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Based on review of documentation and interviews, the Hospital failed to ensure that performance improvement activities tracked medical errors and adverse events based on the following findings:


Background information: The Patient was 70 years of age and admitted to the hospital on 11/17/10 in end stage renal disease with regularly scheduled hemodialysis. Co- morbid diagnoses included aortic stenosis, coronary artery disease, high blood pressure, high lipids, anemia and gout. The Patient was on 10 regularly prescribed medications per day. Pertinent to this incident - the Patient was prescribed for Labetalol [to reduce high blood pressures] 100 mg. per mouth, two times per day.

On 12/1/10 during the Patient ' s regularly scheduled dialysis treatment, the Patient developed asymptomatic tachycardia. The EKG showed rapid atrial defibrillation with a ventricle rate of 149. The dialysis was stopped and treatment for the high heart rate was administered. The Patient was transferred to the telemetry unit. During the process of the Physician managing the Patient ' s acute change in condition, the Physician noted the Patient had not received the ordered Labetalol since discharge from the acute care hospital from which the Patient was transferred from on 11/17/10 - a 13 day period in which the prescribed Labetalol was not administered. Because the heart rate was not controlled, the Patient was transferred from the Rehabilitation Hospital for acute care.

Please see Tag A- 404 for specific information regarding the medication error.


1) The Director of Quality was interviewed in person on 12/21/10 at 8 am. The Director of Quality was working collaboratively with the Nurse Manager of 2 South in regards to conducting a root cause analysis of the medication error. The Director of Quality was informed the Nurse Manager had interviewed the three involved nursing staff for the medication error. However, interviews on 12/21/10 with the Night Shift Nurse who signed the 24 hour order notation at 2:15 pm and with the Medical Secretary at 2:10 pm who performed part of the medication transcription process, both indicated that the first time they were interviewed regarding the error was with this Surveyor on 12/21/10 - twenty days after the error was noted on 12/1/10.

2) The Charge Nurse was interviewed on 12/21/10 at 3 pm. The Charge Nurse was interviewed regarding the medication error by the 2 South Clinical leader several days after the error was discovered. The information obtained from the Charge Nurse by the Clinical Leader of 2 South regarding the medication error was not conveyed to the Director of Quality for analysis and consideration in development of corrective actions.

3) The Director of Quality said there was no quality assurance topic developed to analyze if the medication error was a system wide problem, individual error or generalizable with nurses at risk for making the same medication error and patients at risk for not receiving correctly ordered medications.

Based on review of 10 current patients sampled on 12/21/10 to compare physician orders and the MAR, patients are still at risk for not having prescribed medications administered or medications administered incorrectly. [Please see Tag A - 508, #2 for information regarding the sample analysis.]

Based on review of documentation, interviews and review of 10 current medical records, the Hospital failed to ensure that drug administration errors, adverse drug reactions and incompatibilities were immediately reported to the attending physician and if appropriate, to the hospital wide quality assurance program as evidenced by the following findings:

1) Review of the process for medication administration implemented by the nursing staff indicated that the nursing staff did not include cross reference of medications listed on the MAR against the Pharmacy Medication Profile as a component of ensuring medication administration accuracy.

2) During the Tour of the Patient Care Units conducted on 12/21/10, ten patients were randomly selected were for review of the MAR in comparison to the Pharmacy Medication Profile for accuracy. One of 10 patients was noted to have the order for Lopressor written in the MAR as scheduled for administration as twice a day. Review of the Physician's order sheet dated 12/7/10 at 8:30 pm. regarding the medication was illegible, but sections that were legible indicated the medication was to be administered once a day. As a result of illegibility and the lack of an effective medication check system, the medication error continued for approximately 10 days.

3) The Director of Pharmacy was interviewed in person on 12/21/10 at 9:45 am. The Director of Pharmacy, Director of Nursing and the Nurse Manager of 2 South confirmed that there is no relationship between the nursing staff and the pharmacy department in regards to checking and reconciling admission medication orders against the patient's regularly prescribed medications before the first administration to ensure no error occurs.

