The Issue Whether Petitioner's licensure status should be reduced from standard to conditional.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: AHCA is the state Agency responsible for licensure and regulation of nursing homes operating in the State of Florida. Chapter 400, Part II, Florida Statutes. IHS operates a licensed nursing home at 4033 Beaver Lane, Port Charlotte, Florida. The standard form used by AHCA to document survey findings, titled "Statement of Deficiencies and Plan of Correction," is commonly referred to as a "2567" form. The individual deficiencies are noted on the form by way of identifying numbers commonly called "Tags." A Tag identifies the applicable regulatory standard that the surveyors believe has been violated and provides a summary of the violation, specific factual allegations that the surveyors believe support the violation, and two ratings which indicate the severity of the deficiency. One of the ratings identified in a Tag is a "scope and severity" rating, which is a letter rating from A to L with A representing the least severe deficiency and L representing the most severe. The second rating is a "class" rating, which is a numerical rating of I, II, or III, with I representing the most severe deficiency and III representing the least severe deficiency. On February 4 through 7, 2002, AHCA conducted an annual licensure and certification survey of IHS to evaluate the facility's compliance with state and federal regulations governing the operation of nursing homes. The survey team alleged several deficiencies during the survey, only one of which is at issue in these proceedings. At issue is a deficiency identified as Tag F322 (violation of 42 C.F.R. Section 483.25(g)(2), relating to a facility's duty to prevent aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and nasal-pharyngeal ulcers in residents who are fed via naso-gastric or gastrostomy tube). The deficiency alleged in the survey was classified as Class II under the Florida classification system for nursing homes. A Class II deficiency is "a deficiency that the agency determines has compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services." Section 400.23(8)(b), Florida Statutes. The deficiency alleged in the survey was cited at a federal scope and severity rating of G, meaning that the deficiency was isolated and caused actual harm that is not immediate jeopardy. Based on the alleged Class II deficiency in Tag F322, AHCA imposed a conditional license on IHS, effective February 7, 2002. The survey found one instance in which IHS allegedly failed to ensure appropriate treatment for a resident fed by a naso-gastric or gastrostomy tube. The surveyor's observation on Form 2567 concerned Resident No. 2: Based on observation, review of resident record and facility policy and procedure, and interview with the nutrition and administrative, and nursing staff, the facility failed to notify the Registered Dietician of a physician ordered consult requested secondary to elevated laboratory values and need for reassessment of resident's nutritional and fluid needs; failed to complete the physician ordered dietary consult; failed to review physician orders and review resident laboratory values when completing the January 2002 tube feeding review resulting in no reassessment of the resident's nutritional needs and no readjustment in the resident's tube feeding with the subsequent negative outcome of metabolic abnormalities and dehydration secondary to excessive protein intake for 1 (Resident No. 2) of 7 residents reviewed for tube feeding from a total sample of 22 active sampled residents. The findings include: Resident No. 2 was admitted to the facility on 09/07/01 with diagnoses including Type 2 Diabetes, Senile Dementia, Chronic Bronchitis, Aspiration Pneumonia and Depression. The resident had a gastronomy tube for feeding and was receiving nothing by mouth. Review of the resident hospital laboratory data dated 9/5/01, indicated that the resident was admitted to the facility with normal laboratory values except an elevated Glucose level of 195 (reference range 75-109 mg/dL). The resident's Blood Urea Nitrogen (BUN) was within normal limits at 12 mg/dL (reference range 5-25 mg/dL); Creatinine was within normal limits at 1.2 mg/dL (reference range 0.5-1.4 mg/dL); BUN/Creatinine Ratio was 10:1 within normal limits of 10:1. The resident's albumin level dated 9/1/01, indicated a moderate depletion of protein stores at 2.6 g/dL (reference range 3.4-5.0 g/dL). The resident had clear urine with a normal urine specific gravity of 1.010 (reference range 1.001-1.030). Review of the initial Nutritional Assessment completed on 09/10/01, revealed that the resident's estimated nutritional needs were 1320 calories and 64 grams of protein (1.5 grams/kg body weight) with 1290 cc of fluid (30 cc/kg body weight). The resident's weight on admission was 94.4 pounds with an ideal body weight range of 95 pounds +/- 10 percent. The resident's weight in August 01 was documented as 96.8 pounds. Resident's height was 50 inches. The Registered Dietician (RD) recommended a change in the tube feeding to Resource Diabetic at 60 cc per hour with 100 cc of water every shift (300 cc of additional water) to provide 1440 calories, 90 grams of protein (2.1 grams of protein/kg body weight) and 1509 cc of free water. The RD documented that the resident had a need for extra protein secondary to a low albumin. (This tube feeding provided an additional 120 calories and 26 grams of protein a day beyond the resident's estimated nutrient needs.) Review of the Enteral Feeding Flow Sheet revealed that the RD recommended increasing the tube feeding further on 10/03/01, secondary to weight loss to Resource Diabetic at 75 cc per hour with no recommendation to increase the fluid flushes. It was documented that the resident's weight decreased 3.2 percent without a specified period of time. The resident's current weight was documented as 93.8 pounds. The RD did not recalculate the nutritional needs based on the current weight. She documented that the increase in tube feeding would provide 1800 calories (41 grams/kg) with 113 grams of protein (approximately 2.7 grams/kg body weight) and 1812 cc of free fluid plus 30 cc of fluids with medications. (This tube feeding provided an additional 480 calories and 49 additional grams of protein beyond the resident's estimated nutrient needs.) The note further documented that the resident's blood sugars were ranging from 122-141 mg/dL, no other labs were documented or requested. Review of the Enteral Feeding Flow Sheet dated 11/20/01, revealed that the resident remained on this tube feeding and water flushes and gained an additional 4 pounds in one month. The RD documented to continue with the current Plan of Care. The resident continued to receive an additional 480 calories (40 calories/kg) and 49 grams of protein (approximately 2.5 grams/kg) from this formula. Review of the Enteral Feeding Flow Sheet dated 12/07/01, revealed that the resident continued on the tube feeding and flushes and gained another 2 pounds. Review of physician telephone orders dated 12/19/01, revealed that the physician increased the water flushes to 150 cc every 6 hours to provide 600 cc of fluid per day in addition to the tube feeding, an increase of 300 cc per day. Review of the physician's progress notes dated 12/22/01 at 4:50 P.M., indicated that the resident had an elevated BUN of 84 mg/dL and an elevated glucose of 128. The physician documented that the resident had azotemia without increased sodium and questioned a gastrointestinal bleed. He further documented that the resident did not look dehydrated clinically and that her Type 2 Diabetes was improved. The physician ordered labs, check the stool for blood and was receiving [sic] increased water through the PEG tube (feeding tube in the stomach). Review of nurses notes dated 12/22/01 at 1800, revealed the stools were checked for blood with negative results. Review of the resident's lab data dated 12/18/01, revealed that the resident had a normal sodium and potassium level and an elevated BUN of 84 mg/dL (reference range 6-28 mg/dL). The resident's creatinine level was normal at 1.1 mg/dL (reference range .2-1.5 mg/dL). Glucose was elevated at 128 mg/dL (reference range 60-115 mg/dL). The BUN/Creatinine Ration [sic] had increased from normal to 76:1 and the calculated serum osmolality was 323 mOsm/kg H2O (normal values 285-295 mOsm/kg H2O). (These lab values were indicative of excessive protein intake and possible dehydration). Review of lab data obtained 12/24/01, indicated that the resident's BUN remained at 84 mg/dL, Glucose was normal at 90 mg/dL and the resident had an elevated white blood cell count indicative of infection. Serum osmolality remained elevated at 316 mOsm/kg H2O. BUN/Creatinine Ratio remained at 76:1, indicative of excessive protein intake and possible dehydration. The nurse had noted on the lab work form that the resident had tested negative for blood in her stool X 2 on 12/25/01 and the resident's whiteblood cells had been normal in September 2001. The labs were faxed to the physician on 12/26/01. Further review of the physician's telephone orders revealed that a dietary consult was ordered on 12/28/02 [sic]. Review of the dietary progress notes and Enteral Feeding Flow Sheets revealed that the consult had not been completed. The resident remained on the tube feeding at 75 cc per hour which provided 1800 calories, 113 grams of protein and 2112 cc of free fluid. (480 additional calories: 40 calories/kg; 49 grams additional protein: 2.5 grams/kg and approximately 35 cc of fluid/kg per day). The next documented nutritional review was completed on 1/14/02. The RD reassessed the resident's calorie needs to add 500 calories for weight gain with a total of 1820 calories per day. Protein needs were reassessed at 72 grams per day (1.5 grams/kg based on current weight). Fluid needs were reassessed at 30 to 34 cc/kg body weight or 1440 to 1632 cc per day. The resident's weight was documented at 106 pounds, a 6.4 pound weight gain (6.4 percent) in one month. There was no indication that the RD addressed the consult ordered 12/28/01 or the abnormal lab data from 12/18/01 and 12/24/01. Accuchecks (blood sugar levels) were noted on the flow sheet an [sic] ranging from 123-170 mg/dL. It was noted that the resident was receiving multivitamins with minerals. Review of the progress note that accompanied the flow sheet revealed that the RD documented on 01/14/-2, that the resident continued to gain weight on the tube feeding, that the accuchecks were elevated and "MD aware." Her recommendation was to continue with the current Plan of Care. Observation of the resident on 02/04/02 at 11:32 A.M., revealed a petite, frail woman sitting in a geri-chair propped up with pillows and a splint on her left hand. The resident's tube feeding was running at 75 cc per hour. Skin appeared smooth with good skin turgor, lips were dry. Resident had mild temporal wasting. Observation of the Foley catheter bag 02/05/02 at 11:15 A.M., revealed 125 cc of moderately yellow urine in the bag with sediment in the tubing. Interview on 02/04/02 at 2:05 P.M., with the consultant RD, who had completed the assessment on 01/14/02, revealed that she had not reviewed the physician orders or lab data when she completed the assessment. She stated she did check the resident's daily blood sugar levels. She stated the resident's fluid needs were being met at the time of the assessment and the resident was gaining weight. She confirmed that she did not assess the resident's protein intake from the formula versus the resident's estimated needs. The RD stated that the Resource Diabetic is high in protein but that is the only diabetic formula available on the formulary. She stated that after discussion with the surveyor, she would reassess the resident today and check with the physician regarding the rate of the