The Issue The issues in this case are set forth in 11 separate counts within the four consolidated cases: Case No. 09-5360 Count I--Whether Respondent failed to properly monitor and care for a patient in restraints. Count II--Whether Respondent failed to ensure the physician's plan of care for patient was implemented. Case No. 09-5363 Count I--Whether Respondent failed to properly implement the physician's plan of care for patient. Case No. 09-5364 Count I--Whether Respondent failed to ensure a patients' right to privacy. Count II--Whether Respondent failed to ensure that food was served in the prescribed safe temperature zone. Count III--Whether Respondent failed to ensure that only authorized personnel had access to locked areas where medications were stored. Count IV--Whether Respondent failed to perform proper nursing assessments of a patient. Count V--Dismissed. Count VI--Whether Respondent failed to maintain patient care equipment in a safe operating condition. Case No. 09-5365 Count I--Whether Respondent failed to triage a patient with stroke-like symptoms in a timely fashion. Count II--Whether Respondent's nursing staff failed to assess and intervene for patients or ensure implementation of the physician's plan of care.
Findings Of Fact Petitioner is the state agency responsible for, inter alia, monitoring health care facilities in the state to ensure compliance with all governing statutes, rules and regulations. It is the responsibility of AHCA to regularly inspect facilities upon unannounced visits. Often AHCA will inspect facilities for the purpose of licensure renewal, certification, or in conjunction with federal surveys. AHCA will also inspect facilities on the basis of complaints filed by members of the general public. Respondent, Gulf Coast Medical Center ("Gulf Coast" or "GCH") is a hospital within the Lee Memorial Health System. South West Florida Regional Medical Center ("SWF") was another hospital within the Lee Memorial Health System. SWF closed in March 2009, when it was consolidated with Gulf Coast. On October 15, 2008, the Agency conducted a complaint investigation at SWF; a follow-up complaint investigation was done on November 13, 2008. SWF filed and implemented a plan of correction for the issues raised in each of the investigations. The November investigation resulted in an Administrative Complaint containing two counts. On December 16, 2008, AHCA performed another complaint investigation at Gulf Coast. Gulf Coast filed and implemented a plan of correction for the issues raised in the investigation. The investigation resulted in an Administrative Complaint containing one count. On January 5 through 9, 2009, AHCA conducted a routine licensure survey at Gulf Coast. The hospital filed and implemented a plan of correction for the issues raised in the survey. The survey resulted in an Administrative Complaint containing six counts (although Count V was dismissed during the course of the final hearing). On February 18, 2009, AHCA did its follow-up survey to the previous licensure survey. Gulf Coast filed and implemented a plan of correction for the issues raised in the survey. The survey resulted in an Administrative Complaint containing two counts. Case 09-5360 The complaint investigation at SWF on November 13, 2008, was conducted under the supervision of Charlene Fisher. Count I in this case addresses findings by the Agency concerning a patient who was placed in restraints at the hospital on August 28, 2008. The patient, A.D., came into the hospital emergency department under the Baker Act seeking medical clearance to a facility. The patient presented at approximately 4:00 p.m., with back pain. He had a history of drug abuse, so there was concern by the hospital regarding the use of narcotics or certain other medications to treat the patient. The patient engaged in some scuffling with police. A physician signed and dated a four-point restraint (one on each limb) order, resulting in the patient being physically restrained. The restraint was deemed a medical/surgical restraint, rather than a behavioral restraint. AHCA had concerns about the restraint, specifically whether there was a notation for Q 15 (or every 15 minutes) monitoring of the restrained patient. However, medical/surgical restraints only require monitoring every two hours. The restraint worksheet for the patient confirms monitoring every two hours. The patient was ultimately admitted to the hospital at 9:37 p.m., and, thereafter, began complaining of left shoulder pain. The hospital responded to the patient's complaints about back pain and began treating the pain with analgesics. However, the patient continued to complain about the pain. An X-ray of the patient's shoulder was finally done the next morning. Shoulder dislocation was confirmed by the X-ray, and the hospital (four hours later) began a more substantive regimen of treatment for pain. Surgery occurred the following morning, and the shoulder problem was resolved. It is clear the patient had a shoulder injury, but it is unclear as to when that injury became more painful than the back injury with which the patient had initially presented. The evidence is unclear whether or when the shoulder injury became obvious to hospital staff. During its course of treating this patient, the hospital provided Motrin, Tylenol, Morphine, Percocet and other medications to treat the patient's pain. Count II in this case also involved a restrained patient, M.D., who had presented to the emergency department under the Baker Act. The patient was released from handcuffs upon arrival at the hospital. After subsequently fighting with a deputy, this patient was also placed in a medical/surgical restraint pursuant to a physician's order. The doctor signed and dated, but did not put a time on, the restraint order. A time is important because there are monitoring requirements for patients in restraints. However, the time of 0050 (12:50 a.m.) appears on the patient's chart and is the approximate time the restraints were initiated. The proper procedure is to monitor a restrained patient every two hours. This patient, however, was removed from his restraints prior to the end of the first two-hour period. Thus, there are no records of monitoring for the patient (nor would any be necessary). The evidence presented by AHCA was insufficient to establish definitively whether the hospital nursing staff failed to properly respond to the aforementioned patients' needs. It is clear the patients could have received more care, but there is not enough evidence to prove the care provided was inadequate. Case No. 09-5363 On December 16, 2008, AHCA conducted a complaint investigation at SWF. The Agency had received a complaint that the hospital did not properly implement a physician's plan of care. Count I in this complaint addresses alleged errors relating to two of four patients reviewed by the surveyors. Both of the patients came to the hospital from a nursing home. One patient, I.A., had presented to the emergency department complaining of chest pains. The medication list sent to the hospital by the nursing home for I.A. actually belonged to someone other than I.A. I.A.'s name was not on the medication list. The drugs listed on the patient chart were different than the drugs I.A. had been taking at the skilled nursing facility from which she came. The skilled nursing facility actually sent I.A.'s roommate's medication list. The erroneous medications were then ordered by the admitting physician and administered to the patient. The hospital is supposed to review the medication list it receives and then enter the medications into the hospital system. The person reviewing the medication list does not necessarily have to be a nurse, and there is no evidence that the person making the error in this case was a nurse or was some other employee. It is clear, however, that the person reviewing the medication list did not properly ascertain that the list belonged to patient I.A. The other patient from the nursing home had been admitted for surgery at SWF. Again, the nursing home from whence she came sent a medication list that was incorrect. The medications on the incorrect list were entered into the system by a SWF employee. The erroneous medications were ultimately ordered by the attending physician for the patient, but there is no evidence the patient was ever administered those medications. Neither of the residents was harmed by the incorrect medications as far as could be determined. Case 09-5364 From January 5 through 8, 2009, AHCA conducted a licensure survey at Gulf Coast and SWF in conjunction with a federal certification survey. Count I of the complaint resulting from this survey addressed the right of privacy for two residents. In one instance, a patient was observed in her bed with her breasts exposed to plain view. In the other instance, a patient's personal records were found in a "public" place, i.e., hanging on the rail of a hallway in the hospital. AHCA's surveyor, Nancy Furdell, saw a female patient who was apparently asleep lying in her bed. The patient's breasts were exposed as she slept. Furdell observed this fact at approximately 1:15 p.m., on January 7, 2009. Furdell did not see a Posey vest on the patient. She did not know if anyone else saw the exposed breasts. Furdell continued with her survey duties, and at approximately 5:00 p.m., notified a staff member as to what she had seen. Furdell did not attempt to cover the patient or wake the patient to tell her to cover up. The female patient with exposed breasts was in the intensive care unit (ICU) of the hospital. Visiting hours in ICU at that time were 10:00 to 10:30 a.m., and again from 2:00 till 2:30 p.m. Thus, at the time Furdell was present, no outside visitors would have been in the ICU. ICU patients are checked on by nursing staff every half-hour to an hour, depending on their needs. This particular patient would be visited more frequently due to her medical condition. On the day in question, the patient was supposed to be wearing a Posey vest in an effort to stop the patient from removing her tubing. The patient had been agitated and very restless earlier, necessitating the Posey vest. Also on January 7, 2009, a surveyor observed some "papers" rolled up and stuffed inside a hand-rail in the hospital corridor. This occurred at 1:15 p.m., on the fourth floor of the south wing of the hospital. A review of the papers revealed them to be patient records for a patient on that floor. The surveyor could not state at final hearing whether there were hospital personnel in the vicinity of the handrail where she found the patient records, nor could she say how long the patient records had been in the handrail. Rather, the evidence is simply that the records were seen in the handrail and were not in anyone's possession at that moment in time. Count II of the complaint was concerned with the temperature of certain foods being prepared for distribution to patients. Foods for patients are supposed to be kept at certain required temperatures. There is a "danger zone" for foods which starts at 40 degrees Fahrenheit and ends at 141 degrees Fahrenheit. Temperature, along with time, food and environment, is an important factor in preventing contamination of food and the development of bacteria. Surveyor Mary Ruth Pinto took part in the survey. As part of her duties, she asked hospital staff to measure the temperature of foods on the serving line. She found some peaches at 44 degrees, yogurt at 50 degrees, and cranberry juice at 66 degrees Fahrenheit. According to Pinto, the hospital's refrigerator temperatures were appropriate, so it was only food out on the line that was at issue. Pinto remembers talking to the hospital dietary manager and remembers the dietary manager agreeing to destroy the aforementioned food items. The hospital policies and procedures in place on the date of the survey were consistent with the U.S. Food and Drug Administration Food Code concerning the storage, handling and serving of food. The policies acknowledge the danger zone for foods, but allow foods to stay within the danger zone for up to four hours. In the case of the peaches and yogurt, neither had been in the danger zone for very long (not more than two hours). The cranberry juice was "shelf stable," meaning that it could be stored at room temperature. The