Genetically Modified Organisms (Contained Use) Regulations 2014 (as amended)

Control of Substances Hazardous to Health Regulations 2002 (as amended)

Containment Level 3 Inspection Checklist

Forgenetically modified micro-organisms (assigned to GM Class 3) and/or wild type pathogens (ACDP Hazard Group 3)

Laboratory:

Date of Inspection:

This checklist is based on COSHH (bold), GMO (CU) Regulations, Dangerous Goods Transport and Biosecurity legislation, in order to conduct inspections ofbiological / GM Agent work at Containment Level 3 (CL3). Bullet points are added where ACDP / SACGM / HSE guidance recommends specific practical actions and key Industry Standards are referred to where applicable. There may be other H&S Regulations applicable to the work and other QMULPolicies / Guidance and checklists should also be utilised as required during inspections. This checklist can also be used as a ‘guide’ for CL3 facility planning, design and commissioning and must be used in conjunction withthe detailed ACDP / SACGM, HSE requirements, QMUL Standards and relevant Industry / Sector Standards.

No. / Regulation / Requirement / Achieved / Comments
GMO CU Reg 18 Sch 8/
COSHH Sch 3 or Reg / BIOLOGICAL CONTAINMENT MEASURES AND SAFETY ARRANGEMENTS / YES
(or N/A) / NO
LABORATORY
M1 / Part II 1 / Isolation from other areas in the building (required)
(M1) / Adequate spacing for staff and work undertaken (guidance)
M2 / Part II 4
Guidance / Sealable for fumigation – validated (required)
  • Periodic checks for dust trails conducted – e.g. visual, smoke pencil test

M14 / Part II 7 / Laboratory proofed against disease vectors ( e.g. rodents, arthropods) (required)
M19 / Part II 11 / Observation window or alternative mechanism for viewing all occupants (required)
M 4 / Guidance / Entry to lab via airlock (required if the risk assessment shows) or lobby area (guidance)
M5 / Part II 6
Guidance / Maintain laboratory at negative pressure to atmosphere (required)
  • Control panel for air handling system, gauges / meters, alarms; – user checks

Guidance / Inward air supply to maintain negative pressure to atmosphere.
  • (calibration) tests of room pressures to confirm accuracy of (digital) pressure gauges

(M5) / Guidance / For mechanical ventilation - Supply and extract airflow interlocked to prevent positive pressurisation if extract fails (required)
M6 / Part II 2 / Extract air HEPA filtered (required)
HEPA filter H14 BS EN 1822-1:1998
M11 / Part II / Shower facility available before leaving the laboratory (only if risk assessment requires)
Reg 17 GMP/GOSH
/ Part IV / Biohazard signage on door (required)
EQUIPMENT
M3 / Part II 8 / Bench and floor surfaces impervious to water and easy to clean (required)
  • visual checks for damage / movement

M3 / Part II 9 / Bench and floor surfaces resistant to acid, alkalis, solvents, disinfectants (required)
(M3) / Reg 7 / Hand washing sink (separate from lab sink) with taps operable without being touched by hand; hot water and soap available (required)
M7 / Part II 13 / Suitable Microbiological Safety Cabinet (MSC) or enclosure available for procedures involving infectious material (required)
(M7) / Reg 9
Guidance / MSC / enclosure and any other local exhaust ventilation provided for safety (e.g. HEPA filter for room exhaust) tested and serviced at least every 14 months (required) according to BS EN 12469:2000
  • 6 month test of MSC / enclosure in CL3
  • Test results near or attached to MSC
  • OPF Test (BS 5726:1992) conducted at least every 14 months for MSC / enclosure

(M7) / Reg 9
Guidance / MSC / enclosure user checks conducted (e.g. vane anemometer, visual, alarms) (required)
  • record chart available for inspection

M8 / Reg 7
Guidance / Autoclave available within the laboratory suite (required)
  • Autoclave conforms to BS 2646 and BS EN 12347
  • commissioning records in place

M17 / Guidance / Autoclave cycle validated for wild type pathogen/GMM waste load (guidance).
  • 12 point thermocouple test conducted annually
  • Exhaust filter fitted BS EN 285

