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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs STEVEN PLISKOW, M.D., 01-004664PL (2001)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Dec. 06, 2001 Number: 01-004664PL Latest Update: Jun. 01, 2002

The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated October 22, 2001, and, if so, the penalty that should be imposed.

Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See Section 455.225, Florida Statutes. The Board of Medicine is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See Section 458.331(2), Florida Statutes. Dr. Pliskow is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 0054211, and he is Board-certified in Obstetrics, Gynecology, and Forensic Medicine. At the times material to this proceeding, Dr. Pliskow practiced obstetrics and gynecology with three other physicians, Dr. Ackerman, Dr. Herbst, and Dr. Aqua, under the name "Advanced Women's Healthcare." In 1996, Dr. Pliskow, Dr. Ackerman, and Dr. Herbst established the Comprehensive Weight Loss & Nutrition Center ("Center") as a separate corporation. Kimberly Payne, an A.R.N.P., was the administrative director of the Center, and, in addition to administrative duties, her job responsibilities included supervision of the nursing staff working in the Center, direct patient care, and staff training. The four physicians practicing at Advanced Women's Healthcare were the designated supervising physicians for staff of the Center. Bariatrics is the subspecialty dealing with the medical treatment of obesity, and the four physicians supervising the Center, as well as Nurse Payne, were members of the American Society of Bariatric Physicians. As members of this organization, the physicians and Nurse Payne received two monthly journals, a biweekly newsletter, a monthly magazine, and faxes and e-mails containing updates on standard-of-care issues, medication changes, updates from the Federal Drug Administration, and suggested treatment changes and recommendations. The organization also provided educational programs and training opportunities for its members. In accordance with the recommendations of the American Society of Bariatric Physicians, the Center's weight loss program included a behavior modification program; a diet providing between 1200 and 1400 kilocalories per day; and an exercise program designed for each of its patients. In addition, if the patient was an appropriate candidate, the Center prescribed anorectic medications, including the combination of the drugs Phentermine and Fenfluramine commonly known as "Phen/Fen." Weight Loss Protocol At the times material to this proceeding, A.R.N.P.s were allowed under Florida law to practice independently under the general supervision of a physician who was accessible to them if they needed a consultation or evaluation of a patient. See Sections 464.003(3)(c) and 464.012(3), Florida Statutes (1995); Rule 64B8-35.002, Florida Administrative Code. Among other things, A.R.N.P.s were allowed to perform physical examinations of patients, to take medical histories, to initiate treatment programs, to prescribe certain types of drugs, and to evaluate patients for signs and symptoms of side effects associated with medications. A.R.N.P.s could not, however, prescribe drugs that were classified as controlled substances. Nurse Payne, and another A.R.N.P. subsequently hired to work at the Center, practiced under the general supervision of Dr. Pliskow, Dr. Ackerman, Dr. Herbst, and Dr. Aqua and in accordance with a protocol setting forth the respective duties of the A.R.N.P.s and of the physicians in the various areas of practice at Advanced Women's Healthcare. The protocol was filed with the appropriate state agency. Section Four of the protocol dealt with weight loss. Pursuant to the general guidelines, the A.R.N.P.s working at the Center were "responsible for the assessment and management of overweight individuals in a comprehensive weight reduction program including nutritional counseling, exercise management, and use of anorectic medications when appropriate." Patient selection criteria were as follows: Any individual who is over their ideal body weight may participate in the nutrition and exercise portions of the program. In order to qualify to participate in the medication portion of the program, the individual must meet the following criteria: Between the ages of 18 and 65 (any person between the ages of 61 and 65 must have medical clearance from their PCP [primary care physician]). Minimum of 20% over ideal body weight. No present history of heart disease, uncontrolled hypertension, cardiac arrhythmia, glaucoma, uncontrolled diabetes, hyperthyroidism, psychotic illness, drug or alcohol abuse, pregnancy, breastfeeding, or impending surgery requiring general anesthesia. Any deviation from these criteria requires collaboration with physician. The following was the General Condition of the weight loss protocol: The A.R.N.P. should consult with the physician on all patients exhibiting abnormal findings which might affect their weight loss management and refer for physician evaluation as needed. Patient C.B. Patient C.B. learned of the Center's weight loss program from her daughter, who had participated in the program and taken weight loss medication. C.B. had an initial consultation at the Center on October 23, 1996. At the time, as recorded on the Center's Weight Reduction Intake Form, C.B. was 62 years of age, her weight was 165 pounds, her height was five feet and four inches, she had a medium frame, her blood pressure was 138/82, and her pulse was 72 beats per minute. The intake form also included her body measurements as of October 23, 1996. As part of the initial consultation, C.B. completed the Center's Weight Reduction Program Questionnaire, in which she stated that she considered her ideal weight to be 135 pounds, that her biggest obstacle to losing weight was staying on a diet, and that she was interested in using medication in her weight loss program. C.B. indicated that she had no limitations on exercise and played tennis regularly. She disclosed her current medications, and she indicated that she did not then, nor had she ever, had the following conditions: heart disease, irregular heartbeat, high blood pressure, glaucoma, diabetes, psychotic illness, or alcohol or drug abuse. Nurse Payne reviewed the Weight Reduction Program Questionnaire with C.B. and completed the intake form. She noted on the intake form that C.B.'s ideal weight was between 120 and 135 pounds, that her weight goal was 135 pounds, and that her body mass index ("BMI") was 28.1 Nurse Payne reviewed with C.B. the information C.B. provided on the questionnaire, including her medical history, current medications, and drug allergies, and Nurse Payne noted on the intake form that C.B. reported arthritis as her only significant medical history. Nurse Payne and C.B. discussed the 1200-calorie exchange diet that was part of the program, and Nurse Payne developed an exercise plan for C.B. that included walking in the pool twice each week and incorporated C.B.'s usual routine of playing tennis three times each week. Nurse Payne noted on the intake form that Dr. Ira Fine was C.B.'s primary care physician. Nurse Payne also discussed medication options with C.B., including the benefits and risks of medications. The intake form included a printed section on medications, in which the first entry was "Pondimin2 20 mg. po bid and Phentermine 37.5 mg. po qd" and the second entry was "Other." Nurse Payne indicated on the intake form that C.B. would be started on "Phen/Fen pending medical clearance [by] Dr. Fine & EKG." Nurse Payne also advised C.B. that she would need to obtain medical clearance from Dr. Fine before medication would be prescribed. During the initial consultation on October 23, 1996, Nurse Payne provided C.B. with a Consent for Diet Program form and discussed with C.B. in detail the information in the consent form. The consent form contained descriptions of both Phentermine and Fenfluramine, together with the contraindications to their use, and Nurse Payne provided C.B. with an excerpt from the Physician's Desk Reference for Phentermine and the packet insert for Pondimin.3 C.B. signed the consent form on October 23, 1996. A blood specimen was drawn from C.B. on October 23, 1996, and Nurse Payne scheduled C.B. for an EKG on October 26, 1996. Nurse Payne telephoned Dr. Fine's office on October 25, 1996, and spoke with "Betty" about medical clearance for C.B. to participate in the weight loss program; she specifically told Dr. Fine's office the program would include the use of Phen/Fen. Nurse Payne was later advised by Dr. Fine's office that Dr. Fine had medically cleared C.B. to participate in the Center's weight loss program.4 Once medical clearance was obtained for a patient and the results of the blood work and EKG were received, the standard procedure at the Center was for the A.R.N.P. to present the patient's chart to one of the supervising physicians.5 The physician would review the test results and the patient's medical history and determine whether it was appropriate to prescribe medications for the patient. If so, the physician wrote the prescriptions, which were then given to the patient. Neither Dr. Pliskow nor Nurse Payne can recall specifically that this procedure was followed in C.B.'s case, but there is nothing in the record to indicate a deviation from this procedure with respect to C.B. C.B. was cleared for participation in the weight loss program and for the use of Phen/Fen based the results of her blood work and her EKG and on the criteria set out in the weight loss protocol: Her primary care physician had given medical clearance; her weight was 20 percent above her ideal body weight; and she had reported no present history of the conditions identified in paragraph II.B.3 of the protocol. Her blood pressure and pulse were normal. The results of her EKG showed no significant abnormality, and there was nothing in the results of the blood work done on October 23, 1996, that would prevent C.B. from participating in the weight loss program or from taking Phen/Fen. C.B.'s initial prescriptions for Phen/Fen were written on October 28, 1996 and, as noted in her chart, were for Pondimin in the dosage of "20 mg. [milligrams] po [orally] bid [twice daily]" and for Phentermine in the dosage of "37.5 mg. [milligrams] po [orally] qd [daily]."6 The medications and dosage prescribed for C.B. remained the same throughout the time she participated in the Center's weight loss program, and no further notations regarding dosage was included in her chart. C.B. initially visited the Center each week; in late November 1996, the frequency of her visits was decreased to once every two weeks, and then, in early February 1997, to once every four weeks. At each visit, a member of the nursing staff at the Center would note C.B.'s blood pressure, pulse, and weight on the progress forms in her chart, together with the amount of weight lost since her last visit. The chart also contained the notes of Nurse Payne or the other A.R.N.P. working at the Center reporting on C.B.'s success in staying on the diet and exercise plans; noting that her medication was "P/F"; and summarizing C.B.'s general progress, anything unusual she reported, and the plan she would follow until the next visit. C.B. also completed at each visit a Follow-Up Questionnaire in which she was asked to report whether, since her last visit, she had experienced chest pain, shortness of breath, dizziness, light-headedness, visual problems, palpitations, abdominal pain, bowel changes, fatigue, difficulty sleeping, depression, irritability, difficulty concentrating, memory loss, tremors, or increased appetite. The Center's standard procedure was for the A.R.N.P. meeting with the patient to discuss the answers in the questionnaire with the patient and to question the patient regarding any problems he or she might be having with the program. Once the A.R.N.P. had examined the patient and completed the patient's progress report, the A.R.N.P. would take the chart to the supervising physician, who would review the chart and write the prescriptions for Phen/Fen. None of the prescriptions for Phen/Fen dispensed at the Center were pre-signed. Patients in the weight loss program received new prescriptions for Phen/Fen at each visit to the Center. Because Phentermine and Fenfluramine are controlled substances, there could be no refills on a prescription, so the prescriptions were written for a sufficient number of pills to last until the patient's next visit to the Center. Although the prescriptions were written and signed by one of the supervising physicians, the physicians did not sign the patient's chart. After the supervising physician wrote the prescriptions, the A.R.N.P. would take the prescriptions to the patient, who could have them filled at the pharmacy in the offices of Advanced Women's Healthcare or at a pharmacy elsewhere. There is nothing in the record to indicate that this practice was not followed with respect to the prescriptions issued to C.B.7 On November 4, 1996, her first visit after beginning the program, C.B. reported one episode of light-headedness. Otherwise, C.B. reported none of the symptoms identified in the questionnaire and reported no problems with the program. Had C.B. reported experiencing anything abnormal, Nurse Payne would have called in one of the physicians supervising the Center for a consultation. C.B. participated in the Center's weight loss program through April 7, 1997, which was the date of her last visit. C.B. lost weight on the Center's program at a slow but steady rate, usually between one and four pounds between visits, until, on April 7, 1997, she weighed 141 pounds. C.B.'s treatment with Phen/Fen ended before May 1997, when the Florida Board of Medicine published stricter limitations on the use of these medications.8 Although Dr. Pliskow was not present in the office on October 28, 1996, when C.B.'s first prescriptions for Phen/Fen were written, he was present in the office during four of C.B.'s ten visits to the Center. Because at least one other physician was also present in the office during these four visits, Dr. Pliskow may or may not have reviewed C.B.'s chart and written her prescriptions.9 Summary The evidence presented by the Department is not sufficient to support a finding that Dr. Pliskow practiced medicine below the level of care considered acceptable by a reasonably prudent physician under similar circumstances or to support a finding that Dr. Pliskow failed to document in C.B.'s medical records justification for the course of her treatment in the weight loss program and the dosage of the medications prescribed for her. The evidence is not sufficient to establish clearly and convincingly that the prevailing standard of care required the physician supervising the Center's A.R.N.P.s personally to perform a physical examination of C.B. prior to her being cleared for receiving medication as part of her weight loss program or personally to obtain C.B.'s medical history. Rather, it was appropriate for Nurse Payne and the other A.R.N.P. working at the Center to perform physical examinations and to take medical histories of persons seeking to participate in the Center's weight loss program. In addition, the evidence is not sufficient to establish clearly and convincingly that it was inconsistent with the prevailing standard of care for the Center's supervising physicians to rely on C.B.'s primary care physician to provide medical clearance for her to participate in the weight loss program. Dr. Fine was familiar with C.B.'s overall medical condition as a result of his examination of her on September 12, 1996, and he was, therefore, competent to assess the overall risks of her participation in a weight loss program incorporating the use of anorectic medications. Furthermore, the evidence fails to establish that it was inconsistent with the prevailing standard of care to rely on the verbal medical clearance conveyed to Nurse Payne through Dr. Fine's office; rather, the persuasive evidence suggests that it was the normal practice for clearance to be given in this manner.10 And, significantly, Dr. Fine's medical clearance was not the only basis for C.B.'s clearance to take anorectic medications: C.B.'s vital signs were recorded on the intake form by the Center's nursing staff, and Nurse Payne compiled C.B.'s medical history from C.B.'s answers to questions on the Weight Loss Program Questionnaire and from discussions with C.B; an EKG and extensive blood work were ordered for C.B., and a physician reviewed C.B.'s chart and the results of these tests before writing C.B. prescriptions for anorectic medications.11 The evidence is not sufficient to establish that the physicians practicing at Advanced Women's Healthcare failed to provide the appropriate level of supervision to the A.R.N.P.s who worked in the Center. A.R.N.P.s are independent practitioners, and they are subject only to the general supervision of a physician. The evidence failed to establish that the prevailing standard of care for physicians supervising A.R.N.P.s required anything more than that the physician be available for consultation. At least one physician was available in the Advanced Women's Healthcare offices at all times for consultation and/or patient evaluation if an A.R.N.P. working at the Center determined that a patient was experiencing any complications or if a patient reported any unusual symptoms. The evidence is not sufficient to establish clearly and convincingly that the type and scope of information collected during C.B.'s regular visits to the Center and the on-going care provided to C.B. were not appropriate under the prevailing standard of care for monitoring patients on weight loss programs such as C.B.'s. The prescriptions for C.B.'s weight loss medications were written by a physician at each of C.B.'s visits, but only after the physician reviewed her chart, which included the A.R.N.P.'s progress notes and C.B.'s answers on the Follow-Up Questionnaires she completed at each visit, to determine whether it was appropriate to continue C.B. on anorectic medications.12 The evidence also fails to establish that the prevailing standard of care required a supervising physician to sign a chart prepared by an A.R.N.P. to indicate that it had been reviewed.13 The evidence is not sufficient to establish that C.B. was not an appropriate candidate for a weight loss program using Phen/Fen under the prevailing standard of care in 1996 and early 1997.14 Adequate justification for the treatment of C.B. with anorectic medications was included in C.B.'s medical records: She was considered obese by 1996 standards because her weight of 165 pounds was more than 20 percent higher than her ideal body weight of 120-to-135 pounds and because her BMI was 28 and she wanted to lose weight. In addition, nothing in the medical history C.B. provided to Nurse Payne or in her tests results indicated that she would be an inappropriate candidate for anorectic medications, and she reported no complications during her follow-up visits.15 The evidence is not sufficient to establish clearly and convincingly that the dosages of Phen/Fen prescribed for C.B. were inappropriate or excessive under the prevailing standard of care in 1996 and early 1997. Rather, the dosages prescribed for C.B. were in the lower range of dosages recommended at the time by the American Society of Bariatric Physicians and in the medical literature in general for the use of Phentermine and Fenfluramine in combination.16 The dosage of both medications was printed on the intake form completed during C.B.'s initial visit to the Center, and the dosages did not change during the time C.B. participated in the Center's weight loss program; in accordance with normal practice, no further notations were made regarding dosages in C.B.'s chart. New prescriptions were written each time C.B. visited the Center, and no refills were permitted, which is also in accordance with the standard practice in dispensing controlled substances.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing in its entirety the Administrative Complaint against Steven Pliskow, M.D. DONE AND ENTERED this 30th day of April, 2002, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of April, 2002.

