You should pose that question to CAP via acc...@cap.org they answer quickly and when they do you can print out their answer and keep for when your inspectors come.
When I asked them that question, they said that it was usually at the discretion of the pathologist in charge. But instead of taking my word for It, email them and when you receive their response, print it. Then follow their instructions. Dana Settembre -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Schaundra Walton Sent: Monday, April 16, 2012 11:34 AM To: Histonet Subject: [Histonet] CAP Question I have a question regarding a new CAP checklist question dealing with ER/PR validation. The new question is ANP.22976 ER/PgR Validation and states: "If the laboratory performs immunohistochemistry for estrogen receptor (ER) and/or progesterone receptor (PgR) as a prognostic/predictive marker on breast carcinoma, the laboratory has documented appropriate validation for the assay(s). Note: Initial test validation should include a minimum of 40 cases (20 positive and 20 negative cases) for FDA-approved/cleared tests; laboratories should consider using higher numbers of test cases if a Laboratory Developed or Laboratory Modified Test is to be validated. Validation should be performed by comparing the laboratory's results with another assay that has been appropriately validated. Acceptable concordance levels are 90% for positive results and 95% for negative results. If significant changes are made to the testing methods (e.g. antibody clones, antigen retrieval protocol or detection system) revalidation is required. " Our original validation was done in 2005 and was performed with 20 cases. Do we need to revalidate to be compliant with this question? Should we start from scratch or just do an additional 20 cases? Any feedback is appreciated. Thanks! Schaundra Walton BS HTL(ASCP) Histology Supervisor _______________________________________________ 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