tube feeding to provide less protein. Further interview with the RD on 02/04/02 at 3:00 P.M., revealed that she had spoken to the RD who covers the C wing and that RD told her that she had been on vacation during the time the RD consult was ordered. The consultant RD confirmed that the facility had not contacted her regarding the consult during her visits to the facility. She again stated that she was planning to decrease the protein in the tube feeding and keep the fluid flushes at 150 cc every 6 hours. She further stated that it would be difficult to decrease the protein to the resident's estimated needs due to the need for use of the diabetic formula. Review of the dietary progress note completed on 02/04/02, after surveyor intervention, indicated that the resident had increased to 107.2 pounds and was now above ideal body weight. Recalculation of the the [sic] resident's calorie needs was estimated to be approximately 1400 calories per day. Protein was reestimated [sic] at 1.2 grams/kg body weight or 57.6 grams per day. Fluid needs were calculated at 30-34 cc/kg body weight or 1440 to 1632 cc per day. The RD recommended to decrease the tube feeding to Resource Diabetic at 55 cc per hour to provide 1399 calories with 83 grams of protein (1.6 to 1.7 grams/kg body weight). Total free fluids provided would be 1708 cc per day (approximately 35 cc/kg/body weight). The RD also recommended lab data to assess hydration status and visceral protein stores. Review of the physician telephone orders dated 2/4/02, revealed that the physician approved the decreased [sic] in the tube feeding. Review of the lab data obtained 2/5/02, revealed that the resident's BUN remained elevated at 71 g/dL. The Creatinine was 0.9 mg/dL with the BUN/Creatinine ratio remaining elevated at 78:1. Calculation of the serum osmolality was 318, indicative of continued excessive protein intake and possible dehydration. The resident serum albumin did improve to 3.2 grams/dL. Further review of the dietary progress notes written 02/06/02, revealed that the RD recommended contacting the physician regarding the abnormal labs. She recommended increasing the fluid flushes to 150 cc every 4 hours which would provide an additional 900 cc of free fluid per day. The RD further documented that if the BUN did not show improvement in one week with the increased fluid flushes, a change in the type of formula would be necessary. She recommended Fibersource that has a protein level of 45 grams/1000 cc versus the resident's current Resource Diabetic which has 63 grams/1000 cc. Interview on 02/06/02 at 2:30 P.M., with the Administrator, Director of Nursing and 2 RD's confirmed that the RD's had not been notified of the 12/28/01 consult, that they do not get notified when lab data is abnormal unless they are verbally told by nursing. The full-time RD stated that she had originally assessed the resident's protein needs at 1.5 grams/kg body weight secondary to the low albumin and the resident's poor appetite. She stated that she was providing the extra protein secondary to having to use the diabetic tube feeding formula that was available in the formulary and meet the resident's calorie needs. The Director of Nursing stated that they had formulas from other companies in the building and that the facility could get a different diabetic formula if needed. The RD's agreed that the resident needed to be reassessed. Interview with the Director of Nursing on 02/07/02 at 12:05 P.M., revealed that she had reviewed the resident's record and had nothing else to bring the surveyors after reviewing the record and nothing else to offer. She stated that she that [sic] there were issues and that the facility would work on them. Cynthia Lehman, a public health nutrition consultant, was the survey team member who recorded the observation of Resident No. 2. Ms. Lehman's findings were based on her observations of Resident No. 2, a review of the resident's medical records and of the facility's policies and procedures, and interviews with IHS staff. At the hearing, IHS did not contest the accuracy of the factual findings set forth by Ms. Lehman, though it did contest AHCA's conclusion that Resident No. 2's elevated BUN level was caused by excessive protein intake. Resident No. 2 was a 82-year-old female first admitted to IHS on August 15, 2001, after a hospital stay for intravenous hydration. She had been admitted to the hospital with severe dehydration with azotemia, which is the retention of excess nitrogenous compounds in the blood caused by the failure of the kidneys to remove urea from the blood. Azotemia is associated with a high blood urea nitrogen ("BUN") level. Resident No. 2's BUN level on August 10, 2001, was 37 mg/dL. Normal limits of BUN are 5-25 mg/dL. Resident No. 2 was a small woman, 4'2" tall, and weighed 96.8 pounds. She suffered from diabetes, chronic obstructive pulmonary disease ("COPD"), chronic pancreatitis, hypothyroidism and heart disease. Upon admission to IHS, Resident No. 2 was bed-bound in a fetal position, lethargic and uncommunicative. She had skin tears on her heels and coccyx. During her first admission, Resident No. 2 ate poorly and had difficulty swallowing. The speech therapist at IHS determined that she would require tube feeding to maintain nutrition. Resident No. 2 was therefore readmitted to the hospital for placement of a percutaneous endoscopic gastrostomy tube, or "PEG tube." She was readmitted to IHS on September 6, 2001. Her condition was the same as on her first admission, with the exception of the PEG tube. Laboratory values were taken of Resident No. 2 during her second hospital stay. Of relevance to this proceeding, her blood urea nitrogen ("BUN") level on September 5 was 12 mg/dL, within normal limits of 5-25 mg/dL. She showed a moderate protein deficiency. Her albumin level was 2.6 g/dL, below normal limits of 3.4-5.0 g/dL. The IHS dietician, Carol Gathy, assessed Resident No. 2 upon her September 6 admission. She estimated that the resident required 1,320 calories and 64 grams of protein per day to maintain nutrition. Ms. Gathy noted that Resident No. 2 had a history of poorly controlled diabetes and that her accuchecks (blood sugar monitoring tests) were high. Resident No. 2's medical history indicated that she was prone to fall into azotemia. Ms. Gathy determined that the first priority was bringing Resident No. 2's diabetes under control, and for that reason recommended a product called Resource Diabetic for her tube feeding. Resource Diabetic is recommended for diabetics because it has a lower ratio of simple sugars than other tube feeding formulas. The tube feeding was initially provided at 60 cc/hour, with water flushes of 300 cc/day. This provided Resident No. 2 with 1,440 calories and 90 grams of protein per day. At the recommended levels, Resource Diabetic provided calories and protein in excess of Resident No. 2's estimated needs. Ms. Gathy thought this necessary to assist Resident No. 2 in gaining weight and replenishing her protein stores. The resident's thinness made her prone to pressure sores, as indicated by the skin tears on her heels and coccyx. Ms. Gathy thought that the extra protein would raise Resident No. 2's low albumin levels and enable healing of the existing skin tears, and that the extra calories would provide some "padding" to prevent future skin tears. On October 3, 2001, Ms. Gathy noted a three-pound weight loss for Resident No. 2 and recommended that the tube feeding be increased to 75 cc/hour. This increased Resident No. 2's intake to 1800 calories and 113 grams of protein per day. From early October through November, IHS performed daily accuchecks and determined that Resident No. 2's blood sugar and glucose levels were normal. Resident No. 2 was adjusting well to tube feeding and gaining weight. Her skin tears had healed and her skin was intact. Aside from the accuchecks, no other laboratory tests had been taken since her admission to IHS on September 6, 2001. The attending physician ordered lab work on December 18, 2001. Resident No. 2's BUN level was 84 mg/dL, well above the normal limits of 5-25 mg/dL. Evidence produced at the hearing indicated that an elevated BUN level over a long period of time can have negative effects, including renal failure. A BUN level must reach 100 mg/dL to be considered "critical," but a level of 84 mg/dL is considered abnormally high. Because no lab work was performed between September 5 and December 18, 2001, IHS did not know how long Resident No. 2's BUN level had been elevated. On December 19, 2001, the physician ordered an increase in the water flush through the PEG tube in an effort to bring down the BUN level. The "flush" is simply free water in the tube feeding that hydrates the resident and flushes out some of the excess protein. On December 22, 2001, the physician diagnosed Resident No. 2 with azotemia, due to the elevated BUN level. The elevated BUN level could have several causes, including a gastrointestinal ("GI") bleed, dehydration, infections, or excess protein. The physician ordered a stool culture to rule out a GI bleed. The culture tested negative for blood in the stool. The physician ordered further lab work on December 24, 2001. Resident No. 2's BUN level remained at 84 mg/dL. Her creatinine and hematocrit (red blood cell) levels were within normal limits. These labs caused the physician to focus on excess protein as the cause of the elevated BUN level. On December 28, 2001, he ordered a dietary consultation regarding Resident No. 2's protein intake. Staff of IHS did not perform the dietary consultation. Ms. Gathy was on vacation during this period, and no one at IHS informed the consulting dietician on duty, Chrisanna Harrington, that the consultation had been ordered. Resident No. 2 continued to receive the Resource Diabetic feedings at 75 cc/hour. Ms. Harrington performed a nutritional assessment of Resdient No. 2 on January 14, 2002. She documented a significant unplanned weight gain of 6.4 pounds by Resident No. 2, from 99.6 to 106 pounds in one month. She recalculated the resident's caloric and protein needs upward, from 1320 to 1820 calories per day and from 64 to 72 grams of protein per day. Ms. Harrington recommended continuing the Resource Diabetic feedings at 75 cc/hour and otherwise continuing with the existing care plan. When she performed her assessment on January 14, 2002, Ms. Harrington was unaware that the physician had ordered a dietary consult. She was also unaware of the laboratory tests performed the previous December. She did not know that Resident No. 2's BUN levels were elevated. Ms. Harrington only learned of the physician's orders and the lab tests when the agency surveyor, Ms. Lehman, informed her of them on February 4, 2002. Ms. Harrington then performed a weight review of Resident No. 2 that showed her weight increased to 107.2 pounds. She recalculated the residents caloric and protein needs downward to 1400 calories and 57.6 grams of protein. She recommended reducing the tube feeding to 55 cc/hour, and recommended further laboratory testing. The labs performed on February 5, 2002, indicated that Resident No. 2's BUN level was at 71 mg/dL, reduced but still well above normal limits. At the hearing, IHS contended that Resident No. 2's elevated BUN level was not necessarily caused by excessive protein intake. The resident suffered a urinary tract infection in early December. Infections can increase the BUN level. Throughout her stay at IHS, the resident was receiving Prinivil, a beta-blocker for hypertension that has a potential side effect of increasing the BUN level. In October 2001, the resident received Levaquin, an anti-infective drug, that could have influenced her BUN level. The weight of the evidence made it clear that, while these other causes were possibilities, the excessive protein was the most likely cause. The steps taken by the physician showed that he believed excessive protein was