2.3. Risk Assessment
This protocol is extracted from research article:
COVID-19 Impact on Musculoskeletal Regenerative Medicine Research: Maintaining Lab Continuity
Int J Environ Res Public Health, Jun 5, 2021; DOI: 10.3390/ijerph18116110

The risk assessment protocol utilized to control COVID-19 spread was developed by integrating the O*NET database of the US Bureau of Labor of Statistics and data from the Italian working context that has been analyzed and released from the Italian Institute for insurance against accidents at work (Istituto Nazionale per l’Assicurazione contro gli Infortuni sul Lavoro, INAIL) and the National Institute of Statistics (Istituto Nazionale di Statistica, ISTAT) [22,23]. This model is based on three variables: exposure, proximity, and aggregation (Table 1).

Critical variable to consider for SARS-CoV-2 risk assessment.

The team decided not to follow a template for this assessment but proposed a procedure that is common in most institutions’ risk assessments. In that way, the information can be easily transferred and the method adjusted to the different organizations. The procedure proposed to manage COVID-19 risk encloses the steps described below.

Before undertaking the risk assessment, the context was defined in terms of areas, personnel, and activities. The team considered not only the research lab context but the whole institute, since the surrounding environment may affect a research lab’s hazards and risks. The Rizzoli Orthopedic Institute is a highly specialized hospital and research facility in the field of orthopedics and traumatology. It is also the venue of University teaching. The fact that The Rizzoli Orthopedic Institute comprises both treatment and research activity allows the results of scientific research to be easily translated into clinical practice. From a logistical point of view, it is organized in three close locations: the hospital giving patients medical and surgical care, the polyclinic providing specialist examinations, and the research center, which besides the labs houses also the management and the administrative offices. Connected to the research area, there is the animal facility, which is a unit that deals with housing and breeding animals and experiments on them in compliance with current regulations. Such an organization allows better communications between researchers and clinicians and the translation of research results into clinical practice.

To simplify the analysis, the team split up such a complex context into three sub-contexts: general, extra-lab, and research lab. The general sub-context is represented by the hospital, the polyclinic, and the management and administrative offices. What is defined as a “research laboratory” is made up of two different environments: extra-lab areas where bibliographic research, writing of scientific works, or projects meetings and teaching activities take place; and lab areas where experiments are carried out (Figure 1).

Sub-contexts from which to start for risk assessment: general, extra-lab, and research lab. The general sub-context is represented by the hospital, the polyclinic, and the management and administrative offices. What is defined as a “research laboratory” is made up of two different environments: extra-lab areas where bibliographic research, writing of scientific works, or projects meetings and teaching activities take place; and lab areas where experiments are carried out.

Due to the proximity and continuous personnel passing between the three sub-contexts, the team identified for the researchers three levels of risk assessment corresponding to the identified sub-contexts: general, extra-lab, and (research) lab. Details are listed in Table 2 in terms of personnel and activities.

Levels of risks assessment to consider for sub-context, operator, and activity.

The source of exposition that may cause harm (COVID-19) was defined.

The risks caused by the SARS-CoV-2 virus have been described.

The team considered what measures, if any, were already in place to control the biological risk and if they were adequate. Then, the group decided if more measures can be applied. As a final step, the team evaluated the biological risk containment measures already put in place before the pandemic in comparison with the addition emergency ones against SARS-CoV-2.

The control measures to apply to mitigate the COVID-19 risk were categorized utilizing the Hierarchy of Controls, which is a risk management tool used around the world. It can be described as a flow that goes from the most effective measure to the least: Elimination, Substitution, Isolation, Engineering controls, Administrative controls, and Personnel Protective Equipment (PPE) (Table 3) [24].

Hierarchy of Controls representation.

The decisional flow utilized for the managing of the Hierarchy of Controls to mitigate SARS-CoV-2 is detailed in Figure 2. The first evaluation is the possibility to eliminate/substitute the hazard to mitigate the risk. Otherwise, engineering and administrative control measures should be applied. Then, there is a second decisional moment: the possibility of physical distancing. If not maintained, the use of PPE should be evaluated.

Decisional flowchart for the managing of the Hierarchy of Controls to mitigate SARS-CoV-2. The flowchart shows the steps as boxes and their order by connecting the boxes with arrows. The boxes with rhombus shapes are decisional steps.

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