[Histonet] TC labs

[Debra Siena]

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. 

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> 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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