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
The Issue Whether Respondent, a physician, committed the offenses alleged in the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact At all times pertinent to this proceeding, Respondent was a licensed physician in the State of Florida (license number ME 0031217) who practiced in the specialty of orthopedic surgery. Respondent was not board certified. At all times pertinent to this proceeding, Respondent had hospital privileges at Palm Springs General Hospital (Palm Springs) in Hialeah, Florida. On Saturday, February 26, 1994, T. P., a 29 year-old male, suffered a badly fractured leg while playing soccer. T. P. was taken to the emergency room at Palm Springs where the emergency room physician partially reduced the angulation of the fracture and placed the patient's leg in a splint cast. The patient was thereafter admitted to Palm Springs on February 26, 1994, under the care of Dr. Stephen Ticktin, an orthopedic surgeon. X-rays revealed that the patient had sustained a jagged fracture of both the tibia and the fibula. The fractures were similar to sharp-edged spears. There was a laceration and significant bruising at the fracture sight. Dr. Ticktin examined the patient's leg on February 26, 1994, but did not reduce the fracture (set the leg) on that date. Instead, Dr. Ticktin kept the leg in the splint cast to immobilize it, and planned to perform surgery on the following Monday morning. The patient and his girlfriend told Dr. Ticktin that they did not want to have surgery at Palm Springs. They wanted the patient transferred to a Broward County hospital so that he could be closer to his residence. On Monday, February 28, 1994, Dr. Ticktin did not perform surgery on T. P. On Monday, February 28, 1994, T. P. changed his mind and agreed to have surgery at Palm Springs. (Dr. Ticktin's notes reflect that the patient changed his mind after talking to a representative of his insurance company.) Surgery was planned for Wednesday, March 2, 1994. On that Wednesday, the patient ran a fever. Because of that fever, the anesthesiologist cancelled the surgery that had been scheduled for March 2, 1994. The patient terminated the services of Dr. Ticktin on March 2, 1994, and refused to be treated by him. Late in the day of Wednesday, March 2, 1994, the hospital administrator asked Respondent to assume the care of the patient. Respondent first saw the patient between 10:00 p.m. and 11:00 p.m. on Wednesday, March 2, 1994. At the time Respondent first saw him, T. P. had been immobile with the cast that Dr. Ticktin had placed on his leg on February 26, 1994. His fractured leg had not been set. The patient was very upset. On the evening of March 2, 1994, Respondent determined that the fracture would have to be reduced with the patient being under general anesthesia. Respondent observed that the leg did not appear to be excessively swollen and that the circulation in the leg was appropriate. Respondent noted that there was numbness in the foot, which indicated that a peritoneal nerve had been injured. Respondent had no reason to believe that that the patient was suffering from a compartment syndrome on March 2, 1994. Compartment syndrome is a relatively rare occurrence that results in restricted or total loss of blood flow due to swelling within a compartment, which is an enclosed facia. The tibia and fibula are encased in a compartment from the knee to the ankle. Swelling within that compartment produces pressure on the arteries and smaller blood vessels that can restrict or completely block the flow of blood below the area of the swelling. It typically takes several hours or days for a compartment syndrome to manifest itself. On the morning of March 3, 1994, Respondent aligned T. P.'s leg, thereby reducing the fractures, and stabilized it by inserting pins in the leg and applying an external fixater attached above and below the fracture sites. At approximately 10:00 a.m. on March 3, 1994, the patient was moved from the operating room to the recovery room. At the time the patient left the operating room, there were no signs that anything untoward had happened. The recovery room records reflect that at approximately 10:05 a.m., there was no pulse below the fracture site. Respondent observed in the recovery room that the leg below the fracture was ischemic (receiving little or no oxygen). Respondent testified, credibly, that he considered whether the patient was suffering a compartment syndrome, but that he concluded that he probably was not because of the rapid onset of the problem following the reduction and the placing of the fixater, and because the leg remained supple and had not changed from the earlier examination. Respondent immediately ordered an angiogram, the appropriate diagnostic examination, and contacted Dr. Marcos Zequeira, a vascular surgeon on the staff of Palm Springs. Both Respondent and Dr. Zequeira were of the opinion that the patient had suffered a vascular accident and neither one formed the opinion that they were dealing with a compartment syndrome. Dr. Zequeira and Respondent agreed that an angiogram should be performed to diagnose the cause of the loss of blood flow in the leg. Dr. Zequeira advised Respondent that there were no facilities to perform an angiogram at Palm Springs. 