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When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine
  1. Paul L Epner1,
  2. Janet E Gans2,
  3. Mark L Graber3
  1. 1Paul Epner LLC, Evanston, Illinois, USA
  2. 2Evanston, Illinois, USA
  3. 3Healthcare Quality and Outcomes, RTI International SUNY Stony Brook School of Medicine, St James, New York, USA
  1. Correspondence to Paul L Epner, 1501 Hinman Ave, #7B, Evanston, IL 60201, USA; PEpner{at}

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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 non-laboratory 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.

The role of laboratory testing in establishing diagnoses

Diagnoses typically result from the patient history and physical. However, diagnostic testing is often used to confirm initial impressions or rule out alternatives, and at least 10% of all diagnoses are not considered final until clinical laboratory testing is complete.1 ,2 This number most likely underestimates the actual impact of testing on diagnosis. In the emergency room, clinical laboratory testing is ordered in more than 41% of all visits.3 Family physicians order tests in 29% of all patient visits, and general internists, in 38% of visits.4 These percentages would be even higher if the calculations were based only on the 33.9% of primary care visits that involve a new complaint.5

Advances in technology have also contributed to the increased importance of laboratory tests. In the past, laboratory tests were used to identify organ and system dysfunctions or diseases. While this is still true, testing nowadays is used to diagnose disease subtypes, as occurs when pathology reports of cancer are accompanied by tumour-specific and patient-specific …

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