The Issue The issue to be resolved in this proceeding is whether Petitioner, as a child day-care facility operator, committed the violations of Florida Statutes and Florida Administrative Code, as alleged in the Administrative Complaint, of failing to obtain or maintain proof that at least one staff member physically has a valid certificate of training in first-aid and infant and child cardiopulmonary resuscitation procedures and that such staff member is physically present at the facility.
Findings Of Fact Petitioner is a licensed day-care facility licensed by the Department of Children and Family Services (Department). On May 11, 2001, Susan Kipen, Family Services Counselor, Day-Care Licensure, of the Department, conducted an inspection of the Petitioner's facility. During the May 2001 inspection, Kipen discovered that no member of the facility's staff had the required training in first-aid and infant and child cardiopulmonary resuscitation (CPR) and that no evidence of such training was contained in the facility's records. The Department cited the facility for noncompliance. On May 29, 2001, a warning letter was issued regarding the lack of training. The letter established a correction date of June 8, 2001. On August 28, 2001, the Department again inspected Petitioner's facility. The inspection revealed that no staff present at the facility had the required first-aid or CPR training and no certificate of such training was maintained in the facilities records. At least one staff person had completed the training, however, that person was not physically present at the facility. The Department again cited Petitioner for noncompliance.
Recommendation Having considered the foregoing Findings of Facts, Conclusions of Law, the evidence of record, and the candor and demeanor of the witness, it is RECOMMENDED that a final order be entered confirming the imposition of an administrative fine against Petitioner in the amount of $50.00. DONE AND ENTERED this 2nd day of May, 2002, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 2nd day of May, 2002. COPIES FURNISHED: Temple DePlato Head Start at Green Cove Springs 100 Bel Tel Way, Suite 100 Jacksonville, Florida 32216 Robin Whipple-Hunter, Esquire Department of Children and Family Services Post Office Box 2417 Jacksonville, Florida 32231-0083 Peggy Sanford, Agency Clerk Department of Children and Family Services 1317 Winewood Boulevard Building 2, Room 204B Tallahassee, Florida 32399-0700 Josie Tomayo, General Counsel Department of Children and Family Services 1317 Winewood Boulevard Building 2, Room 204 Tallahassee, Florida 32399-0700
The Issue Did Mary Moshier violate Section 464.21(1)(b) , Florida Statutes, as alleged in the Administrative Complaint?
Recommendation It is noted as a fact in mitigation that Moshier was suspended for 21 days by the hospital where she worked for the incidents that gave rise to this Administrative Complaint. Based upon the foregoing Findings of Fact and Conclusions of Law, and considering the facts in mitigation, the Hearing Officer recommends that Mary Moshier be placed on probation for a period of six months for the violation of Section 464.10(1)(f) , Florida Statutes, by using profane language regarding a patient in the vicinity of the patient. DONE and ORDERED this day of May, 1980, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1107 Blackstone Building 233 East Bay Street Jacksonville, Florida 32202 Joseph S. Farley, Jr., Esquire 350 East Adams Street Jacksonville, Florida 32202 Geraldine B. Johnson, R. N. Beard of Nursing 111 Coastline Drive East, Suite 504 Jacksonville, Florida 32202
The Issue An Administrative Complaint dated February 2, 1998, alleges that Respondent, Dennis Gross, M.D., violated Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. More specifically the Administrative Complaint alleges that Dr. Gross failed to properly diagnose and treat a 20-month old patient on August 8, 1994, which patient expired that same day.
Findings Of Fact Dennis Gross, M.D., is now and since December 31, 1973, has been licensed as a medical doctor in the state of Florida with license no. ME0021286. Dr. Gross is board-certified in pediatrics. He has had an active, private general pediatric practice in central Florida for the last 22 years, seeing an average of 30-35 patients a day. His practice consists of well child care, routine visits, physicals, and immunizations, but also includes acute care, illnesses, and injuries. His office hours are Monday through Friday and a half-day on Saturday; he routinely takes calls from his patients' parents and does not rely on his nurses to handle those calls. He also sees patients at night or on weekends at the hospital, but generally if a patient is critically ill and requires in-hospital care, he calls for a consult from a pediatric intensivist, a sub-specialty of pediatric care for critically ill children. Dr. Gross was the pediatrician for the M. family for about 12 years. R.M., a male child was born on November 18, 1992, and Dr. Gross began treating him from birth. During the course of his treatment of R.M., Dr. Gross learned that the child had a rare immunodeficiency syndrome, cyclic neutropenia, characterized by cyclical (generally 14-45 days) reduction in the patient's neutrophils (the most prevelant type of white blood cells.) R.M.'s father and older half-sibling also had this condition. When the patient's neutrophils are low, bacterial infections occur. In the infant R.M. such infections occured frequently. Between his birth and August 1994, Dr. Gross treated R.M. for various infections on approximately 24 occasions. These included boils and abcesses, infected rashes and other infections primarily localized on the skin. R.M. was also treated for normal childhood illnesses such as coughs, colds, and ear infections. On each occasion Dr. Gross was able to quickly identify the problem and treated it appropriately. For approximately 22 months R.M. thrived and achieved age-appropriate growth and developmental levels. On August 8, 1994, between 9:00 a.m. and 9:30 a.m., R.M.'s mother called Dr. Gross at his office and told him that R.M. had a low-grade fever and had vomited through the night. She said he had not vomited, however, within the 4 to 5 hours. Dr. Gross told the parent to put R.M. on clear liquids, to call back if the vomiting persisted, and to check back the following day anyway because of the child's history. Although the mother was aware of Dr. Gross' practice of seeing patients the same day on request she did not make such a request at that time. Instead, R.M.'s father, a school principal, stayed home with him in the morning and brought him to school to the mother, a teacher, in the later morning. R.M.'s mother took him home and apparently called Dr. Gross' office for a same-day appointment because she appeared with R.M. at the pediatrician's office around 3:30-4:00 p.m. When Dr. Gross entered the examining room, R.M. was walking around the room. Dr. Gross placed him on the examining table and observed an "alert and active child." His mouth appeared slightly dry and with the exception of increased bowel sounds and a rectal temperature of 104.1?, all other signs were normal. Dr. Gross told the mother that he felt R.M. had gastroenteritis, a viral infection, and told her he didn't want the child to dehydrate. He administered a shot of antiemetic and R.M. howled, a thoroughly normal reaction. Dr. Gross also prescribed Phenergan suppositories and told the mother to keep him on clear liquids slowly and call back if necessary. The child walked out of the office with his mother. Approximately 45 minutes later at home R.M. stopped breathing and was taken to the hospital. Dr. Gross was called to the hospital where CPR, epinephrine and other emergency measures were employed to attempt to revive the child. He was pronounced dead at 6:25 p.m. The autopsy determined that the cause of death was "septicemia, due to complications of cyclic neutropenia." More specifically, bacteriology studies revealed three species of clostridium, including clostridium septicum identified in the blood culture. (Petitioner's Exhibit No. 4, p. 5/83) The Standard Of Care The foregoing facts are substantially uncontroverted. The parties' dispute is whether Dr. Gross' diagnosis of R.M. on August 8, 1994, constituted failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. On this issue, the experts are at odds. Petitioner's sole witness was Dr. Lucian DeNicola, a professor of pediatrics in pediatric critical care medicine at the University of Florida Health Science Center in Jacksonville, Florida. Dr. DeNicola's opinion formed the basis for the Administrative Complaint in this case. Dr. DeNicola is board-certified in pediatrics and in pediatric critical care. With outstanding education and experience Dr. DeNicola has, nonetheless, very limited experience in an active outpatient general pediatrics practice such as Dr. Gross' practice. That practice was for 6 years at an outpatient clinic operated by the University of Massachusetts and that experience ceased approximately 16 years ago. Dr. DeNicola is an intensivist, specializing in the care of critically ill children. Based on R.M.'s history and the elevated temperature, Dr. DeNicola's opinion is that Dr. Gross should have suspected something serious, should have taken or ordered a blood culture, and should have immediately administered a broad spectrum antibiotic. Clostridia infections are virulent and highly toxic, but they are killed with antibiotics, usually a penicillin. Dr. DeNicola's opinion was considered and weighed in this proceeding but has been rejected in favor of the more relevant and, under the circumstances of this case, more credible, opinions of Respondent's witnesses. Dr. Raymond Caron is board-certified in pediatrics and has practiced in Orlando, Florida, for approximately ten years. A sole-practitioner like Dr. Gross, he sees children from birth through adolescence, providing a mix of routine well-child care and acute care. Dr. Cody Meissner's training and experience is closely analogous to that of Dr. DeNicola. That is, he practices medicine in a teaching hospital setting, through the Tuft's University School of Medicine in Boston, Massachusetts. Dr. Meissner is head of the Pediatric Infectious Disease Division at the New England Medical Center. He teaches, directs research, consults with pediatricians throughout New England, and spends several hours a day with patients in the hospital or emergency room. Dr. Meissner is board-certified in pediatrics and in pediatric infectious diseases. There are viral infections and bacterial infections. Viral infections do not respond to antibiotics and administering antibiotics indiscriminately is contraindicated and can be very detrimental. The indiscriminate use of antibiotics can create drug-resistent strains of infections and the antibiotics may ruin an outcome of subsequent blood cultures which are supposed to identify the potential bacteria. Dr. Gross did not have an in-office capacity to perform a blood culture nor did most his colleagues in private pediatric practice have that capacity. The standard of care did not require that capacity. Even a culture taken in an emergency room setting would have meant a several-hour delay between the time R.M. was seen by Dr. Gross and the results of the culture. In the meantime, the injection of an antibiotic by Dr. Gross would likely have masked the result of the culture and would have produced a false negative. More significantly, and even with Dr. Gross' foreknowledge of R.M.'s propensity for infections, nothing specifically in the child's condition on the afternoon of August 8, 1994, clued the pediatrician to the fact that the child was already full of deadly toxins. Bacterial infections, in contrast with viral infections, are generally identified with a focus of the infection: lesions, draining, inflammation, tenderness or localized pain or swelling. Impending septicemia typically is manifested by lethargy, limpness, cyanosis (paleness), low blood pressure, an inability to make eye contact, and severe irritability. R.M. presented none of these signs to Dr. Gross. R.M.'s very normal reaction to the injection would not be typically found in a child as sick as he truly was. Young children with temperatures of 104? are not extraordinary. Pediatricians in an active practice like Dr. Gross' may see several such patients daily, or weekly, depending on the season. Dr. Gross' diagnosis of gastroenteritis was consistent with his observations, examination and knowledge of the child's history. According to Dr. DeNicola, R.M. could have had an interferring viral infection that caused the earlier vomiting that set up the bacteremia. (deposition, p. no. 66) In summary, the standard of care as more credibly described by Respondent's witnesses did not require that Dr. Gross perform or order a blood culture or administer an antibiotic to R.M. on the afternoon of August 8, 1994.
