Conclusions THIS CAUSE comes before the State of Florida, Agency for Health Care Administration, (“the Agency”) regarding certificate of need ("CON") application number 10157 filed by Tallahassee Medical Center, Inc. d/b/a Capital Regional Medical Center (“CRMC”) and CON application number 10156 filed by Bay Hospital, Inc. d/b/a Gulf Coast Medical Center (*GCMC”). 1. CRMC filed a CON application which sought the establishment of a 12-bed comprehensive medical rehabilitation unit within its hospital located in Leon County, Florida, Service District 2. The Agency denied CRMC’s CON application 10157. 2. GCMC filed a CON application which sought the establishment of a 20-bed comprehensive medical rehabilitation unit within its hospital located in Bay County. Florida, Service District 2. The Agency denied GCMC’s CON application 10156. 3. Both parties filed a petition for formal hearing challenging the Agency’s denials of their respective CON applications. 4. Both parties have since voluntarily dismissed their petitions for formal hearing. 5. Based upon these voluntary dismissals, the Division of Administrative Hearings entered an Order Closing Files in the above styled matter. IT IS THEREFORE ORDERED: 6. The denial of CRMC’s CON application 10157 is UPHELD. 7. The denial of GCMC’s CON application 10156 is UPHELD. ORDERED in Tallahassee, Florida on thie 2 day of Crfebe_ . 2013. hob Py eclets Elizabeth Dudk, Secretary Agency for Health Care Administration
Other Judicial Opinions A party who is adversely affected by this final order is entitled to judicial review, which shall be instituted by filing the original notice of appeal with the agency clerk of AHCA, and a copy along with the filing fee prescribed by law with the district court of appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review proceedings shall be conducted in accordance with the Florida appellate rules. The notice of appeal must be filed within 30 days of the rendition of the order to be reviewed. CERTIFICATE OF SERVICE 1 HEREBY CERTIFY that a true and correct copy of the foregoing Final Order has been furnished by U.S. Mail or electronic mail to the persons named below on this f 3S day of /Voye—he/ . 2013. Richard J. Shoop, Agency Cler Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 (850) 412-3630 Janice Mills Facilities Intake Unit Agency for Health Care Administration (Electronic Mail) James McLemore, Supervisor Certificate of Need Unit Agency for Health Care Administration (Electronic Mail) James H. Peterson, IE] Administrative Law Judge Division of Administrative Hearings | (Electronic Mail) Lorraine M. Novak, Esquire Assistant General Counsel Agency for Health Care Administration (Electronic Mail) Stephen A. Ecenia, Esquire R. David Prescott, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Tallahassee, Florida 32302 Counsel for CRMC and GCMC (U.S. Mail) R. Terry Rigsby, Esquire Pennington, Moore, Wilkinson, Bell & Dunbar, P.A. 215 South Monroe Street, 2"! Floor Tallahassee, Florida 32301 Counsel for HealthSouth { (US. Mail)
Findings Of Fact Respondent, Randall B. Whitney, is a licensed medical doctor having been issued license number ME 000 8859 by petitioner, Department of Professional Regulation, Board of Medical Examiners. He presently resides in Port Orange, Florida and operates a family planning center in Daytona Beach. Respondent is a 1959 graduate of Tulane University Medical College. After interning at a Jacksonville hospital, he served three years in the U.S. Air Force as a flight medical officer and flight surgeon. He then took a two- year general residency in California. He began private practice in Mount Dora, Florida in 1965, the same year he received his license to practice in Florida. Although he was once board certified in family practice, he is not presently board certified in any specialty. He is not a member of the Florida or American Medical Associations and he does not hold privileges on the staff of any hospital. Prior to the initiation of this proceeding he did apply for emergency room privileges at a hospital in Daytona Beach but his application was denied. Therefore, he cannot admit patients to hospitals. When the events herein occurred, respondent had a financial interest in and was medical advisor to the Childbirth Center (CBC) in Daytona Beach. He also provided medical services on a contract basis to the Woman's Health Center (WHC) in Orlando and Holly Hill and the Aware Woman Clinic, Inc. (AWC) in Cocoa Beach. All four are birthing centers where women receive care and treatment during pregnancy and where the actual labor and delivery occur. Additionally, the facilities provide annual check-ups, IUD services, abortions, and advice for birth control. He divided his time between the four clinics, visiting each place one day of the week except the Orlando clinic, which he visited two days per week. In the