AMR verification of hemoglobin derivatives

Hi Angie - in my experience, I think your interpretation would be incorrect.  If the operator's manual lists it as a measured test, then there should be appropriate AMR verifications performed for those tests.  I am not familiar with GEMs per se, but for other blood gas analyzers that list them as measured tests, that is the case.  And the test limits are clearly listed in the Cal Ver material provided by the vendor.

@James Beck - This was my thought as well.  I think the justification by others in my network is that they are covered by the hemoglobin since they are derived from it.  But really they are individual measurements and it's just the percentage that is derived.  Thanks for your reply!

Angie - I think we stand corrected - apparently GEM5000 are a different animal and per the vendor, they do NOT require external Cal Ver - see explanation below:

"The nice thing about the GEM Premier systems is that every time a GEM PAK is inserted, the analyzer automatically performs an Auto PAK Validation (APV). APV uses NIST‑traceable target values established during manufacturing for that specific PAK. This built‑in calibration verification (CVP) must pass for all analytes — including tHb and all tHb fractions — before the instrument will allow any patient testing. Because of this automated process, no external calibration/verification material is required, with one exception: tBili, which uses the external CVP5 ampoule.

 

Once the PAK is validated, iQM2 continuously evaluates system performance throughout the entire on‑board use‑life. It does this by analyzing five levels of Process Control Solutions (PCS A–E), monitoring both the stability of the PAK and ongoing calibration/accuracy and precision for each analyte.

 

We also offer a Performance Verification Product (PVP) with five levels that can be used for external linearity/AMR studies, if the facility chooses to perform them. PVP includes tHb, but not the hemoglobin fractions. Some customers order other vendor materials such as RNA Medical’s CVC to verify low range tHb and tHb fractions."

Hello again!  I actually still think we might be on the hook for AMR verification.  At my facility, calibration verification and AMR verification are separate evaluations (though they often use the same data).  For the cal ver we are looking for linear behavior, where with the AMR ver we are looking for the analyzer's ability to report values low and high enough to cover our established range.