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: bszpu...@umail.iu.edu > To: histonet@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" <jvick...@springfieldclinic.com> > > Subject: [Histonet] New lab setup > > To: "histonet@lists.utsouthwestern.edu" > > <histonet@lists.utsouthwestern.edu> > > Message-ID: > > < > > 9b1a1501a800064397369bd8072e6bca984...@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: jvick...@springfieldclinic.com<mailto: > > jvick...@springfieldclinic.com> > > > > > > This electronic message contains information from Springfield Clinic, LLP > > that may be confidential, privileged, and/or sensitive. This information is > > intended for the use of the individual(s) or entity(ies) named above. 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