JACIE Office has recently received number of queries on the minimum activity required for facilities to achieve certification. Further, with the changes in clinical practice, meeting the minimum activity required can be challenging for bone marrow collection facilities in particular. Although this can be frustrating for the facilities affected, it is important to remember that these Standards are intended to protect the donors (autologous and allogeneic) and the product quality. The minimum activity requirements for each facility as per 9th Edition of the HCT Standards are summarised below.
Minimum Activity for Clinical Programmes
Minimum activity for Collection units (Standard C1.5)
Processing Facility
There is no minimum activity defined for the Processing Facility. However, as per explanation for Standard D1.3 the Standard requires that during a 12-month period, Processing Facilities need to process enough cellular therapy products to compile an adequate amount of data to validate processes and demonstrate compliance with the Standards. Facilities should have provided service for the minimal number of autologous and allogeneic transplants required for the associated Clinical Program to be eligible for FACT accreditation or JACIE certification.
Although the Standards do allow Facilities to apply for certification prior to the meeting the minimum volume, this is intended for exceptional circumstances only and the certification will not be awarded until the minimum volume is met. Therefore, it is for the Clinical Program or Collection/Processing Facility to decide, if it is in a position to accept the risk of not meeting the minimum volume (and not becoming certified) within the certification timeline.
JACIE office checks the activity of the applicant Centre/Facility at the application and will provide advise at that time on whether or not they meet the minimum activity. If you have any queries regarding the minimum activity requirements prior to applying for initial/re-certification, please do not hesitate to contact us on jacie@ebmt.org.