[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
Re: [Histonet] TC labs
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
Re: [Histonet] TC labs
They do on my lab which is TC only. Debbie Siena Sent from my iPhone On Oct 5, 2015, at 4:34 PM, Cert NDx <cert...@gmail.com<mailto:cert...@gmail.com>> wrote: 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<mailto: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<mailto: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<mailto: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<mailto: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<mailto:histonet@lists.utsouthwestern.edu>] >>> Sent: Monday, October 05, 2015 12:05 PM >>> To: >>> histonet@lists.utsouthwestern.edu<mailto: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) &
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
Re: [Histonet] TC labs
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
Re: [Histonet] TC labs
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 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
Re: [Histonet] TC labs
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 > 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
Re: [Histonet] TC labs
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) > >>&g
