One important thing to remember is that you should make sure All material being used for validation is processed the same way. Will your control tissue be purchased or processed in your lab? Control tissue is used for validation but you should use tissue with various levels of positivity.
Beatrice Sullivan, HT(A.S.C.P.) HTL , AAS, CLSP(N.C.A.) AP Supervisor Shore Memorial Hospital 609-653-3590 tonia.richm...@gr acepathology.com Sent by: To histonet-bounces@ "McMahon, Loralee A" lists.utsouthwest <loralee_mcma...@urmc.rochester.edu ern.edu > cc "histonet@lists.utsouthwestern.edu" 05/06/2010 11:27 <histonet@lists.utsouthwestern.edu> AM , "thisis...@aol.com" <thisis...@aol.com> Subject RE: [Histonet] Responses to IHC CAP Validation question If you are a brand new lab, how do you validate IHC if you are no= t yet receiving patient specimens? Can the validation be done on cont rol tissues only? Sincerely, Tonia Richmond, AS, HT (ASCP) Chief Operations Officer = / Laboratory Grace Pathology PH: (501) 765-7367 Email: = [1]tonia.= richm...@gracepathology.com -----histonet-boun...@lists.utsouthwestern.edu wrote: ----- <= /FONT> To: "thisis...@= aol.com" <thisis...@aol.com>, "histonet@lists.utsouthwestern.edu" < ;histonet@lists.utsouthwestern.edu> From: "McMahon, Loralee A" <Lo= ralee_mcma...@urmc.rochester.edu> Sent by: histonet-boun...@lists.u= tsouthwestern.edu Date: 04/28/2010 02:01PM Subject: RE: [Histonet] Re= sponses to IHC CAP Validation question Any inspection that I have under= gone we have used the 25 to 30 case rule. Except for the Er/Pr//Her-2= . We use closer to 50 cases. We also use a TMA to make our live= s easier. The TMA contains known positives and known negatives. I= n cases of t-cell or b-cell markers or cytokeratins. 25 to 30 cases i= s easy. But when you are validated for more hard to find markers (SV-= 40) then fewer cases is acceptable. We always throw in a slide that w= e know will not stain for sv-40 like a tonsil - then you can say it has spe= cificity. Any inspector that I have come across is usually understanding= of this. But I am sure that there are exceptions to this.........esp ecially if they are not familiar with immunohistochemistry. Loralee McMahon, HTL (ASCP) Immunohistochemistry Supervisor Strong M= emorial Hospital Department of Surgical Pathology (585) 275-7210 ______________________ 5F__= _______________ From: histonet-boun...@lis= ts.utsouthwestern.edu [histonet-boun...@lists.utsouthwestern.edu] On Behalf= Of thisis...@aol.com [thisis...@aol.com] Sent: Wednesday, April 28, 201= 0 2:47 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] R= esponses to IHC CAP Validation question The following is one respone= I rec'd: 1. I asked CAP who told me that they do not currentl= y have a guideline on validating but that they recommend what is in t= he following book: Quality Management In Anatomic Pathology, Promoting P= atient Safety Through Systems Improvement and Error by Raouf E. Nakhl= eh, MD & Patrick Fitzgibbons, MD editors sold by CAP ! Chapter 8-= Quality Management in IHC That is what we follow. I. Get a new antib= ody and optimize it with your positive control. II. Once optimized you n= eed to run it on cases expected to be positive (how many?) "a suffien= t size ..." III. Must also be run on cases expected to be negative. (how= many? IV. In a situation where you cannot expect a lot of cases or such a case has never been presented in your lab, then you must say just = that. (ex. some of the hormones we just use a pituitary) ___________________ ______________________ 5F__= ___ Histonet mailing list Histonet@lists.utsouthwestern.edu = [2]http://lists.utsouthwestern.edu/mailman/listinfo/histonet ______________________ 5F__ ______________________ Histo= net mailing list Histonet@lists.utsouthwestern.edu [3]http://l= ists.utsouthwestern.edu/mailman/listinfo/histonet References 1. 3D"mailto:tonia.richm...@gracepathology.com" 2. 3D"http://lists.utsouthwestern.edu/mailman/listinfo/histonet" 3. 3D"http://=/ _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet