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

Alessandro Morabito,1 Piera Maiolino,2 Stefania D’Auria,3 Roberta D’Aniello,2 Claudia Sandomenico,1 Agnese Montanino,1 Marina Casale,2 Giuliano Palumbo,1 Vincenzo Sforza,1 Raffaele Costanzo,1 Giovanna Esposito,1 Giuseppe Caropreso,4 Anna Manzo,1 Arturo Capasso,5 Bruno Barba,2 Carlo Pannone,3 Loredana Campitiello,3 Antonio Nardone,6 Maria Triassi,6 Simona Damiano,1 Cira Antonietta Forte,1 Amalia Rocco,1 Gianfranco De Feo,7 Maura Tracey,8 Giacomo Pascarella7 1Thoracic Department, Division of Thoracic Medical Oncology, Istituto Nazionale Tumori “Fondazione G. Pascale”, IRCCS, Napoli, Italy; 2Department of Strategic Health Services, Pharmacy, Istituto Nazionale Tumori “Fondazione G. Pascale”, IRCCS, Napoli, Italy; 3Department of Strategic Health Services, Hospital Direction, Istituto Nazionale Tumori “Fondazione G. Pascale”, IRCCS, Napoli, Italy; 4Department of Precision Medicine, Division of Medical Oncology, Università of Campania “Luigi Vanvitelli”, Napoli, Italy; 5Department of Finance and Management, Wroclaw School of Banking Wyzsza Szkoła Bankowa, Wrocalw, Poland; 6Department of Public Health, Università Federico II, Napoli, Italy; 7Department of Scientific Directorate, Istituto Nazionale Tumori “Fondazione G. Pascale”, IRCCS, Napoli, Italy; 8Department of Strategic Health Services, Rehabilitative Medicine Unit, Istituto Nazionale Tumori “Fondazione G. Pascale”, IRCCS, Napoli, ItalyCorrespondence: Giacomo Pascarella, Department of Scientific Directorate, Istituto Nazionale Tumori “Fondazione G. Pascale”, IRCCS, Via Mariano Semmola 53, Napoli, 80131, Italy, Tel +39 08117770219, Fax +39 0817702938, Email g.pascarella@istitutotumori.na.itBackground: 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.Keywords: risk management and assessment, risk matrix, chemotherapy risk, ISO 31000:2018, Day Hospital, lung cancer