LABORATORY

SAFETY

MANUAL

School of Medicine (Hartshill Campus/Guy Hilton Research centre)

Keele University

(Updated December 2011)

Contains information supplementary to the Keele Staff Health & Safety Handbook and the

ISTM “Procedures & Guidelines” handbook.

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CONTENTS

Title Page N°. Responsibilities for Safety in ISTM 3

Membership of Safety Committees 4 Staff Induction Procedures 5

Occupational Health Services 6

Medical emergencies:

• First Aid-general 6

• Liquid nitrogen burn 7

• Needle stick 8

Non-medical emergencies:

• Gas leaks 8

• Major Spillages-see laboratory safety procedures

Laboratory Safety Procedures

• Rules for Laboratory Staff 9

• Personal Protective Equipment 10

• Spillages 11

• Fume Hoods 13

• Gas Cylinders 14

• Electrical Equipment 14

• Centrifuges 15

• Use of Glutaraldehyde 16

• Lasers 16

• Radiation 17

Procedures for Implementation of COSHH 18

• Risk Assessment Procedures 20

Procedures for working with human tissues 25

General guidelines 25

Acquiring Human Samples 28

Handling Human Tissue Samples 29

Personal Protective Equipment 31

Environmental contamination control 32

Record Keeping 35

Packaging and transporting Human Tissue Samples 36

Disposal of Human Tissue Samples 37

Accident Reporting 40

Procedures for working with Genetically Modified Organisms 41

General Rules 42

Waste Disposal Spillages 43

Acquisition and Storage of GMOs 44

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Responsibilities for Safety in the ISTM

Vice Chancellor/Registrar/University Safety Committees & OHSU

Departmental

Safety

Adviser Head of ISTM

(DSA)

Chair of ISTM of Safety Committee

Supervisors

Individual Researchers

The above management hierarchy describes how safety policy is managed at the Hartshill Campus

site.

Currently the Head of ISTM is professor Gordon Ferns

The Chair of the Safety Committee in Hartshill Campus site is Dr Ying Yang

The DSA is Dr Ying Yang

The Deputy DSA is Mrs Julia Magnay.

The GMO adviser is Dr Alan Richardson

The COSHH officer is Dr Ying Yang

The biological adviser is Dr Nick Forsyth

The radiation adviser is Dr Ying Yang

The laser adviser is Dr Ying Yang

Abbreviations

GMO - Genetically Modified Organism

COSHH - Control Of Substances Hazardous to Health

DSA - Departmental Safety Adviser

OHSU - Occupational Health & Safety Unit (Keele)

Reporting

Committees

GMO

COSHH

Radiation

Laser

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Membership of Safety Committees

ISTM Safety Committee (Hartshill Campus site)

Dr Ying Yang

Mrs Julia Magnay

Dr Nick Forsyth (Biological adviser)

Dr Alan Richardson (Chair of GMO Committee)

Mrs Jeanette Forester (Department senior fire steward)

Mr Ian Williamson (Head of University OHSU)

Miss Beryl Alcock (R & D section)

GMO Sub-Committee

Dr Alan Richardson Chair

Dr Nick Forsyth

Dr Ying Yang

Abbreviations

DSA - Departmental Safety Adviser

OHSU - Occupational Health & Safety Unit (Keele)

OHD - Occupational Health Department (Trust)

GMO - Genetically Modified Organism

COSHH - Control Of Substances Hazardous to Health

GMOBSO - Genetically Modified Organisms Biological Safety Officer

RPO - Radiation protection Officer

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PROCEDURES FOR LABORATORY STAFF INDUCTION

As a part of the induction of new employees, the ISTM administrator will introduce this Health &

Safety manual, issue your personal Staff Health & Safety Handbook and highlight the more

important rules. Every new staff should be required to sign a cover note stating that they have read

the contents.

As part of the induction process new employees MUST complete forms for:

• Departmental Induction Checklist

• Workplace Hazard Identification

The induction checklist ensures that you are familiar with the working environment and the

hazard identification form will highlight any work activities that could require additional

training or health monitoring to be initiated. These will be issued by the ISTM

administrator and introduced by them on your first day.

A copy of these forms may be obtained from the School administrator.

A copy of the completed induction checklist will be put in the individual’s personal file and the

hazard identification form will be sent to the OHSU.

Research assistants/technicians/students

No work should commence until your designated supervisor is satisfied that you have read and

understood the basic health & safety issues described in this manual and the Staff Handbook.

Laboratory activities should be conducted under close supervision of trained personnel until you

are able to receive training in relation to COSHH, human tissues, GMO, laser, radiation, where

applicable. Formal training will be provided in all these areas and MUST be arranged through your

supervisor or departmental safety adviser, as soon as possible after you start.

Research Fellows/post-docs A basic level of knowledge of Health & Safety issues and specific knowledge of COSHH, human

tissues, GMO, laser and radiation regulations is expected, dependent on the level of experience and

area of expertise. Deficiencies should be discussed with designated supervisors/senior staff and

addressed by training as required. Undoubtedly, “local” procedures will need to be highlighted and

understood before commencing any activities.

Lecturers/Professors

Staff should identify any deficiencies in their training and arrange to attend the appropriate

training sessions as soon as possible after commencing work. They should consult with

experienced colleagues or corresponding DSA about local issues and procedures that apply to their

activities.

Visiting Staff

It is the responsibility of the person making the invitation to ascertain whether the visitor will

require specific training and arrange it accordingly. For short visits formal training may be

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impractical and therefore arrangements should be made for close supervision and/or individualised

training to be given.

OCCUPATIONAL HEALTH SERVICES

Health surveillance is provided by the OHSU for University staff and students and by the

Occupational Health Department for Trust employees.

Depending on the nature of the work being undertaken surveillance or monitoring may be

necessary, as determined from an appropriate risk assessment or from the Workplace Hazard

Identification form completed on induction.

FIRST AID

Qualified first aider: Mrs Heather Reidy and Mrs Anne Harrison (Dr Darren Clements, trained in CPR)

Four First aid boxed have been located in the reception; Keele lab. corridor; the kitchen and MRU lab.

corridor.

The following general principles should be observed in the case of serious or potentially serious

accidents.

EYE ACCIDENTS In the case of eye injury where splashes of chemicals have entered the eye, commence irrigation

with clean water immediately. Eye wash facilities are available in the corridors of Keele lab.,

MRU lab. and the Molecular lab. (2nd

floor). Do not attempt to touch the eye or remove particulate

matter, this requires expert medical attention. Continue the irrigation until certain that all traces of

chemical are removed. Seek medical help in all cases of eye injury.

GAS ACCIDENTS If a person has been gassed, removal to an area where uncontaminated air is available is essential.

Loosen clothing around the neck and waist and keep the patient warm. If breathing has ceased,

artificial respiration should be started immediately.

COSHH

Refer to the appropriate risk assessments for specific advice related to accidents with hazardous

substances.

STAFF HEALTH All staff will be informed at induction about their employer’s Occupational Health Department

(Keele and Trust). New members of staff will be interviewed and any necessary arrangements

made for immunisations and investigations.

PREGNANCY

Female members of staff dealing with specified potentially infective agents or materials, any

radioactivity or certain chemicals should appreciate that exposure during pregnancy to any of a

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range of known substances carries a possible hazard for the foetus. Exposure during very early

pregnancy may be of special importance. It is advisable that female staff should advise the DSO or

relevant OHD (Trust or Keele) if they intend to become pregnant or are pregnant, so that risks of

their employment may be reviewed. In some cases, serological tests may be available to determine

a member of staffs immunity against an organism at the start of employment and later if necessary.

Work with certain infective agents (e.g. L.monocytogenes) or known mutagenic or teratogenic

chemicals (e.g. sodium hydrogen selenite) must be positively discouraged during pregnancy.

Radiation exposure limits are much lower for pregnant women, so no radiation work can be

undertaken by women who are trying to become, or who are pregnant.

LIQUID NITROGEN - SAFETY ADVICE - TREATMENT

1. When transferring liquid nitrogen from one vessel to another, non-absorbent leather gloves

should be worn together with a full face protection shield.

2. Any vessel used for containing liquid nitrogen must be of double wall ‘Dewar’ construction

suitably labelled and vented.

FIRST-AID TREATMENT FOR LIQUID NITROGEN CONTAMINATION/INJURY

The aim of treatment is to raise the temperature of the affected part SLOWLY back to normal.

Minor Injuries

1. Move victim to comfortable room if possible.

2. Ensure that clothing about the part is loose to provide unrestricted circulation. Do not remove

adherent clothing until thawed thoroughly.

3. Place affected part in TEPID WATER or flow TEPID WATER over part for half an hour until

skin changes from pale yellow through blue to pink or red. Do not use hot water or any other

form of direct heat.

4. Cover affected part with bulky dry sterile dressing.

5. Send victim to hospital casualty department.

Major Injuries

1. Send for ambulance.

2. Follow minor injury procedure as much as possible.

NEVER GIVE ALCOHOL OR ALLOW SMOKING

3. Remove any clothing that may restrict circulation to the affected area. Remove patient to

medical centre or hospital as soon as possible.

4. Immediately place the part of the body exposed to the cold temperature in a water bath with a

temperature of, ideally not less that 40°C (104°F) but certainly not more than 42°C (108°F).

Note : Never use hot water or dry heat.

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Note: Temperatures in excess of 45°C will superimpose a burn on the frozen tissue

5. If there has been extensive body exposure to cryogenic temperatures such that the general body

temperature is depressed the patient must be rewarmed without delay. The patient should be

placed in a bath of warm water at a temperature between 40-42°C (104-108°F). It is important

that the temperature of the bath is maintained at a level of not less than 40°C to maximise the

rate of rewarming.

6. In the absence of facilities for this treatment the patient should be taken to a warm atmosphere.

Preferably at a temperature of 22°C. Keep at rest and lightly covered with one or two blankets

until recovery is completed.

7. Shock may occur during the rewarming process.

8. Frozen tissues are often painless and appear waxy with a palish colour. Thawing after disruptive

deep burns results in vasodilation, increased capillary permeability and oedema. The tissues

become painful, swollen and prone to infection when thawed. Thawing may take from 15-60

minutes and should be continued until the pale colour of the skin turns to pink or red. The

thawing process may require major analgesia. Symptomatic treatment and the prevention of

infection is indicated.

9. If the frozen part of the body is thawed by the time medical attention has been obtained, do not

rewarm. Cover the area with dry sterile dressing with a large bulky protective covering.

NEEDLE STICK In the case of needle stick or any puncture wound which have contaminated human tissue or blood

must be treated immediately by encouraging bleeding and liberally washing with soap and water.

Puncture wounds or contamination of mucous membranes or broken skin must be reported

promptly to the Head of Department, DSA, Senior Laboratory Staff and Dr Gray (CPL) and

recorded by the person responsible for the work.

