The Issue The issues in this case are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2000),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2006). At all times material to this proceeding, Dr. Figueroa was a licensed physician within the State of Florida, having been issued license number ME 60819. Dr. Figueroa is board- certified in Family Practice. At all times material to this proceeding, Dr. Figueroa was the supervisor and employer of mid-level provider Carl Sellers, P.A. (Mr. Sellers). G.C., a 33-year-old male, first presented to Mr. Sellers as a new patient on November 14, 2000. G.C. complained of a two-month history of coughing, low-grade fever, fatigue, and heavy breathing. G.C.'s temperature was 98.4, his weight was 181 pounds, and his heart rate was 68 beats per minute. Mr. Sellers conducted an examination of G.C. and noted that G.C. was having difficulty taking a deep breath, shortness of breath on inspiration that was better if standing upright, severe fatigue, and fits of couching where he nearly vomited. Mr. Sellers also noted that G.C. had mild lymph adenopathy. Mr. Sellers' diagnosed G.C. with a persistent upper respiratory infection. He prescribed Zithromax and Guaifed TR and ordered a chest X-ray and blood testing, including a complete blood count (CBC) with differential, comprehensive metabolic profile (CMP), and erythrocyte sedimentation rate (ESR). G.C. was instructed to return in a week or sooner if he worsened. Dr. Figueroa's normal operating practice was to review Mr. Sellers' files of the previous day on the following morning. Dr. Figueroa reviewed G.C.'s medical record and concurred with Mr. Sellers' diagnosis. Laboratory results from the blood testing arrived in the office of Dr. Figueroa on November 20, 2000. G.C.'s blood testing results revealed abnormal liver function, anemia, borderline protein, and an abnormal sedimentation rate. The results of the blood tests did not warrant immediate follow-up with G.C. Mr. Sellers reviewed the laboratory report of the blood tests and indicated that he would discuss the results with G.C. on his next visit. G.C. was scheduled for a return visit on November 21, 2000, but called Dr. Figueroa's office and rescheduled his appointment for November 22, 2000. G.C. failed to keep his scheduled appointment. On November 22, 2000, Mr. Sellers reviewed the Radiological Report for G.C. The report stated: The lungs are clear of infiltrates. There is mild blunting of the costophrenic sulci probably representative of small effusions. The heart size is moderately enlarged. No pulmonary edema nor widening of the superior mediastinum detected. The impression of the radiologist was "moderate cardiomegaly with probably small pleural effusions." The Department's expert, Dr. Rafool, testified that the Radiological Report was an indication that G.C.'s heart was failing, which was inconsistent with the initial diagnosis of upper respiratory infection. Dr. Figueroa and his expert, Dr. Harold, testified that radiologists often "over read" chest X-rays; therefore, the Radiological Report did not warrant emergent action by Dr. Figueroa. Dr. Rafool countered the common over-read argument by testifying that regular radiologists do not equivocate because it causes more work for the ordering physician. The language of the radiologist is clearly intended to alert Dr. Figueroa to the presence of unusual conditions observed in G.C.'s chest X-ray that were inconsistent with an upper respiratory infection. Dr. Rafool's testimony is more credible concerning the significance of the Radiological Report and its implications on the diagnosis of G.C. Dr. Rafool testified that the Radiological Report indicated that G.C.'s heart was failing, which constitutes a "medical emergency" that required urgent notification of the patient. Dr. Figueroa and Dr. Harold conceded that the report indicated conditions that warranted "timely" follow-up, but not immediate intervention or contact with the patient. The Radiological Report revealed a "moderate" cardiomegaly that was an indication of cardiomyopathy, a heart condition that is more often fatal if not corrected by treatment that may include a heart transplant. Since early intervention is likely to lead to an opportunity for a favorable outcome, the testimony of Dr. Rafool is more credible regarding the need for notification of the patient. The record does not indicate any affirmative effort by Dr. Figueroa, his staff, or by Mr. Sellers to contact G.C. between November 22 and November 27, 2000, which was the next time that G.C. presented to Dr. Figueroa's office. On November 27, 2000, G.C. was complaining of worsening conditions since November 23 including swollen legs, inability to sleep at night, and coughing with shortness of breath mainly at bedtime. G.C.'s temperature was 97.2, his weight was 188 pounds, and his heart rate was 114 beats per minute. Mr. Sellers conducted an examination of G.C. and noted definite lid lag with mild exophthalmia, crackles in the lungs with no wheeze, moderate jugular vein distention, orthopnea, grade +2 pitting edema, and no goiter. Mr. Sellers ordered a STAT EKG on G.C. The EKG indicated "sinus tachycardia with occasional ventricular premature complexes and possible left atrial enlargement." Mr. Sellers documented that G.C. might be suffering from left ventricular hypertrophy. Mr. Sellers' primary diagnosis of G.C. was hyperthyroid crisis (storm), his secondary diagnosis was mild congestive heart failure secondary to hyperthyroid crisis caused by high output failure, his third diagnosis was IDA, the fourth diagnosis was elevated liver function tests and bilirubin, and the fifth diagnosis was insomnia. Mr. Sellers mistakenly diagnosed G.C. with a hyperthyroid crisis. Mr. Sellers consulted with Dr. Figueroa, who also examined G.C. Dr. Figueroa concurred with the assessment, diagnosis, and treatment plan of Mr. Sellers, including the diagnosis of hyperthyroid crisis. He indicated on the EKG strip that he agreed with the findings of G.C.'s EKG. A patient in a hyperthyroid crisis requires immediate hospitalization. Dr. Figueroa did not hospitalize G.C. Mr. Sellers prescribed 40 mg of Lasix, daily; 40 mg of Inderal, twice daily; and 50 mg of propylthiouracil, three times daily. The propylthiouracil prescribed was an insufficient dose based on the diagnosis of hyperthyroid crisis. Dr. Harold testified that G.C. did not present clinical signs of pulmonary edema during Mr. Sellers' examination on November 27, 2000, based on a lack of acute distress, moist rales and rhonchi throughout the lung fields, and respiratory distress. Dr. Rafool opined that G.C. did present clinical signs of pulmonary edema based on the crackles in the lungs, neck vein distension, pitting edema, elevated heart rate, and weight gain. The Department has failed to establish by clear and convincing evidence that pulmonary edema was ever clinically apparent to Dr. Figueroa or Mr. Sellers. In fact, hours after G.C. was examined by Dr. Figueroa and Mr. Sellers, the emergency room physicians did not diagnose G.C. with pulmonary edema. Inderal is contraindicated in the presence of pulmonary edema. Since pulmonary edema was not clinically apparent, Inderal was appropriately prescribed. Mr. Sellers' diagnosis of mild congestive heart failure was incorrect. Based on the symptoms exhibited by G.C. of neck vein distension, weight gain, orthopnea, and grade +2 pitting edema, it should have been apparent that G.C. had severe heart failure. G.C. presented to the Bayfront Medical Center Hospital Emergency Room at 10:03 p.m. on November 27, 2000. G.C. complained of abdominal pain and swelling, nausea and vomiting, and difficulty breathing. Examination of G.C. by emergency room personnel revealed the presence of bibasilar rales, but good breath sounds. Hospital chest X-ray revealed cardiomegaly, no infiltrates. At 1:33 a.m. on November 28, 2000, G.C. went into cardiac arrest. G.C. was pronounced dead at 3:04 a.m., November 28, 2000. An autopsy performed on G.C. revealed dilated cardiomyopathy, bi-ventricular dilation, pulmonary edema, and congested liver. The immediate cause of death was listed as idiopathic dilated cardiomyopathy. The autopsy report indicated that G.C. also had pulmonary edema; however, the pulmonary edema could have resulted from the large amounts of fluids that were being administered to G.C. by hospital staff during the last few hours of G.C.'s life. Dr. Figueroa was notified of G.C.'s demise on November 28, 2000, and he immediately sent his medical records on G.C. to his legal counsel without making any further notations on the records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Figueroa violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes; suspending his license to practice medicine until he completes the Florida C.A.R.E.S. program or a comparable physician skills assessment program to assess his clinical skills; requiring compliance with the program's recommendations; placing him on two years' probation with direct supervision to be set by the Board of Medicine; and imposing an administrative fine of $10,000. DONE AND ENTERED this 13th day of December, 2006, 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 13th of December, 2006.
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 ME 0020485. The Respondent has been licensed to practice medicine in the state of Florida since 1973. Respondent is Board Certified in Obstetrics and Gynecology having fulfilled the requirements of the American Board of Obstetrics and Gynecology. The requirements include a multi-year residency program in obstetrics and gynecology and successfully passing written and oral examinations. After graduating from medical school the Respondent completed a two- year residency in obstetrics and gynecology at St. Joseph's Hospital in Baltimore, Maryland. Respondent then spent one year as Chief Resident in Obstetrics and Gynecology at Lutheran Hospital in Baltimore, Maryland where approximately 2000 babies were born during the time Respondent was in residency. The Respondent then completed a two-year clinical fellowship in obstetrics and gynecology at Peninsula General Hospital in Salisbury, Maryland where approximately 3,000 babies were born each year during the time Respondent was in residency. Respondent received additional training in the subspecialty of fetal maternal medicine through a one-year fellowship at New Jersey Medical School. After the fellowship at New Jersey Medical School, Respondent served one year as a clinical instructor at University Hospital, affiliated with Mercy Hospital in Baltimore, Maryland. Since the time of his first residency, the Respondent has been involved in the delivery of several thousand babies. The Respondent moved to Florida in 1975 and has been engaged in the private practice of medicine since that time. The Respondent opened the Venice Obstetrics Clinic (Clinic) in 1983, and has served as its Medical Director since that time. The Clinic was at all times relevant to these proceedings licensed by the State of Florida in accordance with Sections 387.30 through 383.335, Florida Statutes, (referred to as the Birth Center Licensure Act). At all times relevant to these proceedings, the Respondent was permitted to perform surgical services (including episiotomies) and forceps delivery in the Clinic in accordance with the partial exemptions provided in Section 383.335(1), Florida Statutes. The Clinic's license has never been disciplined for noncompliance with Sections 383.30 through 383.335, Florida Statutes, or Chapter 59A-11, Florida Statutes, by the Department of Health and Rehabilitative Services (HRS), the agency charged with the responsibility of licensing and regulating birth centers. At all times relevant to these proceedings, Marcos Lara, M.D. acted as the Clinic's consultant, and was board certified with hospital privileges at St. Joseph's Hospital and at Faucett Memorial Hospital in Port Charlotte. In July 1988, the Clinic employed several nurses licensed by the state of Florida. At the time the patient K.Z. came into the Clinic, the nurse-to- patient ratio was two-to-one. Normally, the ratio was one-to-one. The patient's first visit to the clinic, and with Respondent, was on March 18, 1988. The patient continued with regular visits to the Clinic seeing the Respondent through July 8, 1988. On the patient's April 27, 1988 visit the Respondent gave the patient a score of "one" on the HRS, Pre-Term Delivery Risk Scoring Form (Form), indicating that the patient was a low-risk patient. On the patient's June 28, 1988 visit the Respondent gave the patient a score of "zero" on the Form, again indicating that she was a low-risk patient. The Respondent in scoring the patient's risk did not circle or use several of the risk factors listed on the Form that would have applied to the patient, including a patient under 20 years, single parent and low socioeconomic status. Based solely on the risk factors of (a) works outside of home, (b) younger than 20 years, (c) single parent, and (d) low socioeconomic status (based only on patient's level of education), and the points assigned those risk factors, the Respondent should have given the patient a score of "six". This would have placed her in the medium-risk classification which requires a score between six and nine points. However, since the patient no longer worked outside of the home on June 28, 1988, the date of the reevaluation, her score would have been "five", placing her in the low-risk classification. Many of the factors listed in the Form are risk factors used by obstetricians in assessing a patient's risk classification. However, many of the risk factors listed in the Form, including those risk factors used to assess this patient's risk classification, are not relied on solely by obstetricians, either singularly or in combinations, to assess a patient's risk classification. The purpose of the Form is to assist birth centers in assessing a patient's risk classification to determine whether the patient should be permitted to give birth in a birth center, and not to supplant the obstetricians' knowledge and skill in assessing a patient's risk classification. There is insufficient evidence to establish facts to show that Respondent's failure to correctly fill out the Form was the result of Respondent's failure to use his knowledge and skill as an obstetrician to properly assess the patient's risk classification and thereby fail to practice medicine within the prescribed standard of care. On June 28, 1988 the patient signed a form wherein she consented to the delivery of her child at the Clinic. At this time, the patient was advised of the risks of not delivering in a hospital and the advantages of delivering at a birth center. The normal period of gestation is 40 weeks. The methods used to calculate the estimated date of confinement (due date) are: (a) if a patient's menstrual periods are on a 28-day cycle, the due date can be determined by taking the last menstrual period (LMP) and adding 280 days; (b) substract three months from the LMP and add seven days; (c) an ultrasound can be used; (d) from the size of the fetus as determined by physical and pelvic examinations; and (e) fundal height measurement. None of these methods are absolutely accurate and therefore, the due date is considered an estimate. The fundus is the upper portion of the uterus which grows during pregnancy, with the cervix at the bottom portion of the uterus. The fundal height measurement is made from the top of the bone, which is the front of the pelvic, called the symphsis, to the top of the uterus. Both ends of this measurement are subjective in placement and vary between those making the measurement. Fundal height measurement is a way of determining the increase in size of the uterine content which is significantly, in normal cases, influenced by the growth of the fetus. The fundal height measurement is relevant to fetal age if it is consistent with other clinical assessments such as, how low is the baby to help determine the length, palpating to determine the width of the uterus, and a pelvic examination. Some obstetricians correlate the fundal height measurement with the gestation period where roughly one centimeter of fundal height equals one week of gestation, plus or minus two to four centimeters. While the Respondent measures the patient's fundal height at each visit, and did so with this patient, he does not use fundal height alone to determine the age of the fetus but uses fundal height in conjunction with other assessments found as a result of physical and pelvic examinations. On her first visit, the patient told the Respondent that her LMP had begun around the first part of December, 1987. Assuming the patient's LMP had begun on December 1, 1987, her due date should have been during the first week of September, 1988, using either method (a) or (b) above. Also on the patient's first visit the Respondent conducted physical and pelvic examinations. The physical examination consisted of palpation of the abdomen to note the size. The pelvic examination enabled the Respondent to assess the size of the uterus, which indicates the age of the pregnancy. Based on his physical and pelvic examinations of the patient on March 18, 1988 and the fundal height of 20 centimeters, the Respondent determined the age of the pregnancy to be 22 weeks with a due date of July 22, 1988. There was a difference in the due date calculated using the date expressed by the patient as her LMP as opposed to the due date determined by the Respondent from his clinical assessment as to the size of the fetus in conjunction with the fundal height. However, since the Respondent's clinical assessment did not reveal any problems, and the fact that approximately 25 percent of the pregnant women experience two or more false menstrual periods, the Respondent concluded that any size/date discrepancy was explainable. Therefore, the Respondent considered his determination of July 22, 1988 as the due date reasonable, and did not order an ultrasound since it was neither beneficial to the patient nor medically necessary at this point of the pregnancy. On April 27, 1988, June 8, 1988 and June 22, 1988 the Respondent measured the patient's fundal height as 23, 28 and 31 centimeters respectively. However, on these same dates the Respondent determined the age of the fetus to be 28, 34 and of the size of the fetus 36 weeks, respectively, based on his examination of the patient. On April 27, 1988, June 8, 1988 and June 22, 1988 the Respondent concluded that an ultrasound was not needed based on the same reasoning he had employed on March 18, 1988. On her June 28, 1988 visit, the Respondent performed physical and pelvic examinations, including palpating the abdomen, estimated the age of the fetus to be 39 weeks based on its size and advised the patient that her due date may be earlier than July 22, 1988, the initial due date. The fundal height measurement was 31 centimeters. Respondent's examination of the patient on her July 6, 1988 visit made him suspect twins and a possible abnormal delivery. Therefore, Respondent ordered an ultrasound. The ultrasound revealed a single baby in cephalic presentation (baby's head first), at term (fetus at least 37 weeks). The ultrasound did not indicate any problems in delivering the patient's baby. In fact, no risk factor was identified by the ultrasound. While the Respondent's records are sketchy in regard to his reasoning of the date/size discrepancy, the testimony of both the Respondent and Herbert F. Sandmire, M. D. supports the Respondent's reasoning in not ordering the ultrasound until the July 6, 1988 even though normally the date/size discrepancy may have justified the use of an ultrasound. Therefore, the Respondent was practicing medicine within the prescribed standard of care by not ordering an ultrasound until July 6, 1988 because there was sufficient reasons justifying the size/date discrepancy on the earlier dates, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. The patient went into labor on July 8, 1988. The patient arrived at the Clinic around 11:50 a.m. on July 8, 1988, and at that time her cervix was dilated two centimeters and was 100 per cent effaced. Nurses Sally Azima and Virginia Lane were assisting with the patient and made the notations on the Nurses' Notes, with Nurse Lane making the notes from 1:30 p.m. through 7:00 p.m. and Nurse Azima making the notes from 7:30 until the end of the Nurses Notes. The patient's fetal heart rate was monitored with a Doptone. A Doptone is a devise that is placed on the abdomen which allows the fetal heart beat to be heard in the room. At 5:27 p.m., the cervix was 9 centimeters, 100 per cent effaced with membranes bulging. At 7:00 p.m., the patient suffered dysfunctional labor. The patient's uterine contractions were irregular and weak. The Respondent decided to administer Pitocin to the patient in order to regulate her uterine contractions. Pitocin is a brand name for a drug that stimulates uterine contractions. Pitocin is used for dysfunctional labor. Pitocin does not increase any risk that is not already present, and no change in management decisions is needed merely because Pitocin is being administered to the patient. The Respondent administered Pitocin to the patient by making a single injection of one ampule (10 units) of Pitocin into an existing intravenous bag. Another method of administering Pitocin is referred to as the piggy- back system wherein the Pitocin is maintained in a separate bag and infused through the existing intravenous line. While the piggy-back system may be the preferred method of administering Pitocin to a patient, neither the Birth Center Licensure Act nor the prescirbed medical standard of care in July, 1988 required the use of the piggy-back system to administer Pitocin to a patient. At the time the Pitocin was injected, the existing intravenous bag contained approximately 900 milliliters of fluid, plus or minus 20 milliliters. The Respondent set the IV flow rate at 20 drops per minute which resulted in a dosage level of approximately 10 milliunits per minute. While a dosage level of 10 milliunits per minute of Pitocin is higher than what was previously thought to be the correct dosage level of Pitocin, a patient could benefit from the higher dosage level of Pitocin, particularly under the circumstances and conditions that existed with this patient on July 8, 1988. The Respondent was practicing medicine within the prescribed standard of care when he administered the higher dosage level of Pitocin to the patient on July 8, 1988, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. After setting the IV flow rate at 20 drops per minute, the Respondent instructed Nurse Azima to monitor the flow to be sure the flow remained at 20 drops per minute. Nurse Azima checked the flow by counting the drops with a second hand on her watch every 15 to 20 minutes. Nurse Azima, under the supervision of Respondent, has administered Pitocin using the drop count method ever since Respondent's residency in obstetrics. While the use of an infusion pump may be the preferred method of administering Pitocin by some obstetricians, the Respondent was practicing medicine within the prescribed standard of care when he used the drop count method of administering Pitocin to the patient on July 8, 1988 rather than using an infusion pump. His use of the drop count method, including allowing Nurse Azima to monitor the flow, met the prescibed standard of care, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. An electronic fetal monitor records both the baby's heart rate and the mother's uterine contractions, and presents this information on a graph. The Respondent did not use an electronic fetal monitor while administering Pitocin to the patient on July 8, 1988. Instead, Respondent used intermittent auscultation. Intermittent auscultation involves using a stethoscope or Doptone to listen to the fetal heart beat at prescribed intervals. A nurse is assigned to check the baby's heart beat periodically and to notify the physician of any abnormality. When an electronic fetal monitor is used, a nurse is assigned to watch the chart and notify the physician of any changes indicated by the chart. Intermittent auscultation is equivalent to electronic fetal monitoring when it is done on a frequent basis, such as listening every 30 minutes when the patient is in the active part of the first stage of labor and every 15 minutes during the second stage of labor. Pitocin was administered by the Respondent at 7:00 p.m. and thereafter, Nurse Azima checked the fetal heart rate every 15 to 20 minutes. However, she did not record the fetal heart rate each time because the fetal heart rate was within an acceptable range, nothing was abnormal. The Nurses Notes indicate that Nurse Azima recorded the fetal heart rate at 7:30 p.m., 8:30 p.m., 9:00 p.m. and 9:35 p.m. There was no indication of any abnormality in the patient's heart rate or of any fetal distress at any time during the course of the patient's labor. Again, while the use of an electronic fetal monitor may be preferred by some obstetricians, the Respondent was practicing