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19.1.2

Installation

When the pre-installation phase is completed, BD ships your BD FocalPoint™ Slide Profiler. A
BD-designated representative installs the system and performs all required calibration and
performance verification tests. Figure 19-3 illustrates the activities that take place during the
Installation phase.
Field Service or authorized distributor
Once the BD FocalPoint™ Slide Profiler has been calibrated and passed all the requisite
performance verification tests, a representative of your laboratory will accept and document the
installation of the system.
LPCA Procedures
After installation, a BD service representative performs the Laboratory Process Compatibility
Assessment (LPCA) procedure, which assesses the compatibility between your slide preparation
process and the BD FocalPoint™ Slide Profiler. This procedure is performed for each
preparation type/coverslip type combination (for example, BD SurePath™ w/plastic coverslip)
that your laboratory processes.
If it is determined that elements of your slide preparation process are not compatible with the
BD FocalPoint™ Slide Profiler, the BD service representative will recommend changes to your
process to ensure full compatibility. Figure 19-4 illustrates the elements of the LPCA process.
Quality Assurance on the BD FocalPoint™ Slide Profiler
Ship
BD FocalPoint
System
Performed by BD Diagnostics
Install System
Calibrate system, check SI, and
Calibrate and
qualify system
Qualify
System
LPCA Modify
System, If
Required
System Operational
Figure 19-3 – Installation phase activities
Laboratory Documents
Acceptance of System
183

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