[Histonet] New CAP question

[Vickroy, Jim]

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


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