Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as certain stipulations of fact, the following relevant facts are found: The respondent Ali Azima was born in Iran and graduated from the Medical College at Tehran University, where he received his M.D. degree in 1961. He is Board-certified as an obstetrician-gynecologist. His experience includes the delivery of approximately 5,000 to 6,000 babies, the performance of approximately 3,500 termination of pregnancy procedures and the provision of about 1,000 intrauterine contraceptive devices to patients. At all times relevant to the charges in these proceedings, respondent was licensed by the Board of Medical Examiners in the State of Florida. Prior to the instant charges, respondent has had no Administrative Complaints filed against him. On February 18, 1981, Christine Sellers (now Kuchar) was admitted to the emergency room of Ft. Myers Community Hospital with severe abdominal pain. On that occasion, she learned that she was pregnant. On February 19, 1981, she went to the Southwest Florida Women's Clinic in Ft. Myers, operated by the respondent, for the purpose of terminating her pregnancy. Upon her arrival at the Clinic, she was asked to pay the requested fee and to complete two forms, a form entitled "Consent for Abortion, Anesthesia and Other Medical Services" and a form entitled "Patient Registration Record." The only medical information requested on these forms, in addition to height, weight and eye and hair color, regarded allergies to foods or medication, medication currently being taken and past operations or serious illnesses. For the latter question, N. Sellers answered "rheumatic fever." Respondent spoke to her for a few moments prior to the procedure, and performed a quick pelvic examination. He then performed the procedure for termination of the pregnancy, gave her some medication and instructed her to come back the following week for a follow-up examination. Respondent did not send any tissue specimen obtained from the procedure to a pathologist for examination nor did he administer Rhogam to the patient subsequent to the procedure. According to Ms. Sellers, neither respondent nor his staff performed any blood work or determined her vital signs before or after the abortion procedure, nor did anyone inquire of her as to her blood type or Rh factor. She knew that her Rh factor was negative, but did not volunteer this information to respondent because she did not realize that a negative Rh factor was important for purposes of a termination of pregnancy procedure. Respondent's medical records for Ms. Sellers do not indicate that blood was drawn from her or that her Rh factor was determined or known. While the record does indicate that a physical examination was "normal," no further information is provided. Ms. Sellers did not desire to return to respondent for her follow-up appointment. Instead, she made an appointment with Dr. Randall Cowdin for the same day she was supposed to see the respondent, February 26, 1981. On that occasion, Ms. Sellers was given a complete physical examination and her blood type was drawn. Upon learning that she had not been administered Rhogam following her termination procedure by respondent, Dr. Cowdin gave her an injection of Mini-Rhogam on February 26, 1981. Approximately one week later, on March 5, 1981, Ms. Sellers returned to Dr. Cowdin's office with complaints of severe right lower quadrant abdominal pain, with some nausea and vomiting. Dr. Cowdin determined that she was bleeding internally due to a ruptured right ectopic pregnancy, and immediately admitted her to the hospital. Emergency surgery was performed, resulting in the removal of the patient's right Fallopian tube and ovary. Ectopic or tubal pregnancies are difficult to diagnose. However, had a specimen of the tissue extracted from Ms. Sellers as a result of the procedure performed by respondent been carefully examined, it would have revealed that the products of conception had not been obtained from the patient's uterus as a result of that procedure. This finding would have at least raised the suspicion of an ectopic pregnancy. It would be extremely rare for a woman to have both an ectopic and a normal pregnancy at the same time. The chances for such an event are one out of 30,000. When performing abortions, four other physicians in the Ft. Myers area routinely send a tissue specimen to a pathology laboratory for examination. The purposes for this are to detect abnormalities, to determine if the patient was indeed pregnant and to determine the existence of an ectopic pregnancy. It is the respondent's practice to examine the tissue himself, having had some residency training in pathology and feeling competent to perform such an examination. If he has any doubts, he then sends a tissue specimen to a pathologist for further examination. It is extremely important to do a blood screening on a patient undergoing a termination of pregnancy proceeding. A determination of the hemoglobin level is significant in order to assess the risk of a procedure performed in a non-hospital setting and to prepare for the possibility of anemia after the procedure. The Rh factor needs to be determined so that Rhogam may be administered to the Rh negative patient. This injection combats antibodies and prevents sensitization or isoimmunization problems in the event of future pregnancies or future transfusions where the patient could again come into contact with Rh positive blood cells. The performance of a procedure to terminate a pregnancy without a determination of the patient's hemoglobin level and Rh factor constitutes medical treatment which falls below an acceptable standard of care. The patient medical records for Holli Schmidt indicate that she first went to the Southwest Florida Women' a Clinic, Inc. on December 1, 1977, and Dr. Azima performed a termination of pregnancy procedure. Her "Patient Information Sheet" lists her blood type and Rh to be "A+." On her follow-up exam, an IUD was inserted. This device was removed in December of 1980. On February 23, 1981, Holli Schmidt again went to respondent's Clinic. She completed a "Consent for Abortion, Anesthesia and Other Medical Services" form, told respondent that her last menstrual period had been about six weeks ago and that she was experiencing breast tenderness and nausea. A pregnancy test was performed on her, and the results were negative. Respondent performed a physical exam, noting on her record "Normal," and a pelvic exam, noting "Normal, uterus is not enlarged." Respondent then inserted a Copper 7 IUD, and instructed Mrs. Schmidt to return in one week. Ms. Schmidt did return on March 5, 1981, still complaining of breast soreness and slight nausea. Respondent performed another physical exam, noting "Normal," and a pelvic examination, noting "String is not visible, uterus sounded and IUD is in situ." The medical records do not indicate that she was given another pregnancy test on March 5, but respondent testified that she was and that such was written in the "pregnancy test book," a document not offered for admission into evidence. The records dated February 23 and March 5, 1981, do not indicate that blood work was done or that vital signs were taken. Mrs. Schmidt was instructed to return on March 14, 1981, but did not do so. On April 27, 1981, Holli Schmidt went to the offices of Yankopolos, Waterman and Cowdin, each of whom specializes in obstetrics and gynecology. The record dictated by Dr. Yankopolus indicates that Mrs. Schmidt told him that respondent had examined her the week before. She also told Dr. Yankopolus that she was having trouble with her IUD and was not feeling quite right, having symptoms of pregnancy. Dr. Yankopolus examined her, did not see the IUD string and determined that she was approximately 12 weeks pregnant. Fetal heart tones, which can be detected at 9 1/2 to 10 weeks of pregnancy, were heard. Dr. Yankopolus did no tests to determine if the IUD was still present, but did explain to Ms. Schmidt the dangers of possible miscarriage and infection from the presence of the IUD during pregnancy. It was noted that Ms. Schmidt "will consider all of the alternatives." On May 1, 1981, Ms. Schmidt presented herself to Dr. Waterman "for termination of pregnancy with a Copper 7 in place." After an examination, Dr. Waterman estimated that she was then "12-14 weeks size," and Dr. Cowdin concurred. This meant that conception occurred 10-12 weeks prior to the May 1st examination. Dr. Waterman performed the termination of pregnancy procedure. While his medical records for May 1, 1981, do not specifically state that he removed the IUD during the termination procedure, Dr. Waterman recalls that he did. A later notation on her medical records indicates that on March 30, 1982, Ms. Schmidt stated "she specifically remembers my removing it." Prior to the insertion of an intrauterine contraceptive device, the most important factor to determine is that the patient is not pregnant. An IUD can be the source of infection, thus endangering the mother and the baby during pregnancy. The safest and most appropriate time to insert an IUD is during the woman's normal menstrual period. While there are exceptions to this method, especially when the physician knows and trusts the patient, it falls below an acceptable level of care for a physician to insert an IUD when the patient has not had a menstrual period for six weeks, has symptoms of pregnancy and has been engaging in unprotected intercourse. Colleen Lundy, a registered nurse, went to respondent's office on March 5, 1981, for the purpose of undergoing a termination of pregnancy procedure. She completed the consent form and "Patient Registration Record" and spoke briefly with the respondent regarding some questions she had as to the procedure. Prior to the beginning of the procedure, no vital signs were taken and no blood work was performed. Respondent's medical record for Ms. Lundy simply indicates that the physical examination was "Normal." After respondent inserted the speculum, he requested his assistant to bring him Betadine, an antiseptic. The assistant informed him they were out of Betadine, and respondent replied, "use alcohol." Thereafter, patient Lundy felt a severe burning and was feeling very uncomfortable with the whole procedure. She informed respondent that she was not going to have the procedure, respondent removed the speculum and left the room, she dressed, received a refund of her fee and left. The burning sensation abated quickly. The following day, patient Lundy received a termination of pregnancy procedure at another clinic. Respondent admits that he told his assistant that alcohol could be used, but denies using any alcohol on patient Lundy. He further states that he did not perform the blood work because he did not perform the abortion. Darlene Baker first underwent a termination of pregnancy procedure performed by respondent in January of 1981. At that time, she completed a "Patient Registration Form," which inquired as to her height, weight, eye and hair color, allergies, prior operations or illnesses and current medications. She returned for another procedure on December 23, 1982, which was performed by the respondent. She received no counseling prior to the performance of this procedure, but did sign a consent form and a form explaining the procedure and risks for abortion. No further written information was obtained from her. While patient Baker does not recall that a physical examination or blood work was performed prior to the performance of the termination procedure, respondent's medical records for this patient indicate that a physical and pelvic examination were performed, that a blood pressure reading was taken and that the patient's "Rh is positive." Respondent did not send a tissue sample of the products of conception to a pathologist for further examination. Other physicians specializing in obstetrics and gynecology in the Ft. Myers area make it a routine practice to counsel abortion patients prior to the performance of the procedure. During the counseling session, the risks of the procedure involved are examined and other options for the management of an unwanted pregnancy are explored. Sufficient time is afforded between the counseling session and the performance of the termination procedure for patient reflection. The physical examination performed by these physicians includes the taking of vital signs, blood pressure, blood tests and a check of the abdomen, heart and lungs. Subsequent to the procedure, the products of conception are sent to a pathology laboratory for examination and the results are made a part of the patient's medical records.