CAP has a "suggestion" for a validation protocol BUT the most important thing 
is the acceptance of your processed tissues by the pathologist. S/he will be 
the ultimate responsible in the validation process.
Ideally, you should run parallel samples with the instrument you are using now 
and the Peloris. The number varies. You will also have to do IHC in some of the 
samples run with the Peloris. Select those IHC of greater importance and most 
frequent use. Ask your pathologist which s/he wants.
In all these validations do not try to do it by yourself, always ask the 
pathologists what s/he wants to do. 
At first glance validation seems to be a daunting task but it is not if you 
follow your pathologists' indications.
Document the whole process and make sure to have the pathologist's signature on 
the evaluation of the slides and procedures. Archive those blocks and slides 
for future reference.
That is how I did all my validations even when I was developing new processing 
protocols.
René J.

--- On Thu, 3/29/12, Michelle Wahlsten <mwahls...@yahoo.com> wrote:


From: Michelle Wahlsten <mwahls...@yahoo.com>
Subject: [Histonet] Leica Peloris II processor validation
To: "Histonet@lists.utsouthwestern.edu" <Histonet@lists.utsouthwestern.edu>
Date: Thursday, March 29, 2012, 9:30 PM


Hi everyone, 

I'm currently in process of validating the Peloris II for our lab, my first 
instrument validation so I'm a bit lost as to what specifically I need to do 
and document.  Other than running specimens through the specific protocols to 
verify the quality of the specimen with a pathologist's review and/or sign-off, 
I feel that there is more that I need to do but I'm not sure what that is.  Can 
anyone share with me their experience of the validation process and/or 
suggestions as to what else I need or what I'm missing??

In addition to the instrument validation itself, we also need to validate IHC 
use on the Peloris, per one of our pathologist's.  How many antibodies, 
controls or panels should we be doing to satisfy the 'validation' process for 
IHC??  Any information will be helpful, thank you so much!!

Michelle Wahlsten, HTL
University of Minnesota Medical Center, Fairview
Minneapolis, MN

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