Validating New ABG analyzer

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Hi everyone,

I’m validating my first new instrument as a Respiratory Manager and have a few questions. I am performing 25 correlation studies between the current instrument, new instrument, and the back-up instrument which is an Istat. Does anyone have a validation plan for blood gases? Do you utilize the acceptable limits outlined by CLIA to determine whether the comparison studies are appropriate specifically for PO2?  Thanks for any help you can offer. 

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In addition to the correlation, you will need the following items:
  1.  2 levels of precision over "X" number of days (depending on your lab policy).  You can use external QCs.
  2.  AMR/linearity verification.  The manufacturer can provide this material.  Minimum of 3 levels.
  3.  Reference range verification.  

The acceptable limits need to be defined by your Lab Director and stated in your policy.  But yes, you can use CLIA/proficiency testing acceptable limits.

I also ordered a proficiency testing and had the staff run it.  It was past the due date and we were able to evaluate the results.  This always makes the Pathologist happy.  This was especially important for CoOximetry.
Good Luck!

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Frances Riley
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