Findings Of Fact The Respondent, Joya L. Schoen, graduated from medical school in 1966. Dr. Schoen is board eligible in psychiatry. T. 195-96. She had three years residency in general psychiatry and a two year fellowship in child psychiatry. From 1967 to about 1979, she practiced in psychiatry. Dr. Schoen has been licensed by the State of Florida since 1973. The Respondent's father was a physician, and in 1979, she began to take over his practice in general medicine. The Respondent took about three years to discontinue her psychiatric practice and assume her father's general practice. T. 196. On June 14, 1985, a patient, who will identified by her initials, K. H., was referred to Dr. Schoen by another physician, Dr. Mengel. T. 197. Her symptoms were an inability to concentrate, "spaciness," pervasive fatigue, P.M.S. (premenstrual syndrome), and irregular-periods. Her symptoms were aggravated by certain foods, fumes, and perfumes. T. 217. K. H. had discovered that dairy foods and foods containing high- carbohydrates aggravated her condition, and she was then avoiding them in her diet. T. 218. K. H. had already been seen by a Dr. Mengel, and he had recommended that she receive allergy testing. T. 198. Dr. Schoen had K. H. take the RAST I.G.E. test. T. 217. The RAST I.G.E. test is a screening test to determine, in a general sense, whether a patient has allergies. T. 216; (Supplemental Transcript, ST) ST-14. The degree of allergy is related to the score. A score over a hundred is considered a positive indication of the presence of allergies. T. 217. K. H.'s score on the RAST I.G.E. test was 1,993, T. 85, which was an extraordinarily high level, T. 88-89, indicating a probability of a high degree of allergy. T. 217, ST-14. The RAST test, like the cytotoxic test, is performed on blood samples, and thus is not traumatic to the patient. T. 222. All witnesses viewed this test as an acceptable test. Dr. Schoen also did a general screening for allergies, and determined that environmental allergies were not very high. T. 218. That left food allergies to be investigated. Id. Cytotoxic testing tests for food allergies, or more precisely, for adverse reaction of white blood cells to foods. T. 218, 233. The cytotoxic test confronts samples of the patient's blood with certain foods. The reaction of the leukocytes in the patient's blood is observed. ST-12; T. 47. Foods which cause reactions are then selectively removed from the patient's diet, and the increase or decrease of the allergy is observed. In this way, by trial and error, it is hoped that the particularly food to which the patient is allergic will be identified. Cytotoxic testing was available in 1985, and had been available since at least 1979. Approximately ten thousand cytotoxic tests were conducted from 1979 to 1986 by the laboratory that performed the cytotoxic test for Dr. Schoen for K. H. T. 158. Hundreds of physicians ordered cytotoxic testing from this laboratory; some physicians ordered it repetitively. T. 171. See also T. 101. The users of the cytotoxic test were primarily medical doctors, but were also doctors of osteopathy, chiropractors, and dentists. T. 172-73. The laboratory ceased performing the test in 1986 due to increasing questions concerning the efficacy and reliability of the test and the advent of better tests. T. 165-67. A large number of physicians have used the cytotoxic test at one time or another. ST-12; T. 172-73. Dr. Schoen traveled to Washington, D. C., to learn more about cytotoxic testing. T. 234. She also discussed the utility of the test with another physician. T. 233. Dr. Schoen has used the cytotoxic test about forty or fifty times; in some cases the test has led to marked improvement in the patient's condition, and in other cases, the test has not been helpful. T. 219. She was not aware of any patient having been harmed by use of the test. T. 221. Cytotoxic testing for food allergies ordinarily was less expensive than skin testing. T. 190-92. In August, 1983, the Health Care Financing Administration, United States Department of Health and Human Services, issued in the Federal Register a notice that cytotoxic testing would not be reimbursed by that agency under Medicare coverage. P. Ex. 3. The notice in the Federal Register noted that "there was a wide range of conflicting views regarding the efficacy of cytotoxic food testing ..." P. Ex. 3, p. 37717. The article discusses a number of evaluations of the test, some favorable to the test, and many unfavorable. Cytotoxic testing is a subjective test, T. 47, and is considered by some physicians to be experimental and useful only in research. T. 50. Nonetheless, as discussed above, a large number of physicians disagreed, and used the test in their practice from 1979 through 1985. Since 1985, other tests have come along that are more reliable than the cytotoxic test, and the cytotoxic test is no longer given. T. 220-21. Currently, Dr. Schoen does not use the cytotoxic test, but uses tests like the RAST test in part because it is covered by insurance, and cytotoxic testing is not. (The other reason is that the laboratory that performed cytotoxic testing for Dr. Schoen has discontinued the test.) T. 222. When she arrived at Dr. Schoen's office, K. H. had read The Yeast Connection by William G. Crook, M.D. (R. Ex. 1), and asked Dr. Schoen to give her a cytotoxic test. T. 197-98. K. H. had concluded that she preferred the cytotoxic test because she thought it would be less stressful than other allergy tests. T. 198. She also wanted to be given treatment with the drug Nystatin in hopes that she could avoid shots, desensitization, and a long and expensive process of allergy treatments. T. 199. It is inferred that K. H. was fully aware that the diagnosis of systemic candidiasis and treatment by Nystatin as described by Dr. Crook was a new theory. This inference is based upon the fact that she had been to several physicians, none of whom turned to Dr. Crook's theory, and that she was familiar with Dr. Crook's book. T. 198-99. It is evident from Dr. Crook's book, which is entitled in part "A Medical Breakthrough," and in the first few pages communicates an awareness that the theory is quite new and still not' accepted by mainstream medicine. R. Ex. 1. This finding of fact is further corroborated by the affidavit of K. H. R. Ex. 8. Dr. Schoen gave K. H. reading material about cytotoxic testing and discussed with K. H. the nature of the cytotoxic test and the alternative procedures that were available, that is, to be referred to a physician who specialized in allergies, and to undergo allergy testing by skin testing using needles and shots. See T. 25, 199. This finding is corroborated by the affidavit of K. H., wherein K. H. states that Dr. Schoen explained to K. H. that cytotoxic testing was accepted by only a minority of physicians. R. Ex. 8. K. H. said that she was terrified of needles, and was so allergic to so many things that such testing might make her