the most likely cause of the elevated BUN level, once he ruled out a GI bleed. Ms. Harrington, too, acted immediately to reduce Resident No. 2's protein intake as soon as she was informed of the elevated BUN level. In any event, the cause of the elevated BUN level is less important than the fact that the facility's care ensured that the resident's BUN level would not be tested for a period of three and one-half months. Resident No. 2 was an elderly diabetic with a history of azotemia, and was being provided a diet with a level of protein well in excess of her assessed need, yet no laboratory blood levels were taken between September 5 and December 18, 2001. Even after the attending physician began to suspect excess protein as the culprit and ordered a dietary consultation, the facility failed to act on the order. In summary, the evidence presented at the hearing demonstrated that IHS provided an excessive amount of protein in the tube feeding of this elderly diabetic resident, failed to monitor the resident's laboratory values, including BUN levels, despite a documented history of azotemia, and failed to follow physician orders calling for a dietary consultation. All of these factors placed Resident No. 2 in unnecessary jeopardy of sustaining kidney damage. That she displayed no outward physical signs of kidney damage was fortuitous, not the result of the care provided by IHS. The evidence demonstrated that IHS compromised Resident No. 2's ability to maintain or reach her highest practicable physical, mental, and psychosocial well-being as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration enter a final order upholding its notice of intent to assign conditional licensure status to Integrated Health Services of Port Charlotte. DONE AND ENTERED this 10th day of October, 2002, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON 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 10th day of October, 2002. COPIES FURNISHED: Jonathan S. Grout, Esquire Goldsmith & Grout, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Suite 310-G St. Petersburg, Florida 33701 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue The issue in this case is whether Respondent, Charles R. Thompson, M.D., failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances as alleged in an Administrative Complaint entered November 3, 1993.
Findings Of Fact The Parties. Petitioner, the Agency for Health Care Administration (hereinafter referred to as the "Agency"), is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.165, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. (Stipulated Fact). Respondent, Charles R. Thompson, M.D., is, and has been at all times material hereto, a licensed physician in the State of Florida. Dr. Thompson was issued license number ME 0053590. Dr. Thompson's last known address is 8333 North Davis Highway, Pensacola, Florida 32514. (Stipulated Facts). Dr. Thompson specializes in internal medicine. Dr. Thompson is not, however, Board certified in internal medicine. (Stipulated Facts). At all times relevant to this proceeding, Dr. Thompson was a shareholder/employee of the Hodnette Medical Center Clinic, a/k/a The Medical Center Clinic, P.A. (hereinafter referred to as the Medical Center Clinic"), in Pensacola, Florida. Dr. Thompson has not been the subject of any disciplinary action against his license to practice medicine, other than the subject proceeding, and has had no medical malpractice claims asserted against him. Patient Number 1, K. M.. Patient Number 1, K. M., was a 27 year old female. (Stipulated Fact). K. M. had a history of severe insulin dependent diabetes mellitus, severe hypertension, blindness due to diabetic retinopathy, and chronic renal failure. K. M. had lost a toe due to gangrene. (Stipulated Facts). She suffered from fluctuating blood sugars, recurring problems with headaches, recurring problems with nausea and vomiting, recurring instances of non- compliance with physicians' orders, recurring episodes or phases of anemia and recurring periods during which she suffered from diabetic ketoacidosis. K. M. was also suspected of suffering from coronary artery disease, due to the severity and duration of her diabetes and the resulting peripheeral vascular disease. She was also suspected to suffer from diabetic gastroparesis, a condition that affects the function of the stomach and digestive tract. Dr. Thompson had become K. M.'s primary treating physician around October of 1989. She had been a patient at the Medical Center Clinic prior to becoming Dr. Thompson's patient. Emergency Room Visits Prior to September, 1990. During the year 1990, K. M. went to the Emergency Department of West Florida Regional Medical Center (hereinafter referred to as "West Florida Regional"), on eight different occasions prior to September 16, 1990. On some of the 1990 Emergency Department visits, K. M. presented with symptoms similar to those which she presented with at the time of the hospitalization which is the subject of this proceeding. The symptoms she presented with included headaches, nausea and vomiting, hypertension and manifestations of kidney dysfunction. Dr. Thompson was consulted on three of these occasions. K. M. was hospitalized from July 9, 1990 through July 19, 1990. She was under the care of Dr. Thompson during this hospitalization. K. M. was treated for insulin dependent mellitus, nausea and vomiting secondary to probable gastroparesis, hypertension, dehydratin and anemia. During K. M.'s July, 1990, hospitalization, she received IV fluids, blood pressure medications, and medication to treat nausea and vomiting and the effects of diabetic gastroparesis. She was discharged in stable condition on July 19, 1990. K. M.'s Hospitalization in September of 1990. On or about September 16, 1990, K. M. presented to the Emergency Department of West Florida Regional with complaints of headache, nausea and uncontrolled vomiting. K. M. was vomiting blood. (Stipulated Facts). Dr. Thompson, K. M.'s primary care physician, was consulted by the Emergency Department physician. Dr. Thompson examined K. M. and noted that she was dehydrated with no diarrhea or edema, had clear lungs and a regular heart rate and rhythm. K. M. had a blood pressure of 218/137. (Stipulated Facts). Dr. Thompson diagnosed K. M. with dehydration, nausea, probably due to chronic renal failure, and possible tear ("Mallory-Weis") to the esophagus due to severe vomiting. (Stipulated Facts). Dr. Thompson's assessment also included the following findings: (a) insulin-dependent diabetes mellitus; (b) hypertension; (c) chronic renal failure secondary to diabetic nephropathy; (d) migraine headaches; (e) mild diabetic ketoacidosis; (f) anemia; (g) poorly controlled blood sugars; and (h) tachycardia. At the time of her admission to West Florida Regional, K. M. was critically ill. A component of K. M.'s illness was her volume status. Dr. Thompson admitted K. M. to the Critical Care Unit (hereinafter referred to as the "CCU"), of West Florida Regional, administered Catapres intravenously to lower her blood pressure, and issued orders for intravenous rehydration and insulin therapy. (Stipulated Facts). Dr. Thompson also ordered Bicitra for K. M.'s acidosis. Dr. Thompson's full admitting orders are recited in Respondent's proposed finding of fact 8. The protocol for the CCU included orders for the contemporaneous recording of all intake and output of a patient receiving IV fluids, such as K. M. The protocol also included orders for the taking of vital signs, including pulse, respiration and blood pressure on a frequent and regular basis. The protocol orders were followed for K. M. K. M. was admitted to the CCU by Dr. Thompson because he believed she would receive more constant nursing supervision and attention than on the regular hospital floor. There was one nurse to every one or two patients on the CCU, a much higher nurse staffing ration than on the regular floor. On September 17, 1990, Dr. Thompson's physical examination of K. M. revealed that her nausea persisted with some vomiting. The bleeding, however, had decreased. Dr. Thompson's medical records reflect that K. M. refused an upper endoscopy to determine the cause of the bleeding. K. M. also declined Dr. Thompson's suggestion that she could benefit from a blood transfusion. Dr. Thompson also noted no edema. (Stipulated Facts). At 3:00 p.m., on September 17, 1990, Dr. Thompson ordered Demerol, 25 mg IM or IV every four hours PRN for pain. At 5:55 p.m. Dr. Thompson ordered 14 units of insulin, SQ stat. Dr. Thompson later ordered the following: Please begin clear liquids - ADA SMA-7, CBC in AM MG SO4 8 mg IV over 6 hrs (in N/S) Notify Dr. Wayne Miller of admit & location Stools for blood, X 3 Bicitra 15 cc po BID On September 18, 1990, Dr. Thompson examined K. M. Dr. Thompson found the following: Continues with nausea, vomiting. Some coffee-ground material. Afebrile, Vital Signs Stable. Exam--unchanged. Blood sugars fluctuating 35-400. Hematocrit down to 22.4 last p.m., 23 this a.m. Patient refuses transfusion and endoscopy. Will continue to monitor H & H and B.S. If Hematocrit continues to fall, will have to convince to have transfusion and endoscopy. Based upon Dr. Thompson's examination of K. M. on September 18, 1990, he ordered: (a) Hematocrit and hemoglobin be changed every 8 hours, instead of every 12 hours--call if Hematrocirt goes below 22; and (b) SMA-7, CBC in a.m. On or about September 19, 1990, Dr. Thompson examined K. M. and noted 1+ edema in the hands and feet. Edema is swelling and is an indication that a person is retaining excessive fluids. Dr. Thompson ordered 20 mg. of Lasix, a diuretic, and reduced K. M.'s fluid intake. According to Dr. Thompson's records he also found no S3 Gallup and that her lungs were clear. (Stipulated Facts). Dr. Thompson's observations of the results of his examination of September 19, 1990, were as follows: Patient confused yesterday and this a.m. Still with some dry heaves. Afebrile--vital signs stable. Lungs: clear CV: regular rate and rhythm without S3 gallop Abdomen: positive bowel signs, no increased organomegaly Extremities: 1+ edema feet and hands Intate/Output markedly positive Hematocrit 24.6 this a.m. Blood Sugars 100-250 Plan: Will transfer to floor--watch blood sugars and Hematocrit and Hemoglobin-- as long as stable Hematocrit and Hemoglobin, will try to hold on Endoscopy, but if nausea, gagging continue, will need to look at stomach. Give Lasix and decrease IV fluids. Check labs in a.m. Dr. Thompson ordered the following: Please transfer to floor, no monitor needed. Decrease Hematocrit and Hemoglobin checks to every 12 hours. SMA-18, CBC in a.m. Lasix 20 mg IV now. Decrease IV fluids to 100 CCs per hour [down from 150]. Decrease Zantac to 50 mg IV. After Dr. Thompson examined K. M. on September 19, 1990, he visited briefly with her parents. Dr. Thompson then checked out of the hospital and went home because he was ill. Pursuant to protocol, another physician was to cover for Dr. Thompson. On or about September 19, 1990, K. M. suffered cardiac arrest and revived. K. M. expired after multiple episodes of cardiac arrest. (Stipulated Facts). K. M. first sustained an acute myocardial infarction at approximately 3:00 p.m. This was the first time that K. M. first evidenced shortness of breath. Three separate Code 3 procedures were administered to K. M. During the Code 3 procedures she received additional fluids. The autopsy report on K. M. dated September 20, 1990 indicates that K. M. suffered from acture bilateral bronchopneumonia of the lower lobes with severe pulmonary edema and bilateral pleural effusions, severe artherosclerosis, and marked abdominal ascites. The cause of K. M.'s death was an acute myocardial infarction. (Stipulated Facts). To the extent that K. M. experienced a fluid overload, that condition did not cause the myocardial infarction she suffered. Fluid overload had nothing to do with