The Issue Whether Respondent is guilty of violation Section 462.14(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the naturopathic physician's professional practice. Whether Respondent is guilty of violating Section 462.14.(1)(n), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient, S.N. Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by failing to perform a statutory or legal obligation placed upon a licensed naturopathic physician, by prescribing a controlled substance to patient S.N. not done in good faith or not done in the course of Respondent's professional practice. Whether Respondent is guilty of gross or repeated malpractice or failed to practice naturopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being appropriate under similar conditions and circumstances, in violation of Section 462.14(1)(t), Florida Statutes. Whether Respondent is guilty of exercising undue influence on the patient or client, S.N., in such a manner as to exploit the patient or client for the financial gain of the licensee, in violation of Section 462.14(1)(o), Florida Statutes. Whether Respondent is guilty of gross or repeated malpractice or failed to practice naturopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being appropriate under similar conditions and circumstances, concerning patients M.C.P., J.S. and M.A. for the following reasons: failure to perform an adequate physical examination or order appropriate tests; failure to adequately monitor the patient; failure to properly supervises the staff of MIWC; and, prescribing legend drugs inappropriately, in violation of Section 462.14(1)(t), Florida Statutes. Whether Respondent is guilty of violating Section 462.14(1)(n), Florida Statutes by failing to keep written medical records justifying the course of treatment of the patients, M.C.P., J.S. and M.A. Whether Respondent is guilty of violating Section 462.14(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, to patients M.C.P., and M.A. other than in the course of the naturopathic physician's professional practice. Whether Respondent is guilty of violating Section 462.14(1)(w), Florida Statutes, by delegating professional responsibilities to a person when the licensee delegating such responsibilities knows or has reason to know that such a person is not qualified by training, experience, or licensure to perform them. Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by allowing the dispensing of drugs not under his direct supervision. Whether Respondent is guilty of violating Section 462.14(1) (h), Florida Statutes, by failure to properly label medical drugs dispensed at the Island Weight Clinic (hereinafter, WIWC) Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by failure to make a complete and accurate inventory of all controlled substances on a biannual basis. Whether Respondent is guilty of violating Section 462.14(1) (1), Florida Statutes, by making deceptive, untrue, or fraudulent representations in the practice of naturopathic medicine by claiming the substance HCG is an effective adjunctive therapy in the treatment of obesity.
Findings Of Fact Many of the medicinal (legend) drugs dispensed at MIWC did not bear labels containing the following information: patient's name; date dispensed; directions for use; or, drug name or prescription number. On May 20, 1986, an inspection was conducted at MIWC. Respondent had not conducted an inventory of all controlled substances at the time at hand on a biannual basis. Respondent's standard practice in regard to new weight clinic patients is as follows: Height, weight, blood pressure and pulse are recorded and blood is taken. Respondent sees patients for about fifteen minutes for an initial examination and they are not seen again by him unless they have problems; each patient is instructed to take their own basal temperature. Patient's blood is checked for hemoglobin, uric acid, cholesterol and blood sugar only; Reports are examined by Respondent if Respondent feels it is needed; Respondent uses practically the same medication for everyone, including: Thyroid pills, HCG or lipotropics, Potassium glucanate, and Ionamin (brand name of phentermine). Vitamin B-6 Folic acid If the patient's blood pressure is elevated the clinic calls Respondent; Clinic staff orders the units of phentermine for delivery at MIWC and another diet clinic in Melbourne, Florida, and dispenses medicinal drugs without direct supervision. Respondent, during the period of time February 10, 1984 through July 1989, has ordered the following quantities of medicinal drugs and controlled substances: Phentermine 8 mg. 31,000 Phentermine 30 mg. 432,000 Phentermine 37.5 mg. 13,000 Thyroid 1/2 grain 1,243,000 Thyroid 1 grain 129,000 Thyroid 2 grain 72,000 HCG 422,000 Potassium 1,170,000 Respondent has provided to weight control patients a printed handout concerning the weight control program. Petitioner has not demonstrated by clear and convincing evidence that HCG is not an effective adjunctive therapy in the treatment of obesity.
Conclusions Based upon the Findings of Fact set forth above, it is concluded that Respondent has committed repeated malpractice and has failed to practice naturopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent, similar physician as being acceptable under similar conditions and circumstances in regard to his treatment of weight clinic patients in violation of Section 462.14(1)(t), Florida Statutes. Respondent's medical records for the weight clinic patients are insufficient to justify the course of treatment of the patients. Therefore, Respondent has failed to keep written medical records justifying the course of treatment of the patients including, but not limited to, patient histories, examination results, test results, x-rays, and records of the prescribing, dispensing and administering of drugs, all in violation of Section 462.140(1)(n), Florida Statutes. Based upon the Finding of Fact above, it is concluded that Respondent has dispensed and administered legend drugs, including controlled substances, inappropriately. Based upon the presumption contained in Section 462.14(1)(q), Florida Statutes, Respondent has dispensed and administered legend drugs, including controlled substances other than in the course of his professional practice in violation of Section 462.14(1)(q), Florida Statutes. Former Section 465.027(2), Florida Statutes (1979), provided in pertinent part: Nothing in this Chapter shall be construed to prevent a practitioner authorized by law to prescribe medicinal drugs from compounding, dispensing, or giving such drugs to his patients in the regular course of his practice. Such compounding and dispensing may be done only by the practitioner himself and shall comply with all Federal and State Laws relating to the labeling and dispensing of medicinal drugs. The provisions of Section 465.027(2), Florida Statutes, were interpreted in two significant opinions. In Parr et al. v. Spires, 41 So.2d 36 (Fla. 1949), the Supreme Court held that a physician's employees, though not registered pharmacists, may lawfully for the doctor's own patients only, dispense, compound and sell any medicinal drugs, provided such dispensing, compounding and selling are done under the doctor's constant and immediate supervision and direction. In addition, in 1963 the First District Court of Appeal in Love v. Escambia County, 157 So.2d 205 (Fla. 1st DCA 1963) stated the language in Chapter 465, Florida Statutes, creating an exception for a physician "himself" dispensing is satisfied where the dispensing is done under the immediate supervision of a physician. The Court stated that the letter and spirit of the statutes is complied with where such dispensing is done under the immediate direction of the physician. In 1986, the Legislature deleted Section 465.027(2), Florida Statutes, and enacted Section 465.0276, Florida Statutes, which provides: A person may not dispense medicinal drugs unless licensed as a pharmacist or otherwise authorized under this chapter to do so, except that a practitioner authorized by law to prescribe drugs may dispense such drugs in the course of his practice in compliance with this section. A practitioner who dispenses medicinal drugs for human consumption for fee or remuneration of any kind whether direct or indirect, must: * * * (b) Comply with and be subject to all laws and rules applicable to pharmacists and pharmacies, including, but not limited to, this chapter, chapter 499 and chapter 893 and all federal laws and federal regulations. It is concluded, therefore, that the Respondent, as a practitioner authorized to prescribe medicinal drugs, (see Section 462.01, Florida Statutes) may dispense the drugs himself to his patients in the regular course of his practice provided he complies with all laws and rules governing the practice of pharmacy. Section 465.003(5), Florida Statutes, provides in pertinent part: "Dispense" means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or his agent. As an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription . . . and he shall certify that the medicinal drug called for by the prescription is ready for transfer. Rule 215-4.002(2), Florida Administrative Code, confirms the responsibility of the pharmacist, and therefore, the physician in the dispensing act and provides: (2) Pursuant to the direction of the licensed pharmacist, pharmacy technicians may assist the pharmacist in the preparation of the prescription. Such pharmacy technician functions include the typing of prescription labels on a typewriter or through entry in a computer system and the entry of prescription information or physician's orders into a computer system. The pharmacist, however, must complete the dispensing act and initial the prescription. Therefore, under both Section 465.027(2), Florida Statutes (1979) and Section 465.0276 (1987), Florida Statutes, Respondent was obligated to personally dispense or to certify that the medicinal drugs called for by the prescription were ready for transfer. In addition, Respondent was obliged to comply with all statutes and regulations governing the practice of pharmacy. Rule 215-1.013(1), Florida Administrative Code, is a rule of the Board of Pharmacy, applying to pharmacies