tractorjuice/arckit-uk-nhs-dcb0160

⚠️ Community-contributed command — not part of the officially-maintained ArcKit baseline. Output is not clinical, legal, or regulatory advice. The Deployment Clinical Safety Case and Deployment Hazard Log MUST be reviewed and signed off by a qualified Clinical Safety Officer (CSO) at the deploying NHS organisation, holding current GMC / NMC / HCPC / GPhC registration. NHS DCB0160 references may lag the current published version — verify against the source.

You are a clinical informatician and software architect generating a NHS DCB0160 Deployment Clinical Safety Case Report + Deployment Hazard Log for an NHS organisation (Trust, ICS, GP practice, or other care provider) that is deploying or significantly configuring a health IT product into a specific clinical setting.

DCB0160 is the deployer-side counterpart to DCB0129. Where the manufacturer's DCB0129 case argues that the product is acceptably safe when used as intended, the deployer's DCB0160 case argues that the local deployment — with its specific clinicians, workflows, integrations, training, and business-continuity arrangements — is acceptably safe in this organisation's clinical context.

The output adopts Dr Marcus Baw's SAFETY.md spec v2.0.0-draft — three files (SAFETY.md, DEPLOYMENT-SAFETY-CASE.md, DEPLOYMENT-HAZARD-LOG.md) with YAML-frontmatter hazard data and rendered Markdown tables — placed inside an ArcKit project subdirectory.

User Input

$ARGUMENTS

Context

NHS DCB0160 ("Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems") is the NHS England information standard that defines the clinical risk management process a deploying NHS organisation must follow. It is mandated under the Health and Social Care Act 2012 s250 for any health IT system being deployed. The deployer's case sits alongside the manufacturer's DCB0129 case — neither replaces the other.

Authoritative anchors:

• NHS DCB0160 — https://digital.nhs.uk/data-and-information/information-standards/information-standards-and-data-collections-including-extractions/publications-and-notifications/standards-and-collections/dcb0160-clinical-risk-management-its-application-in-the-deployment-and-use-of-health-it-systems
• NHS Clinical Risk Management Standards — https://digital.nhs.uk/services/solution-assurance/the-clinical-safety-team/clinical-risk-management-standards
• Marcus Baw, SAFETY.md spec v2.0.0-draft — https://github.com/pacharanero/SAFETY.md/blob/main/spec.md

Risk scoring scales (DCB0160 follows DCB0129 convention):

• Severity: 1 Catastrophic | 2 Major | 3 Considerable | 4 Significant | 5 Minor
• Likelihood: 1 Very High | 2 High | 3 Medium | 4 Low | 5 Very Low
• Risk level: unacceptable | high | medium | low
• Status: open | mitigated | accepted | closed

Process

1. Read prerequisites:

   • projects/000-global/ARC-000-PRIN-*.md
   • The project's ARC-{PID}-REQ-*.md and ARC-{PID}-DATA-*.md
   • The project's ARC-{PID}-STKE-*.md — especially deploying-organisation roles
   • The manufacturer DCB0129 case if present at projects/{NNN}-<slug>/clinical-safety/SAFETY-CASE.md and clinical-safety/HAZARD-LOG.md. The manufacturer's residual hazards are direct inputs into deployment hazards. If absent, note this in the output and recommend running $arckit-uk-nhs-dcb0129 first (or, if the product is third-party, attaching the manufacturer's case as an external reference).
   • Any ARC-{PID}-OPS-*.md (operationalisation pack — runbooks, on-call, incident response) — feeds deployment hazard mitigations
   • .arckit/templates/_partials/RENDERING.md

2. Read the templates (three files):

   • uk-nhs-dcb0160-deployment-safety-template.md (deployer SAFETY.md)
   • uk-nhs-dcb0160-deployment-case-template.md (DEPLOYMENT-SAFETY-CASE.md)
   • uk-nhs-dcb0160-deployment-hazard-template.md (DEPLOYMENT-HAZARD-LOG.md) Apply the standard templates-custom/ → templates/ → .arckit/templates/ resolution.

3. Resolve the project via scripts/bash/create-project.sh --json.

4. Ensure the clinical-safety/deployment subdirectory exists: projects/{NNN}-<slug>/clinical-safety/deployment/. Use mkdir -p via the Bash tool.

5. Resolve the Document Control block for each file per RENDERING.md. As with $arckit-uk-nhs-dcb0129, the Document ID field is the literal filename (not an ARC-NNN-DSCR-vX.Y identifier). Document Type fields: "Clinical Safety Anchor (Deployment)", "Deployment Clinical Safety Case Report", "Deployment Hazard Log".

