The Issue The central issue in this case is whether the Respondent committed the violations alleged in the administrative complaint; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent holds an active license to practice medicine, license number ME 0030238 (Physician). Respondent's practice is limited to what he has described as "cosmetic" surgery, but which is considered plastic or reconstructive surgery. Typically, Respondent performs elective surgery for cosmetic purposes to breasts, abdomen, buttocks, face (eyes, lips, cheeks), or hips. In August, 1990, the patient, V.A., presented to the Respondent for a pre-operative consultation and examination. At the time, V.A. was interested in having liposuction, breast enlargement, and an abdominoplasty. Due to her medical history, V.A. was an extremely poor candidate for an abdominoplasty. The pre-operative history and physical examination performed by Respondent as reflected in the records maintained by Respondent for the patient, V.A., were inadequate. No records supporting a complete physical examination and history have been provided. The pre-operative medical records maintained for the patient, V.A., do not support the course of treatment proposed for the procedures to be performed. Respondent did not order a pre-operative lab work-up for the patient, V.A. Such lab order would normally consist of a complete blood count, a urinalysis, electrolytes, blood sugar, blood nitrogen test, and a mammogram or breast examination since the breasts were to be augmented. Respondent relied on lab test results for V.A. which were approximately three months old. Respondent believes that the reliance on tests up to six months old would be acceptable since he only performs surgery on healthy patients. Respondent performed no independent examination of V.A. to verify she was "healthy," prior to surgery. Failing to obtain current lab tests of the types described above before performing elective surgery of the nature sought by V.A. constitutes the practice of medicine below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. On or about August 30, 1990, Respondent performed the following procedures on V.A.: liposuction; breast enlargement; and an abdominoplasty. In order to perform the procedures noted, Respondent used general anesthesia so that V.A. was under anesthesia for six hours. During that time, Respondent opened V.A.'s abdomen, removed tissue, removed adipose tissue from various parts of the patient's body, injected fat tissue into the patient's breasts, cheeks and hands, and closed the abdominal wound with stitches. The surgical or operative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe the procedures performed. The Respondent was released to go home approximately two hours after the surgery. The postoperative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe how the patient was able to be discharged in so short a time after surgery. V.A. returned to Respondent's office numerous times following the surgery. V.A. sustained an infection and complications from the wound to her abdomen that took months to heal. Respondent treated the infection by scraping the wound and attempting to re-stitch it on at least two occasions. V.A. sustained necrosis which is the death of tissue and which complicated the healing of the abdomen wound. The loss of skin from necrosis is much more likely to occur when the patient has scarring. Given V.A.'s medical history (scarring throughout the areas), the necrosis was almost inevitable. Two procedures are available under the circumstances applicable to V.A.: allowing the wound to heal without stitches or to use a skin graft. The procedure used by Respondent (stitching the infected area) fell below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. Injecting fat tissue for breast augmentation is inappropriate. Since it is common for the fat tissue to die after injection, the injected tissue then appears on a mammograph as a mass of suspicious origin. That is, it is difficult to differentiate from a breast mass that is a medical problem from that of the dead fat tissue. As a result, biopsies may be required to verify the mass content. In fact, V.A. has already had to have such a procedure following the augmentation performed by Respondent. Respondent also conducted a pre-operative interview with a patient, P.T. P.T. was a radio talk show host at the time and suggested that the station, she and Respondent could all benefit from a campaign wherein she would have liposuction, the Respondent would receive her endorsement through advertising, and the station would have advertising paid for by the Respondent's clinic. In an attempt to negotiate the terms of the advertising campaign, P.T., an advertising executive with the radio station, Respondent's office manager, and Respondent met together to discuss the project. Respondent wanted a multifaceted campaign requiring P.T. to undergo more than just the liposuction she sought. Respondent's scope for the campaign included many of the surgeries his clinic offered. While discussions continued for the advertising campaign terms, P.T. underwent pre-operative testing which included a blood test, medical history forms, and photographs. During an office consultation in anticipation of surgery, Respondent requested that P.T. allow him to examine her. Unlike a previous examination which had occurred without incident with someone in the room, Respondent closed and locked his office door and requested that P.T., who was alone with Respondent, stand near his desk. When she complied, he leaned forward and raised her dress over her breasts. Next he unhooked her bra and pulled it over her breasts. Respondent proceeded to poke and prod P.T. across her breasts and abdomen during which time P.T. presumed it was for medical purposes. P.T. became uncomfortable when the prodding which continued became more like a caress. She attempted to presume Respondent was merely checking the texture of her skin but became increasingly uncomfortable with his touch. P.T.'s discomfort accelerated when she realized Respondent had placed his face in her vaginal area and was licking her. She immediately attempted to pull away. Respondent grabbed her on the breast and, as P.T. put it, "in the crotch." P.T. struggled with Respondent who made several sexually inappropriate comments to her. As P.T. attempted to regain her composure and close her clothes, the Respondent's office manager knocked on the door. On hearing the office manager, Respondent released P.T. and went to unlock the door. At the time of the foregoing incident, P.T. was the Respondent's patient. Respondent did not maintain appropriate medical records for the course of treatment proposed for the patient, P.T. Respondent's course of conduct with the patient, P.T., fell below the standard of care a reasonably prudent physician would pursue for treatment of this patient. Respondent attempted to engage a patient in a sexual activity. P.T. did not consent to the activity described above.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Agency for Health Care Administration, Board of Medicine enter a final order finding the Respondent guilty of violating Sections 458.331(1)(j), (m), and (t), Florida Statutes, and imposing the following penalties in accordance with the guidelines set forth by rule: revocation of the license together with an administrative fine in the amount of $15,000.00. DONE AND ORDERED this 16th day of August, 1995, in Tallahassee, Leon County, Florida. JOYOUS D. PARRISH 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 16th day of August, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3609 Rulings on the proposed findings of fact submitted by the Petitioner: 1. Paragraphs 1 through 56 are accepted as accurate as to the facts but not necessarily the form for findings of fact. Typically, findings of fact should not recite testimony. Rulings on the proposed findings of fact submitted by the Respondent: 1. None submitted. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Kenneth J. Metzger Senior Attorney Agency for Health Care Administration/Board of Medicine 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Leon Doyan, M.D. 2817 E. Oakland Park Boulevard Fort Lauderdale, Florida 33306
