 requested that Respondent's nurse send it to the laboratory for analysis. Respondent did not send the blood to the laboratory for analysis as he considered that to be useless in treating Patient #1. Respondent's nurse had a practice of recording everything that a patient complained of and these were reflected in the medical records for Patient #1. Respondent's records indicate that there were two instances wherein Patient #1 presented with hemoptysis and on those two occasions, January 30, 1989, and May 9, 1989, Respondent's records accurately indicate the episodes of hemoptysis. When Respondent treated Patient #1 during his hospitalization in May, 1989 for the bilateral pneumonia and the ultimate diagnoses of pulmonary embolism and COPD, Respondent administered the medications Heparin and Coumadin. Both Heparin and Coumadin are anticoagulants (blood thinners) and can be used to treat patients suffering from pulmonary emboli. Heparin is a fast acting anticoagulant which is usually used to treat people suffering from blood clots and who need rapid action in thinning their blood. Coumadin is used for patients who have been on anticoagulants for long periods of time. All of the experts agreed that a patient in otherwise good health, but who presents with a suspected pulmonary emboli, should be treated or investigated with an arterial blood gas work-up, a chest x-ray, and a Ventilation/Perfusion Scan (VQ Scan). These tests can assist a physician in determining whether a pulmonary emboli is the cause of a patient coughing up blood. All experts expressed an opinion as to whether Respondent deviated from the standard of care in treating Patient #1. 1/ A VQ Scan takes approximately 3 hours and other treatments, such as administering anticoagulants, cannot be safely done when the VQ Scan is being performed. The VQ Scan is an invasive procedure, and a patient undergoing a scan must be lying down throughout the procedure. Patient #1 was not a proper candidate for a VQ Scan based on his medical condition at the time that he presented as he was "fading fast" in the eyes of his doctor. When Respondent administered Heparin to Patient #1, his condition improved quickly and he was able to be released from the hospital within a week's time. Respondent's administration of anticoagulants was indicated for the treatment of a pulmonary emboli and Respondent adequately treated Patient #1 on May 9, 1989. On June 29, 1989, Patient #1 was treated by John G. Greene for a second opinion concerning hemoptysis which had occurred "off and on for a period of several months." This was of course subsequent to Respondent's last treatment of Patient #1. Dr. Greene retired and sold his practice sometime after he last treated Patient #1. He no longer has all of his patient records concerning Patient #1. At the time of his visit, Patient #1 told Dr. Greene that he had been coughing up blood periodically for several months. His daughter-in-law, Mary Daly, also told Dr. Greene that Patient #1 had been periodically coughing up blood. Dr. Greene performed a physical examination and took a medical history. Dr. Greene also determined that Patient #1 had been a heavy smoker approximately 15 years earlier in his life. Dr. Greene sent Patient #1 for a pulmonary work-up including a CAT Scan on the following day. Dr. Greene also ordered a bronchoscopy and a biopsy and made an immediate referral to a pulmonary specialist. The biopsy confirmed cancer approximately one week after his first visit to Dr. Greene. On or about December 25, 1989, Patient #1 expired due to adenocarcinoma of the lung. All of the experts agree that lung cancer is difficult to detect and diagnose as even the most thorough practitioner who utilizes a battery of tests, including a CAT Scan and an MRI, usually cannot detect lung cancer until the growth has reached approximately one centimeter. The experts also agree that a patient, when properly diagnosed with lung cancer, usually has less than a year to live. The experts also all agree that in medically treating a patient who had been a former smoker but who had not been smoking for a period of 15 years or more, would be treated as a nonsmoker since all of the medical problems related to smoking would no longer be evident. Petitioner subpoenaed copies of Respondent's records of his treatment of Patient #1. Upon obtaining Petitioner's request, Respondent reviewed the records and made certain specific findings and additions to the records relative to his recall of specific symptoms and other treatment modalities that he used for treating Patient #1. Respondent admits that he made these specific changes and additions so that the medical records would be complete. The changes were not made for any improper purpose and his treatment modalities, other than the specifics, remain unchanged.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: Petitioner enter a final order dismissing the Administrative Complaint filed herein in its entirety. DONE AND ENTERED this 31st day of October, 1994, in Tallahassee, Florida. JAMES E. BRADWELL 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 31st day of October, 1994.
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, in that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, by failing to treat the patient's preoperative coagulopathy and/or failing to use an alternate vein that would have allowed visualization of the shunt placement into the vein thereby reducing the risk of causing a hemorrhage given the patient's preoperative history, and, if so, what penalty should be imposed. AS TO CASE NO. 01-4407PL Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to distally clamp part of the arteries prior to manipulation of the aneurysm and by failing to ensure periodic monitoring of the patient's condition postoperatively for evidence of ischemia or other problems and, if so, what penalty should be imposed.
Findings Of Fact Based on the evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: FACTS COMMON TO BOTH CASES Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapters 456 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0036360. Respondent is board-certified in thoracic and general surgery. FACTS RELATED TO CASE NO. 01-4406PL Patient D.J.P. was a 54-year-old female with a history of liver resection for carcinoma. Patient D.J.P. had contracted Hepatitis C in the 1960s from a blood transfusion, after being the victim of a gun shot wound during a robbery at a convenience store. Patient D.J.P. subsequently had developed cirrhosis secondary to the Hepatitis C. Cirrhosis is a scarring process of the liver that results in the displacement of the normally functioning liver tissue. A healthy liver processes lymphatic fluid back into the bloodstream. However, a cirrhotic liver cannot properly process the lymphatic fluid back into the bloodstream. Therefore, lymphatic fluid backs up within the liver and weeps out the covering over the liver and into the abdominal cavity. Patient D.J.P. presented to Respondent on February 1, 1994, after being referred to Respondent by Michael Carey, M.D., the primary care physician, for evaluation for implanting a peritoneal venous shunt. A venous shunt is a conduit designed to take ascitic fluid from the abdomen and put it back in the vascular system. The shunt removes the fluid from the abdominal cavity and transports it to the vascular system where it can be absorbed. The procedure is for the patient's comfort and does not prolong the patient's life. The procedure is for patients with end stage liver disease. After obtaining a medical history and conducting a physical examination, Respondent's assessment of the Patient D.J.P. was massive ascites secondary to cirrhosis and previous liver resection. Respondent believed that Patient D.J.P. was a candidate for a venous shunt procedure due to the fact that she was very symptomatic from her massive ascites and she was on the maximum medical therapy. The mortality rate for this type of procedure is between 5 and 25 percent or at the very least, one-in-twenty patients would die from this procedure. Complications associated with this type of procedure include disseminated intravascular coagulopathy (hereinafter referred to as "DIC") which may lead to the general worsening of the disease or death. The patient was informed of this mortality rate as well as of the complications associated with this procedure. Patient D.J.P. decided to think about the procedure and contact Respondent's office when she wanted the shunt inserted. On February 10, 1994, Patient D.J.P. called Respondent's office and asked to have the shunt inserted as soon as possible. Respondent scheduled the procedure for February 14, 1994, and signed the written surgical consent form. Prior to the surgery, lab tests were performed on Patient D.J.P. The lab report indicated that the patient's prothrombin time was 14.3, with a normal range being 10.7-12.8. Prothrombin time ("PT") is a measurement of one aspect of the blood clotting mechanism. This was considered slightly abnormal and not an indication of a clotting problem or coagulopathy. Respondent decided it was not necessary to address Patient D.J.P.'s abnormal PT prior to the procedure by preoperatively administering Vitamin K or fresh frozen plasma. On February 14, 1994, Patient D.J.P. was transported to the operating room at approximately 12:10 p.m. After Patient D.J.P. was placed under general anesthesia, Respondent began the venous shunt operation at approximately 12:34 p.m. Respondent attempted to access the right jugular vein to insert the shunt. He found this vein to be unusable because it was too scarred from previous surgeries. Respondent then proceeded to access the right subclavian area to insert the shunt. Once the shunt was inserted into the subclavian area, Respondent positioned it in the superior vena cava. The shunt was noted to be in position in the superior vena cava. Respondent then removed eight liters of ascitic fluid from the abdominal cavity. After removing the ascitic fluid, he then put one liter of saline into the abdominal cavity to dilute any remaining ascitic fluid which allowed any remaining fluid to be more easily absorbed into the vascular system. The Patient's central venous pressure dropped from 8 to 2. Hespan and Albumin were then administered to replace any lost volume and it helped to increase the colloidomotic pressure. At this point, Patient D.J.P.'s central venous pressure (CVP) increased from 2 to 14 or 15. This is a faster than normal rate. Upon finding that the shunt was operating well, Respondent closed the abdominal portion and the patient was extubated. Petitioner claimed that fluoroscopy was not used to ensure that the shunt was positioned in the proper place. A Fluoroscope is like a real-time X-ray. A fluoroscope has two parts to it: a C-arm, which goes above the patient and underneath the bed, and two screens where the doctor can see what is going on. The C-arm is approximately 5-and-a-half feet tall. It is below the standard of care to do a venous shunt procedure without using a fluoroscope. It would enable Respondent to visualize the placement of the shunt. Felicia Whitmer, a scrub technician, and Rene Myers, a circulating nurse, prepared the operating room for Patient D.J.P.'s procedure on February 14, 1994. Both Felicia Whitmer and Rene Myers testified that there was no fluoroscope in the operating room on February 14, 1994. Respondent testified that there was a fluoroscope in the operating room on February 14, 1994, during Patient D.J.P.'s procedure and that he used it to assist him. The evidence is not clear and convincing that the fluoroscope was not used during the course of the operation. It is considered within the accepted standard of care to access the right subclavian vein to insert a shunt of this type because this vein follows a gentle curve or path. With this gentle curve in the vein, there is less risk of damage, i.e. puncture, to the vein. In contrast, the left jugular vein follows a more sharp-angled 70-degree bend-curve in the vein where one risks the danger of the shunt coming out of the bottom of the vein or perforation and, thereby, damaging the vein. Respondent ordered an X-ray to confirm placement of the shunt and catheter. The X-ray revealed that the shunt had good positioning but the right lung was filled with fluid. The patient was re-intubated and Respondent inserted a chest tube into the patient which would expand the patient's lung, oxygenate the patient and allow for fluid removal. Three or four liters of fluid were removed. The fluid was originally serous and pink tinged and shortly thereafter, turned bloody. Respondent noted that there was bruising around the wounds. Additionally, the patient's breathing became shallow and her blood pressure began to deteriorate. Resuscitative efforts were performed and Respondent re- entered the shunt area to clamp the shunt to prevent any ascites from flowing into the venous system and to prevent further coagulation and massive bleeding. Despite heroic resuscitative efforts, the patient's condition continued to deteriorate and the patient died. The cause of death was determined to be DIC and severe coagulopathy from drainage of the ascitic fluid into the venous system. Respondent made the determination that the patient did not have preoperative coagulopathy. Respondent testified that if the patient did have preoperative coagulopathy, he would not have performed the procedure because the patient would not be able to make the clotting factors well enough for problems that would occur after the shunt was inserted. It was Respondent's opinion that the patient did not have a serious clotting problem. Based on her lab report, Patient D.J.P. had a slightly abnormal PT and this was not an indication of a clotting problem. Respondent reviewed the lab reports and determined the PT (the measurement of one aspect of blood clotting mechanism), to be only slightly elevated. It measured 14.3 with a normal range being 10.7-12.8. Moreover, the PT International Normalized Ratio (INR) (which is the standardized measurement of PT) was 1.63 where the therapeutic range was 2-3. Therefore, this was slightly below average. Dr. Yahr testified that an abnormal clotting problem is a clinically evident problem and not an incident of a lab number. If Patient D.J.P. had a clotting abnormality, adverse conditions or symptoms would have been evident with the incisions that were made prior to the shunt being opened. Rather, normal clotting reactions occurred. Coagulation occurred right after the shunt was opened and the ascitic fluid began to flow into the atrium. Dr. Yahr testified that the etiology of the coagulation was the body's reaction to the ascitic fluid after the shunt was opened. Accordingly, it was Dr. Yahr's opinion that Respondent did not fail to treat the preoperative coagulopathy because upon his examination of the patient, he determined that no such preoperative coagulopathy existed prior to the procedure. Dr. Yahr testified that the patient did not have abnormal bleeding. Her liver failure was the result of scarring and abnormal liver function. Therefore, administration of clotting factors such as Vitamin K and fresh frozen plasma was not indicated or medically necessary. Petitioner presented the expert testimony of John W. Kilkenny, III, M.D. Dr. Kilkenny is board-certified in general surgery and has been for 11 years and is currently a professor with the University of Florida College of Medicine, Department of Surgery in Jacksonville, Florida, a position which he has held for the last six years. According to Dr. Kilkenny, Patient D.J.P.'s elevated PT was a cause for concern in that it was an indication that the patient's ability to clot or coagulate was diminished. It is not clear and convincing that the standard of care required that the elevated PT be treated by infusing fresh frozen plasma or Vitamin K. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by failing to use an alternate vein that would allow visualization of the placement of the shunt. Respondent first attempted to access the right jugular vein to insert the shunt but found it be unusable because it was too scarred. Respondent, acting as a reasonably prudent physician and using sound medical judgment, accessed the right subclavian area to insert the shunt. After the shunt was inserted into he subclavian vein, Respondent claimed he was able to visualize the placement of the shunt by the use of fluoroscopy. Furthermore, the operative notes seemed to indicated that the procedure was performed under fluoroscopic control and the shunt was found to be in position. Therefore, Respondent accessed an appropriate alterative vein-the subclavian vein, which allowed visualization, with the assistance of fluoroscopy, of the placement of the shunt. As to the second issue, Dr. Kilkenny opined that the standard of care requires direct visualization for insertion of the shunt. By not accessing a vein under direct visualization, such as with Respondent's subclavian approach, the surgeon is, in essence, hunting for the vein, and risking damage to the wall of the vein that may not be evident immediately. The rapid rise in CVP from 2 to 14 or 15 was also a concern for Dr. Kilkenny because it was not normal, and did not mean that the shunt was placed correctly of that the shunt was functioning properly. Dr. Kilkenny noted that it was unlikely that the bleeding in the chest cavity was caused by damage to an intercostals vessel when the chest tube was inserted because the chest X-ray that was taken prior to insertion of the chest tube showed a complete opacification of the right side and a shifting of the major vessels within the middle of the chest over to the left side. According to Dr. Kilkenny, the chest X-ray indicated that there had already been some sort of bleeding in the right chest prior to the insertion of the chest tube. Dr. Kilkenny disputed Respondent's theory that Patient D.J.P. died as a result of DIC. Dr. Kilkenny asserted that Respondent fell below the standard lf care in that, given Patient D.J.P.'s rapid decompensation, he failed to consider whether the patient's subclavian vein had been damaged, a condition which could have been addressed surgically. Dr. Yahr opined that Patient D.J.P. died of DIC that occurred within a short period of time after Respondent opened up the shunt and ascitic fluid was introduced into the atrium of the heart. Although Dr. Yahr further admitted that the bleeding in the chest could have occurred as a result of damage to the subclavian vein, and that it was below the standard of care to access the subclavian vein without using fluoroscopy, the evidence is not clear and convincing that either event occurred. It is found that Petitioner has failed to establish by clear and convincing evidence that the standard of care required Respondent to use an access site that allowed direct visualization of the placement of the shunt into the vein, or that Respondent failed to use fluoroscopy in order to directly visualize insertion of the shunt into the subclavian vein. AS TO CASE NO. 01-4407PL On August 22, 1997, Patient H.H., a 55-year-old female, was diagnosed with an abdominal aortic aneurysm measuring approximately 4.5 cm transverse diameter and beginning approximately 1-2 cm below an enlargement or swelling, of a blood vessel resulting in a weakening or thinning out of the vessel wall. On November 28, 1997, Patient H.H.'s aneurysm had grown to 5 cm within a three-month period and was occluded with partial thrombosis with a true lumen around 2.7 cm and extended down to the bifurcation of the abdominal iliac. This put the patient at risk for rupture of the aneurysm. Thrombosis is a blood clot within a vessel or within the vascular system. It does not embolize (travel) from another part of the body. It starts in a particular vessel and causes its damage from there. It is an acute clot that occurs in the vessel secondary to stasis (non-moving ) or some kind of coagulation or clotting deficiency or abnormality. Thrombotic activity most often begins by occluding the smaller vessels in the vascular system, such as those smaller veins located in the feet. On December 2, 1997, Patient H.H. first met with Respondent, who performed a complete medical history and physical examination and confirmed the presence of a 5 cm abdominal aneurysm. Patient H.H. was a 55-year-old female who smoked 1- and-a-half packs of cigarettes per day, had a blood pressure of 182/104 despite the fact that she was taking 50 mg Atenolol for hypertension (high blood pressure), and had a 30 percent blockage of the coronary artery. Previously, she had a cardiac catheterization, followed by an angioplasty of the femoral vessel in her left leg. Patient H.H. advised Respondent that her legs gave out on her after she walked two blocks, but that she did not have associated chest pain. Respondent confirmed earlier diagnosis of Patient H.H.'s medical condition as single vessel coronary artery disease, abdominal aortic aneurysm, hypertension, and claudication with femoral occlusive disease. Respondent also found diminished femoral pulses and palpable Dorsal pedal pulses present in both feet. Patient H.H.'s medical records indicated that this smoker of 30 years suffered from diabetes, peripheral vascular disease, intermittent clottication of the leg, hypertension, atherosclerotic disease, hypercoagulopathy, anthithrombin III deficiency, high cholesterol, and diminished protein and pH levels. Respondent prescribed prescription medication, Procardia to lower Patient H.H.'s blood pressure and Zyban to help her stop smoking. He recommended that the patient return in a week for follow-up. On December 15, 1997, Respondent continued to prepare Patient H.H for surgery. He again advised her to stop smoking and to purchase and take medication to help her stop smoking. Patient H.H.'s blood pressure was lower, 144/84, and although she had not purchased or taken the medication, she reduced her smoking down to one-half pack of cigarettes per day. Respondent then advised Patient H.H. to make plans to undergo the abdominal aortic aneurysm ("AAA") repair. Patient H.H. informed Respondent that she wanted to wait a little longer while she made financial arrangements to pay for the surgery. Respondent advised Patient H.H. to completely quit smoking before the surgery and advised her to return in one month for additional preoperative evaluation. On January 12, 1998, Respondent continued to prepare Patient H.H. for surgery by ordering a cardiac clearance (thallium evaluation) of the patient's heart to ensure she could tolerate the surgery before attempting the AAA repair. On February 3, 1998, Patient H.H. presented for the thallium evaluation of the heart and, on February 9, 1998, obtained cardiac clearance for repair of the AAA. On February 11, 1998, Respondent continued to prepare Patient H.H. for AAA surgery and suggested she donate two units of blood which would be used during the surgical procedure. Respondent scheduled AAA repair surgery for March 6, 1998. Respondent advised Patient H.H. of the risks associated with AAA surgery and specifically mentioned the risk of a heart attack, bleeding, kidney damage and loss of legs. He also advised that the risks associated with intra-operative AAA repair include spontaneous rupture, embolization of material from the wall distally, myocardial infarction, bleeding, injury to viscera of the small vessels, devascularization of the colon causing ischemic colitis, death, kidney blockage. Patient H.H. indicated she understood the risks and despite the risks associated with this type of surgical procedure, including the risk of death, she agreed to the procedure. Preoperative testing by angiogram was not required for Patient H.H. The aneurysm was a massive aneurysm presenting a very serious health risk of imminent rupture. The size of Patient H.H.'s aneurysm (5 cm) made AAA repair an emergency in a sense because there was almost a 100 percent chance of rupture with in the next six months. Any findings determined by angiogram would not have changed the outcome of the case because Respondent had to definitively treat the aneurysm first. Additionally, an angiogram is a very expensive test and Patient H.H. expressed a concern about her financial situation with respect to the AAA repair. It is reasonable to not do studies that a physician does not feel are absolutely necessary. The patient's financial concerns are part of the pathology. On March 6, 1998, Patient H.H. was admitted to Winter Haven Hospital and filled out and signed the Special Authorization for Medical and/or Surgical Treatment form indicating her consent to the surgical procedure which Respondent was to perform. She indicated that she understood the risks associated with such surgical procedure. Paragraph two of the informed consent form states in pertinent part: I hereby certify that I have given complete and informed consent for the above named operation and/or procedures, and Dr. L. Thomas has explained to me the reason why the above-named operation and/or procedure are considered appropriate, its advantages and possible complication, if any, as well as possible alternative modes of treatment. I also certify that no guarantee or assurance has been made as to the results that may be obtained. The operative procedure on the consent form was signed by Patient H.H. at 6:10 a.m. on March 6, 1998. Surgery indicated on the consent form was for a resection abdominal aortic aneurysm (AAA repair). After Patient H.H. was taken to the operating room and administration of anesthesia began, Respondent performed his routine preoperative check of femoral and pedal pulses. Checking for femoral and pedal pulses is the type of preoperative work-up Respondent routinely performs while he waits for the anesthesia to take its effect on the patient. The operative report indicates that the abdominal aneurysm was "very large" extending quite high within 1-2 cm from the renal vein and down to and involving the common and hypogastric arteries and noted to be "quite saccular" with "impending rupture in the near future at the neck." The common iliacs were noted to be "quite large and aneurysmatic." The external iliacs were soft but extremely small, "approximately 4-5 mm in size, certainly less than half, more like 1/4 the size of a normal iliac" but nevertheless usable vessels to make his anastomosis. As Respondent was bluntly dissecting (separating the tissues using the fingers) the aortic aneurysm from the venous plexus to position his proximal clamp when one of the lumbar veins was encountered and mass bleeding occurred. The venous plexus is a grouping of veins located under the aorta that can best be described as a wagon wheel. The system has a hub and all the veins in the grouping extend outward from the hub. If one of the veins in the grouping is injured, it will bleed heavily, but the bleeding is controllable. The lumbar veins are part of the venous plexus and a tear of the lumbar vein is a known risk during this type of surgery. Patient H.H. suffered the loss of three times the amount of blood as would have been routinely expected. The sudden blood loss caused the patient's condition to rapidly deteriorate. Dr. Wickstrom-Hill, Anesthesiologist, testified that had Respondent not controlled the blood loss, and had not maintained Patient H.H.'s vital signs, she would have died. Using sound medical judgment, Respondent elected to bypass the aneurysmatic common iliacs and make his anastomosis of the graft to the external iliacs in order to not disconnect or separate the aortic or common iliac aneurysms from the iliac vein. This is a very fragile vessel and could have resulted in further massive bleeding and possible death of the patient. A reasonable prudent physician faced with a similar circumstance and situation would not attempt to mobilize the aneurysm further if doing so would cause additional massive blood loss and possible death of the patient. The hypogastric arteries (a/k/a the internal iliacs) serve to provide the pelvic viscera (bladder, rectum, etc.) with blood. During the AAA repair, Respondent performed an embolectomy on both legs following manipulation of the aneurysm. The purpose of this procedure was to remove any debris which may have dislodged from the aneurysm and flowed distally to the legs. The procedure involves running a Fogarty catheter down the femoral arteries as far as the catheter will go, then inflating a balloon located at the end of the catheter. Once the balloon is inflated, the surgeon will extract the catheter, pulling the debris out of the artery. This process is repeated as necessary to remove all debris. Fresh clot was obtained from both legs, indicating a lack of debris. Prior to completing the anastomosis of the bifurcated graft to the aorta and external iliacs respectively, Respondent ran a Fogarty catheter down proximal (back into the graft itself), to remove any debris in the graft itself. Finally, he back-bled the graft (allowed blood to flow out of the graft, to, again, ensure that there existed no debris in the graft). On March 7, 1998, Patient H.H.'s medical condition stabilized such that Respondent felt it safe to return Patient H.H. to the operating room to undergo an additional embolectomy of the legs and an endarterectomy of the right femoral artery. The record demonstrates that Respondent believed he collected embolic debris from the femoral arteries. However, based upon the pathology report and the testimony of Dr. Zeller, the debris removed from Patient H.H. during this procedure was acute blood clots and atherosclerotic plaque. This finding is consistent with thrombotic material and not a result of debris coming from another location as it tends to demonstrate that Patient H.H. had a clotting disorder consistent with her medical history. The record also demonstrates that upon completion of