I believe the point of validating is supposed to be to use samples that are processed in your own facility, so if you use controls you have not fixed and processed yourself it would not be valid.
Regards, Patsy Patsy Ruegg, HT(ASCP)QIHC IHCtech, LLC Fitzsimmons BioScience Park 12635 Montview Blvd. Suite 215 Aurora, CO 80010 P-720-859-4060 F-720-859-4110 wk email pru...@ihctech.net web site www.ihctech.net This email is confidential and intended solely for the use of the Person(s) ('the intended recipient') to whom it was addressed. Any views or opinions presented are solely those of the author. It may contain information that is privileged & confidential within the meaning of applicable law. Accordingly any dissemination, distribution, copying, or other use of this message, or any of its contents, by any person other than the intended recipient may constitute a breach of civil or criminal law and is strictly prohibited. If you are NOT the intended recipient please contact the sender and dispose of this e-mail as soon as possible. -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of tonia.richm...@gracepathology.com Sent: Thursday, May 06, 2010 9:28 AM To: McMahon, Loralee A Cc: histonet@lists.utsouthwestern.edu; thisis...@aol.com Subject: SPAM-LOW: RE: [Histonet] Responses to IHC CAP Validation question If you are a brand new lab, how do you validate IHC if you are no= 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.=ichm...@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=alee_mcma...@urmc.rochester.edu> Sent by: histonet-boun...@lists.u=southwestern.edu Date: 04/28/2010 02:01PM Subject: RE: [Histonet] Re=ponses to IHC CAP Validation question Any inspection that I have under=one 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= 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= easy. But when you are validated for more hard to find markers (SV-=0) then fewer cases is acceptable. We always throw in a slide that w= know will not stain for sv-40 like a tonsil - then you can say it has spe=ificity. Any inspector that I have come across is usually understanding=f 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=morial Hospital Department of Surgical Pathology (585) 275-7210 ______________________ 5F__=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= 2:47 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] R=sponses to IHC CAP Validation question The following is one respone= rec'd: 1. I asked CAP who told me that they do not currentl= have a guideline on validating but that they recommend what is in t=e following book: Quality Management In Anatomic Pathology, Promoting P=tient Safety Through Systems Improvement and Error by Raouf E. Nakhl=h, MD & Patrick Fitzgibbons, MD editors sold by CAP ! Chapter 8-=uality Management in IHC That is what we follow. I. Get a new antib=dy and optimize it with your positive control. II. Once optimized you n=ed to run it on cases expected to be positive (how many?) "a suffien= size ..." III. Must also be run on cases expected to be negative. (how=any? 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 =hat. (ex. some of the hormones we just use a pituitary) ___________________ ______________________ 5F__=5F__ Histonet mailing list Histonet@lists.utsouthwestern.edu =2]http://lists.utsouthwestern.edu/mailman/listinfo/histonet ______________________ 5F__ ______________________ Histo=et mailing list Histonet@lists.utsouthwestern.edu [3]http://l=sts.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