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent be found guilty of violations of Section 453.331(1)(t), Florida Statutes, and that his license to practice medicine in Florida be suspended for a period of one (1) year. Respectfully submitted and entered this 24th day of July, 1984, in Tallahassee, Florida. DIANE D. TREMOR, 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 24th day of July, 1984. COPIES FURNISHED: J. Riley Davis, Esquire 225 S. Adams St. Tallahassee, Florida 32301 Stephen Marc Slepin, Esquire 1114 E. Park Ave. Tallahassee, Florida 32301 Ellis S.Rubin, Esquire 265 NE 26 Terrace Miami, Florida 33137 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 N. Monroe St. Tallahassee, Florida 32301 =================================================================
The Issue Whether, as alleged in the administrative complaints, disciplinary action should be taken against Respondent's license to practice as a physician, based on separate violations of the following statutes for each patient as indicated below: DOAH Case No. 97-0337 Patient Statute T. D. 458.331(1)(g), 458.331(1)(t) F. R.-1 458.331(1)(g), 458.331(1)(m), 458.331(1)(t) S. M. 458.331(1)(g), 458.331(1)(t) F. R.-2 458.331(1)(g), 458.331(1)(m), 458.331(1)(t) T. M. 458.331(1)(g), 458.331(1)(t), 766.411 L. F. 458.329, 458.331(1)(j), 458.331(1)(m), 458.331(1)(t), 458.331)1)(x) C. G. 458.331(1)(k), 458.331(12)(m), 458.331(1)(n), 458.331(1)(t) DOAH Case No. 97-0338 J. S. 458.331(1)(m), 458.331(1)(q), 458.331(1)(t).
Findings Of Fact Based on the evidence presented in this proceeding, the following facts were found: Respondent is, and has been at all times material hereto, a licensed physician, having been issued license number ME 0056554 by the State of Florida. The Respondent was licensed in Florida in 1989. Prior to his licensure in Florida, he underwent residency training in OB/GYN at the State University of New York in New York City and St. Agnes Hospital in Baltimore, Maryland. Following his residency the Respondent performed a two-year fellowship in perinatology at the State University of New York in Syracuse. Patient J. S. On December 10, 1992, Patient J. S., a 19 year-old female, presented to Respondent for evaluation and medical care concerning her pregnancy. The patient was transferred from Orlando Birthing Center where she had her entire prenatal care. Upon presentation, Patient J. S. was at 42 weeks gestation. After examination in Respondent's office, Respondent subsequently made arrangement for admittance to Princeton Hospital for induction and delivery the following day. On December 11, 1992, at approximately 6:45 a.m., Patient J. S. was admitted to Princeton Hospital. At approximately 11:30 a.m., Pitocin, a legend drug, was administered by the staff as directed by Respondent. Pitocin, a derivative of the pituitary gland, is a commonly used substance to stimulate the uterus to contract. However, it is not risk free and must be used carefully. If the muscle is over-stimulated causing too much contraction, there can be interference with the blood supply to the placenta or it can cause the uterus to rupture. The use of Pitocin must be carefully monitored. Variability and reactivity of the fetal tracing was within normal limits at that time. At approximately 5:30 p.m., on December 11, 1992, Patient J. S.'s membranes were artificially ruptured and an internal fetal scalp monitor was placed. At approximately 7:30 p.m., the nursing assessment revealed that J. S. was 2 centimeters (cm) dilated, 70 percent effaced, and at minus 2 station. At approximately 10:10 p.m., Patient J. S. experienced a deceleration in the heart rate. At approximately 10:35 p.m., the patient experienced two more decelerations indicative of fetal distress. This resulted in the nurse on duty turning off the Pitocin. A vaginal examination revealed that Patient J. S. was still 2cm dilated, 70 percent effaced with the baby at a minus 2 station though the Pitocin had been running continuously for approximately 11 hours. During this period the Respondent was not on the premises. At approximately 11:50 p.m., Pitocin was re-initiated, and variable and late decelerations were again noted. Respondent was notified at approximately 1:10 a.m. and no new orders were given. Patient J. S.'s Pitocin was subsequently increased. Following the increase of Pitocin, Patient J. S. suffered an episode of variable decelerations which lasted approximately three minutes. The fetal heart rate was noted to be 64 beats per minute. Respondent was notified and Patient J. S.'s Pitocin was subsequently discontinued. However, Patient J. S. continued to suffer episodes of severe variable and late decelerations. In the early morning hours of December 12, 1992, Patient J. S.'s uterine contractions increased followed by late decelerations. Pursuant to Respondent's orders, Pitocin was restarted at 9:30 a.m. At approximately 10:00 a.m., Respondent arrived at the hospital. By approximately 1:45 p.m., poor variability was noted. At approximately 2:00 p.m., Patient J. S.'s fetal heart rate became unstable and decelerations became more profound. Evaluation revealed that the fetal heart tracing showed a distress pattern with repeated episodes of bradycardia and moderate to severe variable deceleration while the station of the baby never proceeded beyond minus 1 station. Respondent subsequently increased Pitocin. Despite poor fetal tracing, Respondent indicated that he intended a vaginal delivery. Patient J. S. was given an epidural with a bolus at approximately 8:00 p.m. At approximately 9:13 p.m., following four hours of full dilation, Patient J. S. was transferred to Labor and Delivery for a trial forceps set-up. Respondent applied Tucker/McLean forceps to the fetal head. At this time, fetal heart rate tracing was noted to be 80-90 beats per minute. Respondent subsequently determined that the infant could not be delivered and a Cesarean section was performed approximately 40 minutes later. The delay in delivery was the result of the need to wait for the surgical assistant to arrive, who was on-call, and for the anesthesia to take effect before he could operate. The infant was delivered with visible forcep marks including a skin lesion. The infant appeared to be emaciated and also displayed behavior indicative of a seizure shortly after delivery. A subsequent CT Scan revealed a subdural hemorrhage. The infant was later diagnosed as suffering from right facial nerve paralysis. Respondent failed to practice medicine within the acceptable level of care in that Respondent failed to appropriately monitor Patient J. S.'s progress during labor. Respondent failed to pursue the appropriate plan of treatment for Patient J. S. Patient J. S.'s poor response to Respondent's initial attempts to initiate labor indicated that Respondent should have pursued an alternative plan of treatment. Respondent failed to practice medicine within the acceptable level of care by failing to proceed to the hospital to evaluate Patient J. S.'s condition following the episode of bradycardia on the evening of on or about December 11, 1992. Respondent failed to practice medicine within the acceptable level of care by allowing Patient J. S. to continue in labor prior to the delivery of the infant given that the infant continued to suffer from unstable and variable heart rates. Respondent failed to practice medicine within the acceptable level of care by delaying delivery approximately four hours following full dilation. Respondent failed to practice medicine within the acceptable level of care by failing to appropriately apply forceps in attempts to deliver the infant. Respondent failed to maintain medical records which justified his course of treatment for Patient J. S. Respondent failed to appropriately utilize Pitocin. The continued usage of Pitocin following initial attempts to induce labor was inappropriate given Patient J. S.'s failure to progress during labor. Patient T. D. On or about August 24, 1992, Patient T. D., an 18 year- old female, presented to Respondent complaining of vaginal and abdominal pain during the previous two days. Respondent conducted a pelvic examination. Respondent did not observe vaginal bleeding. Respondent ordered the performance of an obstetrics ultrasound which revealed a viable 15-week intrauterine pregnancy. Respondent did not perform further tests to determine if Patient T. D. was experiencing premature labor. Patient T. D. was sent home and directed to go to the hospital if bleeding began. Later that evening, Patient T. D. presented to Princeton Hospital at which time she aborted. On August 26, 1992, Patient T. D. returned to Respondent for evaluation. Respondent performed an ultrasound and prescribed Methergine for bleeding. Patient T. D. presented with indications of premature labor on August 24, 1992. Respondent did not appropriately evaluate Patient T. D. for premature labor. Respondent failed to appropriately diagnose Patient T. D.'s condition or failed to pursue the appropriate plan of treatment. Patient F. R.-1 On September 20, 1992, Patient F. R.-1, a 38 year-old female, was hospitalized for abdominal pain and vaginal bleeding following a positive pregnancy test conducted at the hospital emergency room. During the hospitalization, Patient F. R.-1's, levels of human chorionic gonadotropin (HCG) declined, and she underwent a pelvic ultrasound. The test indicated that the patient had a non-viable pregnancy. Following her release from the hospital, on or about September 23, 1992, Patient F. R.-1, presented to Respondent with abdominal pain and bleeding and a history of a tubal ligation and non-viable pregnancy. Respondent performed a pelvic examination and asked her to return if the symptoms persisted. On or about October 8, 1992, Patient F. R.-1 presented to Respondent with the same symptoms, at which time Respondent initiated Patient F. R.-1 on Provera and Estrace. On or about October 15, 1992, Patient F. R.-1 presented to Respondent with irregular bleeding and abdominal discomfort. Patient F. R.-1 was advised to return in two weeks for evaluation. On or about October 29, 1992, Patient F. R.-1 returned to Respondent with continued complaints of abdominal pain. Respondent performed a pelvic ultrasound on Patient F. R.-1 which revealed normal follicular cysts in the ovaries. While treating Patient F. R.-1, Respondent failed to evaluate her HCG levels. Declining levels of HCG indicate that Patient F. R.-1 suffered an early miscarriage. Respondent failed to appropriately assess Patient F. R.-1's condition, failed to diagnose a probable early miscarriage, and failed to accurately observe the contents of the uterine cavity. Respondent failed to attain a conclusive diagnosis of Patient F. R.-1's condition. Respondent inappropriately treated Patient F. R.-1 with Provera and Estrace (hormones). The prescribing of hormones following an abortion is below the standard of care. Respondent failed to maintain medical records which justified his plan of treatment for Patient F. R.-1. Patient S. M. On or about July 13, 1992, Patient S. M., a 31 year-old female, presented to Respondent with complaints of pain and cramps. Patient S. M. presented with a history of two Cesarean sections, a tubal ligation, and an appendectomy. Patient S. M. presented subsequent to the performance of a pelvic sonogram, which suggested a small fibroid in the uterus. The sonogram was performed by another physician. On or about July 13, 1992, Respondent performed a second sonogram, and diagnosed multi-cystic ovaries and heavy menses. Respondent noted that Patient S. M.'s pelvic examination was normal. In the course of the office visit, Respondent scheduled M. for an exploratory laparotomy. On or about August 5, 1992, Patient S. M. presented to Princeton Hospital for the performance of an exploratory laparotomy, a lysis of adhesions, and a bilateral wedge resection of the ovaries with repair of the ovaries by chromic suture. Respondent performed the procedure. Following the operation, pathology report revealed normal ovaries. On or about July 13, 1992, Respondent did not misdiagnose Patient S. M.'s condition or fail to appropriately assess her complaints. Respondent failed to appropriately perform the surgical procedure on or about August 5, 1992. The repair of the ovaries by chromic suture is inappropriate for 1992 surgical techniques and will ensure the formation of adhesions post-operatively. Patient F. R.-2 On or about July 3, 1992, Patient F. R.-2, a 37 year- old female, presented to Respondent for the performance of a gynecologic examination. Respondent performed a normal pelvic examination. Respondent's examination revealed heavy menses, and he diagnosed yeast vaginitis and pelvic pain. Patient F. R.-2 presented with a history of several operations on her kidneys and gallbladder, an appendectomy, and a tubal ligation. Approximately six weeks later, Patient F. R.-2 returned to Respondent for the performance of a pelvic sonogram which revealed a single cyst on one ovary, and several cysts on the other ovary. Respondent subsequently scheduled Patient F. R.-2 for the performance of a wedge resection of the ovaries. On or about September 23, 1992, Patient F. R.-2 presented to Princeton Hospital for the performance of a bilateral wedge resection of the ovaries with repair of the ovaries by chromic suture, and lysis of minimal pelvic adhesions. The post-operative pathology report revealed sections of normal ovaries. Respondent did not appropriately diagnose, assess, and treat Patient F. R.-2's condition. Respondent failed to appropriately perform the surgical procedure on or about September 23, 1992. The repair of ovaries by chromic suture is inappropriate for 1992 surgical techniques, and will ensure the formation of adhesions post-operatively. Respondent failed to maintain medical records which justify his course of treatment for Patient F. R.-2. Patient T. M. On or about July 20, 1992, Patient T. M. presented Respondent with a complaint of irregular bleeding and pain. Respondent performed a pelvic examination of the patient and noted that Patient T. M. was taking birth control pills. On or about July 28, 1992, Patient T. M. returned to Respondent with continued abdominal and pelvic pain. In addition to his examination, Respondent performed an office ultrasound. Respondent made a diagnosis of polycystic ovarian disease. He also treated Patient T. M. for a urinary tract infection. On or about July 29, 1992, Respondent performed a second sonogram and noted no change in the pelvic cysts. Following the performance of the second sonogram, Respondent scheduled Patient T. M. for a wedge resection of the ovaries. On or about July 31, 1992, Respondent admitted Patient M. to Princeton Hospital for the performance of a wedge resection of the ovaries. The post-operative pathology report indicated that the removed portion of the ovaries were normal. Respondent failed to appropriately diagnose, assess, and treat patient T. M.'s condition. Respondent failed to attain a conclusive diagnosis of Patient T. M.'s condition. On or about July 31, 1992, Respondent inappropriately performed a surgical procedure on Patient T. M., which was not indicated, given that her ovaries were normal and some other reason was the likely cause of her bleeding. Respondent failed to appropriately perform the surgical procedure on or about July 31, 1992. The surgical techniques utilized by Respondent were inappropriate in that Respondent should have used a non-reactive suture. Respondent failed to maintain medical records which justify his course of treatment for Patient T. M. Patient L. F. On or about Friday, May 7, 1993, Patient L. F. was hired to work for Respondent as an insurance clerk. On or about Monday, May 10, 1993, Patient L. F. Reported for work at Respondent's office. Patient L. F. was agitated and nervous and complained of stomach pain. Patient L. F. left the office for the day around noon. On or about May 11, 1993, Patient L. F.'s second day of employment, L. F. reported to work, but went home at the beginning of the day complaining of stomach problems. She later reported back to work at approximately 12:15 p.m. Patient L. F.'s testimony that after she returned to work, Respondent inquired into how Patient L. F. was feeling; that Respondent invited Patient L. F. into an examination room for the purpose of performing an examination; that during the examination, Respondent touched Patient L. F.'s vaginal area with an ungloved finger; that Respondent placed his finger or fingers on L. F.'s genitalia area and started rubbing that area; that Respondent placed his palm on L. F.'s breast, then rubbed the side of her face with his knuckles, and told her how pretty she was; and that there was no other female present during the examination is not credible. On May 11, 1993, Respondent was in his office seeing patients until approximately 12:30 p.m. Shortly thereafter, he left the office and traveled to Princeton Hospital to do rounds. Respondent arrived in a Patient Lightfritz's room at approximately 1:00 p.m., and then examined at least two other patients. He then returned to the office, arriving shortly after 2:00 p.m.; Respondent began seeing patients for the remainder of the afternoon. Patient L. F. remained on the job for the remainder of the afternoon and left for the day at approximately 5:30 p.m. She did not return to work the next day, or thereafter. Respondent did not perform a physical exam of L. F. and she was, therefore, not a patient of Respondent. Patient C. G. On or about May 12, 1993, Patient C. G., a 29 year-old female, presented to Respondent with complaints of a backache and vaginal discharge. Respondent conducted an examination of Patient C. G., including a pelvic sonogram. Following the examination, Respondent administered an injection of Depo-Provera to the patient. Respondent contemporaneously prepared medical records on Patient C. G. justifying the course of treatment.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that in regard to DOAH Case No. 97-0337, Respondent be found guilty on Counts One, Two, Three, Four, Five, Six, Seven, Eight, Nine, Ten, Eleven, Twelve, Thirteen, and, it is RECOMMENDED that Respondent be found not guilty on Counts Fourteen, Fifteen, Sixteen, Seventeen, Eighteen, Nineteen, Twenty, and Twenty-one; and, it is RECOMMENDED that, in regard to DOAH Case No. 97-0338, Respondent be found guilty on Counts One, Two, and Three; and, it is further RECOMMENDED that the Respondent shall have his license to practice as a physician suspended for a period of one year; pay a civil penalty of $10,000, plus the costs of this prosecution; and the suspension be followed by a two-year period of probation, under such reasonable terms and conditions as the Board may require, including continuing medical education and evaluation. DONE AND RECOMMENDED this 1st day of April, 1998, at Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 1st day of April, 1998. COPIES FURNISHED: Gabriel Mazzeo, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Richard A. Simon, Esquire Rissman, Weisberg, Barrett, Hurt, Donahue & McLain, P.A. 201 East Pine Street 15th Floor Orlando, Florida 32801 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700 Pete Peterson, General Counsel Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700 Dr. Marm Harris, Executive Director Department of Health Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Board of Medicine, was the state agency responsible for the licensing of physicians and the regulation of the medical profession in Florida. Respondent is licensed as a physician in Florida, holding license # ME 0038234. His specialty is orthopedics but he is not Board certified in that field. Respondent practices medicine, specializing in orthopedic surgery with emphasis on the spine, at the Gulf Coast Orthopedic clinic in Hudson, Florida. Among the procedures he has performed at times pertinent to the issues herein are percutaneous lumbar foraminotomy, also known as foraminectomy or foraminostomy, (PLF); percutaneous cervical discectomy, (PCD); and percutaneous cervical foraminotomy, (PCF). A PLF is an arthroscopic surgical procedure wherein instrumentation introduced through a succession of progressively larger cannulae via a posterolateral approach to the lumbar spine is utilized to remove spurs which have formed at the area of the neural foramen. A PCD involves a similar introduction of instrumentation via an anterolateral approach to the cervical spine to remove disc material from a cervical disc for the purpose of decompressing the nerve root at the corresponding level. A PCF involves a similar introduction of instrumentation via an anterolateral approach to the cervical spine to remove spurs which have formed at the area of the neural foramen at the corresponding level. The three procedures referred to above, the PLF, the PCD and the PCF, are not commonly used or widely performed in the field of orthopedic surgery in the United States. Petitioner contends they are experimental procedures. Petitioner contends that a procedure whose safety and efficacy have not been established is experimental. It asserts that physicians performing procedures whose