Safely Improving Emergency Diagnostic Testing through Clinical Safe Harbors

Our research team hypothesizes that a predetermined standard of care, in the form of a carefully constructed and narrowly targeted safe harbor, can be defined using medical evidence and consensus among patients, medical professionals, policy makers and legal experts. The safe harbor will serve as a special kind of clinical practice guideline or protocol. Importantly, the research team expects that the safe harbors will follow the appropriate protocol to serve as the legal standard of care, not just evidence of the standard of care, under existing federal law. 42 U.S.C. 1320c-6(c)(2). This distinction is of critical importance in encouraging adoption of a medical liability safe harbor and making it effective. Our proposal addresses the Agency for Healthcare Research and Quality funding opportunity PA-15-179 Understanding and Improving Diagnostic Safety in Ambulatory Care: Strategies and Interventions (R18). Specifically to “enhance the resilience and safety of diagnostic work” as well as to evaluate strategies and interventions for reducing patient harm, including approaches “that enable organizations, providers, and patients to better anticipate emerging diagnostic risk before harm occurs.” In this regard, our proposal is highly relevant to the emergency department (ED), which serves as the gatekeeper for acute medical conditions, and is a place where a substantial amount of radiologic procedures occur.