The Issue Should discipline be imposed against Respondent based upon the allegation that she failed to meet minimal standards of acceptable and prevailing nursing practice in violation of Section 464.018(1)(n), Florida Statutes (2002)?
Findings Of Fact STIPULATED FACTS: Petitioner is the state department charged with regulating the practice of nursing pursuant to Section 20.43, Florida Statutes, Chapter 456, Florida Statutes, and Chapter 464, Florida Statutes. At all times material to the Complaint, Respondent was licensed to practice as a certified registered nurse anesthetist ("C.R.N.A.") within the State of Florida. Respondent's address of record is 4409 Hoffner Avenue, Suite 328, Orlando, Florida 32812. On or about March 13, 2003, Patient M.M. presented to Endosurg Outpatient Center (Endosurg) for a colonoscopy. The colonoscopy began at or about 7:16 a.m. According to the Respondent's Anesthesia Record, Patient M.M. had a blood pressure of 120/70 at 7:30 a.m., and a blood pressure of 140/84 and an oxygen saturation of 96 percent "at the end of case." Respondent began mouth-to-mouth resuscitation and CPR at or about 7:46 a.m., then provided oxygen via a bag-valve mask at or about 7:48 a.m., and then provided oxygen by intubation at or about 7:50 a.m. Section 464.018(1)(n), Florida Statutes (2002), subjects a licensed nurse anesthetist to discipline for failing to meet minimal standards of acceptable and prevailing nursing practice. ADDITIONAL FACTS: The indications for the endoscopic procedure performed on Patient M.M. were in relation to bright red blood per rectum and anemia. The endoscopic diagnosis confirmed by the procedure was diverticulosis and internal hemorrhoids. According to Patient M.M., this was the first colonoscopy she had ever had. In the history reported by Patient M.M. prior to the procedure, there was no report of chest pain, indigestion, heart burn, or nausea. The patient did report rectal bleeding. Patient M.M. provided a history of bronchitis, but it was noted that there were no recent problems with the bronchitis. In the recount of her past medical history, she made no reference to congestive heart failure, coronary artery disease, diabetes, atrial fibrillation, angina, heart murmur, heart valve problems, or irregular heart. She did have a history in her family of heart disease; the family member was her father. By history, the patient suffered from high blood pressure. At the time the patient was seen at Endosurg she was 67 years old, 5 feet 5 inches tall, and weighed 215 pounds. Respondent has practiced for 30 years in numerous settings. Respondent was an independent contractor recently employed at Endosurg. Over time she has met her obligations in relation to continuing education for her profession. When Respondent first saw Patient M.M. on the date in question, the patient was in the holding area adjacent to the procedure room. Respondent introduced herself to the patient and checked the intravenous access. The line had been placed and Respondent checked to make certain that the line was patent. Respondent explained to the patient that the patient would be given sedation. In particular, Respondent told the patient that she would be placed under conscious-sedation during the procedure. The patient responded that her son had had post- operative nausea and vomiting, having undergone sedation, but that the patient had experienced no problems with anesthesia in the past. Respondent listened to the patient's chest. The heart was regular, in that there were no audible sounds of irregularity or murmur at that time. The patient's chest was clear. No signs of wheezing or bronchi or rales were present that would indicate upper-respiratory difficulties. Respondent was aware that the patient suffered from hypertension. Before the procedure Respondent did not observe anything in the patient's demeanor which suggested that the patient was overly anxious. As the anesthesia record reflects, the administration of anesthesia by Respondent commenced at 7:15 a.m. and ended at 7:26 a.m. The procedure commenced at 7:16 a.m. and concluded at 7:25 a.m. Before providing the anesthesia, Respondent placed a blood pressure cuff on the patient, a pulse oximeter, an EKG monitor, and a pre-cordial stethoscope. The patient was anxious and Respondent administered a total of 2 mg of Versed. The Versed was administered twice. After waiting to see the reaction to the first administration, a second administration was provided. During the administration of this medication, Respondent discussed its subjective influence with the patient. Two other persons were in the procedure room with Respondent. They were the physician gastro-endrologist, who was performing that procedure, and an anesthesia technician. The doctor involved was Dr. Nehme Gebrayel. When the scope used to perform the procedure was inserted the patient winced. In response to those circumstances Respondent provided Fentanyl, an ultra-short acting narcotic in an amount considered appropriate to the circumstances. When the scope reached the area within the colon where the scope needed to be turned, the patient grasped the arm of the technician and dug her nails into his forearm. The physician called upon Respondent to provide other sedation to allow him to continue the procedure while providing some comfort to the patient. In response Respondent gave the patient 30 mg of Propofol, an hypnotic sedative with a short half-life. Later the patient began to dig her nails into the technician's forearm once more, which the technician reported to the physician. The physician told Respondent to provide additional sedation. Respondent gave the patient 30 mg more of Propofol. While the procedure was ongoing Respondent monitored the patient's vital signs. Before the procedure, the blood pressure was 142/100, the heart rate was 72. The second reading on blood pressure taken by Respondent during the procedure occurred between 7:18 a.m. and 7:20 a.m., with a reading of 126/66. Pulse oxygen readings that were recorded at the beginning and during the procedure reflected 98 percent and 95 percent saturation respectively. When the physician began to withdraw the scope at the end of the procedure, Respondent told the patient that the procedure was being finished and that the physician was taking the scope out. The patient responded by giving a "thumbs up" gesture. When the Doctor finished the procedure, Respondent asked the patient if the patient was doing "O.K." Respondent asked the patient if the patient was experiencing discomfort, the patient responded "not really." Respondent told the patient that the patient was being taken back to the holding area where she had been picked up before and brought into the procedure room. While the physician was still in the procedure room, Respondent went to the door and opened it into the holding area, and the nurse from the PACU at Endosurg came into the procedure room. Maureen Mayhew, R.N., was that nurse. When nurse Mayhew entered the procedure room, the vital signs in relation to blood pressure, pulse, and the pulse oximeter reading were still displayed on the monitor in the procedure room. Those readings at the end of the case were blood pressure 140/84, heart rate 74, respiratory rate 16 per minute and the saturated oxygen level 96 percent. At that time the patient responded to queries and stimuli. The reference to responding to queries means that the patient was able to converse with the Respondent. When Respondent turned over the care to nurse Mayhew, she told the other nurse that the patient had high blood pressure and a history of bronchitis but that the chest was clear when listened to prior to the procedure. Respondent explained that the patient had undergone a colonoscopy, in which 2 mg of Versed, 50 mg of Fentanyl, which is the equivalent to 1 cc and a total of 60 mgs of Propofol, divided into two doses had been provided. Respondent told nurse Mayhew that the patient was awake and talking and that her blood pressure had started at 140, had drifted down to 120 and was back at 140, as to systolic readings. After Respondent released the patient to the care of nurse Mayhew, she proceeded to address the next case. The administration of anesthesia to that patient commenced at 7:27 a.m. At about 7:45 a.m. a C.N.A. at Endosurg came into the procedure room where the next case was underway. The C.N.A. stated that there was a problem with Patient M.M., in that the patient was not responding as she had been. The C.N.A. asked that the doctor and Respondent come and see the patient. After arranging for someone to continue to monitor the patient that was being examined at that moment and with the placement of intravenous fluid with that patient to keep him hydrated, Respondent and the doctor left the procedure room and entered the holding area where Patient M.M. was found. When Respondent and the physician approached the patient, the patient was alone, flat on the bed. Respondent checked the patient's pulse at her neck, while the physician checked the patient's pulse at the wrist. Respondent called the patient's name and rubbed on the patient's chest. The patient made no response. The patient had no pulse. Respondent told the doctor "I don't have a pulse here." The doctor responded "Neither do I." When Respondent and the doctor addressed the patient in the holding area, they were uncertain when the patient had stopped breathing. The doctor commenced chest compressions as a form of CPR. Respondent leaned over the patient and breathed two quick breaths into the patient through mouth-to-mouth CPR. Respondent asked someone else employed at Endosurg to bring the CODE cart. Someone asked the Respondent if they needed to call 911. Respondent said, "yes" and the call was placed. Respondent was handed an ambubag with a valve mask to assist the patient in breathing. To check the bag's operation Respondent squeezed twice and found that the bag was not working. This bag belonged to Endosurg, and by inference Endosurg, not the Respondent is found to be responsible for its maintenance. During the inception of the mouth-to-mouth resuscitation provided by her, Respondent noticed that the patient's chest rose which is an indication that the patient was being ventilated. By contrast, the initial ambubag provided no evidence that ventilation was occurring. When the facility ambubag failed, Respondent asked another employee at Endosurg to go and pick up her personal ambubag that was located in another part of the procedure room. While someone went to retrieve Respondent's personal ambubag, the Respondent continued to provide mouth-to-mouth resuscitation while the physician gave closed chest compressions to the patient. During that time the chest was rising, indicating that the patient was making ventilatory efforts. When the second ambubag, belonging to Respondent, was handed to her, it was connected to oxygen and it performed as expected. The patient was given several quick breaths of the oxygen through the ambubag. Respondent then used a laryngoscope and an endotracheal tube to intubate the patient and the patient was intubated. While being ventilated through the endotracheal tube, Respondent used a stethoscope to listen to the breath sounds of the patient and she found evidence that the endotracheal tube was secure. While this was occurring the physician continued chest compressions. The physician also administered certain drugs to the patient to assist the patient. One drug being administered to the patient at the time was Epinephrine. The patient was then defibrillated. The defibrillator did not have a separate monitor. It was one in which the paddles associated with the defibrillator were not hooked to a device that would produce print strips of the results when the paddles were applied. This defibrillator belonged to Endosurg. The Respondent and the physician relied upon the EKG monitor hooked up to the patient to gain information and her status. When the Respondent and the doctor had come into the holding area, the patient was not on the monitor. The physician placed the leads on the chest of the patient to connect the monitor to reflect the pulse rate, if any were present. When the patient was first defibrillated and there was no change in the heart rhythm, another dose of Epinephrine was administered. About that time the fire rescue unit that had been summoned by the 911 call arrived. That was at 7:51 a.m. The fire rescue personnel included an EMT paramedic qualified to maintain the airway for the patient. Those persons took over the patient and prepared the patient for transfer. Respondent asked the doctor if it was acceptable to return to the procedure room and check the status of that patient. The physician gave her permission but Respondent did not return to the procedure room until the EMT paramedic had checked the position of the endotracheal tube in Patient M.M. Through the efforts made by Respondent and the physician the patient regained her pulse. A note in the patient's records refers to the existence of the heart rate and pulse when the patient was turned over for transport to a hospital. That hospital was the Villages Regional Hospital. There the patient was diagnosed with cardiac arrest and anoxic brain damage, encephalopathy. Subsequently