Sample policy · Diagnostic imaging

Contrast media safety and reaction management policy (diagnostic imaging)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The leading professional sources for contrast media safety are RCR contrast guidance, Resuscitation Council UK guidance on the emergency treatment of anaphylaxis, and MHRA drug and device safety material. · 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))

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))

The full text 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

This policy sets out how the Service screens patients before contrast administration, obtains and records consent, administers contrast safely and responds to contrast-media adverse reactions.

It covers iodinated contrast, gadolinium-based contrast and ultrasound contrast where used by the Service.

Modality applicability: this policy applies to CT, MRI, interventional radiology and ultrasound where contrast media are administered. Imaging centres that do not administer contrast record this policy as not applicable unless they add contrast-enhanced examinations.

4. Sources to verify before adoption

5. Scope

This policy applies to:

The policy applies to employed staff, contractors and visiting clinicians who administer contrast under the Service's governance.

6. Contrast safety process

The Service does not administer contrast until a competent role holder has completed and recorded the contrast safety checks.

6.1 Request and protocol review

The Radiologist or authorised practitioner reviews the request and confirms whether contrast is clinically justified.

The review considers:

Where the contrast risk is uncertain, Staff escalate to the Radiologist before administration.

6.2 Patient screening

Staff complete screening before contrast is prepared.

The screening record includes:

The Service uses current source material and local clinical governance to decide which patients require renal-function testing. Staff do not apply informal deadlines or thresholds from memory.

6.3 Consent and information

Staff give the patient information about why contrast is proposed and what to report during or after administration.

The conversation covers:

Consent is recorded in the patient record or examination record.

6.4 Preparation and IV access

Staff prepare contrast according to local protocol and manufacturer information.

The preparation record includes:

The Service checks emergency equipment and medicines before contrast sessions begin.

6.5 Post-administration observation

Staff observe the patient according to local protocol and current source material.

Observation includes:

The Service records early departure against advice and any safety-netting advice given.

7. Reaction management

The Service classifies contrast reactions according to local clinical protocol and current professional guidance.

7.1 Mild reaction

For mild symptoms, Staff:

7.2 Moderate or severe reaction

For moderate, severe or rapidly progressing symptoms, Staff:

The Service aligns the emergency algorithm with current Resuscitation Council UK guidance and local prescriber arrangements.

7.3 Extravasation

If contrast extravasation is suspected, Staff:

7.4 Reporting and learning

The Service assesses whether the reaction or device issue should be reported through the MHRA Yellow Card scheme.

The review checks:

8. Repeat contrast and high-risk patients

The Radiologist reviews repeat contrast in the same patient where local policy or patient risk requires senior review.

High-risk cases may include:

The decision record states the rationale, precautions and patient advice.

9. Responsibilities

10. Recording requirements

The Service keeps the following records:

Records are kept in the Service governance records and linked to the patient record where relevant.

11. Audit cadence

The Service uses the following Verivius default audit rhythm unless current RCR, Resuscitation Council UK, MHRA, CQC or local source material requires a different rhythm:

Audit findings are recorded as improvement actions with an owner and review date.

12. Version control and review date

The Service keeps a controlled copy of this policy. The footer or document-control table records:

13. Related records

Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.

14. 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.

15. 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.

16. Document control

Version Date Author Changes
v1 2026-06-10 Verivius (sample) Conformed to the Verivius policy standard: added statutory anchor, verbatim Regulation 12 quotes, 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.

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.

Contrast media are given to people who are usually well, to sharpen a picture rather than to treat anything, and that changes what safe means here: the person accepts a small but real risk of anaphylaxis, extravasation or renal harm in exchange for a diagnostic benefit they largely have to take on trust. The pressure point is the list, because screening questions about previous reactions, renal function, metformin and pregnancy are the easiest thing to compress when the scanner is running late, and a power injector will deliver the dose whether or not anyone asked. Someone lying alone in the bore, part way through a timed acquisition, cannot easily tell you their throat feels tight, so the observation period and the advice about delayed symptoms are often the only thing standing between a mild flush and a collapse in the car park. Batch and operator detail matter for the same human reason: when a product or injector problem surfaces weeks later, the imaging record is the only way to work out who else received it and to reach them.

  1. Screening is completed and recorded before contrast is prepared, not after the patient is on the table. Missing prior-reaction, allergy, renal or metformin and pregnancy checks, and renal-function thresholds applied from memory, are how a patient with a known risk ends up receiving contrast anyway.

    Strong evidence: The screening record (patient identity, previous contrast reaction, asthma or significant allergy history, renal disease or dialysis, current renal-function where required, diabetes and metformin status, pregnancy or breastfeeding, relevant medication, consent) completed before contrast is prepared, with renal-function testing decided from current source material and local governance rather than informal thresholds (section 6.2).

