[Histonet] TC labs

Andy B certndx at gmail.com
Mon Oct 5 14:04:43 CDT 2015


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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