Reminder: AABB Accepting Feedback on Proposed 34th Edition of BB/TS Standards
July 24, 2023
The proposed draft Standards for Blood Banks and Transfusion Services, 34th edition, is available for public comment through Aug. 15.
A comprehensive description of the many additions and edits in the draft are provided in a summary memo that accompanies the proposed BB/TS Standards.
The proposed 34th edition of BB/TS Standards incorporates the updated quality systems essentials that form the basis for all sets of AABB Standards. The updated quality systems essentials provide a one page piece of guidance before the beginning of each of the 10 chapters. This guidance includes:
- A description of the chapter and what the standards therein cover.
- A list of key terms that mirror the content of the chapter and that should be kept in mind when reviewing the standards.
- A list of key objectives that an assessor could look for during an onsite assessment, however, this list is not comprehensive.
Users should note that these are not requirements that members will be held against. Rather, they are tools to assist users in their understanding of the content of the chapter.
Some of these significant changes in the proposed 34th edition include:
- Each chapter now concludes with the record retention table for those standards. A comprehensive record retention table still exists in Chapter 6.
- Proposed new Standards 18.104.22.168, 22.214.171.124 and 126.96.36.199 have been added to the edition to address requirements set forth by the Centers for Medicare and Medicaid Services concerning proficiency testing referrals and what is and is not currently allowed as until the results of proficiency testing are complete and submitted.
- Proposed new Standard 5.10.1 has been added to the edition to require that facilities have the current version of the Circular of Information for the Use of Human Blood and Blood Components available.
- Proposed new Standard 5.15.6 requires that red cells in platelets be ABO-compatible with the recipient’s plasma and be crossmatched as necessary.
- Reference Standard 5.4.1A has been updated to include the emergent standards to the 33rd edition of Blood Banks and Transfusion Services concerning the new FDA guidance that addresses the evaluation of donor eligibility using individual risk-based questions to reduce human transmission of HIV.
The Blood Banks and Transfusion Services Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the 34th edition are in the proposed phase and will be finalized after the comment period has concluded. The Committee will review all comments submitted and provide a summary document that describes the committee’s rationale for its final decisions.