Documentation and traceability
Traceability
Traceability is essential for safe transfusion practice. It must be possible to trace every blood component and product throughout the system:
- from the time of donation to dispatch by Lifeblood
- to receipt by the transfusion laboratory, and
- to its ultimate fate, whether this is to a patient, clinical area, another facility or disposal.
The need for traceability extends to the post-transfusion period as well.
At any stage in the journey of blood - from donation, manufacture, testing, quality and temperature control, transport and storage - a blood component may be found unsuitable (or potentially unsuitable) for transfusion and need to be quarantined, recalled or discarded. When blood components that carry a significantly increased risk of harm to a recipient have already been transfused, Lifeblood has duty of care to notify transfusing clinicians.
Robust systems to track the fate of components are required throughout the entire blood chain from collection to administration. This includes blood components after release from Lifeblood, being recorded in and out of transfusion laboratory inventories and remote blood fridges, and the documentation of transfusion or discard. In the event of an adverse event or recall, the component must be able to be traced.
Appropriate retention of records, data and documentation as required by regulatory bodies for the required duration is vital for traceability.
Documenting the fate of blood components and products
Every blood component and product must be traceable from receipt by the laboratory to its final fate, whether this is to a patient, clinical area, another facility, or disposal.
The change in status or fate of each blood component and/or product must be recorded by the laboratory, for example:
• ISSUED (i.e. from the laboratory or a remote location)
• TRANSFUSED (where this is known)
• DISCARDED (e.g. expired, out of controlled storage, damaged or recalled by supplier)
• TRANSFERRED to another laboratory or institution.
Laboratories must have written policies that ensure proper and efficient inventory management including traceability.
Documentation of donation or batch number must also occur with movement of blood components and products outside the laboratory – when they are moved into or out of temperature-controlled storage, the paper-based or electronic register designated for this purpose must be completed.
Healthcare record documentation of transfusion
Permanent documentation of the transfusion episode must be kept in the patient’s healthcare record, including the donation or batch number. All records must be held in accordance with the mandated retention periods.
Updated January 2026
