We put a note on each 'expired' antibody that it 'requires re-validation'.
Then when we re-validate (run it again with the appropriate control slides)
we use our initial validation form, designate a re-validation and document
the results.  We keep these in a manual, filed under the antibody name with
the spec sheets and lot numbers, dates, etc.   I don't know if this would
help all inspectors but it may be worth a try.

Barb Davies
Memorial Hospital
Colorado Springs, CO



"Nocito, Joseph" <joseph_nocito@srhc.iwhs.org>


"Nocito, Joseph" <joseph_nocito@srhc.iwhs.org> on 04/05/2001 06:37:33 AM

To:   'Histonet' <histonet@pathology.swmed.edu>
cc:

Subject:  Revalidating immuno reagents


Good morning all,
     During the last two days, we have been inspected by CLIA. The
inspector found an expired immuno reagent in the refrigerator (I know,
shame
on me).  I explained to this person that although the reagent is expired, I
always run a known positive control with each run.  If the control didn't
work, the case is repeated with another lot number. This was not good
enough
for this person. She wanted proof.  Short of performing a short immuno run
in front of this person, I couldn't site any references.
     Does any one have a procedure that can be referenced dealing with
validaing and re-validating reagents?  I'll also mention that each primary
antibody gets titered upon receipt and each new detection kit gets tested
and the results recorded before it is put into use.
     Thanks in advance.

Joe Nocito, B.S., HT(ASCP)QIHC
Histology Supervisor
Christus Santa Rosa Hospitals
San Antonio, Texas