The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Carl Fromhagen, M.D., based on allegations that he violated Subsections 458.331(l)(k),(m) and (t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the following findings of facts are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1956 and issued License No. ME 0007027. Respondent is board-certified in Obstetrics and Gynecology (1967). He is 74 years old and now has an office- based practice treating only gynecological patients. Patient K. B., a 46-year-old female, first presented to Respondent on September 6, 1990, with menopausal complaints. Her patient's history reflects that she reported a family history of breast cancer. On February 12, 1992, Patient K. B. presented to Respondent with complaints of a mass in her left breast. Respondent palpated a mass in K. B.'s left breast and, although he did not note the size of the mass in his office records, the records contain a diagram showing the location of the mass. Petitioner testified that it was his practice that when he discovered a mass of less than 2.5 centimeters, he did not describe the size because its too hard to identify the exact dimensions smaller than an inch. Respondent ordered a mammogram for Patient K. B. which was performed on February 19, 1992, and was interpreted as revealing no evident neoplasm (cancer). Respondent saw Patient K. B. in his office on the following dates (after the mammogram): March 30, 1992; May 21, 1992; August 31, 1992; April 19, 1993; April 27, 1993; May 4, 1993; May 11, 1993; May 18, 1993; September 21, 1993; and November 16, 1993. In addition, Patient K. B. had telephone contact with Respondent's office staff to have prescriptions refilled and was mailed examination reminder notes. Patient K. B. testified that she and Dr. Fromhagen discussed the breast mass "every checkup, every time I was there." She inquired about a follow-up mammogram and Dr. Fromhagen indicated that she could wait two years. He did not mention a biopsy, excision, or referral to another physician at anytime. Patient K. B. and Respondent agree that Respondent examined and palpated the breast mass during her physical examinations which took place approximately every six months. During civil litigation that preceded the instant administrative hearing, it became apparent that there were two different sets of office records for Patient K. B. Patient K. B. testified that during the civil action she brought against Respondent in 1996, Respondent had produced medical records, purported to be hers that did not accurately reflect her treatment. She recalled that upon comparing the medical records Respondent had produced in the civil action with the records she had obtained from Respondent's office in December 1994, she discovered that Respondent had "augmented" her records, which she reported to her attorney. In May 1994, the offices of Dr. Paul Straub, who became Patient K. B.'s new treating physician as a result of a change in her group health insurance, requested her medical records from Dr. Fromhagen's office. Dr. Fromhagen testified in the instant hearing that "at the time . . . I compared the chart [Patient K. B.'s records] with . . . 'day sheets' and because I felt the records did not reveal everything that Dr. Straub should be aware of, I rewrote certain portions of them to reflect things that were on the day sheets that I hadn't already written down and then [in May 1994] sent the records to Dr. Straub." Patient K. B. testified that, "the night before my surgery" [December 1994] she received a call from Dr. Fromhagen's office asking if they could send her records to Dr. Straub. In the course of that discussion, Patient K. B. advised that she had been diagnosed with breast cancer and was scheduled for surgery. That same evening, shortly after the phone discussion with Dr. Fromhagen's office, Patient K. B. went to Dr. Fromhagen's office and obtained a copy of her medical records. These records did not contain the "rewritten portions" Dr. Fromhagen reported as having been done in May 1994. Dr. Fromhagen testified that he started keeping "day sheets" when he first started practicing in 1960. The "day sheets" (Respondent's Exhibit 2) are essentially a daily calendar organized by time which lists the name of patients to be seen that day and then notes such as "ovarin cyst," "vaginitis," "preg?" These "day sheets" were not mentioned in either of Dr. Fromhagen's depositions taken in 1996 in the civil action. In Petitioner's Exhibit 10, a July 3, 1997, letter to M. S. Sutton, an Agency for Health Care Administration investigator, Dr. Fromhagen attempts to explain his record- keeping practice for patients, Dr. Fromhagen acknowledges rewriting his charts and states, "I would carefully review the chart and address any portions that I felt were not completely explanatory, or that I thought need information to assist the subsequent physician. I now understand that I should have noted the changes as late entries and dated them the date written." No mention was made of "day sheets" in this letter. Dr. Fromhagen testified during a deposition taken in the civil action that his standard practice was "to make entries in the chart right away," that he never put it off, and that he had not done anything different in Patient K. B.'s case. Dr. Fromhagen acknowledged that during a deposition taken in the civil action he had incorrectly testified that he had not made changes in Patient K. B.'s medical record. The following is a comparison of the significant difference between Petitioner's Exhibit 9, Patient K. B.'s original medical record, and Respondent's Exhibit 3, Patient K. B.'s "augmented" medical record. Please note: Patient K. B. became Dr. Fromhagen's patient on September 6, 1990. No changes were made in the "Gynecologic History and Physical Examination" (Patient K. B.'s medical record) on any entry until March 30, 1992. Changes are highlighted. Date: March 30, 1992 Original record: "Mammogram was neg. palpation indicates mass much smaller. Will follow" Augmented record: "Mammogram reported as no evidence of neoplasm. Palpation indicates to me that mass is smaller. Discussed removing it" Date: May 21, 1992 Original record: "Dysuria General Malaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Augmented record: "Dysuria. Mailaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Date: August 31, 1992 Original record: "Introital lesions. Pelvic area feels congestion and cramping sensation. Pelvic- ulcers-blisters at introitus but very small. Herpes? Rx Zoirax" Augmented record: "Introital lesions. Lower abd cramping. Pelvic - herpetic ulcers at introitus. Rx Ziorax" Date: April 19, 1993 Original record: "Last mammogram revealed no concern. Dysuria. Frequent UTI. Had a cysto before. Rhinorrhea. Vulvar irritation. GenPE. Breasts unchanged. Pelvic - fungus. Rx She has Monistat. Urine - pus Macrodantin. RV Cysto" Augmented record: "Last mammogram revealed no neoplasm but mass still present and I suggested another x-ray now or removal of mass if she wishes. Dysuria. Has frequent UTIs. Had a Cysto before. Rhinorrhea. Vulvar irritation. Gen PE - nasal turbinates swollen. Breasts unchanged. Pelvic-fungus. Rx she has Monistat for fungus. Macrodantin RV Cysto" Date: April 27, 1993 Original record: "Cysto: stricutre. Proximal urethra & trizone inflamed and granules. Bladder capacity - first desire to void at 200 c.c. RV dilations" Augmented record: "Cysto-urethral stricture. Proximal urethra & trizone inflamed & granular. Urethra L46. Bladder capacity - first desire to void at 200 cc. Rx RV dilations" Date: May 18, 1993 Original record: "No urinary complaints now. Sounded #32 irrigated AgNO3. This concludes dilations" Augmented record: "No urinary complaints now. Sounded #32, irrigated AgNO3. This concludes diations. She has not gotten this years mammogram yet" Date: October 11, 1993 Original record: "Rem sent" [entry made by office staff]" Augmented record: "Reminder note sent - Exam due." [entry made by office staff]" Date: November 16, 1993 Original record: "On Premarin.625. Starting to awaken in the middle of the night again Nervous. No flashes. Bladder OK. New glasses. Trouble adjusting to fidders bifocals. GenPE, breasts & pelvic unchanged. Pap change to Premarin 1.25" Augmented record: "On Premarian.625. Starting to awaken in the middle of the night again. Very nervous. No flashes. Bladder OK. Finds it hard to adjust to her new bifocals. Gen PE unchanged. Breasts - mass still present. Again suggested she get a yearly mammogram or have mass excised. She has not arranged for a mammogram as she said she would. Pelvic unchanged. Rx Increased dose of Premarian to 1.25" The entries made in patient K. B.'s "augmented" record (Respondent's Exhibit 3) were not noted to be "late entries" nor were they dated. Both expert witness opined that this fell below the standard of care. Most of the "late entries" made by Respondent in the "augmented" record (Respondent's Exhibit 3) are a self-serving attempt by Respondent to create the impression that he had encouraged Patient K. B. to have follow-up mammograms or to have the breast mass excised. If the "augmented" record (Respondent's Exhibit 3) was a true reflection of the treatment rendered Patient K. B. by Respondent, his treatment could possibly have met the "standard of care." I find that the "augmented" record does not reflect the treatment Patient K. B. received, but that the original record (Petitioner's Exhibit 9) is the more credible document and accurately reflects Respondent's treatment of Patient K. B. Dr. Nelson, who testified as an expert witness, testified that Dr. Fromhagen fell below the standard of care in that (relying on both the original record and "augmented" record) between March 30, 1992, and April 13, 1993, he did not "deal with the breast mass, did not report discussion of treatment options with the patient, did not order a follow-up mammogram within 12 months." Again relying on both records, Dr. Nelson testified that Dr. Fromhagen fell below the standard of care for maintaining medical records when he failed to record his examination of Patient K. B.'s breasts and palpation of the mass which he reported as having been done "every visit she made." Both Dr. Von Thron, who also testified as an expert witness, and Dr. Nelson agreed that the standard of care requires that for any revision of medical records, if a change is made, a line is made through the original so it can be read and then the correction is made and the change is dated and initialed. If an additional statement is entered into the medical record, it should be dated and initialed. Dr. Fromhagen did not date or initial the changes or additions to Patient K. B.'s medical record when he created the "augmented" record. Both expert witnesses testified that this fell below the standard of care for medical record-keeping. Dr. Von Thron, referring to the original record, opined that Dr. Fromhagen did not comply with the standard of care for essentially the same reasons as expressed by Dr. Nelson. He opined that the "augmented" record indicates that Dr. Fromhagen complied with the standard of care.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is Recommended that the Board of Medicine enter a final order finding Respondent guilty of violating Subsections 458.331(1)(k), (m), and (t), Florida Statutes (1993), and imposing the following: A $1,000.00 fine for each violation, for a total of $3,000.00; and A one-year suspension followed by two years' probation; Ten hours of continuing medical education in ethics; An appropriate medical education course in medical record-keeping. DONE AND ENTERED this 5th day of March, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of March, 2001. COPIES FURNISHED: George Thomas Bowen, II, Esquire Law Offices of Donald Weidner, P.A. 11265 Alumni Way, Suite 201 Jacksonville, Florida 32246 John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue This is a license discipline case in which the Petitioner seeks to have disciplinary action taken against the Respondent on the basis of allegations that the Respondent has violated subparagraphs (m) and (t) of Section 458.331(1), Florida Statutes, by failing to keep written medical records justifying the course of treatment, and by failing to practice medicine with the appropriate level of care, skill, and treatment.
