Sample policy · Ophthalmology

Consent for ophthalmic procedures policy (ophthalmology)

Statutory anchor: Regulation 11 (need for consent), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The decision-making and material-risk standard is set by the Mental Capacity Act 2005, the Montgomery v Lanarkshire standard of material risk, and GMC consent guidance. · primary source

1. What the regulation says

Care and treatment of service users must only be provided with the consent of the relevant person. (Reg 11(1): the headline duty)

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/11. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

You can only provide care or treatment with the consent of the relevant person. If the service user is 16 or over and lacks capacity, follow the Mental Capacity Act 2005. If Parts 4 or 4A of the Mental Health Act 1983 apply, follow that instead. Section 5 of the MCA (acts done in connection with care or treatment) still applies underneath.

3. Purpose

Eye surgery is often elective and is chosen by the patient to improve vision, so the patient's understanding and agreement matter as much as the surgery itself. The law on consent expects a patient to be told about the material risks that matter to them and the reasonable alternatives, including doing nothing. This policy sets out how the Service takes informed consent for ophthalmic procedures, with realistic expectations about what vision the patient will have afterwards.

The Service must verify this policy against current GMC consent guidance, the Montgomery standard of material risk, and the Mental Capacity Act before adoption.

4. Scope

This policy applies to:

5. What the patient is told

For each procedure the patient is told, in plain language and in a form they can keep:

Risk information is procedure-specific. For example, cataract surgery covers the risk of posterior capsule rupture, endophthalmitis, retinal detachment, the chance the lens power is not exactly on target, and the likelihood of still needing glasses for some tasks. Intravitreal injection covers endophthalmitis and the need for urgent help if symptoms occur. The Service confirms its risk wording against current Royal College of Ophthalmologists material.

6. Realistic expectations about vision

Because patients choose eye surgery to see better, the Service is clear and honest about the visual result:

7. Two-stage consent and time to decide

For elective and refractive procedures the Service separates the discussion from the day of surgery, so the patient has time to reflect:

8. Capacity and best interests

Where a patient may lack the capacity to decide about a procedure, the Service follows the Mental Capacity Act: capacity is assessed for that decision, all practicable help is given to support the person to decide, and where they cannot, a best-interests decision is made and recorded, involving those close to the person and, where the person has no one to represent them, an independent advocate.

9. Chaperone and dignity

The patient is offered a chaperone for any examination or procedure where one is appropriate, the offer and the patient's choice are recorded, and the patient's dignity and comfort are respected throughout.

10. Recording

The consent discussion, the information given, the patient's questions, the agreed procedure and lens, and the patient's agreement are recorded. The signed consent form is one part of the record, not the whole of it; the record shows that a real discussion took place.

Operational controls to adapt

Roles and responsibilities

Ophthalmic consent procedure

  1. Confirm the exact procedure. Record the eye, procedure, laterality, lens or device where relevant, anaesthetic plan and whether the procedure is elective or urgent.
  2. Check capacity and communication needs. Identify interpreter, accessible-information, advocate, best-interests or representative involvement before the decision is taken.
  3. Explain realistic outcomes. Discuss expected visual benefit, likely need for glasses or further treatment, limits of the procedure, and what happens if the patient chooses no treatment.
  4. Discuss material risks. Cover risks that matter to this patient and procedure, including sight-threatening complications and the chance of further surgery or treatment.
  5. Give time to decide. For elective procedures, keep the consent discussion separate from the procedure date unless a clinical reason is recorded.
  6. Confirm the patient still agrees. Reconfirm consent on the day of the procedure and pause if the patient is unsure, distressed or asks new questions.
  7. Link consent to theatre checks. The consent form, procedure booking, eye marking and surgical safety checklist must all match before the procedure starts.
  8. Escalate exceptions. Missing consent, wrong-eye uncertainty, capacity concerns, safeguarding concerns, complaints or alleged pressure are escalated to the clinician in charge and opened on the relevant register.

Records and register links

The consent record should include:

Consent gaps and wrong-eye concerns are opened on the incident register. Repeated documentation gaps are added to the risk register or improvement-actions register and reviewed at governance.

Training and competence

Clinicians who take consent must keep evidence of competence in consent, material-risk discussions, capacity assessment, procedure-specific risks and communication adjustments. Staff who support the pathway receive training on approved patient information, reflection periods, escalation and what they must not explain beyond their role.

11. Audit cadence

The Service checks, on a stated cadence, that:

The Registered Manager and the clinical lead 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, consent procedure, record fields, register links, training 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.

