[Histonet] validation documentation for processors

[Rene J Buesa]

As all validations, you will have to process at least 25 pieces (CAP requires from 25 to 100) of tissue using your old and your new processor simultaneously. Make slides and later prepare H&E and some HC and  IHC procedures using both sets of slides and give them to as many pathologists as you can so they can select, without knowing which section comes from which processor, with only two options: either one section is better than the other, or both are equivalent for diagnostic purposes.
Later your data should be analyzed statistically with the chi-square test or you could obviate the test if almost (more than 90%) of all the pairs are qualified as equivalent.
René J.

--- On Tue, 3/10/09, Joseph Fear <fearj <@t> bronsonhg.org> wrote:

From: Joseph Fear <fearj <@t> bronsonhg.org>
Subject: [Histonet] validation documentation for processors
To: histonet <@t> lists.utsouthwestern.edu
Date: Tuesday, March 10, 2009, 4:45 PM

A question came up in our lab about validation documentation for our new
processor. 
Does anyone have any creative feedback on how your lab documents validation of
machines like processors and stainers? 

See below---->

>>>Joseph Fear 03/01/09>>>
I'll post the question at histonet and see what i can find out about how
other histo labs document validation of thier machines. 

I think with the peloris we ran test cases and Dr.Pearson checked the H&E
slides, but you're right that we don't have documentation of what cases
were run and with JP's signiture for approval of validation. I can work on a
general 'machine validation form' in excel and get back with you.

-Joseph

>>> Virginia Rupert 02/20/09 3:44 PM >>>
In your searches, or past experience, do you know or can you find out how new
instruments are validated? I don't think we have adequate documentation for
the Peloris, with test cases, etc. But I also haven't found a document to
use as a template for our purposes. Any ideas?
Thanks

 

 

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