Quality Control (QC) testing of the GEM Hemochron 100 (GH100) consists of EQC and LQC.
- Electronic QC (EQC) and Electronic System Verification (ESV):
- Set to automatically run every 8 hours GH100 is powered on and operational.
- Operators do not need to manually run EQC unless it fails or the GH100 was powered off.
- EQC testing includes 3 phases of testing for testing the system performance and verifying system temperature: ESV, EQC Level 1, and EQC Level 2.
- All 3 phases of EQC must pass for patient testing. ESV is also automatically performed after powering on the instrument and before patient and LQC testing.
- Set to automatically run every 8 hours GH100 is powered on and operational.
- Two levels of Liquid QC (LQC):
- Level 1 (normal) and Level 2 (abnormal) LQC are used to validate the performance of the GH100 test cartridges. Acceptable LQC result ranges are included with each GH100 Hemochron QC product (package insert located in the LQC box).
- At a minimum, each lot of GH100 ACT-LR test cartridges should be validated for performance with both levels of LQC:
- When a new shipment of test cartridges is recieved, and
- Every 30 calendars days in a rolling period from the last time LQC was performed (i.e., the start timedue will be based on the start time of the last successfull LQC test). Both levels must pass to proceed with patient testing.