Foundation Training in Biological Safety. Imperial College SafetyPage 2 Foundation training 4...

Foundation Training in Biological Safety

Imperial College Safety

Foundation training4 modules

1. Principles of biological safety

2. Hazardous chemicals within the biological lab

3. Gases and cryogenics

4. Working with Genetically Modified Organisms

Module 1Principles of biological safety


What are we trying to prevent?


Bl l


Laboratory-acquired infections at Imperial College

• Hepatitis A

• Vaccinia - 1991

• Vaccinia - 2000

• Meningococcal meningitis

Accidents do happen


Threat from

fatal bugs as

labs breach

safety rules(Observer)

College fined for exposing staff to lethal virus(The Times)

College exposed

workers to

death risk(Eastern Daily Press)

Top research institution fined for

‘serious’ safety offences(Yorkshire Post)


Safety training

Training

Sexy stuff

Time


Foundation training


Further training

• Training needs analysis– Identifies what training is required– Linked to work to be undertaken and the risk assessments

• Provision– Depends on what the training is

• DSOs• Group Leaders / Principal Investigators• Safety Department• CBS• etc

Compliance requirements


College policy

Legislation


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are needed to see this picture.


Lines of responsibility within Imperial College

Individuals

Principal Investigators

Heads of Sections/Groups

Heads of Divisions/ Departments/Institutions

Principal Officers

Rector

DSOs

FSOs

Safety dept

Support services


The Health and Safety at Work Act 1974

Primary legislation

The Control of Substances Hazardous to Health Regulations 2002 – general and biological agents provisions

Genetically Modified Organisms (Contained Use) Regulations 2000

Secondary legislation & approved Codes of Practice

The Management of Health and Safety Work Regulations 1999

The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995

The Anti-Terrorism Crime and Security Act 2000

The law


Health and Safety at Work etc Act 1974

• Key duties of the employer (Imperial College)- Ensure the Health and Safety of their employees- Ensure the Health and Safety of others

• Key duty of the employee (you)- Co-operate with the employer

The lawCOSHH

“hazardous substances”

• Chemicals (incl toxins)

• Carcinogens

• Biological agents


The lawCOSHH - general provisions

Reg. 6: Assess health risks

Reg. 7: Prevent or control exposure

Reg. 8: Use control measures

Reg. 9: Maintain, examine and test control measures

Reg. 10: Monitor exposure

Reg. 11: Health surveillance

Reg. 12: Information, instruction and training for persons who

may be exposed

Reg. 13: Arrangements to deal with accidents, incidents and

emergencies


The lawCOSHH - biological agents

Reg. 6: Assess health risks

Reg. 7: Prevent or control exposure

Reg. 8: Use control measures

Reg. 9: Maintain, examine and test control measures

Reg. 10: Monitor exposure

Reg. 11: Health surveillance

Reg. 12: Information, instruction and training for persons who

may be exposed

Reg. 13: Arrangements to deal with accidents, incidents and

emergencies

Schedule 3


All biological agents must be classified in one of four Hazard Groups

Increasing hazard to human health

The lawCOSHH

HazardGroup 1

HazardGroup 2

HazardGroup 3

HazardGroup 4


Group 1 - unlikely to cause human disease

The lawCOSHH

Definition of Hazard Groups

Group 2 - can cause human disease but is unlikely to spread to community and there is usually effective prophylaxis or treatment availableGroup 3 - causes severe human disease and may spread to community but there is usually effective prophylaxis or treatment available

Group 4 - causes severe human disease and may spread to community and there is usually no effective prophylaxis or treatment available


Available at

http://www.hse.gov.uk/pubns/misc208.pdf


Classification of biological agent USUALLY determines minimum containment level required

The lawCOSHH

HazardGroup 1

HazardGroup 2

HazardGroup 3

HazardGroup 4

ContainmentLevel 1

Containment Level 2

Containment Level 3

Containment Level 4


The lawCOSHH


But this is only the starting point …

The principles of;– Good Occupational Safety and Hygiene– Good Laboratory Practice– Good Microbiological Practice– COSHH

…..must all be applied when determining and applying a safe system of work

The lawCOSHH


Risk assessment process

Identify the hazard

Consider the nature of the work

Evaluate the risk

Consider the control measures required

Record and review the assessment

The way in which the agent can harm healthD

EF

INIT

ION

The likelihood and severity of harm

occurring

DE

FIN

ITIO

N


COSHH1st fundamental principle

COSHH requires that exposure is

prevented

1

controlled

2

If prevention not possible


How can exposure to an infectious agent be prevented?


