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Our objective was to determine whether the Toyota Production System process redesign resulted in diagnostic error reduction for patients who underwent cytologic evaluation of thyroid nodules. In this longitudinal, nonconcurrent cohort study, we compared the diagnostic error frequency of a thyroid aspiration service before and after implementation of error reduction initiatives consisting of adoption of a standardized diagnostic terminology scheme and an immediate interpretation service. A total of 2,424 patients underwent aspiration. Following terminology standardization, the false-negative rate decreased from 41.8% to 19.1% (P = .006), the specimen nondiagnostic rate increased from 5.8% to 19.8% (P < .001), and the sensitivity increased from 70.2% to 90.6% (P < .001). Cases with an immediate interpretation had a lower noninterpretable specimen rate than those without immediate interpretation (P < .001). Toyota process change led to significantly fewer diagnostic errors for patients who underwent thyroid fine-needle aspiration.

Scant published data exist on redesigning pathology practice based on error data. In this first step of an Agency for Healthcare Research and Quality patient safety project, we measured the performance metrics of thyroid gland fine-needle aspiration, performed root cause analysis to determine the causes of error, and proposed error-reduction initiatives to address specific errors. Eleven cytologists signed out 1,543 thyroid gland aspirates in 2 years, and surgical pathology follow-up was obtained in 364 patients. Of the 364 patients, 91 (25.0%) had a false-negative diagnosis and 36 (9.9%) a false-positive diagnosis. Root cause analysis showed that major sources of error were pre-analytic (poor specimen quality) and analytic (interpretation of unsatisfactory specimens as nonneoplastic and lack of diagnostic category standardization). We currently are evaluating the effectiveness of error reduction initiatives that target pre-analytic and analytic portions of the diagnostic pathway.