medicine within the prescribed standard of care when he used intermittent auscultation instead of an electronic fetal monitor and in his use of intermittent auscultation on July 8, 1988, notwithstanding the testimony of Robert Brauner, M. D. or the information contained in the Physician's Desk Reference to the contrary. At 7:30 p.m. the patient was fully dilated and the fetal head was at "zero" station. Station refers to the progress of the fetal head down the pelvis toward the outside. When the very edge of the fetal head is even with an imaginary line drawn between the patient's two spines (prominence in the middle of patient's pelvis) the fetal head is considered at zero station. Progressing past zero station would be indicated as zero-plus-one station, plus-two, etc. Progressing past plus-three station would be delivery of the fetal head. At 8:00 p.m., the fetal head was in right occiput posterior (ROP) position. This means the baby's face, as the mother is lying on her back, is looking up and, is a less favorable position for delivery, in that it usually leads to a longer labor. At 8:30 p.m., an hour after the patient had been fully dilated, the fetal head was at zero-plus-one station. The fetal head was now in the occiput anterior (AO) position, meaning the baby is now looking straight down while the mother is lying on her back. This position is the favorable position for delivery. The patient was transferred to the procedure room, prepped and given a local anesthetic when the fetal head was at plus-one to plus-two station. Thereafter, the Respondent noted that patient was fully dilated, fetal head was at plus-two station, but there was no further descent of the head. At this point, the Respondent decided that the patient should be assisted in the delivery by using the forceps to bring the fetal head down and deliver the baby. Before applying the forceps, the Respondent performed an episiotomy on the patient. An episiotomy is a obstetrical cut made between the vagina and the rectum (the perineum), through the tissue, separating the muscle to help open the vagina for delivery. The decision on whether to perform the episiotomy before or after applying forceps is a matter of clinical judgment based upon the physical characteristics of the patient, in particular the size of the introitus and the perineum. The Respondent decided to perform the episiotomy on the patient before applying the forceps based on his clinical judgment of what was best for the patient. Forceps are obstetrical instruments used to assist in the delivery of the fetal head. The Respondent used Simpson forceps, a commonly used forceps, which are designed to come apart. The Respondent attempted forceps delivery several times without success, even with the patient pushing and fundal pressure being applied simultaneously by Nurse Azima and Nurse Lane. Fundal pressure is applied by pressing down on the top of the patient's abdomen to help in the delivery of the baby and is a fairly common obstetrical procedure. During the attempt to deliver the baby with the forceps the IV came out but was restored by the Respondent. The Pitocin was discontinued at this time. The Respondent was practicing medicine within the prescribed standard of care when he performed the episiotomy before the use of the forceps and in his attempt to delivery the baby with the forceps, notwithstanding Dr. Brauner's testimony to the contrary. After the unsuccessful attempt to deliver the baby with forceps, the Respondent decided to transfer the patient to a hospital for a cesarean section. Nurse lane was instructed by the Respondent to call for an ambulance. Nurse Lane called the Sarasota Fire Department which responded in approximately three minutes. After calling the Sarasota Fire Department, Nurse Lane called St. Joseph's Hospital and advised the hospital that the patient would be on the way. The episiotomy was not bleeding excessively and the bleeding could be controlled by packing the incision with gauze sponges and keeping the patient lying down with her legs together. Since the repair of the episiotomy would have required 10 to 15 minutes, the Respondent, using his best clinical judgment, decided to control the bleeding as set out above rather than to repair the episiotomy and delay the patient's transport to the hospital. The patient's life or well-being was not threatened by not repairing the episiotomy. While blood loss is a concern, specially for someone facing an operation, apparently the blood loss for this particular patient was not an overriding concern since the decision was made at the hospital not to repair the episiotomy until after the cesarean section, some two hours later. Under the circumstances and conditions existing at the time, the Respondent was practicing medicine within the prescribed standard of care when he, in his best clinical judgment, decided not repair the episiotomy which would have delayed transporting the patient to the hospital. Upon arrival the paramedics were advised of the patient's condition, that the patient was to be transported to St. Joseph's Hospital and that the Respondent was attempting to reach Respondent's back-up physician. However, the Respondent did not want to delay transport of the patient to the hospital so he advised the paramedics to proceed to St. Joseph's Hospital in Port Charlotte before he had made contact with the back-up physician, other than with the doctor's answering service. On July 8, 1988 the Respondent's consultant (back-up obstetrician) was Dr. Lara, who was a Board certified obstetrician with hospital privileges at St. Joseph's Hospital in Port Charlotte. After the ambulance had departed for St. Joseph's Hospital, the Respondent, being unable to make contact with the Dr. Lara other than with answering service, called St. Joseph's Hospital and advised them of the patient's condition, Nurse Lane having already called the hospital to advised them that the patient was being transported there. In route to St. Joseph's Hospital, the paramedics made their own assessment of the patient's conditions and, under the conditions and circumstances existing at that time, decided to reroute the patient to the Venice Hospital which was closer. Venice Hospital did not have an obstetrical unit. Therefore, contact was established with a Dr. Chen, the supervising emergency room physician, who advised the paramedics to transport the patient to Venice Hospital for evaluation. After examining the patient, Dr. Chen called the Respondent and told him that he thought the patient was ready to deliver. However, after the Respondent told Dr. Chen of the patient's condition and not to delay getting the patient to a hospital with obstetrical service, Dr. Chen directed transport of the patient to Memorial Hospital in Sarasota. After talking with Dr. Chen, the Respondent called the Memorial Hospital, discussed the patient's condition with the nurse on the obstetrics floor, advised the nurse of what had been attempted with the patient, and that in his opinion a cesarean section was necessary. The Respondent left his phone number with the nurse so that the obstetrician handling the case could call the Respondent, if necessary. The obstetrician handling the patient's care at Memorial Hospital did not call Respondent and Respondent made no attempt to call the obstetrician. The patient was admitted to Memorial Hospital at 11:40 p.m., and was monitored with an external monitor for nearly 55 minutes before being taking to the operating room at 11:34 p.m. where she underwent an emergency cesarean section delivery at 11:49 p.m. After the delivery, the patient's episiotomy was repaired. Although the baby had forceps marks graded from "no marks" to "bad forceps marks" by personnel at Memorial Hospital, there was no evidence that the baby was in any way affected by the Respondent's attempted forceps delivery. The mother and the baby fared well while in the hospital and were discharged on July 12, 1988. There is competent substantial evidence to establish facts to show that the Respondent was practicing medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances throughout the treatment and management of the patient, K. Z. from March 18, 1988 through July 8, 1988. During the course of the hearing the Department stipulated on the record that it did not intend to pursue Count III of the Administrative Complaint (failure to keep written medical records justifying the course of treatment for the patient) and presented no evidence on this charge.
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 Counts I, II, III, IV, and V of the Administrative Complaint filed in this case. RECOMMENDED this 15th day of February, 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 February, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-3149 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. The following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parenthesis is the Finding(s) of Fact which so adopts the proposed finding(s) of fact: 1(1); 2(9,14); 3 -11 (15,24,30,32,32,26,27,29,and 28,respectively); 12(28,29); 13(32); 14(25,27); 15(25); 16(38); 17(32-34,36 and 38); 24(37); 26(28,29); 27 - 30(16-18 and 22, respectively); 32 - 35(19); 36(43,46); 38(51,53); 43(52); 47(55); 50(46); 52 - 59(60 - 63,65,67,68); 61(66); 64(74); 67(74); 68(75); 70(74- 76); 72-74(67,68); 76(69); 79-89(72-75,77,80-84); 90-94(77- 79,82,83); 96-97(83,84); 100(84); and 105-106(85). The following proposed findings of fact are not supported by competent substantial evidence in the record: 19, 21, 23, 25, 39-42, 44, 45, 48, 49, 51, 62, 63, 69, 71, 78, 95, 98, and 99. The first sentence of proposed findings of fact 18, 20, 22 and 37 are adopted in Findings of Fact 32, 34 and 44. The balance of proposed findings of fact 18, 20, 22 and 37 are not supported by competent substantial evidence in the record. The following proposed findings of fact are neither material nor relevant to the conclusion reached in the Recommended Order: 31, 46, 60, 65, 66, 75, 77, 101 - 104 and 107. 6. The Findings of Fact 1 - 30 concerning Expert Witnesses go to the credibility of those expert witnesses and are not addressed in the Findings of Fact. Respondent's Proposed Findings of Fact. Proposed findings of fact 1 - 11 are adopted in substance as modified in Findings of Fact 2 - 12, respectively. Proposed finding of fact 12 is unnecessary. Proposed findings of fact 13 and 14 are adopted in substance as modified in Finding of Fact 13. Proposed findings of fact 15 and 16 are adopted in substance as modified in Findings of Fact 14, 15 and 19. Proposed findings of fact 17 - 24 are adopted in substance as modified in Findings of Fact 25, 27, 30 - 33 and 84. Proposed findings of fact 25 - 29 are adopted in substance as modified in Findings of Fact 27, 28, 31, and 34. Proposed findings of fact 30 - 36 are adopted in substance as modified in Findings of Fact 25,33 and 37. Proposed findings of fact 37 - 45 are adopted in substance as modified in Findings of Fact 16 - 24. Proposed findings of fact 46 - 52 are adopted in substance as modified in Findings of Fact 39 - 42. Proposed findings of fact 53 - 56 are adopted in substance as modified in Findings of Fact 43 - 45. Proposed findings of fact 57 - 61 are adopted in substance as modified in Findings of Fact 46 - 49. Proposed findings of fact 62 - 68 are adopted in substance as modified in Findings of Fact 50, 51 and 69. Proposed findings of fact 69 - 88 are adopted in substance as modified in Findings of Fact 52 - 58. Proposed findings of fact 89 - 94 are adopted in substance as modified in Findings of Fact 59 - 64. 15 Proposed findings of fact 95 - 100 are adopted in substance as modified in Findings of Fact 65 - 71. Proposed findings of fact 101 - 110 are adopted in substance as modified in Findings of Fact 71 - 76. Proposed findings of fact 111 - 129 are adopted in substance as modified in Findings of Fact 77 - 83. Proposed findings of fact 129 - 137 are adopted in substance as modified in Findings of Fact 84 - 86. Proposed findings of fact 138 - 162 are matters relating to the witnesses and go to the credibility of those witnesses and are not addressed as Findings of Fact. COPIES FURNISHED: Michael K. Blazicek, Esquire Senior Attorney Department of Professional Regulation 730 South Sterling Avenue, Suite 201 Tampa, Florida 33609-4582 Darol Carr, Esquire Farr, Farr, Emerich & Hackett, P. A. 2315 Aaron Street Post Office Box 2159 Port Charlotte, Florida 33949 James W. Linn, Esquire Carson, Linn & Adkins 1711-D Mahan Station Tallahassee, Florida 32308 Dorothy Faircloth Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
The Issue Whether there is need for a new Pediatric Heart Transplant and/or Pediatric Heart and Lung Transplant program in Organ Transplant Service Area (OTSA) 3; and, if so, whether Certificate of Need (CON) Application No. 10471 (heart) and/or 10472 (heart and lung), filed by The Nemours Foundation, d/b/a Nemours Children’s Hospital (Nemours or NCH), to establish a Pediatric Heart Transplant and/or Pediatric Heart and Lung Transplant program, satisfy the applicable statutory and rule review criteria for award of a CON.
Findings Of Fact Based upon the demeanor and credibility of the witnesses and other evidence presented at the final hearing and on the entire record of this proceeding, the following Findings of Fact are made: The Parties The Applicant, Nemours Nemours Children’s Hospital is a licensed Class II specialty children’s hospital located in Orange County, Health Planning District 7, Subdistrict 7-2, OTSA 3, which is owned and operated by The Nemours Foundation. Nemours is licensed for 100 beds, including 73 acute care, nine comprehensive medical rehabilitation, two Level II neonatal intensive care unit (NICU), and 16 Level III NICU beds, and is a licensed provider of pediatric inpatient cardiac catheterization and pediatric open-heart surgery. As the primary beneficiary of the Alfred I. duPont Testamentary Trust established in the will of Alfred duPont, the Foundation was incorporated in Florida in 1936. The Foundation set out to provide children and families medical care and services, its mission being “[t]o provide leadership, institutions, and services to restore and improve the health of children through care and programs not readily available, with one high standard of quality and distinction regardless of the recipient’s financial status.” Foundation assets reached $5.5 billion, by the end of 2015. The Foundation has funded $1.5 billion of care to Florida’s pediatric population through subspecialty pediatric services, research, education, and advocacy. Nemours has established a pediatric care presence throughout the State of Florida. Nemours operates over 40 outpatient clinics throughout Florida that offer primary care, specialty care, urgent care, and cardiac care services to pediatric patients in central Florida, Jacksonville, and the panhandle region. Nemours also provides hospital care to pediatric inpatients at Nemours Children’s Hospital in Orlando, as well as through affiliations with Wolfson’s Children’s Hospital in Jacksonville, West Florida Hospital in Pensacola, and numerous hospital partners in central Florida. The resources Nemours offers in the greater Orlando area are especially significant with 17 Primary Care Clinics, five Urgent Care Clinics, 10 Specialty Care Clinics, nine Nemours Hospital partners, and, of course, NCH itself. These clinics are located throughout OTSA 3 where Nemours determined access to pediatric care was lacking, including Orlando, Melbourne, Daytona Beach, Titusville, Kissimmee, Lake Mary, and Sanford, as well as neighboring Lakeland. The clinics are fully staffed with hundreds of Nemours-employed physicians who live in the clinic communities. Through these satellite locations, as well as the Nemours CareConnect telemedicine platform, Nemours is able to bring access to its world-class subspecialists located at NCH to children throughout the State of Florida who otherwise would not have access to such care. Nemours was established to provide state of the art medical care to children through its integrated model. Nemours’ development has been and continues to be driven by its mission and objective to be a top-tier, world-class pediatric healthcare system. NCH is the first completely new “green field” children’s hospital in the United States in over 40 years, allowing Nemours to integrate cutting-edge technology and a patient-centered approach throughout. Nemours has created a unique integrated model of care that addresses the needs of the child across the whole continuum, connecting policy and prevention, to the highest levels of specialized care for the most complex pediatric patients. From its inception, Nemours envisioned the development of a comprehensive cardiothoracic transplant program as proposed by the CON applications at issue in this proceeding. NCH is located in the Lake Nona area, just east of downtown Orlando in a development known as Medical City. Medical City is comprised of a new VA Hospital, the University of Central Florida (UCF) College of Medicine and School of Biomedical Sciences, the University of Florida (UF) Research and Academic Center, the Sanford Burnham Medical Research Institute, and a CON-approved hospital, which is a joint venture between UCF and AHCA, which will serve as UCF’s teaching hospital. Medical City is intended to bring together life scientists and research that uses extraordinarily advanced technology. Co- location in an integrated environment allows providers and innovators of healthcare, “the brightest minds,” so to speak, to interact and to share ideas to advance healthcare and wellness efforts. Agency for Health Care Administration AHCA is the state health-planning agency that is charged with administration of the CON program as set forth in sections 408.031-408.0455, Florida Statutes. Context of the Nemours Applications Pursuant to Florida Administrative Code Rule 59C-1.044, AHCA requires applicants to obtain separate CONs for the establishment of each adult or pediatric organ transplantation program, including: heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestine transplantations. “Transplantation” is “the surgical grafting or implanting in its entirety or in part one or more tissues or organs taken from another person.” Fla. Admin. Code R. 59A-3.065. Heart transplantation, lung transplantation, and heart/lung transplantation are all defined by rule 59C-1.002(41) as “tertiary health services,” meaning “a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost effectiveness of such service.” AHCA rules define a “pediatric patient” as “a patient under the age of 15 years.” Fla. Admin. Code R. 59C-1.044(2)(c). AHCA rules divide Florida into four OTSAs, corresponding generally with the northern, western central, eastern central, and southern regions of the state. Fla. Admin. Code R. 59C-1.044(2)(f). The programs at issue in this proceeding will be located in OTSA 3, which is comprised of Brevard, Indian River, Lake, Martin, Okeechobee, Orange, Osceola, Seminole, and Volusia Counties. Currently, there are no providers of PHT in OTSA 3, and there are no approved PHLT programs statewide. The incidence of PHT in Florida, as compared to other types of solid organ transplants, is relatively small. The chart below sets forth the number of pediatric (ages 0-14) heart transplant discharges by year for the four existing Florida PHT programs during Calendar Years (CY) 2013 through 2016, and the 12-month period ending June 2017: HOSPITAL HEART TRANSPLANT CY 2013 CY 2014 CY 2015 CY 2016 12 MONTHS ENDING JUNE 2017 All Children’s Hospital 7 14 9 8 7 UF Health Shands Hospital 6 8 15 15 9 Memorial Regional Hospital 5 5 5 7 4 Jackson Health System 2 2 1 4 1 Total 20 29 30 34 21 The above historic data demonstrates that the incidence of PHT statewide is relatively rare, and does fluctuate from program to program and from year to year. As can be seen, the most recent available 12-month data reflects that only 21 PHTs were performed during that time, for an average program volume of only 5.25 cases. Florida has more existing and approved PHT programs than every other state in the country except California, which has more than double the pediatric population of Florida. And like Florida, two of the California programs are extremely low- volume programs. Additionally, evidence regarding the number of PHLT patients demonstrated just how rare this procedure is. From 2013 to 2016, there was an annual average of only four PHLTs nationally, with only one actual transplant on a Floridian. Nemours’ health planner stated that although Nemours projected in its application that it would perform one heart/lung procedure each year, it is a “very low-volume service,” and Nemours in actuality expects that there will be years with zero volume of PHLT. The CON Applications Nemours filed its applications for heart transplantation, heart/lung transplantation, and lung transplantation in the second Other Beds and Programs Batching Cycle of 2016. Nemours is proposing the development of a comprehensive cardiothoracic transplant program, which will be the only such program in Florida. This will be achieved by combining three types of transplant services (heart, lung, and heart/lung) in one comprehensive cardiothoracic transplant program. Each application was conditioned on the development of all three transplantation programs. Nemours is located in OTSA 3, where there is currently no PHT provider, PLT provider, or PHLT provider. There are, however, three providers of pediatric open-heart surgery and pediatric cardiac catheterization, and a large, growing pediatric population. Unlike any other facility in Florida, the Nemours Cardiac Center (Cardiac Center) is uniquely organized to treat all forms of congenital heart disease. The Cardiac Center employs a “programmatic approach” to offer the most beneficial environment and the finest care available for pediatric patients. The Cardiac Center, physically located at NCH, throughout Florida, is organized as a single Department of Cardiovascular Services to house Cardiac Surgery, Cardiac Anesthesia, Cardiac Intensive Care Unit (ICU), and Cardiology. Cardiac Center physicians throughout Florida are organized as a single entity with the goal of providing the highest quality, patient-centered care to all patients without the usual barriers created by the departmental “silos.” The entire Cardiac Center clinical team, including nurses and physicians, is dedicated solely to the special challenges of congenital heart abnormalities and makes the care of children with heart disease the life’s work of team members. The fully integrated organizational structure permits the team to take shared responsibility for all aspects of the delivery of quality care to these pediatric patients from admission to discharge. The Cardiac Center holds weekly patient consensus conferences, where all providers, including physicians, nurses, and the patients’ caregivers, participate in case reviews of all inpatients and those patients scheduled for surgery or catheterization. The Cardiac Center is “state of the art” with a designated cardiovascular operating room, a designated cardiovascular lab that includes an electrophysiology lab, and a dedicated comprehensive care unit. In addition, The Foundation has furthered the commitment to the Cardiac Center by funding an additional $35 million expansion to the sixth floor of NCH, adding an additional 31 inpatient beds, an additional operating room, and a comprehensive cardiovascular intensive care unit. Dr. Peter D. Wearden joined Nemours in 2015 as the chief of cardiac surgery, chair of the Department of Cardiovascular Services, and director of the Cardiac Center at Nemours. Dr. Wearden will serve as director of the Comprehensive Cardiothoracic Transplant Program at Nemours and will be instrumental in the development and implementation of the program. Dr. Wearden was recruited from the Children's Hospital of Pittsburgh (CHP), where he served as the surgical director of Heart, Lung, and Heart/Lung Transplantation. He was also the director of the Mechanical Cardiopulmonary Support and Artificial Heart Program. CHP rose to a US News and World Report top 10 program during Dr. Wearden’s tenure. CHP is at the forefront of organ transplantation and is where the first pediatric heart/lung transplantation was performed. Dr. Wearden is a trained cardiothoracic surgeon who completed fellowships in both cardiothoracic surgery (University of Pittsburgh) and Pediatric and Congenital Heart Surgery (Hospital for Sick Children, Toronto, Canada). He is certified by the American Board of Thoracic Surgery and holds additional qualifications in Congenital Heart Surgery from that organization. In his tenure as a board-certified pediatric transplant specialist, he has participated in over 200 pediatric cardiothoracic transplantations, of which he was the lead surgeon in over 70. In addition, he has procured over $20 million in National Institutes of Health research funding since 2004 specific to the development of artificial hearts and lungs for children and their implementation as a live-saving bridge to