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
The Issue The issue to determine in this matter is whether Ashton Payne suffered a "birth-related neurological injury" as defined by section 766.302(2), Florida Statutes, for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Ashton was born on January 19, 2018. Ashton was delivered at Winter Park Hospital. Petitioner Michele Mark is Ashton's mother. Petitioners are Ashton's natural parents and legal guardians. Michele M. Cabrera, M.D., delivered Ashton at Winter Park Hospital. Dr. Cabrera was a "participating physician" in the Plan at the time she rendered obstetrical services on January 19, 2018. See § 766.302, Fla. Stat. Dr. Cabrera provided her obstetrical services in the course of Ashton's delivery, and the resuscitation in the immediate post-delivery period. Ashton weighed 3310 grams at birth. The parties do not dispute that Ashton has suffered an injury to his brain due to oxygen deprivation which has left him permanently and substantially mentally and physically impaired. The parties do not dispute that the NICA notice requirements, as set forth in section 766.316, were met. Ashton was born under very challenging circumstances. At approximately 1:11 a.m. on January 19, 2018, Ms. Mark appeared at Winnie Palmer.3/ Ms. Mark, who was at 37 weeks' gestation, complained of contractions and severe pain. At Winnie Palmer, a triage nurse evaluated Ms. Mark. The examination revealed that Ms. Mark was experiencing intermittent contractions. The nurse also recorded that Ms. Mark's cervix was one centimeter dilated and 100 percent effaced. Ms. Mark informed the nursing staff that an ultrasound two days earlier revealed that the fetus was breech. However, apparently because the birth was not imminent, Ms. Mark was discharged from Winnie Palmer at 2:33 a.m. Back at her home, at approximately 3:19 a.m., Ms. Mark experienced a spontaneous rupture of her fetal membranes (her "water broke"). The rupture immediate resulted in an umbilical cord prolapse. A cord prolapse means that the umbilical cord dropped down through the cervix before the baby. This complication can cause the umbilical cord to be occluded, or squeezed, which can severely diminish the flow of oxygen to the fetus. Later, Ms. Mark relayed that she felt her baby's foot in her vagina (a "footling" breech). Sitting on her bathroom floor, with the umbilical cord protruding from the birth canal, Ms. Mark called 911. At 3:30 a.m., Emergency Medical Service personnel ("EMS") responded to Ms. Mark's home. When EMS reached Ms. Mark, they found her seated with approximately 15 inches of umbilical cord exposed. Initially, EMS was unable to feel a pulse in the umbilical cord. Once Ms. Mark was lifted and repositioned onto a stretcher, however, EMS was able to detect a faint pulse in the cord. EMS also noted that Ms. Mark was experiencing contractions "2 minutes apart." EMS transported Ms. Mark, in an ambulance, to Winter Park Hospital. EMS departed Ms. Mark's home at 3:41 a.m., and arrived at Winter Park Hospital at 3:53 a.m. At 3:58 a.m., Ms. Mark reached the Labor and Delivery Operating Room. There, she underwent an emergency C-section. Prior to the operation, the triage nurse palpated pulsation in the prolapsed cord. Ms. Mark was still experiencing contractions at two to three minutes apart. Dr. Cabrera conducted the emergency C-section. Ashton was delivered at 4:04 a.m. Dr. Cabrera's notes record "fetal distress cord prolapse, fetal malposition footling breech." A "footling breech" indicates that one or both of the baby's feet were positioned in the birth canal instead of the pelvis. Upon Ashton's delivery, Winter Park Hospital initiated a "Code Blue." Dr. Cabrera immediately started emergency resuscitative measures. At delivery, Ashton was not breathing, with a recorded heart rate of only 30 beats per minute. Ashton required full cardiorespiratory resuscitation. Ashton was emergently intubated at 4:06 a.m. Chest compressions were initiated "@ 20-30 seconds of life" and stopped at 4:08 a.m. At 4:08 a.m., Ashton's heart rate had reached 104 beats per minute. The Code Blue lasted from 4:04 a.m. to 4:29 a.m. By 4:29 a.m., Ashton's heart rate had risen to 144 beats per minute. The last oxygen saturation level recorded during the Code Blue was 77 percent at 4:19 a.m., indicating severe hypoxia. ("Hypoxia" means partial loss of oxygen to the fetus. "Anoxia" means total loss of oxygen to the fetus. The normal oxygen saturation range is 97-100 percent.) Ashton's APGAR ("Appearance, Pulse, Grimace, Activity, Respiration") scores following delivery were 1/2/4/4 at 1, 5, 10, and 15 minutes, respectively. (Scores of 7 to 10 are considered normal.) At 4:29 a.m., Ashton was transferred to the Neonatal Intensive Care Unit ("NICU"). Ashton was still unable to breath on his own. NICU noted "no respiratory effort and seizures." NICU placed Ashton on a mechanical ventilator in a continued effort to resuscitate him. At 4:41 a.m., the initial Arterial Blood Gas ("ABG") Report showed that Ashton was experiencing severe metabolic acidosis. The ABG Report recorded a pH level of 6.809 (critical) with a base excess of negative 25. This score signified a severely acidotic child with both a metabolic and respiratory acidotic condition. The acidotic condition required immediate medical treatment to correct. At 5:14 a.m., approximately 70 minutes after Ashton's birth, a second ABG Report showed a pH level of 7.034 (critical) with a base excess of negative 19. These values indicated that Ashton was continuing to experience severe metabolic acidosis. At 7:15 a.m., Ashton was transferred to the NICU at Florida Hospital Orlando. Although Ashton's oxygen saturation level had reached 99 percent, he was still unable to breathe on his own. He remained on a ventilator. Ashton also experienced repeated seizure activity. A progress report on January 21, 2018 (two days after his delivery), noted two episodes of seizures on that day. Ashton remained on a ventilator until January 26, 2018 (seven days after his delivery), when he was extubated. Petitioners argue that Ashton did not suffer a "birth- related neurological injury" which would entitle him to an award under the Plan. Section 766.302(2) defines the term to mean: njury to the brain or spinal cord of a live infant weighing at least 2,500 grams for a single gestation . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired. Petitioners do not dispute that Ashton's case presents an injury to the brain of a live infant weighing at least 2,500 grams. Neither do Petitioners contest that Ashton's injury was caused by oxygen deprivation which renders him permanently and substantially mentally and physically impaired. What Petitioners challenge is whether Ashton's injury occurred "in the course of labor, delivery, or resuscitation in the immediate postdelivery period." Petitioners assert that Ashton's neurological impairment directly resulted from the umbilical cord prolapse in Ms. Mark's home at 3:19 a.m. Petitioners contend that Ashton's brain injury (due to oxygen deprivation) manifested before the time Ms. Mark reached Winter Park Hospital (3:53 a.m.). Consequently, Ashton's injury did not develop during his delivery at 4:04 a.m. or any subsequent postdelivery resuscitation efforts. Petitioners further argue that Ms. Mark was never in labor at any point during Ashton's birth. Therefore, they contend that Ashton's brain injury did not occur "in the course of labor, delivery, or resuscitation," and Ashton does not qualify for coverage under the Plan. To support their argument, at the final hearing, Petitioners presented the (deposition) testimony of Jason James, M.D., and Ariel Sherbany, M.D. Dr. James is a board-certified obstetrician/ gynecologist. Dr. James testified that, in his opinion, Ashton did not sustain a qualifying "birth-related" injury because Ms. Mark was not in labor at any point prior to Ashton's delivery at 4:04 a.m. Initially, Dr. James commented that it is "impossible to say" with any certainty whether Ms. Mark was in labor at the time of the umbilical cord prolapse at her home or prior to Ashton's delivery. Dr. James defined labor as "progressive cervical change in response to contractions." He relayed that, "In order for me to say a patient's in labor, I would need to see progressive cervical change in the presence of contractions, and we don't see that." Dr. James explained that, even with Ms. Mark dilated at one centimeter at Winnie Palmer, he saw "no documentation of any cervical change, whether by the EMS or by the hospital staff at Winter Park." Dr. James further expounded that the 100 percent effacement observed at Winnie Palmer was not necessarily related to labor. "Effacement is one of the cervical changes that we do see, but there are things that can cause cervical effacement that are not associated with labor." Accordingly, Dr. James did not see sufficient evidence to conclude that Ms. Mark was in labor before Ashton's delivery. Regarding the exact time Ashton's brain injury occurred, Dr. James testified that Ashton's brain injury resulted from oxygen deprivation due to the umbilical cord prolapse. He opined that the majority of the oxygen deprivation occurred during the 34 minutes from the "moments . . . the cord prolapse occurred" (3:19 a.m.) to the time Ms. Mark arrived at Winter Park Hospital (3:53 a.m.). Dr. James stated that: [T]he amount of brain damage that occurred prior to even the patient arriving at the hospital was substantial and permanent, and I think that the die was cast. . . . Was there ongoing and further damage? Yes. I will agree that there was ongoing and further damage, but I think that to say that that was the portion that resulted in permanent impairment is a mischaracterization. Accordingly, Dr. James supported Petitioners' position that Ashton's brain injury did not occur in the course of labor, delivery, or resuscitation in the immediate postdelivery period because "this baby already had substantial and permanent brain damage on arrival." Despite this assertion, Dr. James conceded that Ashton did suffer oxygen deprivation during the 11 minutes between the time Ms. Mark was admitted to Winter Park Hospital (3:53 a.m.) and his delivery at 4:04 a.m. Dr. James also accepted that Ashton continued to incur brain damage through the one hour and 10-minute time frame after his birth.4/ Dr. James further acknowledged that the hypoxia (partial lack of oxygen) Ashton experienced after 3:53 a.m. could have resulted in significant brain impairment. Finally, Dr. James disclosed that, in his opinion, Ashton was never anoxic (total lack of oxygen to the fetus) during the 34 minutes prior to Ms. Mark's arrival at Winter Park Hospital. Dr. Sherbany is a pediatric neurologist. Dr. Sherbany offered no opinion as to whether Ms. Mark was actually in labor at the time of the umbilical cord prolapse. Regarding the time period during which Ashton's brain injury due to oxygen deprivation occurred, Dr. Sherbany testified that Ashton's "brain-damaged fate was already predetermined before he arrived." Dr. Sherbany believed that the umbilical cord prolapse caused anoxia, or complete loss of oxygen to the fetus. Dr. Sherbany opined that this period of anoxia lasted 11 minutes until EMS repositioned Ms. Mark on a stretcher. Thereafter, the fetus experienced hypoxia (partial loss of oxygen) until Ms. Mark was admitted to the hospital. Dr. Sherbany explained that the "bulk of [Ashton's] oxygen deprivation really occurred" during the 34-minute time period before Ms. Mark presented at Winter Park Hospital. Dr. Sherbany expressed that, "The damage was determined at the time of that anoxic event. . . . In those 34 minutes, basically, this unfortunate child suffered his fate." In Dr. Sherbany's opinion, Ashton sustained the "majority of the insult to the brain stem . . . during that anoxic period." Like Dr. James, however, Dr. Sherbany conceded that Ashton continued to suffer oxygen deprivation, which resulted in additional brain injury, in the first 11 minutes after Ms. Mark arrived at Winter Park Hospital up to and through the four minutes of cardiac massage administered to Ashton after his delivery. Although Dr. Sherbany limited the immediate postdelivery resuscitation period to four minutes after birth, he acknowledged that Ashton was not medically stable until he was transported to the NICU unit at Florida Hospital Orlando at 7:15 a.m., three hours and 11 minutes after delivery. Dr. Sherbany also recognized that Ashton did not breathe on his own, without the assistance of a mechanical ventilator, for six days after his birth. Upon receiving Petitioners' Petition for NICA benefits, NICA conducted an evaluation to determine whether Petitioners' claim was compensable under the Plan. Unlike Petitioners, however, NICA concluded that Ashton did suffer a "birth-related neurological injury" within the meaning of section 766.302(2) and should be covered by the Plan. NICA does not dispute Petitioners' claim that Ashton suffered oxygen deprivation beginning as early as 3:19 a.m. (the moment of the umbilical cord prolapse) through 3:53 a.m. (All medical experts agree that Ashton experienced oxygen deprivation, as well as brain injury, between 3:19 a.m. and 3:53 a.m.) However, NICA asserts that Ms. Mark was in labor at the time of the cord prolapse. NICA also argues that Ashton continued to experience oxygen deprivation (which resulted in brain injury) through his delivery and postdelivery resuscitation at Winter Park Hospital. Therefore, NICA contends that Ashton's medical condition meets the statutory definition of "birth-related neurological injury" because his neurological injury occurred "in the course of labor, delivery, or resuscitation." To support its position, NICA presented the (deposition) testimony of Donald C. Willis, M.D., and Laufey Y. Sigurdardottir, M.D. Dr. Willis is board-certified in both obstetrics and maternal fetal medicine. Dr. Willis opined, within his medical expertise, that Ms. Mark went into labor shortly before or just after 3:19 a.m. Dr. Willis explained that "when EMS came [at 3:30 a.m.], [Ms. Mark] was having regular contractions, so I would assume that she was either in labor before that time or labor initiated with rupture of the membranes. . . . I would assume that her labor began somewhere right around 3:19 a.m." Dr. Willis concurred with Petitioners' medical experts that oxygen deprivation occurred at the moment of the umbilical cord prolapse at 3:19 a.m. Dr. Willis explained that "oxygen deprivation can lead to brain injury." Accordingly, Dr. Willis agreed that "there was some degree of brain injury [to Ashton] during that time period [3:19 a.m. through 3:53 a.m.]." However, unlike Dr. James and Dr. Sherbany, Dr. Willis declared that Ashton experienced an ongoing and continuing injury from the cord prolapse through at least 70 minutes after he was delivered at 4:04 a.m. Dr. Willis explained that oxygen deprivation continues until the oxygen returns to the bloodstream and reaches the organs and tissues. Consequently, Ashton's neurological injury progressed through his delivery and into the immediate postdelivery resuscitation period, at least through the time that Ashton continued to experience metabolic acidosis (5:14 a.m.). Accordingly, in Dr. Willis' opinion, Ashton's brain injury due to oxygen deprivation undoubtedly occurred during the labor, delivery, and the immediate postdelivery resuscitation period. However, while agreeing that Ashton began experiencing oxygen deprivation with the umbilical cord prolapse (3:19 a.m.), Dr. Willis testified that he did not "have any way to gauge" the amount of oxygen deprivation between 3:19 a.m. and 3:53 a.m. Therefore, he would not quantify when exactly Ashton's brain injury reached the level of permanent and substantial mental and physical impairment. On the other hand, Dr. Willis was certain Ashton continued to suffer brain injury due to oxygen deprivation during the resuscitation efforts in the immediate postdelivery period. Finally, Dr. Willis refuted Dr. Sherbany's statement that Ashton experienced complete anoxia for any prolonged period (11 minutes) after the umbilical cord prolapse. Dr. Willis did not believe that Ashton would have lived through that situation. Dr. Sigurdardottir is a pediatric neurologist. Alone among the expert witnesses, Dr. Sigurdardottir performed an independent medical evaluation of Ashton on June 27, 2018. Similar to Dr. Willis, Dr. Sigurdardottir testified that the "very, very substantial part" of Ashton's brain injury occurred at Winter Park Hospital in the final couple of minutes just prior to his delivery. Dr. Sigurdardottir declared that Ashton endured a continuum of brain injury due to oxygen deprivation. Dr. Sigurdardottir explained that brain injuries from oxygen deprivation occur exponentially, with the most critical period of injury "at the tail end of the hypoxic ischemic event." Dr. Sigurdardottir opined that the most severe part of Ashton's neurological injury occurred in the few minutes right before his delivery, and extended through the immediate post resuscitative period when Ashton experienced metabolic acidosis. Dr. Sigurdardottir further stated that Ashton's brain injury continued to evolve "within the first week" of his life, when he was most unstable. Dr. Sigurdardottir also commented that, given that hypoxia existed for some undetermined time prior to Ms. Mark's arrival at a hospital, it is difficult, if not impossible, to determine the full extent of the oxygen deprivation that occurred prior to 3:53 a.m. Therefore, it is difficult, if not impossible, to conclude that Ashton incurred a permanent and substantial brain injury prior to his delivery. Accordingly, Dr. Sigurdardottir concluded that Ashton's irreversible brain injury occurred during the final minutes prior to his birth at Winter Park Hospital, and in the hours and days after his delivery. In addition, contrary to Dr. Sherbany and similar to Dr. Willis, Dr. Sigurdardottir unequivocally stated that Ashton did not experience complete lack of oxygen (anoxia) prior to his delivery. Dr. Sigurdardottir rejected any suggestion that the fetus had no heartbeat from 3:19 a.m. until EMS felt a pulse around 3:31 a.m. Dr. Sigurdardottir explained that if Ashton had no heartbeat for 12 minutes prior to his birth, then relieving pressure on the umbilical cord would not have made a difference; Ashton would have been dead at his delivery. However, because EMS was able to detect a pulse after repositioning Ms. Mark on the stretcher, Dr. Sigurdardottir believed that Ashton's heart was beating between 3:19 a.m. and 3:31 a.m. Dr. Sigurdardottir further posited that, if Ashton had been utterly deprived of oxygen (anoxic) prior to 3:53 a.m., some meconium would have been present in the amniotic fluid. However, the EMS personnel who first treated Ms. Mark did not document any meconium from the rupture of membranes. In addition, the operative report from Ashton's delivery at Winter Park Hospital noted that the amniotic fluid was "clear." Therefore, Dr. Sigurdardottir refuted Dr. Sherbany's conclusion that Ashton experienced anoxia (total loss of oxygen) rather than hypoxia (partial loss of oxygen). Winnie Palmer joined NICA in arguing that Ashton suffered a "birth-related neurological injury" as defined in section 766.302. Winnie Palmer presented the expert (deposition) testimony of Donald Null, M.D., and Harry Farb, M.D. Dr. Null is a board-certified neonatologist. In his practice, Dr. Null provides care and treatment to critically ill infants just after delivery. In Dr. Null's opinion, Ms. Mark was experiencing some form of labor, though not "active" labor, when she visited Winnie Palmer at 1:11 a.m. on January 19, 2018. Dr. Null based his opinion on the fact that Ms. Mark was noted to have contractions and "minor" changes in her cervix. Dr. Null explained that active labor is when contractions start happening at a regular and consistent basis, and there is a change in the cervix. Dr. Null believed that Winnie Palmer released Ms. Mark at 2:33 a.m. because her contractions and cervical changes were not progressing. Dr. Null further remarked that Ms. Mark was clearly in labor at the time she presented to Winter Park Hospital at 3:53 a.m. However, Dr. Null qualified his comment by conceding that "I don't really have an opinion of when [Ms. Mark] was or wasn't in labor." Regarding the timing of Ashton's neurologic injury, in Dr. Null's opinion, Ashton had only suffered "mild insult" when Ms. Mark arrived at Winter Park Hospital. Dr. Null explained that a footling breech typically does not result in "total occlusion" of the umbilical cord, only "partial occlusion." In other words, Ashton only experienced hypoxia (partial loss of oxygen to the fetus) not anoxia (total loss of oxygen to the fetus) prior to 3:53 a.m. Dr. Null further opined that the hypoxia was not as severe before Ms. Mark's admission to the hospital as it was during the delivery and resuscitation efforts. Dr. Null testified that Ashton suffered a continuing brain injury from the time of the cord prolapse (3:19 a.m.) until his metabolic acidosis was rectified approximately 70 minutes