[Histonet] New lab setup

[Vickroy, James]

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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