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Traceability in Laboratory Medicine: What is it and Why is it Important for Patients?



The between method variability of patient results is a source of uncertainty that can have adverse consequences for patient safety and clinical outcomes. Globalisation requires that laboratory medicine results should be transferable between methods. Traceability in laboratory medicine aims to reduce between method variability so that results are independent of time or location. Application of the metrological traceability chain facilitates a universal approach based around the preparation, adoption and use of higher order international commutable reference materials and reference measurement procedures, supported by expert reference laboratories. Global collaboration is required, involving several different stakeholder groups ranging from international experts to laboratory medicine specialists in routine clinical laboratories.
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Traceability in laboratory medicine: what is it
and why is it important for patients?
Graham H. Beastall1,2
1 University of Glasgow, Mayeld, Birdston, Glasgow, United Kingdom
2 The Joint Commiee for Traceability in Laboratory Medicine (JCTLM)
The between method variability of paent results is
a source of uncertainty that can have adverse con-
sequences for paent safety and clinical outcomes.
Globalisaon requires that laboratory medicine results
should be transferable between methods. Traceability
in laboratory medicine aims to reduce between meth-
od variability so that results are independent of me
or locaon. Applicaon of the metrological traceability
chain facilitates a universal approach based around the
preparaon, adopon and use of higher order interna-
onal commutable reference materials and reference
measurement procedures, supported by expert ref-
erence laboratories. Global collaboraon is required,
involving several dierent stakeholder groups ranging
from internaonal experts to laboratory medicine spe-
cialists in roune clinical laboratories.
Corresponding author:
Graham H. Beastall
University of Glasgow
Mayeld, Birdston
Glasgow G66 1RW
United Kingdom
Key words:
metrological traceability,
commutability, stakeholder acon plan
Published on behalf of the Joint Commiee
for Traceability in Laboratory Medicine (JCTLM)
Page 243
Graham H. Beastall
Traceability in laboratory medicine: what is it and why is it important for paents?
Laboratory medicine results inuence a high per-
centage of all clinical decisions. Paents expect
that dierent laboratories, using dierent meth-
ods, will give the same result for an analyte mea-
sured in a clinical sample. Oen this is not the
case and an inappropriate clinical decision for
a paent may be the consequence. Laboratory
medicine specialists have a professional respon-
sibility to provide a high-quality service that is
opmised to the needs of the paent [1].
Traceability in laboratory medicine aims to re-
duce between method variability so that results
are independent of me or locaon [2]. Achieving
traceability is a global mul-stakeholder coop-
erave acvity involving metrologists; interna-
tional standards organisations; scientific and
clinical experts from internaonal professional
bodies; healthcare regulators; and the in-vitro
diagnoscs (IVD) industry that is responsible for
the manufacture and sale of diagnosc tesng
systems [3]. The Joint Commiee for Traceability
in Laboratory Medicine (JCTLM) was established
to co-ordinate the acvity of these stakeholders,
to provide educaonal support for traceability,
and to establish and maintain a database of ref-
erence materials, reference methods and refer-
ence laboratories [4].
There are several reasons why efforts should
be made to reduce between-method and be-
tween-laboratory variability [5]. These include:
Improving paent safety
Facilitang paent empowerment
Ensuring public condence
Enabling consolidaon and networking
Supporng laboratory accreditaon
Implemenng evidence-based clinical
Guaranteeing clinical governance
Adopng common informacs
Introducing the electronic paent record
Metrology is the science of measurement. The
basics of measurement involve:
A measurable property, known as a quanty
(e.g. concentraon)
Denion of the measurand the quanty
that is intended to be measured. The de-
scription of the measurand should include
the matrix (e.g. plasma); the component
(analyte) of interest, and the amount of
substance concentraon
The units in which the measurement will be
made. Metrological traceability requires the
international system of units (SI) or units
with well-established conversions
The uncertainty with which the measure-
ment can be made
Metrological traceability is the property of a
measurement result, which can be related to
a reference through a documented unbroken
chain of calibrations. The principles of a ref-
erence measurement system for establishing
metrological traceability are described in the
ISO17511:2003 document [6]. The components
of a reference measurement system comprise
reference materials (calibrators) and measure-
ment procedures (methods), both of which ex-
ist at dierent hierarchical levels.
The inter-relaonship between the components
of a reference measurement system describes
the metrological traceability chain [6]. Figure 1
depicts this traceability chain with higher order
Page 244
Graham H. Beastall
Traceability in laboratory medicine: what is it and why is it important for paents?
reference materials and measurement proce-
dures at the top and lower order towards the
bottom. This hierarchy is depicted by the ris-
ing ‘metrological traceability’ arrow. Descent
through the traceability chain is accompanied
by increasing measurement uncertainty as de-
picted by the downward arrow.
The traceability status of an individual measure-
ment result depends on the existence of an un-
broken chain to higher order materials and/or
measurement procedures. To be eecve the
unbroken chain requires commutable materials
[7] and suciently low imprecision at each step.
In the case of structurally simple molecules,
like many of those measured rounely in clini-
cal chemistry, it is possible to have a complete
unbroken chain to primary reference measure-
ment procedures and primary reference materi-
als. Even for some protein molecules it is possible
to achieve full metrological traceability by using
a unique, signature pepde as the primary refer-
ence material. The measurement of serum cho-
lesterol and blood haemoglobin A1c are examples
of full metrological traceability where the agree-
ment between methods is excellent [3]. Serum
parathyroid hormone and blood haemoglobin A2
are examples where the between-method vari-
ability is unacceptably high, causing clinical risk.
In both these cases method standardisaon/har-
monisaon iniaves have commenced [3].
For many biological materials, including com-
plex proteins and viruses it is not possible to
prepare secondary calibrators. In these circum-
stances internaonal convenonal calibrators
are adopted as being the highest order materi-
als available. The global acceptance of such in-
ternaonal convenonal calibrators can facili-
tate reduced between method variability.
Figure 1 Metrological traceability chain for laboratory medicine
Primary reference material
Primary calibrator
Secondary calibrator
Manufacturer master
Product calibrator
Patient result
Primary reference
measurement procedure
Secondary reference
measurement procedure
Manufacturer selected
measurement procedure
Manufacturer standing
measurement procedure
Routine laboratory method
Metrological traceability
IVD method
institute /
Reference lab
Measurement uncertainty
Adapted from EN ISO 17511 2003 [6]
Definition of measurand: concentration in SI units
Page 245
Graham H. Beastall
Traceability in laboratory medicine: what is it and why is it important for paents?
The JCTLM maintains a database of refer-
ence materials, reference measurement pro-
cedures and reference laboratories [8]. Strict
criteria are required for inclusion in the JCTLM
database, including evidence of commutabil-
ity of reference materials and measurement
The World Health Organizaon Expert Commiee
for Biological Standardizaon (WHO-ECBS) main-
tains a catalogue of internaonal convenonal
calibrators for blood products and biological
stan dards [9].
There are several challenges to implemenng
global traceability [3]. These include:
Geographical dierences
Lack of uniformity of units
Complex analytes
Global coordinaon
The stakeholders involved in delivering trace-
ability in laboratory medicine into roune prac-
ce are summarised in Figure 2.
Figure 2 Global stakeholders involved in delivering traceability
in laboratory medicine into routine practice
Define clinical decision values
and analytical requirements
Provide reference materials
and reference methods
List available materials and
methods. Promote traceability
Raise analytical and clinical
quality targets
Produce higher-order methods
with commutable calibrators
Use commutable materials to
monitor method performance
Select methods based on
quality performance
IVD method
Standards / accreditation /
professional bodies
Global database of reference
materials & methods
National metrology institutes
Professional bodies / societies
Internationally recognised expert
clinical / laboratory committees
Adapted from Beastall et al. [3]
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Graham H. Beastall
Traceability in laboratory medicine: what is it and why is it important for paents?
The iniave begins at the boom of the trian-
gle with internaonal recognion of the need
for traceability for a specic analyte. Thereaer,
internaonal and naonal standards organisa-
ons and metrology instutes are responsible
for producing and lisng the available reference
materials and measurement procedures. These
are used by the IVD method manufacturers to
produce the methods made available for roune
use with their performance evaluated through
external quality assessment (EQA) schemes
based on commutable control materials.
