The Issue The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney. In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney. The point of entry is on the lower back of the patient. T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However, T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry. Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he needed to confirm by x-ray the location of the stent at the end of the tube.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 2nd day of August, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 1999. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue is whether Respondent is guilty of performing wrong-site surgery or performing a procedure without the patient's consent and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been licensed as a physician in the state of Florida. His license number is ME 85786. Respondent is Board-certified in anesthesiology and pain management by the American Board of Anesthesiology. Respondent has not previously been disciplined by the Board of Medicine. Patient K. D. suffered a back injury in November 1998. Following a laminectomy, Patient K. D. continued to suffer from chronic low-back pain. She visited Respondent's pain management clinic for pain relief and has been quite satisfied with the treatment that she has received from Respondent. On February 14, 2003, one of Respondent's partners performed a right-side lumbar rhizotomy by pulsed radiofrequency. The purpose of this procedure is to relieve or eliminate pain in the lower back. When performed by pulsed radiofrequency, the rhizotomy would probably not have been successful if the patient still experiences pain two weeks after the procedure. Two weeks later, on February 28, Patient K. D. presented for a left-side lumbar rhizotomy, which Respondent was to perform. Immediately prior to the surgery on February 28, while Patient K. D. was in pre-op, Respondent performed a physical examination and observed that Patient K. D. indicated pain on the right side. In response to questioning, Patient K. D. confirmed that her right side was more painful than her left side. Respondent said that he would therefore perform a right-side lumbar rhizotomy. Patient K. D. did not disagree or object, but consented to the procedure--in the presence of two nurses, as well as Respondent. Immediately after their pre-op discussion, Patient K. D. was administered Versed, which produces an effect of amnesia. To some extent, this drug may cause some retrograde amnesia, so that Patient K. D. might not recall events immediately preceding the administration of the drug, such as her physical examination and conversation with Respondent in pre-op. Respondent performed a right-side lumbar rhizotomy without incident. However, immediately after the procedure, Patient K. D. said that she also suffered left-side pain and questioned why Respondent had performed the procedure on her right side. When Patient K. D. complained that transportation problems would make it hard for her to re-schedule a left-side procedure, Respondent performed a left-side procedure, on the same day, and he completed this procedure also without incident. Prior to the February 14 and 28 procedures, Patient K. D. signed consent forms. The consent form for the February 14 procedure identifies a right-side procedure, and the consent form (actually, there are two identical forms) for the February 28 procedure identifies a left-side procedure. The forms state: It has been explained to me that during the course of an operation, unforeseen conditions may be revealed that necessitate an extensive exchange or change of the original procedure or different procedures, and I therefore authorize and require my physician or surgeon . . . to perform such surgical procedures as are necessary and desirable in the exercise of his and/or their professional judgement. . . . Petitioner's expert witness opined that a change in location, even under the above-described circumstances, "should" have been documented on a consent form, but later conceded that this is not strictly necessary. On cross-examination, Petitioner's expert witness admitted that a patient may give informed consent verbally or by conduct. Petitioner's expert witness properly discredited Respondent's theory that he had some form of ongoing consent because the forms bore no expiration date. However, to the limited extent that Petitioner's expert witness implied a requirement for written informed consent, his opinion is unsupported by Florida law, as set forth below. In contrast to Petitioner's expert witness, Respondent's expert witness did not equivocate on the issue of the required form of informed consent. Relying largely on the testimony of Patient K. D., Respondent's expert witness testified that Respondent had obtained the informed consent of Patient K. D. to perform a second right-side procedure. Aside from the obvious advantages of a written informed consent, Respondent's expert witness convincingly testified that informed consent is a state of mind, not a signature on a piece of paper, and, by this standard, which is consistent with Florida law, as set forth below, Respondent had Patient K. D.'s informed consent to perform a second right-side procedure on February 28 and thus had been duly authorized to do so.
Recommendation It is RECOMMENDED that Petitioner dismiss the Administrative Complaint, as amended, against Respondent. DONE AND ENTERED this 21st day of November, 2005, in Tallahassee, Leon County, Florida. S _ ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 21st day of November, 2005. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Irving Levine Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Dennis A. Vandenberg Peterson Bernard 1550 Southern Boulevard West Palm Beach, Florida 33406