worse. K. H. wanted to try cytotoxic testing and treatment with Nystatin before trying testing by an allergist. T. 202, 236. K. H. understood that the cytotoxic test was an out-of-the-mainstream test and was perhaps not proven. T. 199; R. Ex. 8. Dr. Schoen's written records of treatment of K. H. do not show consent of K. H. to take the cytotoxic test, or advice to K. H. by Dr. Schoen that the test was experimental and that other alternatives existed. T. 54. Dr. Schoen did not make a written record of her advice to K. H. concerning the cytotoxic test, or of K. H.'s understanding of the nature of the test. The affidavit of K. H., R. Ex. 8, constitutes after-the-fact written evidence of such explanation by Dr. Schoen and consent and understanding by K. H. Failure to obtain written consent from K. H. prior to cytotoxic testing had no adverse effect or potential adverse effect to the health of K. H. T. 68. Dr. Schoen directed that K. H. be given a cytotoxic test. T. 218. Dr. Schoen diagnosed K. H.'s condition as allergies and systemic candidiasis. T. 218. Dr. Schoen prescribed treatment with Nystatin and a diet that avoided yeasty foods, such as dairy foods and foods containing high carbohydrates. T. 218. K. H. took Nystatin as prescribed by Dr. Schoen from June, 1985, to November, 1985. This is the course of treatment recommended by William. G. Crook, M.D., for systemic candidiasis. Id. Dr. Schoen told K. H. that Nystatin is usually given to treat candidiasis, and that the drug is virtually nontoxic and safe. She also told K. H. that Nystatin was not something a regular physician would prescribe for her condition, but that it was widely used among physicians that she knew with safe results. T. 201. This finding is corroborated by the affidavit of K. H. R. Ex. 8. Nystatin is one of the safest drugs available to physicians today, having no serious side effects. ST-9. It is well-tolerated by patients. T. 45. Nystatin is an antifungal medicine that is frequently used to treat localized candidiasis. The alternative course of testing and treatment by an allergist would perhaps take one to three years, and would ultimately be quite a bit more expensive than the testing and treatment selected by Dr. Schoen, due to the need in such alternative treatment for numerous physician visits and shots. T. 203- 04. This finding of fact is corroborated by the medical report of Elmer M. Cranton, M.D. R. Ex. 7, p. 2. Some maladies are difficult to diagnose, but may be diagnosed through trial therapy. Trial therapy is a course of nontoxic therapy without a specific diagnosis. If health improves during such therapy, it is concluded that the patient had the disease treatable by such therapy. T. 200, 205. It is not uncommon in medicine for a physician to prescribe a course of treatment that in fact works to either cure the malady or relieve the symptoms, but no one understands scientifically why it works. T. 205-06. This finding of fact is corroborated by R. Ex. 6, attachment: "`Think Yeast'--The Expanding Spectrum of Candidiasis," reprinted by "The Journal of the South Carolina Medical Association," and by R. Ex. 1, "A Special Message for the Physician," p. 2. The diagnosis of systemic candidiasis cannot be tested by conventional scientific tests. This finding of fact is corroborated by R. Ex. 4, p. 10. It may take many months, or a year or two years, for a patient to respond to Nystatin treatment. Dr. Schoen saw no significant improvement in K. H. from June, 1985, to November, 1985, when she was her patient. T. 236. K. H. had psychological problems when she visited Dr. Schoen. Dr. Schoen was aware that K. H. had psychological problems, but determined that she deserved a chance to receive the treatment Dr. Schoen selected because it was not harmful, and might be of help to her in her case. T. 201. Dr. Schoen assessed K. H.'s circumstances and determined that medical treatment should be attempted first, and that psychological treatment was then not appropriate. Her conclusion was based upon her observation that due to K. H.'s symptoms (irregular memory, spaciness, and fatigue), K. H. would not be capable of participating in psychological therapy. She also noted the dysfunctional condition of her parents as an additional reason that psychological treatment was not appropriate at that time. T. 202-04. Finally, K. H. was a newly converted fundamentalist Christian, and had turned to religion for emotional help. She had psychological counseling suggested to her, but apparently did not follow up on the suggestion. Under these circumstances, Dr. Schoen concluded that psychological counseling was not possible at that-time. T. 238. Dr. Schoen did not discuss these conclusions with K. H. There is no evidence that she should have discussed these conclusions with K. H. Dr. Robert M. Stroud graduated from medical school in 1956, and is licensed to practice in Florida, Alabama, and North Carolina, and is board certified in internal medicine, allergy, immunology, and rheumatology. His board certification in immunology was in 1974. Dr. Stroud practices in Ormond Beach, Florida, and specializes in allergy and rheumatology, ST-4,6. Allergy is a subspecialty of internal medicine. ST-15. He was a professor of medicine at the University of Alabama for 14 years, teaching medicine, microbiology, and immunology. ST-3. He has been a clinical professor at the University of Florida since 1982. ST-4, 6. Dr. Stroud was accepted as an expert in medicine, allergy, and immunology. ST-7. Dr. Stroud uses the diagnosis "yeast allergy" or candida allergy" in his practice, and by that diagnosis, means the same thing as systemic candidiasis. ST-7. He views the condition as an allergic reaction to yeast on the surface of membranes. Id. When Dr. Stroud makes the diagnosis of yeast allergy, or if he strongly suspects that diagnosis, the treatment he prescribes is a yeast elimination diet and Nystatin administered orally. ST-9. Dr. Schoen discussed K. H.'s case with Dr. Crook, and Dr. Crook told Dr. Schoen that he agreed with her diagnosis and course of treatment. T. 206- 11; R. Ex. 6. Dr. Schoen also discussed K. H.'s case with Elmer Cranton, M.D., and Dr. Cranton told Dr. Schoen that he agreed with her diagnosis and course of treatment. T. 211-15; R. Ex. 7. (Both of these findings of fact find that Dr. Schoen was in fact told this by both physicians. To the extent that the opinions of these two physicians are offered for the truth of the opinions, the evidence is hearsay, but is corroborative of the finding of fact which follows.) The diagnosis of systemic candidiasis, or yeast allergy, as used by Dr. Stroud, is used by a thousand or more physicians in this country who practice internal medicine, osteopathy, and allergy medicine, and the number has been growing rather than diminishing. ST-10, 16-17. Serious research continues in this field, and a large number of physicians in the country have seriously investigated the possible link between candida and the immune system. ST-11. A substantial minority of physicians in Florida and in other states agree with the theories of diagnosis and treatment of Dr. Crook in The Yeast Connection, and believe that systemic candidiasis is a medically proper diagnosis. T. 225, 228- 30, and the testimony of Dr. Stroud. This finding of fact is corroborated by R. Exs. 2, 6 (attachments), and 7, and T. 206-15. The American Academy of Allergy has issued position papers disapproving the diagnosis of systemic candidiasis and cytotoxic testing, and calling them experimental. P. Ex. 2. 45. Dr. James E. Quinn is a medical doctor and has practiced family medicine in Sanford, Florida, for 11 years. He has been board certified in family practice for the last 8 years. T. 10. On about November 26, 1985, K. H. came to Dr. Quinn for treatment. Her sister and brother-in-law were concerned about the treatment she was receiving from Dr. Schoen, and told Dr. Quinn that the family felt that K. H. actually had an emotional problem. T. 10. K. H. complained that she was being poisoned by the environment around her, by chemicals, by perfumes, and by foods. T. 11. She could not tolerate certain foods, would become confused when near perfume, and her period was irregular. T. 12. She was chronically fatigued. T. 12. K. H. was examined by Dr. Quinn. Dr. Quinn diagnosed the existence of a severe emotional problem, but found no evidence of a typical amount of allergic disease. T. 11. In Dr. Quinn's opinion, systemic candidiasis occurs only in association with severe illnesses in a general hospital setting, such as certain carcinoma, leukemia, AIDS, after chemotherapy, or after sustained use of antibiotics. T. 12-13, 22. This form of candidiasis occurs in identifiable areas, such as the esophagus, the bladder, or other systems. T. 22. Dr. Quinn was of the opinion that it would be proper to treat this form of systemic candidiasis with an infectious disease medication and with an antifungal agent such as Nystatin. T. 23-24. Dr. Quinn had no familiarity with the concept of systemic candidiasis as set forth by Dr. Crook. T. 26. Dr. Quinn had no personal experience with cytotoxic testing. T. 25. Dr. Quinn saw K. H. only once, T. 19, and did not review Dr. Schoen's records for K. H. T. 26. Dr. Quinn referred K. H. to a psychiatrist, Dr. Moises, for mental health evaluation, and referred K. H. to an allergist, Dr. Alidena, for an allergy evaluation. T. 13-14. Dr. Alidena felt that K. H. possibly had mild food allergies. T. 18. She recommended a food elimination diet and wait for the psychiatric report. Id. Dr. Eugene F. Schwartz is a medical doctor who has been in private practice specializing in adult and pediatric allergy and immunology since August, 1983, in Altamonte Springs, Florida. T. 28, 30. He is board certified in pediatrics and allergy and immunology. T. 29. He is a member of the American Academy of Allergy and Immunology, an organization composed of the largest number of board certified allergists and immunologists in the country. T. 41, 104. Dr. Schwartz agreed with Dr. Quinn that systemic candidiasis occurred in certain severely debilitated patients, such as those with cancer, or having immune suppression problems. T. 37. Dr. Schwartz was of the opinion that systemic candidiasis as described by Dr. Crook was not an appropriate diagnosis, and thus that prescription of Nystatin for such a diagnosis was inappropriate because the diagnosis "did not exist." T. 39-40. Dr. Schwartz had two methods of diagnosing patients who thought that they had systemic candidiasis after reading Dr. Crook's book: to either find another cause of the problems or to advise the patient that he (Dr. Schwartz) did not know what the cause of the problem was. T. 40, 44. If a patient came in complaining of adverse reactions after eating certain foods, Dr. Schwartz would have prescribed a skin test for food allergies. T. 48. Dr. Schwartz was of the opinion that the cytotoxic test was spurious and "quite experimental," and should be limited to research projects. T. 50. Dr. Schwartz was of the opinion that Dr. Schoen's practice with respect to diagnosis of K. H. as having systemic candidiasis was "outside the mainstream of medicine, that other prudent, physicians would not have done so." T. 65. He was also of the opinion that prescription of Nystatin was not proper, that use of cytotoxic testing was not proper, and that lack of written informed consent to the cytotoxic test was not proper. T. 66-67. Dr. Schwartz believed that a minority of physicians thought that the diagnosis of systemic candidiasis is a proper diagnosis. T. 109. Dr. Schwartz stated that Dr. Crook is one of the leading authorities with respect to the diagnosis of systemic candidiasis and treatment by use of Nystatin, T. 70, and agreed that there have been other articles supportive of Dr. Crook's Views. Id. Dr. Schwartz testified that the symptoms that K. H. presented to Dr. Schoen met the criteria for Dr. Crook's diagnosis of systemic candidiasis. T. Dr. Schwartz also agreed that if the diagnosis of systemic candidiasis was proper, Dr. Schoen did prescribe the proper treatment as recommended by Dr. Crook, and that her prescription of Nystatin was proper as recommended by Dr. Crook. T. 42, 81. Dr. Schwartz also conceded that a minority of physicians used cytotoxic testing to determine the presence of allergies to various given substances. T. 110. Dr. Joseph Akerman has been in the general practice of medicine since 1952 in Apopka, Florida. He is board eligible in family practice medicine. T. 120. He was accepted as an expert witness in the practice of medicine, including the standard of care for general medical practitioners and family practitioners in the Orlando area. T. 122. Dr. Akerman had never seen a case of systemic candidiasis. T. 124. Dr. Akerman would not use that diagnosis in his own practice, nor would he use the course of treatment prescribed by Dr. Crook. T. 124, 130. He was not familiar with any physicians who subscribed to Dr. Crook's theories. T. 131. Dr. Akerman personally disagreed with Dr. Crook's theories. T. 130. If Dr. Crook's theory of systemic candidiasis were correct, Dr. Schoen's diagnosis of systemic candidiasis in the case of K. H. was correct, in Dr. Akerman's opinion. T. 130. On December 31, 1987, the Respondent filed a motion to dismiss the administrative complaint. The motion raised two issues: whether the probable cause panel considered some evidence that the violations alleged occurred, and whether the probable cause panel was composed of three members as required by law. Attached to the motion was a transcript from that portion of the meeting of the probable cause panel that considered the charges against the Respondent. That transcript was admitted into evidence as R. Ex. 4. The probable cause panel met in Palm Beach, Florida, on August 21, 1987. Two members were present. The members present had been furnished the investigative report and a recommendation. R. Ex. 4, p. 3-5. The transcript shows who attended the meeting, but does not show the composition of the panel. The two members agreed with the administrative complaint. R. Ex. 4, p. 10-11, with one exception which apparently was deleted from the complaint. Id. at p. 10. The Petitioner submitted an affidavit concerning the composition of the probable cause panel. P. Ex. 7. The affidavit is hearsay, and cannot be relied upon to make a finding of fact as to the composition of the probable cause panel. There is no competent evidence in the record from which a finding of fact can be made that the probable cause panel in this case was composed of less than three members.