and pharmacists. Said rule provides that labels of all non-controlled substances must include the following information: Name and address of the pharmacy; the name of the prescriber; the name of patient; the date of the original filling or refill date; the prescription number or other prescription information adequate to readily identify the prescription; the directions for use; and, the name of the medicinal drug dispensed (except where the health care practitioner prescribing the drug specifically denotes that the name is to be withheld). In addition, Section 893.05, Florida Statutes, provides in pertinent part: (2) When any controlled substance is dispensed by a practitioner, there shall be affixed to the original container in which the controlled substance is delivered a label on which appears: A date of delivery; the directions for use of the controlled substance; the name and address of the practitioner; the name of the patient; a clear and concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom it is pre- scribed. Rule 21S-1.014, Florida Administrative Code, requires that the prescription department be closed when a licensed pharmacist is not present. Therefore, no drugs can be dispensed in the absence of a licensed pharmacist. Likewise, this regulation would be applicable to dispensing practitioners. Respondent permitted staff members not licensed as pharmacists to dispense medicinal drugs, including controlled substances when he was not present, and had not certified the drugs as being ready for dispensing. In addition, the labels utilized by the Respondent did not meet the requirements of Florida law. Respondent has, therefore, violated the following: Respondent has delegated professional responsibilities to a person when he knew or had reason to know that such person was not qualified by training, experience, or licensure to perform them; to wit, dispensing of medicinal drugs and controlled substances, in violation of Section 462.14(1)(w), Florida Statutes. Respondent has failed to perform a statutory or legal obligation in violation of Section 462.14(1)(h), to wit, by allowing the dispensing of drugs other than under his direct supervision, or in violation of Section 893.05(1), Florida Statutes, and without proper labeling in violation of Florida Statutes and rules set forth above. Section 893.07, Florida Statutes, requires that all practitioners make a complete and accurate inventory of all controlled substances on hand on a biennial basis. Respondent failed to conduct the required inventories. Therefore, Respondent has violated Section 462.14(1)(h), Florida Statutes, by failing to perform any statutory or legal obligation placed upon a licensed naturopathic physician. Respondent has made representations concerning the effects of HCG as an effective adjunctive therapy in the treatment of obesity both verbally and in the printed handout provided to weight control patients on a routine basis. The representations contained in the handout and made to patients have not been shown to be deceptive, untrue or fraudulent, by clear and convincing evidence. Therefore, Respondent is not guilty of violating of Section 462.14(1)(l), Florida Statutes. It is concluded that Petitioner has established by clear and convincing evidence that Respondent has violated the provisions of Subsections 462.14(1)(h),(n),(q),(t) and (w), Florida Statutes. Section 462.14(2), Florida Statutes, provides in pertinent part: (2) When the department finds any person guilty of any of the grounds set forth in subsection (1), it may enter an order imposing one or more of the following penalties: (b) Revocation or suspension of license. (d) Imposition of an Administrative Fine not to exceed $1,000.00 for each count or separate offense.
Recommendation Based on the foregoing findings of fact, conclusions of law and the multiple and continuing violations as demonstrated, it is recommended: That the license of Jesse Alexander as a naturopathic physician be revoked and that an administrative fine of $4,000 be imposed. DONE AND ENTERED this 7th day of August, 1990, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of August, 1990. APPENDIX TO RECOMMENDED ORDER CASE NO. 89-6093 The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings of Fact: Accepted: Paragraphs 1, 2, 3, 4 (in substance), 5, 6, 7, 8, 9, 10, 11, 13 (in substance), 14, 15, 16, 17 (in part), 18, 19, 20, 21, 22, 24, 25, 25(#2), 26, 27, 28, 29, 30, 31, 33, 34, 35, 36 (in part), 37, 38, 46, 48, 49 (in substance) 51, 53 (in part) Rejected: Paragraphs 12 (conclusion of law), 23 (against the greater weight of the evidence), 32, 33, 39 through 44 (repetitious finding), 45 (conclusion of law), 47 (conclusion), 50 (conclusion), 52 (conclusion) 54 (against the greater weight of the evidence) Respondent's Proposed Findings of Fact: Respondent's proposals have been carefully reviewed and incorporated when supported by the evidence. However, Respondent's proposals, for the most part, are a recitation of the testimony of witnesses, documents in the evidence and argument. Therefore, findings of fact 2-4,6-60 are rejected. COPIES FURNISHED: Bruce D. Lamb, Esquire Chief Trial Attorney Department of Professional Regulation, Suite 201 730 S. Sterling Street Tampa, FL 33609 Steven J. Jacovitz, Esquire 43 S. Atlantic Avenue Cocoa Beach, FL 32931 Lawrence A. Gonzalez Secretary Department of Professional Regulation Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 Kenneth E. Easley General Counsel Department of Professional Regulation Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792 =================================================================
The Issue The issue in this case is whether 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
Findings Of Fact Respondent's Exception A.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception A.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception B. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception C. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception D. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception E. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.2. is GRANTED. There is no competent substantial evidence in the record to support the finding, "It has nothing to do with thinness or girth of the Chinese people." Since the burden of proof is on the Petitioner, a lack of evidence by the Respondent on a point cannot be, itself, the basis for a finding of fact against Respondent. Respondent's Exception F.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.5. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exceptions H.1. through H.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (first) is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (second) through I.5. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.2. through J.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.4. is REJECTED for the reasons stated in the arguments of the Petitioner. RULINGS ON EXCEPTIONS TO CONCLUSIONS OF LAW Respondent's Exception A.1. is REJECTED on the basis that the Hearing Officer's analysis is correct. The Board is authorized and required to rule on federal laws and rules, as well as Florida Statutes, such as Chapter 499, which set forth the requirements that licensed medical doctors must meet but which are not within the Medical Practice Act, Chapter 458, Florida Statutes. This Exception is also REJECTED based on the reasons set forth in the Petitioner's argument. Respondent's Exception A.2. is REJECTED based on the written argument of the Petitioner. Respondent's Exception A.3. is REJECTED based on the Department's oral argument and its written arguments to Exceptions A.1. and A.3. to the conclusions of law. Respondent's Exception B.1. is REJECTED based on the arguments set forth by Petitioner. Respondent's Exception C.1. is REJECTED for the reasons stated in the oral argument by the Petitioner and the written argument by the Petitioner in response to Exceptions in C.1 in Exceptions to Findings of Fact and C.1. in Exceptions to Conclusions of Law. Respondent's Exception D. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception E. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons set forth by the Petitioner. Petitioner's reliance on the Rodgers case is misplaced because that case involved full informed consent of the patients and did not involve fraud. Respondent's Exception F.2. through F.3. are REJECTED based on the reasons set forth by the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception set forth as "IV. SUMMARY" is REJECTED as cummulative. See Rule 21M-18.004, Florida Administrative Code. RESPONDENT'S EXCEPTION TO PENALTY 1. Respondent's Exception to penalty is REJECTED. PENALTY Upon a complete review of the record in this case, the Board determines that the penalty recommended by the Hearing Officer be ACCEPTED and ADOPTED. WHEREFORE, IT IS HEREBY ORDERED AND ADJUDGED that Respondent shall pay an administrative fine in the amount of $50,000.00 to the Executive Director within thirty days. Respondent's license to practice medicine in the State of Florida is SUSPENDED for a period of one year. Upon reinstatement from suspension, Respondent's license to practice medicine in the State of Florida is placed on PROBATION for a period of two years, subject to the special condition that Respondent pay $60,000.00 to the Department of Legal Affairs Division of General Legal Services, for use in consumer protection. This Order takes effect upon filing with the Clerk of the Department of Professional Regulation. DONE AND ORDERED this 17th day of August, 1989. BOARD OF MEDICINE FUAD S. ASHKAR, M.D. CHAIRMAN
Recommendation It is recommended that Dr. Willner be found guilty of ten counts of violation of the Medical Practice Act, that he be fined $50,000, and that his license be suspended for a period of one year, and that his licensure then be placed on probation for two years subject to the special condition that he pay $60,000 to the Department of Legal Affairs, Division of General Legal Services, for use in consumer protection. DONE and ORDERED this 7th day of June, 1989, in Tallahassee, Florida. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of June, 1989.
