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 At all times pertinent to the allegations involved in this hearing, Respondent, Robert A. Lieberman, was licensed to practice medicine in the State of Florida. John P. Spanogle, an investigator with the Department of Professional Regulation since 1980 and with the Board of Medical Examiners prior to that back to 1975, in November, 1979, was requested by representatives of the Orlando Florida Police Department to work with their detectives in several ongoing drug investigations. Respondent was not the subject of any of those particular Orlando Police Department investigations. However, during the course of these investigations, Mr. Spanogle secured certain prescriptions for Class II controlled substances that were written by the Respondent. As a result of these prescriptions, Mr. Spanogle interviewed the Respondent on July 7, 1982, at Respondent's office. At the outset of the interview, Mr. Spanogle advised Respondent of the nature of the allegations and of his rights regarding being questioned. He found Respondent to be extremely cooperative and received full answers to the questions asked, as well as patient release forms and patient records as to the patients listed in the various counts of the Administrative Complaint. During the course of the interview, Mr. Spanogle and Dr. Lieberman discussed several of the doctor's patients and the prescriptions he had written for them over the period in question. Dr. Lieberman seemed surprised he had prescribed so many Percodan and other drugs and could not readily explain why he had written so many prescriptions. Only one of the doctor's former patients testified for the Petitioner at the hearing. This was Linda Gorsuch Creed, a/k/a Linda Clary Morgan, the individual described in Count I of the Administrative Complaint. Ms. Creed is a former drug abuser who started abusing drugs when she was 18 years of age. She is now 26. During the course of her drug abuse, she used such substances as heroin, Dilaudid, Demerol, and others, injecting them into her arms and hands. She first saw Respondent in early 1979 for the purpose of securing drugs. Dr. Lieberman did not know this, however, because her stated complaint was of not being able to have sex without pain. This, however, was false. During the first visit, she was examined by the Respondent and was nude except for the examination gown. She cannot state whether she had drug injection track marks on her arms, but imagines she did since she was using drugs at the time. She does not know whether Respondent saw them, if in fact she had them. Respondent denies noticing any track marks on the witness; and on the basis of the evidence as presented, it can be concluded, reasonably, that Dr. Lieberman was not aware that this patient was in fact a drug abuser. During the first visit, she asked for Dilaudid and Valium and was given a prescription for both. Several months later, she again visited Dr. Lieberman for the purpose of securing drugs. On this visit, she complained of cramps, which again was not true, but at the conclusion of the visit was issued a prescription for Dilaudid. Approximately four years later, she again visited Respondent for the purpose of procuring drugs. At this time, she was mainlining and presumes that she had tracks which she feels may have been seen by the doctor. However, she asked for and received drugs based upon her represented "illness" and the Respondent's examination of her. Just about this time, she was arrested for drug abuse. At the time of her arrest, she had a prescription bottle for Dilaudid and one with Valium in it, both of which she had received from the Respondent. While she was out on bond, she again went to see the Respondent and asked for drugs. He refused, however, to give her any at this time because he had finally become aware that she was abusing drugs. She saw him several times thereafter and, on each occasion, he gave her only legitimate prescriptions; and she has not taken any illegal drug since 1980. The testimony of Dr. Lieberman on this same patient is consistent with that of the patient herself, though from a different perspective. The doctor's records reflect that the first visit from this patient on January 10, 1979, concerned her claim that she had had no period for three months and was in great pain. Examination revealed that her stomach was distended. He did a pelvic examination and found that her vagina was inflamed and she had a vaginal discharge. He gave her antibiotics for the infection and suggested that she have a laparoscopy examination in which a light device is passed through the navel into the fallopian tubes. The conditions described by the patient, if true, are in fact painful. The lack of period can be extremely painful because as a result the organs are swollen with fluid. The vaginal discharge and the history associated therewith indicated a possibility of pelvic disease and an inflammation of the fallopian tubes. It was for this reason that the laparoscopy was suggested. Because it was obvious that the patient was suffering great discomfort and because of her representation that Dilaudid was all that helped her (she was allergic to codeine and aspirin), he prescribed that drug for her. It is significant to note here that her allergy to codeine and aspirin limited the painkillers she could take and, as a result, which he could prescribe. He states that at the time of the examination, he saw no drug tracks on her body and did not know that she was an addict. He cautioned her on Dilaudid's addictive propensity and wanted her to have the laparoscopy so as to get her off Dilaudid as soon as possible. Dr. Lieberman was again visited by Ms. Creed in March 1979, approximately two months after the first visit. During this second visit, in which she stated she again had no period in the intervening two months since the first visit, the examination reflected that her stomach was tender, as were her organs, as well. The doctor gave her a hormone to start and regulate her periods and Dilaudid for the pain. On each prescription, Dr. Lieberman prescribed 20 capsules of Dilaudid. This drug is for severe pain, and he prescribed it only because, in his professional judgment, he felt she was in pain severe enough to justify it. Wilda Sue Boudreaux, another of Respondent's former patients, went to see him in May 1979, for the treatment of female problems. Dr. Lieberman recommended she have a hysterectomy, to which she agreed. She went into the hospital on May 23, 1979, for that operation and a bladder tac with removal of preexisting adhesions. Both operations were successful, and she was released after seven days' hospitalization. Dr. Lieberman saw her several times during her postoperative course of treatment. The surgery was done during the second or third day she was in the hospital. After the surgery, she was having severe pain and complications with a nerve in her leg that had been nicked during the hysterectomy surgery. After she was released from the hospital, because of these conditions, she was in constant, severe pain to the point she could not walk. Pain radiated through her leg and her lower body. She communicated these complaints to the doctor and received from him a prescription for Percodan. The Administrative Complaint alleges she received prescriptions on June 4, 5 and 19 and September 4 and 12. Ms. Boudreaux admits having received all prescriptions except the one on June 5 and denies emphatically that she received prescriptions for Percodan two days in a row. At the time the doctor prescribed Percodan for her, he told her it was a strong drug and should be taken carefully. She requested it, however, because it was the only drug that helped her. A couple of months after this surgery, she developed a urinary infection which resulted in severe pain during urination. She also continued to have severe pain in her left side where the leg nerve damage was and repeated pain from the prior surgery. She went back to the Respondent for a follow-up visit, and he hospitalized her for further tests. As a result of the tests, it was determined that the pain was due to severe nerve damage and that the pain would continue for some extended time until the nerve damage healed. Ms. Boudreaux considers Dr. Lieberman to be a good doctor who was concerned about her as a patient and who, at the time he gave her a prescription, explained to her why she was having the problems, what drugs he was giving her and what the drugs were for. It is her opinion that, throughout the entire period of time she was in contact with him, he appeared to be concerned about her as a person, not only as a patient. Respondent's testimony regarding his treatment of this patient was consistent with hers. He first saw her in March 1979, when she had a complaint regarding constant vaginal bleeding, painful periods and, as a result, he determined that she needed a complete hysterectomy, including complete removal of the tubes and ovaries, and surgery for preexisting bladder problems. During that operation, she sustained damage to a nerve which resulted in constant pain in her leg and abdomen. Nerve damage is one of the slowest types of damage to heal. As a result, this patient experienced constant pain over a long period after the surgery. On top of that, she developed a urinary tract infection as a result of the bladder surgery. As a result, she was maintained on Percodan until the infection cleared up and the nerve damage repaired itself. In the doctor's opinion, all the prescriptions for Percodan were appropriate. It is important to note here and with regard to the other allegations not the date of the prescriptions, but when and how they were to be used. Ms. Boudreaux is a school bus driver and a very responsible person; and Dr. Lieberman felt it was appropriate to prescribe Percodan as he did for her to stockpile them so that she would not have to come back into his office so often. In fact, she did not come back after June 19 until September 4, almost three months later. At that point, she still had the nerve damage and the bladder infection was first discovered. Petitioner made much of the fact that there may have been a less addictive drug that could have been used, both for this patient and for Linda Creed. Respondent claimed, however, that, based on his knowledge of the case of the individuals, he had no reason to disbelieve them; and in the case of Linda Creed, when she said Dilaudid had worked previously, he