Vesper are grateful to D. Stockl for discussing the manuscript. https://doi.org/10.1088/0957-0233/16/11/002, [5] Orji NG, Dixson RG, Cordes AM, Bunday BD, Allgair JA (2011) Measurement traceability and quality assurance in a nanomanufacturing environment. 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. the contents by NLM or the National Institutes of Health. The same year, the Cooperation on International Traceability in Analytical Chemistry was formed to encourage the broad realization of traceability in analytical chemistry (2). Print 2022 Apr 26. https://doi.org/10.1117/1.3549736, [6] Karam LR (2014) Measurement traceability in medical physics. Global database of reference materials and methods: Using freely available lists and catalogues publicise available reference materials and methods that meet agreed standards, including information on commutability and measurement uncertainty, Provide educational support materials to promote the importance of traceability in laboratory medicine. Traceability, Reference Systems and Result Comparability - PMC The importance of traceability in laboratory medicine Kane J, Middle J, Cawood M. Measurement of serum testosterone in women; what should we do?. To achieve traceability of measurement results to standards maintained by NIST, you need to reference your measurement results through an unbroken chain of calibrations, including determining the uncertainties at each step, to NIST standards as the specified references. Buttner J. Thus methods applied in diagnostic measurements must be accurate, precise, specific and comparable among laboratories. In the case of a differential white blood cell count that yields 63 neutrophils out of 100 white blood cells, saying that the measured value 63 is traceable to the unit 1 is as trivial and as unproductive as saying that 63 1 = 63. Once defined, the IU is passed to all further International Standard preparations by use of a traceability protocol. The latter is especially helpful when analytical performance goals have not been defined. One of these programs is the NIST Traceable Reference Material Program for Gas Standards, established in 1992 in partnership with the U.S. Environmental Protection Agency (EPA) and specialty gas companies to increase the availability of standard gas mixtures with certified composition that support the Emissions Trading provision of the 1990 Clean Air Act. These networks have established specific performance criteria and assure compliance through regular assessments. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. The NIST Policy on Traceability also addresses the role of NIST in providing its customers with the tools they need (a) to assist them in establishing traceability of their measurement results, and (b) to assess the claims of traceability made by others. ISO Guide 17034:2016. Although the measurement results in a calibration or measurement certificate can be considered to be certified by NIST as being traceable to NIST reference standards at the time the measurements were performed at NIST, no such certification extends automatically to measurement results that a user will obtain using an instrument calibrated by NIST or using a NIST Standard Reference Material. One key element of . Here are some example goals: In particular, if the data are not part of a NIST compilation of evaluated data, then care should be taken to assess the expressed uncertainty, and the literature checked for additional or updated values, for comparison. This linkage is established via criteria and protocols defined by NIST to meet the needs of the community served. Claiming that counts are traceable to the SI is too much of a simplification because it neglects the fact that counting inextricably involves the definition of what is being counted, and the standard that underlies this definition is not part of the SI. is the individual or organization that supplies a measurement result for use, whose metrological traceability is being asserted. ISO/IEC Standard 17025:2017. Communicates, especially where claims expressing or implying the contrary are made, that NIST does not define, specify, assure, or certify metrological traceability of measurement results other than those that NIST itself provides, either directly or through an official NIST program or collaboration. Certain portions of the chain can be established by various organizations or groups, as outlined in ISO 17511 (4) and further described in Table 1 . Since this function and the inputs determine the output, and the inputs are traceable, then according to the answer to Question 5.2.5 the consensus value will be traceable as well. 2022 Feb 18;60(5):669-674. doi: 10.1515/cclm-2022-0038. Ann Clin Biochem 2011; 48: 393-409 Establishing traceability for measurement procedures requires considerable resources. Traceability in laboratory medicine full-screen Fig. Examples would be measurement procedures specified by the IFCC for the measurement of enzymes such as creatine kinase, lactate dehydrogenase, and aspartate aminotransferase [as described in a recent review (29)] or by the International Council for Standardization in Hematology for the measurement