Findings Of Fact The Petitioner is the state agency charged by statute with regulating the practice of medicine in Florida. At all times material to this case, the Respondent has been a physician in the state, holding Florida license number ME0031630. The Respondent is a well-trained vascular surgeon. During his residency, he served as chief resident at New York University. From 1982 to 1986, he taught surgery and was director of the hyperbaric chamber program at Einstein College of Medicine in New York. The Respondent moved to Tampa in 1988 and has worked as a general and vascular surgeon since his move. The Respondent is board certified in general surgery and has been recertified in his specialty. He has an excellent reputation as a surgeon. W. K., Patient number 1. At all times material to this case, Patient number 1 was a 51 year old male with a history of severe peripheral vascular disease including peripheral neuropathy and nephropathy, hypertension, coronary artery disease, severe atherosclerosis, insulin dependent diabetes, and bilateral leg swelling. On February 2, 1995, Patient number 1 was examined at University Community Hospital in Tampa, Florida. The examination revealed that no pulse was present at the popliteal level of either foot. Early gangrenous changes were present at the patient's right foot. Both feet were cold to the touch. Based on the February 2 examination, Patient number 1 was diagnosed with congestive heart failure secondary to ischemic heart disease, chronic renal insufficiency secondary to diabetic neuropathy, anemia, hypertension, peripheral vascular disease with early gangrenous changes to the right foot, and diabetic peripheral bilateral neuropathy in both extremities. On February 10, 1995, Patient number 1 was evaluated by the Respondent. Based on his review of the patient's arterial vascular studies, the Respondent recommended that the patient undergo "jump" bypass surgery. The patient had previously undergone bypass surgery and declined to do so again, electing instead to receive treatment by medical therapy. The medical therapy was unsuccessful. Patient number 1's right leg remained swollen and painful. The pain was persistent and severe, and interfered with his mobility. The Respondent was called for another consultation. On February 17, 1995, Patient number 1 presented to the Respondent for evaluation of the continuing pain in the lower right extremity. At that time, the patient and the Respondent discussed surgical amputation of the affected right extremity. The patient decided to undergo the amputation. Patient number 1 signed a consent for a right leg below knee, and possibly above knee, amputation. On any given day, multiple surgical procedures are performed in a hospital's surgical facilities. At Tampa Community Hospital, surgeries are scheduled by a clerk who enters the patient's information into the facility's records. The records are maintained on computers. The surgeries scheduled to be performed in the facility each day are identified on a printed surgical schedule which is generated from the computer records created by the clerk. For each surgery scheduled during the day, the surgical schedule identifies the assigned operating room, the surgical procedure, and the names of the patient, surgeon, and anesthesiologist. At University Community Hospital (UCH), the operating rooms are configured in a "U" shape. A control desk in the center of the "U" is staffed by an assistant nurse manager and a secretary. A copy of the printed surgical schedule is located at the control desk. Information from the surgical schedule is written onto a "blackboard" located at the control desk. The printed surgical schedule for February 20, 1995 incorrectly stated that Patient number 1 was to undergo a left below knee amputation. The evidence fails to establish the cause for the original incorrect identification of the procedure. At approximately 3:30 a.m. on February 19, 1995, Annette Beede, a pool nurse engaged in stocking and cleaning activities at UCH, received a telephone call from an unidentified person Ms. Beede identified as a floor nurse from the floor where Patient number 1 was housed. A pool nurse is one called in to fill a need for staff beyond the normal staffing levels of a hospital. The caller informed Ms. Beede that the surgery was incorrectly identified on the schedule. The caller told Ms. Beede that Patient number 1 was to undergo a right leg amputation. According to proper hospital procedure, any change to a surgical schedule must be submitted by the surgeon or his office. There is no evidence that the Respondent or his office was aware of or attempted to correct the erroneous surgical schedule. Ms. Beede corrected the copy of the surgical schedule she had and initialed her correction. Ms. Beede's corrected copy remained on a clipboard which was given to the nurse who relieved her from duty at about 11:00 a.m. on February 19, 1995. Ms. Beede did not verbally discuss the change with