prescribed that in good faith. There is no evidence to show he did other than that in any case. Regarding the allegations pertaining to patient Patricia Rousseau, the patient information reflects that when first seen by Dr. Lieberman, Ms. Rousseau was a 30-year-old waitress with one child. She appeared well kept and was the sole support of herself and her child and needed to continue to work. At the first visit on July 9, 1979, Ms. Rousseau came in for an abortion, which was accomplished. At the time of her release, Dr. Lieberman prescribed 20 Percodan tablets to be taken one every six hours because, in this case, he thought it was medically indicated. Ms. Rousseau indicated she was in severe pain; and, based on the doctor's experience, he was convinced that, as a result of the procedure followed surgically, the pain could last for at least five days, which was the time it would take to use 20 tablets, taking one every six hours. Dr. Lieberman saw Ms. Rousseau again in January 1980. By this time, she had gotten pregnant again and wanted another abortion. She advised him that she had been to a clinic for that procedure and had developed an ovarian cyst. When Dr. Lieberman examined her, he felt that she could have a cyst, which, in his opinion, is a painful condition, and gave her medication for it. Here, he feels Percodan was indicated because of the fact that the condition arose from a second abortion and the additional pain that went along with it. Along with this condition, she also had dismenhorreah, a condition manifesting itself in painful periods, which, according to the Respondent, can be extremely painful and, in some women, totally disabling. Considering the fact that the patient needed to continue to work, as she was the sole support of herself and her child and could not be bedridden because of her period for three to five days each month, he felt Percodan was indicated, which he prescribed 15 or 20 at a time once a month for use during her period. The quantities prescribed were not, in his opinion, excessive. An additional patient who visited Respondent and whose course of treatment was considered to be improper by Petitioner was Martha Star Curtis, whose first visit to Respondent was on July 27, 1978. She was complaining of lower abdominal pain which, upon examination, turned out to result from a pregnancy. On August 2, 1978, this pregnancy was aborted. Her medical history, taken by Dr. Lieberman, revealed a prior ectopic pregnancy in the right tube and a lost tube and ovary. The following year, she had a cyst removed from her left ovary. At her first postoperative checkup, three weeks after surgery, Dr. Lieberman noticed a small ovarian cyst. When she came back a month later, the cyst was larger and was very painful. This pain related to the cyst was magnified because of chronic pelvic inflammatory disease, and Dr. Lieberman proposed to do a laparoscopy. Ms. Curtis had previously agreed that if this procedure had shown anything irregular, the doctor could go in, check it out and take care of whatever problem existed on the condition that her reproductive capability not be removed. As it turned out, upon accomplishment of the procedure, the doctor discovered that Ms. Curtis had substantial internal scar tissue in her pelvic area which had attached itself to her bladder, tubes, ovaries, intestines, interior of the "belly" and other internal and pelvic areas. This creates almost debilitating, constant pain as scar tissue develops, which increases as the scarring advances. Movement makes it worse--even the simple movements of walking, turning, etc. Even when the scar tissue is removed, it comes back unless there is a hysterectomy. Contra to this theory is the testimony of the Petitioner's expert, Dr. Lewis, who opined that movement not of the individual, but of the organ, would create pain. This difference in opinion is not particularly significant, however, as it is hard to conceive how movement by an individual, unless undertaken with an extremely delicate step, would not result in movement of the organs. In any case, since Dr. Lewis did not examine the patient, was not familiar with her nature, her makeup, or her disposition, it is more logical to assume that the physician who treated her over an extended period of time would be more acquainted with her condition and with the results of her activities than would one who sits in his office examining merely records. In this case, therefore, the observations and opinions of Respondent, who treated the patient, who performed the surgery and who was familiar with the individual, prevail. It is also pertinent to note here that Ms. Curtis, at the time this situation was going on, had met a man she intended to marry and bear children for. As a result, she did not agree to have the needed hysterectomy that was the only procedure that would cure the problem and remove the pain, at least until such time as she conceived and bore this man a child. Therefore, under those circumstances, in the opinion of the Respondent, Percodan was appropriate. Even though they are frequent and repeated, in his opinion, in light of her circumstances, her mental, physical, emotional and situational needs, this regimen was called for. While the Physician's Desk Reference indicates the standard dosage of Percodan as one every six hours, it also provides that this dosage can legitimately and should be exceeded when the situation calls for it. It is pertinent, also, to note here that Ms. Curtis at this time was traveling with her intended husband, a truck driver, in his truck, a situation which created more pain than would normally be experienced, and because of that could not come into the doctor's office as often as necessary. Therefore, in light of the fact that she would not agree to the only procedure that would alleviate her pain, the hysterectomy, and insisted on traveling with her putative husband, it was imperative that she receive relief from the pain, and Percodan was the only thing that would do it. Dr. Lieberman also treated a Julie Londy, first on August 18, 1980, when she came to see him, complaining of chronic pelvic pain, chronic bleeding from the vagina and painful periods. This lady was married, wanted no children and desired a hysterectomy. She entered the hospital for that procedure on April 22, 1980, and had a total abdominal hysterectomy plus an appendectomy on April 24, 1980. She was discharged on May 3, 1980. The conjunction of two major surgical procedures may have increased her pain, and her pain may have carried over from the previous condition she was experiencing, thereby reducing her tolerance for pain. Dr. Lieberman prescribed Tylox on three separate days within a six-day period, May 3, 7 and 9, 1980. Tylox is a Class II drug which is indicated for the reduction of pain. The generally accepted dosage is one every six hours, except in extreme discomfort, when the dosage can be increased. In this case, Ms. Londy was experiencing great pain because, coincident with her recuperation from the hysterectomy and appendectomy, she was experiencing a bladder infection; and, since she is allergic to codeine, Demerol, Dilaudid and aspirin and had told Respondent that Tylox was the only medication that would relieve her pain to which she was not allergic, he prescribed that substance. The first prescription was given on May 3, 1980, the day of her discharge from the hospital, and consisted of 40 pills. That should have lasted for ten days at the normal rate. The second prescription, for 30 pills, was given four days later because she was experiencing great discomfort. The third prescription, for 40 more, was administered on May 9, 1980, at her regular follow-up visit, after which the doctor was not to see her again for at least a month. It was his intention, by prescribing so many pills at one time, to give her a restful postoperative recovery; and the large number of pills was an advance. As a matter of fact, after May 9, the doctor did not see her again until late June 1980, some six weeks after the date of the last prescription. At that time, she was experiencing no pain, and neither asked for nor received additional narcotics. Respondent first saw Marilyn Quantrill on February 1, 1977. At that time, the patient, a 21-year-old female, was in early stages of pregnancy and wanted an abortion. This procedure was accomplished on February 7, 1977. Shortly thereafter, she got pregnant again and, despite the fact that she was being beaten by her husband, she decided to have the baby and did. Her husband continued to beat and emotionally abuse her (threats to take the child) to the point that she was a "nervous wreck." When she came to see Dr. Lieberman for the Seconal on July 17, 1978, her condition was such that she could not sleep because of her relationship with her husband, and Respondent gave her the Seconal to help her sleep. She was experiencing difficulty in coping with stress, and this condition is made worse by lack of sleep. She needed to sleep, and he gave her the pills in question to help her sleep. He thought his prescription for one pill per day at night for sleep was appropriate. The total number of Quaaludes prescribed over the five-month period was 210 pills. The period in question accounted for approximately 163 days. This is slightly over one pill per day, not notably excessive. It is also noted that Dr. Lieberman initially prescribed Seconal, thereafter switching to Quaaludes. He discontinued the Seconal because it was not strong enough to provide the necessary effect in light of her situation. It is also noted that Ms. Quantrill's husband was reported to be a drug dealer. When Dr. Lieberman found out this was the case, he not only stopped providing drugs for Ms. Quantrill, he declined to take her as a patient any longer. In the case of patient Stormy Druga (Smith) who received a drug called Eskatrol on three different occasions for weight loss, the allegation is not that the doctor prescribed improper amounts of the drug, but that the drug was prescribed for a purpose not permitted under Florida Statutes. Dr. Lieberman admits prescribing the drug on the date set out and the amount. He had used this drug for this patient before because she was overweight. She had just had a hysterectomy, was getting a divorce and desperately wanted to lose weight to improve her appearance. The prior use was successful in that she lost 30 pounds. Though Dr. Lieberman subscribed to numerous publications, he did not know that Florida