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International Journal of Laboratory Hematology

The Official journal of the International Society for Laboratory Hematology

ORIGINAL ARTICLE INTERNAT IONAL JOURNAL OF LABORATO RY HEMATO LOGY

Recommendation for standardization of haematology reporting


units used in the extended blood count
M. BRERETON*, R. MCCAFFERTY † , K. MARSDEN ‡ , Y. KAWAI § , ¶ , J. ETZELL**, A. ERMENS † † FOR THE
INTERNATIONAL COUNCIL FOR STANDARDIZATION IN HAEMATOLOGY

*Central Manchester University S U M M A RY


Hospitals NHS Foundation
Trust, Manchester, UK Introduction: It is desirable in the interest of patient safety that the

St James’s Hospital, Dublin, reporting of laboratory results should be standardized where no
Ireland

Royal Hobart Hospital, Hobart, valid reason for diversity exists. This study considers the reporting
Tas., Australia units used for the extended blood cell count and makes a new
§
International University of ICSH recommendation to encourage standardization worldwide.
Health & Welfare, Sanno Methods: This work is based on a literature review that included the
Affiliate Hospital, Tokyo, Japan

Japanese Society for Laboratory original ICSH recommendations and on data gathered from an interna-
Haematology, Tokyo, Japan tional survey of current practice completed by 18 countries worldwide.
**Sutter Health Shared Results: The survey results show that significant diversity in the use
Laboratory, Livermore, CA, USA
†† of reporting units for the blood count exists worldwide. The use of
Amphia hospital, Breda, The
Netherlands either non-SI or other units not recommended by the ICSH in the
early 1980s has persisted despite the guidance from that time.
Correspondence: Conclusion: The diversity in use of reporting units occurs in three
Richard McCafferty, Haematol- areas: the persistence in use of non-SI units for RBC, WBC and pla-
ogy Dept., St James’s Hospital,
Dublin, Ireland. telet counts, the use of three different units for haemoglobin con-
Tel.: +353 1 4162067; centration and the manual reporting of WBC differential,
Fax: +353 1 4162920; reticulocytes and nucleated RBCs when the latter are available
E-mails: mccaffertyr@eircom.net;
from automated analysis or can be expressed as absolute numbers
Richard.McCafferty@stjames.ie
by calculation. A new recommendation with a rationale for each
parameter is made for standardization of the reporting units used
doi:10.1111/ijlh.12563 for the extended blood count.

Received 10 December 2015;


