The pandemic has made it to be impossible to maintain the regular JACIE accreditation services while the situation in Europe and elsewhere remains unpredictable. Onsite visits place our volunteer inspectors at risk and by extension their patients, families, and colleagues. Furthermore, we have seen travel quarantine requirements change with little advance notice which threatens the inspectors’ ability to return to their workplace. Finally, we are finding that travel and hotel services are also amending or cancelling reservations which seriously undermines our arrangements.
Therefore, in the interest of the safety of our volunteers and centres, EBMT has decided to move all inspections to a remote or virtual format. By offering an alternative format, JACIE wants to keep centres on track towards accreditation during this emergency. This decision was endorsed by the EBMT Executive Committee members on 15th September and was approved at the EBMT Board meeting in mid-October 2020.
JACIE is near to completing the process for conducting remote assessments. This change presents challenges but it will help minimize the risk of further delays in the accreditation process while protecting the safety and health of inspectors and centres. The main actions taken include:
- Eligible centres - given the limitations of the remote format, only reaccreditation inspections will be performed remotely. First-time inspections will be scheduled for on-site visits as soon as circumstances permit.
- Establish the scope of the inspection – a thorough assessment of the inspection checklist by the JACIE Inspectors Committee concluded that to fully replicate the scope of an on-site inspection would make very high demands on inspectors' time with a very high number of documents needed to be provided by the applicant and reviewed by the inspector. Consequently, a more limited process based on a broad selection of items considered most relevant to patient, donor and product safefy was considered to be a feasible and pragmatic approach to an exceptional situation.
- Format - the process will be largely based on a document review by the inspectors and then a series of online interactions via video-conferencing according to a pre-defined schedule.
- Outcome for applicant centres - any eventual accreditation will be for a limited period of 2 years maximum. The certificates will state that the accreditation was based on a remote inspection.
- Communications – we will be contacting those centres who were already scheduled for an on-site inspection
- Technology – Microsoft Teams is being set up a platform to support the process. User licences will be prepared by JACIE for inspectors and centres. Centres will be assessed to establish that they can used this technology e.g. file-sharing, video-conferencing
- Documents - a list of documents to be provided by the centre in advance has been prepared. There may be some additional documents not already requested from the applicants
- Guideline(s) to explain the remote assessment process step-by-step
- Training – webinars will prepare users in the new format and tools
The first pilot centres will be early 2021 and are likely to be the smaller, single-site processes in view of their relative simplicity. From there we will start to approach the other centres to request their participation along with the inspection teams. Centres will be asked to agree to this format before proceeding.
We are fortunate to be able to count on the expert feedback from the newly-formed Inspectors Committee who will asked to validate the proposed process and to provide other input. Furthermore, centres are already experiencing remote assessments by their competent authorities or other organisations so there is growing familiarity with the concept.
At this early point, we expect that a remote assessment will likely make some more demands on the centres and the inspectors in advance of the inspection in terms of providing and reviewing documentation. We do anticipate more coordination via videoconferencing which in turn could help to make the inspection more interactive. As we gain more experience, we will review the process to see where improvements could be made with a view to evaluating the longer-term impact on the process including outside of the pandemic context.
For any questions, please write to jacie@ebmt.org