Tracing the gaps: A global snapshot

Traceability of blood components ensures patient safety, allowing bidirectional tracing of donors and recipients. Records must be kept for defined intervals and stored safely to ensure data integrity. Compliance must be regularly assessed, with clear accountability and actions for deficiencies. All transfusion staff must be trained in traceability to promote safe practices. The global survey aimed to identify the current status of blood components traceability.

International Society of Blood Transfusion (ISBT) Working Party on Haemovigilance in collaboration with International Haemovigilance Network (IHN) and Serious Hazards of Transfusion (SHOT) conducted a global survey in traceability, built using Online Surveys by Jisc and distributed to the six World Health Organization (WHO) regions. Responses were analysed using Microsoft Excel.

There were 212 responses from 43 countries. In 201/212 (95%), a law or regulation for traceability was reported, and in 189/201 (94%) traceability was bidirectional. Retention periods for records were variable, with ≥30 years being the most common (117/195; 60%). The Ministry of Health (118/212; 56%) and/or regulatory bodies (189/212; 89%) were most often the responsible organizations for monitoring traceability. Training in traceability for transfusion staff was reported in 139/212 (66%). In 32/212 (17%), there was at least one recall where a donor or recipient could not be traced. Records stored in computers (28/212; 13%), hard copies (22/212; 10%) or both (132/212; 62%) were reported. Of those with legacy systems (84/160; 53%), 18 stated that these were not safely managed. A haemovigilance system or equivalent was reported in 171/212 (81%) responses. The main challenges identified were unavailability of information technology (139/212; 66%) and staffing issues (137/212; 65%).

This survey highlights wide global variation of traceability practices and highlights critical risks requiring urgent action.