Visual outcomes and complications audit policy (ophthalmology)

1. What the regulation says

Systems or processes must be established and operated effectively to ensure compliance with the requirements in this Part. (Reg 17(1): the umbrella duty)

assess, monitor and improve the quality and safety of the services provided in the carrying on of the regulated activity (including the quality of the experience of service users in receiving those services) ... assess, monitor and mitigate the risks relating to the health, safety and welfare of service users and others who may be at risk which arise from the carrying on of the regulated activity. (Reg 17(2)(a) and (b): quality and risk)

maintain securely an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided to the service user and of decisions taken in relation to the care and treatment provided. (Reg 17(2)(c): accurate service-user record)

Regulation 12 adds the safe-care duties this policy operationalises:

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

The full text is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/17 and https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

You have to run effective systems and processes to comply with everything else in Part 3. The regulation lists six things those systems must enable in particular: quality assessment and improvement, risk management, accurate service-user records, accurate employment and management records, seeking and acting on feedback, and continually evaluating and improving how you process all this. If CQC requests a written report on quality and risk plus your improvement plans, you have 28 days from the day after the request.

Regulation 12 requires that care and treatment is provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Auditing the visual outcomes and complications of the procedures the service performs is how the service evidences both the quality-and-risk monitoring duty under Regulation 17 and the safe-care duty under Regulation 12.

3. Purpose

Ophthalmology is one of the most measurable parts of medicine: the vision a patient ends up with, how close the lens power landed to target, and the rate of complications can all be counted and compared against national figures. A service that measures its own results, compares them honestly and acts on outliers is a well-led service. This policy sets out how the Service audits its visual outcomes and complications and uses them to improve.

The Service must verify this policy against current Royal College of Ophthalmologists audit standards and benchmarks before adoption.

4. Sources to verify before adoption

• Royal College of Ophthalmologists, National Ophthalmology Database audit and cataract outcome benchmarks: https://www.rcophth.ac.uk/
• Getting It Right First Time (GIRFT) ophthalmology: https://gettingitrightfirsttime.co.uk/
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 17 (good governance) and Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/17

5. Scope

This policy applies to:

• the outcomes and complications of the procedures the Service performs, including cataract surgery, intravitreal injection, laser and minor surgery
• the surgeons and clinicians who perform them
• the clinical governance process that reviews the results

6. What the Service measures

The Service agrees and records the measures relevant to the procedures it offers. For cataract surgery these typically include:

• the rate of posterior capsule rupture or vitreous loss
• visual acuity outcomes, including the proportion achieving a good corrected and uncorrected acuity
• refractive accuracy, meaning the proportion of eyes within a stated range of the target refraction
• the endophthalmitis rate
• other complication rates, such as retinal detachment, cystoid macular oedema, or a return to theatre

For intravitreal injection the measures include the endophthalmitis rate and other injection-related complications. The Service confirms its measures and the way it defines them against current Royal College of Ophthalmologists standards, so its figures can be compared.

7. Benchmarking and per-surgeon results

• the Service compares its results against current national benchmarks, not only against itself over time
• results are reviewed by surgeon as well as for the service as a whole, because an aggregate figure can hide an individual outlier
• the Service holds enough data per surgeon to make a fair comparison, and is careful about case-mix, so a surgeon who takes on more complex cases is judged fairly

8. Acting on outliers and unexpected outcomes

• where a surgeon's or the service's results sit outside the expected range, the Service looks into why, supportively and promptly, rather than waiting for the next annual review
• an unexpected individual outcome, such as a large refractive surprise or a serious complication, is reviewed at the time, with the lens calculation, the biometry and the technique checked
• where a problem is found, the Service acts: this may mean a change to practice, additional training or supervision, a change of equipment or technique, or a pause while the cause is understood
• support for a clinician whose results are an outlier is handled fairly and follows the Service's people and appraisal processes

9. Patient-reported outcomes

The Service seeks the patient's own view of the result where it can, because the number on the chart is not the whole story. Patient-reported outcomes and feedback are reviewed alongside the clinical measures.

10. Recording and governance

• outcome and complication data is recorded accurately and kept up to date
• the data is reviewed at the clinical governance meeting on a stated cadence, with attendance and decisions recorded
• learning that warrants a change produces improvement actions, tracked to completion with evidence
• serious complications are also logged as patient-safety incidents and run through the incident process, so single events and patterns are both seen

Operational controls to adapt

Roles and responsibilities

• Registered Manager: owns the outcomes-audit system and makes sure findings lead to action.
• Clinical lead or lead surgeon: defines the measures, reviews per-procedure and per-clinician results, and escalates outliers or unexpected harm.
• Operating clinicians: record outcome, complication and follow-up data accurately and take part in peer review.
• Audit or governance lead: prepares the audit, checks data completeness, records decisions and tracks improvement actions.
• Administration team: supports follow-up capture, patient-reported outcome collection and missing-data chasing.

Outcomes and complications audit procedure

1. Define the measure set. Name the outcomes, complications, case-mix factors and follow-up points for each procedure offered.
2. Capture data at source. Record planned outcome, baseline measure, procedure detail, clinician, complication and follow-up result in the clinical record or audit log.
3. Check data completeness. Chase missing follow-up, missing complications and missing patient-reported outcome information.
4. Review results by procedure and clinician. Compare actual outcomes with the Service's expected range, published benchmark or local historical data.
5. Investigate outliers. Review unexpected complications, poor visual outcomes, repeat outliers and patient complaints through peer review or external advice.
6. Act on findings. Record decisions, patient follow-up, training, equipment, pathway or consent changes, and assign improvement actions.
7. Share learning. Discuss themes at governance and feed relevant learning into consent wording, surgical safety checks and patient information.

Records and register links

The outcomes-audit record should include:

• procedure type, clinician, case-mix notes and denominator
• baseline measure, intended outcome and follow-up result
• complication, return-to-theatre, infection, unexpected admission or urgent referral
• patient-reported outcome or satisfaction result where collected
• missed follow-up, data-completeness issue and chasing action
• peer-review or external-review decision
• risk entry, incident, complaint, audit finding or improvement action

Serious or unexpected complications are opened on the incident register. Outlier trends, poor follow-up capture and recurring documentation gaps are tracked through the risk register and improvement-actions register.

11. Audit cadence

The Service checks, on a stated cadence, that:

• the agreed outcome and complication measures are being collected and defined consistently
• results are benchmarked against national figures and reviewed by surgeon as well as overall
• outliers and unexpected outcomes are investigated promptly and acted on
• improvement actions from outcome review are completed with evidence

The Registered Manager and the lead surgeon review the results and record the improvement actions that follow.

12. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 17: Good governance
• CQC Regulation 12: Safe care and treatment
• CQC assessment framework and sector-specific guidance, as updated by CQC from time to time
• NICE guidance and professional standards relevant to clinical audit
• Royal College of Ophthalmologists (RCOphth) guidance and National Ophthalmology Database audit and cataract outcome benchmarks
• Getting It Right First Time (GIRFT) ophthalmology
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/17)

Related reading

• Related policy: Surgical safety checklist policy
• Related policy: Consent for ophthalmic procedures policy
• Related policy: Intravitreal injection safety policy
• Related policy: Action Plan and Improvement Tracking Policy

13. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

14. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.