Sample policy · Ophthalmology

Intravitreal injection safety policy (ophthalmology)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The clinical primary for this procedure is the Royal College of Ophthalmologists intravitreal injection guidance, read with each drug's Summary of Product Characteristics. · 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))

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f) (sufficient equipment + medicines supply))

the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))

assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated, (Reg 12(2)(h) (infection control))

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

Intravitreal injections, most often anti-VEGF drugs for age-related macular degeneration and diabetic macular oedema, are among the highest-volume procedures an independent eye clinic performs. The most serious complication is endophthalmitis, a sight-threatening infection inside the eye. This policy sets out how the Service gives intravitreal injections safely: the right drug in the right eye, a clean aseptic technique that lowers the risk of infection, and clear advice and follow-up so that infection is caught and treated early.

The Service must verify this policy against current Royal College of Ophthalmologists guidance on intravitreal injection and the drug manufacturers' instructions before adoption.

4. Sources to verify before adoption

5. Scope

This policy applies to:

6. The right drug, dose and eye

Before any injection the team confirms, against the clinical record and the treatment plan:

The eye, the drug and the dose are confirmed aloud immediately before injection.

7. Aseptic technique and infection prevention

The Service follows an aseptic, no-touch technique designed to lower the risk of endophthalmitis:

The Service confirms its exact technique against current Royal College of Ophthalmologists guidance.

8. After the injection

9. Suspected endophthalmitis

A patient reporting pain or falling vision after an injection is treated as possible endophthalmitis until proven otherwise. The Service:

10. Recording and reporting

Operational controls to adapt

Roles and responsibilities

Intravitreal injection procedure

  1. Confirm indication and treatment plan. Check the diagnosis, eye, drug, dose, interval, consent and whether the patient is fit for injection that day.
  2. Check drug and eye. Match patient, eye, drug, dose, batch, expiry and prescription or protocol before preparation and again before injection.
  3. Prepare aseptically. Follow the approved room, hand hygiene, antisepsis, draping, eyelid and no-touch technique.
  4. Inject and monitor. Record the injection, immediate tolerance, any complication and whether intraocular pressure or other checks are required.
  5. Give safety-netting. Explain symptoms requiring same-day urgent contact, including increasing pain, reduced vision, redness or discharge.
  6. Provide urgent response. Treat suspected endophthalmitis, retinal detachment, severe inflammation or sudden vision loss as urgent and direct the patient to the agreed emergency route.
  7. Record and review. Link drug batch, consent, eye, aftercare, complication and follow-up records. Open incidents for wrong-drug, wrong-eye, infection concern, delayed response or missing traceability.

Records and register links

The intravitreal-injection record should include:

Wrong-eye, wrong-drug, suspected infection and urgent-response failures are opened on the incident register. Medicine-storage risks, repeat process gaps and recall actions are tracked through the risk register and improvement-actions register.

11. Training and competency

A clinician gives intravitreal injections only after training and a check that they can do it safely, and the Service repeats the competency check on a stated cadence. Staff who prepare drugs or assist are trained in the aseptic technique and the safety-netting advice. The Service records who is competent and the next refresher date.

12. Audit cadence

The Service checks, on a stated cadence, that:

The Registered Manager and the clinical lead 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, injection procedure, record fields, register links and related reading.
v1 2026-06-10 Verivius (sample) Conformed to the Verivius policy standard: added statutory anchor, verbatim Regulation 12 text, plain-English summary, standard sources and document-control blocks. Original operational 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.

Awaiting final verification

The endophthalmitis and post-injection sight-loss escalation, the duty-of-candour and notification framing, and whether the asepsis wording is clinically sufficient must be confirmed by an ophthalmology specialist for your service.

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 intravitreal injection breaches a sterile space in a procedure that lasts a couple of minutes and is repeated dozens of times in a clinic day, which is exactly what makes endophthalmitis so dangerous here: a single lapse in antisepsis or technique can seed a sight-threatening infection that does not declare itself until the patient is home and days have passed. The person cannot see what technique was used and will not know anything is wrong until pain or falling vision begins, so the whole protection rests on things they never witness, namely the antisepsis applied every time, the right drug traced to a batch, the advice that tells them which symptoms mean go back today, and a route that can examine the eye the same night. The evidence trail matters because when one of those injections goes wrong, the batch record, the injection log and the safety-netting note are what let the service find every other eye put at risk and get the person to sight-saving treatment before the window closes, and a card audited only when someone is looking is a card that finds the cluster too late.

  1. Every injection is given by the aseptic, no-touch technique that keeps a sight-threatening infection out of the eye, with the ocular-surface antisepsis the current Royal College of Ophthalmologists guidance sets applied to each case, not a technique named in the policy and left to habit at the chair. Preventing endophthalmitis is the point of the whole procedure, and the antisepsis is the single step that matters most.

    Strong evidence: The per-injection record showing the antiseptic used and that the aseptic preparation was carried out, the injection-safety audit sampling that antisepsis and the no-touch technique were applied and recorded for every injection, and the endophthalmitis rate tracked over time so a cluster pointing to one room, one batch or one operator is seen.

