The Issue At issue in this proceeding is whether Cortina Fountain, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Ann Williams' prenatal course and the birth of Cortina Fountain Due to a paucity of proof, little is known of Ann Williams' prenatal care except that at or about 6:10 a.m., August 3, 1992, she was seen at Waterman Medical Center, Eustis, Florida, for a prenatal progress check. 1/ At the time, Ms. Williams complained of contractions at 15 minute intervals, dilation was noted to be "1-2, thick, high;" and fetal heart tone was noted to be in the 130 beat per minute range. The midwife was called, and upon receipt of her orders Ms. Williams was discharged home with instructions "to call Tavares Clinic today to be seen." At 12:15 p.m. that day, Ms. Williams, while at home, precipitously delivered her child, Cortina Fountain (Cortina), in the toilet. Emergency medical services were called, and Ms. Williams and Cortina were taken by ambulance to Waterman Medical Center, where they were admitted at 1:10 p.m. that day. 2/ Upon admission to the hospital, physical examination revealed Cortina to be a viable female infant, with normal activity and no overt abnormalities. No evidence of trauma, cyanosis or poor oxygenation function, or cardiac function was observed, and Cortina exhibited all normal neurologic reflexes, such as Moro, suck, and grasp. Moreover, no abnormality of the anterior fontanel of the infant was noted. Cortina remained in the hospital until August 5, 1992, when she was discharged to the care of her mother. During her two day residence in the hospital, Cortina did not evidence any abnormalities. Rather, she fed well and gained weight, did not demonstrate any bruising or trauma, and did not demonstrate any neurologic changes or other abnormalities. Cortina's subsequent development and readmission to the hospital Cortina was readmitted to Waterman Medical Center, through the emergency room, at or about 6:35 p.m., September 11, 1992. At the time, history reflected that her development was apparently uneventful until one or two days prior to admission. During that time, Cortina stopped taking her formula, became progressively lethargic, vomited, and experienced episodes of diarrhea. For the twenty four hour period prior to her admission, Cortina was noted to be febrile. Upon admission, Cortina was noted to be extremely emaciated, having a weight of 4 pounds 3 ounces compared to her birth weight of 5 pounds 12 ounces. She was also noted to be listless, markedly dehydrated, and with bulging anterior fontanelle and a temperature of 104 degrees Farenheit. Testing revealed electrolyte imbalance and metabolic acidosis. Such symptomology was consistent with central nervous system infection, and Cortina was started on oxygen, intravenous fluids, including dextrose, and Rocephin. At or about 10:35 p.m., September 11, 1992, she was transferred by helicopter to the neonatal intensive care unit at Florida Hospital Medical Center (Florida Hospital) in Orlando, Florida. Cortina remained at Florida Hospital until October 2, 1992, when she was discharged to the care of her mother. Her course at Florida Hospital was adequately set forth in her discharge summary as follows: PHYSICAL EXAMINATION: Physical examination on arrival at Florida Hospital Medical Center, pediatric intensive care unit, revealed a marasmic, somewhat listless, black female who was markedly dehydrated. Temperature was 103 degrees Fahrenheit. Heart rate ranged between 170 and 190, and blood pressure was 83/53. She was intubated, and the anterior fontanelle was somewhat sunken at this time. IMPRESSION ON ADMISSION: FEVER WITH A POSSIBILITY OF SEPSIS. BORDERLINE HYPOGLYCEMIA. SEVERE DEHYDRATION. MARASMUS. RULE OUT A METABOLIC DISORDER OR A VIRAL ENCEPHALOPATHY. HOSPITAL COURSE: Upon admission, a central line was placed, and patient was placed on assisted ventilation. The fontanelle was initially sunken but after adequate hydration was noted to be bulging during the night. A computerized axial tomo- graphy scan of the brain was obtained on an emergency basis, and this revealed diffuse brain swelling. The patient was started on hyperventilation with the addition of intravenous mannitol. Additional laboratory data that was obtained included a liver profile which showed her albumin to be 2.0, SGPT was 52, SGOT 39, GGT 350, serum ammonia 161 which is increased, serum lactase was 6.5 which is also increased. Reticulocyte count was 3.7 [percent] and hemoglobin and hematocrit were decreased to 5.8 and 18.0 respectively. Endotracheal tube aspirate that was sent for respiratory syncytial virus came back negative. Hospital course will be further discussed on the problem list. PROBLEM [NO.] 1: ENCEPHALOPATHY WITH BRAIN SWELLING AND SEIZURE DISORDER. After the initial presentation and the finding of cerebral swelling, the patient was started on hyperventilation with intravenous mannitol. She was noted to have fisting of the hands and occasional jerky movements that were associated with bradycardia, and an electroencephalogram that was done revealed seizure activity. Hence, she was started on intravenous phenobarbital which was slowly increased over 24 hours until clinical control of the seizures was obtained. Subsequent electroencephalograms that were done on September 14, 1992, still showed frequent multifocal epileptiform discharges, although there was no clinical evidence of seizure disorder. In light of this, her dose of phenobarbital was increased after an initial minibolus. A pheno- barbital level in the upper 20s to lower 30s was maintained with a dose of phenobarbital 6 mg b.i.d. Repeat electroencephalograms done on September 17, 1992, and September 25, 1992, were abnormal, as manifested by diffuse sharp and slow wave discharges in the waking state which got accentuated by sleep. . . . on September 12, 1992, the patient was also started on intravenous acyclovir because of the possibility of herpes