GS1 in touch

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Update on traceability in healthcare

By Janice Kite on 20 January 2010
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Global standards to achieve end to end traceability

The Traceability in Healthcare work group’s mission is to develop both process and technical standards necessary to achieve end to end (raw materials to patient care) traceability in the global healthcare supply chain – both track forward (downstream) and trace backward (upstream).

This suite of process and technical standards will be the foundation for achieving an incremental implementation of traceability systems that enable patient safety, regulatory compliance, supply chain safety and integrity.

What is our vision of traceability? It is to have full actionable visibility of all items in healthcare, from point of production to point of use, across all geographies globally.

More specifically, we envision a world where:

  • all authentic items are identified with the appropriate GS1 identifier (e.g. GTIN) at point of production
  • identification remains with/on the item throughout its intended useful life
  • all physical locations are identified with the appropriate GS1 identifier (e.g. GLN) across the entire supply chain
  • agreed master data is captured and shared (e.g. via GDSN) on demand amongst trading partners
  • agreed event data is captured and shared (e.g. via EPCIS) on demand amongst traceability stakeholders

…so that:

  • items can be tracked (forward / downstream) across the entire supply chain (production to use) in real time on demand
  • items can be traced (backward / upstream) across the entire supply chain (from current location back to the producer) in real time on demand
  • Electronic Health Records (EHRs) are updated with agreed traceability information
  • counterfeit products cannot enter the legitimate supply chain without being immediately detected
  • a product recall would be fast, efficient and effective.

Accomplishments and developments
In 2009, the Global Traceability Standard for Healthcare (GTSH) and its implementation guideline were published; 114 members from 34 countries representing all stakeholder groups have contributed to their development.


Currently, one important sub-team of the work group is devoted to Chain of Custody/Chain of Ownership (CoC/CoO) issues. These are core use cases for traceability. The team is continuing to focus on regulatory requirements for CoC/CoO as well as performing a gap analysis against EPCglobal data exchange and visibility standards. The work group will shortly finalise CoC/CoO business requirements to ensure they cover diverse national and regional requirements as well as Product ID Authentication and Product Recall use cases. The work group will also create a Global Traceability Conformance (GTC) Checklist for Healthcare based on a recent audit at the St. James’s Hospital in Dublin, Ireland.

Contact
For more information or to join one of the above work teams, contact Janice Kite


 


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