The ninth 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.
(2019, AABB, softcover, 167 pages, ISBN 978-1-56395-993-6)
Effective date: July 1, 2019
Item Details
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