How do we determine if our record keeping permits traceability of implanted tissue?

Any examples are for illustrative purposes only.

The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:

• Report potential disease transmission to the recipient when notified by the donor source facility
• Report adverse patient reactions to the donor source facility
• Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.

An organization could become aware of the potential for an adverse event from either the donor facility or the recipient. For example, the donor facility may notify the organization of a suspected infectious disease associated with a particular tissue source. The organization would need to promptly identify and notify all recipients and quarantine any implicated tissue not yet implanted. Alternatively, the patient's physician might notify the infection control nurse of a post-op infection associated with the tissue implant.

Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.