Findings Of Fact The Respondent, David Zufi, M.D., is and has been at all times material to this proceeding a licensed physician in the State of Florida, having been issued license number ME 0014856. The Respondent's last known address is 641 Reinaute Avenue, Coral Gables, Florida 33156-2345. The Respondent was and is a Board Certified plastic surgeon certified by the American Board of Plastic and Reconstructive Surgery since 1976. At all times material to this case, Dr. Ricardo Samitier-Cardet 1/ was the primary care physician or the attending physician for the Patient C.R. The Patient C.R. had sought out Dr. Samitier for the purpose of having several cosmetic surgical procedures performed; procedures which for a patient with a normal health history would have been minor cosmetic procedures. At all times material to this case, Dr. Samitier was a licensed practicing physician in the State of Florida. Dr. Samitier has never been Board Certified in any area of medicine. Dr. Samitier self-designated himself as a "cosmetic surgeon." At all times material to this case, the Respondent was unaware of any pending charges against Dr. Samitier. 2/ Prior to Friday, May 1, 1992, the Respondent was acquainted only marginally with Dr. Samitier. For a period of six months the Respondent had in the past rented office space one day a week to Dr. Samitier for consultation purposes. The Respondent had also spoken to Dr. Samitier a few times at meetings of the Coral Gables Hospital staff. The Respondent and Dr. Samitier had never shared any type of professional relationship with regard to the medical care of any patient. There were no referrals of patients between the two doctors, nor had the Respondent ever acted as a consultant in any capacity for Dr. Samitier prior to Friday, May 1, 1992. The Respondent had never visited Dr. Samitier's office prior to Friday, May 1, 1992. Dr. Samitier's medical records for the Patient C.R. include the following historical details. The patient had had an aortic valve replacement approximately twenty years earlier and had no history of angina. The patient was taking Coumadin, 5 mg. daily. The patient had no history of bleeding or hematomas and had normal erections. On Friday, May 1, 1992, at approximately 9:00 p.m., Patient C.R. underwent a Suction Assisted Lipectomy to the face, neck, and trunk, plus Circumferential Autologous Penile Engorgement (CAPE), which was performed by Dr. Samitier at Dr. Samitier's office. At the time of the foregoing surgical procedure Patient C.R. was a 47-year-old male who had previously undergone two open heart procedures, had a permanent pacemaker inserted, had a prosthetic aortic valve, and had been on Coumadin therapy for approximately twenty years. 3/ Coumadin is an anticoagulant drug which is taken to prolong a patient's blood clotting time. A patient maintained on long-term Coumadin therapy is at increased risk for clotting when the Coumadin is discontinued. The Patient C.R.'s long-term Coumadin anticoagulation therapy was made necessary by the fact that he had a prosthetic aortic valve. Before performing surgery on a patient with a history of cardiac problems such as those presented by the Patient C.R., a surgeon should obtain a cardiac clearance by means of consultation with a cardiologist. Dr. Samitier did not obtain a cardiology consultation prior to the surgery on the Patient C.R. 4/ A Prothrombin Time Test is a test which is utilized to evaluate a patient's blood clotting time. A Prothrombin Time Test should have been performed on the Patient C.R. immediately before the surgery on May 1, 1992. The test was not performed at that time. 5/ A Prothrombin Time Test was performed on the Patient C.R. about two weeks prior to the surgery. The Patient C.R. was a high risk patient who should never have been considered a candidate for elective surgery due to his history of cardiac problems, his prosthetic aortic valve, and his long-term Coumadin therapy. 6/ The two primary risks for a patient like Patient C.R. are that if his coagulation rate is substantially slower than normal the patient is at risk of uncontrollable bleeding at the surgery sites and if his coagulation rate becomes normal or slower than normal he is at risk of clot formation on his prosthetic aortic valve. Either condition can produce serious consequences, even fatality. On Friday, May 1, 1992, at approximately 11:30 p.m., which was approximately two hours after completion of the surgical procedure, the Patient C.R. began bleeding from his right cheek. It was a slow venous oozing bleed. The patient was taken back to the operating room where Dr. Samitier attempted without success to stop the bleeding with digital pressure. At approximately 2:30 a.m. on Saturday, May 2, 1992, by which time the bleeding from the patient's right cheek had persisted for approximately three hours, Dr. Samitier placed an emergency telephone call to the Respondent to request assistance in controlling the bleeding from a right buccal stab incision. The Respondent discussed the matter briefly with Dr. Samitier and told Dr. Samitier to try to control it with pressure. A few minutes later the Respondent became concerned that Dr. Samitier might need more assistance and called him back. During the second telephone call Dr. Samitier made it clear that he would feel more comfortable if the Respondent came to his office. The Respondent went to Dr. Samitier's office, arriving at approximately 3:00 a.m. on Saturday, May 2, 1992. Upon arrival, the Respondent discussed the situation with Dr. Samitier, obtained patient history information from Dr. Samitier, examined the patient, and promptly applied digital pressure with an adrenaline pad. The Respondent and Dr. Samitier alternated in the application of digital pressure and the bleeding stopped in approximately twenty minutes. There is no evidence that the patient was bleeding from any of the other surgical sites. While the Respondent was at Dr. Samitier's office, the Respondent did not review Dr. Samitier's medical chart on the Patient C.R. because he did not feel it was necessary to do so. During the entire time that the Respondent was examining, evaluating, and treating the Patient C.R., Dr. Samitier was right beside the Respondent providing the Respondent with information and answering the Respondent's questions about the patient. Under these circumstances, especially in view of the Respondent's limited role in the care of the patient, it was reasonable for the Respondent to rely on the oral information provided by Dr. Samitier and it was not necessary for the Respondent to review the written chart. 7/ Dr. Samitier advised the Respondent that the Patient C.R. had been on maintenance Coumadin and that the Coumadin had been discontinued three days prior to the surgery. Dr. Samitier also advised the Respondent that no pre- operative Prothrombin Time Test had been performed immediately prior to the surgery, and that the Patient C.R. had a pacemaker. At the time the Respondent was applying pressure to stop the oozing bleed, the Respondent was unable to communicate with the Patient C.R. because the patient was sedated with Nubain, a synthetic pain killer. Dr. Samitier explained to the Respondent that he had used Nubain during the surgical procedure and had also administered Nubain post-operatively when the patient had complained of pain during the course of Dr. Samitier's efforts to control the cheek bleeding prior to calling the Respondent. The Respondent's examination of the Patient C.R. included an examination of all of the surgical wounds inflicted during the procedures performed by Dr. Samitier, which included the cheeks, the portion of the neck immediately under the chin, and the lower abdominal area. No significant bruising or swelling was noted and no bleeding was detected at any of the incision sites other than the right buccal site which had occasioned Dr. Samitier's call to the Respondent. The Respondent looked for hematomas and ecchymosis and discoloration. There was no evidence that the patient had any generalized bleeding or hematoma at the time the Respondent was examining or treating him. During the entire time the Respondent was at Dr. Samitier's office in the early morning hours of Saturday, May 2, 1992, the Patient C.R. was connected to various monitors, all of which gave readings within normal ranges. The patient's blood pressure and pulse rate were both checked and found to be within normal ranges. While the Respondent was at Dr. Samitier's office during the early morning hours of Saturday, May 2, 1992, the Respondent discussed with Dr. Samitier the fact that the most prudent course of treatment for the Patient C.R. would be to hospitalize the patient. Dr. Samitier agreed that hospitalization would be the most prudent course, but then told the Respondent that he could not hospitalize the patient because the patient had told Dr. Samitier that he would not, under any circumstances, agree to be admitted to a hospital. Dr. Samitier also told the Respondent that the patient had said he did not want the nature of his operation to be disclosed to his wife or family members. During this discussion Dr. Samitier also disclosed to the Respondent that Dr. Samitier did not have admitting privileges at any hospital. In view of Dr. Samitier's reluctance to hospitalize the patient at that time, the Respondent told Dr. Samitier that Dr. Samitier should continue to monitor the patient and observe him clinically and if the vital signs or clinical observations demonstrated any deterioration of the patient's condition, or if the patient changed his mind about hospitalization, Dr. Samitier should call the Respondent and the Respondent would arrange to have the patient admitted into Coral Gables Hospital where the Respondent had admitting privileges. The Respondent also discussed with Dr. Samitier the need for a consultation with a cardiologist or hematologist in the event the patient were to be hospitalized. The Respondent emphasized the need for such a consultation before any action was taken to modify the patient's coagulation status. The Respondent's suggestions to Dr. Samitier regarding the future care and management of the Patient C.R. were appropriate under the circumstances. During the visit to Dr. Samitier's office during the early morning hours of Saturday, May 2, 1992, the Respondent did not recommend to Dr. Samitier that he have a Prothrombin Time Test performed on the Patient C.R. Although such a test might have been useful in the management of the patient's condition if the patient had been hospitalized, it is doubtful that the test would have served any useful purpose while the patient remained at Dr. Samitier's office. Under the circumstances, the failure to recommend a Prothrombin Time Test was not a departure from acceptable standards of medical practice. After the bleeding stopped, the Respondent remained at Dr. Samitier's office for at least two hours waiting to see if there was any recurrence of the bleeding. During that time period the Respondent examined the Patient C.R. several times to monitor his status and check for any bleeding. There was no recurrence of the bleeding from the patient's right cheek, nor was there any visible bleeding from any of the other surgical wounds. Sometime between 5:00 a.m. and 6:00 a.m. on Saturday, May 2, 1992, the Respondent left Dr. Samitier's office and returned to the Respondent's home. Dr. Samitier remained at his office to monitor and otherwise care for the Patient C.R. Dr. Samitier never contacted the Respondent to request that the Respondent arrange for the hospitalization of the Patient C.R. At approximately noon on Saturday, May 2, 1992, the Respondent was driving in his car a few blocks from Dr. Samitier's office. Because he was near Dr. Samitier's office, the Respondent decided to stop by Dr. Samitier's office to see how the patient was doing instead of making a telephone call later. The Respondent arrived at Dr. Samitier's office unannounced and inquired as to the status of Patient C.R. Dr. Samitier told the Respondent that the patient was doing fine, that his vital signs remained stable, that he was up and about, that he had taken oral sustenance, and that he had passed urine. Dr. Samitier also told the Respondent that the Respondent did not need to see the patient. After the foregoing discussion, Dr. Samitier invited the Respondent to observe a penile engorgement procedure Dr. Samitier was getting ready to perform on another patient. While walking with Dr. Samitier to the operating room, the Respondent had a brief glimpse of the Patient C.R. sitting up in bed in a small room. The Respondent continued on with Dr. Samitier and watched Dr. Samitier perform a