The following is a copy of validation protocol I received from CAP...
Dear Andrew, Here is the information for ANP.23120: To validate a new processing schedule the user should run tissue samples in duplicate. Side by side samples of the tissue that have been fixed for the same amount of time and are of the same size and thickness. Reagents on the processor should be of the same age and quality, i.e. all fresh reagents. Process, embed cut and stain slides (at the same time). The quality of the blocks should be evaluated on tissue quality I.e. Firmness, ease of cutting etc. The slides can be blind evaluated with the pathologist not knowing which processing schedule was used. Grade on quality of section and staining quality. The new process schedule must be of equal or better quality before put into use. This method can also be used when using the same processing schedule but setting up a new processor of the same model or when setting up a new brand of processor. Multiple common tissue types should be evaluated. Fake biopsies can be created so that patient tissues are not compromised. If you are changing a specific program on a single processor, like you are adjusting the ties or reagents on a breast tissue program. You run the first set of samples on the processor using the routine program and the run the duplicate set of tissues on the same processor using the new program to be validated. When validating programs for a new processor (especially when the new processor is a new brand or different model) you run the first set of tissues on the routine program on the old processor and the second set using the same program on the new processor. I hope this information has been helpful. Sincerely, Arlene Clancy MBA MT(ASCP)SC Technical Team, CAP Accreditation Programs College of American Pathologists Andrew Horvath, MBA, MA Interim Operations Manager 303-770-4848 (O) 303-770-6641 (fax) Colorado GI Pathology 7346 S. Alton Way Suite 10E Centennial, CO 80112 -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Matthew Roark Sent: Thursday, June 20, 2013 9:25 AM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Validation Protocols Would anybody be willing to share their protocol/policy for the validation of a new IHC stainer and/or tissue processor? Thanks!! Matthew Roark- HT/HTL(ASCP)CM Histology Specialist Saint Francis Medical Center 211 Saint Francis Drive Cape Girardeau, MO 63703 573-331-5267 <mailto:mro...@sfmc.net> mro...@sfmc.net <http://www.sfmc.net> http://www.sfmc.net _______________________________________________ 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