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. These FAQs will be regularly updated to ensure you have the most up-to-date information.

Frequently asked questions (FAQ) regarding the AATB Standards Rebuild Project, last updated December 15, 2023.

 

 

Q1. Why was this project undertaken? How did AATB approach it? 

An evaluation of the structure, useability, and applicability of the 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 the 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 more 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, etc.)  

 

The Standards Rebuild Project was formally launched with the mission to provide best-in-class Standards through a bold and thoughtful redesign. The Project is being accomplished in two stages represented by the 15th and 16th editions of Standards. The 15th edition was driven by a steering committee and working groups of volunteers from across AATB’s membership. It will be a version that is restructured into a new quality systems format but will not contain any new requirements. This approach will allow users to adapt to the new structure without having to comply with changing requirements. The 16th edition will be created by AATB’s Standards Committee from the 15th after a thorough content review and may incorporate new requirements. Additional AATB members may be invited to join special workgroups alongside the Standards Committee, ensuring a comprehensive representation of knowledge and experience from our membership. 

 

Q2. What are the timelines for release of the 15th and 16th editions? 

The 15th edition will undergo a comment period in February 2024, be published for implementation in July 2024, and become effective in January 2025. The 16th edition is expected to undergo a comment period in February 2025, be published for implementation in July 2025, and become effective in January 2026. 

 

Q3. How can members participate in the revision process? 

Engagement with and feedback from AATB members is crucial to developing the best possible 15th and 16th editions of Standards. Here are some of the ways in which you can participate: 

Review the draft. A primary goal of releasing the draft well ahead of the comment period is to give members additional time to review it. Please take some time to familiarize yourself with the new structure and style. Compare it to the 14th, using the crosswalk as a guide. Think about what will be required to implement and use the new version in your organization. Consider starting a review group within your team. Starting now should help inform your opinion about the draft, suggest possible feedback, and get you started thinking about implementation. If you did not receive a draft of the 15th Edition of Standards for Tissue Banking, please email standards@aatb.org. 

Attend available webinars. Register for and join the January 10 webinar, "Rebuilding AATB Standards: An Update and Q&A on the 15th Edition" (and others, as made available) to learn from AATB about the rebuild project, how the draft came to be, and how it will be implemented. Ideally, come prepared with questions and comments based on your review of the draft. 

Participate in the comment process. The key component of stakeholder engagement will be the comment period, which will be opened to all Council members from February 5-25, 2024. Membership in an AATB council is a prerequisite, so you will need to join a council. There is no cost or risk to do so.  

Look for additional announcements. We will be offering additional resources and opportunities for engagement as the project progresses through 2024, so please watch for related announcements. 

 

Q4. How does AATB plan to support accredited tissue banks’ need for change control during the transition to the 15th edition? 

We recognize that the extensive revision to Standards may require a significant amount of change control within an organization’s quality system. To help support this need, in early 2024, we are planning to conduct a tabletop exercise dedicated to change control. The intention is to identify best practices around systematically adapting an organization’s quality system and SOP manual to a new version of Standards. The output of this exercise will be shared with accredited banks. 

 

Q5. How does AATB plan to ensure continuity in accreditation inspections during the transition to the 15th edition? 

A recurring request received during the Standards Rebuild Project is to make sure that the transition from the 14th to the 15th editions is seamless with regard to Accreditation inspections. To that end, we are planning to conduct at least one “mock inspection,” during which we will perform a live inspection of a tissue bank using the new Standards to identify any challenges in applying those requirements. Learnings from this activity will help the Accreditation program adapt its practices as necessary and train and support inspectors during the transition.  

 

Q6. Will AATB provide training on the 15th edition? 

Yes. As the release of the 15th edition gets nearer, details will be made available about forthcoming training. It is anticipated that the same training on the content of Standards will be provided to both members and AATB Accreditation inspectors to promote a common understanding of requirements.  

 

Q7. Is there a risk that some more detailed and technical content currently in the 14th edition will be removed? How will AATB ensure that such content is not lost? 

There is the potential to remove some more detailed content from Standards as they transition to a systems-based format. The purpose of this is to enable greater flexibility so that users can establish more organization-specific and data-driven processes and policies. We are committed to ensuring that such content continues to be made available. This content will evolve along with the Standards to ensure that accredited tissue banks continue to have the resources they need.  

 

Q8. Will regular revisions of Standards continue during the rebuilding process? How will they be incorporated? 

The Standards Committee continues to work in parallel on regular updates to Standards as needs are identified. Although we have committed not to create new requirements as part of the 15th edition, these parallel revisions might result in new requirements. All routine (non-rebuild) revisions to Standards will continue to follow the current notice-and-comment process and will appear for comment in the format in which they will appear when published for implementation, although they will be presented for comment separately with their own briefing describing the revision. If they are published for implementation concurrent with the 15th edition, they will be merged with that document to represent the version that ultimately will become effective. 

 

Q9. Will the Standards for Non-transplant Anatomical Donation also go through a rebuilding process? 

Yes. Building on the insights gained from the reconstruction of the 14th edition of Standards for Tissue Banking, we will commence the development of the project plan for the 2nd edition of Standards for Non-transplant Anatomical Donation. This initiative will be undertaken collaboratively with our NADO Council leadership. The objectives for the non-transplant standard reconstruction will align with those established for our transplant standards, and a more detailed communication outlining these goals will be provided to members in 2024.