Use Of a Quality Management System and Outcome After Hematopoietic Stem Cell Transplantation

Competent authorities, healthcare payers and hospitals devote increasing resources for quality management systems (QMS) and accreditation/certification of parts or all of their activities. Scientific analyses searching for an impact on clinical outcome remain scarce. Hematopoietic Stem Cell Transplantation (HSCT) involves complex processes and requires the collaboration of multiple categories of health care professionals. Despite major improvements over time, it remains associated with significant mortality and might serve as a role model for any QMS. The Joint Accreditation Committee of the International Society of Cellular Therapy Europe (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT) – JACIE – has developed in collaboration with its US counterpart FACT standards that require a QMS. These principles apply to clinical management, cell collection and cell processing. Centers seeking accreditation are subject to a detailed document review, on-site inspection and auditing procedures. Earlier data indicated a stepwise improvement with each phase of the accreditation process (JCO 2011).

To test the hypothesis that working towards and achieving accreditation for the QMS “JACIE” would accelerate improvement in outcome over calendar time and, to quantify the potential impact on outcome.

A retrospective observational study of the previously published and well defined cohort of 107,904 patients treated with HSCT (41,623 allogeneic, 39%; 66,281 autologous, 61%) between 1999 and 2006, reported to the EBMT database and with substantially increased, complete follow-up information up to November 2012. A “JACIE⁺ “ center was defined as one which initiated the accreditation process and achieved accreditation at some point during the 14 year period, the latest by November 2012. Focus of the statistical approach was on the interaction between “JACIE⁺“ and calendar time on mortality reduction with adjustments for the key known risk factors. A completely different analysis framework has been chosen to test the hypothesis and to verify consistency between the two approaches.

Main outcomes and measures: The primary outcome measure was reduction in overall mortality at 72 months over calendar time for 49,459 patients having received their transplant in a “JACIE⁺ “ center; 58,445 patients whose center never obtained accreditation served as baseline (“JACIE^-”).

Overall mortality of the entire cohort decreased over the 14 years observation period by a factor of 0.67 per 10 years (HR: 0.67; 0.62-0.73). This improvement was significantly faster in “JACIE⁺ “ (approx. 5% per year; HR per 10 years: HR: 0.62) than in “JACIE^- “ (approx. 3% per year; HR per 10 years: HR: 0.73) centers. This difference in speed of mortality reduction was quantified by a HR of 0.85 (0.73-0.99) and resulted in a marked difference in outcome between the “JACIE⁺” and “JACIE^-” centers: adjusted non relapse mortality (HR 0.93; 0.83-1.04) and relapse incidence (HR 0.94; 0.88-0.99) were lower, while relapse free (HR 0.94; 0.88-0.99) and overall survival (HR 0.91; 0.85-0.97) were significantly higher at 72 months after allogeneic transplantation for those patients transplanted in the 162 “JACIE⁺ “ centers. No effects of “JACIE” accreditation were observed after autologous HSCT, not on speed of mortality reduction nor on overall survival (HR 1.06; 0.99-1.13).

Working towards and implementation of a QMS triggers a dynamic process which is associated with a steeper reduction in mortality over the years and a significantly improved survival after allogeneic HSCT. Our data support the use of a QMS for allogeneic HSCT as well as for other forms of complex medical procedures.

No relevant conflicts of interest to declare.