transplantation. Dr. Wearden was a member of the clinical team that presented to the Food and Drug Administration (FDA) panel for approval of the Berlin Heart, the only FDA-approved pediatric heart ventricular assist device (VAD)1/ currently available, and he proctored the first pediatric artificial heart implantation in Japan in 2012. A VAD is referred to as “bridge to transplant” in pediatric patients because the device enables a patient on a waiting list for a donated heart to survive but is a device on which a child could not live out his or her life. Both utilization of VADs and heart transplantation procedures are in the “portfolio of surgical interventions” that can save the life of a child with heart failure. Dr. Wearden is an international leader in the research and development of VADs. Victor Morell, an eminent cardiac surgeon and chief of Pediatric Cardiac Surgery at CHP, testified that Dr. Wearden’s presence in Orlando alone and the work that he will be able to do with VADs and a PHT program will likely save lives. Many of the physicians that comprise the Nemours Cardiac Center transplant team not only have significant transplant experience, but also have experience performing transplants together. These physicians came with Dr. Wearden from CHP, were trained by Dr. Wearden, or otherwise worked with Dr. Wearden at some point in their careers. The physicians recruited to the Nemours transplantation team were trained at or hail from among the most prestigious programs in the country. For example, Dr. Kimberly Baker, a cardiac intensivist, was trained by Dr. Wearden in the CHP ICU. Dr. Constantinos Chrysostomou, Nemours’ director of cardiac intensive care, worked with Dr. Wearden at CHP, and has experience starting the pediatric ICU in Los Angeles at Cedar Sinai Hospital. Dr. Steven Lichtenstein, chief of cardiac anesthesia, held the same position at CHP for 12 years before he was recruited to Nemours. Dr. Karen Bender, a cardiac anesthesiologist, was recruited by Dr. Wearden from the Children’s Hospital of Philadelphia – one of the leading programs in the country. Dr. Michael Bingler, a cardiac interventionalist, was at Mercy Children’s Hospital in Kansas City for eight years. Dr. Adam Lowry of the Nemours cardiac intensive care center previously trained at both Texas Children’s Hospital (the number one program in the country) and Stanford. The 11 physicians that comprise the Cardiac Center’s Cardiothoracic Physician Team have collectively participated in 1,146 cardiothoracic transplantations. These physicians came to Nemours to care for the most acute, critically ill patients, including those requiring PHT. In addition to the physician team, the expertise and skill of the non-physician staff in the catheterization lab, the operating room, and the cardiac ICU are crucial to a successful program. Dr. Dawn Tucker is the administrative director of NCH’s Cardiac Center and heads the nursing staff for NCH’s Cardiac Center, which includes 23 registered nurses with transplant experience. Dr. Tucker holds a doctorate of Nursing Practice and was formerly the director of the Heart Center at Mercy Children’s Hospital in Kansas City, where she oversaw the initiation of a PHT program. The average years of experience for total nursing care in cardiac units across the nation is two years. The average years of experience in the Nemours Cardiac Center is eight years. Medical literature shows the greater the years of nursing staff experience, the lower the mortality and morbidity rates. The nursing staff at Nemours, moreover, has extensive experience in dealing not only with pediatric cardiac patients, but with pediatric heart transplants as well. The Cardiac Center’s cardiothoracic nursing staff has over 220 years of collective cardiothoracic transplant experience. Nemours operates a “simulation center” that allows the Cardiac Center to simulate any type of cardiac procedure on a model patient before performing that procedure on an actual patient. The model patient’s “heart” is produced using a three- dimensional printer that creates a replica of the heart based on MRI’s or other medical digital imaging equipment. These replica hearts are printed on-site, using the only FDA-approved software for such use, and are ready for use in the simulation center within a day after medical imaging. Nemours Cardiac Center currently performs what the Society of Thoracic Surgeons has coined “STAT 5” cardiac procedures. STAT 5 cardiac procedures are the most complex; STAT 1 procedures are the least complex. A PHT is a STAT 4 procedure. Since Dr. Wearden’s arrival at the Nemours Cardiac Center, there have been no patient mortalities. The uncontroverted evidence established that Nemours has assembled a high-quality, experienced, and unquestionably capable team of physicians and advanced practitioners for its cardiothoracic transplantation programs and is capable of performing the services proposed in its applications at a high level. UF Health Shands While not a party to this proceeding,2/ UF Health Shands’ (Shands) presence at the final hearing was pervasive. AHCA called numerous witnesses affiliated with Shands in its case-in-chief. The scope of the testimony presented by Shands- affiliated witnesses was circumscribed by Order dated December 13, 2017 (ruling on NCH’s motion in limine) that: At hearing, the Agency may present evidence that the needs of patients within OTSA 3 are being adequately served by providers located outside of OTSA 3, but may not present evidence regarding adverse impact on providers located outside of OTSA 3. Baycare of Se. Pasco, Inc. v. Ag. for Health Care Admin., Case No. 07-3482CON (Fla. DOAH Oct. 28, 2008; Fla. AHCA Jan. 7, 2009). UF Health Shands Hospital is located in Gainesville, Florida. UF Health Shands Children’s Hospital is an embedded hospital within a larger hospital complex. Shands Children’s Hospital has 200 beds and is held out to the public as a children’s hospital. The children’s hospital has 72 Level II and III NICU beds. Unlike Nemours, Shands offers obstetrical services such that babies are delivered at Shands. It also has a dedicated pediatric intensive care unit (PICU) as well as a dedicated pediatric cardiac intensive care unit. The Shands Children’s Hospital has its own separate emergency room and occupies four floors of the building in which it is located. It is separated from the adult services. Shands Children’s Hospital is nationally recognized by U.S. News & World Report as one of the nation’s best children’s hospitals. The children’s hospital has its own leadership, including Dr. Shelley Collins, an associate professor of pediatrics and the associate chief medical officer. As a comprehensive teaching and research institution, Shands Children’s Hospital has virtually every pediatric subspecialty that exists and is also a pediatric trauma center. The children’s hospital typically has 45 to 50 physician residents and 25 to 30 fellows along with medical students. Over $139 million has been awarded to Shands for research activities. As a teaching hospital, Shands is accustomed to caring for the needs of patients and families that come from other parts of the state or beyond. Jean Osbrach, a social work manager at Shands, testified for AHCA. Ms. Osbrach oversees the transplant social workers that provide services to the families with patients at Shands Children’s Hospital. Ms. Osbrach described how the transplant social workers interact with the families facing transplant from the outset of their connection with Shands. They help the families adjust to the child’s illness and deal with the crisis; they provide concrete services; and these social workers help the families by serving as navigators through the system. These social workers are part of the multidisciplinary team of care, and they stay involved with these families for years. Shands is adept at helping families with the issues associated with getting care away from their home cities. Shands has apartments specifically available in close proximity to the children’s hospital and relationships with organizations that can help families that need some financial support for items such as lodging, transportation, and gas. Ms. Osbrach’s ability to empathize with these families is further enhanced because her own daughter was seriously ill when she was younger. Ms. Osbrach testified that, while she was living in Gainesville, she searched out the best options for her child and decided that it was actually in Orlando. Despite the travel distance, she did not hesitate to make those trips in order to get the care her child needed at that time. The Shands Children’s Hospital is affiliated with the Children’s Hospital Association, the Children’s Miracle Network, the March of Dimes, and the Ronald McDonald House Charities. Shands operates ShandsCair, a comprehensive emergency transport system. ShandsCair operates nine ground ambulances of different sizes, five helicopters, and one fixed-wing jet aircraft. ShandsCair does over 7,000 transports a year, including a range of NICU and other pediatric transports. ShandsCair is one of the few services in the country that owns an EC-155 helicopter, which is the largest helicopter used as an air ambulance. This makes it easier to transport patients that require a lot of equipment, including those on extracorporeal membrane oxygenation (ECMO). Patients on ECMO can be safely transported by ground and by air by ShandsCair. Shandscair serves as a first responder and also provides facility-to- facility transport. It has been a leader in innovation. The congenital heart program at Shands includes two pediatric heart surgeons, as well as pediatric cardiologists Dr. Jay Fricker and Dr. Bill Pietra, both of whom testified for AHCA. Dr. Fricker did much of his early work and training at the Children’s Hospital of Pittsburgh, and came to the University of Florida in 1995. He is a professor and chief of the Division of Cardiology in the Department of Pediatrics at Shands. He is also the Gerold L. Schiebler Eminent Scholar Chair in Pediatric Cardiology at UF. He has been involved in the care of pediatric heart transplant patients his entire career. Dr. Bill Pietra received his medical training in Cincinnati and did his early work at several children’s hospitals in Colorado. He came to the University of Florida and Shands in July 2014 and is now the medical director, UF Health Congenital Heart Center. Shands performed its first pediatric heart transplant in 1986. Shands treats the full range of patients with heart disease and performs heart transplants on patients, from infants through adults, with complex congenital heart disease. Shands provides transplants to pediatric patients with both congenital heart defects and acquired heart disease (cardiomyopathy). Shands will accept the most difficult cases, including those that other institutions will not take. Data presented by AHCA dating back to the beginning of 2014 demonstrate that Shands has successfully transplanted numerous patients that were less than six months old at the time of transplantation. This data also demonstrates that Shands serves all of central and north Florida, as well as patients that choose to come to Shands from other states. PHT patients now survive much longer than in the past, and in many cases, well into adulthood. Because Shands cares for both adult and pediatric patients, it has the ability to continue to care for PHT patients as they transition from childhood to adulthood. Managed care companies are now a significant driver of where patients go for transplantation services. Many managed- care companies identify “centers of excellence” as their preferred providers for services such as PHT. Shands is recognized by the three major managed-care companies that identify transplant programs as a center of excellence for PHT services. AHCA’s Preliminary Decision Following AHCA’s review of Nemours’s applications, as well as consideration of comments made at the public hearing held on January 10, 2017, and written statements in support of and in opposition to the proposals, AHCA determined to preliminarily deny the PHT and PHLT applications, and to approve the PLT application. AHCA’s decision was memorialized in three separate SAARs, all dated February 17, 2017. Marisol Fitch, supervisor of AHCA’s CON and commercial-managed care unit, testified for AHCA. Ms. Fitch testified that AHCA does not publish a numeric need for transplant programs, as it does for other categories of services and facilities. Rather, the onus is on the applicant to demonstrate need for the program based on whatever methodology they choose to present to AHCA. In addition to the applicant’s need methodology, AHCA also looks at availability and accessibility of service in the area to determine whether there is an access problem. Finally, an applicant may attempt to demonstrate that “not normal” circumstances exist in its proposed service area sufficient to justify approval. Statutory Review Criteria Section 408.035(1) establishes the statutory review criteria applicable to CON Applications 10471 and 10472. The parties have stipulated that each CON application satisfies the criteria found in section 408.035(1), (d), (f), and (h), Florida Statutes. The only criteria at issue essentially relate to need and access. However, the Agency maintains that section 408.035(1)(c) is in dispute to the extent that center transplant volume as a result of Nemours’ approval would lead to or correlate with negative patient outcomes. AHCA believes that there is no need for the PHT or PHLT programs that Nemours seeks to develop because the needs of the children in the Nemours service area are being met by other providers in the state, principally Shands and Johns Hopkins All Children’s Hospital. Section 408.035(1)(a) and (b): The need for the health care facilities and health services being proposed; and the availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the district of the applicant. Florida Administrative Code Rule 59C-1.044(6)(b).3/ The criteria for the evaluation of CON applications, including applications for organ transplantation programs, are set forth at section 408.035 and rule 59C-1.044. However, neither the applicable statutes nor rules have a numeric need methodology that predicts future need for PHT or PHLT programs. Thus, it is up to the applicant to demonstrate need in accordance with rule 59C-1.044. There are four OTSAs in Florida, numbered OTSA 1 through OTSA 4. NCH is located in OSTA 3, which includes the following counties: Seminole, Orange, Osceola, Brevard, Indian River, Okeechobee, St. Lucie, Martin, Lake, and Volusia. (See § 408.032(5), Fla. Stat; Fla. Admin. Code R. 59C- 01.044(2)(f)3.) OTSA 3 also generally corresponds with the pediatric cardiac catheterization and open-heart surgery service areas defined by AHCA rule. (See Fla. Admin. Code R. 59C- 1.032(2)(g) and 59C-1.033(2)(h)). Currently, there is no provider of PHT in OTSA 3, but there are three providers of pediatric cardiac catheterization and pediatric open-heart surgery: Orlando Health Arnold Palmer Hospital for Children; Florida Hospital for Children; and Nemours. There are no licensed providers of PHLT anywhere in the State of Florida. There are four existing providers and one approved provider of PHT services in Florida: UF Shands in OTSA 1; Johns Hopkins All Children’s Hospital in OTSA 2; Jackson Memorial Hospital in OSTA 4; and Memorial Regional Hospital, d/b/a Joe DiMaggio’s Hospital in OTSA 4; and a third approved program in OTSA 4, Nicklaus Children’s Hospital, which received final approval from AHCA in August 2017. As noted above, there is no fixed-need pool published for PHT, PHLT, or PLT programs. Alternatively, AHCA follows rule 59C-1.008(2)(e)2., which requires consideration of population demographics and dynamics; availability, utilization and quality of like services in the district, subdistrict, or both; medical treatment trends; and market conditions. To quantify the need for a new PHT program in District 7, OTSA 3, Nemours created and presented a methodology that started with the statewide use rate in its projected first year. Then for the second year, Nemours aggressively increased the use rate to the highest rate in any of the other transplant service areas in the state. Then, in an even more aggressive (and unreasonable) assumption, Nemours projected that it would essentially capture all of the cases in OTSA 3 by the second year of the program. In its application, the assumptions resulted in a projection that Nemours would do four transplants in the first year of operation and eight in the second. These projections fall short of the rule requirement that the applicant project a minimum of 12 transplants per year by the second year of operation. Fla. Admin. Code R. 59C-1.044(6)(b)2. At hearing, Nemours updated (increased) those first and second year projections to 7 and 13 cases, respectively. However, these updated projections included one child, aged 15 to 17, in year one, and two in year two. There are several reasons these projections lack credibility. First, as noted, Nemours assumed a near- 100 percent market share based on the highest use rate in the state by just year two. Second, when Nemours prepared its update, it used the most recent calendar year data. However, this was not the most current data. Calendar Year 2016 reflected 34 cases statewide, but that number had dropped to 21 for the most recent 12-month period available at the time of the hearing. Use of this most recent 12-month data would have significantly decreased the Nemours PHT volume projections. In addition, the projection of 13 cases by year two would place Nemours at a higher PHT case volume than three of the four established programs in the state, and would be at a level that is nearly equivalent to the much more established Shands program. This is not credible, especially considering that Nemours also admitted at hearing that only two OTSA 3 residents received pediatric heart transplants in 2016. The existence of unmet need cannot be based solely on the absence of an existing service in the proposed service area. Fla. Admin. Code R. 59C-1.008(2)(e)3. While Nemours’ own health planner agreed that the absence of a PHT program in OTSA 3 is not itself a basis for finding need, Nemours nevertheless argues that this rule is inapplicable in this proceeding because the title to this subsection of the rule is “Comparative Review” and a portion of this subsection addresses competing applications in the same cycle. As detailed further in the Conclusions of Law section herein, this interpretation is unconvincing and rejected. AHCA interprets this rule provision to apply to those batched applications submitted without the submission of a competing application in the same batching cycle, as with Nemours in this proceeding. Nemours initiated its cardiac catheterization and cardiac surgery program in June/July 2016. In its PHT application, Nemours projected that it would meet or exceed the rule minimum required volumes of 200 cardiac catheterizations and 125 open-heart surgery cases by the end of 2017. Actual volumes achieved by Nemours in CY 2017 were 97 open-heart cases and 196 cardiac catheterizations. The incidence of PHLT is extremely low. During the four calendar years, 2013 through 2016, there were only 16 PHLT transplants performed nationwide. Only one Florida resident received a PHLT during that four-year period, and that was performed in Massachusetts. Also during that four-year period, only three Florida residents were registered for PHLT. There is no evidence in this record as to why two of the three registered Florida residents did not obtain a PHLT. Based on the national use rate for PHLTs from CY 2013 through CY 2016, Nemours projects that it will perform an average of one PHLT per year. Nemours acknowledges that due to the extremely low incidence of PHLTs, there may be some years that no PHLTs are performed at Nemours. Geographic Access There is no evidence of record that families living in central Florida are currently being forced to travel unreasonable distances to obtain PHT services. Indeed, there are five existing or approved programs within the state, with at least two located very reasonably proximate to OTSA 3. According to the analysis of travel distances for PHT patients living in OTSA 3 contained in the Nemours application (Exhibit 15), only some residents located in Brevard and Indian River Counties are not within 120 miles of an existing PHT program. There was agreement that patients that need a PHT are approaching the end-stage of cardiac function, and in the absence of a PHT will very likely die. Accordingly, it is reasonable to infer that the parents of a child living in central Florida and needing a PHT will travel to St. Petersburg or Gainesville for transplant services rather than let their child die because the travel distance is too far. To the contrary, the evidence in this record from witnesses on both sides, as well as common sense, is that families will go as far as necessary to save their child. The notion that there is some pent-up demand for PHT services among central Florida residents (especially when there is no evidence of a single OTSA 3 patient being turned down or unable to access a PHT) is without support in this record. The parents of four pediatric patients testified at the final hearing. Two testified for Nemours. The other two testified for AHCA and were parents of children that received PHTs at Shands. One of the Nemours witnesses was the parent of a child that has not received a transplant. The other received transplant services at Johns Hopkins All Children’s Hospital in St. Petersburg. The parents of the two Shands patients were representative of the two broad categories of PHT patients. One was a patient with a congenital heart defect that lives in Cocoa Beach (Brevard County). The patient likely had the heart defect since birth, but it was not diagnosed until she was six years old. That patient was asymptomatic at the time of diagnosis but deteriorated over a period of years. While she was first seen at Shands, the family had the time and researched other prominent institutions, including Texas Children’s Hospital, Boston Children’s Hospital, Children’s Hospital of Pittsburgh, and the Mayo Clinic in Rochester, Minnesota. They did this because, like all of the parents that testified, they “would have gone to the ends of the earth” to save their child. This family researched the volumes and experience of the programs they considered and looked for what they felt was the best program for their child, and ultimately chose Shands. It was clear that they felt Shands was the right choice. Their daughter received her heart transplant at Shands, is doing well, and is now considering what college to attend. Additionally, this family did not find the two hours and 35 minute travel time from their home in Brevard County to Shands to be an impediment, and actually consider Shands as being relatively close to their home. This testimony supports the obvious truism that obtaining the best possible outcome for a sick child is the paramount goal of any parent. The other parent witness called by AHCA has a daughter that, on Christmas Eve in 2008, went from perfectly healthy to near death and being placed on life support within a 24-hour period. As opposed to a congenital heart defect, this patient had cardiomyopathy. This family lives in Windermere, a suburb of Orlando. She acquired a virus that attacked her heart. She was initially treated at Arnold Palmer Children’s Hospital where she had to be placed on ECMO. From there, she was safely airlifted to Shands while still on ECMO where, upon arrival, the receiving team of physicians informed the family that she was one of the most critically ill children they had ever seen. After an 11-hour open-heart surgery, a Berlin Heart was successfully implanted and kept her alive for four months until an appropriate donor heart became available. This patient also had an excellent outcome and is now a student at the University of Florida. The following exchange summarizes how the child’s mother felt about the inconvenience of having to travel from the Orlando area to Gainesville: Q If a family in Orlando told you, or in your city of residence told you that their child was critically ill and they were worried about having to travel and potentially spend time in Gainesville to get care, what would you tell them? A Well, I would tell them to just take it a day at a time and – when your child is critically ill, convenience never really comes into your mind. What comes into your mind is how do I help my child live. And so you will go anywhere. And it’s just an hour and a half, it just doesn’t matter. When you are talking about saving your child, it means nothing. It literally means nothing. It is clear from the testimony of these two parents that nothing about having a gravely ill child is “convenient.” It creates great stress, but it was also clear that having an experienced provider was more important than just geographic proximity. The mothers of the two Shands patients persuasively spoke of their concerns about