Reminder: Feedback on Proposed CT Standards Due Oct. 8

The proposed draft Standards for Cellular Therapy Services (CT Standards), 12th edition, is available for public comment through Oct. 8. 

A summary memo that accompanies the proposed CT Standards provides a comprehensive description of the additions and edits in the draft. Some of the significant changes include: 

• Each chapter now concludes with the record retention table for those standards. AABB notes that a comprehensive record retention table still exists in Chapter 6. 

• Proposed Standard 1.7.1 has been added requiring that accredited cellular therapy facilities notify AABB in the case of nonconformances that could cause serious injury, harm, or death. 

• Proposed Standards 5.1.9.1 and 5.1.9.1.1 have been added to require that suppliers and/or consignees of cellular therapy products provide evidence of processes for traceability, tracking and recall. 

• Proposed Standards 5.1.10.1, 5.1.0.2 and 5.1.10.3 have been added to address requirements set forth by the Centers for Medicare and Medicaid Services concerning proficiency testing referrals and what is and is not currently allowed until the results of proficiency testing are complete and submitted.

• Proposed Standard 5.18.2 has been added to ensure that facilities have stability programs for all expiring products. 

• Proposed Standard 5.22.4 has been added to ensure that facilities that are reissuing returned products to inventory have defined conditions for reintroduction to inventory. 

• Proposed Standards 7.3.6 – 7.3.6.1.2 have been added to ensure that facilities address the reporting and prompt investigation of communicable diseases. 

In addition, the proposed 12th edition of CT Standards incorporates the updated quality systems essentials that form the basis for all sets of AABB standards. The updated quality systems essentials provide a one-page guidance before the beginning of each of the 10 chapters. This guidance includes: 

• A description of the chapter and what the standards therein cover. 

• A list of key terms that mirror the content of the chapter and that should be kept in mind when reviewing the standards. 

• A list of key objectives that an assessor could look for during an onsite assessment; however, this list is not comprehensive. 

Users should note that these are not requirements that members will be held against. Rather, they are tools to assist users in their understanding of the content of the chapter. 

The Cellular Therapies Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the 12th edition are in the proposed phase and will be finalized after the comment period has concluded. The committee will review all comments submitted and provide a summary document that describes the committee’s rationale for its final decisions.