The Issue The issues are whether, contrary to section 409.913, Florida Statutes, and Florida Administrative Code Rule 59G-9.070, Respondent has committed violations in core- competency training for nine employees (Eula Brown, Natasia Bernard, Lorine Smiley-Lewin, Taneish Mayers, Irene Thompson, Therese Etienne, Adrae McCalla, Marline Ford, and Cynthia Phinn), "medication administration/validation training" for seven employees (Ms. Bernard, Ms. Smiley-Lewin, Ms. Mayers, Ms. Thompson, Ms. Etienne, Ms. Ford, and Ms. Phinn), service authorizations for two consumers (J. B. and L. H.), and Level 2 background screening and HIPAA training for one employee (Ms. Ford). If Respondent is guilty of any of these violations, an additional issue is the fine that should be imposed.
Findings Of Fact At all material times, Respondent owned half of the shares of Glory House USA, Inc., which, for ten years has operated one or more group homes for the developmentally disabled. At all material times, Respondent has been a Medicaid provider of services under the Florida developmental disabilities waiver program. For 2011, Respondent received $790,367.16 in Medicaid reimbursements for services provided to Medicaid consumers. At all relevant times, Respondent has been subject to a Medicaid Provider Agreement. In this agreement, Respondent agreed to comply with all federal, state, and local laws, including rules, regulations, and statements of policy applicable to the Medicaid program. In particular, Respondent agreed to comply with Petitioner's Medicaid handbooks. On September 29, 2011, Petitioner's inspectors conducted an unannounced inspection of Glory House. During the course of the inspection, Petitioner's inspectors spoke to Respondent's home manager, who answered the inspectors' questions, supplied all of the requested documents that were readily available, and took the inspectors on a tour of the facility. The Medicaid Developmental Disabilities Waiver Services Coverage and Limitations Handbook issued by Petitioner, effective May 2010 (Medicaid Handbook) Appendix A identifies the assurances required by Petitioner and the Agency for Persons with Disabilities (APD) of providers of services under the Developmental Disabilities Home and Community-Based Services Waiver. Appendix A Section 2.1 imposes specific training requirements on providers and their employees. Appendix A Section 2.1.G imposes the requirement of core competency training upon "[a]ll direct service providers . . . within 90 days of employment." As of the date of the inspection, seven employees, who had been employed by Respondent's corporation for over 90 days, had not completed direct-care core competency training: Ms. Brown, Ms. Bernard, Ms. Smiley-Levin, Ms. Mayers, Ms. Thompson, Ms. Etienne, and Ms. Phinn. Petitioner has thus proved seven of the nine alleged violations of this training requirement. Respondent's corporation employed Ms. Ford in July 2011, so she was still in her first 90 days of employment at the time of the inspection and was not yet required to have completed her core competency training. Petitioner seems to have relied on an earlier date shown in Petitioner Exhibit 3, but this date purports to show the date of the employee's application, not the date of hire. The only evidence of Ms. Ford's hire date is the testimony of Respondent's daughter, who is the assistant administrator, and she places the date of hire in July 2011. Ms. McCalla had completed the required training prior to the site inspection. Certificates documenting this training show that Ms. McCalla completed the APD Core Competency Training I on September 14, 2006, and APD Core Competency Training II on September 19, 2006. For the two reasons noted in the Conclusions of Law, it is irrelevant that Respondent may not have provided the certificate to the inspectors at the time of the inspection, so the Administrative Law Judge declines to make a finding of fact on whether Respondent provided these certificates to Petitioner at the time of the inspection or within the 15 additional days allowed by the inspector for the provision of documents, as noted below. On the other hand, Respondent's argument that core competency training was only required of employees providing unsupervised direct care to consumers is unsupported by the above-cited provision of the Medicaid Handbook. The allegation as to "medication administration/validation training" is a composite allegation. As noted in the Conclusions of Law, certain employees of providers must undergo medication administration training and validation; these are separate requirements. Also, there is no requirement of "validation training," as suggested by Petitioner's allegation. As of the date of the inspection, six of the seven named employees had completed medication administration training. Ms. Ford was the only employee who had not completed medication administration training, but she did not, at the time, administer medication to consumers or supervise their self-administration of medication. As explained in the Conclusions of Law, the Administrative Law Judge has rejected Petitioner's claim that Respondent had to affirmatively designate those employees who were not allowed to administer medications or supervise the self-administration of medications, so the Administrative Law Judge declines to make a finding of fact on whether Respondent so designated any such employees. Petitioner has thus failed to prove any of the seven alleged violations of this training requirement. As of the date of the inspection, three of the seven named employees had current validations for medication administration: Ms. Mayers, Ms. Etienne, and Ms. Phinn. (Like Ms. Ford, though, Ms. Etienne did not, at the time, administer medication to consumers or supervise their self-administration of medication, so Petitioner's proof as to Ms. Etienne fails on two grounds.) Because, as noted above, Ms. Ford was not designated to administered medications or supervise the self- administration of medications, Petitioner has thus proved three of the seven alleged violations of the validation requirement: Ms. Bernard, Ms. Smiley-Lewin, and Ms. Thompson lacked the required validations. As of the date of the inspection, one employee--the peripatetic Ms. Ford--had not completed HIPAA training. However, the record fails to establish the specific details of this requirement. In its proposed recommended order, Petitioner has relied on two documents: the Non-Institutional Medicaid Provider Agreement (Petitioner Exhibit 1, p. 16), which states only: "The provider agrees to comply with local, state, and federal laws, as well as rules, regulations, and statement of policy applicable to the Medicaid program, including the Medicaid . . . Handbooks . . . "; and the Medicaid Handbook, which states: Florida Medicaid has implemented all of the requirements contained in . . . HIPAA. [A]ll Medicaid providers, including their staff . . ., must comply with HIPAA privacy requirements. Providers who meet the definition of a covered entity according to HIPAA must comply with HIPAA Electronic Data Interchange (EDI) requirements. . . . For the reason noted in the Conclusions of Law, Petitioner has failed to prove its alleged HIPAA-training violation. As of the date of the inspection, Ms. Ford had submitted unspecified documentation sufficient to allow the Department of Children and Family Services (DCF) to issue a letter, dated June 29, 2011, documenting "the final results of a criminal history records check received by [DCF], required by Florida Statute for the below stated program," which is noted as an "APD Foster/Group Home." The letter further states: "[DCF] received the complete criminal history records for [Ms. Ford]. Nothing was found in the Department's review that disqualifies the individual from serving in the program . . . for which this screening was requested and is required by law." The letter adds that "[t]his screening remains valid for five years providing the applicant does not have a 90 day break in service " The Medicaid Handbook, at page 55, states: Direct service provider applicants must comply with the requirements of a level 2 screening in accordance with section 435.04, F.S. Compliance with this requirement may be accomplished through one of two ways: ?Background screening pursuant to s. 393.0655, F.S., or Applicants must submit a fingerprinting card, an affidavit of good moral character, a caretaker information sheet, and a check . . . to DCF for processing. . . . The results of this screening will be submitted with the Medicaid enrollment application. ?Background screenings pursuant to section 409.907, F.S. Applicants must submit a fingerprint card with the Medicaid Enrollment Application and a check made payable to the Medicaid fiscal agent for processing; or, if available, the applicant may submit the screening through an approved live scan location. Screening is performed at the time of enrollment and every five years thereafter. It is the responsibility of the applicant or provider to ensure this request for screening or rescreening is submitted for processing in a timely manner. Assuming that the cited provisions impose any duty upon Respondent beside ensuring that the employee or prospective employee timely submits her request for screening or rescreening, it is difficult to understand how Ms. Ford's screening document fails to satisfy the second alternative in the first bulleted paragraph. It certainly appears that Ms. Ford submitted the required items to DCF for processing, and DCF found nothing to prevent her employment at Glory House. Further confirming its responsiveness to the screening requirement in the Medicaid Handbook, the DCF letter even notes that it is good for five years. Petitioner has thus failed to prove its alleged screening violation. Medicaid Handbook Appendix A Section 3.6.E states that a provider may "[b]ill for only those services for which an approved service authorization has been received. Copies of service authorizations shall be kept on file by the provider and shall be made available to APD, [Petitioner], or their authorized representatives for monitoring purposes." As of the date of the inspection, L. H. and J. B. had current service authorizations. The terms of these authorizations were July 1, 2011, through June 30, 2012. Petitioner has thus failed to prove the two service authorization violations. By letter hand delivered to the home manager on September 29, 2011, Petitioner provided Respondent with an additional 15 days to provide, among other things, all employee records, including level 2 background screens. The letter is not free from ambiguity, largely because it is a form for use in a Medicaid-overpayment case that, in this case, covers a list of items that Respondent needed to provide Petitioner following the inspection. In any event, the letter cannot be interpreted as extending the time for compliance with the underlying requirements. In other words, if an employee obtained a medical administration validation on October 5, 2011, it would not obviate the violation. As the Administrative Law Judge noted at the hearing, such an interpretation of the letter would enable providers to ignore many Medicaid program requirements until Petitioner conducted an inspection and then avoid any sanctions by belatedly coming into compliance--after the inspection uncovered violations. There is no indication of prior offenses by Respondent under the Medicaid program. Thus, as defined in the rule discussed in the Conclusions of Law, the ten proved violations all are a first offense for the purpose of identifying the proper fine per violation.
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of seven violations of the core competency training requirement and three violations of the medication administration validation requirement and imposing a fine of $10,000. DONE AND ENTERED this 12th day of July, 2012, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 2012. COPIES FURNISHED: Jeffries H. Duvall, Esquire Agency for Health Care Administration Fort Knox Building 3, Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308 jeffries.duvall@ahca.myflorida.com Randy A. Fleischer, Esquire Randy A. Fleischer, P.A. 8258 State Road 84 Davie, Florida 33324 randy@igc.org Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Stuart Williams, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Elizabeth Dudek, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1 Tallahassee, Florida 32308
The Issue The issue is whether Petitioner may impose a conditional licensure rating on Respondent's nursing home, pursuant to Section 400.23(7)(b), Florida Statutes, due to the mistaken administration of five medications intended for another resident.
Findings Of Fact Respondent operates a nursing home at 5860 West Jr. College Road, Key West. Petitioner licenses Respondent under Chapter 400, Part II, Florida Statutes, and Chapter 59A-4, Florida Administrative Code. Resident 1 has been a resident of Respondent's facility since May 1999. At the time of the subject incident, Resident 1 was 81 years old and suffered from congestive heart failure, diabetes, emphysema, gastro esophageal reflux disease, anemia, peripheral vascular disease, mild renal disease, and chronic coronary artery disease. On August 12, 2001, at about 5:15 p.m., a nurse was preparing to administer five prescribed medications to Resident 1's roommate. Interrupted by a screaming resident in another room, the nurse secured the already-poured medications and left Resident 1's room to attend to the other resident. Returning to Resident 1's room, the nurse mistakenly administered the already-poured medications to Resident 1, instead of her roommate. As soon as she performed her post-medication review, the nurse realized that she had given Resident 1 the medications intended for Resident 1's roommate. The nurse immediately called her supervisor and a nurse practitioner and informed them of the mistaken administration of medications. The nurse administered five medications to Resident 1. The medications and dosages were Norvasc (7.5 mg), Lopressor (100 mg), Clonadine (0.2 mg), Atacand (16 mg), and Glyburide (5 mg). The only one of these medications prescribed for Resident 1 was Norvasc, but Resident 1's prescription was for only 2.5 mg of Norvasc. Petitioner does not contend that the mistaken administration of Glyburide could have caused any harm or discomfort to Resident 1. This case focuses on the mistaken administration of the other four medications, which are all antihypertensive drugs. Norvasc is a calcium channel blocker. The typical patient will begin to respond to Norvasc in two to three hours. Norvasc reaches its peak effect in the typical patient in six to 12 hours. The half life of Norvasc is 30-50 hours. Lopressor is a beta blocker. Initial and peak effects vary considerably from patient to patient, but Lopressor is absorbed in about one hour and achieves a significant reduction in systolic pressure in about 12 hours. The half life of Lopressor is three to seven hours. Atacand is an angiotensin-II receptor antagonist. The typical patient will begin to respond to Atacand in three to four hours. Atacand reaches its peak effect in the typical patient in a couple of weeks. The half life of Atacand is nine hours. Clonadine is a central-acting antihypertensive. The typical patient will begin to respond to Clonadine in 30-60 minutes, although an older patient may take longer to absorb the drug. Clonadine reaches its peak effect in the typical patient in two to five hours. The half life of Clonadine is 6-24 hours. When told what had happened by the nurse who had administered the wrong medications, the nurse practitioner directed her to send Resident 1 to the hospital for monitoring and evaluation. The hospital is located on the same grounds as Respondent's facility. When informed that she was to be taken to the hospital, Resident 1 asked if she could first eat dinner. Sometime between ten and 30 minutes after the mistaken administration of the medications, Resident 1's blood pressure was 89/56. Earlier the same day, Resident 1's blood pressure had been 109/52, but the prior day it had been 96/53. About one hour after the mistaken administration of the medications, while Resident 1 was being admitted to the hospital, her blood pressure was 84/46. The other important objective finding at the admission of Resident 1 was anemia. Although chronically anemic, Resident 1's blood chemistry reflected atypically low values in hemoglobin and hematocrit. Her red blood cell count was also low. By the time she arrived at the hospital, Resident 1 was experiencing light-headedness, dizziness, dry mouth, and an unsteady gait. The light-headedness and dizziness were likely due to a combination of diabetes, cerebral vascular disease, and anemia. The unsteady gait, as well as nausea and vomiting, which developed after admission, were also not unusual for Resident 1. The only of these conditions likely attributable to the mistakenly administered medications was dry mouth, which was likely due to the Clonadine. In general, Resident 1 did not report any feeling of distress or discomfort. Her only unusual complaint was persistent fatigue, which was probably due to the anemia and clearly, due to its persistence, not due to the mistaken administration of medications a few hours earlier. Hospital staff removed a couple of nitroglycerin patches from Resident 1's chest. Petitioner contends that these two patches necessarily doubled Resident 1's prescribed dose, but Petitioner has not precluded the possibility that each patch contained one-half of the prescribed dose. The emergency room physician ordered the administration of intravenous saline solution. The purpose of this procedure was to increase the circulating volume of blood and, thus, the blood pressure. By 8:15 p.m., the physician ordered the administration of dopamine, which, by hospital rule, required that Resident 1 be placed in the intensive care unit. Administered in an abundance of caution, dopamine would help raise Resident 1's blood pressure, which, according to her personal physician, was not significantly below her normal range. Resident 1 received a low dose of dopamine for 12-16 hours. About 24 hours after the discontinuation of the dopamine, Resident 1's blood pressure had returned to normal, so that her physician ordered the resumption of her normal antihyptertensive medication. While hospitalized, Resident 1 also received a blood transfusion. Although also useful in raising blood pressure, the transfusion was also needed to alleviate the anemia, which was due to gastrointestinal bleeding of recent onset. The anemia cleared up after Resident 1 received medications to treat the bleeding. The Norvasc, Atacand, and Lopressor did not affect Resident 1's blood pressure. Before these medications could have had a significant effect on Resident 1's blood pressure, hospital staff had instituted procedures to maintain proper blood pressure. The Clonadine may have begun to take effect prior to the initiation of the saline solution. However, it is impossible to differentiate the extent, if any, to which Resident 1's blood pressure may have dropped due to the Clonadine, given her history of a range of blood pressures that include fairly low values and the fast-developing anemia due to the recent onset of gastrointestinal bleeding. Except for dry mouth, there is no evidence of any change in Resident 1's physical condition attributable to the mistaken administration of the medications. More importantly, there is no evidence of any loss of physical, mental, or psychosocial well-being due to the mistaken administration of the medications. No organ system suffered any adverse affect from the incident. Even the hospitalization itself and the puncture required for the administration of intravenous medications were unavoidable; given the fast-developing bleeding problem, Resident 1 would have required hospitalization in the next 12-48 hours. At all times, Resident 1 displayed no discomfort or pain and behaved quite normally.
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order eliminating the conditional rating that it had imposed on Respondent's nursing home license because of the medication error that is the subject of this case. DONE AND ENTERED this 15th day of May, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2002. COPIES FURNISHED: Virginia A. Daire, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Nelson Rodney Assistant General Counsel Agency for Health Care Administration 8355 Northwest 53rd Street Miami, Florida 33166 Karen L. Goldsmith Alex Finch Goldsmith, Grout & Lewis, P.A. Post Office Box 2011 Winter Park, Florida 32790
Findings Of Fact The Respondent, Solomon D. Klotz, M.D., at all times pertinent hereto, has held a current, valid medical license number ME 0002269, issued by the Board of Medical Examiners, Department of Professional Regulation, which is the agency charged with enforcing Chapter 458, the "Medical Practice Act," as it relates to qualification for licensure and standards for regulating medical practice of physicians licensed in the State of Florida. The Respondent is also board- certified by the American Board of Internal Medicine in internal medicine and is board- certified in the field of allergy and immunology by the American Board of Allergy and Immunology. The Respondent obtained his M.D. Degree from New York Medical College in 1937, obtaining a Masters from that institution in 1942. He was licensed in New York in 1938 and was made a diplomate of the National Board of Medical Examiners in 1938. He was issued his Florida license in 1941. He served in the Medical Corps of the United States Army in World War II and during the years 1945 and 1946 was a clinical instructor at New York Medical College, and a research fellow at Metropolitan Hospital Research Unit in New York. The Respondent has practiced in his specialty field of internal medicine as well as allergy and immunology in Florida for many years. He is presently a clinical professor at the College of Health of the University of Central Florida, and an adjunct professor at the Department of Biological Sciences at the University of Central Florida. Respondent is presently on the medical staffs at Winter Park Memorial Hospital, Florida Hospital, Orlando Regional Medical Center and Humana Hospital/Lucerne, with a senior consultant rating at each of the above hospitals. The Respondent is a member of 21 professional societies and was a founding member of the Salk Institute for Biological Studies and, the board of the Joint Council of Allergy and Immunology. He has served as president of the American College of Allergists, the Florida Allergy Society, Southeastern Allergy Society, and is president of the medical staff of Florida Hospital in Orlando. The Respondent has published or presented more than 50 research papers, seven of which have been published within the past three years in such journals as the Annals of Allergy, the Journal of the Florida Medical Association, the Journal of the American Academy of Allergy and Immunology and the American Heart Journal. Concerning the disease or condition most pertinent to the charges in the administrative complaint, the Respondent published a paper jointly with Dr. Von Hilsheimer in 1970 concerning minimal brain dysfunction, attention disorders and the diagnosis of functional narcolepsy. Dr. George Von Hilsheimer was accepted as Respondent's expert witness concerning the diagnosis of narcolepsy and the various forms or manifestations of narcolepsy and the treatment thereof. He is a licensed psychologist in the State of Florida, having been educated at the University of Miami with postgraduate work at the University of Chicago. He interned in psychology at the Corsack Clinic and the Seabrook Institute in San Francisco. He completed his Ph.D. in psychology with a multiple major in neuropsychology, psychoimmunology and psychotherapy. He is an associate fellow in the Society for Clinical Ecology, a consultant to the Science Advisory Committee of the Environmental Protection Agency as a neuropsychologist and behavioral toxochologist. He is eligible for board certification by the Academy for Psychosomatic Medicine and the American Academy of Behavioral Medicine. He has published numerous reference papers and a number of books, one of which books focused on the diagnosis of minimal brain dysfunction and the issue of psychosomatic versus somatic causes for behavior. He has presented two papers in conjunction with the Respondent on the issue of minimal brain dysfunction, tension disorders and the diagnosis of functional narcolepsy. Since 1980, Dr. Von Hilsheimer's practice has been split between psychotherapy and psychoimmunology. In the past ten years he has presented numerous continuing education workshops for physicians, which courses were certified by the American Medical Association. Dr. Dale K. Lindberg, M.D., was accepted as an expert witness for the Petitioner regarding the pharmacological effects, uses and indications of the drugs related to the charges in the administrative complaint. Dr. Lindberg has been a licensed physician in the State of Florida since 1959. He is board certified in nuclear medicine. He took a residency in nuclear medicine at Mt. Sinai Hospital in Miami Beach between the years 1974 and 1977. Since 1973, his practice has been limited to primarily that of supervising methadone maintenance programs and clinics. Prior to 1973 his practice was in the area of family practice, as well as nuclear medicine. He is a member of the Broward County Medical Association, Florida Medical Association, American Medical Association, Broward County Family Practice Association, as well as the Society of Nuclear Medicine. Dr. Lindberg has never treated a patient with narcolepsy nor has he seen patients exhibiting the various kinds of narcoleptic behavior. METHAQUALONE PRESCRIPTIONS; COUNTS I, II AND III The first three counts in the administrative complaint concern prescriptions written June 24, 1982, for allegedly excessive and unjustified amounts of a controlled substance, methaqualone, prescribed to patients Harri Klotz (Count I) , Sam Meiner (Count II) and Charles Meiner (Count III). Those prescriptions consisted of 121 sopor (150 mgs) for Harri Klotz; 189 parest for Sam Meiner; and 34 quaaludes for Charles Meiner, all of which are methaqualone medications. The Respondent received a telephone call on or shortly before June 24, 1982, the date the prescriptions were written, from a pharmacist whom he regularly dealt with, who informed him that, inasmuch as, effective July 1, 1982, he would be unable to fill methaqualone prescriptions due to a change in the law by which it became a Schedule I drug, that he would make available the small quantity of methaqualone remaining in stock to the Respondent for his patients who required the drug. The Respondent acknowledged having a few such patients and accordingly wrote prescriptions for the above odd numbers of capsules to patients whom had been regularly receiving methaqualone medication for a period of time previously. Patient Harri Klotz is the Respondent's wife. She has been a patient of Respondent since approximately 1940. She suffers from generalized osteo- arthritis involving mainly the hips, which was first diagnosed in 1967. Due to progressive severity of the disease she received surgery in October, 1970, in Germany, for replacement of both hip joints with artificial prosthesis. Since that time the right hip prosthesis joint cracked, causing her severe, chronic pain which caused her great difficulty in sleeping. After taking numerous combinations of medicine, Mrs. Klotz was found to respond most effectively to methaqualone, which induced sleep in spite of the pain, without undesirable side effects the next morning. She ultimately had the right hip prosthesis repaired. Her medical records indicate that this medication had also been prescribed for her by her treating physicians when the prosthetic devices were implanted. In 1981 she again began experiencing the same