Findings Of Fact John D. Elder is a site worker at Port St. Lucie High School, having first been employed by the St. Lucie County School Board as a temporary employee in the summer of 1993. When first employed, Mr. Elder rejected the option to enroll in the employer's insurance plan. In September 1993, Mr. Elder was given an employer's insurance form allowing ninety days for enrollment. On November 12, 1993, he completed the form and became eligible for certain benefits on January 1, 1994. The St. Lucie County School Board Medical Benefit Plans, in which Mr. Elder enrolled, excludes coverge for pre-existing conditions until the end of 12 months of continuous coverage. The plans include the following definitions: A pre-existing condition is an injury, sickness or pregnancy or any condition related to that injury, sickness or pregnancy, where a diagnosis, treatment, medical advice or expense was incurred within twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include any injury, sickness or pregnancy or related condition that manifested itself twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include the existence of symptoms which would cause an ordinarily prudent person to seek diagnosis, care or treatment within twelve (12) months prior to the effective date of this coverage. (Emphasis Added.) From 1985 to 1988, Mr. Elder was treated by Dr. Urban who, on March 24, 1988, performed an electrocardiogram ("EKG"), which was normal. Dr. Urban treated Mr. Elder for respiratory illnesses, such as bronchitis and pleurisy, for back and shoulder muscle spasms, bursitis/tendonitis, and for high blood pressure. On September 21, 1988, Mr. Elder first saw Dr. Richard Dube. On that day, his heart rate was 62, as compared to the normal range of 60 to 100. In October 1988, Dr. Dube treated Mr. Elder for an inflammation of the muscle behind his shoulder. In December 1988 and January 1989, he treated Mr. Elder for high blood pressure and headaches. In July 1991, Mr. Elder called an ambulance and was taken to the hospital complaining of pain in his neck, across his shoulders, and down his arms. Among other tests, an EKG was performed. The diagnosis was tendonitis in his right shoulder. Later that same year, Mr. Elder complained of heart burn. Dr. Dube treated him for epigastric distress and high blood pressure. Blood test analyses of his cholesterol and high, low and very low density lipid levels indicated a cardiac risk factor of 10.3 for Mr. Elder, which is more than twice the standard male risk factor of 5.0. Dr. Dube ordered blood tests again in January 1993, at which time Mr. Elder's cholesterol and high density lipid levels were still high, but had decreased, reducing the cardiac risk factor to 8.0. Dr. Dube also referred Mr. Elder for an ultrasound of the gallbladder, which was diagnosed on January 29, 1993, as having calcification, which could represent a gallstone, and probably having a small polyp. At the same time he treated Mr. Elder for carpal tunnel syndrome and temporomandibular joint syndrome ("TMJ"). Most recently, on July 27, 1993, the same tests were repeated. With cholesterol in the normal range, the cardiac risk factor was decreased to 6.5. In the fall of 1993, Mr. Elder's complaints were diagnosed as episgastric reflux. To reassure Mr. Elder, Dr. Dube ordered another EKG, which was performed on November 23, 1993, and was normal. On January 3, 1994, Mr. Elder's complaints of ongoing pain caused Dr. Dube, who suspected he had a hiatal hernia, to refer him to Dr. Dan G. Jacobson for an upper endoscopy. Dr. Jacobson recorded a history of episgastric/chest pain, hypertension, ulcers and arthritis. Dr. Jacobson also noted a family history described as "remarkable for heart problems, heart attack." The admitting diagnosis was "history of episgastric pain refractory to medical therapy." Dr. Jacobson performed the endoscopy and diagnosed mild stomach gastritis. Based on a two week history of epigastric and chest pain, and his conclusion that the pain was too severe to result from the endoscopy findings, Dr. Jacobson consulted a cardiologist. Dr. Robert N. Blews, a cardiologist, saw Mr. Elder in the hospital. The history taken by Dr. Blews noted (1) that Mr. Elder's father died of a heart attack at age 68, and that his mother had coronary bypass surgery at age 48 and died at age 59, (2) that the onset of "chest tightness" was approximately one year prior, and (3) that he has a history of cervical spine disease. Dr. Blews' notes also reflected a change in the pattern of the chest pains in the last one to two months, and additional changes in the last two weeks. The longest episodes of pain were lasting from 20 to 30 minutes, with associated sweating and shortness of breath. Mr. Elder also told Dr. Blews that the pain could be with exercise, at rest, could awaken him, and occurred while he was just walking to his car. The report describes Mr. Elder as having a history of smoking. The EKG which Dr. Blews ordered on January 8, 1994 showed a major blockage on the left side of the heart, and is significantly different from all of the prior EKGs, including that taken on November 23, 1993. Dr. Blews concluded that Mr. Elder was having angina, or a decrease in the blood supply to his heart two weeks, two months, and a year before January 1994. Mr. Elder's wife, Florinda Elder, has been aware of his complaints of stomach problems for 10 years, but had no knowledge of his heart problems until January 1994. She was not aware of his having ever smoked or complained of shortness of breath. Although she was at the hospital, Mrs. Elder was not in the room when Dr. Blews took her husband's medical history. Mr. Elder's shoulder and muscle aches, and cervical spine pain are the result of a serious car accident in 1969. The pains are aggravated by cold weather. Mr. Elder claims to have been under the effects of anesthesia at the time Dr. Blews took his medical history, and denies having had a year of chest tightness, shortness of breath, or difficulty walking to his car. He has not smoked for 20-25 years, which is not inconsistent with Dr. Blews' report of a "history of smoking." Mr. Elder's attempt to undermine Dr. Blews history is specifically rejected. The McCreary Corporation is the administrator of the St. Lucie County School Board's self-insurance plan, which contracts with a consultant, Independent Health Watch. Kay Trentor, R.N., reviewed the claims submitted by Mr. Elder, and concluded that his coronary artery disease was a pre-existing condition. In part, Ms. Trentor was relying on Dr. Blews history of a year of "chest tightness." Mr. Elder's records were also sent for peer review, to two other consultant organizations, Professional Peer Review, Inc. and Medical Review Institute of America, Inc. They, in turn, sent the records to Board certified cardiologists, with cardiovascular disease subspecialties. The first report concludes that Mr. Elder "should have known that he had coronary disease because he had multiple risk factors for heart disease," and that "if he was reasonably prudent he would have had this taken care of during the time he was having chest pain walking to the car." The second peer review report also notes a year of chest tightness, with symptoms worsened "over the two months preceding the admission, but . . . not recognized as cardiac until the hospitalization on January 7, 1994." The report concludes that coronary artery disease was not diagnosed until after the effective date. The second report was prepared by Ronald Jenkins, M.D., who believes that Drs. Dube and Jacobson, "seemed to be focusing on gastrointestinal diagnoses . . . and had kind of missed the boat, so to speak . . .," but that "an ordinarily prudent person with John Elder's symptoms which he reported prior to January 1, 1994, [would] have sought medical treatment for those symptoms." Coronary artery disease takes years to develop, but is erratic in manifesting itself, with some people having no symptoms to severe symptoms over a matter of hours. Dr. Dube described it as "silent" coronary disease. Dr. Blews estimates that a heart attack is the first symptom in 40 percent of patients. There is no dispute that Mr. Elder has had other medical conditions, including TMJ, arthritis, and gastroenterological problems. Dr. Jenkins believes the most important manifestation of coronary artery disease was upper precordial chest tightness going to the left upper extremity as well as to the throat. When the history indicates that the tightness occurs with exercise, according to Dr. Jenkins that gives 90 percent confidence that it is anginal chest pain. That confidence level increases to 95 percent when he notes that Mr. Elder told Dr. Blews that chest discomfort occurs when he walks to his car. Without that history, however, Dr. Jenkins would not be able to conclude that the chest discomfort is due to heart disease or that the cardiac condition manifested itself prior to January 1, 1994. Dr. Jenkins described chest heaviness, aggravated by being in cold weather, as a symptom of coronary disease. The same pain without multiple risk factors, occuring irregularly, is a reason for "looking into other alternative diagnoses." Dr. Jenkins also acknowledges that episgastric reflux can cause chest discomfort and throat pain, and that cervical spine degenerative disc disease can cause a radiation of symptoms into the upper extremities, as it did when Mr. Elder called an ambulance in 1991. Dr. Blews did not have trouble getting a complete, detailed history from Mr. Elder. He typically has to elicit a more specific description from patients complaining of chest discomfort. He gives choices such as pain, burn, stab, jab, tight, squeeze or pressure, from which Mr. Elder chose "tight." Dr. Blews also found that Mr. Elder had chest wall pain in several spots or fibrosistitis, which is not a symptom of heart disease. Chest tightness could also be attributable to asthma, according to Dr. Blews, but with radiating pain into the left arm, jaw, and throat, shortness of breath, and sweating, he was certain Mr. Elder had heart disease. All of the doctors agree that Mr. Elder's heart disease existed before January 1, 1994, and that he had no diagnosis, treatment, medical advise or expense related to heart disease in the 12 months prior to January 7, 1994. There is no evidence that he was ever evasive or uncooperative with doctors. On the contrary, Mr. Elder was consistently described in doctor's notes and hospital records as anxious or concerned about his health. Coronary artery disease had not manifested itself to Mr. Elder or his doctors prior to Dr. Jacobson's decision to consult with Dr. Blews. "Manifest" is defined in Respondent's exhibit 9, a page from the International Classification of Diseases, 9th Revision, 1995, or ICD-9, as "characteristic signs or symptoms of an illness." The doctors who testified, in person or by deposition, described every sign or symptom experienced prior to Dr. Blews' consultation, as also being a sign or symptom of Mr. Elder's other medical conditions. Mr. Elder's symptoms might have been diagnosed as also indicating that he had heart disease, if he had been referred to a cardiologist sooner. There is no factual basis to conclude that Mr. Elder, or any ordinarily prudent person, should have sought diagnosis, care, or treatment for heart disease when, in fact, his doctor reassured him that his EKG was normal.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Respondent enter a Final Order approving Petitioner's claim for payment of medical expenses in the amount stipulated by the parties. DONE AND ENTERED this 12th day of July, 1995, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-0373 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Accepted in preliminary statement and Findings of Fact 2. Accepted in Findings of Fact 3. Subordinate to Findings of Fact 3. Accepted in Findings of Fact 22. Accepted in Findings of Fact 5-8. Accepted in Findings of Fact 5-8 and 12. Accepted in Findings of Fact 7 and 10. Accepted in Conclusions of Law. Accepted in or subordinate to Findings of Fact 6. Respondent's Proposed Findings of Fact. 1. Accepted in Findings of Fact 1 and 2. 2-3. Accepted in Findings of Fact 2. 4-5. Accepted in Findings of Fact 3. Accepted as corrected in Findings of Fact 23. Accepted in Findings of Fact 9. Accepted in Findings of Fact 8 and 9. 9-12. Accepted in or subordinate to Findings of Fact 9. 13-15. Accepted in Findings of Fact 20. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 20. Accepted in or subordinate to Findings of Fact 15-23. Accepted in preliminary statement and Findings of Fact 13. Accepted in or subordinate to Findings of Fact 14-16. Accepted in Findings of Fact 14 and 15. Accepted in Findings of Fact 16. Accepted in Findings of Fact 8. Accepted in Findings of Fact 9 and 20. Accepted in Findings of Fact 23. Accepted in Findings of Fact 17. Accepted in Findings of Fact 23. Accepted, but Dr. Dube's testimony was found credible and corroborated by his notes. COPIES FURNISHED: John T. Kennedy, Esquire The Injury Law Offices of John T. Kennedy 309 East Osceola Street Suite 306 Stuart, Florida 34994 C. Deborah Bain, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Lane, P.A. 1645 Palm Beach Lakes Boulevard Suite 700 Post Office Box 2508 West Palm Beach, Florida 33401 Frank T. Brogan Commissioner of Education The Capitol Tallahassee, Florida 32399-0400 Dr. David Mosme, Superintendent St. Lucie County School Board 2909 Delaware Avenue Ft. Pierce, Florida 34947-7299
Findings Of Fact Respondent is a lay midwife licensed by the state of Florida. She has practiced as a licensed lay midwife in Florida since 1981. Respondent began her training in Boston, Massachusetts, in 1975 when she began participating in an apprenticeship program under the supervision of two Board-certified obstetricians. That training lasted for three years and included self-study, seminars, and workshops. As part of that apprenticeship program, Respondent delivered one hundred babies under the supervision of those physicians. After moving to Florida, Respondent obtained her license as a lay midwife after attending fifteen births under the supervision of a physician and after taking a written and oral examination. Since being licensed in Florida, Respondent has attended and graduated from the South Florida School of Midwifery. She has subsequently been a preceptor and instructor at that School and is on the Board for the School. At the time of the final hearing in this cause, Respondent was only two months away from receiving her nursing degree. Respondent is a member of the Midwives Association of Florida. During the course of her licensure in Florida, Respondent has attended all types of continuing education programs, particularly in the field of maternal and child health. While licensed in the state of Florida, she has attended between five hundred and seven hundred births, sometimes as the primary caregiver, sometimes assisting other midwives, and sometimes assisting physicians during hospital births. At all times material hereto, Respondent has maintained an ongoing relationship with Dr. Atilla Eagleman, an obstetrician and gynecologist. She frequently consulted with Dr. Eagleman, and he performed risk assessments on Respondent's patients. In other words, Dr. Eagleman was Respondent's "back-up" physician. Dr. Eagleman became Board-certified in December, 1990. When patient Sandy Freireich first consulted with Respondent on May 11, 1989, Freireich was seventeen to eighteen weeks pregnant with her fourth child. Respondent told Freireich that in order for her to be accepted as one of Respondent's patients, she needed to provide Respondent with proof that she had obtained an initial risk assessment by a physician. Freireich told Respondent that she had obtained that examination from her regular doctor who was an obstetrician and that she would bring Respondent a copy of her medical records documenting that examination on her next visit. Since Respondent performs an initial risk assessment on her patients, she did so with Freireich and determined that she was a low-risk patient. On at least seven occasions, Respondent told Freireich that Freireich had to provide Respondent with a copy of the initial risk assessment records from Freireich's physician. On each occasion Freireich promised to provide such a record. Respondent also strongly encouraged Freireich to see Dr. Eagleman and have him perform an initial risk assessment. Freireich agreed to do so. Respondent also requested permission from Freireich to allow Respondent to obtain Freireich's records directly from Freireich's doctor by having Freireich sign a medical records release form. Freireich insisted that she wanted to speak to her physician to make sure her doctor understood rather than simply sending him a form to release her records. Along the way Freireich missed several appointments with Respondent. For those appointments which she kept, she failed to bring with her the promised documents. On September 6, 1989, when Freireich was 32.4 weeks pregnant, she signed a medical release form authorizing Respondent to obtain her medical records directly from her doctor. On that visit, Respondent recommended to Freireich that she obtain her third trimester risk assessment from Dr. Eagleman. On September 14, 1989, Respondent received records directly from Freireich's obstetrician. Those records did not contain an initial risk assessment for Freireich's current pregnancy. On September 20, 1989, when Freireich was 34.4 weeks pregnant, Respondent caused Freireich to receive a risk assessment and a physical and prenatal examination by a certified nurse midwife in Respondent's office. That risk assessment also revealed that Freireich was a low-risk patient. It is unknown whether Freireich ever obtained an initial risk assessment during her first twenty-eight weeks of pregnancy. It is uncontroverted, however, that Respondent never received proof of such an initial risk assessment by a physician or by a certified nurse midwife. Furthermore, it is clear that Respondent consistently encouraged Freireich to obtain an initial risk assessment by a physician, and that it was Freireich who failed or refused to provide proof that such had been performed. In 1987 the Department proposed a number of changes to the rules regulating the practice of midwifery. The Florida Midwives Association challenged the proposed rules, and the Association and the Department engaged in a long-term dialog thereafter. New rules did not become effective until 1991. Although there were existing rules in place during that interim period, it became a common practice for midwives to contact Anne Richter, a consultant for the Department's midwife program. Based upon the information provided to her by a midwife, Richter would tell the midwife to care for a particular patient pursuant to the existing rules or pursuant to the proposed rules. It was common knowledge among the midwives in the state of Florida that the Department was informally allowing midwives to practice under the proposed rules rather than the existing rules and that one could call Anne Richter to obtain a "waiver" of rule requirements. On one occasion, Respondent had telephoned Richter regarding a patient who had come to Respondent when she was thirty weeks pregnant and had not obtained an initial risk assessment during her first twenty-eight weeks of pregnancy. Richter told Respondent that it was permissible for Respondent to accept that patient whose only risk factor was starting care after twenty-eight weeks. Respondent did not accept that patient. Although Respondent had intended to telephone Richter to seek permission to continue providing care to Freireich, Respondent neglected to do so. On October 30, 1989, Freireich left a message cancelling her appointment for that day. Later that afternoon she contacted Respondent to advise Respondent that she was in labor. She declined to allow Respondent to come to Freireich's home until after 8:30 p.m. because she wanted her other children to be asleep before Respondent got there. Respondent arrived at the Freireich home at 8:50 p.m. She assessed Freireich's labor, performed a physical examination, and began attending to Freireich's needs during labor. At 11:30 p.m., the fetal heart rate was 150. The patient took a shower. When she finished her shower at 11:50 p.m., Respondent checked the fetal heart rate and found that it had decreased to 90. Respondent appropriately instructed the patient to lay on her left side and gave her oxygen at six liters since the deceleration in the heart rate may have been indicative of a problem that needed to be rectified. At 11:53 p.m., Respondent appropriately checked the fetal heart rate and again found that it was 90. Respondent then assessed the patient and found the patient to be fully dilated with the baby at between 0 and +1 stations. Since the patient was fully dilated, Respondent instructed her to push. Respondent again checked the fetal heart rate and found that it had decelerated to 60. That the patient had a history of having rapid deliveries and was a multipara (had previously had one or more viable births) was significant in that it was very likely that with good expulsive efforts the baby would be delivered in a short time. Respondent was concerned when she got the decelerated fetal heart rate but believed birth to be imminent. An experienced birth practitioner can judge whether delivery will be expeditious. At 11:58 p.m. the baby was at the +2 station (half the way down the birth canal, i.e., half way out). The fetal heart rate was 60 when Respondent again checked. Respondent's extensive training and experience had made her aware that it was not unusual to encounter a decelerated fetal heart rate directly prior to birth. A deceleration of the fetal heart rate at the final stage of labor can result from "head molding," and the rotation of the baby. In other words, it is very common to have a fetal heart rate drop due to head compression and the transverse lie of the head during the final stages of delivery. In 98% of those cases, the decelerated fetal heart rate will return to base line. In Respondent's previous experience, babies who had similar deceleration in their heart rate came out vigorous and robust, or may have needed a little tactile stimulation or warmth to be resuscitated, but always came out normal. Her training dictated that the proper procedure was to assess whether delivery was imminent. Respondent knew that a heart rate of 60 sustained for a few moments with no progress would be considered an emergency situation necessitating physician consultation or contacting emergency medical services for transportation to a hospital. On the other hand, a fetal heart rate of 60 sustained for a few moments with progress was not unusual, and the best course of action was to facilitate delivery of the baby. Since her patient was having strong contractions, was making good expulsive efforts, and the baby was descending rapidly down the birth canal, Respondent knew that birth was imminent. Exactly twelve minutes after the patient came out of the shower, the baby was delivered. The baby was stillborn. Respondent had no indication prior to the delivery of the baby that the baby would be severely compromised or dead. Respondent is fully trained in resuscitation of babies. She is certified in medical CPR, has taken many continuing education courses in emergency procedures, and is certified in and carries with her the equipment necessary for neonatal resuscitation: neosuctioning, an Ambu Bag, and oxygen. When the baby was delivered at 12:02 a.m., Respondent caused one of the adults present to contact fire rescue. Respondent immediately began resuscitation efforts and continuously attempted to resuscitate the baby until the fire rescue unit arrived, which was fifteen minutes after fire rescue was called the first time. Between the first decelerated fetal heart rate and delivery of the baby twelve minutes later, Respondent did not refer the patient to a physician or consult with Dr. Eagleman because to do so would have taken time away from managing a potentially dangerous situation and because she knew that Dr. Eagleman would merely tell her to get the baby delivered. Further, Respondent did not consider the drop in the heart tones to be abnormal requiring her to refer the patient to a physician since there was rapid progress and birth was imminent. Dr. Eagleman verified during the final hearing in this cause that had Respondent contacted him during the twelve minutes in question to report the decelerated heart rate, he would have told her to get off the telephone, go back to her patient, and "get the baby out." Respondent had never previously delivered a stillborn. There is no suggestion made in this record either that Respondent should have known that the baby would be stillborn or that Respondent contributed in any way to cause that unfortunate outcome. Respondent contacted Anne Richter to advise her what had happened and subsequently sent written reports to Richter detailing her care of patient Freireich. Petitioner has never before taken disciplinary action against Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered Finding Respondent guilty of violating Rule 10D-36.042(1), Florida Administrative Code (1989); Finding Respondent not guilty of violating Rule 10D-36.46(4)(e), Florida Administrative Code (1989); Finding that no disciplinary action should be imposed because the violation was neither willful nor repeated; and Dismissing the Notice of Formal Reprimand filed in this cause. DONE and ENTERED this 31 day of March, 1992, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 SC 278-9675 Filed with the Clerk of the Division of Administrative Hearings this day of March, 1992. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 91-1953 Petitioner's proposed findings of fact numbered 1, 2, 7, 8, 15 and 16 are adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 3-6, and 9-14 are rejected as not being supported by the weight of the competent evidence in this cause. Respondent's proposed findings of fact numbered 1-9, 12, 13, 15, 19-33, and 35-39 are adopted either verbatim or in substance in this Recommended Order. Respondent's proposed finding of fact numbered 10 is rejected as not being supported by the weight of the competent evidence in this cause. Respondent's proposed finding of fact numbered 18 is rejected as being subordinate to the issues herein. Respondent's proposed findings of fact numbered 11, 14, 16, 17, 34, and 40 are rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. COPIES FURNISHED: Karen Miller, Esquire District IX Legal Counsel Department of Health and Rehabilitative Services 111 Georgia Avenue West Palm Beach, Florida 33401 Thomas G. Sherman, Esquire 218 Almeria Avenue Coral Gables, Florida 33134 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations that Respondent violated the provisions of Subsections 458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient M.R., as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0077248. Respondent is a vascular surgeon, who is not board-certified in his area of practice. On November 27, 2000, Patient M.R., a 70-year-old male, was admitted to ORMC for a right-side carotid endarterectomy. Patient M.R. initially presented to Respondent in October 2000 with a number of health conditions, including chronic obstructive pulmonary disease (related to a 54-year history of smoking), cerebral vascular disease, atherosclerotic changes, and hypertension. Patient M.R. had a significant cardiac condition which resulted in a bypass procedure. It was determined at that time that Patient M.R. had significant stenosis in both carotid arteries which would require Patient M.R. to undergo two separate procedures, known as carotid endarterectomies. The left carotid artery was the subject of the first procedure in October 2000. Patient M.R. tolerated this procedure with no complications. Subsequent to the first carotid endarterectomy, but prior to the second, Patient M.R. suffered a transient ischemic attack (TIA), which is commonly referred to as a "mini-stroke." The symptomatic clinical presentation placed Patient M.R. in a high-risk category for peri-operative stroke. Respondent performed a right carotid endarterectomy on Patient M.R. on November 27, 2000. This requires the clamping of the artery in two locations, using a shunt to allow for the flow of blood. The incision must be made length wise in the controlled portion of the artery using an instrument to clear out the interior or lumen of the artery. This is done to reduce the stenosis and allow for better blood flow, without disbodying any particle from the wall of the artery. Once this is completed, the incision is patched, the clamps and shunt are removed, and the outer skin incision is closed. During the course of the above-described carotid endarterectomy, Respondent used a patch angioplasty with intra- operative shunt, which was manufactured from a pediatric feeding tube, and peri-operative neurologic monitoring. Immediately after the operation, the patient appeared to tolerate the procedure well, but was lethargic. Patient M.R. exhibited good movement in all four extremities and appeared to be neurologically intact, although he underwent extreme fluctuation in blood pressure. Patient M.R. was placed on ventilator support. The next morning, November 28, 2000, Patient M.R. had swelling and a hematoma in his neck on the right side, in the area of the incision. Respondent returned Patient M.R. to surgery, for exploration and evacuation of the hematoma. During the course of this second operation, Respondent observed a lot of swelling and edema in the operative site, but not much blood. Respondent evacuated the hematoma, and the carotid artery was found to have good blood flow. Later in the evening on November 28, 2000, Patient M.R. developed an acute neurologic deficit and was returned to the intensive care unit (ICU) at ORMC. Respondent ordered a Computerized Tomographry Scan (CT Scan) of the patient and an arteriogram. The results of the CT Scan showed a probable right occiptal infarct (stroke). The arteriogram showed significant occlusion of the right carotid artery extending to the carotid siphon. Patient M.R. was returned to the operating room in the early morning hours of November 29, 2000. Respondent made the decision to reopen the surgical area in an effort to resume blood flow in the right carotid artery that was seen to be occluded on the angiogram. Assisting Respondent on this November 29, 2000, procedure were John Horowitz, M.D., a board- certified vascular surgeon with nine years of experience, and Joseph Muller, M.D., a third-year general surgical resident at ORMC. During the November 29, 2000, procedure, Respondent reopended the previous incision in the skin and partially opened the patch that had previously been used over the carotid artery itself. Respondent performed a thrombectomy using a Fogarty "balloon" catheter in an effort to extract any debris that was causing the stenosis in the carotid artery. The balloon is placed into the carotid artery itself and is pushed up into the artery until it has passed whatever occlusion is present. Then the balloon is inflated and pulled back out, pulling with it any debris that is located within the artery. Near the conclusion of this November 29, 2000, procedure, a small piece of tubing was discovered in the surgical field. The piece of tubing was handed to Dr. Horowitz, who examined it and then placed it on the surgical tray. This piece of tubing was the same size, slope, and material cut from the feeding tube which was used as a shunt in the first surgery on November 27, 2000. There is conflicting testimony regarding the precise size and location of this piece of tubing that will be discussed below. What remains undisputed based upon the record in this case is that Respondent completed the surgical procedure on November 29, 2000, by closing the incision in the carotid artery and also in the skin of the neck. Dr. Muller is currently a surgical resident at ORMC, as he was at the time of the November 29, 2000, procedure. Dr. Muller testified that he had approximately two years and five months of residency training prior to the procedure in question. He estimated that he had observed approximately ten to 15 carotid endarterectomies. Dr. Muller testified that he observed a clear and slightly opaque piece of pediatric feeding tube coming out of the lumen of the artery as Respondent was evacuating debris after the inflation of the Fogarty balloon catheter and after about three passes of the catheter. Dr. Muller also testified that the piece of tubing in question was two or three centimeters in length. The other witnesses to this event testified that the piece in question was two to three millimeters in length. Dr. Muller's description of the position of the surgeon and assistant surgeon was also contrary to that of the other witnesses. Dr. Muller also testified that he did not know Patient M.R.'s medical history or his previous hospital course of treatment. Dr. Horowitz, the senior physician assisting, is a board-certified vascular surgeon who has performed several hundred carotid endarterectomies. He testified that he was called in by Respondent to assist on the surgical procedure which took place in the early morning hours of November 29, 2000. He found the piece of tubing located somewhere within the surgical field, remote from the carotid artery. He was certain that it was after Respondent had cleared the artery with the use of the Fogarty balloon catheter and had cleared the surgical wound. Dr. Horowitz testified that he saw a piece of tubing among the debris that had been evacuated from the surgical wound. It was not in the lumen of the artery. He picked up the piece of tubing in question with his thumb and forefinger and examined it. He testified that it was approximately two to three millimeters in length. He agreed that the material was consistent with the pediatric feeding tube that was used to create a shunt for the first procedure. Dr. Horowitz's testimony is credible and persuasive. Dr. Horowitz also gave his opinion that based upon his observation of the November 29, 2000, procedure, he did not believe that Respondent deviated from the standard of care in his treatment and care of Patient M.R. Patient M.R. was returned to the ICU, where he deteriorated and showed evidence of complete lack of brain stem reflexes. Patient M.R. was later pronounced brain dead, and he subsequently died on November 30, 2000. Gregory Schreiber, M.D., was the anesthesiologist who was present for a portion of the November 29, 2000, procedure. Dr. Schreiber testified that he was present during the beginning portion and the end portion of the procedure, when anesthesia is introduced and when anesthesia is abated. He was not present in the operating room when the piece of tubing was found. Further, there was a drape that separates the operative field from the anesthesiologist during the course of this procedure, which would have prevented Dr. Schreiber or his assistant from being able to see into the operative field directly. Dr. Schreiber noted that Patient M.R. was considered a very high-risk patient, whose multiple co-existent diseases posed a constant threat to his life when he presented for this surgery. In addition to the testimony outlined above, Petitioner also introduced three affidavits into evidence. One affidavit was that of Lata Bansal, M.D., a neurologist who was brought in for consultation after the November 29, 2000, procedure. Dr. Bansal swore in her affidavit that when she first saw Patient M.R. he was already brain dead. She otherwise did not have specific recollection of Patient M.R. The affidavit of Peter D. Taylor, M.D., a cardiac specialist, stated that he recommended a Thallium stress test for Patient M.R. prior to carotid surgery. The stress test was conducted on October 17, 2000, and revealed no ischemia but moderately decreased left ventricle function. Because he had no ischemia, Dr. Taylor opined that Patient M.R. was at an increased but acceptable risk for carotid surgery. The affidavit of Marita Lu, Registered Nurse, who was present during the November 29, 2000, procedure, stated that she could remember very few details of Patient M.R.'s case, other than she has the "impression" that something was recovered from the wound and that when she asked whether there was a specimen, she was told there was no specimen. Nothing in her affidavit indicates to whom she asked this question regarding the specimen nor is there any indication who responded to her question. Respondent is a board-certified general surgeon who is eligible for a special certification in vascular surgery and who was working at a vascular surgery group in Orlando, Florida, as of October and November of 2000. Respondent no longer practices in the State of Florida. He currently is an assistant professor of surgery and director of endovascular surgery at Creighton University in Omaha, Nebraska. Respondent described in detail each of the three procedures he performed. On November 27, 2000, the original procedure on the right carotid artery proceeded in routine fashion. Respondent provided an exemplar, which was admitted into evidence, of a pediatric feeding tube which is substantially similar to the pediatric feeding tube utilized in the November 27, 2000, procedure on Patient M.R. He utilizes a portion of the pediatric feeding tube as a shunt in his carotid endarterectomy procedures. He demonstrated at the final hearing that the pediatric feeding tube itself is so flexible as to be incapable of breaking. The only means of cutting it down is through the use of surgical instruments. He also indicated that there was no way to further cut down the tubing once it had been placed. The scrub technician cut the pediatric feeding tube into the appropriate length to be used as a shunt during the November 27, 2000, procedure. Respondent recalled that prior to this particular procedure, the tubing in question was not originally cut down to the appropriate size. It had to be cut down while in the operating room. It is during this cutting of the tubing that a tiny sliver, approximately two to three millimeters in length, was removed from the larger piece of tubing and entered the surgical field. Respondent did not know and did not have any way of knowing that the piece of tubing had entered the surgical field, as he was focused on preparing the artery itself for its incision while this tubing was cut. Respondent testified that the pediatric feeding tube in question was cut down to size before any incision was made in the carotid artery itself. Respondent performed the November 27, 2000, procedure as he normally does. After the procedure, Patient M.R. experienced extreme fluctuations in blood pressure. This can occur in patients due to multiple factors involving the nervous tissue and blood flow in the carotid artery, but there is no specific explanation for why it does happen. Subsequent to the November 27, 2000, procedure, Respondent monitored Patient M.R., addressing the extreme fluctuations in blood pressure along with the consulting physicians referred to above. Respondent noted that Patient M.R. developed a hematoma subsequent to the