scholarly journals A metrological traceability chain prevents circular reasoning in measurement design

2010 ◽  
Vol 15 (9) ◽  
pp. 491-492 ◽  
Author(s):  
Paul De Bièvre
Keyword(s):  
Metrological Traceability ◽  
Circular Reasoning ◽  
Traceability Chain ◽  
Measurement Design

scholarly journals Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

2019 ◽  
Vol 57 (4) ◽  
pp. 459-464 ◽  
Author(s):  
Marc Thelen ◽  
Florent Vanstapel ◽  
Pika Meško Brguljan ◽  
Bernard Gouget ◽  
Guilaine Boursier ◽  
...  
Keyword(s):  
Metrological Traceability ◽  
Measurement Procedure ◽  
Medical Laboratory ◽  
Clinical Samples ◽  
End User ◽  
Worst Case ◽  
Iso 15189 ◽  
Value Assignment ◽  
Traceability Chain ◽  
Medical Laboratories

Abstract ISO15189:2012 requires medical laboratories to document metrological traceability of their results. 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 manufacturer’s working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

Standardization of 18F and its use for the Romanian PET metrological traceability chain assurance

2014 ◽  
Vol 87 ◽  
pp. 14-18 ◽  
Author(s):  
M. Sahagia ◽  
R. Ioan ◽  
A. Luca ◽  
A. Antohe ◽  
C. Ivan ◽  
...  
Keyword(s):  
Metrological Traceability ◽  
Traceability Chain

Traceability in laboratory medicine: a global driver for accurate results for patient care

2017 ◽  
Vol 55 (8) ◽  
pp. 1100-1108 ◽  
Author(s):  
Graham H. Beastall ◽  
Nannette Brouwer ◽  
Silvia Quiroga ◽  
Gary L. Myers
Keyword(s):  
Reference Materials ◽  
Action Plan ◽  
Metrological Traceability ◽  
Laboratory Medicine ◽  
Geographical Differences ◽  
Traceability Chain ◽  
Stakeholder Groups ◽  
Universal Approach ◽  
Global Coordination ◽  
International Experts

AbstractLaboratory medicine results influence a high percentage of all clinical decisions. Globalization requires that laboratory medicine results should be transferable between methods in the interests of patient safety. International collaboration is necessary to deliver this requirement. That collaboration should be based on traceability in laboratory medicine and the adoption of higher order international commutable reference materials and measurement procedures. Application of the metrological traceability chain facilitates a universal approach. The measurement of serum cholesterol and blood HbA1cserve as examples of the process of method standardization where an impact on clinical outcomes is demonstrable. The measurement of plasma parathyroid hormone and blood HbA2 serve as examples where the current between-method variability is compromising patient management and method standardization and/or harmonization is required. Challenges to the widespread adoption of traceability in laboratory medicine include the availability of reference materials and methods, geographical differences, the use of variable units, complex analytes and limited global coordination. The global collaboration requires the involvement of several different stakeholder groups ranging from international experts to laboratory medicine specialists in routine clinical laboratories. A coordinated action plan is presented with actions attributable to each of these stakeholder groups.

Discussion on the Classification Criteria of Measurement System Level

2021 ◽  
Author(s):  
Yi-Ting Chen ◽  
Keyword(s):  
Measurement System ◽  
Metrological Traceability ◽  
Classification Criteria ◽  
System Level ◽  
Traceability Chain ◽  
Measurement Systems ◽  
Primary Measurement ◽  
Measurement Results ◽  
Definition Of

According to the definition of metrological traceability in ISO/IEC Guide 99:2007(VIM 3)[1], people in the metrology field can know the level of the measurement system in the metrological traceability chain by drawing the metrological traceability diagram on the measurement results. However, if someone want to further determine which level the measurement system belongs to, it should be classified as primary measurement system, secondary measurement system, or even other measurement systems. Because the definitions of terms such as primary measurement system, secondary measurement system and other measurement systems are not included in VIM 3[1], there’s no clear classification basis for the measurement system level. Therefore, this article will discuss the definitions of terms in VIM 3[1] that are more relevant to the classification of measurement system levels, then try to formulate the classification criteria, supplemented by case studies, and hope to serve as a reference for people in the metrology field when reviewing the measurement system and judging its system level.

scholarly journals Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!

2018 ◽  
Vol 56 (10) ◽  
pp. 1598-1602 ◽  
Author(s):  
Christa Cobbaert ◽  
Nico Smit ◽  
Philippe Gillery
Keyword(s):  
21St Century ◽  
Clinical Laboratory ◽  
Metrological Traceability ◽  
Laboratory Medicine ◽  
Test Results ◽  
Medical Test ◽  
Traceability Chain ◽  
Medical Laboratories ◽  
Medical Tests ◽  
Quantum Leap

Abstract In our efforts to advance the profession and practice of clinical laboratory medicine, strong coordination and collaboration are needed more than ever before. At the dawn of the 21st century, medical laboratories are facing many unmet clinical needs, a technological revolution promising a plethora of better biomarkers, financial constraints, a growing scarcity of well-trained laboratory technicians and a sharply increasing number of International Organization for Standardization guidelines and new regulations to which medical laboratories should comply in order to guarantee safety and effectiveness of medical test results. Although this is a global trend, medical laboratories across continents and countries are in distinct phases and experience various situations. A universal underlying requirement for safe and global use of medical test results is the standardization and harmonization of test results. Since two decades and after a number of endeavors on standardization/harmonization of medical tests, it is time to reflect on the effectiveness of the approaches used. To keep laboratory medicine sustainable, viable and affordable, clarification of the promises of metrological traceability of test results for improving sick and health care, realization of formal commitment among all stakeholders of the metrological traceability chain and preparation of a joint and global plan for action are essential prerequisites. Policy makers and regulators should not only overwhelm the diagnostic sector with oversight and regulations but should also create the conditions by establishing a global professional forum for anchoring the metrological traceability concept in the medical test domain. Even so, professional societies should have a strong voice in their (inter-) national governments to negotiate long-lasting public policy commitment and funds for global standardization of medical tests.

