Good morning to y'all
Last year, we had a CLIA inspection a couple of months after our CAP
inspection. On an oversight, the CLIA inspector found  an expired
alpha-1-antitrypsin bottle in the refrigerator. She wanted to see
documentation that the antibody was still good.  I told her that we run a
known positive control with every run and at the time the controls are QCed,
we revalidate that the reagent is viable.  Well, since I did not have the
documentation or a written procedure atesting to this, it was a write up.
So, I developed a procedure to revalidate all reagents and keep a log.
    By the way, the CLIA inspector found alot of other discrepancies
throughout the rest of the lab.  The lab manager was let go and some section
supervisors were reprimanded.  I felt lucky that I escaped with only a
simple write up.  I now work in a private lab, but the lessons I learned
from that one CLIA inspection will always follow me.  I've been throuogh
many CAP, military, governmental and JCAHO inspections, but nothing compares
to a CLIA inspection

Joe Nocito, BS, HT (ASCP) QIHC
Histology Manager
Pathology Reference Lab
San Antonio, Texas
----- Original Message -----
From: "Morken, Tim" 
To: 
Sent: Friday, February 01, 2002 5:19 AM
Subject: RE: Use of outdated antibodies


> Peggy wrote;
> < beyond the manufacturer's recommended expiration dates. But you have to
test
> and document that the antibodies are still good. On a routine basis.>>
>
>
> Yes, all you have to do is document successful use of the antibody. This
is
> why databases are so useful in immunochemistry. Our database holds all IHC
> experiment info and the dates of each experiement. The antibody database
is
> linked to the experiment database and each antibody has a list of all
> positive cases run. So, the antibody information page from the database
can
> be printed out and shows all antibody info, protocols for use, lot numbers
> and lot use info and every positive stain. It is very easy to show that
the
> antibody has been working adequately over a given period of time.
>
> Tim Morken
> CDC, Atlanta
>
>
>
> -----Original Message-----
> From: Lee & Peggy Wenk [mailto:lpwenk@mail.netquest.com]
> Sent: Thursday, January 31, 2002 7:47 PM
> To: Smith, Sherry A. (Histology); histonet@pathology.swmed.edu
> Subject: Re: Use of outdated antibodies
>
>
> This is from the CAP checklist for IHC:
>
> ANP.22450 Phase II
>
> Are storage conditions of immunoreagents optimal for maintaining expected
> shelf life?
>
> COMMENTARY:
>
> The storage conditions of the immunoreagents in use must be improved to
> maintain their expected shelf life.
>
> REFERENCES: 1) Tubbs RR, et al. Extension of useful reagent shelf life
> beyond manufacturers' recommendations. Arch Pathol Lab Med.
> 1998;122:1051-1052; 2) Balaton AJ. Satisfactory performance of primary
> antibodies beyond manufacturer's recommended expiration dates. Appl
> Immunohisto Mol Pathol. 1999;7:221-225.
>
>
>
> So, if I remember the articles correctly: yes, antibodies could to be used
> beyond the manufacturer's recommended expiration dates. But you have to
test
> and
>  document that the antibodies are still good. On a routine basis.
>
> Hope these were what you were looking for.
>
> Peggy A. Wenk, HTL(ASCP)SLS
> William Beaumont Hospital
> Royal Oak, MI 48073
>
>
> ----- Original Message -----
> From: "Smith, Sherry A. (Histology)" 
> To: 
> Sent: Thursday, January 31, 2002 8:43 AM
> Subject: Use of outdated antibodies
>
>
> > Dear Histotechs.,
> >
> > Are there any known articles about the use of outdated antibodies??  I
> > remember reading one article but can't seem to locate it now.  Any info.
> > would be greatly appreciated.
> >
> > Thanks,
> > Sherry Smith
> > Presbyterian Hospital
> >
> >
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>
>