Sample policy · Ophthalmology

Visual outcomes and complications audit policy (ophthalmology)

Statutory anchor: Regulation 17 (good governance), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). This policy also engages Regulation 12 (safe care and treatment). · primary source

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

5. Scope

This policy applies to:

6. What the Service measures

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

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

8. Acting on outliers and unexpected outcomes

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

Operational controls to adapt

Roles and responsibilities

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:

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 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.

Related reading

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

Version Date Author Changes
v1.1 2026-07-14 Verivius (sample) Added role ownership, outcomes-audit procedure, record fields, register links and related reading.
v1 2026-06-10 Verivius (sample) Initial sample template, conformed to the Verivius policy standard.

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.

What good looks like here

Written from an ex-CQC inspector's chair, but the point is safe, well-led care your team can stand behind. Each row shows what strong evidence looks like, what thin evidence looks like, and where the expectation comes from.

Cataract and intravitreal work is high volume and mostly uneventful, which is exactly why a drifting result hides so well: a surgeon whose posterior capsule rupture rate or refractive accuracy has slipped will still have a clinic full of patients who say they are fine. The harm arrives one person at a time, in the patient told they would not need glasses for distance who now does because the lens power landed off target, or in the rare case of endophthalmitis that only reads as a pattern once somebody counts. Eye surgery is unusually measurable, so biometry targets, acuity and complication rates can all be compared against national figures, which means a service that cannot produce honest per-surgeon numbers with a real denominator does not actually know how well its patients are doing. Chasing missing follow-up is not administrative tidiness: an audit that quietly loses the patients who never came back flatters the very rates the service relies on to decide whether it is safe to keep operating the same way. Getting this right is what lets a service change a lens constant, a technique or a consent conversation before the next list, rather than after the next complaint.

  1. Results are broken down by surgeon as well as reported for the service as a whole, because an aggregate figure can hide an individual outlier whose patients are quietly doing worse. There is enough data per surgeon to make a fair comparison, and case-mix is handled honestly, so a surgeon who takes on more complex cases is judged fairly.

    Strong evidence: Results reviewed by surgeon as well as for the service as a whole, with enough data per surgeon and case-mix noted, and the record's procedure type, clinician, case-mix notes and denominator.

    Weak evidence: One service-wide figure on a governance slide, such as a single posterior capsule rupture rate, with no breakdown by the surgeon who operated. Or a per-surgeon table built on a handful of cases for an occasional operator and presented as if it were comparable, with case-mix handled by a one-line footnote saying the service takes complex patients rather than a record of which cases were dense, post-vitrectomy, small-pupil or highly myopic.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  2. The service compares its outcomes against current national benchmarks, not just against itself over time, and defines its measures the way the benchmark defines them, so the comparison means something.

    Strong evidence: The audit-cadence check that the agreed outcome and complication measures are collected and defined consistently and benchmarked against national figures, not only against the service's own history.

    Weak evidence: The audit compares this year with last year and stops there, so a rate that has been quietly poor for three years still looks stable. Or a national figure is quoted with no source and no date, and the local measure is defined differently from the benchmark it is set against, for example refractive accuracy scored against an in-house target range rather than the range the benchmark uses, which makes the comparison look reassuring without meaning anything.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  3. A real outlier or unexpected outcome is investigated at the time, with the lens calculation, the biometry and the technique checked, rather than parked to the annual review, and it leads to a recorded action. That is what lets something change before the next operating list rather than after the next complaint.

    Strong evidence: The peer-review or external-review decision and the linked risk entry, incident or improvement action, and the audit check that outliers and unexpected outcomes are investigated promptly and acted on.

    Weak evidence: A large refractive surprise or a case of endophthalmitis sits as a spreadsheet row and is first discussed at the annual audit meeting months later. Nothing on file shows the biometry printout, the lens constant or the formula used were rechecked at the time, and the recorded action reads "surgeon aware" or "discussed informally", with no owner, no date and nothing linking it to a risk entry or improvement action.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  4. Learning that warrants a change produces a tracked improvement action closed with evidence, discussed at governance with attendance and decisions recorded, so whoever picks the action up next can see what was agreed and whether it was done, rather than it being noted and forgotten.

    Strong evidence: Data reviewed at the clinical governance meeting on a stated cadence with attendance and decisions recorded, and improvement actions tracked to completion with evidence.

    Weak evidence: Minutes that say "outcomes data reviewed, no concerns" with no attendance list and no decision recorded, so nobody can tell who was in the room or what was agreed. Or an action such as "review lens constants" carried open through three consecutive meetings with no owner, no completion evidence and nothing showing what actually changed on the operating list.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  5. A serious or unexpected complication is not only counted in the audit but also opened as a patient-safety incident, so the harm to one person and the pattern behind it are both seen.

    Strong evidence: Serious or unexpected complications opened on the incident register, with the record's complication, return-to-theatre, infection, unexpected admission or urgent-referral fields.

    Weak evidence: A return to theatre or a case of endophthalmitis is counted in the audit denominator but has no matching entry on the incident register, so the incident log holds only slips, trips and equipment faults while the real clinical harm lives in a spreadsheet. Or the incident is opened weeks later to tidy up the record, with nothing showing whether the complication met the notifiable safety incident threshold that applies to this provider's type and so engaged the Regulation 20 duty of candour owed to the person, which neither counting it in the audit nor opening it on the incident register discharges, and, where it was engaged, what was said to the person and when.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  6. Missing follow-up, missing complications and missing patient-reported outcomes are chased, because incomplete data flatters the rates. The denominator behind each figure is honest, so the patients who did not come back are counted rather than quietly dropped.

    Strong evidence: The record's missed-follow-up and data-completeness fields and the chasing action taken to close them.

    Weak evidence: Follow-up capture running well below full and reported without comment, with the patients who did not come back silently dropped from the denominator rather than chased, which quietly improves every rate on the page. Or patient-reported outcome collection that stopped when the administration team got busy and nobody noticed for months, with no record of who chased what, when, or what remains outstanding.

    Our recommended baseline. Not a legal or regulatory requirement, but a sensible standard we suggest where the rules leave the detail to you. Adapt it to your service.

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Last verified 20 July 2026

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Last reviewed 10 June 2026