EDUCATIONAL GUIDE Designing an Appropriate QC Procedure QUALITY CONTROL

Designing an Appropriate QC Procedure It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why QC exists in the first instance. QC is about detecting errors and ensuring that the results you produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm to the patient. We are not examining statistics; we are examining real patients, real results and real lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of utmost importance that each and every laboratory, has a well-designed...

2. Choose Good Quality Control Materials The effectiveness of any QC procedure is underpinned by the quality of the control materials that you choose to use. ISO 15189 recommends that the: “laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”. It is important to note that differently manufactured QC material, will not perform in the same way. It is of utmost importance that you choose the best quality material available on the market, as you may otherwise be putting patients at risk. Look out for the following qualities...

4. Ensure You Know The Characteristics Of Good QC Results In order to recognise a “bad” result, it is important that you are able to recognise the qualities of a “good” set of QC results. In an ideal world, the characteristics of good/normal QC results on a Levey-Jennings chart should; • Fluctuate randomly around the mean for comparison. There should be an equal number of results above the mean as below the mean • Very rarely exceed 3SD; 3 in every 1000 results should be outside 3SD • On the whole be within 1SD • On Occasion exceed 2SD; It is normal for 1/20 results to exceed 2SD It is important...

Recognising out-of-control QC results using a Single rule A laboratory favourite is the 1 result outside 2SD rule. This is a great rule for alarming possible out-of-control events, however, you must be careful as it does have a high false rejection rate. Remember, it is normal for 1/20 results to be outside 2SD! It is important that you also consider the strategy you use when you have a result outside 2SD. Avoid the “repeat, repeat, repeat… got lucky!” tactic. This is not an effective error detection method, as if 2/3 results exceed 2SD you may have a problem at hand that is worth investigating...

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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