The Issue The issue is whether Respondent's license as a medical doctor should be disciplined for the reasons given in the Administrative Complaint filed on October 25, 2000.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background At all times material hereto, Respondent, David Lowell Williams (Respondent or Dr. Williams), was a licensed medical doctor having been issued license number ME 0035686 by Petitioner, Department of Health, Board of Medicine (Board). The Board is charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent is board-certified in cardiovascular disease and internal medicine and has practiced his specialty in Ormond Beach, Florida, since 1983. In 1990, Respondent accepted a position as a cardiologist with Florida Health Care Plan, Inc. Except for the charges raised in this proceeding, there is no evidence that Respondent has ever been involved in a prior disciplinary action. Based on a complaint filed with the Board by an attorney representing the family of a former patient, S.T., on October 25, 2000, the Department of Health, acting on behalf of the Board, filed an Administrative Complaint against Respondent generally alleging that in April 1995 he had failed to practice medicine with the level of skill and care required of a reasonably prudent physician, and that he failed to keep written medical records justifying the course of treatment of S.T. Respondent has denied the charges and contends that he practiced medicine within the standard of care and that the documentation related to the patient justified the course of treatment. In determining whether a deviation from the appropriate standard has occurred, the undersigned has considered the conflicting testimony presented by the witnesses and has accepted the more credible evidence, as reflected in the findings below. In doing so, the undersigned has discounted Petitioner's contention that Respondent's expert, Dr. Henderson, is a close friend of Respondent and therefore his testimony is clearly biased. Although the two once practiced together for a few years in the 1980's, Dr. Henderson acknowledged that they "don't get along very well right now." The treatment of the patient Over a period of years, S.T. was treated by several doctors, including Respondent, who participated in the Florida Health Care Plan, Inc. network. The medical records for that treatment have been received in evidence as Joint Exhibit No. Because they are not in chronological order, contain matters relating to treatment by physicians other than Respondent, and include some partially illigible pages, the records are somewhat difficult for the reader to navigate. They do show, however, that S.T. occasionally cancelled appointments, would not always accept his doctor's advice, sometimes refused to take prescribed medications, and was perhaps not totally candid at all times with the treating physician regarding his symptoms. The records reflect that Respondent first began treating S.T. on March 29, 1989, on referral from his primary care doctor, Dr. Moussly, due to complaints of "burning in chest with exercise." S.T., then a sixty-year-old male, underwent a stress test on the treadmill which was terminated after three and one-half minutes due to fatigue and shortness of breath. The test revealed "significant ST segment depression" and was consistent with ischemia (inadequate blood flow to the heart). Respondent prescribed Lopressor (a beta- blocking agent used in the treatment of hypertension and angina) and a Nitro-patch (transdermal nitroglycerin delivery system). Dr. Williams also recommended that the patient have a cardiac catherization. Even though the records show that the patient was "reluctant to do this at this point in time," they indicate that a coronary angiogram was performed by Respondent on April 26, 1989, and that "a high-grade stenosis of approximately 90 [percent] . . . with deeply ulcerated plaque" was exhibited in the left anterior descending artery. S.T. was again referred by Dr. Moussly to Respondent on March 7, 1990, "on an urgent basis." However, S.T. cancelled his appointment and accepted another appointment on April 4, 1990. Despite the urgency of the referral, S.T. reported to Dr. Williams that he was doing well with no symptoms since his last visit one year earlier. His records reflect that his blood pressure was 136/86, his weight 258, his pulse was 60 and regular, his lungs were clear, and a cardiovascular examination was unremarkable. Dr. Williams concluded that S.T. was stable at that time with minimal chest discomfort, and he recommended that S.T. undergo a routine treadmill exercise test to further evaluate his coronary heart disease. A stress test was performed on May 11, 1990, but it was terminated after three minutes due to shortness of breath. Another stress test was conducted on July 5, 1990, the results of which were "significant for ischemia." Although a cardiac catherization was recommended, "[t]he patient again refuses at this point in time." On May 1, 1991, S.T. was again seen by Respondent (after cancelling an earlier appointment) at which time he indicated he was feeling well and was essentially asymptomatic. He specifically denied having any shortness of breath, light-headedness, dizziness, or chest pain, and he reported that he had skipped taking his prescribed Cardizem on numerous occasions without undergoing any significant change in his symptoms. On that date, his blood pressure was 150/90, his weight 259, his lungs were clear, and the cardiovascular examination revealed no murmur. Dr. Williams concluded that the patient "seems to be stable at this point in time," and allowed S.T. to discontinue Cardizem as a therapeutic trial, and if he had no further symptoms, he would continue on Lopressor only. Otherwise, he would need to start up on that medication again. Finally, Dr. Williams offered S.T. the opportunity to participate in a beta blocker angina trial for which he would be evaluated the following week. The patient apparently declined this offer. The patient did not return to Respondent's office until December 21, 1994, or more than three years later, after he was given a "[r]outine referral for a stress test" by Dr. Moussly. S.T. had seen Dr. Moussly on a "routine followup" on December 1, 1994, at which time he denied having chest pain or shortness of breath. On his visit with Respondent, S.T. underwent another treadmill test that was terminated after two minutes due to the development of ST- segment depression. S.T. also experienced tightness in his chest. The treadmill tests were positive for ischemia "at low exercise tolerance." Based on the above results, S.T. agreed to undergo cardiac catherization. On December 28, 1994, Respondent performed the cardiac catherization on S.T., which revealed that the main coronary artery was very short, but was essentially normal. The left anterior descending artery (one of the three main arteries to the heart) exhibited a proximal 90 percent stenosis (stricture of a canal or narrowing of a cardiac valve). A second 75 percent stenosis was present in the distal portion of the artery. No other significant lesions were noted. The left circumflex artery was a large and dominant system. A stenosis in the distal portion of the parent circumflex of approximately 30 percent was present with no other significant lesions noted. The right coronary artery was a nondominant artery with no significant lesions noted. Based upon the results of the cardiac catherization, Dr. Williams concluded that P.T. demonstrated mild coronary artery disease in the left circumflex artery and "rather severe disease" in the left anterior descending artery. Respondent advised S.T. that he was a candidate for angioplasty (reconstitution or recanalization of a blood vessel) of the left anterior descending artery. On January 4, 1995, Respondent performed the angioplasty of S.T.'s left anterior descending artery, which contained two lesions. The proximal lesion was reduced from approximately 95 percent stenosis to around 10 percent, and the distal lesion was likewise reduced from approximately 75 percent stenosis to around 10 percent. On February 8, 1995, S.T. made a follow-up visit to Respondent's office. According to the patient notes, S.T.'s vital signs were normal, and he stated that he was "doing very well." Respondent's plan of treatment was to have him follow- up on an as-needed basis. In addition, Respondent discussed the "signs and symptoms of recurrence of chest discomfort" and the importance of stopping smoking as well as having good dietary practice and daily exercise. On March 7, 1995, Dr. Moussly again referred S.T. to Dr. Williams for a stress test due to the patient's "having very non[-]specific chest discomfort; non[-]exertional, non[-] radiating [pain that was] apparently . . . different than the pain he had prior to his angioplasty." Dr. Moussly also noted in his records that even though the patient had elevated cholesterol, he refused to take Pravachol, which had been prescribed by Dr. Moussly on December 1, 1994. Pursuant to the referral, on March 15, 1995, S.T. made a follow-up visit to Respondent complaining of "chest discomfort." He underwent another treadmill test which was terminated after three minutes due to chest discomfort and ST- segment depression. The test was positive for ischemia, which meant that restenosis of an artery had likely occurred. Respondent recommended repeat cardiac catheterization and angioplasty. Given S.T.'s age, progression of disease, and risk factors, which included "virtually every one known to man," restenosis was not particularly surprising since Respondent's expert established that "the restenosis rate for this [type of] patient was probably in excess of 50 percent." On March 17, 1995, Respondent performed a second angioplasty of S.T.'s left anterior descending artery and reduced the stenosis from 75 percent to 10 percent in both the proximal and distal lesions. There were no complications from