Findings Of Fact Based upon all of the evidence, including the pleadings and stipulated record, the following findings of fact are determined: On November 7, 1989, the Department of Professional Regulation (DPR) received a copy of a Serious Incident Report (SIR) prepared by Alachua General Hospital in Gainesville, Florida. The SIR was filed pursuant to law and indicated that a newborn infant baby had died at the hospital on September 16, 1989, while under the care of petitioner, Thomas B. B. Benton, a licensed medical doctor and pediatrician. After the SIR was received, a DPR investigator conducted an investigation of the incident, including interviews with petitioner, six involved nurses, the obstretrician at delivery, and the pediatrician who responded to the emergency code at the hospital. The investigator also obtained the medical records of the mother and baby. On February 22, 1990, a one hundred seventeen page investigative report, consisting of the investigator's notes, medical records, SIR, and other related information, was issued. A copy of the investigative report was given to a board certified pediatrician on August 24, 1990, who reviewed the report and records with a focus on petitioner's care and treatment of his patient. The consulting physician was asked to answer nine specific questions, including whether petitioner prepared and kept written medical records justifying the course of treatment of the patient and whether petitioner met the applicable standard of care in his examination, diagnosis and treatment of the patient. Also asked were questions pertaining to whether petitioner had adquately assessed the patient's condition, whether it was inappropriate to place the patient in the regular nursery without a monitor, and whether it was inappropriate for petitioner to not inform the on-call doctor of the patient's condition. In response to this charge, the consultant prepared a twelve page analysis of the case with responses to each of the nine questions. The analysis contained an ultimate conclusion that petitioner had failed to meet the applicable standard of care with regard to his diagnosis and treatment of the baby and, with respect to the adequacy of his records, petitioner had failed to document his medical records with a definitive treatment plan and with reasons for not ordering certain tests on the infant. The investigative report and consultant's analysis were given to a probable cause panel on January 28, 1991. The panel was composed of two doctors and a lay person, all members of respondent, Board of Medicine (Board). After a discussion of the report and analysis, which the record shows was a meaningful inquiry, the panel found, by a 2-1 vote, probable cause that a violation of Subsections 458.331(1)(m) and (t), Florida Statutes, had occurred. Those subsections impose requirements that a physician keep adequate written medical records and adhere to the appropriate standard of care. The panel also recommended that DPR issue an administrative complaint. It is noted that the two panel members voting in favor of prosecution expressly relied on the consultant's report. On February 6, 1991, a two-count administrative complaint was issued by DPR alleging that petitioner had violated subsections 458.331(1)(m) and (t) in several respects. As to subsection 458.331(1)(m), the complaint alleged he had failed to document his reasons for not ordering a cardiac/apnea monitor, had failed to document his reasons for not ordering studies to assess the patient for the possibility of sepsis, and had failed to document a definitive plan of treatment. As to subsection 458.331(1)(t), it need only be said that the complaint alleged generally that petitioner failed to adhere to the standard of care while treating the infant. After petitioner requested a formal hearing to contest the charges, the complaint was forwarded to the Division of Administrative Hearings and was assigned Case No. 91-2367. Several months prior to hearing, DPR amended its first count in the complaint to delete the two allegations that respondent failed to document reasons for not ordering certain tests. In lieu thereof, it added an allegation that there was a contradiction between petitioner's recorded plans to closely monitor the infant and his subsequent conduct, an allegation also based on an alleged violation of subsection 458.331(1)(m). This amendment was made after petitioner had filed a motion to compel discovery seeking the basis for the two factual allegations and whether they contravened the holding in Breesmen v. Department of Professional Regulation, 567 So.2d 469 (Fla. 1st DCA 1990). Conceding as much that they did, the Board thereafter filed an amended complaint. Because the Board was a party to that case, and the issuance of the opinion predated the panel's meeting, it must be assumed that the panel and its counsel were aware, or should have been aware, of the case's holding when the matter was considered. Therefore, the Board's decision to bring the two deleted charges in Count I was not substantially justified. After an evidentiary hearing was conducted, a recommended order was issued on November 7, 1991, recommending that the complaint be dismissed with prejudice. This recommendation was adopted in toto by the Board and a final order dismissing the complaint was issued on February 25, 1992. The recommended and final orders are reported in Department of Professional Regulation v. Benton, 14 F.A.L.R. 1924 (Board of Medicine, February 22, 1992). Because no appeal was taken, the Board's order is now final. Petitioner contends that the consultant's analysis is at odds with the information available to the probable cause panel and thus the panel's reliance on the analysis resulted in a flawed decision to prosecute. More specifically, petitioner focused on that part of the analysis which concluded that he failed to perform certain follow-up tests on the patient, failed to place the patient on a monitor or under closer supervision in the nursery, and failed to inform the on-call physician about the patient's medical problems. All relate to the general charge in Count II that he failed to conform to the appropriate standard of care. To support her conclusion that petitioner failed to perform certain follow-up tests, the consultant noted that at the time of birth, the patient's mother had had a fever for several days and the infant was at risk for sepsis (infection), the infant had known neurologic abnormalities, the mother had experienced placental abruption and thus the child may have had anemia, and the child was at risk for respiratory problems from possible meconium aspiration. Although the medical records showed that the mother's fever had actually subsided before the C-section was performed, the mother had experienced fever for several days just prior to the date of delivery and was on antibiotics. The records also reflected that the child had neurologic abnormalities, meconium staining was present at birth, and the mother had a partial placental abruption during delivery. Therefore, the consultant's analysis as to this allegation was substantially in accord with the medical records, and the panel had a reasonable basis in fact to bring this charge. The