Recommendation Based on the foregoing, it is hereby RECOMMENDED: that the Board of Medicine issue a Final Order dismissing the Administrative Complaint at issue. DONE AND ENTERED this 8th day of December, 1998, in Tallahassee, Leon County, Florida. MARY CLARK 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 Filed with the Clerk of the Division of Administrative Hearings this 8th day of December, 1998. COPIES FURNISHED: Carol A. Lanfri, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Martin B. Unger, Esquire Unger, Swartwood, Latham & Indest, P.A. Post Office Box 4909 Orlando, Florida 32802-4909 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela Hall, Agency Clerk Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether the Respondent committed the acts alleged in the administrative complaint contrary to Section 458.331(1)(t), Florida Statutes.
Findings Of Fact (Stipulated) The Respondent is and was at all times material to the allegations a licensed physician in Florida, holding license number ME 0050839 issued by the state. The Respondent was a board certified internist and board certified cardiologist practicing with Diagnostic Cardiology Associates at St. Vincent's Medical Center (St. Vincent's) at the time of the events which gave rise to these allegations. On or about June 25, 1988, W.V., referred to in the complaint as Patient #1, was admitted to St. Augustine General Hospital in St. Augustine, Florida. W.V. was a 68 year old male with a history of heart problems including four bypasses performed in 1977, a pacemaker implantation in 1979, chronic obstructive pulmonary disease, and prior prostate surgery. W.V. was determined to have had an acute myocardial infarction for which he was treated at St. Augustine General Hospital for five days. As W.V.'s condition improved, he was encouraged to walk at St. Augustine where he complained of chest pain and weakness. A echocardiogram showed segmental wall motion disturbance involving the posterior wall of the heart. A second electrocardiogram was performed which showed ventricular pacemaker rhythm and ST-T wave changes. On this basis, given his history and myocardial infarction, he was referred for a cardiac catheterization to St. Vincent's where his earlier heart surgeries had been performed. The patient was monitored during his hospitalization in St. Augustine, and did not show any signs of arrhythmias. On June 30, 1988, W.V. was transferred to St. Vincent's and received through the Emergency Room, where he was interviewed by the Respondent. After giving the Respondent a brief outline of his problems, W.V. was placed on a general medical floor for the evening, and scheduled for cardiac catheterization the following day. Cardiac catheterization and its risks were explained to W.V., who signed the patient consent forms authorizing the procedure. On the morning of July 1, 1988, after examining the patient and finding no changes, the Respondent performed on W.V. a cardiac catheterization, which verified the recent acute myocardial infarction, the blockage of two of the bypasses, damage to the heart muscle serving the lungs, and high vascular resistance with severe pulmonary hypertension. The patient tolerated the procedure well and showed no signs of arrhythmias during or after the procedure. The test results indicated that he could not benefit from surgery or angioplasty. W.V.'s primary health threat was from congestive heart failure, a condition likened to drowning in one's own fluids. (Tx-129, line 1.) A patient suffering from congestive heart failure will call for assistance from the nursing staff, as one of the expert's phrased it, "he would have been crawling out the door on his hands and knees calling for the nurse." (See Dr. Gilmore, Tx-130, line 8.) Conversely, heart failure alone would not have caused the patient to have chest pains, unless the patient developed elevated pressures to the point where pulmonary hypotension caused chest pain. However, the chest pain in such a case is not caused by clogged arteries or an impending heart attack, but by build up of fluid in the lungs which causes the heart to work harder to pump the blood through the lungs. (Dr. Campbell, Tx- 107, line 16.) The Respondent's post-catheterization order initially directed that W.V. be moved to a monitored bed following the procedure. The purpose of monitoring a patient is to observe, document and ultimately treat cardiac rhythm disturbances. (Dr. Gilmore, Tx-117,line 6.) Approximately 75 percent of post- catheterization patients were placed on telemetric monitoring (monitoring or telemetry hereafter). Monitored beds existed on 3 East (eight monitored beds), 5 East (eight monitored beds), Coronary Care Unit (eight monitored beds), Intensive Care Unit (12 monitored beds), and open heart unit which, although monitored, would not take catheterization patients. Notwithstanding the number of monitored beds, the critical piece of equipment is the monitor because each room on a monitoring unit was set up to receive telemetry. The monitor is a small radio transmitter that relays information from leads attached to the patient to receivers in each room. The monitors are removed by patients upon discharge, thrown into the laundry, and into the trash. They also require repair. As a result, the actual number of monitors varied from the planned number of monitored beds. Upon completion of the catheterization, the catheterization nurse would advise the nurse in charge of placing patients that the cardiac catheterization patient was ready for admission to the hospital, and whether the doctor had ordered a monitored or unmonitored bed. If the doctor had ordered a monitored bed and one was not available, the placement nurse would ask the admitting physician whether the patient being admitted really needed monitoring given the critical number of monitored beds available and the necessity to poll the treating physicians of all the monitored patients to see if any could be taken off monitoring. Inferentially, the Respondent considered the status of his other patients who were being monitored. If the physician deemed the patient's need for monitoring critical, then the placement nurse would poll the physicians of all other monitored patients, and request that they reassess the needs of their patients on monitoring. (See Lipsky Deposition, Page 26) The unit which normally received post-catheterization patients, 5 East, had eight monitored beds and eight unmonitored beds which were used as "stepdown" beds for patients taken off monitoring so that the monitors could be changed, but the patient retained in the same bed. Not only were all the monitored beds occupied on 5 East, the post-catheterization unit, but that unit had almost a full census. (See Lipsky Deposition, Page 20 - Page 26) The hospital's procedures required cardiac catheterization patients to remain in the catheterization laboratory until a monitored bed was available if the doctor stated that the patient was to go to a monitored bed. The catheterization patient would be held in the catheterization laboratory where there was a shortage of nursing care until a bed was found. Contrary to the experts' testimony which presumed the authority of the Respondent to place the patient in a monitored bed, it was the placement nurse who placed the patient once the doctor ordered a monitored bed post-catheterization. No evidence was received regarding her authority to place patients requiring monitoring in the ICU or CICU. Typically, doctors reassessed their patients' need for monitoring during morning rounds, and those that were stable were removed from monitoring so the monitor became available for a more critical patient. (See Libsky deposition, Page 24, line 20) W.V. catheterization was completed at approximately 11:00 a.m., following morning rounds when a maximum number of monitors should have been available; however, no evidence was received when a monitor would have been available. Testimony revealed that the wait could be as long as two hours for a monitored bed. During that time, under hospital protocols, W.V. would have remained in the catheterization lab. Contrary to facts assumed by the Petitioner's experts, the Respondent's options for placing the patient were: to place the patient in an unmonitored bed on the cardiac floor, or to retain the patient in a monitored bed in the holding area where he would be monitored by the cardiac catheterization nurse until the patient placement nurse found a monitored bed. The Respondent did not retain the patient in the cardiac catheterization area because the nurses could not adequately monitor W.V. and perform their other duties. The Respondent did not place W.V. in the Cardiac Care Unit or the regular Intensive Care Unit to obtain monitoring because it was not his function to place the patient. The only way he could have placed W.V. in CICU or ICU would have been to change W.V.'s status to justify the overall intensive care of the patient. However, this would have been unsupportable if questioned given the patient's condition which was stable upon admission six days after the myocardial infarction, and remained stable after the procedure. See Dr. Edwards Depostion, Page 41, line 19 et seq. Staffing levels on 5 East at the time of W.V.'s hospitalization were one nurse to four or five patients. There were five nurses, a charge nurse, and nursing assistant, and 22 beds on the unit. (See Lipsky Deposition, Page 72, line 15.) The Hospital's Standing Order 01-009 provided that "The critical care nurse, in consultation with the charge nurse, may initiate the following (list of nursing interventions) and notify the physician as soon as possible in the event of an acute deterioration [of] patient status and in the absence of a physician." (See Burnsed Deposition, Page 112, line 4) The Hospital Standing Order 01-017 provided "Any changes in the patient's condition will be called to the attention of the attending physician and appropriate consulting physicians. The emergency standing orders may be initiated by the nursing staff, but the physician must be informed of their use." (See Burnsed Deposition, Page 113, line 10) The Respondent placed the patient on 5 East, the cardiac care floor, in an unmonitored bed at approximately 11:50 a.m., as indicated by the notation on the patient's chart "nonmonitored," which indicated a change from the initial orders. (See Cavin Deposition, Page 34, line 7 and Page 35, line 7 et seq.) There was no order that W.V. should not be resuscitated. The Respondent's standing orders called for the patient's vital signs, together with shortness of breath and chest pain, to be monitored every 15 minutes for four hours. This was done until 3:15 p.m., when the monitoring was reduced to every 30 minutes. The Respondent advised the cardiac catheterization nurse, Mary Cavin, who accompanied the patient to the floor, of his findings, to include evidence of a recent myocardial infarction, and the patient's response to the procedure. (See Cavin Deposition, Page 19-20) Ms. Cavin identified her handwriting on the charts describing the Respondent's findings. However, these notes do not mention the recent myocardial infarction. The referenced notes were not sufficiently identified to check in the patient's charts. W.V. was taken to 5 East by Mary Cavin. Ms. Cavin had worked in this area at St. Vincent's for three years. Cardiac catheterization nurses were described by one of the experts as being among the best trained nurses in the profession, who because they work with the medical staff continuously during the procedures, are aware of the physician's findings and the patient's status. They pass this information along to the floor nurses when they transport the patients back to the floor. Ms. Cavin did not remember specifically W.V., but testified in her deposition regarding her normal practice when delivering a patient. She advised the staff on 5 East how the patient did during the catheterization, and what the findings had been. However, as stated above, in Cavin's notes she did not mention the recent myocardial infarction, and it is unclear whether she mentioned this to the staff of 5 East. The record is unclear to whom Ms. Cavin reported W.V.'s condition; however, Ms. Burnsed received a report on W.V. when she came on duty from Carolyn Johnson, the nurse who had cared for W.V. on the preceding shift. Ms. Burnsed was advised by Ms. Johnson that W.V. was stable post-catheterization, that he had previous open heart surgery, and that one of his grafts was blocked, but "had good collateral circulation to that." Further, Johnson advised Burnsed that W.V.'s vital signs were good, and he had no problems. Johnson did not mention the recent myocardial infarction suffered by W.V. Although Ms. Burnsed could not specifically remember her actions, her general course of action was to do a complete assessment upon starting the shift, make sure her patients were all right and having no problems, and orient them about the call light and calling her. Her physical assessment of W.V. revealed an apical heart rate of 72, respiration 18, and blood pressure of 100/70. W.V.'s vital signs were monitored by the staff of 5 East every 15 minutes as ordered by the Respondent until 3:15 p.m., when this was reduced to every 30 minutes. At 5:00 p.m., the Respondent saw W.V., who had no complaints and was stable. Ms. Burnsed found W.V. up going to the bathroom at 5:30 p.m., and got him back into bed explaining that it was important that he stay in bed because of his incision for at least 24 hours. Ms. Burnsed checked W.V.'s incision, and found that it was not bleeding at that time. At 7:00 p.m., Ms. Burnsed administered Lasix to W.V., and W.V. asked for and was provided sleeping medication at 9:00 p.m., at which time, Ms. Burnsed took W.V.'s vital signs which were essentially unchanged and stable. At 9:20 p.m. the patient's charts reflect that he was complaining of mild shortness of breath (SOB), and pains in his chest. Pursuant to the Respondent's orders, Ms. Burnsed administered nitroglycerin, 150 grains times one, after checking his blood pressure to insure it was within limits for the administration of nitroglycerine, and oxygen via nasal cannula, two liters, pursuant to emergency orders. This relieved the patient's symptoms. Ms. Burnsed did not report to the Respondent that W.V. had suffered mild shortness of breath and chest pain because the nitroglycerin and oxygen relieved his symptoms. The decision to notify or not to notify the treating physician was described as a nursing judgment based upon the nurse's assessment of the patient's condition after being medicated and placed upon oxygen. (See Lipsky Deposition, Page 56, line 8 et seq.) Ms. Burnsed did not consider the patient's condition to have deteriorated given his response to the medication, and did not notify the Respondent. Subsequent to administering the nitroglycerin and oxygen, Ms. Burnsed spoke with W.V.'s wife on the telephone. It is intimated in the depositions that Mrs. W.V. called to advise that her husband had called complaining of shortness of breath and chest pains and an inability to get anyone to assist him; however, no evidence was submitted regarding the content of the conversation between Ms. Burnsed and Mrs. W.V. Five to ten minutes after speaking with W.V.'s wife, Ms. Burnsed returned to W.V.'s room, where she found him resting in bed without complaint. W.V. stated that he wanted to go to sleep. Ms. Burnsed did not remember checking his vital signs on this second visit, and it is most probable that she did not because he was trying to go to sleep. Ms. Burnsed checked W.V. at 10:10 p.m., and found he was not breathing, had no pulse, and was unresponsive. The Cardiac Resuscitation Team was called, and responded. Despite their efforts, W.V. was pronounced dead at 10:50 p.m. Although a partial autopsy was performed which confirmed the findings of the catheterization and the diagnosis of a recent myocardial infarction, the cause of death was not precisely determined. It was assumed by the experts that W.V. did not die of congestive heart failure because he would have complained more. Therefore, the experts concluded that his death was relatively sudden, most probably brought on by an arrhythmia or perhaps a stroke. There was a suggestion that the Respondent did not put W.V. on a monitor because he had a pacemaker. While patients with pacemakers are at no less risk of developing arrhythmias than patients without pacemakers, there was no evidence that this was a consideration of Respondent in placing the patient on a cardiac floor following cardiac catheterization. It was general practice to place cardiac catheterization patients who exhibited signs of cardiac pathology on telemetry for 24 hours following the procedure. The initial orders of the Respondent were consistent with this practice. Testimony was received from the Petitioner's experts was that the Respondent's care was substandard because he did not place the patient on monitoring as they would have done by placing the patient in the emergency room, or the intensive care unit, or the cardiac intensive care unit to obtain telemetry monitoring, or retain the patient in the cardiac catheterization area pending the availability of a monitored bed. Their assumptions regarding the doctor's authority were inconsistent with the procedure for placing patients at St. Vincent's which was the function of the placement nurse. The Petitioner's experts also testified that placing a patient on telemetry notified the nursing staff that the patient required special attention. The Respondent's witnesses were more credible in stating that placing a patient on telemetry was not the way to indicate to nursing staff that the patient required special attention. The testimony of Respondent's witnesses that intensive care personnel were not as well trained as personnel on the cardiac floor to deal with cardiac emergencies is not credible. Both groups of personnel, if not equally versed in cardiac care, are sufficiently skilled in steps to be taken in the event of a cardiac emergency that there would be no appreciable difference in the care provided. Placing the patient in the regular intensive care unit or the cardiac intensive care unit would have required changing the patient's medical status be changed, and there was no change in the patient's condition which would have warranted the change. The patient was extremely ill upon admission, and his prognosis was very poor. W.V. was going to die because of his cardiac condition and chronic pulmonary congestion unless he had a stroke. His condition was irreversible in the opinions of the various experts; however, he would have been released the day following the catherization and treated medically for his problems. The Petitioner's experts opined that the Respondent's decision not to place W.V. in a monitored bed was substandard care because they felt that there was an ethical duty to monitor the patient in the absence of orders directing that efforts not be made to resuscitate notwithstanding the dismal chances for success. Their opinion assumed the Respondent could direct the placement of the patient in a monitored bed on a specific unit within a relatively short period of time because of all the monitored beds in the hospital. The Respondent's experts opined that the decision not to monitor W.V. was within the acceptable standards of medical care by physicians under similar circumstances, i.e., retain the patient in the catherization laboratory where nursing care would have been inadequate pending availability of a monitored bed for up to two hours. Their opinion considered the circumstances at St. Vincent's, and is deemed more credible.