Findings Of Fact Respondent is a licensed medical doctor holding a license to practice medicine in the State of Florida issued by the Board of Medical Examiners, Department of Professional Regulation. The Petitioner is a governmental agency charged with enforcing the provisions of Chapter 458, Florida Statutes, and related rules which regulate the licensure standards and status pertaining to medical doctors in the State of Florida, and enforcing the practice standards for licensed medical doctors embodied in Chapter 458, Florida Statutes. Steven Jones has been employed as a detective in the Narcotics Department of the City of Miami Beach Police Department for approximately three and one-half years. He is a ten-year veteran of the law enforcement profession. In December 1982, an investigation was initiated to determine whether allegations of misprescribing scheduled controlled substances made by a confidential informant against Dr. Ramos, the Respondent, were true. On December 16, 1982, Detective Jones entered the medical offices of the Respondent and asked to see Dr. Ramos. The Respondent's receptionist asked him to fill out a patient information sheet. On this sheet or form he indicated his name was "Steven James." He was then taken to the Respondent's office and met the Respondent. He told the Respondent that he was a construction worker, had recently experienced turmoil in his domestic life, and also suffered from a lumbo-sacral sprain. The Respondent then asked him if he had back pain and, after asking him general questions about his health and whether he suffered from any major illnesses, took out his prescription pad and wrote prescriptions for three medications. Other than the general questions the doctor asked him about his health, no detailed medical history was taken from Mr. Jones and there was no physical examination performed by Dr. Ramos or anyone else, except that his weight and height were recorded. No blood pressure reading was taken. After Dr. Ramos asked Mr. Jones if he had a backache, to which Mr. Jones responded in the affirmative, Dr. Ramos stated that he would prescribe something for the backache and something for stress that caused the backache, and something to sleep at night. Although no blood pressure was taken, Dr. Ramos did ask the patient how his blood pressure was, and the patient answered that it was "fine." The doctor then prescribed 60 tablets of valium, 60 placidyl tablets and 40 darvocet tablets. The only medical history provided in writing to the doctor concerned the name, address and employment, medical insurance information and answers to questions on the form concerning allergies. Additionally, the patient noted that he had been taking "valium" or "valium." Upon receiving the prescriptions, Steven Jones paid Dr. Ramos $40 and left his office. Detective Jones again visited Dr. Ramos' office on February 2, 1983. Upon arriving at the office he was escorted into an examining room by the Respondent's assistant, who was also his wife. While Mr. Jones was seated in the examining room, an assistant placed a blood pressure tourniquet or cuff on the patient's arm, leaving it there four to five minutes, when she ultimately returned to the room and informed Steven Jones that the doctor was ready to see him. The blood pressure tourniquet or arm band was never actually inflated by the Respondent or assistant, and no blood pressure reading was ever taken on this visit. Upon going into the Respondent's office, Mr. Jones was asked by Dr. Ramos about how he was feeling and the "patient" requested stronger pain medication. The doctor refused to do this, saying in effect that the patient, Mr. Jones, would have to be admitted to a hospital before the Respondent could prescribe stronger pain medication. Again, on this office visit no social or medical history was taken, and no physical examination was conducted at all. The Respondent asked the patient if he wanted the same prescriptions he had obtained at his December visit, and the patient answered in the affirmative. There was no discussion between the patient and the Respondent or anyone else concerning the patient's condition or progress between the December visit and this February visit. There was no discussion concerning the need for future treatment. The Respondent simply, at that point, wrote the same prescriptions given at the December visit. The next visit by Detective Steven Jones, a/k/a Steven James, occurred on May 25, 1983, at the Respondent's medical offices. The same medical assistant recognized Jones immediately when he came into the office and asked him if he was there for the same reason, to which he replied in the affirmative. He was then escorted straight to Dr. Ramos' office, who asked him if he wanted the same medication again, to which he assented. There was no discussion at all about his condition and how it may have progressed since the February visit, nor was there any discussions about future prospects for treatment, what treatment if any, was being considered or what it was designed to accomplish. The Respondent simply wrote three prescriptions once again, for valium, placidyl and darvocet, Schedule IV controlled substances. Except for the first visit, there was never any discussion of back pain nor any discussion concerning symptoms of insomnia and nervousness in this patient. Onelia Padron testified for Respondent. She has known the Respondent for many years and has worked for him as a technician for approximately a year. She was working in his office in December 1982, as an x-ray technician and in the performance of blood tests, blood pressure readings and physical therapy. She remembered Detective Jones coming to the office in December 1982, and testified that she did not take a blood pressure reading at the December visit, but did so at the February visit. Her specific memory of taking the blood pressure reading in February was not clear, however. She remembers specifically that his blood pressure was normal at the February visit and testified that she was sure that Dr. Ramos wrote down the blood pressure of the patient in his medical chart for the February visit. The patient medical record of Detective Jones a/k/a James, however, does not reveal that a blood pressure reading was taken at the February visit. Although the witness claims to have taken a blood pressure reading on the patient on his February 1983 visit, the testimony of Detective Jones reveals that no blood pressure reading was taken; although the blood pressure cuff or tourniquet was applied to his arm, it was simply not used. This may account in part for Ms. Padron's mistaken memory of actually taking the blood pressure reading. Her memory may be less than accurate due to passage of time. The testimony of Detective Jones to the effect that no blood pressure reading was taken, when considered with the Respondent's own medical records which do not reveal a blood pressure reading being taken, renders the finding inescapable that no blood pressure reading was taken at the February, 1983 visit and that Ms. Padron, after the passage of over a year, has a less- than-specific, inaccurate memory about the occasion and thus her testimony with regard to this visit is not credible. Rita Ramos, the Respondent's wife, acts as the office receptionist who makes and maintains the medical records for the Respondent. She performs no medical duties, however, she is well acquainted with her husband's handwriting and, of course, her own handwriting, and established that the word "valium" on Petitioner's Exhibit 2 and the word "valium" on Petitioner's Exhibit 6 were not written by her or her husband. She maintains that she specifically remembers the patient (Detective Jones) coming to visit Dr. Ramos on December 16, 1982, and she specifically remembers the doctor conducting a full physical examination and writing at least four lines of notes in the patient's record. She did not take a blood pressure on this patient in either December or February, however, and could not give an adequate explanation of how she could perform all her administrative record-keeping and maintenance duties and still have time to continually watch through the open door of her husband's office to see the physicals performed on approximately 20 patients a day, including Jones, and especially then to be able to remember the details of that one specific patient's visit in December 1982, over a year prior to the hearing. Although this witness supposedly remembered the doctor "always" conducting physical examinations on the first visit by a patient, and specifically conducting a head, eyes and ears examination on the first visit of Detective Jones, given the inherent interest of the patient in this case, the fact that her memory must be suspect regarding a specific patient's visit on a specific date more than a year prior to the hearing, and her own testimony that no irregularity or memorable occurrence happened during the visit of that patient to stimulate her recall, her memory of that event must be deemed less than accurate and therefore her testimony concerning the physical examination cannot be found credible by this Hearing Officer. Dr. Ramos testified on his own behalf. He stated that his standard practice is to interview and examine each patient and that he was especially suspicious of the subject patient who came in wearing earrings and boots. He interpreted his abbreviated notes on the patient's chart to reveal that the patient was 5'8" tall and weighed 145 pounds, had a blood pressure of 120 over 80 and a pulse of 80, and a normal sinus rhythm with no heart murmur and no abnormal respiratory signs. The doctor additionally interpreted his handwritten notes containing his own abbreviations, to reveal that the patient's eyes were normal, neck supple, with normal ears, nose, throat and a fair complexion. Although the patient asked for a stronger medication on at least one of the visits, including quaaludes, the doctor refused, informing the patient that he could not legally prescribe such for him in Florida. The doctor also testified that he remembered that on the second visit in February 1983, Ms. Padron took the blood pressure of the patient. He contends that he did not record the