the relief nurse. There is no evidence as to why Ms. Beede was the nurse to whom the call was directed. Proper procedure for the change would be that the amended surgical schedule would remain on the clipboard at the control desk until it was taken into the operating room by the circulating nurse. At Tampa Community Hospital, multiple copies of surgical schedules were apparently made. Some circulating nurses had their own copies of surgical schedules. Copies of surgical schedules were also sometimes taped to walls in operating rooms or placed on operating tables. A separate and uncorrected copy of the February 20 surgical schedule was placed in the operating room where Patient number 1's procedure would be performed. The schedule placed in the room stated that Patient number 1's left leg was to be amputated. The blackboard at the control desk indicated that the patient's left leg was to be amputated. On February 20, 1995 at about the time Patient number 1 was being taken to the operating suite area, the Respondent was "making rounds" at the hospital. The Respondent was paged and told that Patient number 1 was being brought to the operating room. After hearing that the patient was on his way to the surgical area, the Respondent proceeded towards the lounge where surgeons generally wait to be called into the operating rooms. Patient number 1 was wheeled to an area just outside the operating room, where he was met by Willie Mae Jones, a circulating nurse. A circulating nurse is responsible for assuring that the surgical process operates smoothly. She is responsible for identifying the correct patient for surgery and for talking to the patient prior to surgery to ascertain his condition. Ms. Jones spoke to the patient and found him to be alert. She discussed the procedure. He identified his right leg as the correct amputation site. Ms. Jones noted the information provided by the patient in his hospital records. As Ms. Jones talked to the patient, the Respondent passed nearby, waived to the patient, and entered the lounge area. On February 20, 1995, the Respondent did not discuss the procedure with the patient prior to the surgery. The effective standard of care did not require the Respondent to speak to the patient at that time. Prior to the surgery, Ms. Jones was responsible for "prepping" the appropriate area for surgery. In this case, prepping included cleaning the leg with an antiseptic solution. A leg holder was used to position and stabilize the leg prior to cleaning. The patient's left leg was edemous and ulcerated. At Ms. Jones' direction, her assistant placed the patient's left leg in the holder. In preparing a patient for an amputation, the appearance of an extremity, without additional review of records, is not an appropriate indicator of whether it is the correct extremity to be amputated. After the leg was secured, it was removed from the leg holder at the direction of the nurse anesthetist in order to permit the spinal anesthesia to take effect. After the patient was anesthetized, the anesthesiologist replaced the left leg into the holder. Ms. Jones prepped Patient number 1's left leg. The rest of the patient's body, including his right leg, was draped with a sheet or blanket. After the administration of anesthesia was complete and the patient was draped, the Respondent, having finished scrubbing, entered the room and the surgical procedure began. Normally, operating room personnel work from 7:00 a.m. to 3:00 p.m. By the time the amputation of Patient number 1's leg began, it was 5:45 p.m. The Respondent had reviewed the incorrect blackboard information and the incorrect written surgical schedule prior to the surgery. The effective standard of care did not require that the Respondent review the patient's medical records or the executed consent form prior to the surgery. He did not review the documentation. As the surgery began, the nurse anesthetist inquired as to the pre- operative diagnosis. The Respondent replied "ischemic left lower extremity." Ms. Jones recorded the Respondent's statement in the appropriate position on the patient's surgical record. While the operation was in progress, Ms. Jones recorded the surgical procedure as a "left below knee amputation," based on the information provided by the Respondent to the surgical team during the procedure. While the Respondent was amputating the patient's lower left leg, Ms. Jones began to review Patient number 1's medical records. She noticed that the patient's medical history and consent identified the correct amputation site as the patient's right leg. Ms. Jones, who had been facing away from the operating area of the room, turned towards the area where the surgery was taking place. She looked under the draped blanket. She began to cry and the surgical team then discovered that the wrong leg was being amputated. After a momentary pause, the amputation, having passed the stage at which it could have been reversed, was completed. After the patient was sufficiently