PROCEDURE IN THE EVENT OF A GAS LEAK

If you smell gas, or if a gas leak is reported to you: CALL THE TRUST SWITCHBOARD ON

0. THEY WILL INSTIGATE EMERGENCY PROCEDURES.

1. Ensure that all visitors and staff are moved to a place of safety. Evacuate the affected

building if necessary. DO NOT operate the fire alarm to do this.

2. Ensure no smoking. Do not use matches or naked flames.

3. Do not operate electrical switches including lights — either “on” or “off’.

4. Open doors and windows to get rid of the gas, and keep them open until instructed it is safe

to close them by British Gas Personnel.

5. Always check that a gas tap has not been left on accidentally or a pilot light has been

extinguished inadvertently.

6. If possible, turn off the gas supply at the meter. If you are unable to do this inform on

arrival Fire Service Officer, Gas Engineer or Estates Services Engineer.

7. Report the incident to Health & Safety Officers.

LABORATORY SAFETY PROCEDURES

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GENERAL

1. LABORATORY STAFF

Before any experimental procedure can be undertaken a COSHH risk assessment MUST be

performed and acted upon. Further details are given in following sections.

General Rules

1. Eye protection should be worn in all laboratories and must be worn when undertaking

potentially hazardous tasks.

2. Laboratory coats should be worn and properly fastened, even if the persons concerned are

not actively engaged in experimental work.

3. Other forms of protection such as gloves, visors, rubber aprons, respirators, safety screens

should be used as required.

4. Long hair must be tied back. Sensible shoes should be worn.

5. Researchers must be aware of the locations of First aid equipment including eye wash

bottles. Researchers must be aware of their locations. There is an emergency box

containing a spillage kit, goggles, long sleeve gloves and brush in the molecular lab.

6. Fire-fighting equipment must be readily available and its location known to researchers.

7. Gas cylinders must be adequately secured and turned off at the cylinder valve when not in

use. A control key must be left on the cylinder when a reduction valve is fitted.

8. Hazardous work must never be carried out alone at any time. A colleague must always be

within call; preferably in the same laboratory, although this latter may not always be

feasible.

9. Never handle materials or apparatus with which you are unfamiliar. Always seek skilled

advice in such circumstances.

10. Stab wounds and cuts are the most dangerous accidents. Minimise the use of sharp objects.

When such use is unavoidable handle with extreme caution. Wherever possible use plastic

instead of glass. Do not leave sharps lying around — put them in a safe container.

11. Clear up spillages immediately (see ‘Spillage Procedure’).

12. Clear and wipe your work bench with the appropriate disinfectant each time splashing or

spillage of biological materials occurs.

13. Pay particular attention to the rules regarding flammable liquids which are given in detail

later.

14. Disposal of needles and syringes – do not attempt to separate the needle from the syringe

barrel, do not resheath the needle. Carefully empty any residual contents of the syringe

into a waste container then discard the needle and attached syringe into a sharps container.

15. Eating, smoking and drinking are PROHIBITED in laboratories.

16. Good house-keeping in every sense is important. Tidiness and order are generally

associated with good accident-free records in laboratories. Benches ought to be kept tidy

and gangways must be kept free from obstruction.

17. Filling accident report form when an accident occurs.

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2. OTHER STAFF

The work of cleaning and other ancillary staff, including contractors, may involve the accidental contact

with hazardous materials. As well as the general precautions outlined, cleaning staff must also observe the

following safe working practices.

1. Always wear the overall provided and see that it is properly fastened.

2. Wash your hands often while at work especially after you have handled laboratory materials that

you have been instructed to wear gloves.

3. Do not touch any bottles, tubes, dishes or equipment on the laboratory benches. Do not dust or

clean any workbenches unless you have been specifically directed to do so by a member of the

laboratory staff or by your supervisor. Laboratory staff must make arrangements to let you know

what they want you to clean.

4. If you have an accident of any kind, or knock over or break any bottle, jar or tube, or piece of equipment,

tell your supervisor or one of the laboratory staff at once. You MUST make sure that the matter is

reported because the accident may have caused a hazard.

5. Do not attempt to clear up after any accident with laboratory items or materials. In the event of

an accident during working hours contact a senior member of staff

6. Never empty any laboratory waste containers unless an instruction is issued giving permission to

do so. Never empty the contents of waste bags.

7. Do not attempt to clean sinks in the radioactive waste isotopes lab.

3. VISITORS TO THE LABORATORY

All visits should be by prior appointment whenever possible.

All visitors including service engineers, should be advised to first report to the reception

area in the Guy Hilton Research Centre. Arrangements to meet them there, or a contact

number to summon the appropriate staff member MUST be made.

All laboratory visitors should be provided with a laboratory coat (and if necessary any other

protective equipment) before entering the laboratory area.

First-time visitors MUST be escorted whilst in the laboratories.

No children are permitted within the research buildings.

PERSONAL PROTECTIVE EQUIPMENT (gloves, aprons, masks, goggles, shoes)

Laboratory coats and safety spectacles must be worn when undertaking hazard laboratory work

and it is strongly recommended they are worn at all times in the laboratory areas, as other people’s

experiments may be a hazard.

a) All members of staff of whatever grade working at the laboratory bench must wear a properly

fastened protective white laboratory coat of approved design. Remove it before leaving the

laboratory. Cuffs should not show below the coat sleeve. When not in use coats must be hung

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on the hooks provided. Laboratory coats must not come into contact with outdoor clothes.

Dirty coats should be placed in the dirty linen bag and NOT left in the laboratory. If

contaminated, coats must be changed immediately.

Apart from giving some protection against minor spills, overalls help to prevent toxic

materials getting on the worker’s everyday clothing. Such materials may cause skin irritation

etc. and if allowed to build up on the overall may cause it to be a source of danger rather than

protection. Hands should not be wiped on either the overall or on laboratory dusters. Many

cases of hand burns and dermatitis have been caused through the careless use of laboratory

cleaning cloths.

b) Gloves should be the correct size and are disposable - except for heavy duty ones provided for

specific tasks (e.g. wash-up). When washing up dirty apparatus, protective gloves should be

worn, to prevent the possibility of skin damage.

c) Glasses, goggles and masks are available for working with samples, chemicals or glassware,

carrying a risk of explosion/implosion - such as pressurised bulbs or evacuated

bulbs/containers. This rule applies to the wearers of contact lenses since these can be very

dangerous if splintered in an eye accident. In most cases safety spectacles will suffice but full

face visors are available, should the experiment seem sufficiently hazardous to warrant it.

d) Shoes should be substantial with respect to splash-protection and safe movement throughout

the laboratory.

e) Respiratory protective equipment in the form of disposable masks or respirators that give

protection against nuisance odours and dust are available if the risk assessment calls for their

use.

PROCEDURE FOR SPILLAGE

The effect of an accidental spillage should be addressed as an integral part of the COSHH

assessment of all laboratory procedures. Any large scale work should be undertaken with caution,

and only after consultation with the Departmental Safety Adviser and, where appropriate, the

Radiation Protection Officer or GMO Biological Safety Officer. The descriptions below give some

guidance for relatively small scale spillages. Off the shelf kits are also available, for where

appropriate it may be advisable to purchase such kits as a part of safety precautions to be put in

place prior to undertaking the procedure in question.

In general for all spillages

• Contain the spill (e.g. switch off pump etc.)

• Do not allow anyone to inadvertently walk into the spillage area

• Place appropriate signs warning of the hazard

• If possible seal the area of the spill until it can be cleared up

• If necessary, seek further advice from the Departmental Safety Adviser prior to attempting

clean up

• Use sand or celite (or another inert material) to contain the spillage

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Blood/tissue/human fluids

The spillage should be first disinfected with an appropriate disinfectant (see section on human

samples and GMO Local Rules) and the area thoroughly decontaminated with the same

disinfectant.

Chemicals

Pouring of liquids from bottles must be done very cautiously. For example, care must be taken

when refilling reagent bottles from Winchesters particularly if the Winchester is full. The use of

plastic spillage trays for this purpose has much to recommend it. When pouring liquid from a large

container, resting on it so that the whole weight of container and contents is on the receiver, is very

dangerous. A variety of suitable transfer apparatus is now available from laboratory suppliers and

its use ensures speedy and efficient transfer.

Specific advice should be contained within the appropriate COSHH risk assessment for the

procedure. Strong acid and alkali spills should be neutralised as quickly as possible so that the

cleaning-up operation is less hazardous. Acid spills can be neutralised using a weak base such as

sodium carbonate or sodium bicarbonate (baking soda), then mopped up with a large diluting

volume of water. Alkalis can be neutralised using a weak acid such as ascorbic acid, boric acid or

citric acid and then mopped up with a large diluting volume of water. The BDH wall chart

‘Dealing with Spillages of Hazardous Chemicals’ should be consulted, copies are on the corridor

walls in the Guy Hilton Research Centre.

Spillages of mercury are very dangerous since poisoning by mercury vapour is slow, insidious,

cumulative and often unrecognised before irreversible damage is done. Small mercury spills can

be cleaned up using the mercury spill kit located in the Emergency box (Molecular lab). If it is

suspected that a laboratory is contaminated with mercury vapour then the DSO should be

consulted for the appropriate monitoring to be carried out.

Note: Do not use mercury filled thermometers if it is not necessary. Use alcohol filled

thermometers.

lf material is spilt on an individual then priority must be given to immediate treatment of that

person with regard to washing off the chemical, removal of contaminated clothing and any

necessary first aid.

PROCEDURE FOR A MAJOR SPILLAGE In the event of a major spillage:

1. GET HELP. Inform your supervisor or senior member of staff who will in turn inform the

Safety Adviser or their Deputy. The Safety adviser will decide whether to operate the

information cascade system. The spillage clearing kits are available in a box stored in the

Molecular lab.

DO NOT ATTEMPT TO DEAL WITH THE SITUATION ALONE.

2. The Safety adviser or their Deputy will

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a) Seal the area.

b) Identify the hazard/hazards.

c) Carry out an immediate risk assessment having due regard for:

i) whether the building needs to be evacuated.

ii) whether expert help and advice is required.

d) Advise staff who may have become contaminated.

e) Advise and co-ordinate the decontamination procedure having due regard for:

i) the level of personal protective equipment needed.

ii) the appropriate disinfection method required.

f) The Safety adviser having consulted with Keele HSU and others as appropriate will

decide when the area can be reopened.

FUME HOODS

There are three principal uses to which fume cupboards are put:

a) Removal of toxic fumes in the course of experimental procedures.

b) Confinement of potentially dangerous reactions.

c) Storage of toxic and corrosive substances which may emit harmful vapours.

The use for storage is not compatible with the use for potentially dangerous reactions and no

experimental work should ever be carried out in a fume cupboard in which dangerous chemicals

are stored, because of the danger of escalation of a minor accident into a major one. Therefore,

before using a fume cupboard for experimental work, all bottles and apparatus not being used for

the moment should be removed to a safe storage area. Make sure that the sash can be closed

quickly without disturbing the apparatus. Further, the rate of release of any toxic gases must not be

such as to cause the effluent from the fume cupboard to escape to contaminate the laboratory. If it

is suspected that this is the case, the DSA will be able to inform you as to the rate of flow of air

through the cupboard and its suitability for adequate containment of the toxic materials concerned.

