BUNDLE: Standards for Cellular Therapy Services, 9th edition and Guidance for Cellular Therapy Services

Product Code: 193099

This combination provides the 9th edition of Standards for Cellular Therapy Services (CT Standards) and the Guidance for Standards for Cellular Therapy Services.

The 9th edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.

Significant changes to the 9th edition include:

A new standard requiring facilities have policies, processes and procedures in place to address operational continuity in situations where a facility’s operational status may be in question.
ISBT 128 labeling requirements for all products, recognizing different time frames at which point the label must be attached.
New clinical outcome requirements for facilities that administer or process islets.
New requirements for what must be included in records of products procured, processed or cryopreserved.
New standards focused on the monitoring of oxygen levels and the subsequent activation of alarms when they deviate.

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.

(2019, AABB, softcover, 167 pages, and 2019, AABB, softcover, 127 pages)

Effective date: Effective date: July 1, 2019