recovered from the surgery, the Respondent entered the recovery area and discussed the mistake with the patient. The patient was subsequently transferred to Tampa General Hospital where his right leg was amputated. Prior to it's amputation, the patient's left leg was also affected by poor circulation. There is evidence that the condition of the patient's left leg was as deteriorated as that of his right leg. He had previously been treated for left leg pain. It is likely that at some future point, Patient number 1's left leg would have required additional treatment and possibly amputation. Notwithstanding the condition of the left leg, at the time it was amputated, Patient number 1 relied on it for mobility. There is no evidence that the Respondent and Patient number 1 discussed amputation of any portion of the patient's left leg. The applicable standard of care requires that a surgeon verify that the appropriate site is prepared prior to surgery and that the correct surgical procedure is performed. On February 20, 1995, the Respondent failed to meet the standard of care by failing to verify that the appropriate site had been prepared for surgery and by amputating the incorrect extremity. The applicable standard of care requires that a surgeon obtain the written consent of a patient prior to performing a surgical procedure. On February 20, 1995, the Respondent failed to meet the appropriate standard of care by performing a surgical procedure for which he did not have the written consent of the patient. Although there is evidence that errors by persons other than the Respondent contributed to the amputation of the improper extremity, there is no credible evidence to establish that such errors excuse the Respondent's failure to meet the appropriate standard of care. M. S., Patient number 2. At all times material to this case, Patient number 2 was a 69 year old female with a history of diabetes, end stage renal failure requiring hemodialysis, pericarditis, severe peripheral vascular disease, and osteomyelitis. Osteomyelitis is an infection which results in the decay of bone mass and soft tissue. In 1993, four toes of Patient number 2's left foot had been amputated due to infection and to osteomyelitis. The infections were a result of her diabetes and poor vascularization to the affected tissues. At all times, Patient number 2 was very concerned about keeping her limbs intact and was extremely resistant to amputation of her legs. The previous toe amputations were an attempt to maintain the integrity of her limb. On April 11, 1995, the Respondent amputated the fifth toe from Patient number 2's right foot. She was suffering from inoperable vascular disease in her right leg. The toe was necrotic and infected. The April 11th amputation was performed using typical amputation technique. An elliptical incision was made at the base of the toe, the bleeding was controlled, the bone was cut through above the metatarsal head, tendons were sliced and the toe was removed. Sutures were used to close the wound. The toe removed during the April 11th amputation was sent as one piece to the hospital pathology department. After the amputation of the fifth toe, the patient's infection continued. On June 30, 1995, she was admitted to Town and Country Hospital in Tampa, Florida. At the time of her admission, she was suffering from spiking fever related to the infection in her right foot. Upon examination, the Respondent determined that the site of the amputation was necrotic and infected. A foul smelling fluid drained from the wound. The foot was swollen. An x-ray revealed abnormality in the area of the right fourth toe. There were erosions around the area of the toe indicating likely infection and osteomyelitis. The Respondent performed a limited removal of necrotic tissue at the patient's bedside and ordered tests and medical treatment to confirm the condition. The patient's physicians were concerned that the infection would become more pervasive and could cause increasing medical problems. The Respondent discussed Patient number 2's condition with other physicians who were involved in her care. The possibility of a right below knee amputation was discussed with the physicians as was the removal of the remaining toes from her right foot. The Respondent believed that removal of her remaining toes was not appropriate because the right foot was not viable. Patient number 2's primary care physician spoke with her about the need to resolve the continuing infection in her right foot and discussed below knee amputation of the leg. She remained very concerned about losing her leg and emphasized to her physician that she wanted to save the limb. The patient's physician discussed with the Respondent a transmetatarsal amputation, involving removal of part of her right foot. However, given the vascular problems in her right leg, the Respondent determined that the procedure would be unlikely to heal adequately. The Respondent discussed amputation with Patient number 