Findings Of Fact Victoryia Williams was born on May 3, 2012, at North Shore Medical Center located in Miami, Florida. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Victoryia. In a report dated July 15, 2015, Dr. Willis described his findings in pertinent part as follows: Delivery was by spontaneous vaginal birth. Birth weight was 3,740 grams or 8 lbs 4 oz’s. Amniotic fluid was clear. The baby was not depressed at birth. Apgar scores were 9/9. The baby had a normal newborn hospital course. Admission physical exam in the nursery diagnosed “term newborn female.” Transition was stated to be “unremarkable.” The baby was out of the nursery and with the mother about 5 hours after birth. Records after hospital discharge indicate the child developed seizures at about 5 months of age. Genetic evaluation was done at about 14 months due to seizures and no genetic abnormalities were found. The baby was not dysmorphic. MRI at this time showed volume loss. In summary, prenatal course was uncomplicated. Labor was induced at 39 weeks. There was no fetal distress during labor. A variable FHR pattern developed just prior to delivery and would be considered fairly normal second stage of labor FHR pattern. This period of variable decelerations did not result in oxygen deprivation to the baby. The baby was delivered by spontaneous vaginal delivery and was not depressed at birth. The newborn hospital course was uncomplicated. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery, or the immediate post delivery period. In an affidavit dated July 17, 2015, Dr. Willis confirmed his opinion as stated in his medical report and opined as follows: It is my opinion that the prenatal course was uncomplicated. Labor was induced at 39 weeks. There was no fetal distress during labor. A variable FHR pattern developed just prior to delivery and would be considered fairly normal second stage of labor FHR pattern. This period of variable decelerations did not result in oxygen deprivation to the baby. The baby was delivered by spontaneous vaginal delivery and was not depressed at birth. The newborn hospital course was uncomplicated. As such, it is my opinion that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post delivery period. A review of the file in this case reveals that there have been no opinions filed that are contrary to the opinion of Dr. Willis that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain during labor, delivery or the immediate post-delivery period. Dr. Willis’ opinion is credited.
The Issue The issue in this case is whether Jeffrey D’Angelo, Jr. (Jeffrey), suffered a birth-related neurological injury as defined by section 766.302(2), Florida Statutes (2014), for which compensation should be awarded under the Florida Birth- Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact On February 22, 2014, in her 37th week of pregnancy, Petitioner, Katis D’Angelo, had a spontaneous rupture of her membranes. She presented to Bayfront and, at approximately 11:00 p.m., was evaluated in the labor suite. Upon initial examination, her cervix was noted to be “1 cm dilated, 50 percent effaced with the vertex at a -2 station.” The fetus’s heart tones were normal; however, Mrs. D’Angelo was not having an active labor pattern. Accordingly, Mrs. D’Angelo was admitted to the hospital. Dr. Dieffenbach had been Mrs. D’Angelo’s obstetrician throughout her pregnancy and, upon admission to Bayfront, was the primary and attending obstetrician. To assist in the progression of her labor, Dr. Dieffenbach ordered a low dose of Pitocin. Mrs. D’Angelo’s labor progressed and her cervix dilated to about five centimeters; however, it “got hung up for about 5 hours.” She was reexamined about an hour later with no changes noted. Due to her failure to progress, Dr. Dieffenbach recommended a Cesarean section delivery. Dr. Dieffenbach’s Clinical and Operative Notes provide, in pertinent part, as follows: CLINICAL NOTE: . . . At this point, cesarean delivery was recommended. Risks were explained and accepted. The labor was dysfunctional. Pitocin was up to about 14 milliunits. The fetal heart tones were in the normal range, but failed to show a great deal of variability. No decelerations were noted. Fluids were changed to D5 and Ringers to see if that would help stimulate the baby. OPERATIVE NOTE: . . . Uterine incision was extended laterally by stretching. The baby was noted to be in a ROT position. The infant was LGA, weighing 7 pounds 14 ounces at 37 weeks. The extraction was difficult. This was a male weighing 7 pounds 14 ounces, 3575 grams. Apgars were 2, 6, and 8. The infant was noted to have cord wrapped around the legs with several loops and also around the abdomen, possibly accounting for the fetal heart rate changes. The nares and orpharynx were suctioned with bulb syringe. Cord was clamped and severed. The infant was given to the nurse for further care at the isolette . . . . Both mother and baby did well. The baby is currently in the NICU, stable. Jeffrey was born at 1:52 p.m., on February 23, 2014. At delivery, he was noted to be “depressed.” At one minute of life, Jeffrey’s Apgar score was a 2.1/ A Neonatal Intensive Care Unit (NICU) Registered Nurse (RN) was requested to provide assistance in the operating room and the RN arrived within four minutes. Due to his depressed state, resuscitative efforts were required in the first several minutes of life. These efforts included positive pressure ventilation (for five minutes), oxygen, and chest compressions for 30 seconds. It appears the resuscitative efforts were administered by the respiratory therapist and operating room nurse prior to the NICU RN’s arrival.2/ The NICU RN documented that, upon arrival, Jeffrey had poor color and tone. By his tenth minute of life, Jeffrey had responded well to the oxygen, his color had improved, and he had spontaneously cried. At 2:10 p.m., Jeffrey was transitioned and admitted to the Bayfront NICU. At the NICU, Jeffrey was noted to have decreased tone, facial bruising, petechiae, and a low blood glucose level. He was noted to have a strong suck (for feeding), however, he had desaturations during feeding attempts, with a recorded apnea. At 3:45 p.m., Jeffrey was noted to have a significant apneic episode (ceased breathing for more than 15 seconds), he became cyanotic, and “very aggressive stimulation was needed,” in addition to mask oxygen. At that time, his oxygen saturation level was low at 58. At approximately 7:00 p.m., Jeffrey was placed on a nasal cannula for oxygen (vapotherm 2 LPM 23%). Jeffrey had several additional apneic episodes during his first day of life. On three occasions, the apnea lasted for more than 15 seconds, he became cyanotic, and required gentle or vigorous stimulation. Due to these incidents, on February 24, 2014, an echoencephalograph (EEG) was performed. The EEG finding and impression were as follows: FINDING: Transcranial head ultrasound was performed with gray scale imaging via anterior fontanelle. This demonstrates normal brain parenchymal echogenicity. There is a normal germinal matrix and cord plexus. There is no hydrocephalus or intraparenchymal hemorrhage. Impression: Normal transcranial head ultrasound as above. Jeffrey remained at the Bayfront NICU until March 5, 2014. During his NICU stay, he had a cranial ultrasound which was interpreted as normal; he was noted as having frequent arching and possible posturing; and continued to have poor feeding coordination. On March 5, 2014, he was transferred to All Children’s Hospital to obtain a brain MRI, neurology consultation, and a speech therapy consultation. On March 6, 2014, the brain MRI was conducted. The MRI was interpreted as showing a brain with normal signal intensity, including gray and white matter on multiple sequences. Ultimately, Jeffrey was discharged from All Children’s Hospital after approximately three days.3/ Following his discharge, Jeffrey exhibited developmental delays. When Jeffrey was approximately nine months old, he was evaluated by Elizabeth Barkoudah, M.D., the attending physician for the Neurodevelopmental Disabilities Department at Children’s Hospital in Boston, Massachusetts. Her report documents his post discharge history as follows: Concerns with Jeffrey were first noted in the neonatal period given low tone. This has prompted him to be seen by various specialties in Florida including Neurology, Neurosurgery, Physiatry, Genetics, Ophthalmology and Neuro-opthalmology. He has had a head ultrasound at 5 months of age which showed increased frontal lobe fluid. A brain MRI was repeated at 7 months of age including a cervical MRI. Again this showed the increased fluid. He was seen by Neurosurgery who did not feel that shunting was needed. His cervical MRI showed some narrowing with persistent SCF flow around the spinal cord. This MRI was obtained after papillodema was found on his examination. This examination was recommended due to “choppy visual tracking.” Over time it was felt that this was not truly papilledema and is simply elevated optic nerves. Visual assessment at the time showed weaknesses left more than right. In regards to evaluations, he has also been seen by Genetics who has obtained a chromosomal microarray which was unremarkable. He had thyroid testing and CPK levels which were normal. He has been seen by Physiatry who recommended ongoing therapy. They have provided him with a Benik trunk brace which now he only uses with exercises. He has been receiving Early Interventions services including PT two times per week, OT one time per week and speech therapy one time per week. Dr. Barkoudah’s impression was that Jeffrey’s low muscle tone was “likely central in origin and related to his gross motor delays.” She did not recommend any further assessments. Dr. Barkoudah opined in her report that the average age for diagnosis of cerebral palsy is two years of age, and, therefore, Jeffrey did not currently meet the diagnostic requirement. At approximately 13 months of age, Jeffrey was referred to Radhakrishna K. Rao, M.D., D.C.H., M.S., at Bay Regional & International Institute of Neurology, for a neurological evaluation. After conducting an examination of Jeffrey, Dr. Rao’s report documented his clinical impression as follows: Patient has a complex medico-neurological condition of severe complexity. Patient had difficult neonatal period as described above. Developmentally child is making progress at a slower pace without any regression. In my opinion, the loose umbilical cord wrapped around his legs and abdomen may have contributed to initially for persistent transverse lie and later descent for normal vaginal birth. This also might have contributed for respiratory depression and low Apgar score resulting in intermittent hypoxia. This appears to be the reason for his development of generalized hypotonia, gross motor and fine motor developmental delay and hypotonic cerebral palsy. Dr. Rao recommended an additional EEG to document any underlying neuronal dysfunction and seizure activity. An EEG was conducted several days later and was interpreted as within normal limits for Jeffrey’s age, and there was no definite seizure activity seen. Jeffrey presented to Dr. Rao again on April 21, 2015. On this occasion, among other medical concerns, Dr. Rao diagnosed Jeffrey with hypotonic cerebral palsy. Jeffrey continued to treat with Dr. Rao through August 2015. On June 21, 2017, Jeffrey (at age three years, four months) presented to the neurology clinic at All Children’s Hospital for follow-up of his history of hypotonia and global development delay. According to the clinical note, he had been diagnosed previously with congenital hypotonia, and had developmental delays including expressive speech delays. It was further documented that Jeffrey has a history of abnormal signal intensities on brain MRI. The clinical note described Jeffrey’s developmental delays as follows: Parents relate today that he is making steady for developmental progress, although slowly. Parents are very involved with a home regimen of multiple therapies which they engage in with him on a daily basis. Presently, he is able to walk independently. He continues to be unsteady and falls frequently. He is not able to stoop to pick up an object and then stand back up alone without holding onto something. He is not yet running. He can pick up a Cheerio or small object with a pincer grasp: not able to yet hold onto a crayon and scribble. Expressive language reveals approximately 15-20 independent words, although these are inconsistent. He knows (approximately) 8 signs and uses these appropriately. He is not able to identify pictures in books; does not know body parts. He waves “bye bye” and initiates some activities. He is not potty trained. He wears glasses and does vision therapy. Developmental level at this time by Denver Developmental Assessment is gross motor: (approximately) 15 mo.; fine motor/adaptive: (approximately) 10 mo.; language: (approximately) 15 mo.; personal/social: (approximately) 15 mo. The All Children’s clinical note again documented Jeffrey as having congenital hypotonia and concluded that he is globally delayed, but making slow gains with “a lot of intervention/therapy.” As indicated in the preceding paragraphs, Petitioners have commendably sought advice, treatment, and evaluations from multiple health care providers and specialists in an effort to care for Jeffrey. At the time of Mrs. D’Angelo’s deposition on September 17, 2018, Jeffrey was four years, seven months old. Mrs. D’Angelo credibly testified about a “day in the life” of Jeffrey, his development, and his limitations. Jeffrey is currently receiving multiple therapies on a daily basis at Petitioners’ home. Mrs. D’Angelo credibly testified that Jeffrey receives physical therapy once per week, occupational therapy twice per week, speech therapy three times per week, music therapy twice per week, and Applied Behavioral Analysis therapy for 40 hours per week. His various therapies essentially begin at 8:00 a.m., and continue throughout the day until 5:00 p.m. Mrs. D’Angelo explained that, in physical therapy, the primary goal at this time is for Jeffrey to be able to transition stairs. Over the last 4.5 years of physical therapy, there has been some slight improvement in that 1) he no longer has to wear a medical helmet; 2) he no longer has a walker; 3) his leg braces were previously from the knee down and now they are only ankle braces; 4) and he can walk independently indoors with adult supervision with mats on the floor to protect him from falls. At this time, he does not walk independently without the mats due to the potential fall risk. Concerning his occupational therapy goals, Mrs. D’Angelo credibly testified that they are working on his prewriting skills. The team is working on his ability to draw a line. At present, he does not have the ability to independently hold a pencil or a crayon correctly. Mrs. D’Angelo explained that he continues to require speech therapy, as he is functioning at a one-year-old level. Although Jeffrey may be able to say 20-25 words, they are approximations. Essentially, he can say “mom,” “dad,” and “hi” clearly. Mrs. D’Angelo further credibly testified concerning other limitations. Jeffrey wears diapers and is not potty- trained. He can follow very limited one-task directions, but rarely two-step directions. Jeffrey cannot and does not play with other children. While he can use a “sippy cup,” he cannot use an open cup to drink and cannot use utensils to feed himself. In April 2018, Jeffrey was diagnosed with an undisputedly rare genetic disorder referred to as CHAMP 1. The undersigned finds that there was insufficient evidence presented by the parties concerning this disorder to make any findings as to whether Jeffrey’s