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The Cellular Therapy Coding and Labeling Advisory Group of the International Council for Commonality in Blood Banking Automation and the International Society for Cell & Gene Therapy mesenchymal stromal cell (MSC) committee are providing specific recommendations on abbreviating tissue sources of culture-adapted MSCs. These recommendations include using abbreviations based on the ISBT 128 terminology model that specifies standard class names to distinguish cell types and tissue sources for culture-adapted MSCs. Thus, MSCs from bone marrow are MSC(M), MSCs from cord blood are MSC(CB), MSCs from adipose tissue are MSC(AT) and MSCs from Wharton's jelly are MSC(WJ). Additional recommendations include using these abbreviations through the full spectrum of pre-clinical, translational and clinical research for the development of culture-adapted MSC products. This does not apply to basic research focused on investigating the developmental origins, identity or functionalities of endogenous progenitor cells in different tissues. These recommendations will serve to harmonize nomenclature in describing research and development surrounding culture-adapted MSCs, many of which are destined for clinical and/or commercial translation. These recommendations will also serve to align research and development efforts on culture-adapted MSCs with other cell therapy products.

The article presents the essence of draft of the Guidance of good manufacturing practices of biomedical cell products (BMCP) (GMP/GTP guideline) harmonized with the international requirements, which contains the basic quality and safety standards of clinical application of these products. These regulations prescribe the requirements for institutions engaged in one or more stages of BMCP production and allow to avoid any risk of contamination of cells, tissues and finished product. The aim of this work is to develop a methodology for BMCPs' quality assurance framework. Materials and methods. The main subjects of research are national and international laws and regulations, publications on quality assurance systems of cell products, problems of BMCP manufacturing and validation. Results. The draft Guidance of good manufacturing practices of BMCP (GMP/GTP guideline), including specific requirements to donor determination, biomaterial sampling and its transportation to the manufacture, to risk management system, traceability system, to processing, definition of minimally manipulated BMCP, requirements to incoming control, continuous in-process control and control of finished BMCP, to pharmacovigilance system were developed. Specific features of the manufacture of test products for non-clinical and clinical studies are described. Assessment elements for certification prior to release of each batch of test BMCP were clarified. Recommendations on the introduction of a product coding system according to ISBT 128 Standard are given in this work.

Background: ISBT 128 is an international standard for the terminology, coding, labeling, and identification of medical products of human origin (MPHO). Full implementation of ISBT 128 improves traceability, transparency, vigilance and surveillance, and interoperability. Methods: ICCBBA maintains the ISBT 128 standard through the activities of a network of expert volunteers, including representatives from professional scientific societies, governments and users, to standardize and maintain MPHO identification. These individuals are organized into Technical Advisory Groups and work within a structured framework as part of a quality-controlled standards development process. Results: The extensive involvement of international scientific and professional societies in the development of the standard has ensured that ISBT 128 has gained widespread recognition. The user community has developed confidence in the ability of the standard to adapt to new developments in their fields of interest. The standard is fully compatible with Single European Code requirements for tissues and cells and is utilized by many European tissue establishments. ISBT 128's flexibility and robustness has allowed for expansions into subject areas such as cellular therapy, regenerative medicine, and tissue banking. Conclusion: ISBT 128 is the internationally recognized standard for coding MPHO and has gained widespread use globally throughout the past two decades.