the patient was transferred to Leesburg Regional Medical Center. The decision was eventually made to remove the patient from life support, given her condition. In an interview nurse Mayhew gave to an investigator with the Department of Health, relied upon by the parties at hearing, Ms. Mayhew told the investigator that five patients were in the PACU at Endosurg when Patient M.M. was transferred to that unit. At the time there was only one registered nurse and a single C.N.A. in the unit. Liz Singleton was the C.N.A. Ms. Mayhew told the investigator that Ms. Singleton indicated to Ms. Mayhew that the patient was alert and talking when the patient entered the unit. Ms. Mayhew said that she gave Patient M.M. a rapid assessment shortly after the arrival of the patient in the unit. Ms. Mayhew told the investigator that she noted that the Patient M.M. had declined from alert to responsive at that time. When checking the color and vital signs, a decrease in blood pressure was noted and the patient was placed in the Trendelenberg position (head down, feet raised) to try to increase the blood pressure. Ms. Mayhew mentioned giving Patient M.M. a sternal rub. The patient was noticed to blink her eyes and move her shoulder. Fluids were started, and the patient was given Romazicon intended to reverse the effects of anesthesia that had been provided to the patient during the procedure. Ms. Mayhew told the investigator that she gave C.N.A. Singleton instructions not to leave the patient's bedside and to give the patient one-on-one care. Ms. Mayhew then went to arrange for another C.N.A. to assist in the PACU. At some time during the care provided by nurse Mayhew, she indicated that there was a monitor for blood pressure, oxygen saturation, respiration and pulse and that the alert alarms were set. Nurse Mayhew told the investigator that she was starting an IV two beds away and heard the second C.N.A. talking to Patient M.M. just before the alarms went off. She said that Patient M.M. was in respiratory arrest and that she called a CODE, meaning nurse Mayhew called a CODE. Any entries concerning the vital signs in relation to Patient M.M. that were made following the procedure while the patient was in the holding area were made by C.N.A. Singleton, according to nurse Mayhew's statement. The monitor had printout capabilities at the time but was not activated. Notwithstanding these remarks attributed to nurse Mayhew in the interview process, it is found that when Respondent and the doctor addressed the patient in the holding area the monitor was disconnected. Although in her remarks made to the investigator nurse Mayhew said that the vital signs were recorded by the C.N.A., the record of nursing assessments reflecting the recording of the vital signs was signed by nurse Mayhew. They show that at 7:30 a.m. the patient's blood pressure was 78/46, with a pulse rate of 52, and a respiratory rate of 12. At 7:35 a.m. the blood pressure was 74/42, with a pulse rate of 40, and a respiratory rate of 14. The physician gave certain post-op orders concerning Patient M.M. which were noted by nurse Mayhew when she affixed her signature. One of those orders indicated that Ms. Mayhew was obligated to "notify physician for blood pressure less than 90/60, pulse >110." This order was not followed. EXPERT OPINION: Cenon Erwin Velvis, C.R.N.A., has been licensed in Florida for eleven years. He was called as an expert for Petitioner to testify concerning Respondent's care rendered Patient M.M. in this case. The witness was received as an expert. Both the Respondent and Mr. Velvis have provided anesthesia on numerous occasions while patients were undergoing colonoscopies. To prepare himself for the testimony, nurse Velvis reviewed medical records pertaining to Patient M.M. and the investigative report of the Department of Health. His opinion is that Respondent in caring for Patient M.M. fell below the standards expected of a C.R.N.A. when considering acceptable and prevailing nursing practice. Concerning his opinion, nurse Velvis believes that Patient M.M. was transferred to the PACU in an unstable condition, that Respondent did not remain with the patient long enough to ascertain this instability and the need for treatment and to conduct an ongoing evaluation secondary to the side effects of the anesthesia, and that once the patient experienced difficulties, the airway and circulatory system were not secured by Respondent in a timely manner. Nurse Velvis believes that the blood pressure reading at 7:30 a.m. of 78/46 and heart rate and pulse of 52 are low, dangerously so. According to nurse Velvis the normal range is 120/80 for blood pressure. There can be an acceptable 15 to 20 per cent departure from what is considered normal. This takes into account that nature of the procedure that the patient had undergone. The vital signs that were reflected at 7:30 a.m. demonstrate patient instability at 7:30 a.m., in Mr. Velvis' opinion. The Romazicon administered to the patient would not ordinarily be used given the amount of anesthesia provided the patient in the procedure. The patient's responsiveness had progressed to a point from what was initially assessed as responsive or responding to queries, to an unresponsive state. This would account for the administration of Romazicon, a reversal agent to the tranquilizer that had been used during the procedure. Nurse Velvis notes that the patient had gone from responding to inquiries to a state of unresponsiveness where the patient would only move when given painful stimuli. Mr. Velvis was aware that the blood pressure at 7:35 a.m. was 74/42, with a pulse rate of 40, indicating a further decline. The approximate time of arrest for the patient was 7:45 a.m. from records reviewed by Mr. Velvis. Mr. Velvis believes that the Respondent was responsible for verifying the patient's vital signs upon admission to PACU. He also originally expressed the opinion that Respondent failed to utilize the intubation equipment in a timely fashion to restore breathing following the emergency. Mr. Velvis concedes that if the cardiac arrest that occurred with Patient M.M. were related to anesthesia, the respiratory response by the patient would be lowered. But the recording of a respiratory rate of 12 at 7:30 a.m. and 14 at 7:35 a.m. does not satisfy Mr. Velvis concerning the quality of ventilation in the patient, even with the efforts of the patient being recorded. He also makes mention that the level of oxygen saturation at those times was unknown when reviewing the record. He does acknowledge that a respiratory rate of 14 as such is not consistent with respiratory arrest. Mr. Velvis acknowledges that nothing in the record indicates that nurse Mayhew notified the doctor when the low blood pressure readings were taken at 7:30 a.m. and 7:35 a.m., contrary to post-op orders. When provided a hypothetical under interrogation at hearing, that reflects the facts that have been reported here concerning the Respondent and the doctor in their effort to restore Patient M.M.'s breathing, Mr. Velvis retreated from his opinion that the airway and circulatory system of the patient was not secured in a timely manner when confronted with the crisis. While Mr. Velvis changed his opinion during cross- examination at hearing concerning the response by Respondent leading to the defibrillation, he still continued to express the opinion that Respondent fell below the standard of care and was responsible for hypoxia in the patient, the patient not breathing. He also restated his opinion that Respondent was below the standard of care for her release of the patient from the procedure room into the PACU in an untimely manner. Mr. Velvis expresses the opinion that immediate patient care was the Respondent's responsibility but in the atmosphere of team work the physician was the captain of the ship. Although the physician was the captain of the ship, the Respondent was responsible to do what was most important for the patient, according to Mr. Velvis. Mr. Velvis recognizes that nurse Mayhew would have been more helpful if she had notified Respondent and the physician earlier about Patient M.M.'s condition in the holding area, and Ms. Mayhew's error in leaving the patient when the patient was unstable. Mr. Velvis expresses the opinion that the mechanism behind the cardiac arrest in Patient M.M. was a lack of oxygen, in that the airway was not secure. Mr. Velvis in his testimony concedes that the patient could have had cardiac failure not due to a problem with respiration. Michael A. Binford, M.D., was called by Respondent as an expert. He is a practicing anesthesiologist in Florida who completed his anesthesiology residency approximately ten years ago. He works with C.R.N.A.s in his practice and as such is able to offer opinion testimony about the performance of C.R.N.A.s in their practice. He is familiar with the type of procedure which Patient M.M. was undergoing and the drugs administered to provide anesthesia. Having reviewed the patient's records and the investigative report from the Department of Health, his opinion is that Patient M.M. was stable when transferred from Respondent's care to nurse Mayhew's care. That opinion is based upon vital signs recorded at the commencement, during, and at the end of the procedure. From what he saw in the record concerning the medication administered to the patient during the procedure, it was appropriate. Nothing that he saw in the record made Dr. Binford believe that the Respondent should have stayed with the patient for a longer period of time, given the amount of medication provided. By contrast Dr. Binford refers to the vital signs recorded when the patient was under nurse Mayhew's care at 7:30 a.m. and 7:35 a.m. Those are not vital signs of a patient in a stable condition. Dr. Binford believes that the patient was deteriorating at that time and that nurse Mayhew violated the physician's post-op order by not immediately notifying the doctor of the vital signs she found. Dr. Binford in referring to nurse Mayhew's statement given to the investigator, reads the statement to indicate that the patient was stable when entering the PACU but declined from alert to responsive. To Dr. Binford this reflects a change in mental status in the patient. Definitive evidence in the change in status is borne out by the vital signs taken at 7:30 a.m., and 7:35 a.m., in Dr. Binford's opinion. Although the Romazicon given by Nurse Mayhew would not have been a drug of choice for Dr. Binford, he understands that nurse Mayhew may have considered it appropriate to provide an antidote to the Versed by using Romazicon. Dr. Binford did not believe that the Versed would have caused the low vital signs encountered by nurse Mayhew. Having reviewed the autopsy report related to Patient M.M., Dr. Binford believes that a cardiac event was associated with the lower vital signs. He does not believe that the respiratory rate of 12 and 14 found at 7:30 a.m. and 7:35 a.m. respectively are consistent with respiratory arrest. Dr. Binford explains that the process involved with a heart attack, which is also referred to a myocardial infarction, is in relation to the entire heart or some segment within the heart not getting sufficient oxygen. If the patient is not breathing for a period of time, the total level of oxygen in the blood drops significantly. That is a possibility. The second possibility is that if there is plenty of oxygen in the blood, but one of the blood vessels supplying the heart muscle becomes blocked and no blood can get past the obstruction, this can also cause oxygen deprivation. Either explanation can cause damage to the heart and the brain. The first example is one in which problems are experienced in getting air and oxygen into the lungs, that can be picked up and transported around the body and the second explanation involves a problem with getting the blood flow into the area as needed. The first example related to problems of respiration is referred to by Dr. Binford as a primary respiratory event. The second example is referred to as a primary cardiac event, involving restricted blood flow. In Dr. Binford's opinion if the patient has respiratory difficulty, the respiratory rate ranges from 0 to 8, which was not the case here. In Dr. Binford's opinion neither the Versed or Romazicon were responsible for the vital signs shown in the patient while she was in the holding area. In Dr. Binford's opinion the cause of the patient's decline was indicative of a primary cardiac event, as opposed to a primary respiratory event and the anesthesia as a causative agent would not explain it. He expresses this opinion within a reasonable degree of medical certainty. Given his knowledge of the case, Dr. Binford did not find any deficiencies in the way the Respondent treated the patient. Within a reasonable degree of medical certainty Dr. Binford believes that the Respondent met her obligations as to the basic standards for her profession in the pre-operative phase, during the procedure, upon the release of the patient to nurse Mayhew and in response to the emergency in the holding area. Having considered the opinions of both experts, the opinion of Dr. Binford is more persuasive and is accepted as it exonerates Respondent for her conduct.
