Standards for Immunohematology Reference Laboratories, 12th edition – Portal

The 12th edition of Standards for Immunohematology Reference Laboratories relies on a matrix of quality management system and detailed operational requirements, such as those defining minimum antisera resources.

Significant changes in the 12th edition include:

• New standard 3.9.6 requires all accredited laboratories to have processes in place to minimize the risk of both internal and external data breach. This standard also appears in other sets of AABB Standards.
• New standard 5.1.3.1.1 will require that all laboratories review all package inserts for new materials to ensure that they remain in compliance with associated requirements.
• New standards 5.1.5.2 and 5.1.5.2.1 have been included in the 12th edition to ensure that reagents prepared by the laboratory are used in accordance with the instructions and in line with the current literature.
• Standard 5.2, requiring participation in the American Rare Donor Program has added a new avenue to meet the ARDP requirements, by a combination of shipping seven units to other participating laboratories and screening 500 donors for high prevalence antigens.
• New standard 5.3.6 focuses on compatibility testing ensuring that laboratories do perform this type of testing that they do demonstrate red cell compatibility between patient serum/plasma and donor cells.

Product Features:

The 12th edition of Standards for Immunohematology Reference Laboratories (IRL Standards), effective April 1, 2022, relies on a matrix of quality management system and detailed operational requirements, such as those defining minimum antisera resources.

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 IRL Standards (not including any guidance) is printable at any time to ensure that users can take the IRL Standards on the go.

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

By purchasing the Standards for Immunohematology Reference Laboratories, 12th 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. 

Nonmember price: $199

Member price: $138

For more information or help, please contact:

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Phone: +1.866.222.2498
+1.301.215.6489
Email: sales@aabb.org

(2022, AABB)

Effective date: April 1, 2022

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)