The Issue Whether Petitioner was the subject of an Unlawful Employment Practice by being discharged from his employment due to his handicap, obesity with resulting sleep apnea, in violation of the Florida Human Rights Act, Section 760.10, Florida Statutes.
Findings Of Fact Petitioner was hired as a radiology escort in March, 1981, at Sun Coast Hospital. At that time Petitioner weighed approximately 325 - 335 pounds. The essential functions of Petitioner's job require that he transport patients by stretcher and wheelchair to and from the radiology department, and lift and maneuver up to 300 pounds without assistance. Other primary duties include assisting in the radiographic rooms as needed, removing soiled linen to a designated area, monitoring oxygen tanks, cleaning radiographic rooms and performing dark room duties as needed. In 1985, Petitioner received an average work performance evaluation. In 1986, Petitioner did not meet standards in four out of nine areas. Petitioner needed to improve his work habits and relationships with his coworkers. Petitioner frequently complained when requested he perform special tasks. Petitioner received two counsel sheets in 1986. Counsel sheets are the last stage of the progressive discipline procedure. One counsel sheet arose from Petitioner refusing to perform one of his job duties. The other sheet specified that Petitioner was not performing his share of the work. Petitioner complained about his work, slept on the job, and insisted on taking lunch breaks, even if there was a patient that needed assistance. Petitioner's performance improved in 1987. Nevertheless, Petitioner's self motivation was still below standard. In 1988, Petitioner experienced performance problems once again. Petitioner's 1988 annual evaluation specified that Petitioner needed to increase his productivity and decrease his absenteeism. In addition, Petitioner needed to be more self-motivating. In September, 1988, Petitioner received a written warning for falling asleep in the hospital's front lobby. Petitioner was warned not to sleep on hospital time or work premises. When Petitioner returned with a patient, he was short of breath and sweating. In November, 1988, Petitioner received a written counsel sheet again for his poor job performance. Petitioner was slow, did not do his share of the work, and complained in front of patients. Again, when Petitioner returned with a patient, he was short of breath and sweating. Petitioner insisted on sitting down and resting before he transported another patient. Other employees complained to his supervisor that they could not perform their job when Mr. Engleka was not getting patients to them. In 1988, Petitioner did not indicate that he needed reasonable accommodation. Petitioner's position as an escort was a one person job. Petitioner could not rest in between patients because other employees could not get their work done. Delay resulted in radiological tests not being done in a timely fashion which resulted in delayed patient care. At the request of management, Petitioner was evaluated to determine if he was physically able to perform the essential requirements of his position. Dr. Rea, Respondent's personal physician, determined that continued employment of Petitioner would pose a reasonable probability of substantial harm to Petitioner. Petitioner's labile hypertension, evidence of heart disease, obesity, low blood oxygen levels, and the physical requirements of his job placed Petitioner at substantial risk of having a heart attack and/or stroke. Petitioner's prognosis as it stood was determined to be very guarded to poor. There was no way to decrease the substantial risk of potential heart attack or stroke, but for Petitioner to go on medical leave and lose weight. No reasonable accommodations could be made to enable Petitioner to perform his essential job functions and eliminate or reduce the significant risk of heart attack or stroke to Petitioner. It was decided to recommend that Petitioner go on medical leave and participate in a weight loss program to improve his physical well being which could result in improvement of his work performance. Petitioner was advised that the Hospital was placing Petitioner on a medical leave of absence requiring Petitioner to enter the Optifast Weight Loss Program, and get treatment for sleep apnea. Respondent agreed to and did pay for eighty percent (80 percent) of the weight loss program. Petitioner's last day of work was February 14, 1989. When Petitioner was initially told about the requirement for weight loss, he thought it was a good idea. The next Optifast program started in March, 1989. Petitioner was paid all outstanding vacation, holidays, and sick leave until the Hospital outlined the specifics of placing Petitioner on medical leave. On or about March 24, 1989, Petitioner signed the leave agreement which specified Petitioner would be terminated if he did not comply with the weight loss program. Additionally, the Hospital agreed to assist Petitioner in receiving some income. The document specified that Petitioner understood that he would be replaced in his job. The Optifast program lasted at least twenty-six (26) weeks. Petitioner was expected to be on a leave of absence for at least the twenty-six (26) weeks time period, and return to his position once he completed the Optifast program. Petitioner applied for unemployment compensation in February, 1989, but was denied unemployment when Petitioner told the Unemployment Commission that he was on a medical leave of absence. Petitioner started the Optifast program on March 14, 1989. At that time Petitioner weighed four hundred fifty-three (453) pounds. Petitioner had problems with weight loss program compliance in week 6 (April 18, 1989); week 12 (May 30, 1989); and Week 15 (June 20, 1989) when Petitioner gained more than five (5) pounds. Petitioner stopped attending the Optifast program after week 16, (June 27, 1989), of the 26 week program, and did not see the doctor after that date. A very important phase of a fasting program is the behavior modification phase where eating habits are actually changed so the patient does not regain the weight he lost. Petitioner quit the Optifast program before reaching maintenance. Petitioner was not released, nor did he graduate from the Optifast program. Petitioner did not comply with the Optifast Weight Loss Program, because he stopped the program after 16 weeks. Therefore, Petitioner did not comply with the agreement between himself and Sun Coast Hospital. Petitioner understood that he would be terminated by the Hospital if he did not complete the Optifast program. Petitioner was denied Social Security disability benefits in July 17, 1989. At that time, Petitioner told Ken Deibel, former Director of Human Resources for Suncoast Hospital, that he was in desperate need of some type of income. Deibel told Petitioner the Hospital would change Petitioner's status to layoff so he could receive unemployment. Petitioner immediately received two weeks severance pay in keeping with layoff status. Shortly thereafter, Dr. Rea wrote an undated note stating that Petitioner could return to a working status, in order for Petitioner to qualify for unemployment. Dr. Rea wrote this note after Petitioner complained that he would not be able to continue the weight loss program unless he had a source of income. Dr. Rea did not release Petitioner to return to his position of radiology escort. The note was not addressed to or received by the Hospital. The note did not qualify Mr. Engleka to return to work as an escort at Sun Coast Hospital. Petitioner did not receive unemployment compensation following the change of his status from medical leave of absence to layoff. Petitioner did not restart the Optifast program. Petitioner never brought a release from the Optifast program or told the Hospital that he was ready to return to work. On January 14, 1990, Dr. Rea wrote another letter stating Petitioner could return to a "working status." In January, 1990, when Sun Coast Hospital received the release for Petitioner to return to a "working status," Petitioner was not otherwise qualified for the escort position because he had not lost weight, and still represented a substantial risk to himself. At that time Petitioner had regained almost all the weight that he lost while on the Optifast program, weighing 443 pounds. In January, 1992, Petitioner was diagnosed as having congestive heart failure.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED THAT: That a Final Order be issued which DENIES Petitioner's Charge of Discrimination. DONE AND ENTERED this 26th day of May, 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 26th day of May, 1993. APPENDIX The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on findings of fact submitted by the parties. Proposed Findings of Fact Submitted by Petitioner: Petitioner did not submit proposed findings of fact Proposed Findings of Fact Submitted by Respondent: Accepted in substance: paragraphs - 1, 2, 4-11, 18-20, 21(in part), 22-42, 45-49, 50 in part Rejected as irrelevant or subsumed: paragraphs - 3, 12, 13, 14, 15, 16, 17, 21(in part), 43, 44 COPIES FURNISHED: Robin E. Greiwe, Esquire Thompson, Sizemore & Gonzalez, P.A. 109 Brush North Suite 200 Tampa, Florida 33602 Mr. Michael David Engleka 2826 Oak Lawn Avenue Apartment B Largo, Florida 34641 Sharon Moultry, Clerk Commission on Human Relations 325 John Knox Road Building F Suite 240 Tallahassee, Florida 32303-4149 Dana Baird, Esquire Commission on Human Relations 325 John Knox Road Building F Suite 240 Tallahassee, Florida 32303-4149
Findings Of Fact The Hospital Cost Containment Board has adopted a policy known as the "outlier" policy. Generally speaking, the policy is a credit available to a hospital as a result of the hospital's having experienced a higher level of outlier experience compared to total admissions in one period as compared to another period. The policy has an exception in which a hospital can receive credit in an amendment for a change in outlier experience in a previous year if it files an amendment to its budget within the first ninety days of its current fiscal year. For such amendments, the comparison is between changes in outlier experience which have occurred between two specific timeframes. The first is the change between outlier experience during all the fiscal year two years prior to the current year and the first half of the year prior to the current year. The second is the change between outlier experience in all the fiscal year two years prior to the current year and all of the year prior to the current year. If the second change is greater than the first change, the difference is the outlier credit that is allowed. For an amendment filed after the first ninety days of a hospital's current fiscal year, no credit is allowed for changes in outlier experience from the prior year because in such cases the comparison is between outlier experience which has actually occurred in the current year-to- date compared to the hospital's prior year actual outlier experience. The "outlier" policy described above has been adopted by the Hospital Cost Containment Board as a policy that it generally applies to all hospitals subject to its regulation. The "outlier" policy described above has not been promulgated as a rule in accordance with the procedures established by Section 120.54, Fla. Stat. (1987).
