Traceability in laboratory medicine.

BACKGROUND In patient and population samples, generation of analytical results that are comparable and independent of the measurement system, time, and location is essential for the utility of laboratory information supplied in healthcare. Obtaining analytical measurement results with such characteristics is the aim of traceability in laboratory medicine. As awareness of the benefits of having traceable measurement results has increased, associated efforts have been directed toward making traceability a regulatory requirement and developing approaches to enable and facilitate the implementation of traceability. Although traceability has been a main focus of many laboratory standardization activities in the past, discussions are still ongoing with regard to traceability and its implementation. CONTENT This review provides information about the traceability concept and what needs can be fulfilled and benefits achieved by the availability of traceable measurement results. Special emphasis is given to the new metrological terminology introduced with this concept. The review addresses and describes approaches for technical implementation of traceable methods as well as the associated challenges. Traceability is also discussed in the context of other activities to improve the overall measurement process. SUMMARY Establishing metrological traceability of measurement results satisfies basic clinical and public health needs, thus improving patient care and disease control and prevention. Large advances have been made to facilitate the implementation of traceability. However, details in the implementation process, such as lack of available commutable reference materials and insufficient resources to develop new reference measurement systems continue to challenge the laboratory medicine community.