efficacy and safety have not been established must specifically advise a prospective patient on whom such procedure is anticipated to be done of the experimental nature of the procedure as a part of obtaining informed consent prior to the procedure. However, the efficacy and safety of a procedure are not, by themselves determinative of experimentation. PCD's are a logical extension/evolution of techniques that are already in use. They are being done in various places throughout the world, including the United States, and insurance companies have, in the past, paid for both PLDs, conceded by the Board to be non-experimental, and PCDs. The instant procedures in issue, including PLFs, which are done by physicians around the world, and the PCFs are not radical departures from present concepts. Though innovative, they are the natural evolution of existing techniques and procedures. For example, chemonucleolysis, recognized by the medical profession as non-experimental, is a percutaneous procedure in which enzymes are injected into the intervertebral disc in order to dissolve it. There is little difference between this procedure, which has been used for approximately ten years and the PCD, save the injection of the enzyme. Another percutaneous procedure which is widely done is the use of the nucleotome, a reciprocating suction cutter consisting of a steel tube with a spinning blade. This is not considered by the medical profession to be an experimental procedure. To be sure, Dr. Abram, a Board certified orthopedic surgeon with extensive experience in treating spinal pathology, is the only expert witness who practices in Florida. He has, however, by his own admission, not done any percutaneous or arthroscopic procedures involving the back or neck. On the other hand, Respondent's experts, Dr. Gristina, also a Board certified orthopedic surgeon, but who is not licensed in Florida, has extensive experience in orthopedic surgery. He was formerly Associ ate Professor of orthopedic surgery and associate to the chairman of that department at New York University Hospital; he was chairman of the Department of Orthopedic Surgery at Bowman Gray Hospital at Wake Forest University; and at present he is President and Senior Scientist at the Medical Sciences Research Institute and practices orthopedic surgery in northern Virginia. For the year just prior to this hearing, he was associated with the Northern Virginia Spine Institute, and though he has not been lead surgeon in the near term, he has associated with the director of the institute in the performance of major spinal surgery. Under the circumstances, as a scientist his opinion as to what constitutes an experimental procedure and what is mere innovation is pertinent to the resolution of that issue. Dr. Sherk, testifying for the Respondent, is a Board certified orthopedic surgeon and professor of surgery and chief of the division of orthopedics and rehabilitation at the Medical College of Pennsylvania. He is familiar with and has performed percutaneous procedures on the spine, most specifically chemonucleolysis and laser discectomy, and is familiar with Dr. Bonati and the percutaneous procedures he performs from having heard Respondent's presentations at international conferences on orthopedics. As a practitioner and academician, his opinion regarding the experimental nature of the procedures in issue is pertinent. Dr. Hopkins, a Board certified orthopedic surgeon, came to percutaneous disc surgery through the microdiscectomy process and the percutaneous laser procedure which he still uses. He also has performed in the neighborhood of two hundred percutaneous disc surgeries, about half with the nucleotome and half with laser. He has done percutaneous foraminectomy procedures. Some time ago, while working for a laser company in Minneapolis, he became aware of Respondent's practice in percutaneous disc surgery. As a result, he came to GCOC on two occasions and observed Respondent perform the procedure on both lumbar and cervical discs. He has presented papers on percutaneous disc surgery at international conferences and gave a course on percutaneous procedures at the American Academy of Orthopedic Surgery in San Francisco approximately two years ago. Taken together, and with all due respect and credence being afforded the opinion of Dr. Abram, the evidence of the experimental nature of the PLF, the PCD and the PCF is not persuasive and it is found that the procedures, though new and innovative, are logical extensions of and new uses of established procedures and are not experimental. Respondent's records reflect that in each case in issue, written consent was obtained from the patient. The records also reflect that each patient was informed about the surgery, the pathology and the treatment to which the patient had agreed. An informed consent was also obtained by the anesthesiologist. Under the circumstances, it having been found that the percutaneous procedures are not experimental procedures, the informed consent obtained by the Respondent was adequate. Clearly, Dr. Bonati's clinic is very well organized. As explained by Respondent and various members of his staff, once Respondent recommends surgery, the patient is given printed brochures and materials which explain the proposed procedure. If the patient is unclear as to the nature of the procedure or has any questions about it, he or she is given the opportunity to voice his or her concerns either to Respondent or to a nurse, and no further action is taken unless all questions are answered to the satisfaction of the patient. Each patient is also given a video tape describing the procedure to be performed, and once the tape is viewed by the patient, further opportunity to ask questions is afforded. Respondent and a nurse meet with each patient so that he can explain to the patient what the proposed procedure consists of, how it is to be performed and the risk involved. The patient is also advised of alternative methods of treatment which include physical therapy. Each patient is advised that an open procedure is also an alternative to the percutaneous procedure. The patient is under only a local anesthetic during the percutaneous procedure and is aware of what is going on. The patient actually assists the surgeon by reporting feelings and sensations experienced. Respondent claims an anesthesiologist is present in the operating room during the surgery and talks with the patient throughout the procedure. There was no evidence introduced that any patient had ever complained after the procedure that what was done was not what had been explained beforehand. Generally, patients are referred to the in-house physical therapist after surgery, and there was no indication any patient had complained of that either. AS TO THE PATIENT M.A. In August, 1989, Patient M.A., a 21 year old female, presented to the Respondent complaining of neck and back pain. Respondent had the patient undergo an MRI on the area. On September 12, 1989 he informed her that the MRI studies revealed posterior disc bulge at C3/C4 through C6/C7 levels, with the largest bulging at C4/C5 through C5/C6 levels. Additional MRI studies were done of the patient which, on November 17, 1989, Respondent interpreted as showing a grade II bulging at the C5/C6 and C6/C7 levels. On or about December 5, 1989, Respondent performed a PCD on this patient for a grade II bulge at the C5/C6 level on the left. Further MRI studies performed on this patient on or about October 30, 1990, indicated there was no change in the bulge at the C5/CB level as a result of Respondent's surgery. As a result, the Board's expert concluded that the surgery performed on this patient by the Respondent was not needed because the MRI's failed to show a condition requiring surgery and Respondent incorrectly interpreted them to indicate they did. The evidence shows, however, that in her visits to Dr. Bonati, the patient complained of pain in an area associated with the 6th nerve root, and evidence of the emergency room visit she made refers to a diagnosis of possible 6th nerve root involvement. Respondent's medical records for this patient reflect that before he recommended surgery, he waited out a period of conservative non-surgical treatment which included physical therapy. He also had her undergo another MRI on November 17, 1989, before the surgery, which showed a bulge at C5/C6. Respondent believed this bulge could be creating all the symptoms being experienced by the patient. In light of this additional evidence, to which Petitioner fails to refer in its Proposed Findings of Fact, it cannot be reasonably be found that the evidence of record is clear and convincing that Respondent performed unnecessary surgery. AS TO THE PATIENT R.L. On or about May 1, 1990, R.L., a 36 year old male, was seen by Dr. Jeffrey S. Walker, a Board certified neurosurgeon for evaluation of neck and back injuries sustained in a then-recent motor vehicle accident. Dr. Walker had this patient undergo an MRI which was interpreted by a Board certified radiologist as showing no large disc herniations and only minimal posterior bulging of the C4/C5 disc associated with degenerative disc disease. As a result of this test and interpretation, Dr. Walker diagnosed the patient as having severe cervical and lumbar strain with no evidence of radiculopathy or myelopathy. Radiculopathy is disease of the spinal nerve root, and myelopathy is a disturbance or disease of the spinal cord. Dr. Walker concluded that this patient's condition did not require surgery and recommended a conservative, non- surgical treatment. Nonetheless, on June 25, 1990, this patient went to see Dr. Bonati complaining of persistent neck and back pain. On this visit, the patient showed Dr. Bonati the MRI taken for Dr. Walker on May 31, 1990. When Respondent reviewed this MRI he noted a bulging disc at C4/C5 and recommended the patient undergo a PCD at that level. Before any surgery was done, however, another MRI was done on June 26, 1990 which Respondent interpreted as showing a 1 mm posterior disc bulge at L4/L5 and a 2 mm bulge at L5/S1, and as a result, Respondent recommended a PLD also be done. On July 12, 1990, Dr. Bonati performed a PCD on this patient at C4/C5 left, and on July 31, 1990 he also performed a PCD at C4/C5 right. Thereafter, on August 21, 1990, Respondent performed a PLF at L5/S1 on this patient. While the Board claims this was done to decompress the S1 nerve root, both the Board and Dr. Bonati indicate it is impossible to decompress the S1 nerve root by a foramenectomy at that level. The Respondent claims the procedure was done to remove the pressure on the L5 nerve root, and this was deemed possible by the testimony of Dr. Sherk. This would seem to be a more accurate description of what was done. In any case, Dr. Bonati also performed a PLD at L5/S1 right that same day in order to relieve the pressure on the S1 nerve root. In short, taken together, the evidence indicates that the surgery on the left was to relive pain on the left side and that on the right to relieve pain on the right side. There is a discrepancy in Respondent's records relating to the above surgery wherein left side pain is indicated where right side pain was intended. A review of these records, however, reveals that the patient