Hologic ThinPrep Imager Duo - Page 18

MAN-08723-001 Rev. 001 page 14 of 28
Laboratorians should use the following method when calculating workload:
• All slides with Fields of View (FOV) only review count as 0.5 or ½ slide
• All slides with full manual review (FMR) using the Autoscan feature count as 1 slide (as mandated by CLIA’88 for
manual screening)
• 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.
The ThinPrep
®
Imaging System limit of 100 slides in an 8-hour workday includes the following:
• Screening 22 Fields of View
• Full manual slide review using the Autoscan feature
• Review clinical history
• Record results and triage appropriately
An example of workload scenario for ThinPrep Pap slides using the ThinPrep Imaging System:
100 FOV review only = 50 slides (100 x 0.5 = 50)
30 FOV review + FMR = 45 slides (30 x 1.5 = 45)
Total number of slides screened = 95 (50 FOV only and 45 FOV + FMR)
• Note: ALL laboratories should have a clear standard operation procedure for documentation of their method of workload
counting and for establishing workload limits.
• It is the responsibility of the Technical Supervisor to evaluate and set workload limits for individual cytotechnologists
based on laboratory clinical performance.
According to CLIA ’88, these workload limits should be reassessed every six months.
For less than an 8-hour workday, the following formula must be applied to determine the
maximum number of slides to be reviewed during that workday:
(
Number of hours examining slides
) x 100
8
The manual workload limit does not supercede the CLIA requirement of 100 slides in a 24-hour
period in no less than an 8-hour day. Manual review includes the following types of slides:
• Slides reviewed on the ThinPrep Imaging System using the Autoscan feature
• Slides reviewed without the ThinPrep Imaging System
• Non–gynecologic slides.
When conducting manual review, refer to the CLIA requirements for calculating workload limits.
G.6 THINPREP IMAGING SYSTEM USE WITH THINPREP 5000 PROCESSOR
A study was conducted to estimate the Positive Percent Agreement (PPA) and Negative Percent
Agreement (NPA) for Imager-assisted review as compared with manual review of specimens
processed on the ThinPrep 5000 processor.
FMR = 1 slide
FOV = 0.5 slide
FMR + FOV = 1.5 slides
Upper Limit = 100 slides