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

December 2018

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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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Meeng the needs of Mediterranean naons: improving eciency in laboratory medicine

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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)

ARTICLE INFO ABSTRACT

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

E-mail: gbeastall@googlemail.com

Key words:

metrological traceability,

commutability, stakeholder acon plan

Acknowledgements:

Published on behalf of the Joint Commiee

for Traceability in Laboratory Medicine (JCTLM)

eJIFCC2018Vol29No4pp242-247

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Graham H. Beastall

Traceability in laboratory medicine: what is it and why is it important for paents?

INTRODUCTION

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].

THE IMPORTANCE

OF REDUCING BETWEEN-METHOD

AND BETWEEN-LABORATORY VARIABILITY

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

guidelines

• Guaranteeing clinical governance

• Adopng common informacs

• Introducing the electronic paent record

TRACEABILITY IN LABORATORY

MEDICINE AND THE METROLOGICAL

TRACEABILITY CHAIN

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

eJIFCC2018Vol29No4pp242-247

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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

calibrator

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

Routine

lab

IVD method

manufacturer

Metrology

institute /

Reference lab

Measurement uncertainty

Adapted from EN ISO 17511 2003 [6]

Definition of measurand: concentration in SI units

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Graham H. Beastall

Traceability in laboratory medicine: what is it and why is it important for paents?

SOURCES OF REFERENCE MATERIALS

AND REFERENCE MEASUREMENT

PROCEDURES

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

uncertainty.

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].

CHALLENGES IN IMPLEMENTING

TRACEABILITY IN LABORATORY MEDICINE

AT A GLOBAL LEVEL

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

STAKEHOLDERS IN IMPLEMENTING

TRACEABILITY IN LABORATORY MEDICINE

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

Routine

lab

EQA

providers

IVD method

manufacturers

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.

ACTION PLAN TO IMPLEMENT

TRACEABILITY IN LABORATORY MEDICINE

AT A GLOBAL LEVEL

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

literature

3. Global database of reference materials and

methods:

• Using freely available lists and cata-

logues publicise available reference

materials and methods that meet

agreed standards, including informaon

on commutability and measurement

uncertainty

• 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

documentaon

6. EQA providers:

• Promote the use of commutable EQA

materials

• 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

healthcare

eJIFCC2018Vol29No4pp242-247

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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.

REFERENCES

1. Beastall GH. Adding value to laboratory medicine: a

professional responsibility. Clin Chem Lab Med 2013; 51:

221-228

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:

1100-1108

4. JCTLM: Traceability, educaon and promoon. www.

jctlm.org (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 www.bipm.org/jctlm/ (accessed 25 July

2018)

9. WHO catalogue of blood products and related biologi-

cals http://www.who.int/bloodproducts/catalogue/en

(accessed 25 July 2018)

10. The Internaonal Consorum for Harmonizaon of

Clinical Laboratory Results. www.harmonizaon.net (ac-

cessed 25 July 2018)

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Feb 2013

Mario Plebani

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).

The Enduring Importance and Challenge of Commutability

Article

Jan 2018

Ian Young

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

Article

Apr 2017
CLIN CHEM LAB MED

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.

Adding value to laboratory medicine: A professional responsibility

Article

Oct 2012

Graham Beastall

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.

Metrological traceability in clinical biochemistry

Article

Jul 2011
ANN CLIN BIOCHEM

Graham H White

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

Jan 2003
CLIN CHEM LAB MED
741-751

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

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

Abstract

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