22.9: Haemopoietic progenitor cell processing standards
22.9.1: Personnel and facilities
Processing facilities must comply with the requirements of the EU Directives on Tissues and Cells, FACT-JACIE Standards and NetCord-FACT Standards. There shall be a medical director/advisor who will 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.
There will be a laboratory director/manager who is responsible for the operational management and technical aspects of the service. There should be adequate numbers of staff whose training and competency to perform the assigned procedures must comply with the requirements of appropriate regulations and standards.
There must be a Designated Individual as defined by the EU Directives on Tissues and Cells/Human Tissue Act.
The HPC-processing 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. There must be a documented quality management system applied to all activities, and a designated quality manager.
- Before processing there should be a written request from the transplant physician. This is not required for unrelated cord blood collections.
- Processing should be performed according to written procedures and policies. All procedures must be validated prior to implementation. Aseptic techniques must be employed. Any deviation from such written procedures shall be documented and reviewed.
- Documented process simulation must be routinely undertaken to demonstrate that all processes are adequate and staff and facilities are fit for purpose.
- Before material is accepted from a third party, including receipt from abroad, the laboratory accepting the donation should, wherever possible, ensure that standards equivalent to those in UK guidelines have been met. Material should be inspected upon receipt and the condition of the product recorded.
- Where appropriate the HPC donation should be passed through a sterile non-reactive aggregate filter to remove fat, clots or bone spicules that may be present. A closed system must be used wherever practical.
- Processing and transplant facilities must agree and validate the adequacy of dose (total nucleated cells, mononuclear cells, CD34 positive cells and/or CFU-GM (colony-forming unit – granulocyte/macrophage) as appropriate for each source of HPC) required to achieve reliable and sustainable engraftment. Tests for cell dose and viability should be performed as in section 22.11.