Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 6th edition – Portal

The 6th 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.

Product Features:
The 6th edition of MT Standards, effective January 1, 2023, details the latest standards of practice for facilities using molecular methods. 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.

New Benefits to Users:
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, 6th 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.

Significant changes to the 6th:

• 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 breach.
• New Standard 5.1.2.1 was created for facilities outside the United States that perform proficiency testing through programs in their region.

(AABB, 2022, digital product)
Effective date: January 1, 2023
Nonmember price: $159
Member price: $139

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Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)