Findings Of Fact Surgicare III is the sponsor of Surgicare Outpatient Center of Leesburg, a proposed freestanding ambulatory surgical center to be located in Leesburg, Florida. LRMC is an existing hospital located in Leesburg. It has four operating rooms where general surgery is performed and one cystoscopy room. Lake is an existing hospital located in Leesburg, Florida. It has three operating rooms and one cystoscopy room. Two additional operating rooms are presently under construction, one of which is intended to be used for minor surgeries under local anesthesia. Waterman is an existing hospital located in Eustis, Florida. It has four operating rooms, one urology procedures room, and one endoscopy room. Waterman has a certificate of need to add two additional operating rooms As originally proposed Surgicare's application was to construct a one- story building containing 10,000 square feet and two operating rooms. The original plans have been amended to reduce the size of the building to 8,000 square feet. The total cost as projected will not exceed $1,570,064. The service area proposed to be served by this facility includes Lake County and a 30-minute driving radius, approximately 20 miles, from Leesburg. Surgeries proposed at this facility are those surgeries, performed under general or local anesthesia, after which the patient will be able to be taken home and cared for, rather than remain overnight or longer in the hospital. Most such surgeries are elective as contrasted to emergency. Surgicare projects a total of 1 ,269 procedures in the first year and 2, 011 in the second year of operation. Based on construction costs or the original 10,000 square foot building, with permanent financing at 12 percent and these numbers of procedures, at an average cost of $390 per procedure the first year and $413 per procedure the second year, the facility will show a slight profit in the second year. The presently proposed facility containing ,090 square feet will be less costly than the 10,000 square foot facility and, even if interest is higher than the estimated 12 percent, Petitioner will be able to pass the break-even point during the second year of operation, if necessary by increasing fees. The average charge for similar surgeries in the Lake County hospitals is $1,309, so a slight increase by Petitioner, if necessary, is acceptable. There is currently no rule establishing the methodology to be used in determining need for an ambulatory surgical center. Nor is there a local health system plan applicable to such need. IRS uses a pro-competitive methodology which is based upon a policy which has not been adopted as a formal rule. This methodology uses the total reported surgery cases in a given county for the most recent 12-month period, the population estimate for the period, and derives a surgical utilization rate per 1,000 population. Similarly, the reported number of outpatient procedures in that county for the same period is used to derive the outpatient surgical use rate. Applying the outpatient use rate to projected future population, HRS then determines the number of outpatient procedures expected in future years in that service area. In evaluating ambulatory surgery center CON applications, HRS utilizes a two-year planning horizon. Surgicare is expected to complete its second year of operation in 1988, so 1988 becomes the relevant year For looking at projected need. Since December, 1982, HRS has assumed that 29 percent of all surgeries could be performed in an outpatient setting. This 29 percent target is the mean between 18 percent (the actual percentage of total surgeries which are reported to have been performed on an outpatient basis by hospitals participating in a 1981 survey by the American Hospital Association) and 40 percent (that percentage which a survey of literature relating to ambulatory surgeries projected could be performed in outpatient settings) . The outpatient surgeries performed in Lake County hospitals during the most recent reported 12-month period was well below the 18 percent average nationwide. This 29 percent target is a reasonable estimate of the percentage of surgeries that can be performed on an outpatient basis. In the past two years, as is shown by the testimony presented at this hearing, hospitals in Lake County have become more receptive to facilitating outpatient surgeries on their premises. This would have the effect of increasing the 18 percent found in 1981, if a survey similar to the 1981 survey was taken today. A more recent report of the American Medical Association indicates that this low end of the range has, in fact, risen to 20.0 percent. Accordingly, a mean of 30.4 percent of all surgeries performed on an outpatient basis is reasonable. By applying the target factor to projected total surgeries, HRS calculates the projected number of potential ambulatory surgeries for a given year in the future. Subtracting the outpatient surgeries projected to be performed in existing facilities in the future from the total potential outpatient surgeries yields a projected unmet need for outpatient surgical care. Applying the 29 percent factor to the surgeries performed in Lake County for the last 12 months reporting period and projecting this figure to 1988, HRS projects a potential need for outpatient surgeries in Lake County at 3,090. Based on the 1983 reported outpatient surgical use rate for Lake County and a target of 29 percent, 1,455 of the 3,090 surgeries would be performed in hospital settings in 1988 leaving an unmet need of 1,635 potential outpatient surgeries to be performed in Lake County. The intervening hospitals all contend that they have adequate capacity in their existing operating rooms to provide for all needed outpatient surgery in Lake Count and there will be excess capacity when the four additional approved operating rooms become operational. However, none of these existing or to be added operating rooms is dedicated to outpatient use although Lake will open in the near future an operating room in which only minor surgery under local anesthesia will be performed. Until very recently the Lake County hospitals were charging outpatient surgery patients the same charges imposed on inpatient surgery patients, except for the overnight room charge. As a result the average charge for outpatient surgery per procedure in Lake County is $1,309. Petitioner's initial proposed average charge per procedure is less than $400. Recently one or more of the Lake County hospitals have offered a flat charge for use of their facilities for minor surgeries. However, these new charges greatly exceed the charges proposed by petitioner. Many of the surgical procedures performed in hospitals are classified as emergency and take precedence in the use of operating rooms ever elective surgical procedures which most outpatient surgeries are classified. As a result it is difficult for doctors to schedule outpatient surgeries in hospital operating rooms and have those schedules met. An exception would be, of course, if the doctor reserved and kept the operating room in which he scheduled the first operation that day. The facilities now provided to patients undergoing outpatient surgery at LRMC is not well suited to outpatient surgery because outpatient surgery patients go from the operating room to the post anesthesia recovery area whether they had local or generate anesthesia. This same space is used as a postoperative recovery area for all surgical patients, some of whom have undergone serious and extensive surgery. These are not pleasant surroundings for patients following their minor surgery. LMRC outpatient surgical facilities are as good or better than those in the other Lake County hospitals. Even if the existing and approved operating rooms available in Lake County hospitals are adequate, as shared outpatient-inpatient facilities, to provide for the outpatient surgeries needed in 1989, this does not preclude the need for the proposed facilities as a competitive factor in reducing hospital costs. None of the existing, and authorized, operating rooms in Lake County are dedicated for outpatient surgery, and according to federal regulations none can be so dedicated as presently organized. Medicare has recognized the cost saving aspects of ambulatory surgical facilities by paying 100 percent of the cost of surgeries performed at dedicated outpatient surgical facilities on Medicare patients while paying only 80 percent of the cost of surgeries performed at non- dedicated facilities. At present there are no freestanding ambulatory surgical facilities in Lake County. Only freestanding facilities can be dedicated and thereby receive from Medicare 100 percent of the charge for outpatient surgery. Accordingly, this will be the only facility in Lake County capable of offering this service to the residents of Lake County. Since their rates are lower than the reimbursement Medicare would pay to Lake County hospitals for the outpatient surgery performed at these facilities, use of dedicated outpatient surgical facilities will reduce the cost of health care. The filing of the application in this case induced the Lake County hospitals to speed up the review of their outpatient surgical procedures to provide better and less costly service. Without competition in outpatient surgical procedures, the hospitals have no incentive to institute cost-cutting measures apart from the measures they may have to adopt as a result of the newly implemented diagnostic related groupings (DRG) by the federal government. However, the DRGs are primarily aimed at reducing length of hospital stays and eliminating unnecessary diagnostic procedures, rather than directly reducing surgical costs.
The Issue Whether Respondent violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and, if so, what discipline should be imposed.
