Re: [Histonet] Her2 Reflex

[Terri Braud via Histonet]

Re: Her2 by IHC
We reflex 1+ to FISH, too

Terri L. Braud, HT(ASCP)
Anatomic Pathology Supervisor
Laboratory
Holy Redeemer Hospital
1648 Huntingdon Pike
Meadowbrook, PA 19046
ph: 215-938-3689
fax: 215-938-3874




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Re: [Histonet] Her2 IHC

[Mark Tarango via Histonet]

My lab does not have a written policy on this yet but are discussing it.
If the patient has a high grade tumor and HER2 IHC is 1+ (or even 0+), some
of our pathologists will reflex to FISH.  The oncologists will request it
sometimes too, more often when ER and PR are both negative.  We have found
several cases to be positive by FISH that were 0+ or 1+ by IHC.  I can't
say anything about response to HER2 therapy in this group of patients just
that they met the criteria for positive by FISH.

Mark T.
Cellnetix
Seattle, Wa

On Thu, Nov 3, 2016 at 9:12 AM, Algeo, Lacie A via Histonet <
histonet@lists.utsouthwestern.edu> wrote:

> Are any labs reflexing 1+ for FISH?
> Thanks :)
> Lacie
>
> Lacie Algeo, HTL (ASCP) MBCM
> Histology Supervisor
> Providence Sacred Heart Medical Center Laboratory
> 101 W 8th Avenue
> L-2
> Spokane, WA 99204
> 509-474-4418
> FAX 509-474-2052
> lacie.al...@providence.org
>
>
> This message is intended for the sole use of the addressee, and may
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RE: [Histonet] Her2:

[Morken, Timothy]

Craig, 

CLIA licensure gives your lab the authority to validate and use ASR's for 
diagnostics. For something like her2 you will need to compare it to an existing 
FDA approved antibody, run the statistically significant number of cases (range 
of positive, and negatives) and show high correlation between them. If you want 
to use an FDA approved antibody on a different platform you still need to do 
the validation and compare the results between the platforms. Vendors typically 
run many hundreds of cases for their FDA approval but most labs run 50 to 100. 
But with smaller numbers of cases it can be hard to get the high correlation 
you need (95%+). Your pathologists need to develop a validation plan and decide 
if it is suitable.


Look at this site and go the link at the bottom for Subpart K, Part 1:  
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html


Look for section 493.1253(B)(2). Below is the intro. The standard is many pages 
long and tells you what you need to do to use FDA kit on a different platform 
than the manufacturer used for FDA certification. It is a full validation. 

This same standard applies to ASR's

§493.1253 Standard: Establishment and verification of performance 
specifications.
(b)(2) Establishment of performance specifications. Each laboratory that 
modifies an FDA-cleared
or approved test system, or introduces a test system not subject to FDA 
clearance
or approval (including methods developed in-house and standardized methods such 
as
text book procedures, or uses a test system in which performance specifications 
are not
provided by the manufacturer must, before reporting patient test results, 
establish for
each test system the performance specifications for the following performance
characteristics, as applicable:




Tim Morken
Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
UC San Francisco Medical Center
San Francisco, CA

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-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Jb
Sent: Tuesday, January 27, 2015 10:50 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Her2:

Can anyone give me suggestions of what they are using for Her2?  What are your 
thoughts on FDA cleared kits vs ASR?  Good products/cost efficientgeneral 
thoughts. 

Also, does anyone know or have any literature stating that an FDA cleared kit 
has to be used on a specific platform that it is specified for? 

I have heard that an FDA cleared test has to be used on the company's specific 
platform to maintain the FDA status.  Does anyone have info/literature 
supporting this?

Thank you,

Craig

Sent from my iPhone
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RE: [Histonet] Her2 IHC validation

[Joelle Weaver]

Yes, check the ASCO/CAP guidelines there are correlation rates for positives 
and negatives. 


Joelle Weaver MAOM, HTL (ASCP) QIHC


  

 
From: mw...@wakehealth.edu
To: histonet@lists.utsouthwestern.edu
Date: Thu, 22 Jan 2015 20:21:53 +
Subject: [Histonet] Her2 IHC validation

In advance of preparing for our CAP inspection window, I am working on our 
validation write-up for our Her2 IHC and was looking for some data concerning 
the correlation rates.We compared our IHC staining to FISH Her2 results on 
the same case.  Is there a minimum correlation rate?   I have been unable to 
find one in my reading.   Thank you in advance for your help.
 
 
 
Martha Ward, MT (ASCP) QIHC
Manager
 
Molecular Diagnostics Lab
Medical Center Boulevard  \  Winston-Salem, NC 27157
p 336.716.2109  \  f 336.716.5890  
mw...@wakehealth.edu  
 
 
 
 

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RE: [Histonet] HER2 by IHC- Fixation

[Weems, Joyce K.]

That is true.

Joyce Weems
Pathology Manager
678-843-7376 Phone
678-843-7831 Fax
joyce.we...@emoryhealthcare.org



www.saintjosephsatlanta.org
5665 Peachtree Dunwoody Road
Atlanta, GA 30342

This e-mail, including any attachments is the property of Saint Joseph's 
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intended recipient, please delete this message, and reply to the sender 
regarding the error in a separate email.

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Adesupo, 
Adesuyi (Banjo)
Sent: Wednesday, June 04, 2014 12:21 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] HER2 by IHC- Fixation


 Hi Histonetters,
 I hope you guys are doing great. Please I wanted to 
confirm whether it is true that the CAP has changed the HER2 Fixation time from 
6 - 48 hours to 6 - 72 hours.