the myocardial infarction. E. Monitoring K. M.'s Fluids. K. M.'s condition required that her fluids be monitored. K. M. was receiving rehydration therapy. She was also receiving medication to control her hypertension. These are opposing therapies and, therefore, more strict monitoring was required. While K. M. was dehydrated and needed fluids, the condition of her kidneys caused her to be less able to handle fluids. It is preferrable, however, that a patient such as K. M. experience some fluid overload as opposed to being dehydrated. Nonetheless, if a patient receives and retains excessive fluids it can be detrimental to the patient. For example, a patient that receives and retains excessive fluids may develop pulmonary edema. Dr. Thompson monitored K. M.'s rehydration progress through "gross methods". Dr. Thompson used physical examination, including listening to K. M.'s heart and lungs with a stethescope and physically and visually checking for swelling or the absence thereof. K. M.'s fluid intake and output was also recorded and reviewed by Dr. Thompson. K. M.'s intake and output of fluids was monitored and recorded on a continuing basis each day that she was hospitalized, consistent with protocols. Fluid intake was recorded by IV fluid, IV medication and oral consumption. Fluid output was recorded as urine, bowel movements and emesis. Measuring fluid intake and output is not completely accurate. Dr. Thompson monitored K. M.'s intake and output, he examined K. M. daily, he looked for pulmonary or cardiac signs of fluid overload, he reviewed nurses notes, graphic sheets recording pulse rate, respiration and blood pressure, and reviewed lab results. These items did not suggest that K. M. was experiencing fluid overload. Dr. Thompson was alert for any signs of edema. There was, in fact, no sign of edema until the morning of September 19, 1990, and Dr. Thompson took steps to alleviate what he concluded was mild edema. Until that time, K. had not evidenced any shortness of breath, which would have suggested pulmonary edema and a possible fluid overload. Dr. Thompson did not order the use of a Swan-Ganz catheter or a central venous line. These are both invasive devices designed to measure fluids. Dr. Thompson also did not order daily weighing of K. M. Weighing a patient can provide information about fluids levels by monitoring weight gain. Dr. Thompson also did not order daily x-rays of K. M.'s lungs to determine if she had fluid in her lungs. Dr. Thompson relied on listening to her lungs with a stethoscope. K. M. Experienced Excessive Fluids. K. M. experienced excessive fluids, or a "fluid overload", while under Dr. Thompson's care. The terms "fluid overload" refer to the condition of the body when excessive fluids are retained in the body. While hospitalized, K. M. received approximately 8,120 cc.'s of fluid in excess of what her intake and output measurements indicated she was excreting. On the second day of her hospitalization, K. M. received three times the amount of fluids she excreted. On the morning of September 19, 1990, a nurse caring for K. M. telephoned Dr. Thompson and expressed concern to Dr. Thompson over the amount of fluids K. M. was receiving. It was after this telephone call that Dr. Thompson noted K. M.'s edema and ordered a reduction in her fluids and that she be given Lasix, a diuretic. Although K. M. did not have any signs of fluid overload until the morning of September 19, 1990, the results of her autopsy indicate that she had begun suffering a fluid overload one or two days earlier. The autopsy also revealed that K. M. had bilateral pneumonia. This condition was not detected by Dr. Thompson during his clinical assessment of her. Did Dr. Thompson Fail to Adequately Monitor K. M.'s Fluid Level? The evidence failed to prove that there is a single, standard method of monitoring the fluid status of a patient such as K. M. The physicians called as witnesses by the Agency all agreed that Dr. Thompson failed to adequately monitor K. M.'s fluid levels. All three physicians disagreed, however, about the method of monitoring that should have been employed. The physicians called as witnesses by Dr. Thompson all agreed that Dr. Thompson's efforts to monitor K. M.'s fluid levels were adequate. The explanations provided by the Agency's witnesses of their opinions as to Dr. Thompson's treatment were inadequate to support a finding that the opinions as to Dr. Thompson's treatment provided by Dr. Thompson and his witnesses were inaccurate. The weight of the evidence failed to prove that Dr. Thompson deviated from the appropriate standard of care by failing to adequately monitor K. M.'s condition. The weight of the evidence failed to prove that Dr. Thompson failed to practice medicine with an acceptable level of care, skill, and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions.
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 all charges in the Administrative Complaint entered against Charles R. Thompson, M.D. DONE and ENTERED this 1st day of July, 1996, in Tallahassee Florida. LARRY J. SARTIN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of July, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-6437 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Agency's Proposed Findings of Fact Accepted in 2. Accepted in 3. Accepted in 6-7. Accepted in 14. Accepted din 14-15 and 18. See 16 and 19. Hereby accepted. Accepted in 8. 9-10 Accepted in 18. Accepted in 32. Hereby accepted. Accepted in 34-36. Accepted in 35. 15-16 Not supported by the weight of the evidence. 17 Accepted in 33. 18-19 Accepted in 32. Hereby accepted. Not supported by the weight of the evidence. See 26. Accepted in 27. Hereby accepted. See 20. 26-27 Not supported by the weight of the evidence. 28 Accepted in 40. 29-30 Accepted in 41. The last sentence of proposed finding of fact 30 is not supported by the weight of the evidence. 31 See 42. 32-33 Accepted in 25. 34 See 25 and 42-43. Accepted in 25 and 27. See 27 and hereby accepted. Accepted in 29. Not supported by the weight of the evidence. Accepted in 30 and 43. Accepted in 32. Accepted in 26. 42-43 Accepted in 43. 44-50 Not supported by the weight of the evidence. Dr. Thompson's Proposed Findings of Fact Accepted in 2-4 and hereby accepted. Accepted in 9. Accepted in 7-8. Accepted in 10-11 and hereby accepted. Accepted in 12-13 and hereby accepted. Accepted in 14-16 and 18. Accepted in 17. Accepted in 19 and hereby accepted. Accepted in 21 and hereby accepted. 10-11 Accepted in 21. Accepted in 22. Accepted in 23. Accepted in 24. Accepted in 26 and hereby accepted. Accepted in 27. Although generally correct, this charge was dismissed by Petitioner. Accepted in 35 and hereby accepted. Accepted in 28 and hereby accepted. Accepted in 29 and hereby accepted. Accepted in 30. Statement of the issues. Paragraph 22(a) was dismissed by Petitioner. Hereby accepted. Accepted in 35. See 34-36. Restatement of previously proposed findings. Accepted in 37-39. See 44-49. These proposed findings constitute an accurate summary of testimony. See 45-49. These proposed findings constitute an accurate summary of testimony. 29-30 These proposed findings constitute an accurate summary of testimony. See 45-49. These proposed findings constitute an accurate summary of testimony. These proposed findings constitute an accurate summary of testimony. 33-34 These proposed findings are generally correct but are irrelevant. 35-36 These proposed findings constitute an accurate summary of testimony. See 45-49. These proposed findings constitute an accurate summary of testimony. These proposed findings constitute an accurate summary of testimony and argument. These proposed findings are a repeat of previous proposed findings. Hereby accepted. Accepted in 36. These proposed findings are a repeat of previous proposed findings. Hereby accepted. 44 See 45-49. COPIES FURNISHED: Britt Thomas, Esquire Agency for Health Care Administration Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 James M. Wilson, Esquire 307 Palafox Street Pensacola, Florida 32501 Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Douglass M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman, Esquire 2727 Mahan Drive Tallahassee, Florida 32309
The Issue Whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2000), and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes (2003), and Chapters 456 and 458, Florida Statutes (2003). Dr. Dunn was issued license number ME 37819 in 1981 and is board certified in internal medicine and oncology. At all material times to this proceeding, Dr. Dunn was a licensed medical physician in the State of Florida. Prior to this case, Dr. Dunn has never been the subject of disciplinary action regarding his license to practice medicine in Florida. B.P. became Dr. Dunn's patient in 1984, when she was diagnosed with a tumor at the base of her tongue. The tumor was a malignant, large cell lymphoma. Dr. Dunn treated her with radiation and chemotherapy, and the lymphoma disappeared. Dr. Dunn monitored her for seven years, and B.P. did well until 1991, when nodules were discovered on the sides of her neck, underneath her arm, and in her groin area. She was diagnosed with diffuse mixed lymphoma. At the time she was diagnosed with lymphoma, she had asthmatic bronchitis and was under the care of pulmonary physicians. B.P. again received chemotherapy, but the results were not as positive as they were with her earlier bout of lymphoma. She was switched to an oral chemotherapy, which she took until 1993 when she began a remission. Her remission lasted until 1998, when she was diagnosed with lymphoma in her blood and bone marrow. Another course of chemotherapy was begun. However, the chemotherapy did not completely cure the lymphoma, and B.P. had problems with low blood counts and intermittent reappearances of the lymphoma cells in her blood. From 1998 to 2000, B.P. also suffered chronic respiratory problems with asthmatic bronchitis and fibrosis in the lungs. In July 2000, B.P. was diagnosed with proptosis, which meant that her eye was bulging out of the eye socket. The lymphoma had reoccurred, and a mass of lymphoma cells were behind the eye pushing the eyeball forward. Dr. Dunn attempted to treat B.P. with radiation therapy, but B.P. could not complete the radiation therapy because her blood counts were too low, and her bone marrow was malfunctioning. B.P.'s white blood count steadily decreased, and she was not producing red blood cells. On August 17, 2000, Dr. Dunn saw B.P. in his office and ordered a blood transfusion to increase her blood counts. On August 25, 2000, B.P. was hospitalized in Orlando Regional Medical Center (ORMC) for a fever and a low white blood count. She was given antibiotics and blood transfusions. After she was released from the hospital, Dr. Dunn continued to see her in his office to monitor her blood counts. On October 3, 2000, B.P. came to Dr. Dunn's office. She appeared very ill and frail and was confined to a wheelchair. B.P.'s prognosis was very poor. Her breathing was problematic; her bone marrow was overrun with lymphoma; the mass behind her eye was causing the eye to bulge; and she was unable to tolerate either radiation therapy or chemotherapy. There was very little that could be done for B.P.'s condition other than to try measures to keep her comfortable. At the time of the October 3 office visit, B.P.'s blood counts were low. Dr. Dunn ordered a transfusion for B.P. in an attempt to raise her hemoglobin count above ten so that her oxygen-carrying capacity would be optimal. There was little that could be done for the low platelet and white cell counts. The transfusion was to be performed at ORMC, where B.P. had most of her care done. ORMC did not have any beds available so B.P. was sent to Sand Lake Hospital to have the transfusion done on an outpatient basis. When B.P. went to Sand Lake Hospital, an Interdisciplinary Patient Care Flowsheet was