[Histonet] IHC negative controls

[Sebree Linda A]

I really doesn't matter what I think of course Melissa.  When I presented the facts to the faculty they overwhelmingly agreed not to drop the negative controls and they were definitely not going to be in direct conflict with CLIA reg's.  It's really up to your lab's manager/director whether an extensive validation is adequate.  

Good luck with your decision,

Linda 

-----Original Message-----
From: Kuhnla, Melissa [mailto:Melissa.Kuhnla <@t> chsli.org] 
Sent: Monday, October 29, 2012 5:23 AM
To: Sebree Linda A; Glen Dawson; histonet
Subject: RE: [Histonet] IHC negative controls

Very good point Linda.  The only testing we currently report as an FDA approved test are our breast markers.  It may be easy enough to maintain the negative in that scenario.  For other scenarios, we are considering dropping the negative as long as we perform and document an extensive validation.  It still may be well worth it.  What do you think?

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Sebree Linda A
Sent: Friday, October 26, 2012 10:24 AM
To: 'Glen Dawson'; histonet
Subject: RE: [Histonet] IHC negative controls

Hey Glen,

Don't know the answer to your specific question but on a related issue, our lab has decided to maintain running negative controls due to the fact that the manufacturer's data sheets for our IHC detection kits and a majority of our antibodies require using +/- controls. The company in question has told us they do not intend to change their guidelines as its part of the FDA approval for their products. Performing IHC staining not in compliance with the manufacturers' guidelines is against CLIA reg's.  

Something to consider.

Linda

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Glen Dawson
Sent: Friday, October 26, 2012 8:45 AM
To: histonet
Subject: [Histonet] IHC negative controls


All,
 
Can anyone tell me if JHACO & CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection?
 
I assume that this is the case, but I'd like to be sure.
 
Thank-you in advance,
 
Glen Dawson  BS, HT(ASCP), QIHC
Histology Technical Specialist
Janesville, WI
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