1 Dr. Zequeira and Respondent decided to transfer the patient to Dr. Felix Freshwater, a micro-surgeon at Deering Hospital, to perform an angiogram and perform the procedure that would be necessary to resolve the problem. As soon as could be done, Dr. Zequeira contacted Dr. Freshwater, who agreed to accept the patient. Respondent thereafter immediately made the arrangements for an ambulance, which transported the patient to Deering Hospital. Respondent followed the ambulance in his own car and remained with the patient until after Dr. Freshwater performed surgery on the patient. The patient arrived at Deering Hospital at 2:00 p.m. and the angiogram was completed at 3:40 p.m. Anesthesia was started on the patient at 4:37 p.m. and surgery began at 5:30 p.m. The angiogram performed at Deering Hospital revealed that the patient had suffered a type of a compartment syndrome. It was not a typical compartment syndrome and it could not have been accurately diagnosed without the angiogram. Dr. Freshwater testified that his and Dr. Zequeira's presumptive diagnosis prior to the angiogram was that of a direct arterial injury as opposed to a compartment syndrome. Appropriate surgical intervention required an angiogram. The surgical procedure performed by Dr. Freshwater (fibulectomy-fasciotomy) restored the circulation in the patient's leg. Loss of blood flow presents a serious threat to a patient's leg and can result of the loss of the limb. The longer the blood flow is cut off, the more damage to the leg occurs. Damage can begin to occur in as little as two hours after the flow is cut off. Damage to the leg is certain if blood flow is cut off for twelve hours or longer. Here, the patient's circulation in his leg had been significantly restricted or blocked from approximately 10:05 a.m. until the surgical intervention by Dr. Freshwater. Petitioner did not establish that the patient's subsequent problems with his leg were attributable to that fact.2 Petitioner's experts opined that when he first detected that the blood flow in the leg had been compromised, Respondent should have immediately removed the fixater from the patient and, if necessary, displaced the fracture, thereby restoring the flow of blood. These witnesses, both of whom are highly qualified in their fields of practice, testified that Respondent's failure to take prompt action to restore the flow of blood was below the acceptable standard of care. Dr. Freshwater and Dr. Shall were of the opinion that Respondent did not practice below the standard of care. All experts agree that it was appropriate for Respondent to consult with Dr. Zequeira, a vascular surgeon, and to order an angiogram. All experts agree that the restricted or blocked blood flow presented a danger to the patient's leg, and all agreed that the leg would suffer more damage the longer it took to restore appropriate blood flow. Dr. Freshwater and Dr. Shall were of the opinion that removing the fixater and displacing the fractures as suggested by Petitioner's experts without an angiogram would have presented an unwarranted risk to the patient because an appropriate diagnosis had not been made (and could not have been made without an angiogram) and because moving these spear-like fractures could easily have resulted in more damage to the leg, such as cutting or puncturing an artery. The more persuasive evidence established that it was appropriate for the Respondent to transfer the patient to the care of Dr. Freshwater because Dr. Freshwater was imminently qualified to perform the delicate surgery that was thought necessary to restore the blood flow and because Deering Hospital had the facilities to perform the requisite angiogram. All of the treating physicians were aware that time was of the essence and they moved as expeditiously as circumstances and prudence permitted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against the Respondent be dismissed. DONE AND ENTERED this 11th day of February, 1999, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 11th day of February, 1999.