impairments are caused by genetic or congenital abnormality. NICA retained Donald C. Willis, M.D., an obstetrician specializing in maternal-fetal medicine, to review the medical records of Jeffrey and Mrs. D’Angelo, and opine as to whether there was an injury to his brain or spinal cord that occurred in the course of labor, delivery, or resuscitation in the immediate postdelivery period due to oxygen deprivation or mechanical injury. Dr. Willis made the following findings and expressed the following opinions in a report, dated March 27, 2017: I have reviewed [the] medical records for the above individual. The mother, Katis D’Angelo was a 25 year old G1 with a history of successful treatment for preterm labor at 32 weeks. Prenatal course was otherwise without complications. The Mother was admitted at 37 weeks gestational age with spontaneous rupture of the membranes. Her cervix was dilated 1 cm. She was not in labor. Pitocin induction of labor was initiated for rupture of membranes. The fetal heart rate (FHR) monitor tracing was reviewed. There was no fetal distress. Cesarean section was done for failure to progress. Birth weight was 3,575 grams (7 lbs 14 oz’s). Extraction of the fetal head during Cesarean section was described as difficult. Several loops of umbilical cord were around the body of the fetus. Apgar scores were 2/6/8. Positive pressure ventilation was given for 5 minutes and chest compressions for 30 seconds. The baby was taken to the NICU for evaluation and management. NICU evaluation noted overall reduced motor activity and a rapid respiratory rate. X-ray showed bilateral vascular markings, compatible with transient tachypnea vs pneumonia. Several episodes of apnea occurred. Capillary blood gas at 5 hours of age was normal with a pH of 7.36. Antibiotics were started and continued for 7 days. Blood cultures were negative. Initial platelet count was low at 84,000. A short tongue frenulum, Ankyloglossia was present. This birth defect was later surgical[ly] corrected. Orogastric tube feedings were required for poor feeding coordination. Frequent body arching and posturing episodes developed. EEG on DOL 2 was normal. Head ultrasound was also normal. The baby was transferred to All Children’s Hospital due to possible seizure activity and poor feeding. Genetic testing, including microarray studies were negative. The child continue[d] to have hypotonia after hospital discharge. Neurology evaluation for hypotonia and motor developmental delay was done with the impression of a “complex medico-neurological condition of severe complexity.” EEG at about one year of age was normal. Sleep studies suggested upper airway obstruction. MRI found mild cervical spine narrowing, but no brain injury. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain or spinal cord that resulted in injury during labor, delivery and the immediate post delivery period. Dr. Willis’s findings and opinions were confirmed and verified in an affidavit dated September 1, 2017. At his deposition, Dr. Willis testified, in pertinent part, as follows: Q. Okay. What is your opinion as to whether or not Jeffrey D’Angelo suffered a birth-related neurological injury? A. I do not believe that there was any apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery, or the immediate post-delivery period. * * * Q. Would you briefly summarize your findings and basis for your opinion? A. Yes. Q. And refer to the report if necessary. A. Yeah. The mother was admitted to the hospital at 37 weeks gestational age with spontaneous rupture of the membranes. Labor was induced. She progressed to about 5 centimeters dilation and then had failure to dilate after that point. Cesarean section was then done for failure to dilate. And the – let me back up a moment. I did see the fetal heart rate tracings. And there was a nice set of fetal heart rate tracings during labor. I reviewed those. The fetal heart rate tracing did not show anything to me that suggested fetal distress during labor. It appeared to be a reassuring fetal heart rate pattern. Delivery was done by Cesarean section. Delivery was stated to be complicated or difficult because the umbilical cord was around the baby’s body. And the – and the delivery was stated to be difficult. When the baby was born, it was depressed. Apgar scores were 2 at 1 minute, 6 at 5 minutes, and 8 at 10 minutes. The baby did require positive-pressure ventilation for approximately 5 minutes. And chest compressions were approximately 30 seconds. The baby was taken to the neonatal intensive care unit. Chest x-ray showed – had some bilateral vascular markings which were compatible with transient tachypnea of the newborn. Shortly after birth the baby had some episodes of apnea. A capillary blood gas was done about 5 hours after birth, and it was normal. The pH was 7.36. EEG was done on day of life two, which was normal. Head ultrasound was also normal. The baby was transferred to All Children’s Hospital because – from what I gather from the records because they wanted to do an MRI. The MRI was done about two weeks after birth and was – and was normal. With respect to Jeffrey’s Apgar scores, Dr. Willis testified, in relevant part, as follows: Q. What did those Apgar scores mean or indicate to you in the context of your review of this case? A. Right. Well, usually we say that the one Apgar – the 1-minute Apgar score tells you what resuscitation is required. So Apgar score of 2 would be a low Apgar score. And that would mean that some resuscitation would be required after birth. The 5-minute Apgar score tells you a little bit more about what the baby’s acid base status, oxygen deprivation status would be. And that was 6. We consider the Apgar to be low if it is below 7. So the 5-minute Apgar was slightly lower than expected. By 10 minutes it was 8. So that would be within normal limits’ score for an Apgar. With respect to the diagnostic studies performed during the newborn period, Dr. Willis testified, in relevant part, as follows: Q. What is the purpose of an EEG? A. Purpose of the EEG is to determine if there’s any electrical brain injury. Q. Okay, and that’s a diagnostic study to determine if the brain is functioning properly? A. Correct. Q. And in this case on the second day of life an EEG was done and it was read as normal? A. Correct. Q. If J.D. in this case had suffered oxygen deprivation significant enough to cause brain damage in the course of labor and delivery, would you expect an EEG on day of life two to be normal? A. No. You would expect some abnormalities in that EEG. Q. So this EEG, correct me if I am wrong, would be inconsistent with . . . J.D. having suffered oxygen deprivation significant enough to cause brain injury at the time of labor and delivery in this case? A. Correct. * * * Q. And then you mentioned that an MRI was done at approximately 2 weeks of age? A. Correct. Q. And are you referring to the MRI that was dated March 6, 2014? A. Correct. Q. And what did that MRI reflect? A. That MRI was read as normal. So nothing on that MRI that suggested hypoxic or ischemic brain injury. And I felt that was very important in my – in my final disposition of this case because the delivery was somewhat difficult. And the baby was depressed at birth and required resuscitation. So that made me somewhat concerned about oxygen deprivation at birth. However, if the baby has oxygen deprivation at birth enough to cause brain injury, then the EEG will be abnormal and for sure the MRI at two weeks is going to show abnormalities. With a normal MRI at two weeks after birth, it really confirms that there was no oxygen deprivation during labor or delivery or the immediate post delivery period that was substantial enough to cause identifiable brain injury. Q. Okay. Is it fair to say, just to follow up on that MRI at two weeks, that the findings on that MRI are inconsistent with J.D. in this case having suffered oxygen deprivation significant enough to cause brain injury at the time of labor and delivery? Q. Correct. Dr. Willis’s findings and opinion that there was not a brain injury caused by oxygen deprivation or mechanical injury in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital are credited. NICA also retained Laufey Y. Sigurdardottir, M.D., a pediatric neurologist, to review Jeffrey’s medical records, conduct an independent medical examination (IME), and opine as to whether he suffers from a permanent and substantial mental and physical impairment as a result of a birth-related neurological injury. Dr. Sigurdardottir reviewed Jeffrey’s medical records and performed an IME on March 29, 2017. Dr. Sigurdardottir made the following findings and summarized her evaluation as follows: Pregnancy and Birth Summary: Jeffrey was born at 37 weeks 3 days to a 25-year-old G1, P0 serology negative mother after normal, noncomplicated, pregnancy. She did have premature labor at 32 weeks that resolved and then spontaneous rupture of membranes at 11 p.m. on 02/22/2014. Jeffrey’s mother presented shortly before midnight to Bayfront Health Labor and Delivery Ward, was found to have 1 cm cervical dilation and was admitted. She was not felt to be in active labor at that time. Labor was augmented with Pitocin but an emergent C-section was performed at 1 p.m. on 02/23/2014 due to failure to progress and arrested of fetal head. Fetal heart rate strips are available for our review and no fetal heart decelerations are noted. During the Cesarean section, the infant was found to be in a ROT position and large for gestational age. The extraction was difficult. The umbilical cord was noted to be wrapped around the legs with several loops and also around the abdomen. The infant was depressed at birth with Apgars of 2, 6 and 8 at 1,5 and 10 minutes. The infant was delivered at 1352 on 02/23/2014 weighing 3570g, length 51 cm and head circumference of 33cm. The infant did receive chest compressions for 30 seconds and positive pressure ventilation. Infant was noted to have respiratory distress and was admitted to Bayfront NICU for further evaluation. Infant had initial exam on admission suggestive of perinatal depression. His neurologic examination on admission revealed decreased muscle tone, decreased motor activity, symmetric Moro reflex, response to stimuli and no tremor. The infant had recovery of neurologic status apart from continued hypotonia and difficulty feeding. Infant was worked up with labs including a capillary blood gas at 5 hours of life showing a pH of 7.36 and a base excess of - 0.6. PCo2 was 48. Initial creatinine measurement was 1 and had a steady decline after that. AST and ALT were found to be normal. Initial platelets were found to be 84,000 with recovery to 165,000 by 6 a.m. on 02/24/201[4]. EEG performed on day of life 2 was found to be normal with no indication of a lowered seizure threshold and no abnormality on background activity. Head ultrasound was also performed and found to be normal. Infant had transient tachypnea, tongue ankyloglossia, possible sepsis and was treated with antibiotics. Nutritional status was found to include initial low blood glucose and episodes of arching with feeding. The patient did require partial gavage feeding prior to discharge. Discharge was on 03/05/201[4]. Developmental and Medical History: Jeffrey continued to exhibit delays in neurologic development. Per parents’ report, he had poor feeding abilities, was found to have low muscle tone and required therapies, occupational, physical, and speech therapy, from a very early age. He sat around 14 months, crawled at 15 months and walked unassisted at 22 months. He has had significant language delays, although at this time he has 20-25 words. He has been found to have apraxia of speech. The patient has had ophthalmologic abnormality including a downward eye deviation that the parents report and was seen at Boston Children’s Hospital at the age of 9 months for a second opinion of the underlying etiology for his delays. He has had genetic workup including microarray and Prader-Willi has also been ruled out. Patient has had multiple neuro radiologic evaluations of brain and spinal cord. The initial MRI was performed on 03/06/2014 and found to have a brain that seems normal in signal intensity including gray and white matter on multiple sequences. Vascular structures appear grossly normal. The second evaluation is a brain ultrasound on 07/29/2014 which shows mild increased CSF fluid spaces. A second MRI was performed in September 2014 and showed increased bifrontal temporal extraaxial convexity, effusion and mild ventricular dilation as compared to study from 03/06/2014. This was considered to be suggestive of a communicating hydrocephaly with impaired drainage at the level of the arachnoid granulations. An MRI of the cervical spine was also performed and showed mild C3-C5 spinal canal stenosis. A follow up MRI was then performed on 01/26/2015 with no interval change in the spinal stenosis at C3-C5 and no significant change in appearance of the extraaxial fluid or ventricular size. A 3rd follow up MRI then performed in May 2015 which showed possible increased in kyphosis of cervical region but no clear change in ventricular size and possible decrease in amount of extraaxial CSF spaces. Final MRI was then performed on July 2016 which continues to show mild bilateral and lateral ventricular dilation and bifrontal temporal convexity, extraaxial fluid. This was deemed to be stable. In the final MRI there are noted small foci of bifrontal white matter increased FLAIR signal without associated mass effect. Jeffrey has been treated with vigorous therapy, both with therapy providers as well as with his parents and has undergone hyperbaric oxygen therapy. Parents feel that he continues to be significantly delayed as compared to his peers. But now he is more responsive to them. He has been evaluated for possible autism and found to be negative for such symptoms on 3 occasions, as per parents’ report. * * * Physical Examination: Jeffrey is 17.7 kg, 91.4 cm and his head circumference is 51 cm. This places his growth parameters to be at the 95th percentile for weight, at the 13th percentile for length and his head circumference to be at the 59th percentile. His general exam is as follows: Head and Neck: There are no obvious dysmorphic features, although mouth tends to be open. He does have conjugate eye movement. Lungs: Clear to auscultation. Cardiovascular exam reveals first and second heart tones, no noted heart murmurs, no rhythm abnormalities. Abdomen is soft, no hepatosplenomegaly. GU normal. Musculoskeletal: He does have some increased joint laxity. Skin is without abnormal markings. Neurologic Examination: Mental status: The patient is interactive with his parents often needing multiple requests to comply with their requests for him. He does wave bye-bye. He does clap and does have occasional words that are difficult for this examiner to understand. His eye contact seems at times to be poor. No repetitive behavior is noted. Cranial nerves: His pupils are equal, reactive to light. He has full visual fields. Extraocular movements are conjugate. His facial expression is somewhat diminished. His hearing seems intact to voice. Motor exam reveals generalized hypotonia with some increased joint laxity, but full strength. Reflexes are difficult to elicit but present. Balance and coordination is delayed for age, although fine motor skills assessment is not performed. Summary: Jeffrey is a 3-year 1-month-old boy with motor and speech delays from birth. There is documented fetal depression but no clear documented fetal heart rate disturbance after the onset of active labor. His current status is improved from early in life and he is now able to ambulate without support and has started speaking in single words. There are no