STANDARDS FOR CELLULAR THERAPY SERVICES, 10TH EDITION – PRINT

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