New CLIA 4% PT acceptable criteria for hemoglobin

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We use API for proficiency testing on our Avox 1000E in our cath labs.
We have hemoglobin unacceptable performance for the first two PT events this year. There were none last year.
Our QC and linearities pass. Pathlength is correct. Whole blood correlation to the core lab, Sysmex, is within acceptable limits.
I called API and they said they are seeing an increase in PT failures for hemoglobin with this new 4% criteria.
I am concerned that we will have failures on our 3rd event.
Is anyone else experiencing this?
Deborah Martuch
deborah.martuch@hf.org

8 Replies

JoAnn Crain

Wed Jun 18, 2025 at 10:04AM

Yes. The first CAP PT kit for the Avox had 3 unacceptable hGB's due to the new CLIA standard. I spoke with the Cardiac Cath team and they were not utilizing the result on the machine but using a lab based HGB for their equations. We stopped reporting it.
I also reached out to Werfen and opened a case.

JoAnn

Brian Wittkop

Wed Jun 18, 2025 at 10:05AM

Seeing the same thing here on our Avox 1000. Hopefully they get this changed for POC- these tight parameters shouldn't apply to POC testing. Either that or manufacturers are going to have to change.

Claudene Vidal

Wed Jun 18, 2025 at 10:25AM

We experienced the same for API during the first event, they did say the due to the new and tighter ranges there has been many failures. They recommended cleaning the optical filter before running proficiencies, resetting optical filter and making sure the pathlength on the cuvette and machine match. Our cath lab uses the hgb for calculation. I'm not sure if using it only for calculation=not reporting it, does anyone have an insight?

Brian Wittkop

Wed Jun 18, 2025 at 10:52AM

Appears API graded based on all peer groups for BLX-10 and not just the Avox peer group range. Based on just Avox peer group acceptable range, we passed. Not sure if that helps anyone else.

Attachment. — Screenshot 2025-06-18 095016.png

Niki Bradshaw

Tue Dec 02, 2025 at 10:11PM

As we have the ABL90 analyzers throughout our facility and only one AVOX in our Cath Lab, we aren't allowed to order the same API PT set for that single AVOX. How would you go about evaluating the AVOX to prove that the analyzer is performing correctly without having an available API set to test? I am concerned that the inspectors are going to ding us for this. I am brand new to being a POCC for a smaller level 2 hospital. Any guidance is appreciated.

Thank you,
Niki

Tara Slater

Wed Dec 03, 2025 at 6:54AM

Some one correct me if I'm wrong for Niki-
Your proficiency tests are for the analyte not the analyzer. So if your running PT on your ABL90 then anything else in your lab that runs that same analyte you do a method comparison between the two testing methods. This will prove to inspectors that the analyte is comparable to the one that you ran PT on.

Patricia Rauchholz, MT(ASCP), CPP

Wed Dec 03, 2025 at 7:26AM

We use PT material from WSLH, and our main blood gas instruments in the lab get the PT set for the GEM 5000's; I order the "QE" set, which is the same material, but to be run on a different analyzer (EPOC and AVOX), and submitted after the due date of the original set. I still do biannual method comparisons between my POC devices (Avox and EPOC) and the GEMs.

Danielle Ennis

Thu Dec 04, 2025 at 11:57AM

We use API for our blood gas and oximetry. We run the 'real' PT samples on our primary (most used) ABL90. We also order the Verification surveys from API for our other ABL90s and Avox, which are run after the 'real' PT deadline. It's the same samples, so we use those results as part of our method comparison too.

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New CLIA 4% PT acceptable criteria for hemoglobin