Findings Of Fact Respondent Anila Poonai began her medical education in her native land, India, and, in 1960, she received a medical degree from Bombay University. After an internship in Bombay, she spent three months in training in the United Kingdom, before travelling to Georgetown, Guyana, to become a resident medical officer at the public hospital there. After two years in Guyana, she returned to England where, in 1964, she passed a post-graduate examination. As a result of a residency in obstetrics and gynecology and a satisfactory showing on the requisite examinations, she became a member, in 1969, of the Royal College of Obstetrics and Gynecology. All told, respondent has spent six years as a resident in obstetrics and gynecology. From England, she travelled to the University of the West Indies in Kingston, Jamaica. At the University of the West Indies, she was senior registrar in obstetrics and gynecology and, for six months, acting lecturer in obstetrics and gynecology. In 1973, she and her husband, who is a general surgeon, moved to Cleveland, Ohio. Respondent has not sought certification by the American College of Obstetrics and Gynecology. She testified that the American College of Obstetrics and Gynecology recognized her membership in the Royal College of Obstetrics and Gynecology as an equivalent certification. Until moving to Port St. Joe, she worked as a house physician in St. Alexis and Hillcrest hospitals in Cleveland. Respondent and her husband moved to Florida at the invitation of the Board of Trustees of the Municipal Hospital of Port St. Joe. The Board wanted to upgrade the Hospital. Almost from the time of their arrival, respondent and her husband found themselves at the center of controversy. Respondent's husband testified that, when he and respondent began work at the Municipal Hospital of Port St. Joe, in August of 1976, norms of practice at the Hospital were "miles below standard" and that the medicine practiced by other physicians in the community was "about 25 years" out of date. Whether true or false, this view, and its blunt articulation, may account for the friction respondent and her husband experienced in their relationships with some of the nurses and physicians with whom they came into contact. Being the only such specialist on the staff, respondent was named chief of obstetrics and gynecology at the Municipal Hospital of Port St. Joe. In this capacity, she ordered drugs and other obstetric and gynecologic supplies for the Hospital. Chief of staff at the Hospital, from 1961, until the spring of 1977, was John Wayne Hendrix, who has practiced medicine in Port St. Joe for some three decades. During Dr. Hendrix' tenure as chief of staff, Dr. Orr of Wewahitchka, a general practitioner, was granted "courtesy privileges" at the Municipal Hospital of Port St. Joe. At all pertinent times, Hospital bylaws forbade a physician to whom only courtesy privileges had been granted, to attend a delivery, except under the supervision of the chief of obstetrics and gynecology. On March 27, 1977, in violation of the Hospital's bylaws, Dr. Orr attempted, for the first and only time, to deliver a baby in the Municipal Hospital of Port St. Joe. When Gloria Pippin, R.N., arrived to begin the 3 to 11 shift, Dr. Orr's patient was already in labor. At 9:30 that night, the patient's cervix was fully dilated; at 9:45 she was taken to the delivery room. At 11:00 Dr. Orr "did a saddle block," i.e., he administered a spinal anesthetic. Five minutes later he had finished an episiotomy. At quarter past eleven, he used Tucker-McClain forceps in an effort to extract the baby. That failing, he tried long Simpson forcens at 11:25 and Kielland forceps at ten minutes before midnight, March 27, 1977. The baby's head was too big for the mother's pelvis. Five minutes later, Ms. Pippin telephoned respondent, at Dr. Orr's request. Respondent expressed dismay that Dr. Orr had been permitted to begin, and asked Ms. Pippin to notify Dr. Hendrix of the situation. She herself telephoned Gerald Sullivan, the chairman of the Hospital's Board of Trustees. Afterwards, she and her husband, Dr. Parmanand Vijay Poonai, went to the Hospital. They arrived at approximately 12:40. Dr. Hendrix, who had considerable experience in performing Ceasarean sections, preceded them to the Hospital. By the time the Drs. Poonai reached the hospital, arrangements had been made for Dr. Orr's patient to be transferred to Panama City's Bay Memorial Hospital. At quarter past midnight, when Dr. Hendrix arrived at the hospital, the mother's blood pressure was 134/78. Ten minutes before she left in the ambulance, her blood pressure was 137/98 and her pulse was 112. At that time, the fetal pulse was 156. At 1:20 a.m., an ambulance left the Municipal Hospital of Port St. Joe for Panama City. When they reached Bay Memorial Hospital, the mother's vital signs and the infant's heart beat were within normal limits. Dr. Stephen Smith, the obstetrician who performed a Caesarean section upon the patient's arrival in Panama City, was the man of the hour. Mother and baby did well. For many years, it has been common to send women in labor to Panama City from Port St. Joe, and hundreds have made the trip. It takes a half hour to an hour to drive from the Port St. Joe hospital to the Panama City hospital. The longer a woman in the condition Dr. Orr's patient was in continues in labor, the greater are the chances of injury or death to the fetus and even to the mother. At no time did Dr. Hendrix telephone respondent on the night of the 27th or morning of the 28th. Neither Dr. Hendrix nor Dr. Orr ever asked respondent for assistance with Dr. Orr's patient. When respondent and her husband arrived at the Hospital early on the morning of March 28, 1977, neither Dr. Hendrix nor Dr. Orr spoke to either of them. Dr. Hendrix refused to speak to them, even though respondent addressed him and asked him specifically about Dr. Orr's patient. Both respondent and her husband remained at the Hospital until after the ambulance left for Panama City. It is unethical for one physician to intervene in the care of a patient whose treatment is being actively managed by another physician, unless requested. It may also be dangerous. On January 16, 1978, Dr. P. V. Poonai saw Beverly R. Bass in his office. Ms. Bass, who was born on December 15, 1951, told Dr. P. V. Poonai that a Dr. Vasquez of Port St. Joe (of whose wife Ms. Bass was a cousin) and other physicians had recommended a hysterectomy; that she had been passing blood clots for the preceding four months; that she had epigastric pain; that her most recent menstrual period was December 19, 1977; that she had two daughters and a son by three different men; that she wanted no more children; and that she wanted a hysterectomy both to prevent conception and to stop her bleeding. After examining her and finding an ovarian cyst and a slightly bulky uterus, Dr. P. V. Poonai prescribed hospitalization for a series of gastrointestinal X-rays to investigate the possibility of an ulcer, and for an obstetric and gynecologic consultation with respondent. On January 18, 1978, Ms. Bass entered the Municipal Hospital of Port St. Joe. An electrocardiogram was done. Dr. J. B. Harbison prepared a report of the X-rays taken as prescribed by Dr. P. V. Poonai. Respondent met Ms. Bass for the first time, in the Hospital, on January 19, 1978. She took Ms. Bass' history and examined her under general anesthesia, finding a left ovarian cyst, a normal cervix and a bulky anteverted uterus. Respondent recommended a dilatation and curettage (d & c) for diagnostic and therapeutic purposes, and, on the same day, Ms. Bass signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a d & c. The following day, January 20, 1978, respondent did perform a routine d & c. Afterwards, the curettings resulting from the procedure were transmitted to a pathologist. After examining this material, the pathologist prepared a tissue report, and stated, as the pathological diagnosis: SECRETORY PHASE, DYSFUNCTIONAL BLEEDING. NO EVIDENCE OF POLYPS, PREGNANCY OR MALIGNANCY OBSERVED IN THE SPECIMEN SUBMITTED. FRAGMENT OF ENDOCERVIX WITH SQUAMOUS METAPLASIA, ACUTE AND CHRONIC INFLAMATION. Petitioner's exhibit No. 2. On January 21, 1978, Ms. Bass left the hospital, with a final diagnosis of dysfunctional bleeding. Before discharging Ms. Bass, respondent instructed her to refrain from sexual intercourse and from douches for four to six weeks. Eight to ten days after her discharge, Ms. Bass resumed sexual intercourse. On February 2, 1978, respondent saw Ms. Bass at her office and discussed the pathologist's tissue report with her. She related to Ms. Bass her clinical impression of uterine fibroids and prescribed Orthonovum, a birth control pill, as an additional means