The Issue The issues are whether Respondent is guilty of violations of Section 458.331(1)(k), (m), and (t) in the practice of medicine and, if so, what penalty the Board of Medicine should impose.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0033129. His license was originally issued on August 2, 1978, and remains current. There is no prior discipline against Respondent. Respondent has been certified for over 15 years by the American Board of Obstetrics and Gynecology. His practice has been devoted to obstetrics and gynecology. In 1990, Respondent was a member of a large group practicing obstetrics and gynecology in Cape Coral. Respondent was performing about 100 breast examinations a week. On the evening of April 10, 1990, D.W., who was 30 years old at the time, discovered a mass that felt like a marble in her right breast during a breast self-examination. She was upset and cried most of the night, fearful that she had breast cancer. Early the next morning, she made an appointment with Respondent's group for a breast examination later that day. A regular patient of another member of Respondent's group, who was unavailable on April 11, D. W. had last been seen by a member of Respondent's group on February 6, 1990, when her regular physician gave her an annual examination. Her breast examination at the time was normal. During the visit, the physician or nurse reviewed breast self-examination techniques with her. The physician started D. W. on birth control pills and directed her to return for a follow-up visit in two months. The April 11 office visit was devoted exclusively to addressing D. W.'s complaint of a lump in her breast. Respondent examined D. W.'s breasts with D. W. lying down and then sitting up. He felt nothing. While sitting up, D.W. guided Respondent's hand to the mass in the right breast. Still feeling nothing, Respondent remarked that the breast was somewhat fibrous. Respondent explained to D. W. that fibrocystic disease is something that women sometimes get in their breasts and it is nothing to worry about. In fact, at least 80 percent of all women in their 30s undergo fibrocystic changes in the breast. Respondent did not reach a specific diagnosis as a result of the April 11 office visit. The handwritten entries in Respondent's medical records--the complaint and blood pressure appearing to have been written by a nurse--read in their entirety: 4-11-90 Pt. c/o lump in R breast. BP--100/60 no mass found somewhat fibrous [Respondent's initials] Respondent did not advise D. W. to return to the office for a follow-up visit at a prescribed interval or if she detected the same mass or any changes in the mass. D. W. next visited Respondent's group on April 11, 1991, for her annual visit. She was seen by another physician in the group. D. W. told the physician of the lump in her breast and said that it was getting larger. The physician conducted a breast examination and felt a mass about two centimeters in diameter. Concerned about the mass, the physician scheduled an aspiration for diagnostic purposes. The results of the procedure disclosed severely atypical cells that were suspicious for carcinoma. The physician referred her to a surgeon, who first saw D.W. on May 2, 1991. The surgeon performed a breast biopsy on May 9. The biopsy revealed an infiltrating ductal carcinoma of the breast. Based on the biopsy findings, the surgeon conducted on May 17 a right modified radical mastectomy. The excised tumor measured 2.1 centimeters along its longest diameter. D. W. underwent chemotherapy and has had no recurrence of the cancer in the five years since the surgery. There are two sets of allegations concerning D.W.'s medical records. The first set of allegations is that Respondent fraudulently altered D. W.'s medical records. Someone in Respondent's office later typed the following addition to the records of D. W. immediately beneath the handwritten entry quoted above: D[.] came to the office today having felt a lump in her right breast. I could not feel anything, although her breast was somewhat fibrous. I told her to continue to check her breast and come back if she felt it again. [Respondent's initials/typist's initials-- {both typed}] Petitioner failed to prove that Respondent dictated or typed the note in the preceding paragraph or that he authorized the addition of this note to D.W.'s medical records. The intent in adding the note was fraudulent as to the third sentence, which is the only sentence in the note that is untrue. But Petitioner failed to prove that Respondent was in any way involved in the fraud. The second set of allegations concerning the medical records involves the adequacy of the records. Specifically, Petitioner alleges that Respondent failed to keep medical records justifying the course of treatment and violated the applicable standard of care by failing to keep adequate medical records. These allegations are best considered together with the remaining allegation, which is that Respondent violated the applicable standard of care by failing to recommend follow-up examinations and treatments for D. W.'s complaint of a lump in her breast. A violation of the applicable standard of care is 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. The standard of care in this case pertains to the practice in early 1990. Petitioner nowhere alleges that Respondent violated the applicable standard of care by failing to detect the mass of which D.W. complained. Petitioner's expert witness, Dr. Harvey Gardy, conceded that such a failure would not necessarily violate the standard of care. Nor is it clear that the mass of which D.W. complained in April 1990 developed into the tumor removed from her breast a year later. The mass of which D. W. complained in April 1990 was in the three o'clock position, and the excised tumor was in the 12 o'clock position. Breast tumors do not change location, except to the extent that they grow, although patients conducting self- examinations may have difficulty locating the tumor with precision. Also, the excised tumor could have grown from an impalpable size in April 1990 to its size at the time of the mastectomy a year later. The second set of medical records allegations and the lone remaining standard of care allegation focus not on Respondent's alleged failure to detect and diagnose the mass of which D. W. complained, but on Respondent's alleged failure to respond adequately to D. W.'s complaint, even after he could not independently verify the mass. The applicable standard of care did not require Respondent to order further testing at the time to rule out a cancerous growth when he could not feel the mass. D. W. was not in a high-risk category for breast cancer based on her young age, three past pregnancies, and relevant family history. She displayed no physical signs of breast cancer. The physician conducting a breast examination is looking for a dominant or distinct mass--an isolated lump distinct from surrounding breast tissue. Respondent felt only fibrous changes. The applicable standard of care did not require that a physician order further diagnostic testing each time the physician detected a fibrous mass in a breast. Fibrous changes are not indicative of breast cancer. Petitioner has failed to prove that the applicable standard of care was any different when the patient claimed to have felt a distinct mass that the physician is unable to verify. It is more practical to direct a patient to return for a follow-up examination than to order potentially expensive tests. However, Petitioner failed to prove that the applicable standard of care required that a physician, failing to detect a mass in a patient not in a high-risk category for breast cancer, direct her to return to the office at a specified interval, such as two or three months later. Even less onerous than diagnostic testing or return office visits is the physician's direction that the patient return to the office if she feels the mass again or any changes in the mass. However, Petitioner failed to prove that the applicable standard of care required even this sensible precautionary direction from a physician. Testifying unpersuasively that the standard of care required the setting of a follow-up appointment, Dr. Gardy failed to testify at all whether the standard of care required Respondent to tell D. W. to return if she detected the mass again in a self-examination. One of Respondent's expert witnesses, Dr. Pierre Bouis, testified clearly on direct that the applicable standard of care did not require Respondent to direct D. W. to return if she felt the mass again (Tr. p. 125). On cross-examination, Dr. Bouis returned to the same issue and answered affirmatively the following, poorly worded question: Now, isn't it true that you also believe that it's an appropriate standard of care to tell a patient who presents under the same set of fact that she should keep checking herself and return if she feels it again or continue to feel it? Although there are many levels of care, there is a single applicable standard of care, which, if violated, justifies the imposition of discipline. By using "an," Petitioner's counsel suggested multiple standards of care and left open the possibility that the standard to which Dr. Bouis referred in his answer was aspirational, rather than mandatory. Respondent's other expert witness, Dr. J. Kell Williams, testified clearly that Respondent's failure to direct D. W. to return if she felt the lump again did not violate the applicable standard of care (Tr. pp. 43 and 52). Dr. Williams conceded that the better practice would have been to direct the patient to return (TR. pp. 43, 46, and 47), but he did not equate this practice with the applicable standard of care. In the absence of evidence establishing this sensible precaution as the applicable standard of care, Petitioner has failed to prove by clear and convincing evidence that the applicable standard of care required Respondent to advise D. W. that she should return to the office if she felt the mass again or any changes in the mass. The medical records are adequate for the limited purpose of the April 11 visit. They describe the findings and adequately outline Respondent's examination of D. W. They justify the course of treatment--which was effectively no treatment--for the reasons set forth in the preceding paragraphs. For the reasons set forth above, Petitioner has failed to prove by clear and convincing evidence the material allegations of the Administrative Complaint.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. ENTERED on May 31, 1996, in Tallahassee, Florida. ROBERT E. MEALE, 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 on May 31, 1996. APPENDIX Rulings on Petitioner's Proposed Findings 1-3: adopted or adopted in substance, except she told him about the lump. Respondent never saw a lump. 4: adopted or adopted in substance, except that Respondent did not feel the marble-like mass that D. W. felt. Respondent felt only fibrocystic changes in the breast. 5-9 (second sentence): adopted or adopted in substance. 9 (remainder): rejected as irrelevant and recitation of testimony. 10-11 (second sentence): adopted or adopted in substance. 11 (remainder): rejected as irrelevant and recitation of testimony. 12-13 (first sentence): adopted or adopted in substance. 13 (remainder)-15: rejected as subordinate. 16 (first sentence): adopted or adopted in substance. 16 (second sentence)-17: rejected as recitation of evidence. 18: adopted or adopted in substance, as distinguished from the 2 cm tumor within the larger excised mass. 19: rejected as subordinate. 20: rejected as unsupported by the appropriate weight of the evidence. 21: rejected as irrelevant with respect to applicable standard of care. 22: rejected as unsupported by the appropriate weight of the evidence. The questions posed Dr. Bouis were ambiguous as to whether he was describing the better practice or the applicable standard of care. 23-24: rejected as irrelevant with respect to applicable standard of care. 25: rejected as subordinate and irrelevant. 26: rejected as subordinate. 27: rejected as unsupported by the appropriate weight of the evidence. 28: rejected as subordinate. 29-32: adopted or adopted in substance. 33: rejected as subordinate. 34: rejected as unsupported by the appropriate weight of the evidence. 35: rejected as subordinate. 36-38: rejected as subordinate and recitation of testimony. 39: rejected as unsupported by the appropriate weight of the evidence. 40: rejected as recitation of testimony. 41-43: rejected as unsupported by the appropriate weight of the evidence. 44-45: rejected as irrelevant. 46: adopted or adopted in substance. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-54034 Steven Rothenburg, Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Bruce D. Lamb Shear Newman 201 East Kennedy Boulevard, Suite 1000 Tampa, Florida 33602
The Issue The issue is whether Respondent is guilty of performing wrong-site surgery or performing a procedure without the patient's consent and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been licensed as a physician in the state of Florida. His license number is ME 85786. Respondent is Board-certified in anesthesiology and pain management by the American Board of Anesthesiology. Respondent has not previously been disciplined by the Board of Medicine. Patient K. D. suffered a back injury in November 1998. Following a laminectomy, Patient K. D. continued to suffer from chronic low-back pain. She visited Respondent's pain management clinic for pain relief and has been quite satisfied with the treatment that she has received from Respondent. On February 14, 2003, one of Respondent's partners performed a right-side lumbar rhizotomy by pulsed radiofrequency. The purpose of this procedure is to relieve or eliminate pain in the lower back. When performed by pulsed radiofrequency, the rhizotomy would probably not have been successful if the patient still experiences pain two weeks after the procedure. Two weeks later, on February 28, Patient K. D. presented for a left-side lumbar rhizotomy, which Respondent was to perform. Immediately prior to the surgery on February 28, while Patient K. D. was in pre-op, Respondent performed a physical examination and observed that Patient K. D. indicated pain on the right side. In response to questioning, Patient K. D. confirmed that her right side was more painful than her left side. Respondent said that he would therefore perform a right-side lumbar rhizotomy. Patient K. D. did not disagree or object, but consented to the procedure--in the presence of two nurses, as well as Respondent. Immediately after their pre-op discussion, Patient K. D. was administered Versed, which produces an effect of amnesia. To some extent, this drug may cause some retrograde amnesia, so that Patient K. D. might not recall events immediately preceding the administration of the drug, such as her physical examination and conversation with Respondent in pre-op. Respondent performed a right-side lumbar rhizotomy without incident. However, immediately after the procedure, Patient K. D. said that she also suffered left-side pain and questioned why Respondent had performed the procedure on her right side. When Patient K. D. complained that transportation problems would make it hard for her to re-schedule a left-side procedure, Respondent performed a left-side procedure, on the same day, and he completed this procedure also without incident. Prior to the February 14 and 28 procedures, Patient K. D. signed consent forms. The consent form for the February 14 procedure identifies a right-side procedure, and the consent form (actually, there are two identical forms) for the February 28 procedure identifies a left-side procedure. The forms state: It has been explained to me that during the course of an operation, unforeseen conditions may be revealed that necessitate an extensive exchange or change of the original procedure or different procedures, and I therefore authorize and require my physician or surgeon . . . to perform such surgical procedures as are necessary and desirable in the exercise of his and/or their professional judgement. . . . Petitioner's expert witness opined that a change in location, even under the above-described circumstances, "should" have been documented on a consent form, but later conceded that this is not strictly necessary. On cross-examination, Petitioner's expert witness admitted that a patient may give informed consent verbally or by conduct. Petitioner's expert witness properly discredited Respondent's theory that he had some form of ongoing consent because the forms bore no expiration date. However, to the limited extent that Petitioner's expert witness implied a requirement for written informed consent, his opinion is unsupported by Florida law, as set forth below. In contrast to Petitioner's expert witness, Respondent's expert witness did not equivocate on the issue of the required form of informed consent. Relying largely on the testimony of Patient K. D., Respondent's expert witness testified that Respondent had obtained the informed consent of Patient K. D. to perform a second right-side procedure. Aside from the obvious advantages of a written informed consent, Respondent's expert witness convincingly testified that informed consent is a state of mind, not a signature on a piece of paper, and, by this standard, which is consistent with Florida law, as set forth below, Respondent had Patient K. D.'s informed consent to perform a second right-side procedure on February 28 and thus had been duly authorized to do so.
Recommendation It is RECOMMENDED that Petitioner dismiss the Administrative Complaint, as amended, against Respondent. DONE AND ENTERED this 21st day of November, 2005, in Tallahassee, Leon County, Florida. S _ ROBERT E. MEALE 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 21st day of November, 2005. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Irving Levine Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Dennis A. Vandenberg Peterson Bernard 1550 Southern Boulevard West Palm Beach, Florida 33406
The Issue The issue for determination is whether respondent committed the offenses set forth in the administrative complaint and, if so, what action should be taken.