type of agonizing, chronic pain in her left hip and consulted an orthopedic surgeon at regular intervals concerning it. It was not until November, 1952, however, that the diagnosis was made that her left prosthesis had also broken. During the various attempts to diagnose the cause of this problem with her left hip, she was experiencing severe, chronic pain. Finally, after a third stint of surgery the left hip prosthesis was replaced and her symptoms ultimately improved. In the meantime however, on October 14, 1981, Respondent purchased 1,000 quaaludes for his wife. He did not dispense the entire lot to her, rather she was given 30 capsules at a time for use in inducing sleep during the period when she suffered from her painful condition at intervals of one and one-half to two months. The Respondent carefully monitored her dosage and kept the balance under lock and key at his office, duly recording on a dispensing record the capsules actually given to his wife on each occasion. On June 24, 1982, before methaqualone became a Schedule I Controlled Substance, he last prescribed that substance for his wife when he wrote the prescription for 121 sopor. He has not since prescribed a methaqualone substance to his wife. On June 24, 1982, the Respondent prescribed methaqualone to Sam Meiner. Mr. Meiner (Respondent's counsel) has been a patient of the Respondent since approximately 1968. Be suffers from a severe, chronic painful condition called regional enteritis, a condition characterized by severe, chronic pain and acute bowel spasms associated with acute exacerbations of the enteritis condition. As a result of this condition he has had two bowel resection surgeries, during the course of which surgeons removed approximately six feet of his small intestine. He has suffered from this disease chronically for approximately 18 years, having his first surgery in 1967 and the second in 1977. "hen the enteritis condition became acutely inflamed after his second surgery, he once again sought Respondent's medical advice. He has been a continuous patient of the Respondent ever since that time, seeing him almost on a weekly basis. Included in the total medical care Respondent has given this patient is a prescription of methaqualone for its beneficial soporific and antispasmodic effects designed to curtail the severity and duration of the bowel spasm incidents. Other physicians, as well as Respondent, in treating this patient have attempted many other combinations of medications before the Respondent and patient determined that methaqualone was the most effective modality. Since being under the Respondent's care with attendant methaqualone medication, the patient has required no hospitalization and has been able to lead a substantially normal existence, even though this disease or condition if unsuccessfully treated can ultimately prove fatal, especially if additional such surgical procedures are resorted to. Witness Meiner was shown to have no abnormal adverse effects nor physical or psychological dependence on the drug. It is now no longer legally obtainable, the patient being afforded his last prescription therefor on June 24, 1982, some six days before the prescription of the drug became illegal. On June 24, 1982, the Respondent prescribed 34 methaqualone capsules to Charles Meiner. Charles Meiner (also counsel for Respondent) suffers from a chronic, severe back injury involving a ruptured or degenerative disc. He periodically suffers excruciating, chronic back pain, resulting in his inability to sleep. He has been a patient of the Respondent since 1969. In 1973 he required hospitalization due to the severity of the back pain. lie has seen the Respondent for this problem at regular intervals ever since. He had been prescribed methaqualone on a number of occasions prior to June, 1982, as the medication helps his insomnia resulting from the chronic back pain, without imposing any adverse effect the following morning or inhibiting his ability to function in the legal profession. Be has never taken more than one tablet per day and some days only a half tablet during the course of his back pain flare- ups. In May of 1982, his back condition became particularly severe, with persistent pain. Because of this exacerbation of his back condition, he was given a prescription for 34 quaalude tablets on June 24, 1982, to relieve his pain and enable him to sleep. During the time Respondent prescribed methaqualone to these three above-named patients, methaqualone was an acceptable medication for relief of the symptoms these patients exhibited. Petitioner's witness Dr. Lindberg acknowledged that the prescribing of methaqualone by the Respondent to these patients on or before July 1, 1982, was for a medically justifiable purpose, and that the dosages involved were within recommended daily dosages for the treatment of the symptoms exhibited by these patients, as depicted in the Physician's Desk Reference (PDR) a work relied on by both parties throughout this proceeding. AMPHETAMINE PRESCIPTIONS: COUNTS IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX. The prescription of amphetamines became restricted as to use by the enactment of Section 458.331(1)(cc) , Florida Statutes, effective August 30, 1980. This restricted the prescription of any drug which is an amphetamine or a sympathomimetic amine drug (a Schedule II drug) except, as pertinent here, for the condition of narcolepsy. Prior to the restriction of the drug, the Respondent had prescribed such drugs for short-term use for patients who were attempting to embark on a successful weight-control program. The Petitioner's expert witness, Dr. Lindberg, acknowledged that this was a medically appropriate use of this type of medication at the time and that he himself had made similar prescriptions for similar purposes. The Respondent conceded that as of July 3, 1980, that he was not aware of the change in the legal status of amphetamine type drugs by the enactment of the above statute, and did not become aware of such restrictions until the pharmacist with whom he regularly dealt informed him that he could not prescribe Biphetamine, Dexedrine or other sympathomimetics unless the patient had a narcoleptic condition. Upon becoming aware of this restriction after August 30,1980, the Respondent discontinued use of those drugs except for the treatment of narcoleptic symptoms in patients. Dr. Lindberg opined that the only type of narcolepsy he would recognize was "ideopathic narcolepsy." By this he meant that he would only diagnose narcolepsy when all four recognized symptoms are present: excessive daytime sleepiness, cataplexy (a condition when muscles become limp) , hypnogogic hallucinations (dreams shortly before going to sleep or upon awakening) and sleep paralysis whereby the patient is unable to move, although the limbs are not rigid. Dr. Lindberg has never treated a patient with narcolepsy nor has he ever observed a patient exhibit narcoleptic behavior in his practice. Both the Respondent and Dr. Von Hilsheimer, the Respondent's expert witness on the subject, have studied and treated this condition and published recognized research papers on the subject of narcolepsy. Further, the Respondent in connection with his speciality in the field of allergies, has performed testing regarding patients with certain food sensitivities and has observed that some of them will exhibit narcoleptic symptoms as a reaction to certain foods. Dr. Von Hilsheimer, as delineated above, has extensive experience in the diagnosis and treatment of narcolepsy in its various forms and in teaching recognition of the condition to doctors through continuing education courses. Idiopathic narcolepsy, the extreme or classic view of the disease, may involve exhibition of all four of the above symptoms in a patient, however, only 10 percent of patients legitimately diagnosed as narcoleptic present all four symptoms, and therefore most of the scientific and medical community uses the term "narcolepsy" In a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. In addition to narcolepsy being a primary affliction, it can also be a subsyndrome, or secondary disorder related to a different medical problem. It can be permanent or can be a transient condition and can be a by-product of unusual psychological or physical stress. The Respondent prescribed a small dosage of an amphetamine for Nina Balabon between January 11, 1980, and September 17, 1982, at various times. (Count IV) Ms. Balabon is a 92 year old woman who has been taking a very small dosage of Dexedrine for many years. The dosage is substantially below that allowable for such a patient as conceded by the Petitioner and delineated in the Physician's Desk Reference. Ms. Balabon lives alone in Woodstock, New York, and is the foster mother of the Respondent's wife. She had been under the care of another physician who prescribed this course of treatment and drug for her so that she could remain alert enough to independently function and take care of herself in her own home. She is home-bound and after her doctor's death, she was unable to secure another doctor who would make house calls. She called upon the Respondent who is, in effect, a family member, and financially supports her, and asked him to prescribe the medication for her, in conjunction with which she retained the services of a visiting nurse. In her old age she has become afflicted with lassitude, inappropriate and excessive daytime sleepiness, depression and a diminished "will to live." The Respondent visits her in Woodstock, New York, periodically and he or his wife, telephone her at least once a week. A visiting nurse checks on her condition weekly and reports to the Respondent on her physical condition. The Petitioner's expert witness, Dr. Lindberg, has never seen this patient, but surmised upon her recorded weight that she is slightly malnourished. Accordingly, he opines that it is inappropriate to give a person with such a condition (slight malnourishment) amphetamines to curb her appetite and provide her "pep." The Respondent, however, did not prescribe amphetamine for this purpose. Be found, in the exercise of his medical judgment that she exhibits definite symptoms of narcolepsy. The dosage is extremely small and the patient is not shown to suffer any adverse effects therefrom. It was not shown that the dosage curbed her appetite, and indeed, Respondent established that the patient is not malnourished. She is a very small, slightly built woman and her mere recorded weight is not an indication in itself of malnourishment such that the prescription involved would be contraindicated. Petitioner's expert witness, further was unaware that the patient exhibited symptoms of narcoleptic behavior, and admitted that otherwise the dosages were quite small and not excessive for such a patient. Dr. Lindberg merely opposed the prescription of the medication because he believed that the law changed regarding the use of this drug, such that after August 30, 1980, it is only permissible for narcoleptic symptoms. In any event, the Respondent's diagnosis of the patient was uncontradicted and the 92 year old patient was shown to benefit from this treatment of her condition because it permitted her, with the assistance of the visiting nurse, to continue living independently rather than suffering commission to a nursing home or other institutional facility. Count VII concerns alleged prescriptions of amphetamines to one Doris Calloway between February 16, 1982 and October 13, 1982. Petitioner failed to introduce any evidence or testimony concerning this count. With regard to Count XI, Respondent prescribed on only one occasion, 50 Biphetamine capsules for Lori Carroccia on September 29, 1980. At the time this prescription was written and issued, the Respondent was unaware of the recent restrictions imposed by the legislature on the purposes for which amphetamine-type drugs could be prescribed by the passage of Section 458.331(1)(cc), Florida Statutes, effective July 1, 1980. The Respondent had known this patient for approximately six years and she was his nurse, employed at his clinic at the time the prescription was written. The single prescription was written when she complained to him of difficulty in starting a weight loss program and asked for his assistance. Prior to writing the prescription, he checked Ms. Carroccia's physical health, checked her weight and blood pressure, and indeed was already aware of her medical history because of his close association with her. During the entire two months she received this medication Respondent saw her on a daily basis and monitored her progress. The medication proved to be an effective means for her to develop a successful weight loss program. She suffered no adverse effects from receiving this drug. The Respondent only prescribed this medication once, in a small dosage to Initiate her weight loss program and not for the purposes of maintaining weight loss or a particular weight level through long-term prescriptions. Petitioner's sole expert witness conceded that the dosages were not excessive and were medically indicated in the PDR for the initiation of such a weight loss program. Petitioner's expert witness admitted that his opinion regarding inappropriateness of the prescription was solely predicated on the change in the legal status of the drug. The Respondent prescribed an amphetamine medication to patient Evelyn Lilly between April 14, 1981 and December 19, 1981 (Count XII). Ms. Lilly had been his patient since 1979 for allergy evaluation and treatment to alleviate chronic symptoms of runny nose, throat infections and irritations and sinus headaches. Respondent gave her an allergic evaluation in response to these symptoms. In completing her patient history he noted that Ms. Lilly suffers from rheumatism and arthritis. During the course of her allergy treatments Ms. Lilly's weight began increasing dramatically, with a worsening of her arthritic condition. Respondent noted she was markedly fatigued and became concerned about her general physical condition. In response to her fatigue or lassitude complaints, he initially performed a thyroid test in an effort to determine the cause of her lassitude and rapid weight gain. That test was inconclusive. lie then decided that between the complications of arthritis and her allergies he must reduce her weight before he could successfully treat either of those conditions. He initially prescribed Tenuate Dosepan which proved ineffective and then Ritalin, which also proved ineffective. She was then prescribed a course of Biphetamine. She responded dramatically to this medication with relief of her lassitude and the loss of 30 to 40 pounds. After noting that the initial sympathomimetic type drugs prescribed were ineffective and that the change to the Biphetamine produced markedly successful results, Respondent came to the conclusion that the patient was narcoleptic. Narcolepsy sometimes is not alleviated with the prescribing of one type of sympathomimetic drug when the switch to treatment with another type will suddenly prove to be successful in alleviating the narcoleptic symptoms. The doctor's chart for this patient did not definitely indicate the purpose of the prescription of the amphetamine medication, although Dr. Klotz candidly responded in his testimony that it may have been in part for weight control because a