CLIA 12/28/24 Technical Consultant interpretation

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I am looking through the qualifications as of 12/28/24 in eCFR :: 42 CFR 493.1411 -- Standard; Technical consultant qualifications. We have RNs that perform competency assessments for moderate complexity POC tests currently. Looks like nursing degree is not sufficient now and we need to assess their transcripts for the required biology and chemistry coursework if they are not grandfathered in. Am I wrong? Nursing degree is denoted separately under testing personnel, so it seems clear that it is not enough for technical consultant now.

How are you interpreting this and how are you handling this going forward?

Thanks,
Danielle

11 Replies

Max Mauch

Thu Jan 30, 2025 at 2:06PM

COLA certified Laboratory. I called in to COLA for clarification on this, and they are stating that any RN degree does not qualify as a TC, even if the RN degree would pass the credit requirements for course work. This is putting us in a bind since our POC section is understaffed. Hopefully CAP would be more lenient.

Andrea Kelley

Thu Jan 30, 2025 at 2:09PM

That is correct. We have cap. Anyone currently a trainer can stay a trainer but they can not lapse being a trainer. Also you can look at their transcript and they must have 12 biology credits/12 chemistry credits and a total of 48 science credits to qualify

Ken Charpie

Thu Jan 30, 2025 at 2:18PM

Oh yes... : (
There has been a lot of discussion on here about the changes.

Not much we can do but make management and administration aware that our jobs are going to become more and more and more difficult with staff turnover. Each BSN I lose will make it harder until there are none left grandfathered in. Not sure how long that will take...

I keep having the conversation about this issue as often as I can with management and administration. It's hard for them to know how impossible our jobs are unless the wheels squeak some...

Danyel Olson

Thu Jan 30, 2025 at 2:22PM

Max - I have one COLA certified lab right now and used to have all 4 with them. COLA had a webinar in November addressing this and now I'm second guessing that they covered.

Training: There's really no regulatory requirements to be a trainer so an RN can still train if that is allowed per your own policy.

Competency assessment: RNs who were qualified previously prior to 12/28/24 were grandfathered in and can still qualify as a TC.
Maybe I'm incorrectly assuming that an RN could still qualify after 12/28/24 if you can confirm via the credit algorithm. COLA went through a couple examples in that webinar - I'd have to go back and listen again. There is an upcoming CAP webinar about this in February.

Ken Charpie

Thu Jan 30, 2025 at 2:24PM

@Danyel - Can you send the link for the upcoming CAP webinar?

Danyel Olson

Thu Jan 30, 2025 at 2:32PM

Focus on Compliance | College of American Pathologists See if this works

Otherwise I accessed this on the e-lab solutions page, Accreditation resources, focus on compliance, top of that page to register for the 2025 series

Liz Reed

Thu Jan 30, 2025 at 2:41PM

We are also in a bind with staffing issues and completing certifications/recertifications. I would like to know the logic behind this decision. It seems to me they keep putting impossible guidelines on us under the guise of patient care. I'm sure other medical disciplines are having their own compliance headaches. It's a wonder anyone is going into the med field.

Glen McDaniel

Thu Jan 30, 2025 at 2:43PM

The main issue is that an "RN degree" is not by itself a qualification, since nursing (e.g BSN) is not a science degree for the purposes of CLIA. I think some nirses could qualify by the degree and credit hours route (e.g RN with BS in biology), but you would have to go on a case by case basis. Also remember that current nurses will be grandfathered in if the continue in that role. For POCT we allow only waived testing. For ABG (moderate complexity) our respiratory therapists qualify

Ken Charpie

Thu Jan 30, 2025 at 3:11PM

Thank you, Danyel! I didn't realize those were there or had forgotten. Definitely going to attend.

I've probably got a dozen nurses delegated for moderate complexity competency assessment for more than 100 testing staff. I'm guessing in two years I will have less than half that number of delegated assessors, but closer to 200 staff performing testing. Completing direct patient observation is the most difficult part of competency assessment with non-lab staff. When the regulations prevent you from delegating help; they are basically ensuring non-compliance.

After discussing college transcripts with some nurses and hearing about the crosswalk, I very much doubt that I will find anyone with enough science credits to meet the new standard. Here's hoping, though.

Liz Reed

Thu Jan 30, 2025 at 3:21PM

Exactly...direct patient observation is where we have issues. When we're dealing with locations such as Cath Lab, the last thing they need in a busy, congested surgery suite is POC in the way 'assessing' their expertise. Also, the scheduling...some of this is trauma related personnel and we have about a 10 min window of notification. No one is going to think to call POC for a check off when they know a trauma is coming in. I'm not sure what we're going to do. It's not just for i-STAT either. Our perfusionists operate the Medtronic HMS and that is another that will be difficult to observe.

Danielle Keogh

Thu Jan 30, 2025 at 6:05PM

Thank you all for the feedback. And thank you Danyel for the webinar information!

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CLIA 12/28/24 Technical Consultant interpretation