The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Carl Fromhagen, M.D., based on allegations that he violated Subsections 458.331(l)(k),(m) and (t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the following findings of facts are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1956 and issued License No. ME 0007027. Respondent is board-certified in Obstetrics and Gynecology (1967). He is 74 years old and now has an office- based practice treating only gynecological patients. Patient K. B., a 46-year-old female, first presented to Respondent on September 6, 1990, with menopausal complaints. Her patient's history reflects that she reported a family history of breast cancer. On February 12, 1992, Patient K. B. presented to Respondent with complaints of a mass in her left breast. Respondent palpated a mass in K. B.'s left breast and, although he did not note the size of the mass in his office records, the records contain a diagram showing the location of the mass. Petitioner testified that it was his practice that when he discovered a mass of less than 2.5 centimeters, he did not describe the size because its too hard to identify the exact dimensions smaller than an inch. Respondent ordered a mammogram for Patient K. B. which was performed on February 19, 1992, and was interpreted as revealing no evident neoplasm (cancer). Respondent saw Patient K. B. in his office on the following dates (after the mammogram): March 30, 1992; May 21, 1992; August 31, 1992; April 19, 1993; April 27, 1993; May 4, 1993; May 11, 1993; May 18, 1993; September 21, 1993; and November 16, 1993. In addition, Patient K. B. had telephone contact with Respondent's office staff to have prescriptions refilled and was mailed examination reminder notes. Patient K. B. testified that she and Dr. Fromhagen discussed the breast mass "every checkup, every time I was there." She inquired about a follow-up mammogram and Dr. Fromhagen indicated that she could wait two years. He did not mention a biopsy, excision, or referral to another physician at anytime. Patient K. B. and Respondent agree that Respondent examined and palpated the breast mass during her physical examinations which took place approximately every six months. During civil litigation that preceded the instant administrative hearing, it became apparent that there were two different sets of office records for Patient K. B. Patient K. B. testified that during the civil action she brought against Respondent in 1996, Respondent had produced medical records, purported to be hers that did not accurately reflect her treatment. She recalled that upon comparing the medical records Respondent had produced in the civil action with the records she had obtained from Respondent's office in December 1994, she discovered that Respondent had "augmented" her records, which she reported to her attorney. In May 1994, the offices of Dr. Paul Straub, who became Patient K. B.'s new treating physician as a result of a change in her group health insurance, requested her medical records from Dr. Fromhagen's office. Dr. Fromhagen testified in the instant hearing that "at the time . . . I compared the chart [Patient K. B.'s records] with . . . 'day sheets' and because I felt the records did not reveal everything that Dr. Straub should be aware of, I rewrote certain portions of them to reflect things that were on the day sheets that I hadn't already written down and then [in May 1994] sent the records to Dr. Straub." Patient K. B. testified that, "the night before my surgery" [December 1994] she received a call from Dr. Fromhagen's office asking if they could send her records to Dr. Straub. In the course of that discussion, Patient K. B. advised that she had been diagnosed with breast cancer and was scheduled for surgery. That same evening, shortly after the phone discussion with Dr. Fromhagen's office, Patient K. B. went to Dr. Fromhagen's office and obtained a copy of her medical records. These records did not contain the "rewritten portions" Dr. Fromhagen reported as having been done in May 1994. Dr. Fromhagen testified that he started keeping "day sheets" when he first started practicing in 1960. The "day sheets" (Respondent's Exhibit 2) are essentially a daily calendar organized by time which lists the name of patients to be seen that day and then notes such as "ovarin cyst," "vaginitis," "preg?" These "day sheets" were not mentioned in either of Dr. Fromhagen's depositions taken in 1996 in the civil action. In Petitioner's Exhibit 10, a July 3, 1997, letter to M. S. Sutton, an Agency for Health Care Administration investigator, Dr. Fromhagen attempts to explain his record- keeping practice for patients, Dr. Fromhagen acknowledges rewriting his charts and states, "I would carefully review the chart and address any portions that I felt were not completely explanatory, or that I thought need information to assist the subsequent physician. I now understand that I should have noted the changes as late entries and dated them the date written." No mention was made of "day sheets" in this letter. Dr. Fromhagen testified during a deposition taken in the civil action that his standard practice was "to make entries in the chart right away," that he never put it off, and that he had not done anything different in Patient K. B.'s case. Dr. Fromhagen acknowledged that during a deposition taken in the civil action he had incorrectly testified that he had not made changes in Patient K. B.'s medical record. The following is a comparison of the significant difference between Petitioner's Exhibit 9, Patient K. B.'s original medical record, and Respondent's Exhibit 3, Patient K. B.'s "augmented" medical record. Please note: Patient K. B. became Dr. Fromhagen's patient on September 6, 1990. No changes were made in the "Gynecologic History and Physical Examination" (Patient K. B.'s medical record) on any entry until March 30, 1992. Changes are highlighted. Date: March 30, 1992 Original record: "Mammogram was neg. palpation indicates mass much smaller. Will follow" Augmented record: "Mammogram reported as no evidence of neoplasm. Palpation indicates to me that mass is smaller. Discussed removing it" Date: May 21, 1992 Original record: "Dysuria General Malaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Augmented record: "Dysuria. Mailaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Date: August 31, 1992 Original record: "Introital lesions. Pelvic area feels congestion and cramping sensation. Pelvic- ulcers-blisters at introitus but very small. Herpes? Rx Zoirax" Augmented record: "Introital lesions. Lower abd cramping. Pelvic - herpetic ulcers at introitus. Rx Ziorax" Date: April 19, 1993 Original record: "Last mammogram revealed no concern. Dysuria. Frequent UTI. Had a cysto before. Rhinorrhea. Vulvar irritation. GenPE. Breasts unchanged. Pelvic - fungus. Rx She has Monistat. Urine - pus Macrodantin. RV Cysto" Augmented record: "Last mammogram revealed no neoplasm but mass still present and I suggested another x-ray now or removal of mass if she wishes. Dysuria. Has frequent UTIs. Had a Cysto before. Rhinorrhea. Vulvar irritation. Gen PE - nasal turbinates swollen. Breasts unchanged. Pelvic-fungus. Rx she has Monistat for fungus. Macrodantin RV Cysto" Date: April 27, 1993 Original record: "Cysto: stricutre. Proximal urethra & trizone inflamed and granules. Bladder capacity - first desire to void at 200 c.c. RV dilations" Augmented record: "Cysto-urethral stricture. Proximal urethra & trizone inflamed & granular. Urethra L46. Bladder capacity - first desire to void at 200 cc. Rx RV dilations" Date: May 18, 1993 Original record: "No urinary complaints now. Sounded #32 irrigated AgNO3. This concludes dilations" Augmented record: "No urinary complaints now. Sounded #32, irrigated AgNO3. This concludes diations. She has not gotten this years mammogram yet" Date: October 11, 1993 Original record: "Rem sent" [entry made by office staff]" Augmented record: "Reminder note sent - Exam due." [entry made by office staff]" Date: November 16, 1993 Original record: "On Premarin.625. Starting to awaken in the middle of the night again Nervous. No flashes. Bladder OK. New glasses. Trouble adjusting to fidders bifocals. GenPE, breasts & pelvic unchanged. Pap change to Premarin 1.25" Augmented record: "On Premarian.625. Starting to awaken in the middle of the night again. Very nervous. No flashes. Bladder OK. Finds it hard to adjust to her new bifocals. Gen PE unchanged. Breasts - mass still present. Again suggested she get a yearly mammogram or have mass excised. She has not arranged for a mammogram as she said she would. Pelvic unchanged. Rx Increased dose of Premarian to 1.25" The entries made in patient K. B.'s "augmented" record (Respondent's Exhibit 3) were not noted to be "late entries" nor were they dated. Both expert witness opined that this fell below the standard of care. Most of the "late entries" made by Respondent in the "augmented" record (Respondent's Exhibit 3) are a self-serving attempt by Respondent to create the impression that he had encouraged Patient K. B. to have follow-up mammograms or to have the breast mass excised. If the "augmented" record (Respondent's Exhibit 3) was a true reflection of the treatment rendered Patient K. B. by Respondent, his treatment could possibly have met the "standard of care." I find that the "augmented" record does not reflect the treatment Patient K. B. received, but that the original record (Petitioner's Exhibit 9) is the more credible document and accurately reflects Respondent's treatment of Patient K. B. Dr. Nelson, who testified as an expert witness, testified that Dr. Fromhagen fell below the standard of care in that (relying on both the original record and "augmented" record) between March 30, 1992, and April 13, 1993, he did not "deal with the breast mass, did not report discussion of treatment options with the patient, did not order a follow-up mammogram within 12 months." Again relying on both records, Dr. Nelson testified that Dr. Fromhagen fell below the standard of care for maintaining medical records when he failed to record his examination of Patient K. B.'s breasts and palpation of the mass which he reported as having been done "every visit she made." Both Dr. Von Thron, who also testified as an expert witness, and Dr. Nelson agreed that the standard of care requires that for any revision of medical records, if a change is made, a line is made through the original so it can be read and then the correction is made and the change is dated and initialed. If an additional statement is entered into the medical record, it should be dated and initialed. Dr. Fromhagen did not date or initial the changes or additions to Patient K. B.'s medical record when he created the "augmented" record. Both expert witnesses testified that this fell below the standard of care for medical record-keeping. Dr. Von Thron, referring to the original record, opined that Dr. Fromhagen did not comply with the standard of care for essentially the same reasons as expressed by Dr. Nelson. He opined that the "augmented" record indicates that Dr. Fromhagen complied with the standard of care.