Assurance
Safety case

Safety case appendix

Drop-in safety case content for DCB0129/0160 packages.

All clinical safety resources

Clinical Safety Hub
DCB0129 / DCB0160

Clinical safety evidence for CliniSearch deployments.

CliniSearch is a clinical decision support information system. This page holds the safety case appendix, hazard log template, and CSO scope needed for local governance.

Local deployment safety responsibility remains with the organisation; we supply evidence, controls, and templates to accelerate DCB0129/0160 compliance.

Safety case appendix Hazard log template CSO roles & scope

Patient safety context

Supports CQC Safe quality statements (SAFE1, SAFE2) with secondary alignment to WL1, NHS Standard Contract clauses for governance and data protection (SC5, SC23, SC24, SC35), and PSIRF principles for safety management systems, hazard identification, and learning.

CliniSearch is managed as a clinical decision-support system; hazards are identified and controlled within local DCB0129/0160 processes. Responsibility remains with the deploying organisation.

Safety case appendix

Downloadable appendix detailing hazard analysis, mitigations, and boundary statements.

Scope & boundary

CliniSearch provides cited guideline retrieval and structured display. It does not automate clinical decisions.

  • Decision support; clinician remains the decision-maker.
  • Content provenance and version timestamps shown.
  • Local policy overlays supported, not overridden.

Mitigation themes

Controls to address the most common risks in clinical search and guideline delivery.

  • Inline citations with source and version.
  • Change visibility and audit logging.
  • Explicit reminders to follow local policy.

Hazard log template

Starter hazard log with common failure modes and suggested mitigations for clinical search.

Included hazards

  • Outdated guideline content surfaced to clinicians.
  • Ambiguous thresholds (referral, prescribing, monitoring).
  • Local policy divergence not visible at point of care.
  • Incomplete audit trail for governance review.

Mitigation starters

  • Version-timestamped answers with inline citations.
  • Update monitoring and change summaries.
  • Local policy overlays and deviation notes.
  • Search audit logs with user, time, and source.

We adapt the log to Trust-specific pathways on request.

Clinical Safety Officer roles & scope

Outlines what we provide, what your CSO owns, and how we support sign-off.

What we supply

  • Safety case appendix and hazard log starter.
  • Architecture and data-flow diagrams.
  • Change management and release notes.

What your CSO owns

  • Local hazard assessment and residual risk sign-off.
  • Integration checks (SSO, audit feeds, intranet links).
  • Clinical safety training and communication locally.

Joint responsibilities

  • Testing against local pathways before go-live.
  • Incident reporting and post-incident review.
  • Quarterly review of hazard log and mitigations.

Local deployment responsibility

CliniSearch supports safe deployment; accountability stays with the deploying organisation.

  • CliniSearch is a clinical decision support information system; it does not replace clinician judgement.
  • Local organisations remain responsible for ensuring DCB0160 compliance and CSO sign-off.
  • We provide evidence packs, but Trusts own operational controls (access, monitoring, incident response).

We can co-run safety reviews with your CSO to speed up approval.

Request the clinical safety pack

Includes the safety case appendix, hazard log template, and CSO scope summary.

Related governance controls

Link to governance evidence that supports Clinical Safety controls.