RE: CAP INSPECTION
I assume we are talking about IHC antibodies?? If so the FDA "clearly
distinguishes ASRs from Immunohistochemistry (IHC) reagents (final rule
effective August 17, 1998)." "Unlike ASRs, IHCs are labeled by
manufacturers with directions for use and performance indications."
This issue has been repeatedly addressed in my laboratory. The above is
quoted from CAP Advocacy - CAP Talking Points which is dated December
1998. If IHCs are what is in question, it would appear that ASRs do not
need to be addressed by your laboratory. Hope this helps.
Boyce and Bynum Pathology Laboratories
Columbia, Missouri 65202
From: Cindy/Rick DuBois [mailto:email@example.com]
Sent: Tuesday, March 18, 2003 10:48 AM
Subject: CAP INSPECTION
We recently were CAP inspected and got written up for not having a ASR
list. This is supposedly a list of all FDA approved Antibodies. Does
anyone have such a list?
Delta Pathology Assoc.
Stockton, CA 95207
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