Administrative completeness as a safety metric.

Abstract

Traditional safety assessment asks whether an intervention will improve outcomes. This depends on future events, which are not available at the time of assessment. We propose evaluating the documentation, which is.

Method

Each application is assessed for the presence of every required document. Where the document is absent, the application is incomplete. Where it is present, its adequacy must be independently assessed, requiring a further document.

Results

No complete applications have been identified. The resulting absence of approvals is associated with an absence of approved-system incidents. We find a strong correlation between procedural thoroughness and the safety of the procedure.

“The harm of doing nothing is difficult to attribute. The harm of doing something has a signatory.”

Dr. Marie-Claire Derogation, lead author

Discussion

Our method excludes harms that occur in the absence of an intervention. Including them would require the assessment to consider whether its own existence had consequences. This would create a conflict of interest.

Recommendation

Expand the assessment. The uncertainty identified by this paper establishes a clear need for the next paper.