The implementaon of traceability in laboratory
medicine at a global level requires a coordinated
action plan. This can be derived from Figure 2
by assigning acons to each of the seven stake-
holder groups [3].
1. Internaonally recognised expert clinical/
laboratory commiees:
Develop internaonal consorum for
communicaon and sharing informa-
on on the need for traceability
Priorise and agree methods that re-
quire harmonisaon and issue invita-
ons to expert groups to undertake
method harmonisaon projects [10]
2. Naonal metrology instutes/internaonal
professional bodies/sociees:
Develop commutable reference materi-
als and measurement procedures for
individual analytes to the highest avail-
able order of metrological traceability
Publish the outcome of harmonisaon
projects in peer-reviewed scienc
3. Global database of reference materials and
Using freely available lists and cata-
logues publicise available reference
materials and methods that meet
agreed standards, including informaon
on commutability and measurement
Provide educaonal support materials
to promote the importance of trace-
ability in laboratory medicine
4. Standards/accreditaon/professional bodies:
Include traceability in laboratory medi-
cine in the training of laboratory medi-
cine specialists and in the standards
required for laboratory accreditaon
Provide educaonal support materials
to promote the importance of trace-
ability in laboratory medicine
5. IVD method manufacturers:
Produce IVD methods that conform
with the highest available order of met-
rological traceability
Provide details of the traceability status
of methods in the informaon for use
6. EQA providers:
Promote the use of commutable EQA
Provide educaonal support about
traceability for EQA scheme parcipants
7. Roune laboratory medicine specialists:
Know the traceability status of the
methods used and understand the
measurement uncertainty involved
Educate sta about traceability in labo-
ratory medicine and its importance to
Page 247
Graham H. Beastall
Traceability in laboratory medicine: what is it and why is it important for paents?
Resources for educaonal support are available
from JCTLM [4]. Readers of this arcle are invited
to discuss with their peers how they can contrib-
ute to the coordinated acon plan.
1. Beastall GH. Adding value to laboratory medicine: a
professional responsibility. Clin Chem Lab Med 2013; 51:
2. White GH. Metrological traceability in clinical biochem-
istry. Ann Clin Biochem 2011; 48: 393-409
3. Beastall GH, Brouwer N, Quiroga S, Myers GL. Trace-
ability in laboratory medicine: a global driver for accurate
results for paent care. Clin Chem Lab Med 2017; 55:
4. JCTLM: Traceability, educaon and promoon. www. (accessed 25 July 2018)
5. Plebani M. Harmonizaon in laboratory medicine: the
complete picture. Clin Chem Lab Med 2013; 51: 741-751
6. ISO 17511: 2003 In vitro diagnosc medical devices -
measurement of quanes in biological samples – met-
rological traceability of values assigned to calibrators and
control materials ISO, Geneva, Switzerland; 2003
7. Young IS. The enduring importance and challenge of
commutability. Clin Chem 2018; 64: 421-423
8. JCTLM database of reference materials and measure-
ment procedures (accessed 25 July
9. WHO catalogue of blood products and related biologi-
(accessed 25 July 2018)
10. The Internaonal Consorum for Harmonizaon of
Clinical Laboratory Results. www.harmoniza (ac-
cessed 25 July 2018)
... Nghiên cứu hồi cứu. Kết quả: Có sự khác nhau có ý nghĩa thống kê (p < 0,05) 1 Đại học Y Dược Thành phố Hồ Chí Minh 2 Bệnh viện Đại học Y Dược Tp. Hồ Chí Minh cơ sở 2 Chịu trách nhiệm chính: Văn Hy Triết Email: ...
... Trong khi đó, các quyết định lâm sàng phần lớn phụ thuộc vào kết quả xét nghiệm. Đồng thời, người bệnh mong muốn rằng các phòng xét nghiệm (PXN) khác nhau, sử dụng các phương pháp khác nhau sẽ đưa ra kết quả giống nhau [1]. ...
