POC.08600 lot change ABL90 and i-STAT
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In the most up to date requirement for AMR verification (POC.08600) it states that the AMR must be verified at changes or reagent lots "unless the laboratory can demosnstrate that use of different lots does not" effect the accuracy of results/range.
How are people meeting this requirement for ABL 90 and/or I-STAT?
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For the ABL90, we run 3 levels of QC to verify lot change. It is impossible to do lot-to-lot parallel testing. We also have a letter from Radiometer stating below:
"Base on our discussions with CAP and Joint Commission, the onboard QC material is considered the same as external QC. Due to this status, the ABL90's internal QC may also be used to verify new lots of solution packs and sensor cassettes..."
For the ABL90s, we run 3 levels of ampoule QC when we change the solution pack. The ampoule QC covers a broader range than the built-in QC
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