Fran Rabe

Standards for the Terminology and Labeling of Cellular Therapy Products

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

Training practices of hematopoietic progenitor cell–apheresis and –cord blood collection staff: analysis of a survey by the Alliance for Harmonisation of Cellular Therapy Accreditation

As hematopoietic stem cell transplantation expands globally, identification of the key elements that make up high‐quality training programs will become more important to optimizing collection practices and quality of the products collected.

Terminology and labeling of cellular products: 1. Standards.

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.

Erratum: Training practices of hematopoietic progenitor cell-apheresis and -cord blood collection staff: analysis of a survey by the Alliance for Harmonisation of Cellular Therapy Accreditation (Trans (2014) 50, (3138-3144) 10.1111/trf.13173)

Celluzzi CM, Keever-Taylor C, Alurf M, Koh MBC, Rabe F, Rebulla P, Sacchi N, Sanders J, McGrath E, Loper K, on behalf of the Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA). Training practices of hematopoietic progenitor cell–apheresis and –cord blood collection staff: analysis of a survey by the Alliance for Harmonisation of Cellular Therapy Accreditation. Trans 2014;54:3138-44. The authors regret the misspelling of Mahmoud Aljurf, the third author of this manuscript.

Training practices of hematopoietic progenitor cell-apheresis and -cord blood collection staff

As hematopoietic stem cell transplantation expands globally, identification of the key elements that make up high‐quality training programs will become more important to optimizing collection practices and quality of the products collected.

Training practices of hematopoietic progenitor cell-apheresis and -cord blood collection staff: analysis of a survey by the Alliance for Harmonisation of Cellular Therapy Accreditation: HPC Collection Staff Training Practices

As hematopoietic stem cell transplantation expands globally, identification of the key elements that make up high‐quality training programs will become more important to optimizing collection practices and quality of the products collected.

Establishment of an unrelated umbilical cord blood bank qualification program: ensuring quality while meeting Food and Drug Administration vendor qualification requirements

Qualification of a cord blood bank (CBB) is a complex process that includes evaluation of multiple aspects of donor screening and testing, processing, accreditation and approval by professional cell therapy groups, and results of received cord blood units. The University of Minnesota Medical Center Cell Therapy Laboratory has established a CBB vendor qualification process to ensure the CBB meets established regulatory and quality requirements.