Where does all the blood go?
In 2022/23 Lifeblood collected over 1.6 million individual donations of whole blood, platelets, or plasma.
But have you ever wondered if we can follow the journey taken by each of these donations over their lifespan? What about 20 or 30 years after donation? Does it matter?
Clearly it does matter. Full and enduring traceability of blood and blood products is essential, for example, if we needed to identify donors or recipients if a historical transfusion or newly discovered pathogen prompted a retrospective investigation or lookback.
What do we mean by ‘traceability’? Blood and blood products are medical products of human origin (MPHO) and recent International Society of Blood Transfusion (ISBT) Guidelines for traceability of medical products of human origin offers the following definition: “… the maintenance of a permanent continuous information trail beginning with the selection of donors of MPHO and continuing through procurement, processing, testing, distribution and recipient matching to the final disposition of all the sub-products, ensuring timely tracing from donor to recipient and vice versa is possible ...”.[1]
This definition emphasises the wide-ranging and complex multistep process that underpins modern blood transfusion. Maintaining records for all the many moving parts requires a robust system that meets legislated state/territory and national requirements. While the regulatory requirements for a manufacturer such as Lifeblood under the Therapeutic Goods Administration (TGA) Australian code for good manufacturing practice (GMP) will differ in some respects to those imposed on a hospital or pathology provider by, for example, the Australian Commission on Safety and Quality in Health Care (ACSQHC) Blood management standard or Requirements for transfusion laboratory practice, the essential requirements for record-keeping enabling traceability are the same.[2, 3, 4]
Traditionally, record-keeping would be paper-based. Over time, files will likely have ended up in a dark and dusty archive probably never to be accessed again or eventually destroyed, whether deliberately culled or following some environmental calamity such as a fire or flood. Now in the digital age, electronic records have undoubtedly streamlined the record-keeping process. Reducing the physical storage space required, and undoubtedly making searches for historical information easier, paperless systems generate vast quantities of data now stored out of sight in the ‘cloud’.
The transition from paper to microfiche to electronic records, moving physical storage locations, changes to or closure of organisations or avoidable loss of records will all potentially impact traceability. But whatever the medium for collecting and storing information, be it physical, electronic or a combination, it’s essential that a continuous and retrievable record exists for the mandated retention period. Even in the digital era as storage methods evolve, there’s no guarantee that legacy systems remain compatible with new technology or there may be well-meaning organisational decisions to limit historical information migrated between systems or from one medium to another. Obviously, any migration of records between systems needs to ensure no loss or corruption of data.
In 30 years from now can we guarantee any information generated today remains accessible to whoever needs it? We can only imagine what technological advances or requirements will need to be accommodated or what decisions will affect ongoing traceability.
Ensuring records remain accessible over long periods requires well-designed systems responsive to inevitable changes over time. The ISBT guidelines provide a comprehensive overview of traceability. Their recommendations will allow organisations to assess their record-keeping practices, identify opportunities for improvement, and provide a strong platform to build from.
References
- Ashford P, Butch S, Barhoush AO, Bolton W, Cusmai M, Espensen L, et al. International Society for Blood Transfusion Guidelines for Traceability of Medical Products of Human Origin. Vox Sang. 2023; 118:587–97. https://doi.org/10.1111/vox.13473
- Therapeutic Goods Administration (TGA). Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products. Version 1.0 May 2013 (cGMP) (Available at: https://www.tga.gov.au/resources/resource/guidance/australian-code-good-manufacturing-practice-human-blood-and-blood-components-human-tissues-and-human-cellular-therapy-products)
- Australian Commission on Safety and Quality in Health Care (ACSQHC). Blood Management Standard. In: National Safety And Quality Health Service Standards. Sydney: ACSQHC, May 2021. (Available at: https://www.safetyandquality.gov.au/standards/nsqhs-standards).
- Australian Commission on Safety and Quality in Health Care. Requirements for transfusion laboratory practice. 5th ed. Sydney: ACSQHC; 2022 (Available at: https://www.safetyandquality.gov.au/publications-and-resources/resource-library/requirements-transfusion-laboratory-practice-fifth-edition).
