[Histonet] FW: ASRs
Horn, Hazel V
HornHV <@t> archildrens.org
Tue Jan 27 13:42:39 CST 2004
The disclaimer is necessary if the antibody is labeled ASR by the
manufacturer. If it is, you must use the disclaimer. Almost all of our
antibodies are IVD or ASR and we bill for those. But, if we have a RUO
antibody (we have 2) we do not bill for those immunos. It's not a CAP
requirement, it's a CLIA requirement for the statement and CAP is just
following through with their inspections to see if labs are complying.
Hazel Horn, HT/HTL (ASCP)
Histology Supervisor
Arkansas Children's Hospital
Phone - 501.364.4240
Fax - 501.364.3912
-----Original Message-----
From: Mitchell, Jeannette M. [mailto:Jeannette.Mitchell <@t> vtmednet.org]
Sent: Tuesday, January 27, 2004 1:05 PM
To: Histonet <@t> pathology.swmed.edu
Subject: [Histonet] FW: ASRs
> Can folks tell me what they are doing with regard to CAP Checklist
> Dec. 2003 question # ANP.12425 regarding ASRs (Analyte Specific
> Reagents) ? We currently do not have any disclaimer in our patient
> surgical reports because all our antibodies are commercially produced
> (not "home brews"). In reading this recently revised requirement
> however it sounds like we need to have this statement in all our
> reports that have had IHC performed. Most of the antibodies we use
> have package inserts saying for "Research Use Only".
>
> I'd appreciate any feedback as to whether the CAP recommended
> disclaimer is necessary with commercially bought antibodies (not in
> kits). thanks Jude
> Jude Carpenter, BS, HTL(ASCP)
> Chief Technologist for Autopsy/Histology/Surgical Pathology
> 111 Colchester Ave.
> Burlington, VT 05401
> jude.carpenter <@t> vtmednet.org
> (802)847-5116
> fax: (802)847-3509
>
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