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BOARD OF MEDICINE vs. EDUARDO G. ROMERO, 87-005055 (1987)
Division of Administrative Hearings, Florida Number: 87-005055 Latest Update: Aug. 18, 1989

The Issue The issues in this case concern an administrative complaint placed by the Department of Professional Regulation against Eduardo G. Romero, M.D., Respondent in this cause for his treatment of two patients for weight control. Those patients are D.H., and S.T. who presented herself to Respondent as patient In his treatment of these patients, Respondent, at count one, is said to have violated Section 458.331(1)(t), Florida Statutes, by gross and repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Further, he is said at count two to have violated Section 458.331(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including a controlled substance, other than in the course of the physician's professional practice. A third count in the administrative complaint was dismissed at the commencement of the hearing and is not to be considered. Finally, in the fourth count, Respondent is said to have violated Section 458.331(1)(n), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient.

Findings Of Fact Respondent at all times pertinent to the administrative complaint was licensed as a physician by the State of Florida and continues to hold that license at present. In 1985 Respondent discontinued his family medicine practice and started a practice for treating patients for obesity and weight control. He purchased the obesity and weight control practice from a Dr. Scheininger. The obesity and weight control practice was conducted in the area of Jacksonville, Duval County, Florida. As a part of this practice, on occasion, Respondent would treat persons for minimal weight loss who could not be perceived as typical of the patients that he saw in his practice, nor can they be said to have been overweight and certainly not obese. In the conduct of his weight control practice, Respondent had one other person in his employ. That person was Diane Lee Smith, medical assistant. Ms. Smith's duties involved answering the telephone, writing certain basic information on patient's charts, laboratory testing, and the conduct of EKGs, and helping Respondent in his consultations. She also would take blood pressure readings from patients, pulse rates, take their weight and height and certain measurements of the patients' arms, waists, hips and upper thighs. Respondent in his practice would discuss the nature of his diet program, and do a physical examination to include checking pulse, monitoring heart rate and observing the fundi. If the patient upon those basic clinical observations seemed to need a more complete examination, he would order blood tests, urinalysis, and an EKG. In dealing with the patients, he had these patients provide certain information concerning health history, dietary habits and any exercise regimen that the patients participated in. Respondent did not take on the treatment of patients who had significant past medical histories. Respondent would speak to his patients individually and in a group concerning his weight control program. In these conversations he spoke to them about dietary habits, exercise habits and on occasion, would employ medication as a means of assisting in weight control. One of the drugs of choice by the Respondent in his treatment was Phendimetrazine. This is an anorexic that can be, used for a short duration as an appetite suppressant. It has a potential for abuse, but only in the instance when it is over- prescribed does it present the risk of addiction. The patients who used Phendimetrazine could gain a tolerance to it, thereby needing increasing dosages to profit from the pharmacologic effect. That phenomenon develops less quickly than with amphetamines. D.H., who had been a patient of Dr. Scheininger and had received diet pills from him to treat her weight condition, by a means which is not clear in the record, was contacted about further treatment for her weight condition. The lack of clarity concerns the matter of whether the contact was through Dr. Scheininger or Respondent's offices. Nonetheless, she arranged with the Respondent's office for an appointment to address her desire to lose a minimal amount of weight. This appointment was at the instigation of the Department of Professional Regulation, who upon complaint of the activities of Respondent, utilized D.H. as a means of investigation. The appointment took place on February 26, 1986. Her explanation of her reason for being at Respondent's office, as given to Respondent, was to the effect that she felt she needed to employ the assistance of a physician to lose some weight for cosmetic purposes. Certain entries made by Respondent and his assistant, Ms. Smith, concerning the February 26, 1986 visit and a subsequent visit on April 9, 1986, may be found in the Joint Exhibit No. 1 admitted into evidence. It also includes information provided by D.H. in the form of a medical information questionnaire. It includes dietary information as well. In the course of the initial visit of February 26, 1986, Respondent discussed D.H.'s dietary and exercise habits and suggested approaches about diet. D.H. is a woman of five foot two and a half inches tall, whose birthdate is August 18, 1947. At the time of her visit, her weight was somewhere in the range of 117 to 122 pounds. The doctor's office scale showed her to be 122 pounds. Any one of these weights were within the Metropolitan Life Insurance Company tables of what is considered to be normal weight for a woman of this height. On February 26, 1986, in the course of the visit Respondent checked the heart rate and examined the fundi and made records of these observations. No entry was in the record concerning blood pressure. Having considered the testimony it is found that the blood pressure was taken but no medical record was made of that blood pressure reading. No tests were ordered such as EKG, blood sugar, cardiac testing, blood count, urinalysis, liver and kidney studies, nor was the patient given a complete physical examination. These things were not done because Respondent was persuaded that the patient was a person who enjoyed good health and to undertake these steps would be extravagant and unnecessary. In discussion with the patient D.H. the impression was given to the Respondent that the patient had not succeeded in trying to control her weight to her satisfaction by exercise and diet. As a consequence, Respondent decided to prescribe Phendimetrazine. On February 26, 1986, D.H. was given a prescription of 35 mg. tablets, 60 in amount. The exact details of the explanation of the use of this medication by D.H. and its possible side affects is somewhat sketchy. However, enough is known to conclude that the Respondent made some explanation. He did not make a written entry in the medical records of the patient to the effect that he had explained how to use this medication