further diluting the volumes of the existing programs that could result from approval of a sixth pediatric heart transplant program in Florida, particularly when there are two other programs that are not that far from the Orlando area.4/ While transplantation is not an elective service, it is not done on an emergent basis. As noted, the number of families affected is, quite fortunately, very small. While having a child with these issues is never “convenient,” the travel issues that might exist do not outweigh the weight of the evidence that fails to demonstrate a need for approval of either application. The Orlando area, being centrally located in Florida, is reasonably accessible to all of the existing providers. Most appear to go to Shands, which is simply not a substantial distance away. The credible evidence is that families facing these issues are able to deal with the travel inconvenience. In addition, Nemours presented evidence regarding the various locations at which they provide services, ranging from Pensacola to Port St. Lucie. Clearly, Nemours sees itself as providing some cardiac services to patients in these locations, but it would also suggest that patients seen at these locations may be referred to NCH for transplant services, which would mean that some patients would be bypassing closer facilities. As observed by AHCA, for Nemours to posit that it is appropriate for patients to travel from Pensacola or Jacksonville to Orlando while asserting that it is not acceptable for patients in Orlando to go to Gainesville or St. Petersburg is an illogical inconsistency. Financial Access Nemours asserts that approval of its proposed programs will enhance financial access to care. Nemours currently serves patients without regard to ability to pay and will extend these same policies to transplant recipients. Approximately half of Nemours’ projected PHTs are to be provided to Medicaid recipients, the other half to commercially insured patients.5/ However, there was no competent evidence of record that access to PHT or PHLT services was being denied by any of the existing transplant providers because of a patient’s inability to pay. Transplant Rates at Shands In its need methodology, Nemours utilized the use rate from OTSA 1 where Shands is located because it is the highest use rate in the state. Despite this, Nemours then asserted that Shands is not performing as many PHTs as it could or should. The Nemours CON applications are not predicated on any argument that their proposed programs are needed because of poor quality care at any of the existing pediatric transplant programs in Florida. Indeed, Dr. Wearden stated his belief that Shands provides good quality care in its transplant programs, and he respects the Shands lead surgeon, Dr. Mark Bleiweis. As evidence of his respect for the Shands PHT program, Dr. Wearden has referred several transplant patients to Dr. Bleiweis at Shands. Despite that position, Nemours argued that the Shands program is unduly conservative and cautious in its organ selection and may have some “capacity” issues due to a few cited instances of apparent surgeon unavailability. These assertions, made by Nemours witnesses with no first-hand knowledge of the operations of the Shands program, are not persuasive. With regard to whether the Shands program is unduly “cautious,” “conservative,” or “picky,” Nemours relied on a document produced by Shands in discovery. Nemours also relied on data reported by Shands to the Scientific Registry of Transplant Recipients (SRTR). The data included a list of all of the organs offered to Shands since the beginning of 2015, the sequencing of the offer of that organ to Shands, whether the organ was transplanted at Shands or elsewhere, the primary and secondary reasons the organ was refused (if refused) and other information. The SRTR exhibit demonstrates that a high number of the organs that are offered are not acceptable for transplant on patients waitlisted at Shands. It also shows that organs that are accepted may have to be examined by many different centers before being deemed potentially acceptable. This demonstrates the extensive level of complexity, nuance, and clinical judgment involved in the decision to accept an organ for transplant in a pediatric patient. Indeed, Dr. Wearden agreed that the decision by a program to accept or turn down an organ involves both clinical expertise and judgment, and that there are many reasons an organ might be turned down, which helps explain why the transplanted percentage of total organs offered nationally is on average, so small. Dr. Wearden chose a few examples of organs that were not taken by Shands to express an opinion that Shands may be unduly conservative in its organ selection. However, this assertion was credibly refuted by Dr. Pietra, a transplant cardiologist and the medical director of the UF Health Congenital Heart Center. Dr. Pietra discussed the complexity of these cases and how simply looking at the SRTR data does not provide enough information to reach Dr. Wearden’s conclusion. An organ that might be acceptable for one patient would not be acceptable for another for a host of reasons. Many more organs are rejected by transplant centers than are accepted. Dr. Pietra credibly opined that being conservative and cautious are important traits for a transplant surgeon, particularly for one that wants the accepted organ to work well for the patient long-term. That does not mean that Shands is rejecting organs when it should have taken them, nor does the SRTR data support the proposition that the Nemours program should be approved because its program may have accepted an organ for a particular patient that Shands might have rejected. Nemours also argues that Shands performs PHTs at a rate lower than the region and the country, and that this should mitigate for the approval of another program. This assertion is predicated on waitlist information reported in the SRTR data. Patients that are placed on the waitlist have different status designations, depending on the severity of their condition. That status may change, up or down, over time. Due to the shortage of organs, until a patient reaches status 1A, he or she is unlikely to be offered an organ. The evidence reflected that Shands puts patients on the PHT organ waitlist at a time earlier than the moment they require the transplant surgery under what is called the “pediatric prerogative.” This helps those patients maintain their status on the list but does not result in organs being provided to less severely ill patients to the detriment of those in greater need. Further, the record evidence supports the finding that Shands waitlists patients because the clinical determination has been made that the child will ultimately require a transplant. This was corroborated by the parent of a Shands PHT patient who testified that when her daughter was placed on the waitlist, Dr. Fricker concluded at that time that her daughter would ultimately need a PHT, even though she was placed on a lower status initially, and it was a few years before the transplant occurred. Transplant surgeon Dr. Victor Morell, of the Children’s Hospital of Pittsburgh, testified that he waitlists his PHT patients not only when they need the procedure performed immediately, but rather when, in his clinical judgment, he determines the patient will ultimately need a PHT. This testimony supports the finding that there is nothing clinically unusual or inappropriate about how the Shands program waitlists patients. Shands realizes that its philosophy, which is contemplated within and permitted under the United Network for Organ Sharing (UNOS) rules, makes its statistics, both in terms of percent of patients transplanted and waitlist mortality, look worse. While Shands’ waitlist mortality may be higher than expected as reflected in the SRTR data, it is still significantly lower than in the UNOS region or the United States. Shands advocates for its patients by their waitlist practices because it believes it helps secure the best outcomes for its patients. It does not indicate need for a new PHT program. Nemours also suggests that there may be a “capacity” problem at Shands because the organ rejection information provided by Shands shows that, during the 3-year period of CY 2015 through CY 2017, there were seven entries showing as either a primary or secondary reason for organ rejection that the surgeon was unavailable. However, this included both adult and pediatric hearts, and further investigation revealed that in only four instances were there potential PHT recipients at Shands. Of those four hearts that were rejected, two were not accepted by any PHT provider, and the two that were accepted were placed with adult transplant patients, not PHT patients. Shands has two PHT transplant surgeons. In very few instances at Shands, an organ was offered but not accepted because the surgeon was not available for one of several reasons. In one instance, there was another transplant scheduled. A surgeon could be ill, could be gone, or may have just completed another long surgery and be too fatigued to safely perform another. Like Shands, Nemours also has two experienced PHT surgeons. Although Dr. Wearden believes that Nemours would endeavor to not reject an organ for this reason, this ambition ignores reality. He cannot guarantee that the same could not or would not happen at Nemours for the same reasons it occasionally occurs at Shands. As explained by Dr. Pietra, when there are only small to medium volume programs, there is not likely to be a sufficient number of surgeons such that this scenario can be avoided entirely. Not Normal Circumstances In both its heart and heart/lung applications, Nemours articulated the following “not normal circumstances” in seeking approval: Florida does not have any approved pediatric heart/lung transplant programs. Florida's only two approved pediatric lung transplant programs have not performed any lung transplant programs in the last two reporting years according to AHCA reporting data. Significantly, there are no pediatric heart transplant or lung transplant programs in AHCA's Organ Transplant Service Area OTSA 3 in which NCH is located-an area of the State with one the fastest growing and youngest populations. Florida has no other pediatric comprehensive, multi-organ thoracic transplant program. Florida has no other pediatric comprehensive, multi-organ thoracic transplant program that is part of a pediatric specific integrated delivery system such as Nemours offers. NCH offers a unique, dedicated model of cardiothoracic care developed at its Alfred I. duPont Hospital for Children (AIDHC) in Wilmington, Delaware and implemented upon the opening of the program at NCH. The key and differentiating element of this Model of Care is a unified team of cardiac clinical and administrative professionals who serve children with cardiac problems in dedicated facilities (the "Cardiac Team"). The Cardiac Team only cares for children with cardiac diagnoses. As such, the Cardiac Team of anesthesiologists, surgeons, cardiologists, nurses, and other support personnel do not "float" to other hospital floors or departments as in a typical hospital setting. This dedicated model of cardiac care allows the Cardiac Team to develop highly specialized knowledge and relationships to provide the best treatment protocols for patients with cardiac conditions. NCH has developed state-of-the art facilities and innovative clinical pathways for the care of the most complex pediatric thoracic patients. NCH has and will bring new opportunities for research in pediatric cardiology, cardiac surgery, and pulmonary medicine, particularly clinical translational and basic research into the linkages between childhood obesity and cardiac conditions. Nemours operates a regional network of clinics in Florida, with primary locations in Pensacola, Jacksonville, and Orlando, that will operate in partnership with NCH for the appropriate regional referral of patients in Florida for pediatric thoracic care. NCH can reduce the out-migration of pediatric, thoracic transplant patients from OTSA 3 to other parts of the State as well as the out-migration of these patients to other out-of-state transplant programs. Similarly, NCH will reduce the outmigration of organs donated in Florida to other states ensuring that Florida recipient patients are first priority for organs donated in Florida. NCH has in place the infrastructure, facilities, and resources to seamlessly add thoracic transplant services to its existing comprehensive cardiac surgery program. Additional needed staff are already being recruited to this program. As a result, the project has minimal incremental cost that will need to be incurred. Total project costs are, therefore, estimated to be $715,425.00. In addition, according to Nemours, an additional “not normal” circumstance has emerged since the filing of the applications: the approval of Nemours’ PLT application in the absence of a PHT program at the facility, which it contends is “a very unusual situation.” Noteworthy about these purported reasons for approval are that: (1) none of them are specifically directed at a unique circumstance relating to a need for another PHT program; and (2) most of them are either a recitation of the fact that there is no existing program in the service area or are about Nemours’ capability to provide these services. They are not directed at whether there is a need for its proposed programs. In fact, the main thrust of Nemours’ case was directed at proof regarding its capabilities. But the flaw in this theme is best demonstrated in the testimony of Dawn Tucker, the last witness called by Nemours. Ms. Tucker is the cardiac program administrative director for Nemours. When asked why she supported the proposed program, she talked about the experience of the team, a desire to care for sick patients, an organization (Nemours) that financially supports the program, and the network of centers that Nemours has in Florida. These factors address why Nemours “wants” these CONs. None of them addresses the threshold issue of whether there is a “need” for these programs in OTSA 3. More specifically, the first, third, and fourth bullet points are all based on the absence of a program in OTSA 3. By rule, that is not a basis for establishing need. Fla. Admin. Code R. 59C-1.009(2)(e)3. AHCA appropriately rejected the absence of a program in OTSA 3 as the sole basis upon which need for the proposed projects could be established. The second bullet point relates to the pediatric lung transplant application that is not at issue in this matter. The fifth and sixth bullet points relate to the Nemours integrated model of care. But again, this does not address whether there is a need for the proposed programs. The fact that Nemours has an employed-physician model is not unique or “not normal.” AHCA considered the information regarding the model of care and correctly noted that the model of care does not itself enhance access or improve outcomes. It should be noted that Shands’ doctors are employed by the University of Florida. In addition, the reliance on this model does not guarantee a robust program. This bullet point references the much older and more established Alfred I. duPont Hospital for Children in Wilmington, Delaware, that is touted as the model for Nemours. Nemours presented evidence relating to its more established hospital in Delaware that also provides PHT services. However, the PHT program at duPont is a low-volume program, performing only one PHT in 2016. None of the managed- care companies that recognize Shands as a center of excellence also recognizes the duPont Hospital as such. One of the companies--Lifetrac--acknowledges duPont as a “supplemental” program, whereas Shands is one of its “select” programs. This demonstrates that simply having the financial resources of the duPont Foundation or the model of care used by that organization does not guarantee high volumes or success. The “not normal circumstance” bullet points regarding Nemours’ facilities, research, and other infrastructure similarly do not demonstrate need. Otherwise, a hospital could obtain a CON for a new program by spending the money in advance and then demanding approval based upon those expenditures. AHCA recognized that Nemours had recruited some very qualified clinicians, but correctly noted that that does not create or evidence need for the proposed programs. The remaining bullet point asserts that approval of the PHT and PHLT programs could reduce outmigration of both patients and organs. By definition, because neither of these transplant programs exists in OTSA 3, all patients leave OTSA 3 for these services. Again, that alone does not establish need, nor is it automatically a “not normal” circumstance. As discussed herein, Nemours has not demonstrated a sufficient need or an access problem that justifies approval of either application. With regard to the outmigration of organs from Florida, Nemours has argued that Florida is a net exporter of organs and that this is a “not normal” circumstance justifying approval of its application. However, organs harvested in one state are commonly used in another. There is nothing unusual or negative about that fact. Indeed, Dr. Wearden agreed that in his experience, this is a common occurrence. There is a national allocation system through UNOS and this sharing, as explained by Dr. Pietra, facilitates the best match for organs and patients. UNOS divides the country into regions for the purpose of allocation of donor organs, with Florida being one of six states in Region 3. The evidence of record did not establish that approval of the Nemours applications would result in the reduction of organs leaving Florida, or even that such would be a desirable result. Nemours also argued at hearing that approving their applications would increase the number of donor organs that are procured and transplanted in Florida. Nemours suggested that its programs would increase public awareness and implied that it would accept organs for future patients that surgeons at other programs turn down. However, these arguments are purely conjectural and are rejected. No record evidence exists which demonstrates that a Nemours program would increase the supply of organs in Florida. Indeed, Nemours presented no such relevant data or statistical evidence in its applications to demonstrate that this will occur. Finally, Nemours argues that its PHT and PHLT applications should be approved because it does not make sense for AHCA to have approved the PLT program but denied the other two applications. Nemours goes on to note that while there are hospitals in the country that do PHTs but not PLTs, there are no hospitals that do lungs but not hearts. Regardless of whether that is true, Florida law separates these three services into separate CON applications, which are reviewed independently. The wisdom of the rule is not at issue in this proceeding. Regardless of any overlap in the skill sets required to perform these procedures, approval of the pediatric lung transplant application does not determine need for pediatric heart or pediatric heart/lung programs. Nemours failed to establish that “not normal” circumstances currently exist that would warrant approval of either the PHT or PHLT programs. Nor did Nemours credibly demonstrate any other indicators of need for its proposed programs. Section 408.035(1)(c): The ability of the applicant to provide quality of care and the applicant’s record of providing quality of care. The parties stipulated that Nemours is a quality provider. However, AHCA maintains that this criterion is in dispute to the extent that center transplant volume as a result of Nemours’ approval would lead to or correlate with negative patient outcomes. Nemours failed to demonstrate that it would achieve the volumes it projected unless it takes significant volumes from other Florida providers.6/ Approval of Nemours will not create transplant patients that do not exist or are not currently able to reasonably access services. While Nemours has assembled a team of professionals with varying levels of transplant experience, it has not been demonstrated that it will achieve volume sufficient to reasonably assure quality care.7/ Section 408.035(1)(e): The extent to which the proposed services will enhance access to health care for residents of the service district. Approval of the Nemours PHT and PHLT programs would unquestionably improve geographic access to those services for the very few residents of OTSA 3 that need them. However, given the extreme rarity of pediatric heart and heart/lung transplants, approval of the Nemours programs would not result in enhanced access for a significant number of patients. Moreover, there was no credible non-hearsay evidence presented at hearing that any resident of OTSA 3 that needed PHT or PHLT services was unable to access those services at one of the existing PHT programs in Florida or, for PHLT, at a facility elsewhere. Based upon persuasive evidence at hearing, there is also clearly a positive relationship between volume and outcomes. As with any complex endeavor, practice makes perfect. In this instance, maintaining a minimum PHT case volume provides experience to the clinicians involved and helps maintain proficiency. According to the credible testimony of Dr. Pietra, programs should perform no fewer than 10 PHTs per year. “If you can stay above 10, then your program is going to be exercised at a minimum amount to keep everybody sort of at a peak performance.” The clear intent of the minimum volume requirement of 12 heart transplants per year contained in rule 59C- 1.044(6)(b)2. is to ensure a sufficient case volume to maintain the proficiency of the transplant surgeons and other clinicians involved in the surgical and post-surgical care of PHT patients. In addition, pediatric transplant programs are measured statistically based on outcomes, such as mortality and morbidity. Because of this, the loss of even one patient in a small program can be devastating to that hospital’s mortality statistics. As such, small programs may become less willing to take more complicated patients. In a perverse sort of way, adding more programs that dilute volumes may decrease, rather than increase, access because of the fear a small program might have for taking more complex patients. Adequate case volume is also important for teaching facilities, such as Shands, to benefit residents of all the OTSAs by being able to train the next generation of transplant physicians. The mothers of the two Shands patients that testified made note of the complexity of their daughters’ conditions and how their cases were used for training purposes. There was no persuasive evidence of record that approval of the Nemours applications would meaningfully and significantly enhance geographic access to transplant services in OTSA 3. The modest improvement in geographic access for the few patients that are to be served by the two programs is not significant enough to justify approval in the absence of demonstrated need. There is no evidence that approval of the Nemours applications will enhance financial access nor that patients are not currently able to access PHT or PHLT services because of payor status. Section 408.035(1)(g): The extent to which the proposal will foster competition that promotes quality and cost- effectiveness. It is clear that establishing and maintaining a transplant program is expensive. Given the limited pool of patients, the added expense of yet a sixth Florida program is not a cost-effective use of resources. This criterion also relates to the Nemours position that AHCA should approve the PHT and PHLT applications simply because the PLT application was approved, and it would not be cost-effective for Nemours unless the PHT and PHLT applications were also approved. However, each of these applications must rise or fall on its own merit. As of the hearing, Nemours had not yet implemented its PLT program. Given the absence of need for either the PHT or PHLT programs, the cost-effective solution might be for Nemours to reconsider implementation of the PLT program. 408.035(1)(i): The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent. AHCA agreed at hearing that Nemours satisfies section 408.035(1)(i). Nonetheless, Nemours provides a very high level of Medicaid services, and projects a high-level volume related to Medicaid patients and charity care patients. As noted, approximately half of the PHTs projected by Nemours will be performed on Medicaid patients. Conformance with this criterion would mitigate toward approval had there been persuasive evidence that Medicaid and medically indigent patients are currently being denied access to PHT and PHLT services. However, no such evidence was presented.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying CON Application Nos. 10471 and 10472 filed by The Nemours Foundation, d/b/a Nemours Children’s Hospital. DONE AND ENTERED this 31st day of July, 2018, in Tallahassee, Leon County, Florida. S W. DAVID WATKINS 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 31st day of July, 2018.
