[Histonet] Re: New H&E stainer validation

[Bryan Szpunar]

Hi Albert,
I would think of this more in terms of "performance verification" than
validation, where the instrument is concerned. You verify that the
instrument is working and you also validate the staining protocols you run
on it. Performance verification can include several different things, such
as electrical checks, having training documentation in place, and any
installation qualification done by the installer/vendor/etc. For an
automated stainer, running several test slides to ensure the mechanisms are
operating correctly would also be appropriate. And of course, document,
document, document.
Basically, you should perform some kind of documented verification that the
instrument performs properly and as expected, then address the specific
staining protocols as a second "piece" of the puzzle (although you likely
will perform both functions concurrently). For an H&E, I would usually want
to see a minimum of 20 samples stained, reflecting a good mix of the types
of samples you expect to see--guessing in your case mostly Derm stuff.
Specifics for the validation, though, are mostly the purview of your
medical director.

Your question was fairly general, so hopefully I've focused on things that
are helpful to you.

Regards,
Bryan Szpunar, HT(ASCP)CM