the procedure, Patient H.H. was noted to have excellent pulses in the superficial and profunda femoral arteries distal to the anastomosis with good emptying and filing of the vessels. Before, during, and after the AAA repair, Respondent used Heparin (an anti-clotting drug) in an effort to prevent the formation of clots throughout Patient H.H.'s vascular system. Intraoperatively, on March 3, 1998, Respondent administered 10,000 units of Heparin. Normally a patient will respond to 5,000 units. Despite giving Patient H.H. twice the normal amount of Heparin, Patient H.H. continued to have a lowered clotting time. It is noted in the medical record that Patient H.H. had an Antithrombin III deficiency. Antithrombin III is one of the factors that control how blood in the human body clots. Patient H.H.'s Antithrombin III deficiency is a hereditary defect that contributed significantly to her continued clotting despite the use of pharmacological intervention (substantial amount of Heparin). Respondent testified that in his medical training and experience, Patient H.H.'s Antithrombin III deficiency level was near fatal. Because Patient H.H. was hypercoagulative, thus causing the small vessels to clot off, on March 13, 1998, Patient H.H. underwent bilateral above the knee amputations. Hypercoagulopathy is a tendency to clot without anything being done - the blood just clots. This can be caused by a lower-than- normal blood pressure for a period of time and by having an Antithrombin III deficiency. Respondent observed during the surgery that this patient was hypercoagulative because he could see the blood clotting in the wound despite the fact that Patient H.H. was on twice the normal amount of Heparin. Respondent practiced within the standard of care at all times during the treatment of Patient H.H. Blood-flow going retrograde back into the common and iliac aneurismal sacs did not place Patient H.H. at a risk of rupture. The operative report clearly demonstrates that the aortic aneurysm involved the common iliacs and extended below the hypogastric arteries. The operative report also demonstrates that the external iliacs were extremely small, approximately one-quarter of the normal size. A reasonable and prudent surgeon, faced with a similarly situated patient with a massive sized aneurysm and the extremely small size of the distal external iliacs, would conclude that the pressure gradient now being carried to the graft rather than to the aneurysm would diminish flow to the aneurysms making the possibility of rupture unlikely. Moreover, the aneurysms were filled with calcified atherosclerotic plaque and other thrombotic (non-mobile) material. Dr. Begelman testified that calcified aneurysms do not tend to rupture as much. On direct examination, Dr. Begelman, Petitioner's expert, could not conclusively determine whether Respondent's surgical treatment of Patient H.H. fell below the standard of care and that distal clamping is an intra-operative decision to be made by the surgeon. Dr. Begelman who testified that he accepted Respondent's opinion that the iliacs were too large or too thin walled and could not distally clamp the aneurysm and that such decisions are those made by the surgeon on the case. Drs. Begelman and Seller and Respondent testified that it is usual and customary during this type of surgical procedure to distally clamp the aorta and that it is expected of a reasonable and prudent surgeon to make every attempt to do so. Nevertheless, all three doctors recognized that there are times when you cannot or should not distally clamp if to do so would cause further injury to the patient or death. Patient H.H. presented with very massive aneurysms of both the aorta and common iliacs making distal clamping impossible without sacrificing the hypogastric arteries thus placing Patient H.H. at risk for further injury or death. Petitioner's expert accepted Respondent's assessment of the condition of the iliacs and that Respondent did not want to dissect the iliacs off the iliac vein, which one needs to do in order to tie off distally. Dr. Begelman testified that he could not ascertain whether Respondent fell below the standard of care with respect to Respondent's treatment of Patient H.H. intraoperatively. Respondent acted within the standard of care and, therefore, did not violate Section 458.331(1)(t), Florida Statutes, when he did not clamp the distal arteries before manipulation of the aneurysm. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by sewing the bifurcated graft to the external iliacs and making no attempt to disconnect the aneurysm from the common and internal (a/k/a hypogastric) iliacs. The common and internal iliac tissues were also diseased because of their involvement with the aneurysms coupled with the fact that the aneurysm and surrounding tissue was inflamed. Inflammation causes the tissues of the surrounding viscera to become sticky and by that, stick together making separation difficult and more prone to bleeding on manipulation. Normally, the surgeon must bluntly dissect (lift up) the distal end of the aorta in order to place the distal clamps on the aorta below the aneurysm. However, the inflammation present in Patient H.H.'s aorta made it impossible to mobilize (lift up) the distal aorta for clamping because the tissue was stuck to the iliac vein which could have caused Patient H.H. to suffer a lethal blood loss. Normally, blood loss associated with this type of surgery amounts to 500 ccs for the total surgery. Patient H.H. lost 1500 ccs during the manipulation of the aortic aneurysm to place the proximal clamp and a total of 2400 ccs during the entire surgery which represented a blood loss of nearly 25-40 percent respectively of her estimated total blood volume. Respondent used sound medical judgment by making no attempt to dissect the common iliac from the subordinate tissue because, in his training and experience, the separation of tissues would have caused further, possible lethal bleeding. Drs. Begelman and Zeller, experts for Petitioner and Respondent respectively, testified that a reasonably prudent surgeon would not clamp below the common iliacs if to do so would sacrifice the hypogastric arteries and thereby cause irreparable harm or death to the patient. Dr. Zeller testified that the hypogastric arteries are of such importance that not clamping them, even at the risk of embolization, would nevertheless be within the standard of care. Respondent closely monitored Patient H.H. postoperatively. A reasonable and prudent surgeon is not expected to remain in the recovery room with his post-surgical patient until the patient becomes stable. Rather, the reasonable and prudent surgeon is expected to utilize the nursing staff who are charged with attending to the patient and to keep the physician updated on the patient's medical condition. Petitioner's witness, Doris Gutierrez, was the recovery room nurse on duty on March 6, 1998. Her duties included monitoring and reporting changes in Patient H.H.'s condition to Respondent. The record demonstrates that Respondent closely monitored Patient H.H. postoperatively by being in contact with the nursing staff and thereby giving orders for care and treatment to the nursing staff, either by telephone orders ("TO") or in person by verbal orders ("VO") to stabilize the patient. While in the recovery room, Patient H.H. was intubated, on a respirator. Petitioner's witnesses, Doris Gutierrez, confirmed Respondent's monitoring of Patient H.H. when she testified that she called Respondent several times to provide updates on Patient H.H.'s condition. The record demonstrates that postoperatively on March 6, 1998, Respondent wrote his initial order to the nursing staff at 12:30 p.m. while sitting in post-surgical recovery with Patient H.H. Thereafter, Respondent continued to monitor Patient H.H.'s condition and remained in communication with the nursing staff and wrote orders at 1:30 p.m., 2:30 p.m., 3:25 p.m., 5:00 p.m., 5:15 p.m., 8:15 p.m., and again on March 7, 1998 at 12:24 a.m. Following his TO on March 7, 1998, at 12:24 a.m., Respondent next saw Patient H.H. 7 1/2 hours later, at 8:00 a.m., prior to taking Patient H.H. to the surgery room to perform the endarterectomy and embolectomy. Ms. Gutierrez testified that she does not always note when the doctor comes back into the recovery room to give orders. She could not testify as to events that took place after Patient H.H. was transferred to the Surgical Intensive Care Unit ("SICU"). She also stated she did not know how many times Respondent went to SICU because she did not work in SICU when Patient H.H. was transferred out of the recovery room. Ms. Gutierrez was also unable to testify as to when the last time was that Respondent came to the recovery room. Respondent testified that there is a difference between a TO and a VO, the latter indicating that the physician was present in the room at the time he gave his order to the nurse. The evidence is not clear and convincing that Respondent did not provide appropriate postoperative monitoring of Patient H.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine: Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4406PL, and DOH Case No. 1994-12341. Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4407PL, and DOH Case No. 1999-57795. DONE AND ENTERED this 8th day of August, 2002, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of August, 2002. COPIES FURNISHED: William R. Huseman, Esquire Romualdo C. Marquinez, Esquire Huseman, Marquinez & Schlegal, P.A. 6320 St. Augustine Road, Building 12 Jacksonville, Florida 32217 Kim Kluck, Esquire Richard J. Shoop, Esquire Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issue in this case is whether Respondent committed certain disciplinary violations and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed dentist in the State of Florida, holding license number DN 0008830. He was granted a parenteral conscious sedation permit on February 27, 1988. Respondent has been licensed in the State of Florida since August 3, 1981. There is no evidence that he has been the subject of prior disciplinary proceedings. J. C. was born November 28, 1980. J.C. died August 17, 1989, at 7:10 p.m. due to anoxic encephalopathy, which is brain damage from lack of oxygen. Anoxic encephalopathy was due to complications of preparation for dental extractions. Two years prior to visiting Respondent, J. C. had been seen by another dentist, Alexander S. Nurrell. Complaining of a toothache, J. C., who was six years old, was seeing a dentist for the first time. The medical and dental history, which was provided by J. C.'s mother, revealed nothing material to this case. The mother noted that the child had never experienced an "unhappy" reaction of a dental or medical procedure. Following an examination, Dr. Nurrell determined that J. C. had been "neglected," at least in terms of her dental needs, which were considerable. Due to the scope of the work required by J. C., which involved repairs to 11 teeth, Dr. Nurrell intended to hospitalize J. C. in order to provide the necessary dental treatment. About one week after the visit to Dr. Nurrell, J.C.'s father took her to another dentist, Peter Weisbruch. Again, her complaint involved a toothache, which apparently had not been treated by Dr. Nurrell. Dr. Weisbruch commenced a dental treatment plan that J. C. followed for some time. Dr. Weisbruch administered a local anesthetic to J.C. on three occasions. On the first visit, Dr. Weisbruch administered an anesthetic, but failed to record the type or amount. On April 26, 1988, Dr. Weisbruch, while extracting one of J.C.'s teeth, administered 0.9 cc of 3% Carbocaine, which is a brand name of mepivicaine. On May 14, 1988, Dr. Weisbruch administered 0.9 cc of 2% lidocaine, as well as 0.9 cc of 1:100,000 epinephrine solution. On no occasion did J. C. exhibit an unusual reaction to any local anesthetic. She was, however, an uncooperative patient. On June 1, 1988, J. C.'s father informed Dr. Weisbruch's office that J. C.'s mother would be resuming responsibility for ensuring that J. C. received adequate dental care and that J. C. would not be returning to Dr. Weisbruch's office. Financial constraints limited the ability of J.C.'s parents to obtain dental services for their daughter. By June, 1989, however, her mother was prepared to recommence J.C.'s dental treatment. She looked for a dentist in the yellow pages based on physical proximity to their home. When she found Respondent's advertisement, she was impressed by its emphasis upon patient comfort, including such features as stereo headphones and anaesthesia. Aside from her dental problems, J. C.'s health at the time that she first saw Respondent was good. She had been seen periodically by a pediatrician for a well visit and then for a couple of common viral complaints. When she first contacted Respondent's office, J.C.'s mother told the receptionist that she needed to be able to pay for the dental work by periodic payments. The receptionist advised the mother to bring in J. C. for an initial consultation. J. C. and her mother first visited Respondent on June 29, 1989. The medical and dental history revealed nothing unusual except that J. C. had "extensive" dental complaints. Respondent took x-rays and fitted J. C. for a retainer on her first and second visits, with the latter taking place on July 5, 1989. J. C.'s mother paid $157 on July 10, leaving a balance of $125, which was to be paid over 90 days. As a result of his examination of J. C.'s teeth, Respondent advised J. C. and her mother that J. C. should have eight primary teeth removed. He apparently prescribed an antibiotic to treat a dental infection, but this treatment is irrelevant to the case. In any event, Respondent's office gave J. C. an appointment for August 9, 1989, for the extraction of the eight teeth. On August 8, Respondent's receptionist called J.C.'s mother and told her that Respondent had decided to put J.C. asleep during the extractions. Thus, he wanted an early morning appointment. They agreed to reschedule the appointment for August 16 at 8:30 a.m. J. C. was excited about going to the dentist. She intended to go out for the cheerleading squad once school started. She and her mother arrived at Respondent's office just before 8:30 a.m. J. C. sat on her mother's lap and was a little nervous, but they did not have to wait long. J. C. weighed 50- 55 pounds at this time. No later than 8:30 a.m., dental assistant Terri Neff came out to the waiting room and took J. C. and her mother into Operatory #2. Operatory ##2 and 3 are identical in terms of equipment and size. Respondent, who apparently was the only dentist practicing in his office, also used a third operatory, which is smaller and lacked a dental assistant chair. Ms. Neff was, at the time of the incident, a certified dental assistant. She had been for the preceding five years and had assisted in dental procedures and monitored patients