reduction in weight would help alleviate her arthritic joint problems. However, inasmuch as narcolepsy can be indicated when one type of sympathomimetic drug will not relieve its symptoms and another type will and since is. Lilly in her reaction to the medications displayed this phenomenon, Respondent, in the reasonable exercise of his medical judgment concluded that she displayed symptoms of narcolepsy. This view is corroborated by Dr. Von Hilsheimer. He has had more than 1,000 patients referred to him over the years by the Respondent. Approximately one-third of these patients were obese and yet he was only aware of four such patients who were treated with biphetamines by the Respondent. Be thus concludes that the Respondent used some differential reason other than mere weight control for prescribing biphetamine which led to the diagnosis of symptomatic narcolepsy with Ms. Lilly. The Petitioner's expert witness once again felt that the Biphetamine and Ritalin prescriptions for Ms. Lilly were inappropriate and excessive, but acknowledged that his criticism of these prescriptions was predicated solely on the fact that the medication had become illegal for prescription for weight control purposes before Ms. Lilly's prescriptions were made. Dr. Lindberg ultimately agreed however, after consulting the PDR that the amounts and types of medication were within appropriate indications, dosage limits and amounts and thus the amounts prescribed were within the reasonable exercise of the Respondent's judgment as a physician for the symptoms displayed, and alleviated them. Concerning this patient, as with all the others involved herein, Petitioner's expert witness bases his testimony merely on the doctor's patient chart which does not specifically refer to narcoleptic symptoms. Respondent admits his records are not detailed in all cases, since the patients were not referrals, but were his patients for many years such that he was intimately familiar with their histories and conditions. Based on the lack of reference to narcoleptic symptoms in the records themselves, Dr. Lindberg opined that the prescription was medically inappropriate, however, the mere absence of reference to that condition in the medical records alone does not establish the medical inappropriateness of the prescription, especially in view of the Respondent's showing (corroborated by Dr. Von Hilsheimer) that indeed Ms. Lilly was narcoleptic. Mr. Emmett Peter was prescribed biphetamines between October 16, 1979 and September 14, 1982 by the Respondent (Count XVI). Mr. peter has been Respondent's patient since 1969 and `gas definitely diagnosed as a narcoleptic individual by a physician who treated him prior to that time and related that fact in his initial medical history provided Respondent. At the time he and his wife became patients of the Respondent, Mr. Peter was receiving a medication called Obedrin, which is a dexedrine-type drug. During the entire time he received medication from the Respondent, he periodically visited the Respondent on his own behalf, as well as accompanying his wife to the Respondent's clinic for treatment, at which times the Respondent also observed Mr. Peter. Although the Respondent was unaware of the change in the law regarding restriction of the use of amphetamines to the treatment of narcolepsy at the time he prescribed Mr. Peter's medications at issue in this case, he continued to prescribe the medication for Mr. Peter after he became aware of the law, because he definitely diagnosed Mr. Peter to be a narcoleptic. The Respondent's expert witness, Dr. Von Hilsheimer, has seen both Mr. and Mrs. Peter on a professional basis as a researcher. He had numerous occasions to observe Mr. Peter, approximately twice a week from March, 1980 through May, 1982. Be became quickly aware of the fact that Mr. Peter was narcoleptic due to the fact that Mr. Peter, when waiting for his wife at Dr. Von Hilsheimer's office, often fell asleep in a very dramatic way, sometimes even when Dr. Von Hilsheimer was engaged in conversation with him. It was thus established that Mr. Peter, based upon his medical history and the personal observation of both Dr. Klotz and Dr. Von Hilsheimer, suffers from a minimal brain dysfunction manifested as excessive, inappropriate sleepiness. Dr. Von Hilsheimer further noted that Mr. Peter's condition is also characterized by moderate cataplexy, another symptom of narcolepsy. There is no question that Mr. Peter suffers from narcolepsy, therefore the prescription of amphetamine medications to Mr. Peter was clearly medically appropriate and the Petitioner admitted that the amounts of the medication were not excessive. On February 24, 1981, Charne D. Porter, the Respondent's daughter was given a prescription for 30 10-mg Ritalin tablets (Count XVII). The Respondent has been her treating physician most of her life. At the time the prescription was written she was editing and producing a motion picture. She was working very long hours and complained to Respondent that she was having difficulty staying awake during all times of the day and in completing her film-editing work. Prior to this period of time however, her typical work schedule involved such long hours with no apparent ill effects. This was not an unusual work schedule for her. Dr. Von Hilsheimer has known Ms. Porter since 1979 and she has consulted him professionally in the past. He was quite familiar with the patient history and had occasion to see her during the time the medication involved was prescribed. During this period of time he found that when she was attempting to do film-editing work which is normally a stimulating, arousing type of endeavor, she did not have her normal responsiveness and while talking to him would doze off in the middle of a conversation in his office. The work she was trying to do at the time was quite arousing under unusual conditions of lighting and interest and yet she would still doze off at inappropriate times during the day while working. The doctor did not find that her long work schedule or hours were responsible for such a condition. Ms. Porter had a debilitating illness consisting of the lingering aftereffects of a form of hepatitis and this, coupled with the stress related to her film-editing job (for which she was obtaining treatment through self-hypnosis training by Dr. Von Hilsheimer) caused her to lose her normal "arousal ability." Because of this she did have an attack or episode of transient narcolepsy as diagnosed by Respondent and Dr. Von Hilsheimer. During visits in his office he observed her display three of the four commonly recognized symptoms of narcolepsy during approximately the same period of time in which she received the Ritalin prescription. These inappropriate sleep episodes were a transient condition and Ms. Porter recovered from that condition and is functioning well personally and professionally. The small original Ritalin prescription needed no renewal. The use of the Ritalin prescription was a reasonable exercise of Respondent's medical judgment and approach to alleviating the transitory narcolepsy symptoms exhibited by Ms. Porter and caused her no harm whatever. Patient Sandy Lee Bradford was prescribed Biphetamine between December 14, 1980 and December 15, 1981. She is the daughter of the Respondent's secretary and has been the Respondent's patient for many years. On December 15, 1980, due to her complaint of fatigue, daytime sleepiness episodes, along with inability to lose weight and excessive weight gain, the Respondent first prescribed biphetamines to her. Over a one year period she subsequently received four other prescriptions of biphetamines. Each time she received a new prescription, she personally saw and consulted with Dr. Klotz. At the time the prescriptions were administered she had recently been divorced and was suffering unusual stress and emotional anxiety related to that divorce, which Respondent believed had a direct effect on her sudden weight gain and inability to lose weight. At the time the Respondent made these prescriptions, he was as yet unaware of the change in the legal status of amphetamine-type drugs such that it was no longer legally permissible to prescribe them for weight loss purposes. The Respondent candidly admitted that he primarily prescribed the drugs for assisting her in embarking on a successful weight loss program, not for chronic use. Other anorectic medications had been tried on this patient and had proved ineffective, however, with the judicious prescription and use of the biphetamine medication the patient made substantial progress in losing weight and in alleviating symptoms of fatigue. When Respondent became aware of the change in the legal status of biphetamines, he discontinued that medication promptly and substituted Tenuate Dosepan, which proved ineffective. He then substituted Ionamine which also proved ineffective, in an attempt to avoid prescribing biphetamines for the patient. The biphetamines prescribed were in appropriate, non-excessive quantities for the condition and symptoms exhibited by the patient and successfully alleviated her complaints with no harm to the patient. He discontinued biphetamines because he felt he could not with reasonable medical certainty, diagnose her as a narcoleptic patient. Dr. Lindberg conceded that the prescriptions were medically appropriate, but for the change in the law regarding their permissible use, and that change was the sole basis for his opinion that the prescription was inappropriate. Patient Trudy Heintz was prescribed Dexedrine between January 3, 1980 and October 29, 1982. She has been a patient of the Respondent since the early 1950's. She has displayed, over many years, symptoms of excessive, inappropriate daytime sleepiness and a simple inability to perform her employment duties as a result. The Respondent was treating her for phlebitis and arthritis, and thus she is an internal medicine patient. As such the Respondent monitored her physical condition quite closely, making physical examinations including monitoring of blood pressure when necessary. He observed no adverse effects caused by the administration of Dexedrine to this patient, which alleviated her narcoleptic symptoms and enabled her to remain productive and fully functional in her employment and daily pursuits. The Respondent thus diagnosed her as suffering from narcolepsy and established that as an appropriate basis for the prescription of Dexedrine. He continued to prescribe Dexedrine for the patient, even after he became aware of the restriction of its use because he genuinely believes that she is a true narcoleptic. Dr. Lindberg opined that the Dexedrine was inappropriate medication and was prescribed in excessive amounts. He did not believe that Ms. Heintz exhibited narcoleptic behavior, but he had never observed the patient and based his opinion merely upon less than detailed references to narcoleptic behavior in the patient's records. The Respondent, however, established that this patient had been a patient for many years and he was intimately familiar with the physical condition, complaints and medical history, and makes notes only for his own use. Because of his familiarity with her medical history and problems, it was unnecessary for him to make his own notes in sufficient detail so that Dr. Lindberg would be able to thoroughly review the patient's status and treatment indications by looking at her chart alone. Dr. Lindberg, in opining that the dosage was excessive at 30 mg. per day failed to take into account that the PDR provides that the accepted prescription of Dexedrine for narcolepsy is from 5 mg to 60 mg per day with no time limitation as to its use. His opinion as to excessiveness was based on the medical indications in the PDR for obesity only, not for narcolepsy. Such a dosage for this patient was not excessive in view of her proven diagnosis of narcolepsy. Count XXI concerns the purchase on October 14, 1981, of 1,000 quaalude tablets with regard to which it is alleged that the Respondent failed to maintain proper records justifying purchase and disposal of them as allegedly required by Section 21 USC 1306.04(b). Section 21 USC 1306.04(b) has not been placed in evidence in this proceeding, nor has it been made the subject of judicial notice, pursuant to Section 120.61, Florida Statutes. In any event, the 1,000 quaalude tablets were purchased by the Respondent for use by his wife, Harri Klotz. The Drug Enforcement Administration (DEA) Form 222, required to be maintained by the purchaser of such drugs was maintained by the Respondent and his office manager, and a dispensing record also maintained by them shows that the medication was dispensed upon receipt to Respondent's wife. In fact the drugs were established to be retained in the Respondent's office under lock and key and not physically dispensed to the Respondent's wife at one time, rather they were dedicated to her use, but maintained securely on the Respondent's office premises. Mrs. Klotz was then dispensed 30 tablets at a time in approximately one and one-half to two month intervals, and an additional journal card was established by Ms. Lindblom, the office manager, showing the dates when Mrs. Klotz drew down upon that medication in 30 tablet increments which withdrawals were recorded ads "pills dispensed." Additionally, the 130 methaqualone tablets prescribed for Mrs. Klotz on June 24, 1982, were for the purpose of providing her an additional supply to be used in a light, periodic, controlled manner because the drugs were about to become illegal. Later in August or September, 1982, Ms. Lindblom, when she became aware that the additional prescribing of methaqualone might be illegal, upon advice of Mr. Meiner, the Respondent's counsel, elected to dispose of the remaining quaalude tablets at which time 790 of the original 1,130 tablets dedicated to the use of Mrs. Klotz remained at the Respondent's office and were disposed of. Thus the receipt of 1,000 quaalude tablets was duly recorded in Respondent's record and the 30 tablet dispensations of the medication periodically from October 14, 1981 through June 28, 1982, were recorded in a dispensing record in evidence, which record also reflects the disposal of the 790 unused tablets.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses and the pleadings and arguments of counsel, it is, therefore RECOMMENDED: That the Administrative Complaint against the Respondent, Solomon D. Klotz, be DISMISSED except as to the minor violations of Section 458.331(1)(h) and (cc) Florida Statutes, proven with regards to Counts XI and XVIII for which, under the circumstances of this case, no disciplinary action should be taken. DONE and ENTERED this 4th day of May, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Chief Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Sam C. Meiner, Esquire 26 Wall Street Orlando, Florida 32801 Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether Respondent, Beverly Healthcare Rosemont, was in violation of 42 C.F.R. Section 483, Chapter 400, Florida Statutes, and Rule 59A-4, Florida Administrative Code, at the time of its annual survey from January 22 through 25, 2001, and, if so, whether those violations were uncorrected at the time of the follow-up survey on March 1, 2001, in order to justify the issuance of a Conditional License from March 1, 2001 until April 4, 2001.
