New CLIA changes

Hi Deborah,
Look through this General Discussion thread from here....

Communication from NYS DOH RE: CLIA Rule Changes

I believe you'll find what you need.
Best

Hi Deb - seems 'everyone' including Accreditation folks are waiting for the Interpretive Guidelines for Laboratories (Survey Procedures & Interpretive Guidelines for Laboratories and Laboratory Services). 

The last message I heard related to final rule 'Personnel' changes that are effective the end of December 2024 is that information from CMS/CLIA will be coming out 'prior to the effective date'.

https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/guidelines-laboratories then scroll down to 'Downloads'. The 'current one' available is dated Feb 3, 2017. 

If I am reading the new rules correctly, nurses won't qualify for competency assessment.  I'm thinking they could, if we choose to, allow them to perform initial training as they do now.  But really initial training is documentation they know how to perform the test and are competent to proceed.  So not sure what everyone else is thinking in regards to the initial training.

I think the rule is stating that simply by having a BSN that nurses won't automatically qualify as a Technical Consultant, however, they could still qualify if they meet the educational requirements.  My last email to CLIA/DHSR they stated that they had not yet received any information on what the exact educational algorithm requirements are going to be for the Technical consultant when this new rule becomes effective

There is a POCT conference on October 3-4 (in Portland, Oregon) and a TJC surveyor will be presenting on this very topic. 2024 Northwest Point of Care Conference (eventleaf.com)

Thanks, Christin. Hopefully the TJC speaker is able to speak to the changes.
 
Congrats for all who worked on the NW POC Conference! I wish I could attend!
FYI I will give a shout out on someone I worked with at UTMB prior to his move to industry. He is on the CLSI POC Expert Panel and is a terrific asset for virology/micro documents. I'm happy to see he is presenting. Michael Michael Loeffelholz, Ph.D. D(ABMM), Vice President, Scientific Affairs, Cepheid

I worked 20 years as the Technical Consultant for a very large, multi-office, moderate complexity pediatric practice in NC.  In 2019, our CLIA inspectors informed us during an inspection that competencies had to be performed by a BS Lab Tech or The Lab Director/Manager.  BSN's, along with our lab techs, had always signed off on initial, 6 month and yearly comps.  We were told it was always the standard, but it was never pushed or citated, mainly due to the fact that not all office labs had lab techs, especially with BS degrees.  We were told eventually, CLIA would start citing deficiencies for this, but we were to start following the regulation since we were informed of it.  At that time in 2019, it was left up to individual inspectors on whether or not to push the regulation or not.  I haven't been in a physician office setting in 2 years, but my previous employees tell me this is still being thoroughly checked during inspections.  I understand the need for regulatory guidance on competency but know firsthand how big of a problem it creates for those who don't have the staffing/money to do them.  It will be interesting to see how this ends.

One thing the rules implied was that if you were a BSN and QE currently you could still continue after December so we are trying to get as many for POC approved by years end.  CLIA claims this update was in response to so many Lab professionals complaining about BSN.  Who are those people!  In POC world we rely heavily on nursing Education to assist with training and competency.  POC tests are essential tools for the nursing staff.  POC tests platforms are not the same a high complexity lab settings and I had hoped POC devices (at least the single use or multi-use cartridge designs) would be categorized differently.  This is going to really hurt our POC program.  We have a very small staff and a large number of devices and staff to check off.  CLIA is setting us up to fail. 

Can whoever attending the Northwest Point of Care Conference in October with the TJC speaker update this group on what was said? i think any information from a regulatory agency will help us all get through this. I agree with Ivy; we're getting as many of our current and possible nursing TCs on the list and designated by medical directors as we can before Dec 28th.

I'm currently doing the same thing as Ivy and building my pool of "currently qualified staff" to grandfather in. I have reached out to COLA and CAP with additional questions because all the webinars seem to be focusing on all the other changes like LTD. I have been told by both that they are "not finished reviewing and writing new guidelines". 
I understand and agree with the BSN and no highly complex testing but someone did not think this through for other applications. And how many people do you know who can produce a transcript for course review from 30 years ago??

Any news from that recent conference? I was not able to attend.

The NW POC conference is at the end of this week.

Any updates from the conference for those of us unable to attend? 
Honestly I think this rule was made without thinking of how it would impact point of care.

There was a lot of information shared. The 2 pieces that would affect POCT the most were the TC changes and PPMP changes. The surveyor sent a link that provided information regarding the Final Rule: Federal Register :: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories

TC changes that were presented: For RN's to qualify (or any non-lab tech) they have to meet the minimum requirements of science credits and have 20 hours of CE directly related to laboratory (over a lifetime). It was asked during the presentation if TC's would be grandfathered in. He was under the impression that no, they would not. However, one of the attendees researched that night and came back the next day to let all attendees know that she found that they WOULD be grandfathered in.

PPMP changes: only providers will be able to train AND perform Fern, KOH, etc. POCC TC's will no longer be able to train for Ferning. No other testing personnel allowed for Ferning.

I hope I captured that correctly. He also mentioned that we will not know anything until the day of and that the information has changed-even from 6 months ago.

I am still trying to find the TC and PPMP information in writing though. I do not see it listed in the Final Rule. Although maybe someone that attended was able to find more information?