Findings Of Fact The Respondent, Stephen L. Watson, M.D., has been practicing medicine in Lakeland, Florida, since 1945. Since 1950, he has been board-certified in obstetrics and gynecology. Until this case, he has not been the subject of any Board of Medicine disciplinary proceeding. He recently closed his practice of medicine due to his own poor health. The Respondent saw B. D., as a gynecology patient, for the first time in December, 1983. She was 33 years old at the time and was obese, weighing 184 pounds and standing only approximately five feet, four inches. She also had borderline high blood pressure, at 140/90. On the patient's second visit in July, 1984, the Respondent discussed her weight and gave her a book on diet and weight loss entitled, "The Lighter Side of Life, the Doctor's Program that Really Works." He discussed the contents of the book with her, emphasizing certain parts of it. He also prescribed a month's supply of an appetite suppressant called Fastin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next visit was a weight conference on January 2, 1987. On this visit the patient weighed 212; her blood pressure was 140/90. The Respondent again discussed weight and diet with the patient and prescribed a month's supply of another appetite suppressant called Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Didrex contains the anorectic agent benzphetamine hydrochloride. It is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Didrex is contraindicated in patients with moderate to severe hypertension, and caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. At the visit on January 2, 1987, it also was arranged that the Respondent would have blood work done on January 6, a pelvic examination on January 7, and another weight conference on January 29, 1987. As often would happen during the long doctor-patient relationship, the patient missed all three appointments and did not request a refill of her medications. The patient's next visit was for another weight conference on February 10, 1987. She had lost 12 pounds (down to 200), and her blood pressure reading was down to 130/88. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Ten days later, the patient came in complaining of "nerves" after taking her medications. The Respondent discontinued the Didrex and the diuretic and scheduled the patient for another weight conference for March 10, 1987. The patient missed the March 10, 1987, appointment as well as the next two rescheduled appointments, and she did not request a refill of her medications. Finally, the patient kept the third rescheduled appointment for a weight conference, for May 6, 1987. By this time, the patient's weight was back up to 208. Her blood pressure reading was 120/80. The Respondent prescribed a month's supply of another appetite suppressant called Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her weight conference scheduled for June 3, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for June 11, 1987. This time, her weight was back down, to 197, and her blood pressure reading was 120/80. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient again missed her next scheduled weight conference, for July 9, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for July 13, 1987. This time, her weight was down further, to 187, and her blood pressure reading again was 120/80. The Respondent's course of treatment continued to seem to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next weight conference was on August 17, 1987. Her weight was down a little more, to 183.5, and her blood pressure reading remained at 120/80. The Respondent's course of treatment continued to seem to be effective, although the patient's rate of weight loss was decreasing. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic apparently due to a bladder problem. The patient missed her next scheduled weight conference, for September 15, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on October 9, 1987. Her weight was up a little, to 184.75. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for November 6, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on December 7, 1987. Her weight was down a little, to 183. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for January 5, 1988, and did not request a refill of her medications. The patient's next rescheduled weight conference was on February 18, 1988. Her weight was up a little, to 187.5. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of another appetite suppressant called Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. Tenuate Dospan contains the anorectic agent diethylpropion hydrochloride. Like Didrex, it is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. It is contraindicated in patients with severe hypertension, and caution is to be exercised in prescribing it for any patient with hypertension. The Respondent did not see the patient again for weight control, or prescribe any more medication, until May 3, 1988, when the patient was seen for bladder problems. Her weight was down a little, to 181.5, and her blood pressure reading was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic again apparently due to a bladder problem. The patient preferred Tenuate Dospan, and the Respondent changed the prescription to another month's supply of Tenuate Dospan. The patient missed the next two conferences, scheduled for August 8 and rescheduled for August 9, 1988, and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a weight conference on December 2, 1988. Her weight was up a little, to 185. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next four scheduled appointments and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a blood pressure conference on June 28, 1989. Her weight was up significantly, to 200, and her blood pressure reading was up significantly, to 140/100. Although the patient still was relatively young (approximatly 39), and the Respondent believed there was a causal connection between the patient's weight and blood pressure, the Respondent prescribed only a month's supply of Enduron, a medication for hypertension. The patient missed her next two scheduled blood pressure conferences and did not request a refill of her blood pressure medications, or request any other medications. She did not see the Respondent or get any more medications from him until she saw him for blood in the urine on October 3, 1989, and had a urinalysis and conference. At the time, her weight was up a little more, to 203, and her blood pressure reading was 140/90. The Respondent prescribed an antibiotic and, for reasons not apparent from the evidence, a month's supply of a mild antidepressant, called Elavil. On or about October 23, 1989, the patient telephoned for a refill of her Enduron prescription, which was about to run out, and the Respondent prescribed another month's supply. The patient again missed her next weight conference scheduled for October 30, 1989, and did not request any other medications. She did not see the Respondent or get any more medications from him until a rescheduled weight conference on December 11, 1989. By this time her weight was up to 217, and her blood pressure reading was 140/98. The Respondent was aware that amphetamine-like appetite suppressants should be used with caution with patients having moderately high blood pressure, as the patient had by December 11, 1989. But he also continued to believe that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. He prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (Tenuate is essentially the same drug as Tenuate Dospan but is shorter lasting.) On January 5, 1990, the patient telephoned the Respondent with a complaint of "nerves." The Respondent prescribed another month's supply of Elavil, with authority for two refills. The patient's next weight conference was on January 24, 1990. Her weight was up a little more, to 220, and her blood pressure reading was 160/98. At that point, it seemed that perhaps the Tenuate Dospan was not effective. Although there could be other explanations why the patient was not losing weight, and it was possible that all appetite suppressants had become ineffective, the Respondent decided to switch the patient to Didrex, which seemed to have been effective in the past, and prescribed a month's supply, to be taken in conjunction with the diet recommendations, along with a diuretic. He also changed her blood pressure medication to Wytensin. The patient missed her next weight conference, scheduled for January 31, 1990, and did not request any additional medications. The patient did not see the Respondent again, or get any additional medications from him, until March 21, 1990, when she saw him to get a letter for employment purposes certifying that she was disease-free. Her weight was up to 226, and her blood pressure was 164/96. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic and another month's supply of Wytensin. The patient did not see the Respondent again, or get any additional medications from him until August 28, 1991, when she saw him to complain of blood in the urine. At this time, her weight was 234, and her blood pressure reading was 140/90. In addition to treating the urine problem, the Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic and a month's supply of Wytensin. The patient missed her appointment for a pelvic examination on September 5, 1991, and did not see the Respondent, or get any additional medications from him until she went to a weight conference on December 11, 1989. Her weight was 234.5, and her blood pressure reading was 140/94. The Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (It is not clear from the evidence why no blood pressure medication was prescribed.) The patient missed her appointment for a pelvic exam on December 17, 1991, and missed scheduled weight conferences for February 10, 11, and 19, 1992. She did not request any additional medications during this time. The patient made her next scheduled appointment on March 16, 1992, when the Respondent discussed her weight, blood pressure and complaint of headaches. Both her weight and her blood pressure were at their highest: weight, 237; blood pressure reading, 150/110. At this point, there was a real question whether the appetite suppressants still were effective in controlling the patient's weight and thereby helping reduce the patient's blood pressure. On the other hand, the patient continued to miss weight conferences and not follow through on the Respondent's instructions, and it was not clear whether the patient ever had followed the Respondent's weight control treatment long enough to give it a fair chance to work. The patient's blood pressure now was moderately to severely high; on the other hand, she still was only about 42 years of age, and her weight still could have been contributing to her high blood pressure. Nonetheless, the Respondent decided to prescribe only Wytensin on March 16; he also scheduled a complete physical for March 20, 1992. On March 20, 1992, the Respondent had the patient undergo a complete physical. Her weight still was 237, and her blood pressure reading was 160/120. He switched her blood pressure medication to Accupril and decided not to prescribe any appetite suppressants at that time. He scheduled the patient for a weight conference on April 3, 1992. On April 3, 1992, the patient's weight still was 237, but her blood pressure reading was 150/110. Although the patient's blood pressure still was moderately to severely high, the Respondent decided to try an appetite suppressant to reduce her weight in the hopes of, together with the blood pressure medication, effecting a lasting reduction in her blood pressure. He prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. On April 14, 1992, the patient telephoned the Respondent to report that her blood pressure still was up and that she continued to suffer from headaches. The Respondent decided that it was time to refer the patient to a specialist in internal medicine and made an appointment for her. The patient missed her next scheduled weight conference on April 16, 1992, and missed the appointment with the internist which the Respondent had scheduled for her. She never saw the internist. The patient's next appointment was on May 6, 1992. The Respondent discussed the patient's weight and her hypertension. Her weight was 236, and her blood pressure reading was down to 144/100. The Respondent decided to prescribe a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient overdosed on a pain medication (not the appetite suppressant) and was hospitalized on June 4, 1992. She missed the next scheduled weight conference on June 15, 1992. She did not request any additional medications. The patient's next appointment with the Respondent was on June 18, 1992. She weighed 230, and her blood pressure reading was 140/110. The Respondent prescribed only Accupril and an iron supplement. The Respondent only saw the patient once more, on July 17, 1992, for gynecological problems, and referred the patient to a specialist. He did not prescribe any medications. The patient's blood pressure was 130/100. Her weight was not recorded. The evidence does not reflect that the patient, B. D., grew progressively dependent on the appetite suppressants the Respondent prescribed for her. There was no evidence that the patient ever asked for a refill or new prescription early. She often missed scheduled appointments, resulting in gaps of time between prescriptions when the patient presumably had no appetite suppressants available to her. There also were extended periods of time between visits during which time the patient presumably had no appetite suppressants available to her. Some reputable physicians now seriously question the use of appetite suppressants. There is some evidence that patients lose as much weight and maintain as much weight loss without them as with them. The trend in the late 1980s and early 1990s has been to treat patients for obesity with behavior modification (essentially, diet and exercise) only. But there is no evidence that it is below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances to treat patients for obesity by prescribing appetite suppressants in conjunction with diet recommendations. It is true that the Respondent prescribed appetite suppressants for longer periods of time than recommended in the medical and pharmaceutical literature. The literature recommends using appetite suppressants only during the early weeks of a weight reduction program. The reasons are twofold and related: first, the patient generally builds a tolerance to the appetite suppressant, making them