[Histonet] Validation of a new tissue processor

[Rene J Buesa]

Absolutely agree with Tim's comments. 
I would even add that if the new tissue processor uses the "standard" heat/agitation/vacuum/pressue sequences as the old one, the validation objective is mainly directed to have some documentation that the facility's attorneys can have in case "something goes wrong" and the plaintiff's attorney asks: "Was the instrument validated?" avoiding that a judge, also ignorant of our methods, rules against our lab.
The validation is really necessary if the processing technology goes from the "conventional" to the microwave technology where the times are so different and the development of new quality protocols are of paramount importance. 
The one who has to decide about the validation test is the pathologist and his acceptance has to go to the QC file, and that's it!
René J. 

From: "Morken, Timothy" <Timothy.Morken <@t> ucsfmedctr.org>
To: "'histonet <@t> lists.utsouthwestern.edu'" <histonet <@t> lists.utsouthwestern.edu> 
Sent: Wednesday, November 28, 2012 5:10 PM
Subject: RE: [Histonet] Validation of a new tissue processor

I don't think it is necessary to test every single stain or antibody you do to validate a new tissue processor. Most of the time the only thing changing is the machine, not the chemicals you use. The point of validation is to prove that the system gives you the same results as the old instrument. Using a representative sample of types of stains and antibodies will give you confidence that it works fine and save a huge amount of money and time. 

Think about it from this perspective: We get paraffin slides and blocks from consult cases from all over the place, processed on many different machines with infinitely variable time and chemical protocols. Yet virtually all the cases work fine in our immuno staining system. It is rare to find cases that do not. That alone tells you that massive validation is not really necessary.

The point of a validation procedure is to plan one that you feel will give you confidence that the new instrument gives you the same results as the old one. If you do insist on testing "all" your antibodies (we have over 200 here) then tissue arrays or multiple tissue blocks will save a lot of time and money. 

Of course, if you go to a new processor that uses totally different  types of chemicals and methods then validation of every antibody may be necessary. Even then, however, representative markers of various types may suffice. 

Tim Morken
Department of Pathology
UC San Francisco Medical Center


-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Helen Fedor
Sent: Wednesday, November 28, 2012 1:51 PM
To: 'Rene J Buesa'; Howe, Helena; 'histonet <@t> lists.utsouthwestern.edu'
Subject: RE: [Histonet] Validation of a new tissue processor

You will also need to validate all of the IHC stains and special stains that you do on these tissues. You can take samples from each tissue type and run them in parallel on both machines. Then test all of your special stains and antibodies that you have in your inventory.

:)
Helen

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Wednesday, November 28, 2012 4:47 PM
To: Howe, Helena; 'histonet <@t> lists.utsouthwestern.edu'
Subject: Re: [Histonet] Validation of a new tissue processor

Using at least 25 different types of tissues, prepare parallel almost identical pairs of slices for each tissue and process them simultaneously in your new tissue processor and in the old one.
Prepare H&E sections and give them to the pathologists concealing the used tissue processor. The pathologists should decide if there are differences between the pairs of sections.
The pathologist's opinion should be registered in the QC file and that will be your validation.
René J.

From: "Howe, Helena" <Helena.Howe <@t> ProMedica.org>
To: "'histonet <@t> lists.utsouthwestern.edu'" <histonet <@t> lists.utsouthwestern.edu> 
Sent: Wednesday, November 28, 2012 2:57 PM
Subject: [Histonet] Validation of a new tissue processor

Does anyone know what the CAP is requiring to validate a new tissue processor?
Thank You
Helena Howe
ProMedica Laboratories
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