University of Oxford - Department of Medicine



University of Cambridge

NIHR BRC Phenotyping Hub, Department of Medicine

Risk Assessment Form

This form is to be filled in if hazard ratings/quantities/dilutions make University procedures and/or “Good Laboratory Practice” insufficient control.

|Group leader: Anna Petrunkina Harrison |

|Personnel involved: Simon McCallum, Chris Bowman, Natalia Savinykh and all users of flow cytometry equipment in the sorting room |

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|Activity being assessed: HANDLING AND ANALYSING SAMPLES from UNSCREENED HUMAN tissue and blood |

|Hazards identified: |

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|Unscreened human blood may contain Blood Borne Viruses including HIV, Hep BV, Hep CV amongst others and should be handled as such. Other tissues may |

|be similarly contaminated with these agents or harbour other agents associated with them |

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|Hazards from contamination include: |

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|1. Percutaneous inoculation from sharps, including needles, scalpels, broken glass etc. |

|including contamination of exposed skin or pre-existing cuts and abrasions etc. |

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|2. Inhalation of aerosols from shaking, agitation, mixing and failure of containment etc. |

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|3. Ingestion from inadvertent sample to mouth transmission. |

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|4. Contamination of Conjunctivae by inadvertent contact with eyes. |

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|resulting in infection. |

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|Therefore, unscreened human samples should be handled at Containment Level 2 in accordance with the revised ACDP guidance from the HSE. |

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|If there is a significant risk that, or it is actually suspected that, the blood/tissue is infected with any Blood Borne Viruses (BBVs), including |

|the above, or any other pathogenic agent, then a separate Risk Assessment must be carried out in order to reduce the risk (e.g. fixation with PFA) |

|and an appropriate Containment Level used. Such samples can be processed in the sorter room only after enquiries with Biological Safety Officer and |

|after approval by Departmental Biosafety Committee. |

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|Guidance Documents: See |

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|University booklet “Safe Biological Practice (SBP) – for Prevention and Control of Exposure to Biological Agents in the Laboratory” |

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|University Clinical School Guidance on Blood Taking, Blood Handling and Work at Containment Level 2. |

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|Advisory Committee on Dangerous Pathogens (ACDP) Guidance “Protection against blood-borne infections in the workplace- HIV and Hepatitis (HSE/HMSO : |

|ISBN 0 11 321953 9) |

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|Revised Advisory Committee on Dangerous Pathogens Guidance (.uk/ACDP):- |

|Control measures to reduce the level of risk: |

|Unscreened human samples processed for flow cytometry analysis should be handled at Containment Level 2. |

|In addition to the measures and facilities normally specified for work at Containment Level 2 |

|(see relevant guidance), the additional measures listed below should also apply when, as here, Containment Level 2 is specified. |

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|These extra precautions should be in constant use to guard against percutaneous inoculation, contamination of the skin, conjunctivae, mucous |

|membranes and the working surfaces. |

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|• All work must be conducted in a designated containment level 2 work area (Phenotyping Hub sorting lab space) with sufficient space to work safely. |

|The whole sorting room with exception of specially designated office area on the left-hand and right hand side is Containment Level 2 space – these |

|are not to be used for or exposed to samples. |

|• Access to CL2 areas is restricted to authorised staff ONLY, in order to ensure that the person(s) conducting the work is(are) free from the risk |

|of disturbance or accidental contact with others.. Only trained cytometry operators are authorised to work in the sorting room unsupervised. All |

|users are advised that the sorter room is CL2 workspace, and on the necessity to adhere to procedures relevant for handling their own samples and to|

|perform risk assessment for their own experiments. This advice is now incorporated in the training for flow cytometry area. |

|• The use of sharps and glassware must be avoided in the and Sorting lab. Where such use is essential, particular care must be taken in their |

|handling and disposal after contact with unfixed materials, and any exception can be only subsequent to the application and review of the RA for the |

|protocols. |

|• Lesions on exposed skin should be covered with waterproof dressings. |

|• Protective clothing must include an appropriate laboratory gown, disposable gloves and other personal protective equipment appropriate to the task,|