and the possible complications in its use. Neither did he make those entries following his prescribing of Phendimetrazine, 105 mgs., 30 tablets, as a part of the April 9, 1986 visit by D.H. On the April 9, 1986 visit, basically the same procedures were followed in terms of weight which was shown on the chart as 117 pounds, heart rate and on this occasion, blood pressure was recorded. There is a note that the patient D.H. runs three to six miles three times a week. Respondent charged D.H. $50 for each visit. The medication which she obtained was turned over to the Department of Professional Regulation. As part of the Department of Professional Regulation's investigation of the Respondent, it utilized the services of S.T., who presented herself to the Respondent as patient B.B. S.T. is a Jacksonville deputy sheriff. Her visit with the Respondent occurred on April 21, 1986, and followed the basic sequence related to the prior patient D.H. A copy of certain information pertaining to the patient S.T. as kept by the Respondent may be found at Joint Exhibit No. 2, admitted into evidence. It reflects that this patient is five foot five inches tall, and at the time of the visit weight 128-1/2 pounds, which again is within the Metropolitan Life Insurance Company tables of appropriate weight for a woman of that height. Certain measurements were made of her waist, hips, arm and upper thigh, her blood pressure was taken, heart rate and fundi. Information was given by her concerning her health condition and dietary habits. Respondent, through his office, provided dietary information to this patient as with patient D.H. Patient B.B. was a patient who enjoyed good health and who was there to seek the assistance of the Respondent for purpose of losing a few pounds so that her clothes would fit her better, according to her explanation. No evaluative actions were taken other than those items presented in the aforementioned exhibit. As with D.H., Respondent was convinced that no further testing was needed for a patient who, by his clinical observation, appeared healthy. Phendimetrazine was prescribed for this patient in the amount of 105 mgs., 30 tablets. The explanation of the use of this medication was as is described before with the patient D.H. Respondent charged S.T. $50 for the visit. As with D.H., Respondent discussed dietary practices and the need for exercise with S.T. at length. S.T.'s comment to the Respondent was that she had not been able to lose the weight that she desired by her attempts at diet and exercise. In response, Phendimetrazine was prescribed to aid in this attempt. The Phendimetrazine for the two patients was not only prescribed by Respondent, it was dispensed by him. In addition to Respondent's testimony about the propriety of his treatment of the two patients, several other physicians, who are licensed in Florida offered their opinions. Dr. Stanley Weiss, who is a Board Certified Bariatric Physician testified for the Petitioner. Dr. Samuel J. Alford, Jr. and Dr. Kenneth Lasseter offered testimony for the Respondent. Dr. Weiss indicated that he does not consider the need for cosmetic weight loss to be a medical problem per se. In addition, he stated that he would not have taken on the treatment of D.H. and S.T. who did not have medical problems. Dr. Weiss in a significant portion of his practice treats patients who clearly suffer from problems of obesity. Consequently, when he gives the opinion that in every case of weight control a battery of tests involving EKG, blood sugar, cardiac testing, blood count, urinalysis, liver and kidney studies and a complete physical should be pursued, he is referring to a class of patients different from the patients in this case, by the history of Dr. Weiss' practice. In essence, Dr. Weiss is stating that it was inappropriate for the Respondent to take on the patients and treat them when the patients did not need medical attention and at the same time is stating that a series of tests should have been employed which are common to the treatment of the truly obese patient. This runs contrary to the opinion of the Respondent and of Drs. Alford and Lasseter who do not feel that the tests were in order for persons who by clinical observation, seem to be healthy. The opinion of the Respondent and Drs. Alford and Lasseter concerning the necessity of testing is the more appropriate choice on this occasion and it was not a violation of community standards or failure to practice medicine with reasonable care for the Respondent to fail to conduct the tests that have been alluded to in the rendition of facts. Dr. Weiss believes it was violative of community standards and failure to practice medicine at an acceptable level for Respondent to prescribe Phendimetrazine for the two patients in the instances set out in these facts. The use of Phendimetrazine, according to Dr. Weiss, for these patients who were not obese, is a failure to appropriately prescribe medication. His opinion is accepted. Respondent and Drs. Alford and Lasseter believe that the use of Phendimetrazine for the two patients was appropriate. Their opinion is not accepted. The fact that the two patients indicated that they had not achieved success by diet and exercise does not alter the impression of the facts and deference being paid to Dr. Weiss on the issue of the use of Phendimetrazine. It was not inappropriate for Respondent to consult with the patients D.H. and S.T. about their perceived problems. It was inappropriate to prescribe Phendimetrazine to gain a cosmetic result in an instance where there was no medical reason to utilize that legend drug. This fact is as supported by remarks of Dr. Weiss. Dr. Weiss is critical of the Respondent's medical records, in that they do not note that Respondent explained the possible side effects of the use of Phendimetrazine, and as they are lacking in an explanation of the ongoing or continuing care and in the absence of the aforementioned tests that Dr. Weiss would have conducted on the patients. That latter circumstance is not so much a failure to keep records as an allegation of failure to practice. If the tests were not done, it is to be expected that no record would have been made of the tests. Moreover, the tests were not indicated. Respondent and Drs. Alford and Lasseter do not find Respondent's recordkeeping to be inadequate. Having considered the issue of the need to record side effects or to put more information in the record concerning ongoing and continuing care, it suffices that some explanation of side effects was made and it is not necessary to make a written indication that the explanation was given to the patients. The general nature of the care and treatment of the patients is known by reference to the records. The only failure of recordkeeping which is significant is the failure to have recorded the blood pressure reading on D.H. in her visit of February 26, 1986. This constitutes a failure to keep a written medical record of an examination result.