less effective; second, the patient can become dependent on them. The goal is to use appetite suppressants to begin reducing caloric intake for initial weight loss, while changing eating habits for long term reduction in caloric intake and weight. The problem confronting the Respondent in this case lay in the nature of the patient's noncompliance. She would begin the program but not follow it or continue with it for long. When she returned to the Respondent after a long hiatus, it was like starting the program over again. The evidence did not prove that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to repeatedly restart his treatment for obesity, namely by prescribing appetite suppressants in conjunction with diet recommendations. There were occasions when the Respondent prescribed an appetite suppressant when the patient's blood pressure reading was high. According to the medical and pharmaceutical literature and the expert medical testimony, caution should be exercised in prescribing these medications for patients with high blood pressure. But the exercise of that caution is a matter of medical judgment, based on an overall knowledge and understanding of the patient and circumstances involved. Only once, on April 3, 1992, did the Respondent prescribe an appetite suppressant (Tenuate Dospan) when the patient's blood pressure reading was so high (150/110) as to clearly contraindicate the use of the appetite suppressant. On all other occasions, the patient's blood pressure would be considered mildly or moderately high, requiring the Respondent to exercise caution, which he did. In all cases, the Respondent believed that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. Although some physicians would disagree with the Respondent's medical judgments, except for April 3, 1992, it was not proven that the Respondent's medical judgment in this case fell below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. However, it is found that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to prescribe Tenuate Dospan on April 3, 1992. It was not proven that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent not to refer the patient to a specialist for hypertension before April 14, 1992. The first evidence of severe hypertension appeared on her visit on March 16, 1992. But the Respondent had not seen the patient since December, 1991, due to missed appointments, and it was reasonable at that point for the Respondent not to refer immediately. It could be argued that he should have referred the patient after one of the next two visits, but the delay until April 14, 1992, was fairly short. It was not the Respondent's fault that the patient did not keep the appointment with the specialist which he made for her. It should be noted that the patient does not complain about the level of care and treatment given by the Respondent. Nor is there any evidence that the Respondent's care and treatment harmed the patient. Apparently, while the patient was hospitalized for overdosing on pain medication unrelated to the Respondent's care and treatment, the patient's medical records were brought to the attention of the predecessor of the AHCA, and it appeared to that agency (and to the AHCA) that the Respondent was guilty of worse practice of medicine than ultimately was proven in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent guilty of a single violation, on April 3, 1992, of Section 458.331(1)(t), which also resulted in a technical violation of Section 458.331(1)(q), Fla. Stat. (1993); (2) requiring the Respondent to notify the Board or the AHCA if he reopens his practice of medicine; (3) placing the Respondent on probation on appropriate terms in the event the Respondent reopens his practice; and (4) fining the Respondent $500. RECOMMENDED this 15th day of November, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON 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 15th day of November, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-2375 To comply with the requirements of Section 120.59(2), Fla. Stat. (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-8. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Rejected as not proven. (The Respondent testified.) Accepted but subordinate and unnecessary. Accepted. First sentence, subordinate to facts contrary to those found; second sentence, subordinate to facts found. Rejected as not proven that the patient's hypertension was severe. Otherwise, accepted but subordinate to facts contrary to those found. 14.-19. Accepted and incorporated. Rejected as not proven, except for patients with severe hypertension. First sentence, rejected as not proven. (He believed it permissible because the patient's blood pressure was not stable.) Second sentence, accepted but subordinate to facts contrary to those found. Third sentence, accepted but subordinate to facts contrary to those found, and unnecessary. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven. Accepted. Subordinate to facts found. Accepted but subordinate to facts contrary to those found. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven as to Didrex after 1990; otherwise, accepted and incorporated. First sentence, accepted and incorporated. Second sentence, accepted but subordinate to facts contrary to those found, and unnecessary. (The AHCA did not charge inadequate records.) 27.-29. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Accepted but subordinate to facts contrary to those found. Accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted and incorporated. Rejected as not proven that referral was required in 1984 or that the patient's weight and blood pressure did not respond to treatment before 1988. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted but subordinate and unnecessary. Rejected. They knew it to the extent that it is the same as for an internist. 37.-38. Accepted but subordinate and unnecessary. 39. Rejected as not proven and as contrary to the facts found. Respondent's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5. Accepted but subordinate and unnecessary. 6.-20. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted but subordinate and unnecessary. 23.-28. Accepted and incorporated to the extent not subordinate or unnecessary. Other than evidence that she may have become nervous on occasion from the appetite suppressants, accepted and incorporated to the extent not subordinate or unnecessary. Accepted. The second occasion is irrelevant, having occurred after the events in issue in this case. The first is accepted and incorporated to the extent not subordinate or unnecessary. 31.-32. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted and incorporated. Accepted but subordinate and unnecessary. 36.-37. Accepted and incorporated. 38.-40. Accepted. Subordinate to facts found. First sentence, accepted and incorporated. Second sentence, accepted but subordinate and unnecessary. Accepted (that it is not necessarily inappropriate) and incorporated. Accepted. First two sentences, incorporated; second, subordinate to facts found. Accepted. Subordinate to facts found. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted but subordinate to facts found. 46.-47. Accepted and incorporated. 48. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted and incorporated. COPIES FURNISHED: Alex D. Barker, Esquire Elaine Lucas, Esquire Agency for Health Care Administration 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211-7466 John A. Naser, Esquire 1401 South Florida Avenue Suite 201 Lakeland, Florida 33802 Dr. Marm Harris Executive Director, Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue DOAH Case No. 02-0949: Whether Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 02-1299: Whether Respondent committed the violation alleged in the Administrative Complaint dated February 19, 2002, and, if so, the penalty that should be imposed.
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. Harbour Health operates a licensed nursing home at 23013 Westchester Boulevard, 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 October 22 through 25, 2001, AHCA conducted an annual licensure and certification survey of Harbour Health, 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 F325 (violation of 42 C.F.R. Section 483.25(i)(1), relating to maintenance of acceptable parameters of nutritional status). 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 F325, AHCA imposed a conditional license on Harbour Health, effective October 25, 2001. The license expiration date was August 31, 2002. The survey allegedly found a violation of 42 C.F.R. Section 483.25(i)(1), which states: Nutrition. Based on a resident's comprehensive assessment, the facility must ensure that a resident-- Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible. . . . This requirement is referenced on Form 2567 as "Tag F325." The survey found one instance in which Harbour Health allegedly failed to ensure that a resident maintained acceptable parameters of nutritional status. The surveyor's observation on Form 2567 concerned Resident 5, or "R-5": Based on observations, record review and staff interviews, the facility failed to maintain acceptable parameters of nutritional status and did not use all possible interventions, to prevent an unplanned, severe weight loss (7.8 percent in a two month period) for 1 (Resident 5) of 20 active sampled residents. The findings include: During her lunch on 10/22/01 at approximately 12:20 P.M., Resident 5 was observed clinching her teeth together making it difficult to get food into her mouth. Resident 5 was observed on 10/23/01 at 12:30 P.M., taking a limited amount of thickened liquids from her nosey cup, and clinching her teeth together making feeding her more difficult. Resident 5 was observed 5:25 P.M. until 5:55 P.M. on 10/23/01, taking small sips from the nosey cup and clinching her teeth together making it very difficult for the Certified Nursing Assistant (CNA) to feed her 25 percent of her meal. These observations were made in the assisted dining room on A-Wing. Record review of Resident 5's chart, documents 5/1/01 she weighed 127 pounds. On 7/2/01 and again on 7/16/01, her weight was documented 117 pounds. This is a severe weight loss of 7.8 percent in a two month period. Review of the resident's care plan dated 7/18/01, revealed the resident's nutrition problem was "Res. is on a puree diet with thickened liquids-- is continuing to lose weight-- is terminal-- weight is down 6 pounds for the month-- on weekly weight-- consumes 25-50 percent of her meals-- small portions at lunch-- super cereal on breakfast tray and Carnation Instant Breakfast on other trays. Resident can be combative during meals-- resists any attempt to assist her with eating-- is very difficult to feed." Approaches to address the problem included consult with Registered Dietician as needed and to monitor labs. Further review of the care plan included the problem: "Resident is on psychotropic meds for dementia with psychosis as evidenced by . . . increased agitation and resisting care." Review of the resident's physician orders reveal the resident began receiving Risperdal in July 2001 for the diagnosis of psychosis. The record also revealed that the resident was given a terminal status in January 2001. During an interview at 5:20 P.M. on 10/23/01, regarding Resident 5's evening meal being delivered after the other 3 residents at her table, the Certified Nursing Assistant stated, "She don't eat nothing anyway." Interview with CDM (Certified Dietary Manager) and Consulting Dietician on 10/23/01 at approximately 4:45 P.M., regarding resident's severe weight loss and limited nutritional intake, revealed that the Consulting Dietician stated she was unaware of this resident. The CDM stated the resident clinches her teeth, refuses food, and they have tried everything else. She stated that the resident was terminal and that the family did not want a tube feeding placed. The resident was put on thickened liquids by a speech therapist in 1998 for dysphagia, but there had been no speech therapy follow-up. They confirmed that no psychiatric consult was ordered since the care plan was developed, despite continued behaviors during feeding. An interview was conducted with the CDM joined by the DON regarding Resident 5's weight loss and possible interventions on 10/24/01 at 3:05 P.M. It was identified that no routine snacks were ordered, no psychiatric follow-up nor speech therapy follow-up, nor medication adjustments had been done during May 2001 through July 2001. The CDM stated that the facility only acknowledges a 5 percent weight loss at an interval of 1 month, and 10 percent at a 6 month interval as significant, but would not look at a 7.5 percent because it would not trigger on the Minimum Data Set. On 10/24/01 at 3:55 P.M., during an interview with the Unit Manager regarding Resident 5, she stated there was no psychiatric or mental health evaluation ordered, it was only on her care plan. Diane Ashworth was the survey team member who recorded the observation of R-5. Ms. Ashworth based her findings on her observations of R-5, a review of the resident's medical records, and interviews with Harbour Health staff. R-5 was a 92-year-old female who had resided at Harbour Health since 1998. She suffered from dementia with psychosis, in particular end-stage Alzheimer's disease. Her worsening condition caused her physician to request a neurological consultation in January 2001. The consulting neurologist diagnosed her condition as terminal. R-5 was severely impaired cognitively, and was completely dependent on Harbor Health staff for all of her care. R-5 was unable to feed herself. For over three years, Harbour Health has implemented a "restorative dining" program for residents with eating problems. In the restorative dining program, the resident is taken to a quiet area and given one-to-one attention by a CNA during meals. R-5 has been in the restorative dining program since its introduction. During her entire stay at Harbour Health, R-5 was very difficult to feed. She would clench her teeth, cover her mouth and push away. At times she would take the food into her mouth, then spit it back into the face of the caregiver. R-5's medical condition made it impossible to reason with her about the importance of maintaining nutrition. The CNA assigned to R-5 as her restorative aide would spend up to two hours feeding one meal to her. The CNA would attempt to feed R-5 until her agitation and resistance made it impossible. The CNA would refrigerate the food, then wait for R-5 to calm down. Then the CNA would reheat the food and begin the process again. Because