Recommendation For these reasons, it is recommended that the Department of Professional Regulation, Board of Medicine, enter its final order dismissing the administrative complaint against the Respondent. DONE and ENTERED this 26th day of September, 1988, in Tallahassee, Florida. WILLIAM C. SHERRILL, JR. 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 September, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-4351 The following are rulings upon proposed findings of fact which have either been rejected or which have been adopted by reference. The numbers used are the numbers used by the parties. Numbers have been sequentially attributed to the unnumbered paragraphs filed by the Respondent. Statements of fact contained in this appendix or adopted herein by reference are intended to be additional findings of fact. Findings of fact proposed by the Petitioner: 5. A categorical finding that the cytotoxic test was considered to be purely experimental by allergists and immunologists cannot be made in view of the fact that many physicians used the test in the years in question. The record cited does not contain evidence that Nystatin is a legend drug. Findings have been made that K. H. received this drug through prescription by Dr. Schoen. The first sentence is not supported by the record cited. The second sentence is thus not relevant. Since a substantial minority of physicians accept the diagnosis of systemic candidiasis as described by Dr. Crook, the word "only" in the first sentence is rejected. The second sentence is a true statement of the opinion of the majority of such physicians, but a substantial minority of physicians disagree. All physicians who testified agreed that K. H.'s symptoms were consistent with the diagnosis of systemic candidiasis as described by Dr. Crook. It is true that K. H. did not suffer from a severe illness of the type with which systemic candidiasis is also a potential associated diagnosis. Since systemic candidiasis as described by Dr. Crook cannot be detected by testing, the lack of the tests set forth in this proposed finding of fact is irrelevant. Diagnosis by trial therapy is a medically accepted way to proceed where testing is ineffective for diagnosis. Rejected for the reasons stated in findings of fact 11-14. Rejected for the reasons stated in findings of fact 18-25. Rejected for the reasons stated in findings of fact 30-36, 39-43, 62- 64, and 69. Findings of fact proposed by the Respondent: 1. The first sentence of this proposed finding of fact is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 3. Mr. Zavik was accepted only a- an expert in cytotoxic testing procedures. T. 164, 166, 169-70. He did not have expertise to express an opinion as to the jurisdiction of the Food and Drug Administration. The second sentence is cumulative and unnecessary. 9. The fourth sentence is cumulative and unnecessary. The sixth sentence is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 14. These proposed findings of fact are not supported by the record cited. The summary of what Dr. Godorov said is confused and ambiguous. 17. The sixth sentence is cumulative and unnecessary. The second sentence is irrelevant. The second is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 25 and 28. These proposed findings of fact are subordinate to findings of fact that have been adopted. They are true, however, and are adopted by reference. 29. The second is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 31. These proposed findings of fact are irrelevant since the summary of what Dr. Godorov said is too confused and ambiguous to be a basis for a finding of fact. COPIES FURNISHED: Robert D. Newell, Esquire Newell & Stahl, P.A. 817 North Gadsden Street Tallahassee, Florida 32303-6313 Salvatore A. Carpino, Esquire One Urban Centre, Suite 750 4830 West Kennedy Boulevard Tampa, Florida 33609 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Ms. Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is Michael D. Fox, M.D. Respondent is board certified in obstetrics and gynecology. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 66312. Respondent's address is 3627 University Boulevard, South, Suite 200, Jacksonville, Florida 32216-4211. At all times material to this complaint, Respondent provided professional services as an employee of North Florida Gynecologic Specialists in Jacksonville, Florida. On or about September 26, 2003, Patient T.D. presented to Respondent with a history of worsening pelvic pain and abnormal menstrual bleeding. On or about October 6, 2003, Respondent and Patient T.D. agreed that Patient T.D. would undergo a hysterectomy. On or about October 22, 2003, during a pre-operative examination, Respondent ordered pre-operative lab studies, including a urine pregnancy test, for Patient T.D. On or about October 27, 2003, Respondent performed a total abdominal hysterectomy on Patient T.D. During Patient T.D.'s hysterectomy, Respondent took a specimen from Patient T.D., which was sent to pathology for evaluation. On or about October 29, 2003, a microscopic examination of the surgical specimen was performed that revealed Patient T.D. was pregnant at the time Respondent performed the hysterectomy on Patient T.D. Respondent did not ascertain the correct results of Patient T.D.'s pre-operative pregnancy test prior to performing the October 27, 2003, hysterectomy on Patient T.D. Respondent's Care of Patient T.D. Respondent attended medical school at the University of Alabama, Birmingham, Alabama. He did a four-year residency in obstetrics and gynecology (ob/gyn) in Jackson, Mississippi, and a two-year sub-specialty fellowship in reproductive endochrinology in Lexington, Kentucky. He is board-certified in reproductive endochrinology and ob/gyn. At present his specialty is reproductive endochrinology. Respondent has experience in performing hysterectomies and the pre-operative evaluations associated with those surgeries. Respondent does 30 to 40 hysterectomies a year. That number represented his experience in 2003. The principal reason for performing hysterectomies in his practice, is associated with sub-specialty interests, surgery for endometriosis and adenomyosis, a co-disease with endometriosis. Respondent has privileges to practice in hospitals in the Jacksonville, Florida area. In particular, he has privileges at St. Vincent's, St. Luke's, Baptist, Baptist Beaches, Memorial and Shands hospitals. He performs surgeries in all those hospitals. The hospitals where Respondent practices have computer systems that allow access to laboratory records and other forms of information associated with patient care. Although he has access to the computer systems in the facilities, his routine is to obtain laboratory information in the hospital setting from other persons involved in the patient care. He asks those persons to find out the information for him and report the finding(s). Respondent would have access to the patient hospital record, as well as a source for obtaining laboratory information. Respondent routinely looks at the patient hospital record in preparing for surgery. Concerning Patient T.D., the subject of this proceeding, when seen by Respondent she was described as a young female, of child-bearing age who presented with chronic pain. She had pain with periods which Respondent found to be characteristic of adenomyosis. She had pre-cycle pain approximately a week prior to her menses, another characteristic of adenomyosis. The patient had irregular bleeding that is an indication of adenomyosis. The patient was found to have an enlarged uterus, the primary source of her pain on the examination. This visit with Respondent, that formed the basis for his impression, took place on September 26, 2003. On the initial visit Respondent also obtained a history consistent with endochrine disorder causing irregular cycles. In the patient's case, the cycles extended as much as 60 days in relation to her periods. Based upon his initial impression, Respondent did not find evidence that Patient T.D. was pregnant. The patient told Respondent that she had no desire for fertility. At that time, she did not report having a partner, nor did she indicate that she was sexually active. To further evaluate the Patient T.D.'s condition and complaints, Respondent ordered an ultrasound test. That study was performed on October 2, 2003, and a gynecological ultrasound report rendered. Based upon the report, Respondent held to the view that the report showed evidence of adenomyosis. There was a mild and moderate enlargement of the uterus, which Respondent found to be consistent with adenomyosis. The patient had had a prior pregnancy and delivery and Respondent found the depiction on the ultrasound of a mild enlargement of the uterus consistent with the prior pregnancy and delivery. On their next visit, Respondent discussed the choice of a hysterectomy or some other form of surgery that did not involve a hysterectomy, to treat the endometriosis and relieve her symptoms. That visit took place on October 6, 2003. On October 22, 2003, Respondent met the patient again. He reviewed the details of what he believed was the underlying disease and potential treatments in discussion with the patient. The patient indicated that she wanted to proceed with the hysterectomy. That choice having been made, the surgery was discussed between the patient and Respondent and the necessary paperwork was started to arrange for the surgery in the hospital. When preparing for surgery Respondent ordered a pregnancy test to verify whether the patient was pregnant or not. The nature of the test was a urine pregnancy test under Respondent's preoperative orders given October 22, 2003. The specimen was collected on October 22, 2003, and received by Memorial Hospital (Memorial), Jacksonville, Florida, where the hysterectomy was to be performed. The test result was positive for pregnancy. The point in time that the result was revealed to Respondent will be discussed beyond this reference to the result. On October 27, 2003, Respondent began his surgery cases at Memorial at 7:30 a.m. On that date there was no indication in the patient record or chart maintained in his office practice that reflected information concerning the pregnancy test result, nor was that information found in the hospital chart related to Patient T.D. Absent the information, Respondent testified that he asked the circulating nurse at Memorial about the result of the pregnancy test. That was Tracy Lloyd, R.N. According to Respondent, the nurse went away to check the result and as Respondent describes "subsequently told me it was negative." No further effort was made by Respondent to confirm the oral report that Respondent says was made by the nurse. Respondent did not document the results of Patient T.D.'s pre-operative pregnancy test in the medical record. It was not his habit to write that type of a pre-operative note. Respondent testified that Ms. Lloyd told him about the pregnancy test results while in the holding area in the presence of the patient. Respondent commented that his question to the nurse would have been "What are the results of the pregnancy test?"1/ Aside from the results of the pregnancy test, nothing in the patient's condition, known to Respondent, led him to believe that the patient was pregnant. When the laparoscopic surgery commenced, Respondent did not perform an examination of the patient under anesthesia, given his recent examination of the patient in his office and the results of the ultrasound. Moreover, Respondent does not believe that such an examination under anesthesia would reveal anything other than the adenomyosis and the endometriosis which conformed to his preoperative diagnosis. On that subject, the later examination of the specimen on October 29, 2003, revealed that Patient T.D. had an early pregnancy, estimated as 4 to 5 weeks. In Respondent's opinion, in a 4-to 5-week pregnancy, the uterus would not normally achieve the size of a uterus that was reported on the ultrasound as mildly enlarged, not pregnant. Mildly enlarged refers to a 6 to 8 weeks' pregnancy. Respondent expected to see an enlarged uterus because of the adenomyosis which could be anticipated to cause an inflammatory response in the wall of the uterus, softening the uterus and giving it an appearance that would be similar to an early pregnancy. The rounded globular description of the findings during surgery were consistent with the expectations in addressing cases involving adenomyosis, according to Respondent. Returning to the surgical specimen obtained in Patient T.D.'s case, it was examined through surgical pathology conducted by Robert E. Barnes, M.D. A report was rendered. The report explains that in the examination of the specimen, the endometrium, "gestational endometrium with products of conception" were present. This was the finding related to Patient T.D.'s pregnancy. Dr. Barnes, is a board-certified pathologist in anatomic and clinical pathology. He describes his findings pertaining to Patient T.D., the gestational endometrium with products of conception, as referring to an early embryo, the endometrium showing changes associated with pregnancy. In his opinion the pregnancy was between 10 and 16 days following