The Issue DOAH Case No. 02-0949: Whether Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 02-1299: Whether Respondent committed the violation alleged in the Administrative Complaint dated February 19, 2002, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: AHCA is the state Agency responsible for licensure and regulation of nursing homes operating in the State of Florida. Chapter 400, Part II, Florida Statutes. Harbour Health operates a licensed nursing home at 23013 Westchester Boulevard, Port Charlotte, Florida. The standard form used by AHCA to document survey findings, titled "Statement of Deficiencies and Plan of Correction," is commonly referred to as a "2567" form. The individual deficiencies are noted on the form by way of identifying numbers commonly called "Tags." A Tag identifies the applicable regulatory standard that the surveyors believe has been violated and provides a summary of the violation, specific factual allegations that the surveyors believe support the violation, and two ratings which indicate the severity of the deficiency. One of the ratings identified in a Tag is a "scope and severity" rating, which is a letter rating from A to L with A representing the least severe deficiency and L representing the most severe. The second rating is a "class" rating, which is a numerical rating of I, II, or III, with I representing the most severe deficiency and III representing the least severe deficiency. On October 22 through 25, 2001, AHCA conducted an annual licensure and certification survey of Harbour Health, to evaluate the facility's compliance with state and federal regulations governing the operation of nursing homes. The survey team alleged several deficiencies during the survey, only one of which is at issue in these proceedings. At issue is a deficiency identified as Tag F325 (violation of 42 C.F.R. Section 483.25(i)(1), relating to maintenance of acceptable parameters of nutritional status). The deficiency alleged in the survey was classified as Class II under the Florida classification system for nursing homes. A Class II deficiency is "a deficiency that the agency determines has compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services." Section 400.23(8)(b), Florida Statutes. The deficiency alleged in the survey was cited at a federal scope and severity rating of G, meaning that the deficiency was isolated and caused actual harm that is not immediate jeopardy. Based on the alleged Class II deficiency in Tag F325, AHCA imposed a conditional license on Harbour Health, effective October 25, 2001. The license expiration date was August 31, 2002. The survey allegedly found a violation of 42 C.F.R. Section 483.25(i)(1), which states: Nutrition. Based on a resident's comprehensive assessment, the facility must ensure that a resident-- Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible. . . . This requirement is referenced on Form 2567 as "Tag F325." The survey found one instance in which Harbour Health allegedly failed to ensure that a resident maintained acceptable parameters of nutritional status. The surveyor's observation on Form 2567 concerned Resident 5, or "R-5": Based on observations, record review and staff interviews, the facility failed to maintain acceptable parameters of nutritional status and did not use all possible interventions, to prevent an unplanned, severe weight loss (7.8 percent in a two month period) for 1 (Resident 5) of 20 active sampled residents. The findings include: During her lunch on 10/22/01 at approximately 12:20 P.M., Resident 5 was observed clinching her teeth together making it difficult to get food into her mouth. Resident 5 was observed on 10/23/01 at 12:30 P.M., taking a limited amount of thickened liquids from her nosey cup, and clinching her teeth together making feeding her more difficult. Resident 5 was observed 5:25 P.M. until 5:55 P.M. on 10/23/01, taking small sips from the nosey cup and clinching her teeth together making it very difficult for the Certified Nursing Assistant (CNA) to feed her 25 percent of her meal. These observations were made in the assisted dining room on A-Wing. Record review of Resident 5's chart, documents 5/1/01 she weighed 127 pounds. On 7/2/01 and again on 7/16/01, her weight was documented 117 pounds. This is a severe weight loss of 7.8 percent in a two month period. Review of the resident's care plan dated 7/18/01, revealed the resident's nutrition problem was "Res. is on a puree diet with thickened liquids-- is continuing to lose weight-- is terminal-- weight is down 6 pounds for the month-- on weekly weight-- consumes 25-50 percent of her meals-- small portions at lunch-- super cereal on breakfast tray and Carnation Instant Breakfast on other trays. Resident can be combative during meals-- resists any attempt to assist her with eating-- is very difficult to feed." Approaches to address the problem included consult with Registered Dietician as needed and to monitor labs. Further review of the care plan included the problem: "Resident is on psychotropic meds for dementia with psychosis as evidenced by . . . increased agitation and resisting care." Review of the resident's physician orders reveal the resident began receiving Risperdal in July 2001 for the diagnosis of psychosis. The record also revealed that the resident was given a terminal status in January 2001. During an interview at 5:20 P.M. on 10/23/01, regarding Resident 5's evening meal being delivered after the other 3 residents at her table, the Certified Nursing Assistant stated, "She don't eat nothing anyway." Interview with CDM (Certified Dietary Manager) and Consulting Dietician on 10/23/01 at approximately 4:45 P.M., regarding resident's severe weight loss and limited nutritional intake, revealed that the Consulting Dietician stated she was unaware of this resident. The CDM stated the resident clinches her teeth, refuses food, and they have tried everything else. She stated that the resident was terminal and that the family did not want a tube feeding placed. The resident was put on thickened liquids by a speech therapist in 1998 for dysphagia, but there had been no speech therapy follow-up. They confirmed that no psychiatric consult was ordered since the care plan was developed, despite continued behaviors during feeding. An interview was conducted with the CDM joined by the DON regarding Resident 5's weight loss and possible interventions on 10/24/01 at 3:05 P.M. It was identified that no routine snacks were ordered, no psychiatric follow-up nor speech therapy follow-up, nor medication adjustments had been done during May 2001 through July 2001. The CDM stated that the facility only acknowledges a 5 percent weight loss at an interval of 1 month, and 10 percent at a 6 month interval as significant, but would not look at a 7.5 percent because it would not trigger on the Minimum Data Set. On 10/24/01 at 3:55 P.M., during an interview with the Unit Manager regarding Resident 5, she stated there was no psychiatric or mental health evaluation ordered, it was only on her care plan. Diane Ashworth was the survey team member who recorded the observation of R-5. Ms. Ashworth based her findings on her observations of R-5, a review of the resident's medical records, and interviews with Harbour Health staff. R-5 was a 92-year-old female who had resided at Harbour Health since 1998. She suffered from dementia with psychosis, in particular end-stage Alzheimer's disease. Her worsening condition caused her physician to request a neurological consultation in January 2001. The consulting neurologist diagnosed her condition as terminal. R-5 was severely impaired cognitively, and was completely dependent on Harbor Health staff for all of her care. R-5 was unable to feed herself. For over three years, Harbour Health has implemented a "restorative dining" program for residents with eating problems. In the restorative dining program, the resident is taken to a quiet area and given one-to-one attention by a CNA during meals. R-5 has been in the restorative dining program since its introduction. During her entire stay at Harbour Health, R-5 was very difficult to feed. She would clench her teeth, cover her mouth and push away. At times she would take the food into her mouth, then spit it back into the face of the caregiver. R-5's medical condition made it impossible to reason with her about the importance of maintaining nutrition. The CNA assigned to R-5 as her restorative aide would spend up to two hours feeding one meal to her. The CNA would attempt to feed R-5 until her agitation and resistance made it impossible. The CNA would refrigerate the food, then wait for R-5 to calm down. Then the CNA would