accepted for publication 11 July
2016

Keywords
ICSH, recommendation,
standardization, reporting units,
blood count

472 © 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS 473

over laboratory reporting and eliminate differences


A I M S O F T H I S PA P E R
where no valid clinical reason for the difference exists.
The aim of this study was to consider the opportuni- By providing professional guidance to users of our ser-
ties and challenges surrounding the standardization of vices, we can send a clear clinical message that is trans-
reporting units used for the complete blood cell count, ferable between pathology providers.
to review the progress made in this area since the The blood count (complete blood count CBC/full
1982 publications from the ICSH committee and to blood count FBC) is one of the most frequently
formulate a new recommendation to encourage stan- requested tests in laboratory haematology worldwide.
dardization worldwide. This work is based on a litera- It has evolved from the earliest days of laboratory
ture review and on an ICSH survey completed by 13 medicine when methods included cell counts achieved
nations. It also acknowledges work published from by manual microscopy and haemoglobin estimation
the Scandinavian Nordic Reference Interval Project by comparison of a solution of the patient’s blood to a
(NORIP), giving data from 18 countries worldwide in depth of colour index, through revolutionary auto-
total. mated cell counts using electrical impedance and spec-
trophotometry in the 1950s, to latest generation
analysers using multiple technologies including flow
INTRODUCTION
cytometry to produce a full ‘extended’ blood count
Individual patient pathology services may be sought that encompasses a full white cell differential, fluores-
from a variety of laboratories; this may be due to the cent or immunofluorescent platelet counts, automated
clinical needs of the patient, the requirement for speci- reticulocyte and nucleated red blood cell counts [6–8].
fic expertise, transport availability, geographical or The ICSH has given much consideration, since its
financial considerations or the movement of the indi- inception in the era of automated cell counters, to all
vidual. The electronic transfer of information and data aspects of the blood count, including methodologies,
is becoming increasingly common and may occur on an quality control, standardization, reference ranges and
international basis [1]. It is therefore essential that lab- of course reporting units [9–12]. Recommendations
oratories are clear about the services they offer and the and guidelines on these topics have been issued from
format in which the tests’ results are presented to users. the 1960s to the 1990s; nevertheless, variations in prac-
ISO states that units of measurement and appropriate tice exist around the world. The last 20 years have seen
reference ranges must be reported alongside any result much development in cell counter technology, infor-
but when users receive data with different units for the mation technology in the healthcare setting, point-of-
same test from different providers, the risk of confusion care testing and in delivery of pathology service. It is
is raised [2]. Some nations are already moving towards therefore appropriate that the reporting units used for
single electronic data resources for patients so that a the extended full blood count, which now include
patient’s health record is available to them when they complete white cell differential counts, reticulocyte and
travel. The need for consistency of reporting standards nucleated red blood cell counts, be revisited in the
is therefore essential. interests of standardization and patient safety [13].
The cost of pathology in health care is a major con- In 2013, to assess the extent of variation in report-
sideration, with mergers and multilaboratory partner- ing units for the extended blood count, the ICSH issued
ships formed across healthcare services; thus, providers an international survey among nine participating
of large-scale pathology require high levels of standard- countries. Subsequently, four other interested coun-
ization. Furthermore, the last 10 years have witnessed tries also submitted data in 2014 and information con-
a blossoming of point-of-care testing (near-patient test- cerning the reporting units used by the five countries
ing) technology, enabling patients to have routine of the Scandinavian Nordic Reference Interval Project
blood tests in less regulated locations (nonhealthcare (NORIP) group was made available to the authors, giv-
environments), some with limited clinical infrastruc- ing data from eighteen countries in total. The results of
ture or on-site expertise but seeking guidance from lab- the survey and the additional data are discussed below.
oratory professionals [3–5]. Considering patient safety, However, it is useful to first consider the original ICSH
it is the duty of the pathologist to remove confusion recommendations, which are set out below.

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
474 M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS

In the same publication [12], ICSH set out its rec-


Original ICSH recommendations
ommendation for the SI units to be used for haemato-
Cell counting technology has developed considerably logical results, which are reproduced showing the
since the early ICSH deliberations on the issue of components that are part of the blood count, in
reporting units and methods of measurement. In the Table 1 below. This shows the SI unit along with the
1982 publication ‘Advances in Haematological meth- alternative ‘conventional’ unit, indicating that ICSH
ods: The Blood Count’ [12], the ICSH summarized its recommended that the former be used.
position as previously agreed at its general assemblies In 1978, the ICSH recognized that the typewritten
and external meetings as follows: lower case l (litre) may be confused with the number
‘The International Committee for Standardization 1 and so the upper case L was also accepted.
in Haematology (ICSH), the International Federation It is important to note that, in addition to clearly
of Clinical Chemistry (IFCC) and the World Associa- stipulating the units to be used for each component of
tion of (Anatomic and Clinical) Pathology Societies the blood count, ICSH also recommended at this time
(WAPS) agreed to recommend to medical practitioners that haemoglobin concentration (and by extension
and all others concerned with health services the fol- MCHC) be expressed as g/L rather than as substance
lowing principles with regard to units of measurement concentration (mmol/L)(11th General Assembly,
for medical laboratory results: 1980). The use of g/dL was considered a ‘conventional
unit’ rather than a true SI unit [11, 12]. A review of
 The International System of Units (SI) is accepted the subsequent ICSH literature showed that, despite
in its broad application
the clear decisions made in 1980 and 1982, both g/L
 In accordance with chemical usage, the preferred and g/dL continued to be used to express mass con-
unit of volume is litre symbolized ‘ι’
centration, and less frequently, mmol/L was used to
 For multiples and submultiples of units, including express haemoglobin concentration.
derived units, only one prefix should be used. For
Dr Mitchell Lewis commented in 2009 in a review
preference, this should be confined to the numerator;
paper ‘International Council for Standardization in
exception is made in the case of the kilogram. Thus,
Haematology – the first 40 years’ [14] that the ICSH
units of concentration should use the litre as the
was represented at a meeting in Munich in 1972
denominator.
with the IFCC and the World Association of Pathol-
 For quantities concerning a component with suffi- ogy societies (WAPS) when it was agreed to recom-
ciently well-known chemical structure, ‘molecular
mend the use of SI ‘to the medical practitioners and
kinds of quantities’ based on amount of substance (us-
all others concerned with health services throughout
ing the unit mole) are recommended.*
the world’. He described that ‘whilst this would cre-
‘The position taken by ICSH was confirmed at the ate no difficulty in reporting blood cell counts, the
8th General Assembly (Jerusalem, 1974) and recon- ICSH was able to persuade the other parties that
firmed at the 9th General Assembly (Kyoto, 1976). At haemoglobin in molar concentration would be likely
that time, however, it was agreed that, when mass to confuse health workers in many countries for
concentration was used, gram per litre should be the whom haemoglobin measurement was the funda-
accepted unit for expressing results of haemoglobin in mental screening test’. The recommendation to adopt
blood. At the 11th General Assembly (Montreal, SI was supported shortly thereafter by the World
1980), there was again unanimous and strong Health Assembly [15]. Dr Mitchell also stated that ‘to
endorsement of the decision, taken at previous assem- avoid confusion, the ICSH recommended that for
blies, that in the context of haematology, haemoglo- both clinical interpretation of data and publication
bin should be expressed in g/L until convincing purposes, the differential leucocyte count should
argument can be presented on the advantages of always be expressed as the absolute numbers of each
expression as substance concentration’. cell type per unit volume of blood’.

*Because of uncertainty concerning the elementary entity of haemoglo- either in g/L (g/L) or in g/dL (g/dL). It is, however, permitted to use
bin to be used in calculation, ICSH recommends that for the time being, substance concentration (e.g. in mmol/L); in this case, the elementary
haemoglobin concentration in blood be expressed as mass concentration, entity (monomer or tetramer) should be specified’.

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS 475

Table 1. ICSH recommendation for reporting units used in the blood count, 1982

Conversion factor
Component Conventional SI conventional to SI unit

Erythrocytes 106/lL 1012/L 106


Haematocrit (PCV) % Fraction 0.01
Haemoglobin (in blood) g/dL g/L (Note a) 10
g/dL mmol/L (Fe) (Note b) 0.621
Leucocytes 103/lL 109/L 106
Leucocytes, differential count % Fraction 0.01
Mean corpuscular haemoglobin (MCH) llg pg 1
pg fmol(Fe) (Note b) 0.621
Mean corpuscular haemoglobin g/dL g/L (Note a) 10
concentration (MCHC) g/dL mmol/L (Fe) (Note b) 0.621
Mean corpuscular volume (MCV) l3 fL 1
Thrombocytes 103/lL 109/L 106
Reticulocytes
Relative % Fraction 0.001
Absolute 103/lL 109/L 106

Note a: ICSH recommendation 1976.


Note b:Although ICSH recommends g/L, mmol/L is acceptable as long as the elementary entity (monomer, tetramer) is
clearly specified, for example Fe or 4 Fe.
Adapted from Table 9, Advances in Hematological methods: The Blood Count (12) ‘some haematological laboratory
results expressed in “conventional” and in SI units’, showing only those components that are part of the extended
CBC/FBC.