this procedure, which S.T. tolerated well. On April 3, 1995, S.T. visited Respondent's office for a follow-up at which time he complained of chest discomfort. At that time, S.T. was "very vague about his discomfort" in terms of how often it occurred, how long it lasted, whether there were accompanying symptoms present, and whether the Nitroglycerin provided relief. S.T. did acknowledge, however, that the discomfort was "very infrequent." The records for that visit read as follows: Mr. T. since his last visit is having some chest discomfort, although, it has been better. He has taken some sublingual Nitroglycerin on a number of occasions, but is unable to recall exactly how often. His episodes are not exertionally related, different in type and severity than prior to his angioplasty. I feel he may be having coronary spasm, although, I cannot totally rule out restenosis. In any event, his symptoms are relatively mild. I have asked him to continue as we're doing. He wil [sic] return in two more weeks for follow-up examination. I have asked him to call should he get worse and he has, otherwise, been asked to keep a diary so that we can more objectively quantify his Nitroglycerin usage. Although S.T.'s vital signs are not recorded in the above note, Dr. Williams performed a physical examination of the patient that day, and he recorded the vital signs on a separate office record entitled "Vital Sign Sheet." He also maintained a separate patient medication chart, which reflected the various medications taken by all his patients; however, due to its age, that chart has been purged in the normal course of business. A stress test was not ordered by Respondent since he considered the patient's chest discomfort to be "very mild," and the patient described the pain as "completely different" than his previous angina. Also, the pain was not exertionally related, and restenosis was unlikely "at this early date following an angioplasty." Dr. Williams concluded that more than likely the pain was a coronary spasm (a muscular contraction of the wall of the artery), which typically occurs up to 30 to 60 days after the procedure, and he would wait "to see if [the symptoms are going] to go away . . . [w]hich they frequently do after an angioplasty." Finally, Respondent noted that the cardinal indicators of ischemic heart disease (a blockage) were not present - - exertional pain, relief from Nitroglycerin, and a similarity with pain experienced before the angioplasty was performed. He accordingly advised S.T. to continue his present course of treatment and to follow-up in two weeks, or if his condition worsened, to return sooner or go to an emergency room. On Friday, April 7, 1995, S.T. went to the Halifax Hospital Emergency Room in Daytona Beach, Florida, complaining of chest pressure, accompanied by an episode of dizziness, weakness, diaphoresis, and nausea. He also advised that he had been taking several Nitroglycerines on a regular basis. Respondent was not present at the facility, and was not the on-call cardiologist on this date. S.T. was seen by Dr. David E. Stibbins, who observed that S.T. was bradycardic and had low blood pressure. Like the information given to Dr. Williams on April 3, here the patient gave vague information regarding his chest discomfort. The records suggest that Dr. Stibbins opined that the patient's discomfort was not cardiac related and was probably due to anxiety. A cardiac consultation was requested, but not conducted, and S.T. was kept in the hospital overnight for observation. Around 1:15 a.m., S.T. reported a few "twinges" in his chest to the nurse, but he told her the pain was not serious enough to wake up his doctor. After denying that he had experienced any chest pain other than the few twinges described above, on the afternoon of April 8, 1995, S.T. was discharged from the hospital in stable condition (without ever being seen by a cardiologist) and advised to follow-up with Respondent in two days (the following Monday). On Sunday, April 9, 1995, the patient suffered a cardiac event and expired. The cause of death on his certificate of death is probable sudden death as a result of coronary artery disease, but neither expert in this case could give a precise reason for S.T.'s demise. The standard of care In the aftermath of an angioplasty, a variety of things can occur causing chest discomfort in the patient. While the beneficial effects of an angioplasty "can last . . . [up] to 20 years," three to five percent of patients experience an acute closure within a matter of minutes or hours, which is the sudden and complete obstruction of the artery. Because of this risk, after a procedure is performed, patients are kept in the hospital at least over night for observation. An acute closure often occurs in patients with a 70 to 80 percent narrowing of the artery. During the first few weeks after a procedure, acute thrombosis to the vessel at the site of the injury sometimes occurs, but a patient with that condition would experience "intense discomfort that's exactly the same as the patient's pre-intervention discomfort." Without such symptoms, that diagnosis would be "down [on] the list of considerations" by the treating physician. Between six and eight weeks and four months after the procedure, up to a third of balloon angioplasty patients experience a subacute closure (or restenosis) of the artery. Typically, these patients return to the physician's office with clinical symptoms of angina chest pain (similar to that experienced before the procedure) and require a repeat procedure. If restenosis has occurred, the patient is at risk for additional cardiac complications, such as myocardial infarction (heart attack). In some cases, within 30 to 60 days after a procedure, a patient will experience a "different type of sensation" in the chest due to the mechanical stretching of the vessel wall during the procedure. Other patients experience an artery spasm (cramping of the vessel wall), which occurs when the muscle cells go into spasm and constrict the artery. In both of these situations, the discomfort is dissimilar to that experienced before the procedure. Given the foregoing, if a patient presents himself to the doctor within a matter of weeks after an angioplasty with vague, non-ischemic related chest discomfort, it is not a deviation from the standard of care for the physician to choose a course of treatment consisting of "medical management" of the patient, that is, the close monitoring of the patient in the following days and weeks, and treating the patient with beta blockers, nitrates, and aspirin to ameliorate his symptoms. Conversely, if a patient presents himself to the physician with chest discomfort which is ischemic in nature, the ordering of further tests, including an exercise EKG, would be appropriate, with possible referral to a hospital for another cardiac catherization. Other considerations in determining the appropriate course of treatment of a patient include the cardiologist's familiarity with the patient's prior symptoms and history and the symptoms presented at the current time. In addition, the physician must rely upon his experience, knowledge, and education in the field. Taking into account all of these circumstances and considerations, the more convincing evidence establishes that Respondent did not deviate from the standard of care. c. The adequacy of the patient's records The Board has also alleged that Respondent failed to keep adequate medical records on the April 3, 1995, office visit in that he failed to document a physical examination or the results of any ancillary tests, and that the records as a whole fail to justify the course of treatment of the patient. The criticisms of Dr. Williams are based upon the testimony of the Board's expert, Dr. Dormois, who presented deposition testimony in this matter. In his deposition, however, Dr. Dormois withdrew his earlier criticisms of the records, and he indicated that the records provided by Dr. Williams "are generally adequate." He also concluded that this case "is not an issue of a medical record deficiency," but rather is "a deficiency of [a] failure to make clinical decisions." When these admissions are coupled with the testimony of Dr. Henderson, who concluded that the records were adequate, it is found that the Respondent kept written medical records justifying the course of treatment of the patient.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing, with prejudice, the Administrative Complaint. DONE AND ENTERED this 30th day of August, 2001, in Tallahassee, Leon County, Florida. ___________________________________ DONALD R. ALEXANDER 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 30th day of August, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration Post Office Box 4229 Tallahassee, Florida 32317-4229 Michael R. D'Lugo, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 390 North Orange Avenue Orlando, Florida 32802-1646 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues in this case for determination are whether Respondent Samuel Cox, M.D., committed the violations of Chapter 458, Florida Statutes, as alleged in an Administrative Complaint filed by the Department of Health on November 18, 2006; and, if so, what disciplinary action should be taken against his license to practice medicine in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Samuel Cox, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 77851 on April 22, 1999. Dr. Cox's mailing address of record at all times relevant to this matter is 2438 East Commercial Boulevard, Fort Lauderdale, Florida 33308. Dr. Cox is a board-certified general surgeon who has specialized his practice to bariatric surgery. He has performed bariatric surgery since 1985, performing approximately 3,000 such surgeries since that time. Dr. Cox has performed approximately 214 Roux-en Y procedures in Florida. No evidence that Dr. Cox has previously been the subject of a license disciplinary proceeding