Biological Risk Assessment: General

Considerations for Laboratories

Introduction
What is it?

CDC’s Division of Laboratory Systems knows that incidents involving

biological, chemical, physical, and radiological hazards can have a significant
impact on the safety and health of those who work in laboratory settings.
Risk management is a continuous process to identify, assess (evaluate),
control, and monitor risks. The risk assessment components of the overall
risk management process are:
Risk Management Process
See ISO 35001external icon for the complete risk management process.
Process Steps

Step 1:

Identify the hazards and risks.

Step 2:

Evaluate the risks.

Steps 3-4:

Implement a risk mitigation plan, as needed.

Step 5:

Evaluate effectiveness of controls.

Why is it needed?

Many laboratory activities have been linked to undesirable events, including

laboratory-acquired infections. These can result from direct contact of the
infectious agent with mucous membranes of the eyes, nose or mouth via
sprays, splashes, or droplets; inhalation of infectious aerosols generated
during activities such as mixing and centrifugation; or from percutaneous
inoculation via sharps, needle sticks, or non-intact skin (e.g., scratches and
cuts).

To minimize risks and provide a safe work environment, a risk assessment

should be performed to evaluate what could go wrong by determining the
likelihood that an undesirable incident (e.g., injury, exposure) may occur and
the consequences (e.g., infection or disease) if that undesirable incident were
to occur.
When is it performed?

Formal risk assessments should be performed before work begins, and

repeated when any change is introduced into the activity (e.g., changes in
practices, personnel, instrumentation, or facilities). Informal risk
assessments, which include short discussions among staff about current
risks and mitigations, should occur much more frequently, ideally daily.
Who is involved?

A team should perform risk assessments to ensure various perspectives are

considered and to reduce bias. This team could be comprised of senior
leadership, clinical laboratory scientists, safety professionals, facility
engineers, and others familiar with the site-specific and activity-specific
laboratory and testing activities.

How is it conducted?
Overview of the Risk Assessment Process

In general, risk assessments can be broken down into Steps 1-2 in the figure
above. The risk assessment should include considerations about the hazards
(e.g., biological agent), the specific processes and procedures, existing control
measures, the facility and testing environment, and the competency of the
testing personnel.
Step 1: Identify the hazards and risks

In this section, learn how to answer these questions:

• What, where, and how is the work occurring?

• Who is involved in the work?
• What can go wrong?
For a specific activity or procedure, identify the hazards in each step or task
that must be completed. Ask what, where, and how the work is occurring and
who is doing the work. Then, determine what could go wrong in every step of
the activity or procedure and the result of the undesirable incident (e.g.,
injury, exposure, infection, disease). One method of accomplishing this is to
perform a job hazard analysis.pdf iconexternal icon Examples are depicted
below.
 Top of Page

Step 2: Evaluate the risks

In this section, learn how to answer these questions:

• How likely is a risk and how severe is it?

• Is the risk acceptable or unacceptable?
a. Characterize the risks

There are various and multiple risks involved in performing laboratory

testing. The risk assessment should evaluate each risk against a standard set
of criteria so that the assessed risks can be compared against each other.
The criteria should focus on both the likelihood of the undesirable incidents
occurring and the consequences if those undesirable incidents were to
occur.

Source: Sandia National Laboratory Biosafety and Biosecurity Risk Assessment

Technical Guidance Document, 2014.
Likelihood and Consequences of Risk

The likelihood component of risk includes factors that affect whether or not
the incident happens and occurs before the actual incident occurs; the
consequences of risk considers factors that affect the severity of an incident
after it has occurred.

It is important to define what is being evaluated because some factors can

affect the likelihood and consequences. For example, the availability of
appropriate personal protective equipment (PPE) can reduce the likelihood of
exposure but wearing the appropriate PPE correctly can also reduce the
consequences if an exposure occurs.

Likelihood of Risk

Some factors to consider that can affect the likelihood of an undesirable

incident (such as exposure to a biological agent in this example) include:

• Biological agent factors

o Stability in the environment (e.g., ability to produce spores,
resistance to disinfectants)
o Potential routes of transmission (direct mucosal contact,
inhalation, ingestion, injection)
o Endemicity of biological agent in the local environment and
population (e.g., endemic or exotic) and host range
o Life stage/form of the biological agent (e.g., dimorphic fungi,
antigenic shift)
o Communicability
• Laboratory/testing environment factors
o Physical infrastructure and existing controls: the type of facility,
presence of engineering/safety controls, type of equipment used,
function/reliability of ventilation systems
o Procedural: existence of administrative controls such as policies
and training; availability of appropriate PPE; generation of
aerosols and use of sharps; amplification of the biological agent
by culturing, and the types and complexity of procedures being
conducted
 • Human factors
o Competency of personnel, level of training
o Behavioral aspects
▪ Stress, risk perception, risk tolerance
▪ Following safe work practices
To evaluate the consequences after an undesirable incident occurs, assess
the characteristics of the hazard(s) or biological agents, the health and
immune status of the laboratory/testing personnel, and the availability of
vaccines, prophylaxis, or therapies.

