An Overview of Quality, Standards and Accreditation in Bone Marrow Transplantation

Background and Aim: The HSCT sector has been a pioneer in the areaof healthcare quality, standards and accreditation. From the mid-1990sonwards, several organizations in the United States and Europe developedinitiatives to improve quality and safety of this complex therapeuticintervention based on standards and voluntary accreditation processes.AABB, FACT and JACIE have set the benchmark and internationally areregarded as the reference organizations.Methods: Standards are developed by professionals working day-todayin HSCT. They are evidence-based as much as possible and wherethis is not feasible, the consensus is reached on the most appropriateapproach. More generic standards focus on installations, staff educationand skills, quality management, patient and donor management and carewhile more technical requirements cover specific aspects of the processe.g. stem cell storage, transportation, administration of the product.Accreditation is a tool or mechanism that nowadays is widely acceptedin healthcare as a means to drive quality improvement and adherenceto standards. Accreditation is usually based on an application processrequiring presentation of documentation followed by an on-site visit byauditors or assessors, usually drawn from the professional community(peer-review), who verify compliance with the Standards. The assessorsissue a report which is normally reviewed by a dedicated expert group orcommittee. The committee issues a recommendation on any actions thatthe center should implement in order to achieve accreditation. JACIE isbased in the EBMT offices in Barcelona, Spain from where applicationsand inspections are managed. Training is also provided both in-personand currently small-scale online content.Results: Key factors in the success of accreditation in HSCT have beenthat (i) it is driven by the professional community, (ii) there is evidence ofa positive impact on patients and donors, (iii) it complements regulatoryrequirements, and (iv) it is positively viewed by regulatory agencies. Since2000, JACIE has received 418 applications from transplant programmesor facilities in 33 countries in Europe, Asia, South America and Africa.Over 350 have been inspected and more than 326 accreditation awardshave been issued. JACIE accreditation is also recognized by regulatorsin 7 European countries and features in numerous guidelines. JACIEinspectors now number 289. Threats to the sustained success of thismodel are persistent perceptions of an over-bureaucratic process thatgenerates substantial paperwork, ever-expanding requirements andthe not insignificant costs required to maintain compliance duringaccreditation cycles. One initiative to address this issue is the Stepwiseproject which aims to make the accreditation process more accessiblefor centers in low- to medium-income countries by breaking therequirements into graded steps.Conclusion: The HSCT community is to be congratulated for its proactivefocus on quality and safety which in fact pre-dates many subsequentinitiatives in areas of medicine. In order to avoid complacency, thecommunity must continue efforts to follow and reflect developments inpractice so that the model remains relevant and a driver of excellence.

Keywords:

Quality , Accreditation , Standard , Transplantation