completed, indicating that B.P. could communicate pain and that she was not having any pain. Originally it was not anticipated that the transfusion would require an overnight stay. However, because of the hour when the transfusion would be completed, the nurses requested that B.P. be allowed to stay overnight. The transfusion was completed around 1:20 a.m. on October 4, 2000. At approximately 5 a.m., B.P. attempted to go to the bathroom alone and fell. She sustained a bruise to the head approximately five-by-four centimeters in size. There was a reddened area on her left temple and a laceration to the left internal cheek. There were no other external injuries. Ice was applied to B.P.'s head, and her mouth was rinsed with water. At 5:45 a.m., a nurse called Dr. Dunn's answering service to advise of B.P.'s condition and that B.P. had fallen. The evidence does not establish that the answering service called Dr. Dunn at his home. At 8:00 a.m., a nurse called Dr. Dunn's office concerning B.P. Dr. Zehngebot, Dr. Dunn's partner, returned the telephone call. The nurse advised Dr. Zehngebot that B.P. had been found on the floor where she had fallen around 5 a.m. and that B.P. had sustained a quarter-sized bruise to her left forehead. Dr. Zehngebot was told that the patient was not in distress and that she was alert and oriented times three. Dr. Zehngebot ordered a complete blood count (CBC) to determine B.P.'s blood count level. The nurse was told to call Dr. Dunn if the results of the CBC were abnormal. According to Dr. Zehngebot's telephone order, B.P. was to be discharged on that day and was to follow-up with Dr. Dunn in one week. At 8 a.m., another Interdisciplinary Patient Care Flowsheet was completed for B.P. It was noted on the form that B.P. had a purple, quarter-sized bruise on her left forehead and a bruise on her right upper chest area. It was noted that the doctor was aware of these bruises. Based on the timing of the telephone conversation between the nurse and Dr. Zehngebot, the completion of the Interdisciplinary Patient Care Flowsheet and the nurse's notes, it can be inferred that the doctor referenced on the 8 a.m. Interdisciplinary Patient Care Flowsheet as having been advised of the bruises on B.P. was Dr. Zehngebot and not Dr. Dunn. It was also noted on the Interdisciplinary Patient Care Flowsheet completed at 8 a.m. that B.P. was having intermittent headaches. Nothing in the record indicates that either Dr. Zehngebot or Dr. Dunn was ever advised that B.P. was having headaches after her fall. The CBC was done, and the results were abnormal. The white count was 1100 and the platelet count was 6000. The normal platelet count range is from 145,000 to 355,000. A nurse telephoned the results to Dr. Zehngebot at 9:50 a.m. At 10:30 a.m., another call was placed to Dr. Zehngebot to get a response to the lab work which had been performed. A message was left with the doctor's nurse. By 12:30 p.m., the nurse at Sand Lake Hospital had not received a response from either Dr. Zehngebot or Dr. Dunn; thus, another call was placed to Dr. Dunn's office. A message was left with a nurse in Dr. Dunn's office that B.P.'s husband was at the hospital to pick up his wife and that they were still waiting for an answer from the doctor's office. At 2 p.m., Dr. Dunn returned the telephone 12:30 p.m. call from the hospital. He was aware of the laboratory results. Although, the white cell count and the platelet count were similar to what they had been in his office on October 3, the hemoglobin count was up to 10.9; thus, Dr. Dunn felt that the transfusion had accomplished its purpose by raising the hemoglobin count above ten. The nurse gave him a patient status update and advised him that B.P. was alert and oriented times three and that her vital signs were stable. Dr. Dunn was aware at the time of his two o'clock telephone call that B.P. had fallen; however, the record does not clearly establish that Dr. Dunn knew that B.P. had sustained bruises to her head as a result of the fall or that B.P. had headaches after her fall. He did not order a neurological consult nor did he go to the hospital to examine B.P. before he gave the order to discharge B.P. at 2:00 p.m. Normally a physician may not come to the hospital to examine a patient while the patient is at the hospital to receive a transfusion on an out-patient basis. Dr. Dunn did not see B.P. from the time she went to Sand Lake Hospital on October 3, 2000, and the time he discharged her on October 4, 2000. On October 6, 2000, Dr. Dunn received a telephone call from B.P.'s husband, who told Dr. Dunn that B.P. had slipped and fallen on the way to the bathroom and was now having headaches and nausea. Dr. Dunn told the husband to take B.P. to the emergency room at ORMC, called the hospital, and ordered a stat CT scan to be done as soon as B.P. arrived at the hospital. Dr. Dunn went to the hospital to see B.P. B.P. was diagnosed with Traumatic Subdural Hematoma, admitted to ORMC, and referred to a neurosurgeon who, on October 16, 2000, performed an evacuation of the hematoma. B.P. died on October 22, 2000. The Department called Dr. Howard R. Abel as its expert witness. Dr. Abel opined that Dr. Dunn fell below the standard of care because he did not go to the hospital and evaluate B.P., or if Dr. Dunn could not go to the hospital, he did not request a neurological consultation. Dr. Abel's opinion is premised on the assumption that Dr. Dunn was aware that B.P. had sustained head trauma when she fell. Dr. Abel further opined that if Dr. Dunn were not aware that B.P. had suffered a head trauma, Dr. Dunn did not fall below the standard of care by not going to the hospital or ordering a neurological consultation.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Philip Herbert Dunn, M.D., did not violate Subsection 458.331(1)(t), Florida Statutes (2000), and dismissing the Administrative Complaint. DONE AND ENTERED this 20th day of April, 2004, in Tallahassee, Leon County, Florida. S SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of April, 2004. COPIES FURNISHED: Irving Levine, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Post Office Box 2753 Orlando, Florida 32802-2753 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether the Board of Medicine should take disciplinary action against respondent for the reasons alleged in the administrative complaint?
Findings Of Fact Josefino P. Bargas holds license No. ME 0029440. He has been a licensed physician in Florida at all pertinent times, engaging in the general practice of medicine in central Florida. Internal Bleeding On October 25, 1984, Dr. Bargas admitted then 67-year old Mr. H.S. to Florida Hospital in Apopka. When the patient reached a medical floor at 3:40 that afternoon, Dr. Bargas assumed responsibility for H.S.'s care, taking over from staff in the emergency room, where H.S. had appeared that morning at 11:25. By 4:30 on the afternoon of October 25, 1984, H.S.'s pulse rate had fallen to 77. In the emergency room, Dr. Murphy had ordered "1,000 cc's of D5, half normal saline started with a 200 angio cath in the right wrist with a three-way stopcock ... [which one of petitioner's experts assumed] was in anticipation of giving him blood." T.102. Emergency room staff carried these orders out. The saline solution (with dextrose) was administered in response to apparent dehydration. An apparatus with a larger bore is ordinarily used for blood transfusions. When he arrived at the hospital, H.S. complained of melena and reported a history of ulcers. He had been taking Tagamet for epigastric pain. His pallor, his pulse rate of 104, his hemoglobin of 11.2 grams per liter and his hematocrit of 34% all pointed to decreased blood volume, reduced hemoglobin, and significant bleeding. Dr. Bargas ordered hemoglobin and hematocrit assessments once daily, and a single prothrombin time test, the results of which demonstrated that H.S.'s blood took longer than normal to clot, possibly a side effect of Tagamet. Nurses' notes reflected that stools H.S. passed after he was admitted contained blood. One was the subject of a laboratory test Dr. Bargas ordered to determine blood content; the result was 4+, the maximum indication. On October 26, 1984, Dr. Bargas wrote, on H.S.'s chart, "Bleeding still present?" Nothing about H.S.'s pulse, respiration, blood pressure nor anything in his demeanor indicated significant additional blood loss, although he complained of dizziness when he stood. The same day Dr. Bargas entered written orders, including "DC IV fluids," which signified, "Discontinue intravenous fluids." At two o'clock on the afternoon on the 26th, a nurse discontinued fluids and removed the apparatus through which they had entered H.S.'s vein. Dr. Bargas did not order another to replace it. Unless otherwise specified, a doctor's orders to discontinue intravenous fluids may be construed as a directive to discontinue intravenous access, which can be a conduit for infection. But Geraldine Petrone, for 13 years Director of Nursing at Williston Memorial Hospital, would not remove intravenous access without inquiry of the physician, if she saw "DC IV fluids" in a patient's chart. By 4:35 on the afternoon of October 26, 1984, the laboratory had reported to the floor that day's test results, including a hemoglobin of 7.2 grams per liter. But this had not been charted when Dr. Bargas made rounds at 85 that evening, and he did not inquire as to the laboratory results. The hospital laboratory is open 24 hours a day on an "on call" basis. Customarily, staff acts affirmatively to bring test results as significant as these to the attention of the treating physician. Before Dr. Bargas' arrival the following morning at 10:30, the nursing staff also learned the October 27 blood test results. Alarmed particularly at one of them, a hemoglobin of 5.5 grams per liter, and unable to reach Dr. Bargas, a conscientious nurse told the chief of staff about the situation. He ordered that four liters of blood be "typed and cross-matched," and that H.S. be given two units of blood. Only after Dr. Bargas arrived, however, did the transfusion begin. The drop in hemoglobin from 11.2 to 5.5 grams per liter reflected a loss of at least half the volume of H.S.'s blood, a "potential crisis situation." T. 87. Because hemoglobin measurements are "always behind in a patient that is bleeding," (T.87) hemoglobin and hematocrit testing only at 24- hour intervals is not adequate. When a patient is bleeding internally, minimum acceptable practice requires monitoring at intervals of "[s]ix hours at the outside, probably four," id., unless significant bleeding is known to have stopped. It would also have been better practice to order blood-typing, cross- matching, and intravenous access as precautionary measures or, as regards access, at least to have held off on ordering discontinuance of the access already in place (notwithstanding its straitness.) If evidence exists that a patient is actively bleeding, cross-matching should be done right away. T. 176. Physicians order blood typed and cross-matched as a precaution, in case an emergency transfusion proves necessary, even though blood that is not used must be wasted. "[P]eople can go into shock at any time." Reddy Deposition, p.11. Typing and cross-matching take about a half hour. Sometimes veins collapse before access is established, making it impossible to accomplish a transfusion, although such venal collapse is extremely rare. Reddy Deposition. Diabetes with Infection On October 26, 1984, Dr. Bargas admitted Mr. A.S., 51 years old at the time and disabled, to Florida Hospital. In the history he took on admission, Dr. Bargas noted that A.S. was taking "NPH insulin 25 units," Petitioner's Exhibit No. 4, twice daily. Although A.S. may have begun this regimen only a week or two before admission, he had taken insulin orally for a period of years, and was "an insulin-dependent diabetic." Londono