Đặt vấn đề: Xét nghiệm dấu ấn ung thư ngày càng quan trọng trong việc chẩn đoán sớm và quản lý ung thư. Tuy nhiên, một chất được xét nghiệm bằng các phương pháp hoặc thiết bị khác nhau sẽ cho kết quả khác nhau. Trong khi đó, các quyết định lâm sàng phần lớn phụ thuộc vào kết quả xét nghiệm và người bệnh mong muốn rằng các phòng xét nghiệm (PXN) khác nhau, sử dụng các phương pháp khác nhau sẽ đưa ra kết quả giống nhau. Do đó, chuẩn hóa và liên thông kết quả xét nghiệm là vấn đề cần thiết hiện nay để giảm thiểu sự khác nhau giữa các phương pháp, tạo điều kiện để các PXN công nhận kết quả của nhau và thống nhất việc áp dụng các hướng dẫn thực hành trên lâm sàng tốt; đảm bảo tính an toàn cho bệnh nhân và giảm chi phí chăm sóc y tế. Mục tiêu nghiên cứu: xây dựng cơ sở dữ liệu cho việc liên thông xét nghiệm dấu ấn ung thư: carcinoembryonic antigen (CEA), cancer antigen 19-9 (CA 19-9), prostate specific antigen (PSA). Đối tượng và phương pháp nghiên cứu: Các báo cáo kết quả ngoại kiểm xét nghiệm CEA, CA 19-9, PSA từ chương trình ngoại kiểm RIQAS được thu thập tại bệnh viện Đại học Y dược TPHCM cơ sở 2 từ năm 2018 đến năm 2021. Nghiên cứu hồi cứu. Kết quả: Có sự khác nhau có ý nghĩa thống kê (p < 0,05) về nồng độ và độ chệch giữa các phương pháp tham gia. CA 19-9 là xét nghiệm có độ chệch lớn nhất và sự đồng thuận kém nhất (CV > 40%). Các xét nghiệm CEA và PSA có độ chệch thấp hơn, sự đồng thuận tốt hơn (CV trung bình lần lượt là 11,85% và 16,55%) và đa số từng phương pháp có CV < 10%. Tuy nhiên sự đồng thuận của ba xét nghiệm dấu ấn ung thư này có xu hướng được cải thiện từ năm 2018 đến năm 2021, nhất là xét nghiệm CA 19-9. Kết luận: Cả ba xét nghiệm dấu ấn ung thư đều có sự khác nhau giữa các phương pháp, nhất là CA 19-9. Xét nghiệm CA 19-9 và CEA cần thiết phải được chuẩn hóa và xét nghiệm PSA phải thực hiện liên thông để giảm thiểu sự khác nhau giữa các phương pháp.
... Despite these developments, individual methods may exhibit limitations, including laborious sample preparation (e.g., solid phase extraction) [6,15], limited calibration range, and high method variability (inter-and intra-day precisions) [4,6,22,23]. In addition, the traceability of clinical laboratory measurements is fundamental to ensure that results of such methods are comparable between laboratories and to reduce between-method variability [24,25]. A lack of traceability and standardization arguably poses a risk for patients, since it can lead to misinterpretation if results are compared with reference ranges or therapeutic ranges that have been established with other methods [26]. ...
... A strength of the method described was using qNMRa method that is increasingly acceptable to NMIsto determine the absolute content of MTX in the standard and enable unequivocal traceability to SI units [25]. Aside from exhibiting a performance suitable for an RMP, the traceability of the current method is a key distinguishing feature and is pivotal in determining the absolute quantity of a measurand [24,25]. In summary, the described candidate RMP is suitable for TDM and also for assigning target values to secondary reference materials to aid in assay standardization (e.g., in the in vitro diagnostics industry). ...
