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

1. 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 recognised Never Events: serious, largely preventable patient-safety incidents. 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.

2. 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

3. 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.

4. 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.

5. 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

6. 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.

7. 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.

8. 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
• a wrong-site, wrong-implant or wrong-power event that reaches the patient is treated as a Never Event: the duty of candour is opened, the patient is told what happened, and the event is notified and investigated under the Service's serious-incident process
• a near miss is reviewed with the same seriousness, because it shows the barriers nearly failed

9. 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.

10. 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.