penile engorgement procedure on another patient. After watching that procedure, the Respondent left Dr. Samitier's office. During the noon visit to Dr. Samitier's office on Saturday, May 2, 1992, the Respondent did not examine or treat the Patient C.R. On Sunday morning, May 3, 1992, at approximately 1:10 a.m., the Respondent received a telephone call from Dr. Samitier's office advising him that the Patient C.R. had gone into cardiac arrest. The Respondent went to Dr. Samitier's office. When the Respondent arrived at Dr. Samitier's office, the Patient C.R. was already being treated by emergency medical technicians. The emergency medical technicians told the Respondent that his services or assistance in the care of the patient were not needed and that they were going to transport the patient to Mercy Hospital. The emergency medical technicians took the Patient C.R. to Mercy Hospital where he was pronounced dead in the Emergency Room. The Respondent did not examine or treat the Patient C.R. during the early morning hours of Sunday, May 3, 1992. Later that same day an autopsy was performed on the body of the Patient C.R. The Respondent and Dr. Samitier attended the autopsy. The medical examiner did not come to any conclusion as to the cause of the patient's death. The Respondent did not document any of his contact with the patient C.R. in Dr. Samitier's office chart because the Respondent did not think it was necessary for him to do so. The Respondent thought it was sufficient for him to make his own record of what he did in the form of a consultation report. In the normal course of events he would have written such a report the following Monday when he got to his office, which seems to be a common practice of physicians who perform consultation services away from their own offices on weekends. There is no clear and convincing evidence that under the circumstances of this case the Respondent was required to write anything in Dr. Samitier's medical records concerning the Patient C.R. There is no established practice in this regard because it is very rare for a physician to perform consultation services in the office of another physician. Further, although consultation reports are virtually always prepared following formal consultations, when a consulting physician is called in for a very limited purpose, performs his services in the presence of the primary care physician or the attending physician, and orally advises the primary care physician or the attending physician what he has discovered or done, the consulting physician often does not prepare any written report at all, but leaves it to the primary care physician or the attending physician to memorialize what was discovered or done in the patient's chart. During the late afternoon or early evening of May 3, 1994, after the autopsy of the Patient C.R., the Respondent wrote a historical recapitulation of his involvement with the care and treatment of the Patient C.R. The record prepared by the Respondent on May 3, 1992, documents the Respondent's involvement in the care and treatment of the Patient C.R. The record demonstrates the Respondent's observations, recommendations, treatment, and the reasons why the Respondent did not get involved in all aspects of the patient's care. The record prepared by the Respondent on Sunday, May 3, 1992, was sufficiently timely to comply with applicable standards of medical care and record-keeping. The information contained in that record was sufficient to comply with applicable standards of medical care and record-keeping. The Respondent was called by Dr. Samitier for the limited function of stopping an oozing venous bleeding from an incision wound in the right cheek of the Patient C.R. The Respondent's consultation in this regard was of an informal nature and was limited in scope. His treatment of stopping the bleeding with direct pressure with an adrenalin pad was an appropriate course of treatment for the condition he was called to resolve. The Respondent was not at any time the primary care physician or attending physician for the Patient C.R.; that responsibility was at all material times the responsibility of Dr. Samitier. By assisting Dr. Samitier to stop the bleeding from one incision wound, the Respondent did not undertake, nor did he become responsible for, the overall care and management of the patient. Inasmuch as the nature of the consultation the Respondent was asked to perform was limited in scope, the Respondent's examination of the Patient C.R. was sufficient. Under the circumstances of this case it was not necessary for the Respondent to perform a comprehensive physical examination. The Respondent's authorized role in the care of the Patient C.R. was complete when he departed between 5:00 and 6:00 a.m. on the morning of Saturday, May 2, 1992. He had performed all he had been authorized to perform and, although he had offered to do more (such as arrange for the patient to be hospitalized), his offer of further assistance was rejected by Dr. Samitier. When the Respondent paid his courtesy visit to Dr. Samitier's office at about noon on Saturday, May 2, 1992, the Respondent did not have permission or authority from anyone to examine or treat the Patient C.R. At that time Dr. Samitier expressly told the Respondent that the Respondent did not need to see the patient. Under those circumstances, the Respondent had neither authority nor obligation to examine the Patient C.R. at the time of his noon visit on Saturday, May 2, 1992.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine enter a Final Order in this case dismissing all charges against the Respondent. DONE AND ENTERED this 9th day of January, 1995, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of January, 1995.
The Issue The issues in this case are whether Respondent, a physician specializing in obstetrics and gynecology, committed medical malpractice in delivering a baby and/or failed to maintain medical records justifying the course of the mother's treatment; if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action.
Findings Of Fact At all times relevant to this case, Respondent Mark N. Scheinberg, M.D., was licensed to practice medicine in the state of Florida. He is board-certified in obstetrics and gynecology. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Scheinberg. 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. Scheinberg committed two such offenses——namely, medical malpractice and failure to keep records justifying the course of treatment——in connection with the vacuum-assisted vaginal delivery of an infant born to Patient L.G. on February 2, 2005, at West Boca Medical Center. The crux of this case (though not the sole issue) is whether, as the Department contends, the standard of care required Dr. Scheinberg to perform a Caesarean section ("C- section") on L.G. due to the passage of time, instead of allowing her to continue to labor for approximately 13 hours and, ultimately, deliver vaginally. The events giving rise to this dispute began on February 1, 2005, at around 11:00 a.m., when L.G., whose pregnancy was at term, checked into the hospital after having experienced ruptured membranes. At 12:30 p.m. that day, L.G. signed a form bearing the title "Authorization for Medical and/or Surgical Treatment," which manifested her consent to a vaginal delivery or C-section together with, among other things, "such additional operations or procedures as [her physicians might] deem necessary." Immediately above L.G.'s signature on the form is an affirmation: "The above procedures, with their attendant risks, benefits and possible complications and alternatives, have been explained to me " The evidence is not clear as to when, exactly, Dr. Scheinberg first saw L.G., but that fact is unimportant. The medical records reflect that at 8:30 p.m. on February 1, 2005, Dr. Scheinberg gave a telephone order to initiate an IV push of the antibiotic Ampicillin; therefore, he had taken charge of L.G.'s care by that time. The nurses' notes indicate that at 10:00 p.m., L.G.'s cervix had dilated to "rim" or approximately nine centimeters—— meaning that the dilation was complete, or nearly so. At this time, and throughout the duration of L.G.'s labor, an external fetal heart monitor was in place to detect and record the baby's heartbeats and the mother's uterine contractions. An intrauterine pressure catheter ("IUPC")——a device that precisely measures the force of uterine contractions——was not inserted into L.G.'s uterus at any time during this event. The Department argues (although it did not allege in the Complaint) that, at some point during L.G.'s labor, the standard of care required Dr. Scheinberg either to place an IUPC or perform a C-section. Pet. Prop. Rec. Order at 10, ¶36. The Department's expert witness, Dr. John Busowski, testified unequivocally and unconditionally, however, that the standard of care does not require the use of an IUPC. T. 36. The undersigned credits this evidence and finds that Dr. Scheinberg's nonuse of an IUPC did not breach the standard of care. Dr. Scheinberg conducted a physical at around 2:00 a.m. on February 2, 2005, which included taking L.G.'s complete history and performing a vaginal examination. L.G.'s cervix remained dilated to approximately nine centimeters, and her labor had not substantially progressed for about four hours. Dr. Scheinberg noted in L.G.'s chart that the baby was in the posterior position at 2:00 a.m. The Department argues, based on Dr. Busowski's testimony, that as of 2:00 a.m., the standard of care required [Dr. Scheinberg to] choose one of the following options: (1) watch the patient for a few more hours to allow for progress; (2) place an IUPC to determine the adequacy of Patient L.G.'s contractions; (3) start Pitocin without the placement of an IUPC; or (4) perform a C- section. Pet. Prop. Rec. Order at 9-10, ¶ 32. The Department contends that Dr. Scheinberg breached the standard of care by choosing "simply to watch the patient for approximately 10 more hours"—— which was tantamount to "choosing to do nothing." Id. at 10, ¶¶ 33-34. In fact, Dr. Scheinberg chose to watch the patient, which was, according to Dr. Busowski, within the standard of care. Obviously, at 2:00 in the morning on February 2, 2005, Dr. Scheinberg did not choose to wait for 10 more hours, because at that point he (unlike the parties to this litigation) did not know what was about to happen. The nurses' notes reflect that L.G. was under close observation throughout the early morning hours, and that Dr. Scheinberg was following the situation. At 4:30 a.m., L.G. was set up to push and at 4:45 a.m. was pushing well. At 6:15 a.m., the notes indicate that Dr. Scheinberg was aware of the mother's attempts to push. At 6:45 a.m., he reviewed the strips from the fetal heart monitor. At 7:45 a.m., he was present and aware of L.G.'s status. From 7:00 a.m. until 8:00 a.m., no contractions were identifiable on the external monitor. At 8:00 a.m., however, L.G. was comfortable and pushing well. She stopped pushing at 8:30 a.m., but remained comfortable. Dr. Scheinberg then ordered the administration of Pitocin, a medicine which is used to strengthen contractions and hasten delivery. Although the Department faults Dr. Scheinberg for giving L.G. Pitocin at this relatively late stage of her labor, Dr. Busowski (the Department's expert witness) admitted being unable to say "that Dr. Scheinberg should have started Pitocin earlier " T. 72. The Department therefore has no clear evidential basis for second-guessing Dr. Scheinberg's professional judgment in this particular, and neither does the undersigned. At 9:10 a.m., L.G. resumed pushing. The baby's fetal heart tones (heartbeats) were stable. L.G. continued pushing, with her family present, until around 11:00 a.m., at which time Dr. Scheinberg discussed the situation with the patient and her family. Dr. Scheinberg explained to L.G. or her husband the risks of, and alternatives to, performing a vacuum-assisted vaginal delivery. Either L.G. or her husband gave verbal consent to the use of a vacuum device to assist in the delivery. Between 11:00 a.m. and 11:10 a.m., the fetal heart monitor detected some variable decelerations, meaning a decrease in heart rate that could be a sign of fetal distress. Dr. Scheinberg delivered the baby at 11:23 a.m., using a vacuum device to help pull the infant out of the birth canal. In his post-operative notes, Dr. Scheinberg wrote that his "pre-operative diagnosis" was "+3 station — prolonged second stage 2½ hrs." As a "post-operative diagnosis," Dr. Scheinberg recorded, "same + tight cord." He reported the following "findings": "tight cord cut on perineum[;] mec[onium] aspirated on perineum."