had changed the law, prohibiting the use of Eskatrol for diet purposes. During the period in question, from August through November 1980, Ms. Druga came in every month for a weight control regimen, and he prescribed 30 pills each visit for a total of three visits. Unknown to him, the Florida Legislature had recently changed the law, prohibiting the use of any amphetamines or sympathomimetic amine drug or a compound designated as a Schedule II controlled substance, except for certain conditions of which weight control is not one. The first notice that Dr. Lieberman had that the law was changed was a bulletin issued by the Department of Professional Regulation in February 1981, three months after he stopped the prescription. In that regard, Dr. Lewis, the Petitioner's witness, stated that according to his experience, a doctor becomes aware of a change in one of several ways: (1) drug company flier, (2) a pharmacist's comment, and (3) national subscription-type letters. However, the State does not normally send out any bulletins regarding changes at the time the change is considered or initially made. Under these circumstances, it is quite likely that Respondent was not aware of the fact that the law had changed, prohibiting the use of Eskatrol for weight control purposes, during the time he prescribed it for Ms. Druga, as alleged. Each allegation against Respondent was evaluated by an expert in the field of obstetrics/gynecology for both Petitioner and Respondent. Petitioner's expert, Dr. Lewis, concluded, with regard to Ms. Rousseau, at least, that Respondent's charting is weak; he did not indicate on the record if the patient was seen on any of the visits which resulted in the issuance of a prescription and that Percodan, in this case, was prescribed without any clinical entry of observations on the records. On the other hand, Respondent's expert, Dr. Harry J. Stone, concluded that Percodan was appropriate in both the substance and the amount prescribed for Ms. Rousseau, a total of approximately 320 capsules over a two-plus-year period. If, as was claimed by Dr. Lewis, none of the prescriptions are charted, even that does not constitute malpractice because, according to Dr. Stone, in the practice of obstetrics end gynecology, quite often medications are not charted when the doctor is called out on an emergency situation before he can put it on the chart. As to Ms. Druga, Dr. Lewis indicated that Eskatrol was withdrawn from market use for weight control in 1980 because so much got into the Black Market and because of the undesirable side effects of amphetamines. The records examined by the doctor, which cover a period of time not alleged in the Administrative Complaint, show that over a period consisting of one year, five months and 21 days, Ms. Druga received 480 capsules and diuretics with a total weight loss of 10 pounds. While this is not successful weight loss maintenance, it is nonetheless not unusual depending upon the individual. Dr. Stone, himself, did not know of the change in the law regarding Eskatrol when it went into effect on July 1, 1980, and in his opinion, knowledge of this change within the medical community was poor. Both experts are in agreement that the State does not notify doctors of the changes, as the federal government does. The notices generally go to the pharmacists and, as a courtesy, the pharmacist should have called the Respondent, especially since the prescription here clearly stated it was for diet control. There is no question that prescriptions were issued for Eskatrol by Dr. Lieberman at a time when the law had been changed to prohibit the use of that drug for weight control purposes. It is equally clear, however, that Dr. Lieberman was unaware of the change and that insufficient effort was made by the State at the time to provide knowledge of the change to the various physicians. Turning to Ms. Quantrill, Dr. Lewis feels that because the patient came in and requested Valium and thereafter, as indicated in her letter to the Respondent, took 30 milligrams at one time, which is an excessive dose, Respondent should have suspected that she was likely to abuse drugs. She received prescriptions for 210 Quaalude capsules within a 163-day period. Dr. Stone, on the other hand, opined that the amounts in question were justified based on the emotional strain the patient was undergoing, as well as the pain from her condition. As to Ms. Creed, Dr. Lewis feels that when a patient asks for a particular Class II drug, that is characteristic of an addict, and he does not believe that Dilaudid was called for when Respondent administered it. On the other hand, Dr. Stone, based on the medical records he reviewed, including patient's case history, feels that under the circumstances of the first visit, the prescription of Dilaudid was appropriate in both substance and amount because of the acute pain associated with chronic pelvic disease. The antibiotics that were prescribed by Dr. Lieberman to cure this condition take a long time to work, and the patient needs help to stand the pain. If Dilaudid had worked in the past, it was not inappropriate to use it again. As to the second visit when Ms. Creed got Dilaudid, Dr. Stone feels that again the drug and the amounts prescribed were appropriate for much the same reasons. As to Ms. Boudreaux, Dr. Lewis feels that Respondent's records do not show any complications, and he feels that the drugs prescribed were too much in quantity for an uncomplicated postoperative course. It should be noted here, as elsewhere, that Dr. Lewis, in examining Dr. Lieberman's records, is at times very critical of them as being not complete enough, but at other times relies on them to support his viewpoint. For example, the witness uses the number of pills listed in the record to support the conclusion of over prescription without knowing the patient or having seen her, but when asked if the records say that Respondent stopped prescribing the drugs, this same witness states, "But we don't know what transpired because it's not in the record of what he saw the patient about, whether a medical problem or a drug problem." Dr. Stone, on the other hand, is of the opinion that the prescription of Percodan for Ms. Boudreaux was appropriate because of the combination of the two operations., the insertion of a painful catheter for a long period (six days) , the infection (which was painful) and the nerve injury (very painful). Because of the second hospitalization for the infection in September, Dr. Stone feels that the Percodan prescribed in September and October was appropriate. There does not appear to be an opinion from Dr. Lewis on the treatment given to Ms. Curtis. Dr. Stone, however, opines that the Percodan prescribed by Respondent for this patient from March to July 1979, was justified because of the repeated surgery. A second operation in the same area as former surgery is very painful. This drug can be given and was given at a prescribed rate of one every four hours as necessary for pain. In the opinion of Dr. Stone, this is reasonable, even though the Physician's Desk Reference calls for administration of one every six hours. In addition, continued use, which admittedly this patient had done, develops a tolerance which can result in raised usage. Therefore, even though Dr. Lieberman prescribed 830 pills over 121 days, a rate of almost seven a day, while higher than normal, this is not so aberrant a prescription rate under these circumstances as to be considered necessarily inappropriate or constitute substandard practice. Dr. Lewis also did not give an opinion as to Ms. Londy, for whom Tylox was prescribed. Dr. Stone, on the other hand, felt that the use of Tylox in the amounts prescribed was justified. Here, the patient had undergone major surgery, including an appendectomy, had had implanted a drain and had developed a fever, which indicates infection, with swelling and pain. All of these conditions justify the use of the drug in the amounts. Though the total quantity may seem high, it should be noted, however, this was only for a short period, and the pain of all the surgery and the patient's condition under these circumstances rendered this prescription in this amount not necessarily inappropriate. Based on his overall evaluation of the various patient records and his knowledge of Dr. Lieberman gained from observing him on staff at Florida Hospital and Respondent's excellent reputation as a gynecological and obstetrical surgeon in his community, he is satisfied there has been no gross or repeated malpractice in what Dr. Lieberman has done. Further, his review of the records reveals no indication of fraud, trickery, or any of the other alleged deceptive representations or any indication of bad faith on the part of the Respondent. Petitioner offered no evidence of these latter characteristics. Turning to the issue of medical stockpiling, however, Dr. Stone is quick to admit and recognize that the stockpiling of medicines as was done here in some cases by this Respondent is not a good idea. However, in the world as it exists, it may in some cases, and he is of the opinion that it was in the cases here, be acceptable practice, and not malpractice. Respondent, who has treated approximately 10,000 patients since he entered medical practice in 1976, routinely prescribes controlled substances in his practice. When he does so, he uses a high degree of care because of the addictive nature of Class II drugs. Before prescribing, he considers the individual and their medical problem needs. Modern OB/GYN practice allows physicians in these specialties to serve as "full" physicians to women, and they can treat their patients for illnesses other than those related to the OB/GYN practice. Under this situation, the doctor is required to also consider the emotional, physical, psychological and socioeconomic needs of his patients. It is wrong to merely consider records. A doctor treats people.
