This article was accepted into the corpus but its outbound wikilinks were never NER-processed — typical at the deepest BFS hop or when the run's entity cap was reached. No expansion funnel to show.
| Joint Committee for Traceability in Laboratory Medicine | |
|---|---|
| Name | Joint Committee for Traceability in Laboratory Medicine |
| Abbreviation | JCTLM |
| Formation | 2002 |
| Type | International scientific committee |
| Headquarters | Geneva |
| Region served | Worldwide |
| Leader title | Chair |
Joint Committee for Traceability in Laboratory Medicine The Joint Committee for Traceability in Laboratory Medicine was established to promote metrology-based standards for clinical laboratory medicine and to ensure metrological traceability of routine in vitro diagnostics and laboratory measurements. It brings together experts from national metrology institutes, international health organizations, professional societys and regulatory agencys to coordinate standards for measurement comparability across healthcare systems and medical laboratory networks.
The committee was created following discussions involving the International Bureau of Weights and Measures, the World Health Organization, the International Organization for Standardization, and representatives from the International Federation of Clinical Chemistry and Laboratory Medicine and national metrology institutes such as the Physikalisch-Technische Bundesanstalt, the National Institute of Standards and Technology, and the National Metrology Institute of Japan that traced back to initiatives at the Bureau International des Poids et Mesures and conferences hosted by the European Commission and the Council of Europe. Founding meetings included delegates from the Centers for Disease Control and Prevention, the Food and Drug Administration, the Royal College of Pathologists, and academic groups from institutions like Karolinska Institutet, Johns Hopkins University, and Imperial College London to address variability identified in multicenter studies such as those coordinated by the World Health Organization and the International Consortium for Harmonization of Clinical Laboratory Results.
The committee’s mission aligns with mandates from the International Committee on Weights and Measures, the World Health Organization, and the International Organization for Standardization to achieve measurement traceability to International System of Units references for clinical analytes used in diagnostic tests. Objectives include establishing pathways among reference material producers like the Institute for Reference Materials and Measurements, central laboratories at institutions such as the National Physical Laboratory (United Kingdom), and clinical manufacturers including Roche, Abbott Laboratories, and Siemens Healthineers to reduce inter-laboratory variation identified in programs run by the College of American Pathologists and the European Federation of Clinical Chemistry and Laboratory Medicine.
Membership comprises representatives from major international bodies including the International Bureau of Weights and Measures, the World Health Organization, the International Organization for Standardization, the International Federation of Clinical Chemistry and Laboratory Medicine, national metrology institutes such as the National Institute of Standards and Technology and the Physikalisch-Technische Bundesanstalt, and regulatory agencies like the European Medicines Agency and the Food and Drug Administration. The committee operates through a steering group, technical working groups and liaison roles with organizations such as the Institute for Reference Materials and Measurements, the International Laboratory Accreditation Cooperation, and professional bodies including the Royal College of Pathologists and the American Association for Clinical Chemistry.
Technical work focuses on developing criteria for reference measurement procedures, reference material characterization, and calibration hierarchys consistent with documents from the International Organization for Standardization and the International Committee on Weights and Measures. Methods include interlaboratory comparison studies executed with partner laboratories like the National Physical Laboratory (United Kingdom), statistical analyses informed by techniques from researchers at Imperial College London and Johns Hopkins University, and coordination of commutability studies involving manufacturers such as Roche and Siemens Healthineers to ensure compatibility with clinical in vitro diagnostics and accreditation frameworks promoted by the International Laboratory Accreditation Cooperation.
The committee maintains a database of approved reference materials and reference measurement procedures and issues guidance aligned with standards such as ISO 15195 and documents from the International Organization for Standardization and the International Committee on Weights and Measures. Publications and technical reports reference collaborative work with the World Health Organization, the International Federation of Clinical Chemistry and Laboratory Medicine, and metrology institutes including the National Institute of Standards and Technology and the Physikalisch-Technische Bundesanstalt to support implementation in clinical networks like those overseen by the College of American Pathologists.
Through links with the World Health Organization, the International Organization for Standardization, the International Federation of Clinical Chemistry and Laboratory Medicine, national metrology institutes such as the National Institute of Standards and Technology, and regulatory agencies like the Food and Drug Administration and the European Medicines Agency, the committee influences global harmonization efforts. Its work informs proficiency testing programs run by the College of American Pathologists and accreditation practices promoted by the International Laboratory Accreditation Cooperation, contributing to efforts in multicenter clinical trials involving institutions like Karolinska Institutet and Johns Hopkins University and manufacturers such as Roche and Abbott Laboratories.
Critics point to dependence on voluntary compliance by manufacturers including Roche and Siemens Healthineers, limited resources compared with mandates held by bodies like the Food and Drug Administration, and the difficulty of achieving uniform adoption across diverse healthcare systems exemplified by contrasts between the National Health Service (England) and private systems in the United States. Technical challenges include establishing commutable reference materials and universally accepted reference measurement procedures for complex analytes, issues debated at meetings involving the International Organization for Standardization, the World Health Organization, and representatives from academic centers such as Imperial College London and Johns Hopkins University.
Category:Metrology Category:Clinical laboratory