BD FocalPoint GS, User Manual, Page: 185 / 242

Quality Assurance on the BD FocalPoint™ Slide Profiler
185
• system performance verification and laboratory process monitoring
• routine maintenance
• review of scan failures (See Section 21)
• start up, shut down, and troubleshooting procedures
• comprehensive Quality Assurance program
A training form must be completed and signed by each person who successfully completes the
BD FocalPoint™ Slide Profiler training. The customer training staff person who provides your
training will provide copies of the necessary training documents.
19.1.3 Post Installation Phase
Once your laboratory begins routine use of the BD FocalPoint™ Slide Profiler, you enter the
post-installation phase. During this phase you must periodically monitor the performance of the
System and the slide preparation processes that can affect its performance. BD recommends
that you monitor the following aspects of the BD FocalPoint™ Slide Profiler performance:
•
System Integrity Monitoring — The quality of the automatic screening performed by the
BD FocalPoint™ Slide Profiler is assured by periodic monitoring of all major components.
Through the process called System Integrity (SI), the performance and calibration of all
illumination, image collection, and processing systems are verified. SI testing is performed
before the first tray and after each succeeding tray is processed. System Performance
Verification (Section 19.5) and Section 23 provide information about SI and how to document
SI performance daily.
• Process Integrity Monitoring — To ensure that the system and your laboratory process are
performing within the parameters defined in the Product Insert, BD periodically monitors
system performance.
• Slide Rejection Rate Monitoring — Monitor the usage statistics periodically to determine the
number of slides rejected by the BD FocalPoint™ Slide Profiler as unsuitable for scanning.
This information may be used to observe any increase in slide rejection due to specific slide
preparation parameters. Procedures for monthly monitoring of the Slide Rejection Rate are
provided in the next section, Selecting Slides for QC Rescreening (Section 19.2).
19.2
Selecting Slides for QC Rescreening
This section describes the procedures necessary to ensure that your 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 U.S.
To ensure that the system and your laboratory processes are performing within the specifications
outlined in the Product Insert, BD recommends that you perform a manual QC rescreen of at
least 15% of all qualified slides. 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 you exceed
the 15% quota. (Refer to the Product Insert for details.)