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
- Ionising Radiation (Medical Exposure) Regulations 2017: https://www.legislation.gov.uk/uksi/2017/1322/contents
- IR(ME)R regulation 4, current Licensing Authority wording: https://www.legislation.gov.uk/uksi/2017/1322/regulation/4
- IR(ME)R regulation 6, employer's procedures, protocols and quality assurance programmes: https://www.legislation.gov.uk/uksi/2017/1322/regulation/6
- IR(ME)R regulation 8, accidental or unintended exposure: https://www.legislation.gov.uk/uksi/2017/1322/regulation/8
- IR(ME)R regulation 10, practitioner, operator and referrer duties: https://www.legislation.gov.uk/uksi/2017/1322/regulation/10
- GOV.UK guidance to IR(ME)R 2017: https://www.gov.uk/government/publications/ionising-radiation-medical-exposure-regulations-2017-guidance/guidance-to-the-ionising-radiation-medical-exposure-regulations-2017
- CQC IR(ME)R notification criteria: https://www.cqc.org.uk/guidance-providers/ionising-radiation/ionising-radiation-medical-exposure-regulations-irmer/criteria-making-notification
- Ionising Radiations Regulations 2017: https://www.legislation.gov.uk/uksi/2017/1075/contents
- HSE ionising radiation legal base: https://www.hse.gov.uk/radiation/ionising/legalbase.htm
- HSE Working with ionising radiation, Approved Code of Practice L121: https://www.hse.gov.uk/pubns/books/l121.htm
- Current IPEM equipment quality assurance reports and standards: https://www.ipem.ac.uk/
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:
- all patient examinations involving ionising radiation
- referral, justification, authorisation and exposure
- image acquisition, clinical evaluation and reporting where linked to the exposure
- X-ray, CT, mammography, fluoroscopy and interventional radiology equipment
- fixed, mobile and temporary imaging rooms
- employer's procedures and local rules
- diagnostic reference levels and local dose surveys
- staff who act as referrer, practitioner, operator, Radiation Protection Supervisor or Medical Physics Expert
- accidental or unintended exposure, including wrong patient, wrong examination and overexposure
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:
- patient identification
- referral entitlement
- practitioner entitlement
- operator entitlement
- justification and authorisation
- pregnancy and breastfeeding checks where relevant
- diagnostic reference levels
- equipment quality assurance
- repeat and reject analysis
- accidental or unintended exposure
- CQC notification assessment
- patient communication and duty of candour
- clinical audit
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:
- name and role
- professional registration where applicable
- modality entitlement
- examination entitlement
- supervision requirement
- training evidence
- date of sign-off
- expiry or review date
- restrictions, such as CT excluded or paediatric imaging excluded
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:
- patient identity
- referrer details
- clinical question
- relevant previous imaging where available
- expected benefit
- radiation risk
- pregnancy, breastfeeding or age-related risk where relevant
- alternative non-ionising modality considered where appropriate
- exposure protocol selected
- practitioner or authorising role
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:
- full name
- date of birth
- address or unique identifier
- examination requested
- body part or region
- laterality where relevant
- pregnancy or breastfeeding status where relevant
- consent to continue with the examination
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:
- correct patient
- correct examination
- correct body part and laterality
- correct equipment
- exposure factors or protocol
- shielding or positioning where current procedure requires it
- immobilisation or support need
- previous failed exposure or repeat risk
- equipment warning or fault
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:
- 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
- equipment faults
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:
- stop and make the patient safe
- secure the equipment and exposure record
- inform the Registered Manager and Radiation Protection Supervisor
- seek Medical Physics Expert advice where needed
- complete the preliminary investigation
- assess CQC notification against the current criteria
- inform the patient and referrer where the current source requires it
- complete duty of candour assessment where harm may have occurred
- record corrective action and learning
Staff do not decide notification thresholds from memory.
7. Training and entitlement review
Staff only act within their recorded entitlement.
Training records include:
- IR(ME)R training
- modality-specific training
- equipment-specific training
- radiation protection training
- patient identification training
- incident and notification training
- annual evidence of continued competence
- Medical Physics Expert or Radiation Protection Adviser input where required
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:
- Radiation Protection Supervisor for controlled or supervised areas where required
- Radiation Protection Adviser advice under IRR where required
- Medical Physics Expert advice under IR(ME)R where required
- controlled-area and supervised-area designation
- room signage and access control
- staff dose monitoring where required
- pregnancy-at-work risk assessment where applicable
- contingency arrangements for equipment failure
- local rules available at the point of use
The Service verifies the exact requirement against current IRR, HSE guidance and professional advice before adoption.
9. Responsibilities
- Registered Manager: owns this policy, ensures local rules exist, confirms named role holders and signs off annual review.
- Radiation Protection Supervisor: supports day-to-day compliance with local rules, controlled-area controls and staff escalation.
- Radiation Protection Adviser: advises on IRR compliance, staff and public protection and controlled-area arrangements.
- Medical Physics Expert: advises on patient dose, diagnostic reference levels, equipment quality assurance and exposure incident assessment.
- Practitioner: justifies exposures within entitlement.
- Operator: carries out practical aspects within entitlement and records exposure details.
- Referrer: supplies sufficient clinical information for the practitioner to decide whether there is sufficient net benefit.
- All staff: stop and escalate if patient identity, examination, equipment status or entitlement is uncertain.
10. Recording requirements
The Service keeps the following records:
- employer's procedures
- local rules
- entitlement matrix
- training records
- referral records
- justification and authorisation records
- exposure records
- dose records where available
- diagnostic reference level review
- local dose survey
- quality assurance checks
- equipment maintenance records
- repeat and reject analysis
- accidental or unintended exposure investigation
- CQC notification decision
- duty of candour decision
- improvement actions
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:
- Per exposure: Staff record patient identity, examination, authorisation and operator details.
- Monthly: the Radiation Protection Supervisor checks incidents, repeat exposure themes and equipment exceptions.
- Quarterly: the Registered Manager reviews IR(ME)R incidents, entitlement exceptions and employer's procedure compliance.
- Annually: the Service completes a radiation dose and diagnostic reference level review with Medical Physics Expert input.
- After any reportable or potentially reportable incident: the Service reviews local rules, training, equipment and corrective action.
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:
- policy owner
- version number
- date approved
- next review date
- changes made since the last version
- source material checked during the review
13. Related records
- Employer's procedures
- Local rules
- Radiation protection file
- Entitlement matrix
- Training matrix
- Equipment inventory
- Quality assurance log
- Dose review
- Incident register
- Duty of candour policy
- Improvement action register
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.
- Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R 2017) (https://www.legislation.gov.uk/uksi/2017/1322/contents)
- Ionising Radiations Regulations 2017 (IRR17) (https://www.legislation.gov.uk/uksi/2017/1075/contents)
- CQC Regulation 12: Safe care and treatment
- CQC IR(ME)R enforcement guidance and notification criteria
- Radiation Protection Adviser (RPA) and Medical Physics Expert (MPE) advice
- GOV.UK guidance to IR(ME)R 2017
- HSE ionising radiation guidance, including the Approved Code of Practice L121
- Current IPEM equipment quality assurance reports and standards
- CQC assessment framework and sector-specific guidance, as updated by CQC from time to time
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.