Traceability

The importance of effective and timely traceability in both the recall of substances of human origin (blood, cells, tissues and organs) implicated in infectious transmission, and in the prevention of inappropriate use of substances of human origin is now well recognised. However, traceability remains poorly understood and inadequately controlled in many cases. In particular there is: a lack of appreciation of the complexity of the traceability pathway; a fragmented approach to traceability; and, an assumption that traceability data is static. The traceability path for a single tissue donor may involve dozens or even hundreds of different organizations, each responsible for one segment of the path. Whilst responsibility within each organization may be clearly defined, responsibility for maintaining the interfaces between organizations is often less clear. Traceability is seldom regarded in a holistic manner, the assumption being made that if each segment of the pathway is correctly maintained then the full path will be intact. End to end traceability audits are not routinely performed, and the only true test of the trail occurs when recall is required—often with inadequate results.