Exploring the iceberg of errors in laboratory medicine.

The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories, and currently available evidence demonstrates that the pre- and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. In particular, most errors are identified in pre-pre-analytic and post-post analytic steps outside the walls of the laboratory, and beyond its control. However, in a patient-centered approach to the delivery of health care services, there is the need to investigate any possible defect in the total testing process that may have a negative impact on the patient. In fact, in the interests of patients, any direct or indirect negative consequence related to a laboratory test must be considered, irrespective of which step is involved and whether the error is caused by a laboratory professional (e.g., calibration or testing error) or by a non-laboratory operator (e.g., inappropriate test request, error in patient identification and/or blood collection). Data on diagnostic errors in primary care and in the emergency department setting demonstrate that inappropriate test requesting and incorrect interpretation account for a large percentage of total errors whatever the discipline involved, be it radiology, pathology or laboratory medicine. Patient misidentification and problems in communicating results, which affect the delivery of all diagnostic services, are widely recognized as the main goals for quality improvement. Therefore, some common problems affect diagnostic errors, although specific faults characterising errors in laboratory medicine should lead to preventive and corrective actions if evidence-based quality indicators are developed, implemented and monitored. The lesson we have learned is that each practice must examine its own total testing process to discover its weaknesses and identify appropriate remedies.