RE: [Histonet] QC/Validation of Histo Chemicals

From:"Morken, Tim - Labvision"

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

Tim Morken
Lab Vision / NeoMarkers

-----Original Message-----
From: Barbara Stancel [] 
Sent: Wednesday, September 24, 2003 4:55 AM
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 

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 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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