The Approved Code of Practice (ACoP) is available here. It provides detailed advice about the scope and duties of the requirements imposed by IRR17. It is aimed at employers with duties under the Regulations but should also be useful to others, such as radiation protection advisers, health and safety officers, radiation protection supervisors and safety representatives.
Radiation employers will need to appoint an RPS to comply with the Ionising Radiation Regulations 2017 (IRR 17) to ensure adherence, among other areas, to the arrangements set out in the Local Rules. An RPS needs to understand the requirements of the Regulations; command sufficient authority from the people doing radiation work in order to supervise the radiation protection aspects of that work and to know what to do in an emergency.
The Health and Safety Executive (HSE) have also produced a very useful publication detailing the role of the RPS which is freely available here
Radiation employers will need to consult a suitable RPA for advice on complying with the Ionising Radiations Regulations 2017 (IRR17). IRR17 specifies particular matters on which radiation employers should seek advice from a suitable RPA. The Approved Code of Practice in support of IRR17 gives further guidance on this topic. Radiation employers need to check that the RPA selected meets the criteria of competence in the HSE Statement on Radiation Protection Advisers and has the relevant experience to make them suitable to provide the advice needed.
If an individual wishes to act as a RPA they must either:
ii) Report 91 - Recommended Standards for the Routine Performance Testing of Diagnostic X-Ray Imaging Systems (2005).
This report replaces IPEM Report 77 and provides essential guidance for anyone responsible for diagnostic x-ray equipment. This document gives clear advice on which routine performance tests are essential and which are desirable, where to get information on how to do them, who should be doing them and how often they should be done. For many tests it also gives guidance as to when the results indicate further action should be taken. This second edition takes into account the introduction of new technologies in medical imaging including CR, DDR and image display devices and is available to buy via the IPEM website
The Ionising Radiation (Medical Exposure) Regulations IR(ME)R 2017 come into effect on 6th February 2018 and replace The Ionising Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000).
The Regulations are available from The Stationery Office here.
IR(ME) Regulations are flexible and allow a wide variety of practices to be undertaken as long as there is clear justification. Responsibility for compliance with IR(ME)R rests with the employer and all entitled duty holders as defined in the Regulations. A very important document for radiographers with IR(ME)R duties is the 2008 jointly authored publication entitled "A Guide to Understanding the Implications of the Ionising Radiation (Medical Exposure) Regulations in Radiotherapy written by SCoR, IPEM, RCR and HPA. This will be updated during 2018 to reflect the new legislation.
IR(ME)R is legislation aimed at the protection of the patient against the hazards associated with ionising radiation. It is made as criminal law rather than civil law. The main difference being that if there is a breach of civil law then the law seeks to establish fault and award compensation; in criminal law an illegal act is punished, compensation is a secondary issue.
i) Employers Procedures
“Employers Procedures” (as required under Schedule 2 of the regulations) – within these Procedures there needs to be clarity around:
ii) Diagnostic Reference Levels
The Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R) require that employers establish and make available to an operator, Diagnostic Reference Levels (DRLs) and undertake appropriate reviews if they are consistently exceeded.
Report 88 - Guidance on the Establishment and Use of Diagnostic Reference Levels for Medical X-Ray Examinations (2004) written by a Joint Working Party (including College of Radiographers): IPEM, BIR, RCR, NRPB and CoR. The European Medical Exposure Directive and the Ionising Radiation (Medical Exposure) Regulations 2000 place a requirement on departments using ionising radiation for diagnostic purposes to optimise the dose they deliver to patients. This report shows how diagnostic reference levels may be used as a practical tool by departments to develop quality assurance and clinical audit programmes in order to comply with the legislation. This report is available to buy from the IPEM website www.ipem.ac.uk
Patient dose information and typical effective doses, equivalent periods of natural background radiation and lifetime fatal cancer risks from diagnostic medical exposures is available via the Health protection Agency website at: www.hpa.org.uk
iii) Guidance has been written by SCoR, RCN, RCR, CSP, GOC, GCC to help those healthcare practitioners registered with a healthcare regulatory body who wish to take on the role of IR(ME)R 'Referrer' within clinical imaging department. The guidance is available in the policy and guidance document library.
The guidance sets out a policy position on handling this type of request which was agreed by all the contributing organisations and includes legal and professional requirements under IR(ME)R. The IR(ME)R Referrer is required to have a knowledge of IR(ME)R and radiation exposure risks.
Following the publication of this guidance the College of Radiographers developed an IR(ME)R awareness training study day for Nurses and Allied Health Professionals. Similar training is generally available within local diagnostic imaging departments - A typical programme would include: IR(ME)R Referrer Programme.
iv) Examples of IR(ME)R training questions have been written by Maria Murray (Professional Officer for radiation protection) these may be used and modified as required to help radiographic staff gain a better understanding of the IR(ME)R regulations.
IR(ME)R training excercises
v) Guidance for implementing IR(ME)R in radiotherapy is available in the document library here.
This guide will be of benefit to chief executives, medical directors, human resources departments and all professionals involved in the delivery of radiotherapy. This document aims to address a series of frequently asked questions (FAQs) which have come up in formal inspections or have been brought to the attention of the Working Party by its members from their own departments and professions.
vi) Revised IR(ME)R Criteria for Significant Accidental and Unintended Exposures. As of June 3rd 2019, MGTI and PM77 will be revoked and new criteria for statutory notifications under Regulation 8(4) will be published. The IR(ME)R enforcement authority will no longer accept notifications following MGTI or PM77 so please ensure that SAUE criteria is followed. The new notification webform has been carefully constructed to intuitively follow the new criteria. The form and the associated guidance can be found here.
The enforcing authority for Scotland for the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) is the Scottish Ministers. Arrangements for the enforcing authority in Scotland are in a state of change but any IR(ME)R incident Much Greater Than Intended must still be reported and done so to:
Incidents in Wales, which result in a patient receiving a radiation dose "much greater than intended", must be reported, in one of these ways:
By email: [email protected]
Healthcare Inspectorate Wales
Bevan House, Caerphilly Business Park
Van Road, Caerphilly
02920 92 8921
NHS Organisations are also required to inform the Welsh Government of IR(ME)R incidents as part of Serious Incident reporting procedures.
Incidents in Northern Ireland which have gone through a local preliminary investigation and which results in a patient receiving a radiation dose "much greater than intended", must be reported directly to Hall Graham at [email protected]
Information about reporting incidents is available on the CQC website.
A link is there which lists what incidents need to be reported in terms of "much greater than intended" and to the HSE for incidents that involve a medical exposure to a patient through equipment failure.
Notifications can be made directly to CQC by using their web-based notification form.
The IR(ME)R annual report is available here together with IR(ME)R guidance, online notification form, enforcement register and previous reports.
The report provides a breakdown of the notifications of exposures that were ‘much greater than intended’, which were notified to the CQC across all medical radiation modalities during 2016.
The notifications are divided by ‘modality’, which is how they describe the type of radiation exposure, and whether it was received as a result of errors in radiology, nuclear medicine or radiotherapy exposures.
They also present some opportunities for wider learning.
REPPIR aim to protect members of the public from a radiation emergency that could arise from work with ionising radiation. A radiation emergency is an event that is likely to result in any member of the public receiving an effective dose of 5 mSv during the year immediately following the emergency. The regulations may be downloaded here.