Recommendation On the basis of the above, it is, therefore, RECOMMENDED: That the Administrative Complaint against Respondent, Robert A. Lieberman, M.D., be dismissed and no disciplinary action be taken against him on the basis of the activity alleged in this Administrative Complaint. RECOMMENDED this 31st day of January 1984, in Tallahassee, Florida. ARNOLD H . POLLOCK 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 31st day of January 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Herbert M. Hill, Esquire Thomas Michael Burke, Esquire Post Office Box 1873 Orlando, Florida 32802 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact On June 27, 1991, Petitioner applied for licensure in the State of Florida by endorsement as a physician. He is presently licensed in the states of Alabama, Louisiana and Wisconsin. He is board eligible in dermatology and is currently a house physician for New Orleans General Hospital in New Orleans, Louisiana. On January 5, 1993, Respondent denied Petitioner's Florida application because of Petitioner's previous history of psychiatric problems and psychotherapy which affected his ability to practice medicine with skill and safety; his current psychiatric and psychological evaluations indicating an obsessive-compulsive disorder which could affect his abilities to practice with skill and safety; and the prior denial of his licensure application in 1987 as the result of material misrepresentations in the application. On three separate occasions, Petitioner has applied for licensure in Florida. In addition to the current application, he applied on April 4, 1986 and on August 2, 1990. Following a formal hearing, the 1986 application was denied on December 22, 1987, as the result of misrepresentation in the application. An application for admission filed in 1990 was subsequently not timely completed and became void. All of Petitioner's applications and materials submitted with regard to those applications are maintained by Respondent in one file, a normal practice for Respondent. Documents in that application file have been generated by Respondent or supplied by Petitioner. Diagnosed in 1977 with an obsessive-compulsive disorder, obsessive- compulsive personality and dysthymia, Petitioner has been receiving treatment for his mental illness since 1979. He was hospitalized for a psychotic episode in 1987. From 1988 until the present, Petitioner has been taking Sinequan and Mellaril. The daily dosage of 50 milligrams of Mellaril has not varied during that time period. The daily dosage of Sinequan initially was 150 milligrams per day, tapered to 40 milligrams each night at present. About three months ago, Petitioner began taking about a gram of Valproic acid each night. These medications have a sedating or hangover effect on Petitioner in the morning. At one point in 1992, Petitioner temporarily switched to another drug, Anaframil, for a month to a month and a half. One of the reasons for the switch was that Petitioner was going to be reevaluated by a psychiatric expert, Dr. Dohn, at Respondent's request. Dr. Dohn's previous evaluation had expressed concerns about possible effects on Petitioner's clinical abilities as a result of medication side effects. After Dohn's second evaluation of Petitioner, Dohn was much more confident of Petitioner's abilities in view of the then change to Anaframil for treatment of Petitioner's obsessive-compulsive disorder. Mellaril and Valproic acid are psychotropic medications which have confusion as a side effect. Sinequan can have confusion and sedation as a side effect. Valproic acid also has a sedating effect. The dosage of these medications as taken by Petitioner are sufficient to produce these side effects. The effects of the medications carry over to the following day, although taken the evening before. Psychological evaluations of Petitioner dated October 7, 1991 and August 28, 1992, reflect that Petitioner's cognitive abilities have been affected by his mental condition, inclusive of the medications he takes. The 1991 evaluation documents Petitioner's difficulties with recall of verbal instructions and numbers presented verbally to him; completing eye-hand coordination tasks within the maximum time limit; distinguishing visual details; and a tendency to become stymied with anxiety. Further, the 1992 report indicates that certain symptoms of Petitioner's obsessive-compulsive disorder could conceivably interfere with his ability to perform surgery. The 1992 report was done following testing of Petitioner after his brief change to the drug, Anaframil. Following Petitioner's 1992 evaluation by Dr. Dohn, conducted in close proximity to the August 1992 psychological evaluations, Petitioner quit taking Anaframil and resumed his previous medications of Mellaril and Sinequan. At deposition following a recent psychiatric evaluation of Petitioner by Dr. Edward Foulks, Foulks opined that Petitioner's illness should not be a barrier to the practice of medicine. Foulks opinion is not credited in view of his lack of independent knowledge of Petitioner's medications or mental condition; his lack of knowledge of whether Petitioner's condition had stabilized; how the condition had been resolved; or how much further treatment Petitioner would likely require. Foulks' opinions were based in large part upon Petitioner's representations to him. Petitioner's evaluations from Lazarus S. Gerald of the University of Pennsylvania Department of Dermatology, dated August 21, 1990 and July 8, 1991; from the chief of the Dermatology Department of Lloyd Noland Hospital and Clinic in Fairfield, Alabama, dated August 21, 1990; and from Dr. Derek J. Cripps, Director of the Department of Dermatology of the University Station Clinics, University of Wisconsin, note Petitioner's psychiatric condition as a possible explanation for performance difficulties. In 1986, Petitioner made numerous misrepresentations in his application for licensure. He answered "no" to the application question of whether he had a mental or emotional illness, although he had been ill since 1977 and had been treated from 1979 until 1986 by several psychiatrists. He also answered "no" to whether he had received psychotherapy. He was suspended from seeing patients during the last three months of residency at the University of Wisconsin, but answered "no" to the question of whether he had ever ceased practice for more than a month. He also answered "no" to the question of whether he had ever been denied hospital privileges or had such privileges acted against. In his August 2, 1990 application, Petitioner again answered "no" to whether he had been denied hospital privileges or had his hospital privileges acted against. Later, recognizing that this was not an accurate representation, Petitioner forwarded an affidavit, dated May 16, 1991. In that affidavit, Petitioner changed his answer to "yes". While only receiving partial credit of three months for his residency at the University of Wisconsin, Petitioner listed the dates on the form so that it appeared that he had received one year's credit. In his current application, dated June 27, 1991, Petitioner again failed to show that he only received partial credit for his residency at the University of Wisconsin. An affidavit dated November 21, 1991, was submitted by him regarding the residency program at Tulane University in which he was then participating. The affidavit failed to indicate that his participation in the residency program was conditioned upon his being in the impaired residents program and that the residency lasted 18 months, although he needed only six months to complete residency requirements for the dermatology board examination. Petitioner also failed to tell his supervising physician at Tulane, Dr. Shrum, of Petitioner's previous application for licensure in Florida or denial of that application for licensure, until after Shrum had been deposed regarding Petitioner's reputation for truthfulness.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying the application for licensure by endorsement. DONE AND ENTERED this 10th day of December, 1993, in Tallahassee, Leon County, Florida. DON W. DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of December, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-1671 The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-2. Accepted. Rejected, weight of the evidence. Rejected, cumulative. Subordinate to HO findings. Accepted. Subordinate to HO findings. 8.-13. Accepted, but not verbatim. 14. Rejected, credibility. 15.-20. Rejected, unnecessary. 21.-25. Subordinate to HO findings. 26. Rejected, credibility. 27.-38. Rejected, credibility. 39.-45. Rejected, credibility. 46.-51. Rejected, subordinate to HO findings. 52. Rejected, relevancy. 53.-59. Rejected, credibility. Respondent's Proposed Findings. 1.-13. Accepted, but not verbatim. COPIES FURNISHED: Claire D. Dryfuss, Esquire Department of Legal Affairs The Capitol, PL-01 Tallahassee, Florida 32399-1050 Steven W. Huss, Esquire 1017-C Thomasville Road Tallahassee, Florida 32303 Jack McRay General Counsel Department of Business and Professional Regulation The Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Board of Medicine Department of Business and Professional Regulation The Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
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
Findings Of Fact On or about March 15, 1990, A.J.F., an 86 year old white male went to the office of Respondent for the purpose of getting an eye examination and new glasses. A.J.F. had lens implants in both eyes in 1984 and had some astigmatism. Respondent examined A.J.F. and prepared a prescription for new glasses for A.J.F. The glasses were made by Disston Optical, a company independent of Respondent, but located in the same building as Respondent's office. A.J.F. picked up his glasses a week or two after his prescription was written and started home with them. After driving with the new glasses for about five minutes, A.J.F. concluded that he could not see well through the right lens of the glasses and replaced them with his old glasses. Later that evening, A.J.F. tried to read with his new glasses and again found he could not see well through the right lens. Within 24 hours of picking up these new glasses, A.J.F. returned to Respondent's office with the glasses complaining that he couldn't see well through the right lens. Respondent told A.J.F. that he should wear the glasses for a week or two before deciding they were unacceptable. A.J.F. demurred, and Respondent took the glasses from A.J.F. and walked into the back of his office. Respondent made no offer to check the glasses or reexamine A.J.F. Earlier A.J.F. had problems with glasses prescribed by another optometrist and complained to the optometrist who put the glasses in A.J.F.'s pocket. Although A.J.F. wrote a letter to Medicare not to pay for the unsatisfactory glasses, he found they did pay because he had taken the glasses. A.J.F. did not intend to repeat that mistake. Following Respondent's refusal to do anything about