worldwide. Guidance would appear to be needed for


R E S U LT S O F I C S H I N T E R N AT I O N A L S U RV E Y
all parameters including the following:
OF COMMITTEE MEMBERS 2013 AND
S U B S E Q U E N T DATA G AT H E R 2 0 1 4 • Reporting of cell counts.
• Reporting of white cell differentials, consideration of
The results of the ICSH international survey and
absolute values versus percentages.
subsequent data gathered are discussed below. Each
• Reporting of haemoglobin, where several different
co-ordinating national body was asked a series of
options are available.
questions, to which the replies are summarized. They
• Reporting of reticulocytes and nucleated red blood
were also asked to report on which reporting units, or
cells.
combination of units, are used in their country to
report all the parameters of the extended blood count. The survey results concerning individual parame-
These results are provided as Additional Supporting ters or components of the blood count are considered
Information (ASI) available for download with the below.
online version of this study.
White cell and platelet counts
Comments on survey results
The majority of countries report using the ICSH-
A review of submitted data shows several areas for recommended SI unit (109/L); however, there is per-
consideration. sistence of the use of the non-SI units (Giga/L, num-
Few countries appeared to have a unified system of ber per mm3, number per lL, number 9103/lL) in
reporting, or national recommendations, for units of various parts of the world, particularly in Korea and
measurement for the blood count. In addition, there Japan. In addition, there is variation in units used
is a very wide variation in the use of reporting units within France, the USA and particularly in Germany.

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
476 M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS

The white cell differential count is still reported as a


Other parameters (MCV, MPV, MCH)
percentage in many countries, although usually also
in absolute numbers in the same countries. MCV: There is excellent consensus here already, as all
respondents reported the use of the ICSH-recom-
mended unit (fL) and only France reported that some
Nucleated red blood cell counts laboratories use lm3.
The majority of countries report as absolute number MCH: There is also excellent consensus for this
(109/L) but also per 100 WBCs. parameter, as all respondents reported use of the
France and Japan report as per 100 WBCs, whilst ICSH-recommended SI unit pg, except Denmark and
Korea uses the non-SI unit 9103/lL. the Netherlands which use fmol, which is consistent
It was reported that in China, this parameter is with use as mmol/L to report haemoglobin concentra-
only available in some hospitals. tion in those countries.
MPV: This parameter is not routinely reported;
however when it is, the widely used unit is the fL.
Red cell counts France reported that there is no consensus.
There is reasonable consensus as the majority of coun-
tries report red cell counts using the ICSH-recom- Reticulocytes
mended units (1012/L). However, Japan and Korea
use non-SI units (106/lL) as do some laboratories in There is good agreement as the majority of countries
the USA. France and Germany also use Tera/L and report reticulocytes as the recommended absolute
#/mm3. number (109/L); however, many also report as a per-
centage, which introduces variation but of course can
be quite easily converted to absolute number. Only
Haemoglobin India and Korea stated that they only report as a per-
Haemoglobin concentration is reported variously as centage, whilst France reported that whilst 109/L is
g/L, g/dL, g/100 mL or mmol/L. It could be said used, Giga/L (G/L) and number per mm3 are also
that there is almost an even split among the major- used.
ity between the use of g/L and g/dL, whilst mmol/L
is the third most frequent unit used, followed by g/
Haematocrit
100 mL. Only the Netherlands and Denmark report
exclusively as mmol/L. However, the use of mmol/L Haematocrit (Hct) (PCV) appears to be reported vari-
still persists in Spain and France along with the use ously as either percentage or by volume (e.g. L/L) or
of other units, as it does in Germany where it was without units. The ICSH recommended use of the ‘frac-
used in the former East Germany; however, since tion’ or by volume as being compatible with SI and that
unification, the advice is to follow ICSH guidance the use of percentage should be discontinued.
for SI and g/L. National guidance is in place only in
the Netherlands and the UK, although the Scandi-
DISCUSSION
navian countries including Iceland, Finland, Norway
and Sweden have an agreement on reporting units There are many legitimate reasons why laboratories
through the NORIP group [16, 17] where haemoglo- have developed different ways of reporting the basic
bin is reported in g/L except in Denmark where it blood count profile. However, the growth of elec-
is reported as mmol/L. tronic reporting systems and the increase in global
healthcare providers are driving the need for harmo-
nization and standardization where clinically appro-
Red cell/Platelet distribution width priate. If results are reported in different formats,
These parameters are not routinely reported to the there is both a clinical risk that they will be misin-
clinician in some countries. They are reported vari- terpreted and a danger that abnormal results may
ously as fL or as a percentage. be simply missed.