Findings Of Fact Application Process Humhosco is a wholly owned subsidiary of Humana, Inc. Humhosco owns Humana Hospital Brandon and other hospitals in Florida. The record does not disclose thee number of such hospitals or whether Humhosco owns other assets. On February 26, 1988, Humhosco submitted to HRS a letter of intent to apply for a certificate of need for open heart services at Humana Hospital Brandon. The letter of intent included a certificate dated February 26, 1988, authorizing Humhosco to file the application for the project estimated to cost nearly $2 million, making available "sufficient funds" for the project, certifying that Humhosco shall accomplish the project within the time allowable by law at or below the costs stated in the application, and certifying that Humhosco shall license and operate the facility. The certificate was signed by Alice F. Newton, as Secretary of Humana, Inc. She certified that the representations contained in the preceding paragraph were resolutions of the Board of Directors of Humana, Inc. approved on February 26, 1989. On or about March 14, 1988, Humhosco submitted to HRS an application for a certificate of need to install and operate an open heart center at Humana Hospital Brandon. The projected cost was about $1.9 million. The application included a certificate dated March 16, 1988, containing resolutions similar to those contained in the certificate of February 26, 1988. The certificate was again signed by Alice F. Newton, but this time in her capacity as Secretary of Humhosco. The resolutions, which were dated as of March 16, 1988, were adopted by the Board of Directors of Humhosco. The application contained no financial statement of Humhosco. Instead, the application contained an audited financial statement for "Humana Hospital- Brandon (a division of Humhosco, Inc., a wholly-owned subsidiary of Humana Inc.)." The financial statement, which was for fiscal year ending August 31, 1987, reflected an examination of the financial records of Humana Hospital Brandon, not Humhosco. The financial statement disclosed a shareholder's equity of about $24 million and net income of about $6.2 million based on net revenues of about $47 million and income before income taxes of about $12.2 million. The record does not explain the basis for a shareholder's equity in a division of the corporation in which it owns shares. However, nothing in the record suggests that the financial statement is mislabelled. The financial statement appears to reflect the operations and net worth of a division of Humhosco, not Humhosco itself. The financial statement is of little value in assessing the financial condition of Humhosco. Nothing in the record supports an inference that Humhosco's other hospitals, as well as any other operating assets that Humhosco might own, are profitable or, if unprofitable, whether their losses are exceeded by the profits of Humana Hospital Brandon. By letter dated April 14, 1988, HRS requested additional information from Humhosco. The letter requested, among other things, a financial statement for the prior year and an original certificate rather than a copy. HRS never commented on the fact that the certificate accompanying the letter of intent evidenced resolutions from the corporate parent of the applicant or that the financial statements were of a division of the applicant. By letter dated May 12, 1988, Humhosco responded to the above- described omissions letter. In its response, Humhosco provided the earlier financial statement, which was for Humana Hospital Brandon and not Humhosco. The letter did not include any material information regarding either certificate. By letter dated July 11, 1988, HRS informed Humhosco of its intent to issue Certificate of Need 5537 for the establishment of the open heart program described in the application. The accompanying State Agency Action Report, which was dated July 8, 1988, recommended that the certificate of need be issued in its entirety. The report stated that the need methodology described by Rule 10-5.011(1)(f) justified seven open heart programs in District VI, which has only six such programs, and the Humhosco proposal was in substantial compliance with all criteria. The Hospital Humana Hospital Brandon is a 220-bed general hospital in Brandon, which is in eastern Hillsborough County. Humana Hospital Brand on is fully accredited by the Joint Commission of the Accreditation of Health Care Organizations. The hospital, which is a Level II trauma center with eastern Hillsborough County as its catchment area, contains 16 intensive-care and cardiac-care beds and 35 progressive-care beds, in addition to its regular medical-surgery beds. The hospital offers a wide range of services, including medicine, pathology, anesthesiology, radiology, neurology, intensive care, and emergency care available at all times for cardiac emergencies. The hospital provides cardiac catheterization services through its cardiac catheterization lab and noninvasive cardiographics lab. Open heart surgery is cardiac surgery during which a cardiopulmonary bypass procedure is used. Cardiac catheterization is a diagnostic/therapeutic procedure used in connection with heart and circulatory conditions. Coronary angioplasty is the expansion of narrowed segments of the coronary vessels. The proposed open heart suite would be adjacent to the existing cardiac catheterization lab, and the two facilities would share the same recovery/support area. The proposed program would provide a wide range of procedures, including the repair or replacement of heart valves, repair of congenital heart defects, cardiac revascularization, repair or reconstruction of intrathoracic vessels, and the treatment of cardiac truama. The program would have the ability to implement and apply circulatory assist devices such as the intra- aortic balloon assist and prolonged cardiopulmonary partial bypass. Need District and State Health Plans The 1985 District VI Health Plan reports that most cardiac surgeries are open heart with the most common of these being coronary bypass surgery. The plan acknowledges that an important use of cardiac catheterization is evaluation for open heart surgery. According to the plan, open heart surgery, particularly coronary bypass surgery, has been controversial with respect to its risk- and cost- effectiveness and the fairness of its distribution among the entire population. Noting a decline in procedures in District VI from 1983 to 1984, the plan concluded that the application of the present rule methodology could exaggerate need if the decline continued. Otherwise, however, the proposed program satisfied the policies of the district plan broadly relating to need. The State Health Plan stated that an inverse relationship exists between the volume of open heart procedures and surgical death rates. The state plan added, however, that no clear agreement exists as to the minimum number of procedures necessary to maintain staff skills. The plan endorsed the rule requiring that a new program project a minimum of 200 procedures annually within three years of opening. The State Health Plan reported the controversy concerning the efficacy of open heart procedures, at least at their current rate. The plan concluded that further study would be required before the issue could be resolved. The plan stated that new types of cardiac catheterization procedures may replace some open heart surgery, "while necessitating the availability of open heart programs on standby basis within the same facility." The plan also anticipated a reduction in the rate of open heart surgery with the introduction of new procedures, such as balloon angioplasty, clot-dissolving substances, and calcium blockers. The plan noted the recommendations of two groups that cardiac catheterization laboratories be located only in facilities providing open heart surgery. The plan suggested that catheterization laboratories without connected open heart programs would suffer lower utilization rates than catheterization laboratories with open heart programs. The State Health Plan concluded by establishing an objective "to maintain an average of 350 open heart surgery procedures per program in each district through 1990." HRS Rules Rule 10-5.011(1)(f), Florida Administrative Code, sets forth the HRS numeric need methodology. Rule 10-5.011(1)(f)8 provides a formula to estimate the number of open heart procedures for the horizon year, which, in this case, is 1990. Rule 10-5.011(1)(f)11 prohibits the approval of new open heart programs unless certain conditions are met, including satisfying the requirement of Rule 10-5.011(1)(f)5.d that 200 procedures annually be performed within three years after commencement of the service. The proposed open heart program would generate a minimum of 200 adult open heart procedures annually within three years after commencement. Ultimately, the program could handle as many as 500 procedures annually. Under the formula contained in Rule 10-5.011(1)(f)8, the estimated number of open heart procedures in District VI is 2555 in 1990, which is when the proposed program would become operational. The projected population of District VI on January 1, 1990, is 1,563,354 persons. For the 12-month period ending two months prior to the deadline for letters of intent for the subject batching cycle, the use rate per 100,000 persons in District VI was 163.45. This figure is based on a population of 1,469,572 persons residing in District VI as of July 1, 1987, and 2402 open heart procedures performed during calendar year 1987. (The number of procedures includes 1050 procedures performed at Tampa General for the one-year period ending September 30, 1987, rather than calendar year 1987.) Rule 10-5.001(1)(f)11.b requires that the projected number of procedures in 1990 be divided by 350 in order to generate the number of programs needed to exist in 1990. The result of this calculation is that seven open heart programs are needed in District VI. That means that there is a net need for one program because there are presently six existing and approved open heart programs in District VI. However, Rule 10-5.011(1)(f)11.a.I prohibits the approval of any new open heart programs unless "each existing and approved" program is "operating at" and "expected to continue to operate at" a minimum of 350 adult open heart cases annually. The meaning of this rule is unclear, and HRS apparently interprets it merely to require that all existing programs average 350 procedures annually at the time of determination of the actual use rate. Another interpretation of the rule is that each existing and each approved program must be operating at the requisite rate before new programs could be approved. This interpretation is impractical because approved programs that are not yet in operation are not operating at any rate. If the intent of the rule were to prohibit the establishment of more than one open heart program at a time, HRS could have simply stated as much. The most likely interpretation is one that addresses the universally recognized relationship between volume of open heart procedures (up to a certain level) and patient mortality. The rule requires that each existing and approved facility in the district be operating at 350 procedures annually before new open heart programs are licensed. The rule does not authorize averaging the total number of procedures among the licensed facilities in a district. The inverse relationship between the number of procedures and surgical deaths is not dependent upon an average number of procedures performed in a geographical area. The safety of an open heart patient is dependent upon the actual number of open heart procedures being performed at the hospital that he or she has selected for open heart surgery. The presence in District VI of a hospital performing 1400 open heart procedures annually is of no relevance to the patient who has unwittingly selected a hospital in the same district that performs only, say, 50 such procedures annually. The six existing and approved open heart programs in District VI are identified below by facility, location, and numbers of procedures in 1987 and the first six months of 1988. Facility County 1987/1988 Procedures Tampa General Hillsborough 1050/714 St. Joseph's Hillsborough 887/514 University Community Hillsborough 0/0 Manatee Memorial Manatee 0/70 L. W. Blake Manatee 0/0 Lakeland Regional Polk 465/292 TOTAL DISTRICT VI PROCEDURES--1987 2402/1590 The 1988 procedures for Manatee Memorial cover the period of February, when the program became operational, through June. The State Agency Action Report indicates that Manatee Memorial is an approved but not yet existing program, although the program had already accounted for 70 procedures by the time of the report. The reason for this apparent discrepancy is that HRS uses the 1987 data used for calculating the use rate when determining the status of other programs. HRS offered little explanation of why it used 1987 data for determining in 1988 whether other programs were existing. Rule 10-5.011(1)(f), Florida Administrative Code, which covers open heart programs, does not define "approved and existing programs" or establish the time at which the status of a program should be determined. However, given the critical role of patient safety in the licensing process, the rule does not justify the reference to obsolete data. The Manatee Memorial open heart program was existing and approved at the time of the letter of intent and application of Humhosco and the State Agency Action Report. It was not then operating at 350 open heart procedures annually. Its approximate annualized rate of 168 procedures is materially below even the annual rate of 200 procedures often cited as the minimum number at which the mortality rate levels out. Additionally, there was no evidence that Manatee Memorial would attain such a volume of open heart procedures. Conclusions Regarding Need According to the numeric need methodology, exclusive of Rule 10- 5.011(1)(f)11.a.I, District VI could support an additional open heart program. Although in the long run the rate of open heart procedures may decrease for the reasons set forth above, the rate of such procedures will probably increase at least through 1990 and probably several years thereafter. For reasons set forth elsewhere in this recommended order, the Humana Hospital Brandon program would successfully satisfy this need. However, the requirement of Rule 10-5.011(1)(f)11.a.I has not been met, and thus need under the rule does not exist. Of the six current open heart programs in District VI, three performed no procedures in 1987. During the first six months of 1988, one of these three programs became operational, but the other two had yet to perform their first procedure. Although the first-year rate of procedures at Manatee Memorial was not insubstantial, the program is not operating at and expected to continue to operate at the minimum annual rate of 350 procedures set forth in the rule. The likelihood of the Manatee Memorial program attaining such a rate is especially difficult to predict in view of the unknown consequences of the initiation of another open heart program in Manatee County and another elsewhere in District VI. On balance, the proposed program at Humana Hospital Brandon is not needed or authorized due to the existing volume of procedures at Manatee Memorial as of the time of the application and approval and the adverse effect of reduced volumes upon patient safety. Rule 10-5.011(1)(f)11.a.I makes it clear that District VI needs time to absorb the recently approved open heart programs before a new one should be established. Quality of Care Humhosco has the ability to provide high quality of care and has done so in the past. An open heart program at Humana Hospital Brandon would improve the quality of care at the hospital. The new program would have limited effect upon the hospital's trauma services due to the limited number of trauma-related open heart procedures. However, the new program would complement the cardiac catheterization lab at the hospital. The addition of an open heart program would permit Humhosco to add cardiac angioplasty services in the cardiac catheterization lab at the hospital. Continuity of care and patient safety and convenience would be enhanced by the establishment of an open heart program at Humana Hospital Brandon. Strong physician support exists for an open heart program at Humana Hospital Brandon. Many existing staff persons already have the necessary skills and experience to participate in the open heart program. The staff includes 10 cardiovascular surgeons certified by the Medical Board of Thoracic Surgery or board-eligible for certification and three board-certified or board-eligible anesthesiologists trained in open heart surgery. Humhosco would add the additional staff needed to operate the proposed program. Humana Hospital Brandon has the capacity to accommodate the projected patient volume from the open heart program. Service Accessiblity Rule 10-5.011(1)(f)4.a provides that open heart programs shall be available within a maximum automobile travel time of two hours under average conditions for at least 90% of the district's population. The two-hour standard reflects the fact that open heart surgery is a tertiary service that is ordinarily performed on a scheduled rather than emergency basis. Hillsborough County is the largest county within District VI. The growth rate of eastern Hillsborough is higher than the growth rate of the remainder of the county. No open heart program is presently located in eastern Hillsborough County. A program at Humana Hospital Brandon would reduce the travel time for the persons living in eastern Hillsborough County. However, the two-hour standard is presently met in District VI, and the improvement in geographical access resulting from the establishment of a program at Humana Hospital Brandon is not substantial. The proposed program would satisfy the requirements of Rule 10- 5.011(1)(f)4.b and c regarding hours of operation and waiting periods. Humhosco has projected for the open heart program a payor mix of 55% Medicare, 2% Medicaid, and 5% indigent. If these projections were realized, Humhosco would achieve the objective of making open heart surgery available to these classifications of patients. Humhosco's record of serving these patient classifications at Humana Hospital Brandon suggests that these projected goals would be achieved. Financial Feasibility The immediate financial feasibility of the proposed project is good. The source of construction funds is a reasonable mix of 25% equity and 75% debt. The borrowed funds will come from Humana, Inc., which has ample resources to make a loan of this magnitude. The terms are 10 years at 12% with 120 equal monthly payments of $20,575.89 principal and interest. The availability of the equity portion of construction costs, which amounts to a little over $475,000, is uncertain due to the lack of information concerning the financial condition of the applicant. It is unlikely, however, that the unavailability of any or all of these funds would interfere with the project. Humana, Inc. has in any event committed by resolution to make available to the applicant sufficient funds to accomplish the project. The long-term financial feasibility of the proposed project is good. Even after total interest payments of about $168,000 and $158,000 in the first two years of operation, Humhosco projects, based on reasonable assumptions, that the open heart program would produce after-tax income of about $250,000 on first-year gross revenues of about $6.2 million and $345,000 on second-year gross revenues of about $7 million. Cost Effectiveness The implementation of an open heart program at Humana Hospital Brandon would encourage competition among health care providers of open heart services. Humhosco projects the average charge per open heart admission when the program would open in 1990 to be $29,000. This figure is about $3600 less than the average charge per open heart admission at Tampa General in 1987 and compares favorably with the charges of other providers in the area. In the long term, the effect of an open heart program at Humana Hospital Brandon could have an adverse effect on cost effectiveness if the program at Tampa General lost substantial volume due to the presence of this competition. Tampa General is a major provider of medical services to the medically indigent. Although publicly supported, Tampa General expends more on indigent-related costs than it receives in public funds for the medically indigent. Tampa General therefore must subsidize its unreimbursed indigent services with revenues from paying patients. In 1980, after a period of serious financial strains, Tampa General commenced a modernization program to attract paying patients. The program, together with a $160 million bond issue and new marketing efforts, has significantly improved the financial condition of the hospital. The approval in the past of new open heart programs in the area has coincided with the reduction of open heart procedures at Tampa General. In fiscal year ending 1983, Tampa General performed 1671 procedures. The following year, during which St. Joseph's began performing open heart surgery, Tampa General performed 878 procedures. In fiscal year ending 1985, Tampa General performed 802 procedures. The following two years, during which no new programs became operational, Tampa General performed 1050 and 1428 (projected) procedures, respectively. Undoubtedly, a new open heart program at Humana Hospital Brandon would have some effect on existing programs, including that at Tampa General. However, the record does not support a finding that the establishment of an open heart program at Humana Hospital Brandon would have a more lasting effect upon the program at Tampa General than did the other programs established in recent years. Other Factors The record does not demonstrate that there are less costly, more efficient, or more appropriate alternatives to the in-patient services proposed in the subject application. With one exception, existing in-patient facilities providing open heart services are being used in an appropriate and efficient manner. The exception is that there is nothing in the record to suggest that the open heart programs at Manatee Memorial, University Community, and L. W. Blake are being utilized efficiently. To the contrary, the only program in existence at the time of the application was not operating at the optimal minimum level. The costs and methods of proposed construction are reasonable and appropriate. There is nothing in the record to suggest that practical alternatives exist to the construction program contemplated by Humhosco. Open heart patients will not experience serious problems in obtaining in-patient care if the proposed application is not approved. There is nothing in the record to suggest that joint, cooperative, or shared resources could be used to provide the open heart services for which Humhosco has applied. The proposed program would not have any significant effect on research and educational facilities or health professional training programs.