complained of pain on both sides from the very beginning and clearly traces the course of pain from the first visit through the surgeries. The Board contends that Respondent failed to correctly interpret the MRIs done on this patient. It asserts these MRI's, when coupled with the patient's complaints, fail to indicate a need for surgical intervention and that Respondent's subsequent surgery performed on the patient was, therefore, inappropriate. This conclusion was stated by the Board's expert, Dr. Abram, who cited Respondent's own publications to the effect that a PLD is not indicated until a disc bulge is 4 mm or greater. Apparently Respondent had taken the position that a disc bulge of 3 mm or less does not merit surgery. It would appear Respondent's published indications also call for a certain amount of non- operative treatment to be provided, as well. It must be recognized, however, that there can be no hard and fast exclusionary rule regarding bulge size when determining whether surgery should be done. In the instant case, the records show that the patient continued to report pain which increased and diminished in cycles. The size guidelines are but one indicator of the need for surgery and Respondent cannot be faulted for doing surgery on a bulge smaller than that noted in his guidelines when other factors are present which indicate surgery is appropriate. AS TO THE PATIENT E.M. On or about April 4, 1991, Respondent saw patient E.M., a 51 year old male, who complained of pain in the lower back, the hip, groin and sciatic areas. Respondent had the patient undergo MRI studies which he interpreted as showing bulging discs at L4/L5, L5/S1, C4/C5 and C5/C6 levels. As a result of these indications, Respondent recommended the patient undergo both PLD and PCD procedures. Thereafter, on May 9, 1991, Respondent performed a PLF on this patient at L4/L5 left and a PLD at L4/L5 left. On June 19, 1991, he performed a PLF at L3/L4 left. He then performed a a PCD on this patient at C4/C5 left on July 1, 1991, and on July 18, 1991, performed a PLD at L5/S1 left. Finally, on August 6, 1991, he also performed a PCD at C5/C6 right on patient E.M. The bulges at C4/C5 and C5/C6 were categorized by the Respondent as grade II bulges. Respondent has previously stated that grade II bulges are normal pathology for which surgical treatment is not indicated. He performed three PLD procedures on this patient on three separate occasions rather than performing them simultaneously, and he performed the two PCD procedures separately rather than performing them simultaneously. The Board claims that to do this was inappropriate and constituted exploitation of the patient for financial gain. Dr. Gristina, however, indicates an alternative way of looking at the situation. He suggests that Dr. Bonati was following a plan to relieve the patient's symptoms utilizing the least invasive procedure available. Gristina suggests that Bonati's plan was to take the relief step by step, doing only so much surgery as was anticipated by him to be necessary to relieve pain. That a procedure was needed in each of five separate locations is unfortunate but not clearly shown by the Petitioner's evidence to be unnecessary. Petitioner must present evidence to show clearly that Respondent's actions were inappropriate. Petitioner's expert opinion must be considered, however, in light of the expert testimony to the contrary. The Board also notes that whereas this patient's medical records indicate the first procedure to be performed on May 9, 1991 was the PLD at L5/S1, in reality the initial PLD was performed at the L4/L5 level and there is no indication in the record as to why this was done. It also contends that Respondent attributed this patient's continued pain in the right leg to the L3/L4 level, and the performance of a PLD at that level without further diagnostic studies was a failure to practice medicine within standards. Dr. Abram also concluded that in light of the above, the Respondent's medical records for this patient, in failing to reflect the justification and appropriateness of his treatment of the patient, were inadequate. It would again appear that Petitioner has not given a complete reading to Respondent's medical records for this patient. His notes regarding the visits the patient made to the office reveal the patient was complaining of pain in the neck, shoulder and arms on both sides and indicate Respondent's concern that the patient might need surgery at L4/L5 as well as at L5/S1, and consent forms were obtained from the patient relating to both areas. An additional claim of Respondent's misconduct is made in regard to the Respondent's failure to do additional diagnostic studies before performing the PLD at L3/L4. However, Respondent contends that, contra to the importance placed on ancillary tests, he considers clinical examination of the patient and the patient's history as more significant. This position would appear to be supported by the testimony of Dr. Hopkins who opined that where, after a surgery has been done, if the patient is able to describe his or her condition, and nothing happened in the interim to cause the doctor to suspect any other problems, he would proceed without subjecting the patient to additional diagnostic procedures. All matters being considered, this would appear to be the more conservative approach. AS TO THE PATIENT P.H. Respondent first saw Patient P.H. in January, 1989 at which time he ordered an MRI be done which was interpreted as showing disc degeneration at L5/S1. When this was considered along with the patient's history, going back to 1970, of two disc removals, three spinal fusions and a laminectomy without relief, Respondent concluded a less conservative approach was demanded. Thereafter, on January 30, 1989, Respondent performed both a PLD and a PLF on this patient at L3/L4. No evidence was presented to clarify the apparent level discrepancy. The medical records indicate that after this surgery, Respondent prescribed Keflex, an antibiotic, and Colchicine, a gout treatment, for the patient. According to Dr. Abram, neither medication is justified in the medical records. The use of an antibiotic after surgery is not at all unusual nor inappropriate, however, especially in light of the fact that the surgery was done on an outpatient basis and the patient did not remain in the hospital, under observation, for a period of recuperation after the procedure. As to the Colchicine, a careful examination of the records pertaining to this patient reveals that a prior administration of the substance was indicated, and even Dr. Abram admitted that this drug could properly be used to treat back pain. The use of neither substance, therefore, was inappropriate. One year later, the patient again came to Respondent complaining of foot paralysis, and on February 1, 1990, Respondent performed a PLD on the patient at L4/L5. Twenty days later, on February 20, 1990, Respondent performed a repeat PLD on the patient at L4/L5. In the interim between the February 1 and February 20 procedures, notwithstanding Petitioner's contention that Respondent did not perform any diagnostic studies to determine whether further surgical intervention was necessary, the records indicate Respondent had clinical testing of the patient done on February 7, 1990, and a Physical Assessment Test was conducted which showed several anomalies which Respondent correlated to the MRI findings. Petitioner also claims that surgery at the L4/L5 disc space cannot treat the L5 nerve root compression that Respondent's tests showed in this patient. Both Dr. Bonati and Dr. Gristina agree, however, that the surgeon can reach the L5 nerve root from the L4/L5 disc space. This opinion by Dr. Gristina would apply equally as well to arthroscopic surgery as practiced by Respondent as to the more classical and conservative open procedures more widely done. Respondent billed the patient for all three surgeries performed. Evidence introduced at hearing, in the form of the opinion testimony of Dr. Abram, would seem to indicate surgery was not appropriate for this condition, and that the performing of the three surgeries was exploitation of the patient for financial gain. He also is of the opinion that the medical records fail to justify the course of treatment the Respondent rendered this patient. However, the evidence of record tends to indicate that a second surgery at a place where surgery has already been done is not unusual. Symptoms can recur and problems, thought to be resolved, can again surface. The evidence indicates that this patient had very little relief from discomfort and, in fact, the symptoms persisted for three weeks after the initial surgery. When results obtained from surgery do not produce an expected change in the patient's symptomology, Dr. Gristina concludes it is logical to again operate at any time after a procedure has been done. AS TO THE PATIENT M.M. Respondent first saw patient M.M. in July 1990 for symptoms of a back injury which he attributed to the S/1 nerve root and which had been present for over one year. The patient history for this patient reveals that she had approximately fifteen months without relief from pain before seeing Respondent and indicate that after Respondent had treated her for a week to ten days, the symptoms changed which caused Respondent to then attribute the cause to the L5 nerve root. An MRI showed a 4 mm bulge at L4/L5, and on September 6, 1990, Respondent performed both a PLD and a PLF at L4/L5. More than six months later, on May 7, 1991, M.M. went to Dr. Zubillaga, a Board certified neurologist, for treatment of pain running from the head to the sacrum. Dr. Zubillage took a complete patient history and reviewed the MRIs which had been taken by or for the Respondent. His examination indicated to him that no surgical intervention was indicated, and he recommended a more conservative treatment including stretching exercises and physical therapy. Dr. Abram concluded that Respondent's medical records for this patient contain inconsistencies in the examination and diagnostic tests. The patient's symptoms and the findings of diagnostic imaging should match up before the patient is offered surgical treatment. In the instant case, the records indicate a strength deficit of 26 percent at S1 and an L5 deficit of 16 percent, yet the treatment is directed against the L5 nerve root, even though the initial impression is that it was the S1 nerve root that was compressed, and Dr. Abram is of the opinion that is below the acceptable standard of care. Unexplained, it well may be. AS TO THE PATIENT D.R. On or about July 18, 1990, Dr. Bonati performed both a PLD and a PLF at L5/S1 on this patient for back and leg pain but the patient failed to improve after the surgery. Thereafter, on October 24, 1990, Respondent performed both a PLD and a PLF on the patient at L4/L5. Still later, on March 13, 1991, the patient saw Dr. Thomas Freeman, a Board certified neurological surgeon, who reviewed the patient's medical records, the discogram and the two MRI scans which had been done by Respondent both before and after the July 18, 1990 surgery, none of which showed an extruded disc. By the same token, a previous MRI done by a prior treating physician, Dr. Feldman, failed to disclose it as