Findings Of Fact Craig William Herman, M.D. (Respondent) is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME0043959. Respondent has been licensed in Florida since 1984. Respondent is Board certified in urology. On March 27, 1992, Patient E. G., a forty-five year old male, presented to Respondent for a male fertility evaluation. When a patient presents for an infertility evaluation, it is appropriate for a urologist to obtain a urologic history and to evaluate urologic problems. Patient E.G.'s history was consistent with his chief complaint of infertility. His history includes that, during his seven years of marriage to his first wife no children were conceived even though no contraceptives were used and that, after remarrying, Patient E.G.'s second wife was not able to conceive even though she had a child from her previous marriage. Respondent's further evaluation of Patient E.G. on March 27, 1992, revealed that Patient E.G. suffered from urinary hesitancy and nocturia two to four times per night. The nocturia and urinary hesitancy are symptoms of an outlet obstruction. Additionally, on March 27, 1992, Respondent performed a physical examination including a digital rectal examination. The examination revealed, among other things, that Patient E.G. had a firm 2+ prostate and bilateral varicoceles. A firm 2+ prostate indicates an enlarged and suspicious prostate. Respondent also performed various tests on this first visit. He took a urine culture and performed a urinalysis, a bladder ultrasound scan (echography) and a prostate ultrasound scan (transrectal ultrasound). Respondent had a concern for possible prostate infection and outlet obstruction. The bladder ultrasound, which is a non-invasive procedure, was performed to address this concern and was medically indicated. Because of the abnormality of the prostate, the prostate ultrasound was performed to evaluate the prostate and was medically indicated. The prostate ultrasound or transrectal ultrasound of the prostate revealed a hypoechoic region of the prostate. Such a result was positive and Respondent interpreted it as suggestive of a lesion or carcinoma of the prostate. Patient E.G.'s urine culture, urinalysis, and bladder ultrasound scan produced normal results. Included as a procedure on this first visit was a semen analysis. Respondent sent Patient E.G. to Holy Cross Hospital for the analysis. The results of the analysis, which were received on March 30, 1992, reported a low sperm count and low motility. On April 3, 1992, Patient E.G. returned to Respondent for a follow-up appointment. On this second visit, Respondent performed or ordered several tests on Patient E.G.: repeat urinalysis, repeat urine culture, repeat prostate ultrasound, a prostate biopsy, renal and scrotal ultrasound, SMAC-25, free testosterone, prolactin, prostate specific antigen (PSA) blood test, and uroflometry. The prostate biopsy was medically indicated due to Patient E.G.'s firm prostate discovered during the digital rectal examination and due to the observation of the hypoechoic region. Respondent performed the biopsy, using the transrectal prostate ultrasound as guidance. The biopsy revealed an abnormal, benign growth known as hyperplasia. As Patient E.G.'s transrectal biopsy procedure was performed in Respondent's office, Respondent was not required to prepare a biopsy operative report. A copy of the pathology report for the biopsy procedure was in Respondent's medical records for Patient E.G. The scrotal ultrasound, as an evaluative procedure for a fertility patient, was medically indicated. The ultrasound was used as an objective procedure to review Patient E.G.'s bilateral varicoceles. The hormonal tests, consisting of testosterone and prolactin, were medically indicated as part of the fertility evaluation. An evaluation of Patient E.G.'s hesitancy was medically indicated, using the uroflometry as the evaluative procedure. The results were abnormal which suggested obstructive uropathy or bladder outlet syndrome. Because of Patient E.G.'s abnormal uroflow results and enlarged prostate, Respondent determined that Patient E.G.'s upper and lower urologic tract should be examined. The renal ultrasound was medically indicated to assist in determining whether an obstruction existed within the upper urologic tract. The results from the renal ultrasound revealed a suspicious cyst or mass in Patient E.G.'s left kidney. A follow-up ultrasound on the left kidney was medically indicated. The second ultrasound was performed on April 13, 1992. The results of all the remaining tests were within normal limits. Subsequently, on April 13, 1992, Patient E.G. returned to Respondent for another follow-up appointment. On this third visit, Respondent performed the following procedures: repeat urinalysis, repeat urine culture, and repeat ultrasound scan of the left renal unit (kidney). Bilateral renal ultrasounds are more common than an ultrasound of only the left kidney. However, no cost evidence was presented regarding the cost of a bilateral ultrasound versus a unilateral renal ultrasound. Patient E.G.'s ultrasound scans and tests performed on April 13, 1992, all produced normal results. All of the ultrasound examinations, except for one renal examination, conducted during Patient E.G.'s three visits were performed in Respondent's office. On all three visits, Respondent ordered Patient E.G.'s urine to be tested. The tests consisted of a urinalysis, culture, and sensitivity which are diagnostics procedures used to detect infection. If there is a concern about an infection, it is medically indicated to order these tests during each visit. Respondent had a concern regarding infection on each office visit. Patient E.G.'s infertility, his exhibited urologic symptomatology and his low semen volume are indicators of infection. Furthermore, after the biopsy, which is an invasive procedure, testing is appropriate to determine the presence of an infection. The urinalysis, culture and sensitivity were all medically indicated tests for each of Patient E.G.'s visits. Respondent's medical records included the specific laboratory results of each test which was performed on Patient E.G. As to the ultrasounds, Respondent is not required to prepare an independent written evaluation of an ultrasound film when the films are present in the chart unless a formal reading is requested. The ultrasound films were present in the chart, and no formal reading of the films was requested. Respondent practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar Board certified urologist as being acceptable under similar conditions and circumstances. Respondent's medical records justify the course of treatment of Patient E.G. Respondent did not exploit Patient E.G. for financial gain.
Recommendation Based on the foregoing Findings of Fact and Conclusions of law, it is RECOMMENDED that the Board of Medicine dismiss Counts One, Two and Three of the administrative complaint. DONE AND ENTERED this 5th day of April, 1996, in Tallahassee, Leon County, Florida. ERROL H. POWELL, 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 5th day of April, 1996. APPENDIX The following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact Partially accepted in finding of fact 1. Partially accepted in finding of fact 2. Partially accepted in finding of fact 3. Partially accepted in finding of fact 3. Partially accepted in finding of fact 5. Partially accepted in finding of fact 9. Partially accepted in finding of fact 13. Partially accepted in finding of fact 12. Partially accepted in finding of fact 14. Partially accepted in finding of fact 14. Partially accepted in finding of fact 15. Partially accepted in finding of fact 15. Partially accepted in finding of fact 17. Partially accepted in finding of fact 25. Partially accepted in finding of fact 25. Partially accepted in finding of fact 27. Rejected as being argument, or a conclusion of law. Partially accepted in finding of fact 3. Rejected as being contrary to the greater weight of the evidence. Partially accepted in finding of fact 7. Partially accepted in findings of fact 7, 13, and 24. Partially accepted in findings of fact 15 and 24. Partially accepted in findings of fact 7 and 8. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Partially accepted in finding of fact 28. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Respondent's Proposed Findings of Fact Partially accepted in finding of fact 1. Partially accepted in finding of fact 2. Rejected as being unnecessary, argument, or conclusion of law. Rejected as being unnecessary, argument, or conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 3. Partially accepted in finding of fact 4. Partially accepted in finding of fact 5. Partially accepted in finding of fact 7. Partially accepted in finding of fact 8. Partially accepted in findings of fact 6, 8, 10 and 11. Partially accepted in finding of fact 6. Partially accepted in findings of fact 6, 9 and 10. Partially accepted in finding of fact 10. Partially accepted in findings of fact 9 and 11. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 12. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in findings of fact 15 and 16. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 16. Partially accepted in finding of facts 12 and 17. Partially accepted in finding of facts 15 and 19. Partially accepted in finding of fact 19. Partially accepted in findings of fact 15 and 20. Partially accepted in findings of fact 15 and 21. Partially accepted in finding of fact 22. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in findings of fact 15 and 22. Partially accepted in finding of fact 23. Partially accepted in finding of fact 26. Partially accepted in finding of fact 29. Partially accepted in finding of fact 29. Partially accepted in finding of fact 30. Partially accepted in finding of fact 30. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 34. Partially accepted in finding of fact 34. Partially accepted in findings of fact 10, 11, 16, 20, 21, 22, 23, 29, 30, and 34. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 32. Partially accepted in finding of fact 33. Partially accepted in finding of fact 31. Partially accepted in finding of fact 18. Partially accepted in finding of fact 33. NOTE: Where a proposed finding has been partially accepted, the remainder has been rejected as being irrelevant, unnecessary, cumulative, contrary to the greater weight of the evidence, argument, or a conclusion of law. COPIES FURNISHED: Hugh R. Brown Staff Attorney Agency for Health Care Administration, Board of Medicine 1940 N. Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Mark A. Dresnick, Esquire Grand Bay Plaza, Suite 201 2665 South Bayshore Drive Miami, Florida 33130 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308
The Issue The issue in this case is whether the Board of Medicine should discipline the Respondent, Carlos C. Soriano, M.D., on allegations contained in an Administrative Complaint filed against the Respondent in DPR Case No. 89-05941: namely, allegations that the Respondent practiced medicine below the acceptable level of care, skill and treatment, in violation of Section 458.331(1)(t), Fla. Stat. (1993), by failing to offer one of his patients the option of radiation therapy or chemotherapy for cancer of the rectum and by inappropriately delaying treatment for the condition.
Findings Of Fact The Respondent, Carlos C. Soriano, M.D., is a physician licensed in the State of Florida, holding license number ME 0024149. In late 1988 and early 1989, the Respondent, Carlos C. Soriano, M.D., was the medical director of a health maintenance organization called Gold Plus. On or about October 24, 1988, a physician at Gold Plus examined the patient in question, a 90 year-old female in apparent good health for her age, and made a preliminary diagnosis of suspected cancer of the rectum. She referred the patient to the Respondent, a surgeon, for further evaluation and treatment. The Respondent examined the patient on October 31, 1988. He confirmed his associate's preliminary diagnosis of cancer of the rectum but pointed out that a flexible sigmoidoscopy with biopsy would be necessary to make a final diagnosis and to determine the kind of cancer involved. The diagnostic procedure was scheduled for November 17, 1988. The Respondent also discussed with the patient that, due to her age and the size and extent of the tumor, surgical removal of the tumor may not be appropriate. The Respondent suggested that the best course might be to perform a palliative colostomy, if necessary, and "let nature take its course." The patient was not pleased with the Respondent's attitude and consulted a nephew, who was a physician, for advice. The nephew referred the patient to another physician, who was a gastroenterologist, for a second opinion. The gastroenterologist examined the patient on or about November 8, 1988, prepared a report for the referring physician, with copies also sent to the patient and to the Respondent. The gastroenterologist's report recommended: a colonoscopy and biopsies like those already scheduled by the Respondent; a complete work-up preliminary to surgical removal of the tumor (including CEA levels, a liver/spleen scan, chest X-ray, and CT scan of the pelvis) to determine whether the cancer had metastasized; and (3) radiation therapy if there was no evidence of metastasis, or palliative radiation prior to snare polypectomy or laser fulguration, to avoid the necessity of a colostomy in the future if there was evidence of metastasis. The Respondent performed the flexible sigmoidoscopy and three biopsies as scheduled on November 17, 1988. He told the patient he would discussed the results with her as soon as they were received from the pathology laboratory. The Respondent received the pathology report and scheduled an appointment to discuss the results with the patient and her family (another nephew, and his wife) on November 30, 1988. The pathology report on the biopsies confirmed that the tumor was malignant. The report stated that the cancer was coacogenic. At the time, and to this day, radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinomas. Assuming the accuracy of the report, the only course of possible effective curative treatment for the patient was surgical removal. Whether or not the cancer had spread, the Respondent did not think surgical removal was appropriate for the patient, due to her age and the size and extent of the tumor. He did not think she would tolerate the kind of surgery that would be required. The decision whether to perform a particular surgery on a particular patient requires the exercise of the physician's professional medical judgment. Such a judgment cannot be made without a knowledge of the patient, through history and physical examination. It is found that, based on all of the evidence, including the Respondent's knowledge of the patient, through history and physical examination, the Respondent's medical judgment not to recommend surgical removal of the patient's tumor was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the meeting with the patient and her family on November 30, 1988, the Respondent explained the results of biopsies and what he considered to be the treatment alternatives. He told them that he would not recommend surgical removal, due to the patient's age and the size and extent of the tumor. He mentioned but did not elaborate on the possibility of radiation therapy because he did not know much about it. He suggested that the patient consider a colostomy to bypass the tumor and to "let nature take its course." He informed the patient and her family that he would be out of the country on vacation for the next four weeks but that she should make an appointment to see him after the holidays. Meanwhile, he would have someone research for him whether radiation or other alternative treatment modes were appropriate. It is found that the Respondent's failure to recommend radiation therapy or chemotherapy was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinoma. Assuming the accuracy of the pathology report on the biopsy, the only course of possible effective curative treatment for the patient was surgical removal. Subsequent events revealed that the patient's cancer was not coacogenic but rather squamous cell carcinoma. (It is not uncommon for biopsy reports to make such an error due to the relatively small size of the biopsy sample.) But even if the biopsy report had shown that the patient suffered from squamous cell carcinoma, it could not be found that the Respondent's failure to recommend radiation therapy or chemotherapy was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In 1988 and 1989, the medical community did not recognize radiation therapy or chemotherapy as an acceptable curative treatment for squamous cell carcinoma of the anus. Once again, the patient became anxious that the Respondent was not offering any curative treatment plan. She asked whether the Respondent should not at least have a liver/spleen scan done to see if the cancer had metastasized. Since the Respondent was not recommending surgery (the only possible curative treatment), he did not think a liver/spleen scan would serve any useful purpose. But to satisfy the patient, and because it was one of the gastroenterologist's recommendations, he agreed to schedule one for the patient before he left for vacation. The patient scheduled a follow-up appointment for January 9, 