Sixth Edition of Standards for Molecular Testing Takes Effect

The sixth edition of Standards for Molecular Testing for Red Cell, Platelet and Neutrophil Antigens took effect Jan. 1 and includes several changes and additions. AABB’s Molecular Testing Standards Committee highlighted the following updates:

• New Standard 1.9 requires that all laboratories have processes in place to perform risk assessments for all critical activities in the facility at defined intervals.
• Reference Standards 2.2A, 2.2B, and 2.2C have been expanded to include a third column to the tables focused on "chromosome position," which relates to the chromosome position for the current human reference genome assembly.
• New Standard 3.6.6 requires that laboratories have processes in place to minimize the risk and impact of internal and external data breaches.
• New Standard 5.1.2.1 was created for facilities outside the United States that perform proficiency testing through programs in their region.

The sixth edition is available in the AABB Store in an electronic format, print format, or as a bundle of both versions. A bundle of the sixth edition (in print) and the Guidance for Standards for Molecular Testing for Red Cell, Platelet and Neutrophil Antigens is also available. Organizations interested in adopting the Standards can participate in a complimentary two-week trial of the electronic version of the sixth edition in the Standards Portal.

For those implementing the sixth edition, the Molecular Testing Standards Committee has created a document titled “Significant Changes and Response to Comments Received to the sixth edition of Standards for Molecular Testing for Red Cell, Platelet and Neutrophil Antigens.”

Individuals with questions regarding the Standards should contact standards@aabb.org.