well. According to Dr. Freeman, the two MRI's done by Respondent were essentially identical with no change in the patient's condition following the surgery. Based on his examination of the patient, Dr. Freeman diagnosed the patient as having a large extruded disc at L5/S1 which, he claims, was shown in the MRI's taken by the Respondent. The evidence is in conflict on that point, however. It is Dr. Freeman's professional opinion that extruded discs are normally very difficult to remove by a percutaneous procedure. In fact, Respondent's own publications indicate that a percutaneous procedure is contraindicated in the case of an extruded disc. As a result of his evaluation, Dr. Freeman subsequently performed open back surgery on this patient removing the discs at L4/L5 left and at L5/S1 left and right. It is Dr. Abram's position that Respondent's failure to do an open procedure instead of a percutaneous procedure in this case, especially after the first procedure was unsuccessful, was below acceptable standard. It would appear, however, that none of the physicians who saw this patient were able to make a positive determination that there was an extruded disc. There is a difference between an extruded disc which is still in contact with the annulus and one which has broken free from the annulus and extruded through the posterior longitudinal ligament to enter the spinal canal. It is this latter situation which Respondent's writings denote as contraindication to a percutaneous procedure. The disc had not extruded in the instant case and, therefore, a percutaneous procedure was not necessarily contraindicated. Dr. Abram also asserts that Respondent's medical records for this patient contain a discrepancy between the admissions form and the general rule regarding the gravity and location of the patient's pain, which, he claims, is considered below standard. In fact, the admission form is set up so that the patient can describe the current severity of the leg pain and the back pain independently of each other. It does not attempt to compare them. AS TO THE PATIENT L.Q. Sometime between January and April, 1990, the patient, L.Q. saw Respondent complaining of pain in the neck and arm. Respondent took an MRI of the patient which indicated a grade I impression of the thecal space at both the C4/C5 and the C5/C6 levels. Even though Respondent's own publications regarding the PCD suggest that a grade I impression does not require surgery, Respondent recommended the patient undergo a PCD at C4/C5. Before agreeing to the surgery, however, on April 30, 1990, prior to what was described as the onset of significant pain compromising the 5th nerve root, the patient went to see Dr. Michael Slomka, a Board certified orthopedic surgeon who, without an MRI or CT scan, upon examination, found a normal neurological evaluation and a normal cervical spine x-ray. Based on his findings Dr. Slomka saw no basis for surgery and recommended a program of activity and rehabilitation for the patient. Thereafter, however, the patient returned to Respondent on May 14, 1990 and Respondent did a PCD at C4/C5. While Petitioner claims there was no justification shown for the surgery completed in this case, there is evidence in the patient records that the patient underwent an extended period of constant pain in the shoulder, injections into the shoulder by another physician prior to the visit to Respondent, continued medication for the discomfort claimed, and other symptoms and discomfort in an area consistent with the diagnosis, which were supported by a physical assessment test and consistent with the MRI. These factors may well justify surgery when all else has failed. The Petitioner asserts that Respondent's medical records do not reflect justification for the surgical intervention, but the above information disputes that conclusion. AS TO THE PATIENT R.H. This patient was seen by Respondent several times between July, 1991 and April, 1992 for treatment for neck and shoulder pain. An MRI of the patient ordered by the Respondent was interpreted by him as showing a grade I impression at both C3/C4 and C4/C5, and a grade II impression at C5/C6. On December 4, 1991. Respondent did a PCD on this patient at C5/C6, but the medical records maintained by Respondent on the patient show no improvement following the surgery. The Respondent's medical records relating to this surgery do not reflect he had any discussion with the patient before surgery about the risks or benefits of surgery, the anticipated outcome or alternative treatment options. On May 30, 1992, the patient went to see Dr. Michael Piazza, a Board certified orthopedic surgeon who also took an MRI of the patient. This scan revealed very mild degenerative disc disease at C5/C6 without any evidence of disc herniation or other operable lesion. He could see no indication for or reason to do surgery on the patient. The patient was 54 years old when she was seen by Dr. Piazza. The doctor indicated that approximately 90 percent of the adult population have as much arthritis in the neck by that age as does this patient. Therefore, he recommended non-operative treatment, including therapy, and the patient's condition improved markedly with this regimen. Here again the Respondent contends that Petitioner draws a misleading conclusion from the evidence and attempts to minimize the severity of the patient's long-term complaints of pain, failed conservative treatment and disc bulge which is attributed to arthritis. Respondent also contends that the use of a minimally invasive percutaneous procedure was appropriate in light of the circumstances, especially in light of the fact that there was a four month hiatus between the cited entries in the medical records. These contentions by Respondent are supported by the testimony of his experts. Respondent's records regarding this patient, are less than appropriate, however. They reflect the patient had full range of shoulder motion, albeit with pain, but also contain a diagnosis of frozen shoulder and capsulitis. This would indicate a marked reduction in the patient's range of shoulder motion. The records also indicate a degenerative labral tear in the biceps tendon, but there was no such tear indicated on the MRI. This tear was, however, located by Respondent through a diagnostic arthroscopy. In Dr. Abram's opinion, these inconsistencies rendered the records below acceptable standard. AS TO THE PATIENT O.J.P. This patient was seen at the Respondent's clinic, by Dr. Merken, on April 14, 1992, for an evaluation of the patient's strength related to the neck. The doctor's opinion was that the patient's neck strength was normal though, even as Dr. Abram admits, he found abnormalities of the neck resulting in painful flexion, lateralization and extension. Several days later, the patient underwent several MRIs which covered the left shoulder and the cervical and lumbar spine in which Respondent saw bulges of 2 mm, 3 mm, and 4 mm in the lumbar spine. When, on May 12, 1992, the Respondent discussed the results of the MRI's with the patient he noted a significant weakness in the patient which had not been noted by Dr. Merken earlier. Even though the patient's medical record does not reflect any long-standing weakness or participation in an extensive rehabilitative program, Respondent nonetheless recommended the patient undergo a PCD at C6/C7 left and a PLD at L4/L5 left. The surgery was not done, however. Instead, on July 16, 1992, the patient went to see Dr. Glen Barden, a Board certified orthopedic surgeon, because of persisting neck and back pain. Dr. Barden did an examination of the patient and reviewed Respondent's medical records on her. Dr. Barden's diagnosis was that the patient exhibited mild symptoms of disc disease without neurological deficits. He concluded that surgery was not needed or appropriate for the condition at that time but recognized that surgical intervention to the neck might be required. In fact, Dr. Barden's records show he found " cervical intervertebral disc disease, moderately severe, involving C4-5, C5-6. C6-7 and C7-T1, as well as degenerative lumbar disc disease", among other problems, all of which, Dr. Barden admits, can cause pain and restriction of motion without a neurological deficit. As such, surgery can be justified even where there is no neurological deficit. Notwithstanding Petitioner claims the medical records kept by Respondent on this patient did not reflect any long-standing weakness or conservative care, the patient history clearly reflects numerous complaints of pain and limitations on movement following a 1978 car accident. In addition, the records reflect the patient had been taking medication and received chiropractic treatment in addition to the physical therapy prescribed by Respondent prior to surgery.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that the Administrative Complaints in DOAH Cases 94-1866 and 94-1867, except for Counts Six and Fifteen of Complaint 94-1867, of which Respondent, ALFRED O. BONATI, should be found guilty, be dismissed, and that his license be reprimanded. RECOMMENDED this 21st day of August, 1995, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of August, 1995. APPENDIX TO RECOMMENDED ORDER IN CASES NOS. 94-1866 AND 94-1867 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: & 2. Accepted and incorporated herein. 3. - 7. Accepted and incorporated herein with the addition, as to #7, of the phrase, "in the U.S." 9. - 8. Accepted and incorporated herein. 11. Accepted and incorporated herein. 12. & 13. Accepted and incorporated herein. 14. & 15. Accepted. 16. & 17. Accepted. 18. - 21. Accepted. 22. - 24. Accepted and incorporated herein. 25. Accepted. 26. Rejected as not proven. 27. - 29. Accepted. 30. - 35. Accepted and incorporated herein. 36. - 38. Rejected as not proven by clear and convincing evidence. 39. Rejected except for last sentence which is accepted. 40. Accepted. 41. & 42. Rejected as not proven. 43. - 53. Accepted and incorporated herein. 54. Accepted that surgery was done, but not for the purpose stated. 55. Accepted and incorporated herein. 56. Accepted and incorporated herein. 57. - 62. Rejected as not proven. 63. Rejected as not proven. 64. Accepted as to what record states, but rejected as to the lack of a complaint on the right side, as contra to the weight of the evidence. 65. Rejected as not proven. 66. - 68. Accepted but considered of little probative value. 69. Accepted. 70. & 71. Rejected as not proven. 72. & 73. Accepted and incorporated herein. 74. & 75. Accepted and incorporated herein. 76. - 80. Accepted and incorporated herein. 81. - 84. Rejected as not proven. 85. Accepted. 86. - 92. Rejected as not proven. 93. Accepted. 94. - 97. Rejected as not proven, and 97 is duplicative of 84 and 84. 98. - 104. Accepted and incorporated herein. 105. - 109. Rejected as not proven. 110. Accepted and incorporated herein. 111. Rejected as unproven. 112. & 113. Accepted and incorporated herein. 114. Rejected as unproven. 115. - 117. Accepted. 118. & 119. Rejected as unproven. 120. Accepted. 121. Rejected as unproven. 122. - 128. Accepted and incorporated herein. 129. - 132. Rejected as unproven. 133. Accepted. 134. & 135. Rejected as unproven. 136. - 148. Accepted and incorporated herein. 149. - 152. Rejected as unproven. 