How can laboratorians safely calculate workload for FDA-approved semi-automated cytology screening device?
To ensure the safety and effectiveness of these devices, given their importance as women’s health screening tests, the FDA has determined that laboratorians should use the following method when calculating workload. The calculation method applies to both semi-automated cytology screening systems currently on the market (Hologic’s ThinPrep® Imaging System and Becton Dickinson’s Focal Point™ Guided Screening System): • All slides with full manual review (FMR) count as 1 slide (as mandated by CLIA’88 for manual screening) • All slides with field of view (FOV) only review count as 0.5 or ½ slide • Then, slides with both FOV and FMR count as 1.5 or 1½ slides • Use these values to count workload, not exceeding the CLIA maximum limit of 100 slides in no less than an 8-hour day.