[Histonet] TC labs

[Cert NDx]

In Oregon perhaps, but not in all states.
On Oct 5, 2015 4:52 PM, "Kienitz, Kari" <kkienitz at orclinic.com> wrote:

> The State is responsible for inspecting/upholding a TC lab to CLIA
> regulations, every two years.
>
>
> Kari Kienitz HT, (ASCP)
> Histology Laboratory
> Gastroenterology-EAST
> The Oregon Clinic
> 1111 NE 99th Ave
> Portland, OR  97220
> 503.935.8311
> kkienitz at orclinic.com
>
>
>
>
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> ________________________________________
> From: Andy B via Histonet [histonet at lists.utsouthwestern.edu]
> Sent: Monday, October 05, 2015 12:47 PM
> To: histonet at lists.utsouthwestern.edu
> Subject: Re: [Histonet] TC labs
>
> 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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> >>
> >
> >
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