conception. When Dr. Barnes contacted Respondent on October 29, 2003, to advise of his findings in the pathology. It was a brief conversation and he does not recall the details. After the revelation concerning the pathology, Respondent's office staff found the information concerning the results of the urine pregnancy test in the hospital chart retained in the computer at Memorial. This finding was made around November 4, 2003. In a section within the report on the pregnancy test it refers to the "Result" and underneath that, the word "POSITIVE" is entered referring to pregnancy. When it was discovered that the hysterectomy had been performed while the Patient T.D. was pregnant, at her post- surgery scheduled office visit, a discussion was held with the patient concerning the "checks and balances" in place to avoid the problem. That refers to the surgery at a time the patient was pregnant. Respondent talked to the patient about counseling, or something similar, given the outcome in the case. As a result of the error, steps were taken within Memorial to address this circumstance. The Respondent and the Memorial Department of OB/GYN made changes, by requiring a pre- operative pregnancy test as protocol, that established a urine pregnancy test within 72 hours of surgery. That test would be performed by the nurses in the holding area. Respondent now orders a blood pregnancy test which is a more sensitive test to determine pregnancy. Expert Opinion Jose Cortes, M.D., is board-certified in ob/gyn, licensed to practice in Florida. He was recognized as a expert in ob/gyn for purposes of expressing his opinion about the care Respondent provided Patient T.D. Dr. Cortes has done hysterectomies in his practice, as recent as June 2006. He was called upon to render an opinion concerning the care Respondent provided Patient T.D. involving her hysterectomy. He had access to material concerning her care involved with this case. Dr. Cortes' impression of Respondent's medical treatment of the patient in the beginning, was that it was adequate and correct, with the proper evaluation performed and an appropriate decision made for surgery. Dr. Cortes expressed the opinion that in performing a hysterectomy on a woman who is of child-bearing age, which Patient T.D. was, a physician should order a pre-operative pregnancy test. In reviewing Patient T.D.'s records Dr. Cortes did not find a record documenting that the pregnancy test was ascertained by Respondent, referring to the test results. In his experience the results of the preoperative tests would be reflected in the patient's medical records as a matter of custom. Respondent, according to Dr. Cortes, could have obtained the results of the pre-operative pregnancy test for Patient T.D. by a fax to his office, a copy obtained through a computer, laboratory printouts sent to Respondent's office, and a copy of the pre-operative laboratory results obtained by the hospital placed in its medical record. Dr. Cortes stated the position that an experienced ob/gyn, and Respondent fits that category, could reasonably be expected to rely upon an oral report from a nurse as to the results of the pregnancy test, before entering the operating room, in the area of the pre-operative alcove as the patient is being interviewed by the physician. Dr. Cortes goes on to explain that if the conversation with the nurse in the presence of the patient was in the operating room holding area, then the pregnancy test results would have to have been documented in the patient chart to find the oral report acceptable. Those test results as reported would have had to be entered by the physician in the patient chart to meet the standard of care upon the oral report.2/ Later on, Dr. Cortes in his testimony seems to subscribe to the view that an oral report by the nurse as to the pregnancy test results would meet the standard of care, assuming that the Respondent in this case was provided an oral report. In the testimony at hearing, Dr. Cortes also said that obtaining an oral report or verbal report on test results, in an emergency situation, would meet the standard of care. By contrast, in elective surgery, such as that being performed on Patient T.D., it would be such that there was ample time to review a chart and laboratory studies before the patient was brought into the surgical suite. Generally stated, Dr. Cortes accepts that physicians frequently rely upon oral information imparted by nurses in performing surgeries, be they elective or emergent, but without an oral report this concession is not important. Regardless of the pre-conditions for Respondent to receive and rely on an oral report of the results of the pregnancy test, without an oral report, there being no other basis for Respondent's knowledge of the pregnancy test results, it was below standards to proceed with the hysterectomy. This view is taken from Dr. Cortes' testimony. Dr. Cortes expressed the opinion that it was below the standard of care to not ascertain the results of the patient's pre-operative pregnancy test prior to performing a non-emergent hysterectomy, that is an elective hysterectomy. Dr. Cortes expressed the opinion that it was below the standard of care for Respondent to perform a hysterectomy on Patient T.D. while she was pregnant in an elective setting. In addition to the results of the pregnancy test, Dr. Cortes believes that Respondent had other opportunities to detect the pregnancy, including an examination of the patient while she was under anesthesia during the surgery, and would have allowed a comparison of the results at the time of surgery against previous examinations that Respondent had performed on the patient. In referring to the previous examinations compared to an examination under anesthesia, this included the results of the ultrasound performed on October 2, 2003. Dr. Cortes does agree that the underlying condition visualized under anesthesia could be associated with prior pregnancy or the pre-operative diagnosis of adenomyosis. Dr. Cortes believes that Respondent's medical records, in the context of what could have been found upon an examination under anesthesia during the surgery, could be consistent with a possible pregnancy. A change seen in the pelvic examination at surgery would create an opportunity to evaluate and raise in the Respondent's mind any doubt concerning pregnancy. A slight increase in the size of the uterus between September 26, 2003, and October 27, 2003, is what is being referred to, promoting clinical judgment about possible pregnancy. Bryan Cowen, M.D. specializes in ob/gyn and reproductive endochrinology. He practices at the University of Mississippi in Jackson, Mississippi. He is a professor and chair in the Department of OB/GYN and has been for five years. He has been affiliated with the University of Mississippi for 24 years. He did his undergraduate work at the University of Colorado in Boulder, Colorado, and attended medical school in