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS 477

Quite clear guidance as to which units to use for manual microscopy is performed whilst carrying out a
the blood count is available from the early delibera- white cell differential, hence generating a result
tions of the ICSH outlined above, in which SI units expressing NRBCs per 100 white cells. However, such
were recommended. Nevertheless, our survey of a a result alone means little to the clinician, as it is not
total of eighteen countries has clearly shown that sig- an absolute number but depends entirely on the total
nificant diversity in practice exists worldwide. The white cell count. The UK Pathology Harmony group
authors regret that further countries were not recommended that NRBCs be reported as an absolute
included in the limited survey completed; in that, the SI number 9109/L [18]. However, when the result is
Middle East, Africa and South America are not repre- derived manually, this depends on the ability of the
sented. However, we feel that the survey we did carry local IT system to convert the manual result to an
out revealed that significant diversity without good absolute number using the total white cell count. As
reason exists and that therefore this point has been the counting of these cells moves from predominately
made. manual microscopy to automated methods, it is
If one takes an overall view of this diversity as preferable that their numbers should be reported as
regards the reporting of white cells, red cells and pla- an absolute value. However, the authors recognize
telets, it appears that the use of non-SI (or not recom- that consideration should be given to developing
mended) units of the type that the ICSH called countries where the automated method may not be
‘conventional units’ in the early 1980s (Giga/L, num- widely available, or IT systems may not have the
ber per mm3, number per lL, number 9103/lL, 106/ capability to automatically calculate the absolute
lL) has persisted despite the ICSH guidance from that number from the manual count.
time. An argument can be made on this basis alone, The unit of measurement used to report haemoglo-
for the use of these reporting units to be discontinued bin concentration, and by extension MCH and MCHC,
in favour of the SI units (109/L and 1012/L) already is split in the case of the majority between g/L and g/
used by many. Such a change alone would greatly dL but mmol/L is also used. Nevertheless, the ICSH in
improve standardization worldwide. the early 1980s recommended that g/L should be
The reporting of white cell differentials in percent- used. The use of mmol/L, whilst considered valid
ages should be discouraged as this only has meaning under the SI system, was discouraged by ICSH ‘to
when compared to the total white cell count. A clear avoid confusion of healthcare workers’ as described by
recommendation to this effect has already been made Lewis [14], ‘until convincing argument can be pre-
by the ICSH. Although the majority of reports sented on the advantages of expression as a substance
expressed in absolute units are derived from equip- concentration’. The ICSH survey reported in this study
ment with automated differential technology, the shows that the molar unit to report haemoglobin con-
reports from laboratories which still report percent- centration is only used exclusively in the Netherlands
ages no doubt derive from the production of differen- and Denmark and also by a minority of laboratories in
tial manual counts by microscopy. It is of course France, Germany (in the former East Germany) and
possible to convert the percentage result to absolute Spain.
numbers using the total white cell count, but this It is interesting that both g/dL and g/L are used
does depend on the IT system available. The authors almost equally worldwide, when the ICSH favoured
recommend that when the IT infrastructure is robust, g/L as being a ‘true’ SI unit, given that the use of g/
differentials should be reported in absolute values as dL breaks the rule emphasized in the joint ICSH-
a preference. IFCC-WAPS paper of 1972 recommending the use of
A similar issue applies to the reporting of nucleated SI units, that ‘only one prefix should be used, and
red blood cells (NRBCs) which are variously reported that for preference, this should be confined to the
as an absolute number, but also as a number per hun- numerator’, the litre being the denominator [11]. In
dred white cells. This parameter is an example of the conclusion, the early ICSH guidance was in favour of
impact of new cell counting technology, given that it the use of g/L and yet the other two forms have per-
has only been widely available on an automated basis sisted, whether for historical or local reasons, or
since the late 1990s. The NRBC count derived from because the ICSH judgment was not clearly