reheat the food and begin the process again. Because of her Alzheimer's and her difficult behavior during meals, R-5 was identified as at risk for weight loss and dehydration. Harbour Health's care plan for R-5 identified several strategies for maximizing R-5's caloric intake, and called for consultation with the facility's registered dietician when needed. R-5 was on a no-sodium-added puree diet, taking thickened liquids in place of solid food. Because she tended to consume only 25 to 50 percent of the food offered at meals, the facility offered her 3,252 calories per day at meals, well in excess of the 1,677 to 1,960 calories required to maintain her usual body weight of 120 to 123 pounds. Staff noted that R-5 appeared overwhelmed by large portions of food and began offering her smaller amounts at one time. R-5 was offered fortified cereals and potatoes, and supplements such as Health Shake and Carnation Instant Breakfast. If R-5 showed signs of accepting certain foods, such as eggs, staff would order extra portions of those foods. Snacks were offered between meals, and R-5 was given vitamin C, zinc, and multivitamins with iron to supplement her nutrition. Staff employed items such as a "Nosey Cup," a cup designed to permit its being held near the resident's face without bumping the nose, to ease the feeding process. Harbour Health's standard practice was to weigh residents once per month. If the monthly weights indicated a problem, then Harbour Health would commence weighing the resident on a weekly basis until the problem was resolved. As noted by Ms. Ashworth, R-5 weighed 127 pounds at her monthly weighing on May 1, 2001. At her next monthly weighing on June 1, 2001, R-5 weighed 123 pounds. At the following monthly weighing on July 2, 2001, R-5 weighed 117 pounds. Ms. Ashworth calculated the weight loss from May 1 to July 2, 2001 as 7.8 percent of R-5's body weight. Noting the weight loss, Harbour Health placed R-5 on weekly weights in July 2001. On July 16, 2001, her weight remained at 117 pounds. On July 23, 2001, her weight had increased to 123 pounds. On August 1, 2001, R-5's weight was 125 pounds. Thus, by early August R-5 had regained nearly all of the weight she had lost between May and July 2001. On July 6, 2001, R-5's attending physician prescribed Risperdal, an antipsychotic medication, to calm her severe agitation and constant movement. Risperdal can act as an appetite stimulant. The administration of Risperdal to R-5 coincided with her weight gain in July 2001. When the facility became aware of R-5's weight loss in July 2001, staff began offering R-5 food more often, including more snacks between meals. The attending physician removed the sodium restriction from R-5's puree diet. Aside from those steps, Harbour Health maintained the same nutritional procedures for R-5. The agency alleged that Harbour Health was deficient in not involving the consulting dietician when it became aware of R-5's weight loss. The agency further alleged that Harbour Health should have ordered a psychiatric consultation and a speech therapy consultation. Regular snacks should have been ordered, and R-5's medications should have been adjusted. Harbour Health contended that it was already doing everything possible to ensure R-5's nutritional status. The only alternative to the puree diet would be tube feeding. R-5's son, who acted as her guardian, made it clear to the facility that he would not consent to tube feeding. In May 2001, R-5 suffered from an upper respiratory infection diagnosed as bronchitis by her attending physician. On May 14, 2001, the physician ordered the antibiotic Levaquin; nebulizer treatments with Albuterol and Atrovent, both bronchodilators; and oral administration of Robitussin. All of these medications were ordered and administered for a period of one week. Harbour Health contended that R-5's respiratory infection completely explained her weight loss. The evidence does not entirely support that contention. The medical records indicate that R-5's condition was largely resolved by the latter part of May 2001. R-5 lost four pounds during the month of May 2001. The majority of R-5's weight loss occurred during the month of June 2001, after her bronchitis was treated and apparently resolved. At most, R-5's weight loss was only partially explained by her upper respiratory infection. Dr. Michael Brinson, R-5's attending physician, testified that it is expected that an end-stage Alzheimer's patient will lose weight, because at some point the resident loses the will to live. In Dr. Brinson's opinion, R-5 had reached this point, which explained her refusal to eat. He was aware of R-5's weight loss. Given R-5's clinical condition, the weight loss did not concern Dr. Brinson, who deemed it irrelevant to her care and treatment. Even Ms. Ashworth, the agency RN who performed the survey observation of R-5, agreed that weight loss can be a symptom of end-stage Alzheimer's. R-5 had been provided with a speech consultation and speech therapy in 1998. She was discharged from speech therapy in March 1998 because it was determined that nothing more could be done for her. Dr. Brinson testified that a speech therapy consultation would have been useless in July 2001. Speech therapy is called for if the resident's refusal to eat is related to a swallowing problem. R-5 had no swallowing problem. Catherine Rolin, the restorative nurse who supervised R-5's feedings, confirmed that there were no indications R-5 had difficulty swallowing, or had choked or aspirated during the time she was losing weight. Dr. Brinson opined that R-5's terminal diagnosis with end-stage Alzheimer's disease made a psychiatric consultation of no value. R-5's cognitive impairment would have rendered her unable to participate in any psychiatric examination. Dr. Brinson came to the facility at least once a week. His Advanced Registered Nurse Practitioner ("ARNP"), Vickie Swank, came to the facility several times a week. Dr. Brinson would have had to order any psychiatric or speech therapy consultation, or any laboratory work. Dr. Brinson believed that none of these was appropriate for R-5. The interdisciplinary team overseeing R-5's care included the facility's certified dietary manager. The team was aware of R-5's weight loss as of July 2, 2001, and decided that R-5's status did not trigger a need to consult the registered dietician. Deborah Blackburn, a dietician and expert in nutrition, reviewed R-5's records and concluded that there was no need to consult a registered dietician. Ms. Blackburn opined that the facility was taking all reasonable steps to maintain R- 5's caloric intake and nutritional status. She could not think of a workable approach that Harbour Health had failed to employ. Aside from the weight loss itself, R-5 suffered no skin breakdown or other negative effects. Viewing the evidence in its entirety, it is found that AHCA failed to prove the elements of Tag F325 by a preponderance of the evidence. R-5 lost the weight then quickly gained most of it back with no dramatic changes in Harbour Health's approaches to her feeding and overall nutrition. This fact demonstrates that R-5's weight loss was caused not by Harbour Health's failure to provide adequate nutrition, but by a combination of R-5's terminal Alzheimer's disease and her upper respiratory infection. Once Harbour Health became aware of the weight loss, it reacted appropriately and successfully. The steps that the agency faulted Harbour Health for failing to take--psychiatric consultation, speech therapy consultation, dietician consultation, and medication adjustments--were demonstrated to be unnecessary in light of R-5's condition.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint in DOAH Case No. 02-1299, and rescinding the notice of intent to assign conditional licensure status to Harbour Health Center in DOAH Case No. 02-0949 and reinstating the facility's standard licensure status. DONE AND ENTERED this 23rd day of September, 2002, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 2002. COPIES FURNISHED: Ursula Eikman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dennis L. Godfrey, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310L St. Petersburg, Florida 33701 Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valinda Clark Christian, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue Whether Beverly Health Care of North Okaloosa violated certain regulations at the time of two surveys conducted on July 16 and November 29, 2001, so as to justify the Agency for Health Care Administration's decision to issue Beverly Health Care of North Okaloosa Conditional licenses and administrative fines.