153. - 159. Accepted, but 158 is duplicative of 146 160. & 161. Rejected as unproven. 162. - 168. Accepted and incorporated herein. 169. Rejected as unproven. 170. Accepted and incorporated herein. 171. - 175. Rejected as unproven. 176. Accepted. 177. & 178. Rejected as unproven. 179. - 191. Accepted and incorporated herein. 192. - 194. Rejected as unproven. 195. Accepted. 196. & 197. Rejected as unproven. 198. - 208. Accepted and incorporated herein. 209. - 211. Rejected as unproven. 212. Accepted. 213. Rejected as unproven. FOR THE RESPONDENT: 1. - 3. Accepted and incorporated herein. 4. & 5. Accepted and incorporated herein. & 7. Accepted and incorporated herein. Accepted and incorporated herein. & 10. Accepted. 11. & 12. Accepted. - 15. Accepted. 16. - 18. Accepted and incorporated herein. 19. & 20. Accepted. 21. - 23. Accepted and incorporated herein. 24. Accepted. 25. First sentence accepted. Second sentence not proven. 26. & 27. Accepted. 28. Accepted and incorporated herein. 29. Accepted. 30. - 32. Accepted. 33. Accepted. 34. & 35. Accepted since the contrary was not proven. 36. Accepted as represented. 37. Accepted since the contrary was not proven. 38. Accepted that the treatment and records were within standards. COPIES FURNISHED: Britt Thomas, Esquire Natalie Duguid, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jonathan W. Lubell, Esquire 750 Lexington Avenue New York, New York 10022 Salvatore A. Carpino, Esquire 8001 North Dale Mabry Highway Suite 301-A Tampa, Florida 33614 Jerome W. Hoffman General Counsel Agency for health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact At all times material hereto, Respondent has been licensed as an osteopathic physician in the State of Florida, having been issued license number OS-0001053 in 1954. According to Respondent's office records for a patient named Barry Belikoff, Respondent saw Belikoff in his office on twenty-five (25) occasions between September 5, 1980, and July 24, 1981, and during this time wrote twenty-four (24) prescriptions for a total of 344 Quaaludes (Methaqualone) with a dosage of 300 mg. each. According to his patient records, Respondent also saw Belikoff on thirteen (13) occasions between October 31, 1981 and June 18, 1982 and wrote four (4) prescriptions for controlled substances, including Talwin, Restoril, and Percodan. Respondent was treating Belikoff for back pains and insomnia. According to expert testimony, the records kept by Respondent of this patient's office visits were inadequate and do not provide the required documentation which would support and explain the controlled substances prescribed in this case. In addition, a proper course of patient care would not include the on-going prescription of Quaaludes over almost a one year period at a rate of over one a day without a record of additional tests, x-rays, or neurological exams during this period. Belikoff's patient records do not show any such additional tests, x- rays or exams. Without such documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Belikoff were without medical justification, excessive and inappropriate, according to expert testimony. Respondent was treating a patient named Lyndon Ellis during 1981 and 1982. Ellis was hospitalized on four occasions while under Respondent's care, and according to expert testimony the level of care and medical records for this patient, while hospitalized, were excellent. As a result of office visits by Ellis, Respondent wrote thirty-eight (38) prescriptions for controlled substances between April 20, 1981 and September 29, 1982 which included Percocet 5, Demerol, and Fiorinal. Ellis was being treated by Respondent for chronic headaches and pain from accident injuries, and also for a problem with his toe. However, according to expert testimony, the records kept by Respondent on Ellis' office visits were inadequate and do not provide documentation which would support and explain the controlled substances prescribed in this case. The absence of a thorough patient medical history, exam, evaluation, x- rays and lab tests in this patient's office records is explained by Respondent by the fact that this information was available in hospital records for this patient. Nevertheless, Respondent's office records for Ellis are totally inadequate. These office records do reflect that Respondent was aware of Ellis' overuse of controlled substances and the need to detoxify this patient on October 29, 1982. Yet he prescribed Percocet, a controlled substance, on five additional occasions after October 29, 1982. Without adequate documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Ellis were without medical justification, excessive and inappropriate, according to expert testimony. Between July 14, 1980 and April 23, 1982, Respondent treated a patient named Alan Fogler. During this time Respondent wrote twelve (12) prescriptions for a total of 464 Percodan, a controlled substance. Respondent was treating Fogler for headaches, whiplash and a concussion reported by the patient, as well as allergies, but patient records reveal no x- rays, brain scans, lab work or neurological exams. According to expert testimony, patient records in this case are inadequate and do not justify the treatment rendered which consisted primarily of prescriptions for Percodan. Without adequate patient medical records, the prescriptions for controlled substances were without- medical justification, excessive and inappropriate, accordingly to expert testimony. While treating patients Belikoff, Ellis and Fogler, Respondent repeatedly reissued prescriptions for controlled substances without a substantiation of medical reasons in the patients' office medical records. According to expert testimony concerning the standards expected of osteopathic physicians in keeping office medical records on patients, Respondent did not perform with reasonable skill, nor meet the standards expected of physicians in this aspect of their practice. Vicki Cutcliffe, a deputy sheriff with the Broward County Sheriff's Office, saw Respondent in his office on March 30, April 11 and April 25, 1984 using the alias "Vicki Tarra". After taking a brief medical history which revealed that "Tarra" used alcohol daily, Respondent began treating her for situational anxiety by prescribing controlled substances, including Librium and Tranxene. On April 25 "Tarra" told Respondent she wanted some extra pills for her friend named Jo Ann and asked him to write her friend a prescription. Respondent said he could not do that, but did give "Tarra" a prescription for Tranxene and two refills, after initially giving her a prescription which allowed for only one refill. He told her that she could give some of the pills to her friend and then she could refill the prescription twice. Respondent knew that "Tarra" wanted the extra pills for a friend and that she would give them to her friend who was not a patient of Respondent. According to expert testimony, the treatment given to "Tarra" by Respondent, which consisted simply of prescriptions for controlled substances without adequate documentation of the reasons for this course of treatment in the patient's medical records, was totally inappropriate. Increasing a prescription when a patient says they want some extra pills for a friend is never justified and constitutes malpractice, according to expert testimony.
Recommendation Based upon the foregoing it is recommended that a Final Order be issued suspending Respondent's license for a period of two ( 2) years. DONE and ENTERED this 30th day of September, 1985, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 3 2301 (904) 488- 9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 1985. COPIES FURNISHED: Stephanie A. Daniel, Esq. Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 John W. Gaul, D.O. 11360 Tara Drive Plantation, FL 33325 Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners 130 North Monroe Street Tallahassee, FL 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 ================================================================ =
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against a licensed medical doctor. By means of a two-count Administrative Complaint, the Respondent is charged with violations of Sections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, by allegedly failing to keep written medical records justifying the course of treatment of a patient, and by failing to practice medicine with the required level of care, skill, and treatment. The Respondent denies the violations charged in the Administrative Complaint, and also asserts that the Administrative Complaint should be dismissed by reason of the Petitioner's failure to timely investigate and prosecute the subject charges.
Findings Of Fact Findings stipulated by the parties4 The Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida. The patient R. C. presented with a history of diabetes and hypertension. The Respondent did not attempt or make any contact with the primary care physician of patient R. C. Brevital was administered intravenously to the patient R. C. without the use of an IV pump. Resuscitative drugs and equipment should always be immediately available. There is no documentation of respiratory monitoring during the administration of anesthetics and the surgical procedure performed on patient R. C. It is well below the standard of care to both administer a general anesthesia and perform the surgical procedure. Findings based on evidence At all times material, the Respondent has specialized in urology. The Respondent is not board certified in urology. At all times material to this case, the Respondent was associated with a clinic named Instituto Latino Americano de Impotencia y Diagnostico (ILAID). One or two days each week, the Respondent would see patients at ILAID that were potential candidates for penile implant surgery. At all times material to this case there were at least two other licensed physicians associated with ILAID who often were the first physicians to see patients who came to ILAID with complaints of impotency. The subject patient (Patient R. C.) went to ILAID for the first time on May 24, 1993. On that day the patient signed a form titled "Patient Information," which contains little more than patient identification information, and a form titled "Patient's Declaration and Agreement."5 The patient probably saw a physician at ILAID on May 24, 1993, because a blood sample was taken from the patient that day and the results of the blood tests were reported back to ILAID on May 25, 1993. However, there is no documentation that the patient was seen by a physician at ILAID on May 24, 1993. Specifically, there is no medical chart documenting that on that day a physician took a history from the patient, examined the patient, evaluated the patient, ordered any tests of the patient, or otherwise treated or cared for the patient. At all times material to this case, the routine practice and procedure of ILAID regarding patients who went to ILAID with complaints of impotency was to have the patients seen by a physician associated with ILAID. It was also the routine practice and procedure at ILAID for the physician who first saw the patient to prepare a-medical record documenting the patient's visit. Such a medical record would