A Root Cause Analysis Into the High Error Rate in Clinical Immunohistochemistry

Area of Science:

• Clinical laboratory science
• Biomedical diagnostics
• Pathology

Background:

• Clinical Immunohistochemistry (IHC) exhibits significantly higher error rates compared to other clinical laboratory disciplines.
• Despite decades of improvements, including extensive literature and stricter regulations, persistent high error rates in IHC remain a critical issue.

Purpose of the Study:

• To identify unique causal and root factors contributing to high error rates in Clinical IHC by comparing its practices to other laboratory disciplines.
• To pinpoint specific deficiencies in Clinical IHC that differentiate it from lower-error laboratory testing fields.

Main Methods:

• Comparative analysis of laboratory practices between Clinical IHC and other clinical laboratory disciplines.
• Identification of error-minimizing aspects present in other disciplines but absent in Clinical IHC.

Main Results:

• The primary underlying root cause identified is the absence of traceable units of measure, international standards, and traceable calibrators in Clinical IHC.
• Quantitative monitoring of controls, a practice that provides crucial feedback in other disciplines, is lacking in Clinical IHC.

Conclusions:

• The lack of standardization and quantitative feedback mechanisms unique to Clinical IHC is the fundamental reason for its persistent high error rates.
• Implementing traceable standards, calibrators, and quantitative controls, as seen in other disciplines, is essential for improving the accuracy and reliability of Clinical IHC.