2, who declined to have her leg amputated. The Respondent then discussed debridement of the right foot with the patient. Debridement is a procedure where necrotic tissue is surgically removed by a scalpel or scissors. The debridement of tissue requires exercise of the surgeon's clinical judgement and discretion. Ideally, a surgeon removes necrotic material to the point where normal bleeding begins to occur. In this case, the purpose of the debridement was to remove the necrotic tissue and attempt to restrain the infection. On July 6, 1995, Patient number 2 executed her consent to a debridement of her right foot. There is no credible evidence that the Respondent discussed with the patient the removal of the fourth toe on her foot during the debridement. The debridement was scheduled for July 7, 1995, but was postponed when the patient developed pneumonia. On July 10, 1995, the debridement was again discussed by the Respondent with the patient, who remained in emotional turmoil and was concerned about saving her foot and leg. On July 10, 1995, the patient met with an infectious disease doctor who noted an increased white blood count (indicating an active infection) and a non-healing wound which displayed necrotic changes. The desirability of a transmetatarsal amputation was again discussed, because the physician believed antibiotics would be insufficient to control the infection. Again the patient declined the amputation. The debridement was scheduled for July 11, 1995. On that day, a surgical nurse, Margaret Pratt, spoke to the patient about the procedure. The patient said the Respondent was to remove dead tissue from her foot. Ms. Pratt saw that the toe appeared to be necrotic and marginally attached to the foot. Based on her view of the toe, Ms. Pratt discussed with the Respondent whether she needed to obtain the patient's consent for removal of the toe. The Respondent said he was not going to amputate the toe. Continuing to be concerned, Ms. Pratt spoke to her supervisor, Kathy Dzikowski, about the condition of the toe and the Respondent's intentions. Ms. Dzikowski contacted the Respondent to discuss his intentions. He continued to indicate that he planned only to debride the foot. Another nurse, preparing for the procedure, asked the Respondent if he needed a large "Horsley" bone cutter. He replied that he did not need a large bone cutter. On July 11, 1995, the debridement procedure was performed. Using a number 10 blade scalpel, the Respondent removed necrotic tissue from the bottom and then from around the "ball" of the patient's right foot. The Respondent also debrided the right side of the patient's right fourth toe. The Respondent then prepared to debride the left side of the toe. Holding the blade in this right hand, and grasping the fourth toe with his left hand, the Respondent pulled the toe to the right to access the area between the third and fourth toe, in order to debride the left side of the fourth toe. As he grasped the toe, the bone of the toe disconnected from the metatarsal joint and was connected only by tendon and necrotic tissue. There is no evidence that the toe was in proper condition to be saved. Using the scalpel, the Respondent cut the tendon and removed the toe. After the toe was removed, the joint and bone were exposed from the wound. The Respondent took a small clipper called a "ronguer" and removed the top of the metatarsal joint. The ronguer is part of the standard set of surgical instruments which is set out for use during debridement. The removal of the bone was medically indicated, given the condition of the foot. After the toe was removed, the toe was handed to Ms. Pratt, who was receiving the debrided tissue at a table facing away from the operating site. She inquired as to how to label the material. The Respondent told her to label it as "debridement of right foot." Because the toe was visibly a toe, he assumed that she was referring to the remaining tissue which had been removed. Apparently assuming that the Respondent was attempting to conceal the removal of the toe, Ms. Pratt asked her supervisor how the tissue should be labeled, and was told to label it as "toe and debridement." There is no credible evidence that the Respondent attempted to conceal the fact that a toe had been removed. The toe was clearly identifiable and visible in the debrided material. Everyone in attendance at the surgery was aware that the toe had been removed. After the removal of the necrotic toe, the Respondent continued the debridement and completed the procedure. Immediately following completion of the procedure, the Respondent dictated his operative report, which identified the procedure as "debridement of right foot and amputation of fourth toe." After the patient recovered from the procedure, the Respondent discussed the procedure with her. He told her that her toe had fallen off (or words to that effect) during the debridement. He also discussed the manipulation, dislocation and subsequent removal of