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Interim Cellular Therapy Standards Published

posted 31 Oct 2012, 02:11 by Eoin McGrath   [ updated 9 Jul 2015, 01:14 ]
FACT and JACIE have published interim standards in the fifth edition FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration pertaining to the following topics:
  • Red cell antibody screening (B6.4.2)
  • Donor eligibility versus suitability (B3.4.3.3, D6.1.7, and D6.1.8)
  • General clarification (B4.10.5)
These interim standards were incorporated into the 5th edition in response to feedback received from transplant programs and related organizations. Changes to a current edition of Standards are reserved for only those that are urgent in nature or frequently requested with compelling reasons. Because the changes relaxed a requirement, clarified regulatory requirements, or reinforced the original intent, no public comment period was opened. The interim standards will be effective after 30 days, or November 30, 2012.

The changes made are summarized in Appendix IV of the updated Standards.

Updated Guidance Information Published in Cellular Therapy Manual
FACT, in partnership with JACIE, has updated the Cellular Therapy Accreditation Manual to proactively share precedent-setting decisions with inspectors and programs so that everyone is able to accurately apply the Standards in the same manner as the Accreditation Committees. This information helps the intent of the Standards to be consistently applied by all programs and subsequently assessed by inspectors.

The Cellular Therapy Manual has been updated to explain the different areas of ASHI/EFI accreditation (Cellular Therapy Standard B2.4.6). In addition, the Cellular Therapy Accreditation Manual has additional information regarding the following:
  • Access to Marrow Collection Facilities and physicians trained and competent in marrow collection (B3.3.4)
  • HLA typing (B6.4.10)
  • Safe administration of preparative regimens (B7.4)
  • Representative samples (D6.1.2.2)
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