Standards for Cellular Therapy Product Services, 5th edition

Effective Date: September 1, 2011The fifth edition of Standards for Cellular Therapy Product Services details the latest standards of practice for accredited cellular therapy facilities. Significant changes:New standard requires that informed consent documents be reviewed and approved by the medical director.New standard requires a plan for the eventual implementation of ISBT 128 labeling for cellular therapy products. Several revisions to infectious disease testing requirements including changes to requirements for autologous donor testing. Several standards requiring inspection and verification, particularly at the time of issue or distribution, have been revised to allow for the use of one individual and an electronic equivalent instead of requiring that two individuals verify labeling information.