PMLS MT 101 - Biorisk Management (LESSON 7)

Laboratory Biosafety

The containment principles, technologies, and practices implemented to prevent unintentional exposure to pathogens and toxins, or their unintentional release

Protecting people from dangerous pathogens

Laboratory Biosecurity

Institutional and personal security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens and toxins

Protecting people from dangerous people

Severe Acute Respiratory Syndrome (SARS) 2003

Infected over 8,000 people and killed almost 800

Laboratory acquired SARS outbreak

Severe Acute Respiratory Syndrome (SARS) 2003

How did biorisk start?

Singapore - September 2003

Taiwan - December 2004

Mainland China - March 2004

Enumerate the affected countries of SARS

Singapore

A male graduate student in Environmental Science working in a BSL-3 laboratory performed inappropriate laboratory procedures, resulting in cross-contamination involving SARS-CoV.

Taiwan

A male laboratory scientist at a BSL-4 laboratory at the Institute of Preventive Medicine, National Defense Medical Center, was working with SARS-CoV when he discovered a material spill, which he disinfected with 70% ethanol before manually cleaning it up.

China

Female research student Failed or incomplete inactivation of SARS-CoV

Roles of Managers in BRM

- Conducts judicious evaluation of risk, selecting which mitigation measures will be employed

- Arrives at a decision

- Influences to Management Decision

Biorisk Management and the AMP Model Biorisk

Biological toxins or infectious agents

Unintentional exposure to unauthorized access, accidental release or loss, theft, misuse, diversion, or intentional unauthorized release of biohazards

Birorisk Management

The integration of biosafety and biosecurity to manage risk when working with biological toxins and infectious agents.

Biorisk Management

A system or process to control safety and security risk associated with the handling or storage and disposal or biological agents and toxins in laboratories and facilities (CWA)

Biorisk Management

Encompasses the identification, understanding, and management aspects of a system in an interrelated process.

Assessment, Mitigation, Performance

Enumerate the three components of the AMP model

Assessment

Process of identifying hazards and evaluating the risk associated with biological agent and toxins

Mitigation

Actions and control measure that are put into place to reduce or eliminate the risk associated to biological agents or toxins

Performance

Improving biorisk management through recording, measuring, and evaluating, organizational actions and outcomes to reduce biorisk

AMP Model

requires control measures be based on a robust risk assessment, and a continuous evaluation of effective and suitability of the control measures.

Hazard

object that can cause harm

Threat

person who has intent and/or ability to cause harm to other people, animals, or the institution

LIkelihood

probability an event occurring

Risk

likelihood of an event/incident with hazard that has consequences

Consequences

severity of an event/result

Risk

- Refers to a situation which is exposed to harm, danger, or loss

- Potential of harm

- Probability

- It can be expressed in degrees

Hazard

- Defines as something that can cause harm, loss or danger

- Potential source of harm

- Physical object, situation, or setting

- It cannot be expressed in degrees

Laboratory Risk Assessment

An analytical procedure designed to characterize and evaluate safety and security risk in a laboratory

Define the Situation, Define the Risk, Characterize the Risk, Determine if the risk is acceptable or not

Enuemrate the Process of Risk Assessment

Define the Situation

Identify the hazards and risk , the at-risk host inside and outside the laboratory, work activities, procedures and equipment, and lab environment

Define the risk

Review how individuals inside and outside the laboratory maybe exposed to the identified hazard

Characterize the Risk

compare the likelihood and the consequences of infection

Determine if the risk is acceptable or not

The process of evaluating the biorisk arising from a biohazard

i. Adequacy of any existing controls

ii. Deciding whether or not the biorisk is acceptable

Rare - 1

May occur only in exceptional circumstances

Unlikely - 2

Could occur at some point

Possible - 3

Might occur at some point

LIkely - 4

Will probably occur in most circumstances

Almost Certain - 5

Expected to occur in most circumstances

Insignificant - 1

No injuries, low financial loss

Minor - 2

First aid treatment, on site release, immediately contained

Moderate - 3

Medical treatment required, high financial loss

Major - 4

Extensive injuries, loss of production, major financial loss

Catastrophic - 5

Death, toxic release off site with detrimental effect, huge financial loss

Mitigation

The second fundamental component of the biorisk management model

Biorisk Mitigation Measurement

The action and control measures are put into place to reduce or eliminate the risk associated with biological agents and toxins.

Elimination

Physically remove the hazard

Substitution

Substitution of a serious pathogen with one that is much less pathogenic

Isolation

Isolate people from the hazard

Engineering Controls

Physical changes to work stations, equipment, materials, production, facilities, or any other relevant aspect of the work environment that reduce or prevent exposure to hazard

Adminstrative

Policies, standards and guidelines

Practices and Procedures

Process and activities

PPE

Devices worn by the worker to protect against hazards

The last pillar of the biorisk management model

Performance Evaluation

- A systematic process intended to achieve organizational objectives and goals

- Ensures that the implemented mitigation measures are indeed reducing or elimination risk - Can be eliminated or replaced

Performance Management

A reevaluation of the overall mitigation strategy