the toe. It is reasonable for a physician to speak to a patient in non-medical terminology in order to provide information which can be easily understood by the patient. The evidence fails to establish that the Respondent attempted to conceal the nature of the procedure from the patient. All of the tissue removed from the patient, including the toe, was sent to the hospital pathology department for examination. There is no evidence that the Respondent attempted to obstruct or prevent the delivery of any debrided material to pathology. Pathological review of the toe is consistent with debridement performed by sharp dissection; however, the toe joint reveals no sharp dissection other than at the metatarsal head, which was removed by clippers after the dislocation and removal of the digit. A toe amputation generally results in a one-piece specimen as the toe is usually removed by cutting through the bone above the metatarsal joint. The specimen in this case was in two pieces, the piece that disconnected from the joint, and the joint section which was cut off by the Respondent after the dislocation and removal of the digit. The technique used in the July 11, 1995 procedure was not standard for amputation. The Respondent removed the necrotic tissue from the toe. There is no reason to have debrided the toe had he planned to remove it entirely. The toe was not removed using bone cutters. The evidence fails to establish that the Respondent intended to amputate the toe prior to beginning the debridement procedure on July 11, 1995. The evidence establishes that due to the condition of the patient's foot, the Respondent should have known that the toe could become disconnected and should have obtained the patient's consent for removal of the toe, if and when the disconnection occurred. It would be reasonable to consider, given the patient's osteomyelitis, that during the debridement, the toe bone could have fractured, or that the tissue, tendon, fascia and capsule of the toe could be eroded or weakened, resulting in dislocation or separation of the toe from the normal anatomic position. According to an expert for the Respondent, a planned debridement resulting in an amputation of the toe after it disengages or dislocates is not unique, and in fact has occurred in his personal experience. The Respondent did not discuss with the patient the possibility that the toe could disconnect and have to be removed during the procedure. The standard of care for obtaining surgical consent requires that a surgeon discuss the risks and benefits of an operative procedure with the patient. In this case, although the Respondent discussed the risks and benefits of the surgery with the patient, he did not address the possibility that the necrotic toe could become disconnected and have to be removed. The consent form executed by Patient number 2 does not authorize the Respondent to amputate the toe if it detached from the foot during the debridement. Although the consent form authorized by the patient permitted the Respondent to act beyond the boundaries in the event of "unusual circumstances," the evidence fails to establish that the disconnection of a necrotic toe during the debridement of this patient's right foot can reasonably be identified as an unusual circumstance. The Petitioner asserts that at the time the toe became disconnected, the surgical procedure should have been halted, the patient allowed to recover and that the Respondent should have obtained the patient's consent to remove the detached necrotic toe. Given the circumstances of this case, the Petitioner's assertion is unreasonable. After the debridement, the condition of the patient's did not improve. It remained infected and necrotic. Eventually, a right below knee amputation was performed on Patient number 2.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order determining that Rolando Roberto Sanchez has violated Sections 458.331(1)(p) and (t), Florida Statutes, and suspending his license for a period of two years from the date of the Emergency Order of Suspension, imposing a fine of $15,000 and placing the Respondent on probation for a period of five years from the date upon which the suspension expires. Further, during the period of probation, the Respondent shall not perform any surgical procedure without the direct supervision of a licensed physician who, prior to the commencement of the surgery, shall certify that the anatomical site which has been prepared for surgery is correct. DONE and RECOMMENDED this 19th day of October, 1995, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM 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 19th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-3925 To comply with the requirements of Section 120.59(2), Florida Statutes, the following constitute rulings on proposed findings of facts submitted by the parties. Petitioner The Petitioner's proposed findings of fact were inappropriately numbered and set forth in separate sections. For purposes of the following, the proposed findings have been re-numbered consecutively beginning from the section titled "FACTS," and are accepted as modified and incorporated in the Recommended Order except as follows: 20-21. Rejected, subordinate. 