Developing an Internal Quality Assurance Program for Immunohistochemistry Interpretation of Her–2/neu

Abstract

The purpose of this initiative was to develop an in-house program that allows a comparison of pathologist interpretations of human epidermal growth factor receptor 2 gene (Her-2/neu) performed by immunohistochemistry (IHC). This comparison would drive uniformity in reporting between pathologists in the greater medical community and improve the precision of Her-2/neu interpretations and its utility as a predictive marker. The technical variance behind the process of Her-2/neu interpretations may lead to interpretative variability between pathologists. The technical variables were minimized by passing a single slide with a tissue microarray stained for Her-2/neu by IHC between pathologists at different laboratory sites for interpretation. The pathologist identities remained anonymous to the group. The results were reported by the pathologists to a single assessor. The results were compiled and distributed with each pathologist knowing only his/her own identification number as designated by the single assessor; 100% pathologist participation was achieved. The findings indicate a relatively consistent pattern of reporting between pathologists for Her-2/neu. By developing an internal quality assurance program to function in conjunction with external quality assurance testing, the technical staff and pathologists can collaboratively ensure optimal performance, interpretation, and reporting of results. (The J Histotechnol 33(2):85–92, 2010)Submitted December 22, 2009; accepted with revisions May 12, 2010.