HPC-A, HPC-M, HPC-C and TC should only be collected in a hospital facility or Blood Service apheresis unit with appropriate experience (see section 5.8) and which meets the standards required by the EU Directives on Tissues and Cells, FACT-JACIE Standards and NetCord-FACT Standards as appropriate. The facility will be headed by a medical director/advisor and a collection facility director with appropriate experience as described in the above standards. The collection facility shall have an organisational structure and operational procedures appropriate for the activities carried out. There must be an organisational chart which clearly defines accountability and reporting relationships. The medical director/advisor shall have responsibility and authority for all clinical aspects of the programme including compliance with national and local guidelines as well as ensuring compliance with regulatory requirements.
The collection facility director is responsible for the operational management and technical aspects of the service. The medical director/advisor may also act as the collection facility director. There shall be adequate numbers of staff whose training and competency to perform the assigned procedures must comply with the requirements of the EU Directives on Tissues and Cells, FACT-JACIE Standards and NetCord-FACT Standards.
There must be a documented quality management system applied to all activities, and a designated quality manager.
There must be a Designated Individual as defined by the EU Directives on Tissues and Cells/Human Tissue Act.
HPC-M donors should be assessed and managed in accordance with the aforementioned guidance. Specific points of importance are:
HPC-A donors should be assessed and managed in accordance with the aforementioned guidance. Specific points of importance are:
HPC-C collections should be managed in accordance with the aforementioned guidance. Specific points of importance are: