Standards Rebuild Project

AATB has launched a volunteer-driven initiative to evolve Standards for Tissue Banking into a simpler and more adaptable set of requirements reorganized into a quality systems framework. Known as the “Standards Rebuild Project,” this initiative will involve a two-step evolution into a standard that will establish clearer and more user-friendly requirements and provide the framework for conveying standards and supporting guidance for evolving products and technologies in tissue banking. The Standards for Non-Transplant Anatomical Donation, 2nd edition will undergo a similar process beginning in 2024. This web page will be regularly updated with news and resources as they become available.

This page was last updated on January 16, 2024.

Background

An evaluation of the structure, useability, and applicability of current 14th edition of Standards showed that while the Standards represent a critical repository of information and guidelines that provide the backbone for quality operations in industry, they were in need of thorough evaluation and modernization to improve their flexibility, reduce their overall complexity, and increase their value to members. By creating a modern, resilient, and maximally fit-for-purpose Standards, AATB will be able to accommodate evolutions in technology and regulation and strengthen allied programs (i.e., Accreditation, Education). The Standards Rebuild Project was formally launched with the mission to provide best-in-class Standards through a bold and thoughtful redesign. The Project will be accomplished in two stages represented by the 15th and 16th editions of Standards.

Key Dates

As currently envisioned, a tentative timeline for the Standards Rebuild Project is as follows:

DECEMBER 18, 2023: RELEASE OF THE DRAFT 15TH EDITION AND PRELIMINARY CROSSWALK TO AATB MEMBERS

JANUARY 10, 2024: WEBINAR - "REBUILDING AATB STANDARDS: AN UPDATE AND Q&A ON THE 15TH EDITION"

FEBRUARY 2-25, 2024: COMMENT PERIOD FOR COUNCIL MEMBERS

MARCH - JUNE 2024: DEVELOPMENT OF GUIDANCE FOR ACCREDITED TISSUE BANK TRANSITION

JULY 2024: 15TH EDITION ENTERS A SIX-MONTH PREPARATORY PERIOD

JANUARY 2025: 15TH EDITION COMES INTO EFFECT

The 15th Edition

As part of the Standards Rebuild Project, AATB released the first draft of the 15th edition to all members on December 18. This edition, undergoing restructuring into a new systems framework without introducing new requirements, is designed to support user acclimation. Despite being fully functional within the new framework, its primary role is to serve as an intermediary for users to adapt to the changes. Additionally, AATB supplemented the draft with a preliminary crosswalk, illustrating the transition of text from the 14th to the 15th edition, including any removed text ("preempted") due to duplication or other reasons.

Comment Period
Engagement with AATB members is crucial to refining the draft before its anticipated 6-month preparatory period, starting in July 2024. The outcome of this process is scheduled to come into effect on January 31, 2025. In line with AATB practice, a comment period will be opened to all Council members from February 5-25, 2024. If you are interested in participating in the comment period, it’s important to note that membership in an AATB council is a prerequisite, and you will need to join a council.

The 16th Edition

Based on the 15th edition, the Standards Committee will develop the 16th edition of Standards. The newly restructured document will be evaluated for opportunities to revise and add requirements to ensure that Standards are state-of-the-art and reflective of trends and evolutions in technology, regulation, and industry practice for areas where Standards should change or be prepared to accommodate future changes.

Resources

Frequently Asked Questions (FAQs) Regarding the Standards Rebuild Project
To enhance transparency and responsiveness throughout the process of revising AATB Standards, we are pleased to share insights into the concerns of our stakeholders and our current perspectives on these matters through the FAQs provided here.

View the Standards Rebuild Project FAQs

Webinar: Rebuilding AATB Standards Part 2: An update and Q&A on the 15th Edition

Join us on May 22, 2024, for an exclusive update on the Standards Rebuild Project. Gain insights directly from the coordinators of the program as they discuss the latest developments, including the release of the draft 15th edition for Council comment. Learn about the trajectory for the 15th edition and discover related program activities, including the resources AATB plans to provide to aid in the transition from the 14th edition. Don't miss this opportunity to stay informed and participate in an open Q&A session to address any queries you may have.

Recording: Rebuilding AATB Standards: An Update and Q&A on the 15th Edition

This insightful webinar took place on January 10, 2024 and provided an update on the AATB Standards Rebuild Project and discussed the transition to the 15th edition. The webinar featured a live Q&A session, offering an opportunity for participants to engage directly with our team.
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Recording: Standards Rebuild Process & Update

During this 2023 AATB Annual Meeting Session, AATB staff and project group leaders provided an overview and update on the progress of our restructuring of the AATB Standards in anticipation of the publication of the 15th Edition Standards for Transplant.

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