Standards for Cellular Therapy Services, 11th edition – Portal

The 11th edition of Standards for Cellular Therapy Services (“CT Standards”), effective July 1, 2023, details the latest standards of practice for accredited cellular therapy facilities and includes overarching quality standards as well as specific technical standards.

The Standards Portal allows users to customize their profile based on the activities for which they are accredited and can be rearranged at any time. Standards that do not apply to a user’s profile will appear grayed out to ensure that purchasers are aware of the standards that apply to their facility and those that do not.

The Standards Portal is also fully searchable by key word, chapter, or standard number, allowing users to navigate quickly to the most relevant standards to them at that time. Guidance is provided on how to implement a standard, why it was created, or why a change was made from this edition to the last. Any relevant documentation that would assist users in implementing the standard in question is provided.

Benefits to Users

All links to outside websites and cross references to other standards in the portal are live and appear in popup windows to allow users to be able to see both the standard in question and the linked post. The full edition of the CT Standards (not including any guidance) is printable at any time to ensure that users can take the CT Standards on the go.

Any interim or emergent standards will appear seamlessly in the portal once effective and highlighted.

By purchasing the CT Standards through the AABB Standards Portal (“Portal”), users acknowledge and agree that they will access the Standards solely for their own personal and/or professional use and not distribute, copy, or provide access to the CT Standards for use by any third parties. Furthermore, users will securely maintain their login and password for the Portal. In the event that AABB or its authorized agents discover that users have not complied with these Terms and Conditions of Use, they understand that they will lose all rights to access the CT Standards and will not be entitled to any refund.

Significant changes to the 11th edition include:

• The Cellular Therapies Standards Committee created new Standard 1.2.3.1.1 for completeness. The new standard ensures that the signature method in use in the facility is concordant with those in the country where these standards are being implemented.
• Specifically in Chapter 4 and throughout the edition, the Committee added the concepts of the maintenance of “chain of identity” and “chain of custody” as a part of agreements and records.
• New Standard 4.1.2.4 now requires that facilities involved in an agreement share any nonconformances to the relevant regulatory institutions where appropriate.
• New Standard 4.3.6 requires that suppliers be qualified when cellular therapy services involve more than one facility.
• New Standard 4.5.5.2 now includes the concept of having a qualified interpreter involved in the donor informed consent process where appropriate. This requires that facilities have all the tools necessary to ensure that donors are fully aware of what will occur and what is expected of them.
• New Standard 5.3.2.1 was included to ensure that the collection of outcomes data be done at facility-defined intervals.
• New Standard 5.8.4 was created to ensure that these Standards include a requirement for facilities that use investigational products being approved for use and labeled according to Competent Authority requirements.
• The Committee added new entry 14 Reference Standard 5.8.2A to ensure that products from donors who are CMV positive are identified as such and the product indicates as much on the accompanying label. This ensures that facilities test donors for CMV and label accordingly with these Standards.
• Reference Standard 5.12B now requires HLA-C testing for all allogeneic donors with regard to HLA type where applicable.
• New Standard 7.2.1 requires that facilities perform lookback procedures in the case of an identified nonconformance.

For more information or assistance, please contact:

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Phone: +1.866.222.2498
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Fax: +1.301.951.7150
Email: sales@aabb.org

(2023, AABB)

Effective date: July 1, 2023

Nonmember price: $287

Member price: $197

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)