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, John Isaac Delgado (Respondent) has been a physician in the state, holding Florida license number ME 0054871. The Respondent's last address of record is 7820 North Armenia Avenue, Tampa, Florida, 33629. The Respondent has been licensed to practice in Florida since 1989. At about 8:30 p.m. on February 9, 1992, Patient W. S. (Patient) presented to the Emergency Room at St. Joseph's Hospital, Tampa, apparently complaining of right lower quadrant pain. Immediately prior to being seen at the emergency room, the Patient had been playing cards with friends and had apparently fainted. The Patient, a 74 year old obese white male, had a history of diabetes, coronary artery disease and had a previous myocardial infarction. At the emergency room, the Patient was initially examined by John C. Siano, M.D. Dr. Siano ordered chest and abdominal x-rays. The Respondent was the internist on call at the time the Patient was examined in the emergency room. Dr. Siano contacted the Respondent and notified him of the situation. The Respondent examined the Patient at about 10 p.m. The examination was extensively documented. At the time the Respondent initially examined the Patient, the Patient provided an incomplete summary of his symptoms. The Patient had apparently informed emergency room personnel of severe pain; however, this information was not provided to the Respondent. The Respondent was aware only of intermittent abdominal pain. The Patient's emergency room records were missing at the time of the Respondent's examination. The Respondent unsuccessfully attempted to locate the Patient's records during his examination of the patient. Upon examination, the Respondent determined that the Patient's blood pressure was within normal range and was stable. The Patient was alert and oriented. Vital signs were normal. The patient appeared to be in stable condition. While in the emergency room, the Patient had a bowel movement which tested positive for the presence of blood. A nasogastric tube exiting from the Patient indicated "coffee grounds" material. These factors are indicative of a gastrointestinal problem. The presence of blood in the intestinal tract and abdominal pain is indicative of a gastrointestinal disorder. The evidence fails to establish that the patient presented an emergency condition at the time of the Respondent's examination. Back pain is a symptom of an expanding abdominal aortic aneurysm. An expanding aneurysm presses against nerves and muscle in the back and sides of a patient. In this case, the aneurysm was of considerable size; nonetheless, the evidence fails to establish that the Patient informed the Respondent of severe back pain. Severe continuing abdominal pain may be a symptom of a ruptured abdominal aortic aneurysm. The evidence fails to establish that the Patient informed the Respondent of severe continuing abdominal pain. There was no palpable pulsatile mass in the Patient's abdomen which would have been indicative of an aneurysm. There was no "bruit" sound emanating from the patient's abdomen. Such sounds are indicative of an aneurysm. There was no asymmetry of pulses in the Patient's legs which would have been indicative of the aneurysm. Hypotension, such as may result in fainting, can be indicative of an aneurysm. The patient was hypotensive when he arrived at the emergency room; however, treatment with intravenous fluids brought the Patient's pressure back to a normal range within a few minutes, indicating that internal bleeding was not significant. Based on the symptoms described by the patient and on review of the patient's condition, the Respondent's tentative diagnosis was upper gastrointestinal bleeding, likely peptic ulcer disease with bleeding secondary to chronic aspirin usage and colonic polyps. There was also a suggestion of acute diverticulitis with associated bleeding. The Respondent ordered a series of abdominal x-rays be taken. The Respondent ordered appropriate diagnostic studies based on his tentative diagnosis. The tests were scheduled for the morning. The Respondent also requested a surgical consultation, which was also scheduled for the morning. Based on the examination and discussion with Dr. Siano, the Respondent admitted the Patient to a regular floor for further observation. At the time the Patient was admitted, the Respondent had not reviewed the results of the abdominal x-rays. The Respondent did not review the x-rays prior to leaving the hospital that night. The evidence is insufficient to establish that the Respondent's failure to review the x-rays prior to admission or prior to leaving the hospital for the night violated the acceptable standard of care. Based on the patient's condition as expressed to the Respondent and on the results of the examination, the evidence fails to establish that the Respondent should have diagnosed the situation as an aneurysm. The mere existence of an aneurysm is not a surgical emergency. Whether to surgically treat an aneurysm depends on a number of other factors. A ruptured aneurysm is an emergency life threatening condition. Time is critical when responding to a ruptured aneurysm. The evidence is insufficient to establish that the Respondent knew or should have known that the Patient was suffering from a ruptured aneurysm. In the morning of February 10, 1992, a general surgical consultation was done by Frederick Reddy, M.D. Dr. Reddy examined the patient and reviewed the abdominal x-rays which had been taken on the Respondent's orders. According to Dr. Reddy, at the time of his exam the patient complained of intermittent abdominal pain, and said that he had a history of back pain, but did not complain of back pain at that time. Dr. Reddy's review of the x-rays indicated the presence of calcification. While calcification is indicative of an possible aneurysm, the evidence fails to establish that the Patient's aneurysm is clearly indicated by the x-rays. Dr. Reddy saw no indication of rupture, but referred the case to a radiologist and ordered a CT scan on the radiologist's recommendation. The CT scan indicated that an aneurysm had ruptured. The Patient was taken to surgery where G. K. James, M.D. repaired the ruptured aneurysm and performed an aortobifemoral bypass graft. The Patient's condition deteriorated and he expired on February 10, 1992. The evidence fails to establish that the outcome of the case would have been different had the Respondent diagnosed the problem as a ruptured abdominal aortic aneurysm or had the surgical procedure been performed at an earlier time after the Patient's arrival at the hospital emergency room.
