RE: Revalidating immuno reagents
|From:||"Hagerty, Marjorie A." <firstname.lastname@example.org>|
Maybe the problem is that you did not document that you extended the
expiration date. It's the 'ole if you don't document you took the
temperature, you didn't take the temp - even if you did.
Below is our policy. I have never been inspected by CLIA only CAP and the
State, and am a CAP inspector myself.
Marjorie Hagerty H.T. (ASCP) H.T.L., Q IHC
Supervisor, Anatomic Pathology
Eisenhower Medical Center
39-000 Bob Hope Drive
Rancho Mirage, CA 92270
(It is necessary to mark on the antibody itself that it is extended and to
In an effort to contain costs without compromising quality of performance,
the expiration dates may be extended on certain immunoreagents. These
reagents often perform with excellent results up to a year after the
expiration date. The reactivity will be monitored closely and use
discontinued if any change/difference in performance is observed. Expiration
dates will not be extended longer than three months at a time. (At three
months if the reagent is still performing optimally, the date is extended
another 3 months and the extension date is changed on the reagent and the
change recorded.) All immunohistochemical stains are checked/evaluated and
reactivity recorded each time a procedure is done. If a reagent with an
extended expiration date is not performing up to our usual standards, the
reagent(s) will be discarded and replaced immediately. Any procedure done
with substandard reagents will be repeated and corrective actions recorded.
Any reagent used beyond the expiration date will be marked with the extended
date and recorded on the, "IMMUNOREAGENTS EXTENDED EXPIRATION" worksheet.
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