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CAP Home > CAP Reference Resources and Publications > CAP TODAY > CAP TODAY 2010 Archive > FDA guidance
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  FDA guidance

 

CAP Today

 

 

 

October 2010
Feature Story

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/TipsandArticleson¬≠DeviceSafety/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
 

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