Biological & Genetic Modification - University of Bristol

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Biological & Genetic Modification

Safety Committee



CONTROL OF SUBSTANCE
S HAZARDOUS TO HEALT
H (COSHH) REGULATION
S


R
ISK ASSESSMENT OF
AN ACTIVITY INVOLVIN
G DELIBERATE WORK WI
TH BIOLOGICAL AGENTS

OR WORK
WITH POTENTIALLY INF
ECTIOUS OR HARMFUL B
IOLOGICAL SUBSTANCES


This risk assessment template can be used to assess the hazards and risks from an activity involving deliberate work
with an
infectious or harmful biological agent or work with primary human or animal tissue, blood, excreta or other body
fluids. The aim of the assessment is to identify those at risk from infection or other harm and the measures required to
eliminate or control t
he risks to human health and safety and the environment to an acceptable level.


It is the responsibility of the PI to ensure that this risk assessment remains valid and that all personnel undertaking this
research have read and understood the risk assessm
ent. Record sheets are appended to facilitate this and

more

are
available from the Health and Safety Office website. Any significant changes to the risk identified
will

require BGMSC to
re
-
approve the risk assessment
where measures from
containment level 2

or above

are specified
. Changes to personnel
working on approved projects should also be notified to your local Deputy Biological Safety Officer.



PRINCIPAL INVESTIGATOR OR SUPERVISOR

Name

Department

Position






















PERSON UNDERTAKING
THIS
RISK ASSESSMENT
(if different from above)

Name

Department

Position






















PROJECT TITLE










PREMISES
WHERE THIS WORK WILL BE CARRIED OUT

Department

Room(s)















INITIAL PERSONNEL WHO WILL UNDERTAKE EXPERIMENTAL WORK

Name

Biological Worker Registration #

















For BGMSC use only

Date Approved:

Signed:

Containment Level:


1 2
3

Derogation: Y / N

HSE Ref #:

BGMSC #:


REFERENCE
OTHER R
ELEVANT RISK ASSESSMENTS

(e.g. for

hazardous

chemicals, ionising radiation, cryogenic gases etc.)








COSHH
-
BA 2010
-
1

Page
2


1. SUMMARISE THE ACTIVITY


1.1 Brief Overview of work:
(
include aims and objectives in simple terms.)












1.
2 Description of experimental procedures:

(Brief details, also indicate

any non
-
standard laboratory
operations and any procedures that might require specific control measures e.g. use of sharps, generation of
aerosols, in vivo work)













2. IDENTIFY THE HAZARDS AND ASSESS THE RISKS TO HEALTH AND SAFETY



2.1 List any micro
-
organisms
deliberately

used

and any
attenuations

(genetically modified strains will
require a GM risk assessment to be completed)
:

Micro
-
organism

Attenuations (if
relevant)

















2.2 List any tissues or cells to be used:

Species

Organ

Tissue/cell

Source




























2.3 List any blood, saliva, excreta or other body fluids to b
e used:

Species

Material

Source





















2.4 Give details of any other
materials

that may contain infectious or harmful
substances











2.5 Quantities used and frequency of use:

(Th
is information will enable you to determine the likelihood of
exposure and therefore the risks from this particular activity. Please indicate maximum culture volumes at
any time shown as multiples of flask volumes to give an idea of scale.)


Max. volume pe
r culture:







Max. volume per experiment:







Quantity of other substances:







Frequency of experiments (/exposure):










2.6

Will any primary material have been screened for infectious agents and/or will clin
ical information
be made available?


COSHH
-
BA 2010
-
1

Page
3


YES

NO

NOT APPLICABLE





If yes, summarise the screening undertaken, the clinical information included and any rejection policy:











If y
es, what arrangements are in place for provision and dissemination of clinical information received
after the project has started ?











2.
7

If cell culture is involved, is health and safety information available (e.g. from a culture co
llection,
references etc.)?



YES


NO

NOT APPLICABLE




If yes, summarise:










2.8

If animals will be used in this project please give details of the procedures and identify an
y
significant hazards resulting from these (e.g. bites, scratches, shedding of infectious material etc.)