(M8) / Guidance / Autoclave records kept; load parameters recorded, maintained and serviced (guidance & other regulations e.g. pressure vessels safety)
(M8) / Guidance / Alternative autoclave or waste disposal arrangements available (contingency arrangements in place)
M16 / Part II / Inactivation of wild type pathogens / GMM’s in effluent or hand wash / shower drainage and validation of effectiveness (only if required by risk assessment)
M18 / Part II 12
Guidance / Laboratory has own dedicated equipment (required SFAIRP)
  • procedure for decontamination of equipment before removal in place and use of decontamination certificate

SYSTEM OF WORK
M9 / Part II 3
Guidance / Access restricted to authorised personnel only. Door closed when work in progress and locked when not in use (required).
  • Documented Permit to Work system / procedure in place for maintenance and entrance by non-users

M10 / Part II 13
Guidance / Procedures generating aerosols contained within MSC or other suitable enclosure (required)
  • secondary containment for internal movement of infectious material sufficient

M10 / Guidance / Centrifuge sealed buckets tested to BS EN 61010-2-20:1995 or equivalent (guidance)
Reg 6
Guidance / Risks from sharps minimised in procedures to negligible risk
  • avoidance of sharps and glassware as far as possible
  • safe sharps use procedures in place

M12 / Reg 8 & 9 / Suitable protective clothing worn as risk assessment indicates (e.g. lab coats / gowns; eye protection; RPE; overshoes) (required)
  • If RPE identified as required, face fit testing conducted for users

M13 / Reg 8 / Protective gloves worn (required)
M12 /
Reg 9 / PPE storage – well defined, clean separated from dirty. (required)
M12 /
Reg 9 / PPE checked at suitable intervals for defects, effectiveness (required)
M12 /
Reg 9 / PPE repair or replaced if defective – system in place (required)
Reg 9 / Decontamination methods for PPE specified, validated for effectiveness (required)
M15 / Part II 5 / Specified disinfection procedure/s for infectious material (pathogen, GMM) in place (routine, spillages, equipment) (required)
M17 / Part II 5 / Chemical disinfectant validated for wild type pathogen / GMM waste (required)
  • Documented evidence for in use / in house / published validation combined with supplier information

(M17) / Reg 7Guidance / Any alternative physical inactivation methods validated (required)
(M17) / Reg 7
Guidance / Safe collection, storage and disposal of waste; waste transported in leak proof containers (required)
  • waste containers / bags labelled (correct waste coding, originator, date, lab)and ID tagged

CDG / ADR / Safe transport of infectious materials (receipt and sending)
  • infectious sample receipt and send according to Dangerous Goods Transport Regulations (classification ,packaging, labelling,)
  • robust and safe procedures for sample receipt and send in place

M20 / Part II 10 / Safe storage of wild type pathogens/GMM’s (required - good practice is within laboratory)
  • Clear labelling (e.g. barcoding) and inventory system.

M21 / Reg 12
Guidance / Written records of staff training available and records retained (required)
  • Comprehensive training list in place and implemented

(M21) / Reg 12 / Instruction for new staff / students in place (required)
Reg 21 (M21) / Reg 13 / Accidents and incidents reported and recorded (required)
Reg 17 Sch 7 / Sch 2A / GMP & GOSH measures
A / Testing and maintenance of control measures and equipment (e.g. servicing, PAT) (guidance & required under other regulations)
B / MSC can be fumigated safely (before filters changed / maintenance of interior / after spillages) (guidance)
  • SOP for procedure (including notifying Estates and other affected depts.)
  • SOP for measuring residual fumigant levels before re-entry

