[Histonet] Validating a new manual special stain

[Beth Cox]

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"
>
> 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
>
>
> ------------------------------
>
> Subject: Digest Footer
>
> _______________________________________________
> Histonet mailing list
> Histonet at lists.utsouthwestern.edu
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet
>
> ------------------------------
>
> End of Histonet Digest, Vol 204, Issue 4
> ****************************************