Recommendation Based upon the findings of fact and conclusions of law reached, it is RECOMMENDED: That a Final Order be entered which dismisses Count III, and finds the Respondent guilty of violations as alleged in Counts I, II and IV, for which, in keeping width disciplinary guidelines, his license shall be suspended for a period of 30 days and he shall be directed to attend at least 21 continuing medical education course credits concerning appropriate drug prescribing unrelated to requirements for license renewal. DONE and ENTERED this 18th day of August, 1989, in Tallahassee, Leon County, Florida. CHARLES C. ADAMS 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 18th day of August, 1989. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 87-5055 The following discussion is given concerning the proposed facts of the parties: Petitioner' s Facts Subordinate to facts found. Accepted with the exception that reference to the necessity of conducting various tests is contrary to facts found. Not necessary to the resolution of the dispute. Subordinate to facts found. Contrary to facts found. Subordinate to facts found. Respondent' s Facts 1.-16. Subordinate to facts found. 17,18. Are not accepted to the extent of indicating that D.H. only went there for purposes of diet pills and presented herself as only wanting diet pills is contrary to facts found, otherwise they are acceptable. 19.-21. Subordinate to facts found. Constitutes the reasoning which Respondent would have trier of fact employ to arrive at facts and is not fact finding, with exception of reference to the fact that there is no notation in the chart that D.H.'s blood pressure was taken on February 26, 1986. Same response as prior paragraph. 24,25 Subordinate to facts found. 26. Unacceptable. 27.-41. Subordinate to facts found. 42. Not necessary in its first sentence and the second sentence is contrary to facts found. 43.-46. Constitute a discussion of the testimony and not fact finding. The overall conclusions of these physicians has been reported in the fact finding in the Recommended Order. 47. Further discussion of the opinion of the witness, Dr. Weiss, and is not fact finding. The balance of that paragraph deals with the claim that the Respondent instructed the patients to return in one week which is not accepted. Nor is the conjecture of what the patient S.T. intended to do on her visit to the Respondent. Finally, the remarks attributable to Dr. Alford are again the discussion of the testimony and not fact finding. 48,49. Subordinate to facts found. COPIES FURNISHED: Joseph Harrison, Esquire Department of Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold M. Braxton, Esquire 9100 south Dadeland Boulevard One Datran Center, Suite, 406 Miami, Florida 33156-7815 Kenneth D. Easley, Esquire Department of Professional Regulation 1940 North Monroe Tallahassee, Florida 32399-0792 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0735

