Quality Assurance On The Bd Focalpoint™ Slide Profiler; The Quality Assurance Program - BD FocalPoint GS User Manual

19 Quality Assurance on the BD FocalPoint™
Slide Profiler
US Clinical laboratories that report cytology test results must comply with all quality control (QC)
requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88).
Specifically, 42 CFR 493, Subpart K specifies that for tests of high complexity, such as cytology,
both general quality control requirements and quality control requirements, must be in
compliance with CLIA '88.
BD developed a Comprehensive Quality Assurance Program to ensure that the BD FocalPoint™
Slide Profiler produces accurate and reliable test results. Performing the quality control
procedures specified in this Program enable you to comply with the requirements of 42 CFR 493,
Subpart K insofar as they apply to the BD FocalPoint™ Slide Profiler. This Program is designed
to be supplemental to all other requirements of Subpart K. Note that the BD FocalPoint™ Slide
Profiler is not intended to be used as a substitute method for selecting cases for QC review from
patients or groups of patients that are identified as having a high probability of developing
cervical cancer based on available patient information (42 CFR Part 493, Subpart K, §493.1257
(d)(1)(i)).
This section contains the QC procedures for the BD FocalPoint™ Slide Profiler Comprehensive
Quality Assurance Program. Refer to the following sections:
• The Quality Assurance Program (Section 19.1) gives an overview of the BD FocalPoint™
Slide Profiler Comprehensive Quality Assurance Program.
• Selecting Slides for QC Rescreening (Section 19.2) contains descriptions of 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 '88-mandated rescreening requirements and monitoring the Slide Rejection Rate.
• Training Records (Section 19.4) provides instructions about documenting the training
procedures that were performed in your laboratory.
• System Performance Verification (Section 19.5) contains the procedures necessary to print
reports that document the performance of the automated System Integrity tests and reports
that document any system failures.
19.1

The Quality Assurance Program

The Quality Assurance Program ensures continuous optimum performance of the
BD FocalPoint™ Slide Profiler in your laboratory, and aids compliance with the applicable quality
control requirements of CLIA '88.
This program consists of three phases: pre-installation, installation, and post-installation (see
Figure 19-1). These three phases of the BD FocalPoint™ Slide Profiler Quality Assurance
Program are discussed in detail in the following sections.
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