Recommendation Based on the foregoing, it is RECOMMENDED that a Final Order be entered dismissing the petition of University Community Hospital in Case No. 88-4366 on the grounds that it dismissed its petition, and denying the application of Humhosco for Certificate of Need 5537. DONE and ENTERED this 18th day of April, 1989, in Tallahassee, Florida. ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of April, 1989. APPENDIX Treatment Accorded proposed Findings of Humhosco and HRS 1-29. Adopted or adopted in substance. 30. Rejected as against greater weight of the evidence to the extent that the requirement of 350 procedures at each facility is part of the numeric need methodology. 31 and 33. Adopted in substance. However, the resulting determination of need or no need is tentative. Rule 10-5.011(1)(f)11 provides a general prohibition against the establishment of programs under normal circumstances even though, under the other portions of the rules, there would otherwise be a numeric need. 32. Adopted. Rejected as legal argument. To the extent factual, rejected as against the greater weight of the evidence. Adopted in substance. Rejected as unnecessary. 37-38. Rejected as subordinate. Adopted in substance at least as to the maintenance or slight increase of the present use rate for the immediate future. This fact does not justify a deviation from the rule requirement of the historic use rate, which in any event would justify another program. Nor does this fact justify a not normal condition for the reasons set forth in the recommended order. It should be noted that Humhosco did not offer evidence to this effect at the hearing for either of these improper purposes. This fact is only relevant in assessing the impact of the establishment of the proposed project upon existing providers, especially Tampa General and, to a lesser extent due to the greater amount of speculation involved, the new providers such as Manatee Memorial. Rejected as unsupported by the greater weight of the evidence. An increase in the number of programs has historically been accompanied by an increase in the number of procedures. It is conjecture whether or to what degree the addition of programs caused such an increase. 41-45. Adopted in substance. 46-48. Rejected as subordinate. 49-52. Adopted or adopted in substance. 53-55 and 60. Rejected as legal argument. 56-58 and 61. Adopted or adopted in substance. 59. Rejected as recitation of evidence. 62-64. Rejected as subordinate. 65. Rejected as legal argument. 66-69. Adopted. 70 and 72. Rejected as unsupported by the greater weight of the evidence. 71. Rejected as irrelevant. 73-76. Rejected as subordinate. Concerning the "overcrowded" conditions at Tampa General, the evidence showed only that the Tampa General program was, at times, quite busy, but not overutilized. The periodic high level activity at Tampa General is subordinate to the findings in the recommended order concerning the limited impact upon Tampa General of the approval of the proposed project. 77. Adopted in substance. 78-82. Rejected as subordinate. 83. Adopted in substance. 84-86. Rejected -as subordinate. Rejected as unsupported by the greater weight of the evidence. The proposed payor mix is reasonable insofar as providing access to the medically indigent and Medicaid patients. The record is unclear, however, that the approval of the application would improve the existing access of such patients to open heart services. Adopted in substance. 89 and 91. Rejected as subordinate. 90. Adopted, except that the last sentence is rejected to the extent that it suggests that Humhosco's commitment to financial access is greater than the commitment of existing providers. 92-94. Adopted. 95-96. Rejected as irrelevant. A hospital has no financial strength. A lender or investor assesses the legal entity that owns or operates the hospital. The net worth and profitability of the hospital may have a material impact on the net worth and profitability of the owner or operator of the hospital. However, it is impossible to make that determination without assessing the assets, liabilities, profits, and losses of the legal entity and not simply one of its assets. The immediate financial feasibility may be inferred by the activity of Humana, Inc. with respect to the proposed project. Rejected as legal argument. Adopted in substance. 99-100 and 108. Adopted. 101-107. Rejected as subordinate and cumulative. 109 and 123. Rejected as legal argument. 111-122. Adopted in substance. 123. Rejected as legal argument. and 126. Adopted. and 127-128. Rejected as subordinate. Adopted in substance. Rejected as cumulative. 131-133. Rejected as cumulative and, for the purpose offered, irrelevant. 134-137. Adopted in substance. 138-150. Rejected as subordinate. Treatment of Proposed Findings of Tampa General 1-3. Adopted. Rejected as legal argument and, as to the policy of HRS, irrelevant insofar as such policy might deviate from the clear requirements of the statute. First two sentence rejected as legal argument. Remainder adopted. 6-7. Rejected as legal argument except that last sentence of Paragraph 7 is adopted. First two sentences adopted. Remainder rejected as irrelevant. Adopted in substance. 10-11. Adopted. 12. Rejected as legal argument and, to the extent factual, against the greater weight of the evidence. 13-14. Adopted in substance. 15-16. Rejected as unnecessary. 17. Rejected as against the greater weight of the evidence. 18-20. Adopted in substance. Adopted insofar as Humhosco provides quality cardiac care services at Humana Hospital Brandon without an open heart program. Remainder rejected as against the greater weight of the evidence. Rejected insofar as the proposed finding suggests that a slight improvement in geographic accessibility should, as a matter of law, be ignored in this case. Adopted in substance if, like the proposed finding in Paragraph 19 concerning trauma-center status, this proposed finding means only that the slight improvement in geographic accessibility is alone insufficient to justify granting the certificate of need. Rejected as subordinate. 24-25. Rejected as recitation of evidence and subordinate. Rejected as unsupported by the greater weight of the evidence. Adopted. 28-29. Adopted in substance. Rejected as irrelevant given the interpretation adopted in the recommended order concerning the meaning of Rule 10-5.011(1)(f)11.a.I. Adopted in substance. 32-33. Rejected as unsupported by the greater weight of the evidence. 34. Rejected as subordinate. 35-40. Rejected as unsupported by the greater weight of the evidence. 41-42. Rejected as unsupported by the greater weight of the evidence and subordinate. Treatment Accorded proposed Findings of St. Joseph's 1-4. Adopted or adopted in substance. First sentence adopted except that the tax status of Humhosco as a "holding company" is rejected as a legal conclusion, irrelevant, and unsupported by the greater weight of the evidence. Second sentence adopted. Third sentence rejected as irrelevant. Third sentence rejected as a legal conclusion, irrelevant, and unsupported by the greater weight of the evidence, although it appears to be true that the identities of the persons occupying the named positions are the same between the two companies. Last sentence rejected as irrelevant. Adopted. Rejected as irrelevant. Adopted. Rejected as irrelevant. 10-13. Rejected as legal argument and unnecessary, given the finding in the recommended order that, even ignoring the additional beds that have been approved at Humana Hospital Brandon, the hospital is not overutilized. 14-15 and 17 and 19. Rejected as legal argument. 16. Rejected as subordinate. 18. Adopted in part and rejected in part. The existence of a cardiac catheterization lab does not mandate the authorization of an open heart program. However, the record in this case supports the finding that the addition of an open heart program would complement existing services in the cardiac catheterization lab, and nothing in the law prohibits the consideration of such a factor. 20-21. Rejected as irrelevant. See Paragraph 18 above. Rejected as irrelevant. Rejected as legal argument. Rejected as unsupported by the evidence. 25-26. Rejected as subordinate to the finding contained in the recommended order that the status as a trauma center is not a significant factor in considering the subject application. 27-28. Rejected as legal argument. 29-30. Adopted in substance. 31-33. Rejected as recitation of evidence. 34. Rejected as against the greater weight of the evidence. 35-39. Rejected as subordinate. 40. Adopted in substance. 41-49. Rejected as subordinate. 50. Rejected as irrelevant. 51-52. Rejected as against the greater weight of the evidence. 53-55. Rejected as subordinate. 56. Rejected as legal argument. 57-58. Rejected as recitation of testimony. Rejected as legal argument. Adopted. 61-69. Rejected as unnecessary. Rejected as legal argument. Adopted except that the last sentence is rejected as legal argument. Rejected as legal argument. Rejected as recitation of testimony. Rejected as legal argument. Adopted in substance. 76-78. Rejected as recitation of evidence. COPIES FURNISHED: Ivan Wood, Esquire Sam Power Wood, Lucksinger & Epstein Clerk Four Houston Center Department of Health and 1221 Lamar, Suite 1440 Rehabilitative Services Houston, TX 77010 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Radey, Esquire Elizabeth McArthur, Esquire Gregory L. Coler Aurell, Fons, Radey & Hinkle Secretary Post Office Drawer 11307 Department of Health and Tallahassee, FL 32302 Rehabilitative Services Tallahassee, FL 32399-0700 Cynthia S. Tunnicliff, Esquire Carlton, Fields, Ward, Emmanuel, Smith & Cutler, P.A. John Miller Drawer 190 General Counsel Tallahassee, FL 32302 Department of Health and Rehabilitative Services 1323 Winewood Boulevard John Rodriguez, Esquire Tallahassee, FL 32399-0700 Assistant General Counsel 2727 Mahan Drive Fort Knox Executive Center Tallahassee, FL 32308 James C. Hauser, Esquire Joy Thomas, Esquire Messer, Vickers, Caparello, French and Madsen, P.A. Post Office Box 1876 Tallahassee, FL 32302 =================================================================
Findings Of Fact The Respondent is duly licensed by the Florida State Board of Osteopathic Medical Examiners as an osteopathic physician and surgeon. He has been a licensed practicing osteopathic physician since July, 1962. He has a very sound educational and professional background, and is on the staff of three hospitals. He is presently engaged in the general practice of osteopathic medicine in Dade County, Florida. During March, 1976, the Respondent was associated with the Martin Luther King Memorial Hospital in Miami Beach, Florida. King Memorial is not a full service hospital. Its facilities are approximately the size of an average house. It has x-ray equipment, but it does not have a blood bank. King Memorial is not equipped to perform major surgery. Prior to March 13, 1976, Cycloria Vangates, a 32-year old black female, visited King Memorial. She was pregnant, and she wished to terminate the pregnancy. Miguel Dreize, M.D., who was at that time associated with the Respondent at King Memorial, examined Mrs. Vangates. He had difficulty determining the precise term of Mrs. Vangates' pregnancy, but he estimated that she was at the beginning of the second trimester. Dr. Dreize determined that Mrs. Vangates was anemic. He treated her in order to improve that condition. She was scheduled to have an abortion on the morning of March 13, 1976. Her blood was re-tested prior to the operation being performed, and it was determined that she was in good condition. The Respondent was in charge of performing the abortion. He was assisted by Dr. Dreize. The procedure was performed without significant incident. A small laceration on the cervix on the outside of the uterus was observed, and it was corrected. Immediately after the surgery at approximately 9:30 a.m., Mrs. Vangates' vital signs were good. Her blood pressure was 120/60, and her pulse rate was normal. Within ten to thirty minutes later the patient's blood pressure was again taken by a nurse, and the pressure had fallen drastically to 60/?. The nurse summoned the Respondent. The Respondent placed the patient on i.v. fluid, and administered Aramine. Aramine is a drug which constricts blood vessels, thus reducing the cardiovascular space, causing blood pressure to increase. Aramine can effectively raise blood pressure, but if reduction of blood pressure is caused by a loss of blood, Aramine does nothing to replace the lost fluid. The patient's blood pressure rose, but only to approximately 70/40. Her blood pressure remained fairly stable at that rate, falling gradually until by approximately 1:40 p.m. the blood pressure reading was 50/40. No vaginal bleeding was observed, and the patient's stomach was not hardened nor distended, which would indicate severe internal bleeding. By 1:00 p.m. the patient was described as "clammy". At approximately 12:00 noon the Respondent ordered blood from a local blood bank. He requested that the blood be ordered "STAT". This is an acronym which would indicate that the blood was needed on an emergency basis. Despite the Respondent's instruction, the nurse who filled out the order form ordered the blood on an "ASAP" basis. This designation would indicate that the blood was needed "as soon as possible", but not on a high priority basis. An employee of King Memorial was sent to the blood bank (the John Elliott Blood Bank). The blood bank is located approximately 30 minutes away from King Memorial by automobile. The employee drove to the blood bank, and submitted the order form. He waited there, and approximately 30 minutes later was told that he had the wrong papers, and insufficient samples. He returned to King Memorial, and received a corrected order form, which still reflected that the blood was needed on an "ASAP" basis. He returned to the John Elliott Blood Bank. He then waited 30 to 45 minutes more before the blood was delivered to him, and he returned with it to King Memorial. The blood did not ultimately arrive at King Memorial until approximately 3:00 p.m. when it was immediately administered to the patient. The Respondent had earlier administered a plasma substitute known as Dextran. The Respondent left King Memorial at approximately 1:40 p.m. to attend to patients at a different facility. He left the patient under the care of another physician. By 3:00 p.m. the patient's condition was deteriorating. Her stomach was beginning to distend. The Respondent was contacted, and he gave instructions to immediately arrange a transfer of the patient to Osteopathic General Hospital in Miami Beach. Osteopathic General Hospital is located approximately 8 minutes by automobile away from King Memorial. The Respondent notified physicians at Osteopathic General of Mrs. Vangates' condition, and personnel at Osteopathic General prepared for emergency surgery. At least three phone calls were made to the ambulance service following 3:00 p.m. Despite these efforts, and the fact that the two hospitals were located in such close proximity, the ambulance did not arrive at King Memorial until 4:22 p.m. When Mrs. Vangates arrived at Osteopathic General, she was in hypovolemic shock. This is a condition characterized by loss of fluid within the vascular space. She had virtually no vital signs, and an irregular heart beat. She was suffering from uterine hemorrhage, and brain damage which resulted from the loss of blood. An abdominal incision was made, and considerable blood and blood clots were found. An artery on the right side of her abdomen was damaged, and there was a 6 cm x 7 cm tear in the uterus, and a rupture of the entire uterine wall. An emergency hysterectomy was performed. On March 17, 1976, Mrs. Vangates died. She had lost considerable blood following surgery on March 13, and the loss of blood caused damage to the patient's vital organs. She died as a result. When the patient's blood pressure dropped drastically following surgery, the Respondent concluded that since there were no additional indications of hemorrhage, the cause was loss of blood during surgery, and a reaction to the anesthesia that had been administered. It is for that reason that he took steps to administer Aramine, so as to cause a rapid rise in the blood pressure. The Respondent's conclusion as to the cause of the drop in blood pressure was at that time reasonable under the circumstances. Lacerations and ruptures of the uterus are not an uncommon occurrence during the performance of abortions. This is especially so when an abortion is performed in connection with a pregnancy in the second trimester. In view of the possibility that the drop in blood pressure could have been the result of a substantial loss of blood, and the fact that blood was not available at King Memorial, the Respondent should have immediately ordered blood at the first signs of the drastic reduction in the patient's blood pressure. Administering Aramine was at best a temporary solution. Administering a plasma substitute was also a temporary measure. The Respondent did not make any effort beyond superficial ones to determine whether the patient was bleeding. By waiting until 12:00 noon to order the blood, he subjected the patient to the risk that the blood could not be obtained efficiently. Due to the facts that the blood was not ordered until 12:00 noon, that the blood was not obtained efficiently, and that the ambulance was slow in arriving, the patient's vital organs were subjected to damage as a result of loss of blood, ultimately resulting in her death. While the Respondent is not fully responsible for the delays, he was in a position to have taken steps that would have obviated the disastrous effects of the delays. In Count II of the Petitioner's complaint against the Respondent it is alleged as follows: That you, PAUL S. GLASSMAN, beginning on the 21st day of June, 1975 and continuing through the 22nd day of April, 1976, did unlaw- fully and feloniously agree, conspire, combine or confederate with ESTEBAN BOVEDA; MERCEDES BOVEDA; ESTEBAN BOVEDA, JR; MARIVA BOVEDA; OSWALDO MAERO and with others, to commit a felony to-wit: Grand Larceny and in further- ance of the unlawful scheme or conspiracy, you did meet with the above mentioned indi- viduals on various occasions to discuss and plan details as to the time, place and method of the commission of acts leading to the said larceny of monies from insurance companies by way of false and fraudulent claims to be made upon them as a result of contrived and false injuries, in violation of Section 777.04(3) and Section 833.04, Florida Statutes. In addition, on the following dates and times you did unlawfully and feloniously steal from the possession and lawful custody of the following named companies goods and lawful money in excess of One Hundred Dollars ($100.00) with the intent to permanently deprive or defraud the true owner of its property in vio- lation of Section 812.021(1)(a), (2)(a) Florida Statutes: November 3, 1975 Allstate Insurance Company March 3, 1976 Omaha Indemnity Company December 24, 1975 The Unity Mutual Life Insurance Company January 15, 1976 The Prudential Insurance Company of America The above is in violation of Section 459.14(2) (h), (k), (m) and (n) , Florida Statutes. At the hearing the Petitioner, through counsel, dropped the allegations of conspiracy, and stipulated that in the event the Respondent's conviction on the remaining charges were overturned on appeal, those charges would also be dismissed. To establish the allegations contained in Count II, the Petitioner presented a transcription of the testimony of Esteban Boveda, Mercedes Boveda, Esteban Boveda, Jr., and Maria Boveda. This testimony was originally presented at a criminal trial involving the same facts. The testimony of the Bovedas has been carefully examined, and it is concluded that their testimony is not worthy of belief. Esteban Boveda testified that he arranged with Oswaldo Maero to stage an automobile accident, and to stage fake injuries on the part of members of his family. Boveda testified that Maero made all of the arrangements, and gave all the instructions. Ultimately each of the Bovedas was examined by the Respondent, Dr. Glassman, who had them hospitalized. Esteban Boveda's testimony is not credible. In the first place, he was an admitted conspirator in a scheme to defraud numerous insurance companies, and he was willing to involve his wife, his 13 year old son, and his 10 year old daughter in the scheme, instructing each of them to lie about the accident. Furthermore, he plead guilty to criminal charges similar to those lodged against the Respondent, in exchange for an agreement that he would be placed on probation rather than in prison. It is clear that these events occurred at a time when Boveda had very little understanding of the English language, and none of his testimony with respect to anything Dr. Glassman said or did is worthy of belief. Mercedes Boveda, Esteban's wife, gave conflicting statements to the State's Attorney, during her depositions prior to the criminal trial, and at the criminal trial. Her willingness to lie on her husband's behalf was amply demonstrated. She, like her husband, had very little understanding of the English language, and her testimony is not creditable. The testimony of the two Boveda children is likewise not worthy of belief. They each testified that they would lie on their father's behalf if they were instructed to do so. It is evident that they were instructed to do so during the course of the accident, and that they would be willing to lie in court if so instructed by their father. The children had been in the United States for only one year at the time of these events, and had minimal understanding of the English language. All of the testimony that exists with respect to anything the Respondent said to the Bovedas about their injuries came from the two Boveda children. Their testimony was too clear and unambiguous in this respect, while being totally ambiguous and unclear in all other respects, to be worthy of belief. The Respondent testified on his own behalf with respect to the allegations of Count II. He testified that he diagnosed the Bovedas' ailments based on the history, and that his diagnosis was confirmed by other physicians. He testified that he was not part of any conspiracy to defraud insurance companies, and that he received only a single payment for the treatment that he administered the Bovedas. The Respondent's testimony is creditable, and has been accepted.