Exposure to a particular biological agent is prevented by substitution with a less hazardous biological agent

Prevention of exposure by substitution

• Use lab adapted strains wherever possible

• Avoid clinical isolates wherever possible

• If the science will allow it, substitute with a less hazardous species e.g. M. tb with BCG

COSHH Reg 7


Prevention of exposure by segregation

• Prevent unnecessary and unauthorised access• Keep doors locked/ secure• Use appropriate signage (Biohazard)

If substitution is not possible then start by considering whether the work is adequately isolated from other staff, students, contractors or visitors

This will at least prevent exposure to those not doing the work


• Prevent unnecessary and unauthorised access• Keep doors locked/ secure• Use appropriate signage (Biohazard)• Permit-to-work systems





• Prevent unnecessary and unauthorised access• Keep doors locked/ secure• Use appropriate signage (Biohazard)• Permit-to-work systems• Write up areas in labs





COSHH2nd fundamental principle

If PREVENTION is not possible then CONTROL exposure

Work practicesEngineering controls

Suitable work equipment and materials

1

Control exposure at source

Use PPE2


Routes of laboratory infection

• Mouth– Eating, drinking and smoking in the laboratory– Mouth pipetting– Transfer of micro-organisms to mouth by contaminated fingers or articles

• Skin– Skin puncture by needle or other sharp– Bites and scratches by animals– Cuts, scratches

• Conjunctivae– Splashes of infectious material into the eye– Transfer to eye by contaminated fingers or articles

• Lungs– Inhalation of airbourne organisms


The work process and equipment

• What is the best way to do the research e.g. aerosol exposure of mice v. intranasal application

• Are you using/ making only what you need? (volumes/ titres/ concentrations)

• Can you change the work process/ technique so that even less is required?

• Are you using the right tool

Design and use appropriate work processes, systems and engineering controls and use suitable work equipment and materials


Sharps:Percutaneous exposure

One example of controlling exposure through appropriate work processes


Controlling the risks of percutaneous exposure by controlling the use of sharps

• Stop the unnecessary use of sharps, for example;– Tissue homogenisation with a sharp needle– Aliquoting of hazardous substance from septum

sealed vial– Use of glass pipettes for tissue culture


• Where sharps must be used;

– Ensure their proper use

– Ensure their proper disposal

– Ensure that there is an agreed needlestick response

– Ensure the risk assessment is carried out• Ensure that the policy on the use of sharps in any

particular lab is clear

Controlling the risks of percutaneous exposure by controlling the use of sharps


COSHH2nd fundamental principle

If PREVENTION is not possible then CONTROL exposure

Work practicesEngineering controls

Suitable work equipment and materials

1

Control exposure at source

Use PPE2


Aerosols / dropletsSplashes and inhalation

One example of controlling exposure at source using engineered control measures


Secondary control measure

Primarycontrol measure

the worker


Microbiological safety cabinets

• Required for work at CL2 and 3 if the work presents a risk of aerosol exposure

• Must be correctly selected (type and make)

• Must be correctly installed

• Must be correctly used

• Must be correctly maintained


USER

HEPA filter

Class I cabinet


Class II cabinet

USER

Exhaust HEPA filter

DownflowHEPA filter


Class III cabinet

USER

HEPA filter

HEPA filter


MSC

1000 mm

Keep pedestrian traffic away from the front of the MSC

MSC

300 mm

Keep clear of adjacent wall

MSC

Keep clear of door openings

MSC

1500 mm

Position clear of bench opposite

benc

h

MSC

2000 mm

Position well clear of wall opposite

Do not have another worker at an adjacent bench

MSC

bench

MSC

Allow adequate room for workers at nearby benches

bench

300 mm

MSC

3000 mm

Keep well clear of safety cabinet opposite

MSC

Siting


Siting

Do not have another worker at an adjacent bench

MSC

bench

MSC

Allow adequate room for workers at nearby benches

bench

300 mm

Siting


What can a Class II MSC be used for?

• Changing the media on TB infected cells?

• Homogenising human tissues

• Chloroform / methanol extractions of bacterial suspension

• Aliquoting of 20 ml methanol from a 2.5 litre winchester bottle


What’s the difference between a fume cupboard and an MSC?

• MSC is HEPA filtered• Fume cupboard has usually no filter

• MSC may not be spark proof• Fume cupboard is

• Class II MSC recirculates 70% of the air within the work space

• Fume cupboard is 100% extract


Advantages and limitations of safety cabinets

• Vaccinia incident

• What if this has happened outside of the cabinet?

