Cells and Tissue Traceability and ISBT 128
by: Dr. Michael Strong, former Vice-President of Research and Development at Genetic Systems and
former Director of Laboratories and Chief Operating Officer at the Puget Sound
Blood Center
Introduction
There are 30 million blood products; 2.2
million tissue products and 18,000 stem cells collected each year in the United
States. Biological products may be collected in one country and distributed in
another. Cellular therapy and tissue products are particularly likely to cross
an international border because of both availability issues and the need for
products that are precisely matched. The recent highly publicized scandal with
illegally procured and distributed tissues showed that over 2,000 tissue grafts,
distributed around the world, could not be traced.
30 million blood products; 2.2 million tissue products and 18,000 stem cells are collected each
year in the United States.
Traceability
A critical requirement for such products is
the need for traceability, which becomes more challenging when products must be
traced through completely different environments (regulatory, health care
delivery systems, levels of automation, etc). Additionally, there is a need to
label the product in a way that can transcend language barriers.
The key to satisfying these requirements
lies in standardization: globally unique identifiers for products, standardized
terminology and a means to convey information electronically that is recognized
by computer systems throughout the world. Towards this end, ISBT 128 had been
developed.
ISBT 128 is an international standard for
the transfer of information about blood, cellular therapy, or tissue products.
This transfer can be through bar codes on labels (both linear and
two-dimensional), Radio Frequency Identification (RFID) tags, or electronic
messaging. In support of traceability, ISBT 128:
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Creates a system for assignment of identifiers for products that are globally
unique for a period of 100 years.
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Defines nomenclature for products through a global consensus process
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Establishes codes for the defined-products to allow efficient data transfer
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Creates codes for other critical information (blood group information,
expiration date, etc.)
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Incorporates the codes into a shared database that is made available to all
ICCBBA-licensed facilities through its website. Adding a local translation to
the shared database allows translation into local languages (see Figure 1).
Figure 1. Use of ISBT 128 Database Table for Tranlation
The standard is managed by ICCBBA, a
not-for-profit company (www.iccbba.org).
While ICCBBA is based in the US, it has a multi-national volunteer Board of
Directors.
Blood
ISBT 128 began as a blood standard. It
became clear during the Persian Gulf War (1990-1991) that when blood was
received from a variety of sources in different countries, there could be
duplication in "unique" identifiers as well as difficulty in reading labels with
different languages. Although bar codes, such as Codabar and Code 39, were
frequently present, the messages contained within them had different meanings.
Additionally, during the 1990's it became increasingly common to establish
centralized testing laboratories. When multiple blood centers submitted their
samples to a single laboratory for testing, it was found that identifiers were
often unique only within the context of the facility in which products were
drawn.
As a result of this growing need for
globally unique identifiers and standardization of bar coded information, the
International Society of Blood Transfusion (ISBT) charged its Working Party on
Automation and Data Processing [subsequently renamed the Working Party on
Information Technology (WPIT)] with creating a standardized means of labeling
blood products such that identifiers were globally unique and bar codes (as well
as other means of electronic information transfer) would have the same meaning
internationally.
European blood banks began adopting ISBT 128
in the late 1990's and others followed. The AABB (formerly the American
Association of Blood Banks) established it as a standard in 2008. The use of
ISBT 128 has since spread to tissues and cellular therapy products.
Tissues
The National Health Service Blood and
Transplant, Tissue Services in the United Kingdom was first to use ISBT 128 for
tissues. They fully implemented ISBT 128 for tissue in 2003. Since then,
facilities in other countries have implemented the standard. In the US, ICCBBA
has been working with the American Association of Tissue Banks (AATB) to
establish common terminology for tissue products, the first step in the
standardization process.
In 2004, a European Union directive mandated
a single coding system for cells and tissues [European Tissues and Cells
DIRECTIVE 2004/23/EC (ECD)]. To this end, the European Committee for
Standardization (or Comité Européen de Normalisation or CEN) evaluated various
standardized coding systems for use within the European Union. Their report was
published in 2008 (CEN Workshop Agreement on 'Coding of Information and
Traceability of Human Tissues and Cells'
CWA_Coding-for-T-and-C_v2000_20080522.doc
ftp://cenftp1.cenorm.be/PUBLIC/CWAs/e-Europe/Tissues_cells/CWA15849-2008-publishedtext.pdf).
The report recommended that ISBT 128 be used
as the single European coding system for coding cells, tissues and organs. They
determined that one of the major benefits of ISBT 128 was that it could be used
for four groups of biologics: blood, cells, tissues and organs. Among their
conclusions:
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The ability to share coded data between different donor sectors in the future
may help with risk prevention measures and provide clearer indications of donor
suitability.
