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 through the FAQs provided here. These FAQs will be updated as necessary to ensure you have the most up-to-date information.

Frequently asked questions (FAQ) regarding the AATB Standards Rebuild Project, last updated July 29, 2024.

 

 

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 15th edition was driven by a steering committee and working groups of volunteers from across AATB’s membership. It is a version that is restructured into a new quality systems format but does not contain any new requirements resulting from the project. This approach was intended to allow users to adapt to the new structure without having to comply with changing requirements. 

 

Q2. 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 exercises aimed at 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.  

 

Q3. Will AATB provide training on the 15th edition? 

Yes. Details will be made available about forthcoming training as it is scheduled. 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. 

 

Q4. 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.  

 

Q5. What are the plans for the 16th edition?

As the Rebuild Project progressed, it was recognized that the 15th edition represents a major transformation in Standards and establishes a solid platform for the continuous improvement of Standards, including opportunities to ensure that Standards are state-of-the-art and reflective of trends and evolutions in technology, regulation, and industry practice. The plans for the 16th edition include a more targeted approach to development of next-generation standards and will not result in its own full-scale “rebuilding” of Standards as was seen with the 15th edition. This development will follow the typical revision process.

 

Q6. 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. More detailed communication outlining these goals will be provided to members as they are developed.