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is Recommended that the Board of Medicine enter a final order finding Respondent guilty of violating Subsections 458.331(1)(k), (m), and (t), Florida Statutes (1993), and imposing the following: A $1,000.00 fine for each violation, for a total of $3,000.00; and A one-year suspension followed by two years' probation; Ten hours of continuing medical education in ethics; An appropriate medical education course in medical record-keeping. DONE AND ENTERED this 5th day of March, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of March, 2001. COPIES FURNISHED: George Thomas Bowen, II, Esquire Law Offices of Donald Weidner, P.A. 11265 Alumni Way, Suite 201 Jacksonville, Florida 32246 John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact At all times pertinent to the allegations herein, the Petitioner, Board of Medicine, was the state agency in Florida charged with the licensing and regulation of physicians in this state. Respondent, Dr. Lewis Sidney Wolf, was at all times pertinent licensed as a physician in Florida. Dr. Wolf took his medical degree at the university of Bologna, in Italy, and thereafter did his internship and residency training at hospitals in New York. He has been in the private practice of obstetrics and gynecology since 1977 and though not Board certified, has limited Board eligibility. Upon completion of the required continuing medical education courses he will be eligible to sit for the Board examination. He was employed as a physician at the Aware Woman's Medical Center, (Center), an abortion clinic in Port St. Lucie, Florida, from May, 1987 to October 8, 1990. During that time he had no responsibility for administration or the business affairs of the Center. On January 5, 1990, he saw L. S., (Patient 1), a 19 year old rather tall woman on whom he had done a previous abortion, who had come in for termination of another pregnancy. He recalls her as being normal both mentally and physically. His physical examination of the patient consisted of listening to her heart and lungs and doing a bi-manular pelvic examination. This includes placing one hand in the patient's vagina to feel the cervix and the other hand on the patient's abdomen at the top of the uterus. By doing this, the physician can see how big the uterus is and feel for any abnormality caused by pregnancy or fibroids. Respondent's examination of this patient showed she had a regular, smooth and symmetrical, if large, uterus. Since other tests had shown she was pregnant, he decided to terminate it at her request. Respondent's initial examination caused him to estimate the fetus size was larger than 9 weeks. He therefore suggested the patient be given a sonogram to determine with some accuracy how big it was. However, since the patient was so tall, and this can be deceiving as to uterus size, and because his assistant, Candace Dye, the clinic administrator who, incidentally, had no medical training, disagreed with him, and because the procedure was already scheduled and a sonogram, which had to be done outside the office, would be costly to the patient and would interfere with the scheduled procedure, he checked the patient again and concluded the fetus size was only 9 weeks. Since he felt that maybe the untrained layman was correct and since the termination procedure was the same up to 14 weeks as it was at 9 weeks, he assumed responsibility and decided to go ahead with the termination using a dilation and curettage. In this procedure, metal rods of increasing size are inserted into the cervical opening to dilate it after which a plastic tube with a hole on the side, (a cannula) is inserted into the uterus to remove the fetus by means of a vacuum aspirator, (suction). This procedure is not generally used to terminate a pregnancy of longer than 14 weeks. Page 10 of Petitioner's Exhibit 2, the patient records from the Center, reflect that Respondent's initial estimate of fetal size, as recorded by the nurse, was greater than 12 weeks and the Respondent at first ordered a size 12 cannula. However, after the cervix was dilated, Respondent ordered a 14 cannula because during dilation he felt the fetus was larger than anticipated. After the first aspiration, Respondent felt there was still some tissue left in the uterus and inserted the cannula again to get it. At this point, Respondent noticed some yellow fatty material in the aspirator which he believed came from the omentum, the outside of the uterus, and he believed that the cannula head had gone through the side of the uterus at the site of a scar from a previous caesarian section, (the patient had had two previous caesarian sections). This is the place where, according to Respondent, most perforations occur due to the weakening of the uterus as a result of those procedures. In the interim period between the removal of the cannula after the first insertion and the second insertion, because he could not get all the tissue out during that first insertion, Respondent used a placenta forceps to get the bony part of the fetus, (an arm), which would not go through the cannula. He then used the cannula the second time and cannot be sure if it was the forceps or the second application of the cannula that caused the perforation. In any case, when he realized that a perforation had occurred, he packed the uterus with gauze and called 911 to have the patient taken to the hospital. She subsequently recovered but lost one tube. Patient 2, a 41 year old female, reporting two prior deliveries, came to the Respondent for a pregnancy termination on October 28, 1989. At the time, she seemed quite nonchalant about the whole process. She reported having a fibroid uterus and claimed to have had a recent sonogram which showed a "VBD" of 5.1. The term "VBD" is incorrect for use in connection with a sonogram. The appropriate initials are "BPD", bi-parietal diameter, and a BPD of 5.1 correlates to a fetus age of in excess of 21.5 weeks. The patient also indicated that she had only had sexual relations twice in several years, the last of which was consistent with a pregnancy of far less duration that 20 weeks. Respondent did a bi-manular examination and estimated from that a gestational age of the fetus of 20 weeks. However, the patient's forms showed a sonogram had been done on October 21, 1989 and the uterus size given as a result thereof was 9. Respondent claims his estimate of 20 was for the uterus size, not the fetus size, and this is not inconsistent with the diagnosis of fibroid uterus which could, of itself, considerably increase the size of the uterus. In addition, Respondent claims his examination showed the uterus to be firm and in pregnancy, the uterus generally gets soft. Based on all the above, and given the fact that the Patient could not recall where the sonogram had been done, and the fact that she seemed reliable to him, Respondent concluded that the pregnancy was of only 9 weeks duration and agreed to terminate it by dilation and curettage. His description of the patient as reliable is not consistent with his other comments regarding her at the hearing wherein he described her as inconsistent and mixed up. In retrospect, at the hearing, he admitted he now realizes she was lying to him. As Respondent was preparing the patient for the procedure, he noted on her chart that the sonogram showed 5.1. This figure represents the diameter through the head of the fetus. He did not have a chart handy from which to extrapolate the sonogram figure to a fetal age. He asked his assistant, Michelle Trent Wimble to check it. She left the room and when she came back reportedly stated, "It's OK - it's only 11 weeks." In reality, Ms. Wimble did not look at the correct chart and the information she gave to the Respondent was incorrect. He did not verify it. In the termination, Respondent started with a size 12 cannula. Once the vacuum was initiated with that cannula, he shifted to a 14 and then requested a placenta forceps. He changed the size because, he asserts that once the patient was dilated, he realized the fetus was larger than he had anticipated and needed the larger size. Also, when he saw the amniotic sac he knew the pregnancy was further along than 11 weeks but because he was committed and could not let the patient go home like that, he had to continue. He broke the sac and tried to vacuum with a 16 mm cannula, the largest made, but was still unsuccessful. He then tried the forceps. When he saw the umbilical cord had prolapsed, and had removed a hand from the fetus, he knew it was much older than anticipated. Since it was obviously beyond the 14 weeks menstrual limit the Center set for abortions there, he called 911 to have the patient taken to the hospital for completion. Respondent has specialized in abortions not only for his 3 years at the Center, but at other clinics in New York, Tampa and Ft. Myers, where he filled in for another physician whose license was under attack. He has done over 5,000 abortions and claims to have experienced complications in only 4 of them. Each of these involved perforations of the uterus. According to Ms. Dye, who worked with Respondent for the three years he was at the Center, his problem rate was low. A perforation may occur as the result several different factors such as a tilting of the uterus or frequent prior pregnancies which weaken or soften the wall of the uterus. A perforation is also more likely in a woman who has had one or more caesarian sections. It is not necessarily due to negligence on the part of the physician though it may be. According to Respondent, most often it is not negligence but more a complication which occurs because of the anatomical arrangement of the pelvic organs. With regard to Patient 1, Respondent feels he did nothing wrong. Her records show that from her last menstrual period she would be 11 weeks pregnant based on her last period date of November 1, 1989. Also, from her history sheet he notes 2 reasons for her being a higher risk patient. She had had two caesareans sections and one prior abortion. She was 19 years old and had had 5 pregnancies. Therefore, he claims, her uterus had not had time to rest and could easily be perforated. In addition, as a result of his examination, he was quite comfortable with a 9 weeks fetal determination. Though she might have been slightly over that she was still within the limits for a suction abortion. He is also comfortable having done the bi-manual examination which he feels is generally reliable. Factors such as a tall patient can throw it off, however, he claims. With regard to Patient 1, Respondent claims there was nothing about her to alert him to danger. It is not usual to change cannulas in mid- procedure. It is done from time to time, especially in the first pregnancies of young women whose cervix are hard to dilate. He also claims it is not unusual to over or under estimate a pregnancy by 2 weeks. It is impossible to tell exactly how many weeks a patient is pregnant. Respondent admits a patient history sheet is important and it is important that the patient give honest information for it. Erroneous information from any source, if relied on by the physician, can result in injury to the patient. Patient 2 was a 41 year old woman at the time he saw her. This fact makes her a high risk patient for carrying the fetus to term. From the last menstrual period she reported, she would be 12 weeks pregnant. The sonogram results as passed to the Respondent was consistent with 11 weeks of pregnancy and with the menstrual history. Assuming her sexual history were correct, she could be no more than 16 weeks pregnant. Because the patient referred to a "VBD", similar in sound to "BPD", the correct term, Respondent considers it was reasonable for him to believe she had had a sonogram. Here, however, the Respondent stated at one point that at that time he did not believe her and if that is the case, it was improper for him to do the procedure on a patient who he did not believe had given him a correct history. Further, when a patient shows a history of prior pregnancies or caesarian sections, admittedly that patient is at a higher risk of perforation and the doctor should be more cautions and more prepared than otherwise. Respondent's performance in the two cases at issue here was reviewed by Dr. Edward J. Zelnick, himself an expert in the field of obstetrics and gynecology, who has done numerous pregnancy terminations in the past. His review consisted of an examination of the clinic and hospital records of both patients. In order to safely and properly terminate a pregnancy, it is necessary for the physician to know the size of the fetus. This can be determined by the history taken from the patient, by physical examination of the patient, including both palpation and bi-manual manipulation, and by sonogram. In the case of patient 1, Respondent performed a suction curettage. Before doing so, he accomplished a bi-manular examination and determined the fetus was 9 weeks of age. The records reflect that initially an ultrasound, (sonogram), was requested, but that order was rescinded. In the suction curettage the cervix is dilated with metal rods of increasing diameter and the cannula is then inserted to remove the fetus by suction. The size of the fetus determines the size of the suction tube to be used. Here, Respondent selected an 11 cannula which can be used generally with fetuses from 9 to 11 weeks of age. The records reflect that little tissue was obtained through the use of the cannula, so Respondent asked for and used a larger one. After the size of