The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(m) and (t), Florida Statutes (2005)?
Findings Of Fact Stipulated Facts: Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is John B. Milton, M.D. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 53961. Respondent's mailing address of record is 4702 Van Kleeck Drive, New Smyrna Beach, Florida 32169. Additional Facts: Hospital Records (Petitioner's Exhibit numbered 1) On December 31, 2005, Patient W.C. came to the Bert Fish Medical Center (Bert Fish) in New Smyrna Beach, Florida, at 1:40 a.m. He was 40 years old at the time. He was seen in the Emergency Department at Bert Fish. Triage of the patient took place at 1:43 a.m. The triage record reports that he walked in to the hospital complaining of his throat swelling and difficulty breathing. The record reflects that the patient was experiencing pain of an intensity level seven (7) in his throat. At the time his blood pressure was 153/83. His pulse rate was 88. His respirations were 20. His temperature was 98.2. His 02 sat. was 99. In the heading within the Emergency Department Triage Record, statement of "Previous Surgery/Other Medical Hx (referring to history)" it states "allergic reaction to birds with throat swelling, " According to the Emergency Department triage nursing notes Patient W.C. was first seen by Respondent at 1:55 a.m. on the aforementioned date. Respondent was serving in the capacity of emergency room physician at Bert Fish at the time. Among the nursing note entries in the Emergency Department triage record for Patient W.C. are handwritten nursing notes that state: At 2:05 Rocephin was given; at 2:20 a.m. pt. (patient) states throat closing saO2 98%; at 2:25 a.m. pt. (patient) tubed by Dr. Milton- placement checked tube pulled-(pt.) patient vent 100% O2 via ambu; at 2:31 a.m. crick. (cricothyroidotomy) by Dr. Milton tube inserted 100% 02; at 2:35 a.m. H/R 40's - atropine; at 2:37 a.m. b/p 213/90 P-87 Dr. Milton attempting crick 0249 epi 1 mg IV; at 2:41 a.m. Dr. Schreiber here; at 2:43 pt. (patient) tubed by Dr. Schreiber s/r 0 pulses and at 2:54 a.m. code called by Dr. Milton. The Bert Fish Emergency Physician Record refers to Patient W.C.'s chief complaint as "shortness of breath." It states "pt (patient) seems to have acute severe pharyngitis and difficulty breathing and mild stridor at rest." The degree of the condition is further described in the record as "moderate." An associated symptom is listed under "Pulmonary," as "cough." It is noted in this record that the patient is experiencing a "sore throat." The Emergency Physician Record under the "Social Hx (history)," notes that the Patient W.C. was a "smoker" and occasionally used "alcohol." No reference is made to the use of any other form of drugs. On the patient chart describing a physical exam performed on the patient, the categories of "alert" and "anxious" are checked. The level of distress is described as "NAD." There is a reference to "pharyngeal erythema," associated with that entry a handwritten note states "mild stridor at rest." A reference is made to "lymphadenopathy" both right and left "mild." There was no "respiratory distress" and "breath sounds nml (normal);" Again the condition "stridor" is noted while the patient is "at rest." "CVS" is noted as regular rate rhythm with "no JVD." On the same page as discussed in the preceding paragraph, within the patient record maintained by Bert Fish, under "clinical impression," Respondent notes several things in the overall experience in treating the patient. They are in turn: acute severe pharyngitis/epiglottitis; emergency cricothroidotomy cardio pulmonary arrest and ER death. These entries reflect events at the end of the case. The medication administration record at Bert Fish in relation to Patient W.C. notes administration of Decadron (a steroid) at 2 a.m.; Solu-cortef (a steroid) at 2:02 a.m.; Rocephin (an antibiotic) at 2:05 a.m.; Versed (a sedative) at 2:20 a.m. and Anectine (a paralytic agent) at 2:25 a.m. A separate set of entries is made in the Code Blue Record at Bert Fish, noting the administration of Epinephrine, and Atropine during the Code Blue response prior to Patient W.C.'s death due to his cyanotic condition (lack of oxygen). Nurse's notes on the Code Blue Record for Patient W.C. maintained by Bert Fish state: Upon me entering the room Dr. Milton was doing CPR on pt. Dr. Schreiber, Dr. Milton and the ER staff attending to pt. ER staff busy. I started scribing for them. Note pt. was in PRA throughout the code. Pt. was given 3 ep. & 3 atoprine total = (-)response. Respondent signed the Code Blue Record as physician. The ER Physician's Order Sheet, as signed by Respondent concerning Patient W.C., in a shorthand reference, describes orders for nebulized racemic Epinephrine, which is an aerosol adrenaline agent, together with the Solu-cortef, Decadron and Rocephin. In the records maintained by Bert Fish concerning Patient W.C., there is a handwritten note made by Respondent at 3:35 a.m., on December 31, 2005, following Patient W.C.'s death, which says: S/P IV steroids, Racemic epinephrine PT continued to c/o "getting worse" "can't breath." At times his respirations were gasping. .. I discussed with him fact the he may require intubation & he understood. PT placed in TRI and preparation made for intubation. PT had secure IV site, Respiratory TX in Room to assist. S/P preoxygenation 1HR> 80 PT had IV Versed and Anectine to facilitate intubation. The laryngoscope revealed a massive "beefy" appearance of the epiglottis. Attempted X 2 E 8.0 & 7.5 ET to secure an airway but Ø success. PT had attempts to ventilate E BVM? Ø air movement. PT cyanotic @ this point so a scalpel was used to attempt a crichothyroidotomy. When a ETT was passed thru the incision however attempts to ventilate were again unsuccessful. Dr. Schreiber (gen surgery) had been paged and he responded. He was able to place a ETT in the airway but by now PT had arrested. Monitor-bradycardia at this time ACLS measures were undertaken and PT given repeated doses of atropine/epinephrine/CPR-> ventilated E BVM. PT continued to have Ø response to proper ALS measurers and Resus efforts stopped @ 0254. Patient Care Explained Nurse Haas William Haas, R.N., was working at Bert Fish on the early morning that Patient W.C. was seen. Nurse Haas first saw the patient around 1:55 a.m. He hooked the patient up to a monitor and took his vital signs. None of the readings were considered by the nurse to be abnormal. Those readings were blood pressure 153/83, heart rate 88, respirations 20, temperature 98.2. and O2 sat. 99%. Patient W.C. was taken into treatment room 16 and was seen by Respondent and nurse Haas. Nurse Haas asked Respondent what Respondent thought was wrong with the patient. Orders were given by the Respondent for 8 mg. of Decadron and 100 mg. of Solu-cortef IV. The purpose of these medicines was to reduce inflammation. Both medications were steroids designed for that purpose. At that time Respondent gave an order for the antibiotic Rocephin. Respondent also wanted a racemic Epinephrine treatment. That treatment was to be provided by the respiratory therapist. When nurse Haas first saw the patient, the patient was complaining about difficulty breathing. Nurse Haas did not observe any manifestation of those difficulties. At one point the patient told nurse Haas that he, the patient, was experiencing an allergic reaction to feathers or birds. The patient told nurse Haas by way of history that it happened to him in the past. (None of this was true. He had no allergy to birds. The patient's deception was never discovered by the hospital treatment team, and they all proceeded on the basis that the patient had a bird allergy.) On the evening before arriving at the hospital, the patient explained to nurse Haas that he went to bed about 9:00 or 10:00 p.m. and woke up around 1:00 a.m. with a raspy feeling in his throat and he felt like his throat was closing up. So he came to the emergency room for care. After attending to the patient in treatment room 16, nurse Haas left the presence of the patient. He next saw the patient standing in treatment room 17 talking on the phone. This was around 2:20 a.m. The patient was again placed on a monitor to track his vital signs. Nothing about those vital signs appeared abnormal. At that time Mary Boothe, R.N., told nurse Haas that the patient was going to be intubated. Nurse Haas inquired of Respondent on the subject, and Respondent told nurse Haas that the patient wanted to be intubated and to get ready to perform the intubation. The procedure for intubation that was being utilized by Respondent is referred to as rapid sequence intubation or RSI. Nurse Haas retrieved Anectine and Versed to be administered in the intubation. The patient was told about the procedure for intubation. The patient was laid down. Nurse Haas gave the patient Versed and Anectine. The Versed was designed to, as nurse Haas describes it, "muddle the mind." The Anectine was an agent that would promote paralysis in the area where the intubation would occur. When in treatment room 17, at around 2:20 a.m., the patient said to nurse Haas that the patient felt that his throat was closing. Those remarks were made when the patient was being hooked up to the monitor to measure his vital signs. This was the second time that the patient had mentioned his throat closing. He had made similar remarks when nurse Haas first saw him in treatment room 16. Steve Igrec, R.T., participated in the intubation procedure in addition to nurse Haas, nurse Boothe and Respondent. Prior to the laryngoscope being introduced in the intubation procedure, nurse Haas did not notice any sharp decline in Patient W.C.'s vital signs. When Respondent accessed the airway for Patient W.C., nurse Haas heard Respondent say, "Oh, he's got epiglottitis," while proceeding further with the intubation. Respondent was unable to intubate and removed the ET tube. Another tube was used to try and intubate, again without success. Nurse Boothe Nurse Boothe first encountered Patient W.C. after he had undergone his racemic Epinephrine treatment. He came out of the treatment room and told her that he did not feel that the treatment had worked. Respondent came by and the nurse repeated what the patient had told her. Nurse Boothe did not notice anything about the patient that made her believe that he was having difficulty breathing. He coughed and told her, "Can you hear it?" but he was not gasping for air, nor making gestures about his chest or throat. Respondent then offered the patient the option of being admitted to the hospital and continuing treatments by steroids to address his condition or putting him on a ventilator and letting him have the treatments through the ventilator. The patient elected the latter option. The ventilator option would allow the patient to be released the next day. The patient was told by Respondent that he would "knock him out" and put the tube in and give the patient the medication that way and that the patient's release would come the next day. Nurse Boothe did not hear the Respondent make any mention to the effect of what might happen if there were difficulties in intubating the patient. The attempted intubation was made in the treatment room 17, which is also referred to as CC-1. The patient walked into the room. Once in the room nurse Boothe did not notice anything about the patient that indicated any difficulty breathing. The patient did mention that he was not feeling any better. Nurse Boothe overheard the patient talking on the telephone. On his end of the conversation he told his wife that he did not feel any better and that they were going to "knock him out" and put him on a breathing machine overnight and that he would see her the following day. Nurse Boothe noticed that as the attempted intubation proceeded, the patient began to have trouble with the intubation. The equipment that was in the room for those purposes included the laryngoscope, the intubation tube, and a stylet. Before the tube was introduced the patient was being ventilated with a bag and mask. When difficulties arose concerning the intubation, nurse Boothe left the treatment room to get a scalpel and to get what is referred to as a "cric" kit. That kit is a set-up that has been assembled to aid in providing emergency access to the trachea. The kit is not kept in treatment room 17. It was kept in another room on a respiratory cart. Nurse Boothe observed Respondent utilize the scalpel and the "cric." After the Respondent experienced difficulties in this effort, the on-call surgeon was contacted by a secretary at the hospital. The Surgeon Arrives On December 31, 2005, Dr. Schreiber was the on-call surgeon at Bert Fish. When he was paged by the hospital, he called and was told that he needed to go immediately to the emergency room because of an airway problem. He received the call at approximately 2:30 a.m. He arrived at the hospital at 2:41 a.m. Once at the hospital Dr. Schreiber, took over and performed surgery, insertion of the endotracheal tube, thereby ventilating the patient. That procedure by Dr. Schreiber was quickly performed. Mr. Igrec Mr. Igrec administered the racemic Epinephrine treatment to Patient W.C. Prior to providing the treatment Mr. Igrec visibly examined the patient to see if the patient was using assessory muscles to breathe or if he had any stridor, any wheezing or anything of that nature. He did not observe the patient using any assessory muscles to breathe. He did not notice the patient evidencing stridor, that is to say a high- pitched sound that is made when a person experiences upper airway obstruction. Mr. Igrec provided two of the treatments to Patient W.C. Before the second treatment, he visibly examined Patient W.C. and did not notice the patient having difficulty breathing. Sometime during the course of the treatment, near the end, the patient asked the question, "How long is this going to take to work?" Mr. Igrec told the patient to give it time. The patient appeared anxious. He did not appear short of breath. Mr. Igrec reported to Respondent that he had provided Patient W.C. the second treatment. Following the second treatment, Mr. Igrec suggested to Respondent the use of Decadron to aerosolize Patient W.C. The racemic Epinephrine is a short- acting drug, and Decadron is a steroid that takes longer to work. In response, the Respondent told Mr. Igrec "We may have to intubate." Mr. Igrec was called to treatment room 17 where Respondent told him that they were going to intubate Patient W.C. In preparation, an ambu-bag, mask, intubation tube, pressure cuff, stylet and strap were retrieved. The cuff was used to keep the intubation tube in place during the procedure. The stylet keeps the tube rigid. Once the patient was sedated, Mr. Igrec began to use the ambu-bag with the patient. At that time, there was no difficulty using the bag, squeezing the bag to provide air into the patient's lungs. Mr. Igrec had one hand on the mask over the patient's face and one hand on the ambu-bag. Respondent used the laryngoscope in placing the tube, trying to look while placing the tube. The tube went into the stomach and not the trachea, such that ventilation did not occur. After that, when Mr. Igrec was bagging the patient he had a lot more resistance, to the point where Respondent had to hold the mask while Mr. Igrec bagged the Patient W.C. After a second attempt to intubate the patient, Respondent attempted to establish a surgical airway. Respondent was using a scalpel and palpating the patient to try and find the crichothyroid cartilage to create the necessary incision. An incision was created. There was no success in placing an airway because the tube did not pass through the crichothyroid cartilage. Mr. Igrec understood this because the tube that he had cut down to place and to ventilate the patient could not be used because there was no hole in the trachea. Blood was pooling around the patient. Dr. Schreiber arrived and established the surgical airway. During this time, CPR was