Is your POC or glucometer under a different CLIA# than the main lab in the hospital setting?

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I noticed from the discussion "POC Glucose questions regarding PCTs/CNAs" some hospitals have a separate CLIA certificate for their POC or Glucometers? We have it under the main lab CLIA #, what is the reason for it to be separate?

4 Replies

Shonda Stamps

Wed Mar 10, 2021 at 12:31PM

POC is under the same CLIA# as the main lab in our hospital. There are a few locations that perform waived POC testing offsite that I monitor (NOVA, iSTAT) and they have their own CLIA license. However, our future plan is to not monitor those sites

Jeremy MacDonald

Wed Mar 10, 2021 at 1:27PM

Separate CLIA certificates for the Lab and POC
Pros:

If your POC program is "challenged" and there is significant risk of citations the benefit is that it these citations will not affect the main lab. Example: if regulatory says you can't do qualitative HCG testing anymore because you keep getting cited on it in POC you can still do it in the lab under the lab licensure.

Cons:

It will cost more in licensure.
It will require significantly more work and documentation in the form of supporting policies, for example you can not point to the lab QA program and say it covers POC too you would need two separate policies and two QA programs. You would effectively need two separate systems and supporting documents.

Michelle Wilcox

Wed Mar 10, 2021 at 2:09PM

We have kept our nursing, emergency room and clinic CLIA certificates separate from the laboratory because we did not want them under CAP. And to be honest, they didn't want to deal with CAP either. With their own certificates they have to own some of the responsibility of maintaining their POC program. I am the POCC for our hospital group, but they know if they do not follow guidelines, it is their "butts" on the line, not mine, not the lab's.

Pet Maniquis

Thu Mar 11, 2021 at 8:59AM

Our reasoning for having 2 CLIA certificate is the same as Jeremy's. WE do not want to jeopardize the Lab CLIA certificate if nursing staff made a big "error" if they are under the lab CLIA. We used to have Non-waived tests inspected under CAP; waived tests under TJC. The hospital pays for the Waived CLIA certificate. Lab pays for the non-waived. But now both are inspected by TJC. We still keep separate CLIA for Waived and Non-waived tests.

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Is your POC or glucometer under a different CLIA# than the main lab in the hospital setting?