Findings Of Fact The Department is charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2003). Dr. Dangl, whose address of record is 3900 Clark Road, Suite F-1, Sarasota, Florida 34233, was issued Florida license number ME 71286. On or before September 25, 2003, Dr. Dangl's office was approved to perform Level II Office surgical procedures by the Department. In a Level II Office surgery, "the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation." Fla. Admin. Code R. 648-9.009(4). Patient J.R., a 38-year-old female, presented to Dr. Dangl on September 25, 2003, for the removal of existing breast implants and the placement of larger saline implants. The surgery was scheduled to take place in Dr. Dangl's office. The surgical team consisted of Dr. Dangl; Amanda Fortner, R.N.; and Bruce Crow. Ms. Fortner assisted Dr. Dangl in administering anesthetic agents and other controlled substances, and monitored J.R. during the procedure. Her duties included documenting J.R.'s vital signs and the types and quantities of medications that were administered. A cardiac respiratory monitor, a pulse oximeter, and a blood pressure monitor were devices used to monitor J.R. during the surgery. A cardiac respiratory monitor records the heart rate, respirations, and the sinus rhythm of the heart. The oxygen saturation in the blood is measured by the pulse oximeter, which is placed on one of the patient's fingers. Blood pressure is monitored by the blood pressure machine. Bruce Crow was the surgical technician. During the surgical procedure, he made sure supplies and surgical instruments were ready, maintained the sterile field, and assisted Dr. Dangl with the procedure. At approximately 9:15 a.m. on September 25, 2003, Dr. Dangl started an IV in J.R.'s left hand and administered the following medications: one gram of Rocephin, 20 milligrams of Reglan, 50 milligrams of Demerol, ten milligrams of Valium, 25 milligrams of Ketamine and Versed. Dr. Dangl gave the initial medications, and Ms. Fortner administered additional drugs pursuant to Dr. Dangl's orders. J.R. was given an additional 200 milligrams of Demerol. The last dose of Demerol was administered by Ms. Fortner at 9:50 a.m. J.R. was a small person, and, for her weight and size, it took an unusual amount of Demerol to get J.R. sedated. Versed and Valium are sedative hypnotics, which sedate patients and cause them to become sleepy. Demerol is an analgesic, a pain medication. These medications can decrease respiration. Ketamine is a dissociate anesthetic, which does not cause respiratory depression. J.R. was also given a Propofol drip IV to help keep J.R. asleep. Propofol is a general anesthetic which depresses brain cells. The Propofol was mixed with a saline solution at a rate of one 55 cc vial per 100 cc's of saline. Ms. Fortner prepared the solution, which was initially administered by Dr. Dangl until he got it to the rate that he wanted. Once the surgery started, he would tell Ms. Fortner to speed-up or slow- down the drip as necessary. Three bottles of Propofol were used during the surgical procedure. J.R. was also given two liters of oxygen during the procedure. An oral airway was inserted into J.R.'s mouth during the early stages of the procedure. An oral airway is a long device that is inserted behind the tongue and goes deep into the patient's throat. In order to tolerate an oral airway, the patient would have to be in a deep level of sedation. J.R. was awake when the medications were started. She continued to talk through at least half of the time the medications were being administered. At one point during the surgery, J.R. "moaned a little bit, but then went right back to sleep." During the surgical procedure, Dr. Dangl sat J.R. up approximately three times to check the symmetry of the implants. J.R. continued to sleep through these checks. During the last time that J.R. was brought to a sitting position at approximately 11:55 a.m., the pulse oximeter alarmed. Thinking that the device may have fallen off J.R.'s finger, Ms. Fortner checked the device and also checked to make sure that the oximeter was not on the arm on which the blood pressure machine was placed. The pulse oximeter was on the correct finger. Ms. Fortner advised Dr. Dangl that something was wrong. She turned up the oxygen and placed an Ambu bag1 over the oral airway which had been placed in J.R.'s mouth at the beginning of the case. Ms. Fortner started Ambu bagging J.R. At Dr. Dangl's direction, Ms. Fortner turned off the Propofol drip. However, J.R.'s pulse oximeter reading did not improve. Not wanting to break the sterile field, Dr. Dangl yelled at Ms. Fortner, "Don't make me come back there and help your ass." When J.R. still did not improve, Dr. Dangl broke the sterile field, pushed Ms. Fortner aside, and began to Ambu bag J.R. Dr. Dangl checked J.R. for a pulse, but was unable to find one. Ms. Fortner checked for a pulse and thought that she may have found a faint pulse. Dr. Dangl, hearing the receptionist in the hallway, called to her to get Michelle Purdy, another employee of Dr. Dangl. The receptionist went to get Ms. Purdy and came back saying that Ms. Purdy was on the telephone. Dr. Dangl told the receptionist to get Ms. Purdy. Ms. Purdy, who is not a nurse, came into the operating area and tried to find a pulse for J.R. Unfortunately, Ms. Purdy tried to find a pulse using her thumbs. After being corrected by the surgical team, Ms. Purdy attempted to locate a pulse in the brachial, then the femoral, and then the pedal pulses, but she was unable to find a pulse. After being unable to locate a pulse, Dr. Dangl instructed one of his staff to call for emergency medical services (EMS). While Dr. Dangl and his employees were searching for a pulse, the surgical technician asked for leave to begin chest compressions. Mr. Crow told Dr. Dangl that the heart rate monitor was flat lining, meaning that it showed no basic heart rhythm for J.R. J.R.'s skin was gray and her fingers were turning blue. Dr. Dangl told Mr. Crow to wait. Dr. Dangl instructed Ms. Fortner to give J.R. three milligrams of Atropine two times. Ms. Fortner complied with his orders, but J.R. still had not started to breathe again. Mr. Crow continued to request Dr. Dangl to allow him to start chest compressions. After the administration of the Atropine failed to revive J.R., Dr. Dangl allowed Mr. Crow to begin chest compressions. From a minimum of two minutes to a maximum six minutes2 elapsed between the time Mr. Crow first asked to do chest compressions and when he began to do chest compressions. While chest compressions were being administered, Dr. Dangl ordered Ms. Fortner to administer Epinephrine to J.R. While Dr. Dangl continued to Ambu bag J.R., Mr. Crow administered three cycles of chest compressions. A cycle is 15 chest compressions to two Ambu breaths. J.R.'s heart rate returned and J.R. developed tachycardia, which means a high heart rate. About the time that J.R. revived and became stable, the paramedics arrived. J.R. was breathing, had a heart rate, and had a pulse oximeter reading of approximately 98. Neither the paramedics nor Dr. Dangl or any of his staff checked J.R.'s pupils. When the paramedics arrived, the surgery was not completed. The paramedics informed Dr. Dangl that another EMS team was on the way. Dr. Dangl and the paramedics agreed that Dr. Dangl could finish closing and suturing the wound, while waiting for the other EMS team to come and transport J.R. to the hospital. The paramedics stayed for a short time in the operating area monitoring J.R.'s vital signs and then left to make copies of J.R.'s chart, leaving Ms. Fortner to continue the monitoring of the vital signs. While Dr. Dangl was completing the procedure, J.R.'s vital signs were within normal range. Ms. Fortner periodically checked J.R.'s breathing by placing her hand over J.R.'s mouth. After Dr. Dangl completed suturing the wound, the second team of paramedics came into the operating area to transport J.R. The paramedics examined J.R.'s eyes, which were fixed and dilated. The paramedics immediately intubated J.R. and took her to the hospital. While at the hospital, Dr. Dangl admitted to J.R.'s fiancée that he had given J.R. "a lot of medication for her body size and weight," but that he thought J.R. was metabolizing the anesthetic very quickly. J.R. never regained consciousness after she was transported to the hospital. She died several months later from hypoxic encephalopathy, which means low oxygen brain damage. On September 26, 2003, Dr. Dangl dictated a report of operation. His documentation of J.R.'s "cardiorespiratory event" is as follows: Immediately prior to closure, the patient experienced a cardiorespiratory event that required CPR and resuscitative efforts. The EMS was activated and assumed care of the patient upon arrival. At this time the patient had responded to the resuscitative effort, vital signs were stable and permission was given by EMS to complete closure of the incisions prior to transport. The incisions were closed in a layered fashion with 3-0 PDS II and 5-0 nylon. A sterile dressing was placed over the incision sites. The patient was entubated [sic] by EMS prior to transport and left the O.R. via ambulance for Doctor's Hospital Emergency Room. Dr. Dangl signed a document entitled, "Operating Room Record." The record contained a section in which the medications that were administered should have been listed along with the time administered, the dosage, and the method of administration. That section of the record contained the following, "see anesthesia record," in lieu of listing the medications. The anesthesia record which was prepared by Ms. Fortner did not list all the medications that were administered to J.R. such as the Atropine and Epinephrine. She did not list the amount of Lidocaine or Propofol that was administered. It