Updated Quality Systems Essentials

AABB's updated Quality Systems Essentials is the next step in the evolution of quality for the blood and biotherapies field, as well as a continuation of our efforts to ensure the highest level of quality and safety for all donors and patients.

Frequently Asked Questions about the Updated Quality Systems Essentials

Will the updated QSEs replace the current Quality System Essentials in all sets of AABB Standards?

Yes! The updated QSEs language has been finalized and approved, is being incorporated into all sets of Standards that have been created since the spring of 2023. Note, the change will not occur retroactively.

Will the updated QSEs be a stand alone document?

At this time there is no plan to have a separate accreditation associated with the updated QSEs.

What's New? High Level Changes to the 2023 Updated Quality Systems Essentials

• Standards are now written in the active voice.
• A requirement once stated is not repeated. (Policies, processes, and procedures appear once.)
• Standardized chapter structure, including:
  • A brief description at the start of each chapter
  • Objective evidence to support implementation
  • Key terms that relate to the content of the chapter
  • Record retention requirements included at the end of each chapter

Why Now?

• It has been over 20 years since the previous full scale update to AABB's Standards Program. In that time, updates to the QSEs have been done incrementally.
• Changes are in response to member needs, as indicated in a Spring 2021 survey.
• Updates are particularly beneficial to facilities with multiple accreditations (uniformity of language and numbering).
• Innovative quality systems help to advance the fields of transfusion and biotherapies.
• Updates to make process easier.

History of Quality at AABB

Quality concepts have been at the heart of every edition of Standards that AABB has released since 1958 and, in that time, they have evolved from a system of safety and accuracy checks into a quality system that serve as the keystone to the work of transfusion medicine professionals throughout the world.

The most visible step in AABB’s quality evolution occurred in 1997 with the release of Association Bulletin #97-04, (released August 1, 1997), which introduced 10 elements known as the AABB Quality Systems Essentials. These QSEs make up the elements of a quality program, which all AABB-accredited facilities were required to implement by January 1, 1998.

The intent of the quality program as detailed in AB 97-04 was to ensure the consistent application of quality principles to operational areas within an organization. For this reason, AABB began to publish its Standards using the QSEs as chapter headings, with operational activities nested within a quality framework.

Since the quality system essentials were introduced in 1997, the quality language and quality system concepts in AABB Standards have evolved through incremental changes, typically introduced by one set of Standards and then implemented in the others shortly thereafter. For instance, the requirement to collect and evaluate quality indicator data was first introduced in the Standards for Perioperative Autologous Blood Collection and Administration and then subsequently included in all sets of Standards that followed.

Background and Research Conducted

• Spoke with quality experts in AABB’s community, outside AABB, seasoned quality experts, new quality members, experienced and new members targeted at facilities of varying sizes.
• Conducted three separate targeted reviews on language and flow.
• Presented to AABB Standards and Accreditation Program Committees and AABB Board of Directors.
• Feedback incorporated as needed.