Recommendation Based upon the facts found and the conclusions of law reached, it is RECOMMENDED: That a final order be entered dismissing the Administrative Complaint. DONE AND ENTERED this 8th day of December, 2005, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of December, 2005. COPIES FURNISHED: Irving Levine Assistant General Counsel Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Damon A. Chase, Esquire Chase Law Offices, P.A. Post Office Box 196309 Winter Springs, Florida 32719 Alex Finch, Esquire 2180 Park Avenue, Suite 100 Winter Park, Florida 32789 Dan Coble, Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent's license to practice medicine in the state of Florida should be revoked, suspended or otherwise disciplined.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all time relevant to this proceeding, the Respondent was licensed to practice medicine in the state of Florida, having been issued license number 0024212. Respondent is also licensed to practice medicine in the states of Pennsylvania, New York, New Jersey and Illinois. Respondent is an anesthesiologist who was board certified in 1962, and has had experience as a professor of anesthesiology. The two cases involving patients L. Y. and O. G. that are in issue in this proceeding arose while Respondent was practicing at Manatee Memorial Hospital in Bradenton, Florida. It is the recovery room nurse's responsibility to fill out the post anesthesia care unit (PACU) record which documents the patient's course through the recovery room. The record includes notations which track the patient's activity, respiration, blood pressure, consciousness and color. Each category is scored on the basis of 0, 1 or 2. Each individual score is determined by the recovery nurse's observation of the patient and her judgment of the patient's condition at that particular moment. Ambu-bagging is a procedure whereby a mask with a reservoir bag of oxygen is placed over the nose and mouth of the patient and the bag is squeezed to force air and oxygen into the lungs of patient. Ambu-bagging is used in situations where the patient is not breathing and the procedure, in effect, breathes for the patient. PATIENT, L. Y. L. Y., a 72 year-old female who presented with abdominal pain and was initially evaluated in the emergency room of Manatee Memorial Hospital on March 22, 1988. The emergency room physician, James A. DeRespino, M. D., diagnosed the patient's condition on admission as abdominal pain/rule out perforated viscus. Jose Estigarriba, M. D., the physician called in for consultation on March 23, 1988 by Robert A. Fishco, the attending physician, diagnosed the patient's condition as acute abdomen, peritonitis, possible perforated viscus. L. Y. was in extremely ill health upon her admission. L. Y. had diabetes, chronic high blood pressure, coronary artery disease, recurrent heart failure, congestive heart failure and a history of pulmonary edema. L. Y. was on multiple medications for her diabetes and cardiovascular disease. Both Dr. Estigarribia, the patient's surgeon, and Dr. Fishco felt that immediate surgical intervention was necessary to determine and correct the problem. L. Y. initially refused to have the surgery for approximately 24 hours. However, after talking with Dr. Fishco the patient finally consented to surgery late in the afternoon of March 23, 1988, approximately 24 hours after admission to the hospital. After the patient consented to surgery, Dr. Estigarribia immediately discussed with the patient the various invasive monitoring techniques and retaining the patient on a respirator after surgery. The patient refused these procedures because of difficulties she had experienced during similar procedures in the recent past. At this point, Dr. Estigarribia determined that it was best to move the patient to surgery as quickly as possible and dispense with such devices as swan-ganz catheters because he was concerned that she may change her mind and decide against surgery. The Respondent was first notified of the surgery approximately fifteen minutes prior to L. Y. being transported to the operating room. Respondent saw the patient in the operating room and took a history. Dr. Estigarribia informed the Respondent of the urgent situation and of the patient's refusal to consent to ventilation therapy and invasive monitoring. Respondent anesthetized the patient using a rapid sequence induction. Dr. Estigarribia then performed an exploratory laparotomy, resection of the small bowel, end-to-end anastomosis, and peritoneal lavage on the patient. After the surgery was completed but prior to the patient being extubated, Respondent checked the patient's blood pressure (120/70) and pulse rate (90), found the patient's color to be good and her oximetry (oxygen saturation of blood) readings to be satisfactory. Just prior to extubation, the patient's blood pressure was 140 over 90, her pulse rate 90, her oximetry reading was 96, she was breathing on her own and was conscious to the point of being able to communicate with Respondent by opening her eyes when asked a question. After making certain that the patient was breathing on her own and was conscious, Respondent extubated the patient while still in the operating room. Shortly thereafter, approximately 10 minutes, the patient was moved to the recovery room. The patient progressed satisfactorily in the recovery room. The patient's PACU score upon arrival in the recovery room at 10:30 p.m. was 5 out of a possible 10, with consciousness and activity each being given a score 0 by the recovery room nurse and respiration a score of 1. However, within 10 minutes the patient had improved to a total score of 9, with a consciousness and activity each being given a score of 2 and the respiration score remaining at 1. The total score remained at 9 until 12 midnight, approximately one and one-half hours after the patient was delivered to the recovery room. At 12:30 a.m., approximately two hours after her admission to the recovery room, the patient's score dropped to a total of 4 and the patient experienced ventricle fibrillation and expired as a result of this cardiac event at approximately 12:47 a.m. There is competent substantial evidence in the record to establish facts to show that Respondent's treatment of patient, L. Y. was within that level of care, skill, and treatment recognized as being acceptable under similar conditions and circumstances at the time of extubation and subsequent recovery room care, notwithstanding the testimony of Dr. Monroe and Dr. Kruse to the contrary which was based primarily on the hospital's records and more specifically on the recovery room nurse's scores and notes in the PACU records. PATIENT, O. G. Patient, O. G., is a sixteen year old male athlete who sustained a fractured mandible in an athletic event. O. G. was admitted as an emergency case to the Manatee Memorial Hospital on June 9, 1988 with a diagnosis of acute fracture of the mandible and laceration of the mouth. On June 9, 1988 the patient's attending surgeon performed an open reduction of the right angle of the mandible and the removal of four impacted wisdom teeth. Respondent placed the patient under general anesthesia for the above scheduled procedure. When the operative procedure ended (at approximately 6:55 p.m.), Respondent remained in the operating room with the patient approximately 30 minutes to assess the patient's post-operative condition. While still in the operating room the patient exhibited the usual indicators for extubation. The patient's oximetry readings were good, his blood pressure and pulse were good, he was breathing on his own with adequate title volume, he responded when given verbal commands, and was able to lift his head. At this point in time, the patient was having adverse reaction to the tube used by Respondent to maintain the patient's airway. Based on his training and experience as an anesthesiologist, using the above indicators, the Respondent determined that the patient was ready to be extubated. The patient was extubated in the operating room by the Respondent before being transferred to the recovery room. Upon being delivered to the recovery room, at approximately 7:25 p.m., the patient's condition began to deteriorate. The patient's breathing became shallow and he did not respond to verbal commands. The Respondent had the recovery room nurse remove the blanket covering the patient so that the Respondent could observe the patient's respiratory pattern and coloration to determine if the patient needed assistance with breathing and to give assistance, if needed. The Respondent had the nurse place the patient on 100% oxygen. Normally, a patient is placed on 40% oxygen. The patient did not recover from the anesthesia as quickly as the Respondent had anticipated. Notwithstanding the recovery room nurse's testimony as to her observation of the patient's condition as set out in the PACU records, the patient's condition was not so life threatening as to require intervention by the Respondent prior to the time he decided to call in a pulmonologist. While I do not doubt the competence of the recovery room nurse, the Respondent's testimony that his observation of the patient's condition during this period of time led him to believe that it was not life threatening was more credible. It was the Respondent's observation of the patient's condition that guided him in choosing a conservative procedure in his handling of the patient. Although Respondent was assisting with other operations in the hospital during this time, he stayed within voice range of the patient and nurse, monitoring the patient's condition and periodically assisting or having the nurse assist the patient in breathing by using an Ambu-bag and when necessary, either the Respondent or the nurse, would suction off blood secretions through the nasal passage. The Respondent chose this conservative procedure of monitoring the patient's condition rather than performing a "blind" intubation through the nasal passage or by cutting the wires holding the patient's jaws shut and intubating through the mouth thinking the patient would respond without the necessity of reintubation. The first procedure would have involve the risk of pushing possible blood clots into the lower portion of the patient's airway, while the second procedure would necessitate that the patient undergo an additional operation. Eventually, when O. G. failed to respond, Respondent decided to reintubate the patient. However, since the Respondent had decided against a "blind" intubation through the nasal passage or cutting the wires on the jaws to intubate through the mouth, he decided to intubate using a fiber optic bronchoscope in order to visualize the airway and remove any blood clots that may have formed in the upper portion of the airway as a result of the surgery. This procedure would avoid the risk of pushing the blood clots down into the lower part of the patient's airway. Since Respondent was not a pulmonologist he was not given the privilege at Manatee Memorial Hospital to use a fiber optic bronchoscope. Therefore, Respondent sought the services of David Law, M. D., a pulmonologist on call at the hospital that evening, to perform the reintubation using the fiber optic bronchoscope. Dr. Law reintubated the patient using the fiber optic bronchoscope. Dr. Law found blood clots in the upper portion of the patient's airway which were removed before attempting the reintubation. The patient was then transported to the Intensive Care Unit and afterwards recovered satisfactorily. Dr. Law opined that he would not have attempted a "blind" nasal reintubation of the patient under the circumstances here because of the possibility of pushing blood clots down into the lower portion of the patient's airway. In the medical community a pulmonary physician is the specialist most experienced with the use of a fiber optic bronchoscope, and it would be unusual for a non-pulmonary physician to use a fiber optic bronchoscope under circumstances similar to those occurring with this patient. There is competent substantial evidence in the record to establish facts to show that Respondent's treatment of the patient, O. G. was within that level of care, skill, and treatment recognized as being acceptable under similar conditions and circumstances at the time of extubation and subsequent recovery room care, notwithstanding the testimony of Dr. Monroe and Dr. Kruse to the contrary which was based primarily on the hospital's records and more specifically on the recovery room nurse's scores and notes in the PACU records.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint filed in this case. RECOMMENDED this 15th day of January, 1993, at Tallahassee, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of January, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-0596 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the parties in this case. Petitioner's Proposed Findings of Fact. Proposed findings of fact 1, 3, 4, 5, 6, and 9 are adopted in substance as modified in findings of fact 1, 6, 7, 5, 13, and 16, respectively. Proposed finding of fact 2 is unnecessary. Proposed finding of fact 7 is neither material nor relevant to the conclusion reached in the Recommended Order. Proposed findings of fact 8 and 16 go to the credibility of the expert witnesses and are unnecessary as findings of fact. Proposed findings of fact 10-15 and 17-22 are rejected as not being supported by substantial competent evidence since there is more credible evidence supporting a finding contrary to the findings set forth in these proposed findings of fact. 6. Proposed findings of fact 23, 24-25, 29, 30, 31, 33-35, 39- 42, 39, 40, 41, 42, 43 and 44 are adopted in substance as modified in findings of fact 19, 20, 21, 23, 22, 4, 23, 25 and 5, respectively. Proposed finding of fact 26 although acceptable is unnecessary. Proposed findings of fact 27 and 28 go to the credibility of a witness and while they may be accurate they are unnecessary. 