JACIE stopped all inspections in March 2020 due to the pandemic. By the Autumn of 2020 it was apparent that we would not be able to resume normal activity in the foreseeable future and so preparations for a remote inspection process commenced. While those preparations took longer than originally anticipated, the first pilot remote inspection took place in early June and July. Early signs show that the remote format can substitute in many aspects of the on-site inspection and gives us confidence that this will be an adequate alternative process until we can resume inspections onsite. This is particularly important as we expect that the restrictions will continue to be different across Europe for some time yet.
Nonetheless, the backlog has not stopped growing and at the time of writing, there are now 142 processes awaiting inspection (54 initial and 88 reaccreditation). While many of these processes are still accredited from their previous application, many centres are in an accreditation 'limbo' with internal and external repercussions possibly even affecting continuity of services. This is equivalent to a little under 2 years of applications in normal circumstances. It is clear that we cannot simply inspect our way through the backlog without taking an inordinate amount of time.
JACIE has an obligation to provide a service to centres, while ensuring that critical processes, particularly those affecting patient safety, continue to be controlled by the centres if the accreditation is to retain its value. Therefore, we are preparing a focussed process based on a reduced set of standards leading to an eventual 2 year accreditation period.
Centres eligible for a focussed process will be stratified by risk based on the criteria below:
- Activity - autologous, allogeneic, Immune Effector Cells
- Number of accreditation cycles
- Time since the last inspection
Centres scoring lower will be considered to be low risk while higher scoring centres will be classified as medium or high risk. Low risk centres will be subject to a document-based assessment only in the first instance while medium- and high-risk centres will require further inspection. The inspectors' assessments will be documented in an inspection report and presented to the JACIE Accreditation Committee. If any issues are identified, the centre will be required to respond with corrective actions before the accreditation can be awarded. Note that the outcome of the inspection process at any level could require further assessment of the centre where issues of sufficient concern are identified.
JACIE will subsequently approach the eligible centres during 2022 and 2023 to schedule full inspections (remotely or on-site) to avoid or minimise gaps between accreditation periods. By proactively approaching the centres in this way, we also hope to avoid future backlogs.
The above represents one of the most significant challenges in the history of JACIE and so we are especially asking for all Inspectors to get involved in the different inspection processes whether a desktop/documentation-based audit or remote and onsite inspections. We are also acutely aware that there’s been a long gap for most inspectors since the last inspection process but hope that the different processes – focussed documentation and remote inspections – allow everyone to revive their inspector skills and to stay in contact with all things JACIE. There will be opportunities for everyone to be involved due to the size of a challenge ahead.
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