of forestalling dysfunctional bleeding. On February 2, Ms. Bass reported no bleeding subsequent to the d & c. Respondent did not ask and Ms. Bass did not volunteer that she had failed to follow instructions to abstain from sexual intercourse. Although the birth control pills respondent prescribed were to be taken daily, Ms. Bass did not take one every day. Respondent next saw Ms. Bass on February 13, 1978, when her only complaint was of an upper respiratory tract infection. On March 4, 1978, Ms. Bass returned to respondent's office complaining of heavy breakthrough bleeding, and reported that she was passing blood clots. Respondent examined her and suggested a hysterectomy. Ms. Bass asked if she could enter the hospital on March 12, 1978, saying she could make arrangements for her children by then. Respondent administered no pregnancy test to Ms. Bass on March 4, 1978, or at any time thereafter. She thought none was necessary because she believed that Ms. Bass had followed her instructions. Respondent does not knowingly perform abortions, even for therapeutic purposes, on account of religious scruples. A d & c elicits inflamatory responses hostile to fertilization. Even when a pregnancy has begun, no pregnancy test will be positive before 41 days have elapsed since the last menstrual period. Some hospitals, like Jackson Memorial in Miami, require pregnancy tests before surgery as a matter of routine, but the Municipal Hospital of Port St. Joe had no such policy. On March 12, 1978, Ms. Bass was admitted to the Municipal Hospital of Port St. Joe. The following day respondent performed a hysterectomy and an incidental appendectomy. An appendectomy ordinarily accompanies this procedure. Respondent's pre-operative diagnosis was "menorrhagia and fibroid uterus," and her postoperative diagnosis, on March 13, 1978, was unchanged. This was the same condition specified on the form consent to diagnostic and treatment procedures which Ms. Bass signed on March 12, 1978, authorizing respondent to perform a hysterectomy. Ordinarily, a surgeon performing a hysterectomy removes the uterus intact, as respondent did in the case of Beverly Bass. After its removal but while still intact, Ms. Bass' uterus yielded no additional information pertinent to the diagnosis of her condition. The uterus was sent to a pathologist. After examining the uterus, the pathologist prepared a tissue report and stated, as the pathological diagnosis: APPENDIX WITH FIBROUS OBLITERATION (DISTAL) AND FOCAL FIBROUS ADHESIONS. LUTEAL CYST OF LEFT OVARY, BENIGN. PARATUBAL CYST, BENIGN, RIGHT. ENLARGED UTERUS (205 GMS) WITH: ENDOMETRIUM: CHANGES RELATED TO PREGNANCY (HYPERSECRETORY GLANDS AND DECIDUAL REACTION). ACUTE ENDOMETRITIS. ANGULAR IMPLANT OF PLACENTA ASSOCIATED WITH UNDERLYING NECROSIS AND ACUTE INFLAMMATION OF DECIDUA, ACCOMPANIED BY HEMATOMAS. CHORION-AMNIONITIS, ACUTE, NECROTISING ASSOCIATED WITH NECROSIS OF GROUPS OF CHORION VILLI. EMBRYO, APPROXIMATELY 4-6 WEEKS OLD. FLUID BLOOD PRESENT IN UTERINE CAVITY. MYOMETRIUM: HYPERTROPHY (FUNCTIONAL). CERVIX: ACUTE AND CHRONIC CERVICITIS ASSOCIATED WITH SQUAMOUS METAPLASIA OF THE ENDOCERVICAL LINING, FOCAL. SQUAMOUS CELL HYPERPLASIA OF ECTOCERVIX, BENIGN. MUCUS CYSTS. When the pathologist opened the uterus, he found an enlarged cavity partly occupied by a ruptured ovisac. Extruded through the perforation, hanging outside of the ovisac from the umbilical cord, was an embryo 1.8 centimeters long. The placenta, which was acutely inflamed, adhered to the fundus at a right angle. Uterine rupture is inevitable if an angular pregnancy continues, but it is possible for an angular pregnancy to go to term, just as it is possible for a fetus to live after the ovisac has burst. In Ms. Bass' case, however, the embryo was probably non-viable at the time of the hysterectomy. The pathologist's report arrived while Ms. Bass was still in the hospital. Because respondent was upset on reading it, she asked Dr. P. V. Poonai to tell Ms. Bass what the pathologist had learned. Dr. P. V. Poonai did tell Ms. Bass, at which time she confirmed that she had engaged in sexual intercourse shortly after the d & c. Confusing an incipient pregnancy with a fibroid uterus is an occasional mistake any physician could make. An isolated mistake of this kind does not constitute a deviation from acceptable medical practice. The most conservative approach is to wait for two months after the patient has stopped taking birth control pills, before performing a "semi-elective" procedure, and to administer a pregnancy test beforehand. Several physicians testified, however, that they would not have ordered a pregnancy test before performing a hysterectomy in the circumstances of Ms. Bass' case. Respondent did not prepare the summary sheet at the end of Ms. Bass' stay after her March 12, 1978, admission, Chart No. 23622. Petitioner's exhibit No. 2A. The summary sheet that was prepared is not signed by anybody. When respondent asked for the chart in order to prepare a summary sheet, the Hospital's records custodian advised her that it was not with the other charts. When Beverly D. Stover was about three and a half months pregnant, she began seeing respondent. She saw her every month until November, when she began seeing her every two weeks. On her first visit, she told respondent she wanted to be sterilized after the birth of the child she was carrying, her second. At respondent's request, Mrs. Stover brought her husband to respondent's office, about six weeks before the baby was born. The three of them discussed Mrs. Stover's planned sterilization. On November 22, 1977, both Mr. and Mrs. Stover signed a form request for sterilization witnessed by two persons who were not called to testify at the hearing. On November 30, 1977, Mrs. Stover was admitted to the Municipal Hospital of Port St. Joe. On the day of her admission, she signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a bilateral tubal transection and ligation, and both she and her husband signed another form request for sterilization. At the time of the signing of the last two documents, Mrs. Stover told Sarah Maddux, the nurse who gave her the forms to sign, that she did not want to be sterilized unless her baby was normal. Ms. Maddux never relayed this oral reservation to respondent. It is impossible to tell, at the time of birth, whether an infant has a sense of smell, whether it is intellectually impaired, or whether it can see or hear. At 1:50 on the afternoon of November 30, 1977, Mrs. Stover was delivered of a daughter, Katrina. Respondent examined the eight pound two ounce infant for two minutes. She put her fingers in the infant's mouth, cleared a passage for air, and checked for a cleft palate. The child started crying. Respondent observed good muscle tone. Respondent clamped, then cut the umbilical cord. She inspected the baby all over, noticed puffiness on the child's back, which she attributed to the trauma of birth, and noticed that the baby's anal opening was smaller than normal, but was not alarmed. She thought she had seen even smaller such openings which had not affected function. Respondent placed Katrina on her mother's stomach, and asked Mrs. Stover whether she was ready for surgery. When Mrs. Stover answered affirmatively, at 1:55, anesthesia was administered, at respondent's direction. A nurse took the baby from respondent for cleaning. In contemporaneous notes, the nurse described the baby as apparently normal. In fact, Katrina had an imperforate anus or anoperitoneal fistula, and a lipoma on the sacral area of her back. These conditions were discovered a few hours later by a nurse in the Hospital nursery. The nurse brought both problems to the attention of Dr. Shirley R. Simpson, a physician who had been on the staff of the Municipal Hospital of Port St. Joe for approximately ten years and who happened to be in the Hospital at the time. Respondent had left Port St. Joe to meet her husband at the airport in Panama City. Examining Katrina at the nurse's request, Dr. Simpson mistook the lipoma for a meningomyocele. Dr. Simpson took no further action in the case, other than leaving word with the nurse for respondent to call her, until she furnished the Board of Medical Examiners Katrina's hospital chart. By that time, somebody had forged an entry in the nurse's notes for 1:50 P.M. on November 30, 1977, viz., "Appears to have NO rectal orifice-Dr. A. Poonai notified." Petitioner's exhibit No. 4. After her return from Panama City, on December 1, 1977, respondent correctly diagnosed the lipoma. At respondent's request, Dr. P. V. Poonai examined Katrina. After obtaining consent, Dr. P. V. Poonai, used surgical implements, when the baby was 16 hours old, to remove the obstruction which had prevented the expulsion of all but the merest drop