Rule breaking and normalisation of deviance
There were several areas where the guidance in SOPs was either insufficiently or imperfectly described, or where the team were ‘forced’ to bend the rules to achieve the task. Examples are provided below:
1) Personal Protective Equipment (PPE): At the time of data collection, guidance on expected levels of PPE were available from multiple sources including UK Health Security Agency, the National Institute for Care Excellence (NICE) CG139, the University of Oxford and the OUHT. In addition, the OxCRF had core prescribed PPE requirements (e.g. limits on staff within certain spaces and disposable surgical masks to be worn at all times within the unit) and the study stipulated supplemetary needs (e.g. times at which certain levels of PPE are required). This resulted in differing baseline assumptions of PPE requirements between staff dependent on usual place of work and conflicting guidance for team members to follow in specific circumstances. The consequence was situations where team members exposed to the same level of risk, for example when transporting the virus to the participant, were (by rule) expected to wear discrepant levels of PPE throughout the journey, and in relation to their co-located colleagues. The SOP failed to capture nuances of the process and thus confidence in the rule around PPE was eroded by visible inconsistencies (e.g. staff near to, but not holding, the contained live pathogen wearing lower levels of PPE). Equally, when transferring participants from the OxCRF to OUHT for scanning, the COV-CHIM study team reported confusion around which requirement to adhere to (i.e. took precedence) and were often, but not always, required to change their PPE to OUHT provided equipment without a clear biological rationale.
2) Use of signage: A ‘do not enter’ sign was placed on the door in advance of the inoculation taking place. Several team members were observed to go in and out of the participant’s room whilst the sign was on the door, i.e. the sign has no real utility for indicating the exact time when they shouldn’t be entering. The placement of the sign should be contemporaneous with the safety critical moment of transfer of the pathogen into the room. Rule-breaking is inevitable in this situation as staff learn use of the sign is misaligned with risk, and failure to proceed despite its presence would hinder trial conduct.
3) Participant transfer: During transfer to the CT scanner team members were instructed not to touch any surface. However, unidentified impediments were observed as the doors in the OxCRF cannot be fixed in an open position. Consequently the participant either held the door themselves, or the staff opened the door for them, leading to the rules on social distancing and infection control described in the SOP being broken.