instrument to instrument comparison
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With the standard below, our system needs to iron out the steps for comparing multiple POCT instruments on the same platform (istats and epocs) to comparable laboratory methods. Using QC material may be the easiest choice. But if you have over 100 iSTATs with varying testing options, how is this being carried out in a large system?
**REVISED** 06/04/2020
**REVISED** 06/04/2020
| COM.04250 | Comparability of Instruments and Methods - Nonwaived Testing | Phase II
| | If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments and methods are checked against each other at least twice a year for comparability of results. NOTE: This requirement applies to tests performed on the same or different instrument makes/models or by different methods, even if there are different reference intervals or levels of sensitivity. It includes primary and back up methods used for patient testing. The purpose of the requirement is to evaluate the relationship between test results using different methodologies, instruments, or testing sites. The laboratory must establish a written procedure for this check that includes acceptance criteria. The following types of materials may be used to generate data for comparability studies: ● Patient/client specimens (pooled or unpooled) are preferred to avoid potential matrix effects ●
Quality control materials for tests performed on the same instrument platform, with both control materials and reagents of the same manufacturer and lot number. ●
Alternative protocols based on quality control or reference materials for cases when availability or pre-analytical stability of patient/client specimens is a limiting factor. The materials must be validated (when applicable) to have the same response as fresh human specimens for the instruments and methods involved. This requirement only applies when the instruments/reagents are producing the same reportable result. . Evidence of Compliance: ✓ Written procedure for performing instrument and method comparison AND ✓ Records of comparability studies reflecting performance at least twice per year with appropriate specimen types
| | If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments and methods are checked against each other at least twice a year for comparability of results. NOTE: This requirement applies to tests performed on the same or different instrument makes/models or by different methods, even if there are different reference intervals or levels of sensitivity. It includes primary and back up methods used for patient testing. The purpose of the requirement is to evaluate the relationship between test results using different methodologies, instruments, or testing sites. The laboratory must establish a written procedure for this check that includes acceptance criteria. The following types of materials may be used to generate data for comparability studies: ● Patient/client specimens (pooled or unpooled) are preferred to avoid potential matrix effects ●
Quality control materials for tests performed on the same instrument platform, with both control materials and reagents of the same manufacturer and lot number. ●
Alternative protocols based on quality control or reference materials for cases when availability or pre-analytical stability of patient/client specimens is a limiting factor. The materials must be validated (when applicable) to have the same response as fresh human specimens for the instruments and methods involved. This requirement only applies when the instruments/reagents are producing the same reportable result. . Evidence of Compliance: ✓ Written procedure for performing instrument and method comparison AND ✓ Records of comparability studies reflecting performance at least twice per year with appropriate specimen types
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Since we were also required to pull the CLEW update to every iSTAT every 6 months, and perform a thermal probe check after, we incorporated running liquid QC on every handheld at the same time as the CLEW since we already were having to get hands on each device at that time. That way we had data to use for comparing them all to each other. That counted as the iSTAT to iSTAT comparison. Typically we used CG8+ since we were using that in almost all departments. There is also tons and tons of EQC that could be used to compare all iSTATs to each other.
Separately, we compared the iSTAT METHOD to the core lab using a subset of handhelds twice a year for each analyte. For that we typically used freshly collected blood samples tested immediately on the iSTAT then transferred to a tube and tested in the lab. (Incidentally, old or stored blood samples don't work well for method comparison on the iSTAT).
Hope that helps!
Silka
Thanks,
John