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
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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