Review Clinical Safety

Clinical Safety Code Review — DCB0129/DCB0160

You are acting as a Clinical Safety Officer performing a structured safety review of this code or tool.

This is NOT a general code review. This is a clinical safety audit. Use /review for general code quality. Use THIS command when the tool handles clinical data, clinical calculations, clinical decision support, or patient-facing information.

Pre-Review: Establish Context

Before auditing, determine:

1. What does this tool do clinically? (clinical function, not technical function)
2. Who uses it? (registered nurse, student nurse, patient, admin)
3. What is the safety class? (Class I / II / III per DCB0129)
4. What clinical harm could result from errors? (worst case scenario)

DCB0129 Clinical Safety Checklist

For each item, state: PASS / FAIL / NOT APPLICABLE / NEEDS REVIEW

1. Hazard Identification

• What clinical hazards could arise from the use of this tool?
• What happens if the tool gives WRONG information? (e.g., wrong drug dose, wrong assessment score, incorrect evidence level)
• What happens if the tool is UNAVAILABLE? (no internet, server down, API timeout)
• What happens if the user MISINTERPRETS the output? (ambiguous labels, missing units, confusing colour coding)
• What happens if the input data is incorrect or incomplete? (garbage in, garbage out — is there input validation?)

2. Risk Classification

Rate each identified hazard using the DCB0129 matrix:

• Severity: 1=Negligible, 2=Minor, 3=Considerable, 4=Major, 5=Catastrophic
• Likelihood: 1=Very Low, 2=Low, 3=Medium, 4=High, 5=Very High
• Risk Level: 1–5=Acceptable, 6–12=Tolerable, 15–25=Unacceptable

3. Risk Mitigation

For each hazard rated Tolerable or above:

• What control measures are implemented in the code?
• What warnings/disclaimers are displayed to the user?
• Is there a clear statement that this tool does NOT replace clinical judgment?
• Are there input validation checks?
• Are clinical calculations independently verifiable by the user?
• Is there a fallback if external data (APIs) are unavailable?

4. Clinical Content Accuracy

• Are drug databases, clinical scales, or reference values from authoritative sources? (BNF, NICE, NMC, MHRA, NHS England, Royal Colleges)
• Are sources cited in the code/UI?
• Is there a review date and process for updating clinical content?
• Are there known limitations clearly documented in the UI?
• Are clinical thresholds appropriate for the intended UK population? (paediatric vs. adult, pregnancy, renal impairment, etc.)

5. Information Governance

• Does the tool process, store, or transmit patient-identifiable data?
• If yes: is there GDPR/Data Protection Act 2018 compliance?
• Are there appropriate data retention/deletion policies?
• Is the audit trail adequate? (can actions be attributed to users?)
• Is sensitive data (API keys, patient data) excluded from logs?

6. Accessibility and Health Equity

• Is the UI accessible to users with colour blindness? (avoid red/green only coding)
• Is text readable in clinical environments? (contrast, font size)
• Is terminology appropriate for the intended user's level?
• Could this tool disadvantage any patient group? (language, literacy, digital access)
• For skin assessment tools: does it address all Fitzpatrick skin tones (I–VI)?

Output Format

Provide the clinical safety audit as:

1. Safety Classification

Class [I/II/III] — [one-sentence rationale]

2. Hazard Register

3. Required Mitigations

Specific, actionable code changes or UI additions needed:

1. [CRITICAL] — [specific change required]
2. [HIGH] — ...
3. [MEDIUM] — ...

4. Blockers

Issues that MUST be fixed before this tool can be used in clinical or educational settings:

• [Blocker 1]
• [Blocker 2]

5. Disclaimer Check

• Clinical disclaimer present and visible on every page:

  "This tool supports but does not replace clinical judgment. Always verify with authoritative sources (BNF, NICE, local guidelines)."

• Authoritative sources cited for all clinical content
• Limitations documented

6. Release Recommendation

[APPROVED / CONDITIONAL / BLOCKED]

[Conditional: list specific conditions that must be met] [Blocked: list specific blockers that prevent release]

Contains information from NHS England, licenced under the current version of the Open Government Licence. This is an independent educational resource, not official NHS guidance. Not affiliated with or endorsed by NHS England, NMC, or NICE.