Improving Risk Management by Learning from Adverse Events: Report on One Year of COVID-19 Vaccination Campaign in Verona (Northeastern Italy).

ABSTRACT

BACKGROUND: The COVID-19 mass vaccination campaign posed new challenges not only from a healthcare perspective, but also in terms of distribution, logistics, and organization. Managing clinical risk in off-site vaccination centers during a pandemic provided a new opportunity for the training and acquisition of competencies through continuous learning from adverse events. The aim of this report, based on a review of activity, was to identify the most recurrent and high-risk failures of the vaccination process in a mass vaccination center. METHODS: Adverse events and near misses reported during the first 11 months of activity (February 2021-January 2022) in the mass vaccination center of Verona (Italy) were evaluated. RESULTS: From 15 February 2021 to 17 January 2022 the center administered about 460,000 doses to the population and nine adverse events and one near miss were reported. Most of the events were errors in vaccine administration, either in principle, dosage, or timing with respect to the indicated schedule. All events had minor outcomes. Communication errors, inadequate training, and general organizational issues were the most recurrent factors contributing to the events. CONCLUSIONS: Risk mitigation during mass vaccination in temporary sites is an essential element of a successful vaccination campaign. The reporting of adverse events should be encouraged in order to obtain as much information as possible for a continuous improvement of the activity.