Comment Period Opens for Proposed 2nd Edition of Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusions

The proposed second edition of Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusions is now available for public comment until Nov. 24. 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 advancements in science and technology. Some of these notable 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 3.2.3.1 requires all equipment to be validated where it will be put in use as a means of ensuring that equipment used in the field is validated appropriately.
• 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.
• Reference Standard 5.1.9A has been updated to include storage, transportation and expiration requirements for dried plasma.

The AABB Prehospital and Out-of-Hospital Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the second 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.