provided the patient under Code Blue conditions where the patient's heart had stopped beating. Attempts at reviving the patient were not successful. Respondent and Patient W.C. Prior to the occasion when he intubated Patient W.C., Respondent had vast experience in performing intubations. As he describes it, this is a necessary skill for an emergency room doctor, recognizing that having an unobstructed airway is vital to a patient's survival. When intubating a patient, Respondent believes that you would want to do this before they "crash," before they lose their vital signs and become unconscious. Before his attempt to intubate Patient W.C., Respondent had never had an instance in which he could not intubate the patient, a function that he had performed numerous times without the assistance of a surgeon or an anesthesiologist. By contrast, before the circumstance that was confronted in Patient W.C., Respondent had never performed a crichothyroidotomy. He had been trained to perform that procedure. On December 31, 2005, nurse Haas approached Respondent and told Respondent that he placed Patient W.C. in a treatment room, described as the ortho room, and that the patient was having trouble breathing and that he needed to be seen by Respondent. Respondent inquired of the patient about the duration of his problem. He asked the patient if he had asthma. Had this happened before? The patient told Respondent that he was having an allergic reaction to his wife's bird and that this problem that he was experiencing had occurred once years before. Respondent asked the patient if he was telling Respondent that an hour ago he was fine and that now he was not. Patient W.C. said "absolutely." When listening to the patient's lungs Respondent did not notice any wheezing. There was no fever in the patient and the patient had not been sick. Unlike the other health care providers attending the patient, Respondent observed that Patient W.C. was having trouble getting air in, the patient was having inspriatory stridor. Respondent believed that the presentation by Patient W.C. was that of someone having an allergic reaction, with some airway compromise, he refers to as laryngospasm. Respondent told nurse Haas to start an IV on the patient and get respiratory therapy to provide a racemic Epinephrine treatment. The reasons for this decision was Respondent thought the patient was having an allergic reaction. In particular, Respondent's impression at that moment was that the patient was someone having an allergic reaction to birds. Patient W.C.'s case was comparable to another case that Respondent had with a woman who had experienced an allergic reaction. In the case of the woman, the patient worsened and quickly had to be intubated. The differential diagnosis that Respondent was proceeding with was that of a patient having an allergic reaction. The orders Respondent gave concerning administration of medications were designed to alleviate an airway problem associated with an allergic reaction. Consistent with Respondent's orders, the nurse started the IV and provided medications, and the respiratory therapist came to provide the aerosol treatment. Respondent observed that Patient W.C. was sitting up in bed and did not appear to be doing anything unusual. Respondent received the report on the patient's status. Respondent went to see Patient W.C., who at that time was anxious and restless. He was having trouble getting air in and telling Respondent that he could not breathe and that his airway was closing off. Patient W.C. told Respondent that "you guys ain't helping me at all." Respondent told the patient that the treatment already provided was the normal thing that was done. Respondent got more history from the patient by asking the patient, "You were perfectly fine until an hour ago?" The response was "yes." Respondent asked the patient if he had not been sick at all. Again the response was "no." The Respondent asked the patient if he had a sore throat. The patient said a little bit. Respondent took a tongue depressor and looked in the patient's throat. It looked pretty normal. (The Emergency Physician Record indicated the patient had a sore throat.) The patient had very mild prominent lymph nodes but nothing out of the ordinary. There was still no wheezing. At that juncture, the decision was made to give Patient W.C. another aerosol treatment. In addition, the decision was made to provide antibiotics in case there was some tracheitis, pharyngitis. It was anticipated that the antibiotics would take 24 hours to have any effect. Epiglottitis was a condition at the bottom of the list on the differential diagnosis. Respondent's experience with that condition was that a patient would be sick for a period of time before the condition worsened. Nothing in Patient W.C.'s presentation led Respondent to believe that he had epiglottitis at that point. By way of history, there was no indication from the patient that he had used cocaine within 24 hours of the time of his visit to the emergency room. (Indeed subsequent toxicology studies revealed recent use of cocaine.) Had such use been reported Respondent would have acted differently in treating Patient W.C. In his second encounter with the patient on the night in question, the patient told him several times that his airway was closing off and that he believed that any second he was not going to be able to breathe. In reply, Respondent told Patient W.C. that the normal things to address his condition had been done, but there was one other thing that could be done and that would be to intubate Patient W.C. Respondent explained that it meant that they would lay the patient in a critical care room and render him unconscious and take a breathing tube and put it into his lungs and admit Patient W.C. to the hospital. This would then be followed by 24 to 48 hours of ventilatory support with use of steroids to address swelling. Patient W.C. told Respondent "let's do it quick." Respondent told a nurse to gather the standard rapid sequence medication, which in this instance involved the use of Versed and Anecitine. In the procedure room where the intubation was attempted, the procedure commenced with the patient having a good heart rate. There was a crash cart available in case there were problems. At the moment, Respondent continued to believe that the patient was experiencing an allergic reaction. Although the patient could have been experiencing epiglottitis secondary to infection, the patient did not show any signs or symptoms of that condition, indications of an on-going infection such as a fever. He was not sweating, his heart rate was not rapid. Once in the treatment room where the intubation was attempted, the patient worsened. Patient W.C. was gasping. He closed his eyes a second. The respiratory therapist Mr. Igrec experienced problems bagging the patient. Efforts by Respondent and the respiratory therapist were not succeeding in getting air into the patient. When Respondent looked in, using the laryngoscope, he noticed something that he had not encountered before. Patient W.C.'s epiglottis had the appearance of a "mushroom." It did not appear as normal anatomy. Respondent described it as a "moonscape." When Respondent looked into the patient using the laryngoscope, he describes the "picture" as looking like a scorched airway when viewing the larynx and the epiglottis. Now that he had observed the epiglottitis, Respondent decided to try and "get under it" using the ET tube. He encountered a complete blockage. Respondent then asked for a smaller tube. The smaller tube did not work. Efforts at bagging the patient were not successful. Respondent concluded that he could not intubate the patient and could not ventilate the patient in that manner, leaving him the only choice, in his perception, to deal with the obstruction by establishing a surgical airway. Respondent asked for a scalpel to perform a "cric." Respondent also told someone to call and get the surgeon and indicate that there was an airway emergency and to come immediately, as Dr. Schreiber did. Respondent took the scalpel and located the crichothyroid membrane below the crichothyroid cartilage and made an incision and air bubbled out. Respondent widened the incision, as he had been trained to do in a course dealing with trauma associated with the airway. Respondent took the ET tube that he had been using and inserted it. It went in smoothly and the treatment team was able to bag the patient. Respondent then noticed that the heart rate was dropping and that the "stats" were not coming up. Respondent then observed that the patient's neck was bigger. What had happened was that the tube had slipped out of the incision, tracking anteriorly over the trachea and the air was being introduced into the neck. Once the subcutaneous emphysema was seen in the neck, it occurred to Respondent that the tube was in the wrong place. The patient was bleeding profusely. There was an effort at reintroducing the tube but the neck had become more swollen, and the tube could not be replaced. A nursing supervisor, Tom Frith, went to the next trauma room and took one of the crichothyroidotomy kits and brought it back. Respondent was not trained to use that kit. He had seen the kits used at a demonstration. The kit was opened. Respondent took a needle from the kit and tried to find an airway but was unable to locate the airway that had been created because efforts at aspiration produced more blood. Other equipment in the kit was utilized to try to replace the endotracheal tube back in the patient, but the field would quickly fill with blood and the tube could not be placed into the membrane. When Dr. Schreiber arrived, using the skill of a surgeon, not that of an emergency room doctor, he performed an emergency tracheotomy on Patient W.C. Respondent acknowledges that persons suffering from an allergic reaction have a common presentation where they experience hives and itching. Some people have wheezing. Patient W.C. had none of these symptoms. Nonetheless, the patient appeared to Respondent to be having an allergic reaction involving the airway Respondent describes as laryngospasm. Respondent understood the patient's condition to be one in which he was able to move about and speak but he was unable to get air in. While able to compensate for that condition for awhile, that ability did not last. Respondent had never seen a patient with epiglottitis. Hypothetically, if a patient were perceived as having that condition, Respondent would consult with a surgeon or an anesthesiologist, if he had time. If confronted with classic signs of epiglottitis, Respondent would start an IV, give the patient supplemental oxygen and not attempt intubation unless the case was emergent. Given sufficient time, the patient would be taken to an operating room and an anesthesiologist could attempt intubation, failing which a surgeon would be available to address the obstruction by placing a surgical airway. This case became one of an emergency, and Respondent took the measures he deemed appropriate. Concerning notes made pertaining to treatment provided Patient W.C., that record was provided after Patient W.C. died. Given the volume of patients that were being seen in the emergency room, other patients as well as Patient W.C., five sets of records and tests were being established aside from Patient W.C. As a consequence, Respondent was doing paperwork on those patients and telling nurses what to do for Patient W.C. Only after the attempts at trying to save Patient W.C. were unsuccessful and after talking to Patient W.C.'s family did Respondent turn his attention to the medical records for Patient W.C. Expert Opinion Dr. John Murray is an emergency physician at Central Florida Regional Hospital in Sanford, Florida. He is licensed to practice in Florida and has been since 1983. He is also licensed to practice in Alabama. Dr. Murray attended medical school at the University of South Florida in Tampa, Florida. He did his residency at the University of Alabama in Tuscaloosa, Alabama. His residency was in family practice. Dr. Murray practiced in Tuscaloosa, Alabama, in emergency medicine, until four or five years ago. He then entered family practice for about three years. Following that time, he returned to practice in emergency medicine. Dr. Murray is board-certified in family practice and emergency medicine. Dr. Murray was received as an expert in emergency medicine to allow him to offer his opinion as an expert. Dr. Murray served as Petitioner's consultant in the case and was presented as its witness at hearing. To prepare himself to testify, Dr. Murray reviewed the Bert Fish hospital records relating to Patient W.C., the autopsy report, the Administrative Complaint, correspondence from Respondent's attorney, Respondent's deposition, the deposition of the nurses who treated Patient W.C. at Bert Fish, the deposition of the respiratory therapist involved with Patient W.C.'s patient care, and the toxicology report pertaining to Patient W.C. Having prepared himself Dr. Murray testified concerning Respondent's performance when measured against the expected "standard of care." In offering his opinion, Dr. Murray conformed to the expectation that Respondent's performance meet what was minimally acceptable in the standard of care. Dr. Murray does not believe that Respondent met the standard of care incumbent upon Respondent. In Dr. Murray's opinion, when a patient is seen in an emergency room the development of the differential diagnosis begins with the worse case scenario. In Patient W.C.'s case, the first consideration in the differential diagnosis should have been epiglottitis, recognizing that the main problem in the condition is inspiratory stridor, the closing of the airway or the upper airway which may cause the patient to die. Therefore, the physician should do everything possible to assure that this does not happen. Dr. Murray believes that the patient was presenting with signs and symptoms of epiglottitis when he arrived at the emergency room at Bert Fish. Dr. Murray believes that when Respondent decided to intubate Patient W.C., it should have been anticipated that there was going to be a very difficult procedure if the patient had acute epiglottitis. Sometimes the intubation fails and there is the need to provide a surgical airway. Because Respondent did not anticipate that difficulty, the intubation procedure was not properly "setup," according to Dr. Murray. That setup would envision dealing with intubation to potentially be followed by the need to provide a surgical airway. Given the possibility that the patient had epiglottitis, it was important to have the most experienced person available to perform the intubation. Dr. Murray believes that would be an anesthesiologist. Beyond that point, if the surgical airway is needed, a surgeon should be available to provide a surgical airway. Dr. Murray believes there was time to have a successful intubation, or if not, the provision of a successful airway by surgery and these arrangements were not made. Notwithstanding the patient's reported history, recognizing the symptoms present, Dr. Murray did not believe that the patient was suffering from an allergic reaction. Nothing in the medical records suggested to Dr. Murray that Patient W.C. was under the influence of cocaine when he was seen at Bert Fish. Commenting on the medical record where the term "pharyngeal erythema" was circled, Dr. Murray explained that pharyngitis is a form of infection either viral or bacterial in relation to the red or sore throat seen in the back of the throat of Patient W.C. when examined by Respondent. Respondent also made reference to lymphadenopathy both right and left, swollen lymph nodes. Patient W.C. was experiencing inspiratory stridor, difficulty in getting air in to his lungs. With inspiratory stridor, swollen lymph nodes and a red and painful throat, Dr. Murray said he would be concerned about Patient W.C.'s having an infection. Dr. Murray was concerned that if Patient W.C. had a lot of inspiratory