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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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 _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet The information in this e-mail, and any attachments therein, is confidential and for use by the intended addressee only. If this message is received by you in error please do not disseminate or read further. Please reply to the sender that you have received the message in error, then delete the message. Although Catholic Health Services of Long Island attempts to sweep e-mail and attachments for viruses, it does not guarantee that either are virus-free and accepts no liability for any damage sustained as a result of viruses. Thank you. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet