We report HER2 using an automated image analysis system onsite. What requirements apply to us?
Image analysis can be an effective tool for achieving consistent interpretation; however, the pathologist is responsible for ensuring that the result provided by image analysis reflects measurement of invasive carcinoma only, and not DCIS or benign tissue. Image analysis equipment, just as other laboratory equipment, must be calibrated and subjected to regular maintenance and internal quality control evaluation. Image analysis procedures must be validated before implementation. All laboratories that report results of HER2 testing are required to enroll in a CAP approved PT program. Laboratories that do HER2 staining by IHC and use image analysis for interpretation and reporting are required to enroll in an IHC-based PT program and report the results following the usual testing and reporting methods used. All labs participating in HER2 PT must provide results for all PT challenges regardless of specific methods of testing used. If the PT program includes manual scoring of virtual slides
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