This is the policy I developed for HMC Doha Blood Donor Center:
Policy:
- This policy applies to all blood donor processing (including reagents, materials, equipment) in the Blood Donor Center.
- Immunohematology testing and donor infectious disease marker testing are not included.
- Equipment and reagents must be selected to meet/exceed productions standards set by the Council of Europe, International AABB, HMC policies and procedures, and Qatari law.
- Each equipment must have a fully functioning, reliable, bidirectional interface to Medinfo Hematos IIG and be fully interfaced
- Vendor is responsible to pay for the interface licensing for each piece of equipment.
- Materials/reagents/equipment must cover the following functionalities:
- Automated separation of whole blood and apheresis components into:
- Packed RBCs in additive solution
- Buffy coat derived platelet pools
- Apheresis-derived platelets, plasma, and/or RBCs
- Fresh frozen and FP24 plasma
- Pathogen inactivation of whole blood, platelets, plasma, RBCs
- Cryoprecipitate
- Cryo-poor plasma
- Frozen RBCs (high-glycerol method)
- Washed RBCs
- Thawed plasma
- Irradiated RBCs
- Reconstituted whole blood (PRBCs and thawed plasma)
- Leukodepletion of ALL components to current and future CE standards
- Automated separation of whole blood and apheresis components into:
- Equipment must have/meet:
- CE mark or equivalent (FDA, CSA, etc.)
- Sufficient throughput for the workload in the area assigned
- Scalability: A path of upgrading to larger capacity/throughput equipment using the same reagent line of the vendor
- A minimum of two of each equipment type must be obtained to minimize disruption of blood supply.
- Vendors:
- Vendors must offer 24/7 service on critical equipment for donor blood component and patient compatibility testing
- Vendors who do not meet qualification standards must not be used.
References:
- Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
- Guide to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), European Directorate for the Quality of Medicines and Healthcare, Current Edition, Strasbourg, France