arckit-cli 6.1.1__py3-none-any.whl

arckit_cli-6.1.1.data/data/share/arckit/.arckit/templates/uk-nhs-dcb0160-deployment-hazard-template.md

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+---
+hazards:
+  - id: D-HAZ-001
+    description: "Inadequate clinician training leading to misuse of the product"
+    cause: "Training scheduled too far ahead of go-live; clinicians joining post go-live miss formal training; high churn in agency / locum cover; super-user model not embedded"
+    effect: "Clinicians use the product incorrectly, with patient safety, data quality, and workflow consequences"
+    severity: 3
+    likelihood: 2
+    risk: high
+    controls:
+      - DC001
+      - DC002
+    residual-severity: 3
+    residual-likelihood: 4
+    residual-risk: medium
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-002
+    description: "Workflow integration gap — clinical task falls between this product and another system"
+    cause: "Workflow mapping missed an edge case; handover-of-care point unclear; ambiguous ownership of a clinical action"
+    effect: "Clinical action delayed or not performed; risk of duplicate action by multiple clinicians each assuming the other will act"
+    severity: 2
+    likelihood: 3
+    risk: high
+    controls:
+      - DC003
+      - DC004
+    residual-severity: 2
+    residual-likelihood: 4
+    residual-risk: medium
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-003
+    description: "Integration failure with another local system (interface engine outage, HL7 / FHIR message loss)"
+    cause: "Interface engine outage; message validation rejection; partner system maintenance window; certificate expiry"
+    effect: "Clinical data not propagated where expected (orders not actioned, results not visible, alerts not triggered)"
+    severity: 2
+    likelihood: 3
+    risk: high
+    controls:
+      - DC005
+      - DC006
+    residual-severity: 2
+    residual-likelihood: 4
+    residual-risk: medium
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-004
+    description: "Business-continuity failure when the product is unavailable (planned or unplanned)"
+    cause: "Cloud provider outage; deployment downtime; failed change; cyber incident; network outage"
+    effect: "Clinicians cannot perform clinical workflow; if no manual fallback, patient care delayed or compromised"
+    severity: 2
+    likelihood: 3
+    risk: high
+    controls:
+      - DC007
+      - DC008
+    residual-severity: 2
+    residual-likelihood: 4
+    residual-risk: medium
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-005
+    description: "Confusion during parallel running with a legacy system"
+    cause: "Two systems show different clinical data; clinicians unclear which is authoritative; data entered into legacy not reflected in new system or vice versa"
+    effect: "Clinical decisions made against an incomplete or out-of-date view"
+    severity: 2
+    likelihood: 3
+    risk: high
+    controls:
+      - DC009
+    residual-severity: 2
+    residual-likelihood: 4
+    residual-risk: medium
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-006
+    description: "Data migration error — legacy records not faithfully transferred to the new product"
+    cause: "Source-target field mapping incomplete; truncation; encoding mismatch; coded data not back-mapped where target uses different vocabulary"
+    effect: "Historical clinical data lost or distorted; clinicians act without full clinical history"
+    severity: 2
+    likelihood: 3
+    risk: high
+    controls:
+      - DC010
+    residual-severity: 2
+    residual-likelihood: 5
+    residual-risk: low
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-007
+    description: "Local configuration error (e.g. wrong drug formulary, wrong age-band thresholds, wrong reference ranges)"
+    cause: "Configuration imported from a different organisation without local verification; reference data updated upstream not propagated; defect in the configuration UI"
+    effect: "Clinical decision support gives wrong recommendation; alerts mis-fire or miss-fire"
+    severity: 2
+    likelihood: 3
+    risk: high
+    controls:
+      - DC011
+      - DC012
+    residual-severity: 2
+    residual-likelihood: 5
+    residual-risk: low
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-008
+    description: "Local terminology / coding mismatch (e.g. local SNOMED subset diverges from product expectations)"
+    cause: "Local SNOMED subset not aligned with product's expected subset; legacy local codes used; dm+d updates not synced"
+    effect: "Clinical concepts mis-interpreted by the product (e.g. allergy not recognised); decision support fails silently"
+    severity: 2
+    likelihood: 3
+    risk: high
+    controls:
+      - DC013
+    residual-severity: 2
+    residual-likelihood: 5
+    residual-risk: low
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-009
+    description: "Authorisation / role-mapping error (local RBAC misaligned with intended product RBAC)"
+    cause: "Local roles do not map cleanly to product roles; local administrator over-provisions for convenience; role review not embedded"
+    effect: "Confidentiality breach or, conversely, clinical action blocked when it should be allowed"
+    severity: 3
+    likelihood: 3
+    risk: medium
+    controls:
+      - DC014
+    residual-severity: 3
+    residual-likelihood: 5
+    residual-risk: low
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+  - id: D-HAZ-010
+    description: "Failure to capture and act on local incidents involving the product"
+    cause: "No clear local reporting route into Datix or equivalent; clinical staff unaware that product incidents should be reported; no escalation path to the manufacturer"
+    effect: "Recurring safety issues not surfaced, not addressed, and not fed back to the manufacturer; latent failure to learn"
+    severity: 3
+    likelihood: 3
+    risk: medium
+    controls:
+      - DC015
+      - DC016
+    residual-severity: 3
+    residual-likelihood: 5
+    residual-risk: low
+    status: open
+    cso-reviewed: false
+    date-raised: "[YYYY-MM-DD]"
+    date-closed:
+
+controls:
+  - id: DC001
+    description: "Training plan published before go-live; mandatory completion gate before clinician account activation; competence assessment built into onboarding."
+  - id: DC002
+    description: "Super-user model embedded per ward/team; super-users have additional time-allocation for floor support; refresh training on each major release."
+  - id: DC003
+    description: "Workflow mapping signed off by clinical leads in each affected service before deployment; explicit handover-of-care responsibility statements per workflow step."
+  - id: DC004
+    description: "Daily safety huddle during pilot and first 30 days of full rollout to surface and resolve workflow gaps quickly."
+  - id: DC005
+    description: "Interface monitoring with alerting on message-rate drop / error spike; on-call procedure for interface engine failure; documented fallback for clinical-priority interfaces."
+  - id: DC006
+    description: "Message replay capability for transient failures; reconciliation reports for batch-processed clinical data."
+  - id: DC007
+    description: "Manual fallback workflow documented per clinical service; printed quick-reference cards held at clinical bases; tested at deployment and refreshed annually."
+  - id: DC008
+    description: "Business continuity drill before go-live and at agreed cadence thereafter; outcomes reviewed by CSO."
+  - id: DC009
+    description: "Single source of truth declared per data class during parallel running, with prominent UI signalling in both systems; minimal parallel-running window; explicit cut-over date communicated."
+  - id: DC010
+    description: "Data migration validation: sample-based clinical review of migrated records; reconciliation of record counts and key fields; rollback plan defined if validation fails."
+  - id: DC011
+    description: "Local configuration sign-off by clinical lead AND CSO; configuration changes peer-reviewed; release-notes review at each product version uplift."
+  - id: DC012
+    description: "Reference data (formularies, age bands, reference ranges) sourced from authoritative upstream where possible (dm+d, NHS BSA, etc.) with automated freshness monitoring."
+  - id: DC013
+    description: "Local SNOMED / coding subset verified against product's expected subset before go-live; gap analysis documented; on-going monitoring of SNOMED release impact."
+  - id: DC014
+    description: "Local role-to-product-role mapping reviewed by deploying-organisation IG lead and CSO; quarterly RBAC review embedded; break-glass usage audited."
+  - id: DC015
+    description: "Local incident reporting route documented and communicated; product-specific Datix category created; routine review of Datix entries tagged to this product."
+  - id: DC016
+    description: "Escalation path to the manufacturer documented (vendor contact, response SLA, vigilance reporting trigger if the product is a medical device)."