signs of autistic features. Result as to question 1: Jeffrey is not found to have a substantial physical impairment at this time. He is found to have a substantial language impairment at this time. Result as to question 2: In review of available documents, although having neurologic depression requiring some resuscitation at birth, there is no clear acute hypoxic event, and fetal heart rate strips were relatively benign. MRI performed in the neonatal period, EEG performed in the neonatal period did not support an acute encephalopathy. No laboratory evidence of multisystem hypoxic changes were noted in postnatal period. Result as to question 3: The prognosis for full motor and mental recovery is guarded but his life expectancy is full. Due to absence of evidence of hypoxic event during active labor, absence of secondary findings supportive of a hypoxic encephalopathy (MRI, laboratory or EEG) and his ongoing motor and cognitive progress, I do not feel that he should be included in the NICA program. (JE I, P. 1-3). Dr. Sigurdardottir confirmed and verified her opinions in an affidavit dated August 31, 2017. Dr. Sigurdardottir also testified, in relevant part, during her deposition on February 14, 2018, as follows: Q. And what were your conclusions to those questions (asked by NICA)? A. The conclusions are the following: Jeffrey is not found to have a substantial physical impairment at this time. He is found to have a substantial language impairment at this time. That is question one. So question one, he does not fulfill the criteria having both a substantial physical impairment and mental impairment. Result of the question two, that although having neurologic depression requiring some resuscitation at birth there is no clear precipitating acute hypoxic event that we can establish with the available records that we have, including fetal heart restrict, as well as in the neonatal post natal period there was no evidence of multi- system organ failure that often goes along with hypoxic ischemic events. So there was an MRI performed within the first two weeks, an EEG that was performed in a neonatal period, and then no laboratory evidence of multisystem hypoxic injury. On cross examination by Mr. D’Angelo, Dr. Sigurdardottir further explained her opinions and analysis as follows: Q. So what do you personally think was just the resuscitation he needed at birth likely? And I understand we’re not dealing in terms of absolutes, but was the likely cause of my son’s injury due to low amounts of oxygen at birth? A. Well, I would say it’s clear he had neurologic depression at birth. Then, we start looking for signs that would indicate that that would happen, such as the fetal heart rate [t]racing, that was benign. There was nothing in that that indicated there was lack of oxygen. And then after birth, even though he had neurologic depression, we did not have any of the hard evidence that he had significant hypoxic ischemic encephalopathy, is what we call it, and that’s when you have other systems involved, like the liver test becomes abnormal, the creatine continues to rise, his active base balance at the age of five hours looked fairly good, did not show a metabolic acidosis. And then an MRI that was performed, I believe, on day of life 10 or 11, that did not show any abnormality at that point that indicated an acute ischemic injury. So we have little that supports it from all of the laboratory results that we have and the fetal heart rate [tracing]. Dr. Sigurdardottir’s findings and opinion that Jeffrey has a substantial language impairment is undisputed and credited. Her opinion that Jeffrey does not have a substantial physical impairment is not credited for the reasons discussed below in the Conclusions of Law. Dr. Sigurdardottir’s opinion that there is evidence of fetal depression, but insignificant evidence (at birth) to establish significant hypoxic ischemic encephalopathy is supported by the evidence and is credited. Petitioners submitted a notarized statement from Jeffrey Huber in support of their position that Jeffrey sustained a birth-related neurological injury. It appears that Mr. Huber was the respiratory therapist in the operating room at the time of delivery. Mr. Huber’s statement provides, inter alia, that Jeffrey had a “lack of ventilation for longer than 2 minutes.” Although Mr. Huber’s statement has been considered, it constitutes hearsay and cannot support independently any finding of fact. Additionally, Dr. Willis and Dr. Sigurdardottir, the only qualified medical experts who have testified in this matter, both represented that Mr. Huber’s statement was duly considered by them and did not change any of their opinions and ultimate conclusions. Specifically, Dr. Willis testified, in relevant part, as follows: Q. Did that report [and] statement from Mr. [H]uber have any impact on your ultimate opinions and conclusions? A. No. No, it did not. Most of the things that he – that he talked about in there were part of the medical records. The fact that the baby required resuscitation, required chest compressions was all in the medical records. So nothing new there. He does not state exactly what his position is, but I assume from what I’ve read he must be somehow involved with respiratory therapy. So nothing new as far as what was in the medical records in his report.
Findings Of Fact Introduction At all times relevant hereto, respondent, Albert Sneij, was a licensed physician having been issued license number ME0034499 by petitioner, Department of professional Regulation, Board of Medicine (Department or Board). Most recently, respondent maintained a practice of family medicine at 460 Washington Avenue, Miami Beach, Florida. Respondent, who is 42 years old, is a native of Syria where he received his medical degree from a Syrian university in 1971. His medical training consisted of a seven year curriculum taken immediately after high school. After graduation from medical school, Dr. Sneij worked a short time in Syria and Lebanon and then immigrated to the United States in June 1972. He worked first as an intern at a hospital in St. Louis, Missouri. After performing a residency in surgery at an Albany, New York hospital and working for a time in an emergency room, Dr. Sneij secured his Florida license in 1979. In 1980, he permanently relocated to the Miami area where he began a family practice. Besides having a Florida license, respondent also holds licenses to practice in New York and California. He has hospital privileges at South Shore Hospital in Miami Beach, but that institution has no obstetrical wing. This case centers around the actions of respondent while delivering the baby of Marlene Alonso in November 1987 and whether such actions conformed to the level of skill, care and treatment expected of a physician in the Miami area. The delivery, which took place after a lengthy period of labor, occurred in a tub of hot water. This procedure is known as underwater birthing. After the baby died, Alonso filed a complaint with the Department. This led to the issuance of an administrative complaint on February 1, 1988. The complaint charged Dr. Sneij with gross malpractice or with failing to treat the mother and baby 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 (Count I), accepting and performing a responsibility for which he was not competent (Count II), inappropriately administering a legend drug (pitocin) not in the course of his professional practice (Count III), failing to obtain Alonso's full, informed written consent to the underwater birthing procedure even though this procedure was experimental (Count IV), and failing to keep written medical records justifying the course of treatment (Count V). The complaint prompted respondent to request a hearing. Underwater Birthing At issue in this proceeding is the so-called underwater birthing procedure used by respondent. It is sometimes referred to as the "Leboyer approach to delivery." Under this procedure, the expectant mother is placed in a tub of hot water at the onset of labor. The baby is eventually delivered underwater in the hot tub. The intended beneficial effect of this procedure is to cause less tension or trauma for the baby since, according to proponents, the baby lives in a "water" environment in the mother's womb, and a delivery into the hot water will be a continuation of the uterine existence. Since the baby still breathes from the umbilical cord, there is supposedly no danger in the baby being underwater for the first few moments of birth. The method is intended to be more relaxful to a mother since the water has a calming effect on the patient and obviates the need for analgesics. There is no recognized, published medical literature on the subject of underwater birthing. However, respondent introduced into evidence three textbooks on the subject for the purpose of showing that such literature existed. None were written by medical doctors from the United States. Underwater birthing originated in Russia in the late 1970's and has been performed in France and perhaps a few other European countries. In this country, several successful underwater births have been performed recently in the State of California. One Board expert characterized the procedure as experimental sinxe there is no scientific evidence to support the claim that the procedure can be safely used. A second Board expert said it was not experimental since it had "been around" for awhile and is now being used "in some (birthing) centers" and in Europe. However, it is not a generally accepted procedure by the medical community in South Florida since, with the exception of respondent, no other area physician uses this form of delivery. Required Procedures During Childbirth In at least 85% of all deliveries, the baby is delivered head first. However, if the legs and buttocks come out first, the birthing is considered a breech delivery. Whether a delivery is normal or breech is a matter of extreme importance since a breech delivery poses more risks to the baby and mother and is more prone to complications. For this reason, the prudent physician always determines the position of the baby prior to delivery. To do this, a physician typically conducts an abdominal and pelvic examination of the patient. If the physician still has any doubt as to the baby's position, an ultrasound may be used. This is a noninvasive sound wave sonar picture which can determine the baby's position with absolute accuracy. If the physician has no ultrasound in his office, the patient should be taken to a facility where such a machine is available. Once the physician determines that a baby is in a breech position, he should recognize immediately the possibility that the mother will have a problem with the descent of the baby and that certain steps should be taken to minimize any risk to the baby and mother. At the same time, the patient should be informed that the baby is in a breech position and certain risks are present and she should have explained the options that are available to her. Most importantly, the patient should be transferred to a hospital setting where surgery can be performed, if necessary, to remove the baby. If a mother is experiencing her first delivery, the baby is at greater risk because the pelvis has not been tested and the pelvic tissues are more resistant to the passage of the baby through the pelvis. Therefore, if a breech delivery is recognized and the patient is in her first pregnancy, the prudent physician should recognize the greater degree of risk and place the mother in a facility where surgical capabilities are available. In some deliveries, the drug pitocin is used to increase the mother's contractions and bring on delivery. Good medical practice dictates that it should never be administered intramuscularly before delivery since the doctor loses control over the effects of the drug once the drug is injected. Indeed, such a practice is considered "a dangerous approach" to the use of the drug since it can cause the uterus to remain contracted in tetanic form thereby cutting off circulation to the placenta. Instead, the drug should be given intravenously to allow the doctor to control the amount given to the patient and to monitor her reactions. Generally, the drug is given in very small increments and gradually increased to achieve the desired uterus contractions. At the same time, the baby's fetal heart rate should be monitored continually by the doctor to verify that the heart rate is not being affected by the strength of the contractions. This can be done by stethoscope or fetal heart machine, either of which is appropriate. It was agreed that the attending physician is the best person to determine when to use the drug. In a normal, uncomplicated breech delivery, the head is usually delivered within five minutes after the actual delivery begins and "almost immediately" after the trunk delivers. If the head does not deliver promptly, steps should be taken by the physician to aid in the delivery of the head by using one's hands or forceps. If a greater than normal time elapses between the delivery of the head and trunk in a breech delivery, the baby runs the risk of being deprived of oxygen, thereby causing brain damage or even death. This is because the umbilical cord may become compressed against the pelvic inlet as the head is coming through the pelvis. Indeed, one expert opined that such compression would occur "in all cases". To determine if compression is occurring, a doctor should monitor the pulsation of the cord and the fetal heart rate. A pulsating cord means the baby is receiving oxygenated blood. In a breech delivery, the patient's head must be kept flexed in a certain direction to facilitate delivery. Further, a physician has more difficulty in performing the manipulations required if complications arise. These difficulties are exacerbated if the delivery occurs in water. If a baby is "limp" after breech delivery and has a low Apgar score, it is standard procedure for the physician to immediately institute resuscitative measures. This is done by first clearing the airway, administering oxygen and then supporting the baby by artificial ventilation. This latter step is accomplished generally by clearing the airway and giving oxygen under pressure. The standard practice in the Miami area is to deliver large babies by Cesarean section if a breech position is noted. However, not all breech babies are delivered surgically. The Actual Incident Marlene Alonso, then twenty-three years of age, became aware of respondent in early 1987 after reading respondent's advertisement concerning the water birthing procedure. The advertisement appeared in a magazine sold at a local health food store. She was then two months into her first pregnancy. After making an appointment, Alonso met with Dr. Sneij, viewed several tapes of water birthing deliveries and had a "consultation". At the first meeting, respondent told Alonso that the procedure was developed in Eastern Europe and was "common" over there, that this method of delivery was "less stressful" for both mother and baby, and that it was less risky than other forms of childbirth. He did not require Alonso to sign a consent form. Alonso chose respondent as her physician because she had no insurance and insufficient funds to have a hospital birth. Also, she was satisfied the procedure was safe even though she knew respondent was the only doctor in Florida using this procedure. Her satisfaction was based upon respondent's representations and reinforced by her husband's cursory research on the subject which included reading a newspaper article at a local library concerning such deliveries being performed by midwives in California. The Alonsos did not consult any other physicians about