Florida Laws (7) 120.569120.57455.225456.073458.331464.003464.012
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DEPARTMENT OF TRANSPORTATION vs M AND M TRUCK SERVICE, INC., 93-000066 (1993)
Division of Administrative Hearings, Florida Filed:Orlando, Florida Jan. 06, 1993 Number: 93-000066 Latest Update: Jun. 08, 1993

The Issue Whether a commercial motor vehicle owned by Respondent exceeded the posted weight when it crossed a "low limit" bridge in rural Brevard County, Florida on June 3, 1992, in violation of Section 316.545, Florida Statutes. Whether extenuating circumstances justifies the reduction or elimination of the proposed penalty for the alleged violation.

Findings Of Fact The Florida Department of Transportation (DOT) is the state agency charged with the duty to administer and enforce the provisions of Chapter 316, Florida Statutes, which regulates the weight and load of commercial motor vehicles on the state highway system. State Road 520, in Brevard County, Florida, is a part of the state highway system, and title to the right-of-way for said highway is held in the name of the State. A bridge which crosses over the St. Johns River on State Road 520 (SR520) in Brevard County, Florida, had a weight limit of 80,000 pounds for motor vehicles until October 20, 1991. On that date, the maximum weight for vehicles was reduced to a limit of 56,000 pounds. On May 26, 1992, the weight limit was again reduced, and the Department posted a new weight limit for the bridge of 30,000 pounds. On June 3, 1992, a commercial motor vehicle owned by Respondent was traveling northbound on Interstate 95 (I-95). The vehicle exited I-95, proceeded westbound on SR 520, and crossed the bridge. After the vehicle crossed the bridge, it was stopped by a Department Transportation Officer, and taken to a nearby pit scale. The weight of the vehicle was accurately determined to be 56,140 ponds. The Transportation Officer then imposed a fine of $1,307.00 on the vehicle, based on 5 cents per pound above the posted weight limit of 30,000 pounds. The penalty was paid by M & M Truck Service, and the vehicle was permitted to proceed. M & M Truck Service sought a refund of the penalty from the Commercial Motor Carrier Review Board. The Board authorized a 50 percent refund under its policy providing for a 50 percent refund when vehicles exceed a posted weight limit within 30 days of the date of a posted weight reduction. The following standard weight limit signs, each showing a 30,000 pound weight limit, had been posted by the Department on SR 520, from I-95 to SR 528, on May 26, 1992: Facing Eastbound on SR 520 (in Brevard County): Just east of I-95: "Weight Limit Last Exit" Just west of I-95: "Weight Limit" (no distance to bridge stated) 2 miles east of the bridge and just east of SR 524: "Weight Limit 2 Miles" Just east of the bride: "Weight Limit" Facing Westbound on SR 520 (in Orange County): Just west of SR 528: "Weight Limit 9 Miles" 4.2 miles west of bridge: "Weight Limit Restriction Ahead" (no distance to bridge state) 4 miles west of bridge: "Weight Limit 4 Miles" Just west of SR 532: "Weight Limit Last Exit" 2 miles west of the bridge: "Weight Limit 2 Miles" Just west of the bridge on the St. Johns River: "Weight Limit" The above signs meet current MUTCD standards. MUTCD refers to the Federal Highway Administration Manual on Uniform Traffic Control Devices, 1988 Edition, which has been incorporated by reference into Florida Administrative Code Rule 14-15.010. SR 520 was under construction at the time the vehicle crossed the bridge, and the driver did not observe the signs posted by the Department.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a Final Order be entered finding that a penalty correctly assessed to M & M Truck Service, Inc., under the provisions of Section 316.545, Florida Statutes, and that no refund of the reduced penalty of $653.00 should be made. DONE and ENTERED this 8th day of June, 1993, 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 8th day of June, 1993. APPENDIX Petitioner's proposed findings of fact: Accepted in substance by stipulation. Respondent's proposed findings of fact: Consisted of argument directed to the stipulated facts and need not be specifically ruled upon. COPIES FURNISHED: Paul Sexton, Esquire Assistant General Counsel Department of Transportation 605 Suwannee Street Tallahassee, Florida 32399-0450 Gary E. Moses, President M & M Truck Service, Inc. 313 Shadow Oak Drive Casselberry, Florida 32707 Ben G. Watts, Secretary Attn: Michelle Arsenault #58 Department of Transportation Haydon Burns Building 605 Suwannee Street Tallahassee, Florida 32399-0458 Thornton J. Williams General Counsel Department of Transportation 562 Haydon Burns Building 605 Suwannee Street Tallahassee, Florida 32399-0458

Florida Laws (3) 120.57316.545316.555 Florida Administrative Code (1) 14-15.010
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SHADY REST CARE PAVILION, INC., D/B/A SHADY REST CARE PAVILION vs AGENCY FOR HEALTH CARE ADMINISTRATION, 02-001965 (2002)
Division of Administrative Hearings, Florida Filed:Fort Myers, Florida May 14, 2002 Number: 02-001965 Latest Update: Mar. 19, 2003

The Issue Whether Shady Rest Care Pavilion, Inc. failed to maintain the nutritional status of one of its residents so as to justify the imposition of a conditional license rating upon the facility and an administrative fine of $2,500.

Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings are made: Shady Rest is licensed by the Agency as a skilled nursing facility. Shady Rest's license number is SNF1497096. The Agency conducted an on-site survey of Shady Rest from July 30, 2001, to August 2, 2001. At the time of the survey, Shady Rest's licensure status was standard. The survey was conducted by a "team" that included dietitian Lori Riddle and other health care professionals. The survey team identified several deficiencies at the facility. The deficiencies were detailed on the Form 2567 which was provided to Shady Rest by the Agency. The only deficiency still at issue in this proceeding is the Tag F325 which was summarized on the Form 2567 as follows: Based on observations, clinical record review and staff interviews, the facility failed to ensure that nutritional needs were met for 3 (Residents 11, 21 and 22) of 5 active sampled residents receiving tube feeding who were at high risk for malnutrition as evidenced by significant weight loss, low albumin and total protein levels and recurring pressure sores. The survey team classified the Tag F325 at Level "G" (i.e., isolated actual harm) on the federal scope and severity matrix, which corresponds to an isolated Class II deficiency under the Florida classification scheme. Based upon the cited Class II deficiency, the Agency issued a notice of intent to change Shady Rest's licensure status from standard to conditional, and the Agency initiated a separate action to impose an administrative fine upon Shady Rest. This proceeding followed. At the hearing, the Agency narrowed the focus of the alleged deficiency from the three residents identified on the Form 2567 to only one, Resident 11. No evidence or testimony was presented regarding any other residents. Resident 11 is a female. At the time of the survey, she was 89 years old, 64 inches (five feet, four inches) tall, and weighed 145 pounds. She has been at Shady Rest since 1987. A care plan for Resident 11 was developed by a "team" that included the director of nursing at Shady Rest, a nurse (Sonja Reece, R.N.), a dietitian (Ann Marie Shields, R.D.), two care plan coordinators, and social service and activity personnel. Members of the care plan team worked closely with Resident 11's physician, Dr. Lakshmi Bushan, to manage Resident 11's medical conditions. Dr. Bushan was actively involved with the care of Resident 11 and was very familiar with her conditions. Dr. Bushan was at the facility on a weekly basis and sometimes several times per week. Resident 11 is totally dependent on Shady Rest and its staff for the provision of nutrition. She is fed through a tube connected directly to her stomach. Resident 11 is a "very complex resident" as a result of a myriad of serious medical conditions, including heart attack, seizure disorder, edema (i.e., swelling of the tissues due to fluid retention), hiatal hernia with reflux, pemphagus (i.e., an autoimmune disease resulting in blisters around the body), congestion in the lungs which caused breathing problems, kidney disease, and liver problems. She was also prone to skin breakdown. The treatment of Resident 11 was complicated by the fact that management of one of her conditions would exacerbate another. For example, the Prednisone she was taking to treat her pemphagus increased her fluid retention and, hence, her edema; but, Lasix, the diuretic she was taking for the edema, caused her to have diarrhea which led to the breakdown of her skin from constant cleaning and put her at risk of dehydration and kidney failure. Resident 11's edema was at a dangerous level, referred to as "3+ pitting edema." Relieving the edema was determined to be of critical importance to Resident 11 by her physician. The fluid retention in Resident 11's lungs caused her to suffer from shortness of breath which could ultimately lead to congestive heart failure. Because Resident 11 did not respond well to Lasix and because it actually exacerbated her other medical problems (i.e., skin breakdown), a fluid reduction diet was deemed necessary by her physician. Resident 11 was overweight, partially due to her edema. Resident 11's weight contributed to and exacerbated her medical conditions, particularly her congestion and breathing problems, and it enhanced her risk of congestive heart failure. On April 3, 2001, Dr. Bushan ordered an evaluation of Resident 11's nutritional status and the adequacy of her tube feeding. Resident 11 weighed 163 pounds on that date. On April 4, 2001, Ms. Shields, performed the evaluation ordered by Dr. Bushan. Ms. Shields calculated the total calories per day (cal/day) needed by Resident 11 based upon a standard formula. She then subtracted 400 cal/day to take into account the weight loss desired by Dr. Bushan. Ms. Shields' calculation resulted in an estimated caloric need for Resident 11 of 1,100 to 1,200 cal/day. Because the feeding ordered at that time provided 1,125 cal/day, which was within the range computed by Ms. Shields, no changes were made to Resident 11's diet at that time. Resident 11 was, however, taken off Lasix at that time because it was not contributing significantly to her weight loss and it was putting her at risk for dehydration and kidney failure. Resident 11's weight dropped only slightly after the April 4, 2001, evaluation. On May 1, 2001, she weighed 159 pounds and on June 1, 2001, she weighed 158 pounds. Dr. Bushan wanted Resident 11 to lose more weight more rapidly to stabilize her serious medical conditions. Accordingly, on June 13, 2001, Dr. Bushan requested a dietary consultant to check the amount of Resident 11's tube feedings in order to implement a planned weight loss program to reduce Resident 11's weight to 145 to 150 pounds. Ms. Shields conducted the assessment on June 14, 2001, and after consulting with Resident 11's care plan team, she recommended to Dr. Bushan that Resident 11's caloric intake be reduced from 1,125 cal/day to 750 cal/day to accomplish the rapid and significant weight loss desired by Dr. Bushan. Dr. Bushan accepted Ms. Shield's recommendations and ordered the reduction in calories on June 14, 2001. On that date, Resident 11 weighed 158 pounds. Resident 11's care plan was updated on June 14, 2001, to reflect the goal of reducing her weight by not more than five pounds per week until she reached less than or equal to 150 pounds. The dietary change achieved the desired effect of rapidly reducing Resident 11's weight and stabilizing her medical conditions. Her weight records showed the following: Date June 20, 2001 Weight 153 June 27, 2001 153 July 4, 2001 152 July 11, 2001 153 July 18, 2001 152 July 25, 2001 n/a August 2, 2001 145 The dietary notes for August 1, 2001, indicate that Resident 11's "weight goal was met" and recommended a dietary change to increase Resident 11's caloric intake to 1,000 cal/day. The record does not include the doctor's order implementing that recommendation. However, by August 8, 2001, Resident 11's weight was at 151 pounds, suggesting that the dietary change was implemented. Between the June 14, 2001, dietary change and the August 2, 2001, survey, Resident 11 lost 13 pounds, which is an 8.2 percent weight loss. For the three-month period of May 1, 2001 through August 2, 2001, Resident 11 lost 14 pounds, which is an 8.8 percent weight loss. Resident 11's edema improved significantly during this period; it was no longer at the "3+ pitting edema" level. In this regard, some of Resident 11's weight loss is attributable to the elimination of retained fluids (i.e., reduction in her edema), which was a significant purpose of the weight loss program. The amount of the weight loss attributable to the fluid loss is not quantifiable. The federal guidelines discussing Tag F325, which the Agency's survey team uses in its evaluation of a facility, state that "weight loss (or gain) is a guide in determining nutritional status" and identify parameters to be used in evaluating the significance or severity of weight loss. The 8.8 percent weight loss experienced by Resident 11 over a three- month period would be considered "severe" based upon the parameters. The parameters in the federal guidelines specifically refer to "unplanned and undesired weight loss." By contrast, the weight loss experienced by Resident 11 was planned and desirable. It was directed by Dr. Bushan after Ms. Shield's dietary consultation in order to reduce Resident 11's fluid intake and her edema while also promoting rapid weight loss to minimize her congestion and related breathing problems. The estimated protein needs for Resident 11 were 53 to 57 grams per day. The protein that she was being given, both prior to and after the June 14, 2001, dietary change was within that range. Increasing Resident 11's protein to offset the calorie reduction was not considered a viable option for Resident 11 because her history showed that the more protein she received the more weight she gained. Moreover, too much protein could cause liver failure, which was a risk for Resident 11. When the body is not receiving enough calories, it can metabolize protein as a calorie source rather than for the purposes protein is normally used, such as health of the skin. Resident 11 experienced skin breakdown (i.e., pressure sores or decubitus ulcers) after the June 14, 2001, dietary change. The sores were very small in size and, consistent with Resident 11's past history, the sores healed quickly. Therefore, they are not indicative of a protein deficiency. Indeed, subsequent to the dietary change, Resident 11's skin turgor was good. The laboratory reports for Resident 11 showed her having low albumin levels after the dietary change. Low albumin is generally an indicator of insufficient protein in the body. However, as noted above, the rate at which Resident 11's skin healed suggests that she was getting sufficient protein. Resident 11's low albumin level, in and of itself, is not determinative of her nutritional status. Indeed, the federal guidelines provided to the survey team state: Because some healthy elderly people have abnormal laboratory values, and because abnormal values can be expected in some disease processes, do not expect laboratory values to be within normal ranges for all residents. Consider abnormal values in conjunction with the resident's clinical condition and baseline abnormal values. Even before the June 14, 2001, dietary change, Resident 11's albumin level was not within the normal range. Her abnormal albumin levels may have been the result of her liver problems. Dr. Bushan and the care plan team at Shady Rest managed Resident 11's care based upon their clinical observations of her in conjunction with their experience regarding what worked for her in the past, not simply based upon her laboratory values. They were constantly weighing standards of practice with what was actually happening with Resident 11.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration issue a final order which: Dismisses the Administrative Complaint against Shady Rest Care Pavilion in DOAH Case No. 02-1291; and Rescinds the notice of intent to assign conditional licensure status to Shady Rest Care Pavilion in DOAH Case No. 02-1965 and retains the facility's standard licensure status. DONE AND ENTERED this 26th day of August, 2002, in Tallahassee, Leon County, Florida. T. KENT WETHERELL, II 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 26th day of August, 2002.