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 Dr. Scheinberg not guilty of the charges set forth in the Complaint. DONE AND ENTERED this 20th day of June, 2011, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM 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 20th day of June, 2011.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against a licensed medical doctor. By means of a two-count Administrative Complaint, the Respondent is charged with violations of Sections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, by allegedly failing to keep written medical records justifying the course of treatment of a patient, and by failing to practice medicine with the required level of care, skill, and treatment. The Respondent denies the violations charged in the Administrative Complaint, and also asserts that the Administrative Complaint should be dismissed by reason of the Petitioner's failure to timely investigate and prosecute the subject charges.
Findings Of Fact Findings stipulated by the parties4 The Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida. The patient R. C. presented with a history of diabetes and hypertension. The Respondent did not attempt or make any contact with the primary care physician of patient R. C. Brevital was administered intravenously to the patient R. C. without the use of an IV pump. Resuscitative drugs and equipment should always be immediately available. There is no documentation of respiratory monitoring during the administration of anesthetics and the surgical procedure performed on patient R. C. It is well below the standard of care to both administer a general anesthesia and perform the surgical procedure. Findings based on evidence At all times material, the Respondent has specialized in urology. The Respondent is not board certified in urology. At all times material to this case, the Respondent was associated with a clinic named Instituto Latino Americano de Impotencia y Diagnostico (ILAID). One or two days each week, the Respondent would see patients at ILAID that were potential candidates for penile implant surgery. At all times material to this case there were at least two other licensed physicians associated with ILAID who often were the first physicians to see patients who came to ILAID with complaints of impotency. The subject patient (Patient R. C.) went to ILAID for the first time on May 24, 1993. On that day the patient signed a form titled "Patient Information," which contains little more than patient identification information, and a form titled "Patient's Declaration and Agreement."5 The patient probably saw a physician at ILAID on May 24, 1993, because a blood sample was taken from the patient that day and the results of the blood tests were reported back to ILAID on May 25, 1993. However, there is no documentation that the patient was seen by a physician at ILAID on May 24, 1993. Specifically, there is no medical chart documenting that on that day a physician took a history from the patient, examined the patient, evaluated the patient, ordered any tests of the patient, or otherwise treated or cared for the patient. At all times material to this case, the routine practice and procedure of ILAID regarding patients who went to ILAID with complaints of impotency was to have the patients seen by a physician associated with ILAID. It was also the routine practice and procedure at ILAID for the physician who first saw the patient to prepare a-medical record documenting the patient's visit. Such a medical record would routinely document a patient history, an examination of the patient, the physician's evaluation of the patient, and any treatments given or tests ordered by the physician. The impotency patients at ILAID were also routinely put through an evaluation procedure to determine the extent of and the nature of their impotency before implant surgery was recommended or performed. The results of the evaluation procedure were also routinely documented in the patient's medical chart. The Respondent first saw the subject patient on July 13, 1993, at the ILAID facility. On that date there were no patient records regarding the subject patient prepared by any other physician associated with ILAID for the Respondent to review. In the absence of any medical documentation, the Respondent apparently assumed that the patient had been through the normal routine at ILAID and proceeded to go forward on that assumption. On July 13, 1993, the Respondent took a brief, limited history from the patient and conducted a limited physical examination of the patient. The physical examination was limited to the patient's abdomen and urogenital area. Based on that limited history and examination, the Respondent concluded that penile implant surgery was an appropriate course of treatment, subject to the patient receiving medical clearance for the surgery. The Respondent did not perform any objective tests for impotence on the patient. The Respondent did not obtain a detailed medical history from the patient. The Respondent did not obtain a detailed history regarding the nature, extent, or duration of the patient's impotence. The Respondent did not conduct a complete physical examination of the patient. Prior to performing penile implant surgery, a physician should perform objective tests to determine if the surgery is indicated. Two objective tests that should always be performed are blood tests to determine the patient's testosterone level and prolactin level.6 Depending on the details elicited during the patient history, other objective tests may also be indicated. The Respondent failed to have tests done to determine the testosterone level and the prolactin level of the patient. The failure to perform these two objective tests is a departure from acceptable standards of medical care recognized by a reasonably prudent similar physician. Prior to performing penile implant surgery, a patient's condition must be assessed by a physician to determine whether surgery is indicated. The surgeon does not have to personally perform all aspects of the assessment of the patient's condition, but the surgeon must at least verify that an adequate assessment has been performed by another physician, and that the assessment has been documented in the patient's medical records. Adequate assessment of a patient's condition requires, at a minimum, a detailed medical history, a complete physical examination, and the performance of any objective tests indicated by the history and physical examination. The performance of surgery without either performing an adequate assessment of the patient's condition or verifying that such an assessment has been documented by another physician is a departure from acceptable standards of care recognized by a reasonably prudent similar physician. The Respondent did not obtain a detailed medical history from the patient, did not perform a complete physical examination of the patient, and failed to order at least two objective tests that were indicated by the patient's complaints. The Respondent also failed to verify that documentation existed which showed that any other physician had obtained a detailed medical history from the patient, had performed a complete physical examination of the patient, and had ordered the objective tests indicated by the patient's complaints. If the Respondent had attempted to verify the existence of such documentation, he would have discovered that the documentation did not exist. The Respondent's performance of surgery on the patient without performing an adequate assessment of the patient's condition, or without verifying that such an assessment had been documented by another physician, was a departure from acceptable standards of medical practice. The Respondent made arrangements for additional blood tests and for an EKG to be administered to the patient. The Respondent also believed that he had made arrangements for one of the other physicians at ILAID to medically clear the patient for surgery. Anticipating no problems regarding the medical clearance, the Respondent also contacted the director of ILAID, Rogelio Medel, and asked him to arrange a location for the implant surgery. In view of the patient's financial circumstances and his lack of medical insurance, it was decided that the surgery would be done in an operating room at a physician's clinic, which would be somewhat less expensive than performing the surgery in a hospital operating room. Rogelio Medel contacted Dr. Francisco A. Prado and arranged for the use of one of the operating rooms at Dr. Prado's clinic. Rogelio Medel had made similar arrangements with Dr. Prado twice before. The arrangement with Dr. Prado was that Dr. Prado would provide not only the use of the operating room, but would also provide all necessary supplies (including the anesthesia medications), as well as the services of a nurse anesthetist, Eduardo Perez, who worked for Dr. Prado on a regular basis. The surgery was scheduled for early in the afternoon on July 16, 1993. Unbeknownst to Rogelio Medel and to the Respondent, Eduardo Perez was not a licensed nurse anesthetist. The Respondent did not inquire of Eduardo Perez regarding the latter's qualifications or licensure status. Rather, relying on the representations of Dr. Prado, the Respondent assumed that Eduardo Perez possessed the necessary qualifications and licensure to function as a nurse anesthetist. While it is clear that Eduardo Perez was not licensed as a nurse anesthetist, there is no clear and convincing evidence in the record as to whether Eduardo Perez was or was not trained in the use of anesthetics, was or was not trained in the use of respiratory and cardiac monitoring equipment, or was or was not trained in the use of resuscitative drugs and equipment.7 The Respondent assumed that Eduardo Perez was trained in these matters, based on the assumption that Eduardo was a licensed nurse anesthetist. In view of the representations of Dr. Prado, it was reasonable for the Respondent to make that assumption.8 The Respondent was not trained in the techniques and procedures of advanced cardiac life support. The Respondent was not trained in the use of a defibrillator. The Respondent was not trained in the use of anesthetics. Prior to performing surgery on the subject patient, the Respondent had received a copy of the laboratory results dated July 16, 1993. He had also received a copy of the EKG report prepared by Dr. Freddie Rodriguez. Prior to performing the surgery, the Respondent had not received any written medical clearance for the patient to undergo the planned implant surgery. The Respondent never received any written medical clearance for the patient to undergo surgery, because the patient was never medically cleared. The Respondent did not receive any telephonic verification that the subject patient had been medically cleared for surgery, because no other physician had cleared the patient for surgery.9 Prior to performing surgery, it is the responsibility of the surgeon to verify that the patient has been medically cleared for the proposed surgery. Under similar conditions and circumstances, a reasonably prudent similar physician would not perform surgery without verification that the patient had been medically cleared for the proposed surgery. It is a departure from minimum standards of medical practice for a surgeon to perform surgery without such verification. Early in the afternoon on July 16, 1993, the Respondent performed penile implant surgery on the subject patient. The surgery was conducted in one of the operating rooms at Dr. Prado's clinic, as previously arranged with Dr. Prado. During the surgery the patient was anesthetized with the anesthetic agents Versed and Brevital. These anesthetic agents were administered by Eduardo Perez, who was functioning as a nurse anesthetist. Eduardo Perez was present during the entire surgical procedure, during which time he monitored the administration of the anesthetic agents, monitored the patient's vital signs, and otherwise performed the functions that would be performed by a nurse anesthetist. At all times material, the Respondent believed, based on the representations of Dr. Prado, that Eduardo Perez was a licensed and qualified nurse anesthetist who regularly worked in that capacity for Dr. Prado. When the surgical procedure had been completed, the Respondent left the patient in the care of Eduardo Perez while the Respondent left the operating room to change clothes. When the Respondent left the operating room the patient appeared to be normal. When the Respondent returned to the operating room a few minutes later, he noticed that the patient had become pale and sweaty. The Respondent also noticed that the patient had very little pulse or blood pressure. The Respondent and Eduardo Perez initiated cardiopulmonary resuscitation and also called fire rescue for assistance. The Respondent and Eduardo Perez continued their cardiopulmonary resuscitation efforts until the fire rescue personnel arrived a few minutes later. The fire rescue personnel initiated advanced cardiac life support measures and subsequently transported the patient to a hospital emergency room, where further efforts were made to resuscitate the patient. Shortly thereafter the patient was pronounced dead in the emergency room. Following an autopsy and investigation into the cause of death, the Dade County Medical Examiner was of the opinion that it could not be stated with any degree of medical certainty that the death of the subject patient was caused by the surgery. In order to have medical records sufficient to justify penile implant surgery, a physician must have written medical records that document at least the following matters: (a) a detailed patient history; (b) a complete physical examination of the patient; (c) a consideration of alternative therapy options; and (d) a pre-operative medical clearance. With regard to the subject patient, the Respondent does not have, and never did have, written medical records documenting any of the four matters itemized immediately above. By failing to keep written medical records documenting such matters with regard to the subject patient, the Respondent failed to keep records justifying the course of treatment of the patient.10
Recommendation On the basis of all of the foregoing it is RECOMMENDED that a Final Order be issued in this case concluding that the Respondent has violated Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, imposing a penalty consisting of the imposition of administrative fines totaling $6,000. 00, and the suspension of the Respondent's license to practice medicine for a period of 90 days. DONE AND ENTERED this 23rd Day of September, 1998, in Tallahassee, Leon County, Florid __________________________________ MICHAEL M. PARRISH 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 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 1998.