Deposition, p.14; McClelland Deposition, p.13. "He obviously was a pretty sick type of individual. He was dehydrated. He was febrile. He was nauseous. He was vomiting. And he had what seemed to be a rotten foot." Id., p.11. Septicemia, a blood borne infection apparently attributable to A.S.'s infected, ulcerated right leg, was among A.S.'s medical problems Dr. Bargas recognized on his admission to hospital. "With high blood sugars, there can be problems with white blood cell response to infection." McClelland Deposition, p.9. Insulin makes glucose in the blood available for use by cells, normalizing blood levels. When he entered the hospital, A.S.'s blood sugar level was elevated. Blood sugar levels at "a controlled diabetes level" range between 60 or 70 and 120 or 200 milligrams per milliliter. Londono deposition, p.12. An elevated blood sugar level is not critical or life-threatening in itself, unless it exceeds 500 milligrams per milliliter. Id., pp.11, 12. N.P.H. insulin "lasts" 24 to 36 hours, but regular insulin has a half-life of less than 30 minutes. Blood glucose levels oscillate in response to regular insulin, in no less than two to three hours, and, in response to "long acting insulin anywhere between 8 and 24 hours." Londono Deposition, p.21. On A.S.'s admission, Dr. Bargas ordered urinalysis and a blood sugar test "stat." He prescribed regular insulin, depending on the urinalysis results. Dr. Bargas wrote: Rx urine for sugar & acetone and give regular insulin accordingly 4+ 20 units 3+ 15 2+ 10 1+ 0 Petitioner's Exhibit No. 4, p.123A. Because blood tests for glucose levels are much more precise than urine tests, which only approximate blood glucose levels, Dr. Bargas' prescription for "insulin ... on a sliding scale for urine," Londono Deposition, p.15, left something to be desired. Dr. Bargas ordered urine tests for sugar and acetone four times a day, and blood tests, which are more expensive, once daily. As with A.S., a patient may be unable to void on schedule. Urine collects in the bladder over time; accordingly, urine test results for glucose reflect an average, which may be misleading. The volume of blood moving through the kidney affects the concentration of glucose in the urine. Renal thresholds (the levels at which glucose leaves the blood to enter the urine) vary among individuals. The correlation between glucose levels in blood and urine is particularly problematic when a diabetic is acutely ill. Infection can cause elevated blood glucose levels, and affect kidney function. Test results known to Dr. Bargas indicated A.S. had impaired kidney function. At four o'clock on the afternoon of the 26th, the "clinitest" for sugar in A.S.'s urine yielded a result of "3+." A.S. received 15 units of regular insulin an hour and a half later. A contemporaneous blood test indicated 398 milligrams of glucose per milliliter of blood. At seven o'clock (or half past) on the evening of October 26, 1984, A.S. received a second dose of 15 units of regular insulin. T.48; Petitioner's Exhibit No. 4, p.220. Between six and seven the following morning and again at ten, A.S. was unable to produce a urine specimen. A blood test on a sample taken at ten o'clock indicated 264 milligrams of sugar per milliliter of blood. Tests on urine samples taken later on the 27th, at half past noon, at five o'clock and at seven o'clock yielded "+1." In keeping with Dr. Bargas orders, no insulin was administered to A.S. that day. A blood sample taken at quarter past two on the morning of October 28, 1984, in conformity with Dr. Bargas' order to test "stat.," indicated 399 milligrams of sugar per milliliter of A.S.'s blood. The laboratory apprised Dr. Bargas of these results. At 4:30 on the morning of the 28th, a urine test yielded a "3+." Three hours later A.S. received 15 units of regular insulin, his first insulin in some 36 hours. At no time did test results reflect ketosis. Even for general practitioners in Apopka in 1984, the failure to order more frequent blood sugar tests, and insulin coverage as indicated by such tests, for an insulin-dependent diabetic suffering from septicemia and a foot infection fell below minimum levels of acceptable practice. Dr. Bargas' approach, although once very common, was "antiquated" even than. His use of regular insulin, rather than N.P.H. insulin was appropriate. But allowing 36 hours to elapse between doses of regular insulin, and failing to order insulin promptly on learning the results of the tests the morning of the 28th, fell below standards.
Recommendation It is, accordingly, in consonance with Rule 21M-20.001(t) Florida Administrative Code, RECOMMENDED: That the Board of Medicine suspend Josefino P. Bargas license to practice medicine for sixty (60) days, and thereafter until he has completed at least three (3) days instruction on the management of diabetes, and paid a one thousand dollar ($1,000) fine; and that, once his license is reinstated, he be placed on probation for a year, on condition that a representative of the Board of Medicine review a sample of his charts monthly to determine that they demonstrate that he is practicing at least minimally acceptable medicine. DONE AND ENTERED this 24th day of May, 1989, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of May, 1989. APPENDIX Petitioner's proposed findings of fact Nos. 1 through 6, 8 through 14, 16 through 30, 37, 40, 45, 46, 50, 51, 53 through 57, 63, 65, 69, 73, and 74 have been adopted, in substance, insofar as material. With respect to petitioner's proposed finding of fact No. 7, the test were done after admission. With respect to petitioner's proposed finding of fact No. 15, Dr. McBride ordered that two units be administered. Petitioner's proposed findings of fact Nos. 31, 32, 33, 38, 39, 47, 48, 58, 59, 60, 61, 62, 64, 66, 71 and 72 relate to subordinate matters. Petitioner's proposed findings of fact Nos. 34, 35, 36, 41, 42, 43, 44, 49 and 52 accurately recite the substance of the witnesses' testimony they report. With respect to petitioner's proposed finding of fact No. 68 the test results were not charted when he was at the hospital that evening. With response to petitioner's proposed finding of fact No. 70, he testified that he did not even believe he might be bleeding. With response to petitioner's proposed finding of fact No. 75, Dr. Bargas' testimony did raise resal questions of this kind. Respondent's proposed findings of fact Nos. 4, 5, 7, 8, 12, 14, 15, 18, 19, 20 have been adopted, in substance, insofar as material. Respondent's proposed findings of fact Nos. 1, 3, 6, 11, 16, 17 and 22 have been rejected, as unsupported by the weight of the evidence. With respect to respondent's proposed finding of fact No. 2, H.S. was not stabilized and his wishes, which were not proven, are not determinative. With respect to respondent's proposed finding of fact No. 9, clinical observations here included bloody stools and indicated more frequent testing. With respect to respondent's proposed finding of fact No. 13, whatever Dr. Reddy would have done, minimum standards were not met. With respect to respondent's proposed finding of fact No. 21, a preponderance of the evidence established, although not clearly and convincingly, that failure to order more frequent blood test fell below standards. COPIES FURNISHED: Robert L. Hessman Rumberger, Kirk, Caldwell, Cabaniss, Burke & Wechsler, P. A. 101 North Monroe Street, Suite 900 Tallahassee, Florida 32301 Stephanie A. Daniel 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0729 Peter Langley, III Post Office Box 486 Bronson, Florida 32621 Dorothy Faircloth, Executive Director Board of Medicine, Department of Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0729 =================================================================
Findings Of Fact Surindar S. Bedi, Respondent, is licensed as a medical doctor by the Florida Board of Medical Examiners and was so licensed at all times here relevant. He is board certified in family practice and has offices in Zephyrhills and Elfers, Florida. The charges involving six of the complaining witnesses arose following either a local health fair or open house (when Respondent opened his new office) at which these witnesses had a free EKG strip taken. At the health fair Respondent had set up facilities to take strip EKG's of persons so desiring them at no cost. Those given the EKG filled out a release form on which they gave name, address, age, phone number, date of birth, weight, height, whether they had high blood pressure, heart condition, stroke or diabetes, and medications they were taking. They were told that they would be notified by phone if any abnormalities were disclosed in the EKG and by letter if the EKG was normal. John Morris was 74 years old when he and his wife visited the health fair at Gulf View Mall in Port Richey July 23, 1982. At that time Mrs. Morris thought the health fair was sponsored by the county medical association and suggested to John Morris that he take the EKG offered, which he did. In the release form the heart condition, stroke, and diabetes boxes were checked yes, and under medications were listed Pronestyl, Quinidex, Isordil, Digitalis, and Procane (Exhibit 7). In March, 1976, Morris had a massive heart attack, a stroke in 1977, and was in intensive care for 43 days in 1979 with another coronary accident. Prior to the hearing, Mr. Morris has had three cardiac arrests and three strokes or near-strokes. As a result Mrs. Morris had been exposed to cardiovascular illness for several years and, as an intelligent lady, has acquired considerable knowledge of the subject. Approximately one week after the strip EKG was taken at the mall, Mrs. Morris received a telephone call from a female referring to the EKG strip taken at the mall and telling Mrs. Morris that the EKG showed irregularities and that Mr. Morris should have a full EKG taken immediately. This call was received Friday afternoon around 3:00 p.m. Mrs. Morris offered to bring her husband down immediately for the EKG but was told it was not necessary because they closed at 4:00 p.m. An appointment was made for 11:15 a.m. Monday. Mrs. Morris proceeded to the Pasco County Medical Society office on Route 54 with her husband. Upon arrival she was told the county medical society had not participated in the health fair and it was a private clinic that had participated. Mrs. Morris then drove to Bedi Medical Complex on the same road as the Pasco County Medical Society office. Upon arrival she told her husband to stay in the car. She went inside and asked if John Morris had an appointment for 11:15. When told yes, Mrs. Morris demanded all medical records they had on her husband to take to his regular doctor. After a short consultation she was given Exhibit 7. When told that the EKG was irregular, Mrs. Morris was quite concerned. When told that the full EKG could wait until a later time, Mrs. Morris, who was well aware of the necessity of prompt medical attention when a heart starts acting up, was upset. When she learned the appointment had been made with a private clinic, she was resolute in her decision to take the records to the doctor who was familiar with John Morris' medical history and condition. Allen R. Smith, M.D., completed his residency in internal medicine and became board certified in 1978. He started treating John Morris as a patient in October, 1981. When Mrs. Morris brought her husband to Smith's office, after the strip EKG had been taken at the mall, on his next scheduled visit, September 12, 1982, she requested an EKG be taken and gave Dr. Smith the strip EKG she had obtained from Respondent's clinic. All strips taken by Respondent or his associates and presented at this hearing were of poor quality due to wandering base lines with artifacts all through the strips. Artifacts are interferences from the electrical circuit into which the EKG machine is plugged and anything else not related to the heart that causes the