first procedure. He made a determination that the best course for Patient M.R. would be to evacuate the hematoma. In Respondent's opinion, evacuating the hematoma would speed up the healing process. Respondent performed this procedure on November 28, 2000. Patient M.R. tolerated this procedure well, and there was nothing remarkable about the procedure itself. Respondent palpated Patient M.R.'s artery during the course of this procedure and used the Doppler to reinforce his findings on palpation. A Doppler signal gives more specific information about the varied nature of blood flow in the internal and external carotid arteries. It was not Respondent's standard practice, nor is it necessary, to create a medical record that palpation of the artery has occurred, since it is such a basic and common occurrence that its notation on the record is not deemed to be necessary. Respondent continued to follow Patient M.R. subsequent to the November 28, 2000, procedure. When it was determined that Patient M.R. had suffered a stroke, Respondent was left with a choice of either doing nothing, or reopening the artery in an effort to save Patient M.R.'s life. Respondent chose to reopen the artery in an effort to determine whether anything could be done to save Patient M.R. Respondent opened the prior incision in the carotid artery on November 29, 2000, and inserted the Fogarty catheter in order to evacuate any debris that was located within the carotid artery. Respondent testified that it was at about this time that the piece of tubing was found; however, he further testified that he did not see the tubing in question come from the lumen of the carotid artery. Respondent's testimony is credible. It was Respondent's opinion testimony that the piece of tubing in question was located in the subcutaneous tissue outside of the artery. Its exact location within the various layers of subcutaneous tissue was not observed during the procedure. It was not possible for the piece of tubing in question to have entered the artery at this time. There was no evidence to suggest that the piece could have migrated into the artery at a later time. James Dennis, M.D., is a board-certified vascular surgeon who is the chief of the vascular surgery department at the University of Florida in Jacksonville, Florida. Dr. Dennis has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Dennis testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient M.R. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient M.R., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes. Dr. Dennis also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient M.R. Dr. Dennis' standard of care opinions were based on several factors. First, it was Dr. Dennis' opinion that based upon the contents of the chart, the only time that the piece of pediatric feeding tube could have entered Patient M.R. was during the course of the November 27, 2000, procedure. Dr. Dennis testified that in his opinion, Respondent deviated from the standard of care in allowing the piece of pediatric feeding tube to enter Patient M.R.'s body. This would be his opinion even if Respondent did not see the sliver of tubing in question enter Patient M.R.'s body and even if the piece of tubing in question were so small and translucent as to be practically invisible. Dr. Dennis also testified that in his opinion, Respondent deviated from the standard of care during the November 28, 2000, procedure in that he failed to adequately palpate the carotid artery. Dr. Dennis was critical of Respondent's use of a Doppler to assess Patient M.R.'s pulse. In Dr. Dennis' opinion, the use of the Doppler was indicative a weakening pulse rate and that the proper practice would have been to palpate the artery by touch rather than by using a Doppler instrument. Dr. Dennis was also critical of Respondent during the November 28, 2000, procedure for his failure to find the piece of tubing in question. It is Dr. Dennis' opinion that the piece of tubing had to have been located within the lumen of the artery and that had Respondent adequately palpated the entire length of the carotid artery during the November 28, 2000, procedure, he would have located the piece of tubing within the artery and could have taken appropriate steps to remove the piece of tubing before Patient M.R. suffered his stroke later that night or during the early morning hours of November 29, 2000. Dr. Dennis' opinion that the piece of tubing in question had to have been located in the lumen of the artery was also based upon his assessment of the procedures performed. He discounted the theory that the piece of tubing was located within subcutaneous tissue outside of the artery because, in his opinion, the piece of tubing would have been discovered either during the November 28, 2000, procedure or earlier in the November 29, 2000, procedure if it had been outside the artery. However, according to Dr. Dennis, based upon the timing of when the piece of tubing was found, the tubing itself had to have been located within the lumen of the artery until it was removed in the November 29, 2000, procedure. Dr. Dennis also rendered the opinion that not only was the piece of tubing located within the lumen of the carotid artery, but that the piece of tubing is directly related to the stroke which Patient M.R. suffered later that day or the following morning, which caused his death. Dr. Dennis testified that the piece of tubing became lodged in Patient M.R.'s carotid artery and that as blood flowed by it, platelets attached to the tubing, slowly building up with the carotid artery, until Patient M.R. experienced 100 percent stenosis in the right carotid artery, leading to his stroke. In sum, Dr. Dennis' opinion was that Respondent deviated from the standard of care by allowing a piece of tubing to enter Patient M.R.'s carotid artery and that it was this tubing which lead to Patient M.R.'s stroke and ultimately his death. This is in spite of the fact that Dr. Dennis was not able to state within any degree of medical probability how the sliver of tubing could have entered the artery. Dr. Dennis also rendered an opinion during his final hearing testimony that Respondent deviated from the standard of care because he did not secure the piece of tubing at issue in this case and see to it that the tubing was sent to the pathology laboratory at ORMC for analysis. Morris Kerstein, M.D., a board-certified vascular surgeon, reviewed all of the pertinent medical records reflecting the treatment and care Respondent provided to Patient M.R. Dr. Kerstein had been practicing for 35 years, and he is currently the chief of the vascular surgery department at the Veteran's Administration Hospital in Philadelphia, Pennsylvania. Dr. Kerstein has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Kerstein's opinion based upon his education, training, and experience is that Respondent did not deviate from the standard of care in his treatment of Patient M.R. First, Dr. Kerstein testified that in his opinion, Respondent's conduct during all three procedures at issue was appropriate. As to the November 27, 2000, procedure, there was no way for Respondent to be aware that the piece of pediatric feeding tube had entered the operative field. It was too small to be noticed, and it was of a translucent color which made locating it extremely difficult. He was not critical of Respondent for not cutting the tubing himself. He testified that if, in fact, the sliver of tubing entered the surgical area as a result of the scrub technician cutting the tubing, and a two to three millimeter fragment jettisoned into the surgical field, this would not constitute a deviation from the standard of care by Respondent. Dr. Kerstein testified that he felt the November 28, 2000, procedure was performed appropriately as well. He testified that it was not a deviation for Respondent to use a Doppler to feel for pulses in the arteries, and to the contrary, it reveals that Respondent was being meticulous beyond what the standard of care requires. He opined that Respondent certainly would have palpated the arteries in question, and to suggest otherwise based on the absence of a note to that effect is not an appropriate conclusion to draw. Dr. Kerstein rendered the opinion that he did not believe that the piece of tubing in question was located within the lumen of the artery of Patient M.R. He testified that there was no way for the tubing to enter the artery because the sliver in question came off of the longer tubing before an incision was made in the carotid artery. There is therefore no reasonable explanation as to how the piece in question could have entered the carotid artery in the first place. Dr. Kerstein also disputed the theory that not only was the piece of tubing located within the lumen of the artery, but also the piece in question actually caused Patient M.R.'s stroke. Dr. Kerstein relied principally on the radiographic studies. Both the CT Scan of the brain and the angiogram taken late in the evening of November 28, 2000, revealed a right posterior occipital infarct. The posterior of the brain is the back of the brain, and if the infarct was located there, it means that the cause of the stroke had to be something other than an occlusion in the carotid artery. This is because the arteries that feed the back portion of the brain are the basilar and vertebral arteries, not the carotid artery. Therefore, there could be no possible causal connection between the sliver in question and Patient M.R.'s stroke. Dr. Kerstein's opinion as to the cause of Patient M.R.'s stroke focused on his personal history rather than on the events of November 27, 2000. He noted that Patient M.R. presented with severe atherosclerotic changes, indicative of an advanced disease process. He noted that Patient M.R. suffered from chronic obstructive pulmonary disease, which was the product of his 54-year smoking history. He also noted Patient M.R.'s significant cerebrovascular disease. He also stated that thrombosis (or clotting of the blood) is a known complication of this procedure and can happen for several plausible reasons other than a sliver of tubing in the artery. All of these conditions conspired to predispose Patient M.R. to suffer a significant event such as the stroke he suffered on November 28 through 29, 2000. Dr. Kerstein also noted that the piece of tubing was completely inert, and given its size and its location in the subcutaneous tissue outside of the carotid artery, the tubing would have had no impact whatsoever on Patient M.R.'s prognosis. The tubing in question is an example of inert material that can remain inside the body, such as the case of a bullet which is located too close to the spinal cord to allow for an operation to remove it, without causing the body any harm. Dr. Kerstein had no criticism of the medical records Respondent kept regarding the treatment he provided to Patient M.R. He specifically noted that the records were accurate and honestly reflected what had occurred during the procedure. The fact that no foreign object was noted in the first two procedures was appropriate because at that point, he had no reason to suspect the presence of a foreign object. The lack of reference to a cause of Patient M.R.'s atypical post-operative course was appropriate because in fact Respondent could not have defined a single reason why Patient M.R. was reacting the way he did. Finally, the operative note from the November 29, 2000, procedure was appropriate, as it also honestly and accurately depicted what had occurred; he made a specific comment on Respondent's note that the sliver was not indeed from the lumen, but that the exact location was unclear, finding this to be an unambiguous statement of fact. Dr. Kerstein also disagreed with the state's position with regard to the responsibility for maintaining possession of the piece of tubing post-operatively. Dr. Kerstein testified that it was the responsibility of the circulating nurse, an employee of the hospital, to arrange for the piece of tubing to be sent to the pathology lab for examination. The evidence is insufficient to support Petitioner's contention that the pediatric feeding tube sliver at issue caused Patient M.R. to suffer a stroke because of its location within the carotid artery itself. Radiographic studies were performed on Patient M.R. after the stroke. A CT Scan performed on November 28, 2000, revealed an acute right posterior cerebral artery distribution infarct. Further, a cerebral angiogram was performed on November 28, 2000, and revealed "markedly diseased circulation particularly in the right vertebral and basilar arteries." This note also revealed: "Severely diseased posterior fossa circulation." Based upon the location of the infarct in Patient M.R.'s brain, the cause of the stroke had to have been either the vertebral or basilar arteries that supply blood to the posterior part of the brain. In view of all the evidence, the expert testimony of Dr. Kerstein, together with that of Dr. Horowitz, was more persuasive than that of Dr. Dennis in regard to the standard of care and Respondent's actions in this matter.
