Re: Here I go again[Histonet] Expiration date

From:Patti Loykasek

Joe - I totally agree with you. My only question is this: with the new CAP
rule in place, have you been cited for using expired reagents? While I would
be most concerned with proper QC, I know most inspectors go by the letter of
the rule, and aren't open for debate. We got written up for having a box
with an expired date on it - we were using it to store some excess
non-expired reagent ( I know, exactly a smart thing to do).

Patti Loykasek
PhenoPath Laboratories
Seattle, WA 



> Okay,
> I've been too quiet for too long. Here I go again.
> 
> I am so tired of CAP and their ridiculous regulations. Every CAP inspection
> I fight this same question. When I was supervising the Immuno lab at AFIP,
> we froze concentrated antibodies at -70 for years. Antibodies that were
> frozen in 1080, were still viable in 1990. That means we were running
> immunos in 1990 with 1980 prices. What is so wrong about that?
>   We also ran a known positive control with each batch. If the positive
> control worked, guess what? The antibody was still good. If the positive
> control did not work, we threw out that lot number and repeated it with
> another lot number. When we saw that there was a drop in the staining
> intensity, we  tossed that lot and started another. My experience with
> antibodies is that they just don't go bad over night, they start staining
> with less intensity.
>   I think that the CAP board members have stocks in the biochemical
> companies. Please don't get me wrong, I have many close friends that work in
> the biochemical side of this, but why would this drastic change in view? The
> FDA? I doubt it.
>   Maybe I'm too one sides on this issue, but give me a break! If the
> positive control works in any other antibody, doesn't that mean the antibody
> is viable?
>   I know companies have to put an expiration date on their products, but
> come on. If an antibody expires June 30, 2005, does it automatically go dead
> on July 1?
>   As managers and supervisors, we are continuously bashed about saving
> money. This would be a great place to start, don't you think?
>   That is all. Thank you
> 
> Joe Nocito BS, HT(ASCP)QIHC
> Histology Manager
> Pathology Reference Lab
> San Antonio, TX
> ----- Original Message -----
> From: "Katia Cristina Catunda" 
> To: "histonet" 
> Sent: Wednesday, June 15, 2005 8:20 PM
> Subject: [Histonet] Expiration date
> 
> 
>> What should we do with antibodies and reagents after their indicated
>> expiration dates? Theorectically they shouldn't be estable after the
>> expiration date but we do know that most of them still works perfectly...
>> should we just throw them out and not use them anymore, wouldn't this be a
>> way for the manufacturers manipulate their sellings? Need some opinions...
>> 
>> Tks
>> 
>> Katia
>> 
>> 
>> 
>> 
>> 
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> 
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