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It may also reduce duplication and ensure better recall management.
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It is feasible that with technological advances in regenerative medicine that
the interfaces between blood, tissues, cells, and organs may become less
defined.
Cellular Therapy Products
Beginning in 2005, a group comprising
representatives from AABB, American Society for Blood and Marrow Transplantation
(ASBMT); American Society for Apheresis (ASFA); European Group for Blood and
Marrow Transplantation (EBMT); Foundation for the Accreditation of Cellular
Therapy (FACT); ICCBBA, International Society of Blood Transfusion (ISBT);
International Society for Cellular Therapy (ISCT); ISCT Europe; Joint
Accreditation Committee of ISCT and EBMT (JACIE); National Marrow Donor Program
(NMDP); and the World Marrow Donor Association (WMDA) began working to expand
ISBT 128 for use in the field of cellular therapy. While a number of facilities
had used ISBT 128 for cellular therapy products since the late 1990's, this
group greatly expanded the terms and definitions to meet evolving needs. Their
work was published in a variety of journals. Beginning in 2008, ISBT 128
terminology was required by FACT, JACIE, and AABB standards for labeling
cellular therapy products. The requirement by these organizations for full ISBT
128 labeling (bar codes and label design) is still a few years off to allow for
enhancement of computer systems. However, some cellular therapy facilities that
also handle blood are already in the process of implementing the full label.
Cooperative Efforts Between ICCBBA and GS1
GS1 is a leading global organization
dedicated to the development and implementation of standards and solutions to
improve efficiency and visibility of supply and demand chains internationally
and across sectors. The GS1 system of standards is the most widely used supply
chain standards system in the world.
Because pharmaceuticals are often labeled
with GS1, pharmacy systems typically are capable of reading GS1. However, plasma
derivatives are handled entirely by the blood bank in some countries (e.g.,
Australia and Canada) or partially handled by the blood bank (e.g., RhIg in the
US) in others. Therefore there is a need to develop bar coded labeling and
computer systems so that these products that can be read by either the pharmacy
or the blood bank. Similarly, it would be advantageous to have a single patient
wristband system that can be used to appropriately identify patients for
medications, blood, tissue or cellular therapy products.
Because of these needs, ICCBBA and GS1
signed a Memorandum of Understanding in 2007 in which they agreed to develop a
closer working relationship resulting in compatibility between their standards
and well defined interfaces. The two organizations are currently working on
projects to create interoperability between their standards for patient
identification and the labeling of plasma derivatives.
Status of ISBT 128
ICCBBA began assigning facility
identification numbers (FIN) to blood, tissue and cellular therapy organizations
in 1996. Today, more than 4000 facility identification codes have been issued to
facilities in 70 countries. While not all facilities with assigned codes have
implemented ISBT 128, obtaining a FIN is the first step in implementation. In
some countries, the use of ISBT 128 is required by government regulations or by
standard setting bodies.
Conclusion
As biological products are increasingly
shared across the globe, the challenges of traceability and biovigilance become
greater. Further, as the volume of products increases, the need for automation
to accurately track data increases. To support these needs, a single global
coding system is required, and ISBT 128 is such a coding system. As a result,
its use has been growing steadily over the past decade.
Dr. Michael Strong
began his career in 1965 as the Supervisor of the Blood Bank of the 1600-bed
Naval Hospital in Philadelphia, Pennsylvania. During 15 years of research at the
Naval Medical Research Institute in Bethesda, Maryland, he was involved in the
establishment of the Organ and Bone Marrow Transplantation units of the Army and
Navy; Histocompatibility, Clinical Immunology and Tissue Banking Programs at the
National Naval Medical Center; and the institution of the National Marrow Donor
Program.
Dr. Strong retired from the Navy in 1985 and
moved to Seattle to become Vice-President of Research and Development at Genetic
Systems, a biotech company. He joined the Puget Sound Blood Center in 1988 to
establish the Northwest Tissue Center. He served in different capacities at the
Blood Center, including Director of Laboratories and Chief Operating Officer and
retired from the center in 2007. He holds research professor appointments in the
Department of Orthopaedics and Sports Medicine, and the Department of Surgery at
the University of Washington School of Medicine.
During his more than 40-year career, Dr.
Strong has written for more than 400 publications, including more than 65 book
chapters in blood and tissue banking and has lectured at over 35 universities
and hospitals on six continents. He currently serves as the North American
Editor of the Journal of Cell and Tissue Banking. He has served on several
boards including the American Association of Tissue Banks and the Northwest
Organ Procurement Agency, and as President of the AABB (formerly the American
Association of Blood Banks). He currently chairs the AABB's U.S. Bioviglance
Network Steering Committee.
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