of the number concentration of erythrocytes and leukocytes in human blood. Unable to load your collection due to an error, Unable to load your delegates due to an error. Serum testosterone assays: accuracy matters. Beastall GH. Measurements are traceable to an international conventional reference measurement procedure (which is not primary), but there is no international conventional calibrator and no metrological traceability to SI. Reference materials producers adhering to these requirements can use the NTRM certification mark, NTRM(CM). The mission of the National Institute of Standards and Technology (NIST) is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. Standardized templates for such designations of measurands can be found in an IFCC/International Union of Pure and Applied Chemistry database (24). There are many motivations to ensure traceability in measurement. For example, when a Jaffe method is used the measurand is serum creatinine although alkaline-picrate reactive substances are actually measured. The conventional position has been to say that counts are traceable to the unit 1, which is the neutral element in the SI. Traceability in laboratory medicine aims to reduce between method variability so that results are independent of time or location. and transmitted securely. Metrological Traceability is defined2 as the "property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty." Also, establishing traceability for mass standards with masses much smaller than 1 kg required a chain of multiple calibrations, whose uncertainty increased in proportion to the number of mass comparisons involved. are Certified Reference Materials (CRMs) that are certified by NIST in collaboration with a secondary standards producer, with a well-defined metrological traceability linkage to existing SRMs or primary standards. Since the following terms may be used throughout this document in ways that are specific to NIST, their meaning is reviewed and clarified as follows: is to provide support for the claim of traceability of a particular measurement result. NIST documents the process by which it establishes traceability of its own measurement results as part of the NIST Quality System for Measurement Services [35]. Section 3 transcribes the corresponding directive, NIST P 5800.00, which came into effect on May 31st, 2019. The .gov means its official. Such standards, however, are typically prepared in an aqueous matrix and are usually not commutable with native samples measured using routine measurement procedures; thus they cannot be used to directly calibrate routine procedures. The IFCC-IUPAC coding system: properties and units in the Clinical Laboratory Science (Wash DC) Commission on nomenclature, properties and units (C-NPU). Stated references may range from a corporate standard to a certified primary reference material that embodies a unit of the Systeme International (SI).1 These reference materials must have certain well-defined characteristics, such as homogeneity and stability, as described by the International Organization for Standardization (ISO) (25) and CLSI(26). Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, et al. In laboratory medicine meaningful measurements are essential for diagnosis, risk assessment, treatment and monitoring of patients. (Being a partition means that different subsets have no elements in common, and their union is the set that has been partitioned.) NIST only certifies the traceability of measurement results that NIST itself provides, either directly or through an official NIST program or collaboration. Cali JP. Therefore, their concentrations in serum water differ from their concentrations in serum. Author Contributions:All authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article. Therefore, establishing metrological traceability is a key component in laboratory standardization efforts, which are comprehensive activities directed toward the overall improvement of the measurement process and of the use of measurement results. A NIST customer or collaborator may state as a fact that calibrations provided by NIST are used in part to establish metrological traceability to the SI or other specified reference using the results of NIST measurements. Introduction: strategies to set global quality specifications in laboratory medicine. The certified and non-certified values are described in separate sections in the SRMs documentation: Certificate for physical or engineering performance properties, and Certificate of Analysis for specific chemical properties. HHS Vulnerability Disclosure, Help The certified values are described in a Certificate of Traceability. The conference will be divided into four key themes - climate action, smallholder livelihoods, traceability and data, and regenerative agriculture - identified for their impact on the sustainability of the cotton sector. The assay manufacturer is responsible for establishing and documenting metrological traceability for commercially available methods. Similarly, a cell containing a vapor of cesium-133 atoms excited to a Rydberg state can be used as a sensor to measure electric field strength [32] [33], which is