Operational Measurement of Diagnostic Safety: State of the Science

Diagnostic errors pose a significant threat to patient safety, resulting in substantial preventable morbidity and mortality and excess healthcare costs.¹ Diagnostic errors are also among the most frequent reasons for medical malpractice claims.² In 2015, the National Academies of Sciences, Engineering, and Medicine (NASEM) highlighted the scope and significance of diagnostic safety in its report Improving Diagnosis in Health Care.³ Among NASEM’s recommendations is a call for accrediting bodies to require healthcare organizations (HCOs) to “monitor the diagnostic process and identify, learn from, and reduce diagnostic errors and near misses in a timely fashion.”³

Measurement of diagnostic performance is necessary for any systematic effort to improve diagnostic quality and safety. While numerous healthcare performance measures exist (the National Quality Forum [NQF] currently endorses hundreds of measures),^4,5 none is being used routinely to assess and address diagnostic errors. Only a few U.S. healthcare organizations have explored measurement of diagnostic safety, and the development of diagnostic safety measures remains in its infancy.⁶ However, diagnostic errors are increasingly prominent in the national conversation on patient safety.

Several stakeholders have recently launched initiatives and research projects to advance development and implementation of diagnostic safety measurement.^7-11 These stakeholders include the Agency for Healthcare Research and Quality, the NQF, the Centers for Medicare & Medicaid Services, the Society to Improve Diagnosis in Medicine, and philanthropic foundations such as the Gordon and Betty Moore Foundation. It is thus reasonable to expect that HCOs will face increasing expectations to measure and improve diagnostic safety as part of their quality and safety programs.

In parallel with calls for improving diagnostic safety is a growing emphasis on the concept of a learning health system (LHS). LHSs can be conceptualized at various levels, including the care team level, the HCO level, the external level (e.g., State or national), or within a specific improvement initiative or collaborative. In LHSs, leaders are committed to improvement, outcomes are systematically gathered, variation in care within the system is systematically analyzed to inform and improve care, and a continuous feedback cycle facilitates quality improvement based on evidence.¹²

Rigorous measurement of quality and safety should be an essential component of an LHS.^13,14 Further, measurement is only valuable to the extent that it is actionable and leads to improved care delivery and outcomes.¹⁵ New and emerging measures of diagnostic safety should therefore be evaluated not only in terms of their validity but also their potential to inform pragmatic strategies to improve diagnosis.¹⁶ At present, most of the tools and strategies that organizations use to detect patient safety concerns cannot always specifically detect diagnostic error, and even when these errors are uncovered, analysis and learning are limited.¹⁷

Although a coordinated national strategy to measure diagnostic safety remains an aspirational goal, recent research has yielded practical guidance for HCOs to start using measurement to enhance diagnostic safety. Measurement strategies validated in research settings are approaching readiness for implementation in an operational context. Equipped with this knowledge, HCOs have an opportunity to develop and implement strategies to learn from diagnostic safety events within their own walls.

In this Issue Brief, we discuss the state of the science of operational measurement of diagnostic safety, informed by recent peer-reviewed scientific publications, innovations in real-world healthcare settings, and initiatives to spur further development of diagnostic safety measures. Our aim is to provide knowledge and recommendations to encourage HCOs to begin to identify and learn from diagnostic errors.