+---
+
+# Deployment Hazard Log — [PRODUCT_NAME] at [DEPLOYING_ORGANISATION]
+
+> **Template Origin**: Community | **ArcKit Version**: [VERSION] | **Command**: `/arckit:uk-nhs-dcb0160` | **Filename**: `DEPLOYMENT-HAZARD-LOG.md` (DCB0160 deployer)
+
+## Document Control
+
+| Field | Value |
+|---|---|
+| **Document ID** | `DEPLOYMENT-HAZARD-LOG.md` (Marcus Baw SAFETY.md spec convention) |
+| **Document Type** | Deployment Hazard Log (DCB0160 deployer) |
+| **Project** | [PROJECT_NAME] (Project [PROJECT_ID]) |
+| **Classification** | [OFFICIAL / OFFICIAL-SENSITIVE] |
+| **Status** | DRAFT |
+| **Version** | [VERSION] |
+| **Created Date** | [YYYY-MM-DD] |
+| **Last Modified** | [YYYY-MM-DD] |
+| **Review Cycle** | Monthly during pilot and first 90 days; quarterly thereafter |
+| **Next Review Date** | [YYYY-MM-DD] |
+| **Owner** | [DEPLOYING_ORGANISATION_PROJECT_OWNER] |
+| **Reviewed By** | [PENDING — deploying-organisation CSO] |
+| **Approved By** | [PENDING — deploying-organisation CSO] |
+| **Distribution** | [DISTRIBUTION_LIST] |
+
+## Risk scoring scales (DCB0129 / DCB0160 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`
+
+> ⚠️ DCB0129/0160 inverts the usual Orange Book convention. The numbers above carry the opposite meaning from the project risk register.
+
+---
+
+## Deployment Hazards
+
+*Rendered from the structured YAML at the top of this file. Keep in sync.*
+
+| ID | Description | Sev | Like | Risk | Controls | Residual Risk | Status |
+|---|---|---|---|---|---|---|---|
+| D-HAZ-001 | Inadequate clinician training | 3 | 2 | HIGH | DC001, DC002 | MEDIUM | Open |
+| D-HAZ-002 | Workflow integration gap | 2 | 3 | HIGH | DC003, DC004 | MEDIUM | Open |
+| D-HAZ-003 | Integration failure with another local system | 2 | 3 | HIGH | DC005, DC006 | MEDIUM | Open |
+| D-HAZ-004 | Business-continuity failure | 2 | 3 | HIGH | DC007, DC008 | MEDIUM | Open |
+| D-HAZ-005 | Parallel-running confusion | 2 | 3 | HIGH | DC009 | MEDIUM | Open |
+| D-HAZ-006 | Data migration error | 2 | 3 | HIGH | DC010 | LOW | Open |
+| D-HAZ-007 | Local configuration error | 2 | 3 | HIGH | DC011, DC012 | LOW | Open |
+| D-HAZ-008 | Local terminology / coding mismatch | 2 | 3 | HIGH | DC013 | LOW | Open |
+| D-HAZ-009 | RBAC misalignment | 3 | 3 | MEDIUM | DC014 | LOW | Open |
+| D-HAZ-010 | Failure to capture / act on local incidents | 3 | 3 | MEDIUM | DC015, DC016 | LOW | Open |
+
+## Controls
+
+| ID | Description |
+|---|---|
+| DC001 | Training plan + mandatory completion gate + competence assessment |
+| DC002 | Super-user model embedded with refresh training on releases |
+| DC003 | Workflow sign-off + explicit handover-of-care responsibility |
+| DC004 | Daily safety huddle during pilot + first 30 days |
+| DC005 | Interface monitoring + on-call + clinical-priority fallback |
+| DC006 | Message replay + reconciliation reports |
+| DC007 | Manual fallback workflow + printed reference cards, tested |
+| DC008 | BC drill before go-live + on cadence, reviewed by CSO |
+| DC009 | Source-of-truth declared per data class + UI signalling + minimal parallel window |
+| DC010 | Migration validation: sample review + reconciliation + rollback |
+| DC011 | Configuration sign-off by clinical lead + CSO; peer review |
+| DC012 | Reference data sourced from authoritative upstream with freshness monitoring |
+| DC013 | SNOMED / coding subset verified against product expectation |
+| DC014 | Local role-to-product-role mapping reviewed by IG + CSO, quarterly review |
+| DC015 | Local incident reporting route + product Datix category + routine review |
+| DC016 | Escalation path to manufacturer + vigilance trigger if medical device |
+
+---
+
+## Important
+
+The ten hazards above are a **starter set** drawn from common patterns in NHS health IT deployments. They are not a substitute for deployment-specific hazard identification by the deploying organisation's CSO and clinical SMEs. Many real deployments add 10–30 site-specific hazards (e.g. specific clinical service edge cases, specific local integrations, specific patient-population considerations).
