The laboratory approach to patient safety.

edical errors have a great impact on patient outcomes, since they can cause patients serious injury or even result in death. In 2000, in U.S. hospitals, medical errors were estimated to cause between 44,000 and 98,000 deaths annually, making preventable medical errors the eighth leading cause of death in the nation, with an estimated cost of $17 billion. Despite all efforts, it appears that the high quality of healthcare is not yet a universal reality; and further improvement is needed, as reported in the first National Health Care Quality Report, prepared by the Agency for Healthcare Research and Quality, using a variety of national data sources. As part of the overall healthcare system, clinical laboratories are also vulnerable to medical errors. Considerable efforts were made by laboratory professionals and other stakeholders to decrease testing errors. Minimal quality requirements were set through regulations, both for laboratory testing and for manufacturing of safe and efficacious medical equipment and reagents. Also, nonregulatory approaches, such as laboratory standards, participation in various quality-improvement programs, voluntary reporting of adverse events, and introduction of successful approaches from other industries — like Six Sigma or Lean — have greatly impacted the quality of laboratory testing. In order to facilitate further improvements in laboratory service — and better collaboration and coordination within the healthcare system — the Centers for Disease Control and Prevention (CDC) and nearly 40 partners M