If equipment has to be left in a fume cupboard a proper notice must be put up reserving the fume

cupboard, indicating any hazard involved and carrying the signature of the person concerned.

When the experimental work is completed, the cupboard should be cleaned out and any unwanted

products disposed of in the appropriate manner.

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GAS CYLINDERS

Check levels and do not operate them unless you are sure how they work.

a) Gas cylinders must only be transported singly using a cylinder trolley.

b) Do not roll cylinders on their bottoms or carry them by their valves.

c) Ensure that they are securely clamped to a wall or bench.

d) Never connect a cylinder directly to glass apparatus.

e) Do not vent inflammable gases before connecting to the apparatus.

f) Cylinders should not be stored near a source of heat.

g) Never use force on gas cylinder valves.

h) Never grease cylinder valves.

i) Use only approved cylinder keys, gauges, spanners, mallets, hammers.

j) If you suspect a cylinder is leaking, turn off the cylinder head valve and inform the safety

officer or deputy.

k) Never check cylinders for leaks with naked flames, use soapy water and look for bubbles or a

proprietary leak detector.

l) A spare cylinder should always be available, suitably restrained, for change-over when and

‘in use’ cylinder becomes empty.

m) Keep gas stores tidy - free from litter.

n) Lock stores as required (key in stationery cupboard in the labs)

o) Place all empty cylinders in the empty cylinder store.

p) Do not over-stock dangerous gases.

q) If in doubt—ASK!

ELECTRICAL EQUIPMENT - GENERAL POINTS

All new equipment will be checked for acceptance by the Estates to ensure that it conforms to the

current safety standards before it is brought into use.

a) Equipment malfunctions, including shocks, must be reported immediately to a senior

member of staff.

b) Blown fuses usually mean faults - consult an appropriate electrician/electronics engineer.

c) Never remove the cover from electrical equipment without authority.

d) Turn off and unplug any equipment suspected of being contaminated with water.

e) Do not operate electrical equipment with wet hands.

f) If you think that piece of electrical equipment constitutes a safety hazard, put a notice to that

effect on the equipment and tell a senior member of staff

g) Organic solvents with low flash points (e.g. ether) must never be placed inside refrigerators

because on the danger of explosion resulting from arcing of the refrigerator thermostat

contacts.

h) Electrical equipment not in use and not requiring a long warm-up period should be isolated

from the mains overnight (unplug).

i) Electrical leads of small pieces of apparatus should enter the equipment via a grommet. It is

possible for the insulation to become worn at this point, therefore such leads should be

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regularly checked.

USE of CENTRIFUGES

1. Operation

Centrifuges must not be operated at a speed in excess of that recommended by the maker.

This speed will generally relate specifically to the head and should be stamped on it. The

head must not be overloaded and the buckets must be properly balanced. If there is any sign

of undue vibration on starting up, the centrifuge must be stopped and the load rechecked

for balance. Corrosive, toxic or inflammable substances must be centrifuged in closed

containers.

Centrifuges must never be operated with the protective cover open and no attempt should

be made to stop the rotating parts by hand even after switching off. Centrifuges should be

thoroughly examined by a competent person at least once a year, and the appropriate

maintenance implemented to ensure that hazards are kept to a minimum. Effective covers

should be provided to prevent access to the high speed rotating parts and such covers

should, wherever reasonably practicable, be suitably interlocked to switch off the power

and apply a brake immediately the cover is raised.

2. Routine Maintenance

a) Always balance containers and buckets. (Centrifuge buckets and trunnions must be paired by

weight)

b) The centrifuge must be inspected after each run for signs of spillage.

c) The centrifuge must be inspected weekly for signs of wear: defects/corrosion/cracks. Also

check trunions and buckets are lubricated so they swing freely.

d) Centrifuge buckets may be routinely autoclaved weekly.

e) Centrifuge bowls are routinely cleaned weekly and disinfected with 70% isopropanol, gloves

must be worn. Wipe off with a damp swab, then dry. Discard all swabs into autoclave waste.

f) Disposable gloves are used for ALL cleaning operations.

g) Never use centrifuges inside a safety cabinet.

h) Whenever samples containing human material are centrifuged they should be placed in

sealed centrifuge buckets, preferably with ‘see-through’ top.

3. Suspected breakage inside sealed buckets of centrifuge

1. Always discuss with senior staff before attempting to salvage leaked specimens.

2. Wear gloves.

3. Remove the bucket to a safety cabinet before opening.

4. Disinfectant or autoclave bucket and lid.

5. In the event of a known spillage/breakage within the sealed bucket, this is removed and

autoclaved automatically providing the sealed bucket is capable of withstanding high

temperature and pressure.

6. Plastic buckets and trunnions may be immersed in 10% bleach immediately.

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4. Suspected breakage inside sealed buckets of centrifuge

a) Inform a senior member of staff or the DSA.

b) Where Glutaraldehyde is required (metal surfaces) an authorised user should wear

gloves.

c) Turn off centrifuge at mains.

d) Leave the lid unopened for 30 minutes (to reduce aerosol risk).

e) Remove any broken glass with thick gloves, forceps or swabs and dispose of safely.

f) If possible remove inside bowl to fume-cupboard preferably at the end of the day.

g) Thoroughly disinfect the bowl and lid with 2% glutaraldehyde leave for 10 minutes.

Wash and wipe with water. Allow to dry.

h) Buckets are recovered for disinfection or autoclaved (see above).

i) See below for glutaraldehyde use (Consult senior staff/DSA).

THE USE OF GLUTARALDEHYDE

1. Who may use Glutaraldehyde?

• Only authorised members of staff are allowed to use glutaraldehyde with the

exception of an incident arising outside normal laboratory hours.

2. Staff Monitoring

• Authorised glutaraldehyde users are monitored by the Trust/Keele Occupational

Health Department/Unit. In the event of the need to use glutaraldehyde out of normal

laboratory hours the person involved must report the incident to the DSA. They will

decide the need for any further action.

3. Storage/Activation/Transport

• Glutaraldehyde must be activated within a Class 1 cabinet. The container must be dated

with the expiry date and signed by the person activating the disinfectant. The operator

must wear gloves and have access to an approved respirator.

• When glutaraldehyde is transferred to another laboratory a carrier rack must be used.

4. Uses of Glutaraldehyde

• Glutaraldehyde is used only for disinfecting a centrifuge prior to servicing.

• Glutaraldehyde may also be used in event of a spillage within the centrifuge.

• Exceptionally glutaraldehyde may be used for spot disinfection of metal equipment

but only when no other disinfectant can be used.

PROCEDURES FOR USE OF LASERS

1. In accordance with the CVCP Guidance Notes for lasers, the University has set up an

administrative organisation for the control of laser operation within the University. This body

reports to the University Occupational Health and Safety Committee.

2. There are 4 classes of laser (described in the CVCP Guidance Notes for Lasers). Class 1 lasers

and lasers found in equipment such as printers and CD ROMs are exempt. These lasers must

only be serviced by qualified staff and any damage to such equipment should be reported to

the Head of Department immediately.

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3. The University Medical Adviser on lasers is the Occupational Health Nurse Manager who

arranges for eye examinations following exposure or suspect exposure to laser radiation.

4. The University has designated the University Laser Safety Officer (ULSO), the University

Safety Adviser, who is a member of the body set up under 1 above and who arranges for the

registration of all laser users

5. All new laser users must register first. The registration form is available on-line at

http://www.keele.ac.uk/depts/vc/plansec/H&S/wordfiles/laserregform.doc

The hard copy of the registration form is required to keep in Department laser safety officer.

6. All laser users must attend the initial safety training by watching laser safety training video. A

copy of this video and DVD disc are kept in Dr Yang’s office. You can make arrangements to

view the video or DVD. Having seen the video or DVD, the potential laser user must enter

their names and sign in a recorded sheet.

7. A laser safety risk assessment must be completed, checked and agreed with the departmental

laser safety officer BEFORE the laser is powered up. The laser safety risk assessment should

be done in conjunction with a full risk assessment of your experiment. If the assessment has

been performed by a previous user in the group, the new user must read the assessment and

ensure fully understanding of the content of the documents. Only the person who has been

trained can access the laser key (for Optical tweezers)

Duties of Staff Supervising the Use of Lasers:

1. To be responsible to the Head of Department for the safe operation of all lasers under their

control.

2. In consultation with the DLA and ULSO to prepare written schemes of work for the use of lasers

(class 2 and above) under their control.

3. To inform the Head of Department, DLA and ULSO before any lasers (class 2 and above) are

brought on to the University premises.

4. To arrange for adequate personal protective equipment for laser operators.

5. To arrange for adequate monitoring/safety inspections of laser equipment and maintain records

of these inspections. These records should be inspected annually by the DLA and copies

forwarded to the ULSO.

6. Laser users must be aware of their responsibilities which include:

7. Attending any instruction courses recommended by the Head of Department, DLA or ULSO.

8. Using a laser with the minimum of power and energy which the experimental conditions allow.

9. Following the written schemes of safe work (and informing the DLA if these written schemes

become unsafe) and actively co-operating in developing and updating a safe working

environment.

These guidelines also apply to all categories of University staff and staff from other institutions

operating lasers on University premises or University staff operating lasers in other institutions.

PROCEDURE FOR USE OF RADIATION

1. The common ionising radiations are X-rays and the emissions from radioactive materials. At the

present, there is no active license permitting any work with radioactive materials to be undertaken

in Hartshill Campus. If you have a plan to use radioactive materials, contact with the Radiation

adviser in advance.

18

2. All X-ray users must attend the initial radiation safety training run by University annually. If you

miss the training time, an on-line training programme is available in Keele web site:

http://www.keele.ac.uk/admin/hr/ohsu/rad/#List

3. You should report your training to radiation adviser before you undertake practice work on X-ray.

4. A X-ray safety risk assessment must be completed, checked and agreed with the departmental

radiation safety officer BEFORE the X-ray is used. The X-ray safety risk assessment should be

done in conjunction with a full risk assessment of your experiment. If the assessment has been

performed by a previous user in the group, the new user must read the assessment and ensure fully

understanding of the content of the documents. Only the person who has been trained can access

the X-ray facility (MicroCT room).

PROCEDURES FOR IMPLEMENTATION OF COSHH

This section is intended as a preliminary statement of the University’s policy on the implementation

of the Control of Substances Hazardous to Health (COSHH) Regulations 1999 and as guidance on

action to be taken by departments and by individuals. The Regulations have been in force in all

respects since January 1990 and it is important that we satisfy the Health and Safety Executive that

we comply in full with the Regulations.

As far as the University is concerned, all hazardous substances are covered by these Regulations

apart from

a) lead compounds

b) asbestos

c) substances that are hazardous to health solely by virtue of their radioactive, explosive or

flammable properties or by virtue of being held at high or low temperature or at high pressure.

