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Troubleshooting QC Errors

Troubleshooting QC Errors

Troubleshooting QC Errors

Product catalog summary
Troubleshooting QC Errors

Introduction:
Quality Control (QC) errors are common in laboratories, and effective troubleshooting procedures are essential to minimize their impact. This guide provides a structured approach to handling out-of-control QC events.

Steps for Troubleshooting QC Errors:
  1. Put the Problem into Perspective: Evaluate the magnitude of the out-of-control event before taking corrective actions. ISO 15189 requires evaluating patient samples tested after the last QC event.
  2. Review Levey-Jennings Charts: Use these charts to identify whether the error is systematic or random. Systematic errors show a bias in control values, while random errors vary unpredictably.
  3. Relate Error Type to Possible Causes: Systematic errors may be due to changes in reagents or calibration, while random errors could result from issues like bubbles in syringes or power fluctuations.
  4. Implement Corrective Actions: Make one change at a time, monitor its effectiveness, and document the solution. Common corrective actions include instrument maintenance and recalibration.

QC Multi-Rules:
QC multi-rules help differentiate between systematic and random errors. Key rules include:
  • 12s Rule: A warning for potential random or systematic errors.
  • 13s Rule: Indicates unacceptable random error or a large systematic error.
  • 22s Rule: Suggests systematic error when two results exceed 2s on the same side of the mean.
  • R4s Rule: Represents random error with a 4s difference within a run.
  • 7X, 8X, 9X, 10X, 12X Rules: Indicate systematic error when multiple results are on the same side of the mean.

Conclusion:
Effective troubleshooting procedures are crucial for laboratories to manage QC failures. Randox Laboratories offers a range of multi-analyte controls and software solutions to support laboratories in maintaining QC standards and meeting ISO 15189:2012 requirements.
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Catalog excerpts

Troubleshooting QC Errors-1

EDUCATIONAL GUIDE Troubleshooting QC Errors QUALITY CONTROL

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Troubleshooting QC Errors 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? Your QC Has Failed, What Do You Do Next? 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...

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Troubleshooting QC Errors-3

2. Review Your Levey-Jennings Charts To Understand The Type Of Error That Has Occurred There are two types of analytical errors: Systematic Errors Random 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. Standard Deviation Standard...

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Using QC Multi-Rules To Identify Systematic & Random Error You can use QC multi-rules to differentiate between systematic and random error. +3s Standard Deviation Standard Deviation 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. Any QC result outside +/-3s breaks this rule. This rule...

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Troubleshooting QC Errors-5

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 1. Change or failure in light source 2. Major instrument maintenance 3. Failure in sampling system 4. Change in temperature 5. Failure in reagent dispense system 6. Change in reagent formulation 7. New reagent...

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Troubleshooting QC Errors-6

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...

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Troubleshooting QC Errors-7

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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Troubleshooting QC Errors-8

Copyright © 2019 Randox Laboratories Ltd. All rights Reserved. VAT number: GB 151682708. Product availability may vary from country to country. Some products may be for Research Use Only. For more information on product application and availability, please contact your local Randox Representative.

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