Florida Laws (5) 120.569120.57400.023400.121400.23
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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 HEALTH AND REHABILITATIVE SERVICES vs. MANDARIN MANOR NURSING AND RETIREMENT CENTER, 83-003413 (1983)
Division of Administrative Hearings, Florida Number: 83-003413 Latest Update: Jul. 30, 1984

The Issue Petitioner cited Respondent with deficiencies related to its nursing home operation, as a result of an annual survey. The deficiencies were classified as Class II deficiencies. Respondent has challenged the classification of the deficiencies, in view of the effect of such classification on the rating assigned to the Respondent. The hearing was conducted to consider that challenge.

Findings Of Fact Mandarin Manor nursing home is a facility in Jacksonville, Florida, which is licensed by the State of Florida, Department of Health and Rehabilitative Services, to provide nursing home services. An annual inspection of the nursing home facility was conducted by Petitioner beginning June 13, 1983, and concluding on June 15, 1983. During the course of the inspection, on June 13, 1983, it was discovered that patient W in the B Wing of the facility who was supposed to have received ice cream on the evening of June 12, 1983, had not received that snack, notwithstanding the fact that it had been charted in the medical record as having been received. The ice cream had been found in a refrigerator on the wing and was identified as being for the benefit of that patient. (This snack and all subsequent snacks or meals that are reported in this Recommended Order had been ordered by physicians who were treating the patients in the facility.) On June 13, 1983, patient R.T. in the A Wing was found to have missed the provision of Travasorb at 10:00 a.m., June 10, 1983. Travasorb is a canned supplemental feeding given to increase calories and protein within the diet, or in some instances forms the diet plan for patients who cannot eat solid food. It was noted in the patient's chart that all required feedings had been given the patient on June 10, 1983. Further inspections were made on June 14, 1983, to determine whether required feedings and meal supplements were being given patients in the facility. On the B Wing it was indicated that for patient M at hour of sleep on June 13, 1983, the patient had received Travasorb. Notwithstanding the charting in the patient's record, the patient had not received that substance. Again, this was determined by finding the substance in the storage area on the wing. (On all other subsequent occasions reported related to the failure to provide the supplement or feeding, verification was made by finding the substance in the storage area on the wing where the patient was housed.) Patient C-1, a diabetic patient, was charted in the medical chart as receiving milk on June 13, 1983, at hour of sleep, when in fact the patient had not received milk. The patient had received juice instead, an inappropriate substitute for milk. As observed on June 14, 1983, patient S was supposed to have received Travasorb at 8:00 p.m. on June 13, 1983, but did not receive that substance. It was not charted as refused. Patient D was supposed to receive four ounces of cranberry juice on June 13, 1983, at time of sleep but did not receive that sub- stance. Nonetheless, the substance was charted in the medical records as given. Patient C-2, another diabetic patient, was supposed to receive several substances as part of the diet for the patient. These substances were to be received at hour of sleep on June 13, 1983, and included diabetic fruit, low-cal cranberry juice, and skim milk. Although these substances were charted as being given to the patient, they were not received by the patient. Patient W, the same W as the evening before, was indicated as having received a Travasorb milkshake at hour of sleep on June 13, 1983, when in fact he (she) did not receive that substance, notwithstanding the entry in the medical records. On June 14, 1983, the A Wing supplemental food situation was reviewed and it was found that patients J-1 and J-2 supposedly had been given WN-34 at 2:00 p.m. and at hour of sleep, respectively, when in fact the patients had not received the substance. One of the J's was a diabetic. WN-34 is nourishment which is a chemicalized formula preparation. Patient C-3 was charted as having received ice cream on June 13, 1983, at 2:00 p.m., when in fact he (she) had not received that substance. A number of other patients in the A Wing on June 14, 1983, refused their supplemental food or diet, as reflected in the notes of the inspector, a copy of which is found as Petitioner's Exhibit 3, admitted into evidence. This same exhibit notes the other findings that are set forth in discussing the patients who have been identified by initials. 1/ No particular review by Petitioner was made of the patient records to determine medically the exact condition of the patients and the effects of not providing the diet or supplemental snacks. The dietary consultant to Mandarin Manor, Faith Robinson Welch, who is a registered dietitian, in her monthly inspection of the facility, observed problems with the provision of diet items or supplemental snacks ordered by the physicians and the charting of those items in the medical records of the patient as early as December, 1982, and continuing through June 1983. It was recommended that procedures be followed for indicating if the food had been accepted or refused, with special reference to diabetic patients. The administrator had been provided copies of the reports and had discussed these problems with the dietary consultant. Therefore, at the point of the June, 1983, inspection by the Petitioner the facility was on notice of the problems observed in the course of the inspection. As shown in Petitioner's Exhibit 6, which was admitted into evidence, which is a copy of the dietary consultant's reports, the problems in the past were much the same as were observed in the June, 1983, inspection by the Petitioner. These problems, as noted by the dietitian, had led the nutritionist inspector, Sharron Lucks, employee of the Petitioner, to inspect the A and B Wings within the facility on June 13 and 14, 1983. The reports by Welch do not refer by name to patients who would be the same as checked by Petitioner in its June, 1983, inspection. As established, all of the food had been ordered by physicians for the patients in those instances of problems identified in the June 13 and 14, 1983, inspections. As such, it was important to comply with the physicians' instructions. It was particularly so related to the diabetic patients, in that their frequent feeding is a part of a diet plan and not in the category of a supplemental snack. None of the diabetics who were overlooked are "brittle" diabetics, such that the missing of a meal would cause radical swings in blood sugar levels. Nonetheless, some of the diabetics who were involved were receiving insulin and a proper caloric count is important. Dr. Jack Edward Giddings, a medical doctor, who is on the staff at the Mandarin Manor facility and has served as medical director of that facility, testified that the oversight on occasion of provision of diet to the diabetics or supplemental snacks to other patients, would not be detrimental. Over an extended period of time he feels that the patient would suffer. His observations establish that diabetics are receiving the subject food as part of their diet and are in a more critical category, although he saw no harm on this occasion. Dr. Giddings had reviewed some of the charts of the patients subsequent to the events that are in question related to the inspection of June 13 and 14, 1983, and found no indication of health problems subsequent to the inspection, which were attributable to missing parts of the diet or snacks. It is not clear whether he examined charts of all the patients which are at issue on the topic of missing the feedings. Dr. Giddings and other treating physicians also indicated in a pro forma letter or note that certain patients were not affected by the oversights set forth in this account. Those documents may be found as part of Petitioner's Exhibit 5, admitted into evidence. These letters or memoranda do not speak to the patients C-1, S, and C-3. Patient M-2 had been prescribed a special diet of 60 grams of protein, 2 grams sodium. Lucks, in inspecting the food preparation and delivery on June 13, 1983, noticed that when the tray for M-2 had been prepared only one pat of oleo was provided instead of the three called for, and that four ounces of milk that was not called for was placed on the tray. Cornbread was provided instead of bread, but was similar in amount and is an acceptable substitution. Once these matters had been noted by Lucks and also by the dietary consultant Welch, the tray was taken off the service line and corrections made to the diet plan before the patient received the meal. The tray of patient M-2 was also observed by Lucks at breakfast on June 14, 1983. The tray was passed by the hot food servers and beyond that point the tray was held up by Lucks in view of the fact that bacon had been placed on the tray and the bacon was not called for. The patient has problems with renal failure and bacon is a substance high in sodium and is not normally called for in a special diet such as patient M-2 was receiving, in that a patient with this condition has trouble eliminating extra sodium from his (her) system. Lucks having discovered the problem, the patient received the appropriate meal. In Dr. Giddings' opinion, had patient M-2 received the milk, there was not sufficient salt in it to alter the patient's health. Neither would Dr. Giddings find a problem with the receipt on this one occasion of the bacon that was mistakenly placed on the tray on June 14, 1983, for the breakfast meal. This patient was subsequently discharged and returned home. Following the inspection, the problems as observed on June 13 and June 14, 1983, related to provision of diet and supplemental snacks were found to be a NH-110 violation, Class II. The problems with the preparation of the meal tray for patient M-2 were cited as a NH-111 violation, Class II. This coding pertains to Rule 10D-29.110(3)(d)3. and (3)(e)1., Florida Administrative Code, respectively. The effects of such declaration of violation would cause the, Respondent to lose superior rating as a nursing home. Consequently, it challenged the classification of the two violations leading to the Subsection 120.57(1), Florida Statutes, hearing. Should the violations be found to be Class III and not Class II violations, the parties have stipulated that all other prerequisites to recognition of the nursing home as a superior facility have been achieved, specifically related to the dietary area. See Rule 10D- 29.128, Florida Administrative Code.

Florida Laws (2) 120.57400.23
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AGENCY FOR HEALTH CARE ADMINISTRATION vs HEALTHPARK CARE CENTER, INC., D/B/A HEALTHPARK CARE CENTER, 02-001788 (2002)
Division of Administrative Hearings, Florida Filed:Fort Myers, Florida May 08, 2002 Number: 02-001788 Latest Update: Mar. 26, 2003