Florida Laws (2) 120.57458.331
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FLORIDA POLICE BENEVOLENT ASSOCIATION, ET AL. vs. DEPARTMENT OF HIGHWAY SAFETY AND MOTOR VEHICLES, 78-001680RX (1978)
Division of Administrative Hearings, Florida Number: 78-001680RX Latest Update: Nov. 08, 1978

Findings Of Fact Petitioner McGowan was dismissed from his position as State Trooper by Respondent by letter dated 31 January 1978 (Composite Exhibit 1) which recites that the action in dismissing Petitioner is based upon Petitioner's violation of General Order No. 43 2.1C, Insubordination, third offense, and Rule 22A- 7.10(7)(a) Florida Administrative Code. McGowan was advised of his right to file a grievance pursuant to the agreement between Florida and the PBA or appeal the dismissal to the Career Service System. McGowan opted for the former and during the course of that hearing raised the issue before the Arbitrator that G.O.'s 40 and 43 were rules and invalid because not promulgated as required by Chapter 120 Florida Statutes. Respondent contested the jurisdiction of the Arbitrator to resolve this question, the parties stipulated that this issue be submitted to DOAH for determination, and the Petition here involved was filed. G.O. 40 relates to physical fitness of members of the Florida Highway Patrol and, after pointing out that weight control is an important part of physical fitness, provides in pertinent part: Members shall maintain control of their weight in relation to their height, age, and body build. There are several charts and tables available indicating the ideal or desirable weight based on the above factors. The maximum allowable weight by height for all ages and body builds for the members of the Florida Highway Patrol shall be those used by the Federal Bureau of Investigation. See G.O. 41, Appendix A. Exception to the maximum limits may be made for members who have a large amount of muscle weight (without excessive fat) and a physician certifies that the individual is not overweight due to excess fat. Failure to comply with the maximum weight limits will result in a low rating for personal appearance on the employee evaluation form and disciplinary action may be taken for violation of this regulation, as provided in G.O. 43. G.O. 43 contains guidelines for establishing standards of disciplinary actions and for appeals to the Career Service Commission. Guidelines for disciplinary actions are contained in Section 2.1 of G.O. 43 which provides in pertinent part: C. Guidelines: The following guidelines are established to insure that all supervisors are being reasonably consistent in taking disciplinary actions against employees involved in similar situations. These guidelines may be expanded or modified from time to time to meet changing conditions and to make their use more effective. They shall be followed generally; however, it is realized that some of the offenses and deficiencies will be more frequent in some cases, and the supervisor may take or recommend another course of action. In no case will these guidelines be binding on the Department as the disciplinary action it shall take. G.O. 43 goes on to provide in the recommended table of Disciplinary Actions following the above quoted provision that for the third offense of insubordination the offender may be dismissed. By letter dated August 10, 1976 (Composite Exhibit 1) Petitioner was advised by Respondent that he was 60 pounds overweight, that his doctor had stated Petitioner's back problem is greatly aggravated and brought about by the overweight problem, and he was directed to make a concerted effort to reduce weight. By letter dated April 7, 1977 (Composite Exhibit 1), Petitioner was suspended from duty for 8 hours without pay for insubordination based upon failure to lose weight as directed in the August 10 letter. By letter dated September 28, 1977 (Composite Exhibit 1) Petitioner was suspended from duty for 16 hours without pay for insubordination for not conforming to weight regulations. By letter dated January 31, 1977 (Composite Exhibit 1) Petitioner was dismissed for the third offense of Insubordination for not conforming to weight regulations. On one or more occasions petitioner was granted sick leave by reason of back problems associated with being overweight.