after his delivery (5:14 a.m.). Dr. Null concluded that Ashton suffered a profound neurological injury, which he referred to as hypoxic ischemic encephalopathy ("HIE"), from the time Ms. Mark arrived at Winter Park Hospital until the time the postdelivery resuscitation efforts concluded. Dr. Null based his opinion on the fact that Ashton's heartrate was measured at 30 beats per minute at delivery, and was most likely at that level at the time Ms. Mark arrived at the hospital. Dr. Null also referred to the fact that Ashton required continuing resuscitation to correct his metabolic acidosis. Dr. Null opined that the HIE was significant enough to cause Ashton's substantial brain injury. Agreeing with Dr. Willis, Dr. Null testified that it is "impossible to quantify" the extent of the oxygen deprivation Ashton suffered between 3:19 a.m. and 3:53 a.m. However, agreeing with Dr. Sigurdardottir, Dr. Null testified that if Ashton had experienced "profound" oxygen deprivation (anoxia) or "a very profound injury prior to arrival" at Winter Park Hospital, he "probably would not have survived the rest of the labor and the resuscitation." Therefore, in concert with Dr. Sigurdardottir's opinion, Dr. Null believed that Ashton sustained the "more substantial portion of his brain injury" after the time Ms. Mark presented at the hospital (3:53 a.m.) and during delivery and postdelivery resuscitation. Dr. Farb is board-certified in both obstetrics and maternal fetal medicine. In Dr. Farb's opinion, the vast majority of Ashton's brain injury occurred after Ms. Mark arrived at Winter Park Hospital. Initially, Dr. Farb testified that Ms. Mark was in labor, "with a qualifier," when she arrived at Winter Park Hospital at 3:53 a.m. Dr. Farb defined labor as "contractions in association with cervical dilation [or change]." Dr. Farb commented that Ms. Mark's "contractions every two minutes could certainly be consistent with labor." However, he did not have any information on the presence of cervical change. Therefore, Dr. Farb issued a "qualified" conclusion that, if Ms. Mark was not in the active phase of labor, then she was at least in the "latent phase of labor." Regarding when Ashton's neurological injury occurred, Dr. Farb acknowledged that some hypoxia occurred prior to Ms. Mark's arrival at the hospital. However, Dr. Farb agreed with the assessments of Dr. Willis, Dr. Sigurdardottir, and Dr. Null that the actual amount of oxygen deprivation cannot be determined. That being said, Dr. Farb, again agreeing with Dr. Willis, Dr. Sigurdardottir, and Dr. Null, believed that "the substantial part of the injury occurred after arrival [at 3:53 a.m.] and into the immediate neonatal resuscitation period." Dr. Farb estimated that "90 percent of the injury at least occurred at and after admission to the hospital." Dr. Farb based his opinion on several factors, including: a footling breech does not cause total umbilical cord occlusion; Ashton's condition worsened from the time of his presentation to the hospital (3:53 a.m.) until delivery (4:04 a.m.); and Ashton experienced "continuous seizure activity" for at least 70 minutes after delivery (through 5:14 a.m.). Dr. Farb further commented that the second ABG draw at 5:14 a.m. showed that Ashton was still severely acidotic, which meant that his brain injury was still progressing. Dr. Farb also explained that a fetus does not immediately suffer a neurological injury at the moment of an umbilical cord prolapse. A fetus has a reserve of oxygen that must be depleted before injury to the brain occurs. Dr. Farb explained that oxygen deprivation (and any resulting brain injury) may not have commenced in Ashton until 10 to 18 minutes after the ruptured membranes and prolapsed cord. Like Dr. Sigurdardottir, Dr. Farb explained that oxygen deprivation is progressive in nature and exacerbates over time. Accordingly, "the severity of the oxygen deprivation was much worse at [Ms. Mark's] admission and [Ashton's] delivery." There was no question in Dr. Farb's mind "that the severity of the oxygen deprivation and the brain injury . . . occurs much closer to the time of delivery because things are progressive and as well as continuing in the immediate resuscitation period." Specifically, Ashton's brain injury continued to occur up to an hour and 10 minutes after his delivery as revealed by his severe metabolic acidosis at 5:14 a.m. In addition, Dr. Farb stated that Ashton's brain was also injured due to constant seizure episodes after his delivery while he was still being resuscitated. Based on the competent substantial evidence in the record, the preponderance of the evidence establishes that Ashton suffered a "birth-related neurological injury" as defined in section 766.302(2). The evidence demonstrates that Ashton began experiencing oxygen deprivation at the time of the umbilical cord prolapse which continued through delivery and immediate postdelivery resuscitation. This oxygen deprivation caused Ashton to sustain a brain injury which has rendered him permanently and substantially mentally and physically impaired. The evidence does not prove that Ms. Mark was in labor prior to Ashton's birth. However, based on the more persuasive medical testimony, the evidence establishes that Ashton suffered injury to his brain, caused by oxygen deprivation, in the course of his delivery and resuscitation in the immediate postdelivery period at Winter Park Hospital. Accordingly, Ashton is eligible for an award of compensation under the Plan.
Findings Of Fact At all times material hereto, the Respondent was licensed as a general physician in the State of Florida, having been issued license number ME0031490. At times pertinent hereto, Dr. Elkadi operated the "Akbar Clinic" in Bay County, Florida. His operation of the clinic consisted generally of performing medical practice of a general nature as well as practice as a general surgeon, including outpatient surgery. He also practiced at Bay Medical Center, where he treated patients admitted under the auspices of other physicians. Dr. Elkadi had no admitting privileges at Bay Medical Center. The Petitioner is an agency of the State of Florida charged with regulating and enforcing the medical practice standards and licensure standards embodied in Chapter 458, Florida Statutes, including the standards of practice involved in the dispute in this case. Ms. Eunice Stallings was a patient of the Respondent on March 19, 1985, on which date she came to his clinic. She was 70 years of age. After performing some tests and observing the results, Dr. Elkadi informed her that she suffered from gall stones. She filled out a form in his office indicating that she had previously had a tonsillectomy, an appendectomy, a lobectomy and a hysterectomy. The doctor mentioned that she could be admitted to the hospital for surgery or could use his clinic. She elected to stay at the clinic and have the surgery there on account of the greater expense she believed involved with a hospital admission. She did not have any discussions with Dr. Elkadi concerning possible complications or risks associated with the gall bladder surgery prior to the surgery. Her daughter, Ms. Ted Cowens, went to the clinic with her on the day of the surgery. She arrived shortly after 7:00 a.m. on that day. A clinical employee escorted Ms. Stallings to the room to have her change into a surgical gown. Dr. Elkadi had discussed earlier with Ms. Stallings the possibility of staying in a nursing home or something of that nature after the surgery, for recovery. She assumed that the clinic would make the arrangements for that recovery procedure. She was not informed that she might have to stay beyond 24 hours in the clinic's facility. She was not informed prior to the surgery that Dr. Elkadi had no admitting privileges to the hospital, if complications should arise necessitating hospital admission. Ms. Cowens remained at the waiting room from 7:00 a.m. until 2:00 p.m. of March 19, 1985, while her mother-in-law was undergoing the cholecystectomy (gall bladder removal). She saw her mother-in-law at 2:00 p.m. that afternoon and observed that she was attached to a heart monitor and was breathing oxygen with difficulty. Ms. Cowens inquired about the circumstances and was informed by a person who identified herself as a nurse that Ms. Stallings had run into a problem with her lung. She was having difficulty breathing at the time. Ms. Cowens observed a person who identified herself as "Joyce" acting as a nurse right after the surgery. When she returned at 5:00 a.m. the next morning on March 20 to the clinic to see her mother-in-law, Joyce indicated that she had been the sole person on duty with Ms. Stallings during the entire night. She also indicated she had tried to get another person to be on duty, but was unable to do so. Ms. Stallings at this time was still coughing and spitting blood and continued to do so until her transfer from the Akbar Clinic to Bay Memorial Hospital by the Respondent and Dr. Albibi, based upon the other doctor's admitting privileges, at approximately 5:00, on March 20, 1985. Charles Wheelahan is an investigator for the Department of Professional Regulation and interviewed the Respondent in his Panama City office. The Respondent gave him copies of medical records regarding the Stallings case and informed him that a small respiratory problem, involving slight lung congestion, had occurred shortly after Ms. Stallings' operation, while she was still a patient in the clinic. Dr. Elkadi informed the investigator that he had made application to be licensed as a "hospital," but that license application had been denied by the Department of Health and Rehabilitative Services (HRS) and that he was in the process of applying to be licensed as a "surgical center." He also informed the investigator that the nurse on duty with Ms. Stallings on the night of March 19-20, 1985, was Joyce L. Snow. She was a Licensed Registered Nurse in Great Britain, but was unlicensed in the State of Florida. The doctor, in response to a question from Investigator Wheelahan, informed him that he did not maintain any blood supply on the clinic premises, but could obtain blood from the county hospital if needed. In any event, he informed the investigator that only a minor blood loss was expected and actually experienced during the cholecysteotomy surgery and that it would have been anywhere from 20 to 100 cc's blood loss. The investigator also established that a person known as Olga Sutter, apparently an employee of the clinic, was also present and cared for Ms. Stallings during some of the time she was a patient at the Akbar Clinic. Dr. John L. Williams testified as an expert witness on behalf of the Petitioner. He is a Florida licensed physician and general surgeon and has been in private practice in Tallahassee since 1970. He is Board-certified in surgery and belongs to numerous medical societies. His primary practice emphasis has been in direct patient care. Dr. Williams reviewed the hospital and office notes concerning Ms. Stallings, which comprise Exhibits 5A and 5B in evidence. The medical records reveal that Ms. Stallings went into respiratory distress post-operatively, which ended up as acute congestive heart failure, for which she was treated. The doctor's and nurse's notes reflect that she had become short of breath and that her blood pressure fell and that she ultimately became cyanotic. Blood gas test results proved the fact of her congestive heart failure condition. Dr. Williams felt that, although the treatment was adequate in the end result, there should have been some contingency plans developed in advance for handling any disaster or crisis that arose involving the pulmonary edema or bleeding suffered by the patient. The medical records and notes and evidence of record do not reveal that the Respondent had any such contingency plans for handling crises developing from performing such surgery in an outpatient setting. The operation, as shown by Dr. Williams, would have been more appropriately performed in a hospital setting so that the patient would have the crisis-handling ability of the hospital systems and staff during her overnight stay. It was his opinion that, given the history of lung trouble, wheezing, scarring of the chest, as well as her age, that this type of surgery should not have been done in the outpatient setting. Dr. Williams' expert opinion is accepted. Dr. Paul Lahti is an expert witness for Respondent and a retired general surgeon from Michigan. He reviewed the records of the Stallings case and found nothing inappropriate about Dr. Elkadi's care of Ms. Stallings. He stated that the doctor's actions avoided a catastrophe. He also stated that same-day surgery is recognized in 48 states. He has not practiced medicine in Florida. He also has spent a substantial amount of time writing, lecturing and advocating the cause of same-day outpatient surgery. I find his testimony significantly colored by his somewhat partisan view, advocating that a broad range of surgical procedures be performed as outpatient same-day surgery. His opinion appeared based on that and on the fact that nothing inappropriate was determined by him to have been done by the Respondent in his care of Ms. Stallings in terms of the end result. Dr. Edward Woodward, a professor of surgery, from the University of Florida, was also Respondent's expert witness. He likewise found the care of the patient itself appropriate and did not feel the problems she experienced were clinically important. Dr. Williams, the Petitioner's expert himself, however, did not find the actual techniques of the treatment afforded the patient, including that afforded her after the respiratory and congestive heart failure crisis arose, to be inappropriate. The problem was, that it was substandard medical practice, as related above, to handle such a serious surgical procedure for a patient of her age and with her previous health history as an outpatient surgical case. Appropriate medical practice would have dictated that a patient such as this be hospitalized before such surgical treatment. Dr. Woodward, one of Respondent's experts, also felt that it was the surgeon's duty in a case such as this to anticipate problems that may occur during or after surgery. Thus, in this context, and because of his more thorough review of pertinent records, Dr. Williams' expert opinion is the more valid one and is accepted over the others. Expert Witnesses Four experts were called by the Petitioner and Respondent to testify and give expert opinion testimony concerning the nine patients related to Case No. 86-1327, which will now be addressed. Dr. John L. Williams, general surgeon and expert for Petitioner, testified that he reviewed all the cases, involving hospital charts and office notes and other records, in its entirety, spending more than 30 hours reviewing them. Dr. Millard Roberts, a gastroenterologist and expert for Petitioner, read all of the hospital and office notes, which are exhibits, and spent more than 50 hours reviewing them. Dr. David Skinner is Chairman of the Department of Surgery at the University of Chicago and an expert for the Respondent. He stated in his deposition that he read abstracts of the medical records, contained in Respondent's Exhibit 7 in evidence, sent to him by the Respondent. He did not compare those prepared abstracts with the actual medical records which Dr. Williams and Dr. Roberts had reviewed. See Respondent's Exhibit 6, pages 17-21. Dr. Skinner spent approximately seven hours reviewing abstracts of the records furnished him by the Respondent himself, Dr. Edward Woodward is professor at the University of Florida. He stated that he reviewed the hospital charts, but no office records concerning the patients involved. He also looked at the Respondent's attorney's summary of notes to supplement his factual basis for rendering an opinion. The evidence did not reflect what length of time Dr. Woodward spent reviewing this material.. The Surgical Procedure at Issue Fundoplication is the surgical procedure under question in the nine cases comprising Case No. 86-1327. This procedure is designed to prevent "reflux" or regurgitation of stomach contents from the stomach up into the esophagus. "Reflux esophagitis" is the chronic inflammation of the esophagus due to the reflux of gastric juices into the esophagus for various reasons. Reflux esophagitis, if severe enough, may cause scarring or narrowing in the esophagus. Reflux esophagitis is an indication to perform the surgical procedure called fundoplication in those cases in which reflux is due to an inherent weakness in the junction of the stomach and the esophagus. The most common symptom of reflux esophagitis is a substernal burning or discomfort after eating, which is commonly referred to as heartburn. A further symptom is regurgitation of food when the patient bends over or lies flat after large meals. Other less specific symptoms of the condition involve upper abdominal pain. Ruth Cooey is a 73-year-old female who complained of epigastric pain upon admission by the Respondent. The patient had a history of taking Tagamet and antacids for one year. One year prior to admission, an upper GI examination was done which revealed an esophageal hiatal hernia and a duodenal ulcer. Her past history included arthritis with a left total hip replacement, hypertensive cardiovascular disease and a total abdominal hysterectomy. Following her admission to the hospital, Dr. Elkadi entered the case, treating the patient with Tagamet and Regulon. The patient's history contained notes of recurrent epiastic pain, nausea, choking spells and heartburn radiating behind the sternum for several years. Shortly before hospitalization, peptic ulcer had been demonstrated, as well as a hiatal hernia, which the Respondent confirmed. A "Bernstein test" was then conducted. A Bernstein test is designed to reproduce "heartburn" in most cases. The results are not always accurate. The Bernstein test was done three days after admission, with negative results. The results were not noted by Dr. Elkadi in his summary, however. Dr. Elkadi performed an endoscopy with the distal esophagus being described as compatible with chronic esophagitis. There was a "small sliding hiatal hernia with intermedial reflux." The records also reveal a description of two shallow ulcers of three to four millimeters each, in the prepyloric area and a large pyloric channel ulcer, described as being eight to ten millimeters in diameter. Biopsies taken during endoscopy showed chronic esophagitis and revealed chronic inflammation in the prepyloric mucosa. Dr. Elkadi performed a vagotomy, a pyloroplasty, and a Nissen Fundoplication on or about June 8, 1983. Dr. John Williams, the Petitioner's expert, opined that the reflux this patient had experienced was due to the primary disease of pyloric channel ulcer, which can cause reflux and thus produce symptoms of heartburn. If she had an intrinsic weakness of the esophagastric junction, a primary indication for a fundoplication procedure, then she would have had the symptoms before she was 73 years of age and not just had them occur after she had the ulcer. It was Dr. Williams' opinion that fundoplasty, the surgical procedure at issue, was really not indicated in this case. The symptoms exhibited for reflux esophagitis, which would justify the fundoplication were not present in this case. The symptoms existing were likely due to the ulcer as opposed to esophagitis. The symptoms the Respondent listed which he felt showed reflux esophagitis were pain after meals (thirty minutes to an hour and relieved by antacid), heartburn, and the epigastric pain described by Dr. Zawahry in June 1981. It might be noted that Dr. Zawahry, at that time, did not note any choking, dysphagia (difficulty in swallowing) or substernal pain, which are indications for fundoplication. The documentation of those symptoms came from the Respondent's notes. Dr. Williams felt the written records from the charts at the hospital did not justify the need for the fundoplication which was done. Her primary problem was a peptic ulcer. The esophagasoopy did show some esophagitis, which is evidence that some material was getting into the esophagus from the stomach or digestive tract below, but that was caused by the ulcer disease. Dr. Williams indicated that the treatment noted on those written records was below appropriate performance standards for a reasonable physician under reasonable similar conditions and circumstances, as there was no indication that the symptoms exhibited indicated the need for the fundoplication surgery. Dr. Millard Roberts, a gastroenterologist and licensed physician in the State of Florida, is a private practitioner in Tallahassee. He was qualified as an expert witness for the Petitioner in the field of gasroenterology. He received his undergraduate degree from the University of Florida and his medical degree from the University of Miami Medical School. He has admission privileges at Tallahassee Memorial Regional Medical Center and Tallahassee Community Hospital and presently serves on the Medical Records Review Committee of both those hospitals. He has practiced for sixteen