stridor that the condition might be epiglottitis. With infection and stridor, the airway can close quickly. These circumstances could make intubation of the patient difficult, if not impossible. Dr. Murray acknowledges that epiglottitis was on Respondent's differential diagnosis for Patient W.C. Respondent's orders for use of racemic Epinephrine through nebulization and the provision of steroids, Decadron and Solu-cortef were appropriate in Dr. Murray's view. Repeating the nebulization would have been appropriate in dealing with an allergic reaction which was the number one condition treated by Respondent. Dr. Murray speaks of the use of antihistamines as well. Dr. Murray opined that as long as Patient W.C. was perceived as having an allergic airway problem, the patient would be treated with updraft treatments and antihistamines, if the patient remained stable and did not appear to be "going down hill and crashing." If the patient is "crashing," stops breathing, then a response to the condition would be necessary before the patient had respiratory arrest. However, with epiglottitis most patients would have to be intubated to protect the airway. The condition would be treated as an infection with use of an antibiotics and steroids over time while being cautious about the patient having his or her airway close off. Criticism that Dr. Murray has of Respondent's care was not the basic idea that the patient was intubated to address epiglottitis. It was the expectation that intubation need not be done unless it was absolutely an emergent circumstance, i.e., the patient had stopped breathing. If there is suspected epiglottitis, the physician should not use a tongue blade that may cause spasms or a laryngoscope. The physician should not paralyze the patient. The doctor is going to be confronted potentially with the fact that there is "no hole" to put the tube, in an attempt at intubation and it becomes necessary to "do something and get an airway in." Again the arrangement that needs to be made, in Dr. Murray's opinion, is the double setup to address the intubation and possible surgical airway. Dr. Murray does not believe that Respondent had the needed equipment to address the patient's condition when he began the intubation. In particular, the necessary equipment for the second step in the double setup, that of providing a surgical airway had not been sufficiently arranged by Respondent. Only in the instances where the patient had stopped breathing and Respondent had no time to call in other physicians would it be appropriate to paralyze the patient and attempt the intubation. Dr. Murray does not believe that the patient was dying, and there was the opportunity to call in the surgeon who was available in eight minutes, to provide assistance if one anticipates difficulty. Dr. Murray described three methods of addressing the surgical airway. One is crichothyroidotomy, which was attempted here. The second method is jet insufflation used in pediatrics but also taught for use in adults. The third method is the use of a needle with a catheter. Dr. Murray explained that if using the crichothyroidotomy is a procedure that is comfortable to the physician, then there is no necessity for redundancy beyond the use of that method for providing a surgical airway. Redundancy would be the use of the kit known as Seldinger that causes a small puncture wound. This method is a new technique, an alternative to needle crichothyroidotomy and regular crichothyroidotomy. The Seldinger method is the jet insufflation. Jet insufflation is not a common procedure in adults and is used more in pediatric care. In Dr. Murray's opinion, a reasonably prudent emergency room doctor would know of the availability of that option for ventilating a patient whether the patient is an adult or a child. Dr. Murray criticizes Respondent's medical records for Patient W.C. In his review, Dr. Murray did not find an explanation why it was necessary to intubate Patient W.C. at that moment and by the method employed. The record does not justify attempting a paralytic intubation under the existing circumstances, according to Dr. Murray. Dr. Marlon Priest, witness for Respondent, graduated from the University of Alabama with a degree in chemistry. He attended the University of Alabama School of Medicine from 1974 until 1977. He completed an internal medicine residency. From 1981 through November of 2006, Dr. Priest was on the faculty of the University of Alabama, Birmingham, Alabama, and served as a professor of emergency medicine and director of critical care transport. Over the years, Dr. Priest has had extensive experience in emergency medicine in a hospital setting. He is licensed to practice medicine in Alabama. Dr. Priest was accepted as an expert and allowed to testify concerning his opinion of Respondent's care provided Patient W.C., whether Respondent met the standard of care. Dr. Priest reviewed the Administrative Complaint, the medical records from Bert Fish concerning Patient W.C., Respondent's deposition, the deposition of Thomas Beaver, M.D., and the deposition of Michael A. Evans, Ph.D. to prepare himself to testify. He found the information sufficient to prepare to offer his opinion concerning the care provided Patient W.C. When asked whether Respondent violated the standard of care for failing to consult with or gain the assistance from an anesthesiologist or the on-call surgeon prior to inducing paralysis and attempting RSI, referring to rapid sequence intubation on Patient W.C., fell below the standard of care for an emergency room physician, Dr. Priest indicated that he felt that Respondent met the applicable standards. Dr. Priest believes emergency medicine has evolved to the point where emergency room physicians are able to assess and carryout that form of intubation. In Dr. Priest's experience, on numerous occasions, he has intubated patients without consulting a surgeon or an anesthesiologist. Based upon those insights Dr. Priest does not believe that Respondent was obligated to consult a surgeon or an anesthesiologist before attempting the intubation on Patient W.C. Specific to Patient W.C.'s case, the patient presented with shortness of breath and stridor and having failed to improve following treatment to address a possible allergic reaction, the decision was made to oxygenate the patient prior to some event where the patient could not breathe. Based upon the symptoms of the patient and gravity of the situation, Dr. Priest is persuaded that it was appropriate to attempt intubation. Concerning the allegation that Respondent failed to meet the standard of care by inducing paralysis in Patient W.C., Dr. Priest indicated that RSI is the preferred method of gaining access to a patient's airway where the patient is awake and alert and who might struggle if that method was not employed in an effort to intubate the patient. In his opinion, Dr. Priest makes mention of the progression in the case from having stridor, complaining of not being able to breathe and Dr. Priest's expectation that the airway was becoming smaller over time. Dr. Priest believes that the principal diagnosis in the differential pertaining to Patient W.C., possible allergic reaction was a reasonable diagnosis based upon information in the patient records. Concerning the allegation about Respondent's medical records related to alleged failure to document symptoms in Patient W.C. that would justify paralysis and RSI, as opposed to other less risky forms of securing the airway, Dr. Priest believes that there is sufficient evidence in the medical record to justify the intubation. Related to the second allegation dealing with record keeping by Respondent alleging that Respondent failed to document Patient W.C.'s O2 sat. and cardiac activity during the RSI attempt and subsequent procedures, Dr. Priest believes that this information would have been written down by someone else on the treatment team during the course of the treatment, the attempt to intubate. Even beyond that point, Dr. Priest believes that standard protocol would call upon the respiratory therapist or the nurse to create the record or potentially someone else on the hospital staff, not the Respondent. The inaccurate report by Patient W.C. concerning his past history with bird allergies changes the priorities in the differential diagnosis, in Dr. Priest's opinion. That history meant that allergic reaction was placed at the top of the differential diagnosis, in particular with a physical examination that was consistent with the history. Dr. Priest holds this belief even in the absence of fever, sweating, or questionable vital signs in the patient. When Dr. Schreiber entered the treatment room, he noticed a group including a physician and nurses who were attending Patient W.C. They were trying to resuscitate the patient. The patient did not have an airway. The patient was cyanotic. The patient was bloated and did not have a pulse. An attempt was being made to revive the patient from arrest. A valve bag mask was being used and drugs administered that would support the patient's blood pressure. An effort at gaining a surgical airway had not succeeded. There was a surgical incision on the patient's neck. Blood was on the patient and on the floor. At the moment no attempt was being made to establish a surgical airway. Dr. Schreiber observed that the patient had a protruding tongue that was obstructing this mouth and airway. Dr. Schreiber observed that the Petitioner's upper check and abdomen were bloated. Dr. Schreiber noted that the patient evidenced crepitancy, indicating subcutaneous air in the patient's neck and chest. This would be consistent with the placement of an airway tube into the subcutaneous tissue outside the trachea and air blown into the area. Dr. Schreiber made a nick in the trachea and placed a number 8 ET tube into the trachea. Following the placement of the ET tube in the trachea, Dr. Schreiber observed air movement in the lungs. However, the patient did not regain a pulse or adequate saturation of oxygen. On January 3, 2006, Dr. Thomas Beaver, Chief Medical Examiner and pathologist, performed an autopsy on Patient W.C. As part of his Medical Examiner's report on Patient W.C., special studies had been done, and a comprehensive toxicology analysis performed by AIT Laboratories. Dr. Beaver determined the cause of death as complications of acute epiglottitis and that the manner of death was of natural causes. The complications of acute epiglottitis were explained as a status post crichothyroidotomy. Dr. Beaver also noted atherosclerotic cardiovascular disease involving coronary arteries, mild. In particular, Dr. Beaver found that the epiglottis was swollen to an extent that it obstructed the deceased's airway. The condition observed was not the result of an attempted intubation of the patient, in Dr. Beaver's opinion. The condition observed was a disease process that Dr. Beaver felt was on-going for a matter of hours or perhaps a number of days before the attempted intubation. This type of mechanical obstruction in the epiglottitis would obstruct the airway and disable the patient from breathing, according to Dr. Beaver. The condition of the epiglottitis was not perceived by Dr. Beaver to be in association with some form of allergic reaction. The exact cause was not clear. Dr. Beaver does not believe that the ingestion of cocaine, whose metabolites were in the body caused the death. Marie Herrmann, M.D., is the present Medical Examiner and pathologist in the jurisdiction where Dr. Beaver served. Dr. Herrmann had the opportunity to review Dr. Beaver's autopsy report on Patient W.C. and to examine some evidence available to Dr. Beaver in performing his examination. She too was not persuaded that cocaine was a contributing factor to Patient W.C.'s death. In offering this opinion Dr. Herrmann was aware of the toxicology report from AIT Laboratories. Dr. Herrmann agrees with Dr. Beaver's opinion concerning Patient W.C.'s cause of death. Dr. Herrmann was unable to determine within a reasonable degree of medical certainty that the efforts by Respondent to intubate Patient W.C. caused the blockage in the airway. Michael Evans, Ph.D., is the founder, president and CEO of AIT Laboratories. He is an expert in toxicology. He testified concerning the findings in his laboratory related to Patient W.C. using established protocols for examination of the samples provided his facility. Based upon his analysis, Dr. Evans believes that Patient W.C. had ingested cocaine as recent as three hours and no longer than 24 hours before his death based upon values found in the blood and urine samples provided. Bruce Goldberger, Ph.D., is an expert in forensic toxicology. He is a professor and director of toxicology at the University of Florida College of Medicine, Departments of Pathology and Psychiatry. He is familiar with the medical examiner's report prepared by Dr. Weaver and the AIT Laboratories' report on Patient W.C. Dr. Goldberger offered the opinion that Patient W.C. could have been using cocaine a day or two before his death. He defers to the medical examiner as to the cause of the patient's death. It is accepted from the findings made in the autopsy report by Dr. Beaver that Patient W.C. died from complications of acute epiglottitis, from natural causes, not as a result of Respondent's attempt to intubate the patient. Having considered the facts and the opinions of experts, clear and convincing evidence was not presented to establish the violations alleged in Count One (Section 458.331(1)(t), Florida Statutes) paragraph 27. a). and b). related to consultation with or assistance from an anesthesiologist or the on-call surgeon prior to inducing paralysis in the patient as part of RSI. Likewise, the violation alleged in Count Two (Section 458.331(1)(m), Florida Statutes) paragraph 30. a). relating to failure to document symptoms justifying paralysis and RSI was not proven by clear and convincing evidence. Concerning the alleged violation in Count Two (Section 458.331(1)(m), Florida Statutes) paragraph 30. b). involving the documentation of Patient W.C.'s O2 sat. and cardiac activity during the RSI attempt and subsequent procedures, the opinion of Dr. Priest is compelling. Based upon that opinion Respondent would not be expected to provide that documentation and maintain the record beyond that point in time. Respondent's Background Respondent received his undergraduate education from the University of Tennessee, earning a B.S. in biology. He attended medical school in Nashville, Tennessee, at Harry Medical College and worked as an emergency physician in Tennessee. He undertook a flexible internship at the University of Tennessee in Knoxville, Tennessee. In 1987 Respondent went to Jacksonville, Florida, to do a three-year residency in pediatrics, graduating from that program in 1990. During that time he worked in local emergency rooms in St. Augustine, Palatka, and Tallahassee, Florida. He took courses in Advanced Trauma Life Support and Advanced Cardiac Life Support. Since 1990 Respondent has been a full-time emergency room physician living in New Smyrna Beach, Florida. At present, Respondent works for M. Care Emergency Services in Jacksonville, Florida. Mitigation and Aggravation Respondent has no prior violations related to his license to practice medicine in Florida. Patient W.C.'s Family Patient W.C. was married to F.C. and had two young children. At his death his daughter was approximately two-and- a-half years old and his son was 14 months old. Following Patient W.C.'s death, the family has had a difficult time coping with their loss.
Recommendation Based upon the findings of facts found and the conclusions, RECOMMENDED: That a final order be entered, which dismisses the Administrative Complaint, as amended. DONE AND ENTERED this 14th day of April, 2008, 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 14th day of April, 2008.
The Issue The issues in this case are whether Petitioner committed the alleged violations and, if so, should her paramedic license be revoked.