1989. Meanwhile, the Respondent left for vacation, and the liver/spleen scan was performed on December 8, 1988. In the Respondent's absence, Gold Plus delayed giving the patient the results of the scan. She became more and more anxious as time went by. When the patient called for the results, she initially was told that Gold Plus could not give her the results until the Respondent returned. It took an angry telephone call from the wife of the patient's nephew on the day before Gold Plus closed for the Christmas holiday for Gold Plus to agree to allow another of its physicians discuss the results of the scan. The patient was promised that the physician would call the next day. Still, no call came, and the wife of the patient's nephew called again just hours before the office closed for Christmas. The patient and her family were told that the results of the scan were negative. This distasteful experience further soured the patient's relationship with Gold Plus and, by extension, with the Respondent, and they lost faith in the Respondent and his medical practice. Instead of seeing the Respondent on January 9, 1989, as scheduled, the patient cancelled the appointment and made another appointment to see the gastroenterologist again. By this time, the tumor had grown to some extent and, along with it, the patient's discomfort. It was difficult to even examine the patient's rectum either digitally or by flexible sigmoidoscopy. The gastroenterologist agreed to refer the patient to another surgeon for possible surgical removal of the tumor. The patient initiated disenrollment from Gold Plus so that her Medicare could be reinstated to cover the anticipated surgery. The gastroenterologist asked the Respondent for the patient's medical records. The Respondent's care of the patient and responsibility for the care of the patient effectively ended when the patient cancelled her appointment on January 9, 1989. Another appointment with the gastroenterologist was scheduled for February 1, 1989, in anticipation of imminent surgery. Surgery was scheduled for February 14 but, after the patient's admission, was postponed to February 17, 1989. Initially, the patient's recovery from surgery was slow, and she remained hospitalized until March 14, 1989. Subsequent events raise questions whether the surgery was effective or worth the trauma. It is debatable how well the patient tolerated the surgery. It appears that she did not ever recover the level of physical vigor and energy she had before surgery. During the summer of 1989, the cancer reappeared on her coccyx and had to be treated by radiation. By the fall of 1989, another abdominal perineal resection was necessitated by the reappearance of the cancer in her rectum. Based on the best expert testimony available at the hearing, it cannot be found that the time that went by during the Respondent's treatment of the patient was "substantial," i.e., that it contributed to the spread of the patient's cancer. Notwithstanding the results of the liver/spleen scan, which was not definitive or even very useful in evaluating the patient's cancer for metastasis, it is probable that the patient's cancer already had metastasized by the time the Respondent first saw the patient. The Respondent clearly did not inordinately delay the flexible sigmoidoscopy with biopsy or his discussion of the results and treatment alternatives with the patient. The only questionable delay was the four-week delay caused by the Respondent being out of the country on vacation; by the time he was scheduled to see the patient on his return, she had terminated his care and treatment. There was no evidence on which it could be found that this delay was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint against the Respondent. RECOMMENDED this 21st day of March, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of March, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5068 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5.-6. The date of the procedure was November 17, not November 11. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 7.-10. Accepted and incorporated to the extent not subordinate or unnecessary. "[A]pproximately four (4) weeks after the Christmas holidays" rejected as not proven and as contrary to the greater weight of the evidence. (He said "in four weeks, i.e., after the Christmas holidays.") Accepted and incorporated. Rejected as not proven and as contrary to the greater weight of the evidence that it was just "for a second opinion." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 14.-15. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven and as contrary to the greater weight of the evidence that the gastroenterologist made such a determination; rather, the subsequent surgeon did. Also, rejected as not proven and as contrary to the greater weight of the evidence that the surgery was "successful." In some senses it was, in other senses it was not. Rejected as not proven and as contrary to facts found. 18.-19. Accepted but subordinate to facts contrary to those found, and unnecessary. 20. Both as to the growth of the tumor and as to the evidence of metastasis, rejected as not proven and as contrary to the greater weight of the evidence. (The liver/spleen scan was negative, but the best expert testimony presented as the hearing indicated that subsequent events showed prior metastasis.) 21.-22. Rejected as not proven and as contrary to facts found. (The evidence was that those treatments were not alternative curative treatments. The Respondent was not given an opportunity to use them palliatively.) 23. Rejected as not proven and as contrary to facts found. Respondent's Proposed Findings of Fact. For purposes of these rulings, the Respondent's unnumbered paragraphs of proposed findings of fact are assigned consecutive numbers. 1.-3. Accepted but subordinate and unnecessary. 4.-6. Accepted and incorporated to the extent not subordinate or unnecessary. 7. As to the second sentence, a "transverse colostomy" was discussed, not a "transverse colonoscopy." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 8.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to facts found and to the greater weight of the evidence that there was no delay. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Subordinate and unnecessary. COPIES FURNISHED: Barbara Makant, Esquire Steven A. Rothenburg Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Hugh Smith, Esquire P. O. Box 3288 Tampa, Florida 33601 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire Acting General Counsel Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792
The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon an alleged failure in the level of care and treatment of J.P., his patient?
Findings Of Fact STIPULATED FACTS: Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes, and Chapter 458, Florida Statutes. The Respondent, whose address of record is 1834 SW 1st Avenue, Ocala, Florida 34474, was issued license number ME 56306. At all times material to this Complaint, the Respondent was a licensed medical physician within the State of Florida. Respondent specializes in pulmonology. Respondent was Patient J.P.'s attending physician. Respondent ordered a bronchoscopy and specimens that revealed possible Mycobacterium Avium-Intracellulare (MAI). The biopsies revealed signs of granulomalous infection as seen in MAI or tuberculosis (TB). During this (his) hospital stay, Patient J.P. was started on the drug ethambutol at 1600 mg daily. It is the manufacturer's recommendation that the dose of ethambutol, if started at 25 mg per kilogram per day, should be reduced to 15 mg per kilogram per day after 60 days. The infections (infectious disease) specialist saw Patient J.P. in his office on or about July 26, and August 8, 2000 and in his August 18, 2000 letter to Respondent, there was no mention or recommendation for a change in Patient J.P.'s dosage after two months on the ethambutol therapy. Patient J.P. was subsequently seen by the Respondent on October 23, and again on December 27, 2000, when Patient J.P. complained of eye problems. At this later visit Respondent immediately discontinued the ethambutol and referred Patient J.P. to an eye specialist. ADDITIONAL FACTS: Patient J.P.: On May 8, 2000, Patient J.P. was seen at Ocala Lung and Critical Care Associates (Ocala Lung and Critical Care) in Ocala, Florida. This practice is Respondent's Professional Association. The patient had been referred by Dr. Dave Metcalf. On that date the patient was seen by Respondent's associate, Poonan Warman, M.D. According to the note in the patient records for that date, the patient reported a complaint of "cough and cold" with no weight loss. (Petitioner's Exhibit No. 1, page 28) On May 23, 2000, the patient returned to Ocala Lung and Critical Care. Again Dr. Warman saw the patient. A note in the patient's chart describes J.P.'s condition on that date. (Petitioner's Exhibit No. 1, page 35) At that time Dr. Warman concluded that the patient had a mass in his left lung with right lung abscess. Dr. Warman scheduled a bronchoscopy and prescribed mediation. On June 13, 2000, Respondent first say Patient J.P. at Ocala Lung and Critical Care. At that time Respondent made notes in the patient's chart concerning the patient's condition. (Petitioner's Exhibit No. 1, page 49) Respondent assessed the condition as a system in the patient's right upper lobe, possible lung abscess. The note refers to the provision of an antibiotic, a CBC differential and CRP that was ordered. This was a follow- up visit for the bronchoscopy that had been performed by Dr. Warman. Cultures in association with the organism found through the bronchoscopy were pending. At that time Respondent's recommendation to the patient was to continue the antibiotic treatment of Augmentin as well as Clindamycin. The patient was to be seen back in a month's time, according to a typed note within the patient's chart bearing Respondent's signature. (Petitioner's Exhibit No. 1, page 48) In that same typed note it was noted that the bronchoscopy and the biopsy that had also been performed did not reveal malignancy but chronic inflammatory cells had developed. The type-written impression entered in the chart was right upper lobe cavitary lesion, most likely lung abscess. On this date Respondent concluded that the patient had bacterial infection in the lung and the lung abscess. Respondent wanted blood work done to monitor the side effects of the antibiotics being given. Respondent discussed the side effects of the medication with the patient as noted in the written entries in the chart. In relation to the antibiotic medications that were provided to Patient J.P., notes were made on June 14 and 20, 2000, in the patient records maintained by Ocala Lung and Critical Care, commenting on the efforts by the practice to assist Patient J.P. in obtaining those medications from that office and other doctors' offices because of his inability to pay for the medicine. (Petitioner's Exhibit No. 1, page 47) On June 27, 2000, Respondent saw Patient J.P. at the Monroe Regional Medical Center (the Medical Center) in Ocala, Florida, for a medical emergency. The Medical Center is a hospital. At that time the patient's chief complaint was a right-side chest pain. The patient was admitted to the Medical Center by Frank E. Reisner, M.D. The patient had called Respondent's office before his admission. Under the circumstances Respondent was concerned that the patient would not receive adequate treatment as an outpatient. It was recommended that the patient be admitted for inpatient hospital treatment of his lung abscess. On June 27, 2000, the emergency department note in the hospital record refers to the admission of Patient J.P. to the service of Dr. Mishra, an internist at the hospital. (Petitioner's Exhibit No. 1, page 354) Dr. Mishra had also spoken to Patient J.P. and told the patient to come to the hospital. Because the Patient J.P. had a lung abscess problem and had been seen by Respondent in the past, Respondent became responsible for the patient in the hospital upon the request of another physician. Respondent's decision to have the patient remain admitted for treatment of the lung abscess was made the same day the patient arrived at the hospital. Under this arrangement Respondent was the attending physician. On June 28, 2000, after receiving the chart for Patient J.P. from Respondent's office, to review the patient history and based upon results at the hospital that revealed the patient had possible MAI present in bronchial washings from a bronchoscopy performed in the hospital, Respondent decided to consult with Lee Prchal, M.D., who specializes in infectious disease and practices in Ocala, Florida. The reason for the consultation was that Respondent does not treat MAI. Decisions about the appropriateness of treatment for MAI, in Respondent's view, would best be made by a physician specializing in infectious diseases. Respondent did not feel comfortable treating MAI, in that he did not have sufficient knowledge about the condition and its treatment. If Dr. Prchal thought that the patient needed to be treated for MAI, Respondent expected that the other physician would be responsible for the care. With this in mind Respondent did not follow the patient as an attending physician would normally during the patient's stay in the hospital. Nonetheless, Respondent was aware that Patient J.P. had been prescribed ethambutol, also referred to as ethambutol hydrochloride or by the generic drug name Myambutol. Respondent understood that the medication had been prescribed initially in a setting in which it was uncertain whether the patient had a problem with MAI or tuberculosis. Dr. Prchal had written the order for ethambutol given to Patient J.P. in the hospital stay. Dr. Prchal intended to address any MAI with the medication. Dr. Prchal did not write orders for ethambutol upon the patient's discharge, although the patient continued to take the medication. Respondent did not order an initial visual acuity test when Patient J.P. was first prescribed ethambutol in the hospital stay. Dr. Prchal did not order visual testing to establish a baseline while the patient was hospitalized. At no point during the time Patient J.P. was treated with ethambutol did Respondent consider himself responsible in addressing MAI. Respondent did not believe that he had the duty to manage the treatment. He believed that Dr. Prchal was responsible while the patient was in the hospital and upon the patient's discharge. On July 19, 2000, following the Patient J.P.'s discharge from the hospital, Respondent saw the patient again in an office visit. Notes concerning that visit were made. (Petitioner's Exhibit No. 1, page 84) The notes reflect that the patient was doing well, and his cough had improved. Respondent's impression was that the patient had atypical TB and COPD. COPD refers to Chronic Obstructive Pulmonary Disease. At the time it was noted that the patient was advised to keep in touch with HRS for atypical TB. HRS refers to Health and Rehabilitative Services. In actuality, the Marion County Health Department was the health organization that Respondent had in mind. The comment on HRS is in association with an adult clinic in Ocala, Florida. According to a note in the patient record made by a member of Respondent's staff, someone previously had spoken to a person from the Health Department, who said that Patient J.P. did not have tuberculosis. This meant that the TB clinic with the Health Department would not follow his case for tuberculosis, but he could be followed in the adult health clinic for the condition he did have and that clinic should be able to help the patient with needed medication. (Petitioner's Exhibit No. 1, page 47) The adult health clinic is a general clinic affiliated with the Department of Health, and if seen in the general clinic Respondent believed that the patient could be provided needed medications. Patient J.P. had experienced difficulties obtaining needed medication in the past. As before, Respondent did not examine Patient J.P. in relation to visual acuity. The patient offered no complaints about his vision at this visit. On the July 19, 2000 visit Respondent did not consider reducing the ethambutol dosage for Patient J.P. The patient was referred to Dr. Prchal for a visit on July 26, 2000, in relation to MAI. Given the referral to Dr. Prchal, Respondent proceeded on the basis that Dr. Prchal was responsible for treating Patient J.P. for MAI. It was intended that the patient return to see the Respondent on October 23, 2000. Patient J.P. saw Dr. Prchal on July 26, 2000. Following that visit Dr. Prchal wrote the Respondent. The letter was dated August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) In concluding remarks Dr. Prchal stated in the correspondence: Therefore, at this time, I would recommend continued ethambutol and biaxin for treatment of his MAI. The duration of his clindamycin will require your clinical judgment, but in view of his radiographic changes, it may require further prolonged administration. Respondent's reading of the correspondence was that Dr. Prchal would continue to monitor and be responsible for ethambutol therapy while deferring to Respondent to treat the lung abscess with Clindamycin. On October 23, 2000, Respondent saw Patient J.P. in Respondent's office. Handwritten notes were made by the Respondent during the visit, followed by typewritten