The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0025685. For 18 years prior to the event complained of herein, Respondent worked at Indian River Memorial Hospital, where he practiced as an anaesthesiologist. Also prior to the event complained of herein, Respondent was a tri- athlete, training in swimming, biking, and running. During the summer of 1992 he competed in five or six tri-athalons and did quite well in his age class. Respondent was also a snow skier. In accordance with his physical fitness values, Respondent does not drink alcoholic beverages or smoke cigarettes. He is also a vegetarian. Peter G. Wernicke is an orthopedic surgeon in the Vero Beach area. After arriving there, he and Respondent became social friends and went on ski trips together. He also became Respondent's treating physician, caring for Respondent when Respondent suffered broken bones, strains, and sprains as a result of his sporting activities. In early winter of 1992 Respondent seriously injured his knee while snow skiing. Respondent discussed his need for surgery with Wernicke after Respondent returned to the Vero Beach area. Wernicke was insistent that he perform Respondent's knee surgery, but Respondent wanted to have the surgery performed by Dr. Richard Steadman in Vail, Colorado, since he believed that Dr. Steadman was probably the best in the world at taking care of that particular kind of knee injury. Wernicke then insisted that Respondent allow Wernicke to perform the knee surgery with Respondent awake, and once the knee was opened up, Wernicke and Respondent would look at it and decide whether it was something Wernicke was able to take care of or if the knee should be closed and Respondent would then go to whomever he wanted to have the surgery performed. Respondent would not agree to that approach since he well understood that opening the knee twice would double Respondent's risk of infection in that injured knee. Up to the time that Respondent left to travel to Vail for his knee surgery, Wernicke maintained that he was not giving Respondent his blessing for having the surgery performed by someone else. Respondent went to Vail and had Dr. Steadman perform the surgery in early December of 1992. Respondent remained in Vail post-operatively undergoing physical therapy which commenced within hours of surgery being completed to increase his chances of obtaining full range of motion with that knee by keeping it moving and preventing scarring. Respondent returned to Vero Beach on December 13 and returned to work the next morning, working a full shift that day. After his shift was over, he drove himself to Orlando for a meeting. While in Orlando, Respondent began to have very severe pain and swelling in his knee. He drove back to Vero Beach, arriving at his home at approximately 9:30 p.m. Upon his arrival, he telephoned Wernicke, told Wernicke he was in a great deal of pain, and begged Wernicke to help him by meeting him at the hospital and looking at Respondent's knee. Wernicke told Respondent that he would not go to the hospital to meet Respondent, that Respondent should elevate his knee and apply ice, and then see Wernicke in the morning. Respondent elevated his leg and applied ice for the next few hours. By approximately midnight the pain had become "absolutely excruciating," unlike any Respondent had experienced with all of his broken bones and other sports injuries. Although Respondent's tolerance for pain was high enough that he had gone through the surgery performed by Dr. Steadman without pain pills and had tolerated getting on an exercise bike 12 hours after that surgery, Respondent knew that he could no longer endure the pain, that he had a serious problem with his post-operative knee, and that he needed to get help immediately. Respondent got himself up with crutches and got in the car to drive himself to the emergency room. While driving, he telephoned the emergency room at Indian River Memorial Hospital and told the staff he was on his way there and asked the name of the orthopedist who was on call. He was advised that Dr. Wernicke was not only on call, but was present in the emergency room at that moment. Respondent told the emergency room staff to tell Wernicke to wait for him. Respondent then called the operating room at Indian River Memorial Hospital and asked if an anaesthesiologist were there so he could get something to relieve his pain. He was told that Dr. Brennan had just finished with surgery and had taken the patient to the intensive care unit. Respondent then asked for two things: (1) to have Dr. Brennan go to the emergency room to take care of Respondent and (2) to bring Respondent's anaesthesia cart to the emergency room. The operating room staff agreed. Respondent's requests resulted from his experience with that hospital's emergency room staff and procedures. He knew he needed medication for his knee and for his pain. He knew that Dr. Brennan was not employed by the hospital and did not have his own anaesthesia cart there. He knew that the emergency room staff were notoriously slow in responding to patient needs or doctor requests. Therefore, over the years, Respondent had learned that whenever he was called to the emergency room, the patient was better served if Respondent took his own anaesthesia cart and supplies with him. As a result of his telephoning ahead, Respondent's arrival was expected. Dr. Wernicke waited for him. Someone took Respondent's anaesthesia cart to the emergency room and placed it next to a stretcher. Dr. Brennan was paged and told that Respondent needed him in the emergency room, and Dr. Brennan went to the emergency room to assist his colleague. When Brennan got there, Respondent had not yet arrived, but Wernicke was present. Brennan told Wernicke he was there to help with Respondent. For whatever reason, Wernicke told Brennan that Brennan was not needed and told him to leave. Before leaving the emergency room, Brennan told Wernicke that if he were needed he would be nearby in the intensive care unit and to please summon him. Respondent arrived at the hospital emergency room on crutches. The emergency room was currently under construction and had no dividing walls or partitions so that it was simply one room in which everyone could see everything occurring. There were no patients in the emergency room when Respondent arrived, but there were three or four nurses and the emergency room doctor at the nurses' station. Respondent went to the nurses' station to be admitted. He was told that he should wait in the lobby and he would be called when they were ready to begin the admission process. Respondent refused to do that, told them he was in excruciating pain, and insisted that he be given the emergency room release form and financial responsibility form to sign and be taken to one of the emergency room stretchers. He was given the forms to sign, which he did, and he was then escorted to the stretcher next to his anaesthesia cart. For the remainder of his time in the emergency room, Respondent remained on that stretcher which was no more than 30 feet from the nurses' station. No chart for his emergency room visit was prepared by the hospital personnel. Further, no one took his vital signs; no one took his blood pressure; no one asked what his problem or complaints were which caused his visit; and no one asked whether Respondent had any allergies or had recently eaten. Respondent lay on the stretcher waiting for Wernicke to return to the emergency room for approximately five minutes. When Wernicke came in, he was wearing a big smile. He remarked to Respondent that Wernicke could see that Respondent had a problem with his knee. Wernicke then gave one swipe across Respondent's knee with an alcohol swab and prepared to jab an 18 gauge needle into the knee to aspirate it, i.e., to drain the fluid. Respondent became terrified and told Wernicke to stop. Respondent's terror was caused by two fears. First, it was apparent that his knee was full of blood. He knew that blood outside of its normal confines is an irritant which causes inflammation and he knew that it was also the perfect medium in which bacteria could grow. He also knew that the risk of infection in his knee was substantial because it was a post-operative knee. Infection in such a knee presents a best-case scenario of a damaged knee and a worst-case scenario of rendering him a cripple, requiring a total knee replacement. Yet, Respondent saw that Wernicke intended to stick the needle into Respondent's dirty knee without even using a Betadine preparation to remove bacteria from the skin. Second, Respondent was in "unbelievable" pain from the significant swelling in his knee. The surgical incisions above and below his knee had ruptured from the pressure caused by the swelling. In order for Wernicke to aspirate Respondent's knee, it would be necessary for him to poke his fingers into the swollen knee area in order to locate the right place to stick the needle, and it was impossible for Respondent to hold his leg still for Dr. Wernicke to palpate, let alone insert the needle in the correct location. Respondent told Wernicke that he needed an I.V. started; that he needed Kefzol, an I.V. antibiotic, to prevent infection; that he needed Toradol intravenously for its anti-inflammatory effect; and that he was in very, very severe pain and needed pain medication so he could hold his leg still for Wernicke to aspirate. Although Wernicke recognized that Respondent was in significant, severe pain, he told Respondent he would agree to the antibiotic and he would agree to the anti-inflammatory, but that he didn't think Respondent needed anything for pain. Respondent's anaesthesia cart was not equipped with I.V. fluids. Someone brought an I.V. bag and set-up. Respondent does not know who brought the I.V. and whether it was on Dr. Wernicke's order or ordered by the emergency room doctor, but Respondent did not order the I.V. brought. No one offered to start Respondent's I.V. for him, and Wernicke did not tell Respondent that Dr. Brennan had come to the emergency room, had been sent away by Wernicke but was nearby, and had told Wernicke to summon him if he were needed. Wernicke kept telling Respondent to hurry up because it was late and he wanted to go home. He told Respondent that they needed to get finished because Wernicke was doing Respondent a favor just by being there. Respondent, while still lying on his stretcher, started his own I.V. Wernicke assisted Respondent by handing him tape for the I.V. since Respondent was performing the task with one hand. Respondent then removed his medication box from the bottom of his anaesthesia cart. He took out an ampule of Kefzol, a dry powder. He took a syringe and drew fluid from the I.V. that was running into him and mixed up that dry powder antibiotic by flushing it back and forth. He then gave the antibiotic to himself. He attempted to delay Wernicke from inserting the needle into his knee until after the