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This paper describes the development of the ISBT 128 coding and labeling for cellular therapy products. It is published on behalf of the international Cellular Therapy Coding and Labeling Advisory Group (see www.ICCBBA.org ).

The Comité Européen de Normalisation (European Committee for Standardization, CEN) Workshop on Coding of Information and Traceability of Human Tissues and Cells was established by the Expert Working Group of the Directorate General for Health and Consumer Affairs of the European Commission (DG SANCO) to identify requirements concerning the coding of information and the traceability of human tissues and cells, and propose guidelines and recommendations to permit the implementation of the European Coding system required by the European Tissues and Cells Directive 2004/23/EC (ED). The Workshop included over 70 voluntary participants from tissue, blood and eye banks, national ministries for healthcare, transplant organisations, universities and coding organisations; mainly from Europe with a small number of representatives from professionals in Canada, Australia, USA and Japan. The Workshop commenced in April 2007 and held its final meeting in February 2008. The draft Workshop Agreement went through a public comment phase from 15 December 2007 until 15 January 2008 and the endorsement period ran from 9 April 2008 until 2 May 2008. The endorsed CEN Workshop Agreement (CWA) set out the issues regarding a common coding system, qualitatively assessed what the industry felt was required of a coding system, reviewed coding systems that were put forward as potential European coding systems and established a basic specification for a proposed European coding system for human tissues and cells, based on ISBT 128, and which is compatible with existing systems of donation identification, traceability and nomenclatures, indicating how implementation of that system could be approached. The CWA, and the associated Workshop proposals with recommendations, were finally submitted to the European Commission and to the Committee of Member States that assists its management process under article 29 of the Directive 2004/23/EC on May 25 2008. In 2009 the European Commission initiated an impact assessment on the Workshop proposals and recommendations. In the absence of an agreed pan-European direction various initiatives have continued work using, adopting or adapting their preferred, or existing, methods.

Modern transplantation of cells, tissues and organs has been practiced within the last century achieving both life saving and enhancing results. Associated risks have been recognized including infectious disease transmission, malignancy, immune mediated disease and graft failure. This has resulted in establishment of government regulation, professional standard setting and establishment of vigilance and surveillance systems for early detection and prevention and to improve patient safety. The increased transportation of grafts across national boundaries has made traceability difficult and sometimes impossible. Experience during the first Gulf War with miss-identification of blood units coming from multiple countries without standardized coding and labeling has led international organizations to develop standardized nomenclature and coding for blood. Following this example, cell therapy and tissue transplant practitioners have also moved to standardization of coding systems. Establishment of an international coding system has progressed rapidly and implementation for blood has demonstrated multiple advantages. WHO has held two global consultations on human cells and tissues for transplantation, which recognized the global circulation of cells and tissues and growing commercialization and the need for means of coding to identify tissues and cells used in transplantation, are essential for full traceability. There is currently a wide diversity in the identification and coding of tissue and cell products. For tissues, with a few exceptions, product terminology has not been standardized even at the national level. Progress has been made in blood and cell therapies with a slow and steady trend towards implementation of the international code ISBT 128. Across all fields, there are now 3,700 licensed facilities in 66 countries. Efforts are necessary to encourage the introduction of a standardized international coding system for donation identification numbers, such as ISBT 128, for all donated biologic products.

Due to their limited availability and compatibility, biological products must be exchanged between medical institutions. In addition to a number of national systems and agreements which strive to implement a unique identification and classification of blood products, the ISBT 128 was developed in 1994, followed by the Eurocode in 1998. In contrast to other coding systems, these both make use of primary identifiers as stipulated by the document ISO/IEC 15418 of the International Organization for Standardization (ISO), and thus provide a unique international code. Due to their flexible data structures, which make use of secondary identifiers, both systems are able to integrate additional biological products and their producers. Tissue and cells also constitute a comparable risk to the recipient as that of blood products in terms of false labeling and the danger of infection. However, in contrast to blood products, the exchange of tissue and cells is much more intensively pursued at the international level. This fact is recognised by Directives 2004/23/EC and 2006/86/EC of the European Union (EU), which demand a standardized coding system for cells and tissue throughout the EU. The 2008 workshop agreement of the European Committee for Standardization (CEN) was unique identification by means of a Key Code consisting of country code corresponding to ISO 3166-1, as well as competent authority and tissue establishment. As agreed at the meeting of the Working Group on the European Coding System for Human Tissues and Cells of the Health and Consumers Directorate-General of the European Commission (DG SANCO) held on 19 May 2010 in Brussels, this Key Code could also be used with existing coding systems to provide unique identification and allow EU traceability of all materials from one donation event. Today Eurocode already uses country codes according to ISO 3166-1, and thus the proposed Key Code can be integrated into the current Eurocode data structure and does not need to be introduced separately. The Eurocode product classification for all products is based on its own unique coding system, which can be accessed over the internet by all users who are not themselves members of Eurocode. In summary, it can be said that the standardized single coding system for tissues and cells requires only unique sections in the data structure such the Key Code to fulfil the requirements of the EU Directive. Thus, various systems currently in place in different EU member states can continue to operate if the Key Code as suggested by the EU is integrated into them. The classification and description of each product characteristic is currently being discussed by the DG SANCO Working Group on the European Coding System for Human Tissues and Cells. Following intensive scrutiny in light of the stipulations laid out in EU Directives 2004/23/EC and 2006/86/EC as well as the CEN/ISSS workshop agreements, the Germany Federal Ministry for Health and organisations representing German tissue establishments under the responsibility of the German Society of Transfusion Medicine and Immunohematology, Working Party "Tissue preparations" proposed in 2009 that Eurocode be adopted for the donor identification and product coding of tissue and cells in Germany. The technical details for implementation have already been completed and are presented in the current article.

ISBT 128 is the global standard for the identification, labeling and information transfer of human blood, cell, tissue and organ products across international borders and disparate health care systems. The system has been designed and perfected over almost two decades to ensure accuracy, safety and efficiency for the benefit of donors, patients and health care workers worldwide. The use of the ISBT 128 standard has grown steadily since a blood bank in Estonia first implemented it in 1997. Today, more than 3,500 facility identifiers for the use of ISBT 128 have been assigned to organizations in 67 countries on six continents. The standard has been accepted by a variety of international standard setting organizations and government regulators. It is managed by ICCBBA, a not-for-profit organization based in the USA that is governed by an international volunteer board of directors. Members of the Board of Directors represent the fields of practice affected by the standard. Advisory groups comprising international experts guide the ongoing development of the ISBT 128 standard to ensure it continues to meet the needs of its users. While there is a cost associated with the implementation and use of the standard, the clear benefits in terms of improved patient safety and ability to meet regulatory traceability requirements justify the costs.