An ISO 31000-Based Risk Matrix for Risk Management in Anticancer Drug Prescription, Compounding, and Administration for Lung Cancer Patients Treated in a Day Hospital Setting

Background: This study aims to identify and reduce risks that could negatively impact patient safety and organizational aspects related to the different phases of anticancer drug therapy for lung cancer patients in the Day Hospital (DH) care. Methods: From April 2023 until February 2024, a team of multi-disciplinary healthcare professionals of the National Cancer Institute of Naples, Italy, used a modified Delphi approach to identify the care process, the main activities and related risk factors. The severity of these harms and the probability of their occurrence were assessed by applying a 5×5 semi-quantitative ISO 31000:2018 (ISO 31000) risk matrix. Multiple improvement actions were identified and adopted by the team to reduce the risks to acceptable levels. Results: Nine main activities, 19 correlated potential risks (10 risks for patient safety domain; 53.0%) (9 risks for organizational area; 47.0%) and 19 mitigation measures were identified. The highest risk levels were recognized in the organizational area for: (i) DH Outpatient Visits, due to delays in patients check-in or lab test results or problems with the prescription software; (ii) anticancer drugs administration, for the unavailability of chemotherapy chairs or lack of dedicated nursing staff. Conversely, risk levels for patient safety area were low overall, because several control measures were already in place. Once the mitigation measures were implemented, a new semi-quantitative risk analysis was performed. Risk levels for organizational area changed from a 44.4% to 0.0% in high level, from 44.4% to 67.0% in moderate level, and from 11.2% to 33.0% in minor level. Risk levels for safety areas did not modify for high level (10.0%), but changed from 50.0% to 10.0% in moderate level and increased from 40.0% to 80.0% in minor level. Conclusion: ISO 31000 risk management framework applied to lung cancer DH care could improve both organizational and safety objectives in oncology.