Recommendation Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated either Subsections 458.331(t) or (m), Florida Statutes, in his treatment of Patient M.R. and that the Administrative Complaint be dismissed. DONE AND ENTERED this 9th day of June, 2003, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2003. COPIES FURNISHED: Michael D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. 390 North Orange Avenue Suite 1000 Orlando, Florida 32802 Daniel Lake, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Application Process Humhosco is a wholly owned subsidiary of Humana, Inc. Humhosco owns Humana Hospital Brandon and other hospitals in Florida. The record does not disclose thee number of such hospitals or whether Humhosco owns other assets. On February 26, 1988, Humhosco submitted to HRS a letter of intent to apply for a certificate of need for open heart services at Humana Hospital Brandon. The letter of intent included a certificate dated February 26, 1988, authorizing Humhosco to file the application for the project estimated to cost nearly $2 million, making available "sufficient funds" for the project, certifying that Humhosco shall accomplish the project within the time allowable by law at or below the costs stated in the application, and certifying that Humhosco shall license and operate the facility. The certificate was signed by Alice F. Newton, as Secretary of Humana, Inc. She certified that the representations contained in the preceding paragraph were resolutions of the Board of Directors of Humana, Inc. approved on February 26, 1989. On or about March 14, 1988, Humhosco submitted to HRS an application for a certificate of need to install and operate an open heart center at Humana Hospital Brandon. The projected cost was about $1.9 million. The application included a certificate dated March 16, 1988, containing resolutions similar to those contained in the certificate of February 26, 1988. The certificate was again signed by Alice F. Newton, but this time in her capacity as Secretary of Humhosco. The resolutions, which were dated as of March 16, 1988, were adopted by the Board of Directors of Humhosco. The application contained no financial statement of Humhosco. Instead, the application contained an audited financial statement for "Humana Hospital- Brandon (a division of Humhosco, Inc., a wholly-owned subsidiary of Humana Inc.)." The financial statement, which was for fiscal year ending August 31, 1987, reflected an examination of the financial records of Humana Hospital Brandon, not Humhosco. The financial statement disclosed a shareholder's equity of about $24 million and net income of about $6.2 million based on net revenues of about $47 million and income before income taxes of about $12.2 million. The record does not explain the basis for a shareholder's equity in a division of the corporation in which it owns shares. However, nothing in the record suggests that the financial statement is mislabelled. The financial statement appears to reflect the operations and net worth of a division of Humhosco, not Humhosco itself. The financial statement is of little value in assessing the financial condition of Humhosco. Nothing in the record supports an inference that Humhosco's other hospitals, as well as any other operating assets that Humhosco might own, are profitable or, if unprofitable, whether their losses are exceeded by the profits of Humana Hospital Brandon. By letter dated April 14, 1988, HRS requested additional information from Humhosco. The letter requested, among other things, a financial statement for the prior year and an original certificate rather than a copy. HRS never commented on the fact that the certificate accompanying the letter of intent evidenced resolutions from the corporate parent of the applicant or that the financial statements were of a division of the applicant. By letter dated May 12, 1988, Humhosco responded to the above- described omissions letter. In its response, Humhosco provided the earlier financial statement, which was for Humana Hospital Brandon and not Humhosco. The letter did not include any material information regarding either certificate. By letter dated July 11, 1988, HRS informed Humhosco of its intent to issue Certificate of Need 5537 for the establishment of the open heart program described in the application. The accompanying State Agency Action Report, which was dated July 8, 1988, recommended that the certificate of need be issued in its entirety. The report stated that the need methodology described by Rule 10-5.011(1)(f) justified seven open heart programs in District VI, which has only six such programs, and the Humhosco proposal was in substantial compliance with all criteria. The Hospital Humana Hospital Brandon is a 220-bed general hospital in Brandon, which is in eastern Hillsborough County. Humana Hospital Brand on is fully accredited by the Joint Commission of the Accreditation of Health Care Organizations. The hospital, which is a Level II trauma center with eastern Hillsborough County as its catchment area, contains 16 intensive-care and cardiac-care beds and 35 progressive-care beds, in addition to its regular medical-surgery beds. The hospital offers a wide range of services, including medicine, pathology, anesthesiology, radiology, neurology, intensive care, and emergency care available at all times for cardiac emergencies. The hospital provides cardiac catheterization services through its cardiac catheterization lab and noninvasive cardiographics lab. Open heart surgery is cardiac surgery during which a cardiopulmonary bypass procedure is used. Cardiac catheterization is a diagnostic/therapeutic procedure used in connection with heart and circulatory conditions. Coronary angioplasty is the expansion of narrowed segments of the coronary vessels. The proposed open heart suite would be adjacent to the existing cardiac catheterization lab, and the two facilities would share the same recovery/support area. The proposed program would provide a wide range of procedures, including the repair or replacement of heart valves, repair of congenital heart defects, cardiac revascularization, repair or reconstruction of intrathoracic vessels, and the treatment of cardiac truama. The program would have the ability to implement and apply circulatory assist devices such as the intra- aortic balloon assist and prolonged cardiopulmonary partial bypass. Need District and State Health Plans The 1985 District VI Health Plan reports that most cardiac surgeries are open heart with the most common of these being coronary bypass surgery. The plan acknowledges that an important use of cardiac catheterization is evaluation for open heart surgery. According to the plan, open heart surgery, particularly coronary bypass surgery, has been controversial with respect to its risk- and cost- effectiveness and the fairness of its distribution among the entire population. Noting a decline in procedures in District VI from 1983 to 1984, the plan concluded that the application of the present rule methodology could exaggerate need if the decline continued. Otherwise, however, the proposed program satisfied the policies of the district plan broadly relating to need. The State Health Plan stated that an inverse relationship exists between the volume of open heart procedures and surgical death rates. The state plan added, however, that no clear agreement exists as to the minimum number of procedures necessary to maintain staff skills. The plan endorsed the rule requiring that a new program project a minimum of 200 procedures annually within three years of opening. The State Health Plan reported the controversy concerning the efficacy of open heart procedures, at least at their current rate. The plan concluded that further study would be required before the issue could be resolved. The plan stated that new types of cardiac catheterization procedures may replace some open heart surgery, "while necessitating the availability of open heart programs on standby basis within the same facility." The plan also anticipated a reduction in the rate of open heart surgery with the introduction of new procedures, such as balloon angioplasty, clot-dissolving substances, and calcium blockers. The plan noted the recommendations of two groups that cardiac catheterization laboratories be located only in facilities providing open heart surgery. The plan suggested that catheterization laboratories without connected open heart programs would suffer lower utilization rates than catheterization laboratories with open heart programs. The State Health Plan concluded by establishing an objective "to maintain an average of 350 open heart surgery procedures per program in each district through 1990." HRS Rules Rule 10-5.011(1)(f), Florida Administrative Code, sets forth the HRS numeric need methodology. Rule 10-5.011(1)(f)8 provides a formula to estimate the number of open heart procedures for the horizon year, which, in this case, is 1990. Rule 10-5.011(1)(f)11 prohibits the approval of new open heart programs unless certain conditions are met, including satisfying the requirement of Rule 10-5.011(1)(f)5.d that 200 procedures annually be performed within three years after commencement of the service. The proposed open heart program would generate a minimum of 200 adult open heart procedures annually within three years after commencement. Ultimately, the program could handle as many as 500 procedures annually. Under the formula contained in Rule 10-5.011(1)(f)8, the estimated number of open heart procedures in District VI is 2555 in 1990, which is when the proposed program would become operational. The projected population of District VI on January 1, 1990, is 1,563,354 persons. For the 12-month period ending two months prior to the deadline for letters of intent for the subject batching cycle, the use rate per 100,000 persons in District VI was 163.45. This figure is based on a population of 1,469,572 persons residing in District VI as of July 1, 1987, and 2402 open heart procedures performed during calendar year 1987. (The number of procedures includes 1050 procedures performed at Tampa General for the one-year period ending September 30, 1987, rather than calendar year 1987.) Rule 10-5.001(1)(f)11.b requires that the projected number of procedures in 1990 be divided by 350 in order to generate the number of programs needed to exist in 1990. The result of this calculation is that seven open heart programs are needed in District VI. That means that there is a net need for one program because there are presently six existing and approved open heart programs in District VI. However, Rule 10-5.011(1)(f)11.a.I prohibits the approval of any new open heart programs unless "each existing and approved" program is "operating at" and "expected to continue to operate at" a minimum of 350 adult open heart cases annually. The meaning of this rule is unclear, and HRS apparently interprets it merely to require that all existing programs average 350 procedures annually at the time of determination of the actual use rate. Another interpretation of the rule is that each existing and each approved program must be operating at the requisite rate before new programs could be approved. This interpretation is impractical because approved programs that are not yet in operation are not operating at any rate. If the intent of the rule were to prohibit the establishment of more than one open heart program at a time, HRS could have simply stated as much. The most likely interpretation is one that addresses the universally recognized relationship between volume of open heart procedures (up to a certain level) and patient mortality. The rule requires that each existing and approved facility in the district be operating at 350 procedures annually before new open heart programs are licensed. The rule does not authorize