complaint also alleged that petitioner failed to adequately monitor the baby after it was placed in the nursery. This allegation was drawn from a recommendation by the consultant, whose conclusions were based on two considerations. First, the infant had known neurologic abnormalities and other risk factors, as discussed in the previous finding. Second, the consultant opined that the regular nursery was a "busy nursery", the nurses did not have "many years of nursing experience", and "all worked (in the newborn nursery) less than one year". The latter opinion was predicated on certain investigative notes and the consultant's review of statements made by six nurses. Petitioner asserts that because the investigator failed to record the work experience of a senior nurse and failed to interview two nurses who were on duty in the nursery the night of the infant's death, and the consultant failed to note that several of the nurses had been licensed for more than two years, the recommendation was flawed. However, it is noted that the consultant did not rely exclusively on the purported lack of experience on the part of the nursing staff in reaching her conclusion but placed equal reliance on the notion that the baby's history and risks warranted giving the baby special post-delivery supervision. Therefore, the report contains a factual basis to support the consultant's conclusion and thus the panel had a reasonable basis in fact to bring this charge. Petitioner next contends that the recommendation to charge him with failing to adhere to the standard of care because of his failure to inform the on-call physician about the patient's condition and history was likewise at odds with the real facts. In making this argument, he points to findings in the recommended order which found in favor of petitioner on this issue and to that portion of the baby's medical records which recorded his condition while in the nursery. Again, however, the consultant reached this conclusion based on the baby's "history and status", and thus she had a factual basis to support her opinion. Therefore, the panel's decision to prosecute this alleged breach of care was substantially justified. The parties have stipulated that petitioner is a small business party as defined by Subsection 57.111(3)(d), Florida Statutes, he was the prevailing party in the underlying disciplinary action, his attorney's fees and costs incurred in defending against the action are reasonable but are limited to the statutory cap of $15,000, and at least $4,000 was incurred in defending Count I while at least $15,000 was incurred in defending Count II. They have further agreed that there are no special circumstances that would make an award of attorney's fees and costs unjust.
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.
The Issue The issues in this case are whether the allegations of the Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact The Respondent is a licensed medical doctor, holding license number 44726. At all times material to this case, the Respondent was a physician holding board certifications in internal medicine, hematology, and oncology. Patient 1 was a patient of another hematologist, Dr. Thomas Katta. On March 17, 2003, Dr. Katta had Patient 1 admitted via the patient's internist (Dr. Frank Leiva) to Sand Lake Hospital in Orlando. The patient was anemic and thrombocytopenic and had been previously diagnosed with autoimmune hemolytic anemia, the treatment for which was transfusion. Failure to transfuse a person suffering from autoimmune hemolytic anemia can lead to death, and such a transfusion had been ordered for the patient. Dr. Katta apparently had personal obligations for the evening of March 17, 2003, and for the following day, and, in the late afternoon of March 17, 2003, he asked the Respondent to "cover" his hospitalized patients. The Respondent agreed to do so. Dr. Katta's office transmitted a list of the patients by fax to the Respondent's office. The list contained the full names and locations of Dr. Katta's other hospitalized patients, but identified Patient 1 only by last name and diagnosis ("AIHA"). The fax did not indicate the patient's first name or gender and did not specifically identify the patient's location. The Respondent made no attempt to obtain additional information from Dr. Katta or his staff. The lab work performed upon admission to the hospital indicated that the patient was severely anemic and had a critically low platelet count. At approximately 6:30 p.m. on March 17, 2003, the Respondent received a telephone call through her answering service from a hospital nurse who reported that the patient was severely anemic and that there were problems obtaining a proper blood match for the transfusion. The Respondent advised the nurse to call the blood bank and tell them to find the least incompatible blood and get the transfusion done. The Respondent did not inquire as to the patient's name or location. At about 10:19 p.m. on March 17, 2003, the Respondent was again contacted by a hospital nurse, who advised that the patient was short of breath and had tachycardia at 133 beats per minute. The nurse also advised that the blood bank had been unable to find an appropriate match for the previously ordered transfusion and that the transfusion remained uncompleted. The Respondent directed the nurse to contact the patient's primary care physician or the cardiologist on call, but did not ask the identity of either practitioner. The nursing notes indicate that the Respondent stated that she did not provide treatment for tachycardia and did not believe that Dr. Katta did either. The Respondent also advised the nurse to call the blood bank and direct them to find the least incompatible blood and perform the transfusion. The Respondent did not inquire as to the patient's name or location and provided no other direction to the reporting nurse. On the next day, March 18, 2003, at about 6:15 a.m., the Respondent was contacted by a hospital nurse, who advised that the transfusion had still not taken place. The Respondent took no action and provided no direction to the reporting nurse. The Respondent did not inquire as to the patient's name or location. Later during the morning of March 18, 2003, the Respondent attempted to locate the patient while making her rounds but was unsuccessful. In attempting to locate the patient, the Respondent talked with various hospital personnel, but had no information other than the patient's last name and diagnosis. Based on her inability to obtain any additional information, the Respondent assumed that the patient had been transfused and discharged. The patient had not been discharged, but had been transferred to an intensive care unit in the hospital. The transfusion had not yet occurred. Patient 1 died on March 20, 2003. The Respondent was unaware of the patient's death until she saw Dr. Katta at the hospital, at which time he questioned her about the patient and informed her that the patient was dead. The Petitioner presented the testimony of Dr. Howard Abel, M.D., regarding whether the Respondent met the standard of care in her treatment of the patient. Dr. Abel's testimony regarding the standard of care issues is credited and is accepted. As to the issue of the uncompleted transfusion, the evidence establishes that the transfusion did not occur while the Respondent provided hematological care for Patient 1. The Respondent should have personally contacted the blood bank to identify the cause of the inability to provide blood for the transfusion and determine whether another option was available. The Respondent should have responded to the 10:19 p.m. call on March 17 by personally examining the patient and reviewing the history and lab test