BUNDLE: Standards for Cellular Therapy Services, 10th edition and Guidance for Cellular Therapy Services - Print

This combination provides the 10th edition of Standards for Cellular Therapy Services (CT Standards) and the Guidance for Standards for Cellular Therapy Services.

The 10th edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.

Significant changes to the 10th edition include:

• New standards 1.5 and 1.5.1 require that accredited cellular therapy facilities perform assessments of risk related to the potential introduction of contamination.
• New standard 4.5.2.1 requires that accredited cellular therapy facilities identify vulnerable donor populations who would require access to a donor advocate prior to giving consent.
• Standard 5.12.2.10 has been edited to require that facilities have policies, processes and procedures to ensure that when a new infectious disease emerges, action is taken.
• Standard 5.29.2 has been expanded to require policies, processes, and procedures to observe recipients for complications related to immune effector cellular therapy.
• New standard 5.30.1 requires clinical facilities to provide data to their chosen registry in a manner that is consistent and appropriate.

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, 176 pages, and 2021, AABB, softcover, 128 pages)

Effective date: July 1, 2021

Nonmember price: $437

Member price: $300

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)