blood pressure reading because it was the same as the first time, that is, the December 1982 visit. No blood pressure was taken or recorded at the December 1982 visit, however, and none is revealed in the doctor's record for that visit. Although the doctor testified that on the February visit he believed that the patient might be trying to trick him and might be an undercover law enforcement officer, he still prescribed the same controlled substance prescribed earlier, with no additional physical examination made nor physical findings recorded in the patient records. He repeated the same instructions as to use of those drugs and the reasons for taking those drugs, but did not record any physical findings related to that visit. By his own admission, he did not ask the patient what had occurred in his medical history between December and February and did not ask questions concerning the success of his previously prescribed course of treatment. If indeed, the Respondent believed that the patient could be an undercover law enforcement officer and thus attempting to trick the doctor into misprescribing drugs for him, one might think that the doctor would take pains to make a thorough physical examination and to thoroughly record his findings and conclusions in the medical records he maintained, instead of failing to document his physical findings and conclusions and continuing to prescribe those drugs over a period of months. Thus, the testimony of Dr. Ramos is not supportive of a finding that a thorough physical examination, including the taking of blood pressure readings at each patient visit and, (in view of the low back pain complaint) straight leg raise tests, tests for impairment of sensation in extremities and other parameter checks, was actually conducted on the patient. Dr. John Handwerker, M.D., testified as an expert witness for the Petitioner. He has served as first chairman of the Department of Family Practice at the University of Florida Family and Community Medicine programs. He is Chairman of the Family Practice Department of Mercy Hospital in Miami, and is assistant professor of pharmacology at the University of Miami. He is knowledgeable regarding generally prevailing and accepted standards of family practice in Dade County and was accepted, without challenge, as an expert in the field of family practice. The drug Darvocet and Darvocet N-100 is a Schedule IV controlled substance, according to the schedule established in Chapter 893, Florida Statutes. Darvocet is characterized by some habituating influence, together with some problems with withdrawal. Its use is contraindicated with tranquilizers, such as valium, which was also prescribed in conjunction with it by Respondent for the patient involved herein. Valium, which is known generically as diazepam, is also a Schedule IV controlled substance and is a sedative or anti-anxiety drug with a wide variety of potentially adverse drug interactions, including darvocet. It can be mildly addictive, has a depressant effect on the central nervous system and is also a muscle relaxant. Placidyl is a short-term drug used in sleep disorders. It is only indicated for use for a maximum of seven days. It is classed as an oral hypnotic, and is a Schedule IV controlled substance pursuant to Chapter 893, Florida Statutes. Prior to prescribing any of these drugs, a physician should take a full history from a patient, and perform a thorough physical examination. The history should include the patient's chief complaint with questions from the physician to the patient involving areas of past problems with the nervous system, ears, eyes, lungs, chest, respiratory system, GI tract, and urinary tract. The physical examination should involve all body systems, including blood pressure, examination of the head, neck and chest and back regions. Further, if the patient requests these or other drugs specifically, a check should then be made for "track marks" and other evidence of prior drug abuse or usage. If the patient complains of low back pain, there should be a physical examination specifically involving the low back area before prescribing the scheduled controlled substances at issue. The past history is important to determine the duration of the problem, any previous medical treatment, examinations or tests by other physicians regarding the lumbosacral or low back area. A physical examination should be performed designed to elicit indications of neurological involvement, including straight leg raise tests, impairment of sensation tests in the extremities and other neurological inquiries. Such a full history and a physical examination is necessary prior to initiating a course of treatment involving treatment of chronic pain due to the existence of a wide assortment of other treatment modalities which might treat the root of the problem, rather than merely the pain symptoms. Dr. Handwerker, upon being questioned concerning the December 1982 visit of Detective Jones to the Respondent's office, posing as a 29-year-old construction worker complaining of lower back pain and insomnia, established that if a doctor performed no physical examination of such a patient, or only a cursory one, and took a history which in essence elicited only the complaint of injury (aside from the non-medical personal background information) that it would amount to inappropriate prescribing of the subject drugs if the patient was given these drugs in the manner prescribed to Detective Jones. The Respondent simply made insufficient findings upon which to base the decision to prescribe those drugs. Such prescribing without an adequate physical examination or the obtaining of detailed patient medical history would constitute a failure to conform to the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. The continued prescribing of these drugs at the February and May visits of this patient, without any discussion or consideration of the effect the previous course of treatment had had on the patient, other than a simple question by the Respondent concerning how the patient was feeling, also constitutes inappropriate prescribing of scheduled controlled substances and demonstrates a failure to conform to the generally accepted and prevailing standards of medical practice in the Dade County community. It was similarly established that the medical records failed to justify the course of treatment afforded this patient. Especially regarding the lack of a physical examination at each visit, and the failure to elicit any further medical history on the latter two visits. Even if a full physical examination and history was conducted on the first visit in December 1982, which was not the case, there would still be required an interim update and recording of physical findings related to the patient's experience since the December visit. Notes should have been made in the patient records regarding how the medications were affecting the patient and his pain problem, including notes reflecting that a physical examination had been performed, involving all vital signs, which was not the case with this patient. Not only does the generally accepted and prevailing standard of medical practice in Dade County require that an initial, thorough physical examination including the blood pressure and pulse and the eliciting of a detailed medical history be performed, as well as update physical examinations at later visits to check the progress of the patient under the treatment program; the failure to note the findings in the patient records constitutes a failure to conform to generally accepted and prevailing standards of medical practice for the Dade County community. Dr. Alfred March testified as an expert witness for Respondent, but agreed that the same detailed medical history and examination described by Dr. Handwerker is required before the practitioner should prescribe scheduled controlled substances in the same manner as done by the Respondent. Dr. March was unable to ascertain from simply reviewing the medical records of the Respondent, the reason or justification for the prescribing of any of the drugs on the three dates in question, and established that the medical records of the doctor should always justify the course of treatment for a patient. Indeed, Dr. March established that if a patient came in complaining of a backache, then such would be inappropriate prescribing without the performance of x-rays of the affected area and a full neurological examination, neither of which was performed by the Respondent in this case. Dr. Ramos has never been subjected to disciplinary proceedings in the past, and his past professional record reveals that his medical practice has been characterized by sincere concern for his patients and the highest respect of his colleagues. The subject drugs involved are Schedule IV controlled substances, which are of the class of drugs characterized by the least serious ramifications for patients, if misused. It is to the doctor's credit that when the undercover detective, Mr. Jones, attempted to persuade him to prescribe more powerful medication such as quaaludes, the doctor vigorously protested such a course of treatment and refused to do so, citing his belief that indeed it was illegal to do so in Florida.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefor
Findings Of Fact Dr. Steven D. Shanklin is a Doctor of Osteopathy, maintaining a general practice at 3304 Giddens Street, Tampa, Florida, 33610. During the year 1980, Dr. Shanklin treated numerous Medicaid patients and received payment for these services from the Department of Health and Rehabilitative Services as agent for Medicaid payments in the State of Florida. In 1981 the Department of Health and Rehabilitative Services conducted a routine, computerized assessment of payments made to its Medicaid providers. This assessment identified the respondent for further audit. A level two audit was conducted, which resulted in the Department of Health and Rehabilitative Services requesting 30 specifically identified patient files from Dr. Shanklin. The 30 designated patient files were identified as the result of a disproportionate random sample, which groups by the dollar volume of services rendered. In this method, the total dollar value of Medicaid services is divided by five and the total patient population divided into five subsets in which the value of the services rendered to all the patients in the subset equals 1/5 of the total dollar volume of Medicaid payments. The practical result of the disproportionate random sample is that the subsets become smaller as the dollar value of the services rendered for each individual patient becomes greater. Specifically, in this case, there were 471 patients in subset one, 202 in subset two, 130 in subset three, 78 patients in subset four, and 43 patients in subset five. A sample of six patients was taken from each subset for a total of 30. This is a statistically significant sample of Dr. Shanklin's total Medicaid patient population. Dr. Shanklin transmitted to the Department of Health and Rehabilitative Services 28 of the files specifically identified by the Department of Health and Rehabilitative Services. In addition, Dr. Shanklin provided the Department of Health and Rehabilitative Services two additional files for patients having the same last name as patients whose file had been requested by HRS. The Department of Health and Rehabilitative Services forwarded 30 files to the Peer Review Committee of the Florida Osteopathic Medical Association, which was chaired by Dr. H. Jerome Koser, D.O. The Peer Review Committee consisted of seven Doctors of Osteopathy, five of whom were general practitioners, and two of which were specialists. The Peer Review Committee set aside two of the files furnished them by the Department of Health and Rehabilitative Services, which contained no records. The remaining 28 files were divided among the seven reviewing doctors, each of whom reviewed approximately four files. The individual files were not assessed by the Peer Review Committee acting as a whole, or by a sub-grouping of the Committee. The Peer Review Committee identified seven files in which the reviewing Doctor determined there was over-utilization. In the Peer Review Committee's group discussion, the Committee determined that the over-utilization was minimal. As Chairman of the Committee, Dr. H. Jerome Koser prepared a letter of June 20, 1983 which published the Committee's findings. A copy of Dr. Koser's letter of June 20, 1983 was forwarded to the Department of Health and Rehabilitative Services together with the 30 files which HRS had forwarded to the Peer Review Committee. Upon receipt of the Peer Review Committee's findings, the assigned auditor and Orson Smith, M.D., specializing in Cardiology reviewed the files. Dr. Smith and the Department's auditor determined there was over-utilization in 18 of the 30 cases as indicated in the recoupment determination received as an attachment to petitioner's exhibit nine, the claim letter of October 11, 1983. Based upon the determination of over-utilization by the Department's auditor and Dr. Smith, a percentage of over-utilization in each of the five subsets was determined which was then extended to the total patient population and the amount of recoupment calculated. The recoupment determination form, referenced above, provides as follows: "This form explains how the amount of the recoupment was determined in the peer review process. All of the claims for the sample of recipients were returned to the Medicaid Office by the Florida Osteopathic Medical Association with a cover sheet indicating whether or not there exists misutilization or over-utilization for each recipient. The claims were then reviewed by the Medicaid Medical Consultant to determine the claims that were for services considered to be not medically necessary and that are consequentially being denied in light of the findings of the Peer Review Committee. This first step in the determination is to find the average amount paid, and the average overpayment for the recipients in each stratum of the sample as indicated in this chart:" Based upon the calculations, it was determined that Dr. Shanklin was overpaid $7,808.39.
Recommendation Having found that the amount of recoupment was not based upon the seven specific files identified by the Peer Review Committee as the rules require, it is recommended that the Department not recoup the $7,808.30 originally claimed. DONE and RECOMMENDED this 20th day of September, 1984, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of September, 1984. COPIES FURNISHED: Robert V. Pierce, Supervisor HRS Medicaid Investigative Services 1317 Winewood Boulevard Building 6, Room 271 Tallahassee, Florida 32301 Ted Mack, Esquire HRS Assistant General Counsel 1323 Winewood Boulevard Building 1, Suite 407 Tallahassee, Florida 32301 S. D. Shanklin, D.O., pro se 3304 East Giddens Avenue Tampa, Florida 33610
The Issue The issues for determination in this case are whether Respondent's license to practice osteopathic medicine should be revoked or otherwise disciplined for the reasons set forth in the Administrative Complaint, specifically for: 1) Respondent's failure to meet the acceptable standard of care for osteopathic medicine in his treatment of Patients S.R., K.P., R.Y., V.E., C.K., and S.P.; and 2) Respondent's failure to keep adequate medical records for the named patients.
Findings Of Fact Petitioner, Department of Health, is the state agency vested with the statutory authority to enforce the disciplinary standards for the practice of osteopathic medicine under Chapters 455 and 459, Florida Statutes. Respondent, Vincent Sundry, D.O., is and at all material times was, a licensed osteopathic physician in Florida, having been issued license number OS 001383. Central to the standard of care issues in this case is Respondent’s use of vitamin B-12 injections. Respondent testified that it is his practice to give patients 2 cc injections of B-12 "to get rid of lethargy and malaise." Respondent testified that he does not use B-12 to treat medical conditions. Respondent believes that B-12 improves the flow of oxygen in the blood and provides a boost of energy. It is also Respondent’s practice to mix ½ cc of B-12 with other medications to ease the sting of injections. Respondent testified that he learned this technique from a supervising physician at his osteopathic college in the 1950’s. In those days, medications such as penicillin were delivered in a heavy, syrup-like suspension, and the needles were of a larger gauge than is now common. Respondent’s supervising osteopathic physician believed that thinning the medicine with B-12 resulted in a less painful shot. Respondent adopted the practice and has maintained it throughout his career. Petitioner’s expert witness, Dr. Taylor, testified that B-12 shots are indicated only for pernicious anemia or an inability to absorb B-12 naturally. He testified that the only way to test for anemia or a B-12 loss is to draw a complete blood count ("CBC") and test the values of the hemoglobin. Dr. Taylor testified that giving B-12 injections to patients can be misleading, suggesting that it will make them feel better or have more energy when in fact it has no more effect than a placebo. Dr. Taylor stated that under some circumstances a placebo may be useful, but only as a last resort when conventional medications have failed. Dr. Taylor was also concerned that use of B-12 for such imprecise complaints as "lethargy" or "malaise" could lead to a delay in the correct diagnosis and treatment of the patient’s condition. Dr. Taylor conceded that B-12 is harmless, and that he has never seen a toxic or allergic reaction to B-12. Petitioner’s other expert, Dr. Latus, agreed that the accepted conditions for B-12 injections are pernicious anemia or a B-12 deficiency proven by blood tests. Dr. Latus also agreed that he was aware of no contraindications for B-12, and that the amounts of B-12 administered by Respondent were appropriate and not dangerous. Dr. Latus testified that some patients respond to placebos, but had no opinion on whether administering placebos constituted malpractice by an osteopathic physician. Respondent’s expert witness, Dr. Diamandis, also served as Respondent’s monitor during the 1992-1997 probation imposed on Respondent by an earlier order of the Board of Osteopathic Medicine. Dr. Diamandis testified that he has given B-12 injections to patients at their request, when the patients believed it would help them and after he had examined them. Dr. Diamandis summarized his view of B-12 as follows: It’s a funny thing, you can’t draw lines on B-12 and limit B-12, the use. You also cannot draw any lines and say you’re treating something when you give B-12, because it’s only a treatment for pernicious anemia, and it might also be a treatment for something else these days. Who knows. We’ve been drinking wine for a long time. Now they say it’s good for platelets to thin the blood a little bit . . . So I don’t think you can draw the line and say you shouldn’t use B-12. You can draw a line that says it’s only good for this that we know of. But a lot of people feel good when they get the shots. Maybe someone can come along and tell you why they feel good. Maybe a psychiatrist could do it. Dr. Diamandis did not accept Respondent’s use of ½ cc of B-12 to take the sting out of an injection as a method he would use in his own practice. However, he also declined to opine that Respondent’s method would constitute a deviation from the standard of care. Dr. Latus could not recall having been taught this method in his osteopathic training. As to several of the patients discussed in detail below, Petitioner pursued a theory that Respondent was using B-12 to treat conditions such as contact dermatitis, viral sinusitis, and ear infections, because the B-12 injections coincided with Respondent’s efforts to address those conditions. As stated above, Respondent denied that he ever used B-12 to treat any medical condition other than complaints of "lethargy" and "malaise." Respondent’s testimony on this point is credited. Petitioner failed to demonstrate that Respondent’s unorthodox use of B-12 constitutes a deviation from the standard of care. Patient S.R. Patient S.R., a 26-year-old female, first visited Respondent’s office on February 3, 1994, complaining of headaches caused by stress and tension. On March 2, 1994, Respondent treated S.R. for