GEM Hemochron 100 - QC Lockout

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
5.2 Liquid Quality Control(LQC) Testing
An LQC test checks the assay function of the instrument. During this test, the instrument prompts the
Operator to insert a test cartridge into the instrument and apply the LQC product.
CAUTION: If the LQC test feature is required (Yes), the instrument will be required to run LQC tests at
regular intervals. The factory default setting for this feature is not required (No) but can be changed
using CCM. The manufacturer recommends that it be required (Yes). The decision to require (Yes) or
not require (No) this feature shall be determined by and is the responsibility of the each institution.
BIOHAZARD: Test cartridges are for single-use only, do NOT reuse. All used test cartridges and
LQC products should be considered as potentially infectious. Strictly adhere to the institution’s policies
for the proper handling and disposal of biohazardous materials.
LQCProducts:
directCHECK Whole Blood Quality Controls are the recommended LQC products for the GEM Hemochron
100 instrument. The LQC product and test cartridge must match the type of LQC test that needs to be run.
See Table 3 (page 19) .
Acceptable performance ranges for the LQC product are included in the package insert. For assistance,
contact your local representative.
LQCTest Results:
The test result of an LQC test is either Pass or Fail. If the ACT value is within the expected performance
range, the test passes. If the ACT value is not within the expected performance range, the test fails. When an
LQC test is complete, Operators can view details of the test result.
5.3 QCLockout
The QC lockout feature prevents Operators from running a patient test if the instrument does not meet the
performance range. There are 2 types of lockout:
● Patient Test Lockout – This feature prevents Operators from running patient tests. This occurs when a
QC test fails or when an interval expires.
● QC Test Lockout – This feature prevents Operators from running additional QC tests after the maximum
allowed number of failures have been exceeded.