9. Proposed findings of fact 32, 36-38, 45-51, 55-71, 73, 75, 77, 78, 80-82, 84, 85, 88-96 are accepted as the testimony of the recovery nurse and the experts who testified in this case and a reflection of the hospital's records, particularly the PACU records upon which the experts relied in given their testimony or opinions. However, they are not necessarily adopted as findings of fact because the more credible evidence is to the contrary. See findings of fact 22-30. Proposed finding of fact 52 is accepted but unnecessary since it relates to proposed findings of fact 53 and 54 which are rejected as not being supported by competent evidence in the record. See finding of fact 25. Proposed finding of fact 72 is rejected as not being supported by competent substantial evidence in the record. Proposed findings of fact 74, 76, 79 and 83 are adopted in substance as modified in findings of fact 27, 28, 30 and 24-26, respectively. Proposed finding of fact 86-87 are accepted but unnecessary since there was no showing that patient suffered heart failure and pulmonary edema. Proposed findings of fact 97-101, 103 and 104 are more a restatement of testimony than findings of fact but see findings of fact 24-26. Proposed finding of fact 102 deals more with the credibility of a witness but see finding of fact 24. Proposed finding of fact 105 is rejected, see findings of fact 24-26. Respondent's Proposed Findings of Fact. Proposed finding of fact 1 is unnecessary. Proposed findings of fact 2 - 20 and 22 are adopted in substance as modified in findings of fact 1, 2, 1 & 2, 3, 6, 7, 8, 8, 9, 10, 11, 12, 13, 14, 16, IS, 18, 17, 17 and 18, respectively. Proposed finding of fact 21 is more of a discussion of the testimony of Drs. Monroe, Kruse and Kozma rather than being stated as a finding of fact and is therefore, rejected. COPIES FURNISHED: Richard A. Grumberg, Esquire Senior Attorney Department of Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Allen Bobo, Esquire Roger Lutz, Esquire Lutz, Webb, Bobo and Baitty, P. A. One Sarasota Tower Two North Tamiami Trail Sarasota, Florida 34236 Dorothy Faircloth Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
The Issue This is a license discipline case in which Petitioner seeks to take disciplinary action against Respondent, a licensed medical doctor, on the basis of alleged violations of paragraphs , (m), (t), and (x) of Section 458.331(1), Florida Statutes. The alleged violations are set forth in two administrative complaints, both of which were docketed as a single case when they were referred to the Division of Administrative Hearings.1
Findings Of Fact Respondent, Robert H. Hunsaker, M.D., is now, and was at all material times, licensed as a physician in the State of Florida, having been issued license number ME0051546. Respondent, a board certified plastic surgeon, was employed by the Premiere Center for Cosmetic Surgery ("Premiere Center") in Coconut Grove, Florida, when the surgeries that led to the matters at issue in this proceeding were performed. All acts of alleged sexual misconduct at issue in this proceeding are alleged to have occurred in the recovery room at the Premiere Center following surgery by Respondent. The recovery room at the Premiere Center is a small area with walls on three sides and a curtained entrance. Just outside the curtained portion of the recovery room there is a large reclining chair. There are two beds in the recovery room. The bed against the left wall can be tilted up or down, and both patients E.R. and S.C. were placed in the bed on the left side of the room with their heads toward the rear wall and their feet toward the curtained entrance. This bed has railings, which are raised at all times when a patient is in the bed to prevent the patient from falling out. The recovery room is adjacent to the operating room. To benefit the patient, the recovery room is kept dimly lit. People frequently walked through the area just beyond the curtained portion of the recovery room. Any of 8 or 10 Premiere Center employees would have occasion to walk through this area at one time or another. Furthermore, the only ingress and egress to the operating room and recovery room was through the door located in the area just beyond the curtained recovery room. When a patient at the Premiere Center was transferred from the operating room to the recovery area, the patient routinely was placed in the middle of the bed, with the bedrail up to prevent the patient from falling out of the bed. Any patient at the Premiere Center routinely had an I.V. line in his or her left arm or hand, with a pulse oximeter clipped to a finger on the left hand. If the pulse oximeter clip were to become detached from the patient’s finger, an alarm would sound. The pulse oximeter monitors heart rhythm with an audible “beep” sound, and monitors oxygen saturation with a steady tone that lowers in frequency if oxygen saturation drops. Thus, if the surgeon is in the room immediately adjacent to the recovery area, the surgeon can be aware of the status of the pulse and the oxygen saturation of a patient in the curtained recovery area. During, as well as immediately following, all of the surgical procedures that led to the matters at issue in this proceeding, Respondent was wearing surgical garb, including scrub pants that did not have a fly. The scrub pants he wore were fastened at the waist by a drawstring, which consisted of a piece of non-elastic stout cord or lace, similar to a very long shoelace. It was Respondent's practice then (and still) to tie the drawstring in the same type of bow as is typically used to tie shoelaces. At all times pertinent to the issues in this case, Respondent tried to be one of the last people the patient saw before going under anesthesia and one of the first people the patient saw upon waking up. He did this in an effort to provide each patient with a sense of reassurance and to relax the patient. At the times pertinent to this proceeding, Respondent employed a post-operative practice of establishing physical contact with a patient while the patient was regaining consciousness following surgery. This practice was applied to both male and female patients. This contact usually consisted of holding the patient's hand or touching the patient's arm or shoulder. The purpose of the contact was to reassure and relax the patient. As part of this routine, Respondent would speak to the patient in soft and reassuring tones, asking the patient how he or she felt and telling the patient that the surgery was successful.6 Both patients E.R. and S.C. were administered general endotracheal anesthesia. Among the anesthetic agents administered to E.R. and S.C. were: Brevital, Fentanyl, Forane, Inapsine (also called Droperidol), and Nitrous Oxide. In addition, both E.R. and S.C. were pre-medicated with a drug belonging to the benzodiazepine class – Valium, in the case of E.R., and Versed (also called Midazolam), in the case of S.C. Experts for both Petitioner and Respondent agree that the purpose of anesthesia is to alter the sensory perception of the patient so that noxious stimuli will not be processed, and the patient will not remember the surgical event. Some anesthetic agents are strong amnesics, meaning that they cause the patient to not remember the noxious stimuli for a time following administration. Other anesthetic agents are analgesic, altering the patient’s sensation to noxious stimuli. Versed is a strong amnesic, as is Valium. Both Versed and Valium are in the same class of drugs known as benzodiazepines. Benzodiazepines can cause post-operative hallucinations, and dreaming during emergence from the effect of the drug. Nitrous Oxide, Forane, and Fentanyl all change the patient’s perception of touch. Inapsine provides a state of mental detachment. Inapsine can cause post-operative hallucinations, as is stated in the drug package insert. The effects of all of these drugs can be enhanced when they are taken in combination. These anesthetic agents can contribute to a confabulation, and cause an environment ripe for confusion. The anesthesia used on these patients greatly altered their ability to perceive sensory input, including touch.7 While in the recovery room following their respective surgeries, both E.R. and S.C. were on the verge of unconsciousness, could not stay awake, and could not judge time.8 Although it was Respondent's practice to monitor his patients post-surgery by listening to the equipment and visually checking on the patient “at least two times,” this monitoring was supplemental to the monitoring activities of the Premiere Center employees whose primary job was to monitor the patients’ recovery and make the recovery room notations on the patients’ charts. Respondent often did this type of supplemental patient monitoring while making notes in medical charts or dictating operative reports at a work area in the room immediately outside the curtained portion of the recovery area. While doing these other tasks, he could also be aware of any significant change in the sounds made by the monitoring equipment. The Premiere Center employees primarily responsible for recovery room monitoring and notations were the Certified Registered Nurse Anesthetist ("CRNA") and the “circulator.” In May of 1996, Patient E.R., a female patient who was 43 years old at that time, met with Dr. Hunsaker to discuss plastic surgery to modify the shape of her nose. Following this consultation, E.R. consented to rhinoplasty surgery, and after a pre-operative workup, E.R. presented to the Premiere Center early in the morning on May 21, 1996. E.R. met with Dr. Hunsaker, and was then prepped for surgery. E.R. was pre- medicated with intravenous Valium (2.5 mg) and taken to the operating room, where she was administered general anesthesia. Dr. Hunsaker performed the surgery without incident and Patient E.R. was then moved to the recovery room. There was a lady in the bed next to her in the recovery room. In the recovery room, Patient E.R. awoke briefly from the anesthesia and called out for Suzanne DeRibeaux. No one answered her call and E.R. then fell asleep again. When Patient E.R. awoke again, she recalled being very frightened because she could not see. Dr. Hunsaker was standing at her bed, on the left side, and holding her left hand. Patient E.R. asked why she could not see and if she had lost her eyesight. Dr. Hunsaker told her not to be scared and that she could not see because she had ice packs on her eyes. The ice packs blocked Patient E.R.’s vision directly in front of her face. However, she was able to look underneath the pack and see her feet and the wall to the right of her bed. She was not able to see to her left without turning her head to the left. She did not turn her head to the left while Respondent was in the recovery room. Although Patient E.R. could not see Dr. Hunsaker, she could hear his voice. He asked her how she was feeling and if she could feel what was in her hand. Dr. Hunsaker pressed her hand around his fingers and she answered that she could feel what was in her hand. Dr. Hunsaker then asked Patient E.R. what was in her hand and she answered, “Those are your fingers.” When Patient E.R. awoke again, Dr. Hunsaker was still present at her bedside and had his hand underneath her left hand. Patient E.R. still had ice packs on her eyes, but was able to hear members of the Premiere staff walking and talking. Respondent held her hand and she believes he was trying to get her to squeeze something with her hand. Patient E.R. was frightened and did not say anything at the time. Patient E.R. was afraid to turn her head to the left to look at Respondent.9 After Dr. Hunsaker left Patient E.R. in the recovery room area, a nurse came into the room and helped Patient E.R. out of the bed and into a wheelchair. At that time, Patient E.R.’s friend, Carmen LeClair, was at the surgery center to pick up Patient E.R. and drive her to her mother's home. Ms. LeClair helped Patient E.R. to get dressed. Eventually, E.R. sat up, was put into a wheelchair, and, assisted by a nurse and by Carmen LeClair, walked to Ms. LeClair’s car. Ms. LeClair then drove Patient E.R. to the home of E.R.'s mother. At some time while she was in the bed in the recovery room, Patient E.R. began to think that perhaps Respondent might have placed his penis in her hand or might have placed her hand on his penis. During the time she was in the recovery room and shortly after she left the recovery room, Patient E.R. was not certain whether the sexual misconduct she believed might have occurred had in fact occurred or was instead something she had dreamed or hallucinated.10 More than a year later, Patient E.R. still could not be certain whether her recollection of sexual misconduct by Respondent was a recollection of an event that actually happened, or was a recollection of a dream or a hallucination. More than a year after the her surgery by Respondent, when Patient E.R. discussed the matter with Valerie McAllister for the first time, Patient E.R. was more inclined to believe that she had been hallucinating, rather than to believe that the misconduct had actually taken place.11 In May of 1997, Patient E.R. returned to the Premiere Center for some additional plastic surgery on her nose. Until that time, Patient E.R. had not told anyone at the Premiere Center anything about any alleged sexual misconduct by Respondent. In May of 1997 when she presented to the Premiere Center for the second surgery, Patient E.R. made a request to the Premiere Center’s CRNA, Valerie McAllister, that she not receive the same anesthesia as the previous year. She told Ms. McAllister that the reason for this request was because the last time, in E.R's own words, "I believe I was hallucinating that the doctor had put his penis in my hand." Ms. McAllister told Patient E.R. that she should discuss the matter with Suzanne DeRibeaux. Suzanne DeRibeaux was an employee of Premiere Center who had testified against Respondent in the 1997 hearing. About a week later, Patient E.R. discussed her concerns about the 1996 surgery with DeRibeaux. At that time, Ms. DeRibeaux informed E.R. that there were several other women (perhaps as many as six) that, in Ms. DeRibeaux's words, Respondent “had done this to.” Ms. DeRibeaux handed E.R. a business card for AHCA investigator, Susan DeCerce. E.R. met the investigator at the State Attorney’s Office (“SAO”) on June 4, 1997, where E.R.’s statement was taken by DeCerce. Patient E.R. was informed by both DeCerce and by personnel from the SAO that there were other women making the same allegations against Dr. Hunsaker. In her statement to DeCerce, Patient E.R. told DeCerce she thought she was squeezing a “pressure gauge” and not Dr. Hunsaker’s penis. Patient S.C. is a female who was 19 years old when she went to the Permiere Clinic seeking plastic surgery services. After initial and pre-operative consultations with Dr. Hunsaker, Patient S.C. presented on May 7, 1996, at the Premiere Center for bilateral breast augmentation. The patient's mother and boyfriend took her to the Premiere Center on the morning of the surgery. Patient S.C. was duly prepped, pre-medicated with Versed, and taken to the operating room where she was administered general anesthesia, consisting of the same anesthetic agents that were administered to E.R. Surgery was performed without incident by Dr. Hunsaker and Patient S.C. was then moved to the recovery room. While in the recovery room, Patient S.C. woke up and fell asleep again at least three times that she remembers. On at least two of those times when she woke up in the recovery room, her mother was standing beside her bed. On at least one of the occasions when she woke up in the recovery room, Respondent was standing beside her bed.12 Patient S.C. recalls that shortly after she woke up she heard Respondent asking how she felt and asking if she was O.K. Patient S.C. also recalls that at some point in her recovery room experience, Respondent held her hand. Consistent with his usual practice, Respondent held S.C.'s hand as she was emerging from anesthesia in the recovery room and asked how she was feeling. Respondent never held Patient S.C.'s hand against his penis, nor did he place Patient S.C.'s hand inside his surgical scrub pants. At some time while she was in the bed in the recovery room, Patient S.C. began to think that perhaps Respondent might have held her hand and then might have placed her hand on his penis. During the time she was in the recovery room and during the period shortly after she left the recovery room, Patient S.C. was not certain whether the sexual misconduct she believed might have occurred had in fact occurred, or was instead something she had dreamed or hallucinated.13 When she woke up the last time, Patient S.C. recalls that her mother was at S.C.'s bedside. S.C.'s mother assisted her in getting dressed, and S.C.'s mother and boyfriend took S.C. home. S.C. did not say anything to her mother about any alleged sexual misconduct by Respondent until many months later, following a television newscast about Respondent. S.C. did mention something vague to her boyfriend as he was carrying her to the car in the Premiere Center parking lot, which was to the effect that, "I thought something had happened in the room."14 Well over a year after her surgery, Patient S.C. saw a television newscast on Channel 10 in which it was stated that a number of other women had come forward with allegations that Respondent had manipulated their hands onto his penis during their recovery from anesthesia. The newscast also stated that anyone else who had been through a similar experience should come forward. Patient S.C. contacted the news station. The newscaster took Patient S.C.'s name and telephone number, and shortly thereafter AHCA field investigator Susan DeCerce contacted S.C. Respondent emphatically denied that he engaged in sexual misconduct with any of his patients.15 Respondent's testimony, including his denial of any sexual misconduct, is found to be credible.16 During the course of his treatment of Patient L.P., Respondent did not engage in any sexual misconduct of any kind with the patient. Specifically, Respondent did not at any time, in the recovery room or elsewhere, place his penis in Patient L.P.'s hand or cause Patient L.P.'s hand to come in contact with his penis.17 During the course of his treatment of Patient A.V., Respondent did not engage in any sexual misconduct of any kind with the patient. Specifically, Respondent did not at any time, in the recovery room or elsewhere, place his penis in Patient A.V.'s hand or cause Patient A.V.'s hand to come in contact with his penis. During the course of his treatment of Patient E.R., Respondent did not engage in any sexual misconduct of any kind with the patient. Specifically, Respondent did not at any time, in the recovery room or elsewhere, place his penis in Patient E.R.'s hand or cause Patient E.R.'s hand to come in contact with his penis. During the course of his treatment of Patient S.C., Respondent did not engage in any sexual misconduct of any kind with the patient. Specifically, Respondent did not at any time, in the recovery room or elsewhere, place his penis in Patient S.C.'s hand or cause Patient S.C.'s hand to come in contact with his penis. During the course of his treatment of Patients L.P., A.V., E.R., and S.C., Respondent did not keep a post-anesthesia record tracking the recovery of any of these four patients while they were in the recovery room. Respondent learned for the first time that vital signs were not recorded during the recovery of patients E.R., S.C., A.V., and L.P. only after the Administrative Complaints in this case were filed. None of the four patients suffered any harm from the absence of recordation of vital signs during the recovery period. During the time period in which Respondent was treating patients L.P., A.V., E.R., and S.C. (calendar year 1996), in a private office surgery setting, in the normal course of events, the anesthesia provider (either anesthesiologist or CRNA) would chart the patient’s immediate post-anesthesia recovery. Further recovery room charting would normally be the responsibility of the person assigned to take over the recovery from the anesthesia provider. During that time period and under those circumstances, the surgeon's responsibility to make a record of events in the recovery room existed only where the surgeon actually intervened during the recovery room period to provide some form of treatment (such as changing I.V. fluid or administering medication) or if there were a dramatic or unusual event during the course of the recovery. With the exception of Respondent's administration of Droperidol to Patient S.C. (which was noted in the medical record), there were no such events in the recoveries of Patients E.R., S.C., A.V., and L.P., and, consequently, no requirement that Respondent make recovery room notations during the recoveries of these patients. During the time period in which Respondent was treating Patients L.P., A.V., E.R., and S.C. (calendar year 1996), and under the circumstances in which Respondent was treating those patients (in an office surgery setting in which the facility was providing the CRNA anesthesia provider and was also providing an employee to recover patients in the recovery room), Respondent was not responsible for preparing the record of the patient's recovery room experience. Rather, at that time and under those circumstances, the person responsible for preparing the recovery room record was either the person who administered the anesthesia (the CRNA) or the employee of the facility who was assigned to monitor the patient in the recovery room and who was the person to whom the CRNA would entrust the patient's recovery room care once the CRNA was satisfied that the patient was sufficiently stable. During the time period in which Respondent was treating Patients L.P., A.V., E.R., and S.C. (calendar year 1996), and under the circumstances in which Respondent was treating those patients, a reasonably prudent similar physician under the same or similar circumstances would have recognized Respondent's failure to keep a post-anesthesia record tracking the recovery of any of these four patients while they were in the recovery room as being acceptable, because such a reasonably prudent similar physician would have expected the recovery room record to have been prepared by the anesthesia provider or other person assigned to monitor the patient in the recovery room. During the time period in which Respondent was treating Patients L.P., A.V., E.R., and S.C. (calendar year 1996), and under the circumstances in which Respondent was treating those patients, Respondent's failure to keep a post- anesthesia record tracking the recovery of any of these four patients while they were in the recovery room was not a failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the time period in which Respondent was treating Patients L.P., A.V., E.R., and S.C. (calendar year 1996), and under the circumstances in which Respondent was treating those patients, Respondent's failure to keep a post- anesthesia record tracking the recovery of any of these four patients while they were in the recovery room was not a failure to keep written medical records justifying the course of treatment of the patient, because the responsibility for the preparation of such records was a responsibility of the anesthesia provider or other person assigned to monitor the patient while the patient was in the recovery room. In such time and circumstances the surgeon was not responsible for the preparation of such records in the absence of some unusual circumstances, which unusual circumstances did not occur in any of the recovery room experiences following the surgeries at issue here.18
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be issued in this case to the following effect: Adopting all of the findings of fact in this Recommended Order, Adopting all of the conclusions of law in this Recommended Order, Concluding that the evidence is insufficient to establish any of the charges in either of the administrative complaints at issue in this case, and (3) Dismissing all charges contained in both of the administrative complaints at issue in this case. DONE AND ENTERED this 26th day of February, 2004, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH 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 26th day of February, 2004.
The Issue Whether Respondent violated section 458.331(1)(t), Florida Statutes, by committing medical malpractice.
Findings Of Fact Petitioner is the state agency charged with the regulation of the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to these proceedings, Respondent was licensed as a physician in the State of Florida and held license number ME50399. Dr. Lopez immigrated to the United States with his family at a young age from Cuba. Spanish is his first language, and he is completely fluent in English. He attended primary and secondary schools in the United States. He graduated from the University of Georgia with a bachelor of science degree in chemistry. He attended medical school at the Medical College of Georgia in Augusta, Georgia, He completed his residency at Emory University in Atlanta, Georgia. Dr. Lopez has been board-certified in obstetrics and gynecology since 1990, and was so certified at the time of the incident giving rise to these proceedings. At the time of the hearing, Dr. Lopez was employed by Palm Beach Medical Group. He was seeing obstetrical and gynecological patients for “in- office” only consultations and care. Although he has delivered over 10,000 babies and performed hundreds of obstetrical and/or gynecological surgeries over the course of his more than 33-year career, as of August 2017, he elected to no longer deliver babies or perform surgeries. His obstetrical patients are now delivered by hospital-based obstetricians, and he refers out all patients requiring surgery to other surgeons. He has voluntarily elected not to reactivate his hospital privileges at any hospital at this time. The patient, O.C. (“O.C.”), a 40-year-old female, was admitted to Good Samaritan Medical Center (“Good Samaritan”) on July 25, 2017. Good Samaritan is a local community hospital. It is neither a trauma center nor a teaching hospital. On that same day, at approximately 8:03 p.m., Respondent delivered the baby of O.C. after a scheduled induction. During the delivery, O.C. suffered one or more cervical lacerations and developed a postpartum hemorrhage. Respondent performed a postpartum cervical exam at O.C.’s bedside with a vaginal speculum. The medical records reflect that Respondent’s visualization of the cervix during the exam was hampered by bleeding. Respondent found multiple cervical lacerations, which he documented that he repaired. However, O.C. continued to bleed heavily and her condition deteriorated. By 8:40 p.m., O.C.’s blood pressure had fallen to 95/58. Despite her worsening condition, Respondent delayed taking O.C. to the operating room (“OR”) for surgical exploration. At or around 9:40 p.m., O.C. was taken to the OR in an “unresponsive state,” and Respondent performed a supracervical hysterectomy. Following the surgery, blood was observed flowing from the incision in O.C.’s abdomen. Respondent chose not to reopen the surgical incision and instead ordered the application of pressure dressings to treat the bleeding. Even though O.C. was still bleeding, Dr. Lopez left the hospital at approximately 11:42 p.m. Upon her arrival to the intensive care unit (“ICU”), O.C.’s wound dressing was saturated with blood. At approximately 3:00 a.m., on July 26, 2017, ICU nurses observed blood “gushing” from the hysterectomy incision and from her vagina. Shortly thereafter, O.C. experienced cardiac arrest and expired. Experts Dr. Diebel, a highly accomplished physician, testified as a medical expert for Petitioner. Dr. Diebel became