needle to move. Although Respondent and Dr. Costarella both testified that certain information other than heart rhythm can be obtained from a single lead (strip) EKG, all of the other medical witnesses concurred that the only reliable evidence obtainable from a strip EKG is heart rhythm. The normal EKG contains 12 leads which measure electrical activity at various parts of the heart so a picture of the entire heart is generated; while a rhythm strip shows activity at only one point on the heart. With respect to the rhythm strip taken on Morris, all witnesses who examined the EKG found it to be of poor quality. Even Dr. Costarella, who worked at the clinic with Respondent and initially read the strip and marked it slightly abnormal, testified the strip was closer to being one that should be repeated than to abnormal. Dr. Smith categorized this strip as "It simply isn't readable. It's a bad rhythm strip. It's just uninterpretable." (TR p.155) Helvi Grinko went to Respondent's open house in March, 1982, with her husband and was given a free strip EKG (Exhibit 4). Dr. Bedi placed the lead on Mrs. Grinko's chest and operated the machine. Upon completion of the strip he told Mrs. Grinko she had a short life expectancy. Grinko testified that Respondent taped the lead to her chest with a piece of adhesive tape. Respondent contends he placed the lead under Grinko's breast and had to lift up the breast to properly secure the lead. It is not credible that Mrs. Grinko would fail to remember such a procedure. This patient is very much overweight but has never experienced any heart problems. At the open house she had been shown around the medical center and given a brochure on Respondent's diet program. She also talked to Respondent's father, who was presented as living proof of the success of Respondent's dietary program, which he calls the Polarization Diet. Mrs. Grinko testified that she was so stunned when told she was going to die that she does not remember much that occurred subsequent thereto. Respondent denied telling Mrs. Grinko she was going to die. After Mrs. Grinko left Respondent's clinic, she was called twice by someone identifying herself as calling from Bedi's clinic and asking her to come so Bedi could help her. When Mrs. Grinko went North on vacation in May, she visited her former family doctor who did an EKG but prescribed no medication or any other treatment for her. Dr. Sandra Mann examined Helvi Grinko when the latter moved to the area in 1981 and wanted to establish a family doctor. Dr. Mann is an internist. The EKG taken on Mrs. Grinko in April, 1981, indicated diffuse STD changes, there were no direct cardiac symptoms but her history of hypertension and overweight indicated further studies were needed to rule out heart problems. These other studies did not reveal any heart problems. Because of the wandering base line on Exhibit 4, the strip EKG taken on Grinko at Respondent's clinic cannot establish any irregularity in Grinko's heart. Randall H. Sells, M.D., is board certified in family practice and Helvi Grinko has been a patient of his since January, 1983. When he first examined her and took a cardiogram, it was perfectly normal. This patient has high blood pressure, is overweight, and has arthritic problems. His examination, Exhibit 4 and Exhibit 30, the one lead rhythm strip taken by Respondent on Grinko, reveals no irregular beats and, in his opinion, no diagnosis of serious heart problems can be made from this strip. This conclusion is concurred in by Dr. Neufeld (Exhibit 20 p. 16) who found this strip EKG to be of technically poor quality and showing no abnormality of heart. On the other hand, Respondent found the poor T-waves and obesity of patient indicated she may be hypothyroid. He showed her some literature used in conjunction with his Polarization Diet program which indicated people should stop killing themselves with what they eat. Dr. Costarella read Exhibits 4 and 30 as very bad because of the absence of T-waves which indicate the heart does not rest between beats. He acknowledged on cross- examination that a poor connection of the single lead could cause loss of T- waves, and the strip EKG could not support a conclusion that the patient had a serious heart condition. Salvatore Guerrera is 61 years old and has had poor circulation for sometime before he retired and came to Florida in 1980. He attended the health fair in July, 1982, conducted by Respondent and had an EKG strip taken. A short time later Guerrera was called by Respondent's clinic regarding the EKG and was told the EKG showed abnormalities. Mrs. Guerrera made an appointment for him to go to the clinic. While there with Mrs. Guerrera he was shown the strip EKG by Respondent and told something was wrong with his heart. When Mrs. Guerrera asked how could he tell from such a small strip, Respondent took a full 12-lead EKG and again pronounced Guerrera's heart was not beating right and tried to interest the Guerreras in his Polarization Diet program. Mrs. Guerrera suffers from agoraphobia and she testified by deposition (Exhibit 12). Respondent pointed out how much she needed her husband to take her places she could not go alone and that she should take care of him because he was the only husband she had. Guerrera did not enroll in Respondent's nutrition program but went to see his regular doctor, Allen Smith, for a checkup. Dr. Smith had first seen Guerrera October 10, 1980, when he came as a new patient. Dr. Smith saw Guerrera in his office on September 3, 1982. Guerrera's medical records (Exhibit 8) show he told Dr. Smith that he had been told by Respondent that he had an abnormal EKG and would die if he did not get nutritional prescriptions. The EKG taken by Smith showed no abnormality. When Guerrera returned four days later complaining of chest pressure, Dr. Smith suspected a hiatal hernia and subsequent tests so found. No diagnostic irregularities in Guerrera's EKG had been found by Smith and no cardiac symptoms are indicated. Guerrera has a slow heart rate (sinus bradycardia) but from the EKG Smith could not conclude Guerrera has a heart problem. Dr. Smith then obtained Guerrera's medical records from Respondent (Exhibit 9). The EKG in these records showed sinus bradycardia, some coarse artifact irregularity of the base line, but no other abnormal conditions. With no specific complaint of discomfort from the patient which would require further investigation, the EKG and patient history will not support a diagnosis of heart disease. Phyllis Hagedorn is a 62-year-old retired school teacher who attended the health fair in July, 1982, with her husband and participated in the free EKG strip. Mrs. Hagedorn is overweight and has a tendency towards high blood pressure. For this she took a drug called Apresazide. A few weeks after the health fair Mrs. Hagedorn received a telephone call suggesting she come to Respondent's clinic for a free complete EKG. About one week later she received a second call advising that the EKG taken at the health fair showed a slight irregularity and she should come in for a full EKG. She made an appointment for early September, 1982, at which time she went to the clinic where a full EKG was taken. She was then invited into a classroom area where Respondent discussed problems he observed on the EKG and to hear about a program on nutrition. Respondent marked with a pen on Hagedorn's EGK showing problem areas and advised Mrs. Hagadorn that she had a 70 percent blockage but his nutritional and exercise program could correct her condition. The price of $160 was quoted for four sessions at weekly intervals where she would be shown how to prepare tasty meals without the harmful fats, oils, salts, etc. If her husband also attended the price for him would be less than $160. Mrs. Hagedorn then went to her family doctor, Randall B. Sells, who is board certified in family practice. Dr. Sells, at patient's request, took a 12- lead EKG and no evidence of heart disease was found. When Dr. Sells examined the strip EKG and the full EKG taken by Respondent, he found both of them inadequate for diagnostic purposes. The strip was inadequate for the same reasons given with respect to the other strip EKG's. The full EKG had a wandering base line which makes it almost impossible to tell about the elevation or depression of the ST segments (TR p.54) . From a purely technical standpoint this EKG was inadequate to diagnose heart irregularities or abnormalities of the patient. No ischemic changes are observable in the EKG and, absent physical complaints from the patient, no blockage of the blood vessels can be predicted, let alone a specific percentage. Mrs. Hagedorn was subsequently subjected to a stress test but the test was stopped before any results could be reached because of difficulty in walking on the treadmill. Dr. Neufeld reviewed Respondent's records of Mrs. Hagedorn and found the strip EKG to be poor with a wandering base line but showed normal rhythm. The full EKG taken also had a wandering base line and Neufeld could find thereon no evidence of heart disease. Neither of these EKG's were technically capable of being used to make a definitive diagnosis regarding heart disease of Phyllis Hagedorn. Accordingly, no diagnosis of vessel blockage of 50 to 70 percent could be made from those EKG's. Ellen Buonocore and Robert Neville attended the health fair in July, 1982, and participated in the free EKG strips. About a month later Ms. Buonocore received a call advising her that there was an irregularity in the EKG and she should come in for a full EKG. She was also told there was an irregularity in Neville's EKG and he, too, should come in. She made an appointment for both of them. After a full EKG was taken Respondent, with EKG in hand, pointed out to Buonocore various irregularities and suggested she have a full physical examination. Neville suggested they go to their regular doctor. Respondent offered them a full physical exam for $70 each. Since that was less than they expected to pay their regular doctor, they accepted. Neville went for his physical exam the day before Buonocore and came back with her for a stress test. Respondent had told Neville that he was receiving an inadequate supply of blood to his brain and recommended the stress test to determine the extent of blockage. Buonocore was also told she had an inadequate flow of blood to the brain and she wanted all the tests Neville had been given. No extra charge for the stress test was quoted to Buonocore but the evidence is in dispute whether or not Neville was told there was an extra charge for this. Both commenced the stress test but Buonocore did not complete the test because the room was not air conditioned and it got too hot. When both complained of the bills exceeding the $70 quoted, the amount Neville had paid over $70 was refunded and Buonocore was charged only $70. Buonocore testified that during her eye examination Respondent called the nurse over to show what Buonocore understood to be a cataract in her eye. She also testified that he conducted the examination with a pen light. Respondent testified he used an ophthalmoscope, called the nurse over to show her an arcus senilis which some people thought was a cataract. Nothing was said to Buonocore regarding her having a cataract and no such indication was entered in the physical exam; accordingly, Respondent's version of the cataract incident is found to be correct. The EKG's taken by Respondent and subsequent EKG's taken by others reveal that Buonocore has earlier had a mild infarction of which she was unaware at the time it occurred and there has been no significant change since that time; and that Neville has a right bundle branch block which causes deep Q-waves in one lead which are not present in others, and therefore that Q-wave cannot be interpreted as lack of blood supply or evidence of ischemia. This diagnosis was concurred in by Dr. Neufeld, who opined that a