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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 patient events.

Findings included:

Background information:

Review of the medical record indicated that on 5/4/10 at approximately noon, the Patient was riding his bicycle and was struck by a truck. The Patient was receiving emergency medical services at the side of the road and one of the Patient's community based Mental Health service clinicians saw the Patient and stopped to help. The Patient's Mental Health Case Manager [CM] said they called the Emergency Department and faxed over the Patient's pertinent medical information and his current list of medications. Review of the medical record indicated the list was faxed on 5/4/10 at 1:16 pm.

1) Review of the Emergency Department [ED] Medication Reconciliation Form dated 5/4/10 which lists all medications the Patient was taking prior to admission, correctly listed the medications and did NOT include the Clozapine. The ED Nursing Documentation admission form, section titled history, dated 5/4/10 also listed the medications correctly and did NOT include the Clozapine

2) The ED Physician/General Surgeon who admitted the Patient was interviewed by telephone on 5/11/10 at 12:50 pm. The ED Physician said because the Patient had no information on his person and he was not a good historian regarding his health status, he went on line to access his computerized medical record. Review of the Longitudinal Medical Record [LMR], a health care system's computerized medical record, indicated the Patient was taking Clozapine 300 mg by mouth everyday. Interview with the Patient's Mental Health Case Manager on 5/10/10 at 4:40 pm indicated the Patient had not taken this medication for at least the past year and one half.

The ED Physician said he only utilized this source to write the Patient ' s admission medication orders.

3) Review of the Patient ' s admitting pharmacy orders dated 5/4/10 at 5:55 pm indicated that Clozapine 300 mg was to be taken every day.

4) Review of the Medication Administration Record dated 5/5/10 indicated the Patient received 300 mg of Clozapine at 8:10 am.

The Patient had previously been taking Clozapine for the treatment of schizoaffective disorder and this was a very high daily dose [the daily range is 300-450 mg]. However, this drug must be increased in increments of 25-50 mg per day based on clinical status over a period of two weeks. The drug must be re-titrated with extreme caution even after 24 hours of discontinuing the drug. High doses can result in mild sedation, low blood pressure and an increased heart rate.

5) The Orthopedic Nurse Practitioner was interviewed in person on 5/10/10 at 10:19 am. When the Orthopedic Nurse Practitioner saw the Patient the morning of 5/5/10, she reviewed the medications and noted the high dosage of Clozapine. The Orthopedic Nurse Practitioner phoned the Mental Health Case Manager and was informed the Patient had not been taking the drug for a long period of time and he should not have received it. The Orthopedic Nurse Practitioner wrote an order to discontinue the medication and instructed the nursing staff to observe the Patient closely for signs of toxic effects. The Orthopedic Nurse Practitioner said the Patient slowly declined over the course of the day: his heart rate was elevated and his oxygen saturation was below normal. The Patient was also not as alert as he was in the morning when the Orthopedic Nurse Practitioner first spoke with the Patient and was drifting in and out of sleep. The Orthopedic Nurse Practitioner said the Patient was admitted to the Intensive Care Unit for observation. By evening, the Patient was not alert, became very agitated and was mumbling and speaking incoherently.

6) The Orthopedic Unit Nurse who administered the 300 mg of Clozapine on the morning of 5/5/10 at 8:10 am, was interviewed in person on 5/10/10 at 1:40 pm. The Nurse said she performed the admission medications reconciliation task. The Nurse said she referred to the
"purple form" which is the medication reconciliation form prepared by the ED staff. That form was correct: the Clozapine was NOT on the list of medications the Patient was taking prior to admission. The Nurse said she took the form to the Patient's room and went over the list of medications with the Patient. The Nurse said the Patient was mumbling and not a good historian. The Nurse said she was not concerned that the medication was not on the list because she said that it is not uncommon for patients to be on new or additional medications after they are admitted.

7) Review of the Hospital Policy titled: Medication Reconciliation indicated that on inpatient units, the nurse on the receiving unit performs a safety check and follows up with the ordering/attending prescriber to reconcile unexplained differences between the home/preadmission medications list and orders. This check serves as a failsafe to prevent unintended discrepancies. It is recommended that the prescriber and/or the nurse document the reasons for the differences between home medications and current orders.

8) Interview with the Orthopedic Nurse and the prescribing ED Physician indicated that they did not follow this step as required in the Hospital policy.

9) The ED Nurse and the General Surgeon who cared for the Patient in the ED and admitted the Patient also did not follow this step as required in the Hospital policy.

10) Additionally, when the LMR screen was viewed on 5/11/10 - the day of the survey, the Clozapine was still incorrectly listed as a medication the Patient was currently taking.

11) Review of the medical record indicated that all the physician consultation documentation sheets incorrectly listed Clozapine as a medication the Patient was currently taking.

12) Interview with the Risk Manager, Nurse Manager of the Orthopedic Unit, Associate Chief Nurse, Nurse Manager of the ED, Nurse Manager of the Intensive Care Unit and the Manager of the Pharmacy on 5/10/10, all indicated that the lack of current and correct information in the LMR is an ongoing problem. They said ED staff and ED consulting physicians tend to utilize the LMR system exclusively.

Based on review of documentation and interviews, 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.

Findings included:

1) The Risk Manager was interviewed in person on 5/11/10 at 9 am. The Risk Manager said there was no incident report filled out regarding the medication error: that the Patient received Clozapine on 5/5/10 at 8:10 am when he should have not received the drug. As a result of the medication error not being reported, the Quality Improvement team and the Pharmacy Department had no opportunity to perform a root cause analysis and take immediate action to prevent such medications errors from occurring again. As demonstrated in Tag A 286, the medication error indicated a system wide problem that affected all patients as they moved from an outpatient/community setting to the hospital, lack of following hospital policy and lack of accurate computerized information that clinicians, particularly the physicians, utilized frequently.

2) Review of the Hospital Policy titled: Adverse Event Reporting, section on Identification and Reporting, indicated that the individual who first identifies the event should submit a report as soon as possible after the event. If significant injury has, or may occur, the Director of Risk Management should be immediately notified during regular business hours. After hours, the Nursing Supervisor should be contacted. The Nursing Administrative Supervisor should inform the Administrator On Call about the event if indicated.

3) As noted in Tag A 286, point 5, the Orthopedic Nurse Practitioner was the first person to note the medication error on 5/5/10 within a few hours after the Patient received 300 mg of Clozapine in error. Because the Orthopedic Nurse Practitioner was the first person to note the medication error, she should have filled out an incident report and notified the Risk Manger.