American society of cytopathology workload recommendations for automated pap test screening: Developed by the productivity and quality assurance in the era of automated screening task force

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Abstract
Based on current literature and the best available research to date, the current FDA workload limits for automated image‐assisted screening, including the ThinPrep Imaging System and the FocalPoint GS, of 100 slides/day (imaged only slides counted as 0.5) are extremely high and may be associated with significant reduction in sensitivity. This task force has proposed six recommendations relating to cytotechnologist (CT) workload in automated image‐guided Pap test screening, which have already been endorsed by major pathology professional societies. These evidence‐based recommendations, however, pertain only to gynecologic specimens with image‐assisted screening, as there is no current available data to justify modifying screening practices regarding non‐gynecologic specimens. The proposed recommendations are as follow: 1) CT workday should not include more than 7 hours of Pap test screening in a 24‐hr period, and an 8‐hr shift day must include at least 2 paid mini‐breaks of 15 minutes each and a 30‐minute lunch break. 2) Future Studies examining CT workload should use actual hours of screening rather than lesser number of hours extrapolated to 8‐hour days. 3) Average laboratory CT workload should NOT exceed 70 slides/day (slides counted per 2010 FDA bulletin). 4) Proportion of imaged slides that undergo full manual review should be at least either 15%, or twice (2×) the epithelial cell abnormality (ECA) rate, whichever is greater. 5) ECA‐adjusted workload measure is a promising method for calculating and monitoring CT workload, but further studies of this method are necessary before full endorsement. 6) CT productivity and workload limits are just one aspect of a good quality assurance program in a cytology laboratory, so other quality indicators to assess CT performance are essential. Diagn. Cytopathol. 2013.

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