BD FocalPoint GS, User Manual, Page: 172 / 242

BD FocalPoint™ GS Imaging System Instrument User’s Manual
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18.7
Selecting Slides for QC Rescreening
This section describes the procedures necessary to ensure that the laboratory is properly
monitoring the performance and results data of the BD FocalPoint™ Slide Profiler. Procedures
are included for meeting CLIA-mandated rescreening requirements in the US.
To ensure that the system and your laboratory processes are performing within the specifications
outlined in the Product Insert, BD recommends that a manual QC rescreen of at least 15% of all
qualified slides be performed. The slides in this enriched group have the highest likelihood of
being abnormal. This enriched population of slides may be used as a substitute for the 10%
random selection of slides that constitutes laboratory quality control review.
In any event, all slides having the action of
QC Review must be rescreened even if the 15%
quota is exceeded. (Refer to the Product Insert for details.)
The following procedure describes how to select slides for a 15% QC rescreening.
1 Obtain the QC Review report (sorted by rank) and Print Summary
— This report should
have been printed at the same time the other slide result reports were printed. If not, a QC
Review report (sorted by rank) can be reprinted for the desired print set. Follow the
instructions in Section 14.2 and in Section 12.
The QC Review report contains a ranked list of all slides selected for
QC Review by the
System, followed by a set of the next highest ranking Review slides.
Note that this report lists a minimum of 25% of all Review slides from the print set. This
percentage ensures that there are enough slides to meet CLIA quality control requirements
after eliminating ineligible slides as described in the next step.
2 Eliminate ineligible slides from the QC Review report — Using the QC Review report
(sorted by rank) as a worksheet, cross off any slides previously called abnormal by the
cytotechnologist. Any slides called unsatisfactory can also be crossed off if they have
already been reviewed twice.
Count the remaining slides on the report and make a note of the number. These are slides
that are eligible for QC review.
3 Calculate the number of slides required for QC rescreening — Note the number of
qualified slides from the Print Summary Statistics report. Calculate 15% of this number to
determine the number of slides required for QC rescreening.
Compare the number of slides required for QC rescreening with the number of
QC Review
slides eligible for QC rescreening. Use whichever group is larger as the rescreening
population.
If the number of eligible QC Review slides is less than the number of slides required for QC
rescreening, go to Step 4. Otherwise, go to Step 5.
NOTE
All eligible slides with a QC Review designation must be
rescreened, even if this exceeds a 15% QC rescreening rate.