Back to BUNDLE Standards for Immunohematology Reference Laboratories, 11th ed – Print and Guidance for Standards for Immunohematology Reference Laboratories, 11th ed – Print
The 11th 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 11th edition include:
- New standard 1.6 requires that facilities have policies, processes and procedures to address continuity in the event that operations are at risk. This would not include inventory resource levels, and not what would be considered a disaster or emergency.
- The inventory resource requirements in reference standards 2.2A and 2.2B have been adjusted with the movement of over 20 resources that previously appeared in reference standard 2.2A to 2.2B. Accredited laboratories will now have to reach 100% for reference standard 2.2A and 50% of reference standard 2.2B.
- New subnumber 11 has been added to standard 5.3.2 which requires that cold reactive antibodies are now a required serologic capability to ensure that laboratories have processes to investigate antibodies reacting at various phases.
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 Standards.
(2019, AABB, softcover, 58 pages, and 2019, AABB, softcover, 65 pages)
Effective date: Effective date: July 1, 2020
View Table of Contents (pdf)
View Preface (pdf)
View Sample Pages (Standards) (pdf)
View Sample Pages (Guidance) (pdf)