Consequences of Risk

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

incident (such as infection in this example) include:

• Biological agent factors

o Virulence factors: adhesion, invasiveness, toxigenesis, production
of exoenzymes, antigenic variation, resistance to antibiotics,
tissue tropism, multiple replication sites within-host, ability to
elicit autoantibodies against host)
o High communicability
o Severity of infection/disease (morbidity/mortality rate)
o Infectious dose
• Administrative controls
o Availability of vaccines, prophylaxis, therapeutic interventions,
and emergency response procedures
• Host factors
o Health and immune status of staff: immunocompetent or
immunocompromised, pregnancy, pre-existing medical
conditions, allergies, age, large susceptible population
o Behavioral aspects
▪ Willingness to accept vaccines
▪ Adherence to safe work practices and proper use of PPE
b. Prioritize the risks and determine if risks are acceptable

It is important to acknowledge that risks can be reduced, but generally

cannot be completely eliminated unless the work is discontinued entirely
(e.g., elimination) or modified to incorporate less harmful activities such as
using surrogates (e.g., substitution).

The risk assessment team should use the results to determine which risks
are relatively higher or lower than other risks. Based on the risk assessment,
the institution/testing site should determine which risks are acceptable (work
can proceed with the existing controls), and which risks are unacceptable
(work cannot proceed until additional mitigation controls are implemented to
reduce the risk to an acceptable level).

Top of Page

Steps 3-4: Implement a Risk Mitigation Plan

For risks that are determined unacceptable by the institution, a mitigation

control planexternal icon should be implemented.

Top of Page

Step 5: Evaluate Effectiveness of Controls

The effectiveness of implementing additional controls (e.g., engineering

controls, administrative and work practice controls, and use of PPE) should
be reviewed and evaluated.

For more information on mitigation and evaluation of the performance of

controls, see Biosafety in Microbiological and Biomedical Laboratories
(BMBL) (6th Edition)pdf icon.

Top of Page

Resources

• Biosafety in Microbiological and Biomedical Laboratories (BMBL) (6th

Edition)pdf icon
• Association of Public Health Laboratories (APHL) Risk Assessment Best
Practices and Examples (2016) pdf icon[PDF]external icon
• Introduction to Laboratory Risk Management (LRM)
• Guidelines for Safe Work Practices in Human and Animal Medical
Diagnostic Laboratories, MMWR 61(01)pdf icon
 • Public Health Agency of Canada Pathogen Safety Data Sheetsexternal
icon
• ABSA International Risk Group Databaseexternal icon
• WHO Laboratory Biosafety Manual, 4th Editionexternal icon
• ISO 35001 Laboratory biorisk management system for laboratories and
other related organizations;external icon note that users will have to
purchase the standard to view the full document
• CWA 15793 Laboratory biorisk managementpdf iconexternal icon
• CLIA Standards:
o Clinical Laboratory Improvement Amendments (42 USC 263a)pdf
iconexternal icon
o Standards and Certification: Laboratory Requirements (42 CFR
493)external icon
• Clinical and Laboratory Standards Institute (CLSI); note that users will
need a CLSI subscription to view these resources
o M29-A4 Protection of Laboratory Workers From Occupationally
Acquired Infections-4th Edition
o GP17-A3 Clinical Laboratory Safety-3rd Edition
o EP23 Laboratory Quality Control Based on Risk Management, 1st
Edition
• OSHA Job Hazard Analysispdf iconexternal icon
• OSHA Mitigation Planexternal icon
Contact Us

For more information about this Division of Laboratory Systems biorisk

assessment resource, contact us at [email protected].
Page last reviewed: October 21, 2021

Content source: Division of Laboratory Systems (DLS)

• Facebook

• Twitter

• LinkedIn
 Syndicate
•
homeBiosafety

• Initiatives
• Trainings
• Resourcesplus icon
o Biological Risk Assessment: General Considerations for
Laboratories
o ECHO (Extension for Community Healthcare Outcomes)
Biosafety Project
o Biosafety Town Hall
Related Links

• Division of Laboratory Systems (DLS)

• About CDC
• Contact Us
• 800-232-4636
FacebookTwitterInstagramLinkedInYoutubePinterestSnapchat

• U.S. Department of Health & Human Services

• Accessibility

• External Links

• Privacy

• Policies

• No Fear Act

• FOIA

• Nondiscrimination

• OIG

• Vulnerability Disclosure Policy

• USA.gov