BD FocalPoint GS User Manual page 186

BD FocalPoint™ GS Imaging System Instrument User's Manual
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, you can
reprint a QC Review report (sorted by rank) 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 you have enough slides to meet CLIA quality control requirements
after you eliminate 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. You can also cross off any slides called unsatisfactory 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
eligible
slides
population.
You must rescreen all eligible slides with a QC Review designation,
even if this causes you to exceed a 15% QC rescreening rate.
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.
4 Calculate the number of supplemental QC Review slides needed
number of eligible QC Review slides from the number of required slides. This is the number
of slides you must add to your QC review population to obtain the number of slides required
for QC rescreening.
Select the necessary number of supplemental slides from the Review population in order of
rank. That is, select those eligible slides in the top-down order presented on QC Review
report.
5 Determine the number of slides that need QC rescreening from the Process Review
population — If you have not already done so, print a Process Review report for the
selected print set. (To automatically print this report when you print other reports, review the
material in Section 14.1.) Keep in mind that all Process Review slides must have been
screened by a cytotechnologist before being included in a QC review population.
From the Process Review report, following your normal laboratory practices, randomly select
a percentage of the slides for QC review.
186
required
for QC rescreening. Use whichever group is larger as your rescreening
NOTE
for QC rescreening with the number of QC Review
— Subtract the