licensed to practice medicine in Florida in 1977.1 During his practice, he maintained board certification in obstetrics and gynecology from the American Board of Obstetrics and Gynecology. Dr. Diebel has not practiced medicine for two years (although he was still engaged in his medical practice at the time of the incident giving rise to these proceedings); has not actively managed a patient with postpartum hemorrhage in over three years; has not participated in any specialized simulated training in the treatment and management of postpartum hemorrhages; is not affiliated with a similarly-situated local community hospital; and has only been affiliated with trauma and teaching hospitals (where doctors and medical school residents are on site 24/7 and operating rooms are staffed, equipped, and immediately accessible around the clock). Dr. Feld, also a highly accomplished physician, testified as an expert for Respondent. Dr. Feld has practiced medicine in Florida since 1978. He has maintained board certification in obstetrics and gynecology from the American Board of Obstetrics and Gynecology since 1980. Dr. Feld testified that, with respect to each of the allegations contained in the Petitioner's Complaint, Respondent met the standard of care, because he practiced medicine with that level of care, skill, and treatment, which is recognized by a reasonably prudent similar physician as being acceptable and appropriate under similar circumstances. Standard of Care Failure to Take O.C. to the OR for Laceration Repair Dr. Lopez testified that he had a clear and independent recollection of the patient and the events surrounding her delivery and post-delivery treatment. She had been his patient for more than a decade, and he had delivered her first child. The patient was of Cuban heritage. Dr. Lopez knew the patient's husband, mother, and aunt, who is also a medical doctor. In light of his personal relationship with the patient and her family, Dr. Lopez was motivated to perform at his highest professional level to assure a good outcome. He canceled his office appointments and spent the day at the hospital with the patient and her family. O.C. suffered a small perineum tear2 and cervical lacerations following the delivery of her baby. Dr. Lopez performed an examination and repair of the lacerations in the delivery room. He encountered difficulties during the procedures because of inadequate lighting and a view obstructed by bleeding. He violated the standard of care when he failed to take O.C. to the OR when these issues arose. 1 Dr. Diebel testified that he is currently retired. 2 Perineal tears are damage to the area between the vaginal opening and anus that occur during vaginal delivery and can range in severity. Bleeding following a delivery is normal, but heavy bleeding should typically stop within a few minutes. Normally, if visualization is good, repairing a cervical laceration takes two or three minutes. Dr. Lopez repaired the small perineum tear and began the cervical laceration repair at 8:10 p.m. At 8:30 p.m., the medical records reflect that he remained at O.C.’s bedside and performed cervical repair. Nurse Gavagni has a clear recollection of the events in this case, due to the traumatic effect it had on her. This is the first and only maternal death she had experienced in her eight years working as an obstetrics nurse. Nurse Gavagni assisted Dr. Lopez during his examination and repair of O.C.’s cervical lacerations. Dr. Lopez requested that Nurse Gavagni use a metal retractor because he was having a difficult time seeing inside the vagina. Dr. Lopez requests the use of a metal retractor in cervical laceration repairs where he has difficulties seeing the upper and lower parts of the vagina. A retractor is an L-shaped device used to hold the upper part of the vagina. Nurse Gavagni testified that the laceration repair took a while to complete. As Dr. Lopez performed the repair, the bleeding was “kind of heavy.” Dr. Lopez attempted to reduce the bleeding by placing mini lap pads (“pads”) inside of O.C. to tamponade the cervix. Tamponading is a technique whereby pads can be placed inside the cervix, similar to a tampon, to determine whether bleeding is coming from the cervix or somewhere else. Nurse Gavagni stated that the delivery tray is usually prepared with ten pads on it. During the repair, 20 soaked pads were weighed to estimate O.C.’s blood loss. The records indicate that the weight of the soaked pads was 526 grams or ccs. This estimate did not include blood collected in the bag and under O.C.’s bottom. Dr. Diebel testified that the use of a pad to reduce bleeding for a moment to visualize the cervix and repair it is reasonable; however, the use of 20 pads suggests enough bleeding to move a patient into the OR to evaluate and perform the repair. Dr. Lopez claims that he only used one or two of the pads to tamponade the cervix, and the others were used to “blot” the vagina. Furthermore, he asserts that most of the pads were not “soaked” but “soiled.” Tr., pp. 393-395. Dr. Lopez’s testimony is not credible because the records clearly reflect that 20 “soaked” pads were weighed. Additionally, Nurse Gavagni confirmed that the soaked pads were used and weighed at or around the time that Dr. Lopez performed the repair. The evidence is clear and convincing that 20 pads were soaked after being used during the laceration repair because Dr. Lopez was having trouble visualizing the cervix due to heavy bleeding. In addition to bleeding, Dr. Lopez experienced issues with lighting in the delivery room during the laceration repair. Nurse Gavagni testified that the timer on one of the overhead lights was broken, and it had to be supplemented with a portable light on wheels. She described the portable light as a “spotlight.” During the repair, the portable light was knocked over several times, causing Dr. Lopez to ask everyone to leave the room. Furthermore, the charge nurse was called in to hold the timer on the broken light so that it would stay on. The evidence is clear and convincing that the broken light was problematic during laceration repair. According to Dr. Diebel, good, sustained lighting is necessary when repairing a cervical laceration. Additionally, there should be no obstruction between a physician’s vision and the cervix. Dr. Diebel also testified that lighting in an OR is better than that in a delivery room. This would certainly be true in a delivery room with a malfunctioning light. In this instance, Dr. Lopez needed to take O.C. to the OR to perform a thorough pelvic exam to ascertain the source of the bleeding. Dr. Diebel testified clearly and credibly that the exam and repair could not be performed adequately in the delivery room, given the circumstances. The continued bleeding and inadequate lighting should have prompted Dr. Lopez to take O.C. to the OR to ascertain the source of the bleeding. Dr. Lopez’s failure to do so violated the standard of care. In formulating his opinion in this case, Dr. Diebel acknowledged that the standard he applied was that level of care, skill, and treatment, which, in light of all the relevant surrounding circumstances, is recognized as acceptable and appropriate by a reasonably prudent, similar healthcare provider, or what the average obstetrician/gynecologist would do under similar circumstances. Dr. Lopez testified that the malfunctioning timer was part of a “decorative” light located over the head of the delivery bed. The light was not useful to him because he spent most of his time at the “south end” (the foot) of the bed. Dr. Lopez claims that the light may have been useful to Nurse Gavagni because she was probably taking the patient’s vitals and entering notes into the computer at the head of the bed. Dr. Lopez’s testimony is inconsistent and not credible. On the one hand, he testified that Nurse Gavagni assisted in the repair by holding the retractor. Then when questioned about lighting, he stated that she was probably taking vitals and entering notes. Nurse Gavagni testified clearly and credibly that she helped Dr. Lopez during the repair by holding the retractor. She never mentioned that the inadequate light interfered with her ability to take O.C.’s vitals or enter information in the computer. Her testimony about the lighting issue was in the context of Dr. Lopez’s exam and laceration repair. Dr. Feld testified that constant, adequate light, without obstruction, is necessary during a cervical laceration repair, and blood gushing out of the vagina can interfere with visualization of the cervix. Dr. Feld would take a patient to the OR for a laceration repair if he could not stop the bleeding. He admitted that he has no personal knowledge of what Dr. Lopez’s visualization was at the time of his repair of O.C.’s lacerations. The evidence is clear and convincing that Dr. Lopez had trouble visualizing O.C.’s cervix during the laceration repair due to bleeding and inadequate lighting. He violated the standard of care by failing to take O.C. to the OR to better evaluate the source of the bleeding and to perform the repair. Delay in Taking O.C. to the OR Following the laceration repair, O.C. continued to bleed and her condition quickly deteriorated. Still, Dr. Lopez delayed taking O.C. to the OR to address the bleeding. By at or around 8:40 p.m., O.C. had received fundal massage3 and various medications, including Pitocin4 and Hemabate,5 to stop the bleeding. Yet, she continued to bleed and began exhibiting deteriorating vital signs. At 8:45 p.m., O.C.’s blood pressure was 95/58, and she was vomiting. O.C. was hypotensive,6 tachycardic,7 hypoxic,8 and starting to turn gray. By 8:57 p.m., her blood pressure dropped to 66/46, and she was minimally responsive. If Dr. Lopez had, as he testified, repaired the cervical lacerations, sewed the perineal tear, and administered proper medications, and O.C. 3 Fundal massage, also called uterine massage, is a technique used to reduce bleeding and cramping of the uterus after childbirth. 4 Pitocin is a natural hormone that causes the uterus to contract and can be used after childbirth to control bleeding. 5 Hemabate is the brand name for the drug carboprost. Carboprost is a synthetic prostaglandin with oxytocic properties. It is used to reduce bleeding during postpartum hemorrhage. 6 Hypotensive is relating to or suffering from abnormally low blood pressure. 7 Tachycardia is a rapid heartbeat that may be regular or irregular, but is out of proportion to age and level of exertion or activity. 8 Hypoxia is a condition in which the body or a region of the body is deprived of adequate oxygen supply at the tissue level. continued to bleed, there was nothing left to do except take her to the OR. Continued attempts at treating O.C. were futile until the source of her bleeding was addressed. Dr. Diebel testified that had Dr. Lopez taken O.C. to the OR to evaluate the bleeding when attempting the laceration repair, as the standard of care required, he could have addressed O.C.’s deteriorating condition more appropriately. Since he did not take her to the OR at that time, he should have been prompted to take her at or around 8:30 p.m. Instead, Dr. Lopez waited another hour before making the decision to take O.C. to the OR. Dr. Lopez claims that from 8:45 p.m. to 9:25 p.m., he was waiting for an available OR and an anesthesiologist. This testimony is inconsistent with Nurse Gavagni’s recollection of the events and is also refuted by the medical records. Nurse Gavagni testified that there was no wait for an OR that evening. On the Labor and Delivery floor at Good Samaritan, there was always one OR ready for an emergent patient. On the evening of this incident, an OR was available for O.C. When describing the OR, Nurse Gavagni stated that it is “never left completely unprepared … most of it is set up, and then all the scrub tech does is go in and open the tools and scrub and get dressed.” She also noted that hysterectomy trays were readily available. The medical records do not reflect that there was any delay in taking O.C. in for surgery based on the unavailability of an OR. Dr. Diebel agreed with Nurse Gavagni’s testimony that most hospitals have one OR that is reserved and available for emergencies. Dr. Feld testified that when he worked at Good Samaritan, he could get emergency cesarean section patients into the obstetrics OR within 15 to 20 minutes. The evidence is clear and convincing that an OR was available for O.C. that evening. Dr. Lopez’s claim that he was waiting on an anesthesiologist between 8:45 p.m. and 9:25 p.m. also falls short of being accurate because the medical records reflect that anesthesia was not even called until 9:25 p.m. Dr. Lopez attempted to minimize O.C.’s failing condition by alleging that she stopped bleeding at certain times prior to being taken to the OR. However, Nurse Gavagni testified clearly and credibly that O.C. never stopped bleeding and continued having at least a moderate trickle, or a continuous light to moderate stream. This is clearly supported by the records which indicate a consistent deterioration of her vitals from 8:45 p.m. to 9:25 p.m. Dr. Lopez also attempted to minimize O.C.’s condition by noting that her blood pressure was 118/52 at 9:30 p.m., shortly before she was taken to the OR. Dr. Diebel believes that O.C.’s blood pressure reading at 9:30 p.m. was a spurious result. This is based upon the fact that two minutes before that reading, at 9:28 p.m., O.C.’s blood pressure was 67/32. Furthermore, for the preceding hour, her blood pressure had gradually worsened, without any signs of significant recovery. Dr. Diebel stated that the blood pressure reading at 9:30 p.m. did not make physiologic sense, given O.C.’s condition, and it certainly, in and of itself, did not mean that she should not have been taken into surgery. Dr. Lopez testified that in a postpartum hemorrhage, the rapid response team should be called if the patient experiences a change in vital signs and hemodynamic instability. Rapid response is a protocol that can be initiated when trying to prevent a patient from coding (dying). A rapid response team provides a physician with additional staff, like more nurses and/or other specialties, to assist in treating an emergent patient. In this case, the records reflect that rapid response was not called until 9:25 p.m., more than 40 minutes after O.C.’s vitals began to deteriorate. Thus, by Dr. Lopez’s own admission, there was a delay in treating O.C. O.C. was not taken to the OR until 9:38 p.m., approximately one hour and 45 minutes after the bleeding first began. When she arrived in the OR, she was cold, clammy, and had blood gushing from the vaginal canal. Dr. Diebel testified that by the time she was taken to the OR, O.C. was in irreversible shock. Once in the OR, O.C.’s surgery was further delayed because Dr. Lopez had to wait on his supervising physician, Dr. Alfred Tomaselli. Pursuant to a prior Board Order in effect at the time of this incident, Dr. Lopez was restricted from performing any surgical procedures without supervision by another board-certified obstetrician. Therefore, Dr. Lopez could not operate on O.C. until a supervising physician arrived at the OR that evening. Nurse Gavagni recalled calling Dr. Tomaselli from the OR to find out where he was. This is corroborated by the records which show that O.C. arrived at the OR at 9:38 p.m., but the first incision did not occur until 10:01 p.m. Dr. Feld believes that Dr. Lopez’s timing in taking O.C. to the OR was “absolutely perfect,” even though the outcome was unfortunate. He testified that O.C.’s condition would not have changed if Dr. Lopez had taken her into the OR sooner because she was already in a downward spiral, due to DIC.9 He claims that O.C. had signs of DIC as early as her admission to Good Samaritan. Dr. Diebel disagrees with Dr. Feld’s belief that O.C. was in DIC at the time of her admission, since there is no evidence in the medical records to 9 DIC, or disseminated intravascular coagulation, is a condition affecting the blood's ability to clot and stop bleeding. support that position. Additionally, he stated that he was not convinced that O.C. experienced DIC prior to or after the hysterectomy. Dr. Diebel vehemently disagreed with Dr. Feld’s assertion that taking the patient to the OR earlier would not have made any difference in her outcome. He testified clearly and credibly that O.C.’s condition deteriorated steadily, which could have been avoided had Dr. Lopez taken her to the OR sooner. Dr. Lopez attempted on several occasions to place blame on Good Samaritan Hospital for lack of preparedness related to treatment for postpartum hemorrhage. He also emphasized that Good Samaritan is a community hospital lacking the capabilities of an academic center like Orlando Regional, or a trauma facility. Yet, the record clearly reflects that nothing prevented him from taking O.C. to the OR sooner. Additionally, no evidence was offered to show that Good Samaritan lacked the necessary medications, infrastructure, or equipment to adequately address O.C.’s condition. In light of all of the above, the evidence is clear and convincing that Dr. Lopez fell below the standard of care by not taking O.C. into the OR sooner. Performance of Supracervical Hysterectomy Instead of Total Abdominal Hysterectomy At 9:40 p.m., O.C. consented, in writing, in both English and Spanish, to a total abdominal hysterectomy (“TAH”). O.C. and her husband were made aware that, after a TAH, they would not be able to have any more children. They responded that they did not intend to have any more children. The consent O.C. signed included an acknowledgement that other surgical procedures might become necessary. A TAH is the surgical removal of the cervix and the uterus. Instead of performing a TAH, Dr. Lopez performed a supracervical hysterectomy. A supracervical hysterectomy is the surgical removal of the top part of the uterus, leaving the cervix in the patient. Dr. Lopez testified that he performed a supracervical hysterectomy because it is a quicker procedure than a TAH. This statement is inconsistent with testimony he gave in a prior deposition, wherein he stated that a supracervical hysterectomy is “more surgery” and takes more time to perform than a TAH. When confronted with this discrepancy, Dr. Lopez claimed that his prior testimony was “wrong” and must have been a “typo” on the part of the court reporter. However, in the deposition, Dr. Lopez provided a detailed explanation as to why a supracervical hysterectomy takes longer than a TAH, clearly showing that it was not a typo. Dr. Lopez does not have ICU privileges at Good Samaritan. Accordingly, he delegated the follow-up care for O.C. to Dr. Reynold Duclas, the anesthesiologist who was present in the OR for the surgery and afterwards, and to Dr. Tanvir Salaam, the intensivist who appeared via telemedicine. Dr. Lopez then left Good Samaritan to return home to find some clean clothes. Dr. Lopez believed the patient was stable and in good hands when he left Good Samaritan. Dr. Lopez stayed near his cell phone when he returned home and was available when he received a call from the hospital at 3:04 a.m. He returned to the hospital where he found O.C. in the ICU bed and the code was in progress. He ended the code because the patient had died. While O.C. was in the ICU, blood was drawn for lab work at 1:20 a.m. At about 2:22 a.m., the ICU received an emergency critical value telephone call that the patient’s lab work was abnormal, and that she had developed DIC. Dr. Lopez did not receive a call from the lab or the hospital until the 3:04 a.m. call described above, which was when the patient was coding. An autopsy was performed that confirmed O.C. had died from DIC. Dr. Lopez testified, and the evidence reflects, that while he was actively managing the patient, no bloodwork had indicated she was suffering from DIC. This testimony conflicts with Dr. Feld’s testimony that there was nothing Dr. Lopez could have done because O.C. was already in a “downward spiral” due to DIC. Dr. Lopez testified that, based on lab work performed at 1:20 a.m., “the patient had never sustained a hypoxic injury to her liver, she had not sustained a hypoxic injury to her kidneys, that she had not sustained, on the basis of the clinical parameters, any irreversible damage from the time of the surgery.” The patient had, in fact, showed: evidence that her brain was functioning … [s]he started to show purposeful movement and followed instructions for movement by a nurse that her cerebral cortex and her mechanical physical being was capable of movement from the brain to the muscles. That her kidney function was improving was evidenced by the fact that the blood that she had once sustained in her urine had cleared and she was making urine. At no time did the delay in taking her to the operating room cause irreversible hypoxia, irreversible unsustainable conditions that would lead to her death. Dr. Diebel testified that Dr. Lopez should have performed a TAH in this case, because it would have prevented the potential for any additional bleeding following the surgery. He explained that after performing a TAH, a physician must sew together the front wall and back wall of the vagina. He described this as “very straightforward,” and less likely to lead to “bad bleeding.” In comparison, when performing a supracervical hysterectomy, the physician must sew over the cervical stump, which consists of more substance to cinch down and suture. Additionally, based on the circumstances during the laceration repair, Dr. Diebel noted that it was not clear that the cervix was not still a source of bleeding. This complements and supports his opinion that a TAH should have been performed to ensure cessation of bleeding. Dr. Diebel testified clearly that the appropriate standard of care required that Dr. Lopez perform a TAH and not a supracervical hysterectomy. Another reason Dr. Lopez offered for performing a supracervical hysterectomy was that the procedure was less likely to expose another organ to injury. He claimed that O.C. had a hematoma involving the lower uterine segment, and this affected his decision not to perform a TAH. In his operative note (“op note”) for this procedure, Dr. Lopez did not identify a hematoma as the reason for performing a supracervical hysterectomy over a TAH. The only mention of a hematoma appears after the removal of the uterus. Therefore, it could not have affected Dr. Lopez’s decision-making in performing a supracervical hysterectomy. Dr. Feld does not remember if there was a hematoma noted in Dr. Lopez’s op note, but he believes that performance of a supracervical hysterectomy was appropriate because it is quicker and safer, given the swelling and blood clots around the cervical vaginal junction following delivery. Dr. Diebel challenged Dr. Lopez’s claims that a hematoma on the lower uterine segment affected his decision to perform a supracervical hysterectomy. Dr. Diebel pointed out that the op note specifically states that the bladder flap was taken down easily, and a hematoma was not noted until after Dr. Lopez removed the top of the uterus. As a result, Dr. Lopez could have performed a TAH without concern of a hematoma. When asked why the hematoma appeared in his op note after the uterus was already removed, Dr. Lopez claimed that his dictation may not have been “in sequence.” He testified that “a dictated operative note may indicate abnormal findings that may not be in sequence to the procedure that is performed.” He also stated that whether an op note is written in sequence “depends on the op note and depends on the circumstance.” Dr. Feld disagreed with Dr. Lopez and stated that op notes should be dictated in the sequence that the procedure is performed, from start to finish. Dr. Diebel testified that he has never heard of a surgeon dictating an op note that is not in sequence with the order in which the surgery was performed. He does not know how a surgeon would “get it out of order.” Dr. Lopez’s attempt to justify his decision to perform a supracervical hysterectomy instead of a TAH is clearly self-serving and discredited by the medical records and expert testimony of Dr. Diebel. The evidence is clear and convincing that Dr. Lopez fell below the standard of care by performing a supracervical hysterectomy instead of a TAH. Leaving the Hospital Dr. Lopez left the hospital immediately following the surgery, even though O.C. was still in critical condition. Nurse Gavagni testified that during O.C.’s surgery, the anesthesiologist was unable to obtain a blood pressure and could only report a heart rate and respiratory rate. This suggests that O.C.’s condition was extremely perilous. Dr. Lopez completed the procedure at or around 11:00 p.m. Soon after the surgery, while O.C. was still in the OR, Nurse Gavagni noticed blood coming from the incision site and reported it to Dr. Lopez. Dr. Lopez opted not to reopen and instructed Nurse Gavagni to pressure dress the wound and put ice on it. He also ordered an abdominal binder to be applied. Despite the bleeding and critical condition of his patient, Dr. Lopez left the hospital at or around 11:39 p.m. At 11:42 p.m., O.C. was transferred to the ICU. When O.C. arrived in the ICU, the dressing on her wound was soaked with blood. In the ICU, O.C. came under the care of Dr. Salaam, the intensivist. Dr. Salaam was available via telemedicine and not physically present at the hospital. Dr. Lopez testified that he left the hospital because the leg of his scrubs was contaminated with blood, and his left sock and shoe also had blood in them. He claims that there were no other scrubs available to him at Good Samaritan. He did not check to see whether there were any scrubs available on other floors of the hospital, and he did not call anyone in the hospital to ask for clean scrubs. Dr. Feld testified that he would not have left the patient that evening. Also, he would not have left the hospital and gotten into his car with blood all over his scrubs. Additionally, he has never been in a situation where he could not access a clean pair of scrubs at the hospital and believes that most hospitals have extra scrubs for physicians. Dr. Diebel stated that hospitals normally have scrubs “everywhere”-- in the emergency room, in the main OR, in radiology, etc. He believes that Dr. Lopez could have obtained clean scrubs without having to leave the hospital that night. In his long career, Dr. Diebel never had to go home to change his scrubs. Dr. Diebel testified that Dr. Lopez violated the standard of care when he left the hospital that evening, given O.C.’s critical condition. Although O.C. was taken to the ICU, no one on the ICU team was a surgeon. Additionally, the intensivist in charge that evening was not even physically present in the hospital. Dr. Lopez should have remained at the hospital in case O.C. had to be taken back into surgery because he was her physician and the only surgeon present. Dr. Lopez maintained that pursuant to Florida Administrative Code Rule 64B8-9.007, he was permitted to delegate some of his duties to another qualified medical doctor, which is exactly what he did in this case when he left the patient in the ICU. He also noted that the anesthesiologist volunteered to stay with the patient following the surgery to monitor her recovery. Rule 64B8-9.007, which relates to Standards of Practice and Delegation of Duties, states, in pertinent part, that “the operating surgeon can delegate discretionary postoperative activities to equivalently trained licensed doctors of medicine or osteopathy … . Delegation to any health care practitioner is permitted only if the other practitioner is supervised by the operating surgeon or an equivalently trained licensed doctor of medicine or osteopathy.” Dr. Lopez testified that he appropriately delegated responsibility to the ICU intensivist and anesthesiologist. However, he also admitted that neither the intensivist, nor the anesthesiologist, was