The Issue Is Respondent subject to discipline for his actions in relation to Patient J.N.?
Findings Of Fact Stipulated Facts and Admitted Facts: Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapter 456, Florida Statutes and Chapter 458, Florida Statutes. Respondent is and has been at all times material hereto, a licensed physician in the State of Florida, having been issued License No. ME0063587. Respondent rendered medical care and treatment to Patient J.N. Additional Facts: As of October 15, 1999, Patient J.N. had been Respondent's long-standing patient. On that date she came to Respondent's office in Perry, Florida, without an appointment. Her principal purpose for the visit was to ascertain whether she was pregnant. Although J.N. had no appointment, she was seen by Wendy Brannen, C.N.A., who worked in Respondent's office. Ms. Brannen administered a pregnancy test. The results were negative. On the subject of the pregnancy test, J.N. had commented to Ms. Brannen that if the results were negative from the pregnancy test, that J.N. was interested in obtaining diet pills to address weight gain not attributable to pregnancy. Her weight on this visit, as confirmed by a weigh-in, was not extraordinary. When Ms. Brannen had concluded her preliminary patient work-up concerning J.N.'s blood pressure, pulse, respiration and temperature, J.N. was taken to Examining Room 5 within the office and left there. The door was open to the examining room and remained open during the time J.N. was there. On October 15, 1999, Respondent saw J.N. in Examining Room 5. While in the room he explained that the results of the pregnancy test that had been administered on that day were negative. He told J.N. that she was not gaining weight. J.N. asked Respondent about diet pills. Respondent told J.N. that she did not need diet pills, that she was not over weight. He also mentioned an existing moratorium from the Board of Medicine on the prescription of diet pills. Contrary to the allegations in the Administrative Complaint, the evidence was insufficient to prove that Respondent "pulled J.N. by the arm and started kissing her and then took her left hand and pressed it against his penis" or that Respondent in any other manner engaged in conduct with sexual overtones directed to Patient J.N. on the date in question. This determination is made having in mind the full hearing record, to include the "Williams Rule" evidence from Patient J.F., who had been under Respondent's care in the past.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered which dismisses the Administrative Complaint. DONE AND ENTERED this 6th day of February, 2002, in Tallahassee, Leon County, Florida. 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 6th day of February, 2002.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as certain stipulations of fact, the following relevant facts are found: The respondent Ali Azima was born in Iran and graduated from the Medical College at Tehran University, where he received his M.D. degree in 1961. He is Board-certified as an obstetrician-gynecologist. His experience includes the delivery of approximately 5,000 to 6,000 babies, the performance of approximately 3,500 termination of pregnancy procedures and the provision of about 1,000 intrauterine contraceptive devices to patients. At all times relevant to the charges in these proceedings, respondent was licensed by the Board of Medical Examiners in the State of Florida. Prior to the instant charges, respondent has had no Administrative Complaints filed against him. On February 18, 1981, Christine Sellers (now Kuchar) was admitted to the emergency room of Ft. Myers Community Hospital with severe abdominal pain. On that occasion, she learned that she was pregnant. On February 19, 1981, she went to the Southwest Florida Women's Clinic in Ft. Myers, operated by the respondent, for the purpose of terminating her pregnancy. Upon her arrival at the Clinic, she was asked to pay the requested fee and to complete two forms, a form entitled "Consent for Abortion, Anesthesia and Other Medical Services" and a form entitled "Patient Registration Record." The only medical information requested on these forms, in addition to height, weight and eye and hair color, regarded allergies to foods or medication, medication currently being taken and past operations or serious illnesses. For the latter question, N. Sellers answered "rheumatic fever." Respondent spoke to her for a few moments prior to the procedure, and performed a quick pelvic examination. He then performed the procedure for termination of the pregnancy, gave her some medication and instructed her to come back the following week for a follow-up examination. Respondent did not send any tissue specimen obtained from the procedure to a pathologist for examination nor did he administer Rhogam to the patient subsequent to the procedure. According to Ms. Sellers, neither respondent nor his staff performed any blood work or determined her vital signs before or after the abortion procedure, nor did anyone inquire of her as to her blood type or Rh factor. She knew that her Rh factor was negative, but did not volunteer this information to respondent because she did not realize that a negative Rh factor was important for purposes of a termination of pregnancy procedure. Respondent's medical records for Ms. Sellers do not indicate that blood was drawn from her or that her Rh factor was determined or known. While the record does indicate that a physical examination was "normal," no further information is provided. Ms. Sellers did not desire to return to respondent for her follow-up appointment. Instead, she made an appointment with Dr. Randall Cowdin for the same day she was supposed to see the respondent, February 26, 1981. On that occasion, Ms. Sellers was given a complete physical examination and her blood type was drawn. Upon learning that she had not been administered Rhogam following her termination procedure by respondent, Dr. Cowdin gave her an injection of Mini-Rhogam on February 26, 1981. Approximately one week later, on March 5, 1981, Ms. Sellers returned to Dr. Cowdin's office with complaints of severe right lower quadrant abdominal pain, with some nausea and vomiting. Dr. Cowdin determined that she was bleeding internally due to a ruptured right ectopic pregnancy, and immediately admitted her to the hospital. Emergency surgery was performed, resulting in the removal of the patient's right Fallopian tube and ovary. Ectopic or tubal pregnancies are difficult to diagnose. However, had a specimen of the tissue extracted from Ms. Sellers as a result of the procedure performed by respondent been carefully examined, it would have revealed that the products of conception had not been obtained from the patient's uterus as a result of that procedure. This finding would have at least raised the suspicion of an ectopic pregnancy. It would be extremely rare for a woman to have both an ectopic and a normal pregnancy at the same time. The chances for such an event are one out of 30,000. When performing abortions, four other physicians in the Ft. Myers area routinely send a tissue specimen to a pathology laboratory for examination. The purposes for this are to detect abnormalities, to determine if the patient was indeed pregnant and to determine the existence of an ectopic pregnancy. It is the respondent's practice to examine the tissue himself, having had some residency training in pathology and feeling competent to perform such an examination. If he has any doubts, he then sends a tissue specimen to a pathologist for further examination. It is extremely important to do a blood screening on a patient undergoing a termination of pregnancy proceeding. A determination of the hemoglobin level is significant in order to assess the risk of a procedure performed in a non-hospital setting and to prepare for the possibility of anemia after the procedure. The Rh factor needs to be determined so that Rhogam may be administered to the Rh negative patient. This injection combats antibodies and prevents sensitization or isoimmunization problems in the event of future pregnancies or future transfusions where the patient could again come into contact with Rh positive blood cells. The performance of a procedure to terminate a pregnancy without a determination of the patient's hemoglobin level and Rh factor constitutes medical treatment which falls below an acceptable standard of care. The patient medical records for Holli Schmidt indicate that she first went to the Southwest Florida Women' a Clinic, Inc. on December 1, 1977, and Dr. Azima performed a termination of pregnancy procedure. Her "Patient Information Sheet" lists her blood type and Rh to be "A+." On her follow-up exam, an IUD was inserted. This device was removed in December of 1980. On February 23, 1981, Holli Schmidt again went to respondent's Clinic. She completed a "Consent for Abortion, Anesthesia and Other Medical Services" form, told respondent that her last menstrual period had been about six weeks ago and that she was experiencing breast tenderness and nausea. A pregnancy test was performed on her, and the results were negative. Respondent performed a physical exam, noting on her record "Normal," and a pelvic exam, noting "Normal, uterus is not enlarged." Respondent then inserted a Copper 7 IUD, and instructed Mrs. Schmidt to return in one week. Ms. Schmidt did return on March 5, 1981, still complaining of breast soreness and slight nausea. Respondent performed another physical exam, noting "Normal," and a pelvic examination, noting "String is not visible, uterus sounded and IUD is in situ." The medical records do not indicate that she was given another pregnancy test on March 5, but respondent testified that she was and that such was written in the "pregnancy test book," a document not offered for admission into evidence. The records dated February 23 and March 5, 1981, do not indicate that blood work was done or that vital signs were taken. Mrs. Schmidt was instructed to return on March 14, 1981, but did not do so. On April 27, 1981, Holli Schmidt went to the offices of Yankopolos, Waterman and Cowdin, each of whom specializes in obstetrics and gynecology. The record dictated by Dr. Yankopolus indicates that Mrs. Schmidt told him that respondent had examined her the week before. She also told Dr. Yankopolus that she was having trouble with her IUD and was not feeling quite right, having symptoms of pregnancy. Dr. Yankopolus examined her, did not see the IUD string and determined that she was approximately 12 weeks pregnant. Fetal heart tones, which can be detected at 9 1/2 to 10 weeks of pregnancy, were heard. Dr. Yankopolus did no tests to determine if the IUD was still present, but did explain to Ms. Schmidt the dangers of possible miscarriage and infection from the presence of the IUD during pregnancy. It was noted that Ms. Schmidt "will consider all of the alternatives." On May 1, 1981, Ms. Schmidt presented herself to Dr. Waterman "for termination of pregnancy with a Copper 7 in place." After an examination, Dr. Waterman estimated that she was then "12-14 weeks size," and Dr. Cowdin concurred. This meant that conception occurred 10-12 weeks prior to the May 1st examination. Dr. Waterman performed the termination of pregnancy procedure. While his medical records for May 1, 1981, do not specifically state that he removed the IUD during the termination procedure, Dr. Waterman recalls that he did. A later notation on her medical records indicates that on March 30, 1982, Ms. Schmidt stated "she specifically remembers my removing it." Prior to the insertion of an intrauterine contraceptive device, the most important factor to determine is that the patient is not pregnant. An IUD can be the source of infection, thus endangering the mother and the baby during pregnancy. The safest and most appropriate time to insert an IUD is during the woman's normal menstrual period. While there are exceptions to this method, especially when the physician knows and trusts the patient, it falls below an acceptable level of care for a physician to insert an IUD when the patient has not had a menstrual period for six weeks, has symptoms of pregnancy and has been engaging in unprotected intercourse. Colleen Lundy, a registered nurse, went to respondent's office on March 5, 1981, for the purpose of undergoing a termination of pregnancy procedure. She completed the consent form and "Patient Registration Record" and spoke briefly with the respondent regarding some questions she had as to the procedure. Prior to the beginning of the procedure, no vital signs were taken and no blood work was performed. Respondent's medical record for Ms. Lundy simply indicates that the physical examination was "Normal." After respondent inserted the speculum, he requested his assistant to bring him Betadine, an antiseptic. The assistant informed him they were out of Betadine, and respondent replied, "use alcohol." Thereafter, patient Lundy felt a severe burning and was feeling very uncomfortable with the whole procedure. She informed respondent that she was not going to have the procedure, respondent removed the speculum and left the room, she dressed, received a refund of her fee and left. The burning sensation abated quickly. The following day, patient Lundy received a termination of pregnancy procedure at another clinic. Respondent admits that he told his assistant that alcohol could be used, but denies using any alcohol on patient Lundy. He further states that he did not perform the blood work because he did not perform the abortion. Darlene Baker first underwent a termination of pregnancy procedure performed by respondent in January of 1981. At that time, she completed a "Patient Registration Form," which inquired as to her height, weight, eye and hair color, allergies, prior operations or illnesses and current medications. She returned for another procedure on December 23, 1982, which was performed by the respondent. She received no counseling prior to the performance of this procedure, but did sign a consent form and a form explaining the procedure and risks for abortion. No further written information was obtained from her. While patient Baker does not recall that a physical examination or blood work was performed prior to the performance of the termination procedure, respondent's medical records for this patient indicate that a physical and pelvic examination were performed, that a blood pressure reading was taken and that the patient's "Rh is positive." Respondent did not send a tissue sample of the products of conception to a pathologist for further examination. Other physicians specializing in obstetrics and gynecology in the Ft. Myers area make it a routine practice to counsel abortion patients prior to the performance of the procedure. During the counseling session, the risks of the procedure involved are examined and other options for the management of an unwanted pregnancy are explored. Sufficient time is afforded between the counseling session and the performance of the termination procedure for patient reflection. The physical examination performed by these physicians includes the taking of vital signs, blood pressure, blood tests and a check of the abdomen, heart and lungs. Subsequent to the procedure, the products of conception are sent to a pathology laboratory for examination and the results are made a part of the patient's medical records.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent be found guilty of violations of Section 453.331(1)(t), Florida Statutes, and that his license to practice medicine in Florida be suspended for a period of one (1) year. Respectfully submitted and entered this 24th day of July, 1984, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of July, 1984. COPIES FURNISHED: J. Riley Davis, Esquire 225 S. Adams St. Tallahassee, Florida 32301 Stephen Marc Slepin, Esquire 1114 E. Park Ave. Tallahassee, Florida 32301 Ellis S.Rubin, Esquire 265 NE 26 Terrace Miami, Florida 33137 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 N. Monroe St. Tallahassee, Florida 32301 =================================================================
The Issue The issues to be resolved in this proceeding concern whether the Respondent has failed to practice medicine at the level of care, skill, and treatment recognized by reasonably prudent, similarly-situated physicians, by allegedly failing to appreciate the nature of a complaint, failing to order a proper diagnostic test, and failing to make a timely referral to an appropriate specialist, as well as whether the Respondent failed to keep adequate medical records documenting a rationale for his diagnosis of the patient, in alleged violation, respectively, of Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes.
