Training Records; System Performance Verification; Si Overview; Test Information Reporting - BD FocalPoint GS User Manual

19.4

Training Records

Training will be conducted by BD. Copies of training documentation for all staff will be made
available to the laboratory for their files.
19.5

System Performance Verification

This section describes the BD FocalPoint™ Slide Profiler automated quality control monitoring
system, System Integrity (SI), and the procedures necessary to print reports containing the
results of the SI tests and any system messages.
19.5.1

SI Overview

The quality of the automatic screening performed by the BD FocalPoint™ Slide Profiler is
assured by periodic, comprehensive monitoring of all components. Through a process called
System Integrity (SI), all motion, electrical, illumination, image collection, and image processing
components are verified. SI tests are performed before the first tray and after each succeeding
tray is processed. If any component fails a SI test, the slide results for the previous tray are
invalidated. The system next attempts to recalibrate itself, and, upon successful recalibration,
begins processing the next tray. If an SI test fails, a recovery process is automatically invoked. SI
is repeated up to four times after recalibration. Continued failure of one or more of the System
Integrity tests causes the instrument to stop processing.
SI also monitors any drift in the operating parameters and may initiate automatic recalibration to
ensure that calibration is performed well before calibration limits are exceeded. When this
occurs, slide results for the previous tray are not invalidated.
For more information about SI, see Section 23.
19.5.2

Test Information Reporting

During normal operation, the system logs all calibration and SI results and slide processing data
into the system log. Data is included for the following:
• Automatic calibration results and parameters
• SI test results and comparison to limits
• Slide scanning results and parameters
The system log documents all system quality control testing and provides data for process
monitoring and trend analysis.
To document instrument quality control, your laboratory must keep a record of SI results. The
procedure for tracking SI results is described under the heading Section 19.5.3. Individual test
failures are always recorded in the system log. Use the System Message command to print a list
of any failures recorded in the system log. The procedure for printing the system messages is
described under the heading Section 19.5.4.
Quality Assurance on the BD FocalPoint™ Slide Profiler
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