Findings Of Fact Respondent is a licensed nursing home in Orlando, Florida. Pursuant to Chapter 400, Florida Statutes, Petitioner surveys Respondent to determine whether it is in compliance with applicable laws and regulations. If there are deficiencies, it determines the level of deficiency. When Petitioner conducts a survey of a nursing home, it issues a survey report, commonly referred to by its form number, a "2567." The particular regulation, and the allegedly deficient practices which constitute a violation of that regulation, are cited in a column on the left side of the paper. After receiving the 2567, the facility is required to develop a plan of correction of the alleged deficiency which is put in the right hand column of the 2567 corresponding to the alleged deficiency. The facility is required to develop this plan of correction regardless of whether it agrees that it is in violation of any regulations, and it is prohibited from being argumentative in the 2567. Petitioner conducted its annual survey of Respondent from January 22 through 25, 2001, and issued a 2567 survey report noting certain deficiencies. The deficiencies are designated as tag numbers. Among those noted were Tag F164, which is the shorthand reference to, and which incorporates C.F.R. Subsection 483.10(e); Tag F332, which refers to and incorporates 42 C.F.R. Subsection 483.25(m)(1); and Tag F465, which refers to and incorporates 42 C.F.R. Subsection 483.70(h). Petitioner rated these deficiencies as Class III deficiencies. By assigning the deficiencies that rating, Petitioner maintained that each deficiency presented "an indirect or potential relationship to health, safety and security of nursing home residents." Petitioner conducted a follow-up survey on March 1, 2001, and determined that the deficiencies under Tags F164, F332, and F465 were uncorrected, and, as a result, issued a conditional rating to the facility. The conditional rating continued until April 4, 2001, when Petitioner changed it to a standard rating. The 2567 constitutes the charging document for purposes of issuing a Conditional License. No other document was offered to describe the offenses, or deficiencies, which resulted in imposition of the Conditional License. In conducting its survey, Petitioner uses a document developed by the Health Care Financing Administration ("HCFA"), called the State Operations Manual. It provides guidance on how to interpret regulations. TAG F164 The 2567 from the January survey asserts, under Tag F164 which incorporates 42 C.F.R. Subsection 483.10(e), that the facility "failed to protect the right to privacy and confidentiality of residents' clinical records regarding meal intake and medications." The regulation states that residents have "the right to personal privacy and confidentiality of his or her clinical records." During the January survey, Petitioner's surveyor observed a nurse leave the residents' medications chart on the medication cart while the nurse was administering medications to residents. The medications chart was open and could be examined by anyone passing in the hallway. The surveyor believed that there was a potential that these confidential medications records could be seen by unauthorized third persons and therefore assigned the F164 deficiency. During the follow-up survey on March 1, 2001, the surveyor observed that the medication charts were no longer open and that particular "problem" had been corrected. However, during the March 1, 2001, follow-up survey, the surveyor noted a nurse performing an "Acu-check" test on Resident 16 in the hallway in the presence of three other residents. She also observed a nurse giving an insulin injection to Resident 17 in her abdomen in the hallway in the presence of residents. As a result of these observations, the surveyor believed that these residents' right to personal privacy in medical treatment was not being maintained and that the deficiencies identified as Tag F164 continued. The surveyor acknowledged that both residents could consent to the administration of treatment in the manner that was observed and, in the event they consented, their right to privacy in medical treatment would be preserved. She failed to inquire of the residents or the nurse as whether they had consented to the critical treatment. The Respondent's nurse/witness testified that Resident 17 is a retired nurse, is cognitive, and has previously requested that her insulin injection be given in the manner described by the surveyor. She further described giving the "Acu-check" test as described by the surveyor to Resident 16, who is cognitive, on other occasions, without Resident 16's objecting. She testified that the standard practice is to take the resident out of the resident population into the resident's room or some other private place to administer treatment. TAG F332 Petitioner charged in the 2567 for the January 2001 survey that Respondent exceeded the minimum prescribed level of error rate in medication administration. Tag F332, which incorporates 42 C.F.R. Subsection 483.25(m)(1), provides that "the facility must ensure that it is free of medication error rates of five percent or greater." During the January 2001 survey, the surveyors observed "the medication pass on the North and South wings with 6 nurses identified 5 errors out of 48 opportunities revealing a 10.4 percent medication error rate." Because it is impossible, as a practical matter, to observe the administration of all medication while conducting a survey, the protocol to determine the accuracy of medication administration is based on representative sampling. The surveyor will observe approximately 20 medication administrations (also called "opportunities for error"). If an error in administration is observed, 20 or so more administrations are observed. The surveyor will then project the facility's medication error rate based on the percentage determined by dividing the number of errors by the number of administrations. During the March 1, 2001, follow-up survey, the surveyor observed three errors in the first 20 or so medication administrations. She then observed 20 more administrations which were error free. There were a total of three errors in administrations; the result was an error rate of 6.9 percent which exceeded the minimum standard; had only two errors been observed the error rate would be an acceptable 4.6 percent. Failure to follow the physician's orders, failure to follow manufacturer's specifications, and not following accepted standards of practice are the most common medication administration errors. Both significant and insignificant errors are counted to determine error rate. During the March 1, 2001, follow-up survey, the three alleged medication administration errors were: (1) a nurse gave a resident Gentamicin, an antibiotic eye drop, in both eyes when the surveyor believed the Physician Orders called for administration in one eye; (2) a nurse was observed giving a resident 330 mg. of ferrous elixir when the Physician Orders called for 325 mg.; and (3) a nurse was observed giving a resident two Tylenol tablets when the surveyor believed that the Physician Orders called for only one Tylenol tablet. The surveyor believed the administration of Tylenol was a medication error because it did not follow the Physician Orders that read: "8/1/00, Meds, Q8Hr, Tylenol Tabs, 325 mg, (Acetaminophen/325 mg) Oral, Q8Hrs." Although the order reads "Tabs," it does not quantify the number of "Tabs" to be administered. The physician who prescribed the medication was not interviewed. The surveyor believed the indication "325 mg" limited the amount of dosage although it is acknowledged that this is a standard size Tylenol and that the therapeutic dosage is two tabs. The same Physician Orders has an entry that reads "10/12/99, Meds, Q4Hp, Tylenol caplets, 325 mg,(Acetaminophen/ 325 mg), For Temperature > 101 or C/O minor discomfort. 2 Oral as needed, q4H." The Physician Orders written on February 23, 2001, indicated "Gentamycin [sic] ophthalmic solution 1 gtt (drop) TID (three times a day) for 7 days." It is not possible to determine from the Physician Orders that a medication error had occurred. The surveyor's determination that the Gentamicin ophthalmic solution was improperly administered was based on the hearsay statement of a resident and additional documentary evidence not offered at the hearing and, therefore, is not accepted as credible. TAG F465 Petitioner charges in the 2567 from the January 2001 survey, that Respondent violated 42 C.F.R. Subsection 483.70(h) in that it failed to "provide a safe, functional, sanitary, and comfortable environment for residents, staff, and the public." The basis for this violation was: "[D]uring the initial tour of the facility on 1/22/01 on the South wing at approximately 10:00 a.m., several resident rooms had dirty linen on the floors in the rooms and bathrooms. Dirty towels, washcloths, and sheets were observed on the floor." Testimony revealed that these conditions were observed in four rooms on the first day and in one room on a later day. During the follow-up survey it was noted that this offending practice had been corrected. Testimony revealed that the procedure for the disposition of dirty linen, gowns, towels and washcloths was to place them in a hamper for transportation to the laundry. During the March 2001 follow-up survey, it was noted that "at 4:30 p.m., a caddie with toilet cleanser, a toilet brush, antibacterial hand cleaner and furniture polish was observed on a resident's overbed table in room #203." The surveyor observed this to be in violation of 42 C.F.R. Subsection 483.70(h), as it did not provide a safe environment for residents. The caddie was removed immediately after its discovery.