the procedure. Alonso visited respondent once a month for the first few months, then biweekly and finally once a week in the final stages of her pregnancy. During her visits, Alonso sometimes asked if the baby was positioned head first and Dr. Sneij always responded that everything was "fine." Indeed, after several visits, Dr. Sneij noted in his medical records that the baby was "head down." Respondent has a small office on South Beach in Miami Beach consisting of several rooms. The largest room measured around 12' x 16' and had a hot tub used for underwater birthing. Doctor Sneij used this room for his deliveries. Although the room had shelves on which medicine was stored, no medical equipment, such as oxygen or operable monitoring equipment, was maintained on the premises. When the events herein occurred, two secretaries worked at the office. Alonso's onset of labor began on the evening of Sunday, November 1, 1987. She arrived at respondent's office around 11:00 p.m. that evening with her husband. After respondent gave her an enema, she was placed in a hot tub where she remained for most of the night. As was customary with respondent's office birthings, he taped a part of the birthing with a video camera placed near the tub. A copy of the video tape has been received in evidence as petitioner's exhibit 1. Present during all or part of the delivery were Alonso's husband, her parents, sister-in-law, Dr. Sneij, his wife (who he said acted as his assistant) and two young children, a secretary and a friend who taped part of the delivery. During the first twenty-four hours, Alonso received one injection of demoral for pain and was given occasional sips of honey water. She and the fetus were periodically checked by respondent with a stethoscope during this time. At around the twenty-hour point, Dr. Sneij advised Alonso the baby "might be" in a breech position. However, he confirmed this in a conversation with Alonso's mother-in-law, and his medical notes recorded earlier that day reflected that the "fetus was in breach (sic) presentation." Respondent then advised Alonso that she should be transported to a hospital for a "C-Section". Although respondent had no hospital privileges, and Alonso no insurance, he nonetheless attempted to get Alonso placed in a local hospital. When he met with no success, respondent returned and told everyone he was waiting for a doctor at Jackson Memorial Hospital to return a call. After examining Alonso's abdomen with a stethoscope, Dr. Sneij remarked that the baby had a "strong heartbeat," that by a "miracle" its head was "down" and not in a breech position, and that hospitalization would not be required. He then "guaranteed" Alonso would have no problems. This occurred around the twenty-four hour mark. At one point, Alonso requested that respondent hook up his fetal heart rate monitor to her but respondent said he was out of paper. Alonso desired the paper printout as a souvenir for her baby. To hasten the delivery, and in response to Alonso's pleas to do something, respondent injected pitocin intramuscularly into Alonso on three occasions, the first time around 10:00 p.m. on November 2. According to respondent's medical notes, the first dosage contained "3 units". At midnight, respondent gave a second injection containing "3.5 mg." of pitocin. Two hours later, Alonso received a third injection containing 3.5 units of the drug. Alonso's delivery began around ninety minutes later. When the actual delivery began around 3:30 a.m. on November 3, or after thirty-three hours of labor, Alonso was half standing and leaning over in the tub of water. Dr. Sneij remarked that "the head is out." However, the legs and buttocks of the baby delivered first. From a kneeling position in the tub beneath Alonso, Dr. Sneij continued to manipulate the baby with his fingers in an effort to complete the delivery but the head did not pass out of the vaginal canal until some twenty-two minutes later. The baby, which weighed eight pounds twelve ounces and was considered "large", was held under water for a few moments and then placed on the mother's abdomen for a few seconds. All the time Dr. Sneij kept feeling the cord. After observing that the baby was purple and not moving, he took her back, wiped "stuff" out of the baby's mouth and began adminis-tering mouth-to-mouth resuscitation. At that point, Alonso called out for someone to telephone 911 for an emergency vehicle but respondent said "no." Even so, Alonso's father telephoned for an ambulance. When the 911 team arrived, one of the technicians immediately cut the umbilical cord. After respondent inserted an endotracheal tube in the baby's throat, and while he continued mouth-to-mouth resuscitation, the baby and mother were transported to Mount Sinai Hospital. The baby remained on a life support system for seventeen days until the system was turned off. It was brain dead during this entire period of time. The actual cause of death, as determined by autopsy, was dystocia, which, according to the medical examiner, meant a difficult childbirth caused by the head not getting out of the vaginal canal in a prompt, normal fashion. In his medical records, Dr. Sneij characterized the complication as "respiratory dysfunction, in otherwise normal baby" and that this complication "could be caused by an adverse drug action, or reaction most probably due to pitocin." However, he did not rule out "other factors that were not known to (him)." Adequacy of Medical Records Respondent's medical records relating to the incident have been received in evidence as petitioner's exhibit 2. Since there was no expert testimony concerning their adequacy in terms of justifying Dr. Sneij's course of treatment of the patient, the contents of the exhibit need not be repeated herein. E. Competency or Disaster? Testifying on behalf of the Board were three physicians. They included Dr. Nathan B. Hirsch, a Coral Gables obstetrician and gynecologist since 1971 and one-time professor at the University of Miami Medical school, Dr. Allan G. W. McCleod, an obstetrician and gynecologist who has taught that subject at the same medical school since 1960, and Dr. Roger Mittleman, an associate medical examiner for Dade County and board certified in forensic pathology and anatomical and clinical pathology. Respondent, who is a licensel medical doctor, testified on his own behalf. As might be expected, petitioner's witnesses and respondent reached sharply conflicting conclusions regarding respondent's skill and competency while treating Alonso. However, no expert ventured an opinion as to respondent's competency outside the area of obstetrics or whether respondent was incompetent to initially accept Alonso as a patient to provide prenatal care and assist in the delivery. Appropriate findings regarding this testimony will be made below. As a starting point, Dr. Hirsch viewed petitioner's exhibit 1 in its entirety. That exhibit is a video tape of part of Alonso's delivery. Characterizing the tape as an "outrageous, horror movie," Dr. Hirsch concluded that Dr. Sneij's conduct constituted a "dramatic deviation from the standard of care in (not only the Miami) community," but "any community in the world." Doctor Hirsch noted first that Alonso's labor lasted around thirty-three hours which was "excessive" by any standards. The expert pointed out that Dr. Sneij deviated from generally accepted practice by injecting pitocin intramuscularly into Alonso on three occasions in amounts of one hundred and one hundred and fifty milligrams. This was contrary to the accepted practice of administering the drug intravenously in small increments so that the doctor can control the amount being given to the Also, Dr. Hirsch did not observe respondent monitor the baby's heart rate after the injections. Doctor Hirsch noted also that even though respondent recognized the baby in a breech position some six to eight hours after the onset of labor, and knew this was Alonso's first pregnancy, he continued the delivery process in an office setting. According to the expert, a prudent physician would have recognized the risks of this setting and transferred the patient to a high-risk obstetrical center with the capability of performing surgery if needed. By respondent failing to do so, Dr. Hirsch concluded Dr. Sneij's actions constituted a deviation from the standard of care. Doctor Hirsch did not observe any visible evidence of "sterile technique" in respondent's office. Further, Dr. Hirsch opined that respondent should have had, at a minimum, electronic monitoring equipment and the necessary equipment to perform emergency surgery if the need arose. At the time of delivery, as depicted on the tape, the expert observed the delivery of the legs and buttocks to the baby's umbilicus. He saw then the bottom portion of the baby hanging from the vagina with respondent's hands on the buttocks and legs for some twenty-two minutes until the upper half delivered. According to Dr. Hirsch, this time frame was of dramatic medical significance since, in a breech delivery where the baby is delivered to the umbilicus, the baby must be out of the canal within one minute or suffocate. The witness concluded the baby was dead within five to eight minutes after the lower half delivered. Doctor Hirsch opined also that during the lengthy delivery, respondent did not appear to understand or use proper delivery techniques that would have hastened the delivery. However, he did not elaborate on what specific techniques should have been used. After the baby was delivered, Dr. Hirsch concluded that respondent erred by holding the baby underwater for about two minutes. According to the expert, respondent should have taken the baby to a nearby delivery table and attempted to resuscitate the baby. Also testifying for the Board was Dr. Allan Gordon Walker McCleod, an obstetrician/gynecologist and a member of the faculty at the University of Miami Medical School since 1960. As did Dr. Hirsch, the expert viewed petitioner's exhibit 1, which is the tape of the delivery. Doctor McCleod concluded that respondent did not meet the community standards of care when he failed to accurately determine the presentation of the baby at the outset of labor. He pointed out further that, during the delivery itself, he saw no evidence of Dr. Sneij monitoring the baby's fetal heart rate or the pulsation of the cord. According to Dr. McCleod, both steps should have been taken here, particularly in light of the lengthy time (22 minutes) between the delivery of the trunk and the head. The expert also criticized respondent's efforts to perform a breech delivery in a hot tub. This was because the patient was in a sitting position on the slide of the tub making it difficult for the doctor to perform the required manipulations. Further, the tub made it difficult for respondent to adequately monitor the baby during the delivery. Doctor McCleod criticized next the administering of pitocin to Alonso prior to delivery as being contrary to the standard of care. He noted that such a practice is not used in "present-day obstetrics", is "dangerous" to the patient and baby, and that such risks should be "common knowledge" to all physicians. He observed finally that after administering the pitocin, respondent did not record the length of contractions or fetal heart rate to determine the patient's response to the drug. The expert concluded that Dr. Sneij acted improperly by keeping the baby underwater "for a long period of time" once it delivered even though it was "very limp", "hypoxic" and had very little muscle tone. Even after it was removed from the water and placed on the mother's abdomen, Dr. McCleod noted that respondent still made no effort to resuscitate the baby. When respondent finally instituted resuscitative measures, Dr. McCleod observed no effort by respondent to clear the airway or to use mechanical ventilation. In summary, Dr. McCleod concluded respondent was negligent by giving a lack of prenatal care, by failing to timely recognize an abnormal presentation, by failing to properly handle labor, by inappropriately administering a legend drug, and by failing to make proper efforts to resuscitate the infant. He recommended that respondent not be allowed to practice obstetrics until Dr. Sneij received further training in that area. The final Board expert was Dr. Roger Mittleman, an associate medical examiner for Dade County who has performed over 3,300 autopsies in his career. Doctor Mittleman performed an autopsy on the Alonso baby and concluded that the cause of death was dystocia brought about by the head not getting out of the vaginal canal in a timely manner. According to Dr. Mittleman, the baby was born brain dead due to a lack of oxygen to the brain during the twenty-two minute delivery. Although the heart was still beating when the baby delivered, Dr. Mittleman said the baby was dead for all practical purposes. Respondent testified on his own behalf and generally denied all allegations. He had no opinion as to the cause of the baby's death and denied his actions contributed in any way. Respondent acknowledged he knew from the outset of labor that the baby was in an abnormal presentation but said this gave him no concern since the patient was young and healthy, and breech deliveries were not always complicated. Also, he had no concern over the length of labor (33 hours) since he had performed several other water births where labor consumed around ninty hours. As to the administering of pitocin intramuscularly, Dr. Sneij contended he recognized the risks of the drug but that he minimized any risk by injecting it in small doses. In addition, he denied that there was an inordinate length of time between the delivery of the trunk and the delivery of the head. In that vein, he opined that because Alonso had been in labor for a long time and had dilated well, the possibility of cord compression was "zero or near zero." Also, he pointed out that he repeatedly felt between the baby and the vagina and could not feel "severe pressure." According to respondent, the cord was of "good size" and was continually pulsating throughout the entire delivery. Respondent assumed the baby was merely "tired of birth" after it fully delivered, and for this reason, left her in the water "for about a minute." When he realized resuscitative measures were needed, which he says were due to "birth trauma," Dr. Sneij claims he did all he could for the baby and, by turning the baby upside down, he cleared the baby's airwave by force of gravity. Finally, if he were presented with the same case again, respondent said he would not do anything differently. Although respondent is not board certified in any specialty, he characterizes his experience as being "very wide." When he first came to the United States, his primary interest was in orthopedic surgery. He subsequently developed an interest in obstetrics, but stated he had no opportunity to engage in that type of practice until he delivered his own first child. In all, Dr. Sneij represented he has delivered some twenty-four babies during his career, including the last eight by underwater birthing. One of those eight was his own. After considering all of the testimony herein, the testimony of experts Hirsch, McCleod and Mittleman is accepted as being more credible and persuasive than that of respondent. Accordingly, it is found that respondent failed to conform with the statutory standard of care by failing to timely recognize the baby's presentation, by failing to timely send Alonso to a hospital setting, by improperly managing the labor, by inappropriately administering pitocin to the patient, by having inadequate equipment at his office, and by failing to promptly take steps to resuscitate the baby after delivery.
