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An ISO 31000-Based Risk Matrix for Risk Management in Anticancer Drug Prescription, Compounding, and Administration

Alessandro Morabito1, Piera Maiolino2, Stefania D'Auria3

  • 1Thoracic Department, Division of Thoracic Medical Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Napoli, Italy.

Risk Management and Healthcare Policy
|March 3, 2026
PubMed
Abstract

Insights

This study reduced risks in lung cancer Day Hospital care by applying ISO 31000 risk management. Implementing mitigation actions significantly lowered organizational risks and improved patient safety outcomes.

Area of Science:

  • Oncology
  • Healthcare Management
  • Patient Safety

Background:

  • Lung cancer patients undergoing anticancer drug therapy in Day Hospitals (DH) face potential patient safety and organizational risks.
  • Identifying and mitigating these risks is crucial for optimizing care delivery.

Purpose of the Study:

  • To identify and reduce risks impacting patient safety and organizational aspects during lung cancer therapy in a Day Hospital setting.
  • To implement and assess the effectiveness of risk mitigation strategies.

Main Methods:

  • A modified Delphi approach was used by a multidisciplinary team to identify care processes, activities, and risk factors.
  • A 5x5 semi-quantitative ISO 31000 risk matrix assessed harm severity and occurrence probability.
  • Improvement actions were identified and adopted to reduce risks.

Main Results:

  • 19 potential risks were identified, with 10 affecting patient safety and 9 impacting the organization.
  • Highest organizational risks included DH outpatient visits and drug administration.
  • Post-mitigation, high-level organizational risks decreased from 44.4% to 0.0%, and moderate patient safety risks reduced from 50.0% to 10.0%.

Conclusions:

  • The ISO 31000 risk management framework effectively improved both organizational and safety objectives in lung cancer Day Hospital care.
  • This systematic approach enhances the overall quality and safety of oncology patient management.
Keywords:
Day HospitalISO 31000:2018chemotherapy risklung cancerrisk management and assessmentrisk matrix

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