SUMMARY OF RECENT ACTIVITY

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The ICCBBA Board has approved a new ATAG Chairperson, Kathleen Hopping. Kathleen has participated in ATAG as a Technical Expert and also Chaired one of the subcommittees, and will now serve as the group’s Chairperson for a three-year term beginning in 2023. Suzanne Butch will conclude her term as Chair of ATAG at the end of 2022. ICCBBA thanks Kathleen for agreeing to serve as ATAG chair and thanks Suzanne Butch for her many years of excellent service in leading the group.

 

The IG-002 subcommittee addressed the public comments received for the draft IG-002 United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 v4.0.0 document. The comments were incorporated and the latest draft version was sent to the FDA for their official review.

 

The group is discussing ICCBBA's potential role in developing and managing standardized inventory status codes and definition to support traceability and hemovigilance. Many countries do not have a single, integrated blood system or robust hemovigilance systems. Standardized status codes (e.g., inventory status codes; recipient adverse events codes; donor adverse events reaction codes) can be utilized with blood product traceability information to provide real-time inventory and hemovigilance support and could be used in conjunction with a national inventory system. Uniform definitions would aid in clean data collection across sites. Industry user input is needed to determine what information or status codes need to be tracked.

 

ICCBBA identified potential updates to IG-025 Implementation Guide: US Guidance on Printing Text Associated with Red Cell Antigen as a result of the new FDA Guidance for Industry: Labeling of Red Blood Cell Units with Historical Antigen Typing Results. ICCBBA will include a reference to the FDA Guidance document in the References section of IG-025. ICCBBA publications related to the electronic transfer of information will also be added to the References section of IG-025.

 

ICCBBA published the following electronic messaging documents: ST-020 – ISBT 128 Standard for XML Electronic Messaging; ST-026 – ISBT 128 Standard for the Medical Products of Human Origin (MPHO) Unique Identifier; ST-027 – ISBT 128 Dictionary of Standard Data Elements; IG-048 – Implementation Guide: MPHO Unique Identifier.

 

ATAG plans to meet on a quarterly basis and engage its members on a more frequent basis. ICCBBA has incorporated the use of Loomio to facilitate asynchronous TAG discussions. Members are encouraged to inform ICCBBA of new user needs at any time.

 

ICCBBA recognizes the following members for going above and beyond to support ATAG’s recent activities:

• Suzanne Butch - ATAG Chair

       Thank you for your years of leadership and service as the ATAG Chair.

• Kathleen Hopping - ATAG Subcommittee Chair

       Thank you for your initiative in leading the US Platelets Subcommittee toward a nationwide solution for labeling bacterially

       monitored platelets.

• Maria Locher - ATAG Subcommittee Chair

       Thank you for your role as Chair of the IG-002 Subcommittee and the group’s important work in updating the US

       Consensus Standard.

• Robin Wilkinson - ATAG Technical Expert

       Your extra efforts in thoroughly reviewing the IG-002 US Consensus Standard were very much appreciated.

 

ICCBBA also thanks all ATAG committee members for their continued participation and valued support.

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