Substances in these three categories are covered by other Regulations.

All persons having managerial responsibilities for employees, students or visitors to the

University who might be exposed to hazardous substances must be familiar with such of the

COSHH Regulations as are necessary to enable them to carry out these responsibilities.

All laboratory workers MUST receive training in the implementation of COSHH and

procedures for undertaking risk assessments in relation to their work with hazardous

substances and / or biological agents.

Copies of relevant COSHH publications are available from the DSA or research secretary in

ISTM.

Of the nineteen regulations, numbers 6 to 12 inclusive are the most important. These are:

Regulation 6. Assessment of health risks created by work involving substances hazard

19

to health.

Regulation 7. Prevention or control of exposure to substances hazardous to health.

Regulation 8. Use of control measures etc.

Regulation 9. Maintenance, examination and test of control measures etc.

Regulation 10. Monitoring exposure at the workplace.

Regulation 11. Health surveillance.

Regulation 12. Information instruction and training for persons who may be exposed

to substances hazardous to health.

At the departmental or individual level, it is Regulation 6 which will need most attention.

Assessment of health risks created by work involving substances hazardous to health

6.1 Subject to Regulation 17(1) (which relates to transitional provisions) an employer shall not

carry out any work which is liable to expose any employees to any substance hazardous to

health unless he has made a suitable and sufficient assessment of the risks created by that

work to the health of those employees and of the steps that need to be taken to meet the

requirements of these Regulations.

6.2 The assessment required by paragraph (1) shall be reviewed forthwith if

a) there is reason to suspect that the assessment is no longer valid or

b) there has been a significant change in the work to which the assessment relates,

and, where as a result of the review, changes in the assessment are required, those changes shall be

made.

The University will interpret “employees” in the Regulation as including students and visitors. For

Postgraduate Medicine, this includes everyone working at the Postgraduate Medicine site,

including NHS Trust employees.

Responsibility for Carrying out Risk Assessment

1. The head of a department is responsible for ensuring that a scheme is published, so that all

members of the department know who is responsible in each case for carrying out the risk

assessment. The HOD (advised by the DSA) is further responsible for deciding on training

needed by individual staff who carry out risk assessments. The HOD must check at

appropriate intervals that the assessment are being carried out in a satisfactory manner.

2. Responsibility for risk assessment should not be assigned to junior or inexperienced staff,

nor to staff who do not have full executive control over the procedures for which the

assessment is needed.

One member of the staff (e.g. the Safety Adviser) must not be made responsible for all assessments

in the department unless few hazardous substances are used and this member has particular

expertise in this area.

20

In general, the most senior person involved in a particular work activity must take responsibility

for the risk assessment.

Responsibility for risk assessment for routine experiments out by undergraduate students rests

with the member of the academic staff who devised the experiment. Responsibility for risk

assessment with undergraduate project experiments or with postgraduate experiments rests with

the project supervisor. It may be considered desirable for educational/training purposes for

students or for junior staff to prepare risk assessments, but the responsibility remains with their

supervisor.

Basic Principles involved in Risk Assessment

a) The function of the risk assessment is to recognise, evaluate and make recommendations

for control in respect of any risk.

b) It is very important to distinguish between the hazard potential of a substance and the

health risk of that substance in actual use. For example, the health risk due to a bottle of

potassium cyanide is quite different if:

a) it is securely stored in a well ventilated locked poisons cupboard in a

departmental store;

b) it is stored on an open reagent shelf in a laboratory to which there is free access;

c) it is made up into solutions by inexperienced students.

The risk assessment of an experiment procedure must concern itself with the hazards which are

actually relevant to the experiment procedure itself.

It follows from this that a department will find risk assessments simpler if all substances that are

not in constant use are kept in secure storage areas. A department will also find risk assessments

simpler if it disposes of chemicals etc which are unlikely to be used again.

c) Departments should decide as quickly as possible which substances constitute the greatest

risk and should carry out risk assessments for these substances first.

d) In departments in which a relatively small number of hazardous substances are used in

relatively routine procedures it may be found that risk assessments will require little

modification after their initial drafting. It is important, however, that they are checked

periodically to see whether they are still appropriate. Departments may find that they can

collaborate on assessments for substances used in common.

e) In departments in which reaction chemistry is carried out or in which hazardous

substances are used in non-standard ways, risk assessment will be necessarily more

complicated to perform. However, there may be many ways to simplify the assessment.

For example, research groups carrying out complex reaction chemistry may nevertheless

find that the reactions carried out fall into a small number of Categories, each category

21

requiring a single assessment.

f) Groups of substances may also be used in ways that could be covered by a single assessment

per group. It may then be possible to assign a new experiment to standard risk assessments with

only limited features of the experiment requiring special treatment. If it is possible to do this,

each experiment will still need to be considered by an experienced senior and responsible

member of staff.

Risk assessments must be written in such a form that they can be clearly understood by staff or

students carrying out the procedures. All such staff and students will be required to be familiar

with the assessment and it will he one of the tasks performed by both departmental and

University inspection teams to spot check that students and staff do understand the assessment.

RISK ASSESSMENT PROCEDURES

Assessments of individual experiments/procedures MUST be carried out on the appropriate

departmental risk assessment forms. These are designed to be completed on a PC and then hard

copies printed off for signatures and distribution. Explanatory notes are contained within the files.

Blank forms and the database of the existed COSHH form can either be obtained on disk from the

DSA or downloaded from the departmental website:

http://www.keele.ac.uk/istm/informationforstaff/healthsafety/coshhdocuments/

Completed assessments MUST be read and understood by those undertaking the

procedures (even if they did not carry out the original assessment). Copies are available in

the laboratory where the procedures are being performed or from website (the same address

as above) or from Ms Paula Marsh.

It is recommended that having carried out the risk assessment(s), this information should be used

to produce a Standard Operating Procedure (SOP) for the particular activity or linked series of

procedures. This document should contain specific instructions for carrying out the activity and all

the necessary accompanying safety information (highlighted in the risk assessment). An SOP

proforma is available which can be completed on a PC and as before blank forms may be

downloaded from the departmental website, given above. Forms should be kept by the individual

workers for daily use.

TRAINING

As part of the induction process training sessions will be held at least annually for new workers for

guidance on completion of risk assessments and general overviews of compliance with the

COSHH regulations.

Strategies for Reducing Risk

The principal strategy needed to reduce risk to an acceptable level is the adequate containment of

22

toxic material. This will be achieved by appropriate design of apparatus and equipment.

Where it is difficult to guarantee a high level of containment or where a malfunction of the

experiment or procedure leading to non-containment is foreseeable fume cupboards will play an

important role in reducing risk.

Important aspects of fume cupboard use include the following:

a) The fume cupboard must have appropriate performance characteristics for the work

carried out in it.

b) The apparatus geometry must not be such that it interferes with the fume cupboard

performance.

c) The fume cupboard performance must be tested at appropriate intervals, at least once

every 14 months and maintenance records kept.

d) A fume cupboard must not be used to vent substantial amounts of toxic vapour to the

atmosphere during normal operation of experiments etc. When a procedure generates

large amounts of vapours these should normally be trapped.

In work areas (e.g., offices) in which small quantities of solvent are used occasionally appropriate

ventilation together with reasonable care will be all that is needed to reduce risk to an acceptable

level.

In laboratories or work areas in which large quantities of toxic material are used a monitoring

strategy may have to be devised. This will involve air sampling and analysis.

In areas where solvents are used regularly a good test of whether air concentration of a material is

excessive is whether the users of the area can smell the material. If they can do so then action needs

to be taken. Smell often acts as a warning and for this reason toxic gases or volatile material with

no discernible smell (e.g. carbon monoxide) must only be used in conjunction with an alarm

system triggered by vapour concentrations.

Solvent removing devices such as rotary evaporator must only be used when there is adequate

trapping of the vapour.

Substances with offensive odours at concentrations below their exposure limits should also be

contained so that the smell is undetectable since offensive odours cause considerable nuisance to

other workers.

HAZARD INFORMATION

Since the introduction of the Classification, Packaging and Labelling Regulations 1984 (CPL)

suppliers have been required to label hazardous substances with symbols and risk phrases

indicating hazard, and with appropriate safety phrases. The departmental risk assessment forms

include an appendix with this information.

Note that when University departments act as suppliers they are bound by the CPL Regulations.

Basic hazard information should therefore be provided on bottles, etc. supplied and this should be

23

transferred to any new container that the material is placed in.

Containers that were supplied some time ago or have come directly from another country or have

been supplied for example by other University departments may be inadequately labelled. Such

containers must be provided with adequate labelling.

Further hazard information may be obtained from suppliers via materials safety data sheets

(MSDS). These can be requested from the supplier and should be automatically sent with the first

order of a reagent. Two compendia published by manufacturers will be found to provide

information on most hazardous substances (other than novel compounds synthesized in chemical

research). These compendia are provided by:

a) B.D.H./Merck — this is book form and the manufacturers will provide one free copy to

each department purchasing their products.

b) Aldrich — catalogue

There are also many resources on the web:

http://www.sigma-aldrich.com

http://www.bdh.com/sds/sds search.htm

http://www.hazard.com/msds/links.html

Hazardous substances that might be present in the air may be assigned concentration limits

(see EH4O guide listed at the end) which (depending on the substance) are presented in one of two

forms:

1. Exposure limits

These air concentration values must never be exceeded.

2. Exposure standards

When these values are exceeded action must be taken to reduce the concentrations. The

concentrations are expressed in parts per million of material in air (p.p.m.) or in mg of

material per cubic metre of air. Two values are given:

a) short term limits (over a 10 minute period), and

b) long term time weighted average (over an 8 hour period).

Because of the importance of inhalation the capacity of material to become airborne is

important. Consequently the risks associated with gases, volatile liquids or dusty

solids are greater than those associated with involatile liquids or non-dusty solids

having the same exposure limits or standards.

RISK AND SAFETY SYMBOLS

Physico-chemical Category Symbol Indication Symbol

of danger letter of danger

Explosive E Explosive

Oxidising 0 Oxidising

24

Extremely F+ Extremely

flammable flammable

Highly F Highly

flammable flammable

Flammable - Flammable

Health Very toxic T+ Very toxic

Toxic T Toxic

Harmful Xn Harmful

Corrosive C Corrosive

Irritant Xi Irritant

Sensitising Xn Harmful

Xi Irritant

Carcinogenic T Toxic

Categories 1&2

Category 3 Xn Harmful

Mutagenic T Toxic

Categories I &2

Category 3 Xn Harmful

Toxic for

Reproduction T Toxic

Categories 1&2

Category 3 Xn Harmful

Consult the appendices in the COSHH risk assessment forms for further hazard information and

guidance.

PUBLICATIONS

Copies of the following useful references are available from the School of Medicine.

