Abstract

Recent passage of the American Reinvestment and Recovery Act (ARRA) increases pressure on healthcare practitioners and organizations to implement currently available electronic health records (EHRs). Research and experience gained to date shows that such implementation efforts are difficult, costly, time-consuming, and fraught with many unintended consequences1. Evaluation of these systems after implementation suggests that they do not routinely meet safety standards of other safety-critical industries2. The aggressive timeline proposed in the ARRA bill means that a large number of practitioners and organizations will soon be attempting a monumental feat without the time or ability to customize these systems to their local workflows3. In a previous article, we proposed 8 dimensions or “rights” of EHR safety that addressed the complex social, technical, and personal issues associated with EHR use4. The goal of this article is to describe an approach for a comprehensive EHR monitoring and evaluation framework (i.e., the 8th dimension of EHR safety). Without such a comprehensive framework, safe and effective EHR use cannot be assured. This proposed framework has five essential components: 1) ability for practitioners and organizations to report patient safety events or potential hazards related to EHR use 5,6; 2) enhanced EHR certification that includes specific assurances that good software development procedures7 have been followed along with evidence that previously reported adverse events and hazards have been addressed; 3) self-assessment, attestation, testing, and reporting by both clinicians and healthcare organizations that all eight dimensions of safe EHR use have been addressed; 4) Local, state, and national oversight in the form of an on-site, in-person accreditation of EHRs as implemented and used by clinicians in the healthcare setting; 5) A national EHR-related adverse event investigation board that reviews incident reports and has the authority to investigate.

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