encephalitis. A lumbar puncture was not repeated for further cerebrospinal fluid studies because of the presence of the cerebral swelling, but an attempt to obtain cerebrospinal fluid via a subdural tap was futile. The patient was slowly weaned off the ventilator and finally extubated on September 17, 1992. The mannitol was weaned off over the next four days and discontinued on September 20, 1992. The Rocephin was continued for a total of 10 days and the acyclovir for a total of 14 days. At the time of discharge and for at least one week prior to discharge, she was able to track very well, was feeding well, and had essentially a normal neurologic examination. Auditory brain stem evoked response studies that were done revealed normal hearing in both ears. A computerized axial tomography scan of the brain that was done on September 22, 1992, showed diffuse, decreased density within the cerebral hemispheres bilaterally with preservation of the basal ganglia and thalamus. There was interval volume loss in the cerebral hemispheres which was felt to be consistent with resolution of the cerebral edema. PROBLEM [NO.] 2: DEHYDRATION AND ELECTROLYTE ANOMALIES. On the day of admission, the patient had a BUN of 38 with a creatinine of 1.2 and a glucose of 60. She was placed on D10 one-quarter normal saline and the dehydration was corrected slowly over 48 hours. Over the ensuing week, she developed anasarca, mostly due to hypoalbuminemic state, but this resolved at least one to two weeks prior to discharge. A Chem-21 that was done on September 29, 1992, showed a sodium of 137, potassium 5.2, chloride 106, CO2 20.6, glucose 96, creatinine 0.5, BUN 13. The rest of the Chem-21 profile was essentially with normal limits. Specifically, the albumin had risen to 3.5 on September 29, 1992. PROBLEM [NO.] 3: ANEMIA. At the time of her admission, the patient's hematrocrit was 22 [percent] but this dropped to 18 [percent] after she was rehydrated. She was transfused on two occasions, and after this she maintained a reasonable hematocrit until the time of discharge. A complete blood count that was done on September 29, 1992, showed a white blood cell count of 13,800, hemoglobin 14.0, hematocrit 40.8, platelet count 151,000. There were 41 segs, 1 band, 43 lymphs, 13 monos and 2 eosinophils. * * * PROBLEM [NO.] 4: HEPATOPATHY WITH HYPERLACTASEMIA AND HYPERAMMONEMIA. It was felt that the patient's hepatopathy and abnormal laboratory data related to the liver function was probably due to a viral or metabolic problem. Urine for amino acid screen was essen- tially negative, and urine for organic acid screen came back showing an abnormal peak with octeny- lsuccinic acid. It was felt by Dr. McReynolds that this is an emulsifier that is used in certain infant formulas, and repeat testing for this purpose has been scheduled on an outpatient basis. The metabolic studies that are pending at the time of discharge include blood amino acid profile and also serum isocarnitine profile. PROBLEM [NO.] 5: MALNUTRITION. Patient looked significant marasmic on the date of admission and had an admission weight of 4 lb. 3 oz. At the time of discharge, she was toler- ating full-strength Pregestimil and was gaining weight daily. Her discharge weight is 6 lb. 7 oz. (2.9 kg). Her head circumference was 35.5 cm at the time of discharge. PROBLEM [NO.] 6: INFECTIOUS DISEASE. In spite of the septic workup, there was no identifiable causative organism, although a viral etiology could not be totally ruled out. Blood for herpes simplex IgM titers was un- revealing. In spite of the negative studies, the patient was given the benefit of the doubt and treated with meningitic doses of Rocephin for 10 days and meningitic doses of acyclovir for 14 days. . . . Cortina's discharge diagnoses were "severe encephalopathy with cerebral edema and epilepticus," "ongoing seizure disorder," and "anemia with abnormal peripheral smear." The cause and severity of Cortina's neurologic injury Although the proof demonstrates that Cortina suffered some neurologic impairment, as a consequence of events at or about the time of her readmission to the hospital on September 11, 1992, it is quite unrevealing as to the severity of that impairment. Consequently, the proof fails to support the conclusion that any neurologic injury Cortina suffered rendered her permanently and substantially mentally and physically impaired. Regarding the timing and cause of Cortina's neurologic injury, the proof is compelling that, notwithstanding the circumstances of her delivery, Cortina was, at birth, a normal, vigorous infant, with no apparent abnormalities. Her development thereafter was likewise uneventful, until one to two days prior to September 11, 1992, when she was readmitted to the hospital, at approximately five weeks of age. In the opinion of Lance Wyble, M.D., a board certified neonatologist, Cortina's presentation on September 11, 1992, was most consistent with a viral etiology which, given her history, had its genesis within the 24 to 48 hour period immediately preceding her admission on September 11, 1992. It was further Dr. Wyble's opinion that such was the most likely cause of any neurologic injury Cortina suffered, and that any injury she suffered was wholly unrelated to the birthing process or her delivery. Of a similar opinion was Charles Kalstone, M.D., a board certified obstetrician. The opinions of Doctors Wyble and Kalstone are grossly consistent with the proof of record regarding Cortina's birth and her subsequent readmission to the hospital on September 11, 1992, and are credited.
The Issue Did Respondent's failure to intervene in the post-operative period immediately after learning the CT scan results of Patient C.O. near midnight on April 12, 1997, constitute treatment that fell below the standard of care and that he failed to practice 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, in violation of Section 458.331(1)(t), Florida Statutes?