should have been obvious to Dr. Dangl when he reviewed the anesthesia report, that it was not correct. When Dr. Dangl prepared the Report of Operation and signed the Operating Room Record, he should have included the medications which he ordered and which were not included in the anesthesia report. Both Dr. Dangl and Ms. Fortner were certified in Advanced Cardiac Life Support at the time of the surgery. Ms. Fortner is not an anesthesiologist, a certified registered nurse anesthetist, or a physician assistant. Based on the testimony of Ms. Fortner that three 50 cc bottles of Propofol were used during the surgery, Dr. Joan Christie calculated that the dosage of Propofol that was administered was between 160 and 170 micrograms per kilo per minute. In a normal patient, who has received no other drugs, 100 micrograms per kilo per minute would be a lot of medication. J.R. received between 160 and 170 micrograms per kilo per minute on top of the other drugs that had been administered to her at the beginning of the procedure. The Propofol was administered in excessive amounts. Based on the evidence presented, it is clear that J.R. went from a Level II to a Level III office surgery during the surgical procedure. She tolerated an oral airway, which she could not do under a Level II or Level I. She was not responding purposefully to verbal commands or tactile stimulation. When J.R. was sat up to check the symmetry of her implants, she did not wake up or otherwise respond. Although she did moan at one time during the surgical procedure, that did not mean that she was either at Level I or Level II. Dr. Dangl has had no prior disciplinary actions taken against him by the Department.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and revoking his license to practice medicine. DONE AND ENTERED this 23rd day of February, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 23rd day of February, 2005.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I hereby make the following Findings of Fact: Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0040343. On the morning of October 7, 198A, the Metro-Dade County Rescue Squad called the emergency room at Miami General Hospital and informed the staff that they were enroute to the hospital with a gunshot victim. Dr. Segurola, the emergency room physician, was informed of the victim's condition and immediately ordered a nurse to notify the operating room team and call a surgeon because he knew in advance that "this was going to be a serious surgical case." At approximately 7:42 a.m., the rescue squad arrived at Miami General Hospital with the victim, Samuel Kaplan. Kaplan was taken to the emergency room suffering from a gunshot wound to the abdomen inflicted by a .32 caliber bullet. When Kaplan arrived in the emergency room, his systolic blood pressure was approximately 60, he was wearing a MAST suit, he had an intravenous (IV) line going, and he was receiving oxygen. Although Kaplan was conscious and able to speak, his condition was unstable and very serious. Kaplan was initially treated by Dr. Segurola, the emergency room physician. Three nurses, a respiratory therapist and an x-ray technician were also present in the emergency room. Dr. Segurola conducted a brief physical examination of Kaplan. An entrance wound was found, but there was no exit. After the examination, a second IV line was started in the other arm and a third, central line was started in the subclavin vein. The IV lines were set at maximum or "wide open." The emergency room staff was attempting to rapidly increase Kaplan's blood volume and pressure. Kaplan's hemoglobin level was low (approximately 8 or 9), which is a sign that a patient is anemic due to loss of blood. At approximately 8:00 a.m., Respondent received a message from his telephone answering service to call Dr. Segurola at the hospital's emergency room. At approximately 8:02 a.m., the Respondent returied the telephone call and spoke with Dr. Segurola concerning the patient's condition. During the conversation, the Respondent advised Dr. Segurola to contact the operating room team and anesthesiologist to prepare for surgery. The Respondent arrived at the emergency room of Miami General Hospital in response to the call at approximately 8:12 a.m. Upon the Respondent's arrival at the emergency room, he was informed that Kaplan's blood pressure was 108/50, heart rate 106 and respiration 28. The Respondent spoke to Kaplan and Kaplan stated that he had been shot in the stomach. Respondent then proceeded to conduct a brief, but thorough, physical examination of the patient. When Respondent completed his examination, he was advised that Kaplan's blood pressure was approximately 124/50, heart rate remained at 106 and respiration remained at 28. At this point, the Respondent believed that Kaplan's condition was stabilized. Respondent advised Dr. Segurola that Kaplan should immediately be taken to the operating room for surgery. The Respondent was informed that the operating room was not quite ready and that the anesthesiologist had not arrived. While waiting for the operating room team, Respondent and Dr. Segurola reviewed x-rays of Kaplan. The emergency room nurse continued to take Kaplan's vital signs. Kaplan's blood pressure remained at 124/50. At approximately 8:20 a.m., while Respondent, Dr. Segurola and others in the emergency room were waiting for confirmation that the operating room was ready, a hospital admissions clerk walked in and informed the emergency room staff that Kaplan belonged to the Health Maintenance Organization ("HMO"). An HMO is a plan in which a patient makes pre-payment for services and is then provided medical services from a designated panel of participating physicians. The emergency room maintained two "on-call" lists, one for HMO surgeons and one for non-HMO surgeons. The Respondent was on the non-HMO list. Dr. Segurola and Respondent had a brief discussion wherein both men acknowledged that under existing hospital policy, the HMO surgeon should have been called. Thereafter, Dr. Segurola informed a nurse to telephone the on-call HMO surgeon. The HMO surgeon on call was Dr. Moises Jacobs. A secretary in the emergency room placed a call to Dr. Jacobs at approximately 8:25 a.m. Dr. Jacobs returned the phone call between 8:25 a.m. and 8:30 a.m. Dr. Jacobs spoke with Dr. Segurola. While Dr. Segurola was on the phone, Dr. Jose Selem, the anesthesiologist, arrived in the emergency room. Dr. Jacobs told Dr. Segurola to ask the Respondent to take the patient to surgery immediately and stated that he would arrive at the hospital in about 20- 30 minutes. When the Respondent was told of Dr. Jacobs' request he replied that the patient was stable and could wait for Dr. Jacobs. Dr. Selem, the anesthesiologist, also spoke with Dr. Jacobs on the telephone. Dr. Jacobs told Dr. Selem to advise Respondent that Respondent could take the patient to surgery. When Dr. Selem advised Respondent of what Dr. Jacobs has said, the Respondent replied that since Dr. Jacobs was coming to the hospital and Kaplan was an HMO patient, Respondent preferred to wait for Dr. Jacobs, the HMO surgeon. Dr. Selem then left the emergency room and went to the operating room to prepare the necessary instruments. At approximately 8:30 a.m., the Respondent advised Dr. Segurola that he was going to the hospital cafeteria for a cup of coffee and, if any changes occurred in the patient, he should be contacted. The cafeteria was located across a corridor approximately 20-25 feet from the emergency room. At the time, Kaplan was still alert and his vital signs were being constantly monitored by the nursing staff. Dr. Segurola remained in the emergency room. The operating room and all necessary personnel were ready for surgery at approximately 8:40 a.m. Sometime between 8:40 a.m. and 8:45 a.m., one of the nurses told Dr. Segurola that the Respondent's condition was deteriorating and that his blood pressure was dropping. At approximately 8:45 a.m., Kaplan's blood pressure had dropped to 80/50. Dr. Segurola told the nurse to give more blood to Kaplan (a blood transfusion had already been started). Dr. Segurola then went to the cafeteria to speak with Respondent. Dr. Segurola told Respondent that the patient's condition was deteriorating, a blood transfusion had been started, and he feared that Kaplan might die in the emergency room. The Respondent inquired as to how long it had been since Dr. Jacobs had been called and Dr. Segurola responded twenty (20) minutes. Respondent questioned whether it really had been 20 minutes. Both men looked at their watches and determined that it had been about 15 minutes since Dr. Jacobs had been called. Respondent told Dr. Segurola to call the anesthesiologist. Dr. Segurola went back to the emergency room, believing that Respondent was going to immediately follow him there. When Dr. Segurola arrived back at the emergency room, Kaplan's condition had not improved. Dr. Segurola waited about three (3) more minutes and went back to the cafeteria for the second time. Dr. Segurola again informed the Respondent about Kaplan's deteriorated condition and his fear that Kaplan was going to die in the emergency room. Respondent once more asked Dr. Segurola to call the anesthesiologist. Dr. Segurola told Respondent that the anesthesiologist was there and that "we need you there." Dr. Segurola then went back to the emergency room. The Respondent remained in the cafeteria. Shortly before 9:00 a.m., while Dr. Segurola was away from the emergency room, Dr. Lustgarten, a neurologist, had just finished his rounds and was leaving the hospital through the emergency room to the parking lot. Dr. Lustgarten looked in on Kaplan to determine if there was any neurological damage. Dr. Lustgarten examined Kaplan and concluded that there was no neurological damage and that, in his