AABB Releases 10th Edition of Standards for Cellular Therapy Services

April 07, 2021

The 10th edition of Standards for Cellular Therapy Services (CT Standards) is now available for purchase in both electronic and printed formats. The 10th edition will take effect July 1 and includes a number of changes and additions. AABB’s Cellular Therapies Standards Committee wishes to highlight the following updates:

  • New Standards 1.5 and 1.5.1 require that facilities perform comprehensive reviews of their cell processing procedures to identify areas that may be at risk for introducing contamination or causing potential loss of cell function. 
  • A new standard (3.6.2) has been added to the edition requiring that facilities have processes in place to ensure that all facilities have measures in place to minimize the risk of an internal or external data breach.
  • New Standard requires that facilities identify vulnerable donor populations and determine which individuals require access to a donor advocate ahead of the donation process.
  • Standard has been edited to require that facilities have policies, processes and procedures to ensure that when a novel infectious disease emerges, action is taken.
  • New standard 5.30.1 requires that when facilities report outcomes data to a registry, it is done so in a consistent manner.

The 10th edition of CT Standards can be purchased in the AABB Store and can be purchased in a number of formats. A bundle of the print and digital versions of the CT Standards is now also available. Individuals who purchase the digital version of the 10th edition will gain access to the edition in the Standards Portal. The electronic version also contains live-linked Food and Drug Administration regulations and the ability to print the Standards on demand. Print versions of the CT Standards and CT Standards and Guidance bundle are also available for pre-order.

Individuals with questions regarding the 10th edition should contact the Standards Department at standards@aabb.org.