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J Am Med Inform Assoc. 2014 Nov-Dec;21(6):1053-9. doi: 10.1136/amiajnl-2013-002578. Epub 2014 Jun 20.

An analysis of electronic health record-related patient safety concerns.

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Houston VA Center for Innovations in Quality, Effectiveness and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas, USA Department of Family and Community Medicine, Baylor College of Medicine, Houston, Texas, USA.
Houston VA Center for Innovations in Quality, Effectiveness and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas, USA Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Informatics Patient Safety, Office of Informatics and Analytics, Veterans Health Administration, Ann Arbor, MI and Albany, NY, USA.
University of Texas School of Biomedical Informatics and UT-Memorial Hermann Center for Healthcare Quality and Safety, Houston, Texas, USA.



A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system.


The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports.


We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. 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. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or 'hidden dependencies' within the EHR.


EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after 'go-live' and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA.


Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them.


Electronic Health Records; human factors; medical errors; patients safety; reporting systems; sociotechnical

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