food services director for the hospital remembers the peaches and yogurt being re-chilled in a chill blaster. She does not believe any of the food was destroyed. Count III of the complaint addressed whether an unauthorized person had access to a room where medications were being stored. A state surveyor, Gary Furdell, was part of the survey team on January 5, 2009. Furdell was touring the second floor of the hospital when he noticed a locked door. Furdell asked a hospital medical technician who was standing nearby about the door. The medical technician gave Furdell the code to unlock the door. Furdell peeked inside and noticed bottles that he presumed were medications. It would be a violation for a medical technician to have access to medications, because medical technicians cannot distribute drugs. The room Furdell looked into is a "mixed use" room located behind a nursing station. A mixed use room is used to store medical supplies, including medications, as long as there is a locked cabinet in the room for that purpose. This particular mixed use room had a locked cabinet. The room is used for the preparation of medications and for other purposes. No narcotics were stored in this particular mixed use room. The room contained locked cabinets used to store other medications. The evidence presented was insufficient to determine what "medications" Furdell may have seen in the room. Count IV of the complaint concerned the nursing assessment of a patient, and whether the assessment was properly and timely performed. A patient, M.S., had been admitted to the hospital on June 18, 2008, for lung surgery. Following the surgery, Amiodarone (a very toxic drug which can cause clots and other complications) was administered to treat M.S. for heart arrhythmia. The Amiodarone was administered intravenously and M.S. developed blisters and irritation at the intravenous site. That is not an uncommon complication with Amiodarone. M.S.'s attending physician was notified about the irritation and prescribed a treatment. He also ordered a consult with an infectious disease specialist who ultimately changed M.S.'s antibiotics. Although M.S. was seen daily by her physicians, the nursing notes do not reflect the assessment and treatment of her blisters. It appears that proper care was rendered, but the care was not documented properly. Another patient was admitted to the hospital on December 15, 2008, with End Stage Renal Disease and diabetes mellitus for which she began dialysis treatment. The patient was not weighed before and after a particular dialysis treatment on January 5, 2009. However, the patient had been moved to an air mattress bed on that date for comfort. The air mattress bed did not allow for a weight to be taken as it could be on a regular bed. There is an allegation in the Administrative Complaint concerning the discontinuation of the calorie count for a patient. This issue was not discussed in AHCA's Proposed Recommended Order, nor was sufficient evidence of any wrong- doing concerning this matter presented at final hearing. During the survey, the hospital was found to be storing the medication Mannitol in blanket warmers, rather than in warmers specifically designed for the drug. The blanket warmers maintained the Mannitol at 100-to-110 degrees Fahrenheit. The manufacturer's label on the drug calls for it to be dispensed (injected) at between 86 and 98.5 degrees Fahrenheit. In order to meet this requirement, the hospital takes the drug out of the blanket warmer in time for it to cool sufficiently before it is injected. There is nothing inherently wrong with using a blanket warmer to store Mannitol. On January 5, 2009, a surveyor found two vials of Thrombin, one vial of half-percent Lidocaine and Epi, and one vial of Bacitracin in operating room No. 4. The operating room is within the secured and locked suite of surgical rooms on the second floor. Two of the vials had syringes stuck in them and one of them was spiked. Whoever had mixed the medications was not attending to them at the time the surveyor made her observation. There were two unlicensed technicians in the room preparing for the next surgery. A registered nurse anesthetist was present as well. There was no identifying patient information on the medications. The hospital's policies and procedures do not require the patient's name to be on the label of medications prepared for impending surgery. That is because the procedures for the operating room include a process for ensuring that only the correct patient can be in the designated operating room. There is a fail-safe process for ensuring that only the proper patient can receive the medications that are set out. At around 2:45 p.m. on January 5, 2009, there were patient records in the emergency department showing that several drugs had been administered to a patient. The surveyor did not see a written order signed by a physician authorizing the drugs. When the surveyor returned the next morning, the order had been signed by the physician. The hospital policy is that such orders may be carried out in the emergency department without a doctor's signature, but that a physician must sign the order before the end of their shift. AHCA cannot say whether the physician signed the order at the end of his shift or early the next day. Count V of the complaint was voluntarily dismissed by the Agency. Count VI of the complaint concerned the status of certain patient care equipment, and whether such equipment was being maintained in a safe operating condition. A patient was weighed at the hospital upon admission on December 27, 2008, and found to weigh 130 pounds using a bed scale. Six days later, on January 2, 2009, the patient's weight was recorded as 134 pounds. Two days later, in the same unit, the patient weighed 147 pounds and the next day was recorded as weighing 166 pounds. During the survey process, the patient was weighed and recorded at 123 pounds on a chair scale. The hospital does not dispute the weights which were recorded, but suggests there are many factors other than calibration of the equipment that could explain the discrepant weights. For example, the AHCA surveyor could not say whether the patient sometimes had necessary medical equipment on his bed while being weighed, whether different beds were involved, or whether any other factors existed. AHCA relies solely on the weight records of this single patient to conclude that the hospital scales were inaccurate. Case No. 09-5365 On February 18, 2009, AHCA conducted a licensure survey at Gulf Coast. Count I of the complaint from this survey concerned the timeliness of triage for a patient who presented at the hospital emergency department with stroke-like symptoms. AHCA surveyors witnessed two patients on stretchers in the ambulance entrance hallway leading to the emergency department. Each of the two patients had been brought in by a separate emergency medical service (EMS) team and was awaiting triage. One patient was taken to an emergency department room (ER room) 50 minutes after his/her arrival at the hospital. The other patient waited 45 minutes after arrival before being admitted to an ER room. Meanwhile, a third patient arrived at 2:20 p.m., and was awaiting triage 25 minutes later. During their observation, the surveyors saw several nursing staff in the desk area of the emergency department, i.e., they did not appear to be performing triage duties. The emergency department on that date was quite busy. That is not unusual during February, as census tends to rise during the winter months due to the influx of seasonal residents. A summary of the action within the emergency department from 1:00 p.m. to 3:00 p.m., on the day of the survey shows the following: Patient L.G., 74 years old with stable vital signs, was radioed in by her EMS team at 1:08; L.G. was processed into the ER at 1:21 (which is not an unreasonable time; EMS teams call in when they arrive at or near the hospital. By the time they gain access, wait their turn if multiple ambulances are present, and get the patient inside, several minutes may lapse). L.G. was stabilized and quickly reviewed by ER staff, then officially triaged at 2:04. Patient H.M., an 89-year-old male residing in a nursing home, arrived at 1:20 and was processed in at 1:59. He was triaged at 2:01, but ultimately signed out of the hospital against medical advice. Patient E.M. arrived at 2:18 and was processed at 2:25. Triage occurred one minute later. This patient presented as a stroke alert, and hospital protocol for that type patient was followed. Patient C.J. arrived at 1:08 and was processed at 2:38. Triage occurred immediately after C.J. was processed. This patient was not stroke alert, but had some stroke-like symptoms.1 C.J. had not been transported to the hospital as emergent, because the symptoms had been going on for 24 hours. Patient W.M., an auto accident victim, arrived at 1:40 and was processed at 1:49. Triage occurred within six minutes. Patient M.M., W.M.'s wife (who had been with M.M. in the automobile accident, but was placed in a separate ambulance), arrived at 2:06 and was triaged at 2:34. There is no record of when M.M. was processed. Patient L.M. came to the hospital from a nursing home. She arrived at 1:43 and was processed at 2:35. L.M. was triaged at 2:37. Patient K.M. arrived at 2:45 and was processed within three minutes. Triage occurred at 2:52. Her triage was done very quickly due to the condition in which she arrived, i.e., shortness of breath and low oxygen saturation. Patient R.S. arrived at 1:00 and was triaged at 1:15. The aforementioned patients represent the patients presenting to the emergency department by ambulance during a two-hour period on a very busy day. It is the customary procedure for ER staff to make a quick visual review (rapid triage) of patients as they come into the hospital. Those with obvious distress or life-threatening conditions are officially triaged first. Others, as long as they are stable, are allowed to wait until staff is available for them. As part of their duties, nurses necessarily have to be in the desk area (nursing station) in order to field phone calls from physicians concerning treatment of the patients who present. It is not unusual or improper for nurses to be in the nursing station while residents are waiting in the processing area. It is clear that some patients waited a much longer time for triage than others. However, without a complete record of all patients who presented that day and a complete review of each of their conditions, it is impossible to say whether the hospital was dilatory in triaging any of them. Count II of the complaint addressed the nursing staff and whether it failed to assess and intervene in the care of a patient or failed to implement a physician's plan of care for the patient. Patient D.W. was a 67-year-old female who was morbidly obese, diabetic, debilitated, had end stage renal disease, and was receiving dialysis. Upon admission, D.W. had a Stage 3 pressure ulcer to her sacrum and a Stage 4 ulcer on her left calf. A wound care protocol was initiated immediately, and a Clinitron bed was obtained for her on the day of admission. Due to the seriousness of her condition, the wound care physician declined to accept her case at first. He later ordered Panafil, and it became part of the protocol for treating the patient. The nursing documentation for D.W. was only minimally sufficient, but it does indicate that care was provided. Patient R.H. was an 83-year-old male who presented on February 10, 2009, in critical condition. R.H. was suffering from congestive heart failure, pneumonia, and respiratory failure. Due to the critical nature of his respiratory problems, R.H. was placed on a ventilator. As a ventilator patient, he did not fit the profile for obtaining wound care. Nonetheless, the hospital implemented various other measures to deal with R.H.'s pressure wounds.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by Petitioner, Agency for Health Care Administration, imposing a fine in the amount of $500.00 in DOAH Case No. 09-5363 and a fine in the amount of $500.00 in DOAH Case No. 09-5364, Count VI. DONE AND ENTERED this 30th day of April, 2010, in Tallahassee, Leon County, Florida. R. BRUCE MCKIBBEN 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 30th day of April, 2010.