of meconium during the first 16 hours of the baby's life. Although this emergency procedure solved the immediate problem and allowed the baby to defecate, further surgery has been necessary to move the anal opening to its norman site posterior of the dimple where Dr. P. V. Poonai made his incision. An imperforate anus occurs once in 5,000 births. The imperforation may or may not be visible, depending on its location. In the past five years, three infants with this problem have been born in Panama City. In each instance, the examining pediatrician did not discover the imperforation, which came to light some hours after birth, on account of the baby's failure to expel its first stool. In Katrina's case, however, the abnormality could be seen and its existence could be confirmed by an attempt to probe. The lipoma on Katrina's back measured less than four by five centimeters in area. It was a soft, skin-colored mass of benign, fatty tissue, which a pediatric surgeon has since removed. The trauma of birth sometimes causes edemas that resemble lipomas. No harm befell Katrina as a result of respondent's failure to diagnose either her lipoma or her anal abnormality at birth. Beverly Stover continued as a patient of respondent for some time after Katrina's birth. Respondent first saw a certain patient on September 19, 1977. This patient, who was born on June 1, 1907, suffered from diabetes mellitus and congestive heart failure, among other things. Two months earlier she had had a second pacemaker inserted. On her first visit to respondent, the patient complained of pain in her chest and of dysuria. She said she had difficulty retaining urine, but that she was unable to empty her bladder completely. In examining her, respondent discovered a moderate cystocele, which is a herniation of the bladder into the vagina. Respondent admitted her into the Municipal Hospital of Port St. Joe for treatment of her congestive heart failure, the cause of the chest pain. Congestive heart failure is not a disease of which people are cured, but it is a condition that may grow better or worse. When this patient's condition improved, respondent sent her home. Respondent saw her again in her office on October 3, 1977, when she complained of paroxysmal dyspnea and swollen feet. Respondent diagnosed superimposed congestive cardiac failure and prescribed a diuretic. On November 18, 1977, respondent admitted her to the hospital because symptoms like those she had complained of during the office visit persisted. On November 22, 1977, she was discharged. A similar episode resulted in rehospitalization from January 10, 1978, through January 19, 1978. The patient entered the hospital again, on February 12, 1978, with congestive cardiac failure. She complained about nocturnal incontinence and asked respondent to correct her bladder problem. At this time, respondent described the cystocele as large. After medical care which petitioner's own witness described as excellent, the patient's condition stabilized. Respondent testified that, in her judgment, the patient's general condition just before surgery was as good as it was likely ever to be. Nine days after she admitted the patient, respondent effected a repair of the cystocele by performing an anterior colporrhapy under local anesthetic. This procedure requires unusual surgical skill, and most surgeons do not attempt it. The repair of a cystocele is a therapeutic measure. In the absence of treatment, urine is likely to stagnate in the herniated portion of the bladder, and become a source of possibly serious infections. All surgical techniques for repairing cystoceles, other than the one employed by respondent, require general anesthesia. The risk from anesthesia to which respondent's patient was subjected was very moderate compared to the risk from general anesthesia. It was the same risk a person faces whose mouth is numbed by local anesthesia before a tooth is filled. Respondent had performed this operation 20 or 30 times before, and had performed it on her own mother, who was 75 years old and suffered from myocardial ischemia at the time. Sometimes, although decreasingly in recent years, a physician may employ a pessary as treatment for a cystocele. A pessary is a rubber or plastic solid that can be inserted in the vagina as a support for the intruding bladder. This is only a temporary measure, however, and involves a high risk of infection, which is the principal danger the cystocele itself poses. Respondent testified that her prescription for temporary relief was bed rest, since lying flat relieves the pressure that forces part of the bladder into the vagina. Respondent first saw another patient, the 29 year old mother of three children, on December 23, 1976. This patient was in the Municipal Hospital of Port St. Joe at the time, for a hemorrhoidectomy, and respondent was called in because the patient had complained of profuse, irregular and painful vaginal bleeding over a period of several years, and particularly during the preceding nine months to a year. The patient was anemic, according to tests run two days earlier. In July of 1976, the patient had been hospitalized on account of pelvic sepsis and bleeding. At that time, Dr. Simpson told her she would need a hysterectomy in the near future. She had been hospitalized for the same reasons in 1975. Respondent ordered a pap smear and an X-ray to locate a coil that had been inserted into the patient's uterus, as a contraceptive measure. When she recovered from the hemorrhoidectomy, the patient was discharged. After three weeks of severe menorrhagia, including two final days of heavy clotting, the patient was readmitted, on January 24, 1977, to the Municipal Hospital of Port St. Joe. Respondent had earlier prescribed iron pills. Perhaps as a result, the patient was no longer anemic. Respondent observed the patient's uterus "enlarged to about 10 weeks size with [what she thought was] fibroids. Petitioner's exhibit No. 6. Respondent ordered no pregnancy test. When an intrauterine device is in place, excessive vaginal bleeding is inconsistent with a viable pregnancy. An intrauterine device not only irritates the wall of the uterus, making conception unlikely, but also operates to abort incipient pregnancies, in the event of conception. With the intrauterine device still in place, on January 26, 1977, respondent performed a total abdominal hysterectomy and an incidental appendectomy, with conservation of both ovaries. Afterwards, the appendix, part of the cervix, and the uterus were sent to a pathologist. The pathologist examined these materials, and, on January 31, 1977, prepared a tissue report, in which he stated as the pathological diagnosis: APPENDIX WITH SEROSAL FIBROSIS, FOCAL (INCIDENTAL). ENDOMETRIUM: DECIDUA WITH EXTENSIVE NECROSIS ASSOCIATED WITH CHORIONIC VILLI (PREGNANCY) WHICH ARE LARGELY NON-VIABLE. SECRETORY ENDOMETRIUM WITH ACUTE AND CHRONIC ENDOMETRITIS. MYOMETRIUM: HYPERTROPHY, POSTERIOR. CERVIX: CHRONIC ENDOCERVICITIS AND MUCUS CYSTS. SLIGHTLY HYPERTROPHIC UTERUS (95 GRAMS). The pathologist found no evidence of fibroids. This demonstrates that respordent's clinical diagnosis of fibroids was inaccurate. One of the pathologists who routinely examined tissue removed by surgeons in the Municipal Hospital of Port St. Joe, Dr. Garcia-Rios, also routinely examined tissue removed by surgeons in other hospitals. Whenever a tissue report indicated disagreement between a clinical diagnosis and the pathological diagnosis, Dr. Garcia-Rios designated the tissue report "Code 3." The frequency of Code 3 tissue reports did not differ as between specimens removed by respondent and specimens Dr. Garcia-Rios examined which had been removed by other surgeons, taken as a group. From the presence of morphologically viable chorionic villi, the pathologist concluded that the patient had been pregnant. From pathological findings alone, he was unable to determine whether the pregnancy had terminated weeks or months earlier; or whether an ongoing microscopic pregnancy was interrupted by the hysterectomy. (Clinical evidence-excessive bleeding-ruled out the possibility of a viable pregnancy.) The pathologist's findings were consistent with, but did not conclusively establish the existence of, a placental polyp. Placental polyps may cause prolonged bleeding. Before surgery, respondent discussed three options with this patient: removal of the intrauterine device, removal of the intrauterine device followed by a d & c, and hysterectomy. The patient said that the presence or absence of an intrauterine device had made no difference in her bleeding problem in the past. She also told respondent that she wanted no more children, and that she wanted prompt, definitive treatment for her bleeding. After listening to explanations from