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.
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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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.
Good Luck!