[Histonet] QC/Validation of Histo Chemicals
Barbara Stancel
stancelb <@t> msn.com
Wed Sep 24 06:54:47 CDT 2003
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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