Recommendation Based of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order revising the March 1, 2001, survey report by deleting the deficiencies described under Tags F164 and F332, but confirming the existence of an uncorrected deficiency, Tag F465, and assigning a Conditional License to Respondent for the period March 1, 2001 to April 4, 2001. DONE AND ENTERED this 30th day of November, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of November, 2001. COPIES FURNISHED: Patricia J. Hakes, Esquire Paul Lauve, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310J St. Petersburg, Florida 33701 R. Davis Thomas, Jr., Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302 Diane Grubbs, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three Suite 3431 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three Suite 3431 Tallahassee, Florida 32308
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of assisted living facilities in Florida pursuant to chapters 429 and 408, Part II, Florida Statutes. At all times material hereto, Kipling Manor was licensed by AHCA as an assisted living facility. Kipling Manor is located in Pensacola, Florida, and operates a 65-bed facility, license number 7285, and holds a specialty limited health license. Norma Endress is a registered nurse employed by AHCA. She conducts surveys of nursing homes and assisted living facilities for compliance. Ms. Endress is supervised by Patricia McIntire, a nurse consultant supervisor for AHCA. Ms. McIntyre has been with AHCA for 13 years. Belie Williams is the administrator of Kipling Manor. He has been involved with health care services for approximately 35 years, and has been an administrator of ALFs for approximately 15 years. He has been involved with the Florida Assisted Living Association (FALA) and served on its board. Mr. Williams helped implement training sessions for ALFs in conjunction with FALA for the past eight years. Kipling Manor has two nurses who visit the facility to provide care to the residents. Elizabeth McCormick is an advanced nurse practitioner (ARNP) in family, psychiatric and mental health. She has been a nurse since 1983 and has extensive experience dealing with inpatient and outpatient psychiatric residents in long-term facilities. Nurse McCormick works with a VA facility providing inpatient and outpatient care on a high intensity psychiatric unit. She was also an assistant professor at the University of West Florida in the Mental Health Nursing Program. Nurse McCormick provides medical and mental healthcare for residents at several ALFs in Pensacola, including Kipling Manor. She sees patients at Kipling Manor several times a month. She manages the healthcare of residents, diagnoses illnesses, and writes prescriptions as needed. She describes Kipling Manor as not being a typical setting because her patients there are seriously mentally ill, which presents huge challenges. Angela Lavigne is a registered nurse certified by Medicare to provide psychiatric care to patients. She is employed by a company called Senior Care. Among other things, she works with assisted living facilities providing therapeutic counseling, assisting doctors with adjusting medication, and providing in-service training to staff of these facilities in regard to psychiatric care. Nurse Lavigne has been seeing patients at Kipling Manor for almost three years. She visits Kipling Manor approximately four times a week. At the time of the survey, she visited the facility once or twice a week. She provides patient care as well as in-service training to the staff regarding psychiatric issues. She also runs group sessions with the residents to make them feel more independent and feel more like they are in their homes. On July 12 through 14, 2011, Nurse Endress conducted an unannounced complaint survey of Kipling Manor that gave rise to the Amended Administrative Complaint and to this proceeding. Count I--Resident 8 Count I alleges that Kipling Manor failed to provide incontinent care for Resident 8 and failed to provide nail and facial care for Resident 6. Ms. Endress observed Resident 8 walking with a "med tech" to the "med room" to receive her medications. Ms. Endress observed wetness on Resident 8's clothes, and noticed the smell of urine. The med tech gave Resident 8 her medications, then assisted her to an open area where Resident 8 sat down. Ms. Endress observed Resident 8 for about two hours. Ms. Endress approached a personal care assistant (PCA), who was a new employee, and inquired of the PCA as to whether the resident was incontinent. As a result of this inquiry, Ms. Endress believed that this resident was incontinent. After approximately two hours had passed, Ms. Endress called this to the attention of the PCA, who then changed Resident 8 immediately. Ms. Endress determined that Respondent was "not providing care for this lady, incontinent care. They were not monitoring her." This determination was based in large part on her belief that Resident 8 was incontinent. However, Resident 8's health assessment indicates that Resident 8 needed supervision while toileting, but did not carry a diagnosis of incontinence. Ms. Endress acknowledged at hearing that supervision with toileting is not the same thing as being diagnosed with incontinence. Resident 8's health assessment also reflects diagnoses of personality disorder, dementia, and Alzheimer's among other conditions. Ms. McCormick provided health care services to Resident 8. She quite frequently is involved with residents who have toileting issues. Had Resident 8 developed skin problems because of toileting issues, she would have been aware of it. Ms. McCormick noted that the records indicated that Resident 8 received a skin cream three times a day to prevent such skin problems. Both Ms. Endress and Ms. McCormick are of the opinion that, while it is better to change a resident as soon as possible, a two-hour check is appropriate for someone with toileting issues. According to Ms. McCormick, if she were looking to determine whether there existed a direct physical threat to Resident 8, there would be monitoring for skin breakdown, redness or irritation, or a possible urinary tract infection (UTI). Neither Ms. McCormick nor Ms. Lavigne were notified or saw any signs of a skin infection, other skin problems, or a UTI regarding Resident 8. There was no evidence presented that Resident had any skin problems or UTI as a result of this incident or her toileting issues. Erica Crenshaw is a "med tech" and a supervisor employed by Kipling Manor. She provided care for Resident 8 and was on duty the days of the survey in question. Ms. Crenshaw verified that Resident 8 was on a two-hour check at the time of the survey. This involved checking to see if Resident 8 was wet or dry. If she were found to be wet, staff would take off the resident's brief, change and wipe the resident, put on a new brief noting the date and time, as well as recording the staff person's initials. When changing Resident 8, staff would apply a barrier cream, and check to see if any bed sores developed. Ms. Endress determined that this was a Class II violation because of the potential for skin breakdown and infection as well as potential for emotional harm, in that she perceived this as a dignity issue for Resident 8. Ms. Endress based this opinion in large part on her mistaken belief that Resident 8 was incontinent. Her supervisor, Ms. McIntyre, reviewed the classification recommended by Ms. Endress and concurred that Class II was appropriate because "[r]esidents, in particular elderly residents, left sitting in urine, there is a great potential for them to experience skin breakdowns, which would certainly have a severe negative impact on their physical health." Mr. Williams saw Resident 8 while Ms. Endress was conducting her inspection. He saw that she was wet from urine on the back of her clothes. He did not detect any strong odor of urine although he was close to her. Count I--Resident 6 Count I also includes allegations regarding Resident Ms. Endress observed Resident 6 with long facial hair (Resident 6 is female) and long, dirty fingernails. Ms. Endress interviewed Resident 6 regarding these observations. Based upon this interview, Ms. Endress believed that staff did not cut her facial hair or trim her nails, despite Resident 6 wanting them to do so. Ms. Endress estimated Resident 6's nails to be approximately one-quarter inch long but could not recall the length of her facial hair. Resident 6's health assessment reflects a diagnosis of dementia with poor short term memory, and that she needs assistance bathing, dressing, and grooming. Erica Crenshaw described Resident 6 as "a little difficult to work with." Staff works on nails, hands and feet, two days a week. If at first Resident 6 was resistant to having her nails trimmed, they would "give her space" then approach her again later. She described Resident 6's nails as "pretty decent." Resident 6 received health care from both Ms. Lavigne and Ms. McCormick. Both nurses are of the opinion that staff worked with Resident 6 to keep her nails in good shape. As a resident of an ALF, Ms. McCormick noted that Resident 6 had the right to refuse nail care and decide whether her nails needed to be trimmed. Ms. Lavigne informed staff that they needed to work with Resident 6 at her own pace, and to be careful not to make her combative. Ms. Lavigne treated Resident 6 for a wrist problem in mid-summer of 2011, when Resident 6 was in a splint for approximately six weeks, and received physical therapy. She described Resident 6's nails as "nice, round, nothing broken, nothing chipped. Every once in a while she's actually let staff put nail polish on them but as far as cutting them down, it's like an act of Congress to get her to sit down enough to trim them." There is no evidence as to what could have been under Resident 6's nails when Ms. Endress saw her. However, the evidence establishes that Resident 6's nails were tended to by staff on a regular basis, and that her treating nurse was not aware of any problem with them. Regarding facial hair, Ms. Lavigne never noticed any facial hair on Resident 6 other than having "a couple little whiskers here and there." Ms. Lavigne was Resident 6's treating nurse in the general time-period around the survey in question, and was never informed about any problems with Resident 6 regarding nails or facial hair, nor noticed any. Ms. Endress classified the findings she made regarding Resident 6's nails and hair as a Class II violation because she perceived it as a "dignity issue because women do not like facial hair on them." Ms. McIntyre confirmed the class determined by Ms. Endress, although the record is not clear why. Count II--cleanliness and maintenance Count II of the Amended Administrative Complaint alleges that Kipling Manor failed to honor the rights of residents by not providing a safe and decent living environment to prevent the spread of disease for all residents. The Amended Administrative Complaint alleges in pertinent part as follows: In an interview resident #3 on 7/12/11 at 9:00 am stated this place was not clean. He stated the cook will have gloves on his hands when he leaves the kitchen. The cook continues rolling the food down the hallway to the dining room while simultaneously rolling the open garbage container which is soiled. Without changing his gloves he will serve the food to the residents.1/ An observation of lunch on 7/12/11 at 12:00 pm revealed the cook serving turkey with gloved hands not using a utensil. Without changing his gloves he handled silver ware, moved a gallon of milk and was touching the dining room table. He was using the same gloved hand to serve corn bread. While serving food he never changed his gloves between clean and dirty. Other staff wearing gloves were serving lunch to residents and cleaning tables and pouring beverages without changing gloves. They were serving beverages touching the rims of glasses without changing clothes [sic]. During the survey, the following was seen: Bathroom floor for room 9 on wing 1 was dirty with build-up of dirt in the corners. Lounge area at the end of wing 1 had a broken recliner that was being used by a resident. The floor and furniture were soiled. Room and bathroom #3 on wing 1 had dirty floors with build-up of dirt along baseboards and the toilet lid was too small for the tank. Vents were clogged with dust. The door was too short for the opening; wood was missing on door frame and the threshold had broken tile. Dining room bathroom at the end of wing 2 had dirty floors with build-up of dirt along baseboards; around bottom of the toilet was black and the seal was cracked. Dining room floors were dirty and walls had dried food on them. Room 27 had filthy floors with build up along baseboards; dried spills were noted and the drywall had a hole in it. Wing 2 had drywall that was pulling away from ceiling and the ceiling had brown water spots: soiled dirty walls; dirty baseboards with build up of dust; spills on walls and vents dusty. Wing 2 had no baseboard near the shower; the cabinet had mildew on the outside surface; the wood was warped and peeling. The sink was soiled with dried brown substance. The door to the cabinet would not close. The baseboard wood near sink was split and the drywall had an indentation of the door knob. Room 21 floors were filthy and smelled of urine. Soiled clothes laid on the floor with soiled underwear which were observed while medication technician was assisting resident. No action was taken by the medication technician. Laundry room floors were filthy. There was no division between clean clothes and dirty clothes. Clothes were lying on the floor.2/ Based upon this complaint, Ms. Endress observed the dining room during a meal and toured the building. At hearing, Ms. Endress acknowledged that she did not see the cook touch the garbage pail or garbage and then touch food. She maintained, however, that she observed the cook while wearing gloves, touch food then touch "dirty surfaces," then go back and touch food on plates and touch the rims on glasses. Ms. Endress did not specify at hearing what she meant by "dirty surfaces," but in her report which was the basis for the Amended Administrative Complaint, she noted that the cook would touch food and then touch surfaces such as moving a gallon of milk, touching the dining room table, and handling silver ware. She also testified that she saw other staff wearing gloves who were serving residents, cleaning tables, and serving beverages without changing their gloves. Deborah Jackson is a personal care assistant (PCA), food server, and laundry worker at Kipling Manor. Ms. Jackson and one other PCA serve meals for about 60 residents. She received training in food service. She was working at Kipling Manor the days Ms. Endress was there for the survey. Ms. Jackson always wears gloves when serving the residents. If she touches anything besides food she