[Histonet] TC labs

[Andy B via Histonet]

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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Re: [Histonet] TC labs

[Morken, Timothy via Histonet]

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?
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Re: [Histonet] TC labs

[Debra Siena via Histonet]

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 
> 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" 
> 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 
> > 
> 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 
>> > 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 
>> >
>> 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?
>>> 

Re: [Histonet] TC labs

[Andy B via Histonet]

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  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 
> 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
>>
>
>
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[Histonet] (no subject)

[Merrill, Dawn S via Histonet]

Can you please unsubscribe me to this mailing list.
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[Histonet] (no subject)

[Angela Davis via Histonet]

Pls unsubscribe me
Thank you!
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Re: [Histonet] TC labs

[Debra Siena via Histonet]

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 
>  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  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 
>> 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

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[Histonet] Unsubscribe

[Lora Jauregui via Histonet]

Please unsubscribe me from this list.

Thank you


Lora Jauregui

Lab Manager

Diagnostic Pathology Associates

409-842-8222

l...@dpallp.net
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Re: [Histonet] TC labs

[Kienitz, Kari via Histonet]

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  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 
> 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
>>
>
>

Re: [Histonet] TC labs

[Cert NDx via Histonet]

In Oregon perhaps, but not in all states.
On Oct 5, 2015 4:52 PM, "Kienitz, Kari"  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  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  >
> > 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 

[Histonet] Small cell lung blocks

[Clarence Owens via Histonet]

Hello all,

Does anyone have any small cell lung blocks they can spare for control tissue. 
I'm working on a new lung antibody and could use some control material. Thanks 
in advance for your help. 

Regards

Clarence 

Sent from my iPhone
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Re: [Histonet] TC labs

[Cert NDx via Histonet]

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"  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  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] FW: GMS and Gram stains

[Morken, Timothy via Histonet]

From: Histology [hi...@pathlab.us]
Sent: Monday, October 05, 2015 5:18 AM
To: Morken, Timothy
Subject: RE: GMS and Gram stains

1.  Gram:  Sigma-Aldrich Accustain
2.  Gram:  Hard to see gram negative

1. GMS:  Grocott's Methenmmine Silver modified
2. GMS:  Switched from microwave to oven.  Too long (2 hours) and can't seem to 
get the fungi dark enough.

Thanks

-Original Message-
From: Morken, Timothy [mailto:timothy.mor...@ucsf.edu]
Sent: Friday, October 02, 2015 12:16 PM
To: Histology
Subject: RE: GMS and Gram stains

Mehndi,
These procedures are so common that without more information you are likely to 
get a lot of people sending you procedures that are identical to what you now 
use.

The questions we will ask are:
1) what procedures are using now?
 and
2) what is it about your current procedures  that is not acceptable?



Tim Morken
Pathology Site Manager, Parnassus
Supervisor, Electron Microscopy/Neuromuscular Special Studies
Department of Pathology
UC San Francisco Medical Center



-Original Message-
From: Histology via Histonet [mailto:histonet@lists.utsouthwestern.edu]
Sent: Friday, October 02, 2015 4:59 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] GMS and Gram stains

Hi All Netters,

I need to get a better GMS and Gram stain.  If anyone could share their 
protocols where they get the solutions that would be fantastic.

Thanks,

Mehndi Helgren

Dominion Pathology Labs
Norfolk, VA (AKA Hurricane Central)  :)


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[Histonet] FW: billing consults

[Horn, Hazel V via Histonet]

_Please respond privately if you would rather.  If you have billed for the 
professional component, do you bill the patient again for the consultation if 
you have sent it out 
to a pathologist for confirmation or diagnosis?
__

From: Horn, Hazel V via Histonet [mailto:histonet@lists.utsouthwestern.edu] 
Sent: Thursday, October 01, 2015 12:52 PM
To: histonet (histonet@lists.utsouthwestern.edu)
Subject: [Histonet] billing consults

Histonetters,


 1.  Please see the questions about billing for Pathology Consultations under 
varied circumstances as denoted below. For each circumstance, please specify 
whether you bill,
a) professional and technical only, or
b) professional, technical and consult.


 1.  If your response choice is b), please specify whether your payors 
typically pay for the consult charge.
==


 1.  The pathologist to whom the case was assigned has some doubts as to the 
best diagnosis after all attempts to classify the lesion.
 2.  The department has some disagreement about the diagnosis and sends the 
case to another pathologist to help decide the matter.
 3.  The clinician and/or patient requests a second opinion from another 
pathologist.



Hazel Horn
Supervisor of Histology/Autopsy/Transcription Anatomic Pathology Arkansas 
Children's Hospital
1 Children's Way | Slot 820| Little Rock, AR 72202
501.364.4240 direct | 501.364.1241 fax
hor...@archildrens.org
archildrens.org







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Re: [Histonet] Missing specimen

[Pratt, Caroline via Histonet]

I agree with using caution, but these are not truly comparable as a Pathologist 
can tell the difference between a child's skin and the skin of a mature adult 
under the microscope.


From: Aimee Tolentino via Histonet [histonet@lists.utsouthwestern.edu]
Sent: Friday, October 02, 2015 6:15 PM
To: Kim Donadio
Cc: Frazier, John; histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] Missing specimen

I've had something like this occur before. Unfortunately things did not end 
well. The prostate needle biopsies were labeled for two separate patients were 
labeled the same accession number and patients name. After playing the guessing 
game and sent those results out without a DNA they had removed a perfectly 
healthy prostate from the patient who did not have prostate cancer while the 
other had not received treatment. We later found this out through DNA after the 
healthy patient had gone through surgery for them to realize he didn't have 
cancer. So you MUST do the DNA.

Sent from my iPhone

> On Oct 2, 2015, at 1:00 PM, Kim Donadio via Histonet 
>  wrote:
>
> Stand your ground. Youre right! Patients lives are not guessing games. I 
> wish you the best and must forewarn you. Choosing integrity in this day and 
> age is a lonely road and often doesnt pay well. But your conscious will 
> be clear and its the right thing to do.
> ___
> Histonet mailing list
> Histonet@lists.utsouthwestern.edu
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet

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