Bayer HealthCare Rapidlab 800 - Manual (Page 78)

1Ć56 Rapidlab 800 Operator's Manual
Calibration Verification
Calibration verification is the measurement of calibration materials to verify that
the calibration of the system has remained stable throughout the patient reportable
range established for your system.
4 While routine QC testing evaluates system
performance in the clinically significant range, calibration verification periodically
checks the upper and lower limits of the reportable range where patient results
occasionally fall.
Use Calibration Verification Material (CVM) to comply with current federal, state,
and local requirements. Your institution should establish its own criteria to evaluate
system performance when verifying calibration.
Verify calibration in the following circumstances:
S when you change reagent lot numbers, unless your laboratory can demonstrate
that the patient reportable range and the control values are not adversely affected
S when you perform major preventive maintenance or replace critical components
on your system
S when controls reflect unusual trends or are consistently outside your laboratory’s
acceptable limits
S when a new system is installed
Analyte Performance Verification
Laboratories introducing new test systems or methods should verify or establish
performance specifications before reporting patient results using the new test
system or method. The APV
SM process that Bayer Diagnostics offers provides you
with data for performance characteristics that you must verify to meet CLIA
requirements. US federal regulations require that each laboratory demonstrates
performance specifications comparable to the manufacturer for the following
characteristics:
4
S accuracy
S precision
S reportable range verification and calibration verification
S reference range verification
The APV process also provides data for the following performance characteristics
that may not be required to meet CLIA requirements:
S control verification
S sensitivity