[Histonet] Powdered reagent expiration dates

Pat Laurie foreightl <@t> gmail.com
Tue Jul 27 11:00:20 CDT 2010


Thanks for your help, based off your explanations, statements and citations,
we will attempt to protest this and have it expunged.

On Mon, Jul 26, 2010 at 4:41 PM, Lee & Peggy Wenk <lpwenk <@t> sbcglobal.net>wrote:

> See if you can get the following article. Biotech Histochem is published by
> the Biological Stain Commission. http://www.biologicalstaincommission.org/
> Biotech Histochem. 2009 Feb;84(1):11-5.
> Stain and dye stability over a 30-year period: a comparison of certified
> dye
> powders by the Biological Stain Commission.
> Penney DP, Frank M, Fagan C, Willis C.
> Biological Stain Commission, Department of Pathology & Laboratory Medicine,
> University of Rochester Medical Center, Rochester, New York 14642-0001,
> USA.
> David_Penney <@t> urmc.rochester.edu
> Abstract
> The Biological Stain Commission (BSC) Assay Laboratory has received
> numerous
> inquiries during the past several years regarding the long-term stability
> of
> stain and dye powders, particularly since packaging requirements call for
> expiration dates on reagents. We have conducted a study to examine the
> long-term stability of selected dye powders. We used the standard
> procedures
> of the BSC for testing biological stains for certification to give an
> indication of the long-term chemical stability as well as staining
> performance of the dye powders. An earlier study by Emmel and Stotz
> examined
> the stability of various dye powders after a five-year storage period. The
> present study is a follow-up project covering the same dyes after storage
> for 30 years. The dye samples chosen for the study are the same samples
> used
> in the five-year storage period study and give comparative results for all
> three time periods. The results of this study affirm the generally held
> speculation that dye powders are stable for many years and thus have a
> substantial shelf-life.
> Peggy A. Wenk, HTL(ASCP)SLS
> 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 Pat Laurie
> Sent: Monday, July 26, 2010 1:27 PM
> To: Histonet <@t> lists.utsouthwestern.edu
> Subject: [Histonet] Powdered reagent expiration dates
>  We were inspected by CAP on friday and we were cited for
> ANP.21366  *Are reagents and solutions properly labeled, as applicable and
> appropriate, with the following elements?*
> * *
> 1.      *Content and quantity, concentration or titer*
> 2.      *Storage requirements*
> 3.      *Date prepared or reconstituted by laboratory*
> 4.      *Expiration date*
> Specifically that our staining powders didn't have an expiration date
> printed on the bottle. All of our reconsituted reagents which are in use
> were dated with an expiration date properly though. I have always assumed,
> perhaphs incorrectly, that powdered stains never expire.  We have powders
> like Luxol Echt Blau, etc. that were purchased and opened over 40
> years ago.    If so, then these powdered reagents have gone through CAP
> inspections since the beginning and this inspector was the first one to
> find
> this problem.  Is this one that we might protest?
> --
> Patrick Laurie HT(ASCP)QIHC
> CellNetix Pathology & Laboratories
> 1124 Columbia Street, Suite 200
> Seattle, WA 98104
> PH: 206-215-5949
> plaurie <@t> cellnetix.com
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Patrick Laurie HT(ASCP)QIHC
CellNetix Pathology & Laboratories
1124 Columbia Street, Suite 200
Seattle, WA 98104
PH: 206-215-5949
plaurie <@t> cellnetix.com

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