notes for the patient's record. (Petitioner's Exhibit No. 1, pages 90 and 91) The patient records refer to the Respondent's perception that Dr. Prchal was treating MAI with multiple antibiotics. The note refers to COPD, lung abscess and MAI. Respondent asked the patient to discontinue Clindamycin and to continue Biaxin. Respondent also asked Patient J.P. to continue taking ethambutol. Respondent did not consider himself to be responsible for treating MAI with ethambutol. In the typed document for the patient record pertaining to the October 23, 2000 visit, it is indicated under the section dealing with Respondent's impression that the lung abscess healed resulting from treatment with clindamycin. At the same time the typed notes indicated that MAI would require long-term treatment. Although Respondent contends that Dr. Prchal would follow Patient J.P. routinely for MAI, the typewritten note describes Dr. Prchal's August 18, 2000 correspondence as a "final note." On October 23, 2000, the patient did not complain of any problems with visual acuity and no eye examination was ordered by Respondent. No specific inquiry was made concerning the patient's progress with the MAI. A follow-up appointment was scheduled for December 27, 2000. Patient J.P. kept that appointment. On December 27, 2000, Patient J.P. complained of an eye problem. He told Respondent that he was not able to see and that two weeks before he had seen an eye physician. As the patient record indicates, the patient complained to Respondent whether this problem with his vision was due to medicine. As a record on the patient care states, authored by Respondent, Respondent indicates "In response, [to complaints about the patient's vision] I have stopped his ethambutol." The impression in the patient record that was typed indicates as well "Ethambutol is being stopped today." This patient record is by way of a letter from Respondent to Dr. Prchal. (Petitioner's Exhibit No. 1, page 93) The letter goes on under the portion referred to as "Plan" to say, "I referred him back to you [Dr. Prchal] for evaluation of the disease process and then we will decide how long he will require the Biaxin." The discussion given thus far of the facts, includes the perspective of the Respondent as to his explanation of care for MAI in Patient J.P. The next part of the discussion is in relation to testimony by deposition by Dr. Prchal including his explanation of his care for MAI provided Patient J.P. Dr. Prchal has practiced in Ocala, Florida, since 1987. His primary specialty is infectious disease. His first encounter with Patient J.P. was at the Medical Center when the patient was referred to him by Respondent, the attending physician, to consult as an infectious disease specialist. When Patient J.P. was first seen, the working differential, as Dr. Prchal recalls it, was that the patient had an underlying chronic lung disease with a history of smoking and a family history of lung cancer. The patient had failed outpatient treatment and when seen could have underlying cancer and/or infections in his lung. Following the bronchoscopy performed on the patient in the hospital, Dr. Prchal wrote an order for ethambutol 1600 mg. The order was written on June 28, 2000. He wanted the patient to receive ethambutol because it was an antibiotic that is used for treating MAI. As Dr. Prchal describes, MAI is a germ in the family of tuberculosis. The patient received his first dose of ethambutol on June 29, 2000. The reason for prescribing 1600 mg of ethambutol was in recognition of the patient's weight. The dosage was presented in four tablets of 400 mg. Dr. Prchal's view of the prescription of ethambutol was that he had signed-off on the case before the patient was discharged from the hospital. At the same time, he considered the use of ethambutol to be open-ended and dependent upon the clinical response by Patient J.P. beyond his discharge. The concluding point for using ethambutol was to be decided by Respondent, in Dr. Prchal's perception, in that Respondent was the attending physician and the main person in charge of the case. Dr. Prchal's view of the choice of dosage of milligrams per kilograms of weight ranging from 15 mg to 25 mg per kilogram of weight, depends upon the person's clinical circumstance. The common starting dose is 25 mg per kg, in his view. Dr. Prchal's experience with ethambutol is that he had prescribed ethambutol to more than 50 patients. Dr. Prchal realized that optic neuritis is a potential side effect in the use of ethambutol. Dr. Prchal does not believe that baseline vision testing is necessary before providing ethambutol therapy. Dr. Prchal is familiar with the PDR concerning ethambutol, which he considers to be the manufacturers guidelines for use of that medication. In relation to the PDR reference to monthly testing for visual acuity during the use of ethambutol, particularly in dosages in the amount of 25 mg per kg, Dr. Prchal refers to the difficulty in having an ophthalmologist see patients for screening in the Ocala area and the difference of opinion among members of the medical community concerning screening. He does not believe that there is a specific standard to be followed in the community for screening. When Patient J.P. was in the hospital receiving his first dosage of ethambutol on June 29, 2000, Dr. Prchal indicated that baseline vision testing was not available in that setting and could only be done following the discharge of the patient. The frequency of testing beyond baseline testing would be on a case by case basis. According to Dr. Prchal, visual monitoring is part of the overall monitoring in the use of ethambutol. In Dr. Prchal's physician progress notes for Patient J.P. made on July 1, 2000, at the hospital, pertaining to ethambutol he referred to "appropriate monitoring." He then goes on to say that he "will sign off." He explains the latter reference to indicate that he was signing-off on the case. (Petitioner's Exhibit No. 1, page 121) Dr. Prchal saw Patient J.P. on July 26, 2000. At that time the patient was continuing with ethambutol. Dr. Prchal inquired about any visual symptoms. Patient J.P. responded that he did not have visual symptoms. The patient told Dr. Prchal that he had been referred to the Marion County Health Department. In Dr. Prchal's opinion the patient's medical condition at the time was better and the medicine seemed to be working. This is taken to mean that the ethambutol was working. Dr. Prchal saw Patient J.P. on August 8, 2000. This was their last visit. As with the visit on July 26, 2000, when Dr. Prchal saw Patient J.P. on August 8, 2000, the patient expressed no complaints about his vision. On August 8, 2000, Dr. Prchal had determined that the patient did not have tuberculosis, and medications to treat that disease were not necessary and could be discontinued. The medications for treating tuberculosis were IMH, Tyrazinamide and Rifampin. Dr. Prchal thought that ethambutol for treating MAI was still called for, together with Biaxin. Dr. Prchal did not have in mind a specific dosage of ethambutol. Being persuaded that Respondent was the attending physician overseeing the care, Dr. Prchal made known his views in the correspondence to Respondent on August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) Dr. Prchal believes that the reason for Patient J.P.'s visits on July 26, 2000, and August 8, 2000, was Respondent's desire to know what medications still needed to be continued in treating the patient. EYE CARE The day before Patient J.P. saw Respondent on December 27, 2000, the patient had been at Ritz Eye Care. The reason for his visit was "check eyes-has trouble seeing." (Petitioner's Exhibit No. 1, page 192). On the visit to Ritz Eye Care he was seen by Daniel L. Ritz, O.D. Dr. Ritz consulted with Robert N. Mames, M.D., specializing in diseases and surgery of the Vitreous and Retina. Dr. Mames performed an ophthalmic examination and diagnosed the Patient J.P.'s condition as (1) decreased visual acuity in both eyes; (2) minimal nuclear sclerosis; and (3) history of lung abscess, Mycobacterium Avium. In his impression Dr. Mames said "etiologies include optic neuropathy secondary to ethambutol versus CAR syndrome (Canon-associated retinopathy), which is unlikely with no history of cancer." These findings were made in the report from Dr. Mames to Dr. Ritz dated January 16, 2001. (Petitioner's Exhibit No. 1, page 199) Patient J.P. was seen at the University of Florida, College of Medicine, Department of Ophthalmology, on March 23, 2001, by M. Tariq Bhatti, M.D., an assistant professor of the Department of Ophthalmology and Neurology. He indicates in correspondence to Mandouh H. Zeini, M.D., practicing in Ocala, Florida, "It appears that Mr. P. has bilateral optic atrophy. As you are aware, ethambutol is a well-known toxin to the optic nerves. However, I think it would be important to rule out other treatable causes of his optic atrophy. Therefore, I have recommended B-12, folate level, sedimentation rate, syphilis serology, ANA and an MRI of the brain and orbits." (Petitioner's Exhibit No. 1, page 224) On April 25, 2001, Dr. Bhatti saw Patient J.P. again. In turn, he corresponded with Dr. Zeini on that date. (Petitioner's Exhibit No. 1, page 227) With the negative work-up on the prior tests given Patient J.P., Dr. Bhatti wrote, "I suspect Mr. P.'s bilateral optic neuropathies are ethambutol- related. He has discontinued the use of ethambutol, therefore this should remain a static process with no visual loss." PHYSICIAN DESK REFERENCE: MYAMBUTOL The PDR in referring to MYAMBUTOL under the heading DESCRIPTION states: MYAMBUTOL ethambutol hydrochloride is an oral chemo-therapeutic agent which is specifically effective against actively growing micro- organisms of the genus mycobacterium, including M. tuberculosis. In the PDR under the heading INDICATIONS it is stated: MYAMBUTOL is indicated for the treatment of pulmonary tuberculosis. The PDR refers to CONTRAINDICATIONS where it states: MYAMBUTOL is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Under PRECAUTIONS the PDR states: . . . Because the drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination. . . . In relation to ADVERSE REACTIONS the PDR states: MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis and to be related to dose and duration of treatment. . . . Patients should be advised to report promptly to their physician any change of visual acuity. . . . Testing of visual acuity should be performed before beginning MYAMBUTOL therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg. per kilogram per day. . . . In relation to INITIAL TREATMENT the PDR states: In patients who have not received previous antituberculosis therapy, administer MYAMBUTOL 15 mg. per kilogram. (7 mg. per pound) of body weight, as a single oral dose once every 24 hours. On the related subject of RETREATMENT the PDR states: In patients that have received previous anti- tuberculosis therapy, administer MYAMBUTOL 25 mgs. Per kilogram (11 mg. per pound) of body weight, as a single oral dose every 24 hours. . . . After 60 days of MYAMBUTOL administration, decrease the dose to 15 mg. per kilogram (7 mg. per pound) of body weight, and administer as a single oral dose every 24 hours. During the period when a patient is on a daily dose of 25 mg/kg monthly eye examinations are advised. EXPERT OPINION TESTIMONY: George Andrews Schoonover, M.D. has been licensed to practice in Florida since 1978. He practices pulmonary medicine in Jacksonville, Florida. He is certified in pulmonary medicine as well as internal medicine and has a sub-specialty in critical care medicine. For proposes of this hearing Dr. Schoonover was recognized as an expert in pulmonary diseases. To prepare himself for testimony at hearing he looked at the materials in Petitioner's Exhibit No. 1, which describes the care and treatment received by Patient J.P. during the relevant period. He also looked at the PDR in relation to MYAMBUTOL (ethambutol hydro-chloride). (Petitioner's Exhibit No. 3) His testimony was offered as a consultant for Petitioner. It supports Petitioner's attempt to impose discipline against Respondent's license. In interpreting the physician's progress note entered by Dr. Prchal on July 1, 2000, while Patient J.P. was in the hospital, which states "would sign off," Dr. Schoonover takes this to mean that Dr. Prchal will not be seeing the patient again, either in the hospital or as an outpatient, unless asked to formally consult at a future date. (Petitioner's Exhibit No. 1, page 121) Patient J.P. was discharged from the hospital on July 5, 2000, by Nagesh Kohli, M.D. Dr. Schoonover points out that the discharge summary explained to the patient in the discharge instructions that the patient, if experiencing any recurrence of symptoms, dyspnea, fever or questions or concerns, may call the Respondent. As well, the discharge instructions note that the patient was to follow up with Dr. Mitra in three to four weeks. (Petitioner's Exhibit No. 1, page 77) This instruction tends to coincide with the patient's visit to Respondent on July 19, 2000. Dr. Schoonover commented on the medications that Patient J.P. would continue upon discharge, in particular ethambutol 1600 mg q.d., part of the discharge summary by Dr. Kohli. This is as distinguished from the ethambutol Dr. Prchal had prescribed earlier in the hospital stay. In a patient medication record for Patient J.P. maintained by Respondent's practice, information is contained concerning ethambutol use over time. (Petitioner's Exhibit No. 1, page 9) Dr. Schoonover refers to the dosage of 400 mg four times per day, on July 19, 2000, October 23, 2000, and December 27, 2000, reflected in the patient record. Based upon the record, Dr. Schoonover assumes that Respondent was aware of the dosage of ethambutol for Patient J.P. upon these dates when the patient was seen, indicating a lack of change in the dosage over time. Dr. Schoonover commented upon the correspondence from Dr. Prchal to Dr. Mitra dated August 18, 2000. In his reading, Dr. Schoonover believes that the correspondence points out that Respondent was the physician of record from the standpoint of monitoring Patient J.P., and in treating the patient from the hospital discharge until the patient was seen by Dr. Prchal on July 26, 2000. In this connection notes made by Dr. Prchal concerning Patient J.P. in August 2000 were interpreted by Dr. Schoonover to indicate that the patient was receiving his prescriptions for medication from Respondent. (Petitioner's Exhibit No. 1, page 270) Dr. Schoonover also mentions the August 30, 2000 note in Patient J.P.'s records maintained by Respondent's practice, which describes a call by Dr. Prchal and his office note, taken to mean the correspondence directed to Respondent on August 18, 2000, in which Dr. Prchal requests Respondent to make sure that the patient has plenty of meds (medication) while Dr. Prchal was out of town through September 18, 2000. (Petitioner's Exhibit No. 1, page 89) That note maintained by Respondent in his practice indicates that the request was honored where it states, "Done." Dr. Schoonover assumes that the reference to meds would include ethambutol. Dr. Schoonover commented on the October 23, 2000 visit with Respondent as reflected in the note made on that date by Respondent (Petitioner's Exhibit No. 1, page 90), wherein it indicates that that patient is being continued on ethambutol. Dr. Schoonover believes that Respondent was responsible for monitoring that therapy and potential side effects and drug interactions associated with ethambutol. Dr. Schoonover commented on the December 27, 2000 correspondence from Respondent to Dr. Prchal, in which Respondent describes the complaint by Patient J.P. made December 26, 2000, about some eye problem, and whether the problem was due to medication. As Dr. Schoonover was aware, Respondent responded to those remarks by stopping the ethambutol. Dr. Schoonover was asked about his ability to form an opinion with a reasonable degree of medical certainty, whether the Respondent by his treatment of Patient J.P. practiced 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. He had an opinion. That opinion was that Respondent deviated from the standard of care, that the Respondent fell below the standard of care. Dr. Schoonover feels that deviation was in two areas. The first was the failure to order eye examinations for Patient J.P. The second reason was that the Respondent did not reduce the dosage of ethambutol after two months of therapy. Dr. Schoonover offered his opinion with the belief that Respondent was the attending physician in the hospital and continued to treat the patient beyond the patient's release from the hospital. Dr. Schoonover indicated that had the Respondent not ordered an initial eye examination be done, then at some subsequent point in the care the examination should have been ordered. Concerning reducing the dosage of ethambutol, Dr. Schoonover further explains his opinion that the dosage should have been reduced by Respondent after 60 days or at least determined why the specialist (Dr. Prchal) had not reduced it after 60 days. Dr. Schoonover concludes that Respondent could have taken steps to prevent the permanent visual impairment of Patient J.P. through an initial eye examination or subsequent follow-up eye examination, finding the problem early enough that this discontinuation of the medication would resolve the problem