Operating procedure for the healthcare management of Ebola virus disease cases
Establishment of procedures for managing suspected or confirmed cases, biological sample transport, and biocontainment transfers
The Civil Protection Department and the Ministry of Health have defined a Standard Operating Procedure (SOP) for managing suspected or confirmed cases of Ebola virus disease (EVD), including the transport of biological samples and the potential biocontainment transport of patients.
This document provides a national operational framework for coordinating healthcare, logistics, and biosafety activities related to disease management, and outlines the roles, responsibilities, and coordination mechanisms among the parties involved. The procedure was developed to ensure a consistent approach nationwide and to facilitate coordination among the Italian National Health Service, the relevant administrations, and the National Civil Protection System in activities requiring specific prevention and safety measures.
Ebola virus disease is a rare but serious infectious disease caused by viruses belonging to the genus Ebolavirus.
Transmission occurs through direct contact with the blood, secretions, or other bodily fluids of infected people or animals. It is not transmitted through the air, and current evidence indicates that an infected person is not considered contagious before symptoms appear.
The risk of infection is considered very low if the recommended prevention and control measures are followed. Authorized vaccines are also available for the viral variant known as “Zaire ebolavirus.”
People travelling from the areas identified by the Ministry of Health must submit a specific notification to the Prevention Department of the Local Health Authority (ASL) within 24 hours of entering the country.
Based on this report, an epidemiological and clinical assessment of the individual is conducted to classify the risk level and identify the most appropriate measures. The process includes:
- Epidemiological and clinical assessment of the individual;
- Classification of the risk level;
- Implementation of the required public health surveillance measures;
- Any necessary diagnostic tests;
- Initiation of the biocontainment protocol where necessary
The Regions and Autonomous Provinces identify one or more reference healthcare facilities for infectious diseases and a regional infectious disease specialist.
These coordinators ensure coordination with the "Lazzaro Spallanzani" National Institute for Infectious Diseases in Rome, the national reference centre, to ensure uniform management of reported cases and to support complex clinical and diagnostic evaluations.
When clinical and epidemiological assessments warrant it, procedures are initiated for the collection and transport of biological samples to authorized laboratories. These activities are performed in accordance with specific safety protocols and must ensure rapid transfer times.
If a Region or Autonomous Province is unable to arrange for the transport of samples on its own, it may request support from the National Civil Protection Service through the CROSS (Remote Centre for Health Rescue Operations) system.
As provided for by national procedures, a patient may be transferred to an authorized healthcare facility using high-level biocontainment transport systems. The decision to initiate the transfer is based on a specialist evaluation that takes into account the patient’s clinical, epidemiological, and diagnostic profile.
Clinical and healthcare responsibility remains with the Italian National Health Service, while the National Civil Protection System may provide logistical support for these operations.
The procedure also regulates the handling of suspected cases identified on flights coming from areas affected by outbreaks of the disease or involving individuals who have stayed in such areas within the previous 21 days.
In these situations, within Italy, the aircraft lands at the Rome Fiumicino International Airport, where the procedures established by the Ministry of Health are activated, followed by biocontainment transport to the designated healthcare facilities.