[Histonet] stain shelf life

Shea's jshea121 <@t> roadrunner.com
Wed Dec 14 14:01:07 CST 2011


Ditto, to the previous messages .... my best stain powders are from the early 1900's.



For those  CAP accredited lab, this is what CAP has to say about stains w/o expiration dates (below)



What I have done to comply is, I have a policy that states that I evaluate reagents at least annually and document acceptable performance (this is in our special stain log book in the column for quality/acceptable staining of of positive control).

Then, I printed stickers  "date evaluated/stain/ initials _________ _______ ________

                                                                                        _________ _______ ________

I place sticker on bottle and fill in the info only once/yr. (It is very likely that I use the stain or chemical several times per yr for different staining procedures, but I only fill in the evaluation sticker once/yr -( I know they still work well, It is just documentation to comply w/ CAP).





**REVISED** 07/11/2011

ANP.21382 Reagent Expiration Date Phase II

All reagents are used within their indicated expiration dates.

NOTE: This checklist requirement applies to all reagents used in the laboratory (histochemical,

immunohistochemical, and immunofluorescent reagents, and reagents used for molecular tests).

The acceptable performance of histochemical stains is determined by technical assessment on

actual case material, use of suitable control sections, and as part of the pathologist's diagnostic

evaluation of a surgical pathology or autopsy pathology case.

Some histochemical stains used in the histology laboratory are not subject to outdating, so that

assignment of expiration dates may have no meaning. The acceptable performance of such stains

should be confirmed at least annually by technical assessment, as described above. (If the

manufacturer assigns an expiration date, it must be observed.).

For laboratories not subject to US regulations, expired reagents may be used only under the following

circumstances: 1.The reagents are unique, rare or difficult to obtain; or 2. Delivery of new shipments

of reagents is delayed through causes not under control of the laboratory. The laboratory must

document validation of the performance of expired reagents in accordance with written laboratory

policy. Laboratories subject to US regulations must not use expired reagents.

Evidence of Compliance:

? Written policy for evaluating reagents lacking manufacturer's expiration date


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