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 +
From: "Pairan, Kelly"
To: "'histonet@lists.utsouthwestern.edu'"
Subject: [Histonet] Validating a new manual special stain
Message-ID:
<49e4f7123d03401385e3727519640...@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
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