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Based on review of eight orders specified for limited duration (by the prescribing physician) for eight patients, review of the "Order Comments" section of the computerized pharmacy medication profile (CPMP) for each of these orders, and staff interview, the hospital failed to ensure it implemented the plan of correction for the deficient practice found under this regulation from the survey conducted at the hospital during April 2011. During that survey, the surveyor reviewed a patient' s clinical record that had a two day order for a medication that became a 30 day order when the patient changed levels of care and a recapped order set was signed by the physician that did not include the original two day duration on the recapped order for the effected medication. The hospital had developed a plan of correction that was supposed to ensure that limited duration orders would be expressed in terms of number of doses by the physician instead of in terms of number of days of therapy and that the pharmacist would clarify such orders if this had not been done by the physician. Furthermore, the pharmacist was to include the number of doses of the original order as well as the date and time the last dose was to be given in an "Order Comments" box contained in the CPMP. These "comments" would then print out on the the recapped order list printed out by staff when a patient changed levels of care and which the physician would review and indicate if that order was to be continued by checking a "continue" box next to that recapped order. If continued, the order would clearly demonstrate the duration intended by the original prescriber by documenting the original number of doses ordered as well as the date and time the last dose was to be administered.

Out of the eight orders, in two of them (for Patient 2 and 3) the physician did not specify the number of doses and and in four out of four of them (for Patients 2 through 5) the pharmacist did not include the date and time of the last dose to be given in the "Order Comments" box in the CPMP. Furthermore, no evidence was provided that the pharmacist called the prescribing physician to clarify the number of doses for two out of two orders for two patients (Patient 2 and 3) in which the physician did not specify the duration of therapy in terms of number of doses as stipulated in the plan of correction for the previous survey. As a result, when the recapped orders printed out, if the limited duration order were continued by the doctor, it could be continued for longer than originally intended by the prescriber as it would not contain the qualifying time limiting information of the original order.

Findings:

1. On 9/13/11 a review of a copy of an order for Patient 2 in the pharmacy indicated that on 9/10/11 at 12:55 p.m. a physician ordered that Patient 2 was to receive Venofer (an iron preparation) 200 milligrams (mg) intravenously (IV) daily for 5 days. Pharmacist D printed out a screen shot of the order in the CPMP a review of which indicated that the pharmacist had entered "x 5 days" into the "Order Comments" box and Pharmacist D could find no evidence that the pharmacist who entered the order had clarified it with the physician as to the number of doses as stipulated in the plan of correction for the previous survey. Furthermore, the pharmacist had not entered the date and time of administration for the last dose of this medication into the "Order Comments" box.

2. On 9/13/11 a review of a copy of an order for Patient 3 in the pharmacy indicated that on 8/26/11 at 12 p.m. a physician ordered that Patient 3 was to receive Nystatin Powder (an antifungal preparation) twice daily to affected groin and perineal areas topically for 7 days. Pharmacist D printed out a screen shot of the order in the CPMP a review of which indicated that the pharmacist had entered "x7 days" into the "Order Comments" box and Pharmacist D could find no evidence that the pharmacist who entered the order had clarified it with the physician as to the number of doses as stipulated in the plan of correction for the previous survey. Furthermore, the pharmacist had not entered the date and time of administration for the last dose of this medication into the "Order Comments" box.

3. On 9/13/11 a review of a copy of an order for Patient 4 in the pharmacy indicated that on 9/13/11 at 8:30 a.m. a physician ordered that Patient 4 was to receive vitamin K 10 mg subcutaneously daily for 2 days. Pharmacist D printed out a screen shot of the order in the CPMP a review of which indicated that the pharmacist had entered "x 2 doses" into the "Order Comments" box. The pharmacist had not entered the date and time of administration for the last dose of this medication into the "Order Comments" box as stipulated in the plan of correction for the previous survey.

