[Histonet] QC/Validation of Histo Chemicals
Morken, Tim - Labvision
tpmorken <@t> labvision.com
Wed Sep 24 10:28:51 CDT 2003
Barbara,
I've never heard of anything like that in histology. Every inspection I've
been involved in has been more interested in freshness of chemicals, date of
production, documentation of who made it up, written procedures for
producing the reagents, etc. The controls run during a procedure are
supposed to "validate" whether the procedure actually works - which
validates whether the chemicals "work."
I guess that you would need to run a procedure on a control and replace only
the given chemical, leaving all others the same. If you make up all new
reagents for a procedure then you would need to do the same for every other
chemical in the procedure. So for a stain that requires 10 chemicals, you
would need to do ten different control runs, each with only one chemical as
the variable. Sound like a lot of work for little or no real value - after
all, most of these reagents are very simple solutions that "work" all the
time.
Tim Morken
Lab Vision / NeoMarkers
www.labvision.com
-----Original Message-----
From: Barbara Stancel [mailto:stancelb <@t> msn.com]
Sent: Wednesday, September 24, 2003 4:55 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] QC/Validation of Histo Chemicals
To all histology laboratories inspected by any agency:
Are you required to validate (do they work?) chemicals such as: 1% acetic
acid, acid alcohol, dilutions of hydroquinone, Scott's Tap Water, 10% NBF,
Bouin's, aqueous solutions of sodium thiosulfate, periodic acid, sodium
borate, picric acid solutions, etc. (get my drift?)? Do your auditors
consider the QC you do for stains and dyes as a satisfactory
confirmation/validation that an individual solutions within a procedure
work?
I am not talking about QC of stains. In this lab that is a given...after
preparation, all stains and dyes are QC'ed and the slide is labeled and kept
as a permenent record. Auditors are wanting us to mark chemicals with a big
ole "needs approval" label. After we prove they work, we apply a big ole
"validate" label on all the bottles. We already have a labels on the
bottles. Each contains the batch number, solution, stain, date, QC date and
the person who performed the QC. The batch number is tracable on a special
sheet on which we record even more information...like all the inventory
numbers for the chemcials, stains or dyes used in the preparation of that
solution, date prepared, date in use, date out of use, etc.
Since all our auditors are chemist or microbiologist we are trying to make
them see our point of view. This needs approval/validation method is used
in chemistry and microbiology.
Any suggestions? (please tell me which agency audits your lab)
Histologically yours,
Barbara (who feels like I am recording my life on spreadsheets with batch
and inventory numbers!)
Barbara H. Stancel, HTL(ASCP)HT
USDA, FSIS, OPHS, Eastern Laboratory, Pathology
RRC, 950 College Station Road
Athens, Georgia 30604
phone: (706) 546-3556
fax: (706) 546-3589
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