Overview of the Clinical Immunohistochemistry Laboratory: Regulations and Troubleshooting Guidelines
Patricia A. Fetsch, Andrea D. Abati · Humana Press eBooks · 2003
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. These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.