Medical products of human origin (MPHO) distributed for use in assisted reproduction are currently labelled and identified using national or local systems. Products may be distributed internationally with potentially confusing identification labelling due to inconsistent terminology and definitions. In other fields of MPHO activity terminology has previously been standardized through professional collaboration as a precursor to adoption of a global standard for identification, coding and labelling. The International Council for Commonality in Blood Bank Automation (ICCBBA), an international nongovernmental organization in official relations with the World Health Organization, brought together representatives from professional societies to develop a terminology using a well-established methodology. The terminology was reviewed by professional associations and released for public comment. Further refinements were made following the comment period. Representatives of the American Society for Reproductive Medicine (ASRM), ESHRE, the Reproductive Tissue Council of the American Association of Tissue Banks (AATB) and ICCBBA met by international conference call and interacted by email. The terminology was developed using a standard model previously used across many areas of MPHO. A terminology comprising six classes, and six attribute groups has been developed. The terminology design is such that additional classes, attribute groups and attribute values can be added to meet the developing needs of the ART community. The level of detail incorporated into the terminology is based on the consensus view of the experts. The objective has been to provide sufficient detail to satisfy clinical need in product identification but there is the possibility that the level of detail may need to be adjusted in the future. The terminology is designed in a way that can readily accommodate such adjustments. Adoption of a standard terminology provides the basis for standardization of identification, coding and labelling and the use of internationally standardized barcoding to improve the accuracy and efficiency of information transfer and to reduce the risks of harm due to manual transcriptions errors.

Background: In blood transfusion services (BTS), selection of appropriate donor populations via clinical and serological screening is necessary to prevent transfusion-transmitted infections (TTIs). One of the strategies adopted by some Brazilian BTS is known as Subjective Donor Deferral (SDD), i.e., the rejection of a donation by the clinical triage interviewer based on subjective factors. Therefore, we aimed to evaluate if SDD has potential for increasing blood transfusion safety. Methods: We did a cross-sectional study involving blood donors who passed clinical triage from January 1, 2013, to December 31, 2015, in the Hematology and Hemotherapy Center of Ceara (Fortaleza, Brazil). Donor information was collected via the Blood Bank System (SBS) Web ISBT 128 database. They were evaluated for age, gender, education level, donation type and history, presence of confidential unit exclusion and/or SDD, and results of the standard serological screening (HIV, syphilis, human T-lymphotropic virus, and hepatitis B and C). Findings: 105,005 donors were included for analysis. Individuals subjectively deferred were 2.80 times more likely to have at least one reagent serology in the standard laboratory screening. Also, they were, respectively, 4.47, 5.69, and 6.14 times more likely to have positive syphilis, hepatitis B, and HIV screening. Interpretation: If positive infectious diseases markers rates correlate with the incidence of window period infections, implementation of SDD in clinical triage of blood donors may be an effective additional way to avoid TTIs, highlighting the importance of interviewer experience, perspicacity and face-to-face contact with the donor for blood safety assurance. Funding Statement: None received. Declaration of Interests: The authors declare they have no financial, personal, or professional conflicts of interests to disclose. Ethics Approval Statement: The study protocol was approved on 09 April 2018 by the Ethics Committee of the Center of Hematology and Hemotherapy of Ceara (Centro de Hematologia e Hemoterapia do Ceara; HEMOCE), number 8152.

Informatics plays an important role in every aspect of the clinical pathology laboratory, blood bank, and transfusion medicine service. Part of this chapter focuses on regulatory standards including Current Procedural Terminology (CPT), International Classification of Diseases (ICD), Health Level Seven (HL7), and Logical Observation Identifier Names and Codes (LOINC). The remainder of the chapter focuses on relevant topics in informatics including: bar coding and tracking; laboratory information systems; laboratory automation; middleware; workflow optimization; and database schemas.

Once a cohort exceeds a certain size, it becomes mandatory to assign an identifier (ID) for each individual to ensure a secure, reliable, and unambiguous assignment. In the field of hematopoietic stem cell transplantation, with a still growing number of voluntary unrelated donors, it was recognized that a system needs to be developed to uniquely identify potential donors on a global scale to facilitate communication and to prevent errors in identification of donors. Efforts in this respect resulted in establishment of the GRID, with a defined structure and allocated rules. To successfully implement such a project, collaboration among all organizations involved in the process of volunteer donor recruitment, facilitation, and provision of hematopoietic stem cell products is necessary. Therefore, rapidly accessible information combined with a high level of communication and exchange of experiences is crucial. Established systems like the ISBT 128 and the Single European Code (SEC), which standardize the terminology, identification, coding, and labeling of tissues and cells of human origin, serve as a basis on how to successfully implement the GRID on a global scale.

