Sample policy · Ophthalmology

Surgical safety checklist policy for ophthalmic day surgery (ophthalmology)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The primary professional and patient-safety standards for surgical checklists are the WHO Surgical Safety Checklist and the National Safety Standards for Invasive Procedures (NatSSIPs), with Royal College of Ophthalmologists guidance for ophthalmic surgery. · primary source

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

5. Scope

This policy applies to:

6. The team and the genuine pause

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

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:

9. Recovery and discharge

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

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

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:

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 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.

Related reading

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

Version Date Author Changes
v1.1 2026-07-14 Verivius (sample) Added role ownership, checklist procedure, record fields, register links and related reading.
v1 2026-06-10 Verivius (sample) Conformed to the Verivius policy standard; original sections preserved and renumbered.

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.

An ophthalmic day list is high volume and near identical: the same procedure, the same drape, the same tray, case after case through a single morning. That sameness is the risk, because every patient arrives with two eyes and the intraocular lens power has been calculated from that one person's biometry and is not easily undone once it sits in the capsular bag. The person is usually awake under local anaesthetic and can hear whether the team genuinely stopped and confirmed the eye, the consent and the lens, or whether the list simply kept moving. A checklist spoken aloud catches the mismatch between list, mark, consent and lens box while that mismatch still costs nothing to put right. A checklist ticked afterwards records only that the case happened. The same record then travels home with the person, because written aftercare and a named urgent route out of hours are what stand between a red, painful eye on a Sunday evening and sight-threatening infection reaching a clinician in time.

  1. The three phases run in real time with the whole team present, read and answered aloud, not signed in advance or in retrospect. A genuine pause is what catches the wrong eye or a missing lens before it reaches the patient. A tick-box filled after the list catches nothing.

    Strong evidence: Sign-in, time-out and sign-out completion recorded, including who led each pause, and the audit-cadence check that the three-phase checklist was completed in real time for every case with the whole team taking part.

    Weak evidence: A file of checklists in which every box is ticked, in one pen, in one hand, and no case in a whole year records an exception, a pause that ran long, or a step that could not be completed. Nobody is named as having led sign in, time out or sign out. Asked how it actually runs, staff describe the surgeon calling the checks out while the scrub practitioner is still setting the tray and the recovery nurse is in another room, and sign out being signed while the next patient is already being walked in.

    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. The operative eye is marked and confirmed, and the intraocular lens (power, model and serial or lot number) is recorded and confirmed against the record, not assumed from the list, so the person receives the lens planned for their eye and can be identified if that model is later recalled.

    Strong evidence: Patient identifiers, procedure, eye, consent, mark and implant-or-lens confirmation in the surgical-safety record, with the sign-out lens power, model and serial or lot number captured.

    Weak evidence: The operative eye recorded as "as per list" or "correct" rather than as the eye that was marked, seen and confirmed aloud against the consent form and the biometry. The lens entry reads "intraocular lens inserted" with no power, model or serial or lot number, so if that model is later recalled the service cannot say which people are carrying it, and nobody is named as having confirmed the lens against the biometry before it was opened.

    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.

  3. Instrument, swab and sharps counts reconcile before the patient leaves the operating area, and a failed count triggers escalation rather than being waved through.

    Strong evidence: The count checks in the record and the failed-count or retained-item concern opened on the incident register.

    Weak evidence: A counts field pre-printed "correct" on the template, or left blank because a short case under local anaesthetic is treated as too minor to count, with sign out signed before the count was actually reported back. The incident register holds no failed count and no retained-item concern at all, even though staff can readily describe one that was sorted out on the day and never written down.

    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. Stop-the-line authority is real: a raised concern is acted on before the case continues, and an overruled concern is recorded with how it was resolved, so the colleague who meets the same call next time can see what was decided and why.

    Strong evidence: Stop-the-line concerns and how they were resolved in the record, and the audit check that overruled concerns and missed steps were reported and learned from.

    Weak evidence: Stop the line appears in the policy and on the induction slides, but no concern is recorded in any case across months of lists, which says the authority is not being used rather than that nothing has gone wrong. Where a concern was raised there is a tick and no note of what actually changed before the case continued, and an overruled concern has no record of who decided, on what basis, and what happened to the patient next.

    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.

  5. The patient goes home with safe discharge in place: written aftercare naming the symptoms that need urgent help and exactly how to reach urgent help out of hours, plus a recorded follow-up, not a generic leaflet.

    Strong evidence: Recovery and discharge instructions, follow-up and safety-netting in the record, and the audit check that discharge criteria and written aftercare with an urgent route were met for every patient.

    Weak evidence: Discharge evidenced by a signature against a single generic leaflet issued identically to a cataract patient and an oculoplastic patient, with "advice given" ticked. The drops the person is to use and for how long are not written down, the symptoms that need urgent attention are not named for them to take home, the urgent contact is the daytime clinic number with nothing for evenings, weekends or bank holidays, and follow-up sits as "to be arranged" with no date and no owner.

    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 missed step or complication runs to a recorded outcome the same day. Where NHS-funded care or NHS contract requirements apply, a wrong-eye, wrong-implant or retained-item event is handled within the Never Events framework rather than downgraded.

    Strong evidence: The incident and duty-of-candour record for the event, with the Regulation 20 duty of candour opened to the person where the notifiable safety incident threshold for this provider type is met, and the audit check that complications were reported and learned from. That duty is owed to the person and is not discharged by Never Events reporting under NHS contract requirements.

    Weak evidence: The complication is logged well after the list, or logged and then left open with no recorded outcome and no completed actions, so the entry proves the event happened and nothing more. A wrong-lens or retained-item event is written up as "no harm, corrected on the day" and closed, with nothing to show that anyone considered whether the notifiable safety incident threshold under Regulation 20 for this provider's type was met, and, separately, for NHS-funded care, whether the Never Events framework applied. The incident entry, the audit summary and the governance minutes then describe the same event in three different ways.

    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.

Related

Last verified 20 July 2026

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Last reviewed 10 June 2026