The Issue The issue is whether Respondent's medical license should be disciplined for alleged violations of Chapter 458, Florida Statutes.
Findings Of Fact Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0027368. Respondent is board certified in family practice; however, he is not board certified in emergency medicine. On May 30, 1994, Dr. Dulay was on call in the hospital emergency room at Madison County Memorial Hospital (MCMH) in Madison, Florida. On May 30, 1994, Patient T.H. an obese, forty-eight year-old male was found unconscious on the floor of the bathroom by his brother, Wallace. T.H. had an arteriovenous malformation (AVM) in his brain. An AVM is a weakened area of a blood vessel which can fill with blood, expand and/or burst. AVMs located in the brain are very dangerous since a ruptured AVM can damage the brains tissue. The amount of damage depends on the amount and rapidity of the bleeding. Under any circumstances, a ruptured AVM is an emergency medical condition where time is of the essence in diagnosing and treating usually with some neurosurgical intervention. On May 30, 1994, at approximately 4:56 a.m., Carol Wells a Madison County 911 Operator received an emergency call regarding T.H. The call was originally received as a fall. An Advanced Life Support (ALS) ambulance was dispatched to T.H.'s location in Cherry Lake Garden Trailer Park. An ALS unit is intended to be a mobile critical care unit, able to render critical care and stabilization to a patient enroute to an appropriate hospital. An Advanced Life Support unit contains equipment needed for insertion of a chest tube, a lab, and an x-ray, as well as equipment and medications for cardiac emergencies. The equipment and medications needed for T.H.'s case were present. The ALS unit arrived at T.H.'s location at 5:19 a.m. Jimmy Kent was an EMT and driver of the ALS unit that responded to the 911 emergency call on T.H. Richard Kline was the paramedic on the ambulance. Mr. Kline was trained in ALS care and could administer certain drugs, including Procardia without a physician's order. Paramedic Kline found patient T.H. on the floor of the trailer. He observed T.H. to be comatose, unresponsive to painful stimuli, and exhibiting snoring-type respirations. His skin was hot and dry, and his face was red. T.H. scored a three on the Glasgow Coma Scale, the lowest possible score. T.H.'s vital signs were blood pressure estimated at 300 plus over 150, respiratory rate of 40, heart rate "tacking" at approximately 170, with raspy breathing. T.H. was considered in critical condition. At the scene, Paramedic Kline was having problems with his cardiac monitor, which became non-functional due to battery problems. However, patient T.H. could still be adequately monitored manually. Additionally, within twenty-five minutes of beginning the run, the cardiac monitor on the ALS unit was non- functional due to failure of the primary and back-up batteries. The lack of the units equipment did not significantly impact the paramedic's ability to monitor or treat T.H.'s condition. Paramedic Kline was informed by T.H.'s family that he had a history of Arterial Venous Malformation, paralysis on the right side, and strokes. T.H.'s sister was called and she advised that T.H. not be brought to Madison County Memorial Hospital (MCMH) because they usually don't have a doctor available. She wanted T.H. to go to South Georgia Medical Center (SGMC) in Valdosta, Georgia. The paramedic thought that they needed to take T.H. to MCMH because of the serious vital statistics that T.H. had. The paramedic felt T.H. could go into cardiac arrest. After being advised by the paramedic that T.H. needed immediate assistance at MCMH, T.H.'s sister agreed to have T.H. taken to MCMH. There are two hospital emergency facilities to choose from when transporting an emergency case in the Madison, Florida, area, MCMH and SGMC. In driving terms MCMH is slightly, but not significantly, closer to Cherry Lake Garden Trailer Park than SGMC. However, the facilities are very different in the services each can offer in an emergency situation. MCMH is not a trauma center. MCMH does not have any neurosurgical facilities, neurosurgical consults, diagnostic MRI's, diagnostic CT scans, or cerebral monitoring equipment available. MCMH cannot treat a cerebral vascular accident or bleeding in the brain. On the other hand, SGMC is a tertiary care facility. It has neurosurgical facilities, neurosurgical consults, diagnostic CT scans, and cerebral monitoring equipment available. SGMC can treat a cerebral vascular accident and is the closest facility which can provide such care. The ambulance was en route to MCMH when it contacted the hospital by radio; Joanie Cruce, R.N., spoke to the ambulance driver over the radio. Paramedic Kline informed Nurse Cruce of T.H.'s history, including the presence of T.H.'s AVM and vital signs. He also informed Nurse Cruce that he was bringing the T.H. to MCMH. Nurse Cruce relayed T.H.'s information to Joe Jaime, R.N. Nurse Jaimie was on the telephone to Dr. Dulay who was in another room at the hospital. Nurse Jaimie relayed over the telephone to Dr. Dulay the information Nurse Cruce gave her. At no time did Dr. Dulay speak directly with the paramedic. Dr. Dulay was informed that the patient had high blood pressure, was unconscious, and had a history that included an arterial venous malformation. Due to the patient being unconscious, he suspected a cerebral vascular accident/stroke (CVA). At approximately 5:40 a.m., while en route to MCMH, the paramedic asked for advice on whether to administer Procardia. Procardia is used to reduce blood pressure. Respondent advised that it was appropriate to administer 10mg of Procardia. There was some uncertainty in the testimony as to whether the administration of Procardia was requested by the paramedic and approved by Dr. Dulay, or ordered by Dr. Dulay. Either person could have authorized the use of the drug. In any event, 10mg of Procardia was the appropriate medication for the patient's condition and met or exceeded the appropriate standard of care for an emergency room physician under the circumstances. At some point, Dr. Dulay advised the ambulance to have T.H. taken to the nearest appropriate facility. The ALS unit was one to two miles from MCMH when Joanie Cruce, R.N., advised the ambulance driver to take T.H. to the nearest appropriate facility. Either Nurse Cruce misspoke and said Tallahassee or Richard Kline misunderstood her to say Tallahassee. Richard Kline questioned the direction to take T.H. to Tallahassee. He told nurse Cruce that the family wanted T.H. to go to the hospital in Valdosta. The information was passed to Dr. Dulay. He agreed that SGMC was an appropriate facility for T.H. and in fact SGMC was the closest appropriate facility for T.H.'s condition. Dr. Dulay never informed the nursing staff that T.H. could not be brought to MCMH and indeed the nurses thought that the ambulance was on its way even after the conversation about Valdosta. Patient T.H. was not in respiratory or cardiac arrest at the time the ambulance was turned around to go to Valdosta. After the change of direction, which is always within the discretion of the ambulance crew, there was no further contact with MCMH. Therefore Dr. Dulay was never informed of the results of the Procardia. Additionally, T.H. was never admitted to MCMH and never became a patient of Dr. Dulay or the hospital. Therefore, since T.H. was not a patient of the hospital no transfer from one facility to another facility occurred. While en route to SGMC, the ambulance contacted SGMC's emergency room. The staff advised the paramedic to give T.H. sodium nitroprusside. However, the ambulance did not carry sodium nitroprusside. Instead the paramedic was advised by SGMC staff to administer Lasix IV and nitroglycerine. Patient T.H. suffered respiratory arrest just outside the city limits of Valdosta. Efforts to intubate and revive him were unsuccessful. Patient T.H. arrived at SGMC in full arrest. The ambulance arrived at SGMC at 6:25 a.m. Attempts to revive the patient at the hospital were unsuccessful. T.H. was pronounced deceased shortly after his arrival at SGMC. T.H.'s cause of death was cardiopulmonary arrest with an underlying cause of intracranial hemorrhage, probably due to an aneurysm. In short, all of T.H.'s symptoms were caused by a rapidly expanding and bleeding cerebral vascular incident from his AVM. T.H.'s condition was not due to a cardiac problem. The medical condition of T.H. at the time he was transported by Madison County ALS was indicative of an intracranial hemorrhage. Such a condition could only be evaluated for surgical treatment through the utilization of an MRI and CT scan, and required the immediate consultation of a neurosurgeon. None of which were available at MCMH. Moreover, it would generally be preferable to transport a patient with a score of three on the Glasgow Coma Scale to a trauma center. SGMC was the closet facility to Cherry Lake at which a neurosurgical consult was available, and which had the capability of treating an intracranial hemorrahage; therefore, patient T.H. was appropriately diverted to that facility. Dr. Dulay did not open a chart on T.H., and could not recall whether he made written notes during T.H.'s emergency. However, it is not customary practice that a medical chart be opened for an emergency case when consults are made via radio and the person is diverted or otherwise delivered to a separate facility. Generally, neither the hospital nor the doctor know the name of the person being transported. If the person does not arrive at the hospital, that facility has no information on which to open a patient record. Under such circumstances, the person's history, vital signs, and medication administration are recorded in the ALS run sheet, which accompanies the person to his or her ultimate destination. The radio communications are recorded by audiotape. In this case, the history, vital signs, and medication administration to T.H. were in fact recorded in the ALS run sheet. The run sheet appropriately accompanied T.H. to SGMC. The radio communications were recorded by audiotape. These documents are adequate records in emergency situations. Given these facts, there was no deviation by Dr. Aldolfo Dulay from the applicable standard of care for a physician under the circumstances presented in this case or that there was a failure to keep adequate written medical records justifying the course of treatment of the patient.