respondent about the available options, the patient chose a hysterectomy. Respondent did not tell her that a hysterectomy was the only way to correct her problem. The patient testified that she has had no problems since her surgery; and that, knowing what the pathologist's tissue report subsequently revealed, she would make the same choice again, at least if it would not involve her as a witness in legal proceedings. Respondent initialled a summary sheet in the patient's chart, which stated the patient's final diagnosis as, inter alia, "FIBROID UTERUS [and] MENORRHAGIA." This final diagnosis fails to take the pathologist's tissue report into account, even though the tissue report routinely becomes part of the chart and presumably was available to respondent at the time she initialled the summary sheet. Respondent testified that she initialled this summary sheet as one of a group of documents, and that she did not read it beforehand. Any discrepancy between the tissue report and the final diagnosis would have been apparent to a knowledgeable reader. Without the tissue report, respondent would not necessarily have known that the pathologist's findings had demonstrated the error of her diagnosis of fibroid uterus. After controversy about this case arose, respondent caused an addendum to be prepared and incorporated into the chart, on August 16, 1978, and amended the discharge diagnosis to state, inter alia: "Menorrhagia, Chronic endometritis [and] Hypertrophy of the myometrium." This diagnosis is consistent both with respondent's clinical findings and with the pathologist's tissue report. In stating her amended discharge diagnosis, respondent took the tissue report, which had been incorporated into the chart, into account. This amended discharge diagnosis was not shown to be erroneous. On August 11, 1976, respondent saw Linda Whitfield for the first time. She came as a patient to respondent's office and related that her last menstrual period had taken place on June 26, 1976. Respondent examined her, observed a uterus of six weeks' size, and diagnosed early pregnancy. Respondent next saw Mrs. Whitfield in the emergency room of the Municipal Hospital of Port St. Joe on August 27, 1976, when her uterus looked to be of eight weeks' size. There Mrs. Whitfield told respondent that, while driving a tractor earlier in the day, she had experienced abdominal cramps and fairly heavy bleeding. Mrs. Whitfield did not report and respondent did not observe the passage of a fetus. Respondent diagnosed a threatened abortion (miscarriage) admitted Mrs. Whitfield to the Hospital, ordered bed rest, ordered that Mrs. Whitfield's urine be tested for the presence of chorionic gonadotropin, and prescribed an intramuscular injection of two cubic centimeters (cc.) of Depo-Provera (Upjohn's registered trademark for sterile medroxyprogesterone acetate suspension, U.S.P.). Although respondent did not specify the strength, she had ordered the Hospital's entire supply of Depo-Provera, and knew that the only strength on hand was 100 milligrams per milliliter. Depo-Provera is a synthetic progestational agent in an oily base. It has been commercially available for approximately 15 years. The 1971 Physicians' Desk Reference (PDR) reported that daily doses were indicated in the event of a threatened miscarriage. The 1972 PDR reported pregnancy as a contraindication for the use of Depo-Provera. (In 1972, respondent lived in Jamacia.) The 1976 PDR and the 1977 PDR, however, contain neither indications nor contraindications for Depo-Provera, in the event of pregnancy. The 1979 PDR reports pregnancy as a contraindication for the use of Depo-Provera. The phrase "missed abortion" describes the situation where a non- viable fetus remains in its mother's uterus. "Missed abortion" was named as a contraindication for Depo-Provera in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield. The contraindication of Depo-Provera for missed abortion reflected the view, generally shared in the medical community for many years but now rejected, that Depo-Provera acts to prevent uterine contractions and so make fetal expulsion less likely. The only indication stated in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield, was "[a]djunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma." Petitioner's exhibit No. 12B. Also on petitioner's exhibit No. 12B, under the heading "ADVERSE REACTIONS," is the statement: There is inferential evidence supporting the existence of an association between the administration of progestins early in pregnancy and the occurence of congenital malformations (see also WARNINGS). The referenced warning stated that "[u]sage in pregnancy is not recommended because of data indicating a possible association between administration of progestins early in pregnancy and congenital heart defects in the offspring." Petitioner's exhibit No. 12B. Mrs. Whitfield bled, off and on, during her first stay in the Hospital under respondent's care, until two or three days before her discharge. Because Mrs. Whitfield was bleeding on August 28, 1976, respondent prescribed an intra- muscular injection of one cc. of Depo-Provera. Altogether, respondent prescribed 1100 milligrams of Depo-Provera for Mrs. Whitfield over a 16 day period. She ordered administrations of two cc. doses of Depo-Provera on September 2, 1976, on September 4, 1976, on September 7, 1976, and on September 11, 1976, the day Mrs. Whitfield was discharged. At that time, respondent was hopeful that the pregnancy had been saved. At the time respondent prescribed Depo-Provera for Mrs. Whitfield, she believed she was aware of the inferential evidence referred to in the adverse reaction portion of petitioner's exhibit No. 12B. The evidence of which respondent was aware was the result of a retrospective study involving 10,000 mothers who took various hormonal substances during pregnancy and 10,000 mothers who did not. The number of deformed children born to mothers who had taken the hormonal substances exceeded by two percent the number of deformed children born to the mothers who had not. At the time she prescribed Depo-Provera for Mrs. Whitfield, respondent was one of a considerable number of physicians who believed that this drug could supply a hormonal deficiency that a woman faced with a threatened abortion (miscarriage) might lack, and which might be causing premature uterine contractions. Respondent weighed Depo-Provera's possibly teratogenic effect against its possibly ameliorative effect and made a conscientious professional judgment to prescribe Depo-Provera for Mrs. Whitfield. The 1971 PDR specifies a dosage of 50 milligrams day for threatened abortion, as long as symptoms persist. No dosages for threatened abortion are specified in the 1976 PDR, the 1977 PDR or on petitioner's exhibit No. 12B, the literature that accompanied each vial of Depo-Provera. When used to treat "inoperable, recurrent and metastatic endometrial carcinoma," Depo-Provera is prescribed in doses of 100 to 1000 milligrams at intervals of one week to one month. No evidence adduced at the hearing suggested that Depo-Provera has any known or suspected toxic effect on the mother, regardless of the dosage. Nor was it shown to have been scientifically established that Depo-Provera has had an adverse effect on any fetus, when administered to the mother, regardless of the dosage. It is no longer used in the case of threatened miscarriages because recent evidence suggests that it is inefficacious for this purpose. Outside of the United States, Depo-Provera is used as a contraceptive. While Mrs. Whitfield was in the Hospital, on August 29, 1976, respondent ordered a blood serum test to determine the level of chorionic gonadotropin. The results of this test, which respondent saw for the first time on September 16, 1976, were 6,554 milliunits of chorionic gonadotropine per milligram of test fluid. On September 16, 1976, Mrs. Whitfield came to respondent's office and complained of additional bleeding. At that time, a two minute slide test for pregnancy was performed, with negative results. Respondent examined Mrs. Whitfield and concluded that her pregnancy had miscarried despite the efforts to preserve it. She was admitted to the Municipal Hospital of Port St. Joe on September 17, 1976, with the diagnosis of "incomplete abortion," which was changed to "missed abortion," as the pre-operative diagnosis. On the day of her admission, additional pregnancy tests were ordered. A two minute test was negative, but a two hour test was positive. Every pregnancy test is fallible to some extent. These test results did not alter respondent's clinical judgment that the pregnancy had miscarried. A pregnancy test of a urine specimen can yield positive results from four days to two weeks after a pregnancy ends, and