BUNDLE Standards for Immunohematology Reference Laboratories, 13th ed – Print and Guidance

Product Code: 244025

ISBN: 978-1-56395-484-9

The 13th 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 13th edition include:

The updated Quality Systems Essentials template has been incorporated into the 13th edition, including updated language and new sections on key concepts and key terms and examples of objective evidence.
Standard 5.1.1.1 has been updated to focus specifically on testing processes and not testing procedures.
New Standards 5.1.10.1.1 – 5.1.10.1.3 address proficiency testing referrals, associated communications, and notifications to CMS.
New subnumber 3 has been added to Standard 5.2 creating a new path for conformance with American Rare Donor Program participation by screening at least 1000 donors for IgA deficiency.

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.

(2024, AABB, softcover, ISBN 978-1-56395-484-9, and 2022, AABB, softcover)

Effective date: April 1, 2024

Member price: $231
Nonmember price: $336