Human Tissue Handling – Health and Safety
The Guy Hilton Research Laboratories
Keele University Medical School (Hartshill Campus)
Thornburrow Drive, Hartshill
Stoke on Trent ST4 7QB
The Huxley Building
Keele University
Keele
Newcastle-under-Lyme ST5 5BG
The Mackay Building
Keele University
Keele
Newcastle-under-Lyme ST5 5BG
Human Tissue Handling – Health and Safety ..................................................................... 1
Human Tissues in the Laboratory ....................................................................................... 4
General guidelines .......................................................................................................... 4
Risk assessments ............................................................................................................. 5
Definitions................................................................................................................... 5
General ........................................................................................................................ 6
Performing a risk assessment ...................................................................................... 7
Training requirements for handling ................................................................................ 8
Acquiring Human Samples ................................................................................................. 9
Human Tissue Samples ................................................................................................... 9
NRES Route ................................................................................................................ 9
Consent Route ........................................................................................................... 11
Human Stem/Primary Cell Samples ............................................................................. 12
Other sources ............................................................................................................ 13
Material Transfer Agreements ...................................................................................... 14
Other agreements .......................................................................................................... 15
Record Keeping ............................................................................................................ 16
Handling Human Tissue Samples ..................................................................................... 17
Designated laboratories ................................................................................................. 17
Techniques .................................................................................................................... 18
Protective Equipment .................................................................................................... 19
Generic ...................................................................................................................... 19
Personal ..................................................................................................................... 20
Environmental contamination control........................................................................... 21
Safety cabinets .......................................................................................................... 22
Leakages ................................................................................................................... 24
Leaking Sample Recovery Protocol...................................................................... 25
Breakages .................................................................................................................. 26
Major Spillages ......................................................................................................... 27
Small Spillages.......................................................................................................... 27
Record Keeping ............................................................................................................ 28
Packaging and transporting Human Tissue Samples ........................................................ 29
Local laboratories.......................................................................................................... 29
Courier .......................................................................................................................... 30
University Hospital of North Staffordshire............................................................... 30
Third party ................................................................................................................ 31
Import and export .......................................................................................................... 32
Record keeping ............................................................................................................. 33
Disposal of Human Tissue Samples and Associated Materials and Decontamination
Procedures ......................................................................................................................... 34
Disposal/Decontamination routes ................................................................................. 34
Disinfection Procedure.................................................................................................. 35
Human Tissue Sample Disposal ................................................................................... 36
Disposal of Associated Materials.................................................................................. 37
Equipment decontamination ......................................................................................... 39
2
Centrifuge Decontamination ..................................................................................... 39
Class I Protective Cabinet Decontamination ............................................................ 40
Class II Protective Cabinet Decontamination ........................................................... 41
Record keeping ................................................................................................................. 42
Accident Reporting ........................................................................................................... 43
Complaints Policy ............................................................................................................. 44
Governance Policy ............................................................................................................ 45
Staff responsible for implementing and updating procedures on Human Tissue Samples46
Specific Training available in handling Human Tissue samples ...................................... 47
The ISTM Human Tissue Committee reference and membership. .................................. 48
Associated Documents ...................................................................................................... 50
Risk Assessment form for activities involving biological agents ................................. 51
COSHH assessment: Institute of Science & Technology in Medicine ......................... 64
Research Protocol Outline Form ................................................................................... 66
3
Human Tissues in the Laboratory
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 (see Page 17).
7. Only designated area are to be used for the storage of samples of human material (see
Page 17).
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. The biological risk
assessment form and all associated Appendices are located on Page 51 –Page 63. The
ISTM COSHH form is located on Page 64 – Page 65.
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).
4
Risk assessments
Definitions
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
4) Risk assessments should be suitable and sufficient such that appropriate levels of
depth, control and monitoring are applied.
5
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.
6
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.
7
Training requirements for handling
1. Only staff that has 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 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.
8
Acquiring Human Samples
Human Tissue 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
Keele University contact: Nicola Leighton, Research Governance Officer, Office of
research and Enterprise, Dorothy Hodgkin Building, Room DH1:13, Keele university,
staffs, ST5 5BG. Tel 01782 583306, e-mail n.leighton@uso.keele.ac.uk
University Hospital North Staffordshire contact: Dr Darren Clements, R&D manager
(UHNS), North Staffordshire Medical institute, Hartshill Road, Stoke-on-Trent, Staffs,
ST4 7NY. Tel 01782 554 839, e-mail darren.clement@uhns.nhs.uk
The IPR form is located from Page 66-73 Page of this document. Advice on completion
of this form should be sought from the individuals named above.
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.
N.B. Where a research project has LREC approval it is not within the remit of the Human
Tissue Act. Furthermore where any study has started within 2 years of its approval date it
is not a requirement to apply for an extension of the approval period. The approving
LREC should be receiving annual progress reports including an explanation of why the
study is going to take longer to complete than was originally estimated.
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
9
Chief Investigator will not have accompanying Consent documentation and covering
material from the Bank will suffice in this instance.
10
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).
11
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 Guy Hilton Research Centre.
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.
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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.
13
Material Transfer Agreements
All Material Transfer Agreements (MTA), Materials Use Licenses (MUL) or
Memorandum of Understanding (MOU) must be undertaken through and with the
guidance of the Office of Research and Enterprise (http://www.keele.ac.uk/research/) at
Keele University. Full Contact details are below;
Research and Enterprise Services
Dorothy Hodgkin Building
Keele University
Staffordshire
ST5 5BG
Tel +44 (0)1782 583371
Fax +44 (0)1782 583740
14
Other agreements
All other agreements must be undertaken through and with the guidance of the Office of
Research and Enterprise (http://www.keele.ac.uk/research/) at Keele University. Full
Contact details are below;
Research and Enterprise Services
Dorothy Hodgkin Building
Keele University
Staffordshire
ST5 5BG
Tel +44 (0)1782 583371
Fax +44 (0)1782 583740
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Record Keeping
1) 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.
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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;
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, note these labs are currently under refurbishment); and rooms 1/015 (Clean Utility),
1/016 (Laser Lab), 1/017 (SIFT lab), 1/019 (Incubator Room), 2/001 (Molecular Lab),
2/002 (Histology), 2/006 (Biomaterials), 2/010 (Magnetics), 2/011 (Microwave Lab),
2/014 (CT Scanner), and the Cell Therapy Suites.
Huxley – Rm.152b, Rm.152c, Rm.152d, Rm.155b, Rm.206, Rm.311, Haldane
laboratories
Mackay – 120, 122, 123, 125, DT3, DT4
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. These are located in;
GHRC - . labs 2, 4, 6, 8, 11, and 13 (Medical Research Unit); and rooms 1/017 (SIFT
lab), 1/019 (Incubator Room), 2/001 (Molecular Lab), 2/002 (Histology), 2/006
(Biomaterials), 2/010 (Magnetics), and the Cell Therapy Suites.
Huxley – Rm.152b, Rm.152c, Rm.155b, Rm.206, Rm.311
Mackay – DT3
7) All other aspects of the procedure should be performed in a fume hood or other
suitable sterile area.
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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.
a. 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 the become, or 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 are properly protected
and accidental self-inoculation and splashing of mucous membranes be
avoided.
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.
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Protective Equipment
Personal protective equipment (PPEs) 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:
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;
a) Earrings
b) Bracelets
c) Necklaces
d) 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.
19
Personal
1 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.
2 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.
3 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.
4 Facial barrier protection
a. These must be used whenever;
i. splashes
ii. sprays
iii. droplets
iv. aerosols
v. may be generated.
b. Available types include
i. chin-length face shields
ii. masks
iii. hood sashes
c. Face Barrier protection is stored in designated laboratories.
d. Note that opening some containers may create aerosols.
20
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.
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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 (British Standard 5726: l979 revision in preparation). E.g. HEPAIRE BS5726 l979 CLASS l cabinets.
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 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 labs K10 and K12, 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.
22
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.
23
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.
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.
24
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.
a. 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.
25
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.
i) 10% hypochlorite solution is available in all designated handling areas.
b) Leave for 30 minutes.
c) Remove towel and any broken items into a metal container using forceps and
wearing rubber gloves.
i) Autoclavable containers are available in all designated handling areas.
d) The container and its contents must then be autoclaved.
26
Major Spillages
In the event of a major spillage:1) GET HELP
a. 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.
27
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.
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.
a. 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.
28
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.
29
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.
30
Third party
1. Use of third party courier services must only be undertaken with the approval of
senior staff.
31
Import and export
1) The import 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.
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.
32
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.
33
Disposal of Human Tissue Samples and Associated Materials and Decontamination
Procedures
Disposal/Decontamination routes
1.
2.
3.
4.
5.
6.
7.
Paper waste bins (black bin liners)
Clinical waste bins (yellow, labelled bin liners) for incineration
Autoclaving
Sharps bin followed by incineration
Disinfection
Disinfection followed by autoclaving
Waste solvent bottles
34
Disinfection Procedure
Disinfection of samples/materials associated with Human Tissue should be
decontaminated with 1% Virkon solution overnight.
35
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.
