Sample policy · Diagnostic imaging

IR(ME)R local rules and radiation safety policy (diagnostic imaging)

Statutory anchor: Ionising Radiation (Medical Exposure) Regulations 2017 (SI 2017/1322) and the Ionising Radiations Regulations 2017 (SI 2017/1075). This policy also engages Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). · primary source

1. What the regulation says

The primary law for this policy is the Ionising Radiation (Medical Exposure) Regulations 2017 and the Ionising Radiations Regulations 2017. These are not Health and Social Care Act regulations, so they are not in the Verivius regulation manifest. The CQC regulation engaged by this policy is Regulation 12 (safe care and treatment), quoted verbatim below.

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 Regulation 12 is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12, and the full text of the Ionising Radiation (Medical Exposure) Regulations 2017 is at https://www.legislation.gov.uk/uksi/2017/1322/contents. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. Regulation 12 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. For services that expose patients to ionising radiation, the detailed duties are set by the Ionising Radiation (Medical Exposure) Regulations 2017 and the Ionising Radiations Regulations 2017, which this policy operationalises alongside Regulation 12.

3. Purpose

This policy sets out how the Service manages local rules, entitlement, justification, authorisation, patient identification, equipment quality assurance and response to accidental or unintended medical exposures.

It covers IR(ME)R governance for patient exposures and IRR governance for staff and public radiation protection.

Modality applicability: this policy applies to X-ray, CT, mammography, fluoroscopy, interventional radiology and any other examination using ionising radiation. Ultrasound-only and MRI-only services record this policy as not applicable unless they add an ionising-radiation modality.

4. Sources to verify before adoption

Current IR(ME)R regulation 4 is the Licensing Authority provision. It says the Licensing Authority may "issue a licence" where the regulation applies. The Service must not treat regulation 4 as the role-definition source. This policy uses current IR(ME)R regulations 2, 6 and 10 for employer, practitioner, operator and referrer controls.

5. Scope

This policy applies to:

This policy applies to private, self-pay, insured and NHS-contracted work where the Service carries out the exposure.

6. IR(ME)R local rules and radiation safety process

The Service does not expose a patient to ionising radiation unless the exposure is referred, justified, authorised and carried out by staff entitled under the employer's procedures.

6.1 Employer's procedures and local rules

The Registered Manager keeps a controlled set of employer's procedures for each ionising-radiation modality.

The procedures cover:

The Service checks each procedure against the current IR(ME)R source, the current CQC notification criteria and Medical Physics Expert advice before adoption.

6.2 Entitled role holders

The Service keeps an entitlement matrix. The matrix states who may act as referrer, practitioner and operator for each modality and examination type.

The matrix records:

IR(ME)R regulation 10 states that "The practitioner is responsible for the justification of an exposure." The Service checks the full current regulation before approving local entitlement.

6.3 Referral and justification

The practitioner justifies each exposure before it is made unless the employer's procedures allow an authorised protocol for the specific examination.

The justification record includes:

Staff do not use this template as the justification source. The local employer's procedure and current IR(ME)R guidance define the exact process.

6.4 Patient identification

Staff complete patient identification before exposure.

The check includes:

Where the patient cannot confirm identity, Staff use the Service's documented alternative identification process and record who confirmed identity.

6.5 Operator exposure controls

The operator checks the examination protocol before exposure.

The check covers:

The operator stops the exposure process if any check is uncertain. The operator escalates to the practitioner, Radiation Protection Supervisor or Medical Physics Expert according to the local procedure.

6.6 Equipment quality assurance and dose review

The Service keeps a quality assurance schedule for each item of ionising-radiation equipment.

The schedule covers:

The Service uses the current IPEM reports, Medical Physics Expert advice and manufacturer instructions to set check types and frequency. This template does not restate technical testing intervals.

6.7 Accidental or unintended exposure

The Service records and analyses any suspected accidental or unintended exposure.

IR(ME)R regulation 8 requires the employer to "undertake an immediate preliminary investigation" where the relevant test is met. It also says notification is required unless the investigation shows "beyond a reasonable doubt" that no such exposure has occurred. The Service checks the full current regulation and CQC criteria before deciding the route.