was offered. Bariatric Surgery. Bariatric surgery, also known as gastro-bypass surgery, is a type of surgery performed on morbidly obese patients to assist them in losing weight. In order to be found to be morbidly obese and, therefore, to be considered a candidate for the procedure, a patient must be found to have a Body Mass Index greater than 40. Body Mass Index is a measure of body fat based on height and weight (weight in kilograms divided by the square of height in meters). For example, a six-foot-tall individual weighing 296 pounds would have a Body Mass Index of 40.1. See http://www.nhlbisupport.com/bmi/. A patient with a Body Mass Index of 35 may also be considered a candidate for the surgery if they present with certain comorbidities associated with obesity. Comorbidities are physical problems associated with obesity and include diabetes, lung problems, heart problems, and high blood pressure. The more comorbidities a patient has, the higher the risk is to that patient from bariatric surgery. While there is more than one type of bariatric surgery, at issue in this case is a procedure known as Roux-en-Y gastric- bypass surgery (hereinafter referred to as "RNY Surgery"). RNY Surgery is a surgical method of creating a reduced-sized stomach. This reduced-sized stomach is created by removing a small portion of the stomach, where the esophagus (which brings food from the mouth to the stomach) attaches to the stomach, from the larger remaining portion of the stomach. The small portion of the stomach attached to the esophagus is then formed into a pouch, creating a much smaller stomach. The remaining larger portion of the stomach is completely by-passed. Often a device called a silastic ring is used at the bottom of the newly created stomach to help the pouch maintain the desired size and prevent it from stretching into a larger pouch. A portion of the small intestine is attached to the bottom of the newly created stomach. Approximately 150 centimeters down the small intestine, the excluded or removed portion of the stomach, the liver, and the pancreas are connected back to the intestine. This allows digestion of food to continue, but reduces the amount of digestion that previously occurred in the 150 centimeters of the intestine which are bypassed. RNY Surgery allows a patient to lose weight in two ways: first, by limiting the amount of food the patient can eat; and secondly, by reducing the absorption of nutrients by bypassing part of the intestine. The most common and serious complication of RNY Surgery is a leak at the gastrojejunal anastomosis, or the point where the newly created stomach pouch (the gastro) is connected to the intestine (the jejunal)(a gastrojejunal anastomosis leak will hereinafter be referred to simply as a "Leak"). This complication may be evidenced by several symptoms exhibited by a patient. Surgeons performing bariatric surgery must look for these symptoms. The typical symptoms of a Leak include left shoulder pain (caused by pooling of the leakage under the diaphragm which causes irritation which manifests as left shoulder pain), decreased urine output, fever, shortness of breath, and high heart rate. Some manifestations of a Leak, such as atrial fibrillation, are indirect signs of a Leak in that they are associated with the stress on the body caused by the Leak. Dr. Cox's Treatment of Patient W.T. Patient W.T. presented to Dr. Cox for bariatric surgery. W.T., a male, was 47 years of age at the time and was morbidly obese. W.T. weighed 458 pounds and had a Body Mass Index of Because his Body Mass Index exceeded 50, he was considered "super" morbidly obese. He also had the following comorbidities: high blood pressure, sleep apnea, congestive heart failure, thrombophlebitis, pulmonary eboli, diabetes, and gatroesophageal reflux disease. There is no dispute that W.T. was an appropriate candidate for bariatric surgery. W.T. underwent RNY Surgery on August 31, 2005. During the surgery, Dr. Cox experienced difficulty seeing, due to the size of W.T.'s liver, the staples which he used to connect the intestine to the bottom of the newly formed stomach. Instead of confirming the placement of the staples, he was required to assess the staples with his fingers. This should have made him more sensitive to the possibility of a Leak. Before ending the surgery, Dr. Cox performed a test called a methylene blue test. To perform this test, an anesthesiologist puts medicine down a tube which passes through the patient's nose and into the new stomach. The physician then looks for any sign of a leak where the physician has sewn or stapled the small intestine to the stomach. With W.T., the methylene blue test did not disclose any leaks. The day after W.T.'s bariatric surgery, September 1, 2005, W.T. began to complain of pain in his left shoulder which is an important symptom of a Leak. W.T. also experienced decreased urine output during the night (he had, however, "responded well to fluid increases and diuretics"), and a low- grade fever, which are also indicators of a Leak. Although pain is a normal response to any operation, pain in the shoulder for the type of non-laparoscropic bariatric surgery performed by Dr. Cox should have made Dr. Cox more concerned than he apparently was as to the cause. The normal pain response to the type of operation Dr. Cox performed would be expected where the incision was made, but not in the shoulder. Dr. Cox treated W.T.'s shoulder pain with narcotic analgesia by a patient-controlled analgesia pump. He treated the decreased urine output with increased fluids and a diuretic (Mannitol). The fever was treated with Tylenol. Although the left shoulder pain, decrease in urine output, and low-grade fever could have been indicative of a Leak, Dr. Cox made no note in the patient records that he had considered the possibility that W.T. had a Leak, prematurely ruling out the possibility of a Leak. Dr. Cox suggested that the left shoulder pain was related to a diaphragmatic irritation caused by the use of surgical instruments on the diaphragm and that the urine output decline could have been attributable to the impact on W.T.'s kidneys by his diabetes. While these might have been appropriate considerations at the time, Dr. Cox could have not known for sure what was causing W.T.'s symptoms and, therefore, should have considered all the possible causes of these symptoms, especially the possibility of a Leak. On the second post-operative day, September 2, 2005, W.T. exhibited an abnormal heart rhythm, called atrial fibrillation. With a normal heart rhythm, the atrial (the first two of the four heart chambers) contracts, followed by contraction of the ventricles (the other two heart chambers). Atrial fibrillation is an abnormal heart rhythm characterized by a failure of the atria to completely contract. The fact that W.T., who had no prior history of atrial fibrillation, was evidencing atrial fibrillation on post-operative day two should have raised a concern about what was happening to W.T., including, but not limited to, the possibility of a Leak. W.T. was also experiencing an abnormally high heart rate of 148, which could have also been indicative of a Leak. Dr. Cox continued to treat W.T.'s shoulder pain with narcotic analgesia and the decreased urine output with increased fluids and Mannitol. He treated the elevated heart rate with Cardizem, a medicine used to slow the heart. W.T.'s shoulder pain appeared to decrease, which was to be expected given the course of treatment ordered by Dr. Cox. Dr. Cox had not, however, appropriately determined the cause of the pain. Again, nothing in Dr. Cox's medical records indicates that he considered the possibility that W.T.'s various symptoms might be indicative of a Leak. Nor did he take any action, such as an upper gastrointestinal test, to rule out the possibility of a Leak. To perform a gastrointestinal test, a patient drinks a water-soluble contrast called Gastrografin and a radiologists takes serial pictures of the patient, which show the contrast as it moves down the esophagus and then crosses through the anastomosis of the pouch and intestine. From these pictures, it can be determined whether the anastomosis is open and functioning properly and whether any of the contrast leaks outside of the new stomach-intestine path. The test is not fool-proof, but it is an appropriate diagnostic tool for Leaks. Dr. Cox suggests that the atrial fibrillation and high heart rate could have simply been a recognized complication of any stress W.T., with his borderline cardiac status, was experiencing. Again, while these might have been appropriate considerations at the time, Dr. Cox could have not known for sure what was causing W.T.'s symptoms and, therefore, should have considered all the possible causes of these symptoms, especially the possibility of a Leak. On the third post-operative day, September 3, 2005, air and serosanguinous fluid were observed seeping from W.T.'s abdominal incision. The existence of air may be evidence of a Leak. Although some air gets into the abdominal cavity during surgery, it is usually absorbed by the body very, very quickly. Air coming from an incision on post-operative day three suggests a hole in the intestine. Dr. Cox responded to the finding of air coming from the abdominal incision by ordering a methylene blue swallow, where W.T. swallowed a small amount of blue dye. Blue dye was then seen either coming out of the incision or drains placed in W.T.'s abdomen. Either way, the test was "positive" indicating a leak in W.T.'s intestine. Dr. Cox correctly took W.T. back into surgery. He discovered and corrected a Leak which had been caused by failure of the staples used in W.T.'s surgery. Although much was made as to when the staples failed, that evidence was not conclusive nor is it necessary to resolve the dispute. Whether the staples failed immediately after surgery or at some later time does not excuse Dr. Cox's failure to appropriately react to signs