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 This case concerns an administrative complaint brought by the Petitioner against the Respondent alleging various violations of Chapter 458, Florida Statutes. Generally speaking, the Respondent is accused of prescribing controlled substances in bad faith, deception, untrue and fraudulent representations in the practice of medicine failing to keep written medical records justifying treatment gross or repeated malpractice or the failure to practice medicine with the requisite level of care, skill and treatment expected of him and with the violation of a related provision of law, premised upon the aforementioned substantive violations.
Findings Of Fact The Board accepts and adopts and incorporates herein the Findings of Fact of the Hearing Officer. There is competent substantial evidence to support the Findings of Fact.
The Issue Whether Shady Rest Care Pavilion, Inc. failed to maintain the nutritional status of one of its residents so as to justify the imposition of a conditional license rating upon the facility and an administrative fine of $2,500.
Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings are made: Shady Rest is licensed by the Agency as a skilled nursing facility. Shady Rest's license number is SNF1497096. The Agency conducted an on-site survey of Shady Rest from July 30, 2001, to August 2, 2001. At the time of the survey, Shady Rest's licensure status was standard. The survey was conducted by a "team" that included dietitian Lori Riddle and other health care professionals. The survey team identified several deficiencies at the facility. The deficiencies were detailed on the Form 2567 which was provided to Shady Rest by the Agency. The only deficiency still at issue in this proceeding is the Tag F325 which was summarized on the Form 2567 as follows: Based on observations, clinical record review and staff interviews, the facility failed to ensure that nutritional needs were met for 3 (Residents 11, 21 and 22) of 5 active sampled residents receiving tube feeding who were at high risk for malnutrition as evidenced by significant weight loss, low albumin and total protein levels and recurring pressure sores. The survey team classified the Tag F325 at Level "G" (i.e., isolated actual harm) on the federal scope and severity matrix, which corresponds to an isolated Class II deficiency under the Florida classification scheme. Based upon the cited Class II deficiency, the Agency issued a notice of intent to change Shady Rest's licensure status from standard to conditional, and the Agency initiated a separate action to impose an administrative fine upon Shady Rest. This proceeding followed. At the hearing, the Agency narrowed the focus of the alleged deficiency from the three residents identified on the Form 2567 to only one, Resident 11. No evidence or testimony was presented regarding any other residents. Resident 11 is a female. At the time of the survey, she was 89 years old, 64 inches (five feet, four inches) tall, and weighed 145 pounds. She has been at Shady Rest since 1987. A care plan for Resident 11 was developed by a "team" that included the director of nursing at Shady Rest, a nurse (Sonja Reece, R.N.), a dietitian (Ann Marie Shields, R.D.), two care plan coordinators, and social service and activity personnel. Members of the care plan team worked closely with Resident 11's physician, Dr. Lakshmi Bushan, to manage Resident 11's medical conditions. Dr. Bushan was actively involved with the care of Resident 11 and was very familiar with her conditions. Dr. Bushan was at the facility on a weekly basis and sometimes several times per week. Resident 11 is totally dependent on Shady Rest and its staff for the provision of nutrition. She is fed through a tube connected directly to her stomach. Resident 11 is a "very complex resident" as a result of a myriad of serious medical conditions, including heart attack, seizure disorder, edema (i.e., swelling of the tissues due to fluid retention), hiatal hernia with reflux, pemphagus (i.e., an autoimmune disease resulting in blisters around the body), congestion in the lungs which caused breathing problems, kidney disease, and liver problems. She was also prone to skin breakdown. The treatment of Resident 11 was complicated by the fact that management of one of her conditions would exacerbate another. For example, the Prednisone she was taking to treat her pemphagus increased her fluid retention and, hence, her edema; but, Lasix, the diuretic she was taking for the edema, caused her to have diarrhea which led to the breakdown of her skin from constant cleaning and put her at risk of dehydration and kidney failure. Resident 11's edema was at a dangerous level, referred to as "3+ pitting edema." Relieving the edema was determined to be of critical importance to Resident 11 by her physician. The fluid retention in Resident 11's lungs caused her to suffer from shortness of breath which could ultimately lead to congestive heart failure. Because Resident 11 did not respond well to Lasix and because it actually exacerbated her other medical problems (i.e., skin breakdown), a fluid reduction diet was deemed necessary by her physician. Resident 11 was overweight, partially due to her edema. Resident 11's weight contributed to and exacerbated her medical conditions, particularly her congestion and breathing problems, and it enhanced her risk of congestive heart failure. On April 3, 2001, Dr. Bushan ordered an evaluation of Resident 11's nutritional status and the adequacy of her tube feeding. Resident 11 weighed 163 pounds on that date. On April 4, 2001, Ms. Shields, performed the evaluation ordered by Dr. Bushan. Ms. Shields calculated the total calories per day (cal/day) needed by Resident 11 based upon a standard formula. She then subtracted 400 cal/day to take into account the weight loss desired by Dr. Bushan. Ms. Shields' calculation resulted in an estimated caloric need for Resident 11 of 1,100 to 1,200 cal/day. Because the feeding ordered at that time provided 1,125 cal/day, which was within the range computed by Ms. Shields, no changes were made to Resident 11's diet at that time. Resident 11 was, however, taken off Lasix at that time because it was not contributing significantly to her weight loss