the cannula was increased, a placental forceps was used to remove a fetal extremity and a portion of the oventum, (a portion of fact attached to the intestine not generally found in the uterus). The presence of the oventum indicates that the wall of the uterus was perforated. Dr. Zelnick feels this perforation could have been avoided if more care had been utilized in the determination of the fetal size. There appeared to be a discrepancy between the appearance and the actual size and duration of the fetus. If the size was, as here, underestimated, the larger actual fetus prevented the doctor from getting the amount of tissue he expected. This could lead him to go deeper or in a different direction that she should go to get tissue. In light of this, Dr. Zelnick opined that the level of care rendered to Patient 1 by the Respondent was below standard because the final outcome and the manner of performance is not properly reflected in the records. Also, the wrong size instruments were used. Most important, however, is the failure to properly determine the size of the fetus. If the doctor is unsure of the fetal size, he should take further steps, through ultrasound or otherwise, to be more specific. Here, in Zelnick's opinion, the perforation occurred when the Respondent went into the uterus with the placental forceps. Once the perforation was noted, Respondent properly had the patient taken to the hospital where her abdomen was opened and her right fallopian tube and ovary were removed. In addition, her uterus was repaired. All this resulted in her being exposed to risk due to anesthesia, infection and hemorrhage. In addition, she unnecessarily lost her tube and ovary due to the bleeding caused by the perforation. Since she now has only one tube and ovary, there is a possible diminishment in future fertility, but there is some doubt as to that happening. As to Patient 2, according to Dr. Zelnick, the Respondent established she was 9 weeks pregnant. The records show the result of the bi-manual examination showed 9 weeks, but they also reflect the patient had a sonogram and to Dr. Zelnick, it is unclear because the record of the sonogram showed a 5.1 BPD which is consistent with a 20 - 22 week pregnancy. In addition, the patient gave a history of only 2 sexual relations prior to the visit which is inconsistent with the other findings since the last intercourse would have been to 15 weeks prior to the visit which would not fit with a 9 week fetus finding. The nurse's note on the patient records indicate the only information the patient could give was that the sonogram showed a 5.1 LMP [sic]. In this case, Respondent also did a suction curettage initially using an 11 cannula. He then requested a 12 cannula and almost immediately went to a 14 which he then increased to a 16 which would be used for a 14 - 16 week fetus. When he failed to get an adequate tissue return, he used a placental forceps and saw a fetal extremity and umbilical cord. When he saw this, he realized the pregnancy was further advanced than expected and stopped the procedure and called for emergency services. This patient was also given an injection of Petosin, a drug used to contract the uterus, and an intravenous was attempted. She was taken to the hospital and treated for hemorrhage, hypertension and shock, and failure of her blood to coagulate. Hypertension is consistent with blood loss and it was subsequently noted in surgery that the patient had a uterine perforation. The patient was given an exploratory laparotomy and a total abdominal hysterectomy. The danger of anesthesia, infection, hemorrhage, and the loss of fertility as a result of the removal of her uterus are all negative results of the procedure. Dr. Zelnick is of the opinion that Respondent's treatment of patient 2 was below acceptable standards because the Respondent had an obligation to be certain of the age of the fetus before initiating action and did not do so. His omissions led to an unfortunate series of events which injured his patient. In fact, Dr. Zelnick goes so far as to classify Respondent's actions as gross negligence. The relative sizes of a 9 week and a 22 week fetus is so disparate that such a mistake as here is not reasonable. While a 9 week fetus is about the size of an orange, a 22 week fetus is about the size of a volley ball. While the existence of a uterine fibroid cyst can make the determination of fetal size more difficult, a doctor can make the determination. A fibroid cyst is hard and solid while a fetus is soft. In any case, if there is a question, a sonogram should be done. If the physician cannot be absolutely sure of the length of gestation by examination or history, he should take all necessary other steps to find out. If he does not, his failure constitutes negligence. Here, especially, the inconsistent BPD value, a figure with which any doctor routinely doing abortions should be familiar, should have tipped Respondent off to the need for more information. In addition, according to Dr. Zelnick, the Respondent's record keeping was poor. They do not accurately reflect or justify the procedures done on this patient. Dr. Zelnick admits that a uterine perforation is a complication which can occur without negligence on the part of the physician. Certain conditions, including an abnormality of the uterus can increase the risk, and by itself, a perforation is not necessarily bad care. If a patient has had 2 prior caesarian sections and 3 pregnancies, an attending physician could easily be slightly off in the age of the fetus. However, a doctor, as here, who does many abortions should be better at estimating the length of a pregnancy than one who does fewer. Respondent's expert, Dr. Dresden, also a Board certified obstetrician and gynecologist, who has performed over 10,000 abortions during his medical career, appeared on Respondent's behalf because, inter alia, he believes there is a grey area in the practice of medicine to which, in his opinion, the Department is not sensitive. It does not recognize differing methods of practice. He also contends that the mere fact a complication occurs which must be reported does not justify an indictment of the practitioner. Disciplinary action, in his opinion, should be reserved for cases of misconduct. As to Patient 1, Dr. Dresden feels that bi-manual examinations are quite difficult to do and are quite often inaccurate as to the length of gestation. The mistake made by Respondent here, as to the size of the fetus, is common. As to Patient 2, Dr. Dresden could see no reason for another ultrasound being taken. The government does not normally reimburse for it, and if, as here, he had found the incorrect estimate had been made and the instrument he was employing was too small, he'd go on with the procedure with a larger instrument. The is no relationship between the mis-diagnosis of size of the uterus and the risk of perforation except that there would be a greater weakness in the uterine wall in the case of a 20 week pregnancy. However, even a prudent doctor could end up perforating the wall of a uterus for a myriad of reasons. The position of the uterine cavity may be out of line, and if the instrument is not properly lined up, there is a greater risk of perforation. Also, a pregnant woman has softer uterine walls that are more easily perforated than a non- pregnant woman. Dr. Dresden could see nothing that Respondent could have done to avoid the perforations here nor does he believe Dr. Zelnick could accurately determine, from looking at the records, what instrument caused the perforation. If Patient 2 said she had had an ultrasound, he probably would have believed her. Most patients do not know enough to make up a story like that, he believes, and if he saw a record that the BPD was 5.1, he would ask a nurse or an assistant to look up the meaning of that reading and would rely on it. Here, based on what information he had about Patient 2, the 4 factors he took into consideration being better than the usual 2, he believes Respondent could have reasonably relied on the stated size of the fetus. He cannot say that Respondent used poor judgement in these cases notwithstanding his comment to the contrary in a prior letter to the Department regarding this case. By the same token, he cannot see any errors in Respondent's performance other than the mis-diagnosis of fetal size. The witness' prior professional record and his obvious antipathy toward the enforcement activities of the Department, cast some doubt on the value of his testimony, however. No evidence was presented with regard to the medical records of either patient in issue here to bear on the issue of their adequacy or inadequacy. Dr. Zelnick commented on his opinion that the records were poor, but no specific evidence of inappropriate recordation of the patients' conditions or other relevant matters was submitted to show them to be inadequate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent's license to practice medicine in Florida be suspended for a period of six months and until such time as he has satisfactorily completed the special purpose examination of clinical skills; that upon reinstatement of his license, he be placed on probation for a period of two years under such terms and conditions as is considered appropriate by the Board of Medicine; and that he pay a fine of $1,500.00 within six months of the reinstatement of his license. DONE and ENTERED in Tallahassee, Florida this 17th day of December, 1991. 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 17th day of December, 1991. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 91-2969 The following constituted my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all the Proposed Findings of Facts submitted by the Petitioner herein. Respondent failed to submit Proposed Findings of Fact. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 10. Accepted and incorporated herein. 11. & 12. Accepted. Rejected. - 27. Accepted and incorporated herein. Rejected in that the Respondent's failure to ascertain the results of the sonogram is not evidence of poor record keeping. Rejected in that Respondent's failure to ascertain the gestational age of the fetus when facing conflicting information is not evidence of poor record keeping. & 31. Accepted and incorporated herein. COPIES FURNISHED: Larry McPherson, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dr. Harold J. Ticktin 2106 Drew Street, Suite 102 Clearwater, Florida 34625 Jack McRay General Counsel DPR 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The ultimate issues in this case are whether Respondent violated Section 458.331(1)(m) and (t), Florida Statutes (1997), respectively, by failing to keep medical records that justify the course of treatment and by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances; and, if so, what penalty, if any, should be imposed against Respondent's license to practice medicine. (All chapter and section references are to Florida Statutes (1997) unless otherwise stated.)
