IN SHORT
It is our task to ensure that the hospital trusts comply with the radiation protection regulations.
We administrate every enterprise which uses radiation for medical purposes.
Norwegian healthcare organisations use a variety of radiation sources for diagnostics and treatment. These radiation sources vary from basic X-ray equipment, non-ionising sources such as MRI and laser equipment, advanced X-ray equipment such as CT scanners, linear accelerators and radioactive sources used in the treatment of cancer.
A wide range of organisations and professions also use radiation, including dentists, chiropractors, X-ray institutes and large hospitals. We generally divide these areas into diagnostics, nuclear medicine and radiotherapy.
Radiation sources are used within the healthcare sector for a wide range of purposes, including the medical diagnostics and treatment of patients, in addition to the use of radiation sources in screening programmes for specific diseases, such as breast cancer. The use of radiation for medical purposes is accounting for approximately 25 % of the total population dose from ionising radiation in Norway, excluding radiotherapy.
Authorization
In Norway, we have a legislation which is intended to protect patients, employees and the general public. It is the DSA’s task to ensure that the health trusts comply with the Radiation Protection Regulations.
Most use of radiation within the health care industry requires an authorization under the Radiation Protection Regulations. Enterprises which sell or leasing out equipment which emits radiation, must also obtain an authorization from DSA. In order for an enterprise to be granted such authorization, the organisation must document that it fulfils the requirements in the Radiation Protection Regulation. To assist enterprises in this process, DSA has issued guides containing guidelines and more detailed information on how radiation protection must be addressed.
Inspections and audits
The DSA administrates all activities which use radiation for medical purposes. This administration may involve major audits or more targeted inspections concerning specific subject areas. Depending on the scope, the duration can vary from a brief day-long inspection to an audit which lasts several days. Most of the inspections and audits we carry out in the healthcare sector is pre-announced, but we also carry out unannounced inspections and online inspections.
DSA has established an inspection strategy which states that we must carry out risk-based inspections. This means that we must carry out inspections where the risks are the greatest (graded approach).
Topics which we often focus on during inspections and audits include:
- Organisation of radiation protection within enterprises
- Health, Safety and Environmental (HSE) work within the field of radiation protection and the implementation of radiation protection measures in internal control
- Expertise and resources within medical physics
- Medical expertise
- Radiation protection expertise
- Training in radiation protection, radiation use and equipment-specific training
- Justification and optimisation
- Quality assurance system and non-conformity reporting (accidents and incidents)
- Quality control and equipment maintenance
During the inspection, we sometimes identify circumstances which are not in accordance with the applicable regulations. We call this a ‘non-conformity’. Non-conformities must be remedied by an agreed deadline. Sometimes we provide notes/remarks concerning circumstances which we believe should be pointed out but are not actual breaches of law. After the audit or inspection, we will prepare a written report. We publish this report on our Norwegian web site.
Guidelines
As an aid for enterprises on how they can comply with the requirements laid down in the radiation protection regulations, guides have been prepared within most areas of medical radiation use. Available in Norwegian only.
- Guideline no. 5 Guidance for use of medical X-ray and MRI equipment
- Guideline no. 6 Guidance for radiotherapy
- Guideline no. 10 Guidance for nuclear medicine
- Guideline no. 14 Guidance for the use of radiation within odontology
The electronic registration system for radiation sources
Most radiation sources must be registered via DSA’s registration system for radiation sources.