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the charges against the Respondent be dismissed. DONE and ENTERED this 2nd day of June, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of June, 1995. APPENDIX The parties filed proposed findings of fact which were read and considered. The following states which of those findings were adopted, and which were rejected and why: Petitioner's Recommended Order Findings Paragraph 1-3 Paragraph 1-3. Paragraph 4 Paragraph 5. Paragraph 5 Paragraph 3. Paragraph 6 Paragraph 6. Paragraph 7 While true, this finding is unnecessary to a consideration of the issues. Paragraph 8 Paragraph 7. Paragraph 9 Paragraph 9. Paragraph 10 Paragraph 32. Paragraph 11 Subsumed in Paragraph 37. Paragraph 12 Subsumed in Paragraph 38,39. Paragraph 13 Rejected as contrary to more credible evidence. Paragraph 14 If arrythmias were undetected, they would have been irrelevant to consideration of the patient's condition. Paragraph 15 Subsumed in Paragraph 9. Paragraph 16 Paragraph 46. Paragraph 17 Subsumed in Paragraph 9. Paragraph 18 Contrary to more credible evidence; See Parag 48. Paragraph 19 Rejected at Paragraph 43. Paragraph 20 Rejected at Paragraph 40. Paragraph 21 Rejected as contrary to more credible evidence; See Paragraph 12. Paragraph 22 Accurately states the expert's credentials, but is not relevant to consideration of the issues. Paragraph 23 Rejected as contrary to more credible evidence; See Paragraphs 42 and 47. Paragraph 24 Subsumed in Paragraphs 9,12,47-49. Paragraph 25 Rejected at Paragraph 16. Paragraph 26 See comments to Paragraph 22. Paragraph 27 See comments to Paragraph 23. Paragraph 28 While the may have been a national standard of care, there was not a national set of circumstances which impact the issue of whether the Respondent adhered to the appropriate standard of care. Paragraph 29 Subsumed in Paragraph 47. Paragraph 30 Subsumed in Paragraph 24. Paragraph 31 Subsumed in Paragraph 9. Respondent's Recommended Order Findings Paragraph 1 Paragraph 4,5. Paragraph 2,3 Paragraph 6. Paragraph 4 Paragraph 6,4. Paragraph 5 Paragraph 9. Paragraph 6 Rejected as contrary to most credible evidence; See Paragraphs 12-14. Paragraph 7-10 Subsumed in Paragraphs 17-19. Paragraph 11 Accurate; however, the patient was stable upon admission. Paragraph 12 Subsumed in Paragraph 46. Paragraph 13 Paragraph 46. Paragraph 14 Paragraph 24. Paragraph 15 Subsumed in Paragraph 25-28. Paragraph 16 Paragraph 24. Paragraph 17 Paragraph 31. Paragraph 18 Subsumed in Paragraph 33. Paragraph 19 Paragraph 37. Paragraph 20 Subsumed in Paragraph 46. Paragraph 21 Paragraph 38,48. COPIES FURNISHED: Hugh R. Brown, Esq. Agency for Health Care Administration 1940 N. Monroe St. Tallahassee, FL 32399-0792 Michael J. Obringer, Esq. Osborne, McNatt, Shaw, et al One Enterprise Center 225 Water St., Ste. 400 Jacksonville, FL 32202-5147 Marm Harris, M.D. Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esq. Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all time relevant to this proceeding, the Respondent was licensed to practice medicine in the state of Florida, having been issued license number ME 0020485. The Respondent has been licensed to practice medicine in the state of Florida since 1973. Respondent is Board Certified in Obstetrics and Gynecology having fulfilled the requirements of the American Board of Obstetrics and Gynecology. The requirements include a multi-year residency program in obstetrics and gynecology and successfully passing written and oral examinations. After graduating from medical school the Respondent completed a two- year residency in obstetrics and gynecology at St. Joseph's Hospital in Baltimore, Maryland. Respondent then spent one year as Chief Resident in Obstetrics and Gynecology at Lutheran Hospital in Baltimore, Maryland where approximately 2000 babies were born during the time Respondent was in residency. The Respondent then completed a two-year clinical fellowship in obstetrics and gynecology at Peninsula General Hospital in Salisbury, Maryland where approximately 3,000 babies were born each year during the time Respondent was in residency. Respondent received additional training in the subspecialty of fetal maternal medicine through a one-year fellowship at New Jersey Medical School. After the fellowship at New Jersey Medical School, Respondent served one year as a clinical instructor at University Hospital, affiliated with Mercy Hospital in Baltimore, Maryland. Since the time of his first residency, the Respondent has been involved in the delivery of several thousand babies. The Respondent moved to Florida in 1975 and has been engaged in the private practice of medicine since that time. The Respondent opened the Venice Obstetrics Clinic (Clinic) in 1983, and has served as its Medical Director since that time. The Clinic was at all times relevant to these proceedings licensed by the State of Florida in accordance with Sections 387.30 through 383.335, Florida Statutes, (referred to as the Birth Center Licensure Act). At all times relevant to these proceedings, the Respondent was permitted to perform surgical services (including episiotomies) and forceps delivery in the Clinic in accordance with the partial exemptions provided in Section 383.335(1), Florida Statutes. The Clinic's license has never been disciplined for noncompliance with Sections 383.30 through 383.335, Florida Statutes, or Chapter 59A-11, Florida Statutes, by the Department of Health and Rehabilitative Services (HRS), the agency charged with the responsibility of licensing and regulating birth centers. At all times relevant to these proceedings, Marcos Lara, M.D. acted as the Clinic's consultant, and was board certified with hospital privileges at St. Joseph's Hospital and at Faucett Memorial Hospital in Port Charlotte. In July 1988, the Clinic employed several nurses licensed by the state of Florida. At the time the patient K.Z. came into the Clinic, the nurse-to- patient ratio was two-to-one. Normally, the ratio was one-to-one. The patient's first visit to the clinic, and with Respondent, was on March 18, 1988. The patient continued with regular visits to the Clinic seeing the Respondent through July 8, 1988. On the patient's April 27, 1988 visit the Respondent gave the patient a score of "one" on the HRS, Pre-Term Delivery Risk Scoring Form (Form), indicating that the patient was a low-risk patient. On the patient's June 28, 1988 visit the Respondent gave the patient a score of "zero" on the Form, again indicating that she was a low-risk patient. The Respondent in scoring the patient's risk did not circle or use several of the risk factors listed on the Form that would have applied to the patient, including a patient under 20 years, single parent and low socioeconomic status. Based solely on the risk factors of (a) works outside of home, (b) younger than 20 years, (c) single parent, and (d) low socioeconomic status (based only on patient's level of education), and the points assigned those risk factors, the Respondent should have given the patient a score of "six". This would have placed her in the medium-risk classification which requires a score between six and nine points. However, since the patient no longer worked outside of the home on June 28, 1988, the date of the reevaluation, her score would have been "five", placing her in the low-risk classification. Many of the factors listed in the Form are risk factors used by obstetricians in assessing a patient's risk classification. However, many of the risk factors listed in the Form, including those risk factors used to assess this patient's risk classification, are not relied on solely by obstetricians, either singularly or in combinations, to assess a patient's risk classification. The purpose of the Form is to assist birth centers in assessing a patient's risk classification to determine whether the patient should be permitted to give birth in a birth center, and not to supplant the obstetricians' knowledge and skill in assessing a patient's risk classification. There is insufficient evidence to establish facts to show that Respondent's failure to correctly fill out the Form was the result of Respondent's failure to use his knowledge and skill as an obstetrician to properly assess the patient's risk classification and thereby fail to practice medicine within the prescribed standard of care. On June 28, 1988 the patient signed a form wherein she consented to the delivery of her child at the Clinic. At this time, the patient was advised of the risks of not delivering in a hospital and the advantages of delivering at a birth center. The normal period of gestation is 40 weeks. The methods used to calculate the estimated date of confinement (due date) are: (a) if a patient's menstrual periods are on a 28-day cycle, the due date can be determined by taking the last menstrual period (LMP) and adding 280 days; (b) substract three months from the LMP and add seven days; (c) an ultrasound can be used; (d) from the size of the fetus as determined by physical and pelvic examinations; and (e) fundal height measurement. None of these methods are absolutely accurate and therefore, the due date is considered an estimate. The fundus is the upper portion of the uterus which grows during pregnancy, with the cervix at the bottom portion of the uterus. The fundal height measurement is made from the top of the bone, which is the front of the pelvic, called the symphsis, to the top of the uterus. Both ends of this measurement are subjective in placement and vary between those making the measurement. Fundal height measurement is a way of determining the increase in size of the uterine content which is significantly, in normal cases, influenced by the growth of the fetus. The fundal height measurement is relevant to fetal age if it is consistent with other clinical assessments such as, how low is the baby to help determine the length, palpating to determine the width of the uterus, and a pelvic examination. Some obstetricians correlate the fundal height measurement with the gestation period where roughly one centimeter of fundal height equals one week of gestation, plus or minus two to four centimeters. While the Respondent measures the patient's fundal height at each visit, and did so with this patient, he does not use fundal height alone to determine the age of the fetus but uses fundal height in conjunction with other assessments found as a result of physical and pelvic examinations. On her first visit, the patient told the Respondent that her LMP had begun around the first part of December, 1987. Assuming the patient's LMP had begun on December 1, 1987, her due date should have been during the first week of September, 1988, using either method (a) or (b) above. Also on the patient's first visit the Respondent conducted physical and pelvic examinations. The physical examination consisted of palpation of the abdomen to note the size. The pelvic examination enabled the Respondent to assess the size of the uterus, which indicates the age of the pregnancy. Based on his physical and pelvic examinations of the patient on March 18, 1988 and the fundal height of 20 centimeters, the Respondent determined the age of the pregnancy to be 22 weeks with a due date of July 22, 1988. There was a difference