Findings Of Fact At all times relevant to this proceeding, Petitioner was employed as a paramedic by the City of Gulfport and worked as a paramedic for the Gulfport Fire Department. In this capacity, Petitioner worked under the auspices of the medical director for Pinellas County Emergency Medical Services (Pinellas County EMS). Petitioner was a paramedic from 1997 until March 2003. Prior to that time, from 1991 until 1997, she worked as an emergency medical technician (EMT). On February 20, 2003, Petitioner, along with Lt. Brian Campbell and Firefighter/EMT Dennis Jackson, were called to respond to the scene of a shooting. Petitioner was the only paramedic on the scene and, therefore, the only person on the scene certified by the Office of the Medical Director (OMD) to provide advanced cardiac life-saving treatment. Petitioner received the call at 12:22 a.m., and arrived at the patient's side at 12:30 a.m. When Petitioner arrived at the patient's side, she observed a white male, approximately 20 years old, lying on his back in the street. His skin color was ashen, his mouth and eyes were wide open, and his pupils were fixed and dilated. Upon physical examination, Petitioner could not detect a pulse and observed two small holes in the patient's trunk. At that point, Petitioner did not know whether the two holes represented two separate entry wounds or one entry and one exit wound. Petitioner observed a trail of blood, at least a block long, leading to the patient, but there was not a lot of blood around the patient. Petitioner attached an electrocardiogram (ECG) monitor to the patient to monitor the electrical activity of his heart. When Petitioner first turned on the ECG monitor, she observed four ticks of electrical activity within a 14-second span. Petitioner testified that based on her observation and physical examination of the patient, she believed that the electrical activity exhibited on the ECG monitor was not pulseless electrical activity (PEA), but rather "artifact" caused by her manipulation of the patient. Petitioner further testified that, thereupon, she stopped touching the patient and observed that the ECG read-out went mostly flat, showing only occasional ticks. Petitioner testified that these occasional ticks, as observed on the ECG monitor, indicated to her that the patient was in asystole. Shortly thereafter, Petitioner declared the patient dead. After Petitioner declared the patient dead, she prepared a Patient Care Report (Report or Patient Care Report) while still on the scene. In the Report, Petitioner wrote that she found a white male laying on the ground with an apparent small entrance wound in his upper chest and a possible small exit wound near his back rib. She further noted that the patient's temperature was normal, that his eyes were fixed and dilated, that he was not breathing (apneic), and that he had no discernible pulse. Petitioner also noted in the Report that the patient was in asystole within one minute after the ECG pads were attached, but she failed to note the initial four ticks she observed, which may have represented PEA. In the Report, Petitioner noted that at 12:30 p.m., the patient was hooked up to the monitor; at 12:31 p.m., he was asystolic; and at 12:32, she confirmed the patient dead. Upon completing the Report at the fire station, Petitioner attached to the Report the last of several ECG strips she had intermittently printed while at the patient's side. The ECG printout that Petitioner attached to the Report depicted a classic "flat line" indicative of asystole or no electrical activity. Petitioner discarded each of the ECG strips that contained some indicia of electrical activity. A Patient Care Report is a legal document that Petitioner is required to complete by law. By signing the Report, Petitioner acknowledged that the information contained in the Report was true and accurate. Later, on the morning of February 20, 2003, when the employees' shifts at the fire station were changing, Petitioner and Toni Lanahan (Lanahan), a firefighter/paramedic coming on duty, talked about the shooting incident. That such conversation occurred is undisputed. However, there was conflicting testimony as to what Petitioner told Lanahan during that conversation. According to Lanahan, Petitioner told her that when she (Petitioner) arrived at the scene, the patient looked dead but she hooked him up to the ECG monitor, that he had a rhythm but she did not work him, and that she turned off the monitor. Petitioner testified that she did not tell Lanahan that the patient had a heart rhythm, but only that the patient "was dead" and that she did not work him.1 About two hours after her conversation with Petitioner, Lanahan retrieved stored ECG code summary data of the patient described above.2 When Lanahan reviewed the ECG code summary, she saw that the patient had a presenting ECG rhythm showing approximately 40 beats per minute of PEA with gradually slowing PEA for the entire seven minutes depicted in intervals on the ECG summary. Based on her review of the ECG record of the gunshot wound patient, Lanahan believed that in this situation, the OMD protocols mandated that immediate resuscitative treatment be administered. Lanahan then reported these concerns to her emergency medical services (EMS) Coordinator, Lt. Marenkovic, who in turn, reported the incident to Gulfport Fire Chief Brian Brooks. Chief Brooks notified the OMD of the possible violations of its protocols by Petitioner. The OMD initiated an investigation, which included reviewing the written statements of Petitioner, Lt. Campbell, and EMT Jackson; the ECG code summary for the incident; Petitioner's Report; and the transcripts of the sworn interviews of Petitioner, Lt. Campbell, and EMT Jackson taken by the Gulfport Fire Department. After reviewing the above-referenced documents, Dr. Laurie Romig (Dr. Romig), the medical director of the Pinellas County EMS, decided to revoke Petitioner's certification. This decision was based on Dr. Romig's determination of the following: (1) Petitioner violated numerous protocols in the Medical Operations Manual, both administrative and direct patient care protocols; and (2) Petitioner attempted to make the situation appear differently from what it turned out to be, and that, apparently, she did that on purpose. Specifically, Dr. Romig charged Petitioner with violating Pinellas County Emergency Medical Services Protocol 2.3, Sections 5 and 6, and Protocol 10.8 and the following Pinellas County Emergency Medical Services Rules and Regulations: Sections XIII-3-b, related to falsification or inappropriate alteration of emergency medical services records; XIII-3-e, related to theft or dishonesty in performance of duty; XIII-3-i, related to demonstrated ability, failure or refusal to adhere to established protocols and standards as established by the authority; and XIII-3-k, related to just cause, including unbecoming behavior or unprofessional conduct reflecting a poor system image. The Pinellas County emergency protocols are written requirements that paramedics must follow when administering emergency treatment to patients. The protocols are published in a document entitled Pinellas County Medical Operations Manual, which is approved by the medical director and distributed to all Pinellas County EMS paramedics. Petitioner received a copy of the most recent medical operations manual in January 2003. EMS Protocol 5.10 prescribes treatment for patients presenting with PEA. As defined in Protocol 5.10, PEA is "any semi-organized electrical activity that can be seen on a monitor screen although the patient lacks a palpable, radial, brachial, or carotid pulse." When PEA is present in a patient, Protocol 5.10 mandates that immediate life-saving treatment be implemented. The patient initially had electrical activity. Nonetheless, Petitioner did not follow Protocol 5.10. According to Petitioner's testimony, she believed that the patient was asystolic and, thus, the protocol related to PEA was inapplicable to the shooting victim. Petitioner's belief was not supported by the ECG report. Protocol 5.4 delineates the procedures to be followed in the treatment of asystole. In the book utilized for Pinellas County EMS paramedic training, "asystole" is defined as a cardiac arrest rhythm associated with no discernible electrical activity on the ECG ("flat line"). Significantly, Protocol 5.4 and Protocol 5.10, discussed in paragraph 21, require that resuscitative efforts be started immediately and that such resuscitative efforts and treatment be terminated by the paramedic only "after 10 minutes of continuous asystolic arrest with appropriate interventions." Even if Petitioner's assertion that the patient was asystolic is accepted, she failed to provide the required resuscitative efforts and/or treatments prescribed by Protocol 5.4. Petitioner did not prematurely terminate resuscitative efforts, she never implemented them. Protocol 5.15 prescribes the treatment and transport considerations for "patients with cardiac arrest secondary to trauma, regardless of presenting cardiac rhythm." The protocol provides that such patients should be transported to the closest hospital emergency facility. Contrary to the requirements in Protocol 5.15, the patient was not transported to a hospital emergency facility. Protocol 2.3 requires paramedics, when possible, to contact and consult with On-line Medical Control (OLMC) in any case in "which a deviation from protocol has been made intentional or otherwise." The OLMC is a system which allows paramedics to contact the OMD and consult with a medical doctor regarding a situation in the field. Petitioner clearly deviated from Protocols 5.4 and/or 5.10, by failing to initiate and implement the resuscitation procedures required by both protocols, and Protocol 5.15, by failing to have the patient transported to a hospital emergency facility, yet she never contacted the OLMC as mandated by Protocol 2.3. Petitioner acknowledged that she did not follow either Protocols 5.4 or 5.10, both of which required immediate resuscitative efforts. Petitioner testified that instead, she followed Protocol 10.8, which provides an exception to the protocols that require initiation of resuscitative efforts. Petitioner contends that Protocol 10.8 provided the basis for her withholding resuscitation from the patient. Protocol 10.8 requires that cardiopulmonary cerebral resuscitation (CPCR) be initiated "in all cases when the patient is found in cardiopulmonary arrest unless one of the exclusion or special situation criteria applies." The exclusion criteria provides that CPCR may be withheld if the patient has, "in conjunction with apnea, pulselessness and asystole on the ECG," an "obviously unsurvivable trauma." If CPCR is withheld, Protocol 10.8 requires that exclusion criteria be fully documented and described. Protocol 10.8 does not define "obviously unsurvivable trauma." However, according to Dr. Romig, the term connotes catastrophic injuries observable by an untrained eye. Dr. Romig, an expert in emergency medicine and traumatic cardiac arrest, testified that nothing about this patient, based on her review of the records and documents, indicated that the patient had suffered an "obviously unsurvivable trauma." Also, Lt. Campbell, an EMT certified for 12 years, who was at the scene, testified that although the patient "looked dead," he could not say that the patient suffered an "obviously unsurvivable trauma" because the patient showed only a small bullet wound to the chest and a "little bit" of blood on his (the patient's) clothing. The weight of the evidence showed that the patient had not suffered an obviously unsurvivable trauma. However, even accepting Petitioner's testimony that she believed that the patient had suffered an obviously unsurvivable trauma, she failed to comply with Protocol 10.8. If Petitioner, in fact, relied on Protocol 10.8 in deciding to not administer CPCR, she was required to document and describe the exclusionary criteria, which was the basis of her decision to withhold CPCR. Petitioner failed to provide any such documentation and, thus, violated Protocol 10.8. In addition to violating the above-noted protocols, Petitioner was dishonest in the performance of her duties as a paramedic and also falsified EMS records. The ECG summary showed that despite the patient's having electrical cardiac activity of at least 40 beats, Petitioner turned off the ECG machine and pronounced the patient dead. After pronouncing the patient dead, she then turned the ECG machine on again, and intermittently printed activity on four separate occasions until reaching a reading showing no electrical cardiac activity. By engaging in this conduct, Petitioner was dishonest in the performance of her duties. Paramedics are required to truthfully and accurately complete the Patient Care Records of patients for whom they provide emergency medical services. Here, the ECG summary showed PEA of over 40 beats per minute initially and diminished electrical activity for over eight minutes total, six minutes of which were after Petitioner had already pronounced the patient dead. Petitioner initially saw a rhythm of four beats or ticks in a 14-second period, which was a beat rate of 40 and showed on the ECG strip as 42. Although the initial reading of approximately 40 beats and PEA was clearly visible during the entire nearly eight minutes depicted on the six-second intervals shown on the ECG code summary, this was omitted from Petitioner's Report. Petitioner omitted from the patient's Record the ECG readings that showed electrical activity. Instead, Petitioner reported that at the time she declared the patient dead, he was in "asystole" when, in fact, the ECG summary showed PEA. Moreover, Petitioner documented the Report with an asystole ECG strip reflecting a "flat line" reading printed some six or seven minutes after the reported time of death.3 Petitioner admitted during her sworn statement and at this proceeding that she deliberately did not attach to the Report any part of the ECG strip that reflected the interim electrical activity. Petitioner testified that the ECG strips showing interim electrical activity could raise doubts about the propriety of the treatment she gave this patient in a future criminal trial or other investigation.4 The medical director is required by law to ensure that Pinellas County EMS personnel provide quality care and are not a danger to the safety of the county's citizens, residents, or visitors. Here, Petitioner violated the protocols related to the standard of care for patients and completion of reports and rules and regulations related to dishonesty in the performance of duties and to falsification of records. These infractions are a possible threat to public health and safety of residents of and visitors to Pinellas County. As such, they constitute just cause to conditionally revoke Petitioner's Pinellas County Paramedic Certificate. The conditional revocation allows Petitioner to reapply for a paramedic certificate in two years. Such recertification may include a one-year probationary period, with monitoring by the medical director to include a review of all trauma-run reports. Petitioner's Pinellas County Emergency Medical Technician Certification was not revoked and she retains that certification.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that Respondent enter a final order finding Petitioner guilty of the violations alleged in the Notice of Revocation dated March 28, 2003, and upholding revocation of Petitioner's Pinellas County Paramedic Certificate. DONE AND ENTERED this 1st day of October, 2003, in Tallahassee, Leon County, Florida. S CAROLYN S. HOLIFIELD 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 1st day of October, 2003.
The Issue The issue for determination is whether Respondent committed the offenses set forth in the corrected administrative complaint, and, if so, what action should be taken.
Findings Of Fact At all times material hereto, Kenneth Douglas Glaeser (Respondent) was a licensed physician in the State of Florida, having been issued license number ME 0058606. Respondent's area of specialty is Emergency Medicine. On or about May 30, 1993, at approximately 9:45 p.m., Patient L. H., a 47 year old male, presented to the emergency room (ER) at Parkway Regional Medical Center (PRMC) in Miami, Florida complaining of chest pain. Patient L. H. and his wife were visiting his mother in Miami. At first, Patient L. H. believed he had heartburn, but it would not go away. His mother convinced him to go to the hospital. Patient L. H.'s wife and mother accompanied him to the hospital. His wife parked the vehicle while Patient L. H. and his mother entered the ER. Patient L. H.'s wife completed paperwork for the ER while the ER staff attended to her husband. Patient L. H.'s mother was with him. After completing the paperwork, approximately 10 minutes later, Patient L. H.'s wife joined Patient L. H. and his mother in the examining room. At the time, Respondent was the ER physician on duty at PRMC. Respondent was the only ER physician who attended to Patient L. H. Respondent has no independent recollection of Patient L. H. or what happened during Patient L. H.'s visit to the ER at PRMC. The first goal of an ER physician is to determine if the patient has a life-threatening condition, which, often times than not, involves excluding diagnoses. The second goal of an ER physician is to determine if the patient has a condition which can receive immediate treatment and to provide that immediate treatment whether the condition is life-threatening or not. Respondent obtained Patient L. H.'s history which included the type of pain, description of the pain, location of the pain, associated symptomatology, time frame of the pain (including onset), and past history. Respondent recorded, among other things, that Patient L. H. had chest pressure which radiated bilaterally to his shoulders and a numb left shoulder; that the pain lasted for approximately 10-15 minutes, subsided, and re-occurred 30 minutes later; that Patient L. H. had no shortness of breath, diaphoresis (sweating), nausea or vomiting, or palpitations; and that Patient L. H. had no cardiac history. Respondent's history of Patient L. H. was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent performed a physical examination on Patient L. H. The physical examination included taking vital signs and examination of the cardiovascular system, lungs, and pulses of the extremities. Respondent's physical examination was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent had laboratory work performed on Patient L. H. Respondent ordered SL (sublingual) nitroglycerine for Patient L. H. But, the nitroglycerine was not administered because Patient L. H. was not complaining of chest pains at the time. The ordering of the nitroglycerine and not administering it until chest pain developed was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent ordered diagnostic tests to be performed on Patient L. H. The tests included an electrocardiogram (EKG), a chest x-ray, and cardiac enzymes. Neither Patient L. H.'s wife nor his mother were present during the tests. ER physicians are trained to read EKGs. Generally, a cardiologist is not immediately available to the ER for the reading of EKGs. An ER physician looks for an injury pattern in the EKG, which would evidence an acute cardiac event. Most times, a cardiologist will over-read the EKG a day or two after the EKG is performed on a patient. Respondent's reading of Patient L. H.'s EKG did not show an injury pattern which would evidence an acute cardiac event. Respondent determined that Patient L. H.'s EKG was within normal limits. Even though an abnormality was demonstrated in the EKG, the abnormality could have been a false/positive reading. Respondent's reading of the EKG was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. A cardiologist over-read Patient L. H.'s EKG after he left PMRC. The cardiologist found a "definite abnormality." Respondent's reading of Patient L. H.'s chest x-ray indicated that it was within normal limits. Respondent's reading of the chest x-ray was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent's interpretation of the cardiac enzymes tests (CPK and LDH) indicated that they were within normal limits. If a heart is damaged, often times the enzymes contained in the heart cells will be released, and the cardiac enzymes tests would detect the enzymes. Respondent's interpretation of the cardiac enzymes tests was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. It is undisputed that based upon Patient L. H.'s history, the physical examination, the tests results, including diagnostic and laboratory results, a recommendation to Patient L. H. by Respondent for admission to PRMC was medically warranted. Admission would allow for monitoring and further evaluation. However, a patient has a right to refuse admission. Respondent discussed his findings with the doctor who was listed as Patient L. H.'s primary physician on the ER record. The primary physician was the private physician, a cardiologist, of Patient L. H.'s mother. The primary physician authorized Respondent to contact the physician on-call. Respondent discussed his findings and his concern with Patient L. H. Respondent recommended to Patient L. H. that he be admitted to PRMC. However, Patient L. H. did not wish to be admitted; he wanted to leave the hospital. Patient L. H. rejected Respondent's recommendation for admission to PRMC. 1/ Patient L. H.'s mother attempted to convince him to agree to admission and remain in the hospital, but he refused. It is undisputed that if a patient refuses admission, the physician should advise the patient of the risks involved and recommend admission. In Patient L. H.'s circumstances, it was medically warranted that Respondent advise Patient L. H. that, if he was not admitted, he could suffer a heart attack and die and recommended admission to Patient L. H. Taking the totality of the circumstances, an inference is drawn and a finding is made that Respondent advised Patient L. H. of the risks involved if he rejected admission and recommended to Patient L. H. that he be admitted. Respondent did not record in the ER record that he advised Patient L. H. of the risks involved in rejecting admission and recommended admission. ER physicians are not medically required to spell-out in the medical record what risks are discussed with a patient and that the patient left against medical advice. It is sufficient that the ER physician explains the risks to the patient. Respondent ordered a GI cocktail (Maalox, Donnatal, and viscous Lidocaine) for Patient L. H. 2/ The GI cocktail was not administered until approximately 12:15 a.m. on May 31, 1993. 3/ The ordering or not of the GI cocktail for or the time in which the GI cocktail was given to Patient L. H. has no effect on the standard of care that Respondent provided to Patient L. H. Respondent diagnosed Patient L. H.'s condition as atypical chest pain. This diagnosis essentially indicates that a number of different things may have been causing Patient L. H. to experience chest pain. Patient L. H. left PRMC on May 31, 1993, at approximately 12:20 a.m. against medial advice even though the ER record indicates that he was discharged. 4/ Before leaving PRMC, Patient L. H. was informed by Respondent to, among other things, follow-up with the primary physician and return to the ER if needed. Neither Patient L. H. nor his wife completed any discharge papers or received discharge instructions. It is not uncommon for a patient to be discharged from a hospital without completing discharge papers or receiving discharge instructions. However, hospitals attempt to prevent such occurrences. When a patient leaves PRMC against medical advice, the patient is requested to complete certain documentation. That documentation was not completed in the case of Patient L. H. However, the absence of the documentation is not considered to evidence that Respondent failed to advise Patient L. H. of the risks involved in rejecting admission and to recommend admission. On May 31, 1993, at approximately 8:45 a.m., Patient L. H. went into cardiac arrest at his mother's home. He was transported to the ER at PRMC by emergency vehicle, where he was pronounced dead. On June 1, 1993, Respondent entered an addendum to the ER notes of May 30 and 31, 1993. The addendum provided, among other things, that Patient L. H. was opposed to admission to PRMC and that, even when Respondent explained the risks to Patient L. H., he continued to oppose admission and wanted to leave. Furthermore, the addendum provided, among other things, that Respondent instructed Patient L. H. to return to the ER if the chest pain returns and to follow-up with the primary physician. An addendum to ER notes by an ER physician is not unusual and is an accepted practice. The Dade County Medical Examiner determined that Patient L. H.'s cause of death was occlusive coronary artery disease. Respondent's medical records justified the course of treatment of Patient L. H. Respondent practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent is a defendant in a pending civil suit brought by Patient L. H.'s surviving spouse.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine dismiss the corrected administrative complaint. DONE AND ENTERED in this 27th day of January 1997 in Tallahassee, Leon County, Florida. ERROL H. POWELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 27th day of January 1997.
