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 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.

Harmonization and Standardization: Where Are We Now?

2020 ◽  
Author(s):  
W Greg Miller ◽  
Neil Greenberg
Keyword(s):  
Reference Materials ◽  
Certified Reference Materials ◽  
Metrological Traceability ◽  
Medical Laboratory ◽  
Clinical Samples ◽  
End User ◽  
Laboratory Service ◽  
Fit For Purpose ◽  
Diagnosis Therapy ◽  
Traceable Calibration

Abstract Background The purpose of a medical laboratory test is to provide information on the pathophysiologic condition of an individual patient as an aid in diagnosis, therapy, or assessment of risk for a disease. For optimal laboratory service, results from different measurement procedures (MPs) for the same measurand should be equivalent (harmonized) within stated specifications, enabling the results to be used reliably for medical decisions. The term “harmonization” refers to any process that enables establishing equivalence of reported values among different end-user MPs. The term “standardization” refers to achieving harmonization by metrological traceability of patients’ results to higher order reference materials and/or reference measurement procedures. Content New procedures for harmonization and standardization were published in 2020 by the International Organization for Standardization (ISO) and by the IFCC. ISO 17511:2020 provides revised requirements for establishing metrologically traceable calibration hierarchies for end-user MPs used in clinical laboratories. ISO 21151:2020 provides new requirements to implement a harmonization protocol to address the situation when there are no fit-for-purpose certified reference materials or reference MPs available for a measurand. The IFCC Working Group on Commutability published recommendations for applying a correction for noncommutability of a certified reference material to enable using that material in a metrologically traceable calibration hierarchy for an end-user MP. Summary We review metrological traceability and how these new approaches will improve the capability to achieve harmonized results for clinical samples.

scholarly journals IFCC Working Group Recommendations for Correction of Bias Caused by Noncommutability of a Certified Reference Material Used in the Calibration Hierarchy of an End-User Measurement Procedure

2020 ◽  
Vol 66 (6) ◽  
pp. 769-778 ◽  
Author(s):  
W Greg Miller ◽  
Jeffrey Budd ◽  
Neil Greenberg ◽  
Cas Weykamp ◽  
Harald Althaus ◽  
...  
Keyword(s):  
Reference Material ◽  
Certified Reference Material ◽  
Clinical Laboratory ◽  
Metrological Traceability ◽  
Measurement Procedure ◽  
Clinical Samples ◽  
End User ◽  
Assigned Value ◽  
The Difference ◽  
Specific Correction

Abstract Establishing metrological traceability to an assigned value of a matrix-based certified reference material (CRM) that has been validated to be commutable among available end-user measurement procedures (MPs) is central to producing equivalent results for the measurand in clinical samples (CSs) irrespective of the clinical laboratory MPs used. When a CRM is not commutable with CSs, the bias due to noncommutability will be propagated to the CS results causing incorrect metrological traceability to the CRM and nonequivalent CS results among different MPs. In a commutability assessment, a conclusion that a CRM is commutable or noncommutable for use with a specific MP is made when the difference in bias between the CRM and CSs meets or does not meet a criterion for that specific MP when compared to other MPs. A conclusion regarding commutability or noncommutability requires that the magnitude of the difference in bias observed in the commutability assessment remains unchanged over time. This conclusion requires the CRM to be stable and no substantive changes in the MPs. These conditions should be periodically reverified. If an available CRM is determined to be noncommutable for a specific MP, that CRM can be used in the calibration hierarchy for that MP when an appropriately validated MP-specific correction for the noncommutability bias is included. We describe with examples how a MP-specific correction and its uncertainty can be developed and applied in a calibration hierarchy to achieve metrological traceability of results for CSs to the CRM’s assigned value.

Quality management in medical laboratories

2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres
Keyword(s):  
Quality Management ◽  
Medical Laboratory ◽  
Management Systems ◽  
The European Union ◽  
Quality Management Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Systems Quality ◽  
Standard Iso 15189

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

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 Status of Development and Implementation of Medical Laboratories Accreditation in Serbia

2008 ◽  
Vol 27 (2) ◽  
pp. 144-147
Author(s):  
Ljubinka Gligić
Keyword(s):  
Accreditation Process ◽  
Laboratory Accreditation ◽  
European Countries ◽  
Medical Laboratory ◽  
External Quality Assessment Scheme ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Set Up ◽  
Definition Of

