FACT-JACIE Standards specify that all collaborating units—Clinical, Collection, and Processing—must comply with Standards B1.2 and C1.2 in order to achieve certification:
- B1.2: The Clinical Program shall use cell collection and processing facilities that meet FACT-JACIE Standards with respect to their interactions with the Clinical Program.
- C1.2: The Apheresis Collection Facility shall use cell processing facilities that meet FACT-JACIE Standards with respect to their interactions with the Apheresis Collection Facility.
These standards ensure that every component of the cellular therapy process operates under certified, quality-assured conditions. However, at times as separate Facilities, the certifications of these different legal entities may fall out of alignment as the certification and the inspections are independently managed. This can happen when applications are submitted at different times or when delays arise in the review or inspection process. In order to support Facilities in these situations, a conditional certification may be granted under specific circumstances.
When does a Conditional Certification apply
While it remains the responsibility of each program to ensure collaboration only with certified facilities, JACIE may, in specific cases, consider granting conditional certification for up to one year—provided that all involved Facilities are actively seeking initial certification or a recertification. The Facility granted a conditional certification must be assessed as fully compliant with all other FACT -JACIE Standards.
This approach allows Clinical and/or Collection Units to maintain certification while their associated Collection and/or Processing Unit completes its certification process.
Key Details
- Conditional certification is valid for one year.
- It will be extended for the remainder of the certification cycle (up to four years total) once the collaborating Collection and/or Processing Unit achieves certification within that timeframe.
- If the external unit(s) do not achieve certification within one year, no further extension will be granted.
- In such cases, the centre should transition to working with a JACIE-certified Collection and/or Processing Unit within the one-year period to maintain certification.
Why This Matters
This policy reflects a core principle of the FACT-JACIE Standards:
All participating units must operate under certified conditions, recognising their essential and interdependent roles in ensuring the highest standards of patient care and safety.
Conditional certification provides a balanced, practical solution that supports continued compliance and patient safety while allowing flexibility for centres navigating certification timelines.
Need Support?
If you have questions or require additional support, please contact the JACIE Office at jacie@ebmt.org.