a trained surgeon who could have taken the patient back to the OR. In fact, there were no surgeons in the ICU at that time. Thus, his argument that he delegated to an equivalently trained doctor fails. The evidence is clear and convincing that Dr. Lopez fell below the standard of care by leaving the hospital while O.C. remained in critical condition. Prior Discipline At all times material to this incident, Dr. Lopez was restricted from performing any surgical procedure without a supervising physician, pursuant to a prior Board Order. The prior Board Order, related to DOH case number 2014-15022 (“2014 case”), resulted from allegations that Dr. Lopez violated the standard of care in his treatment of two obstetrics patients. The 2014 case involved two obstetrics patients who suffered complications from postpartum hemorrhage. The Administrative Complaint alleged, among other things, that Dr. Lopez committed medical malpractice by failing to timely assess, diagnose, and perform exploratory surgery. Pet. Ex. 6. As is true in this case, one of the patients in the 2014 case died. When asked about the 2014 case, Dr. Lopez was evasive and defensive. He claimed that he did not recall why his license was restricted. Then, when asked several times whether the 2014 case resulted in a patient’s death, he refused to answer directly, until prompted by the ALJ. Dr. Lopez was also disciplined by the Board in 2003, in DOH case number 2003-13635 (“2003 case”). The Administrative Complaint in that case alleged that Dr. Lopez fell below the standard of care in his performance of a uterine dilation and curettage (D&C). Specifically, the Administrative Complaint alleged that Respondent failed to perform complete evacuation of a patient’s uterus and failed to give appropriate follow-up care when the patient spontaneously expelled fetal tissue. As a result of the 2003 case, a fine of $10,000 was imposed on Dr. Lopez, and he was required to complete CMEs (continuing medical education credits) and perform community service. Despite Dr. Lopez’s history with the Board and O.C.’s death, he refused to take direct responsibility for any of his shortcomings. When asked whether he felt at all responsible for O.C.’s death, Dr. Lopez placed the blame on the ICU staff and hospital system.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order: Finding that Respondent, Berto Lopez, M.D., violated section 458.331(1)(t), Florida Statutes (2017), as charged in Petitioner’s Amended Administrative Complaint; Suspending Respondent’s license to practice medicine in the State of Florida and limiting his practice following his term of suspension as set forth in paragraph 138 above; and Imposing costs of investigation and prosecution. DONE AND ENTERED this 3rd day of December, 2020, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of December, 2020. COPIES FURNISHED: Corynn Colleen Alberto, Esquire Sarah E. Corrigan, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 (eServed) Elena Ris, Esquire 205 Chelsey Circle Alpharetta, Georgia 30004 (eServed) Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3565 (eServed) Claudia Kemp, J.D., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed)
Findings Of Fact Manatee Eye Clinic owns land adjacent to its existing offices and in close proximity to Manatee Memorial Hospital, on which it proposes to construct a freestanding ambulatory surgery center for ophthalmic surgery. On December 13, 1983, Manatee Eye Clinic filed an application for a certificate of need with the Department of Health and Rehabilitative Services (HRS) for approval of a capital expenditure in the amount of $627,640 for construction of a freestanding ambulatory surgery center for ophthalmic surgery. On April 27, 1984, Petitioner received written notice that the Department had denied the application. Manatee Eye Clinic consists of five practicing ophthalmologists in Manatee County, each of whom are [sic] duly licensed and provide quality ophthalmic care in the area. Manatee Eye Clinic, and the members thereof, have available sufficient resources, including health manpower, management personnel, as well as funds for the capital and operating expenditures for the project. Petitioner's proposed medical facility would be constructed in a sufficiently cost-effective manner and makes adequate provision for conservation of energy resources and incorporates efficient and effective methods of construction. Should this certificate of need be granted, Manatee Eye Clinic will accept Medicaid, Medicare, third-party pay, private pay, and charity care. The relevant service area for the proposed facility is Manatee County. The five ophthalmologists at MEC perform approximately 1,200 eye surgeries per year involving cataract removal and lens implant. At present all of these surgeries are performed at Manatee Memorial Hospital. The founder of MEC, Dr. Robert E. King, has twice served as chief of surgery at Manatee Memorial. He is presently a director on the board of directors of the company that recently purchased Manatee Memorial Hospital and removed it from its former status of a not-for-profit hospital to its current status as a for-profit hospital. If this application is granted, Manatee Memorial Hospital will lose all of these patients. Cataract eye surgery, as it is performed today, is ideally performed in an outpatient surgery setting. The five ophthalmologists currently perform an additional 600 outpatient surgical procedures per year in the existing clinic. These procedures would be performed in the freestanding surgery facility if this application is approved. Manatee Memorial Hospital is located one city block from MEC. L. W. Blake Memorial Hospital, some seven miles from MEC, has five operating rooms available for outpatient surgery but is not currently used by any of the doctors at MEC. Additionally, Ambulatory Surgical Center/Bradenton was licensed in December, 1982. This facility has not been used by MEC doctors. During the latest reporting period, 1983/1984, Manatee County and the Ambulatory Surgery Center performed the following procedures; Hospital Inpatient Outpatient Total L. W. Blake Memorial Hospital 8,800 2,752 11,552 Manatee Memorial Hospital 6,766 1,654 8,420 Ambulatory Surgery Center -- 1,525 1,525 TOTALS 15,566 5,931 21,497 (Exhibit 19) There is no shortage of operating rooms in Manatee County available for outpatient surgery. Petitioner's primary argument against using the operating rooms at Manatee Memorial Hospital are: operating room nurses are rotated and this results in nurses not being as well qualified as they would be if their duties were limited to ophthalmic surgery; eye surgery is generally elective and such surgery may be bumped from a scheduled operation by emergency general surgery; the patients are generally older than 65 and are less comfortable in hospital surroundings than they would be at an outpatient surgical facility; access to the ambulatory surgical center would be easier for these elderly patients than is access to the existing hospitals for the same outpatient surgery; the hospital charges for the outpatient surgery are approximately twice the charges proposed by Petitioner; and Medicare will pay 100 percent of the charges in a freestanding surgical facility (up to a maximum) but only pays 80 percent in a hospital setting, thereby making the use of a freestanding facility cheaper for the patient and for Medicare. MEC doctors currently use their own scrub nurses during eye surgeries performed at Manatee Memorial Hospital leaving only the circulating nurse to be provided by the hospital. No incident was cited wherein one of Petitioner's patients was "bumped" from a scheduled operation. The complication rate for cataract surgery has dropped from 10 percent to 0.1 percent in recent years as surgical procedures have improved. As proposed, the partnership owning MEC will erect and own the surgery center, will lease the equipment, most of which is presently owned by MEC, to the Petitioner; and the rent for the building will be a fixed amount per month plus 50 percent of the net operating profits of Petitioner. Proposed charges by the freestanding surgery center will be $904 per patient (for cataract removal and lens implant) This does not include the surgeon's fee. There are no methodology rules to determine need for a freestanding outpatient surgery facility. DHRS has consistently determined need for ambulatory surgery centers by taking the most recent number of surgical procedures performed in all inpatient and outpatient facilities in the county and dividing it by the county's base population for the latest year, here 1983. This gives the rate of surgeries per 1,000 population for the latest year for which statistics are available and is projected forward to the second year of operation (here 1987). The same is done for outpatient surgeries. DHRS uses the figure of 29 as the percentage of surgeries that can be performed in an outpatient setting to determine the need for outpatient surgery facilities in 1987. From this is subtracted the number expected to be performed in existing hospital and freestanding outpatient facilities to determine net need through 1987 for freestanding outpatient facilities. Applying this procedure, to which Petitioner generally concurs, except for the 29 percent factor, the following need is shown. The 1983 population of Manatee County is 162,997. 21,497 surgeries performed in 1983 x 1000 4 162,997 131.9 surgeries per 1000 population. The 1987 projected population of Manatee County is 182, 120. Multiplying this population by 131.9 per 1000 equals 24,061 surgeries expected to be performed in Manatee County in 1987. HRS estimates that 29 percent of these surgeries could be performed in an outpatient setting in 1987. Multiplying 24,051 by .29 equals 6,978 outpatient procedures possible. In 1983 there were 4,406 outpatient surgeries performed in a hospital setting in Manatee for a rate per thousand of 27. Multiplying this rate by the projected population for 1987 yields 4,931 outpatient surgeries that can be performed in a hospital setting in 1987. Subtracting from this number the projected outpatient surgeries to be performed in a hospital setting in 1987 (6,978 - 4,931) shows 2,047 to be performed in a freestanding facility. Ambulatory Surgery Center performed 1,525 procedures from June, 1983, to May, 1984. When this is projected to 1987, Ambulatory Surgery Center is expected to perform 1,715 surgical procedures. Substracting this from 2,047 leaves 332 procedures as a net need through 1987. This is below the pro forma break-even point of Petitioner and indicates the project is not financially possible. The 29 percent factor was obtained from American Hospital Association report of 1981. In 1981, 18 percent of the total surgeries were done on an outpatient basis while it was estimated that 20 to 40 percent of all surgeries could be performed on an outpatient basis. DHRS averaged the 18 percent and the maximum of 40 percent to arrive a mean of 29 percent to project need for outpatient surgery facilities. The latest figures from the American Hospital Association report is for 1982 and this shows the latest percentage of surgeries performed on an outpatient basis to be 20.8 percent. If this figure is averaged with 40 percent, the mean would rise to 30.4 percent. This is the percentage Petitioner contends should be used. Using this figure, the outpatient surgeries possible in 1987 would rise to 7,315 and a need for 669 procedures would exist in 1987. This would meet the higher break-even number presented by Respondent of 556 procedures for the second year of operation. It is noted that the experts' estimated surgical procedures that could be performed in an outpatient setting varied from 20 to 40 percent. In arriving at the 29 percent used DHRS averaged the latest actual percentages available in 1981 with 40 percent to obtain an arbitrary figure of 29 percent to use in calculating need for outpatient facilities. It is further noted that between June of 1983 and May Of 1984 Manatee Memorial Hospital performed 1,654 outpatient surgery procedures and 6,766 inpatient surgery procedures (Exhibit 14) and Blake Memorial Hospital performed 2,752 outpatient surgery procedures and 8,800 inpatient surgery procedures (Exhibit 15). Accordingly, 23.8 percent of Blake's surgery procedures are done as outpatient surgery and 19.6 percent of the surgeries performed at Manatee Memorial Hospital are done as outpatient surgeries. If the 1,200 outpatient surgeries per year performed at Manatee Memorial Hospital by MEC had been removed during this period, the percentage of outpatient surgery would have been reduced to 6.3 percent for Manatee Memorial Hospital. No evidence was presented regarding the number of ophthalmic surgeries that were performed at Blake Memorial Hospital during this period. Regardless of the potential loss of outpatient surgery cases at Blake if this application is granted, the percentage of outpatient surgeries performed in a hospital setting in Manatee County is, according to the latest data available, 22.1 percent (combining Blake and Manatee Memorial). Using 29 percent of the total surgeries projected for 1987 in Manatee County to obtain an estimate of the outpatient surgery that can be expected to be performed in a hospital setting in 1987 results in a much higher figure than the current growth rate in outpatient surgeries would suggest. Accordingly, I find a 29 percent factor more credible than a higher percentage would be in forecasting need for outpatient surgical facilities in 1987. This conclusion is further supported by the fact that most ophthalmic surgery today is performed in an outpatient setting. This was not true only a few years ago. Accordingly, there can be little additional growth resulting from ophthalmic surgery procedures going from inpatient to outpatient procedures. As a consequence, future growth in outpatient surgery must come from other surgical procedures.
