Correct patient, correct eye, correct lens policy (ophthalmology)

1. What the regulation says

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))

ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))

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

2. Plain-English summary

Care and treatment must be 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. Regulation 12 is central to CQC's safety expectations. Wrong-site surgery, wrong implant and wrong-power lens implantation are serious, largely preventable patient-safety incidents (recognised as Never Events in NHS-funded care), and preventing them is part of the reasonable-practicable risk mitigation that Regulation 12 requires.

3. Purpose

In ophthalmology the two eyes look alike, the procedure is often on one eye only, and for cataract surgery a lens of a specific power is chosen for that one eye. Operating on the wrong eye, implanting the wrong intraocular lens, or implanting a lens of the wrong power are serious, largely preventable patient-safety incidents. Where NHS-funded care or NHS contract requirements apply, they fall within the NHS England Never Events framework. In all other cases the Service treats them with equivalent seriousness. This policy sets out the checks the Service runs, from listing to the moment of surgery, so that the right patient has the right procedure on the right eye with the right lens.

The Service must verify this policy against the current NHS England Never Events list, the National Safety Standards for Invasive Procedures (NatSSIPs) and Royal College of Ophthalmologists guidance before adoption.

4. Sources to verify before adoption

• NHS England, Never Events list (wrong site surgery, wrong implant/prosthesis): https://www.england.nhs.uk/patient-safety/never-events/
• National Safety Standards for Invasive Procedures (NatSSIPs): https://www.england.nhs.uk/patient-safety/natssips/
• Royal College of Ophthalmologists, cataract surgery guidelines and Ophthalmic Services Guidance: https://www.rcophth.ac.uk/
• NICE NG77, Cataracts in adults: management: https://www.nice.org.uk/guidance/ng77
• WHO Surgical Safety Checklist (adapted for ophthalmic surgery)
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12

5. Scope

This policy applies to:

• every procedure on one or both eyes, including cataract surgery, intravitreal injection, laser, and minor oculoplastic surgery
• the selection and implantation of intraocular lenses
• everyone involved: the listing clinician, the booking team, the operating surgeon, the scrub and theatre team, and the person performing each check

A second eye is never assumed to need the same procedure or the same lens as the first.

6. Roles and responsibilities

• Registered Manager: owns governance of the pathway, makes sure local procedures, competent staffing and audit are in place, and reviews incidents, near misses and overdue actions.
• Lead surgeon or clinical lead: approves the local invasive-procedure standard, resolves pathway design questions and leads clinical review after a mismatch or event.
• Listing clinician: records the intended procedure, eye and clinical indication at source, and makes sure ambiguity is resolved before the case reaches booking.
• Booking and pre-assessment staff: transfer the source information without changing it, flag discrepancies and make sure biometry, consent and planned-lens information are available for review.
• Operating surgeon: confirms the patient, eye, procedure and planned lens, leads the team pause and does not delegate the final decision to proceed.
• Scrub practitioner and theatre team: complete independent checks, read the lens details from the package and plan, record the implant and use stop-the-line authority whenever information does not match.

7. Step-by-step pathway from listing to sign out

1. Create the source plan. Record the patient, procedure, operative eye, indication and any planned implant in the clinical record at listing.
2. Transfer the plan to booking. Booking staff compare the request with the source record and return any unclear, incomplete or conflicting instruction to the listing clinician.
3. Complete eye-specific assessment. Link biometry, calculation, target refraction, consent and lens choice to the correct eye. Keep right-eye and left-eye information visibly distinct.
4. Confirm on admission. Use approved patient identifiers, ask the patient to state the procedure and eye where possible, compare this with the record and consent, and resolve any difference before preparation.
5. Mark and prepare the operative eye. Apply the approved mark while the patient can participate, then confirm the prepared and draped eye matches it.
6. Run the team pause and lens check. The whole team confirms identity, eye, procedure and lens details aloud. Two people independently check the selected lens against the current plan.
7. Sign out and reconcile. Record the procedure and implant used, account for any change from plan, complete traceability and escalate a mismatch, near miss or missing record before the patient leaves the pathway.

8. Marking and confirming the operative eye

• The operative eye is confirmed against the source of truth (the clinical record and the consent form) and marked before the patient enters the operating area, while the patient is awake and able to confirm it.
• The mark is an arrow or initials placed near the eye to be operated on, by a member of the operating team, using a marker that survives skin preparation.
• The patient (or, where the patient cannot confirm, their representative) is asked to state which eye is being treated; the team confirms this matches the record, the consent and the mark. A mismatch stops the process until it is resolved.
• Where marking the eye itself is not practical, the Service records the alternative it uses and how the operative side is still positively confirmed.

