In Focus
Standardized electronic messaging to improve transfusion records and traceability
Striving for efficient traceability between recipients and donors
The need to maintain accurate records and ensure traceability from donor to recipient, and from recipient to donor has long been recognized as an essential requirement to reduce risk of transmission of infection by blood transfusion.
Regulations in many countries require blood establishments and hospital blood banks to retain information to support traceability (e.g. EU Regulation 2024/19381).
The information stored by these organizations, if complete, provides a mechanism to trace from the donor to the recipient. However, for traceability starting at the recipient it is necessary to identify the organizations holding the records before traceability back to the donor can be achieved. This becomes increasingly difficult as the time interval from transfusion event to lookback increases. The recent UK Infected Blood Inquiry (IBI) Report identified the administrative difficulties in maintaining such records and identified numerous failings in traceability2.
Effective recipient to donor traceability requires that the traceability pathway commences in the recipient’s patient record, and that the recipient has the means to locate and access that record. Developments in electronic patient records are progressing rapidly in many countries. The structure and content of such records are variable, but there is a clear international convergence towards using Application Programming Interfaces (API) that comply with the Representational State Transfer (REST) architecture3 to provide platform-independent interoperability, and the adoption of HL7 Fast Healthcare Interoperability Resource (FHIR)4,5 as the standard for information transfer. Many of the major healthcare information systems are supporting such improvements in data interoperability bringing closer the realization of a single patient health record that can access information across health services.
Since early 2022, ICCBBA and other experts in transfusion medicine informatics have been working with the HL7® FHIR® Orders and Observations Committee in order to develop a mechanism to capture information on blood products (and other medical products of human origin) using FHIR resources. This work is now well advanced and the BiologicallyDerivedProduct resource in FHIR is capable of holding full information on a product including the unique donation identification number, product code, expiration date, blood group, and red cell antigen profile. Blood establishments adopting this resource will be able to provide REST-based API access thus making the information available to all authorised systems.
The FHIR Procedure resource is already widely used to record details of procedures performed on, with, or for a patient, including surgical procedures. Because it is already well-established in healthcare systems, use of the Procedure resource to capture information on transfusion events will provide an efficient and cost-effective means to achieve both improved traceability and recording of transfusion outcomes.
It is possible to capture the unique identifiers of blood products used as part of the Procedure record of the associated clinical intervention. The existing Procedure resource has a repeating element ‘used’ which is suitable for capturing identifiers of blood products. This would provide a traceability link from the electronic patient record, via the clinical procedure, to the identifiers of the blood products transfused. Provided unique identifiers (e.g. ISBT 128) are being utilized for blood products, it is possible to identify the Blood Centre that provided the blood product and trace back to the donor.
However, a more effective solution is to capture each blood transfusion event as a Procedure in its own right. The FHIR model allows a hierarchy of procedures such that one procedure can point to another procedure that it is part of. It will therefore be possible to create a procedure for the transfusion event that references the patient, the blood products transfused, and, if appropriate, the overarching procedure that the transfusion event was associated with. The advantage of this approach is that information can be captured regarding the transfusion event itself, including clinical outcome (as recommended in the IBI report) and adverse events. The Procedure resource already has elements that can capture: the request for transfusion; the date and time of occurrence; the outcome of the procedure; and complications following the procedure. Outcome and complication information can be captured in coded format where appropriate coding systems exist, or as text. Use of an internationally standardized coding for adverse events would significantly improve haemovigilance data capture and analysis.
The next release of HL7® FHIR®, Release 6, is widely regarded as the next normative version to be implemented by suppliers. It is important that the transfusion community actively engages with hospital IT system suppliers to make them aware of the need to capture transfusion information and make it accessible as FHIR resources so that appropriate functionality is included in new software releases.
References
- European Union. Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application. Accessed 18 Oct 2024
- UK Government. Infected Blood Inquiry Report (Chapter 6.10) Last accessed: 24 Oct 2024
- Fielding RT. Architectural styles and the design of network-based software architectures. University of California, Irvine; 2000. Last accessed 18 Oct 2024
- HL7 International. Fast Healthcare Interoperability Resource Last accessed 18 Oct 2024
- HL7 International, Firely. 2024 State of FHIR Survey Results. Last accessed 24 Oct 2024
