Have y'all seen this? It looks like our waived EUA devices won't be able to test asymptomatic patients unless it's allowed in the IFU. Not sure how this will affect our operations at this point, but I wish they had saved this for a later time!

How does your program perform direct patient observation for moderate complexity testing in POC?
(I would  especially love to hear examples for blood gas, amniotest and ACT testing. These have large user bases and smaller test volumes, which makes this task especially difficult)

If you use non-lab staff as competency assessors, are you confident that they are actually observing patient testing that could be pulled ...

We are maintaining a Piccolo here at Henry Ford Hospital (Detroit) as part of our Ebola program and we struggle year after year to achieve decent results when comparing the Liver Panel Plus to the instrument in the main lab (Beckman-Coulter AU). 

Is anyone experiencing the same issues? If so, how is this being addressed (i.e. bias calculation, qualifying statements, etc.).

Thanks for any information!