Comment Period Opens for Proposed 12th Edition of Standards for Immunohematology Reference Laboratories

May 28, 2021

The proposed draft Standards for Immunohematology Reference Laboratories, 12th edition, is now available for public comment. The comment period begins today, May 28, and will conclude on July 27.

A comprehensive description of the many additions and edits in the draft is provided in a summary memo that accompanies the proposed Standards. Some of these significant changes include: 

  • Proposed new Standard 3.9.6 requires that laboratories have processes in place to minimize the impact of internal or external data breaches. This addition ensures that the standards remain consistent with other AABB standards.
  • Proposed new Standard 5.1.3.1.1 requires that laboratories perform a comparison with manufacturer’s instructions when new materials are received to ensure that they remain in compliance with the existing requirements.
  • Proposed new Standards 5.1.5.2 and 5.1.5.2.1 require that laboratories that prepare their own reagents review relevant instructions or publications to ensure the safest possible product. Relevant publications could include the AABB Technical Manual or Judd’s Methods.
  • Proposed Standard 5.2 has included a third option to participate in the American Rare Donor Program, allowing for a combination of shipping at least seven units to other laboratories and screening at least 500 donors for high-prevalence antigens.

The Immunohematology Reference Laboratories Standards Committee encourages all interested individuals to submit comments within the next 60 days. The standards in the 12th edition are currently 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. The draft is available on the front page of the AABB website.