[Histonet] CAP QUESTION ANP.12425 ASR disclaimer on pathology reports

[Morken, Tim]

The disclaimer is only for ASR antibodies. They don't have to be labeled "experimental" because a CLIA certified lab has full capability and authority to validate any antibody they want to use for any purpose. You do have to document your validation procedure and results.

You can also use RUO antibodies under CLIA regs as long as you do the full documented validation. Interestingly there is no suggested disclaimer for RUO antibodies. 

Tim Morken
Supervisor, Histology / IPOX
UCSF Medical Center
San Francisco, CA  
 

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Foshey, Annette
Sent: Friday, November 20, 2009 9:55 AM
To: (histonet <@t> lists.utsouthwestern.edu)
Subject: [Histonet] CAP QUESTION ANP.12425 ASR disclaimer on pathology reports

What is the current practice for meeting this regulation?  Is a general statement (disclaimer) placed on all pathology reports that have immunocytochemistry and/or
FISH and ISH or is the disclaimer placed only on the reports where the class 1 ASR antibody or nucleic acid have been used?

Thanks for your input?
Annette Foshey
Charge Tech in Histology
Children's Hospital of Wisconsin
414-266-6580        Fax 414-266-2779
afoshey <@t> chw.org


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