scholarly journals Application of systems thinking to the establishment of metrological traceability chains

2021 ◽  
pp. 3-7
Author(s):  
Oleh Velychko ◽  
Tetyana Gordiyenko
Keyword(s):  
Measurement Uncertainty ◽  
Systems Thinking ◽  
Metrological Traceability ◽  
Measuring Instruments ◽  
Measurement Standard ◽  
International Laboratory Accreditation Cooperation ◽  
Traceability Chain ◽  
Measurement Standards ◽  
Calibration Laboratories ◽  
Different Levels

International agreements in the field of metrology and accreditation of calibration laboratories are the basis for establishing global metrological traceability. Important elements of metrological traceability are calibration of measurement standards and measuring instruments, assessment of measurement uncertainty. The International Laboratory Accreditation Cooperation has a specific policy regarding on traceability of measurement results and estimation of measurement uncertainty in calibration. The partial concept diagram around metrological traceability in accordance with the International Vocabulary of Metrology is proposed. This diagram contains a total of nine metrological concepts, which have most of the associative relations. There are associative relations between the concept of metrological traceability chain and concepts of metrological traceability, measurement standard, calibration and calibration hierarchy, and through the concept of measurement standard with the concept of measurement uncertainty. Systems thinking to the analysis of state of proposed terminological system around metrological traceability was applied. For construction of generalized metrological traceability chain, all the established properties of the system elements around the terminology system of metrological traceability were taken into account. Generalized metrological traceability chain for different levels of the calibration hierarchy was proposed. The proposed chain can be used to develop appropriate chains for specific areas of measurement. To achieve this, it is necessary to determine the specific measured value, the required measurement uncertainty for different levels of the calibration hierarchy and select the necessary measurement standards. Such schemes should be used in national metrology institutes and calibration laboratories.

Metrological traceability of measurement results in chemistry: Concepts and implementation (IUPAC Technical Report)

2011 ◽  
Vol 83 (10) ◽  
pp. 1873-1935 ◽  
Author(s):  
Paul De Bièvre ◽  
René Dybkær ◽  
Aleš Fajgelj ◽  
D. Brynn Hibbert
Keyword(s):  
Metrological Traceability ◽  
Institutional Framework ◽  
Interlaboratory Comparisons ◽  
Traceability Chain ◽  
Measurement Result ◽  
Technical Report ◽  
Measurement Results ◽  
Flow Charts ◽  
Traceability Of Measurement Results

This IUPAC study aims at formulating recommendations concerning the metrological traceability of a measurement result in chemistry. It is intended to provide the chemical measurement community with a consistent view of the creation, meaning, and role of metrological traceability and its underpinning concepts. No distinction is made between measurement results obtained in “high metrology” and in the “field”. A description is given of the calibration hierarchies needed in different circumstances to arrive at metrological traceability along a metrological traceability chain. Flow charts of generic calibration hierarchies are presented as well as a variety of examples. The establishment, assessment, and reporting of metrological traceability are discussed, including the provision of metrological references by a metrological institutional framework and the role of interlaboratory comparisons.

Metrological traceability chain for pH measurement results

MAPAN ◽  
2010 ◽  
Vol 25 (3) ◽  
pp. 191-196 ◽  
Author(s):  
Petra Spitzer ◽  
Steffen Seitz
Keyword(s):  
Metrological Traceability ◽  
Ph Measurement ◽  
Traceability Chain ◽  
Measurement Results

Metrological traceability of calibration in the estimation and use of common medical decision-making criteria

2004 ◽  
Vol 42 (7) ◽  
Author(s):  
Linda M. Thienpont ◽  
Katleen Van Uytfanghe ◽  
Diego Rodríguez Cabaleiro
Keyword(s):  
Decision Making ◽  
Reference Materials ◽  
Medical Decision Making ◽  
Metrological Traceability ◽  
Laboratory Medicine ◽  
Medical Decision ◽  
Traceability Chain ◽  
Primary Reference ◽  
Decision Making Criteria

AbstractThis manuscript explains the establishment andvalidation of metrological traceability of calibration for routine measurement procedures using common medical decision-making criteria. Metrological traceability is considered the basis for achieving comparability of measurement results in laboratory medicine. This concept is supported by European legislation, which demands that manufacturers provide assurance andd emonstrate metrological traceability of in vitro Diagnostic Medical Devices. The guidance to comply with these legislative requirements is available in different CEN/ISO standards and is used as a basis of this manuscript. The goals andaccomplishments in metrological traceability of SI- and non-SI analytes is considered. Specific problems, such as non-availability of primary reference materials and measurement procedures, lack of official endorsement, andnon-commutability of certain reference materials are discussed. With respect to non-commutability, the use of split-sample measurements is advocated. Also, the expression of measurement uncertainty associatedwith the application of the metrological traceability chain is discussed. In addition, the needfor post-market vigilance assessment of traceable performance is considered. Finally, laboratory medicine scientific and professional societies, diagnostics manufacturers, and clinicians are urged to share responsibilities for understanding the implications of metrological traceability of routine measurements.

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