years and attends numerous conferences and training sessions within his field of gastroenterology to keep his knowledge and skills current. He formerly practiced in that field, as well as in internal medicine, in Dothan, Alabama, His primary emphasis has been on the symptomology of the patients, which he obtains by taking a history, a physical examination, performing certain studies and arriving at impressions after completing examinations and observing the results of tests or studies. The standard practice in the medical community for determining whether or not symptoms are properly documented in records is based on rules promulgated by the Joint Commission on Accreditation of Hospitals, which method was employed by most hospitals in the country in 1985. Dr. Roberts discussed the various symptoms of esophageal reflux disease, including heartburn, difficulty in swallowing or painful swallowing (dysphagia), regurgitation or reflux of material as high as the throat or mouth. The symptoms noted in the hospital chart of the Cooey case, in his opinion, were related to ulcer, rather than to esophageal reflux disease. There was an absence of symptoms such as heartburn, dysphagia, choking and substernal pain. These symptoms were not noted in Dr. Zawahry's reports. He only reported epigastric pain. Dr. Roberts stated that it would be expected to see the other symptoms of esophageal reflux disease he noted appear in the patient's previous medical records made by Dr. Zawahry. Dr. Elkadi's consultation report is the first time these symptoms are mentioned. Dr. Roberts also pointed out that the Bernstein test is commonly used to confirm reflux esophagitis, but in Ruth Cooey's case the test was negative. It was negative on June 5, three days prior to the June 8 surgery. Dr. Roberts found nothing in the record occurring between the date of the Bernstein best and the date of the surgery three days later to confirm the necessity for doing a fundoplication. He further established that there was nothing in the radiologist's report to indicate any tertiary contractions of the esophagus, which would indicate a motility disturbance, which would be a justifying symptom. Dr. Elkadi's note is the only record he saw which is in any way supportive of the surgery. Dr. Roberts stated that the lack of symptomology to justify the fundoplication led him to conclude that the level of care and treatment fell below that of similar physicians practicing in similar conditions and circumstances. The other surgical procedure (for ulcers) should have taken care of the symptoms that were exhibited in the record without the necessity of the Respondent doing the fundoplication. The Respondent's expert, Dr. Woodward, agreed that the hospital charts and records did not give a clear history of reflux esophagitis in this patient. He also felt it was inexcusable not to have the information from the office notes on the hospital charts. He himself had reservations about the performance of the Nissen Fundoplication in this case, but would not call it malpractice. Dr, Skinner, the Respondent's other expert witness, testified in his deposition that the operation was appropriate. Based upon their greater familiarity with the circumstances of this case, including their more extensive survey and consideration of the records involved and their more direct experience in gastroenterological practice and surgery, I accept the opinions of Drs. Williams and Roberts over that of Drs. Woodward and Skinner. Debra Crosby is a 28-year-old female with a history of morbid obesity. She was admitted to Bay Memorial under the Respondent's care with a history, over the past few weeks, of nausea and dyspepsia, which is epigastric distress after eating greasy, fried foods. She had a past history of acid indigestion. The Respondent immediately ruled out gall bladder disease, the patient having been admitted for abdominal pain as well. The secondary reason for admission was for "morbid obesity," to conduct a surgery to allow the patient to reduce her obese condition. Such surgery limits the intake of food and the ability of the intestines to absorb food to some extent. The patient had surgery to correct morbid obesity. That surgery is called a "Roux-en-y" gastric bypass. That surgery involves making a small pouch near the upper part of the stomach, bringing the small intestine up and attaching it to that pouch so that the patient is only able to eat a limited amount at a time. Dr. Williams opined that that was an appropriate procedure to use for "bariatric surgery," that is, to relieve obesity, although he himself prefers the "vertical bend gastric partition procedure." No gastroesophageal reflux symptoms were documented in this case. In any event, on the 22nd of July, shortly before surgery, the patient was vomiting and suffering epigastric distress. They performed a "GI series" or barium- assisted X-ray of the upper digestive tract. While the patient was actually in the process of vomiting, a small hiatal hernia was demonstrated. Because of the vomiting, they had to abandon the upper GI series test. It was postponed until the next day, at which time another upper GI series test showed normal with no sign of hiatal hernia. So no esophageal reflux condition was demonstrated, nor was there any significant indication of hiatal hernia, which can cause a reflux condition in the esophagus. An ultrasound test of the gall bladder established that there were no gall stones, and her gall bladder appeared normal. She then had surgery for the gastric bypass procedure and also had a fundoplasty. The fundoplasty or fundoplication involved suturing the anterior wall of the stomach pouch to the anterior wall of the esophagus on one side. Only one side of the stomach was sutured up, and Dr. Williams established that fundoplasties all should be characterized by a "wrap" of some sort of the stomach around the base of the esophagus. The manner in which the surgery was described in the Respondent's operation note does not reveal that he could possibly do the appropriate fundoplication wrap procedure in that manner, with only a partial wrap. Esophageal reflux disease usually disappears with weight loss. With surgery to correct morbid obesity, accepted medical practice dictates that reflux-correcting procedures (fundoplasty) not be done. The reduction of the obesity greatly relieves the problem of reflux, and the gastric bypass surgical procedure is effective in preventing reflux of bile and juices itself. In Dr. Williams' opinion, which is accepted, there were no specific symptoms showing a reflux condition. There were some nonspecific symptoms that could possibly have been attributed to reflux involving epigastric pain or acid indigestion. The nausea and vomiting could have been due to many causes, but Dr. Williams thinks most likely that she suffered from gall bladder disease in spite of the fact that she did not have any stones. So, her symptoms could have been due to gall bladder disease, just acid indigestion, obesity or reflux. There were no clear-cut symptoms to justify the anti-reflux operation, however, because the patient had no symptoms of reflux before she had an acute illness, which caused her hospitalization. She was simply morbidly obese and correction of that problem would solve also any reflux symptoms she may have been-having. In summary, the medical records of this patient, maintained by the Respondent, did not justify an anti-reflux procedure such as fundoplasty. In any event, Dr. Williams opined that the procedure that was done would not prevent reflux anyway, even though it was unnecessary. This is so because an appropriate wrap of the stomach around the esophagus was not done. So, as established by Dr. Williams, the partial wrap, fundoplication procedure was supefuous and should not have been performed. Dr. Roberts also reviewed the Crosby case and opined that the gastroesophageal reflux condition would disappear with weight loss, brought on by the Roux-en-y procedure. When the pressure within the stomach exceeds the pressure of the lower esophagus sphincter muscle designed to prevent the reflux or regurgitation, then reflux can occur. The obesity causes a thickness and weight on the abdominal wall which pressures the stomach. The increase in the intraluminal pressure of the stomach enhances the possibility that reflux will occur. Therefore, prevention of increase of intraluminal pressure of the stomach would decrease the likelihood of reflux occurring. The documented symptoms of esophageal reflux disease, such as heartburn, dysphagia, chest pain, chronic cough and epigastric pain were not present in this patient, with the exception of some heartburn pre-operatively. Dr. Roberts established that the written records for this particular patient do not justify, by symptomology recorded, the necessity of doing a fundoplication procedure. Dr. Roberts thus corroborated the finding by Dr. Williams that the treatment and care of this particular patient fell below accepted standards for reasonable physicians under reasonable similar circumstances and conditions, since the indications for the fundoplication procedure were not present in the patient's records. Dr. Skinner opined once again that he felt the operation was appropriate. Dr. Woodward, however, questioned the necessity of the repair of the hiatus hernia and the anti-reflux operation or fundoplication. He felt that with weight loss the reflux condition would disappear with the lessening of pressure on the stomach and that therefore it was probably unnecessary, although he did not go so far as to call it a situation of malpractice. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Patient Dorothy Kay was a 68-year-old female with a history of diabetes, cardiovascular disease and legal blindness. She also had some urinary and renal system dysfunction, with hyperemia. She was admitted by Dr. Kahn in June 1981 for abdominal pain, nausea and vomiting of one day duration. She had had three black bowel movements immediately before admission, but these were not tested for blood. Since her hemoglobin level was normal on admission and remained normal, Dr. Williams, in his testimony, discounted the possibility that she had gastrointestinal bleeding. She was thoroughly evaluated after admission, and her gall bladder proved normal. An upper GI examination showed a small hiatal hernia, but with no reflux, on June 15. Examinations of the kidney and a CAT scan of the abdomen were not remarkable, and a barium enema on the 22nd of June revealed some diverticulosis. She had a problem with constipation at this same time, which could have explained some of her complaints of abdominal pain, especially because the abdominal pain ceased after the barium enema, according to the nurse's notes. An endoscopy was performed on June 18 to examine the esophagus and stomach area. The esophagus showed some chronic inflammation. This can either occur as a normal occurrence or as a result of some disease process. This particular patient's history revealed that she had arthritis and had been taking a substantial dosage of Motrin, at 600 milligrams per day. Motrin is one of the drugs that can cause gastrointestinal and peptic symptoms. It can produce ulcers and bleeding. The patient had been maintained on this dosage of Motrin until two days before surgery, which is quite a significant dose. Dr. Williams also found that the abdominal pain was relieved upon administration of saline injections. H3, therefore, thinks the abdominal pain was most likely due to functional disease associated with diabetes and may well have been caused by the Motrin medication. In any event, there was no evidence in her history which would indicate that reflux esophagitis (the indication for a fundoplication procedure) was the cause of her pain. Even Dr. Elkadi's admission notes noted that her tenderness was more prominent in the lower abdomen than in the upper abdomen. The patient was operated on and had a needled biopsy of the liver and the fundoplication procedure, as well as a "lysis" of adhesions. The operation notes were not written until two months after the surgical procedures were done. Operative notes are customarily done at the time of surgery and on the same day if possible, so that the physician will not be as likely to forget details of the procedure as he would if they were dictated two months later. The operative notes on the fundoplasty procedure were done on August 19. The surgery was performed on June 25. Dr. Williams established that the records on this patient simply did not show symptoms of reflux esophagitis, an indication for the fundoplasty. The esophagoscopy was not valid evidence, standing alone, of reflux esophagitis, and that was the only possible suggestion that a chronic reflux condition existed. Dr. Williams established that the small degree of change observed in that procedure, due to reflux, was due to vomiting of the rather short historical duration occurring immediately prior to her admission. The Motrin medication she was taking could, itself, have caused her symptoms. The minimal chronic inflammation of the esophagus was not shown to be due to any defect in the gastroesophageal joint, but could have been due to any number of conditions in a diabetic, aged and infirmed patient like this and most likely was due to the recent vomiting, which is of undiagnosed etiology. Dr. Roberts referred to Dr. Elkadi's consultation of June 12, 1981, wherein he noted that the woman had been having abdominal pain for seven years, progressively worsening. Dr. Roberts did not feel that indicated reflux esophagitis. The reason he did not think so was because there was no mention made of any heartburn pain or difficulty in swallowing as to the upper abdominal area or chest area. There was also no mention in any of the notes or records that the patient was developing any strangling sensations or symptoms suggestions aspiration of gastric contents, bleeding or hemorrhaging, which would be suggestive of sever ulceration of the esophagus. Dr. Roberts agreed with Dr. Williams that this patient's records do not in any way indicate symptomology, clinical or otherwise, which would confirm a diagnosis of reflux esophagitis, indicative of a fundoplication procedure. Dr. Woodward, the Respondent's expert, also felt that the fundoplication was unnecessary. He found no history suggestive of reflux esophagitis and felt that such elective surgery in a person who was this sick, with diabetes and related problems, was a poor idea. He also found it unforgivable that the history was not more descriptive of the patient's problems and that the history concerning the patient's medication regime was not documented in the hospital chart. The doctor was opposed to the patient having this operation but, because of "mitigating circumstances" which he never fully explained in his testimony, would not call this a situation of malpractice either. In any event, based upon the testimony of Drs. Williams and Roberts and corroborated to some extent by that of Dr. Woodward it is found that Dr. Elkadi's treatment of this patient was inconsistent with quality medical care and fell below appropriate standards of practice for similar physicians practicing under similar conditions and circumstances. Agnes McNeil is a 42-year-old female with a history of depression, nausea, vomiting and abdominal pain. She was admitted to the hospital in October 1981 with approximately a six month history of abdominal distress and vomiting. A GI series was performed showing normal results and an upper gastrointestinal and endoscopy showed some esophagtis. There was also a finding made that she had a duodenal ulcer with some reflux. That finding was made October 31, 1981. She was admitted again on the 8th of March, 1982. On March 11, she had an "upper end endoscopy" and was said to have a hiatal hernia with reflux and duodenal ulcer, on the pylorus. The esophagus, however, was normal, and the GI series was negative once again. It showed no hiatal hernia and no reflux. She had surgery for the duodenal ulcer in the pyloric channel. The procedure done was a "highly selective vagotomy" which is done to inhibit the secretion of acid by the stomach. This is a rather new procedure and is not statistically as effective as some other procedures for the same condition. Additionally, the Respondent did a fundoplasty. The fundoplasty was not properly indicated, as established by Dr. Williams, because the significant changes in the esophagus which would indicate such a procedure were not present. The past reflux condition occurring in October 1981 was due to the acute ulcer condition. There had been no significant history of reflux prior to the onset of the peptic ulcer disease. If reflux was present, then the patient should have experienced some regurgitation upon bending over or waking up at night, as well as burning in the chest upon lying down at night, and none of this appeared in the record. A biopsy was done in this case which indicated acute esophagitis, and the patient had suffered severe weight loss, but this, in Dr. Williams' opinion, is related to the peptic ulcer condition and is justification for a vagotomy procedure, either the normal type or the new and somewhat controversial, highly selective vagotomy which Dr. Williams guardedly agreed with. In any event, however, he established that the fundoplasty was not ordered because the evidence of reflux esophagitis in the patient was directly related to the peptic ulcer disease and the procedure to effect a of that problem could be expected to alleviate the eophagitis. In any event, post-operatively, the patient still continued to have upper abdominal pain, nausea and vomiting. The obstruction in the pyloric area caused the reflux and caused the vomiting. The constant vomiting resulted in the inflammation or esophagitis condition. Pyloric channel ulcers cause obstruction which causes vomiting, and vomiting by definition is "reflux." The removal of the cause of the vomiting will also, over time, heal the esophagitis, without the necessity of a partial fundoplasty, as was done in this case. Dr. Roberts, in reviewing the McNeil patient records and notes, found that the upper GI series and the pathology in this particular case did not show significant evidence of reflux esophagitis. Three different "upper GI series" before and after she surgery, were interpreted as normal. His testimony, in effect directly corroborates that of Dr. Williams in establishing that the performance of the fundoplication as treatment in this case was below accepted standards of practice or a reasonable physician practicing under similar conditions and circumstances. Although he did not testify in his deposition that the Respondent fell below the standard and committed malpractice, Dr. Woodward, the Respondent's expert, also questioned and doubted whether the patient needed the Nissen. Fundoplication in view of the medical records he was given to review. Ms. Nguyen was a 77-year-old Vietnamese female at the time of her admission to the hospital by Dr. Kahn in December 1981. Her complaints were abdominal pain, nausea, vomiting, constipation, dehydration and fainting. She had been unable to urinate for approximately 24 hours prior to admission. These conditions are revealed by the notes, but the failure to urinate for approximately 24 hours is inconsistent with the dehydration symptom noted. In any event, she is a Vietnamese national and did not speak English. Communication with the Respondent, whose service she was admitted on, was difficult. It was thus difficult to get an adequate history from her, which made the history somewhat sparse. During her hospitalization, on December 19, Dr. Elkadi noted some "right upper quadrant tenderness." Dr. Elkadi had been consulted on the 18th of December and had noted at that time nausea, vomiting, right upper quadrant tenderness and constipation. Gall bladder X-rays showed probable gall stones or "sludge" in the gall bladder, and a GI series indicated a small hiatal hernia, without mention of reflux. An abdominal ulcer sound test was performed which showed sludge or small stones in the gall bladder. Gall bladder disease fit the physical findings of right upper quadrant tenderness, acute onset of nausea and vomiting and also the history of the patient not having a good appetite, being nauseated over the course of the year and losing a significant amount of weight. She only weighed 87 pounds upon admission. An endoscopy was performed, as a result of which Dr. Elkadi described the patient as having distal esophagitis, moderate erythema and edema, as well as a small hiatus hernia. A cholecystectomy was performed for removal of the gall bladder. There were no symptoms other than nausea and vomiting which would justify a finding that reflux esophagitis was present and that therefore anti- reflux surgery might be indicated. A small hiatal hernia was not significant, and there was minimal esophagitis shown by the endoscopy done immediately prior to surgery. What esophagitis evidence was present was due to the nausea and vomiting related to the gall bladder disease. Dr. Elkadi performed a fundoplication procedure