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.