+
+---
+
+**Generated by**: ArcKit `/arckit:uk-nhs-dcb0160` command
+**Generated on**: [YYYY-MM-DD]
+**ArcKit Version**: [VERSION]
+**Project**: [PROJECT_NAME]
+**Model**: [AI_MODEL]
+**Spec lineage**: [Marcus Baw SAFETY.md v2.0.0-draft](https://github.com/pacharanero/SAFETY.md)

arckit_cli-6.1.1.data/data/share/arckit/.arckit/templates/uk-nhs-dcb0160-deployment-safety-template.md

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+# Deployment Clinical Safety — [PRODUCT_NAME] at [DEPLOYING_ORGANISATION]
+
+> **Template Origin**: Community | **ArcKit Version**: [VERSION] | **Command**: `/arckit:uk-nhs-dcb0160` | **Filename**: `SAFETY.md` (DCB0160 deployer anchor)
+
+## Document Control
+
+| Field | Value |
+|---|---|
+| **Document ID** | `SAFETY.md` (deployment) — Marcus Baw SAFETY.md spec convention; no ARC- prefix |
+| **Document Type** | Clinical Safety Anchor (DCB0160 deployer) |
+| **Project** | [PROJECT_NAME] (Project [PROJECT_ID]) |
+| **Classification** | [OFFICIAL / OFFICIAL-SENSITIVE] |
+| **Status** | DRAFT |
+| **Version** | [VERSION] |
+| **Created Date** | [YYYY-MM-DD] |
+| **Last Modified** | [YYYY-MM-DD] |
+| **Review Cycle** | Quarterly (or on any material deployment change) |
+| **Next Review Date** | [YYYY-MM-DD] |
+| **Owner** | [DEPLOYING_ORGANISATION_PROJECT_OWNER] |
+| **Reviewed By** | [PENDING — deploying-organisation CSO] |
+| **Approved By** | [PENDING — deploying-organisation CSO] |
+| **Distribution** | [DISTRIBUTION_LIST] |
+
+## Revision History
+
+| Version | Date | Author | Changes | Approved By | Approval Date |
+|---|---|---|---|---|---|
+| [VERSION] | [YYYY-MM-DD] | ArcKit AI | Initial creation from `/arckit:uk-nhs-dcb0160` command | PENDING | PENDING |
+
+---
+
+## Required SAFETY.md fields (Marcus Baw SAFETY.md spec v2.0.0, deployer adaptation)
+
+| Field | Value |
+|---|---|
+| `product-name` | [PRODUCT_NAME] |
+| `product-version` | [PRODUCT_VERSION_BEING_DEPLOYED] |
+| `standard` | DCB0160 |
+| `deployment-organisation` | [DEPLOYING_NHS_ORGANISATION] |
+| `clinical-safety-officer` | [PENDING — deploying-organisation CSO name and GMC/NMC/HCPC/GPhC registration] |
+| `manufacturer-case-url` | [../SAFETY-CASE.md](../SAFETY-CASE.md) *(or external URL if third-party product)* |
+| `hazard-log-url` | [./DEPLOYMENT-HAZARD-LOG.md](./DEPLOYMENT-HAZARD-LOG.md) |
+| `safety-case-status` | draft |
+| `last-reviewed` | [YYYY-MM-DD] |
+
+---
+
+## Summary
+
+[One to two paragraphs: deployment context (which clinical service, which sites, which patient population), the deploying NHS organisation, summary of deployment-specific safety arrangements (training, fallback, integration, business continuity), phasing if applicable (pilot / staged rollout / decommission of legacy).]
