MANAGEMENT MATTERS
Metrological traceability of test results
An essential practice that must be adhered to.
By Daniel Tholen, BS, MS, and Randall Querry, BA
M
etrological traceability is a
10-syllable term that is difficult
to say, but important to under-
stand. It is essential to the validity of
clinical results, so it must always be con-
sidered. If clinical test results are to be
comparable across time, across different
instrument platforms, or across labs,
they must be metrologically traceable to
the same measurement reference.
Establishing metrological traceabil-
ity requires that the calibration mate-
rial used for a result (or a run, or series
of calibration materials), has certified
property values that have an unbroken
chain of comparisons going back to the
appropriate national or international
standard—for example, the use of cert-
fied reference materials (CRM) from
a National Metrology Institute (NMI)
such as the National Institute of Stan-
dards and Technology (NIST) which
have assigned values that are traceable
to the International System of units
(SI units). Other respected appropri-
ate standards that are used to establish
metrological traceability and are com-
mon to the clinical lab industry include
those produced by the World Health Or-
ganization (WHO) with arbitrary units,
often called “International Units” (IU).
Metrological traceability is the subject
of several ongoing efforts at the Joint
Committee for Traceability in Labora-
tory Medicine (JCTLM), the Interna-
tional Federation for Clinical Chemistry
and Laboratory Medicine (IFCC), and
the American Association for Clini-
cal Chemistry (AACC) Harmoniza-
tion Task Force and the International
Consortium for Harmonization. It has
been addressed by the International Or-
ganization for Standardization (ISO), by
the Clinical and Laboratory Standards
Institute (CLSI), and by The Interna-
tional Cooperation for Traceability in
Analytical Chemistry (CITAC).
The JCTLM is a project of the Interna-
tional Bureau of Pounds and Measures
(BIPM), and is composed of representa-
tives from BIPM, IFCC, and the Interna-
tional Laboratory Accreditation Coop-
eration (ILAC). ILAC is a cooperation of
95 laboratory accreditation bodies from
80 countries that accredit testing and
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calibration laboratories to the require-
ments of ISO/IEC 17025 and ISO 15189
The formal definition
As defined by the International Vo-
cabulary of Metrology (VIM), metro-
logical traceability is a “property of the
measurement result whereby the result
can be related to a reference through a
documented unbroken chain of calibra-
tions, each contributing to the measure-
ment uncertainty.” Notes in the defini-
tion clarify that a “reference” can be
a definition of a measurement unit, a
measurement procedure, or a measure-
ment standard, and (for internationally
recognized accreditation) the reference
should be a national or international
reference standard with traceability to
the International System of Units (SI),
where available.
It is important to recognize that metro-
logical traceability is different from other
forms of “traceability” within a labora-
tory. It is different from the traceabil-
ity of a sample as it moves through the
measurement system (sometimes called
“chain of custody”), and it is different
from the “traceability of calculations,”
which involve tracking original instru-
ment indications and any manual calcu-
lations or transfer of results. Metrological
traceability relates to the measurement
result itself, the data that is produced
in the laboratory that is provided to the
“customer,” and is used to make critical
decisions that could have direct impact
on the health of a patient. Metrological
traceability is about the units of mea-
surement, how the measurement results
compare to other measurement results,
and what the measurement results mean.
Metrological traceability helps ensure
that we are comparing apples to apples
and, furthermore, that we are comparing
a Gala apple to a Gala apple—and with
what level of certainty we can say that
our Gala apple is indeed a Gala apple.
Metrological traceability should not be
confused with tracking the sample or the
result as they move through the labora-
tory; rather, it relates a measurement
result back to a reference that allows (or
not) comparison to other results for the
same analyte.
Achieving metrological
traceability
Here are three common examples of
how metrological traceability can be
achieved:
1. Calibration to the SI (or other reference)
through a primary reference material from
an NMI (for example, in the United States,
to certified property values contained in
SRMs from NIST). This can be conduct-
ed by a single laboratory (for example,
glucose in serum).
2. Use of a reference measurement meth-
od by a network of expert laboratories
using a well-described reference mea-
surement method. This requires that all
laboratories are independently verified to
be competent (for example, creatinine in
serum).
3. Use of a reference method by a single
expert laboratory (for example, total
cholesterol in serum).
Establishing metrological traceability
can be expensive, but past efforts have
demonstrated benefits to anyone who
has tracked interlaboratory agreement
of measurements in recent years; that
is, whether improvements in method
agreement for creatinine, cholesterol, or
glucose seem like recent improvements
to you (or, in the experience of the prin-
cipal author, what has occurred with the
use of beta hCG measurements in the
past 35 years). Harmonization of results
obtained by different measurement
methods is possible for every analyte.
If you follow rules that require strict
adherence to the manufacturers’ guide-
lines, then there is little you can do to
affect the traceability of results that you
report. We recommend contacting the
manufacturers and requesting informa-
tion detailing how they ensure metro-
logical traceability of results using their
equipment. If you have inter-method
agreement factors to harmonize results
from different instruments in your labo-
ratory, there is also little else that you
can do to improve traceability.
Remember that metrological trace-
ability requires measurement results to
be traceable to SI units or another ap-
propriate reference when that isn’t pos-
sible. In a clinical laboratory, metrologi-
cal traceability is often achieved through
7/14/2017 11:20:58 AM
 MANAGEMENT MATTERS

®
the use of certified reference materials
or the use of reference methods. The
JCTLM maintains a searchable database
of certified reference materials, accepted
Puritan .
reference methods, and standardization
organizations, available at this address:
http://www.bipm.org/jctlm/.
We stand behind
List of resources
There is an abundance of literature on
this topic; easily available via internet
searches; the most current and
our products.
accessible (i.e., no cost) publications
are as follows:
• The AACC White Paper “The need to The Puritan® name is your guarantee.
harmonize clinical laboratory From product to product, box to box,
test results” (July 2015)
• The International Consortium on case to case, you can count on
Harmonization “Toolbox of consistent quality and performance
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harmonization” (June, 2013) That’s why customers keep coming
• The Eurachem/CITAC publication
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back for products such as our
measurement” patented HydraFlock® swab,
Relevant publications from Standards shown here. Call or visit our
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• CLSI EP32R “Metrological traceabil-
ity and its implementation”
(February, 2006)
• ISO 17511 “In vitro diagnostic
medical devices —Measurement of
quantities in biological samples —
Metrological traceability of values
assigned to calibrators and control
materials” (2003)

Daniel W. Tholen, BS,

MS, was the convenor
for the working groups
responsible for the
drafting of ISO/IEC
17043:2010 and ISO
13528, respectively.
Dan Tholen Statistical
Consulting, Traverse City, MI, provides
statistical consulting and serves as an
Visit us at AACC
American Association for Laboratory
Accreditation (A2LA) assessor. Booth #2349
Randall Querry, BA,
has been employed by
A2LA since 1998, and is
currently the Accredita- 207-876-331 1
tion Manager for Clini- puritanmedproducts.com
cal, Forensics and PT
sales@puritanmedproducts.com
Provider Accreditation
Programs. He conducts ISO 9001:2008 ISO 13485:2003
assessments, oversees assessors, and
serves as a lead peer evaluator on inter-
national accreditation body evaluations in
support of the regional mutual
recognition arrangements. US MANUFACTURED

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