The role of proficiency testing in ensuring quality: findings from the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference working group 3.

Context: Implementation of proficiency testing for gynecologic cytology was delayed 20 years because of challenges addressing the subjective nature of cytologic interpretation and replicating normal working conditions. Concern remains regarding test scoring, slide validation, test environment, and other issues. How these test results are, or should be, used in quality management has never been explored.

Objective: To provide information on good laboratory practices for gynecologic cytology proficiency testing based on findings from the College of American Pathologists' survey-based project funded by the Centers for Disease Control and Prevention.

Data Sources: An expert working group evaluated results from a Web-based, national laboratory survey plus responses from follow-up questions and findings from the literature. The group created statements on good laboratory practices pertinent to proficiency testing and its role in quality management, which were discussed and voted on at a consensus conference.

Conclusions: Two-thirds of laboratories report having an individual with an unsuccessful proficiency testing score. More than 90% did not initiate any remedial action for 1 or 2 unsuccessful tests; 84% of laboratories reported they actively monitored results from proficiency testing, but most laboratories did not initiate any remedial action for cytotechnologists (81.4%; 376 of 462) or pathologists (87.7%; 405 of 462) who passed a proficiency test but who did not score 100%. Proficiency testing pass-fail rates should be monitored globally for the laboratory and for each individual. Proficiency testing slides should be prescreened by cytotechnologists for pathologists who are not primary screeners. Remedial action should not be required for a passed, but imperfect, test. No remedial action is required for an unsuccessful, first proficiency test result before retesting.