in anaesthesia. She also held current certification in dental radiology, the administration of nitrous oxide, and cardiopulmonary resuscitation (CPR). As was the case with all of Respondent's employees, Ms. Neff had never attended the course entitled "Guidelines for Teaching Comprehensive Control of Pain and Anxiety." Just before J. C. was seated in the examination chair, Ms. Neff gave her a glass of water, which J. C. drank. As Ms. Neff explained to J.C.'s mother, the water contained five ml of Phenergan, which Respondent had prescribed to control the nausea occasionally experienced by patients from nitrous oxide. J. C. drank the Phenergan solution at 8:35 a.m. Phenergan, or promethazine, is an antiemetic used to control nausea in patients about to receive nitrous oxide. A central nervous system depressant, Phenergan is an antihistamine with a minor sedative effect. The drug manufacturer's literature, which is inserted into each box or carton of the drug, warns that the sedative action of Phenergan is "additive to the sedative effects of central nervous system depressants; therefore, agents such as . . . narcotic analgesics . . . should either be eliminated or given in reduced dosage in the presence of [Phenergan]." The drug insert advises that the dose of meperidine or Demerol be reduced by one-quarter to one-half. The drug insert also advises: [Phenergan] may lower seizure threshold. This should be taken into consideration when administering to persons with known seizure disorders or when in combination with narcotics or local anesthetics which may also affect seizure threshold. Five ml of Phenergan contains 6.25 mg of promethazine. Used in isolation, this dosage of Phenergan was appropriate and bordered on the low end of a safe and effective dosage. For preoperative medication, the recommended dose is 0.5 mg per pound in combination with an equal dose of meperidine and an "appropriate dose of an atroprinelike drug," according to the drug insert. In J. C.'s case, the recommended dose is thus 27.5 mg, and she received only about 23% of the recommended maximum dose of Phenergan. The same amount is the recommended dose when Phenergan is used in isolation to control nausea. Ms. Neff next placed a nasal mask over J. C.'s nose preparing to administer nitrous oxide. The mask was supposed to have a bubble gum smell, which is intended to please pediatric patients. When Ms. Neff asked J. C. if she could smell the bubble gum, the girl said she could not, so Ms. Neff replaced the mask with a strawberry-scented one. J. C. said she could smell this one, although her mother thought she might be humoring them. The nasal mask does not cover the mouth. It is made of rubber and is not heavy. The mask, which was a child's size, fit tightly on J. C.'s face. The nitrous oxide machine has settings for nitrous and oxygen. Each unit represents one liter of gas delivered per minute. Pursuant to Respondent's direction as to initial mix and time of commencement, Ms. Neff turned on the nitrous oxide machine shortly after placing the mask on J. C. The initial setting was 1:3 nitrous to oxygen. Nitrous oxide is a central nervous system depressant. J. C. was fidgety in the chair. After the mask was applied, she touched the mask frequently. She said that the mask felt funny and made her nose itch. She remained quite talkative. After the nitrous oxide had been administered to J. C. for about 30 minutes, Respondent entered the operatory to check on the girl. He waited awhile, noting that J. C. was still not calm enough to proceed. He then advised Ms. Neff that they would need to give J. C. an injection of Demerol. At about 9:02 a.m., Respondent gave J. C. an injection of 50 mg Demerol, or meperidine, in her right deltoid muscle. J. C. cried upon receiving the injection. Demerol is a narcotic analgesic similar in effect to morphine. Demerol is a central nervous system depressant. The drug insert warns prominently that "[Demerol] should be used with great caution and in reduced dosage in patients who are concurrently receiving . . . other CNS depressants . . .. Respiratory depression, hypotension, and profound sedation or coma may result." In isolation, the maximum dose is 0.8 mg per pound of body weight when the drug is used as premedication, which is how Respondent used the drug in this case, although the drug insert states that the "usual dosage" is 0.5 mg per pound when Demerol is used for preoperative medication. Using the rate of 0.8 mg per pound, the maximum dosage was 44 mg., if the Demerol had been used in isolation. No expert opined that the amount of Demerol administered to J. C. would have been excessive, if the drug had been used in isolation. However, when used, as here, in connection with one or more other central nervous system depressants, the dosage of Demerol was excessive, especially when combined with the administration of mepivicaine, as discussed below. J. C. cried when she received the injection. Respondent left the room, and J. C., evidently agitated, asked her mother, "is this how Grandma died?" Her mother tried to reassure her that everything was alright. After receiving the injection, J.C. began to rub around her eyes and face. This itchiness was due to a combination of one or more of the following: fidgetiness, continued resistance or possibly minor reaction to the mask, and a short-term release of histamines caused by the administration of the Demerol. However, the itchiness was not evidence of a serious allergic or anaphylactic reaction for reasons discussed below. Respondent's testimony that he noticed itchiness to an extent that he had not previously seen is discredited by, among other things, his failure to chart what would have been an unprecedented observation. At about the time of the Demerol injection, the nitrous oxide mix was changed, by Respondent's instructions, to 3:5. 1/ Ms. Neff remained with the mother and J. C. for about 30 minutes, waiting for J. C. to relax sufficiently so Respondent could proceed to administer the local anesthetic and begin the extractions. J. C. remained talkative during this period. While Ms. Neff was waiting with the mother and J.C. for the Demerol to take effect, someone told Ms. Neff that she was needed by another patient. Another assistant, Sarah Staley, joined J. C. and her mother at this time. At about this time, J. C. began to become more subdued. Aside from the receptionist, Ms. Staley was the least trained of Respondent's employees. First employed by Respondent about one year earlier, Ms. Staley had no prior dental experience. She had not undergone any formal training as a dental assistant or in CPR. Her position was best described as a business assistant/clerk. Ms. Staley was not trained to recognize any symptoms of a patient in sedation. At about 9:35 a.m., Respondent returned to Operatory #2. Finding J. C. sufficiently calm to proceed, Respondent began the process of administering mepivicaine. Mepivicaine, which is also a central nervous system depressant, is a local anesthetic. The drug insert warns: "Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration." The drug insert adds: If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent. Injection of repeated doses of mepivicaine may cause significant increases in blood levels with each repeated dosage due to slow accumulation of the drug or its metabolites, or due to slower metabolic degradation than normal. Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their weight and physical status. As to adverse reactions, the drug insert states: Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possible respiratory arrest. . . . Reactions involving the cardiovascular system include depression of the myocardium, hypotension, bradycardia, and even cardiac arrest. Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic. . . . As with other local anesthetics, anaphylactoid reactions to Mepivicaine have occurred rarely. The reaction may be abrupt and severe and is not usually dose related. The drug insert states that the "lowest dosage needed to provide effective anesthesia should be administered." The drug insert specifies the dosage as follows: "A dose of up to 3 mg per pound of body weight may be administered." Respondent injected mepivicaine into the area of the upper and lower jaws. Neither Ms. Staley nor the mother noted the number of cartridges of anesthetic that Respondent used. As the injections started, J. C. began to cry, and her mother held her hand to calm her. A cartridge, or carpule, is a glass tube containing medication in solution form. The cartridge in this case contained a 3% solution of mepivicaine. Each cartridge contained 1.8 cc of the medication or 54 mg. of mepivicaine. The cartridge is placed in the syringe, a negligible amount is expressed to eliminate any air bubbles and to ensure proper operation of the syringe, and then the remainder is available to be injected into the patient. The evidence is contradictory as to the amount of mepivicaine actually injected into J. C. There are two reasons for this. First, there is conflicting evidence as to the number of cartridges. Second, there is some evidence that less than an entire cartridge was injected each time. Although not arriving in the operatory until at least 10 minutes after the completion of the mepivicaine injections, dental assistant Kathleen Lyttle charted the entry, "mepivicaine 3%." Respondent later charted the remaining information concerning the number of cartridges of mepivicaine. Respondent first noted that he had used eight cartridges from 9:30 a.m. to 9:50 a.m. He made entries showing injections into the upper and lower left and right jaws. Although no number was placed next to each location, obviously a pair of injections in each of the four locations would result in eight cartridges. Respondent then made two interlineations. First, he wrote above the notes for the two upper-jaw entries the following notation: "x2," meaning that two cartridges each were injected in the upper left and right jaw for a total of six cartridges. The effect of this addition is to imply that only one was injected lower left and right jaw. Second, Respondent crossed out the number "8" and added, above the crossed-out "8," the notation, "5-6," meaning that a total of five to six cartridges were injected. In a conversation with the Orange County Medical Examiner shortly after the incident, Respondent stated that five to six cartridges were administered. Respondent told the medical examiner that he first completed the injections into the upper and lower left and right jaws, then injected a little more. In a written statement to the medical examiner, Respondent stated that six cartridges were administered. Petitioner has proved by clear and convincing evidence that Respondent administered to J. C. no less than six cartridges of mepivicaine. This number is consistent with the written statement that Respondent provided the medical examiner. This number is also consistent with the detailed itemization Respondent noted on the dental chart where he showed one injection each in the lower left and right jaw and then two injections each in the upper left and right jaw. The second issue is whether Respondent injected the entire contents of each cartridge. In his practice, Respondent often did not empty a cartridge of local anesthetic but instead left up to 20% of the contents uninjected. Petitioner has proved by clear and convincing evidence that Respondent injected the entire contents of the first four cartridges used in the upper right and left jaw, except for the negligible amount expressed for the reasons set forth above. Respondent had concluded that J. C. was an uncooperative patient. He had already chosen what he testified was the "upper limit" for the Demerol, which in fact was excessive in view of the prior administration of Phenergan. Respondent had also increased the nitrous oxide ratio to administer more nitrous. Most important, Respondent testified that, during his eight-year career, he had ignored maximum recommended dosages of local anesthetics. Nothing in the record suggests that, in the use of local anesthetics and central nervous system depressants, Respondent subscribed to the maxim, "Start low, go slow." Also, the consequences of the administration of the mepivicaine, which, as noted below, demonstrate local anesthetic toxicity rather than allergic reaction, are strong proof that Respondent administered a dosage of mepivicaine far in excess of the maximum recommended dosage. As to the final two cartridges, Petitioner has proved by clear and convincing evidence that Respondent did not withhold more than 20% of the contents of each cartridge. There is substantial evidence, as set forth in the preceding paragraph, that Respondent withheld less in this case. However, the results would be the same, based on the following findings. Respondent's testimony that he administered no more than about 200 mg of mepivicaine is discredited. This would represent the contents from 3.75 cartridges. By the time that Respondent spoke with the medical examiner, he had had more than enough time to reflect on the possibility that J. C. may have suffered a toxic reaction to a local anesthetic. Given that possibility, and the obvious ramifications that it held for Respondent, he certainly would have carefully reflected upon the actual amount of mepivicaine administered to J. C. It is inconceivable that if, instead of 5-6 cartridges, he determined that he had injected only 3.75 net cartridges, he would not have so informed the medical examiner at that time. It is more likely that the netting process, in order to reflect the unused contents of a cartridge, resulted in a reduction from eight to six cartridges. Based on the foregoing, the least amount of mepivicaine that Respondent actually injected into J. C. is four full cartridges into the upper and lower jaws followed by not less than four-fifths of a cartridge each injected into the upper right and left jaw. This yields a total of 5.6 cartridges or about 300 mg of mepivicaine. The finding of 5.6 cartridges or 300 mg of mepivicaine corresponds to Respondent's estimate of 5-6 cartridges. Petitioner has proved by clear and convincing evidence that Respondent's estimate is already reduced by at least the amount of medication that Respondent actually withheld. There is significant evidence, although not clear and convincing, that Respondent injected eight cartridges, which, assuming a 20% reduction even in each injection, means that he administered 6.4 cartridges or about 345 mg of mepivicaine. When used in isolation, mepivicaine is administered at the rate of not more than three mg per pound of body weight. 