Background & Aim In the manufacture of cell-based medicinal products and ATMPs, the ISBT 128 Code has proven useful to provide a globally unique identifier and detailed characterization of a product. ISBT 128 coding is used for all products in our facility, a multi-purpose facility for cell-based products including ATMPs. With Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC coming into force, tissue establishments in the EU were obliged to affix a Single European Code (SEC) on tissues and cells distributed for clinical application. The SEC consists of two parts: a donation identification sequence, essentially indicating the origin of the tissue or cells, and a product identification sequence, classifying the type of tissue or cells. While the EU Tissue Code (EUTC) does not allow for a detailed characterization of the cellular product or tissue, the SEC offers the option to accommodate the ISBT 128 Product Description Code. We were contracted to perform the processing and cryopreservation of hematopoietic stem cells (HSC) for clinical use. The Contractor was required to retain his tissue establishment (TE) code on the final product. Labelling was to follow national rules and language. We describe how we integrated the ISBT 128 Product Description Code into the existing process and the SEC as follows. Methods, Results & Conclusion Both components of the SEC, the Donation Identification Sequence and the Product Identification Sequence, are generated at the Apheresis Facility (the Contractor), using the generic EUTC. - Upon receipt, the apheresis product is assigned an ISBT 128 Donation Identification Number for internal documentation, flag labelling, and release documentation, and an ISBT 128 intermediate Product Description Code for further processing. - The finished product is assigned a final ISBT 128 Product Description Code for administration. This code can be embedded in the SEC product identification sequence of the contractor. By doing so, the detailed characteristics are included in the ISBT 128 Product Description Code while retaining the contractor's TE Code and the unique collection identifier. As a next step, translated versions of the SEC/ISBT 128 label will be integrated into the Stemsoft Software labelling functionality (Stemsoft Software, Vancouver BC, Canada). We would like to invite other facilities to make use of this approach and of our documents developed for this purpose. Reference: ST-012 ISBT 128 and the Single European Code (SEC) v1.3.1 ( www.iccbba.org )

Background & Aim Background The Pathwest Bone Marrow Transplant Laboratory (BMTL) is the newest addition to the recently constructed Fiona Stanley Hospital Perth, WA. The laboratory was constructed to fulfil the need for a haemopoietic processing laboratory to service the adult stem cell programme, which is the only programme in the state to perform allogeneic stem cell transplants. The BMT Laboratory established a goal to attain FACT accreditation, ISBT 128 labelling was necessary to gain accreditation. Aim To complete the implementation, validation and quality plan for an efficient and cost effective ISBT 128 labelling system. This will allow the processing laboratory to receive, process, store and distribute haemopoietic stem cell products to meet the demands of the hospital, the regulatory bodies (FACT) and the larger international community as a distribution site (ABMDR). Methods, Results & Conclusion Methods The flow chart Pathwest followed in the implementation of ISBT 128 labelling contains 9 key steps, Change Control, Equipment (Equipment, Software, Supplies), ICCBBA Registration, Planning, Validation, Training, Go Live, Review and finally Audit of the system. Each step of the setup required completed documentation of testing and validation to sufficiently satisfy regulatory agencies and to ensure the labelling system complies with strict quality assurance programs. Results The BMT laboratory completed its implementation of ISBT 128 labelling at the end of September 2015 taking 6 months to plan and implement with the first ISBT 128 labelled haemopoietic HPC(A) graft processed and distributed in the same month. A total of 6 months was spent on the installation, validation of equipment and training of staff . BMTL was audited by FACT in June 2018. Conclusion The introduction of an ISBT 128 labelling system has required an implementation plan which covers the importance of setting out key steps and the review of its effect on procedures to ensure impact on the laboratory systems are kept to a minimum.