1. COSHH Approved codes of practice, published by Health & Safety Executive (HSE)

1999. Contains general, carcinogen and biological agents, regulatory information.

ISBN 0717616703

2. COSHH Approved codes of practice, published by HSE 2001. As above with some

additional updates. ISBN 0337094950

3. EH4O/2001 Occupational Exposure Limits 2001, published by HSE 2001. Contains

limits and guidance for hazardous substances covered by COSHH regulations. ISBN

071761977X

4. Advisory Committee on Dangerous Pathogens (ACDP): The management, design

and operation of microbiological containment laboratories, published by HSE 2001.

Covers all aspects of working in biological containment laboratories. ISBN 0717620344

5. ACDP: Categorisation of biological agents according to hazard and categories of

containment (4th edn.), published by HSE 1995. Useful general guide with examples for

GMO users, although lacks updates in relation to cell culture. ISBN 0717610381

A guide to the Genetically Modified Organisms (contained use) regulations 2000,

25

published by HSE 2000. GMO regulatory bible. ISBN 0717617580

Often, useful updates and supplements to these resources are released through the HSE website

and some may available to download from there: http://www.hse.gov.uk

PROCEDURE TO WORK WITH HUMAN TISSUES

Definitions

‘Human material’, in the context of this document, includes blood samples, urine, tissue

samples, and any other material of human origin (e.g. cerebrospinal and other fluids).

General guidelines

1. Person handling biohazardous material should be immunised against Hepatitis B and their

response to the immunisation checked. The accuracy of this information must be updated at

least annually by the group heads and recorded centrally (see Jeanette Forrester).

2. No person who has not been trained by a senior staff member (supervisor or delegated deputy),

and authorised to do so, is allowed to handle human specimens.

3. All persons proposing to handle such specimens must first be thoroughly familiar with the

contents of this protocol and other associated procedures referred to herein.

4. Full risk assessment must be performed on all standard operating procedures using human

material prior to use by any personnel (including senior staff). Subsequently, the relevant risk

assessments must be read and understood (with signed confirmation that this has been done) by

all staff prior to performing the procedure.

5. All personnel handling human material must first have read and signed that they have

understood the laboratory safety manual.

6. Processing of samples must be performed in dedicated areas.

7. Only designated areas are to be used for the storage of samples of human material.

8. CJD patient samples- contact head of dept, or Consultant Microbiologist (Dr Gray or Dr

Orendi) immediately for advice before handling!

9. Facilities for the handling of samples with a high probability of infection risk are not available

within the Keele laboratories.

10. For activities relating to materials covered under the Human Tissue Act a Biological Risk

Assessment should be performed first followed by a detailed breakdown of the associated

activities/process in the generic ISTM COSHH form

(http://www.keele.ac.uk/istm/informationforstaff/healthsafety/humantissuesdocuments/)

Risk assessments

1) A risk assessment (RA) describes the steps taken to identify a hazard and a measure of the

probability of risk occurring due to that hazard.

2) Risk is the chance of injury, damage or loss.

3) A hazard is something that is, or has the potential to be, dangerous. These can be;

a) Physical

b) Chemical

c) Biological

26

4) Risk assessments should be suitable and sufficient such that appropriate levels of depth,

control and monitoring are applied.

General

1) A RA must be generated in advance for each new protocol implicated in the handling of human

tissue.

2) A RA should be undertaken for each staff member identifying specific risk areas which they

are exposed to and what measures can be applied to minimize that risk.

3) The individual RA should identify

a) Work which cannot be undertaken without direct supervision by a person of responsibility

b) Work which requires prior instruction on safe working by a person of responsibility before

it can be started

c) Work which presents little hazard and can be safely carried out without prior instruction.

4) This should be performed;

a) When that person starts work.

b) Minimally on an annual basis.

5) Included in the RA should be the relative dangers associated with handling;

a) Biological specimens

b) Infectious agents

c) Chemicals and solvents

d) Equipment

6) Where the protocol involves handling human tissue has the risk of patient identification been

eliminated?

7) In all instances it is the responsibility of the human tissue handler or experimental practitioner

to identify and minimize the risk exposure.

8) An RA should only be performed by a practitioner who has sufficient knowledge of;

a) Hazard Identity.

a. Physical

b. Chemical

c. Biological

d. Equipment

b) Associated hazard safety procedures.

c) Laboratory safety features.

d) Knowledge of governing regulations

9) The category into which each operation is placed will be made by the person of responsibility

with due attention given to the likelihood that the operation can be carried out safely with the

defined amount of supervision, not on whether time is available to give that supervision.

10) All active RAs should be reviewed , minimally, annually and/or whenever a modification

occurs to the laboratory which may have an impact on the RA;

a) New employee.

b) New reagent.

c) New equipment.

11) Where a hazard cannot be reasonably controlled, the risk must be transferred to those

competent to deal with it e.g. a supervisor, responsible person, specialist contractor.

27

Performing a risk assessment

1) Evaluate laboratory features

a) Physical facility

i) Air Flow

ii) Access

iii) Structural composition.

b) Containment equipment

i) Safety cabinets

ii) Fume hoods

c) Personnel

i) Experience

ii) Training

iii) Immunization

iv) Disability

2) Evaluate procedural features.

a) Biological/Chemical agent

i) Pathogenicity

ii) Mode of transmission

(1) parenteral

(2) blood

(3) ingestion

iii) Information available e.g MSDS

3) Procedures performed

i) Aerosol generating

ii) Use of syringes and needles

iii) Extreme temperatures

iv) Sterile technique

4) Assess features and categorize risk

a) Do any features carry with them a risk of;

(1) Death or cause permanent disability

(2) Long-term illness or serious injury

(3) Medical attention and several days off work

(4) First aid needed

b) Judge the likelihood of it happening

i) High

ii) Medium

iii) Low

iv) Very low

5) Maximize efforts to minimize risk to Low/Very Low likelihoods in all instances.

Training requirements for handling

1. Only staff that have completed training by a senior staff member are permitted to handle

human material. This must include practical assessment of the contents of this document,

associated general standard operating procedures (e.g. use of centrifuges, safety cabinets, etc)

as well as specific SOPs. In addition, formal training sessions in handling such materials will

28

be given. Those performing procedures involving human material must either have attended,

or registered to attend one of these sessions.

2. Formal training will consist of a 1 hour session on the principles of handling materials.

Practical training by senior staff must consist of observation followed by supervised

performance of the procedure. Once training is at a satisfactory level as assessed by a senior

staff member, this must be recorded as a signed document of assessment.

3. Senior staff must ensure that standards are maintained by performing annual spot checks to

ensure compliance with written protocols.

4. Designated safety personnel will perform annual random independent spot checks to assess

compliance.

Acquiring Human Samples

NRES Route

1) Before undertaking any study which involves an application for NRES-approval the use of

human tissue samples local rules require that Independent Peer Review (IPR) is first obtained

2) Following on from successful IPR approval must then be sought for any study from the NHS

Research Ethics Committee (https://www.nresform.org.uk). This procedure will be performed in

close collaboration with the participating clinician and the UHNS R&D (see Dr Darren Clement,

detailed above). Application will be made to the relevant Local Research Ethics Committee

(LREC) through this portal.

3) The Chief Investigator of any study which has successfully obtained LPR and LREC approval is

responsible for the secure storage of signed participant Consent Forms and of all approval

documentation. This documentation must be made available for inspection upon request by any

Secretariat-approved internal or external auditing body.

4) Where tissue samples are obtained from hospital sources other than University Hospital of

North Staffordshire it is envisaged that Chief Investigators will act in close collaboration with the

pertinent R&D departments.

5) Where tissue samples are obtained from non-hospital sources such as Tissue Banks (e.g. NBTS,

Parkinson’s Disease Brain Bank) the Bank will have established Consent procedures. While

research using Bank materials will still require LREC approval the Chief Investigator will not have

accompanying Consent documentation and covering material from the Bank will suffice in this

instance.

Consent Route

1) Human tissues obtained under Consent but without NRES approval must be logged upon entry

and Nick Forsyth or Paul Eggleston immediately notified and shown the signed consent form.

2) Human Tissues obtained under consent but not for a NRES-approved project must be obtained

whilst following the guidelines outlined in the University Hospital of North Staffordshire

document Policy No. (C43) Policy and Procedures for Obtaining Consent (including the

application of the Mental Capacity Act 2005).

29

Human Stem/Primary Cell Samples

Human Embryonic Stem Cells

All work carried out using Human Embryonic Stem Cells (hESC) must have received prior

approval from the UK Stem Cell Bank.

All hESC should be sourced from either the UKSCB or where an alternate source is required it

should be done only once a UKSCB ‘Approval to Import’ has been granted. All hESC lines must

be logged into the Stem/Primary Cell Logbook located at the reception of the GHRC.

Mesenchymal Stem Cells

All human mesenchymal stem cells (hMSC) lines must be logged into the Stem/Primary Cell

Logbook located at the reception of the Guy Hilton Research Centre.

N.B. If bone marrow aspirate is used this must first be logged in the Tissue Book. Once removed

from the recovery vessel and inactivated the aspirate must be marked as disposed of in the Tissue

Logbook. Following disposal of aspirate a new entry must be entered in to the Stem/Primary Cell

Logbook located at the reception of the Guy Hilton Research Centre.

Primary Cells

All human primary cells must be logged into the Stem/Primary Cell Logbook located at the

reception of the Guy Hilton Research Centre. Where these are recovered from Human Tissue

samples the procedures outlined previously for obtaining the Human Tissue must first be followed.

In addition when the Human Tissue enters the building it must first be logged in the Human Tissue

Log and once disposed of it must be marked accordingly.

Other sources

When obtaining cells from other sources i.e. commercially, researchers must first obtain a clear

ethical statement from the commercial supplier that the materials have been obtained under

practices which are deemed appropriate to those laid down by the Human Tissue Authority and the

EUCTD.

Human blood products (eg research-designated donor blood from the National Blood Service)

Record Keeping

All records must be maintained in a secure environment. This can be in either a secure, locked,

metal filing cabinet or alternatively, in a password protected device. The responsibility for the

maintenance of all records concerned with the acquisition of Human Samples (Tissue or Stem

Cells or other relevant material as defined by the Human Tissue Act (2004)) lies with the principal

investigator or chief investigator overseeing the research.

Handling Human Tissue Samples

Designated laboratories

1) Facilities for the handling of samples with a high probability of infection risk are not available

within the Keele laboratories.

a) These include samples from;

30

i) IV drug users.

ii) homosexuals.

iii) some tattooed individuals.

iv) known positive HIV patients.

v) known positive Hepatitis patients.

b) If such samples are received, contact a senior staff member who will dispose of the sample.

2) The currently designated areas for Handling Human Tissue Samples are;

GHRC - labs 2, 4, 5, 6, 11, and 13 (Medical Research Unit); Genomics lab (Keele Labs); and

Clean Utility, Laser Lab, SIFT lab, cell culture Room, Molecular Lab, Histology, Biomaterials,

Magnetics, Microwave Lab, CT Scanner, and the Cell Therapy Suites.