spring of 1981, respondent became acquainted with one Eric Niederschmidt, an enlisted man stationed at Patrick Air Force Base who also worked weekends or nights at Aware Woman Clinic as an "assistant". Eric complained of pain in his knee from an internal knee derangement caused by stress and requested a pain medication to ease the pain. Whitney wrote several prescriptions for percocet between March and September, 1981. He also permitted Eric on several occasions to fill out the prescription pad, then bring it to him for review, and then sign the prescription. The evidence is conflicting as to whether respondent kept pre-signed blank prescription forms at the Aware Woman Clinic, which were later used by Niederschmidt to obtain drugs. Although respondent admitted he pre-signed such forms to a Department investigator during an interview in November, 1981, he denied he did so during the final hearing, and it is found the greater weight of credible evidence supports a finding that he did not. The CBC is not equipped to handle emergency situations or to care for "high-risk" pregnancies. Instead, it is designed to handle the routine low-risk pregnancy which has no complications. Indeed, the CBC has no internal monitoring devices, x-ray equipment or cesarean section devices, all of which are needed when complications in preqnancy set in. Its medical equipment consisted primarily of nitrous oxide and oxygen in large H-cylinder tanks with a nasal applicator mask, a fetal Doptone monitor to monitor for fetal heart tones, an Isolette to provide a controlled environment for babies distressed prior to transfer, outlet forceps, intracoths, emergency suction apparatus and the like. A supply of various kinds of medicine, including adrenalyn, ephedrine and pitocin were kept on hand. In 1979, one Joyce Ann Geeson became a patient of respondent at CBC. She was cared and treated for during her pregnancy in the months of June through a part of December, 1979. Around 3:30 a.m. on Saturday, December 8, 1979, Geeson awoke with ruptured membranes. She did not begin labor until almost 22 hours later. After labor pains commenced that night and early Sunday morning, Geeson reported to the CBC at noon on Sunday. After 38 hours of labor with little progress, Whitney ordered that pitocin be administered to Geeson. That drug serves to stimulate contractions of the uterus. However, this drug should only be used in a hospital setting since it can cause a tetanic contraction of the uterus and cut off the blood supply to the baby. It can also cause a rupture of the uterus. Therefore, it was inappropriate for Whitney to use pitocin in his facility. This is confirmed by instructions in the Physicians Desk Reference, 1979 edition, as to the use of the drug as well as uncontradicted expert testimony presented by petitioner. In Geeson's case the pitocin was continued for some 18 hours until a decision was made to transfer the patient to a hospital after the patient had made very little progress. Geeson was finally admitted to the emergency room at Halifax General Hospital around 11:10 p.m. on December 10, 1979. Whitney accompanied her to the hospital. When Geeson's temperature rose to 102.3 around 6:00 a.m. on December 11, she was immediately sent to the operating room where a C-section was performed. An examination of Geeson indicated her membranes had been ruptured for approximately 68 hours prior to admission to the hospital, that the patient had given signs of such a rupture by the excretion of a green tinged fluid (meconium), and that Geeson had stopped progress in delivering the baby some 24 hours prior to the hospital admission. Whitney's failure to recognize and properly handle premature rupture of the membranes, to promptly repond to meconium staining (which is a sign of possible fetal distress), and the use of pitocin in a non-hospitaL setting were deviations from the level of care, skill and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. Sandra Vigue was a 33 year old patient of the CBC in the fall of 1979. She first visited the clinic in her third trimester in September, 1979. Vigue told CBC personnel that her last menstrual period was mid-December, 1978 which would have indicated an expected date of confinement (EDC) of mid or late September, 1979. The clinic initially noted her EDC as being late September or early October. A nurse later noted in the records that on September 19 the patient was approximately 35 weeks gestation, or 5 weeks before the due date. When the baby had not come after weekly visits to the clinic in October, a nurse simply placed a question mark next to Vigue's EDC. By this time (42 weeks), according to expert medical testimony the fetus comes at high risk because of post-maturity syndrome. On October 21, 1979, Vigue began labor around 7:00 p.m. Around 8:30 p.m. a nurse noted the presence of a greenish substance