[Histonet] TC labs

Morken, Timothy Timothy.Morken at ucsf.edu
Mon Oct 5 14:28:34 CDT 2015

What I believe happens is that the referring lab must do an audit/inspection of the technical-only lab to be sure they are CLIA compliant. For instance, check validation procedures for stains, equipment, quality control. It's true CLIA itself does not inspect the Tech-only lab, but the referring lab becomes the "technical supervisor" and must have documentation to show they have inspected it and it is compliant. That is how it works for vendors using other labs to do work for them under FDA regulations.

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

-----Original Message-----
From: Andy B via Histonet [mailto:histonet at lists.utsouthwestern.edu] 
Sent: Monday, October 05, 2015 12:05 PM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] TC labs

Does CLIA inspect labs that only perform Technical Components on tissue?

I know that CAP does so as part of its due diligence, however years ago a CLIA inspector told me that CLIA doesnt inspect TC-only operations because there is no report (PC) being rendered. How does this jive with grossing and the new High Complexity Testing (HCT) paradigm?

In other words, what is to prevent a pathologist (or non-pathologist) from owning and operating a TC lab service that is remote from the PC service location? How does CMS verify that TC labs are correctly and compliantly performing grossing (HCT) and other TC lab evolutions if they do not inspect such operations?

I know of labs that are TC only and bill CMS for the Technical Components.
Has anyone else ever wondered about this? How is CMS assuring that TC labs are compliantly staffed and managed if CMS only inspects labs that issue reports?

Does anyone wonder how CMS can get away with hammering some labs and ignoring others?
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