opinion, Kaplan's condition was stable with a systolic blood pressure of approximately 100. Dr. Lustgarten left the emergency room just as Dr. Jacobs arrived at approximately 9:00 a.m. Dr. Lustgarten told Dr. Jacobs that Kaplan had no neurological damage. Dr. Jacobs conducted a brief examination of Kaplan and determined that Kaplan needed to be taken to the operating room immediately for surgery. The anesthesiologist, Dr. Selem, had by then been summoned to the emergency room and assisted Dr. Jacobs in an unsuccessful attempt to intubate Kaplan prior to taking him to the operating room. Shortly after Dr. Jacobs arrived, the Respondent left the cafeteria and headed towards the emergency room. Before Respondent reached the entrance to the emergency room, he was informed by one of the nurses that Dr. Jacobs had arrived. The Respondent stood at the entrance to the emergency room for a brief period and watched as Dr. Jacobs and others attended to Kaplan. Respondent then left the building, went to his car and drove home. Meanwhile, Dr. Jacobs performed an emergency exploratory laparotomy and left thoracotomy on Kaplan. Between 9:00 am. and 9:15 a.m., after Kaplan was moved from the emergency room to the operating room, his blood pressure went from 90 down to 60, and he went into shock. There are three possible contributing factors for Kaplan's going into shock at this time: (1) moving him may have dislodged ,a blood clot which in all likelihood prevented an earlier complete "bleeding out"; (2) the blood clot may have been diluted by the IV fluid; and (3) the institution of anesthesia. During surgery it was discovered that the bullet had perforated the aorta, a major blood vessel. While still in surgery, Kaplan went into cardiac arrest and was pronounced dead at 10:25 a.m. on October 7, 1984. At the time that Respondent left the emergency room and went to the hospital cafeteria, Kaplan's vital signs were in a relatively stable condition. Kaplan's vital signs de-stabilized while Respondent was in the hospital cafeteria, and his systolic blood pressure dropped from approximately 120 to approximately 80. At all times prior to being taken to the operating room, Kaplan's vital signs were maintained with the assistance of a MAST suit. A MAST suit is an inflatable device used in the treatment of trauma patients which applies pressure to the body and assists in elevating blood pressure. When the MAST suit is removed, the patient's vital signs will deteriorate again. For this reason, many physicians consider vital signs obtained under such conditions to be false readings, and the MAST suit is usually not removed until the patient is in the operating room. Although the Respondent suspected that the bullet might have damaged the small bowels and caused some internal bleeding, the Respondent neglected to ask about the amount of fluids Kaplan had received. Kaplan had received over 4 to 5 liters of fluid prior to arriving at the hospital and received an additional 5 liters of fluid while waiting to be taken to surgery. Although this information would have been useful, it would not necessarily have indicated the extent of Kaplan's massive internal bleeding. The amount of fluids that Kaplan received prior to the Respondent leaving the emergency room was not necessarily a sign that Kaplan's condition was unstable. In the treatment of trauma cases, time is of the essence. A trauma patient with a gunshot-wound to the abdomen should be taken to surgery as soon as possible. In some cases, it may be advantageous to delay surgery in order to stabilize the patient's vital signs or to increase blood volume. Generally, if surgery is performed within the first hour after the injury is sustained (referred to as "the golden hour"), the better the chances of the patient surviving. The golden hour does not apply to injuries of the heart and major blood vessels. In those cases, the patients will "bleed out" in a time much shorter than one hour. Nevertheless, even where the golden hour has passed, the patient should be taken to surgery at the first available opportunity and without delay. While in the emergency room at Miami General Hospital, Kaplan's condition ranged from "serious" to "critical." From the time that Kaplan was initially admitted to Miami General Hospital his condition was such that he required immediate surgical intervention. A reasonably prudent physician in the Respondent's position would have performed surgery at the first available opportunity and would not have waited for the arrival of another surgeon. Although pursuant to hospital and HMO rules, the HMO surgeon should have been called first, where an emergency situation exists the first surgeon available is expected to take the patient to surgery, and that physician will be provided payment by the HMO. The Respondent was aware of the hospital's and HMO's policies regarding HMO and non-HMO patients based on prior experience. The Respondent has never previously been disciplined or investigated by Petitioner or any medical board in any jurisdiction. Respondent maintains an excellent reputation for competence and compassion among his fellow physicians. Respondent is well liked by his patients and has provided medical services in the past to patients with no medical insurance.
The Issue Whether Respondent's license to practice medicine in the state of Florida should be revoked, suspended or otherwise disciplined.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all time relevant to this proceeding, the Respondent was licensed to practice medicine in the state of Florida, having been issued license number 0024212. Respondent is also licensed to practice medicine in the states of Pennsylvania, New York, New Jersey and Illinois. Respondent is an anesthesiologist who was board certified in 1962, and has had experience as a professor of anesthesiology. The two cases involving patients L. Y. and O. G. that are in issue in this proceeding arose while Respondent was practicing at Manatee Memorial Hospital in Bradenton, Florida. It is the recovery room nurse's responsibility to fill out the post anesthesia care unit (PACU) record which documents the patient's course through the recovery room. The record includes notations which track the patient's activity, respiration, blood pressure, consciousness and color. Each category is scored on the basis of 0, 1 or 2. Each individual score is determined by the recovery nurse's observation of the patient and her judgment of the patient's condition at that particular moment. Ambu-bagging is a procedure whereby a mask with a reservoir bag of oxygen is placed over the nose and mouth of the patient and the bag is squeezed to force air and oxygen into the lungs of patient. Ambu-bagging is used in situations where the patient is not breathing and the procedure, in effect, breathes for the patient. PATIENT, L. Y. L. Y., a 72 year-old female who presented with abdominal pain and was initially evaluated in the emergency room of Manatee Memorial Hospital on March 22, 1988. The emergency room physician, James A. DeRespino, M. D., diagnosed the patient's condition on admission as abdominal pain/rule out perforated viscus. Jose Estigarriba, M. D., the physician called in for consultation on March 23, 1988 by Robert A. Fishco, the attending physician, diagnosed the patient's condition as acute abdomen, peritonitis, possible perforated viscus. L. Y. was in extremely ill health upon her admission. L. Y. had diabetes, chronic high blood pressure, coronary artery disease, recurrent heart failure, congestive heart failure and a history of pulmonary edema. L. Y. was on multiple medications for her diabetes and cardiovascular disease. Both Dr. Estigarribia, the patient's surgeon, and Dr. Fishco felt that immediate surgical intervention was necessary to determine and correct the problem. L. Y. initially refused to have the surgery for approximately 24 hours. However, after talking with Dr. Fishco the patient finally consented to surgery late in the afternoon of March 23, 1988, approximately 24 hours after admission to the hospital. After the patient consented to surgery, Dr. Estigarribia immediately discussed with the patient the various invasive monitoring techniques and retaining the patient on a respirator after surgery. The patient refused these procedures because of difficulties she had experienced during similar procedures in the recent past. At this point, Dr. Estigarribia determined that it was best to move the patient to surgery as quickly as possible and dispense with such devices as swan-ganz catheters because he was concerned that she may change her mind and decide against surgery. The Respondent was first notified of the surgery approximately fifteen minutes prior to L. Y. being transported to the operating room. Respondent saw the patient in the operating room and took a history. Dr. Estigarribia informed the Respondent of the urgent situation and of the patient's refusal to consent to ventilation therapy and invasive monitoring. Respondent anesthetized the patient using a rapid sequence induction. Dr. Estigarribia then performed an exploratory laparotomy, resection of the small bowel, end-to-end anastomosis, and peritoneal lavage on the patient. After the surgery was completed but prior to the patient being extubated, Respondent checked the patient's blood pressure (120/70) and pulse rate (90), found the patient's color to be good and her oximetry (oxygen saturation of blood) readings to be satisfactory. Just prior to extubation, the patient's blood pressure was 140 over 90, her pulse rate 90, her oximetry reading was 96, she was breathing on her own and was conscious to the point of being able to communicate with Respondent by opening her eyes when asked a question. After making certain that the patient was breathing on her own and was conscious, Respondent extubated