A.J.F.'s glasses, A.J.F. complained to the Department of Professional Regulation and sent a letter to a Channel 8 TV ombudsman (8 on your side) complaining of Respondent and optometrists in general. The complaint of A.J.F. was investigated by Petitioner which investigation included A.J.F.'s medical records from Respondent and from an ophthalmologist previously seen by A.J.F. and also seen by the ophthalmologist subsequent to having been seen by Respondent. These records show that Respondent's prescription for the right eye of A.J.F. contained an axis of 45 degrees for the astigmatism adjustment while prior examinations contained an axis of 85 to 95 degrees for this same adjustment. Following his failure to obtain satisfactory glasses from Respondent, A.J.F. went to the ophthalmologist he had previously seen, Dr. Don B. Knapp, II, M.D., to obtain glasses. Dr. Knapp's examination on June 7, 1990 (Exhibit 2) determined the astigmatism field adjustment was 85 degrees for the right eye. The axis for the astigmatism in A.J.F.'s right eye of 90-95 degrees in earlier examinations, a 45 degree axis in Respondent's examination, and an 85 degree axis in Dr. Knott's examination a couple of months after Respondent's examination constitutes a significant change which would indicate a distinct possibility exists that the axis determined by Respondent was inaccurate. The fact that there was approximately a 45 degree change in this axis between A.J.F.'s earlier examination and the examination conducted by Respondent should have alerted Respondent that his examination could have been in error when A.J.F. returned with the glasses complaining that he could not see clearly through the right lens. An error of that magnitude could very well lead to the patient being unable to see through the glasses. By failing to conduct a further examination of A.J.F. or to check the lens to see if it was made in accordance with the prescription he issued, Respondent was negligent in the practice of optometry. It is also clear that A.J.F. has a history of complaining about new glasses that are prescribed for him, and he can be characterized as a difficult patient. By Final Order entered June 22, 1989, Dr. Klugman was found guilty of violating Section 463.016(1)(g)(negligence of the practice of optometry) and Section 463.016(1)(h)(violation of Rule 21Q-3007, Florida Administrative Code), was fined $1,500, and his license was placed on probation for 12 months. By Final Order entered March 14, 1991, based upon a Stipulation, Respondent was ordered to pay a civil judgment entered against him in Hillsborough County Court in the amount of $177 and to refrain from violating Chapters 455 and 463, Florida Statutes.
Recommendation It is recommended that a Final Order be entered finding Mark L. Klugman, O.D., guilty of violating Section 463.016(1)(g), Florida Statutes, assessing an administrative fine of $2,000, suspension of his license for three months, and placing Mark L. Klugman's license on probation for a period of 12 months under such terms and conditions as the Board of Optometry deems appropriate. ENTERED this 7th day of October, 1991, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of October, 1991. APPENDIX Proposed findings submitted by Petitioner are accepted, except for finding 9. While a licensee on probation would be expected to be more careful than one not on probation, there is no legal requirement that the probationee exercise a higher standard of care than a licensee not on probation. Respondent's proposed findings are accepted, except for: Finding 3 - No evidence was submitted that Respondent verified the accuracy of the spectacles or that A.J.F. returned the spectacles to Disston Optical. Finding 4 - Last sentence rejected. No evidence was submitted that A.J.F. returned the spectacles to Disston Optical. COPIES FURNISHED TO: Laura P. Gaffney, Esquire Department of Professional Regulation 1940 N. Monroe Street Suite 60 Tallahassee, FL 32399-0792 Mark L. Klugman 4201 49th Street North No. 202 St. Petersburg, FL 33709 Patricia Guilford Executive Director Board of Optometry Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay General Counsel Department of Professional Regulation, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issues in this case are: whether Respondent, Tallahassee Facility Operations, LLC, d/b/a Consulate Health Care of Tallahassee (“Consulate”), committed a Class III deficiency at the time of a complaint survey conducted on July 2, 2013; whether Consulate committed two further Class III deficiencies at a revisit survey on August 12, 2013; and, if Consulate did commit the alleged Class III deficiencies found during the surveys on July 2 and August 12, 2013, whether the latter deficiencies constituted “uncorrected deficiencies” meriting the imposition of a $1,000 fine and the issuance of a conditional license to Consulate for the period August 13, 2013 through September 30, 2014.
Findings Of Fact AHCA is the state agency charged with licensing of nursing homes in Florida under section 400.021(2), Florida Statutes, and the assignment of a licensure status pursuant to section 400.23(7), Florida Statutes.1/ AHCA is charged with evaluating nursing home facilities to determine their degree of compliance with established rules as a basis for making the required licensure assignment. Pursuant to section 400.23(8), AHCA must classify deficiencies according to their nature and scope when the criteria established under section 400.23(2) are not met. The classification of the deficiencies determines whether the licensure status of a nursing home is "standard" or "conditional" and the amount of the administrative fine that may be imposed, if any. During the survey of a facility, if violations of regulations are found, the violations are noted on the prescribed form and referred to as "Tags." A tag identifies the applicable regulatory standard that the surveyors believe has been violated, provides a summary of the violation, and sets forth specific factual allegations that the surveyors believe support the violation. Consulate operates a 120-bed nursing home at 1650 Phillips Road in Tallahassee and is licensed as a skilled nursing facility. July 2, 2013, complaint survey Having received c omplaints alleging Consulate’s failure to follow physician-ordered plans of care for residents, AHCA sent a survey team to conduct a survey of the facility on July 2, 2013. Registered nurse specialist surveyor Susan Page was specifically directed to examine the facility’s procedures regarding activities of daily living (“ADLs”) and its practices in following physicians’ plans of care. Ms. Page reviewed the records of Resident 1, a male resident who had suffered a fractured pelvis in a fall at his home. He had been fitted with an external fixation device to stabilize the fracture and was admitted to Consulate for rehabilitative care. The external fixation device was anchored by metal pins that were inserted through the skin and into the bone. When the fixator was removed, a small wound remained at the pin site on Resident 1’s hip. Resident 1 had been discharged on June 27, 2013. Ms. Page’s review was thus limited to the facility’s records. She looked at the generalized history of the resident, the physician orders, the grievance log, the ADL treatment record, care plan, and the Minimum Data Set information on Resident 1. Ms. Page discovered a written physician order dated June 1, 2013, that directed Consulate staff to clean the pin site with Betadine then wash off the Betadine and cover the wound with gauze twice a day for seven days, and afterwards to wash the wound with soap and cover it daily. The order directed a ten-day course of Zyvox, an antibiotic. Finally, the physician order stated, “Make sure [patient] showers daily.” Ms. Page testified that she reviewed other physician orders that showed changes in pain medications and indicated that Resident 1 was having issues with loose stool or diarrhea. He was tested for the bacterium Claustridium difficile (“C. diff”) in his stool. Ms. Page reviewed Consulate’s ADL Flow Record for Resident 1 and discovered that during the period from June 1 to June 27, the resident was given a shower on only seven days, despite the physician’s order that he receive a daily shower. On four days during that period, Resident 1 received no form of body cleansing. On the remaining days, he was given bed baths. Ms. Page and Debra Ball, a registered nurse specialist who was part of the survey team, each testified that a bed bath is not commensurate with a shower. A shower involves clean water running over the entire body, allowing the body to be cleansed with soap and rinsed with clean water. A bed bath involves a tub of soapy water and a tub of clean water. The resident remains in the bed and the staff person wipes the resident off as best she can. The resident is not immersed in clean water. Ms. Page explained the significance of Consulate’s failure to follow physician orders for Resident 1. The resident’s recent surgery provided a portal of entry for bacteria into the body, and the physician’s orders were designed to work in combination to minimize the possibility of infection. The daily shower was an essential part of the physician’s plan of care for Resident 1. A shower is invaluable in keeping low the bacteria count on the resident’s skin. The shower was especially important in this situation because of the pin site location on Resident 1’s hip and his noted problems with loose stools and possible C. diff infection. Ms. Page, opining as an expert in nursing, testified that the failure to follow the physician order in this case potentially compromised Resident 1’s ability to maintain or reach his highest practical mental, physical, or psychosocial well-being. Ms. Page specifically testified that due to the position of the wound site, the loose stools, and the fact that the portal of entry led directly to the bone, Resident 1 had a potential to contract cellulitis or osteomyelitis as a result of the deficiency. Ms. Page conceded the efficacy of cleansing with Betadine, but noted that the antibacterial cleansing was prescribed for only seven days and that the failure to give showers as prescribed occurred on consecutive days after the Betadine prescription had expired. As a result of the failure to provide showers or to note in the record any reason for that failure, the facility was cited for violating Florida Administrative Code rule 59A- 4.107(5), which provides: “All physician