[Histonet] EM as a "contract lab" lab for clia purposes

[Morken, Timothy]

Here's a question that came up. A stand-alone EM lab at a college that is associated with a medical center, but in a different city, wants to do the EM workup for the medical center. But they would only take in samples, do the EM processing and take images then the pathologist would read the images in the other city.

Does that lab need a CLIA certificate? Can they come under the existing hospital lab certificate (interpretation and signout is all done at the medical center in the other city) and be audited as contract lab?

My guess is they still need a certificate since they are handling human samples for diagnostics. But

Tim Morken
Supervisor, Electron Microscopy/Neuromuscular Special Studies
Department of Pathology
UC San Francisco Medical Center