3) Tissue samples should not be placed within any office area at any time.

a) Tissue samples discovered in any office area will be quarantined and dispatched for

incineration.

4) Tissue samples should not be placed in any common area at any time.

a) Tissue samples discovered in any office area will be quarantined and dispatched for

incineration.

5) All processes involving handling of human samples must be performed in the designated areas

where the surface is impervious to water, resistant to acids, alkalis, solvents and disinfectants,

and is easy to clean.

6) If the procedure involves the potential to produce an aerosol (e.g. involves vigorous shaking,

mixing, homogenisation or ultrasonic disruption), it must be performed in a safety cabinet

including fume cupboard. These are located in;

GHRC - labs 2, 4, 6, 8, 11, and 13 (Medical Research Unit); and SIFT lab, cell culture room,

Molecular Lab, Histology, Biomaterials, Magnetics, and the Cell Therapy Suites.

7) All other aspects of the procedure should be performed in a fume hood or other suitable sterile

area.

Techniques

1) Before handling any tissue ensure that appropriate training has been received in handling

reagents associated with specimen handling. If unsure contact a responsible person.

2) Where possible, process samples in batches. This reduces the time spent handling human

material.

3) Where possible minimize the use of sharps in any procedure involving human material e.g.

Glass pipettes, scissors, scalpel blades, dissecting forceps.

4) To minimize risk in the event of spillage or breakage do not store sharps in designated

handling areas.

5) Wash your hands frequently during the course of your daily work and always before a

break and at the end of the day.

6) Wash hands immediately if they become, or you suspect they have become contaminated

by a sample.

7) As infection can occur by parenteral (diffusion through the intact skin, diffusion through

mucosal membranes, inhalation) inoculation, it is of paramount importance that when

handling infectious material, contamination of surfaces is controlled. For instance

a. Existing cuts and abrasions and other skin lesions should be properly protected and

accidental self-inoculation and splashing of mucous membranes be avoided.

31

b. Any puncture wound must be treated immediately by encouraging bleeding and

liberally washing with soap and water.

c. Puncture wounds or contamination of mucous membranes or broken skin must be

reported promptly to the Head of Department, Senior Laboratory Staff and

Consultant Microbiologist (e.g. Dr Gray, Dr Orendi, Central Pathology

Laboratory) and recorded by the person responsible for the work.

Personal Protective Equipment (PPEs)

Personal protective equipment must be used throughout procedures involving human tissue.

Always contact a senior staff member if unsure of level of protection required.

Individual standard operating procedures (and attached risk assessment documents) determine

specific levels of protection required. These include:

1. Generic

1) Short trousers are not permitted.

2) Open-toed footwear is not permitted.

3) Long hair (shoulder length or greater) should be tied back.

4) Decorative accessories should not be worn in a designated Human Tissue Handling laboratory.

These items should be stored in a safe, locked place until the completion of the procedure.

These may include Earrings; Bracelets; Necklaces; Rings.

5) Always cover exposed skin abrasions with a waterproof dressing.

6) Never mouth pipette in any laboratory area.

7) Never lick labels in any laboratory area.

2. Gloves:

a. Always use disposable gloves when handling human material.

b. Wearing two pairs of gloves will reduce the risk of skin contact but should be

performed on an ad hoc basis where instrument handling sensitivity is not

compromised.

c. Replace gloves as soon as they become visibly soiled, torn or punctured.

d. Gloves that have been used in the handling of human material must be discarded

before handling anything outside the designated area.

e. Used gloves must be disposed of safely into yellow bags.

f. Latex and hypoallergenic gloves are available in all designated Human Tissue

Handling and non-designated laboratories.

3. Laboratory Coats:

a. Long-sleeved Howie-type coats must always be worn when handling human samples.

b. These are stored in, or adjacent to, designated Human Tissue Handling laboratories.

c. Non-protective garment sleeves should not protrude beyond the cuffs of the coat.

4. Aprons:

a. Plastic aprons must also be worn when homogenising human material.

b. These are stored in designated laboratories.

c. Aprons must be discarded before handling anything outside the safety cabinet.

d. Aprons must be discarded before leaving designated laboratories.

5. Facial barrier protection

32

e. These must be used whenever i) splashes; ii) sprays; iii) droplets; iv) aerosols may

be generated.

f. Available types include i) chin-length face shields; ii) masks; iii) hood sashes

Environmental contamination control

1) During the work full attention must be given to the control of splashing and contamination of

the bench area and care must be taken to avoid the transfer of human material to equipment and

surfaces.

2) These must, as a matter of course, be disinfected as soon as possible after use and immediately

if contamination is suspected.

3) Using fresh gloves, the specimen handling area must be washed down thoroughly with freshly

prepared disinfectant using disposable paper towels.

4) Dispose of these safely (see relevant sections under ‘Disposal/Decontamination and

‘Disinfectants’).

5) If a leaking or broken specimen arrives, do not touch it or any others on which it has leaked.

a) Ask a senior member of staff to deal with it.

6) Leaking specimens must be sent for immediate safe disposal. Exceptions to this are;

a) When it is not possible to obtain a repeat it may be necessary to rescue the material.

b) When it is impracticable to obtain a repeat it may be necessary to rescue the material.

c) Specimen rescue must be attempted only on the authority of senior staff.

Safety cabinets

Chemical fume hoods are designed for working with chemicals that produce fumes. Air enters

through the front opening of the hood and exits through an exhaust duct without being filtered. A

chemical fume hoods protect the worker but not the product or the environment.

A microbiological safety cabinet is defined as a cabinet intended to offer some protection to the

user and the environment from the hazards of handling infected material and other dangerous

biological material but excluding radioactive, toxic and corrosive substances, any air discharged to

the atmosphere being filtered.

A Class I cabinet is an open-fronted exhaust protective cabinet, which can be used for all except

Hazard Group 4 pathogens. Potentially infectious airborne particles will be contained within the

cabinet and retained by impaction on a filter. Put simply the Class 1 cabinet protects the worker but

not the product. The cabinet must exhaust through a HEPA filter to the outside air. Regular

maintenance and performance checks will help to ensure against mechanical faults and

substandard performance.

A Class II cabinet is the most common safety cabinet found in clinical laboratories. In a Class II

cabinet air enters the cabinet, mixes with filtered cabinet air, and passes through intake grilles at

the front of the cabinet. The air mixture is drawn up in an enclosed area (the plenum) behind the

work space to the top of the cabinet. Seventy percent of the air mixture is pushed through the

high-efficiency particulate air (HEPA) supply filters into the cabinet work area; the remaining

30% of the mixture is pushed through the exhaust HEPA filters. Class II cabinets protect the

worker, the product, and the environment from contamination. Class II cabinets are not suitable for

33

working with chemicals.

A Class III cabinet is used when dealing with highly infectious agents.

1. All procedures involving handling human material where aerosols may be generated (e.g.

during vigorous shaking, mixing, homogenisation or ultrasonic disruption) must be performed

in Cat II biological safety cabinets (located in cell culture lab, Keele Building).

2 The area must be cleared of any unnecessary equipment before work starts.

a. Apparatus and material in use in the cabinet during its operation must be kept to a

minimum and placed so as not to disrupt airflows (check with anemometer if additional

equipment is placed in the cabinet).

3 Access of unauthorised persons to the proximity of the work must be controlled to ensure that

the person carrying out the work is free from interruption or accidental contact with others, and

that disturbance of the airflow from the safety cabinet is minimised.

4 The cabinet must never be used unless the fan is switched on and the airflow indicator is in the

safe position after a five minute "warm up" period.

5 Check the airflow monthly with vane anemometer. Record the values of five positions in

record book/on record sheet and initial (see record book/chart for positions).

6 The openable glass viewing panel must not be raised when work is in progress in the cabinet.

7 Centrifuges must never be placed in Class l cabinets.

8 All work must be performed well inside the cabinet and be in sight through the glass screen. In

Class 1 cabinets larger items must be placed towards the rear.

9 A bunsen burner or other naked flame must not be used in the cabinet. The heat generated may

distort the airflow and the filters may be damaged.

10 The cabinet fan must be run at least five minutes after completion of work in the cabinet.

11 After a working session;

a. The working surfaces must be wiped with a disinfectant.

b. The wire grids protecting the prefilters must be examined and wiped clean with a

disinfectant-soaked cloth. Grids and filters can become heavily loaded with dust

without significantly affecting the airflow, but if such particles are dislodged they may

prevent a hazard.

During maintenance of safety cabinets (which includes outside contractors) a notice must be

attached to the front of the cabinet prohibiting its use. All staff must also be informed of scheduled

maintenance at least two week in advance.

Leakages

1. In the event that a container used to transport a Human Tissue Sample is found to be leaking

the leak should first be minimized by placing the sample onto/into either a large plastic tray or

large plastic beaker. Glass beakers should not be used to minimize breakage risk.

2. Prevent access to others and maintain control of the contaminated area.

3. Seek the advice of the Safety Officer or deputy before trying to recover leaking or broken

specimens.

4. In the event that it is suspected leakage may have occurred on route;

a. Couriers, if used, must be notified immediately.

b. Representatives at the site of origin must be notified.

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c. If sample has been delivered by hand from a local laboratory the route of delivery must be

retraced and potential leakage sites cleared and decontaminated.

5. Then;

a. Follow procedures outlined for Spillages were major leaks have occurred which are readily

visible.

b. Once major leaks have been absorbed and removed then decontaminate the entire area

where potential leaks may have occurred.

6) Leaking specimens must be sent for immediate safe disposal. Exceptions to this are;

a. When it is not possible to obtain a repeat it may be necessary to rescue the material.

b. When it is impracticable to obtain a repeat it may be necessary to rescue the material.

c. Specimen rescue must be attempted only on the authority of senior staff.

7) All leakages of Human Tissue Act designated Relevant Material must be reported as an adverse

event at reception. After reporting the event at reception the Designated Individual (Professor

Alicia El Haj) and/or the Human Tissue Officer (Dr Nicholas R Forsyth) must also be notified.

Leaking Sample Recovery Protocol

1) Place container or specimen on a containment tray and take to a safety cabinet.

2) Remove lid or cap and transfer the remaining part of the specimen to another container.

3) Replace cap and place soiled container in a plastic bag and leave it on the tray.

4) If the request form is soiled, place it in another plastic bag and put the bag on the tray so that

somebody else can copy the information.

When dealing with contaminated request forms/lab books/other paperwork

i. Wear disposable gloves

ii. Dictate information on form/paper/etc to colleague who will complete a new form

iii. Discard the contaminated paper into an infected waste container

5) Transfer the plastic bags containing the broken/leaking container and form into an appropriate

container for disposal and disinfect the tray.

6) Finally, disinfect or sterilise the tray or container in which the affected specimen(s) arrived in

the laboratory.

7) Begin processing Human Tissue Sample according to relevant Standard Operating Procedure.

Breakages

1) In the event of a specimen container breakage first action is do not touch it or clear up the mess.