sometimes even later. It was undisputed that a result on a blood serum test for chorionic gonadotropin of 6,554 milliunits per milliliter virtually rules out a viable pregnancy of two or three months' duration, although the level may fall that low after the fifth month of a normal pregnancy. At eight to ten weeks, normal levels range from 46,000 to 60,000 milliunits per milliliter. Respondent performed a routine d & c on September 18, 1976. Fifteen grams of the resultant curettings were transmitted to a pathologist who reported "products of conception," but no embryo. Port St. Joe is not a prosperous town. At the time of the hearing, respondent and her husband were the only physicians in Port St. Joe who accepted patients on medicaid. Respondent has admitted patients approximately 500 times to the Municipal Hospital of Port St. Joe. During her time in Port St. Joe, respondent has treated numerous medicaid patients, and has delivered 249 babies. In one instance there was a neonatal fatality. This record compares favorably with a national average on the order of 12 neonatal fatalities per 1,000 births. Respondent has three articles in respectable technical journals to her credit, including two in "Obstetrics and Gynecology." On one she collaborated with her husband. They received 168 requests for reprints from interested persons in some 15 countries. The other article in "Obstetrics and Gynecology" she co-authored describes the first documented full-term pregnancy of a woman with diabetes mellitus, Addison's disease, and hyperthyroidism. The patient described in the article was under respondent's care for the duration of her pregnancy, which eventuated in a normal delivery.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner dismiss counts one, two, four, five and six of the administrative complaint. That petitioner reprimand respondent for her failure to diagnose the imperforation at the time of birth, in violation of Section 458.1201(1)(m), Florida Statutes (1978 Supp.), as alleged in count three of the administrative complaint. That, in all other respects, petitioner dismiss count three of the administrative complaint. DONE and ENTERED this 15th day of November, 1979, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 904/488-9675 COPIES FURNISHED: Clifford L. Davis, Esquire 197 South Bronough Street Tallahassee, Florida 32301 J. Ben Watkins, Esquire Post Office Drawer 1814 Tallahassee, Florida 32302 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS IN RE: The License to Practice Medicine as a Physician of: CASE NO. 79-1144 ANILA POONAI, M.D. License No. 27070 /
The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Howard E. Gross, M.D., based on allegations that he violated Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1971 and issued license number ME 0017039. Respondent has never been disciplined previously. Respondent is board-certified in internal medicine (1970) and cardiovascular diseases (1973). He is an interventional cardiologist. He has practiced medicine in Orlando since 1971. For the past 10 years, he has done a high-volume catheterization practice. In the most recent one-year period, he did approximately 500 interventional procedures and 400 diagnostic procedure, and in almost all instances, the catheterization involved a ventriculogram. On or about February 18, 1997, patient L. D. L., an 84-year-old male with a history of coronary artery disease, presented to Orlando Regional Medical Center, for catheterization and possible rescue angioplasty to be performed by Respondent. Respondent performed a cardiac catheterization on the patient. During the catheterization procedure, Respondent advanced a 6-French pigtail catheter into the patient's left ventricle and performed a ventriculogram by injecting what he thought was approximately 20cc of ionic dye, utilizing a MEDRAD injector. During the catheterization procedure, Respondent noted that he did not obtain opacification of the left ventricle and noted that free air was in the left ventricle. In fact, Respondent injected the patient with approximately 15cc to 20cc of free air rather than dye. As a result, the patient suffered cardiac arrest, and his blood pressure fell to zero. Respondent initiated various life-saving measures to counter the effects of the injection of free air, which were unsuccessful, and the patient was pronounced dead at approximately 1:55 p.m., as a result of cardiac arrest brought on by an air embolus. At the time, Orlando Regional Medical Center (hereinafter "ORMC") had a policy/procedure (No. 3233-MEDRAD- 0001) for Cardiac Catheterization Laboratory (hereinafter "Cardiac Cath Lab") personnel (Respondent's Exhibit 1). It delineated specific procedures to ensure "the use and safe applications of the power injector." In particular, it states the procedure to be employed by Cardiac Cath Lab staff in loading the MEDRAD injector. At ORMC and other hospitals, Cardiac Cath Lab personnel load the MEDRAD injectors without physician supervision. As explained by both expert witnesses, loading the syringe with dye is a very simple task for a nurse or scrub tech to perform. In the instant case, the nurse loading the MEDRAD injector interrupted the loading procedure because she was concerned about the patient's lab values (kidney function) and was uncertain about what type of dye Respondent would order. Respondent was not yet in the Cardiac Cath Lab. The nurse anticipated asking Respondent which type of dye he wanted and then loading that type dye into the MEDRAD injector. When she interrupted the loading procedure, the nurse left the plunger positioned in the syringe where it appeared that the syringe had been loaded with 20 to 25cc of dye and the injector arm pointing upward. The nurse then left the Cardiac Cath lab to get her lead apron anticipating only a monetary absence from the lab. Unknown to her, Respondent entered the Cardiac Cath Lab within seconds after her departure. Respondent was not in the Cardiac Cath Lab at any time while the nurse was manipulating the MEDRAD injector. As the nurse secured her lead jacket, she was called to another patient to administer medication which required the presence of a registered nurse per hospital procedures. In the nurse's absence, the catheterization and ventriculogram of the patient proceeded. The Registered Cardiovascular Technician (hereinafter "RCT"), observing the MEDRAD injector in what appeared to be a prepared state, wheeled it to the patient's side and lowered the injector arm into a position to receive the catheter. The RCT testified that a MEDRAD injector would never be left as she found it, plunger at the 20 to 25cc mark and arm elevated, if the machine was not loaded with dye. The ionic dye used in the procedure is clear and, due to the nature of the MEDRAD plunger and casing, it is extremely difficult to tell if dye is in the syringe. Further compounding the difficulty in observing dye in the syringe is the fact that the lights in the Cardiac Cath Lab are lowered during the procedure to allow better visualization of the video monitor. While the RCT positioned the MEDRAD injector at the patient's side, Respondent was in the process of entering the catheter into the patient, manipulating the catheter in the patient, visualizing its position in the patient's heart on the video monitor and monitoring hemodynamics. Petitioner's expert witness testified that Respondent did justifiably rely on the Cardiac Cath Lab personnel to follow the procedure outlined in Respondent's Exhibit 1. The nurse and cardiovascular technician did not follow the policy/procedure and, as a result, allowed the presence of air in the MEDRAD injector. After the catheter is properly located in the patient's heart, the external end of the catheter is attached to the MEDRAD injector. Petitioner's expert witness opined the Respondent should have used extension tubing to effect the connection between the catheter and MEDRAD injector. Testimony revealed that extension tubing is used by many physicians who perform cardiac catheterization. Respondent's practice was not to use extension tubing. Both Petitioner's and Respondent's expert witnesses agreed that Respondent's choice not to use extension tubing was a "technique" choice and did not fall below the "standard of care." Petitioner's expert opined that Respondent should have been present in the Cardiac Cath Lab to observe the loading of the MEDRAD injector. Testimony revealed that at ORMC and other hospitals it was the Cardiac Cath Lab staff's responsibility to load the MEDRAD injector without the direct supervision of physicians and that physicians are rarely in the lab when the MEDRAD injector is loaded. The "standard of care" does not require the physician to watch the loading of dye or the expulsion of air