AUTHOR: LYNDA JOHNSON, SCOR PROFESSIONAL OFFICER
The Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) 2017 (IR(ME)R NI 2018) came into effect on 6 February this year and it has been a regulatory requirement to comply with this legislation since then.
The regulatory bodies recognised that employers needed a period of settling in: following appropriate licencing applications, coming to terms with the new requirements, and making the necessary changes to written procedures would take a little while.
However, it now has been seven months and the Care Quality Commission (CQC) is expecting that employers will have made the required changes.
It is important to note that if organisations were compliant with the previous regulations, IR(ME)R 2000, and had good governance compliance and assurance systems in place, the changes should not have a significant impact.
The Imaging Services Accreditation Scheme (ISAS) Standard published by the Joint Accreditation Scheme Committee of the College of Radiographers and The Royal College of Radiologists highlights the requirements for compliance:
The Leadership and Management Domain criteria (LM1C9) includes a clear responsibility for leaders to have “Systems in place to communicate to staff the need to meet the needs and requirements of users, as well as regulatory, professional and accreditation bodies.”
The Safety Domain (SA1) requires “The service implements and monitors systems to manage risks associated with ionising radiation.” It accepts “A current report demonstrating compliance with statutory requirements from the recognised regulator will be deemed sufficient evidence for relevant criteria.”
SCoR highlighted the key changes in two Synergy News articles at the end of 2017 and in January 2018 along with an overview of the expected guidance that would follow the Department of Health and Social Care Guidance to the Ionising Radiation (Medical Exposure) Regulations 2017, which was published in June 2018.
We also ran a well-attended study day on 8 March 2018 detailing the changes and outlining the guidance that would be developed over the course of the next 12-18 months. We are repeating this event on 4 December 2018 in Birmingham. We continue to receive and respond to specific member queries. The British Institute of Radiology (BIR) has also run study days covering the new regulations.
During the past seven months, the Society has been working with joint professional bodies (JPB) and colleagues at The Royal College of Radiologists, Public Health England, and the Institute of Physics and Engineering in Medicine, as well as having conversations with colleagues at the CQC and the BIR.
We have listened to member concerns in an effort to address common misconceptions. The JPB are working on an agreed, consistent and practical approach to guidance that addresses the key changes. There has been good progress within the SCoR and the working parties to develop guidance across a range of topics that include:
Guidance is intended to support practice across the United Kingdom and serves as an overarching aid for employers and the professions to comply with the law. It is an adjunct to the statutory documents and approved codes of practice and is purposely not prescriptive.
Compliance with the regulations is an employer responsibility. It is not compulsory to follow guidance, but nor is it a defence to delay compliance pending publication of guidance. Regulatory Body Inspectors may refer to guidance where it exists as they seek assurance that an employer is complying with the law.
In an ideal world, all the guidance would have been available on the same day as the regulations came into force but some of these documents took many months to develop and revising them needs to be afforded the same care and consideration. It is also important that we continue to have conversations with our professional body colleagues, our members and our patients, so that we understand and can deliver appropriate support.
We continue to invite anyone interested in joining our collaboration and knowledge-sharing portal Glasscubes to e-mail Lynda Johnson and we will add your name to the list of members keen to communicate by the use of this forum. This is a member led group where members are free to discuss, upload and share information as they wish as long, as they comply with current legislative data protection requirements.
If you have a specific enquiry about the new regulations, please contact the Society's Professional and Education team in the first instance.
The Ionising Radiation (Medical Exposure) Regulations 2017
The Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018
https://www.sor.org/about-radiography/imaging-services-accreditation-scheme-isas (competency document downloads)
Department of Health and Social Care Guidance to the Ionising Radiation (Medical Exposure) Regulations 2017
European Society of Radiology (ESR), 2015, Summary of the European Directive 2013/59/Euratom: essentials for health professionals in radiology
ARSAC notes for guidance: good clinical practice in nuclear medicine
Administration of Radioactive Substances Advisory Committee application forms for employer and practitioner licences under IR(ME)R
Guide to submitting research applications to the Administration of Radioactive Substances Advisory Committee: How and when to submit research applications to ARSAC
ARSAC Support Unit
Telephone: 01235 825006/7