two abscesses in the upper right leg. Respondent cleaned the area of the abscesses, did a xylocaine block, incised and drained the abscesses, and bandaged the area. He gave S.R. injections of 1 cc of dexamethasone, a corticosteroid; 1 cc of lincomycin, an antibiotic; and ½ cc of B-12. Respondent testified that these injections did not go into the muscle tissue, but were done surficially around the abscesses. Respondent prescribed tetracycline, an antibiotic, and Librax to ease "the stress and strain going on in her nerves." Dr. Taylor testified that the dexamethasone was contraindicated, because injections of cortisone or steroids given at the time of an infection tend to blunt the immune system and slow the healing process. Dr. Taylor found this especially significant because S.R.’s infection was so serious that it had to be incised and drained. Dr. Taylor also found problematic Respondent’s failure to schedule a follow-up visit a few days later to assess the healing process. Dr. Taylor testified that lincomycin has a side effect profile so bad that the Food and Drug Administration removed oral lincomycin off the market. He testified that in 1994 there were other injectable antibiotics with fewer potential side effects that could have been given to S.R. Dr. Taylor testified that Respondent’s progress notes for S.R. simply set out a diagnosis and plan of treatment, without recording the size and duration of the abscesses, or the patient’s temperature, vital signs, or blood pressure. Dr. Latus testified that dexamethasone is not normally given in the case of an abscess or infection because it would have no effect. He agreed with Dr. Taylor that dexamethasone is a steroid that blunts the natural immune system, and thus should not have been used to treat S.R.’s abscesses. He also agreed that Respondent’s records did not sufficiently explain the situation or the reasons for the course of treatment Respondent pursued. Dr. Diamandis testified that he would not criticize the use of dexamethasone or some other anti-inflammatory in certain situations involving infections. However, the situations he described involved relatively extreme situations such as a patient with her throat so swollen there is concern that breathing will become obstructed, or a patient who is running a fever in the range of 104 degrees. These situations are not analogous to Respondent’s use of dexamethasone to treat S.R. Respondent testified that he administered the dexamethasone to take down the inflammation of the abscesses, in conjunction with the lincomycin to take down the infection. The evidence establishes that Respondent did not meet the applicable standard of care by administering dexamethasone for the treatment of Patient S.R.’s abscesses, and by failing to monitor the patient’s progress after the initial treatment. Respondent’s other actions in treating S.R., though subject to differences of opinion, met the standard of care. The evidence establishes that Respondent’s medical records failed to justify the course and scope of treatment concerning the use of dexamethasone. Respondent’s records failed to record such basic information as the patient’s vital signs, and recorded no specific observations concerning the abscesses. Patient K.P. On February 1, 1994, Patient K.P., a 56-year-old female, first presented to Respondent with a severe gastric upset. Respondent diagnosed gastritis and esophagitis. On March 4, 1994, Patient K.P. again visited Respondent. No complaint is noted for K.P. in Respondent’s notes. The notes indicate that K.P.’s weight was 193 pounds, her blood pressure was 130/82, and her heart tones and lungs were normal. Respondent decided to place K.P. on a weight regimen. He placed K.P. on thyroids; Lasix, a diuretic; and human chorionic gondatropin (HCG), a hormone produced during pregnancy. During a subsequent visit for the weight regimen on April 5, 1994, Respondent also prescribed Zestoretic, an antihypertensive combined with a diuretic. Respondent noted K.P.’s weight at 192 pounds during this visit. On April 26, 1994, K.P. visited Respondent complaining of bouts of vertigo. Respondent noted that her blood pressure had dropped to 114/78, and her weight was 188 pounds. Respondent also noted that K.P. was leaving for Canada, and he continued all the prescribed medications in larger quantities. Dr. Taylor testified that the use of HCG for obesity is inappropriate, because HGC is no more effective than a placebo for weight loss. Respondent testified that the HCG was not prescribed for weight loss but to treat menopausal syndrome in K.P., to "quiet her nerves" and help her lose weight. Respondent denied ever using HCG for diet patients. However, Dr. Diamandis, the probation monitor, recalled that Respondent had used HCG is the past for weight loss. Dr. Taylor disagreed with the use of Lasix for weight loss. He testified that Lasix artificially induces dehydration, giving the false appearance of weight loss. When the medication is stopped, the volume of fluids returns. Dr. Taylor testified that thyroids could induce a hypometabolic state, and has an adverse effect on the patient’s thyroid gland itself by discouraging the natural production of thyroid hormone. The thyroid gland can begin to dysfunction or decrease the amount of thyroid hormone it would make. Dr. Taylor stated that giving a patient thyroid for a period of weeks or months could induce hypothyroidism. Dr. Taylor also questioned the use of Zestoretic, noting that nothing in Respondent’s records for K.P. indicates hypertension. Dr. Taylor pointed out that this prescription, coupled with Lasix, meant that K.P. was now taking two diuretics, which would result in low blood pressure and a lower level of potassium and other salts in the bloodstream. Dr. Taylor testified that he was not surprised that K.P.’s chief complaints on April 26, 1994 were bouts of vertigo and decreasing blood pressure, as these symptoms were to be expected with the medications Respondent prescribed. Dr. Taylor concluded that Respondent’s treatment constituted a major safety issue for K.P. Respondent continued the prescriptions for K.P. when she went to Canada, without taking any steps to monitor her condition. Respondent’s records indicated no monitoring of the patient’s electrolytes, no chronic medication list, no chronic problem list, and no discussion of diet for K.P., despite the fact that she was seeing Respondent for weight loss. The evidence establishes that Respondent did not meet the applicable standard of care by administering thyroid, Lasix, HCG, and Zestoretic for the treatment of Patient K.P.’s weight problem. The evidence establishes that Respondent’s medical records failed to justify the course and scope of treatment concerning the use of thyroid, Lasix, HCG, and Zestoretic. Patient R.Y. Respondent’s records indicate that Patient R.Y. visited Respondent 39 times over the period from early March 1993 through September 26, 1994. Twenty-one of those visits, from March 1993 through February 1994, involved persistent contact dermatitis, a skin rash resulting from exposure to a primary irritant or to a sensitizing antigen. Upon his initial diagnosis of contact dermatitis, Respondent gave R.Y. injections of dexamethasone and Vistaril, a tranquilizer, as well as B-12. Respondent also prescribed an oral antihistamine. On nine subsequent visits, Respondent gave B-12 injections to R.Y. Dr. Latus testified that nothing in the medical record or his experience indicated that B-12 injections were appropriate treatment for contact dermatitis. As found above, Respondent denied that he used B-12 as a treatment for any condition other than lethargy and malaise, and that denial was credited. Aside from the use of B-12, Dr. Latus found nothing inappropriate in Respondent’s treatment of R.Y. Dr. Taylor joined Dr. Latus’ objection to the B-12 injections, and also criticized Respondent for seeing the patient 21 times over an 11-month period for contact dermatitis. Dr. Taylor opined that such a large number of visits without resolving the problem should have caused Respondent to refer R.Y. to a dermatologist. Respondent testified that he tried to refer R.Y. to a dermatologist, but that he refused to go because of the expense. Respondent stated that R.Y.’s condition was responsive to the treatment he was giving, but that the condition was caused by R.Y.’s working with concrete and stucco, and that R.Y. refused to find another line of work. Respondent concluded that until R.Y. was willing to quit working with the materials that were causing his problem, a specialist could not achieve any better result than Respondent. The evidence failed to establish that Respondent did not meet the applicable standard of care as to his treatment of Patient R.Y.’s contact dermatitis. Respondent’s medical records, while lacking descriptive detail of the color and quality of the rash, adequately justify the course and scope of treatment of Patient R.Y. Patient V.E. On March 15, 1994, Patient V.E., a 38-year-old female, presented to Respondent with a complaint of pain in the lateral left foot. Respondent’s records attribute the pain to a cheap pair of shoes that V.E. had worn for four or five days. Respondent diagnosed a severe ligamentous sprain, and possible falling arch. Respondent gave V.E. a one cc injection of prednisone, a steroid, and eight 375 milligram tablets of Naprosyn, an anti-inflammatory. On March 31, 1994, V.E. returned to Respondent, again indicating pain in her left foot, in the third and fourth metatarsal area, accompanied by edema. Respondent injected the area with xylocaine, a pain killer, then with dexamethasone. He prescribed Lasix to reduce the swelling. The only item in the treatment of V.E. that either Dr. Taylor or Dr. Latus found to be objectionable was an unrecorded injection of ½ cc of B-12. Both doctors opined that B-12 is not indicated for a foot sprain. Respondent testified that the B-12 was not administered to remedy the foot sprain, but to ease the sting of the dexamethasone injection. Respondent testified that he did not chart the B-12 because it was not used to treat anything, and it was only 1/2 cc to thin out the medicine. Respondent did record the 1/2 cc of B-12 in the shot records