Is participation in proficiency testing (PT) required for all sites that do HER2 testing?
Yes. In order to be compliant with the CAP/ASCO HER2 Guidelines, any laboratory that reports results of HER2 testing must participate in an accepted PT program (see exception below). The College’s Laboratory Accreditation Program (LAP) will require participation in a PT program by an accepted provider. Exception: Laboratories that interpret and report the results of HER2 testing by FISH in which the hybridization is performed at an outside laboratory should not enroll in proficiency testing for that assay due to PT Referral prohibitions; such laboratories must perform alternative assessment. This exception does not apply to laboratories that interpret and report the results of HER2 testing by immunohistochemistry when staining is done at an outside facility.
