Responding to Large-Scale Testing Errors

Extensive use of automation in the clinical laboratory creates the potential for systematic errors that affect a large number of patient results before the error is discovered. When a large-scale testing error is found, the approaches recommended for responding to individual medical mishaps are often inadequate. This report uses 2 case studies to illustrate some of the unique challenges facing laboratory managers confronted with a large-scale testing error. We identify 9 distinct constituencies that may be impacted by large-scale testing errors, each of which requires laboratory management's thoughtful and timely attention.