[Histonet] validation documentation for processors

[Michael LaFriniere]

Rene,
 
I agree with your process as to validation, however, could you help me
understand where does the CAP state (what check off list item)
concerning validation requirements when changing out processors or
processing technologies. My staff is currently performing the validation
process with a large microwave processor. If CAP does have a
recommendation I would appreciate seeing it. I have a (1) out of (12)
pathologists that (I think is going overboard) who would like my
Pathology Manager to perform over 100 tissue samples for validation
process to include IHC/FISH/special staining as we make the switch from
conventional to microwave processing.....
 
Thanks!
 
Michael

 
 
Michael R. LaFriniere
Executive Director
Cytology Services of Maryland (CSM)
301-206-2555 ext 27      301-206-2595 fax
michael.lafriniere <@t> csmlab.com


>>> On 3/10/2009 at 5:23 PM, Rene J Buesa <rjbuesa <@t> yahoo.com> wrote:
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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