in the due date calculated using the date expressed by the patient as her LMP as opposed to the due date determined by the Respondent from his clinical assessment as to the size of the fetus in conjunction with the fundal height. However, since the Respondent's clinical assessment did not reveal any problems, and the fact that approximately 25 percent of the pregnant women experience two or more false menstrual periods, the Respondent concluded that any size/date discrepancy was explainable. Therefore, the Respondent considered his determination of July 22, 1988 as the due date reasonable, and did not order an ultrasound since it was neither beneficial to the patient nor medically necessary at this point of the pregnancy. On April 27, 1988, June 8, 1988 and June 22, 1988 the Respondent measured the patient's fundal height as 23, 28 and 31 centimeters respectively. However, on these same dates the Respondent determined the age of the fetus to be 28, 34 and of the size of the fetus 36 weeks, respectively, based on his examination of the patient. On April 27, 1988, June 8, 1988 and June 22, 1988 the Respondent concluded that an ultrasound was not needed based on the same reasoning he had employed on March 18, 1988. On her June 28, 1988 visit, the Respondent performed physical and pelvic examinations, including palpating the abdomen, estimated the age of the fetus to be 39 weeks based on its size and advised the patient that her due date may be earlier than July 22, 1988, the initial due date. The fundal height measurement was 31 centimeters. Respondent's examination of the patient on her July 6, 1988 visit made him suspect twins and a possible abnormal delivery. Therefore, Respondent ordered an ultrasound. The ultrasound revealed a single baby in cephalic presentation (baby's head first), at term (fetus at least 37 weeks). The ultrasound did not indicate any problems in delivering the patient's baby. In fact, no risk factor was identified by the ultrasound. While the Respondent's records are sketchy in regard to his reasoning of the date/size discrepancy, the testimony of both the Respondent and Herbert F. Sandmire, M. D. supports the Respondent's reasoning in not ordering the ultrasound until the July 6, 1988 even though normally the date/size discrepancy may have justified the use of an ultrasound. Therefore, the Respondent was practicing medicine within the prescribed standard of care by not ordering an ultrasound until July 6, 1988 because there was sufficient reasons justifying the size/date discrepancy on the earlier dates, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. The patient went into labor on July 8, 1988. The patient arrived at the Clinic around 11:50 a.m. on July 8, 1988, and at that time her cervix was dilated two centimeters and was 100 per cent effaced. Nurses Sally Azima and Virginia Lane were assisting with the patient and made the notations on the Nurses' Notes, with Nurse Lane making the notes from 1:30 p.m. through 7:00 p.m. and Nurse Azima making the notes from 7:30 until the end of the Nurses Notes. The patient's fetal heart rate was monitored with a Doptone. A Doptone is a devise that is placed on the abdomen which allows the fetal heart beat to be heard in the room. At 5:27 p.m., the cervix was 9 centimeters, 100 per cent effaced with membranes bulging. At 7:00 p.m., the patient suffered dysfunctional labor. The patient's uterine contractions were irregular and weak. The Respondent decided to administer Pitocin to the patient in order to regulate her uterine contractions. Pitocin is a brand name for a drug that stimulates uterine contractions. Pitocin is used for dysfunctional labor. Pitocin does not increase any risk that is not already present, and no change in management decisions is needed merely because Pitocin is being administered to the patient. The Respondent administered Pitocin to the patient by making a single injection of one ampule (10 units) of Pitocin into an existing intravenous bag. Another method of administering Pitocin is referred to as the piggy- back system wherein the Pitocin is maintained in a separate bag and infused through the existing intravenous line. While the piggy-back system may be the preferred method of administering Pitocin to a patient, neither the Birth Center Licensure Act nor the prescirbed medical standard of care in July, 1988 required the use of the piggy-back system to administer Pitocin to a patient. At the time the Pitocin was injected, the existing intravenous bag contained approximately 900 milliliters of fluid, plus or minus 20 milliliters. The Respondent set the IV flow rate at 20 drops per minute which resulted in a dosage level of approximately 10 milliunits per minute. While a dosage level of 10 milliunits per minute of Pitocin is higher than what was previously thought to be the correct dosage level of Pitocin, a patient could benefit from the higher dosage level of Pitocin, particularly under the circumstances and conditions that existed with this patient on July 8, 1988. The Respondent was practicing medicine within the prescribed standard of care when he administered the higher dosage level of Pitocin to the patient on July 8, 1988, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. After setting the IV flow rate at 20 drops per minute, the Respondent instructed Nurse Azima to monitor the flow to be sure the flow remained at 20 drops per minute. Nurse Azima checked the flow by counting the drops with a second hand on her watch every 15 to 20 minutes. Nurse Azima, under the supervision of Respondent, has administered Pitocin using the drop count method ever since Respondent's residency in obstetrics. While the use of an infusion pump may be the preferred method of administering Pitocin by some obstetricians, the Respondent was practicing medicine within the prescribed standard of care when he used the drop count method of administering Pitocin to the patient on July 8, 1988 rather than using an infusion pump. His use of the drop count method, including allowing Nurse Azima to monitor the flow, met the prescibed standard of care, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. An electronic fetal monitor records both the baby's heart rate and the mother's uterine contractions, and presents this information on a graph. The Respondent did not use an electronic fetal monitor while administering Pitocin to the patient on July 8, 1988. Instead, Respondent used intermittent auscultation. Intermittent auscultation involves using a stethoscope or Doptone to listen to the fetal heart beat at prescribed intervals. A nurse is assigned to check the baby's heart beat periodically and to notify the physician of any abnormality. When an electronic fetal monitor is used, a nurse is assigned to watch the chart and notify the physician of any changes indicated by the chart. Intermittent auscultation is equivalent to electronic fetal monitoring when it is done on a frequent basis, such as listening every 30 minutes when the patient is in the active part of the first stage of labor and every 15 minutes during the second stage of labor. Pitocin was administered by the Respondent at 7:00 p.m. and thereafter, Nurse Azima checked the fetal heart rate every 15 to 20 minutes. However, she did not record the fetal heart rate each time because the fetal heart rate was within an acceptable range, nothing was abnormal. The Nurses Notes indicate that Nurse Azima recorded the fetal heart rate at 7:30 p.m., 8:30 p.m., 9:00 p.m. and 9:35 p.m. There was no indication of any abnormality in the patient's heart rate or of any fetal distress at any time during the course of the patient's labor. Again, while the use of an electronic fetal monitor may be preferred by some obstetricians, the Respondent was practicing medicine within the prescribed standard of care when he used intermittent auscultation instead of an electronic fetal monitor and in his use of intermittent auscultation on July 8, 1988, notwithstanding the testimony of Robert Brauner, M. D. or the information contained in the Physician's Desk Reference to the contrary. At 7:30 p.m. the patient was fully dilated and the fetal head was at "zero" station. Station refers to the progress of the fetal head down the pelvis toward the outside. When the very edge of the fetal head is even with an imaginary line drawn between the patient's two spines (prominence in the middle of patient's pelvis) the fetal head is considered at zero station. Progressing past zero station would be indicated as zero-plus-one station, plus-two, etc. Progressing past plus-three station would be delivery of the fetal head. At 8:00 p.m., the fetal head was in right occiput posterior (ROP) position. This means the baby's face, as the mother is lying on her back, is looking up and, is a less favorable position for delivery, in that it usually leads to a longer labor. At 8:30 p.m., an hour after the patient had been fully dilated, the fetal head was at zero-plus-one station. The fetal head was now in the occiput anterior (AO) position, meaning the baby is now looking straight down while the mother is lying on her back. This position is the favorable position for delivery. The patient was transferred to the procedure room, prepped and given a local anesthetic when the fetal head was at plus-one to plus-two station. Thereafter, the Respondent noted that patient was fully dilated, fetal head was at plus-two station, but there was no further descent of the head. At this point, the Respondent decided that the patient should be assisted in the delivery by using the forceps to bring the fetal head down and deliver the baby. Before applying the forceps, the Respondent performed an episiotomy on the patient. An episiotomy is a obstetrical cut made between the vagina and the rectum (the perineum), through the tissue, separating the muscle to help open the vagina for delivery. The decision on whether to perform the episiotomy before or after applying forceps is a matter of clinical judgment based upon the physical characteristics of the patient, in particular the size of the introitus and the perineum. The Respondent decided to perform the episiotomy on the patient before applying the forceps based on his clinical judgment of what was best for the patient. Forceps are obstetrical instruments used to assist in the delivery of the fetal