The FDA provides guidance on safely calculating workload for FDA-approved semi-automated gynecologic cytology screening devices. The purpose is to clarify how to count fields of view (FOV) and full manual slide reviews (FMR) to establish maximum workload limits.
Issues with Workload Recording: Current product labeling has led to variability and lack of standardization in counting. Individual maximum daily workload limits are not being established by technical supervisors as mandated by CLIA 88.
Solution: The FDA recommends using a specific calculation method to ensure safety and effectiveness of these devices. Laboratorians should count slides with full manual review as 1 slide, slides with field of view only review as 0.5 slide, and slides with both FOV and FMR as 1.5 slides.
Examples of Counting Scenarios:
Three scenarios are provided to illustrate how to calculate workload in different situations, including non-gynecologic and automated gynecologic slide preparations.
Manual:
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