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.

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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)

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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:

Hazard	Severity (1–5)	Likelihood (1–5)	Risk Level

• 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)?

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Output Format

Provide the clinical safety audit as:

1. Safety Classification

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

2. Hazard Register

H-ID	Hazard	Severity	Likelihood	Risk Level	Current Mitigation	Status

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]

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_{Contains information from NHS England, licenced under the current version of the <a href="https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/">Open Government Licence</a>. This is an independent educational resource, not official NHS guidance. Not affiliated with or endorsed by NHS England, NMC, or NICE.}