Back to Bundle: Standards for Blood Banks and Transfusion Services, 32nd edition - Print and Guidance
The 32nd edition of Standards for Blood Banks and Transfusion Services (BBTS Standards) details the latest standards of practice in blood banking and transfusion medicine. As in the past, each chapter heading represents one of the Quality System Essentials and the quality standards are supplemented by technical requirements. The effective date of this edition is April 1, 2020.
Significant changes in the 32nd edition include:
- New standard 1.4 will require that facilities have policies, processes and procedures to address the operational continuity in the event that operations are put at risk. Along with this standard, new standard 1.4.1 requires that facilities have a policy to address product inventory shortages.
- Standard 5.2.1, #5 has been edited to include requiring mitigation strategies regarding the risk of post donation related iron deficiency.
- Standard 5.2.2 has been expanded to require that when parental permission is required to donate, that the parent or legally authorized representative is made aware of the potential adverse effects of donation.
- Standards 5.8.5, 5.8.6, 5.8.7 and reference standards 5.1.6A and 5.4.1A have been expanded to include the requirement to conduct Zika Virus RNA testing and nucleic acid testing for Babesia. However, NAT for Babesia is NOT required to be performed if all transfusable components from the donation are prepared using FDA approved pathogen reduction technology or collection does not occur in one of the states listed in the May 2019 FDA Guidance.
- Standard 5.19.7 includes new subnumber 2, requiring that the BB/TS have a policy regarding indications the use of cold stored platelets, specifically in trauma settings.
Guidance for Standards for Blood Banks and Transfusion Services, 32nd edition, includes verbatim requirements from the BBTS Standards interspersed with guidance. Language from the BBTS 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 32nd Edition Blood Bank/Transfusion Service Standards Committee has chosen to focus Guidance for Standards for Blood Banks and Transfusion Services on those issues that may require additional context and/or examples to assist in attaining compliance with the Standards.
(2019, AABB, softcover, 128 pages, and 2020, AABB, softcover, 128 pages)
Effective date: Effective date: April 1, 2020
View Table of Contents (pdf)
View Preface (pdf)
View Sample Pages (Standards) (pdf)
View Sample Pages (Guidance) (pdf)