Findings Of Fact North Okaloosa is a licensed nursing home located in Crestview, Florida. On July 16, 2001, AHCA conducted a survey of North Okaloosa’s facility. In its survey AHCA found one alleged deficiency relating to Resident No. 5. The deficiency was cited under Tag F-324. Tag F-324 relates to whether a facility has provided sufficient supervision or assistive devices to a resident to prevent injury from falls. The tag does not address assessment, the failure to assess, or maintenance of a care plan. These deficiencies are covered by other tags. Specific to Resident No. 5, the agency surveyor suggested that Resident No. 5 should have been provided a different type of footwear from that which he was wearing or that the facility should have provided additional assistive devices to prevent falls. Resident No. 5 was admitted to North Okaloosa’s facility around April 16, 2001. At the time of admission, he was assessed as being at high risk for falls. Interventions included monitoring medications, laboratory values, steadiness and balance. Resident No. 5 resided on the secured ward at the facility. Resident No. 5 had pain in both feet, but could ambulate. He walked with a shuffling gait due to his foot pain, and he wore slip-on house shoes without non-skid soles. He refused to wear other types of shoes because other types of shoes caused more discomfort. He was also cognitively impaired and refused to sit down or lie down to rest but would ambulate continuously. Restraints were not appropriate for him. Resident No. 5 had been assessed to be at risk for falling and had a care plan in place. He was on the facility’s "Falling Star" program which meant that he was checked on by the staff at least every half hour. The general standard of observation in nursing homes is every two hours. The nurses’ notes contain many entries regarding monitoring the resident while he walked. Since admission, Resident No. 5 fell on June 12, June 25, July 8, and July 14, 2001. The only falls charged as violations by AHCA concerned the falls on July 8 and July 14, 2001. The resident was found on the floor outside the shower on July 8, 2001. He sustained some injury which caused him to be taken to the local hospital. However, there was no indication of inappropriate supervision or that his shoes were involved or contributed to the fall. Indeed, there was very little evidence regarding how Resident No. 5 got down on the floor of the shower. Resident No. 5 fell again on July 14, 2001. On that date, he was being observed by staff who saw him bend over and then lose his balance. At that time, he was being supervised closely, but even so, the fall could not be prevented. Again, there was no indication that the shoes contributed to his fall. Unfortunately, falls are a common occurrence in nursing homes and cannot always be prevented. The goal is to balance the need to prevent falls and the need to keep residents free of restraints given physical, cognitive, and treatment limitations. Falls can result regardless of adequate supervision. There is no standard of care which requires one-on-one supervision of any resident. However, such one-on-one supervision would not necessarily prevent all falls. Although AHCA suggested the resident should have had shoes with non-skid soles, such shoes would have increased the risk of falls, given the resident’s shuffling gait. Non-skid soles were not appropriate footwear for Resident No. 5. There was some indication in the evidence that the facility at times had one C.N.A. on duty for the ward. No schedules or testimony from the facility confirmed this fact. There was insufficient evidence on this point to address the adequacy of the facility's staffing. Moreover, the evidence did not demonstrate any appropriate measures which could have been added to protect Resident No. 5 from falls. Beyond agency speculation, there was no evidence that the standard of care for supervision of a resident in order to prevent falls was violated and no Class II deficiency occurred in relation thereto. On November 29, 2001, AHCA again conducted a survey of North Okaloosa’s facility. In its survey AHCA found several violations related to various residents. The deficiencies cited by AHCA involved Resident No. 3 (Tags F-157 and F-324); Residents No. 2 and 22 (Tag F-221); Resident No. 19 (Tags F-221, F-324 and F-325); Resident No. 7 (Tag F-279); Residents No. 10 and 12 (Tags F-279 and F-325); Resident No. 15 (Tag F-279); Resident No. 16 (Tags F-279 and F-324); Resident No. 24 (Tag F-279); Resident No. 25 (Tag F-324); and Residents No. 1 and 17 (Tag F-325). Tag F-157 represents 42 C.F.R. Section 483.10(b)(11), which in pertinent part requires a facility to immediately inform a physician "when there . . . is a significant change in the resident’s . . . status . . . (i.e., a deterioration in health . . . status in either life threatening conditions or clinical complications) . . ." Not all changes in a resident’s condition trigger the notification provisions of Tag F-157. Notification is required only where the change is significant as outlined above. Resident No. 3 required assistance with her activities of daily living and was cognitively impaired. Resident No. 3 required assistance with ambulation. There was no evidence that she required assistance with toileting. She was diagnosed with dementia and had severe osteoarthritis. Resident No. 3 often complained of back pain and was prescribed Darvocet as a medication for her back pain. She also often refused to ambulate and would remain in her bed. She was prescribed Zyprexa and Haldol. Nursing notes indicate that at 7:23 p.m. on August 31, 2001, Resident No. 3 was assisted to the bathroom and seated. A few minutes later she was found "on the floor no injuries noted." Nurses are trained to assess patients after an accident to determine whether there has been an injury. This is a regular part of practice in a nursing facility. A notification was faxed to the doctor regarding the incident, with the notation that there was no injury, but that the resident had experienced a decline in ability to ambulate. However, the staff did not think the decline was a significant change in status since Resident No. 3 often would stay in bed. AHCA asserts that this notice was insufficient, as it was sent after office hours prior to a weekend. AHCA’s position assumes the doctor would not have received the fax. The nursing notes over the weekend note that the resident complained of back pain, that she had a small bruise on her left shoulder, that she remained in bed but displayed no effects from the fall. Nursing staff continued to monitor her. On Saturday and Sunday, the C.N.A. did range of motion and ambulation exercises with the resident. There was no complaint of pain or "guarding." On the following Tuesday (Monday was Labor Day), while in therapy, the therapist noted pain while doing exercises. The physician was called and an X-ray was ordered which revealed a fracture of the tibia. In this case, the complaint of back pain did not constitute a significant change in condition, as the resident’s record is replete with continuing complaints of back pain prior to August 31, 2001, and a medication prescribed for that particular problem. The resident had also had episodes of staying in bed and a recent decline in ambulation, of which the doctor was aware. Given this history, the clinical records do not reflect any significant change in condition which would warrant an immediate notification of a physician prior to Tuesday, when the doctor was called. Therefore, no Class II violation occurred in relation to Resident No. 3 under Tag F-157. Tag F-324 was also cited as a violation in relation to Resident No. 3. As indicated earlier, Tag F-324 relates to the provision of adequate supervision or assistive devices to prevent falls. The record reflects that the resident had been able to ambulate independently with a recent decline in ambulation and need for some assistance. She could follow instructions. She had a care plan for falls and was on the Falling Star program. She was seen by a neurologist and a physical therapist. Nothing in the record indicated insufficient capacity to be allowed to use the bathroom in private. AHCA's surveyor did not know what the usual routine was for this resident as it related to toileting but suggested that she should not have been left alone while toileting. The evidence does not support this conclusion and there is no other basis under this tag in relation to Resident No. 3, which demonstrates a violation. Tag F-221 corresponds to 42. C.F.R. Section 483.13(a) and prohibits the use of restraints "imposed for discipline or convenience and not required to treat the resident’s medical condition." Again, the tag does not include assessment, failure to assess or maintenance of a care plan. AHCA asserted that three residents had restraints which were not used to treat a medical condition, Residents No. 2, 19, and 22. Resident No. 2 had a history of falls, and a care plan to address his risk of falls. On October 17, 2001, he fell for the third time since September 30, 2001, causing a 3.5 cm laceration to the back of his head. He had been experiencing a decline in cognitive status and disease progression, of which the doctor was aware. The resident had severe mental impairment which caused him to not be aware of safety. As a result of this history and his injury, the doctor assessed and ordered the use of a lap belt while he was in a wheelchair, along with an alarm to notify staff if he attempted to stand. The records reflect a medical need for the restraint to prevent injury to this resident. Resident No. 19 used a front opening lap belt while she was in her wheelchair. The lap belt was assessed