Analysis and Solutions to Causes of Out-of-control IQC
发布日期：
2024-04-25
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The "Regulations for Clinical Laboratories in Medical Institutions" clearly states that clinical laboratories should conduct internal quality control (IQC) on the clinical testing items carried out in medical institutions and draw quality control charts. When out-of-control IQC occurs, the cause should be found promptly, corrective measures should be taken, and detailed records should be recorded.


Analysis and Solutions to Causes of Out-of-control IQC





Internal quality control is an important measure to ensure the accuracy of clinical laboratory testing. The laboratory determines the precision and accuracy of laboratory analysis by measuring quality control products every day, and monitors the stability of the detection method or detection system. Once the quality control is out of control, the test results of the day cannot be reported normally, it is necessary to find out the causes for out-of-control IQC as soon as possible and take corrective and preventive measures to avoid similar problems from happening again.

Out-of-control IQC is affected by many factors, including operational errors by laboratory personnel, failure of reagents, calibrators, and quality control products, poor instrument maintenance, inappropriate quality control rules and control limits, and the environment. Once quality control is out of control, it means that the batch of patient specimen reports related to the determination of quality control substances may be invalid. At this time, it is first necessary to identify the cause of the loss of control as soon as possible, then randomly select a certain proportion of patient specimens for re-test, and finally determine whether the previous test results are acceptable based on established standards.



There is no fixed pattern for investigating the causes of loss of control. The general principle is from easy to difficult, from near to far. You can refer to the following order for troubleshooting:


1

Confirm whether the reagents used, calibrators and quality control products are normal


Are the reagents and calibrator/quality control product batch numbers matching?
Whether the reagents and supporting auxiliary reagents have expired
Whether the reagents and calibrator/quality control product have exceeded the expiration date after opening the bottle, causing the reagents to deteriorate or the reagents to evaporate and become concentrated.
Mix the remaining reagents from two bottles of the same batch number or mix the reagents from different batch numbers.
Is the remaining amount of reagents/calibrator/quality control product sufficient?
Are there any bubbles in the reagents/calibrator/quality control product?


2

Operation process review and analysis


Review and analyze whether the operation process on the day out of control was correct to eliminate human error or detect system deviations.
Have there been any changes in personnel?
Are the reagents and calibrator/quality control product locations correct?
Whether the reagent is mixed or the quality control is calibrated according to the reagent instructions.
Whether buffers, washes and other auxiliary products are prepared according to SOP
Has the calibration validity period expired?
Are the target values used correct?
Is the reconstitution process of calibrator/quality control performed in accordance with SOP?
Are the reagents and calibrator/quality control returned to room temperature in advance?
Whether the pipettes used for sampling are calibrated on time
Is the label on the reagent bottle peeled off?
Is the cap of the reagent or calibrator/quality control bottle loose?
Whether the storage location of reagents or calibrator/quality control materials has been changed?
Whether the calibrator/quality control materials have been repeatedly frozen and thawed
Some light-proof items are not stored in light-proof mode


3. After everything is confirmed and there are no abnormalities, perform a quality control retest. If the retest is in control, it is due to accidental factors caused by the detection system or human operation.
4. If the quality control is still out of control, replace it with a new quality control product for verification. If the quality control is under control, the quality control is out of control due to improper storage or contamination of the old quality control product. In some items, the freeze-dried quality control products are unstable after being reconstituted and frozen, and may continuously increase or decrease. Therefore, the storage conditions and period after reconstitution of the freeze-dried quality control products must be confirmed with the manufacturer in advance before use.
5. If it is still out of control, replace it with new reagents and calibrators, recalibrate and perform quality control verification. If the quality control returns to normal, it is caused by reagent contamination or improper storage. The old reagents should be discarded to prevent misuse by other personnel.

6

If it is still out of control, check the instrument to see if it is in normal condition. Re-verify it after the instrument is maintained.



Review and analyze whether the operation process on the day out of control is correct to eliminate human error or detect system deviations.
Have there been changes in personnel?
Are the reagents and calibrator/quality control product locations correct?
Whether the reagent is mixed or the quality control is calibrated according to the reagent instructions
Whether buffers, washes and other auxiliary products are prepared according to SOP
Has the calibration validity period expired?
Are the target values used correct?
Is the reconstitution process of calibrator/quality control performed in accordance with SOP?
Are the reagents and calibrator/quality control returned to room temperature in advance?
Whether the pipettes used for sampling are calibrated on time
Is the label on the reagent bottle peeled off?
Is the cap of the reagent or calibrator/quality control bottle loose?
Whether the storage location of reagents or calibrator/quality control materials has been changed?
Whether the calibrator/quality control materials have been repeatedly frozen and thawed
Some light-proof items are not stored in light-proof mode

7

If it is still out of control, check the lab environment for normal conditions




Does the laboratory temperature and humidity meet the requirements?
Does the laboratory water meet the requirements?
Whether the container for collecting water is clean or whether the dropper or tip of the sample adding pipette is clean
Whether the laboratory environment is clean and can effectively avoid cross-contamination
8. If none of the above solutions solve the problem, it may be caused by the instrument or reagents. Contact the manufacturer of the instrument or reagents for professional technical personnel to assist in solving the problem.




In addition, the laboratory should also regularly review the quality control data to see if there is any trend in the quality control data that is about to get out of control. If so, corrective and preventive measures should be taken in time to prevent the occurrence of out-of-control IQC.





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