Recommendation Based upon the findings of fact and conclusions of law, it is, RECOMMENDED: That the Board of Medicine enter a final order finding that Adolofo Dulay, M.D. did not practice below the accepted standard of care in his handling of the diversion of patient T.H. to a tertiary care facility, that there was no transfer of patient T.H. and that the records maintained were appropriate under the circumstances and that the Administrative Complaint be dismissed. DONE AND ENTERED this 2nd day of June, 1998, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of June, 1998. COPIES FURNISHED: John Terrell, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Richard B. Collins, Esquire Ryan Garrett, Esquire Collins and Truett, P.A. 2804 Remington Green Circle, Suite 4 Tallahassee, Florida 32308 Angela T. Hall, Agency Clerk Department of Health Building 6, Room 136 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Pete Peterson, Esquire Department of Health Building 6, Room 102-E 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Dr. James Howell, Secretary Department of Health Building 6, Room 306 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Dr. Marm Harris, Executive Director Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether proposed rules 59B-15.001 through 59B-15.007 are an invalid exercise of delegated legislative authority.
Findings Of Fact The State Center for Health Statistics (State Center) within the Agency collects and disseminates data from hospitals and ambulatory surgery centers. One of the responsibilities of the State Center is to produce comparable and uniform health information and statistics through a Comprehensive Health Information System. § 408.05(3), Fla. Stat. The State Comprehensive Health Information System Advisory Council (CHIS) is established within the Agency to assist the State Center in reviewing the Comprehensive Health Information System and to recommend improvements for the system. § 408.05(8), Fla. Stat. In conjunction with CHIS, the agency is to develop and implement a long-range plan for making available performance outcome and financial data that will allow consumers to compare health services. § 408.05(3)(l), Fla. Stat. In 2004, Section 408.061, Florida Statutes, was amended to require health care facilities to submit hospital emergency department data, data on hospital-acquired infections as specified by rule, and data on readmissions as specified by rule. On October 20, 2004, a meeting of CHIS was held, and a discussion was held on the collection and dissemination of data relating to infection rates. A motion was approved to consider the adoption of Surgical Infection Prevention (SIP) measures and to form a Technical Workgroup for Hospital Acquired Infections (Technical Workgroup) to make recommendations to the Agency on how to report SIP measures, to review the current systems of reporting infection rates, and to determine the appropriate infection measures to report. On December 1, 2004, CHIS met and heard recommendations from the Technical Workgroup concerning the collection and reporting of SIP measures. The recommendations included developing draft rules. The agency assigned Carolyn Turner, a Government Analyst II with the Agency, to draft rules relating to the collection of SIP Measures. Ms. Turner began drafting the rules in December 2004. Ms. Turner drafted the Proposed Rules. On January 13, 2005, the Agency held a rule development workshop, which had been noticed in the Florida Administrative Weekly on December 30, 2004. During the workshop and subsequent to the workshop, the Agency received comments and suggestions for modifications to the Proposed Rules, and, as a result, the Agency made some changes to the Proposed Rules. The Proposed Rules were published in the Florida Administrative Weekly on March 11, 2005, and a public hearing was held on the Proposed Rules on April 4, 2005. The Proposed Rules provide: 59B-15.001 Purpose The rules in this section describe the requirements for reporting Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) for the purpose of providing comparative information to consumers. 59B-15.002 Definitions "Hospital" means an entity that is licensed per Section 395.002(13), Florida Statutes. "Reporting period" means a calendar quarter. "Eligible patient" means a selected surgical patient 18 years of age or older with no prior evidence of infection as specified by the Center for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital. 59B-15.003 Exclusions State-operated hospitals. Psychiatric hospitals with no licensed acute care beds other than licensed psychiatric or substance abuse beds. Specialty rehabilitation as defined in subparagraph 59A-3.52(1)(c)2. F.A.C. Intensive Residential Treatment Programs for Children and Adolescents as defined in paragraph 59A-3.252(1)(d), F.A.C. 59B-15.004 Reporting Requirements Hospitals shall report Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) quarterly due on or before December 1, 2005 for the period April 1, through June 30, 2005. Thereafter, data shall be reported for each calendar quarter due 150 days following the end of the quarter. Hospitals shall report the following measures for all eligible patients regardless of type of payer. Prophylactic antibiotics received within 1 hour prior to surgical incision; Prophylactic antibiotic selection for surgical patients; Prophylactic antibiotics discontinued within 24 hours after surgery end time. The methodology used to prepare the measures shall meet the standards specified by the Centers for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital. CMS standards include submission of SIP data to the Quality Improvement Organization Clinical Warehouse, providing records required for reabstraction activities, and compliance with other data quality standards as specified by CMS. Hospitals shall use the SIP methodology specified by the CMS for the applicable reporting period to determine the SIP measures reported to the Agency. If the hospital uses sampling, the hospital must follow the sampling protocol specified by CMS. Hospitals shall report the population size, rate numerator value, and denominator value as specified by CMS for each type of surgery to include coronary artery bypass surgery (CABG), cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, vascular surgery, and for all of the above surgeries overall. Hospitals shall report data separately for each location consistent with Rule 59E-7.012, F.A.C. unless reporting separately would be contrary to CMS specifications. If a combined report is submitted, report the name of the hospital and AHCA hospital identification number required in subsection 59B-15.005(1), F.A.C. for each of the hospitals included in the report. The data shall be submitted in a text file, using a tab between each data element. Start a new line for each type of surgery and for each measure. Order the rows of data by type of surgery as listed in subsection (5) with three consecutive rows of data for each measure in subsection (2) above reported for each type of surgery. Each line of data shall state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of measure as in (2) above. The rate shall be reported as a decimal number greater than or equal to zero (0) and less than or equal to one hundred (100) using the format X.XX, XX.XX, or XXX.XX as required. Report hospital contact information required in Rule 59B-15.005, F.A.C. in the order specified starting a new line beginning with contact name and contact telephone number. Hospital contact information should be reported at the beginning of the document. (8) Hospitals shall send the SIP measures by electronic mail to SIPReport@ahca.myflorida.com or, if requested in writing by the hospital and approved by the Agency to the Agency's mailing address using a 3.5" diskette or CD- ROM. The mailing address of the Agency is: Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #16, Tallahassee, Florida 32308 with the statement, "Attention: State Center for Health Statistics." If the hospital has a vendor send the SIP measures to the Agency, the hospital will direct the vendor to copy (cc) the hospital contact when the report is e- mailed to the Agency. 59B-15.005 Hospital Contact Information. Each hospital shall include the following contact information when submitting a report required in this section to the Agency for Health Care Administration: Name of hospital; AHCA hospital identification number; Reporting year in four digits; Reporting quarter as a 1, 2, 3, or 4 where 1 corresponds to the first quarter of a calendar year; Contact name; Contact title; Contact address; Contact direct telephone number; Hospital telephone number; Contact e-mail address; Contact FAX number. The hospital contact information shall be reported in a text file as described in Rule 59B-15.004, F.A.C., using a tab between each data element. 59B-15.006 Certification Each hospital shall provide certification of the accuracy of the Surgical Infection Prevention Measures including all data required in this section as provided in Section 408.061(1)(a), Florida Statutes. The certification shall be submitted to the Agency for Health Care Administration (Agency) using the Certification of Surgical Infection Prevention Measures from SIP-1, dated 2/01/2005, incorporated by reference. The certification shall be submitted to the Agency for Health Care Administration (Agency) quarterly prior to or concurrent with the submission of the Surgical Infection Prevention Measures as provided in Rule 59B-15.004, F.A.C. The Certification of Surgical Infections Prevention Measures Form will be available from the Agency website at www.ahca.myflorida.com. The signed Certification of Surgical Infections Prevention Measures may be submitted electronically to SIPReport@ahca.myflorida.com. using a pdf file with a scanned signature or mailed to the Agency address provided in Rule 59B- 15.004, F.A.C. If a combined report is submitted per subsection 59B-15.004(6), F.A.C., a separate Certification of Surgical Infection Prevention Measures Form SIP-1 must be submitted for each hospital included in the report. 