The Issue DOAH Case No. 02-0033: Whether Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 02-1788: Whether Respondent committed the violations alleged in the Administrative Complaint dated March 13, 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. Healthpark operates a licensed nursing home at 16131 Roserush Court, Fort Myers, 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 15 through 18, 2001, AHCA conducted an annual licensure and certification survey of Healthpark, to evaluate the facility's compliance with state and federal regulations governing the operation of nursing homes. The survey team alleged three deficiencies during the survey, two of which are at issue in these proceedings. At issue are deficiencies identified as Tag F224 (violation of 42 C.F.R. Section 483.13(c)(1)(i), relating to neglect of residents) and Tag F325 (violation of 42 C.F.R. Section 483.25(i)(l), relating to maintenance of acceptable parameters of nutritional status). Both of the deficiencies alleged in the survey were 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. Both of the deficiencies alleged in the survey were cited at a federal scope and severity rating of G, meaning that each deficiency was isolated, caused actual harm that is not immediate jeopardy, and did not involve substandard quality of care. Based on the alleged Class II deficiencies in Tags F224 and F325, AHCA imposed a conditional license on Healthpark, effective October 18, 2001. The license expiration date was September 30, 2002. Tag F224 The survey allegedly found violations of 42 C.F.R. Section 483.13(c)(1)(i), which states: Staff treatment of residents. The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property. The facility must-- (i) Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion.... In the parlance of the federal Health Care Financing Administration Form 2567 employed by AHCA to report its findings, this requirement is referenced as "Tag F224." The Agency's allegations in this case involved neglect of a resident rather than any form of abusive treatment. The Form 2567 listed two incidents under Tag F224, both involving Resident 10, or "R-10." The surveyor observations read as follows: Based on observations, record review and interviews with a resident and a Certified Nursing Assistant (CNA), the facility failed to provide toileting needs as care planned for 1 (Resident #10) of 8 sampled residents reviewed for incontinence and toileting programs. The resident was not toileted for more than 5 hours causing multiple creased areas and redness to her left groin, perineum and buttocks. The findings include: On 10/15/2001, Resident #10 was in her room, #141, in bed A at 2:20 P.M. Resident stated she was wet. The call bell cord was clipped to the sheet, but the bell mechanism was off the side of the bed, out of the resident's reach. Surveyor walked to the North nurse's station and continued to observe the resident's room entrance. Record review revealed Resident #10's most recent quarterly Minimum Data Set (MDS) completed 8/27/2001, assessed her with bladder incontinence at 3 (frequently incontinent), bowel incontinence at 1 (less than once weekly), activity is assessed as bed mobility 3/3 (needs extensive assistance to move in bed), and toilet use at 3/2 (needs extensive assistance). At 4:15 P.M., the resident requested the surveyor to get someone to change her as no one had come in and the call bell was still out of her reach. The resident's request was given to the nurse at 4:20 P.M. On 10/16/01, Resident #10 was observed in her wheelchair in the hall outside her room from 8:55 A.M. until 12:05 P.M., when she was escorted to the main dining room. At 2:20 P.M., resident was still sitting in her wheelchair. After surveyor intervention, the CNA put the resident to bed at 2:30 P.M. When the adult diaper was removed, it revealed the resident to be incontinent of feces and urine. The odor of urine was very strong in the room. The resident's perineum and buttocks were red and moist, with multiple creased areas. The left groin was especially red. During an interview with the CNA, she stated the resident was last toileted before lunch at approximately 11:00 A.M. This was during the time of direct observation by the surveyor of the resident in the hall outside her room. Review of the resident's Care Plan revealed that she was to have the call bell in place at all times and scheduled toileting. Diane Ashworth was the survey team member who recorded the observation of R-10. Ms. Ashworth was assigned the task of observing R-10, and based her findings on a review of the resident's medical records, observations and interviews. R-10 was a 96-year-old diabetic female who had been admitted to Healthpark on March 28, 2000. R-10's most recent Minimum Data Set ("MDS"), completed on August 27, 2001, indicated that R-10 had short and long-term memory difficulties and moderately impaired decision making as to tasks of daily life. R-10 was generally confused as to place and time. She could make herself understood, and had no difficulty understanding what was said to her. She was easily angered and could be physically abusive to staff. R-10 required extensive assistance to move, dress, toilet, and maintain general hygiene. She was confined to her bed or to a wheelchair, and required assistance to move the wheelchair. R-10's MDS indicated a loss of voluntary movement in her hands, including her wrists and fingers. The MDS indicated that R-10 experienced daily incontinence of the bladder, and bowel incontinence once a week on average. The nurse's notes for R-10 indicated that she was able to make her needs known and that she was encouraged by staff to call for assistance as needed. The care plan for R-10 stated that she should have "scheduled toileting," but set forth no firm schedule. Ms. Ashworth testified that she would have expected R-10 to be toileted before meals, before bed, and upon rising, at a minimum. Mona Joseph was the CNA who attended R-10 on a daily basis. Ms. Joseph testified that R-10, like all residents who wore adult diapers, was scheduled for toileting every two hours and whenever necessary. In practice this meant that Ms. Joseph would inquire as to R-10's need for toileting every two hours. Ms. Joseph testified that R-10 would ask her for toileting at least twice a day, and that she never refused the request. She always toileted R-10 before lunch, and testified that on October 16 she toileted R-10 at about 11 a.m. before taking her to lunch. Toileting R-10 required the use of a Hoyer lift to move the resident from her wheelchair to the bed. Ms. Joseph estimated that the entire process of toileting R-10 took seven to eight minutes. Caroline Nicotra, the supervisor of the long-term care unit in which R-10 resided and Ms. Joseph's supervisor, confirmed that Healthpark's CNAs were trained to make rounds every two hours and ask those residents requiring assistance if they needed to be toileted. R-10 was capable of making that decision, and her wishes regarding her need for toileting would be respected by the CNA. Ms. Ashworth's testimony was generally consistent with her written findings. She met R-10 on the afternoon of October 15. R-10 was lying in bed, and told Ms. Ashworth that she was wet. Ms. Ashworth noted that the call bell cord was clipped to R-10's bed, but that the bell mechanism itself was not within R-10's reach. Ms. Ashworth left the room and took a position at the nurses' station, from which she could see the door to R-10's room. She watched to see if any staff person from Healthpark went into R-10's room. She saw no one enter the room between 2:20 p.m. and 4:15 p.m., at which time she asked a CNA to toilet R-10. Ms. Ashworth returned at 8:55 a.m. on October 16, and observed R-10 sitting in her wheelchair in the hallway outside her room. Ms. Ashworth took up her post at the nurses' station and watched R-10 until 12:05 p.m. At no time in the morning did Ms. Ashworth see R-10 being moved or taken for toileting, though Ms. Joseph testified that she toileted R-10 at about 11 a.m. The evidence established that R-10's room was at the opposite end of a corridor from the nurses' station. The corridor was approximately 200 feet long from the nurses' station to R-10's room. The corridor was busy. Medications were passed at 9:00 a.m., meaning that medication carts went up and down the corridor. Staff carried breakfast trays in and out of rooms. Housekeeping and treatment carts were in the hallway. Given the distance of the nurses' station from R-10's room and the constant activity in the corridor, it is unlikely that Ms. Ashworth's view of R-10 was unobstructed at all times. Moreover, the nurses' station itself was a hub of activity. At the end of the nurses' station where Ms. Ashworth stood was the fax machine. The fax machine was kept constantly busy sending physicians' orders to the pharmacy. The unit secretary was stationed in this location. Nurses passed through this area to retrieve forms from the filing cabinets or to go to the medication room. The likelihood that Ms. Ashworth was unable from her vantage point to view R-10 at all times makes credible Ms. Joseph's testimony that she regularly checked with R-10 to ask whether she required toileting. However, it is unlikely that R-10 was ever out of Ms. Ashworth's sight for the period of seven to eight minutes necessary to actually toilet the resident. Ms. Ashworth's testimony that R-10 was not toileted at 11 a.m. on October 16 is therefore credited. At 12:05 p.m., R-10 was taken to the dining room for lunch. Ms. Ashworth followed and observed R-10 in the dining room. After lunch, R-10 was wheeled back to the outside of her room. Ms. Ashworth observed her from the nurses' station until 2:20 p.m. Ms. Ashworth did not see R-10 being taken for toileting between 12:05 and 2:20 p.m. At 2:30 p.m. on October 16, Ms. Ashworth approached Mona Joseph, the CNA responsible for R-10, and asked her to put R-10 to bed so that Ms. Ashworth could examine her buttocks. Ms. Ashworth asked another AHCA surveyor, Maria Donohue, to accompany her to confirm her observations. There was some delay while Ms. Joseph finished a task for another resident, but eventually Ms. Joseph wheeled R-10 into the room and placed her into bed. Ms. Joseph changed R-10's adult brief in the presence of Ms. Ashworth and Ms. Donohue. Ms. Ashworth testified that there was a strong smell of urine in the room, even before the brief was removed, though she noticed no smell of urine about R- 10 prior to entering the room. When Ms. Joseph removed the adult brief, Ms. Ashworth noted that it was wet and that there was a large amount of feces in the brief and on R-10's buttocks. Ms. Ashworth noted that the skin on R-10's perineum and buttocks was creased and red. The area of R-10's left groin was so red that Ms. Ashworth at first thought there was no skin. Ms. Ashworth stated that this kind of redness is associated with not being toileted as scheduled, though she conceded that such redness can also result from pressure. Ms. Ashworth also conceded that this was her first observation of R-10's buttocks, and thus that she had no baseline to judge how abnormal the redness was at the time Ms. Joseph changed the adult brief. Ms. Donohue also recalled a strong urine smell as soon as they entered the room. She agreed that R-10's buttocks were red in some areas, but recalled no further details. She could not recall if there was feces in the adult brief, but did recall that it was saturated with urine. Mona Joseph, the CNA who changed R-10's adult brief, believed that the urine smell in the room came from the next bed, because she had just changed the adult brief of the person in that bed. Ms. Joseph smelled no odor of urine or feces about R-10. Ms. Joseph testified that R-10's brief was dry, and that she began having a bowel movement while being changed. She noted no redness on R-10's buttocks. Caroline Nicotra was the supervisor of the long-term care unit in which R-10 resided. She knew R-10, and stated that R-10 regularly used her call bell, and would call out for help if she could not reach the call button clipped to her bed. She noted that all of the rooms to which Ms. Joseph was assigned were in the same area of the corridor, so that Ms. Joseph would always be able to hear R-10 call out. There would also be nurses in the area who could hear R-10. Ms. Nicotra knew the surveyors had gone into R-10's room with Ms. Joseph, and she went into the room moments after the surveyors left the room to ascertain whether anything had occurred that she needed to address. Ms. Joseph told Ms. Nicotra what had happened. Ms. Nicotra asked R-10 for permission to examine her body and R-10 assented. Ms. Nicotra removed R-10's adult brief and inspected R-10's buttocks. She observed no creasing or redness of the perineum or the buttocks. R-10's skin was intact and no different than Ms. Nicotra had seen it on other occasions. R-10 told Ms. Nicotra that she was not experiencing pain or discomfort in her buttocks area. Ms. Nicotra stated that R-10 weighed about 180 pounds, and that the creasing and redness observed by the surveyors could have been caused by the pressure of sitting in her wheelchair for a long time. Ms. Nicotra examined the adult brief that had been removed from R-10. She observed that it was slightly damp, which she attributed to sweat, and that it contained a smear of bowel movement. It did not smell strongly of urine. Viewing the evidence in its entirety, and crediting the honesty of the testimony of each witness, it is found that AHCA failed to prove the elements of Tag F224 by a preponderance of the evidence. Ms. Ashworth did not observe R-10 being toileted. However, Ms. Ashworth's observation does not establish that R-10 required toileting or that the facility was negligent in not toileting the resident. After the first meeting on October 15, Ms. Ashworth did not ask R-10 whether she needed to be toileted. Ms. Joseph inquired as to R-10's toileting needs every two hours. R-10 was able to make her needs known to facility staff, and she did so on a daily basis. If her call bell was out of reach, she would call out to staff. Ms. Joseph's testimony that the adult brief was dry of urine and contained only a slight amount of fecal material is supported by that of Ms. Nicotra, the only other witness who actually handled the adult brief, and is therefore credited. The only harm alleged by AHCA was the irritation to R- 10's bottom, claimed to be the result of R-10's sitting in a soiled adult brief for an extended period of time. The surveyors' testimony that R-10's perineum, buttocks, and left groin were creased and red at the time of changing is credited. Also credited, however, is Ms. Nicotra's testimony that R-10's perineum, buttocks and left groin were no longer creased or red a few minutes after the changing. Ms. Nicotra's testimony indicates that the creasing and redness were caused, not by irritation from urine and/or feces in the adult brief, but by an extended period of sitting in her wheelchair. The evidence indicates no neglect of R-10, and that R-10 suffered no harm during the sequence of events described in the Form 2567. II. Tag F325 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 Healthpark allegedly failed to ensure that a resident maintained acceptable parameters of nutritional status. The surveyor's observation on Form 2567 concerned Resident 17, or "R-17": Based on record review and staff (Unit Manager and Registered Dietician) interviews, the facility failed to adequately assess and revise the care plan to address the significant weight loss of 1 (Resident #17) of 15 from a sample of 21 residents reviewed for nutritional concerns. This is evidenced by: 1) After Resident #17 had a significant weight loss of 6.8% in 4 weeks, the facility did not have an adequate nutritional assessment and did not revise the care plan to prevent the resident from further weight loss. The findings include: 1. Resident #17 was admitted to the facility on 9/6/01 with diagnoses that include Sepsis, S/P Incision and Drainage (I&D) of the Right Knee and GI Bleed. The resident has a history of Coronary Artery Disease (CAD). During the clinical record review, it revealed [sic] that the resident's physician ordered Ancef (antibiotic) 2 grams every 8 hours on 9/6/01, to be given for 25 days. During the review of the resident's initial MDS (Minimum Data Set) completed on 9/19/01, it revealed [sic] he weighed 185 lbs (pounds) and is 72 inches tall. Review of the MDS also revealed the resident is independent with his cognitive skills for daily decision making. Further review of the MDS also revealed he requires set up and supervision during meals. He requires extensive assistance with dressing, bathing, and ambulation. Review of the nutritional assessment revealed the RD assessed the resident on 9/10/01. The assessment stated, "Resident has decreased appetite which may be R/T (related to) current meds (medications); Resident's wife feels he has lost wt (weight) but wt is increased due to edema in feet. Resident's current diet meets assessed needs. Will include food preferences to increase intake." Under "Ethnic/Religious Food Preferences" it stated, "No cultural preferences stated." The nutritional assessment completed by the RD on 9/10/01, stated that the resident weighs 185 lbs. His UBW (usual body weight) is 182 lbs. During an interview with the Unit Manager and Registered Dietician (RD) on 10/18/01 at approximately 11:00 AM, they stated that the resident's weight of 185 lbs., which is documented in the initial MDS, was inaccurate. The resident's accurate weight on admission was 175 lbs. During the review of the weight record, it revealed [sic] the resident remained 175 lbs. on 9/11/01. On 9/18/01, the resident weighed 168 lbs., indicating a weight loss of 7 lbs. in 7 days. During the review of the Resident Assessment Protocol (RAP) completed on 9/19/01, it revealed [sic] she [sic] triggered for "Nutritional Status." The care plan developed on 9/19/01 stated, "Res. (resident) leaves 25% or more of food uneaten at most meals. Weight: 168 lbs; UBW (usual body weight) 182 lbs." The goal stated, "Res will maintain weight up or down within 1-2 lbs. through next quarter: 10/17/01." The following approaches are listed: "Diet as ordered." "Encourage fluids." "Monitor