36
Disposal of Associated Materials
1 Disposable gloves.
i
Clinical waste bins (yellow, labelled bin liners) for incineration.
2 Plastic aprons.
i
Clinical waste bins (yellow, labelled bin liners) for incineration.
3 Disposable Plastics (tubes, pipette tips, culture flasks, etc).
i
Decontaminated then Clinical waste bins (yellow, labelled bin liners) for
incineration.
4 Disposable Glassware.
i
Decontaminated then Clinical waste bins (yellow, labelled bin liners) for
incineration.
5 Sharps (needles, scalpel blades, etc).
i
Sharps bin followed by incineration.
6 Blood sample bottles.
i
Decontamination then Clinical waste bins (yellow, labelled bin liners) for
incineration.
7 Excess human material (tissue, blood, etc).
i
Decontamination then Clinical waste bins (yellow, labelled bin liners) for
incineration.
8 Contaminated bench wipes, paper tissues & other disposable paper.
i
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.
i
Disinfection.
11 Contaminated solutions.
37
i
Disinfection and autoclaving.
12 Solvents (e.g. phenol/chloroform/isoamyl alcohol).
i
Waste solvent bottles.
38
Equipment decontamination
Centrifuge Decontamination
1) Routine Procedure
a) Whenever sample containing human material must be centrifuged in sealed
centrifuge buckets, preferably with ‘see-through’ tops.
b) Always balance containers and buckets. (Centrifuge buckets and trunions must be
paired by weight)
c) The centrifuge must be inspected after each run for signs of spillage.
d) The centrifuge must be inspected weekly for signs of wear
defects/corrosion/cracks. Also check trunions and buckets are lubricated so they
swing freely.
e) Centrifuge buckets may be routinely autoclaved weekly.
f) 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.
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).
39
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 11.5g into bowl C1 (top left) and the ammonium carbonate
14.6g into C2 (top right).
3. Put 100mls 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 3-4hrs.
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.
40
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).
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 11.5g into bowl C1 (top left) and the ammonium carbonate
14.6g into C2 (top right).
3. Put 100mls 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 3-4hrs.
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.
41
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.
42
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.
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".
N.H.S. 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.
43
Complaints Policy
It is our policy to follow the procedures outlined in the University Hospital of North
Staffordshire document RM02: Policy and Procedures for Handling Complaints. This
document is mounted in the dedicated Human Tissue Act area of the ISTM intranet.
In the event of any complaints arising Dr Nicholas Forsyth (ISTM Human Tissue
Officer) and Dr Darren Clements (UHNS R&D manager) must be notified immediately.
44
Governance Policy
It is our policy to follow the procedures outlined in the Research Governance leaflet
produced by Keele University’s Research Services and the Code of Good Research
Practice. These documents are mounted in the dedicated Human Tissue Act area of the
ISTM intranet. For more information please go to
http://www.keele.ac.uk/research/researchsupport/governance.htm.
It is our policy to also follow the procedures outlined in the University Hospital of North
Staffordshire document G02: Policy on Research Governance. This document is mounted
in the dedicated Human Tissue Act area of the ISTM intranet.
In the event of any issues arising please contact either Nicola Leighton (Research
Governance Officer, Keele University) and/or Dr Darren Clements (UHNS R&D
manager).
45
Staff responsible for implementing and updating procedures on Human Tissue
Samples
Dr Nicholas R Forsyth
Professor Paul Eggleston
Professor Alicia El Haj
46
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.
47
The ISTM Human Tissue Committee reference and membership.
Membership, frequency & reporting
Title: ISTM Human Tissue Committee
Membership: Prof Alicia El Haj – Director of ISTM
Dr Nicholas R Forsyth – Lecturer in Stem Cell Biology, ISTM
Mark E Smith – Research Services Manager, ISTM
Paul Harrison – Principal Clinical Scientist, RJAH
Prof Paul Eggleston - Professor of Molecular Entomology
Dr Darren Clement
Chair: Nicholas R Forsyth
Sub-Groups: Health and Safety Committee
Frequency of Meeting: Twice annually
Receive Reports From: Health and Safety Committee
Human Tissue Authority
User Groups
Provide Reports To: Human Tissue Authority (in form of audit)
Health and Safety Committee
User Groups
Administered by: Dr N. R. Forsyth
Terms of Reference: Attached
Authority: Keele University
48
Terms of Reference: - ISTM Human Tissue Committee
1. To implement, review, and develop the Institutes compliance with the
requirements of the Human Tissue Act 2004.
2. To have general oversight on research activities utilizing Human Tissues
within ISTM.
3. To implement and govern GLP on all research involving Human Tissues.
4. To implement and govern safety procedures on all research involving Human
Tissues.