  Thanks,

  Banjo Adesuyi, BSMT, HT (ASCP) HTL, QIHC, QLS
  Histology Supervisor
  Norman Regional Health System,
  Norman, OK 73071.
  Tel: 405- 307- 1145

==
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RE: [Histonet] HER2

[Britton, Josette C]

We use Integrated Oncology-Lab Corp, 521 West 57th Street, 6th floor,
New York, NY 10019 800-447-5816

Josie Britton HT (ASCP) QIHC
Cheshire Medical Center
580 Court Street
Keene, NH 03431

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of joelle
weaver
Sent: Tuesday, May 13, 2014 6:12 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] HER2

Hi Histonetters
I am looking to compile a list of potential sites do send out Her2
slides for correlation on a validated assay. I have the Bond, using
Refine detection. My clone is the Cb11, Oracle.
Thanks in advance for any information you can provide.




Joelle Weaver MAOM, HTL (ASCP) QIHC

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RE: [Histonet] HER2

[joelle weaver]

Thank you Josie this is very helpful. 




Joelle Weaver MAOM, HTL (ASCP) QIHC
 
 Subject: RE: [Histonet] HER2
 Date: Wed, 14 May 2014 07:22:39 -0400
 From: jcbrit...@cheshire-med.com
 To: joellewea...@hotmail.com; histonet@lists.utsouthwestern.edu
 
 We use Integrated Oncology-Lab Corp, 521 West 57th Street, 6th floor,
 New York, NY 10019 800-447-5816
 
 Josie Britton HT (ASCP) QIHC
 Cheshire Medical Center
 580 Court Street
 Keene, NH 03431
 
 -Original Message-
 From: histonet-boun...@lists.utsouthwestern.edu
 [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of joelle
 weaver
 Sent: Tuesday, May 13, 2014 6:12 PM
 To: histonet@lists.utsouthwestern.edu
 Subject: [Histonet] HER2
 
 Hi Histonetters
 I am looking to compile a list of potential sites do send out Her2
 slides for correlation on a validated assay. I have the Bond, using
 Refine detection. My clone is the Cb11, Oracle. 
 Thanks in advance for any information you can provide. 
 
 
 
 
 Joelle Weaver MAOM, HTL (ASCP) QIHC
  
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RE: [Histonet] Her2 Dual ISH and breast processing

[Hoekert, W.E.J.]

Thank you for the references, 

I have found what I needed in this article:

Minimum Formalin Fixation Time for Consistent Estrogen Receptor 
Immunohistochemical Staining of Invasive Breast Carcinoma. Goldstein NS, et. 
al., Am J Clin Pathol 2003;120:86-92

Willem



My mistake: the web site is: http://www.histosearch.com/rene.html

From: Rene J Buesa rjbu...@yahoo.com
To: Hoekert, W.E.J. w.e.j.hoek...@olvg.nl; vtol...@cox.net 
vtol...@cox.net; histonet@lists.utsouthwestern.edu 



[]



Willem, yes, there are. Look through the attached references which include 
some for breast fixation. There have been some more recently as well, just go 
on scholar.google.com .


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

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RE: [Histonet] Her2 Dual ISH and breast processing

[Hoekert, W.E.J.]

I was wondering,is there any literature on this subject? i.e. the minimal 
required fixation time of breast tissue in order to get reliable immuno 
staining (Oestro, Prog and Her2neu and ISH). We immunologists are alway trying 
to convince our pathologists about the importance of good fixation, but the 
pathologist are always in a hurry to get the diagnosis out. Many mamma biopsies 
do not get to be fixed long enough (some are even put in the processor after a 
few hours of fixation). It would be helpfull if I can show them some literature 
to back me up.
 
Willem



Van: histonet-boun...@lists.utsouthwestern.edu namens Rene J Buesa
Verzonden: ma 10-12-2012 18:23
Aan: vtol...@cox.net; histonet@lists.utsouthwestern.edu
Onderwerp: Re: [Histonet] Her2 Dual ISH and breast processing



Val:
Acknowledging that you have a fixation problem is the fundamental step to 
solving your staining problems.
You state that the slices have now a consistent thickness of between 2-3 mm and 
that is great BUT what about the fixation time?
Thin slices is a first step but until you have the slices properly fixed, you 
will keep having some problems.
Even when one should never assume, I assume that you are using NBF at room 
temperature. With that fixative and under those temperature conditions, your 
2-3 mm thick breast slices will require 4 hours to be fully penetrated; will 
require 24 hours to be 100% covalent bound and will require 96 hours to be 
completely cross-linked.
The 48 hours of maximum exposition to NBF recommended by ASCO-CAP will 
guarantee a 100% cross-linking of 1 mm thick slices, but your 2-3 mm slices 
will require 96 hours to be completely cross-linked.
Until you reach an optimum fixation you will keep having sporadic problems of 
your protocols (depending on greater or lower fat contents of the samples).
René J.

From: vtol...@cox.net vtol...@cox.net
To: histonet@lists.utsouthwestern.edu
Sent: Monday, December 10, 2012 11:48 AM
Subject: [Histonet] Her2 Dual ISH and breast processing

Hello all--

My lab is having some problems with inconstant results with our Her2 Dual ISH 
on the Ventana Ultra.  Right now, we know we have a problem with our large 
breast tissue being under-fixed.  There have been many gripes to the PAs and 
residents about the thickness of the tissue sections and they have listened.  
We are now getting breast sections that are consistently cut between 2-3mm in 
thickness.  However, we are still having issues with inconsistency in our dual 
ISH staining.  Many times, the staining is absent.