and promote improvement before permanent damage was done. Dr. Schoonover holds the opinion that Dr. Prchal also deviated from the recognized standard of care in his treatment of Patient J.P. in relation to ethambutol. He believes that both Respondent and Dr. Prchal were in a situation wherein they shared the care and they were both equally responsible and failed to meet the standard of care for the same reasons. In essence Respondent was treating the Patient J.P. for MAI as well as Dr. Prchal. In his testimony Dr. Schoonover is less precise in his opinion concerning the responsibility for a physician to order an initial eye examination for Patient J.P., testifying that it was someone's responsibility. He then goes on to say that it was several persons' responsibility and that Respondent and Dr. Prchal were among those persons. They are the persons discussed as well as Dr. Kohli. Finally, in order to find a deviation from the standard of care by Respondent, Dr. Schoonover believes that it is necessary to show that the patient had diminished visual acuity more probably than not connected to ethambutol. His reading of the April 25, 2001 correspondence from Dr. Bhatti in particular, leads him to believe that there was a connection between the use of ethambutol and bilateral optic neuropathies as described by Dr. Bhatti. (Petitioner's Exhibit No. 1, page 227) Raymond L. Parker, Jr., M.D., has been practicing in Florida since 1976. His current practice is with Pulmonary Physicians of South Florida in South Miami, Florida. He specializes in internal medicine, pulmonary disease and critical care. He is board certified in all specialties. He testified by deposition in behalf of Respondent as an expert, in particular, in relation to his specialty in pulmonary diseases. (Petitioner's Exhibit No. 2) In the deposition the parties stipulated that the witness was an expert in pulmonary diseases. That stipulation is accepted. In preparing to offer his opinion concerning the care provided by Respondent to Patient J.P., Dr. Parker had exposure to the deposition of Respondent, the deposition of Dr. Prchal, the deposition of Dr. Kohli, medical records of Dr. Prchal, Frank's Pharmacy records, medical records of Dr. Leslie Husband, medical records of Beatriz X-Ray and Imaging Center, medical records of Dr. Zeini, medical records of Dr. DiLorenzo, medical records of the Marion County Department of Health, medical records of Express Care of Belleview, and medical records of the Monroe Regional Medical Center. Dr. Parker also had exposure to records related to Patient J.P., part of Respondent's office practice. Dr. Parker comments on the bronchoscopy performed by Respondent on June 29, 2000, while Patient J.P. was in the hospital, in which the bronchoscopic specimen showed no endoscopic evidence of malignancy. Based upon the results of the bronchoscopy in the hospital and an earlier bronchoscopy performed a Dr. Warman on June 7, 2000, Dr. Parker was persuaded that the patient was going to be treated for MAI based upon cultures that grew out from the procedures. Further, Dr. Parker refers to the discharge diagnosis when Patient J.P. left the hospital, where it is stated that the patient had atypical tuberculosis, MAI, in addition to a right-upper lobe abscess and COPD. Dr. Parker's refers to the progress note dated July 1, 2000, when Patient J.P. was in the hospital, made by Dr. Prchal, in which Dr. Prchal recommends 400 mg tablets, four times daily of ethambutol, totaling 1600 mg, as being part of a treatment for TB and MAI pending AFB culture results. Dr. Parker's reading of the note by Dr. Prchal calling for "Appropriate monitoring. Will sign off," in the context of other materials reviewed by Dr. Parker, meant that Patient J.P. was being referred to the tuberculosis health center and those persons in that facility would manage the tuberculosis and MAI issue in the future. Dr. Parker refers to information in the patient records where the wife of Patient J.P. contacted a social worker leading to the patient being informed that the tuberculosis unit did not treat MAI but that an attempt was being made to make an appointment for Patient J.P. to be seen at the adult clinic. Ultimately, Dr. Parker interprets the information he reviewed as indicating that Patient J.P.'s wife decided that an appointment needed to be made with Respondent resulting in the appointment on July 19, 2000, between the patient and Respondent. Between July 1, 2000, when Dr. Prchal wrote his "sign off" note and July 19, 2000, when the patient was seen by Respondent, Dr. Parker expressed the opinion that Respondent and Dr. Kohli were the attending physicians for Patient J.P. The prescription recommendations upon discharge would have been the responsibility of Dr. Kohli because he discharged the patient. According to Dr. Parker this included ethambutol. Dr. Parker is familiar with the PDR. He does not consider it to be an authoritative source for information among doctors. He considers that the information contained in the PDR was written years before. Consequently, it is not authoritative or up to date. Dr. Parker prescribes ethambutol for his patients but rarely. He has a special interest in MAI. He is aware of the recommendations within the PDR pertaining to visual testing and dosage for ethambutol. He considers some of the recommendations for using ethambutol to be controversial. For example, he does not recommend his patients get monthly monitoring for their vision. Instead, he recommends that they watch out for problems. He considers that this approach is the general consensus in the community where he treats patients. Specifically, Dr. Parker does not question the prescription of 25 mg per kg of patient weight for the Patient J.P. when ethambutol was first prescribed. The dosage points to the patient loosing weight, fevers and sweats, not doing well and the need to "jump on him or he would just wither away." Dr. Parker does believe that there should have been an eye test when starting the patient on ethambutol. Dr. Parker in his understanding perceives that when Dr. Kohli discharged the patient from the hospital, Dr. Kohli believed that the patient would be attending the TB Clinic for treatment and monitoring, to include baseline studies for visual acuity. Dr. Parker in his opinion looks upon the suggestion in the PDR that the dosage of ethambutol be changed over time as being a guideline and that the proper treatment is in view of the clinical needs of the patient. If the patient is improving the dosage can be reduced. If he remains very sick, he would not necessarily reduce the dose. Concerning the maintenance of 25 mg per kg over periods of three, four, five, or six months Dr. Parker says that under appropriate circumstances the maintenance of 25 mg per kg of patient weight is acceptable. He does not offer his opinion concerning this case. Concerning the prospect for reducing the dosage, Dr. Parker's review of the records does not lead him to a conclusion one way or the other. When patients are maintained on 25 mg. per kg. of patient weight, Dr. Parker expresses the opinion that more frequent eye testing is in order. If the dosage is less than that amount he would not recommend that a patient have repeat eye testing but that the patient be cautioned to quickly advise the doctor about changes in vision and or visual fields or color vision. From his review of the records Dr. Parker was aware that the patient was maintained on ethambutol 25 mg per kg of weight for approximately six months and no eye tests were provided during that period. Dr. Parker interprets the correspondence from Dr. Prchal to Respondent dated August 18, 2000, as a guiding letter for addressing Patient J.P.'s MAI, leading to the belief by Dr. Parker that Respondent deferred to Dr. Prchal in the treatment of MAI with ethambutol following that correspondence. Overall Dr. Parker does not believe that Respondent was treating Patient J.P. for MAI and had no experience with the drug ethambutol as part of that care. This meant that Dr. Parker does not believe that Respondent was addressing the MAI issue or ethambutol. Dr. Parker interprets the note in Respondent's office practice where on August 30, 2000, the call was received from Dr. Prchal referring to the office note of August 18, 2000, from Dr. Prchal. That request asks that the patient have plenty of meds while Dr. Prchal was out of town until September 18, 2000. This indicates that Dr. Prchal could not write the prescriptions and that he was requesting Respondent's office to handle the writing of prescriptions. This is not seen by Dr. Parker as turning over the management of the patient in reference to the prescriptions. In Dr. Parker's view, when consultants prescribe medication, the attending physician does not have a standard of care obligation to hold the knowledge about these drugs prescribed by the consultant for the patient. The attending physician relies upon the consultant for guidance on the drugs and any questions need to be followed up with the consultant, according to Dr. Parker. In this case he goes on to describe the expectation, upon the discharge from the hospital, that the patient would be seen by a clinic where the attending physician felt there would be necessary expertise. Dr. Parker reached an opinion on standard for care issues concerning Respondent's treatment and care of Patient J.P. His opinion is that Respondent met the standard of care because he was the treating physician limited to the lung abscess and COPD. Dr. Parker interprets the results of the July 19, 2000 visit to Respondent to be one in which Respondent realized that the patient was not going to be seen at a tuberculosis health clinic, resulting in Respondent referring the patient back to Dr. Prchal for management of MAI. Dr. Parker attaches importance to the August 18, 2000 letter from Dr. Prchal to Respondent, in which Dr. Prchal indicates a treatment plan for MAI and Respondent defers to that judgment. At the inception Dr. Parker believes Respondent was acting appropriately to refer Patient J.P. to Dr. Prchal, an infectious disease expert. Concerning the need for a baseline eye examination to be performed when ethambutol is being started, Dr. Parker thinks that is necessary. However, the physician managing the care with respect to the MAI and who ordered the medication is responsible for ordering the initial eye examination. In this case that would have been Dr. Prchal. Any follow-up eye examinations on a periodic basis would be the responsibility of the physician with a special interest in management of atypical mycobacterial disease, with some understanding of the various drugs involved, to include ethambutol. Dr. Parker believes that additional eye examinations are needed when continuing the dosage of 25 mg per kg of patient weight. Given the continuing dosage over time, Dr. Parker believes that Dr. Prchal was responsible for ordering subsequent eye examinations. In relation to the suggestion in the PDR that around 60 days the dosage of ethambutol be reduced, Dr. Parker believes that it is dependent upon the clinical response of the patient. Sometimes the dosage would be reduced earlier, sometimes later. The judgments concerning dosage would be that of the expert familiar with the MAI and drugs used to address it. SUMMARIZING FACTS: Respondent's explanation of the availability of the adult clinic in Ocala, Florida, to address Patient J.P.'s need for medications and other services only establishes that availability. It does not establish what was done at the clinic, if anything, in terms of treatment for MAI through the use of ethambutol and related vision tests. There is no proof that anything transpired at the adult clinic to treat MAI, or test for visual acuity. Whatever may have been offered to the patient in treatment and care by the adult clinic, it does not change the fact that Respondent and Dr. Prchal were involved with the treatment for MAI, to include the need to properly use ethambutol. Having considered the facts found concerning the care provided Patient J.P. by Respondent and Dr. Prchal and the opinions by the parties' experts Dr. Schoonover and Dr. Parker, Respondent has failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Dr. Prchal was responsible for prescribing ethambutol while Patient J.P. was in the hospital. Consequently Dr. Prchal was responsible for testing initial visual acuity for the patient. The initial treatment provided was upon a request to consult made by Respondent. Dr. Prchal was also responsible for establishing the initial dosage for the patient. When the patient was discharged from the hospital, Dr. Prchal was no longer responsible for the treatment from July 5, 2000, the discharge date until July 26, 2000, when called upon again by Respondent to consult. When Dr. Prchal saw Patient J.P. on July 26, 2000, and August 8, 2000, it reestablished his responsibility but only temporarily. The treatment was turned back to Respondent as established in the correspondence following the second consult. That correspondence was dated August 18, 2000, from Dr. Prchal to Respondent involving ethambutol and its use in treating Patient J.P. Respondent had responsibility for Patient J.P. in relation to ethambutol following the patient hospital discharge and upon the visit by Patient J.P. to Respondent's office on July 19, 2000. Respondent briefly deferred to Dr. Prchal as a consultant on July 26, 2000, until he received the correspondence from Dr. Prchal dated August 18, 2000. Beyond that point in time, Respondent was responsible for Patient J.P.'s use of the medication ethambutol. This responsibility was evidenced in the Respondent's transcribed office note dated October 23, 2000, when the Patient J.P. was seen on a follow-up visit. It refers to the final note from Dr. Prchal dated August 18, 2000 and the continuation of ethambutol for the patient. It describes the need for the patient to continue on ethambutol for a year or so. On December 27, 2000, when Patient J.P. was next seen by Respondent in the office, the patient complained of an eye problem. In response Respondent "stopped his ethambutol" as of that day. During the time that Respondent was responsible for Patient J.P., related to the use of ethambutol by that patient, he was expected to make a clinical judgment about the proper dosage, but not necessarily at a two-month interval. There is no indication that he made any judgment. More significantly, given allegations in the Administrative Complaint, Respondent should have arranged periodic testing of visual acuity, while he was responsible for the use of ethambutol in treating Patient J.P., having failed to reduce the dosage from 25 mg per kg of body weight. Respondent's failure to meet the standard of care is not excused by Dr. Prchal's conduct when treating Patient J.P. with ethambutol. Respondent's belief that Dr. Prchal was all together responsible for treating Patient J.P.'s MAI with ethambutol and other medications is not accepted, realizing that to some degree Respondent undertook the treatment whether capable or not. Finally, there was no proof in this record concerning the local Department of Health, adult clinic providing treatment to Patient J.P. for MAI, to include judgment about the dosage of ethambutol and test for visual acuity. Absent such proof the responsibility fell entirely to Respondent and Dr. Prchal at various times. Their stated assumptions concerning the role, if any, played by the Department of Health, adult clinic in treating Patient J.P. without proof are unavailing and create no defense for their conduct. DISCIPLINARY HISTORY In the case of Department of Health, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOH Case No. 1999-58979, a Final Order was entered. This Final Order was based upon a Recommended Order in Department of Health, Board of Medicine, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOAH Case No. 01-2069PL. The Final Order concluded that Respondent had violated Section 458.331(1)(m), Florida Statutes, pertaining to maintenance of patient records justifying a course of treatment for a patient. It imposed an administrative fine amounting to $5,000.00. Respondent was also reprimanded by the Board. (Petitioner's Exhibit No. 4)
