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AABB22: 'Ask the Standards' Highlights Recent Changes to BB/TS Standards, Proposed Updates to CT Standards

November 07, 2022

This year’s “Ask the Standards” session brought together experts from two AABB Standards Committees to discuss new and changed standards and answer questions submitted in advance and during the session.

Susan Noone, MPH, CSQ(ASQ), regional director, Central Coast, at Vitalant and chair, Work Group 3, of AABB’s Blood Banks/Transfusion Services (BB/TS) Standards Committee, began the session with a focus on the 33rd edition of BB/TS Standards, which took effect April 1.

Noone described the changes to the 33rd edition and provided the Committee’s rationale for these changes. She also outlined emergent standards issued after April 1, including:

  • The edition of an emergent standard related to variant Creutzfeldt-Jakob disease (vCJD), issued July 29, 2022, via Association Bulletin #22-02. This emergent standard removed requirements to defer donors who were considered at risk for transfusion transmission of vCJD, updated deferrals concerning a family genetic history of CJD and updated deferrals for individuals who have received cadaveric pituitary growth hormone.
  • Revisions to existing Standard 5.7.2.1.1 and the creation of new Standard 5.7.2.1.1.1 related to sterile weld, which the Committee outlined in Association Bulletin #22-04.

Kate Brown, PhD, senior director of science at Generate Life Sciences and chair of the Cellular Therapy (CT) Standards Committee, provided an update on the development of the proposed 11th edition of the CT Standards. Brown outlined proposed changes to 14 existing standards and described 16 proposed additions to the CT Standards, along with rationale for each.

The CT Committee received 36 comments during the pre-comment period and 51 comments during the public comment period. She also emphasized that these changes are not final and that Committee members are current reviewing comments on the proposed 11th edition. The 11th edition of CT Standards will take effect July 1, 2023.