Information on any identified hazards and risk control measures must be provided to animal care staff using
the form “Provision

of Health and Safety Information to ASU Staff by Research Staff” available from ASU and
http://www.bristol.ac.uk/safety/biological/forms




2.9

Classify the micro
-
organisms deliberately us
ed or that
may be

present in the materials used and
provide any information available on the likely incidence and numbers of the micro
-
organisms in this
material



referencing previous answers where relevant
.


Micro
-
organism

Hazard Group
*

Explain l
ikelihoo
d of presence

if not deliberate use




















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

for the approved list of biological agents and hazard g
roups




2.10

Identify
potential

route(s) of infection in the laboratory:


Percutaneous

Inhalation

Ingestion

Splash in eyes or mouth

Animal bite or scratch


YES

NO


YES

NO


YES

NO


YES

NO


YES

NO



2.
11

Describe any disease or
other
harm that may be caused

by exposure to the substances used
:

(including symptoms, severi
ty, routes of transmission, allergies etc.)








COSHH
-
BA 2010
-
1

Page
4




2.
12

Identify any particular groups of workers who may be at increased risk:
(for example pregnant
workers, young persons under 18, disabled workers, those with pre
-
existing disease that

increases
susceptibility.)








Anyone who might have compromised resistance to disease for any reason should seek advice from
the University Occupational Health Service regarding the need for additional precautions.




2.
13

Could a less

hazardous substance (or form of the substance) be used instead?
(If
it can, then it
should be used or justification be given here why it is not being used. COSHH requires substitution with less
hazardous materials wherever possible, but there may be good

reasons for not using them.)












3. DECIDE WHAT MEASURES ARE NECESSARY TO PREVENT OR CONTROL THE RISKS


Exposure prevention


3.1 W
ill the work be segregated from

others not involved in the work and if not, how will they be
informed of the hazards?
:












E
xposure control


3.2

Microbiological Safety Cabinet:




YES

NO


Class:


I

II

III



3.2
.1 Specify other local

ventilation control measures

considered app
ropriate

(e.g. downdraft t
able,
isolator
):















3.3
Will c
entrifugation
be used
?


YES

NO





If yes, w
ill buckets and rotors be sealed
?


YES

NO



If yes, where will buckets or rotors be
opened?







If yes, how will spillages in the centrifuge be
dealt with?









3.4
Will i
ncubators

be

used
?


YES

NO



COSHH
-
BA 2010
-
1

Page
5


If yes, what type (e.g. shaking)?







If yes, how will spillages in the
incubator be
dealt with?









3.5
Will s
harps
be
used:



YES

NO




If yes, list and justify
their
use:







Control measures (e.g. training, supervision):









3.6
How will viable material be transported within the laboratory

?












3.7 How will viable material be transported locally outside the laboratory ?












3.8 Will viable material be shipped anywhere?


YES

NO




If yes, what will be shipped?







If yes, how will this be shipped (e.g. Category
A, Category B, Exempt
, Non
-
hazardous
)?










3.
9

Person
al Protective Equipment (PPE):


Lab coat

Gloves

E
ye or face (specify if yes)

Other (specify)

YES


YES

NO




YES

NO









Details:







Details
:









3.10 Containment Level
-

what containment level is required for this work with regard to COSHH
Schedule 3
?
(
for guidance
see http://www.bristol.ac.uk/safety/bio
safety/#guidance
)


Containment Level
(
tick

as appropriate)

With derogation
from the following controls

(
list if relevant
and justify
)


1


2


3







Check and confirm that local rules and policies are in place that set out the detailed control measures for
work in the laboratory/facility and the local disinfection policy. Ensure that you are familiar with them and they
are applicable to your wo
rk.



3.11 Waste disposal procedures:


(Disinfectants, concentrations, exposure times, autoclaving procedures, incinerator procedures
, include any
animal related wastes
.)

COSHH
-
BA 2010
-
1

Page
6



Decontamination method

Validation of this method

Disposal route

e.g. drain/inciner
ation/landfill

Liquid waste



















Solid waste



















Sharp waste













Incineration



3.12 Emergency procedures:

(Local laboratory rules and the departme
ntal disinfection and waste disposal
polices should cover most eventualities such as spillages. This section only needs completing if a hazard has
been identified which requires other, special procedures in an emergency)


Inside primary containment (if rel
evant e.g. MSC, isolator):












Outside primary containment but within the laboratory (secondary containment):












Outside secondary containment (if relevant):












Other procedures

(e.g. following
any kind of
accidental exposure)
:










The needlestick injury hotline is available to provide advice, post exposure treatment and counselling where
required


0117 342 3400 [delete if not appropriate]





4. ENSURE CONTROL MEASURES ARE USED AND MAINTAINED



4.1 Specify
what, if any, checks on control measures are required and state the frequency of inspection
needed: (
Simple visual inspections may suffice or in some cases more detailed examinations, especially of
engineering control measures, may be required. Microbiolog
ical safety cabinets are required to be tested
annually or every 6 months in CL3.)