and it was putting her at risk for dehydration and kidney failure. Resident 11's weight dropped only slightly after the April 4, 2001, evaluation. On May 1, 2001, she weighed 159 pounds and on June 1, 2001, she weighed 158 pounds. Dr. Bushan wanted Resident 11 to lose more weight more rapidly to stabilize her serious medical conditions. Accordingly, on June 13, 2001, Dr. Bushan requested a dietary consultant to check the amount of Resident 11's tube feedings in order to implement a planned weight loss program to reduce Resident 11's weight to 145 to 150 pounds. Ms. Shields conducted the assessment on June 14, 2001, and after consulting with Resident 11's care plan team, she recommended to Dr. Bushan that Resident 11's caloric intake be reduced from 1,125 cal/day to 750 cal/day to accomplish the rapid and significant weight loss desired by Dr. Bushan. Dr. Bushan accepted Ms. Shield's recommendations and ordered the reduction in calories on June 14, 2001. On that date, Resident 11 weighed 158 pounds. Resident 11's care plan was updated on June 14, 2001, to reflect the goal of reducing her weight by not more than five pounds per week until she reached less than or equal to 150 pounds. The dietary change achieved the desired effect of rapidly reducing Resident 11's weight and stabilizing her medical conditions. Her weight records showed the following: Date June 20, 2001 Weight 153 June 27, 2001 153 July 4, 2001 152 July 11, 2001 153 July 18, 2001 152 July 25, 2001 n/a August 2, 2001 145 The dietary notes for August 1, 2001, indicate that Resident 11's "weight goal was met" and recommended a dietary change to increase Resident 11's caloric intake to 1,000 cal/day. The record does not include the doctor's order implementing that recommendation. However, by August 8, 2001, Resident 11's weight was at 151 pounds, suggesting that the dietary change was implemented. Between the June 14, 2001, dietary change and the August 2, 2001, survey, Resident 11 lost 13 pounds, which is an 8.2 percent weight loss. For the three-month period of May 1, 2001 through August 2, 2001, Resident 11 lost 14 pounds, which is an 8.8 percent weight loss. Resident 11's edema improved significantly during this period; it was no longer at the "3+ pitting edema" level. In this regard, some of Resident 11's weight loss is attributable to the elimination of retained fluids (i.e., reduction in her edema), which was a significant purpose of the weight loss program. The amount of the weight loss attributable to the fluid loss is not quantifiable. The federal guidelines discussing Tag F325, which the Agency's survey team uses in its evaluation of a facility, state that "weight loss (or gain) is a guide in determining nutritional status" and identify parameters to be used in evaluating the significance or severity of weight loss. The 8.8 percent weight loss experienced by Resident 11 over a three- month period would be considered "severe" based upon the parameters. The parameters in the federal guidelines specifically refer to "unplanned and undesired weight loss." By contrast, the weight loss experienced by Resident 11 was planned and desirable. It was directed by Dr. Bushan after Ms. Shield's dietary consultation in order to reduce Resident 11's fluid intake and her edema while also promoting rapid weight loss to minimize her congestion and related breathing problems. The estimated protein needs for Resident 11 were 53 to 57 grams per day. The protein that she was being given, both prior to and after the June 14, 2001, dietary change was within that range. Increasing Resident 11's protein to offset the calorie reduction was not considered a viable option for Resident 11 because her history showed that the more protein she received the more weight she gained. Moreover, too much protein could cause liver failure, which was a risk for Resident 11. When the body is not receiving enough calories, it can metabolize protein as a calorie source rather than for the purposes protein is normally used, such as health of the skin. Resident 11 experienced skin breakdown (i.e., pressure sores or decubitus ulcers) after the June 14, 2001, dietary change. The sores were very small in size and, consistent with Resident 11's past history, the sores healed quickly. Therefore, they are not indicative of a protein deficiency. Indeed, subsequent to the dietary change, Resident 11's skin turgor was good. The laboratory reports for Resident 11 showed her having low albumin levels after the dietary change. Low albumin is generally an indicator of insufficient protein in the body. However, as noted above, the rate at which Resident 11's skin healed suggests that she was getting sufficient protein. Resident 11's low albumin level, in and of itself, is not determinative of her nutritional status. Indeed, the federal guidelines provided to the survey team state: Because some healthy elderly people have abnormal laboratory values, and because abnormal values can be expected in some disease processes, do not expect laboratory values to be within normal ranges for all residents. Consider abnormal values in conjunction with the resident's clinical condition and baseline abnormal values. Even before the June 14, 2001, dietary change, Resident 11's albumin level was not within the normal range. Her abnormal albumin levels may have been the result of her liver problems. Dr. Bushan and the care plan team at Shady Rest managed Resident 11's care based upon their clinical observations of her in conjunction with their experience regarding what worked for her in the past, not simply based upon her laboratory values. They were constantly weighing standards of practice with what was actually happening with Resident 11.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration issue a final order which: Dismisses the Administrative Complaint against Shady Rest Care Pavilion in DOAH Case No. 02-1291; and Rescinds the notice of intent to assign conditional licensure status to Shady Rest Care Pavilion in DOAH Case No. 02-1965 and retains the facility's standard licensure status. DONE AND ENTERED this 26th day of August, 2002, in Tallahassee, Leon County, Florida. T. KENT WETHERELL, II Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 2002.
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
