Surgical safety checklist policy for ophthalmic day surgery (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))

ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and is used in a safe way, (Reg 12(2)(e) (equipment safety))

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.

3. Purpose

Most eye surgery is day surgery under local anaesthetic, with a high turnover of similar cases. That pattern is efficient, but it is exactly where a routine slip can cause harm. A surgical safety checklist makes the whole team pause and confirm the key facts together before each case. This policy sets out how the Service runs that checklist for ophthalmic day surgery, alongside the eye and lens checks in the correct patient, correct eye, correct lens policy.

The Service must verify this policy against the WHO Surgical Safety Checklist, the National Safety Standards for Invasive Procedures and Royal College of Ophthalmologists guidance before adoption.

4. Sources to verify before adoption

• WHO Surgical Safety Checklist (adapt the standard checklist for ophthalmic surgery): https://www.who.int/teams/integrated-health-services/patient-safety/research/safe-surgery
• National Safety Standards for Invasive Procedures (NatSSIPs): https://www.england.nhs.uk/patient-safety/natssips/
• Royal College of Ophthalmologists, Ophthalmic Services Guidance: https://www.rcophth.ac.uk/
• 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
• The Service's correct patient, correct eye, correct lens policy

5. Scope

This policy applies to:

• every surgical and invasive ophthalmic procedure, including cataract surgery, laser, and minor oculoplastic surgery
• the whole theatre team: surgeon, anaesthetist or sedationist where used, scrub and circulating staff, and recovery staff
• the day-surgery pathway from arrival to discharge

6. The team and the genuine pause

The checklist works only if the whole team stops and takes part. The Service expects:

• every member of the team to be present and listening for each check
• the checks to be read and answered aloud, not signed in advance or in retrospect
• any member of the team to raise a concern at any point, with that concern always welcomed and acted on before the case continues

7. The three phases of the checklist

The checklist is adapted from the WHO Surgical Safety Checklist for ophthalmic surgery and run at three points:

1. Sign in (before the patient enters the operating area): identity confirmed; operative eye confirmed and marked (per the correct patient, correct eye, correct lens policy); consent confirmed; procedure and lens confirmed; allergies checked; anticoagulant and antiplatelet medicines reviewed; anaesthetic plan and any known difficulty confirmed; the required equipment and the correct intraocular lens confirmed as present.
2. Time out (before the procedure starts): the team pauses; each member is known by name and role; identity, eye, procedure, consent and lens are confirmed against the record; the marked eye is confirmed as the eye prepared and draped; any anticipated problem is shared.
3. Sign out (before the patient leaves the operating area): the procedure performed and the lens implanted are recorded (with power, model and serial or lot number); instrument, swab and sharps accounts are correct; any complication or change from plan is recorded; the recovery and discharge plan, including follow-up and who to contact, is confirmed.

8. Local anaesthetic and sedation safety

Because most cases use local anaesthetic, sometimes with sedation, the Service:

• confirms the anaesthetic plan and any allergy or contraindication at sign in
• monitors the patient appropriately during the procedure for the technique used
• keeps resuscitation equipment and trained staff immediately available, and follows the medical emergency and anaphylaxis arrangements
• where sedation is used, applies its sedation safety arrangements (assessment, monitoring, recovery and discharge)

9. Recovery and discharge

Day surgery is safe only if discharge is safe. Before the patient leaves the Service confirms:

• the patient meets the agreed discharge criteria and is accompanied where required
• the patient has clear written aftercare advice, including the eye drops to use, activity restrictions, the symptoms that need urgent help, and exactly how to reach urgent help, including out of hours
• the follow-up appointment and any onward arrangements are in place and recorded

10. When the checklist fails or a complication occurs

If a step is missed, a concern is overruled, or a complication occurs, 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-implant or retained-item event 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, opening the duty of candour and the serious-incident process.

Operational controls to adapt

Roles and responsibilities

• Registered Manager: owns the surgical-safety system and makes sure checklist failures, incidents and audit findings are reviewed.
• Operating surgeon: confirms patient, eye, procedure, consent, implant or lens, anaesthetic plan, anticipated risk and stop-the-line response.
• Theatre or procedure lead: leads the checklist pause, makes sure every team member can speak, and records completion and exceptions.
• Scrub, circulating and recovery staff: complete equipment, implant, count, allergy, infection-prevention and recovery checks within their role.
• Governance lead: reviews checklist compliance, complications, retained-item concerns, wrong-site risks and improvement actions.

Surgical safety checklist procedure

1. Prepare before the list. Confirm procedure list, equipment, sterile instruments, implants, lens powers, emergency equipment, staffing and patient notes.
2. Run sign in. Before the patient enters the operating area, confirm identity, eye, consent, procedure, allergies, medicines risk, anaesthetic plan and equipment readiness.
3. Run time out. Before the procedure starts, the whole team pauses and confirms patient, eye, procedure, consent, implant or lens, marking, anticipated risks and infection-control requirements.
4. Maintain stop-the-line authority. Any team member must stop the list if the patient, eye, lens, consent, equipment, count or safety information does not match.
5. Run sign out. Before the patient leaves, record procedure performed, implant or lens details, counts, complications, specimens, medicines given and follow-up plan.
6. Escalate exceptions. Checklist omissions, wrong-eye risk, wrong-lens risk, failed counts, retained-item concerns or unexpected deterioration are opened on the incident register.
7. Review learning. Audit findings and incidents are reviewed at governance and turned into improvement actions.

Records and register links

The surgical-safety record should include:

• sign-in, time-out and sign-out completion, including who led each pause
• patient identifiers, procedure, eye, consent, mark and implant or lens confirmation
• allergy, anticoagulant, anaesthetic, equipment, count and infection-prevention checks
• stop-the-line concerns and how they were resolved
• complication, failed count, wrong-site concern or unexpected deterioration
• recovery and discharge instructions, follow-up and safety-netting
• incident, duty-of-candour record, risk entry or improvement action

Checklist failures and complications are opened on the incident register. Repeated missed checklist steps are tracked through the risk register and improvement-actions register.

11. Training

Everyone in the theatre and recovery team is trained in the checklist, their role in it, and stop-the-line authority, at induction and on a refresher cadence the Service sets. The Service records completion and the next refresher date.

12. Audit cadence

The Service checks, on a stated cadence, that:

• the three-phase checklist was completed, in real time, for every case, with the whole team taking part
• anticoagulation, allergies and the anaesthetic plan were checked
• discharge criteria and written aftercare with an urgent route were met for every patient
• missed steps, overruled concerns and complications were reported and learned from

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

13. 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
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)
• CQC Fundamental Standards
• WHO Surgical Safety Checklist
• National Safety Standards for Invasive Procedures (NatSSIPs) and local safety standards for invasive procedures (LocSSIPs)
• Royal College of Ophthalmologists guidance
• Never-event learning (correct patient, correct eye, correct lens; retained items; wrong implant)
• Resuscitation Council UK and the Service's medical emergency and anaphylaxis arrangements
• The Service's correct patient, correct eye, correct lens policy

Related reading

• Related policy: Correct patient, correct eye, correct lens policy
• Related policy: Consent for ophthalmic procedures policy
• Related policy: Decontamination of ophthalmic instruments policy
• Related policy: Incident Reporting, Investigation and Learning Policy

14. 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.

15. 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.