vs. ) Case No. 02-0034
Respondent. )
Robert E. Meale, Administrative Law Judge of the Division of Administrative Hearings, conducted the final hearing in Tallahassee and Key West, Florida, on March 19, 2002.
For Respondent: Karen L. Goldsmith
Goldsmith, Grout & Lewis, P.A. Post Office Box 2011
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.
By Amended Administrative Complaint dated December 7, 2001, Petitioner alleged that on August 12, 2001, Respondent's nurse mistakenly administered to Resident 1 five medications that were prescribed for Resident 1's roommate. The Amended Administrative Complaint alleges that Respondent thus violated Rule 59A-4.112(1), Florida Administrative Code, and Section 483.25(1)(l), Code of Federal Regulations, which require that each resident's drug regime be free from unnecessary drugs, and Rule 59A-4.112(1), Florida Administrative Code, and Section 483.25(m)(2), Code of Federal Regulations, which require that each resident be free from significant medication errors. The Amended Administrative Complaint alleges that Petitioner should therefore issue Respondent a conditional license, pursuant to Section 400.23(7)(b), Florida Statutes.
At the hearing, Petitioner called three witnesses and offered into evidence 11 exhibits: Petitioner Exhibits 1-3, 7-8, 10, 12, 13 (page 36A only), and 16-18. Respondent called five witnesses and offered into evidence no exhibits. All exhibits were admitted.
The court reporter filed the transcript on May 1, 2002.
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.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter. Section 120.57(1), Florida Statutes. (All references to "Sections," unless
explicitly to "Florida Statutes," are to Title 42, Code of Federal Regulations, Section 483.)
Section 400.23(7)(b), Florida Statutes, provides that Petitioner shall issue a conditional license to a nursing home that has any Class I or II deficiencies at the time of an inspection of any Class III deficiencies that are uncorrected at the time of a follow-up inspection. This case raises the question whether the mistaken administration of medications to Resident 1 constituted a Class II violation; if so, Petitioner properly reduced Respondent's license to conditional.
Section 423.8, Florida Statutes, defines Class II, III, and IV deficiencies, in relevant part, as follows:
A class II deficiency is a deficiency that the agency determines has compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. . . .
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. . . .
A class IV deficiency is a deficiency that the agency determines has the potential
for causing no more than a minor negative impact on the resident. . . .
Rule 59A-4.112, Florida Administrative Code, provides the minimum standards for nursing homes. Rule 59A-4.112(1) states: "The facility shall adopt procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident."
More to the point, Section 483.25, which is adopted pursuant to Section 400.23(2)(f), Florida Statutes, and Rule 59A-4.128(1), Florida Administrative Code, details the standard of care for residents of nursing homes:
Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.
Section 483.25(l)(1) addresses unnecessary medications:
Unnecessary drugs--
General. Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:
In excessive dose (including duplicate drug therapy); or
For excessive duration; or
Without adequate monitoring; or
Without adequate indications for its use; or
In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
Any combinations of the reasons above.
Section 483.25(m) addresses medication errors:
Medication Errors--The facility must ensure that--
It is free of medication error rates of five percent or greater; and
Residents are free of any significant medication errors.
Petitioner bears the burden of proving the existence of deficiencies to warrant the imposition of a conditional license. Beverly Enterprises-Florida v. Agency for Health Care Administration, 745 So. 2d 1133 (Fla. 1st DCA 1999).
Section 483.25(l)(1) does not apply to this case because this standard governs the intentional administration of drugs, not an isolated mistaken administration of drugs. Section 483.25(m) governs medication errors. Notwithstanding the fact that a literal application of Section 483.25(l)(1)(i)
could cover the mistaken administration of Norvasc, which was an excessive dose because Resident 1 was prescribed a lesser dose of this drug, the better reading of Section 483.25(l)(1) is not to extend it to medication errors covered by Section 483.25(m).
Section 483.25(m) clearly applies to this case. As implied by Section 483.25(m)(1), a single medication error does not necessarily violate Section 483.25(m). If, as here, the error rate is less than that specified by Section 483.25(m)(1),
then the question is whether the resident who is the subject of a medication error suffered a "significant medication error."
Petitioner has failed to prove that the medication error in which a nurse mistakenly administered four medications and mistakenly administered too much of a fifth medication to Resident 1 was significant. The only likely effect of the medication error was dry mouth from the Clonadine. Even if the hospitalization and intravenous puncture would not have also been required for the exacerbating anemia, which was caused by recent gastrointestinal bleeding, not the medication error, the record does not establish that the resulting discomfort was significant.
At all points after the medication error, the record reveals Resident 1 to be her normal self, not in any discomfort or pain. Just as important, Resident 1's health was never jeopardized by the medication error. Without delay, the nurse detected her mistake, consulted with the nurse practitioner, and hospitalized Resident 1, pursuant to the advice of the nurse practitioner.
Due to the lack of harm to Resident 1, the medication error, even if constituting a violation of Section 483.25(l)(1) or (m), would not constitute a Class II deficiency. The medication error in this case never compromised Resident 1's ability to maintain her highest level of physical, mental, or
psychosocial well-being. The "minimal" discomfort required of a Class III deficiency tolerates a greater level of discomfort than the "minor" discomfort required of a Class IV deficiency.
Nothing in the record suggests that Resident 1 experienced more than such "minimal" discomfort and may not have experienced more than "minor" discomfort.
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
Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2002.
Virginia A. Daire, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive
William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive
Karen L. Goldsmith Alex Finch
Goldsmith, Grout & Lewis, P.A. Post Office Box 2011
15 days from the date of this recommended order. Any exceptions to this recommended order must be filed with the agency that will issue the final order in this case.