results. While the Respondent's directive to contact a cardiologist was not inappropriate, breathing difficulties and tachycardia are symptomatic of severe anemia for which hematological care was required. If the Respondent determined that the symptoms were cardiac-related, the Respondent should have personally made the cardiology referral and provided the information to the cardiologist. The Respondent did not do so and was unaware of the cardiologist's identity. A review of additional lab test results including observation and evaluation of blood smears would have provided useful information as to whether the patient's condition was deteriorating and to whether the patient was developing thrombotic thrombocytopenic purpura ("TTP"), a serious condition which, left untreated, is fatal in not less than 90 percent of cases. The blood smears had been performed by the time of the phone call, but the Respondent reviewed no lab test results and made no inquiries related to the results. The failure to review lab test results may have delayed a diagnosis of TTP. While there was some disagreement between testifying witnesses as to whether or not the patient had TTP, Dr. Katta ordered that the patient be treated for TTP immediately upon his return on March 19, 2003, and there is no evidence that Dr. Katta treated the patient for TTP without reasonable cause to do so. The evidence clearly establishes that the Respondent failed to review the patient's test results that could have provided timely and useful information regarding the patient's condition. As to the Respondent's failure to locate the patient on March 18, 2003, the Respondent testified that the patient's last name was common, but the Respondent had not called Dr. Katta at the time she received the faxed list of his hospitalized patients to obtain additional identifying information. The Respondent did not request the information from the nursing staff during any of the telephone calls and made no effort to obtain the information prior to arriving at the hospital to make her rounds. The Respondent would have become aware of the patient's location had she attended to the patient's breathing difficulties and tachycardia on the night of March 17. She would have also likely reviewed the medical records and would have become aware of the admitting physician as well as other information regarding the patient's condition. The Respondent consulted with hospital personnel on March 18, 2003, in attempting to identify those patients admitted by Dr. Katta. There were approximately ten to 12 other hospitalized patients with the same last name, none of which had been admitted by Dr. Katta. The Respondent was unaware that the patient had been admitted under Dr. Leiva's name. The Respondent did not visit the ten to 12 patients with the same last name to locate the one for which she was responsible. The Respondent did not contact the blood bank, which had been having difficulty providing transfusion blood to the patient. It is reasonable to assume that the blood bank, charged with the responsibility to provide the appropriate blood supplies to the patient, would have been aware of the patient's location, and could have provided it to the Respondent. The Respondent made no effort to identify patients located in the hospital's intensive care units, despite the critical nature of the patient's condition at last report. Had she done so, she would have located the patient. The Respondent presented testimony that it was not uncommon for a physician, unable to locate a hospitalized patient, to routinely assume that the patient has been appropriately treated and has been discharged, or is deceased. However, the Respondent testified that it was unusual for her not to be able to identify and locate a patient. Even assuming that such practice is routine, it is unlikely that such an assumption could reasonably be made in the case at issue here, where the Respondent did not know the patient's name, had never seen the patient, had personally reviewed no medical records, was unable to find anyone in the hospital who could provide her with any information, and at last communication with the nursing staff had been told that a critically-needed transfusion had not occurred. The testimony is not credited and is rejected.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding Vasundhara Iyengar, M.D., in violation of Subsection 458.331(1)(t), Florida Statutes (2002), and imposing a penalty as follows: a three-year period of probation; a fine of $10,000; and such additional community service and continuing education requirements as the Department of Health determines necessary. DONE AND ENTERED this 31st day of January, 2008, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 31st day of January, 2008. COPIES FURNISHED: Jennifer Forshey, Esquire Dorys H. Penton, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 H. Gregory McNeill, Esquire Lowndes, Drosdick, Doster Kantor & Reed, P.A. Post Office Box 2809 Orlando, Florida 32802-2809 H. Roger Lutz, Esquire Lutz, Bobo & Telfair, P.A. 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent, Sanford L. Yankow, M.D., has been a physician licensed to practice medicine in the State of Florida. Respondent's license number is ME 0017585. Respondent is a Fellow of the American College of Obstetrics and Gynecology and is Board-certified in Obstetrics and Gynecology. He received his M.D. degree from the University of Miami School of Medicine in 1969 and then completed his internship and residency in obstetrics and gynecology at Jackson Memorial Hospital located in Miami. Dr. Yankow was the Chief Resident in Obstetrics and Gynecology from 1972 to 1973 and subsequently was an Instructor in the University of Miami Department of Obstetrics and Gynecology from July, 1973, through July, 1975. From 1975 through 1983, he was a Clinical Assistant Professor in the Department of Obstetrics and Gynecology at the University of Miami School of Medicine. Respondent is presently on the active staff of Baptist Hospital of Miami and is a member of the following hospital committees: Laser Committee, Tissue Committee, Cesarean Section Committee, PSCU Committee, Transfusion Committee, and Education Committee. He is a member of the American Fertility Society, the Miami OB/GYN Society, and the Florida Obstetrics and Gynecology Society. He is also a member of the Florida Medical Association, the Dade County Medical Association, and the American Medical Association. Respondent served as a medical consultant and expert witness to Petitioner, Department of Professional Regulation, from 1983 to 1985. The patient whose care is at issue in this case, S. E., was, at the time she was seen by Respondent, a 34-year-old married woman who was trying to get pregnant. S.E. was examined by Respondent on two occasions: June 20, 1983 and June 23, 1983. At the first examination of June 20, 1983, the patient filled out a new patient history questionnaire. This questionnaire was received by Respondent during the course of his examination, and his handwritten notations concerning the patient's history and examination appear on the back of this questionnaire. It is evident that Respondent reviewed the patient's questionnaire and discussed her history and presenting problems with the patient. Respondent also prepared typed progress notes pertaining to the patient's visits of June 20 and June 23, 1983. The progress notes also include an entry for June 22, 1983, when Respondent received and interpreted an HCG pregnancy test result. The patient came to see Respondent because she thought that she had just had a miscarriage. The medical records establish that the patient's last menstrual period was June 13, 1983, seven days prior to her office