Recommendation Based on the foregoing finding of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty as charged in Counts I, II, and III and that all other charges be DISMISSED. It is further recommended that the penalty set forth in paragraph 49 of the conclusions of law be imposed. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 4th day of November, 1988. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 4th day of November, 1988. APPENDIX RESPONDENT: 1-3. Covered in finding of fact 14. 4-5. Covered in finding of fact 15. Covered in finding of fact 4. Covered in finding of fact 15. Covered in finding of fact 17. Covered in findings of fact 18 and 26. 10 Covered in finding of fact 36. Partially covered in finding of fact 7. The remainder is rejected as being contrary to the more credible and persuasive evidence. Partially covered in findings of fact 7 and 20. The last sentence is rejected since it is contrary to the more persuasive evidence that pitocin be given in small increments intravenously. Rejected as being irrelevant since the statute does not require that an actual injury to the patient occur by virtue of a physician's inappropriate conduct. Covered in finding of fact 9. Covered in findings of fact 18 and 21. Covered in finding of fact 9. Covered in finding of fact 21. Covered in finding of fact 10. Rejected as contrary to the more persuasive evidence that this was an abnormal delivery. Covered in finding of fact 21. Covered in finding of fact 36. Covered in findings of fact 21 and 36. Covered in finding of fact 22 except that while the heart was still beating, the baby was brain dead at delivery. Covered in finding of fact 38. Covered in finding of fact 34. Covered in finding of fact 24. COPIES FURNISHED: William O'Neil, Esquire 151 Crandon Boulevard, No. 125 Key Biscayne, Florida 33149 Harold M. Braxton, Esquire Suite 406 9100 South Dadeland Boulevard Miami, Florida 33156 Dorothy Faircloth, Executive Director Board of Medicine 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue Did Mary Moshier violate Section 464.21(1)(b) , Florida Statutes, as alleged in the Administrative Complaint?
Recommendation It is noted as a fact in mitigation that Moshier was suspended for 21 days by the hospital where she worked for the incidents that gave rise to this Administrative Complaint. Based upon the foregoing Findings of Fact and Conclusions of Law, and considering the facts in mitigation, the Hearing Officer recommends that Mary Moshier be placed on probation for a period of six months for the violation of Section 464.10(1)(f) , Florida Statutes, by using profane language regarding a patient in the vicinity of the patient. DONE and ORDERED this day of May, 1980, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1107 Blackstone Building 233 East Bay Street Jacksonville, Florida 32202 Joseph S. Farley, Jr., Esquire 350 East Adams Street Jacksonville, Florida 32202 Geraldine B. Johnson, R. N. Beard of Nursing 111 Coastline Drive East, Suite 504 Jacksonville, Florida 32202
Findings Of Fact Beckham was born on August 31, 2016, at St. Joseph’s located in Tampa, Florida. Based on the hospital records in evidence, Lindsay D. Hinson-Knipple, M.D., was the delivering physician for Beckham’s birth. Dr. Hinson-Knipple was a “participating physician” under the Plan at the time Beckham was born. See § 766.302(7), Fla. Stat. Upon receiving the Petition, NICA retained Donald Willis, M.D., an obstetrician/gynecologist specializing in maternal-fetal medicine, as well as Laufey Y. Sigurdardottir, M.D., a pediatric neurologist, to review Beckham’s medical records. NICA sought to obtain an opinion whether there was an injury to Beckham’s brain or spinal cord at birth caused by oxygen deprivation or mechanical injury occurred in the course of labor, delivery, or resuscitation in the immediate post-delivery period, and whether that injury rendered Beckham permanently and substantially mentally and physically impaired. Dr. Willis reviewed Beckham’s medical records and opined, within a reasonable degree of medical probability: here was no apparent obstetrical event that resulted in oxygen deprivation or mechanical trauma during labor, delivery and the immediate post-delivery period. Dr. Sigurdardottir also reviewed Beckham’s medical records, as well as examined Beckham on October 10, 2018. Dr. Sigurdardottir opined, within a reasonable degree of medical probability: hat Beckham does not have a substantial mental or physical impairment. In addition, although there is . . . MRI evidence of impairment consistent with a neurologic injury to the brain acquired due to oxygen deprivation or mechanical injury, the timing of this injury cannot be established to have occurred in the birthing process. A review of the file reveals no contrary evidence to dispute the findings and opinions of Dr. Willis and Dr. Sigurdardottir. Their opinions are credible and persuasive. Based on the opinions and conclusions of Dr. Willis and Dr. Sigurdardottir, NICA determined that Petitioners’ claim was not compensable. NICA subsequently filed the Unopposed Motion for Summary Final Order asserting that Beckham has not suffered a “birth-related neurological injury” as defined by section 766.302(2). Petitioners do not oppose NICA’s motion.
The Issue At issue is whether Natalie Taylor (Natalie), a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan (Plan).
The Issue The issue presented is whether Respondent is guilty of the allegations set forth in the Administrative Complaint, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0020248. Respondent is a board- certified pathologist who completed a residency in obstetrics and gynecology in Venezuela and practiced in the field of obstetrics and gynecology in South America for almost five years before coming to the United States. On April 20, 1991, patient J. B., a 27-year-old female, came to A Woman's Care, where Respondent was then employed, for the purpose of terminating her pregnancy. She indicated on a patient history form that the date of her last menstrual period was January 30, 199l. According to the medical records from A Woman's Care, she did not express any uncertainty or equivocation with respect to that date. One method of determining gestational age is based on calculating from the last menstrual period, assuming that the patient's history is reasonably reliable. With a history of a last menstrual period on January 30, 1991, the gestational age of the fetus on April 20, 1991, based upon a calculation by dates, was seven weeks. After obtaining a history from the patient with respect to the date of the last menstrual period, the physician needs to perform a bi-manual examination of the patient in order to assess the size of the uterus and to confirm the history given by the patient. Although the bi-manual examination is a reasonably reliable method of assessing the stage of pregnancy, it is a subjective examination and can sometimes be difficult. There is an acknowledged inaccuracy with respect to that clinical evaluation. The most accurate method of determining the gestational age of a fetus is through ultrasound examination. An ultrasound is performed when there is uncertainty as to the gestational age, such as when the patient does not know the date of her last menstrual period or when there is inconsistency between the patient's disclosed date and the physician's bi-manual examination. There is a general correlation between the size of the uterus in centimeters on bi-manual examination and gestational age in weeks. It is important to determine the gestational age of the fetus before performing a termination of pregnancy because the gestational age is the determining factor in deciding the size of the instruments to be used in the procedure and the amount of tissue to be removed. Respondent performed a bi-manual examination of the patient and recorded that his examination revealed a uterus consistent with an approximately seven-week gestation. Because the gestational age by dates and the results of the bi-manual examination both indicated a seven-week pregnancy and were consistent, Respondent did not order an ultrasound examination for the purpose of determining gestational age. On April 20, 1991, Respondent performed a termination of pregnancy on patient J. B. after the patient was informed of the possible risks of the procedure and after the patient signed a Patient Informed Consent Form. That Form detailed the possible risks, including infection and incomplete termination. Based upon the patient's history and the bi-manual examination and his conclusion that the patient was approximately seven-weeks pregnant, Respondent used an 8 mm Vacurette to terminate patient J. B.'s pregnancy. An 8 mm Vacurette is an appropriately-sized device to terminate a seven-week pregnancy. After completing the procedure, Respondent submitted the tissue obtained to a pathologist who determined that three grams of tissue had been submitted, consisting of products of conception and chorionic villi. The pathology report revealed what would reasonably be expected as a result of the termination of a seven-week pregnancy. After the procedure, the patient was given written instructions for her care and was discharged from A Woman's Care at 10:35 a.m. On April 21, 1991, at approximately 6:30 a.m., the patient's grandmother telephoned A Woman's Care to advise that the patient was complaining of dizziness and pain. The patient was advised to take Tylenol and call back if she continued to feel sick. At approximately 7:30 a.m., the patient's grandmother called again to advise that the patient was going to go to the hospital. On April 21, 1991, at 1:25 p.m., patient J. B. arrived at the Emergency Room at North Shore Medical Center with a temperature of 104.3 degrees, an elevated white blood cell count, chills, lower abdominal pain, and spotting. The patient was seen during her North Shore admission by Dr. Ramon Hechavarria, a physician certified in obstetrics and gynecology, and by Dr. Tomas Lopez, a general surgeon. Dr. Lopez noted in his consultation report that a pelvic bi-manual examination that he performed on April 21 showed an enlarged uterus corresponding to approximately 11-12 weeks' gestation. An ultrasound examination done on April 21 revealed a uterus measuring 11.0 x 7.8 x 7.8 centimeters and a viable intra- uterine pregnancy which was estimated by the radiologist to be 13-14 weeks' gestational age. On April 22, the patient underwent termination of her pregnancy by Dr. Hechavarria who noted in his operative report that both the pelvic ultrasound and a bi-manual examination revealed an intra-uterine pregnancy of about 11 weeks with a live fetus. An ultrasound performed intra-operatively confirmed that all fetal tissue had been removed and that there were no perforations. Infection and an incomplete termination are two of the recognized complications resulting from terminations of pregnancy. The fact that a patient suffers an infection or an incomplete termination does not, per se, indicate any negligence on the part of the physician. Respondent did not fall below the recognized standard of care by failing to perform an ultrasound on patient J. B. His examination revealed a gestational age consistent with the date identified by the patient as the date of her last menstrual period. Accordingly, there was no need to perform an ultrasound. Respondent did not fall below the recognized standard of care by misjudging the gestational age of the fetus. It is not uncommon for a physician to misjudge the length of gestation by several weeks. For example, Drs. Lopez and Hechavarria concluded the fetus had a gestational age of 11 weeks; yet, the ultrasound reported 13-14 weeks. Respondent did not fall below the recognized standard of care by using the wrong size of equipment to perform the termination of pregnancy. He used the proper equipment consistent with his judgment as to the length of gestation.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED THAT a Final Order be entered finding Respondent not guilty of the allegations and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 25th day of July, 1997, at Tallahassee, Leon County, Florida. LINDA M. RIGOT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 25th day of July, 1997. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jonathon P. Lynn, Esquire Stephens, Lynn, Klein & McNicholas, P.A. Two Datran Center, Penthouse II 9130 South Dadeland Boulevard Miami, Florida 33156 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309
