Dissemination of Lean methods to improve Pap testing quality and patient safety.

OBJECTIVE: To determine if the implementation of Lean methods resulted in improved Pap test quality and diagnostic accuracy in 5 clinician practices. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: Disseminating Lean methods across a group of clinicians resulted in improved Pap test quality and diagnostic accuracy.

Improving Papanicolaou test quality and reducing medical errors by using Toyota production system methods.

OBJECTIVE: The objective of the study was to determine whether the Toyota production system process improves Papanicolaou test quality and patient safety. STUDY DESIGN: An 8-month nonconcurrent cohort study that included 464 case and 639 control women who had a Papanicolaou test was performed. Office workflow was redesigned using Toyota production system methods by introducing a 1-by-1 continuous flow process. We measured the frequency of Papanicolaou tests without a transformation zone component, follow-up and Bethesda System diagnostic frequency of atypical squamous cells of undetermined significance, and diagnostic error frequency. RESULTS: After the intervention, the percentage of Papanicolaou tests lacking a transformation zone component decreased from 9.9% to 4.7% (P = .001). The percentage of Papanicolaou tests with a diagnosis of atypical squamous cells of undetermined significance decreased from 7.8% to 3.9% (P = .007). The frequency of error per correlating cytologic-histologic specimen pair decreased from 9.52% to 7.84%. CONCLUSIONS: The introduction of the Toyota production system process resulted in improved Papanicolaou test quality.

Willingness to pay for new Papanicolaou test technologies.

The amount of money a woman is willing to pay for liquid-based cytology technology has not been measured. In the present study, 175 women answered a questionnaire asking how much they would pay to decrease their risk of dying of cervical cancer if a new (liquid-based) Papanicolaou (Pap) test was used in place of the conventional smear. When women assumed that the new Pap test reduced the risk of dying of cervical cancer from 1 in 37,000 to 1 in 50,000, the mean amount they were willing to pay was $237. If women had more than 2 children, they were willing to pay more for the new Pap test than women with 2 or fewer children. These data indicate that liquid-based and conventional Pap tests are undervalued and that cost-effectiveness studies generally have not taken into account the preference of women for new Pap test technologies.