Status of Development and Implementation of Medical Laboratories Accreditation in SerbiaThrough the release of the SRPS ISO 15189:2008 standard entitled >>Medicinske laboratorije: posebni zahtevi za kvalitet i kompetentnost<< conditions have been created for medical laboratory accreditation in Serbia. The application of the ISO 15189:2007 standard is an accepted mechanism for improvement of the quality of medical laboratory services throughout EU today. In that way, different approaches to the quality improvement of medical laboratories have been harmonized. Functional organisation of the accreditation process of medical laboratories in most European countries is mainly carried out in cooperation with national accreditation bodies, medical experts appointed by scientist associations and health departments. This type of collaboration has proven successful in the United Kingdom, Germany, Hungary, France, Finland, Croatia, etc. The experiences of the Accreditation Board of Serbia (ABS) in medical laboratory accreditation according to the SRPS ISO/IEC 17025:2006 standard (5 laboratories have been accredited) and the positive experiences of European countries in accreditation process constitute the basis for the development of the program for medical laboratory accreditation in Serbia. The first step in this direction is the set-up of the Committee consisting of experts from different medical fields, ABS experts and representatives of the competent Ministry, as well as the definition of their tasks, such as: preparation of the necessary documentation, set-up and preparation of qualification criteria and training programs for assessors, participation in the development of the external quality assessment scheme through interlaboratory testing, liaison with the European organisations for accreditation, organisation of mutual assessments with national and international assessors, participation in decision making on accreditation and accreditation maintenance.

scholarly journals The pathway for introducing novel examination procedures in routine practice in accordance with ISO 15189:2012: 17-Hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D as examples

2019 ◽  
Vol 56 (5) ◽  
pp. 548-555 ◽  
Author(s):  
Giorgia Antonelli ◽  
Laura Sciacovelli ◽  
Ada Aita ◽  
Dania Bozzato ◽  
Mario Plebani
Keyword(s):  
Vitamin D ◽  
Diagnostic Testing ◽  
Metrological Traceability ◽  
Diagnostic System ◽  
Medical Laboratory ◽  
Routine Practice ◽  
Dehydroepiandrosterone Sulphate ◽  
Iso 15189 ◽  
Hydroxy Progesterone ◽  
Analytical Phase

Background In a medical laboratory, changes may be made to the analytical phase of diagnostic testing whenever a new test or the issue of a ‘new generation’ kit or new diagnostic system is required. In such cases, ISO 15189:2012 accreditation can assist laboratory professionals. The aim of the present study was to propose a working pathway for introducing new examination procedures into clinical practice in accordance with the ISO 15189:2012 standard, through the exemplars of 17-hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D. Methods The working pathway includes the following steps: (i) analysing examination procedures under evaluation, (ii) analysing examination procedures currently in use, (iii) verifying metrological traceability, (iv) verifying examination procedures and (v) evaluating comparability of results. Results The analysis of instructions for use issued by manufacturers revealed that metrological traceability was reported only for vitamin D. The imprecision verification was satisfactory, the imprecision obtained by the laboratory in terms of total imprecision always being less than the specified total imprecision. In only one case (IQC level 1, 17-hydroxy progesterone), the total upper verification limit was calculated. The trueness verification was satisfactory for all examination procedures, except for 17-hydroxy progesterone (second material). Passing–Bablok regression analyses in the comparability study demonstrated significant differences for all the examination procedures. Conclusions The working pathway described for examination procedures in routine practice is in accordance with the requirements of ISO 15189:2012 accreditation and takes feasibility into account (as its main goal), based on the cost/patient benefit ratio.

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 The new ISO and CEN standards for quality and accreditation of medical laboratories

2004 ◽  
Vol 23 (3) ◽  
pp. 305-310 ◽  
Author(s):  
Kenny Desmond
Keyword(s):  
Point Of Care ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
International Standard ◽  
Laboratory Service ◽  
Medical Laboratories ◽  
Medical Environment ◽  
Common Basis ◽  
The World ◽  
Almost All

The new international standard EN ISO 15189:2003 ?Medical laboratories - particular requirements for quality and competence?, after many delays, was finally published in February 2003. This standard has been developed specifically to address requirements for accreditation of medical laboratories. It takes into account the special constraints imposed by the medical environment and the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories provide not only testing of patient samples, but also advisory, interpretative and educational services. It also acknowledges the role of diagnostics manufacturers in maintaining the quality of medical laboratory services. The international standard ISO/IEC 17025 ?General requirements for the competence of testing and calibration laboratories? is already used in some countries for accreditation of medical laboratories. This is a standard which was developed mainly for use in industrial testing laboratories, and has serious deficiencies when used in the medical environment. While still in draft form, 15189 was already approved by ILAC (International Laboratory Accreditation Co-operation) as a suitable basis for accrediting medical laboratories. It is expected that this document will be used widely in Europe and throughout the world as the preferred standard for this purpose. An informal survey of FESCC member societies shows that 15189, alone or in combination with other standards, will be used in almost all European countries for accreditation of medical laboratories. A further complementary standard, ISO 15190 ?Medical laboratories - requirements for safety? has now been published. A standard for quality and competence in Point Of Care Testing (POCT) is under development, and will be published as a new Annex to EN ISO 15189. These standards will for the first time provide a common basis for the development of quality systems and requirements for competence in medical laboratories throughout the world.

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.

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