Comment Period Opens for Proposed 6th Edition of Standards for Molecular Testing for Red Cell, Platelet and Neutrophil Antigens

May 06, 2022

The proposed draft sixth edition of Standards for Molecular Testing for Red Cell, Platelet and Neutrophil Antigens, is now available for public comment. The comment period begins Friday, May 6, and will conclude on Tuesday, July 5.

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 the notable changes include:

  • The Molecular Testing Standards Committee has added new Standard 1.9 to the proposed edition requiring that laboratories perform risk assessments at defined intervals for all critical activities.
  • Reference Standards 2.2A, 2.2B and 2.2C include a new column requiring laboratories to maintain “chromosome position” for all DNA resources that relates to chromosome position from the current human reference genome assembly.
  • Proposed new Standard 5.1.4.1.1 requires that laboratories repeat any failed test runs as a part of quality control.

The 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. The draft is available on the front page of the AABB website.