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 dismissing the Administrative Complaint filed in this case. DONE and ENTERED this 27th day of February, 1996, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM, Hearing Officer Division of Administrative Hearing The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of February, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1981 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1. Rejected, not supported by cited evidence. Petitioner's exhibit Number 1 identifies the Respondent's address as set forth herein. Rejected. The greater weight of evidence fails to establish that the x-rays revealed the presence of a ruptured aneurysm. The ruptured aneurysm was diagnosed after a CT scan and review by a radiologist. Rejected, subordinate. While the statement that the cited physician always reads his ordered x-rays is correct, the evidence fails to establish that failure to do so is a violation of the acceptable standard of care. Rejected. The cited evidence does not establish that the x-ray "very clearly" suggests the aneurysm. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. No evidence that the Respondent was aware of the statement made by the Patient. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent required an immediate consultation. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent indicated a course of treatment other than as set by the Respondent. Rejected, subordinate. Rejected. Not supported by the greater weight of credible and persuasive evidence. Respondent's Proposed Findings of Fact. The Respondent's proposed findings of fact are set forth in unnumbered paragraphs, many of which fail to contain citation to the record as required by Rule 60Q-2.031(3), Florida Administrative Code. Proposed findings which cite to the record are accepted as modified and incorporated in the Recommended Order, or are otherwise rejected as subordinate or as recitation of testimony. 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, Florida 32399-0792 Steve Rothenburg Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Clifford L. Somers, Esquire 3242 Henderson Boulevard, Suite 301 Tampa, Florida 33609
The Issue The issue in this case is whether Respondent, Cesar Augusto Lara, M.D., should be disciplined on charges alleged in the Administrative Complaint filed by Petitioner, the Department of Health (DOH), in DOH Case No. 96-12965. Essentially, the charges are that Respondent practiced medicine below acceptable standards after receiving a questionable chest X-ray on a patient on November 17, 1994.
Findings Of Fact Respondent is a Florida licensed physician, having been issued license number ME 0060883. He has been licensed to practice medicine in the State of Florida since 1991. Respondent is board certified in family practice. He maintains a private office practice in Clearwater. He is well-respected and has never been disciplined by the Florida Board of Medicine. This case concerns Respondent's care and treatment of patient D.G. After leaving the care of Respondent, D.G. was diagnosed with lung cancer. The patient died of the disease in August 1995, before having given any sworn testimony or statement regarding Respondent's care and treatment. Respondent began providing medical care to D.G. for upper respiratory problems in January 1994. She had a history of smoking and told Respondent that she had just quit. Some time later, D.G. presented to Respondent with complaints of swelling in the left hand and an inability to move her thumb. Respondent attempted conservative treatment of D.G.’s left hand and thumb; but when her condition did not improve, Respondent referred her to an orthopedic surgeon, Dr. Michael Rothberg, on March 31, 1994. Following referral to Dr. Rothberg, Respondent continued to serve as D.G.’s primary care physician, taking care of other problems unrelated to her left hand and thumb. On November 3, 1994, Dr. Rothberg had D.G. return to Respondent to obtain surgical clearance for surgery on her hand to be performed under regional block anesthesia on November 29, 1994. Dr. Rothberg specifically requested that Respondent include the following laboratory (lab) studies as part of the surgical clearance: CBC and SMAC routine blood studies; urinalysis; and an EKG. Respondent saw the patient for surgical clearance on November 14, 1994. Respondent conducted a physical examination and ordered the laboratory studies requested by Dr. Rothberg. In addition, Respondent decided to get a chest X-ray as part of his surgical clearance. Based on his physical examination of the patient, Respondent found D.G. to be generally healthy without any respiratory symptoms or contraindications for surgery. Pending receipt of the lab results, Respondent felt that D.G. could undergo the planned surgery by Dr. Rothberg; he did not anticipate lab results that would contraindicate the planned surgery. Respondent dictated a report to that effect in the patient's presence in the examination room. The typed dictation was initialed by Respondent two