Atellica® Solution Troubleshooting QC Step by Step

SIEMENS Healthineers Troubleshooting QC Step-by-Step 1. Verify the following: a. The QC product is correct. b. Ensure sufficient QC volume exists in the QC sample container. c. Check Opened Date. Ensure QC is within the manufacturer’s open stability claim for the assay. IM Analyzer assays- Unload the Reagent Pack and Manually mix the reagents. Check also the # of test left. If <5, can replace reagent pack or try other Reagent packs. Rerun QC. IM Controls Inteliq Immunoassay Plus Control- 5 days stability Inteliq Tumor Marker Control- All Analytes 10 days. CA19-9, B2M- 4 days Inteliq Specialty Immunoassay Control- All Analytes 10 days. iPTH- 7 days InteliQ Cardiac Markers Plus Control LT- 5 days stability InteliQ Homocysteine Control- 5 days stability Lyphochek Immunoassay Plus Control- All Analytes 7 days. Folate and Total PSA- 3 days CH Controls Inteliq Assayed Multiqual Control- 7 days stability. C02- 2 days. Inteliq Urine Chemistry control- 10 days Inteliq Immunology control- 10 days d. Verify autocheck is acceptable. Maintenance- Select IM or Ch Module- SIEMENS Healthineers 2. Examine the calibration: a. For CH Analyzer, verify coefficients and calibrator signals and compare them with previous acceptable calibration. b. If calibration is acceptable, proceed to step 5. Check for Unity Ranges, if comparable. Edit QC Definition and Rerun QC. c. If calibration is unacceptable, recalibrate and then repeat QC. Ensure the Calibrator preparations are correct. a. For IM Analyzer, unload in use reagent pack. Manually mix the reagent pack to ensure the homogeneity of PMP’s. b. Check calibration, compare the Signal Slope and Signal Ratio with previous acceptable calibration. If calibration is acceptable and Comparable, proceed to step 5. c. If calibration is unacceptable, recalibrate and then repeat QC. 3. Perform QC using a new vial of QC material. 4. If QC is now acceptable, remove the QC material. 5. If QC is still unacceptable, replace the reagent pack and repeat QC. If QC is now acceptable, repeat and report patient results. 6. If QC is still unacceptable, review recent QC data for shifts and gradual trending. 7. If QC remains unacceptable, recalibrate and repeat QC. If calibration and QC are acceptable, repeat and report patient results. 8. If QC remains unacceptable: a. If available, calibrate with an alternate calibrator lot and repeat QC. b. If QC is acceptable, repeat and report patient results. c. If an alternate calibrator lot is unavailable, contact the local technical support provider to determine if an alternate lot of calibrator is available. 9. If QC remains unacceptable: a. Perform autocheck. b. If autocheck is unacceptable, contact the local technical support provider for troubleshooting assistance. c. If autocheck is acceptable, continue to step 12 SIEMENS Healthineers 10. If QC is still unacceptable, perform the following: a. If available, install a reagent pack of a different lot. b. Repeat patient samples using both the old and new lot of reagent packs to determine potential QC issues. c. If appropriate, calibrate new lot and repeat QC. If QC is in, repeat patient samples. NOTE: If patient results from the old and new reagent lots correlate closely, a QC issue is most likely impacting the QC recovery. 11. Adjust QC ranges and continue to report patient results based on the following: Acceptable autocheck. – Patient results correlate between the old and new reagent pack lots. – NOTE: If an alternate reagent pack lot is unavailable, call the local Technical support provider to determine if an alternate lot is available. 12. If QC is still unacceptable, contact the local technical support provider for further troubleshooting