Translation: Roadmap for Harmonization of Clinical Laboratory Measurement Procedures

Miller, W. Greg; Myers, Gary L.; Gantzer, Mary Lou; Kahn, Stephen E.; Schönbrunner, E. Ralf; Thienpont, Linda M.; Bunk, David M.; Christenson, Robert H.; Eckfeldt, John H.; Lo, Stanley F.; Nübling, C. Micha; Sturgeon, Catharine M.

doi:10.3343/lmo.2012.2.1.1

Cited by 22 publications

(27 citation statements)

References 31 publications

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“…First, the processes required to achieve harmonization are complicated and therefore an infrastructure with ' well-defined procedures, transparent operation, effective communication with all stakeholders, and a consensus approach to cooperation ' is mandatory [ 18 ]. The systematic approach and roadmap proposed by Miller and colleagues as a result of the conference organized in 2010 by the AACC represent an essential step towards successful harmonization initiatives in laboratory medicine.…”

Section: The Agenda For Harmonizationmentioning

confidence: 99%

“…The systematic approach and roadmap proposed by Miller and colleagues as a result of the conference organized in 2010 by the AACC represent an essential step towards successful harmonization initiatives in laboratory medicine. Underpinning this systematic approach is the recognition that it is important to ' identify measurands for which harmonization is needed, prioritize the measurands based on clinical importance and technical feasibility, and organize the implementation of harmonization initiatives ' [ 18 ].…”

Section: The Agenda For Harmonizationmentioning

confidence: 99%

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Harmonization in laboratory medicine: the complete picture

Plebani

2013

Clinical Chemistry and Laboratory Medicine (CCLM)

133

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Evidence of the acute lack of interchangeable laboratory results and consensus in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus is mainly on the standardization of measurement procedures, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference intervals and decision limits, as well as test profiles and criteria for the interpretation of results. This review provides further insight on the issue of harmonization in laboratory medicine in view of the urgent need for a complete picture now that old and new drivers are calling for more effective efforts in this field. The main drivers for standardization and harmonization projects are first and foremost patient safety, but also the increasing trends towards consolidation and networking of clinical laboratories, accreditation programs, clinical governance, and advances in Information Technology (IT), including the electronic patient record. The harmonization process, which should be considered a threetier approach involving local, national and international fronts, must go beyond the harmonization of methods and analytical results to include all other aspects of laboratory testing. A pertinent example of the importance of a complete picture in harmonization programs is given by the National Bone Health Alliance working in the field of bone turnover markers in cooperation with scientific societies including the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

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Section: The Agenda For Harmonizationmentioning

confidence: 99%

Section: The Agenda For Harmonizationmentioning

confidence: 99%

Harmonization in laboratory medicine: the complete picture

Plebani

2013

Clinical Chemistry and Laboratory Medicine (CCLM)

133

View full text Add to dashboard Cite

show abstract

“…Sometimes, neither a CRM nor a reference method is available [19,20], making a case for a reference that has a value assigned to it by agreement [20].…”

Section: The Concepts Of Bias and Imprecisionmentioning

confidence: 99%

The use of error and uncertainty methods in the medical laboratory

Oosterhuis

Bayat²,

Armbruster

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Error methods -compared with uncertainty methods -offer simpler, more intuitive and practical procedures for calculating measurement uncertainty and conducting quality assurance in laboratory medicine. However, uncertainty methods are preferred in other fields of science as reflected by the guide to the expression of uncertainty in measurement. When laboratory results are used for supporting medical diagnoses, the total uncertainty consists only partially of analytical variation. Biological variation, pre-and postanalytical variation all need to be included. Furthermore, all components of the measuring procedure need to be taken into account. Performance specifications for diagnostic tests should include the diagnostic uncertainty of the entire testing process. Uncertainty methods may be particularly useful for this purpose but have yet to show their strength in laboratory medicine. The purpose of this paper is to elucidate the pros and cons of error and uncertainty methods as groundwork for future consensus on their use in practical performance specifications. Error and uncertainty methods are complementary when evaluating measurement data.

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“…This has only been achieved for a relatively small number of biomarkers, which are listed by the Joint Committee for Traceability in Laboratory Medicine [16] . A new international project has been proposed to address a co-ordinated approach to the harmonisation of the many methods that cannot meet the requirements of standardisation [17] .…”

Section: Standardisation and Harmonisationmentioning

confidence: 99%

Adding value to laboratory medicine: a professional responsibility

Beastall

2012

Clinical Chemistry and Laboratory Medicine (CCLM)

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Laboratory medicine is a medical specialty at the centre of healthcare. When used optimally laboratory medicine generates knowledge that can facilitate patient safety, improve patient outcomes, shorten patient journeys and lead to more cost-effective healthcare. Optimal use of laboratory medicine relies on dynamic and authoritative leadership outside as well as inside the laboratory. The first responsibility of the head of a clinical laboratory is to ensure the provision of a high quality service across a wide range of parameters culminating in laboratory accreditation against an international standard, such as ISO 15189. From that essential baseline the leadership of laboratory medicine at local, national and international level needs to ' add value ' to ensure the optimal delivery, use, development and evaluation of the services provided for individuals and for groups of patients. A convenient tool to illustrate added value is use of the mnemonic ' SCIENCE ' . This tool allows added value to be considered in seven domains: standar disation and harmonisation; clinical effectiveness; innovation; evidence-based practice; novel applications; cost-effectiveness; and education of others. The assessment of added value in laboratory medicine may be considered against a framework that comprises three dimensions: operational efficiency; patient management; and patient behaviours. The profession and the patient will benefit from sharing examples of adding value to laboratory medicine.

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Translation: Roadmap for Harmonization of Clinical Laboratory Measurement Procedures

Cited by 22 publications

References 31 publications

Harmonization in laboratory medicine: the complete picture

Harmonization in laboratory medicine: the complete picture

The use of error and uncertainty methods in the medical laboratory

Adding value to laboratory medicine: a professional responsibility

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