Healthcare Inspection. Oversight Review of Ophthalmology Adverse Drug Events: VA Greater Los Angeles Healthcare System Los Angeles, California.

摘要

The VA Office of Inspector General Office of Healthcare Inspections conducted an oversight review to assess actions taken by VA Greater Los Angeles Healthcare System (the facility) leadership in addressing intravitreal injections (treatment to deliver medication into the eye between the lens and the retina) that led to blindness in the treated eyes of five patients. This review describes actions taken by Veterans Integrated Service Network (VISN) 22 and the facility to address and respond to the adverse drug events and includes findings and makes a recommendation relative to these actions. We determined that appropriate actions were taken, including: (1) conducting initial institutional disclosures with the five affected patients; (2) halting the administration of Avastin intravitreal injections; and (3) reporting the adverse drug events to the VISN, the U.S. Food and Drug Administration (FDA), and the VA National Center for Patient Safety, which led to multiple external site visits that resulted in findings and recommendations. The facility has initiated corrective actions and implemented new procedures related to ordering, compounding, staffing, and staffing competencies. We determined that VISN and facility managers complied with Veterans Health Administration (VHA) policy in taking immediate action as described in this oversight review. They appropriately notified the patients and contacted FDA and VHA leaders while ascertaining the cause of the adverse drug events. The facilitys follow-up disclosure to the patients that a medication error occurred is consistent with VAs commitment to transparency. We noted that the facility Director convened an administrative board of inquiry (ABI) on February 23, 2012, to address additional administrative and patient safety issues. We recommended that the Facility Director ensure that recommendations from the local and external reviews are implemented and monitored, that the ABI is completed in a timely manner, and that corrective actions in response to the ABI are taken if indicated. The VISN and Facility Directors concurred with our findings and recommendation and provided an acceptable action plan. We will follow up on the planned actions until they are completed.