exhibited by W.T. which could have indicated that W.T. had a Leak. This case does not turn on whether a Leak actually existed. It turns on whether Dr. Cox appropriately considered the possibility of a Leak and took the steps medically necessary. With W.T., he did not. Dr. Cox's error was not in failing to find the Leak earlier; it was in failing to properly consider the possibility of a Leak when W.T. exhibited signs that should have prevented Dr. Cox from, with reasonable medical certainty, ruling out the possibility that a Leak was present. For this reason, the fact that a Leak was ultimately found is of little importance in deciding whether the charges leveled against him in the Administrative Complaint are accurate. Even if no Leak had ultimately been found, Dr. Cox's failure to properly respond to the potential of a Leak evidenced by W.T.'s symptoms was inconsistent with the standard of care. Dr. Cox's Treatment of Patient J.L. Patient J.L. presented to Dr. Cox for bariatric surgery. J.L., a male, was 35 years of age at the time and was morbidly obese. J.L. weighed 417 pounds and had a Body Mass Index of Because his Body Mass Index exceeded 50, he was considered "super" morbidly obese. He also had the following comorbidities: high cholesterol, stress incontinence, depression, anxiety, high blood pressure, gastroesophageal reflux disease, and shortness of breath on exertion associated with asthma. There is no dispute that J.L. was an appropriate candidate for bariatric surgery. J.L. underwent RNY Surgery on August 4, 2005. Dr. Cox also removed J.L.'s gallbladder. Before ending the surgery, Dr. Cox performed a methylene blue test. The methylene blue test performed on J.L. did not disclose any leaks. On the first post-operative day, August 4, 2005, J.L.'s heart rate was as high as 155 (anything over 120 is problematic), was experiencing decreased oxygen saturation of 89 percent (95 percent to 98 percent are considered normal saturation levels), had increased BUN and creatinine levels, and his urine output was borderline low. The increased BUN and creatinine, indicative of a problem with the kidneys, were are not being perfused well. J.L. was also complaining of right shoulder pain. Dr. Cox's note concerning the right shoulder pain specifically notes that it was not the "left" shoulder, which suggests that Dr. Cox was aware of the significance of left shoulder pain. J.L.'s high heart rate and low oxygen saturation level were considered significant enough to return him to the intensive care unit. On the second post-operative day, August 5, 2005, J.L.'s BUN and creatinine levels rose higher. That evening J.L. had a high heart rate. His urine output level, which Dr. Cox had treated with a diuretic and increased fluids, had improved. J.L. also became agitated and restless. He began to constantly request water. Dr. Cox eventually ordered, however, that J.L. not be given water. Dr. Cox failed to note in his records that he considered the possibility that J.L. had a Leak. Instead, Dr. Cox focused on the possibility that J.L. was suffering from rhabdomyolysis, a malfunction of the kidneys caused by the breakdown, as a result of surgery, of muscle tissue into cells too large in size for the kidneys to process. Dr. Cox ordered a CK test which found elevated creatine phosphor kinase or CPK, a marker of muscle death. Dr. Cox then consulted with a nephrologists. While the symptoms evidenced by J.L. could have very well been a result of rhadbodmyolysis, they also could have been symptomatic of a Leak. Dr. Cox did not have adequate information on August 5, 2005, to conclusively find that J.L. was suffering from rhadbodmyolysis and, more importantly, not from a Leak. As of the second post-operative day, J.L. was exhibiting a high heart rate, low urine output, pain in his right shoulder, a worsening oxygen saturation level and hunger for air, and a changed mental status (anxiety and combativeness). Due to these symptoms, Dr. Cox should have considered the possibility of a Leak, rather than merely concluding that J.L. was suffering from rhabdomyolysis and treating J.L.'s individual symptoms. On the third post-operative day, August 6, 2005, J.L.'s condition worsened. His agitation and combativeness due to his thirst and air hunger worsened. J.L. was treated with Haldol, a psychiatric medication. Dr. Cox continued to suspect rhadbdomyolysis and to ignore the possibility of a Leak. On the fourth post-operative day, August 7, 2005, at approximately 15:30, pink-tinged fluid was seen draining from J.L.'s incision. A pulmonologist consulting on J.L.'s case was the first to suggest the possibility of a Leak, questioning whether the entire clinical picture pointed to intra-abdominal sepsis due to a Leak. It was not until the drainage from J.L.'s incision that Dr. Cox first considered the possibility of a Leak. Even then, Dr. Cox did not return J.L. to surgery until August 7, 2005, where a Leak was found and repaired. Dr. Cox's error in his treatment of J.L., like his error in his treatment of W.T., was not in failing to find the Leak earlier, but in failing to properly consider the possibility of a Leak when J.L. exhibited signs which should have prevented Dr. Cox from, with reasonable medical certainty, ruling out the possibility that a Leak was present. For this reason, the fact that a Leak was ultimately found is of little importance in deciding whether the charges leveled against him in the Administrative Complaint are accurate. Even if no Leak had ultimately been found, Dr. Cox's failure to properly respond to the potential of a Leak, evidenced by J.L.'s symptoms, was inconsistent with the standard of care. Dr. Cox's explanation at hearing as to why he waited from August 5, 2005, when it was apparent that J.L. had a Leak, until August 7, 2005, to repair the Leak, is not contained in Dr. Cox's medical records. The Standard of Care. The Department's expert, Christian Birkedal, M.D., credibly opined that Dr. Cox failed to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure in violation of Section 458.331(1)(t), Florida Statutes (hereinafter referred to as the "Standard of Care"), in his treatment of W.T. and J.L. In particular, it was Dr. Birkedal's opinion that Dr. Cox violated the Standard of Care as to W.T. by failing to recognize W.T.'s signs and symptoms of a Leak and by failing to perform a post-operative upper gastrointestinal test on W.T. once he evidenced those signs. Dr. Birkedal's opinion is credited and accepted. As to J.L., Dr. Birkedal's opinion that Dr. Cox violated the Standard of Care by failing to recognize the signs and symptoms of a Leak for two days post-operatively is credited and accepted. The opinions to the contrary offered by Dr. Cox and his witnesses as to W.T. and J.L. are rejected as not convincing and as not addressing the issue precisely enough. The opinions offered by Dr. Cox and his witnesses with regard to both patients were essentially that the various symptoms pointed to by Dr. Birkedal were not "evidence" of a Leak. Those opinions do not specifically address the issue in this case. Dr. Cox and his witnesses based their opinions on whether Dr. Cox should have "known" there was a Leak at the times in issue. That is not the charge of the Administrative Complaint or the basis for Dr. Birkedal's opinion. The question was, not whether Dr. Cox should have known there was a Leak, but whether he should have considered a Leak as a possible cause for the symptoms exhibited by W.T. and J.L. Additionally, and finally, Dr. Birkedal based his opinions, not by looking at the record as a whole, as did Dr. Cox and his experts, but by looking at only those records in existence at the times relevant to this matter. In this way, Dr. Birkedal limited himself to a consideration of what Dr. Cox knew about his patients at the times relevant in the Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Samuel Cox, M.D., has violated Section 458.331(1)(m) and (t), Florida Statutes, as alleged in Counts I, II, and III of the Administrative Complaint; issuing a reprimand; placing his license on probation for two years, with terms to be established by the Board; and imposing a fine of $15,000. DONE AND ENTERED this 19th day of June, 2007, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 19th day of June, 2007. COPIES FURNISHED: Patricia Nelson, Esquire Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3250 Jonathon P. Lynn, Esquire Marci Strauss, Esquire Stephens, Lynn, Klein 301 East Las Olas Boulevard, Suite 800 Fort Lauderdale, Florida 33301 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
The Issue Should discipline be imposed against Respondent based upon the allegation that she failed to meet minimal standards of acceptable and prevailing nursing practice in violation of Section 464.018(1)(n), Florida Statutes (2002)?