The Issue The issues to be determined are whether Respondent fell below the minimum standard of acceptable nursing practice in violation of section 464.018(1)(n), Florida Statutes; engaged in unprofessional conduct by inaccurately recording in violation of section 464.018(1)(h), Florida Statutes, and Florida Administrative Code Rule 64B9-8.005(1); or made deceptive, fraudulent, or untrue statements in or related to the practice of her profession in violation of section 456.072(1)(m), Florida Statutes; and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, through its Board of Nursing, is the state agency charged with regulating the practice of nursing in the state of Florida, pursuant to section 20.43 and chapters 456 and 464, Florida Statutes. At all times material to this proceeding, Cynthia L. Denbow was a licensed ARNP in the state of Florida, holding license number ARNP 9283016. Prior to the instant case, Respondent has never had a complaint or discipline against her Florida Registered Nurse or ARNP licenses. Respondent has been certified by the American College of Nurse Midwives (ACNM) to practice as a CNM since 2006. Section 464.012(1)(a) provides that to be licensed as an ARNP, a nurse must be licensed to practice professional nursing and hold certification from an appropriate specialty board. Florida Administrative Code Rule 64B9-4.002(1)(b) provides that the ACNM is one of the specialty boards recognized by the Board of Nursing. Respondent, as a nurse-midwife, is not regulated under chapter 467, Florida Statutes, which governs “licensed midwives” in Florida. Respondent was the owner/operator of Gentle Birth Options (GBO), a birth center located at 296 Bayshore Drive, Niceville, Florida 32578. At GBO, Respondent offered midwifery services, which included prenatal care, child birth education classes, and labor and delivery medical support. In 2017, Respondent provided midwifery services to A.R., a 36-year-old female patient who was pregnant with her first child. Prior to becoming a client at GBO, A.R. and her husband, F.R., attended an open house at GBO designed to introduce prospective clients to the concepts of informed consent, and how the birthing center differs from the medical model of care. They then selected Respondent as the medical provider to guide them during their pregnancy, to provide one-on-one care to them during labor and delivery, and to make decisions to facilitate the birthing process. As a client of GBO, A.R. signed an informed consent form entitled: “Consent to Deliver in a Birth Center” documenting the date at June 16, 2017. The informed consent documents provided that no matter the quality of care, there remained a possibility of unforeseen events resulting in a poor labor outcome. The forms also informed A.R and F.R. that the midwife would transfer the laboring mother to the hospital if the course of labor was outside her scope of care. The informed consent forms also provided that, whenever possible, decisions regarding transfers would be made jointly by the laboring mother, the father, and the midwife. However, it warned that situations may arise where the midwife’s decisions and judgements must be trusted. During the course of the pregnancy, A.R. and F.R. attended prenatal appointments and child birth education classes at GBO. A.R. attended all the provided classes at GBO, while F.R. attended four to six classes. The classes provided at GBO were taught by either Respondent or her assistant, Christy Shields. The classes covered topics including: shared decision-making, reasons for transfer from GBO to the hospital, what to do when the client begins labor, and the role of the father during and after pregnancy. Breech presentation was discussed in the prenatal classes. However, transfer during labor due to breech presentation was not discussed, as GBO deals only with unplanned breech deliveries. GBO clients were taught not to count contractions, as they are an unreliable indicator of labor progression. GBO clients were provided materials indicating that the Fort Walton Beach Medical Center (FWB) performed an unreasonably high number of cesarean sections per year. That information influenced A.R. and F.R.’s negative feelings toward giving birth at FWB. Two months prior to the delivery date, A.R. and F.R. chose a birth plan that expressed a preference for limited vaginal exams, and a vaginal birth as opposed to a cesarean section. The birth plan preferences did not mean A.R and F.R. were opposed to vaginal exams prior to delivery, or delivery via cesarean section, if medically necessary. Both A.R. and F.R. assumed Respondent would conduct all medically necessary vaginal exams and arrange for a cesarean section, if medically necessary. Jenny Hernandez was hired as A.R.’s doula. A doula is a professional who attends a birth to provide physical and emotional support to the mother and father before, during, and after the birth. The delivery of A.R. and F.R.’s child was the first midwife birth attended by Ms. Hernandez, all others in her experience having been in a hospital with continuous fetal monitoring. On the morning of December 7, 2017, A.R., who was 40 weeks and 4 days pregnant, and 4 days past her due date, presented at GBO for a routine prenatal appointment. Respondent preformed a vaginal exam on A.R., and determined the position of the fetus by placing her hands on A.R.’s abdomen. When the exam was completed, Respondent told A.R. that the fetus was head down (vertex position), and that A.R. was 50 percent effaced and one centimeter dilated. Respondent did not perform an ultrasound on A.R. at this appointment, but did perform Leopold maneuvers which confirmed the vertex position of the baby. Respondent also informed A.R. that the baby was resting on her pelvis. Respondent gave A.R. a sash and some exercises designed to fix the fetus’s position before sending her to the chiropractor. The position of a fetus can change from vertex to breech at any time, including up to the very time of delivery. After the appointment A.R. and F.R. retuned home. Before 4:00 p.m., A.R. began feeling pains and felt she was experiencing the signs of early labor. At 3:56 p.m., A.R. called Respondent’s number, which was given out specifically for clients going into labor. Respondent did not answer. A.R. then called GBO’s front desk and was informed by Ms. Williamson that Respondent was unavailable. A.R. informed Ms. Williamson that she believed she was going into labor and was feeling crampy. Respondent was unable to take A.R.’s call because she was in the birthing suite assisting in another birth. When informed about the A.R.’s call, she believed it to be a “heads up call,” a common occurrence at GBO where expecting mothers call in to allow GBO to prepare for the impending birth. She also believed that the cramping could be related to the vaginal examination performed that morning. At 4:00 p.m. on December 7, 2017, A.R. texted her doula, Ms. Hernandez, and said “Hey Jenny, I think I might be in early labor, just FYI. I'll contact you in a little bit if I go into active labor, thanks” At 6:49 p.m., Respondent inquired into A.R.’s condition, texting “How are you.” A.R. replied “Doing well. Pressure waves getting a bit more intense, so took a hot shower. Making groaning cake with mom now.” A groaning cake is an intricate cake with lots of ingredients designed to take one’s mind off of the pains of early labor. Around 9:00 p.m., A.R. began feeling stronger contractions. F.R. called Respondent at 9:07 p.m. to give a labor update and report the rupture of A.R.’s membranes. Respondent assured F.R. that the labor was progressing normally and did not provide any other guidance. F.R. informed Respondent that he would call back when the labor progressed further. At roughly that time, A.R.’s birth doula, Ms. Hernandez, was called to come to their home. F.R. called Respondent at 9:39 p.m. to give a labor update and to inquire as to whether it was the appropriate time to come to GBO. Respondent replied that this was a normal labor progression and to wait for the doula to arrive before coming in. By the time Ms. Hernandez arrived at A.R.’s home, A.R. had begun to vomit and release a pink discharge. A.R.’s contractions were two to three minutes apart, and very intense. Based on the symptoms displayed by A.R., and the estimated time between contractions, Ms. Hernandez believed that A.R. was in transition between latent and active labor. The transitional period is the shortest stage of labor. The doula and F.R. jointly made the decision that it was time to take A.R. to the birthing center. F.R. called and informed Respondent that the birth party would be arriving at GBO in around 15 minutes. At no point before reaching the birthing center did A.R. or F.R. count contractions. There is conflicting evidence as to whether A.R. was screaming in pain before heading to GBO. Ms. Hernandez testified that A.R. was not screaming in pain while at her house, but rather was working hard, groaning, and exerting energy, stating that “I wouldn't say that she was out of control. She was working hard and I'd say, in my experience, she was coping well.” She further testified that A.R. was screaming only at the end while at GBO, immediately before her transfer to the hospital as described herein. Ms. Hernandez’s testimony is accepted. At 10:35 p.m., A.R., F.R., Ms. Hernandez, and A.R.’s mother arrived at the birthing center and were greeted by the medical assistant, Katherine Williams. A.R walked into GBO on her own. Ms. Williams accompanied A.R. to the birthing suite, and A.R. sat down on the bed. Ms. Williams’ job as medical assistant at GBO was to support the midwife during labor. Her duties included checking a client’s vitals upon admission into the birthing suite, documenting intrapartum and postpartum records, and comforting the mother and father during the birthing process. While it is disputed if Ms. Williams ever performed a check of vital signs on A.R. upon admission to the birthing suite, Ms. Williams testified that she did so, and the intrapartum records state that Ms. Williams documented A.R.’s blood pressure, respiration, temperature, and fetal heart tones. The report indicates A.R. was coping with contractions at this time. Ms. Williams’s testimony and contemporaneous records are accepted. Shortly after the birthing party arrived in the suite, Respondent and Ms. Shields entered the room. Respondent greeted the party, and observed A.R. in labor, but did not perform any physical examination. Ms. Shields saw the records of Ms. Williams’s vitals check when she entered the birthing suite. Respondent and her assistants watched and assessed A.R. in the birthing suite in an attempt to determine what stage of labor A.R. was in. Ms. Hernandez was massaging A.R.’s back, applying counterpressure, and generally offering encouragement. At 11:15 p.m., A.R. got up to go to the bathroom. She returned from the bathroom and sat at the foot of the bed. Ms. Shields then checked the baby’s vitals. A.R. alternated positions from the bed to the birthing stool and back. Respondent and her assistants continued to monitor A.R. to determine the stage of labor. At some point, Respondent left the room to review materials on stem cell extraction from the umbilical cord. F.R. called Respondent back into the birthing suite. Respondent indicated that A.R. did not seem to be handling the contractions well, and had begun to vocally express pain and breathe heavily. A.R. expressed the desire to get into the birthing tub, at which time Respondent asked A.R. if she would like her to perform a vaginal exam. A.R. responded in the affirmative. Respondent conducted the vaginal exam and informed A.R. she was 100 percent dilated and completely effaced, but that the baby was in breech position. Meconium was observed after the vaginal exam. The parties stipulated that the examination was performed one hour and seven minutes after A.R. arrived at GBO, making the time 11:42 p.m. Respondent informed A.R that it was her decision as to how to proceed with the breech delivery. Respondent told A.R. that she had performed unplanned breech deliveries and was comfortable with undertaking the delivery. Respondent gave A.R. two choices: give birth at the birthing suite; or give birth at the hospital where they would likely perform a cesarean section. There was conflicting evidence as to whether Respondent provided information to A.R. about the options for safe delivery based on the nature of the delivery and its imminence. Respondent testified that she informed A.R. that because the birth may be imminent, it could occur in the ambulance which can be dangerous due to a lack of available trained personnel and equipment, a conversation described in the intrapartum records. Respondent did testify that “I did not quote exactly what I said. I may not have used the word precipitous, but I told her, your labor is progressing fast, and that means the same thing.” Ms. Shields went to check the emergency cart because, to her, “it seemed like we were about to have a baby any second now.” F.R. and Ms. Hernandez testified that Respondent did not tell them that the birth was imminent or precipitous. However, they knew at a minimum that A.R. was 10 centimeters dilated and completely effaced, which would reasonably suggest that delivery could come quickly -- within 30 minutes according to Ms. Mitrega. F.R., Ms. Hernandez, or A.R. could not recall Respondent advising that an ambulance delivery could be dangerous, but recalled Respondent reiterating the downside of a FWB delivery. A complete review of the testimony of each of the witnesses, including GBO staff, indicates that the differences in the recollection of the witnesses were not so dissimilar as to suggest that any witness was intentionally fabricating their testimony. Rather, given the impact of the situation -- as stated by F.R., “all the air went out of the room” -- the differences in time, tone, and substance were, more likely than not, an artifact of the stress and tumult of the moment. The greater weight of the evidence indicates that Respondent gave A.R. the option of continuing with the delivery at GBO or going to FWB. A.R. initially agreed to continue with the delivery in the birthing suite. As stated by F.R., “I agreed, let's do this,” a statement reiterated by several witnesses. To be sure, the decision was influenced by information provided during birthing classes as to the cesarean delivery rate at FWB, and by Respondent’s assurance that she could manage the unplanned breech delivery. Such does not constitute “encouragement” as pled in the Administrative Complaint. Thus, the evidence is not clear