Calibration verification replicates

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Our hospital has both GEM 5000's and i-Stat analyzers that require semi-annual calibration verification.  The cal ver materials are SOOO expensive.  I'm wondering how many replicates others perform when doing cal vers on these analyzers.  Currently we do 2 replicates of PVP on our GEM's and 1 replicate of Tricontrol on our i-Stats.

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Sometimes we over-do out of habit or for security. I think you are doing enough. E.g Abbot does recommend running cal ver once for each level. Trouble shoot (include repeating) only if value obtained is not in range. Unless GEM states otherwise, I'd say once is OK -or 2 max like you are doing now. Basically there is no need to do 3 replicates of each level as I have seen some labs do for  calibration/verification of non-waived testing

Hi Angie, Methodist use i-STAT for blood gases and perform 1 replicate of the Cal/Ver for each meter that perform blood gases.

We do 3 replicates for each level, which is the absolute minimum necessary to calculate accuracy and precision of the system. 
  • I would also add that for systems like the iSTAT and Epoc, it is not necessary to complete Cal/Ver's on each analyzer, only the reagent LOT.  Smaller systems can do each analyzer but larger ones with potentially hundreds of meters this becomes unfeasible. 
    • It is required to do an initial Cal/Ver when placing a new meter into service. 

Looking at CAP's POC. 08300, it looks like we don't actually have to perform calibration verification ("Single use devices, and other test devices that do not allow user calibration, do not require calibration verification.").  So I guess we are really doing this as AMR verification.  In that case, does it matter if we are following the package insert instructions since we aren't actually using them to assess linearity?

From what I can tell, the i-Stat does not have specific guidance on the number of replicates, but the GEM PVP solution makes mention of running all 4 vials, 1 level at a time.  We also have other hospitals in our system that run RNA Medical CVC 223 on their Avox analyzers and its package insert states that you should run 3 replicates for each level.

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Angie Yost
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