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 presented for decision in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on July 28, 1998.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license no. ME 0031639 on October 26, 1977. Respondent is board certified in general surgery and has worked and trained as a general and vascular surgeon. Respondent has practiced medicine in Tampa since 1988. Respondent offered testimony establishing that his peers respect his ability as a surgeon. Until 1996, Respondent had not been the subject of disciplinary action by the Board of Medicine or by any other licensing entity. On January 26, 1996, the Board of Medicine issued a final order in Division of Administrative Hearings Case No. 95-3925, imposing discipline on Respondent’s license to practice medicine. Case No. 95-3925 involved two separate incidents in which Respondent performed surgical procedures that had not been specifically consented to by the patients. In the first incident, Respondent removed the severely diseased left leg of the patient when the signed consent to surgery was for removal of the right leg. The patient was well known to Respondent, and it was understood between Respondent and the patient that both legs would eventually require amputation. In the second incident, Respondent removed a toe that had become dislocated during a debridement of the patient’s foot. The toe was connected only by ligament and necrotic tissue, and Respondent removed it during the debridement procedure rather than waiting to obtain specific consent for its removal. In the final order, the Board of Medicine concluded that Respondent had violated Sections 458.331(1)(p) and (t), Florida Statutes, by failing to obtain proper consent from a patient and by practicing medicine below the standard of care. Based on these conclusions, the Board of Medicine imposed the following relevant disciplinary measures: Respondent’s license to practice medicine is REPRIMANDED. Respondent shall pay an administrative fine in the amount of $10,000 to the Board of Medicine, within one year of the date this Final Order is filed. Respondent’s license to practice medicine in the State of Florida is SUSPENDED for a period of 6 months including the time served under the emergency suspension. Respondent shall submit a practice plan prior to reinstatement to be approved by the Board’s probation committee. Within 6 months of the effective date of this Final Order, Respondent shall have an independent, certified risk manager review Respondent’s practice. Specifically, this independent consultant shall review the Respondent’s practice concerning preoperative procedures including patient consent. This consultant will prepare a written report addressing Respondent’s practice. Such report, if necessary, will include suggested improvements of the quality assurance of Respondent’s practice. Respondent will submit this report to the Board’s Probation Committee with documentation that demonstrates compliance with the suggestions enumerated in the consultant’s report. Upon reinstatement, Respondent’s license to practice medicine in the State of Florida shall be placed on PROBATION for a period of two years, subject to the following terms and conditions: Respondent shall comply with all state and federal statutes, rules and regulations pertaining to the practice of medicine, including Chapters 455, 458, 893, Florida Statutes, and Rules 59R, Florida Administrative Code. Respondent shall appear before the Probation Committee at the first meeting after said probation commences, at the last meeting of the Probation Committee preceding termination of probation, quarterly, and at such other times requested by the committee. Respondent shall be noticed by the Board staff of the date, time and place of the Board’s Probation Committee whereat Respondent’s appearance is required. Failure of the Respondent to appear as requested or directed shall be considered a violation of the terms of this Probation, and shall subject the Respondent to disciplinary action. * * * 6. Respondent shall not practice except under the indirect supervision of a physician fully licensed under Chapter 458 to be approved by the Board’s Probation Committee.... The responsibilities of a monitoring physician shall include: Submit quarterly reports, in affidavit form, which shall include: Brief statement of why physician is on probation. Description of probationer’s practice. Brief statement of probationer’s compliance with terms of probation. Brief description of probationer’s relationship with monitoring physician. Detail any problems which may have arisen with probationer. * * * Respondent shall submit quarterly reports in affidavit form, the contents of which shall be specified by the Board. The reports shall include: Brief statement of why physician is on probation. Practice location. Describe current practice (type and composition). Brief statement of compliance with probationary terms. Describe relationship with monitoring/supervising physician. Advise Board of any problems. * * * 11. Respondent understands that during this period of probation, semi-annual investigative reports will be compiled by the Agency for Health Care Administration concerning his compliance with the terms and conditions of probation and the rules and statutes regulating the practice of medicine. On January 31, 1996, Respondent submitted to the Board of Medicine the practice plan required by the final order. The practice plan named Joseph Diaco, M.D., as Respondent’s monitoring physician, and stated that Dr. Diaco would review twenty percent of Respondent’s patient charts. The practice plan stated that Respondent would comply specifically with all the terms and conditions of the final order, and with the recommendations of the certified risk manager. The practice plan further stated: ... Dr. Sanchez will have specific discussions with his surgical patients prior to any anesthesia being administered, wherein he will discuss the intended surgical procedure again, and will have the intended surgical site marked with indelible ink. The record does not document that the Board of Medicine’s Probation Committee formally approved Respondent’s practice plan, or addressed the terms of the practice plan in any way. Such approval is presumed from the fact that Respondent appeared before the Probation Committee on several occasions subsequent to filing the practice plan, and the record does not indicate that the Probation Committee registered any objection or suggested any modifications to the practice plan. Respondent made the required appearances before the Probation Committee. Respondent and Dr. Diaco submitted the required quarterly reports to the Board of Medicine, and Dr. Diaco fulfilled the monitoring requirements of the practice plan. Periodically during the probation period, Mr. Richard Hess, an investigator with the Agency for Health Care Administration, would contact Respondent and Dr. Diaco to inquire as to Respondent’s practice and compliance with the terms of probation. Mr. Hess would inquire regarding such matters as the submission of quarterly reports, the payment of the administrative fine, and the current locations at which Respondent was practicing. Mr. Hess would submit his reports to the Agency for Health Care Administration and to the Board of Medicine, and these reports were used to supplement the information submitted directly by Respondent and Dr. Diaco. Based upon the information he was provided by Respondent and Dr. Diaco, Mr. Hess never found Respondent out of compliance with the terms of his probation. On the morning of November 2, 1997, an order was entered at Vencor Hospital by the primary treating physician for placement of a central venous line for patient D.M., an 80 year- old female patient. A central venous line is most often placed for access to the circulatory system for the provision of medications and/or fluids when the peripheral venous system is not available for such use. A central venous line may be ordered if the patient has no veins remaining for the insertion of a peripheral catheter, or for extended access, such as when a patient requires a long-term cycle of antibiotics for a bone infection. Patient D.M. required the central line for antibiotics to treat infected ulcerations on her lower extremities. The placement of a central line may be performed by any licensed physician, though surgeons are often called in to perform the procedure for primary physicians. Two physicians who teach at the University of Miami testified that third-year residents are allowed to perform the procedure with only indirect supervision. Dr. Diaco testified that nurse practitioners may perform the procedure under the supervision of a physician. The procedure is performed at the patient’s bedside, not in an operating room. No general anesthesia is required. A local anesthetic is administered at the point of insertion. The entire procedure takes two to three minutes to perform. The central line may be placed in at least three locations in the body: the leg, the neck, or the collarbone. In the case of D.M., Respondent placed the line by way of the collarbone. A needle is inserted under the clavicle and into the vein that unites with the jugular vein to form the second largest vein in the human body, the superior vena cava. Using a guide wire, a catheter is threaded through the subclavian vein and placed inside the superior vena cava. Prior to performance of the procedure, the patient’s head is typically placed lower than her feet in what is called the Trendelenburg position. If the patient has a feeding tube, it is typically turned off prior to the procedure to prevent aspiration of tube material. Proper placement of the central line is confirmed by X- ray taken immediately after the procedure. Such confirmation of placement is necessary due to the risks associated with incorrect placement. The most immediate risk is pneumothorax, the puncturing of the patient’s lung. Other less common complications are blood loss, cardiac arrest, infection, and irregular heartbeat. The consensus of the experts who testified at hearing was that the procedure poses no greater risk of complication for elderly patients such as D.M., but that elderly patients who do suffer complications may have a harder time recovering than would younger, more robust patients. D.M. was an 80 year-old female patient who shared Room 218 at Vencor Hospital with J.P., an 89 year-old female patient. D.M. and J.P. were of the same general age, ethnic origin, and gender. They had similar medical problems, including bilateral lower extremity decubiti and ulcerations. D.M. was able to understand conversation and could verbally communicate with staff. D.M. signed on her own behalf the consent form for the insertion of the central venous line. The signature on the consent form was obtained by and witnessed by Elizabeth Rood, a registered nurse on duty during the day of November 2, 1997. Ms. Rood testified that she believed D.M. was rational enough to sign the form on her own behalf. Vencor Hospital policy dictated that informed consent be obtained from the patient by the surgeon who was to perform the procedure. The nursing employees of Vencor Hospital and Respondent all testified that, despite the stated policy, it was common practice at the time for nurses to obtain the signatures of patients on the consent forms. The express terms of Respondent’s practice plan also required Respondent to have “specific discussions with his surgical patients prior to any anesthesia being administered. ” J.P. suffered from organic brain syndrome and was generally unable to communicate verbally. J.P. was unable to give consent for surgical procedures on her own behalf. Ms. Rood obtained D.M.’s signature on the informed consent form at about 10:00 a.m. Shortly thereafter, hospital staff contacted Respondent to inform him of the order and request that he perform the placement of the central line. Respondent replied that he was unable to perform the procedure at that time because of a more urgent consultation at St. Joseph’s Hospital, but would come to Vencor Hospital later to perform the procedure. Shortly before the start of the nursing night shift, the central line cart with supplies for the procedure was brought by the day supervisor to the second floor of Vencor Hospital and placed outside Room 218. Lisa Cotroneo was the night charge nurse. When she arrived for her shift, she received report from the day charge nurse. That report indicated that D.M. was to receive a central line placement at some time during the evening. The nursing staff at Vencor was divided into teams of two or three nurses assigned to particular rooms on the floor. Team three was responsible for Room 218. At the start of the night shift, Nurse Cotroneo informed two of the three nurse on team three, Donna Maranto and Fortune Ndukwe, that a central line was to be placed on patient D.M. that evening. Nurse Cotroneo did not inform the third nurse, Mary Shogreen, because Nurse Shogreen was a pool nurse called in to work on short notice and had not yet arrived for her shift. Nurse Shogreen was the nurse on team three who was assigned primary care duties for the patients in Room 218. Nurse Shogreen was later informed by Nurse Ndukwe that one of her patients would be receiving a central line placement that evening. Nurse Shogreen testified that she intended to check with the charge nurse to confirm the order for a central line placement, but that she never did so. At around 8:00 p.m., Respondent telephoned the nursing unit to inform the charge nurse that he was on his way to perform the placement of the central line. Nurse Cotroneo conveyed this information to Nurses Maranto and Ndukwe, and told them to be sure everything was ready for Respondent’s arrival. Respondent arrived at Vencor Hospital shortly after 8:00 p.m. and proceeded to the second floor nursing station, where he asked for and received the chart for patient D.M. He reviewed the chart, which contained the signed consent form and the order for placement of the central line. After reviewing the chart, Respondent inquired as to the location of D.M. and the nurse who would assist him in the procedure. Respondent was told that D.M.’s nurse was down the hall. Respondent walked down the hall and approached a group of three or four nurses. Respondent did not know any of them. He informed the group that he was Dr. Sanchez and was there to perform the central line placement. One of the nurses, later identified as Mary Shogreen, told him she was ready for him. She led him down the hall toward Room 218. Respondent paused at the central line cart outside Room 218 to pick up a pair of surgical gloves and the kit used for the central line placement. When Respondent entered the room, he observed Nurse Shogreen already at the bedside. The room was dark, save for a single light over the bed of the patient where Nurse Shogreen was working. Respondent saw that Nurse Shogreen was turning off the feeding tube to the patient, a common precursor to performance of a central line placement. Respondent walked to the other side of the patient’s bed and addressed the patient by the name of D.M. He told her that he was Dr. Sanchez and that her physician had asked him to insert a central venous catheter in her. Respondent looked into the patient’s eyes and realized she was not comprehending what he said. Nurse Shogreen was standing directly across the bed and could hear Respondent’s efforts to talk to the patient, including his addressing that patient as “D.M.” Respondent asked Nurse Shogreen if the patient was “always like this,” i.e., unresponsive. Nurse Shogreen answered that she had never had the patient before, but believed that was the usual condition of the patient. It would not be unusual for an elderly patient such as D.M. to be communicative and able to understand and sign a consent form at 10:00 a.m., but then be uncommunicative in the evening. The medical community informally refers to this phenomenon as "sundown syndrome." Respondent told Nurse Shogreen to assist him in placing the patient in the Trendelenburg position, and to get a rolled towel to place between the patient’s shoulder blades. While Nurse Shogreen was getting the towel, Respondent examined the patient’s neck and chest. Nurse Shogreen returned with the towel, but was unable to adjust the bed into Trendelenburg position. Respondent told her to go get another nurse who knew how to work the bed. She brought in Nurse Ndukwe, who was also unable to get the bed into the proper position. At length, they found a certified nurse assistant who was able to place the bed into position. Neither Nurse Shogreen nor Nurse Ndukwe expressed any concern to Respondent regarding the identity of the patient. Nurse Ndukwe had received an explicit report concerning the fact that patient D.M. was to receive a central line placement. Nurse Shogreen had heard Respondent