2) Second action is to prevent access to potentially contaminated area.

3) Then;

a) Stay with the specimen to prevent other people touching it.

b) Ask for help from senior staff.

c) If senior staff is unavailable prevent access to contaminated area and seek help.

d) Report the incident to your supervisor as soon as possible.

4) Once the above steps have been performed the Standard Operating Procedure to

decontaminate and recover a breakage site is to;

a) Cover with an absorbent paper towel and soak in 10% hypochlorite solution.

b) Leave for 30 minutes.

c) Remove towel and any broken items into a metal container using forceps and wearing

rubber gloves.

d) The container and its contents must then be autoclaved.

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Major Spillages

In the event of a major spillage:-

1) GET HELP Inform your Supervisor who will in turn inform the Safety Officer or his Deputy. The Safety

Officer will decide whether to operate the information cascade system.

2) DO NOT ATTEMPT TO DEAL WITH THE SITUATION ALONE. 3) The Safety Officer or his Deputy will;

a) Seal the area.

b) Identify the hazard/hazards.

c) Carry out an immediate risk assessment having due regard for:

i) Whether the building needs to be evacuated.

ii) Whether expert help and advice is required.

d) Advise staff who may have become contaminated.

e) Advise and co-ordinate the decontamination procedure having due regard for:

i) The level of personal protective equipment needed.

ii) The appropriate disinfection method required.

f) The Safety Officer having consulted with the Head of Department and others as

appropriate will decide when the area can be reopened.

Small Spillages

1) In the event of a specimen spillage first action is do not touch it or clear up the mess.

2) Second action is to prevent access to potentially contaminated area.

3) Third action is to remove potentially contaminated protective garments and replace with new

ones.

4) Then;

a. Stay with the specimen to prevent other people touching it.

b. Ask for help from senior staff.

c. If senior staff is unavailable prevent access to contaminated area and seek help.

d. Report the incident to your supervisor as soon as possible.

5) Once the above steps have been performed the Standard Operating Procedure to decontaminate

and recover a spillage site is to;

a) Ensure that persons involved in clearing spillage all wear gloves and goggles.

b) Cover spillage with spillage granules.

i) Spillage granules will absorb up to 100% of their weight.

ii) Spillage granules are stored in, or immediately adjacent to designated handling areas.

c) Once granules have absorbed spillage use the provided disposable brush and pan to collect

and clear granules into an autoclave bag.

d) Check with a senior member of staff over suitability of spillage liquid for autoclaving.

Record Keeping

1. Ensure that all samples received are comprehensively labeled from source. Details should

include;

a. Time of isolation.

b. Place of isolation

c. Tissue type.

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d. Tissue treatment post-isolation. For instance;

i. Stored on ice.

ii. Snap frozen in liquid nitrogen.

iii. Stored in fridge at 4oC.

iv. Stored in freezer at -20oC.

v. Washed in PBS, water etc.

2. Make sure that you clearly understand the labelling and hazard warning labels used on

specimens. If unclear contact source for clarification before proceeding with handling.

3. Tissue sample labelling should be recorded as presented in the Institute Tissue Sample Log

Book.

4. Electronic label printing systems or clear print should be utilized for all samples kept

within the Institute for Science and Technology in Medicine.

Packaging and transporting Human Tissue Samples

Local laboratories

1. Transportation of human material between laboratories must be performed using suitable

breakproof and spillproof containers.

2. Local transfer by vehicles other than UHNS courier;

a. this must be performed only when it is either inappropriate or impractical to use

UHNS courier through;

i. Immediacy.

ii. Unsociable hours.

iii. UHNS courier unavailability.

3. Local vehicular transfer must only be performed using approved crash-proof packaging

and a properly insured vehicle.

4. Local vehicular transfer must only be undertaken with the approval of senior staff.

Courier

University Hospital of North Staffordshire

1. Within the environment of the UHNS Tissue samples must be transported by the UHNS

courier service when;

a. Tissue Samples require vehicular transport on UHNS roads.

b. Tissue Samples transportation requires use of public roads.

2. Transfer of samples by the UHNS courier service must only be undertaken with the

approval of senior staff.

Import and export

1) The import (and export) of Human Samples defined as Relevant Material (Human Tissue Act

2004) must be through authorized shipping agents (Keele commonly uses DHL).

2) Human Samples being imported must come from sources which the importer is satisfied are

operating and obtaining in an ethical manner with informed consent.

3) The export of Human Samples must only occur if approvals to export are obtained during the

Informed Consent process of Ethical Approval.

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4) The export of other Relevant Materials (Human Tissue Act 2004) must only occur with

approval of the relevant authorities i.e. UKSCB, Senior Staff Member.

Record keeping

1) All records relating to transport of Human Samples must be maintained by the Chief/Principal

Investigator of the associated study.

(2) It is the responsibility of the Chief/Principal Investigator to ensure that these records are

maintained in a clear and legible manner.

(3) All records relating to transport of Human Samples must be maintained by the Chief/Principal

Investigator of the associated study in a secure and safe environment.

Disposal of Human Tissue Samples and Associated Materials and Decontamination

Procedures

Disposal/Decontamination routes

1. Paper waste bins (black bin liners)

2. Clinical waste bins (yellow, labelled bin liners) for incineration

3. Autoclaving

4. Sharps bin followed by incineration

5. Disinfection

6. Disinfection followed by autoclaving

7. Waste solvent bottles

Disinfection Procedure

Disinfection of samples/materials associated with Human Tissue should be decontaminated with

1% Virkon solution overnight.

Human Tissue Sample Disposal

On completion of any procedure, sample bottles and any remaining sample from the patient

(including red cells, urine, etc.) must be first decontaminated in 1% Virkon Solution.

Decontaminated Samples can then be yellow-bagged and treated as clinical waste.

Disposal of Associated Materials

1 Disposable gloves: Clinical waste bins (yellow, labelled bin liners) for incineration.

2 Plastic aprons: Clinical waste bins (yellow, labelled bin liners) for incineration.

3 Disposable Plastics (tubes, pipette tips, culture flasks, etc): Decontaminated then Clinical

waste bins (yellow, labelled bin liners) for incineration.

4 Disposable Glassware: Decontaminated then Clinical waste bins (yellow, labelled bin liners)

for incineration.

5 Sharps (needles, scalpel blades, etc): Sharps bin followed by incineration.

6 Blood sample bottles: Decontamination then Clinical waste bins (yellow, labelled bin liners)

for incineration.

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7 Excess human material (tissue, blood, etc): Decontamination then Clinical waste bins (yellow,

labelled bin liners) for incineration.

8 Contaminated bench wipes, paper tissues & other disposable paper: Clinical waste bins

(yellow, labelled bin liners) for incineration

9 Contaminated equipment

i) Re-usable equipment (e.g. homogenisers, scalpel blade holders, scissors, pipettes).

Disinfection and autoclaving if possible. If not then one or other.

ii) Safety cabinets: Disinfection

iii) Contaminated lab coats, freezer gloves: Autoclaving followed by laundry (if possible).

iv) Re-usable glassware: Disinfection and autoclaving if possible. If not then one or other.

10 Bench tops: Disinfection.

11 Contaminated solutions: Disinfection and autoclaving.

12 Solvents (e.g. phenol/chloroform/isoamyl alcohol): Waste solvent bottles.

Equipment decontamination

Centrifuge Decontamination

1) Routine Procedure

g. Whenever sample containing human material must be centrifuged in sealed

centrifuge buckets, preferably with ‘see-through’ tops.

h. Always balance containers and buckets. (Centrifuge buckets and trunions must be

paired by weight)

i. The centrifuge must be inspected after each run for signs of spillage.

j. The centrifuge must be inspected weekly for signs of wear

defects/corrosion/cracks. Also check trunions and buckets are lubricated so they

swing freely.

k. Centrifuge buckets may be routinely autoclaved weekly.

l. Centrifuge bowls are routinely cleaned weekly.

i. Gloves must be worn.

ii. Disinfection with 70% isopropanol.

iii. Wipe off with damp swab, then dry.

iv. Discard all swabs into autoclave waste.

g) Disposable gloves are used for ALL cleaning operations.

h) Never use centrifuges inside safety cabinet.

2) Suspected breakage inside sealed buckets of centrifuge

a) Always discuss with senior staff before attempting to salvage leaked specimens.

b) Wear gloves.

c) Remove bucket to safety cabinet before opening.

d) Disinfectant or autoclave bucket and lid.

e) In the event of a known spillage/breakage within the sealed bucket, this should be removed

and autoclaved immediately.

3) Breakages outside sealed buckets

a) Evacuate the room and leave for at least 2 hrs (to reduce aerosol risk).

b) Inform senior member of staff.

c) A designated senior staff member, wearing appropriate protective clothing (gloves, Howie

coat, face mask) will proceed with the disinfection protocol.

39

d) Turn off centrifuge at mains.

e) Remove any broken glass with thick gloves, forceps or swabs and dispose of safely.

f) If possible remove inside bowl to fume-cupboard preferably at the end of the day.

g) Thoroughly disinfect the bowl and lid with a phenolic disinfectant (metal parts) of

hypochlorite solution (other sections) leave for 10 minutes. Wash and wipe with water.

Allow to dry.

h) Buckets are recovered for disinfection or autoclaved (see above).

i) If glutaraldehyde is required, this must only be used by designated personnel under

surveillance by the Occupational Health Department (Consult senior staff).

Class I Protective Cabinet Decontamination

This is essential prior to Cabinet maintenance.

The use of formalin vapour is restricted to the decontamination of exhaust protective cabinets prior

to any maintenance procedures. This must only be performed by designated personnel under

surveillance by the Occupational Health Department (Consult senior staff).

We are currently using a portable formalin vaporiser unit which incorporates two chemical bowls

(Paraformaldehyde bowl and Ammonium Carbonate bowl) and two water bowls. The

Paraformaldehyde is first vaporised into Formalin and the cabinet disinfected. The Ammonium

Carbonate is then vaporised and acts to neutralise the Formalin vapour.

1. Put the gas generator unit inside the cabinet and the control box outside.

2. Put the paraformaldehyde 11.5 g into bowl C1 (top left) and the ammonium carbonate 14.6 g

into C2 (top right).

3. Put 100 mL of water into each of the other bowls.

4. Close up the cabinet and seal off with tape.

5. Power on and leave to run. Leave room.

6. Return after 3-4 hrs.

7. Remove tape, power cabinet on, open cabinet, leave to run for 1 hr.

8. Remove vaporizer unit and wipe down with sterile water.

9. Wipe down all cabinet surfaces with sterile water first and then 70% alcohol.

10. Power down cabinet. Remove all detachable working surfaces and clean as described in (9).

11. Replace all parts, clean again.

N.B. labcoats, gloves and facemasks must be worn throughout this procedure.

Class II Protective Cabinet Decontamination

This is essential prior to Cabinet maintenance.