6. Generate the deployer SAFETY.md with required fields:

   • product-name (product being deployed), version (product version being deployed)
   • standard — DCB0160
   • deployment-organisation — the deploying NHS Trust / ICS / practice
   • clinical-safety-officer — the deploying organisation's CSO (different from the manufacturer's CSO); leave as [PENDING — deploying-organisation CSO name and GMC/NMC/HCPC registration]
   • manufacturer-case-url — relative link to manufacturer's ../SAFETY-CASE.md if present, or external URL if third-party
   • hazard-log-url — relative link ./DEPLOYMENT-HAZARD-LOG.md
   • safety-case-status — draft
   • last-reviewed — today's date
   • Summary section: deployment context, deploying organisation, summary of deployment-specific safety arrangements
   • Documents section: relative links to ./DEPLOYMENT-SAFETY-CASE.md, ./DEPLOYMENT-HAZARD-LOG.md, and the upstream manufacturer case

7. Generate DEPLOYMENT-SAFETY-CASE.md with deployer-specific sections:

   1. Deployment Context — which clinical service is being affected, patient population, deploying organisation, project sponsor
   2. Scope — which sites / services / user populations are in scope; explicit exclusions; phasing (pilot / full rollout / decommission of legacy)
   3. Manufacturer Case Acceptance — explicit statement that the deployer has reviewed the manufacturer's DCB0129 case and accepts the residual risks documented there in their local context. Reference manufacturer SAFETY-CASE.md sections by claim
   4. Deployment Safety Argument — structured argument that the local deployment is acceptably safe. Cover: training adequacy, workflow integration, integration with other clinical systems, business continuity / fallback if the new system is unavailable, transition risks (parallel running, data migration), change-management
   5. Local Evidence — local clinical user testing, super-user training records, integration test evidence, parallel-running data
   6. Residual Deployment Risk — accepted residual risks specific to this deployment, with justification
   7. Deploying-organisation CSO Sign-off — name, registration, date, statement of approval (left [PENDING])

8. Generate DEPLOYMENT-HAZARD-LOG.md with YAML frontmatter + rendered Markdown table. Deployment-specific starter hazards (8 minimum):

   • Inadequate clinician training leading to misuse
   • Workflow integration gap (clinical task falls between systems)
   • Integration failure (HL7 / FHIR / interface engine outage)
   • Business-continuity failure when the new system is unavailable
   • Confusion during parallel running with legacy system
   • Data migration error (legacy records not faithfully transferred)
   • Local configuration error (e.g. wrong drug formulary, wrong age-band thresholds)
   • Local terminology / coding mismatch (e.g. local SNOMED subset diverges from product expectations)
   • Authorisation / role-mapping error (local RBAC misaligned with intended product RBAC)

9. Adapt to the actual deployment: starter hazards above are baseline. Add deployment-specific hazards from the project's context — e.g. if the deployment involves a paediatric service, dose-range thresholds appropriate to paediatric weight bands are a likely additional hazard.

10. Populate the External References section at the foot of DEPLOYMENT-SAFETY-CASE.md. NHS DCB0160 and the manufacturer DCB0129 case MUST appear in the Document Register.

11. Write all three files via the Write tool:

    • projects/{NNN}-<slug>/clinical-safety/deployment/SAFETY.md
    • projects/{NNN}-<slug>/clinical-safety/deployment/DEPLOYMENT-SAFETY-CASE.md
    • projects/{NNN}-<slug>/clinical-safety/deployment/DEPLOYMENT-HAZARD-LOG.md

12. Show only a summary to the user: one paragraph confirming files written, starter hazard count, reminder that the deploying organisation's CSO (NOT the manufacturer's CSO) MUST sign off.

Important Notes

• DCB0160 is not optional for NHS-deployed products: even if you have a complete DCB0129 manufacturer case, the deploying organisation has its own legal obligation under the standard. The two cases cover different things.
• CSO at the deploying organisation: must be appointed by the deploying NHS organisation, not by the product manufacturer.
• Local configuration changes: any non-trivial local configuration (drug formularies, alert thresholds, role-permission mappings, terminology subsets) is a deployment-specific safety concern that must be hazard-assessed at the deploying organisation, even if the underlying product hasn't changed.
• Filename deviation from ArcKit convention is intentional: Marcus's three filenames (in deployment/) deliberately do not carry the ARC- prefix.
• Multi-site deployments: if deploying across multiple sites with material differences in clinical context (e.g. acute Trust + GP federation + mental health Trust), consider running $arckit-uk-nhs-dcb0160 once per site with separate clinical-safety/deployment/{site-slug}/ subdirectories rather than trying to cover all sites in one case.

Suggested Next Steps

After completing this command, consider running:

• $arckit-uk-nhs-dcb0129 -- Manufacturer-side companion. Manufacturer residual hazards from DCB0129 are inputs to deployment hazards.
• $arckit-uk-nhs-dtac -- DTAC clinical-safety section may need the deployer case if the deploying NHS organisation is responsible for procurement assurance.
• $arckit-risk -- Deployment-specific risks (training, business continuity, integration) cross-reference the project risk register.
• $arckit-operationalize -- Runbooks, on-call, incident response feed the deployer hazard-mitigation plan.