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Special Request for Public Comments: Evaluating One-Year Survival in FACT-JACIE Standards

posted 10 Nov 2014, 03:07 by Eoin McGrath   [ updated 9 Jul 2015, 00:55 ]
Survey concluded

FACT and JACIE are finalizing the sixth edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Based on public comments and strategic initiatives, an additional standard is proposed:

“The Clinical Program should achieve one-year survival outcome within or above the expected range when compared to national or international outcome data. If expected one-year survival outcome is not met, the Clinical Program shall submit a corrective action plan.”

The FACT-JACIE Standards already require internal outcome analyses. With the introduction of published comparative national and international data, Clinical Programs have additional resources to evaluate their one-year survival rates and improve upon them when they fall below expected ranges. Note that this standard is written with “should,” signifying that it is a recommendation. If a Clinical Program does not meet expected outcomes, accreditation will not be withheld but the program will be required to submit a corrective action plan for achieving expected one-year survival.

The proposed Standard, general principles and limitations, proposed implementation process, and instructions for submitting comments are described in the official Request for Public Review and Comment: One-Year Survival for Allogeneic Transplant Requirements. We strongly encourage review of this document to gain a full understanding.

Access the online comment form at www.surveymonkey.com/s/clinicaloutcomes.