PURPOSE: To develop an internationally agreed terminology for describing ocular tissue grafts to improve the accuracy and reliability of information transfer, to enhance tissue traceability, and to facilitate the gathering of comparative global activity data, including denominator data for use in biovigilance analyses. METHODS: ICCBBA, the international standards organization for terminology, coding, and labeling of blood, cells, and tissues, approached the major Eye Bank Associations to form an expert advisory group. The group met by regular conference calls to develop a standard terminology, which was released for public consultation and amended accordingly. RESULTS: The terminology uses broad definitions (Classes) with modifying characteristics (Attributes) to define each ocular tissue product. The terminology may be used within the ISBT 128 system to label tissue products with standardized bar codes enabling the electronic capture of critical data in the collection, processing, and distribution of tissues. Guidance on coding and labeling has also been developed. CONCLUSIONS: The development of a standard terminology for ocular tissue marks an important step for improving traceability and reducing the risk of mistakes due to transcription errors. ISBT 128 computer codes have been assigned and may now be used to label ocular tissues. Eye banks are encouraged to adopt this standard terminology and move toward full implementation of ISBT 128 nomenclature, coding, and labeling.

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.

BACKGROUND: In 2001, the blood collection agencies of Zhejiang Province adopted a unified information system, but when a blood product was transferred from the collection and processing facility inventory to some other inventories, because of lacking the unique identifying ability between facilities, the numbers might be overlapped. The exchange of blood units between agencies needed change of labels, and it was very complicated. The SARS outbreak in 2003 made this problem more prominent. Therefore, we decided to redevelop a new information system based on ISBT 128 to solve this problem. STUDY DESIGN AND METHODS: We registered with ICCBBA and obtained the technical documentation and database. We requested the new product description code from ICCBBA and properly adjusted the incompatibility between ISBT 128 and the national standards. We redesigned the information system and labels and validated some related equipment and the laboratory information system. RESULTS: In May 2005, we completed the development of the new information system based on ISBT 128, and by the end of 2005, all the blood collection agencies of the Zhejiang Province began to use ISBT 128. As a result, the product information in blood collection agencies of Zhejiang Province can be shared, and the exchange of blood products between agencies became safe and rapid. It was highly praised by the nation's Ministry of Health. CONCLUSIONS: ISBT 128 was successfully implemented in Zhejiang Province.

The publication of new standards for terminology and labeling marks an important step in ensuring consistency and traceability of cellular therapies at the global level. However, it is only with the widespread implementation of the standard that the benefits can be truly realized. This paper provides guidance on the practical aspects of adopting these new standards for organizations with differing current levels of computerization. It discusses project management, equipment, licensing, and validation topics. J. Clin. Apheresis, 2007. © 2007 Internal Cellular Therapy Coding and Labeling Advisory Group.

ISBT 128 will be implemented in the United States during the next two years. In addition to improving unit traceability and lookback tracking, this information technology standard has the power to detect and prevent errors in data entry by using data identifiers and check characters. Additionally, its ability to encode special testing results such as CMV and RBC phenotype on a label provides laboratories a computerized mechanism to verify the accuracy of such labels. Immunohematology 2006; 22:30–36.

