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Bruce H. Davis,MD
Wm Beaumont Hosp.
---------- Forwarded message ----------
Date: 24 Oct 1995 14:51:46 -0800
From: Joanne Cornbleet <joanne_cornbleet@clinlabs.stanford.edu>
To: cyto-inbox
Subject: FW: FW: CLIA rules on antibody expiration dates (fwd)
_______________________________________________________________________________
From: Albert_Rabinovitch@BDHQ.BD.COM on Tue, Oct 24, 1995 2:30 PM
Subject: Re: FW: CLIA rules on antibody expiration dates (fwd)
To: cyto-inbox
Dear Joanne,
Up until recently, the feds were adamant about the mindless "it's OK at 11:59
pm
on Jan 3rd, but no good at 12:01 am on Jan 4th". However, we initiated a test
challenge with Checklist 5, where my strategy and that of the TMRC was to pit
the FDA against HCFA, which worked as shown in the HCFA-approved exception
described in the NOTE to the Question:
QUESTION: 05:3125 PHASE: II
Are all reagents used within their indicated expiration date?
NOTE: Rare reagents (e.g., anti-Jka, anti-Lea, etc.) may be used beyond their
expiration date if appropriate positive and negative controls are run and react
as expected. This exception is permitted by FDA and AABB. This does NOT apply
to reagents that are readily available.
Soooo, the next move is up to us (the CAP) in terms of where else we might like
to focus a challenge to the Federal Register without bringing down the entire
house. Frankly, a better strategy is to get HCFA to change the Fed Reg rules
so
we don't have to wage single fights with each Checklist, and the imprecision of
regulators' review. Would you like to lead the charge?
Rab
______________________________ Reply Separator
_________________________________
Subject: FW: CLIA rules on antibody expiration dates (fwd)
Author: "Joanne Cornbleet" <joanne_cornbleet@clinlabs.stanford.edu> at
SMTP_MAIL
Date: 10/24/95 2:42 PM
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From: Bruce Davis, MD - Clinical Pathology on Tue, Oct 24, 1995 7:29 AM
Subject: RE: CLIA rules on antibody expiration dates (fwd)
To: cyto-inbox
Can laboratories establish inhouse methods of verifying antibody stability
and continue to use after expiration date? I think this is sticking point
and an area that inspectors, as well as laboratories, need clarification.
If you do not have an "official" CAP interpretation, I will call Becky
Johnson for her thoughts.
Thanks, BHD
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