of her Alzheimer's and her difficult behavior during meals, R-5 was identified as at risk for weight loss and dehydration. Harbour Health's care plan for R-5 identified several strategies for maximizing R-5's caloric intake, and called for consultation with the facility's registered dietician when needed. R-5 was on a no-sodium-added puree diet, taking thickened liquids in place of solid food. Because she tended to consume only 25 to 50 percent of the food offered at meals, the facility offered her 3,252 calories per day at meals, well in excess of the 1,677 to 1,960 calories required to maintain her usual body weight of 120 to 123 pounds. Staff noted that R-5 appeared overwhelmed by large portions of food and began offering her smaller amounts at one time. R-5 was offered fortified cereals and potatoes, and supplements such as Health Shake and Carnation Instant Breakfast. If R-5 showed signs of accepting certain foods, such as eggs, staff would order extra portions of those foods. Snacks were offered between meals, and R-5 was given vitamin C, zinc, and multivitamins with iron to supplement her nutrition. Staff employed items such as a "Nosey Cup," a cup designed to permit its being held near the resident's face without bumping the nose, to ease the feeding process. Harbour Health's standard practice was to weigh residents once per month. If the monthly weights indicated a problem, then Harbour Health would commence weighing the resident on a weekly basis until the problem was resolved. As noted by Ms. Ashworth, R-5 weighed 127 pounds at her monthly weighing on May 1, 2001. At her next monthly weighing on June 1, 2001, R-5 weighed 123 pounds. At the following monthly weighing on July 2, 2001, R-5 weighed 117 pounds. Ms. Ashworth calculated the weight loss from May 1 to July 2, 2001 as 7.8 percent of R-5's body weight. Noting the weight loss, Harbour Health placed R-5 on weekly weights in July 2001. On July 16, 2001, her weight remained at 117 pounds. On July 23, 2001, her weight had increased to 123 pounds. On August 1, 2001, R-5's weight was 125 pounds. Thus, by early August R-5 had regained nearly all of the weight she had lost between May and July 2001. On July 6, 2001, R-5's attending physician prescribed Risperdal, an antipsychotic medication, to calm her severe agitation and constant movement. Risperdal can act as an appetite stimulant. The administration of Risperdal to R-5 coincided with her weight gain in July 2001. When the facility became aware of R-5's weight loss in July 2001, staff began offering R-5 food more often, including more snacks between meals. The attending physician removed the sodium restriction from R-5's puree diet. Aside from those steps, Harbour Health maintained the same nutritional procedures for R-5. The agency alleged that Harbour Health was deficient in not involving the consulting dietician when it became aware of R-5's weight loss. The agency further alleged that Harbour Health should have ordered a psychiatric consultation and a speech therapy consultation. Regular snacks should have been ordered, and R-5's medications should have been adjusted. Harbour Health contended that it was already doing everything possible to ensure R-5's nutritional status. The only alternative to the puree diet would be tube feeding. R-5's son, who acted as her guardian, made it clear to the facility that he would not consent to tube feeding. In May 2001, R-5 suffered from an upper respiratory infection diagnosed as bronchitis by her attending physician. On May 14, 2001, the physician ordered the antibiotic Levaquin; nebulizer treatments with Albuterol and Atrovent, both bronchodilators; and oral administration of Robitussin. All of these medications were ordered and administered for a period of one week. Harbour Health contended that R-5's respiratory infection completely explained her weight loss. The evidence does not entirely support that contention. The medical records indicate that R-5's condition was largely resolved by the latter part of May 2001. R-5 lost four pounds during the month of May 2001. The majority of R-5's weight loss occurred during the month of June 2001, after her bronchitis was treated and apparently resolved. At most, R-5's weight loss was only partially explained by her upper respiratory infection. Dr. Michael Brinson, R-5's attending physician, testified that it is expected that an end-stage Alzheimer's patient will lose weight, because at some point the resident loses the will to live. In Dr. Brinson's opinion, R-5 had reached this point, which explained her refusal to eat. He was aware of R-5's weight loss. Given R-5's clinical condition, the weight loss did not concern Dr. Brinson, who deemed it irrelevant to her care and treatment. Even Ms. Ashworth, the agency RN who performed the survey observation of R-5, agreed that weight loss can be a symptom of end-stage Alzheimer's. R-5 had been provided with a speech consultation and speech therapy in 1998. She was discharged from speech therapy in March 1998 because it was determined that nothing more could be done for her. Dr. Brinson testified that a speech therapy consultation would have been useless in July 2001. Speech therapy is called for if the resident's refusal to eat is related to a swallowing problem. R-5 had no swallowing problem. Catherine Rolin, the restorative nurse who supervised R-5's feedings, confirmed that there were no indications R-5 had difficulty swallowing, or had choked or aspirated during the time she was losing weight. Dr. Brinson opined that R-5's terminal diagnosis with end-stage Alzheimer's disease made a psychiatric consultation of no value. R-5's cognitive impairment would have rendered her unable to participate in any psychiatric examination. Dr. Brinson came to the facility at least once a week. His Advanced Registered Nurse Practitioner ("ARNP"), Vickie Swank, came to the facility several times a week. Dr. Brinson would have had to order any psychiatric or speech therapy consultation, or any laboratory work. Dr. Brinson believed that none of these was appropriate for R-5. The interdisciplinary team overseeing R-5's care included the facility's certified dietary manager. The team was aware of R-5's weight loss as of July 2, 2001, and decided that R-5's status did not trigger a need to consult the registered dietician. Deborah Blackburn, a dietician and expert in nutrition, reviewed R-5's records and concluded that there was no need to consult a registered dietician. Ms. Blackburn opined that the facility was taking all reasonable steps to maintain R- 5's caloric intake and nutritional status. She could not think of a workable approach that Harbour Health had failed to employ. Aside from the weight loss itself, R-5 suffered no skin breakdown or other negative effects. Viewing the evidence in its entirety, it is found that AHCA failed to prove the elements of Tag F325 by a preponderance of the evidence. R-5 lost the weight then quickly gained most of it back with no dramatic changes in Harbour Health's approaches to her feeding and overall nutrition. This fact demonstrates that R-5's weight loss was caused not by Harbour Health's failure to provide adequate nutrition, but by a combination of R-5's terminal Alzheimer's disease and her upper respiratory infection. Once Harbour Health became aware of the weight loss, it reacted appropriately and successfully. The steps that the agency faulted Harbour Health for failing to take--psychiatric consultation, speech therapy consultation, dietician consultation, and medication adjustments--were demonstrated to be unnecessary in light of R-5's condition.
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 dismissing the Administrative Complaint in DOAH Case No. 02-1299, and rescinding the notice of intent to assign conditional licensure status to Harbour Health Center in DOAH Case No. 02-0949 and reinstating the facility's standard licensure status. DONE AND ENTERED this 23rd day of September, 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 23rd day of September, 2002. COPIES FURNISHED: Ursula Eikman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dennis L. Godfrey, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310L St. Petersburg, Florida 33701 Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valinda Clark Christian, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue The issue is whether a penalty should be imposed on Pettegrove Equipment for driving a truck over a bridge when the truck weighed more than the posted bridge weight limit.
Findings Of Fact Raymond S. Cran drove a loaded dump truck owned by Pettegrove Equipment over a bridge on State Road 850 which crosses over Florida's Turnpike on September 26, 1990. The truck weighed 69,100 pounds. The truck was a straight truck, not a tractor trailer combination. The bridge which Mr. Cran drove across is a low limit bridge. Signs were posted in five places on the approaches to the bridge of the 26 ton limit for straight trucks. The first is at the intersection of State Road 850 and East Highland Pines Drive, which states "Weight Limit Restriction Ahead." One mile from the bridge at the intersection of Green Meadows Road is a second sign which states "Weight Limit" and has silhouettes of a straight truck and of a tractor trailer combination, showing a 26 ton limit for the straight truck and a 38 ton limit for the tractor trailer combination (tractor trailers have a higher limit because their weight is distributed differently). Similar signs are posted one half mile from the bridge, two tenths of a mile from the bridge, and at the foot of the bridge. Officer Joseph Barkas, a Department of Transportation Motor Carrier Compliance Officer, stopped Mr. Cran and prepared the Load Report and Filed Receipt describing the incident. The Respondent did not dispute that the truck was 17,100 pounds overweight, nor that the penalty for crossing the bridge based on that weight is $865, as shown on the Load Report and Field Receipt. Pettegrove Equipment disputes the fine because it's driver misunderstood the weight limit signs on the approach to the bridge. The silhouette of the straight truck is much shorter than the silhouette of the tractor trailer combination. Mr. Cran believed that the 26 ton limit for a straight truck applied to only small trucks, such as pickup trucks, and not to a large dump truck like the one he was driving. This contention is unpersuasive. Ordinary pickup trucks are incapable of carrying loads any where near 26 tons. Mr. Cran's interpretation is simply unreasonable. The limitations for straight trucks were clearly posted, and were violated.
Recommendation It is RECOMMENDED that a final order be entered by the Department of Transportation sustaining the fine of $865 assessed against Pettegrove Equipment. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 4th day of June 1992. COPIES FURNISHED: Vernon Whittier, Esquire Assistant General Counsel WILLIAM R. DORSEY, JR. 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 4th day of June 1992. Florida Department of Transportation Haydon Burns Building, M.S. 58 605 Suwannee Street Tallahassee, Florida 32399-0458 Ann Porath, Esquire Wellington Country Plaza Suite 209 12773 Forrest Hill Boulevard West Palm Beach, Florida 33414 Ben G. Watts Secretary Department of Transportation Haydon Burns Building, M.S. 58 605 Suwannee Street Tallahassee, Florida 32399-0458 Attn: Eleanor F. Turner Thornton J. Williams General Counsel Department of Transportation Haydon Burns Building, M.S. 58 605 Suwannee Street Tallahassee, Florida 32399-0458
The Issue Whether Respondent is guilty of violation Section 462.14(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the naturopathic physician's professional practice. Whether Respondent is guilty of violating Section 462.14.(1)(n), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient, S.N. Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by failing to perform a statutory or legal obligation placed upon a licensed naturopathic physician, by prescribing a controlled substance to patient S.N. not done in good faith or not done in the course of Respondent's professional practice. Whether Respondent is guilty of gross or repeated malpractice or failed to practice naturopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being appropriate under similar conditions and circumstances, in violation of Section 462.14(1)(t), Florida Statutes. Whether Respondent is guilty of exercising undue influence on the patient or client, S.N., in such a manner as to exploit the patient or client for the financial gain of the licensee, in violation of Section 462.14(1)(o), Florida Statutes. Whether Respondent is guilty of gross or repeated malpractice or failed to practice naturopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being appropriate under similar conditions and circumstances, concerning patients M.C.P., J.S. and M.A. for the following reasons: failure to perform an adequate physical examination or order appropriate tests; failure to adequately monitor the patient; failure to properly supervises the staff of MIWC; and, prescribing legend drugs inappropriately, in violation of Section 462.14(1)(t), Florida Statutes. Whether Respondent is guilty of violating Section 462.14(1)(n), Florida Statutes by failing to keep written medical records justifying the course of treatment of the patients, M.C.P., J.S. and M.A. Whether Respondent is guilty of violating Section 462.14(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, to patients M.C.P., and M.A. other than in the course of the naturopathic physician's professional practice. Whether Respondent is guilty of violating Section 462.14(1)(w), Florida Statutes, by delegating professional responsibilities to a person when the licensee delegating such responsibilities knows or has reason to know that such a person is not qualified by training, experience, or licensure to perform them. Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by allowing the dispensing of drugs not under his direct supervision. Whether Respondent is guilty of violating Section 462.14(1) (h), Florida Statutes, by failure to properly label medical drugs dispensed at the Island Weight Clinic (hereinafter, WIWC) Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by failure to make a complete and accurate inventory of all controlled substances on a biannual basis. Whether Respondent is guilty of violating Section 462.14(1) (1), Florida Statutes, by making deceptive, untrue, or fraudulent representations in the practice of naturopathic medicine by claiming the substance HCG is an effective adjunctive therapy in the treatment of obesity.
