Biological Risk Assessment

Biological Risk Management for Point-of-Care Testing Sites

Key points

  • When performing a biological risk assessment, a diverse risk assessment team ensures multiple viewpoints and reduces bias.
  • Plan and conduct risk assessments before testing begins and whenever changes occur.
  • Use informal risk assessments for regular discussions about potential risks and controls in testing settings.

Before you start

Create a risk assessment team

You and the people who work at your POC site should form a risk assessment team. When you include multiple viewpoints, you can reduce the possibility that the input from one or two people will strongly influence the process. This team could be made up of managers, testing staff, safety professionals, facility staff, and other employees familiar with the site-specific and activity-specific testing activities.

Choose the right time for risk assessment

Plan ahead and do a risk assessment before testing begins. Repeat the risk assessment when any change is introduced into your process, such as changes in practices, personnel, equipment, or testing location.

Select the right risk assessment type

This guidance focuses on informal risk assessments, which can be performed in many POC testing settings. This usually involves short discussions among staff about potential risks and the controls to reduce those risks. They should occur weekly, daily, or even throughout the day, depending on how much testing is happening at your site. Formal risk assessment guidance can be found here.

Risk assessment steps

Your risk assessment team should consider hazards, specific testing steps, existing controls, competency and experience of POC testing staff, and the testing site.

To identify the hazards in each testing task that must be completed, ask what, where, and how the testing is occurring, and who is doing the work. Then, determine what could go wrong in every step of the procedure and the risks, such as an injury or an exposure to biological material (a pathogen) that could make you sick. One way to accomplish this is to perform a job hazard analysis (JHA). The federal Occupational Health and Safety Administration (OSHA) published an example of this tool; look on pages 4–12. A JHA is a technique you can use to break down specific tasks to identify hazards and risks before they occur.

Examples of hazards vs. risks

Graphic showing the difference between a hazard and a risk, including the hazard of scissors and the risk of cut skin.
A hazard is a source of potential harm, while risk is the likelihood of incidents or harm happening.

It is important to remember the difference between hazard and risk. Hazard is a source or situation with the potential for causing harm, while risk is the combination of the likelihood of something bad occurring and the harm if that event occurs.

Step 2a. Characterize the risks

In this step, you start by considering how likely it is that the undesirable event will occur, and what the consequences would be if it occurs.

Likelihood addresses everything leading up to an event happening. Consequence addresses everything that results from that event happening.

Graphic showing pre-incident likelihood and post-incident consequences for risk assessment.
Likelihood is evaluated pre-incident, while consequences take place post-incident. (Source: Sandia National Laboratories Biosafety and Biosecurity Risk Assessment Technical Guidance Document, 2014.)

Likelihood

Some factors to consider that can affect how likely an undesirable event may be include:

  • Biological agent factors
    • Ways that biological organisms can enter your body by splashing small liquid droplets into your eyes or nose, inhaling tiny particles suspended in air, getting harmful organisms into your mouth, or by penetration through the skin from a needlestick
  • Testing site factors
    • The place where testing happens, whether in a building or outside (physical infrastructure), the type of facility, presence of safety controls, type of equipment used, functioning and reliability of ventilation systems and electrical power
    • Procedural: existence of policies and training, availability of appropriate personal protective equipment (PPE), work procedures that may produce aerosols or cause cuts by using sharps, the types and complexity of procedures being conducted, and the competency and experience of those performing the tests

Consequences

Some factors to consider that can affect the consequences of an undesirable event include:

  • Biological agent factors
    • How easily the infection can spread from person to person (contagiousness)
    • How severe the disease could be
  • Human factors
    • Willingness of the testing site staff to receive medical treatment that could reduce how sick they might get if they are exposed to hazards
    • Understanding the procedures to follow if something goes wrong and how they can limit the consequences of an adverse event

Step 2b. Prioritize the risks and determine if risks are acceptable

The risk assessment team determines how it defines "likelihood" and "consequence." One example of how likelihood and consequence are defined is:

Likelihood

  • Low: Unlikely to occur. Highly trained and experienced staff, comprehensive safety procedures and controls in place
  • Moderate: Might occur. Moderately trained staff, some procedures and controls in place
  • High: Likely to occur. Staff lack sufficient training, few safety procedures and controls in place

Consequence

  • Negligible: Trivial incident or near miss that requires reporting and follow-up
  • Moderate: Incident that causes harm and requires medical intervention and treatment or has environmental consequences
  • Severe: Potential fatality, serious illness, secondary transmission, or significant environmental impact

Once likelihood and consequences are defined, POC testing risk assessment teams should determine what level of risk is acceptable. If the risks for a particular activity are not acceptable to leadership, then the activity should not occur.

Determining acceptable risk is a subjective process, meaning that each person or organization will use their own judgment. At your site, your team will determine what risk levels are considered acceptable and what risk levels are considered unacceptable. If you determine the risks are acceptable, proceed in your work with the existing controls. For the risks considered unacceptable, stop work until you can put in place additional risk-reducing controls that bring risks to an acceptable level.

If your risk assessment team finds some risks unacceptable, develop a mitigation control plan (see an example from the Occupational Safety and Health Administration – OSHA). Additional controls can reduce the likelihood or consequences of specific risks and bring them to a level that is acceptable. For example, additional PPE and additional training and monitoring could significantly reduce the risk of accidental exposure and infection during POC testing.

Your risk assessment team should review and evaluate the effectiveness of implementing additional controls, such as the use of PPE. For more information on mitigation and evaluation of the performance of controls, refer to this document from the World Health Organization: WHO Risk Assessment Monograph.

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