There are six contributors when a control performs out of the acceptable limits: Instrument, Reagent, Calibration, User Error, Logistics issue/compromised product, or Control Performance.
- Instrument Issue: Refer to the Instrument Operating Manual for detailed information on troubleshooting a specific instrument malfunction and the required routine maintenance procedure. Check sampling, reagent delivery, mixing, lamp integrity, and reaction temperature. Follow the flow chart below if you suspect an instrument issue is the cause of non-optimal QC performance.
- Reagent Issue: Change the reagent using the same and/or different lot and repeat QC testing. Do patient samples exhibit similar recovery? Refer to the flow chart below if you suspect the reagent is the cause of non-optimal QC performance.
- Calibration Issue: Refer to the Instrument Operating Manual and Calibrator package insert for additional information on calibration procedure and requirements. Recalibrate using the same and/or a different lot of calibrator and repeat QC testing. Refer to the flow chart below if you suspect Calibration is the cause of non-optimal QC performance.
- User Error: Consider if the operator is properly trained on the operation of the instrument, use of the reagent, and control products. Could the problem be replicated by another operator? Is the product stored and handled per the Instruction For Use (IFU)? Refer to the flow chart below to rule out user error.
- Logistics/Compromised Product: Repeat QC testing by using a fresh sample from another shipment. Refer to the flow chart below to rule out a compromised product or logistic issue.
- Control Performance Issues: Refer to the flow chart below to rule out control performance issues once you have ruled out instrument, reagent, calibration, user error, or compromised/logistics problems. If there are assayed values in the control insert, ensure that the lab is using the correct instrument/reagent/method listed in the insert, and compare the QC values to the correct Unity peer data. Please visit myeinserts.com for the latest insert values or call Bio-Rad for the latest peer data and Unity configurations.