Findings Of Fact STIPULATED FACTS: Petitioner is the state department charged with regulating the practice of nursing pursuant to Section 20.43, Florida Statutes, Chapter 456, Florida Statutes, and Chapter 464, Florida Statutes. At all times material to the Complaint, Respondent was licensed to practice as a certified registered nurse anesthetist ("C.R.N.A.") within the State of Florida. Respondent's address of record is 4409 Hoffner Avenue, Suite 328, Orlando, Florida 32812. On or about March 13, 2003, Patient M.M. presented to Endosurg Outpatient Center (Endosurg) for a colonoscopy. The colonoscopy began at or about 7:16 a.m. According to the Respondent's Anesthesia Record, Patient M.M. had a blood pressure of 120/70 at 7:30 a.m., and a blood pressure of 140/84 and an oxygen saturation of 96 percent "at the end of case." Respondent began mouth-to-mouth resuscitation and CPR at or about 7:46 a.m., then provided oxygen via a bag-valve mask at or about 7:48 a.m., and then provided oxygen by intubation at or about 7:50 a.m. Section 464.018(1)(n), Florida Statutes (2002), subjects a licensed nurse anesthetist to discipline for failing to meet minimal standards of acceptable and prevailing nursing practice. ADDITIONAL FACTS: The indications for the endoscopic procedure performed on Patient M.M. were in relation to bright red blood per rectum and anemia. The endoscopic diagnosis confirmed by the procedure was diverticulosis and internal hemorrhoids. According to Patient M.M., this was the first colonoscopy she had ever had. In the history reported by Patient M.M. prior to the procedure, there was no report of chest pain, indigestion, heart burn, or nausea. The patient did report rectal bleeding. Patient M.M. provided a history of bronchitis, but it was noted that there were no recent problems with the bronchitis. In the recount of her past medical history, she made no reference to congestive heart failure, coronary artery disease, diabetes, atrial fibrillation, angina, heart murmur, heart valve problems, or irregular heart. She did have a history in her family of heart disease; the family member was her father. By history, the patient suffered from high blood pressure. At the time the patient was seen at Endosurg she was 67 years old, 5 feet 5 inches tall, and weighed 215 pounds. Respondent has practiced for 30 years in numerous settings. Respondent was an independent contractor recently employed at Endosurg. Over time she has met her obligations in relation to continuing education for her profession. When Respondent first saw Patient M.M. on the date in question, the patient was in the holding area adjacent to the procedure room. Respondent introduced herself to the patient and checked the intravenous access. The line had been placed and Respondent checked to make certain that the line was patent. Respondent explained to the patient that the patient would be given sedation. In particular, Respondent told the patient that she would be placed under conscious-sedation during the procedure. The patient responded that her son had had post- operative nausea and vomiting, having undergone sedation, but that the patient had experienced no problems with anesthesia in the past. Respondent listened to the patient's chest. The heart was regular, in that there were no audible sounds of irregularity or murmur at that time. The patient's chest was clear. No signs of wheezing or bronchi or rales were present that would indicate upper-respiratory difficulties. Respondent was aware that the patient suffered from hypertension. Before the procedure Respondent did not observe anything in the patient's demeanor which suggested that the patient was overly anxious. As the anesthesia record reflects, the administration of anesthesia by Respondent commenced at 7:15 a.m. and ended at 7:26 a.m. The procedure commenced at 7:16 a.m. and concluded at 7:25 a.m. Before providing the anesthesia, Respondent placed a blood pressure cuff on the patient, a pulse oximeter, an EKG monitor, and a pre-cordial stethoscope. The patient was anxious and Respondent administered a total of 2 mg of Versed. The Versed was administered twice. After waiting to see the reaction to the first administration, a second administration was provided. During the administration of this medication, Respondent discussed its subjective influence with the patient. Two other persons were in the procedure room with Respondent. They were the physician gastro-endrologist, who was performing that procedure, and an anesthesia technician. The doctor involved was Dr. Nehme Gebrayel. When the scope used to perform the procedure was inserted the patient winced. In response to those circumstances Respondent provided Fentanyl, an ultra-short acting narcotic in an amount considered appropriate to the circumstances. When the scope reached the area within the colon where the scope needed to be turned, the patient grasped the arm of the technician and dug her nails into his forearm. The physician called upon Respondent to provide other sedation to allow him to continue the procedure while providing some comfort to the patient. In response Respondent gave the patient 30 mg of Propofol, an hypnotic sedative with a short half-life. Later the patient began to dig her nails into the technician's forearm once more, which the technician reported to the physician. The physician told Respondent to provide additional sedation. Respondent gave the patient 30 mg more of Propofol. While the procedure was ongoing Respondent monitored the patient's vital signs. Before the procedure, the blood pressure was 142/100, the heart rate was 72. The second reading on blood pressure taken by Respondent during the procedure occurred between 7:18 a.m. and 7:20 a.m., with a reading of 126/66. Pulse oxygen readings that were recorded at the beginning and during the procedure reflected 98 percent and 95 percent saturation respectively. When the physician began to withdraw the scope at the end of the procedure, Respondent told the patient that the procedure was being finished and that the physician was taking the scope out. The patient responded by giving a "thumbs up" gesture. When the Doctor finished the procedure, Respondent asked the patient if the patient was doing "O.K." Respondent asked the patient if the patient was experiencing discomfort, the patient responded "not really." Respondent told the patient that the patient was being taken back to the holding area where she had been picked up before and brought into the procedure room. While the physician was still in the procedure room, Respondent went to the door and opened it into the holding area, and the nurse from the PACU at Endosurg came into the procedure room. Maureen Mayhew, R.N., was that nurse. When nurse Mayhew entered the procedure room, the vital signs in relation to blood pressure, pulse, and the pulse oximeter reading were still displayed on the monitor in the procedure room. Those readings at the end of the case were blood pressure 140/84, heart rate 74, respiratory rate 16 per minute and the saturated oxygen level 96 percent. At that time the patient responded to queries and stimuli. The reference to responding to queries means that the patient was able to converse with the Respondent. When Respondent turned over the care to nurse Mayhew, she told the other nurse that the patient had high blood pressure and a history of bronchitis but that the chest was clear when listened to prior to the procedure. Respondent explained that the patient had undergone a colonoscopy, in which 2 mg of Versed, 50 mg of Fentanyl, which is the equivalent to 1 cc and a total of 60 mgs of Propofol, divided into two doses had been provided. Respondent told nurse Mayhew that the patient was awake and talking and that her blood pressure had started at 140, had drifted down to 120 and was back at 140, as to systolic readings. After Respondent released the patient to the care of nurse Mayhew, she proceeded to address the next case. The administration of anesthesia to that patient commenced at 7:27 a.m. At about 7:45 a.m. a C.N.A. at Endosurg came into the procedure room where the next case was underway. The C.N.A. stated that there was a problem with Patient M.M., in that the patient was not responding as she had been. The C.N.A. asked that the doctor and Respondent come and see the patient. After arranging for someone to continue to monitor the patient that was being examined at that moment and with the placement of intravenous fluid with that patient to keep him hydrated, Respondent and the doctor left the procedure room and entered the holding area where Patient M.M. was found. When Respondent and the physician approached the patient, the patient was alone, flat on the bed. Respondent checked the patient's pulse at her neck, while the physician checked the patient's pulse at the wrist. Respondent called the patient's name and rubbed on the patient's chest. The patient made no response. The patient had no pulse. Respondent told the doctor "I don't have a pulse here." The doctor responded "Neither do I." When Respondent and the doctor addressed the patient in the holding area, they were uncertain when the patient had stopped breathing. The doctor commenced chest compressions as a form of CPR. Respondent leaned over the patient and breathed two quick breaths into the patient through mouth-to-mouth CPR. Respondent asked someone else employed at Endosurg to bring the CODE cart. Someone asked the Respondent if they needed to call 911. Respondent said, "yes" and the call was placed. Respondent was handed an ambubag with a valve mask to assist the patient in breathing. To check the bag's operation Respondent squeezed twice and found that the bag was not working. This bag belonged to Endosurg, and by inference Endosurg, not the Respondent is found to be responsible for its maintenance. During the inception of the mouth-to-mouth resuscitation provided by her, Respondent noticed that the patient's chest rose which is an indication that the patient was being ventilated. By contrast, the initial ambubag provided no evidence that ventilation was occurring. When the facility ambubag failed, Respondent asked another employee at Endosurg to go and pick up her personal ambubag that was located in another part of the procedure room. While someone went to retrieve Respondent's personal ambubag, the Respondent continued to provide mouth-to-mouth resuscitation while the physician gave closed chest compressions to the patient. During that time the chest was rising, indicating that the patient was making ventilatory efforts. When the second ambubag, belonging to Respondent, was handed to her, it was connected to oxygen and it performed as expected. The patient was given several quick breaths of the oxygen through the ambubag. Respondent then used a laryngoscope and an endotracheal tube to intubate the patient and the patient was intubated. While being ventilated through the endotracheal tube, Respondent used a stethoscope to listen to the breath sounds of the patient and she found evidence that the endotracheal tube was secure. While this was occurring the physician continued chest