Quality Control testing of the ROTEM delta system consists of regular performance of Internal / Equivalent Quality Control and External / Liquid Quality Control.
DAILY: Internal or Equivalent Quality Control
- EQC/Internal QC is evaluated for accuracy daily on each day of use of the instrument. A printout is REVIEWED, SIGNED and FILED by the operator who evaluated the data.
- Consists of a continuous self-monitoring procedure when the system is powered on, as well as automatic monitoring and information during routine measurement operation of the system.
- Is the primary quality control mechanism for the ROTEM delta. It validates the proper functioning of the axis on each channel and the performance of the instrument optics.
When Internal Quality Control is out-of-range the following procedure is to be followed:
- Re-evaluate the service value that is out-of-range. Reasses to determine if the value falls within range is the first acceptable corrective action.
- If any value is out of range and cannot be quickly remedied, then determine if the values are affecting all channels or if the value is only impacting one particular channel.
- If it can be determined that a single channel is involved, refer the problem to the Super User, Point of Care Testing Service, or call Rotem® Technical Support.
- Document all corrective actions taken.
- Only use channels that have passed the Service Value check for patient testing.
WEEKLY: External or Liquid Quality Control
- ROTROL N and ROTROL P are the required external control materials for the ROTEM system and run as performance tests to identify potential problems with:
- Reagents
- Consumables (tips, cups)
- Pipette Performance
- User Technique
- Both ROTROL N and P controls are run at least once per week (every Wednesday) of use of the instrument for clinical purposes and on any of the following occasions before continued use of the instrument in patient testing:
- After preventive maintenance is performed on the instrument.
- Whenever a new shipment or lot number of reagent is received.
- Whenever a new shipment or lot number of quality control is received.
- Whenever a value from the service menu is out-of-range and cannot be corrected.
- When External Quality Control Passed, a printout is REVIEWED, SIGNED and FILED by the operator who evaluated the data.
- External QC results must produce acceptable results that fall within the ranges for any reportable parameter. QC is lot-specific. Refer to the package insert of the QC material in use for valid reference ranges.
- Target values for the specific ROTROL lots should enter automatically when scanning the barcode for the ROTROL tracking.
- If the barcode does not read with the barcode scanner, enter the target values of the selected tests for each new ROTROL lot manually.
- If no target values are manually entered, the lot specific QC results must be compared with the Quality Certificate in the package insert of the concerned lot.
When External Quality Control is out-of-range the following procedure is to be followed:
- Repeat measurement on the affected channel using same vial. If the quality control result on the affected channel is within range no further testing needed. Channel is okay to use for patient testing.
- If quality control result remains out-of-range after repeating on the same vial, re-run the controls with new vials.
- If quality control result is still out-of-range after the repeat, the controls may be repeated with a new box of control.
- If quality control results remains out-of-range, do not use the affected channel(s) for patient testing. Refer the problem to the Super User, Point of Care Testing Service, or call Rotem® Technical Support.