Standards for Immunohematology Reference Laboratories, 12th Edition – Print

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.

(2022, AABB, softcover, 61 pages, ISBN 978-1-56395-441-2)

Effective date: April 1, 2022

Nonmember price: $199

Member price: $138

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)