ISBT 128 Implementation Plan for Cellular Therapy Products Paul Ashford,* Pat Distler, Adrian Gee, Alan Lankester, Stella Larsson, Irene Feller, Kathy Loper, Derwood Pamphilon, Leigh Poston, Fran Rabe, Ineke Slaper-Cortenbach, Zbigniew Szczepiorkowski, and Phyllis Warkentin International Cellular Therapy Coding and Labeling Advisory Group 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 levelsof computerization. It discusses projectmanagement, equipment, licensing, and validation topics. J. Clin. Apheresis 22:258–264, 2007. V V C 2007 International Cellular Therapy Coding and Labeling Advisory Group Key words: ISBT 128; terminology; labeling; coding; implementation INTRODUCTION This implementation plan guidance has been pre- pared by the international Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) to assist cellular therapy facilities with implementation of ISBT 128. The group has identified and addressed issues related to ISBT 128 implementation and logistics. Information provided is intended to be used as a guideline to be modified as necessary for each site. It should be noted that this document was written with an international audience in mind. It therefore does not endeavor to give details about specific stand- ards ornational/supranational regulatory requirements. The user is responsible for adheringto applicable requirements. This plan should be read and used in combination with the accompanying Standards for Terminology and Labeling ofCellularTherapy Products, and the ISBT 128 Standard Technical Specification [1]. These stand- ardswill be incorporated into future editions of the ISBT 128 Standard Bounded Lists and Definitions and the ISBT 128 Standard Product Code Structure and Labeling (Cellular Therapy) [2,3]. This document also assumes that the appropriate staff [Medical Director, Laboratory manager(s), Quality Officer,Information Technology manager(s), and other key personnel] have evaluated the benefits and costs of implementing ISBT 128 and the decision to implement it has been made. Therefore, this document is intended to assist this group with implementation. IDENTIFY PROJECT MANAGER Once the decision to implement ISBT 128 is made, in all likelihood, one person within the institution will orchestrate the facility’s conversion to ISBT 128. The earlierthisperson isidentified and willingly accepts the responsibility for the project, the better. This person is identified as the Project Manager. Identifying stake- holders and obtaining their acceptance and commitment for participation is key to successfully implement ISBT 128. ASSEMBLE AND REVIEW EDUCATIONAL MATERIALS The Project Manager should assemble pertinent edu- cation materials that are readily available regarding ISBT 128. Variousresourcematerialsare available (AABB 8101 Glenbrook Road, Bethesda, MD 20814- 2749.Tel 11 301-907-6977 Fax 11 301-907-6895. E-mail:aabb@aabb.org. http://www.aabb.org; ICCBBA, Inc. 1615 Orange Tree Lane, Suite 200 Redlands, CA 92374. Tel 11 909-266-3140, Fax 909-266-1828. E-mail: iccbba@iccbba.org. http://www.iccbba.org). These materials should be studied and utilized in planning, implementation, and training. EXECUTIVE MANAGEMENT BUY-IN Once the Project Manager understands ISBT 128 and the impact it will have on operations, the appropriate executive staff (those who may not have taken part in *Correspondence to: Paul Ashford,ICCBBA Inc, 1615 Orange Tree Lane,Ste 200, Redlands, CA 92374, USA. E-mail: paul.ashford@iccbba.org Published online 6 September 2007 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jca.20146 V V C 2007 International Cellular Therapy Coding and Labeling Advisory Group Journal of Clinical Apheresis 22:258–264 (2007)