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43 and Chapters 455 and 458. Respondent is licensed as a medical physician in Florida pursuant to license number ME0050478. Respondent has been a Board-certified plastic surgeon at all times material to this proceeding. The Administrative Complaint involves one patient who undertook elective plastic surgery. The record identifies the patient as E.O. in order to preserve the patient's confidentiality. In summary, the Administrative Complaint alleges that Respondent departed from the acceptable standard of care by: failing to perform the surgical procedure elected by E.O.; performing a surgical procedure other than the procedure E.O. authorized; failing to document a reason for changing the procedure; failing to advise the patient of the risks associated with the procedure performed; performing breast augmentation with implants that were too large; and failing to document a reason for using the larger implants. On December 31, 1997, E.O. presented to Respondent for consultation regarding reconstruction of her left breast. At the time, E.O. was approximately 48 years old. E.O.'s medical history included an abdominal hysterectomy, a biopsy of the right breast, two biopsies of the left breast, and a diagnosis of cancer in the left breast. A partial mastectomy of the left breast and radiation therapy resulted in significant scarring. The left breast had a concave, depressed area in the left side. The depressed area extended from the upper part of the breast, near the outer pectoral muscle, halfway to the nipple. The nipple on the left breast was pulled to the outside toward the depressed area. E.O. also suffered ptosis, i.e., the appearance of drooping, that was not related to her medical history. The radiation therapy to the left breast had caused a burn injury that left internal scar tissue. The scar tissue was not pliable and was not suitable for manipulation during plastic surgery. During E.O.'s initial visit with Respondent on December 31, 1997, Respondent noted E.O.'s prior medical history and radiation treatment. He noted the bilateral ptosis and the left breast deformity. Respondent recommended bilateral implants for the purposes of reconstructing the left breast and for achieving symmetry between the breasts. Respondent and E.O. did not agree on a plan of treatment during the initial visit but did agree to a second visit. On January 16, 1998, E.O. presented to Respondent for her second visit. After further consideration of E.O's case, Respondent made a specific recommendation of bilateral augmentation with prostheses, in the form of implants, and a latissimus dorsi flap (LDF) procedure to correct the depression in the left breast. An LDF procedure would have resected, or removed, the scarring in the left breast and would have replaced the resulting divot with healthy tissue. Respondent would have obtained healthy tissue by moving a flap of tissue and muscle from the patient's back underneath the patient's outer tissue layers and placing the flap internally in the left breast. E.O. agreed with Respondent's recommendation. E.O. agreed to the bilateral augmentation because Respondent advised her that an implant in her right breast was necessary to achieve appropriate symmetry. E.O. did not agree to the augmentation because she wanted larger breasts. Respondent assured E.O. that her breast size would increase only about one-half cup. Respondent's records do not include a reference to the size of the implants to be used. Respondent indicated he would seek preauthorization from the insurer for the LDF procedure with prosetheses. The LDF procedure required E.O. to stay overnight in the hospital following surgery. Surgery that omitted the LDF procedure could have been performed in "same-day" surgery. Respondent and E.O. did not discuss or agree upon any plan of treatment. On January 21, 1998, E.O. presented to Respondent for a third time. E.O.'s husband, L.O., was also present. Respondent discussed the LDF procedure with E.O. and L.O. Respondent stated that he believed the LDF procedure was necessary to fill-in the left breast after Respondent resected the radiated tissue as part of the reconstruction of E.O.'s left breast. Respondent, E.O., and L.O. did not discuss other treatment options. On January 21, 1998, Respondent requested authorization from E.O.'s insuror for breast reconstruction surgery that included an LDF procedure with the use of a prosthetic implant. On February 12, 1998, E.O. presented to Respondent for a fourth time. E.O. had additional questions about the surgery that included questions regarding the insurance coverage for the surgery. E.O. and Respondent did not discuss the LDF procedure or other treatment options. Respondent scheduled the surgery for February 26, 1998, at the Columbia Regional Medical Center Southwest Hospital ("Columbia" or the "hospital"). On February 24, 1998, E.O. presented to Columbia for a preoperative workup. At the preoperative workup, E.O. executed a written informed consent document that authorized Respondent to perform a, "Lat Flap with implant left Breast and Right endoscope augmentation." Respondent also signed the informed consent. E.O. did not consent to another procedure different from that stated in the informed consent. Nor did E.O. and Respondent agree upon a different procedure. Hospital records, including the Short-Stay History and Physical completed on the day of surgery and signed by Respondent, show that the procedure to be performed was an LDF procedure with implants. The hospital records are devoid of any indication that E.O. did not wish to undergo the LDF procedure or that E.O. expressed any reservations about the procedure. On the morning of February 26, 1998, E.O. fully expected to undergo the LDF procedure. E.O. presented to Columbia anticipating an overnight hospitalization that was consistent with an LDF procedure. E.O. brought with her the personal belongings she would need for an overnight hospitalization. The applicable standard of medical care required Respondent to perform the LDF procedure so long as it was medically reasonable to do so. On February 26, 1998, Respondent performed surgery on E.O. that included an implant in each breast. However, Respondent did not perform the LDF procedure. Rather, Respondent created breast flaps by incising existing scar tissue and utilizing the incised scar tissue to fill in the depression in the left breast. Respondent did not resect the scar tissue and replace it with healthy tissue. Immediately after the surgery, Respondent advised L.O., without explanation, that Respondent did not perform the LDF procedure and that E.O. was doing well. Columbia discharged E.O. on the same day of surgery. During the trip home in their car, L.O. advised E.O. that Respondent did not perform the LDF procedure. E.O. was surprised but groggy from medication. No medical reason prevented Respondent from performing the LDF procedure. Respondent encountered no difficulties or complications during surgery that precluded the LDF procedure. Moreover, there were medical reasons not to incise the scar tissue and use it to fill in the depression in the left breast. Irradiated scar tissue is not well vascularized, is not pliable, and is not easy to manipulate. The only reason that Respondent offered for failing to perform the LDF procedure was that E.O. expressed concern over the procedure. Respondent testified that E.O. expressed her concern to Respondent when Respondent was in the holding area marking E.O.'s breasts for surgery. The holding area is an area that is physically separate from the operating room. E.O. did not expressly ask Respondent not to perform the LDF procedure. Rather, Respondent inferred that E.O. did not want him to perform the LDF procedure. As Respondent testified during cross examination: Q. And you had a conversation with her wherein she expressed some concern about the latissimus dorsi flap procedure; is that correct? A. The tenor of her conversation indicated some concern. She did not say to me please don't do it, but the tenor of her conversation was that there was concern when I was marking her for it. Transcript (TR) at 624. Respondent claims that the conversation with E.O. occurred when Respondent was in the holding area marking E.O. for surgery. Respondent's testimony during cross examination is illustrative. Q. And your testimony is that, is the holding area an area different than the actual operating room. A. Yes. * * * Q. I would like for you to look to the first line of this operative report, under procedures. It says the patient was brought to the operating room, and marked in the sitting position, then laid supine. A. Yes. Q. Doesn't that note say that you did not mark this patient in the holding area, but you marked her in the operating room? A. It sure does. And are you telling me today that this is in error? A. That is absolutely in error. I have never marked a patient in the operating room. TR at 625. Respondent's claim that he had a conversation with E.O. in the holding area before surgery is refuted by E.O. The testimony of E.O. concerning this factual issue is credible and persuasive. The testimony of E.O. is consistent with the operative report stating that E.O. was marked in the operating room rather than in the holding area. Respondent did not see E.O. in the holding area prior to surgery and did not have a conversation with E.O. in which E.O. expressed some concern over the LDF procedure. E.O. received preoperative medication in the holding area and was not capable of carrying on a conversation with Respondent in the operating room and was not capable of making an informed consent to a different procedure. If it were determined that Respondent had a conversation with E.O. in the holding area while marking her for surgery, there was ample time to amend the informed consent document to reflect a different treatment plan agreed to by E.O. and Respondent. The actual surgery performed by Respondent was a procedure that was different from the LDF procedure authorized by E.O. The actual surgical procedure performed by Respondent was not a lesser included procedure of the LDF procedure. The applicable standard of care would have required Respondent to amend the informed consent document under the facts and circumstances testified to by Respondent. An informed consent should include all anticipated treatment options. The informed consent signed by E.O. and Respondent did not include any options to the LDF procedure. Even if it were determined that the actual procedure performed is a lesser included procedure of the LDF procedure, E.O. did not consent to the lesser included procedure. The performance of a lesser included procedure for which E.O. was not informed and to which E.O. did not consent departs from the applicable standard of care. The procedure performed by Respondent during surgery increased the risk of failure and the need for subsequent surgery by using scar tissue rather than resecting the scar tissue and using healthy tissue to fill in the left breast. Respondent failed to inform E.O. of the increased risk of the procedure actually utilized by Respondent. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. First, Respondent failed to perform the procedure that E.O. authorized. Second, Respondent performed a procedure that placed implants in E.O.'s irradiated left breast without resecting the irradiated scar tissue. Third, Respondent failed to inform E.O. of the increased risk associated with the procedure Respondent utilized during surgery. Finally, Respondent failed to document in the records a reason or rationale for performing a surgical procedure other than the LDF procedure authorized by the patient. Prior to surgery, Respondent agreed to use the smallest implants possible. During surgery, Respondent placed very large implants in E.O.'s breasts. Respondent used a 480 cc implant in the left breast and a 460 cc implant in the right breast. Respondent used the large implant in the left breast, rather than the LDF, in an attempt to stretch the tissue, including the scar tissue, and to fill in the depression in the left breast. Respondent used the large implant in the right breast for symmetry. E.O. did not consent to the use of large implants in either breast. Rather, E.O. authorized the smallest implants possible. Respondent utilized implants that increased E.O.'s cup size from a small C cup to a DD cup. The weight and volume of the large implants stretched E.O.'s skin and exacerbated her ptosis. After surgery, E.O.'s clothes did not fit. A DD cup size was sometimes too small. An accepted method of determining the effect of implants is to sit the patient up on the operating table prior to completing surgery. Respondent did not sit E.O. up on the operating table to view the effect of the implants. Respondent had a complete range of implant types and sizes available for use during surgery. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. Respondent utilized implants that were not authorized by E.O. by placing overly large implants in E.O.'s breasts. Respondent failed to utilize the implants authorized by E.O. by failing to use the smallest implants possible. Respondent failed to document in the records a reason or rationale for using implants other than those authorized by E.O. Respondent's failure to practice medicine in accordance with the applicable standard of care caused substantial harm to E.O. At the first postoperative visit on March 2, 1998, E.O. asked Respondent why he did not perform the LDF procedure. Respondent stated that he had determined that E.O. could do without the LDF procedure. E.O. also expressed concern over the large size of her breasts. Respondent explained that the large size was attributable to swelling and that it would take several months for the swelling to dissipate. Until that time, it was impossible to assess the final result. During subsequent visits on March 11 and 18 and on April 3, 1998, E.O. expressed concern over the size and appearance of her breasts. However, she continued to trust Respondent and to accept his assurances that she needed to be patient and allow the swelling to go down before forming any final opinions regarding the outcome of the surgery. During a visit on May 1, 1998, Respondent examined E.O. and acknowledged that the procedure actually performed on February 26, 1998, did not produce the desired result. The implant and incised scar tissue had not stretched and filled in the left breast. Respondent advised E.O. that she needed the LDF procedure. E.O. elected for Dr. Brueck to perform reconstruction surgery on her. However, problems with insurance coverage delayed the surgery until July 11, 2000. The surgery included bilateral reconstruction with bilateral implant and mastopexy. E.O.'s breast size was a B cup after surgery. E.O. was very pleased with the results of the surgery.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, in accordance with the terms of Petitioner's PRO, that Petitioner enter a Final Order finding Respondent guilty of violating Section 458.331(1)(m) and (t); issuing a written reprimand; imposing a fine of $5,000; and requiring Respondent to complete, within one year, 20 hours of continuing professional education above and beyond that required to maintain licensure. DONE AND ENTERED this 18th day of March, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of March, 2002. COPIES FURNISHED: William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Britt Thomas, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Carol A. Lanfi, Esquire 1000 Riverside Avenue, Suite 800 Jacksonville, Florida 32204 Albert Peacock, Esquire 8554 Congressional Drive Tallahassee, Florida 32312 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. He holds License No. ME 0019700. Respondent received his medical degree overseas and did his residence in obstetrics and gynecology at Bayfront Medical Center in St. Petersburg, Florida. He is neither board certified nor board eligible. For the past eight plus years Respondent's practice has been limited to terminating pregnancies at All Women's Health Clinic at Tampa, Florida. He has performed in excess of 15,000 abortions. One reason given by Respondent for so limiting his practice is the cost of medical malpractice insurance. Since he has no private practice, Respondent gave up admitting privileges at hospitals in the area. Without malpractice insurance, he would not be given staff privileges. On August 23, 1986, A. L., a pregnant 16 year old, entered All Women's Health Center, Tampa, to have her pregnancy terminated. A. L. had noted on her history statement that her last menstrual period started some eight weeks ago. Respondent first saw A. L. when he entered the procedures room at All Women's Health Center and commenced his examination prior to instituting abortion procedures. With respect to the examination the testimony varied widely. Diane Roberts, LPN, who was performing the duties of physician's assistant during the procedure, initially told the investigators that the examination lasted only a couple of seconds and consisted of a vaginal examination with two fingers of the right hand in the vagina while the abdomen was palpated with the left hand. At the hearing, Roberts testified that she wasn't paying much attention to the patient during the examination, didn't recall telling investigator the examination only took a couple of seconds, and recalled Respondent telling A. L. several times to relax. Respondent testified he performed a normal vaginal examination. The examination was longer than usual because A. L. wasn't relaxed and tensed her stomach muscles which made the uterus more difficult to palpate; and that following his examination he determined the gestational age of the fetus to be 12 weeks. Respondent testified he also checked the patient's heart and lungs before commencing the pelvic examination. A. L. testified that Respondent palpated her abdomen with two hands, but did not check heart and lungs or do a pelvic examination. A. L. had an earlier pregnancy terminated the previous year when the doctor did a pelvic examination with two fingers in the vagina while the abdomen was palpated with his other hand. The patient was ultimately determined to be 28 to 30 weeks pregnant. Largely because of the large error in gestational age, it is concluded that Respondent performed only a perfunctory examination on A. L. Had he conducted the proper examination, it is inconceivable that he, an experienced gynecologist, could underestimate the gestational age of the fetus by some four months. The magnitude of this error is illustrated by Respondent's testimony that a 12 week fetus is approximately 3 inches long and weighs 30 grams, while a 28 week fetus is approximately 14 inches long and weighs 1100 grams. Respondent started the procedure thinking he was aborting a 12 week fetus with the patient on the table and feet in the stirrups. After the instruments were inserted and the procedure started, Respondent concluded the fetus was 16 weeks, obtained a larger curette, then determined the fetus was more likely 20 weeks, again changed curette, and after removing fluid and part of an arm Respondent concluded that the gestational age of the fetus was some 28 weeks and required hospitalization to complete the procedure. Mistakes in determining gestational age can be made by a prudent physician if: (1) the patient is obese; (2) if the uterus is very soft and the extremities difficult to locate; (3) if the baby has a low fluid volume; (4) if the patient is very tense; or, (5) if the head of the fetus is felt and not the uterus. Here A. L. was more thin than obese which should have greatly facilitated palpation of the abdomen to determine the size of the uterus. Accepting the testimony that she was tense during the examination, and the earlier pregnancy would cause the uterus to be soft, no experienced gynecologist should conduct an examination of a patient such as A. L. and err on the magnitude here involved. Further, if the examination was difficult, the procedure should not have commenced until Respondent was reasonably positive of the gestational age of the fetus. One indication Respondent received that the fetus was older than 12 weeks was the quantity of fluid drawn. Further, no experienced gynecologist should mistake the head of the fetus as the extremity of the uterus on a patient such as A. L. Once Respondent determined the fetus was more than 16 weeks along, he called Dr. Barile, a gynecologist with admitting privileges at Humana Women's Hospital, Tampa, to request he remain available in case Respondent needed to send A. L. to a hospital. When Respondent determined the gestational age of the fetus' was more than 26 weeks, he again called Barile who suggested it would be better to refer the patient to an obstetrician. Respondent then telephoned his backup obstetrician and found she was on vacation, and a doctor with whom Respondent was not acquainted was taking her calls. Since A. L. was stable and in no apparent distress, Respondent called Dr. Klein, a pediatrician with admitting privileges at Bayfront Memorial Hospital in St. Petersburg. Dr. Klein agreed to take care of the patient by having his associate, who had the duty that day, meet the patient at Bayfront. A. L. had been brought to the clinic by her brother, and Respondent concluded A. L. could be safely transported to Bayfront by automobile and suggested her brother drive her. The brother demurred on the ground that his car overheated and might not make the 40-odd mile trip to Bayfront safely, but another brother had a more reliable car. The other brother was called and agreed to take his sister to Bayfront and stated that he would be at the clinic in about 10 minutes. Approximately 1 hour and 15 minutes later this brother arrived, and A. L. was started to the brother's car. At this time she appeared unsteady, and Respondent concluded she should go to Bayfront by ambulance. When a Hillsborough ambulance service was called, they told Respondent of the policy whereby they could not transport a patient out of Hillsborough County and that he should contact a Pinellas County ambulance service to perform the desired transportation. Respondent then called a Pinellas County ambulance service who arrived about an hour later to take A. L. to Bayfront where she was met by Dr. Yeshnick, the associate of Dr. Klein, who admitted the patient. Between the time Respondent determined the abortion could not be performed at the clinic until A. L.'s arrival at Bayfront Hospital, some 6 hours had elapsed. Of the approximately 15,000 abortions that Respondent has performed, less than 5 became emergencies that required removal from the clinic to a hospital. Respondent's backup procedures for emergencies were adequate. On August 23, 1986, A. L. was in the third trimester of her pregnancy, and the abortion was not necessary to save the life or preserve the health of A. L.
Findings Of Fact Respondent is a lay midwife licensed by the state of Florida. She has practiced as a licensed lay midwife in Florida since 1981. Respondent began her training in Boston, Massachusetts, in 1975 when she began participating in an apprenticeship program under the supervision of two Board-certified obstetricians. That training lasted for three years and included self-study, seminars, and workshops. As part of that apprenticeship program, Respondent delivered one hundred babies under the supervision of those physicians. After moving to Florida, Respondent obtained her license as a lay midwife after attending fifteen births under the supervision of a physician and after taking a written and oral examination. Since being licensed in Florida, Respondent has attended and graduated from the South Florida School of Midwifery. She has subsequently been a preceptor and instructor at that School and is on the Board for the School. At the time of the final hearing in this cause, Respondent was only two months away from receiving her nursing degree. Respondent is a member of the Midwives Association of Florida. During the course of her licensure in Florida, Respondent has attended all types of continuing education programs, particularly in the field of maternal and child health. While licensed in the state of Florida, she has attended between five hundred and seven hundred births, sometimes as the primary caregiver, sometimes assisting other midwives, and sometimes assisting physicians during hospital births. At all times material hereto, Respondent has maintained an ongoing relationship with Dr. Atilla Eagleman, an obstetrician and gynecologist. She frequently consulted with Dr. Eagleman, and he performed risk assessments on Respondent's patients. In other words, Dr. Eagleman was Respondent's "back-up" physician. Dr. Eagleman became Board-certified in December, 1990. When patient Sandy Freireich first consulted with Respondent on May 11, 1989, Freireich was seventeen to eighteen weeks pregnant with her fourth child. Respondent told Freireich that in order for her to be accepted as one of Respondent's patients, she needed to provide Respondent with proof that she had obtained an initial risk assessment by a physician. Freireich told Respondent that she had obtained that examination from her regular doctor who was an obstetrician and that she would bring Respondent a copy of her medical records documenting that examination on her next visit. Since Respondent performs an initial risk assessment on her patients, she did so with Freireich and determined that she was a low-risk patient. On at least seven occasions, Respondent told Freireich that Freireich had to provide Respondent with a copy of the initial risk assessment records from Freireich's physician. On each occasion Freireich promised to provide such a record. Respondent also strongly encouraged Freireich to see Dr. Eagleman and have him perform an initial risk assessment. Freireich agreed to do so. Respondent also requested permission from Freireich to allow Respondent to obtain Freireich's