Florida Laws (3) 120.52120.547.10
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BOARD OF NATUROPATHIC EXAMINERS vs JESSE ALEXANDER, 89-006093 (1989)
Division of Administrative Hearings, Florida Filed:Melbourne, Florida Nov. 06, 1989 Number: 89-006093 Latest Update: Aug. 07, 1990

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 =================================================================

Florida Laws (13) 120.57120.68462.01462.14465.003465.027465.0276766.102893.02893.03893.05893.0790.702
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DEPARTMENT OF TRANSPORTATION vs GENE HYDE TRUCKING COMPANY, 91-005770 (1991)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Sep. 06, 1991 Number: 91-005770 Latest Update: Mar. 09, 1992

The Issue Whether the penalties assessed against Respondent by Petitioner in the amount of $336.00, for allowing its vehicle to be operated with a load which exceeds the permissible gross weight, were proper.

Findings Of Fact Donna Edwards, W.M. Daniels and Robert J. Avery are employees of Petitioner, Florida Department of Transportation, motor carrier compliance section. While so employed on June 22, 1991, Ms. Edwards issued a load report and field receipt to Respondent's driver, Rick Benafield, who was operating a truck owned by Respondent. Ms. Edwards measured and weighed the truck. The weight was 80,480 pounds and the maximum permissible weight for the truck which was 51 plus feet long, is 80,000 pounds. Ms. Edwards assessed Respondent's driver (Benafield) a penalty of $24.00 for being 480 pounds over the maximum allowable weight. On March 31, 1991, Petitioner's employee, W. M. Daniels, measured and weighed a vehicle owned by Respondent. The weight of the vehicle was 80,740 pounds and the bridge weight was 70,740 pounds. The legal maximum allowable weight for the bridge section of the subject vehicle is 69,500 pounds. As a result of being 1,240 pounds overweight in the bridge section, employee Daniels assessed a penalty of $62.00 against Respondent's driver (Benafield). On June 2, 1991, while on official duty, employee Avery issued a load report and field receipt to Respondent's driver, Rick Benafield, and assessed a $250.00 civil penalty for operating a vehicle which was 5,000 pounds over the gross allowable weight of 80,000 pounds on the extension bridge section of the vehicle. The gross weight of the vehicle was 85,000 pounds and the maximum allowable weight was 80,000 pounds. Employees Edwards, Daniels and Avery used standard operating procedures in weighing Respondent's vehicles. Petitioner's scales are tested and certified for accuracy semi-annually in accordance with its rules and regulations.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: Petitioner enter a Final Order denying Respondent's request for a refund of the $336.00 civil penalty assessed its driver, Rick Benafield. DONE and ENTERED this 14th day of January, 1992, in Tallahassee, Florida. JAMES E. BRADWELL 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 14th day of January, 1992. COPIES FURNISHED: Vernon L. Whittier, Jr., Esq. Department of Transportation 605 Suwannee Street, MS 58 Tallahassee, FL 32399-0458 James R. Benafield Gene Hyde Trucking Co. 3315 Swindell Road Lakeland, FL 33809 Ben G. Watts, Secretary ATTN: Eleanor F. Turner Department of Transportation Haydon Burns Building 605 Suwanee Street Tallahassee, FL 32399-0458 Thornton J. Williams, General Counsel Department of Transportation 562 Haydon Burns Building Tallahassee, FL 32399-0458

Florida Laws (2) 120.57316.545
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BOARD OF MEDICAL EXAMINERS vs. ROBERT E. WILLNER, 86-002054 (1986)
Division of Administrative Hearings, Florida Number: 86-002054 Latest Update: Jun. 07, 1989

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.