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine in Florida. Respondent is a licensed physician in the State of Florida at all times material to the times alleged in the Complaint, having been issued license number ME 0070668. Respondent, as of May 2001, is board-certified in the area of neurological surgery. On April 3, 1997, Patient C.O., a 50-year-old male, presented to an Otolaryngologist (ear, nose and throat surgeon) with complaints of right side nasal polyps. On April 7, 1997, Patient C.O.'s surgeon ordered a radiological consult and a Coronal CT (up, down, front and back) scan of the right maxillary sinus. The CT scan revealed "complete opacification (blockage) of the left frontal, right ethmoid, right maxillary sinus, as well as the right nasal cavity with complete opacification of right sphenoid sinus." On April 9, 1997, Patient C.O. underwent a surgical procedure to remove nasal polyps. The surgeon removed an extremely large right nasal polyp, measuring approximately 10 cm in length. After removing the large mass, the surgeon noted smaller polyps and removed these also. After removing the polyps, the surgeon noted a "large pulsatile mass," which he biopsied. Biopsy results indicated that the "mass" was brain tissue. During the course of this procedure, the patient's cribriform plate had been pierced. This plate forms a barrier between the nasal cavity and the base of the brain. As a result of this puncture, the surgeon had removed a portion of Patient C.O.'s brain. The surgeon requested an intraoperative consult with Respondent. The surgeon and Respondent talked by telephone and Respondent recommended sealing off the brain tissue with a surgical flap and packing. An arteriogram was performed on Patient C.O. to determine if bleeding was from an artery or vein. It was determined that the bleeding was from a vein. He also, recommended placing Patient C.O. in the neurological intensive care unit, which was done, and the patient was stabilized. A CT scan, ordered by the surgeon, noted a right frontal hemorrhage and pneumoncephalus (air at the top of the skull). On April 10, 1997, drainage was noted from the right nostril of Patient C.O. Respondent noted that drainage was suspicious for cerebrospinal fluid (CSF). Respondent then considered various options in order to stop the leakage of CSF. On April 10, 1997, Respondent performed a surgical procedure which placed a spinal drain in Patient C.O. to control the intracranial pressure and to permit an outlet for the CSF. Respondent was attempting to allow the rupture to the cribriform plate to heal on its own. On April 11, 1997, a CT scan revealed large areas of air in the frontal areas of the skull. On April 12, 1997, it was determined that the rupture of the cribriform plate had not healed on its own. Patient C.O. had persistent drainage from the right nostril. He was taken to the operating room for a direct intracranial surgical repair of the defect. A CT scan demonstrated an increase in the frontal hemorrhage, a large left subdural hematoma, and brain swelling. On the afternoon of April 12, 1997, Respondent performed a bi- frontal craniotomy on Patient C.O. to close off the leaking of spinal fluid from the brain in the area behind the patient's forehead (CSF leak). The surgery began at 12:15 p.m. and anesthesia was initiated at approximately 12:30 p.m. on April 12, 1997, and surgery concluded at about 5:00 p.m. The procedure involved making an incision across the top of the scalp, from ear to ear, gaining access to the brain by making incisions in the cranium, then lifting the brain to allow access to the cribriform plate. This was accomplished without incident. During the post-operative period, the anticipated reaction of the patient was to return to post-operative status, or to improve neurologically beginning within two hours after the surgery ended. During the course of post-operative care, Patient C.O.'s vital signs and neurological statistics were constantly monitored. Patient C.O. did not show any improvements several hours after surgery as would be expected, but began to show signs of neurological deterioration. Because Patient C.O. did not improve neurologically after the surgery, Respondent, at about 9:30 p.m. on April 12, 1997, ordered a CT scan to be done immediately. Patient C.O. was taken for his CT scan around 10:45 p.m. The CT scan report by radiologist at Florida Hospital was called in to the hospital unit at 11:50 p.m. on April 12, 1997. Respondent was at home in bed, sleeping, when he was paged. Respondent called in and was told by telephone of the "wet read" results of the CT scan by the neuroradiologist. After obtaining the CT scan report, Respondent disagreed with the neuroradiologist's recommendations, ordered the continuation of the interventions which he had previously ordered, and issued no new medical orders. The April 12, 1997, CT scan results were reduced to writing and showed the following findings, when compared to the CT scan taken of Patient C.O., on April 11, 1997: Noncontrast examination shows numerous abnormal findings. Compared to the 04/11/97 study acute left subdural hemorrhage is similar. There is a large intraparenchymal frontal hemorrhage that has a similar appearance . . . . DIFFUSE INTRACEREBRAL SWELLING PROBABLY WORSE IN THE POSTERIOR FOSSA. OBLITERATED FOURTH VENTRICLE. VENTRICLE SIZE SIMILAR. INCREASED BLOOD FRONTAL REGION. UNCHANGED SUBDURAL LEFT POSTERIOR PAREITAL REGION. VENTRICULAR SIZE STABLE. PNEUMOCEPHALUS UNCHANGED. INTRAVENTRICULAR BLOOD STABLE. At 5:15 a.m. on April 13, 1997, Patient C.O.'s neurological status took a significant turn for the worse. The patient was interbated, and all appropriate measures were taken to attempt to revive the patient. Patient C.O. lapsed into coma and was unable to breathe sufficiently for himself; he sustained respiratory failure and coma. In the early morning hours of April 13, 1997, Patient C.O's neurological status was discussed with his family, and the decision was made to execute a do-not- resuscitate order. The patient never recovered and died two days later on April 15, 1997. Petitioner alleges that the standard of care required Respondent to take some affirmative or new action to intervene post-operatively on the night of April 12 through 13, 1997, to determine the cause of the deterioration and prevent irreversible brain damage. In support of Petitioner's position with regard to Respondent's standard of care, it presented the testimony of Dean C. Lohse, M.D. Dr. Lohse is a board-certified neurosurgeon who is licensed to practice medicine in the State of Florida. Dr. Lohse is a similar health care provider to Respondent, and he qualifies as an expert witness under Florida law. Dr. Lohse testified that he had several criticisms of the manner in which Respondent managed Patient C.O.'s post-operative care. Dr. Lohse was critical of the manner in which Respondent reacted to the information which was provided to him regarding the CT scan which was taken on the night of April 12, 1997, and which was communicated to Respondent at approximately midnight on that same night. In response to this information, Dr. Lohse was of the opinion that Respondent should have initiated some new intervention, including returning Patient C.O. to surgery, initiating medications to reduce swelling, introducing a pressure monitor, or changing the position of the lumbar drain. However, during the course of cross-examination, Dr. Lohse conceded that he could not say whether a return to surgery would have resulted in a different outcome for Patient C.O. Likewise, he could not state to within a reasonable degree of medical probability whether the introduction of medications to reduce the swelling would have worked. He could not state within a reasonable degree of medical probability whether the placement of a pressure monitor would have created a different result. Finally, he conceded that the issue of changing the lumbar drain was best left to the clinical judgment of the physician who is presiding over the care of the patient. Respondent testified on his own behalf at the final hearing. Respondent explained the April 12, 1997, craniotomy which he performed. He also explained the course of treatment which was followed with Patient C.O. in the hours subsequent to the conclusion of the craniotomy. Respondent explained his rationale behind ordering a stat CT scan, and he described the basis for his response to the information received at that time. Respondent testified that although he considered a return to surgery based upon the information contained within the CT scan, he decided against this option, as performing another surgery would only have been for the purpose of removing additional portions of Patient C.O.'s brain, including areas of the brain which are designed to control significant elements of an individual's personality. Respondent made the determination at that time that performing another surgical procedure would likely have caused more harm than good. Respondent testified that brain swelling reducing medication had been introduced previously and that the introduction of more or different brain swelling-reducing medications would not have addressed Patient C.O.'s condition. Respondent testified that the placement of a pressure monitor would have been pointless, given the information which he was able to obtain during the course of the craniotomy procedure. A pressure monitor is designed to measure increased levels of pressure on the brain. Patient C.O. was suffering from the opposite problem. Patient C.O.'s brain was actually flaccid, suffering from an absence, rather than an overabundance, of pressure. Therefore, the placement of a pressure monitor was never considered, as it would not have been of any use under the circumstances. Respondent testified that there was no need to change the aspect of the lumbar spinal drain. The lumbar spinal drain in this particular case was adequately controlled, at 5 ccs per hour. Thus, the use of the spinal drain was appropriate under the circumstances. Respondent's testimony is credible. Respondent also presented expert testimony, via deposition, of R. Patrick Jacob, M.D. Dr. Jacob is a board- certified neurosurgeon who currently works at the University of Florida in Gainesville. Dr. Jacob testified as to his education, training, and experience. He is a similar health care provider to Respondent, qualifies as an expert under Florida law, and can render expert medical opinions regarding the applicable standard of care in this case. Dr. Jacob testified that in his opinion, to within a reasonable degree of medical probability, Respondent met the applicable standard of care. He addressed each of the specific criticisms raised by Dr. Lohse. He specifically rejected the idea that another surgical procedure should have been performed, stating that to do so would have done more harm than good. He rejected Dr. Lohse's contention that the introduction of additional medications to reduce swelling would have been appropriate. Dr. Jacob disagreed with Dr. Lohse's suggestion that the placement of a pressure monitor would have been appropriate under the circumstances of this case. Finally, Dr. Jacob took issue with Dr. Lohse's opinion that a change in the lumbar spinal drain was warranted given Patient C.O.'s condition. On cross-examination, Dr. Jacob testified that he felt that Respondent's response to the information contained within the April 12, 1997, CT scan was appropriate. He was then presented with hypothetical questioning regarding whether doing nothing in response to the information contained within the CT scan would have been appropriate. Dr. Jacob testified that doing nothing in response to the information contained within the CT scan report may have constituted a deviation from the accepted standard of care. However, according to Dr. Jacob's review of the records, and Respondent's testimony at the final hearing, it is apparent that a decision was made by Respondent to continue with the interventions which had already been initiated, which under the circumstances of this case constitutes an affirmative act by Respondent to address the treatment and care of Patient C.O. Dr. Jacob's testimony is both credible and persuasive. The evidence is not clear and convincing that Respondent failed to intervene in the post-operative period immediately after learning the CT scan results of Patient C.O. around midnight on April 12, 1997. Respondent did not fail to take appropriate action after learning the results of the CT scan at midnight on April 12, 1997. Respondent ruled out several options and elected to continue with the interventions already initiated. Therefore, Respondent did not fall below the standard of care for similarly situated neurosurgeons and his actions on April 12 through 13, 1997, did not constitute a failure to practice medicine with that level of skill, care, and treatment recognized by a reasonably prudent similar neurosurgeon as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Medicine issue a final order finding that Respondent has not violated Section 458.331(1)(t), Florida Statutes, and dismissing the Administrative Complaint. DONE AND ENTERED this 19th day of July, 2002, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 19th day of July, 2002. COPIES FURNISHED: Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Post Office Box 2753 Orlando, Florida 32802-2753 Shirley J. Whitsitt, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 39-A Tallahassee, Florida 32308 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issue is whether the Dynamic Orthotic Cranioplasty band and related services to correct cranial asymmetry in a one-year- old child are covered benefits under the State of Florida State Employees' self-insured health plan.
