Scientific issues related to the cytology proficiency testing regulations

The member organizations of the CETC feel strongly that there are significant flaws associated with the proposed proficiency test and its implementation. The most immediate modifications include lengthening the required testing interval, utilizing stringently validated and continuously monitored slides, changing the grading scheme and changing the focus of the test from individuals to laboratory level testing, as described above. Integration of new computer-assisted and location-guided screening technologies into the testing protocol is necessary for the testing program to be compliant with the current CLIA law. The regulation also needs to be flexible enough to accommodate new technologies that are implemented in laboratory practice, education and administration of the test. The changes recommended in this document address the most immediate technical and scientific concerns with the current implementation of PT for gynecologic cytology. The CETC will be submitting a subsequent document, following full review of the current regulations, with recommendations for changes, justifications and impact.