Protecting patients from an unsafe system: the etiology and recovery of intraoperative deviations in care

Abstract

Objective: To understand the etiology and resolution of unanticipated events in the operating room (OR).

Background: The majority of surgical adverse events occur intraoperatively. The OR represents a complex, high-risk system. The influence of different human, team, and organizational/environmental factors on safety and performance is unknown.

Methods: We video-recorded and transcribed 10 high-acuity operations, representing 43.7 hours of patient care. Deviations, defined as delays and/or episodes of decreased patient safety, were identified by majority consensus of a multidisciplinary team. Factors that contributed to each event and/or mitigated its impact were determined and attributed to the patient, providers, or environment/organization.

Results: Thirty-three deviations (10 delays, 17 safety compromises, 6 both) occurred--with a mean of 1 every 79.4 minutes. These deviations were multifactorial (mean 3.1 factors). Problems with communication and organizational structure appeared repeatedly at the root of both types of deviations. Delays tended to be resolved with vigilance, communication, coordination, and cooperation, while mediation of safety compromises was most frequently accomplished with vigilance, leadership, communication, and/or coordination. The organization/environment was not found to play a direct role in compensation.

Conclusions: Unanticipated events are common in the OR. Deviations result from poor organizational/environmental design and suboptimal team dynamics, with caregivers compensating to avoid patient harm. Although recognized in other high-risk domains, such human resilience has not yet been described in surgery and has major implications for the design of safety interventions.

Figure 1

Video Recording Configuration. Left, view from camera installed in operative lights. Center, view from 270° camera. Right, anesthesia monitor feed.

Figure 2

Conceptual Model of Safety Compromise. The course of the operation is represented by the solid black line. 1. At the beginning of the case, the patient’s level of safety is determined largely by baseline patient factors. 2. A safety compromise occurs, decreasing the level of safety, but the case remains within the Zone of Safety; buffering by other factors maintains a safe environment for the patient. 3. Another safety compromises decreases the level of safety beyond the Zone of Safety, but partial recovery (upward slope) prevents the patient from progressing further towards harm. 4. A final safety compromise decreases the level of safety below the Threshold for Harm; negative patient outcomes are manifested. 5. Stabilization (flattened slope) is achieved; the patient’s harm is not reversed, but no further harm is done.

Figure 3

Attribution of Factors to Patient, Providers, or Environment/Organization. Top, distribution of factors that contributed to deviations among patient, providers, or environment/organization. Bottom, distribution of factors that aided in compensation and/or mitigation of deviations among patient, providers, or environment/organization.