New CLIA requirements for Laboratory Technical Consultant and Non-Waived training/competency verification

Hi to all,
I actually sent an email to CMS describing the difficulty we will have in the future with the removal of the Nursing degree to qualify as a Technical Consultant. 
I encourage everyone to send them your stories on being  able to stay afloat with competencies for moderate complexity devices. They need to know how this will impact POCT departments.  I have a large program with my I stats and I am losing grandfathered TC's every month. 
Here are the emails of the regulatory lab staff at CMS:

Initial training doesn't actually have to be performed by a Technical Consultant.  Of course this is all relative to how you have your policies and designations set up. I encourage you to reach out to your accrediting agency to get clarification on this for your own records. 

But here is a copy of what I was given as a response by CAP about initial training:

Initial training can be performed by any personnel who are competent/ knowledgeable in all phases of the testing process. The laboratory may use the assistance of manufacturer’s technical support staff when installing a new instrument or implementing a new test; however, laboratory staff must be involved in the training process and laboratory-specific details must be accounted for.
 
As far as 6-month and annual competency checks, unfortunately this is just a struggle with the new regulations.  As of now our facility still has some RNs who are grandfathered in who were acting in these roles before the regulations changed...but as these employees either retire or leave our facility it will place more of these observations on myself to complete.

Hope this helps!

I have a nurse who qualified has TC and had served as educator for the cath lab staff for many years.  Unfortunately she had left us and gone to a sister hospital and was not working here on the Dec cut off date.  I called CMS and got a "No" when I asked since she was at a sister hospital would she qualify as TC here.  I encourage everyone to contact CMS.  This hospital is 130 beds.  I cannot imagine doing without qualified nurse educators in a big institution.   

We are revamping our whole system, essentially eliminating all nursing from the TC role.  We decided as a program that we could not plan for nurses to qualify as there was turnover, so our POCCs and RTs will take on all of it.  To accommodate, we're also implementing Telcor's eLearning interface to cut down on some of the manual user/recert activities, and moving toward scheduled sessions (like office hours) instead of the random access folks had to our POCCs before.  We've also changed how we document competency in our LMS to reduce paper/manual work.  We are delegating some lab MLS on night shifts to catch some of those semi-annuals that sneak up, as well.  We will go live with all of our changes in Jan 2026, so the actual impact of these changes to our POCC workload will be evident then.  I think it's entirely possible that we end up possibly needing to add a POCC FTE here or there.  Definitely some growing pains, but we're also leaning into the knowledge that consolidating this competency assessment effort to a smaller number of SMEs will ultimately improve the consistency of education that our testing personnel experience.  Good luck, everyone!

Since the new regs started this year, we have started training staff to be Super I stat trainers . We always used our TC's to do this in the past. 
These Super I stat trainers come through the POCT office and have a checklist. Once that is completed, at least they can train on their floors. 
That helps take some burden off my staff. 
Please POCT coordinators, let the CMS know how this ruling impacts POCT moderate complexity comptencies. 
Probably in these times of hospital reduced money from the medicare/medicaid system, I will not get any extra POCT  staff for the future. 

We are praying our current nurses that were grandfathered never leave. lol we are still working on ways to handle this.  One idea is a newly retired mls hire in as contingent. Or we have talked to leadership about adding in a fte.  We did add nurse trainers in the fall last year to increase the nurses that are tc so hopefully push it down the road for awhile. 

We are praying our current nurses that were grandfathered never leave. lol we are still working on ways to handle this.  One idea is a newly retired mls hire in as contingent. Or we have talked to leadership about adding in a fte.  We did add nurse trainers in the fall last year to increase the nurses that are tc so hopefully push it down the road for awhile. 

Yep...this CLIA decision is making retirement look tempting...

I have a 7-hospital system that has a POC "representative" in each hospital. I also have BS RT for ISTAT comps in RT. 