orders shall be followed as prescribed, and if not followed, the reason shall be recorded on the resident’s medical record during that shift.”2/ The deficiency tag correlating to this violation is Tag N054. Consulate was cited with a Class III deficiency for this violation. Ms. Page testified that the decision to classify the July 2, 2013, deficiency as Class III was reached by a consensus of the four-person survey team, all registered nurses, and was based on the facts of the case and the statutory definition set forth in section 400.23(8)(c): A class III deficiency is a deficiency that the agency determines will result in no more than minimal physical, mental, or psychosocial discomfort to the resident or has the potential to compromise the resident’s ability to maintain or reach his or her highest practical physical, mental, or psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. Ms. Ball agreed that Consulate should be cited for violating rule 59A-4.107(5) and that the violation should be classified as Class III. Ms. Ball testified that in her experience it is not unusual for a physician to direct the manner in which the cleansing of a post-operative patient should occur. She noted that the pin site’s portal of entry went into the bone and that bone infections have high morbidity and mortality rates. Ms. Ball further noted the variety of infections that could occur in a case such as Resident 1’s: osteomyelitis, enterococcus, candida, methicillin-resistant staphylococcus aureus (“MRSA”), and the most common one, staphylococcus. Some of these infections could be life threatening. Ms. Ball, who was accepted as an expert in nursing, offered the opinion that the failure to follow the physician order for showers had the potential to cause a surgical site infection, which in turn had the potential to compromise Resident 1’s ability to maintain or achieve his highest practical physical well-being. Ms. Ball testified that an infection is never the sort of “minor impact” contemplated by the statutory definition of a Class IV deficiency. Ms. Ball testified that each of the four registered nurses on the survey team agreed that the failure to follow physician orders had the potential to compromise Resident 1’s health and that the violation should be classified as Class III. Patricia McIntire is a registered nurse consultant supervisor for AHCA. Her duties include reviewing cited deficiencies and ensuring that the evidence cited by the survey teams meets the requirements of the applicable statutes and regulations. Ms. McIntire was the supervisor who reviewed the July 2, 2013, survey file. She agreed that the cited deficiency should be classified as a Class III deficiency. AHCA’s citation gave Consulate until August 2, 2013, to correct the deficiencies noted in the survey. August 12, 2013 revisit survey Ms. Ball was sent to conduct a revisit survey of Consulate on August 12, 2013 in order to determine whether the previous deficiencies had been corrected. Ms. Ball was specifically looking for Consulate’s compliance with physician orders and the correction of the federal citation related to ADLs. Ms. Ball wanted to survey a sample of residents that would include both aspects of the corrections she sought. She knew that residents receiving pain medications would have physician orders for the medications. She therefore asked the facility to provide the records of residents who were receiving both pain medications and assistance with ADLs. Resident 1 and Resident 3 met those criteria. Resident 1, who was not the same person as the Resident 1 cited in the July 2 survey, had a physician order dated July 26, 2013, to change her peripheral inserted central catheter (“PICC”) dressing every seven days starting on August 1. When Ms. Ball checked the PICC dressing on Resident 1, she saw a notation on the dressing indicating that it had last been changed on August 3, nine days prior to the revisit. Ms. Ball testified as to her experience with PICC dressing changes as follows: I’ve done these dressing changes for years. A central line dressing change, we’re not talking about a piece of gauze and a piece of tape. You actually use an adherent Tegaderm dressing. It’s like Saran Wrap. Picture Saran Wrap and when you put it on something, it sticks. Picture Saran Wrap with a sticky surface, a sticky bottom. So you have this clear 4-by-4-inch, it’s a standard size, a clear sticky dressing of Tegaderm. Within your dressing kits— because these dressings have kits that you have to buy. It’s a very involved, long, tedious process to do a dressing change on a PICC. I’ve done several. When you do this dressing change, which isn’t just changing the dressing, it includes a cleaning to disinfect and reduce the number of microorganisms on your skin and then some of them have like a little biofilm. It’s a little patch that you put where the catheter’s going into the vessel. And that biofilm is designed to kind of provide a barrier for seven days. I think that’s probably one of the reasons it’s done every seven days. So you’ve got this clear dressing, this 4-by- 4-inch Saran-Wrap-appearing thing that has a sticky to it. And it’s not easy to peel off. Well, when you change a dressing, within your kit, you also have this little label. It measures about maybe 1-by-2 inches. It says “date” and “initials.” And what you do is when you change that dressing, within your kit, which has a lot of stuff in it, you take the little label after you’ve sealed it, and you put that other sticky label on top of that Saran Wrap type dressing. Well, picture taking a piece of adhesive tape off a piece of Saran Wrap. I challenge you. It can’t be done. It’s going to tear it. So there would be no reason for that dressing to still bear that date of August the 3rd if it had been changed since then. Ms. Ball testified that it is a basic standard-of-care, established by the Centers for Disease Control (“CDC”) and many other entities, that PICC-line dressings should be changed every seven days. Ms. Ball testified that the primary risk associated with failure to change PICC dressings as directed is CLABSI, which is the CDC’s acronym for a central line associated blood infection. She stated that 250 deaths a day are associated with central line associated blood infections. Ms. Ball testified that the potential harm is so great that the CDC has developed initiatives for surgical site infections and central line associated blood infections. Ms. Ball saw the date of August 9 scribbled on a white label stuck to the dressing but she disregarded it because it was not on the label provided in the PICC dressing kit. She spoke to Consulate’s unit manager, who stated that the note on the white label had been made by a Licensed Practical Nurse (“LPN”). The unit manager confirmed that LPNs do not perform PICC dressing changes but nonetheless told Ms. Ball that the dressing must have been changed on August 9. However, the nurse’s notes and other medical records indicated no dates other than August 3 for a PICC-dressing change for Resident 1. Ms. Ball asked Resident 1 when the PICC dressing was last changed but the Resident could not say. Consulate’s medication log confirmed that the dressing had not been changed since August 3. Ms. Ball testified that she looked at the medication record, nurse’s notes, and treatment record and could not find any evidence in any record kept by the facility that the PICC dressing had been changed since August 3. Ms. Ball was also unable to find any evidence that the PICC dressing had been changed from July 26 to August 3, 2013. Ms. Ball concluded that the PICC dressing for Resident 1 had not been changed from August 3 to the date of the revisit survey, August 12, 2013, a period of more than seven days. Ms. Ball also concluded that the PICC dressing had not been changed from July 26 to August 3, 2013, also a period of more than seven days. Consulate’s records gave no reason why the physician order to change the dressing every seven days had not been followed. The physician order required a PICC-dressing change on August 1, 2013. Ms. Ball found no documentation of a PICC- dressing change for Resident 1 on August 1, 2013. After she encountered problems with Resident 1’s treatment, Ms. Ball reviewed the record of Resident 3, who had a physician order dated July 23, 2013, to change her PICC dressing every seven days. Ms. Ball could find no documentation showing that a dressing change occurred from July 23 to August 2, 2013, a period of more than seven days. The facility’s records also gave no indication as to why the dressing change had not occurred. AHCA’s July 2, 2013, notice of deficiency required Consulate to complete all corrections by August 2, 2013. The failures to perform PICC-dressing changes for Residents 1 and 3 occurred on or after August 2, the date by which all corrections were to be completed. On August 12, 2013, Consulate was cited with an uncorrected deficiency for again violating rule 59A-4.107(5), by failing to follow physician orders or to document reasons why the orders were not followed. Ms. Ball testified as to the similarities between the deficient practices found in the July 2 survey and the August 12 revisit survey. In both cases, Residents had orders for specific types of treatment. Both cases involved residents with impaired skin integrity that substantially increased the risk of infection. In both cases, the facility failed to show it was following physician orders. Ms. Ball testified that the July 2 deficiency involved the potential for infection to the bone, a “very complex, very devastating” type of infection. She noted that the August 12 deficiencies involved central lines going directly to the residents’ hearts. She stated, “They both have potential for serious harm or a potential to keep you from getting well or increasing your stay or possibly killing you. Ultimately, you could die from either one.” Ms. Ball testified that in her opinion, Consulate’s failure to follow physician orders for Residents 1 and 3 potentially compromised their ability to maintain or reach their highest practical, mental, or psychological well-being. Ms. Ball testified that AHCA does not assign a specific classification for all deficiencies related to failure to follow physician orders. Each deficiency is assigned a classification based on an application of the statutory definitions to the facts of the specific case under consideration. In this case, Ms. Ball had no doubt that Consulate’s failure to follow physician orders