Findings Of Fact Many of the medicinal (legend) drugs dispensed at MIWC did not bear labels containing the following information: patient's name; date dispensed; directions for use; or, drug name or prescription number. On May 20, 1986, an inspection was conducted at MIWC. Respondent had not conducted an inventory of all controlled substances at the time at hand on a biannual basis. Respondent's standard practice in regard to new weight clinic patients is as follows: Height, weight, blood pressure and pulse are recorded and blood is taken. Respondent sees patients for about fifteen minutes for an initial examination and they are not seen again by him unless they have problems; each patient is instructed to take their own basal temperature. Patient's blood is checked for hemoglobin, uric acid, cholesterol and blood sugar only; Reports are examined by Respondent if Respondent feels it is needed; Respondent uses practically the same medication for everyone, including: Thyroid pills, HCG or lipotropics, Potassium glucanate, and Ionamin (brand name of phentermine). Vitamin B-6 Folic acid If the patient's blood pressure is elevated the clinic calls Respondent; Clinic staff orders the units of phentermine for delivery at MIWC and another diet clinic in Melbourne, Florida, and dispenses medicinal drugs without direct supervision. Respondent, during the period of time February 10, 1984 through July 1989, has ordered the following quantities of medicinal drugs and controlled substances: Phentermine 8 mg. 31,000 Phentermine 30 mg. 432,000 Phentermine 37.5 mg. 13,000 Thyroid 1/2 grain 1,243,000 Thyroid 1 grain 129,000 Thyroid 2 grain 72,000 HCG 422,000 Potassium 1,170,000 Respondent has provided to weight control patients a printed handout concerning the weight control program. Petitioner has not demonstrated by clear and convincing evidence that HCG is not an effective adjunctive therapy in the treatment of obesity.
Conclusions Based upon the Findings of Fact set forth above, it is concluded that Respondent has committed repeated malpractice and has failed to practice naturopathic 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 in regard to his treatment of weight clinic patients in violation of Section 462.14(1)(t), Florida Statutes. Respondent's medical records for the weight clinic patients are insufficient to justify the course of treatment of the patients. Therefore, Respondent has failed to keep written medical records justifying the course of treatment of the patients including, but not limited to, patient histories, examination results, test results, x-rays, and records of the prescribing, dispensing and administering of drugs, all in violation of Section 462.140(1)(n), Florida Statutes. Based upon the Finding of Fact above, it is concluded that Respondent has dispensed and administered legend drugs, including controlled substances, inappropriately. Based upon the presumption contained in Section 462.14(1)(q), Florida Statutes, Respondent has dispensed and administered legend drugs, including controlled substances other than in the course of his professional practice in violation of Section 462.14(1)(q), Florida Statutes. Former Section 465.027(2), Florida Statutes (1979), provided in pertinent part: Nothing in this Chapter shall be construed to prevent a practitioner authorized by law to prescribe medicinal drugs from compounding, dispensing, or giving such drugs to his patients in the regular course of his practice. Such compounding and dispensing may be done only by the practitioner himself and shall comply with all Federal and State Laws relating to the labeling and dispensing of medicinal drugs. The provisions of Section 465.027(2), Florida Statutes, were interpreted in two significant opinions. In Parr et al. v. Spires, 41 So.2d 36 (Fla. 1949), the Supreme Court held that a physician's employees, though not registered pharmacists, may lawfully for the doctor's own patients only, dispense, compound and sell any medicinal drugs, provided such dispensing, compounding and selling are done under the doctor's constant and immediate supervision and direction. In addition, in 1963 the First District Court of Appeal in Love v. Escambia County, 157 So.2d 205 (Fla. 1st DCA 1963) stated the language in Chapter 465, Florida Statutes, creating an exception for a physician "himself" dispensing is satisfied where the dispensing is done under the immediate supervision of a physician. The Court stated that the letter and spirit of the statutes is complied with where such dispensing is done under the immediate direction of the physician. In 1986, the Legislature deleted Section 465.027(2), Florida Statutes, and enacted Section 465.0276, Florida Statutes, which provides: A person may not dispense medicinal drugs unless licensed as a pharmacist or otherwise authorized under this chapter to do so, except that a practitioner authorized by law to prescribe drugs may dispense such drugs in the course of his practice in compliance with this section. A practitioner who dispenses medicinal drugs for human consumption for fee or remuneration of any kind whether direct or indirect, must: * * * (b) Comply with and be subject to all laws and rules applicable to pharmacists and pharmacies, including, but not limited to, this chapter, chapter 499 and chapter 893 and all federal laws and federal regulations. It is concluded, therefore, that the Respondent, as a practitioner authorized to prescribe medicinal drugs, (see Section 462.01, Florida Statutes) may dispense the drugs himself to his patients in the regular course of his practice provided he complies with all laws and rules governing the practice of pharmacy. Section 465.003(5), Florida Statutes, provides in pertinent part: "Dispense" means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or his agent. As an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription . . . and he shall certify that the medicinal drug called for by the prescription is ready for transfer. Rule 215-4.002(2), Florida Administrative Code, confirms the responsibility of the pharmacist, and therefore, the physician in the dispensing act and provides: (2) Pursuant to the direction of the licensed pharmacist, pharmacy technicians may assist the pharmacist in the preparation of the prescription. Such pharmacy technician functions include the typing of prescription labels on a typewriter or through entry in a computer system and the entry of prescription information or physician's orders into a computer system. The pharmacist, however, must complete the dispensing act and initial the prescription. Therefore, under both Section 465.027(2), Florida Statutes (1979) and Section 465.0276 (1987), Florida Statutes, Respondent was obligated to personally dispense or to certify that the medicinal drugs called for by the prescription were ready for transfer. In addition, Respondent was obliged to comply with all statutes and regulations governing the practice of pharmacy. Rule 215-1.013(1), Florida Administrative Code, is a rule of the Board of Pharmacy, applying to pharmacies and pharmacists. Said rule provides that labels of all non-controlled substances must include the following information: Name and address of the pharmacy; the name of the prescriber; the name of patient; the date of the original filling or refill date; the prescription number or other prescription information adequate to readily identify the prescription; the directions for use; and, the name of the medicinal drug dispensed (except where the health care practitioner prescribing the drug specifically denotes that the name is to be withheld). In addition, Section 893.05, Florida Statutes, provides in pertinent part: (2) When any controlled substance is dispensed by a practitioner, there shall be affixed to the original container in which the controlled substance is delivered a label on which appears: A date of delivery; the directions for use of the controlled substance; the name and address of the practitioner; the name of the patient; a clear and concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom it is pre- scribed. Rule 21S-1.014, Florida Administrative Code, requires that the prescription department be closed when a licensed pharmacist is not present. Therefore, no drugs can be dispensed in the absence of a licensed pharmacist. Likewise, this regulation would be applicable to dispensing practitioners. Respondent permitted staff members not licensed as pharmacists to dispense medicinal drugs, including controlled substances when he was not present, and had not certified the drugs as being ready for dispensing. In addition, the labels utilized by the Respondent did not meet the requirements of Florida law. Respondent has, therefore, violated the following: Respondent has delegated professional responsibilities to a person when he knew or had reason to know that such person was not qualified by training, experience, or licensure to perform them; to wit, dispensing of medicinal drugs and controlled substances, in violation of Section 462.14(1)(w), Florida Statutes. Respondent has failed to perform a statutory or legal obligation in violation of Section 462.14(1)(h), to wit, by allowing the dispensing of drugs other than under his direct supervision, or in violation of Section 893.05(1), Florida Statutes, and without proper labeling in violation of Florida Statutes and rules set forth above. Section 893.07, Florida Statutes, requires that all practitioners make a complete and accurate inventory of all controlled substances on hand on a biennial basis. Respondent failed to conduct the required inventories. Therefore, Respondent has violated Section 462.14(1)(h), Florida Statutes, by failing to perform any statutory or legal obligation placed upon a licensed naturopathic physician. Respondent has made representations concerning the effects of HCG as an effective adjunctive therapy in the treatment of obesity both verbally and in the printed handout provided to weight control patients on a routine basis. The representations contained in the handout and made to patients have not been shown to be deceptive, untrue or fraudulent, by clear and convincing evidence. Therefore, Respondent is not guilty of violating of Section 462.14(1)(l), Florida Statutes. It is concluded that Petitioner has established by clear and convincing evidence that Respondent has violated the provisions of Subsections 462.14(1)(h),(n),(q),(t) and (w), Florida Statutes. Section 462.14(2), Florida Statutes, provides in pertinent part: (2) When the department finds any person guilty of any of the grounds set forth in subsection (1), it may enter an order imposing one or more of the following penalties: (b) Revocation or suspension of license. (d) Imposition of an Administrative Fine not to exceed $1,000.00 for each count or separate offense.