22. Rejected as to "good medical practice" of cited witness, irrelevant. 30. Rejected as to Ms. Pratt's expertise or knowledge which would establish that the toe "would come off" if the foot were touched, not supported by the greater weight of the evidence. 33-34. Rejected, not supported by the greater weight of credible and persuasive evidence. The implication is that the Respondent requested that the witness obtain a "Horsley" bone cutter to permit removal of the toe. The evidence fails to establish that a Horsley bone cutter was obtained by the witness, notwithstanding her assertion that the Respondent directed her to do so. The evidence fails to establish that the witness could clearly view the procedure. The witness did not see the toe being debrided prior to the toe's dislocation from the foot; however, the evidence establishes that the toe was debrided. 35. Rejected, cumulative. Rejected, contrary to the greater weight of credible and persuasive evidence. Rejected, irrelevant. There is no credible evidence that in postoperative notation, the Respondent attempted to conceal the surgical procedure performed on Patient number 2. The cited witness acknowledged that her recollection of the conversation with the Respondent was not an exact quoting of his remarks. Rejected, immaterial. There is no credible evidence that the children were authorized to consent to any procedure on behalf of the patient. Rejected, contrary to the greater weight of credible and persuasive evidence. Rejected, recitation of testimony is not finding of fact. Rejected, subordinate. 45. Rejected, recitation of testimony is not finding of fact. 46-47. Rejected, cumulative. Rejected, recitation of testimony is not finding of fact. Rejected, cumulative. Rejected, recitation of testimony is not finding of fact. Rejected, unnecessary. 52-53. Rejected, recitation of testimony is not finding of fact. Respondent The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 8. Rejected, unnecessary. Goes to the credibility of his testimony which has been determined in, and is reflected by, the Findings of Fact set forth herein. 10-11. Rejected, subordinate. 22. Rejected, subordinate. 23-24. Rejected, irrelevant. The evidence fails to establish that such "reasonable reliance" relieves a surgeon of responsibility for performance of an improper procedure. 26. Rejected as to assertion that "ninety percent" of Florida surgeons "would have made the same mistake," not supported by credible evidence. 31-33. Rejected, subordinate. Rejected. There is no evidence that on February 20, 1995, the Respondent performed any review of medical records or examined the patient whatsoever prior to beginning the surgery. Rejected, unnecessary. 42. Rejected, not supported by the weight of credible and persuasive evidence. 43-48. Rejected, cumulative. 51. Rejected as to race of patient, immaterial. 63. Rejected, irrelevant. 66-70. Rejected, cumulative. Rejected, subordinate. Rejected, recitation of testimony is not finding of fact. Rejected, subordinate. Rejected, recitation of testimony is not finding of fact. Rejected, irrelevant. There is no credible evidence as to Ms. Pratt's knowledge that the toe "might fall off" of the foot. Rejected, recitation of testimony is not finding of fact. Rejected, subordinate. Rejected, recitation of testimony is not finding of fact. 105-107. Rejected, subordinate. 108-110. Rejected, unnecessary. 112. Rejected, contrary to the greater weight of credible and persuasive evidence. Rejected, cumulative. Rejected, contrary to the greater weight of credible and persuasive evidence. 120-121. Rejected, contrary to the greater weight of credible and persuasive evidence. There is no credible evidence that the patient was told that the toe could dislocate and require removal during the debridement, or that "debridement of a right foot can include removal of digits, including portions of the mid-foot." 122. Rejected, contrary to the greater weight of credible and persuasive evidence which establishes that the disarticulation was not unique or unpredictable. 125-127. Rejected, immaterial. 128-141. Rejected, unnecessary, irrelevant. These proposed findings are based on Respondent's Exhibit number 13, a collection of Final Orders issued by the Petitioner (or a predecessor agency) wherein various physicians were the subject of disciplinary action. None of the cited cases involved the incorrect and complete surgical amputation of an extremity, or involve the failure to reasonably anticipate the possible complications of a procedure and the failure to obtain consent from the patient to resolve the complication. The cited cases involve factual situations sufficiently distinguished from those at issue in this case. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Steven Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Michael K. Blazicek, Esquire STEPHENS, LYNN, KLEIN & McNICHOLAS, P.A. 4350 West Cypress Street, Suite 700 Tampa, Florida 33607