weights." "Food preferences and substitute for uneaten foods." "Assist with tray set-ups, open all packages." Review of the physician's order dated 9/18/01 revealed the resident was started on TwoCal HN (supplements) 60cc's four times a day, ice cream everyday [sic] at 8:00 P.M., fruit everyday [sic] at 10:00 A.M. and peanut butter, cracker, and juice everyday [sic] at 2:00 P.M. During the review of the Medication Administration Record (MAR) for the months of 9/01 and 10/01, it confirmed [sic] that this additional supplements were given to the resident, however there is no documentation to indicate the resident's consumption of each supplement. Interview with the Unit Manager on 10/18/01 at approximately 11:15 A.M. also confirmed there is no documentation in the clinical record to indicate the resident's consumption of each snack. Review of the CNA (Certified Nursing Assistant) Care Plan for the month of 9/01 revealed no documentation being offered at bedtime and no documentation for the month of 10/01 that the resident received bedtime snacks. Further review of the resident's weight record revealed the resident weighed 163 lbs on 10/2/01. This indicates a significant weight loss of 12 lbs or 6.8 percent of his total body weight in 4 weeks. Review of the nurses' notes revealed that this significant weight loss had been identified on 9/26/01, 20 days after the resident's admission to the facility. The nurse's notes dated 9/26/01 stated that the care plan to address the risk for weight loss was reviewed. Review of the care plan confirmed it was reviewed on 9/26/01 and 10/6/01. The goal stated, "Will lose no more weight, 11/6/01." Added to approaches stated, "Nutritional supplements as ordered." However, further review of the clinical record and the care plan revealed no documentation to indicate that a comprehensive nutritional assessment was done. There is no documentation in the resident's clinical record to indicate that the care plan was revised. During an interview with the Unit Manager on 10/18/01 at approximately 2:15 P.M., she confirmed that after the resident's admission to the facility on 9/6/01, the resident was refusing to eat, but his appetite improved in the beginning of 10/01. He was consuming 75 percent-100 percent of his meals. She also stated that the resident had "pedal (foot and ankle) edema" on admission to the facility. There is no documentation in the resident's clinical record to indicate that this edema was monitored. There is no documentation in the clinical record that the resident was on a diuretic. She further stated that the final report on the blood culture done on the resident, dated 10/1/01, was positive for Candida sp (yeast infection). During the review of the clinical record, it did not have [sic] documentation to indicate that an assessment of the resident's protein intake was assessed at this time. There is no documentation in the resident's clinical record to indicate that the resident's albumin and protein levels were assessed. During an interview with the Unit Manager on 10/18/01, at approximately 2:15 P.M., she stated that the resident's family members were encouraged to visit more often and encourage to bring foods that he likes. She stated that the resident liked Italian food. This is in contrary to [sic] the RD's nutritional assessment completed on 9/10/01. She also stated that the facility staff continued to honor resident's food preferences and provided alternatives. There is no documentation in the resident's clinical record to indicate that an assessment of the resident's nutritional status, based on his current weight of 163 lbs. and current food intake was done. Further review of the resident's weight record revealed he weighed 158 lbs. on 10/9/01. This reveals a weight loss of 5 more lbs. in 12 days. During the interview on 10/18/01 at approximately 2:15 P.M., she did not have an explanation why the resident continued to lose weight despite an improvement in his appetite. Maria Donohue was the survey team member who recorded the observation of R-17. This resident was initially assigned to Ms. Ashworth, who briefly assessed R-17 in his room and commenced a review of his medical records. Ms. Ashworth noted R-17's weight loss and that his situation required further investigation. Because Ms. Ashworth was busy with her observations of R-10, the survey team shifted responsibility for R-17 to Ms. Donohue. Ms. Donohue based her findings on a review of the resident's medical records and interviews with Healthpark staff. She did not speak to or observe R-17. She did not interview R-17's physician, and could not recall speaking to R- 17's family. R-17 was an 84-year-old male with a history of coronary artery disease who was admitted to Healthpark from a hospital. About a year and a half before his admission to Healthpark, R-17 had a total knee replacement. He was admitted to the hospital because of a fever. A medical work-up revealed that he was septic, with infection throughout his body. The infection stemmed from his knee, and an incision and drainage was performed. The infection was severe, requiring the parenteral administration of the cephalosporin Ancef for a period of 25 days, beginning September 6, 2001. Anorexia is a known adverse reaction to Ancef. Upon admission to Healthpark, R-17 was experiencing pain that was controlled by Percocet, an analgesic with the potential to affect appetite. R-17 was prescribed Zanaflex, a muscle relaxant that can affect appetite. R-17 was also diagnosed as prone to constipation and took laxatives. R-17 also had swelling in his feet and ankles that caused discomfort when he walked. On September 9, an attending nurse documented edema from his ankles to his feet. On September 10, R-17's physician prescribed T.E.D. hose (compressive stockings) for the edema. R-17 refused to wear them. On the same date, R-17's pain increased and his physician ordered a low-dosage Duragesic patch in addition to his other medications. The dosage was increased on September 12, when his pain became so severe that he was screaming out and having spasms. By September 13, R-17's spasms were abating. On September 14, the pain had lessened and he was able to move about, though he continued to voice complaints about the pain. On September 18, R-17 was weighed and it was noted that he had lost seven pounds in the week since his admission. This weight loss was attributed to his pain and the combination of drugs R- 17 was taking, as well as some subsidence of the edema. Healthpark's nursing staff reported the weight loss to R-17's physician, who ordered the snacks and the TwoCal protein drinks described in Ms. Donohoe's observation. The physician visited on September 24 because R-17's pain level had increased and he was again experiencing constipation. The physician ordered blood cultures and Methotrexate for his pain. The physician was making continued efforts to determine the cause of R-17's pain. After the blood cultures were performed, R-17 was referred to a rheumotologist. The blood cultures revealed the presence of another organism in R-17's system besides that being treated with Ancef. On October 2, R-17 was also seen by an infectious disease specialist. R-17's condition improved for about a week. By October 10, the physician was preparing to order his discharge from Healthpark. However, in the early morning hours of October 11, R-17 became confused, incontinent, and had greatly increased pain. His physician ordered new lab work, including a total protein array and electrolyte tests. The record shows that on October 12, R-17 was screaming out in pain and his appetite, which had shown some improvement in early October, was very poor. Though R-17's condition and appetite showed some improvement over the next few days, on October 16 his physician decided to admit him to a hospital to determine the cause of R-17's weight loss and why his pain could not be controlled. Ms. Donohue explained the protocol followed by AHCA surveyors assessing a resident's nutritional status. First, the surveyor determines whether the resident has been assessed comprehensively, adequately, and accurately. If the assessment found that the resident was at risk for nutritional problems, then the facility must determine the interventions necessary to prevent the problems. The surveyor next assesses how the facility implemented the interventions. If the interventions do not work, the facility must show that it has re-evaluated the interventions and reassessed the resident to determine why the interventions failed. The facility must demonstrate that it has looked at all relevant factors, including intake of food and supplements and the resident's underlying medical condition. This re-evaluation and reassessment should lead to revisions in the interventions. The essential allegation under Tag F325 was that Healthpark failed to make a nutritional reassessment after finding that R-17 experienced a significant weight loss over a period of four weeks. Ms. Donohue's testimony at the hearing essentially confirmed her observation on the Form 2567, quoted above. R-17 was weighed weekly, and his weight record confirmed that between September 11, 2001 and October 9, 2001, R-17's weight dropped from 175 to 158 pounds. Lori Riddle, AHCA's expert in dietetics and nutrition, was also involved in the decision to cite R-17's treatment as a deficiency. Her review of the records led her to conclude that Healthpark was aware of R-17's weight loss and put in place approaches to counter that weight loss, but that these approaches were not well planned. Healthpark did not adequately monitor R-17's nutritional intake, such that the record indicated amount of food that was offered but not how much R-17 actually consumed. Ms. Riddle found that Healthpark's approaches were "fairly generic." Healthpark added snacks and nutritional supplements to R-17's diet, but did not indicate in its written care plan whether or how these would meet R-17's nutritional needs. After the initial nutritional assessment on September 10, Healthpark did not formally reassess R-17's caloric needs, even after he began losing weight. Ms. Riddle saw indications in the record that Healthpark recognized the weight loss and stated a goal of maintaining R-17's weight, but saw no recalculation of how many calories would be needed to maintain his weight. Alexandria Antoni was the registered dietician at Healthpark and an expert in the field of nutrition. Ms. Antoni performed the initial nutritional assessment of R-17 and monitored his status throughout the relevant period. She testified as to her relationship with R-17 and her efforts to maintain his food intake. R-17 was very alert and oriented, but had adjustment problems because he had always been an independent, relatively healthy person and had never been in a facility like Healthpark. As a result, R-17 was not receptive to staff's offering food. He did not want to be in the facility at all and resented being bothered by staff. Ms. Antoni noted that R-17 was in much pain and had a hard time dealing with it. The pain affected his ability to sit up or be mobile, and he was on many medications for his pain and infection, any or all of which could have affected his appetite. On her initial visit, Ms. Antoni brought R-17 a copy of the Healthpark menu and reviewed it with him and his family. Ms. Antoni credibly testified that R-17 stated no ethnic food preferences at this initial meeting, though he did tell her that he liked soup at lunch, prune juice in the morning, and a banana on his breakfast tray. Ms. Antoni's initial strategy was to increase R-17's intake by offering foods he liked to eat. His family was there with him every day, and she encouraged them to bring in foods that R-17 liked. Ms. Antoni saw R-17 daily. He would wait for her in the hallway and ask her to come in and tell him what was on the menu. R-17 would often directly phone the kitchen staff to discuss his meal preferences. Ms. Antoni disagreed that R-17's caloric needs were not properly documented. In her initial nutritional assessment, she calculated his caloric needs, based on his height, weight and medical condition, at 1,900 to 2,300 calories per day. She relied on the nursing admission assessment, which listed R-17's weight at 185 pounds, rather than his accurate weight of 175 pounds. Thus, Ms. Antoni's calculation resulted in R-17's getting more calories than his actual weight would have indicated. In her later approaches to R-17's situation, Ms. Antoni kept in mind that R-17 was already being offered more calories than his weight required. She opined that if R-17 had consumed what she calculated, his nutritional needs would have been met and he should not have lost weight. Ms. Antoni could not say why R-17 was losing weight. For the most part, he was eating 75 percent of his meals, which provided between 1,800 and 2,000 calories per day. The TwoCal supplement and the snacks ordered by the physician provided an additional 1,000 calories per day, providing a total well in excess of the 1,900 to 2,300 calorie range calculated by Ms. Antoni. Healthpark staff, including Ms. Antoni and R-17's physician, held meetings every week to discuss the residents' weight status. At each of these weight meetings, Ms. Antoni brought up the subject of R-17's weight loss with his doctor. Ms. Antoni disagreed with AHCA's conclusion that no reassessment was performed. She contended that reassessment occurred at the weekly weight meetings. She followed R-17's caloric intake daily. She could think of nothing else she could have done to increase R-17's weight. Any further action, such as ordering further laboratory tests or a feeding tube, would have required a physician's order. Carol Morris, an RN, was Medicare clinical coordinator at Healthpark and an expert in geriatric nursing. She concurred that the diet ordered for R-17 was adequate to meet his needs. He was cognitively aware, responsive, and could not be forced to eat. Ms. Morris confirmed that Healthpark staff tried to encourage R-17 to eat. The staff gave nutritional advice to R-17's family members so that they could assist in offering him foods that might help his appetite. Ms. Morris noted that pain can be a factor in weight loss. She also observed that the edema would have added to his weight on admission, and its resolution would naturally cause some weight loss. Resolution of his constipation also could have affected his weight. Healthpark staff considered all these factors in care planning to deal with R-17's weight loss. Staff communicated with R-17's physician and with his family on a daily basis. The nursing staff was following doctor's orders, and expected to see R-17's weight stabilize at some point. Ms. Morris testified that Healthpark's assessment of R-17's weight loss took into account his edema, constipation, adjustment to the facility, disease process, and the amount he was eating. She did not think there was anything else Healthpark could have done, given that R-17's physician was also perplexed as to why he was losing weight. Ms. Morris attributed the AHCA citation for failure to document R-17's caloric intake to a simple failure to understand Healthpark's method of charting. The nurses did not explicitly note the amount eaten by R-17 at every meal or snack. The nurse's initials indicated that R-17 ate 100 percent of the meal or snack. An amount was noted only when R-17 ate less than 100 percent of the food offered. If R-17 declined a meal or snack, it was noted and his physician was informed. Ms. Morris testified that R-17's preference for Italian food came up in a conversation with his family, after the nutritional assessment was done. When Healthpark staff saw that R-17 was losing weight, they to the family about what he might like to eat. 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. It is unquestioned that R-17 lost a significant amount of weight during the four weeks from September 11, 2001, to October 9, 2001. However, the evidence does not demonstrate that R-17's weight loss was caused by Healthpark's failure to provide adequate nutrition. To the contrary, the record indicates that R-17 was provided more than enough calories through meals to maintain his weight, and that supplements were ordered by his physician when he began to lose weight. While R-17's appetite was diminished, he continued to consume 75 percent of his meals on average and to take the snacks and TwoCal supplement. Healthpark's staff and R-17's physician were perplexed as to the reasons for his weight loss, with the physician ultimately ordering R-17 admitted to a hospital for further testing as to both his persistent pain and his weight loss. AHCA correctly noted that Healthpark failed to perform a nutritional reassessment of R-17, but the evidence indicates that such a reassessment would merely have constituted a written rendition of the actions the facility was taking. Healthpark was fully aware of R-17's weight loss and reacted in a reasonable manner. Staff encouraged R-17 to eat by offering him dietary options and enlisting the aid of his family. AHCA criticized Healthpark for failure to perform follow-up laboratory tests or to consider a feeding tube for R-17. However, only R-17's physician could have ordered laboratory tests or a feeding tube. The record makes it apparent the physician was concerned with the weight loss, but that his primary concern was R-17's multiple infections and his unexplained and intractable pain. R-17's edema subsided during his stay at Healthpark, which could account for some weight loss. His constipation was resolved to some extent, which could also have had some effect on his weight. R-17 was taking multiple medications, including powerful antibiotics and analgesics, that could affect his appetite. R-17 was having emotional difficulty adjusting to the facility and to his physical condition. Finally, R-17 was cognitively alert and within his rights simply to refuse to eat. Aside from the weight loss itself, R-17 showed no indications of a lack of proper nutrition. Healthpark took all these factors into account in its treatment of R-17. A formal nutritional reassessment would have had no substantive effect on R-17's treatment. At most, Healthpark failed adequately to document the steps it took in caring for R-17 and addressing his weight loss.

