Implementation of ISBT 128 labelling, an Australian experience

Background & Aim Background The Pathwest Bone Marrow Transplant Laboratory (BMTL) is the newest addition to the recently constructed Fiona Stanley Hospital Perth, WA. The laboratory was constructed to fulfil the need for a haemopoietic processing laboratory to service the adult stem cell programme, which is the only programme in the state to perform allogeneic stem cell transplants. The BMT Laboratory established a goal to attain FACT accreditation, ISBT 128 labelling was necessary to gain accreditation. Aim To complete the implementation, validation and quality plan for an efficient and cost effective ISBT 128 labelling system. This will allow the processing laboratory to receive, process, store and distribute haemopoietic stem cell products to meet the demands of the hospital, the regulatory bodies (FACT) and the larger international community as a distribution site (ABMDR). Methods, Results & Conclusion Methods The flow chart Pathwest followed in the implementation of ISBT 128 labelling contains 9 key steps, Change Control, Equipment (Equipment, Software, Supplies), ICCBBA Registration, Planning, Validation, Training, Go Live, Review and finally Audit of the system. Each step of the setup required completed documentation of testing and validation to sufficiently satisfy regulatory agencies and to ensure the labelling system complies with strict quality assurance programs. Results The BMT laboratory completed its implementation of ISBT 128 labelling at the end of September 2015 taking 6 months to plan and implement with the first ISBT 128 labelled haemopoietic HPC(A) graft processed and distributed in the same month. A total of 6 months was spent on the installation, validation of equipment and training of staff . BMTL was audited by FACT in June 2018. Conclusion The introduction of an ISBT 128 labelling system has required an implementation plan which covers the importance of setting out key steps and the review of its effect on procedures to ensure impact on the laboratory systems are kept to a minimum.