[Histonet] RE: New Lab Setup

[Joelle Weaver]

Just finished a lab set up and intial CAP inspection. I had VIPs and at least 5 processing programs. I did 20 samples each, documented the tissue type, dimensions, criteria for acceptability, microscopic review/morphology preservation using H & E staining sections, signed off by medical director. I did the same for each separate program using tissue appropriate to the program. Typed up a summary document, retained with validtion slides and blocks. No issues with CAP. 


Joelle Weaver MAOM, HTL (ASCP) QIHC

        
  

 
> Date: Wed, 18 Feb 2015 14:06:10 -0500
> From: bszpunar <@t> umail.iu.edu
> To: histonet <@t> lists.utsouthwestern.edu
> Subject: [Histonet] RE: New Lab Setup
> 
> Hi Jim,
> While I do not have quite the length of time in the field that you do, I do
> have been through this several times and have some thoughts.
> 
> First, to your question about how many samples is acceptable, I would say
> you should somewhat base this on your acceptability criteria. For example,
> if acceptability for your validation is 95% of the specimens being "overall
> acceptable", you should do either 20 or 40 (for your scope, I would pick 20
> personally), but NOT somewhere in between those numbers. The reason for
> this is you gain nothing in the land of percentages by doing, say 25. At
> 20, any more than one specimen that is "unacceptable" will throw you below
> 95%. At 40, you can have two outliers and still be within 95%.
> 
> That is just a hypothetical, but hopefully you get the gist. Essentially,
> don't give yourself more opportunities to fail the validation if it gains
> you nothing in the margin. If your application requires a more robust
> validation, go for 40 (a la prognostic IHC).
> 
> I would think an IHC/histochemistry validation would be overkill if you are
> validating your initial samples in parallel anyway. Just be sure to
> document that the results of the specimens were comparable to each other. I
> might have a different opinion if you were not using the exact same
> processors and doing some form of rapid/microwave processing instead.
> 
> Regards,
> Bryan
> 
> 
> 
> 
> 
> > Date: Wed, 18 Feb 2015 17:27:50 +0000
> > From: "Vickroy, James" <jvickroy <@t> SpringfieldClinic.com>
> > Subject: [Histonet] New lab setup
> > To: "histonet <@t> lists.utsouthwestern.edu"
> >         <histonet <@t> lists.utsouthwestern.edu>
> > Message-ID:
> >         <
> > 9B1A1501A800064397369BD8072E6BCA984027 <@t> E2K10DB.springfieldclinic.com>
> > Content-Type: text/plain; charset="us-ascii"
> >
> >
> > I am working on setting up  an adequate validation study for tissue
> > processing at a new lab.  I want it to be adequate but also not too labor
> > intensive or costly.  I have been in Histotechnology for over 36 years and
> > have done this before in the lab I can from.   Unfortunately sometimes I
> > make things more complicated than others.  I realize the standards for
> > testing new protocols and antibodies are defined in the CAP checklist but
> > routine tissue processing  just says to document the procedure and to run
> > parallel samples as a blind study.
> >
> > We are going to run only GI biopsies at first and I had planned on running
> > parallel samples with the department from my  previous employer.   I also
> > thought that down the road we may have more than a rapid biopsy program so
> > I should do a few larger samples at a regular processing schedule to
> > validate both schedules (rapid and normal).  I also thought that I should
> > pick out a couple of blocks for  representative special stains and IHC
> > stains tha we would compare even though the new lab will send everything to
> > the old lab for special stains and IHC stains.
> >
> > We have two processors and know I will also have to run a small validation
> > of each new processor.  I figured as I was validating the tissue processing
> > programs I would also be validating the first tissue processor.
> >
> > Both of our two processors will be VIP6(s) and the machines from my former
> > employer were also VIP6(s) which were of course validated.
> >
> > Can anyone share how many samples are adequate for tissue processing
> > program validation and new processor validation? In other words what have
> > you done and what was accepted by CAP since the wording of the question
> > does not state any particulars?   Also can you tell me if you think the
> > special stains and IHC stains comparison is necessary, given that all of
> > the stains will be done at the old lab and the only difference will be
> > where the tissues were processed.
> >
> > My original design of the study had 25 parallel samples but I am wondering
> > if that is overkill.
> >
> > Thanks
> >
> > Jim Vickroy
> >
> > Jim Vickroy
> > Histology Manager
> > Springfield Clinic, Main Campus, East Building
> > 1025 South 6th Street
> > Springfield, Illinois  62703
> > Office:  217-528-7541, Ext. 15121
> > Email:  jvickroy <@t> SpringfieldClinic.com<mailto:
> > jvickroy <@t> SpringfieldClinic.com>
> >
> >
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