[Histonet] QC/Validation of Histo Chemicals

[Barbara Stancel]

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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