visit, and the patient continued to bleed. The patient also stated as part of her history that she had been trying to become pregnant, was two weeks late with her last period, and was using no contraception. The progress notes establish that the patient denied dysmenorrhea (painful periods), dyspareunia (painful intercourse), as well as post-coital or intramenstrual spotting. The patient's history also indicated that her mother has breast cancer, and that S. E. had irritable bowel syndrome. S. E. was not allergic to any medication, was not taking any, did not smoke or drink (except occasional wine), and did not use drugs. The patient did not indicate that she was experiencing pain, tenderness, or dizziness during either visit to Respondent's office. Respondent's notes regarding his physical examination of the patient on June 20 affirmatively state that the patient was "in no distress." Her weight was 110, and her blood pressure was 100/60. Respondent did a complete review of systems, including an HEENT (head, ears, eyes, nose, and throat), all of which were normal. He examined her neck, found her lungs clear, listened to her heart, examined her breasts, and found no masses or tenderness. Her nipples were erect and having no discharge. The abdominal exam revealed the abdomen to be soft and flat, with no masses and no tenderness. There was no tenderness of the back and no lymphadenopathy of the groin, and the extremities were normal. The pelvic examination revealed no masses or tenderness of the adnexa (the tubes and the ovaries). Her uterus was top normal size, anteverted, anteflexed, normal shape, and with consistency. The external genitalia and BUS glands were normal. Introitus marital was noted, with no lesions of the vagina. The pelvic examination also indicated bleeding from a slightly cyanotic cervix. The Respondent's diagnostic impression was a possible spontaneous abortion, which is commonly referred to as a miscarriage. Respondent's plan was to obtain a Beta HCG pregnancy test, get a pap smear, start the patient on basal body temperature charts, and obtain records from the patient's previous gynecologist. The Beta HCG and pap smear specimens were obtained during the first office visit of June 20, 1983. On June 22, 1983, Respondent received the HCG test result of 3440, which according to the laboratory performing the test indicates that the patient was in the fourth week of pregnancy. Respondent reiterated in his progress notes of June 22 that the uterus was top normal size, and Respondent concluded that with a serum HCG at 3440, the patient was in approximately the fourth week of pregnancy. He indicated that he would see her again in one to two weeks. On June 23, 1983, the patient returned. There is no indication that the patient returned because of pain or any new type of complaint. A second pelvic examination was performed on June 23, 1983, which also indicated that there were no adnexal masses. The uterus was anteverted, anteflexed, and was of normal size, shape, and consistency. Respondent repeated the Beta HCG pregnancy hormone test on June 23, and the results were reported on June 24, 1983. The Beta HCG report shows that the Beta HCG dropped from 3440 to 2100. Tracking the HCGs down until the level of pregnancy hormones reaches zero is appropriate to establish the regression of a pregnancy due to a spontaneous abortion or miscarriage. On June 27, 1983, the patient became shock-y and was taken to Hialeah Hospital. It was then discovered that the patient had a ruptured tubal pregnancy involving the proximal tube and part of the cornua. The patient was operated on and then did well. An "ectopic pregnancy" is a pregnancy which occurs outside the uterus and is usually located in a fallopian tube. When the pregnancy is located in a tube, it is referred to as a "tubal pregnancy." Subsequent to Respondent's care, it was discovered that this patient had an "interstitial" ectopic pregnancy. Only two percent of ectopic pregnancies are interstitial, and interstitial ectopics are the most difficult to diagnose. Petitioner offered proof through its expert witness, Dr. Robert Brauner, that Respondent committed medical malpractice by failing to diagnose and treat an ectopic pregnancy. On the other hand, the Respondent's expert witness, Dr. Manuel A. Penalver, testified by deposition that Respondent did not commit medical malpractice or fall below the prevailing standard of care by failing to diagnose or treat an ectopic pregnancy. Both Dr. Brauner and Dr. Penalver were provided with the exact same information from which to formulate their expert opinions--a copy of Respondent's medical records. From this exact same information, the two experts have formulated diametrically opposed opinions. Petitioner's expert, Dr. Robert Brauner, is an obstetrician and gynecologist in private practice in Tampa. He has been Board-certified in Obstetrics and Gynecology since 1983. Dr. Brauner has practiced medicine in a solo practice since April, 1983. In 1981, he was in a two-person practice for a year and a half, and he then went to another two-person practice for a little over one year. He is a Diplomat of the National Board of Medical Examiners and has been a consultant in gynecology to the Tampa Veterans' Hospital since 1983. Dr. Brauner is on the quality assurance committee at Humana Women's Hospital in Tampa. Respondent's expert witness is the Chief of Gynecology at the University of Miami School of Medicine. Since 1984 Dr. Penalver has been a full-time member of the Department of Obstetrics and Gynecology at the University of Miami. He has been awarded tenure and is currently an Associate Professor of Medicine. Dr. Penalver is Board-certified in Obstetrics and Gynecology and is also Board-certified in Gynecologic Oncology. He has authored numerous articles and publications, including textbooks and textbook chapters in the field of gynecology. He has been the recipient of many awards and honors for his clinical and teaching abilities. Dr. Penalver is ultimately responsible for all gynecological admissions to Jackson Memorial Hospital. He sees patients every day and frequently deals with the subject of ectopic pregnancies in his practice, both through his hands-on treatment of patients, as well as through discussions on the subject during hospital rounds. It is concluded from a review of the credentials of Dr. Penalver and Dr. Brauner that Dr. Penalver excels in professional recognition among his peers and that his expert opinions should be given greater weight than those of Dr. Brauner. Dr. Penalver testified that Respondent's diagnosis of a possible spontaneous abortion (commonly known as miscarriage) was the correct diagnosis based upon the information then known and was not a deviation from the prevailing standard of care for a Board-certified obstetrician and gynecologist. Dr. Penalver went even further by stating that this would have been his own diagnosis if he had examined the patient on June 20, 1983. Respondent's plan to get a pap smear, get a Beta subunit, start the patient on basal body temperature charts, and get previous gynecological records was well-formulated and within the standard of care. This case involved a very unusual presentation for a tubal pregnancy. The presenting symptoms and findings in this particular patient were such that a qualified gynecologist acting within the standard of care should not have been expected to have discovered the ectopic pregnancy. Ectopic pregnancies usually present with pain and dizziness, accompanied by vaginal bleeding, and a positive pregnancy test. There were no complaints of pain or dizziness stated by the patient on either of her two visits to Respondent's office. To the contrary, the patient was affirmatively