averaging the total number of procedures among the licensed facilities in a district. The inverse relationship between the number of procedures and surgical deaths is not dependent upon an average number of procedures performed in a geographical area. The safety of an open heart patient is dependent upon the actual number of open heart procedures being performed at the hospital that he or she has selected for open heart surgery. The presence in District VI of a hospital performing 1400 open heart procedures annually is of no relevance to the patient who has unwittingly selected a hospital in the same district that performs only, say, 50 such procedures annually. The six existing and approved open heart programs in District VI are identified below by facility, location, and numbers of procedures in 1987 and the first six months of 1988. Facility County 1987/1988 Procedures Tampa General Hillsborough 1050/714 St. Joseph's Hillsborough 887/514 University Community Hillsborough 0/0 Manatee Memorial Manatee 0/70 L. W. Blake Manatee 0/0 Lakeland Regional Polk 465/292 TOTAL DISTRICT VI PROCEDURES--1987 2402/1590 The 1988 procedures for Manatee Memorial cover the period of February, when the program became operational, through June. The State Agency Action Report indicates that Manatee Memorial is an approved but not yet existing program, although the program had already accounted for 70 procedures by the time of the report. The reason for this apparent discrepancy is that HRS uses the 1987 data used for calculating the use rate when determining the status of other programs. HRS offered little explanation of why it used 1987 data for determining in 1988 whether other programs were existing. Rule 10-5.011(1)(f), Florida Administrative Code, which covers open heart programs, does not define "approved and existing programs" or establish the time at which the status of a program should be determined. However, given the critical role of patient safety in the licensing process, the rule does not justify the reference to obsolete data. The Manatee Memorial open heart program was existing and approved at the time of the letter of intent and application of Humhosco and the State Agency Action Report. It was not then operating at 350 open heart procedures annually. Its approximate annualized rate of 168 procedures is materially below even the annual rate of 200 procedures often cited as the minimum number at which the mortality rate levels out. Additionally, there was no evidence that Manatee Memorial would attain such a volume of open heart procedures. Conclusions Regarding Need According to the numeric need methodology, exclusive of Rule 10- 5.011(1)(f)11.a.I, District VI could support an additional open heart program. Although in the long run the rate of open heart procedures may decrease for the reasons set forth above, the rate of such procedures will probably increase at least through 1990 and probably several years thereafter. For reasons set forth elsewhere in this recommended order, the Humana Hospital Brandon program would successfully satisfy this need. However, the requirement of Rule 10-5.011(1)(f)11.a.I has not been met, and thus need under the rule does not exist. Of the six current open heart programs in District VI, three performed no procedures in 1987. During the first six months of 1988, one of these three programs became operational, but the other two had yet to perform their first procedure. Although the first-year rate of procedures at Manatee Memorial was not insubstantial, the program is not operating at and expected to continue to operate at the minimum annual rate of 350 procedures set forth in the rule. The likelihood of the Manatee Memorial program attaining such a rate is especially difficult to predict in view of the unknown consequences of the initiation of another open heart program in Manatee County and another elsewhere in District VI. On balance, the proposed program at Humana Hospital Brandon is not needed or authorized due to the existing volume of procedures at Manatee Memorial as of the time of the application and approval and the adverse effect of reduced volumes upon patient safety. Rule 10-5.011(1)(f)11.a.I makes it clear that District VI needs time to absorb the recently approved open heart programs before a new one should be established. Quality of Care Humhosco has the ability to provide high quality of care and has done so in the past. An open heart program at Humana Hospital Brandon would improve the quality of care at the hospital. The new program would have limited effect upon the hospital's trauma services due to the limited number of trauma-related open heart procedures. However, the new program would complement the cardiac catheterization lab at the hospital. The addition of an open heart program would permit Humhosco to add cardiac angioplasty services in the cardiac catheterization lab at the hospital. Continuity of care and patient safety and convenience would be enhanced by the establishment of an open heart program at Humana Hospital Brandon. Strong physician support exists for an open heart program at Humana Hospital Brandon. Many existing staff persons already have the necessary skills and experience to participate in the open heart program. The staff includes 10 cardiovascular surgeons certified by the Medical Board of Thoracic Surgery or board-eligible for certification and three board-certified or board-eligible anesthesiologists trained in open heart surgery. Humhosco would add the additional staff needed to operate the proposed program. Humana Hospital Brandon has the capacity to accommodate the projected patient volume from the open heart program. Service Accessiblity Rule 10-5.011(1)(f)4.a provides that open heart programs shall be available within a maximum automobile travel time of two hours under average conditions for at least 90% of the district's population. The two-hour standard reflects the fact that open heart surgery is a tertiary service that is ordinarily performed on a scheduled rather than emergency basis. Hillsborough County is the largest county within District VI. The growth rate of eastern Hillsborough is higher than the growth rate of the remainder of the county. No open heart program is presently located in eastern Hillsborough County. A program at Humana Hospital Brandon would reduce the travel time for the persons living in eastern Hillsborough County. However, the two-hour standard is presently met in District VI, and the improvement in geographical access resulting from the establishment of a program at Humana Hospital Brandon is not substantial. The proposed program would satisfy the requirements of Rule 10- 5.011(1)(f)4.b and c regarding hours of operation and waiting periods. Humhosco has projected for the open heart program a payor mix of 55% Medicare, 2% Medicaid, and 5% indigent. If these projections were realized, Humhosco would achieve the objective of making open heart surgery available to these classifications of patients. Humhosco's record of serving these patient classifications at Humana Hospital Brandon suggests that these projected goals would be achieved. Financial Feasibility The immediate financial feasibility of the proposed project is good. The source of construction funds is a reasonable mix of 25% equity and 75% debt. The borrowed funds will come from Humana, Inc., which has ample resources to make a loan of this magnitude. The terms are 10 years at 12% with 120 equal monthly payments of $20,575.89 principal and interest. The availability of the equity portion of construction costs, which amounts to a little over $475,000, is uncertain due to the lack of information concerning the financial condition of the applicant. It is unlikely, however, that the unavailability of any or all of these funds would interfere with the project. Humana, Inc. has in any event committed by resolution to make available to the applicant sufficient funds to accomplish the project. The long-term financial feasibility of the proposed project is good. Even after total interest payments of about $168,000 and $158,000 in the first two years of operation, Humhosco projects, based on reasonable assumptions, that the open heart program would produce after-tax income of about $250,000 on first-year gross revenues of about $6.2 million and $345,000 on second-year gross revenues of about $7 million. Cost Effectiveness The implementation of an open heart program at Humana Hospital Brandon would encourage competition among health care providers of open heart services. Humhosco projects the average charge per open heart admission when the program would open in 1990 to be $29,000. This figure is about $3600 less than the average charge per open heart admission at Tampa General in 1987 and compares favorably with the charges of other providers in the area. In the long term, the effect of an open heart program at Humana Hospital Brandon could have an adverse effect on cost effectiveness if the program at Tampa General lost substantial volume due to the presence of this competition. Tampa General is a major provider of medical services to the medically indigent. Although publicly supported, Tampa General expends more on indigent-related costs than it receives in public funds for the medically indigent. Tampa General therefore must subsidize its unreimbursed indigent services with revenues from paying patients. In 1980, after a period of serious financial strains, Tampa General commenced a modernization program to attract paying patients. The program, together with a $160 million bond issue and new marketing efforts, has significantly improved the financial condition of the hospital. The approval in the past of new open heart programs in the area has coincided with the reduction of open heart procedures at Tampa General. In fiscal year ending 1983, Tampa General performed 1671 procedures. The following year, during which St. Joseph's began performing open heart surgery, Tampa General performed 878 procedures. In fiscal year ending 1985, Tampa General performed 802 procedures. The following two years, during which no new programs became operational, Tampa General performed 1050 and 1428 (projected) procedures, respectively. Undoubtedly, a new open heart program at Humana Hospital Brandon would have some effect on existing programs, including that at Tampa General. However, the record does not support a finding that the establishment of an open heart program at Humana Hospital Brandon would have a more lasting effect upon the program at Tampa General than did the other programs established in recent years. Other Factors The record does not demonstrate that there are less costly, more efficient, or more appropriate alternatives to the in-patient services proposed in the subject application. With one exception, existing in-patient facilities providing open heart services are being used in an appropriate and efficient manner. The exception is that there is nothing in the record to suggest that the open heart programs at Manatee Memorial, University Community, and L. W. Blake are being utilized efficiently. To the contrary, the only program in existence at the time of the application was not operating at the optimal minimum level. The costs and methods of proposed construction are reasonable and appropriate. There is nothing in the record to suggest that practical alternatives exist to the construction program contemplated by Humhosco. Open heart patients will not experience serious problems in obtaining in-patient care if the proposed application is not approved. There is nothing in the record to suggest that joint, cooperative, or shared resources could be used to provide the open heart services for which Humhosco has applied. The proposed program would not have any significant effect on research and educational facilities or health professional training programs.
