Quality Control - Abbott Afinion ACR Anleitung

QUALITY CONTROL

Quality control testing should be done to confirm that your Afinion
Analyzer System is working properly and providing reliable results.
Only when controls are used routinely and the values are within
acceptable ranges can accurate results be assured for patient samples.
It is recommended to keep a permanent record of all quality control
results. The Afinion Analyzer automatically stores the control
results in a separate log. Consult the Afinion Analyzer User Manual.
Choosing control material
Afinion ACR Control from Abbott is recommended for routine
quality control testing. Consult the Afinion ACR Control Package
Insert.
If controls from another supplier are used, the precision must be
determined and acceptable ranges for the Afinion Analyzer System must
be established.
Frequency of control testing
Controls should be analysed:
• anytime an unexpected test result is obtained.
• with each shipment of Afinion ACR test kits.
• with each new lot of Afinion ACR test kits.
• when training new operators in correct use of Afinion ACR and the
Afinion Analyzer.
• in compliance with national or local regulations.
Verifying the control results
The measured value should be within the acceptable limits stated for
the control material. Consult the Afinion ACR Control Package
Insert.
If the result obtained for the control is outside the acceptable limits, make
sure that:
• patient samples are not analysed until control results are within
acceptable limits.
• the control vial has not passed its expiry date.
• the control vial has not been used for more than 8 weeks.
• the control vial and Afinion ACR Test Cartridges have been stored
according to recommendations.
• there is no evidence of bacterial or fungal contamination of the control
vial.
Correct any procedural error and retest the control material.
If no procedural errors are detected:
• Retest the control material using a new control vial.
• Examine the laboratory's quality control record to investigate the
frequency of control failures.
• Ensure that there is no trend in out-of-range quality control results.
• Patient results must be declared invalid when controls do not perform
as expected. Contact your local supplier for advice before analysing
patient samples.
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