address the patient as D.M. Respondent completed the procedure, which took about one minute. He proceeded to the nurse’s station and ordered the standard X-ray to confirm the proper placement of the central line, completed the consult form, and dicated both his consultation report and operative report. Nurse Shogreen remained behind in the room to clean up after the procedure. She made notations in the bedside chart of patient J.P., the mistaken recipient of the central line. Even at this point, Nurse Shogreen did not realize that the wrong patient had received the central line. The findings as to events in Room 218 on the evening of November 2, 1997, were based on the testimony of Respondent. Nurse Shogreen testified that it was Respondent who led the way into the room, Respondent who proceeded to the wrong bed, and Respondent who prevented Nurse Shogreen from going out to get the patient’s chart to confirm her mental condition after questioning by Respondent. Nurse Shogreen agreed with Respondent’s version of the problems with getting the bed into proper position, but testified that Respondent was so angry and in such a hurry that he performed the central line placement before the staff was able to place the bed in the proper position. Based on both the substance of the testimony and the demeanor of the witnesses, it is found that Respondent’s version of events is more believable, and that Respondent is a more credible witness than Nurse Shogreen. The undersigned is unable to credit testimony that a physician of Respondent’s skill and experience would plunge ahead into the room and commence a procedure on a patient he had never seen, without doing anything to ascertain her identity. The undersigned finds it more plausible that Respondent followed Nurse Shogreen’s lead, observed the visual cues she was providing, and assumed that the patient to whom Nurse Shogreen attended was in fact patient D.M. Respondent's proffer of testimony regarding inconsistencies in Nurse Mary Shogreen's testimony before the Peer Review Committee was disregarded in formulating these findings of fact. Several physicians offered expert testimony as to whether it is within the standard of practice for a surgeon to rely on his assisting nurse for patient identification. Dr. David Shatz, an associate professor of surgery at the University of Miami, testified that any surgeon must be absolutely sure he is working on the right person. He testified that once Respondent was unable to get a verbal response from the patient, he should have asked the nurse if he was speaking to patient D.M. Dr. Shatz concluded that it is a deviation from the standard of care to perform a procedure on a noncommunicative patient without checking the patient’s identification bracelet. Dr. Stephen Michel agreed that Respondent failed to meet the standard of care by placing the central line in the wrong patient. Dr. Michel’s other conclusions regarding the events in question cannot be credited because he admitted he was assuming that Dr. Sanchez was not permitted by the terms of his probation to be working in Vencor Hospital at all. This assumption was incorrect, and colored the remainder of his conclusions. Dr. Enrique Ginzburg, also an associate professor of surgery at the University of Miami, testified that a surgeon is usually unfamiliar with the patient in a central line placement, and stated that he could not remember the last time he checked an identification bracelet when the nurses were in the room with him. He agreed that it would be easy to check the armband, but that physicians simply do not check the armband if nurses are present to identify the patients. Dr. Jerry Diehr, an anesthesiologist at St. Josephs Hospital in Tampa, testified that a reasonably prudent physician would do what Respondent did. He stated that he relies on nurse identifications in similar circumstances, and that it is common practice for physicians to do so. Dr. Diehr testified that physicians rely on nurses for all manner of patient identification. He noted that care is often dictated by telephone calls. When a nurse calls him and tells him about the condition of his patient, the underlying assumption is that the nurse has correctly identified the patient and adequately reported the condition. Physicians may base their entire course of treatment on such reports from nurses, and must be able to rely on the nurses for such identification and reporting. Dr. Diaco strongly opined that physicians must be able to rely on nurses for patient identification. It is the nurse’s responsibility to identify the correct patient when the physician does not know the patient. Dr. Diaco testified that if physicians cannot rely on nurses for such basic information as the identity of their patients, they may as well live in the hospital and administer their own medications. Peter Shute, an expert in general nursing practice, opined that the three nurses on duty at Vencor Hospital on the evening of November 2, 1997, were negligent in their duty to know the patients on their assigned unit. He testified that Nurse Shogreen was particularly negligent, because she had not received full report on her patients, found out that one of her patients was to receive a central line placement that evening, but did not immediately obtain a full report and take steps to ensure that all preparations had been made. The weight of the evidence is that it was within the standard of care under the conditions and circumstances for Respondent to rely on Nurse Shogreen’s identification of the patient. This finding does not minimize the fact that Respondent bears ultimate responsibility for the performance of an invasive procedure on a patient who did not give informed consent. After Respondent dictated his notes and left the hospital, David Vallejo, the X-ray technician, came to the floor to obtain the X-ray ordered by Respondent. He discovered that the patient who received the central line was J.P., not D.M. Mr. Vallejo went to the nurse’s station and informed Nurse Cotroneo, who called the nursing supervisor to come to the room with her. Nurse Cotroneo and the supervisor confirmed that both patients in Room 218 were wearing their identification bracelets. The nursing supervisor called J.P.’s primary physician, who ordered an X-ray, which confirmed that J.P. suffered no ill effects from the placement of the central line. He also ordered removal of the central line, which was accomplished without incident. Respondent was informed of the error by telephone. He came to Vencor Hospital the next day, November 3, 1997, and documented the error in the medical records of both D.M. and J.P. On that day, a different surgeon performed the central line placement on D.M. All of the expert witnesses agreed that Respondent’s charting and recording of the incident, both before and after he learned of the error, were adequate and indicated no effort to conceal the facts of the situation. The experts also agreed that marking the intended surgical site with indelible ink serves no purpose in a central line placement. Petitioner's own expert, Dr. Shatz, stated that marking the site of a central line placement would be "silly." On November 3, 1997, Vencor Hospital suspended Respondent’s hospital staff privileges pending an investigation of the incident. Respondent immediately contacted Dr. Diaco, his indirect supervisor, as soon as he learned of the error. Respondent fully informed Dr. Diaco of the facts of the situation. Dr. Diaco told Respondent that he did nothing wrong and that “the nurse is in big trouble.” Respondent also sought the counsel of his attorney, Michael Blazicek. Mr. Blazicek conferred with Dr. Diaco, and also concluded that this was a nursing problem, not a standard of care problem for Respondent. The results of the hospital’s internal Peer Review Committee review seemed to bear out the opinions of Dr. Diaco and Mr. Blazicek. On November 26, 1997, Respondent was restored to full privileges at Vencor Hospital. Nurse Shogreen received verbal counseling and a one-day suspension for failure to render proper treatment to the correct patient. Vencor Hospital’s “Root Cause Analysis Team” found that nursing protocols should be changed to prevent a recurrence of patient misidentification. Patients would henceforth be identified by bed letter designation. Identification of the patient and consent to treatment would be verified by two people, one of whom must be a hospital employee. On November 17, 1997, the quality review manager of Vencor Hospital submitted an Adverse or Untoward Incident Report (Code 15) regarding the incident, pursuant to Sections 395.0197(6) and 641.55(6), Florida Statutes. A Code 15 Report is a report of serious adverse incidents in licensed facilities. The Code 15 Report identifies the physicians and nurses involved by their license numbers, and identifies the patient and facility. It describes the nature of the incident and all actions taken by the hospital in response to the incident. The purpose of the Code 15 Report is to notify the Agency for Health Care Administration and the Department of Health within 15 days of a serious adverse incident so the Agency may review the incident and begin an investigation. Respondent appeared before his Probation Committee on November 13, 1997. At this time, Respondent knew that the hospital would be filing a Code 15 Report, though it had not actually done so. Respondent was still on summary suspension at Vencor Hospital, pending review. Prior to his Probation Committee appearance, Respondent conferred with his attorney, Mr. Blazicek, who counseled him to answer any questions forthrightly, but not to volunteer information about the incident to the Probation Committee. This advice was based on the facts that the incident was still under investigation, that there had been no finding of wrongdoing by Respondent, and that summary suspension was a standard procedure for such incidents indicating no conclusions as to ultimate responsibility. Mr. Blazicek testified that he knew Respondent still had one more written quarterly report to file in January 1998. He reasoned that if the hospital's investigation resulted in adverse findings, Respondent could report the incident in that later filing. The Probation Committee raised no questions as to the Vencor Hospital incident, and determined that Respondent’s probation would terminate as scheduled upon payment of the administrative fine. Respondent did not volunteer information about the incident or the summary suspension. Respondent and Dr. Diaco filed their final quarterly reports in January 1998. Neither of them reported the Vencor Hospital incident. Respondent reported that he was in full compliance with all probationary terms. By the time the final quarterly reports were received, the Department of Health was aware of the Code 15 Report. Nonetheless, the Department issued an Order of Termination on February 2, 1998, finding that Respondent had satisfactorily completed the term of his probation as of January 26, 1998.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is recommended that the Department of Health, Board of Medicine enter a final order determining that Rolando R. Sanchez has violated Section 458.331(1)(p), Florida Statutes, and suspending his license for a period of nine months from the date of the Order of Emergency Suspension of License, imposing a fine of $2,500.00 and placing Respondent on probation for a period of two years from the date the suspension expires. DONE AND ENTERED this 24th day of November, 1998, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON 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 24th day of November, 1998. COPIES FURNISHED: Albert Peacock, Esquire John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A-02 Tallahassee, Florida 32399-1703 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast Bin A-02 Tallahassee, Florida 32399-1703 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact CON APPLICATIONS HCR-CON No.7530 HCR is a publicly owned, for-profit corporation which operates approximately 25 nursing homes in Florida. HCR filed an application, CON No. 7530, to construct a 98-bed freestanding nursing home. HCR proposes to locate the nursing home in the northwest part of Orange County, Florida. HCR proposes that the entire 98-bed facility will be dedicated to the care of patients with Alzheimer's Disease and related dementias. The total cost of the HCR project is $7,132,000 for 47,750 square feet, or $472,776 per bed. The HCR proposal is modeled after an HCR 120-bed nursing home facility in Boynton Beach, Florida. The Boynton Beach facility is entirely dedicated to the treatment of patients with Alzheimer's Disease or related dementias. The proposed HCR facility in Orange County would be identical to the Boynton Beach facility less one patient wing. HCR's Boynton Beach facility, as well as HCR's existing Orange County nursing home facility, have superior licensure ratings. HCR's Boynton Beach facility received accreditation with commendation from the Joint Commission on the Accreditation of Health Care Organizations (JCAHCO), a national accreditation body which has established standards to measure the quality of care in dementia care units. Dementia is a complex of symptoms that can be caused by many different underlying diseases. Alzheimer's disease is one cause of dementia. Alzheimer's disease is the most common cause of dementia. Significant research is being conducted into the cause and treatment of Alzheimer's disease. Dementia is defined as a decline in intellectual function; global cognitive impairment, that is memory impairment and at least one of the following: impairment of abstract thinking; impairment of judgment; impairment of other complex capabilities such as language use, ability to perform complex physical tasks, ability to recognize objects or people, or to construct objects; and, personality change. The Reisberg Cognitive Rating Scale (RCS) classifies the stages of Alzheimer's disease from 1 to 7, with a rating of 7 being most severe. The rating scale is based on 10 axes: concentration, recent memory, past memory, orientation, functioning and self-care, speech, motor functioning, mood and behavior, practice of an art or skill, and calculation ability. The Global Deterioration Scale (GDS) for Age-Associated Cognitive decline and Alzheimer's Disease also defines seven stages of deterioration ranging from no cognitive decline to very severe cognitive decline. Persons suffering from Alzheimer's disease generally cannot survive without assistance upon reaching early dementia or level five on both the RCS and GDS. Approximately 50-58 percent of persons currently residing in community nursing homes suffer from some form of dementia. There is a need for community nursing home beds for persons suffering from the latter stages (levels 5-7) of Alzheimer's disease in Orange County. It is particularly difficult to place in nursing homes in Orange County, persons suffering from the latter stages of Alzheimer's disease (levels 5-7) who also have displayed a history of disruptive behavior patterns. Persons suffering from the latter stages of Alzheimer's disease have specific needs for care and treatment in nursing homes. Alzheimer's victims tend to wander and should have areas set aside for secured walking. The movement of Alzheimer's victims should also be carefully monitored. HCR's Boynton Beach facility, which is the prototype for HCR's proposed Orange County facility, has specific design features to accommodate the needs of patients suffering from the latter stages (levels 5-7) of Alzheimer's disease. HCR proposes a pod design of five residential pod units each with a central living area, also called the atrium area. The resident rooms open to the central living area. Each pod has an enclosed courtyard. Access to the courtyards is controlled. The two nursing stations are centrally located in each wing of the facility. Each central living area, or atrium, is visible from one or the other of the nursing stations. HCR provides specific staff training in the care and treatment of Alzheimer's disease and related dementias. A unit or a facility dedicated to the treatment of dementia patients may reduce the need for psychotropic medication of the patients. On a long-term basis, there may be some staff burnout in a facility or unit dedicated solely to the care and treatment of victims of Alzheimer's disease or related dementias. HCR proposes that its CON be conditioned upon locating in northwest Orange County, providing at least 30 percent of its patient days to Medicaid eligible persons, providing respite care, and dedicating all 98 beds to the care and treatment of persons suffering from Alzheimer's disease and related dementias. HCR currently meets its Medicaid commitment in the Boynton Beach facility. LIFE CARE CON Nos. 7534 and 7534P LIFE CARE is a for-profit corporation which owns and operates two nursing homes