Overview of the Clinical Immunohistochemistry Laboratory: Regulations and Troubleshooting Guidelines

Immunohistochemical procedures have become an integral part of the clinical laboratory routine, evolving from a research tool to a diagnostic necessity in pathology. As a specifically defined laboratory section, the Immunohistochemistry Laboratory must meet federally mandated standards of operation as defined in the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) (1 ). The published guidelines for the practice of pathology do not include regulations devoted exclusively to immunohistochemistry; however, within the Federal Register (Section 493.1259, p. 7170) are CLIA regulations governing the use of “special stains” in the practice of pathology that can be applied to the immunoperoxidase procedures.