    Weak evidence: Screening forms completed or countersigned after the cannula is already in, or scanned in as one undated sheet with the day's list so nothing shows what was known before the contrast was drawn up. Prior-reaction, metformin and pregnancy boxes ticked identically down a whole list, and two radiographers giving two different renal-function thresholds when asked where the number comes from.

    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. Emergency medicines and equipment are checked before contrast sessions and the reaction response matches current Resuscitation Council UK anaphylaxis guidance, not a local improvisation. Readiness counts at the moment contrast is given: an out-of-date adrenaline ampoule or an undated wall algorithm is otherwise discovered while someone is already reacting.

    Strong evidence: The pre-session emergency equipment and medicines check (section 6.4) and the moderate or severe reaction response following the local emergency algorithm aligned to current Resuscitation Council UK guidance (section 7.2).

    Weak evidence: An emergency medicines and equipment check sheet signed off in a block at the end of the week, including days the room was closed, or a sheet that stops at the tray and never checks the adrenaline expiry inside it. A local anaphylaxis algorithm laminated on the wall with no version date, and nobody able to say when it was last compared with current Resuscitation Council UK guidance.

    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. Every administration is traceable to agent, dose, batch and operator, so a product or device problem can be found afterwards. Missing batch numbers, operator or time-administered entries break the trail between a faulty batch and the people who received it.

    Strong evidence: The preparation and administration record (contrast agent name, batch number where required, dose or volume, expiry check, route, cannula site and gauge, injector or manual, operator, time administered) in section 6.4, held in the service governance records and linked to the patient record (section 10).

    Weak evidence: Batch number blank whenever the power injector was used but filled in for hand injections, so the gap tracks the workflow rather than the service's own protocol. Operator recorded as "radiographer" or a bare set of initials rather than a named person, and time administered copied from the scan start time. The test is simple: ask which patients received a named batch, and if the only answer is the delivery note or the stock room, the trail stops short of the patient.

    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.

  4. After a reaction the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card decision and the duty of candour decision are each made and recorded, and the batch preserved, not left open. They are separate duties: a Yellow Card report goes to the MHRA about the product, while the Regulation 20 duty of candour is owed to the person themselves and is not a notification, and neither one discharges the other.

    Strong evidence: The reporting and learning review (reaction severity, agent involved, device or injector issue, batch or product concern, patient harm, duty of candour requirement, protocol update), the MHRA Yellow Card decision record and the separate duty of candour decision record (sections 7.4 and 10), with contrast and batch information preserved for moderate or severe reactions (section 7.2).

    Weak evidence: Reaction records that end at "patient recovered, no further action" with no line stating whether a Yellow Card report was considered or whether the duty of candour threshold was met, so the decision has to be inferred from the absence of a report. Yellow Card submission is voluntary for the service, which is exactly why the recorded decision is the only proof the question was weighed at all. Vial, syringe and injector tubing discarded before the batch was noted, so a product or device concern cannot be traced even where the reaction was severe.

    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.

  5. Post-administration observation happens and early departure against advice is recorded, not assumed uneventful. A patient who leaves without safety-netting advice has no way of knowing which delayed symptom means come back.

    Strong evidence: The observation record (immediate symptoms, rash, itch or swelling, breathing difficulty, nausea, dizziness or collapse, extravasation or injection-site pain, delayed-symptom advice) and the recording of early departure against advice and safety-netting advice given (section 6.5).

    Weak evidence: An observation entry pre-printed as "no adverse reaction" and signed before the observation period had finished, so every patient looks the same on paper. Patients who removed their own cannula and left early are indistinguishable from those who stayed, and nothing records what the person was told about delayed symptoms or who to contact once they had gone home.

    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. High-risk and repeat contrast decisions carry a recorded senior rationale, and any moderate or severe reaction triggers a focused review. A repeat exposure waved through on initials alone leaves the next clinician nothing showing what risk was weighed or what the patient was told.

    Strong evidence: The Radiologist's decision record stating rationale, precautions and patient advice for high-risk or repeat cases (section 8), and the after-any-moderate-or-severe-reaction review of screening, emergency response, product reporting and learning (section 11).

    Weak evidence: Repeat contrast inside the same clinical episode waved through verbally, with the record carrying only a radiologist's initials against the protocol and no rationale, precautions or patient advice. After a moderate or severe reaction the incident form is closed as "patient recovered" without anyone revisiting whether screening picked up the risk, whether the emergency response worked and whether the contrast protocol needs changing.

    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.

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Last verified 20 July 2026

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Last reviewed 10 June 2026