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From:"Jennings-Siena, Debbie" <> (by way of histonet)
To:histonet <>
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

> -----Original Message-----
> From:	Janice Mahoney []
> Sent:	Wednesday, March 31, 1999 5:10 PM
> To:
> Subject:	IHC
> >Date: Wed, 31 Mar 1999 15:45:04 -0600
> >To: histo net
> >From: Janice Mahoney <>
> >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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