Ionising radiation services publication statement 19 May 2021
The Health Information and Quality Authority (HIQA) has published three reports of inspections assessing compliance with medical exposure to ionising radiation regulations at Owgar Limited, as responsible undertaking for the X-ray service at Clontarf Chiropractic. Medical exposure to ionising radiation is when radiation is used as part of diagnosis such as an X-ray or CT scan, or the use of radiotherapy as part of cancer treatment at a hospital. It also includes radiation received for medical research purposes and radiation received by carers and comforters while attending to a patient.
Three risk-based inspections were carried out between December 2019 and March 2021 after Owgar Limited submitted a self-assessment questionnaire to HIQA that identified areas of non-compliance. These non-compliances related to the absence of key personnel required for the conduct of medical exposures as required by the regulations.
During the first unannounced inspection in December 2019, these findings of non-compliances were validated on inspection. A further inspection in September 2020 found that while Owgar Limited had taken some immediate action to address the non-compliances identified on inspection, including the temporary closure of the service until such time as a registered radiographer was employed to take X-rays, inspectors were not satisfied that full compliance was addressed in a timely manner. Following this inspection, a decision was taken to issue HIQA’s first enforcement order under Section 26 of the European Union (Basic Safety Standards for Protection against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 and 2019.
A compliance notice was issued to Owgar Limited directing it to comply with key regulations relating to governance responsibility, assignment of trained and recognised professionals within the service to include a referrer, practitioner and medical physics expert and the establishment of diagnostic reference levels for typical X-ray examinations by the 22nd January 2021. A follow-up inspection was carried out in March 2021 to verify that Owgar Limited had addressed the non-compliances identified in the compliance notice. HIQA found that Owgar Limited had taken considerable action to come into compliance with the regulations. Actions taken by Owgar Limited included the engagement of additional expertise within the service, to include a registered medical physics expert and a registered radiologist. In addition, information provided to HIQA in advance of the inspection as part of a diagnostic reference level survey request indicated that diagnostic reference levels for general X-rays provided at the service had been established and were found to be below or comparable to national diagnostic reference levels demonstrating an ability to optimise patient radiation dose. Overall, Owgar Limited had provided an assurance to HIQA that it had adhered to the directions of the compliance notice.
Notes to Editor:
- HIQA is the competent authority for patient protection in relation to medical exposure to ionising radiation in Ireland after the EU’s Council Basic Safety Standards (BSS) Directive of 2013 was transposed into Irish law in 2019. These inspections were carried out between August and November 2020.
- The Environmental Protection Agency (EPA) continues, under separate ionising radiation regulations, to be the competent authority for the protection of workers and members of the public. HIQA and the EPA work together to carry out their separate but parallel functions under the relevant legislation.
- An undertaking is a person or body who has the legal responsibility for carrying out, or engaging others to carry out, a medical radiological practice, or the practical aspects of a medical radiological procedure, as defined by the regulations.
- A practitioner is a registered doctor, dentist, radiographer or radiation therapist who can take clinical responsibility for an individual medical exposure.
- Medical physics expert is a person who has the knowledge, training and experience to advise on matters relating to radiation physics applied to medical exposure procedures.
- Diagnostic reference levels are estimates of representative radiation dose levels for typical X-ray examinations.