RE: IHC
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From: | "Jennings-Siena, Debbie" <ds.jennings-siena@baylordallas.edu> (by way of histonet) |
To: | histonet <histonet@magicnet.net> |
Reply-To: | |
Date: | Fri, 2 Apr 1999 03:09:30 -0500 |
Content-Type: | text/plain; charset="us-ascii" |
Hi Janice,
I have been checking into this also. According to what I have found out is
that if you are using antibodies classified as ASR's that you have to place
a disclaimer on the Surgical Pathology Report. FDA has specified the
language that must appear. CAP has gotten permission to add additional
verbage to the disclaimer which is optional, of course. I have contacted
all of the vendors that we purchase antibodies from and asked which ones are
ASR's and now that I have that all complied, I have forwarded it to our
Compliance Committee for review. I can get you copies of the wording if you
need it.
Debbie J. Siena, HT(ASCP)QIHC
Baylor University Medical Center
3500 Gaston Ave.
Dallas, Texas
214/820-2465 VM
214/820-4110 Fax
ds.jennings-siena@baylordallas.edu
> -----Original Message-----
> From: Janice Mahoney [SMTP:jmahone@nmhs.org]
> Sent: Wednesday, March 31, 1999 5:10 PM
> To: Histonet@pathology.swmed.edu
> Subject: IHC
>
> >Date: Wed, 31 Mar 1999 15:45:04 -0600
> >To: histo net
> >From: Janice Mahoney <jmahone@nmhs.org>
> >Subject: IHC
> >
> >Hello,
> >Has there been discussion here about the whole disclaimer ARS issue?
> >Can anyone put the whole issue into a nut shell for me. (Some of the
> literature we've seen and the info we're getting from vendors seems a bit
> contradictory.)
> >Is there anyone out there who likes reading Federal Registers?
> >Jan Mahoney
> >Omaha
>
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