59B-15.007 Administrative Penalties Failure to report as required in this section in whole or in part is subject to administrative fines as provided in Section 408.08(2) and 408.08(5), Florida Statutes, unless the hospital has been granted an extension of up to 30 days by the Agency for Health Care Administration for reasons of extraordinary or hardship circumstances such as a natural disaster or emergency event impacting the hospital. Hospitals must request the extension, in writing, prior to the due date specified in Rule 59B-15.004, F.A.C. The Proposed Rules provide that the specific authority for the promulgation of the Proposed Rules is Subsection 408.06(1)(a)2., Florida Statutes, and the law implemented by the Proposed Rules is Subsection 408.05(3)(l)1., Florida Statutes. Dr. McKalip is a neurological surgeon practicing in St. Petersburg, Florida. He has hospital privileges at Bayfront Medical Center (Bayfront) and St. Anthony's Health Care (St. Anthony's). Both hospitals would be required by the Proposed Rules to report SIP Measures to the Agency. SIP Measures would be required to be reported only on the following surgical categories: coronary artery bypass surgery, cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, and vascular surgery. Dr. McKalip performs vascular surgery of the brain, vascular bypass surgery in the neck, and, as part of his board certification, is required to be able to perform carotid artery surgery in the neck. These procedures would be included under the category of vascular surgery in the ICD-9 codes as other (peripheral) vascular shunt or bypass VASC SHUNT and BYPASS NEC.2 The Proposed Rules do not require Dr. McKalip to report the use of SIP measures; they require the hospitals in which he performs the procedures to report the SIP measures. The Proposed Rules do not require the hospitals to implement SIP measures, merely to report whether the SIP measures were implemented. Some hospitals, including Bayfront and St. Anthony's, have developed policies which require physicians practicing in those hospitals to implement the SIP measures. Data collection relating to SIP measures is not a new concept. The Centers for Medicare and Medicaid Services (CMS) have developed a methodology to collect data on SIP measures, and some hospitals are currently voluntarily reporting the use of SIP measures for certain surgical procedures. The Proposed Rules adopt the methodology developed by CMS. The Proposed Rules are supported by the Florida Hospital Association; Florida Medical Quality Assurance, Inc.; and CMS. The use of SIP measures is supported by many medical societies and organizations. The Agency views the collection of the SIP measures as the first step in a three-step process for collecting and reporting hospital-acquired infection data. The second step will involve the collection of infection rates that are acquired in the inpatient setting, and the third step will involve reporting the infection rates by physicians.
Findings Of Fact At all times material hereto, Respondent has been a licensed practical nurse in the State of Florida, having been issued license number PN 0867041. At all times material hereto, Respondent was employed by American Nursing Service, Fort Lauderdale, Florida, and was assigned to work at Broward General Medical Center, Fort Lauderdale, Florida. On July 30-31, 1989, Respondent worked both the 3:00 p.m. to 11:00 p.m. and the 11:00 p.m. to 7:00 a.m. shifts at Broward General Medical Center. She was responsible for 20 patients on that double shift. An hour or two before her double shift ended, she checked the I.V. of a patient near the end of the hall. The I.V. was not running, and Respondent attempted to get it running again by re-positioning the I.V. several times. She then went to the medication room and obtained a syringe to use to flush the I.V. to get it operating again. When she returned to the patient's room, the I.V. was running and Respondent tucked the syringe inside her bra. The syringe was still packaged and unopened. She then continued with her nursing duties. At 7:00 a.m. on July 31, while Respondent was "giving report" to the oncoming nursing shift and making her entries on the charts of the patients for whom she had cared during the double shift she was just concluding, one of the other nurses noticed the syringe underneath Respondent's clothing. That other nurse immediately reported the syringe to her own head nurse who immediately reported the syringe to the staffing coordinator. The head nurse and the staffing coordinator went to where Respondent was still completing the nurse's notes on the charts of the patients and took her into an office where they confronted her regarding the syringe. They implied that she had a drug problem and offered their assistance. Respondent denied having a drug problem and offered to be tested. They refused her offer to test her for the presence of drugs. Instead, they sent her off the hospital premises although she had not yet completed making her entries on the patient's charts. Hospital personnel then went through Respondent's patients' charts and found some "errors." A month later an investigator for the Department of Professional Regulation requested that Respondent submit to a drug test on one day's notice. She complied with that request. She asked the investigator to go with her to Broward General Medical Center so that she could complete the charts on the patients that she had not been permitted to complete before being sent away from the hospital. Her request was denied. At some subsequent time, the Department of Professional Regulation requested that Respondent submit to a psychological evaluation. She did so at her own expense and provided the Department with the results of that evaluation. Respondent has had no prior or subsequent administrative complaints filed against her.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that a Final Order be entered finding Respondent not guilty and dismissing the Second Amended Administrative Complaint with prejudice. RECOMMENDED this 18th day of November, 1991, at Tallahassee, Florida. LINDA M. RIGOT 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 18th day of November, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-1775 Respondent's proposed findings of fact numbered 1-3, 6, and 8 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 4 and 7 have been rejected as not constituting findings of fact but rather as constituting conclusions of law or argument of counsel. Respondent's proposed finding of fact numbered 5 has been rejected as being subordinate. COPIES FURNISHED: Jack McRay, General Counsel Department of CProfessional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Judie Ritter, Executive Director Department of Professional Regulation/Board of Nursing Daniel Building, Room 50 111 East Coastline Drive Jacksonville, Florida 32202 Roberta Fenner, Staff Attorney Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Christopher Knox, Esquire 4801 S. University Drive, #302 W. Box 291207 Davie, Florida 33329-1207
Findings Of Fact At all times material hereto, Respondent has been licensed as an osteopathic physician in the State of Florida, having been issued license number OS-0001053 in 1954. According to Respondent's office records for a patient named Barry Belikoff, Respondent saw Belikoff in his office on twenty-five (25) occasions between September 5, 1980, and July 24, 1981, and during this time wrote twenty-four (24) prescriptions for a total of 344 Quaaludes (Methaqualone) with a dosage of 300 mg. each. According to his patient records, Respondent also saw Belikoff on thirteen (13) occasions between October 31, 1981 and June 18, 1982 and wrote four (4) prescriptions for controlled substances, including Talwin, Restoril, and Percodan. Respondent was treating Belikoff for back pains and insomnia. According to expert testimony, the records kept by Respondent of this patient's office visits were inadequate and do not provide the required documentation which would support and explain the controlled substances prescribed in this case. In addition, a proper course of patient care would not include the on-going prescription of Quaaludes over almost a one year period at a rate of over one a day without a record of additional tests, x-rays, or neurological exams during this period. Belikoff's patient records do not show any such additional tests, x- rays or exams. Without such documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Belikoff were without medical justification, excessive and inappropriate, according to expert testimony. Respondent was treating a patient named Lyndon Ellis during 1981 and 1982. Ellis was hospitalized on four occasions while under Respondent's care, and according to expert testimony the level of care and medical records for this patient, while hospitalized, were excellent. As a result of office visits by Ellis, Respondent wrote thirty-eight (38) prescriptions for controlled substances between April 20, 1981 and September 29, 1982 which included Percocet 5, Demerol, and Fiorinal. Ellis was being treated by Respondent for chronic headaches and pain from accident injuries, and also for a problem with his toe. However, according to expert testimony, the records kept by Respondent on Ellis' office visits were inadequate and do not provide documentation which would support and explain the controlled substances prescribed in this case. The absence of a thorough patient medical history, exam, evaluation, x- rays and lab tests in this patient's office records is explained by Respondent by the fact that this information was available in hospital records for this patient. Nevertheless, Respondent's office records for Ellis are totally inadequate. These office records do reflect that Respondent was aware of Ellis' overuse of controlled substances and the need to detoxify this patient on October 29, 1982. Yet he prescribed Percocet, a controlled substance, on five additional occasions after October 29, 1982. Without adequate documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Ellis were without medical justification, excessive and inappropriate, according to expert testimony. Between July 14, 1980 and April 23, 1982, Respondent treated a patient named Alan Fogler. During this time Respondent wrote twelve (12) prescriptions for a total of 464 Percodan, a controlled substance. Respondent was treating Fogler for headaches, whiplash and a concussion reported by the patient, as well as allergies, but patient records reveal no x- rays, brain scans, lab work or neurological exams. According to expert testimony, patient records in this case are inadequate and do not justify the treatment rendered which consisted primarily of prescriptions for Percodan. Without adequate patient medical records, the prescriptions for controlled substances were without- medical justification, excessive and inappropriate, accordingly to expert testimony. While treating patients Belikoff, Ellis and Fogler, Respondent repeatedly reissued prescriptions for controlled substances without a substantiation of medical reasons in the patients' office medical records. According to expert testimony concerning the standards expected of osteopathic physicians in keeping office medical records on patients, Respondent did not perform with reasonable skill, nor meet the standards expected of physicians in this aspect of their practice. Vicki Cutcliffe, a deputy sheriff with the Broward County Sheriff's Office, saw Respondent in his office on March 30, April 11 and April 25, 1984 using the alias "Vicki Tarra". After taking a brief medical history which revealed that "Tarra" used alcohol daily, Respondent began treating her for situational anxiety by prescribing controlled substances, including Librium and Tranxene. On April 25 "Tarra" told Respondent she wanted some extra pills for her friend named Jo Ann and asked him to write her friend a prescription. Respondent said he could not do that, but did give "Tarra" a prescription for Tranxene and two refills, after initially giving her a prescription which allowed for only one refill. He told her that she could give some of the pills to her friend and then she could refill the prescription twice. Respondent knew that "Tarra" wanted the extra pills for a friend and that she would give them to her friend who was not a patient of Respondent. According to expert testimony, the treatment given to "Tarra" by Respondent, which consisted simply of prescriptions for controlled substances without adequate documentation of the reasons for this course of treatment in the patient's medical records, was totally inappropriate. Increasing a prescription when a patient says they want some extra pills for a friend is never justified and constitutes malpractice, according to expert testimony.
Recommendation Based upon the foregoing it is recommended that a Final Order be issued suspending Respondent's license for a period of two ( 2) years. DONE and ENTERED this 30th day of September, 1985, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 3 2301 (904) 488- 9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 1985. COPIES FURNISHED: Stephanie A. Daniel, Esq. Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 John W. Gaul, D.O. 11360 Tara Drive Plantation, FL 33325 Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners 130 North Monroe Street Tallahassee, FL 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 ================================================================ =
The Issue The issue to be determined in this proceeding is whether Respondent, Babak Saadatmand, M.D. (Respondent or Dr. Saadatmand), has violated section 458.331(1)(m) and (t), Florida Statutes (2013), as alleged in the Administrative Complaint.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and the entire record of this proceeding, the following findings of fact are made: The Parties Petitioner, the Department of Health, is the agency charged with the regulation of the practice of medicine pursuant to chapters 20, 456, and 458, Florida Statutes. Respondent, Babak Saadatmand, M.D., is a medical doctor licensed by the Board of Medicine. Dr. Saadatmand holds Florida license number ME 114656. Respondent graduated from the University of Maryland, College of Medicine, in 1988, and completed his residency at Case Western Reserve. He then completed a residency in emergency medicine at Cook County Hospital in Chicago, Illinois. Respondent was board-certified in internal medicine, but no longer holds that certification because at the time it was due for renewal, he was no longer eligible because his practice was devoted to emergency medicine as opposed to internal medicine. He remains board-certified in emergency medicine. Respondent has held positions that required him to supervise residents and give lectures at Yale University, New York College of Medicine, and Indiana University. Dr. Saadatmand chose to practice emergency medicine as a traveling physician for the last three years, because of the financial benefits available by doing so while he gained additional experience in emergency medicine. However, he has since or now accepted a position as the assistant program director of the emergency medicine residency program at Jackson Memorial Hospital in Miami, Florida, where his job responsibilities will include the supervision of residents. Dr. Saadatmand holds a medical license in several other states in addition to Florida, and has not been disciplined in any state where he is licensed. Dr. Saadatmand’s Treatment of R.D. In June and July of 2014, Respondent was working as a traveling physician at Parrish Medical Center in Titusville, Florida. While most of his assignments in various emergency facilities have been six months long, the assignment at Parrish Medical Center was for approximately one month. Respondent treated patient R.D. on June 27, 2014, at Parrish Medical Center emergency room. R.D. was accompanied by his wife, C.D. R.D. was a 52-year-old male when he presented to Parrish Medical Center. He had a history of T-cell lymphoma and had been treated for his cancer through the Space Coast Cancer Center. Just days before his presentation to the emergency room on June 27, 2014, he had been cleared to return to his place of employment. However, on June 27, 2014, R.D.’s supervisor called R.D.’s wife, C.D., and asked her to come get R.D. as he was too ill to be at work. R.D. arrived at Parrish Medical Center in the early afternoon, and was triaged by a nurse at approximately 2:13 p.m. The notes from the triage nurse’s assessment recorded, among other things, R.D.’s vital signs upon arrival; his chief complaint, including its duration and intensity; a brief medical history; a list of his current medications; and a drug/alcohol use history. Registered Nurse Sharon Craddock was the emergency room nurse who completed the initial assessment, or triage assessment, of R.D.’s condition. According to her triage notes in the Parrish Medical Center records, R.D.’s chief complaint upon arrival was constipation, which was described as constipation for three days, with bilateral abdominal pain. The pain was described as aching, pressure, shooting, and throbbing, and R.D.’s pain level was reported in Ms. Craddock’s notes as being an eight on a ten-point scale. Her description of his abdomen was “soft, non-tender, round, and obese.” Nurses are directed to record the pain level reported by the patient, and not to alter the pain level based on the nurse’s observation.1/ R.D.’s vital signs were taken upon his arrival at Parrish Medical Center and were recorded in the electronic medical records as follows: temperature, 98.4F; pulse, 127H; respiration, 20; blood pressure, 120/70; and pulse oximeter, 95. The only abnormal reading reflected in R.D.’s vital signs was his pulse, which was above 100, considered to be the upper limit of normal. R.D. reported that he had a medical history which included T-cell lymphoma and that he did not smoke or drink. His current medications were listed as aspirin, Zyrtec, Amaryl, Metformin, Prilosec, Percocet, Pravastatin, and a multivitamin. The Percocet dosage was listed as one tablet, three times daily, as needed for pain. Ms. Craddock also recorded a nursing note for R.D. at 3:37 p.m., and she was in the room when Respondent first went in to see R.D. Ms. Craddock’s nursing note indicates, “Pt with a hx of stomach CA with a recent ‘clean bill of health’ presents with ABD pain and constipation. Occasionally takes Percocet for pain. Wife at BS. Pt. sleepy, states he normally takes a nap this time of day. Pending MD eval with orders.” The Parrish Medical Center chart documents that R.D. was calm, cooperative, and asleep at 15:37 hours (3:37 p.m.). This presentation is generally inconsistent with a patient who is in severe abdominal pain. Dr. Saadatmand saw R.D. at approximately 3:56 p.m. Consistent with the custom at Parrish Medical Center, he worked with a scribe who took Respondent’s dictation for notes during his visit with the patient, and then loaded those notes into the electronic medical record. Respondent would then have the opportunity to review the notes as transcribed and direct the scribe to make any necessary changes. Dr. Saadatmand’s notes indicate that R.D. presented with abdominal pain, and was experiencing moderate pain that was constant with cramping. The description of R.D.’s pain as moderate was based upon Dr. Saadatmand’s observation of R.D. The chief complaint listed was constipation. Dr. Saadatmand took a history from R.D., who reported that he had been diagnosed with gastric lymphoma in 2013, and was treated with radiation and chemotherapy. R.D. and his wife, C.D., reported to Respondent that they feared his cancer might be returning, as his current symptoms were similar to those he experienced when his cancer was first diagnosed. He had returned to Space Coast Cancer Center for some additional screening two to three weeks before the emergency room visit, which included a CT of the abdomen and an upper and lower endoscopy. R.D. and his wife both believed that the results of the screening were normal. Respondent recorded this conversation in the electronic medical record as “[R.D.] had a recent follow up with Dr. Rylander and had normal EGD