Biorisk Management = Assessment, Mitigation, Performance

Dr: Dina RamadanMicrobiologist Quality manager ,central health laboratory

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Biorisk Mitigation

Lab and

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Engineering Controls

Administrative Controls

Practices and Procedures

Personal Protective

Equipment (PPE)

Mitigation Control Measures

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Mitigation Control Measures

1. Engineering Controls: Physical changes to work stations, equipment,

materials, production facilities, of the work environment that reduce or prevent exposure to hazards

I Lab design

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II SAFETY EQUIPMENT1. Hoods

Fume HoodsFume hoods are used when chemical reagents may produce a

hazardous fume.Air flow should be checked to assure proper ventilation.

Biological Hoods

Biological safety cabinets (BSCs) it remove particles that may infect the person working

with the biologically infected specimen. These hoods contain a HEPA (high-efficiency particulate

air) filter

2 Chemical storage equipment Safety cabinets are required for the storage of

flammable liquids

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Con/ Mitigation Control Measures

2. Administrative Controls: Policies, standards , and guidelines used to control

risks

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• Policies and risk management plan• Records for accidents• laboratory Signs• training

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Con /Mitigation Control Measures3. Practices and Procedures: Processes and activities that have been shown in practice to be effective in reducing

risks

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Con/ Mitigation Control Measures

4. Personal Protective Equipment: Devices worn by the worker to protect against hazards

in the laboratory

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Advantages/Disadvantages

Control Measure Advantages Disadvantages

Engineering Efficient,eliminates hazard

Cost,complexity

Administrative Authority approach Indirect approach, primarily addresses the human factor

Practices & Procedures SOP based (standardized approach)

Training and supervision requirements

PPE Ease of use, relative cost Does not eliminate hazard, PPE fails exposure happens, uncomfortable, limits ability

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wwww

Motorcycle safety is all about PPEWhat is more safe?

Car vs. Motorcycle SafetyCar safety is all about engineering systems

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Elimination not doing the intended Work or Substitution using different materialsNotes : Control methods at the top of the list are in general more effective and protective than those at the bottom.

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•first you must consider elimination or substitution•A combination of control measures should be used based on their effectiveness and your ability to implement them

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Biorisk managment

Biosafety Risk Assessment

Biosecurity Risk Assessment

Biosafety Risk Mitigation

Biosecurity Risk Mitigation

Identification of Biorisks

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Assessment , Mitigation, Performance

•Risk identification•Hazard/threat identification•Likelihood evaluation•Consequences evaluation

Biorisk Management

•Elimination or Substitution•Engineering Controls•Administrative Control•Practices and Procedures•Personal Protective Equipment

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what specific steps are still missing from the system after assessment and

mitigation?

performance

Performance is the way in which someone or something functions

Performance improves biorisk management

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How performance improve risk management system

It give idea of the following: If your system work will ( control) If your system sustainable (assure) If the risk is accessible (improve)

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Performance

• Control – Policy– Procedure– Structure– Responsibility

• Assurance checking the system through audits and inspections• ImprovementSetting and achieving management goals based on internal and

external feedback.

• The Trilogy of Quality Management

Juran (1904-2008)

• Quality Planning

• Quality Control

• Quality Improvement

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ControlIt is the procedures undertaken by the laboratory staff for

theCONTINUOUS AND IMMEDIATE

monitoring of laboratory work in order to decide whether the results are reliable enough to be released.

Through :

Validation/verification,

quality control,

proficiency testing,

specimen management

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Control

Policies

Procedure

Structure

Responsibility

“what to do”

“how to do it” (SOPs)

“Organization structure”

“Who do what”

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Assurance checking the system through audits and inspections

Includes IQC, EQA, pre-analytic phase, test standardization, post-analytic phase, Performance Evaluations management, and organization (WHO, 1992)

Internal audit or self

evaluation

External evaluation

Improvementmeasures

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Improvement

Setting and achieving management goals based on internal and external feedback.

On-going process

Improvementmeasures

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Continuous improvement philosophyPDCA: Plan-do-check-act as defined by Deming.

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AMP vs. PDCAAssessment = Plan, Do, Check, Act

Mitigation = Plan, Do, Check, Act

Performance = Plan, Do, Check, Act

AMP

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Risk Management Process

Risk Assessment

Risk Mitigation performance

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Biosafety Risk Assessment

Biosecurity Risk Assessment

Biosafety Risk Mitigation

Biosecurity Risk Mitigation

Performance Measures

Identification of Biorisks

BIORISK MANAGEMENT

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The AMP Model

Biorisk Management Assessment Mitigation Performance

Risk/Hazard/threat identification

Risk Assessment Biorisk Control Measures

Risk ManagementProcesses

QA/QCObjectives

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What happens if you focus all your energy on one component?

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The system starts to fall apartQUICKLY

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