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. 02-1788, and rescinding the notice of intent to assign conditional licensure status to Healthpark Care Center in Doah Case No. 02-0033 and reinstating the facility's standard licensure status. DONE AND ENTERED this 6th 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 6th day of September, 2002. COPIES FURNISHED: Lealand McCharen, 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 Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Jodie C. Page, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308

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AGENCY FOR HEALTH CARE ADMINISTRATION vs BEVERLY HEALTHCARE EVANS, 02-000596 (2002)
Division of Administrative Hearings, Florida Filed:Fort Myers, Florida Feb. 15, 2002 Number: 02-000596 Latest Update: Mar. 19, 2003

The Issue The issue in this case is whether Petitioner should change the rating of Respondent's license from standard to conditional.

Findings Of Fact Petitioner is the state agency responsible for evaluating nursing homes in Florida pursuant to Section 400.23(7), Florida Statutes (2001). Respondent operates a licensed nursing home located in Ft. Myers, Florida (the facility). (All chapter and section references are to Florida Statutes (2001) unless otherwise noted.) Petitioner conducted a survey of the facility on August 16, 2001. Petitioner determined that Respondent violated the standards of 42 Code of Federal Regulations (CFR) Section 483.25(i)(1) with respect to the dietary care of residents 20, 6, and 8. Florida Administrative Code Rule 58A-4.1288 makes the federal standards applicable to nursing homes in the state. Petitioner prepared a survey report that sets forth the basis for the alleged violations under "Tag F325." F325 is a shorthand reference to the regulatory standard of the CFR. Petitioner assigned the deficiency in F325 a severity rating of class "II." Section 400.23(8)(b) defines a class II deficiency as one that 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. The surveyors for Petitioner testified that a Class II rating was appropriate because each of the cited residents experienced a significant weight loss that the facility could have prevented with better dietary care. Petitioner changed the license rating for the facility from Standard to Conditional within the meaning of Section 400.23(7). The change in license rating was effective August 16, 2001. The Conditional license rating continued until September 18, 2001, when Petitioner changed Respondent's license rating to Standard. The regulatory standard of Tag F325 requires a nursing home to: 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. 42 CFR Section 483.25(i)(1). The State Operations Manual (SOM) sets forth agency policy with respect to how surveyors are to interpret and apply the regulatory standard of Tag F325. In determining if a facility has maintained a resident's body weight at an acceptable level, the SOM guidelines direct surveyors to evaluate the significance of unplanned weight loss. A significant weight loss occurs when a resident loses five percent or more of his or her body weight in one month, 7.5 percent or more in three months, or 10 percent or more in six months. However, the guidelines caution surveyors that ideal body weight charts have not been validated for the elderly and that weight loss is only a guide in determining nutritional status. If a resident has experienced a significant weight loss, the facility may nonetheless comply with the regulatory standard of Tag F325, if the Resident has clinical conditions that demonstrate that the maintenance of the Resident's weight at an acceptable level is not possible. The SOM indicates that clinical conditions that demonstrate that the maintenance of acceptable nutritional status may not be possible include advanced diseases such as cancer and a Resident's refusal to eat. Even in the absence of an identified disease process, the weight loss is considered unavoidable if the facility has properly assessed the resident, developed a care plan for the resident, consistently implemented that care plan and periodically re- evaluated the care plan. Resident 20 suffered from end-stage Alzheimer's disease and cancer. Like many persons afflicted with end stage Alzheimer's disease, Resident 20 began to refuse to eat food in November 2000. Residents with end-stage Alzheimer's disease refuse to eat because they no longer are aware of the need to eat and do not recognize any hunger pangs. As a result, they typically experience weight loss in their final months of life. As early as October 2000, facility staff determined that Resident 20 was refusing to eat and developed a care plan for her. In November 2000, the facility dietician placed Resident 20 on a high calorie diet that offered her almost 4000 calories a day. The dietician also changed the consistency of Resident 20's diet from pureed to liquid in an effort to get her to consume more calories. However, Resident 20 continued to eat poorly. Resident 20's weight dropped from 151.6 pounds to 147.2 pounds between November 15, 2000, and December 20, 2000. Between December 20, 2000, and January 24, 2001, Resident 20 lost only six tenths of a pound to 146.6 pounds. Resident 20's weight loss during two months between November 2000 and January 2001 was only three percent of her actual body weight. A three percent loss of body weight is not a significant weight loss under the SOM guidelines. The facility dietician did not recommend any changes to Resident 20's dietary care plan for several reasons. Resident 20's weight had stabilized. The dietician believed that Resident 20's refusal to eat was a product of Alzheimer's disease and could not be reversed. Resident 20 had not experienced any significant weight loss. The dietician's decision not to make any revisions to the care plan was consistent with good dietary practice and relevant regulatory standards. Between January 24 and February 28, 2001, Resident 20's weight dropped to 134.2 pounds. The weight loss was 8.5 percent of the resident's body weight. The parties stipulated that this weight loss was significant within the meaning of the SOM. The facility dietician reassessed Resident 20 and concluded that the weight loss was attributable to a refusal to eat caused by Alzheimer's disease. The dietician placed Resident 20 on weekly weight monitoring. The facility dietician correctly determined that there was no dietary intervention that would make Resident 20 consume more food. Both parties acknowledged that an end-stage Alzheimer's patient will progressively decline and that the patient's consumption gets worse, not better, over time. The dietician did not make any recommended changes to Resident 20's dietary orders. Instead, the dietician recommended that staff discuss with the physician and family members the possibility of placing a feeding tube in Resident 20. The facility arranged a meeting with the physician for Resident 20 and family members in March 2001, to discuss the possibility of a feeding tube for Resident 20. The family refused to consent to the placement of the feeding tube in Resident 20. Resident 20 had issued an Advance Directive which prohibited that intervention. Resident 20 passed away on May 7, 2001. The facility did not violate the requirements of Tag F325 by failing to try or even consider new care plan interventions to prevent Resident 20's weight loss between March 1 and May 7, 2001. The facility could have offered Resident 20 smaller portions more frequently, instead of larger portions three times a day, or could have changed the temperature of the liquids offered to Resident 20. The facility could have offered Resident 20 supplements between meals. However, there is no evidence that the available interventions would have been effective. Resident 20's cognitive decline was so severe that it is unlikely the available interventions would have had any positive effect on Resident 20. No regulatory standard required the facility to change the dietary care plan interventions for Resident 20 prior to the significant weight loss in February 2001. The facility provided Resident 20 with every reasonable intervention for the resident's dietary care. Resident 20's diet provided her with more than enough calories. Changing the amount or frequency of food offerings would have had no positive impact on Resident 20's consumption because of the resident's diminished cognitive capacity. The absence of physician's orders for supplements for Resident 20 had no adverse effect. The facility's policy is to offer supplements throughout the day to all residents on the unit in which Resident 20 resided. The facility offered these supplements to Resident 20, but they did not improve her consumption or otherwise stem her weight loss. The facility provided adequate dietary care to Resident 20. The facility offered Resident 20 fluids at three different meal times in addition to supplements throughout the day. Resident 20's appetite and consumption did not improve. The refusal to eat was not related to her distaste for the food offered to her, the quantity of the food offered to her, or the frequency of feeding. Rather, the refusal to eat was a product of her inability to understand what food was and the need to eat. It was thus appropriate for the surveyor to conclude that additional interventions would not have been effective and should not have been employed. The significant weight loss experienced by Resident 20 was unavoidable due to clinical conditions. The SOM guidelines acknowledge that weight loss should be expected in a resident who has a terminal illness or whose diminished cognitive capacity results in a refusal to eat. Resident 20 possessed both of these clinical conditions. The facility admitted Resident 8 in July 2001, for rehabilitative care after surgery for a fractured femur. Upon admission, Resident 8 weighed 106.8 pounds. Her ideal body weight was approximately 98 pounds, and her usual body weight was between 100 and 105 pounds. The admitting body weight may have been high due to swelling in Resident 8's leg. The facility measured and monitored Resident 8's weight weekly for four weeks pursuant to the facility's protocol for all new admissions. The facility dietician assessed Resident 8's food preferences and nutritional needs at the time of admission. The dietician designed a diet to meet Resident 8's needs and preferences. Resident 8 was cognitively alert and physically capable of feeding herself. Resident 8 did not require any special assistance to consume her food other than for staff to set up her feeding tray. Resident 8 was at risk for weight loss due to poor intake upon admission. Facility staff decided not to develop a dietary care plan for Resident 8 because the resident was above both her ideal and usual body weights. The decision not to develop a dietary care plan was within the sound discretion of facility staff. The failure to develop a dietary care plan for Resident 8 did not violate the standard of Tag F325. The dietary plan for Resident 8 maintained the Resident's body weight at acceptable levels for the first three weeks of her stay at the facility. Resident 8's weight on July 25, 2001, was 104.2 pounds. On August 1, 2001, Resident 8's weight was 106.2 pounds. On August 8, 2001, however, Resident 8's weight dropped to 100.2 pounds. On August 9, 2001, the resident's weight was 99.8 pounds. Resident 8's ideal body weight was approximately 98 pounds. The facility discharged Resident 8 on or about August 9, 2001, upon successful completion of her rehabilitation before another weight could be measured. A threshold issue that must be determined is whether Resident 8 experienced a significant weight loss. Respondent stipulated at the administrative hearing that Residents 20 and 6 experienced significant weight losses during their stays at the facility, but refused to concede that point with regard to Resident 8. As noted earlier herein, SOM guidelines indicate that a significant weight loss occurs if a resident loses 5 percent of his or her body weight in the "interval" of one month. The SOM guidelines prescribe a formula for determining the percentage of weight loss. The formula requires usual weight to be reduced by actual weight. The result is divided by usual weight, and that result is multiplied by 100. Resident 8's usual body weight ranged between 100 and 105 pounds when she was admitted to the facility. Use of the high-end of that range in the SOM formula would produce the highest percentage of weight loss for Resident 8. The formula for calculating the significance of the Resident's weight loss produces a number that is less than the 5 percent weigh loss that must be present to satisfy the test of significant weight loss, e.g.: usual weight loss (105) less actual weight (99.9) equals 5.2. The result (5.2) is divided by usual weight (105). The result (.0495) is multiplied by 100 to determine the percentage of weight loss (4.95 percent). The parties stipulated at hearing that Resident 8 lost 6.5 percent of her body weight between July 18 and August 9, 2001. However, that percentage is based upon a comparison of her actual body weights rather than the usual-body-weight formula prescribed in the SOM. Petitioner provided no evidence to justify a deviation from the SOM formula generally used for determining significant weight loss in this case. Even if such a deviation were justified, Resident 8 did not experience a significant weight loss within the meaning of the SOM guidelines. The guidelines indicate that the minimum interval for evaluating a resident's weight loss is one month. Resident 8's actual weight loss occurred in the eight-day period between August 1 and 9, 2001. That is less than the one-month interval established in the SOM guidelines. Even if July 18, 2001, were used as the beginning point for evaluating Resident 8's weight loss, the one-month interval for determining if a significant weight loss had occurred did not expire and would not expire until August 18, 2001. The facility discharged Resident 8 on or about August 9, 2001. Petitioner's surveyor testified that if Resident 8 were to have stayed in the facility for 30 days and if her weight had returned to that present before she began her weight loss, there would have been no significant weight loss. Petitioner provided no evidence that indicated that a resident's weight loss should be evaluated over some time period shorter than the one month period established in the SOM guidelines. Resident 8's case illustrates at least one reason why the SOM guidelines caution surveyors against strict reliance on the amount of a resident's weight loss to determine the resident's nutritional status. Resident 8's body weight never dropped below her ideal body weight while she was admitted to the facility. A weight loss which occurs over a one-week period, and which only results in the Resident dropping to her ideal body weight, does not indicate that the Resident is malnourished. Assuming arguendo that Resident 8 experienced a significant weight loss at the facility, the weight loss was not caused by the failure of facility staff to develop a dietary care plan. It is undisputed that facility staff assessed Resident 8 for her nutritional needs and provided her with an adequate diet to meet those needs. It is also undisputed that, prior to the Resident's weight being taken on August 8, 2001, the facility had no reason to believe or know that the diet that it had prescribed for Resident 8 or the Resident's consumption of that diet might be inadequate. Resident 8's weight remained at or near its admission level under the dietary regimen that the facility prescribed for her for those three weeks. Petitioner was unable to identify one intervention that should have appeared in a dietary care plan that the facility did not actually provide to Resident 8 or that would have prevented the weight loss experienced by Resident 8. The surveyor who developed the allegations regarding Resident 8 is a nurse and not a dietician. The surveyor alleged that Resident 8 was anxious, had been ill when she was admitted, and that the facility had not appropriately assessed whether those factors would affect Resident 8's appetite. Resident 8 did not express such problems to the facility dietician. If it were determined that those problems existed at the time of admission, they were not significant because Resident 8 maintained her usual body weight during the first three weeks of her stay at the facility. When the Resident's weight loss was identified on August 9th, the facility added fortified foods to her diet. Fortified foods are the appropriate dietary response to Resident 8's identified weight loss. The facility provided Resident 8 with all appropriate dietary care. Resident 6 had been a resident at the facility since November 29, 1999. Between May 9 and June 13, 2001, Resident 6 experienced a weight loss of 6.5 percent. The parties stipulated that this loss was significant. However, Resident 6's weight of 152 pounds on June 13th remained above his ideal body weight of 144 pounds. During the period of weight loss, Resident 6 experienced a urinary tract infection for which he was receiving anti-biotic therapy. It is not uncommon for a resident to lose his or her appetite and to have a corresponding weight loss during such treatment. The surveyor for Petitioner who prepared the case involving Resident 6 is not a dietician. The surveyor charged that Resident 6's weight loss was avoidable because the facility failed to assess Resident 6's protein needs after he developed the urinary tract infection and because the facility did not closely monitor Resident 6's food intake. Petitioner offered no evidence to show what additional calorie or protein requirements the facility did not provide to Resident 6. The facility monitored the resident's low consumption levels and attributed them to his antibiotic therapy. The facility dietician is a dietary expert. There is no dietary standard that requires dieticians to reassess a resident's nutritional needs when the resident has an infection. Instead, good dietary practice allows the infection and antibiotic treatments to run their course. Thereafter, the dietician should monitor the resident's consumption and weight to see if he or she returns to normal. The facility dietician assessed Resident 6 after the infection cleared and after the antibiotic treatment had been completed. The dietician determined that Resident 6's consumption was good. The weight loss Resident 6 experienced was attributable to his decreased appetite while on antibiotic therapy. Resident 6's weight remained stable after his infection cleared, and his treatment was completed. Resident 6's ideal body weight is 144 pounds. The facility determined to maintain Resident 6's weight at 150 pounds. The significant weight loss experienced by Resident 6 was the unavoidable consequence of clinical conditions in the form of the illness he experienced and the treatments he received for that illness. The weight loss was not caused by inadequate dietary care by the facility. Moreover, Resident 6 remained above his ideal body weight and, therefore, did not experience any harm. On or about July 12, 2001, the facility obtained an albumin level for Resident 6 of 2.9, which was below the suggested normal laboratory range of 3.5 to 5.0. The surveyor for Petitioner charged that the facility did nothing to address this low lab value but conceded that Resident 6 did not experience any harm as a result of that failure. The SOM guidelines indicate that surveyors should not expect normal lab values for all residents they review because abnormal values are to be expected with certain disease processes. Resident 6 was severely compromised by cardiac problems, dementia, a prior stroke, diabetes, prostate cancer, and Alzheimer's disease. He died shortly after the survey in this case. His albumin level of 2.9 was indicative of his diseased condition rather than his nutritional status. Accordingly, the facility did not violate any standard of good dietary practice when it did not consider or implement dietary interventions for the low albumin level.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a Final Order finding no basis to issue a Conditional rating to the facility on August 16, 2001; deleting the deficiency described under Tag F325; and issuing a Standard rating to the facility to replace the previously issued Conditional rating. DONE AND ENTERED this 6th day of September, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 6th day of September, 2002. COPIES FURNISHED: R. Davis Thomas, Jr. Qualified Representative Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302 Dennis Godfrey, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Sebring Building, Suite 310 St. Petersburg, Florida 33701 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308

CFR (1) 42 CFR 483.25(i)(1) Florida Laws (2) 120.57400.23
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BOARD OF OSTEOPATHIC MEDICAL EXAMINERS vs. MAURICE L. KAYE, 83-003476 (1983)
Division of Administrative Hearings, Florida Number: 83-003476 Latest Update: Jun. 28, 1990

Findings Of Fact The Respondent's name is Maurice L. Kaye. The Respondent's current address is 735-49th Street North, St. Petersburg, Florida 33710. The Respondent is now a licensed osteopathic physician in the State of Florida. The Respondent holds osteopathic license No. OS 0000949. The Respondent was a licensed osteopathic physician in the State of Florida at all times alleged in the Administrative Complaint filed in this cause on August 9, 1983. The Respondent served as the "doctor" at the Florida Medical Weight Loss Clinic from approximately January 15, 1983 until February 10, 1983. The Respondent was employed by Lydia Stein of Florida Medical Weight Loss Clinic. The Florida Medical Weight Loss Clinic placed or caused to be placed an advertisement in the Tampa Tribune dated January 24, 1983. This advertisement failed to conspicuously identify the Respondent by name and failed to conspicuously identify the Respondent as the physician providing medical supervision at the Florida Medical Weight Loss Clinics. The Respondent was vicariously responsible for the dissemination of the advertisement described in the paragraph above. The Respondent caused an advertisement to be placed in the St. Petersburg Times which offered a nonsurgical treatment for cataracts. This advertisement was published on January 10, 1983. This advertisement read as follows: CATARACT TREATMENT NON-SURGICAL FREE CONSULTATION By Dr. Alex Dewart MEDICAL HEALTH CENTER 735-49th Street North 321-3341 The advertisement described above in the St. Petersburg Times failed to conspicuously identify the Respondent by name, failed to identify the Respondent as the responsible physician, and failed to identify the Respondent as an osteopathic physician. The Respondent had no professional or contractual relationship with Dr. Alex Dewart or Alex Duarte, neither of whom were ever employees of Medical Health Center or Respondent at 735-49th Street North, St. Petersburg, Florida. Dr. Alex Duarte is a recognized specialist in non- surgical treatment of cataracts. Evidence was presented concerning the efficacy of non- surgical treatment for cataracts. It is concluded that such treatment may be beneficial and that the extent to which such non-surgical treatment is beneficial is a matter about which reasonable men differ. No believable evidence was presented that the Respondent was unable to assess patients.