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
478 M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS

interpreted. The reporting units used to express MCH intractable problem given the diversity of reporting
and MCHC would follow logically from those used to units currently in use as revealed by the recent ICSH
express haemoglobin concentration. survey. Nevertheless, the arguments in favour of
Given that MCV is almost universally reported attempting greater harmonization are well made as
using the ICSH-recommended unit (fL), there should outlined in the introduction. Given the continuing
not be a significant issue as regards standardization for advances in the capabilities of cell counting technol-
this parameter. ogy, as well as in near-patient testing, along with
Haematocrit (Hct)(PCV) appears to be reported var- information technology for handling patient data
iously as either percentage or by volume (e.g. L/L) or advance, this is an appropriate time to reassess this
without units. The ICSH recommended use of the area. As discussed above, the early ICSH deliberations
‘fraction’ or by volume as being compatible with SI on the topic of reporting units resulted in clear recom-
and that percentage should be discontinued. mendations for the blood count; however, despite
Red cell distribution width (RDW), platelet distri- this, the use of nonrecommended units has persisted.
bution width (PDW) and mean platelet volume The current diversity in reporting units in use could
(MPV) are not always routinely reported. There was be considered in three main areas: (i) the persistence
an even split in reporting units for RDW between % in use of non-SI or non-ICSH-recommended units for
for RDW-CV and fL for RDW-SD. Most countries RBC, WBC and platelet counts in some countries, (ii)
reported PDW as fL and all reported MPV as fL, where the use of three different units for haemoglobin con-
these parameters are reported. The authors recom- centration and related parameters, with mmol/L used
mend using the SI unit fL as a preference, in the by a minority and a conversion factor of 10 difference
interest of introducing a standardized approach [16]. between the other two and finally (iii), the persis-
The problems that attach to the reporting of reticu- tence of manual reporting of blood film-derived
locytes are analogous to those that apply to the white results for white cell differential, reticulocytes and
cell differential and NRBC reporting, which are that nucleated red cells, when these are increasingly avail-
manual counting leads some laboratories to report as able from automated analysis and can be expressed as
a percentage of total red cells rather than as an abso- absolute numbers by calculation even when manually
lute number. The advent of automated reticulocyte derived. If a consensus could be achieved in even
counting in the latest generation cell counters has some of these areas, standardization of approach
improved reporting as an absolute number, and here, worldwide would greatly improve. Indeed, the diver-
the ICSH recommends use of 109/L. The calculation sity in reporting units that exists for some parameters
required to convert a percentage result to an absolute is simply a question of nomenclature, where the
number is straightforward. actual numeric value in a given blood sample would
Comments on ‘newer parameters’: Useful clinical be the same even when expressed in different report-
information can be gleaned from newer parameters, ing units. For example, a leucocyte count of
which are often innovations of individual equipment 5.0 9 109/L would have the same numeric value
manufacturers, such as percentage hypochromia of when expressed as giga/L or as 103/lL, although it
red cells, immature granulocytes or immature platelet would differ by a factor of 1000 when expressed as
fraction [16]. Reporting units for emerging tests are number per lL or number per mm3.
by their nature determined by the manufacturer as
they are developed; however, if they gain more wide-
International Considerations
spread use, they warrant attention as regards stan-
dardization. The desirability of standardization has been recognized
internationally, as shown by the fact that five coun-
tries in the Scandinavian region came together as the
C O N C L U S I O N S A N D R E C O M M E N DAT I O N
NORIP group [17, 19] to harmonize not only report-
The objective to introduce standardization in reporting ing units but also reference ranges for the blood
units used worldwide for the extended blood count, count; the United Kingdom implemented a Pathology
in the interest of patient safety, may seem like an Harmony initiative to standardize within the UK [18];

