College of American Pathologists

  CAP Advocates for FDA Clarification of Cytology
  Slide Review Methodology


Posted August 31, 2010

Attention CAP Accredited Cytology Laboratories:

The College of American Pathologists continues to advocate for laboratories with the numerous Federal agencies regulating clinical laboratories in the United States. After extensive collaboration with FDA regulators, CAP received the following clarification regarding the acceptable method of counting slides for cytology workload recording, especially when using image-guided screening instruments.

Workload calculations for slides reviewed with image-guidance differ from those undergoing manual review and may vary among manufacturers. Laboratories should follow Food and Drug Administration (FDA)-approved manufacturer’s instructions for workload calculations and must ensure that CLIA requirements are fulfilled. Maximum workload limits for image-assisted instruments may not exceed those established by the manufacturer. Manually reviewed slides each must be counted individually, as a single slide, in addition to being counted as an image-assisted slide.

Recently, the FDA provided additional information to clarify this issue further for clinical laboratories using approved “semi-automated gynecologic cytology screening devices.” The following excerpt of the FDA statement involves image-assisted screening:

“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 FocalPoint™ 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 the following values to count workload, not exceeding the CLIA maximum limit of 100 slides in no less than an 8-hour day”.
    • FMR = 1 slide
    • FOV = 0.5 slide
    • FMR + FOV = 1.5 slides
    • Upper Limit = 100 slides

Review the complete communication from the FDA.

Thank you for your support and commitment to laboratory clinical excellence. If you have questions, please contact the CAP Customer Contact Center at 800-323-4040 option 1, then 4, or email us.