constituted a Class III deficiency. Ms. McIntyre testified that she reviewed the facts related to the August 12, 2013, revisit survey. She agreed that Consulate failed to follow physician orders in accordance with rule 59A-4.107(5), that Consulate’s failures to follow physician orders were properly classified as Class III deficiencies, and that they constituted an uncorrected deficiency from the July 2, 2013, complaint survey. The plan of correction Section 400.23(8)(c) provides in part: “A citation for a class III deficiency must specify the time within which the deficiency is required to be corrected. If a class III deficiency is corrected within the time specified, a civil penalty may not be imposed.” Section 408.811(4) provides that a deficiency must be corrected within 30 calendar days after the provider is notified of inspection results unless an alternative timeframe is required or approved by the agency. Section 408.811(5) provides: “The agency may require an applicant or licensee to submit a plan of correction for deficiencies. If required, the plan of correction must be filed with the agency within 10 calendar days after notification unless an alternative timeframe is required.” After the July 2, 2013, complaint survey, AHCA sent to Consulate a letter dated July 12, 2013, stating that “Deficiencies must be corrected no later than August 2, 2013,” and requiring Consulate to file a plan of correction within ten days. The letter provided that the plan must contain the following: What corrective action(s) will be accomplished for those residents found to have been affected by the deficient practice; How you will identify other residents having potential to be affected by the same deficient practice and what corrective action will be taken; What measures will be put into place or what systematic changes you will make to ensure that the deficient practice does not recur; and, How the corrective action(s) will be monitored to ensure the deficient practice will not recur, i.e., what quality assurance program will be put into place. On July 21, 2013, Consulate submitted a plan of correction that provided as follows as pertains to Tag N054, failure to follow physician orders: Resident #1 has been discharged from the facility on 6/27/2013. An audit has been conducted for current residents shower preferences and an audit has been conducted of current resident ADL sheets. Re-inservice staff on giving showers per shower schedule. Shower sheets will be reviewed 5 times weekly in the clinical meeting for completion. [CNAs] will complete shower sheets daily and the nurse will verify that a shower has been given. Findings will be reviewed at the monthly QA/PI committee meeting to ensure substantial compliance. On July 24, 2013, AHCA sent a fax to Consulate stating that its plan of correction had been approved on June 18, 2003. Barbara Stevens, Consulate’s vice president of clinical services, testified that Consulate completed the corrective work proposed in the plan of correction on or before August 2, 2013. Consulate contends that AHCA’s approval of its plan of correction, without requiring additional conditions or actions, effectively preempts AHCA from finding that the August 12 deficiencies are uncorrected deficiencies from the July 2 survey. AHCA accepted the proposed plan, Consulate performed the plan, and no deficiencies involving showers or other ADLs were a part of the August 12 deficiency findings. In other words, the failure to follow physician orders deficiencies found in the August 12 survey should not be considered “uncorrected” because they were unlike the failure to follow physician orders deficiency found in the July 2 survey. Ms. Ball testified that when AHCA conducts a revisit survey, it is not looking for compliance with a facility’s plan of correction; it is looking for compliance with statutes and regulations. She noted that Tag N054 specifically addresses failure to follow physician orders, not failure to shower a resident. Consulate’s plan entirely neglected to address what it intended to do going forward to assure that physician orders would be followed. She noted that virtually the same plan of correction was submitted for Tag F312, the federal ADL violation, and further noted that it should have been obvious that different actions would be required to correct a failure to provide ADLs and to correct a failure to follow physician orders. Ms. Ball testified that AHCA cannot lead a facility by the nose and tell it how to come into compliance. The facility is expected to know and follow the statutes and rules and to understand what it needs to do to come into compliance. She conceded that nothing in the plan of correction would have prevented the subsequent PICC-dressing violations, but opined that this was a flaw in the plan, not with AHCA’s determination that the PICC-dressing issue constituted an uncorrected deficiency. Consulate “missed the boat” by failing to address physician orders in its plan and paid the price during the August 12 revisit survey. Ms. McIntire testified that Consulate’s plan of correction touched on some of the subjects of its July 2 deficiencies, namely ADLs, but that AHCA expects the facility to correct everything cited in the notice of deficiency. AHCA expected Consulate to look holistically at all physician orders, not merely those related to ADLs. Ms. McIntire testified that when a facility is cited under the physician order tag, the facility will typically look at its entire resident population and establish a mechanism for determining whether staff is following physician orders. The facility is expected to implement whatever corrective actions are necessary to bring it back into compliance, not just for the few residents sampled in the survey but for all of them. It is up to the facility to decide what tool or mechanism it will use to correct the deficient practice. Ms. McIntire testified that AHCA cannot reject a plan of correction on the assumption that the facility did not intend to address physician orders. She stated that AHCA accepted Consulate’s plan because it did address some of the deficient practices that were identified, but that Consulate was nevertheless expected to correct every area in which it was found out of compliance. Ms. McIntire stated that following the plan of correction does not bring the facility into compliance because AHCA surveys for compliance with the regulations, not the plan of correction. Ms. McIntire stated that Consulate’s plan of correction included nothing that would have prevented the deficiency found on August 12 under Tag N054, but that the plan did correct Tag F312. Ms. McIntire testified that the plan of correction is a “jumping off point” for AHCA. The agency wants to see how comprehensively the facility is looking at deficient practices. AHCA proceeds on a good faith assumption that the facility is going to look at all of its residents who could have been affected by the deficient practice and make the proper corrections. Substantial compliance Consulate contended that it should not have been required to file a plan of correction at all because AHCA erred in finding the July 2, Tag N054, deficiency a Class III deficiency. Consulate argues that the deficiency should have been classified as Class IV because it had merely “the potential for causing no more than a minor negative impact on the resident.” Section 400.23(8)(d) provides that no plan of correction is required for an isolated Class IV deficiency. If the July 2 deficiency was Class IV, then the August 12 deficiencies cannot be considered “uncorrected.” Consulate’s argument rests essentially on the proposition that it substantially complied with the June 1, 2013, physician order for Resident 1. The pin site was cleaned with Betadine as prescribed. The wound was cleaned and gauzed as prescribed. The antibiotic was administered. The resident received a bath or shower on all but four days during the period from June 1 to June 27, and on some days he was washed more than once. Consulate argues that AHCA failed to establish how a failure to give Resident 1 a bath and/or shower on four days during the month of June presented a potential for physical, mental, or psychosocial discomfort to the resident or the potential to compromise the resident’s ability to maintain or reach his highest practical physical, mental, or psychosocial well-being.3/ Consulate’s argument is at odds with the evidence. The testimony of AHCA’s witnesses established the potential physical, mental, or psychosocial discomfort to the resident or the potential to compromise the resident’s ability to maintain or reach his highest practical physical, mental, or psychosocial well-being. The potential for infection was real, and the physician’s orders were fashioned to maximize Resident 1’s protection from any potential infection. Further, the deficiency for which Consulate was cited was not one with which it could “substantially” comply. Either the physician orders are followed or they are not. Ms. Page testified that facility staff may not pick and choose which physician orders to follow. The physician did not just pull the order out of the air and instruct Consulate to give the resident a daily shower.4/ It was a prescribed treatment, a preventive measure. Ms. Page observed that all of the prescribed measures were intended to work together to prevent infection. Ms. Ball stated that the order “was obviously infection control related. And he wouldn’t have written an order if he didn’t want it done. That’s why physicians write orders. If they write an order, they expect you to do that, hence, the word ‘order.’” Summary findings Based on the foregoing, it is found that AHCA properly cited Consulate on July 2, 2013 under Tag N054 for violating rule 59A-4.107(5) and properly classified the violation as Class III. Based on the foregoing, it is found that AHCA properly cited Consulate on August 12, 2013 under Tag N054 for two violations of rule 59A-4.107(5) and properly classified the violations as Class III. Further, it is found that AHCA properly cited Consulate for an uncorrected Class III violation for repeated failure to follow physician orders.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order imposing a fine of $1,000 and further imposing conditional licensure on Respondent for the period from August 13, 2013 through September 30, 2014. DONE AND ENTERED this 31st day of December, 2014, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of December, 2014.