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS 479

and that the need to have one approach between the


Opportunities for standardization and rationale for
former East and West Germany has been recognized.
current recommendations
The Netherlands and more recently the United King-
dom have nationally agreed guidelines for units of The ICSH is in a good position to lead an international
measurement with the UK reporting haemoglobin in initiative aimed at improving standardization of report-
g/L and the Netherlands using mmol/L. Most coun- ing units for the blood count, or at least to provide a
tries have professional bodies that provide guidance, consensus recommendation. There are currently calls
with some reaching consensus in practice (e.g. Aus- in many countries to harmonize reporting in pathology
tralia); however, very little guidance is enforced and to the level of establishing common reference ranges
little is published as national recommendations. The (NORIP and UK Pathology Harmony); clearly, stan-
Royal College of Pathologists of Australasia has very dardization of reporting units is a minimal prerequisite
recently endorsed a set of guidelines [20, 21]. In towards achieving this. The international survey
China, the pathology services are growing at an expo- reported in this study has shown that very significant
nential rate with small and larger laboratories acquir- diversity in the use of reporting units for the blood
ing new equipment and new laboratories being set up count exists worldwide, whilst a review of the original
across China under the National Centre for Clinical literature on this topic shows that the ICSH and other
Laboratories (NCCL). professional bodies made quite clear recommendations
Where harmonization exercises have been carried for standardization based on expert consideration and
out, significant planning, communication with and acceptance that SI units should be used over 30 years
education of service users and detailed co-ordination ago. This paper makes a recommendation for standard-
are required. These are significant projects requiring ization based primarily on consensus on the units in
resources; however, they have been achieved success- majority use derived from the international survey,
fully as discussed above and perhaps ICSH has a role provided such are true SI units [22] and on expert opin-
in giving overall strategic guidance. However, deci- ion including that of the original ICSH recommenda-
sions to implement change ultimately rest with tions described above, where there is no clear majority
national bodies and healthcare authorities. It may be use of a single unit worldwide, such as in the case of
encouraging to note that few clinical incidents have haemoglobin concentration. The authors also consid-
been reported where standardization exercises have ered practical considerations such as the clinical utility
been carried out (for example, in the UK) [18]. of reporting units and the practicality of calculating
them where applicable, as treated in the discussion. A
rationale for the recommendation of units to be used
Consideration of cell counting technology available in
for each parameter is given in Table 2.
developing countries
Table 2 below summarizes the current proposed
The degree of automation and capabilities available for recommended reporting units for each parameter of
cell counting in developing countries should be consid- the extended blood count. The table lists the diverse
ered in any guidance or recommendation issued in reporting units used currently for each parameter,
regard to reporting units so that such guidance will be makes a recommendation for use of a single parame-
useful and can be applied. For example, automated ter where possible and includes a summary of the
flow cytometry-based methods for counting reticulo- rationale for each recommendation.
cytes and nucleated red cells are now well established It is unavoidable that implementation of standard-
in the developed world and lend themselves well to ization internationally would require agreement on
reporting in absolute numbers. These methodologies adoption of common units and implementation of
may not be so widely available in developing countries change in some countries. There is a need for input
and so guidance on reporting units should take account from clinicians, the cell counting and point-of-care
of that. It would be very useful for the ICSH to further industry, and national professional and EQA bodies in
develop its knowledge in this area and contact with lab- haematology in such change projects. Changes require
oratory professionals, and EQA providers in these agreement among national bodies, significant advance
regions could be developed further to facilitate that. planning and communication, and of course the

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
480 M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS

Table 2. ICSH recommendation for standardization of reporting units used in the blood count, 2016