The Issue The issue is whether Respondent failed to practice medicine with the required standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and failed to keep required written medical records, in violation of Section 458.331(1)(m), Florida Statutes. If so, an additional issue is what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician in Florida, having been issued license number ME 0022608. Respondent is board-certified in ophthalmology. He was the principal investigator in the Excimer Laser Research Study. He is a fellow with the American College of Surgeons. He has published extensively in prominent medical and ophthalmologic journals. While still receiving medical training, Respondent gained experience in treating the ophthalmologic conditions of patients who suffer from Down Syndrome. While in practice, Respondent has continued to gain considerable experience in treating the ophthalmologic conditions of patients with Down Syndrome. Respondent has never previously been disciplined. U. V. was born on January 6, 1973. He suffered from Down Syndrome. As a young child, U. V. was diagnosed with inoperable congestive heart failure. Suffering from damage to two chambers of his heart and irreversible lung damage, U. V. had been in “terminal” condition since about the age of seven. Despite his serious medical problems, which are common to Down Syndrome patients, U. V. was a happy young man, who developed and matured as a teenager. He communicated his feelings and interacted with others, especially with his family. His mother adopted him when he was about five years old; previously, she had cared for him after his biological family had abandoned him. In March 1992, U. V. became quite ill. His physician discussed with U. V.’s mother the possibility of a Do Not Resuscitate order, but no order was ever given or entered into his medical records. U. V. rallied from his illness. His cardiologist found, after an office visit on October 13, 1992, that U. V. had made “tremendous progress” and was “doing quite well at this point in time.” This was the last time that U. V. visited his personal physician prior to the cataract surgery nearly a year later. In April of 1993, U. V. received home health care through the Hospices of Palm Beach. During this time, the hospice nurse who visited U. V. at home noted that he was sensitive about his Down Syndrome and social isolation. On July 14, 1993, the hospice nurse noted that she found U. V. to be “alert, ambulatory, cheerful.” U. V.’s mother told the nurse that U. V. wanted an eye surgeon to treat a cataract that had developed in his left eye, and the family would be willing to pay for the operation in installments, if health coverage would not pay for the surgery. Ten days later, during another home visit by the hospice nurse, U. V.’s mother again stated her concern about his cataract. The nurse told her to take U. V. to his primary care physician for a referral. U. V.’s family took U. V. to his family physician, who sent him to an optometrist. The optometrist determined that U. V. had a cataract in his left eye and was starting to develop one in his right eye too. The optometrist told them that surgery could correct the condition and referred U. V. to Respondent. About a month later, in late August, U. V.’s mother informed the hospice nurse that they had an appointment with an eye surgeon and hoped that he would remove the cataract from U. V.’s left eye. At this time, U. V. was still leading an active life, largely due to the support and assistance of his loving family. He was happy and enjoyed dancing at weddings and parties and watching television. The family thought that surgery would help him see better with his left eye. Respondent first examined U. V. on August 31, 1993. He found a hypermature cataract in U. V.’s left eye. U. V.’s eye was totally opacified by the cataract to such an extent that he could see only hand motion. Respondent was immediately concerned with the possibility of phacolytic glaucoma. This is a condition in which the cataract liquifies and may leak through the lens capsule, resulting in an immunological reaction. Phacolytic glaucoma is extremely painful. It is impossible to predict the precise onset of phacolytic glaucoma, but Respondent reasonably determined that the condition could develop in as little time as hours or days, although it was possibly months away. Respondent was also concerned with U. V.’s right eye. Respondent found a cataract in the right eye in the lens where all the light rays pass into the eye. This type of cataract advances rapidly, so much so that it might overtake in seriousness the older cataract in U. V.’s left eye. Respondent performed a comprehensive examination of both eyes. He discussed cataract surgery with U. V.’s