Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 3rd edition

The 3rd edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards) contains requirements for facilities using molecular methods to predict blood group antigens on red cells, platelets, and neutrophils, as well as quality system requirements, operational standards, and a detailed list of inventory resources necessary for the identification of targeted nucleotides that encode these antigens.

Organized according to the Quality System's Essentials quality template, the MT Standards addresses operational aspects such as test methods including Restriction Fragment Length Polymorphism Testing, DNA Testing for Nucleotide Sequence Determination or Single Nucleotide Polymorphism (SNP) Analysis, and DNA Array. The guiding principle of this document is to be consistent with available scientific information while focusing on patient advocacy and optimal care for donors. These MT Standards represent the minimum requirements under which a laboratory specializing in molecular testing should operate.

Significant changes:

• New standard 1.4 requires accredited laboratories to alert AABB of any initial appointments or changes to the laboratory director position.
• New standard 1.5 requires accredited laboratories to alert AABB when they cease or resume on site testing within 30 days of the occurrence.
• New standard 3.3 provides laboratories flexibility in determining what equipment will be deemed critical and which are not.

Product Features:

The 3rd edition of MT Standards, effective October 1, 2016, details the latest standards of practice for facilities using molecular methods to predict ABO, Rh, and other blood group antigens on red cells, platelets, and neutrophils. The Standards Portal allows users to customize their profile based on the activities for which they are accredited and can be rearranged at any time. Standards that do not apply to a user's profile will appear grayed out to ensure that purchasers are aware of the standards that apply to their facility and those that do not.

The Standards Portal is also fully searchable by key word, chapter, or standard number, allowing users to navigate quickly to the most relevant standards to them at that time. Guidance is provided on how to implement a standard, why it was created, or why a change was made from this edition to the last. Any relevant documentation that would assist users in implementing the standard in question is provided.

All links to outside websites and cross references to other standards in the portal are live and appear in popup windows to allow users to be able to see both the standard in question and the linked post. The full edition of the MT Standards (not including any guidance) is printable at any time to ensure that users can take the MT Standards on the go.

Any interim or emergent standards will appear seamlessly in the portal once effective and highlighted.

By purchasing the Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 3rd edition ("Standards") through the AABB Standards Portal ("Portal"), users acknowledge and agree that they will access the Standards solely for their own personal and/or professional use and not distribute, copy or provide access to the Standards for use by any third parties. Furthermore, users will securely maintain their login and password for the Portal. In the event that AABB or its authorized agents discover that users have not complied with these Terms and Conditions of Use, they understand that they will lose all rights to access the Standards and will not be entitled to any refund.

For more information please contact:

AABB Customer Support
8101 Glenbrook Road
Bethesda, MD 20814
Phone: +1.866.222.2498
+1.301.215.6489
Fax: +1.301.951.7150
Email: sales@aabb.org

(2016, AABB)

Effective date: October 1, 2016