9. The intraocular lens: power, type and second check

For any procedure implanting an intraocular lens (IOL):

• the lens power is calculated for the correct eye from that eye's biometry, and the calculation, the formula used and the target refraction are recorded
• the planned lens (power, model and type, including toric axis where relevant) is documented in the operative plan and on the consent form
• before implantation, two team members independently confirm that the lens taken from stock matches the plan for that eye, reading the power, model and, for toric lenses, the axis aloud
• any change to the planned lens during surgery (for example a switch of model or power) is verbalised, agreed and recorded, and triggers a fresh two-person check

10. The three-point check at surgery

The team runs a checklist, based on the WHO Surgical Safety Checklist adapted for ophthalmic surgery, at three points:

1. Before the patient enters the operating area (sign in): identity confirmed against the record using at least three identifiers; the operative eye confirmed and marked; the consent confirmed; the planned procedure and lens confirmed; allergies and anticoagulation reviewed.
2. Before the procedure starts (time out): the whole team pauses; identity, eye, procedure, consent and the lens (power, model, axis) are confirmed aloud against the record; the team confirms the marked eye is the eye prepared and draped.
3. Before the patient leaves (sign out): the procedure performed, the lens implanted (recorded by power, model and serial or lot number), any change from plan, and any concern are recorded.

The check is a genuine pause. It is not signed retrospectively.

11. Stop-the-line authority

Any member of the team can and must stop the process at any point if the eye, the patient, the consent or the lens does not match. Stopping is expected and supported, and is never treated as obstructive. The procedure does not continue until the discrepancy is resolved and recorded.

12. When something goes wrong

If a wrong-eye, wrong-lens or wrong-power event occurs or is narrowly avoided:

• the patient's immediate safety is managed and senior clinical help is sought
• the event is logged the same day as a patient-safety incident and runs through to a recorded outcome with completed actions
• where NHS-funded care or NHS contract requirements apply, a wrong-eye, wrong-procedure, wrong-implant or wrong-lens event that reaches the patient may fall within the Never Events framework. In all other cases, the Service treats such an event with equivalent seriousness as a serious patient-safety incident, with duty of candour, investigation, notification assessment and corrective action
• a near miss is reviewed with the same seriousness, because it shows the barriers nearly failed

13. Training

Everyone involved in listing, booking, marking or operating completes, at induction and on a refresher cadence the Service sets, training in: the marking and confirmation procedure, the IOL two-person check, the adapted surgical safety checklist, and stop-the-line authority. The Service records completion and the next refresher date.

14. Audit cadence

The Service checks, on a stated cadence, that:

• every operative eye was marked and confirmed before surgery, with the patient's involvement recorded
• every implanted lens has a recorded two-person check matching the plan, with power, model, axis and serial or lot number captured
• the three-point checklist was completed in real time for every case
• every wrong-eye / wrong-lens event or near miss was reported, investigated and learned from, with actions completed

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

15. Links to registers and action tracking

• A mismatch, wrong-site event, wrong-implant event and near miss is logged in the incident register on the day it is identified.
• Recurring booking, biometry, stock, labelling, handover or checklist weakness is considered for the risk register even when no patient was harmed.
• Duty-of-candour and external-reporting decisions are linked to the incident record with the source checked and decision-maker named.
• Competency gaps and restrictions are entered in the training matrix before the person returns to the affected task.
• Investigation and audit actions have owners, due dates and evidence of completion, and governance verifies whether the changed control works.

16. Related policies in this pack

• Ophthalmology surgical safety checklist policy
• Consent for ophthalmic procedures policy
• Visual outcomes and complications audit policy
• Incident reporting, investigation and learning policy
• Training, competency and mandatory training policy

17. 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 12: Safe care and treatment
• CQC Fundamental Standards
• NHS England, Never Events list (wrong site surgery, wrong implant/prosthesis)
• National Safety Standards for Invasive Procedures 2 (NatSSIPs 2) and local equivalents (LocSSIPs)
• Royal College of Ophthalmologists (RCOphth) guidance, including cataract surgery guidelines and Ophthalmic Services Guidance
• NICE NG77, Cataracts in adults: management
• WHO Surgical Safety Checklist (adapted for ophthalmic surgery)
• Never-event learning resources and relevant NHS Patient Safety Alerts / CAS alerts
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)

18. 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.

19. Document control

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