CMS communication for waived Covid testing devices

THANK YOU
And Oh Dear!

No, but thank you!!  I had to go look at my IFU again lol.  Thank goodness it doesn't specify symptoms.

This is most certainly going to require some conversation.

I  cannot find this CMS memo online.  Where did you get this?  Game changer for some instruments.

QSO-22-25-CLIA (1).pdf

Here's the document from CMS

This looks like it includes all molecular and antigen testing for Covid on asymptomatic patients, waived or non-waived.  Am I reading that correctly?  If so this could pose an issue for our entire lab, not just POC

If they are in existence because of an Emergensy Use Authorization- you are correct.  All labs will be affected, unless the test has been put in place as laboratory developed. 

Basically, it's saying that we need to follow the manufacturer's instructions for use, including patient type, for our waived devices at POCT. For the lab, if the test is being used outside of IFU, then it would be high complexity, so could only be run in a high complexity lab that has done a complete validation, including validating asymptomatic patients. For our sites, we're good with the labs as we did a validation and they are mostly high complexity labs (doing transfusion medicine). For POCT, we do have devices at sites doing pre-procedure, pre-op testing, so we'll need to stop that. As Rosann Rosannadanna says "It's always something". 

Kathy 
Thank you so much for relaying this information to the group!  The directive states we have 30 days from issuance to come into compliance.
Our incident command convened today to discuss the ramifications:

Updated algorithms would be very helpful as we have a limited window to make these changes.

Stephen,

Looks like there are two on this list:
At-Home OTC COVID-19 Diagnostic Tests | FDA

Today's latest!! What is happening??

Someone sent this to me as well. We think it's related to rescinding the earlier document that allowed testing asymptomatic patients, meaning outside of the IFU. I'm not going to do anything on this until any further information.