head. The Respondent used Simpson forceps, a commonly used forceps, which are designed to come apart. The Respondent attempted forceps delivery several times without success, even with the patient pushing and fundal pressure being applied simultaneously by Nurse Azima and Nurse Lane. Fundal pressure is applied by pressing down on the top of the patient's abdomen to help in the delivery of the baby and is a fairly common obstetrical procedure. During the attempt to deliver the baby with the forceps the IV came out but was restored by the Respondent. The Pitocin was discontinued at this time. The Respondent was practicing medicine within the prescribed standard of care when he performed the episiotomy before the use of the forceps and in his attempt to delivery the baby with the forceps, notwithstanding Dr. Brauner's testimony to the contrary. After the unsuccessful attempt to deliver the baby with forceps, the Respondent decided to transfer the patient to a hospital for a cesarean section. Nurse lane was instructed by the Respondent to call for an ambulance. Nurse Lane called the Sarasota Fire Department which responded in approximately three minutes. After calling the Sarasota Fire Department, Nurse Lane called St. Joseph's Hospital and advised the hospital that the patient would be on the way. The episiotomy was not bleeding excessively and the bleeding could be controlled by packing the incision with gauze sponges and keeping the patient lying down with her legs together. Since the repair of the episiotomy would have required 10 to 15 minutes, the Respondent, using his best clinical judgment, decided to control the bleeding as set out above rather than to repair the episiotomy and delay the patient's transport to the hospital. The patient's life or well-being was not threatened by not repairing the episiotomy. While blood loss is a concern, specially for someone facing an operation, apparently the blood loss for this particular patient was not an overriding concern since the decision was made at the hospital not to repair the episiotomy until after the cesarean section, some two hours later. Under the circumstances and conditions existing at the time, the Respondent was practicing medicine within the prescribed standard of care when he, in his best clinical judgment, decided not repair the episiotomy which would have delayed transporting the patient to the hospital. Upon arrival the paramedics were advised of the patient's condition, that the patient was to be transported to St. Joseph's Hospital and that the Respondent was attempting to reach Respondent's back-up physician. However, the Respondent did not want to delay transport of the patient to the hospital so he advised the paramedics to proceed to St. Joseph's Hospital in Port Charlotte before he had made contact with the back-up physician, other than with the doctor's answering service. On July 8, 1988 the Respondent's consultant (back-up obstetrician) was Dr. Lara, who was a Board certified obstetrician with hospital privileges at St. Joseph's Hospital in Port Charlotte. After the ambulance had departed for St. Joseph's Hospital, the Respondent, being unable to make contact with the Dr. Lara other than with answering service, called St. Joseph's Hospital and advised them of the patient's condition, Nurse Lane having already called the hospital to advised them that the patient was being transported there. In route to St. Joseph's Hospital, the paramedics made their own assessment of the patient's conditions and, under the conditions and circumstances existing at that time, decided to reroute the patient to the Venice Hospital which was closer. Venice Hospital did not have an obstetrical unit. Therefore, contact was established with a Dr. Chen, the supervising emergency room physician, who advised the paramedics to transport the patient to Venice Hospital for evaluation. After examining the patient, Dr. Chen called the Respondent and told him that he thought the patient was ready to deliver. However, after the Respondent told Dr. Chen of the patient's condition and not to delay getting the patient to a hospital with obstetrical service, Dr. Chen directed transport of the patient to Memorial Hospital in Sarasota. After talking with Dr. Chen, the Respondent called the Memorial Hospital, discussed the patient's condition with the nurse on the obstetrics floor, advised the nurse of what had been attempted with the patient, and that in his opinion a cesarean section was necessary. The Respondent left his phone number with the nurse so that the obstetrician handling the case could call the Respondent, if necessary. The obstetrician handling the patient's care at Memorial Hospital did not call Respondent and Respondent made no attempt to call the obstetrician. The patient was admitted to Memorial Hospital at 11:40 p.m., and was monitored with an external monitor for nearly 55 minutes before being taking to the operating room at 11:34 p.m. where she underwent an emergency cesarean section delivery at 11:49 p.m. After the delivery, the patient's episiotomy was repaired. Although the baby had forceps marks graded from "no marks" to "bad forceps marks" by personnel at Memorial Hospital, there was no evidence that the baby was in any way affected by the Respondent's attempted forceps delivery. The mother and the baby fared well while in the hospital and were discharged on July 12, 1988. There is competent substantial evidence to establish facts to show that the Respondent was practicing medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances throughout the treatment and management of the patient, K. Z. from March 18, 1988 through July 8, 1988. During the course of the hearing the Department stipulated on the record that it did not intend to pursue Count III of the Administrative Complaint (failure to keep written medical records justifying the course of treatment for the patient) and presented no evidence on this charge.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing Counts I, II, III, IV, and V of the Administrative Complaint filed in this case. RECOMMENDED this 15th day of February, 1993, at Tallahassee, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of February, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-3149 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the parties in this case. Petitioner's Proposed Findings of Fact. The following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parenthesis is the Finding(s) of Fact which so adopts the proposed finding(s) of fact: 1(1); 2(9,14); 3 -11 (15,24,30,32,32,26,27,29,and 28,respectively); 12(28,29); 13(32); 14(25,27); 15(25); 16(38); 17(32-34,36 and 38); 24(37); 26(28,29); 27 - 30(16-18 and 22, respectively); 32 - 35(19); 36(43,46); 38(51,53); 43(52); 47(55); 50(46); 52 - 59(60 - 63,65,67,68); 61(66); 64(74); 67(74); 68(75); 70(74- 76); 72-74(67,68); 76(69); 79-89(72-75,77,80-84); 90-94(77- 79,82,83); 96-97(83,84); 100(84); and 105-106(85). The following proposed findings of fact are not supported by competent substantial evidence in the record: 19, 21, 23, 25, 39-42, 44, 45, 48, 49, 51, 62, 63, 69, 71, 78, 95, 98, and 99. The first sentence of proposed findings of fact 18, 20, 22 and 37 are adopted in Findings of Fact 32, 34 and 44. The balance of proposed findings of fact 18, 20, 22 and 37 are not supported by competent substantial evidence in the record. The following proposed findings of fact are neither material nor relevant to the conclusion reached in the Recommended Order: 31, 46, 60, 65, 66, 75, 77, 101 - 104 and 107. 6. The Findings of Fact 1 - 30 concerning Expert Witnesses go to the credibility of those expert witnesses and are not addressed in the Findings of Fact. Respondent's Proposed Findings of Fact. Proposed findings of fact 1 - 11 are adopted in substance as modified in Findings of Fact 2 - 12, respectively. Proposed finding of fact 12 is unnecessary. Proposed findings of fact 13 and 14 are adopted in substance as modified in Finding of Fact 13. Proposed findings of fact 15 and 16 are adopted in substance as modified in Findings of Fact 14, 15 and 19. Proposed findings of fact 17 - 24 are adopted in substance as modified in Findings of Fact 25, 27, 30 - 33 and 84. Proposed findings of fact 25 - 29 are adopted in substance as modified in Findings of Fact 27, 28, 31, and 34. Proposed findings of fact 30 - 36 are adopted in substance as modified in Findings of Fact 25,33 and 37. Proposed findings of fact 37 - 45 are adopted in substance as modified in Findings of Fact 16 - 24. Proposed findings of fact 46 - 52 are adopted in substance as modified in Findings of Fact 39 - 42. Proposed findings of fact 53 - 56 are adopted in substance as modified in Findings of Fact 43 - 45. Proposed findings of fact 57 - 61 are adopted in substance as modified in Findings of Fact 46 - 49. Proposed findings of fact 62 - 68 are adopted in substance as modified in Findings of Fact 50, 51 and 69. Proposed findings of fact 69 - 88 are adopted in substance as modified in Findings of Fact 52 - 58. Proposed findings of fact 89 - 94 are adopted in substance as modified in Findings of Fact 59 - 64. 15 Proposed findings of fact 95 - 100 are adopted in substance as modified in Findings of Fact 65 - 71. Proposed findings of fact 101 - 110 are adopted in substance as modified in Findings of Fact 71 - 76. Proposed findings of fact 111 - 129 are adopted in substance as modified in Findings of Fact 77 - 83. Proposed findings of fact 129 - 137 are adopted in substance as modified in Findings of Fact 84 - 86. Proposed findings of fact 138 - 162 are matters relating to the witnesses and go to the credibility of those witnesses and are not addressed as Findings of Fact. COPIES FURNISHED: Michael K. Blazicek, Esquire Senior Attorney Department of Professional Regulation 730 South Sterling Avenue, Suite 201 Tampa, Florida 33609-4582 Darol Carr, Esquire Farr, Farr, Emerich & Hackett, P. A. 2315 Aaron Street Post Office Box 2159 Port Charlotte, Florida 33949 James W. Linn, Esquire Carson, Linn & Adkins 1711-D Mahan Station Tallahassee, Florida 32308 Dorothy Faircloth Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
The Issue Whether the Agency for Health Care Administration (AHCA or Agency) was entitled to change the rating of Gulf Coast Convalescent Center (Gulf Coast) from Standard to Conditional.