records directly from Freireich's doctor by having Freireich sign a medical records release form. Freireich insisted that she wanted to speak to her physician to make sure her doctor understood rather than simply sending him a form to release her records. Along the way Freireich missed several appointments with Respondent. For those appointments which she kept, she failed to bring with her the promised documents. On September 6, 1989, when Freireich was 32.4 weeks pregnant, she signed a medical release form authorizing Respondent to obtain her medical records directly from her doctor. On that visit, Respondent recommended to Freireich that she obtain her third trimester risk assessment from Dr. Eagleman. On September 14, 1989, Respondent received records directly from Freireich's obstetrician. Those records did not contain an initial risk assessment for Freireich's current pregnancy. On September 20, 1989, when Freireich was 34.4 weeks pregnant, Respondent caused Freireich to receive a risk assessment and a physical and prenatal examination by a certified nurse midwife in Respondent's office. That risk assessment also revealed that Freireich was a low-risk patient. It is unknown whether Freireich ever obtained an initial risk assessment during her first twenty-eight weeks of pregnancy. It is uncontroverted, however, that Respondent never received proof of such an initial risk assessment by a physician or by a certified nurse midwife. Furthermore, it is clear that Respondent consistently encouraged Freireich to obtain an initial risk assessment by a physician, and that it was Freireich who failed or refused to provide proof that such had been performed. In 1987 the Department proposed a number of changes to the rules regulating the practice of midwifery. The Florida Midwives Association challenged the proposed rules, and the Association and the Department engaged in a long-term dialog thereafter. New rules did not become effective until 1991. Although there were existing rules in place during that interim period, it became a common practice for midwives to contact Anne Richter, a consultant for the Department's midwife program. Based upon the information provided to her by a midwife, Richter would tell the midwife to care for a particular patient pursuant to the existing rules or pursuant to the proposed rules. It was common knowledge among the midwives in the state of Florida that the Department was informally allowing midwives to practice under the proposed rules rather than the existing rules and that one could call Anne Richter to obtain a "waiver" of rule requirements. On one occasion, Respondent had telephoned Richter regarding a patient who had come to Respondent when she was thirty weeks pregnant and had not obtained an initial risk assessment during her first twenty-eight weeks of pregnancy. Richter told Respondent that it was permissible for Respondent to accept that patient whose only risk factor was starting care after twenty-eight weeks. Respondent did not accept that patient. Although Respondent had intended to telephone Richter to seek permission to continue providing care to Freireich, Respondent neglected to do so. On October 30, 1989, Freireich left a message cancelling her appointment for that day. Later that afternoon she contacted Respondent to advise Respondent that she was in labor. She declined to allow Respondent to come to Freireich's home until after 8:30 p.m. because she wanted her other children to be asleep before Respondent got there. Respondent arrived at the Freireich home at 8:50 p.m. She assessed Freireich's labor, performed a physical examination, and began attending to Freireich's needs during labor. At 11:30 p.m., the fetal heart rate was 150. The patient took a shower. When she finished her shower at 11:50 p.m., Respondent checked the fetal heart rate and found that it had decreased to 90. Respondent appropriately instructed the patient to lay on her left side and gave her oxygen at six liters since the deceleration in the heart rate may have been indicative of a problem that needed to be rectified. At 11:53 p.m., Respondent appropriately checked the fetal heart rate and again found that it was 90. Respondent then assessed the patient and found the patient to be fully dilated with the baby at between 0 and +1 stations. Since the patient was fully dilated, Respondent instructed her to push. Respondent again checked the fetal heart rate and found that it had decelerated to 60. That the patient had a history of having rapid deliveries and was a multipara (had previously had one or more viable births) was significant in that it was very likely that with good expulsive efforts the baby would be delivered in a short time. Respondent was concerned when she got the decelerated fetal heart rate but believed birth to be imminent. An experienced birth practitioner can judge whether delivery will be expeditious. At 11:58 p.m. the baby was at the +2 station (half the way down the birth canal, i.e., half way out). The fetal heart rate was 60 when Respondent again checked. Respondent's extensive training and experience had made her aware that it was not unusual to encounter a decelerated fetal heart rate directly prior to birth. A deceleration of the fetal heart rate at the final stage of labor can result from "head molding," and the rotation of the baby. In other words, it is very common to have a fetal heart rate drop due to head compression and the transverse lie of the head during the final stages of delivery. In 98% of those cases, the decelerated fetal heart rate will return to base line. In Respondent's previous experience, babies who had similar deceleration in their heart rate came out vigorous and robust, or may have needed a little tactile stimulation or warmth to be resuscitated, but always came out normal. Her training dictated that the proper procedure was to assess whether delivery was imminent. Respondent knew that a heart rate of 60 sustained for a few moments with no progress would be considered an emergency situation necessitating physician consultation or contacting emergency medical services for transportation to a hospital. On the other hand, a fetal heart rate of 60 sustained for a few moments with progress was not unusual, and the best course of action was to facilitate delivery of the baby. Since her patient was having strong contractions, was making good expulsive efforts, and the baby was descending rapidly down the birth canal, Respondent knew that birth was imminent. Exactly twelve minutes after the patient came out of the shower, the baby was delivered. The baby was stillborn. Respondent had no indication prior to the delivery of the baby that the baby would be severely compromised or dead. Respondent is fully trained in resuscitation of babies. She is certified in medical CPR, has taken many continuing education courses in emergency procedures, and is certified in and carries with her the equipment necessary for neonatal resuscitation: neosuctioning, an Ambu Bag, and oxygen. When the baby was delivered at 12:02 a.m., Respondent caused one of the adults present to contact fire rescue. Respondent immediately began resuscitation efforts and continuously attempted to resuscitate the baby until the fire rescue unit arrived, which was fifteen minutes after fire rescue was called the first time. Between the first decelerated fetal heart rate and delivery of the baby twelve minutes later, Respondent did not refer the patient to a physician or consult with Dr. Eagleman because to do so would have taken time away from managing a potentially dangerous situation and because she knew that Dr. Eagleman would merely tell her to get the baby delivered. Further, Respondent did not consider the drop in the heart tones to be abnormal requiring her to refer the patient to a physician since there was rapid progress and birth was imminent. Dr. Eagleman verified during the final hearing in this cause that had Respondent contacted him during the twelve minutes in question to report the decelerated heart rate, he would have told her to get off the telephone, go back to her patient, and "get the baby out." Respondent had never previously delivered a stillborn. There is no suggestion made in this record either that Respondent should have known that the baby would be stillborn or that Respondent contributed in any way to cause that unfortunate outcome. Respondent contacted Anne Richter to advise her what had happened and subsequently sent written reports to Richter detailing her care of patient Freireich. Petitioner has never before taken disciplinary action against Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered Finding Respondent guilty of violating Rule 10D-36.042(1), Florida Administrative Code (1989); Finding Respondent not guilty of violating Rule 10D-36.46(4)(e), Florida Administrative Code (1989); Finding that no disciplinary action should be imposed because the violation was neither willful nor repeated; and Dismissing the Notice of Formal Reprimand filed in this cause. DONE and ENTERED this 31 day of March, 1992, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 SC 278-9675 Filed with the Clerk of the Division of Administrative Hearings this day of March, 1992. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 91-1953 Petitioner's proposed findings of fact numbered 1, 2, 7, 8, 15 and 16 are adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 3-6, and 9-14 are rejected as not being supported by the weight of the competent evidence in this cause. Respondent's proposed findings of fact numbered 1-9, 12, 13, 15, 19-33, and 35-39 are adopted either verbatim or in substance in this Recommended Order. Respondent's proposed finding of fact numbered 10 is rejected as not being supported by the weight of the competent evidence in this cause. Respondent's proposed finding of fact numbered 18 is rejected as being subordinate to the issues herein. Respondent's proposed findings of fact numbered 11, 14, 16, 17, 34, and 40 are rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. COPIES FURNISHED: Karen Miller, Esquire District IX Legal Counsel Department of Health and Rehabilitative Services 111 Georgia Avenue West Palm Beach, Florida 33401 Thomas G. Sherman, Esquire 218 Almeria Avenue Coral Gables, Florida 33134 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue The issues in this case are whether Respondent violated Section 458.331(1), Florida Statutes (1995) 1/ by failing to practice medicine according to the applicable standard of care, by performing unnecessary and improper breast examinations on eight patients, by failing to document the examinations in his medical records, and by documenting tests that were not performed, and, if so, what, if any, penalty should be imposed pursuant to Florida Administrative Rule 59R-8.001. 2/