Recommendation Based on the foregoing findings of fact, conclusions of law and the multiple and continuing violations as demonstrated, it is recommended: That the license of Jesse Alexander as a naturopathic physician be revoked and that an administrative fine of $4,000 be imposed. DONE AND ENTERED this 7th day of August, 1990, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 7th day of August, 1990. APPENDIX TO RECOMMENDED ORDER CASE NO. 89-6093 The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings of Fact: Accepted: Paragraphs 1, 2, 3, 4 (in substance), 5, 6, 7, 8, 9, 10, 11, 13 (in substance), 14, 15, 16, 17 (in part), 18, 19, 20, 21, 22, 24, 25, 25(#2), 26, 27, 28, 29, 30, 31, 33, 34, 35, 36 (in part), 37, 38, 46, 48, 49 (in substance) 51, 53 (in part) Rejected: Paragraphs 12 (conclusion of law), 23 (against the greater weight of the evidence), 32, 33, 39 through 44 (repetitious finding), 45 (conclusion of law), 47 (conclusion), 50 (conclusion), 52 (conclusion) 54 (against the greater weight of the evidence) Respondent's Proposed Findings of Fact: Respondent's proposals have been carefully reviewed and incorporated when supported by the evidence. However, Respondent's proposals, for the most part, are a recitation of the testimony of witnesses, documents in the evidence and argument. Therefore, findings of fact 2-4,6-60 are rejected. COPIES FURNISHED: Bruce D. Lamb, Esquire Chief Trial Attorney Department of Professional Regulation, Suite 201 730 S. Sterling Street Tampa, FL 33609 Steven J. Jacovitz, Esquire 43 S. Atlantic Avenue Cocoa Beach, FL 32931 Lawrence A. Gonzalez Secretary Department of Professional Regulation Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 Kenneth E. Easley General Counsel Department of Professional Regulation Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 =================================================================
The Issue The issue in this case is whether the alleged deficiency cited in the October 2001 survey report existed and, if so, whether the deficiency is sufficient to support the change in the Aristocrat's licensure status from standard to conditional.
Findings Of Fact The Agency is the state agency responsible for licensing and regulating nursing facilities in the State of Florida under Part II, Chapter 400, Florida Statutes. The Aristocrat (The Aristocrat or facility) is a nursing home located at 10949 Parnu Street, in Naples, Florida, licensed by and subject to regulation by the Agency pursuant to Part II, Chapter 400, Florida Statutes. The Agency conducted an annual survey of The Aristocrat from October 8 through 10, 2001. The results of the survey are summarized in a report known as the 2567 report. The 2567 report identifies each alleged deficiency by reference to a tag number (“Tag”). Each Tag of the 2567 report includes a narrative description of the alleged deficiency and cites the relevant rule or regulation violated thereby. The Tag at issue in this proceeding is Tag F 325. Tag F 325 relates to quality of care and references 42 C.F.R. 483.25(i)(l), which requires that, “[b]ased on a resident’s comprehensive assessment, the facility must ensure that a resident maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident’s clinical condition demonstrates that this is not possible.” The standard in 42 C.F.R. 483.25(i)(1) is made applicable to nursing homes in Florida pursuant to Rule 59A- 4.1288, Florida Administrative Code. The Agency is required to rate the severity of any deficiency pursuant to the classification system outlined in Section 400.23(7), Florida Statutes. The Agency assigned a Class II rating to the deficiency as well as “scope and severity” of G pursuant to federal law. The state classification is at issue in this case. A Class II deficiency is one which “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. When the Agency alleges that there is a Class II deficiency, as it did in this case, the Agency may change the facility’s licensure rating from standard to conditional. In accordance with its authority and discretion, based on the alleged Tag F 325 deficiency, the Agency changed The Aristocrat’s nursing home licensure rating from standard to conditional, effective October 10, 2001. During the October survey, an Agency surveyor reviewed the clinical records of six residents at The Aristocrat. The Tag F 325 deficiency was based on the Agency’s findings related to the records of one of those six residents and on interviews with facility staff. In order to protect the privacy of the nursing home resident who is the subject of the alleged deficiency, the Administrative Complaint, the 2567 report, and this Recommended Order refer to the resident by number rather than by name. As a result of the surveyors’ review of the records, the Agency determined that one of the residents, Resident 1, had a weight loss of 7.2 pounds between July 30, 2001, and August 11, 2001. The surveyors’ review of Resident 1’s records further reflected that she had a total weight loss of 13.5 pounds between July 30, 2001, and August 25, 2001. According to the resident’s weight records and nutritional assessment, which listed the resident’s usual body weight as 136 pounds, the surveyors considered the weight loss during the aforementioned periods to be significant. Once the surveyors concluded that Resident 1 had a significant weight loss, the surveyors had to determine whether the resident’s weight loss was avoidable. In making this determination, the surveyors had to determine whether the facility assessed the resident adequately, developed a care plan, implemented the care plan, and reevaluated the care plan. Applying the Agency’s protocol set forth in the above paragraph, the surveyors determined that the significant weight loss experienced by Resident 1 was avoidable. The Agency surveyors found that the facility failed to do the following: adequately assess and develop a plan of care to prevent Resident 1 from significant weight loss; assess and develop an adequate care plan after the resident had a significant weight loss of 5.3 percent of her body weight in less than two weeks; and adequately assess, evaluate and revise the care plan to address the resident’s significant weight loss of 9.9 percent of her body weight in less than a month. According to the 2567 report and the Administrative Complaint, the nutritional parameter that the Agency alleges the facility did not maintain for Resident 1 was weight loss. The Agency was concerned that Resident 1’s weight dropped from 136 pounds on July 30, 2001, to 128.8 pounds on August 11, 2001, which was a 5.3 percent loss of her body weight, upon admission to the facility. Also, the Agency was concerned that the resident’s weight dropped from 136 pounds on July 30, 2001, to 122.5 pounds on August 25, 2001, a 9.9 percent loss of her body weight, upon her admission to the facility. The Agency alleges that the failure to assess and develop an adequate care plan to address weight loss caused the referenced weight loss. Resident 1, a 92-year-old female, was admitted to The Aristocrat on July 30, 2001, at about 3:00 p.m. Her diagnosis included a left hip fracture, left shoulder fracture, atrial fibrillation, esophageal reflux, depression, bipolar disorder, hypertension, and chronic insomnia. John Patrick Lewis, M.D., was Resident 1’s treating physician at the time of and throughout her three-month stay at The Aristocrat. Upon Resident 1’s admission to the facility, Dr. Lewis had “great concern” about the resident’s atrial fibrillation because of her history of T.I.A.s (strokes). As a result of this concern, Dr. Lewis consulted with and reviewed the medical records of Dr. Drew, Resident 1’s primary physician. Resident 1's weight dropped from 136 pounds on July 30, 2001, to 134.8 pounds on July 31, 2001, to 133 pounds on August 4, 2001, to 128.8 pounds on August 11, 2001. Resident 1’s weight began to level off on August 15 or 16, 2001, when edema was no longer noted on her records. Thereafter, beginning on August 19, 2001, the resident’s weight began to stabilize. Resident 1 weighed 124.2 pounds on August 19, 2001; 122.5 pounds on August 25, 2001; 122.7 pounds on September 7, 2001; 121.2 pounds on September 14, 2001; 122.2 pounds on September 21, 2001; 121.6 pounds on September 28, 2001; and was 120.3 pounds on October 6, 2001. Resident 1 came to The Aristocrat days following major surgery of her hip after she suffered a fracture of her hip and shoulder. Resident 1 was hydrated with fluids prior to and/or during the operation to ensure that she maintained a good blood pressure. As a result thereof, at the time Resident 1 was admitted to The Aristocrat, she had an increased amount of fluids in her body and was over-hydrated. The over-hydration caused Resident 1 to have swelling, known as edema. Dr. Lewis testified that Resident 1's edema was actually third space fluids, which are fluids that go extravascularly into the soft tissues or into the peritoneal cavity. It typically takes a period of 7-14 days for that fluid to return to the intravascular compartment and then be urinated away. At the time of her admission at The Aristocrat and throughout her stay there, Resident 1 was on a medication known as Lasix, which is a diuretic that causes the body to urinate excess fluids. Lasix was included in Resident 1’s discharge orders from the hospital where she had surgery for her hip fracture and was never discontinued. In Dr. Lewis’ opinion, there was no need to discontinue the Lasix because the resident was never dehydrated during her stay at The Aristocrat. Moreover, Dr. Lewis is aware that in addition to being a diuretic, Lasix is sometimes prescribed for high blood pressure and this may have been another reason Lasix was included in the resident's discharge orders. The presence of edema in Resident 1 was clearly noted in her chart by facility staff at or near the time she was admitted to the facility. The reference to Resident 1's edema is included in the nurse’s notes dated July 30, 2001, nurse’s notes dated July 31, 2001, a registered dietician's note dated August 1, 2001, and a physical therapy note dated July 31, 2001. The nurse’s notes dated July 30, 2001, the date Resident 1 was admitted to the facility, state that “2 plus edema noted on left upper extremity.” Another document in Resident 1's chart, dated July 31, 2001, states, “2 plus edema on left hip, incision site.” The nutritional assessment dated August 1, 2001, two days after Resident 1 was admitted to the facility, notes edema in lower and upper extremities and “some weight loss expected.” Finally, a dietary note dated August 1, 2001, mentions Resident 1’s edema, but does not mention the location of the edema. The Aristocrat staff did not note Resident 1’s edema on her initial Minimum Data Set form (MDS) as preferred by the Agency. However, the resident’s edema was charted in several places in her records. The Agency’s surveyor acknowledged that Dr. Lewis saw Resident 1 on August 11, 2001, when her weight had dropped from 136 pounds to 128.8 pounds and did not instruct The Aristocrat’s staff to alter their approach to providing adequate nutrition to Resident 1. The reason Dr. Lewis did not order that any changes be made for Resident 1 on August 11, 2001, was that he believed that none were required or necessary in that “the majority of this weight loss was to be expected.” According to Dr. Lewis, “this weight loss [was] not unexpected due to her excessive hydration and third space fluids.” The Agency’s initial concern was Resident 1’s weight loss, during the period of July 30, 2001, through August 11, 2001, when she lost 7.2 pounds, or 5.3 percent of her weight at the time of her admission to the facility. Surveyors are instructed to use a resident’s “usual body weight” to make weight loss calculations. When calculating weight loss, the usual body weight is determined by considering the person’s weight through adult life. According to the state’s guidelines, an analysis of weight loss or gain should be examined in light of the individual’s former life style, as well as current diagnosis. The medical records of Dr. Drew, Resident 1’s primary physician, indicate that Resident 1 weighed 127 pounds on January 31, 2001, and weighed 125 pounds on June 8, 2001. In light of the undisputed fact that Resident 1 was over-hydrated at the time she weighed 136 pounds, it is reasonable to assume that her weight in the months and weeks prior to surgery would be more appropriate figures to use as the resident's usual body weight. Based on her 5'0" height, Resident 1's ideal weight was 100 pounds, the midpoint between the ideal weight range of 90 to 110 pounds for someone five feet tall. In fact, were 136 pounds Resident 1's true weight, she would be considered clinically obese. The Agency surveyor based his calculations that Resident 1 had a significant weight loss on the assumption that the resident’s usual body weight was 136 pounds. The surveyor obtained the 136-pound weight as the resident’s usual body weight from the facility’s nutritional assessment. The Aristocrat incorrectly listed the resident’s weight upon admission, 136 pounds, as her usual body weight. Even if it is assumed that the Agency reasonably relied on the facility’s records that note Resident 1’s usual weight as 136 pounds, the calculations using this weight are flawed because that is not Resident 1’s usual body weight. Had the Agency based its calculations relative to the resident’s weight loss on her usual body weight of 125 pounds, a drop in weight from 125 pounds to any of Resident 1's charted weights would not be “significant” according to surveyor guidelines. One can lose 10 pounds of water weight in just a couple of days but one must burn calories to lose body weight. There are 3,500 calories in a pound. Therefore, in order lose one pound of body mass, a person would need to burn 3,500 calories. Resident 1 lost one pound each day for the first three days she was at The Aristocrat. In order to lose three pounds of body mass, Resident 1 would need to burn 10,500 calories. At the time of her admission to The Aristocrat, Resident 1 was 92 years old and, for the first two weeks she was at the facility, was bed-bound, with a fractured hip and shoulder. Given Resident 1’s condition, it is reasonable to assume that she burned minimal calories. It was physiologically impossible for Resident 1 to lose true body weights in the amounts quoted in the 2567 report. Resident 1 dropped from 136 pounds down to 134.8 pounds the next day and then down to 133 pounds the following day. Because it is impossible to lose a pound of actual body weight in one day, the recorded weight loss for Resident 1 was too rapid to be true weight loss. Rather, the resident's initial weight loss was the result of a decrease in her edema. In determining that Resident 1 had a significant weight loss during the period of July 30 and August 11, 