compressions. The physician also administered certain drugs to the patient to assist the patient. One drug being administered to the patient at the time was Epinephrine. The patient was then defibrillated. The defibrillator did not have a separate monitor. It was one in which the paddles associated with the defibrillator were not hooked to a device that would produce print strips of the results when the paddles were applied. This defibrillator belonged to Endosurg. The Respondent and the physician relied upon the EKG monitor hooked up to the patient to gain information and her status. When the Respondent and the doctor had come into the holding area, the patient was not on the monitor. The physician placed the leads on the chest of the patient to connect the monitor to reflect the pulse rate, if any were present. When the patient was first defibrillated and there was no change in the heart rhythm, another dose of Epinephrine was administered. About that time the fire rescue unit that had been summoned by the 911 call arrived. That was at 7:51 a.m. The fire rescue personnel included an EMT paramedic qualified to maintain the airway for the patient. Those persons took over the patient and prepared the patient for transfer. Respondent asked the doctor if it was acceptable to return to the procedure room and check the status of that patient. The physician gave her permission but Respondent did not return to the procedure room until the EMT paramedic had checked the position of the endotracheal tube in Patient M.M. Through the efforts made by Respondent and the physician the patient regained her pulse. A note in the patient's records refers to the existence of the heart rate and pulse when the patient was turned over for transport to a hospital. That hospital was the Villages Regional Hospital. There the patient was diagnosed with cardiac arrest and anoxic brain damage, encephalopathy. Subsequently the patient was transferred to Leesburg Regional Medical Center. The decision was eventually made to remove the patient from life support, given her condition. In an interview nurse Mayhew gave to an investigator with the Department of Health, relied upon by the parties at hearing, Ms. Mayhew told the investigator that five patients were in the PACU at Endosurg when Patient M.M. was transferred to that unit. At the time there was only one registered nurse and a single C.N.A. in the unit. Liz Singleton was the C.N.A. Ms. Mayhew told the investigator that Ms. Singleton indicated to Ms. Mayhew that the patient was alert and talking when the patient entered the unit. Ms. Mayhew said that she gave Patient M.M. a rapid assessment shortly after the arrival of the patient in the unit. Ms. Mayhew told the investigator that she noted that the Patient M.M. had declined from alert to responsive at that time. When checking the color and vital signs, a decrease in blood pressure was noted and the patient was placed in the Trendelenberg position (head down, feet raised) to try to increase the blood pressure. Ms. Mayhew mentioned giving Patient M.M. a sternal rub. The patient was noticed to blink her eyes and move her shoulder. Fluids were started, and the patient was given Romazicon intended to reverse the effects of anesthesia that had been provided to the patient during the procedure. Ms. Mayhew told the investigator that she gave C.N.A. Singleton instructions not to leave the patient's bedside and to give the patient one-on-one care. Ms. Mayhew then went to arrange for another C.N.A. to assist in the PACU. At some time during the care provided by nurse Mayhew, she indicated that there was a monitor for blood pressure, oxygen saturation, respiration and pulse and that the alert alarms were set. Nurse Mayhew told the investigator that she was starting an IV two beds away and heard the second C.N.A. talking to Patient M.M. just before the alarms went off. She said that Patient M.M. was in respiratory arrest and that she called a CODE, meaning nurse Mayhew called a CODE. Any entries concerning the vital signs in relation to Patient M.M. that were made following the procedure while the patient was in the holding area were made by C.N.A. Singleton, according to nurse Mayhew's statement. The monitor had printout capabilities at the time but was not activated. Notwithstanding these remarks attributed to nurse Mayhew in the interview process, it is found that when Respondent and the doctor addressed the patient in the holding area the monitor was disconnected. Although in her remarks made to the investigator nurse Mayhew said that the vital signs were recorded by the C.N.A., the record of nursing assessments reflecting the recording of the vital signs was signed by nurse Mayhew. They show that at 7:30 a.m. the patient's blood pressure was 78/46, with a pulse rate of 52, and a respiratory rate of 12. At 7:35 a.m. the blood pressure was 74/42, with a pulse rate of 40, and a respiratory rate of 14. The physician gave certain post-op orders concerning Patient M.M. which were noted by nurse Mayhew when she affixed her signature. One of those orders indicated that Ms. Mayhew was obligated to "notify physician for blood pressure less than 90/60, pulse >110." This order was not followed. EXPERT OPINION: Cenon Erwin Velvis, C.R.N.A., has been licensed in Florida for eleven years. He was called as an expert for Petitioner to testify concerning Respondent's care rendered Patient M.M. in this case. The witness was received as an expert. Both the Respondent and Mr. Velvis have provided anesthesia on numerous occasions while patients were undergoing colonoscopies. To prepare himself for the testimony, nurse Velvis reviewed medical records pertaining to Patient M.M. and the investigative report of the Department of Health. His opinion is that Respondent in caring for Patient M.M. fell below the standards expected of a C.R.N.A. when considering acceptable and prevailing nursing practice. Concerning his opinion, nurse Velvis believes that Patient M.M. was transferred to the PACU in an unstable condition, that Respondent did not remain with the patient long enough to ascertain this instability and the need for treatment and to conduct an ongoing evaluation secondary to the side effects of the anesthesia, and that once the patient experienced difficulties, the airway and circulatory system were not secured by Respondent in a timely manner. Nurse Velvis believes that the blood pressure reading at 7:30 a.m. of 78/46 and heart rate and pulse of 52 are low, dangerously so. According to nurse Velvis the normal range is 120/80 for blood pressure. There can be an acceptable 15 to 20 per cent departure from what is considered normal. This takes into account that nature of the procedure that the patient had undergone. The vital signs that were reflected at 7:30 a.m. demonstrate patient instability at 7:30 a.m., in Mr. Velvis' opinion. The Romazicon administered to the patient would not ordinarily be used given the amount of anesthesia provided the patient in the procedure. The patient's responsiveness had progressed to a point from what was initially assessed as responsive or responding to queries, to an unresponsive state. This would account for the administration of Romazicon, a reversal agent to the tranquilizer that had been used during the procedure. Nurse Velvis notes that the patient had gone from responding to inquiries to a state of unresponsiveness where the patient would only move when given painful stimuli. Mr. Velvis was aware that the blood pressure at 7:35 a.m. was 74/42, with a pulse rate of 40, indicating a further decline. The approximate time of arrest for the patient was 7:45 a.m. from records reviewed by Mr. Velvis. Mr. Velvis believes that the Respondent was responsible for verifying the patient's vital signs upon admission to PACU. He also originally expressed the opinion that Respondent failed to utilize the intubation equipment in a timely fashion to restore breathing following the emergency. Mr. Velvis concedes that if the cardiac arrest that occurred with Patient M.M. were related to anesthesia, the respiratory response by the patient would be lowered. But the recording of a respiratory rate of 12 at 7:30 a.m. and 14 at 7:35 a.m. does not satisfy Mr. Velvis concerning the quality of ventilation in the patient, even with the efforts of the patient being recorded. He also makes mention that the level of oxygen saturation at those times was unknown when reviewing the record. He does acknowledge that a respiratory rate of 14 as such is not consistent with respiratory arrest. Mr. Velvis acknowledges that nothing in the record indicates that nurse Mayhew notified the doctor when the low blood pressure readings were taken at 7:30 a.m. and 7:35 a.m., contrary to post-op orders. When provided a hypothetical under interrogation at hearing, that reflects the facts that have been reported here concerning the Respondent and the doctor in their effort to restore Patient M.M.'s breathing, Mr. Velvis retreated from his opinion that the airway and circulatory system of the patient was not secured in a timely manner when confronted with the crisis. While Mr. Velvis changed his opinion during cross- examination at hearing concerning the response by Respondent leading to the defibrillation, he still continued to express the opinion that Respondent fell below the standard of care and was responsible for hypoxia in the patient, the patient not breathing. He also restated his opinion that Respondent was below the standard of care for her release of the patient from the procedure room into the PACU in an untimely manner. Mr. Velvis expresses the opinion that immediate patient care was the Respondent's responsibility but in the atmosphere of team work the physician was the captain of the ship. Although the physician was the captain of the ship, the Respondent was responsible to do what was most important for the patient, according to Mr. Velvis. Mr. Velvis recognizes that nurse Mayhew would have been more