Findings Of Fact 1. Petitioner is the state agency responsible for regulating the practice of medicine. Respondent is licensed to practice medicine pursuant to license number ME0062132. Education, Experience, And Reputation Respondent practiced neurology in Jacksonville and St. Augustine, Florida, until Petitioner issued an emergency suspension of his license in December, 1995. Respondent is not a board certified neurologist. Respondent was graduated from medical school in India, where he was born, and received some post-graduate medical training there. The post-graduate training included a six-month "house post" in obstetrics and gynecology ("OB/GYN"). A "house post" is the equivalent of a residency in the United States. In 1983, Respondent moved to the United States and passed all required examinations. From 1985 through 1987, he completed an 18-month residency in the Department of Neurology, University of Minnesota, Veteran's Administration hospital. In 1988, Respondent completed a rotating internship at the University of Minnesota and a three-year residency in neurology in 1991. In June, 1992, he completed a one-year fellowship in physio-neurology. Respondent moved to Florida and was employed at the Jacksonville Neurological Clinic. In 1994, Respondent established his own neurology practice in St. Augustine under the name of the St. Augustine Neurological Clinic (the "Clinic"). From 1985 through April 8, 1994, Respondent had an exemplary professional career, without incident, in multiple jurisdictions. He has a reputation in the professional community for competency and veracity. Medical Records Respondent examined and treated the eight patients involved in this proceeding in his Clinic. The eight patients are D.R., L.W., L.Y., L.B., C.L., D.S., L.T., and D.P. Respondent performed 16 breast examinations on these patients. Respondent performed one breast examination on D.R., L.W., L.Y., and C.L.. He performed two breast examinations on D.S. and L.T., five breast examinations on L.B., and three breast examinations on D.P. Respondent documented the breast examinations on D.S. in his medical records and one of the breast examinations on D.P. Respondent failed to document the other breast examinations in his medical records. Breast Examinations: Necessity and Propriety Petitioner charged Respondent with performing breast examinations that were unnecessary and inappropriate. The preliminary factual issue for each patient is whether a breast examination was medically necessary. The secondary issue is whether the breast examination actually given was performed in an appropriate manner and for appropriate purposes. The issue of whether Respondent documented medical tests that he did not actually perform is discussed in the context of each patient. Neurology involves the diagnosis and treatment of diseases of the brain, spinal cord, nerves, and muscles. Neurologists generally obtain patients by referral from other primary care physicians including family physicians and OB/GYNs. Neurologists can approach similar neurological problems differently, including different initial examinations for new patients. Some neurologists give a new patient a general physical examination as well as a neurological examination. General examinations may include a breast examination. A breast examination by a neurologist is medically necessary in some instances. A definite connection exists between breast cancer and some neurological problems. Breast cancer can metastasize into the brain and cause a brain tumor and headaches. Breast cancer can metastasize to the lung and cause other problems. There are a variety of symptoms patients may experience when breast cancer spreads to other parts of the body depending on whether the disease spreads to the brain, the spinal cord, the skull, or the blood stream. If a neurologist has training in other medical specialties, it is appropriate for the neurologist to use that training in diagnosing and treating neurological patients. Respondent has training in breast examinations from medical school, his "house post," and his rotating internship. Respondent has performed hundreds of breast examinations over the past 15 years. He routinely performs breast examinations on approximately one-third of his patients. A breast examination that is performed appropriately has no negative side effects. Some neurologists perform breast examinations and some do not. D.R. is a 49-year-old female. On June 7, 1995, Dr. Ernest Carames, D.R.'s primary care physician, hospitalized D.R. in Flagler Hospital for chest pains. Dr. Carames requested Respondent to evaluate D.R. for possible seizures and multiple sclerosis. Respondent performed a neurological examination of D.R. in the hospital on June 7, 1997. As part of the examination, Respondent ordered a magnetic resonance imaging scan (an "MRI") which was performed on June 8, 1995. Respondent scheduled D.R. for follow up in his office on June 21, 1995. At the follow up on June 21, 1995, Respondent took D.R. to his office and reviewed her condition with her. After a few minutes in the office, Respondent took D.R. to an examining room and performed a breast examination. The breast examination was not medically necessary. Dr. Carames was D.R.'s primary care physician and was treating D.R. for chest pain. Objective findings available to Respondent prior to the breast examination were insufficient to establish a medical necessity for, or to otherwise justify, a breast examination by Respondent. Respondent had previously ruled out multiple sclerosis and seizures. Respondent's medical records were insufficient to establish a medical necessity for, or to otherwise justify, a breast examination by Respondent. Respondent performed the breast examination inappropriately. Respondent instructed D.R. to sit on the examination table without an examination gown. Respondent and D.R. were alone in the examination room. Respondent lifted D.R.'s brassier ("bra") over her breasts. Respondent cupped D.R.'s left breast, then her right breast, and back to the left breast. He alternated between D.R.'s two breasts for several minutes. Respondent put his hands around each breast. He twisted and pinched the nipple of each breast. D.R. informed Respondent that she had a rash under her breasts and that his examination was painful. She explained that the skin affected by the rash would split and bleed if Respondent lifted her breasts too much. Respondent ignored D.R.'s complaints and explanation. When D.R.'s skin bled, Respondent terminated the examination. Respondent met D.R. in his office. He informed her that the MRI results were negative and that he had ruled out multiple sclerosis and seizures. Respondent never informed D.R. of the medical necessity for the breast examination. D.R. had never received a breast examination that was performed in the manner performed by Respondent. Respondent documented tests for D.R. in his medical records that he did not perform. Respondent's medical records for D.R. indicate that Respondent performed: a general physical examination, including a blood pressure and pulse; a head and neck examination; a chest examination; a motor examination; a test of deep tendon reflexes; a sensory examination; and an examination of the patient's station, gait, and coordination. Except for the last examination listed in the preceding paragraph, Respondent did not perform the examinations documented in his medical records. The evidence was less than clear and convincing that Respondent did not examine D.R.'s station, gait, and coordination by observing her in the examination room and from his office to the examination room. L.W. is a 37-year-old female. On June 27, 1995, L.W. presented to Respondent with complaints of arm pain. Respondent took L.W. to his office and reviewed her condition. After a few minutes in the office, Respondent took L.W. to an examining room and performed a breast examination. The breast examination was not medically necessary. L.W. presented with arm pain seeking a neurological examination. Neither the objective findings available to Respondent prior to the breast examination nor Respondent's medical records were sufficient to establish a medical necessity for, or to otherwise justify, a breast examination by Respondent. Respondent did not inform L.W. of a medical necessity for a breast examination. Respondent performed the breast examination inappropriately. Respondent instructed L.W. to remove her top and lie down on the examination table without an examination gown. Respondent and L.W. were alone in the examination room. Respondent placed the palms of his hands on L.W.'s breasts and rubbed her breasts in a circular motion. He then unsnapped L.W.'s shorts and unzipped them. He asked L.W. if she was married. Respondent put his hands just above L.W.'s pubic region. He pressed and rubbed the area. L.W. asked Respondent why he was examining her pubic area for arm pain. Respondent did not provide an explanation. Respondent terminated the examination. Respondent never examined L.W.'s arm and performed no other examinations. Respondent documented tests for L.W. in his medical records that he did not perform. Respondent's medical records for L.W. indicate that Respondent performed a comprehensive medical examination. A comprehensive medical examination requires: an extensive history of the presenting complaints; a review of the patient's medical, family, and social history; a review of her current medications and allergies; a review of at least 10 endocrine systems; and complete neurological and physical examination. Respondent did not perform a comprehensive medical examination of L.W. L.B. is a 37-year-old female. On January 20, February 22, March 22, March 30, and April 6, 1995, L.B. presented to Respondent with complaints of trauma-induced headaches from an automobile accident. Respondent performed five breast examinations on L.B. in approximately 76 days. None of the breast examinations were medically necessary. L.B. presented with headaches caused by trauma. Neither the objective findings available to Respondent prior to each of the breast examinations nor Respondent's medical records were sufficient to establish a medical necessity for, or to otherwise justify, a breast examination by Respondent. Respondent did not inform L.B. of a medical necessity for any of the breast examinations. Respondent performed each of the breast examinations inappropriately. On each occasion Respondent and L.B. were alone in the examination room and L.B. had no examination gown. On January 20, 1995, Respondent reviewed L.B.'s condition with her in his office. He then took L.B. to an examining room and performed the first breast examination. Respondent instructed L.B. to remove her clothes from the waist up and to sit on the examination table. Respondent and L.B. were alone in the examination room. Respondent placed one hand on each of L.B.'s breasts. He squeezed each breast and nipple. He then cupped each breast and used both of his hands to rub each breast individually. Respondent did not provide an explanation of the medical necessity for the breast examination. He instructed L.B. to return to his office in one month. On February 22, 1995, L.B. returned to the Clinic in accordance with Respondent's medical advice. Respondent ushered L.B. directly to the examination room, locked the door, and performed the second breast examination. Respondent instructed L.B. to remove her clothes from the waist up and to sit on the examination table. He placed both hands on one of L.B.'s breasts and squeezed and massaged it. He squeezed and pulled the nipple. He then repeated the process on the other breast. He instructed L.B. to return to his office on March 22, 1995. On March 22, 30, and April 6, 1995, Respondent took L.B. directly to the examination room, locked the door, and performed the remaining three breast examinations. He performed each of the last three breast examinations using the same techniques as he used on January 20 and February 22, 1995. Respondent documented tests for L.B. in his medical records that he did not perform. Respondent's medical records for L.B. indicate that Respondent performed a Babinski test and an examination of: the head and neck, including the ear, nose, and throat; the abdomen; the spinal area; and all eleven cranial nerves. Respondent did not perform these tests. C.L. is a 31-year-old female. On December 23, 1994, C.L. presented to Respondent with numbness in her arm. Respondent took C.L. to his office and reviewed her condition. After a few minutes in the office, Respondent took C.L. to an examining room and performed a breast examination. The breast examination was not medically necessary. C.L. presented with numbness in her arm and sought a neurological examination for the condition. On December 22, 1994, C.L.'s gynecologist had given C.L. a complete physical that included a breast examination. Neither the objective findings available to Respondent prior to the breast examination nor Respondent's medical records were sufficient to establish a medical necessity for, or to otherwise justify, a breast examination. Respondent did not inform C.L. of the medical necessity for a breast examination. Respondent performed the breast examination inappropriately. Respondent instructed C.L. to remove all of her clothes from the waist up and to lie down on the examination table without an examination gown. Respondent and C.L. were alone in the examination room. C.L. objected to the examination and Respondent's instructions. C.L. explained that her gynecologist had performed a breast examination the previous day. Respondent insisted and C.L. reluctantly complied. Respondent cupped each breast with the palm of his hand. He pinched each nipple and rubbed his hands from her neck to the edge of her nipples. Respondent instructed C.L. to return to the Clinic for another office visit. C.L. never returned. Respondent