BUNDLE Standards for Immunohematology Reference Laboratories, 12th ed – Print and Guidance

This bundle provides access to Standards for Immunohematology Reference Laboratories, 12th edition, and Guidance for Standards for Immunohematology Reference Laboratories, 12th edition. The 12th edition of Standards for Immunohematology Reference Laboratories (IRL Standards) 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.

Guidance for Standards for Immunohematology Reference Laboratories includes verbatim requirements from the IRL Standards interspersed with guidance. Language from the IRL Standards is presented; when there is appropriate guidance for that standard, the guidance language follows the standard with the heading “Guidance.” This format allows the reader to see both the requirement and the associated guidance side by side.

Please note that there is no guidance for some standards. The Immunohematology Reference Laboratories Standards Committee has chosen to focus Guidance for Standards for Immunohematology Reference Laboratories on those issues that may require additional context and/or examples to assist in attaining compliance with the IRL Standards.

(2022, AABB, softcover, 61 pages, ISBN 978-1-56395-441-2, and 2022, AABB, softcover, 65 pages)

Effective date: Effective date: April 1, 2022

Nonmember price: $320

Member price: $220

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)