[Histonet] RE: Validation

[Morken, Timothy]

Kim wrote: "Seems the actual amount of validation slides can vary with different Medical directors( Pathologist)"

Yes, validation is simply the process of proving to yourself and anyone else (pathologist, clinician, inspector,  patient, lawyer) that the product works as intended. Medical Directors are responsible for determining what that entails, whether large or small sets of tissue. There are certain recommendations that have been written up but it all comes down to being able to convince anyone who looks into it that everything is well done.

CLIA regulations outline the process and following it will ensure you are on the right track.

I have some documents up on a Yahoo groups page that anyone can download. They are from a validation presentation at NSH and ASCP meetings, including the presentation powerpoint outling CLIA and CAP requirements, model validation procedure and model validation documentation forms. You have to join the group but it is free and I promis there will be no emailings to bug you.

Go to Yahool groups and search for "Histoinfo" group

Tim Morken
Supervisor, Histology, IPOX
UCSF Medical Center
San Francisco, CA, USA
________________________________
From: Kim Donadio [mailto:one_angel_secret <@t> yahoo.com]
Sent: Wednesday, November 16, 2011 12:42 PM
To: Morken, Timothy; 'Amber McKenzie'; histonet <@t> lists.utsouthwestern.edu
Subject: Re: [Histonet] RE: Validation

Seems the actual amount of validation slides can vary with different Medical directors( Pathologist) or thats what Ive seen in places. They( The Pathologist) sign off on it. With that said ER/PR and Her2 have more vigorous criteria( very specific, such as the 25-50). Also, the 2011 AP133 guidline is suppose to go into more detail on this. I havnt seen that new recomendation yet. So If anyone has it, would love to see it posted here myself?

Thanks

Kim

From: "Morken, Timothy" <Timothy.Morken <@t> ucsfmedctr.org>
To: 'Amber McKenzie' <amber.mckenzie <@t> gastrodocs.net>; "histonet <@t> lists.utsouthwestern.edu" <histonet <@t> lists.utsouthwestern.edu>
Sent: Wednesday, November 16, 2011 2:08 PM
Subject: [Histonet] RE: Validation

Amber, is this new instrument the same kind as your old instrument and are you using the same reagents? Or is it a totally different platform with different reagents?

Putting in a new instrument of the same kind and using the same reagents just requires verifying the new instrument works. You have to convince whoever wants to know that it works the same as the older instrument so running a variety of antibodies and procedures on it will suffice to prove that. Doing reproducibility tests also proves the instrument works as intended - 5 to 10 identical slides on one run, 5 to 10 identical slides on 5 to 10 runs.

If it is a totally different platform with different reagents then you are in for revalidating each of your antibodies on the new system.

Tim Morken
Supervisor, Histology, IPOX
UCSF Medical Center
San Francisco, CA, USA

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu<mailto:histonet-bounces <@t> lists.utsouthwestern.edu> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu<mailto:histonet-bounces <@t> lists.utsouthwestern.edu>] On Behalf Of Amber McKenzie
Sent: Wednesday, November 16, 2011 10:21 AM
To: histonet <@t> lists.utsouthwestern.edu<mailto:histonet <@t> lists.utsouthwestern.edu>
Subject: [Histonet] Validation


Just wondering what y'alls opinion is on validation:  I don't really understand why optimization isn't enough.  At that point, the pathologist has said what he wanted the stain to look like, so why do 3-10 positive slides on the new instrument to compare to previous slides from another instrument?  Thanks!

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