Comment Period Opens for Proposed 14th Edition of Standards for Immunohematology Reference Laboratories

April 25, 2025

The proposed draft Standards for Immunohematology Reference Laboratories, 14th edition, is available for public comment until June 24. A summary memo that accompanies the proposed IRL Standards provides a comprehensive description of the additions and edits in the draft.

Some of these significant changes include:

Proposed new Standards 1.9 and 1.9.1, which require that accredited laboratories contact AABB when a change could impact their accreditation status and when they are subject to a regulatory enforcement action from their relevant competent authority.
Proposed new Standard 3.8, which requires that accredited laboratories have active monitoring of their technology infrastructure, including risk-based monitoring and testing at defined intervals.
Proposed new Standard 5.1.2.5, which requires that laboratories have a defined process to detect titration testing errors by performing controls each day that said testing is performed.

The Immunohematology Reference Laboratories Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the 14th 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.