Findings Of Fact At all material times, Petitioner Andres Gil has been a professor employed at Florida International University in Miami. At all material times, he has been a participant in the state group insurance programs, including the state group health insurance plan (Plan). The plan's benefits are described in the State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document (Benefit Document). At all material times, Petitioner's child, S. G., who was born on April 15, 2002, was a covered dependent under the Plan. At birth, S. G.'s skull appeared normal, but, at about two months of age, she began to exhibit a slight flattening of the head. The flattening became more pronounced by four months of age. The flattening was probably due to positioning of the infant at night so that she would sleep on her back and presumably be safer from sudden infant death syndrome. Petitioner and his wife took S. G. to a pediatrician, who diagnosed S. G. with severe bilateral deformational plagiocephaly. The pediatrician confirmed that S. G.'s condition was not congenital. After trying unsuccessfully conservative treatment, the pediatrician recommended the Dynamic Orthotic Cranioplasty band. This device is called a DOC Band?. The DOC Band? is among the type of devices that attempt to reshape the skull of infants through the application of focused pressure on the still-forming skull. The U.S. Food and Drug Administration has approved 38 such devices, and many of them have been used for many years. These devices include rigid helmets, which are initially fitted, but not later adjusted, and more-flexible bands, which are adjusted periodically during the period that the infants wear them. S. G. first wore the DOC Band? for four months, starting in May 2003. Although she received little benefit from the device, Petitioner, his wife, and the pediatrician decided to give the device another try, starting in September or October 2003. During the second application of the DOC Band?, which ended in February 2004, S. G.'s skull asymmetry reduced substantially. When the pediatrician first prescribed the DOC Band?, Petitioner submitted a claim to Blue Cross Blue Shield of Florida (BCBSF), which is the third-party administrator of the Plan. BCBSF denied the claim, and Petitioner appealed this decision to Respondent. By letter dated October 24, 2003, Respondent informed Petitioner that it was sustaining the determination of BCBSF. The letter states that the service or procedure was "experimental or investigational" or "not in accordance with generally accepted professional standards." On December 15, 2003, Petitioner filed a letter requesting a formal hearing. However, he never filed a claim for the second application of the DOC band. The Benefit Document lists under the "Summary of Plan Benefits" an "overview" of the "services and supplies" that are covered by the Plan. Benefit Document, p. 11. The "Summary of Plan Benefits" states that the Plan pays a percentage of the cost of "covered care and medical supplies," as long as the "care or supplies" are ordered by a covered physician and are "medically necessary" for treatment as a result of a covered accident, illness, condition, or mental or nervous disorder. Id. The Benefit Document generally covers "doctor's care" and "durable medical equipment." Benefit Document, p. 12. However, under "Limitations and Exclusions," the Benefit Document does not cover: "Services and procedures considered by BCBSF to be experimental or investigational, or services and procedures not in accordance with generally accepted professional medical standards, including complications resulting from these non-covered services." Benefit Document, p. 31. The Benefit Document defines "investigational or investigational services" as "any evaluation, treatment, therapy or device that:" cannot be lawfully marketed without approval of the US Food and Drug Administration or the Florida Department of Health if approval for marketing has not been given at the time the service is provided to the covered person is the subject of ongoing Phase I or II clinical investigation, or the experimental or research arm of a Phase III clinical investigation--or is under study to determine the maximum dosage, toxicity, safety or efficacy, or to determine the efficacy compared to standard treatment for the condition is generally regarded by experts as requiring more study to determine maximum dosage, toxicity, safety or efficacy, or to determine the efficacy compared to standard treatment for the condition has not been proven safe and effective for treatment of the condition based on the most recently published medical literature of the US, Canada or Great Britain using generally accepted scientific, medical or public health methodologies or statistical practices is not accepted in consensus by practicing doctors as safe and effective for the condition is not regularly used by practicing doctors to treat patients with the same or a similar condition BCBSF and [Respondent] determine whether a service or supply is experimental or investigational. The first two bullets of the above-cited definition of experimental or investigational services are not at issue in this case. The U.S. Food and Drug Administration has approved the DOC Band?, and it is not presently under clinical investigation or otherwise under study to determine its efficacy compared to other treatments. Nor is the safety of the DOC Band? at issue. Premature use, which is not applicable in this case, may present certain risks. Otherwise, the main risk is minor skin irritation, which obviously may be monitored. Thus, no substantial, unavoidable safety issues emerge in the use of the DOC Band? in this case. In addition to raising safety concerns, the third and fourth bullets of the above-cited definition of experimental or investigational services raise the issue of the efficacy of the DOC Band?. In 2003, the American Academy of Pediatrics released a position paper on the management of skull deformities in infants and reached no firm conclusions about the efficacy of cranial orthoses. However, a significant number of physicians find the DOC Band? to be effective in treating deformational plagiocephaly. The fifth and sixth bullets of the above-cited definition of experimental or investigational classify the DOC Band? as experimental or investigational if it is not accepted in "consensus" by practicing doctors as effective or if it is not "regularly used" by practicing doctors to treat deformational plagiocephaly. "Consensus" is defined as: "1.a. general agreement: UNANIMITY . . . [,] b. the judgment arrived at by most of those concerned[,] and 2. group solidarity in sentiment and belief." Merriam-Webster's Collegiate Dictionary (Tenth Edition 1999). Respondent has proved that DOC Band? has failed to reach these levels of acceptance and use. Although insureds may be absorbing the cost of DOC Bands? without filing claims, the fact that the Plan has received one claim for a DOC Band? in 2004 and one claim for a DOC Band? in 2003 militates against a finding of regular use, if not also widespread acceptance, of the device. Although significant numbers of physicians find the DOC Band? to be effective in treating deformational plagiocephaly, the record reveals disagreement in the acceptance of the DOC Band? and suggests that practitioners do not regularly use the device to treat deformational plagiocephaly. The research articles on which Petitioner relies assist in determining the efficacy of the DOC Band?, but do not assist in finding, at the practitioner level, the extent of acceptance and use of the device. The medical group endorsements suggest an invitation to the use of the DOC Band?, but assist little in finding the acceptance of the device by practitioners and do not assist at all in finding the extent of use of the device by practitioners. Against this evidence, the scant number of claims and the testimony of Respondent's expert witness to similar effect establish that the DOC Band? meets the fifth and sixth definitional bullets of experimental or investigational services.
Recommendation It is RECOMMENDED that Respondent enter a final order denying Petitioner's claim to the Plan for payment for the DOC Band? and related services. DONE AND ENTERED this 22nd day of November, 2004, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 22nd day of November, 2004. COPIES FURNISHED: William Simon, Secretary Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950 Alberto Dominguez, General Counsel Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950 Andres G. Gil 206 Cameron Court Weston, Florida 33326 Sonja P. Mathews Assistant General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 260 Tallahassee, Florida 32399-0950
The Issue The issue for determination at formal hearing was whether Respondent committed the offenses set forth in the administrative complaint, and, if so, what action should be taken.