being discharged in the vaginal area while performing an examination at Vigue's home. She noted in the patient records that it had the appearance of meconium. The nurse immediately telephoned respondent to report this finding. After a discussion, Whitney discounted the fluid as being cervical and not meconium. Meconium is, of course, an indication of fetal distress and that a membrane has prematurely ruptured. This in turn leads to a high-risk situation in terms of the delivery of the baby. Vigue remained at her home overnight and had no apparent progress in contractions. At approximately 1:00 p.m. the next day (October 22) Whitney requested she come to the clinic. She did so and was evaluated by him at 4:00 p.m. Whitney noted the passing of copious malodorous meconium and asked "why" in the charts. He then sent her to a local hospital where she was admitted at 7:50 p.m. the same day. Upon examination by hospital personnel, they noted premature rupture of the membranes and a discharge of meconium. Before further tests could be run, Vigue's condition deteriorated and she was given an emergency cesarean section. A stillborn infant was delivered. Respondent performed no post-maturity syndrome tests on Vigue that are normally given when a woman reaches an age of 42 weeks pregnancy. These tests are essential since a baby at that age may be under stress from lack of nutrients and oxygen. In this regard, he failed to conform to prevailing community standards for physicians. Vigue was apparently quite firm in not wanting her baby delivered in a hospital setting. However, a physician should advise the patient when high risks set in of the potential danger in not doing so, and if the patient refuses, document his records accordingly. Here, Vigue apparently held off until the last possible moment, but Whitney did not adequately document his records to show that he advised her of the potential dangers. Again, he failed to meet acceptable standards of skill, care and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. But since this was not a charge within the complaint, it is irrelevant. Finally, Whitney was negligent in the same respect by failing to recognize the meconium staining that occurred on October 21 and asking the patient for a history of rupture of membranes. In July, 1979, Lida Papa became a patient of CBC. Her estimated date of delivery had been established by CBC personnel as December 11, 1979. Papa suffered a ruptured membrane at 3:00 a.m. on December 22, 1979 or three full days prior to being admitted to a hospital. Her labor commenced on December 23. Because of slow progress, Whitney began administering pitocin to Papa around 7:25 p.m. on December 23 at a rate of 8 drops per minute, or a rate of 2 to 3 times that used initially in a hospital setting. The administering of the drug continued in larger dosages until the afternoon of December 24 when he allowed her to rest. It was restarted at 9:30 p.m. that evening and continued until 11:30 p.m. At the same time, the patient records of Papa reflect signs that the baby may have been in distress. She was also given ampicillin, presumably to counteract chills and fever being experienced around 1:30 a.m. on December 25. When her temperature reached 101 degrees Papa was sent to Halifax Memorial Medical Center, a Daytona Beach hospital. It was noted there that Papa had been at 9 or 10 centimeters dilation for some 18 to 19 hours prior to being transported to the hosptial. This is equivalent to complete dilation, and babies are normally delivered within two hours after complete or near complete dilation. Prudent medical care would have dictated that Whitney transfer Papa to the hospital no later than 24 hours after the membranes were ruptured if delivery had not occurred or was not imminent. This would have required admission to the hospital on December 23 rather than December 25. Whitney was also negligent in using pitocin in a non-hospital setting, and in dosages higher than is normally used. But this conduct was not described within the complaint and accordingly is irrelevant. Whitney failed to recognize that the patient was at high risk in a non-hospital setting because of the use of pitocin and the prolonged rupture of the membranes. In these respects, he deviated from the level of care, skill and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. Whitney was employed by the Women's Health Center, Inc. (WHC) in Orlando, Florida on a contract basis in 1978. He generally visited the Center either on Tuesday and Thursdays of each week, or Thursday only, depending on his schedule at other clinics. Whitney did not represent himself to the Center as being a urologist although he routinely performed vasectomy procedures. Daniel Hallman wished to have a vasectomy performed, and after searching through the Yellow Pages, selected the WHC. He talked by telephone with