antibiotic could circulate through his system and get to his knee before any bacteria was introduced, a process which would take approximately six minutes to complete enough circulations. Respondent next prepped his own knee with Betadine solution while Dr. Wernicke continued to stand there by his side, watching him. Respondent then took an ampule of Toradol, a new anti-inflammatory medication, and gave himself 60 milligrams intravenously, while Wernicke stood and watched. Although that anti-inflammatory medication would also serve to reduce Respondent's pain, Toradol is a slow-acting medication in that regard, having a slow onset but thereafter lasting for a number of hours. Respondent then removed from his medication box a 5 cc ampule of Alfenta. That ampule is a 2 1/2 inch object made of glass with its name in blue lettering on the outside, large enough to read. Alfenta is a Schedule II controlled substance and is a narcotic. Alfenta has a fast onset and a fast offset; it works in 30 to 60 seconds, and its effect lasts for approximately 10 minutes. While Dr. Wernicke watched, Respondent filled a needle and gave himself 1 cc of Alfenta which is a very conservative test dose for a man weighing 190 pounds who is in good condition. Respondent then waited a minute or a minute and a half to see what effect it had on his pain level and trembling leg. It had very little effect. Therefore, Respondent injected an additional 1/2 cc and waited. That additional amount was sufficient. Wernicke watched as Respondent gave himself the Alfenta, standing, as he had been, within inches of Respondent. As he injected the medications, Respondent filled out the chart on his anaesthesia cart, noting the medication, the dosage, and that he was the patient. Respondent then laid back on the stretcher, closed his eyes, and then told Wernicke he was ready. Wernicke then palpated Respondent's knee and inserted the needle to aspirate Respondent's knee. The pressure in his knee was so high that it blew the syringe back. Wernicke commented that he had never before seen that happen and had never seen pressure like that. Wernicke withdrew approximately 100 ccs of fluid from Respondent's knee, commenting that he did not think he'd seen one with more volume. Although initially Wernicke had said that he did not agree that Respondent needed any pain medication, Wernicke totally acquiesced in everything Respondent did to assist Wernicke in treating Respondent. Wernicke accepted Respondent's judgment and watched Respondent execute step by step the course of treatment Respondent said was needed to render proper medical treatment. Wernicke totally agreed and acquiesced with the use of Alfenta as much as he did the antibiotic and the anti-inflammatory as evidenced by Wernicke's own conduct. Wernicke never told Respondent to stop doing Wernicke's work for him. Wernicke never told him not to administer the medications. Wernicke never suggested that he or someone else perform the administration. Wernicke could have easily stopped Respondent who was laying on a stretcher but did not. Wernicke knew that Alfenta was a pain killer and a narcotic. He did nothing to stop or prevent Respondent from injecting a medication Respondent needed. Further, Wernicke continued to treat Respondent after the administration of Alfenta by thereafter performing the aspiration. After he completed the aspiration, Wernicke left. Respondent lay on the stretcher for a little while. The nurses and the emergency room doctor remained at the nurses' station, and there were still no other patients in the emergency room. Respondent asked if someone would bring him a wheelchair so he could leave, and he was told that they were too busy. Respondent took his crutches and hobbled out of the emergency room. The next morning Respondent reported to work for his regular shift which began at 7:00 a.m. After Respondent completed the first case on his shift that day, at approximately 10:30 to 11:30 a.m. he called Haynes McDaniel, the hospital's pharmacist, and told him what had happened the night before, what medications Respondent had used, and that he had used the medications on himself. Respondent said he needed to do whatever paperwork the pharmacist wanted and specifically asked the pharmacist to bill him for the medications he had used. McDaniel told Respondent that there was no problem regarding the Kefzol and the Toradol and that he would simply send Respondent a bill for those medications; however, as to the Alfenta, the pharmacist needed a prescription for his records. McDaniel asked Respondent who the attending physician had been, and Respondent told him that Peter Wernicke was the attending doctor. McDaniel told Respondent to get a prescription from Wernicke for the Alfenta so that the hospital record keeping would be proper. Respondent went to Wernicke and asked him for a prescription for the Alfenta that had been used, and Wernicke refused. Respondent then personally went to McDaniel and told him that Wernicke would not write the prescription and told McDaniel why, i.e., that Wernicke was still mad that Respondent had not considered him good enough to do Respondent's surgery. McDaniel asked Respondent who could write the prescription because Respondent needed a prescription from somebody and Respondent could not write the prescription for himself. Respondent told McDaniel that he had asked Dr. Brennan to be there to give him the pain medication, that Dr. Brennan had never showed up, but that Brennan was in the hospital at the time the medication was administered. McDaniel suggested that Respondent see if Brennan would sign a prescription. Respondent went to Brennan's office and told Brennan exactly what had happened. He told Brennan he had given himself 1 1/2 ccs of Alfenta and that Wernicke was the attending physician. He told Brennan that Respondent had self- administered and why, that Wernicke had refused to write the prescription and why, and that Haynes McDaniel had suggested that Brennan could sign the prescription for the hospital's records. Dr. Brennan became upset that he had not been there to help when his colleague needed him, agreed to sign the prescription, and offered Respondent pain pills or anything else Respondent needed for what remained a painful knee and leg. Respondent declined the offer of any additional medication. In good faith and in the course of his professional practice, Dr. Brennan signed a prescription for 1 1/2 ccs of Alfenta for Respondent. Respondent then hand- delivered that prescription to the pharmacist. After receiving the prescription from Respondent, the pharmacist wrote an Unusual Occurrence Report dated December 16, 1992. In January of 1993 the hospital summarily suspended Respondent's privileges, and he has been unable to practice medicine since that time. Respondent's emergency room visit happened on a Monday evening. On the following Thursday, Respondent and Wernicke's partner Dr. Jim Cain were in the doctor's lounge together. Respondent told Cain that his leg really hurt him and was swollen, and Cain offered to look at it. Respondent pulled up his scrub suit and showed Cain his calf which was twice its normal size and "hot". Cain suggested that Respondent get an ultrasound and get some blood thinner since it looked as though Respondent had developed phlebitis, a dangerous condition. Respondent immediately went to the x-ray department and had an ultrasound performed. The ultrasound revealed that Respondent had compartment syndrome in his calf, four days after the aspiration was performed. Dr. Wernicke's office notes regarding Respondent's emergency room visit, supposedly dictated that same evening or the following day, discussed the ultrasound that Respondent had. Accordingly, Dr. Wernicke did not dictate his notes regarding his treatment of Respondent on Monday evening or on Tuesday. Those notes, however, do bear Tuesday's date and are included in the hospital's medical record for Respondent's emergency room visit. The medical chart created by the hospital was likely created on December 21, 1992, the date stated on the Unusual Occurrence Report as the date the chart was initiated. The chart which thereafter purports to be Respondent's emergency room record is actually a composite of different patients' charts. To the extent it purports to be Respondent's chart, the entries contained therein are false. The Alfenta used by Respondent was an appropriate drug for the purpose for which it was used. It is a rapid but short-acting narcotic analgesic when given in the amount in which it was given. Further, the amount of Alfenta administered was an appropriate dose. Respondent used the Alfenta because it was an appropriate drug for immediate relief so he could endure the palpation and aspiration of his knee and so he could stop his leg from trembling allowing Wernicke to aspirate it. He knew the Alfenta would be worn off even before the analgesic effect of the anti- inflammatory medication was felt. It is noteworthy that all physicians who testified in this proceeding rated the pain Respondent was in as between eight and ten on a pain scale where ten is the worst. Respondent did not use Alfenta as a result of any addiction, and his use of the drug under the circumstances in this case was not related to any abuse of narcotics. Respondent has not exhibited any of the behavior of a drug user. Respondent did not engage in any attempt to "cover up" his administration of Alfenta to himself. He called the hospital and requested his anaesthesia cart be brought and that an anaesthesiologist come to the emergency room to administer the medication. The administration occurred with the implicit consent of Wernicke and it took place in front of Wernicke, in front of three or four emergency room nurses, and in front of the emergency room doctor. At the time, he filled out the narcotics record on his anaesthesia cart and telephoned the hospital's pharmacist the following day to tell him what had occurred and request that he be billed for the medication he used. His giving the hospital a prescription from Dr. Brennan was caused by Wernicke's refusal to document the treatment he rendered to Respondent, by Respondent's inability to write his own prescription, and was in response to the hospital's specific request that a prescription be written for the purpose of the hospital's record keeping. Further, Dr. Wernicke knew what had happened, as did the other emergency room personnel present that evening, and Respondent fully disclosed the events that had occurred to both Dr. Brennan and to the hospital pharmacist. Respondent's use of Alfenta on December 14, 1992, was not in any way related to patient care and had no impact on any patient care rendered by Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 28th day of March, 1995, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 2-6 and 9-12 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Petitioner's proposed findings of fact