Controls; Internal Quality Control; Internal Electronic Quality Control Label - QBC Diagnostics Star Operators & Service Manual

Controls

Internal Quality Control

The QBC STAR Centrifugal Hematology System has multiple built-in-quality control (QC) systems that maintain the overall
system integrity and the quality of the test results it produces. The QBC STAR System has fi ve internal quality control
elements:
1 Factory calibration. System calibration is set during manufacture and cannot be altered by the user.
2 Instrument self-test. This test assures that each time the instrument is turned on, the computer, memory, optics,
and motors are fully functional. Should you choose to leave the system on continuously, the test will automati-
cally be repeated every 8 hours. A tri-level internal electronic quality control label (electronic QC label), designed
to simulate 3 hematology specimens (simulating low cell counts, normal cell counts, and elevated cell counts)
tests the system's optics against values established at the time of manufacture. At the end of the self-test. the
instrument prints the hematology values obtained from reading the electronic QC label. The hematology values
may be plotted to evaluate for shifts or trends in the data. The instrument will fl ag any results that are outside
the set limits, print an error code, and automatically shut down operation of the instrument until the problem
is corrected and a valid self-test is performed.
3 Electronic QC (during each sample run). The tri-level electronic QC label is re-checked during each sample
run. The instrument will recognize any results that are outside the set electronic QC limits, print an error code,
and automatically shut down operation of the instrument until the problem is corrected and a valid self-test
is performed. Additional built-in checks include tests for proper centrifuge speed, optical focus, and internal
temperature. When these quality control checks are successfully completed, the status of the electronic QC is
printed on the patient record as "Electronic QC: Passed."
4 Sample Preparation QC (during each sample run). The built in checks confi rm that the QBC STAR tube has not
been previously processed and is correctly assembled. Tests confi rm that the cap is present, the tube assembly
is the proper length, the fl oat is present and the correct length, and the tube is fi lled with the correct amount
of blood.
5 Reagent QC (during each sample run). These built-in checks evaluate reagent integrity using the data from the
optical scan. This includes tests for fl uorescent signal intensity, interface sharpness, and the reproducibility of
scans around the tube.
Results are reported only if all of the internal quality control requirements have been satisfi ed.

Internal Electronic Quality Control Label

An internal quality control label, designed to simulate 3 hematology specimens, is automatically read every 8 hours as
part of the instrument self-test. The instrument prints the hematology values obtained from reading the tri-level electronic
QC control label at the end of the self-test. These values are available to plot and evaluate shifts and trends. The label is
also read with each patient sample run.
The instrument compares the electronic QC values measured (during self-test and during patient sample runs) to factory
established limits. Recovery of any value outside of the established limits will result in an instrument shutdown until the
problem is corrected and a valid self-test is performed. The internal electronic QC label tolerances are shown in the table
below.
L–000867(A)
5 – Performance and Limitations
5–5