We are currently processing our breast tissue on a Tissue-Tek VIP6 processor.  
Are there any labs out there that are using this processor and also running 
Her2 Dual ISH on the Ventana with nice, consistent results?  If so, would any 
of you be willing to share your processing protocol?

Thanks in advance for your help! 



Val



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Re: [Histonet] Her2 Dual ISH and breast processing

[Rene J Buesa]

My mistake: the web site is: http://www.histosearch.com/rene.html


From: Rene J Buesa rjbu...@yahoo.com
To: Hoekert, W.E.J. w.e.j.hoek...@olvg.nl; vtol...@cox.net 
vtol...@cox.net; histonet@lists.utsouthwestern.edu 
histonet@lists.utsouthwestern.edu 
Sent: Thursday, December 13, 2012 10:47 AM
Subject: Re: [Histonet] Her2 Dual ISH and breast processing

Please go to http://www.histosearch.co/rene.html
There are 2 articles on the subject: one about the general fixation issue and 
another about the minimum amount of NBF required to obtain complete fixation.
René J.

From: Hoekert, W.E.J. w.e.j.hoek...@olvg.nl
To: Rene J Buesa rjbu...@yahoo.com; vtol...@cox.net; 
histonet@lists.utsouthwestern.edu 
Sent: Thursday, December 13, 2012 7:35 AM
Subject: RE: [Histonet] Her2 Dual ISH and breast processing

I was wondering,is there any literature on this subject? i.e. the minimal 
required fixation time of breast tissue in order to get reliable immuno 
staining (Oestro, Prog and Her2neu and ISH). We immunologists are alway trying 
to convince our pathologists about the importance of good fixation, but the 
pathologist are always in a hurry to get the diagnosis out. Many mamma biopsies 
do not get to be fixed long enough (some are even put in the processor after a 
few hours of fixation). It would be helpfull if I can show them some literature 
to back me up.

Willem



Van: histonet-boun...@lists.utsouthwestern.edu namens Rene J Buesa
Verzonden: ma 10-12-2012 18:23
Aan: vtol...@cox.net; histonet@lists.utsouthwestern.edu
Onderwerp: Re: [Histonet] Her2 Dual ISH and breast processing



Val:
Acknowledging that you have a fixation problem is the fundamental step to 
solving your staining problems.
You state that the slices have now a consistent thickness of between 2-3 mm and 
that is great BUT what about the fixation time?
Thin slices is a first step but until you have the slices properly fixed, you 
will keep having some problems.
Even when one should never assume, I assume that you are using NBF at room 
temperature. With that fixative and under those temperature conditions, your 
2-3 mm thick breast slices will require 4 hours to be fully penetrated; will 
require 24 hours to be 100% covalent bound and will require 96 hours to be 
completely cross-linked.
The 48 hours of maximum exposition to NBF recommended by ASCO-CAP will 
guarantee a 100% cross-linking of 1 mm thick slices, but your 2-3 mm slices 
will require 96 hours to be completely cross-linked.
Until you reach an optimum fixation you will keep having sporadic problems of 
your protocols (depending on greater or lower fat contents of the samples).
René J.

From: vtol...@cox.net vtol...@cox.net
To: histonet@lists.utsouthwestern.edu
Sent: Monday, December 10, 2012 11:48 AM
Subject: [Histonet] Her2 Dual ISH and breast processing

Hello all--

My lab is having some problems with inconstant results with our Her2 Dual ISH 
on the Ventana Ultra.  Right now, we know we have a problem with our large 
breast tissue being under-fixed.  There have been many gripes to the PAs and 
residents about the thickness of the tissue sections and they have listened.  
We are now getting breast sections that are consistently cut between 2-3mm in 
thickness.  However, we are still having issues with inconsistency in our dual 
ISH staining.  Many times, the staining is absent.

We are currently processing our breast tissue on a Tissue-Tek VIP6 processor.  
Are there any labs out there that are using this processor and also running 
Her2 Dual ISH on the Ventana with nice, consistent results?  If so, would any 
of you be willing to share your processing protocol?

Thanks in advance for your help! 



Val



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Re: [Histonet] Her2 Dual ISH and breast processing

[Rene J Buesa]

Please go to http://www.histosearch.co/rene.html
There are 2 articles on the subject: one about the general fixation issue and 
another about the minimum amount of NBF required to obtain complete fixation.
René J.

From: Hoekert, W.E.J. w.e.j.hoek...@olvg.nl
To: Rene J Buesa rjbu...@yahoo.com; vtol...@cox.net; 
histonet@lists.utsouthwestern.edu 
Sent: Thursday, December 13, 2012 7:35 AM
Subject: RE: [Histonet] Her2 Dual ISH and breast processing

I was wondering,is there any literature on this subject? i.e. the minimal 
required fixation time of breast tissue in order to get reliable immuno 
staining (Oestro, Prog and Her2neu and ISH). We immunologists are alway trying 
to convince our pathologists about the importance of good fixation, but the 
pathologist are always in a hurry to get the diagnosis out. Many mamma biopsies 
do not get to be fixed long enough (some are even put in the processor after a 
few hours of fixation). It would be helpfull if I can show them some literature 
to back me up.