helpful if she had notified Respondent and the physician earlier about Patient M.M.'s condition in the holding area, and Ms. Mayhew's error in leaving the patient when the patient was unstable. Mr. Velvis expresses the opinion that the mechanism behind the cardiac arrest in Patient M.M. was a lack of oxygen, in that the airway was not secure. Mr. Velvis in his testimony concedes that the patient could have had cardiac failure not due to a problem with respiration. Michael A. Binford, M.D., was called by Respondent as an expert. He is a practicing anesthesiologist in Florida who completed his anesthesiology residency approximately ten years ago. He works with C.R.N.A.s in his practice and as such is able to offer opinion testimony about the performance of C.R.N.A.s in their practice. He is familiar with the type of procedure which Patient M.M. was undergoing and the drugs administered to provide anesthesia. Having reviewed the patient's records and the investigative report from the Department of Health, his opinion is that Patient M.M. was stable when transferred from Respondent's care to nurse Mayhew's care. That opinion is based upon vital signs recorded at the commencement, during, and at the end of the procedure. From what he saw in the record concerning the medication administered to the patient during the procedure, it was appropriate. Nothing that he saw in the record made Dr. Binford believe that the Respondent should have stayed with the patient for a longer period of time, given the amount of medication provided. By contrast Dr. Binford refers to the vital signs recorded when the patient was under nurse Mayhew's care at 7:30 a.m. and 7:35 a.m. Those are not vital signs of a patient in a stable condition. Dr. Binford believes that the patient was deteriorating at that time and that nurse Mayhew violated the physician's post-op order by not immediately notifying the doctor of the vital signs she found. Dr. Binford in referring to nurse Mayhew's statement given to the investigator, reads the statement to indicate that the patient was stable when entering the PACU but declined from alert to responsive. To Dr. Binford this reflects a change in mental status in the patient. Definitive evidence in the change in status is borne out by the vital signs taken at 7:30 a.m., and 7:35 a.m., in Dr. Binford's opinion. Although the Romazicon given by Nurse Mayhew would not have been a drug of choice for Dr. Binford, he understands that nurse Mayhew may have considered it appropriate to provide an antidote to the Versed by using Romazicon. Dr. Binford did not believe that the Versed would have caused the low vital signs encountered by nurse Mayhew. Having reviewed the autopsy report related to Patient M.M., Dr. Binford believes that a cardiac event was associated with the lower vital signs. He does not believe that the respiratory rate of 12 and 14 found at 7:30 a.m. and 7:35 a.m. respectively are consistent with respiratory arrest. Dr. Binford explains that the process involved with a heart attack, which is also referred to a myocardial infarction, is in relation to the entire heart or some segment within the heart not getting sufficient oxygen. If the patient is not breathing for a period of time, the total level of oxygen in the blood drops significantly. That is a possibility. The second possibility is that if there is plenty of oxygen in the blood, but one of the blood vessels supplying the heart muscle becomes blocked and no blood can get past the obstruction, this can also cause oxygen deprivation. Either explanation can cause damage to the heart and the brain. The first example is one in which problems are experienced in getting air and oxygen into the lungs, that can be picked up and transported around the body and the second explanation involves a problem with getting the blood flow into the area as needed. The first example related to problems of respiration is referred to by Dr. Binford as a primary respiratory event. The second example is referred to as a primary cardiac event, involving restricted blood flow. In Dr. Binford's opinion if the patient has respiratory difficulty, the respiratory rate ranges from 0 to 8, which was not the case here. In Dr. Binford's opinion neither the Versed or Romazicon were responsible for the vital signs shown in the patient while she was in the holding area. In Dr. Binford's opinion the cause of the patient's decline was indicative of a primary cardiac event, as opposed to a primary respiratory event and the anesthesia as a causative agent would not explain it. He expresses this opinion within a reasonable degree of medical certainty. Given his knowledge of the case, Dr. Binford did not find any deficiencies in the way the Respondent treated the patient. Within a reasonable degree of medical certainty Dr. Binford believes that the Respondent met her obligations as to the basic standards for her profession in the pre-operative phase, during the procedure, upon the release of the patient to nurse Mayhew and in response to the emergency in the holding area. Having considered the opinions of both experts, the opinion of Dr. Binford is more persuasive and is accepted as it exonerates Respondent for her conduct.
Recommendation Based upon the facts found and the conclusions of law reached, it is RECOMMENDED: That a final order be entered dismissing the Administrative Complaint. DONE AND ENTERED this 8th day of December, 2005, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of December, 2005. COPIES FURNISHED: Irving Levine Assistant General Counsel Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Damon A. Chase, Esquire Chase Law Offices, P.A. Post Office Box 196309 Winter Springs, Florida 32719 Alex Finch, Esquire 2180 Park Avenue, Suite 100 Winter Park, Florida 32789 Dan Coble, Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether the Agency for Health Care Administration (AHCA or Agency) was entitled to change the rating of Gulf Coast Convalescent Center (Gulf Coast) from Standard to Conditional.
Findings Of Fact Gulf Coast is a nursing home located in Panama City, Florida, which is duly licensed under Chapter 400, Part II, Florida Statutes. AHCA is the state agency which licenses and regulates nursing homes in the state. As such, it is required to evaluate nursing homes in Florida, pursuant to Section 400.23(8), Florida Statutes. AHCA evaluates all Florida nursing homes at least every 15 months and assigns a rating of Standard or Conditional to each licensee. In addition to its regulatory duties under Florida law, the Agency is the state "survey agency" which, on behalf of the federal government, monitors nursing homes which receive Medicaid or Medicare funds. Ms. Bonnie Cile Baxter is employed by AHCA in the Division of Managed Care and Health Quality Assurance, Area Two. She is a registered nurse specialist and a graduate of the Florida State University School of Nursing. She has been a registered nurse for 27 years. She currently conducts surveys of nursing homes as required by state and federal law in AHCA's Area Two. Ms. Baxter visited Gulf Coast while conducting a licensure survey report. The survey began on March 13, 2000, and ended on March 15, 2000. As a result of the survey, a Statement of Deficiencies was issued on March 15, 2000. This report is referred to as a TAG 314. The report alleged Class II deficiencies. A Class II deficiency occurs when the outcome of the resident care directly affects the health, safety, or security of the resident. The TAG 314, set forth on a "2567" form, entered into evidence as Petitioner's Exhibit 1, is, in effect, the charging document. The residents to be checked were determined off-site by AHCA, prior to the survey. The information used to make these decisions was provided by the facility. The focus of the survey was pressure sores and nutrition and the four residents who were observed are referred to as Residents 16, 26, 22, and 15. Resident 16 Resident 16 was approximately 75 years of age. Ms. Baxter observed Resident 16 on March 13, 2000 at 9:00 a.m. Ms. Baxter observed that Resident 16 had a stage IV pressure sore. Pressure sores are evaluated in stages, beginning with stage I; a stage IV is the worst stage. A stage IV pressure sore may be open or closed, and it involves more than just the outer skin. A stage IV pressure sore involves severe damage to tissue. When evaluating the treatment of a resident with pressure sores, the evaluator observes the assessment and care plan and determines whether nutritional considerations have been addressed. The plan is evaluated to determine if it is sufficiently aggressive. What is implemented depends on the resident's need and the resident's desire. If the resident is incompetent to determine what care the resident wishes to accept, then a guardian may make the determination. Resident 16 was unable to make cognitive choices. Kimberly Roland, the Special Services Director at Gulf Coast at the time of the survey tried to contact Developmental Services of the Department of Children and Family Services with regard to a care plan for Resident 16 but the Agency asserted that it did not get involved with medical decisions. Ms. Baxter also tried, unsuccessfully, to determine who was authorized to make medical decisions on behalf of Resident 16. Resident 16 had been admitted to Gulf Coast on September 16, 1999. Facility staff noted that Resident 16 was first observed with a stage I pressure ulcer on February 1, 2000. The care plan developed by the facility in the case of Resident 16 did not facially address the pressure sore problem because it lacked specificity. Excellent nutrition serves to prevent pressure sores and to promote their healing. During the period subsequent to February 1, 2000, Resident 16 was without dentures, and this negatively affected her ability to ingest the type of foods which would address Patient 16's nutritional needs. There were discrepancies in Exhibit's 5, 7, and 8. Exhibit 5, which memorialized a one-time