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Stage 6: Hazard Log Drafts (DCB 0129/0160 Compliant)

Generated: 8 February 2026 Pipeline Stage: 6 of 6 (FINAL STAGE) Status: ✅ COMPLETE

Overview

This directory contains 47 structured hazard log drafts in DCB 0129/0160 compliant format, ready for Clinical Safety Officer review. These drafts represent the final output of the automated hazard analysis pipeline.

Contents

  • 47 Hazard Log Files: Hazard-0001.md through Hazard-0047.md
  • Format: Structured markdown with standardised field separators (---)
  • Compliance: DCB 0129 (Clinical Risk Management) and DCB 0160 (Clinical Safety Case)

Hazard Log Format

Each hazard log contains the following standardised sections:

Core Identification

  • Hazard name: Short descriptive title
  • General utility label: [2] (New hazard for triage)
  • Likelihood scoring: TBC (awaiting Clinical Safety Officer assessment)
  • Severity scoring: TBC (awaiting Clinical Safety Officer assessment)

Hazard Description

  • Description: Concise 1-3 sentence summary
  • Causes: Numbered list of root causes
  • Effect: Change in intended care pathway
  • Hazard: Potential for harm (even if unrealised)
  • Hazard type: Bullet list (e.g., WrongPatient, UnauthorizedAccess)
  • Harm: Actual patient harm if hazard realised

Controls & Mitigation

  • Existing controls: "None identified during initial analysis."
  • Hazard controls:
  • Design controls (manufacturer)
  • Testing controls (manufacturer)
  • Training controls (deployment)
  • Business process controls (deployment)

Risk Assessment

  • Residual hazard risk assessment: TBC — awaiting initial controls implementation.

Administrative

  • Assignment: Clinical Safety Officer
  • Labelling: TBC (awaiting scoring)
  • Project: Clinical Risk Management
  • Hazard status: Draft from LLM
  • Code associated with hazard: File paths and line numbers

Clinical Safety Officer Actions Required

For each hazard, the Clinical Safety Officer must:

  1. Review and validate hazard description, causes, effects, and harm
  2. Score likelihood (1-5 scale: Very low to Very high)
  3. Score severity (1-5 scale: Minor to Catastrophic)
  4. Calculate risk (automatic from likelihood × severity matrix)
  5. Review proposed controls and determine which to implement
  6. Assign hazard to appropriate team member/manufacturer
  7. Update status from "Draft from LLM" to "Open" when validated
  8. Add labelling based on risk scoring

Hazard Categories

The 47 hazards span multiple categories:

Patient Identification (13 hazards)

  • Wrong patient identity displayed
  • Missing demographics
  • Age calculation errors
  • NHS number validation
  • Avatar gradient confusion
  • Stale patient data
  • Duplicate patient records
  • Patient list race conditions
  • Letter/patient mismatches
  • Optional field handling
  • FHIR gender validation
  • Avatar gradient FHIR extensions
  • Orphaned EHRbase letters

Authentication & Security (15 hazards)

  • JWT token expiry during clinical sessions
  • Missing rate limiting
  • CSRF protection gaps
  • Weak random number generation
  • Authentication race conditions
  • TOTP validation issues
  • Logout failures
  • Password hashing without pepper
  • JWT/CSRF secret reuse
  • TOTP secrets not encrypted
  • Default active user accounts
  • Missing audit trails
  • No email verification
  • Login response information disclosure
  • Secrets logging

Data Integrity (8 hazards)

  • Duplicate FHIR patient creation
  • Invalid FHIR gender values
  • EHRbase EHR creation race conditions
  • Invalid letter content
  • Service worker cache staleness
  • Push notification associations
  • Date format locale assumptions
  • Database connection exhaustion

Infrastructure & Operations (11 hazards)

  • FHIR server health check false negatives
  • Weak configuration secrets
  • Caddy reverse proxy rate limiting
  • EHRbase API exposure
  • Overly permissive CORS
  • Docker resource limits
  • Backend/FHIR startup ordering
  • Database migration backup validation
  • Push notification endpoint authentication
  • API path validation
  • API client token refresh loops

Next Steps

  1. Clinical Safety Officer Review: Schedule review meeting for all 47 hazards
  2. Prioritisation: Identify high-risk hazards requiring immediate mitigation
  3. Assignment: Distribute hazards to development team and deployment teams
  4. Implementation Tracking: Create GitHub issues or Jira tickets for each hazard control
  5. Residual Risk Assessment: After controls implemented, re-assess likelihood and severity
  6. Hazard Log Publication: Transfer validated hazards to official Clinical Risk Management File

Pipeline Execution Summary

Stage 1: Code file discovery and patient safety analysis → 47 potential hazards identified

Stage 2: Hazard extraction and structuring → 47 structured hazards

Stage 3: Cause analysis and root cause identification → Causes documented

Stage 4: Harm assessment and clinical impact → Harm scenarios defined

Stage 5: Mitigation strategy generation → 4 control types per hazard

Stage 6: DCB 0129/0160 hazard log draft creation → 47 compliant drafts ✅

Compliance Notes

These hazard logs are structured to support:

  • DCB 0129: Clinical Risk Management system requirements
  • DCB 0160: Clinical Safety Case Report requirements
  • NHS Digital DTAC: Digital Technology Assessment Criteria
  • CQC Registration: Safe and effective care domain evidence

All hazards require Clinical Safety Officer sign-off before system deployment.

File Naming Convention

  • Format: Hazard-NNNN.md (4-digit zero-padded)
  • Range: Hazard-0001 through Hazard-0047
  • Immutable IDs: Hazard numbers assigned permanently, not reused if hazard closed

Maintenance

  • New Hazards: Add as Hazard-0048, Hazard-0049, etc.
  • Closed Hazards: Update status to "Closed" but retain file for audit trail
  • Merged Hazards: Mark duplicates as "Transferred" with reference to master hazard
  • Version Control: All changes to hazard logs must be committed to Git with explanation

Contact

Clinical Safety Officer: TBC Clinical Risk Management File Location: TBC System Deployment Review Date: TBC

Generated by automated hazard analysis pipeline. All hazards require human Clinical Safety Officer review and validation before use in clinical risk management.