numbered 7, 8, 13, 14, and 16 have been rejected as not being supported by the weight of the competent evidence in this cause. Petitioner's proposed finding of fact numbered 15 has been rejected as being subordinate to the issues herein. Respondent's proposed findings of fact numbered 1, 3-19, 21-31, 33-35, 38-40, 42, 43, and 45 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 2, 20, 32, 36, 37, and 44 have been rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Respondent's proposed finding of fact numbered 41 has been rejected as being subordinate to the issues herein. COPIES FURNISHED: Arthur B. Skafidas, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Joseph L. Mannikko, Esquire 215 South Federal Highway, Suite 100 Stuart, Florida 34994 Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Tom Wallace, Assistant Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue in this case is whether Respondent, Arnaldo Carmouze, P.A., committed violations of Chapter 458, Florida Statutes (2001), alleged in an Administrative Complaint filed with Petitioner on February 25, 2004, in DOH Case Number 2002- 16502, as amended; and, if so, what disciplinary action should be taken against his license to practice as a physician assistant in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians and physician’s assistants licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Arnaldo Carmouze, P.A., is, and was at the times material to this matter, a physician's assistant licensed to practice in Florida, having been issued license number PA 9100713. Mr. Carmouze's address of record at all times relevant to this matter is 6545 Southwest 95th Avenue, Miami, Florida 33173. No evidence that Mr. Carmouze has previously been the subject of a license disciplinary proceeding was offered. Mr. Carmouze's Supervising Physician. At the times relevant Mr. Carmouze worked under the supervision of Dr. Manuel Fernandez-Gonzalez, a physician licensed to practice medicine in Florida. Dr. Fernandez-Gonzalez, who has practiced emergency medicine, holds Florida medical license number ME 17907. Dr. Fernandez-Gonzalez currently practices family medicine at 9600 Southwest 8th Street, Miami, Florida. Prior to April 2002, Dr. Fernandez-Gonzalez and Mr. Carmouze worked together in Miami, providing emergency room care and seeing patients at a nursing home. The emergency room services were provided pursuant to employment contracts that both had entered into with a company providing emergency room services at the hospital in south Florida where Dr. Fernandez- Gonzalez and Mr. Carmouze provided services. Mr. Carmouze's Assignment to Weems Memorial Hospital. The company for which Mr. Carmouze was employed also provided emergency room services for Weems Memorial Hospital (hereinafter referred to as "Weems"). Weems is located in Apalachicola, Florida, located in the Florida Panhandle, approximately 520 miles from Miami. Weems is a rural hospital, licensed under Chapter 395, Florida Statutes. It does not have 24-hour, on-site ancillary services such as X-ray, laboratory, and respiratory therapy. These services are available to the emergency room on an on-call basis after business hours. At the times relevant, Malvinder Ajit, M.D., a Florida licensed physician, was the Director of the Emergency Department at Weems. Dr. Ajit has not provided any documentation to the Department indicating that he has ever acted as supervising physician of record for Mr. Carmouze. Mr. Carmouze was assigned by the company by which he was employed to work in the emergency room at Weems in April 2002 and again in June 2002. He worked in the emergency room at Weems as a physician's assistant for part of April 2002, and part of June 2002. While at Weems, Mr. Carmouze provided emergency room medical services to more than 100 patients. While working at Weems, Dr. Fernandez-Gonzalez, who remained in Miami, continued to act as Mr. Carmouze's supervising physician. Mr. Carmouze did not notify the Department that he was practicing as a physician's assistant at Weems in April or June 2002. The evidence, however, failed to prove that Mr. Carmouze was working for, and thus "employed," by anyone different from the employer that he worked for in Miami. The only evidence on this issue proved that Mr. Carmouze continued throughout the relevant period to work for Dr. Fernandez-Gonzalez and the company that provided emergency room services at Weems. Dr. Carmouze's Treatment of Patient A.M. On June 7, 2002, Patient A.M., an 84-year-old female, was brought to the emergency room (hereinafter referred to as the "ER"), at Weems by ambulance. She arrived at approximately 23:24 hours (11:24 p.m.). A.M.'s medical history included congestive heart failure, coronary artery disease, and atrial fibrillation. She presented to Mr. Carmouze in apparent respiratory distress (respiratory rate of 36 to 40), had no measurable blood pressure, and a pulse rate of 100 to 108. While being transported to the ER from her home, A.M. was given oxygen by rebreather mask. During her transport, her oxygen saturation level improved from 68% to 91%. Mr. Carmouze assessed A.M.'s condition, obtained her medical history, ordered lab work and other tests, and ordered and initiated nebulizer treatments for her. She was alert, oriented and had a Glasgow score of 15/15, indicating she was responding to verbal and pain stimuli. Mr. Carmouze ordered nebulizer treatments with albuterol and atrovent to assist her breathing. Additionally, A.M. received 100% oxygen through a nonrebreather mask. Mr. Carmouze also determined that A.M. was "dry," meaning that her fluid volume was depleted and, therefore, she was dehydrated. As a result, her blood pressure was low. In an effort to treat this condition, Mr. Carmouze ordered an I.V. with 0.9 normal saline. He also ordered a Dopamine drip to increase A.M.'s heart rate in an effort to increase her blood pressure. Mr. Carmouze appropriately denied a request from a nurse to administer Lasix to A.M., because A.M. was "dry." Lasix is a diuretic used to decrease fluid volume. It opens the arteries and reduces fluids, thereby lowering blood pressure. Lasix was contraindicated for A.M. and contrary to the appropriate efforts initiated by Mr. Carmouze to treat A.M.'s low blood pressure. Despite Mr. Carmouze's treatment of A.M., her condition continued to deteriorate. At or near 23:50 hours (11:50 p.m.), approximately 25 minutes after A.M. had arrived at the ER, an ER nurse contacted A.M.'s primary physician by telephone and obtained an order to administer Lasix to A.M. The Lasix was administered immediately. A.M.'s oxygen saturation level was 81%, down 10 points since her arrival, when the Lasix was administered. Within half an hour, at 0:18 hours (18 minutes after midnight) on June 8, 2002, A.M.'s oxygen saturation level had dropped another 10 points, to 71%. A.M. then "crashed and coded." Mr. Carmouze initiated appropriate emergency measures when A.M. coded, including initiating Cardio Pulmonary Recitation and endotracheal intubation. A.M. was given epinephrine, atropine, and a CVP line was placed. These actions by Mr. Carmouze were appropriate. Mr. Carmouze did not attempt or order that A.M. be intubated prior to 0:18 hours when she coded. A.M.'s primary physician, Dr. Sanaullah, arrived at the ER. Shortly after she coded, Dr. Sanaullah continued the same efforts initiated by Mr. Carmouze. A.M., however, did not recover, expiring at 01:00. The "Standard of Care" for Treating A.M. Four expert witnesses testified in this matter, rendering opinions as to whether Mr. Carmouze's treatment of A.M. was consistent with "that level of care, skill, and treatment which is recognized by a reasonably prudent similar [physician assistant] as being acceptable under similar conditions and circumstances. . . " (hereinafter referred to as the "Standard of Care"). The expert witnesses who testified were Dr. Fernandez-Gonzalez, Dr. Julio Lora, Dr. Harry W. Lee, and James L. Cary, P.A. Dr. Fernandez-Gonzalez's testimony as to whether Mr. Carmouze treated A.M. within the Standard of Care is rejected for lack of credibility. Dr. Fernandez-Gonzalez's testimony has been found to lack credibility for the reasons explained by Petitioner in paragraph 25 of Petitioner's Proposed Recommended Order. That paragraph, except for the last two sentences, is hereby adopted. Additionally, Dr. Fernandez- Gonzalez's testimony is rejected because, in the undersigned's judgment, he made too much of an effort to give the answers that he appeared to conclude that Mr. Carmouze wanted him to give. The testimony of Dr. Lora on the other hand is found to be credible. Dr. Lora, testifying as an expert in cardiology and internal medicine, offered convincing explanations as to why Mr. Carmouze did not violate the Standard of Care in his overall treatment of A.M. and, in particular, in not attempting to intubate A.M. earlier than he did. Dr. Lee's testimony, while corroborating Dr. Lora's testimony, was cumulative and of little weight. A.M. was reported to be awake, alert, and oriented. She was breathing, albeit with difficulty, on her own. Therefore, it was appropriate for Mr. Carmouze to attempt the other measures to assist her breathing he instituted. Mr. Cary's testimony, while credible, was not convincing, especially given Dr. Lora's expert opinions. Mr. Cary's testimony was taken during a discovery deposition by Respondent and, as a result, the benefit of his testimony to Petitioner's case was limited. The evidence failed to prove that Mr. Carmouze violated the standard of care: In his treatment of A.M.; By failing "to contact his supervising physician, the ED director, and/or Patient A.M.'s primary physician for assistance in treating Patient A.M."; By failing "to identify a treatment plan for Patient A.M."; and By failing "to consult his supervising physician prior to ordering Demerol, a controlled substance, for Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M." Mr. Carmouze's Treatment Plan and Medical Records for Patient A.M. Mr. Carmouze, as the Department has conceded in Petitioner's Proposed Recommended Order, paragraph 13, page 20, did identify a treatment plan for Patient A.M. Having found that Mr. Carmouze did not err when he did not initiate intubation of A.M. earlier than he did, the evidence failed to prove that "he failed to maintain medical records that justified the course of treatment in that he failed to record a reason for not intubating sooner in an attempt to address Patient A.M.'s respiratory distress." There is no indication in Mr. Carmouze's medical records for A.M. that Mr. Carmouze attempted to contact Dr. Ajit or Dr. Fernandez-Gonzalez. The medical records do indicate, however, that A.M.'s primary physician, Dr. Sanaullah, was "notified and arrived for code." While the evidence did not prove who notified Dr. Sanaullah, Petitioner failed to prove that Mr. Carmouze was not responsible for Dr. Sanaullah's notification. Mr. Carmouze