In Focus
Traceability guidelines
Recommendations from the WPIT
The need for bi-directional traceability for blood and other medical products of human origin is well recognized and required by regulation in many countries.
However, traceability over long time periods is challenging and complex. The ISBT WPIT has published guidelines to help with the management of traceability through the transfusion chain and these provide a useful tool for organizations to assess their own traceability systems.
The focus of the guideline is on blood, blood components and cellular therapy products. It does not address the traceability of plasma derivatives beyond supply of plasma to fractionators. The importance of traceability to patient safety is explained, and the pre-requisites to an effective system described. Examples demonstrate how the traceability pathway can become very complex involving multiple organizations, and changes in identifiers as a result of product pooling.
Two aspects of traceability are defined. Core traceability provides the chain of identifiers allowing tracking from donor to recipient, and recipient to donor. Extended traceability links other information to the core chain, including who did what, where and when on a particular process step, and what supplies, reagents and equipment were used. The amount of extended traceability information captured varies widely.
Traceability should be embedded within the quality system of the organization. There should be an overarching traceability policy that covers how traceability is established, and how it is maintained. A named individual or position in the organization should be identified as having overall responsibility for traceability and this should be clearly stated in the job description.
Training in traceability should be required for all staff responsible for elements in the transfusion chain, and for all informatics staff responsible for the ongoing maintenance of databases and computer systems.
The need for traceability to be maintained for very long time periods (e.g. 30 years in EU) presents significant challenges for automated systems as technology develops rapidly and systems are upgraded or replaced. The guideline examines these challenges and explains how they can be addressed in a manner that retains security and confidentiality. The need for forward planning to ensure that future system changes accommodate traceability needs is emphasized.
Regular audit should be carried out on traceability, both within organizations, and on an end-to-end basis to confirm that the donor to recipient bi-directional link remains intact. These audits should cover the entire retention period, and so should include audit of traceability paths of historic events to confirm that ongoing traceability is being effectively managed.
The WPIT recommends that organizations use these guidelines to perform gap analysis on their own traceability systems in order to identify areas for improvement.
