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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 The draft Guidance of good manufacturing practices of BMCP (GMP/GTP guideline), including specific requirements to donor determination, biomaterial sampling and its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.

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.

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 ).

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.

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.

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.

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.

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.

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.

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.