    Weak evidence: A policy that describes povidone-iodine antisepsis and a clean room kept for the purpose but injection records with no field to show either was actually done, so the most important safety step leaves no trace. An infection audit that is a downloaded checklist scored highly once, with no re-audit and no actions, and no endophthalmitis rate kept at all, so a run of infections would only surface once a patient has lost sight. The antiseptic strength and the contact time live in the policy and its named source, not here.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(2)(h)

  2. The right drug, at the right dose and strength, goes into the right eye, confirmed against the clinical record and the prescription or protocol and said aloud immediately before the needle goes in, not assumed from the clinic list or carried over from the previous visit. Wrong-eye and wrong-drug are the never-events this procedure exists to prevent.

    Strong evidence: The injection record showing the eye, drug, dose and strength checked against the treatment plan and prescription at preparation and again at the chair, linked to the service's correct patient, correct eye, correct lens check, with that final confirmation recorded for the specific injection.

    Weak evidence: An injection recorded against a clinic list with no evidence the eye and drug were reconfirmed at the moment of injection, or a record that names the drug but never states which eye received it. Consent, treatment plan and injection sitting in three places that were never brought together at the chair, so nothing shows the person injecting checked they had the right eye and the right drug in front of them.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(2)(a)-(b), read with reg 12(2)(g)

  3. The drug that enters the eye can be traced back to a specific batch, an intact storage and cold-chain history and an in-date stock, so a recall or a suspected bad batch can be followed to every eye it reached. The batch or lot number is recorded for the injection at the time, not reconstructed from a delivery note afterwards.

    Strong evidence: The injection record carrying the drug, batch or lot number and expiry for each case, the medicines storage and cold-chain log with escalation recorded for any excursion, and the recall and stock-check trail linking a batch to the injections it was used for, with suspected drug or device reactions raised through the MHRA Yellow Card scheme.

    Weak evidence: Injections logged with the drug name but no batch or lot number, so a recall notice cannot be turned into a list of patients to contact. A medicines fridge with a run of suspiciously identical daily readings and nothing recorded about what was done when one fell out of range, and an 'all in date' claim with no dated stock and expiry check behind it. The storage temperature range belongs in the product's storage instructions, not here.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(2)(g)

  4. The person leaves knowing the red-flag symptoms of infection in the injected eye, in a form they can keep, and holding a same-day route to urgent help that can actually examine an injected eye out of hours, not a leaflet and a daytime phone number that cannot assess the eye. Endophthalmitis usually declares itself days later, so the patient recognising it early is part of the safety of the procedure.

    Strong evidence: The record that written safety-netting advice covering increasing pain, increasing redness, falling vision, new floaters or light sensitivity was given, and that the specific urgent route given was one that can assess an injected eye the same day, including out of hours, tested against a real escalation rather than assumed to work.

    Weak evidence: Safety-netting recorded as 'advice given' with no note of which symptoms or which route, or a route that reaches a general helpline unable to examine an eye until the next clinic. An out-of-hours number no one has ever tested, so it is first used the night a patient's vision is failing.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  5. A patient reporting pain or falling vision after an injection is treated as possible endophthalmitis until proven otherwise, gets same-day assessment by an ophthalmologist who can examine the eye and a tested route to a vitreoretinal service for the urgent treatment sight loss needs, and, where the harm threshold is met, is told in person what happened as soon as reasonably practicable. The duty of candour to the person is opened or ruled out with reasons, and it is not treated as discharged by logging the incident or by making a notification.

    Strong evidence: The incident record showing same-day assessment and referral along a pre-tested vitreoretinal pathway, the duty-of-candour record showing the person was given an apology and a truthful account in person as soon as reasonably practicable with written follow-up, and separate lines for the CQC statutory notification and the MHRA Yellow Card report where each is due, none standing in for another.

    Weak evidence: A suspected endophthalmitis managed as a routine review the following week rather than the same day, or a referral pathway to vitreoretinal care that exists on paper but has never been walked. An incident logged with the duty-of-candour decision left blank, so the person it happened to has no record of being told anything, and a service treating the CQC notification or the Yellow Card as if it satisfied the separate duty owed to the patient.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 20

  6. Only a clinician assessed as competent gives the injection, and the staff who prepare the drug and assist are trained in the aseptic technique and the safety-netting advice, with competence re-checked on a stated cadence rather than assumed once granted. Competence to do this safely is proven and kept current, not inferred from a job title.

    Strong evidence: The competency file for each injecting clinician showing the initial practical sign-off against the technique and the dated re-checks, and the training records for the staff who prepare drugs, assist and give safety-netting advice, with the next refresher date tracked.

    Weak evidence: A clinician injecting on the strength of a course certificate from years ago with no evidence of a practical competency check or any re-assessment since. Support staff giving aftercare advice with no record they were trained in it, and a competency cadence stated in the policy that no one is actually held to. The re-check interval is a matter for the service and our default, not a figure fixed in law.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(2)(c)

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Last verified 20 July 2026

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Last reviewed 10 June 2026