AABB is launching a new iteration of its internationally renowned Standards and Accreditation program: the new Quality Systems Framework. The new program will officially launch in early 2022 and represents the first significant update of AABB’s Standards and Accreditation Programs in more than two decades.
The Quality Systems Framework will include new initiatives to help ease the accreditation process for facilities, while promoting consistency across all AABB standards and accreditation activities. The program also incorporates new facets to further advance donor and patient health and safety.
Ahead of the official launch, AABB is asking members of the blood and biotherapies community to review the proposed Quality Systems Framework and share feedback, not only on its content but its tone and flow.
Next Generation of Standards and Accreditation
AABB has been developing Standards that promote patient safety and quality for the blood and biotherapies field since 1957. For decades, AABB has been known as a leader in advancing Standards that combine internationally accepted quality management system essentials with technical requirements that help to advance quality and ensure optimal donor and patient safety. These Standards form the basis by which facilities achieve AABB accreditation.
The new Quality Systems Framework is designed as a further advancement of AABB’s Standards and Accreditation programs, which was introduced in 1997 and has been enhanced intermittently since then. “We believe that the Quality Systems Framework represents a key advancement in the evolution of quality for the blood and biotherapies field,” said Christopher Bocquet, AABB’s senior director of Standards and Quality Initiatives. “The Quality Systems Framework is also an important continuation of our efforts to always ensure the highest level of quality and safety for all donors and patients.”
Meeting Member Needs
AABB began developing the Quality Systems Framework as a response to the evolving needs of its members. As technology and science have expanded, so too has the need for advancements in Standards.
AABB conducted a survey in Spring 2021 to better understand members’ needs and how to address those needs as it developed the next iteration of its Standards Program. In addition, AABB conducted thorough research to help develop an optimal Standards program and how to ensure the program would meet the needs of the field. Throughout the research, AABB staff spoke with quality experts in the AABB community, as well as those working in other fields and disciplines. AABB staff also interviewed quality experts and employees of AABB-accredited facilities of varying sizes concerning this revision.
Many of the key aspects of the new system are based on information gleaned during this research process.
As AABB began developing the Quality Systems Framework, three separate targeted reviews on language and flow were also conducted; this was to ensure the quality system would help to ease the process associated with meeting the Standards for employees of AABB-accredited facilities.
“AABB’s new Quality Systems Framework template brings forward an evolved and streamlined approach,” said Patrick Ooley, corporate director of Quality at Vitalant. “The new template will bring consistency among all AABB Standards disciplines and is designed to enhance user understanding as well as interpretation by AABB assessors. The framework can be easily adapted to help users build or enhance their own quality system.”
Among the many updates in the Quality System Framework, the program is designed to streamline the Standards and Accreditation process. This will be particularly beneficial for facilities with multiple accreditations.
Additional updates and benefits include:
- All Standards are now written in the active voice.
- There will be uniformity of language and numbering across all AABB standards.
- A requirement once stated is not repeated. (Policies, processes, and procedures appears once.)
- Each chapter begins with a brief description of the content, objective evidence to support implementation, and key terms that relate to the content of the chapter.
- Record retention requirements are included at the end of each chapter.
AABB asks that members of the blood and biotherapies community review the draft of the Quality Systems Framework and provide feedback by Nov. 22. Individuals seeking additional information may contact Standards@aabb.org.