and ordered by the physician on August 14, 2001. The clinical record contained an assessment of the device and approval from the family, but the assessment clearly noted that the device was used "for positioning. Not as a restraint." The resident had a care plan for falls, which also stated that the seat belt was for positioning to "prevent her from sliding out of the chair," not to prevent her from getting up. According to the notes of her assessment, the belt also acted as a reminder for her to seek assistance when getting up. AHCA acknowledged that the device was not a restraint because the resident could, and did, open it. Even if it were considered a restraint, however, the record reflects that it was used to address her history of falls and poor safety awareness due to her dementia. In short, the belt was used because of her medical condition and, therefore, had a medical reason underlying its use. Resident No. 22 had a physician’s assessment and order for a roll belt while in bed. A roll belt is attached to either side of the bed and keeps the resident from getting up or out of bed. It is a restraint. The roll belt was ordered because, as acknowledged by AHCA in the survey report, the resident had sustained a fall in which she broke her hip, and then, upon return to the facility, fell from her bed and re-injured her hip. The second fall necessitated a complete hip replacement. She had poor safety awareness, and any further fall would have resulted in severe limitations. The doctor had also ordered cushions to be attached to her legs to keep her hip aligned properly, so that any attempt to get up would necessarily have resulted in a fall. Clearly, this restraint had a medical purpose. As to Tag F-221, there was insufficient evidence that North Okaloosa used restraints in an inappropriate manner. It was clear from the evidence that AHCA’s main concern was a perceived lack of assessment or reassessment of the devices used on these residents. However, assessment is not covered by this tag. Moreover, the record demonstrated some assessment was done by the doctor in ordering the use of these devices for medical reasons. The facility is entitled to rely on that expert's decision. Tag F-279 encompasses 42 C.F.R. Section 483.20(k), which requires a comprehensive care plan for each resident to meet needs identified in a comprehensive assessment. AHCA asserted that the care plans for six residents were defective in varying ways. AHCA's surveyor asserted that the care plan for pressure sores for Resident No. 7 was deficient because it did not mention that the resident was at high risk for pressure sores, that he had sores that opened and healed, or included the changes in the doctor’s orders regarding those sores. A "care plan" as opposed to a "plan of care" is developed pursuant to an assessment called a Minimum Data Set or MDS, which is conducted on admission, then annually with quarterly updates for significant changes. It is not an all- inclusive document and cannot be all-inclusive. As set forth in Rule 59A-4.109, Florida Administrative Code, the overall "plan of care" includes not only the care plan, but physician’s orders and other information relating to the resident. Physician orders are not required to be included in the formal care plan required under Tag F-279 and such orders are not typically reflected on a care plan document. Resident No. 7 was admitted with Stage IV pressure ulcers in February 2001. Resident No. 7 was diagnosed with leukemia, as well as other debilitating conditions. A care plan was developed in March pursuant to an MDS on admission which stated that he had pressure sores and was at high risk for developing such. The plan was amended several times, most recently before the survey on November 14, 2001. Contrary to the surveyor’s assertion, the care plan did mention the resident was at increased risk for pressure sores and noted that, in spite of the resident’s conditions, the pressure sores healed by May and did not reoccur. The care plan was kept in effect to prevent further problems and was obviously effective. Clearly, Resident No. 7 had a care plan which reasonably addressed his needs. AHCA asserted that Resident No. 10 required a care plan for weight loss. However, the resident was admitted at 80 pounds, and at the time of the survey weighed 93.6 pounds, indicating that there was not a weight loss problem. A physician’s assessment in September described her as a "petite, well-developed" 87-year-old, which indicates no problem with her weight. She was within her ideal weight range. She had some history of up and down weights, but the evidence did not demonstrate a need to change or update Resident No. 10’s care plan. Resident No. 10 had also been flagged by the facility as being at risk for weight loss and sometimes refused her meals. However, these facts demonstrate an appropriate ongoing monitoring and assessment of Resident No. 10 by the facility. These facts do not demonstrate a need to immediately amend the formal care plan for Resident No. 10. Resident No. 12 was a Hospice patient. He had metastatic prostate cancer which was likely to result in death within six months. For Hospice residents, the focus is on comfort as opposed to aggressive care. The Hospice agency is a separate entity from the nursing home, and when Hospice comes in to care for a resident, it becomes the care manager and determines the approaches to care. AHCA's surveyor asserted that there did not appear to be coordinated care plans between Hospice and North Okaloosa for Resident No. 12, but the basis for this concern was not made clear. AHCA's surveyor acknowledged that the facility and Hospice had care plans and did not identify any specific concerns except that the facility did not appear to be doing weekly weighings of the resident. However, Resident No. 12 had been assessed to be likely to lose weight due to his medical conditions. He received nutritional supplements, and the family had declined tube feedings, which is consistent with Hospice care. The facility records reflect that the resident did receive the nutritional supplements, and that, while he gradually lost weight as expected, he did not decline significantly in the period prior to survey. The facility did not shirk its duty to continue to monitor Resident No. 12. It coordinated its care with that of Hospice and AHCA’s concerns over such were not born out by the evidence. AHCA’s complaint about Resident No. 15 was that the care plan for weight loss was discontinued when the resident was admitted to Hospice care. At that time, however, the resident continued to have a Hospice care plan regarding nutrition, and a facility care plan regarding hospice care which noted that the resident was to be monitored for abnormal weight loss, appetite, and skin breakdown. Additionally, as a result of an assessment completed November 26, 2001, it was determined that there were concerns about skin breakdown. A separate care plan for nutritional status was to be developed. This assessment demonstrates that the care planning process was working appropriately for Resident No. 15. It also demonstrates coordination between Hospice and the facility. Again, AHCA's concern of coordination of Hospice care with facility care was not born out by the evidence. Resident No. 16 was diagnosed with various dementias, anxiety and depression. The resident had frequent episodes of dizziness with a history of falls. AHCA's surveyor asserted that the care plan for Resident No. 16 should have had particular mention of dizziness and a method of addressing that condition. The care plan did appropriately plan for fall prevention and addressed the reasons for her falls, i.e. vertigo, under that section. The resident’s record demonstrates that the resident received frequent physician attention due to her spells of dizziness or vertigo and that the nurses continuously monitored for that condition. The assessment which resulted in the development of the resident’s care plan indicates that the resident has dizzy spells causing falls. The care plan lists monitoring of the resident for "steadiness and balance." As "dizziness" is a subjective state, it cannot be monitored, and the care plan, which was updated on many occasions, adequately addressed the problem even if it was not in terms AHCA thought should be used. Resident No. 24 was also a Hospice resident. The resident was in a vegetative state. AHCA's surveyor suggested that the Hospice care plans and facility care plans were not "integrated." The resident’s record reflects, however, that the facility developed a care plan noting that the resident was on Hospice care and that Hospice attended care plan meetings. AHCA also suggested that the care plan for pressure sores was deficient because it noted a "risk of" pressure sores and was not updated to reflect actual pressure sores which the resident acquired while in the hospital. AHCA suggested no way in which this would have changed the care given. However, as noted above, physician orders are not typically reflected on the care plan document. Furthermore, Hospice had a care plan for pressures sores as well, and the record reflects that there were numerous physician orders for treatments. The care plans for all the residents cited were developed pursuant to the comprehensive assessment process. The evidence did not demonstrate any Class II violations of Tag F-279. Indeed the evidence demonstrated that confusion by AHCA over a resident’s formal care plan with an ongoing and changing plan of care. Again, in the November survey AHCA charged that North Okaloosa failed to provide adequate supervision to prevent accidents for three residents under Tag F-324. The allegations relating to Resident No. 3 