Thursday, April 28, 2005

Root Cause Analysis for Pap test Diagnostic Errors Due to Sampling Using a Lean Production System Improves Specimen Quality

Stephen S. Raab, Jennifer Condel, and Colleen M. Vrbin.

The potential usefulness of application of a lean production system, such as the Toyota Production System (TPS), to investigate underlying reasons for Pap test sampling adequacy has not been studied.

To apply TPS principles to the root cause analysis of Pap test sampling adequacy in a model gynecologic practice.

Design: Observational case study of the process of Pap test specimen collection by a single volunteer clinician, using TPS principles.
Setting: The clinical practice of one volunteer gynecologist of 355 total clinicians sending Pap tests to Magee-Womens Hospital (Pittsburgh, PA).
Participants: n/a
Intervention: n/a
Main outcome measures: Process measures for specimen collection included multiple characteristics of the cervix at sampling, the specific type of sampling device, multiple factors related to the specific clinical collection technique, and the clinician's impression of specimen adequacy at the time of sampling. Associations between these process measures and the outcome measure of final pathologic specimen adequacy were examined.

331 patient specimens collected between March 10 and September 18, 2004, were analyzed. There was a significant correlation between the clinician's assessment of specimen adequacy and the final pathologic assessment. No other significant associations between process measures and specimen adequacy were found. However, a decreasing trend in the proportion of inadequate specimens obtained by the volunteer clinician occurred (8.97% of specimens obtained from January 1, 2003 through March 10, 2004 compared to 4.53% during the study period).

Application of lean system principles to analysis of Pap test sampling adequacy in this case suggest that increased awareness of the specimen collection process itself appeared to improve specimen quality, an example of the Hawthorne effect. Further application of these principles to additional practices is needed to confirm this effect.

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