failed to identify himself by name or professional title in A.M.'s medical records. He also failed to include Dr. Fernandez-Gonzalez's name and title in A.M.'s medical records. Mr. Carmouze did not ensure that either the signature of his supervising physician or Dr. Ajit was included on A.M.'s medical records. While the quality of Mr. Carmouze's medical records for A.M. was correctly characterized as "minimally acceptable" by Mr. Cary, the evidence failed to prove clearly and convincingly that those medical records were not adequate. This finding is based upon the lack of an unequivocal opinion from Mr. Cary concerning the adequacy of the medical records and a comparison of Mr. Cary's opinions with those of Dr. Lee in support of Mr. Carmouze's medical records for Patient A.M. Mr. Cary, on the one hand, made the following negative comments about Mr. Carmouze's medical records for A.M: "[T]he record isn't really clear on what did happen because he did not write down any times on intervention of what he did." Petitioner's Exhibit numbered 1, page 14; "[W]hen you look at this face sheet here you don't get a picture of what happened and at what time, there's no real times there, no progression of the treatment." Petitioner's Exhibit numbered 1, page 67. Mr. Cary stated that there was no time noted in Patient A.M.'s history/physical section, and that a portion of that section was illegible. Petitioner's Exhibit numbered 1, page 21 and 25. On the other hand, Mr. Cary stated that "[the medical record for A.M.] is minimally acceptable, it just doesn't give a good clear picture of the sequence of events." Petitioner's Exhibit numbered 1, page 68. Mr. Cary also stated the following when asked if he thought Mr. Carmouze maintained medical records that justified the course of his treatment regarding Patient A.M.: "There were medical records that were there, I think they could have been more complete and more detailed . . . ." These statements, taking into account the fact that Mr. Cary was able to read almost all of Mr. Carmouze's medical record pertaining to A.M. on direct examination by counsel for Mr. Carmouze, reduces the effectiveness of his other opinions. Finally, it is noted that all of Mr. Carmouze's experts, along with Mr. Cary, were able to read Mr. Carmouze's notes, other than a word or two. Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. Patient C.M. On April 23, 2002, Patient C.M., a 20-year-old male presented to Mr. Carmouze at Weems' ER. C.M. complained of a server headache. In pertinent part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril. Patient J.S. On April 24, 2002, Patient J.S., a 37-year-old female presented to Mr. Carmouze at Weems' ER. J.S. complained of a burn. In pertinent part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril. Patient B.M. On April 24, 2002, Patient B.M., a 46-year-old female, presented to Mr. Carmouze at Weems' ER. B.M. complained of a headache of two-days' duration. In pertinent part, Mr. Carmouze ordered 25 milligrams of Demerol administered to B.M. at the ER. Mr. Carmouze noted in the medical record for B.M. a diagnosis of scabies/headache cluster, severe. This is the only diagnosis made at Weems' ER for B.M. Patient R.M. On April 24, 2002, Patient R.M., a 73-year-old male, presented to Mr. Carmouze at Weems' ER. R.M. complained of abdominal pain and constipation of several days’ duration. In patient part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril administered to R.M. at the ER. Mr. Carmouze noted in the medical record for R.M. a diagnosis of abdominal pain, impaction. This is the only diagnosis made at Weems' ER for R.M. Patient M.F. On April 25, 2002, Patient M.F., a 34-year-old female, presented to Mr. Carmouze at Weems' ER. M.F. complained of left-flank pain. In relevant part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril administered to M.F. at the ER. Mr. Carmouze noted in the medical record for M.F. a diagnosis of left-flank pain, left nephrolithiasis. Patient G.C. On June 7, 2002, Patient G.C., a 20-year-old male, presented to Mr. Carmouze at Weems' ER. G.C. complained of right-flank pain. In relevant part, Mr. Carmouze ordered two separate doses of Demerol, 50 milligrams each, and Vistaril, 50 milligrams each. Patient G.B. On June 7, 2002, Patient G.B., an 83-year-old female, presented to Mr. Carmouze at Weems' ER. G.B. complained of wrist, knee, and leg pain, secondary to a fall. In relevant part, Mr. Carmouze ordered two separate doses of Demerol, 50 milligrams each, and Vistaril, 50 milligrams each. Mr. Carmouze noted in the medical record for G.B. a diagnosis of chest contusion, leg edema, and right Colles' fracture. This is the only diagnosis made at Weems' ER for G.B. Patient K.S. On June 8, 2002, Patient K.S., an 18-year-old female, presented to Mr. Carmouze at Weems' ER. K.S. complained of lower back pain secondary to a fall. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for K.S. a diagnosis of intractable back pain, trauma to spine. This is the only diagnosis made at Weems' ER for K.S. Patient C.W. On June 8, 2002, Patient C.W., a 46-year-old female, presented to Mr. Carmouze at Weems' ER. C.W. complained of headache and dizziness. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for C.W. a diagnosis of headache and anemia. This is the only diagnosis made at Weems' ER for C.W. Patient M.A.C. On June 9, 2002, Patient M.A.C., a 49-year-old female, presented to Mr. Carmouze at Weems' ER. M.A.C. complained of pain in the lower right abdomen and back. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for M.A.C. a diagnosis of diabetes mellitus and abdominal pain. This is the only diagnosis made at Weems' ER for M.A.C. Patient R.S. On June 9, 2002, Patient R.S., a 34-year-old male, presented to Mr. Carmouze at Weems' ER. R.S. complained of shoulder pain. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for R.S. a diagnosis of right shoulder tendon tear. This is the only diagnosis made at Weems' ER for R.S. Patient K.M. On June 11, 2002, Patient K.M., a 52-year-old male, presented to Mr. Carmouze at Weems' ER. R.S. complained of wrist pain secondary to a fall. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for K.M. a diagnosis of a Colles' fracture. This is the only diagnosis made at Weems' ER for K.S. Facts Common to Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. Mr. Carmouze did not note in his medical records for Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. (hereinafter referred to jointly as the "Pain Patients "), that he had consulted with Dr. Fernandez- Gonzalez or Dr. Ajit prior to ordering Demerol for the Pain Patients. Demerol is a controlled substance. Dr. Fernandez-Gonzalez' testimony regarding alleged consultations he had with Mr. Carmouze concerning the Pain Patients and other patients seen by Mr. Carmouze while at Weems is rejected as lacking credibility for the reasons explained, supra. Mr. Carmouze also failed to note in the medical records for the Pain Patients his name and professional title. His name was stamped on the Emergency Room Record he completed for Patients M.A.C., G.M., and R.S. His name was also written into the space under "Time/Initials" on the Emergency Room Record for Patients M.A.C., C.W., R.M., and J.S. None of these records, however, included his title of "physician assistant." Mr. Carmouze failed to identify Dr. Fernandez-Gonzalez or Dr. Ajit by name and professional title in the medical records of the Pain Patients. Mr. Carmouze failed to ensure that the signature of Dr. Fernandez-Gonzalez or Dr. Ajit was included in the medical records of the Pain Patients. The Other "106 Patients". While at Weems ER, Mr. Carmouze provided medical services, in addition to A.M. and Pain Patients, to 106 other patients at issue in this case (hereinafter referred to as the "106 Patients"). Petitioner's Exhibit numbered 4 is a composite exhibit of medical records for the 106 Patients. There are approximately two patients for whom more than one medical record has been included in Petitioner's Exhibit numbered 4. The foregoing findings relate to the 108 medical records for the 106 Patients. Mr. Carmouze failed to note in most of the medical records for the 106 Patients his name and professional title. Of the approximately 108 records, Mr. Carmouze's name does not appear in any fashion on 48 of them. The rest either include his name (but not title) either stamped on the record or written into the box titled "Time/Initials." On two of the medical records both Mr. Carmouze's name and "P.A." have been written into the box titled "Time/Initials." Mr. Carmouze failed to identify Dr. Fernandez-Gonzalez or Dr. Ajit by name and professional title in the medical records of the 106 Patients. Mr. Carmouze did not ensure that either the signature of his supervising physician or Dr. Ajit was included on the medical records of the 106 Patients.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that, Arnaldo Carmouze, P.A., has violated Subsections 458.331(1)(m) and (v), Florida Statutes, as described in this Recommended Order; issuing a reprimand; placing Mr. Carmouze's license on probation for one year; requiring that he pay an administrative fine of $5,000.00; requiring that he perform five hours of CME in a subject(s) determined appropriate by the Board; and suspending his license for six months (with the suspension stayed provided he complies with probation). DONE AND ENTERED this 13th day of December, 2006, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 13th day of December, 2006. COPIES FURNISHED: Irving Levine Matthew Casey Assistants General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Julie Gallagher, Esquire Greenberg Taurig, P.A. 101 East College Avenue Tallahassee, Florida 32301 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. M. Rony François, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
