Retinal Screening Assistant
Support ophthalmology screening services by detecting referable diabetic retinopathy in colour fundus images and prioritising cases for specialist review.
- Status
- Approved for operation
- State
- Deployed
- Owner
- Cirocco Jones
- Readiness
- 0
- Blockers
- 12
Findings are computed from record state on every read, evaluated on 2026-07-30. Nothing here is stored on a record.
Blockers
A blocker stops a governance gate from passing.
- BlockerTRACE-01MV-004 has no training suitability record
No Dataset Model record states which Dataset Version was used for training or why it is suitable.
- Affects
- MV-004
- Effect
- Blocks continued operation and PCCP generation.
- BlockerDATA-01DV-004 has no quality assessment
A Dataset Version cannot be used for training or evaluation until its quality assessment is recorded.
- Affects
- DV-004
- Effect
- Blocks model approval and change authorisation for records that use it.
- BlockerRISK-01RSK-003 residual risk is not accepted
New capture hardware shifts image characteristics away from training data. No accepted residual position is recorded.
- Affects
- RSK-003
- Effect
- Blocks continued operation and change authorisation.
- BlockerRISK-01RSK-005 residual risk is not accepted
Draft progression use case is used clinically before authorisation. No accepted residual position is recorded.
- Affects
- RSK-005
- Effect
- Blocks continued operation and change authorisation.
- BlockerREV-01REV-011 condition is overdue
Close the drift risk RSK-003 with a verified control. Owner Louis Wu, due 2026-06-30.
- Affects
- REV-011
- Effect
- Blocks change authorisation until closed.
- BlockerMON-01Monitoring threshold breached: Sensitivity, northern sites
Observed 0.88 against threshold "Not below 0.92" on 2026-07-01.
- Affects
- AIS-001
- Effect
- Requires an AI Risk assessment and a change or restriction decision.
- BlockerMON-01Monitoring threshold breached: Image statistics drift
Observed 0.21 against threshold "Not above 0.15" on 2026-07-01.
- Affects
- AIS-001
- Effect
- Requires an AI Risk assessment and a change or restriction decision.
- BlockerCE-01PM-003 has no impact assessment
A Planned Modification cannot be authorised or included in a PCCP without one.
- Affects
- PM-003
- Effect
- Excludes the modification from the generated PCCP.
- BlockerREPRO-01MV-004 cannot be reproduced
No commit, environment, hyperparameters or dataset versions are recorded, so the result cannot be re-derived.
- Affects
- MV-004
- Effect
- Blocks continued operation. The deployed result is not evidenced.
- BlockerSIG-01Performance signal not acknowledged: Sensitivity below threshold, northern sites
Sensitivity 0.88 against a floor of 0.92 across four northern sites over the July window. Observed 2026-07-01.
- Affects
- AIS-001
- Effect
- Restriction is proposed. Blocks continued operation until answered.
- BlockerSIG-01Drift signal not acknowledged: Image statistics drift above tolerance
Population drift metric 0.21 against a tolerance of 0.15, coincident with a camera fleet replacement at two sites. Observed 2026-07-01.
- Affects
- AIS-001
- Effect
- Requires triage and a recorded response.
- BlockerUDI-02UDI-DI (01)05412345000041 is not registered
Threshold recalibration for the northern sites. Performance changes, so registration is required before release. A change that affects performance or safety carries a new UDI-DI, and that UDI-DI is registered before the version is placed on the market.
- Affects
- (01)05412345000041
- Effect
- Blocks release of this version.
Warnings
A warning lowers readiness but does not stop a gate.
- WarningSTRUCT-02UC-003 references no AI Model
Use case "Longitudinal progression flag" cannot be traced to a model, so its performance cannot be evidenced.
- Affects
- UC-003
- Effect
- Blocks approval of this use case.
- WarningTRACE-01MV-003 has no training suitability record
No Dataset Model record states which Dataset Version was used for training or why it is suitable.
- Affects
- MV-003
- Effect
- Blocks model approval.
- WarningTRACE-02MV-001 has no testing suitability record
Performance cannot be traced to a specific, immutable Dataset Version.
- Affects
- MV-001
- Effect
- Blocks model approval.
- WarningTRACE-02MV-003 has no testing suitability record
Performance cannot be traced to a specific, immutable Dataset Version.
- Affects
- MV-003
- Effect
- Blocks model approval.
- WarningREV-01REV-011 condition is open
Complete the quality assessment for DV-004 before use in training. Owner Louis Wu, due 2026-08-31.
- Affects
- REV-011
- Effect
- Must be closed before the next periodic review.
- WarningEVID-01DHF-2291-RMR-003 is stale
Approved 2025-02-06. Review interval is 12 months.
- Affects
- DHF-2291-RMR-003
- Effect
- Weakens the mapping that depends on it.
- WarningREPRO-01MV-003 cannot be reproduced
No commit, environment, hyperparameters or dataset versions are recorded, so the result cannot be re-derived.
- Affects
- MV-003
- Effect
- Blocks model approval.
- WarningREPO-01Repository event main has no governance response
Site-level threshold recalibration, northern cohort, Performance changes. Freeze a new AI Model Version, open a change authorisation review, and assign a new UDI-DI.
- Affects
- 4de90c1
- Effect
- Change is happening in the repository ahead of the record set.
- WarningREPO-01Repository event #412 has no governance response
Add second input modality: OCT volumes, Outside the declared Controlled Evolution boundary. Requires a new authorisation and a new Basic UDI-DI.
- Affects
- 77b0aa3
- Effect
- Change is happening in the repository ahead of the record set.
For information
Recorded so nothing is silently dropped.
No findings. Every rule in scope passes.
Nothing to note.