anyway. Performance of a fundoplication is additionally risky for a person who is frequently vomiting, and the fundoplication was shown by Dr. Williams to be unnecessary in this case. The nausea and vomiting were not symptoms of reflux disease, but rather were symptoms of the gall bladder disease. The small hiatal hernia did not justify anti-reflux surgery in this case because that is frequently seen in older people and is not significant in itself. Additionally, although Dr. Elkadi's records showed that he removed a large gastric tumor, in reality that tumor was only one centimeter in diameter sitting on the surface of the stomach and was of no consequence in the patient's condition or related to any of her symptoms. The symptoms of right upper quadrant pain, nausea and vomiting, and the test results, justified the cholecystectomy (gall bladder) procedure, which is what Dr. Elkadi should have done and then stopped. He should have determined whether that alleviated the patient's symptoms, rather than doing the unnecessary fundoplication when the record did not reveal any significant reflux esophagitis indications, and since that procedure represents an additional risk to the patient. In summary, it was established by Dr. Williams that the records were not adequate to justify the fundoplication performed in this case. The performing of it unnecessarily constituted a failure to practice medicine with that degree of care and treatment required of physicians under similar circumstances. It is especially true in the case of a patient such as this, who is old and feeble at best. Performing an unnecessary operation on such a sick, 77-year-old patient increases the mortality risk somewhat and increases the post-operative morbidity risk significantly because the patient will not be able to "burp" any longer and can become subject to "gas bloat," as well as the risk of having difficulty swallowing because the "fundoplication wrap" might be too tight. The fact that it constituted malpractice to proceed forward with the unnecessary fundoplication is especially pointed up by the fact that Dr. Elkadi's own notes reveal that he was unable to understand the patient, who could not speak English, and thus was unable to get an adequate history. If the history is unclear because of a language problem and the doctor cannot understand the patient to make sure of the extent and nature of the symptoms, it is not reasonable to proceed with the operation, as opposed to trying to find an interpreter who can help the physician ascertain clearly what the symptoms are and what the indications for treatment are. Dr. Roberts, likewise, was unable to find any proof in the hospital records of the presence of any reflux esophagitis and felt that the fundoplication was unjustified. In fact, as he pointed out, Dr. Elkadi himself in his operative notes indicated that the limited history he was able to obtain from the patient was not specific enough to distinguish between gall bladder symptoms and gastroesophageal reflux symptoms. Dr. Roberts thus felt that the treatment of this patient fell below acceptable standards of a similar physician under similar circumstances. Dr. Woodward, the Respondent's expert, was unable to determine what was wrong with the patient and found that the hospital chart did not clarify it for him. The purpose of a patient history, according to Dr. Woodward, is to give a word picture of a patient's problem, and he found that the history, in addition to being inadequate, did not indicate any reflux esophagitis. He agreed with Drs. Williams and Roberts that the cholecystectomy was needed, but it was unlikely that the patient really needed anti- refluxsurgery (fundoplication). The additional operation, in addition to being unnecessary, added to the patient's mortality risk and post-operative morbidity. It has therefore been established that, as to this patient, the practice of the Respondent and his treatment of the patient fell below the acceptable standards for similar physicians practicing under similar conditions and circumstances. Rosey Peel was a 66-year-old lady admitted in May 1982 to Dr. Elkadi's service with a history of gastrojejunostomy, appendectomy, total abdominal hysterectomy, with associated adhesions. In October 1980, she had had a history of duodenal ulcer which was medically treated, as well as a history of stomach erosions and bowel gastritis treated medically in May 1981. In April 1982, she underwent an endoscopy, and the pathology report indicates the presence of chronic esophagitis and inflammation of the gastrojejunostomy. She had a history at this time of epigastric pain, nausea and vomiting. The endoscopy showed ulcers in the jejunum at the site of the gastrojejunostomy or the "rough equivalent to the pyloric channel." Thus, the patient had active peptic ulcer disease with related endoscopic evidence of bile in the stomach and in the esophagus. She underwent a vagotomy as a correction for the ulcer disease and a resection of the distal stomach, which disconnected the stomach from the duodenum in order to get rid of the problem of bile entering the stomach and causing the reflux esophagitis. The reconnection process was done in the form of a Roux-en-y procedure or gastric bypass, which has the effect of preventing the bile from entering the stomach. As opined by Dr. Williams, these procedures would alleviate her problem involving the ulcer disease, the reflux biliary gastritis and esophagitis. Consequently, she did not need the fundoplasty procedure, and it was unnecessary. The anti-reflux procedure did not have to be done, and the primary disease process, peptic ulcer disease, would have been alleviated by the Roux-en-y gastrojejunostomy and the vagotomy. Dr. Williams opined that when an operation like this that is unnecessary is done, then strictly speaking malpractice has been committed. He acknowledged, however, that it was possible to interpret her symptoms and records as indicating reflux biliary gastritis, which could have easily led the Respondent to believe that a fundoplication procedure could cure her problem. In fact, it was not necessary to cure the reflux problem she was having, as delineated above. In this particular case, standing alone, it might be said that, given the presence of reflux biliary gastritis and esophagitis, that a practitioner could make a good faith mistake in performing a fundoplication, rather than limiting the surgery to the Roux-en-y repair and the complete vagotomy. Dr. Roberts, after reviewing this patient's file, was unable to find symptomology in the record which would justify the fundoplication. The abdominal pain, nausea and vomiting, which had worsened over several months, were related, in his opinion as well as Dr. Williams', to bile reflux gastritis. Reflux in and of itself is not justification for surgery, especially when the patient is not complaining of chronic reflux esophagitis symptoms. The reflux can be due to other causes, as mentioned above, including the pyloric ulcer situation this patient suffered. He opined that the esophageal reflux situation and the delayed gastric emptying would have been relieved with just the procedures performed short of the fundoplication, as did Dr. Williams. Inasmuch as Dr. Williams felt that this single instance of performing the fundoplication, albeit necessary, could not by itself be called malpractice, since enough symptomology was present to lead a competent practitioner into performing it as a result of a good faith mistake, and since both Respondent's experts felt that the procedure was documented in this case, it cannot be found that this instance, standing alone, was gross or repeated malpractice. It has, however, been proven that the procedure was medically unnecessary. Considered together with the other unnecessary surgeries discussed in these Findings of Fact, however, the overall pattern is one of medical treatment which does not measure up to the standards of reasonable physicians performing such practice and treatment under similar conditions and circumstances. Ms. Rosey Smith is a 63-year-old female with a history of total abdominal hysterectomy, right nephrectomy and adhesion laparotomy, both of which procedures were performed in 1950; cholecystectomy performed in 1962; and hiatal hernia repair performed in 1980. She was admitted to the Respondent's service in 1981 complaining of epigastric pain. An endoscopy performed revealed moderate, chronic esophagitis, but the pathology report failed to confirm esophagitis and was interpreted as being without evidence of inflammation of either the esophagus or gastric mucosa. She was admitted by Dr. Kahn and subsequently consulted by Dr. Elkadi. She had had a Nissei Fundoplication for reflux esophagitis in November 1980. She was admitted again on this occasion in September 1981 with nausea and epigastric pain. Since her surgery in 1980, she has been unable to eat well because of fullness and pain after eating. She had upper gastrointestinal pain upon admission, and the endoscopy performed showed that she had a slight amount of esophagitis. However, biopsy of the stomach and the esophagus were normal. The upper GI series performed failed to show any reflux. It showed tertiary contractions of the esophagitis (spasms) and some delayed emptying of the stomach, as well as some deformity of the antrum of the stomach. That deformity did not have any significance, especially in view of the fact that the endoscopy failed to show any ulcers in that area. Dr. Williams did not feel that the delayed emptying of the stomach was significant either, and he found no evidence of reflux. The Respondent then performed a vagotomy after taking down the previous fundoplasty in order to get to the vagus nerve to do the vagotomy, which is indicated for peptic ulcer disease. Thereafter, he had to redo the fundoplasty, which had previously been done in 1980. Dr. Williams felt that the lady's problem was probably dysfunctional and probably related to her first surgery. After the first fundoplication, she exhibited the same complaints she had before. She had been treated previously with Tagamet and, if she did have peptic ulcer disease, the endoscopy did not reveal it to be significant. Thus she did not need this further surgery which also left her with the same complaint she had before. A month after this surgery some dysphagia or difficulty in swallowing as well as esophageal dilation was experienced. These are symptoms of the so-called "gas bloat syndrome." This is involved with fullness and pain after eating and is a complication of a fundoplication. Dr. Williams found that she did not have significant esophagitis, and the problem was more likely "gas bloat" or some undiagnosed, dysfunctional gastrointestinal disease. She did not have an active ulcer and had no significant reflux. Additionally, the "3 plus" positive standard reflux test is not in and of itself sufficient evidence to justify a fundoplication. This test can be positive and still not represent any symptomatic condition. Dr. Williams thus opined that the performance of the fundoplication being taken down, a vagotomy performed and the fundoplication being redone (which was necessary once it was "taken down") was below the acceptable standards of a reasonable physician under similar circumstances and conditions in light of the symptoms exhibited. In a like vein, Dr. Roberts found that the patient did not appear to have esophageal strictures before she had the surgery. The hospital nursing notes suggest that constipation may have been a problem because of the laxatives given during the days preceding surgery. No ulcer was found demonstrated by Dr. Roberts, only inflammation of the pyloris as a result of the endoscopy. Dr. Roberts likewise felt no fundoplicatio was justified by the patient records in this case. Dr. Woodward, Respondent's expert, likewise indicated that the history reflected in the hospital chart was characteristic of the "gas bloat syndrome." He strongly suspected that the first anti-refluxoperation (fundoplasty) was satisfactory and that she did not need any further surgery. Like Drs. Williams and Roberts, he did not think that Mrs. Smith had an ulcer either. He felt the ulcer surgery and the concomitant taking down and replacing of the previously done fundoplasty was not necessary, but did not feel he had sufficient information to opine concerning whether malpractice existed. Dr. Skinner believed the operation to be appropriate under the circumstances. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Linda Turner is a 32-year-old female with a long history of medical complaints. Seven years prior to the subject admission, she had had an ovarian carcinoma which led to a hysterectomy, bilateral salplngo-oophorectomy and appendectomy. She had multiple abdominal complaints after that and was said to have ulcerative cholitis, which causes cramping and mucous in the stool. In November 1981, she was admitted with abdominal pain and was labeled as having a recurrent ulcer and right hip pain. She was admitted by Dr. Kahn from the emergency room. Her two primary complaints were sharp pain in the right hip and numbness in the leg and increased pain on hip movement, which had nothing to do with abdominal pain. She had three weeks of cramping and abdominal pain, which gradually increased with nausea and anorexia, epigastric burning with indigestion, associated with ingestion of food and liquids. She exhibited dark brown vomit on occasion, with lower abdominal tenderness. Her hemoglobin, chest X-ray, upper GI series and small bowel X-ray series was normal, as were pictures of the stomach. The barium enema she received was normal, as were her gall bladder tests, and CAT scan and PH reflux test. Dr. Elkadi was consulted, and he said that she had upper abdominal pain, nausea and vomiting for two years, which had worsened in the last three weeks. He stated that she had occasional regurgitation and dysphagia at the base of the neck. She was said to have had one tarry black stool before her admission, but Dr. Williams doubted there was any bleeding because her hemoglobin test was normal, and no positive stool was documented for blood. The doctor's notes indicated left lower quadrant pain and some stomach cramps. The pain increased with ingestion of food. She had an endoscopy on the 9th, which resulted in a normal biopsy. On one of the biopsy specimens, there was a small amount of blood under the mucosa, but this might be explained, according to Dr. Williams, by vomiting or trauma caused by the instrumentation itself during the endoscopy procedure. He saw no other evidence to indicate she had any bleeding from the esophagus. The patient had surgery on the 19th, and the operative record indicates that extensive adhesions were found in the lower abdomen. She also had a Nissen fundoplasty and a highly selective vagotomy. The vagotomy and the fundoplasty were unnecessary. The patient's primary problem was likely the abdominal adhesions which could explain the pain and cramps in the area of the lower intestine. The patient did have some symptoms that were suggestive of esophagitis in that, when she vomited, she had epigastric distress, but Dr. Williams could see no evidence of ulcer disease in her records and chart. Dr. Williams also was of the opinion that, although the lady had a record of having three tarry black stools, the fact that her hemoglobin had not changed and that no bleeding had been demonstrated after she was in the hospital, nor was any ulcer found, that the dark stools were evidently due to some other reason than bleeding. Although the endoscopy and related biopsy showed intramucosal bleeding, that was of a very slight nature and was likely due to the trauma of the instrumentation or the trauma of vomiting. There was no ulceration and no acute inflammation of the esophageal area. There was no evidence of significant hemorrhage originating in that area. Dr. Williams then opined that the patient's written records only justified an abdominal exploration. He felt that Dr. Elkadi should have stopped with the lysis of abdominal adhesions as a means of alleviating the patient's abdominal pain and cramps related to the small intestine, rather than proceeding with the fundoplasty and vagotomy in the gastroesophageal area, where there was no concrete evidence of esophagitis, ulceration or other disease. In short, the treatment given the patient was unnecessary and fell below the acceptable standards of similar physicians under similar circumstances. He exposed the patient to additional morbidity and a slight additional risk of mortality. Dr. Roberts essentially agreed with Dr. Williams' findings and stated that, other than Dr. Elkadi's own description about the endoscopy on these written records, no evidence or history suggestive of esophagitis was shown in this patient. He stated that, although the patient complained of chronic abdominal pain for three weeks, with nausea and loss of appetite, as well as epigastric "burning," he felt these were not sufficient enough to suggest chronic esophageal reflux disease indicative of a fundoplication. He opined that, on the basis of the tests done in this case, that a diagnosis of specifically what was causing the cramps, abdominal pain, nausea and loss of appetite and upper gastric burning could not be done and certainly not sufficient to support a decision to perform the surgery that was performed. The record was simply bare of any concrete evidence to suggest esophagitis being present, and he, too, felt that the treatment of this patient by the unnecessary surgery performed, fell below standards generally required of physicians under similar circumstances. Dr. Woodward, the Respondent's expert, was of the opinion that the patient's hospital chart did not support the operation and that the patient's history was not suggestive of the presence of esophagitis. He also found that the endoscopy, while being said to show esophagitis, also resulted in a normal biopsy, thus hemorrhage present was likely induced by the biopsy forceps, since you do not typically see hemorrhage caused by esophagitis, rather you see inflammation. Dr. Woodward did not think the patient had ever had esophagitis and did not think she needed the reflux preventative operation. Thus, he felt the procedures performed were unnecessary, although he would not actually state he had sufficient information to call this type and level of treatment malpractice. Once again, Dr. Skinner believed the treatment and operation to be appropriate. The opinion of Dr. Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Felix Williams was a 62-year-old black male who was admitted in August 1981 to the service of Dr. Kahn. At that time he had a three-week history of epigastric pain with radiation to the back. Mr. Williams had a long medical history of multiple hospital admissions and surgeries. He had previously had a vagotomy and a pyloroplasty, supposedly for duodenal ulcers, which may have been unnecessary. He also had a "Bilroth II" subtotal gasrectomy, or partial removal of the stomach and reattachment of the lower intestine, designed to better drain bile from the stomach. The patient had been taking Tagamet for two to three years before the August 1981 admission. The past surgeries did not relieve the patient's symptoms. He also had had a long history of pancreatitis, with recurring abdominal pain. He had been operated on many times with no relief and continued to have the chronic pancreatitis, related to a long history of alcoholism. After being admitted on August 1, 1981, with a history of abdominal pain, the patient's serum amylase tested as being elevated. Urine amylase was also elevated. The amylase readings were only a little above normal, however, and it is common in people who have had chronic pancreatitis for years to have only a minimal elevation of their amylase when having an acute flare-up of pancreatitis. This is because the pancreas, over the years, has pretty much destroyed itself, according to Dr. Williams. The patient's upper GI series X-rays showed hiatal hernia with some reflux, but no stricture demonstrated. Ultrasound tests of the gall bladder and pancreas showed them as being essentially normal. CAT scans of the abdomen on August 27, compared to previous CAT scans, showed less enlargement of the pancreas, although it was still enlarged, which was consistent with pancreatitis. On August 31, an endoscopy was performed by Dr. Elkadi which showed a hiatal hernia and some esophagitis, as well as some alkaline gastritis and alkaline esophagitis. The biopsy done by the pathologist showed benign gastric mucosa, and the patient had no strictures of the esophagus. Bile studies showed no calcium bilirubinate crystals. In September 1981, during this same admission, Dr. Elkadi performed a cholecystectomy, or removal of the gall bladder, because of chronic cholecystis. He also performed a Roux-en-y revision of the original surgery. That is, he converted the Bilroth II surgical procedure to a Roux-en-y and also did a fundoplasty. Dr. Williams did not feel the patient needed surgery at all, but rather his symptoms were due to chronic pancreatitis. He felt that if the person was going to be operated on, however, that the removal of the gall bladder was certainly indicated, and that this is one of the causes of pancreatitis. In this case, the man had a long history of alcoholism, which serves to cause pancreatitis which, once it gets started, tends to be self- perpetuating. Dr. Williams felt that any surgery done at this point with the patient would result in the same problem, that is not alleviating the pancreatitis and associated abdominal pain. Dr. Elkadi knew of the pancreatitis or should be presumed to have known because the CAT scan taken on August 27, 1981, as well as the amyfase test results, revealed pancreatitis. He did not strongly consider pancreatitis as the primary problem, however, and, according to his notes, thought that repairing the reflux condition he believed to exist would take care of the problem. The Roux-en-y surgical procedure, as well as the fundoplasty, however, would not address the primary problem of pancreatitis, so the abdominal pain would still continue, which in fact it proved to do after Mr. Williams recovered from surgery. The pancreatitis-induced vomiting will not occur as much after the fundoplasty because that procedure prevents vomiting, but the patient will still have the same morbidity; it will just be manifested in a different way. The opinion of Dr. Williams establishes that the gastroesophageal reflux, which was seen on the endoscopy, in reality was due to the pancreatitis, and that the fundoplasty which was performed would do nothing to alleviate the pancreatitis. It might make it be manifested somewhat differently by reducing vomiting, but the abdominal pain and elevated amylase characteristic of the pancreatitis were still there. In summary, Dr. Williams felt that the removal of the gall bladder was justified and that the Roux-en-y procedure, which is designed to move bile juices from the stomach, would be justified, but for the fact that the primary problem was pancreatitis, which surgery of that type will not correct. Dr. Williams did not feel that the Respondent misdiagnosed pancreatitis, but just that he was "overly optimistic" and should have appreciated the fact that surgical treatment of this type would not have helped the man and that the only surgical treatment for chronic pancreatitis is removal of the pancreas, which causes a severe morbidity problem in and of itself and would probably not be indicated either. Thus, Dr. Williams opined that Dr. Elkadi's treatment of Felix Williams fell below accepted standards of physicians practicing under similar circumstances and conditions. Dr. Roberts also felt that the patient's basic problem was pancreatitis, relying on the same records that Dr. Williams relied on in his testimony. The patient had epigastric pain radiating through to the back, which is a classic indication of pancreatitis, which, when coupled with elevated serum amylase, establishes the presence of acute pancreatitis. Dr. Roberts was unable to find any history of nausea or vomiting, which would suggest gastric esophageal reflux, the admitting diagnosis being simply abdominal pain and pancreatitis. Since the patient had pancreatitis, that condition is consistent with the slowness of the stomach to empty itself, which in itself could have permitted reflux with changes consistent in the esophagus with esophagitis. Dr. Roberts was of the opinion that the records did not show the necessary symptomology to justify the anti-reflux surgery which was done. He thus felt that the standards of care of a reasonable, prudent physician under similar conditions and circumstances had not been met by the Respondent. The Respondent's expert, Dr. Woodward, after reviewing the records of Felix Williams, also felt that the symptoms did not suggest reflux esophagitis, the indication for the fundoplication surgery. Dr. Woodward did not, in his testimony, discuss the fundoplication procedure specifically. Dr. Woodward opined that the symptoms did not suggest reflux esophagitis, although this was diagnosed by the endoscopy, which was performed by the Respondent himself. He also did not feel the biopsy report was very convincing and felt that "the pathologist was trying to help out the surgeon." Nevertheless, Dr. Woodward felt that there was no doubt about his having reflux alkaline gastritis, which Dr. Williams noted as well, and felt that this was due to the unnecessary surgeries already performed by past surgeons. Dr. Woodward noted that this was also associated with marked gastric retention or failure of the stomach to empty rapidly enough. He thus felt that the patient should have another operation, if nothing else, to try to get the stomach to empty better and to divert some of the duodenal fluid away and hopefully give him some degree of pain relief. This surgery was done in the form of the Roux-en-y procedure performed by the Respondent. Neither Dr. Williams nor Dr. Woodward felt that this surgery was improperly performed. Dr. Williams merely felt that it was probably unnecessary, since the root problem was pancreatitis. However, Dr. Woodward established that, at least in an effort to aid stomach emptying and avoid gastric pain associated with bile retention in the stomach, that the Roux-en-y procedure probably was necessary. None of the three doctors opined that the fundoplication was necessary, however, since reflux esophagitis was not present. In summary, it is found that the surgeries performed, consisting of the cholecystectomy and the Roux-en-y procedure were appropriately done under the circumstances, although this is a marginal case for such surgeries being indicated, based upon the totality of the expert testimony, because of the underlying problem of pancreatitis. In any event, however, the fundoplication which was done was shown to be unnecessary and not medically indicated. Thus, as to that procedure, the Respondent's practice with regard to this patient fell below the medical practice standards referenced above.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners suspending the Respondent's license for a period of one year, with reinstatement to active status contingent on Respondent making satisfactory showing, by completing continuing education courses, or in such manner as the Board may elect, that he has worked diligently to enhance his knowledge and skill in the area of gastroenterological surgery, including the "indications" for such. It is further recommended that the Respondent's license be placed in probationary status for two years thereafter, with such terms and conditions as the Board deems appropriate, within the guidelines of Rule 2lM-20.001(t), Florida Administrative Code. The failure to comply with any such terms and conditions should result in revocation. DONE and ORDERED this 27th day of December, 1988, In Tallahassee, Florida. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 FILED with the Clerk of the Division of Administrative Hearings this 28th day of December 1988. APPENDIX TO RECOMMENDED ORDER CASE NOS. 86-1140 & 86-1327 Petitioner's Proposed Findings of Fact: 1. Accepted. 2-3. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 6-17. Accepted. 18-20. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23-25. Accepted. 26. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 27-29. Accepted. 30. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #1. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #2. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 36 #1. Accepted. 36 #2. Accepted. 37-40. Accepted. 41. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 42-44. Accepted. 45. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Respondent's Proposed Findings of Fact: 13-20. Accepted, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 21-22. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23. Rejected as not being of probative material import. 24-25. Rejected as to its purported material import. 26-29. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as to its purported material import. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 33-34. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 37-39. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 42-43. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not as to its purported material import. 46-47. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 48. Accepted. 49-53. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 54-56. Rejected as to its purported material import. 57. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 58-61. Accented. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 64-65. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. Rejected as not being of probative material import. 68-69. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 74-77. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 83-84. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 85-86. Accepted. 87-89. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 90-91. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not in itself dispositive of any material Issue. 94-95. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 98-99. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 100. Rejected as to its purported material import. 101-102. Rejected as subordinate to the - Hearing Officer's Findings of Fact on this subject matter. 103-104. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 105-107. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not in accordance with clear and convincing evidence. Rejected as not being of probative material Import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not to the extent that the fundoplication was indicated. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter, as not being of probative material import and as constituting argument of counsel. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence, was subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not being of probative material import. 117-119. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 120. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not of material import in itself. 121-122. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not in itself dispositive of material issues. 123-127. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 128-130. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 131-132. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 133-142. Really amount to legal argument and recitation of testimony and evidence regarding the Motion to Dismiss, which has been dealt with supra. COPIES FURNISHED: Roosevelt Randolph, Esquire KNOWLES & RANDOLPH 528 East Park Avenue Tallahassee, Florida 32301 Spiro T. Kypreos, Esquire LEVIN, MIDDLEBROOKS, MABIE, THOMAS, MAYES & MITCHELL, P.A. 226 South Palafox Place Post OffIce Box 12308 Pensacola, Florida 32581 Harry Rein, Esquire 3803 Lake Sarah Drive Orlando, Florida 32804 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether Angel Balbuena, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Preliminary findings Antonio Balbuena is the natural father of Angel Balbuena (Angel), a minor, and Juan Carlos Donado and Antonio Balbuena are co-guardians of Rosa Donado, the natural mother of Angel. Angel was born a live infant on February 5, 2001, at Palmetto General Hospital, a hospital located in Dade County, Florida, and his birth weight exceeded 2,500 grams. The physicians providing obstetrical services at Angel's birth were Richard Friefeld, M.D., and Jose Abreu, M.D., who, at all times material hereto, were "participating physician[s]" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Angel's birth At or about 3:30 p.m., February 4, 2001, Ms. Donado presented to Palmetto General Hospital, for induction of labor. Ms. Donado received cervidil overnight and IV hydration, and the baby's tracing was noted as reactive. At approximately 6:33 a.m., February 5, 2001, Ms. Donado's membranes spontaneously ruptured. Shortly thereafter, Ms. Donado "complained she couldn't breathe and proceeded to have seizure-like movements;" at approximately 6:40 a.m., full code was called for cardiopulmonary arrest; and at 6:59 a.m., Angel was delivered by stat cesarean section. At delivery, Angel was depressed (limp, with no tone, spontaneous movement, or respirations), and was immediately given oxygen by bag and mask, with improvement in color and heart rate over 100 beats per minute, and then intubated. Apgar scores were recorded as 4, 5, and 5, at one, five, and ten minutes, respectively,3 and cord pH was recorded at 6.66. Following resuscitation, Angel was transported to the neonatal intensive care unit (NICU), where he was admitted at approximately 7:30 a.m. The Neonatal Admission History and Physical provided, in part, as follows: Maternal History . . . . Mother is 43 y/o . . . who received pre- natal care by Dr. Freifeld. Pregnancy complicated by Gestational diabetes Diet controlled. Mother also had Amnio for AMA [Advanced Maternal Age] of 43 which showed 46XY. No other problems or complications. Delivery low trans. Cesarean section . . . . Resuscitation: mask vent, ET tube, med. volume Maria Oliver, M.D. [a neonatologist] was called to the delivery room because of Maternal cardio-respiratory arrest. Delivery analgesia used: general- intubation. Suctioning at delivery: bulb. The respiratory effort at birth was delayed. Delivery outcome: live birth admitted to ICN. Cord Venous Gases: VEN pH=6.66 pCO2=184 p02=5 BE=-16.5 Called stat to attend an emergent primary C/S due to maternal Cardio-Respiratory arrest, for a presumptive Dx. of Amniotic fluid embolism. Mother came to Palmetto on 02/04/01 for Cervidil induction for 40wk preg. Mother received Cervidil overnight and IV hydration, the baby's tracing was reactive, at approx. 6:33am mother had spontaneous ROM and by nursisng [sic] and father's account immediately complained that she couldn't breath [sic] and proceded [sic] to have seizure like movements at 6:40 am full code was initiated and baby was delivered at 6:59 am. Baby was born via stat c/s w/triple nuchal cord around neck, limp, no tone or spontaneous movements or respirations, immediate bag and mask initiated w/improvement in color HR>100, and chest movement, immediately intubated, w/excellent chest exclusion, NO spontaneous movements, NO spontaneous respirations, NO grimance [sic] or reflex. Baby received 20cc/KG of Lactated ringers as volume expander, followed by 2meq/kg of NaBicarb9 presumed weight of 3kg. Baby's color improved to pink from pale/ash, good pulses, HR>100, excellent chest mevements [sic] and breath sounds w/bagging, was transported to NICU in pre-heated isollete, for further stabilization and diagnostic w/u. The umbilical cord appeared mec. stained though no mec. was noted at time of rupture of membranes. ADMISSION HISTORY: Baby was briefly placed on high-frequency vent, but HR began to drop and responded to convetional [sic] vent well, no seizures noted . . . . At about 1 hr of life baby started to grimace w/light stimuli and prior to second hour of life opened eyes spontaneouly [sic] briefly, there is sucking movement, and upper extremety [sic] movement . . . . Examination . . . . GENERAL: hypotonic, distressed, pale pink SKIN: pale, pink HEAD: open, anterior fontanelle EYES: initially fixed and dilated, but at about 2 hrs became reactive to light . . . . LUNGS & CHEST: paradoxical respirations, on conv. ventilation CARDIAC: normal rate and rhythm, no murmur * * * LIMBS & HIPS: upper extrem showing some movement, lower still poor movement NEUROLOGIC: hypotonic, s/p severe perinatal stress, and metabolic acidosis low APGARS, starting to respond to light stimuli . . . . Assessments & Plans ASSESSMENT: Term male, severe perinatal stress, low APGAR's, severe metabolic acidosis, Nuchal cord X3, R/O sepsis, MaternalCardio-resp. arrest. Possible maternal amniotic fluid embolism. ADMIT DIAGNOSES: Perinatal depression (admit), maternal cardio-resp arrest. Respiratory distress (admit). Term infant (admit). Metabolic acidosis. Suspected sepsis (admit) . . . . ADMIT PLAN: . . . Neurology (Dr. Bustamante) consult, EEG Dopamine drip, Na.bicarb to correct MA. Following admission to NICU, Angel had an electroencephalogram (EEG) to evaluate for seizure activity. That study was read as abnormal, with the following impression: MARKEDLY ABNORMAL STUDY. DYSRRHYTHMIA GRADE 3, SUBCONTINOUS ELECTROGRAPHIC SEIZURES CORRELATING WITH SUBCONTINUOUS BIFRONTAL EPILEPTIFORM ACTIVITY (LEFT GREATER THAN RIGHT) SUPERIMPOSED ON A SUPPRESSION GRADE 2 PATTERN. CLINICAL CORRELATION IS ADVISED AND A FOLLOW UP STUDY IS SUGGESTED. Angel also had a head ultrasound to evaluate for intracranial abnormalities. That ultrasound was read as follows: The study shows normal visualization of the ventricular system and corpus callosum as well as of the germinal matrix without evidence of abnormality to suggest the presence of subependymal or intraventricular bleed. IMPRESSION: NORMAL ULTRASOUND OF THE INFANT HEAD. At 11:50 p.m., February 5, 2001, Martha Bustamante, M.D., a pediatric neurologist, examined Angel at the request of Dr. Oliver. Following evaluation, Dr. Bustamante recorded her assessment and plan (A/P) as follows: . . . s/p severe perinatal asphyxia, required prolonged & vigorous resuscitation, nuchal cord x 3 [with] meconium stained amniotic fluid. Severe metabolic acidosis . . . . Status Epilepticus - [continue] anticonvulsant med[ication] phenobarb . . . will get [followup] EEG in 48 [hours] . . . . Suspect multiorgan involvement. Already [decreased] urine output [with increased] Bun, Creat . . . . Continue hyperventilation/supportive care. guarded prognosis On February 6, 2001, Dr. Bustamante recorded the results of a 10:15 p.m., examination as follows: No further [seizures] since last night. No active bleeding. Neuro exam - no continuous obligate asymmetric tonic neck reflex but still [with] head/neck preferences to [left]. [Positive for] asymmetrical U[pper] E[xtremity]'s limb move[ment] noted at rest and [decreased] move's [with] R[ight] U[pper] E[xtremity]. [Positive for] cortical thumbs and diffuse hypertonia . . . Continue close observation over renal output/Bun, Creat. . . [Followup] EEG tomorrow. A/P - Showing improving neuro status following severe hypoxic-schemic insult. Continue aggressive supportive care. Get P[hysical] T[herapy]/O[ccupational] T[herapy] input . . . and S[peech] T[herapy] in future. On February 7, 2001, Angel extubated himself, was placed on an oxyhood for a brief period, and then transitioned to room air. Followup EEG on February 7, 2001, was read as abnormal, with the following impression: ABNORMAL STUDY DUE TO THE PRESENCE OF INTER- ICTAL MULTIFOCAL EPILEPTIFORM ACTIVITY. THIS STUDY IS CLASSIFIED AS A DYSRHYTHMIA GRADE II/MULTIFOCAL. THIS FOLLOW UP STUDY SHOWS MARKED IMPROVEMENT WHEN COMPARED TO THE PRIOR STUDY OF 2/5/01. CLINICAL CORRELATION IS ADVISED. Dr. Bustamante recorded the results of her neurologic examination of February 7, 2001, as follows: . . . No further [seizures] [Followup] EEG = multifocal spikes[,] phenobarb level 22[.] [Patient] extubated himself and breathing on his own. Neuro-Obtunded [with] intermittent hypervigilant state c[onsistent]/w[ith] H[ypoxic] I[schemic] E[ncephalopathy]. [Increased] tone in all limbs, profound head lag. [Positive for] diffuse hyper-reflexia. Facial dipligia [with] gaging [with] poor suck on own secretions suggestive of dysphagia. [Upgoing] plantars. Fisted hands. Over the next two days, Angel showed improved neurologic status, and on February 9, 2001, the following NICU Progress Note was entered: Interim events: Angel remains extubated, stable in room air, no A's and B's, responds w/eye movement, and upper extrem movement to voice, light and touch stimuli, lower extremities not hypertonic, NO gag, NO cry, No seizures on Phenobarb, all other organ systems stable, excellent urine output, will start minimal feeds today. Angel's neurologic progress continued to show improvement, and on February 12, 2001, the following entry appeared in the NICU Progress Note: EXAM: responsive to touch, and voice, attempting moving upper extremities, (+)eye opening, gag reflex present. GENERAL: quiet, hypotonic HEENT: open, anterior fontanelle normal shape and size, equal red reflexes, equally reactive pupils normally set, no anomalies patent nares, intact palate. RESPIRATORY: symmetric chest, no distress, clear and equal breath sounds supple neck, intact clavicles. CARDIAC: normal rate and rhythm, no murmur. ABDOMEN: 3 vessel cord. NEUROLOGIC: weak, discoordinated suck, hypotonic . . . . EXTREMITIES: 10 fingers and toes, stable hips, symmetric, moves all 4, straight spine . . . . Since Angel had been seizure-free since February 5, 2001, phenobarbitrol was discontinued pending the results of a "cat scan/mri." The brain CT was done February 12, 2001, and read as normal. Dr. Bustamante reported the results of her February 16, 2001, neurologic examination as follows: H[ead] C[ircumference] 34 cm [up] 1 cm from birth. Last [seizures] 2/5/01. Feeding better since 2/15/01. Plain brain CT 2/12/01 reported as (-). Receiving OT/ST/PT . . . . Neuro . . . . MS: lethargic [with