in Florida. LIFE CARE also operates three other nursing homes in Florida. As of September 1993, LIFE CARE had a net worth of approximately $50 million. LIFE CARE proposes to construct a freestanding 98-bed nursing home (CON No. 7534) in southwest Orange County, at a total cost of $5,988,000. The LIFE CARE 98-bed facility proposal includes a 20-bed unit dedicated to the care and treatment of persons suffering from Alzheimer's disease, a 20-bed subacute unit, an adult day care center, mental health services, and services to persons suffering from AIDS/HIV. LIFE CARE also made a partial request (CON No. 7534P) for a 60-bed facility which would be constructed at the same site and would include the same features. For economic reasons, patients are being released from acute care hospital settings at earlier stages of recovery and there is a need for subacute nursing home services in Orange County. The incidence of AIDS/HIV is increasing and there is a need for nursing home services for persons suffering from AIDS/HIV in Orange County. The 20-bed unit proposed by LIFE CARE for the care and treatment of Alzheimer's patients will be a distinct part of the facility, separate from other residents. The Alzheimer's unit has its own dining area and activity area, a centrally located bathing facility, and a secured courtyard for wandering space. The 20-bed LIFE CARE subacute unit will also be separate. The subacute unit will have two ventilator areas and be contiguous to a therapy area. The LIFE CARE design includes outdoor courtyards, a library, gift shop, and ice cream parlor. Pursuant to Sections 408.037(2)(a) and (b), Florida Statutes, one of the required elements of a CON application is the listing of capital projects, which is presented in Schedule 2 of the CON application. The Schedule 2 filed by LIFE CARE in these proceedings is identical to the Schedule 2 filed by LIFE CARE in the December 1993 batching cycle for LIFE CARE'S proposed Clay County Project, CON No. 7501. It has been held that Schedule 2 of the LIFE CARE Clay County Project CON application No. 7501 met minimum CON application content requirements. Life Care Centers of America, Inc. v. State of Florida, Agency for Health Care Administration, 20 F.L.W. 1435 (Fla. 1st DCA June 12, 1995). During November of 1993, a LIFE CARE nursing home located in Altamonte Springs was downgraded from a superior to a conditional licensure rating due to a deficiency related to outdated medication. The conditional rating given to the facility was in effect for approximately fifty days. The facility was then given a standard rating, and upon the annual survey in the fall of 1994, the facility has been recommended for a superior rating. All other LIFE CARE facilities have superior ratings. LIFE CARE proposes to condition its CON application upon providing Medicaid participation of 65 percent in the 98-bed facility, and 43 percent in the 60-bed facility. ADVENTIST CON No. 7528 ADVENTIST is a not-for-profit corporation that owns and operates nursing homes, hospitals, and other health care related enterprises. ADVENTIST is a wholly owned subsidiary of Adventist Health System/Sunbelt Health Care Corporation, which owns and operates hospitals and health care facilities throughout the United States. ADVENTIST has operated health care facilities in Orange County since the early 1900s when Florida Hospital was founded. ADVENTIST is the largest hospital system in Orange County, with more than 1,400 beds located on five campuses. ADVENTIST proposes to add 38 beds to an existing freestanding 80-bed community nursing home, Sunbelt Living Center-East Orlando (SLC), which is directly adjacent to Florida Hospital's East Orlando campus. The ADVENTIST proposal would include a 20-bed subacute unit and also an 18-bed skilled nursing unit. This addition to SLC would be accomplished by constructing two new wings to the existing facility. The projected cost of the ADVENTIST addition is $1,386,500, or approximately $36,000 per bed. SLC is an 80-bed skilled nursing facility which opened in January of 1993. SLC has a superior licensure rating. SLC provides nursing home service to a variety of residents, including persons with AIDS/HIV, as well as persons with a primary diagnosis of Alzheimer's disease and related dementia. SLC does not have a distinct Alzheimer's unit, but is equipped with security features to accommodate Alzheimer's patients. SLC staff is trained in the care and treatment of all its residents, including those with dementia. SLC reached an occupancy rate of 96 percent-97 percent capacity in its first ten months of operation. The SLC design is based on a residential model. The intent of the design is to create a residential community, and to encourage the interaction among the residents, and also between the residents and staff. The residential wings contain twelve rooms with private and semiprivate accommodations. Each room has its own toilet facilities. The support facilities, food service, therapy areas, administrative offices, visitor and welcoming areas, are located in the center of the facility. The residential wings are clustered on each side of the facility. The facility also features outdoor courtyards and walkways adjacent to the residential wings. ADVENTIST proposes to condition its CON application on providing a Medicaid commitment of 65 percent of total patient days in the non-subacute wing of the 38-bed expansion. The ADVENTIST proposal also features an AIDS program and respite care. ADVENTIST currently meets it Medicaid commitment at SLC. As indicated above, there is a need for subacute nursing home beds in Orange County. There is a need for nursing home beds for persons suffering from AIDS/HIV in Orange County. In the 20-bed subacute unit ADVENTIST proposes that each room will include wall-mounted suction and gases to accommodate ventilator dependent patients, which will enable ADVENTIST to provide more intensive subacute care. RHA/PRINCETON CON No.7538 RHA is the owner and operator of Princeton Hospital, located on the west side of Orlando. Princeton Hospital is situated on 32 acres bordering Lake Lawne. Princeton Hospital has 150 beds, including 24 psychiatric beds, a multipurpose intensive care unit, a 13-bed progressive care unit, a nursery, pediatric services, women's services, an obstetrical unit and an inpatient cardiac catheterization lab. The psychiatric unit at Princeton Hospital treats a wide range of mental disorders, including those afflicting the elderly population. The hospital also operates a senior psychiatric partial hospitalization program which serves geriatric patients, including persons suffering from Alzheimer's disease and related dementias. Princeton Hospital currently provides care and treatment to persons suffering from AIDS/HIV. Princeton Hospital is accredited by the Joint Commission on Accreditation of Health Care Organizations. On August 1, 1994, subsequent to the filing of CON application No. 7538, Princeton Hospital entered into a wide-ranging affiliation agreement with the University of Florida, College of Medicine and Shands Hospital. The agreement provides for extensive reciprocal training and educational programs between Princeton Hospital and the College of Medicine, as well as Shands Hospital. The agreement also provides for priority transfer of patients between Princeton and Shands hospitals. RHA proposes to include its nursing home facility within the scope of the affiliation agreement. The nursing home staff would benefit from the training and educational opportunities, and the nursing home patients would have access to priority reciprocity with the College of Medicine and Shands Hospital as provided for in the agreement. During fiscal years 1993 and 1994 Princeton Hospital had a Medicaid patient ratio of approximately 40 percent. Princeton Hospital also provides indigent care. RHA proposes to construct a freestanding 60-bed Medicaid certified skilled nursing facility on the campus of Princeton Hospital at a cost of $4,991,961 for 43,741 square feet, or $83,199 per bed. The services that are proposed include subacute care, a 15-bed unit for persons suffering from Alzheimer's disease and related dementias, long term care, and two pediatric beds. Respite care will also be provided. RHA proposes that its subacute care unit would provide step-down care for patients referred from acute care hospital settings. RHA also proposes to provide rehabilitative therapies to serve patients suffering from fractured hips and joint replacements as well as other patients needing more intensive physical therapy. Cardiac and respiratory patients will also be served in the subacute unit. As indicated above, there is a need for subacute nursing home beds in Orange County. RHA's proposed 15-bed Alzheimer's unit will be a distinct and secured part of the facility. The unit will have its own enclosed courtyard and activities area. As indicated above, there is a need for nursing home beds for persons suffering from Alzheimer's disease and related dementias in Orange County. RHA also proposes a program dedicated to the care and treatment of persons suffering from AIDS/HIV. This program will provide long-term care, and will include psychiatric, as well as subacute services. As indicated above, there is a need for nursing home beds for persons suffering from AIDS/HIV in Orange County. The RHA proposal includes two pediatric nursing home beds. It is not uncommon to provide pediatric nursing home beds in a small unit within a nursing home facility. These beds will provide subacute care to pediatric patients referred from acute care hospital settings. It is anticipated that the pediatric unit will serve patients with respiratory problems and other multiple system failures. RHA has experienced difficulty in placing pediatric patients discharged from Princeton Hospital. The RHA facility is designed in a series of modules. There are four patient wings located around a single nursing station. The Alzheimer's wing is distinct and secured. The pediatric beds are located in a single semiprivate room close to the nursing station. The subacute unit includes six beds with wall-mounted medical gases and vacuums. Each residential room has approximately 272 net square feet, and features its own handicapped toilet and bathing facilities. The facility includes a chapel, convenience store, laundry, ice cream shop, and beauty shop, designed in a mall concept. The corridors are ten feet in width instead of the standard eight feet. The intent of the design concept is to encourage social interaction. As designed, the location of the soiled utility room in the facility does not comply with applicable Florida code regulations; however, a proposed minor change in the design will move the soiled utility room approximately twenty feet to bring the facility into compliance with Florida code regulations. ALLOCATION FACTORS Relationship to District and State Health Plans Section 408.035(1)(a), Florida Statutes District Health Plan Allocation Factor 1 of the District Health Plan provides a priority for an applicant proposing to locate in the northwest Orange County population center. This preference will continue to be given applicants until a total of 120 beds is obtained. HCR is the only applicant proposing to locate in the northwest Orange County population center; however, in January of 1993, Sunbelt Living Center, a 120-bed community nursing home opened in Apopka, Florida, which is located in the northwest Orange County population center. Accordingly, the total bed number for this preference has been obtained, and this district allocation factor is inapplicable to these proceedings. Allocation Factor 2 of the District Health Plan provides a preference for applicants developing specific services for newborn and/or pediatric patients. RHA is the only applicant proposing specific services which include a unit for the care and treatment of pediatric patients. Accordingly, RHA is the only applicant which meets this allocation factor. Allocation Factor 3 of the District Health Plan provides a preference for an applicant proposing to develop a specific specialty service (or services), such as a unit for medically complex patients, a unit dealing with psychiatric disorders as a primary diagnosis, or services for persons suffering from AIDS/HIV. This preference is also provided to an applicant which commits to working with, or in conjunction with, an existing provider of a specialty service, such as hospices, or mental health providers. RHA is the applicant which best meets this allocation factor. The RHA proposal provides for specialty services for medically complex patients, provides for services to persons suffering from AIDS/HIV, and RHA specifically commits to working with mental health providers, including working with the psychiatric unit at Princeton Hospital. ADVENTIST and LIFE CARE also propose to provide specialty services to medically complex patients in subacute units; however, the ADVENTIST facility is better equipped in this regard and is designed with piped in medical gases, vacuum, and expanded electrical capacity will have the capability to provide more extensive services. LIFE CARE also proposes to treat persons suffering from AIDS/HIV and persons with mental disorders. The LIFE CARE proposal, however, is not as specific in this regard as that of RHA. HCR proposes to provide specialty services to persons suffering from Alzheimer's disease and related dementias, and is in general compliance with this allocation factor. State Health Plan Allocation Factors Each applicant meets the first State Health Plan allocation factor which provides a preference for an applicant proposing to locate in areas within the subdistrict with occupancy rates exceeding 90 percent. The occupancy rate in Orange County exceeds 90 percent. RHA and LIFE CARE meet the second State Health Plan allocation factor which provides a preference for an applicant proposing to serve Medicaid patients in proportion to the average subdistrict-wide percentage of nursing homes. In Orange County the average is 65 percent for Medicaid service. ADVENTIST meets this preference with regard to its non-subacute unit. HCR which proposes a 30 percent Medicaid service does not meet this preference. The third State Health Plan allocation factor provides a preference to an applicant proposing specialized services to special care residents, including AIDS residents, Alzheimer's residents, and the mentally ill. Each applicant generally complies with this allocation factor and offers specialty services; however, RHA with its broader spectrum of specialty services, including services to AIDS/HIV residents, Alzheimer's residents, and its specific commitment to working with residents suffering from psychiatric disorders best meets this preference. The fourth State Health Plan allocation factor provides a preference to an applicant proposing to provide a continuum of services to community residents including, but not limited to, respite care and adult day care. RHA and ADVENTIST best meet this preference. RHA and ADVENTIST have a history of providing quality health care service to the community. RHA and ADVENTIST have extensive ongoing relationships with acute care hospitals. HCR and LIFE CARE have also established relationships which will address providing a continuum of care, but not to the extent proposed by RHA and ADVENTIST. The fifth State Health Plan allocation factor provides a preference to an applicant proposing to construct facilities which provide maximum resident comfort and quality of care. Each applicant proposes facilities designed to provide resident comfort and quality care. Each design has comfortable resident rooms, spacious activities areas, recreation areas, courtyards, landscaping, therapy rooms, and staff lounge areas. Each applicant meets this preference. The sixth State Health Plan allocation factor provides a preference for an applicant proposing innovative therapeutic programs which have proven effective in enhancing the residents' physical and mental functioning level and which emphasize restorative care. Each of the applicants' proposals feature specific elements of innovative therapeutic programs. HCR has received an award for its innovative design of the Boynton Beach Alzheimer's unit. RHA offers a multi-discipline approach with a psychiatric program. ADVENTIST offers an intensive subacute care unit, and LIFE CARE offer a well-balanced approach with intensive staff training. The seventh State Health Plan allocation factor provides a preference for an applicant proposing charges which do not exceed the highest Medicaid per diem rate in the subdistrict. In this respect, HCR projects Medicaid charges of $96.20 per patient day in Year 1, and $93.32 in Year 2. LIFE CARE projects Medicaid charges of $104.74 per patient day in Year 1, and $106.20 in Year 2. ADVENTIST projects Medicaid charges of $106.00 per patient day in Year 1, and $111.30 in Year 2. RHA