GEM Hemochron 100 User Manual

5 - Quality Control(QC)
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000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
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000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
5 Quality Control(QC)
Global and/or local regulatory agencies recommend that medical and laboratory instrumentation be enrolled
in a quality assurance program adequate in maintaining accurate and reliable system performance.
The GEM Hemochron 100 performs QC checks automatically during system operation to ensure vital
functional and analytical components are operational.
Routine QC testing should be part of a comprehensive quality assurance program. QC testing of the
instrument consists of the following operations:
● Testing system performance using internal Electronic Quality Control (EQC).
● Testing cartridges in accordance with the package insert for each assay using 2 levels of external Liquid
Quality Control (LQC) products.
NOTE: The instrument is calibrated at the manufacturing facility to test and verify all functions. The instrument
is also self-verifying, as all instrument functions are continuously monitored and veried by the instrument
software when a test is run. The instrument does not require additional calibration by the user.
There are 2 types of QC testing:
● EQC testing – During EQC testing, the instrument runs an internal test. This test does not check the
liquid assay function, so a test cartridge and LQC product are not used. For more information, see
“Electronic Quality Control (EQC) Testing” (page 52) .
● LQC testing – This test checks the liquid assay function of the instrument using LQC product and a test
cartridge.
– For information about test cartridges, see “Test Cartridges” (page 16) .
– For information about LQC products, see “LQC Products” (page 53) .
– For information about LQC testing in general, see “Liquid Quality Control (LQC) Testing” (page 53) .
QC of the GEM Hemochron 100 Instrument:
The GEM Hemochron 100 instrument should have 2 levels of QC performed every 8 hours of operation.
This requirement can be accomplished by conducting internal EQC or external LQC testing.
QC of the GEM Hemochron 100 Test Cartridges:
Performance of each lot of GEM Hemochron 100 test cartridges should be validated with 2 levels (Level 1
[Normal] and Level 2 [Abnormal]) of LQC using directCHECK Whole Blood Quality Controls:
● When a new shipment is received, AND
● Once per 30 calendar days thereafter.
Following successful performance validation, the test cartridges will not require any further LQC unless a shift
in clinical results is suspected; however, each institution should follow its own quality assurance policy to
determine LQC testing frequency.
The manufacturer’s acceptable performance ranges for the test cartridges are included with each box of
LQC product.

GEM Hemochron 100 Specifications

General

Brand	GEM
Model	Hemochron 100
Category	Measuring Instruments
Language	English