Findings Of Fact At all times relevant hereto Daniel Francis Sanchez was licensed as a physician by the Florida Board of Medical Examiners having been issued license number ME0038795. At all times relevant hereto Respondent was Regional Medical Director of IMC which operated HMO offices in Hillsborough and Pinellas Counties. On October 17, 1985, Alexander Stroganow, an 84 year old Russian immigrant and former cossack, who spoke and understood only what English he wanted to, suffered a fall and was taken to the emergency room at Metropolitan General Hospital. He was checked and released without being admitted for inpatient treatment. Later that evening his landlady thought Stroganow needed medical attention and again called the Emergency Medical Service. The ambulance with EMS personnel arrived and concluded Stroganow was no worse than earlier when taken to the emergency room and they refused to transport him again to the hospital. The landlady then called the HRS hotline to report abuse of the elderly. The following morning, October 18, 1985, an HRS case worker was dispatched to the place where Stroganow lived. She was let in by the landlady and found an 84 year old man who was incontinent, incoherent, apparently paralyzed from the waist down, with whom she could not carry on a conversation to find out what condition he was in. She called for a Cares Unit to come and evaluate the client. An HRS Cares Unit is a two person team consisting of a social worker and nurse whose primary function is to screen clients for admission to nursing homes and adult congregate living facilities (ACLF). The nurse on the team carries no medical equipment such as a stethoscope, blood pressure cuff, or thermometer, but makes her determination on visual examination only. Upon arrival of the Cares Unit both members felt Stroganow needed to be placed where he could be attended. A review of his personal effects produced by his landlady showed his income to be over the maximum for which he could qualify for medicaid placement in a nursing home; that he was a member of IMC's Gold- Plus HMO; his social security card; and several medications, some of which had been prescribed by Dr. Dayton, a physician employed by IMC at the South Pasadena Clinic. The Cares team ruled out ACLF placement for Stroganow at the time because he was not ambulatory but felt he needed to be placed where he could be attended to and not left alone over the coming weekend. To accomplish this, they proceeded to the South Pasadena HMO clinic of IMC to lay the problem on Dr. Dayton, the Assistant Medical Director for IMC in charge of the South Pasadena Clinic. Stroganow had been a client of the South Pasadena HMO for some time and was well known at the clinic and by EMS personnel. There were two and sometimes three doctors who treated patients at this clinic and, unless the patient requested a specific doctor, he was treated by the first doctor available. Stroganow had not specifically requested he be treated by Dr. Dayton. When the Cares team met with Dr. Dayton they advised him that Stroganow had been taken to Metropolitan General Hospital Emergency Room the night before but did not advise Dayton that the EMS team had refused to transport Stroganow to the hospital emergency room a second time the previous evening. Dayton telephoned the emergency room at Metropolitan General to ascertain the medical condition of Stroganow when brought in the evening before. With the information provided by the Cares team and the hospital, Dayton concluded that Stroganow should be given a medical evaluation and the quickest way for that to occur was to call the EMS and have Stroganow taken to an emergency room for evaluation. When the Cares team arrived, Dayton was treating patients at the clinic. A doctor's office, or clinic, is not a desirable place to have an incontinent, incoherent, non- ambulatory patient brought to wait with other patients until a doctor is free to see him. Nor is the clinic equipped to do certain procedures frequently needed in diagnosing the illness and determining treatment needed for an acutely ill patient. EMS squads usually arrive within minutes of a call to 911 for emergency medical assistance and it was necessary for someone to be with Stroganow with the EMS squad arrived. Accordingly, Dayton suggested that the Cares team return to Stroganow and call 911 for assistance in obtaining a medical evaluation of Stroganow. If called from the HMO office, the EMS squad would have arrived long before the Cares team could have gotten back to Stroganow. Dr. Dayton did not have admitting privileges at any hospital in Pinellas County at this time. Upon leaving the South Pasadena HMO clinic, the Cares team returned to Stroganow. Enroute, they stopped to call a supervisor at HRS to report that the HMO had not solved their problem. The supervisor then called the Administrator at IMC to tell them that one of their Gold-Plus patients had an emergency situation. Respondent, Dr. Sanchez, called and advised that Dr. Dayton would take care of the problem. Later, around 2:00 p.m. when no ambulance had arrived, the Cares team called 911 from a telephone a block away from Stroganow's residence and arrived back just before the emergency squad. The EMS squad again refused to transport Stroganow to an emergency room and this information was passed back to Sanchez who directed that Stroganow be taken to Lake Seminole Hospital. This was the first time either Dayton or Sanchez was aware that the EMS squad had refused to transport Stroganow to an emergency room. Although Sanchez did not have admitting privileges at Lake Seminole Hospital, IMC had a contractual agreement with Lake Seminole which provided that certain staff doctors at Lake Seminole would admit patients referred to Lake Seminole by IMC. Pursuant to this contractual arrangement, Stroganow was admitted to Lake Seminole Hospital where he was treated for his injuries and evaluated for his future medical needs.
Findings Of Fact At all times material hereto, Respondent has been licensed to practice medicine in the State of Florida, having been issued license number ME-0027913, and was employed by the Norton Seminole Medical Group in Pinellas County, Florida. Respondent has been licensed in Florida since 1976. At approximately 3:50 p.m. on November 1, 1983, a 31 year old white male, with the initials R. L., arrived at the emergency room of Lake Seminole Hospital, Seminole, Florida, and was examined by the emergency room physician on duty. R. L. complained of substernal mid-chest pain radiating to his back, which had begun the night before. He was agitated and exhibited a great deal of emotional stress. The emergency room physician on duty treated R. L. for suspected cardiac pathology, placed him on a cardiac monitor, inserted a heparin lock into a vein, and ordered lab work which included a chest x-ray, electrocardiogram, electrolytes, cardiac enzymes, CBC (complete blood count), blood sugar, creatinine and BUN (blood urea nitrogen). These were appropriate tests under the circumstances. When the Respondent came on duty in the emergency room at 7:00 p.m., all lab work had been completed, except for the cardiac enzymes. The emergency room physician who had been on duty when R. L. appeared at the emergency room briefed Respondent about R. L.'s medical history, condition while in the emergency room, and the test results which had been received. After the cardiac enzyme values were received, Respondent reviewed R. L.'s medical history and lab test results, which he determined to be normal, and discharged R. L. at approximately 7:35 p.m. on November 1, 1983, with instructions that he see his family physician the next morning. Respondent's discharge diagnosis for R. L. was atypical chest pain secondary to anxiety. At approximately 11:21 p.m. on November 1, 1983, R. L. expired from cardiopulmonary arrest at the emergency room of Metropolitan Hospital, Pinellas Park, Florida. The autopsy report notes extensive coronary artery disease, but makes no mention of acute myocardial infarction. It was not established by clear and convincing evidence that R. L. suffered an acute myocardial infarction. There is conflicting expert testimony from Steven R Newman, M.D., and Stephen J. Dresnick, M.D., concerning whether Respondent should have admitted R. L. to Lake Seminole Hospital instead of discharging him from the emergency room, and also whether his E.K.G. taken at the emergency room was normal. Drs. Newman and Dresnick are experts in the care and treatment of patients in an emergency room, but their testimony was received by deposition instead of through live testimony at hearing. Thus, based upon this conflict in testimony, and the fact that the demeanor of these witnesses cannot be assessed, it is found that it was not established by clear and convincing evidence that Respondent failed to practice medicine with that level of care and skill which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances when he discharged R. L., and evaluated the tests which were administered to the patient while in the emergency room as within normal limits. A patient who appears at a hospital emergency room with unstable angina, such as R. L., does not necessarily require admission to the hospital. While serial electrocardiograms and serial cardiac enzymes are called for with patients whose symptoms of cardiac discomfort warrant hospitalization, these procedures are not usually and customarily performed in an emergency room. Therefore, since it was not established that Respondent should have admitted R. L. to the hospital as an in-patient, it was also not established that he failed to exercise the required level of skill and care by failing to order such serial tests while R. L. was in the emergency room. Although the emergency room physician on duty when R. L. arrived at the emergency room at approximately 3:50 p.m. on November 1, 1983, was initially responsible for obtaining a patient history and ordering the tests which were performed, when Respondent came on duty at 7:00 p.m. and took over this case, he was also responsible for insuring that his medical records concerning his evaluation and treatment of R. L., as well as his decision to discharge the patient, were full and complete. Respondent failed to document his review and findings based upon the lab tests and chest x-ray which had been completed, as well as the patient's medical history, and the specific reason or basis for his decision to discharge R. L. Respondent relied almost completely on the medical records compiled by the emergency room physician who was initially on duty when R. L. arrived at the emergency room, and made no significant additions to those records while the patient was under his care, or which would justify his course of treatment, including discharge, of this patient.
Recommendation Based upon the foregoing, it is recommended that the Board of Medicine enter a Final Order reprimanding Respondent for his violation of Section 458.331(1)(m), Florida Statutes, and placing him on probation for a period of six months from the entry of the Final Order in this case, conditioned upon his complying with such reasonable terms and conditions as the Board may impose, including review and verification of the completeness of medical records prepared by the Respondent while on probation. DONE AND ENTERED this 5th day of July, 1990 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 5th day of July, 1990. APPENDIX (DOAH CASE NO. 89-6874) Rulings on the Department's Proposed Findings of Fact: 1-2. Adopted in Finding of Fact 1. 3-4. Adopted in Finding of Fact 2. 5-6. Adopted in Finding of Fact 3. 7. Adopted in Finding of Fact 4. 8-9. Rejected in Finding of Fact 5. 10. Rejected in Finding of Fact 4. 11-12 Rejected in Finding of Fact 6. 13. Adopted in part in Finding of Fact Rejected in Findings 5 and 6. 7, but otherwise Rulings on the Respondent's Proposed Findings of Fact: Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2 and 3. 4-5. Adopted in Finding of Fact 2. 6. Adopted in Finding of Fact 3. 7-9. Adopted in Finding of Fact 4. Rejected in Finding of Fact 5. Rejected in Finding of Fact 7. 12-13. Adopted in Finding of Fact 6. Adopted in part in Finding of Fact 2, but otherwise Rejected in Finding of Fact 5. Adopted in Finding of Fact 5. Rejected in Finding of Fact 7. COPIES FURNISHED: Andrea Bateman, Esquire Kevin F. Dugan, Esquire 1940 North Monroe Street Wittner Centre West Suite 60 Suite 103 Tallahassee, FL 32399-0792 5999 Central Avenue St. Petersburg, FL 33710 Kenneth E. Easley, Esquire General Counsel 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, he then had an "emergency medical condition," as defined by Section 395.002(8)(a) F.S. Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, MRMC provided to the patient appropriate "emergency services and care," including an appropriate "medical screening, examination and evaluation," as defined by Section 395.002(9) F.S., and as required by Section 395.1041 F.S., and if not, how shall MRMC be disciplined?
Findings Of Fact At all times material, J.B. was a 42 year old male employee of an Ocala music store. In that capacity, he had been moving pianos for years. As a result, he had experienced neck, shoulder and back pain off and on for years. The pain and stiffness was worst upon awaking in the mornings and frequently required two days' bed rest before he could return to work. In the week preceding Monday, May 22, 1995, J.B.'s neck and shoulder pain had intensified. On Friday, May 19, 1995, J.B. went to a walk-in clinic, CARE-ONE, because his primary care physician was out of town. He was examined by a physician; x-rays were taken; he was issued a soft cervical collar; and he was prescribed a muscle relaxer and pain medication, both of which are "scheduled" drugs. The CARE-ONE physician also advised him to see a neurosurgeon for further evaluation and treatment. Despite his use of the prescribed drugs, J.B.'s pain intensified further over the weekend, to the point he was weeping and vomiting on occasion. He also had new pain in his left arm. At all times material, Respondent MRMC in Ocala, Florida, was licensed as a Class I general hospital with an emergency department. MRMC's emergency department handles upwards of 40,000 patient visits annually. At 8:15 a.m. on Monday, May 22, 1995, J.B.'s wife, L.B., took him to the MRMC emergency department. The term, "triage", generally refers to a means of sorting and prioritization of patients based on a superficial initial examination to determine how rapidly they will be seen in a mixture of patients who have differentiated complaints. Emergency department Board-certified physicians established MRMC's medical triage protocols in 1989. In so doing, MRMC has melded the concept of initial patient evaluation and "triage" into one process, and has authorized registered nurses, among other health care professionals, to perform both functions. MRMC's emergency department staff numbers 75 FTEs at all times, plus physician and physician assistant components. Physicians are available on the premises 24 hours a day for any consultation that may be required. At all times material, Geraldine Sweeney was an MRMC Clinical III Emergency Department Triage Nurse. As such, she maintains 24 hours of continuing education units per years (twice the number required to maintain her R.N. license). She also regularly participates in in-service training in emergency department nursing. These courses regularly include neurological topics and she has encountered and assessed numerous neurological cases over her 16 years in MRMC's emergency department, six of them as triage nurse since MRMC established its dedicated triage system in 1989. Ms. Sweeney has both an associate of arts and an associate of science degree in nursing; is a fully licensed Registered Nurse; and has never had any disciplinary action taken against her license. She was accepted as an expert in hospital emergency nursing. At formal hearing, J.B. did not remember being seen by any health care professional at MRMC on May 22, 1995. His wife, L.B., was attending to registration procedures with an MRMC admittance clerk in a different room and was not present when J.B. was assessed at MRMC's emergency department on that date, but she knew he was taken to a different room by a female hospital employee whom L.B. presumed to be a nurse. Geraldine Sweeney, R.N., did not recognize J.B. at formal hearing. She has "triaged" at least 1,000 patients since May 22, 1995. However, despite these three witnesses' lapses in memory or lack of opportunity to observe and/or lack of independent recollection, MRMC's documentation for May 22, 1995, in Ms. Sweeney's handwriting and bearing her signature, shows that Ms. Sweeney is the only MRMC health care professional who performed its initial, and only, assessment of J.B. at MRMC on May 22, 1995. Ms. Sweeney's contemporaneous documentation of her examination of J.B. shows he arrived at MRMC's emergency department at 8:15 a.m. and was "triaged" at 8:15 a.m. She wrote down that subjectively, he presented with a "history of neck problems with spasms; now has pain into left arm; seen at CARE-ONE Friday; had x-rays; given valium and lortab; advised for neurosurgeon." His objective vital signs were recorded by Ms. Sweeney as, "temperature 36.4 C., pulse 62, respiration 20, blood pressure 130/75." No weight was recorded. The only other significant objective triage data Ms. Sweeney recorded was, "Wearing soft collar; ambulates well; grips equal." Ms. Sweeney classified J.B. according to MRMC's physician-established protocols as "Class I, not requiring immediate attention," and he was released from the MRMC emergency department at 8:25 a.m., just ten minutes after his arrival. At that time, he was provided with a written list of other treatment locations to which he could go, including CARE-ONE again, and his personal physician. This list did not name any other hospital emergency department. Richard S. Slevinski, M.D., is Board-certified in emergency medicine and is director of the emergency department at Baptist Hospital in Pensacola, Florida, which includes a Level II Trauma Center. He was accepted as an expert in emergency and general medicine. Dr. Slevinski and Nurse Sweeney testified that a loss of function is a significant phenomenon that should have been recorded in a proper evaluation. Ms. Sweeney testified that if J.B. had identified loss of function as a symptom to her or if she had discovered a loss of function during her examination, she would have noted that and followed up with additional tests, but J.B. did not subjectively describe loss of function and she did not objectively observe any loss of function. Dr. Slevinski and Nurse Sweeney testified that a change in function or location of pain, increase in intensity of pain or recent onset of pain are subjective indicators that should be recorded if related by the patient during an examination and evaluation. Ms. Sweeney testified that she would have recorded any of these subjective symptoms if J.B. had related them to her, but he did not. Nurse Sweeney also testified that none of the objective vital signs she recorded during her examination of J.B. on May 22, 1995 indicated severe or intense pain. This was corroborated by neurosurgeon Dr. Barry Kaplan. (See Finding of Fact 32) I accept Dr. Slevinski's expert opinion that as a medical physician, he has found that if a service was provided in an emergency department it should be documented, and that it is the duty of the emergency department professional who performs patient screenings, examinations and evaluations to inquire adequately of a patient to find out what is going on with him or her and to make a chart so that later someone else can read the chart and see what the examiner did, and I reasonably infer from this expert testimony that, absent some strong evidence to the contrary, if a service has not been documented, the service has not been performed. This analysis, however, does not support a finding that J.B. actually told Nurse Sweeney on May 22, 1995 that his overall pain or his left arm pain was newly onset, that his pain had intensified, or that his pain was more localized in his left arm. J.B. has described his pain as chronic or recurring over a long period of time in testimony and when he saw Dr. Kaplan, a neurosurgeon, on June 1, 1995 (see Findings of Fact 27, 29), and J.B. can remember nothing about what he told Nurse Sweeney on May 22, 1995. Therefore, this is a situation in which Nurse Sweeney's testimony about what J.B. did not tell her is unrefuted, rather than the classic situation, described by Dr. Slevinski, in which a patient testifies as to what symptoms he told a health care professional and the chart shows the health care professional failed to record what the patient said. However, upon the evidence as a whole, it is found that no full neurological evaluation of J.B. was done by anyone at MRMC; that Nurse Sweeney did not individually feel each of his fingers to ascertain if he had sensation and similar temperature in each; and that she did not administer any muscle resistance tests. Rather, she had J.B. perform a "grip test". This "grip test" is performed by having the patient lift and cross his arms and reach out to the examiner. It tests whether the patient is able to maneuver both his own hands forward and grab onto the examiner's fingers with equal pressure, thereby indicating lack of loss of arm function. The test permits skin to skin contact so that any loss of sensation in the patient's hands or any change or inequality of skin temperature in the patient's hands or digits can be noted by the examiner. Upon her education, training, and experience, Nurse Sweeney thereby determined that J.B.'s grips were equal and his skin was a normal temperature, indicating no loss of function, sensation, or failure in circulation. Dr. Slevinski testified that, if J.B. had presented his CARE-ONE x- rays to her, Ms. Sweeney should have had the CARE-ONE x-rays read by a qualified physician, preferably a neurologist. Ms. Sweeney denied that J.B. brought his x-rays with him to MRMC, stating that if he had done so, she would have recorded that on the assessment form and would have had them read by a qualified physician instead of just recording, "had x-rays," which she had meant to show that J.B. had had x-rays taken the Friday before at CARE-ONE. J.B.'s testimony is clear on this single point to the effect that he had his wife take him to get the CARE-ONE x-rays and had them with him at MRMC. Marion Community Hospital documented that J.B. had the CARE-ONE x-rays with him at that facility at 9:23 a.m. (See Findings of Fact 24-25) This is corroborative of J.B.'s testimony on this issue. I therefore find that Ms. Sweeney overlooked those available CARE- ONE x-rays as part of her evaluation of J.B. Dr. Slevinski opined that MRMC, through Nurse Sweeney, did not provide an adequate medical screening examination for J.B.'s presenting complaint on May 22, 1995 because he was not given an appropriately sophisticated neurologic assessment or examination of the involved extremity (left arm) by a physician, preferably a neurologist; because the CARE-ONE x-rays J.B. brought with him were not reviewed by a qualified person; and because his pain was not stabilized. Specifically, Dr. Slevinski faulted Ms. Sweeney's use of a "grips" examination instead of an examination of J.B.'s status of sensation, strength of fingers, or reflex capabilities. He opined that Ms. Sweeney's examination, as documented, was insufficient to rule out that J.B. had a condition that was going to cause him further damage. It was Dr. Slevinski's opinion that "triage", as generally understood by the community of health care professionals, without more, cannot constitute an adequate or appropriate medical screening, examination, and evaluation. In Dr. Slevinski's view, severe pain alone qualifies as an emergent or emergency condition until an adequate examination proves that it is not. However, Dr. Slevinski conceded that pain is highly subjective and is only an "emergency medical condition" if the absence of immediate medical attention could reasonably be expected to result in serious jeopardy to the patient's health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. Upon further questioning, Dr. Slevinski opined that in general, a medical screening examination or evaluation need not always be done by a physician; that it can be done by a nurse or even a psychological case worker in the appropriate circumstances; and that in some, but not necessarily all patient presentations, there is no reason a triage nurse, within the scope of her license, if authorized to do so by the hospital, cannot perform a medical screening examination simultaneously with triage, although that is not his preference and although that was not appropriate in this case or in all cases. Dr. Slevinski commented also that a failure to correctly diagnose and treat after an appropriate screening, examination, or assessment might subject a hospital or individual health care provider to civil liability but would not violate Chapter 395 F.S. After J.B., still in pain, had been returned from the examining room, that is, only after Nurse Sweeney had already finished her evaluation of him and determined that he did not have an emergency medical condition requiring further emergency treatment and care, and while J.B. was standing beside L.B. facing the administrative clerk in the registration area of the MRMC emergency department, L.B. handed her insurance card to the clerk. The clerk then told L.B. that J.B. could not be treated at MRMC because he did not have either a referral from his primary treating physician or a life-threatening condition. An argument ensued, and L.B. demanded to know where else she could get treatment for J.B. She then drove J.B. directly to Marion Community Hospital's emergency department upon the suggestion of MRMC's admissions clerk. J.B. was clocked-in at 9:23 a.m. at the emergency department of Marion Community Hospital a/k/a "Columbia" or "HCA", where he was kept for about five hours. He was examined by an in-house neurologist who performed a limited "hands on" physical examination and a neurological examination. His vital signs were taken. He was injected intramuscularly with 30 milligrams of toradol, a "scheduled" pain killer. He was observed and re-evaluated after several hours. Additional x-rays were taken and reviewed by a radiologist who also reviewed the CARE-ONE x-rays J.B. had brought with him. J.B.'s valium and lortab prescriptions were refilled. He was released from Marion's emergency department with instructions to call and schedule an MRI and also to see his own physician and a neurosurgeon. The only medical "treatment" J.B. received at Marion was for pain. The final result after Marion's extensive and expensive screening examination and evaluation was the same as had occurred at MRMC: that he was released because he had no emergency medical condition requiring further emergency medical treatment in that facility at that time. Barry Kaplan, M.D., is the Board-certified neurosurgeon who eventually performed successful surgery on J.B. Dr. Kaplan first saw J.B. in his office on July 1, 1995. The length of this visit is not clear on the record. J.B.'s general description to him was that of chronic pain. Apparently J.B. had gone back to work for part of the time between May 22, 1995 and seeing Dr. Kaplan on June 1, 1995. On June 1, 1995, Dr. Kaplan did a complete neurologic examination, which included testing J.B.'s muscle actions against resistance. He also felt all of J.B.'s fingers, individually, while asking about sensation in each. These tests revealed only mild weakness or dysfunction in the bicep muscle of J.B.'s left arm and only mild numbness or dysfunction in his left arm. Dr. Kaplan also reviewed an MRI taken of J.B. on May 31, 1995 which demonstrated a chronic arthritic condition of J.B.'s neck, with bone spurs pressing the nerves running to his left arm and spinal cord, which resulted in J.B.'s pain. In Dr. Kaplan's opinion as an expert in neurosurgery and general medicine, J.B.'s condition on June 1, 1995, could not have developed measurably within the time elapsed since his visit to the MRMC emergency department on May 22, 1995 or even within the last month, because on June 1, 1995, J.B. had no acute symptoms of sufficient severity that he then had immediate need of treatment, nor was there any reasonable expectation that lack of treatment could be expected to result in serious jeopardy to his health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. On June 1, 1995, Dr. Kaplan believed that J.B.'s condition could be left alone for another four to six months before any permanent injury would occur to his spinal cord, but due to J.B.'s intense and chronic pain and relative youth, he recommended elective surgical removal of certain discs. Dr. Kaplan did the recommended elective surgery at J.B.'s request on July 12, 1995 at MRMC. J.B. has been pain-free since recovery. Dr. Kaplan's opinion also was that none of the objective vital signs recorded by Nurse Sweeney on May 22, 1995 would be consistent with severe pain. Although he was aware that Nurse Sweeney did not record giving a numbness test, weakness test, or reviewing x-rays on May 22, 1995, Dr. Kaplan also opined that, "Unless somebody has quadriparesis or complete dysfunction of a part from a cervical disc problem, then it is not an emergent condition . . . . Unless they have severe weakness or numbness to go along with the pain, there's no indication for emergency intervention." Dr. Kaplan's opinion also was that no serious jeopardy could have been incurred by J.B. not receiving further emergency services and treatment beyond MRMC's initial assessment on May 22, 1995. No health care witness set a minimum time necessary to conduct an appropriate examination. All indicated that the time involved and appropriate tests varied from case to case.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the administrative complaint herein. RECOMMENDED this 17th day of December, 1996, at Tallahassee, Florida. ELLA JANE P. DAVIS 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 17th day of December, 1996. COPIES FURNISHED: Thomas W. Caufman, Esquire Agency for Health Care Administration 7827 North Dale Mabry Highway No. 100 Tampa, Florida 33614 Thomas D. Watry, Esquire 1500 Marquis Two Tower 285 Peachtree Center Avenue Northeast Atlanta, Georgia 30303 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Jerome W. Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue The issue in this case is whether an application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital (“Wolfson”), to operate a pediatric trauma center should be approved.
Findings Of Fact The following findings of fact are derived from the stipulation of the parties, the admitted exhibits, and the testimony at final hearing. DOH is the state agency responsible for, inter alia, the review and approval (or denial) of applications to operate trauma centers, including pediatric trauma centers. DOH denied the trauma center application filed by Wolfson, not due to an absence of need in the area, but due to Wolfson’s failure to comply with some requirements set forth in the application. Wolfson is a 216-bed not-for-profit children’s hospital located in Jacksonville, Duval County, Florida. It is part of the Baptist Health organization and is one of three hospitals operated under that entity’s license. Wolfson is located on the same campus as Baptist Medical Center – Jacksonville. The two hospitals share a pharmacy which is located in the children’s hospital and a laboratory located in the adult hospital, but no other services or staff. Interestingly, Wolfson was developed by the sons of Morris Wolfson, a Jewish immigrant to the United States. One of Mr. Wolfson’s children had died at an early age due to lack of access to health care services. Later in his life, after acquiring a small fortune from his business, Mr. Wolfson asked his five remaining sons to develop a children’s hospital accessible to every child, regardless of race, creed, or religious affiliation. By 1951 the sons had raised over half a million dollars and were prepared to construct a hospital. They approached the Baptists, who agreed to build the children’s hospital as part of their development of Baptist Hospital. In 1955, Mr. Wolfson’s dream became a reality. Wolfson provides a wide range of services to children, including but not limited to: two neonatal intensive care units; cardiac catheterization; open heart surgery; bone marrow transplants; and extracorporeal membrane oxygenation, a less complex bypass procedure. There is an emergency department at Wolfson. It receives approximately 60,000 patients per year. Wolfson also operates three satellite emergency departments and has three mobile ICUs (known as “Kids Kare” mobile units). Wolfson’s service area is quite large, comprised of a triangle identified by the vertices of Savannah, Georgia – Dothan, Alabama – and Daytona Beach, Florida. About ninety percent of Wolfson’s patients come from within that area. There is not currently a pediatric trauma center in Jacksonville, which is located in Trauma Service Area (“TSA”) 5. There are five counties in TSA 5: Duval, Baker, Clay, Nassau, and St. Johns. The closest pediatric trauma center to Jacksonville is located in Gainesville, Alachua County, Florida, some 60 miles away. There is a Level II trauma center located at UF Health Jacksonville, but it is not specifically for pediatrics. There are differences in the provision of care to pediatric patients versus adult trauma patients, including specialized equipment, age-appropriate drugs, and modified procedures. Pediatric trauma patients from TSA 5 must be transported to UF Health Jacksonville or Shands in Gainesville. Some of those patients