IN 003 ISBT 128 For Blood
IN 003 ISBT 128 For Blood
IN 003 ISBT 128 For Blood
An Introduction
Editor
Matt Delgado,
Global Development Director
ICCBBA
Standards Committee
John Armitage, Prof., BSc, PhD United Kingdom
Paul Ashford, MSc. CEng. CSci. ICCBBA
Wayne Bolton, B.App.Sc., M.App.Sc Australia
Suzanne Butch, MA, MT(ASCP)SBB United States of America
Erwin Cabana, BA United States of America
Mónica Freire, BS United States of America
Jørgen Georgsen, MD Denmark
Mario Muon, MD Portugal
Stefan Poniatowski, BSc, MIBMS Australia
Leigh Sims Poston, BS, MT(ASCP) United States of America
Ineke Slaper-Cortenbach, PhD The Netherlands
Zbigniew Szczepiorkowski, MD, PhD, FCAP United States of America
Izabela Uhrynowska-Tyszkiewicz, MD, PhD Poland
Published by:
ICCBBA
PO Box 11309, San Bernardino, CA 92423-1309 USA
www.iccbba.org
Table of Contents
1 Preface ............................................................................................ 5
2 What is the Information Environment? ............................................ 6
3 The ISBT 128 Standard ................................................................... 9
4 Unique Donation Identification ...................................................... 10
5 Product Descriptions ..................................................................... 11
6 Other Data Structures ................................................................... 12
7 Delivery Mechanisms .................................................................... 13
8 Product Labeling............................................................................ 14
9 The Role of Technical Advisory Groups ........................................ 16
10 The Role of ICCBBA ..................................................................... 17
1 Preface
A great deal of important information is presented on the label of a blood
product. The information varies from country to country according to
licensing regulations, language differences and local practice but, in all
cases, it is essential that it is recorded accurately, transferred correctly,
and that critical items such as the blood groups, expiration date, and
product description are clearly understood by medical personnel
transfusing the product. In addition, robust audit trails must be in place to
allow tracing between donor and recipient.
Labeling
Delivery Mechanisms
Data Structures
Reference Tables
Standardized Terminology
Standardized Terminology
At the base lies the standardized terminology (ST-002 ISBT 128
Standard Terminology for Medical Products of Human Origin) that will
ensure the common understanding of terms. Without clarity at this level
any further attempt at standardization is lost. However, obtaining
agreement on standardized terminology at the necessary level of detail
involves careful analysis and robust consensus. A simple example
serves to illustrate this. The term ‘leukodepleted’ is widely understood as
meaning the removal of leukocytes from a blood component; however
there are different ways of carrying out such a removal, and differing
amounts of residual leukocytes that are used to define leukodepleted. In
order to accommodate these variations a range of standardized
terminology and associated values are required. Extreme care is needed
in order to ensure that an internationally agreed standardized
terminology is defined at the required level of granularity. This provides
confidence in the consistency of both the information being transferred
and the quality of the product described. The standardized terminology
needs to be accessible to all users of the standard.
© 2020 ICCBBA All Rights Reserved www.iccbba.org
ISBT 128 for Blood Components, An Introduction – 8th Edition 7
Reference Tables
Once the standardized terminology is in place, these can be combined to
give the required items of information. Reference tables are built to map
each item to a suitable code. Such tables can be large and complex and
it is essential that they are managed to ensure that they can be modified
to meet the changing needs of clinical practice in a manner that
maintains their integrity and avoids ambiguity or redundancy.
Data Structures
Having built reference tables which convert the clearly defined
information into codes suitable for electronic transmission, it is necessary
to define data structures in which to embed the data. Data structures
define the technical characteristics necessary for the interpretation of the
information. They specify the context and structure and provide the links
to the appropriate reference tables for conversion of codes to meaningful
information.
Data structures need to be clear and unambiguous and must take into
account any constraints imposed by the anticipated delivery
mechanisms. For example, data structures that will be used in linear bar
codes are limited in the number of characters they can contain.
Delivery Mechanisms
The delivery mechanism is the means of delivering the electronic
information. Probably the most well-known delivery mechanism is the
linear bar code that has been used in blood transfusion practice for many
years.
Labeling
The final element in the coding system is the associated labeling.
Although there will be other labeling requirements that fall outside the
coding system, an effective coding system needs to consider the
physical association between the information and the product. Whether
incorporated into a bar code or an electronic tag, there needs to be a
mechanism that will ensure correct physical assignment of information to
the product, and confidence in the association between electronically
stored information and eye-readable printed information. This latter
requirement must not be overlooked in the enthusiasm to embrace
remotely rewritable tags.
01
G1517 16 600001
where:
G1517 identifies the collection facility (in this case Welsh Blood Service,
Wales, United Kingdom);
The two digits printed vertically are flag characters that allow individual
bar codes in a number set to be discretely identified providing an option
to add process control.
5 Product Descriptions
ISBT 128 provides a comprehensive and highly flexible system for
describing products and assigning product codes. The foundation of this
system is a standard terminology which is constructed by international
consensus to ensure global consistency in use and understanding. The
standard terminology is maintained on the ICCBBA website and is
publically available. Blood component terminology is managed by the
blood transfusion Technical Advisory Groups of ICCBBA.
New entries into the Product Description Code Database can be readily
accommodated allowing the system to expand to meet a growing range
of products without losing the overall structure of the coding system.
7 Delivery Mechanisms
The delivery mechanism is the means by which the information is
represented in a machine-readable manner. The most common such
mechanism is the linear bar code. ISBT 128 has traditionally been based
on the linear bar code using Code 128 symbology and this is still
required on blood donations. However, an additional two-dimensional
Data Matrix code may be added to a blood component label.
A single Data Matrix code can carry the same information as encoded in
multiple linear codes. This allows much more rapid scanning of units at
the point of blood center issue and receipt into the transfusion laboratory.
In the cellular therapy and tissue banking fields, the need to use very
small containers means that label size is severely restricted and in these
situations a use of Data Matrix code may replace linear codes.
The Data Matrix symbol on the left contains all of the information held in
the five Code 128 symbols on the right.
There is also interest in the use of RFID tags. This technology is still
developing, but may provide benefits in some situations. ISBT 128
Compound Messages are compatible with RFID.
8 Product Labeling
In addition to specifying the requirements for the electronic coding of
information, ISBT 128 provides a standard labeling format that ensures a
consistent layout of the bar codes on product labels. Critical eye-
readable information such as blood groups, product description, and
expiration date also appear in fixed positions on the label. This reduces
the risk of confusion when products from multiple sources are being
used.
1 2
4 5
In addition to linear bar codes, a 2-D bar code, comprising all the
information in the linear bar codes, may be placed on the label. Scanning
a single code improves efficiency, but requires an imaging scanner.
For Blood Banking, the advisory groups are the Asia Pacific Technical
Advisory Group (APTAG), the Europe, Middle East, and Africa Technical
Advisory Group (EMATAG), and the Americas Technical Advisory Group
(ATAG). The groups comprise participants from blood collection facilities,
testing laboratories, transfusion services, professional organizations,
regulatory agencies, and vendors from around the world.
Blood, cellular therapy, tissue, organ, and banked human milk collection
facilities, and manufacturers of equipment or software that uses ISBT
128, are required to register with ICCBBA and pay a registration and an