2001, the Agency surveyors based their calculations on an inaccurate usual body weight for the resident. Moreover, the Agency did not consider that the resident had edema and was taking Lasix, a diuretic, and that part of the weight loss could have been water weight. In fact, the 2567 report does not mention that the resident’s chart or records indicate that Resident 1 had edema and that a weight loss could be expected as the edema decreases. The Agency’s explanation for not doing so was that the facility’s records did not indicate or assess the amount of edema Resident 1 had upon her admission. Even though Resident 1 was edematous, the facility staff appropriately addressed her weight issues and immediately began implementing nutritional interventions. There are a number of complex factors at play in the selection and timing of appropriate interventions for a given resident. For example, there is a "warm-up time" to see how a new resident will adjust to the facility. It is not unusual for new residents to experience problems as a result of being in a new environment. However, after a couple of weeks, many of the new residents resolve their relocation issues and adjust to their new environment. During the period of July 30 through August 11, 2001, The Aristocrat’s staff engaged in numerous activities, which assessed Resident 1 from a nutritional standpoint, and immediately implemented interventions to enable her to maintain as much weight as possible. On July 31, 2001, the day after Resident 1 was admitted to the facility, the occupationa1 therapy staff evaluated Resident 1 to determine the level of supervision and set up assistance she needed while eating. On August 1, 2001, two days after Resident 1 was admitted to The Aristocrat, the facility’s registered dietician assessed Resident 1 and, as noted in paragraph 23, above, indicated that some weight loss would be expected as her edema decreased. That same day, the facility’s registered dietician reviewed some of the resident’s lab values that had been taken at the hospital from which Resident 1 had been released and also ordered a multi-vitamin for the resident. On August 2, 2001, the day after the registered dietician completed a nutritional assessment of Resident 1, the facility’s dietary manager met with Resident 1 to assess her food preferences and find out her likes and dislikes. During this meeting, the dietary manager learned that Resident 1 wanted coffee, with four packs of sugar, with all of her meals and a danish at breakfast. The danish is considered a specialty food and is not one usually provided on a daily basis to residents in nursing home facilities such as The Aristocrat. However, upon learning of Resident 1’s food preferences, the facility immediately began providing her with a danish with her breakfast each morning and coffee with four sugars with each meal. The facility’s providing Resident 1 with the foods she requested was an appropriate intervention that honored her preferences. The assessment described in paragraph 42 is consistent with the acceptable industry standard concerning nutritional issues of new residents. That standard requires facilities to analyze the resident for a number of days, determine their food preferences, and see if their nutritional and/or caloric needs can be met through food first. As such, using specialty foods such as a danish and coffee with sugar are appropriate interventions, which honored the resident's preferences. Two additional assessments were performed within a week of Resident 1’s admission to the facility. First, on August 5, 2001, a restorative assessment was completed which addressed Resident 1's ability to use utensils and open her food. The next day, the speech therapy unit of the facility completed a swallowing screening that assessed Resident 1's dysphagia and ability to swallow. Throughout the month of August, including August 11, 2001, and prior thereto, nurse’s notes regularly included information concerning Resident 1’s appetite, food intake, necessary and/or recommended interventions, and other nutritional issues. For example, prior to August 12, 2001, at least two nurse’s notes indicated that Resident 1’s appetite was fair and another nurse’s note indicated that her appetite was poor. Two of the nurse’s notes for this time period indicated that that the resident needed encouragement with oral intake. In addition to the aforementioned interventions implemented by The Aristocrat’s staff during August 2001, Dr. Lewis intervened numerous times with Resident 1. Because Resident 1's room was near the front of the facility, every time Dr. Lewis went into the facility he walked by her room and encouraged her to eat. Dr. Lewis also had numerous conversations with Resident 1's family to have them bring home cooked food that she would enjoy eating. To the extent that Resident 1 did not maintain “acceptable” parameters of nutritional status, the weight loss was attributable to Resident 1's clinical condition and not any failure on the part of The Aristocrat’s staff. In addition to Resident 1's having edema, she had other clinical issues that may have contributed to her weight loss. These clinical conditions involve the resident's behavioral and emotional problems and certain medication that the resident was taking to relieve the pain she was experiencing following her surgery. A person's behavior and emotional problems can have a considerable impact on the resident’s appetite and eating patterns. For example, a person, such as Resident 1, who suffered from depression and a bipolar disorder, may have a low appetite. In this case, Resident 1 suffered from depression and a bipolar disorder. These conditions may likely have been exacerbated by the resident's having to leave the assisted living facility in which she had lived prior to her surgery, going to a hospital for surgery, and, after being released from the hospital, having to be admitted to yet another nursing facility, The Aristocrat. Resident 1 exhibited behavior problems from the beginning of her stay at The Aristocrat, as documented in her records. During the first two weeks that Resident 1 was at the facility, staff of The Aristocrat documented some of the behaviors that the resident was exhibiting. The resident's MDS dated August 8, 2001, and the MDS dated August 13, 2001, indicate that Resident 1 was experiencing mood and behavior problems, on a daily basis, as reflected in her verbal expressions. Resident 1's August 5, 2001, Social Work Assessment Report indicated that Resident 1 made negative statements almost daily and wanted to return to the assisted living facility. The Social Work Assessment Report described the resident's medical conditions that interfered with her relationship skills as "sad mood, melancholy, anxieties, fear, [and] relocation issues." With regard to the resident's relationship involvement patterns, the report indicates that Resident 1 prefers solitude. The Social Work Assessment Report of August 27, 2001, confirmed that Resident 1 made negative statements almost daily and was anxious and angry. The assessment report also noted that Resident 1 was in an unpleasant mood in the morning almost daily, that Resident 1 withdrew from activities almost daily and exhibited reduced social interaction almost daily. The same document indicated that Resident 1 preferred solitude, and demonstrated a sad mood, melancholy, anxieties, fear, and relocation issues. The Behavior/Intervention Monthly Flow Chart Record for August 15 through August 31, 2001, indicates that Resident 1 yelled at staff and was uncooperative. Finally, the care plan priority document for Resident 1 dated August 30, 2001, indicated that her anxiety may be secondary to anger, that her anger was persistent, and that she was verbally abusive to staff. Undoubtedly, Resident 1's behavior and mood could have likely affected and inhibited her appetite, and, thus, contributed to some of the resident's weight loss. Yet, despite the facility’s documentation concerning the resident's behavioral issues, the Agency apparently did not consider either the documentation or the statements by facility staff during the survey that Resident 1's behaviors interfered with some of the attempted nutritional interventions. Another factor that may have contributed to the amount of food Resident 1 ate while at the facility was the medication she was taking. Resident 1 was on a regimen of Darvocet, a narcotic and pain medication, prescribed to help manage the pain she was experiencing as a result of the surgery and/or the hip and left shoulder fracture. Darvocet is a medication that inhibits a person's appetite. In this case, Resident 1 took approximately 30 doses of the narcotic pain reliever Darvocet during the first 10 or 12 days she was at The Aristocrat. Therefore, it is very likely that as a result of Resident 1's taking Darvocet, her appetite was inhibited and she ate less food than she may otherwise have eaten. The Aristocrat’s staff provided numerous interventions for Resident 1 during her first 21 days in the nursing home. They analyzed her weight and food intake through the dietary and nursing units. They offered to assist her with intake and encouraged her to eat. For example, CNA flow sheets for the month of August indicate that food and fluid were offered to Resident 1 approximately 10 times per day, usually five times during the 7-3 shift and five times during the 3-11 shift, every day. This was in addition to her regular meals, specialty foods such as coffee and danish and nutritional supplements. The snacks offered to Resident 1 were foods such as crackers and juice. Staff continually assessed Resident 1's needs and added interventions throughout her stay. A "significant change" MDS was completed on August 13, 2001, which related to Resident 1's percentage of meals eaten and weight loss. On August 14, 2001, The Aristocrat’s staff completed a behavior flow record that addressed Resident 1's uncooperativeness. On or about August 15, 2001, the facility developed a care plan for Resident 1 that included concerns about her weight loss after the initial weight loss due to resident’s loss of "water weight." The nutritional care plan included numerous approaches such as providing increased calories and encouraging intake of diet supplements and fluid. A nursing note of August 16, 2001, indicated that Resident 1's appetite was fair but improved to quite good while a note dated August 20, 2001, indicated that Resident 1 felt she was not getting good food. Staff discussed Resident 1's many dietary dislikes at a weight meeting on August 22, 2001. In order to increase the resident’s caloric intake, the dietary manager added ice cream to Resident 1’s diet at lunch and dinner. On or about August 23, 2001, Dr. Lewis ordered Medpass, a nutritional supplement, for Resident 1. Pursuant to the order, the resident had two 120cc of the supplement daily. Each 120cc of Medpass has 240 calories. Five days later, on August 28, 2001, Dr. Lewis increased the amount of Medpass Resident 1 was to receive from two 120cc of Medpass to four 120cc of Medpass each day. This order was immediately implemented. The goal of the nursing home is to provide 2,000 calories per day to a resident through food. After the first two weeks Resident 1 was at the facility, she consumed an average of 50 percent of her meals, which equaled approximately 1,000 calories per day. In addition, Resident 1 received 300 calories from her daily danish, 240 calories from her coffee with sugar, 300 calories from her daily ice cream, and 480 from Medpass, a nutritional supplement. This equaled an additional 1,020 calories from the “non-diet” portion of her food consumption and exceeded the 1,600 to 1,800 calories per day that Agency believed Resident 1 needed. The number of calories was increased an additional 480 calories, on or about August 28, 2001, after Resident 1 began receiving four 120cc of Medpass. The Agency alleged at hearing that the facility failed to ensure that Resident 1's estimated protein needs were being met. In determining a person's estimated protein needs, it is clinically appropriate to base such needs on the person's ideal weight. In light of that approach, Resident 1 would have needed approximately 59 grams of protein per day. The meal consumption estimates do not reflect whether the resident ate only one food item or a portion of each item. However, given that the resident's diet had approximately 100 grams of protein and that she consumed approximately 50 percent of her diet, it is reasonable to conclude that her protein needs were met. Most of the time Resident 1 was at the facility, she was eating “fair” which is generally considered that she was eating about 50-75 percent of her meals. Given Resident 1's consumption of her 2,000-calorie diet plus supplements, it is reasonable to conclude that she maintained adequate parameters of nutritional status. The Aristocrat’s staff began interventions for Resident 1 from the day she was admitted to the facility. The staff analyzed her needs and provided her with a supplementation of calories by August 1, 2001. Staff continually assessed Resident 1's needs and added additional interventions throughout her stay at the facility. Two of the more aggressive interventions included obtaining a psychological consultation for Resident 1 and ordering an appetite stimulant for her. The Agency indicated that The Aristocrat should have implemented these more aggressive interventions much earlier than it did in order prevent Resident 1 from losing weight. Contrary to this position, it is not likely that these interventions would have prevented the resident’s initial weight loss that occurred between July 30 and August 11, 2001, because the weight loss was water weight. Dr. Lewis waited until September 13, 2001, to order Megace for Resident 1 because he wanted to give other interventions a chance to work. Also, Megace is an appetite stimulant that can cause liver toxicity. Because of the known side effects of Megace, Dr. Lewis used this approach only as a “last-ditch alternative.” With regard to the psychological consultation, the facility delayed this intervention although the staff was aware of and had noted the resident’s behavior problems soon after she was admitted. The consultation was appropriately delayed to give the resident a chance to adjust to her new environment and to first attempt more conservative measures. Moreover, in this case, Dr. Lewis testified that he recalled that, initially, there may have been some opposition from Resident 1's family regarding a psychological consultation. Resident 1 maintained “adequate” nutritional parameters while at The Aristocrat. To the extent that she may not have maintained "adequate" nutritional parameters during the first almost two weeks at the facility, Resident 1's clinical condition made her initial weight loss unavoidable. Signs or symptoms that a person has been nutritionally compromised include the development of pressure sores and malnourishment, dehydration, dull eyes, and/or swollen lips. In this case, Resident 1 did not exhibit any clinical signs of malnourishment, dehydration, or pressure sores. Moreover, Resident 1 suffered no harm as a result of the initial or subsequent weight loss noted in the 2567 report. The Agency’s reason for changing the facility's licensure rating from standard to conditional is based on its conclusion that the weight loss experienced by Resident 1 was avoidable. The Agency's policy is that if there is an avoidable weight loss, there is harm, with or without a determination that there is actual harm to the resident. The credible testimony of Dr. Lewis was that Resident 1 recovered “very successfully from two major fractures, even in the setting of depression and advanced age.” At the end of Resident 1's stay at the facility she was ambulating on her own with a walker and performing some of her own activities of daily living; and after approximately three months in the facility, the resident returned to the assisted living facility where she previously lived.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order issuing a standard license rating to The Aristocrat and rescinding the conditional license rating. DONE AND ENTERED this 14th day of August, 2002, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 14th day of August, 2002. COPIES FURNISHED: Virginia A. Daire, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Dennis L. Godfrey, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310L St. Petersburg, Florida 33701 Michael S. Howard, Esquire Gallagher & Howard, P.A. Post Office Box 2722 Tampa, Florida 33602-4935