visit with a physician from Bay Psychiatric Services on February 12, 2000, indicated that Resident 16 did not exhibit symptoms of tardive dyskinesia, yet Exhibit 7 indicates that Resident 16 could not wear dentures because of involuntary movements related to tarsive dyskenesia on February 23, 2000. Exhibit 8, nurses' notes, indicate the presence of tardive dyskenesia involving movements of the tongue and body on January 27, 2000. Petitioner's Exhibit F demonstrated that Resident 16 had tardive dyskenesia symptoms, which resulted from long-time Mellaril use. The symptoms reported included involuntary movements of the tongue, which precluded the use of dentures. These involuntary movements were present on September 19, 1999. Mr. Gilliland, a licensed practical nurse with many years' experience working in nursing homes, stated he noticed that Resident 16 manifested involuntary movements of the tongue and body in December, 1999. If a person has tardive dyskenesia, it may preclude the utilization of dentures. The disappearance of Resident 16's dentures indicated a deficiency in security procedures but even if Resident 16 had dentures available, Resident 16 could not masticate hard food. Resident 16 had been on a mechanical soft diet prior to January 20, 2000. Subsequently, when Resident 16 no longer had the ability to masticate food, Resident 16 was put on a pureed diet. Resident 16's condition was the subject of an "at risk" meeting by the facility staff on February 15, 2000. Subsequently, Resident 16's nutritional needs were addressed with an enhanced diet. Resident 16 was provided with multi- vitamins and milkshakes twice a day in addition to other food. From February to March 2000, Resident 16 lost weight. The facility staff's efforts to provide Resident 16 with proper nutrition were appropriate under the circumstances. The first pressure sore on Resident 16 was found on February 1, 2000, and it was already a stage II without drainage. On February 18, 2000, the sore had advanced to a stage III and an additional pressure ulcer had formed on Resident 16's hip. This latter ulcer was also a stage II. By February 25, 2000, the ulcer on the hip changed to stage III and there was some draining. Subsequent to the inception of the ulcers, Resident 16 had been placed on a pressure reduction mattress. On March 3, 2000, more frequent turning was ordered by her attending physician. Mr. Gilliland observed that Resident 16 was mentally incapable of decision-making. Mr. Gilliland spent a lot of time with Resident 16. He was emotionally attached to Resident 16 who, to him, ". . . was like a little child." He spent a lot of time with Resident 16, kept Resident 16 clean and dry, and turned her frequently. At the time of the survey, the representatives of the state insisted that Resident 16 be fed through a tube. Dr. Haslam, Resident 16's physician, would not have ordered tube feeding had not the surveyors insisted that it be done. Resident 16 objected when Mr. Gilliland put the feeding tube in her nose. Resident 16 removed the tube. Mr. Gilliland put the tube in three or four times. Each time, Resident 16 removed it. When Dr. Haslam was informed of this, he told Mr. Gilliland that he could discontinue using the feeding tube. Resident 16 ate until two days before she died. When Resident 16 was admitted to Gulf Coast on September 3, 1999, Resident 16 could ambulate with assistance and was incontinent of bladder and bowel. By the time of the survey, Resident 16 could not walk at all and was bladder and bowel incontinent. At the time of the survey, and for several months before the survey, Resident 16 was bowel and bladder incontinent, had impaired mobility, and was an insulin-dependent diabetic. Resident 16 had occlusion of the arteries and veins of her lower extremities, which resulted in poor circulation. These are high-risk conditions for pressure wounds. Resident 26 Resident 26 was admitted to Gulf Coast on June 7, 1998. Resident 26 required extensive care with daily living activities and was approximately 83 years old at the time of the survey. On August 14, 1999, a stage I pressure sore was observed on the coccyx of Resident 26. By August 20, 1999, the pressure sore had become a stage II. By October 1999, the pressure sore on the coccyx had become a stage IV, and pressure sores had developed on the Resident 26's knee and on the left heel. Both of these sores were diagnosed as stage II. By November 11, 1999, the pressure sore on the coccyx was causing pain to Resident 26. It was determined on November 16, 1999, that the wound on the coccyx was infected with methicellin- resistant staphylococcus aureus (MRSA). MRSA is a type of infection that is resistant to antibiotics. It is communicable, and it is imperative that it be controlled. Vancomycin is the antibiotic of choice when treating MRSA. Resident 26 was administered Vancomycin and procedures were instituted to determine its effectiveness. The facility's staff determined that it would be best if a PICC line was installed in Resident 26. A PICC line is a method for administering antibiotics intravenously. In the case of Resident 26, records which tracked the status of the MRSA, were inadequate. Resident 26 refused to allow the PICC line to be placed. There is no indication whether Resident 26 refused Vancomycin administered in some other manner. On November 19, 1999, Dr. Ernest Haslam was notified of Resident 26’s refusal to allow installation of the PICC line. This information was not available at the time of the survey. At the time of the survey there were no documents indicating that the infection was being properly tracked or that there was an adequate treatment plan. The care plan for the treatment of Resident 26's pressure sores addressed providing proper nutrition, which included dietary supplements and pressure-relieving devices. Resident 26 was offered a feeding tube but Resident 26 declined. The implementation of the feeding tube was discussed by Resident 26's doctor with Resident 26's family and together they decided not to use it. The nutrition provided for Resident 26 was acceptable under the circumstances. Resident 26 was, at the time of the survey, and for several months before the survey, incontinent of both bowel and bladder. Resident 26's rheumatoid arthritis was so severe that Resident 26 was required to ingest anti-neoplastic drugs, which can kill cells. Resident 26 was admitted with a diagnosis of failure to thrive. Resident 26 was required to take Prednisone, which can contribute to the formation of pressure sores. Resident 26's albumin level was high, and a high albumin level promotes the formation of pressure sores. Resident 26 had a living will and had provided instructions not to resuscitate and resisted necessary treatment. These factors put Resident 26 at a high risk for pressure sores. Resident 22 Resident 22 was 67 years of age upon admission to Gulf Coast on May 12, 1999. Resident 22 had an open surgical wound on the hip upon admission, along with a fractured hip and gastrointestinal bleeding. Resident 22 also was anemic and had cardiovascular disease. On July 7, 1999, Resident 22 had a stage II pressure sore on the right heel, which had been present on admission. On September 2, 1999, it was noted that the left hip was infected and antibiotics were administered. On October 13, 1999, it was noted that Resident 22 had a stage III pressure sore on the right heel and a stage II open area on the right lateral foot. Poor nutrition was not a contributing factor with regard to Resident 22's pressure sores. On May 29, 1999, bilateral profo boots were prescribed for Resident 22, to be used for positioning of the feet while in bed. Dr. Osama Elshazly ordered the use of the profo boots. The use of profo boots was not included in the plan of care. Dr. Elshazly discontinued the use of the boots on January 1, 2000. There was speculation among the facility staff that the profo boots may have contributed to the pressure sores. Resident 22, at the time of the survey, and for several months before the survey, had pressure sore risk factors of diabetes mellitus, end-stage renal disease, coronary artery disease and arteriosclerosis obliterans. This latter condition means that the circulation in Resident 22's lower extremities was poor. Resident 15 Resident 15 is 87 years of age. Resident 15 was admitted to Gulf Coast on September 13, 1994. Upon admission, Resident 15 had ingrown toenails, a deformed left hammer toe, and other medical conditions involving the feet. Resident 15 required extensive assistance from staff in the activities of daily living and received nutritional support in the form of tube feeding. On December 17, 1999, Resident 15 was admitted to the Bay Medical Center due to a cerebrovascular accident, which is commonly referred to as a "stroke." Resident 15 was returned to Gulf Coast on December 23, 1999. After the cerebrovascular accident, Resident 15 was even less mobile and suffered a decline both mentally and medically. On March 1, 2000, Resident 15 was noted as having a pressure sore on her left bunion. Staff informed Ms. Baxter that they believed it occurred because Resident 15 had limited mobility. Resident 15, at the time of the survey and for several months before the survey, had pressure sore risk factors of bowel and bladder incontinence, congestive heart failure, and peripheral vascular disease. Resident 15 was a noninsulin- dependent diabetic.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a final order finding Petitioner not guilty of the alleged deficiencies and reinstating Petitioner's license rating to Standard as of March 15, 2000. DONE AND ENTERED this 27th day of December, 2000, in Tallahassee, Leon County, Florida. HARRY L. HOOPER 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 27th day of December, 2000. COPIES FURNISHED: Christine T. Messana, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Donna H. Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308
