scholarly journals The utility of measurement uncertainty in medical laboratories

2020 ◽  
Vol 58 (9) ◽  
pp. 1407-1413 ◽  
Author(s):  
Federica Braga ◽  
Mauro Panteghini
Keyword(s):  
Measurement Uncertainty ◽  
Metrological Traceability ◽  
Measuring System ◽  
Medical Laboratory ◽  
Management Tool ◽  
Clinical Samples ◽  
Traceability Chain ◽  
Medical Laboratories

AbstractThe definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference) methods and/or materials, together with a clinically acceptable level of measurement uncertainty (MU), are fundamental requirements to produce accurate and equivalent laboratory results. The MU associated with each step of the traceability chain should be governed to obtain a final combined MU on clinical samples fulfilling the requested performance specifications. MU is useful for a number of reasons: (a) for giving objective information about the quality of individual laboratory performance; (b) for serving as a management tool for the medical laboratory and in vitro diagnostics (IVD) manufacturers, forcing them to investigate and eventually fix the identified problems; (c) for helping those manufacturers that produce superior products and measuring systems to demonstrate the superiority of those products; (d) for identifying analytes that need analytical improvement for their clinical use and ask IVD manufacturers to work for improving the quality of assay performance and (e) for abandoning assays with demonstrated insufficient quality. Accordingly, the MU should not be considered a parameter to be calculated by medical laboratories just to fulfill accreditation standards, but it must become a key quality indicator to describe both the performance of an IVD measuring system and the laboratory itself.

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.

scholarly journals Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Federica Braga ◽  
Mauro Panteghini
Keyword(s):  
Measurement Uncertainty ◽  
Plasma Potassium ◽  
Analytical Performance ◽  
Clinical Samples ◽  
C Reactive Protein ◽  
Medical Laboratories ◽  
Reactive Protein ◽  
Total Hemoglobin ◽  
Performance Specifications

Abstract Objectives Definition and fullfillment of analytical performance specifications (APS) for measurement uncertainty (MU) allow to make laboratory determinations clinically usable. The 2014 Milan Strategic Conference have proposed models to objectively derive APS based on: (a) the effect of analytical performance on clinical outcome; (b) biological variation components; and (3) the state of the art of the measurement, defined as the highest level of analytical performance technically achievable. Using these models appropriately, we present here a proposal for defining APS for standard MU for some common biochemical measurands. Methods We allocated a group of 13 measurands selected among the most commonly laboratory requested tests to each of the three Milan models on the basis of their biological and clinical characteristics. Both minimum and desirable levels of quality of APS for standard MU of clinical samples were defined by using information obtained from available studies. Results Blood total hemoglobin, plasma glucose, blood glycated hemoglobin, and serum 25-hydroxyvitamin D3 were allocated to the model 1 and the corresponding desirable APS were 2.80, 2.00, 3.00, and 10.0%, respectively. Plasma potassium, sodium, chloride, total calcium, alanine aminotransferase, creatinine, urea, and total bilirubin were allocated to the model 2 and the corresponding desirable APS were 1.96, 0.27, 0.49, 0.91, 4.65, 2.20, 7.05, and 10.5%, respectively. For C-reactive protein, allocated to the model 3, a desirable MU of 3.76% was defined. Conclusions APS for MU of clinical samples derived in this study are essential to objectively evaluate the reliability of results provided by medical laboratories.

ISO/TS 20914:2019 – a critical commentary

2020 ◽  
Vol 58 (8) ◽  
pp. 1182-1190 ◽  
Author(s):  
Ian Farrance ◽  
Robert Frenkel ◽  
Tony Badrick
Keyword(s):  
Measurement Uncertainty ◽  
Measurement Data ◽  
International Normalized Ratio ◽  
Medical Laboratory ◽  
Uncertainty In Measurement ◽  
Medical Laboratories ◽  
Functional Relationships ◽  
Critical Commentary ◽  
Combined Uncertainty ◽  
Expression Of Uncertainty

AbstractThe long-anticipated ISO/TS 20914, Medical laboratories – Practical guidance for the estimation of measurement uncertainty, became publicly available in July 2019. This ISO document is intended as a guide for the practical application of estimating uncertainty in measurement (measurement uncertainty) in a medical laboratory. In some respects, the guide does indeed meet many of its stated objectives with numerous very detailed examples. Even though it is claimed that this ISO guide is based on the Evaluation of measurement data – Guide to the expression of uncertainty in measurement (GUM), JCGM 100:2008, it is with some concern that we believe several important statements and statistical procedures are incorrect, with others potentially misleading. The aim of this report is to highlight the major concerns which we have identified. In particular, we believe the following items require further comment: (1) The use of coefficient of variation and its potential for misuse requires clarification, (2) pooled variance and measurement uncertainty across changes in measuring conditions has been oversimplified and is potentially misleading, (3) uncertainty in the results of estimated glomerular filtration rate (eGFR) do not include all known uncertainties, (4) the international normalized ratio (INR) calculation is incorrect, (5) the treatment of bias uncertainty is considered problematic, (6) the rules for evaluating combined uncertainty in functional relationships are incomplete, and (7) specific concerns with some individual statements.

Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

2020 ◽  
pp. 15-22
Author(s):  
Elena Vitalievna Perminova
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Iso 15189 ◽  
Laboratory Service ◽  
Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

scholarly journals An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials

2020 ◽  
Vol 58 (3) ◽  
pp. 368-374 ◽  
Author(s):  
Uliana Danilenko ◽  
Hubert W. Vesper ◽  
Gary L. Myers ◽  
Patric A. Clapshaw ◽  
Johanna E. Camara ◽  
...  
Keyword(s):  
Human Serum ◽  
Reference Materials ◽  
Frozen Storage ◽  
Metrological Traceability ◽  
Medical Laboratory ◽  
Serum Samples ◽  
Long Term Stability ◽  
Individual Human

AbstractManufacturers of in vitro diagnostic medical devices, clinical laboratories, research laboratories and calibration laboratories require commutable reference materials that can be used in the calibration hierarchies of medical laboratory measurement procedures used for human specimens to establish metrological traceability to higher order reference systems. Commutable materials are also useful in external quality assessment surveys. In order to achieve these goals, matrix-based reference materials with long-term stability, appropriate measurand concentrations and commutability with individual human specimens are required. The Clinical and Laboratory Standards Institute (CLSI) guideline C37-A (now archived) provided guidance to prepare commutable pooled serum reference materials for use in the calibration hierarchies of cholesterol measurement procedures. Experience using the C37-A guideline has identified a number of technical enhancements as well as applications to measurands other than cholesterol. This experience is incorporated into this updated protocol to ensure the procedure will continue to meet the needs of the medical laboratory. The updated protocol describes a procedure for preparing frozen human serum units or pools with minimal matrix alterations that are likely to be commutable with individual human serum samples. The protocol provides step-by-step guidance for the planning phase, collection of individual serum units, processing the units, qualifying the units for use in a pool and frozen storage of aliquots of pooled sera to manufacture frozen serum pools. Guidance on how to perform quality control of the final product and suggestions on documentation are also provided.

Towards a Comprehensive Knowledge Management Improvement Model for Medical Laboratories

2019 ◽  
Vol 18 (02) ◽  
pp. 1950024
Author(s):  
Lamiae Bentaleb ◽  
Saâd El Kabbaj ◽  
Mimoun Zouhdi
Keyword(s):  
Knowledge Management ◽  
Continuous Improvement ◽  
Medical Laboratory ◽  
Decision Making Process ◽  
Medical Laboratories ◽  
Comprehensive Knowledge ◽  
Analysis Laboratory ◽  
Medical Laboratory Professionals ◽  
Medical Analysis

Medical laboratories are complex facilities in which managing knowledge could impact patients’ lives. This paper presents a comprehensive and phased framework for knowledge management (KM) developed and applied within the Research and Medical Analysis Laboratory of the Gendarmerie Royale in Morocco. The model is built according to the PDCA wheel, and the four pillars of methodology are: leadership, knowledge core process, performance evaluation, and finally elements for its continuous improvement. This KM framework will help identify the knowledge needs and expectations of the medical laboratory’s relevant interested parties, support medical laboratory professionals with the decision-making process, and therefore enhance the quality of the services they provide.

scholarly journals The internal quality control in the traceability era

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Federica Braga ◽  
Sara Pasqualetti ◽  
Elena Aloisio ◽  
Mauro Panteghini
Keyword(s):  
Quality Control ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Clinical Samples ◽  
Test Results ◽  
Clinical Validity ◽  
Measuring Systems ◽  
Medical Laboratories ◽  
Laboratory Results

AbstractTo be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty (MU) as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators. Medical laboratories should know and verify how manufacturers have implemented the traceability of their calibrators and estimate the corresponding MU on clinical samples. Accordingly, the internal quality control (IQC) program should be redesigned to permit IVD traceability surveillance through the verification by medical laboratories that control materials, provided by the manufacturer as a part of measuring systems, are in the clinically suitable validation range (IQC component I). Separately, laboratories should also monitor the reliability of employed IVD measuring systems through the IQC component II, devoted to estimation of MU due to random effects and to obtaining MU of provided results, in order to apply prompt corrective actions if the performance is worsening when compared to appropriate analytical specifications, thus jeopardizing the clinical validity of test results.

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.

An Integrated Fuzzy VIKOR Method for Performance Management in Healthcare

2017 ◽  
pp. 40-61 ◽  
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu
Keyword(s):  
Performance Management ◽  
Evaluation Method ◽  
Multiple Criteria Decision Making ◽  
Poor Quality ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Standard Iso 15189

Poor quality control has become a major threat to medical laboratory services, especially in the developing countries. It has become necessary to assess and rank the quality of diagnostic services in medical laboratories using systematic approaches. The main aim of this research is to develop and apply a quantitative method in ranking medical laboratory services. This method is based on a combination of Vlsekriterijumska Optimizacija I Kompromisno Resenje (VIKOR) with fuzzy set theory. VIKOR is a multiple criteria decision making technique which focuses on ranking and selection from a set of alternatives, and determines the compromise solution for a problem with different criteria. This approach aids decision makers to achieve the most acceptable decision amidst numerous alternatives. In the present evaluation method, international standard ISO 15189 (Medical Laboratories Particular Requirements for Quality and Competence) proposed by International Organization for Standardization (ISO) is used as a fundamental source of selected attributes of a medical laboratory. The study compares three medical laboratories to each other and ranks them. This study will be a valuable and effective contribution in enhancing both qualitative and quantitative criteria in the field of medical laboratory services. Finally, some directions for further studies are proposed.

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.

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