intrinsically traceable to the SI in the sense that it enables measurements depending only on the electric dipole moment of these atoms and on the Planck constant, which now has a fixed value. An SRM certificate also contains an expiration date. Metrological traceability in clinical biochemistry. The principles of a reference measurement system for establishing metrological traceability are described in the ISO17511:2003 document [6]. The evolving role of commutability in metrological traceability. Traceability in Laboratory Medicine: What is it and Why is it The wedge on the right indicates that the uncertainty increases cumulatively at each step in the traceability chain. NISTs Calibration Program, Standard Reference Materials Program, and the Weights and Measures Program make up the largest integrated national measurement transfer system in the world. Or it may be long if the user references other calibrations in a chain of calibrations back to stated references developed and maintained by NIST. Direct customers of NISTs measurement services take advantage of the opportunity to tie their internal measurement standards to NIST standards and hence, to the SI units. Title 15, Chapter 7A, Section 290(a), NIST Traceable Reference Material Program for Gas Standards, National Institute of Standards and Technology, Practical Tool for Establishing Traceability in Chemical Measurements, The NIST Reference on Constants, Units, and Uncertainty, https://doi.org/10.1088/0957-0233/16/11/002, https://doi.org/10.6028/NIST.SP.260-136-2020, https://doi.org/10.6028/NIST.SP.260-126rev2013, www.bipm.org/en/publications/guides/gum.html, https://physics.nist.gov/Pubs/guidelines/TN1297/tn1297s.pdf, https://www.bipm.org/en/publications/si-brochure/, https://www.encyclopediaofmath.org/index.php/Peano_axioms, https://doi.org/10.1088/0026-1394/53/5/A46, https://doi.org/10.1109/TEMC.2016.2644616, https://www.nist.gov/nist-quality-system/, https://doi.org/10.1080/19315775.2015.11721732, Adopts for its own use and recommends for use by others the definition of traceability provided in the most recent version of the International vocabulary of metrology Basic and general concepts and associated terms (VIM. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer's selected measurement procedure and the . There are several reasons why efforts should be made to reduce between-method and between-laboratory variability [5]. Disclaimer. The CIPM, International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and ILAC Joint Committee for Traceability in Laboratory Medicine. EMN for Traceability in Laboratory Medicine Laboratory testing is at the heart of modern health care: an estimated 70% of medical decisions depend on in vitro diagnostics (IVDs). Traceability in laboratory medicine Authors Hubert W Vesper 1 , Linda M Thienpont Affiliation 1 Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. Disclaimer: The findings and conclusions in this manuscript are those of the author(s) and do not necessarily represent the views of the CDC/the Agency for Toxic Substances and Disease Registry. NIST Standard Reference Materials (SRMs). In zoology, for example, the diversity corresponding to differences due to gender, may be accommodated by designating allotypes: this makes it possible to recognize both mallard drakes and hens as members of the same species, Anas platyrhynchos, even though they look quite different from one another. These customers, in turn, use their standards to provide measurement services to their customers, to meet regulatory requirements, and to provide quality assurance in their manufacturing processes. is a reference material (RM) characterized by a metrologically valid procedure for one or more specified properties, accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability (ISO Guide 30, 2.1.2) [ISO 30:2015]. Cali JP. Traceability in laboratory medicine aims to reduce between method variability so that results are independent of time or location. Metrologia 53:A46A74. For example, the original certificate for NIST SRM 342a, Nodular Cast Iron Chip Form, was issued in 1999, and then reissued in 2019 following a reevaluation of the expanded uncertainties associated with the certified values. All calibration and test reports must declare the source of traceability and it is the responsibility of the user to determine which source is suitable for its needs. SRIs are issued as SRI 6xxx where xxx denotes a unique sequence of three digits. Metrologia 56(2):022001. https://doi.org/10.1088/1681-7575/ab0013, [31] Robinson IA, Schlamminger S (2016) The watt or Kibble balance: a technique for implementing the new si definition of the unit of mass. The aim of traceability in laboratory medicine is to link measurement results from a patient sample to a commonly accepted reference, making them comparable across measurement systems, location, and time (4). Other factors, such as assay selection, patient status, specimen collection and handling, and result reporting, are part of the preanalytical and postanalytical phases of the measurement process. The Standard Reference Data Program augments this system by providing scientists, engineers, and