routinely document a patient history, an examination of the patient, the physician's evaluation of the patient, and any treatments given or tests ordered by the physician. The impotency patients at ILAID were also routinely put through an evaluation procedure to determine the extent of and the nature of their impotency before implant surgery was recommended or performed. The results of the evaluation procedure were also routinely documented in the patient's medical chart. The Respondent first saw the subject patient on July 13, 1993, at the ILAID facility. On that date there were no patient records regarding the subject patient prepared by any other physician associated with ILAID for the Respondent to review. In the absence of any medical documentation, the Respondent apparently assumed that the patient had been through the normal routine at ILAID and proceeded to go forward on that assumption. On July 13, 1993, the Respondent took a brief, limited history from the patient and conducted a limited physical examination of the patient. The physical examination was limited to the patient's abdomen and urogenital area. Based on that limited history and examination, the Respondent concluded that penile implant surgery was an appropriate course of treatment, subject to the patient receiving medical clearance for the surgery. The Respondent did not perform any objective tests for impotence on the patient. The Respondent did not obtain a detailed medical history from the patient. The Respondent did not obtain a detailed history regarding the nature, extent, or duration of the patient's impotence. The Respondent did not conduct a complete physical examination of the patient. Prior to performing penile implant surgery, a physician should perform objective tests to determine if the surgery is indicated. Two objective tests that should always be performed are blood tests to determine the patient's testosterone level and prolactin level.6 Depending on the details elicited during the patient history, other objective tests may also be indicated. The Respondent failed to have tests done to determine the testosterone level and the prolactin level of the patient. The failure to perform these two objective tests is a departure from acceptable standards of medical care recognized by a reasonably prudent similar physician. Prior to performing penile implant surgery, a patient's condition must be assessed by a physician to determine whether surgery is indicated. The surgeon does not have to personally perform all aspects of the assessment of the patient's condition, but the surgeon must at least verify that an adequate assessment has been performed by another physician, and that the assessment has been documented in the patient's medical records. Adequate assessment of a patient's condition requires, at a minimum, a detailed medical history, a complete physical examination, and the performance of any objective tests indicated by the history and physical examination. The performance of surgery without either performing an adequate assessment of the patient's condition or verifying that such an assessment has been documented by another physician is a departure from acceptable standards of care recognized by a reasonably prudent similar physician. The Respondent did not obtain a detailed medical history from the patient, did not perform a complete physical examination of the patient, and failed to order at least two objective tests that were indicated by the patient's complaints. The Respondent also failed to verify that documentation existed which showed that any other physician had obtained a detailed medical history from the patient, had performed a complete physical examination of the patient, and had ordered the objective tests indicated by the patient's complaints. If the Respondent had attempted to verify the existence of such documentation, he would have discovered that the documentation did not exist. The Respondent's performance of surgery on the patient without performing an adequate assessment of the patient's condition, or without verifying that such an assessment had been documented by another physician, was a departure from acceptable standards of medical practice. The Respondent made arrangements for additional blood tests and for an EKG to be administered to the patient. The Respondent also believed that he had made arrangements for one of the other physicians at ILAID to medically clear the patient for surgery. Anticipating no problems regarding the medical clearance, the Respondent also contacted the director of ILAID, Rogelio Medel, and asked him to arrange a location for the implant surgery. In view of the patient's financial circumstances and his lack of medical insurance, it was decided that the surgery would be done in an operating room at a physician's clinic, which would be somewhat less expensive than performing the surgery in a hospital operating room. Rogelio Medel contacted Dr. Francisco A. Prado and arranged for the use of one of the operating rooms at Dr. Prado's clinic. Rogelio Medel had made similar arrangements with Dr. Prado twice before. The arrangement with Dr. Prado was that Dr. Prado would provide not only the use of the operating room, but would also provide all necessary supplies (including the anesthesia medications), as well as the services of a nurse anesthetist, Eduardo Perez, who worked for Dr. Prado on a regular basis. The surgery was scheduled for early in the afternoon on July 16, 1993. Unbeknownst to Rogelio Medel and to the Respondent, Eduardo Perez was not a licensed nurse anesthetist. The Respondent did not inquire of Eduardo Perez regarding the latter's qualifications or licensure status. Rather, relying on the representations of Dr. Prado, the Respondent assumed that Eduardo Perez possessed the necessary qualifications and licensure to function as a nurse anesthetist. While it is clear that Eduardo Perez was not licensed as a nurse anesthetist, there is no clear and convincing evidence in the record as to whether Eduardo Perez was or was not trained in the use of anesthetics, was or was not trained in the use of respiratory and cardiac monitoring equipment, or was or was not trained in the use of resuscitative drugs and equipment.7 The Respondent assumed that Eduardo Perez was trained in these matters, based on the assumption that Eduardo was a licensed nurse anesthetist. In view of the representations of Dr. Prado, it was reasonable for the Respondent to make that assumption.8 The Respondent was not trained in the techniques and procedures of advanced cardiac life support. The Respondent was not trained in the use of a defibrillator. The Respondent was not trained in the use of anesthetics. Prior to performing surgery on the subject patient, the Respondent had received a copy of the laboratory results dated July 16, 1993. He had also received a copy of the EKG report prepared by Dr. Freddie Rodriguez. Prior to performing the surgery, the Respondent had not received any written medical clearance for the patient to undergo the planned implant surgery. The Respondent never received any written medical clearance for the patient to undergo surgery, because the patient was never medically cleared. The Respondent did not receive any telephonic verification that the subject patient had been medically cleared for surgery, because no other physician had cleared the patient for surgery.9 Prior to performing surgery, it is the responsibility of the surgeon to verify that the patient has been medically cleared for the proposed surgery. Under similar conditions and circumstances, a reasonably prudent similar physician would not perform surgery without verification that the patient had been medically cleared for the proposed surgery. It is a departure from minimum standards of medical practice for a surgeon to perform surgery without such verification. Early in the afternoon on July 16, 1993, the Respondent performed penile implant surgery on the subject patient. The surgery was conducted in one of the operating rooms at Dr. Prado's clinic, as previously arranged with Dr. Prado. During the surgery the patient was anesthetized with the anesthetic agents Versed and Brevital. These anesthetic agents were administered by Eduardo Perez, who was functioning as a nurse anesthetist. Eduardo Perez was present during the entire surgical procedure, during which time he monitored the administration of the anesthetic agents, monitored the patient's vital signs, and otherwise performed the functions that would be performed by a nurse anesthetist. At all times material, the Respondent believed, based on the representations of Dr. Prado, that Eduardo Perez was a licensed and qualified nurse anesthetist who regularly worked in that capacity for Dr. Prado. When the surgical procedure had been completed, the Respondent left the patient in the care of Eduardo Perez while the Respondent left the operating room to change clothes. When the Respondent left the operating room the patient appeared to be normal. When the Respondent returned to the operating room a few minutes later, he noticed that the patient had become pale and sweaty. The Respondent also noticed that the patient had very little pulse or blood pressure. The Respondent and Eduardo Perez initiated cardiopulmonary resuscitation and also called fire rescue for assistance. The Respondent and Eduardo Perez continued their cardiopulmonary resuscitation efforts until the fire rescue personnel arrived a few minutes later. The fire rescue personnel initiated advanced cardiac life support measures and subsequently transported the patient to a hospital emergency room, where further efforts were made to resuscitate the patient. Shortly thereafter the patient was pronounced dead in the emergency room. Following an autopsy and investigation into the cause of death, the Dade County Medical Examiner was of the opinion that it could not be stated with any degree of medical certainty that the death of the subject patient was caused by the surgery. In order to have medical records sufficient to justify penile implant surgery, a physician must have written medical records that document at least the following matters: (a) a detailed patient history; (b) a complete physical examination of the patient; (c) a consideration of alternative therapy options; and (d) a pre-operative medical clearance. With regard to the subject patient, the Respondent does not have, and never did have, written medical records documenting any of the four matters itemized immediately above. By failing to keep written medical records documenting such matters with regard to the subject patient, the Respondent failed to keep records justifying the course of treatment of the patient.10
Recommendation On the basis of all of the foregoing it is RECOMMENDED that a Final Order be issued in this case concluding that the Respondent has violated Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, imposing a penalty consisting of the imposition of administrative fines totaling $6,000. 00, and the suspension of the Respondent's license to practice medicine for a period of 90 days. DONE AND ENTERED this 23rd Day of September, 1998, in Tallahassee, Leon County, Florid __________________________________ MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 1998.
