OPEN FOR PUBLIC COMMENT: United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128
ICCBBA and the ATAG (Americas Technical Advisory Group) are seeking public comment on a new version 4.0.0 of the document IG-002 United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128. The significant changes made to the document are captured in the version control table found in section 1.7. Some of the changes include:
Table 5 - New class-modifier combinations were added to the table.
Section 4.2.1.2 and Section 4.3.1.4 - The use of the “D” collection type in the Product Code for Directed, Eligible for Crossover units will not required to be used and will remain optional.
Table 7 - New attributes were added to the table.
Section 7.5 - The lower left quadrant Product Code label examples from section 7.5 were omitted and added to an addendum. It is also being suggested that some of the upper right quadrant ABO/Rh label examples be added to the addendum, in particular those that do not have accompanying text with the example.
Section 7.8.2 - Guidance on Reconstituted Red Blood Cells were expanded.
Section 7.8.11 – The Technical Bulletin document TB-015 (Bacterial Testing Strategies for Platelets - US Guidance) was incorporated into the section. TB-015 will be retired in the future when IG-002 v4.0.0 has been published.
Section 7.8.12 - The Technical Bulletin document TB-003 (Apheresis Platelets - US Guidance) was incorporated into the section. TB-003 will be retired in the future when IG-002 v4.0.0 has been published.
Updated CFR references throughout the document.
The labeling guidance for bacterially monitored Pooled Platelets has been revised.
There were many other minor changes made throughout the document and reviewers are encouraged to comment on the entire draft document. All public comments will be reviewed by ICCBBA and ATAG prior to acceptance.
The draft for IG-002 v4.0.0 can be found here. A mark-up version of the draft document is available upon request.
Please email your comments to IG002.comments@isbt128.org. Comments will be accepted through May 31, 2022.