the patient while still in the operating room. Shortly thereafter, approximately 10 minutes, the patient was moved to the recovery room. The patient progressed satisfactorily in the recovery room. The patient's PACU score upon arrival in the recovery room at 10:30 p.m. was 5 out of a possible 10, with consciousness and activity each being given a score 0 by the recovery room nurse and respiration a score of 1. However, within 10 minutes the patient had improved to a total score of 9, with a consciousness and activity each being given a score of 2 and the respiration score remaining at 1. The total score remained at 9 until 12 midnight, approximately one and one-half hours after the patient was delivered to the recovery room. At 12:30 a.m., approximately two hours after her admission to the recovery room, the patient's score dropped to a total of 4 and the patient experienced ventricle fibrillation and expired as a result of this cardiac event at approximately 12:47 a.m. There is competent substantial evidence in the record to establish facts to show that Respondent's treatment of patient, L. Y. was within that level of care, skill, and treatment recognized as being acceptable under similar conditions and circumstances at the time of extubation and subsequent recovery room care, notwithstanding the testimony of Dr. Monroe and Dr. Kruse to the contrary which was based primarily on the hospital's records and more specifically on the recovery room nurse's scores and notes in the PACU records. PATIENT, O. G. Patient, O. G., is a sixteen year old male athlete who sustained a fractured mandible in an athletic event. O. G. was admitted as an emergency case to the Manatee Memorial Hospital on June 9, 1988 with a diagnosis of acute fracture of the mandible and laceration of the mouth. On June 9, 1988 the patient's attending surgeon performed an open reduction of the right angle of the mandible and the removal of four impacted wisdom teeth. Respondent placed the patient under general anesthesia for the above scheduled procedure. When the operative procedure ended (at approximately 6:55 p.m.), Respondent remained in the operating room with the patient approximately 30 minutes to assess the patient's post-operative condition. While still in the operating room the patient exhibited the usual indicators for extubation. The patient's oximetry readings were good, his blood pressure and pulse were good, he was breathing on his own with adequate title volume, he responded when given verbal commands, and was able to lift his head. At this point in time, the patient was having adverse reaction to the tube used by Respondent to maintain the patient's airway. Based on his training and experience as an anesthesiologist, using the above indicators, the Respondent determined that the patient was ready to be extubated. The patient was extubated in the operating room by the Respondent before being transferred to the recovery room. Upon being delivered to the recovery room, at approximately 7:25 p.m., the patient's condition began to deteriorate. The patient's breathing became shallow and he did not respond to verbal commands. The Respondent had the recovery room nurse remove the blanket covering the patient so that the Respondent could observe the patient's respiratory pattern and coloration to determine if the patient needed assistance with breathing and to give assistance, if needed. The Respondent had the nurse place the patient on 100% oxygen. Normally, a patient is placed on 40% oxygen. The patient did not recover from the anesthesia as quickly as the Respondent had anticipated. Notwithstanding the recovery room nurse's testimony as to her observation of the patient's condition as set out in the PACU records, the patient's condition was not so life threatening as to require intervention by the Respondent prior to the time he decided to call in a pulmonologist. While I do not doubt the competence of the recovery room nurse, the Respondent's testimony that his observation of the patient's condition during this period of time led him to believe that it was not life threatening was more credible. It was the Respondent's observation of the patient's condition that guided him in choosing a conservative procedure in his handling of the patient. Although Respondent was assisting with other operations in the hospital during this time, he stayed within voice range of the patient and nurse, monitoring the patient's condition and periodically assisting or having the nurse assist the patient in breathing by using an Ambu-bag and when necessary, either the Respondent or the nurse, would suction off blood secretions through the nasal passage. The Respondent chose this conservative procedure of monitoring the patient's condition rather than performing a "blind" intubation through the nasal passage or by cutting the wires holding the patient's jaws shut and intubating through the mouth thinking the patient would respond without the necessity of reintubation. The first procedure would have involve the risk of pushing possible blood clots into the lower portion of the patient's airway, while the second procedure would necessitate that the patient undergo an additional operation. Eventually, when O. G. failed to respond, Respondent decided to reintubate the patient. However, since the Respondent had decided against a "blind" intubation through the nasal passage or cutting the wires on the jaws to intubate through the mouth, he decided to intubate using a fiber optic bronchoscope in order to visualize the airway and remove any blood clots that may have formed in the upper portion of the airway as a result of the surgery. This procedure would avoid the risk of pushing the blood clots down into the lower part of the patient's airway. Since Respondent was not a pulmonologist he was not given the privilege at Manatee Memorial Hospital to use a fiber optic bronchoscope. Therefore, Respondent sought the services of David Law, M. D., a pulmonologist on call at the hospital that evening, to perform the reintubation using the fiber optic bronchoscope. Dr. Law reintubated the patient using the fiber optic bronchoscope. Dr. Law found blood clots in the upper portion of the patient's airway which were removed before attempting the reintubation. The patient was then transported to the Intensive Care Unit and afterwards recovered satisfactorily. Dr. Law opined that he would not have attempted a "blind" nasal reintubation of the patient under the circumstances here because of the possibility of pushing blood clots down into the lower portion of the patient's airway. In the medical community a pulmonary physician is the specialist most experienced with the use of a fiber optic bronchoscope, and it would be unusual for a non-pulmonary physician to use a fiber optic bronchoscope under circumstances similar to those occurring with this patient. There is competent substantial evidence in the record to establish facts to show that Respondent's treatment of the patient, O. G. was within that level of care, skill, and treatment recognized as being acceptable under similar conditions and circumstances at the time of extubation and subsequent recovery room care, notwithstanding the testimony of Dr. Monroe and Dr. Kruse to the contrary which was based primarily on the hospital's records and more specifically on the recovery room nurse's scores and notes in the PACU records.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint filed in this case. RECOMMENDED this 15th day of January, 1993, at Tallahassee, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of January, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-0596 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the parties in this case. Petitioner's Proposed Findings of Fact. Proposed findings of fact 1, 3, 4, 5, 6, and 9 are adopted in substance as modified in findings of fact 1, 6, 7, 5, 13, and 16, respectively. Proposed finding of fact 2 is unnecessary. Proposed finding of fact 7 is neither material nor relevant to the conclusion reached in the Recommended Order. Proposed findings of fact 8 and 16 go to the credibility of the expert witnesses and are unnecessary as findings of fact. Proposed findings of fact 10-15 and 17-22 are rejected as not being supported by substantial competent evidence since there is more credible evidence supporting a finding contrary to the findings set forth in these proposed findings of fact. 6. Proposed findings of fact 23, 24-25, 29, 30, 31, 33-35, 39- 42, 39, 40, 41, 42, 43 and 44 are adopted in substance as modified in findings of fact 19, 20, 21, 23, 22, 4, 23, 25 and 5, respectively. Proposed finding of fact 26 although acceptable is unnecessary. Proposed findings of fact 27 and 28 go to the credibility of a witness and while they may be accurate they are unnecessary. 9. Proposed findings of fact 32, 36-38, 45-51, 55-71, 73, 75, 77, 78, 80-82, 84, 85, 88-96 are accepted as the testimony of the recovery nurse and the experts who testified in this case and a reflection of the hospital's records, particularly the PACU records upon which the experts relied in given their testimony or opinions. However, they are not necessarily adopted as findings of fact because the more credible evidence is to the contrary. See findings of fact 22-30. Proposed finding of fact 52 is accepted but unnecessary since it relates to proposed findings of fact 53 and 54 which are rejected as not being supported by competent evidence in the record. See finding of fact 25. Proposed finding of fact 72 is rejected as not being supported by competent substantial evidence in the record. Proposed findings of fact 74, 76, 79 and 83 are adopted in substance as modified in findings of fact 27, 28, 30 and 24-26, respectively. Proposed finding of fact 86-87 are accepted but unnecessary since there was no showing that patient suffered heart failure and pulmonary edema. Proposed findings of fact 97-101, 103 and 104 are more a restatement of testimony than findings of fact but see findings of fact 24-26. Proposed finding of fact 102 deals more with the credibility of a witness but see finding of fact 24. Proposed finding of fact 105 is rejected, see findings of fact 24-26. Respondent's Proposed Findings of Fact. Proposed finding of fact 1 is unnecessary. Proposed findings of fact 2 - 20 and 22 are adopted in substance as modified in findings of fact 1, 2, 1 & 2, 3, 6, 7, 8, 8, 9, 10, 11, 12, 13, 14, 16, IS, 18, 17, 17 and 18, respectively. Proposed finding of fact 21 is more of a discussion of the testimony of Drs. Monroe, Kruse and Kozma rather than being stated as a finding of fact and is therefore, rejected. COPIES FURNISHED: Richard A. Grumberg, Esquire Senior Attorney Department of Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Allen Bobo, Esquire Roger Lutz, Esquire Lutz, Webb, Bobo and Baitty, P. A. One Sarasota Tower Two North Tamiami Trail Sarasota, Florida 34236 Dorothy Faircloth Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