from the syringe in the loading process. Petitioner's expert opined that Respondent should have performed a test injection (a process where a small amount of dye is injected into the heart prior to the main injection). Respondent's expert testified that under certain circumstances (none of which is applicable to the instant case) test injections were appropriate; those circumstances occur less than 5 percent of the time. Electing not to perform a test injection in the instant case does not fall below the "standard of care." Petitioner's expert opined that Respondent should have observed a "wet to wet" connection between the catheter and the MEDRAD injector to ensure that no air is in the system. This is accomplished by withdrawing a small amount of blood from the catheter into the MEDRAD injector. Small air bubbles may appear between the blood and dye and are then "tapped" to rise to the top of the syringe. However, Respondent performed the "wet to wet" connection and did not observe anything unusual. He has historically performed some "wet to wet" connections where no air bubbles were present between the blood and dye as it appeared in this case. The RCT confirmed that Respondent performed the "wet to wet" connection, looked for air in the syringe, and tapped on the syringe to loosen and expel air bubbles. Respondent's expert witness testified that he performed an experiment creating a "wet to wet" connection with air in the MEDRAD injector syringe instead of dye. He found that the miniscus formed by blood and air in the syringe has an identical appearance to blood contacting dye in the syringe. The "wet to wet" connection between blood and air in the syringe has the same appearance as a "perfectly clean", "wet to wet" connection between blood and dye in the syringe. Respondent's expert witness testified that from five to ten percent of the time a "perfectly clean", "wet to wet" connection occurs in which no air bubbles appear between the blood and dye. Petitioner's expert witness testified that the physician must make absolutely certain that no gross amount of air is injected into the patient, and, relying on his view that the Respondent as the physician was the "captain of the ship," he testified that "the injection of this volume of air during the ventriculogram fell below the cardiology "standard of care." Petitioner's expert rendered his opinion based upon his examination of the hospital records. Respondent's expert rendered his opinion based upon his examination of the following: Administrative complaint with supporting documents. Dr. Allen Seals' (Petitioner's expert) report and deposition. Agency for Health Card Administration investigative report. ORMC's Code 15 report. Respondent's February 21, 1997 memo for peer review purposes. Hospital records. Death résumé. ORMC's MEDRAD policy/procedure. Experimentation with a catheter and MEDRAD injector. Respondent's expert testified that Respondent met the standard of care in the instant case because he practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. Based on the totality of the evidence presented, the undersigned rejects the expert opinion of Dr. Allen Seals, M.D., Petitioner's expert witness, and accepts as being more credible the testimony of David P. Browne, Jr., M.D., Respondent's expert witness.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order finding that Respondent is not guilty of violating Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint. DONE AND ENTERED this 13th day of February, 2001, in Tallahassee, Leon County, Florida. JEFF B. 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 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of February, 2001. COPIES FURNISHED: Ephraim D. Livingston, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Robert D. Henry, Esquire Martin D. Buckley, Esquire Ringer, Henry & Buckley, P.A. Post Office Box 4922 Orlando, Florida 32801-4229 Tanya Williams, Executive Director Department of Health Board of Medicine 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703
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 At all times pertinent to the issues involved herein, Respondent was licensed as a registered nurse in the State of Florida under license number 01271-2. Respondent has been licensed as a registered nurse in Florida since 1951. Since that time she has taken various continuing education courses in the nursing profession and is up-to-date on her continuing education requirements. She began work as a registered nurse with Methodist Hospital in 1967 and remained there until she was terminated 15 years later in December, 1982. According to Mrs. Scott the patient in question here, Mrs. Thornton, was first assigned to her care on the morning of November 26, 1982. This was the first day she met her. Respondent came into Mrs. Thornton's room that morning to get the patient up and ready for the day. At this point, Mrs. Thornton said she did not feel well and was very weak. Instead of a bath, she asked merely for a light sponge bath. The patient was wearing a high-neck "granny flannel" gown which she would not allow the Respondent to remove even to give her the sponge bath. At that time, Mrs. Scott says, Mrs. Thornton had one IV tube connected to an Abbott pump. This IV was connected to the patient's right forearm. Mrs. Scott did not see nor did she know that Mrs. Thornton had a subclavian catheter installed. Mrs. Scott contends that when she did rounds with Dr. Eye in the afternoon of November 26, he advised her to discontinue the IV in Mrs. Thornton's arm because of puffiness of the arm where the IV was connected. When she went to do that, she states she noticed one suture on the inside of the patient's right arm just above the elbow which was not connected to the IV. She showed this to Dr. Eye, who told her to take it out. As a result, she removed the suture and took out the intravenous tube from the right arm. At this point, she asked Dr. Eye if he wanted to send it to the lab and he said no. As a result, she put the IV set and all other throwaways in the wastebasket. At this point, Dr. Eye gave her an oral order to apply warm compresses to the arm. This order was subsequently reduced to writing. Mrs. Scott categorically denied having removed a left subclavian catheter from Mrs. Thornton. In fact, because of the gown Mrs. Thornton was wearing, Mrs. Scott denies even knowing that such a catheter had been installed. In any case, she would not have removed it by herself, she says, because she had been taught never to remove a subclavian catheter without someone else being present. She contends the catheter she removed was not a CVP (central venous pressure) catheter, as she subsequently charted by mistake. In that regard, she wrote in her nurse's notes, she says, merely what Dr. Eye had written in his order as to the description of the catheter to be removed. Dr. Eye had indicated in his orders to "D/C central line", which meant to disconnect the central line catheter (here, the subclavian) and because of the tremendous confusion at the nurses' station at the time she wrote her notes, she put in the wrong procedure. The subclavian catheter in question here was installed by Dr. Nunn, Mrs. Thornton's surgeon, on November 19, 1982.. During the procedure he inserted a 20-gauge catheter into the patient through the left subclavian area. He did not install any other catheter of a similar size. Somewhat later, he received a call from Mrs. Thornton's physician, Dr. Garcia, regarding the fact that a portion of the catheter was still in the patient and as a result, he performed surgery to remove it. He found a part of the catheter outside the wall of the subclavian vein and the remainder still in the vein. The entire portion of the catheter that was left in the patient was removed and the patient recovered satisfactorily from the surgery. In this regard, the danger inherent in leaving a piece of a catheter like this one inside a patient is that the broken remains could cause blockage of either a coronary artery, or if in the vein, a venal blockage. A third possibility is that of infection though this is somewhat more remote. According to Dr. Nunn, there are various causes for a catheter to break. The catheter may be subjected to rough treatment. The catheter itself may be weak. The catheter could be cut by the person removing it when the suture holding it in place is cut, and, although quite unlikely, the catheter might be broken when it is passed through the needle used to insert it. In Dr. Nunn's experience going back to 1955, however, he has never seen an instance where part of a subclavian catheter was left in a patient by accident. Mrs. Grace E. Davis, Mrs. Thornton's daughter, recalls that on the day Mrs. Thornton was released from the hospital, Mrs. Davis