[Histonet] Validating a new manual special stain
Beth Cox
bethcoxx at gmail.com
Sat Nov 7 13:30:34 CST 2020
The new CAP Checklist (published 6/4/2020) no longer requires
validations for "/LDTs that employ the following methods: manual
microscopy eg. histopathologic and cytopathologic microscopic
interpretation/" (see COM.40350, note 8). So, CAP does not require it
and won't have guidance for that. HOWEVER, CLIA still requires
validations! The common way to do that is to run a minimum of 5, and
preferably 10, different samples by the new method and grade them
according to expected results. A few of the samples should be
'negative' samples. Using various control tissue for your validations
is perfectly acceptable. Write that up, have the medical director
review the slides and sign and date the bottom of the form: "This
procedure has been validated and is approved for patient use."
Beth Cox, HTL/SCT(ASCP)QIHC
Pathology Solutions
Prescott, MI
----------------------------------------------------------------------
> Message: 1
> Date: Fri, 6 Nov 2020 18:35:25 +0000
> From: "Pairan, Kelly" <Kelly.Pairan at nationwidechildrens.org>
> To: "'histonet at lists.utsouthwestern.edu'"
> <histonet at lists.utsouthwestern.edu>
> Subject: [Histonet] Validating a new manual special stain
> Message-ID:
> <49e4f7123d03401385e3727519640c63 at l1perdwmbx04.childrensroot.net>
> Content-Type: text/plain; charset="us-ascii"
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> Good Afternoon,
> We are currently updating one of our manual special stain procedures. How have you documented the validating of a new special stain method at your institution? We have a IHC validation protocol that follows the CAP guidelines but the CAP checklist does not mention special stain validations.
>
> Thanks for your input,
> Kelly
>
>
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