Findings Of Fact Surgicare III is a Florida general partnership comprised of Surgicare Corporation, a wholly owned subsidiary of Medical International, Inc. (MCI) and Surgicare III of Jacksonville, Inc., a Florida corporation. MCI is the nation's largest provider of ambulatory surgical centers operating 34 such centers throughout the United States. MCI will manage the proposed facility under a management contract. The proposed facility will be financed 25 percent equity and 75 percent debt. Petitioner is financially capable of constructing and operating the proposed facility. While Surgicare had not finalized its site selection at the time of the hearing, it proposes to construct the facility in or near Brandon, with the primary service area to comprise Hillsborough County east of U.S. 301. Exhibit 15 is a unilateral prehearing stipulation by Surgicare to construct the facility in the above-described service area if the requested certificate is granted. There are many advantages of outpatient surgery in a freestanding facility over inpatient surgery and over outpatient surgery in an inpatient environment such as an acute-care hospital, of which cost is significant. Without belaboring the issue, it is accepted as a fact that many surgical procedures requiring general anesthesia and taking from a few minutes up to six hours can be performed in an outpatient setting where the patient goes home following the surgery and does not remain in the hospital overnight. Most, if not all, of these outpatient surgeries are elective and freestanding outpatient surgical centers are less costly to the patient, more convenient to the patient and to the surgeon, and provide a better environment for the patient than do most hospital outpatient facilities. Furthermore, the advent of freestanding outpatient surgical facilities has provided competition to hospitals which has resulted in lowering of hospital charges for outpatient surgery. Hillsborough County comprises one service area which includes 13 hospitals and one existing ambulatory surgery center, and a certificate of need has been issued to Surgical Services of Tampa to provide additional outpatient surgical facilities. DHRS has no rule methodology to determine need for additional ambulatory surgical facilities; however, a methodology has been established as a policy under which need for ambulatory surgery centers is determined. This policy has been in effect for an extended period of time; and, with two exceptions, is accepted by Petitioner as the proper method from a health planner's view to determine the need for additional outpatient surgical facilities. These exceptions are the percentage of surgeries expected to be performed in an outpatient setting during the second year of operation of the proposed facility and calculations of need based on a subdivided county. This methodology takes the latest available information for hospitals in the service area as to the number of surgeries, both inpatient and outpatient, performed in each hospital during this latest available period which, in this case, was calendar year 1984. The number of surgeries performed in Hillsborough County divided by the population of Hillsborough County will result in a surgical rate. Since the year in which Petitioner is expected to pass through the break-even point and show a profit is 1989, the population is projected to 1989 and multiplied by the surgical rate to determine the number of surgeries projected for 1989. Those 13 hospitals in 1984 performed 52,482 inpatient surgical procedures and 20,152 outpatient surgical procedures (a total of 72,834) when the Hillsborough County population was 715,435. Using these figures, the surgical rate of Hillsborough County in 1984 is 72,634/715,315 x 1,000 = 101.5 procedures per 1,000 population; the outpatient surgical rate is 24.5 per 1,000; and the Ambulatory Surgery Center is 3.7 per 1,000 (Exhibit 12). With a 1989 population projection of 757,309 in Hillsborough County, the outpatient surgeries performed in hospitals in 1989 will be 24.5 x 787,309/1,000 = 19,289 and Tampa Ambulatory Surgery Center surgeries will be 2,913 (3.7 x 787,309/1,000) or a total of 22,202 outpatient surgeries performed at existing facilities plus an additional 2,222 outpatient procedures to be performed at Surgical Services of Tampa, which will be fully operational at that time. The disputed percentage is the expected percentage of total surgeries which will be performed on an outpatient basis in 1989. Petitioner contends this figure should be 34, while Respondent contends 30 to be the correct percentage. Both parties attempt to extrapolate outpatient surgery percentage provided by the American Hospital Association. In certificate of need hearings involving freestanding ambulatory centers in 1984, DHRS used a figure of 29 percent, which was the mean of 18 percent and 40 percent, the former being the number of outpatient surgical procedures performed in 1981 and the high figure the AMA's estimate of the ultimate percentage of surgical procedures that could be performed in an outpatient setting. Since 1981 the percentage of surgeries performed in an outpatient setting has increased. In 1984 the percentage of total surgeries in Hillsborough County that were performed in an outpatient setting was 27.74 percent. Freestanding outpatient surgical facilities are a recent innovation in the health care provider field. Due to the lower costs associated with outpatient surgical procedures over inpatient surgical procedures, the advent of freestanding outpatient surgical centers has brought much needed competition to the health care provider field and has induced hospitals to provide for outpatient surgery and lower their charges for the use of these facilities. As a result the percentage of surgeries performed in an outpatient setting has grown rapidly in recent years, perhaps at an exponential rate. However, this growth is not unlimited and, as the percentage curves of outpatient surgeries versus total surgeries approaches this limit, the curve flattens. Today nearly all ophthalmic procedures are performed in an outpatient setting; there will be little further percentage growth in that field. Petitioner's contention that outpatient surgeries will increase percentage-wise at the same rapid pace they have increased during the past few years and be at 34 percent in Hillsborough County in 1989 is less credible than is the figure of 30 percent used by Respondent. A proliferation of freestanding outpatient surgical facilities will have the effect of increasing the costs to those patients whose surgery, now done in a doctor's or dentist's office, is shifted to a freestanding outpatient facility. As noted by one of Petitioner's witnesses in these proceedings, his malpractice insurance could be reduced if he performed in an outpatient surgical facility those operations he is currently performing in his office. Obviously, the patient so affected would be charged for the services of an anesthesiologist and other outpatient surgical facility services for which he is not charged when the office surgery is performed. Petitioner further supports the need for this facility by proposing to serve the eastern half of Hillsborough County, which will comprise its service area. Of the 13 hospitals in Hillsborough County, only three are located east of U.S. 301 and none of these has dedicated outpatient operating rooms. There are no official census figures or projections therefrom showing the population of the eastern portion of Hillsborough County in 1984 and DHRS does not so divide Hillsborough County for health care planning purposes. The county is one service area and Petitioner's attempt to subdivide the eastern portion into a sub-area is inconsistent with statewide procedures. Multiplying the surgical rate in Hillsborough County of 101.5 per 1,000 population by the 1989 projected population of 787,309 equals 79,912 surgeries to be performed in 1989. If 30 percent of these are performed in an outpatient setting, the outpatient surgeries will be 23,974. The Hillsborough County hospital outpatient surgeries projected to 1989 are 19,289 and those outpatient surgeries to be performed at Tampa Ambulatory Surgery Center are 2,913. Adding these latter figures results in 22,202 outpatient surgical procedures to be performed in existing facilities. Altogether 2,222 outpatient surgical procedures are projected to be performed at Surgical Services of Tampa. Thus, by 1989 existing and approved facilities will perform 24,424 outpatient procedures and the projected need is 23,974. This results in an excess capacity or negative need of 450 outpatient surgical procedures in Hillsborough County for 1989.