and convincing that Respondent failed to meet the minimal standards of acceptable and prevailing nursing practice by encouraging A.R. to continue delivery at GBO after learning that A.R.’s fetus was in breech position, that Respondent engaged in unprofessional conduct as a result of the circumstances surrounding A.R.'s consent to continue the delivery at GBO after learning that A.R.’s fetus was in breech position, or that Respondent made deceptive and/or untrue representations in A.R.'s patient records regarding the decision to continue the delivery at GBO after learning that A.R.’s fetus was in breech position. After A.R. agreed to continue the birth at GBO, Respondent had to assess whether the birth was imminent in case there had to be a decision to transfer to the hospital. Respondent then allowed A.R. to push, stating that: I had to determine if the baby was imminent or not. It was an assessment. She had to push a few times before I could even decide if I had a minute to go use the phone and call -- call 911. The baby could have been born when I walked out the room. Her labor was progressing quickly. I had to establish if birth was imminent. There is conflicting evidence on the number of contractions A.R. went through at the birthing center before a transfer to FWB was initiated by Respondent. A discussion of the discrepancy and the charting thereof is set forth below. Regardless of the number of contractions, Ms. Hernandez indicated that after contractions on the birthing stool, Respondent got the fetal Doppler to measure heart tones. Respondent instructed A.R. to get on the bed on “all-fours” to get a better read on the baby’s heart rate because, as stated by Ms. Shields, “[a] lot of times if it's just the positioning thing, that will help the baby's heart rate just fine if the baby didn't like the position.” Respondent determined that the baby’s heart tones were decelerating during contractions, though they recovered to normal levels thereafter. The second incident of decelerating heart tones prompted the Respondent’s decision that this was a precipitous labor, and that it was time for transfer.1/ After the contractions described above, Respondent noted the baby was not descending normally, and noticed abnormal decelerations of the baby’s heart tones. Respondent told A.R. to stop pushing at this point. Respondent determined that the situation was emergent and left the room to call emergency services for hospital transport. Ms. Shields stayed with A.R. “encouraging her to breathe, [and] trying to discourage her from pushing if she had another contraction.” Ms. Williams retrieved the emergency cart and began to administer oxygen to A.R. Respondent called 911 and asked Ms. Shields to gather and print A.R.’s records for delivery to FWB. A.R. and the rest of her party were led to Respondent’s office where A.R. laid down on the couch to await the arrival of the ambulance. Respondent approximated the call with 911 took about five minutes to provide all the information the emergency operators were asking for. As the call progressed, Respondent transferred the phone to Ms. Williams so Respondent could complete the transfer records for the hospital and check on A.R. Respondent used the fetal Doppler to check fetal heart tones and performed an ultrasound to confirm the baby was in breech position. When the first responders arrived at GBO and were able to assume the care of A.R. and prepare her for transport, approximately 12 minutes after the 911 call was placed, Respondent called in a report to the Labor & Delivery unit at FWB. Deborah Wahlman, R.N., was the charge nurse that answered the call. Respondent gave a full report to Ms. Wahlman that included: A.R. was 40+5 weeks pregnant, complete, breech, and pushing. A.R. was transported from GBO to FWB, a distance of 11 miles, via ambulance. Respondent sat in the back of the ambulance with A.R., while F.R. sat in the front with the driver. Upon arrival at FWB, Respondent transferred full responsibility for the care of A.R. and her fetus to the hospital in accord with her physician protocols. It was not disputed, nor was it an issue, that Respondent correctly performed the steps related to A.R.’s transfer to FWB, ensured that pushing efforts were ceased, encouraged A.R. to breathe, administered oxygen, repositioned A.R., performed a bedside sonogram, and went with A.R. in the ambulance. Respondent provided FWB with handwritten and incomplete intrapartum notes, along with lab reports from A.R.’s 28th and 36th weeks. These lab reports included CBC’s, a glucose tolerance test, and a group beta test strip. She did not provide the OB labs to the hospital because the birthing staff lacked the time to obtain them. A.R. was taken in on a stretcher and admitted to the operating room after being asked preliminary health questions by the hospital staff. Respondent and F.R. were not permitted in the operating room. While waiting in the operating room, Respondent and her staff were completing the notes and forms detailing what occurred at GBO. Respondent and F.R. disagreed as to the number of times A.R. pushed at GBO. At the hearing, A.R., F.R., and the doula testified A.R. went through two to four contractions on the birthing stool. A.R. testified that she had perhaps three to four contractions on the bed before Respondent made the decision to go to the hospital. Respondent indicated that she documents contractions, rather than individual pushes that may occur during a contraction. She testified that a patient may push multiple times during a single contraction. Respondent testified as to her recollection that A.R. had two contractions during which she pushed several times before the decision to transfer her to the hospital was made. When she was charting, Respondent had to estimate how many pushes A.R. might have had in the 15 frenetic minutes or so between the discovery that the baby was breech and the call to 911. She asked Ms. Shields how many pushes she counted, and she indicated two or three. F.R. disagreed, indicating that A.R. pushed at least six times. Respondent construed the statements as meaning there were multiple pushes over two contractions, and charted it as such, logging “attempted to push x2 contractions.”2/ The evidence that Respondent was being untruthful both at the time she prepared the charts and at the hearing was not clear and convincing. Thus, the allegation that Respondent engaged in unprofessional conduct by inaccurately recording the number of times A.R. pushed after Respondent learned that the baby was in breech position is not supported by the applicable quantum of proof. The fetal heart rate with beats per minute (BPM) in the 80s was heard by Ms. Wahlman at FWB when A.R. arrived via ambulance, before A.R. was taken to the operating room. The fetal heart rate with BPM in the 60s was heard when A.R. was in the operating room. A.R. underwent an emergency cesarean section surgery performed by Jennifer Seaton, M.D. Dr. Plano, neonatologist, was called by the hospital staff to report for neonatal resuscitation. She arrived approximately eight minutes after delivery, and testified that “the baby had had normal heart rate in the ambulance ride over, but had had a decrease in the heart rate just prior to delivery and so -- so I proceeded to try to resuscitate a child that -- that according to the history, might have had had a heart rate ten minutes before.” After some time had passed, Dr. Seaton came in to the waiting room and informed F.R. and Respondent that the outcome had not been positive, and that A.R. and F.R.’s child had died. The child died minutes before birth as estimated by the pathologist who performed the autopsy. The autopsy report also documented that the child was diagnosed with cardiomegaly and myocarditis. The Department alleged that Respondent misrepresented to Dr. Seaton whether A.R. pushed while at GBO. Dr. Seaton testified that Respondent “stated that she did not ask the patient A.R. to push.” Respondent testified that the exchange with Dr. Seaton started when she asked “Did you make this patient push when you knew she was breech? And I said, no, I did not make her push. She chose to push. She was pushing spontaneously.” F.R.’s recollection of the initial exchange between Respondent and Dr. Seaton differed from both of theirs. The allegation that Respondent was falsifying information is undercut further by the fact that Respondent advised Ms. Wahlman that A.R. was breech and pushing when she called in the report to FWB. Without something further, the evidence is not clear and convincing that Respondent made deceptive and/or untrue representations to Dr. Seaton regarding her interactions with A.R. while at GBO as alleged in Count III of the Administrative Complaint. Respondent’s notes go up to 2:00 a.m. on December 8, 2017. Respondent testified that all of the notes were completed during the period at GBO, in the FWB waiting room, or shortly thereafter on December 8, 2017, when she was able to sit down at her computer and recollect the events as they happened. The electronic signature of December 19, 2017, was a result of Respondent leaving the record open to confirm her recollection of the time she called for the EMS was consistent with their records. The evidence is not clear and convincing that Respondent, or anyone on the GBO staff, modified her records on December 19, 2017, or that she made deceptive and/or untrue representations in A.R.'s patient records as alleged in Counts II and III of the Administrative Complaint. Standards of Care It is not the individual opinion of a qualified witness that establishes the standards of acceptable and prevailing nursing practice. Rather, it is “community standards” that define the appropriate standard of care. In order to establish the standard of care applicable to nurse midwives, Petitioner relied on the testimony of Joanne Mitrega, who was accepted as an expert in labor and delivery. Ms. Mitrega has been a CNM in Florida since 2001. Although she “came to Florida to join a birth center, a freestanding birth center,” her primary practice since then has been in a hospital setting or a private practice setting with two OB/GYNs. The last time Ms. Mitrega worked at a birth center was in 2002, and even that center was owned and operated by a hospital. Ms. Mitrega indicated that, when asked to develop an opinion regarding standards of care for CNMs: I had reviewed my own practice guidelines from my birth center, at which I used to practice and current practice guidelines, yes. Q And the guidelines from your birth center, are those the same guidelines that Ms. Denbow would be required to follow? A No. Every place has their own set of practice guidelines. Ms. Mitrega further testified that the standard of care is established through a practice’s operating guidelines and protocols, stating that: Every place I've practiced I had Standards of Care, I had guidelines, practice guidelines, which is the Standards of Care, and they were always provided to me by my group. Confirming Ms. Mitrega’s testimony as to the basis for an applicable standard of care, Ms. Richards stated that “in the State of Florida, a nurse midwife has protocols that are signed off by a physician and that's really kind of her governing body, like what she needs to follow.” When asked the basis for her opinion as to “the Standards of Care that are within the community,” particularly as it relates to a vaginal examination upon presentment at a birth center, Ms. Mitrega responded that they were derived from “within the community and establishments I have been a part of.” As indicated previously, the community and establishments with which Ms. Mitrega has recent experience include only hospital or hospital affiliated facilities. They do not include home birth or birthing centers similar to GBO. Ms. Mitrega testified that “everywhere I practiced there was a set of practice guidelines under which I had to practice and be compliant with.” Nonetheless, Ms. Mitrega did not review the protocols in place at GBO. Despite her testimony that every facility has their own set of practice guidelines and their own approved relationship with a physician in the form of signed protocols, her testimony as to standard of care was based on protocols established at her places of employment. As will be discussed herein, in light of Ms. Mitrega’s credible testimony as to the basis for a practioner’s standard of care, her failure to review Respondent and GBO’s operating practices and protocols diminishes the credibility and weight of her testimony that Respondent violated her applicable standard of care. Furthermore, Ms. Mitrega did not, with any degree of specificity, rely on sources she identified and acknowledged as authoritative as support for her opinions. Dr. Lane was accepted as an expert in midwifery. She is a certified nurse midwife, and specializes in home birth, outcomes in home birth and birth center deliveries, and vaginal breech deliveries. She has never practiced midwifery in Florida, but is familiar with community standards of midwifery in Florida, having taught midwifery classes in Destin, worked with community representatives in Florida, and reviewed the Nurse Practice Act. She was a co-author for the Home Birth Standards published by the ACNM, of which she is a member of the Home Birth Section and the committee for Full Practice Standards for Nurse Midwives. Ms. Mitrega recognized ACNM clinical bulletins and physician statements as being authoritative in the field of midwifery. Ms. Mitrega further recognized the ACNM, as the governing body for midwives, as “very