and colonoscopy. [R.D.] had recent CT scan with cancer center.” Space Coast Cancer Center does not use Parrish Medical Center to perform its CT scans or other testing, so the results of the recent CT scan were not available for Respondent to view. Respondent believed that R.D. and C.D. had followed the directions of R.D.’s oncologists, and R.D. had been a compliant patient. Respondent asked R.D. about his use of Percocet. He did not ask how much he was taking, but how often and whether the use had changed. He considered the answer to this question to be important, because a change in the use could indicate a change in R.D.’s pain intensity. R.D. did not report any change in the amount that he was taking, which was generally an “every other day thing for him.” Respondent testified that, given that the type of Percocet that R.D. was prescribed was an extra-strength as opposed to a standard version of Percocet, it was highly likely that R.D. would suffer from opioid-induced constipation. R.D. reported to Respondent that he had not attempted any laxatives. R.D. also denied having any nausea or surgical history. The lack of a surgical history is significant because patients with a recent surgical history and abdominal pain may be experiencing complications related to the surgery, which would account for the patient’s pain. There is no reference to R.D.’s diabetes in either the nursing triage notes or Dr. Saadatmand’s notes. The only reference in the past medical history is the report of cancer. The list of medications R.D. was taking at home includes Metformin HCI. No evidence was presented to establish whether Metformin is a drug prescribed only for diabetes or whether it is an accepted treatment for other conditions. Moreover, there is no evidence presented to establish how Respondent was to know that R.D. was diabetic if R.D. did not report the condition. In addition to taking R.D.’s medical history, Respondent performed a review of systems and a physical examination, including palpation of his abdomen. In his chart, the electronic medical record states under “review of systems,” “All systems: Reviewed and negative except as stated.” Under the category “Gastrointestinal,” the record indicates “Reports: Abdominal pain, Constipation. Denies: Nausea, vomiting, Diarrhea.” In the physical examination section of the electronic medical record, it is noted that R.D. was alert and in mild distress. The cardiovascular examination indicates that R.D. had a regular rate, normal rhythm, and normal heart sounds, with no systolic or diastolic murmur. With respect to his abdominal exam, Respondent indicated, “Present: Soft, normal bowel sounds. Absent: Guarding, Rebound, Rigid.” The notation that the abdomen was soft with normal bowel sounds is another way of noting that the abdomen is non-tender. Because R.D. was tachycardic upon presentation to the emergency room, Dr. Saadatmand noted R.D.’s anxiety about the possibility of his cancer returning, and checked his pulse a second time. When Respondent checked R.D.’s pulse, it had slowed to 90, which is within a normal range. In light of R.D.’s normal vital signs, normal abdominal examination, and the length of his pain and constipation, Respondent determined that the most likely cause for Respondent’s pain was constipation, and communicated that determination to R.D. and C.D. He asked whether R.D. had used a laxative and was told he had not. Dr. Saadatmand told R.D. and his wife that the pain medication that he took could be a source for his constipation, and that it would be prudent to try a laxative and see if that produced results before considering any further diagnostic tests. Respondent did not order any lab tests for patient R.D. on June 27, 2014, because his vital signs and abdominal examination were normal. He did not order an EKG for R.D. because there were no symptoms to indicate a cardiac issue. Respondent also did not order a CT scan of the abdomen or pelvis for patient R.D. on June 27, 2014. He felt that, in terms of R.D.’s concern about cancer recurrence, there were tests available to R.D.’s oncologist that would be more useful in detecting any recurrence of R.D.’s cancer that are not available through an emergency room visit. For example, a PET scan would be the most helpful, but is not something that Respondent could order through the emergency room because it is not considered an emergent study. The Department has not alleged, and the evidence did not demonstrate, that R.D. suffered from any emergency condition that additional testing would have revealed and that went undetected by Dr. Saadatmand. Respondent did order a prescription-strength laxative, i.e., Golytely, for R.D., which is a laxative commonly used to treat constipation and to prepare patients for a colonoscopy. Dr. Saadatmand communicated his recommendation to R.D. and C.D., who seemed relieved that the problem might be limited to constipation. He also advised them to return to the emergency room should R.D.’s symptoms get worse or if he developed a fever, because those developments would indicate a change in his condition. R.D. received discharge instructions that are consistent with Dr. Saadatmand’s discussion with R.D. and his wife. The discharge instructions referred R.D. to his primary care physician, noted the prescription for Golytely, and provided information related to the community health navigator. The Patient Visit Information sheet received by R.D. specifically noted that the patient was acknowledging receipt of the instructions provided, and stated, “I understand that I have had EMERGENCY TREATMENT ONLY and that I may be released before all my medical problems are known and treated. Emergency medical care is not intended to be a substitute for complete medical care. My Emergency Department diagnosis is preliminary and may change after complete medical care is received. I will arrange for follow-up care.” R.D. also received printed materials about constipation and how to address the problem. These instructions stated that the patient should contact his or her primary care provider if the constipation gets worse, the patient starts to vomit, or has questions or concerns about his or her condition or care. It also instructed the patient to return to the emergency room if he or she had blood in his or her bowel movements or had a fever and abdominal pain with the constipation. R.D. signed the acknowledgment that he had read and understood the instructions given to him by his caregivers. The acknowledgment specifically referenced the instructions regarding constipation. The written instructions are consistent with the verbal advice provided by Respondent. R.D.’s Subsequent Treatment Unfortunately, R.D.’s symptoms did not improve. He developed a fever and his pain level increased significantly. As stated by his wife, his pain the following day was “way worse” than when he saw Dr. Saadatmand. After a call to her niece, a nurse that worked in the emergency room at Parrish Medical Center, C.D. took R.D. back to the hospital on June 28, 2014, at approximately 6:30 p.m. At that point, he had a heart rate of 125, a temperature of 101.6 degrees, and tenderness in the lower left quadrant of his abdomen. Testing indicated that R.D. had intra-abdominal masses and small collections of extra-luminal gas that suggested the possibility of a contained micro-perforation. There is no allegation in the Administrative Complaint that the micro- perforation existed at the time R.D. saw Respondent. R.D. died on August 23, 2014, as a result of end-stage T-cell lymphoma. The Expert Witnesses The Department presented the expert testimony of Annie Akkara, M.D. Dr. Akkara is board-certified in emergency medicine and has been licensed to practice medicine in Florida for approximately nine years. All of her practice has been in the greater Orlando area in the Florida hospital system. She worked full-time for one year when she first moved to Florida, and since that time approximately 80 percent of her practice has involved reviewing medical charts for Veracode Associates, to determine whether diagnostic codes are fully supported in the medical records. She takes emergency room shifts on an as-needed basis, and has supervisory responsibility over patient extenders, such as nurses and physicians’ assistants, but not over other physicians. Dr. Akkara has never served on any committee for a medical staff at a hospital or helped develop protocols for an emergency room, and has not conducted any type of medical research. Although her position requires her to review electronic medical records, she was not familiar with the program used by Parrish Medical Center. Dr. Akkara reviewed the medical records for the emergency room visits for both June 27 and 28, 2014, as well as the records from the inpatient admission after the June 28 visit. She also reviewed the expert witness reports of Drs. Orban and Smoak. Dr. Saadatmand presented the expert testimony of David Orban, M.D. Dr. Orban practices emergency medicine in the Tampa area. He attended medical school at St. Louis University and completed residencies in orthopedics and emergency medicine. Dr. Orban has been licensed to practice medicine in Florida since 1982 and has been board-certified in emergency medicine since 1981. Before he practiced in Florida, Dr. Orban served as an instructor in surgery at the Washington University School of Medicine, and from 1970 through 1983, was an assistant professor of medicine at the University of California, Los Angeles (UCLA). In that position, he supervised residents in the emergency medicine program and helped to develop the program’s curriculum. Dr. Orban left UCLA in 1983 and moved to Florida, in order to help establish the emergency medicine residency program at the University of Florida. Currently, Dr. Orban is the director of emergency medicine for the University of South Florida (USF), College of Medicine, and the Medical Director Emeritus for the Tampa General Hospital Emergency Room. The USF emergency medicine residency program is a competitive program which receives approximately 1,200 applications each year for ten residency positions. Dr. Orban continues to spend approximately 20-24 hours each week practicing in the emergency