Biorisk Management, Containment & Laboratory Safety

A comprehensive set of flashcards covering assessment, mitigation, performance, administrative controls, SOPs, containment levels, biosafety cabinets, PPE, decontamination, waste management, and transport regulations.

What are the three key components of Biorisk Management in the AMP model?

Assessment, Mitigation, and Performance.

What is the goal of Biorisk Assessment?

To identify hazards and evaluate the risks of biological agents and toxins, considering existing controls and deciding if the risks are acceptable.

Define Biorisk Mitigation.

Actions and control measures implemented to reduce or eliminate risks associated with biological agents and toxins.

In the AMP model, what does Performance involve?

Implementing, evaluating, and continually improving the entire biorisk management system to ensure it works as designed.

What is Residual Risk?

The level of risk remaining after mitigation measures have been applied.

Which hierarchy of controls is recommended for breaking the Chain of Infection?

Elimination/Substitution → Engineering Controls → Administrative Controls → PPE.

What are Administrative Controls in biosafety?

Written policies, rules, schedules, and training designed to lessen the duration, frequency, or severity of exposure to biohazards.

Give three examples of Administrative Controls.

Risk assessments, safety manuals & SOPs, and medical surveillance programs.

What is the purpose of a BioRisk Management Program?

To provide organizational structure, policies, and procedures that prevent occupational infections and environmental release of harmful organisms.

List four elements commonly found in a BioRisk Management Program.

Vision/Mission, Biosafety Policy, Training & Assistance, and Program Assessment.

Why is staff selection important in biorisk management?

To ensure personnel have suitable education, experience, and reliability for handling biological agents safely.

What does Medical Surveillance monitor in a lab setting?

The health of personnel in relation to occupational exposure to biohazards, including immunizations and post-exposure care.

Give two examples of Good Work Practices in a lab.

Strict aseptic technique and prohibiting eating, drinking, or smoking in the laboratory.

What is an SOP?

A Standard Operating Procedure—an instructional document that provides step-by-step directions to achieve a consistent outcome.

State the primary goal of an SOP as described by S.G. Kaufman.

Different people doing the same thing and obtaining the same result.

Name the four core components of an SOP.

Conditions, Context, Actions, and Documentation.

How can an SOP be tested for effectiveness?

Verify users understand it, can perform the steps, and consistently achieve the intended outcome.

What does BOD stand for and how is it used?

Behavioral Observation Data; yes/no questions on observed behaviors to validate and audit SOP compliance.

Provide two tips for writing clear SOP steps.

Begin each step with a single action verb and include quantitative information (e.g., 5 mL).

How often should SOPs be reviewed or revised?

Routinely—at least annually or whenever procedures, equipment, or regulations change.

Define Biocontainment.

Preventing the unintentional release of biological agents through a combination of primary and secondary barriers.

Differentiate primary and secondary barriers in containment.

Primary barriers (e.g., BSCs) contain the agent at its source; secondary barriers (e.g., room design, HVAC) contain it within the room or facility.

What biosafety level (BSL) requires controlled access and directional airflow?

BSL-3 laboratories.

List two engineering features typical of a BSL-4 facility.

Full-body positive-pressure suits with air supply and an isolated building with complete decontamination facilities.

Give three critical containment components for high-level labs.

HEPA filters, autoclaves, and inward directional airflow with door interlocks.

What is the difference between Commissioning and Certification of a lab?

Commissioning tests and documents performance of systems; Certification verifies commissioning success and ongoing compliance.

What does a Biosafety Cabinet (BSC) provide that a chemical fume hood does not?

HEPA-filtered exhaust for environmental protection and laminar airflow for product protection.

State the filtration efficiency of a standard HEPA filter.

99.97 % of airborne particles ≥ 0.3 µm.

What substances are NOT removed by HEPA filters?

Gases and vapors such as chemical fumes or radionuclides.

Name the three classes of BSCs.

Class I, Class II, and Class III.

What unique feature characterizes airflow in a Class II BSC?

A protective air curtain at the front with HEPA-filtered laminar downflow inside.

Where should a BSC be located in a laboratory?

Away from doors, windows, supply vents, and heavy personnel traffic to prevent airflow disruption.

Mention two safe practices while working inside a BSC.

Work from clean to dirty and minimize arm movement to maintain airflow integrity.

How does OSHA define Personal Protective Equipment (PPE)?

Specialized clothing or equipment worn by an employee for protection against infectious materials.

List three factors influencing PPE selection.

Type of anticipated exposure, task durability demands, and fit/comfort for the wearer.

Name four common types of PPE used in biosafety.

Gloves, gowns/aprons, goggles or face shields, and respiratory protection.

What is the primary purpose of an N95 respirator?

To protect the wearer from inhalation of infectious aerosols by filtering ≥ 95 % of particulates.

Why is annual respirator fit testing required?

To ensure there are no leaks around the face seal and the respirator offers the intended protection.

Define Sterilization in laboratory decontamination.

A physical or chemical process that destroys all microbial life, including bacterial spores (≥ 10⁶ kill).

Differentiate Decontamination, Disinfection, and Antisepsis.

Decontamination makes items safe for reuse/disposal; Disinfection selectively eliminates microbes; Antisepsis applies germicides to living tissue.

State four factors that affect disinfectant effectiveness.

Disinfectant concentration, microbial load/type, contact time, and environmental conditions (organic matter, temperature).

Which disinfectant concentration is generally recommended for vegetative bacteria?

2 % domestic bleach or 75 % ethanol.

Give the standard autoclave parameters for effective sterilization.

121 °C at 15 psi for at least 15 minutes (time adjusted to load size).

Name two items that should NOT be autoclaved.

Corrosive chemicals/solvents and radioactive materials.

How is autoclave performance routinely validated?

Using chemical indicators for every load and biological indicators (Geobacillus stearothermophilus spores) at least weekly.

Why is waste segregation important in biosafety?

It ensures each waste type receives the correct treatment and minimizes unnecessary handling of hazardous material.

How should RG-1 or RG-2 microbial solid waste be disposed of?

Collect in color-coded biohazard bags, autoclave, then place in black bags for general waste disposal.

What are the three layers of tertiary packaging for inter-facility transport?

Primary leak-proof container, secondary leak-proof container with absorbent, and durable outer packaging with labels.