Findings Of Fact The Petitioner is an agency of the State of Florida charged with regulating the practice of medicine and enforcing the licensure and practice standards contained in Chapter 458, Florida Statutes, and appurtenant rules. The Respondent, at all times material to this proceeding, has been a licensed physician in the State of Florida holding license number ME 0032003. On or about October 3, 1986, Patient #1, a thirty-five year-old male, presented to the Respondent's office with complaints of testicular pain, swelling, and a lump in the vicinity of the left testicle. The patient was seen by Dr. Laski, a physician (M.D.) employed by the Respondent. Dr. Laski examined the patient and diagnosed him as suffering from epididymitis. Epididymitis is an inflammation of the epididymis, which is a series of tubules that runs from the testicle to the vas deferens. The epididymis partially surrounds the testicle but is not actually a part of the testicle itself. The epididymis is part of the scrotal structures, and is attached to and continuous with the testicle, both being located within the scrotum. Patient #1 related that while working at his job as a truck driver, he was straining, trying to lift or move a 427-pound hot tub, when he felt pain and swelling in the left testicle, associated with a small lump. Upon diagnosing epididymitis, Dr. Laski started a treatment regimen of antibiotic and anti- inflammatory medications. He required the patient to return in four to five days. Dr. Laski saw the patient the second time on October 8, 1986 with continued complaints of left testicular pain. Dr. Laski again continued the same diagnosis and treatment. On October 13, 1986, Patient #1 again presented to Dr. Laski with continued left testicular pain with a small mass on the left testicle. Dr. Laski continued his diagnosis of epididymitis and continued the antibiotic and anti-inflammatory medications, although he changed the type of antibiotic prescribed. The patient visited a fourth time on October 17, 1986, and Dr. Laski found a tender nodule over the left testicle but also found that the remainder of the symptoms, consisting of pain and swelling, had disappeared. Dr. Laski found on the patient's first and fourth visits to him, and noted in the medical records, a mass or nodule on the left testicle; however, on the fourth visit, he found that the acute symptoms had disappeared. Dr. Laski still felt the nodule, which he could not ascribe to anything related to the purported accident experienced by the patient. Therefore, Dr. Laski felt that a urologist would be the appropriate person to see, "to take no chances and to make sure that there was not something else." Dr. Laski, accordingly, noted in his records that a referral to a urologist was in order. This was on Friday afternoon, October 17, 1986. The Respondent's office staff apparently made an attempt to refer the patient to a urologist that afternoon but was unsuccessful, due to the inability to contact the urologist's office. Apparently, the patient was instructed to call the Respondent's office the following Monday or Tuesday concerning the referral appointment. The patient maintains that he called the Respondent's office on Tuesday and was told that they could not send him to a specialist until the Respondent himself saw the patient. The Respondent disputes this and states that there is no such policy in his office that he had to see any patient before referral out to a specialist could occur. In any event, on October 22, 1986, Dr. Laski saw the patient again and called in the Respondent, who also examined the patient. The evidence of record does not indicate clearly why the Respondent took over the care and treatment of the patient from Dr. Laski at this point; however, that was apparently the case. When the Respondent initially saw Patient #1 on October 22, 1986, the Respondent did not enter in his medical records information which would either affirm or negate the presence of a mass or nodule, as identified by Dr. Laski. The Respondent testified, however, that he felt something "because, here, I'm palpating something, yes." Because he felt something in the left testicle, the Respondent ordered a urinalysis. The urinalysis was a routine "dipstick" urinalysis without microscopic slide or culture evaluation for bacteria. The Respondent testified that he wanted the urinalysis as diagnostic information because he was "palpating something". He did the urinalysis by dipstick method, such that he was able to evaluate the color, quality, and specific gravity of the urine sample. The results were negative. Dr. Carmichael testified, however, that the Respondent should have gone farther and done a microscopic evaluation in which white blood cells, if present, could have been visualized in the urine sediment. Dr. Carmichael testified that a urine culture could have been performed even though the patient had already been through two different antibiotic courses, because, as it was the Respondent's feeling that the epididymitis had not yet been resolved, there was the possibility of the presence of a type of bacteria which had not been affected by the antibiotics already administered. According to Dr. Carmichael, if the culture grew out of a pathogenic organism, "you would then have a very good likelihood that that is a causative organism, and you could tell what drug to use." The urinalysis, however, as Dr. Carmichael established, would not rule out epididymitis. The microscopic urinalysis, if done, could have been normal and the culture could have been negative; and epididymitis could still have been present. However, the lack of these tests contributed to the Respondent's inadequate assessment of the patient's status. The Respondent had Patient #1 visit a second time on November 5, 1986. On the second visit, the Respondent found, and the medical records showed, that there was a small area of "prominence" (nodule) in the epididymis. The Respondent chose to continue to observe the patient, however, to continue the prescription of the anti-inflammatory medication and ordered the patient to return in one month. Dr. Carmichael opined that another diagnostic procedure could have been used with the patient, presenting in this status at this point in his treatment course, which could have helped differentiate whether there was actually a definite mass present or not. That is, the Respondent could have ordered an ultrasound test, a procedure which uses high-frequency sound waves to outline areas of soft tissue that will not be depicted on x-rays. Dr. Herold, the Respondent's expert witness, acknowledged that ultrasound could be ordered if there is some uncertainty in the doctor's mind about the diagnosis, although he opined that it would not be the usual procedure to order an ultrasound test when the doctor suspects epididymitis to be the problem. Here, the Respondent still felt comfortable with his diagnosis of epididymitis. However, in the face of Dr. Laski's finding on October 17, 1986 that there was some sort of nodule present and that he was uncertain enough to feel the need to refer the patient to a specialist, it was established by Dr. Carmichael that if the ultrasound had been ordered of the genital area, it could confirm the diagnosis of epididymitis or, correspondingly, whether an actual tumor was present at that time. In any event, the Respondent's treatment plan as of November 5, 1986 was to continue observation and order Patient #1 to return in one month. The patient failed to return until January 12, 1987, for unexplained reasons. On that date, the Respondent examined the patient and immediately noted a hard, non-tender mass in the area of the epididymis. The Respondent then immediately referred the patient to a urologist, Dr. Antar, who testified on behalf of the Petitioner. On or about January 19, 1987, Dr. Antar evaluated the patient and determined that surgery was immediately necessary, because his immediate impression was that the mass was cancerous. Blood tests revealed that the tumor markers were very high, and Dr. Antar felt that there was no reason to observe further. Three days later, Dr. Antar performed a radical orchiectomy on the left testicle (removal of the testicle). The testicular tumor was a teratoma. A teratoma is a tumor which appears to be benign but behaves like a malignancy. Moreover, however, a biopsy of a lymph node from the left side of the patient's neck showed three elements of cancer: the teratoma, embryonal cancer cells, and choriocarcinoma cancer cells. Dr. Antar established that all three indications were coming from the left testicle. Thus, the cancer had metastasized from the left testicle to the lymph system. However, Dr. Antar established that through chemotherapy the cancer cells which had migrated were eliminated, since this type of cancer, although it is virulent, is particularly amenable to chemotherapy. The medical records show that the Respondent saw the patient on three occasions; October 22, 1986, November 5, 1986, and January 12, 1987. The patient had also been seen by Doctor Laski independently of the Respondent for the first four visits and in conjunction with the Respondent's initial examination on October 22, 1986. Thus, Dr. Laski, before the Respondent, had seen the patient four times in three weeks. It was Dr. Laski's judgement that the symptoms of the acute problem had gone away but that, because a nodule remained which Dr. Laski could not explain, he should be referred to a urologist. The Respondent then took over his care for unexplained reasons but did not carry out Dr. Laski's recommendations for a urological evaluation by a specialist. The Respondent contended in his testimony that he would always honor another physician's recommendation but did not specifically indicate in his testimony or in the medical record why Dr. Laski's recommendation that a urologist be consulted and see the patient was not carried out. Even though, in fact, the Respondent noted in his subsequent examinations the prominence in the left testicle, he simply continued to diagnose the problem as epididymitis and elected to continue to "observe". The medical record prepared by Dr. Laski included the recommendation that the patient be referred to a urological specialist. Thus, the Respondent should have known of this recommendation whether or not he actually conversed with Dr. Laski about the referral (the record does not indicate whether they actually conversed about this subject or not). In any event, as shown by Dr. Carmichael, the Respondent's notes in the medical record do not provide any explanation or justification for merely continuing to observe the patient. The medical records prepared by the Respondent do not support his decision not to follow up and have the patient actually referred to a urologist and not to conduct further tests or investigation of the left testicle, such as an ultrasound test. Given the course of treatment by the Respondent, consisting merely of continuing to observe for another month, along with the continuing of a prescription for an anti-inflammatory, with the unexplained inconsistent deletion of the prescription for an antibiotic, even though the Respondent believed that the epididymitis was continuing; the medical record kept by the Respondent for the patient did not justify this course of treatment. He did not order any further diagnostic tests and yet, according to the record, ignored the recommendation that a specialist consultation be effected. All three of the medical experts testifying established that such a tumor could have initially presented as epididymitis. Dr. Carmichael opined that when a person has a lump or soreness in the testicle, he frequently tries to relate it to some type of activity, like lifting or straining. He opined that the usual presenting complaint of a testicular tumor would be a lump, with some sort of soreness or discomfort. Dr. Antar, the urologist who ultimately saw the patient and operated, testified that people with testicular cancer can present as having epididymitis. Dr. Antar testified that they need to be treated with antibiotics for two to three weeks, to be rechecked to be sure the epididymitis is dissolved and that the testicle has returned to normal. Dr. Herold also opined that the inflammation of epididymitis can occur as a result of trauma or as a reaction to the presence of a tumor. If the Respondent had such an awareness, as described by these experts, he did not act on it, however. He elected merely to continue the anti-inflammatory medication and part of the course of treatment already tried by Dr. Laski, in spite of the fact that his employee and colleague had already shown, and entered in his medical record, that the rest of the supposed epididymitis symptoms had disappeared, that there still remained a tenderness and small mass on the left testicle and that a consultation with a specialist was in order. Respondent's reaction upon first seeing the patient on October 22nd was that there was a tenderness in the left testicle and a swelling in the epididymitis, as well. The Respondent's testimony and his medical records simply do not explain why he ignored Dr. Laski's recommendation that a specialist see the patient and be consulted, if all he himself was going to do, at least for the ensuing one and one-half months, was to continue the anti- inflammatory therapy the patient had already been given.