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

Paula Keene Pierce paula at excaliburpathology.com
Mon Mar 30 18:30:49 CDT 2020

Yes, they would still need the certification, however as only the technical part. A pathologist will need to be designated the medical director and all pathologists reading the results will need to have their credentials added.
The medical director will need to also sign off on any complex procedures, ie. gross examination, done by the lab personnel.
Paula Keene Pierce, BS, HTL(ASCP)HTPresidentExcalibur Pathology, Inc.5830 N Blue Lake DriveNorman, OK 73069PH 405-759-3953http://www.excaliburpathology.com

A sharp knife is nothing without a sharp eye. - Klingon Proverb 

    On Monday, March 30, 2020, 05:43:58 PM CDT, Morken, Timothy via Histonet <histonet at lists.utsouthwestern.edu> wrote:  
 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

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