Non-waived Proficiency testing Joint Commission Requirements

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Hello,
I recently had a Joint Commission Inspector tell me that our hospital didn't have to perform Non-waived Proficiency testing on analytes that aren't considered "Primary". I am considering this because it will save me time and the hospital money. What are your thoughts on this?

6 Replies

Kathleen David

Thu Mar 27, 2025 at 2:55PM

We don't do PT on devices when the lab has the primary instrument--blood gas, metabolites, glucose, etc. We do alternative proficiency on those tests. This is only if the lab and POCT are under the same CLIA. We are already doing comparisons of POCT to the lab every 6 months.

Melisa Wagoner

Thu Mar 27, 2025 at 3:03PM

Yes, this is true.
You also don't have to do PT on non-regulated analytes. You will have to follow QSA.01.05.01 to semiannually evaluate accuracy and reliability of those results.
We chose to no longer do PT on ACT testing as the PT samples were packaged the same as Hemochron QC causing us to fail some surveys due to operator technique errors. It also happened to be a non-regulated assay. Each survey was nerve racking and were glad to part ways with PT for that test!

Kayla Cooper

Thu Mar 27, 2025 at 3:14PM

@Melisa Wagoner - what do you mean by "not regulated" for ACT's?

We do not do PT's on analytes where we are not the gold standard/primary method. The primary method performs the PT's and then we do method comparisons every 6 months. I just called CAP about this last week because I wanted to put documentation in our binders. They confirmed that this is acceptable.

Melisa Wagoner

Thu Mar 27, 2025 at 3:26PM

CLIA regulated assays- ACT isn't one of them and was confirmed by JC. (You're going to have to do a deep dive in CLIA regulations, I can't recall the exact location of the listed assays).This is just pertaining to PT participation. 6 month comparisons are still required for this as it's a moderate complexity test. But it's not mandatory to perform PT for this.
We are JC inspected and not CAP so I can't speak to what CAP requires.

Michelle Cheslock

Thu Mar 27, 2025 at 3:36PM

From what I understand (according to CAP), the "Alternative Proficiency" methods like patient comparison still need to be performed by the people who are normally running that POC test. So you'd save on having to purchase PT material, but the process would still be similar, in that you still need your POC operators to run the samples.

(If I am wrong about this, I would be STOKED to hear it)

Reine Makiya

Thu Mar 27, 2025 at 4:47PM

We switched to the AQQ, AQSQ, SOQ events because the main lab was the primary and we did not want any POCT failures to jepardize our CLIA certification. We didn't feel that we could not do any kind of PT at all. We treat the Q surveys the same as regular PT, run by the POCT operators not POCC. We still do ACT (CAP CT-1 for the HMS+ and CAP CT-2 for the Hemochron Sig Elites) because lab does not run that test, even though it's not a regulated analyte.

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Non-waived Proficiency testing Joint Commission Requirements