Findings Of Fact At all times relevant hereto Respondent was licensed as a physician in the State of Florida having been issued license number ME0040318. Respondent completed a residency in internal medicine and later was a nephrology fellow at Mayo Clinic. He was recruited to Florida in 1952 by Humana. In 1984 he became associated with a Health Maintenance Organization (HMO) in an administrative position but took over treating patients when the owner became ill. This HMO was affiliated with IMC who assimilated it when the HMO had financial difficulties. At all times relevant hereto Respondent was a salaried employee of IMC and served as Assistant Medical DIRECTOR in charge of the South Pasadena Clinic. 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 a nearby hospital. He was examined 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. When the ambulance with EMS personnel arrived they examined Stroganow, and concluded Stroganow was no worse than earlier when he was transported to the emergency Room, and refused to again take Stroganow to the emergency Room. 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 check on Stroganow. Upon arrival, she was admitted by the landlady and found an 84 year old man who was incontinent, incoherent, and apparently paralyzed from the waist down, with whom she could not engage in conversation to determine his condition. She called for a Cares Unit team to come and evaluate Stroganow. 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 stethoscope, blood pressure cuff, or thermometer, but makes her evaluation on visual examination. Upon arrival of the Cares Unit, and, after examining Stroganow, both members of the team agreed he needed to be placed where he could be attended. A review of his personal effects produced by his landlady revealed his income to be above that 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, Respondent, a physician employed by IMC at the South Pasadena Clinic. The Cares team ruled out ACLF placement because Stroganow was not ambulatory, but felt he needed to be placed in a hospital or nursing home and not left alone with the weekend approaching. To accomplish this, they proceeded to the South Pasadena HMO clinic of IMC to lay the problem on Dr. Dayton, who was in charge of the South Pasadena Clinic, and, they thought, was Stroganow's doctor. Stroganow had been a client of the South Pasadena HMO for some time and was well known at the clinic as well as by EMS personnel. There were always two, and occasionally three, doctors on duty at South Pasadena Clinic between 8:00 and 5:00 daily and, unless the patient requested a specific doctor he was treated by the first available doctor. Stroganow had not specifically requested to be treated by Respondent. When the Cares unit met with Respondent they advised him that Stroganow had been taken to Metropolitan General Hospital Emergency Room the previous evening but did not advise Respondent that the EMS squad had refused to return Stroganow to the emergency Room when they were recalled for Stroganow the same evening. Respondent telephoned the Metropolitan General Emergency Room and had the emergency Room medical report on Stroganow read to him. With the information provided by the Cares unit and the hospital report, Respondent concluded that Stroganow needed emergency medical treatment and the quickest way to obtain such treatment would be to call the EMS and have Stroganow taken to an emergency Room for evaluation. When the Cares unit arrived, Respondent was treating patients at the clinic. A clinic, or doctors office, is not a desirable or practical place to have an incontinent, incoherent, and non-ambulatory patient brought to wait with other patients until a doctor is free to see him. Nor is the clinic equipped to perform certain procedures that may be required for emergency evaluation of an ill patient. At a hospital emergency Room such equipment is available. EMS squads usually arrive within minutes of a call being placed to 911 for emergency medical treatment and it was necessary that someone be with Stroganow when the EMS squad arrived. Accordingly, Respondent suggested that the Cares team return to Stroganow and call 911 to transport Stroganow to an emergency Room for an evaluation. Upon leaving the South Pasadena 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 with Stroganow. The supervisor then called the Administrator at IMC Tampa Office to tell them that one of their Gold-Plus HMO patients had an emergency situation which was not being property handled. Respondent left the South Pasadena Clinic around noon and went to IMC's Tampa Office where he was available for the balance of the afternoon. There he spoke with Dr. Sanchez, the INC Regional Medical Director, but Stroganow was not deemed to be a continuing problem. By 2:00 p.m. when no ambulance had arrived the Cares Unit called 911 for EMS to take Stroganow to an emergency Room. Upon arrival shortly thereafter the EMS squad again refused to transport Stroganow. The Cares team communicated this to their supervisor who contacted IMC Regional Office to so advise. At this time Dr. Sanchez authorized the transportation of Stroganow to Lake Seminole Hospital for admission. Although neither Respondent nor Sanchez had privileges at Lake Seminole Hospital, IMC had contracted with Lake Seminole Hospital to have IMC patients admitted by a staff doctor at Lake Seminole Hospital. Subsequent to his meeting with the Cares team Respondent received no further information regarding Stroganow until well after Stroganow was admitted to Lake Seminole Hospital. No entry was made on Stroganow's medical record at IMC of the meeting between Respondent and the Cares Unit. Respondent was a salaried employee whose compensation was not affected by whether or not he admitted an IMC Gold-Plus patient to a hospital.
The Issue In DOAH Case No. 04-0025, the issue is whether the Agency for Health Care Administrative (AHCA) correctly assigned conditional licensure status to Lady Lake NH, L.L.C., d/b/a/ Lady Lake Specialty Care Center (Lady Lake) for the period of August 26, 2003, through October 3, 2003. In DOAH Case No. 04- 1065, the issues are as follows: (a) whether Lady Lake committed a violation of 42 C.F.R. Section 483.25, as it relates to care of patients with or who develop pressure sores; (b) whether Lady Lake committed a violation of 42 C.F.R. Section 483.75, as it relates to clinical records; and (c) if so, what, if any, penalty should be imposed.
Findings Of Fact AHCA is the agency that is responsible for licensing nursing homes and for enforcing Chapter 400, Part II, Florida Statutes, and Florida Administrative Code Chapter 59A-4. This includes enforcement of federal nursing home regulations in the Code of Federal Regulations specifically referenced in this case. Lady Lake owns and operates Lady Lake Specialty Care Center (the facility), a 120-bed skilled nursing facility located in Lady Lake, Florida. The facility operates under license # SNF130470994. At all times material here, the facility was licensed under AHCA's authority. Accordingly, the facility was required to comply with all applicable statutes, rules, and regulations. The facility is a long-term care provider under Medicaid and Medicare. As such, it is subject to federal regulation relating to compliance with 42 CFR Section 483. AHCA has the statutory authority and mandated duty, pursuant to Section 400.23(7), Florida Statutes, to evaluate all nursing homes facilities periodically (at least every 15 months). After each such evaluation, AHCA must assign a licensure status of "standard or conditional" to each licensee. On or about August 26, 2003, AHCA conducted a monitoring survey at the facility. As a result of the survey, AHCA cited the facility for a quality of care deficiency. AHCA based the deficiency upon finding of an alleged lack of proper care of one male resident (hereinafter referred to as "the resident"). More specifically, the citation was for an alleged violation of 42 CFR Section 483.25(c), which pertains to quality of care as it relates to pressure sores. A violation of 42 CFR Section 483.25(c) is commonly referred to as a Tag F-314 deficiency. AHCA determined that the scope of the Tag F-314 deficiency was isolated. AHCA also determined that the nature of the Tag F-314 deficiency was a Class II violation. Pursuant to leave granted, AHCA also charged Lady Lake with violating 42 CFR Section 483.75(l)(1), and/or Section 400.141(21), Florida Statutes, by failing to properly document treatment and care. This violation is commonly referred to as a Tag F-514 deficiency. AHCA determined that the scope of the Tag F-514 deficiency was isolated. AHCA concluded that the Tag F-514 deficiency was a Class II violation. AHCA assigned conditional licensure status to the facility for the period August 26, 2003, to October 3, 2003. AHCA seeks to impose an administrative fine in the amount of $2,500 for the Tag F-314 deficiency and $2,500 for the Tag F-514 deficiency. Lady Lake admitted the 81-year-old resident to the facility on July 31, 2003. At that time, the resident was severely contracted and bedridden. He had much comorbidity, including but not limited to, severe dementia, severe cardiac disease, peripheral vascular disease, end-stage Parkinson's disease, incontinence, cancer, and diabetes mellitus. The resident was non-verbal, non-ambulatory, and emaciated. The resident's records include a Transfer Summary from the Marion County Hospice, dated July 30, 2003. The Transfer Summary indicates that the resident's legs were contracted, that his skin was intact, and that he was using a low-air mattress. When the resident was a patient at the Marion County Hospice, he suffered a number of pressure sores on his feet and legs and at least one Stage III pressure sore on his coccyx. These pressure sores developed at the hospice even though the resident received appropriate care because they were unavoidable given his physical condition. The resident was at "high risk" for pressure sores. He scored a "9" on the Braden Scale for evaluating such risks. A score below "12" is a "high risk" patient. Pressure sores are classified as follows: (a) in Stage I as a persistent area of skin redness (without a break in the skin) that cannot be blanched and which does not disappear within 30 minutes when pressure is relieved; (b) in Stage II as a partial loss in the thickness of skin layers that presents clinically as an abrasion, blister, or shallow crater; (c) in Stage III as a loss of a full thickness of skin layers, exposing the subcutaneous tissues and presenting a deep crater with or without undermining adjacent tissue; and (d) in Stage IV as missing a full thickness of skin and subcutaneous tissues, exposing the muscle and/or bone. Upon admission to the facility, the resident had a red area on the plantar region of the foot below and toward the outer aspect of the great right toe. This red area was a pressure sore in the initial stage with undetermined damaged below. In fact, the resident could have suffered pressure trauma during transit from the hospice to the facility, causing damage to the foot. The facility's Assistant Director of Admissions (ADON) instructed the admission nurse to document the resident's pressure sore so that the facility would not be blamed. However, the