Implementation Guide - Use of the Processing Facility Information Code [Data Structure 033] v1.1.0

Multiple facilities may be involved in the collection or recovery, processing and labelling of a medical product of human origin. Donation Identification Numbers (DINs) contain the identity of the organisation that assigned the DIN (often the organisation that collects the tissue graft). However, there is also a need to record the facility involved in processing and labelling the final graft. The Processing Facility Information Code [Data Structure 033] is designed to electronically identify the facility responsible for labelling the finished graft as part of the product identification.

This document provides specific guidance for cellular therapy and tissue (including ocular) facilities to implement and use the Processing Facility Information Code [Data Structure 033]. The use of this data structure for tissues and cells is not currently required in most situations. However, future changes to how DINs are assigned and used may result in the need for this data structure for traceability purposes. In the meantime, some tissue and cell facilities may choose to implement this data structure for other reasons.

This document is a supplement to the ISBT 128 Standard Technical Specification (ST001).

Main sections:

- Background

- Processing Facility Information Code [Data Structure 033]

- When should this data structure be used?

- Traceability issues

- Standardised ISBT 128 Product Description Code versus facility-defined product code

- Product labels

- Information for software developers