Dissemination of Lean Methods to Improve Pap Testing Quality and Patient Safety

Abstract

To determine if the implementation of Lean methods resulted in improved Pap test quality and diagnostic accuracy in 5 clinician practices. We performed a 1-year case-control study that included 5,384 control (preintervention) and 5,442 case (postintervention) women who had a Pap test procured by 1 of 5 clinicians. Using Lean methods, the clinicians increased their focus of Pap test procurement by creating a "one-by-one" workflow and recorded process completion using a Lean checklist. We compared the case and control Pap test quality and accuracy measures using the proportion of Pap tests lacking a transformation zone component, proportion of unsatisfactory Pap tests, frequency of newly detected cervical intraepithelial neoplasia following a previous benign Pap test, and proportion of Pap tests with a diagnosis of atypical squamous cells of unknown significance. After the intervention, there was a statistically significant decrease in the mean proportion of Pap tests lacking a transformation zone component, p =.011. Two of 5 clinicians showed a statistically significant decrease in their unsatisfactory Pap test frequency, although the overall Pap test unsatisfactory frequency for the case group was not statistically significant lower, p =.087. The case group showed a 114% increase in newly detected cervical intraepithelial neoplasia following a previous benign Pap test, p =.004. There was no statistically significant difference for the proportion of Pap tests with a diagnosis of atypical squamous cells of unknown significance, p =.908. Disseminating Lean methods across a group of clinicians resulted in improved Pap test quality and diagnostic accuracy.