[Histonet] TC labs

[Cert NDx]

I understand that to be the case as well. But in the case of TC only
laboratories where no full report is being rendered I have yet to see any
evidence that CLIA knocks on their doors.
On Oct 5, 2015 4:13 PM, "Debra Siena" <DSiena at statlab.com> wrote:

> If the lab performs gross examination in any way, the lab must be
> considered high complexity which puts the lab under the umbrella of CLIA
> and must be inspected every two years.
>
> Sent from my iPhone
>
> > On Oct 5, 2015, at 3:54 PM, Andy B via Histonet <
> histonet at lists.utsouthwestern.edu> wrote:
> >
> > Thank you. That is exactly what I would have given as an answer, but I
> have
> > yet to see any CLIA inspector or CLIA Operations manual that mentions any
> > of that, other than the vague statements about the Lab Director
> ultimately
> > being responsible. CLIA is not consistent with its rules and regulations
> > and interpretations. I would love for someone to prove me wrong!
> >
> > When is the last time someone actually witnessed CLIA verifying a TC lab
> > other than maybe being shown some QC logs, etc? I have yet to see any
> > Testing Personnel verifications from CLIA for TC labs. It is hypocritical
> > for CLIA not to inspect TC- only operations. If there is a standard form
> or
> > regulation for this, please show me. I have never seen or heard of a PC
> > only lab director being asked for verification of testing personnel
> > qualifications from a TC lab.
> >
> > Thanks in advance for everyone's input.
> >
> >> On Mon, Oct 5, 2015 at 3:42 PM, Andy B <certndx at gmail.com> wrote:
> >>
> >> Thank you. That is exactly what I would have given as an answer, but I
> >> have yet to see any CLIA inspector or CLIA Operations manual that
> mentions
> >> any of that, other than the vague statements about the Lab Director
> >> ultimately being responsible. CLIA is not consistent with its rules and
> >> regulations and interpretations. I would love for someone to prove me
> wrong!
> >>
> >> When is the last time someone actually witnessed CLIA verifying a TC lab
> >> other than maybe being shown some QC logs, etc? I have yet to see any
> >> Testing Personnel verifications from CLIA for TC labs. It is
> hypocritical
> >> for CLIA not to inspect TC- only operations. If there is a standard
> form or
> >> regulation for this, please show me. I have never seen or heard of a PC
> >> only lab director being asked for verification of testing personnel
> >> qualifications from a TC lab.
> >>
> >> Thanks in advance for everyone's input.
> >>
> >>
> >>
> >> On Mon, Oct 5, 2015 at 3:28 PM, Morken, Timothy <
> Timothy.Morken at ucsf.edu>
> >> wrote:
> >>
> >>> 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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