Recommendation Based on the foregoing, it is RECOMMENDED that a Final Order be entered dismissing the petition of University Community Hospital in Case No. 88-4366 on the grounds that it dismissed its petition, and denying the application of Humhosco for Certificate of Need 5537. DONE and ENTERED this 18th day of April, 1989, in Tallahassee, Florida. ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of April, 1989. APPENDIX Treatment Accorded proposed Findings of Humhosco and HRS 1-29. Adopted or adopted in substance. 30. Rejected as against greater weight of the evidence to the extent that the requirement of 350 procedures at each facility is part of the numeric need methodology. 31 and 33. Adopted in substance. However, the resulting determination of need or no need is tentative. Rule 10-5.011(1)(f)11 provides a general prohibition against the establishment of programs under normal circumstances even though, under the other portions of the rules, there would otherwise be a numeric need. 32. Adopted. Rejected as legal argument. To the extent factual, rejected as against the greater weight of the evidence. Adopted in substance. Rejected as unnecessary. 37-38. Rejected as subordinate. Adopted in substance at least as to the maintenance or slight increase of the present use rate for the immediate future. This fact does not justify a deviation from the rule requirement of the historic use rate, which in any event would justify another program. Nor does this fact justify a not normal condition for the reasons set forth in the recommended order. It should be noted that Humhosco did not offer evidence to this effect at the hearing for either of these improper purposes. This fact is only relevant in assessing the impact of the establishment of the proposed project upon existing providers, especially Tampa General and, to a lesser extent due to the greater amount of speculation involved, the new providers such as Manatee Memorial. Rejected as unsupported by the greater weight of the evidence. An increase in the number of programs has historically been accompanied by an increase in the number of procedures. It is conjecture whether or to what degree the addition of programs caused such an increase. 41-45. Adopted in substance. 46-48. Rejected as subordinate. 49-52. Adopted or adopted in substance. 53-55 and 60. Rejected as legal argument. 56-58 and 61. Adopted or adopted in substance. 59. Rejected as recitation of evidence. 62-64. Rejected as subordinate. 65. Rejected as legal argument. 66-69. Adopted. 70 and 72. Rejected as unsupported by the greater weight of the evidence. 71. Rejected as irrelevant. 73-76. Rejected as subordinate. Concerning the "overcrowded" conditions at Tampa General, the evidence showed only that the Tampa General program was, at times, quite busy, but not overutilized. The periodic high level activity at Tampa General is subordinate to the findings in the recommended order concerning the limited impact upon Tampa General of the approval of the proposed project. 77. Adopted in substance. 78-82. Rejected as subordinate. 83. Adopted in substance. 84-86. Rejected -as subordinate. Rejected as unsupported by the greater weight of the evidence. The proposed payor mix is reasonable insofar as providing access to the medically indigent and Medicaid patients. The record is unclear, however, that the approval of the application would improve the existing access of such patients to open heart services. Adopted in substance. 89 and 91. Rejected as subordinate. 90. Adopted, except that the last sentence is rejected to the extent that it suggests that Humhosco's commitment to financial access is greater than the commitment of existing providers. 92-94. Adopted. 95-96. Rejected as irrelevant. A hospital has no financial strength. A lender or investor assesses the legal entity that owns or operates the hospital. The net worth and profitability of the hospital may have a material impact on the net worth and profitability of the owner or operator of the hospital. However, it is impossible to make that determination without assessing the assets, liabilities, profits, and losses of the legal entity and not simply one of its assets. The immediate financial feasibility may be inferred by the activity of Humana, Inc. with respect to the proposed project. Rejected as legal argument. Adopted in substance. 99-100 and 108. Adopted. 101-107. Rejected as subordinate and cumulative. 109 and 123. Rejected as legal argument. 111-122. Adopted in substance. 123. Rejected as legal argument. and 126. Adopted. and 127-128. Rejected as subordinate. Adopted in substance. Rejected as cumulative. 131-133. Rejected as cumulative and, for the purpose offered, irrelevant. 134-137. Adopted in substance. 138-150. Rejected as subordinate. Treatment of Proposed Findings of Tampa General 1-3. Adopted. Rejected as legal argument and, as to the policy of HRS, irrelevant insofar as such policy might deviate from the clear requirements of the statute. First two sentence rejected as legal argument. Remainder adopted. 6-7. Rejected as legal argument except that last sentence of Paragraph 7 is adopted. First two sentences adopted. Remainder rejected as irrelevant. Adopted in substance. 10-11. Adopted. 12. Rejected as legal argument and, to the extent factual, against the greater weight of the evidence. 13-14. Adopted in substance. 15-16. Rejected as unnecessary. 17. Rejected as against the greater weight of the evidence. 18-20. Adopted in substance. Adopted insofar as Humhosco provides quality cardiac care services at Humana Hospital Brandon without an open heart program. Remainder rejected as against the greater weight of the evidence. Rejected insofar as the proposed finding suggests that a slight improvement in geographic accessibility should, as a matter of law, be ignored in this case. Adopted in substance if, like the proposed finding in Paragraph 19 concerning trauma-center status, this proposed finding means only that the slight improvement in geographic accessibility is alone insufficient to justify granting the certificate of need. Rejected as subordinate. 24-25. Rejected as recitation of evidence and subordinate. Rejected as unsupported by the greater weight of the evidence. Adopted. 28-29. Adopted in substance. Rejected as irrelevant given the interpretation adopted in the recommended order concerning the meaning of Rule 10-5.011(1)(f)11.a.I. Adopted in substance. 32-33. Rejected as unsupported by the greater weight of the evidence. 34. Rejected as subordinate. 35-40. Rejected as unsupported by the greater weight of the evidence. 41-42. Rejected as unsupported by the greater weight of the evidence and subordinate. Treatment Accorded proposed Findings of St. Joseph's 1-4. Adopted or adopted in substance. First sentence adopted except that the tax status of Humhosco as a "holding company" is rejected as a legal conclusion, irrelevant, and unsupported by the greater weight of the evidence. Second sentence adopted. Third sentence rejected as irrelevant. Third sentence rejected as a legal conclusion, irrelevant, and unsupported by the greater weight of the evidence, although it appears to be true that the identities of the persons occupying the named positions are the same between the two companies. Last sentence rejected as irrelevant. Adopted. Rejected as irrelevant. Adopted. Rejected as irrelevant. 10-13. Rejected as legal argument and unnecessary, given the finding in the recommended order that, even ignoring the additional beds that have been approved at Humana Hospital Brandon, the hospital is not overutilized. 14-15 and 17 and 19. Rejected as legal argument. 16. Rejected as subordinate. 18. Adopted in part and rejected in part. The existence of a cardiac catheterization lab does not mandate the authorization of an open heart program. However, the record in this case supports the finding that the addition of an open heart program would complement existing services in the cardiac catheterization lab, and nothing in the law prohibits the consideration of such a factor. 20-21. Rejected as irrelevant. See Paragraph 18 above. Rejected as irrelevant. Rejected as legal argument. Rejected as unsupported by the evidence. 25-26. Rejected as subordinate to the finding contained in the recommended order that the status as a trauma center is not a significant factor in considering the subject application. 27-28. Rejected as legal argument. 29-30. Adopted in substance. 31-33. Rejected as recitation of evidence. 34. Rejected as against the greater weight of the evidence. 35-39. Rejected as subordinate. 40. Adopted in substance. 41-49. Rejected as subordinate. 50. Rejected as irrelevant. 51-52. Rejected as against the greater weight of the evidence. 53-55. Rejected as subordinate. 56. Rejected as legal argument. 57-58. Rejected as recitation of testimony. Rejected as legal argument. Adopted. 61-69. Rejected as unnecessary. Rejected as legal argument. Adopted except that the last sentence is rejected as legal argument. Rejected as legal argument. Rejected as recitation of testimony. Rejected as legal argument. Adopted in substance. 76-78. Rejected as recitation of evidence. COPIES FURNISHED: Ivan Wood, Esquire Sam Power Wood, Lucksinger & Epstein Clerk Four Houston Center Department of Health and 1221 Lamar, Suite 1440 Rehabilitative Services Houston, TX 77010 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Radey, Esquire Elizabeth McArthur, Esquire Gregory L. Coler Aurell, Fons, Radey & Hinkle Secretary Post Office Drawer 11307 Department of Health and Tallahassee, FL 32302 Rehabilitative Services Tallahassee, FL 32399-0700 Cynthia S. Tunnicliff, Esquire Carlton, Fields, Ward, Emmanuel, Smith & Cutler, P.A. John Miller Drawer 190 General Counsel Tallahassee, FL 32302 Department of Health and Rehabilitative Services 1323 Winewood Boulevard John Rodriguez, Esquire Tallahassee, FL 32399-0700 Assistant General Counsel 2727 Mahan Drive Fort Knox Executive Center Tallahassee, FL 32308 James C. Hauser, Esquire Joy Thomas, Esquire Messer, Vickers, Caparello, French and Madsen, P.A. Post Office Box 1876 Tallahassee, FL 32302 =================================================================
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.
