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

[Weems, Joyce]

(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."

I'm wondering if this phrase could be interpreted to be ONE of the three reasons listed because the conjunction is OR. This could be proven and documented by reasons given earlier.

Joyce


Joyce Weems
Pathology Manager
Saint Joseph's Hospital of Atlanta
404-851-7376
404-851-7831 - fax

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu]On Behalf Of Jan Shivers
Sent: Friday, April 28, 2006 10:40 AM
To: histonet
Subject: Re: [Histonet] Expired antibodies...for immunos..

And let us not forget that it's the antibody manufacturers who set these
expiration dates.  Is there an actual science behind determining an
antibody's 'lifespan', or is it more of a business profit decision?  It's
certainly cost-inefficient for a lab to pay upwards of $500 for an antibody
which you only use a few times before its expiration date hits, yet the
doctors/clients want these tests available.

If we can't change the wording on the rules and regulations in regards to
using antibodies past their expiration date, despite proof of their
continued reactivity... then we should encourage the manufacturers to set
more reasonable expiration dates.... or sell in smaller quantities, as Peggy
stated below.

Jan Shivers


----- Original Message -----
From: "Lee & Peggy Wenk" <lpwenk <@t> sbcglobal.net>
To: <KMB1904 <@t> aol.com>; <histonet <@t> pathology.swmed.edu>
Sent: Friday, April 28, 2006 4:48 AM
Subject: RE: [Histonet] Expired antibodies...for immunos..


> 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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>
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