title: Introduction of a quality management system and outcome after hematopoietic stem-cell transplantation.
abstract: OBJECTIVE
  A comprehensive quality management system called JACIE (Joint Accreditation Committee International Society for Cellular Therapy and the European Group for Blood and Marrow Transplantation), was introduced to improve quality of care in hematopoietic stem-cell transplantation (HSCT). We therefore tested the hypothesis that the introduction of JACIE improved patient survival.
  
  
  METHODS
  Data on 41,623 allogeneic (39%) and 66,281 autologous (61%) HSCTs for an acquired hematologic disorder performed between 1999 and 2007 by 421 teams in Europe were used to assess the outcomes of patients who received a transplantation at baseline (> 3 years before application or no application), during preparation (3 years before application), during application (time from application to accreditation), and after JACIE accreditation. The analysis was clustered by team and stratified for year of HSCT, donor type, disease, conditioning, and gross national income per capita of the respective country. Patient's risks were adjusted for by their European Group for Blood and Marrow Transplantation score.
  
  
  RESULTS
  Patient outcome was systematically better when the transplantation center was at a more advanced phase of JACIE accreditation, independent of year of transplantation and other risk factors. Improvement was robust as quantified for relapse-free survival after allogeneic HSCT compared with baseline by a hazard ratio (HR) of 0.96 (95% CI, 0.90 to 1.03; P = .22) for preparation, 0.95 (95% CI, 0.88 to 1.03; P = .20) for application, and 0.86 (95% CI, 0.78 to 0.95; P = .01) for the accreditation (test for trend P = .01). Improvement from baseline was similar after autologous HSCT (HR for accreditation, 0.83; 95% CI, 0.74 to 0.93; P < .01).
  
  
  CONCLUSIONS
  Even with all the limitations of an observational study, these findings support the hypothesis that introduction of a comprehensive clinical quality management system is associated with improved outcome of patients after HSCT.
authors.affiliation: European Group for Blood and Marrow Transplantation Activity Survey Office, University Hospital, Basel, Switzerland. hematology@uhbs.ch
authors.forename: Alois
authors.initials: A
authors.lastname: Gratwohl
authors.forename: Ronald
authors.initials: R
authors.lastname: Brand
authors.forename: Dietger
authors.initials: D
authors.lastname: Niederwieser
authors.forename: Helen
authors.initials: H
authors.lastname: Baldomero
authors.forename: Christian
authors.initials: C
authors.lastname: Chabannon
authors.forename: Jan
authors.initials: J
authors.lastname: Cornelissen
authors.forename: Theo
authors.initials: T
authors.lastname: de Witte
authors.forename: Per
authors.initials: P
authors.lastname: Ljungman
authors.forename: Fiona
authors.initials: F
authors.lastname: McDonald
authors.forename: Eoin
authors.initials: E
authors.lastname: McGrath
authors.forename: Jakob
authors.initials: J
authors.lastname: Passweg
authors.forename: Christina
authors.initials: C
authors.lastname: Peters
authors.forename: Vanderson
authors.initials: V
authors.lastname: Rocha
authors.forename: Ineke
authors.initials: I
authors.lastname: Slaper-Cortenbach
authors.forename: Anna
authors.initials: A
authors.lastname: Sureda
authors.forename: Andre
authors.initials: A
authors.lastname: Tichelli
authors.forename: Jane
authors.initials: J
authors.lastname: Apperley
mesh_terms: D000068:Accreditation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D018380:Hematopoietic Stem Cell Transplantation / Q000592:standards*; D006801:Humans; D007223:Infant; D008875:Middle Aged; D010346:Patient Care Management; D011787:Quality of Health Care / Q000592:standards*; D016896:Treatment Outcome