changes gloves. For example, if she moves chairs, she changes gloves before resuming food service. She has never seen the other PCA touch other items then serve food. She was trained never to touch the rims of the glasses but to pick up glasses and cups from the side. She goes through "probably a whole box" of gloves in a day. According to Ms. Jackson, the cook stands behind the area and puts the food on the plates, preparing two plates at a time. She watches him prepare the plates of food. She and the other PCA then serve the food to the residents. The garbage can is kept in the back, not where food is being served. She has never seen the cook touch the garbage can then prepare plates of food. When he has finished, he takes all "his stuff" out on a cart, while the PCAs clean up. If a resident spilled food, the PCAs, not the cook, would clean it up. L.N. was the cook at the time of the survey inspection. L.N. was hired in April 2011 and received training in infectious control and food service sanitation. L.N. no longer works for Kipling Manor.3/ Billie Williams, as administrator of Kipling Manor, confirmed Ms. Jackson's description of the cook's role in serving dinner. That is, that the cook prepared plates of food and the PCAs then served the residents. At hearing, Ms. Endress essentially reiterated her findings regarding the other allegations in count II dealing with the cleanliness and condition of the facility. No further proof was offered regarding these or any other allegations in the Amended Administrative Complaint. Mr. Williams' testimony contradicted much of what Ms. Endress described regarding the cleanliness and condition of the facility. Specifically, Mr. Williams noted that on the day of the survey inspection, maintenance men were repairing a ceiling leak. The ceiling leak was the cause of the "drywall pulling away from the ceiling" and the "brown water spots" on the ceiling cited in the Amended Administrative Complaint. These conditions were the result of the water leak and were in the process of being repaired at the time of the survey. The workers arrived early in the morning and cut drywall from the ceiling where the water dripped down on it. They necessarily used a ladder to do the ceiling repair work. A maintenance man stood at the bottom of the ladder and, if a resident approached, would escort the resident around the ladder. Regarding the issues of cleanliness, Mr. Williams has two housekeepers, a person who does the laundry, and two maintenance men. Mr. Williams acknowledged that there may be a small wax buildup along baseboards or on the inside corner of a door. However, the two maintenance men wax, strip, and buff the floors throughout the building. The floors are swept and buffed every day. The baseboards (wall to floor) are dust mopped twice a day. Regarding the allegation that there was black around the bottom of the toilet and the seal was cracked in the bathroom off the dining room area, Mr. Williams went to that room with the maintenance men to personally inspect it. He observed some discoloration on the floor where the toilet may have overflowed at some time and got underneath the tile. The maintenance men cleaned this immediately and replaced the tile. Regarding the allegation that there was mildew on a bathroom cabinet, Mr. Williams inspected the black mark and found it to be a tire mark from a wheelchair. He found no mold or mildew. The black mark was removed. There is a separate laundry room where washers and dryers are located. Any clothes on the floor are for sorting or separating by color or other reason prior to washing. Once clothes are washed, they are taken back to the residents' rooms immediately. Clean sheets, towels, and wash cloths are placed on wooden shelves that were built for that purpose. There is no evidence that establishes that clean and dirty clothes were mixed on the floor. Mr. Williams also inspected the recliner. The recliner has snap-on armrests and one had been snapped off. The maintenance men snapped the armrest back on the chair, and it was easily repaired. Regarding the allegation that the drywall in a bathroom had an indentation of the door knob, Mr. Williams inspected that and found that the doorstop on the bottom had broken off. There was an indentation in the wall the size of a doorknob where the door had been opened hard. This was repaired by the maintenance men. Regarding the allegation of vents being clogged with dust in a room and bathroom, Mr. Williams found "a little" dust on a vent which was cleaned immediately by staff. He then instructed staff to check the vents daily for dust build-up. Mr. Williams could not find a door that was too short for the opening, and noted that this would be a fire code violation. Kipling Manor is current on fire and health safety inspections. In general response to the allegations regarding cleanliness and maintenance and to a question asking whether he keeps a well-maintained building, Mr. Williams stated: We try our best. I mean, I have--you know, when you have incontinent residents who are demented, who are bipolar or suffering from depression, they will do things. And, yes, they do. And like, I think in one of the reports she wrote up, there was wet clothes on the floor. Well, if a resident, some of them are semi-independent, too. I mean, they take care of their own needs. If they had an incontinent issue that morning, and they took their clothes off and left it there on the floor, you know, they expect the staff to pick it up and take it to a laundry room when they come through. You know, we do, I think, we do a darn good job given the -- a lot of my residents have been homeless, have never had any structured living. Nobody else in town takes them, but I have. Ms. Endress classified the alleged violations in Count II as Class II "because of the potential for harm to residents which could occur from an unsafe environment and potential spread of infection." Ms. McIntyre agreed with Ms. Endress that "the totality of all the findings are what drove the deficiency to be considered a Class II." Count III--Resident 4 medications Count III alleges that Kipling Manor failed to administer medications according to the medication observation record (MOR) for 1 out of 9 sampled residents (Resident 4). During lunch, Ms. Endress observed Resident 4 become agitated, rub his face, and complain loudly in the dining room. Following an observation of this resident and a conversation with him, Ms. Endress reviewed Resident 4's medication observation record (MOR) and health assessment. Ms. Endress determined that Resident 4 had not been given one of his medications, Interferon, when scheduled. The MOR shows a time for administration as 8 a.m. According to Ms. Endress, on the date this took place, July 12, 2011, the MOR was blank in the box that should be initialed when the medication was administered. The MOR in evidence, however, reflects initials in that box (i.e., it is not blank). When a drug is self-administered, the staff member initials the box for that day. Erica Crenshaw recognized and identified the initials in the box for that day as those of former unit manager Tekara Levine, who trained Ms. Crenshaw. According to Mr. Williams, Ms. Levine, was certified in the self- administration of medications and was a trustworthy employee. Ms. Endress observed Resident 4 wheel himself from the dining room to the medication room and self-administer his medication. This occurred around noon that day. Ms. Endress determined this to be a Class II violation as she believed it directly threatened the resident emotionally. She based this in part on the resident's demeanor before the medication and afterwards, and the comments the resident made to her. Resident 4 is one of Nurse Lavigne's patients. Resident 4 has a diagnosis of MS, major depression, post traumatic stress disorder, a paranoid psychosis, and anxiety and affective disorder. He receives Interferon for his MS. It is injectable and he self-administers it every other day. According to Nurse Lavigne, there is no doctor's order stating that the Interferon must be given at 8 a.m. or any other particular time. The injection can be administered at any time during the day. Resident 4 sometimes gets confused about his medications. He gets extremely upset if he thinks he has not gotten his medications. He will sometimes tell her (Nurse Lavigne) that he did not receive a particular medication when he, in fact, did receive it. Once he is shown the MOR indicating that he has received his medication, he visibly calms down. He does not like to leave his room because he thinks somebody is changing stations on his TV. Regarding his once-a- day medications, staff will wait until he is ready to come out of his room because he can get agitated. He sometimes gets upset if there are a lot of people around him, such as in the dining room. Nurse Lavigne does a full assessment when she sees Resident 4. She was not aware of any problems with Resident 4 during that time period regarding his medications. While the record is unclear as to why Resident 4's MOR shows an administration time of 8 a.m., the evidence established, through Nurse Levine, his treating nurse, that there is no doctor's order requiring that the drug be administered at that particular time. The evidence also established that Resident 4 self-administered his medication at noon on July 14, and that this was initialed by a staff member on his MOR. Count IV--Resident 1 medications As a result of a complaint received, Ms. Endress interviewed residents about their medications and spoke to a new staff member. Based upon these interviews, Ms. Endress determined that one of Resident 1's medications (Flexeril) had not been available for one dose on July 13, 2011, and another of this resident's medications (Visteril) had not been available from June 23 until July 12, 2011). Ms. Endress classified this alleged violation as a Class II because she determined that that it directly affected the resident psychologically and physically. Resident 1 had a diagnosis of COPD and has an anxiety disorder. She is alert and oriented. Resident 1 was prescribed Flexeril to be administered every evening, and Vistaril and Ativan for anxiety. She is to receive Ativan twice a day and PRN (as needed) and Visteril before bed and PRN. Each day a medication is administered, the residents' MORs are initialed by staff in a box indicating each day of the month. However, if the resident runs out of a drug, the staff member will put a circle in the box representing that day and makes a note on the back of the MOR. No circles or notes appear on Resident 1's MOR indicating that either drug was not available. Resident 1 is a patient of Nurse McCormick. Resident 1 becomes anxious or agitated if she does not receive her medication for her anxiety disorder. Nurse McCormick considered Resident 1's anxiety disorder well controlled by the medications. Resident 1's MOR reflects that she received Visteral from June 1 through 30 at night as ordered and received it PRN several times prior to June 23, 2011, but did not receive it PRN the rest of the month of June or July 1 through 14. She also received Ativan twice a day routinely in June and July and five times PRN during the period June 23 through 30, 2011, and four times during the period July 1 through 14. According to Nurse McCormick, either medication was appropriate for controlling Resident 1's anxiety disorder. Resident 1's MOR reflects that she received Flexeril on June 30, 2011. Nurse McCormick was not made aware at any time that Resident 1 was not receiving any of her medications. As the treating and prescribing nurse, missed or unavailable medications would have come to Nurse McCormick's attention. Resident 1 was not anxious, nervous or agitated when interviewed by Ms. Endress on July 12, 2011. There is no competent evidence that Resident 1 displayed any signs of anxiety, nervousness or agitation during the survey or during the times that the Amended Administrative Complaint alleges that she did not receive her medication. Nurse McCormick found the staff of Kipling Manor to be careful with all residents. She has been to the facility at various times of the day from early in the morning to late into the evening. Nurse McCormick is of the opinion that the staff takes care of all its residents and provides them with dignity. Despite Kipling Manor's resident population of seriously mentally ill residents, Nurse McCormick is of the opinion that the facility manages its residents with dignity and care. Count V--Background Check The Amended Administrative Complaint alleges that one staff member of Kipling Manor, the cook, had not been background screened. Based upon record review and staff interview, Ms. Endress determined that the facility did not complete a level 2 background check for 1 out of 8 sampled staff members. A record review revealed that this employee had been hired in April 2011. On April 26, 2011, the employee in question signed an Affidavit of Compliance with Background Screening Requirements, using AHCA form #3100-0008. By signing this form, the employee attested to never having been arrested for, pled nolo contendere to, or convicted of certain disqualifying offenses. Mr. Williams did not complete a background check on the cook because he did not think the cook was covered under the law. That is, he did not think the law applied to the cook because of the lack of personal contact with the residents. The cook is present during meal times serving plates of food to the dining workers who then directly serve the residents. The living areas are accessible to the cook. This employee no longer works at Kipling Manor. The record is not clear as to when he stopped working there. Ms. Endress determined that this constituted a Class II deficiency as she believed that it could potentially lead to harm to residents of the facility. According to Ms. McIntyre, AHCA always imposes a Level II deficiency for failure to have a level 2 background screening for employees. Both Ms. Endress and Ms. McIntyre testified at hearing regarding what constitutes Class II and Class III deficiencies. In several instances, Ms. Endress classified a violation or deficiency that could potentially result in harm to a resident as a Class II. Ms. McIntyre testified that "a potential harm to a resident could be a class II deficiency." She described a Class III as one that "indirectly threatens the physical, emotional health or safety of a resident. . . . indirectly or potentially." The Agency provided a mandatory correction date of August 1, 2011, for all five counts in the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order imposing a fine of $2,000, imposing a survey fee of $500, and dismissing the remaining allegations of the Amended Administrative Complaint against Respondent, Kipling Manor. DONE AND ENTERED this 1st day of May, 2012, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2012.