The use of formalin vapour is restricted to the decontamination of exhaust protective cabinets prior

to any maintenance procedures. This must only be performed by designated personnel under

surveillance by the Occupational Health Department (Consult senior staff).

40

We are currently using a portable formalin vaporiser unit which incorporates two chemical bowls

(Paraformaldehyde bowl and Ammonium Carbonate bowl) and two water bowls. The

Paraformaldehyde is first vaporised into Formalin and the cabinet disinfected. The Ammonium

Carbonate is then vaporised and acts to neutralise the Formalin vapour.

1. Put the gas generator unit inside the cabinet and the control box outside.

2. Put the paraformaldehyde 11.5 g into bowl C1 (top left) and the ammonium carbonate 14.6 g

into C2 (top right).

3. Put 100 mL of water into each of the other bowls.

4. Close up the cabinet and seal off with tape.

5. Power on and leave to run. Leave room.

6. Return after 3-4 hrs.

7. Remove tape, power cabinet on, open cabinet, leave to run for 1 hr.

8. Remove vaporizer unit and wipe down with sterile water.

9. Wipe down all cabinet surfaces with sterile water first and then 70% alcohol.

10. Power down cabinet. Remove all detachable working surfaces and clean as described in (9).

11. Replace all parts, clean again.

N.B. labcoats, gloves and facemasks must be worn throughout this procedure.

Record keeping

(1) All records relating to the Disposal of Human Tissue Samples and Associated Materials and

Decontamination Procedures transport of Human Samples must be maintained by the

Chief/Principal Investigator of the associated study.

(2) Human Tissue Samples which are disposed off must be marked as such in the Human Tissue

Log.

(3) It is the responsibility of the Chief/Principal Investigator to ensure that these records are

maintained in a clear and legible manner.

(4) A record of when safety cabinets or other equipments are decontaminated must be maintained

by the Chief/Principal Investigator of the associated study.

(5) All records relating to Disposal of Human Tissue Samples and Associated Materials and

Decontamination Procedures must be maintained by the Chief/Principal Investigator of the

associated study in a secure and safe environment.

Accident Reporting

Accident reporting falls under the jurisdiction of The Reporting of Injuries, Diseases and

Dangerous Occurences Regulations

Reportable accidents under the above regulations include all fatal and major injuries and any that

result in inability to carry out normal work for more than 3 days. Regulation 3(2)(i) is particularly

pertinent to staff in clinical laboratories.

41

In addition, certain dangerous occurrences defined within the Regulations are reportable. Certain

incidents, diseases and dangerous occurrences have by statute to be recorded and reported directly

to the Safety Executive.

As well as conforming to the specific requirements of the Regulations, a record must be kept of all

injuries, diseases and dangerous occurrences which occur in the laboratory or are associated with

the work in the laboratory. The record keeper (Safety Officer) must be fully authorised to follow

up all such incidents or occurrences as necessary and report them to the head of department or

authorised deputy so that suitable action to prevent recurrence can be taken. Appropriate advice

can be found in the Health Services Advisory Committee (HSAC) publication "Guidance on the

recording of accidents and incidents in the health services".

NHS staff are also required to report incidents/accidents with equipment, reagents and other

materials used at work to the Department of Health Defect Centre of the Medical Devices

Directorate.

Accident report forms are obtainable from the Safety Officer. Senior staff must keep one blank

copy in the Accident Report book for their section, and replace it if used.

Note: Action taken as a result of any incident is an opportunity to review working practices and

minimise all risks.

Staff responsible for implementing and updating procedures on Human Tissue Samples

Dr Nicholas R Forsyth

Professor Paul Eggleston

Professor Alicia El Haj

Specific Training available in handling Human Tissue samples

Training will be provided to all personal before the inception of any project involving Relevant

Material as defined by the Human Tissue Act 2004.

An annual refresher course will be provided.

All new staff will receive a copy of the Human Tissue Handling document.

PROCEDURE FOR WORK WITH GENETICALLY MODIFED ORGANISMS

(GMO)

Use of genetically modified organisms

The Institute of Science & Technology in Medicine (Hartshill Campus) currently holds a licence

for Class 1 GMO ONLY, and under no circumstances must class 2, 3 or 4 work be undertaken. If

you are unsure in any way of the classification of the work you are doing or planning, you must

consult with the Genetically Modified Organisms Biological Safety Officer (GMBSO; Dr Alan

42

Richardson) before undertaking or continuing with the work in question.

On beginning employment at Postgraduate Medicine, GMO workers are required to undergo

training as appropriate following discussions of the proposed work with the GMBSO. If the

GMBSO is satisfied the researcher in question is competent to undertake the work, they will be

signed off by the GMBSO and the researcher’s supervisor. There will also be an annual GMO

seminar to update GMO training which will be mandatory for all registered GMO workers.

Only GMO work which has had a risk assessment passed by the GMO Committee can be

undertaken. All GMOs must be registered with the GMO Committee prior to acquisition or

creation.

GMOs and GM procedures are also subject to the relevant COSHH regulations and the human

tissue/ radiation regulations where appropriate.

General Rules

1. Work with Genetically Modified Organisms (GMO) in laboratories and hospitals must be

performed under conditions of contained use as directed by the contained use regulations 2000.

It is the law that these regulations are complied with as they have been made under the powers of

the Health and Safety at work act 1974 and the European Communities act 1972. A guide to the

Contained Use Regulations 2000 is available for consultation from the GMOSC secretary or the

GMBSO.

These local rules have been drawn up by the School of Medicine/ Institute for Science &

Technology in Medicine (Hartshill Campus) GMO Safety Committee (GMOSC). The purpose

of these local rules is to provide a simple outline of what is required from staff working with

GMOs in order to comply with the Government legislation. Any person found in breach of the

local rules will be subject to disciplinary procedures. The GMOSC has been advised by the

University and the Trust that this person will not receive the support of the parent institution.

2. All proposed work with GMOs must be approved by the GMOSC.

This is achieved by performing a risk assessment on the proposed procedure and presenting this

to the GMOSC for approval. Work can only commence on approval of the risk assessment by

the GMOSC. Guidance on performing risk assessments is available from the Compendium of

Guidance from the ACGM (referred to as the Compendium) at:

http://www.hse.gov.uklhthdir/noframes/acgmcomp!acgmcomp.htm

Risk assessments must be performed on the standard School of Post Graduate Medicine GMO

risk assessment form, these forms and a hard copy of the compendium are available from the

GMBSO and GMOSC Secretary).

3. Staff will only be permitted to work with GMOs;

a) Once they have received ‘in house’ training on the requirements of these local rules

from the GMBSO.

b) On demonstrating good laboratory practice and microbiology/ tissue culture

techniques. The provision of this basic training is the responsibility of the group

supervisor who will subsequently be responsible for that individual in the laboratory.

43

It is important that before an individual works with GMOs that they have “registered”

with their supervisor and the GMBSO by completing the appropriate form

(available from the GMBSO or research secretary). Copies of this must be retained by

the investigator, supervisor and the GMOSC.

3.1 At all times staff must work to the level of containment that is required by the class of

GMO determined in the risk assessment. Examples of levels of containment required for

small-scale work with GMOs of different classes are available in the Compendium and the

Advisory Committee on Dangerous Pathogens (ADCP) manual ‘Categorisation of

biological agents according to hazard and categories of containment (4th edition 1995)’

3.2 Laboratories where work with GMOs is taking place must be clearly labelled and a

summary of the requirements for staff working with GMOs displayed (see end of this

section).

3.3 When requested Staff must be willing to submit to the appropriate health surveillance by

the University Occupational Health Department.

Waste Disposal Spillages

All GMO waste must be inactivated by a validated means according to guidance in the ACGM

compendium and the ACDP manual.

1.1 The most favoured method of disposal of GMO waste is through heat inactivation by

autoclaving. Solid waste (plastics/ agar etc) and small liquid volumes (30m1 universals)

should be placed in labelled double autoclave bags/ or special autoclave jars provided.

Large volumes of liquid waste (>50mls of bacterial supernatant) should be autoclaved in

Pyrex containers. The waste should be clearly labelled GMO School of Postgraduate

Medicine.

1.2 Autoclaving is carried out in the Microbiology Department in the Central Pathology

Laboratories. Validation of inactivation is routinely performed by this department. Waste

should be transported in a sealed autoclave bin and delivered to the autoclave suite via the

lift situated behind the building. The waste must be delivered to Mr Chris Bennett (or Mr

Michael Mackey) in the autoclave suite, on receipt; a log of the waste must be signed.

Waste must not be left without signing the form. Autoclave bins should be left and a new

one taken from Microbiology. Containers to be returned after autoclaving should be clearly

labelled.

1.3 Inactivation of GMOs by a chemical disinfectant is suitable only by a validated means.

Thus, glassware, plastic pipettes, culture waste supernatent can be disinfected in a phenolic

(e.g. Hycolin) a hypochlorite (e.g.Chloros) or a peroxygen compound (Virkon). In the

compendium acceptable levels of kill are 99.9%. Disinfectants commonly used are listed in

the Compendium (Part 3A annex III). The manufacturer’s guidelines are acceptable if they

provide validation, otherwise this must be provided by the investigator. Once disinfected,

plastics can then be incinerated through the normal disposal route

44

1.4 Spillages should be disinfected immediately. Spillages in machinery that could corrode

should be treated with 70% ethanol or 60% isopropanol.

1.5 All accidents involving personnel working with GMOs should be reported and recorded in

accordance with the Schools general Health and Safety policy.

Acquisition and Storage of GMOs

1.1 All GMOs stored in the Institute must be registered with the GMOSC. This is achieved

partly through acceptance of the risk assessment by the committee; however each group is

required to provide an inventory of GMOs currently being stored. This inventory must be

kept up to date as audits will be performed and a central database maintained by the

GMOSC. A template database is available from the GMOSC.

1.2 GMOs stored must be clearly identifiable with the GMO name, classification (risk

assessment number), date of storage and the name of the research group. The box

containing the GMOs must also be labelled and the storage system (fridge /freezer etc)

must also be identified as containing GMOs.

Acquisition of GMOs from outside of the Institute must be performed through completion of an

acquisition form, which then must be authorised by the GMBSO. GMO Acquisition forms are

available for the 0MB SO and the GMOSC Secretary.

Identification of GMO labs (from 1.4). The following notice should be displayed:

WORK WITH GENETICALLY MODIFIED ORGANISMS

WORK WITH GENETICALLY MODIFIED ORGANISMS IS PERFORMED IN THIS

LABORATORY. ALL STAFF MUST BE AWARE THAT BEFORE WORKING WITH GMOs

THE FOLLOWING RULES APPLY:

1) THE INDIVIDUAL PEFORMING THE WORK MUST BE REGISTERED WITH THE

SCHOOL OF MEDICINE/ISTM GMO SAFETY COMMITTEE.

2) THE WORK UNDERTAKEN MUST BE IN COMPLIANCE WITH THE SCHOOL OF

MEDICINE/ISTM LOCAL RULES FOR WORK WITH GMOs.