Troubleshooting QC errors - 8 Pages

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Catalogue excerpts

QUALITY CONTROL Improving Laboratory Performance Through Quality Control Five simple steps for QC success Your QC has failed, what do you do next? Complete QC solutions for results you can trust

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Your QC has failed, what do you do next? So you ran QC this morning and realised that one of your analytes has been flagged as “out-of-control”, what do you do next? Do you ignore the warning and continue patient testing, repeat the control until it’s within range or do you halt patient testing and investigate the source of the error? When it comes to troubleshooting QC errors, unfortunately there is no easy path to take. However, it’s important that you have standard operating procedures in place, outlining what to do in the event of an out-of-control error. Errors occur in laboratories all over...

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1. Put the problem into perspective before you begin troubleshooting • Outline what you recognise as an out-of-control event • It’s important to estimate the magnitude and size of the out-of-control event before you attempt to correct it. Using QC multi-rules is a great way to ensure sensitive error detection, whilst keeping the false rejection rate low. Make sure you outline what you recognise as an out-of-control event that warrants corrective action to take place. In the event that a series of QC multi-rules have been broken, you should halt patient testing immediately until the problem has...

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2. Review your Levey-Jennings charts to understand the type of error that has occurred There are two types of analytical errors: Random Errors Systematic Errors Both of these types of errors can be recognised on a standard Levey-Jennings chart and by using QC multi-rules. Identifying the type of error will help you relate the error to a possible cause. Systematic Error Systematic errors create a characteristic bias and can be identified by a change in the mean of control values. The change in the mean may be either a gradual trend or an abrupt shift in control results. >+3 Standard Deviation Standard...

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Using QC Multi-rules to Identify Systematic and Random Error You can use QC multi-rules to differentiate between systematic and random error. +3s Standard Deviation Standard Deviation Rule 12s: This is a warning rule that is broken when a single control observation is outside the +/-2s limits.This rule warns that either a random or systematic error is present in the test system. If no other unacceptable results are apparent in the test system, it must be assumed that this is simply a random error and no further troubleshooting action is necessary. Standard Deviation Standard Deviation Rule 22s:...

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3. Relate the type of error to possible causes Ask yourself questions in order of likely relevance and review the most common solutions to the problem. Dependent on whether you have identified a systematic or random error in your system, this can help you determine the possible root cause of the error. See below for some common causes of systematic and random errors. Systematic Error: Shift Change or failure in light source Change in reagent formulation Major instrument maintenance Failure in sampling system Recent calibration Failure in reagent dispense system Systematic Error: Trend Slowly deteriorating...

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4. Implement corrective actions, check the effectiveness of the corrective actions and document the solution Once you have identified possible causes of the out-of-control event, implement any necessary corrective action. It’s important that you implement only one change at a time and monitor the improvement of that change on your QC and patient results. It’s important that you document the solution and learn from your previous laboratory failures. Put procedures in place to prevent any errors from reoccurring. Remember that a single unacceptable result is most likely due to random error. In this...

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QUALITY CONTROL Randox Laboratories Ltd, 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, the...

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