|including eye protection when appropriate. The need for wearing eye protection will be specified in the particular project Risk Assessment prepared |

|by the investigators in consultation with flow cytometry unit, and after approval by the Biosafety Committee. |

|• The workstations must be kept clear of unnecessary equipment and not used for storage. |

|• When operating a sorter etcr, samples must be handled with care, especially when taking them off the injection port and when a blockage has |

|occured. There is a risk of aerosol generation form the sorting equipment. . Sorter is placed into MSC thereby containing the aerosols. The MSC is |

|serviced once a year by contractor. It is a contractor responsibility to calibrate the MSC or otherwise monitor that the settings are appropriate to |

|ensure adequate level of biocontainment. Fumigation of the cabinet is done by a contractor according to an approved SOP and in accordance with the |

|local Rules. All prospective users must fill out and sign a FACS Biosafety assessment sheet for batches of similar sort within a project. The |

|biosafety sheet is signed off by Flow Cytometry and Imaging Officer Simon McCallum, or, in his absence by trained core staff. Only qualified sorter |

|operators (Hub core staff) can make decision on whether to process the samples for sorting and only they can operate sorters. Any obviously CL 1 or 2|

|material can be sorted without delay. All other applications must be sent for assessment/discussion to the Biological Safety Officer Mark Wills. Dr. |

|Mark Wills will assess whether the risk assessment for experiments is adequate, in particular, whether the risk has  been sufficiently reduced by |

|additional procedures and factors (e.g. additional training, special handling procedures which are adequate for each particular project etc) and |

|refer to the Safety Committee in cases of enhanced risk. In situation where the residual risk is still considered to be above CL2 levels, and an |

|approval of Safety Committee cannot be obtained, samples cannot be processed. The bench surface and any equipment must be disinfected immediately |

|after completion of work. |

|Following disinfection policy is in operation: |

|After completion of flow cytometry work, sorter injection tube must be cleaned as described in the guidance notes by the manufactuer . The waste tank|

|needs to be supplemented with Trigene in the quantity prescribed for each particular instruments (final concentration of 10%). NOTE: Virkon must be |

|never used for cleaning sorting equipment injection port or any other parts due to risk of corrosion! |

|In case of spillages, surface area has to be sprayed with Trigene and wiped. |

|• For all operating staff of the Hub conducting work on the sorter, Hep BV vaccine, together with follow-up procedures, is a requirement. |

|• Contaminated waste will be disposed of in accordance with local guidance and rules for the safe disposal of Containment Level 2 waste; including |

|chemical sterilisation of liquids with autoclaving and incinerating for solids as appropriate. |

|Level of risk remaining: |

|Residual risk of percutaneous inoculation; which must be minimised by the avoidance of sharps. |

|Residual risk of splashes in eyes; which must be minimised by use of suitable eye protection. |

|Emergency procedures: NB: See Guidance Documents as above. |

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|First Aid: Wash any contaminated skin, conjunctivae or mucous membrane immediately. |

|In the event of a wound, it should be allowed to bleed by irrigation under running water. |

|Seek medical Advice and contact University Occupational Health Service immediately. |

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|Spillage: All spillages and surface contamination must be immediately cleaned up and removed including decontamination with a suitable validated |

|disinfectant (10% solution of Trigene). |

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|Blockages of the AriaIII: When the AriaIII is blocked, there may be a generation of infective aerosol. The waste drawer and stream should be shut off|

|and the sort chamber opened after checking that the hood still functions. The system should then be left for 5min for any aerosol to evacuate, before|

|spraying the chamber and all other relevant parts/surfaces with 70% Ethanol (gloves must be worn) and attempting repair. Only core staff will deal |

|with the blockage. |

|Major spillages and leaks (resulting in significant surface being covered with fluid, more than 100 ml) should be reported to core manager Simon |

|MCCallum who will assess the incident, keep the record of it and report it to biosafety officer if appropriate. |

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|Name and status of assessor: |Date of assessment: |

|Anna Petrunkina, Director of the Cell Phenotyping Hub |1/09/13 |

|Signature of assessor: |Revision due date: |

| |1/09/14 |

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