5. MONITOR EXPOSURE OF WORKERS (IF NECESSARY)



COSHH
-
BA 2010
-
1

Page
7

5.1
Specify if environmental or personal monitoring is required:
(This is very rarely required for biological
work. Please take advice from the University Health and Safety Office and/or Occupatio
nal Health Service if in
doubt.)











5.2
Specify if health surveillance is required:
(Indicate if
workers must register with the Occupational
Health

Services, e.g. for spirometry)












5.3
Specify if there is there

an effective vaccine available for any of the pathogens handled in this work:
(Advice

can be obtained from

the Occupational Health Service.

The University is required to offer
immunisations to individuals who may be exposed to pathogens at work where an e
ffective vaccine is
available.)













6. PROVIDE INFORMATION, INSTRUCTION AND TRAINING TO PERSONS AT WORK




6.1 Specify training requirements and record keeping:
(
Decide whether any special training is required to
carry out the procedure safely.)











6.2 Spec
ify
how information

will be provided to those at risk of exposure
:
(
University Codes of Practice,

local rules document and disinfection policies should be made available)













7. HUMAN TISSUE ACT AND ETHICAL APPROVAL



Please contact

the Research and Human Tissue Specialist in Research and Enterprise Development
(
http://www.bristol.ac.uk/red/
) for help
with

Human Tissue Act
requirements
and Ethics Committee approval.


7.1 Are any of the m
aterials to be used covered by the Human
Tissue Act?


YES

NO

(if no, go to 8)



7.2 Does this work have ethical approval?


YES

NO


(if no, go to 7.3)



Date of approva
l:







Name of REC








COSHH
-
BA 2010
-
1

Page
8


7.
3

If you answered NO to 7.2
, summarise how you will be complying with the Human Tissue Act (e.g.
licence details, DI consent)?












8. APPROVALS




For work at containment leve
l 1


please consult your Department Safety Advisor (DSA)




For work at containment level 2 and above


approval will be required from the BGMSC. Please submit
this risk assessment to your local Deputy Biological Safety Officer (or DSA) who will arrange thi
s. For
less hazardous work, approval may be given by email provisionally with formal approval at the next
committee meeting.

























COSHH
-
BA 2010
-
1

Page
9

RECORD OF PERSONNEL INVOLVED



BGMSC Risk Assessment #








Risk assessments should be re
ad by all personnel involved in the assessed work and each person should sign
to acknowledge that they understand the assessment. Their qualifications and experiences that make them
suitable for this work should also be recorded. All personnel working with

biological hazards must be registered
with the Health and Safety Office and forms are available on the HSO website for this purpose.



Biological
worker
registration
number

Name


Qualifications

and

Experience

(e.g. safety training
received, research
experi
ence etc)

Signature

Start

date

Finish
date

































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































COSHH
-
BA 2010
-
1

Page
10


REVIEW OF RISK ASSESSMENT


BGMSC Risk Assessment #






GM and COSHH (Biohazard) risk assessments should be reviewed annually or earlier if anything about the
work has changed or if new information becomes available to en
sure that assessments remain valid. Your
local Biological Safety Officer (DBSO) must also be consulted about any amendments to a project risk
assessment as it may be necessary to seek BGMSC and enforcement authority approval.


Reviewed by:






Signature:

Date reviewed:






Amendments:












DBSO consulted
(tick if appropriate)

Action (
if any
):









Reviewed by:






Signature:

Date reviewed:






Amendments:











DBSO consulted
(tick if appropriate)

Action (
if any
):









Reviewed by:






Signature:

Date reviewed:






Amendments:











DBSO consulted
(tick if appropriate)

Action (
if any
):









Reviewed by:






Signature:

Date reviewed:






Amendments:











DBSO consulte
d
(tick if appropriate)

Action (
if any
):