5. To receive and consider reports from licensing authorities and implement
actions were appropriate.
6. To receive and consider reports detailing safety concerns and implement
actions were appropriate.
49
Associated Documents
50
Risk Assessment form for activities involving biological agents
RISK ASSESMENT NUMBER:
CONTROL OF SUBSTANCES HAZARDOUS TO HEALTH
This form must be completed prior to the commencement of work involving a
biological agent*, in order that a suitable and sufficient assessment of health
risks is made. (*work involving hazardous substances requires separate
assessment)
HELP! Where a  appears, clicking on a data entry box, or on the arrow of a pulldown menu, and pressing F1 will reveal any help available.
PART 1
Date of assessment:
Process/Activity:
51
PART 2
INFORMATION GATHERING FOR BIOLOGICAL AGENTS
I. Hazard Identification
NAME OF SAMPLE MATERIAL
HAZARD RATING
OR BIOLOGICAL AGENT(S)
eg LOW (GROUP 1)
1
N/A
2
N/A
3
N/A
4
N/A
5
N/A
6
N/A
Note: Include biological fluids/tissues in the assessment- in assigning a hazard
rating for these the assessor must consider the likelihood of biological agents
being present. If suspected these should be listed and rated accordingly.
II. Exposure Potential
Route(s) by which exposure to the agent is hazardous to health (see Appendix
3):
AGENT(S)
(see above)
1
2
3
4
5
6
EXPOSURE POTENTIAL
(Appendix 3)
N/A
N/A
N/A
N/A
N/A
N/A
HAZARD RATING
N/A
N/A
N/A
N/A
N/A
N/A
52
III. Risk
RISK=HAZARD RATING*EXPOSURE POTENTIAL
AGENT(S)
(see above)
1
2
3
4
5
6
RISK
N/A
N/A
N/A
N/A
N/A
N/A
PART 3
HAZARD REDUCTION
Reducing an initial hazard could reduce the estimated risk. Answer the questions
below (check boxes), if you respond “YES” to any of them complete the sections
“Justify Continued Use” and “Remedial Action”.
QUESTION
YES
NO
JUSTIFY CONTINUED
USE
REMEDIAL
ACTION
Can the use of the
material be avoided?
Can smaller amounts
be used practically?
Are there less
hazardous substitutes?
Any proposed actions may either be checked at review or will be required to be in
place before approval of the assessment is given.
PART 4
CONTROL MEASURES
I. Containment Level
Specify: N/A
Note: Work can be carried out safely on the open bench using good
microbiological practice.
53
II. Engineering Control Measures
The work must be carried out completely in a safety cabinet* 
*Specify location of safety cabinet and class:
The work must be carried out in a specialised containment room*
*Specify location of room and containment level:
The work can be carried out partially on the open bench and partially in a
microbiological safety cabinet*
*Specify which type of enclosure is to be used and what part(s) of the work
activity must be carried out within:
Where engineering controls are used eg. microbiological safety
cabinets, are these subject to a formal performance test, at least Yes
every year, and records kept?
No
III. Personal Protective Equipment (PPE)
Where adequate control of exposure to the hazardous substance(s) cannot be
achieved by substitution or engineering controls therefore the following type(s) of
PPE will be required for part or all of the activity. Note: It is assumed that nonlatex gloves and lab coat will always be worn.
Eye protection
Face protection
Respirator / mask
Other (eg. clothing) (specify)
Specify when during the activity the item(s) of PPE must be worn:
Non-disposable items of PPE must be inspected regularly and records retained for inspection
54
III. Emergency Procedures
Yes
Written emergency instructions are available at the work site(s)
No
Emergency contact details are provided at the work site(s)
Disinfectants for neutralising spills of biological agent(s) are
available
Proper and sufficient spill kits are available
Is the internationally recognised biohazard sign displayed?
If necessary, are specific procedures available for the safe
transport of the agent(s) between laboratories or buildings?
If applicable, will a person with the appropriate expertise be
available to deal with spillages of particularly hazardous biological
agents*
*Specify whom and how they are to be contacted:
The locations of the following are known to the user:
Eye irrigation point
Fire-fighting equipment
First aid box
The user knows how to summon the following personnel:
First aider
External emergency services
IV. Waste Disposal Routes
Disposal/Decontamination of biological agents and contaminated equipment will
be done by:
1.Clinical waste bins (yellow, labelled bin liner)
2.Autoclaving
3.Sharps bin followed by autoclaving
4.Disinfection Virkon
Bleach
Trigene
(tick as appropriate)
5.Disinfection followed by autoclaving
6.Liquid waste storage bottle (subsequent autoclaving when full)
Note: Biological waste should not be disposed of in black bin liners.
55
V. Training
Note: Formal training will be given regarding “Local Rules” that apply to work
with biological agents. A written record of attendance for all users must be
kept.
Users must arrange to attend formal training
Have all users received formal training regarding work with Yes
biological agents?
Have all users received training from supervisor (or delegated
staff)?
No
VI. Supervision
Workers must be aware of who their direct supervisor is for the work (in the
laboratory)
Yes
No
Are all users aware of who will directly supervise the activity?
VII. Implications for Persons Not Involved in the Work Activity
Identify any persons in the following groups, not directly involved with the work
activity, who may be at risk from the hazards of the activity.
Academic staff
Undergraduat
es
Cleaning staff
Visitors
Technical staff
Maintenance staff
Postgraduates
Secretaries
Emergency
personnel
Others
Contractors
Persons identified above may need to be informed, in part or in full, of the information contained
in this risk assessment.
56
VIII. Health Monitoring
Is there potential contact with biological fluids? If yes, Yes
immunisation against Hepatitis is necessary*.
Is an effective vaccine or other prophylaxis available/necessary
for the work?
If yes, specify requirements/arrangements:
No
*This should be arranged via the Occupational Health Service in the Department
of Occupational Health and Safety.
IX. Instructions for the Work Activity
All laboratory activities require precise written procedures (Standard Operating Procedure-SOP).
A SOP form should be completed using information from this (and any other) risk assessment.
A SOP has been completed and is attached
(reference no)
X. Repeat Risk Score Assessment
This time include control measures as determined in Part 4.
I. Exposure Potential
Route(s) by which exposure to the agent is hazardous to health (see Appendix
3):
AGENT(S)
(see above)
1
2
3
4
5
6
REVISED EXPOSURE POTENTIAL
(Appendix 3)
N/A
N/A
N/A
N/A
N/A
N/A
HAZARD RATING
N/A
N/A
N/A
N/A
N/A
N/A
57
II. RISK
RISK=HAZARD RATING*EXPOSURE POTENTIAL
AGENT(S)
(see above)
1
2
3
4
5
6
ORIGINAL RISK
REVISED RISK
N/A
N/A
N/A
N/A
N/A
N/A
XI. Accreditation and Verification of Assessment
The completed assessment must be signed and dated by the person making the
assessment and then checked and signed by the senior person with
responsibility for the area in which the activity is to be undertaken.
Assessor:
Name
Verifier
:
Name
____________________Date
Signed
____________________Date
Signed
An electronic copy of the assessment should be returned to the Workplace Safety Adviser.
The hard copy (with signatures) must be kept readily available where the activity is to be
undertaken.
The assessment must be reviewed at regular intervals and immediately when there is any
change that may affect its validity.
58
APPENDIX 1
Containment levels for work involving human or primate cell cultures.
HAZARD
LOW
MEDIUM
HIGH
V.HIGH
CELL TYPE
Well characterised or authenticated
finite or continuous cell lines of human
or primate origin with a low risk of
endogenous infection with a human
pathogen presenting no apparent
hazard to laboratory workers or to the
environment.
Non-human, non-primate cell lines,
including those of murine origin.
Finite or continuous cell lines/strains of
human or primate origin not fully
authenticated or characterised, except
where there is a high risk of
endogenous pathogens such as blood
borne viruses.
Cell lines with endogenous pathogens
or cells that have been deliberately
infected.
Primary cells from blood, lymphoid cells,
neural tissue of human or simian origin.
CONTAINMENT LEVEL
Containment level 1.
Good microbiological practice
and good occupational safety
and hygiene.
Containment level 2, plus
the use of a class II safety
cabinet.
Containment appropriate to
the agent.
Containment appropriate to
the potential risk.
59
APPENDIX 2
Categorisation of biological agents.
From the Advisory Committee on Dangerous Pathogens (ACDP) categories for
containment (based on their ability to cause infection).
GROUP 1 (LOW Hazard)- A biological agent that is unlikely to cause human disease.
GROUP 2 (MEDIUM Hazard)- A biological agent that can cause human disease
and which might be a hazard to laboratory workers but is unlikely to spread to the
community and effective prophylaxis or effective treatment are usually available.
GROUP 3 (HIGH Hazard)- A biological agent that can cause severe human
disease and present a serious hazard to laboratory workers. It may present a
risk of spread to the community but there is usually effective prophylaxis or
treatment available.
GROUP 4 (V.HIGH Hazard)- A biological agent that causes severe human
disease and is a serious hazard to laboratory workers. It is likely to spread in the
community and there is usually no effective prophylaxis or treatment available.
