Linda A. Sebree, HT(ASCP)
University of Wisconsin Hospital & Clinics
IHC/ISH Laboratory
A4/204-2472
600 Highland Ave.
Madison, WI 53792-2472
(608)265-6596
FAX: (608)262-7174


-----Original Message-----
From: Morken, Tim [mailto:tim9@cdc.gov]
Sent: Thursday, April 05, 2001 9:39 AM
To: 'Sebree Linda A.'
Subject: RE: Revalidating immuno reagents


Linda, 
I used to do this sort of thing to satisfy CAP. The difference was that as
the expiration date for a particular antibody came up we would document
specifically that that antibody worked at that time and then we would set a
new expiration date of 6 months to one year, depending on what you are
comfortable with. That satisfied them in the last CAP inspection I went
through in 1997. CLIA is a bit different, and we are different here at CDC,
where most of our antibodies are made in-house, and have no a official
expiration dates.

Tim

BTW, post this to histonet if you want. I think others would be interested
in commenting.

-----Original Message-----
From: Sebree Linda A. [mailto:la.sebree@hosp.wisc.edu]
Sent: Thursday, April 05, 2001 10:32 AM
To: 'Morken, Tim'
Subject: RE: Revalidating immuno reagents


Tim,

Do you think this type of documentation would satisfy CAP?  Their policy is
sort of "don't ask, don't tell" but even so our inhouse QA/QC people enforce
CAP regulations by the book so they've never let us use expired reagents.

Linda A. Sebree, HT(ASCP)
University of Wisconsin Hospital & Clinics
IHC/ISH Laboratory
A4/204-2472
600 Highland Ave.
Madison, WI 53792-2472
(608)265-6596
FAX: (608)262-7174


-----Original Message-----
From: Morken, Tim [mailto:tim9@cdc.gov]
Sent: Thursday, April 05, 2001 8:36 AM
To: 'Histonet'
Subject: RE: Revalidating immuno reagents


Joe, CLIA was satisfied with our records showing previous uses of
antibodies. I developed a database that keeps track of all experiments and
can collate all uses of any antibody into an "antibody information sheet."
This sheet shows all information about a particular antibody, including all
previous uses of that antibody, slide by slide, and the results of those
uses, including comments about performance.

Tim Morken, BA, EMT(MSA), HTL(ASCP)
Infectious Disease Pathology Activity
Centers for Disease Control and Prevention
Ms-G32
1600 Clifton Road
Atlanta, GA 30333
USA

PH: 404-639-3964
FAX: 404-639-3043

email: tim9@cdc.gov



-----Original Message-----
From: Nocito, Joseph [mailto:joseph_nocito@srhc.iwhs.org]
Sent: Thursday, April 05, 2001 8:38 AM
To: 'Histonet'
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