[Histonet] GLP question

[Trajkovic, Dusko]

If our lab had the same operation as Jackie O., then that is the way I
would also perform the GLP tracking. However, our set up is similar to
Kim Merriam, where each Histotech is responsible for their own study or
work assigned. One person will do the trimming, embedding, sectioning,
staining and self QC. I don't consider my slides as final product until
I sign off on the QC portion, have someone else verify and initial  that
my numbers are correct (blocks and slides match and are all accounted
for) then hand the slides to the pathologist. 

During my QC process, if I find that there are imperfections in the
sections (this is hypothetical, since things like that never happen to
me) such as folds, knife marks, floaters, etc. I go back to recut the
slide, restain and QC again. If I am satisfied with my new freshly
coverslipped slide, I sign off the animal and submit my slides. The
slide that I discarded is nothing more than any other section that I
discarded during my microtome sectioning before deciding that I am deep
enough in the block and it's time to collect my ribbon and place on the
water bath.

This is my story, and my opinion on the GLP process. I'm sure that
someone else might have some issues with my process, but every situation
is different. Having worked in a GLP lab for quite a few years, never
had any issues with FDA inspectors regarding any work that I have
submitted. 

 

Dusko Trajkovic

Pfizer Inc, La Jolla

 

________________________________

From: Jackie M O'Connor [mailto:Jackie.O'Connor <@t> abbott.com] 
Sent: Wednesday, May 07, 2008 5:39 AM
To: Trajkovic, Dusko
Cc: histonet <@t> lists.utsouthwestern.edu;
histonet-bounces <@t> lists.utsouthwestern.edu; Kim Merriam; Linke_Noelle
Subject: RE: [Histonet] GLP question

 


My lab has the capability of producing 600+ slides per day.  When we cut
initial slides, the microtomy is documented by the microtomist at the
time.   Staining is subsequently documented - since it may be performed
by another technician.    Once documentation of a procedural step is
made, that slide is already raw datum.  If a recut is needed at QC, the
reason for the recut is also documented, and the original slide is
retained.  The recut is subsequently documented, as well as whether or
not the desired goal (missing mammary) was achieved.    Gotta love the
world of GLP.    We may be documenting this to death - but it works
quite well.