60
APPENDIX 3
EXPOSURE ROUTES
Route(s) by which exposure to the agent is hazardous to health:
1=Skin, broken; 2=Skin, unbroken;
3=Eye Contact;
4=Inhalation;
5=Injection; 6=Ingestion
EXPOSURE POTENTIAL
SCORE >
(A) Quantity of
biological agent
(B) Number of
hazardous exposure
routes (from above)
(C) Characteristics of
operation (including
primary containmentsee notes below)
1
10
100
< 1 ml fluids
1 sample
1-10 ml fluids
2-10 samples
>10 ml fluids
>10 samples
1
>1
None
Predominantly
enclosed
system,
low chance of
mishap
Partially open
system,
low chance of
mishap
No physical barrier,
any operation where
chance of mishap is
medium or high,
aerosols produced
Notes:
1) Exposure Potential equals the sum of (A), (B), and (C).
2) Time factors, such as frequency and duration of the activity, should also be
considered. Continuous operations on a daily basis should raise the
exposure estimate to the next category.
3) It is important that the evaluation is based only on estimates of potential
exposure arising from the activity itself without additional control measures.
The effect of secondary containment, such as microbiological safety
cabinets, should not be included as this would pre-judge decisions on the
level of containment required.
4) Primary containment is that containment provided by the apparatus or
equipment in which the substance is handled. Secondary containment is the
additional containment needed to ensure appropriate control of exposure.
61
APPENDIX 4
CONTAINMENT LEVELS & REQUIRED LABORATORY FACILITIES
Containment Measures
1. Access is to be restricted to
authorised persons only.
2. Specified disinfection procedures.
3. The workplace is to be maintained at an
air pressure negative to atmosphere
4. Efficient vector control, eg., rodents and
insects.
5. Surfaces impervious to water and easy to
clean. Benches to be cleaned after use.
6. Surfaces resistant to acids, alkalis,
solvents, disinfectants
7. Safe storage of biological agents
8. Infected material, including any animal, is
to be handled in a safety cabinet or isolator
or other suitable containment.
9. Laboratory door to be closed during
activity
10. Laboratory coats to be worn in lab. suite
and removed on exiting
Minimum Containment Levels
1
2
No
Yes
No, but
disinfectants
available
No
Yes, for animal
containment
Yes, for bench
Yes, for bench
Yes
No, unless
mechanically
ventilated
Yes, for animal
containment
Yes, for bench,
regularly
decontaminate
Yes, for bench
No
No, but
procedures
should minimise
aerosols
Yes
Yes
Yes, where
aerosol
produced
Yes
Yes
11. Procedures for storage and maintenance
of protective equipment must be in place
12. Procedures for dealing with
contaminated PPE must be in place
13. Mouth pipetting forbidden
14. Eating, drinking, smoking, food storage,
taking medication, cosmetic application
forbidden
15. Hand wash basin in lab.
Yes
Yes, side or
back fastening
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
16. Material awaiting disinfection to be stored
safely
17. Procedures for safe collection, storage
and disposal of contaminated waste
Yes
Yes, with
hands-free tap
operation
Yes
Yes
Yes
No
Yes
Yes
Yes
18. Contaminated waste must be labelled
before removal for incineration
19. Hands to be decontaminated
immediately and on leaving lab.
62
20. Autoclave available for sterilisation of
waste in the same building
21. Materials for autoclaving should be
transported in robust containers without
spillage
22. Incinerator for disposal of infected animal
carcasses
23. Adequate space for each worker (24m 3)
23. Accidents to be reported
No
Yes
N/A
Yes
No
Accessible
No
Yes
Yes
Yes
Abstracted from ACDP “Categorisation of biological agents according to hazard
and categories of containment” 1995, 4th edn.
63
COSHH assessment: Institute of Science & Technology in Medicine
Title of Experiment/Procedure:
Date of Assessment:
Name of
hazardous
substances to be
used
Names & Status of Worker:
Type of Hazard
Chemical or Biological
Approximate quantity and
the likelihood of exposure,
e.g. high, medium, low
Hazards identified
NOTE: enter skin contact or
absorption, eye contact, inhalation,
injection, ingestion, where relevant.
1.
2.
3.
4.
5.
Overall risk
assessment of the
substances
Very high
category
High
Medium
Low
Carcinogen
1.
2.
3.
4.
5.
