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An Analysis of Electronic Health Record-Related Patient Safety Concerns

Author: Derek W. Meeks, MD

Primary Advisor: Dean F. Sittig, PhD

Committee Members: Hardeep Singh, MD, MPH

Masters thesis, The University of Texas Health Science Center School of Health Information Sciences at Houston.


Importance: Despite the benefits of electronic health records (EHRs), unintended safety risks have emerged. These risks are often challenging to identify and mitigate as they may involve multiple interacting components of the healthcare delivery system.

Objective: To analyze EHR-related safety concerns reported within a large, integrated healthcare system with a well-established EHR.

Design, Setting, Measures: The Informatics Patient Safety Office of the Veterans Health Administration maintains a non-punitive, voluntary reporting system to collect and analyze data on EHR-related adverse events, potential events, and near misses. We analyzed reports of events that received a complete investigation, categorizing the qualitative data from the reports through framework analysis. Our analysis was grounded in a previously developed sociotechnical conceptual model that accounts for both technical and non-technical dimensions of EHR-related safety. We also determined whether concerns were related to unsafe technology versus unsafe use of technology. Finally, we sought to identify underlying high-risk situations common to multiple events.

Results: We extracted 100 consecutive cases investigated between August 2009 and May 2013 of which 25 involved unsafe use of technology. More than two-thirds (70%) of reports involved 2 or more dimensions of our conceptual model. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Emergent areas of potential high-risk EHR use included unmet data display needs in the EHR, safety risks with software upgrades or modifications, risks of “hidden dependencies” within the EHR system, Page 4 of 24 and risks related to data transmission across different components of the EHR. These four risk areas accounted for 94% of the reports analyzed.

Conclusions and Relevance: EHR-related risks related to both unsafe technology and unsafe use of technology persist despite the highly sophisticated EHR infrastructure represented in our data source. Certain types of risks appeared especially prominent and may represent high priority areas for patient safety interventions. Because these risks have complex sociotechnical origins, institutions currently implementing EHRs should consider building an infrastructure to monitor and learn from ongoing safety concerns.

Key Words: Electronic Health Records, sociotechnical, reporting systems, medical errors, patient safety