More than 145 European hematopoietic SCT programs have received JACIE (Joint Accreditation Committee for ISCT Europe and EBMT) accreditation since 2000, demonstrating compliance with FACT (Foundation for the Accreditation of Cell Therapy)-JACIE international standards. The association of JACIE with improved patient outcome was recently documented. However, conditions in which quality management systems were introduced and the actual benefits remain to be fully evaluated. Our study focuses on one aspect of quality management: introduction and use of indicators. Through a questionnaire sent to JACIE-accredited centers and responses from 32 programs (or 40%), we identified 293 indicators, including 224 (76%) that were introduced during the preparatory phase of JACIE accreditation. Indicators were associated with the following processes: measurement, analysis and improvement (54/293 or 18%); donor collection (49/293 or 16%); processing and storage of cell therapy products (37/293 or 12.5%); and administration of hematopoietic progenitor cells (67/293 or 23%). Mapping revealed an uneven distribution of indicators across the different subprocesses that contribute to this highly specialized medical procedure. Moreover, we found that only 101/293 indicators (34%) complied with the rules for implementation of a quality indicator, as defined by the FDX 50-171 standard. This suggests that risks to donors/recipients are unevenly monitored, leaving critical medical steps with low levels of monitoring.
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This work was supported in part by the JACIE executive office, by Institut Paoli-Calmettes and by Centre Hospitalier et Universitaire de Nancy. We thank Catherine Faucher and Noel Milpied at the Société Française de Greffe de Moelle (SFGM-TC) for their help in establishing the French survey. We also thank all members of the JACIE Executive Office and JACIE Accreditation Committee, all JACIE inspectors, and all health-care personnel at European hematopoietic SCT programs that care for patients. We also thank Nicolas Birouste at the Agence Française de la Normalisation (AFNOR) for helpful discussions. The list of JACIE-accredited programs that answered the survey appears in the legend to Supplementary Figure 1; we wish to express our appreciation to all respondents for their interest in the conduct and analysis of this survey.
The authors declare no conflict of interest.
Supplementary Information accompanies the paper on Bone Marrow Transplantation website
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Caunday, O., Agulles, O., McGrath, E. et al. Implementation of JACIE accreditation results in the establishment of new indicators that unevenly monitor processes contributing to the delivery of hematopoietic SCT. Bone Marrow Transplant 48, 604–609 (2013). https://doi.org/10.1038/bmt.2012.181
- hematopoietic SCT
- quality management
- risk management