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" <dsi...@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@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 <cert...@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.mor...@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@lists.utsouthwestern.edu] > >>> Sent: Monday, October 05, 2015 12:05 PM > >>> To: histonet@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? > >>> _______________________________________________ > >>> Histonet mailing list > >>> Histonet@lists.utsouthwestern.edu > >>> http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > _______________________________________________ > > Histonet mailing list > > Histonet@lists.utsouthwestern.edu > > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet