[Histonet] Responses to IHC CAP Validation question

[Liz Chlipala]

CAP does have guidelines, it's a paper that was published a few years
back, its right on the CAP website.  I have it if anyone needs it.  I'm
not sure they use it for their inspections but it covers how to validate
an antibody.  How many samples to run, what paperwork needs to be kept,
etc.

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
 
 
Ship to Address:
1567 Skyway Drive, Unit E
Longmont, Colorado 80504

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From: histonet-bounces <@t> lists.utsouthwestern.edu
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Sent: Wednesday, April 28, 2010 12:47 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Responses to IHC CAP Validation question



The following is one respone I rec'd:
 
1.  I asked CAP who told me that they do not currently have a guideline
on
validating but that they
recommend what is in the following book:
Quality Management In Anatomic Pathology, Promoting Patient Safety
Through Systems Improvement and Error
by Raouf E. Nakhleh, MD & Patrick Fitzgibbons, MD editors
sold by CAP !
Chapter 8- Quality Management in IHC
That is what we follow.
I. Get a new antibody and optimize it with your positive control.
II. Once optimized you need to run it on cases expected to be positive
(how many?)
"a suffient size ..."
III. Must also be run on cases expected to be negative. (how many?
IV. In a situation where you cannot expect a lot of cases or such a
case has
never been presented in your lab, then you must say just that.
(ex. some of the hormones we just use a pituitary)
 
 





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