The FDA guidance, “How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices,” is at www.fda.gov/MedicalDevices/Safety/Alertsand Notices/TipsandArticlesonDeviceSafety/ucm220292.htm.
- All slides with full manual review (FMR) count as one slide (as mandated by CLIA ’88 for manual screening).
- All slides with field of view (FOV) only review count as 0.5 or one-half slide.
- Then, slides with both FOV and FMR count as 1.5 or 1 ½ slides.
- Use these values to count workload, not exceeding the CLIA maximum limit of 100 slides in no less than an eight hour day:
FMR = 1 slide
FOV = 0.5 slide
FMR + FOV = 1.5 slides
Upper limit = 100 slides