[Histonet] Special stains

Tue Jan 5 12:21:04 CST 2010

Rene

I'm sorry but I'm going to have to disagree with you on this one.  But I'm coming from a GLP lab.  Different stainers stain differently.  We have two different brands of IHC stainers and even with most of the same reagents (rinse buffers are different) the staining comes out different on each one with basically the same protocol. Plus in a GLP lab we have to validate the stainer itself.  All of our equipment has been validated and when we moved to our new location we had to re validate everything again. Our validation protocols are about 50 to 70 pages long for each of the IHC stainers we have, along with validation of the PT links, with data tracers for temp, etc.  Not a simple task, but it needs to be done.  Once I have a GLP IHC protocol in place I can't change any equipment or reagents without revalidating the procedure.  It might be different in clinical but in the GLP world I would revalidate the special stains also. It should not be that difficult to do, just stain a couple control slides and determine if the staining is correct and document it.  A one page sheet could be created for each stain (document vendor, lot numbers and exp date of reagents, serial number of stainer, date performed, person performing the staining, what control slides were used and then the slides should be reviewed by the tech that stained it and then the pathologist, record date reviewed with initials, comments, etc.  I don't think much more would be needed for specials.  IHC would be different, more slides for validation, additional paperwork is required. There is a paper out there on recommendations on how to validate IHC staining.  I have a pdf of it if anyone is interested.  That's just my two cents, but I have the tendency to do more than to do less, since the last thing I need is a 483 from the FDA when they come and visit.

Liz 

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, Colorado 80308
office (303) 682-3949 
fax (303) 682-9060
www.premierlab.com

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-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Tuesday, January 05, 2010 10:38 AM
To: 'histonet <@t> lists.utsouthwestern.edu'; Dorothy LWebb
Subject: Re: [Histonet] Special stains

Dorothy:
I would NOT do it.
If you do not change the procedure it does not really matter which auto stainer you use. Your "validation" is the reaction of your control that should react as before.
As a matter of fact, I would be more inclined to made a validation if you change your control rather than if you change the auto stainer.
If, for example, you are doing IHC and your dilution has been "fine tuned" for a given tissue control and you change the tissue, you will need to "fine tune" the dilution to have the same reaction strength of the epitope in the new control, but you will not have to change your procedure. That is why I always used IHC internal controls, and by using "normal strength epitopes" I don't have to keep validating.
That is also why I always shied away from using pathological cases to use as epitope controls.
So, I would not advise you to go through validation because of changing the auto stainer, as long as the procedure is the same.
René J.

--- On Tue, 1/5/10, Webb, Dorothy L <Dorothy.L.Webb <@t> HealthPartners.Com> wrote:

From: Webb, Dorothy L <Dorothy.L.Webb <@t> HealthPartners.Com>
Subject: [Histonet] Special stains
To: "'histonet <@t> lists.utsouthwestern.edu'" <histonet <@t> lists.utsouthwestern.edu>
Date: Tuesday, January 5, 2010, 12:23 PM

We are switching automated special stain equipment to a different vendor and am wondering if we have to validate all of the special stains we do.  I am from the "old school" and the validation process, other than IHC, is not my forte!!  Any advice would be appreciated, so, thanks ahead of time!!

Dorothy Webb, Ht (ASCP)
Regions Histology Technical Supervisor
651-254-2962

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