Findings Of Fact The Department of Professional Regulation (now, the Agency for Health Care Administration), Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material hereto, Arthur J. Schatz, M.D. (Respondent), has been a licensed physician in the State of Florida, having been issued license number ME 0024745. On or about September 7, 1988, Patient A. H., a 61-year-old female, presented to her internist with complaints of left pelvic pain. The internist ordered a pelvic sonogram and an MRI. Both procedures revealed a five centimeter mass on the left side of Patient A. H.'s pelvis. The internist referred Patient A. H. to Respondent. On or about September 16, 1988, she presented to Respondent who performed an examination by palpation, which revealed a mass on the left side of her pelvis. Respondent diagnosed Patient A. H. as having a left ovarian tumor. Respondent scheduled Patient A. H. for exploratory laparotomy and probable total abdominal hysterectomy and bilateral salpingo-oophorectomy. Exploratory laparotomy is a surgical procedure in which a patient's abdomen is opened to explore the abdominal cavity in order to determine whether there is any pathology present. Exploratory laparotomy was indicated, and Respondent was qualified and credentialed to perform the surgical procedure. Because of the location of the mass and because of Patient A. H.'s history, especially her age, pre-operatively, Respondent believed that the mass was highly suggestive of a malignancy. Respondent did not perform or order any other diagnostic test or seek any consultation with any other physician or any specialist. Such conduct by Respondent was within the acceptable standard of care, skill, and treatment in the practice of medicine. On or about September 25, 1988, Respondent admitted Patient A. H. to Parkway Regional Medical Center for the surgical procedure to be performed. On or about September 26, 1988, Respondent performed the exploratory laparotomy. Upon entering Patient A. H.'s abdomen, Respondent took washings. Respondent then proceeded to examine her female organs and discovered that they were normal. Continuing, Respondent palpated the mass on the left side of Patient A. H.'s pelvis in the retroperitoneal area, behind a very thin layer of tissue called the peritoneum. Pre-operatively, Respondent could not have known that the mass was retroperitoneal. The overwhelming majority, ninety-eight percent, of gynecologic surgery is performed on the intra-peritoneal structures, while only two percent is performed retroperitoneally. General gynecologists are trained to and do perform surgical procedures retroperitoneally. Respondent appropriately elected to open the peritoneum and entered the retroperitoneal space to identify and surgically address the area of suspected pathology. He found a somewhat soft mass, approximately five centimeters in diameter, on the pelvic side wall with a white structure running through the middle of the mass. The mass, a tumor, which was encapsulated was round in shape and yellowish in color. Encapsulation is more commonly associated with benign tumors than malignant tumors. Unsuccessfully, Respondent attempted several times to dissect the mass off the white structure. Respondent recognized the white structure as the obturator nerve which was later identified as such. Respondent observed that the mass had the general appearance of a lymphoma which is a benign, fatty, slow-growing tumor. However, he was unable to precisely identify the nature of the mass which could also have been lymphosarcoma, malignant, since no analysis had been performed on the mass. Respondent believed that the tumor was more likely benign than malignant. Confronted with a most unusual situation in that the tumor was in a very unusual location and the obturator nerve was within the mass itself, Respondent requested that the entire hospital be paged for a gynecologic oncologist. He was informed that neither of the two gynecologic oncologists on the hospital staff were in the hospital or scheduled to be in the hospital. Respondent's act of not having a gynecologic oncologist present or on call during the scheduled surgery was not practicing medicine below the acceptable standard of care, skill, and treatment. Respondent then requested the paging of a general surgeon. A board certified general surgeon responded and entered the operating suite where Respondent was operating on Patient A. H. The general surgeon did not scrub to assist Respondent but came into Respondent's operating suite and viewed the operating field. He advised Respondent that he had never seen a condition like that of Patient A. H. and could offer no suggestions. Getting no assistance from the general surgeon, Respondent requested that a neurosurgeon or orthopedist be called. A board certified orthopedist was in surgery in an adjacent operating suite. Respondent broke scrub, left his operating suite and entered the orthopedist's operating suite. He questioned the orthopedist regarding the function of the obturator nerve and the anticipated effect of sacrificing the nerve, if that were necessary, in order to remove the tumor in its entirety. The orthopedist advised Respondent that the obturator nerve was a major nerve which governs the muscles involved in the adduction of the thigh and affects the ability to walk. He further advised Respondent that sacrificing the nerve should result in only a minimal disability which could be adequately addressed with physical therapy. Generally, a general gynecologist, including Respondent, has a cursory understanding of the function of the obturator nerve. Arising from the lumbar section of the spinal column, the obturator nerve is a major nerve and is extremely important in allowing a person's legs to move to the midline for the purpose of walking. After being advised by the orthopedist, Respondent re-scrubbed and returned to his operating suite. He again attempted, without success, to dissect the tumor from the obturator nerve. Thereupon, Respondent decided that Patient A. H. would benefit from a complete resection of the tumor even though it would mean sacrificing the obturator nerve in order to remove the tumor in its entirety. He had no experience in the removal of lymphomas from nerves. Respondent appropriately decided against performing a frozen section on the tumor, prior to removal, because such a procedure might expose Patient A. H. to the risk of cancer cells being spread through the retroperitoneal space if the tumor was malignant. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. A frozen section is a procedure in the intraoperative period 2/ in which a surgeon attempts to remove a piece of a tumor or mass to send to a pathologist to determine whether the mass is malignant or benign. The procedure is important because it provides the surgeon with direction as to how to proceed in terms of treatment and care of a patient while the patient is under anesthesia and in the operating room. Furthermore, Respondent appropriately decided against removing only portions of the tumor, thereby leaving some of it behind, because such a procedure could result in the tumor re-growing, and possibly as a malignancy. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. Respondent removed the tumor in its entirety which included removing the portion of the obturator nerve to which the tumor was attached to and incorporated within the tumor. Respondent sent the specimen to the pathology lab for analysis which revealed that the tumor was a fatty, benign lymphoma and that the white structure incorporated within the tumor was nerve tissue. Prior to removing the tumor in its entirety, there was no acceptable method available to Respondent for him to definitively know that the tumor was benign. Respondent failed to record his contacts with the general surgeon and the orthopedic surgeon in his operative notes for the surgery but recorded the contacts in his discharge summary. It is customary and appropriate to record intra-operative consultations in an operative report. Neither the general surgeon nor the orthopedist considered their contact with Respondent as a consultation. Patient A. H.'s postoperative recovery was not as anticipated in that she suffered severe, instead of minimal, disability which has affected her ability to walk. She is unable to walk without the assistance of either a cane or a leg brace. No literature or authority exists which supports the sacrifice of the obturator nerve for a benign tumor or a tumor which appears to be benign. Patient A. H.'s condition was a rare case because of the location of the tumor and because the tumor was attached to the obturator nerve which was incorporated within the tumor. Neither the expert for Petitioner nor for Respondent had ever experienced, or heard or read of such a situation. Furthermore, because of Respondent's experience with Patient A. H. and her resulting condition, both experts have greater knowledge of the obturator nerve. Respondent's removal of the tumor in its entirety, including removing a portion of the obturator nerve, was within the acceptable standard of care, skill, and treatment in the practice of medicine.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency For Health Care Administration, Board of Medicine, enter a final order dismissing the administrative complaint. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 2nd day of December 1994. ERROL H. POWELL 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 2nd day of December 1994.
