Hi Dawn,

I would suggest having a look at this CAP guidance paper, below.  If I can be 
of any assistance, please feel free to contact me. 

1. Patrick, L. F. et al. Principles of analytic validation of 
immunohistochemical assays: Guideline from the College of American Pathologists 
Pathology and Laboratory Quality Center. Arch. Pathol. Lab. Med. 138, 1432–1443 
(2014).


Regan

Regan Fulton, MD/PhD
PhenoPath
551 North 34th Street, Suite 100
Seattle, WA 98103
Phone 206-374-9000   


CEO, Array Science, LLC
475 Gate 5 Road, #102
Sausalito, CA 94965



> On Feb 27, 2018, at 8:34 AM, Olszewski, Dawn via Histonet 
> <histonet@lists.utsouthwestern.edu> wrote:
> 
> Good morning Histo Peeps,
> 
> I was wondering if anyone would be willing to share their protocol on 
> antibody validation for the IHC lab on FFPE tissues.  Do you know if there 
> are specific regulations on validation or does each lab/hospital develop 
> their own methods.  We are no longer under CAP for inspections,  but we are 
> inspected by Joint Commission.
> 
> If you know of specific regulations could you please site them.  We seem to 
> be in disagreement on how this should be done in our lab.
> Thanks for any and all advice in advance.
> 
> Sincerely,
> 
> Dawn Olszewski, HTL(ASCP)QIHC
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