The Issue The issue is whether Respondent's license as a medical doctor should be disciplined for the reasons given in the Administrative Complaint filed on October 25, 2000.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background At all times material hereto, Respondent, David Lowell Williams (Respondent or Dr. Williams), was a licensed medical doctor having been issued license number ME 0035686 by Petitioner, Department of Health, Board of Medicine (Board). The Board is charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent is board-certified in cardiovascular disease and internal medicine and has practiced his specialty in Ormond Beach, Florida, since 1983. In 1990, Respondent accepted a position as a cardiologist with Florida Health Care Plan, Inc. Except for the charges raised in this proceeding, there is no evidence that Respondent has ever been involved in a prior disciplinary action. Based on a complaint filed with the Board by an attorney representing the family of a former patient, S.T., on October 25, 2000, the Department of Health, acting on behalf of the Board, filed an Administrative Complaint against Respondent generally alleging that in April 1995 he had failed to practice medicine with the level of skill and care required of a reasonably prudent physician, and that he failed to keep written medical records justifying the course of treatment of S.T. Respondent has denied the charges and contends that he practiced medicine within the standard of care and that the documentation related to the patient justified the course of treatment. In determining whether a deviation from the appropriate standard has occurred, the undersigned has considered the conflicting testimony presented by the witnesses and has accepted the more credible evidence, as reflected in the findings below. In doing so, the undersigned has discounted Petitioner's contention that Respondent's expert, Dr. Henderson, is a close friend of Respondent and therefore his testimony is clearly biased. Although the two once practiced together for a few years in the 1980's, Dr. Henderson acknowledged that they "don't get along very well right now." The treatment of the patient Over a period of years, S.T. was treated by several doctors, including Respondent, who participated in the Florida Health Care Plan, Inc. network. The medical records for that treatment have been received in evidence as Joint Exhibit No. Because they are not in chronological order, contain matters relating to treatment by physicians other than Respondent, and include some partially illigible pages, the records are somewhat difficult for the reader to navigate. They do show, however, that S.T. occasionally cancelled appointments, would not always accept his doctor's advice, sometimes refused to take prescribed medications, and was perhaps not totally candid at all times with the treating physician regarding his symptoms. The records reflect that Respondent first began treating S.T. on March 29, 1989, on referral from his primary care doctor, Dr. Moussly, due to complaints of "burning in chest with exercise." S.T., then a sixty-year-old male, underwent a stress test on the treadmill which was terminated after three and one-half minutes due to fatigue and shortness of breath. The test revealed "significant ST segment depression" and was consistent with ischemia (inadequate blood flow to the heart). Respondent prescribed Lopressor (a beta- blocking agent used in the treatment of hypertension and angina) and a Nitro-patch (transdermal nitroglycerin delivery system). Dr. Williams also recommended that the patient have a cardiac catherization. Even though the records show that the patient was "reluctant to do this at this point in time," they indicate that a coronary angiogram was performed by Respondent on April 26, 1989, and that "a high-grade stenosis of approximately 90 [percent] . . . with deeply ulcerated plaque" was exhibited in the left anterior descending artery. S.T. was again referred by Dr. Moussly to Respondent on March 7, 1990, "on an urgent basis." However, S.T. cancelled his appointment and accepted another appointment on April 4, 1990. Despite the urgency of the referral, S.T. reported to Dr. Williams that he was doing well with no symptoms since his last visit one year earlier. His records reflect that his blood pressure was 136/86, his weight 258, his pulse was 60 and regular, his lungs were clear, and a cardiovascular examination was unremarkable. Dr. Williams concluded that S.T. was stable at that time with minimal chest discomfort, and he recommended that S.T. undergo a routine treadmill exercise test to further evaluate his coronary heart disease. A stress test was performed on May 11, 1990, but it was terminated after three minutes due to shortness of breath. Another stress test was conducted on July 5, 1990, the results of which were "significant for ischemia." Although a cardiac catherization was recommended, "[t]he patient again refuses at this point in time." On May 1, 1991, S.T. was again seen by Respondent (after cancelling an earlier appointment) at which time he indicated he was feeling well and was essentially asymptomatic. He specifically denied having any shortness of breath, light-headedness, dizziness, or chest pain, and he reported that he had skipped taking his prescribed Cardizem on numerous occasions without undergoing any significant change in his symptoms. On that date, his blood pressure was 150/90, his weight 259, his lungs were clear, and the cardiovascular examination revealed no murmur. Dr. Williams concluded that the patient "seems to be stable at this point in time," and allowed S.T. to discontinue Cardizem as a therapeutic trial, and if he had no further symptoms, he would continue on Lopressor only. Otherwise, he would need to start up on that medication again. Finally, Dr. Williams offered S.T. the opportunity to participate in a beta blocker angina trial for which he would be evaluated the following week. The patient apparently declined this offer. The patient did not return to Respondent's office until December 21, 1994, or more than three years later, after he was given a "[r]outine referral for a stress test" by Dr. Moussly. S.T. had seen Dr. Moussly on a "routine followup" on December 1, 1994, at which time he denied having chest pain or shortness of breath. On his visit with Respondent, S.T. underwent another treadmill test that was terminated after two minutes due to the development of ST- segment depression. S.T. also experienced tightness in his chest. The treadmill tests were positive for ischemia "at low exercise tolerance." Based on the above results, S.T. agreed to undergo cardiac catherization. On December 28, 1994, Respondent performed the cardiac catherization on S.T., which revealed that the main coronary artery was very short, but was essentially normal. The left anterior descending artery (one of the three main arteries to the heart) exhibited a proximal 90 percent stenosis (stricture of a canal or narrowing of a cardiac valve). A second 75 percent stenosis was present in the distal portion of the artery. No other significant lesions were noted. The left circumflex artery was a large and dominant system. A stenosis in the distal portion of the parent circumflex of approximately 30 percent was present with no other significant lesions noted. The right coronary artery was a nondominant artery with no significant lesions noted. Based upon the results of the cardiac catherization, Dr. Williams concluded that P.T. demonstrated mild coronary artery disease in the left circumflex artery and "rather severe disease" in the left anterior descending artery. Respondent advised S.T. that he was a candidate for angioplasty (reconstitution or recanalization of a blood vessel) of the left anterior descending artery. On January 4, 1995, Respondent performed the angioplasty of S.T.'s left anterior descending artery, which contained two lesions. The proximal lesion was reduced from approximately 95 percent stenosis to around 10 percent, and the distal lesion was likewise reduced from approximately 75 percent stenosis to around 10 percent. On February 8, 1995, S.T. made a follow-up visit to Respondent's office. According to the patient notes, S.T.'s vital signs were normal, and he stated that he was "doing very well." Respondent's plan of treatment was to have him follow- up on an as-needed basis. In addition, Respondent discussed the "signs and symptoms of recurrence of chest discomfort" and the importance of stopping smoking as well as having good dietary practice and daily exercise. On March 7, 1995, Dr. Moussly again referred S.T. to Dr. Williams for a stress test due to the patient's "having very non[-]specific chest discomfort; non[-]exertional, non[-] radiating [pain that was] apparently . . . different than the pain he had prior to his angioplasty." Dr. Moussly also noted in his records that even though the patient had elevated cholesterol, he refused to take Pravachol, which had been prescribed by Dr. Moussly on December 1, 1994. Pursuant to the referral, on March 15, 1995, S.T. made a follow-up visit to Respondent complaining of "chest discomfort." He underwent another treadmill test which was terminated after three minutes due to chest discomfort and ST- segment depression. The test was positive for ischemia, which meant that restenosis of an artery had likely occurred. Respondent recommended repeat cardiac catheterization and angioplasty. Given S.T.'s age, progression of disease, and risk factors, which included "virtually every one known to man," restenosis was not particularly surprising since Respondent's expert established that "the restenosis rate for this [type of] patient was probably in excess of 50 percent." On March 17, 1995, Respondent performed a second angioplasty of S.T.'s left anterior descending artery and reduced the stenosis from 75 percent to 10 percent in both the proximal and distal lesions. There were no complications from this procedure, which S.T. tolerated well. On April 3, 1995, S.T. visited Respondent's office for a follow-up at which time he complained of chest discomfort. At that time, S.T. was "very vague about his discomfort" in terms of how often it occurred, how long it lasted, whether there were accompanying symptoms present, and whether the Nitroglycerin provided relief. S.T. did acknowledge, however, that the discomfort was "very infrequent." The records for that visit read as follows: Mr. T. since his last visit is having some chest discomfort, although, it has been better. He has taken some sublingual Nitroglycerin on a number of occasions, but is unable to recall exactly how often. His episodes are not exertionally related, different in type and severity than prior to his angioplasty. I feel he may be having coronary spasm, although, I cannot totally rule out restenosis. In any event, his symptoms are relatively mild. I have asked him to continue as we're doing. He wil [sic] return in two more weeks for follow-up examination. I have asked him to call should he get worse and he has, otherwise, been asked to keep a diary so that we can more objectively quantify his Nitroglycerin usage. Although S.T.'s vital signs are not recorded in the above note, Dr. Williams performed a physical examination of the patient that day, and he recorded the vital signs on a separate office record entitled "Vital Sign Sheet." He also maintained a separate patient medication chart, which reflected the various medications taken by all his patients; however, due to its age, that chart has been purged in the normal course of business. A stress test was not ordered by Respondent since he considered the patient's chest discomfort to be "very mild," and the patient described the pain as "completely different" than his previous angina. Also, the pain was not exertionally related, and restenosis was unlikely "at this early date following an angioplasty." Dr. Williams concluded that more than likely the pain was a coronary spasm (a muscular contraction of the wall of the artery), which typically occurs up to 30 to 60 days after the procedure, and he would wait "to see if [the symptoms are going] to go away . . . [w]hich they frequently do after an angioplasty." Finally, Respondent noted that the cardinal indicators of ischemic heart disease (a blockage) were not present - - exertional pain, relief from Nitroglycerin, and a similarity with pain experienced before the angioplasty was performed. He accordingly advised S.T. to continue his present course of treatment and to follow-up in two weeks, or if his condition worsened, to return sooner or go to an emergency room. On Friday, April 7, 1995, S.T. went to the Halifax Hospital Emergency Room in Daytona Beach, Florida, complaining of chest pressure, accompanied by an episode of dizziness, weakness, diaphoresis, and nausea. He also advised that he had been taking several Nitroglycerines on a regular basis. Respondent was not present at the facility, and was not the on-call cardiologist on this date. S.T. was seen by Dr. David E. Stibbins, who observed that S.T. was bradycardic and had low blood pressure. Like the information given to Dr. Williams on April 3, here the patient gave vague information regarding his chest discomfort. The records suggest that Dr. Stibbins opined that the patient's discomfort was not cardiac related and was probably due to anxiety. A cardiac consultation was requested, but not conducted, and S.T. was kept in the hospital overnight for observation. Around 1:15 a.m., S.T. reported a few "twinges" in his chest to the nurse, but he told her the pain was not serious enough to wake up his doctor. After denying that he had experienced any chest pain other than the few twinges described above, on the afternoon of April 8, 1995, S.T. was discharged from the hospital in stable condition (without ever being seen by a cardiologist) and advised to follow-up with Respondent in two days (the following Monday). On Sunday, April 9, 1995, the patient suffered a cardiac event and expired. The cause of death on his certificate of death is probable sudden death as a result of coronary artery disease, but neither expert in this case could give a precise reason for S.T.'s demise. The standard of care In the aftermath of an angioplasty, a variety of things can occur causing chest discomfort in the patient. While the beneficial effects of an angioplasty "can last . . . [up] to 20 years," three to five percent of patients experience an acute closure within a matter of minutes or hours, which is the sudden and complete obstruction of the artery. Because of this risk, after a procedure is performed, patients are kept in the hospital at least over night for observation. An acute closure often occurs in patients with a 70 to 80 percent narrowing of the artery. During the first few weeks after a procedure, acute thrombosis to the vessel at the site of the injury sometimes occurs, but a patient with that condition would experience "intense discomfort that's exactly the same as the patient's pre-intervention discomfort." Without such symptoms, that diagnosis would be "down [on] the list of considerations" by the treating physician. Between six and eight weeks and four months after the procedure, up to a third of balloon angioplasty patients experience a subacute closure (or restenosis) of the artery. Typically, these patients return to the physician's office with clinical symptoms of angina chest pain (similar to that experienced before the procedure) and require a repeat procedure. If restenosis has occurred, the patient is at risk for additional cardiac complications, such as myocardial infarction (heart attack). In some cases, within 30 to 60 days after a procedure, a patient will experience a "different type of sensation" in the chest due to the mechanical stretching of the vessel wall during the procedure. Other patients experience an artery spasm (cramping of the vessel wall), which occurs when the muscle cells go into spasm and constrict the artery. In both of these situations, the discomfort is dissimilar to that experienced before the procedure. Given the foregoing, if a patient presents himself to the doctor within a matter of weeks after an angioplasty with vague, non-ischemic related chest discomfort, it is not a deviation from the standard of care for the physician to choose a course of treatment consisting of "medical management" of the patient, that is, the close monitoring of the patient in the following days and weeks, and treating the patient with beta blockers, nitrates, and aspirin to ameliorate his symptoms. Conversely, if a patient presents himself to the physician with chest discomfort which is ischemic in nature, the ordering of further tests, including an exercise EKG, would be appropriate, with possible referral to a hospital for another cardiac catherization. Other considerations in determining the appropriate course of treatment of a patient include the cardiologist's familiarity with the patient's prior symptoms and history and the symptoms presented at the current time. In addition, the physician must rely upon his experience, knowledge, and education in the field. Taking into account all of these circumstances and considerations, the more convincing evidence establishes that Respondent did not deviate from the standard of care. c. The adequacy of the patient's records The Board has also alleged that Respondent failed to keep adequate medical records on the April 3, 1995, office visit in that he failed to document a physical examination or the results of any ancillary tests, and that the records as a whole fail to justify the course of treatment of the patient. The criticisms of Dr. Williams are based upon the testimony of the Board's expert, Dr. Dormois, who presented deposition testimony in this matter. In his deposition, however, Dr. Dormois withdrew his earlier criticisms of the records, and he indicated that the records provided by Dr. Williams "are generally adequate." He also concluded that this case "is not an issue of a medical record deficiency," but rather is "a deficiency of [a] failure to make clinical decisions." When these admissions are coupled with the testimony of Dr. Henderson, who concluded that the records were adequate, it is found that the Respondent kept written medical records justifying the course of treatment of the patient.