Denver, Colorado. Dr. Cowen is licensed to practice medicine in Mississippi and is board-certified. Dr. Cowen has performed a number of hysterectomies during his career. Dr. Cowen is familiar with the standard of care applicable for physicians such as Respondent, in the evaluation of patients suspected of endometriosis and adenomyosis and the considerations for treatment by hysterectomy. He is also familiar with the standard of care in relation to pre-operative testing and the associated duties of physicians when ordering such tests. In preparing to testify in this case, Dr. Cowen examined the Memorial medical records, Respondent's office records, and the depositions of Respondent, Dr. Freeman, Dr. Widrich, Dr. Barnes, and Dr. Cortes. With this information in mind, Dr. Cowen was able to provide an opinion concerning the standard of care in relation to the treatment provided by Respondent to Patient T.D. That opinion was that Respondent did not breach the standard of care in that he met due diligence in the process by the pre-operative laboratory-ordered, and pre- operative evaluation and assessment. Speaking to the September 26, 2003, office visit, Dr. Cowen saw nothing on the physical examination to indicate to him that Patient T.D. was pregnant. Concerning the ultrasound that was conducted on October 2, 2003, Dr. Cowen's opinion is that Respondent's assessment that Patient T.D. had adenomyosis based upon presentation, was confirmed by the ultrasound, the overall impression being that the Patient T.D. was not pregnant at that time. The further visit by the patient prior to the hysterectomy did not reveal anything in the history or physical examination that would suggest that Patient T.D. was pregnant, according to Dr. Cowen. On October 22, 2003, the pregnancy test was ordered by Respondent. The arrangement of ordering the test, sending the patient for pre-operative evaluation and laboratory tests is a common practice in Dr. Cowen's experience. In the instance where Respondent did not get a call from the pre-admission testing as to any abnormal results in the pregnancy test, and no report reflecting in the patient chart that the results were normal, Dr. Cowen commented on the need to check the laboratory results before taking the patient into the operating room. Based on Dr. Cowen's experience, there was no necessity to personally lay eyes on the test results to ascertain those results. He recognizes that his hospital may be different from Memorial in its expectations but he believes that Respondent followed Memorial's policy in accepting the report of a nurse as to the results of the pregnancy test. Dr. Cowen's opinion relies upon the factual predicate that Respondent was told by a nurse that the pregnancy test was negative, to the extent that is not true, and it has not been found as a fact, his opinion is without foundation. Further, Dr. Cowen believes that in the setting where surgery is being performed in other than an emergency, it is a sufficient practice to rely upon an oral report of a nurse concerning laboratory results, such as the outcome in the pregnancy test for Patient T.D. In his experience he has relied upon nurses to report both in an emergent and non-emergent settings. He goes on to describe how those reports come back to the medical records and the physician signs off, which did not occur in this case. Dr. Cowen was asked to express his opinion about the value of an examination under anesthesia as an assist to understanding the underlying condition of the Patient T.D. Dr. Cowen does not believe that this would provide additional information. In his experience most physicians have abandoned examinations under anesthesia. If a better insight is needed an ultrasound is the best choice. To Dr. Cowen, an examination under anesthesia does not relate to standard of care, it is in relation to an individual practitioner's protocol. An ultrasound used in this case, a transvaginal ultrasound, may have shown the gestational sack at the time of the hysterectomy but proceeding on the basis that a negative pregnancy test had been established and other findings during the course of the operation, as well as the preoperative record, would not indicate the necessity for an ultrasound in this case, at that time, the place in time where the hysterectomy was being performed. Dr. Cowen did not find anything in the intra-operative findings that would suggest to Respondent that the Patient T.D. was pregnant. Overall Dr. Cowen believes that Respondent met the standard of care in addressing the case of Patient T.D., who probably had polycystic ovarian disease, irregular cycles, was without a sexual partner by history, used condoms for contraception, had an ultrasound that confirmed a slightly enlarged uterus and had symptoms compatible with adenomyosis or endometriosis. Respondent discussed the treatment options, made an appropriate pre-operative evaluation, learned that the lab results for pregnancy were negative (an erroneous assumption), and therefore, he met the standard of care, according to Dr. Cowen. Ultimately, Dr. Cowen believes that it is essential to determine whether a patient is pregnant prior to performing a non-emergent/elective hysterectomy, which was not done here. Wyatt McNeill, M.D., testified. He is an ob/gyn practicing in Jacksonville, Florida, who in the past has had privileges at Memorial. He has performed hysterectomies at that facility. Dr. McNeill graduated from Florida State University. He graduated from the University of Miami Medical School. He is licensed in the state of Florida and is board-certified in ob/gyn. Dr. McNeill is familiar with the standard of care in relation to preoperative laboratory work done before a hysterectomy. Dr. McNeill is familiar with the standard of care applicable to Respondent in the evaluation of Patient T.D. for hysterectomy, knowing after the fact that the patient was found to be pregnant. To familiarize himself with the facts of this case, Dr. McNeill examined the hospital records of Memorial, Respondent's office records, various depositions, to include that of Dr. Cortes and the anesthesiologist and pathologist, before providing testimony. He also examined the testimony of the nurses involved in the care before offering his opinions. Concerning the patient history, objective and subjective evidence available, Dr. McNeill did not believe that there was anything to suggest that Patient T.D. was pregnant. In particular, Dr. McNeill comments on the history and physical done by Respondent, counseling, laboratory evaluation, and the decision beyond that to proceed with the surgery. Dr. McNeill found the ultrasound results consistent with a patient, who by history had a previous child and had the complaints expressed in the report concerning the September 26, 2003, visit with Respondent. Nothing in the ultrasound results compared to the findings in the operative report indicated to Dr. McNeill that the patient needed to be examined under