JACIE REPORT AUGUST 2022
JACIE Accreditation Office
EBMT, European Society for Blood and Marrow Transplantation
JACIE response to Centres about on-site inspections
In 2021, JACIE conducted pilot remote inspections to assess the feasibility of incorporating them into the accreditation process with the objective of offering remote inspections when the situation requires it.
Based on the results, the JACIE Committee has approved the remote inspection format to be used alongside the on-site format, so it is now available to reaccredited centers that meet the selection criteria (Ex: no facilitators are required, able to meet the IT requirements, etc.).
The format of the pilot remote inspections mimics as much as possible the on-site accreditation process. The main differences take place during the pre-inspection and inspection phases and include:
Inspection tasks are conducted through video conferences (opening/closing meetings, interviews and review of documentation).
The tour of the facilities consists of a video recording of the facilities (pre-recorded and/or alive).
The MED A forms
are excluded from the scope of accreditation.
The post-inspection phase of the accreditation process does not include major changes. The eventual accreditation certificate will indicate that the centre achieved accreditation via a remote process.
The development of different inspection processes has allowed JACIE to adapt to the specific situation of each centre with respect to COVID-19 with greater flexibility. Although on-site inspections remain the mainstay of the inspections, remote/virtual inspections allow for better contingency planning and improve resilience at times of uncertainty, whether due to a pandemic, travel or other restrictions.
Remote inspections have made it possible on various occasions to carry out inspections that would have had to be cancelled due to the high risk of contagion. The results obtained in recent inspections have shown that the restructuring from an on-site inspection to a remote one is perfectly plausible despite having a very limited time due to rapid rebounds in the rate of infections. In a recent case, due to the perimeter closure of a country, it was necessary to change an inspection to remote mode with only two weeks' notice.
Remote inspections consist of 2-3 half-day videoconferences where inspectors have the opportunity to meet and interview (1:1) the applicant centre team, as well as discuss any findings among themselves. From the JACIE office, several rooms are prepared:
One for each inspection area, for interviews.
One for the inspection team to discuss certain common issues.
Another general room with the complete IT equipment of the applicant centre for the opening and closing meetings.
To facilitate the evaluation by the inspectors, applicants are requested to provide a video tour of their facilities following specific instructions from JACIE. The purpose of a recorded video tour for a JACIE inspection is to demonstrate compliance with many Standards, particularly those related to the adequacy of facility design and size, security, cleanliness, environmental conditions and monitoring, safety measures, access to support areas, supply and reagent storage, and workflow which would not be possible to demonstrate otherwise but with visual confirmation.
Recently, since some inspectors have faced last-minute difficulties to travel for an on-site inspection which complicates going remote, JACIE has also implemented a hybrid inspection model. This hybrid model consists of having part of the inspection team on-site, while the inspectors with travel restrictions simultaneously conduct a remote inspection. This solution allows us to maintain the inspection dates as originally scheduled, thanks to the collaboration of the applicants and the inspectors. The applicants need to set up meeting rooms to allow both on-site and remote inspectors to participate jointly and to provide streaming for the tour of the facilities, while the inspectors need to work as a team despite the distance.