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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