an unidentified lady at the Center and asked if the physician who would perform the vasectomy was a "licensed urologist." He was assured that Whitney was. Hallman then made an appointment to have the procedure performed on Thursday, November 16, 1978. On that afternoon, he visited the Center where he first saw a film on vasectomies which briefly touched on complications, procedures and care of patients. He had some preliminary work performed by a nurse and then met with Whitney. He was never advised by Whitney of the risks associated with the operation or complications that could result from the procedure. Whitney testified that although he normally counseled patients, he thought Hallman had "waived counseling in effect" because he was intelligent and seemed to be well-read on the subject. Whitney was not asked nor did he represent to Hallman that he was a "licensed urologist." After the procedure was performed, Whitney told Hallman he could not ride a bicycle to work for awhile and to avoid intercourse for several days. He did not tell him that swelling, bleeding and fever could occur. Hallman left, went home, slept and then awoke later that night with pain, swelling and bleeding. He called the Center and a nurse advised him to apply ice to stop the bleeding. He did so and went back to sleep. Later on, he awoke in extreme pain and noticed his scrotum had swollen to the size of a grapefruit. He again called the clinic asking for Whitney but was told Whitney lived in Cocoa Beach and was unavailable. The nurse told him to keep applying ice and he would be okay. When Hallman called a third time on Friday morning, the clinic then contacted Whitney who returned Hallman's call later that morning. Whitney told him he could see him if Hallman would drive to Cocoa. Whitney did not recommend he see another physician since he had no "back-up" in the area. Whitney advised Hallman to continue to apply ice and to see him when he visited the Center the following Tuesday. The following Tuesday, the two met and Whitney prescribed a pain killer (darvon), clipped a stitch and squeezed some dry blood out of the area. He noted it was the worst case of swelling he had ever seen. He also advised Hallman to take warm baths. The two never met again. When the pain killer became ineffective, Hallman contacted a urologist the following Saturday who treated him at the emergency room of an Orlando hospital. The physician found Hallman to have a low-grade fever and prescribed an antibiotic and pain killer. When the procedure was performed, Whitney had no local hospital privileges or a "back-up" physician to handle emergencies. Whitney testified he had no post-operative information to give to Hallman to read. He attributed the problem to a "nicked" varicose vein and stated that he has performed approximately 1,000 such operations routinely since 1965 without a patient ever being hospitalized. Had he considered there to be a danger of infection, he would have referred Hallman to an emergency room. Because Whitney had no back-up physician for Hallman to see should post-operative complications have arisen, he failed to meet the standard of care practiced by similarly prudent physicians in the community. The administrative complaint does not allege, and indeed there is no evidence, that the procedure was improperly performed. Respondent has safely delivered at least 1,000 babies during his medical career. He believed that Vigue, Papa and Geeson were carefully monitored and treated, and were timely transported to the hospital once their risk factors had escalated. In the case of Hallman, Whitney stated he would have seen the patient had he realized an emergency existed, and admitted him to an emergency room if necessary. He justified the use of pitocin on the grounds it was safely administered and the Physicians Desk Reference is not binding on physicians in all cases. Whitney no longer performs childbirths and is not associated with any of the clinics in question. Instead, he now confines his practice exclusively to family planning.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Subsection 458.331(t), Florida Statutes, on four occasions as more specifically set out above, and that his medical license be suspended for thirty days, a $2,500 administrative fine imposed, and that he be restricted from performing childbirths except in a hospital setting. All other charges should be dismissed. DONE and entered this 20th day of April, 1984, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of April, 1984. COPIES FURNISHED: Douglas P. Jones, Esquire John M. Bringardner, Esquire P.O. Box 2174 Tallahassee, Florida 32316 Jack R. Leonard, Esquire 800 North Highland Avenue Suite 202 Orlando, Florida 32803 Frederick M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The facts, as stipulated to by the parties and as set forth above, are hereby adopted.