Eye surgery is usually elective, chosen by a person who can already see something, and the intraocular lens fitted at cataract surgery is not easily swapped once it is in place, so the quality of the conversation protects the patient far more than the signature does. The distinctive hazard is the expectation gap. A patient told they would be free of glasses, who then sees haloes on a night drive, has had a technically successful operation and a disappointing outcome, and that is where most complaints in this specialty begin. A second hazard is practical. Consent is often reconfirmed in the pre-operative area after the pupils have been dilated, at the point where the person can no longer comfortably read the form they are being asked to sign, so anything first raised there is not genuinely being agreed to. Because there are two eyes and a chosen lens power, the consent record doubles as a safety document: it is what the theatre team holds the booking, the eye marking and the checklist against, and a mismatch found there should stop the case rather than be talked away. A record that captures the person's own visual goals, the trade-offs of the lens they chose and the moment they reconfirmed gives them a fair basis on which to judge their own result, and gives the team a way to catch the wrong eye before anyone touches it.

  1. The consent record shows procedure-specific material risks, benefits and reasonable alternatives (including doing nothing) tailored to this patient's eyes, occupation and lifestyle, not a generic signed form. The signed form is only one part of the record, and what matters to the patient is that a real discussion took place and can be seen in the notes.

    Strong evidence: The audit that consent records show procedure-specific risks, benefits and alternatives, not a generic form; the recording section, where the signed consent form is one part of the record and the record must show a real discussion took place.

    Weak evidence: A pre-printed form headed with the procedure name, the same tick-list of risks on every record, and a free-text box left blank or filled with "risks and benefits explained". Nothing shows what mattered to this patient: no note of the occupation, driving need or hobby that makes a particular risk material to them, no record of the alternatives discussed such as glasses, contact lenses or watchful waiting, and no sign that doing nothing was ever put on the table.

    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. An elective procedure has time between the consultation and the day of surgery, with consent confirmed (not first taken) on the day, so the patient has room to reflect and change their mind. Any same-day exception is justified by a recorded clinical reason, not a patient signed up and operated on in one visit.

    Strong evidence: The audit that elective procedures had time between the consultation and the day of surgery; the two-stage consent section separating the discussion from the procedure date and confirming, not first taking, consent on the day.

    Weak evidence: A run of records where the consultation date and the surgery date are the same, with the consent form signed in the pre-operative area and no earlier discussion note behind it. Same-day cases are explained by "patient wished to proceed today" rather than a recorded clinical reason, and the take-away information leaflet is logged without a version or date, so the service cannot show what the patient was actually given to read or when they had a chance to read it.

    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.

  3. The patient is given realistic vision expectations before the lens choice, including whether they will still need glasses and the trade-offs of a multifocal or toric lens (glare, haloes, reduced contrast), not a promise of spectacle-free vision unless that is realistic for them.

    Strong evidence: The realistic-expectations section on target refraction and lens trade-offs explained before the choice; the consent record capturing patient-specific goals, expected visual benefit and likely need for glasses.

    Weak evidence: The record notes the lens model and power but says nothing about target refraction or whether the patient should still expect to wear glasses for distance or near. A multifocal or toric lens is selected with no note that glare, haloes or reduced contrast were explained before the choice was made, and the first written mention of what the patient expected appears in the complaint file after they are unhappy with the result.

    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. Where a patient may lack capacity for the decision, capacity is assessed for that specific decision under the Mental Capacity Act 2005, practicable support to decide is given, and a best-interests decision is recorded involving those close to the person or an independent advocate where they have no one, not a relative signing on their behalf.

    Strong evidence: The audit that capacity assessments and best-interests records are present where needed; the capacity-and-best-interests section following the Mental Capacity Act 2005.

    Weak evidence: A relative's signature on the consent form with no capacity assessment behind it, or a blanket line such as "patient has dementia, daughter consented". Capacity recorded once at registration and reused for the surgical decision, no note of what practicable support was tried to help the person decide for themselves, best-interests records that name no one consulted, and no independent advocate involved where the person has nobody close to them.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Mental Capacity Act 2005 ss.1(3), 2(1), 3 and 4 (in particular s.4(7)); Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 11(3)

  5. The consent form, procedure booking, eye marking and surgical safety checklist all match before the procedure starts, so a consent or laterality mismatch stops the case rather than being reconciled in theatre.

    Strong evidence: The consent-procedure step requiring the consent form, booking, eye marking and surgical safety checklist to match before the procedure starts; the consent record confirming that consent, booking, eye marking and checklist matched.

    Weak evidence: A checklist completed in one sweep, every box in the same pen and the same hand, signed after the patient is already draped. Eye marking is recorded but nothing shows anyone held it against the consent form and the theatre booking, and where a mismatch was found it was sorted out verbally in theatre and never opened on the incident register, so the near miss leaves no trace and the barrier that nearly failed is never examined.

    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.

  6. A chaperone is offered for any examination or procedure where one is appropriate, and the patient's choice is recorded, not assumed.

    Strong evidence: The audit that chaperone offers are recorded; the chaperone-and-dignity section recording the offer and the patient's choice.

    Weak evidence: A chaperone poster in the waiting area but no field in the clinical record, or a template with "chaperone offered" already ticked before the clinician sits down. Declines never appear anywhere, so the service can only evidence the occasions a chaperone was accepted, and there is no record of who acted as chaperone or that they were present for the examination itself.

    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.

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Last verified 20 July 2026

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Last reviewed 10 June 2026