anesthesia. The use of the examination under anesthesia is a training regimne for residents and students, in his experience. It has no utility beyond that application, in Dr. McNeill's opinion. Dr. McNeill believes that an oral report of the results of the pregnancy test meets the standard of care. As with others, Dr. McNeill assumes that Respondent was told the test results, which is not found. There was no further duty by Respondent to investigate those results having been told. In Dr. McNeill's opinion, the test results are either positive or negative, they are highly accurate. A negative test result means that the patient is not pregnant. No further duty is established beyond that realization, according to Dr. McNeill. In summary, there is no disagreement among the experts that Respondent is expected to ascertain the results of the preoperative pregnancy test before performing the hysterectomy and it would be inappropriate to perform the hysterectomy without those results. Respondent does not disagree with that perception. Conceptually, having considered the testimony of Respondent and the experts, it would be acceptable to proceed on an oral report, if one had been made, a report that the pregnancy test was negative.3/ Otherwise, the physical examination of the patient prior to surgery, the results of the ultrasound, and the observations intra-operatively made by Respondent did not indicate that the patient was pregnant. There was no necessity to make an examination under anesthesia. Even if made, it would not necessarily lead to the conclusion that the patient was pregnant, taking into account other information known by Respondent. Mitigation/Aggravation The outcome here was that the patient underwent a hysterectomy when she was pregnant, an adverse result. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of facts found and the conclusions, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), and imposing an administrative fine of $10,000.00, requiring Respondent to take a course on Risk Management for physicians, and issuing a letter of reprimand. DONE AND ENTERED this 22nd day of June, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 22nd day of June, 2007.
The Issue The issue in the case is whether the allegations of the Administrative Complaint are correct, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this case, the Respondent was a licensed certified nursing assistant, holding Florida license number 113243. On or about December 14, 2008, the Petitioner submitted to a drug screening urinalysis test at the request of an employer, Maxim Healthcare Services (Maxim). The sample was collected at a Maxim facility located at University Park, Florida. The Forensic Drug Testing Custody and Control Form and the urine sample collection container bear handwritten dates of December 13, 2008. At some point, the dates on the form and the container were overwritten to indicate that the sample was collected on December 14, 2008. According to the Respondent's Response to the Petitioner's Request for Admissions, the sample was collected on April 14, 2008. The Petitioner presented an expert witness who testified as to the testing procedures, including custody and storage of the urine samples to be tested. The expert witness' testimony regarding sample collection and transportation, calibration of equipment, sample storage and testing methodology, and reporting of test results, was persuasive and has been fully credited. According to the documentation presented by the Petitioner's expert witness, the sample collection container was received by the testing laboratory on December 15, 2008, with all transportation packaging and the sample container seal intact. According to the expert witness, the test for which Maxim paid, screened for ten drugs, including marijuana. According to the expert witness, the testing equipment was properly calibrated at the time the Respondent's urine sample was tested. The initial immunoassay test result indicated the presence of a recognized by-product of marijuana (delta nine tetrahydrocannabinol carboxylic acid) in the Respondent's urine sample. Because the first result was positive, a second test was performed using a gas chromatography/mass spectrometry device, which confirmed the presence of delta nine tetrahydrocannabinol carboxylic acid in the Respondent's urine sample. The Respondent denied using marijuana. The Respondent asserted that the test results were inaccurate. The Respondent testified that he had a prescription for, and was taking, hydrocodone at the time he provided the urine sample for the test at issue in this proceeding, but that the test results did not indicate the presence of hydrocodone. The Respondent asserted that the test result was either the result of lab error or that the sample was not his urine. The Petitioner's expert witness testified that the screening tests purchased by Maxim included limited testing for opiates and would not have indicated the presence of hydrocodone in the Respondent's urine. Although the Respondent testified that he had been told by Maxim personnel that the test results should have revealed the presence of hydrocodone, the Respondent's testimony in this regard was uncorroborated hearsay and was insufficient to support a finding of fact. Although the Respondent asserted that the sample tested was either not his urine or was otherwise tampered with, the evidence failed to support the assertion. There was no evidence that the sample was tampered with in any manner when the sample was obtained or during transportation to the testing laboratory. There was no evidence that the seal on the sample collection container was not intact at the time the sample was provided or transported. There was no evidence that the sample was stored improperly. There was no evidence that the testing equipment was not properly calibrated or that the tests were improperly performed. The Respondent testified, without contradiction, that over the course of 20 years in nursing work both before and after the tests at issue in this proceeding, his test results have never reported the presence of marijuana.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Petitioner enter a final order assessing a fine of $250, requiring completion of an IPN evaluation, and imposing a 12-month period of probation. DONE AND ENTERED this 31st day of March, 2009, 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 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of March, 2009. COPIES FURNISHED: Dr. Ana M. Viamonte Ros, Secretary State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701 Rick Garcia, MS, RN, CCM Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399-1701 Patricia Dittman, Ph.D(C), RN, CDE Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Megan M. Blancho, Esquire Carla Schell, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Michael N. Heimur, C.N.A. 4901 South Salford Boulevard North Port, Florida 34287
