Comment Period Opens for Proposed 6th Edition of Standards for a Patient Blood Management Program

The proposed draft Standards for a Patient Blood Management Program, sixth edition, is available for public comment through Nov. 10. A summary memo that accompanies the proposed standards provides a comprehensive description of the additions and edits in the draft.

As with every new edition of proposed standards, there are updates in this edition reflecting advances in science and technology. Some of the notable updates in this proposed draft 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 3.6 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 Standards 3.6.1 – 3.6.4.1 focus on the use, risk management, verification of output and monitoring of artificial intelligence in the accredited facility.
• New Standard 5.3.3 focuses on the need to have a specific informed consent process for patients lacking decisional capacity.
• New Standard 7.4.2 ensures that programs review all data concerning any deviations, nonconformances and adverse events used to determine if there are any potential trends that could lead to further nonconformances.

AABB’s Patient Blood Management Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the sixth 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.