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Published on: July 26, 2019
Quality Management of the Immunohistochemistry Laboratory: A Practical Guide
Justin M M Cates1, K Ashley Troutman
1Department of Pathology, Medical Center North C-3321, Vanderbilt University Medical Center, Nashville, TN.
Insights
Implementing quality management (QM) programs for immunohistochemistry (IHC) assays in Anatomic Pathology lacks specific guidance. This review pragmatically discusses QM principles and practices for IHC laboratories, covering quality control, quality assurance, and quality improvement.
Area of Science:
- Anatomic Pathology
- Laboratory Medicine
- Biomedical Science
Background:
- Current governmental regulations and guidelines offer limited specific direction for quality management (QM) in immunohistochemistry (IHC) assays.
- Effective QM is crucial for reliable IHC assay results in Anatomic Pathology.
Purpose of the Study:
- To provide pragmatic guidance on implementing QM programs for IHC assays.
- To discuss the core components and practices of QM in IHC laboratories.
Main Methods:
- Review of existing literature and guidelines.
- Discussion of QM principles including quality control, quality assurance, and quality improvement.
- Emphasis on practical implementation strategies for IHC.
Main Results:
- QM for IHC involves distinct yet interconnected objectives in quality control, quality assurance, and quality improvement.
- A pragmatic approach is necessary due to the lack of specific regulatory guidance.
Conclusions:
- Implementing robust QM programs for IHC assays requires a structured approach addressing control, assurance, and improvement.
- This review offers practical insights for Anatomic Pathology laboratories to enhance IHC assay quality.
Abstract:
Governmental regulations and most published guidelines do not provide specific guidance on implementation of quality management (QM) programs for immunohistochemistry (IHC) assays in Anatomic Pathology. QM of IHC consists of 3 main components: quality control, quality assurance, and quality improvement initiatives, each entailing distinctive but interrelated objectives. Discussion of the principles and some specific practices involved in these phases of QM of the IHC laboratory are therefore offered in this review, with an admitted emphasis on pragmatism.