projects Medicaid charges of $107.02 per patient day in Year 1, and $109.24 in Year 2. While HCR projects the lowest Medicaid per diem charges and appears to best meet this allocation factor, all applicants have agreed to a specified Medicaid utilization rate, and will accept the appropriate Medicaid reimbursement levels. The eighth State Health Plan allocation factor provides a preference for an applicant with a history of providing superior resident care in Florida or other states. HCR has maintained superior licensure ratings, and its prototype Boynton Beach facility currently is rated superior. LIFE CARE in 1993 experienced a conditional rating for its Altamonte Springs facility; however, the facility, upon evaluation in the fall of 1994, is now recommended for a superior licensure rating. RHA does not currently operate nursing homes; however, RHA has a history of providing quality care in its Princeton Hospital. ADVENTIST is the only applicant proposing to add nursing home beds to an existing facility that currently has a superior licensure rating, and in this respect, ADVENTIST best meets this allocation factor. The ninth State Health Plan allocation factor provides a preference to an applicant proposing staff levels which exceed minimum staffing standards contained in licensure administrative rules. Applicants proposing higher ratios of RNs- and LPNs-to-residents shall be given preference. All applicants meet this factor; however a comparison of the nursing staffing patterns of the applicants reflects that HCR (45.40 nursing FTE) and LIFE CARE (45.30 nursing FTE) have a higher than the minimum required ratio of nursing staff to residents for their proposed 98-bed facilities. RHA has proposed 35.30 nursing FTE for its 60-bed facility. ADVENTIST proposes a total 62.40 nursing FTE for its facility after the proposed 38-bed addition. The tenth State Health Plan allocation factor provides a preference for an applicant who will use professionals from a variety of disciplines to meet the residents' needs for social services, specialized therapies, nutrition, recreational activities, and spiritual guidance. These professionals shall include physical therapists, mental health nurses, and social workers. All the applicants offer a wide range of social, spiritual, nutritional, and recreational services. RHA, however, also proposes specific utilization of mental health care professionals, and a specific affiliation with the psychiatric care professionals from Princeton Hospital, and best meets this factor. The eleventh State Health Plan allocation factor provides a preference for an applicant who ensures the residents' rights and privacy, and who implements a well-designed quality assurance and discharge planning program. Each applicant has documented specific plans for quality assurance and ensuring the residents' rights and privacy are protected. Accordingly, each applicant meets this factor. The final State Health Plan allocation factor provides for a preference to an applicant proposing lower administrative costs, and higher resident care costs compared to the average nursing home in the district. HCR has the lowest projected administrative and overhead costs ($18.28 per patient day as of Year 2), and best meets this allocation factor. Statutory Review Criteria, Section 408.035(1), F.S. Section 408.035(1)(b): The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, inadequacy of like and existing health care services and hospices in the service district of the applicant. HCR, LIFE CARE, and RHA each proposes a unit dedicated to the care and treatment of persons suffering from Alzheimer's disease and related dementias (HCR 98-bed facility, LIFE CARE 20-bed unit, and RHA 15-bed unit). ADVENTIST, while currently providing care for Alzheimer's patients at SLC, does not propose a distinct Alzheimer's unit in its 38-bed addition. There are currently at least five nursing homes in the service district, and two others in close proximity, which feature dedicated Alzheimer's units, with a total of at least 345 nursing home beds serving Alzheimer's patients. There is a high utilization rate of Alzheimer's nursing home beds in the district. While there is an established need for more beds to serve Alzheimer's patients, particularly Alzheimer's patients with a history of disruptive behavior, there are additional needs in the service district to provide care and treatment for subacute patients, and for persons suffering from AIDS/HIV. It is difficult to quantify the need for subacute nursing home beds due to the differing professional definitions of what constitutes subacute care; however, acute care hospitals in Orange County are, for cost-effective reasons, now releasing patients on an earlier basis, and there is an established need for nursing home beds to accommodate persons released from acute care hospitals. There is a high utilization rate of subacute beds in the district. There has also been an increase in the incidence of AIDS/HIV patients, and in the need for nursing home beds for persons suffering from AIDS/HIV in the service district. Section 408.035(1)(c): The ability of the applicant to provide quality of care and the applicant's record of providing quality of care. Each applicant has the ability to provide quality of care, and each applicant has a history of providing quality of care. The distinguishing factors in this regard are that LIFE CARE is the only applicant that has experienced a downgrading of a nursing home facility from a superior to a conditional licensure rating, and ADVENTIST is the only applicant that proposes to add nursing home beds to a facility that currently has a superior licensure rating. In comparison, ADVENTIST best meets this factor, and LIFE CARE least meets this factor. Section 408.035(1)(e): Probable economies and improvements in service that may be derived from operation of joint, cooperative, or shared health care resources. ADVENTIST and RHA both have specific proposals to work with, and share services with acute care hospitals. Both are in close proximity to acute care hospitals which will expedite sharing of medical resources. RHA will also share dietary services with Princeton Hospital. The freestanding facilities proposed by HCR and LIFE CARE do not have this advantage. Section 408.035(1)(f): The need in the service district for special equipment and services which are not reasonably and economically accessible in adjoining areas. This factor is inapplicable to the proposals. No specific need was established as to special services and equipment not reasonably and economically accessible in adjoining areas. There are dedicated Alzheimer's units and dementia services for persons in adjoining areas. Section 408.035(1)(g): The need for research and educational facilities, including but not limited to, institutional training programs and community training programs for health care practitioners. RHA has an extensive proposal for the participation and training of health care practitioners in conjunction with Princeton Hospital and best meets this criterion. RHA's affiliation with the University of Florida College of Medicine, Shands Hospital, and the Brain Institute at the University of Florida enhances this proposal. ADVENTIST shares a similar educational and training relationship with Florida Hospital, and with Florida Hospital's registered nurse baccalaureate degree program through Southern College. LIFE CARE proposes to establish relationships with local community colleges and education centers to sponsor nursing programs. Section 408.035(1)(h): The availability of resources, including health manpower, management personnel, and funds for capital and operating expenditures for project accomplishment As stipulated, each applicant meets this criterion. Each applicant also has substantial personnel and management resources available for project accomplishment. Section 408.035(1)(i): The immediate and long- term financial feasibility of the proposal. LIFE CARE, ADVENTIST and RHA meet this criterion, and reasonably project positive cash flows by the second year of operation. RHA a not-for- profit corporation, projects a net loss of $114,000 in Year 1 of operation, and an excess of revenues over expenses of $53,000 in Year 2 of operation. LIFE CARE projects a net loss of $440,496 in Year 1 and a net gain of $145,085 in Year 2 for the 98-bed facility, and a net loss of $259,971 in Year 1 and a net gain of $54,920 in Year 2 for the 60-bed facility. HCR projects an after-tax profit of $25,000 in Year 2; however, in order to attain a level of profitability HCR must meet its projected 65 percent private pay utilization. This is a very high private payor mix, and there is a significant question as to whether this payor mix is attainable in the subdistrict; however, as proposed, HCR meets this factor. Sections 408.035(1)(k)(l) and (m): Impact of the project on cost of health services; cost effective- ness; construction costs. ADVENTIST proposes the most cost-effective project by adding beds to an existing facility (SLC). The addition of 38 beds to SLC will promote and maximize the overall efficiency of the facility which was originally designed with core support features to accommodate 120 residents. The proposed 38-bed addition to SLC will also lower the costs per patient day of the entire facility. The ADVENTIST proposal adds nursing home beds at the lowest per bed cost ($36,000 per bed) of all applicants. Similarly, RHA is located on the campus of an existing acute care hospital owned by the applicant and, unlike HCR and LIFE CARE, projects no actual cash expenditure for land acquisition. Each applicant has proposed a reasonable design of its proposed facility and reasonable construction costs, and taken into consideration applicable costs and methods of energy provision and conservation. Each applicant meets this criterion. Each applicant has also proposed a very high quality of care facility that will foster competition and promote quality assurance and cost- effectiveness. Each applicant meets this criterion. Section 408.035(1)(n): The applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent. RHA, ADVENTIST and LIFE CARE have proposed providing health care services to Medicaid patients at rates at, or in excess of, the district average. HCR proposes the lowest Medicaid service rate at 30 percent. RHA also has a strong record of providing Medicaid services and service to the medically indigent at Princeton Hospital. All applicants except HCR meet this factor. Section 408.035(1)(o): The applicant's past and proposed provision of services which promote a continuum of care in a multilevel health care system. The RHA and ADVENTIST proposals best meet this criterion. Both the RHA and the ADVENTIST proposals are closely associated with existing hospitals, and emphasize a continuum of care from the acute hospital setting to a nursing home facility. The RHA and ADVENTIST proposals promote the interaction of health care professionals in a multilevel health care system. The HCR and LIFE CARE proposals do not reflect such an extensive interconnection with other aspects of the health care system, and do not promote a continuum of care to the extent proposed by RHA and ADVENTIST. Section 408.035(2)(b): Whether existing inpatient facilities providing inpatient services similar to those being proposed are being used in an appropriate and efficient manner. The evidence reflects that the existing inpatient facilities in, or adjacent to, the district which offer subacute and AIDS services, as well as services dedicated to the care and treatment of persons suffering from Alzheimer's disease and related dementias are operating at, or near, capacity, and are being used in an appropriate and efficient manner.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: RHA's application for CON No. 7538 be APPROVED. ADVENTIST'S application for CON No. 7528 be APPROVED. HCR's application for CON No. 7530 be DENIED. LIFE CARE'S applications for CON Nos. 7534 and 7534P be DENIED. RECOMMENDED in Tallahassee, Leon County, Florida, this 27th day of July, 1995. RICHARD HIXSON 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 27th day of July, 1995. APPENDIX HCR's Proposed Findings 1-5. Accepted in substance. 6. Rejected, insofar as quantification of need for subacute services, while not readily ascertainable, was demonstrated by other applicants.demonstrated need existed in district 7-8. Accepted in substance. 9. See Number 6. 10-14. Accepted in substance, but disposed of by ruling in Clay County case. 15-27. Accepted in substance. 28-36. Rejected insofar as quantification of need for subacute services is not readily accessible; however, need for such services was established. Accepted, except that need for 120 beds has been met. Accepted, except that RHA proposes specific pediatric services and is entitled to preference. Accepted in substance, except last sentence is rejected. Accepted. Accepted, except that ADVENTIST meets preference as to the non- subacute unit. 42-43. Accepted in substance. 44-45. Rejected. Accepted in substance. Accepted, except that ADVENTIST and RHA also meet this factor, and ADVENTIST is adding beds to an existing superior-rated facility. 48-50. Accepted in part, other applicants meet these factors. 51-65. Accepted in substance; however other services are also needed in the district. 66-67. Rejected. 68-73. Accepted in substance. 74-76. Accepted; however other services are also needed in the district. 77. Rejected. 78-86. Accepted in substance. 87-94. Accepted only to the extent that the HCR proposal meets the minimum requirements to demonstrate financial feasibility. 95-103. Accepted in substance; however each applicant's proposal also meets this factor. 104-112. Accepted in substance. 113. Rejected. 114. Accepted; however RHA proposes a minor change to correct this design. 115-116. Accepted only as to RHA design features. 117-122. Rejected. 123-127. Accepted in substance. 128-131. Rejected. LIFE CARE's Proposed Findings 1-3. Accepted in substance. 4. Accepted, except that district plan includes consideration of pediatric population. 5-7. Accepted; however other applicants also meet these factors. See Finding No. 4. Rejected to the extent that it is not uncommon for pediatric care to be provided in a nursing home setting. 10-38. Accepted in substance. 39-40. Rejected to the extent that RHA and ADVENTIST have competitive staff salaries and have experienced no difficulty in hiring qualified staff. 41-57. Accepted in substance. 58-59. Rejected. Accepted; however RHA proposes a minor change to correct this design. Rejected. 62-65. Accepted in substance. 66-69. Disposed of by Clay County case. Accepted; however ADVENTIST meets this factor in the non-subacute unit. Accepted in substance. ADVENTIST's Proposed Findings 1-4. Accepted in substance. 5. Accepted only to the extent that HCR does not propose a specific subacute care unit. 6-13. Accepted in substance. Rejected to the extent that HCR's proposal meets minimum financial feasibility requirements. Accepted. 16-17. Rejected. Accepted. Accepted to the extent that RHA and ADVENTIST best meet this criterion. 20-21. Accepted in substance. 22-26. Disposed of by Clay County case. 27-29. Accepted in substance 30-31. Rejected. 32-35. Accepted in substance. 36. Rejected; see No. 19. 37-106. Accepted in substance. 107. Accepted; see No. 19. RHA's Proposed Findings 1-21. Accepted in substance. 22. Accepted; however other applicants also meet these factors. 23-54. Accepted in substance. 55. Accepted to the extent that there are at least seven nursing homes with dedicated Alzheimer's units in or near the service area. 56-92. Accepted in substance. 93-96. Accepted; however HCR meets minimum financial feasibility requirements. 97-102. Accepted; however LIFE CARE meets minimum financial feasibility requirements. 103. Rejected. 104-122. Accepted in substance. 123. Rejected. 124-135. Accepted in substance. 136. Rejected to the extent that all applicants have met the design criterion. 137-140. Accepted in substance. 141. Rejected. 142-145. Accepted in substance. 146. Accepted to the extent that RHA and ADVENTIST best meet this criterion. COPIES FURNISHED: Stephen K. Boone, Esquire BOONE, BOONE & BOONE, P.A. Post Office Box 1596 Venice, Florida 34284 Alfred W. Clark, Esquire 117 South Gadsden, Suite 201 Tallahassee, Florida. 32301 R. Bruce McKibben, Jr., Esquire PENNINGTON & HABEN, P.A. 215 South Monroe Street, 2nd Floor Post Office Box 10095 Tallahassee, Florida 32301 Michael J. Glazer, Esquire MACFARLANE, AUSLEY, FERGUSON & MCMULLEN, P.A. Post Office Box 391 Tallahassee, Florida 32301 Samuel Dean Bunton, Esquire Senior Attorney, AHCA Atrium Building, Suite 301 325 John Knox Road Tallahassee, Florida 32303-4131 Steven R. Bechtel, Esquire MATEER, HARBERT & BATES, P.A. Post Office Box 2854 Orlando, Florida 32802 James M. Barclay, Esquire COBB, C0LE & BELL 131 North Gadsden Street Tallahassee, Florida 32301
