Comment Period Opens for Proposed 35th Edition of Standards for Blood Banks and Transfusion Services

The proposed Standards for Blood Banks and Transfusion Services, 35th edition, is available for public comment through Aug. 12. A summary memo that accompanies the proposed BB/TS Standards provides a comprehensive description of the additions and edits in the draft. 

Some of these significant changes include:

• New Standards 1.9 and 1.9.1 require that accredited organizations contact AABB in cases where they are under organization by their competent authority.
• New Standard 3.5.4.1 clarifies that when a known piece of equipment is the root of a nonconformance, not all similar equipment has to be reviewed.
• New Standard 3.7 requires that laboratories monitor their critical technology infrastructure and that they function as expected. This standard requires that there are defined checks to monitor that technology is working as intended and expected.
• New Standard 5.7.4.20 requires that pathogen-reduced cryoprecipitated fibrinogen complex be prepared per the manufacturer’s written instructions.

The Blood Banks/Transfusion Services Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the 35th 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.