While I do primarily IHC/ISH, I think the validation would be similar. I
don't believe that a vendor can do your validation. The vendor can validate
that their instrument is performing per it's specs, but that is NOT the same
as validating the test. To validate the test you need to prove sensitivity &
specificity with your patient specimens. This involves knowing what this
test should & should not be positive on, having references to this pattern
of staining,  running a series of both positive & negative cases,  writing
this up explaining your results, etc... Then the test is validated for your
facility with your patient population. Just my thoughts on the subject.

Patti Loykasek
PhenoPath Laboratories
Seattle, WA






> We recently went from manual special stains to automated special stains.  We
> correlated every stain with 3-5 old cases and one pathologist signed off on
> these.  Things have been so hectic these last several months that a
> validation procedure has not been written down. I had read recently in CAP
> that this needs written documentation, etc.  Does anyone have a validation
> procedure that they would be willing to share?  I would be most grateful.
> Thanks!!!
> Paula Wilder
> St. Joseph Medical Center
> Towson, MD 21204
> 
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