Background: Blood banks (BB) generate large volumes of information relating to patients and blood products sometimes stored indefinitely. Today computers are the main keys used to manage this task. BB information systems are developed mainly to assist BB specialists. Materials and Methods: We developed a new software, Hemosoft, in our blood bank. We have carried out a great deal of research into BB programs around the world in terms of program features. Using the latest technology, Hemosoft has been designed to run on a multi-user platform on the basis of a modular structure, and high security levels. Results: Hemosoft's structural advantages are: (1) its modular structure and client/server architecture reduce initial hardware costs. (2) Relational database structure provides consistent and secure data access, (3) user-friendly graphical interface, (4) according to operational needs, Hemosoft can be expanded and transferred on to different platforms. As a MS Windows ® based program with graphical user interfacing, Hemosoft has all the functions and advantages of windows based applications. Barcode printing is available to ISBT 128 standard. Hemosoft's integrated modules are: blood donation, transfusion, product management, administrative follow-up, apheresis, stock management, staff-management, inter-center communication, statistics, archive, internet and video-conferencing systems, accounts, integration and security. Conclusion: It fulfills international transfusion medicine requirements, legislative measures and guidelines. We believe that Hemosoft is a high quality, competitive program developed to meet international standards. It is our hope that it will enforce transfusion medicine and blood banking nationwide.

Medical products of human origin (MPHO) include blood, organs, bone marrow, cord blood, corneas, tissues, reproductive cells and milk derived from humans for therapeutic use. These materials, obtained from people whose safety, privacy and human rights need to be protected, provide important and often irreplaceable therapies. Obtaining MPHOs from living and deceased donors entails practical, scientific and ethical considerations. Transplantation of vascularized organs and viable tissues carries the same types of risk of disease transmission and incompatibility as blood transfusion, with additional risks and benefits. Donors must be carefully screened through medical history and laboratory tests, yet a thorough history is seldom available for deceased donors. Furthermore, the time from donation to transplantation is often short. Recipients, on the other hand, can die without a transplant. Thus, an MPHO, especially an organ, must be directed to a specific recipient, once the risk of disease transmission and the viability of the MPHO have been weighed against the poor prognosis without transplantation. This individual tailoring, which is critically important in the case of MPHOs, must be conducted reliably and verifiably. For MPHOs to be managed safely, organizational governance must guarantee transparency and traceability. Traceability – the ability to identify the unique origin of an MPHO by tracking the path from donor to recipient – is essential for vigilance, surveillance and activity reporting and to support recall of an MPHO. Because MPHOs can transmit disease,1 the risk of harm can be reduced by rapid notification or recall after disease transmission is identified in one recipient. The medical uses of MPHOs continue to expand. Many MPHOs are transported across national boundaries, but without uniform global standards for identifying their origins, their safety is compromised. Several countries have traceability requirements. However, these often vary for different types of MPHO because there is no global governance framework to ensure international consistency. These important problems have been recognized in global consultations on human cells and tissues for transplantation led by the World Health Organization (WHO). World Health Assembly Resolution WHA63.22 urges Member States “to encourage the implementation of globally consistent coding systems to facilitate national and international traceability”.2 A standard coding system based on globally standardized nomenclature would allow critical information on each MPHO and its origin to be presented in a format conducive to consistent interpretation globally and would overcome language barriers and facilitate electronic data capture and information transfer. An international initiative to ensure the global traceability of MPHOs is already well established. The Information Standard for Blood and Transplant (ISBT 128)3,4 was developed in response to problems in identifying the blood provided by different nations during the First Gulf War. The International Council for Commonality in Blood Bank Automation (ICCBBA) was established in 1995 as a not-for-profit organization to manage ISBT 128, which was introduced in 1996 for blood and extended to cell therapy and tissues in 2000. Today, ISBT 128 is used by more than 4500 facilities in over 60 countries and its use for organ transplantation is being piloted. It is endorsed and strongly supported by many international professional bodies and accreditation organizations and is being expanded to harmonize the nomenclature and coding of all MPHOs to ensure global traceability and biovigilance. To manage ISBT 128, the ICCBBA works closely with professional associations, transfusion and transplantation facilities and individual experts to develop strong expert consensus internationally. Health authorities in many countries accept ISBT 128 as an effective solution for blood and blood products and some mandate its use. A 2012 international transplantation workshop5 convened by WHO considered global traceability and recommended close collaboration between national health authorities and agencies and scientific and professional societies, with the ICCBBA and WHO managing a global governance service for the coding and labelling of MPHOs. ISBT 128 has been highly successful where it has been adopted but global standardization, not yet realized, will depend on international confidence in the long-term sustainability of ISBT 128 and protection of the standard from commercial exploitation, potentially through agreement between the ICCBBA and WHO. The development of an international coding system for MPHOs requires either creating a new system or ensuring a role for the ICCBBA as provider of the global service for nomenclature and coding. Attaining the WHA63.22 objective of globally consistent coding systems will involve the gradual adoption of ISBT 128 by organizations as an element of their development programmes. Implementation of such an international coding system will also require an understanding of the importance of consistent coding and of international traceability and transparency.

