arckit-uk-nhs-dcb0160

name	arckit-uk-nhs-dcb0160
description	[COMMUNITY] Generate a NHS DCB0160 deployer Clinical Safety Case Report and deployment Hazard Log for an NHS organisation deploying or significantly configuring a health IT product into a specific clinical setting.

⚠️ 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 section 250 of the Health and Social Care Act 2012 (Part 9 information-standards framework, as amended by the Data (Use and Access) Act 2025) 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
   • Applicable standards and assurance domains and Roles and responsibilities tables: populate using the screening questions in .arckit/references/duaa2025.md. The DCB0160 row is this deployment's own local case; the DCB0129 row references the manufacturer case received from upstream. The deploying organisation's CSO owns only the clinical-safety row; adjacent domains are cross-referenced, not annexed.

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) Before finalising, walk every hazard-archetype family in .arckit/references/hazard-archetypes.md. For each family, either raise at least one hazard or record in the safety case why the family is not applicable to this product. This makes hazard discovery coverage-led, not example-led.

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: Before writing the files, verify the checks in .arckit/references/nhs-clinical-safety-checklist.md and resolve any failures.

    • 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.