Immunohistochemistry (IHC) is the most common application of immunostaining. It involves the process of selectively identifying antigens in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues. Over the past 10-15 years, immunohistochemistry has grown in its service line and complexity to the point where some departments have an entirely separate department and leadership team managing this section. It has gone from being purely a morphological support tool to more recently playing an integral role in the determination of the role of therapeutic regimens in a patient’s treatment options. Having a solid quality improvement program to support your immunohistochemistry service line is crucial to its success and imperative to assuring patient safety and regulatory compliance.
This presentation is going to review many of the requirements as associated with the implementation and ongoing surveillance of IHC within the department. This will include the review of initial validation and performance verification along with methods for ongoing validation supporting the process of reagents and consumables cycling through the inventory. We will discuss recommendations for the monitoring of results and the successful participation proficiency testing. Additionally, we will touch upon what is necessary in terms of policies and procedures to support the operation as well as demonstrate examples of how to ensure all necessary documents are in place in order to show effective evidence of compliance during an inspection.