USC (9) 15 U.S.C 4521 CFR 130.12(a)(5)21 CFR 31221 CFR 330.1021 U.S.C 32121 U.S.C 33421 U.S.C 34321 U.S.C 35221 U.S.C 355 Florida Laws (17) 120.57120.60120.68130.12458.331499.002499.003499.007499.023499.03499.062500.02500.03500.04500.11501.204501.205 Florida Administrative Code (1) 2-1.005
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WHITEHALL BOCA RATON vs AGENCY FOR HEALTH CARE ADMINISTRATION, 01-004331 (2001)
Division of Administrative Hearings, Florida Filed:Fort Lauderdale, Florida Nov. 06, 2001 Number: 01-004331 Latest Update: Feb. 10, 2003

The Issue The issue is whether Respondent failed to maintain the nutritional status of two residents, as required by 42 Code of Federal Regulations Section 482.25(i), so as to justify the imposition of a conditional license rating upon Respondent's skilled nursing facility, pursuant to Section 400.23(7)(b), Florida Statutes, and an administrative fine of $2500, pursuant to Section 400.23(1)(b), Florida Statutes.

Findings Of Fact At all material times, Respondent has owned and operated a skilled nursing facility located at 7300 Del Prado South in Boca Raton. On August 2, 2001, Petitioner completed a survey of the facility. The surveyors cited Respondent for Tag 325, which they classified as a class II (state) or Level G (federal) deficiency. Tag 325 concerns two residents: Resident #9 and Resident #18. The following four paragraphs restate the stipulation into which the parties entered at the hearing. Resident #9 was admitted to the facility on May 22, 2000, with the following diagnoses: stroke, pneumonia, stage III pressure sore at the coccyx, hypothyroidism, urosepsis diabetes, tracheotomy, respiratory dependency on a ventilator, and nutritional dependency on a percutaneous endoscopic gastronomy (PEG) feeding tube. At all times, Resident #9 was wholly dependent on internal feeding for 100 percent of his nutritional needs. At the time of the survey, Resident #9 required Glucerna at one-half strength at the rate of 60 cc hourly plus a supplemental protein powder. At the time of the survey, the coccyx of Resident #9 had a stage III wound, measuring 0.16 inches by 0.08 inches by 0.08 inches. A dietary note states that the amount of feeding for Resident #9 was below his estimated needs. However, the management of Resident #9's feeding was problematic due to his gastrointestinal problems. Resident #18 was admitted to the facility with the following diagnoses: pneumonia, dehydration, fever, atrial fibrillation, and nutritional dependence on PEG tube feeding. A dietary assessment dated July 17, 2001, did not address Resident #18's alleged seven-pound weight loss. Nothing in the clinical records for Resident #18 indicates that the alleged seven-pound weight loss was planned. Resident #18 was admitted to the facility on January 19, 2001 at 78 years of age. At that time, Respondent's staff completed a Nutrition Risk Assessment. The Nutrition Risk Assessment determined that Resident #18's desirable weight range was 128-156 pounds. At admission, Resident #18 weighed 121.5 pounds. According to Respondent's weight log for Resident #18, he weighed the following on the indicated dates in 2001: January 24--121 pounds; January 30--122.2 pounds; February 7--121 pounds; February 14--123 pounds; February 21--119 pounds; February 28--119.4 pounds; March 4--119 pounds; April 4--120 pounds; April 11--122 pounds; May 4--128 pounds; June 6--129 pounds; and July 4--122 pounds. Resident #18's weight decreased by 5.4 percent from June 6, 2001, to July 4, 2001. However, the record does not suggest that this weight loss evidenced any nutritional problems. To the contrary, for 2001, Resident #18's normal weight approximated 122 pounds. As noted in the guidelines to 42 Code of Federal Regulation Section 483.25(i), the desirable weight range stated for Resident #18 is approximate because "ideal body weight charts have not been validated for the institutionalized elderly." Thus, the guidelines warn that "weight loss (or gain) is a guide in determining nutritional status. 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 guidelines offer "[s]uggested parameters for evaluating significance of unplanned and undesired weight loss": five percent over one month is "significant loss" and over five percent over one month is "severe loss." Over a five-month period, Resident #18 gained one pound. Petitioner implicitly places considerable emphasis upon the 128-pound minimum desirable weight range for Resident #18, even though the guidelines suggest caution in establishing ideal weights for the institutionalized elderly. Reliance upon this minimum desirable weight allows Petitioner to ascribe significance to the loss between June 6 and July 4 of the weight gained between April 11 and May 4. However, the record fails to suggest that Resident #18 suffered any nutritional problems for the first two and one-half months of his residency at the facility, when he consistently weighed 119-122 pounds. The record likewise fails to suggest that Resident #18's gain and loss of seven pounds over a three- month period was indicative of any nutritional problems. This short-term change in Resident #18's weight appears either to have been a harmless anomaly or, as Respondent suggests, a measurement error. Evidence supportive of a measurement error is found by comparison of the weight log entry for May 4, which marked the first time Resident #18 weighed as much as 128 pounds, with the Dietary Enteral Assessment for May 2, which showed that Resident #18 weighed only 123.6 pounds two days earlier. Although the latter source documented a weight of 129 pounds on June 6, which corresponds exactly with the data from the weight log, the unlikelihood that Resident #18 gained 4.4 pounds over two days suggests measurement error, such as by using different scales. Resident #9 presents a more complicated case. She was 69 years of age at the time of admission, but suffered from complex medical problems, including serious gastrointestinal difficulties that interfered with her nutrition. At admission, Resident #9, a quadriplegic, was five feet, four inches, tall and weighed 185.4 pounds, according to her Nutrition Risk Assessment, or 191.5 pounds, according to her weight log. According to her Nutrition Risk Assessment, Resident #9's desirable weight range was from 108-132 pounds. Notwithstanding any uncertainty concerning the ideal body weights for the institutionalized elderly, Resident #9 was obese and remained so during the period at issue. Resident #9's Nutrition Risk Assessment deletes the portion of the printed form stating that Resident #9 would suffer "moderate risk" to her nutritional status if she were to lose less than 5 percent of total body weight within one month, less than 7.5 percent of total body weight within 90 days, or less than 10 percent of total body weight within six months. An updated Nutrition Risk Assessment dated June 1, 2000, notes that Resident #9 had gained six pounds, but does not delete the "moderate risk" parameters concerning rates of weight loss. Resident #9 experienced several significant weight losses while a resident at the facility. According to her weight logs, Resident #9 weighed 206-208 pounds from June 7 through August 9, 2000. On August 20, 2000, she weighed 217 pounds, and she gained two more pounds through September 13, 2000. Between September 13 and 27, Resident #9 lost 13 pounds. From September 27 to October 5, Resident #9 regained four pounds to 210 pounds. She weighed within four pounds of 210 through October 25, at which time she weighed 207.4 pounds. Petitioner contends that the first significant weight loss was from 214 pounds on October 18, 2000, to 191.0 pounds on November 14 and 15, 2000, which is a loss of ten percent of body weight within one month. It is also a loss of ten percent of body weight within three months, and the loss of merely one-half pound within six months. Although no one would opine that Resident #9 were healthier at 200+ pounds than at 191 pounds and her weight, over six months, did not change, Respondent must maintain Resident #9's nutrition at all times within the six months in question. However, the improved health at a lower weight and absence of change from admission weight are factors that must inform the determination whether Respondent maintained Resident #9's nutritional status. Petitioner contends that the next two significant weight losses occurred in December 2000 and January 2001. According to the weight log, Resident #9 weighed 184 pounds on December 6, 187 pounds on December 15, 185.4 pounds on December 20, and 186 pounds on December 28. Resident #9 thus lost seven percent of her body weight between November 8 and December 6. Resident #9 continued to lose weight in January 2001. She weighed 181.8 pounds on January 3, 175 pounds on January 10, 178 pounds on January 17, 177.6 pounds on January 24, and 176 pounds on January 30. Between the end of December and end of January, Resident #9 lost 5.4 percent of her body weight. Between December 15 and January 10, she lost 6.4 percent of her body weight. For the three months ending at the end of January, Resident #9 lost 15.1 percent of her body weight, and for the six months ending at the end of January, Resident #9 lost 15.4 percent of her body weight. On February 14, Resident #9 weighed 171.8 pounds, and on March 28 she weighed 172.4 pounds; in between, she weighed more, but never over 179 pounds. On April 4, Resident #9 weighed 167 pounds, but on April 18 and 25, she weighed, respectively, 173 and 174 pounds. Petitioner contends that the next significant weight loss was in