Over the past few decades, many efforts to improve the safety of blood products have concentrated on the reduction of transfusion-associated infectious diseases, particularly human immunodeficiency virus and hepatitis C. As health care enters a time of significant economic changes and governmental agencies develop guidances to improve patient safety, new efforts are being implemented and new technologies are being developed to ensure safe delivery of blood products. This article outlines the structure of agencies responsible for blood safety in the United States, reviews the fairly recent implementation of a blood product bar-code labeling system (ISBT 128) in the United States, describes safety efforts at the level of the hospital transfusion service, and reviews some of the emerging technologies for safety in blood delivery at the bedside.

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.

The International Cellular Therapy Coding and Labeling Advisory Group was established to address the growing need for standardization of terminology and labeling for cellular therapy products as a result of increasing international transfer of these products. This paper presents new standards for terminology and labeling. These standards have been developed through a consultative process and are supported by key professional and accreditation bodies. By using these standards, together with the unique donation identification numbers and international product reference tables provided by the International Society of Blood Transfusion (ISBT) 128 Standard, consistency and traceability can be assured at the global level. A companion paper provides guidance on the implementation of the ISBT 128 system.

T hese standards have been developed through the co-operative endeavor of the following organizations: 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). The use of standard terminology will help to ensure a common understanding of product definitions. The labeling standard, supported by the ISBT 128 information system, will ensure unique global identification of cellular therapy products, an international reference table for product descriptions, and label design that is consistent worldwide. The organizations supporting these standards believe that their adoption will significantly improve the quality, safety, and traceability of cellular therapy products. In developing the terminology standard the Advisory Group recognized that the frequent movement of cellular therapy products between countries (and continents) required a consistent use of terminology between ISBT 128 and other published standards (e.g., Circular of Information, AABB, FACT, JACIE, Netcord). The Advisory Group has attempted to achieve these aims by removing complexity and redundancy from the coding system wherever possible and, by wide consultation, agreeing to terminology acceptable to all for inclusion in future publication of their standards and guidance. TERMINOLOGY STANDARD

BACKGROUND: In today's world of multinational disaster relief programs, blood collected and processed in one country may be used in another. A great deal of important information is carried by a blood product label. Given the concerns about safety and traceability, it is important to use globally unique blood product coding and labeling system. STUDY DESIGN AND METHODS: In 1994 the International Society of Blood Transfusion (ISBT) gave a group, ICCBBA (formerly called International Council for Commonality in Blood Banking Automation), the responsibility for implementing a new, safe international system for coding and labeling blood products. This new system is based on 128 bar code symbology and is called ISBT 128. This study describes how ISBT 128 was implemented in blood banks in Norway. RESULTS: As soon as a couple of the most central blood banks implemented the system and started to use it in 2001, they found that it was much easier to handle than their old systems. There were two different software systems being used that were ISBT 128-compliant. The facilities started to export and import blood products to each other. The “foreign” blood products were easily scanned into “own” inventory. They were reluctant to order blood products from blood banks not using ISBT 128. Because of the success in the Department of Immunology and Transfusion Medicine at the University Hospital of Akershus and some other blood banks in Norway, the Norwegian Health Authorities advised all the blood banks to implement ISBT 128. CONCLUSION: The use of ISBT 128 has been a success from the very beginning.