Willem



Van: histonet-boun...@lists.utsouthwestern.edu namens Rene J Buesa
Verzonden: ma 10-12-2012 18:23
Aan: vtol...@cox.net; histonet@lists.utsouthwestern.edu
Onderwerp: Re: [Histonet] Her2 Dual ISH and breast processing



Val:
Acknowledging that you have a fixation problem is the fundamental step to 
solving your staining problems.
You state that the slices have now a consistent thickness of between 2-3 mm and 
that is great BUT what about the fixation time?
Thin slices is a first step but until you have the slices properly fixed, you 
will keep having some problems.
Even when one should never assume, I assume that you are using NBF at room 
temperature. With that fixative and under those temperature conditions, your 
2-3 mm thick breast slices will require 4 hours to be fully penetrated; will 
require 24 hours to be 100% covalent bound and will require 96 hours to be 
completely cross-linked.
The 48 hours of maximum exposition to NBF recommended by ASCO-CAP will 
guarantee a 100% cross-linking of 1 mm thick slices, but your 2-3 mm slices 
will require 96 hours to be completely cross-linked.
Until you reach an optimum fixation you will keep having sporadic problems of 
your protocols (depending on greater or lower fat contents of the samples).
René J.

From: vtol...@cox.net vtol...@cox.net
To: histonet@lists.utsouthwestern.edu
Sent: Monday, December 10, 2012 11:48 AM
Subject: [Histonet] Her2 Dual ISH and breast processing

Hello all--

My lab is having some problems with inconstant results with our Her2 Dual ISH 
on the Ventana Ultra.  Right now, we know we have a problem with our large 
breast tissue being under-fixed.  There have been many gripes to the PAs and 
residents about the thickness of the tissue sections and they have listened.  
We are now getting breast sections that are consistently cut between 2-3mm in 
thickness.  However, we are still having issues with inconsistency in our dual 
ISH staining.  Many times, the staining is absent.

We are currently processing our breast tissue on a Tissue-Tek VIP6 processor.  
Are there any labs out there that are using this processor and also running 
Her2 Dual ISH on the Ventana with nice, consistent results?  If so, would any 
of you be willing to share your processing protocol?

Thanks in advance for your help! 



Val



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Re: [Histonet] Her2 Dual ISH and breast processing

[Rene J Buesa]

Val:
Acknowledging that you have a fixation problem is the fundamental step to 
solving your staining problems.
You state that the slices have now a consistent thickness of between 2-3 mm and 
that is great BUT what about the fixation time?
Thin slices is a first step but until you have the slices properly fixed, you 
will keep having some problems.
Even when one should never assume, I assume that you are using NBF at 
room temperature. With that fixative and under those temperature conditions, 
your 2-3 mm thick breast slices will require 4 hours to be fully penetrated; 
will require 24 hours to be 100% covalent bound and will require 96 hours to be 
completely cross-linked.
The 48 hours of maximum exposition to NBF recommended by ASCO-CAP will 
guarantee a 100% cross-linking of 1 mm thick slices, but your 2-3 mm slices 
will require 96 hours to be completely cross-linked.
Until you reach an optimum fixation you will keep having sporadic problems of 
your protocols (depending on greater or lower fat contents of the samples).
René J.

From: vtol...@cox.net vtol...@cox.net
To: histonet@lists.utsouthwestern.edu 
Sent: Monday, December 10, 2012 11:48 AM
Subject: [Histonet] Her2 Dual ISH and breast processing

Hello all-- 

My lab is having some problems with inconstant results with our Her2 Dual ISH 
on the Ventana Ultra.  Right now, we know we have a problem with our large 
breast tissue being under-fixed.  There have been many gripes to the PAs and 
residents about the thickness of the tissue sections and they have listened.  
We are now getting breast sections that are consistently cut between 2-3mm in 
thickness.  However, we are still having issues with inconsistency in our dual 
ISH staining.  Many times, the staining is absent.

We are currently processing our breast tissue on a Tissue-Tek VIP6 processor.  
Are there any labs out there that are using this processor and also running 
Her2 Dual ISH on the Ventana with nice, consistent results?  If so, would any 
of you be willing to share your processing protocol?

Thanks in advance for your help!  



Val



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RE: [Histonet] Her2 Gastric cases

[Liz Chlipala]

Margaret

Dako has a bunch of info on Her2 staining in gastric cancer its in the
most recent Connection Volume 15 and they also have a companion document
that covers Her 2 staining and scoring for gastric cancer, just go to
the Dako website and you should be able to view these documents. 

Liz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, Colorado 80308
office (303) 682-3949 
fax (303) 682-9060
www.premierlab.com
 
 
Ship to Address:
1567 Skyway Drive, Unit E
Longmont, Colorado 80504

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Coppin,
Margaret
Sent: Friday, March 11, 2011 9:54 AM
To: Histonet@lists.utsouthwestern.edu
Subject: [Histonet] Her2 Gastric cases

Hello,

 

I am hoping someone can shed some light on whether or not Her2 4B5
(Ventana's antibody) is okay to run on gastric biopsies. We are getting
some client requests for this and I wonder if I should re-direct them
toward the Dako Hercep Test instead.

 

Thank you.

 

Margaret G. Coppin, HT(ASCP)

Technical Supervisor--Immunohistochemistry

 

ARUP Laboratories

500 Chipeta Way

Salt Lake City, UT 84108

(801)583-2787 X3869

copp...@aruplab.com

 

 

 


- --
The information transmitted by this e-mail and any included
attachments are from ARUP Laboratories and are intended only for the
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and may constitute inside or non-public information under
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Unauthorized forwarding, printing, copying, distributing, or use of
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Re: [Histonet] Her2 Gastric cases

[Mark Tarango]

We do use the Ventana antibody for gastric cases.  There is some difference
in reading the slide for the pathologist.  I'll send you an article on it in
a seperate e-mail (so I can attach it).

