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

The field of Clinical Immunohistochemistry (IHC) is beset with a high error rate, an order of magnitude higher than in other types of clinical laboratory testing. Despite the many improvements in the field, these errors have persisted over the last 2 decades. The improvements over the years include an extensive literature describing the potential causes of errors and how to avoid them. More stringent regulatory guidelines have also been implemented. These measures reflect the standard view is that fixing the broad confluence of causes of error will address the problem. This review takes a different tack. To understand the high error rates, this review compares Clinical IHC laboratory practice to practices of other clinical laboratory disciplines. What aspects of laboratory testing that minimize errors in other clinical laboratory disciplines are not found in Clinical IHC? In this review, we seek to identify causal factors and underlying root causes that are unique to the field of Clinical IHC in comparison to other laboratory testing disciplines. The most important underlying root cause is the absence of traceable units of measure, international standards, calibrators that are traceable to standards, and quantitative monitoring of controls. These tools and practices (in other clinical laboratory disciplines) provide regular accurate feedback to laboratory personnel on analytic test performance.