documented tests for C.L. in his medical records that he did not perform. Respondent's medical records for C.L. indicate that Respondent examined C.L.'s eye with a swab or other instrument, examined her gait, and performed a Babinski test. Respondent did not perform these tests. L.Y. is a 37-year-old female. On May 25, 1995, L.Y. presented to Respondent with complaints of migraine headaches. Respondent took L.Y. to his office and reviewed her condition. After a few minutes in the office, Respondent took L.Y. to an examining room and performed a breast examination. The breast examination was not medically necessary. L.Y. presented with migraine headaches and sought a neurological examination for the condition. Neither the objective findings available to Respondent prior to the breast examination nor Respondent's medical records were sufficient to establish a medical necessity, or to otherwise justify, a breast examination. Respondent did not inform L.Y. of the medical necessity for a breast examination. Respondent performed the breast examination inappropriately. Respondent instructed L.Y. to remove all of her clothes from the waist up. L.Y. did so and put on an examination gown that she had requested. Respondent, L.Y., and L.Y.'s five year-old son were the only individuals in the examination room. Respondent rubbed each breast with the palm of his hand. The palm of each hand made contact with each nipple. The breast examination was unlike any breast examination L.Y. had previously received. D.S. is a 27-year-old female. On November 28, 1994, D.S. presented to Respondent with complaints of migraine headaches. D.S. was referred to Respondent by her gynecologist who had recently performed a yearly physical that included a breast examination. D.S. had a calcified cyst in her right breast. The cyst had been present for five years and was monitored routinely by her gynecologist. D.S. was scheduled for a routine mammogram shortly after her neurological examination. Respondent performed two breast examinations on D.S. on the same day. He performed one breast examination in the examination room and the second in his office. Neither of the breast examinations were medically necessary. D.S. had recently received a breast examination during from her gynecologist during her annual physical and was scheduled for a mammogram. She presented to Respondent with migraine headaches and sought a neurological examination. Neither the objective findings available to Respondent before the breast examinations nor Respondent's medical records were sufficient to establish a medical necessity for, or to otherwise justify, a breast examination by Respondent. Respondent did not inform D.S. of the medical necessity for a breast examination. Respondent performed both breast examinations inappropriately. After D.S. completed some forms in the reception area, Respondent took D.S. directly to an examination room and performed the first breast examination. Respondent instructed D.S. to remove her clothes from the waist up. He gave her an examination gown and left the room. D.S. removed all of her clothes from the waist up except her bra. She put on the examination gown. Respondent returned to the examination room and performed the breast examination. Respondent and D.S. were alone in the examination room. Respondent lifted D.S.'s bra. He felt her left breast and then her right breast. He then felt both breasts simultaneously. He then felt each breast separately again. During the examination, D.S. objected to the examination. She explained that her gynecologist had just performed a breast examination and that she was scheduled for a mammogram to monitor the cyst in her right breast. Respondent continued the examination. He continued to touch both breasts simultaneously with both hands. He repeatedly twisted both nipples simultaneously with both hands. Respondent completed the examination. He instructed D.S. to get dressed and to meet him in his office. In his office, Respondent discussed more tests and asked D.S. more questions about her condition. Respondent then rose from his chair, locked the door to his office, and told D.S. that he wanted to check the cyst in her right breast. Respondent instructed D.S. to unbutton her blouse. Respondent pulled up D.S.'s bra and asked her to stand and lean forward. Respondent squeezed and twisted both of D.S.'s nipples. He touched both breasts simultaneously. Respondent did not touch the area of the cyst. Respondent instructed D.S. to return to his office for follow up. D.S. never returned. Respondent documented tests for D.S. in his medical records that he did not perform. Respondent's medical records for D.S. indicate that Respondent performed a head and neck examination, an examination of 11 pairs of cranial nerves, a motor examination, and a sensory examination. Respondent did not perform these tests. L.T. is a 29-year-old female. On July 10, 1995, L.T. presented to Respondent with complaints of headaches and seizures. L.T. was referred to Respondent by her kidney specialist. L.T. also had a gynecologist who had performed a complete physical within one year of L.T.'s visit to Respondent. The complete physical included a breast examination. Respondent performed a breast examination on L.T. on July 10, 1995, and August 4, 1995. Neither of the breast examinations were medically necessary. L.T. recently had a breast examination from her gynecologist during her annual physical. She presented to Respondent with headaches and seizures. Neither the objective findings available to Respondent prior to the breast examinations nor Respondent's medical records were sufficient to establish a medical necessity for, or to otherwise justify, a breast examination by Respondent. Respondent did not inform L.T. of the medical necessity for a breast examination. Respondent performed both breast examinations inappropriately. On both occasions, Respondent and L.T. were alone in the examination room, and L.T. had no examination gown. On July 10, 1995, L.T. completed some forms in the reception area and Respondent took L.T. to his office where he asked her some routine questions. Respondent then took L.T. to an examination room and performed the first breast examination. Respondent instructed L.T. to sit on the examination table. He took her blood pressure and had her to lie on her back. Respondent listened to L.T.'s heart for a moment. He then pulled her shirt and bra over her breasts and squeezed both of her breasts simultaneously. Respondent told L.T. to place her hands behind her head. Respondent squeezed one breast and then the other. He then repeated the same process several times alternating between breasts. He then twisted and rolled L.T.'s nipples simultaneously with his fingers while the palms of hands grasped her breasts. Respondent moved his hands toward L.T.'s abdomen and applied pressure. He then moved his hands down to the hairline of the pubic region to examine a scar. Respondent moved his hands back up to L.T.'s breasts. He squeezed both breasts simultaneously while rolling both nipples with his fingers. During the examination, Respondent asked L.T. about her nationality. L.T. questioned the question. Respondent explained that L.T. had no tan lines. Respondent completed the examination. He instructed L.T. to get dressed and accompany him to his office. In his office, Respondent prescribed an MRI and electroencephalogram ("EEG"). The MRI was performed on July 18, 1995, and produced no positive findings. The EEG was performed in the Clinic by Respondent's nurse. The nurse scheduled L.T. to return to Respondent's office on August 4, 1995, to obtain the results of the EEG. The EEG produced no positive findings. On August 4, 1995, Respondent took L.T. to his office. Respondent stated that he found something abnormal but did not disclose the nature of the abnormality. He took L.T. to the examination room. In the examination room, Respondent had L.T. sit on the examination table and then lie down on the table with her hands behind her head. He pulled up her shirt and bra over her breasts. He then listened to her heart while he held her left breast in his right hand. He then touched both breasts with both hands while twisting her nipples with his fingers. Respondent instructed L.T. to return to his office for another EEG. L.T. returned on the next day. However, she did not stay for the test and never saw Respondent again. Respondent documented tests for L.T. in his medical records that he did not perform. The medical records for L.T. indicate that Respondent performed a cranial nerve test and deep tendon reflex test. Respondent did not perform either test. D.P. is a 39 year-old female. On April 8, 1994, D.P. presented to Respondent with complaints of migraine headaches. Respondent performed a breast examination on D.P. on July 10, 1995, in November 1994, and in the Spring of 1995. None of the breast examinations were medically necessary. D.P. presented to Respondent with migraine headaches and sought a neurological examination. Neither the objective findings available to Respondent prior to each breast examination nor Respondent's medical records were sufficient to establish a medical necessity for, or to otherwise justify, a breast examination by Respondent. Respondent did not inform D.P. of the medical necessity for a breast examination. Respondent performed all three breast examinations inappropriately. On each occasion, Respondent and D.P. were alone in the examination room, and D.P. had no examination gown. On April 8, 1994, D.P. completed some forms in the reception area, and Respondent took D.P. to his office where he asked her some routine questions. Respondent then took D.P. to an examination room and performed the first breast examination. Respondent instructed D.P. to remove her clothes from the waist up and to lie down on the examination table. He massaged both of her breasts with his hands. He then had her sit up on the table and again massaged both breasts. He lifted both breasts with his hands and continued to massage both breasts while he pinched her nipples with his fingers. During the examination, Respondent stated repeatedly that he had to be thorough. The repeated statements were disconcerting to D.P. The breast examination was like no other breast examination D.P. had received. It was lengthy and irregular. Respondent completed the examination. He instructed D.P. to get dressed and to meet him in his office. In his office, Respondent recommended that D.P. return on a monthly basis. Respondent advised that he could not refill her prescription unless he examined her monthly. D.P. returned to the Clinic over the next several months without incident. In November 1994, Respondent took D.P. to the examination room. He instructed D.P. to remove her clothes from the waist up. Respondent grasped both breasts and massaged them in a clinching manner. He pinched and twisted both nipples. In the Spring of 1995, Respondent took D.P. to an examination room and performed another examination that Respondent described to D.P as a breast examination. Respondent put both of his hands down D.P.'s bra and placed a stethoscope on one of her nipples. On her last visit, Respondent fingered D.P.'s bra strap. He told her it was very nice. The examination terminated shortly thereafter. Respondent performed all 16 breast examinations on the eight complaining witnesses in this proceeding for purposes of engaging them in sexual activity within the meaning of Section 458.329. In each case, Respondent exercised his influence within the patient-physician relationship for purposes prohibited by Section 458.329.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order and therein: find Respondent guilty of violating Sections 458.311(1)(j), (k), (m), (t), and (x); impose an administrative fine of $105,000; suspend Respondent's license for three years, including the period of suspension prior to a final order in this case; place Respondent on probation for three years; require Respondent to complete a reasonable amount of continuing professional education; and restrict Respondent's practice in accordance with the provisions of this Recommended Order. DONE AND ENTERED this 6th day of August, 1997, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 6th day of August, 1997.
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2010.
