With the global increase in the use of cellular therapies, there has been an increasing need for compliance with quality standards. The most important guidelines in this respect are the European Union Directives and FACT-JACIE standards.1-3
In Turkey, harmonization with international standards began in bone marrow transplant centers in 2004. The first center, which received JACIE accreditation in 2012, received reaccreditation in 2016; currently, it is in the process of applying for a third accreditation. Below, we have compared the quality management activities required for compliance with the standards (in terms of quality management parameters, such as documents, personnel, communication, and transfers) for the first, second, and third international accreditations. Training activities, adverse events, inspections, and number of transplants performed were compared numerically among the applications. The approach of the staff and management to the application process was assessed observationally.
Our analysis showed that required preparation time shortened with successive applications (Table 1). Training activities were well maintained and increased during key periods, whereas the number of access-controlled documents decreased. Staff compliance increased continually. Uncertainty decreased with regard to shared responsibilities, not only within the team but also with respect to other departments and consultants. All types of support provided by hospital management staff increased. Moreover, as a result of the standard approach that we developed, transplant activity increased significantly.
During the first application process, personnel were resistant to the idea of accreditation (especially physicians, nurses, and hospital management staff); however, by the time of the third accreditation period, key clinical personnel involved in data collection and processing had adapted to, and further improved, the process. The 650 weekly communication meetings held to date support this finding. One of the most important factors in this improvement is thought to be the absence of turnover among key staff.
A consultant appointed during the first accreditation process noted uncertainty among team members with respect to their duties and responsibilities. However, these uncertainties were completely resolved by the time of the third application process. Based on the 18 meetings held with hospital managers over the past decade, management is fully supportive of the continuation of the accreditation process.
New versions of JACIE had been implemented at the time of all 3 applications. However, the compliance of staff with the new standards increased significantly with successive applications; commensurate with this, the time taken for the application process gradually decreased. Meetings held during the earlier applications focused on defining the requirements that needed to be met, whereas meetings held during the third application focused on how to actually meet the requirements, since the standards were clearly understood by then.
For the first application, a large number of documents were created based on the premise that “quality means documentation.” The number of documents created decreased during the second and third application processes, and a new format has been implemented that will reduce the workload and paperwork associated with the final application process. In addition, electronic versions of many documents have been prepared.
Training courses, including online training, were not documented among the training data. During the second accreditation process, since more training was needed to adapt to the sixth version of JACIE, an increase was observed in the number of training activities. However, the overall continuity of the training was preserved.
A substantial increase in the number of transplants carried out was observed across the accreditation applications, reflecting increases in experience and quality management. In line with this, improvements in patient experience were also observed.
At present, the lessons learned over the past 10 years of accreditation applications are being implemented by hospital personnel on a daily basis, and compliance with the JACIE standards is continually improving.
We believe that our analyses can facilitate harmonization with international accreditation standards, which will in turn help standardize patient care services among transplant centers all over the world. In conclusion, this summary can help to guide other centers that are aiming to become accredited.
DOI : 10.6002/ect.2020.0103
From the 1Baskent University Adana Adult Bone Marrow Transplant Center and
the 2JACIE Quality Manager Group, Adana, Turkey
Acknowledgements: The authors have no potential conflicts of interest of interest to disclose and received no funding for this study.
Corresponding author: Ilknur Kozanoglu, National Representatives of JACIE, Baskent University Adana Adult Bone Marrow Transplantation , Centre, Adana, Turkey
Table 1. Comparison of Quality Parameters Among JACIE Accreditation Applications