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners finding that the Respondent has violated Section 458.331(1)(t), Florida Statutes, as found and concluded above, for which a penalty of a $1,000.00 fine and one year's probation should be imposed. It is FURTHER RECOMMENDED that the Final Order determine that Section 458.331(1)(m), Florida Statutes, has been violated, for which the penalty of a reprimand and administrative fine in the amount of $500.00 be imposed. It is FURTHER RECOMMENDED that, as to both Counts, that 20 hours of continuing medical education in the area of oncology and five hours in the area of risk management, over and above that required for licensure, be imposed. DONE AND ENTERED this 5th day of April, 1994, in Tallahassee, Florida. P. MICHAEL RUFF 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 6th day of April, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-930 Petitioner's Proposed Findings of Fact: 1-8. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on the subject matter. Rejected, as subordinate to the Hearing Officer's findings of fact on the subject matter. 11-20. Accepted. Respondent's Proposed Findings of Fact: Respondent did not submit numbered proposed findings of fact and it is, therefore, difficult to rule on the proposed findings of fact specifically. Nevertheless, the first two paragraphs of the proposed findings of fact are accepted. The third paragraph is, for the most part, established by the evidence of record. However, it is rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter to the extent that they differ from the proposed findings of fact in the third paragraph in the Respondent's proposed findings of fact. The fourth paragraph of the Respondent's proposed findings of fact is accepted but not necessarily for the material import the Respondent proposes. COPIES FURNISHED: Barbara Whalin Makant, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Northwood Centre, Suite 60 Tallahassee, FL 32399-0792 James Facciolo, Esquire KENT, HAYDEN, ET AL. 200 West Forsyth Street Suite 1330 Jacksonville, FL 32202 Dr. Marm Harris, Executive Director Board of Medicine Department of Business and Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esquire General Counsel Department of Business and Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The administrative complaint charged Respondent in Count I with violating Section 458.331(1)(t), F.S., 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, and in Count II with violating Section 458.331(1)(m), F.S., failure to keep written medical records justifying the course of treatment of the patient, including but not limited to, patient histories, examination results, and test results.
Findings Of Fact At all times material, Respondent was a licensed medical physician in the State of Florida, having been issued license number ME004552. On October 24, 1988, Patient #1, a 67 year old female, presented by wheelchair at the Physicians Referral Center (PRC) emergency room of the Marion Community Hospital in Ocala, Florida. Respondent was on duty there at that time. Patient #1, arrived at the emergency room at approximately 1:50 a.m. complaining of gas, no bowel movements for three days, feeling weak, and a highly elevated blood sugar of 412 as of 5:00 p.m. the evening before. Patient #1 was accompanied by her husband, who provided some of the foregoing information. Alicia Ables, R.N., attended Patient #1 when she arrived, took her vital signs which appeared to be within normal limits, and noted in the patient medical records, at the bottom of the nurse's notes, that the patient had heart problems, diabetes, kidney problems, and was taking medications. The nurse attached to the patient's medical records a list of the patient's current medications which had been provided by the husband. These medications included Isordil, Trental, Ascriptin, Lasix, Lanoxin, Depyridamole, Capoten, Riopan Plus, Mylicon 800, Pilocarpine eye drops, Tylenol and Humulin N-100, 30 units in the morning and 6 units in the evening. Humulin N-100 is a low level prescription for insulin diabetic maintenance. Mylicon is an anti-gas preparation. The foregoing history was on the patient chart when Respondent saw the patient a few minutes later. Respondent saw the patient at approximately 2:10 a.m. At that time, only the patient, her husband, and Respondent were present in the examining room. No nurse was present in the examining room with them, but Ms. Ables testified that the absence of a nurse during a rectal examination of a female patient occurred occasionally if not regularly at PRC. Nurse Ables was not present in the examination room at the time of the examination and is without knowledge of the extent of Respondent's examination of Patient #1. The patient, who is now deceased, did not testify. The patient's husband did not testify. The only person who was present in the examining room on October 24, 1988 who did testify was Respondent, and his testimony is unrefuted that he performed a routine examination of the patient's chest, abdomen, and skin, that he also performed a rectal examination during which he found the patient's rectal vault "empty," and that he concluded that there was no fecal impaction but some retention of gas. He concluded that a soap suds enema was not warranted, given the patient's condition. He stated that despite believing that the patient had some retention of gas, he considered her to be "fixated" in her mind on the gas problem. When the Respondent examined the patient on October 24, 1988, he contemporaneously noted on her chart that her chief complaint was accumulation of gas, that she wanted a soap suds enema, and that she had spoken earlier with Dr. Sunkavalli, who had referred her to the emergency room. Dr. Sunkavalli was the patient's primary treating physician. Respondent also noted on the chart at 2:25 a.m. on October 24, 1988 that Dr. Sunkavalli would follow the patient as an outpatient. He also wrote down that he diagnosed her as having "gas retention fixation." He ordered Mylicon 80 to be administered to her. She was not given a soap suds enema, was not admitted to the hospital, and was not transferred to another hospital. Respondent did not order any laboratory tests or x-rays. Administration of the Mylicon 80 was noted on the patient's chart by a nurse other than Ms. Ables at 2:40 a.m. That nurse also noted on the patient records that Patient #1 was discharged home at 3:00 a.m., in stable condition. None of the typically observable symptoms of ketoacidosis in the patient were observed or noted by Respondent or by Ms. Ables while the patient was at PRC. Patient #1 was admitted to Citrus Memorial Hospital six and one-half hours after being discharged from Respondent's care. Three hours after her admission to Citrus Memorial, the patient died. After autopsy, the principal pathologic diagnosis and cause of death was listed as "marked three vessel artherosclerosis with large, old myocardial infarction." The gross summary reads, "Death of this 67-year old, white female was due to marked three vessel arteriosclerosis secondary to arteriosclerotic heart disease. A contributing factor was diabetic acidosis." There was also evidence of a gastro-intestinal bleed. When Patient #1's death became an issue the next day, Respondent was unable to recall the patient or his examination and treatment of her. The Respondent reviewed the emergency room records and spoke with Ms. Ables in order to recall the care he had rendered to the patient. Respondent prepared an addendum to the patient's medical records three days after he actually examined Patient #1. Only at that late date, October 27, 1988, did Respondent document a history, document that he had made a physical examination, and document that he had had a telephone consultation with Dr. Sunkavalli on October 24, 1988 while the patient was in the emergency room, and further document that he and Dr. Sunkavalli had concurred at that time in treating the patient with Mylicon. Adding the addendum was deemed appropriate under the circumstances by Marion Community Hospital personnel, and Petitioner's expert did not specifically find that adding it was inappropriate or improper. Respondent had not documented the telephone consultation with Dr. Sunkavalli or a history or physical examination of Patient #1 at the time he examined her on October 24, 1988. Neither on the date of examination/treatment nor in his later addendum did Respondent ever document that he had performed a rectal examination on Patient #1. In his testimony at formal hearing, Respondent explained and supplemented his October 27, 1988 addendum notation of a telephone conversation with Dr. Sunkavalli on October 24, 1988 to add that Dr. Sunkavalli was aware at that time of Patient #1's elevated blood sugar reading the previous evening but, hearing Respondent's examination results, Dr. Sunkavalli had recommended no further tests and had said nothing to disagree with Respondent's assessment and treatment of the patient and that while Respondent had not deferred to Dr. Sunkavalli, he had relied on the consultation. Dr. Sunkavalli was not called to corroborate or refute Respondent's testimony on this score. Jack Kareff, M.D., was accepted as an expert in emergency room medicine. He opined that, under similar circumstances, and particularly with an elderly diabetic patient, the minimal acceptable level of care, skill, and treatment of a reasonably prudent similar physician would have been to examine Patient #1's abdomen, perform a rectal examination, and perform a dipstick of urine for both glucose (sugar) and acetone. Dr. Kareff also expressed the opinion that the rectal examination should have been made to eliminate the chance of fecal impaction and that such rectal examination should have included treating a sample of fecal matter found in the rectal vault with a paper reagent to determine if there were occult blood in the patient's stool so as to rule out gastro-intestinal bleeding. Dr. Kareff testified that there is sufficient fecal matter for such a test in the rectal vault 99% of the time. He conceded that an enema might not be warranted and could be potentially traumatic, given such a patient's condition. Dr. Kareff indicated that the urine dipstick test should be done to ensure that the patient was not headed for diabetic ketoacidosis. The urine dipstick test proposed as a minimal requirement by Dr. Kareff was also described by him as actually "problematic" in that he admitted that such a dipstick test can "fool you" occasionally because not enough aceto acetate is formed to tell the patient's true condition. According to Dr. Kareff, ketoacidosis may take anywhere from 2 hours to several weeks to develop in a diabetic. On the foregoing information, the efficacy of a dipstick test was not established. Because he believed that Respondent had not done the abdominal examination, rectal examination with stool testing, and urine dipstick test, Dr. Kareff further opined that Respondent had fallen below the acceptable level of care, skill and treatment as recognized by a reasonably prudent similar physician under similar conditions and circumstances. In forming his foregoing opinions, Dr. Kareff had not had the benefit of hearing Respondent's unrefuted testimony that Respondent had, in fact, performed a rectal examination, determined that there was no fecal impaction, and found the patient's rectal vault empty. Accordingly, the record is devoid of Dr. Kareff's opinion, if any, as to what should have or could have been done as regards a fecal test when the patient's rectal vault is "empty." Dr. Kareff's opinions assumed and relied on some material contrary to the facts established in this proceeding. Dr. Kareff's opinion also relied upon much uncorroborated hearsay evidence, such as the agency's investigative report. These reliances and assumptions on Dr. Kareff's part detract from the weight and credibility of his opinion on minimal professional treatment, and therefore that opinion is not persuasive. The parties have stipulated that Respondent's medical records were inadequate. This stipulation and Dr. Kareff's opinion that Respondent failed to keep written medical records justifying the course of treatment are accepted.