The response process includes:

Staff do not decide notification thresholds from memory.

7. Training and entitlement review

Staff only act within their recorded entitlement.

Training records include:

The Registered Manager reviews entitlement after an incident, equipment change, modality change, role change or source-material update.

8. Radiation protection arrangements

The Service appoints or has access to the radiation protection roles required for its equipment and work.

The arrangements include:

The Service verifies the exact requirement against current IRR, HSE guidance and professional advice before adoption.

9. Responsibilities

10. Recording requirements

The Service keeps the following records:

Records are kept in the Service governance records and the clinical record where applicable.

11. Audit cadence

The Service uses the following Verivius default audit rhythm unless current IR(ME)R, IRR, CQC, HSE, IPEM or Medical Physics Expert 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. All prior 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.

Ionising radiation is the rare clinical risk you cannot see, cannot feel and cannot take back once the exposure is made. A wrong patient, a wrong examination or an overexposure is delivered in the instant the button is pressed, and any harm may not surface for years. That is why this policy leans so hard on the record made before the exposure: the justification, the entitlement of the person carrying it out and the confirmed identity of the person in front of the machine, together with the immediate preliminary investigation when something goes wrong. The evidence trail is not administration for its own sake. It is the only way a service can show an exposure was warranted, find and follow up everyone caught by an equipment fault or a systematically wrong protocol, and keep the notification it owes CQC separate from the duty of candour it owes the person. The technical values, the dose factors, the diagnostic reference levels and the testing intervals, stay in the live IR(ME)R source, current IPEM reports and Medical Physics Expert advice rather than being restated here, because those are the figures that change and must never be worked from memory.

  1. No patient is exposed to ionising radiation until the exposure has been referred with enough clinical information, justified by the practitioner and authorised, so a request is weighed for net benefit rather than a view being taken simply because it was asked for. The practitioner is recorded as responsible for the justification, and where an authorised protocol is used it is one written for that examination, not a blanket protocol stretched to cover it.

    Strong evidence: The justification and authorisation record for the exposure (patient identity, referrer details, clinical question, relevant previous imaging where available, expected benefit, radiation risk, pregnancy or age-related risk where relevant, alternative non-ionising modality considered where appropriate, exposure protocol selected and the authorising practitioner), tied to a valid authorised protocol where the employer's procedures allow one for that specific examination.

    Weak evidence: Justification signed off or written up after the exposure was already made, a single authorised protocol applied to examinations it was never written for, referrals accepted with too little clinical information for anyone to judge net benefit, or the authorising role recorded as a bare set of initials with no named practitioner behind the justification.

    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.

    Ionising Radiation (Medical Exposure) Regulations 2017, reg 10 and reg 11

  2. The service runs from a controlled, current set of written employer's procedures for each modality, checked against the live IR(ME)R source, the current CQC notification criteria and Medical Physics Expert advice before adoption, and every referrer, practitioner and operator works inside a recorded entitlement rather than custom and practice. Who may carry out which examination is written down and dated, not assumed from someone's job title.

    Strong evidence: The controlled employer's procedures held per modality and the entitlement matrix (name and role, professional registration where applicable, modality and examination entitlement, supervision requirement, training evidence, date of sign-off, review or expiry date and any restriction such as CT or paediatric imaging excluded), with the procedures showing the current-source, CQC-criteria and Medical Physics Expert check made before adoption.

    Weak evidence: An uncontrolled or undated set of procedures, or a generic template adopted word for word with no evidence it was checked against the live regulation or Medical Physics Expert advice. An entitlement matrix with blank sign-off dates, expired reviews left live, or a member of staff carrying out an examination the matrix does not list them as entitled to do.

    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.

    Ionising Radiation (Medical Exposure) Regulations 2017, reg 6

  3. The right person receives the right examination on the right side. Identity, the examination requested, the body part and laterality, and pregnancy or breastfeeding status where relevant are confirmed with the person and recorded before the exposure is made, not reconstructed from the day's list afterwards. A wrong-patient, wrong-examination or wrong-side exposure cannot be taken back once the button is pressed, so the check that prevents it has to sit before it.

    Strong evidence: The patient identification record completed before exposure (full name, date of birth, address or unique identifier, examination requested, body part or region, laterality where relevant, pregnancy or breastfeeding status where relevant and consent to continue), and, where the patient cannot confirm their own identity, the documented alternative-identification process naming who confirmed it.

    Weak evidence: Identity confirmed after the patient is positioned or the exposure already taken, pregnancy and laterality boxes completed identically down a whole day's list, laterality taken from the referral rather than confirmed with the person, or the alternative-identification route used with no record of who vouched for the patient.

    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.

  4. A suspected accidental or unintended exposure, including a wrong patient, a wrong examination or an overexposure, triggers an immediate preliminary investigation, and the notification to CQC is assessed against the current IR(ME)R criteria rather than decided from memory. The duty of candour is a separate, recorded decision: telling the patient and referrer and notifying CQC do not discharge the candour owed to the person, and none of these stands in for another.

    Strong evidence: The accidental or unintended exposure record showing the equipment and exposure record secured, the immediate preliminary investigation completed, Medical Physics Expert advice sought where needed, the CQC notification decision assessed against the current criteria, and a separate duty of candour decision recorded where harm may have occurred, with corrective action and learning captured.

    Weak evidence: A notification threshold decided from memory rather than against the current criteria, an incident closed as the patient came to no harm with no recorded notification decision and no separate candour decision, or the equipment and exposure record not secured so the exposure can no longer be reconstructed. Weakest of all is a preliminary investigation that never happened because the event was quietly logged and moved on from.

    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.

    Ionising Radiation (Medical Exposure) Regulations 2017, reg 8

  5. Each item of ionising-radiation equipment runs to a quality assurance schedule whose check types and frequency are set from current IPEM reports, Medical Physics Expert advice and the manufacturer's instructions, with the records retained, faults carried into corrective action, and equipment returned to use only after a documented post-service check. What matters is that the equipment is demonstrably safe to use on the next patient, not that a schedule exists on paper.

    Strong evidence: The quality assurance schedule and its records for each item (acceptance testing, routine performance testing, servicing and maintenance, post-service return-to-use checks, image-quality checks, dose monitoring, diagnostic reference level review, local dose surveys where practicable, reject and repeat analysis and equipment faults), with the check types and frequency traceable to IPEM, Medical Physics Expert advice or the manufacturer rather than set locally.

    Weak evidence: A quality assurance sheet with no Medical Physics Expert input behind its intervals, equipment put back into use after a repair with no recorded return-to-use check, faults logged but never carried into a corrective action, or a diagnostic reference level review that has not been done because nobody owns it. Check types or frequencies quoted from memory rather than from a named current source.

    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. Staff, carers and members of the public are protected alongside the patient, not treated as an afterthought once the exposure is justified. Local rules are available at the point of use and a Radiation Protection Supervisor is appointed for every controlled or supervised area that needs one, with the wider radiation protection arrangements, including the risk assessment covering pregnant or breastfeeding workers, live at the point of exposure rather than sitting in a radiation protection file nobody opens.

    Strong evidence: The radiation protection arrangements evidenced in use (local rules at the point of use, the appointed Radiation Protection Supervisor for controlled or supervised areas, Radiation Protection Adviser advice under IRR where required, controlled-area and supervised-area designation and signage, staff dose monitoring where required, the pregnancy-at-work risk assessment where applicable and contingency arrangements for equipment failure).

    Weak evidence: Local rules held centrally but not available in the room where the exposure happens, no named Radiation Protection Supervisor for a controlled area that plainly needs one, dose-monitoring badges issued but never read or acted on, or a pregnant worker with no recorded risk assessment. Signage and access control described in the policy but not matching what is actually on the door.

    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.

    Ionising Radiations Regulations 2017, reg 18

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Last verified 20 July 2026

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Last reviewed 10 June 2026