Reporting Units currently Recommended Reason(s) for


Blood count parameter used worldwide reporting unit recommendation

WBC and platelet counts 9109/L 9109/L SI unit; previously


Giga/L recommended by ICSH;
9103/lL current majority use
Number per lL worldwide
Number per mm3
WBC differential count 9109/L 9109/L SI unit; previously
Percentage (%) (rather than % where recommended by ICSH;
9103/lL technology and/or more clinically
Number per lL IT capability allows) meaningful than %
Number per mm3
Nucleated RBC count 9109/L 9109/L (rather than SI unit; more
per 100 WBC per 100 clinically meaningful
9103/lL WBC where technology than per 100 WBC
and/or
IT capability allow)
RBC count 91012/L 91012/L SI unit; previously
9106/lL recommended by ICSH;
Tera/L current majority use
Number per mm3 worldwide
Haemoglobin g/L g/L True SI unit unlike
g/dL g/dL or g/100 mL;
mmol/L ICSH previously
g/100 mL did not recommend
mmol/L (used in
a minority of countries).
PCV/haematocrit L/L L/L SI unit; previously
Percentage (%) recommended by ICSH
MCV (mean cell volume) fL fL SI unit; previously
lm3 recommended by
ICSH; current majority
use worldwide
MCH (mean cell haemoglobin) pg pg SI unit; previously
fmol recommended by
ICSH; current majority
use worldwide
MCHC (mean cell As per haemoglobin As per haemoglobin As per haemoglobin
haemoglobin concentration)
RDW (red Cell distribution width) % fL as a preference SI unit; already
PDW (platelet distribution width) fL (where routinely reported as fL in
and MPV (mean platelet volume) % CV reported) many countries
Reticulocytes 9109/L 9109/L (rather than % SI unit; previously
Percentage (%) where technology and/or recommended by
Giga/L IT capability allows) ICSH; current majority
Number per mm3 use worldwide
9106/lL

logistics of adapting all laboratory and point-of-care implemented in various regions and within nations,
analysers, also laboratory, hospital and healthcare net- NORIP and the UK Pathology Harmony project being
work or regional IT systems that receive the results. examples. It may well be the case that initiatives out-
Nevertheless, such projects have been successfully side of the laboratory’s control drive the overall need

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482
M. BRERETON ET AL. | STANDARDIZATION OF REPORTING UNITS 481

for standardization regardless of whether or not an The ICSH thanks all those who contributed on
international initiative is undertaken. For example, behalf of their nations to the international survey in
the survey reported in this study has shown that stan- 2013, both to the ICSH survey and in providing supple-
dardization is already needed across borders in Europe mentary data as follows: ICSH members: Dr Katherine
(the survey comments indicated this), and also the Marsden – Australia RCPAQAP; Dr JM Jou – Spain; Dr
Republic of Ireland has committed to implement a Jin-Yeong Han – Korea; Prof. Ming Ting Peng – China
single national IT system for all pathology services, NCCL; Prof. Yohko Kawai – Japan; Prof. Keith Hyde –
which will require single reporting units for all results United Kingdom NEQAS(H), Dr C Thomas Nebe – Ger-
in all disciplines. These examples illustrate quite well many; Richard McCafferty – Republic of Ireland; Dr
that the dissemination of over-arching international Jean-Francois Lesesve – France; Dr Antony AM
guidance by the ICSH, as proposed in this study, is Ermens – the Netherlands; Dr Joan Etzell – USA CAP;
now very opportune. Dr Gini Bourner-Canada. Dr Shanaz Khodaiji – Mum-
bai, India. Prof. Per Simonsson and Prof. Gunnar Nor-
din – Equalis and the NORDIC REFERENCE INTERVAL
AC K N OW L E D G E M E N T S
PROJECT (NORIP) group of five Scandinavian coun-
This study was financially supported by the ICSH. The tries Denmark, Finland, Iceland, Norway and Sweden.
ICSH is a not-for-profit organization sponsored by
unrestricted educational grants from its corporate and
DISCLOSURE OF CONFLICT OF INTERESTS
affiliate members who are listed in the attached sup-
plementary file Appendix S2. The authors declare no conflict of interests.

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Supporting Information
Appendix S2. ICSH corporate and affiliate members.
Additional Supporting Information may be found in
the online version of this article:

Appendix S1. Results of ICSH International Survey


of Committee Members 2013 and subsequent data
gather 2014.

© 2016 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2016, 38, 472–482

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