EDUCATIONAL GUIDE Basic QC Statistics QUALITY CONTROL

Basic QC Statistics qual-ity con-trol - noun A system of maintaining standards in manufactured products by testing a sample of the output against the specification. (Oxford Dictionary; Oxford Universities Press 2013) When testing patient samples the outcome of the result will often be used to diagnose the patient, with an estimated 60 to 70% of all decisions regarding a patient’s diagnosis and treatment based on laboratory test results. As a consequence, the quality of laboratory work is of the utmost importance in ensuring patients are correctly diagnosed and administered the appropriate treatment....

How Often Should We Run QC? How often a laboratory should run QC will be very much dependant on the individual lab and their processes. Many factors will determine this, such as: • The quantity of tests run per day • Which tests are higher risk and have a higher impact if results are erroneous • Experience and competency of laboratory staff • The instrument, reagent and method in use • Available time between QC evaluations • Which assays are more stable compared to others It is often recommended that QC is run at the beginning and end of each analytical run or when a batch of reagents is changed....

Working Examples of Standard Deviation The individual results in example A and example B are significantly different and yet they have the same . SD can be used to distinguish between the sets of data by assessing the variability of the values around the . The SD for example B is much larger than that for example A as the values are more spread out about the . Example A illustrates a set of data with a close distribution around the representing better precision or result reproducibility producing a lower standard deviation. Ranges & Limits Limits for data acceptability are defined using the and...

The following equation is used to measure CV: A CV is a measure of variability and precision. This takes into consideration the magnitude of the overall result and expresses the SD as a percentage of the mean. This calculation will therefore allow comparison of precision at different concentrations of patient testing. The lower the %CV the better the precision. CV = Coefficient of Variation SD = Standard Deviation = Mean result Levey-Jennings Charts Using the and ±3s range a Levey-Jennings Chart can be created for each test. Levey-Jennings Charts will alert a laboratory to any identifiable trends,...

ACUSERA True third party quality controls As a world leading manufacturer of multi-analyte true third party controls, thousands of laboratories rely on Randox to accurately assess test system performance and ultimately empower them with the confidence required to release patient test results. With more than 390 analytes available, the number of individual controls required to cover your test menu is significantly reduced while simultaneously reducing costs, time and storage space. A choice of formats is available, including liquid or lyophilised, which ensures flexibility and suitability for...

ACUSERA 24•7 Interlaboratory Data Management Designed for use with the Acusera range of third party controls, the Acusera 24•7 software helps laboratories monitor and interpret their QC data. Access to an impressive range of features, including interactive charts, the automatic calculation of Measurement Uncertainty & Sigma Metrics and live peer group data generated from our extensive database of laboratory participants, ensures Acusera 24•7 is the most comprehensive package available. • Advanced statistical analysis with automatic calculation of performance metrics including; Sigma, UM, TE &...

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