days later, on November 16, 1994. Respondent testified that, at the conclusion of the office visit on November 14, 1994, he requested that D.G. return to his office in 4-to-6 weeks for follow-up. Petitioner questioned Respondent's sworn testimony on the ground that there was no documentation in the medical record supporting it. But it was Respondent's routine practice to have patients return to his office following surgery so that he could follow the recovery of his patients from the surgery. In addition, Respondent marked an "encounter form" to indicate his desire for D.G. to return to the office for follow-up in 4-to-6 weeks. An "encounter form" is a common communication tool between a physician and his office staff. It provides a means by which the patient is billed for the services provided. It also provides the staff with direction on scheduling patients for return or follow-up visits. The patient presents the encounter form to Respondent's office staff on the way out of the office. Necessary patient payments are made, and the next appointment is scheduled. The office then utilizes the form to secure third-party payments. Petitioner suggested that the encounter form in evidence as Respondent's Exhibit 2 was fabricated on the ground that Respondent did not produce it until a short time before final hearing. Respondent denied the suggestion, explaining that he did not look for it at first because he did not realize how important it was. Respondent's testimony is accepted, and the suggestion of fabrication is rejected. Should the patient refuse the appointment requested by Respondent on an encounter form, or wish to call back and schedule it later, Respondent's office staff routinely would make a notation on the form indicating that the appointment was not scheduled or that the patient would call to schedule. In this case, no such notations were made on the form. Based on routine office practice, the absence of any such notation would signify, in all probability, that D.G. was given a follow-up appointment in the requested time frame before she left Respondent's office, that the appointment was entered in Respondent's computer, and that D.G. was given a card indicating the date of her appointment. By the time of the hearing, there was no way to verify D.G.'s follow-up appointment using Respondent's office computer. Some time in 1998, Respondent switched his office computer system. The new system does not have appointment information going back to 1994, and the old system with old appointment information was not retained. Two days later, on November 16, 1994, Respondent received an imaging report of D.G.'s chest X-ray. The radiologist reported questionable slight prominence of left hilar region, inferiorly, on the posterior-anterior view. On lateral view, no definitive density could be discerned. The radiologist suggested that comparison with old films would be helpful; if old films were not available, he recommended CT examination. Respondent initialed the radiologist's report the next day, November 17, 1994. Respondent testified that it was his routine practice to initial such a report when he reviewed it. He testified that he decided not to withdraw surgical clearance based on the report. Petitioner questioned Respondent's testimony on the ground that there is no medical record documenting Respondent's decision, other than Respondent's dated initials on the imaging report. But Respondent's testimony in this regard is accepted, and Petitioner's suggestion that Respondent was not even aware of the content of the report is rejected. Respondent's medical record on D.G.'s medical record contains no other information until a pharmacist telephoned Respondent's office on January 18, 1995, to ask Respondent to authorize refilling a prescription for erythromycin. Respondent had his office relay to the pharmacist that Respondent would not authorize refilling the prescription unless Respondent saw the patient in his office. Respondent did not mention the missed appointment or questionable X-ray to the pharmacist, and D.G. never called for an appointment. On or about March 14, 1995, D.G. presented to another physician, Dr. Christopher Purcell, complaining of a five-day cough, pain in the left scapular region, and congestion and wheezing. There was no indication in Dr. Purcell's record that D.G. mentioned the questionable imaging report dated November 16, 1994. (Dr. Purcell did not testify.) On April 11, 1995, Dr. Purcell received D.G.'s medical records from Respondent's office, including the imaging report dated November 16, 1994. Dr. Purcell immediately ordered a repeat X-ray and referred D.G. for a consultation with a specialist on the same day. Not long after, D.G. was diagnosed with lung cancer. She died on August 10, 1995, from squamous cell lung cancer with metastasis to the thoracic spine. Notwithstanding the absence of any medical records between Respondent's dated initials on the imaging report on November 17, 1994, and January 18, 1995, Respondent testified to a clear recollection of discussing the report with D.G. He testified that he told her they would have to follow-up and resolve the questionable findings but that it could wait until follow-up after her planned surgery. Respondent testified that, for reasons unknown to him, D.G. canceled her follow-up appointment, never rescheduled, and never returned. There was no documentary evidence of D.G.'s canceled appointment, but the evidence was that no such evidence would exist except for cancellations or "no-shows" on the day of an appointment, in which case there would be a notation on a daily appointment sheet. For cancellations prior to the day of an appointment, the appointment would be erased from the calendar so the appointment time could be used for another patient. At the time, Respondent had no system in place for contacting patients who canceled an appointment without rescheduling. Now, after commencement of a lawsuit against him on the facts of this case, Respondent has instituted a "911" system of flagging patients whose medical condition requires the rescheduling of canceled or missed appointments. Petitioner contends that the evidence was clear and convincing that Respondent did not advise D.G. of the results of her chest X-ray or any plan for follow-up, notwithstanding Respondent's testimony that he did. Petitioner not only points to the suspicious absence of medical records (in contrast to Respondent's otherwise complete and accurate medical records) but also points out the patient's history of general good compliance with Respondent's orders and her failure to tell either her husband or Dr. Purcell about the questionable imaging report dated November 16, 1994. As for the absence of medical records, it was Respondent's routine practice upon receipt of a questionable X- ray or other lab report to ask for the patient's file and telephone the patient. Then, depending on the nature of the report and the patient involved, Respondent either would discuss the report and a plan for follow-up on the telephone or arrange for an appointment to discuss those matters in person in Respondent's office. If Respondent discussed the matter on the telephone, he normally would document the telephone call and the plan in the patient's medical record. However, it is possible that Respondent made the call to D.G. from outside the office without having her medical record available; it also is possible that he had to leave a message for D.G. and that her medical record was not readily available to him when she returned the call. Either scenario could have led to Respondent's failure to make a record of his telephone call to D.G. Respondent concedes that D.G. was a compliant patient who generally followed his orders and recommendations. She was interested and concerned about health issues affecting her and would not be inclined to ignore medical advice on them. But changes in Respondent's relationship with D.G.'s health care plan--PruCare--could explain why D.G. did not keep her follow-up appointment with Respondent. It was public knowledge that PruCare was terminating its contracts with several area physicians including Respondent, effective January 1, 1995. Respondent gave written notification of these events to his PruCare patients. PruCare also notified its insureds. Both the terminated physicians and PruCare placed advertisements in local newspapers asserting the merits of their positions in the dispute that arose from the termination. Newspaper articles also were published on the issue. It is highly probable that D.G. became aware of the contract termination in one way or another. As a result of the contract termination, PruCare would not cover visits to Respondent after January 1, 1995. Most PruCare patients changed primary care physicians to keep the financial benefit of their PruCare policies. It is possible that D.G.'s follow-up appointment was scheduled for just after the first of the year and that she called to cancel, anticipating following up with a new PruCare-approved primary care physician. Even if the follow-up appointment was scheduled for December 1994, it is quite conceivable that D.G. canceled it in the same anticipation. Normally, D.G. would discuss her health concerns with her husband. But her husband also testified that she did not discuss everything with him. Specifically, he had no knowledge that she was having a chest X-ray taken prior to her hand surgery. Nor did he know the specifics of any of the lab studies done for Respondent's clearance for surgery. It is more difficult to explain the patient's apparent failure to mention the questionable imaging report to Dr. Purcell on March 14, 1995 (based on the absence of any medical record documenting such a disclosure to him.) Assuming completeness of Dr. Purcell's medical records, it could well be that Respondent did not impress on D.G. the possible significance of the findings during his telephone conversation with her after review of the imaging report. He might not have seen the need to do so prior to the follow-up appointment he was anticipating. He also might not have wanted