Information
source:
64
Control Measures adopted (personal protective equipment)
Biological
Safety Cabinet
Fume cupboard
Safety Goggles
Gloves
Good Ventilation
Face Mask/
Dust mask
If special, state details
Spillage
Gloves
Face
protection
Disinfectant
Spillage kit
Mop up
Mix with
sand
Method of Disposal
Chemical
Waste bottle
Drain
Yellow bag
Autoclave
No hazard
Emergency procedures
In case of fire
In case of water failure
In case of electricity
failure
Emergency contact name
Emergency phone
number
Signatures
Name and signature
Date
Assessor
Supervisor or
COSHH Supervisor
65
Research Protocol Outline Form
(supplement to the LREC form)
The research protocol should be completed as concisely as possible and it should address
the following points as applicable. Please state clearly if any section is not applicable to
your project. The majority of the sections are the same as the LREC form. The boxes
can be expanded and your text can be ‘cut and pasted’ from the LREC form. For
convenience we have indicated the relevant LREC question references that map to this
form.
PLEASE NOTE THAT THE INDEPENDENT PEER REVIEW COMMITTEE IS
NOT LINKED OR A SUB-COMMITTEE OF THE LOCAL RESEARCH ETHICS
COMMITTEE (LREC).
1
STUDY TEAM AND RESEARCH MANAGEMENT (moved from the bottom of
the form)
Name of Principal Investigator (C2 of Ethics form):
Current post:
Contact postal address:
Contact telephone number:
Contact e-mail address:
Other members of the study team (please specify names, current post and their role in
this study) (A66 and C3 of Ethics form):
Name:
Current post:
Organisation:
Role in the study:
Name:
Current post:
Organisation:
Role in the study:
Name:
Current post:
Organisation:
Role in the study:
66
Name:
Current post:
Organisation:
Role in the study:
Name:
Current post:
Organisation:
Role in the study:
If more than 5, please use a separate sheet
Institute/Research Centre/Programme/Department name:
Name of Research Director:
2
PROJECT IDENTIFIER
Full title of research project (A1 of Ethics form):
Key Words:
Short title:
3
WHAT IS THE PRINCIPAL RESEARCH QUESTION/OBJECTIVE?
Provide a clear account
of the purpose of your investigation, including primary and
secondary objectives (A7, A8, A48 and A49 of Ethics form):
4
SCIENTIFIC BACKGROUND. What is the scientific justification for the
research? What is the background? Why is this an area of importance? Has similar
research on this topic been done before? Have all existing sources of evidence, especially
systematic reviews been fully considered? What new information will it provide (A9,
A46 and A47 of Ethics form)? (Should be no longer than 1 A4 page in length).
5
STUDY TYPE
Research methodology (strike through as many as are appropriate)
Randomised controlled trial Yes / No
Controlled trial without randomisation
Yes / No
Case control study
Yes / No
Cross-sectional study Yes / No
Quasi-experimental Yes / No
67
Before and after study Yes / No
Survey Yes / No
Cross-over study
Yes / No
Qualitative
Yes / No
Cohort Yes / No
Observational Yes / No
Other Yes / No
If other, give details:
Is the research being undertaken as part of an educational course or degree? Yes /
No
If YES give details including:
Name and level of course/degree
Name of educational establishment
Name of Supervisor
DETAILED PLAN OF INVESTIGATION
(you may wish to use the following headings as a guide – please use separate sheets of
paper) (Should be no more than 2 A4 pages in length)
Summary of the study (Give a brief synopsis/summary of methods and overview of the
planned research. A flow chart or diagram should be attached where appropriate. It
should be clear exactly what will happen to the research participant, how many times and
in what order) (A10 of Ethics form):
Study population
Inclusion criteria (What inclusion criteria will be used to select participants/patient
records/tissue or bodily samples (list cases and controls separately if appropriate?)) (A22
of Ethics form):
Exclusion criteria (If you are excluding participants on the basis of age, sex or ethnicity
please explain why) (A23 of Ethics form):
Will the study involve the recruitment of human research participants?
No
Yes /
Study Setting (Name and Description of Centres) (A56, C9 and C10 of Ethics form):
How will potential research participants in the study be identified, approached and
recruited? (Give details for cases and controls separately if appropriate, describe
sampling methodology and randomisation procedures) (A20 of Ethics form):
68
Will informed consent be obtained from the research participants?
Yes / No
(Give details of who will obtain consent, how it will be done, and of any particular steps
other than an information sheet taken to provide information e.g. video, interactive
media. Please attach a copy of the consent form. If consent is not to be obtained, please
explain why not) (A26 of Ethics form):
Subject/Patient participation
(Provide details of what research participants will do e.g. treatment intervention,
completion of a questionnaire, participate in an in-depth interview; provide details of how
the research procedures or intervention will be administered (include duration and audit
details); provide details of any risks to the participant and safeguards to be put in place)
(A12 and A13 of Ethics form):
Follow-up (Provide details of follow-up procedures and time points, if appropriate)
Outcome Measures (if appropriate)
Primary Outcome (A48 of Ethics form):
Secondary Outcome (A49 of Ethics form):
DATA ANALYSIS
(include power calculations, if applicable)
Has the size of the study been informed by a formal statistical power calculation?