Barcode technology has been widely employed in medicine and healthcare industry. In this paper, it firstly introduces the application of barcode technology in information automation system oriented to blood banks and other transfusion facilities. In the following, the label paradigm of Codabar in Macao Blood Transfusion Center (CTS-Macau) is examined through the comparison with ISBT 128, an international barcode and labeling standard for blood and blood products. And then, it tries to exemplify the supersedure of Codabar by ISBT 128 via the implementation of barcode labeling system at CTS-Macau. This paper is intended to serve as a reference of implementing barcode technology in blood bank automation system.

A survey of blood centre organizations was carried out to establish the degree of progress towards the implementation of global standards for coding and labelling blood components. The survey was performed through questionnaires completed by blood organizations. Of nearly 32 million blood donations collected annually by the participants, 43% are identified with ISBT 128 donation numbers and 36% are fully compliant with the ISBT 128 Standard. Planned implementations indicate that 85% of donations will be identified by ISBT 128 donation numbers by 2011.

The role of information technology in blood services and hospitals is becoming increasingly important to support the quality of processes and the speed and integrity of information transfer. This holds true from the collection of blood from donors and samples from patients to the processing, testing, distribution and transfusion of blood and blood components. Within this rapidly changing environment the role of SACIT is to provide advice to the UK Blood Transfusion Services. It achieves this by defining standards and recommending these to the UKBTS/NIBSC Joint Professional Advisory Committee (JPAC) for implementation by individual services. To underpin this it defines strategies for how information systems can support the UK services and hospitals, builds relationships with UK and international colleagues working in the field and promotes improvements in Quality through IT. In order to do this the group consists of individuals bringing both expertise in IT and knowledge of the whole ‘transfusion chain’, across the UK, from blood services and hospitals. During 2006/07 the group will work across a range of areas including; driving forward the development of commonality in labelling and bar coding across the UK services, promoting the use of electronic messaging, building relationships with the NHS IT programmes, promoting the further implementation of ISBT 128 and reviewing new technologies.

a revision of the terminology was drafted to eliminate the “TC” class designation and to create a more consistent format for cellular therapy class terms. The revised terminology also takes into consideration consistency with nomenclature used for tissue products. Changes will not affect HPC terminology which represents about 65% of ISBT 128 product description codes. For class names that will change, not all nomenclature changes will result in a change to the ISBT 128 product description code (“S” code). While accepting that changing terminologywill create rework for facilities that have implemented ISBT128 anddelay for those in the process of implementation, it is felt the revised terminology provides a strong foundation for consistent nomenclature as new products are developed and addresses regulatory concerns. An appropriate timescale for implementation of the revised terminology will be developed. This presentation will describe the revised terminology and explain the reasoning supporting the changes.

The Transfusion Medicine Service (TMS) covers diverse clinical and laboratory-based services that must be delivered with accuracy, efficiency and reliability. TMS oversight is shared by multiple regulatory agencies that cover product manufacturing and validation standards geared toward patient safety. These demands present significant informatics challenges. Over the past few decades, TMS information systems have improved to better handle blood product manufacturing, inventory, delivery, tracking and documentation. Audit trails and access to electronic databases have greatly facilitated product traceability and biovigilance efforts. Modern blood bank computing has enabled novel applications such as the electronic crossmatch, kiosk-based blood product delivery systems, and self-administered computerized blood donor interview and eligibility determination. With increasing use of barcoding technology, there has been a marked improvement in patient and specimen identification. Moreover, the emergence of national and international labeling standards such as ISBT 128 have facilitated the availability, movement and tracking of blood products across national and international boundaries. TMS has only recently begun to leverage the electronic medical record to address quality issues in transfusion practice and promote standardized documentation within institutions. With improved technology, future growth is expected in blood bank automation and product labeling with applications such as radio frequency identification devices. This article reviews several of these key informatics issues relevant to the contemporary practice of TMS.