Designing an appropriate QC procedure for your lab - 8 Pages

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Catalogue excerpts

QUALITY CONTROL Improving Laboratory Performance Through Quality Control Five simple steps for QC success Designing an Appropriate QC Procedure for Your Laboratory Complete QC solutions for results you can trust

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The Importance of a well-designed 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...

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1. Identify the Quality Specifications for the test • Not every test performs the same • Not every test needs to perform the same • Give poor-performers and high risk tests more QC attention Not every test in the laboratory performs the same way. Some tests for example are the well-known, well liked, laboratory “goodperformers, always showing excellent recovery rates. However, other tests such as the laboratory “poor-performers”, show a lot more inconsistencies in performance, and can often be slightly more problematic and frustrating. “It’s important that you know which tests are your well performing...

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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...

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3. Start and End Patient testing with a QC evaluation Make sure you are testing patient samples in “batches” and are starting and ending patient sampling with a QC evaluation. If you only run QC every morning and one morning you find that your QC is out of range, you may be unaware as to whether the malfunction occurred the previous day or not.Your staff will have to troubleshoot, without knowing if the previous days results have been affected or not, by re-running samples, perhaps unnecessarily. Running QC at the end of the day, assures you that that day’s results are not affected, saving you...

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5. Ensure you are able to recognise and troubleshoot an out-of-control event • The most effective way to recognise errors is to use QC multi-rules • Participate in a ISO 17043 accredited EQA scheme to help recognise errors • Make sure you estimate the magnitude and size of the out of control event, before you correct it There are various approaches for recognising possible out-of-control events. Some labs use a single rule and other labs opt to use QC multi-rules. It is important for whatever rule(s) you use, that you are able to identify errors quickly and effectively, without falsely rejected...

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Participate in an Accredited EQA Scheme QC alone isn’t sufficient for detecting errors and so you should participate in an IS0 17043 accredited EQA scheme. ISO 15189 states that the “laboratory should participate in interlaboratory comparison programmes”. Not only will EQA help you detect errors, it will provide you, the physicians and patients you supply results to, confidence and evidence that you are releasing accurate patient results. Troubleshooting Out-of-Control Events Make sure you estimate the magnitude and size of the out of control event before you correct it. It’s a good idea to take...

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QUALITY CONTROL Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom +44 (0) 28 9442 2413 True third party controls offering complete test menu consolidation Uniquely combining more than 100 parameters conveniently in a single control, laboratories can significantly reduce costs and consolidate without compromising on quality. As true third party controls, unbiased performance assessment with any instrument or method is guaranteed. Online QC software with real-time peer group statistics Compatible for use with the Acusera range of third party controls,...

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