Re: Antibody spec. sheets
We only keep one from each lot # we use. We also archive the ones that
we have used in the past. The reason for this is not a regulation but more
of a paranoia. There is no reason that a company can't decide at some point
that they want to change their spec sheet or change something in the
reagent. The companies are not going to inform you of every slight change of
wording on all their spec sheets. If you do not keep the spec sheets around
you may never know there has been a change. This would make it difficult to
explain any changes in staining that might occur due to a subtle change. The
idea is that as long as the slide is legally relevant the spec sheet is too.
Also, often a manufacturer stops making a particular clone. As a result
the lab would have to either switch clones or switch companies. If there is
an interest in an older case and someone wants to see a spec sheet for this
antibody the new one you use will not be much help. Yes, the OCD (obsessive
compulsive disorder) Man strikes again.
Paper trails to you ... until we're sued again ...
PS: Not that I've actually been sued it just fit in the lyrics (haha).
----- Original Message -----
From: "Cornett, Lorraine D"
Subject: Antibody spec. sheets
> Does anyone have any idea's on antibody spec. sheets.....We do immuno's in
> our lab, and we are tidying up for CAP inspection. I have found that we
> have EVERY spec sheet, for EVERY antibody ever used in our lab. They take
> considerable amount of space, and I was wondering if I have to keep ALL of
> them. I am in disagreement with my tech who is responsible for immuno's.
> She says we have to keep every one, forever. Does anyone know of a reg.
> this. Most of these are duplicates, same clone, same manufacturer, etc,
> Your responses will be appreciated..
> Lorraine Cornett HT (ASCP)
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