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Objectives To develop an isotope dilution-liquid chromatography-tandem mass spectrometry-(ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for quantification of methotrexate in human serum and plasma. Methods Quantitative nuclear magnetic resonance (qNMR) was used to determine absolute methotrexate content in the standard. Separation was achieved on a biphenyl reversed-phase analytical column with mobile phases based on water and acetonitrile, both containing 0.1% formic acid. Sample preparation included protein precipitation in combination with high sample dilution, and method validation according to current guidelines. The following were assessed: selectivity (using analyte-spiked samples, and relevant structural-related compounds and interferences); specificity and matrix effects (via post-column infusion and comparison of human matrix vs. neat samples); precision and accuracy (in a five-day validation analysis). RMP results were compared between two independent laboratories. Measurement uncertainty was evaluated according to current guidelines. Results The RMP separated methotrexate from potentially interfering compounds and enabled measurement over a calibration range of 7.200–5,700 ng/mL (0.01584–12.54 μmol/L), with no evidence of matrix effects. All pre-defined acceptance criteria were met; intermediate precision was ≤4.3% and repeatability 1.5–2.1% for all analyte concentrations. Bias was −3.0 to 2.1% for samples within the measuring range and 0.8–4.5% for diluted samples, independent of the sample matrix. RMP results equivalence was demonstrated between two independent laboratories (Pearson correlation coefficient 0.997). Expanded measurement uncertainty of target value-assigned samples was ≤3.4%. Conclusions This ID-LC-MS/MS-based approach provides a candidate RMP for methotrexate quantification. Traceability of methotrexate standard and the LC-MS/MS platform were assured by qNMR assessment and extensive method validation.
... El propósito de una prueba de laboratorio médico es proporcionar información sobre la condición fisiopatológica de un paciente que ayuda el diagnóstico, la terapia o la evaluación del riesgo de una enfermedad (1) , esto es problemático cuando las mediciones de una prueba son diferentes según el laboratorio donde se realizan los análisis, lo que puede dar lugar a una evaluación inexacta o inconsistente o, en el peor de los casos, a una intervención o un procedimiento inadecuado o la falta del mismo, además de una sobreutilización del recurso de repeticiones debido a información discrepante (2) . Para un servicio de laboratorio óptimo, los resultados de diferentes procedimientos de medición (PM) para el mismo mensurando deben ser equivalentes (armonizados) entre métodos dentro de las especificaciones establecidas lo que, permita que los resultados se utilicen de manera confiable para decisiones médicas y para reducir el riesgo de una interpretación errónea de los resultados de las pruebas (1,3) . ...
... Esta organización, mantiene una base de datos de materiales de referencia, procedimientos de medición de referencia y laboratorios de referencia, que requieren criterios estrictos para su inclusión que incluye la evidencia de la conmutabilidad de los MR y la incertidumbre de la medición (3) . ...
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Equivalence of results issued by clinical laboratories can be achieved by standardization or harmonization. The generation of comparable results allows common reference intervals between laboratories using different measurement procedures and materials for calibration and trueness control. The aim of this article is to describe the state of the art of metrological traceability in laboratory medicine, currently highlighted through the guidelines of ISO 17511, which in its 2020 version, shows six different hierarchical alternatives, ranging from comparability to certified reference materials and reference measurement procedures, to traceability only to the manufacturer. This new version of 17511 adds the possibility to demonstrate traceability to international harmonization protocols. Demonstrating metrological traceability is required to achieve ISO 15189 accreditation for clinical laboratories. To achieve equivalence of measurements in laboratory medicine, it is desirable to bring clinical laboratory professionals closer to the metrological language and the stakeholders involved.
... As patients and clinicians expect equivalent results for similar tests among hospitals, metrological traceability of test results is essential. Implementation of innovations such as mass spectrometry (MS) technology for protein quantitation (1) and novel metrological insights, based on International Organization for Standardization (ISO) 17511:2020, are key to ensure accurate test results at a global level (2). It is therefore imperative that RMS for emerging measurands are developed and that already existing RMS are improved when needed. ...
