Re: CLIA rules on antibody expiration dates

Bruce Davis, MD - Clinical Pathology (bdavis@beaumont.edu)
Tue, 24 Oct 1995 10:28:05 -0400 (EDT)

Greetings clinical flow types. For my two cents I would concur with
Wayne's thoughts. However, the question gets to the issue of
interpretation of the CAP checklist (shades of Marc Langweiler's previous
messages). I am trying to get an "official" CAP response to the question
and will broadcast when available. I do know that the CAP tried to resist
the current question reading, but was forced to accept it as part of
obtaining deemed status from CLIA.

Bruce H. Davis, M.D.
Wm Beaumont Hospital.

On Mon, 23 Oct 1995, Wayne Green wrote:

> We had a similar dilema which was resolved at the state level in Tennessee. In
> discussions with the state we were told that if we could document that these
> "expensive reagents" were still funtioning properly we could use them beyond the
> expiration date. Several labs across the state helped gather data for
> presentation to the state board showing that the initial qc of the reagents,
> with respect to per cent positives and fluorescent intensity, remained unaltered
> bewond the expiration date. The state then allowed an exception which permitted
> continued use of expired reagents IF you had the qc data in your lab to
> demonstrate that the bottle of expired reagent was still performing as it had
> when first received. A similar approach may work for your situation; after all
> the goal is to make sure accurate results are being reported and if you show the
> reagent is working properly the results should be correct (al other things being
> equal).
> I left Tennessee in the summer of 1994 and don't know the current
> success of this system. If you want an update check with Jim Price at the
> VA/Vanderbilt Flow Lab (615 327-4751 ext. 5859) or Keith Shults at Cytometry
> Associates in Brentwood, TN (615 370-8393). Good luck!
>
> --
>
> Wayne Green
> wgreen@genetics.utah.edu


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