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2000), imposing an administrative fine of $10,000.00, and issuing a written reprimand. DONE AND ENTERED this 25th day of February, 2005, 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 25th day of February, 2005. COPIES FURNISHED: Irving Levine, Esquire Judith Law, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 Post Office Box 2753 Orlando, Florida 32802-2753 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Based on all of the evidence, the following findings of fact are determined: Background At all times relevant hereto, respondent, Shafaat Ahmed, was licensed as a medical doctor by petitioner, Department of Professional Regulation, Board of Medicine (Board). When the events herein occurred, respondent was engaged in the practice of orthopedic medicine and surgery at 1121 Mason Avenue, Daytona Beach, Florida. He has been licensed by the Board since 1965. A native of India, respondent received a five-year medical degree from Agra University in Indore, India, in 1957 and came to the United States the following year. Thereafter, Dr. Ahmed received extensive post-medical school specialty training in this country and was board certified in orthopedic surgery in January 1969. He has been in private practice in Daytona Beach, Florida, since November 1965 specializing in orthopedic surgery. There is no evidence that respondent has been previously disciplined by the Board during his lengthy tenure as a physician. These proceedings have their origin in early 1991 when two former patients of respondent, both female, filed complaints with the Board alleging that respondent had engaged in sexual misconduct, that is, he had inappropriately touched them while they were being treated for various injuries. A news account of these two complaints was published in the Daytona Beach News Journal on March 13, 1991. As a result of that article, seven other former female patients came forward and lodged similar complaints against respondent. These complaints form the basis for the charges in Case Nos. 91-2366 and 91- 7577. However, the charges made by one patient (number 2) were voluntarily dismissed by petitioner at hearing. For purposes of preserving the confidentiality of the names of the patients, they will be referred to by their patient numbers 1, 3, 4, 5, 6, 7, 8 and 9, which correspond with their identification in the two complaints. The complaints generally involve allegations by the patients that while respondent was examining and treating them for various injuries suffered from accidents, he inappropriately touched their breasts and vaginal area and did so without using gloves. These alleged improprieties range in time from 1973 (or some 19 years ago) to as recent as 1989. All patients claim that the touchings were not incidental or unintentional but, rather, were deliberate and calculated acts on the part of respondent, an allegation strongly denied by respondent. To resolve these claims, it is necessary to judge not only the credibility of the patients and respondent and the supporting cast of witnesses for both sides but also to consider the appropriate manner in which orthopedic examinations are conducted and whether the complaints presented by the patients to respondent justified certain physical examinations. To aid in the resolution of the complaints, both parties presented numerous lay and expert witnesses. As might be expected, their testimony presents factual conflicts which have been resolved by the undersigned accepting the more credible and persuasive testimony. The accepted testimony is set forth in the following findings. Respondent's Practice Respondent has been in the private practice of orthopedics in Daytona Beach since September 1965. In all, he has probably treated more than 25,000 patients during his tenure in private practice. After initially working with several other orthopedic surgeons, Dr. Ahmed opened his own office in 1968 and has been a sole practitioner since that time. However, during the 1980's, an older, semi-retired orthopedic surgeon, Dr. Albee, assisted respondent on a part-time basis in seeing patients on follow-up office visits for symptomatic complaints. Prior to 1983, respondent carried an extremely heavy and active patient caseload. In 1983, respondent and a friend were struck by an automobile while crossing a street near respondent's home. The friend was killed while respondent suffered a skull fracture and three compression fractures in his dorsal spine. Because of these serious injuries, respondent was unable to return to his office for approximately three months. Even then, he was able to devote only a limited amount of time to office work since he was heavily dependent on crutches and braces. Since the accident, respondent has necessarily reduced his case load, and he has suffered a serious degree of impotence which bears on the validity of some allegations by patients that respondent had an erection when he pressed against them. Respondent's office has been located on Mason Avenue in Daytona Beach since around 1974. The office has a series of five small examination rooms, one of which is larger than the others and has been designated as the "cast room." All rooms have sliding doors. In addition, there is a therapy area, an x-ray facility, a waiting area and a business office. Each examination room has a standard medical examination table, step stool, chair, sink and cabinet. There is very little room for movement due to the small size of the rooms. Indeed, one witness stated that to get three persons abreast in the rooms would create a "very crowded" condition. Until late 1989, respondent did not have a female assistant remain in the examination room while female patients were being examined. This was because he had never received any complaints, doors were left partially open and assistants were only a few steps away. After a charge of impropriety was leveled against him that year by patient 1, he has always had a female assistant in the examination room while treating both male and female patients. It should be noted that respondent's failure to have a female assistant in the room was not unusual since this practice accorded with the community custom. Indeed, another Daytona Beach orthopedic surgeon who testified at hearing followed this same practice until he became aware of the charges leveled against respondent. At that time, the doctor hired a female assistant to stay with him in the examination room while treating female patients so as to avoid the possibility of similar charges. Like so many other medical offices, after entering respondent's office, a patient is required to put his name on a sign-in sheet. If the visit is the patient's first, the patient is also required to fill out a patient history form which is then immediately typed by the business office. Before the patient is sent to an examination room, Dr. Ahmed reviews the complaints to determine if x- rays are needed. If none are required, the patient goes to an examination room with his records. Since at least the early 1970's, respondent has had a practice of keeping the sliding doors in the examination rooms either entirely or partially open while meeting with the patient. This is because the patient is not disrobed, and respondent frequently calls to an assistant for information or assistance during the examination process. Because of the small dimensions of the rooms and their proximity to one another, and the fact that long waits for the doctor are not unusual, the patients often talk to each other through the open doors while waiting for respondent. The only exception to the open-door policy is in the cast room where the door is periodically shut by the cast- cutter to muffle the noise from the cast-cutting machine. The Appropriate Orthopedic Examination There is no concise description in the record of the type of injuries that an orthopedic surgeon treats. However, it may be inferred from the record that an orthopedic surgeon treats patients having injuries to the bones and ligaments of the body. The type of injury presented by a female patient generally dictates the type of examination given by the orthopedic surgeon. Where the patient has been involved in an autombile or a slip and fall accident, as was the case with almost every complaining patient here, it is customary in the medical community for the doctor to perform a complete and comprehensive examination. This includes, among other things, an examination of the chest wall, pelvic ring and hip joint. Although particular problems can sometimes be accurately diagnosed through the use of x-rays, a physical (hands-on) examination is still necessary in virtually every case. This is because the examinations have shown fractures, cartilage tears and dislocations that do not show up in x-rays. When an anterior-chest (the frontal portion of the chest) examination is performed, the examiner is required to inspect, palpate, percuss and feel the different areas of the chest wall, including the muscles and ligaments underlying the breast area. This is particularly true where the doctor must ascertain whether the patient has costochondritis, which is an inflammatory process in the rib/cartilage junction of the chest, or a costochondral separation. In examining this area of the body, it is essential for the examiner to touch on and around the patient's breasts. This touching is generally done with two or three of the fingertips placed together, and to the patient, it may appear the doctor is rubbing his fingers (hand) back and forth across the breasts while palpating the costochondral junctions in the chest. Another required test is the pelvic compression test. It is an accepted test for patients who have experienced a medical trauma such as injuries received in an automobile accident and who manifest pain in the lower back, leg, and inguinal areas or the sacroiliac. To perform the pelvic compression test, the doctor requires the patient to lay on her side (the decubitus position) while the examiner presses down on the hip (iliac crest region) to see if any discomfort or pain is elicited. The doctor also presses down and palpates the pubic bone area (or just above the vagina) to see if any pain occurs. Such a procedure is required to determine the integrity of the ligaments, the interpubic disc and the adjacent pubic bones. When performing this procedure, it is appropriate for the doctor to slide his hand under the patient's underwear while palpating the pubic bone, and the doctor's hand must necessarily touch the pubic hair of the patient. While the examination can be performed by pressing through the patient's clothing, which procedure respondent has occasionally used, the preferred and more reliable method is for the doctor to press the patient's bare skin. Incidental contact with the top of the vulva is not unusual and gloves are never worn. In those instances where the examiner is palpating the patient's back, it is an accepted procedure to place the examiner's other hand on the patient's chest as a steadying or balancing influence to keep the patient from swaying or being pushed over by the doctor. Depending on the doctor's position, this may entail placing the hand near or adjacent to the breast area and include incidental touching of the patient's breasts. If a patient presents a complaint of a possible hernia in the groin area and asks that it be checked, as did one patient in these proceedings, the examiner puts his hand on both sides of the inguinal region and asks the patient to turn her head and cough to see if a hernia protrudes or if a tear in the tissue is discerned. Obviously, it is not necessary for the examiner to stick his finger in the vagina in order to make this type of examination on a female patient. According to one surgeon who treats hernias on a regular basis, he requires female patients to disrobe (i.e., remove their undergarments) before conducting his examination. He says this is the only way in which the hernia can be properly examined and it necessitates, in some instances, incidental contact with the vaginal area. Moreover, it is not customary in the medical community to wear gloves during such an examination. This is because no entry into the vagina itself is necessary nor contemplated. This testimony was not contradicted. Respondent makes handwritten notes as a patient examination progresses and dictates the patient chart entries on the dictation machine in the examining room while the patient is there. He has a reputation among local attorneys and physicians as having accurate and reliable records. In addition, while performing his examinations, respondent typically wears a business suit and carries flashlights, pens, and goniometer, a beeper on his hip, and a percussion hammer in his pocket. The goniometer is made of hard plastic, about six inches long, is flat and bullet shaped, and was carried in respondent's right, front pants pocket. Respondent's Cultural Background Respondent was born on July 4, 1932, in Jaora, India, is a fourth generation physician, and is a devout Moslem. He received his medical degree and initial medical training from a university in that country. The evidence establishes that it is customary for physicians in India to never ask the patient for permission to touch them, and they do not explain to a patient why they are touching them in a certain area of the body. Respondent also had a habit, based upon Indian custom, of standing very close to a person when engaging that person in a conversation. Until these proceedings arose, respondent was not aware that this mannerism caused some persons to whom he was speaking to be uncomfortable. Finally, because of his Indian background and class cultural status, respondent does not find putting his finger into a vagina erotic or sexually stimulating. In every single case herein, respondent did not request permission from his patients prior to touching them during an examination. In addition, he did not explain to them why he was performing a frontal chest examination or a pelvic compression test, both of which require contact with sensitive areas of the body. Although this lack of communication may be disconcerting to some patients, it is not a ground for disciplinary action since such a practice does not constitute a deviation from the standard of care. As noted in a subsequent finding, after these practices were brought to his attention during an evaluation process by another physician, respondent began requesting permission to touch patients and advising them as to why certain examinations were being performed. Golden Valley Examination After the first complaints were filed against respondent, and after contacting Dr. Roger Goetz, who is medical director of the Florida Physician Recovery Network, in March 1991 respondent visited the Golden Valley Health Center (Golden Valley) in Minneapolis, Minnesota, a freestanding psychiatric hospital that specializes in the treatment of sexual disorders and psychiatric illness. The aim of the visit was to determine, among other things, whether respondent was afflicted with a sexual disorder or mental sexual deviancy problem. The Golden Valley medical coordinator is Dr. Richard Irons, a board certified internist. As a part of the Golden Valley evaluation process, respondent was required to perform a mock examination of Dr. Irons. The purpose of the examination was to enable Dr. Irons to compare respondent's examining techniques with the techniques used by other doctors. It was established that Dr. Ahmed felt comfortable with his body much more proximate to the patient than one would expect of an American doctor. However, this was consistent with his cultural background as a native of India. In addition, because of his rather short arms, it was necessary for respondent to move physically closer to the patient in order to perform the type of examination typically required by an orthopedic physician. Doctor Irons then examined Dr. Ahmed using respondent's examining techniques. The examiner noticed that respondent was genuinely surprised how close the examiner's body came to his and felt uncomfortable when Dr. Irons' pelvic and genital areas came in contact with his body. Finally, Dr. Irons learned that Dr. Ahmed did not know that it was comforting to ask the patient permission to touch their bodies since Indian doctors do not ask permission to touch their patients. After a week of psychological testing, the consensus of the Golden Valley staff was that respondent did not have a psychosexual disorder or mental sexual deviancy problem. This conclusion was also reached by Dr. Jack Rotstein, a Daytona Beach psychiatrist, who performed a comprehensive psychiatric examination of respondent in 1990 and found no evidence of any mental or sexual disorder. The Golden Valley group also recommended that respondent seek medical attention for impotence to determine how serious that problem was since respondent has experienced such problems since his injuries received when struck by an automobile in 1983. Respondent has complied with this recommendation. The Complaints of the Patients Generally With the foregoing factual background in mind, the complaints will be reviewed and analyzed. All were made by former female patients of respondent, the most recent complaint having its origin some three years ago. Some of the complaints were based on treatment performed a decade or longer ago while one dates back almost twenty years. At the time of hearing, three of the patients had lawsuits pending while at least one other was considering filing a suit. It is noted that none of the patients complained that respondent made sexually suggestive remarks or otherwise acted (except in the touchings) in a sexually suggestive manner. Finally, it is again important to note that, unlike many doctors, respondent never explained to the patients why it was necessary to touch their breasts and pubic bone areas. Patient 1 The underlying allegations in the amended complaint concerning patient 1 were that, during an office visit on March 6, 1989, respondent "ran his finger across (her) nipple repeatedly, rested his hand on (her) left breast and squeezed it, put his finger inside (her) vagina; and hugged (her) with an erection", all such acts constituting "sexual activity outside the scope of generally accepted examination or treatment of the patient." Patient 1 is a thirty-nine year old female who was first treated by respondent in 1985 for injuries sustained in an automobile accident. She chose him by random out of the telephone book. Although she had no problems during these visits, she recalled that respondent got very close to