The Issue The issues to be determined are whether Respondent, John Carey Tomberlin, M.D. (“Respondent” or “Dr. Tomberlin”), violated section 458.331(1)(t)1., Florida Statutes (2014), by failing to identify a subdural hematoma on the left side of Patient J.A.’s brain, as alleged in the Administrative Complaint; and if so, what penalty should be imposed.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and the entire record of this proceeding, the following Findings of Fact are made: Parties Petitioner is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this proceeding and Petitioner’s Administrative Complaint, Respondent was licensed to practice medicine in the state of Florida, having been issued license number ME 60438. Respondent’s practice address of record is 2600 Hospital Drive, Bonifay, Florida 32425. Respondent, a board-certified radiologist, has been practicing since 1987. Respondent attended University of Alabama for medical school and is also licensed in that state. He has worked in rural areas in covering a variety of practice settings, including prisons, clinics, and hospitals. In his practice as a radiologist, he testified that he reviews 100 to 200 CT scans per week. Facts Related to Patient J.A.’s CT Scan On August 29, 2014, Patient J.A., a seventy-four year old male, presented to Doctor’s Memorial Hospital in Bonifay, Florida. Patient J.A. presented with a history of suffering a physical attack including being struck over the head with a chair and being repeatedly punched in the head. The attack resulted in complaints of dizziness and a contusion on the left side of the head. To fully assess the injury sustained during the attack, Patient J.A. underwent a CT scan of the head without contrast. Respondent was tasked with interpreting the CT scan. On August 29, 2014, Dr. Tomberlin dictated a report of his findings as follows: “Bone and soft tissue windows are included. Soft tissue density can be seen within some of the paranasal sinuses. The calvarium is intact. The ventricles are symmetrical. Pineal calcifications are noted. There is no acute hemorrhage, midline shift, mass effect or extra-axial fluid collection.” His opinion was as follows: “(1) Negative CT brain scan; and (2) Minimal sinusitis with both acute and chronic elements noted.” On August 29, 2014, Respondent did not detect a subdural hematoma in the CT scan images of Patient J.A.’s head. A subdural hematoma is a collection of blood in the head on the outside of the brain beneath the dura, a fibrous lining of the brain. Patient J.A. died on September 16, 2014. Dr. Tomberlin acknowledged that he did not perceive the hematoma at the time of his initial review, despite exercising due care in his review of the CT scan. He explained that he missed the hematoma due to several factors: there was no indication of a midline shift; hyperdensity was white and dense in comparison to the rest of the brain tissue; the brain was very large; and the size (described as small) of the subdural hematoma. He noted that while elderly patients are at a higher risk for subdural hematoma, Patient J.A. had a healthy and larger brain despite his age. Dr. Tomberlin testified that after he learned that Patient J.A. had died, he performed a post-mortem review of the CT scan and discovered the subdural hematoma. Expert Witnesses Dr. Andriole The Department presented the testimony of Joseph Gerald Andriole, M.D. Dr. Andriole was accepted as an expert in diagnostic radiology. Dr. Andriole is a board-certified diagnostic radiologist with a subspecialty in interventional radiology. He has been licensed to practice medicine in Florida since 1986. He attended Howard University School of Medicine and completed his residency in diagnostic radiology at Case Western Reserve University Hospital. Dr. Andriole is not trained in and is not board certified in neuroradiology. Since reducing his full-time practice to three to four days per month in 2012, Dr. Andriole reviews approximately 15 CT scans of the head per month in an outpatient setting. Dr. Lursen Respondent presented the testimony of Katherine Perrien Lursen, M.D., who was accepted as an expert in diagnostic radiology. Dr. Lursen, a diagnostic radiologist, is licensed to practice medicine in Alabama. Dr. Lursen is not licensed to practice medicine in Florida, but she maintains an expert witness certificate, having been issued certificate number MEEW6548, which authorizes her to testify in Florida cases. For the reasons set forth herein, she is also familiar with the standards of reviewing CT scans. Dr. Lursen earned her medical degree from the University of Alabama at Birmingham and completed her residency in radiology. She also completed a fellowship in neuroradiology. Dr. Lursen is board certified in diagnostic radiology with a certification in the subspecialty of neuroradiology. Dr. Lursen has practiced diagnostic radiology for nine years. In her full-time practice, she services three hospitals as a neuroradiologist and reviews approximately 120 to 150 CT scans of the head each month. She serves as the chair of the radiology department at Mobile Infirmary, a 700-bed hospital in Mobile, Alabama, the largest hospital in Mobile. As the department chair, she helps develop protocols for radiology at Mobile Infirmary, including the appropriate method to interpret radiology images. Dr. Lursen also serves on a hospital peer-review committee and reviews cases where the standard of care is at issue. In addition to her practice related duties, Dr. Lursen teaches at the Alabama College of Osteopathic Medicine and instructs students during rotations. Allegations Related to the Standard of Care Dr. Andriole reviewed the hospital records for Patient J.A. for August 29, 2014, including the admission record that reflected Patient J.A. was “hit in the head” in the left temple area and a contusion was noted on the left temple. Dr. Andriole also reviewed the CT scan of Patient J.A.’s head and Respondent’s CT report. Based on his review of the CT scan, CT report, and hospital records, Dr. Andriole opined that Dr. Tomberlin departed from the standard of care by failing to identify the subdural hematoma on the left side of Patient J.A.’s brain. When the standard of care is at issue, the individual opinion of an expert witness does not establish the standard of care. The standard of care is based on the level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.3/ Petitioner’s expert, Dr. Andriole, was tasked with establishing the actions a reasonably prudent radiologist would exercise when interpreting a CT