room, in addition to his teaching responsibilities. He both sees patients on his own and supervises residents who are seeing patients. He has extensive experience in evaluating non-traumatic abdominal pain in the emergency room.2/ Allegations Related to the Standard of Care Dr. Akkara testified that in her opinion, Dr. Saadatmand’s care and treatment departed from the standard of care in a variety of ways. She agreed that Respondent assessed R.D.’s abdomen, but believed that he erred in not specifically documenting that the abdomen was not tender. In this case, the patient record specifically states, “Abdominal exam: Present: Soft, Normal bowel sounds. Absent: Guarding, Rebound, Rigid.” In Dr. Akkara’s view, the notes should have been more specific, and she found fault with the fact that the notes did not use the words “tender” or “non-tender.” Dr. Orban, on the other hand, noted that Respondent specifically documented the absence of guarding, rigidity and rebound tenderness, and described the abdomen as “soft, with normal bowel sounds.” Dr. Orban testified that assessing an abdomen for guarding, rigidity, and rebound are all forms of checking for abdominal tenderness. He did not hesitate to interpret Respondent’s medical records for R.D. as reflecting a normal exam, meaning no tenderness was discovered. Dr. Orban’s opinion is supported by the differences in the medical records from R.D.’s June 27 and 28 emergency room visits, and what options are provided in the electronic medical record when a positive finding for tenderness is chosen. Dr. Orban’s testimony is credited. The Administrative Complaint alleges and Dr. Akkara opined that Respondent departed from the appropriate standard of care by failing to obtain a complete set of normal vital signs before R.D. was discharged from the hospital. The only vital sign that was ever abnormal during R.D.’s June 27 visit was his heart rate, which upon arrival was 127. Respondent rechecked R.D.’s heart rate when he examined him, and upon re-examination it was 90, well within normal limits. Dr. Orban did not believe that the standard of care required the physician, as opposed to possibly supportive staff, to obtain a complete set of vital signs prior to ordering a patient’s discharge. The evidence established that while there is sometimes a nursing standard in emergency rooms requiring a nurse to obtain a second set of vital signs before a patient is discharged, there is no corresponding standard that requires the physician to repeat all of the vitals as well. Dr. Akkara admitted that while she attempts to get a complete set of vital signs before she discharges a patient, she does not always succeed in doing so. The evidence did not demonstrate a departure from the standard of care for not obtaining a second set of vital signs prior to discharge, especially where, as here, all of R.D.’s vital signs were normal when he arrived at the emergency room, except for his heart rate, and Dr. Saadatmand did, in fact, re-assess R.D.’s heart rate prior to discharge. The Administrative Complaint alleges that Respondent fell below the standard of care by not ordering routine lab work for R.D. The Administrative Complaint does not allege what purpose the routine lab work would serve in the emergency treatment of R.D. Dr. Akkara testified that routine lab work should have been completed before discharge, and that it was a departure from the standard of care not to do so. She stated that the labs were necessary to assess white blood cell count, glucose levels, and kidney function, and in those cases where tenderness was noted in the upper right quadrant of the abdomen, also could indicate issues with the patient’s liver enzymes. Dr. Akkara acknowledged, however, that it is possible for a CBC (complete blood count) to be frequently misleading in patients with abdominal pain, and is often normal with patients with appendicitis. Blood work often cannot distinguish between serious and benign abdominal conditions, and Dr. Akkara admitted that with respect to R.D., given the records from the subsequent admission, any results from a CBC ordered on June 27 would not have altered the treatment of the patient or changed his ultimate outcome. Dr. Orban testified that in the majority of cases where a CBC is ordered in the emergency room, it is not helpful. Ordering a CBC is helpful where a patient has a fever because it would help identify infection, or where a patient appears anemic. Other than those instances, it is not all that useful and is over-utilized. A chemistry panel measures a patient’s serum levels for things like sodium, creatinine, and glucose. Dr. Orban testified that, even with a diabetic patient, unless the patient is experiencing vomiting, mental status changes, blurred vision, frequent urination, or other symptoms associated with diabetes, a blood chemistry panel would not be helpful for assessing a patient with non-traumatic abdominal pain. Records for R.D.’s June 28 visit (the day after Respondent saw R.D.) note that he was diabetic, while the June 27 records do not. However, it was not established that either R.D. or his wife ever told anyone, whether nursing staff or Dr. Saadatmand, that he was diabetic. There is no testimony that his prescription for Metformin was to treat diabetes, as opposed to some other condition, and there was no evidence to indicate that diabetes is the only condition for which Metformin can be prescribed. Dr. Akkara repeatedly referred to R.D.’s diabetes as a basis for her opinions, but never identified the records that formed a basis for her knowledge of R.D.’s diabetic condition. The evidence presented does not establish that ordering a blood chemistry or CBC was required by the appropriate standard of care related to the care and treatment of R.D. in the emergency room on June 27, 2016. Dr. Akkara also testified that Respondent departed from the standard of care by failing to obtain a CT scan of the abdomen and pelvis. Her opinion is based, at least in part, on her belief that Respondent failed to document that R.D.’s abdomen was non-tender. She agreed with Dr. Orban that if a patient has no abdominal tenderness, then a CT scan is probably not warranted. In addition, Dr. Orban testified credibly that over the last ten years, there has been a trend toward over-utilization of CT scans, with the concomitant increased risk of radiation- induced cancer. In this case, R.D. had reported having a CT scan just weeks before this emergency room visit. His abdomen was not tender. In a case such as this one, where the patient presents with non-traumatic abdominal pain and a normal abdominal examination and no fever, a CT scan is not warranted. Dr. Orban’s testimony is credited. There is not clear and convincing evidence to establish that the standard of care required Respondent to order a CT scan under the circumstances presented in this case. Dr. Akkara testified that Respondent also violated the standard of care by not ordering an EKG for R.D. However, she acknowledged that R.D. did not present with any cardiac-related symptoms and denied chest pain. The purpose of an EKG is to explore any cardiac-related symptoms, and R.D. did not present with any. Dr. Akkara did not provide any protocols that dictate when an EKG should be ordered. Dr. Akkara also acknowledged that ordering an EKG would have no impact on the care provided to R.D., and that a patient does not need an EKG just because he or she walks in the emergency room with tachycardia.3/ The Department did not establish that the failure to order an EKG violated the applicable standard of care in this case. The Department also has charged Respondent with failing to arrange for follow-up care and failing to discuss follow-up care, as well as reasons for R.D. to return to the emergency room, if necessary. However, as noted in paragraphs 32-34, Dr. Saadatmand discussed follow-up care with R.D. and told him what circumstances would require a return visit to the emergency room. Dr. Akkara acknowledged that the discharge instructions given to R.D. were adequate. As stated by Dr. Orban, the role of an emergency room physician with regard to the assessment of patients is to identify emergency situations and treat them. Emergency situations are those that are acute, rapidly decompensating, and that require either medical or surgical intervention, with most likely a hospital admission for more definitive care. It is not the emergency physician’s responsibility to manage a patient’s chronic conditions. It is routine to advise patients with non- acute conditions to follow up with their established physicians and to provide written instructions to that effect. Dr. Saadatmand’s actions in providing instructions, both in terms of follow-up and possible return to the emergency room, were consistent with the standard of care. Finally, the Administrative Complaint finds fault with Dr. Saadatmand for not conducting another abdominal examination and not re-assessing R.D.’s vital signs prior to discharge. As noted previously, the only vital sign that was abnormal when R.D. arrived was his heart rate. Respondent did re-assess R.D.’s heart rate prior to discharge, and it was normal. With respect to a second examination of Respondent’s abdomen, the Department did not establish that one was necessary. Here, Respondent’s initial examination was normal, and there was a reasonable explanation for his discomfort that Respondent believed needed to be addressed before going any further. Dr. Akkara offered no protocol or other authority other than her own clinical experience to support the opinion that serial examinations of the abdomen were required. On the other hand, Dr. Orban testified that where, as here, where the first examination was normal and there was no fever or vomiting, no second examination would be required.4/ Dr. Orban’s testimony is credited. In summary, the Department did not establish that Respondent violated the applicable standard of care in his care and treatment of R.D. Further, his medical records, while not perfect, justify the course of treatment provided in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 5th day of December, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 5th day of December, 2016.
