This combination provides two ways to access the 11th edition of Standards for Cellular Therapy Services (CT Standards): print and electronic.
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.
Significant changes to the 11th edition include:
- The Cellular Therapies Standards Committee created new Standard 188.8.131.52.1 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 184.108.40.206 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 220.127.116.11 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 18.104.22.168 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.
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.
For more information or assistance, please contact:
AABB Customer Support
4550 Montgomery Ave
Suite 700, North Tower
Bethesda, MD 20814
(AABB, 2023, softcover, 187 pages & AABB, 2023, digital product)
Effective date: July 1, 2023
Nonmember price: $459
Member price: $315
View Table of Contents (pdf)
View Preface (pdf)
View Sample Pages (pdf)