Findings Of Fact Respondent's Exception A.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception A.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception B. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception C. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception D. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception E. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.2. is GRANTED. There is no competent substantial evidence in the record to support the finding, "It has nothing to do with thinness or girth of the Chinese people." Since the burden of proof is on the Petitioner, a lack of evidence by the Respondent on a point cannot be, itself, the basis for a finding of fact against Respondent. Respondent's Exception F.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.5. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exceptions H.1. through H.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (first) is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (second) through I.5. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.2. through J.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.4. is REJECTED for the reasons stated in the arguments of the Petitioner. RULINGS ON EXCEPTIONS TO CONCLUSIONS OF LAW Respondent's Exception A.1. is REJECTED on the basis that the Hearing Officer's analysis is correct. The Board is authorized and required to rule on federal laws and rules, as well as Florida Statutes, such as Chapter 499, which set forth the requirements that licensed medical doctors must meet but which are not within the Medical Practice Act, Chapter 458, Florida Statutes. This Exception is also REJECTED based on the reasons set forth in the Petitioner's argument. Respondent's Exception A.2. is REJECTED based on the written argument of the Petitioner. Respondent's Exception A.3. is REJECTED based on the Department's oral argument and its written arguments to Exceptions A.1. and A.3. to the conclusions of law. Respondent's Exception B.1. is REJECTED based on the arguments set forth by Petitioner. Respondent's Exception C.1. is REJECTED for the reasons stated in the oral argument by the Petitioner and the written argument by the Petitioner in response to Exceptions in C.1 in Exceptions to Findings of Fact and C.1. in Exceptions to Conclusions of Law. Respondent's Exception D. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception E. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons set forth by the Petitioner. Petitioner's reliance on the Rodgers case is misplaced because that case involved full informed consent of the patients and did not involve fraud. Respondent's Exception F.2. through F.3. are REJECTED based on the reasons set forth by the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception set forth as "IV. SUMMARY" is REJECTED as cummulative. See Rule 21M-18.004, Florida Administrative Code. RESPONDENT'S EXCEPTION TO PENALTY 1. Respondent's Exception to penalty is REJECTED. PENALTY Upon a complete review of the record in this case, the Board determines that the penalty recommended by the Hearing Officer be ACCEPTED and ADOPTED. WHEREFORE, IT IS HEREBY ORDERED AND ADJUDGED that Respondent shall pay an administrative fine in the amount of $50,000.00 to the Executive Director within thirty days. Respondent's license to practice medicine in the State of Florida is SUSPENDED for a period of one year. Upon reinstatement from suspension, Respondent's license to practice medicine in the State of Florida is placed on PROBATION for a period of two years, subject to the special condition that Respondent pay $60,000.00 to the Department of Legal Affairs Division of General Legal Services, for use in consumer protection. This Order takes effect upon filing with the Clerk of the Department of Professional Regulation. DONE AND ORDERED this 17th day of August, 1989. BOARD OF MEDICINE FUAD S. ASHKAR, M.D. CHAIRMAN
Recommendation It is recommended that Dr. Willner be found guilty of ten counts of violation of the Medical Practice Act, that he be fined $50,000, and that his license be suspended for a period of one year, and that his licensure then be placed on probation for two years subject to the special condition that he pay $60,000 to the Department of Legal Affairs, Division of General Legal Services, for use in consumer protection. DONE and ORDERED this 7th day of June, 1989, in Tallahassee, Florida. WILLIAM R. DORSEY, JR. 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 7th day of June, 1989.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of allegations contained in a five-count Administrative Complaint. The charges against the Respondent may be summarized as follows: Count One charges the Respondent with violating Section 458.331(1)(h), Florida Statutes (1985) , by failing to perform any statutory or legal obligation placed on a licensed physician. Count Two charges the Respondent with violating Section 458.331(1)(1), Florida Statutes (1985), by making deceptive, untrue, or fraudulent representations in the practice of medicine when such scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community. Count Three charges the Respondent with violating Section 458.331(1)(n), Florida Statutes (1985), by failing to keep written medical records justifying the course of treatment of the patient. Count Four charges the Respondent with violating Section 458.331(1)(q), Florida Statutes (1985), by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. Count Five charges the Respondent with violating Section 458.331(1)(t), Florida Statutes (1985), by gross or repeated malpractice, or the failure to practice medicine with that level of care, skill, or treatment which is recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. The Respondent filed an answer to the Administrative Complaint. In his answer, the Respondent admits some of the factual allegations in the Administrative Complaint, but denies all allegations of wrongdoing. Following the hearing, a transcript of the proceedings at hearing was filed on September 16, 1987, and the parties were allowed fifteen days from that date within which to file proposed recommended orders. The Respondent filed a proposed recommended order on October 1, 1987, and the Petitioner filed one on October 2, 1987. Careful consideration has been given to the parties' proposed recommended orders, and specific rulings on all findings of fact proposed by the parties are contained in the Appendix which is attached to and incorporated into this recommended order.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME0004527. Respondent's last known address is 463 Emerald Road, Ocala, Florida 32672. Ionamine is a brand name for a scheduled controlled substance as defined by Chapter 893, Florida Statutes. Respondent's treatment of patients for obesity included B-12 vitamin injections. Approximately two-thirds of the Respondent's practice is devoted to the treatment of obesity. The other third of the Respondent's practice is devoted to a general practice of medicine. The Respondent graduated from Indiana University Medical School in 1945, interned in 1946, and became licensed in the State of Florida in 1951. The Respondent served for two years in the Air Force during the Korean War, and then returned to Florida where he established a practice in Miami. He practiced in Miami until 1970, at which time he moved to Ocala, where he has practiced since 1970. The Respondent is a board certified anesthesiologist and graduated at the top 10 percent of his class from Indiana University. The Respondent subscribes to and reads many medical journals and articles, including those concentrating on bariatrics. The Respondent has purchased and reviewed the American Medical Association video and study guide concerning the treatment of obesity. The Respondent also has continued his post graduate studies. When a new patient comes to the Respondent's office for treatment for obesity, the patient is first given a questionnaire to fill out. Subsequently a medical history is obtained from the patient, and the patient is given a thorough physical examination. Usually, but not always, blood and urine samples are obtained from this patient for testing, and the patient is given an EKG. If this patient appears to be in good health, the Respondent puts the patient on a weight loss program consisting of a reduction of calories, an exercise program consisting of a thirty minute walk each day, and an appetite suppressant, usually Phentermine or Diethylpropion. Phentermine and Diethylpropion are both helpful in the treatment of obesity. The Respondent also encourages each patient to take a vitamin injection on a weekly basis, regardless of whether there is any evidence of vitamin deficiency or pernicious anemia. Thereafter, the patient is instructed to return to the Respondent's office once a week, at which time an R.N. or L.P.N. checks their blood pressure, pulse, respiration, and weight. The nurse questions each patient to find out how they are reacting to the weight loss program. If everything appears to be satisfactory, the patient receives another seven-day supply of diet suppressant medication and a vitamin injection. The Respondent sees the patient every fourth visit (once a month) to determine what progress the patient is making. The Respondent routinely commences treatment of obesity patients, including the prescription of or dispensing of Phentermine or Diethylpropion, before reviewing the results of blood and urine tests. The Respondent continues obesity patients on an appetite suppressant (usually Phentermine or Diethylpropion) at the rate of seven 30 mg. pills per week as long as the patient continues to lose one percent of their body weight per week until their ideal weight is reached. In January of 1986, the Respondent saw a patient by the name of Sandy Wilson who came to his office for the treatment of obesity. The Respondent gave Ms. Wilson a thorough physical examination. The Respondent also questioned Ms. Wilson about her medical history. During the course of relating her medical history, Ms. Wilson complained of swelling of her hands and feet. The Respondent did not obtain blood or urine samples from Ms. Wilson, nor did he do an EKG on Ms. Wilson. Following his examination of Ms. Wilson, the Respondent placed her on a 1000 calorie per day diet, recommended that she exercise by walking 30 minutes each day, and dispensed to her a seven-day supply of Ionamine, which is a form of Phentermine. The Respondent also wrote a prescription for Ms. Wilson for thirty tablets of Furosemide 40 mg. Furosemide is a rather potent diuretic. The Respondent also suggested that Ms. Wilson have a vitamin injection, but she refused the injection. Ms. Wilson also refused to have blood drawn, saying she was afraid of needles. The Respondent told Ms. Wilson if she changed her mind she could have the blood drawn and the vitamin injection on her next visit. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not contain sufficient information to show that Ms. Wilson received a thorough physical examination. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not show that an adequate medical, social, or family history was obtained from Ms. Wilson. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not mention that Ms. Wilson had or complained of edema. The Respondent's records of Ms. Wilson's treatment during January of 1986 do not contain the results of any blood or urine tests or the results of any EKG. Ionamine and Furosemide should not be dispensed or prescribed to a patient for obesity and edema without first giving the patient a thorough physical exam, obtaining an adequate medical history, and obtaining the results of laboratory analysis of blood and urine samples and obtaining an EKG. This is in part because a patient may have the beginnings of some illness, such as diabetes or hypothyroidism, that are not detectable by a physical examination alone. The dispensing of Ionamine and the prescription of Furosemide to Ms. Wilson without first obtaining the results of laboratory analysis of blood and urine samples and obtaining an EKG is a failure to practice medicine with that level of care, skill, and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. A physician's records must be sufficient to justify the treatment given to the patient. In particular such records should contain complete information regarding examinations, histories, and laboratory tests. Because the Respondent's records regarding Ms. Wilson did not contain complete information in this regard, the Respondent has failed to keep written medical records justifying the course of treatment of the patient. Vitamin injections do not have any direct therapeutic effect in the treatment of obesity. They do not cause weight loss, nor do they contribute to weight loss. Nevertheless, periodic vitamin injections are commonly given to patients who are being treated for obesity as a form of "behavior modification." The goal of the behavior modification is to have the patient return for follow- up treatment on a regular basis. Vitamin injections do not pose any significant risk to the patient.