to so as not to unnecessarily complicate the impending hand surgery by making the patient overly anxious about the imaging report and what it could signify. Taking all of the evidence into consideration, it is found that Petitioner did not prove by clear and convincing evidence Respondent's alleged failure to advise D.G. of the results of her chest X-ray or any plan for follow-up. Besides Respondent, three physicians testified as experts in this case. All agree that the "level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances" (the "standard of care") required Respondent to notify the patient to discuss the report and a plan of follow-up, which could include: physical examination; review of older X- rays (to determine if there was a change between X-rays); a repeat X-ray; a CT study (for a clearer image than an X-ray); and referral to a specialist. The disagreements among the experts centered on the urgency of follow-up and the assumed facts. Respondent's two experts accepted the veracity of Respondent's testimony that Respondent discussed with the patient the imaging report and his plan for follow-up at the appointment scheduled for follow-up for the hand surgery. Petitioner's expert assumed the contrary. Petitioner's expert testified that it was incumbent on Respondent to follow-up within 24-48 hours. But it was not clear from his testimony if "follow-up" in this context meant anything other than notification to the patient and discussion of a plan for timely follow-up. If so, Petitioner's expert was at odds with the other experts, all of whom clearly testified to their opinions that the other means of follow-up could be accomplished within anywhere from two weeks to two months. (As for physical examination, Respondent already had examined the patient on November 14, 1994, and there were no symptoms. As for review of older X-rays, the only previous X-ray was from 1989, and Respondent testified to his opinion that simply reviewing an X-ray that old would not meet the "standard of care.") Respondent and his experts placed responsibility on the patient to follow her doctor's recommendations. They did not think the "standard of care" required Respondent to contact D.G. to remind her, much less require her, to reschedule her appointment. In all probability, D.G. would have rescheduled but for PruCare's cancellation of its contract with Respondent. Through a combination of circumstances for which they did not think Respondent should be held responsible, the patient did not reschedule her appointment and was "lost to follow-up" by Respondent. Based on the pertinent factual findings and the expert testimony, Petitioner did not prove by clear and convincing evidence that Respondent practiced medicine below the "standard of care." Petitioner also suggested that Respondent was at fault for not directing D.G. to a particular primary care physician for medical care after January 1, 1995. But Respondent and his staff testified that PruCare did not make Respondent aware of his patients' options for primary care after the contract termination. There was no evidence to dispute their testimony to that effect. Nor was there any evidence that the "standard of care" required Respondent to direct D.G. to a particular primary care physician for medical care after January 1, 1995. Finally, Petitioner suggested that Respondent had an obligation to follow-up on the missed appointment when the pharmacist telephoned on January 18, 1995. Petitioner's argument would have been stronger had the patient telephoned instead of the pharmacist. As it was, the evidence was not clear and convincing that a telephone call from a pharmacist should have triggered the realization that D.G. had missed her follow-up appointment. In addition, there was no evidence that the "standard of care" required Respondent to follow-up on the missed appointment at that point. Besides, it would have been reasonable for Respondent to assume at that point that D.G. probably would not return to him but would see a new primary care physician contracted to PruCare under the patient's health care plan. Clearly, early detection and treatment of cancer is important. But, while not particularly relevant to the question of whether Respondent practiced within the "standard of care," it is noted that all of the physicians testifying as experts agreed that the outcome probably would not have been different had D.G.'s cancer been diagnosed in November 1994. Unfortunately, lung cancer is difficult to detect; when detected, it usually is beyond cure, and death usually follows relatively soon thereafter.
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 Respondent not guilty. DONE AND ENTERED this 17th day of July, 2000, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 17th day of July, 2000. COPIES FURNISHED: Britt Thomas, Esquire Laudelina McDonald, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Jon M. Pellett, Esquire Freeman, Hunter & Maloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0750
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
