Biorisk management Flashcards
most important factor at the origin of accidents
human error
have been used, even in the recent past, to threaten and harm people, to disrupt society, economies and the political status quo
Toxins and pathogens
Situations that urged the need to respond to the international community and articulate biosecurity in the laboratory:
Smallpox
Poliomyelitis
Anthrax
Current trend for biorisk management is:
Rather than providing a prescriptive approach to addressing biosafety and
related issues, and requesting compliance with a set of strict rules, the move to a goal-setting approach describing performance expectations for facilities and placing the responsibility on single facilities to demonstrate that appropriate and valid biorisk minimization measures have been established, is
proving very successful.
Agents that pose a risk to the well-being of a person, medically speaking, by directly causing an infection to the man’s systems or by disrupting the environment he/she is functioning in.
Biohazard
Commonalities and conflicts of laboratory biosafety and biosecurity
Keeping VBM safely and securely inside the areas where they are used and stored;
Controls that reduce unauthorized
access might also hinder an emergency response by fire or rescue personnel.
Biohazard signs placed on laboratory doors
• Possibility that something bad or unpleasant (such as an injury or loss) will happen
• Likelihood that an adverse event involving a specific hazard or threat will occur and
the consequences of that occurrence.
• Is always dependent on a situation
Risk
something that has the potential to cause harm
Hazard
Risk assessment goal
Understand the risk
Determine the risk
Define strategic mitigation of risk
All of these risks involving biological agents
Biorisk
Can affect humans, animals, or the environment after an accidental exposure or release of a biological agent.
Biosafety risk
Factors contributing to the severity of risk in biosafety risk
o Properties of the VBM
o Properties of the potential host.
o Work practices and procedures.
• Results from a person who has malicious intent and has potential access to a
hazardous material or facility.
• Dependent upon intent of the individuals and their level of determination to obtain
or use the asset
Biosecurity risk
substantive exercises that evaluate all of a facility’s
risks, and are based on the unique operations of the facility, not on generic
agent risk statements or agent risk groups.
Risk assessment
Risk assessment should be based on 3 general question
Define the situation
Define risk in the situation
Characterize the risk
Responsibilities of RA
- biorisk management advisors/ biosafety professionals
- principal investigators, scientist, researchers
- security and response personnel
- Legal department
- Laboratory contractors
- Executive management
- Administration
- Community stakeholders
⇒ implemented according to management’s risk-based decisions, not based on a predetermined description of a biosafety level.
⇒ Most common management approach to achieve safety and security.
Mitigation
5 Areas of Controls in mitigatio
Elimination/substitution Engineering controls Administrative controls Practices and procedures PPE
highest degree of risk reduction
Elimination
when elimination isn’t possible
Substitution
Physical changes to work stations, equipment, production facilities, or any other relevant aspect of the work environment that reduces or prevents exposure to hazards
provide example
Engineering controls
Policies, standards, and guidelines used to control risks.
Administrative control
devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the laboratory
PPE
study and use of theory and methods for the analysis of data arising from random processes or phenomena
Statistics
The study of how we make sense of data
Statistics
Two Main Fields of Statistics
Mathematical and applied statistics
study and development of statistical theory and methods in the abstract
Mathematical stats
the application of statistical methods to solve real problems involving arandomly generated data and the development of new statistical methodology
motivated by real problems
Applied stats
Is the branch of applied statistics directed toward applications in the health sciences and biology
Biostatics
Other branches of applied statistics
Psychometrics Econometrics Chemometrics Astrostatistics Envirometrics
provide statistical methods that are more heavily used in health application than elsewhere (e.g., survival analysis, longitudinal data analysis.)
Biostatics
e starting point of a clinical study.
Hypothesis
a statement that describes the relationship between two or more variables and can be proven or disproven by supporting data.
Hypothesis
Characteristics of a good hypothesis include
Simplicity Clarity Impartiality Specificity Objectively Relevance Verifiability
Types of Hypothesis
Null and Alternative hypothesis
would predict the direction of the effect
one-tailed alternative hypothesis
there is an association without specifying the direction
A two-tailed alternative hypothesis
observations of random variables made on the elements of a population or sample
Data
the quantities (numbers) or qualities (attributes) measured or observed that are to be collected and/or analyzed
Data
The word data is plural - __ is singular
datum