This POCT "representative" is a BS MT that can perform demonstration comps-usually a lead bench tech that has been assigned the POC duties. (CLEW update etc.)  The instrument demo is usually the ISTAT or the AVOX. 

The laboratory POCC can do the comp when the operator comes to lab by appointment. This will be about the only way that I will have to complete these demo comps in the individual hospitals once my "grandfathered" RN are all gone. I use the lab "POCC" when there are PRN operators who cover call in the Cath Lab, or someone coming off nights that can see the POC post morning run, for instance. 

For the most part, there is a lot of driving on my part to obtain these comps. 
It has been this way for the 14+ years I have been doing this job. In the beginning, it was a about 300 miles a month on my car.  I would start in January and be done by November. (about 700 operators) 

 As I have gotten better at the organization of the comps (setting months that comps are targeted) and gained acceptance by the nursing units that cooperation is beneficial for them for patient care, the driving is still significant, but only in certain months. 

We are also setting thresholds for the usage of POCT and have a very strict process as for when new POCT testing will be granted to a unit-especially with the ISTAT. We are looking at ISTAT volumes in the 4 ER areas that have ISTAT now as a project-who is trained, the volumes they are using etc. 

We are under one CLIA...the one that belongs to the main lab. It should follow that (eventually) the main lab will need to assist POCT, especially in large POCT programs. 

I'm still trying to wrap my head around these changes. Does anyone have the link to the rule change so I can discuss with my Clia director. 

That’s a great idea, starting outreach to CMS is a proactive step, especially given the significant impact this will have on many of us in the near future. Raising awareness now could help flag the challenges we’re already facing.

I’ve been increasingly concerned about this issue myself. I’ve already lost several RN TCs this year, and in some departments, there is only one TC to begin with. Once they’re gone, the responsibility falls entirely on me, which isn’t sustainable long-term.

Hi Christin,
I agree that we need to make some noise to CMS as they have no clue how this affects our departments going forward. We just lost our TC for the Cardiac Cath lab so that is falling on my team and there will be more in the future. We have over 1,500 operators for mod complexity. We also get more requests every month for more POCT. It is mind boggling on how POCT departments  can support that many competencies and still maintain ourselves at a high regulatory level.
I tried to raise the red flag last fall to recruit extra TC's last fall  when I heard this was going to happen but no one wanted to listen. 

We have around 450 operators for non-waived POC testing.  We were already doing competencies on about half of those and we will need to come up with a plan for the rest.  Interestingly enough, I just learned that even though RT's are listed to be able to sign off on blood gases, it is only for specific blood gas analytes: pH, pCO2, pO2, etc.  They are not qualified to sign off on Na, K, Glucose, etc.  I heard that on a webinar so I called CAP to verify if that is correct.  This is NOT listed in the regulation clearly, so we are upset with the vagueness! Honestly, it doesn't clearly state in the regs that nursing degrees don't count anymore, unless I am looking in the wrong place.  I feel like these regs are not truly black and white and do leave some openness for interpretation.  They need to be better about that if that's what they want!  Anyway, I digress.   We have found it helpful to get locations scheduled in a certain month of the year for completing their competency.  We also have multiple POC Coordinators that can do the competencies to help with scheduling.  For our Hemochron INR, we have them complete the troubleshooting portion by doing a quiz in our education software (Workday) and then they meet with us to complete the rest.  That has saved some time.  We are in the beginning stages for the Telcor/eLearning system, but that really only helps us with waived testing, not non-waived.

Hi Miranda,
The regs don't say directly that the nursing degree does not qualify but if you are not a lab, chem or bio major , a nursing degree does not have enough science credits to quality to be  a TC. I have even looked at nursing with advanced degrees and most of their classes are deemed NURSING classes.  Nursing degrees do not qualify as a Bachelor's degree equivalency unless they had another science major such as BIO or CHEM. 
Here is the exact wording from the CAP Personnel Guidance Document which follows CLIA regulations:

Can anyone help clarify - what were the regulations to be "grandfathered" as a nurse TC?