In Oregon perhaps, but not in all states. On Oct 5, 2015 4:52 PM, "Kienitz, Kari" <kkien...@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 > kkien...@orclinic.com > > > > > CONFIDENTIALITY WARNING: This e-mail and any attachments are for the > exclusive and confidential use of the intended recipient. If you are not > the intended recipient, please do not read, distribute or take action in > reliance upon this missive. If you have received this in error, please > notify the sender immediately by reply e-mail and delete this message and > its attachments from your computer system. Thank you > ________________________________________ > From: Andy B via Histonet [histonet@lists.utsouthwestern.edu] > Sent: Monday, October 05, 2015 12:47 PM > To: histonet@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 <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