Mark

On Fri, Mar 11, 2011 at 8:54 AM, Coppin, Margaret copp...@aruplab.comwrote:

 Hello,



 I am hoping someone can shed some light on whether or not Her2 4B5
 (Ventana's antibody) is okay to run on gastric biopsies. We are getting
 some client requests for this and I wonder if I should re-direct them
 toward the Dako Hercep Test instead.



 Thank you.



 Margaret G. Coppin, HT(ASCP)

 Technical Supervisor--Immunohistochemistry



 ARUP Laboratories

 500 Chipeta Way

 Salt Lake City, UT 84108

 (801)583-2787 X3869

 copp...@aruplab.com








 - --
 The information transmitted by this e-mail and any included
 attachments are from ARUP Laboratories and are intended only for the
 recipient. The information contained in this message is confidential
 and may constitute inside or non-public information under
 international, federal, or state securities laws, or protected health
 information and is intended only for the use of the recipient.
 Unauthorized forwarding, printing, copying, distributing, or use of
 such information is strictly prohibited and may be unlawful. If you
 are not the intended recipient, please promptly delete this e-mail
 and notify the sender of the delivery error or you may call ARUP
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RE: [Histonet] Her2 Gastric cases

[Jesus Ellin]

Mark can you send me the information as well,  Thanks

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark
Tarango
Sent: Friday, March 11, 2011 10:03 AM
To: Coppin, Margaret
Cc: Histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] Her2 Gastric cases

We do use the Ventana antibody for gastric cases.  There is some
difference
in reading the slide for the pathologist.  I'll send you an article on
it in
a seperate e-mail (so I can attach it).

Mark

On Fri, Mar 11, 2011 at 8:54 AM, Coppin, Margaret
copp...@aruplab.comwrote:

 Hello,



 I am hoping someone can shed some light on whether or not Her2 4B5
 (Ventana's antibody) is okay to run on gastric biopsies. We are
getting
 some client requests for this and I wonder if I should re-direct them
 toward the Dako Hercep Test instead.



 Thank you.



 Margaret G. Coppin, HT(ASCP)

 Technical Supervisor--Immunohistochemistry



 ARUP Laboratories

 500 Chipeta Way

 Salt Lake City, UT 84108

 (801)583-2787 X3869

 copp...@aruplab.com








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 The information transmitted by this e-mail and any included
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 recipient. The information contained in this message is confidential
 and may constitute inside or non-public information under
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 information and is intended only for the use of the recipient.
 Unauthorized forwarding, printing, copying, distributing, or use of
 such information is strictly prohibited and may be unlawful. If you
 are not the intended recipient, please promptly delete this e-mail
 and notify the sender of the delivery error or you may call ARUP
 Laboratories Compliance Hot Line in Salt Lake City, Utah USA at (+1
 (800) 522-2787 ext. 2100
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RE: [Histonet] Her2 Fixation Requirement

[Kim . Donadio]

We adhere the ink with bouins sol'n. Have had no problems. 



Kim Donadio 
Pathology Supervisor
Baptist Hospital
1000 W Moreno St.
Pensacola FL 32501
Phone (850) 469-7718
Fax (850) 434-4996



Rathborne, Toni trathbo...@somerset-healthcare.com 
Sent by: histonet-boun...@lists.utsouthwestern.edu
02/03/2011 04:54 PM

To
Weems, Joyce jwe...@sjha.org, Paula Lucas plu...@biopath.org, 
histonet@lists.utsouthwestern.edu
cc

Subject
RE: [Histonet] Her2 Fixation Requirement






Does anyone have issues with inking the specimen after it has been placed 
in formalin?

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu]On Behalf Of Weems,
Joyce
Sent: Wednesday, February 02, 2011 12:59 PM
To: Paula Lucas; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Her2 Fixation Requirement 


We have the nurse document the time of removal on the requisition. The 
next requisition update will have a spot for this. They have been very 
cooperative and do a good job. 

In addition, you must document the cold ischmic time - that is the time 
from removal until time in formalin. This is important when the specimen 
goes for xray or whatever. So there is a removal time, an into formalin 
time and an out of formalin time. 

Then if we don't have time allowed to meet the fixation time with the 
regular, it is put on a late processor, if we have one available, or it is 
held overnight. And if it has to come off on Sunday, we have a med tech 
remove it from the processor and it waits for us to come on Monday to 
embed it. 

The pathologists document all this time in the report. 

Best! J

Joyce Weems 
Pathology Manager 
Saint Joseph's Hospital 
5665 Peachtree Dunwoody Rd NE 
Atlanta, GA 30342 
678-843-7376 - Phone 
678-843-7831 - Fax 



-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Paula 
Lucas
Sent: Wednesday, February 02, 2011 12:11
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Her2 Fixation Requirement 

Hello histoland
 
I was just given the task to find a solution that is easy and will also 
comply with the CAP guideline for formalin fixation documentation, and so 
I started my research on the Histonet archives.  I found some good 
information, but was hoping to get more feedback. 
 
Would you mind sharing with me the actions you are taking to comply with 
the guideline? 
 
We are a private lab and we provide histology/pathology service for 2 
hospitals and a few surgery centers.  We send our blocks to Genzyme for 
Her2, and we must document on their test order sheet how many hours the 
tissues have been fixed in formalin.
 
I'm assuming I will need to start keeping a log here, with documentation 
that shows what time the tissue was excised and placed in formalin from 
the OR, and then documentation that shows the time it was dissected and 
then placed in the tissue processor. 
 
The problem that I may come across is getting the OR nurse to document the 
time for us.  I don't know...maybe we need to put another sections on our 
requisition form, or maybe something on the formalin container itself for 
the nurse to write on.  It'll be a hassle at first but if I can get the 
hospitals lab director involved, I'm sure it will work itself out.
 
