The Nature, Causes, and Clinical Impact of Errors in the Clinical Laboratory Testing Process Leading to Diagnostic Error: A Voluntary Incident Report Analysis.

Objectives: Diagnostic errors, that is, missed, delayed, or wrong diagnoses, are a common type of medical errors and preventable iatrogenic harm. Errors in the laboratory testing process can lead to diagnostic errors. This retrospective analysis of voluntary incident reports aimed to investigate the nature, causes, and clinical impact of errors, including diagnostic errors, in the clinical laboratory testing process.

Methods: We used a sample of 600 voluntary incident reports concerning diagnostic testing selected from all incident reports filed at the University Medical Center Utrecht in 2017-2018. From these incident reports, we included all reports concerning the clinical laboratory testing process. For these incidents, we determined the following: nature: in which phase of the testing process the error occurred; cause: human, technical, organizational; and clinical impact: the type and severity of the harm to the patient, including diagnostic error.

Results: Three hundred twenty-seven reports were included in the analysis. In 77.1%, the error occurred in the preanalytical phase, 13.5% in the analytical phase and 8.0% in the postanalytical phase (1.5% undetermined). Human factors were the most frequent cause (58.7%). Severe clinical impact occurred relatively more often in the analytical and postanalytical phase, 32% and 28%, respectively, compared with the preanalytical phase (40%). In 195 cases (60%), there was a potential diagnostic error as consequence, mainly a potential delay in the diagnostic process (50.5%).

Conclusions: Errors in the laboratory testing process often lead to potential diagnostic errors. Although prone to incomplete information on causes and clinical impact, voluntary incident reports are a valuable source for research on diagnostic error related to errors in the clinical laboratory testing process.