Recommendation Based on all of the foregoing, it is recommended that the Board of Medicine issue a final order in this case to the following effect: Dismissing Counts One and Two of the Administrative Complaint; Finding the Respondent guilty of the violations charged in Counts Three, Four, and Five of the Administrative Complaint; and Imposing the following penalty on the Respondent: (1) an administrative fine in the amount of one thousand dollars ($1,000.00), and (2) placement of Respondent's license on probation for a period of two years under conditions to be prescribed by the Board. DONE and ENTERED this 4th day of February, 1988, at Tallahassee, Florida. MICHAEL M. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of February, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-2031 The following are my specific rulings on all of the findings of fact proposed by the parties. As the parties are well aware, there is a large amount of conflict in the testimony in this case, especially in the expert witness testimony. To the extent that the testimony of the expert witnesses on behalf of the Petitioner (Dr. Clark and Dr. Weiss) conflicts with the testimony of the expert witnesses on behalf of the Respondent (Dr. Haimes and Dr. Asher), I have for the most part been persuaded by, and have incorporated into the findings of fact, the version set forth by the Petitioner's witnesses. Among other things, the version set forth by the Petitioner's expert witnesses more often appeared to be more logical, more reasonable and well reasoned, and more consistent with other evidence in the case. Findings proposed by the Petitioner: Paragraph 1: Accepted. Paragraph 2: Accepted in substance, with some irrelevant details deleted. Paragraph 3: Accepted in substance with some additional findings in the interest of clarity and accuracy. Paragraphs 4 and 5: Accepted. Paragraphs 6 and 7: Accepted in substance with additional clarifying details. Paragraph 8: Rejected as not fully supported by competent substantial evidence. Paragraphs 9 and 10: Accepted in substance with additional clarifying details. Paragraph 11: Accepted. Paragraph 12: Rejected as not supported by persuasive competent substantial evidence. Paragraph 13: Accepted. Paragraphs 14 and 15: Rejected as constituting argument rather than proposed findings of fact. (The failure to include argument in the findings of fact is not a comment upon the merits of the argument.) Paragraphs 16 and 17; Accepted in substance. Findings proposed by the Respondent: By way of clarification of some of the rulings which follow, it is noted that a substantial number of the findings proposed by the Respondent begin with the words "Dr. So-and-so testified" or the words "Dr. So-and-so believes." Such findings are, in most cases, nothing more than summaries of the testimony and might well have been rejected on that basis alone. However, I have chosen to direct attention to the substance of such proposals, overlooking their form, and have treated each such proposal as a proposed finding of the fact testified to or the fact believed by the witness. Accordingly, when such proposals are rejected as being contrary to the greater weight of the evidence, that is not to say that the witness did not so testify or did not so believe, but that the fact testified to or believed by the witness is contrary to the greater weight of the evidence. Paragraphs 1, 2, 3, 4, and 5: Accepted. Paragraph 6: Most of this paragraph has been accepted, but many of the statements have been made subject to additional qualifications to be fully consistent with the evidence. Some details have been omitted as not supported by competent substantial evidence. A major qualification is that the procedures described in this paragraph are performed on many, but not all, of the Respondent's patients. Paragraph 7: Rejected as subordinate and unnecessary details. It has already been found that the Respondent gives thorough physical examinations. Paragraph 8: Accepted. Paragraphs 9 and 10: Rejected as irrelevant. Paragraph 11: Accepted in substance. Paragraph 12: First sentence is accepted in substance. Second sentence is rejected as constituting an opinion which is contrary to the greater weight of the evidence. Paragraphs 13 and 14: Rejected as constituting subordinate and unnecessary details. Paragraph 15: Rejected as constituting subordinate and unnecessary details. Also, last clause of first sentence is not supported by competent substantial evidence. Paragraph 16: Rejected as constituting subordinate and unnecessary details. Paragraph 17: Rejected as irrelevant. Paragraphs 18, 19, 20: Rejected as irrelevant and as constituting subordinate and unnecessary details. Paragraph: 21: Rejected as subordinate and unnecessary details. Also rejected as inaccurate because there were other reasons for the opinion. Paragraphs 22, 23, 24, 25, 26, 27, and 28: Rejected as irrelevant. Paragraph 29: First two sentences rejected as subordinate and unnecessary details. Third sentence rejected as irrelevant because it ignores and omits the context of the statement. Paragraph 30: Rejected as unnecessary. Paragraphs 31 and 32: Accepted in substance with additional clarifying details. Paragraph 33: Rejected because an important detail of the proposal is not supported by competent substantial evidence. Paragraph 34: Rejected as not supported by competent substantial evidence and as contrary to the greater weight of the evidence. Paragraphs 35 and 36: Rejected as irrelevant. Paragraph 37: Rejected as contrary to the greater weight of the evidence. Paragraph 38: Rejected as subordinate and unnecessary details. Paragraph 39: Rejected as irrelevant and as subordinate and unnecessary details. Paragraph 40: Rejected as irrelevant. Paragraph 41: Rejected as subordinate and unnecessary details, because Dr. Haimes did not witness the examination and treatment of the patient. Paragraph 42: Rejected as irrelevant. Paragraph 43: Rejected because the witness's use of vitamin injection is irrelevant in light of other evidence and because the witness's opinion that vitamin injections are acceptable world wide is rejected as not persuasive. Paragraph 44: Rejected as contrary to the greater weight of the evidence. Paragraph 45: Rejected as irrelevant; the witness's beliefs notwithstanding, the greater weight of the evidence is to the contrary. Paragraph 46: Rejected as subordinate and unnecessary. Paragraph 47: First three sentences rejected as irrelevant. Last sentence rejected as contrary to the greater weight of the evidence. Paragraph 48: Rejected as contrary to the greater weight of the evidence. Paragraph 49: The first, second, and fourth sentences are rejected as contrary to the greater weight of the evidence. The third sentence is rejected as irrelevant. Paragraph 50: Rejected as contrary to the greater weight of the evidence. Paragraph 51: First two sentences rejected as contrary to the greater weight of the evidence. Last sentence accepted in substance. Paragraph 52: First sentence is rejected as contrary to the greater weight of the evidence. Second sentence is accepted in substance. Third and fourth sentences are rejected as subordinate and unnecessary details. Paragraph 53: First sentence rejected as irrelevant. Second sentence rejected as contrary to the greater weight of the evidence. Paragraph 54: Rejected as contrary to the greater weight of the evidence. Paragraph 55: Rejected as irrelevant. Paragraph 56: First sentence is rejected as contrary to the greater weight of the evidence. The second sentence is rejected as irrelevant. Paragraph 57: Rejected as subordinate and unnecessary. Paragraph 58: Rejected as contrary to the greater weight of the evidence. Paragraph 59: Rejected as subordinate and unnecessary details. Paragraph 60: Rejected as contrary to the greater weight of the evident. Paragraph 61: Rejected as irrelevant. Paragraph 62: First two sentences rejected gas contrary to the greater weight of the evidence. Third sentence accepted in substance. Last sentence rejected as irrelevant. Paragraph 63: First sentence rejected as irrelevant. Second sentence accepted in substance. Third sentence rejected as contrary to the greater weight of the evidence. Paragraph 64: Rejected as irrelevant. Paragraph 65: Rejected because the opinions in this paragraph are contrary to the greater weight of the evidence. Paragraph 66: First and third sentences rejected as subordinate and unnecessary details. Second and fourth sentences rejected as contrary to the greater weight of the evidence. Paragraph 67: Rejected as contrary to the greater weight of the evidence. Paragraph 68: Rejected as irrelevant. Paragraphs 69 and 70: Rejected as contrary to the greater weight of the evidence. Paragraph 71: Rejected as subordinate and unnecessary details. COPIES FURNISHED: Francine C. Landau, Esquire Inman and Landau, P.A. 2252 Gulf Life Tower Jacksonville, Florida 32207 H. Edward Dean, Esquire 201 Northeast Eighth Avenue Suite 100 Ocala, Florida 32670 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Ms. Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