had to wait for her in the waiting room while an additional procedure was accomplished prior to the discharge. As Mrs. Davis recalls, when they got home from the hospital, she asked her mother why they had had to wait and Mrs. Thornton said that it was for the purpose of removing the catheter in her heart through which she was getting nitroglycerin. According to Dr. Earl T. Cullins, who reviewed Mrs. Thornton's medical records, she was in the hospital from November 17 through December 6, 1982. The medical records for that period indicated that the only catheters, IV's, or CVP's in the patient on November 26 may have been an Abbott Intravenous in the right arm and a subclavian catheter on the left side. The records further reveal that Dr. Eye gave verbal orders to disconnect the centerline (catheter) on November 26 and the nurse's notes written by Mrs. Scott indicate that on November 26, a CVP (central venous pressure--centerline catheter) was discontinued by her. CVP insertions are generally made in the subclavian plane or through the jugular vein, with the subclavian insertion being preferred. The records are, according to Dr. Cullins, somewhat confusing. For example, he cannot tell from the records whether the subclavian catheter was -being used for medication or whether it was covered with a pressure dressing on November 26. In any event, the records do not indicate that the left subclavian catheter was removed. Instead, they show that a CVP line (centerline catheter) was removed. While he feels that they are one and the same, he cannot tell for certain whether or not they are. At no place do the records or nurse's notes refer to the two together or as one and the same. Dr. Cullins had much to say about the performance of many of the other professionals involved in this case. For example, he described Dr. Eye as a "spastic" personality and questions the order that Mrs. Scott received to "remove the line." Dr. Cullin feels that if there were two lines in place, it cannot be certainly determined from the notes as to which one she removed. He also contends that Dr. Nunn made a mistake when he inserted the subclavian catheter on November 19 by not taking an X-ray after insertion. Another difficulty with the records, according to Dr. Cullin, is in that they reflect the intravenous needle was inserted in the patient's right hand on November 18 and was thereafter moved from hand to hand until November 26 when all drugs, which required two IV's, were stopped. To Dr. Cullin this indicates that even though the records do not specifically show the second line (other than the fact that the intravenous needle is in the right hand) there had to be one from a medical standpoint. Dr. Cullin is convinced that since the incident took place late in the day, it would not be at all unusual for Mrs. Scott to have mischarted the removal of the intravenous needle from the hand as the CVP needle which is in the only entry relating to removal of any intravenous lines. Dr. Cullin also states that the medical records, which on November 25 reflect "IV site good", and the fact that on- November 25, the nurse's notes refer to a transfer of the patient from the intensive care unit with the CVP line intact, without any other intravenous lines being mentioned, does not mean that there were no other lines. In short, Dr. Cullin is stating that the records are so confused it is impossible to tell whether there was one, two, or more intravenous lines in Mrs. Thornton on November 26, and which one was removed by Mrs. Scott. Ms. Ann Halley, Director of Nursing at Methodist Hospital, became aware of the situation involving Mrs. Thornton when she received a phone call from Dr. Nunn, who had installed the catheter and who told her that when he saw Mrs. Thornton that morning for a follow-up check, about a week after her discharge from the hospital, an X-ray showed that a portion of the subclavian catheter he had installed was still in her chest. Mrs. Thornton was returned to the hospital that afternoon for removal of the remaining piece of catheter, at which time Ms. Halley called for the medical records. when she checked them over, she saw that Respondent was the one who allegedly had removed the catheter. She contacted Ms. Jan G. Headrick, the head nurse on the floor with Mrs. Scott on November 26. Ms. Halley and Ms. Headrick had a discussion with Respondent about the situation during which Respondent admitted she had removed the catheter. In fact, she stated that when she cut the suture, the catheter simply fell out. According to Ms. Halley, Respondent did not actually use the term "subclavian" in regard to the catheter in question. However, in her opinion, there was little indication that Respondent was confused as to which catheter was in issue. Mrs. Thornton's patient records, as they relate to the catheter issue, were reviewed by Dr. Eileen Austin, a consultant with many years experience in the field of nursing. Dr. Austin concluded that a subclavian catheter had been removed from Mrs. Thornton in part by a nurse and that the remaining portion left in at the time of initial removal was surgically removed. Her review of the records revealed that three catheters were inserted during the first period of Mrs. Thornton's hospitalization. These were: An intravenous line inserted in the Patient's right hand on November 18, 1982 initially, but which was restarted several times and moved from hand to hand until it was finally capped on November 22, 1982. A catheter of this nature is always less than one inch in length and is never anywhere near seven and a half inches in length. A sub-clavian catheter inserted on November 19, 1982 which is also inserted in a vein. The purpose of this one appeared, here, too for administering drugs. It is approximately twelve inches in length and was removed, according to the records, by Respon- dent on November 26, 1982. An arterial line installed on November 19, 1982 following inser- tion of the sub-clavian catheter described above. The purpose of this line was for the withdrawal of blood for blood gas determination. It is called an arterial catheter and the longest one Dr. Austin has ever seen is two and a half inches. On the basis of the above, it appears obvious that the only one of the three catheters inserted, according to the records, long enough to have been left in the patient, was the subclavian catheter. A subclavian catheter is inserted into the clavian vessel so that the tip of the catheter is near the heart. It is inserted just below the collarbone. The records here reflected no reference in the nurse's notes after Mrs. Scott indicated removal of the subclavian catheter except for two references to dry dressings over the entry area. According to Dr. Austin, the proper procedure for the removal of a catheter is for the nurse to clip the suture holding the catheter to the skin without cutting the catheter. Thereafter, the nurse withdraws the catheter very carefully and, upon complete withdrawal, compares the length of the portion withdrawn with that of the catheter inserted as described in the patient's records. If a piece is broken off inside the patient, the visual examination in this way will reveal that that taken out is shorter than that put in, thereby indicating that some was left in the patient. Here, according to Dr. Austin, the Respondent failed to exercise proper procedure in two areas: one, she failed to note the length of the catheter inserted so that a comparison with removal could be done and, two, she failed to inspect the tip of the catheter on removal. It should be smooth and round. Anything else indicates that the catheter was broken or cut and part was left therein. This must be immediately reported to the physician. In Dr. Austin's opinion, a nurse who would remove a catheter and fail to insure the entire item was removed, and thereafter fails to report that it was not all removed, is unprofessional and puts the patient in a life- threatening situation. Further, assuming that the Respondent's sole improper activity was in mischarting the actual catheter removed, as Respondent contends, this could constitute substandard performance itself. However, the right arterial catheter in Mrs. Thornton was removed on November 20, 1982 at approximately 2:45 a.m. by Randy G. Martin, the hospital supervisor for the 11 - 7 shift that evening. He removed this catheter because the nurse on duty at the time saw that it was bent and there was some concern that it might break or otherwise do harm. At the time of this operation, Mr. Martin noticed that Mrs. Thornton had a subclavian catheter in place. When the arterial catheter was removed, it was measured and examined to see that the edges were good and then saved for the physician to examine the next day. If this