CLIA Waiver.... Do you have one?

[k1p1ssk, BSN, RN]

According to the FDA/CDC/CMS (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf), if we perform routine Blood Glucose Testing, Urine Ketone checks, have students with prescribed CGMs, or other, minimally risky lab procedures, our schools/districts need a CLIA waiver. There was an emergency Federal CLIA waiver for all schools during the era of in-school COVID testing programs, but that ended the Summer of 2022 or 2023, I believe. 

With that said, how many of you have CLIA waivers? Before COVID, I don't think I knew any schools that had them. Writing this as I'm realizing ours expires in February and I don't have any more money in the budget to cover the fees!! 

[arlingtonnurse]

Woops... never heard of this one.  Certainly don't have it... guess I'll bump this on to my manager 🙂

[k1p1ssk, BSN, RN]

arlingtonnurse said:

Woops... never heard of this one.  Certainly don't have it... guess I'll bump this on to my manager 🙂

Yeah, I think it was something we had just shrugged about - it had never been mentioned in any meeting before COVID and then all of a sudden the state reps were like, "FYI, once this emergency authorization ends, you'll have to get your own again" and there was a collective "Again?"

I'm still unclear if you need one if the nurse isn't performing the task - say an independent T1DM student needs to do a fingerstick or is checking ketones and is just doing it themselves - the nurse isn't performing it and is also not interpreting the results, so I'm not sure how necessary it is if that is all you do in your district... either way, I'm going to wait until the new fiscal year to apply again. 

[SandIsMyGlitterRN, BSN, RN]

We have always had a CLIA here.  We had to add to it for COVID testing when that happened but we are back to our regular one now. 

[nurse__ab19]

Had never heard of this until now. I emailed our state department of health and from what they explained, any testing (fingerstick, urine ketones) that the nurse "interprets" the results and makes a clinical decision based off of I.e. treating a low sugar, you are to have this "Certificate of Waiver". This also includes if you are monitoring a kid via a Dexcom monitor. 

 

[k1p1ssk, BSN, RN]

nurse__ab19 said:

Had never heard of this until now. I emailed our state department of health and from what they explained, any testing (fingerstick, urine ketones) that the nurse "interprets" the results and makes a clinical decision based off of I.e. treating a low sugar, you are to have this "Certificate of Waiver". This also includes if you are monitoring a kid via a Dexcom monitor. 

 

Yes, exactly. The application and fee is $180 and the waiver is good for 3 years...