April 2000 when she lost 6.2 percent of her body weight between March 7 and April 4. From May 2 through June 13, Resident #9 weighed from 174-178 pounds. On July 3 and July 18, she weighed 167.4 pounds and 165 pounds, respectively, but, on July 11, she weighed only 137.6 pounds. The sudden loss of 30 pounds over eight days followed by the gain of 28 pounds over the next seven days-- given a significant history of much more modest weight changes-- suggests again measurement error. This time, Petitioner seems to concede the point as in its proposed recommended order it contends only that Resident #9 suffered a six percent weight loss in July, which is the weight loss from June 6 to July 3. Despite her obesity, none of Resident #9's weight loss was planned. Among her many gastrointestinal conditions was gastroparesis, which is the impaired ability of the stomach to transport food as part of the normal digestive process, and paralytic ileus, which is the impaired ability of the intestinal tract to transport food as part of the normal digestive process. These serious digestive disorders, as exacerbated by the effect of Resident #9's diabetes on her digestive capabilities, contributed to vomiting, constipation, diarrhea, and, on at least one occasion, the aspiration of feces, which necessitated the suctioning of feces from Resident #9's mouth. At all times, Respondent's staff also had to manage the abdominal distention caused by these digestive disorders so that Resident #9's ventilator-dependent respiration was not compromised; sometimes, maintaining respiratory function required the reduction of nutrition. At other times, Resident #9's veins, already weakened by various diseases, precluded intravenous feeding. In December 2000, Resident #9 suffered a cardiac event; Resident #9's husband, who held a health-care power of attorney for his incapacitated wife, declined the suggestion of outside health care providers that Resident #9 be admitted to a hospital. Respondent's staff tried dozens of interventions, including different nutritional formulas and feeding regimes, to deal with the ever-changing digestive problems that Resident #9 presented. Unable to tolerate bolus feedings, Resident #9 received small frequent feedings, which were easier for her to digest. Unable to tolerate the prescribed caloric intake, staff reduced nutritional levels to the maximum that Resident #9 could tolerate. When Resident #9 became unable to tolerate an intravenous port, staff decided to resort to a PIC line, which penetrates less deeply into the vasculature. However, Resident #9's poor vascular condition and her husband's ongoing preference to avoid more invasive treatment options limited the utility of this option. A registered nurse practitioner working under the supervision of Resident #9's treating physician saw Resident #9 at least as often as every one to two weeks from September 2000 through the August 2001 survey. At times, under the nurse's supervision, the only relief available for Resident #9's intractable gastrointestinal problems was to allow the gut to rest by reducing foods and fluids. The nurse and physician also addressed Resident #9's hypothyroidism, which contributed to a sluggishness. Thus, while managing direct gastrointestinal problems, they were also trying to convert Resident #9 to a new, more active thyroid state--a process that explains some of the weight loss. Overall, Resident #9's weight loss, though unplanned, was not unexpected. Her health care providers properly accepted the weight loss as a secondary, unavoidable issue, as they struggled to reestablish crucial cardiopulmonary, gastrointestinal, and endocrinal functions. Respondent's staff and outside health care providers always monitored all reductions in nutritional levels, as they pursued other, more crucial treatments. Her new weight range ultimately contributed to her health. Petitioner has failed to prove by a preponderance of the evidence that Respondent at anytime failed to maintain acceptable levels of nutritional status for Resident #9 or Resident #18.

Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint in DOAH Case No. 01-4331 and the Administrative Complaint in DOAH Case No. 02-0674. DONE AND ENTERED this 3rd day of July, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 2002. COPIES FURNISHED: William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Virginia A. Daire, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Nelson E. Rodney Assistant General Counsel Agency for Health Care Administration 8355 Northwest 53rd Street, First Floor Miami, Florida 33166 Karen L. Goldsmith Alex Finch Goldsmith, Grout & Lewis, P.A. Post Office Box 2011 Winter Park, Florida 32790

Florida Laws (5) 120.57400.022400.121400.141400.23
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