found to be "in no distress." Upon physical examination, the patient had no pelvic tenderness, no tenderness of her back, and no masses or tenderness of the adnexa (ovary and tubes). Adnexal masses and tenderness are common signs of an ectopic pregnancy. They were not noted in this patient. The history provided by the patient and the physical examination performed by the doctor were inconsistent with an ectopic pregnancy. Instead, the history, physical examination, and Beta HCG tests were consistent with an early three to four week pregnancy that was in the process of miscarrying. It was most likely that this was a three to four week pregnancy, but, even assuming that this was a seven, eight, or nine week pregnancy as contended by Petitioner, Respondent did not breach the standard of care pertaining to the diagnosis and treatment of an ectopic pregnancy. Although the patient indicated that she had an irritable bowel syndrome, this was historical information. Respondent was made aware of her irritable bowel syndrome and included the condition in his progress notes along with other historical matters such as breast cancer in the patient's mother and the patient's allergies. If this was a current complaint, Respondent would have described the condition differently in his progress notes. Respondent ordered the appropriate laboratory test, the Beta HCG subunit testing for the pregnancy hormone. This test revealed an HCG level of 3440 on June 20, which according to the laboratory's own criteria, correlated with a four week pregnancy. The HCG result was consistent with Respondent's finding during the pelvic examination of a top normal sized uterus and correlated with Respondent's diagnosis of a spontaneous abortion. The drop of the HCG from 3440 to 2100 as occurred in this case was also consistent with a miscarriage and was inconsistent with an ectopic pregnancy. In an ectopic pregnancy, it would be expected that the HCG would be rising, but not at the rate of a normal pregnancy. The standard of care utilized by obstetricians and gynecologists in 1983 did not require that Respondent order an ultrasound of this patient. An ultrasound is not diagnostic and would not discover an ectopic pregnancy when the HCG level is below 6000. Respondent did not deviate from the standard of care by failing to provide ectopic precautions to the patient since an ectopic pregnancy should not have been suspected, based upon the patient's history and physical examination. Respondent did not deviate below the prevailing standard of care for Board-certified obstetricians and gynecologists in 1983 by failing to diagnosis or treat an ectopic pregnancy in this patient, S. E.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty of the allegations contained within the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 29th day of July, 1991, 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 Filed with the Clerk of the Division of Administrative Hearings this 29th day of July, 1991. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 90-7859 Petitioner's proposed findings of fact numbered 1-6, 8, 14, 20, and 35 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 7, 10-13, 15, 16, 19, 22-24, 26-29, 31, 33, 34, and 44 have been rejected as not being supported by the weight of the evidence in this cause. Petitioner's proposed finding of fact numbered 9 has been rejected as being subordinate to the issues involved in this cause. Petitioner's proposed findings of fact numbered 17, 18, and 21 have been rejected as being unnecessary for determination of the issues herein. Petitioner's proposed findings of fact numbered 25, 30, 32, and 36-43 have been rejected as not constituting findings of fact but rather as constituting recitation of the testimony, argument of counsel, or conclusions of law. Respondent's proposed findings of fact numbered 2-34 and 36- 51 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact but rather as constituting a conclusion of law. Respondent's proposed findings of fact numbered 35 and 52-60 have been rejected as being unnecessary for determination of the issues herein. COPIES FURNISHED: Mark A. Dresnick, Esquire 2400 One Biscayne Tower Two South Biscayne Blvd. Miami, Florida 33131 Richard A. Grumberg, Senior Attorney Department of Professional Regulation Northwood Centre 1940 N. Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Dorothy Faircloth, Executive Director Department of Professional Regulation Northwood Centre 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation Northwood Centre 1940 N. Monroe Street, Suite 60 Tallahassee, Florida 32399-0792
The Issue The issues in this case are whether Respondent violated section 458.331(1)(m), Florida Statutes, by failing to keep legible medical records that justify the course of treatment of a patient, as set forth in the Second Amended Administrative Complaint, and, if so, what is the appropriate sanction.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2015). The Board of Medicine is charged with final agency action with respect to physicians licensed pursuant to chapter 458. Dr. Velilla is a licensed physician in the state of Florida, having been issued license number ME 98818. Dr. Velilla's address of record is 12709 Miramar Parkway Miramar, Florida 33027. Dr. Velilla has been a medical director at Evolution MD since the summer of 2010. Dr. Velilla was licensed to practice medicine in the state of Florida during all times relevant to Petitioner's Second Amended Administrative Complaint. Dr. Velilla is Board-certified in internal medicine by the American Board of Internal Medicine. On or about December 29, 2010, Patient C.A. consulted with Dr. Velilla regarding possible abdominal liposuction and fat transfer to the gluteal area. These are cosmetic surgery procedures, undertaken with the object of enhancing the patient's appearance, and are purely elective. On or about February 10, 2011, Dr. Velilla performed an evaluation of Patient C.A. and ordered routine pre-operative laboratory studies. The laboratory report prepared by First Quality Laboratory indicated readings within normal limits for blood urea nitrogen (BUN) at 19.8 and creatinine serum at .7, but an abnormally high BUN/creatinine ratio reading of 30.43. It showed an abnormally high globulin reading at 3.40, an abnormally low INR reading of .79, an abnormally low MCH reading of 25.2, and an abnormally low MCHC reading of 30.7. On or about February 15, 2011, Dr. Velilla reviewed Patient C.A.'s pre-operative laboratory report results. He placed a checkmark next to the high BUN/creatinine reading and the low INR reading. He wrote "Rev." with the date and signed his name on each page. Dr. Velilla testified that he performed a glomerular filtration rate test, a calculation used to check on the functioning of the kidneys, and the result indicated normal renal function. He testified that a BUN/creatinine ratio outside of the normal range could be caused by several factors, and that after his assessment, the reading was not of concern to him in proceeding to surgery. Dr. Velilla did not make any notation on Patient C.A.'s medical records to indicate how or why he concluded that the abnormal BUN/creatinine ratio reading was not of concern. On February 24, 2011, Patient C.A. filled out a "General Consent" form. Patient C.A. agreed to disclose her medical history, authorized the release of medical records for certain purposes, agreed to use skin care products as directed, and acknowledged possible side effects from the use of skin care products. The form also stated, "I understand that Cesar Velilla, M.D. P.A. services generally consist of a series of treatment [sic] to achieve maximum benefit, and this consent shall apply to all services rendered to