According to Bachmann and Vandepeole (October 2021) in their article entitled "The 7 Best Practices to Recover from an Out-of-Control Event," when a quality control results has ruled out all the acceptable results, the are considered as an out-of-control event. It means that the measurement system has been failing to perform within its normal analytical specifications, hence a Quality Control Failure. Before resolving the problem, the laboratory must determine the root or cause of this issue, therefore following the step-by-step recommendations from Clinical and Laboratories Standards Institute (CLSI) guideline: Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions, 4th Edition, CLSI guideline C24.1; First, we must detect the analytical measurement system error, then stop reporting the patient results, next is investigate to determine the root cause of the problem, fourth step is implement corrective action, then evaluate impact on previously reported patient results, sixth is take steps to mitigate patient harm, and last is implement preventative action to avoid recurrence of the Out-of-Control Event.

In summary, whatever the cause of any systematic failure encountered, a systematic approach must be implemented by the laboratory, it must be determined by the QC evaluation rules designed to identifyrhe measurement system deviates from normal performance. The laboratory must be able to eliminate all the technical risks and errors which might be faced in the future, hence they can guarantee their patient's results are accurate and free from errors as much as the circumstance allows to.

Reference: Bachmann, L. & Vandepeole, N. (October 18, 2021). The 7 Best Practices to Recover from an Out-of-Control Event. Retrieved September 4, 2023 from https://clpmag.com/lab-essentials/quality-systems/quality-control-programs/the-7-best-practices-to-recover-from-an-out-of-control-event/

According to Tony Badrick (2008) in his journal article entitled “The Quality System”, he stated that when an out of control condition is recognized by a QC process, it is vital to first assess if there is a true problem and not just a false positive, and then properly troubleshoot the system to find a solution to the underlying problem. This necessitates a thorough understanding of both the analytical and control systems. Because not all employees will have the same degree of understanding, training, documentation, and access to some sort of knowledge management are vital. The use of efficient communication tools such as flowcharts and computerized decision support systems can help bridge the gap between the expert and the average user.

The ideal option is to implement control rules with a low likelihood of false rejection while carefully analyzing the failed rules. This will indicate the sort of fault and the most effective troubleshooting steps to take. If there is no written, systematic mechanism in place to analyze the failure and take appropriate action, the entire quality control process is a waste of time and effort.

Reference: Badrick T. (2008). The quality control system. The Clinical biochemist. Reviews, 29 Suppl 1(Suppl 1), S67–S70. Retrived September 4, 2023 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2556587/

It triggers a series of actions to investigate and address the issue. Some steps that may be followed:

1. Documentation: The QC failure is documented accurately and thoroughly. This includes recording the date, time, specific test or process involved, relevant sample or control data, and any observed deviations from the expected results. Documentation is important for traceability, analysis, and future reference.

2. Immediate corrective actions: If the QC failure poses an immediate risk to patient safety or compromises the accuracy of test results, immediate corrective actions are taken. This may involve stopping the affected testing process, notifying relevant personnel, and implementing temporary measures to prevent further occurrences of the failure.

3. Investigation and root cause analysis: A thorough investigation is conducted to determine the root cause of the QC failure. This involves analyzing relevant data, reviewing procedures, examining equipment, and considering potential contributing factors. The goal is to identify the underlying reasons for the failure and understand the factors that led to it.

4. Corrective actions: Based on the findings of the investigation, appropriate corrective actions are developed and implemented to address the root cause of the QC failure. These actions aim to prevent recurrence of similar issues in the future. Corrective actions may include process modifications, equipment calibration or maintenance, retraining of staff, or other necessary interventions.

5. Validation and retesting: Once the corrective actions have been implemented, the affected process or test may undergo validation and retesting to ensure that the issue has been resolved and the quality of results is restored. This may involve running additional QC samples, retesting affected patient samples, or conducting performance verification of the equipment or method.

6. Documentation of actions taken: All actions taken, including the investigation, root cause analysis, and corrective actions, are documented in detail. This documentation serves as an audit trail and provides evidence of the steps taken to address the QC failure.

7. Monitoring and follow-up: The laboratory monitors the performance of the affected process or test to ensure that the corrective actions are effective and sustained over time. Ongoing monitoring and periodic review of QC data are essential to detect any potential recurrence of QC failure or identify new quality issues.

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