Proficiency and iStat
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I was recently told by a TJC surveyor that I did not have to perform proficiency surveys on our iStats. In the lab we use Seimens Dimension Vistas and the lab analyzers are considered the primary analyzer per the surveryor and the iStat is considered secondary. This is based off QSA.01.03.01 EP3: "The laboratory performs proficiency testing for each test method used as the primary method under each Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) certificate for each regulated analyte. Note: Proficiency testing for secondary analyzers is not required."
Has anyone else been told this? We have always completed proficiency on the iStat without being told this so I just want to investigate more before we make any changes.
Has anyone else been told this? We have always completed proficiency on the iStat without being told this so I just want to investigate more before we make any changes.
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To be honest, I would be uncomfortable not doing PT on my POC tests even if it isn't required. Why: I know for a fact that I can get perfect results on the iSTAT with the iSTAT QC and a floor user can't get it to pass. Why is this? Because of the difference in technique. I've seen this time and time again. Proficiency testing is explicitly stated that it must be performed by the users of the system. Is the lab staff doing the iSTAT to lab analyzer correlations? If true, this would miss a important component of PT testing. Doing PT testing is another quality metric to confirm the results going to the patients charts are accurate.
Thanks!
See below
ยง493.1281 Standard: Comparison of test results (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites.
If you qualify for verifying the accuracy of the testing in lieu of participating in proficiency, you would need to develop a plan (write a procedure/policy) on how the comparisons would be performed and how you determine if the comparison testing is accurate.