Standards for Cellular Therapy Services, 9th edition – print

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.