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Respondent is not guilty of violating Section 458.33(1)(t), F.S. and dismissing Count I of the Administrative Complaint; Finding that Respondent is guilty under Count II of the Administrative Complaint of violating Section 458.331(1)(m), F.S., failure to keep written medical records justifying the course of treatment of the patient, including but not limited to, patient histories, examination results, and test results; and Reprimanding Respondent for the single violation, fining him $1000.00, and requiring him to complete one basic level continuing medical education course in record keeping responsibilities and techniques within one year of the entry of the final order. DONE and ENTERED this 24th day of April, 1992, at Tallahassee, Florida. ELLA JANE P. DAVIS, 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 24th day of April, 1992. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-5014 The following constitute specific rulings pursuant to Section 120.59(2) F.S. upon the parties' respective proposed findings of fact (PFOF): Petitioner's PFOF: 1-12 Except as to subordinate, unnecessary or cumulative material, accepted. 13-14 Rejected because it is largely subordinate to the facts as found in FOF 18-21. 15 Rejected as a conclusion of law but also for the reasons set forth in FOF 18-19. Respondent's PFOF: 1 Covered in the preliminary statement, the FOF, or the Conclusions of Law. Accepted as covered in the rulings on Petitioner's PFOF. Rejected as legal argument. 4-6, 20-21, 37-38, 44, 46-48 Accepted but subordinate to the facts as found. 7-8 Covered in FOF 3-4. 9 Accepted with time adjustment per greater weight of the evidence. 10-11, 13-18, 22-24, 39-40, 45, 49-63, 66 Except as to subordinate, unnecessary, or cumulative material, accepted. 12 Accepted, except as to characterization "necessary". 19 Covered in FOF 17. 25 Covered in FOF 8. 26-28 Covered in FOF 18-21. 41-42 Covered in FOF 18-21. 29, 31 Rejected as irrelevant. 30 Covered in FOF 15. 32-36, 67 These proposals are irrelevant, out of context, or misleading as stated, since Dr. Kareff did not specifically advocate a soap suds enema and Respondent did not feel it was warranted. To the extent necessary, the subject matter is covered in FOF 7-9, 14-17, and 18-22. 43 Covered in FOF 7. 64-65, 68 Rejected as unnecessary and/or unproven. COPIES FURNIISHED: Louis Kwall, Esquire Gross and Kwall, P.A. 133 North Ft. Harrison Avenue Clearwater, Florida 34615 Susan E. Lindgard, Esquire Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
Findings Of Fact Dong Hack Koo, M.D., is a licensed physician in the State of Florida, having been issued license number ME 0027494. Koo was so licensed at all times material to the Amended Administrative Complaint. At all times material to this cause, Koo maintained an office at 121 East 8th Street, Jacksonville, Florida, 32206. On July 10, 1985, Diane Rabideau, an Investigator for the Department of Professional Regulation, inspected Koo's offices and found them to be unclean, with evidence of roach eggs present under a sink. Rabideau also found a rectal speculum and two vaginal speculums lying on a sink. Koo told Rabideau that the rectal speculum and the two vaginal speculums had been used. No evidence was presented to indicate how long the speculums had been on the sink. If such instruments are not cleaned quickly and properly following use, there is a high chance of spreading infection to the next patient to use the instrument. Such instruments should be placed in a cleansing solution and scrubbed, then wrapped and sterilized. It is the community practice to clean such instruments as soon as possible after use. According to Dr. Rosin, any physician who performs abortions in an unclean office with instruments lying around that have not been properly cleaned, has practiced below the community standard of care. However, no evidence was presented to show that Koo performed abortions under such circumstances. Koo does perform first trimester abortions in his office. It was not disputed that abortions are a medical and surgical procedure which can be dangerous. Emergency situations can arise during abortions and these emergencies require the presence of emergency equipment such as suction and the ability to start an intravenous medication. Koo does maintain suction equipment and intravenous solutions in his office. However, when possible he immediately transfers emergency patients to another facility. Koo does perform abortions in his office without the presence of an assistant to aid in emergency situations. According to Dr. Rosin, the standard of care in the community requires that an assistant be present during an abortion to assist the physician should an emergency situation arise. Additionally, according to Dr. Rosin, a physician who performs abortions without emergency equipment or without an assistant has failed to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. When Rabideau visited Koo's office on July 10, 1985, she obtained a sampling of drugs kept by Koo for dispensing to patients. The sampling revealed that a majority of the drugs had expired. However, no evidence was presented that this is a violation of Florida Statutes. Rabideau also found that Koo maintained a number of Schedule III, IV, and V, controlled substances in his office which he dispensed to patients. In dispensing these controlled substances, Koo used the instructions for use which are printed on the packaging. He also, at times, taped a small piece of paper to the packaging with his telephone number and the name of the patient. Koo did not completely label these controlled substances, which he dispensed, with his name and address, the date of delivery, directions for use, the name of the patient, and a warning concerning the transfer of the substance. Koo maintains no inventory of the scheduled controlled substances which are kept in his offices and dispensed to his patients. On August 6, 1985, Diane Rabideau again visited Koo's office. While Rabideau waited, a female patient by the name of Mary Green was seen by Koo and left with a prescription. Rabideau then asked Respondent to present the medical records on the patient, Mary Green. Koo was unable to present any medical records for the patient which he had just seen and to whom he had just dispensed medication. Koo's office procedure regarding patient medical records is to record histories and examination results on the patient medical records during the patient's visit. These medical records are kept in individual folders under the name of each patient. When a patient presents for treatment, the medical records for that patient are pulled and given to the doctor. After each visit, the patient's medical records are refiled. On or about March 16, 1986, pursuant to a subpoena from the Department of Professional Regulation, Koo provided the original medical records on ten (10) abortion patients. These original medical records were examined by John F. McCarthy, a questioned documents expert for the Florida Department of Law Enforcement. McCarthy's examination by electrostatic detection apparatus revealed that numerous indentations on the records superimposed with information from other records. For example, Exhibit 6 contained indentations from the writing on the face of Exhibit 10. Further, McCarthy found indentations on Exhibit 6 resulting from the writing on Exhibit 8. Thus, Exhibit 8 was on top of Exhibit 6 when it was prepared. Exhibit 8, however, is dated July 24, 1985, and Exhibit 6 is dated May 29, 1985. McCarthy's expert opinion is that at the time the various documents were prepared, they were on top of each other. It is therefore found that Exhibits 1-10, the original medical records on the ten named abortion patients, were not prepared at the time Koo saw the patients, but were instead all prepared at the same time, in response to the subpoena. It therefore must be found that the records were fabricated by Koo in response to the Department's subpoena. Prior to performing an abortion, a physician needs to verify whether the patient has Rh positive or negative blood type. The physician cannot rely on patients' representations that the Rh factor is positive or negative, but most obtain independent verification. This is because patients know that if they have Rh negative blood, they must receive a shot which is expensive. Koo relied on the patients' statements in ascertaining the Rh factor and did not obtain independent verification. In Dr. Rosin's expert opinion, the failure of a physician to obtain independent verification of the Rh factor poses a potential for harm to the patient and such failure is a failure to practice medicine with that level of care, skill, and treatment that is recognized in the medical community.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Medicine enter a Final Order finding Dong Hack Koo, M.D., GUILTY of violating Counts Two, Three, Four, Five, and Six of the Amended Administrative Complaint, and therein SUSPEND his license to practice medicine for a period of six (6) months during which he be required to successfully complete continuing education courses in maintaining, controlling, dispensing, labeling, and inventorying controlled substance, and in maintaining adequate patient records to justify the course of treatment. DONE AND ENTERED this 26th day of August, 1987, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-1066 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on the proposed findings of fact submitted by the parties in this case. Specific Rulings on Proposed Findings of Fact Submitted by Petitioner, Department of Professional Regulation Each of the following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parenthesis is the Finding of Fact which so adopts the proposed finding of fact: 1 (1) ; 2 (2); 3 (3); 4 (4); 5 (4); 6 (4); 7 (4); 8 (5); 9 (6); 10 (6); 11 (9); 12 (7); 13 (8); 14 (9); 15 (10); 16 (11); 17 (11); 18 (12); 19 (13); 20 (13); 21 (15); 22 (14); 23 (14); 24 (16); 25 (16); 26 (16); 27 (16); 28 (17); 29 (18); and 30 (19) That portion of proposed finding of fact 12 which concludes that Respondent does not maintain emergency equipment in his office is rejected as unsupported by the competent substantial evidence. COPIES FURNISHED: Ray Shope, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Dong Hack Koo, M.D. 121 East 8th Street, Suite 7 Jacksonville, Florida 32206 Dorothy Faircloth, Executive DIRECTOR Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joseph A. Sole, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