arterial catheter was removed on November 20, it could not have been there on November 26, as Respondent says. Dr. Eye gave certain orders to discontinue all intravenous medication on November 22, 1982. The doctor's orders are as follows: D/C central line Per. with other meds this way Warm heat to rt arm Penicillin 500 mg-p/o Q.I.D. Serum theophyllin 6 hours after dose (scratched out) Room air arterial blood gas Sunday am. D/C all IV medication Dr. Eye's orders O.K.'d w Dr. Garcia Respondent as was stated before, contends she did not remove the subclavian catheter but instead removed the arterial catheter in the right arm, thereafter inaccurately charting its removal as the CVP catheter. She said she did this because she merely quoted the doctor's order. Thorough consideration of the above evidence admitted both for and against the Respondent, considered in light of the inherent probabilities and improbabilities of the evidence, results in the inescapable conclusion that Respondent did in fact withdraw the subclavian catheter from Mrs. Thornton and, in doing so, failed to insure that the entire catheter was removed. As a result, a 5 to 6 centimeter long piece of the catheter was left in Mrs. Thornton's chest which was surgically removed several days later. It is neither alleged nor found that Mrs. Scott was responsible for the catheter breaking. However, the evidence is clear that when she removed the catheter she failed to take those steps necessary and dictated by proper nursing procedures to insure that the entire catheter was removed. An independent examination of Mrs. Thornton's medical records by Dr. Austin, who had no part whatever in the scenario as it was acted at the time in question, revealed that three catheters were inserted in Mrs. Thorton during the period of her initial hospitalization: the subclavian catheter in the left portion of her chest; the arterial catheter in the right arm; and the peripheral catheter in one or both hands from time to time. The arterial catheter was removed by Nurse Martin on November 20, 1982. The peripheral catheter was capped on November 22, 1982. As a result, the only catheter remaining in Mrs. Thornton on November 26, 1982 was the subclavian catheter. when that fact is considered, along with the fact that Mrs. Scott's initial notes, regardless of her current explanation for them, revealed that she removed the CVP catheter (here it should be noted that CVP catheter is, in this case, the same as subclavian catheter), the conclusion is inescapable that she is the individual who removed the subclavian catheter leaving a portion in the patient. There simply is no evidence aliunde Mrs. Scott's own statement that any other catheter remained in the patient on November 26, 1982. This is so notwithstanding the testimony of Mrs. Davis concerning what her deceased aged mother advised happened the day of her discharge. It is difficult to believe that hospital officials would remove a subclavian catheter from Mrs. Thornton on the morning she is released from the hospital and Mrs. Davis' testimony as to that issue is rejected.
Findings Of Fact Dr. Gans is a chiropractor licensed in Florida on the basis of examination. Dr. Gans prepared and filed an application for examination and licensure with the Florida State Board of Chiropractic Examiners. Dr. Gans answered the question on the application, "Do you have a chiropractic license in any state?" by stating: "Ohio - Mechanotherapy." The Ohio authorities recognized several professions whose functions would be included under the practice of chiropractic in Florida. Mechanotherapy generally would be limited to the practice of manipulation only. Dr. Gans was licensed in Ohio as a mechanotherapist. Dr. Gans answered the question on the application, "Have you ever been refused licensure in any state?" by stating, "No." Dr. Gans had applied for, taken, and failed the Ohio chiropractic examination whereupon he was not issued a license as a chiropractor by the State of Ohio. Dr. Gans was eligible to reapply to take the Ohio examination. At the time of his application to Florida, Dr. Gans had appealed the determination by the Ohio authorities that he had failed the Ohio examination.
Recommendation Based upon the foregoing findings of fact and conclusions of law, the Hearing Officer recommends that the Florida State Board of Chiropractic Examiners revoke the license of Ray E. Gans. DONE AND ORDERED this 2nd day of October, 1978 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: John R. Sutton, Esquire 250 Bird Road, Suite 310 Coral Gables, Florida 33146 Paul Lambert, Esquire 1311 Executive Center Drive Tallahassee, Florida 32301 C. A. Hartley, Director Florida State Board of Chiropractic Examiners Suite 202, Building B 6501 Arlington Expressway Jacksonville, Florida 32211
The Issue This is a proceeding under Section 408.7056, Florida Statutes (2002), in which the issue is whether the denial by Health Options, Inc. (the Petitioner), of a request that it cover additional lymphedema outpatient therapy after a mastectomy to treat C.B. (the Subscriber),1 is consistent or inconsistent with the rules and laws that regulate managed care entities.2
Findings Of Fact The following facts were stipulated to at hearing by the Petitioner and AHCA: Effective April 1, 2002, the Subscriber in question was enrolled as a participant in a group HMO plan issued by the Petitioner to the Subscriber’s employer for the benefit of its employees and their eligible dependents. This plan constitutes an “employee welfare benefit plan” pursuant to the Employee Retirement Income Security Act of 1974 (ERISA). As a result of breast cancer, the Subscriber had a partial mastectomy of her left breast. Subsequent to her surgery, she required decongestic therapy due to lymphedema. The Petitioner authorized and provided coverage for decongestic physical therapy benefits for the Subscriber for services rendered from a participating provider for the authorized period of August 9, 2001, through October 18, 2001. The Petitioner denied coverage for additional decongestic physical therapy beyond the authorized period of August 9, 2001, through October 18, 2001, on the grounds that the Subscriber’s benefit had been exhausted under the terms of the Member Handbook. The Member Handbook for the Subscriber's HMO, signed by Robert I. Lufrano, M.D., the president of the Petitioner’s company, establishes the description of the rights and obligations of the Subscriber and the Petitioner with respect to the coverage and/or benefits to be provided by the Petitioner. Pages 20-23 of the Member Handbook requires the preparation and review every 30 days of a treatment plan as recommended by the Subscriber’s primary care physician or authorized provider. Further, provisions of the Member Handbook document the Petitioner's obligation to comply with state and federal laws and regulations and states that the terms of the agreement shall be interpreted to comply with those laws. Joel Mattison, M.D., is board-certified in plastic and reconstructive surgery. He holds a license in Florida and in North Carolina to practice medicine and surgery. Dr. Mattison has a specialty in plastic surgery and tropical diseases. Dr. Mattison's testimony establishes that the most common treatment form for lymphedema is a method of massage known as decongestic therapy. Lymphedema is the type of problem that will reoccur and no current treatment permanently eliminates the problem. If treatment is not received, the patient will suffer swelling of the body part located near the problem area causing trauma and infection with fungi and bacteria. The decongestic therapy is outpatient post-surgical follow-up care in keeping with the prevailing medical standard. As established by Dr. Mattison's testimony, the massage, which is the prevailing medical standard of care for lymphedemas, could be needed in excess of 62 days. Included in the therapy is the education of the patient to perform self-massage. The instruction in self-massage, however, is only part of the therapy and the other massage should not be discontinued. The evidence does not establish that the Subscriber received any instruction in self-massage or her ability to perform this function. In addition, Dr. Mattison testified that lymphedemas as a result of reconstruction and as a result of mastectomy, are indistinguishable without other indication, such as scars or patient history. Dr. Mattison testified that lymphedema pumps are available to assist in treatment. While it is hoped that the patient will learn how to use the pump, patients cannot always be depended on to learn to use them. The evidence fails to establish that the patient was offered a lymphedema pump or that using the lymphedema pump constitutes the prevailing medical standard.
