CLIA effective 12/28/24 - testing personnel for glucose meters.

Hi Patsy, I can't see the attachment.  What does it say?

I also cannot open the attachment.

here is another image attachment in different format

I can't see/open the attachment, as others cannot, but Patsy "yes", the final rule has been out a while that states the effective date for Personnel changes is 12.28.24. However, what has been lacking is the interpretive guidance required (from CMS CLIA) on how the CLIA inspectors are to inspect. That info has not been released to CAP or TJC and no 'real' education has come out of CMS CLIA to date (the wording is "before it goes into effect" as far as educational information being released.
It would seem then that no company/industry could be issuing instructional info on Personnel yet, since CAP and TJC inspectors don't even know 'how to inspect' exactly and the updated CAP checklist has not been released...if you see where I am going with that.
We await your reveal on the NOVA information ;-).

Yes, Patsy, as the CLIA final rule is written, this would be accurate for any platform that has not been FDA-approved for use with critically ill patients. That's because using a testing method in a way it's not been approved for is "off label use" and automatically makes it a high-complexity test. According to the CLIA final rule, a nursing degree is no longer acceptable for personnel performing high-complexity testing. But before absolutely panicking, I'd wait and see what CAP and TJC come out with regarding it.

so it is still lab defines critical ill (with director approval) and as long as do not use meter beyond critical ill definition, really no issues
but if we use the meter for what is defined as critically ill then = high complex testing personnel and BSN do not quality as High complex TP. 

Yup, that's correct! It would always have been considered high-complexity testing, but the change in CLIA makes it so a BSN is no longer allowed to perform that high-complexity testing. So as long as you're testing within the manufacturer's instructions/FDA approval, you're good!

UMMM...on the Nova 'statement'...if one is using one of the devices under the 'cross out' in the picture in a clinically acceptable manner under a written policy which clearly identifies under which conditions to use and to NOT use the glucose meter the facility/institution uses, the approved for waived testing device can be used for waived testing glucoses.
The FDA approval of the device for waived testing is one thing; the (final rule) CMS Personnel 'rules' are a different matter.
PS the final rule already includes 'grandfathering' in some Personnel 'rules' 

Roche has stated that they have been approved for use in the critically ill, just no via a capillary collection. A few systems that I have spoken to have defined the term "critically ill" to be what is listed under the limitations of the glucometer that they are using. This allows them to continue to use a glucometer in any area. We looked at this option many years ago and wanted to manage it as pop-up for the physician to answer when the order would be placed for bedside glucose testing. The pop-up would then state those limitations and ask that the Dr. acknowledge m and sign off that the patient is eligible for glucose monitoring via fingerstick collection. Our system didn't go that route, but it is what made the most sense to the POCCs