Findings Of Fact Gulf Coast is a nursing home located in Panama City, Florida, which is duly licensed under Chapter 400, Part II, Florida Statutes. AHCA is the state agency which licenses and regulates nursing homes in the state. As such, it is required to evaluate nursing homes in Florida, pursuant to Section 400.23(8), Florida Statutes. AHCA evaluates all Florida nursing homes at least every 15 months and assigns a rating of Standard or Conditional to each licensee. In addition to its regulatory duties under Florida law, the Agency is the state "survey agency" which, on behalf of the federal government, monitors nursing homes which receive Medicaid or Medicare funds. Ms. Bonnie Cile Baxter is employed by AHCA in the Division of Managed Care and Health Quality Assurance, Area Two. She is a registered nurse specialist and a graduate of the Florida State University School of Nursing. She has been a registered nurse for 27 years. She currently conducts surveys of nursing homes as required by state and federal law in AHCA's Area Two. Ms. Baxter visited Gulf Coast while conducting a licensure survey report. The survey began on March 13, 2000, and ended on March 15, 2000. As a result of the survey, a Statement of Deficiencies was issued on March 15, 2000. This report is referred to as a TAG 314. The report alleged Class II deficiencies. A Class II deficiency occurs when the outcome of the resident care directly affects the health, safety, or security of the resident. The TAG 314, set forth on a "2567" form, entered into evidence as Petitioner's Exhibit 1, is, in effect, the charging document. The residents to be checked were determined off-site by AHCA, prior to the survey. The information used to make these decisions was provided by the facility. The focus of the survey was pressure sores and nutrition and the four residents who were observed are referred to as Residents 16, 26, 22, and 15. Resident 16 Resident 16 was approximately 75 years of age. Ms. Baxter observed Resident 16 on March 13, 2000 at 9:00 a.m. Ms. Baxter observed that Resident 16 had a stage IV pressure sore. Pressure sores are evaluated in stages, beginning with stage I; a stage IV is the worst stage. A stage IV pressure sore may be open or closed, and it involves more than just the outer skin. A stage IV pressure sore involves severe damage to tissue. When evaluating the treatment of a resident with pressure sores, the evaluator observes the assessment and care plan and determines whether nutritional considerations have been addressed. The plan is evaluated to determine if it is sufficiently aggressive. What is implemented depends on the resident's need and the resident's desire. If the resident is incompetent to determine what care the resident wishes to accept, then a guardian may make the determination. Resident 16 was unable to make cognitive choices. Kimberly Roland, the Special Services Director at Gulf Coast at the time of the survey tried to contact Developmental Services of the Department of Children and Family Services with regard to a care plan for Resident 16 but the Agency asserted that it did not get involved with medical decisions. Ms. Baxter also tried, unsuccessfully, to determine who was authorized to make medical decisions on behalf of Resident 16. Resident 16 had been admitted to Gulf Coast on September 16, 1999. Facility staff noted that Resident 16 was first observed with a stage I pressure ulcer on February 1, 2000. The care plan developed by the facility in the case of Resident 16 did not facially address the pressure sore problem because it lacked specificity. Excellent nutrition serves to prevent pressure sores and to promote their healing. During the period subsequent to February 1, 2000, Resident 16 was without dentures, and this negatively affected her ability to ingest the type of foods which would address Patient 16's nutritional needs. There were discrepancies in Exhibit's 5, 7, and 8. Exhibit 5, which memorialized a one-time visit with a physician from Bay Psychiatric Services on February 12, 2000, indicated that Resident 16 did not exhibit symptoms of tardive dyskinesia, yet Exhibit 7 indicates that Resident 16 could not wear dentures because of involuntary movements related to tarsive dyskenesia on February 23, 2000. Exhibit 8, nurses' notes, indicate the presence of tardive dyskenesia involving movements of the tongue and body on January 27, 2000. Petitioner's Exhibit F demonstrated that Resident 16 had tardive dyskenesia symptoms, which resulted from long-time Mellaril use. The symptoms reported included involuntary movements of the tongue, which precluded the use of dentures. These involuntary movements were present on September 19, 1999. Mr. Gilliland, a licensed practical nurse with many years' experience working in nursing homes, stated he noticed that Resident 16 manifested involuntary movements of the tongue and body in December, 1999. If a person has tardive dyskenesia, it may preclude the utilization of dentures. The disappearance of Resident 16's dentures indicated a deficiency in security procedures but even if Resident 16 had dentures available, Resident 16 could not masticate hard food. Resident 16 had been on a mechanical soft diet prior to January 20, 2000. Subsequently, when Resident 16 no longer had the ability to masticate food, Resident 16 was put on a pureed diet. Resident 16's condition was the subject of an "at risk" meeting by the facility staff on February 15, 2000. Subsequently, Resident 16's nutritional needs were addressed with an enhanced diet. Resident 16 was provided with multi- vitamins and milkshakes twice a day in addition to other food. From February to March 2000, Resident 16 lost weight. The facility staff's efforts to provide Resident 16 with proper nutrition were appropriate under the circumstances. The first pressure sore on Resident 16 was found on February 1, 2000, and it was already a stage II without drainage. On February 18, 2000, the sore had advanced to a stage III and an additional pressure ulcer had formed on Resident 16's hip. This latter ulcer was also a stage II. By February 25, 2000, the ulcer on the hip changed to stage III and there was some draining. Subsequent to the inception of the ulcers, Resident 16 had been placed on a pressure reduction mattress. On March 3, 2000, more frequent turning was ordered by her attending physician. Mr. Gilliland observed that Resident 16 was mentally incapable of decision-making. Mr. Gilliland spent a lot of time with Resident 16. He was emotionally attached to Resident 16 who, to him, ". . . was like a little child." He spent a lot of time with Resident 16, kept Resident 16 clean and dry, and turned her frequently. At the time of the survey, the representatives of the state insisted that Resident 16 be fed through a tube. Dr. Haslam, Resident 16's physician, would not have ordered tube feeding had not the surveyors insisted that it be done. Resident 16 objected when Mr. Gilliland put the feeding tube in her nose. Resident 16 removed the tube. Mr. Gilliland put the tube in three or four times. Each time, Resident 16 removed it. When Dr. Haslam was informed of this, he told Mr. Gilliland that he could discontinue using the feeding tube. Resident 16 ate until two days before she died. When Resident 16 was admitted to Gulf Coast on September 3, 1999, Resident 16 could ambulate with assistance and was incontinent of bladder and bowel. By the time of the survey, Resident 16 could not walk at all and was bladder and bowel incontinent. At the time of the survey, and for several months before the survey, Resident 16 was bowel and bladder incontinent, had impaired mobility, and was an insulin-dependent diabetic. Resident 16 had occlusion of the arteries and veins of her lower extremities, which resulted in poor circulation. These are high-risk conditions for pressure wounds. Resident 26 Resident 26 was admitted to Gulf Coast on June 7, 1998. Resident 26 required extensive care with daily living activities and was approximately 83 years old at the time of the survey. On August 14, 1999, a stage I pressure sore was observed on the coccyx of Resident 26. By August 20, 1999, the pressure sore had become a stage II. By October 1999, the pressure sore on the coccyx had become a stage IV, and pressure sores had developed on the Resident 26's knee and on the left heel. Both of these sores were diagnosed as stage II. By November 11, 1999, the pressure sore on the coccyx was causing pain to Resident 26. It was determined on November 16, 1999, that the wound on the coccyx was infected with methicellin- resistant staphylococcus aureus (MRSA). MRSA is a type of infection that is resistant to antibiotics. It is communicable, and it is imperative that it be controlled. Vancomycin is the antibiotic of choice when treating MRSA. Resident 26 was administered Vancomycin and procedures were instituted to determine its effectiveness. The facility's staff determined that it would be best if a PICC line was installed in Resident 26. A PICC line is a method for administering antibiotics intravenously. In the case of Resident 26, records which tracked the status of the MRSA, were inadequate. Resident 26 refused to allow the PICC line to be placed. There is no indication whether Resident 26 refused Vancomycin administered in some other manner. On November 19, 1999, Dr. Ernest Haslam was notified of Resident 26’s refusal to allow installation of the PICC line. This information was not available at the time of the survey. At the time of the survey there were no documents indicating that the infection was being properly tracked or that there was an adequate treatment plan. The care plan for the treatment of Resident 26's pressure sores addressed providing proper nutrition, which included dietary supplements and pressure-relieving devices. Resident 26 was offered a feeding tube but Resident 26 declined. The implementation of the feeding tube was discussed by Resident 26's doctor with Resident 26's family and together they decided not to use it. The nutrition provided for Resident 26 was acceptable under the circumstances. Resident 26 was, at the time of the survey, and for several months before the survey, incontinent of both bowel and bladder. Resident 26's rheumatoid arthritis was so severe that Resident 26 was required