2/ In the case of J. C., the maximum recommended dosage would have been 165 mg of mepivicaine, if the drug had been used without any other medications. When used in connection with other central nervous system depressants or sedatives, like Phenergan, nitrous oxide, and Demerol, mepivicaine's maximum recommended dosage is not more than two mg per pound of body weight. In this case, then, the maximum recommended dosage for J. C. was 110 mg because the drug's effect would be potentiated by the other medications already given J. C. If J. C. had not been given other drugs, the dosage that she received was 1.8 times more than the recommended maximum dosage. Because she had already received other central nervous system depressants, the dosage that she received was 2.7 times the recommended maximum dosage. 3/ Respondent injected the mepivicaine from 9:35 a.m until about 9:52 a.m. He then left the operatory. As the mother and Ms. Staley watched over J. C., she said, "I love you, mommy." She then turned her head to the side and seemed to fall asleep, lying back in the chair. Respondent's testimony that, immediately following the injections, J. C. began to experience extremely bad itching around her eyes and face is discredited. If J. C. had experienced such a remarkable response, Respondent would have at least charted it, if not remained in the operatory until the phenomenon resolved itself. At best, Respondent has confused the onset of the itching, which in fact began with the application of the nitrous oxide mask. After Respondent left the operatory, the mother and Ms. Staley chatted about their preparations for the new schoolyear. Suddenly, at about 9:57 a.m., J. C. sat straight up in the chair with her eyes open unnaturally wide, trying to catch a breath, but unable to do so. After a few seconds, she slumped back into the chair and her arms and legs began shaking violently. After a few more seconds, her posturing and convulsions ended. Ms. Staley immediately summoned Respondent. Ms. Neff had by chance just been entering Operatory #2 at the moment that J. C. had sat upright in the chair. Ms. Neff immediately turned the nitrous oxide machine to 100% oxygen at its maximum setting of 10+ liters per minute. Ms. Neff testified that she was unaware that anything was wrong at this time and only thought that J. C. might need to go to the bathroom. Even after a few moments in the operatory, Ms. Neff continued to think that the they simply had "a nervous little girl in the chair." Another dental assistant, Lisa Ann Barlette, who was in the operatory across the hall, happened to see out of the corner of her eye J. C. when she had sat upright. Ms. Barlette had almost two years' experience as a dental assistant and was currently certified in CPR and dental radiology. Immediately excusing herself from her patient, Ms. Barlette started to walk across the hall into Operatory #2 and saw J. C.'s hands trying unsuccessfully to push the nitrous oxide mask up over her nose. Respondent entered the operatory immediately ahead of Ms. Barlette, who remained in the doorway. Respondent and Ms. Staley were telling J. C. to calm down. Upon entering Operatory #2, Respondent immediately tilted J. C.'s head back and chin up so as to establish an airway and eliminate any upper airway obstructions. He also began to take her pulse. Respondent noted that J. C. was in "severe respiratory distress." At about 10:03 a.m., J.C. had a second seizure in which she stiffened and then shook violently. She had a third seizure at about 10:04 a.m. and a fourth at about 10:05 a.m. She suffered a fifth seizure, of somewhat lesser intensity, at about 10:07 a.m. and a more intense seizure at about 10:09 a.m. During these seizures, J. C. gasped, as though sobbing, and continued to breathe as though she was trying to catch her breath. Between seizures, she responded to her mother with eye movements and by squeezing her hand. When told by her mother or Respondent to relax, J. C. responded by relaxing her grip. These were the limits of J. C.'s responses following the onset of the convulsions. At about 10:04 a.m., Respondent ordered that a rubber bite block be inserted to help control the upper airway during the seizures. After a few minutes following the first seizure, Ms. Staley began to suction mucous secretions from J. C. and continued to do so while J. C. remained in the chair. Entering Operatory #2 shortly after the clinical emergency began, Kathleen Lyttle, who later charted the mepivicaine, asked Respondent if he wanted her to take J.C.'s vital signs. Respondent nodded yes, and, because the blood pressure cuff in Operatory #2 was behind Ms. Staley and difficult to reach, Ms. Lyttle obtained one from another operatory. Ms. Lyttle was currently certified in dental radiology and CPR. She seemed to be the most experienced among Respondent's employees in handling a clinical emergency. Respondent administered at about 10:12 a.m. 4/ one cc of Narcan (0.4 mg/ml) by injection into the jaw. Narcan is a narcotic antagonist capable of counteracting the Demerol within seconds. At this time, J. C.'s respirations were beginning to decrease and she began to become cyanotic from a lack of oxygen. About a minute after injecting the Narcan, Respondent administered one ml of adrenalin chloride 1:1000 in the form of epinephrine solution by injection below the tongue. Attaching the blood pressure cuff on J.C.'s right thigh, Ms. Lyttle took her first reading of J. C.'s vital signs at about 10:13 a.m. J. C.'s blood pressure was 160/90, her pulse was 160, and her respiration was irregular. The vital signs were unchanged one minute later. By 10:15 a.m., the pulse and respiration were unchanged, but the blood pressure had dropped to 115/44. The interval between seizures was increasing, the seizures seemed to be lessening in intensity, and J.C. continued to respond between seizures in the manners described above. At about this point, Ms. Lyttle then turned to the mother and asked if J. C. had epilepsy. When told that she did not, Ms. Lyttle said, "Well, she's having an epileptic seizure." Since the first seizure, the mother had been standing in front of J. C. holding her arms or, as instructed by Ms. Lyttle shortly after she entered the operatory, massaging her daughter's chest. She could see her daughter's eyes moving wildly, then focusing as though on something in the distance that the rest of them could not see. Sometime after Ms. Lyttle had asked about epilepsy, which probably was after 10:15 a.m., the mother told Respondent to call the hospital, but no one responded. Ms. Barlette had earlier expressed the possibility of contacting emergency medical services. At about 10:00 a.m., Ms. Barlette caught Respondent's eyes and mouthed the words, "Do you want me to call?" She did not give voice to the words to avoid further alarming the mother. Staring at him, Ms. Barlette saw no response. It is not clear that Respondent comprehended what Ms. Barlette was trying to communicate. Within 30 seconds after her voiceless request, Ms. Barlette, noting that J. C. was turning red, caught Respondent's attention and asked audibly, "Do you want me to call 911?" About one minute later, or no later than 10:02 a.m., by which time J.C. had turned purple, Ms. Barlette repeated her request. Responding to neither request, Respondent evidently was so preoccupied that he either did not hear the requests or their meaning did not register with him. Despite the clear clinical emergency, the only vital sign taken was J. C.'s pulse until 10:13 a.m., when Ms. Lyttle first read J. C.'s vital signs. Surprisingly, the chronologies prepared by Respondent, the dental chart, and the testimony fail to disclose any meaningful activity during the period from 10:15 a.m. through 10:30 a.m. By the end of this 15-minute period, the seizures, which had evidently decreased in frequency and intensity, reintensified to the degree to which they resembled the early seizures. The next entry on the chart following 10:13 a.m. is 10:30 a.m., at which time J. C.'s vital signs are blood pressure 115/44, pulse 180, and respiration irregular. The notes add, "cardiac irreg[ular with] arrhythmia." Respondent's oral and written statements to the medical examiner add that J. C. was cyanotic or becoming cyanotic at this time. Five minutes later the vitals are 90/54, 200 and climbing, and irregular respiration. In the meantime, at about 10:34 a.m., Ms. Neff took the mother out of the room so she could make any telephone calls that she thought necessary, such as to alert J.C.'s father. The mother went into a nearby conference room for a few minutes, but was unable to make any calls because she could not remember anyone's telephone number. At 10:36 a.m., the chart notes for the first time "bronchial spasms [with] laryngeal spasms." The vitals are 60/44, 200 and climbing, and irregular respiration with tachycardia. The pulse is now thready and shallow. At 10:38 or 10:39 a.m., Ms. Lyttle stated that the blood pressure had "bottomed out." J. C. was in respiratory and cardiac arrest. Ms. Lyttle asked, "Call 911?" Respondent answered, "Go." Ms. Lyttle called 911 at about 10:41 or 10:42 a.m. and summarized the situation. Ms. Barlette later helped with the call. In the meantime, Respondent had taken J. C. from the chair and placed her on the floor where he could begin CPR. She vomited and aspirated the vomit and some mucous before Respondent cleared the vomit from her mouth and upper throat. Respondent began mouth-to-mouth and Ms. Lyttle, who had left Ms. Barlette with the phone, returned and immediately commenced compressing J. C.'s chest. As the mother was returning to Operatory #2, the mother heard Ms. Barlette on the telephone saying something about "Demerol." When she reentered the operatory, she saw that her daughter was now on the floor undergoing CPR. Although still without any pulse, J. C.'s color began to return to normal. The first ambulance arrived at 10:51 a.m. The paramedics found that J. C. was unconscious. Her lung sounds were clear, her pupils dilated, and her skin warm and dry. She still had no pulse, respiration, or blood pressure. Within a couple of minutes, the paramedics, after one failed attempt, successfully intubated J. C. and began ventilating her with an ambu bag that is attached to a portable oxygen cylinder. J. C. tried unsuccessfully to take a couple of breaths. After placing MAST pants on her to force the blood from her lower extremities, the paramedics quickly placed her on a rigid back board and transported her to Florida Hospital-- Altamonte Springs. From Florida Hospital--Altamonte Springs, J. C. was transferred by helicopter to Florida Hospital--South. However, she never regained consciousness and expired the evening of the following day. At 11:09 a.m., Respondent's office informed Florida Hospital-- Altamonte Springs of the medications given. In addition to noting aspects of the emergency treatment that J. C. received from the paramedics while still in Respondent's office, including being placed on oxygen under a positive pressure delivery system, the dental chart notes at the bottom: "1) anaphylactic response . . . to Demerol." Under this entry is "2) mepivicaine." The second entry is then crossed out. The internal examination of the autopsy revealed, as to the lungs, "moderate pulmonary congestion and edema . . .." As to the brain, there was "marked generalized brain swelling and softening." As for the brain-stem, cerebellum, and portion of the cerebrum, there was "severe generalized edema and softening." Upon microscopic examination, the autopsy reveals, as to the central nervous system, no evidence of chronic hypoxia, but "diffuse marked edema and hypoxic injury . . .." The lungs show "much pulmonary edema and congestion . . . with multifocal early bronchopneumonia . . .." The report continues: The changes in the lungs are consistent with acute bronchopneumonia, due to gastric aspiration, or due to reduced pulmonary toilet from being on a respirator with a greatly decreased mental status with or without gastric aspiration. Numerous factors compel the rejection of Respondent's theories that J. C. suffered an allergic, anaphylactic, or anaphylactoid reaction, perhaps in combination with an asthma attack. The evidence is clear and convincing that Respondent administered J. C. mepivicaine in excess of the maximum recommended dosage and, as a result of the overdose, J.C. suffered a toxic reaction to the local anesthetic. In dentistry, the overadministration of a drug, including a local anesthetic, accounts for about 85% of all adverse drug reactions. Drug allergies account for only about 15% of adverse drug reactions. Drug overdoses are even slightly more common in children than in adults. The central fact is that Respondent administered an overdose of mepivicaine to J. C. of 2.7 times the maximum recommended safe dosage. The patient's young age raised the possibility of higher blood levels per unit dose due to the greater likelihood that the functions of absorption, metabolism, and excretion in a child may be imperfectly developed. Another predisposing factor of which Respondent was aware was the stress and anxiety that J.C. has previously displayed. The local- anesthetic seizure threshold is reduced in such patients. The ensuing signs and symptoms are further evidence that J. C. died due to local anesthetic toxicity caused by the administration of an overdose of mepivicaine. The first effect of a toxic reaction to mepivicaine would be to depress the central nervous system. This effect manifested itself in J. C.'s case by the first objective signs: posturing and convulsions. Characteristic of toxic reactions to local anesthetics, such as mepivicaine, is a central nervous system excitatory phase. The reason for an excitatory phase is that the neurons in the central nervous system associated with excitation or stimulation are the last to be depressed by plasma levels of local anesthetics. Once unrestrained by the now-depressed inhibitory neurons, the electrical activity proceeds freely along the stimulatory pathways and stimulates muscle tissue, which may result in convulsions. The patient suffering an allergic reaction would not experience seizures until he had suffered hypoxia, which is an oxygen deficiency. At the time of J. C.'s initial seizures, which were due to the depression of aspects of the central nervous system, her breathing was still sufficient to preclude allergy-induced hypoxia. The depression of the central nervous system also affects respiration and blood pressure, as basic brain activities begin to decrease. During the early stages of the clinical emergency, J. C. continued to try to breathe. Contrary to Respondent's assertions, these efforts coupled with labored breathing were not evidence of an allergic reaction, but were entirely characteristic of central nervous system depression. The course of a toxic reaction to a local anesthetic proceeds to respiratory depression, where, as Respondent acknowledges, the desire to breathe is decreased. Then, the patient proceeds to respiratory arrest, followed by cardiac depression and cardiac arrest. This process is the result of reduced oxygen to the brain. The central nervous system depression initiates the