Recommendation For failing to identify himself as the responsible osteopathic physician in the Tampa Tribune advertisement contrary to Rule 21R-14.01(2) , Florida Administrative Code and Section 459.015(1)(d), Florida Statutes, it is recommended that the Respondent be fined by the Board the amount of Two Thousand Dollars ($2,000). For having placed the advertisement in the St. Petersburg Times falsely representing that Dr. Alex Dewart was associated with the Medical Health Center contrary to Section 459.015(1)(d) , Florida Statutes, it is recommended that Dr. Kaye's license be suspended for one (1) year and be reinstated upon payment for the fine levied above, and that thereafter Dr. Kaye be placed upon a two (2) year probation period pursuant to Section 459.015(2) , Florida Statutes. DONE and ORDERED this 15th day of January, 1985 in Tallahassee, Leon County, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The Oakland 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 January, 1985. COPIES FURNISHED: James H. Gillis, Esq. Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Maurice L. Kaye, D.O. 735-49th Street, North St. Petersburg, Florida 33710 Ms. Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================

Florida Laws (4) 120.57120.68455.225459.015
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BOARD OF MEDICINE vs DUKE H. SCOTT, 98-000785 (1998)
Division of Administrative Hearings, Florida Filed:Jacksonville, Florida Feb. 12, 1998 Number: 98-000785 Latest Update: Jul. 01, 1999

The Issue The issue is whether Respondent's license as a medical doctor should be disciplined for the reasons given in the Administrative Complaints filed on October 17, 1997, and February 2, 1998.

Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background At all times material hereto, Respondent, Duke H. Scott, was a licensed medical doctor having been issued license number ME 0013791 by the Board of Medicine (Board). Until 1998, Respondent practiced as a family physician at 1205 Beach Boulevard, Jacksonville, Florida. Except for the charges raised in this proceeding, there is no evidence that Respondent has ever been involved in a prior disciplinary action. Based on complaints filed by three former female patients, J. P., B. N., and S. C., Petitioner, Department of Health (Department), prosecuting this matter on behalf of the Board, issued an Administrative Complaint on October 17, 1997, alleging that while treating those patients between the years 1992 and 1994, Respondent improperly exercised influence in the patient-physician relationship for the purpose of engaging those patients in a sexual activity, and he engaged in sexual misconduct in the practice of medicine. Those three complaints are found in Case No. 98-0985. On February 2, 1998, the Department issued a second Administrative Complaint alleging that during the years 1992 through 1995 Respondent engaged in similar activity with two other female patients, C. A. and A. G. Those two complaints are found in Case No. 98-0785. Respondent has denied all allegations of misconduct and requested a hearing for the purpose of contesting the charges. Because the parties presented sharply conflicting versions of events, the undersigned has accepted the most credible testimony and resolved those conflicts in the following manner. Respondent's Practice Respondent has worked as a family practitioner in Jacksonville, Florida, since the 1960's and has treated thousands of patients over the years. When the events herein occurred, he was employed as a physician by Health South, Inc. (HSI), a large medical organization, until HSI was bought out by another entity. In 1992 through 1994, when the alleged misconduct occurred, Respondent's typical day would begin around 5:30 a.m. or 6:00 a.m. when he made "morning rounds" at two local hospitals visiting patients. He then met with his office personnel at 7:30 a.m., and he began seeing patients shortly thereafter. His work day did not end until the last patient was seen, generally between 6:00 p.m. and 8:00 p.m., depending on the case load. In an average day, Respondent saw no fewer than twenty-five, and as many as sixty, patients. The regular staff, which numbered five or six, reported to work each morning by 7:30 a.m. Besides the regular staff, Respondent also hired temporary or part-time workers, often former or current patients, to staff the office after 4:00 p.m. so that some of his regular staff could be relieved. Respondent encouraged these part-timers to complete their education, he paid for their books and tuition while they worked in his office, and he arranged their work schedules around their classes. Because of his full work day, it was not unusual for Respondent to meet with potential part-timers at the end of the work day in his office to discuss possible employment and what their duties would entail. The staff was divided into "front" and "back" staff, which meant they either worked in the front reception area answering the telephone, making appointments, receiving payments, and processing insurance claims, or they worked in the back assisting the doctor when he was seeing patients. As a rule, part-timers worked with the front staff and not with patients. During the early 1990's, Respondent had a fairly large contingent of patients who were on a weight loss program. After an initial comprehensive examination, these patients would return on a periodic basis at 7:30 a.m. for weight and blood pressure checks and a quick visit with Respondent to check on their progress. They remained fully clothed during follow-up visits. Unless they had a specific problem, the patients rarely saw the doctor for longer than a minute or two, and an assistant was always present to keep the patients moving. Beginning around 1985 or so, Respondent had a policy of always having a female assistant in the examination room whenever he conducted a pelvic or breast examination on a female patient. Whenever patients were required to disrobe, they were given a paper gown to wear. It was established that a female assistant would remain in the room until the examination was completed. During a pelvic examination, Respondent always wore a rubber glove on the hand that was being used for the examination. Finally, Respondent kept detailed patient records, and he would never do a breast examination without documenting this in the patient's chart. Unlike most modern era doctors, Respondent occasionally made house calls to family members of his patients when unusual circumstances arose. He followed up on concerns personally, and he treated whole families. In terms of his practicing style, Respondent would sometimes hug his patients, male and female, or even give the females a peck on the forehead before they left his office. This conduct was grounded on his care and concern for the patient, and not for sexual gratification. His style of personally caring for patients has become so rare in today's society that some patients might misinterpret this behavior. The Charges Each of the five patients who filed charges with the Department was either represented in a civil action, or signed an affidavit prepared, by the same Jacksonville attorney. Their claims will be discussed separately below. Patient C. A. In September 1997, C. A. read an article in a local newspaper regarding a civil lawsuit filed against Respondent and certain other defendants by J. P., S. C., and B. N. Motivated by the fact that she could "help out getting [Respondent's] license taken away," she contacted the attorney who was representing the plaintiffs and agreed to sign an affidavit prepared by him. The attorney then mailed it to the Department. She offered no plausible explanation as to why she had waited five years after the alleged misconduct occurred before making a complaint. Respondent's initial contact with C. A. occurred on November 16, 1992, or five years earlier, when she was eighteen years old, after she fell out of a jeep, broke her ankle, and suffered multiple bruises and contusions. Using her parents' health insurance policy, she visited Respondent's office on seven occasions for treatment of her ankle between November 16 and December 30, 1992. She had no complaints regarding his conduct while visiting him for treatment on those occasions. At hearing, C. A. contended that on an undisclosed date in late 1992, at Respondent's invitation, she rode with him to his condominium where they ate a take-out dinner and he mixed her one drink, ostensibly for the purpose of discussing a part-time job at his office. Respondent denied that this occurred. She also claimed that they met several times at his office "after dark," when the office was empty, for "training" sessions. While she felt "uncomfortable" and "weird" in those settings, she conceded that Respondent never raised the subject of sex, never asked her to engage in sexual relations, and never tried to inappropriately touch her. C. A.'s recollection of the alleged events was somewhat hazy. For example, she claimed that Respondent showed her around the condominium, but her description of the condominium was inaccurate. She could not recall the specific dates or times that she visited his office, except that it was after 5:30 p.m., when it became dark. She agreed that it was probably between 6:00 and 7:00 p.m., but if this were true, there would still have been patients or staff in the office at that time, as well as the cleaning crew. She also says that on one occasion, she got some basic training on how to take blood pressure; that training, however, was always given by an assistant, rather than Respondent, and in any event, she would have been hired as "front" staff to meet patients rather than assisting the doctor in treating them. C. A. says that she related Respondent's alleged misconduct to her "mom, stepmother, grandmother, and roommate," and to her present husband, whom she met a few months after last seeing Respondent in December 1992. Except for her husband, no one appeared at hearing to corroborate this assertion. As to the husband, his testimony has been discredited as being biased since he was evicted as a tenant from a rental property owned by Respondent. This occurred after he made an unannounced visit to Respondent's home one Sunday afternoon seeking reimbursement for some painting expenses. During that visit, he banged on the door and windows of Respondent's home until Respondent threatened to call the police and have him arrested. Because of his animosity towards Respondent, it is fair to suspect that he may have motivated his wife to bring these charges or color her testimony. For the foregoing reasons, the testimony of C. A. has not been credited. Even assuming arguendo that the events described by C. A. occurred, there is less than clear and convincing evidence that Respondent exercised influence within this relationship for the purpose of engaging C. A. in sexual activity, as alleged in the complaint. Patient A. G. Like C. A., A. G. read a local newspaper story which detailed the fact that three other patients had filed a lawsuit against Respondent and certain other defendants. She also read that one or more of the actions had been settled for money by the other defendants. After contacting the plaintiffs' attorney, she learned that the statute of limitations barred her from filing a claim. She agreed, however, to sign an affidavit executed by the attorney, who then filed it with the Department. A. G. first visited Respondent in September 1992 to seek assistance in controlling her weight. She was referred to Respondent by her mother, who was also a weight loss patient and a "long time" friend. A. G. continued in the weight loss program for around nine months. In her complaint, A. G. contended that Respondent always asked her to remove her bra, without any attendant being present, while he conducted her follow-up weight loss examinations. Although he never touched her breasts, she complained that she was "uncomfortable" without a top, and that he sometimes positioned himself much closer to her than was necessary. Once, she says he brushed his body against her while examining her eyes and ears. Besides these office visits, A. G. also contended that Respondent approached her to discuss the possibility of her appearing in a scuba diving instruction video he wished to produce. A meeting at his office, however, never materialized. A. G.'s testimony contained many inconsistencies. For example, at one point, she contended that she was asked by Respondent to take off her bra on "every" office visit; she later testified that he asked her to do so on some occasions; she finally testified that this occurred only once. Even then, she conceded that Respondent had never touched her breasts during any office visit. A. G. also recalled Respondent wearing an old fashioned doctor's band with a little silver "thing" on the top of his head. His office staff established, however, that he does not use such a device. The testimony regarding weight checks by Respondent's former office staff was unequivocal that weight patients are fully clothed; that evidence has been accepted as being the most credible on this issue. Visits by weight program patients took no more than a minute or two at most, and an assistant was always in and out of the room to ensure that Respondent moved on to the next waiting patient. In 1995, after having not seen him for over two years, A. G. returned to Respondent's office and requested that he give her a medical excuse to cover an unauthorized leave of absence from her job. Although A. G. denied that this occurred, it was established that she had in fact returned to his office in 1995 and was very angry when she left because Respondent refused to give her the work excuse note that she requested. A. G. also testified that she told her confidant and godmother, Margaret Hightower, about Respondent's alleged behavior. Hightower denied, however, that A. G. ever relayed these alleged incidents to her, and testified that A. G. has a reputation for untruthfulness. For the foregoing reasons, the testimony of A. G. has not been credited. Even one of Petitioner's own experts did not find her testimony to be credible. Accordingly, there is insufficient clear and convincing evidence that Respondent improperly exercised influence in his relationship with A. G. for the purpose of engaging in sexual activity, as alleged in the complaint. Patient J. P. J. P.'s allegations are rather lengthy and involve a number of office visits beginning in late April 1993 and ending in early May 1994. However, she did not have specific recall of which allegations arose from a particular office visit. During her testimony, she relied on notes she had made over two years later in contemplation of civil litigation. In some cases, her testimony was in conflict with contemporaneous medical and insurance records, or with the testimony of other witnesses. In addition, her testimony was seriously impeached as a result of other matters found in the record. For these reasons, her testimony has not been accepted. J. P. initially saw Respondent for hormone and thyroid problems, and emotional distress. She was also treated for a knee injury occuring in May 1993. She was a very large woman weighing approximately 272 pounds. The patient had no complaint regarding her first visit. On her second visit on May 18, 1993, however, she claimed that Respondent examined her without an assistant in the room and attempted to undress her by unbuttoning her blouse and unhooking her bra. She also contended that he examined her breasts unlike any other doctor she had ever visited, including doing so while she sat upright on an examination table and rubbing her nipples until they became hard. Although J. P. contended that the purpose of the second visit was for treatment of an injured knee, the record shows that the original purpose of the visit was to review lab tests and to receive a refill for her thyroid medication. There was no indication in the medical records that a breast examination was performed, and the documentary evidence has been accepted on this issue. Even if one was performed, Petitioner's own expert agreed that it was appropriate to examine her breasts while she was sitting up on the examination table and that it was appropriate and necessary to examine and rub her nipples. J. P. also contended that Respondent performed breast examinations on other occasions even though she was being treated for a knee injury. The medical records do not support this assertion. She also contended that on two occasions, she felt an erection when Respondent brushed up against her during an examination. Like many other doctors, however, Respondent routinely carried an otoscope in his pocket, and it is more likely that the patient felt this instrument if in fact Respondent may have accidentally brushed against her. During a pelvic examination conducted on December 15, 1993, J. P. recalled that Respondent insisted that the female assistant, Frances McLaurin, leave the room. McLaurin disputed that this occurred, and her testimony has been accepted on this issue. When asked why she continued to see Respondent despite the foregoing conduct, J. P. stated that she believed that her insurance company would not allow her to change doctors. The record belies this contention in several respects. For the foregoing reasons, it is found that Respondent did not improperly influence his relationship with J. P. for sexual purposes, or engage in sexual misconduct with the patient, as alleged in the complaint. Patient B. N. B. N. first saw Respondent in March 1979 when she was eighteen years of age. She continued to see him on approximately thirty-five occasions prior to May 1992. She expressed no complaints regarding his conduct during those visits. In April 1992, B. N. began working as an assistant in Respondent's office. She was terminated in October 1992. A few months later, she was rehired on a part-time basis in the late afternoon. This employment ended on August 19, 1993, when she found a full-time job elsewhere. When she left Respondent's employ, B. N. had a disagreement with Respondent regarding her insurance benefits. This was confirmed by a representative of HSI, who was in charge of health insurance benefits. B. N. was under the impression that Respondent had maliciously and intentionally cut her work hours so that she would not be eligible for insurance. As it turned out, though, Respondent had no control over the provision of health insurance to a part-time employee. This bias on the part of B. N. casts doubt on the credibility of her testimony. On May 15, 1992, B. N. claimed that she was disrobed above the waist while no one other than she and Respondent were in the room. She further complained that Respondent touched her forehead while breathing in her ear. She also contended that Respondent stared into her eyes while doing a breast examination, and that he kissed her on the forehead after the examination was completed. Assuming arguendo that the foregoing events occurred, they do not rise to the level of constituting sexual activity or misconduct, as charged in the complaint. For example, Petitioner's expert conceded that it was not inappropriate to stare into a patient's eyes while performing a breast examination. Moreover, the fact that the patient may have felt Respondent's breath while he looked into her ears is not per se an inappropriate activity. Finally, when Respondent gave a female patient a peck on the forehead before she left his office, it was established that this was done out of care and concern for the patient, and not for sexual gratification. On August 10, 1993, Respondent performed a pelvic examination on B. N. after she presented complaints of pain in her lower left quadrant which was enhanced during sexual relations. She was diagnosed with inflammation of the cervix and a bacterial infection of the uterus and vagina. B. N. complained, however, that she felt pressure to her clitoris during the pelvic examination, and she was asked inappropriate questions of a sexual nature by the doctor. As to the first contention, Petitioner's own expert established that given the complaints presented by the patient, it was appropriate for a doctor to touch the clitoris during a pelvic examination, particularly if the patient had complained of pain during sex. As to the inappropriate questions, the same expert testified as to the legitimate medical reasons for the inquiries made by Respondent. B. N. further contended that Respondent performed the vaginal examination without a glove. In light of the more credible evidence presented by his medical assistants on this issue, and Respondent's own testimony to the contrary, this assertion has been rejected. In summary, there is insufficient clear and convincing evidence that Respondent exercised influence within his relationship with B. N. for the purpose of engaging in sexual activity, or that he engaged in sexual misconduct with the patient. Patient S. C. S. C. was a twenty-year-old female when she first saw Respondent as a patient in August 1993. She was taken to see Respondent on August 18, 1993, by her mother, who was also a patient. At that time, she complained of shortness of breath and anxiety. During the comprehensive initial examination, S. C. was asked by a member of the staff to remove her blouse, but not her bra, and she was given a paper gown to wear. During the comprehensive examination, Respondent checked the patient's groin areas for nodes, and he felt the femoral pulses. Although S. C. felt uncomfortable when this occurred, she did not think it was inappropriate. According to Petitioner's expert, this was acceptable conduct on the part of Respondent since there were medical reasons for checking a femoral pulse. S. C. also noted that Respondent cupped her breast while listening to her heart with a stethoscope. However, he never rubbed, caressed, or otherwise fondled her breast, and S. C. never indicated this made her feel uncomfortable or was inappropriate. S. C. was unemployed during this period of time and was looking for a job. At the same time, Respondent needed someone to replace a part-timer (B. N.) who was leaving the next day. Accordingly, he asked her to return later that day to discuss possible employment. When S. C. returned, the office floors were being buffed by the clean-up crew, and it was too noisy to discuss a job. Respondent suggested that they go to his nearby condominum, sometimes used as a rental or loaned to friends, where his wife was cleaning and restocking the unit. This was confirmed by his wife, who was waiting for him at the condominium. On the way to the condominium, S. C. suggested they stop to eat dinner. Since Respondent had already eaten with his wife, he suggested they return to his office on the assumption that the cleaning of the floors was completed. When they returned, one member of the clean-up crew was still present. While in the office, S. C. mentioned that she was having trouble breathing through her nose. Respondent gave her a medication for allergic rhinitis. S. C. recalled that he also performed a quick nasal inspection, and while doing so, Respondent's groin area came into contact with her hands and that he had an erection. She later amended her testimony to state that his groin area came into contact with her knee. At no time, however, did Respondent ever say a word about engaging in sex. Assuming that the above scenario occurred, an accidental brushing up against the patient does not constitute sexual misconduct. Even if S. C. may have felt something brush up against her knee, it is more likely that she felt his otoscope, which he routinely carried in his pocket. S. C. accepted the offer of employment, but she left for Miami shortly thereafter, where her father lived, and she never returned to work for Respondent. In light of the foregoing, it is found that there is less than clear and convincing evidence to indicate that Respondent exercised influence within the patient-physician relationship for the purpose of engaging S. C. in sexual activity, or that he engaged in sexual misconduct with her, as alleged in the complaint.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the two complaints, with prejudice. DONE AND ENTERED this 4th day of May, 1999, in Tallahassee, Leon County, Florida. COPIES FURNISHED: John O. Williams, Esquire Maureen L. Holz, Esquire The Cambridge Center 355 North Monroe Street Tallahassee, Florida 32301 Kelly B. Mathis, Esquire Michael A. Wasylik, Esquire DONALD R. ALEXANDER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 1999. Suite 1700, SunTrust Building 200 West Forsyth Street Jacksonville, Florida 32202-4359 Joseph P. Milton, Esquire 1660 Prudential Drive, Suite 200 Jacksonville, Florida 32207-8185 Robert M. Ervin, Jr., Esquire Melissa F. Allaman, Esquire Post Office Drawer 1170 Tallahassee, Florida 32302-1170 Tanya Williams, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0750 J. Harding Peterson, III, General Counsel Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1701

Florida Laws (4) 120.569120.57458.329458.331 Florida Administrative Code (1) 64B8-9.008
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AGENCY FOR HEALTH CARE ADMINISTRATION vs SHADY REST CARE PAVILION, INC., D/B/A SHADY REST CARE PAVILION, 02-001291 (2002)
Division of Administrative Hearings, Florida Filed:Fort Myers, Florida Mar. 29, 2002 Number: 02-001291 Latest Update: Mar. 19, 2003

The Issue Whether Shady Rest Care Pavilion, Inc. failed to maintain the nutritional status of one of its residents so as to justify the imposition of a conditional license rating upon the facility and an administrative fine of $2,500.

Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings are made: Shady Rest is licensed by the Agency as a skilled nursing facility. Shady Rest's license number is SNF1497096. The Agency conducted an on-site survey of Shady Rest from July 30, 2001, to August 2, 2001. At the time of the survey, Shady Rest's licensure status was standard. The survey was conducted by a "team" that included dietitian Lori Riddle and other health care professionals. The survey team identified several deficiencies at the facility. The deficiencies were detailed on the Form 2567 which was provided to Shady Rest by the Agency. The only deficiency still at issue in this proceeding is the Tag F325 which was summarized on the Form 2567 as follows: Based on observations, clinical record review and staff interviews, the facility failed to ensure that nutritional needs were met for 3 (Residents 11, 21 and 22) of 5 active sampled residents receiving tube feeding who were at high risk for malnutrition as evidenced by significant weight loss, low albumin and total protein levels and recurring pressure sores. The survey team classified the Tag F325 at Level "G" (i.e., isolated actual harm) on the federal scope and severity matrix, which corresponds to an isolated Class II deficiency under the Florida classification scheme. Based upon the cited Class II deficiency, the Agency issued a notice of intent to change Shady Rest's licensure status from standard to conditional, and the Agency initiated a separate action to impose an administrative fine upon Shady Rest. This proceeding followed. At the hearing, the Agency narrowed the focus of the alleged deficiency from the three residents identified on the Form 2567 to only one, Resident 11. No evidence or testimony was presented regarding any other residents. Resident 11 is a female. At the time of the survey, she was 89 years old, 64 inches (five feet, four inches) tall, and weighed 145 pounds. She has been at Shady Rest since 1987. A care plan for Resident 11 was developed by a "team" that included the director of nursing at Shady Rest, a nurse (Sonja Reece, R.N.), a dietitian (Ann Marie Shields, R.D.), two care plan coordinators, and social service and activity personnel. Members of the care plan team worked closely with Resident 11's physician, Dr. Lakshmi Bushan, to manage Resident 11's medical conditions. Dr. Bushan was actively involved with the care of Resident 11 and was very familiar with her conditions. Dr. Bushan was at the facility on a weekly basis and sometimes several times per week. Resident 11 is totally dependent on Shady Rest and its staff for the provision of nutrition. She is fed through a tube connected directly to her stomach. Resident 11 is a "very complex resident" as a result of a myriad of serious medical conditions, including heart attack, seizure disorder, edema (i.e., swelling of the tissues due to fluid retention), hiatal hernia with reflux, pemphagus (i.e., an autoimmune disease resulting in blisters around the body), congestion in the lungs which caused breathing problems, kidney disease, and liver problems. She was also prone to skin breakdown. The treatment of Resident 11 was complicated by the fact that management of one of her conditions would exacerbate another. For example, the Prednisone she was taking to treat her pemphagus increased her fluid retention and, hence, her edema; but, Lasix, the diuretic she was taking for the edema, caused her to have diarrhea which led to the breakdown of her skin from constant cleaning and put her at risk of dehydration and kidney failure. Resident 11's edema was at a dangerous level, referred to as "3+ pitting edema." Relieving the edema was determined to be of critical importance to Resident 11 by her physician. The fluid retention in Resident 11's lungs caused her to suffer from shortness of breath which could ultimately lead to congestive heart failure. Because Resident 11 did not respond well to Lasix and because it actually exacerbated her other medical problems (i.e., skin breakdown), a fluid reduction diet was deemed necessary by her physician. Resident 11 was overweight, partially due to her edema. Resident 11's weight contributed to and exacerbated her medical conditions, particularly her congestion and breathing problems, and it enhanced her risk of congestive heart failure. On April 3, 2001, Dr. Bushan ordered an evaluation of Resident 11's nutritional status and the adequacy of her tube feeding. Resident 11 weighed 163 pounds on that date. On April 4, 2001, Ms. Shields, performed the evaluation ordered by Dr. Bushan. Ms. Shields calculated the total calories per day (cal/day) needed by Resident 11 based upon a standard formula. She then subtracted 400 cal/day to take into account the weight loss desired by Dr. Bushan. Ms. Shields' calculation resulted in an estimated caloric need for Resident 11 of 1,100 to 1,200 cal/day. Because the feeding ordered at that time provided 1,125 cal/day, which was within the range computed by Ms. Shields, no changes were made to Resident 11's diet at that time. Resident 11 was, however, taken off Lasix at that time because it was not contributing significantly to her weight loss and it was putting her at risk for dehydration and kidney failure. Resident 11's weight dropped only slightly after the April 4, 2001, evaluation. On May 1, 2001, she weighed 159 pounds and on June 1, 2001, she weighed 158 pounds. Dr. Bushan wanted Resident 11 to lose more weight more rapidly to stabilize her serious medical conditions. Accordingly, on June 13, 2001, Dr. Bushan requested a dietary consultant to check the amount of Resident 11's tube feedings in order to implement a planned weight loss program to reduce Resident 11's weight to 145 to 150 pounds. Ms. Shields conducted the assessment on June 14, 2001, and after consulting with Resident 11's care plan team, she recommended to Dr. Bushan that Resident 11's caloric intake be reduced from 1,125 cal/day to 750 cal/day to accomplish the rapid and significant weight loss desired by Dr. Bushan. Dr. Bushan accepted Ms. Shield's recommendations and ordered the reduction in calories on June 14, 2001. On that date, Resident 11 weighed 158 pounds. Resident 11's care plan was updated on June 14, 2001, to reflect the goal of reducing her weight by not more than five pounds per week until she reached less than or equal to 150 pounds. The dietary change achieved the desired effect of rapidly reducing Resident 11's weight and stabilizing her medical conditions. Her weight records showed the following: Date June 20, 2001 Weight 153 June 27, 2001 153 July 4, 2001 152 July 11, 2001 153 July 18, 2001 152 July 25, 2001 n/a August 2, 2001 145 The dietary notes for August 1, 2001, indicate that Resident 11's "weight goal was met" and recommended a dietary change to increase Resident 11's caloric intake to 1,000 cal/day. The record does not include the doctor's order implementing that recommendation. However, by August 8, 2001, Resident 11's weight was at 151 pounds, suggesting that the dietary change was implemented. Between the June 14, 2001, dietary change and the August 2, 2001, survey, Resident 11 lost 13 pounds, which is an 8.2 percent weight loss. For the three-month period of May 1, 2001 through August 2, 2001, Resident 11 lost 14 pounds, which is an 8.8 percent weight loss. Resident 11's edema improved significantly during this period; it was no longer at the "3+ pitting edema" level. In this regard, some of Resident 11's weight loss is attributable to the elimination of retained fluids (i.e., reduction in her edema), which was a significant purpose of the weight loss program. The amount of the weight loss attributable to the fluid loss is not quantifiable. The federal guidelines discussing Tag F325, which the Agency's survey team uses in its evaluation of a facility, state that "weight loss (or gain) is a guide in determining nutritional status" and identify parameters to be used in evaluating the significance or severity of weight loss. The 8.8 percent weight loss experienced by Resident 11 over a three- month period would be considered "severe" based upon the parameters. The parameters in the federal guidelines specifically refer to "unplanned and undesired weight loss." By contrast, the weight loss experienced by Resident 11 was planned and desirable. It was directed by Dr. Bushan after Ms. Shield's dietary consultation in order to reduce Resident 11's fluid intake and her edema while also promoting rapid weight loss to minimize her congestion and related breathing problems. The estimated protein needs for Resident 11 were 53 to 57 grams per day. The protein that she was being given, both prior to and after the June 14, 2001, dietary change was within that range. Increasing Resident 11's protein to offset the calorie reduction was not considered a viable option for Resident 11 because her history showed that the more protein she received the more weight she gained. Moreover, too much protein could cause liver failure, which was a risk for Resident 11. When the body is not receiving enough calories, it can metabolize protein as a calorie source rather than for the purposes protein is normally used, such as health of the skin. Resident 11 experienced skin breakdown (i.e., pressure sores or decubitus ulcers) after the June 14, 2001, dietary change. The sores were very small in size and, consistent with Resident 11's past history, the sores healed quickly. Therefore, they are not indicative of a protein deficiency. Indeed, subsequent to the dietary change, Resident 11's skin turgor was good. The laboratory reports for Resident 11 showed her having low albumin levels after the dietary change. Low albumin is generally an indicator of insufficient protein in the body. However, as noted above, the rate at which Resident 11's skin healed suggests that she was getting sufficient protein. Resident 11's low albumin level, in and of itself, is not determinative of her nutritional status. Indeed, the federal guidelines provided to the survey team state: Because some healthy elderly people have abnormal laboratory values, and because abnormal values can be expected in some disease processes, do not expect laboratory values to be within normal ranges for all residents. Consider abnormal values in conjunction with the resident's clinical condition and baseline abnormal values. Even before the June 14, 2001, dietary change, Resident 11's albumin level was not within the normal range. Her abnormal albumin levels may have been the result of her liver problems. Dr. Bushan and the care plan team at Shady Rest managed Resident 11's care based upon their clinical observations of her in conjunction with their experience regarding what worked for her in the past, not simply based upon her laboratory values. They were constantly weighing standards of practice with what was actually happening with Resident 11.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration issue a final order which: Dismisses the Administrative Complaint against Shady Rest Care Pavilion in DOAH Case No. 02-1291; and Rescinds the notice of intent to assign conditional licensure status to Shady Rest Care Pavilion in DOAH Case No. 02-1965 and retains the facility's standard licensure status. DONE AND ENTERED this 26th day of August, 2002, in Tallahassee, Leon County, Florida. T. KENT WETHERELL, II 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 26th day of August, 2002.

Florida Laws (5) 120.569120.57400.023400.121400.23
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