A quality management system is a mechanism to ensure that procedures are being carried out in line with agreed standards with full participation by all staff members. In a cell transplant programme, this ensures that the clinical, collection and laboratory units are all working together to archive excellent communication, effective common work practices and increased guarantees for patients. It is a means of rapidly identifying errors or accidents and resolving them so that the possibility of repetition of the problem is minimised. It assists in training and clearly identifies the roles and the responsibilities of all the staff.
Once the required level of quality has been achieved, the remaining challenge is to maintain this standard of practice. With a working quality management system in place and adequate resources, the fundamental elements necessary to sustain the programme are continued staff commitment and vigilance.
Evidence has emerged of a relationship between quality in transplantation and improved patient outcome. Findings were first published in 2011 in JCO and indicated that improvement of overall survival peaks at 14% for patients with chronic leukemias who received an allogenic HSCT. A follow-up study recently published (February 2014) in Haematologica has confirmed the quality effect on accelerating improvement over time.
In support of these findings and to reinforce the importance of quality management, JACIE introduced inspectors specifically to focus on the quality management standards in mid-2016, alongside the existing inspector profiles. These inspectors are responsible for assessing compliance with the standards for quality management and policies and procedures across all services in transplant programmes.
Studies on the impact of accreditation
Gratwohl, A. et al. Use of the quality management system “JACIE” and outcome after hematopoietic stem cell transplantation. Haematologica haematol.2013.096461 (2014). doi:10.3324/haematol.2013.096461
Gratwohl, A. et al. Introduction of a Quality Management System and Outcome After Hematopoietic Stem-Cell Transplantation. J. Clin. Oncol. 29, JCO.2010.30.4121– (2011)
Piccirillo, N. et al. Twenty years of unrestricted hematopoietic stem cell collection and storage: impact of Joint Accreditation Committee International Society for Cellular Therapy Europe standards implementation on stem cell storage policy and resource utilization. Cytotherapy 15, 519–21 (2013).
Caunday, O. 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, 604–9 (2013).