External quality control of cervical cytopathology: Interlaboratory variability

Abstract

Objective: To compare the variability of screening tests held at laboratories with the Unit for External Quality Control (UEQC), checking the frequency of cases that were discordant, false-positive, false-negative, unsatisfactory or that had a delay in clinical management and diagnostic agreement. Materials and Methods: The study analyzed 10,053 screening tests from January 2007 to December 2008, including all positive cases, all those that fall under unsatisfactory and at least 10% of negative screening tests. The magnitude of the agreement was analyzed using the kappa coefficient. Results: Out of the 10,053 cases analyzed, 7.59% were considered disagreeing, and it was estimated that 1.1% were false-negative. There was a delay in the clinical procedure regarding 2.44% cases. There were 2.82% of cases identified as false-positive and 1.24% as unsatisfactory. The diagnostic agreement was excellent (kappa = 0.81). The agreement of most laboratories concerning screening tests was classified as very good. The agreement of the sample adequacy was reasonable (kappa = 0.30) and the agreement regarding the representation of epithelia was considered excellent. Conclusion: Most laboratories showed very good agreement; however, it is worthy of note that to establish the standardization of diagnostic criteria, and enhance the accuracy of screening and improve the quality of cytopathology test results, it is necessary to perform external quality control. © 2013 S. Karger AG, Basel.