Errors upstream and downstream to the Universal Protocol associated with wrong surgery events in the Veterans Health Administration

Abstract

Background: The Universal Protocol has been associated with the prevention of wrong surgery procedures; however, such events still occur. This article explores wrong surgery events, defined as those incorrect procedures (wrong site, wrong side, wrong procedure, wrong patient, wrong level, wrong implant) that would have occurred despite the Universal Protocol including the performance of a time-out by the surgical team. Understanding why some of these events are not caught by the steps of the Universal Protocol, culminating in the time-out, can help the field to add upstream and downstream safeguards to help prevent these never events.

Methods: The Veterans Health Administration database of root cause analyses was queried for all cases involving an incorrect surgical procedure between 2004 and 2013 to determine the relative frequency and characteristics of wrong surgery events because of errors upstream and downstream to the Universal Protocol. This subgroup of wrong surgery events was selected from among all the wrong surgery events by 2 clinicians with expertise in patient safety (Kappa = .91).

Results: Forty-eight cases of wrong surgery events because of upstream/downstream errors were analyzed, representing 16% of the 308 root cause analyses for wrong surgery events reported during this period. Upstream errors included mislabeling of specimens, while downstream errors were associated with ineffective intraoperative process. Surgical procedures that were particularly vulnerable included wrong level spine operations, wrong patient prostatectomies, wrong implant cataract procedures, and wrong site skin lesion excisions.

Conclusions: Wrong surgery events can and do occur despite adherence to Universal Protocol including a time-out. The prevention of incorrect procedures requires complementary safety behaviors and technologies to address errors that occur upstream and downstream to the Universal Protocol and the time-out.

Keywords: Patient safety; Root cause analysis; Time-outs; Universal protocol; Wrong-site surgery.