Accreditation is an essential element of a clinical laboratory's long-term success. With a variety of U.S. and international regulatory bodies setting requirements, figuring out how to meet all the accreditation and licensing criteria can sometimes cause us to lose sight of the why.
Calibration verification is a requirement of CLIA and ISO 15189. CLIA (and CAP as well) specifies that it must be done a minimum of every six months. Other factors can trigger more frequent verification. Meeting this standard means analyzing three samples in duplicate, twice a year on each instrument. Yet, the effort is invaluable. Calibration verification is about much more than checking off a box on a semi-annual to-do list. It means you can be confident that patient results are accurate throughout an instrument’s life in your lab.
Ensure correct performance
Before you put a new instrument into service, linearity and calibration verification assays allow your laboratory to compare actual performance to that claimed by the manufacturer. This gives you an opportunity to address issues before the laboratory directory accepts the instrument.
Confirm full range of coverage
Once the instrument is installed, ongoing calibration verification demonstrates that the range established at the time the instrument was accepted is maintained. Since many of today’s clinical methods are calibrated with a 2-point calibrator, it’s important to look at the entire reportable range.
Running quality control (QC) materials between testing events is an effective way to check calibration validity and assay stability.
Gain valuable troubleshooting data
When a system doesn’t perform as expected, calibration verification can help you troubleshoot. If QC samples fail to recover, you likely rerun the assay expecting better results. If that doesn’t happen, you may recalibrate. What if it fails again? At that point, calibration verification is the only way to challenge the reportable range and get an idea of where the problem lies.
Capture accurate results—consistently
Calibration verification is a proven method to continuously monitor performance and maintain high quality standards, no matter how many tests your lab performs. It ensures the values you receive are the ones you expect.
Commercial calibration verification kits, like those offered by LGC Maine Standard’s VALIDATE® product line, reduce the need to source patient samples and challenge the reportable range through a more widely accepted five levels. Additionally, each test provides enough product for two test runs, and more for troubleshooting.
Find out more about how calibration verification can improve the accuracy of results
Download our white paper: Why Perform Calibration Verification? by clicking on the button below.
You can also contact one of our specialists to discuss how linearity and calibration verification can improve your lab’s proficiency testing. To speak with an LGC Maine Standards Technical Support expert, call 1-800-377-9684.
Chris Cotreau is a Senior Product Manager at LGC Clinical Diagnostics.