Lean Six-sigma method: application in Chemotherapy Reconstitution Unit (URC)

Introduction
The increasing activity of chemotherapies of URC (38% in 10 years) impacts their time of availability in day hospital (DH) and patient management. A quality management method, Lean Six Sigma (LSS), has been applied.

Objective
Optimization of the time of availability of chemotherapies in DH by an LSS approach.

Materials and methods
Twenty eight preparations have been followed for 3 weeks using 3 tracer molecules: 1 monoclonal antibody (pembrolizumab) and 2 cytotoxics (oxaliplatin and paclitaxel). Four steps of the LSS (define, measure, analyze, implement) were applied using tools: flow mapping, spaghetti diagram, crossing time and brainstorming.

Results
The flow mapping revealed a clutter of the isolators. Three proposals suggested : a more proper use of transfer airlocks in order to swap leftovers between isolators; prioritized production of chemotherapies according to the time of administration with Chimio^® software setting; sterilization of 4 trays maximum per cycle in relation to our average chemotherapy manufacturing time (4.5 min).
The analysis of the operators’ flows has allowed us to modify the storage of medical devices in the unexploited areas of the controlled atmosphere zone. The extemporaneous dispatch of the bags remedies their storage and many displacements caused by the grouped dispatch of the chemotherapies of the same protocol.
The average pharmaceutical validation time is 6 min and the tray is placed in sterilization after 7.7 min. Chemotherapies are delivered in an average of 51 min. The highest activity is between 9am and 12am representing 53% of medical validations. Delayed activity was observed after 12 am. The team’s schedule has been reorganized.

Discussion
Trays cluttering up the isolators are due to the lack of prioritization of chemotherapies. Communication within the team is crucial for the management of the transfer airlocks and the organisation of the production of chemotherapies.
The DH’s service estimates that the time of availability of chemotherapies is long, but from this project it’s acceptable basing to the recommendations of the French Oncology Pharmacy Society (60 min). Moreover, physicians were on average 28 min late for their appointments. The optimization of patient care must be global.

Conclusion
The partial reorganization of the circuit should contribute to a better fluidity of the production of the 250 daily preparations.