are designated as “trauma alert patients.” Those are individuals identified by emergency medical services as requiring immediate, high-level treatment by skilled professionals. Not all trauma patients are trauma alert patients. Once a pediatric trauma patient has been stabilized at UF Health Jacksonville or Shands, the patient can be transferred to Wolfson for further treatment. Wolfson then undertakes the care needed by the patient. UF Health Jacksonville transfers about 20 to 30 pediatric trauma patients per month to Wolfson. Not all of those patients have previously been deemed trauma alert patients, but Wolfson has extensive experience treating patients with significant needs. It is Wolfson’s desire to operate its own pediatric trauma center, thereby obviating the need for a trauma patient to first go to UF Health Jacksonville or Shands before being transferred. There are times when a delay in transfer can have negative consequences for the patient. The number of such occurrences was not quantified by Wolfson, but Wolfson considers it a significant problem. There is, by rule, a very precise process for a hospital to obtain verification as a trauma center. There are three stages to the process: provisional review, in-depth review, and site visit. Hospitals are given only one opportunity each year to apply for verification. In order to apply, a hospital must file a letter of intent (“LOI”) between September 1 and October 1. On or before October 15, the Department sends an application package to each hospital which had timely submitted an LOI. After receiving the application package, a hospital has until April 1 of the following year to complete and submit the application. DOH must complete its provisional review of the application and notify the applicant, by April 15, of any deficiencies which should be addressed. The hospital then has five business days to submit clarifying or corrective information. In accordance with this process, Wolfson timely filed its application to operate a pediatric trauma center. By rule, the application must contain responses and support relating to nineteen “critical elements” related to trauma care. The Department then reviews the application to make sure that all minimum standards for approval have been met. An applicant is not required to necessarily satisfy each element or subpart of a standard in order for it to be approved by the Department. However, failure to comply with a critical element overall can result in denial of the application. The initial review of an application by the Department is extremely important because, if provisionally approved, the applicant can immediately commence operating as a trauma center. In the present case, Wolfson’s application was reviewed by two persons under contract with the Department: Dr. Robert Reed and Susan Cox, RN. The Department deems each of those persons to be an expert in the field of trauma care based on their background and training. The provisional review by the reviewers was for the purpose of determining whether the application was complete and whether the hospital satisfied the critical elements required for a trauma center. After completion of their initial review, the reviewers sent a letter to Wolfson identifying certain deficiencies they had found in the application. There were a number of deficiencies identified by Dr. Reed and Nurse Cox in Wolfson’s application. However, the most important of those (and the ones at issue in this proceeding) were as follows: Standard II.B.1.b relates to trauma-related continuing medical education (“CME”) requirements for emergency physicians; Standard XVII relates to required multidisciplinary conferences which must be held throughout the year; and Standard XVIII addresses Quality Management a/k/a Quality Improvement (“QI”), also referred to as Performance Improvement. Wolfson was given an opportunity to address each of the stated deficiencies and did, in fact, submit some additional information. Despite the additional information, Wolfson’s application was still deemed insufficient and was denied. The Department now concedes that the CME standard was satisfied in Wolfson’s application. The same is true for the standard relating to multidisciplinary conferences. The QI standard (Standard XVIII), however, remains in dispute. DOH contends that the information submitted by Wolfson in its initial application and deficiency response falls short of proving compliance with this critical element. The QI standard requires a system of procedures and protocols that will promote performance improvement while maintaining patient safety. The goal is to establish processes to ensure a hospital is continually improving the quality of care provided. The subparts of the QI standard require detailed demonstrations of various processes, including: A.2 – A clearly defined performance improvement program for the trauma population; – Review of all trauma patient records from five specified categories; – Monitoring of six indicators relevant to the respective facility (which are in addition to four state-mandated indicators); – Review of cases relevant to the six indicators by the trauma medical director (“TMD”) and trauma program director (“TPD”), to decide whether the cases should be referred to the quality management committee (“QMC”). B.5 – Evaluation by QMC of the effectiveness of action taken to ensure problem resolution; – Preparation and submittal of a quarterly report showing which cases have been selected for corrective action; and – Maintenance of an in-hospital trauma registry with information on patients being treated. The gist of Wolfson’s QI program is set forth on a flow chart contained in the application. That chart is entitled, “Trauma PI Process: Levels of Review.” Though not explained at final hearing, the “PI” in the chart is presumably “Performance Improvement.” The flow chart indicates there to be a primary (daily) review, a secondary (weekly) review, and a tertiary (monthly) review involving certain designated persons. In each of the “boxes” for the respective reviews, there is a stated purpose for the review. For the primary review, the purpose is stated as: Identification of opportunities for Improvement/Validation. The secondary review’s purpose is: Adverse Event/Audit Filter Review. And the purpose of the tertiary review is: Peer Review/Accountability Determination, Loop Closure Plan, Trended Data Review. Phases of care identified in the flow chart are: Pre- hospital, Resuscitation, Inpatient Care Review, and Readmission Review. There is a list of “actions” in the flow chart: Education; Counseling; Trend Report; Guidance/Policy/Protocol Development; and Hospital PI Project. From that list, there is an arrow pointing back toward the primary review box. There is no narrative in the flow chart to explain how the various boxes interconnect or how the information therein ties to the requirements as outlined in the application form. Wolfson asserts that all relevant information is contained in the flow chart, whether in narrative form or not. There is also additional information in the application, attached as a “Scope of Services” addendum, which further elucidates what is found in the flow chart. The Department deems the flow chart and scope of services information insufficient for determining whether the proposal satisfies the critical elements. Wolfson says the flow chart is a “clearly defined performance improvement program.” It is, in fact, only an outline of a clearly defined program. The testimony provided at final hearing by Wolfson’s TPM explained how that outline would work to improve performance. With that explanation, the flow chart/scope of service information minimally satisfies this critical element of the application. Wolfson maintains that the information provided supports the requirement for review of all records from five specified categories, i.e., all trauma alert cases, critical or ICU admissions, operating room admissions for traumatic injury, critical trauma transfers, and in-hospital deaths. Upon review of the flow chart there is insufficient evidence concerning those five areas. However, the scope of information addendum at least minimally refers to those areas as part of the review process. The flow chart/scope of service information addresses the four state-required indicators. The other six indicators required in the application are listed as “to be determined by the [Quality Management] committee.” Wolfson points out that in the minutes from a QMC meeting in February (which was included in the application), nine additional indicators are listed. So, although not easily found, the application does provide sufficient response to the required element. The application is also supposed to identify cases relevant to the six selected indicators in order to determine whether any of those cases should be referred to the QMC. The determination to refer cases is followed up by an evaluation of the effectiveness of actions taken by the committee. The flow chart can be interpreted to address this requirement, but it is fairly nebulous. The scope of services information provides some additional support, but only in general terms. The required quarterly reports are supposed to show which cases have been selected for corrective action by the committee. Wolfson asserts that it cannot submit any such reports until it is operating as a pediatric trauma center, i.e., until it actually has patient cases to report. That position is plausible. The Department did not provide any evidence as to how other applicants satisfied this requirement, so Wolfson’s position cannot be measured against other providers.1/ The same is true as to the requirement for an in- hospital registry of information concerning patients who are being treated. Wolfson has purchased the software needed to commence its registry once patients are being admitted, but it cannot do so at this time, again because it has no such patients. All things considered, Wolfson’s application was not a superlative response to the question of its abilities, but it at least minimally met the requirements for approval of a provisional license. Considering, de novo, all of the evidence concerning Wolfson’s proposed trauma center operations, the application is complete. Wolfson provided extensive testimony and evidence as to the need for a pediatric trauma center in the service area and its willingness and ability to meet that need. There is no doubt that, if approved, the pediatric trauma center would be beneficial to the area. However, need was not an issue in the proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent, Department of Health, enter a Final Order approving the pediatric trauma center application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital. DONE AND ENTERED this 14th day of November, 2017, in Tallahassee, Leon County, Florida. S 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 14th day of November, 2017.
