Abstract
Wrong site surgeries (WSS) are classified as “never events” and signify adverse events that are preventable. The prevalence of procedures in the wrong location is up to 50 WSS per week in the United States. Informed consent (IC) related contributing factors include communication breakdowns between staff and across units, lack of cross-checking documents, equipment-related issues, and lack of automation in document coordination. As part of a patient safety initiative, a qualitative review of IC and WSS-related factors was conducted using patient safety event (PSE) data within a large healthcare system in the mid-Atlantic region. A word search query of the PSE database containing 132,683 PSEs from 2009 to 2017 was performed using a comprehensive codebook, and inter-rater reliability was established. Qualitative analysis of the PSE data indicated highest frequencies of the following codes: mAbsence of consent for treatment (25.7%), Incorrect or missing information recorded in the IC form (15.5%), and Ambiguity in laterality of the procedure on IC form/other medical documentation (12.5%). These contributing factors often lead to Late procedure start times (6.6%) and New consent document procurement (6.42%). These findings inform the need for system-based interventions to reduce risk. A targeted intervention focused on improving the design of IC forms and other medical documents could address some of these vulnerabilities. Developing a system-based approach to cross check procedure information could increase the reliability of system safeguards to reduce the risk of potential patient harm.
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