DISCUSSION:
A pre-eminent feature of safety critical organisations is the
“implementation of highly structured approaches to safety management”
such that they are “proactively identifying, assessing, mitigating and
monitoring risk”. A variety of human factors methods exist to explore
and analyse work systems and processes. Some have been developed in
other settings and some adapted or specifically designed for healthcare.
This study has used SEIPS to analyse safety risks during the conduct of
an experimental medicine study in an academic CRF because it was
designed specifically for healthcare contexts and has been adopted for
wider use in the NHS.
The analysis of work as a human endeavour has been the subject of
studies in social and engineering sciences over the past 70 years .
‘Work as Done’ commonly differs from ‘Work as Imagined’ (see Figure 1)
and that discrepancy increases as individuals become more distant from
the actual work environment spatially, temporally and experientially.
Problems arise when managers or policy makers, or in the case of
clinical research, those designing studies, make assumptions about
activity and formulate protocols and guidelines which describe how work
should be performed, without absolute certainty that what one imagines
is achievable will actually be deliverable. This inevitably leads to
rule-breaking by the humans undertaking the tasks in order to get the
work done.
Whilst the safety of study participants was evidently paramount to the
staff of both the facility hosting the observed study (OxCRF) and those
who designed and conducted it (COV-CHIM study team), we found that the
use of structured observations by individuals trained in human factors
methodology recognised latent risks in the protocol as written, the CRF
facility itself and the interaction between the two, that had not been
identified a priori by standard peer review, institutional,
ethical or sponsorship appraisal. In addition, confusion in, or
deviations from, expected practice (often unavoidable) and the
development of local workarounds was catalogued: behaviour that study
and facility leadership were unaware of via conventional pathways. Use
of the SEIPS PETT scan aided the design of recommendations to rectify or
mitigate these risks by the multidisciplinary team and their
prioritisation for implementation based on the established hierarchy of
effectiveness of corrective actions in which physical interventions
(e.g. pathway or equipment redesign) are considered most effective;
procedural interventions (e.g. automation or use of checklists) are
considered moderately effective, and person-based interventions (e.g.
warnings or training) are considered weak.
Given the single-centre, single-study basis of our work it is inevitable
that the specific findings described here will not be wholly
generalisable to other facilities and research programmes. However, this
was not the intent of the study. Instead we sought to understand whether
the use of human factors methods could be extended to early phase and
experimental medicine research with meaningful, actionable results to
improve participant and staff safety. Our experience supports this
assertion but clearly requires both extension and replication. Specific
areas that warrant prioritisation due to their likely commonality across
study type and relevance to multiple CRFs are discussed below.