he was required to submit to the Board of Osteopathic Medicine as part of his probation. Dr. Taylor opined that the failure to include the 1/2 cc B-12 injection in the patient record constituted improper documentation. However, Dr. Latus expressly declined to opine on the question whether the failure to include the B-12 injection constituted improper documentation. The evidence failed to establish that Respondent did not meet the applicable standard of care as to his treatment of Patient V.E.’s ligamentous sprain. Despite their failure to include the 1/2 cc injection of B-12, Respondent’s medical records adequately justify the course and scope of treatment of Patient V.E. Patient C.K. Patient C.K.’s first visit to Respondent was on September 10, 1982, when he completed a medical history questionnaire indicating he was diabetic and took a "diabetes pill." The visits at issue in this case occurred in 1993 and 1994, when C.K. was in his early eighties. On March 9, 1993, Respondent diagnosed C.K. with back spasms and a pelvic tilt. Respondent applied osteopathic manipulative therapy, gave an injection of dexamethasone and ½ cc of B-12, and prescribed an anti-inflammatory medication. On April 1, 1994, C.K. visited Respondent with a complaint of pain in his left hip over the sciatic notch. Respondent repeated the injection of dexamethasone and B-12, and gave C.K. a refill of the anti-inflammatory medication. On April 2, 1994, Respondent recorded that C.K.’s hip pain had curtailed most of his activities, and a "probable need for radiological evaluation." Respondent recorded that C.K. was responsive to the osteopathic manipulative therapy, which restored some ability to bend, stoop, and move without pain. Respondent’s records do not indicate follow-up regarding the radiological examination, and do not indicate that X-rays were ever taken of C.K. Patient C.K. testified that he used to go to Respondent for his neck and back, but that Respondent never treated his diabetes. He recalled the manipulative therapy, and recalled requesting and receiving a B-12 shot from Respondent. He could recall receiving no X-rays. C.K. testified that he now works-out at the gym five or six days a week and suffers no back problems, but would return to Respondent if he did. Dr. Latus concluded that, aside from the B-12 injection, Respondent provided satisfactory and adequate care to Patient C.K. Dr. Taylor expressed concern about the B-12 and, more significantly, about Respondent’s administering corticosteroids to a diabetic patient, particularly where there is no record of what medication C.K. was taking for his diabetes. Dr. Taylor testified that corticosteroids elevate blood glucose, and should be avoided for diabetic patients unless they are in severe pain or unless corticosteroids are mandated for the patient’s condition. Dr. Taylor also criticized the lack of follow-up on the probable need for radiological examination. The evidence establishes that Respondent did not meet the applicable standard of care by administering dexamethasone for the treatment of Patient C.K.’s hip pain, given that C.K. was a diabetic. Because C.K. appeared to respond positively to the osteopathic treatments, Respondent’s failure to refer C.K. to a radiologist was within the standard of care. The evidence establishes that Respondent’s medical records failed to justify the course and scope of treatment concerning the use of dexamethasone. The records do not indicate the type of diabetes medication that C.K. was taking, or even an acknowledgment by Respondent that he took C.K.’s diabetes into account before administering dexamethasone. Patient S.P. Patient S.P., a 61-year-old female, visited Respondent only once, on April 1, 1994. She complained of vertigo, lethargy and malaise. She also indicated that, two to three weeks previously, she had a severe ear infection that was never treated. Respondent characterized S.P. as displaying overall myalgia, aching in her joints, hardly able to move. Her throat was swollen and inflamed. Respondent manipulated her back for the aches and pains, and manipulated her sinuses. Respondent diagnosed S.P. as having viral sinusitis, though he took no cultures to definitively diagnose the viral origin. He gave S.P. an injection of dexamethasone with ½ cc of B-12, and prescribed a ten-day course of vibramycin, a tetracycline antibiotic. Respondent testified that S.P. was on her way home to Michigan, but felt too sick to fly. His goal was to make her feel well enough to get home, at which point she would visit her own physician. Dr. Latus testified that, except for the B-12, the treatment of Patient S.P. was appropriate. Dr. Taylor testified that, aside from the B-12, Respondent misprescribed antibiotics to treat what he had diagnosed as a viral illness. Viral illnesses are not treated with antibiotics. However, Respondent could not definitively diagnose whether the infection was viral or bacterial without taking cultures. Under the rushed circumstances, Respondent prudently prescribed an antibiotic. At worst, the antibiotic would be ineffective; if the sinusitis was in fact a bacterial infection, the antibiotic would have a salutary impact. The evidence failed to establish that Respondent did not meet the applicable standard of care as to his treatment of Patient S.P.’s symptoms. Respondent’s medical records adequately justify the course and scope of treatment of Patient S.P. Conclusion In summary, the weight of the expert testimony and other evidence establishes that Respondent did not practice with an acceptable level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances as to Patients S.R., K.P., and C.K. The weight of the expert testimony and other evidence establishes that Respondent did practice with an acceptable level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances as to Patients R.Y., V.E., and S.P.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is recommended that the Department of Health, Board of Osteopathic Medicine enter a final order determining that Vincent Sundry has committed three violations of Section 459.015(1)(o), Florida Statutes, three violations of Section 459.015(1)(x), Florida Statutes, and revoking his license to practice osteopathic medicine in the State of Florida. DONE AND ENTERED this 14th day of April, 2000, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON 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 14th day of April, 2000. COPIES FURNISHED: John E. Terrel, Esquire Agency for Health Care Administration Practitioner Regulation-Legal A Post Office Box 14229 Tallahassee, Florida 32317-4229 Pamela A.M. Campbell, Esquire 535 Central Avenue, Suite 403 St. Petersburg, Florida 33701 Howard H. Whittington, Esquire 1100 Cleveland Street, Suite 900 Clearwater, Florida 33755 Bill Bukhalt, Executive Director Board of Osteopathic Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1701 William Large, General Counsel Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, Florida Statutes. Respondent is a licensed physician in the State of Florida and holds license number ME 0043566. Respondent has never been the subject of a previous complaint from the Department of Professional Regulation (now the Department of Business and Professional Regulation). No patient involved in this proceeding incurred injury as a result of any procedure performed by Respondent or as a result of any medical record kept by Respondent, nor did any patient claim injury or make a complaint against Respondent. Respondent derived no financial gain from any act or omission alleged in the administrative complaint. All events pertaining to this proceeding occurred in 1987 or 1988. Prior to February 8, 1988, the effective date of Chapter 88-1, Laws of Florida, Section 458.331(1), Florida Statutes provided, in pertinent part, as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, and test results. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure 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", shall not be construed to require more than one instance, event, or act. Section 25 of Chapter 88-1, Florida Statutes, became effective February 8, 1988, and amended the pertinent provisions of Section 458.311(1), Florida Statutes, to read as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, test results, records of drugs prescribed, dispensed, or administered, and reports of consultations and hospitalizations. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure 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", shall not be construed to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph. At the times pertinent to this proceeding, Petitioner had adopted no rules pertaining to the keeping of records by a licensed physician. Imperial Point Medical Center (Imperial Point) is a hospital located in Broward County, Florida. Unless otherwise indicated, all hospital records referred to in this matter are from Imperial Point. PATIENT #1 (C.S.) On August 8, 1988, Respondent performed an upper endoscopy on Patient #1, a male, who was 44 years old at the time of the procedure. This procedure was performed at Imperial Point on an outpatient basis. An upper endoscopy is the viewing of the mouth, the pharynx, the esophagus, the stomach and portions of the duodenum with a fiber optic instrument that allows direct visualization of the lining of these structures and allows therapeutic maneuvers. The records kept of this procedure performed on Patient #1 on August 8, 1988, include an outpatient hospital record entitled "Operative Report". The description of the procedure portion of this report includes the following: ". . . The gastric portion was infiltrated with 1:1,000 adrenaline . . ." Adrenaline, also known as epinephrine, is a vasoconstrictor that can be used to control minor bleeding and oozing. It is used regularly in gastroenterology to treat actively bleeding lesions or ulcers with evidence of recent bleeding prior to performing a more permanent type of hemostasis. Dr. Goldberg testified that epinephrine was usually injected into these areas by a needle. Dr. Goldberg was of the opinion that epinephrine should not be used in cases of trivial bleeding or oozing or after routine biopsies unless there