C & M2 / Fumigant can be dispersed safely to atmosphere (required)
D / Alternative methods for neutralisation of fumigant in re-circulating cabinets (e.g. ammonia for formaldehyde) (guidance)
E / Testing for viable organisms outside primary containment (if risk assessment indicates)
F / Prohibition of eating, drinking, applying cosmetics, using tobacco products (required)
G / Prohibition of mouth pipetting (required)
H / Reg 12 / Written SOP for work procedures (required)
I / Reg 12 / Local Code of Practice for safety of personnel and others (required)
ATCSA 2001 / BIOSECURITY
J / Schedule 5 substances held / used / stored
K / Home Office & College BSA notified (required)
L / Security assessment made and communicated to Home Office (required)
M / Substances stored according to security requirements (required)
GM ENVIRONMENTAL RISK ASSESSMENT (In vivo work)
Reg 6 & 7 / QMUL (Generic) environmental risk assessment completed
(Reg 6 & 7) / Separate environmental risk assessment completed (if applicable)
M2 / Animal room(s) separated from other areas by lockable doors (required)
M4 / Part II 8 / Walls, and where risk assessment indicates, ceilings are easy to clean, impervious to water and resistant to disinfectants etc (required)
M6 / Part II 14 / Incinerator available for animal carcasses (can be off site) (required) (incinerator facility to be validated for use)
M7 / Appropriate barriers placed to prevent escape (required)
M8/ Part II 14 / Animals kept in appropriate confinement equipment (cages, pens etc) (required)
M9 / Part II 14 / Animals kept in isolators (required when aerosols produced)
GMO CU / GM RISK ASSESSMENT
Reg 5 or 6; Sch 3 & 4 / Suitable and sufficient risk assessment completed (required)
Reg 19 or 20 / GMM classified and Containment Level specified (required)
Reg 8 / Risk Assessment approved by GMSC (required)
Reg 10 & 11 / RA / CU2 / CU1 acknowledged / approved (consent) by HSE (Class 2 and above) (required)
Reg 14 & 15 / Significant changes / cessation notified to HSE (required)
Reg 14 & 15 / RA and containment measures reviewed periodically (required)
Reg 21 / GMM Emergency plan recorded (if outside persons / environment may be seriously affected) (required) also see COSHH Reg 13
COSHH / WILD TYPE PATHOGEN RISK ASSESSMENT
Reg 6 / Suitable and sufficient risk assessment completed (required)
Reg 6 (Para 77) / Approved Hazard Group identified or for novel agents Provisional Hazard Group assigned (required)
Reg 6 (Para 77) / Exposure risks identified under normal work and uncontrolled release (required)
Reg 6 (Para 77), Sch 3 / Containment (preventative) measures identified to achieve adequate control of exposure (required)
Sch 3 / Containment Level assigned for work (required)
Reg 6 (Para 77) / Risks to health identified (all workers and others who may be affected) (required)
Specific assessment must also be made for the following categories:
  • female workers
  • new and expectant mothers
  • immune compromised / supressed
  • other medical conditions
  • trainees (note - young persons not permitted in CL3)

Reg 11 / Para 77 / Health surveillance needs identified and if identified, health surveillance implemented (required)
Reg 10 / Para 77 / Health monitoring needs identified and if identified, monitoring implemented (required)
Reg 6 (Para 77) / Risk assessment and containment / health monitoring / surveillance measures reviewed periodically (required)
Sch 3 / List of employees exposed to Hazard Group 3 pathogens kept by employer(required)
Sch 3 / Notification of Hazard Group 2 and 3 wild type pathogens made (to HSE, via QMUL BSA) and acknowledgement received (required)
Reg 6 / If derogations from full containment sought, HSE approval sought (via QMUL BSA)
Reg 13 / Provision of first aid facilities adequate (required)
Reg 13 / (i) Information on emergency arrangements available, (ii) communicated to stakeholders and (iii) safety drills conducted (required)
  • responsible person name / contact detail (ext) on door
  • responsible person/s names and contact details (incl OOH) provided to Security / Maintenance

(MH&SWR / SRSCR / HSR) / Consultation and discussion of H&S issues by users / employee representatives
  • CL3 users group
  • Faculty / Institute Safety Groups
  • GMSC

Date of Inspection:

Inspection Team:

NamesSignature

1.

2.

3.

4.

Further comments:

Abbreviations used:

ACDP – Advisory Committee on Dangerous Pathogens

ATCSA 2001 – Anti Terrorism, Crime and Security Act 2001

BSA – Biological Safety Adviser

CDG / ADR - The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations (CDG) and the European agreement "Accord européen relatif au transport international des marchandises dangereuses par route" (ADR)

CU1 / CU2 – HSE GM notification forms

GMM – Genetically Modified Micro-Organism

GMP / GOSH – Good Microbiological Practice / Good Occupational Safety and Health

GMSC – Genetic Modification Safety Committee

HEPA – High Efficiency Particulate Absorption

HSE – Health and Safety Executive

MH&SWR / SRSCR / HSR – The Management of Health and Safety at Work Regulations 1999, The Safety Representatives and Safety Committees Regulations 1977 and the Health and Safety (Consultation with Employees) Regulations 1996.

OOH – Out of hours

PAT – portable appliance testing

PPE – Personal Protective Equipment

RA – risk assessment

SFAIRP – so far as is reasonably practicable

WT – wild type

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