her face when he spoke to her and this made her a little "uncomfortable." In 1988 patient 1 was in a second automobile accident and suffered injuries to her face, neck, ear and jaw. She was again treated by respondent. After conducting a physical examination on the first visit, respondent prescribed physical therapy. On a subsequent visit on March 6, 1989, patient 1 told respondent that she suspected she had a hernia in her left groin area adjacent to her vagina and asked him to check the area. Respondent observed a lump in the left groin area, palpated it and found it to be "moveable". Since he believed it to be a femoral hernia he recommended she see a general surgeon for treatment. Standard medical procedure also called for respondent to check the right groin area of the patient. He found no lumps on the right side. While examining the two groin areas, there was incidental contact with the side of the patient's vaginal area but such contact was incidental and without sexual connotation. Testimony that respondent placed his finger inside her vagina, squeezed her left breast, ran his finger over her nipple, and pressed against her body with an erection is not accepted as being credible. In discrediting this patient's testimony, the undersigned has considered the fact that patient 1 has a pending lawsuit against respondent and a reputation for not telling the truth. She has also filed other lawsuits and unfounded claims in the past and gave testimony which was inconsistent in several respects. Patient 3 The amended complaint alleges that while treating patient 3 in the fall of 1987, respondent "commented to (her) that she had a nice body and pretty hair," he "placed his hand on one of her breasts and stroked her nipple and then stroked her genital area while pressing his body against hers." Patient 3 was first treated by respondent in 1973 for injuries received in a motorcycle accident. On July 8, 1987, she was struck by an automobile while riding a bicycle. This occasioned a series of visits to respondent's office for treatment. At that time, she presented complaints of pain in the neck, middle back, lower back and tailbone area, numbness and headaches, which necessitated respondent administering a comprehensive orthopedic examination, including a pelvic compression test. It is noted that the patient's recollection of her treatment did not comport with her medical records, as contemporaneously recorded in 1987. Although the patient alleged that on one visit respondent "stroked" her clitoris four or five times from the outside of her pants and undergarments, this assertion is not deemed to be credible. Likewise, the testimony that respondent complimented her on having a nice body and pretty hair is discredited. Further, the patient was confused as to which breast respondent allegedly touched, and if such touching occurred, it was incidental to an appropriate examination. Finally, her contention that she reported these incidents to two of respondent's employees was denied by those employees. Therefore, it is found that no inappropriate touchings occurred with respect to this patient. Patient 4 The amended complaint alleges that while treating patient 4 on two office visits in December 1982, respondent "rubbed his hand across (her) bra". On another visit in January 1983 respondent allegedly stood behind the patient, had her bend over to touch her toes, and pressed his body against her while she bent over. It also alleges that on the same office visit, respondent had the patient lie down on the examination table, unzipped her pants and placed his hand inside her undergarments. Patient 4, who is the sister of patient 9, was in an automobile accident on October 24, 1982, and was later admitted to a local hospital where respondent first saw her on November 1, 1982. A local attorney had recommended that the patient see respondent for treatment. The patient made a number of follow-up visits to respondent's office during the following months. It is noted that at hearing the patient had hardly any recollection of the information recorded in her medical records regarding tests performed, injuries diagnosed or verbal complaints she gave to respondent. At hearing, the patient complained that during at least two office visits in December 1982 or January 1983 respondent's hand touched her breast during the course of the examination. While such an occurrence probably happened when respondent placed his hand in the sternum area while pressing with the other hand on her back or while checking her complaint of tightness in the sternocleidomastoid, it was incidental and had no sexual connotations. On another visit, and while performing a range of motion test which required her to bend forward, patient 4 recalled that respondent stood behind her and placed his arms around her waist while having her bend over causing her body to press against his groin area. However, the more credible fact is that respondent stood closely to the side of the patient while she bent over and there may have been incidental touching with his body. There were no sexual connotations in this touching. Finally, although the patient recalled that respondent placed her in a lying position on the table and began pressing down in her abdominal area, assuming the patient's recollection is correct, there was nothing inappropriate in this action since an examination of this area was appropriate. Therefore, it is found that the allegations involving patient 4 have not been sustained. Patient 5 As to this patient, the amended complaint alleges that while treating her in September 1977, or some fifteen years ago, respondent "placed his hand inside the front of her pants and undergarments and placed his hand on (her) pubic area of her vaginal lips," and then later told her three year old son "that he had a beautiful mommy." In September 1977 the truck in which patient 5 was a passenger was struck by an automobile. She suffered back injuries and lacerations to her leg. Upon the advice of her attorney she sought treatment from respondent. During respondent's examination of the patient, the patient's three year old son, who had also been injured in the accident, remained in the examination room. As respondent performed a pelvic compression test on the patient, she recalled that his hand went inside her slacks and underwear and slid down to the pubic bone area where he pressed to discern any discomfort. There was momentary (two seconds or less) incidental touching of the upper part of the vulva and then respondent withdrew his hand. Because the patient had never had that type of examination performed before, and received no explanation as to why it was needed, she felt it was inappropriate and sexual in nature. However, it is found that the touching of the upper part of the vulva was incidental to the pelvic compression test and had no sexual connotations. After respondent completed his examination of the patient, he examined the three year old son in her presence. In order to put the child at ease, respondent engaged in conversation with the child and, among other things, said words to the effect that he had a pretty mommy. The patient acknowledged at hearing that she did not find the comments to be "offensive" and it is found that such comments were not inappropriate or sexually suggestive. Patient 6 This allegation dates back to January 1973 and involves a charge that while respondent was treating this patient for pain caused by job-related injuries he "inserted his finger into her vagina". It is noted that the patient continued being treated by respondent until August 1974. The patient is now contemplating filing a civil action against respondent. According to respondent's records, on the patient's first office visit he examined her pubic bone to check the arcuate ligament which is shaped like an arc at the bottom of the pubic bone. An injury in this area could produce pain in the patient's lower back and legs. The patient recalls that respondent did not state why the examination was necessary, ask permission to touch her body, or ask her if that area hurt. Although the witness believed that she felt one or two fingers being inserted into her vagina during the test, it is found that no insertion occurred but there was incidental contact with her vagina associated with the pelvic compression test. Therefore, it is found that no improper conduct occurred with respect to this patient. Patient 7 The charges underlying the treatment of this patient are that during several office vists between April 1986 and December 1987 respondent "rubbed (her) breasts", "rubbed his pelvic area against (her) knee", "had (her) lay down on the examination table, unbuttoned and unzipped her pants and placed one of his fingers in her vagina." It is also alleged that he "kissed (her) on the lips." In evaluating the credibility of this complaint, it is noted that the patient was addicted to pain medications while being treated by respondent, and she became "angry" when he put her on a decreasing dosage schedule on her last visit. This patient was treated for trauma related to an amusement park ride injury and a rear end autombile accident which resulted in back and neck pain. She recalled two, or maybe three, unspecified improper touchings by respondent on undisclosed dates. Two such touchings were of her breasts, but these are found to have occurred while respondent performed a chest examination and were not inappropriate. While performing a pelvic compression test, and after specifically recalling that respondent had first pressed her hip bones, the patient remembers that he slid his hand down to her pubic bone and began pressing. If there was contact by respondent's hand with the upper part of the patient's vulva, it is found to be incidental. Finally, the patient recalled that after undergoing surgery, respondent kissed her on the lips as she left the office, but she construed it as a fatherly kiss with no sexual overtones, said that respondent "meant (nothing) by it", and she was in no way offended by this fatherly gesture. Accordingly, it is found that no improper conduct occurred. Patient 8 As to this patient, the amended complaint alleges that on several office visits between June 6, 1988, and October 3, 1988, respondent "would place his hand over (her) breasts" in a manner which was not consistent with acceptable physical examinations. On May 31, 1988, patient 8 was thrown from a motorcycle, landing on her side with sufficient impact to break bones, including her collar bone, and be hospitalized. Respondent first saw the patient at the hospital, and she visited his office for a number of follow-up visits. Until she read the newspaper article concerning patients 1 and 2, she assumed she had been treated appropriately. She now intends to file a civil action against respondent. Patient 8 originally believed that respondent was examining her for a hernia when he performed a pelvic compression test. She now understands that the pelvic compression test was an appropriate procedure. Although not an allegation in the complaint, the patient recalled that when the test was performed while she was lying in bed in the hospital, respondent's hand touched the top of her vagina. If such touching occurred, it was incidental to the test and was not inappropriate. The patient also recalled that on "several" occasions during the office visits, respondent's hand touched her right breast. To the extent such touchings may have occurred, it is found that they were incidental to other appropriate examinations and had no sexual overtones. Patient 9 The allegations concerning the final patient are that during an examination on August 17, 1989, respondent "placed his hands on the patient's breasts and squeezed them", and while standing behind her, he had her "bend over forward, and pressed his body against the body of (the) patient." The complaint also alleges that during a subsequent examination, respondent "rubbed (her) groin area through her pants" and stopped after the patient advised him she did not have pain in that area. She has recently filed a civil lawsuit against respondent. This patient sought treatment from respondent for injuries received from a slip and fall accident. During the course of her treatment, the medical records show the patient's chest wall was examined which would necessitate the incidental touchings of her breasts. Respondent also performed a forward flexion test which required him to stand to her side to observe her flexion. Any bodily contact between the two during that test was incidental and non- sexual in nature. Finally, the touching of the groin area occurred during a pelvic compression test and was an appropriate procedure given the injuries and pain presented by the patient. Prior to performing that test, respondent did not explain to the patient what he was doing or why it was necessary. At hearing she stated that had he explained the necessity of such a test, she probably would not have complained. Therefore, it is found that no improper conduct occurred. i. Summary In summary, it is found that respondent did not touch the eight patients in an inappropriate manner and that he followed all routine orthopedic examination procedures while examining his patients. To the extent such touchings of the breast and vaginal areas occurred, these were incidental to medically necessary tests. In making these findings, the undersigned has considered the statements made by some of the patients to friends, family members and others concerning the alleged inappropriate touchings, and which hearsay testimony was offered to supplement and explain the patients' testimony. Although such statements were presumably made, they are found to be based upon the patients' misunderstanding of orthopedic tests, a lack of communication between respondent and his patients, and the patients' erroneous perception that such touchings were not medically necessary. The undersigned has also considered the testimony of petitioner's experts, Drs. Zeide and Barnard, but their conclusions are based upon the assumption that all of the complaints were true. Therefore, it is found that respondent did not exercise influence within his patient-physician relationship for the purpose of engaging his patients in sexual activities.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent enter a final order dismissing the two administrative complaints, with prejudice. DONE AND ORDERED in Tallahassee, Florida, this 28th day of September, 1992. DONALD R. ALEXANDER 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 28th day of September, 1992. Petitioner: APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 91-2366 and 91-7577 1-3. Partially accepted in finding of fact 1. 4-35. Partially accepted in findings of fact 25-28 and 46. 36. Partially accepted in finding of fact 2. 37-45. Partially accepted in findings of fact 29 and 30. 46-56. Partially accepted in findings of fact 31-33 and 46. 57-67. Partially accepted in findings of fact 33-36 and 46. 68-76. Partially accepted in findings of fact 37, 38 and 46. 77-85. Partially accepted in findings of fact 39, 40 and 46. 86-95. Partially accepted in findings of fact 41-43 and 46. 96-103. Partially accepted in findings of fact 44-46. Respondent: 1. Partially accepted in finding of fact 2. 2-4. Partially accepted in finding of fact 8. 5-7. Partially accepted in findings of fact 2 and 24. 8-11. Partially accepted in findings of fact 2, 5 and 6. 12-13. Partially accepted in findings of fact 7, 9 and 10. 14. Partially accepted in finding of fact 17. 15. Partially accepted in finding of fact 5. 16. Partially accepted in findings of fact 12-14. 17. Partially accepted in finding of fact 46. 18. Partially accepted in findings of fact 12 and 14. 19. Partially accepted in finding of fact 17. 20-22. Partially accepted in findings of fact 13 and 14. 23. Partially accepted in finding of fact 24. 24-25. Rejected as being unnecessary. 26-44. Partially accepted in findings of fact 25-28. 45. Partially accepted in finding of fact 2. 46-60. Partially accepted in findings of fact 29, 30 and 46. 61-67. Partially accepted in findings of fact 31-33 and 46. 68-81. Partially accepted in findings of fact 34-36 and 46. 82-94. Partially accepted in findings of fact 37, 38 and 46. 95-104. Partially accepted in findings of fact 39, 40 and 46. 105-112. Partially accepted in findings of fact 41-43 and 46. 113-124. Partially accepted in findings of fact 44-46. 125-141. Partially accepted in findings of fact 47-49. NOTE: Where a proposed finding has been partially accepted, the remainder has been rejected as being irrelevant, unnecessary, subordinate, not supported by the more credible and persuasive testimony, or a conclusion of law. COPIES FURNISHED: Bruce D. Lamb, Esquire Post Office Box 2378 Tampa, Florida 33601 Larry G. McPherson, Jr., Esquire 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 James W. Smith, Esquire Todd M. Cranshaw, Esquire 214 Loomis Avenue Daytona Beach, Florida 32114 Paul Watson Lambert, Esquire 2851 Remington Green Circle Suite C Tallahassee, Florida 32308 Dorothy J. Faircloth, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jack L. McRay, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792
The Issue Whether Respondent performed a wrong-site procedure in violation of section 456.072(1)(bb), Florida Statutes; if so, whether (and what) disciplinary measures should be taken against Respondent's license to practice medicine.
