Consent for ophthalmic procedures policy (ophthalmology)

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:

• every ophthalmic procedure the Service offers, including cataract surgery, refractive and laser surgery, intravitreal injection and minor oculoplastic surgery
• the clinicians who take consent and the staff who support the process
• adults with capacity, adults who may lack capacity for the decision, and (where in scope) children

5. What the patient is told

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

• what the procedure is and what it is for
• the realistic benefit, and that an improvement is not guaranteed
• the material risks, including those that matter to this particular patient given their eyes, occupation and lifestyle
• the reasonable alternatives, including glasses, contact lenses, watchful waiting or doing nothing, and the likely outcome of each
• what recovery involves and what restrictions apply afterwards

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:

• the target refraction is explained, and whether the patient should still expect to wear glasses for distance, near or both
• where a particular lens choice (for example a multifocal or toric lens) carries trade-offs such as glare, haloes or reduced contrast, these are explained before the choice is made
• the patient is not given an expectation of perfect or spectacle-free vision unless that is a realistic outcome for them

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:

• consent is discussed at an earlier consultation, the patient is given written information to take away, and consent is confirmed (not first taken) on the day
• the patient is told they can change their mind at any point up to the procedure, without pressure
• the Service does not rush a patient into an elective procedure on the same day as the first consultation

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

• Registered Manager: owns this policy, makes sure the consent pathway is followed, and reviews consent incidents, complaints and audit findings.
• Operating clinician: leads the consent discussion, confirms capacity and communication needs, explains procedure-specific risks and alternatives, and records the decision.
• Booking or pathway team: gives only approved information, checks the reflection period and consent documents are complete, and escalates missing consent, uncertainty or patient pressure concerns.
• Governance lead: reviews consent records, complaints, complications and improvement actions through the clinical governance meeting.

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:

• eye, procedure, lens or device where relevant, anaesthetic plan and procedure date
• patient-specific goals, concerns, material risks, benefits, alternatives and no-treatment option
• information leaflet or digital resource given, including version or date
• capacity, interpreter, advocate, accessible-information or best-interests decision where relevant
• reflection period, same-day exception or urgent clinical reason
• questions asked by the patient and answers given
• confirmation that consent, booking, eye marking and checklist matched
• complaints, incidents, safeguarding concerns, risk entries or improvement actions linked to the consent process

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:

• consent records show procedure-specific risks, benefits and alternatives, not a generic form
• elective procedures had time between the consultation and the day of surgery
• capacity assessments and best-interests records are present where needed
• chaperone offers are recorded

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.

• CQC Regulation 11: Need for consent (https://www.legislation.gov.uk/uksi/2014/2936/regulation/11)
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/contents/made)
• Mental Capacity Act 2005 (https://www.legislation.gov.uk/ukpga/2005/9/contents) and the MCA Code of Practice (2007, update in consultation)
• Montgomery v Lanarkshire Health Board [2015] UKSC 11; GMC Decision making and consent guidance
• GMC, Decision making and consent (https://www.gmc-uk.org/professional-standards/professional-standards-for-doctors/decision-making-and-consent)
• Royal College of Ophthalmologists, procedure-specific consent and patient-information material (https://www.rcophth.ac.uk/)
• Gillick and Fraser competence where children are in scope
• Human Rights Act 1998 (Article 8) where relevant
• CQC assessment framework and sector-specific guidance, as updated by CQC from time to time

Related reading

• Related policy: Correct patient, correct eye, correct lens policy
• Related policy: Surgical safety checklist policy
• Related policy: Consent and shared decision-making policy
• Regulation explainer: Regulation 12 safe care and treatment

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.