4. On 9/13/11 a review of a copy of an order for Patient 5 in the pharmacy indicated that on 9/12/11 (no time indicated) a physician ordered that Patient 5 was to receive Kefzol (an antibiotic) 1 gram IV every 8 hours for 3 doses. Pharmacist D printed out a screen shot of the order in the CPMP a review of which indicated that the pharmacist had entered "x 3 doses" into the "Order Comments" box. The pharmacist had not entered the date and time of administration for the last dose of this medication into the "Order Comments" box as stipulated in the plan of correction for the previous survey.

On 9/13/11 at 1:08 p.m. Administrative Pharmacist A provided a copy of a memo she had sent to the pharmacy staff dated 8/23/11. A review of that memo at that time indicated it stipulated that that on 8/18/11 the Pharmacy and Therapeutics Committee had determined that physicians were to write for the total number of doses for orders with durations shorter than the automatic stop order policy to prevent miscommunication between the physician and the pharmacist and or nurse. It directed the pharmacist to enter the total number of doses to be given to the patient and the date and time of administration of the last dose of medication in the "Order Comments" box. It directed staff to clarify orders with the physician that did not specify the number of doses in such short duration orders.

Based on staff interview and review of five of ten clinical records of patients who had received intravenous (IV) haloperidol in the three months prior to the survey, the hospital failed to ensure that one of the five patients (Patient 1) received four doses of IV haloperidol while being monitored by an electrocardiogram or ECG (out of a total of ten IV doses received during her hospitalization) which was contrary to published guidelines by nationally recognized organizations and which exposed Patient 1 to the development of torsades de pointes, a potentially fatal arrythmia (abnormal heart beat), in an unmonitored environment.

Findings:

Haloperidol is an antipsychotic medication that is indicated for the treatment of delerium (an acute change in mental status which can be manifested by disorganized thinking, sensory misperceptions, and disorientation to time, place and person) which can be seen in the hosital setting. The intravenous (IV) route of administration of haloperidol has not been approved by the Food and Drug Administration nor has information been provided by the manufacturer on how to administer haloperidol intravenously. One source that addresses the use of IV halperidol is the Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult developed by the American Society of Health System Pharmacists and the American College of Critical Care Medicine of the Society of Critical Care Medicine. These guidelines document that haloperidol can cause a dose-dependent QT interval prolongation leading to an increased risk of potentially fatal ventricular dysrhythmias (abnormal heart beats) including torsades de pointes. The QT interval is seen on the ECG of the heart and is the period the ventricles depolarize and contract and then repolarize. If this period is extended too long, abnormal heart beats may occur. The guidelines recommend that patients be monitored for ECG changes when receiving intravenous haloperidol.

On 9/12/11 a review of Patient 1's clinical record indcated she had been admitted to the Intensive Care Unit (ICU) on 8/12/11 following an operation. On 8/17/11 a physcian ordered that Patient 1 be moved from the ICU to a telemetry (provides monitoring of the ECG) floor. On 8/18/11 a physcian ordered that Patient 1 be moved to the 4th floor which is a medical-surgical unit. The order was not timed but nursing staff noted the order at 8:30 a.m. Patient 1 had two 12 lead ECGs done on 8/12/11 and one on 8/15/11. The QT and corrected QT interval (QTc) was normal on all of them.

On 8/16/11 (no time) a physician ordered a one time dose of IV haloperidol. On 8/16/11 at 5:50 p.m. a nurse took a telephone order from a physician for haloperidol 2 milligrams (mg) IV every four hours as needed for agitation. A review of the medication administration record (MAR: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated that Patient 1 received three IV doses of haloperidol on each day of 8/16/11 and 8/17/11, four IV doses of IV haloperidol on 8/18/11 and no doses on 8/19/11. Patient 1 was discharged from the hospital on 8/19/11.

On 9/12/11 at 11:44 a.m. during an interview of Administrator C, she stated that 4th floor patients were not typically monitored by ECG on the 4th floor. On 9/13/11 at 12:37 p.m. during an interveiw of Administrative Pharmacist A, she stated that neither she nor Administrator C had found any evidence that Patient 1 had been monitored by telemetry while she was a patient on the 4th floor. She stated she was aware the patients who received IV haloperidol needed to be monitored by telemetry due to the potential for QT prolongation and torsades de pointes.



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