Synopsis:
The eighth edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities. Significant changes to the 8th edition include: The 8th edition has expanded requirements for proficiency testing to ensure that the standards can be complied with outside of the United States where access to an external proficiency testing is limited. Standard 5.8, #6 requires all accredited laboratories to have implemented ISBT 128 labeling for all products by July 1, 2018, one year after the effective date of this edition. Standards for donor suitability and eligibility have been separated into two distinct sections in the standards (5.12.1 and 5.12.2 respectively) and their sections expanded. New standard 5.12.2.11 requires that all facilities have policies, processes and procedures in place to address all relevant emerging infectious diseases and that action is taken with regard to donor screening and testing processes.
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