This combination provides the 11th edition of Standards for Cellular Therapy Services (CT Standards) and the Guidance for Standards for Cellular Therapy Services.
The 11th edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.
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.
Guidance for Standards for Cellular Therapy Services includes verbatim requirements from the CT Standards interspersed with guidance. Language from the CT Standards is presented; when there is appropriate guidance for that standard, the guidance language follows the standard with the heading “Guidance.” This format allows the reader to see both the requirement and the associated guidance side by side.
Please note that there is no guidance for some standards. The Cellular Therapy Standards Program Committee has chosen to focus Guidance for Standards for Cellular Therapy Services on those issues that may require additional context and/or examples to assist in attaining compliance with the Standards.
(2021, AABB, softcover, 187 pages, and 2023, AABB, softcover, 131 pages)
Effective date: July 1, 2023
Nonmember price: $459
Member price: $315
View Table of Contents (pdf)
View Preface (pdf)
View Sample Pages - Standards (pdf)
View Sample Pages - Guidance (pdf)