Identification, categorization, and mapping of indicators used by JACIE-accredited stem cell transplantation programs to assess distribution and coverage of processes.

Abstract

255 Background: More than 145 European hematopoietic stem cell transplantation (HSCT) programs received JACIE accreditation since 2000, demonstrating compliance with FACT-JACIE international standards. The association of JACIE with improved patient outcome was recently documented. Conditions in which quality management systems were introduced and actual benefits remain to be fully evaluated. Methods: The study explores one aspect of quality management: introduction and use of indicators. Through a questionnaire sent to JACIE accredited centers, we aimed at identifying indicators (name, domain of application, category, longevity, and general description), understanding how they were set in place, whether or not similar indicators were used by different programs, and whether all of the HSCT processes were monitored. The survey was first sent to 14 French accredited HSCT centers and next to 68 other programs in 11 European countries. Categorization was double-checked against published criteria. Results: The response rate was 40% (32 programs). 293 indicators were collected, 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%), administration of HPC (67/293 or 23%). Mapping reveals an uneven distribution of indicators across the different sub-processes that contribute to this highly-specialized medical procedure. Moreover, we found that only 101/293 indicators (34%) comply with the rules for implementation of a quality indicator, as defined by the FDX 50-171 standard. Conclusions: This suggests that risks to donors/recipients are unevenly monitored, leaving critical medical steps with low levels of monitoring.