Standardization of Diagnostic Immunohistochemistry Literature Review and Geisinger Experience

Context.-Immunohistochemistry has become an indispensable ancillary technique in anatomic pathology laboratories. Standardization of every step in preanalytic, analytic, and postanalytic phases is crucial to achieve reproducible and reliable immunohistochemistry test results. Objective.-To standardize immunohistochemistry tests from preanalytic, analytic, to postanalytic phases. Data Sources.-Literature review and Geisinger (Geisinger Medical Center, Danville, Pennsylvania) experience. Conclusions.-This review article delineates some critical points in preanalytic, analytic, and postanalytic phases; reiterates some important questions, which may or may not have a consensus at this time; and updates the newly proposed guidelines on antibody validation from the College of American Pathologists Pathology and Laboratory Quality Center. Additionally, the article intends to share Geisinger's experience with (1) testing/optimizing a new antibody and troubleshooting; (2) interpreting and reporting immunohistochemistry assay results; (3) improving and implementing a total immunohistochemistry quality management program; and (4) developing best practices in immunohistochemistry.