# RAND®X QUALITY CONTROL QC Multi-rules are designed and used to minimise false rejections and maintain a high rate of error detection. There are six main rules used to determine if results from a run of patient samples should be accepted or rejected, based on the performance of control materials against the rule criteria. Different combinations can be applied depending on the number of controls in use, total allowable error and the instrument in use. The flow chart below is often used to determine if a run should be accepted or rejected. Q Rule 4 (4 results exceed 1SD) This rule is applied both within and across runs. The 41S rule is violated within run when four consecutive control results for the same control exceed the mean by either + 1S or -1S. The rule is violated across run when four consecutive control values for different levels of control exceed the mean by either +1S or -1S. The 41S rule detects systematic error rather than rejecting the run violation of this rule can indicate that instrument maintenance or calibration should be carried out. Rule 10x (10 results same side of the mean) This rule is violated if ten consecutive control results regardless of level fall on the same side of the mean. The rule detects systematic error and can be applied both within and across runs. Violation of this rule may not require rejection of the run but rather indicate that instrument maintenance or calibration is needed. The 10x rule can be modified to 7, 8, 9 or 12 consecutive results on the same side of the mean, each giving varying levels of sensitivity to systematic bias. Sources of random error • Power supply • Pipetting technique • Contamination • Bubbles in reagent/sample pipette system • Inappropriate storage • Poor operator technique Sources of systematic error • Deterioration of reagents, calibrator or controls • Instrument may need recalibrated • Poor calibration • Accumulation of debris on the instruments sample/ reagent pipettes • Change of reagent batch or reagent formulation • Instrument error or failure ACUSERA® ACUSERA® For optimum performance and advanced analytical capabilities use Randox third party controls in combination with Acusera 24^7 Live Online. Acusera 24^7 Live Online is an interlaboratory data management and peer group reporting package designed to monitor analytical performance, interpret QC results and improve the overall effectiveness of quality control processes. • Online access anytime, anywhere • Automatically analyse QC data and apply user defined QC rules. • Unique dashboard interface displaying any QC tests which have fallen outside performance limits in the last 7 days. • Peer group data generated from up to 20,000 laboratory participants. • Peer group data uniquely updated every 24 hours • I nteractive Levey-Jennings and Histogram charts capable of combining multiple parameters, lots and instruments • Comprehensive reports enabling exceptional data analysis and review • Capable of importing QC data direct from your instrument or LIMs Controls Available Clinical Chemistry Immunoassay Specific Proteins Maternal Screening Tumour Markers Lipids Urine Chemistry Cardiac Blood Gas Coagulation Glycated Haemoglobin (HbAlc) Therapeutic Drug Monitoring Urine Toxicology Speciality/Research With 30 years experience in quality control; excellent choice, stability and performance is guaranteed. RAND®X QUALITY CONTROL Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www.randoxqc.com