the general public with access to critically evaluated data necessary to perform state-of-the-art research and development. SRMs may also deliver non-certified information. Official websites use .gov Fraser CG, Kallner A, Kenny D, Petersen PH. Standardization of diagnostic materials; 2: problems of standardization in clinical chemistry. Standardization of procedures for the study of glucose-6-phosphate dehydrogenase. Journal of Medical Physics 39:13. The internal quality control in the traceability era - De Gruyter Merely having an instrument calibrated, even by NIST, is not enough to make the measurement result obtained using that instrument traceable to realizations of the appropriate SI unit or other specified references. Establishing traceability of measurement results should be linked to performance specifications that are based on clinical, research or public health needs. Fax 770-488-4192; e-mail. Laboratory medicine results influence a high percentage of all clinical decisions. For other measurement quantities, the reference may be a national standard defined de facto by a conventionally stated method. The following examples illustrate the types of documents that accompany reference materials currently available for sale by the Office of Reference Materials. Search for other works by this author on: International vocabulary of basic and general terms in metrology (VIM). The performance of such assessments at both the manufacturer and end-user levels helps assure traceability in reported patient results. As another example, NIST does provide calibration services for voltage, but only at discrete values of voltage. Topics covered include precision thermometry, temperature measurement by radiation thermometry, laser measurements, gage block calibration, time and frequency fundamentals, dimensional metrology, pressure, etc. Defining the component to be measured may pose challenges (42)(44). Refer to 5.1.1. A Century of Excellence in Measurements, Standards, and Technology, ed Lide DR (National Institute of Standards and Technology, Gaithersburg, MD), NIST Special Publication, Vol. All calibration and test reports must declare the source of traceability and it is the responsibility of the user to determine which source is suitable for its needs. [38] provide a list of certified reference materials that should be used to identify accepted references for delta value isotope ratio traceability statements. Or this uncertainty may be expressed only qualitatively, on an ordinal scale. Usually, data from NIST are qualified with uncertainties evaluated in accordance with the GUM. [30] Stock M, Davis R, de Mirands E, Milton MJT (2019) The revision of the SI the result of three decades of progress in metrology. Standardization of immunoassays for measurement of high-sensitivity C-reactive protein; phase I: evaluation of secondary reference materials. The first standard plays the role of what, in zoology and botany, is called the holotype (of a species): in the present context, it is the paradigmatic or ideal instantiation of what is being counted the typical neutrophil, when counting white blood cells, or the typical photon, when counting photons. Scientific publications that provide in-depth information about topics related to traceability are available in book format (34) and in volume 28 of the Clinical Biochemist Reviews (35). -, White GH. https://doi.org/10.6028/NIST.AMS.300-10. [36] Leaman DS, Hackett B (2020) National Voluntary Laboratory Accreditation Program Procedures and General Requirements (National Institute of Standards and Technology, Gaithersburg, MD). This reference can be a pure compound, a measurement procedure, or matrix-based materials with defined characteristics, which will be described later. Advertising the findings on a single instrument, device, or artifact could be misinterpreted as an indication of performance of other instruments, devices, or artifacts of identical or similar type. Measurement traceability is important because it gives you confidence and assurance that your measurement results agree with national or international standards within the statement of uncertainty in measurement. SRIs whose certificates include a statement of metrological traceability give these customers the ability to obtain traceable results when metrological traceability cannot be adequately established through reference materials or other calibrated measuring instruments. (2017, Metrologia 54(3): S34-S62, DOI 10.1088/1681-7575/aa6c0e). 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. http://www.citac.cc (Accessed August 2008). NIST National Institute of Standards and Technology NMI national . The traceability chain shown in Fig. BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP and OIML, JCGM 200:2012 (2017 version with minor corrections and informative annotations) Available at https://jcgm.bipm.org/vim/en/. Finally, a calibration chain must be defined (see Fig. [2] Belanger B, Rasberry S, Garner E, Brickencamp C, Ehrlich C (2001) Traceability: An evolving concept. 