Findings Of Fact At all times relevant to this case, Dr. Lior, M.D., was licensed to practice medicine in the State of Florida, having been issued license number ME 74061, and was board-certified by the American Board of Dermatology. The Department has regulatory jurisdiction over licensed physicians such as Dr. Lior. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Lior committed one such offense. In the one-count Complaint, the Department charges that Dr. Lior violated section 456.072(1)(bb), "by performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition." Dr. Akhtar's Examination On January 11, 2010, Patient S.L., a 74-year-old gentleman, presented to Asfa Akhtar, D.O., a general dermatologist employed by the Cleveland Clinic Florida, for an evaluation of a lesion inside his left ear. It was noted on that date that S.L. had a positive history for skin cancer. Dr. Akhtar performed a physical examination of S.L., and his contemporaneous note provides, in pertinent part, as follows: "Exam of the face, ears and hands reveal a pearly papule with rolled borders on the right helix."1/ On that date Dr. Akhtar's assessment included "R/O BCC-right helix." In other words, Dr. Akhtar wanted to rule out basal cell carcinoma on S.L.'s right helix. Dr. Akhtar's plan was to conduct a "shave biopsy." Prior to performing the biopsy, the location was marked with a pen and photographed. Dr. Akhtar then performed the biopsy by scraping skin cells of the surface skin of the suspicious area. The subsequent surgical pathology report provides, in pertinent part, as follows: Final Pathologic Diagnosis SKIN BIOPSY, RIGHT HELIX: NODULAR BASAL CELL CARCINOMA WITH SURFACE ULCERATION. TUMOR EXTENDS TO THE DEEP AND PERIPHERAL MARGINS OF BIOPSY. In correspondence dated January 20, 2010, Dr. Akhtar advised S.L. that the pathologic findings from the biopsy specimen of S.L.'s right helix confirmed a basal cell carcinoma. Dr. Akhtar recommended that it "be treated by a technique called Mohs Surgery to be certain as possible that it is completely removed." January 26, 2010 Consultation On January 26, 2010, S.L. presented to Dr. Lior for a Mohs surgical consultation. In addition to being board-certified in dermatology, Dr. Lior is qualified as a Mohs surgeon. On that date, Dr. Lior, who is also employed at the Cleveland Clinic, had access to the records of Dr. Aktar's office visit, the biopsy photograph, and the pathology report. Additionally, Dr. Lior's nurse, Diane Donner, LPN, obtained additional history from the patient. Specifically, Ms. Donner noted that, "[p]atient states he has surgery in the area approximately 3 years ago. It has been present for 3 YEAR(S)." Dr. Lior then performed an examination of S.L.'s right helix; however, her examination did not include the entire right helix. Specifically, Dr. Lior did not examine the top of the helix of S.L.'s ear. Instead, Dr. Lior conducted a "focused examination" on an observed scarred pearly papule on the helix of the right ear just superior to (above) the mid-line of the ear. Dr. Lior explained the methodology utilized in limiting her examination to a specific location on the helix, as follows: Q. . . . What information from those records would indicate where on that right helix that you just described that either the biopsy was taken or that there was biopsy- proven carcinoma? A. Right. So when we get that information, patient participation is expected. We ask the patient. We get a history. Then we also need to look at the area and see what looks consistent with the biopsy site as well. And so all of these things, when you actually see a cancer and you see a scar and you see the skin graft area, and the patient tells you that that's the site, you put it together with your biopsy pathology report, as well as your office notes. It's what we use all together. Based on Dr. Lior's experience, the observed papule was consistent with the clinical appearance of basal cell carcinoma. Dr. Lior credibly testified that S.L. pointed to the same area she was palpating and advised her that he had previously undergone Mohs surgery and that the cancer had returned. Dr. Lior discussed treatment options with S.L. and advised that Mohs surgery would be appropriate, to which S.L. agreed. Dr. Lior's record of the consultation provides in pertinent part, as follows: Physical Exam: Right superior helix: There is a 1 cm scarred, crusted, pearly papule. Impression: Biopsy-proven basal cell carcinoma. Patient notes this is recurrent. Plan: Therefore indicated for Mohs surgery. February 11, 2010 Mohs Surgery S.L. returned to Dr. Lior for the scheduled Mohs surgery on February 11, 2010. Upon entering the surgical room, S.L. was engaged in a conversation with Ms. Donner concerning the location of the site. Dr. Lior greeted and approached S.L., obtained the prior photograph, approached S.L.'s ear, and stated, "let's take a look." As she was attempting to match the photograph with the area of the ear, S.L. stated to Dr. Lior, "Don't you see the scar?" while simultaneously pointing to the location of the scar tissue. Dr. Lior indeed observed the scar tissue from the prior skin graft and again, like the January 26, 2010, consultation, noted the area was consistent with recurrent basal cell carcinoma. The location was noted to be just above the scar. Dr. Lior proceeded to palpate or touch the suspicious area. Thereafter, Dr. Lior proceeded to mark the intended surgical location on S.L.'s ear with a marker pen. Subsequently, a photograph of the marked location was obtained, the patient's informed consent was obtained, and an informed consent document was executed by S.L. A time-out was then performed where Dr. Lior and her assistant agreed upon the procedure and location. The surgical site was then sterilized and injected with lidocaine. At no time prior to the surgery did S.L. voice any concerns or objections related to the proposed surgical site. S.L. was not, however, provided a mirror to examine the proposed marked location. Additionally, there was no evidence that S.L. was shown a copy of the photograph obtained by Dr. Lior prior to surgery. Dr. Lior then proceeded to perform the Mohs surgery without incident. After completing the procedure, S.L.'s ear was bandaged and S.L. waited in a separate room while the excised portion of the ear was examined to determine whether there were "clear margins"--the absence of basal cell carcinoma. After completing the examination, Dr. Lior requested that S.L. return to the operating area to discuss the findings. When S.L. returned, Dr. Lior stated, "Good news, it's all clear, the margins are clear, there's no cancer, we're going to repair the area." In response, S.L. replied that, "[t]he site was not here, it was here." S.L. then bent the top of his ear down, and Dr. Lior observed--for the first time--a papule consistent with basal cell carcinoma.2/ It is undisputed that this newly-observed papule was the site of biopsy-proven basal cell carcinoma. Dr. Lior conceded that it was her plan, at the conclusion of the January 26, 2010, consultation, to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. She further conceded that, on February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix different from the location that was the subject of the biopsy performed by Dr. Akhtar.3/ Dr. Lior offered to perform a Mohs surgery on the newly-observed/previously-biopsied location; however, S.L. elected to defer the procedure for a later date. Accordingly, Dr. Lior closed the existing excision site and performed a skin graft in the area. Dr. Lior provided S.L. with her contact information and informed S.L. that she would attempt to arrange for the Cleveland Clinic to withhold the charges for the surgical procedure performed. The Cleveland Clinic reversed the charges, as requested. S.L. declined to return to the Cleveland Clinic for suture removal or for any additional procedures.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of performing a wrong-site procedure and, therefore, violating section 456.072(1)(bb); and imposing the following penalties: a $1,000.00 fine, a letter of concern, five hours of risk management education, and a one-hour lecture on wrong-site surgery. DONE AND ENTERED this 20th day of May, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE 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 20th day of May, 2013.
The Issue Whether Respondent, a medical doctor, violated Section 458.331(1)(m), Florida Statutes, as alleged in Count I of the Administrative Complaint and, if so, the penalty or penalties that should be imposed. Whether Respondent violated Section 458.331(1)(t), Florida Statutes, as alleged in Count II of the Administrative Complaint, and, if so, the penalty or penalties that should be imposed.
Findings Of Fact Effective July 1, 1997, Petitioner is the agency of the State of Florida charged with regulating the practice of medicine pursuant to Section 20.34, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Pursuant to the provisions of Section 20.43(3), Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide investigative and prosecutorial services required by the Division of Medical Assurance, councils, or boards, as appropriate. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0053773. Respondent has been board-certified in radiology since 1989. In 1995, at the time of the screening mammogram at issue in this proceeding, Respondent was a radiologist at Fisherman's Hospital in the Florida Keys. At the times pertinent to this proceeding, Respondent and Fisherman's Hospital used a classification system to describe the results of mammograms. That classification, developed by the American College of Radiology in 1992, is referred to as BI-RADS, which is an acronym for Breast Imaging Reporting and Data System. The following six categories are used: Category 0: Need Additional Imaging Evaluation: Finding for which additional imaging evaluation is needed. This is almost always used in a screening situation and should rarely be used after a full imaging work up. A recommendation for additional imaging evaluation includes the use of spot compression, magnification, special mammography views, ultrasound, etc. Category 1: Negative: There is nothing to comment on. The breasts are symmetrical and no masses, architectural disturbances or suspicious calcifications are present. Category 2: Benign Finding: This is also a negative mammogram but the interpreter may wish to describe a finding. The interpreter might wish to describe findings while still concluding that there is no mammography evidence of malignancy. Category 3: Probably Benign Finding - Short Interval Follow-Up Suggested: A finding placed in this category should have a very high probability of being benign. It is not expected to change over the follow-up interval, but the radiologist would prefer to establish its stability. Data are becoming available that shed light on the efficacy of short interval follow-up. Category 4: Suspicious Abnormality - Biopsy Should Be Considered: There are lesions that do not have the characteristic morphologies of breast cancer, but have a definite probability of being malignant. The radiologist has sufficient concern to urge a biopsy. Category 5: Highly Suggestive of Malignancy - Appropriate Action Should Be taken: These lesions have a high probability of being cancer. On August 10, 1994, Dr. Sheldon Kushner referred his patient, P. D., to Fisherman's Hospital for a routine screening mammogram. The mammogram was interpreted by Dr. Wayne Moccia, a radiologist. Dr. Moccia's report reflected a dense fibroglandular pattern and scattered microcalcifications in both breasts. No masses or densities were identified. Dr. Moccia recommended a follow-up mammogram in six months for comparison if no prior mammogram was available. On July 21, 1995, Dr. Kushner referred P. D. to Fisherman's Hospital for a follow-up screening mammogram. Respondent was the radiologist who directed the taking of the mammogram views and subsequently interpreted them. Respondent performed two standard screening mammogram views for each breast - the cranial caudial view and the medial lateral oblique view. There is no allegation that these views were inappropriate. Respondent compared the results of the July 1995 mammogram to the results of the August 1994 mammogram and thereafter prepared a report, dated July 21, 1995. 2/ Respondent's report reflects that routine bilateral mammogram views were taken of the patient. The following reflects Respondent's findings: Comparison is from 8-10-94. There are several small clusters of calcifications, particularly in the left breast. The overall breast parenchymal density is increased, as before. No discrete mass. No change in the morphology of the calcifications. Under the part of the report marked "Conclusion", the following appears: Stable calcifications. As some of these are indeterminate in morphology, I would recommend a bilateral follow-up in one additional year to ensure continued stability. (Category 3). The reference to Category 3 is to the BI-RADS classification. According to Dr. Kushner's records, which were admitted into evidence without objection, P. D. was examined by Dr. Kushner on July 27, 1995. Dr. Kushner found P. D.'s breast examination to be within normal limits. P. D. returned to Fisherman's Hospital for a screening mammogram on August 14, 1996. At that time, Dr. Moccia compared the mammogram view taken on that date with the mammogram views taken August 1994 and July 1995. Dr. Moccia detected abnormalities which led him to conclude that there was a strong suspicion for malignancy of P. D.'s left breast. Dr. Moccia classified the 1996 mammogram as a Category 5 and recommended a biopsy. It was subsequently determined that P. D. had cancer in her left breast. There was a conflict in the evidence as to whether Respondent's interpretation of P. D.'s 1995 mammogram fell below the standard of care. Dr. Fueredi, Petitioner's expert, testified that Respondent's interpretation was below the standard of care and explained his reasons for his opinions. Dr. Foley, Respondent's expert, testified that Respondent's interpretation did not fall below the standard of care and explained his reasons for his opinions. Both of these experts are found to be highly qualified, and the testimony of each expert on this issue is found to be credible. There is no basis to credit Dr. Fueredi's testimony over that of Dr. Foley, or vice-versa. Petitioner failed to prove by clear and convincing evidence that Respondent failed to meet the standard of care in classifying P. D.'s July 1995 mammograms as BI-RADS Category 3. Petitioner also failed to establish by clear and convincing evidence that Respondent should have ordered immediate further testing for P. D. BI-RADS Category 3 suggests a short interval follow- up, without defining what constitutes a short interval. Again there was a conflict in the evidence as to whether Respondent's recommendation that P. D. be re-examined in a year fell below the standard of care. Dr. Fueredi testified that the interval for recommended follow-up should have been four to six months, and that Respondent's recommendation for a one-year follow-up fell below the standard of care. Dr. Foley testified that it was acceptable for Respondent to recommend the one-year follow- up. Both of these experts gave lengthy explanations for their opinions. Respondent's testimony as to this issue was conflicting. In his deposition testimony, Respondent testified that he intended to classify the mammogram as Category 3 BI- RADS, which meant to him that there should be a six-month follow-up. In his deposition, Respondent also testified that a recommendation for a one-year follow-up was inconsistent with a Category 3 classification. At the final hearing, Respondent testified that he was confused in his deposition, and that he intended to recommend a one-year follow-up because he knew that Dr. Kushner usually ordered mammograms for patients in P. D.'s age group every two years. This self-serving testimony given by Respondent at the final hearing lacks credibility and is rejected. Dr. Foley and Respondent (at the final hearing) did not convincingly explain how a normal follow-up interval for P. D. could also be appropriately considered to be an appropriate short interval follow-up within the meaning of BI- RADS Category 3. Respondent's deposition testimony that a recommendation for a one-year follow-up is inconsistent with a Category 3 classification is much more persuasive than his testimony on that issue at the final hearing. In resolving the conflicting testimony on this issue, the undersigned has concluded that Respondent's report contains an inconsistency which creates confusion as to the appropriate follow-up interval. The report fails to clearly reflect Respondent's examination results and recommendations for P. D.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order adopting the findings and conclusions contained in this Recommended Order. For the violation of Section 458.331(1)(m), Florida Statutes, it is recommended that Respondent be assessed an administrative fine in the amount of $500.00. DONE AND ENTERED this 14th day of November, 2000, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 November, 2000.
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2010.