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Background: Medical results generated by European CE Marking for In Vitro Diagnostic or in-house tests should be traceable to higher order reference measurement systems (RMS), such as International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)-endorsed reference measurement procedures (RMPs) and reference materials. Currently, serum apolipoprotein (a) [apo(a)] is recognized as a novel risk factor for cardiovascular risk assessment and patient management. The former RMS for serum apo(a) is no longer available; consequently, an International System of Units (SI)-traceable, ideally multiplexed, and sustainable RMS for apo(a) is needed. Methods: A mass spectrometry (MS)-based candidate RMP (cRMP) for apo(a) was developed using quantitative bottom-up proteomics targeting 3 proteotypic peptides. The method was provisionally validated according to ISO 15193 using a single human serum based calibrator traceable to the former WHO-IFCC RMS. Results: The quantitation of serum apo(a) was by design independent of its size polymorphism, was linear from 3.8 to 456 nmol/L, and had a lower limit of quantitation for apo(a) of 3.8 nmol/L using peptide LFLEPTQADIALLK. Interpeptide agreement showed Pearson Rs of 0.987 and 0.984 for peptides GISSTVTGR and TPENYPNAGLTR, and method comparison indicated good correspondence (slopes 0.977, 1.033, and 1.085 for LFLEPTQADIALLK, GISSTVTGR, and TPENYPNAGLTR). Average within-laboratory imprecision of the cRMP was 8.9%, 11.9%, and 12.8% for the 3 peptides. Conclusions: A robust, antibody-independent, MS-based cRMP was developed as higher order RMP and an essential part of the apo(a) traceability chain and future RMS. The cRMP fulfils predefined analytical performance specifications, making it a promising RMP candidate in an SI-traceable MS-based RMS for apo(a).
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Zbog rastuće svesti o neophodnosti zaštite životne sredine, dolazi do promena u svim sferama ljudskog života, pa tako i u sferi rada i poslovanja. Postojeće kompanije uvode društveno odgovorne aspekte u svoje poslovne procese, a razvijaju se i nove, zelene kompanije koje posvećuju posebnu pažnju proizvodnji ekoloških proizvoda koji nanose najmanje štete životnoj sredini. Kontakt između zelenih kompanija i zelenih potrošača odvija se, u najvećoj meri, na internetu i to uglavnom putem društvenih mreža koje su omogućile kreativnu, neformalnu i informativnu komunikaciju. Ono što je zelenim potrošačima važno, jeste da se informišu o karakteristikama zelenih proizvoda, ali i da drugima pokažu svoju ekološku svest, a u cilju podsticanja drugih da se društveno odgovorno ponašaju. Zeleni potrošači to čine putem društvenih mreža deleći sadržaje, slike, iskustva o zelenim kompanijama i proizvodima, što povećava vidljivost samih kompanija, poboljšava njihovu reputaciju, ali i utiče na povećanje broja budućih društveno odgovornih potrošača. Ključne reči: zelene kompanije, zeleni potrošači, društvene mreže, poslovanje, konkurentnost
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Las mediciones confiables, trazables metrológicamente y comparables proporcionan la base racional para la evaluación de la calidad de un resultado y el fortalecimiento de las redes de laboratorios clínicos, lo cual permite mejorar la calidad de atención y la seguridad del paciente. En este documento se revisan los principios básicos que deben seguirse para garantizar la trazabilidad de las mediciones del laboratorio clínico, las ventajas de utilizar métodos trazables, el impacto de no hacerlo, y se discuten las principales limitaciones para relacionar las mediciones con los estándares de medición de referencia apropiados.
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Abstract 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 three-tier 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).
Laboratory 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 HbA1c serve 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.
Abstract 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: standardisation 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.
True and precise routine measurements of quantities of clinical interest are essential if results are to be optimally interpreted for patient care. Additionally, results produced by different measurement procedures for the same measurand must be comparable if common diagnostic decision values and clinical research findings are to be broadly applied. Metrology, the science of measurement, provides laboratory medicine with a structured approach to the development and terminology of reference measurement systems which, when implemented, improve the accuracy and comparability of patients' results. The metrological approach is underpinned by the concepts of common measurement units, traceability of measured values, measurement uncertainty and commutability. Where traceability to the International System of Units (SI units) is not yet realized for a measurand, result comparability may be achievable by other, less ideal, approaches. Measurements are the core activity of clinical laboratories, and clinical biochemists should ensure that patients' results are traceable to the highest available reference. This review introduces and illustrates the principles of metrological traceability, describes its critical importance to improving the quality of patients' results and highlights the need to actively promote traceability in clinical laboratories.
In vitro diagnostic medical devicesmeasurement of quantities in biological samples -metrological traceability of values assigned to calibrators and control materials ISO
  • M Plebani
Plebani M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013; 51: 741-751 6. ISO 17511: 2003 In vitro diagnostic medical devicesmeasurement of quantities in biological samples -metrological traceability of values assigned to calibrators and control materials ISO, Geneva, Switzerland; 2003