to ingest anti-neoplastic drugs, which can kill cells. Resident 26 was admitted with a diagnosis of failure to thrive. Resident 26 was required to take Prednisone, which can contribute to the formation of pressure sores. Resident 26's albumin level was high, and a high albumin level promotes the formation of pressure sores. Resident 26 had a living will and had provided instructions not to resuscitate and resisted necessary treatment. These factors put Resident 26 at a high risk for pressure sores. Resident 22 Resident 22 was 67 years of age upon admission to Gulf Coast on May 12, 1999. Resident 22 had an open surgical wound on the hip upon admission, along with a fractured hip and gastrointestinal bleeding. Resident 22 also was anemic and had cardiovascular disease. On July 7, 1999, Resident 22 had a stage II pressure sore on the right heel, which had been present on admission. On September 2, 1999, it was noted that the left hip was infected and antibiotics were administered. On October 13, 1999, it was noted that Resident 22 had a stage III pressure sore on the right heel and a stage II open area on the right lateral foot. Poor nutrition was not a contributing factor with regard to Resident 22's pressure sores. On May 29, 1999, bilateral profo boots were prescribed for Resident 22, to be used for positioning of the feet while in bed. Dr. Osama Elshazly ordered the use of the profo boots. The use of profo boots was not included in the plan of care. Dr. Elshazly discontinued the use of the boots on January 1, 2000. There was speculation among the facility staff that the profo boots may have contributed to the pressure sores. Resident 22, at the time of the survey, and for several months before the survey, had pressure sore risk factors of diabetes mellitus, end-stage renal disease, coronary artery disease and arteriosclerosis obliterans. This latter condition means that the circulation in Resident 22's lower extremities was poor. Resident 15 Resident 15 is 87 years of age. Resident 15 was admitted to Gulf Coast on September 13, 1994. Upon admission, Resident 15 had ingrown toenails, a deformed left hammer toe, and other medical conditions involving the feet. Resident 15 required extensive assistance from staff in the activities of daily living and received nutritional support in the form of tube feeding. On December 17, 1999, Resident 15 was admitted to the Bay Medical Center due to a cerebrovascular accident, which is commonly referred to as a "stroke." Resident 15 was returned to Gulf Coast on December 23, 1999. After the cerebrovascular accident, Resident 15 was even less mobile and suffered a decline both mentally and medically. On March 1, 2000, Resident 15 was noted as having a pressure sore on her left bunion. Staff informed Ms. Baxter that they believed it occurred because Resident 15 had limited mobility. Resident 15, at the time of the survey and for several months before the survey, had pressure sore risk factors of bowel and bladder incontinence, congestive heart failure, and peripheral vascular disease. Resident 15 was a noninsulin- dependent diabetic.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a final order finding Petitioner not guilty of the alleged deficiencies and reinstating Petitioner's license rating to Standard as of March 15, 2000. DONE AND ENTERED this 27th day of December, 2000, in Tallahassee, Leon County, Florida. HARRY L. HOOPER 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 27th day of December, 2000. COPIES FURNISHED: Christine T. Messana, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Donna H. Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308
Findings Of Fact Based upon the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner's facility opened in January of 1976 as the Hubert Rutland Hospital. Its name was subsequently changed to Gateway Community Hospital and, after purchase by petitioner, it became Humana Hospital Northside. Dr. D. K. Mukherjee, Board-certified in internal medicine and cardiology, came to petitioner's facility in 1976 for the prime purpose of developing a cardiac catheterization laboratory, and assisted in preparing a list of equipment necessary to begin operation of such a laboratory. On December 31, 1976, petitioner's predecessor entered into a medical equipment service agreement for cardiac catheterization and monitoring equipment. That equipment, costing less than $100,000.00, was delivered to the hospital on or before June 17, 1977. Since that time, cardiac catheterization procedures, as defined in Rule 10-5.11(15), Florida Administrative Code, have been performed on a continuous and regular basis at petitioner's facility in Special Procedures Room No. 3. Over the past eight to nine years, the longest interval between the performance of such procedures has been approximately one or two weeks. Special Procedures Room No. 3, while also utilized for other purposes, has the equipment, staff and support services necessary for providing the studies and procedures associated with cardiac catheterization. The hospital itself is capable of providing the ancillary diagnostic services, such as hematology studies, electrocardiography, chest x-rays, blood-gas studies, pathology, blood chemistry analysis and nuclear studies pertaining to cardiology. Prior to July 1, 1977, Certificate of Need review was not required for the purchase of cardiac catheterization equipment by a hospital unless it involved a capital expenditure of more than $100,000.00. Commencing on July 1, 1977, Certificate of Need review was required when a health care facility sought to provide a substantial change in service, defined as a service which was not offered on a regular basis within the prior twelve-month period. Section 381.494(1)(c), Florida Statutes, and Rule 10-5.02(19), Florida Administrative Code. Because of technological and scientific advances, petitioner desired to replace and update the equipment purchased in 1976 for the performance of special procedures. Accordingly, in April of 1984, it submitted an application for a Certificate of Need to replace special procedures equipment at a project cost of $1,269,000.00. The application, in Section 3 stating the need and justification for the project, noted that: "Our existing equipment is totally inadequate to perform state-of-the-art cardiac catheter- ization and coronary angioplasty. When we began performing cardiac catheterization in 1977 this equipment was adequate, but today it is totally unacceptable. This proposed equipment will not only provide state-of-the- art equipment for these procedures, but will do so in a cost-effective manner since combined utilization of such high cost equip- ment contributes to the reduction of the cost of medical care." HRS issued petitioner Certificate of Need number 3261 for the replacement of special procedures equipment at a total project cost of $1,269,000.00, as requested. However, in a cover letter transmitting the issued Certificate of Need to the petitioner, HRS noted: "Please be advised that neither this office, the Office of Licensure and Certification nor the Local Health Council has documen- tation to support the performance of cardiac catheterization procedures at this hospital." Local Health Councils are private nonprofit corporations which contract with HRS to conduct local planning activities, including the collection of data, the publication of various utilization reports and the development of Local Health Plans. When HRS reviews proposed health care projects which require a Certificate of Need, it utilizes the data submitted to it by the various Local Health Councils, particularly in those instances where its rules contain a methodology or formula which includes as a factor an accounting of existing facilities or services. Application of the methodology contained in HRS's rule for determining the need for additional cardiac catheterization laboratories requires a knowledge of the number of procedures performed per year by existing and approved laboratories. Rule 10-5.11(15), Florida Administrative Code. The Health Council of Pasco/Pinellas, Inc. collects data from hospitals within Pasco and Pinellas Counties regarding bed utilization and service information. Hospitals in the district are requested to complete and submit certain information on a "Monthly Hospital Utilization Form." Among the items of information requested is the number of cardiac catheterization procedures performed during the reporting period. The Health Council also publishes and distributes annual and semi-annual utilization reports for the district. There is no provision in the statutes or rules which require hospitals to report utilization or service data to the various Local Health Councils, and HRS itself does not require that such information be reported to it. It is not unusual for hospitals to report inaccurate, incomplete or inconsistent data to Local Health Councils. Indeed, it is recognized in the "1984 Annual Hospital Utilization Report for District V Pasco/Pinellas Health Council, Inc." that, while all hospitals in the District submitted monthly hospital utilization information, "One limitation to this report involves those institutions who did not, for various reasons, submit data for beds by service categories and/or data pertaining to specialty services." HRS Exhibit F, p. 1. The form utilized by the Pasco/Pinellas Health Council contains no definition of cardiac catheterization procedures and no directions as to how to complete the form. While it has regularly submitted a monthly utilization form to the Local Health Council, petitioner has never reported the performance of cardiac catheterizations at its facility. The various reports published by the Local Health Council do not list petitioner as performing cardiac catheterization procedures. While a health care facility may obtain a written determination from HRS that a given service is exempt from Certificate of Need review due to its "grandfathered" status, there is no agency rule or policy which requires a facility to obtain such a written exemption. It has generally been the agency policy that equipment and services acquired by a facility prior to the date that such acquisition became reviewable under the Certificate of Need law are not reviewable on a retroactive basis.