admission nurse did not record the red area as a Stage I pressure sore. Instead, she noted that there was no skin impairment with the exception of a reddened area on the outer aspect of the right great toe. She also noted that sheepskin heel protectors were in place. The first charge nurse to attend the resident on the day of his admissions made the same observations. There is no way to determine at the time of a Stage I pressure sore how much underlying tissue has been damaged and how large the wound may become. A wound may look very small, but within a short period of time become huge because there is underlying tissue damage. Additionally, a reddened area on one spot may surface as an open area somewhere else due to underlying tissue damage. The damaged tissue must be removed before new tissue can fill the wound. Tissue damage equates to tissue death. A pressure sore may unavoidably escalate to a Stage III or Stage IV due to tissue damage beneath the skin. This is especially true in cases where the patient, such as the resident here, has severe peripheral vascular disease and lack of adequate blood supply. The healing of the resident's pressure sore was negatively impacted by its location on the foot. The resident's peripheral vascular disease caused a decreased amount of blood circulation to the foot. Further, the resident was not active and therefore was not achieving a good heart rate, which meant that the cardiac output was low. Cardiac output is important in providing blood with oxygen, hemoglobin, and red blood cells to the wound to assist in the healing process. Between the time that the resident was admitted and August 7, 2003, there was no physician order for specific treatment of the reddened area on the resident's foot. There is no persuasive evidence that any such treatment was required. The Weekly Skin Review dated August 7, 2003, identified the damaged tissue on the resident's foot as a pressure sore. The August 7, 2003, Skin Grid indicates that it was a new site of skin impairment that was not present on admission. The pressure sore was documented as a new site of skin impairment because it was no longer just a reddened area typical of Stage I, but had progressed to Stage II, clearly visible as a black/blue area, 3 cm by 3 cm, with no depth or drainage. On August 7, 2003, the resident's doctor ordered a skin preparation to be applied to his right plantar foot region three times daily. At that point in time, the nurses transferred the order to the Treatment Administration Record (TAR), which is just one of the places that the facility uses to document treatment. On the day it was ordered, the treatment was rendered to the resident one time. This is most likely because the facility had to secure the doctor's order and receive the product from the pharmacy before treatment could begin. On August 8, 2003, the nurses on two shifts recorded the skin preparation treatment on the TAR. On August 9 and 10, 2003, all three shifts noted the skin preparation treatment on the TAR. On August 11, 2003, two nurses noted the skin preparation treatment on the TAR. The third nurse presented credible testimony that she provided the treatment even though she did not record it on the TAR. On August 11, 2003, the doctor issued an order for the pressure sore to be cleaned daily, treated with TAO, and covered with non-stick telfa. The TAR reflects that the nurses changed the dressing once on August 12, once on August 14, twice on August 15, once on August 16, twice on August 18, and once on August 20. However, the greater weight of the evidence indicates that the facility's staff complied with the doctor's orders even through they did not always document their treatments. On August 13, 2003, the Weekly Skin Review identified no new areas of skin impairment. The August 14, 2003, Skin Grid notes that the Stage II pressure sore had not changed in size, but was pink in color. On August 20, 2003, the Weekly Skin Review identified no new areas of skin impairment. The August 20, 2003, Skin Grid notes that the Stage III pressure sore had not changed in size or color but had some drainage and minimal odor. On August 21, 2003, the resident's doctor issued an order for the pressure sore to be treated twice a day with Santyl in the middle and TAO on the edges then wrapped with curex until healed. The facility's staff complied with the doctor's orders and recorded the treatments on the TAR twice a day until the doctor discontinued them on August 27, 2003. The resident was placed on the facility's Magnolia Wing. The facility usually places Medicare patients on this wing. The nurses on the Magnolia Wing use Medicare documents such as the forms for Daily Skilled Nursing Notes (DSNN). Because the resident was a private-pay patient, the nurses were not required to document his condition on the Medicare forms on a daily basis. In fact, the nurses were not required to fill out the DSNN at all. They were only required to chart his progress on a weekly basis or when there was a significant change that required charting. The use of the DSNN was at the facility's discretion. Under the facts of this case, the nurses were not expected to check off every box on the DSNN that was relevant or to write a comment on each shift. They were expected to "document by exception," noting anything on their shift that was out of the ordinary for the resident. It is acceptable practice in long-term care nursing to "chart by exception" as it would be insurmountable to chart every thing that a resident does on a daily basis. While the records reflect that some nurses charted routine care of the resident, that charting is indicative of the nurses' training or experience in another setting. The facility's system of documentary communication included, but was not limited to, Nurse's Notes, TAR, and Medication Administration Record (MAR). Other documentary forms were used for skin assessments and wound care treatment. The facility's staff also communicated with each other about the resident's condition by conducting shift-change meetings and nurses' rounds and by checking the dates and nurses' signatures on bandages. These methods of communication met the community standard for good nursing. The nurses and their assistants were not required to document every time they turned and repositioned the resident because it was not an "activity of daily living" for charting purposes. The nurses noted on the TAR that the resident needed to be turned every two hours. They made this notation merely as a reminder to turn the resident. There was no doctor's order to accomplish this task. There was a bear symbol on the resident's door to remind the staff that he needed skin precautions, including turning and repositioning. In any event, turning and repositioning the resident would have had no effect on the foot wound because his foot was not on the bed. Reviewing the MAR, TAR, Nurses' Notes, and DSNN together, there is consistent documentation of treatment being rendered in accordance with the doctor's orders. There is no persuasive evidence that any lack of documentation in the resident's medical records adversely impacted the resident's health and welfare or constituted a deficiency. Lady Lake substantially complied with the requirement to document the care and treatment of the resident. The resident was admitted to the facility on a pressure reduction mattress. The facility provided him with a low-air mattress on August 21, 2003. His mattress was upgraded on two occasions. Providing a long-term care patient like the resident with a pressure-relieving mattress is such a routine intervention that it does not require charting or a doctor's order. Regardless of the type of mattress provided, it did not impact the pressure sore because the resident's foot did not rest on the mattress. On August 26, 2003, AHCA's surveyor asked to observe the resident's wound. A nurse removed the dressing from the resident's foot. AHCA's surveyor had to pry the resident's right foot from where it pressed against his left leg in order to observe the Stage III pressure sore on the ball of the resident's right foot. The wound was crater-like, with irregular edges that were red and meaty looking. The surveyor was unable to determine its depth due to what appeared to be drainage. The bandage could not be reapplied because the nurse assisting the surveyor did not have a key to the medication cart. On August 26, 2003, the wound was covered with a slimy or gelatinous material, which could be attributed at least in part to the Santyl treatment. Santyl is a collagenase debriding agent that dissolves necrotic tissue without causing any harm to the new healing tissue. The use of Santyl can cause a wound to appear gelatinous and green or brown. It would not have been appropriate, at the time of the survey, to remove the gelatinous material from the wound to determine its depth. Because healing starts at the base of the wound, it should not be forcibly cleaned or rubbed. A wound can be left undressed for a period of time if it has not dehydrated. There was no evidence that the resident's wound became dehydrated on August 26, 2003, or at any other point in time. The resident's pressure sore never became infected. An infection would have been likely if he had not received appropriate treatment for the wound. The surveyor did not see any pillows on the bed or in the resident's room. However, the greater weight of the evidence indicates that the resident would have had many more skin problems if the facility staff had not been turning and repositioning him with pillows every two hours. Without pillows, the facility's staff would not have been able to position the resident on his back to feed him. The staff used pillows to separate the resident's legs to relieve the pressure on the foot to the extent possible. Repositioning with pillows is a standard procedure in long-term care facilities. The bandage on the pressure sore acted as padding to eliminate any friction on the pressure sore. The resident's pressure sore never progressed to Stage IV, which requires exposed bone or muscle. The only record of a Stage IV pressure sore is found in the Minimum Data Set (MDS). It is necessary to record a pressure sore as Stage IV on the MDS when it has a blister and the depth cannot be determined. Furthermore, there is no difference in the care rendered to a patient with a Stage III or Stage IV pressure sore. The resident's pressure sore changed to a Stage II before he was transferred out of the facility. The greater weight of the evidence indicates that the resident's ability to reach his highest practicable mental, physical and psychosocial well-being was not compromised by Lady Lake in regard to the quality of care provided or in regard to documenting his condition.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That AHCA enter a Final Order dismissing the Administrative Complaints in both cases. DONE AND ENTERED this 15th day of December, 2004, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD 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 15th day of December, 2004. COPIES FURNISHED: Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Tom R. Moore, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308-5403 Charlene Thompson, Acting Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308