reduction of oxygen to the brain. The seizures themselves exacerbate the problem. The convulsing brain requires increased oxygen to continue functioning. During the seizure, the patient breathes little, if at all. Once the brain activity has been impaired to the extent that respiratory depression begins, obviously the flow of oxygen is impaired even further, which further raises the likelihood of seizures. The flow of oxygen to the brain obviously ends completely with respiratory arrest. Within four to five minutes, the oxygen-deprived brain sustains irreversible damage. The evidence of allergy, including an anaphylactic reaction, is insubstantial. As noted above, Respondent administered an excessive amount of mepivicaine to J. C., and allergic reactions are very rare relative to drug overdoses. In addition, seizures and central nervous system excitement are not typically associated with allergic or anaphylactic reactions. Likewise, high blood pressure readings are uncharacteristic of allergic or anaphylactic reactions. The patient suffering an allergic reaction, such as an anaphylactic reaction, typically suffers only depressed blood pressure. The person suffering a toxic reaction to a local anesthetic experiences, as did J. C., first high blood pressure and then decreased blood pressure. Respondent asserts that several signs suggest the presence of an allergic or anaphylactic reaction. Itching is a classic sign of an allergic reaction. However, the itching in this case has been explained above. At most, J. C. may have experienced a minor reaction to the Demerol or a substance in the mask. The timing of J. C.'s subsequent symptoms is too delayed to be attributed as an allergic or anaphylactic reaction to the Demerol, nitrous oxide, or mask itself. Because the itchiness preexisted the administration of the mepivicaine, the local anesthetic could not have caused the itching. Another classic sign of an allergic reaction is a rash, but no rash was reported in this case. The tenacious mucous that Respondent reports did not appear initially. Such mucous is nonspecific and normally attends dental procedures, especially when the patient is a child under sedation. Moreover, when the body is undergoing a crisis of the type suffered by J.C., such mucosal secretions are normal. There is no reliable evidence of significant pulmonary edema, which is the accumulation of fluids within the air cells of the lungs, until at a stage of the clinical emergency at which the sign becomes quite nonspecific. Although associated with allergic reactions, pulmonary edema and congestion may also accompany local anesthetic toxicity, especially following the onset of respiratory depression. In any event, pulmonary edema and congestion are extremely common when persons die other than suddenly, as edema and congestion are associated with the failure of the respiratory and cardiovascular systems. The evidence of bronchial spasms and wheezing offered by Respondent is unpersuasive. Although normally associated with allergic or anaphylactic reactions, bronchial spasms and wheezing, to whatever extent they existed at all, do not appear to have been defining signs or symptoms of J. C.'s clinical emergency. A case report appearing in the November-December 1991 issue of the Journal of Dentistry for Children describes a case featuring many similarities with that of J. C. In the reported case, a five year old girl was being prepared for multiple extractions. After receiving five minutes of nitrous oxide at an unknown concentration, she then received five cartridges of 3% mepivicaine or 270 mg of the drug. Ten minutes later the girl experienced "'stiffening and shaking' of all extremities that lasted approximately ten seconds." She then underwent another convulsive episode, after which she was placed on 100% oxygen. After a third convulsive episode, the patient was still breathing on her own but was no longer responsive to verbal commands. Ten minutes after the first convulsion, she was transferred to a physician's office where she arrived in cardiac and respiratory arrest. Following CPR, the patient was given sodium bicarbonate, epinephrine, calcium gluconate, and atropine about 55 minutes after being given the local anesthetic. She was then transferred to a hospital where she was intubated due to lack of spontaneous respirations. Four days later, she was declared brain dead due to anoxic brain injury secondary to cardiopulmonary arrest following an overdose of mepivicaine. The article quotes "Malamed," who is the author of Respondent Exhibit 2, as advising that the maximum safe dose of mepivicaine is two mg per pound of body weight. 5/ The case report notes that higher blood levels of mepivicaine, resulting from more high overdoses, may result in convulsions due to an initial blockage of inhibitory neurons in the CNS, thus leaving the excitatory neurons firing unopposed. Still further increases in blood levels lead to unconsciousness and respiratory depression. The cardiovascular effects of a local anesthetic overdose include vasodilation, which in turn can lead to a drop in systemic blood pressure. There is also a direct depressant effect on the myocardial cell membrane, which can cause a progressive bradycardia and full cardiac arrest. Death can occur due to either respiratory depression or cardiac arrest. It is also important to realize the narcotic sedative regimens lower the convulsive threshold of local anesthetic and increase the likelihood of respiratory depression. The case report explains that average peak blood levels of 3% mepivicaine usually appear within 15-30 minutes following injection, and the plasma half-life is 90-120 minutes. The report concludes that, based on injection volumes, the maximum safe dosages are more rapidly reached with 3% mepivicaine than with 2% lidocaine plus epinephrin, which extends the effectiveness of the local anesthetic. In addition to confirming signs and symptoms described above, the article provides evidence that, in terms of the timing of signs and symptoms, J.C. suffered from a toxic reaction to an overdose of a local anesthetic. The first seizure took place 22 minutes after the first injection and five minutes after the last, which corresponds both to the timeframe for average peak blood levels and the 10-minute delay in the reported case. Not only did Respondent clearly fail to attain the minimum standards of performance in diagnosis and treatment when measured against prevailing peer performance (Standard of Care) in administering an overdose of mepivicaine to J. C., he then failed to attain the Standard of Care in equipping himself for detecting and managing such a clinical emergency and in the actual management of the crisis. The preparation of J. C. in this case is an example of the use parenteral conscious sedation. Parenteral conscious sedation, which alters a patient's awareness, does not render the patient unconscious or affect his active reflexes, such as a choking response. This type of sedation is defined further in the Conclusions of Law. First, Respondent's office lacked a pulse oximeter. This noninvasive device constantly measures the subject's pulse and oxygen saturation level in the peripheral blood. The failure to have and use a pulse oximeter while administering parenteral conscious sedation is in itself a failure to attain the Standard of Care. With such a device in J.C.'s case, Respondent probably would have been able to detect reduced oxygen levels, as a result of central nervous system depression, well in advance of the first convulsion. With proper treatment, Respondent possibly could have prevented the convulsions and averted the ensuing clinical emergency. Second, Respondent's office lacked a positive pressure oxygen delivery device. Unlike the pulse oximeter, which is a diagnostic device, the positive pressure oxygen device is used to treat certain patients who are suffering respiratory distress. The importance of this device is underscored by the fact that it is not unusual for a patient under parenteral conscious sedation to stop breathing or require breathing assistance. The dentist must then inflate the patient's lungs, typically using one of two devices: the demand valve mask or the breathing bag. The failure to have a positive pressure oxygen delivery system during the parenteral conscious sedation of a patient is in itself a failure to attain the Standard of Care. A dentist with ready access to a pulse oximeter and positive pressure oxygen delivery device should have been able to manage J. C.'s toxic reaction to the mepivicaine without the loss of life or even serious injury. Even without a pulse oximeter, a dentist should have been able to manage this clinical emergency without the loss of life or even serious injury. The proper management of the clinical emergency requires a thorough understanding of the process by which the body reacts to an overdose of a local anesthetic. Respondent tragically failed to apprehend the significance of the mepivicaine overdose that he had administered, evidently thinking instead that J. C. was exhibiting signs of an allergic or anaphylactic reaction, possibly to the mepivicaine. The Standard of Care requires that a dentist determine in the first five minutes following a convulsion if he is going to require emergency medical services and, if so, to summon such services at that time. The first thing the dentist must do after a patient suffers a convulsion is to establish an airway, which is a direct line from the patient's mouth to his lungs. If all that is required is to tilt the head back and chin up, as Respondent did, then such action is of course is sufficient. If, as here, such action is insufficient, the Standard of Care demands that a dentist using parenteral conscious sedation be prepared and able to insert an endotracheal tube or nasal airway in order to create a path for oxygen to reach the lungs. Responding to a question concerning Respondent's care in diagnosing and treating J. C. after the onset of convulsions, Respondent's expert, Dr. Wecht, conceded that Respondent failed to attain the Standard of Care: I think, with the time sequence here, given the circumstances, the panic, the anxiety, you know, were all understandable. I don't see anything dramatically negligent here in terms of wanton gross neglect, criminal negligence and so on. I just don't see it. Could this case be argued in the context of plain, unadorned negligence, could it be a bona fide malpractice case? Those are reasonable observations and inquiries, and I would be the first one to say that the answer to that could, indeed, be yes . . .. Respondent Exhibit 6, page 43. Respondent failed to manage the clinical emergency in a manner consistent with the Standard of Care. The evidence is overwhelming that he did not in fact maintain an effective airway. He was critically handicapped by the absence of a positive pressure oxygen delivery system. Switching the nitrous oxide machine to 100% oxygen did not help J. C., whose inspirations had become so impaired that she required ventilation. Had Respondent commenced CPR within the first few minutes of the onset of the convulsions, rather than about 45 minutes later, the brain injury might have been minimal. However, by the time Respondent commenced CPR, it was too late. By this time, ventilating the patient with 100% oxygen, as the paramedics did upon their arrival 12 minutes later, could do nothing for the severe brain damage that J. C. had already suffered. Respondent again failed to attain the Standard of Care by not summoning paramedics for about 45 minutes after the initial convulsion. Had he heeded the request of Ms. Barlette to call 911, there is a good chance that J. C. would not have died, notwithstanding Respondent's administration of an overdose of mepivicaine, absence of vital equipment, and evident inability to diagnose and treat the ensuing clinical emergency. Malamed, quoting Goodson and Moore, "Life Threatening Reactions after Pedontic Sedation: an Assessment of Narcotic, Local-Anesthetic, and Antiemetic Drug Interaction," in the Journal of American Dental Association, 107:239, 1983, states that the use of sedative techniques accompanied by the administration of narcotics requires continual monitoring of the cardiovascular and respiratory systems, ability of the practitioner to recognize and control the respiratory arrest and convulsions that are "easily induce[d]" by multiple sedative drug techniques, careful selection of dosages based on the body weight of the patient, and readiness to change the technique of sedation or choice of drugs at a later appointment rather than merely increasing the dosage when the initial dosage proves inadequate. Malamed reports that a recent three-year study attributed most deaths occurring in the dental practice related to the administration of drugs involved three factors: Improper preoperative evaluation of the patient. Lack of knowledge of drug pharmacology by the doctor. Lack of adequate monitoring during the procedure. Id. at p. 299. Malamed concludes: . . . with care on the part of the doctor, the incidence of [an overdose reaction to the administration of CNS-depressant drugs] should be extremely low, and a successful outcome should occur virtually every time. Id. On March 28, 1991, Respondent was indicted for the second degree felony of manslaughter in connection with the death of J. C. In a supplemental statement of particulars, the State of Florida alleged that Respondent administered an inappropriately high dosage of mepivicaine, Respondent's office was not equipped with a pulse oximeter or positive pressure oxygen delivery system, Respondent failed timely to contact emergency medical services, and Respondent thereby displayed a reckless disregard for human life. By plea agreement signed October 31, 1991, Respondent pleaded nolo contendere to the charge of manslaughter and waived his right to appeal any pretrial rulings. He was adjudicated guilty by judgment entered the same day and sentenced, pursuant to the agreement, to six months' community control followed by five years' supervised probation, together with various costs.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Board of Dentistry enter a final order revoking the license of Respondent. ENTERED this 24th day of February, 1992, in Tallahassee, Florida. ROBERT E. MEALE 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 24th day of February, 1992.
The Issue The issue for determination is whether Respondent, a licensed physician, committed violations of Chapter 458, Florida Statutes, sufficient to justify the imposition of disciplinarysanctions against her license. The resolution of this issue rests upon a determination of whether Respondent intubated the esophagus of a patient, as opposed to the patient's trachea, in the course of rendering anesthesia care; and whether Respondent then failed to provide a record justifying such a course of medical treatment.