• Limitations of open fronted cabinets


Proper use: before you start work

• Plan your work thoroughly• Put on appropriate PPE• Switch on cabinet and remove night door• Ensure that cabinet is running correctly – gauge must be in SAFE zone• Ensure that cabinet is clean and free of clutter• Prepare thoroughly for work. Plastics, reagents, samples must be at

hand• Have appropriate disinfectant(s) at hand• Place work in the cabinet, ensuring that clean and dirty materials are

kept separate


Proper use: whilst at the cabinet

• Do not overcrowd the cabinet• Work only within the constraints placed upon the use of the cabinet e.g.

microfuges• Know the limitations of the protection afforded by open-fronted cabinets• Regularly check that the airflow gauges are in the SAFE zone• (For open-fronted cabinets) always work towards the rear of the cabinet• (For Class II cabinets) do NOT obstruct the airflow grilles at the front or

back of the cabinet• Keep other workers out of your non-disturbance zone• Do not mix sterile and infected materials• Do NOT use a cabinet if its safe operation is in doubt


Proper use: after completion of the work

• Check that the airflow gauges are in the SAFE zone• Remove samples for incubation, etc after wiping down flasks, etc with

appropriate disinfectant• Only remove contaminated materials from the cabinet as directed by

your Code of Practice• Remove all your equipment and waste• Wipe all surfaces with disinfectant or fumigate, as appropriate. Use

disinfectants in a manner that will not affect the cabinet.• (For Class II cabinets) clean thoroughly under the grilles• Switch off cabinet and replace night door where local procedures direct


Training and competence

• No person should be allowed to work at an MSC unless proper training has been given and the person is competent to do the work

• Such training should include– Classification of cabinets– Appropriate and inappropriate use of cabinets– Mode of operation and function of all controls and indicators– Limitations of performance– How to work safely at the cabinet– How to decontaminate after use– Principles of airflow and operator protection tests

Human blood and tissues


Universal precautions

• All blood and certain other materials must be considered infected, unless known to be otherwise

• Main infection hazard is HIV, HepB,and HepC


In the context of universal precautions what is meant by ‘known not to be infected’?

• You are asked to handle blood taken from all three of these donors

• Which can you consider to be safe?

Workshop exercise


Answer

• None of them

• They must all be handled the same without other evidence

• Don’t judge a book by its cover (or the person next to you by the clothes they wear)


Routes of transmission

• Percutaneous transmission refers to any transmission by penetration of the skin with needles and other sharps.

• Mucocutaneous transmission occurs through broken or apparently intact skin or through the mucous membranes of the eyes, nose or mouth.


What are Universal Precautions

• Transport samples in robust containers. Use secondary containment.

• Wear gloves when handling blood• Use a safety cabinet if generating aerosols or splashes• Do not mouth pipette• Minimise use of sharps• If sharps are required - use them properly• Dispose of waste appropriately• Know what to do in the event of an exposure• Get HepB vaccination


Other potentially infectious material

• Any body fluid containing visible blood

• Semen

• Vaginal secretions

• Cerebrospinal fluid

• Synovial fluid

• Pleural fluid

• Peritoneal fluid

• Pericardial fluid

• Amniotic fluid

College procedures


College procedures

• Pro-forma risk assessments available on Spectrum– DP1 – Deliberate work– DP2 – Unintentional work


PI submits final draft to Occupational Physician (OP)Contact Alan Swann [email protected]

College BSO reviewsContact Anton de Paiva [email protected]

PI incorporates DSO, BSO and CBS DSO’s comments into risk assessment

If OP recommends specific action e.g. entry health screen/ health surveillance/ vaccination no approval for work to start

until all involved have enrolled with OH for the service. The PImust then ensure that any new staff joining after approvals

have been granted, are also enrolled with OH before commencing work

If Containment Level 2 or 3DSO submits proposal along

with a copy of the Code of Practice to College BSO. The

need to notify the HSE is identified and discussed with the

College BSO

DSO reviews

Principal Investigator (PI) or their delegate undertakes the risk assessment

Approvals process for new activities or significant changes to existing activities involving the deliberate use of biological agentsSeptember 2005

If Containment Level 1PI incorporates DSOs comments into the risk

assessment, implements all required control

measures and issues risk assessment to all affected

persons BEFORE commencing the work

WORK CAN COMMENCE

WORK MUST NOT COMMENCE untilwritten approval has been provided by the HSE

PI forwards signed copy of approved risk assessment along with completed CBA1 form to College BSO

