for the development of suitable reference
methods and measurement procedures and
certified reference materials;
• Producing educational materials and activities
promoting the value of traceability in laboratory
medicine and raising awareness amongst
stakeholders;
• Encouraging the IVD industry to apply the
agreed reference measurement systems.
The main output of the JCTLM is the global
database of higher order reference materials;
reference measurement methods/procedures; and
reference measurement services. 9 This database is
freely available to any user. In July 2019, the
JCTLM database contained entries for some 300
reference materials and almost 200 reference
methods. The supporting output of the JCTLM
is a website that contains freely available
educational support materials, including
webinars, publications and presentations
from meetings. 10
Challenges in implementing traceability
in laboratory medicine at a global level
As the content of the JCTLM database
demonstrates, significant progress has been made
in the application of TLM to produce reference
materials and measurement procedures. However,
more than 1000 analytes are routinely measured
across laboratory medicine, and there are
significant challenges in implementing global
TLM for many of these analytes. These challenges
include:
• Geographical, cultural and language differences
• The variable use of SI units
• The growing biomarker repertoire, including
many complex analytes
• A lack of global coordination and leadership.
These challenges are being addressed but
progress is largely dependent on voluntary effort
and so it is too slow to meet the needs of patients.
A ‘call to arms’ has been issued to establish
a global forum to manage TLM. 11
A role for hospital and laboratory managers
in implementing traceability in laboratory
medicine
While much of the effort involved in achieving
TLM is a global endeavour, there are steps that
can be taken by hospital and laboratory managers
to protect patients and to educate the laboratory
users for whom they are responsible. These steps
include:
• Determine the traceability status of the methods
currently used and understand the measurement
uncertainty involved. This information will be
available in the small print of the instructions
for use provided by the IVD manufacturer
• Select new or replacement methods where the
traceability status is established
• Alert users to analytes where there is known
between method variability with a warning that
data from other laboratories may not be
transferable
• Ensure that all laboratory methods participate
in reputable external quality assessment (EQA)
schemes and evaluate performance on a regular
basis
• Refer staff and users to the TLM educational
support available from www.jctlm.org.
13
HHE 2019 | hospitalhealthcare.com
References
1 Beastall GH. Adding value
to laboratory medicine: a
professional responsibility. Clin
Chem Lab Med 2013;51:221–8.
2 IVD market overview. Allied
Market Research 2018. www.
alliedmarketresearch.com/
ivd-in-vitro-diagnostics-market
(accessed August 2019).
3 Greenberg N. Update on
current concepts and meanings
in laboratory medicine –
standardization, traceability and
harmonization. Clin Chim Acta
2014;432:49–54.
4 Plebani M. Harmonization
in laboratory medicine: the
complete picture. Clin Chem Lab
Med 2013;51:741–51.
5 Plebani M. Harmonization in
laboratory medicine: requests,
samples, measurement and
reports. Crit Rev Clin Lab Sci
2016; 53:184–96.
6 White GH. Metrological
traceability in clinical
biochemistry. Ann Clin Biochem
2011; 48: 393-409
7 Beastall GH, Brouwer N,
Quiroga S, Myers GL. Traceability
in laboratory medicine: a global
driver for accurate results for
patient care. Clin Chem Lab Med
2017;55:1100–08.
8 ISO 17511: 2003 In vitro
diagnostic medical devices
– measurement of quantities
in biological samples –
metrological traceability of
values assigned to calibrators
and control materials ISO,
Geneva, Switzerland; 2003.
9 JCTLM. JCTLM database
of reference materials and
measurement procedures.
www.bipm.org/jctlm/ (accessed
August 2019).
10 JCTLM. Working Group on
traceability, education and
promotion.www.bipm.org/
cc/JCTLM/Allowed/2015-11-
30/3_G-Beastall_JCTLM-WG-
TEP_2015.pdf (accessed August
2019).
11 Cobbaert C, Smit N, Gillery
P. 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. Clin Chem Lab
Med 2018;56:1598–602.