Achieving High Reliability in Histology:  An Improvement Series to Reduce Errors.

Objectives: Despite sweeping medical advances in other fields, histology processes have by and large remained constant over the past 175 years. Patient label identification errors are a known liability in the laboratory and can be devastating, resulting in incorrect diagnoses and inappropriate treatment. The objective of this study was to identify vulnerable steps in the histology workflow and reduce the frequency of labeling errors (LEs). Methods: In this 36 -month study period, a numerical step key (SK) was developed to capture LEs. The two most prevalent root causes were targeted for Lean workflow redesign: manual slide printing and microtome cutting. The numbers and rates of LEs before and after interventions were compared to evaluate the effectiveness of interventions. Results: Following the adoption of a barcode-enabled laboratory information system, the error rate decreased from a baseline of 1.03% (794 errors in 76,958 cases) to 0.28% (107 errors in 37,880 cases). After the implementation of an innovative ice tool box, allowing single piece workflow for histology microtome cutting, the rate came down to 0.22% (119 errors in 54,342 cases). Conclusions: The study pointed out the importance of tracking and understanding LEs by using a simple numerical SK and quantified the effectiveness of two customized Lean interventions. Overall, a 78.64% reduction in LEs and a 35.28% reduction in time spent on rework have been observed since the study began.