PIs MUST NOT SUBMIT THIS FORM TO THE HSE

If work DOES require notification to the HSE

College BSOsubmits notification paperwork to HSE

HSE reply in writing within 20 days

College BSO informs PI and DSO

WORK CAN COMMENCE

NOTE: HSE notification is required for some new work with Hazard Group 2 agents and all new work with those in COSHH Schedule 3, Part V. Also, any significant changes to work with Corynebacterium diphtheria, Neisseria meningitidis, Bordetella pertussis and all Hazard Group 3 agents require notification. The relevant form CBA1 is available at https://www.hse.gov.uk/forms/notification/cba1.pdf

Occupational Physician, College BSO and DSO recommend project for approval pending any required HSE notification

CBS DSO reviews if proposal

involves use of animals

Subject to localarrangements

Local Safety Committee reviews and recommends Head of Dept./ Div. approves work

Head of Dept/. Division (or their designate) signs off project

NOTE: Risk assessment pro-forma for work with biological agents is available on the Health and Safety pages of Spectrum. Advice on preparing the risk assessment can be obtained from the Departmental BSO(s), DSO or College BSO.

If work does NOT require notification to the HSE PI issues risk

assessment to all relevant staff and

students

PI submits final draft to Occupational Physician (OP)Contact Alan Swann [email protected]

College BSO reviewsContact Anton de Paiva [email protected]

PI incorporates DSO, BSO and CBS DSO’s comments into risk assessment

If OP recommends specific action e.g. entry health screen/ health surveillance/ vaccination no approval for work to start

until all involved have enrolled with OH for the service. The PImust then ensure that any new staff joining after approvals

have been granted, are also enrolled with OH before commencing work

If Containment Level 2 or 3DSO submits proposal along

with a copy of the Code of Practice to College BSO. The

need to notify the HSE is identified and discussed with the

College BSO

DSO reviews

Principal Investigator (PI) or their delegate undertakes the risk assessment

Approvals process for new activities or significant changes to existing activities involving the deliberate use of biological agentsSeptember 2005

If Containment Level 1PI incorporates DSOs comments into the risk

assessment, implements all required control

measures and issues risk assessment to all affected

persons BEFORE commencing the work

WORK CAN COMMENCE

WORK MUST NOT COMMENCE untilwritten approval has been provided by the HSE

PI forwards signed copy of approved risk assessment along with completed CBA1 form to College BSO

PIs MUST NOT SUBMIT THIS FORM TO THE HSE

If work DOES require notification to the HSE

College BSOsubmits notification paperwork to HSE

HSE reply in writing within 20 days

College BSO informs PI and DSO

WORK CAN COMMENCE

NOTE: HSE notification is required for some new work with Hazard Group 2 agents and all new work with those in COSHH Schedule 3, Part V. Also, any significant changes to work with Corynebacterium diphtheria, Neisseria meningitidis, Bordetella pertussis and all Hazard Group 3 agents require notification. The relevant form CBA1 is available at https://www.hse.gov.uk/forms/notification/cba1.pdf

Occupational Physician, College BSO and DSO recommend project for approval pending any required HSE notification

CBS DSO reviews if proposal

involves use of animals

Subject to localarrangements

Local Safety Committee reviews and recommends Head of Dept./ Div. approves work

Head of Dept/. Division (or their designate) signs off project

NOTE: Risk assessment pro-forma for work with biological agents is available on the Health and Safety pages of Spectrum. Advice on preparing the risk assessment can be obtained from the Departmental BSO(s), DSO or College BSO.

If work does NOT require notification to the HSE PI issues risk

assessment to all relevant staff and

students

Guidance


The Health and Safety at Work Act 1974Primary legislation

The Control of Substances Hazardous to Health Regulations 2002 – general and biological agents provisions

Genetically Modified Organisms (Contained Use) Regulations 2000

Secondary legislation & approved Codes of Practice

Biological agents: Managing the risks Infection risks to new and expectant mothers in the workplace

A guide to the Regulations

Biotechnology: Health and Safety in education

Management, design and operation of microbiological containment laboratories

Research animals, including simians

Large-scale contained use of biological agents

General guidance

Clinical laboratories

Disposal of clinical waste

Blood borne viruses

Transmissible spongiform encephalo-pathies

Viral haemorrhagic fevers

Guidance on containment and control measures

Guidance on work with specific agents

ACGM Compendium of guidance

Foundation Training in Biological Safety. Imperial College SafetyPage 2 Foundation training 4...

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