decreased] alertness & responsiveness. [Positive for] weak cry. [Positive for] fairly good suck. CN: not visually fixating. [Positive for] roving-like move's, not tracking . . . [decreased] facial tone/expression [with] subtle [right] facial droop. Motor: [decreased] tone in axial & upper ext[remities] musculature. [Increased] tone in L[ower] E[xtremities]. [Positive for] intermittent asymmetrical posturing/moves [with] R[ight] U[pper] E[xtremity] in ext./ L[eft] U[pper] E[xtremity] in flexion, R[ight] L[ower] E[xtremity] in ext & LLE in flex suggestive of R>L weakness, hyper- reflexia diffusely but no clonus. Sensory: Withdrawals fairly symmetrically to painful/tactile stimuli. A/P Hypoxic Ischemic Encephalopathy. Off phenabarb since 2/12 and no [seizure] recurrence since last [seizure] on 2/5/01. While in house continue supportive care and current therapy . . . . [Patient] will need out pt. rehab. PT/OT + ST. Angel was discharged from Palmetto General Hospital on February 19, 2001, and his Neonatal Discharge Summary4 noted the following discharge exam and discharge plan: Discharge Exam . . . . GENERAL: alert and active, pink and well perfused * * * LUNGS & CHEST: no distress, clear and equal breath sounds CARDIAC: normal rate and rhythm, no murmurs, good femoral pulses * * * LIMBS & HIPS: moves all 4 limbs, stable hips NEUROLOGIC: normal suck, symmetric Moro, decreased strength and tone Discharge Plans The follow up provider at discharge was unknown. The parents were instructed to call for an appointment in 1 week. A home health referral was made. Additional appointments: Developmental clinic, neurology f/u opp[,] infant referred for developmental follow-up testing . . . . Angel's subsequent development Following discharge from Palmetto General Hospital, Angel was referred for follow-up to Celadie Fiallo, Jr., M.D., a pediatrician practicing as Pediatrics-R-Us, P.A., and the University of Miami School of Medicine Early Intervention Program. In so far as the record reveals, Angel was seen on two occasions at the Early Intervention Program: on March 27, 2001, and October 17, 2001. Angel's visit of March 27, 2001, was reported as follows: Medical Assessment: Angel was referred by Palmetto hospital because of perinatal asphyxia and neonatal seizures . . . . Angel has been doing well since discharge from the hospital . . . . Physical exam is remarkable for hypertonia of back muscles and lower extremities. He can lift his head in the prone position and visually track an object . . . . His vision appears normal. He passed hearing today. * * * Recommendations: Based on the above results and on observations of Angel's behavior during the evaluation today it is recommended that: Continue follow up with pediatrician. Refer for physical therapy 2 times per week for hypertonia . . . . Angel's visit of October 17, 2001, was reported as follows: Medical Assessment: Developmentally, he rolls over both ways and bubbles. Angel has good appetite, eats baby food and some solid foods and drinks milk from the bottle. Physical exam is remarkable for left esotropia. Neuromuscular exam shows increased muscle tone in all extremities. He tends to keep his hand[s] fisted but will open them to reach. Mild shoulder retractions. DTR's are brisk. Absent left lateral protective reflex. Right is present as well as parachute. Vision appears normal and he passed hearing test on 3/27/01. Developmental Assessment: Tests Administered: Bayley Scales of Infant Development/Developmental Profile (DPIYC) * * * Bayley: The Bayley Scale resulted in a Mental Development score within the average range, developmental equivalent of 7 months; and Motor Development score within the delayed range, developmental equivalent of 6 months. DPIYC Test Results: Cognitive (8 months): Angel can attain a completely hidden object. Communication: (7 months): Angel can localize sound source. Fine Motor (8 months): Angel can scoop a pellet. Gross Motor (6 months): Angel can roll from back to stomach. Social: (8 months): Angel can reach for image of self in mirror. Adaptive (7 months): Angel can drink from cup with help. * * * Recommendations/Referrals: Based on the above results and on observations of Angel's behavior during the evaluation today it is recommended that: Physical therapy to assist with his gross motor skills. Continue follow up with pediatrics . . . . Angel was initially seen by his pediatrician, Dr. Fiallo on March 12, 2001. By October 2001, Dr. Fiallo had referred Angel for a physical therapy evaluation to address a perceived delay in motor development. That evaluation concluded Angel evidenced mild generalized hypertonia, with a gross motor development level at 7 months, and recommended physical therapy twice a week. Dr. Fiallo concurred with this evaluation and certified the need for physical therapy (2 times a week for 6 months) to Medicaid, with a rehabilitation potential of "good," as opposed to "fair" or "poor." Subsequently, on November 5, 2001, Angel's guardian reported evidence of possible seizure activity, and Dr. Fiallo referred Angel for an EEG and an MRI of the brain. Angel's guardian did not keep the appointment for the EEG, but the MRI was done at Miami Children's Hospital on November 9, 2001, and reported as follows: HISTORY: Nine month old evaluated for seizures and developmental delay. * * * FINDINGS: The ventricles are normal in size and position. The white matter myelin pattern is very incomplete. There is symmetric hypomyelination in the biparietal periventricular white matter extending into the corona radiata on the T2 weighted studies. It appears slightly more pronounced than physiologic terminal zones. The remainder of the myelin pattern is unremarkable for age. There are no abnormal sites of contrast enhancement. There is no significant structural brain anomaly apparent. CONCLUSION: There is hypomyelination in the biparietal white matter which appears more pronounced than physiologic terminal zones. In view of the history of developmental delay and seizures, follow-up MR is recommended to reassess the myelination and verify appropriate maturation of the brain. Clinical correlation is also recommended to evaluate whether the patient has a static or progressive encephalopathy. Thereafter, the EEG was rescheduled for July 17, 2002, at Miami Children's Hospital. That appointment was kept, and the EEG was reported as follows: IMPRESSION: Abnormal EEG study obtained in the awake, drowsy and sleep states because of the multifocal epileptiform discharges and the asymmetric background. These findings indicate a multifocal cerebral dysfunction left more than right which is potentially epileptogenic. Following the results of the EEG, Dr. Fiallo referred Angel to Miami Children's Hospital for evaluation by Michael Duchowny, M.D., then Director, EEG Laboratories and Seizure Unit, Miami Children's Hospital, and Clinical Professor in Pediatric Neurology, University of Miami School of Medicine. That evaluation, done on January 21, 2003, was reported as follows: Angel is a 1 year, 11 month old male with developmental delay and history of episodes of crying and shaking during sleep . . . . An EEG was done on 07/17/02, which demonstrated multifocal epileptiform discharges indicating multifocal cerebral dysfunction greater on the left side than the right side. MRI of the brain was done on 11/09/01 and demonstrated biparietal white matter hypomyelination He gets physical therapy, but no speech therapy at this time. Developmentally he has been delayed and walked at 19 months. A review of Angel's PRE and PERINATAL HISTORY shows him to be the product of a pregnancy without complications. He was born at term after spontaneous rupture of membrane. Labor was complicated by maternal cardiopulmonary arrest, which was followed by emergency caesarean section. He had respiratory distress at birth and was intubated for seven [sic] days. He spent 15 days in the Palmetto Hospital Neonatal Intensive Care Unit. His birth weight was 7-pounds, 3-ounces. There were no other neonatal complications according to his foster mother. * * * REVIEW OF SYSTEMS: Restless sleep as described above. He has no history of cardiac, lung, GI, or GU disorders. His foster mother notices that his muscles are "tense." PHYSICAL EXAMINATION shows him to be alert and in no acute distress. Weight is 25 pounds, 1-ounces. Head circumference is 46.5 cm, which places him at about the 25th percentile. There are no dysmorphic features or neurocutaneous manifestations. His tonsils are 1+bilaterally. Abdoment is soft with no organomegaly. Spine and extremities are normal. He transfers, and has bilateral parachuting responses. NEUROLOGIC EXAMINATION: His mental status is attentive. He follows commands very well, but has minimal speech production. He mostly makes unintelligible sounds. Cranial nerves II through XII are intact. Fundi show no apparent retinopathy. Motor examination reveals normal bulk, tone, and strength and use of all four extremities. He has minor decrease in fine motor ability in both upper extremities. The deep tendon reflexes are 3+ throughout and brisk, with no clonus and symmetrical. Plantar responses are flexor bilaterally. On cerebellar coordination, there is no tremor or abnormal movements. His gait is somewhat wobbly and he falls frequently if not assisted. IMPRESSION: 1) Global developmental delay. 2) Speech delay. 3) Paroxysmal nocturnal motor events, questionable for seizures. 4) Oromotor apraxia. 5) Snoring. 6) Abnormal EEG and MRI. PLAN: 1) Would be beneficial to see the nocturnal events and his foster mother states that she will attempt to video these events and bring us an example. 2) Occupational and speech therapies in addition to physical therapy . . . . Coverage under the Plan Pertinent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation . . . occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat. In this case, Petitioners are of the view that during the course of labor, delivery, or resuscitation, Angel suffered an injury to the brain caused by oxygen deprivation, secondary to his mother's cardiopulmonary arrest, that rendered him permanently and substantially mentally and physically impaired. In contrast, NICA is of the view that, while Angel's mother suffered a cardiopulmonary arrest, the proof fails to support the conclusion that any oxygen deprivation Angel may have suffered was sufficient to produce brain injury, and that his impairments were, more likely than not, related to prenatal (developmental) events. Moreover, NICA is of the view that regardless of the etiology of Angel's developmental delay, he is not permanently and substantially mentally and physically impaired. The cause and timing, as well as the significance of Angel's impairment To address the cause and timing of Angel's impairment, as well as its significance, the parties offered certain records related to Angel's birth and subsequent development, portions of which have been addressed supra and portions of which will be addressed infra (Petitioners' Exhibits 1A-1E and 2, and Respondent's Exhibits A-C and E); the deposition of Steven Abern, M.D., a physician board-certified in pediatrics, and neurology with special competence in child neurology (Petitioners' Exhibit 3); the deposition of Michael Duchowny, M.D., a physician board-certified in pediatrics, neurology with special competence in child neurology, and clinical neurophysiology (Respondent's Exhibit F); and an affidavit of Dr. Duchowny (Respondent's Exhibit D). Dr. Abern, whose deposition was offered on behalf of Petitioners, was of the opinion, based on his review of the medical records and his neurologic evaluation of Angel on January 20, 2003,5 that Angel was permanently and substantially mentally and physically impaired, and that, more likely than not, his impairment resulted from a brain injury caused by oxygen deprivation that occurred during labor, delivery, or resuscitation. Dr. Abern described the results of his examination as follows: . . . Approximately two-year old right [handed] Hispanic male . . . . In therapy for not walking, walks unsteady. No language, just babbles Has appointment with neuro[logist Dr. Duchowny] tomorrow . . . . 7/02 abnormal EEG. [M]ultifocal epileptiform discharges left greater than right as well as continuous slow left hemisphere. In therapy two times a week for 45 minutes for two months. short thumbs, slobbers a lot, no regression . . . . Toddler walk, wide based . . . . No concerns with hearing or vision . . . . [F]unctioning at approximately one-year level . . . . Rudimentary pincer . . . . (Petitioners' Exhibit 3, pages 49-51) Notably, Dr. Abern characterized the results of his examination as consistent with the results of Dr. Duchowny's examination of January 21, 2003, in that he observed, as did Dr. Duchowny, "normal tone, normal strength, no tremor or abnormal movements. His gait is somewhat wobbly, and he falls frequently if not assisted." (Petitioners' Exhibit 3, page 54) With regard to the etiology of Angel's impairment, Dr. Abern was of the opinion that Angel's impairments were the "sequela" of a "profound hypoxic ischemic insult at the time of birth secondary to his mother's cardiopulmonary arrest." (Petitioners' Exhibit 3, page 24) In so concluding, Dr. Abern noted Angel's severe depression at birth; the presence of a triple nuchal cord around the neck; the need for prolonged resuscitation; a cord blood pH consistent with severe acidosis; evidence of seizure activity within the first few hours of life; evidence of multiple organ abnormalities; and the need for medication (Dopamine) to maintain blood pressure. Dr. Abern was also of the opinion that the MRI scan of November 9, 2001, revealed brain injury, consistent with a hypoxic ischemic insult at birth. Dr. Abern explained his reasoning as follows: Q. It is your opinion that the MRI for Angel Balbuena done on November 9, 2001, is consistent with Angel having experienced an hypoxic insult during labor and delivery? A. Yes, it is. Q. How so? A. How so, because if you read the report where there is the -- there is symmetric, and he uses the words hypomyelination, in the biparietal periventricular white matter extended into the corona radiata on a T2 weighted studies. It appears slightly more pronounced than physiologic internal zones. I would call it a periventricular leukodystrophy because where these leucines that he's calling the hypomyelination is in the watershed areas which is where you would expect a child who has no blood pressure and lack of oxygen or decreased blood flow to have the damage which is exactly where you see it. (Petitioners' Exhibit 3, pages 33 and 34) In weighing Dr. Abern's opinion regarding the significance of Angel's impairment, the following observations by Dr. Abern are worthy of note: Q. Is it your opinion that Angel Balbuena is permanently and substantially mentally impaired? A. What do you mean mentally impaired? Let's define that term. Q. How would you define an infant that is mentally impaired? A. There is [sic] lots of ways to define it. That's why I am asking. He is developmentally delayed. When I saw him, he had some motor problems. I know that he had some speech problems, but I can't tell you cognitively because I don't have enough information. * * * Q. Is it your opinion that Angel Balbuena is permanently and substantially physically impaired? A. He is physically impaired. Whether it is permanent, with his therapies he may be corrected. But right now at this point in time with the snapshot I would say, yes. Q. You would say, yes, he is permanently and substantially physically impaired? A. At this point in time. Q. Based on the records you have seen and based upon your evaluation of Angel Balbuena, do you have an opinion as to whether or not he has been improving from a physical standpoint since his birth? A. From the records that I've seen, he has improved. Q. Do you expect him to continue to improve? A. That is the hope. * * * Q. What was your impression based upon your evaluation [of January 20, 2003]? A. My impression is that he was functioning at approximately one-year developmental level. He was going to see Dr. Duchowny the next day. I was concerned that this child may be having seizures from taking the history. And that the child is developmentally motorically and language delayed. Q. You said motorically? A. Motorically. * * * Q. Based on your evaluation, what is the nature of Angel's motor delay? A. The brain damage that he had at or near the time of his birth. Q. Let me ask it another way. How is he delayed from a motor standpoint? A. He is two years old. He is just starting to walk. He doesn't have a fine motor rudimentary pincer. His developmental milestones were delayed. Q. In your opinion, based upon your evaluation, did Angel have hypotonia? A. I did not find any hypotonia. Q. What is hypotonia? A. Low tone. Q. In your opinion, based upon your evaluation, did Angel suffer any ataxia? * * * A. . . . I didn't write it down, and I don't recall. . . . I can tell you that his gait was wide based and [sic] in a toddler. Q. What's the significance of that finding? A. That he's walking and that he's a toddler gait. All children when they start to walk walk somewhat wide based. Q. So that's essentially normal? A. That's essentially normal at that point in time, correct. Q. Other than the finding that he was two years old and just starting to walk, were there any other motor deficits that you found on your evaluation? * * * A. The fine motor, the rudimentary pincer grasp. Q. Explain that, the rudimentary pincer grasp. A. You ask a child to pick up a Cheerio. They usually start with their whole hand and then they progress to the thumb and forefinger so they can pick up an individual Cheerio. His was rudimentary. Q. What do you mean by rudimentary? A. Development -- it was delayed. It was not developed as well as it should have been. Q. What other impression, if any, did you have based upon your evaluation on January 20, 2003? A. That was basically what I had. I knew he was going to see Dr. Duchowny the next day, and then Dr. Duchowny's exam basically confirms mine. It reveals normal tone, normal strength, no tremor or abnormal movements. His gait is somewhat wobbly, and he falls frequently if not assisted. (Petitioners' Exhibit 3, pages 24-26, and 51-54) As for the implications of Ms. Donado's cardiopulmonary arrest, Dr. Abern offered the following additional observations: Q. In your opinion, how long and how severe was the hypoxic insult experienced by Angel in this case? A. Angel's mother arrested around 6:45 in the morning. He was born at 6:59 in the morning. So there was approximately a 15- minute, 20-minute period of time he was compromised. * * * Q. If Angel had experienced an insult for 15 to 20 minutes during labor and delivery, would you have expected his transition from the intrauterine [environment] to the . . . . Extrauterine environment to be more difficult than what was reported in the medical records? A. No, because the child has a reserve. Q. Meaning what? A. Meaning that the placenta is still providing some of the nutrition, some of the oxygenation for him. It's not a total abrupt. He's still getting some blood flow, still getting some oxygen, and the child has their own reserve. * * * Q. So even though there may have been an infarct in the placenta as you described earlier, the affect on the child may not have been as significant given those reserves and the continual nourishment of the placenta? * * * A. It may or may not have been. I don't know what the child's reserves were. (Petitioners' Exhibit 3, pages 38, 47, and 48) Dr. Duchowny, who had examined Angel at the request of his pediatrician on January 21, 2003, conducted a follow up examination on July 16, 2003, at the request of NICA. Dr. Duchowny reported the results of his follow-up visit as follows: I reevaluated Angel Balbuena on July 16, 2003. Angel is now 2 1/2 years old . . . . As you know, Angel was previously evaluated by me on January 21, 2003. At that time he was almost two years old and presented with developmental delay and nocturnal episodes . . . . The major concern at that time focused on periodic nocturnal awakenings in which he would cry and appear to be fearful. He has also had one episode of unresponsiveness without motor accompaniments. An EEG on July 17th had revealed multifocal epileptic abnormalities. He was on no intercurrent medications. Angel's DEVELOPMENTAL MILESTONES were consistently delayed. He was not speaking at his first evaluation and had only recently begun taking steps at age 19 months. His examination confirmed his delayed speech and development. The etiology of his nocturnal motor events was not specified. Over the past six months Angel has made some limited progress. He is now speaking six or seven words and his father feels his motor abilities have improved across the board. He is still quite unstable, however, and will fall intermittently. He cannot run on his own . . . . Angel is receiving physical and speech therapy on a twice weekly basis and his caretaker supplements these exercises at home . . . . PHYSICAL EXAMINATION reveals him to be alert and cooperative. His head circumference measures 46.7 cm, which