ROUNDTABLE - ICCBBA: Implementation Strategies for a Standardized Chain of Identity Identifier
Saturday, June 3, 2023 11:45 AM - 12:45 PM
Room 242A
Regulation & Reimbursement
Roundtable
Perspectives on the benefits of, and barriers to, implementing the standardized ISBT 128 Chain of Identity Identifier
Moderator
Lizette Caballero, BS, MLS(ASCP)CM, Clinical Cell Therapy Liaison, Janssen Pharmaceutical Companies of Johnson & Johnson, USA
Panelists
Karen Moniz, MHA, MT(ASCP)SBB, Technical Director, ICCBBA, USA
Tamara Lengacher, BSc, Director, Quality, NMDP/Be the Match, USA
Mary Grable McLeod, MLS(ASCP) cm SBBcm, SSGB (ASQ), CABP(H), Quality Manager – Blood and Marrow Transplant Cellular Therapy Facility, Stanford Medicine, United States
Session Description
The various formats for CoI identifiers provided by cell therapy manufacturers and how they are used to link multiple collections for a given therapy add to the complexity of tracing these products from vein to vein. To minimize the risk of potential errors, a globally unique standardized Chain of Identity (CoI) identifier, based on requirements collaboratively developed with the Standards Coordinating Body, was published by ICCBBA. This new standard data structure and data element, defined in ISBT 128 Standard Chain of Identity Identifier (ST-028) was published in late 2022. The standard is currently being incorporated into multiple industry software systems. This session will provide information on the new standard and address perspectives from both collection sites and cell therapy manufacturers regarding the benefits of, and barriers to, implementing the standard.
Learning Objectives
Moderator
Lizette Caballero, BS, MLS(ASCP)CM, Clinical Cell Therapy Liaison, Janssen Pharmaceutical Companies of Johnson & Johnson, USA
Panelists
Karen Moniz, MHA, MT(ASCP)SBB, Technical Director, ICCBBA, USA
Tamara Lengacher, BSc, Director, Quality, NMDP/Be the Match, USA
Mary Grable McLeod, MLS(ASCP) cm SBBcm, SSGB (ASQ), CABP(H), Quality Manager – Blood and Marrow Transplant Cellular Therapy Facility, Stanford Medicine, United States
Session Description
The various formats for CoI identifiers provided by cell therapy manufacturers and how they are used to link multiple collections for a given therapy add to the complexity of tracing these products from vein to vein. To minimize the risk of potential errors, a globally unique standardized Chain of Identity (CoI) identifier, based on requirements collaboratively developed with the Standards Coordinating Body, was published by ICCBBA. This new standard data structure and data element, defined in ISBT 128 Standard Chain of Identity Identifier (ST-028) was published in late 2022. The standard is currently being incorporated into multiple industry software systems. This session will provide information on the new standard and address perspectives from both collection sites and cell therapy manufacturers regarding the benefits of, and barriers to, implementing the standard.
Learning Objectives
- Describe the benefits of the ISBT 128 Chain of Identity Identifier and how to become a CoI Identifier issuer.
- Discuss how to develop an approach to defining the scope of a given therapy to be associated with a Chain of Identity Identifier.
- Identify barriers to a coordinated implementation of the standard and develop a path forward.
- ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing (ST-018)
- ISBT 128 Standard Chain of Identity (CoI) Identifier (ST-028)
Lizette Caballero BS, MLS(ASCP)
Clinical Cell Therapy Liaison
Janssen of Johnson & Johnson
Moderator
Clinical Cell Therapy Liaison
Janssen of Johnson & Johnson
Moderator
Mary Grable McLeod, MLS(ASCP) cm SBBcm, SSGB (ASQ), CAB
Quality Manager – Blood and Marrow Transplant Cellular Therapy Facility
Stanford Medicine
Panelist
Quality Manager – Blood and Marrow Transplant Cellular Therapy Facility
Stanford Medicine
Panelist