influential in establishing the guidelines for us.” Dr. Lane reviewed the intrapartum records, birth plan, prenatal records, lab reports, and all other documents at issue in this case, along with the written complaint. Of critical importance is the fact that she reviewed Respondent’s collaboration agreement with her associated physician, and, thus, had a familiarity with the standard of care that would apply to Respondent. Dr. Lane knew Respondent prior to being asked to offer opinion testimony in this case. They were in school together, and Dr. Lane considered themselves to be friends. That, in itself, is not sufficient to demonstrate bias, and is not a reason to discount Dr. Lane’s sworn testimony. Ms. Richards was accepted as an expert in the Florida Standards for Nurse Midwifery. Ms. Richards is a nurse midwife who has been practicing in Central Florida since 2006. She owns a company providing midwifery care including prenatal, delivery, and postpartum care. Ms. Richards has practiced midwifery in a variety of settings, including both birth centers and hospitals. Vaginal Examination Ms. Mitrega identified four stages of labor, with the “second stage” being from complete dilation to delivery. The second stage for a first-time mother can be from three hours to as few as 30 minutes, with a mean of 50 minutes. By watching and listening to a patient, a midwife can “get an idea about what stage of labor she's in, . . . but if I don't do my pelvic exam, I am only guessing.” Therefore, in the hospital setting at which Ms. Mitrega practices, she performs an initial vaginal exam upon the patient arriving to establish a baseline. When asked when nurse midwives should perform their initial assessment and vaginal exam upon patient admittance, Ms. Mitrega testified: Again, if I'm admitting a patient, I've got to have all my information so I know what diagnosis to put and I know my plan for the patient. Q. Was that the standard when you were at the birth center? A. Yes. Q. That's the standard at the hospital? A. Yes. An initial assessment of a patient, including vaginal exam, was a part of any practice I have been part of. (emphasis added). As previously indicated, Ms. Mitrega’s practice for the 17 years she has been in Florida has been limited to hospital or hospital-affiliated facilities. She has no recent experience in home birth or birthing centers similar to GBO. Ms. Mitrega acknowledged the increased risk of infection and chorioamnionitis resulting from vaginal exams after the patient’s water breaks. Thus, “when the patient is ruptured, the membranes are ruptured, we tend to be mindful of how many vaginal exams we perform.” Dr. Lane corroborated that when a patient’s water has broken, vaginal examinations increase the possibility of infection, and opined that they should only be administered when there may need to be a change in management. Respondent’s operating protocols, and her agreement with A.R., establish that vaginal examinations were to be done minimally. Respondent indicated that A.R.’s delivery appeared to be progressing normally. Given that a vaginal exam had been performed the morning of December 7, 2017, Respondent did not believe another to be necessary, or within the general “non- invasive” practice regimen of a midwife. It was not until A.R. appeared to be having difficulty handling the contractions, combined with her desire to get into the birthing tub, that a vaginal examination was determined to be warranted. Dr. Lane and Ms. Richards, appearing on behalf of Respondent, opined that Respondent did not fall short of the minimum standard of care in performing a vaginal exam after one hour of observation. Dr. Lane testified that the practice of midwifery relies in large measure on non-invasive means of assessing the progress of labor. Thus, discussion and observation are within the standard of care in the absence of some sign of distress or complication. Dr. Lane testified that A.R.’s need to push so soon into her active labor could be taken as a sign of precipitous labor that could change management and, therefore, warrant a vaginal exam. Thus, Respondent’s administration of the vaginal exam after one hour of observation and assessment, and after A.R. began to vocally express pain and breath heavily, was appropriate based on the signs displayed by A.R. Given the totality of the evidence in this case, including the testimony of Dr. Lane and Ms. Richards, Petitioner did not prove, by clear and convincing evidence, that Respondent fell below the minimum standards of care applicable to nurse midwives when she waited to perform a vaginal examination, or that Respondent acted inconsistently with GBO’s policies and physician-approved protocols when she did so, as alleged in Count I of the Administrative Complaint.3/ Breech Birth/Attempt at Delivery Ms. Mitrega testified a breech baby can be delivered vaginally by “a skilled, trained provider who is trained in doing breech vaginal deliveries or in emergency -- in emergencies, or under an emergency situation.” When asked her opinion as to the standard of care for nurse midwives upon discovery of a breech birth, Ms. Mitrega testified: Under my practice guidelines and the birth center, as soon as I diagnose by my guidelines, as soon as I diagnose breech, I had to transfer the patients to physicians to the hospital under physician's care. (emphasis added). As indicated previously, Ms. Mitrega’s guidelines as a midwife member of a hospital staff, is not the standard of care for nurse midwives practicing in a free-standing birthing center, unaffiliated with a hospital. In addition to the foregoing, which indicates a lack of knowledge as to the standard of care for midwives other than those operating under her practice guidelines, the force of Ms. Mitrega’s testimony as to whether the standard of care was violated by Respondent in this case was effectively extinguished by the following: Q. . . . Couldn't a skilled nurse midwife who trained in breech deliveries be able to deliver a breech if it was imminent? A. If she's trained in doing so and her protocols allowing her to do so, yes. Q. Well, that was the situation here, wasn't it? A. I don't know. Q. Why don't you know? A. I don't know the protocols. I don't know if the midwife was trained in breech vaginal deliveries and her protocols were corresponding with that. Q. Well, that was a missing component that was important, wasn't it? A. Yes. Ms. Mitrega admitted, on several occasions, that she did not review GBO’s protocols and practice guidelines. Such an astonishing omission of such a critical element serves, in large measure, to decrease the weight to be afforded the witness’ testimony to near zero. Ms. Mitrega was unable to identify a guideline or standard providing that a skilled and trained midwife should not attempt to deliver a breeched baby vaginally if birth was imminent. She had no knowledge of the standard of care required to determine if a breech birth was imminent, or how many pushes are necessary to conduct an assessment on the imminence of a breech birth. In the course of her testimony, Ms. Mitrega admitted that if Respondent was trained in breech vaginal delivery, then it would be her opinion that A.R. would not have to be transferred immediately. Respondent testified that she has experience and training in delivering breech babies, though she has only delivered one breech baby at GBO, in 2017. There was no evidence to contradict her testimony. GBO’s policies and procedures provide that a patient presenting with a breech presentation is to be transferred to a hospital “if there is time for transport before birth.” However, Respondent and GBO staff will manage the breech birth in the event the patient presents too late for transport. Dr. Lane and Ms. Richards, appearing on behalf of Respondent, opined that Respondent did not fall short of the minimum standards of care in asking A.R. to push once breech delivery was discovered, or failing to immediately transfer A.R. once breech delivery was discovered. Dr. Lane testified that the goal of a midwife is to determine a safe environment for birth, and noted that certified nurse midwives are trained in how to manage surprise breech delivery. The GBO informed consent forms authorized Respondent to manage complications. Ms. Richards testified that certified nurse midwives are required to have their protocols signed off on by a physician. Respondent had done so. Respondent’s protocols authorized Respondent to deliver a baby if birth was imminent in a surprise breech birth, and she acted in accord with the required protocols. Dr. Lane testified that, based on the potential danger to the mother and child from giving birth in an ambulance, the most prudent course of action in this case was for Respondent to determine how quickly A.R. was expected to give birth. As to whether Respondent asking A.R. to push after the breech was identified violated the standard of care, Dr. Lane concluded that allowing A.R. to push over the course of roughly 15 minutes informed Respondent as to how fast the birth would likely occur, allowing her to make an informed choice as to the safest birthing environment. Dr. Lane further concluded that Respondent’s assessment to determine that birth was not imminent prior to transfer, including the observations of contractions and measurement of fetal heart tones, was reasonable and necessary. Based thereon, Dr. Lane opined that Respondent did not breach the standard of care by failing to immediately refer A.R. to a higher level of care when breech was diagnosed. Based on the totality of the evidence in this case, Petitioner did not prove, by clear and convincing evidence, that Respondent fell below the minimum standards of care applicable to nurse midwives when she failed to immediately refer A.R. to a higher level of care, or when she allowed A.R. to push through several contractions to assess the imminence of birth before effecting a transfer, as alleged in Count I of the Administrative Complaint. Recordkeeping As to the recordkeeping required of a nurse/midwife, Ms. Mitrega testified that late entry notes on intrapartum records are an acceptable practice, unless the charting is done at a much later date. Respondent testified that her birth assistant incorrectly charted the pre-transfer heart rate decelerations on the intrapartum record because she was not properly trained to diagnose or document the decelerations. Respondent testified she later charted the correct documentation in her Subjective Objective Assessment Plan. Ms. Mitrega testified that, in general, Respondent’s records were legible and accurate. Her testimony to that effect, and her belief that the entry bearing a signed date of December 19, 2017, was not, is as follows: Q. . . . You said that her records were done appropriately and legibly; correct? A. Right. Q. Prenatal records show the patient's care was documented properly, subject followed standard charts and way of charting to maintain records; correct? A. As far as the flow charts go, and as far as what I can see, yes, I have to agree that they were filled according to the rubrics. Q. Okay. And she had appropriate blood work and cultures down at the appropriate time for the standard of care? A. Yes. Yes. Q. Intrapartum records and intrapartum flow chart were filled out completely, timely and according to rubric? A. Yes. Q. And second stage documentation calls for entry every 5 minutes? A. Uh-huh. Q. And you see that was documented, as well? A. Yes. I do say, again, according to what they use at the center, it is filled out correctly, yes. Q. And that late entry note is an acceptable practice; is that right? A. Right. And I was referring to the note that was done at the hospital, when the patient arrived to the hospital, and I do say late entry note is acceptable. We do take care of patients and patients do come first and then we chart, when we find the next available moment. But when I was reviewing the case again, I did see that there was a really late entry note, the events were happening on December 7th, and there was a note from the December 19th. Q. Where are those? A. If I recall, again, reviewing the case, it was page 153. Q. Could that have been the page -- could that have been the date that it was signed? A. It was electronically signed but how do you sign a record if you don't enter the record? Q. It could be left unsigned; right? A. Right. But, to me, the record was redone, rewritten. (emphasis added). Respondent testified, credibly, that the electronic signature of December 19, 2017, was a result of her leaving the record open to confirm her recollection of the time she called for the EMS. She testified, without any evidence to the contrary, that she did not alter A.R.’s records after she initially prepared them on December 8, 2017. Ms. Mitrega’s testimony that the record was “redone, rewritten” was pure speculation, unsupported by competent, substantial evidence. For the reasons set forth herein, the evidence is not clear and convincing that Respondent, or anyone on the GBO staff, modified A.R.’s records on December 19, 2017, that the records kept and produced were materially inaccurate, or that Respondent made deceptive and/or untrue representations either to Dr. Seaton or in A.R.'s patient records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Nursing, enter a final order DISMISSING the Administrative Complaint against Cynthia Denbow, ARNP. DONE AND ENTERED this 26th day of December, 2018, in Tallahassee, Leon County, Florida. S GARY EARLY 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 26th day of December, 2018.