Findings Of Fact Respondent is Saroja L. Ranpura, a licensed physician at all times pertinent to these proceedings, holding medical license number ME 0039872. Respondent was licensed in the State of Florida on April 27, 1982. She currently practices medicine in Ohio. Petitioner is the Department of Professional Regulation, Board of Medicine, the state agency charged with the regulation of physicians in the State of Florida. On August 29, 1985, Frank Snydle, M.D., performed a laparoscopy on patient C.P. at Heart of Florida Hospital in Haines City, Florida. This medical procedure was performed on an outpatient basis. As a result, C.P. came into the hospital on the day the surgery was to be performed. She met Respondent, who later provided anesthesia care to her in the course of the laparoscopy. Respondent examined C.P. at that time, prior to the surgery, and noted that C.P. had a small mouth. Later, C.P. was brought into the operating room on a stretcher and moved herself over onto the operating table. Present in the operating room at that time were Jean Allen, L.P.N., Norma Masters, R.N., and Respondent. Respondent proceeded to do an unusual procedure known as a "blind nasal intubation." The procedure requires the placement of an tube in the patient's throat through the nose, as opposed to the mouth, in order to maintain an open airway during later anesthesia administration in the process of surgery. C.P. was sedated, but awake, during this process and was intubated with a minor degree of difficulty. Prior to placement of the endotracheal tube, Respondent had the patient breath pure oxygen through a mask covering the mouth and nose. The preoxygenation process, according to Respondent, provided extra oxygen "as a reservoir and as astorage" to C.P.'s body tissues. By letting a patient breath 100 percent oxygen for three to four minutes, the resultant saturation permits a margin of four to six minutes for such an intubation to be safely completed without risk of the patient becoming hypoxic. Jean Allen, with almost 25 years of nursing experience in a surgical assistance career where she assists in 400 to 600 operations per year, observed Respondent during the entire intubation process, inclusive of the preoxygenation phase. Accepted medical practice after such an intubation requires that the person placing the tube then listen for breath sounds over each lung and over the area of the stomach. Respondent maintains that she did listen for those breath sounds with the aid of a stethoscope. The anesthesia record completed by Respondent has a notation "BEBS" for bilateral and equal breath sounds which Respondent testified that she heard with the stethoscope prior to administering additional sodium pentothal to the patient and inflating the cuff of the endotracheal tube. This testimony of Respondent is not credited in view of the testimony of Ms. Allen that she observed Respondent during this entire time and that Respondent did not listen for the breath sounds with a stethoscope prior to administering the additional sodium pentothal to the patient. Allen's testimony is also afforded the greater credibility due to her opportunity as a neutral witness to observe the events which transpired and her testimony that although she didn't observe Respondent closely after the additional sodium pentothal was administered, she maintained that she would have recalled Respondent's use of the stethoscope prior to that point. Notably, it is at that point prior to the administration of the additional sodium pentothal and inflation of the cuff of the endotracheal tube where Respondent maintains she listened for the breath sounds. Respondent, after completion of the placement of the endotracheal tube, administered additional sodium pentothal to the patient without listening for breath sounds; connected the tube to the anesthesia machine; and remarked that "it must be in place, the bag is moving" in reference to the bag on the anesthesia machine which generally inflates as the lungs of the patient deflate. While inflation or deflation of a breath bag on an anesthesia machine is one part of the procedure for checking placement of an endotracheal tube, the expert testimony of John Kruse, M.D., and David Alan Cross, M.D., establishes that this procedure alone is not a reliable method of determining proper tube placement. Frank Snydle, M.D., who had entered the operating room by this time in the sequence of events, did a manual vaginal examination of the patient, left the room, scrubbed his hands and returned. He then donned surgical gloves and gown, moved to the left side of the patient and prepared to proceed with the operation. Ms. Allen took her position at the foot of the table, between the patient's legs with an unobstructed view of Respondent. Dr. Snydle proceeded to make a small incision in the patient's abdomen through which he inserted a hollow, "Verres" needle. Carbon dioxide was then introduced to C.P.'s abdominalcavity to push the abdominal wall away from the internal organs. Next, a device known as a "trocar" and a "trocar sleeve" was inserted through the incision into the abdomen. The trocar was then withdrawn and a laparoscope was inserted into the sleeve. Built somewhat like a telescope with a built-in light source, the laparoscope permits the surgeon to look inside the abdomen and visually observe the patient's internal organs. During this procedure, Nurse Allen commented that she heard a sound like a fog horn or frogs croaking when she touched the patient's abdomen. Allen's remark is corroborated by Norma Masters and Dr. Snydle. The proof establishes, as corroborated by expert testimony of Dr. Kruse, that such sounds were associated with air, captured in C.P.'s stomach as the result of esophageal intubation, escaping from the stomach when pressure was applied. When Dr. Snydle made his first incision in the patient's abdomen, Allen observed that the blood was dark and Dr. Snydle agreed. Respondent inquired whether it could be venous blood. Snydle indicated he didn't think this was the case. Notably, the dark blood was observed, according to Respondent's medical records at 10:27 a.m. Further, Petitioner's experts, Dr. Kruse and Dr. Cross, based on their review of C.P.'s medical records, determined that the patient was initially intubated at approximately 10:15 a.m. Thus, approximately 12 minutes transpired from the beginning of the intubation process and conclusion of preoxygenation of the patient until the observation of dark bloodat the time of incision. After her inquiry regarding whether the blood could be venous, Respondent further responded that she was giving the patient 50 percent oxygen. She testified that she then increased the oxygen level to 100 percent. While the anesthesia record indicates administration of 100 percent oxygen, there is no time notation when this occurred. Blood again welled up from the incision and Nurse Allen commented that the blood appeared black. The less oxygenated blood becomes, the darker it appears. By this time, Dr. Snydle had inserted the laparoscope in C.P.'s abdomen. He observed that the internal organs were a "blueish color" ; an observation consistent with a decreasing level of oxygen in the patient's blood and an indication that the patient was hypoxic. When the patient's internal organs were discerned to be blue, Respondent asked Dr. Snydle to wait a moment and requested the assistance of Norma Masters, the circulating nurse. Masters came to the head of the operating table and was handed another endotracheal tube by Respondent. Respondent then began the process of intubating the patient with that tube through the mouth. The original nasal tube was left in place during the insertion of the second tube; an unheard of possibility, according to expert testimony, unless one tube was in the patient's esophagus and the other in the trachea. Nurse Allen's testimony establishes that the second tube, inserted via the patient's mouth, became foggy after insertion. The observation by Allen is consistent with experttestimony and establishes the fog was created by warm moist air from the patient's lungs flowing through the second tube. Respondent's testimony that she placed the second tube at the conclusion of the surgical procedure is not credited in view of the very clear, contradictory testimony of Masters and Allen that the endotracheal tube was replaced contemporaneously with the notation that the blood was dark and the patient's organs "blueish". After removal of the nasal tube and connection of the second tube to the anesthesia machine, Respondent manually squeezed the anesthesia bag to ventilate the patient. Dr. Snydle observed that the organs were turning pink again, and continued the procedure without further incident. After finishing the procedure, Snydle went out of the operating room, sat at a desk across the hall and began to write his orders. Following the procedure, the patient was wheeled to the recovery room, a short distance away. Nurses Allen and Masters did not see C.P. open her eyes during this process. Respondent's assertion that the patient opened her eyes and was responsive to commands is corroborated only by Dr. Snydle. However, while he noted in his operative report and his deposition that C.P. was awake following the operation, Snydle's observation is not credited in view of other proof establishing that his back was to the patient as she was wheeled past and that he assumed an awake state in the patient because Respondent was speaking to C.P. In view of the foregoing, Respondent's testimony that the patient was awake or responsive to commands following the surgery is not credited. After the patient was removed approximately 15 feet away to the recovery room, Respondent maintains that she informed Margaret Bloom, R.N., who was on duty there, that the patient's endotracheal tube was not to be removed, although she omitted telling Bloom about the dark blood incident. Bloom, who is also a certified registered nurse anesthetist, maintains that Respondent told her nothing about C.P.'s condition; instead, she went rapidly to the rest room in the lounge area. Bloom, left in the recovery room with the patient, then proceeded to hook up appropriate monitors and oxygen to the patient's endotracheal tube and began the process of monitoring C.P.'s vital signs. Bloom places the time of C.P.'s arrival time in the recovery room at approximately 11:05 a.m. The patient was not responsive to Bloom's spoken commands when brought to the recovery room. The patient appeared well oxygenated to Bloom; a judgement she made based on her observation of the color of C.P.'s lips and fingernails, since C.P. is a black female. Bloom rated C.P.'s circulation at twenty to fifty percent of preanesthetic pressure and determined the patient to be totally unconscious. Respondent returned to the recovery room at this time, told Bloom that she had done an "awake intubation" on the patient and that the tube should remain in place until Bloom determined that the patient was ready for it to be removed. Respondent then left the recovery room. As the result of blood tinged mucus filling the patient's endotracheal tube, Bloom removed the tube after thepatient registered breathing difficulties and attempts by Bloom to suction the mucus failed. She replaced that tube with a device known as an oral pharyngeal airway which goes in the patient's mouth and curves down the throat, holding the tongue forward. The device does not reach to the lungs. Shortly thereafter the patient began making glutteral noises and Bloom placed a venturi mask on the patient. The mask controlled the percentage of oxygen going to the patient, estimated by Bloom to be sixty to one hundred percent oxygen. The patient's breathing improved. Bloom completed replacement of the endotracheal tube with the airway device and mask shortly before Respondent again returned to the recovery room. Respondent, upset at Bloom's action in removing the endotracheal tube, proceeded to replace the oral airway device with a nasal tube. At 11:20 a.m., Bloom noted in her records that the patient's state of consciousness was unchanged. Later the patient made moaning sounds and was responsive to pain stimulation at approximately 12:20 p.m. Respondent concedes that C.P. suffered an hypoxic event at some point which resulted in damaged brain function. It is Respondent's position that such event occurred in the recovery room as the result of laryngospasm, occasioned by Bloom's removal of the endotracheal tube. Allen and Masters working in the operating room a short distance away testified that the sounds they heard emanating from the area of the recovery room were not the type of noise they associated with laryngospasm. Bloom, trained to recognize laryngospasm, testified that C.P. did not have sucha spasm. The expert testimony of David Cross, M.D., based on a study of arterial blood gases of C.P. following the surgery, establishes that the patient suffered an hypoxic episode too severe and too protracted to have been the result of a possible laryngospasm in the recovery room and that, in his expert opinion, she did not have a recovery room laryngospasm. Respondent's defense that C.P.'s survival of such a lengthy esophageal intubation in the operating room is an impossibility, is not persuasive. The opinion of Respondent's expert, Dr. Gilbert Stone, that no esophageal intubation occurred in the operating room is predicated on his belief that the tube was not changed during the surgery. Dr. Stone conceded that replacement of the tube during surgery at the time the dark blood was noticed with resultant improvement in the patient's condition permits a conclusion that esophageal intubation was the cause of the hypoxia. Testimony of Petitioner's experts, Dr. Cross and Dr. Kruse, are consistent in their conclusions that C.P. was esophageally intubated by Respondent, although they differ in their reasons for C.P.'s survival of the event. The opinion of these experts, coupled with the eye witness testimony of Allen and Masters, further support a finding of Respondent's esophageal intubation of the patient in the operating room and that she failed to recognize such intubation in a timely manner as a reasonable and prudent physician should have. The expert opinion testimony of Dr. Cross establishes that C.P. was intubated in her esophagus and survivedas a result of oxygen, going into her stomach under pressure, being forced back up her esophagus into the pharynx and then drawn by negative pressure into the lungs. This resulted in a effect similar to, but not as efficient as, the technique known as apneic oxygenation. The technique, once used to provide marginally adequate oxygen levels to maintain a patient's neurological and cardiac status, has fell into disfavor since patients suffered from respiratory acidosis due to the buildup of carbon dioxide in the lungs. Cross also pointed out that the heart can function for a much longer period of time without adequate oxygen than is possible for the brain. Cross's testimony provides an explanation for C.P.'s neurological damage without similar cardiac impairment. Cross also noted that the preoxygenation process which C.P. initially underwent after entering the operating room added to the time she was able to undergo oxygen deprivation before the onset of tissue damage. Respondent notes the discovery of a tumor in C.P.'s throat some months later as a possible contributor to the patient's hypoxic event during surgery. Another of Respondent's experts, Dr. Deane Briggs, an otolaryngologist specializing in diseases of the ears, nose and throat, treated C.P. in October of 1985, following the August, 1985 surgery. He discovered the existence of a sub-glottic tumor in the patient's throat. However, the existence of the tumor at the time of the initial surgery is not established. Testimony of anesthesiologist experts, including Respondent's own expert, Dr. Stone, do not support a finding that the tumor, if itexisted, had any effect during the operation. Further, Dr. Briggs' opinion that Respondent probably intubated the patient's right stem bronchus, as opposed to the esophagus, and that neurological damage therefore occurred in the recovery room is not credited in view of the conflict of this testimony with that of other witnesses and expert opinions. A finding that C.P.'s neurological impairment following surgery may have been exacerbated by a possible laryngospasm in the recovery room is relevant only with regard to mitigation of the severity of penalty to be imposed for Respondent's misconduct. Respondent's esophageal intubation of the patient in the operating room, and the resultant hypoxic event are established by clear and convincing evidence. The fact that C.P. suffered brain damage is undisputed by the parties. The proof clearly and convincingly establishes that the severe and protracted hypoxic episode sustained by the patient resulted not from a possible mild recovery room laryngospasm, but from Respondent's esophageal intubation of that patient in the operating room. It is concluded with respect to treatment of C.P., Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent failed to keep medical records which justified her course of treatment of the patient, C.P. This finding is based upon the testimony of Dr. Cross that Respondent'smedical records did not justify her course of treatment, as well as the testimony of Respondent's expert, Dr. Stone. While testifying that he did not believe Respondent had intubated the patient's esophagus, Stone also acknowledged that Respondent's records would be inadequate if such had indeed occurred.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered for Respondent's violation of Section 458.331(1)(t), Florida Statutes, placing Respondent's license on probation for a period of three years upon terms and conditions to be determined by the Board of Medicine, including, but not limited to, a condition requiring Respondent's participation in appropriate continuing medical education courses; and imposing an administrative fine of $2,000. IT IS FURTHER RECOMMENDED that such Final Order impose a penalty for Respondent's violation of Section 458.331(1)(m), Florida Statutes, of an administrative fine of $500 and a letter of reprimand. DONE AND ENTERED this 28th day of August, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS 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 28th day of August, 1989. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-28. Accepted. 29. Unnecessary to result. 30.-31. Accepted. 32.-34. Adopted by reference. 35.-61. Adopted in substance. 62. Unnecessary to result. 63.-68. Adopted in substance. 69.-87. Adopted by reference. Respondent's Proposed Findings. 1.-3. Rejected, not supported by the evidence. 4.-5. Rejected, not supported by the evidence, Further, proposed findings that records were adequate constitute legal conclusions. 6. Rejected, not supported by the evidence. COPIES FURNISHED: David G. Pius, Esq. Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Sidney L. Matthew, Esq. Suite 100 135 South Monroe St. Tallahassee, FL 32302 Kenneth Easley, Esq. General Counsel Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation The Northwood Centre 1940 N. Monroe St. Tallahassee, FL 32399-0750
The Issue The central issue in this case is whether proposed amendments to Rule 59G- 4.200, Florida Administrative Code, are invalid.
