{SPAM?} RE: [Histonet] Ohh the pain

Thu Sep 27 09:12:31 CDT 2007

Under the CAP/ASCO guidelines it reads "Any alteration of standard
conditions, such as use of alternative fixatives, microwave fixation, or
alternative processing methods, must be validated against standard methods
of testing before a test routinely using these conditions is offered in a
laboratory. Validation must consist of testing of the same samples with the
alternative fixative buffered formalin using the same Her2 testing method to
demonstrate concordance of the result". 

If there is more to it then please point me to the correct references. 

Douglas D. Deltour HT(ASCP)
Histology Manager
Professional Pathology Services, PC
One Science Court
Suite 200
Columbia, SC 29203
Office (803)252-1913
Fax (803)254-3262
Doug <@t> ppspath.com 
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PROFESSIONAL PATHOLOGY SERVICES, PC
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-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Weems, Joyce
Sent: Thursday, September 27, 2007 7:51 AM
To: Douglas D Deltour; Amos Brooks; histonet <@t> lists.utsouthwestern.edu
Subject: {SPAM?} RE: [Histonet] Ohh the pain

Remember that FDA requires formalin fixation for Her2/Neu testing, if this
affects you at all..

Joyce Weems
Pathology Manager
Saint Joseph's Hospital 
5665 Peachtree Dunwoody Rd NE
Atlanta, GA 30342
404-851-7376 - Phone
404-851-7831 - Fax

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu]On Behalf Of Douglas D
Deltour
Sent: Thursday, September 27, 2007 8:51 AM
To: 'Amos Brooks'; histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] Ohh the pain

You are preaching to the choir Amos. Believe me, this is not my idea. 

Douglas D. Deltour HT(ASCP)
Histology Manager
Professional Pathology Services, PC
One Science Court
Suite 200
Columbia, SC 29203
Office (803)252-1913
Fax (803)254-3262
Doug <@t> ppspath.com 
*****************************************************
PROFESSIONAL PATHOLOGY SERVICES, PC
NOTICE OF CONFIDENTIALITY
This message is intended only for the use of the individual or entity to
which it is addressed and may contain information that is privileged,
confidential and exempt from disclosure under applicable law. If the reader
of this message is not the intended recipient, you are hereby notified that
any dissemination, distribution, or copying of this communication is
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error, please notify me immediately.

-----Original Message-----
From: Amos Brooks [mailto:amosbrooks <@t> gmail.com] 
Sent: Wednesday, September 26, 2007 5:15 PM
To: doug <@t> ppspath.com; histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Ohh the pain

Douglas,
     I've really gotta write this up someday and save it so I can just
cut & paste it every time someone winds me up on this rant. I'll keep
it gentle  or try to at least! :-)
     The premise of my argument is that no lab is an island. If you
use a fixative that is different from everyone else then all
subsequent steps, from cutting to staining are different. Different
fixatives alter the tissue in different ways. So, if you fix the same
piece of tissue as another person in another lab, and you each use a
different fixative, formalin or not, subsequent testing may be
drastically different.
     So you need to ask a few questions in this process. Is all the
tissue you process going to be fixed in the new fixative, if not, how
will you be able to tell them apart? Are you going to be sending ANY
tissue out to other institutions for testing? If so how do they know
how you fixed it and do they have the capabilities to handle tissue
fixed in various ways? Are you going to recieve tissue from another
institution, and if so how do you test it if all your testing is based
upon the alternative fixation technique?
     Do you have any archive tissue, if so how does the results of the
new tests correlate to the same tests on archived tissue. What do you
use as control tissue for both tests. How does the fixative affect any
future clinical studies?
     Granted there will be some tests that changing the fixative will
have no effect on. Alternative fixative vendors would show you they
can get many tests to work fine. When hearing this just think about
the above questions. I've heard many good answers to one or two of
them. I've never heard of anyone able to answer ALL of them!
     It may be a great idea to dump formalin as a fixative in favor of
another. I think the only way to do it properly is to unanamously
choose ONE fixative and use it as the standard in most if not all labs
in the country if not the world. Sounds nice right? Standardization of
testing begins here. Now ask what's in the fixative ... OOH that's a
proprietary secret! So much for standardization! Until these pompous
money grubbing fools that sell this snake oil loosen up and start
making the formulations 'open source' formalin will remain the
industry standard.

Just my $0.02 (again),
Amos Brooks

PS: I hope I haven't offended anybody with the ferocity of any of the
above statements. I like sales people, I like most of these companies.
I don't like policies that put the dollar sign before the patient and
the science used to save them.

Date: Wed, 26 Sep 2007 16:37:25 -0500
From: "Douglas D Deltour" <doug <@t> ppspath.com>
Subject: [Histonet] Ohh the pain (replacing formalin)
To: <histonet <@t> lists.utsouthwestern.edu>
Message-ID:
       <mailman.1037.1190839308.2071.histonet <@t> lists.utsouthwestern.edu>
Content-Type: text/plain;       charset="us-ascii"

I have found a suitable replacement for xylene but that is the easy part.

I now have been directed to start looking for a formalin substitute. I am
not aware of anyone that actually uses the stuff (probably for good reason).
Does anyone know of or have any experience with these alternative (inferior)
products? Does anyone have any experience with the validation (headache)
required to actually replace formalin? I can hardly wait. Thanks.

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