The laboratory is a key partner in assuring patient safety

Medical errors have a great impact on patient outcomes. They can cause serious injury to patients or even result in their deaths. However, morbidity and mortality can sometimes be prevented by the timely and effective action of health care workers. Several IOM Reports have focused on the problem of errors in the United States health care system and identified gaps that need to be addressed. As part of the overall health care system, clinical laboratories are vulnerable to medical errors. Because of significant efforts on the part of both the laboratories and the manufacturers of laboratory equipment and reagents, the errors in the analytic phase of the total testing process now represent the smallest portion of testing errors. Currently, laboratory testing errors occur most frequently in the preanalytic phase. The primary reason for the high prevalence of preanalytic errors is that, at the present time, it is difficult to monitor all preanalytic variables and to implement necessary improvement processes, particularly when some of the variables (like phlebotomy) are not under the control of the laboratory. Considerable efforts have been made by laboratory professionals and other stakeholders to decrease testing errors. Minimal quality requirements have been set through regulations for both laboratory testing and the manufacture of medical equipment and reagents. At the same time, nonregulatory approaches have greatly affected the quality of laboratory testing. These include laboratory standards, various quality improvement programs, voluntary reporting of adverse events, and, in the near future, the National Report on the Quality of Laboratory Services. The introduction of successful approaches from other industries, such as Six Sigma and Lean, also will help reduce the rate of laboratory errors. The clinical laboratory has done more than most other sectors of health care to decrease the occurrence of medical errors, making it a key partner inpatient safety.