2NIST Uncertainty Machine (https://uncertainty.nist.gov) and NIST Consensus Builder (https://consensus.nist.gov), with users manuals available online, and supported by peer-reviewed publications: Lafarge & Possolo (NCSLI Measure Journal of Measurement Science 10(3): 20-27); Koepke et al. ISO 18153:2003, Metrological traceability and its implementation; a report. The goal for traceability is to assure that results used for care of patients are accurate and comparable over time and location. and transmitted securely. Clinical Chemistry journal has contributed to progress in lipid and lipoprotein testing for fifty years. ISO Guide 30:2015(E). The implementation of measurement traceability through the reference system provides one of the most important tools that supports the standardisation process in laboratory medicine. Such standards can be used for reference measurement procedures because the specificity of the reference procedure makes it insensitive to the matrix of the measurand. Traceability is realized by relating a measurement result to a stated reference through an unbroken chain of calibrations. (Refer also to the answer to Question 5.4.4. To establish traceability of the users measurement result to such reference standards, there must be a documented, unbroken chain of calibrations where each measured value must be qualified by a statement of the associated uncertainty. Strict criteria are required for inclusion in the JCTLM database, including evidence of commutability of reference materials and measurement uncertainty. An International Standard material is prepared with state-of-the-art purification and identification techniques, and its function is tested by the response of a biological system (a bioassay). Herold DA, Fitzgerald RL. Unbroken chain of calibrations or comparisons. JCTLM: Traceability, education and promotion. The measurement results with associated uncertainties are links in the traceability chain. Secure .gov websites use HTTPS Fraser CG, Petersen PH. It is not achieved by following any one particular procedure or using particular equipment. SRMs are issued as SRM xxxx where xxxx typically denotes a number between 1 and 5999, with a suffix that is either alphabetic or designates a lot number, indicating re-issues. The customer must have an appropriate internal measurement assurance program in place to assure the traceability of measurements of the same materials, or of measurements made using those materials as calibrants [34]. Infusino I, Bonora R, Panteghini M. Traceability in clinical enzymology. If well-accepted, scientifically sound and appropriate measurement equipment, practices, and procedures are used; if measurement values and uncertainties are calculated or otherwise established according to well-established protocols; and if the uncertainties are within accepted norms (both low and high) for the measurement application; then the customers measurement result might be considered traceable to NIST. The results of calibrations and tests performed by NIST apply only to the specific instrument or standard at the time of test unless otherwise clearly stated. Approaches should be developed in collaboration with the clinical communities to assure traceability to the highest available reference, while also ensuring that patient care remains consistent despite these changes. However, as explained in the answer to Question 5.1.6 above, the provider is responsible for providing the necessary information that the user assesses. This problem is reflected by differences in results among various methods that are nominally calibrated with the same WHO material (50)(51). Certified values delivered by a CRM are believed by NIST to be [9]: is to attest formally that traceability has been established for a specific measurement result. NIST Technical Note 1900. This definition leads to the definition of a quantity, which is the property of a phenomenon, body, or substance, to which a number can be assigned with respect to a reference (1). In this scenario, measurement procedures are defined by convention or consensus and no calibrators exist. Perform complex analyses such as next generation sequencing, pathology, microarray, and qPCR analysis. Steele BW, Wang E, Klee GG, Thienpont LM, Soldin SJ, Sokoll LJ, et al. Merely having an instrument or artifact calibrated at NIST is not enough to make the measurement result obtained by the user of the instrument traceable to reference standards developed and maintained by NIST. [3] Swyt DA, Phillips SD, Palmateer JW (2001) Developments at NIST on traceability in dimensional measurements. Available at https://physics.nist.gov/Pubs/guidelines/TN1297/tn1297s.pdf. Discussions on the subject of traceability over the past decade in the analytical laboratory community have had a profound effect in laboratory medicine, requiring manufacturers to reassess assay calibration procedures, challenging laboratory clinicians to develop tools and strategies to implement traceability, and calling for the general clinical laboratory community to adopt new terminology and to revisit the analytical measurement process for issues such as analyte definition and method calibration. Metrological traceability in clinical biochemistry - Graham H White, 2011
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