Standardisation and the use of checklists
We observed an appreciation of the importance of standardisation of tasks and a clear focus on using SOPs for key procedures during the trial. However, the SOPs were frequently lengthy (ranging between seven and 79 pages for amalgamated documents with multiple elements), and simplified checklists to accompany tasks such as inoculation were not available leading to the development of unapproved ‘workarounds’.
We observed that the study team had designed checklists for use both pre-procedure and during inoculation (see Appendix 1). However, these checklists were not designed according to human factors principles and were cumbersome to use. For instance, the in-room checklist for inoculation was an adapted SOP containing over 50 steps rather than an optimised, task-focused list of safety critical steps, and was being used in paper form in the room with live virus
A standardised approach to the management of potentially life threatening emergencies such as anaphylaxis is important when teams are interacting on an ad hoc basis. Despite the OxCRF having the full complement of emergency equipment and appropriate signposting, the anaphylaxis box was noted to be different from the one used routinely in the OUHT. This may present unnecessary confusion for staff arriving from the hospital to assist in an emergency. Issues with lack of a standardised approach to PPE have already been described above.