[Histonet] RE: Validation Sign off

[Willis, Donna G.]

Laure,
You also need to have a policy that states what areas the CLIA Director is allowing a designee to represent. 

Donna Willis, HT/HTL (ASCP)
Anatomic Pathology Manager
Baylor University Medical Center-Dallas
ph. 214-820-2465 office
ph. 214-725-6184 mobile
donna.willis <@t> baylorhealth.edu


-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Morken, Timothy
Sent: Wednesday, September 11, 2013 1:09 PM
To: Laurie Colbert; Histonet Post (histonet <@t> lists.utsouthwestern.edu)
Subject: [Histonet] RE: Validation Sign off

Laurie, it can be a designee, but that should be detailed in your validation procedure so it is clear the designee is acting for the Technical Director.


Tim Morken
Department of Pathology
UC San Francisco Medical Center



-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Laurie Colbert
Sent: Wednesday, September 11, 2013 10:46 AM
To: Histonet Post (histonet <@t> lists.utsouthwestern.edu)
Subject: [Histonet] Validation Sign off

When validating IHC antibodies and detection kits (either initially or with new lots), does a pathologist have to sign off on the validation , or can it be his/her designee (such as a PhD) that signs off?  The pathologist will be signing the IHC procedures.

Laurie Colbert, HT (ASCP)

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