scan of the head. Dr. Andriole testified that “the standard of care states that a physician would provide the type of interpretation that would be expected from a competent, prudent physician at the time under similar circumstances.” He also testified that the standard of care required Dr. Tomberlin to identify “expected abnormalities” that result from the type of head injury or trauma suffered by Patient J.A. Based on the testimony at hearing, Dr. Andriole’s expert testimony fell short of establishing the standard of care a reasonably prudent physician would exercise under the circumstances to detect an abnormality. When addressing the standard of care, Dr. Andriole’s testimony was as follows: Q. What is the standard of care for a radiologist reviewing the CT scan of the head or brain? A. [T]he standard of care states that a physician would provide the type of interpretation that would be expected from a competent, prudent physician at the time under the circumstances. Dr. Andriole testified that a physician would provide the type of interpretation that would be expected, but failed to state standards upon which the undersigned could evaluate Dr. Tomberlin’s interpretation of the CT scan. Further, Dr. Andriole reached his opinion without regard to the findings in the CT report, which reflected Dr. Tomberlin’s assessment of the CT scan. In considering whether Dr. Tomberlin met the standard of care, Dr. Andriole testified that a reasonably prudent physician would consider the underlying cause of injury or trauma to aid in interpretation of the CT scan, which Dr. Tomberlin considered. Dr. Andriole acknowledged that the abnormality was smaller than average for a subdural hematoma. He also acknowledged that Dr. Tomberlin carefully reviewed the CT scan because he identified small abnormalities in the sinuses that were smaller than the subdural hematoma. Dr. Andriole agreed that the type of error in this case, a perceptional error, may still meet the standard of care. Dr. Andriole acknowledged that a three to five percent error rate can occur when reviewing radiology images. Dr. Lursen, on the other hand, opined that Dr. Tomberlin met the standard of care in his review of the CT scan for Patient J.A. Dr. Lursen pointed to Respondent’s interpretation of the CT scan and highlighted that his reference to absence of midline shift, absence of mass effect, and calvarium (being) intact show Dr. Tomberlin was looking for a subdural hematoma. Dr. Lursen credibly testified that when interpreting a CT scan of the head of a trauma patient, the standard of care requires a physician to look at several factors to detect an abnormality. Dr. Lursen testified that assessing whether there is a midline shift and mass effect is important because those are two signs of intracranial hemorrhage, including subdural hematoma. The standard of care also requires that the radiologist look for areas of hyperdensity because hyperdensity is an indicator of intracranial hemorrhage. Density refers to the amount of gray versus the amount of black and white on an image. If an image is hyperdense, then it is whiter than the surrounding or adjacent structure or tissue. The radiologist should determine whether there is a skull fracture. Finally, the radiologist should look for acute hemorrhage. Dr. Lursen noted that Respondent’s CT report reflected an appropriate assessment of care a reasonably prudent physician would exercise to detect a subdural hematoma. Despite the appropriate assessment, however, it is undisputed that Respondent failed to identify the subdural hematoma. Dr. Lursen opined that failure to identify the hematoma was not a departure from the standard of care due to its atypical appearance. Dr. Lursen considered the presentation of the subdural hematoma to be atypical because of its “tiny” size, and the absence of typical traits, “including, mass effect, midline shift, or injury to the skull in the CT images.” She testified that the density of the hematoma was closer to the shade of the brain mass and there was no skull fracture. Further, a classical subdural hematoma is C-shaped and causes a midline shift of the brain, which was not apparent on Patient J.A.’s CT scan. Dr. Lursen provided testimony that Respondent’s failure to identify the hematoma fell with an accepted three to five percent error rate. That error rate includes the presumption that the radiologist has conducted himself in a manner in interpreting the film or image that is prudent under the circumstances. According to Dr. Lursen, a radiologist can have a three to five percent error rate and still have met the standard of care. In this case, Dr. Lursen credibly testified that Respondent’s failure to identify the subdural hematoma fell within that three to five percent error rate, but he still met the standard of care. Dr. Lursen testified that Dr. Tomberlin’s error fell within the category of an observational or perceptual error. An observational or perceptual error occurs when a radiologist follows the appropriate method for reviewing images but does not perceive the abnormality upon initial review. Dr. Lursen’s opinion that Dr. Tomberlin’s failure to identify the subdural hematoma was a perceptual error, which did not fall outside the standard of care is credited. Ultimate Findings of Fact In determining whether Dr. Tomberlin met the standard of care, the question is not whether either of the experts could identify the abnormality, but whether Dr. Tomberlin used the degree of skill and care that a reasonably prudent physician in the medical community would exercise to detect the abnormality. To be convincing, the opinion needs to establish clearly the existence of a standard of care in the profession and explain how such standard applies to the facts of the case. An expert's opinion on the standard of care must result from an analysis of the facts to determine what a reasonably prudent physician in the radiology community would do given the circumstances. The undersigned finds in Dr. Lursen’s expert testimony that Dr. Tomberlin met the standard of care in his interpretation of Patient J.A.’s CT scan more persuasive than Dr. Andriole’s testimony.4/ Thus, the Department did not establish by clear and convincing evidence that Respondent violated the applicable standard of care in his interpretation of the CT scan of Patient J.A.’s head.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 21st day of January, 2020, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN 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 21st day of January, 2020.