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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.
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 22 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.
Read all three inspection reports at www.hiqa.ie