The European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 and 2019 provide a framework for regulating medical exposure to ionising radiation in Ireland. HIQA is the competent authority in Ireland with responsibility for inspecting against and enforcing these regulations. This means that we regulate all service providers (undertakings) of medical exposures in Ireland against these regulations. Through monitoring and regulatory programmes, we aim to provide assurances to the public that undertakings are implementing and meeting relevant medical exposures regulations and are making quality and safety improvements that safeguard all service users.
We use regulations to monitor and inspect services which use medical exposure to ionising radiation.
The European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 and 2019 provide a framework for the regulation of medical exposure to ionising radiation in Ireland. Since January 2019, HIQA has been the competent authority in Ireland with responsibility for inspecting and enforcing these regulations. As part of its regulatory function, HIQA is responsible for ensuring that public and private facilities in Ireland providing medical and dental radiological services to people are compliant with the regulations.
HIQA is also responsible for competent authority functions within the legislation, some of which are carried out by the Healthcare Regulation team. These include:
- receipt of significant events related to accidental and unintended exposures
- diagnostic reference levels including establishment and review of national DRLs
- population dose estimation from medical exposures
- dose constraints for carers and comforters
- criteria for acceptability of equipment.
The primary regulations.
The regulations set the minimum standards for the protection of service users when exposed to ionising radiation, which must be met by each undertaking carrying out such practices. However, an undertaking striving to deliver a safe and effective service should constantly seek ways to go beyond the minimum requirements set out in these regulations to promote best practice in radiation protection.
Inspections are carried out to seek assurance that undertakings are in compliance with the regulations.
HIQA carries out inspections in order to assess compliance with the regulations. Before an inspection, HIQA reviews available information on the undertaking and decides what needs to be reviewed on the day of inspection in the medical radiological installation. In order to make judgments about compliance, HIQA may:
- talk with staff and management to find out how they plan and deliver care and services — conversations with management and staff concentrate on their understanding of areas relevant to their work and care they deliver, their experience and training
- observe day-to-day practice to see if it reflects what people have said
- review documents to see if appropriate records are kept and that they reflect practice and what people have said.
HIQA uses a risk-based approach to regulation in accordance with Regulation 25 of S.I. No. 256 of 2018. The risk-based approach means we prioritise our activities based on an assessment of the level of risk in undertakings. HIQA uses information to inform its risk-based approach, and this information may trigger an inspection.
Notify HIQA of a significant event.
Since January 2019, HIQA, as the competent authority for regulating medical exposure to ionising radiation in Ireland, receives incident notifications of significant events arising from accidental or unintended medical exposures. As part of its role, HIQA is responsible for sharing lessons learned from significant events. While a significant event is unwanted, reporting is a key demonstrator of a positive patient safety culture. Reporting is important, not only to ensure an undertaking is compliant but because it improves general patient safety in a service and can minimise the probability of future preventative events occurring.
- Read our guidance document on radiation incident notifications
- Read our recent overview report on radiation incident notifications
- NF211 notification forms
Undertakings should use the HIQA portal system to submit all notifications, alternatively completed notifications maybe submitted via email to email@example.com.
See presentations from information events held by HIQA.
The role of HIQA and undertakings in DRLs.
DRLs are dose levels set to aid optimisation of diagnostic and interventional medical exposures. They provide a standard for comparison to help ensure the radiation protection of patients undergoing these types of medical radiological procedures. Undertakings must ensure that local facility DRLs are established, regularly reviewed and used by persons conducting medical radiological procedures. Undertakings should also ensure that DRL guidance documentation is made available to practitioners, medical physics experts and persons delegated the practical aspects of medical radiological procedures.
- All current national DRLs as adopted and established by HIQA are available in Appendix II, tables 4 to 14 of our guidance document, available here.
- In 2020, HIQA reviewed national DRLs for general radiography and mammography and established national DRLs for dual-energy X-ray absorptiometry (DXA) were produced for the first time in Ireland. To find out more, read our publication here.
- In 2021, HIQA reviewed national DRLs for fluoroscopy and fluoroscopically guided interventions (FGI). To find out more, read our publication here.
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