+
+---
+
+## Documents
+
+- [Deployment Clinical Safety Case Report](./DEPLOYMENT-SAFETY-CASE.md) — substantive deployer safety argument
+- [Deployment Hazard Log](./DEPLOYMENT-HAZARD-LOG.md) — deployment-specific hazards (YAML frontmatter + rendered table)
+- [Manufacturer SAFETY-CASE.md](../SAFETY-CASE.md) — upstream manufacturer DCB0129 case *(if same repo)*
+
+---
+
+## Relationship to manufacturer case
+
+The deploying organisation has reviewed the manufacturer's DCB0129 Clinical Safety Case Report and accepted its residual risks **in the context of this specific deployment**. Deployment-specific hazards (training inadequacy, workflow integration, business continuity, local configuration) are documented in this case and are **not** covered by the manufacturer case.
+
+If material residual risks from the manufacturer case are *not* acceptable to the deploying organisation in its local context, the deployment is **not safe to proceed** until those risks are addressed — typically by additional local controls, by configuration changes, or by requesting product changes from the manufacturer.
+
+---
+
+## Important
+
+This document is **not** clinical, legal, or regulatory advice. It is a generated starting point that MUST be reviewed, materially supplemented, and signed off by the **deploying organisation's** Clinical Safety Officer (NOT the manufacturer's CSO) before the product is deployed into clinical use at this organisation.
+
+---
+
+**Generated by**: ArcKit `/arckit:uk-nhs-dcb0160` command
+**Generated on**: [YYYY-MM-DD]
+**ArcKit Version**: [VERSION]
+**Project**: [PROJECT_NAME]
+**Model**: [AI_MODEL]
+**Spec lineage**: [Marcus Baw SAFETY.md v2.0.0-draft](https://github.com/pacharanero/SAFETY.md)

arckit_cli-6.1.1.data/data/share/arckit/.arckit/templates/uk-nhs-dcb0160-template.md

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+# NHS DCB0160 Deployment Clinical Safety Case — Wrapper Template
+
+> **Template Origin**: Community | **ArcKit Version**: [VERSION] | **Command**: `/arckit:uk-nhs-dcb0160`
+
+This wrapper exists only for `/arckit:customize list` and the documentation site. The actual generated outputs are three files under `clinical-safety/deployment/`:
+
+1. [`uk-nhs-dcb0160-deployment-safety-template.md`](./uk-nhs-dcb0160-deployment-safety-template.md) — renders to `clinical-safety/deployment/SAFETY.md`
+2. [`uk-nhs-dcb0160-deployment-case-template.md`](./uk-nhs-dcb0160-deployment-case-template.md) — renders to `clinical-safety/deployment/DEPLOYMENT-SAFETY-CASE.md`
+3. [`uk-nhs-dcb0160-deployment-hazard-template.md`](./uk-nhs-dcb0160-deployment-hazard-template.md) — renders to `clinical-safety/deployment/DEPLOYMENT-HAZARD-LOG.md`
+
+The three files together implement the NHS DCB0160 deployer-side documentation expected by NHS England under the Health and Social Care Act 2012 s250. They follow Dr Marcus Baw's [SAFETY.md spec v2.0.0-draft](https://github.com/pacharanero/SAFETY.md) for filenames and YAML-frontmatter structure, prefixed with an ArcKit Document Control block.
+
+DCB0160 sits alongside DCB0129 — neither replaces the other. The manufacturer's DCB0129 case is the input; the deployer's DCB0160 case argues that *this specific deployment* of the product, with this organisation's clinicians, workflows, integrations, training, and business continuity, is acceptably safe.