Standards Development Updates
By Monique Summers, RN, MSN, MPA
FACT Standards Development Manager
Standards Committee members have risen to the challenges of COVID-19 over the past two years, and all four sets of FACT Standards have been in the active phase of the review process. Members have incorporated feedback from constituents, discussed new developments in cellular therapy, and edited drafts. Updates for each set of Standards are provided below. As progress continues, important updates will be announced.
FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition
FACT and JACIE finalized the eighth edition Hematopoietic Cellular Therapy Standards in August 2021 with a revision in December 2021. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, cord blood, or other tissues and administered by a blood and marrow transplant (BMT) team.
The FACT Accreditation Services department is working with accredited and applicant programs that are beginning the accreditation process under the eighth edition and is available for questions.
FACT Standards for Immune Effector Cells, Draft Second Edition
The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy. To ensure that the Standards reflect emerging changes in the field, FACT delayed the publication of the second edition to incorporate the expertise of providers with Tumor Infiltrating Lymphocyte (TIL) experience. The committee has resumed its work and plans to publish the draft for a second public comment period in late 2022.
FACT Common Standards for Cellular Therapies, Draft Third Edition
The draft third edition FACT Common Standards for Cellular Therapies was published in 2021 for public comment. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy. This includes HPC transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. The third edition is scheduled to be published soon.
NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Draft Eighth Edition
The Steering Committee kicked off the drafting of the eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration in May 2021, and subcommittees have been meeting for the past year. The Steering Committee will meet during the 2022 Cord Blood Connect meeting in Miami, Florida to complete a final review of the draft prior to public comment, which is scheduled for late 2022.
