Re: Immuno procedure for method performance specifications

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From:Tim Morken <> (by way of histonet)
To:histonet <>
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Since the method is qualitative, all you can do is provide proof that
your controls are good. This can be done by "certifying" your controls
in-house (and, if possible, by a reference lab - which could be the next
hospital or lab down the road). Keep records of control verification,
use, performance and reliability. This can all be written in a
procedure. Part of that should tell what to do when a control does not

Tim Morken, B.A., EMT(MSA), HTL(ASCP)
Infectious Disease Pathology
Centers for Disease Control
1600 Clifton Rd.
Atlanta, GA 30333


FAX:  (404)639-3043

----Original Message Follows----
Date: Tue, 02 Mar 1999 14:11:19 -0500
Subject: Immuno procedure for method performance specifications

During our CAP inspection the inspector recommended we develop a
procedure for
method performance specifications for Anatomic pathology especially in
Immunohistochemistry. We argued that our immuno's were all interpretive.
anyone else been sited for this in AP or have a procedure for
Immunohistochemistry already?

CAP Question was Lab General 1.4202, 1.4203, 1.4208, 1.4210, 1.4210,

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