After implementation of cultural and system changes to improve patient safety, we observed significant reductions in the number of SSEs and increases in the days between SSEs. Although we did not reach our goal of 0.2 events, both statistical process control and Wilcoxon rank-sum analyses confirm these improvements to be statistically significant. More importantly, they are unquestionably clinically significant, equating to 62 fewer SSEs over the last 5 years. During the initial phase of the interventions, results from the safety culture survey worsened. However, as the initiative progressed, there was improvement.
Our experience of significant reduction in SSEs is the first that we are aware of in the published literature. Although we do not have data on which drivers or interventions most affected this change, our bundle of an error prevention system, restructured safety governance, a cause analysis structure, lessons learned program, and specific tactical interventions was strongly associated with fewer SSEs. We believe this set of interventions, designed to reach every employee, is likely to achieve similar patient safety advances in other health systems if adjusted to the local context.
A more positive safety culture has been associated with fewer adverse events in hospitals.42
Many hospitals have measured and reported their patient safety culture; however, there are few reports of multiple surveys to determine the change in patient safety culture over time. Our leadership was acutely aware of the initial decrease in some patient safety culture outcomes in the second and third surveys. Such results have been reported previously and may be due to the increased focus on patient safety and error prevention and the perception that change is not happening fast enough.43–46
In addition, change takes time. Our leadership was confident that our interventions would eventually result in an improved safety culture.
Our overall response rates were calculated by using total employees as the denominator, rather than number of clinicians. Nonetheless, the improvement in the overall patient safety grade from 2007 (1 year after the interventions began) to 2009 was statistically significant. Although our study design did not allow us to attribute causation, our experience with this and other quality improvement initiatives leads us to believe that our interventions drove the culture change that was a prerequisite to safety outcomes improvement. In addition, our experience seems to affirm that process improvement initiatives alone are not sufficient to drive necessary culture change.
The major theoretical model for our approach was based on 5 key concepts guiding high reliability organizations: sensitivity to operations, reluctance to simplify, preoccupation with failure, deference to expertise, and resilience.4,5
These organizations strive to create a culture and processes that drastically reduce system failures and effectively respond when failures do occur.7
Our systematic, whole-system approach to reducing SSEs included a transparent, consistent method for identifying safety events; a standardized taxonomy for classifying failures; and a strict method to determine root causes, drive development of specific interventions, and focus organizational attention.
Some limitations of our study are that the interventions occurred at a single site, we do not have data from a control hospital, and multiple interventions were made simultaneously, resulting in what, in describing the etiology of disease, has been called a web of causation.31,47
We believe the simultaneous, multifaceted approach was crucial in changing behavior and culture and that no single change was responsible for the results obtained. In addition, this work was conducted over several years at a large pediatric medical center with a long history of improving care20
and a robust infrastructure for tracking outcomes and harm. However, we believe these methods can be generalized to other health care organizations if adapted to address contextual factors.48,49
Multisite studies and a detailed analysis of the percent penetration of the interventions will allow further improvement. For example, we are currently in a collaborative with all 8 children’s hospitals in Ohio to build improvement capability, reduce SSEs, and improve patient safety culture.
Improving patient safety is an ongoing challenge. We continue to focus on changing behavior and understand that this will require years of persistence. We believe additional factors and experience from outside health care will be important to further improvement. We have begun a new, organization-wide focus on situation awareness (ie, knowing what is going on around you and what is likely to happen next) to eliminate unrecognized clinical deterioration and delayed diagnosis as a cause of serious harm.7
We are also increasing emphasis on human factors engineering; that is, using knowledge about human behavior in system design and redesign.7,50