The Issue Whether Respondent is guilty of the isolated Class III deficiency alleged in Count II of the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact Respondent is a licensed, skilled nursing home facility located in North Miami, Florida. Respondent was at all times pertinent hereto licensed by Petitioner pursuant to the provisions of Chapter 400 Part II, Florida Statutes. Petitioner is the agency of the State of Florida with the responsibility to regulate skilled nursing homes in Florida. Petitioner surveys nursing home facilities to evaluate their compliance with applicable rules. Petitioner classifies any deficiency noted by a survey according to the nature and scope of the deficiency. The severity of the deficiency determines the amount of any administrative fine and whether the licensure status of the facility should be "standard" or "conditional." A licensee’s failure to comply with an applicable statute or rule is a deficiency. A survey results in a report that lists each deficiency that is found, identifies the applicable regulatory standard that the surveyor believes has been violated, provides a factual basis for the alleged violation, and indicates the scope and severity of the deficiency. A facility is given a deadline to correct each alleged deficiency found during the initial survey. Disciplinary action is typically initiated if a facility has not corrected a deficiency as determined by a follow-up survey. Petitioner conducted a survey of Respondent during the period February 28 - March 3, 2005 (the initial survey). Barbara Catinella, who is a registered nurse and an experienced surveyor, participated in the initial survey on behalf of Petitioner. On March 1, 2005, Ms. Catinella observed perineal care being administered to two female residents (identified as Resident 26 and Resident 27). Each resident was being attended to following an episode of urinary incontinence. The first observation began at approximately 2:00 p.m. and the second began approximately thirty minutes later. Two certified nurses assistants (CNAs) administered the perineal care to Resident 26 and two different CNAs administered the perineal care to Resident 27. In both instances, the CNAs failed to properly perform the perineal care. In each instant, the CNAs performing the perineal care failed to open and clean the labia. At all times pertinent to this proceeding, Respondent had a policy as to perineal care for female residents that conformed to accepted perineal care standards. Paragraph 15 of the policy required Respondent's staff to do the following in sequence for a female resident who had suffered an episode of incontinence, whether the episode was of bowel, bladder, or both: For a female resident: Wet washcloth and apply soap or skin cleansing agent. Wash perineal area, wiping from front to back. Separate labia and was area downward from front to back. Continue to wash the perineum moving outward to and including thighs, alternating from side to side, and using downward strokes. Rinse perineum thoroughly in same direction, using fresh water and a washcloth. Gently dry perineum. Instruct the resident to turn on her side. Rinse wash cloth and apply soap or skin cleansing agent. Wash the rectal area thoroughly, wiping from the base of the labia and extending over the buttocks. Rinse. Dry area. 8. At all times pertinent to this proceeding, Respondent had a policy as to perineal care for male residents that conformed to accepted perineal care standards. Paragraph 16 of the policy required Respondent's staff to do the following in sequence for a male resident who had suffered an episode of incontinence, whether the episode was of bowel, bladder, or both: For a male resident: Wet washcloth and apply soap or skin cleansing agent. Wash perineal area starting with the urethra and working outward. Retract foreskin of the uncircumcised male. Wash and rinse urethral area using a circular motion. Continue to was the perineal area, including the penis, scrotum and inner thighs. Thoroughly rinse perineal area in [the] same order using fresh water and clean washcloth. Gently dry perineum following [the] same sequence. Reposition foreskin of uncircumcised male. Instruct or assist the resident to turn on his side. Rinse washcloth and apply soap or cleansing agent. Wash and rinse the rectal area thoroughly, including the area under the scrotum, the anus, and the buttocks. i. Dry area. The perineal care policy was adopted ". . . to provide cleanliness and comfort to the resident, to prevent infections and skin irritation, and to observe the resident's skin condition." Respondent's staff is trained to adhere to the perineal care policy. The perineal care provided Resident 26 and Resident 27 as observed by Ms. Catinella failed to adhere to Respondent's policy and constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. Respondent argued that the failure to adhere to its policy by failing to spread and cleanse the labia would not cause a urinary tract infection as alleged in the Administrative Complaint. Respondent correctly argues that urine, in the body, is sterile and would not by itself cause a urinary tract infection. Most, but not all, urinary tract infections are caused by the e-coli bacteria found in feces. Respondent established that incontinent residents typically receive perineal care from Respondent's staff 10 times during a 24-hour period. Respondent also established that the facility uses only anti-bacterial soap for perineal care. Based on those considerations, Respondent argued that the perineal care observed by the surveyors may have led to a skin irritation, but that it would not have resulted in a urinary tract infection as alleged in the Administrative Complaint. The greater weight of the credible evidence established clearly and convincingly that the failure to spread and cleanse the labia has the potential for various adverse consequences for the resident, including urinary tract infection.3 If staff does not spread and cleanse the labia, the fact that anti-bacterial soap is being used is irrelevant. If the soap does not reach the labia, that area will not be cleansed, regardless of the number of times perineal care is administered during a typical day. Petitioner established the Class III violations pertaining to perineal care as to the initial survey by the requisite evidentiary standard. Petitioner also established that the violations should be considered "isolated" since there were some 55 incontinent residents in Respondent's facility at the time of the initial survey and only two episodes of improper perineal care were observed. Respondent was provided with a correction date thirty days from the conclusion of the initial survey to correct the noted deficiencies by coming into substantial compliance with accepted perineal care standards. The first follow-up survey occurred April 19-20, 2005. Eleanor Kennedy participated in that follow-up survey and testified, in her deposition, as to three incidents of perineal care that she observed. During the course of the follow-up survey, Ms. Kennedy observed two CNAs administering inappropriate perineal care to a female resident referred to as Resident 15. Ms. Kennedy observed that this resident had suffered an episode of incontinence involving both bowel and bladder. In the course of administering the perineal care, the CNAs failed to open and clean the labia. In addition to observing perineal care to Resident 15, Ms. Kennedy observed perineal care administered to a female resident referred to as Resident 16 and a male resident referred to as Resident and to a male resident referred to as Resident The perineal care administered to Resident 16 and to Resident 17 were inconsistent with Respondent's perineal care policy. The CNAs performing the perineal care for Resident 16 did not follow the proper sequence for cleaning. They first washed the resident's abdominal folds and thigh creases and then opened and washed the labia with the same disposable cloth. Ms. Kennedy testified that the sequence of the cleaning is significant because it risked the transfer of bacteria from the areas first washed to an area that could result in a urinary tract infection. The CNAs who performed the perineal care for Resident 17 first washed the resident's face, underarms, and back. Then, without changing water, the CNAs took a clean cloth and washed the resident's groin area, his retracted foreskin area, and the urinary urethral meatus. The CNAs then dried the resident, but failed to follow the required sequence. As with Resident 16, Ms. Kennedy testified that the incorrect sequence followed by the CNAs risked the transfer of bacteria to an area that could result in a urinary tract infection. Although this sequence clearly violated Respondent's perineal care policy, Respondent established that the potential for urinary tract infection as a result of the sequence was reduced because anti-bacterial soap was used. Ms. Kennedy was uncertain as to whether the use of anti-bacterial soap would alleviate the concerns she had as to the care given these two residents. Because of that uncertainty, it is found that Petitioner did not prove that the perineal care provided Resident 16 and Resident 17 constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. The perineal care provided Resident 15 as observed by Ms. Kennedy failed to adhere to Respondent's policy and constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. On May 26, 2005, Petitioner conducted a second follow- up survey and determined that Respondent was in substantial compliance with applicable regulations.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order adopting the Findings of Facts and Conclusions of Law set forth herein. It is recommended that Count I of the Administrative Complaint be dismissed. It is further RECOMMENDED that Petitioner find Respondent guilty of an isolated, Class III deficiency based on Count II of the Administrative Complaint. It is further RECOMMENDED that Petitioner assess an administrative fine against Respondent in the amount of $1,000.00 for the Class III deficiency found in Count II of the Administrative Complaint and that Petitioner's records reflect that Respondent's licensure was classified "conditional" for the period April 20 - May 19, 2005, and that Respondent's licensure was classified as "standard" before and after those dates. DONE AND ENTERED this 6th day of February, 2006, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 6th day of February, 2006.