mother. Respondent agreed to perform the surgery for the Medicaid payment. He carefully explained the condition of U. V.’s left eye and the risks and benefits of surgery and general anesthesia. To assist in communicating with U. V.’s Spanish-speaking mother, Respondent had someone in the office translate for the mother. After hearing the explanation, U. V.’s mother agreed to the surgery, and Respondent set up the surgery for September 7, 1993. After returning home, U. V. began complaining of problems with his right eye. His sight was deteriorating at this time, heightening his feeling of isolation from the world around him. In the meantime, Respondent had the laboratory work done in preparation for the surgery. His office contacted U. V.’s physicians to get medical information in preparation for the cataract surgery. But they were unable to get such information from the physicians’ offices. On September 7, U. V. and his family returned to Ft. Myers for the surgery. The board-certified anesthesiologist examined U. V. and found that he had wheezing respiration, so the anesthesiologist told Respondent that the surgery had to be postponed. Respondent rescheduled the surgery for September 15, 1993. Respondent and the anesthesiologist then discussed the possibility of using a local anesthetic, which would present fewer risks to U. V. than would be posed by a general anesthetic. But, as is typical with Down patients, U. V. had been fidgety during the August 31 office visit and was a poor candidate for local anesthesia during the extremely delicate cataract surgery that he was about to undergo. Respondent and the anesthesiologist agreed that U. V. would receive general anesthesia for the surgery. After the first surgery was canceled, the anesthesiologist undertook the task of obtaining the medical clearances for general anesthesia. He spoke with U. V.’s primary physician, who practices in the small town where U. V. lived at the south end of Lake Okeechobee between Clewiston and Belle Glade. U. V.’s primary physician appeared as a witness at the hearing. He seemed to suffer from communication problems not entirely attributable to obvious difficulties with the English language. Not surprisingly, the anesthesiologist obtained little useful information from the physician. The anesthesiologist’s nurse called the cardiologist’s office several times on September 15 prior to the surgery. Unable to reach the cardiologist or any of his partners, the anesthesiologist spoke with one of the cardiologist’s office nurses and had her read him U. V.’s chart. Especially interested in U. V.’s cardiac malformations, the anesthesiologist satisfied himself that U. V. could withstand the rigors of general anesthesia and developed a plan, after discussing the case with his partners, to use special drugs and techniques so as to affect V.’s heart and lungs as little as possible. The anesthesiologist also studied either a chest xray taken on September 6, 1993, or a report of the chest xray taken on that date. He examined the xray or report to determine if U. was suffering from any reversible heart problems that might resolve themselves if surgery were postponed. The anesthesiologist found no cardiac problems of this type. Prior to the administration of the general anesthesia, the anesthesiologist spent several hours with U. V. and his family discussing the risks and benefits of general anesthesia. U. V.’s mother accepted the risks and agreed to the use of the general anesthesia. U. V.’s cardiologist testified that, if asked about the surgery and general anesthesia, he would have cautioned Respondent and the anesthesiologist of the risks of surgery, but he would not have offered an opinion on the advisability of using general anesthesia on U. V. The cardiologist would have left the decision on this matter to the anesthesiologist. On September 15, 1993, Respondent removed the cardiac from U. V.’s left eye. The surgery was flawless. During the surgery, U. V. was stable and tolerated the anesthesia. Following the surgery, U. V. awoke in the recovery room, where he was alert and following commands. Once U. V. began to breathe better on his own, the ventilator machine was turned off. U. V. suddenly developed cardiac arrhythmia and died within an hour. Respondent did not deviate from the applicable standard of care in his diagnosis and treatment of U. V. Respondent’s medical records amply memorialize his diagnosis and fully justify the surgery undertaken on September 15, 1993.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the administrative complaint against Respondent. ENTERED in Tallahassee, Florida, on June 4, 1997. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings on June 4, 1997. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 John F. Lauro, Esquire John F. Lauro, P.A. Suite 3950 101 East Kennedy Boulevard Tampa, Florida 33602 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0972 Jerome Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