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing, with prejudice, the Administrative Complaint. DONE AND ENTERED this 30th day of August, 2001, in Tallahassee, Leon County, Florida. ___________________________________ DONALD R. ALEXANDER 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 30th day of August, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration Post Office Box 4229 Tallahassee, Florida 32317-4229 Michael R. D'Lugo, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 390 North Orange Avenue Orlando, Florida 32802-1646 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues in this case are whether Respondent violated section 458.331(1)(t), Florida Statutes (2008),1/ and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. Dr. Puig was at all times material to the allegations in the Administrative Complaint a licensed physician in the State of Florida, having been issued license No. 82847. Dr. Puig holds a certificate from the American Board of Anesthesiology. In the early morning of January 2, 2009, T.M. presented to the Central Florida Surgery Center in Lakeland, Florida, for outpatient surgery to be performed by Shreekant Tripathi, M.D. The specific procedures to be performed were bilateral lower eyelid blepharoplasty, mini-face lift, and suspension of the mid-face area with the Endotine Midface implant device. She was accompanied by her husband, R.R. T.M. has been licensed as a physician in Florida for 28 years and has worked as the head of the Tampa General Hospital Adult Emergency Department and as that hospital's chief of staff. T.M. has a prior history of a deep vein thrombosis (DVT), which was treated medically. She experienced a DVT in her leg sitting in an airplane for an extended period of time while traveling from Florida to the Midwest. DVT is a medical condition that occurs when a thrombus (blood clot) forms in one of the large veins, leading to either partial or complete blockage of the vein. After completing the financial paperwork and other forms at the front desk of Central Florida Surgery Center, T.M. was taken to the pre-operative holding area at approximately 7:00 a.m. Once in the pre-operative holding area, the nurse went over the contents of T.M.'s procedures and reviewed T.M.'s medical history and medications taken. The nurse administered medications other than sedation and took T.M.'s vital signs, including her blood pressure. In order to take T.M.'s blood pressure, the nurse in the pre-operative holding area placed a blood pressure cuff on T.M.'s right upper arm. The blood pressure cuff would not have given a reading if it was placed too tightly, and T.M. would have complained of pain. At the time that the blood pressure cuff was placed, T.M. was awake and alert and did not express any discomfort. The nurse was able to get a reading from the blood pressure cuff. While T.M. was in the pre-operative holding area and after the vital signs were taken, T.M.'s temperature was 97.4 degrees. T.M. met with Dr. Tripathi, who went over her surgery with her. Dr. Tripathi marked the areas for her facial cosmetic procedures. Dr. Puig served on the surgical team as anesthesiologist. He conducted a pre-anesthesia evaluation of T.M. Dr. Puig examined T.M. and reviewed the medications that she was taking. He also reviewed T.M.'s medical history, including her history of DVT. As part of his plan for anesthesia, Dr. Puig included the use of sequential compression devices on T.M.'s lower extremities. While in the pre-operative holding area, T.M. was given Versed as a pre-medication for the surgery. T.M. was taken to the operating room, accompanied by Dr. Puig, who remained with T.M. until she was handed to the post-anesthesia care unit (PACU) nurse. T.M. entered the operating room at 8:19 a.m. The blood pressure cuff that was placed by the pre-operative nurse was left in place on the upper right arm. The blood pressure cuff was disconnected from the monitoring device in the pre-operative holding area and accompanied T.M. into the operating room, where it was connected to another monitoring device. After T.M. was taken to the operating room, she moved onto the operating table on her own with some assistance. Monitoring equipment was then connected to T.M. The monitoring equipment included a pulse oximeter on the left hand, sequential compression devices on the lower extremities, and the blood pressure monitoring device. Dr. Puig did not use any device to monitor T.M.'s temperature during the surgery. An IV had been placed in the pre-operative area on T.M.'s left wrist and was running in the operating room. T.M. was positioned flat on her back on the operating table with her shoulders on the operating table using a mattress, a pillow, foam pads, and sheets. On the table, under T.M., was a two-to-three-inch thick mattress. On top of the mattress, under T.M., was a bottom sheet that ran longitudinally the length of the table. On top of the bottom sheet, perpendicular with, or at a 90-degree angle to the table, was a folded sheet from 18-to-30 inches wide. This crossways sheet is called a draw sheet and was under T.M. with the top edge at the armpit and the lower end in line with the waist or buttocks. The draw sheet was pulled up between T.M.'s arm and torso for later tucking. A foam pad, egg-crate device was placed on the right arm between the arm and the table and T.M. The device is not large enough to completely cover the arm. The bottom sheet was tucked around the arm between the egg-crate device and T.M.'s torso. The draw sheet was then tucked around the outside of the arm and under the mattress with a portion left protruding, which could be pulled on later to begin the process of removing the sheets. The purpose of the sheets was to keep T.M.'s arm from falling off the table during surgery. The sheets were supposed to be snug, but not so tight that one could not insert two fingers between the sheets and T.M.'s arm. In addition to the sheets that covered T.M., a Bair Hugger was used. A Bair Hugger is a warming device that uses forced warm air to keep a patient warm during surgery. The blood pressure cuff was under a portion of the egg-crate device, the bottom sheet, the draw sheet, and the Bair Hugger. The top edge of the blood pressure cuff was just under the armpit and the bottom edge was approximately three-to-four inches above the elbow joint. The blood pressure cuff had an inflatable rubber bladder and normally would have an attached inlet tube about six-to-eight inches long that would extend down T.M.'s arm toward her wrist. In order to eliminate sources of infection, a sterile field was created by using sterile towels and sterile drapes. The sterile drape covered T.M. after the other sheets and blankets were in place. The sterile towels were placed around T.M.'s head. At 8:41 a.m., the surgery began. Prior to the commencement of surgery and while in the operating room, Dr. Puig monitored T.M.'s blood pressure using the monitoring device in the operating room and the blood pressure cuff that was placed on T.M.'s right arm. Dr. Puig had blood pressure readings until 8:58 a.m., when Dr. Puig was unable to get blood pressure readings. Dr. Puig asked Dr. Tripathi to step aside and allow him to check the blood pressure cuff. Dr. Puig was on the right side of T.M. and moved to the left side of T.M. He asked the circulating nurse to hold the sterile drape so that he could go under the drape to check the blood pressure cuff. Dr. Puig went under the drape and felt the blood pressure cuff. The blood pressure cuff was deflated. He disconnected the tube from the blood pressure cuff and called for a new blood pressure cuff. He placed the new blood pressure cuff on T.M.'s left arm and connected the new blood pressure cuff to the blood pressure monitoring device. Dr. Puig was able to get accurate blood pressure readings from the new blood pressure cuff and the monitoring device that had been attached to the blood pressure cuff on T.M.'s right arm. Dr. Puig left the deflated blood pressure cuff on T.M.'s right arm during the surgery. After a blood pressure cuff was placed on T.M.'s left arm, Dr. Tripathi continued with the surgery. The surgery ended at 1:48 p.m., at which time the circulating nurse began to remove the sterile drape and sheets from T.M. When the nurse removed the deflated blood pressure cuff on T.M.'s right arm, she noticed that the arm below the blood pressure cuff was mottled, blue, red, dark blue and dark red. There were blisters on T.M.'s right arm where the blood pressure cuff had been. T.M.'s right arm was swollen. The condition of T.M.'s right arm was brought to the attention of Dr. Puig. Dr. Puig examined and evaluated T.M.'s condition. At 2:00 p.m., T.M. was transferred to the PACU. T.M. was alert. Her temperature was 98 degrees. Her husband, R.R., was at bedside when T.M. was taken to PACU and stayed at her bedside until T.M. was discharged. T.M. was experiencing extreme pain in her right arm and felt a tender hard spot on her right bicep. The post- operative nurse noted the condition of T.M's right arm as red and swollen from the biceps to the tips of T.M.'s fingers with blisters on the upper part of the extremity. Dr. Puig noted that T.M. had decreased sensation in her right finger tips and some decrease in motor activity and that T.M's radial and ulnar pulses were intact. He ordered that the right arm be elevated with the use of pillows. At 2:15 p.m., Dr. Puig was at T.M.'s bedside, monitoring T.M.'s condition. Dr. Tripathi was aware of T.M.'s condition and also appeared at her bedside to monitor her condition. Dr. Puig consulted with Dr. Tripathi concerning T.M.'s condition. At 2:30 p.m., T.M. was still being monitored by the PACU nurse. T.M. was moving her arm, fingers, and wrist. At 2:55 p.m., T.M. told the nurse that she was unable to feel her pulse. Two nurses took T.M.'s pulse and verified that T.M. did have a pulse. Dr. Puig and Dr. Tripathi had gone back to the operating room for a procedure on another patient. At 2:55 p.m., a nurse notified Dr. Puig of T.M.'s complaint of feeling no pulse. At 3:08 p.m., T.M. complained of a decrease in sensation from her elbow to her fingers. T.M. suggested to the PACU nurse that measurements should be taken of the circumference of her arms to determine how much swelling had occurred. At 3:10 p.m., the nurse marked the area on the arms to be measured and took measurements of the bicep and forearm in each arm. The right bicep measured 30 centimeters, and the right forearm measured 28 centimeters. The left bicep measured 29 centimeters, and the forearm measured centimeters. T.M. and her husband became concerned about the condition of T.M.'s right arm. The right arm was still elevated by pillows, and T.M. continued to exercise the arm. At 3:14 p.m., T.M. stated that she could feel her right radial pulse. T.M.'s right bicep remained red and swollen. T.M. denied the need for pain medication. At 3:20 p.m., T.M. continued to exercise the right arm, hand, wrist, and fingers. T.M. complained of pain in the right bicep and a knot in the right bicep. At 3:40 p.m., T.M. continued to complain of pain in the right bicep. T.M. was squeezing her right hand and moving her right arm. T.M. was experiencing a prickly sensation to her forearm and hand from the elbow down. The nurse determined that there was a right radial pulse. Dr. Puig was notified of T.M.'s condition. The nurse gave T.M. a bolus of 25 micrograms of Fentanyl; however, the pain medication did not give T.M. any relief. Dr. Puig had given an order for 25 micrograms of Fentanyl to be administered every five-to-15 minutes up to a maximum of 100 micrograms. Fentanyl is a short-acting pain medication. The opiate is more potent that morphine. The effects of Fentanyl will wear off about 20 to 30 minutes after administration. At 3:50 p.m., the nurse administered another bolus of micrograms of Fentanyl to T.M. At 3:54 p.m., T.M was fully flexing and extending her right arm and stated that the second dose of Fentanyl had given her some relief to the pain. At 4:00 p.m., the nurse measured the right arm again. The right bicep was 30 centimeters, and the right forearm was 26.5 centimeters. At 4:07 p.m., T.M. requested more pain medication, and the nurse administered another bolus of 25 micrograms of Fentanyl. T.M. received fair relief from the pain as a result of the pain medication. At 4:25 p.m., T.M. stated that she could feel sensation to her right hand, but was unable to distinguish between sharp and dull pain. She denied the need for further pain medication. At 4:41 p.m., T.M. continued to have pain in her right bicep. She was experiencing numbness and tingling in her right hand and forearm. From the right elbow to her hand, her arm was red, mottled, and petechiae. The right bicep was warm and swollen with thin blisters. The bicep was firm and painful. T.M. requested and was given another 25 micrograms of Fentanyl. At 4:50 p.m., the pain medication had produced only minimal relief from the pain. At 4:53 p.m., T.M. told the PACU nurse that her pain and swelling was not getting any better and that she wanted to be transferred to Tampa General Hospital after she saw Dr. Puig and Dr. Tripathi, who were still in surgery. Dr. Puig and Dr. Tripathi were notified in the operating room. The nurse continued to monitor T.M. T.M. thought that she may have compartment syndrome. Compartment syndrome is a condition that results from increased pressure in the compartment (the muscle surrounded by the fascia), which can lead to lack of perfusion, nerve damage, and eventually to the loss of function of the extremity. It is characterized by pain out of proportion to the nature of the observable injury that will not be alleviated by the administration of narcotic pain medication, swelling, pallor, paraesthesia, lack of pulse, and eventually lack of temperature control. Dr. Puig consulted with Dr. Tripathi throughout the time that T.M. was in PACU concerning T.M.'s right arm. Dr. Tripathi has had training in hand surgery, and, as a surgeon, is familiar with compartment syndrome. Compartment syndrome in the upper arm is a rare event. Neither Dr. Puig, nor Dr. Tripathi, felt that the swelling and pain in T.M.'s arm was due to compartment syndrome. Because of her history with DVT and the similarity of some of the conditions associated with both compartment syndrome and DVT, it was felt that T.M. could have DVT in her upper arm. At 5:00 p.m., Dr. Puig and Dr. Tripathi came to T.M.'s bedside. T.M. was able to flex and extend the right fingers, to perform abduction and adduction of the right fingers, and to extend and flex the right wrist. At 5:30 p.m., Dr. Puig was again at T.M.'s bedside. Ice was applied to the elevated bicep. The circumference of the right bicep was measured and recorded at 33 centimeters. T.M. requested that the PACU nurse call Dr. Kelly O'Keefe at Tampa General Hospital. T.M. spoke to Dr. O'Keefe and advised that she was coming to the emergency room at Tampa General Hospital. Dr. Tripathi and Dr. Puig were aware that T.M. was going to Tampa General Hospital. Dr. Tripathi suggested that an ultrasound be done. At 6:00 p.m., T.M. requested that she been given another dose of Fentanyl to help with the pain while she was traveling to Tampa General Hospital, which was about an hour away from the Central Florida Surgery Center. She was discharged to be transported to Tampa General Hospital by her husband via automobile. At the time of discharge, there was continued swelling and redness of T.M.'s right arm. She was experiencing pain in her right bicep. Her right arm from her elbow to fingers was eccymotic. T.M. presented at the Tampa General Hospital Emergency Department approximately an hour after her discharge from the Central Florida Surgery Center. When she arrived at Tampa General Hospital, her right arm was red and swollen from her elbow to her fingertips. Her motor/sensory function was intact with positive radial and ulnar pulse by Doppler. She was triaged as a semi-urgent patient, Acuity 4. Dr. Kelly O'Keefe examined T.M. and found the following: Extremity/Pain-injury to the RUE, pt underwent surgery today, possible issue with bp cuff right arm during surgery, pt with redness and swelling from elbow joint to finger tips, m/s intact, positive radial pulse and dopplarble [sic] ulnar. Had blepharoplasty and chin tuck done. Pain in left arm is 10/10. Arm is swollen. Forearm with petchia [sic] diffusely, NO SOB, no chest pain. No fever. NO other current complaints. Cuff on about an hour. Prior DVT, off Coumadin now, in leg. NO PE in past. Weakness of hand/wrist associated with pain. Primary symptom. Dr. O'Keefe's differential diagnosis was the following: Evaluate for DVT in upper extremity ?arterial occlusion secondary to cuff without ongoing evidence of arterial blockage, but with likely ischemic neuropathy. Will consult neurology. Doppler scans ordered. Dr. O'Keefe ordered, among other things, a Doppler scan, a complete blood count, a cretatine phosphokinase blood (CPK) study, elevation of the arm, and Fentanyl for pain. He requested consultations with a neurologist and a vascular surgeon. At 7:49 p.m., T.M. was given 100 micrograms of Fentanyl. An ultrasound was performed. After T.M. returned from having an ultrasound done, the nurse noted that T.M. was complaining of pain in her right arm as ten, on a scale of one to ten, with ten being the most painful. There was edema to the right bicep area with stripes of vertical ecchymosis around the entire bicep. The bicep was tender to palpitation and slightly hard to the touch. Petechiae and ecchymosis were noted from elbow to fingertips. The area from the elbow to the fingertips was also edematous, tender to palpitation. Radial and ulnar pulses were detected using a bedside Doppler. There was positive motor/sensory function in the right arm, but slightly weak. T.M.'s right arm was elevated and ice packs were applied. At 9:36 p.m., the neurologist was at bedside with T.M. At 9:42 p.m., Dr. O'Keefe noted that T.M.'s pain and swelling were worsening, which suggested the development of compartment syndrome. At 10:07 p.m., T.M. was given another 100 micrograms of Fentanyl. At 10:45 p.m., T.M. was complaining of pain in her right arm as a ten, on a scale of one to ten. T.M. stated that the Fentanyl was not lasting very long. Dr. O'Keefe was notified, and he ordered one milligram of Dilaudid. At 9:56 p.m., Dr. O'Keefe noted that the Doppler study indicated that there was "[n]o evidence of arterial thrombosis or high grade stenosis," thus, ruling out DVT. The vascular surgeon, Dr. Brad Johnson, saw T.M. at 11:23 p.m. Dr. Johnson was concerned about compartment syndrome. He performed a right upper arm fasciotomy. His discharge diagnosis was right upper-extremity compartment syndrome. As part of his board certification, Dr. Puig is required to comply with the American Society of Anesthesiologists guidelines for anesthesia care. The American Society of Anesthesiologists has developed Standards for Basic Anesthetic Monitoring. The preamble provides: These standards apply to all anesthesia care although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible anesthesiologist. They are intended to encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. They apply to all general anesthetics, regional anesthetics and monitored anesthesia care. This set of standards addresses only the issue of basic anesthetic monitoring, which is one component of anesthesia care. In certain rare or unusual circumstances, 1) some of these methods of monitoring may be clinically impractical, and 2) appropriate use of the described monitoring methods may fail to detect untoward clinical developments. Brief interruptions of continual monitoring may be unavoidable. These standards are not intended for application to the care of the obstetrical patient in labor or in the conduct of pain management. Standard II of the Standards for Basic Anesthetic Monitoring provides: During all anesthetics, the patient's oxygenation, ventilation, circulation and temperature shall be continually evaluated. * * * BODY TEMPERATURE OBJECTIVE To aid in the maintenance of appropriate body temperature during all anesthetics. METHODS Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated or suspected. Loss of large amounts of blood or exposure of body surface was not contemplated for T.M.'s cosmetic surgery. Since T.M. was an adult, was almost completely covered by sheets, and was under a Bair Hugger which supplied forced warm air, Dr. Puig did not feel that T.M. would experience clinically significant changes in body temperature. Dr. Puig controlled the amount of fluids used during the surgery and anticipated the blood loss based on the incisions that would be used by Dr. Tripathi. Dr. Sanchez-Salazar testified as an expert for the Department. Dr. Sanchez-Salazar is a board-certified anesthesiologist. He has been licensed to practice medicine in Florida since 1963. He has been working as a solo practitioner in a stand-alone outpatient surgical facility since 1993. Dr. Sanchez-Salazar testified at the final hearing that he interpreted the temperature-monitoring standards of the American Society of Anesthesiologists to mean that the body temperature of a patient had to be monitored at all times during surgery. He also testified at the final hearing that he does not monitor the patient's temperature during surgeries that last a short period of time. During his deposition taken on August 17, 2010, he testified that he did not monitor patients' temperatures on procedures that lasted an hour or less. He also opined that the monitoring standards of the American Society of Anesthesiologists required that temperatures be monitored when the surgery lasted more than an hour. It is clear that Dr. Sanchez-Salazar did not consider that the monitoring of temperatures should be determined based on whether a clinically significant change in temperature would be intended, anticipated, or suspected. Dr. Sanchez-Salazar's testimony is not credible. Dr. Nikolaus Gravenstein testified as an expert for Dr. Puig. Dr. Gravenstein has been licensed to practice in Florida since 1983. He became board-certified in anesthesiology in 1984 and has continued to voluntarily recertify. He is a professor of anesthesiology at the University of Florida. Dr. Raphael Miguel testified by deposition as an expert for Dr. Puig. Dr. Miguel has been licensed to practice in Florida since 1984. He is board-certified in anesthesiology. Both Dr. Miguel and Dr. Gravenstein opined that based on the American Society of Anesthesiologists standards for monitoring that Dr. Puig was not required to monitor the temperature of T.M. during surgery because there was a low expectation that there would be a clinically significant change in T.M.'s temperature. The testimony of Drs. Miguel and Gravenstein is credited. At the final hearing, Dr. Sanchez-Salazar testified that it was a violation of the standard of care to leave a blood pressure cuff on a patient who is having surgery when the blood pressure cuff is not working and that Dr. Puig violated the standard of care when he left the blood pressure cuff on T.M.'s right arm. When questioned by counsel for Dr. Puig at his deposition taken on August 17, 2010, Dr. Sanchez-Salazar testified that it was not a violation of the standard of care to leave the blood pressure cuff on T.M. However, when Dr. Salazar was questioned by the Department's counsel in the same deposition, he opined that it was a violation of the standard of care to leave the blood pressure cuff on T.M. Dr. Sanchez- Salazar's testimony concerning leaving the blood pressure cuff on T.M. lacks credibility. It is Dr. Gravenstein's opinion that Dr. Puig did not violate the standard of care when he disconnected from the monitoring device, but did not remove the blood pressure cuff from T.M.'s right arm. It is his opinion that most people in the same situation would not remove the blood pressure cuff, because it would be difficult to remove the blood pressure cuff without violating the sterile field. A violation of the sterile field would risk infection of the surgical site. In balancing the need to remove a blood pressure cuff that is not inflated against the need to keep a sterile field, the anesthesiologist should leave the deflated blood pressure in place. Dr. Gravenstein's testimony is credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Puig did not violate section 458.331(1)(t) and dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of March, 2011, 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 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of March, 2011.