is within standard percentiles for age. His fontanels are closed. The hair is dark brown and of normal texture. He weighs 26 pounds. The neck is supple without masses, thyromegaly or adenopathy, and the cardiovascular, respiratory and abdominal examinations are unremarkable. Angel's NEUROLOGIC EXAMINATION reveals him to be sitting up and attentive. He plays with toys and uses both hands. He is quite sociable. He did not talk in words during the evaluation but he clearly communicated his needs and responded to simple commands. His cranial nerve examination reveals full visual fields to confrontation testing and normal ocular fundi. The pupils are 3 mm and are briskly reactive to direct and consensually presented light. There are no facial asymmetries. His tongue movements are poorly coordinated. There is minimal drooling. Motor examination reveals mild generalized hypotonia in a symmetric distribution. There is no focal weakness, atrophy, or fasciculations. He has good bimanual skills and individual finger movements. His deep tendon reflexes are slightly exaggerated at 3+. He can stand and bear weight and is able to walk across the room. However, his gait is somewhat unstable and there is head titubation and a wide-based stance. He has a tendency to fall in either direction. There are no specific focal or lateralizing findings. In SUMMARY, Angel's neurologic examination reveals evidence of speech delay and generalized hypotonia with ataxia. He has progressed since his previous evaluation in January. (Respondent's Exhibits D and E) Based on his neurologic evaluations and review of the medical records, Dr. Duchowny was of the opinion that: Although Angel clearly had a difficult delivery, significantly impaired cord blood gases, and an immediate need for intubation and ventalitory support, I do not believe that Angel's neurologic impairments were acquired in the course of labor and delivery. My opinion is based on the neurologic findings of generalized hypotonia and ataxia, which are more consistent with prenatally acquired cerebral palsy. His MRI performed on November 9, 2001 is consistent with this formulation as it demonstrates biparietal white matter hypomyelination, findings that are not indicative of a hypoxic ischemic insult acquired during labor or delivery. (Respondent's Exhibit E) Dr. Duchowny was also of the opinion that Angel was neither substantially mentally nor physically impaired. In his deposition testimony, offered on behalf of NICA, Dr. Duchowny elaborated on his opinions as follows: Q. What happens to an infant when the mother is having cardiopulmonary arrest? A. It depends on the severity of the arrest. Anywhere from nothing to catastrophic circumstances to the infant. Q. What was the severity of Angel's mother's cardiopulmonary arrest? A. Well, I think that -- it's not clear . . . . Q. So is it then unclear what effect the cardiopulmonary arrest of Angel's mother had on Angel? A. No, I think that was clear. I don't think it had an effect on Angel. Q. Well, why is it clear as to Angel and not clear as to his mother? A. Because Angel didn't suffer brain damage as a result of his mother's cardiopulmonary arrest. Q. And what about the hypoxic ischemic damage? A. His neurologic examination is not consistent with the effects of hypoxic ischemic damage and his MRI scan is not consistent with hypoxic ischemic damage, and there is also a maternal history of developmental delay, which predates the pregnancy, but that's less important. * * * Q. What is the extent of Angel's developmental delay? A. He has a speech delay. He's got delayed coordination and he has delay in mature muscle tone, low muscle tone. * * * Q. Was Angel delayed in any of his developmental milestones? A. Yes, he was delayed in his motor and speech milestones. * * * Q. Do you agree that Angel Balbuena is substantially mentally and physically impaired? A. No. Q. Do you agree that Angel's mental and physical impairments such as described are permanent? A. No. Q. Do you agree that Angel Balbuena suffered from oxygen deprivation in the course of labor and delivery? A. No. Q. So it is your testimony today, Doctor, that even though Angel Balbuena's mother suffered a cardiac arrest and was resuscitated, was being resuscitated for almost 20 minutes, that had no effect on Angel's oxygen supply to his brain? A. It may have had an effect on the oxygen supply to Angel's brain, but Angel doesn't have hypoxic ischemic damage. Q. Well, what effects did the oxygen deprivation to Angel's brain during his mother's cardiopulmonary arrest before his delivery have on him? What were the effects? A. None, as far as I can tell. I mean, there may have been some transient physiologic disruption, but no permanent effects. * * * Q. You mention in your letter of July 23rd, 2003 that it is your opinion that Angel's neurologic findings are more consistent with prenatally acquired cerebral palsy. What is cerebral palsy? A. Developmental disorder of motor functioning. Q. What causes cerebral palsy? A. Most of the cases are due to unknown intrauterine circumstances. Q. What is the cause in Angel's case? A. Intrauterine factors. I don't know the precise cause, but I believe they were acquired in utero. Q. What is the factual basis for your belief that these occurred in utero? A. His neurologic examination, the MRI findings. Q. What in the neurologic examination factually supports your opinion that Angel's neurological deficits occurred prenatally or intra-utero? A. The findings of hypotonia, ataxia and speech delay are all developmentally based and likely to be related to intrauterine factors. * * * Q. What is the factual basis for your opinion that Angel doesn't have global developmental delay from a cognitive standpoint? A. He's very socially aware; he's interactive. He can gesture for his needs. He can understand commands, and that suggests that he does have communication skills. He just lacks speech. (Respondent's Exhibit F, pages 25, 26, 29, 31, 33, 34, 41, and 42) Here, the opinions of the experts offered by the parties, as well as the other proof of record, have been carefully considered. So considered, it must be resolved that, while Ms. Donado suffered cardiopulmonary arrest during labor and delivery, and there is evidence to suggest Angel may have suffered oxygen deprivation during that time, the proof fails to support the conclusion that, more likely than not, any oxygen deprivation Angel may have suffered resulted in brain injury, or that he is permanently and substantially mentally and physically impaired. In so concluding, it is noted that, given the record, there is no reason to accept the views on causation expressed by Dr. Abern, over those expressed by Dr. Duchowny, and that regardless of the cause, Angel is not permanently and substantially mentally and physically impaired.
Findings Of Fact Petitioner and Respondent operate two of the four medical equipment suppliers located on Fowler Avenue in Fort Myers. The other two companies are Fort Myers Surgical Company and American Medical Oxygen Supply Company. Petitioner received an erroneous statement from Summit Medical Supplies, Inc., containing two invoice numbers for which Petitioner had no record. When asked for a copy of these invoices, Summit Medical Supplies, Inc., provided Petitioner with copies of invoices made out to Respondent, both of which had been marked paid on the face of the invoices. These two invoices were addressed to Home Oxygen Services and Medical Equipment, Inc., 4536 Fowler Avenue, Fort Myers, Florida (Exhibit 1). Petitioner's address is 3559 Fowler Avenue and the erroneous statement addressed to Home Medical Supplies, Inc., was sent to this address. On one occasion Petitioner received a call from Smalley Transportation regarding delivery of hospital beds to Petitioner which, it was soon discovered, were addressed to Respondent. In his testimony Shawn Bayes referred to several incidents involving customers and several incidents involving businesses which had contacted his company regarding equipment belonging to Respondent. None of these incidents had been observed by the witness but had been told to him by other employees. Timely objection to this testimony was made. On one occasion a suction pump had been delivered to a patient who later requested Petitioner to pick up equipment. Upon arrival it was learned Respondent had inadvertently picked up Petitioner's pump with the other equipment provided by Respondent. The suction pump was returned to the premises from which it had been picked up by Respondent. Respondent acknowledged there has been some confusion by customers regarding whose equipment they were using but that confusion was not limited to Petitioner and Respondent but also involved the other medical supply companies. Once explained to a customer, the confusion did not recur. All of the equipment supplied by the parties is clearly identified by tags on the property containing the name and address of the supply company. All of the medical equipment suppliers with businesses in Fort Myers supply similar equipment to predominantly elderly patients, approximately 50 percent of which are covered by Medicare. These patients are referred to the supplier by doctors, hospitals, and home health agencies.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Petition of Home Medical Equipment Company be dismissed. DONE AND RECOMMENDED this 12th day of April, 1985, at Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 Filed with the Clerk of the Division of Administrative Hearings this 12th day of April, 1985. COPIES FURNISHED: Shawn D. Bayes, President Home Medical Equipment Company 11899 90th Avenue North Seminole, Florida 33542 Vincent D. Sapp, Esquire Post Office Box J Fort Myers, Florida 33902 Honorable George Firestone Secretary of State The Capitol Tallahassee, Florida 32301
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."
The Issue The issue is whether Respondent is guilty of failing to practice in accordance with the applicable standard of care or failing to keep adequate medical records and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 44240. He has been licensed in Florida since 1984. Respondent has practiced plastic surgery, particularly cosmetic plastic surgery, for the past 22 years. Respondent is certified by the American Board of Plastic Surgery in plastic surgery. He was also certified in Advanced Cardiac Life Support (ACLS) at the time of the surgery in question. The Board of Medicine previously disciplined Respondent by Final Order filed September 1, 1995, pursuant to a Consent Agreement into which the parties had entered. The Consent Agreement arose from allegations that Respondent had failed to remove a sponge from a breast during breast augmentation surgery. Respondent did not admit the allegations, but agreed to pay a $2000 fine and attend ten hours of continuing medical education. The Administrative Law Judge admitted this evidence strictly for the purpose of penalty, not liability. Respondent performs plastic surgery at the Cosmetic Surgery Center in Fort Lauderdale. The 5000 square-foot facility contains three examination rooms, two operating rooms, one recovery room, and an overnight hospital. Another physician also operates at the Cosmetic Surgery Center, which employs a wide range of staff, including a patient coordinator, nurse practitioner, and a certified register nurse anesthesiologist (CRNA). In the past, the Cosmetic Surgery Center retained a CRNA to assist in surgery on an as-needed basis. However, since mid-2005, the Cosmetic Surgery Center has regularly employed a CRNA after the Board of Medicine issued an Order of Emergency Restriction of License on June 8, 2005. Issued in response to the incident described below, the emergency order requires, among other things, that Respondent employ a CRNA or M.D. anesthesiologist to administer anesthesia at all surgeries, unless the surgery will involve Level I sedation. The emergency order also requires Respondent to obtain an unqualified surgical clearance from every patient's primary care physician. Respondent has performed over 10,000 procedures using Level II sedation over 25 years. Level II sedation leaves the patient conscious, but tranquil, and responsive to painful stimulus or verbal command. Level III sedation leaves the patient unconscious. This case involves a 50-year-old female, S. B., who presented to Respondent's office on July 9, 2003, to discuss the possibility of an abdominoplasty, breast augmentation, and arm lift. Respondent had previously performed an abdominoplasty, which is also known as a tummy tuck, on S. B.'s daughter, who wanted to make a present of cosmetic surgery for her mother. After examining S. B., Respondent recommended against any work on the arms, as the surgical scars would outweigh the benefits of the surgery for S. B. During this initial office visit, Respondent took a history from S. B., who had three children and was employed as a receptionist for a local roofing company. S. B. stated that her general health was good, and she had never had significant complications from any surgery. She reported that her only medical problem was hypertension and that she consequently took clonidine and Lasix. She stated that she had never reacted badly to general or local anesthesia, did not bruise easily, and did not bleed excessively from cuts. The form asked the patient to list intoxicating or mind-altering drugs, and S. B. did not list any. At no time during the July 9 visit did S. B. express an intent to proceed with the surgery, and, in fact, she was undecided at the time and remained so for several months. Respondent next saw S. B. on December 11, 2003, when she presented at his office for a pre-operative examination. Respondent again discussed the surgical procedures. During this visit, S. B.'s blood pressure was 210/112, which was too high for Respondent to perform elective surgery. Instead, he discussed with S. B. the need to control her blood pressure and learned that she had quit taking her blood pressure medication. Respondent told S. B. to see her primary care physician to control the blood pressure. Respondent's notes document S. B.'s blood pressure, the referral, and the purpose of the referral. In anticipation of surgery on December 23, 2003, Respondent prescribed on December 11, 2003, fifteen 500-mg tablets of Duricef, fifteen 10-mg tablets of Lorcet, and fifteen 30-mg tablets of Restoril. Duricef is an antibiotic. An analgesic, Lorcet combines 10 mg of hydrocodone, an opioid, with acetaminophen. Restoril, or temazepam, is a sedative in the benzodiazepine family and is similar to Valium. Respondent typically prescribes these or similar medications, so that his patients can fill them prior to surgery and take them following surgery. On December 11, 2003, Respondent also ordered pre- surgical lab work. The lab report, dated December 12, 2003, states that S. B.'s values were largely normal. However, S. B.'s prothrombin time (PT), which measures clotting time, was very slightly elevated. The normal range for this parameter for this laboratory is 11-13 seconds, and the PT for S. B. was 14.8 seconds. However, the International Normalization Ratio (INR), which normalizes results among labs and tissue samples, was 1.4, which is within the normal range, as was the partial thromboplastin time (PTT), which is another measure of clotting time. S. B.'s red blood cell count was very slightly high (6.13 as compared to a range of 4.2-6.1 units per liter). Also very slightly low were S. B.'s M.C.V. (79.0 as compared to a range of 80.0-99.0 units), M.C.H. (26.3 as compared to a range of 27.0-31.0 units), and M.C.H.C (32.7 as compared to a range of 33.0-37.0 units per liter). Very slightly high was S. B.'s R.D.W. (15.4 as compared to a range of 11.5-15.0 percent). Except for the red blood cell count, the other parameters pertain to precursors of cells. The next day, Respondent added to the pre-operative prescriptions two 5-mg tablets of Mephyton, which is vitamin K. The medical records contain no discussion of why Respondent added vitamin K the day after he had ordered the other pre- operative medications. Most likely, this information would have been contained in Respondent's notes, which are in a handwritten scrawl that is partly illegible. Clearly, though, Respondent's notes fail to disclose the purpose of ordering Respondent to take vitamin K. Respondent testified that he was responding to the PT value, explaining that he gives vitamin K to patients with borderline clotting studies, so that the patients will not experience as much bruising and swelling. More important than the records' failure to contain an explanation for the ordering of vitamin K is their failure to address the high PT value in Respondent's plan of treatment for S. B. Even if only borderline high and more suggestive of problems involving only bruising and swelling, the PT raised a clotting issue, which is of obvious importance given the nature of the contemplated surgery. Respondent's records must address this issue and the impact, if any, on the contemplated surgery. In retrospect, the PT abnormality proved irrelevant. S. B. did not display any clotting problems or excessive bleeding during the surgery. At the hearing, Respondent explained the limitations of a PT value, especially when it is unaccompanied by an abnormal INR, although Respondent obviously thought enough of the PT test to order one for S. B. More cogent is Respondent's explanation at the hearing that the absence of any reported history of bleeding or bruising outweighed any concerns raised by a slightly elevated PT value, but this persuasive analysis is nowhere to be found in the medical records. Petitioner argues alternatively, though, that the slightly elevated PT value should have alerted Respondent to cirrhosis, which is discussed in more detail below. At the pre- operative stage, at least, the history, findings, and complaints did not support a diagnosis of cirrhosis. In his pre-operative physical examination, Respondent found no evidence of jaundice or edema. S. B.'s anemia had resolved. Her history lacked any indication of liver disease, nor did S. B. complain of any symptoms consistent with cirrhosis. These facts, as well as the information supplied by S. B.'s primary care physician, justified Respondent's failure to explore the possibility of liver disease prior to proceeding with surgery. Nor did the circumstances impose a duty on Respondent to include in the medical records a plan of treatment that addressed the possibility of cirrhosis. The facts reasonably known to Respondent did not raise the possibility of cirrhosis, any more than they raised the possibility of heroin use by S. B. It is thus irrelevant to Respondent's documentation duties, although not necessarily to her death approximately 30 hours after the end of the surgery, that S. B. suffered from some degree of cirrhosis and used heroin. On December 31, 2003, S. B.'s primary care physician completed a "Medical Clearance" form, even though Respondent had not requested a medical clearance, but had required only that the physician do what was necessary to get S. B.'s blood pressure under control. On the form, S. B.'s primary care physician noted that S. B.'s past history consisted of hypertension and, in June 2000, anemia. The addition of the date implied that S. B. no longer suffered from anemia--a fact borne out by her elevated red blood cell count. On the form, the primary care physician noted that her blood pressure was 160/98 and pulse was 80, changed one of S. B.'s blood pressure medications, and cleared her for surgery under local and general anesthesia, "once BP < 150/90." Two items on the Medical Clearance form support Respondent's decision not to investigate the possibility of liver disease before performing surgery. First, as noted above, the form indicates that S. B.'s anemia had resolved. It would be reasonable to assume that S. B.'s primary care physician was especially attentive to indicators of anemia or liver disease given this history. Second, the Medical Clearance indicates that S. B.'s primary care physician had ordered a comprehensive metabolic panel, which would include tests of liver function. The absence of any further contact from the primary care physician implies that the comprehensive metabolic panel revealed nothing of importance as to liver function, and the function of the liver is obviously important--not its post- mortem condition. On January 15, 2004, S. B. presented at the Cosmetic Surgery Center for an abdominoplasty with liposuction to the waist area. Respondent's scrawled notes do not disclose why he or S. B. decided not to proceed with the breast augmentation. In the pre-operative evaluation, which is initialed by Respondent, S. B.'s pulse was 95, and her blood pressure was 162/96, with the notation that she was nervous. Her rating on the American Society of Anesthesiologists (ASA) scale is I, meaning that she has no disease. Respondent concedes that her hypertension warranted a II, which means some systemic disease, but not threatening. However, the mis-rating on the ASA scale is irrelevant because it did not impact her treatment or outcome. The