diagnosis of heart disease could not be made from the EKG 's and physical examination taken by Respondent on Buonocore and Neville. Mary Mundy, a 57-year-old housewife, had been a patient of Respondent for treatment of back injury suffered in an automobile accident in 1980. On September 21, 1982, Mrs. Mundy went to her gynecologist, Dr. Madani, for a checkup and annual Pap smear. The Pap smear indicated the presence of squamous cell carcinoma. After discussing the problem with Mundy and her husband, Dr. Madani, on October 12, 1982, performed a fractional D and C and a cervical cone biopsy to check the tissue at the cervix. The tissue sample went to the lab and came back positive for cancer. Dr. Madani told Mrs. Mundy and her husband that she should have a hysterectomy to cure the cancer. She agreed and her operation was scheduled for about one month after the cone biopsy. Mrs. Mundy then called Respondent for an appointment to get a second Pap smear. When she arrived at his office and they were in consultation, she asked for a second Pap smear. Instead of examining her or performing the Pap test, Respondent talked to her about some of the programs he was running at the clinic and indicated to Mrs. Mundy that if she went on his diet and exercise programs she might not have to undergo the hysterectomy. He also discussed chelation therapy and Mrs. Mundy saw several people walking around the clinic carrying IV bottles taking chelation therapy. Although denied by Respondent, Mrs. Mundy was also told by Respondent that if it was his own mother he would not recommend a hysterectomy. Regardless of the words used, Respondent conveyed to Mrs. Mundy the concept that her cancer could be treated and cured by diet, exercise, chelation therapy, and/or laetrile. Respondent does not use laetrile in his practice and has never used laetrile so his purpose in mentioning that drug is not clear. After leaving Respondent's clinic, Mrs. Mundy realized that she had no choice but to have the hysterectomy and went to the hospital the next week as scheduled. Ernest Wiard is 69 years old and retired in 1970. In 1978 he had a blood clot and cardiac failure and has taken Coumadin since that time. When he moved to Florida in 1978, he was taking Aldomet, Apresoline, Lasix, Zyloprim, Colchicine, Digoxin, and Coumadin for his heart condition, gout, blood pressure, blood thinner, and excess fluids. He introduced himself at Bedi's clinic and was checked by Respondent's physician's assistant and got his prescriptions for these medications. Wiard first saw Bedi in October, 1980, for his three-month checkup. At that time he did not need any prescription refills. On January 15, 1981, Wiard went to the pharmacy to get his prescription for Coumadin refilled. The pharmacist noted the prescription was over a year old, could not be refilled, and that Wiard needed a new prescription. He told Wiard he would call Bedi's clinic and that Wiard could return later in the day for his medication. Later that afternoon Wiard returned to the pharmacy and was told the clinic had never called back. Wiard had been told by his previous doctor that he would always have to take Coumadin so he then went to the clinic and saw Respondent. Respondent took out Wiard's chart and told him that he wanted Wiard to come in the following day for a physical examination and that he wanted to put Wiard on his Polarization Diet and get him off of medication. Wiard told Respondent that he had been told he would be on Coumadin the rest of his life but no new prescription was forthcoming. The following day Wiard reported to the clinic and spent all day undergoing his physical examination and the following day, January 17, 1981, after signing a release, he was given a stress test. During the examination Wiard requested the prescription for Coumadin. Respondent had Wiard bring his wife in so he could talk to both of them about the Polarization Diet. While preparing Wiard for this diet, Respondent told him to stop all medication but Digoxin. Respondent explained to Wiard how Respondent's father had been on numerous drugs as a result of heart problems and how he had been able to stop taking medication, start feeling good again, and enjoying good health since he went on the Polarization Diet and the exercise program. On January 20, 1981, when Wiard went to Respondent for his three-month checkup his legs were beginning to cramp and hurt him. He told Respondent his legs were beginning to stiffen and burn and asked to be put back on his medication. Respondent diagnosed this problem as lack of potassium and drug withdrawal without examining Wiard's legs. Respondent gave Wiard a prescription for Slow K to increase his potassium level and Tranxene for nerves. Wiard took those drugs as prescribed until he entered the hospital. When Wiard went to Respondent on January 16, 1981, to get his prescriptions renewed, he had three Coumadin left. These ran out January 18,1981. After the January 20 visit Wiard's legs continued to hurt and cramp. On Friday evening, February 2, 1981 Wiard's legs were hurting badly and Mrs. Wiard called Respondent's home. Respondent was going to his office to tend to another patient and told Mrs. Wiard to bring her husband down. That night around 9:00 p.m. Mrs. Wiard, with the help of a neighbor, got Mr. Wiard in the car and into Respondent's office. Wiard told Respondent that his legs were burning and cramping and Respondent told him to do an exercise demonstrated by Respondent, go home, and take two aspirin. Wiard again asked Respondent to put him back on his old medication. Respondent asked Wiard to continue on his diet and exercise program for another week to give it a chance to work. Wiard testified that Respondent did not examine his legs. Respondent testified that he did examine Wiard's legs and found nothing wrong. No notes were made in Wiard's chart reporting the actions taken by Respondent on that evening. The following Monday afternoon around 3:00 p.m., on February 5, 1981, Mrs. Wiard got her husband in the car and drove him to Respondent's office. Upon arrival she went in to get a wheelchair because Wiard's legs were so bad he could not walk. Respondent saw her and went out to the car with her to see Wiard. When he saw Wiard, Bedi apparently realized he had a sick man on his hands and asked Wiard if he wanted to go to the hospital. Wiard was sitting in the front seat on the passenger's side of the car. Respondent testified he opened the car door and examined Wiard's legs and saw no mottling or discoloration and felt a good pulse. Wiard and Mrs. Wiard testified Respondent did not examine Wiard's legs. Respondent told Wiard to go home and take two Coumadin, to which Wiard replied that he had no Coumadin. The physical configuration of the front seat of a car with a door obviously hinged to the front is such that an examination of the legs of the passenger whose feet were on the floor of the car would be awkward, if not difficult. At this time Respondent contends he first became aware that Wiard was no longer taking Coumadin after he asked Mrs. Wiard what drugs her husband was taking and Coumadin was not included in her reply. He felt two might be needed to thin the blood that had received no Coumadin for some two weeks. No explanation was provided why more specific action was not taken by Respondent when Mrs. Wiard told him he had no Coumadin to take. Respondent's testimony that Wiard's legs appeared normal to sight and touch does not square with a report of the emergency room at Dade City Community Hospital where Wiard was taken around 9:00 p.m. on February 5, 1981. Upon his arrival there Wiard was examined and found to have arterial occlusion of both lower extremities, the legs were mottled and discolored with evidence of very poor circulation. Treatment was beyond the capabilities of Dade City Community Hospital and Wiard was transferred to Tampa General Hospital by ambulance that night. He arrived at Tampa General early on the morning of February 6, 1981. His examination there revealed a major decrease in the blood supply to Wiard's legs (Exhibit 15 p. 7) and an irregular heartbeat. Arteriograms were taken which suggested a embolic occlusion. Further procedures were carried out. Heparin was administered for anticoagulation. Clots were removed from both legs and Wiard was carefully monitored for circulation in the legs. Ultimately on February 10, 1981, Wiard's right leg was amputated three inches above the knee. Respondent's Director of Public Relations, Linda Sharp, started working for Respondent the Monday following the health fair conducted mid-July, 1980. She is the one who made the telephone calls to those who had strip EKG's taken. She has been trained by Respondent to conduct seminars for senior citizens to explain heart disease and how diet relates to the circulatory system. She has had no medical training other than that provided by Respondent. Dr. Costerella had reviewed more than half of the strip EKG's taken and of those he reviewed only 10 to 15 percent were readable. On those that were too bad to read he put "irregular," "slightly abnormal," or "repeat." All of those strip EKG's with irregular or abnormal on them resulted in a phone call from Ms. Sharp telling the patients that they had an irregular or abnormal EKG and they should come in for a free full EKG. Once the patients came to the office they were given the free EKG and then given some explanation of the EKG and a sales pitch on the diet and exercise program. Respondent has embarked on a program he refers to as preventive medicine. He was led to this program a few years ago in trying to take care of his father who suffered from cardiovascular problems. During this time Respondent became a disciple of Dr. Sodi Pollaris, who is described by Respondent as being one of the foremost cardiologists in the world and who practices in Mexico, and who treats cardiac patients by dietary means. This diet focuses on fruit and vegetables, no red meat, reduction in salt, no canned vegetables, etc. Respondent talked to Dr. Sodi's patients in Mexico and tried the diet and exercise program on his father. When his father got better after going on the program and giving up his medications, Respondent further developed the program and solicited patients to come in to learn about the Polarization Diet. In setting up the strip EKG's at the open house and health fair at the mall, Respondent used those EKG's to get new patients into his office. Although Respondent contends he is trying to help those cardiac patients to a better life, and, in fact, made no money whatsoever on several of the witnesses who testified in these proceedings, nevertheless he brought these people into his office by giving them inaccurate medical information and thereafter attempted to sell them on his program. Respondent's testimony that he can read changes in the electrocardiogram when the patient goes on the diet and can detect patients' cheating on the diet by use of an electrocardiogram differs from the testimony given by all other witnesses regarding the information obtainable from an electrocardiogram. Furthermore, his testimony that such information can be obtained from a strip EKG also conflicts with all other medical testimony presented. This misplaced confidence also appears in the use of stress tests by Respondent. All other medical witnesses who testified on the subject of stress tests did not deem it prudent for anyone other than a cardiologist to give a patient a stress test; and then, only if appropriate equipment was readily available with the necessary expertise of the physician to take care of the cardiac accident which can readily occur during a stress test. These witnesses included family practitioners, such as Respondent, and internists. The latter are generally better qualified to treat heart patients than are family practitioners, although the latter are qualified to treat routine heart conditions.
