22.7: Collection facilities for HPC-A, HPC-M, HPC-C and TC

22.7.1: General

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.

22.7.1.1: HPC-M donors

HPC-M donors should be assessed and managed in accordance with the aforementioned guidance. Specific points of importance are:

• A consultant anaesthetist should take responsibility for the care of the donor during the harvest procedure.
   
• There should be intensive care (or equivalent) and resuscitation facilities on-site.

22.7.1.2: HPC-A donors

HPC-A donors should be assessed and managed in accordance with the aforementioned guidance. Specific points of importance are:

• Physicians prescribing human growth factors must be experienced in their use.
   
• Donors and recipients undergoing progenitor cell mobilisation must have access to advice and medical supervision 24 hours a day.

Venous access

• Peripheral veins should ordinarily be used for venous access for donors.
   
• Where access via peripheral veins is not feasible and appropriate consent is obtained, central venous catheterisation (e.g. via the femoral or other route) may be considered.
   
• The placing of central catheters should only be undertaken in hospital facilities with access to intensive care and radiology facilities by highly trained staff who regularly perform this procedure.
   
• Collection centres must ensure that the adequacy of central venous catheterisation has been confirmed.

22.7.1.3: HPC-C collections

HPC-C collections should be managed in accordance with the aforementioned guidance. Specific points of importance are:

• For unrelated collections there must be a written agreement defining the responsibilities and expectations between the cord blood bank and the obstetric department of the collection hospital.
   
• For directed allogeneic or autologous collections, harvested in a non-fixed collection facility, there must be a written agreement related to HPC-C collection, transport, processing, testing, storage and release, between the referring consultant and the HPC facility.
   
• Delivery practices must not be modified in an attempt to facilitate HPC-C collections.
   
• There must exist a documented system for identification of the HPC-C product and for confirming the link with the mother.