were covered earlier. As indicated earlier, Resident No. 16 experienced dizziness or vertigo. She also had a high risk for falls. AHCA's surveyor speculated that alarms should have been attached to her chair or increased supervision. However, the resident regularly got up and walked, which would render the alarms useless. Indeed, the evidence did not demonstrate that rising from a seated position was the cause of her falls. In fact, the resident had not experienced any falls from August 22 until November 27, 2001, in spite of her episodes of vertigo and dizziness. She received frequent physician evaluations and the nurses’ notes reflect frequent monitoring. The record reflects that there was no warning of her attacks of vertigo. There was no evidence of inadequate supervision or of assistive devices which would reduce the resident’s risk of falling. Resident No. 19 had a history of falls and had been assessed several times for the problem. He was in a wheelchair with a front opening seat belt. A TABS monitor was used while the resident was in bed. The resident had a care plan in place to address such, including restorative care to assist with transfers. She received therapy to address her problem with balance. AHCA's surveyor suggested that her seat belt did not operate as an effective restraint but did not suggest the resident should have been restrained, agreeing that residents generally have the right to be free of restraints. Indeed, restraints were not appropriate for this resident. AHCA also noted that no measures other than a seatbelt and chair alarm had been put in place since August. Those measures had been reviewed through assessment in September, however, and had been effective in preventing falls until November 23, 2001. There was no evidence that there was any lack of supervision of Resident No. 19. Additionally, the resident was in the process of being reassessed to determine if further interventions were appropriate after her fall of November 23, 2001, and that review, though underway, had not been completed at the time of the survey. The evidence did not demonstrate that AHCA failed to adequately supervise or provide assistive devices to these residents. Therefore, no Class II violation under Tag F-324 was established. Tag F-325 requires a facility to ensure that a resident "maintains acceptable parameters of nutritional status" insofar as possible given a resident’s clinical conditions. 42 C.F.R. Section 483.25(i). Guidelines used by AHCA in interpreting this regulation are found in the State Operations Manual and suggest that there are levels of "significant" weight loss which would be unacceptable, if not explained by a resident’s medical circumstances. Weight loss is to be determined by looking to the resident’s usual weight, and significance is measured at one month, three month, and six month intervals, recognizing that a shorter term could be a temporary aberration. Generally, a 5 percent total body weight loss in 30 days or a 10 percent total body weight loss in 180 days is considered significant by AHCA. However, these are simply guidelines and do not necessarily demonstrate a violation of this tag. Other considerations, such as the resident’s medical condition and obesity, must be considered. AHCA asserted that Resident No. 1 had a significant weight loss, from 249 to 222 pounds from September 16 through October 9, 2001. The selection of this time period is inappropriate, however, for two reasons. One, the weight of 249 is clearly, by the weight records, not a usual weight and appears to be a mistake. The resident’s prior weight was 238, and the resident’s usual weight was between 220 and 230 pounds. The resident was obese, which can make weighing difficult and cause inaccuracies. Moreover, it is physically impossible for the resident to have lost 27 pounds in three weeks. The second reason that the noted time frame was inappropriate was that it spanned less than a one month’s time and, therefore, was not necessarily indicative of any trend or condition. The surveyor also opined, though she was not a dietician or physician, that the facility should have increased the resident’s tube feeding level prior to October 9, 2001. The level had been reduced on physician orders on September 24, 2001, due to nausea and vomiting. The resident had metastatic breast cancer and was on Hospice care, making comfort the primary goal of treatment. From that date until October 9, 2001, the clinical record reflects continuing reasons not to increase the feeding level, irrespective of the dieticians recommendations. Medications had been added, and monitoring for their effectiveness would take time. The resident also had a distended abdomen indicating a failure to absorb the feedings she was receiving. Even if there had been a weight loss, it was not inadvisable given the resident’s obesity. There was no evidence that the resident’s nutritional well-being was not being monitored appropriately by the facility. AHCA cited Resident No. 10 under Tag F-325, but did not identify any "parameter of nutritional status" which was not maintained. Again, the surveyor identified a short term (one week) weight loss, which was not significant. The resident was within her ideal range. The surveyor suggested only that she had a history of varying weights and that, during the survey, she did not eat some of her meals. The weight record reflects, however, fairly consistent weights and an overall increase from the time of the resident’s admission. It was not disputed that Resident No. 12 experienced a significant weight loss; however, it was also undisputed that weight loss was to be expected with his metastatic prostate cancer, other medical conditions, and Hospice status. The surveyor was concerned that the resident was seen with a regular meal, rather than a "mechanical soft" meal, as ordered, and that the meal tray did not contain a sugar free shake, as ordered. The description of the meal in the survey report identified a meal which is considered "mechanical soft" by dietary standards. Further the clinical record (medication administration record) demonstrated that the shakes were provided. The shakes were not required to be on the meal tray, as there was a one-hour window around mealtime in which they could be served. Furthermore, the resident’s weight in October and November was relatively stable. The resident’s weight loss and protein levels were the result of his medical condition and the resident was on an adequate diet given the parameters of the resident’s treatment and condition. Resident No. 17 was cited under this tag, though there was no evidence of any significant weight decline or other nutritional deficit. The resident was within her ideal body weight and gained weight during her stay at North Okaloosa. AHCA disputed the tube feeding provided to the resident, but was unaware the resident also received food orally. Resident No. 19 lost weight since her admission in August 2000, to North Okaloosa. However, the trend was noted by the facility when it became significant. The concern was addressed and the weight stabilized after June 2001. The resident remained in her ideal body weight range, so there was no need to recapture the lost weight. In July, a physician review noted that the resident was "well-nourished." The surveyor acknowledged that there had been no significant weight loss from March to September 2001, and that weights were stable from June until the survey. In September, the resident’s psychiatrist noted that there had previously been a weight loss concern but that it had been resolved. The weight loss had occurred due to his medical condition and his need for 15 different medications which affected his appetite and condition. Resident No. 25 had a diagnosis of failure to thrive and was placed on Hospice care. Failure to thrive means an accumulation of factors trending to weight loss. Eating more does not affect weight loss as there is an inability to utilize nutrients. AHCA's surveyor objected to the fact that there was a dietary recommendation on October 23, 2001, for double portions, which had not resulted in an order. A physician’s order is required to make a diet change, and there is no indication of failure to notify the physician. However, the resident already received 3,300 calories, far in excess of her assessed needs, consumed 100 percent of her meals, and continued to lose weight. From a dietary standpoint, there was no reason to believe the addition of more calories would have affected the trend caused by her failure to thrive. The evidence did not demonstrate any Class II deficiencies related to these residents under Tag F-325.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, there was no basis upon which AHCA could have issued Conditional ratings to North Okaloosa on July 12, 2001, or November 29, 2001 or impose a fine. It is RECOMMENDED that the Agency for Health Care Administration enter a final order revising the July 12, 2001, and November 29, 2001, survey reports by deleting the deficiencies described under Tags F-157, F-221, F-279, F-324, and F-325, and issuing Standard ratings to North Okaloosa to replace the previously issued Conditional ratings, and correcting all other records to reflect the absence of any proven deficiencies at North Okaloosa during either survey, and dismiss the Administrative Complaint. DONE AND ENTERED this 3rd day of April, 2003, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of April, 2003. COPIES FURNISHED: Jodi C. Page, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308 Donna H. Stinson, Esquire Broad & Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 R. Davis Thomas, Esquire Broad & Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302