The Issue Whether Respondent, in treating Patient #1 in 1987, failed to practice medicine with that level of care, skill, and treatment which a reasonably similar physician recognizes as acceptable under similar conditions and circumstances; and whether Respondent failed to keep written medical records justifying the course of treatment of Patient #1.
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. Respondent graduated from the University of Tehran in 1961; interned at Grace Hospital in Detroit, Michigan, in 1961-62; took Residency in Internal Medicine in 1962-65; and a Fellowship in Cardiology in 1965-67, the latter two in Detroit hospitals. He is not board- certified in Cardiology. Patient #1 (hereinafter designated as "Patient") was referred to Respondent by Dr. Barker, the company physician for General Electric Company in Largo, Florida, where Patient was employed on July 23, 1976. Patient's chief complaint was a recent weight gain, tiredness, headaches and high blood pressure. Following a physician examination of the patient, the impression of hypertension was recorded (Exhibit 2), laboratory tests were performed which included a thyroid profile; and Hydrodiruil, 50 mg., was prescribed. At a second visit one week later (July 30) Hypothyroidism was documented, a thyroid scan was ordered and Patient was told to return in one week. Patient was thereafter seen by Respondent on August 10, 1976; September 7, 1976; October 12, 1976; January, March, July and October 1977; January, April, June and November 1978; February, May and December 1979; March, June and September 1980; January, April, July and October 1981; January, April, July, September, October, November and December 1982; February, March, April, May, August, September, October, November and December 1983; January, March, April (3), June, August and November 1984; February, May, August and November, 1985; February, April, May, June, July and October 1986; January, February and March (2), 1987. In January 1982 Patient reported pain in the right shoulder and neck region. In July he reported chest pain and was prescribed nitroglycerin. In November he again reported three to five minute chest pains. No significant changes were reported in 1983. Patient was taking Synthroid daily during this period. Although not reported in doctor's notes, on December 4, 1984, a routine electrocardiogram reviewed by Dr. Paul Phillips was reported as abnormal (Exhibit 2, page 72). On the May 13, 1986, visit, a stress test was ordered for Patient which was administered 5/21/86. The test was stopped after 6.2 minutes because the exercise resulted in leg fatigue and shortness of breath. The report (Exhibit 2, page 55) shows: I. Limited aerobic capacity; II. Normal resting and exercise EKG, and III. No detectable symptomatic ischemic heart disease. A subsequent EKG taken January 7, 1987, viewed by the same doctor, was reported as abnormal (Exhibit 2, page 26). The January 15, 1987 entry in Exhibit 2 states EKG with no change. No additional tests were ordered. During the period after January 1987, the patient began experiencing more chest pains and inability to withstand exertion, although Respondent's notes for the February 23, 1987, visit states "EKG normal, walks three miles a day with no problem in the past two weeks." This information can only have come from the patient and tends to refute the patient's wife's testimony that Patient was experiencing severe chest pains in February 1987. On the other hand, the wife testified that in February 1987 they visited a son in Atlanta, Georgia, and the patient and his son went to the park to exercise. The first day the patient walked briskly without discomfort, but his pulse did not rise. The following day when he attempted the same walk, the pain was so severe he could not walk. On March 2, 1982, as noted in Exhibit 2, Patient still complained of lower sternal discomfort. An echocardiogram was ordered which, as best I can read the handwritten notes (Exhibit 2, page 40) indicates normal findings. Patient returned to Respondent's office on March 10, 1987, complaining of chest pains on and off. Procordia was ordered, and Patient was directed to return in one week. On March 11, 1987, Patient went to work as usual. When he didn't telephone his wife to say he had arrived safely, the wife called the patient who reported he had great difficulty walking from his parked car to the office and that he was in a lot of pain. On March 12, 1987, Patient did not go to work. Sometime that morning, either Patient or his wife telephoned Respondent but were unable to reach him. Word was left for Respondent to call. The call from Respondent came around 10 p.m., March 12, and Patient was advised to go to the hospital. Patient was admitted to the emergency room at Humana Hospital, St. Petersburg, Florida, at 11:53 p.m., March 12, 1987, after arriving at 10:45 p.m. On March 13, 1987, Patient had occasional chest pains and cardiac enzymes were elevated. He was medicated with Inderal, Isurdil, Xanax, Morphine and Zantac. The hospital medication chart (Exhibit 3, page 15) shows Patient was administered Nitroglycerine at 0330, 0805 and 1830; that he was administered Morphine Sulphate at 0923 and 1530; Demoral at 0810; Lasix at 1930; and Heparin at 1940. Exhibit 3 on page 16 indicates Patient received Inogral, Isordil, Maalox, Zomax, Zantac and Tigen, but does not indicate when. Exhibit 3, Page 17 indicates Patient received D5W, Dopamine, Heparin, Lanoxin and Varapimal on March 13, 1987. The patient remained in the Emergency Room until 2030, March 13, due to no bed available. He apparently suffered a massive heart attack around 7:45 p.m. while in the Emergency Room. Nurses notes for March 13, 1987, indicates Patient was sleeping during the early morning hours, was given Nitroglycerine at 0330 for chest pain and Morphine Sulphate at 0400; at 0730. Patient appeared in no discomfort; at 0805. Patient complained of pressure sensation in midsternal area and was medicated with Nitroglycerine but continued to complain of chest discomfort and was given Demoral; at 0930 Patient complained of heart burn after eating breakfast relieved with burping; at 1010 Patient complained of slight chest pressure, given Nitroglycerine; seen by Respondent and wife at 1045 and 1400; 1530 complained of pain and was given Morphine Sulphate; 1815 vomited two basins full; 1830 Patient sweating profusely (diaphoretic), given Nitroglycerine, and at 1845 Morphine Sulphate for chest pain and discomfort; at 1850 an emergency EKG was done and Respondent was paged; at 1905 EKG reviewed and Dopamine drip began; at 1920 Dopamine drip increased 10 cc.; 1930 Lasix administered; 1940 Heparine administered, 7500 units IVP; 2000 Dopamine increased to 15 cc.; 2015 Lanoxin given and Dopamine increased to 25 cc.; 2030 patient vomited approximately 500 cc. reddish fluid; 2035 Verapamil given; 2110 Lanoxin 25 mg. repeated and Dopamine increased to 35 cc.; 2125 patient extremely restless, respiration labored - Valium and Atropine given; and code called. Discharge summary shows that at 1945 Patient developed acute respiratory distress, profuse perspiration and no chest pain. The patient was intubated, subclavian catheter was inserted in the right atrium, Patient was given full CPR, Epinephrine injection and intravenous bicarbonate. Patient expired at 2219. Petitioner's expert witness opined that prior to January 1987 Respondent's treatment of the patient met the prescribed standard of care for physicians, but subsequent thereto it did not. This opinion is predicated upon the worsening of Patient's condition in January, February and March 1987. Although there was an abnormal EKG in 1984, no evidence was presented that this EKG changed when subsequent EKGs were taken. Respondent's notes state no change in the EKGs taken through January 15, 1987. The entry made January 15, 1987, specifically found no change in EKG. Abnormal EKGs were reported in 1984 and on January 7, 1987. No evidence was presented to contradict the July 15, 1987, entry that there was no change in the EKG. The increase in cardiac enzymes found March 13, 1987, is evidence that damage to the heart muscle had occurred. Petitioner's expert faults Respondent for not ordering an angiogram at this time to determine the condition of the blood vessels to and from the patient's heart. Despite the fact that Patient was at Humana Hospital which did not have a cardio-cath lab, Petitioner's expert opined that the patient should have been transferred to a tertiary care hospital in the area with such facilities. Respondent, on the other hand, contends that invasive procedures at that time would have been fatal to this patient. In his testimony Respondent opined that the patient had chronic stable angina before he was even forty. Further, that the patient fit in the category of the population with a single coronary artery disease that have a malignant course; that this patient, who had this type of artery disease, was foredoomed to die, and nothing could have saved him, and that any invasive procedure would have resulted in the death of the patient. Respondent contends that the autopsy report confirms this opinion. Despite this testimony a majority of the publications presented by Respondent as late-filed exhibits contained discussions regarding the treatment of patients with unstable angina. Petitioner's expert witness opined that the rapidly deterioration of the patient on March 11, 1992, clearly demonstrated the patient needed to be hospitalized and invasive procedures initiated to determine the condition of the patient's arteries. It is the failure to initiate such procedures that rendered the treatment of this patient below the minimum acceptable standards of treatment recognized by a reasonably prudent similar physician as being acceptable under similar circumstances and conditions. Petitioner's witness further opined that the physician's records regarding this patient were insufficient to justify the course of treatment of the patient. This opinion was based upon the fact he found Respondent's records "rather limited, often almost illegible, and did not really reflect the collection of subjective and objective data that could lead one then to follow the process of evaluation and management of either gastrointestinal problems or cardiac problems." He further concluded that these records did not reflect a cardiac diagnosis of the patient.
Recommendation It is recommended that a Final Order be entered finding Si H. Azar guilty of violation of Section 458.331(t) and not guilty of violating Section 458.331(1)(m), Florida Statutes; that he be placed on probation for a period of three years under such terms and conditions as the Board of Medicine deems appropriate; and that he be required to take additional continuing education courses in the use of invasive procedures and in diagnosis and treatment of cardiac patients. ENTERED this 2nd day of, July 1992, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of July, 1992. COPIES FURNISHED: Michael K. Blazicek, Esquire Jack McRay, Esquire Department of Professional General Counsel Regulation Department of Professional 730 S. Sterling Avenue Regulation Tampa, FL 33609-4582 1940 N. Monroe Street Suite 60 Si H. Azar Tallahassee, FL 32399-0792 3820 Gulf Boulevard, Apt. 1003 St. Petersburg Beach, FL 33706 Dorothy Faircloth Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792