4) There is also no system to assure the MAR is checked against the computerized Pharmacy generated Medication Profile which lists the Patient's medications. At no point in the patient's hospitalization is the Computerized Medication Profile checked against the actively used MAR for medication administration. As a result, there is no system to "red flag" when an ordered medication is not administered or an error occurs. There is no system of back up by the pharmacy to check medication errors.

Based on review of documentation, interviews and a random sample of 10 current medical records that were selected to confirm the MAR accuracy with the physician orders, the Hospital failed to ensure that drugs and biologicals were prepared and administered in accordance with Federal and State laws and accepted standards of practice as evidenced by the following findings:


1) Review of the Physician ' s Admission Orders dated 11/17/10 at 5pm indicated the Patient was ordered for Labetalol [a medication which reduces high blood pressure] 100 mg per mouth two times per day. Review of the Medication Administration Record [MAR] indicated the Labetalol was not transcribed on the MAR. As a result, the Patient did not receive administration of the medication from 11/17/10 through 12/1/10 - a total of thirteen days - as a result of the transcription error.

2) Review of the Labetalol manufacturer's sheet indicated that "Abrupt discontinuation of any beta-adrenergic blocking agent, including Labetalol, can result in the development of myocardial ischemia, myocardial infarction, ventricular arrhythmias or severe hypertension, particularly in patients with pre-existing cardiac disease."

3) Review of the Hospital's policy titled: Transcription of Medication Orders, Section 4.0 Policy Statement, point 3, indicated that the nurse who checks or "notes" the transcribed orders on the doctor's order sheet verifies transcription accuracy, places his/her initials in the margins to the left of the medication order box, and faxes the orders to the pharmacy. The nurse initials and signs the signature section of the MAR.

Point 4 indicates that the nurses are responsible for checking patient orders written during the shift and any new/changed drug orders being administered for the first time. At the end of each shift, the nurse caring for that patient will verify that all orders for the shift have been accurately transcribed and noted. The Nurse completes this by writing "shift check; sign, date and time" on the physician order sheet. The night shift nurse will also double check all orders generated within the previous 24 hours for accuracy.


4) Review of the Hospital ' s internal root cause analysis of the medication error indicated that the Charge Nurse began the initial transcription of the Patient's regularly prescribed medications to the MAR record. Documentation indicated the Medical Secretary assumed the responsibility of the MAR transcription process from the Charge Nurse. In the process of the implementation of transcription and verification procedure, an interruption in the work flow from the Charge Nurse to the Medical Secretary, resulted in the medication: Labetalol - not being transcribed on the MAR.

Review of the MAR indicated that the Night Nurse signed off on the MAR as the medications transcribed were correct. This "double check" system of the medications failed.

5) Review of the Patient's medical record and the Hospital's root cause analysis indicated the incorrectly recorded MAR was utilized for the Patient's daily medication administration.

However, review of the Medication Profile Record dated 11/17/10 generated by the Pharmacy department did include the prescribed Labetalol 100 mg twice daily.

Review of the process for medication administration implemented by the nursing staff indicated that the nursing staff did not include cross reference of medications listed on the MAR against the Pharmacy Medication Profile as a component of checking medication administration accuracy.

6) Interviews with the Director of Pharmacy, Director of Nursing and the Director of Quality Improvement on 12/21/10 indicated the Nursing Department had no formal relationship with the Pharmacy Department regarding checking Patient's reported regularly prescribed medications with the Physician's admitting orders and the MAR. As a result, there was no system established by the Pharmacy Department to ensure the Patient received their regularly prescribed medications.

7) The medication error that occurred which resulted in the Patient not receiving the Labetalol occurred by the following nursing actions: The Charge Nurse started the transcription process and completed three medications listed on the physician's orders. The Medical Secretary continued the transcription process. The Medical Secretary missed the Labetalol in the transcription process. The medication was not identified as missing in the following 8 hour and 24 hour checks which require that the nurse signing off verify the accuracy of the transcription by comparing the MAR to the admission medication orders.

The policy for transcription of medications requires that two nurse initials are beside each medication before the first administration of the medication. Review of the MAR indicated there were two nurse initials beside each medication. Per policy, no further checks are required of the medications. If the first double check system implemented by nursing fails, there is no third check of the system by Pharmacy. That is how the Patient did not receive the medication for following 13 day period.