Anyway, if you wouldn't mind sharing some of your ideas, I would really 
appreciate it.
 
Paula Lucas
Lab Manager
Bio-Path Medical Group
Fountain Valley, CA
 

 

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RE: [Histonet] Her2 Fixation Requirement

[Rathborne, Toni]

Does anyone have issues with inking the specimen after it has been placed in 
formalin?

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu]On Behalf Of Weems,
Joyce
Sent: Wednesday, February 02, 2011 12:59 PM
To: Paula Lucas; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Her2 Fixation Requirement 


We have the nurse document the time of removal on the requisition. The next 
requisition update will have a spot for this. They have been very cooperative 
and do a good job. 

In addition, you must document the cold ischmic time - that is the time from 
removal until time in formalin. This is important when the specimen goes for 
xray or whatever. So there is a removal time, an into formalin time and an out 
of formalin time. 

Then if we don't have time allowed to meet the fixation time with the regular, 
it is put on a late processor, if we have one available, or it is held 
overnight. And if it has to come off on Sunday, we have a med tech remove it 
from the processor and it waits for us to come on Monday to embed it. 

The pathologists document all this time in the report. 

Best! J

Joyce Weems 
Pathology Manager 
Saint Joseph's Hospital 
5665 Peachtree Dunwoody Rd NE 
Atlanta, GA 30342 
678-843-7376 - Phone 
678-843-7831 - Fax 



-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Paula Lucas
Sent: Wednesday, February 02, 2011 12:11
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Her2 Fixation Requirement 

Hello histoland
 
I was just given the task to find a solution that is easy and will also comply 
with the CAP guideline for formalin fixation documentation, and so I started my 
research on the Histonet archives.  I found some good information, but was 
hoping to get more feedback. 
 
Would you mind sharing with me the actions you are taking to comply with the 
guideline?  
 
We are a private lab and we provide histology/pathology service for 2 hospitals 
and a few surgery centers.  We send our blocks to Genzyme for Her2, and we must 
document on their test order sheet how many hours the tissues have been fixed 
in formalin.
 
I'm assuming I will need to start keeping a log here, with documentation that 
shows what time the tissue was excised and placed in formalin from the OR, and 
then documentation that shows the time it was dissected and then placed in the 
tissue processor.  
 
The problem that I may come across is getting the OR nurse to document the time 
for us.  I don't know...maybe we need to put another sections on our 
requisition form, or maybe something on the formalin container itself for the 
nurse to write on.  It'll be a hassle at first but if I can get the hospitals 
lab director involved, I'm sure it will work itself out.
 
Anyway, if you wouldn't mind sharing some of your ideas, I would really 
appreciate it.
 
Paula Lucas
Lab Manager
Bio-Path Medical Group
Fountain Valley, CA
 

 

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It may contain information that is privileged and 
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not the intended recipient, please delete this message, and 
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Re: [Histonet] Her2 Fixation Requirement

[BSullivan]

We receive our lumpectomies and total breasts  fresh. They are immediately
put in 10 % formalin if no frozen is required and that time is noted on our
requisition. Our processing time for formalin and the fixation time is made
part of the final report. If we receive a  breast biopsy specimen we have
asked that they write the time on the requistion that the specimen was
placed in 10 % formalin. We set up a procedure that states this.

Beatrice Sullivan, HT(A.S.C.P.) HTL , AAS, CLSP(N.C.A.)
AP Supervisor
Shore Memorial Hospital
609-653-3590


Speak only well of people and you need never whisper


   
 Paula Lucas 
 plucas@biopath.o 
 rgTo 
 Sent by:  histonet@lists.utsouthwestern.edu 
 histonet-bounces@  cc 
 lists.utsouthwest 
 ern.edu   Subject 
   [Histonet] Her2 Fixation
   Requirement 
 02/02/2011 12:11  
 PM
   
   
   
   




Hello histoland

I was just given the task to find a solution that is easy and will also
comply with the CAP guideline for formalin fixation documentation, and so I
started my research on the Histonet archives.  I found some good
information, but was hoping to get more feedback.

Would you mind sharing with me the actions you are taking to comply with
the
guideline?

We are a private lab and we provide histology/pathology service for 2
hospitals and a few surgery centers.  We send our blocks to Genzyme for
Her2, and we must document on their test order sheet how many hours the
tissues have been fixed in formalin.

I'm assuming I will need to start keeping a log here, with documentation
that shows what time the tissue was excised and placed in formalin from the
OR, and then documentation that shows the time it was dissected and then
placed in the tissue processor.

The problem that I may come across is getting the OR nurse to document the
time for us.  I don't know...maybe we need to put another sections on our
requisition form, or maybe something on the formalin container itself for
the nurse to write on.  It'll be a hassle at first but if I can get the
hospitals lab director involved, I'm sure it will work itself out.

Anyway, if you wouldn't mind sharing some of your ideas, I would really
appreciate it.

Paula Lucas
Lab Manager
Bio-Path Medical Group
Fountain Valley, CA




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RE: [Histonet] Her2 Fixation Requirement

[Weems, Joyce]

We have the nurse document the time of removal on the requisition. The next 
requisition update will have a spot for this. They have been very cooperative 
and do a good job. 

In addition, you must document the cold ischmic time - that is the time from 
removal until time in formalin. This is important when the specimen goes for 
xray or whatever. So there is a removal time, an into formalin time and an out 
of formalin time. 

