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.

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Last reviewed 10 June 2026