When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine

To cite: Epner PL, Gans JE, Graber ML. BMJ Qual Saf 2013;22:ii6–ii10. Many diagnostic errors are associated with laboratory testing, and many of these are preventable. However, a reduction in testing-related diagnostic errors (TDE) is hindered by the absence of a well-defined relationship between diagnostic harm and the testing process (whether from laboratory or nonlaboratory sources) as well as by a lack of relevant measures for evaluation. The goal of this paper is to review current models that describe the testing process, and then propose a different approach to facilitate the reduction of diagnostic errors and harm related to diagnostic testing. We then demonstrate how this approach can be used to develop measures that may improve patient outcomes and guide future research to reduce TDE. Finally, we highlight the need for collaboration between clinicians and laboratory physicians and scientists to achieve these goals.