me by Cesar Velilla, M.D., P.A., including ongoing or intermittent treatments." On February 24, 2011, Patient C.A. filled out a "Medical History" form. Patient C.A. indicated she was not under the care of a dermatologist, did not have a history of erythema ab igne, was not on any mood-altering or anti-depression medication, had never used Accutane, had never had laser hair removal, had no recent tanning or sun exposure, had no thick or raised scars from cuts or burns, and had never had local anesthesia with lidocaine. The form did not ask for information about any prior abdominal procedures, previous liposuction treatments, multiple pregnancies, or abdominal hernias. On February 24, 2011, Patient C.A. signed a "Consent for Laser-Assisted Lipolysis Procedure SLIM LIPOSCULPT." The form did not include consent for fat transfer to the gluteal area or describe risks or possible complications of that procedure. Patient C.A. also signed a "Consent for Local Aneshesia [sic]" form. As Dr. Obi testified, the risks from a fat transfer procedure are generally the same as those of the liposuction procedure; although with a fat transfer, you have additional potential for fat embolism. On or about February 24, 2011, Dr. Velilla performed liposuction of the abdomen and thighs with fat transfer to the gluteal area on Patient C.A. at Evolution MD. Patient C.A.'s liposuction was not the "Slim Liposculpt" laser-assisted procedure. The testimony was clear that the "Slim Liposculpt" procedure would use a laser to melt the fat before liposuction, which could not be done on Patient C.A. because the fat was to be transferred. There was testimony that a laser could be used to improve skin retraction, however. As Dr. Velilla testified, Patient C.A. had requested the fat transfer in addition to the liposuction prior to the procedure. Dr. Velilla discussed the risks of both the liposuction and the fat transfer with Patient C.A., and she consented to have the procedure done. As Dr. Velilla testified, this consent was later documented on the operative report prepared sometime after the surgery and dated February 24, 2011, the date of the surgery. Dr. Velilla's testimony was supplemented by the operative report, which stated in pertinent part: The patient requested liposuction with fat transfer and understood and accepted risks including but not exclusive to bleeding, infection, anesthesia, scarring, pain, waves, bumps, ripples, contour deformities, numbness, skin staining, fluid collections, non- retraction of the skin, deep venous thrombosis, fat embolism, pulmonary embolism, death, necrotizing fasciitis, damage to surrounding structures, need for revision surgery, poor aesthetic result and other unexpected occurrences. No guarantees were given or implied and the patient had no further questions prior to the procedure. Other options including not having surgery were discussed and dismissed by the patient. The operative report adequately documented Patient C.A.'s earlier oral informed consent for liposuction with fat transfer. Patient C.A. did not execute a written informed consent for the fat transfer prior to the procedure. Dr. Velilla also noted in the operative report that the "patient physical examination and pre-operative blood work were within normal limits." Neither the operative report nor any other documentation indicated whether a complete physical examination or a focused physical examination was given, or what that examination consisted of. Patient C.A. was scheduled for a second liposuction procedure on her arms on February 26, 2011. It was decided to defer the procedure on her arms to this later date in order to keep the amount of lidocaine at a safe level during the initial procedure. On or about February 26, 2011, Patient C.A. presented to Evolution MD with complaints of nausea and mild pain. Dr. Velilla was not at the Evolution MD office. Mild pain is to be expected on the second day after a fat transfer procedure, and nausea can be anticipated in some patients who are taking opiods, as had been prescribed for Patient C.A. There was insufficient competent evidence in the record to support a finding that Patient C.A.'s symptoms were unusual or that Dr. Velilla was ever informed of more serious symptoms in Patient C.A. that day. Dr. Velilla spoke by telephone with an Evolution MD staff member about Patient C.A.'s symptoms and instructed the staff member to ask Patient C.A. to wait for his arrival at the office. A "Progress Note" signed on February 26, 2011, by Ms. Amanda Santiago, of Dr. Velilla's office, indicated that Patient C.A. said the pain and nausea were "due to the Vicodin." The note indicates that Dr. Velilla was called, that he stated he might stop the Vicodin and start Patient C.A. on Advil or Tylenol for pain, and that he asked that Patient C.A. be prepared for surgery. The note does not indicate that Dr. Velilla directed that Patient C.A.'s vital signs be taken, or that they were taken. The note states that Patient C.A. decided not to have the procedure on her arms done and that Dr. Velilla was again called. The note indicates that he asked the staff to take pictures of Patient C.A. and ask her to wait for him to arrive. Dr. Velilla did not order Evolution MD staff to take Patient C.A.'s vital signs. Her vital signs were not recorded by Evolution MD staff on February 26, 2011. Contrary to Dr. Velilla's request, Patient C.A. left Evolution MD on February 26, 2011, prior to Dr. Velilla's arrival at the office, and Evolution MD staff were unable to contact her. On or about February 27, 2011, Patient C.A. presented to Coral Springs Medical Center where she was admitted with a diagnosis of severe dehydration, intravascular volume depletion, diarrhea, nausea, and vomiting. Subsequently, Patient C.A. was admitted to the intensive care unit. Patient C.A. remained hospitalized until March 31, 2011. Standards and Ultimate Facts Dr. Obi is a surgeon specializing in plastic surgery. He does not conduct laser-assisted liposuction, but performs what is known as "wet" or "super wet" liposuction, as was performed by Dr. Velilla in this case. He has been a Diplomate of the American Board of Plastic Surgery since 1982. Dr. Obi reviewed Patient C.A.'s medical records from Evolution MD, other related records, and the Second Amended Administrative Complaint. Taken as a whole, Dr. Obi's testimony with respect to the medical history documented for Patient C.A. was not clear and convincing. He testified that Patient C.A. was undergoing a significant operative procedure and that it involved multiple anatomic areas. He also noted that the history did not include information as to whether Patient C.A. had prior abdominal surgical procedures, earlier liposuction, multiple pregnancies, or abdominal hernias. He testified that this information could indicate increased risks of injury and that this relevant history must be documented. Dr. Obi stated that in his opinion the patient history did not meet the minimum standards of the medical records rule. On the other hand, Dr. Obi seemed to have only a partial understanding of what the medical records rule required, and he had no opinion on whether the patient history justified the course of treatment of Patient C.A.--the actual statutory standard that Dr. Velilla was charged with violating in the Second Amended Administrative Complaint: Q. What does the rule say? A: What does the rule say? The medical record rule I believe requires – I can't tell you verbatim what it says. It requires adequate documentation so that in the event that the care of a patient has to be transferred to another healthcare professional the documentation is adequate that the patient, that the professional could immediately step in and take over. Q: Okay. You believe that's part of either the statute or the rule enacted by the Board of Medicine? A: If the Board of Medicine is the group responsible for the medical record rule, then I would say yes. Q: Okay. Have you reviewed what has been alleged in the amended administrative complaint, or second amended administrative complaint, as to the statutory provision for medical record adequacy? A: The statutory, I'm not sure that I have. * * * Q: And do you believe that the records fail to justify the course of treatment of the patient with those history findings? A: That's not what I said. I didn't say it failed to justify. What I said is it wasn't complete. Q: Okay, do you have an opinion as to whether the records fail to justify the course of treatment of the patient? A: No. Q: You don't have an opinion. Okay, thank you. In contrast, Dr. Soler testified that in his opinion the patient history that was documented as part of Patient C.A.'s medical records did justify her course of treatment. With respect to the physical examination, Dr. Obi noted that there was only a single line in the operative record stating that the physical examination was within normal limits. He noted that the documentation did not indicate what had been examined and did not record any specific findings or results of any examination that was conducted. However, he never offered an opinion that the record of the physical examination failed to justify the course of treatment of Patient C.A. Dr. Soler testified that in his opinion, the record of the physical examination did justify the course of treatment of the patient. Petitioner did not show by clear and convincing evidence that the documentation of Patient C.A.'s medical history and physical examination failed to justify her course of treatment. Dr. Obi testified that the medical records should have contained more evaluation or explanation of the abnormal laboratory report results: Q: And so was the check mark, when coupled with that note in the pre op, or in the operative report, sufficient documentation of Dr. Velilla's evaluation of the of the patient's pre-operative lab results? A: In my opinion, no. Q: And what do you base that on? A: If you have an abnormal result, I think it is incumbent on you – it – depending on what the abnormality is, and depending on what your interpretation of that abnormality is, it's incumbent to explain it. Sometimes you need to repeat the tests. Sometimes it may be perfectly within normal limits, but on the laboratory sheet, if it says that it's high, or out of the range of normal, I think other than just check mark, I think you just acknowledge what your thoughts are. Q: And do you remember if there was anything abnormal in Patient C.A.'s pre-operative laboratory results? A: There was one area that I commented on. That was the BUN-creatinine ratio. Q: And what is the BUN-creatinine ratio? A: It's just a ratio of some parameters dealing with kidney function. Q: Okay, and what does that lab result tell you about a patient, if anything? A: Well, you know, it can call your attention to the area, I mean, it can tell you, you know, that the patient has some renal issues. It can tell you that the patient is, you know, potentially dehydrated, it can tell you that the patient, you know, is within normal. But if the values are – if one value is high and the other one is low, it may give you a, a high reading. And that's understandable, but all you need to do is document that. It was Dr. Obi's opinion that the medical records failed to contain a sufficient evaluation or explanation of the abnormal BUN/creatinine ratio laboratory result. He acknowledged that the abnormal result was not necessarily indicative of a renal problem. However, Dr. Obi also testified: Q: Okay. Do you have an opinion as to whether those records are adequate to justify the course of treatment of the patient? A: The failure to document the thought process on this ratio would, in and of itself, not prevent or preclude the operative procedure from being done, if that's your question. At best, Dr. Obi's testimony was thus ambiguous as to whether or not failure to include an explanation of the abnormal laboratory result failed to justify the course of treatment of Patient C.A. Dr. Soler testified that no other documentation or chart entry was required to address the lab report value in order to justify proceeding with the surgery. Dr. Sandler testified that the BUN/creatinine ratio was a renal-related test, but does not itself indicate kidney malfunction. Dr. Sandler also testified that in his opinion, no other documentation was needed prior to proceeding with the surgical procedure. The Department did not clearly and convincingly show that the documentation in the medical records relating to abnormal laboratory results failed to justify the course of treatment of Patient C.A. Dr. Obi testified that Dr. Velilla had a duty to order the taking of Patient C.A.'s vital signs since he was not yet in the office when she returned on February 26, 2011, the date the second liposuction had been scheduled. He testified that if the medical records rule "requires doing what's appropriate at each visit," then Patient C.A.'s records did not meet the requirements of that rule. He testified that if Patient C.A. was an "outlier" in that her symptoms were uncommon, the standard of care required that Patient C.A.'s vital signs be taken. Dr. Obi admitted that there was no documentation in the medical records to suggest that Dr. Velilla had ordered the staff at Evolution MD to take Patient C.A.'s vital signs, but he testified that the order should have been given and that it should have been documented. Dr. Obi testified that there was no written documentation of an informed consent for the fat transfer and that the consent for the "Slim Liposculpt" procedure was consent for a procedure that was not done. Again, Dr. Obi seemed unfamiliar with the specific requirements of the medical records rule: Q: And is, is the –is a written documentation of the fat transfer required by the medical record rule in this case? A: In terms of the actual requirement, it would be my opinion that it should be required. Now, I can't say if it says that for every procedure, every surgical procedure, every invasive procedure, that a written consent must be documented; because obviously, you now, the patient consented. It's implied that the patient consented because she showed up for the procedure. Dr. Obi testified that he was aware that the operative report contained statements that Patient C.A. had been informed of the risks of the fat transfer procedure and that she had specifically consented. He admitted he was unsure as to "which board, or organization, or outfit" requires a written informed consent. Aggravating and Mitigating Factors No evidence was introduced to show that Dr. Velilla has had any prior discipline imposed. There was no evidence that Dr. Velilla was under any legal restraints in February 2011. It was not shown that Dr. Velilla received any special pecuniary benefit or self-gain from his actions in February 2011. It was not shown that the actions of Dr. Velilla in this case involved any trade or sale of controlled substances. On May 17, 2014, Dr. Velilla received a certificate showing completion of an FMA educational activity conducted in Jacksonville, Florida, entitled "Quality Medical Record Keeping for Health Care Professionals."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order dismissing the Second Amended Administrative Complaint against the professional license of Dr. Cesar Augusto Velilla. DONE AND ENTERED this 8th day of June, 2016, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD 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 8th day of June, 2016.