pre-operative evaluation contains two other notations of interest. First, Respondent planned for S. B. to remain overnight at the Cosmetic Surgery Center, rather than to discharge her to home on the day of the surgery or transfer her to a hospital. Thus, her remaining at the facility the night of the surgery did not suggest an unusually difficult surgery or recovery. Second, Respondent found S. B. fit for surgery under I.V. sedation in the office, rather than local or general anesthesia. Obviously, the pre-operative evaluation reports a blood pressure in excess of the maximum listed in the medical clearance that Respondent had received from S. B.'s primary care physician. Respondent's medical records fail to address this discrepancy and the broader issue of S. B.'s blood pressure, which was about the same as it was when she visited her primary care physician, but considerably lower than when she last visited Respondent. Respondent could and did reasonably exercise his own medical judgment and proceed with surgery despite a blood pressure in excess of the maximum on the medical clearance, but given this recommendation, S. B.'s extremely elevated blood pressure a month earlier, the challenges of maintaining reasonable blood pressure levels intra- and post- operatively, and S. B.'s hypertensive condition, Respondent was required to document his reasoning for proceeding with surgery despite the relatively high blood pressure. At hearing, Respondent offered a persuasive explanation of why he proceeded to perform the surgery despite a blood pressure reading over 150/90. Attributing the elevated blood pressure (and pulse) to adrenalin-producing anxiety, not hypertension, Respondent decided that he would be able to control S. B.'s blood pressure adequately during surgery with sedatives and blood pressure medication. Considerable evidence indicates that S. B. was a very nervous patient. S. B.'s pulse was also quite rapid on both visits. As was the case with the PT value, it is easier to credit Respondent's reasoning given hindsight, as he successfully controlled S. B.'s blood pressure during surgery. During surgery, Respondent's nurse practitioner, Michelle Huff, monitored heart function by an EKG, blood oxygenation and pulse by a disposable pulse oximeter, blood pressure, and respiration. During the surgery, Respondent was also assisted by Tiffany Archilla, a certified surgical technologist. At Respondent's direction and under his supervision, Nurse Hoff, administered the following drugs immediately before and during surgery: Diprivan, which is an anesthetic whose specific effect depends on rate of administration; Versed, which is a sedative; Robinul, which controls nausea; Ancef, which is an antibiotic; fentanyl, which is an analgesic and anesthetic; and labetalol, which controls blood pressure. Nurse Huff also administered oxygen and nitrous oxide, which is an anesthetic. Nurse Huff had been working at the Cosmetic Surgery Center for only two months at the time of S. B.'s surgery. Nurse Huff is not a CRNA, but is an advanced registered nurse practitioner and has been a registered nurse for 14 years. At the time of the hearing, she had been employed for three years at the Cosmetic Surgery Center, where she also had completed an internship. She estimates that she has participated in over 1000 surgical procedures involving Level II sedation. At 8:40 a.m., Nurse Huff administered 2.5 mg of Versed, 0.2 mg of Robinul, and 1.0 g of Ancef. At 8:45 a.m., Nurse Huff started the oxygen, nitrous oxide, and Diprivan drip. The oxygen was in a two-liter bottle, and the nitrous oxide was in a four-liter bottle. The Diprivan was 500 mg in a 500 cc solution. During the surgery, Nurse Huff administered all of this Diprivan, as well as all of another 200 mg of Diprivan in a 250 cc solution, given S. B.'s resistance to sedation. In most cases, and probably in this one, Respondent uses a microchamber, which releases microdrips at the rate of 60 drops per minute. Respondent does not administer Diprivan by means of an infusion pump, which would offer more precise control of the rate of infusion. The records do not indicate the rate of administration of the Diprivan. However, Respondent rarely finds it necessary to discontinue Diprivan during surgery, and its clinical effect wears off after only about three minutes following its discontinuation, so the patient arouses quickly after Diprivan is stopped. Thus, the failure to record the rate of administration of the Diprivan is immaterial. At 8:45 a.m., Nurse Huff also administered 100 mg of fentanyl, which was followed by 50 mg doses at 8:50 a.m., 8:55 a.m., 9:05 a.m., 9:35 a.m., 9:45 a.m., 10:05 a.m., and 10:10 a.m. S. B. thus received a total of 450 mg of fentanyl. The surgery commenced at 9:30 a.m. At the start of surgery, Respondent administered subcutaneously at the surgical site 150 cc of one percent lidocaine, which is a local anesthetic, with epinephrine at 1/200,000. The epinephrine prevents the body from quickly absorbing the lidocaine. S. B.'s blood pressure had varied between 8:40 a.m. and 9:30 a.m. It started at 164/97, but was 135/85 15 minutes later. Her blood pressure remained at 145/85 from 9:00 a.m. to 9:10 a.m. At the time of surgery, S. B.'s blood pressure was 162/88. In response to the start of surgery and reflective of S. B.'s level of anxiety, her blood pressure surged to 180/95 at 9:45 a.m., and Respondent directed Nurse Huff to administer 2.5 mg of labetalol at this time. S. B.'s blood pressure reached 190/80 at 10:00 a.m., five minutes after Nurse Huff had administered another 2.5 mg of labetalol. By 10:10 a.m., S. B.'s blood pressure was down to 125/75, where it remained for the remainder of the surgery. S. B.'s other vitals remained good during the surgery. Oxygenation saturation remained over 96 percent, mostly 97 and 98 percent. Respiration remained around 18. Pulse ran in proportion to blood pressure, but settled within the range of 80-90 once S. B.'s blood pressure stabilized at 10:10 a.m. Blood loss was minimal during the surgery. Typically, a patient may lose 200-300 cc of blood, but S. B. lost only 150 cc. Proceeding conservatively, Respondent did not try to tighten the muscle wall, as he found, once he had made the incisions, that S. B. did not require this procedure. The liposuction removed 200 cc, including 150 cc of fat. Anesthesia ended at 11:05 a.m., and surgery ended at 11:10 a.m. During the surgery, S. B. had received 2000 cc of fluids. At all times, S. B. remained active and alert. Evidencing S. B.'s level of alertness during surgery was her high oxygen levels at all times during surgery and the necessity of additional Diprivan. At 11:20 a.m., S. B. was transported by stretcher from the operating room to the recovery room. At this time, her oxygen level was 98 percent, her blood pressure was 179/97, her pulse was 96, and her respiration was 16. At 11:30 a.m., S. B. received 2.5 mg of labetalol. At 11:35 a.m., S. B. was complaining of anxiety, so she received 2.5 mg of Valium. At 11:40 a.m., a nurse emptied her Foley catheter of 1600 cc of clear yellow urine. At this time, S. B.'s blood pressure was 184/105, her pulse was 95, her respiration was 16, and her oxygen level was 96 percent. She received another 2.5 mg of labetalol. At 11:45 a.m., S. B. received another 2.5 mg of Valium. At 12:15 p.m., S. B.'s blood pressure was 164/92, and she received clonidine 0.1 mg to reduce her blood pressure. Fifteen minutes later, S. B.'s blood pressure dropped to 143/88. She fell asleep at 1:00 p.m., but awoke an hour later, complaining of pain. She then received 75 mg of Demerol with 6.25 mg of Phenergan, which controls nausea. At 2:30 p.m., S. B. complained again of pain. Her blood pressure had risen to 189/78, so she received another clonidine 0.1 mg. Fifteen minutes later, a nurse emptied S. B.'s Foley catheter of 1400 cc of clear urine. S. B.'s blood pressure was 170/100, and the nurse notified Respondent of this reading. The nurse gave S. B. 10 mg of Procardia, which reduces high blood pressure. At 3:00 p.m., S. B. received 2.5 mg of labetalol and 2.5 mg of Versed. Fifteen minutes later, S. B. was transferred by stretcher to the overnight room with a blood pressure of 141/60, pulse of 96, and respiration of 16. By 3:45 p.m., S. B.'s blood pressure was 125/59, and she was asleep. Thirty minutes later, S. B. was watching television, and her blood pressure was 141/78. After complaining of pain, S. B. received 100 mg of Demerol with 12.5 mg of Phenergan at 4:50 p.m. At 5:10 p.m., S. B.'s blood pressure rose to 163/94, and her pulse was 108. She received another 10 mg of Procardia at this time. At 6:00 p.m., S. B.'s blood pressure was down to 142/88. Two hours later, after she complained of insomnia, S. B. received 30 mg of Restoril. At 9:15 p.m., S. B. complained of abdominal pain. She received 100 mg of Demerol and 25 mg of Phenergan. At 11:30 p.m., S. B. received 30 mg of Restoril for insomnia and 10 mg of Lorcet for pain. At 1:20 a.m. on January 16, S. B. was sleepy. Two hours later, her blood pressure was 148/70. At 5:30 a.m., after an uneventful night, S. B. complained of abdominal pain and received another 10 mg of Lorcet. At 7:00 a.m., her intravenous line was discontinued. Alert and oriented, S. B. walked in the hall and received another clonidine 0.1 mg. A nurse emptied her Foley catheter of 400 cc of urine and removed the Foley catheter. At discharge at 8:00 a.m., Respondent examined the wound and found no evidence of bleeding, as he changed the dressing. At this time, S. B.'s blood pressure was 147/70 and pulse was 108. S. B. was transported by wheelchair to her daughter's car. S. B. and her daughter arrived at S. B.'s home at about 9:00 a.m. on January 16, 2004. After spending the morning with her mother, the daughter left the home and returned at 1:00 p.m. Having forgotten the house key, the daughter knocked on the door, and S. B. had to crawl to the door due to her lack of strength. The daughter assisted her mother to bed. Mid- afternoon, the daughter left her mother to run some errands. When the daughter returned home shortly before 6:00 p.m., she found her mother unresponsive and curled into a fetal position on the floor with blood present on the bed sheets and nightshirt that she was wearing. The daughter immediately called 911 and requested an ambulance. The emergency management technicians (EMTs) arrived at S. B.'s home at 6:23 p.m. and found her as her daughter had found her. S. B. was in full cardiac arrest. The EMTs found S. B. cold to the touch with fixed and dilated pupils. They found a "small amount" of blood oozing from the staples in the lower stomach. The two surgical drains in the upper stomach contained no discharge. Blood had soaked the bandage and run down both legs to thigh level. The EMTs estimated blood loss at about 500 cc. The EMTs also found the Restoril and Lorcet in the doses that Respondent had prescribed pre-operatively. The EMTs attempted unsuccessfully to resuscitate S. B. and transported her to the hospital where she was pronounced dead on arrival at 6:35 p.m. The medical examiner conducted an autopsy on January 17, 2004, at which time blood and urine samples were taken for toxicological analysis. The toxicology report notes that a gas chromatography/mass spectrometry procedure revealed the presence of 6-MAM, which is a metabolite of heroin and demonstrates conclusively that S. B. consumed heroin or, much less likely, 6-MAM; morphine, which is another indicator of heroin, at a concentration of 0.22mg/L; methadone at a concentration of less than 0.05 mg/L; meperidine, which is Demerol (a narcotic analgesic) at a near-toxic concentration of 0.98 mg/L; diazepam, which is Valium, at a concentration of less than 0.05 mg/L; nordiazepam, which is a metabolite of Valium, at a concentration of less than 0.05 mg/L; temazepam, which is, as noted above, Restoril or another metabolite of diazepam, at a concentration of 0.29 mg/L; and hydrocodone, which is one of the two ingredients, as noted above, of Lorcet, at a concentration of 0.05 mg/L. A drug's half-life is the amount of time for its potency to be reduced by half. Three to four half-lives are required for the complete elimination of a drug. Because various conditions can affect the half-lives of drugs, such as liver disease as to drugs eliminated substantially through metabolism by the liver, half-lives are stated as average ranges. Relevant half-lives are: Demerol--2-24 hours; diazepam--21-37 hours; hydrocodone--3.4-8.8 hours; and temazepam--3-13 hours. Diprivan and fentanyl have very short half-lives and were not detected by the toxicologist. The half- life of 6-MAM is also very short, about 6-25 minutes, leading the toxicologist who performed the report for the medical examiner to testify that S. B. had consumed heroin not more than two hours before her death. The same toxicologist testified that the detected concentration of Demerol was six times the therapeutic level. (This testimony is credited over the testimony of the Deputy Chief Medical Examiner that the concentration of 0.98 mg/L is only twice the therapeutic level.) Given a half-life of 2-24 hours, all that can be said with certainty is that S. B. suffered even greater concentrations of Demerol--possibly much greater--prior to the near-toxic concentration found by the toxicologist. Undoubtedly, the heroin and methadone that S. B. consumed were not prescribed by Respondent. Undoubtedly, S. B. had access to Demerol that Respondent had not administered. Respondent could not have reasonably have anticipated, based on the circumstances, that S. B. would consume heroin, methadone, and toxic or near-toxic amounts of Demerol, in addition to her prescribed medications, within 12 hours of her release from the Cosmetic Surgery Center. Just as an illegal drug user has the right to treatment in accordance with the applicable standard of care, so a physician has a right to expect behavior on the part of his patient that is at least consistent with the instinct of self-preservation. The autopsy determined that S. B. died of a combined drug overdose of heroin, temazepam, Valium, methadone, Demerol, and hydrocodone. Contributing causes of death were hypertension, abdominal wall hemorrhage, and cirrhosis. As to the hypertension, the autopsy report states that S. B. suffered from mild arteriosclerotic cardiovascular disease. As to the abdominal wall hemorrhage, the autopsy report states that S. B. was in status--post-tummy tuck and liposuction. As to the cirrhosis, the autopsy report states that S. B. suffered from severe fatty metamorphosis of the liver. The autopsy report concludes that the manner of death was an accident. Of the drugs that combined to kill S. B., Respondent clearly did not administer or prescribe the heroin or methadone. Although Respondent administered Demerol at the dosages of 75 mg at 2:00 p.m. 100 mg at 4:50 p.m., and 100 mg at 9:15 p.m., all on January 15, the near-toxic Demerol found in S. B. at the time of her death was not due to these doses, but due, at least in large part, to Demerol that S. B. obtained from other sources. The hydrocodone and temazepam were probably derived, at least in part, from the Lorcet and Restoril that Respondent prescribed for post-operative use. Unfortunately, the record does not reveal how many pills of each that the EMTs found at the S. B.'s home, so it is impossible even to infer how much of each medication that S. B. took while at home during the afternoon of January 16 immediately preceding her death. Not much hydrocodone was found in S. B., and the 10 mg of Lorcet given at 11:30 p.m. on January 15 and 10 mg of Lorcet given at 5:30 a.m. on January 16 would have been nearly eliminated by the time of S. B.'s death, given the short half-life of hydrocodone. Considerably more temazepam was found in S. B., but the 30 mg of Restoril given at 8:00 p.m. and 30 mg of Restoril given at 11:30 p.m. would have been nearly eliminated by the time of S. B.'s death, given the short half-life of temazepam. Clearly, in the two or three hours before she died, S. B. took heroin, methadone, and Demerol. Clearly, the fentanyl that she had last received at 10:10 a.m. on the prior day and the Diprivan that she had last received at 11:05 a.m. on the prior day had long cleared her system before she took the heroin, methadone, and Demerol. S. B. accidentally took her own life by taking these three drugs. The record does not suggest that hemorrhaging from the surgical site was due to some failure on Respondent's part. Instead, it appears more likely that falling from the bed or possibly convulsing from the drug overdose, S. B. may have reopened the incision site. The record does not suggest that cirrhosis materially extended the half-lives of any medications that Respondent administered. S. B. efficiently eliminated the Valium that Respondent administered. The record does not explain why she would not as efficiently eliminate other drugs metabolized primarily by the liver. The record does not suggest that Respondent's management of S. B.'s hypertension intra- and post-operatively had any bearing on her demise. Her blood pressure stabilized late in the afternoon of January 15, and nothing in the record suggests that anything that transpired on that day concerning S. B.'s hypertension caused an acute crisis that resulted in her death. As to Count I, Respondent did not depart from the applicable standard of care. S. B. never fell below Level II sedation; she was always responsive to pain and attempts to communicate. S. B. proved difficult to sedate even to Level II. On these facts, it is impossible to find even that it was reasonably likely, at the outset of the procedure, that S. B. would reach Level III sedation. Additionally, as to Count I, Respondent competently managed S. B.'s hypertension intra- and post-operatively. Based on the circumstances, Respondent correctly determined that the slight elevation of PT would not interfere with clotting or endanger the patient's safety and correctly determined that the other five slight abnormalities in the lab report were immaterial to patient safety in the contemplated surgical procedure. Respondent was thus not required to obtain additional tests or to obtain a consultation for the slight PT abnormality. Based on the physical examination and lab results, including those ordered by the primary care physician, insufficient evidence of liver abnormality existed to preclude the administration of the acetaminophen contained in Lorcet. Further, the standard of care does not preclude the prescription of acetaminophen to all patients with any kind of liver disease. As to Count II, Respondent's medical records fail to document adequately why he proceeded to operate despite S. B.'s failure, pre-operatively, to reach a blood pressure of less than 150/90, why he administered vitamin K pre-operatively, and, most importantly, how he had assimilated the PT abnormality in his treatment plan for S. B. As noted above, at hearing, Respondent amply supplied all of this information--the problem is that he never bothered to do so in the medical records. Although these deficiencies in medical records did not contribute in any way to S. B.'s death, they are material failures to justify the course of treatment. In contrast to the detailed records of Nurse Huff intra-operatively and the post-operative records prepared by nurses, Respondent's notes, and thus the records themselves, do not approach the minimum level of detail necessary to justify the course of treatment in this case. As to Count III, Respondent did not administer or cause to be administered excessive or inappropriate quantities of Diprivan. As to Count IV, Respondent did not improperly delegate professional duties, with respect to the administration of Diprivan, to a registered nurse who was not a CRNA. At all times, Respondent adequately supervised and monitored the administration of this short-acting sedative. The record does not support Respondent's claim of prejudice resulting from any delay in the prosecution of this case. Any claim of prejudice due to delay is undermined by Respondent's failure to demand an immediate hearing due to the imposition of an emergency restriction on his license.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order dismissing Counts I, III, and IV of the Administrative Complaint, finding Respondent guilty of a single violation of Section 458.331(1)(m), Florida Statutes, suspending his license for 30 days, placing his license on probation for two years, requiring him to complete successfully continuing medical education on medical records, and imposing an administrative fine of $10,000. DONE AND ENTERED this 25th day of August, 2006, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 2006. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin AO2 Tallahassee, Florida 32399-1701 John E. Terrel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Lewis W. Harper Brew and Harper, PL 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 George Kellen Brew Brew and Harper, P.L. 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 Patricia Nelson Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399