Yes / No
If YES indicate the basis upon which this was done, covering the areas shown, and giving
sufficient information to allow the replication of the calculation (A51 of Ethics form):
If NO, explain how the size of the study was determined and why a formal sample size
calculation is not required:
Describe methods of analysis (identifying specific procedures in the case of
statistical analysis or analytical methods in the case of qualitative research) (A53 of
Ethics form):
Has a statistician or an advisor for qualitative research given an opinion about the
statistical or methodological aspects and design of the research? (A52 of Ethics
form)
Yes / No
If YES, give the name and contact details:
If NO, then give reason why not:
Where will the analysis of the data from the study take place and by whom will it be
undertaken? (A41 of Ethics form)
69
STUDY TIMETABLE
Start date:
End date:
Duration (Years and Months):
Completion date for data collection:
Proposed reporting/publication dates:
Has funding for this project been secured? Yes / Currently being sought / No*
*Please delete as appropriate
If yes or being sought, where from?
Funding details
This section is covered on the COREC form so the information is no longer
requested by the Peer Review Committee.
EVIDENCE OF SCIENTIFIC REVIEW
(only applications with NO evidence of independent peer review need to be submitted)
DETAILS OF PEER REVIEW REQUIREMENTS
(to be completed by the Principal Investigator)
Name of Funder:
Name of Sponsor:
I confirm that the information submitted in this proposal is complete and correct and this
project will be conducted in accordance with Research Governance requirements
SIGNED …………………………………………………….. (Principal Investigator’s
signature)
70
STATUS of STUDY (please indicate which)
(to be completed by the Principal Investigator)
Student Project
Pre-pilot/Pilot
Full study
study
PROPOSED INDEPENDENT REVIEWERS
(to be completed by the Principal Investigator)
For projects that have not been externally reviewed. Provide names and e-mail
addresses. The Committee member reviewing the project may choose to send the
project to one of your external reviewers, together with an external reviewer of their
own choice.
For student/pilot research projects:Applicants are requested to provide the names of three external reviewers, as for full
projects. These projects will normally only be reviewed by the Board. However, a judgment
will be made by a Committee member if the project requires external peer review.
Name:
E-mail:
Organisation:
Relationship between applicant and reviewer:
2)
Name:
E-mail:
Organisation:
Relationship between applicant and reviewer:
3)
Name:
E-mail:
Organisation:
Relationship between applicant and reviewer:
STUDENT PROJECTS
(Student projects will be normally reviewed by the Board only and a judgment made if they
need to be sent for external review)
Supervisor’s name and institutional
address
Degree type, and institution (if different
from supervisor’s)
Educational value of the project
Potential risks and safeguards
Supervision arrangements
71
I can confirm that this project will be
supervised in line with Research
Governance Requirements
Supervisor signature
…………………………………
Status of Supervisor
………………………………….
Principal Investigator to obtain the authorised signatures
ORGANISATION
ORGANISATION
Having discussed this proposal with
the applicant, I confirm that the
research fits within the scientific
programmes of the University /
NHS Trust
University Institute
Director/Programme
Director/Head of
Department
OR
If it is a joint project between the
University and the NHS Trust, or
involves both the University and
the Trust, signatures must be
obtained from BOTH
organisations.
NHS Trust R&D
Director/Manager or
Research Governance
Manager
I confirm that I have read this
application and agree that if
approved it:
will meet Research Governance
requirements
be accommodated & administered
in the University / NHS Trust
University Institute
Director/Programme
Director/Head of
Department
OR
If it is a joint project between the
University and the NHS Trust, or
involves both the University and
the Trust signatures must be
obtained from BOTH
organisations.
AUTHORISING
SIGNATURE
NHS Trust Clinical
Director/Directorate
Manager or Research
Governance Manager
Once completed and the appropriate signatures have been obtained:If it is a Trust project, please e-mail this completed form to the Research & Development
Office on pma01@keele.ac.uk.
If it is a University project, please e-mail this completed form to the Research
Governance Officer on n.leighton@uso.keele.ac.uk
72
You also need to send a hard copy to the Research Governance Officer, Office of
Research & Enterprise, Dorothy Hodgkin Building, Room DH1:13, Keele University,
Staffs, ST5 5BG.
If you have any queries, please ring 01782 583306 or e-mail n.leighton@uso.keele.ac.uk
73