Then if we don't have time allowed to meet the fixation time with the regular, 
it is put on a late processor, if we have one available, or it is held 
overnight. And if it has to come off on Sunday, we have a med tech remove it 
from the processor and it waits for us to come on Monday to embed it. 

The pathologists document all this time in the report. 

Best! J

Joyce Weems 
Pathology Manager 
Saint Joseph's Hospital 
5665 Peachtree Dunwoody Rd NE 
Atlanta, GA 30342 
678-843-7376 - Phone 
678-843-7831 - Fax 



-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Paula Lucas
Sent: Wednesday, February 02, 2011 12:11
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Her2 Fixation Requirement 

Hello histoland
 
I was just given the task to find a solution that is easy and will also comply 
with the CAP guideline for formalin fixation documentation, and so I started my 
research on the Histonet archives.  I found some good information, but was 
hoping to get more feedback. 
 
Would you mind sharing with me the actions you are taking to comply with the 
guideline?  
 
We are a private lab and we provide histology/pathology service for 2 hospitals 
and a few surgery centers.  We send our blocks to Genzyme for Her2, and we must 
document on their test order sheet how many hours the tissues have been fixed 
in formalin.
 
I'm assuming I will need to start keeping a log here, with documentation that 
shows what time the tissue was excised and placed in formalin from the OR, and 
then documentation that shows the time it was dissected and then placed in the 
tissue processor.  
 
The problem that I may come across is getting the OR nurse to document the time 
for us.  I don't know...maybe we need to put another sections on our 
requisition form, or maybe something on the formalin container itself for the 
nurse to write on.  It'll be a hassle at first but if I can get the hospitals 
lab director involved, I'm sure it will work itself out.
 
Anyway, if you wouldn't mind sharing some of your ideas, I would really 
appreciate it.
 
Paula Lucas
Lab Manager
Bio-Path Medical Group
Fountain Valley, CA
 

 

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for the sole use of the intended recipient(s).  
It may contain information that is privileged and 
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RE: [Histonet] Her2 Fixation Requirement

[Lori.Disher]

  What is the appropriate time it should be in formalin?  Do you start your 
time when it is initially put into formalin, or the start from the time it was 
dissected?

Lori A Disher
Fawcett Memorial Hospital
Port Charlotte,  FL   33952
lori.dis...@hcahealthcare.com

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RE: [Histonet] Her2 Fixation Requirement

[Liz Chlipala]

Lori

 

I would think both if you could since the Her2 paper does address those
issues as potentials for problems in testing variation (time to
fixation).  I believe the CAP/ASCO paper states not less then 6 and no
more than 48 hours for fixation (2007 paper).  I believe you also should
document type of fixative if possible; vendor, lot number and expiration
date if you can.  I have pdfs of these documents if you need them.

 

Liz

 

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC

Manager

Premier Laboratory, LLC

PO Box 18592

Boulder, Colorado 80308

office (303) 682-3949 

fax (303) 682-9060

www.premierlab.com

 

 

Ship to Address:

1567 Skyway Drive, Unit E

Longmont, Colorado 80504

 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of
lori.dis...@hcahealthcare.com
Sent: Wednesday, February 02, 2011 12:16 PM
To: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Her2 Fixation Requirement

 

  What is the appropriate time it should be in formalin?  Do you start
your time when it is initially put into formalin, or the start from the
time it was dissected?

 

Lori A Disher

Fawcett Memorial Hospital

Port Charlotte,  FL   33952

lori.dis...@hcahealthcare.com

 

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RE: RE: [Histonet] Her2 Fixation Requirement

[Weems, Joyce]

Formalin time is no less than 6 and no more than 48 hours. You need to document 
time from excision to time in formalin - cold ischemic time - and time in 
formalin. 

New regs extended fixation time for ER/PR to 72 hours, but since it's all in 
there together, you can't go by that yet. And for patient's to be eligible for 
many clinical trials, 10% NBF is the only fixative that should be used. j  

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of 
lori.dis...@hcahealthcare.com
Sent: Wednesday, February 02, 2011 14:16
To: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Her2 Fixation Requirement

  What is the appropriate time it should be in formalin?  Do you start your 
time when it is initially put into formalin, or the start from the time it was 
dissected?

Lori A Disher
Fawcett Memorial Hospital
Port Charlotte,  FL   33952
lori.dis...@hcahealthcare.com

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not the intended recipient, please delete this message, and 
reply to the sender regarding the error in a separate email.


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RE: [Histonet] Her2 Fixation Requirement

[Chiriboga, Luis]

I believe the two most recent articles from ASCO/CAP on this subject are

Hammond, M.E., D.F. Hayes, M. Dowsett, D.C. Allred, K.L. Hagerty, S. Badve, 
P.L. Fitzgibbons, G. Francis, et al. 2010. American Society of Clinical 
Oncology/College Of American Pathologists guideline recommendations for 
immunohistochemical testing of estrogen and progesterone receptors in breast 
cancer. J Clin Oncol 28:2784-2795.

Wolff, A.C., M.E. Hammond, J.N. Schwartz, K.L. Hagerty, D.C. Allred, R.J. Cote, 
M. Dowsett, P.L. Fitzgibbons, et al. 2007. American Society of Clinical 
Oncology/College of American Pathologists guideline recommendations for human 
epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 
25:118-145.

If you do not have access to the literature you can request reprints from the 
authors or it may be available on the ASCO website?

