[Histonet] Expired antibodies...for immunos..

[Lee & Peggy Wenk]

JCAHO, CAP, etc. all refer labs back to the CMS (Center for Medicare and
Medicaid Services) and HHS (Health and Human Services), which go back to the
Federal government regulations, as laid out in 42CFR 493 (Code of Federal
Regulations - Laboratory Requirements):

Specifically, 42CFR 493.1252(d)
(1252 = Standard on Tests systems, Equipment, Instruments, Reagents,
Materials, and Supplies)

(d) = "Reagents, solutions, culture media, control materials, calibration
materials, and other supplies must not be used when they have exceeded their
expiration date, have deteriorated, or are of substandard quality."

http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr493_04.html

(Hope the link works.)

Sorry, there's no exception for costly IHC or ISH solutions that cost a lot
of money and that we know we can "prove" are still good.

The only thing I can see us histotechs doing is persuading the manufacturers
to sell the reagents in smaller quantities. (Which they already have, over
the years.)

Peggy A. Wenk, HTL(ASCP)SLS
William Beaumont Hospital
Royal Oak, MI 48073



-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
KMB1904 <@t> aol.com
Sent: Thursday, April 27, 2006 3:24 PM
To: histonet <@t> pathology.swmed.edu
Subject: [Histonet] Expired antibodies...for immunos..

How does JCAHO handle expired antibodies if you have them...and are using
them...
  Is it ok ....or not??
   Kat
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