Tips and Articles on Device Safety > How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices

How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices

The purpose of this communication is to clarify for laboratories how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices. This communication is intended for cytotechnologists, technical supervisors, and laboratory managers using these systems and addresses how to count fields of view (FOV) and full manual slide reviews (FMR), as well as establishing maximum workload limits. Exceeding the designated maximum workload jeopardizes the ability of device users to detect precancerous and cancerous lesions of the cervix and is a public health risk.

What are the current issues with workload recording and maximum workload limits?
It has been brought to our attention that the current product labeling regarding workload recording for these devices has been difficult to interpret, resulting in variability and lack of standardization in counting methods.

In addition, individual maximum daily workload limits are not being established by the technical supervisor as mandated by CLIA’88. The maximum daily limit specified in each of the device product labeling is only an upper limit and should never be used as an expectation for daily productivity or as a performance target.

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.

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Tips and Articles on Device Safety > How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices