Immunohistochemical and immunocytochemical assays are highly complex diagnostic analyses used to aid in the accurate identification and biologic characterization of tissue types in neoplastic and nonneoplastic diseases. Immunohistochemical tests are applied mainly to the diagnosis of neoplasms. Some immunohistochemical tests provide information of important prognostic and predictive value in selected human neoplasms and, as such, are often critical for the appropriate and effective treatment of patients. This document provides recommendations and opinions of the Canadian Association of Pathologists-Association canadienne des pathologistes National Standards Committee/Immunohistochemistry relevant to clinical immunohistochemical terminology, classification of immunohistochemical tests based on risk assessment, and quality control and quality assurance and summarizes matters to be considered for appropriate immunohistochemical/immunocytochemical test development, performance, and interpretation in diagnostic pathology and laboratory medicine.