The Issue The issue is whether Respondent violated the Florida Civil Rights Act of 1992, as alleged in the Petition for Relief filed by Petitioner in May 1998.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: In this proceeding, Petitioner, Jerrylene Barr, who is an African-American, contends that in May 1994, Respondent, Columbia Ocala Regional Medical Center (Respondent), unlawfully terminated her from employment as a registered nurse on account of her race. Respondent has denied the charges and contends instead that Petitioner was terminated after she negligently overmedicated a patient, in addition to her prior performance of medication errors over a two-year period. After a preliminary investigation was conducted by the Commission on Human Relations (Commission), which took some three years to complete, the Commission issued a Notice of Determination: No Cause on April 27, 1998. Although not specifically established at hearing, it can be reasonably inferred from the evidence that Respondent employed at least fifteen employees for each working day in each of twenty or more calendar weeks in the current or preceding year and thus is an employer within the meaning of the law. Petitioner began working for Respondent as a nurse in January 1992. Between September 1992 and May 1994, a period of seventeen months, Petitioner had twelve documented errors in giving medications to patients under her supervision. This was more than any other employee at Respondent's facility. During Petitioner's tenure at Respondent's facility, Respondent had a Medication Error Policy in effect. This policy outlined the procedures and penalties for medication errors. For each error, points were assigned according to the severity and frequency of errors. The policy provided, however, that management had the right to terminate an employee at any time for a serious medication error regardless of whether the employee had accumulated any points under the policy. Petitioner was aware of, and understood, this policy. On May 2, 1994, Petitioner was working the night shift at Respondent's facility and was in charge of six patients on the third floor. One of her patients was a 78-year-old male who was scheduled to have surgery for a life-threatening abdominal aortic aneurysm. The attending physician had written on his orders that day that the patient was to be given "Halcion 0.125 milligrams PO noon." This meant that he was to receive one-half of a .25 milligrams tablet of Halcion, a narcotic-type drug, by mouth at noon on May 3, the following day. The order was attached to the patient's chart. Around 6:30 p.m. on May 2, 1994, Petitioner mistakenly gave the patient five Halcion 0.25 milligrams tablets by mouth, or ten times the prescribed dosage. Although Petitioner did not initially disclose this fact to other personnel, she eventually conceded that she had made an error. When the patient was found in a comatose state a few hours later, three physicians were called to check on his condition, including his primary physician, a critical care physician, and a neurologist. Not knowing that Petitioner had overmedicated the patient, the primary physician initially believed the patient had suffered a stroke. The patient was admitted to the intensive care unit (ICU), a catheter was inserted, and he was placed on a respirator. After reading the medication record, the ICU nurses discovered that the patient had been overmedicated. The patient eventually recovered, but his surgery had to be postponed, which might have resulted in a burst aorta. His family later sued the hospital for Petitioner's negligence. Because of the serious nature of the error, and given Petitioner's past history of medication errors, Respondent terminated Petitioner on May 3, 1994. The employment decision was not based on Petitioner's race, but rather was based on "her poor work performance overall." There is no evidence as to whom, if anyone, was hired to replace Petitioner. The termination was wholly consistent with Respondent's Medication Error Policy. At hearing, Petitioner contended that the hospital did not terminate other nurses for similar offenses. However, during the same period of time that Petitioner was employed by Respondent, another nurse, M. C., a Caucasian female, was also terminated for making a serious medication error with a narcotic- type drug. Although M. C. had an otherwise "very good" record at the hospital, and did not have a history of medication errors, Respondent nonetheless terminated her since her conduct, like that of Petitioner, constituted a "life-threatening nurse practice error." Petitioner also contended that another nurse on duty that evening assisted her in calculating the Halcion dosage and this should relieve her of any responsibility. Although there was no independent testimony to corroborate this claim, even if true, the patient was under the direct supervision of Petitioner, and it would not diminish Petitioner's responsibility for placing the patient in a life-threatening situation.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Commission on Human Relations enter a final order dismissing, with prejudice, the Petition for Relief. DONE AND ENTERED this 14th day of April, 1999, in Tallahassee, Leon County, Florida. DONALD R. ALEXANDER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (850) 488-9675, SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of April, 1999. COPIES FURNISHED: Jerrylene Barr Post Office Box 289 Reddick, Florida 32686 Kip P. Roth, Esquire 2501 Park Plaza Nashville, Tennessee 37203 Sharon Moultry, Clerk Florida Commission on Human Relations Building F, Suite 240 325 John Knox Road Tallahassee, Florida 32303-4149 Dana A. Baird, General Counsel Florida Commission on Human Relations Building F, Suite 240 325 John Knox Road Tallahassee, Florida 32303-4149
The Issue Whether Respondent can practice medicine with reasonable skill and safety to his patients.
Findings Of Fact At all times relevant hereto Raul F. Nodal, Respondent, was licensed by the Florida Board of Medicine as a medical doctor. Dr. Nodal is a board certified neurologist. The Department of Business and Professional Regulation is a state agency charged with enforcing provisions of Chapter 458, Florida Statutes. The history of Respondent's problem with chemicals is noted in Exhibit 4, the medical records of Respondent which was admitted into evidence. However, those records were not properly authenticated and are admissible only as hearsay evidence which corroborates other admissible evidence. Respondent acknowledged that the stress of his brother's apparent murder in 1985 created stresses which he relieved with sedatives and that he developed a dependency on those tranquilizers which progressed to the point where he felt his use was out of control. In the summer of 1990 Respondent found himself taking more and more tranquilizers just to stay calm enough to conduct his practice. A friend referred Respondent to Dr. Krone of the Physician's Recovery Network (PRN) in Tampa, Florida. The PRN is a non-profit association under contract with the Department of Business and Professional Regulation to monitor the progress of Florida physicians admitted to the impaired physicians program for treatment for alcohol or drug dependency and to act as agent for the Department and liaison between the practitioner and the treatment providers. Dr. Krone referred Respondent to the treatment program at South Miami Hospital where Respondent entered and completed the 28 day residence program. Upon completion of the inpatient treatment on 10/18/90 Respondent entered into the first of three Advocacy Contracts in which he agreed, inter alia, to abstain from further use of medications, alcohol or other mood altering substances including over the counter medications unless ordered by his primary care physician; to participate in a random urine drug or blood screen program through PRN; to attend various self-help programs; to provide release forms for urine screen results, treatment center records, therapist reports and other written and verbal information (to comply and in compliance) with the above request; and to withdraw from practice for evaluation at the request of the PRN if any problem develops. Upon his release from South Miami Hospital Respondent was given the name of a doctor as his contact person in Tampa. Because his contact turned out to be a colleague with whom Respondent had worked, Respondent did not feel comfortable sharing his problem with this doctor. Accordingly, he did not do any follow-up care at that point except some meetings he attended on his own. In April, 1991 a friend of Respondent who was being cared for by Respondent in an emergency situation died within hours of a brain hemorrhage. Respondent resumed taking tranquilizers to relieve his stress and a random urine sample taken 5/23/91 tested positive for barbituates. Respondent was then referred to Glenbeigh Hospital in Tampa for an evaluation. He was admitted on 6/03/91 and discharged 6/12/91. Respondent testified he stayed at Glenbeigh close to two weeks. Upon discharge from Glenbeigh he entered an after care program with an addiction counselor in a one on one situation. After a few months his funds ran out and Respondent stopped the program. He continued sporadic attendance at after care groups such as AA and NA. On July 18, 1991 Respondent signed another Advocacy Contract with PRN similar, if not identical, to the contract signed 10/18/90. As the result of a random urine sample which tested positive for barbituates Respondent was requested to enter a long term treatment program. He was admitted at Talbott-March Recovery Program (TMP) in Atlanta, Georgia on December 9, 1991 for evaluation. At TMP Respondent received neuropsychological testing and it was recommended he enter a long range rehabilitation program for three to six months. Respondent testified he could not afford the recommended treatment and he was discharged and returned to Tampa where he was supervised by Dr. David Myers at Health Care Connections. Although Respondent denies taking any drugs other than those noted in findings 9-14 above at any time, competent evidence was presented that a urine sample taken April 1, 1992 tested positively for methaphetamine; on November 3, 1992 a sample tested positive for barbituates; and on March 22, 1993 a sample tested positive for amphetamines and barbituates. Respondent's denial of having used tranquilizers since 1991 despite the positive samples noted in the above finding and of his persistance in disclaiming any present dependency clearly indicates Respondent is in the denial stage of addiction and is failing to face the fact that he has a serious problem. Upon receipt of these 1992-1993 results PRN found Respondent to be not in compliance with the Advocacy Contracts he had signed; and Dr. Roger A. Goetz, Director of the PRN, submitted a complaint to the Department of Professional Regulation alleging that Respondent was unable to practice medicine with a reasonable degree of safety to his patients by reason of his impairment due to chemical dependency. This complaint is predicated on Respondent's failure to comply with the provisions of his Advocacy Contract. Urine samples referred to above were taken and tested in accordance with standard procedures established to insure the integrity of the sample and of the test results. Those reports accurately reflect the presence of illicit drugs found in urine samples provided by and from Respondent. Petitioner's expert witness, Dr. Michael Sheehan, M.D. is board certified in psychiatry and specializes in addiction psychiatry. Dr. Sheehan's opinion that Respondent cannot practice medicine with a reasonable degree of safety to his patients by reason of his impairment due to chemical dependence is based upon the documents contained in Exhibit 4 which is a medical record of Respondent maintained by the PRN from his entry into the impaired physician's program in 1990 until the complaint was submitted by the PRN to the Department. Although Exhibit 4 purports to be the business records of PRN they were not authenticated as such at the hearing. Numerous documents in Exhibit 4, particularly the drug screens, were admitted into evidence by virtue of witnesses testifying to their authenticity. Other documents in Exhibit 4 were corroborated by Respondent's testimony. Thus, those parts of Exhibit 4 which were admitted by other means are sufficient to support the opinion of Dr. Sheehan that Respondent is unable to practice medicine with reasonable skill and safety to patients by reason of his chemical dependence; and Dr. Sheehan's opinion that Respondent is in denial of his addiction. Respondent's expert witness, Christie Roberts, holds a Ph.D. in counseling psychology and specializes in addiction therapy. Dr. Roberts administered the Minnesota multifacet personality inventory (MMPI) to Respondent. All of the ten clinical scores assigned to Respondent from the test were in the normal range. On the McAndrews scale, an important scale in determining addiction, Respondent's score was below the established cutoff score indicating addition. Above this cutoff Dr. Roberts usually finds addiction. However, when the McAndrews is below the cutoff, Dr. Roberts acknowledged the possibility that the person tested could have an addiction problem. Petitioner's second expert witness Dennis Brightwell, M.D. has been board certified in psychiatry since 1976 and has treated literally thousands of substance abusers, principally alcoholics. Dr. Brightwell interviewed Respondent for one hour and fifteen minutes and considered the MMPI performed by Dr. Roberts. Dr. Brightwell did not review the medical records of Respondent or administer any other test to Respondent, but based his opinion on the interview and the MMPI. Dr. Brightwell opined Respondent could practice medicine with reasonable skill and safety to patients and did not currently present that he was substance dependent. Based upon the information provided by Respondent Dr. Brightwell further opined that "given the fact that in 1990 he was using it on a regular basis, there is a risk that he could resume that. And I think the appropriate approach to insure that that doesn't happen would be very tight behavioral control to make sure it isn't occurring. Assuming that he is not so sick from substance abuse that he can't make the decision to not use, all he would need is very close monitoring to give him the opportunity, really, to make the decision on a regular basis not to use." Respondent's front office employee who had worked 1 1/2 years for Respondent observed no abnormalities in Respondent's conduct during the time she worked for him. She never saw him self-medicate or appear under the influence of drugs or alcohol. Two medical doctors who have known Respondent both professionally and socially for several years and who testified in these proceedings have never observed Respondent under the influence of drugs or alcohol and consider Respondent to be a capable neurologist. One of these doctors attends a weekly meeting of a group, including Respondent, who study philosophy and discuss the writings of philosophers. This witness deems Respondent an intellectual member of that group.
Recommendation It is recommended that Respondent be found guilty of violation of Section 358.331(1)(s), Florida Statutes and that his license to practice medicine be revoked. It is further recommended that imposition of that discipline be stayed for a period of five years probation under such terms as the board may direct but to require Respondent to remain in the impaired physician's program and submit random urine samples as directed, and that, if any one of those samples tests positive for banned chemicals, the stay be vacated and the license revoked. However, if Respondent successfully completes this five years' probation, the revocation shall be vacated and Respondent's license be restored to good standing. DONE AND ENTERED this 7th day of September, 1993, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of September, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-3972 Proposed findings submitted by Petitioner are accepted except as noted below. Proposed findings neither noted below nor contained in the Hearing Officer's findings were deemed unnecessary to the conclusions reached. 13. Rejected. This hearsay evidence in Exhibit 4 was not corroborated by admissible evidence. Proposed findings submitted by Respondent are accepted except as noted below. Those proposed findings neither included in the Hearing Officer's findings nor accepted below were deemed unnecessary to the conclusions reached. 4. Rejected. Respondent testified that he felt "more and more tense" for the next several weeks following the death of his friend and he "remembers taking something for sleep or something for, like a tranquilizer during the day." 11. First sentence rejected. Dr. Roberts testified that she virtually never sees a patient who has an elevated McAndrews scale who was not also addicted. 13. Accepted. But see Hearing Officer's Nos. 21 and 22. COPIES FURNISHED: Michael K. Blazicek, Esquire 9325 Bay Plaza Boulevard Suite 210 Tampa, Florida 33619 Grover C. Freeman, Esquire 201 East Kennedy Boulevard Suite 1950 Tampa, Florida 33602 Jack McRay, Acting General Counsel Department of Business and Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Dorothy Faircloth, Executive Director Department of Business and Professional Regulation Board of Medicine 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792
