I hope you're correct. James Vickroy BS, HT(ASCP)
Surgical and Autopsy Pathology Technical Supervisor Memorial Medical Center 217-788-4046 -----Original Message----- From: Martha Ward [mailto:mw...@wakehealth.edu] Sent: Thursday, August 25, 2011 11:30 AM To: Carol Bryant; Vickroy, Jim; histonet@lists.utsouthwestern.edu Subject: RE: New CAP question We too have been performing ER and PR for at least 15 years, participate in CAP proficiency testing and, when we switched staining platforms a few years ago, validated the new antibody we switched to. I have interpreted the standard as necessary if you are introducing ER/PR in your lab. In my opinion you would not have to go back and revalidate something you did years ago just to have something to show at inspection time. We had our CAP inspection this summer and a similar question pertains to the HER2 assay, which we have also been doing for many years, and that is what I told our inspector, which seemed to satisfy them. Martha Ward, MT (ASCP) QIHC Manager, Molecular Diagnostics Lab Dept. of Pathology Wake Forest Baptist Medical Center Winston-Salem, NC 27157 336-716-2104 -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Carol Bryant Sent: Thursday, August 25, 2011 12:10 PM To: 'Vickroy, Jim'; histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: New CAP question Please respond to all. I would like the information also. Thank you, Carol -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Vickroy, Jim Sent: Thursday, August 25, 2011 12:01 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question One of the new CAP questions is ANP.22976 ER/PgR validation. If the laboratory performs immunohistochemistry for estrogen receptor and/or progesterone receptor as a prognostic/predictive marker on breast carcinoma, the laboratory has documented appropriate validation for the assays. In the note it says should include a minimum of 40 cases and validation should be performed by comparing the laboratory's results with another assay that has been appropriately validated. We have been doing ER/PR's for over ten years. Originally we compared our ER/PR testing with the old immunology method that used frozen breast tissue. We also compared our ER/PR results with another hospital. Problem is that this has been over ten years and we do not keep quality control records that long. Am I missing something? I know we use the FDA approved protocol from Ventana on our Ventana Benchmark XT. Should we do another validation study using Ventana or another hospital that is using the FDA approved method? Anybody understand what CAP is wanting and how to accomplish this? James Vickroy BS, HT(ASCP) Surgical and Autopsy Pathology Technical Supervisor Memorial Medical Center 217-788-4046 ________________________________ This message (including any attachments) contains confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this message. Any disclosure, copying, or distribution of this message, or the taking of any action based on it, is strictly prohibited. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet NOTICE OF CONFIDENTIALITY This message, including any attachments, is intended only for the sole use of the addressee and may contain confidential or privileged information that is protected by the State of Kentucky and/or Federal regulations. If you are not the intended recipient, do not read, copy, retain or disseminate this message or any attachment. If you have received this message in error, please call the sender immediately at (859)258-4000 and delete all copies of this message and any attachment. Any unauthorized review, use, disclosure, copying or distribution is strictly prohibited. Neither the transmission of this message or any attachment, nor any error in transmission or misdelivery shall constitute waiver of any applicable legal privilege. _______________________________________________ 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