is an imminent danger of a significant arterial bleed. The testimony of Dr. Cerda and Dr. Singh established that spraying epinephrine over an area that is subject to bleeding is a precautionary technique some gastroenterologists follow. Dr. Singh and Dr. Cerda have both either used this technique, or have observed its use by other physicians. The expert witnesses agreed that the injection by needle of epinephrine into the gastric wall would be a procedure that falls below an established standard of care. There was a dispute among the expert witnesses as to how the term "infiltrated" should be interpreted. Petitioner contends that the term "infiltrated" is synonymous with the term "injected", and that the medical records should be construed to mean that Respondent injected the gastric wall with a needle, and therefore practiced below the standard of care. This contention is consistent with the testimony of Dr. Goldberg. Respondent asserts that the medical record should be construed to mean that Respondent sprayed the gastric wall as a precautionary measure. This contention is consistent with the testimony of the expert witnesses who testified on behalf of the Respondent. This dispute is resolved by finding that the term "infiltrated" does not have the same meaning as the term "injected" and does not prove that Respondent injected Patient #1's gastric wall with a needle. This conclusion is based, in part, on the definition of the term "infiltrate" and on the context in which epinephrine is sometimes administered by gastroenterologists during this type procedure. According to The American Heritage Dictionary of the English Language, the term "infiltrate" means to pass a liquid or a gas into something through its interstices or to permeate with a liquid or gas passed through interstices. Dorland's Illustrated Medical Dictionary, Twenty Sixth Edition (Dorland) has a similar definition of the term "infiltrate". According to Dorland, an "interstice" is small interval, space, or gap in a tissue or structure. According to Dorland, the term permeate means to penetrate or pass through, as through a filter. Also according to Dorland, the term inject means the act of forcing a liquid into a part, as into the subcutaneous, the vascular tree, or an organ. Based on these definitions, it is found that the use of the term "infiltrate" is more consistent with the practice of spraying epinephrine onto the gastric wall, and that the use of the term "infiltrate" does not prove that Respondent injected the epinephrine into the gastric wall with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #1 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. A pathology report dated August 8, 1988 contained in the medical file provided a pathological diagnosis as follows: "esophageal brushings: no evidence of malignancy." Brushings are the result of passing a small brush through the biopsy channel of an endoscope, rubbing it over an area of concern that might have either a malignancy or a fungal infection, taking the brush out of the scope, wiping it on a microscopic slide, and sending the slide to the pathologist for cytological examination. The reference to the "esophageal brushings" in the pathology report was error. The brushings taken from Patient #1 during the procedure on August 8, 1988, came from the stomach, a fact obvious to all of the expert witnesses in light of the operative report and operative drawing made by Respondent. Because Petitioner failed to prove that Respondent took esophageal brushings from Patient #1, its charge that he failed to properly document his reasons for doing so must also fail. 1/ Petitioner proved that Respondent's medical records, including his office notes as to Patient #1 failed to contain an adequate medical history for Patient #1 and failed to reflect the findings of any physical examination of Patient #1 by Respondent. Petitioner further proved that such failures fall below an established standard of care as alleged in Count Two of the Amended Administrative Complaint. PATIENT #2 (R.B.) Patient #2 was a 70 year old male seen by Respondent for a consultation because of the patient's history of hematemesis, which is the vomiting of blood. Respondent prepared a formal consultation note dated September 25, 1988. The consultation note contains a description of the patient's condition, references a rectal exam, which was positive for blood, and indicates that a physical examination of the patient was made. Respondent again saw the patient on September 27, 1988 and performed an upper endoscopy. Dr. Goldberg was critical of the medical records kept by Respondent as to this procedure and was of the opinion that the medical records were inadequate. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedure. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records pertaining to this patient were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. The records kept of this procedure reflect that Respondent "infiltrated" Patient #2 with epinephrine. This is the identical dispute over the meaning of the term "infiltrated" that pertained to Patient #1 as discussed above. For the reasons given in resolving the dispute as it pertains to Patient #1, it is found that the term "infiltrated" does not have the same meaning as the term "injected" and that the use of the term does not prove that Respondent administered the epinephrine by injecting Patient #2 with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #2 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. PATIENT #3 (B.B.) Patient #3, a 65 year old female was admitted to Imperial Point with chest pains by her physician, a Dr. Fanfan. Patient #3 had a history of cancer which included the prior surgical removal of a tumor. On October 3, 1988, Respondent performed a colonoscopy of Patient #3. A colonoscopy is an examination of the colon from the anus to the ileocecal valve using a fiber optic instrument. A colonoscopy is indicated to evaluate abnormal X-rays, changes in bowel habits, evidence of bleeding, suspicions of inflammation, tumors, or polyps. Respondent adequately performed the procedure on Patient #3. The colonoscopy detected that Patient #3 had polyps. Subsequent laboratory results established that these were hyperplastic polyps that required no follow-up. Had the polyp been an adenomatous polyp, which is a true neoplasm with malignant potential, a follow-up for recolonoscopy would have been appropriate in one year. Prior to receiving the pathology reports, on the polyp, Respondent recommended a six month follow-up for the patient. This follow-up recommendation was appropriate at the time it was made. Petitioner failed to prove that the recommendation that a follow-up be performed was below an established standard of care. Petitioner failed to prove that the recommendation that the follow-up for this patient with a history of cancer be in six months as opposed to one year fell below an established standard of care. The barium enema for this patient was originally scheduled by the attending physician, Dr. Fanfan. Dr. Fanfan clearly wrote a note on the same day following Respondent's report of the colonoscopy that the barium enema was pending, yet the attending physician did not cancel the barium enema. There is no disagreement among the experts that the barium enema was unnecessary in light of the findings of the colonoscopy. It is medically unnecessary and inappropriate for both tests to be performed on the same day. Dr. Goldberg was of the opinion that Respondent was responsible for the patient once he began his consultation and that Respondent should have canceled the barium enema. Dr. Cerda, Dr. Eberly and Dr. Singh were of the opinion that the attending physician was responsible for scheduling the barium enema and that the attending physician or the radiologist should have canceled the barium enema. Dr. Eberly testified that as the primary care physician, the admitting physician is the "captain of the ship" and has the responsibility to make final determinations with respect to tests of this nature. Because of the conflicting testimony from equally credible expert witnesses, it is found that Petitioner failed to prove that Respondent violated an established standard of care by not cancelling Patient #3's enema. Dr. Goldberg was of the opinion that Respondent's medical records pertaining to Patient #3 were inadequate. He had several criticisms of the records. Dr. Goldberg opined that there should have been a formal consultation note on Patient #3's chart that included past history, present illness, review of systems, allergies, pertinent laboratories, a thorough organ specific or system examination, an impression, an adequate discussion of the consultant's impression and the consultant's plans. He opined that the indications for Patient #3's procedure were inadequately dictated on the procedure notes and that Respondent's history pertaining to Patient #3 was inadequate because there was no pertinent review of systems or past history, no mention of the previous tumor, no mention of allergies, and an extremely scant examination. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of this patient's medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #4 (E.K.) On October 4, 1988, Patient #4, a 92 year-old female, was admitted to the hospital with an acute onset of vomiting, dehydration, and abdominal pain. Respondent was asked by Patient #4's attending physician to evaluate Patient #4 for a potential small bowel obstruction following an X-ray that was consistent with a small bowel obstruction. Respondent performed an upper endoscopy on Patient #4 on October 7, 1988. An obstruction of the intestines is a blockage in the large or small intestine. The bowel behind the blockage may become inflated with fluid or air and may be seen on X-ray. The obstruction may result from a variety of abnormalities. Dr. Goldberg was of the opinion that the upper endoscopy was contra- indicated and potentially dangerous to the patient because of the X-ray indicating a complete bowel obstruction. Dr. Goldberg was also of the opinion that an upper endoscopy should be used only under compelling circumstances if there is a partial bowel obstruction. Dr. Goldberg was of the opinion that Respondent did the right tests on Patient #4, but in the wrong order since he did not first rule out an obstruction. Prior to performing the upper endoscopy Respondent monitored the patient for several days. During that time period, examinations indicated that the patient was having bowel movements. Both the attending physician's notes, Respondent's notes, and the nurse's notes indicate positive bowel signs on October 5 and 6, indicating that there was not a complete bowel obstruction. Respondent ordered a Golytely preparation administered to the patient, which usually consists of one or two liters of non-absorbable solution that basically washes the bowel out. That preparation would have been improper with a complete bowel obstruction. Dr. Goldberg was of the opinion that the use of a Golytely prep in this patient was a gross judgment error. Dr. Singh was of the opinion that there was no contra-indication for using the preparation in this situation. Petitioner failed to prove that Patient #4 had a complete bowel obstruction or that the procedure, including the use of the Golytely preparation, violated an established standard of care. It is found that Respondent was acting within the scope of his discretion as the consulting physician to order the administration of the Golytely preparation and to perform the upper endoscopy. On October 11, 1988, Respondent performed a colonoscopy on Patient #4. Respondent stated on the operative report that the colonoscopy was indicated because of diverticulitis. Diverticulitis was not mentioned in any of Respondent's notes concerning Patient #4, and there was no notation as to the reasons Respondent thought the patient had diverticulitis. Although Respondent failed to document why he felt that diverticulitis was an appropriate indication for the colonoscope, there is no dispute that a colonoscope was, in fact, indicated. Further, the colonoscope established that the pretest diagnosis of possible diverticulitis was not incorrect. The colonoscopy revealed areas of colitis, and the pathology report noted an ulcer with acute and chronic inflammation. Respondent's experts testified that they were of the opinion that Respondent violated no established standard by listing diverticulitis as an indication for the colonoscopy. It is found that Petitioner failed to prove that Respondent practiced below an established level in listing diverticulitis as an indication for the colonoscope. During the colonoscopy, Respondent found several mildly bleeding areas and infiltrated Patient #4 with epinephrine. For the reasons discussed pertaining to Patient #4, it is found that Petitioner failed to prove that Respondent violated an established standard of care in administering epinephrine to Patient #4. Dr. Goldberg was of the opinion that Respondent's handwritten consultation report was inadequate. Dr. Goldberg bases his conclusion on the following observations. The report was difficult to read and failed to include any significant historical events concerning Patient #4. In his consultation report, the Respondent failed to note anything about having done a rectal examination on this patient, whether or not the abdomen was distended, and whether there were active or inactive bowel sounds. Dr. Goldberg was of the opinion that these findings would help to distinguish between an obstruction and an ileus or paralysis of the bowel. Dr. Goldberg was also of the opinion that the patient's records of the upper endoscopy performed October 7, 1998, fail to reveal any significant findings. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #5 (J.T.) Patient #5, an 89 year-old male, was admitted to Imperial Point with a history of peptic ulcer disease and arthritis. This patient was seen by Respondent on a consulting basis. The patient was vomiting blood and Respondent was asked to see the patient to determine the source of the bleeding. Respondent performed an upper endoscopy on October 13, 1988, and found a significant outlet obstruction. On October 17, 1988, a G.I. series was performed and a repeat upper endoscopy and pyloric dilatation was performed. The procedures performed by Respondent were properly indicated and had a beneficial result to the patient. Back-to-back pyloric dilatations were appropriate and clinical judgment was properly exercised. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the upper endoscopy of October 13, 1988, in that Respondent's operative report failed to document Respondent's findings in detail. Dr. Goldberg testified that an essential endoscopy report that physicians are trained to do should include the following: indications for the procedure, medication used to sedate the patient, identification of instrument used, description of the anatomical landmarks and their condition as visualized by the physician passing the endoscope, the removal of the scope, the physician's impressions and what the physician plans to do about those impressions, how the patient tolerated the procedure and what the patient's condition was after the procedure, and that the patient was sent to the recovery area. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the procedures performed on this patient on October 17, 1988, in that Respondent's operative report did not document Respondent's findings in detail and did not indicate if the scope was passed through Patient #5's dilated pylorus into the duodenum. In Respondent's impressions on the second endoscopy, he noted pyloric stenosis and duodenal ulcer. In his procedure note Respondent does not mention whether he passed the scope into the duodenum or how he knew there was a duodenal ulcer. Dr. Goldberg was of the opinion that Respondent did not properly document what he did. On October 18, 1988, Respondent performed a repeat pyloric dilation on Patient #5. Dr. Goldberg was of the opinion that Respondent failed to record the reasons for the second procedure and to document his findings. Dr. Goldberg was of the opinion that the third endoscopy note did not adequately detail the examinations of the esophagus and stomach. Dr. Goldberg was of the opinion that every procedure note stands alone, and that if a physician does an endoscopy on day one and repeats it on day two, the physician still must make that report complete because it is not always going to be part of a document. Dr. Goldberg was of the opinion that Respondent's records did not stand alone. Dr. Goldberg was of the opinion that Respondent's handwritten consultation note was sketchy and should have contained a history of allergies because of the need to give the patient medications for sedation. Dr. Goldberg's criticisms of Respondent's medical records do not prove that the medical records kept by Respondent were inadequate as measured by an established standard. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedures and that the records were adequate. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #6 (D.Y.) From October 19, 1988, until October 22, 1988, Respondent was consulting physician to Patient #6, a 72 year-old male, who was admitted to Imperial Point with rectal bleeding. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to Patient #6 because a formal consultation note was lacking. The medical records which were reviewed by Dr. Goldberg were incomplete when reviewed by him. A specific reference is made to a consultation note that is not contained in the hospital records. Respondent established that other medical records were missing from the hospital records. In light of the specific reference to the consultation note, it is found that the absence of this consultation note from the hospital records is insufficient to prove that there existed no consultation note. On October 20, 1988, Respondent performed an colonoscopy on this patient and a biopsy was taken in the segmental descending colon area. The colonoscopy could not be completed because the colonoscopy could not pass to the patient's cecum. The following recommendation was made by Respondent (the original is in all capital letters): IN VIEW OF NOT REACHING TO THE CECUM, THE PATIENT WOULD NEED BE (this is an abbreviation for barium enema) AND ALSO IF EVERYTHING IS NEGATIVE, RECOLONOSCOPY IN ONE YEAR AND IF THERE ARE ANY CHANGES IN THE BIOPSY OF THE POLYP, THEN ACCORDINGLY WILL PLAN. On October 21, 1988, the follow-up barium enema was performed by Dr. Nicholas M. Arfaras, a radiologist. The radiology report reflected the following finding: "Also in the sigmoid there is an approximately 1 cm. rounded filling defect identified near the junction with the descending colon. This is felt to be secondary to a polyp." The possible polyp detected by the barium enema should have been followed up. However, it was not established that Respondent was consulted by the attending physician about the results of the barium enema. Dr. Lipton, as the attending physician, would have had the responsibility for following up the recommendations made by Respondent and for bringing Respondent or another gastroenterologist in for further consultations following the barium enema if Dr. Lipton had believed it necessary to do so. This patient was discharged from Imperial Point by Dr. Lipton on October 22, 1988. The final page of the discharge summary for this patient reflected the following notation: "Condition was improved. The patient is to have a follow up in one week in the office with Dr. Lipton and with Dr. Gupta in two weeks." The evidence presented in this proceeding, including Respondent's office notes, does not reflect that Respondent had any involvement with this patient after October 21, 1988, until 1990, when he performed on the patient at North Broward Medical Center a procedure described as a "multiple colonoscopy with multiple biopsies and cauterization." This procedure in 1990 revealed multiple polyps. The polyp removed on colonoscopy in 1988 was an adenomatous polyp, a polyp with significant malignant potential. This patient needed a follow-up colonoscopy in one year. Respondent was the consulting physician and recommended reevaluation of the patient in one year. Follow-up care was not the responsibility of Respondent, but of the treating physician. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records in that Respondent failed to adequately document the indications for the colonoscopy performed on Patient #6 and why the colonoscope could not be passed to Patient #6's cecum. Dr. Goldberg opined that a physician doing a colonoscopy needs to tell why he did not get to the cecum so that the next physician colonoscoping this patient can take appropriate precautions. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #7 (C.R.) Respondent was a consulting physician to Patient #7, a 64 year old male who was hospitalized with rectal bleeding. Respondent saw this patient because of a possible colonic fistula, which is a connection with any piece of the intestine and some other structure. Respondent recommended a barium small bowel X-ray and a barium enema, both appropriate clinical recommendations. On November 11, 1987, Respondent performed a colonoscopy on Patient #7. Petitioner contends that Respondent failed to keep adequate written medical records pertaining to the aforementioned procedure in that Respondent failed to document an adequate history as an indication of Patient #7's colonoscopy. This contention is rejected based on the testimony of Dr. Singh. The medical records provide adequate justification for the procedure. Dr. Goldberg was critical of Respondent's records pertaining to this patient and considered the records inadequate. He was of the opinion that the records should have better detailed his findings and should have recorded any follow-up plans for a repeat colonoscopy on the patient. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a final order which finds that Respondent violated the provisions of Section 458.331(1)(m), Florida Statutes, by failing to provide a history or physical examination for Patient #1 as alleged in Count Two, which reprimands Respondent for that violation, and which imposes an administrative fine in the amount of $250.00 against the Respondent for that violation. It is further recommended that all other charges against Respondent contained in the Amended Administrative Complaint be dismissed. DONE AND ENTERED this 12th day of October, 1993, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 12th day of October, 1993.
Findings Of Fact Dong Hack Koo, M.D., is a licensed physician in the State of Florida, having been issued license number ME 0027494. Koo was so licensed at all times material to the Amended Administrative Complaint. At all times material to this cause, Koo maintained an office at 121 East 8th Street, Jacksonville, Florida, 32206. On July 10, 1985, Diane Rabideau, an Investigator for the Department of Professional Regulation, inspected Koo's offices and found them to be unclean, with evidence of roach eggs present under a sink. Rabideau also found a rectal speculum and two vaginal speculums lying on a sink. Koo told Rabideau that the rectal speculum and the two vaginal speculums had been used. No evidence was presented to indicate how long the speculums had been on the sink. If such instruments are not cleaned quickly and properly following use, there is a high chance of spreading infection to the next patient to use the instrument. Such instruments should be placed in a cleansing solution and scrubbed, then wrapped and sterilized. It is the community practice to clean such instruments as soon as possible after use. According to Dr. Rosin, any physician who performs abortions in an unclean office with instruments lying around that have not been properly cleaned, has practiced below the community standard of care. However, no evidence was presented to show that Koo performed abortions under such circumstances. Koo does perform first trimester abortions in his office. It was not disputed that abortions are a medical and surgical procedure which can be dangerous. Emergency situations can arise during abortions and these emergencies require the presence of emergency equipment such as suction and the ability to start an intravenous medication. Koo does maintain suction equipment and intravenous solutions in his office. However, when possible he immediately transfers emergency patients to another facility. Koo does perform abortions in his office without the presence of an assistant to aid in emergency situations. According to Dr. Rosin, the standard of care in the community requires that an assistant be present during an abortion to assist the physician should an emergency situation arise. Additionally, according to Dr. Rosin, a physician who performs abortions without emergency equipment or without an assistant has failed to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. When Rabideau visited Koo's office on July 10, 1985, she obtained a sampling of drugs kept by Koo for dispensing to patients. The sampling revealed that a majority of the drugs had expired. However, no evidence was presented that this is a violation of Florida Statutes. Rabideau also found that Koo maintained a number of Schedule III, IV, and V, controlled substances in his office which he dispensed to patients. In dispensing these controlled substances, Koo used the instructions for use which are printed on the packaging. He also, at times, taped a small piece of paper to the packaging with his telephone number and the name of the patient. Koo did not completely label these controlled substances, which he dispensed, with his name and address, the date of delivery, directions for use, the name of the patient, and a warning concerning the transfer of the substance. Koo maintains no inventory of the scheduled controlled substances which are kept in his offices and dispensed to his patients. On August 6, 1985, Diane Rabideau again visited Koo's office. While Rabideau waited, a female patient by the name of Mary Green was seen by Koo and left with a prescription. Rabideau then asked Respondent to present the medical records on the patient, Mary Green. Koo was unable to present any medical records for the patient which he had just seen and to whom he had just dispensed medication. Koo's office procedure regarding patient medical records is to record histories and examination results on the patient medical records during the patient's visit. These medical records are kept in individual folders under the name of each patient. When a patient presents for treatment, the medical records for that patient are pulled and given to the doctor. After each visit, the patient's medical records are refiled. On or about March 16, 1986, pursuant to a subpoena from the Department of Professional Regulation, Koo provided the original medical records on ten (10) abortion patients. These original medical records were examined by John F. McCarthy, a questioned documents expert for the Florida Department of Law Enforcement. McCarthy's examination by electrostatic detection apparatus revealed that numerous indentations on the records superimposed with information from other records. For example, Exhibit 6 contained indentations from the writing on the face of Exhibit 10. Further, McCarthy found indentations on Exhibit 6 resulting from the writing on Exhibit 8. Thus, Exhibit 8 was on top of Exhibit 6 when it was prepared. Exhibit 8, however, is dated July 24, 1985, and Exhibit 6 is dated May 29, 1985. McCarthy's expert opinion is that at the time the various documents were prepared, they were on top of each other. It is therefore found that Exhibits 1-10, the original medical records on the ten named abortion patients, were not prepared at the time Koo saw the patients, but were instead all prepared at the same time, in response to the subpoena. It therefore must be found that the records were fabricated by Koo in response to the Department's subpoena. Prior to performing an abortion, a physician needs to verify whether the patient has Rh positive or negative blood type. The physician cannot rely on patients' representations that the Rh factor is positive or negative, but most obtain independent verification. This is because patients know that if they have Rh negative blood, they must receive a shot which is expensive. Koo relied on the patients' statements in ascertaining the Rh factor and did not obtain independent verification. In Dr. Rosin's expert opinion, the failure of a physician to obtain independent verification of the Rh factor poses a potential for harm to the patient and such failure is a failure to practice medicine with that level of care, skill, and treatment that is recognized in the medical community.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Medicine enter a Final Order finding Dong Hack Koo, M.D., GUILTY of violating Counts Two, Three, Four, Five, and Six of the Amended Administrative Complaint, and therein SUSPEND his license to practice medicine for a period of six (6) months during which he be required to successfully complete continuing education courses in maintaining, controlling, dispensing, labeling, and inventorying controlled substance, and in maintaining adequate patient records to justify the course of treatment. DONE AND ENTERED this 26th day of August, 1987, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-1066 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on the proposed findings of fact submitted by the parties in this case. Specific Rulings on Proposed Findings of Fact Submitted by Petitioner, Department of Professional Regulation Each of the following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parenthesis is the Finding of Fact which so adopts the proposed finding of fact: 1 (1) ; 2 (2); 3 (3); 4 (4); 5 (4); 6 (4); 7 (4); 8 (5); 9 (6); 10 (6); 11 (9); 12 (7); 13 (8); 14 (9); 15 (10); 16 (11); 17 (11); 18 (12); 19 (13); 20 (13); 21 (15); 22 (14); 23 (14); 24 (16); 25 (16); 26 (16); 27 (16); 28 (17); 29 (18); and 30 (19) That portion of proposed finding of fact 12 which concludes that Respondent does not maintain emergency equipment in his office is rejected as unsupported by the competent substantial evidence. COPIES FURNISHED: Ray Shope, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Dong Hack Koo, M.D. 121 East 8th Street, Suite 7 Jacksonville, Florida 32206 Dorothy Faircloth, Executive DIRECTOR Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joseph A. Sole, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