Findings Of Fact In 1993, the Florida legislature directed the Agency for Health Care Administration to implement a pressure ulcer therapy program for nursing home patients. The agency's legislative budget request for fiscal year 1993-94 sought funding for a pressure ulcer therapy program for eligible nursing home patients and estimated that 711 patients at a cost of $6,091,137 would utilize the program. A pressure ulcer is commonly known as a "bed sore." It is a loss in the integrity of the epidermis and is ranked, in stages, according to the severity of the sore. A stage I ulcer is a reddening or erythema of the skin. A stage II pressure ulcer includes an interruption of the epithelium in the surface lining of the skin. A stage III ulcer involves a deeper interruption of the epidermis, into the fatty layers of the skin. And a stage IV pressure ulcer extends to the bone or muscle, totally interrupting the surface of the skin. The rule which is the subject of this challenge, proposes reimbursable nursing home services for persons with stage III, stage IV, or multiple (three or more) stage II pressure ulcers. The nursing home facility must provide documentation that the resident meets the criteria established for the supplemental payment. The proposed rule provides that reimbursement is only available for the use of an "air fluidized therapy bed." An "air fluidized therapy bed" is defined by the proposed rule as "a support device that uses a high flow rate of air to fluidize a fine particulate material such as sand to produce a support medium that has characteristics very similar to a liquid." Generally, air fluidized therapy, also called "high air loss therapy," consists of a tublike chamber with a bottom surface and a blower that pushes air through ceramic or silicon beads. A top sheet covers the beads such that the patient, lying directly on the sheet, is supported by the floating beads. The beads circulate in a bath of warm air and maintain a very low support surface pressure against the patient. The therapy is described as "high air loss" because of the volume of warm air which escapes around the patient. Air fluidized therapy was originally developed to treat burn patients. The technology has proven beneficial with skin grafts or skin flaps. The Petitioner, Lumex, Inc., manufactures and markets various medical products including a "low air loss" therapy bed and mattress. The Petitioner, B & P Medical, Inc., is a medical equipment distributor based in Florida dealing with "low air loss" therapy beds. "Low air loss" therapy beds utilize a different technology from the air fluidized system described above. The system manufactured by Lumex and distributed by B & P is a bed or portable mattress with individual air cushions designed in zones. A true low air loss product should have a minimum of five zones. The Lumex 4000 consists of eighteen individual air cells and has six zones which are microprocessor controlled. The air pressure in each zone can be increased or decreased, depending on the patient's need. The billowing of the zonal pillows causes the reduced surface pressure to the patient. Generally, this pressure is "below capillary closing." Both low air loss and air fluidized systems are used in the treatment of pressure ulcers. Since approximately 31 percent of all nursing home patients suffer from some degree of pressure ulcer formation, effective treatments are needed. Among additional treatment options are: turning the patient regularly; providing adequate nutrition; dressing wounds properly; and keeping the wound bed clean. Although both technologies are used, the low air loss system is used more in Florida. The low air loss system is lighter in weight than the air fluidized systems, and requires no additional nursing home staff to implement for a patient. An air fluidized system requires additional staff as patients are lowered into and raised out of the mechanism. The costs associated with such staff may result in higher daily rates. As a result, such daily rates may be higher than necessary if the low air loss services were otherwise reimbursable. Additionally, the rates for reimbursement of the air fluidized systems are higher than for the low air loss system. To date, there is no definitive study to verify which treatment system will render better care to a pressure ulcer patient. In fact, some patients do not improve despite the treatment provided as even the best therapies used may not heal all pressure ulcers. Aetna, the largest intermediary in the United States for Part A reimbursement under the Medicare Program, has defined "low air loss therapy" to be reimbursable under Part A. Pursuant to such definition, the Lumex product at issue in this proceeding is reimbursable under Part A. Additionally, two states have accepted the Lumex Akrotech 4000 for reimbursement under Medicaid. Medicare does not pay for the use of air fluidized systems in nursing homes. The proposed rule would eliminate Lumex from the Florida Medicaid market. As a result, B & P would expect to lose approximately one-third of its business, a substantial portion of its revenue.
Findings Of Fact In August 1983 Deborah K. Grove, Respondent, was employed by Polk General Hospital as a registered nurse. On August 21, 1983, Respondent was the charge nurse in the nursery at Polk General Hospital. During the mid-morning of August 21, Polk General received a report that a premature baby had been born in the women's toilet at the jail in Bartow and mother and child were enroute to the hospital by emergency vehicle. Preliminary report was that the infant was having difficulty breathing, was somewhat cyanotic, but had a good pulse. This information was passed to the nursery to enable them to prepare to receive this infant. Respondent telephoned the duty pediatrician, Dr. Pilapil, who was in charge of the pediatric section that day to inform him of the pending arrival and to get instructions. For a baby born outside the hospital the general practice is to place the baby in isolation to guard against infecting other babies in the nursery. Dr. Pilapil told Respondent to place the baby in an incubator in isolation and that he would come to the nursery shortly. At the time this call was received Dr. Pilapil was standing by in surgery to receive a baby to be delivered by Caesarean section. At this time that patient had not been anesthesized. Dr. Rahn Shaw was a resident at Polk General Hospital in Family Practice Residency Program and was assigned to pediatrics. Shaw had graduated from medical school some two months before and had been at Polk General for approximately two weeks on August 21, 1983, when he was advised of the expected arrival. Shaw was described by other doctors as a very good resident, but he had never before faced a crisis situation unsupervised. In the meantime Respondent had directed the incubator be connected to heat and oxygen and prepared for the baby's arrival. Upon receipt of the initial report Respondent believed the baby would be dead on arrival or expire shortly thereafter. Some ten minutes later the ambulance arrived with the mother and child. When wheeled in the hospital the baby was lying on its mother's abdomen and the umbilical cord had not been cut. Dr. Shaw severed the umbilical cord and proceeded toward the nursery with the baby. At this time the baby was gasping for breath, was cyanotic but had a strong heart beat. Shaw was led to the isolation section by Respondent who took the infant from Shaw, put her in the incubator and closed the top of the incubator. There was a great amount of dispute at this point in time regarding the infant's continued need for suction. The paramedics who accompanied the infant in the ambulance had suctioned the baby's mouth and nose and had given the infant oxygen enroute to the hospital. Upon arrival of the infant at the hospital, after the cord had been severed, Shaw was given an OB pack which contained a suction bulb he used to suction the infant. Before the infant arrived at the incubator the suction bulb had been dropped on the floor and was no longer available for use. Shaw testified the baby needed continued suction, the paramedics testified additional suctioning was not needed when they arrived at the hospital, and other witnesses testified on both sides of this issue. The most accurate condition is believed to be that additional suctioning was indicated but was not essential. Partly as a result of a provision in Polk General Hospital's policy manual regarding premature infants (Exhibit 2), several nurses were under the distinct impression that only pediatricians could give orders in the nursery. Since residents could practice only under the supervision of a licensed doctor, the authority of a resident to give orders in the nursery was even more suspect. When news of the imminent arrival of the baby born in the jail toilet was announced, and Shaw was the doctor in charge, Respondent told another nurse that she would not take orders from Shaw. Enroute to the pediatric isolation section with the infant in his hands, Shaw attempted to help the infant's breathing by holding its head down slightly to help remove mucus and to resuscitate the infant by pressing on the rib cage. When he handed the infant to Respondent, saw the infant placed in the incubator with no further attempt to help the baby deemed to be in critical condition, Shaw opened the incubator and recommenced resuscitation. When he felt what he thought to be a slowing of the heartbeat, he started chest massage to increase the heartbeat. At this time Shaw was a very concerned and frightened young doctor who wasn't getting the help he expected and needed from the Respondent. Respondent was disturbed that Shaw was interfering with her duties to care for the infant as she had been directed by Dr. Pilapil. Respondent believed the infant would be all right if left in the warm incubator with adequate oxygen and that chest massage was not necessary or indicated on such a small baby. She also feared that Dr. Shaw would attempt to intubate the infant and she did not believe he had sufficient experience to do so on a premature infant. Shaw, on the other hand, believed the infant would die if left to its own resources in the incubator. All witnesses agree that the choice of an incubator in which to place the infant was a poor one and that the infant could have been better cared for had an isolette been used. The latter would allow the infant to be handled through the ports of the side of the isolette and not disturb the warmth and oxygen supply to the infant which results when the incubator is used and the top is lifted to work on the infant. Shortly after Shaw removed the infant from the incubator he asked Respondent what the gestational age of the infant was. Respondent didn't know, but, to provide information needed for future procedures, placed the baby on the scales and recorded a weight of 1 lb. 14 ozs. This procedure should have been delayed until the infant had passed the critical phase. After Shaw commenced working the infant in the incubator Respondent again telephone Dr. Pilapil, who advised her he would be there shortly. Again there was conflicting testimony as to events immediately following. Shaw testified he was left alone with the infant for ten minutes, that he became so concerned and frustrated that he began to cry; that his request to Respondent for help was rebuffed, and that when she did return he told her "If you're not going to help me, get the hell out of the room." Shaw also thought of intubating the infant. Respondent testified that when she left the isolation room to get supplies or call Dr. Pilapil she always ensured someone else was present with Shaw, that she complied with all of Shaw's orders to get necessary equipment, that she provided a bubble blanket, ambu bag and oxyhood for the baby, and that Shaw had worked on the baby for ten minutes before she realized that he was not going to let her do her job. Other witnesses affirmed that Shaw was crying and that he was left alone only for a very brief period, if at all. When the baby was first taken to the isolation section and the top of the incubator was lifted by Shaw, he and Respondent started arguing about the proper care for the infant. Respondent testified that she didn't need orders to provide oxygen and warmth to the infant and that she did provide both. She also told Shaw that she would not obey his orders. At the hearing Respondent testified that she did obey the orders she received from Shaw relating to getting equipment for the infant. Nursing procedures require nurses to follow doctors' orders. If the order is patently erroneous, or if the nurse believes the order to be wrong, it is appropriate for the nurse to delay carrying out the order while a supervisor is called to the scene. The evidence was unrebutted that orders given by a doctor not on the scene may be modified by the nurse when a crisis situation, not anticipated by the off-scene doctor, arises. Pursuant to this principle, when the infant arrived in a crisis condition the infant should have been placed in that part of the nursery providing all the equipment needed rather than in an incubator in isolation. Had an isolette been taken to the isolation section, better care could have been provided for the infant, or the infant could have been placed in an isolette in the observation part of the nursery. On the other hand, isolettes are in a limited supply and, if the infant had died in the isolette (as Respondent apparently thought might happen), the isolette would have to be "sunned" which consists of placing the isolette in the "sun" for three days after cleaning it before it is again used. When Dr. Pilapil finally arrived and relieved Shaw, he had the infant placed in an isolette. The infant survived without apparent further difficulty. It is evident that had Dr. Pilapil been at the nursery when the premature infant arrived the events leading to the charges here being considered would not have occurred. When the infant did arrive Respondent accurately relayed the infant's symptoms to Dr. Pilapil. Had he come to the nursery then, this hearing would not have been necessary. Shaw reported the incident to Dr. Caltenco, an obstetrician on the staff at Polk General, who told Shaw to write down the events as he recalled them. Caltenco advised the hospital authorities of the incident. Respondent called Juanita Lott, R.N., assistant director of nursing at Polk General, at her home to tell her of the incident and that she (Respondent) might be in trouble, but did not advise Frances Bass, R.N., the head nurse at obstetrics at Polk General, who was Respondent's supervisor on duty at the time the incident occurred. Ms. Bass learned of the incident while on duty that day and called the Director of Nursing, Laurie McCranie. Ms. McCranie told Ms. Bass to submit what she knew in writing, have Respondent do the same thing and present these statements to her when she arrived at the hospital on Monday. At a meeting among Respondent, Ms. McCranie, and others involved in the incident of August 21, 1983, Respondent admitted to Ms. McCranie that she had told Shaw she would not follow his orders and that she would not follow the orders of anyone in the pediatrics ward who was not a pediatrician. When Respondent persisted in her position that she had done nothing wrong and would do the same thing again in similar circumstances, despite being warned that such persistence would result in her discharge from employment at Polk General Hospital, Respondent's employment was terminated. Respondent is an excellent clinical nurse, well versed in nursing practices and procedure and was considered to be an excellent member of Polk General Hospital's nursing staff before the August 21, 1983, incident. In her exit evaluation (Exhibit 6) Respondent received the highest mark on the form (Excellent) but for block 5 -- ability to get along with others -- in which she was marked "good."
