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Donald van Hecke

IHC and process validation

Handout (pdf 54p)

Handout (pdf 14p)


Today, pathology labs are facing many challenges to provide the optimal quality and service. One of the most critical steps is immunohistochemistry (IHC).

Immunohistochemical staining is a multi-step and complex process where the results are influenced by multiple parameters. Standardization of this process is crucial to obtain high quality and reliable results but is sometimes difficult to achieve. In addition, there is a growing demand from regulations and accreditation programs. In this context, process validation might provide a helpful tool.

This presentation will give an overview of a method for process validation used in our lab and based on the “M model”. This model enables you to approach every step in the total IHC process in a systematic way. The process steps are divided into  following categories : “Machine, Means, Men and Methods” - hence the “M model”. Potential critical factors in pre-analytical, analytical and post-analytical steps are listed based on experience, guidelines and recommendations. This list subsequently becomes the basis for a risk analysis (FMEA, Failure Mode and Effects Analysis) resulting in a risk priority number  assigned to each factor influencing the process. Critical points within the IHC process are validated in order to meet the predetermined acceptance criteria which are crucial to obtain consistent and high quality results. The use of controls together with other monitoring instruments will keep the IHC process in a validated state and minimize the risk for errors, ensuring a robust and standardized process.

The systematic mapping  and validation of critical points within the process will provide the framework for “in-house” standardization.


Donald Van Hecke is senior/head histotechnologist and quality coordinator at the pathology department of the AZ St. Lucas hospital in Bruges – Belgium. He has more than 20 year experience in histotechnology, immunohistochemical staining and special stains, is first author on international papers, former Belgian IHC conference organiser and guest speaker on topics related to IHC, standardization/ validation, lab automation and quality management. The pathology department is currently preparing for ISO 15189 accreditation this year.

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