Initial Considerations and Questions for Routine Leukocyte Reduction in Component Processing

Physical, Technical and Staffing Capabilities

Key Implementation questions to be considered:

• Considerations in choices of in-line and dockable systems.
• Is there an adequate component processing area?
• Is there adequate refrigeration space (walk-ins for cold refrigeration of RBCs)?
• What are the existing staffing patterns and the FTE’s that may be required?
• Can non-lab staff be trained on filtration, such as use of whole blood filtration in donor facilities or at mobiles?

Information Systems

Key documentation and validation questions to be considered:

• With converting the inventory to leukocyte reduced components, is there capability to document different anticoagulants/additive solutions and collection bag configurations (manufacturer, lot numbers and expiration dates, etc.)?
• Will any of these changes require retraining and validation or other changes?
• If the blood center has a new prestorage leukocyte reduced customer, is the hospital customer’s computer system ready to handle "prestorage leukocyte reduction?"
• Are there other documentation issues?

Regulatory Affairs

Key registration and licensing questions to be considered:

• With prestorage leukocyte reduced red cells and platelets, will addendums to registration and licensure applications be required?

Inventory Management

Key product mix questions to be considered:

• Donor projections and collection issues will require consideration of how to meet the needs of hospital customers. In times when daily blood collections have not yielded the projected “mix” of components required, will the use of dockable filters or dispensing bedside filters be an alternative or back up? Close communications with hospital customers will be very important to inventory management. The needs for inventory management although moving towards universal leukocyte reduction will likely be very challenging.