CLIA 12/28/24 Technical Consultant interpretation

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.

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...

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. 

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

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

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. 

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

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.  

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

This has been an item we were planning to accommodate since the red flags were raised in 2024. Training is different than competency performance, so ensure your policies are lined up with that. It does not matter if you are COLA or CAP or JC, you must follow CLIA regulations. There are very clear outlines on who can perform competencies and what degrees will qualify for incoming Technical Consultants. All RNs that are listed as a technical consultant, and qualify by both the BSN and years of testing, are grandfathered in to remain on your list. You can even add test methods to them if they are on the roster (signed off by your medical director) by last December 28th. When those BSNs leave and need to be replaced, you will need to replace with qualified degrees. A BSN will only qualify IF they have had a certain number of specific science credits in their degree. There is a formula to use with it outlined for you. I reviewed our local university's BSN degree and it did not come close. 

We padded our team of BSNs prior to the Dec 28th date and are planning on moving forward in staffing with laboratory degrees that will qualify for our need that will eventually be present..when our pool of BSNs is diminished.

The organization that I work for was cited twice during a CAP inspection for not having a qualified person assess competencies for non-waived point of care testing. The first citation was for a MLT not having a four-year degree. The second citation was because the respiratory department supervisor who is a respiratory therapist signed off on the competencies. To prevent future citations, I was hired. I am the point of care coordinator with a 4-year Bachelor of Science degree in Biology and I have my hematology technologist certification from ASCP and a Master of Science in Healthcare Administration. I perform all the competency assessment for all of Cath Lab. I be in their control room observing... Electrophysiology lab, and open-heart surgery suite. I work with perfusionist and require them to meet with me prior to patient testing on the i-STAT to make sure they perform their competencies. Competencies are about 90% of my responsibilities.