No. SEIPS WORK SYSTEM FACTORS RECOMMENDATION
Rule breaking and normalisation of deviance Rule breaking and normalisation of deviance Rule breaking and normalisation of deviance
1 People Requirements for induction of new staff and communication of changes to existing staff should include simulated walkthroughs of critical tasks and multimodal communication tools (e.g. email, WhatsApp groups, staff briefings). Where tasks are likely to be low frequency, they may be supported by SOPs. Ensure staff coming to the centre understand that the use of checklists is ‘business as usual’ in OxCRF and direct them to guidance and training available for bespoke checklists.
2 Task Clarify and standardise PPE requirements throughout OxCRF, focusing on likely points of proximity to pathogens, as well as specific tasks. Requirements may vary according to activity in OxCRF. This could be communicated at daily briefings.
3 Tools Standardise the format of signage for key procedures in the OxCRF. Consider utilising technology to support standardised, visual confirmation throughout OxCRF that higher risk trial processes are underway (e.g. lit signs in radiology when x-ray is in use)
Standardisation and use of checklists Standardisation and use of checklists Standardisation and use of checklists
4 People Review of training offered in the OxCRF including frequency, types of training (e.g. online, in-situ simulation) and quality assurance processes. Ensure training is offered in the use of checklists.
5 Task Standardise the anaphylaxis box and instructions with those in use in the OUHFT
6 Tools Develop an OxCRF template for checklist design. Trials teams should be encouraged to design checklists for safety critical procedures using guidance in current SOPs. Ultimately a ‘quick reference handbook’ (QRH) much like the national QRH for anaesthetics could be developed
Work system factors – PETT scan Work system factors – PETT scan Work system factors – PETT scan
7 People Team communication to include review of activities at daily briefing (a “safety huddle) which specifies adaptations to activity required e.g. adjusting pathogen collection times to avoid scheduled lab meetings.
8
Environment (physical)
Working with study teams, consider if there is better placement within room of key items (e.g. the clock). Explore if doors in OxCRF have option to remain open without need for physical contact.
9
Environment (physical)
Consider changes to the environment that would improve visibility and audibility during procedures e.g., adapt CCTV technology already in use to allow better monitoring of procedures during the project. An intercom system between participant’s room and corridor would support key tasks, and if more harmful agents being tested, would improve communication with the participant.
10
Environment (physical)
Review of possibilities for donning and (more importantly) doffing PPE in an alternative area.
11
Environment (physical)
Review facilities for staff on site in collaboration with study teams
12 Task Consider detailing ‘go, no-go’ criteria for every study group, and ensure they are understood by all members of the team. Specific communication options (e.g. buzzer) could be used as alerts.
13 Tools Switch to electronic recording system for sample storage
14 Tools Use simulation as a tool to explore pathways and novel procedures and understand latent risks before they become real