For Blood & Biologics
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
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.
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:
Figure 1. Use of ISBT 128 Database Table for Tranlation
- Creates a system for assignment of identifiers for products that are globally unique for a period of 100 years.
- Defines nomenclature for products through a global consensus process
- Establishes codes for the defined-products to allow efficient data transfer
- Creates codes for other critical information (blood group information, expiration date, etc.)
- 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).
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.
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.
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'.
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:
- 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.
- It may also reduce duplication and ensure better recall management.
- It is feasible that with technological advances in regenerative medicine that the interfaces between blood, tissues, cells, and organs may become less defined.
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.
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.
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.
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.