Computer blackout (CBO) in a chemotherapy preparation unit (CT): how to cope?

4 October 2023

J. Bodet, G. Lafci, M. Abele, A. Villain, I. Sakji, G. Marliot
Centre Oscar Lambret, Lille, France

The entire CT circuit is dematerialized and managed at our hospital center by CHIMIO® software, with in-process gravimetric control and data-matrix reading. The latter enables all stages of the CT circuit to be traced, from medical prescription to administration in the department. Stock, product, preparation shelf life, storage methods, CT protocols, and patient records (PR) are computerized.
Although computerization makes the circuit secure and traceable, it is vulnerable to a CBO. This work aims to ensure continuity of care in the case of a CBO thanks to an alternative, secure preparation circuit.

The stages that could be affected by a CBO were identified collectively. In the event of a CBO, the technical and biomedical departments ensured that the air handling unit in the controlled-atmosphere zone and the isolators functioned correctly. A new detailed CBO circuit has been drawn up and implemented. The necessary material and human resources were defined. A computer and dedicated printer were provided. A CBO simulation was carried out in the CT preparation unit to evaluate this new circuit.

The procedure defines five work zones (WZ) impacted by a CBO: pharmaceutical analysis (WZ1), production sheet/patient labels (WZ2), double pharmaceutical control (WZ3), preparation (WZ4), and release (WZ5). An operating procedure has been drawn up for each zone. The elements required in a CBO have been defined: dilution sheets, medical device thesaurus, inventory sheets, prescriptions, and office equipment. An Excel® file containing molecular and preparation data (stability, storage conditions, operating procedures, and preparation devices) has been developed; it automatically generates, in paper format: a manufacturing sheet, labels, back labels, and a Z3 and Z5 stage control traceability sheet.
USB sticks containing CT protocols, daily PR, Excel® files, and CBO documents are available. One pair per isolator is required: manufacturing/double visual inspection, and data recording. The simulation showed that the CBO circuit worked well and highlighted the need to create a procedure for triggering it.

This anticipation work ensures the continuity of care and the security of our production. A larger-scale simulation, including care services, is planned to ensure proper coordination. The maximum production capacity, the reintegration of PDs, and the generation of Fichcomp during the return to normal are currently being defined.
Mesh terms: IT security, continuity of care, medication preparation

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