Luis









-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Liz Chlipala
Sent: Wednesday, February 02, 2011 2:28 PM
To: lori.dis...@hcahealthcare.com; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Her2 Fixation Requirement

Lori

 

I would think both if you could since the Her2 paper does address those
issues as potentials for problems in testing variation (time to
fixation).  I believe the CAP/ASCO paper states not less then 6 and no
more than 48 hours for fixation (2007 paper).  I believe you also should
document type of fixative if possible; vendor, lot number and expiration
date if you can.  I have pdfs of these documents if you need them.

 

Liz

 

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC

Manager

Premier Laboratory, LLC

PO Box 18592

Boulder, Colorado 80308

office (303) 682-3949 

fax (303) 682-9060

www.premierlab.com

 

 

Ship to Address:

1567 Skyway Drive, Unit E

Longmont, Colorado 80504

 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of
lori.dis...@hcahealthcare.com
Sent: Wednesday, February 02, 2011 12:16 PM
To: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Her2 Fixation Requirement

 

  What is the appropriate time it should be in formalin?  Do you start
your time when it is initially put into formalin, or the start from the
time it was dissected?

 

Lori A Disher

Fawcett Memorial Hospital

Port Charlotte,  FL   33952

lori.dis...@hcahealthcare.com

 

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Re: [Histonet] her2 validation

[Pat Laurie]

We left it up to our pathologist. Initially we did the 25 slide validation,
our pathologist wasn't 100% convinced that he could read them accurately, so
we did another 25, plus all of the ones we sent out which already had FISH
ran.  It ended up being almost 70 cases, and our pathologist was properly
educated on how he should score them.  He felt that there was excessive
pressure put on the pathologists due to having to score these slides, not
just say negative or positive.  I'll say though for the last year or so,
with about 6 her2 cases ran a day, he has been remarkably accurate.  Any
that he scores 2+ and has sent out for FISH he usually indicates if he
thinks that it will be positive or negative.  He has yet to be wrong.
Another Pathologist who I talked to who helped set up the guidelines said
that there isn't a 1 method fits all process.  Good luck.

On Tue, Mar 30, 2010 at 7:19 AM, anita dudley azdud...@hotmail.com wrote:


 sorry!!!  I didn't put a subject in the previous post.  wondering about how
 many slides people are using for her2 validation.  thanks



 anita dudley

 providence hospital

 mobile alabama

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PH: 206-215-5949
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RE: [Histonet] Her2 fixation question

[Carol Fields]

Thank you all for help with the Her 2 policy.  I was really stuck
writing the processing piece.  I was able to finish the policy now
to get our docs to pass it.
THX again for the great help!
Carole

Carole Fields, HT (ASCP)
Histology Supervisor
Northside Hospital
Atlanta, GA 30342
carol.fie...@northside.com

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Shirley
A. Powell
Sent: Thursday, October 29, 2009 5:17 PM
To: Histonet (histonet@lists.utsouthwestern.edu)
Subject: [Histonet] Her2 fixation question

I am sending this email for a friend who is having problems posting to
histonet right now.  Please reply to her at
carol.fie...@northside.commailto:carol.fie...@northside.com and not
me.

From Carol Fields
She writes:


Hi Netters,

I am attempting to write a processing schedule (VIP) for  breast bx's
and breast tx for Her2 fixation.  We send the blocks out for testing but
I cannot get my brain around this schedule for the processing piece.
The lab is 24 hours with only one person from 7pm until 10 pm.  We work
weekends also.  Would someone please let me know how they schedule the
fixation and processing of these specimens.
Any help with this is greatly appreciated.
Thank you,
Carole



Carole Fields, HT (ASCP)
Histology Supervisor
Northside Hospital
Atlanta, GA 30342
carol.fie...@northside.commailto:carol.fie...@northside.com





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Re: [Histonet] HER2 on upper GI biopsies

[Mark Tarango]

We've been getting these requests lately too.  I've been wondering if we
need to monitor fixation time for these specimens, since Her2neu is a
possibility.

Mark Tarango

On Mon, Nov 2, 2009 at 9:44 AM, Maray Weirauch mweira...@crittenton.comwrote:

 We have had some oncologists asking for HER2 by IHC then reflexing for FISH
 if the IHC is negative or equivocal on upper GI tumors.
 Our pathologists have been lookin for a recommended guideline to reflex for
 negatives in these types of cases, but haven't found any -- is anyone aware
 of FISH testing guidelines on GI cases?
 Thanks in advance!



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Re: [Histonet] Her2/Neu Valadation

[Rene J Buesa]

Amy:
The question has the answer in itself. You have to do the comparisons in the 
amount recommended between results in your lab vs. in other labs. That is what 
a validation requires.
René J.

--- On Tue, 11/4/08, Amy Self [EMAIL PROTECTED] wrote:

From: Amy Self [EMAIL PROTECTED]
Subject: [Histonet] Her2/Neu Valadation
To: histonet@lists.utsouthwestern.edu
Date: Tuesday, November 4, 2008, 11:09 AM

Dear Histonetters,

 

How are you handling/answering the following question from the CAP
checklist?

 

Thanks in advance,

Amy

 

Georgetown Hospital System

843-527-7179

 

 

**NEW**   09/27/2007

 

ANP.22997 Phase I
N/A   YES   NO

 

If the laboratory assesses HER2 protein over-expression by
immunohistochemistry (IHC) or HER2 gene amplification by fluorescence in
situ hybridization (FISH), has the laboratory documented appropriate
validation for the assay(s)?  

 

NOTE:  Initial test validation must be performed on a minimum of 25
cases (recommended 25-100). Validation may be performed by comparing the
results of testing with a validated alternative method (i.e., IHC vs.
FISH) either in the same laboratory or another laboratory, or with the
same validated method performed in another laboratory; validation
testing must be done using the same set of cases in both labs.

 

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