Radiation and Nuclear Safety Authority Regulation on a Plan for Radiation Safety Deviations and Actions During and After Radiation Safety DeviationsSTUK S/8/2024

PDF

In accordance with a decision of the Radiation and Nuclear Safety Authority, the following provisions are issued by virtue of sections 129, subsection 2; section 130, subsection 7; and section 131, subsection 5 of the Radiation Act (859/2018):

Section 1 Limitation of scope of application

This Regulation shall not apply to the use of nuclear energy referred to in the Nuclear Energy Act (990/1987), use of non-ionizing radiation, or practice of aviation subject to a safety licence.

Only the requirements laid down in section 2, subsection 1 and section 8 shall apply to radiation practices subject to a safety licence if the radiation practice concerns:

  1. dental X-ray imaging using a panoramic tomography X-ray equipment, cephalostat, or dental X-ray equipment for imaging with an intraoral imaging receptor;
  2. an examination conducted with a bone mineral content measurement appliance;
  3. veterinary X-ray examinations conducted with a dental X-ray equipment;
  4. use of closed beam analysers, shielded fluoroscopic devices or other similar shielded X-ray equipment.

Section 2 Plan for radiation safety deviations

A plan for preparedness for radiation safety deviations shall include a procedure for recording the course of events, actions for determining the magnitude of the radiation exposure, procedure for notifying the event and, and if necessary, the procedure for obtaining advice from a radiation safety expert or medical physics expert. The plan shall include separate actions for facility and place where the radiation is used if different procedures are followed at different places of use.

The plan shall include immediate actions for limiting radiation exposure for those identified radiation safety deviations in which the exposure can be limited by actions taken after the event.

The plan must include actions for organising the special medical surveillance referred to in section 97 of the Radiation Act if radiation safety deviations have been identified that may result in a dose that exceeds the dose limit for workers.

The plan must include procedures for submitting the notification referred to in section 7, subsection 2.

Section 3 Exercises in actions set out in the plan

If preventing or mitigating the consequences of a radiation safety deviation by means of immediate actions is possible, those involved in the practice shall participate in exercises in these actions as required by their duties.

The appropriate interval between the exercises shall be determined by the undertaking. The interval between the exercises shall be no more than one year if the exercise concerns a radiation safety deviation which results in category 1 exposure to workers or the public and which is not a highly unlikely event, or if the practice involves administering brachytherapy with a high-activity sealed source.

Section 4 Significant unplanned medical exposure

Unplanned medical exposure significant in terms of its clinical impacts comprises events that have caused at least a moderate detrimental effect in the exposed person, or a physician has otherwise assessed the event as being clinically significant.

According to dosimetric criteria, an event entails significant unplanned medical exposure if:

  1. in radiotherapy with a device which produces radiation electrically and with sealed sources
    1. the total dose administered to the treatment target or reference point deviates from the planned dose by more than 10% and the deviation is greater than 4 Gy;
    2. the systematic deviation of the dose administered to the treatment target or reference point exceeds 5% of the total dose;
    3. the unplanned dose to an organ at risk exceeds the locally determined tolerance dose for this organ by over 10% during the entire period of treatment;
    4. a deviation from the treatment date set out in the treatment plan occurs where the interruption in treatment is more than one week and the deviation is not due to the patient;
    5. the patient, treatment target or treatment plan is wrong;
  2. in treatments provided with a radiopharmaceutical and a medical device using an unsealed source
    1. the activity received by the patient deviates by more than 30% from the planned activity;
    2. the activity received by the patient systematically deviates by more than 15% from the planned activity;
    3. the effective dose received by the patient from treatment-related contamination exceeds 10 mSv, or the equivalent dose to an organ exceeds 100 mSv;
    4. the patient, treatment target, treatment plan or radiopharmaceutical is wrong;
  3. in medical exposure category 1 or 2 practices, in an examination or procedure using X-rays and radiopharmaceuticals
    1. the additional effective dose received by the patient or a wrong patient is at least 10 mSv;
    2. at least 10 patients are subjected to systematic deviating exposure and the average magnitude of this exposure deviates from the planned exposure by at least 50%, or the additional effective dose caused by the event is at least 1 mSv;
  4. exposure caused to a healthy volunteer by scientific research exceeds the set dose constraint;
  5. the additional effective dose received by a carer and comforter due to unplanned exposure exceeds 1 mSv or the equivalent dose received by an organ exceeds 10 mSv;
  6. an unplanned dose absorbed by a foetus is at least 10 mGy.

Unplanned exposure significant for other reasons includes events involving:

  1. a near miss that is detected outside quality control measures and that could potentially have met a criterion set out in subsections 1 and 2;
  2. recurring events which do not meet the criteria set out in subsections 1 and 2 but which could potentially cause a clinically significant event;
  3. other medical exposure of which it is important to inform other undertakings to avoid the occurrence of similar radiation safety deviations.

Section 5 Notifying a radiation safety deviation to the Radiation and Nuclear Safety Authority by telephone

An undertaking shall notify a radiation safety deviation to the Radiation and Nuclear Safety Authority by telephone in the following cases:

  1. a radiation safety deviation has led to an emergency exposure situation;
  2. the dose limit for workers or the public has been exceeded as a result of the radiation safety deviation;
  3. a radiation source containing a radioactive substance for which a safety licence is required has been lost or subjected to an illegal act;
  4. a potentially hazardous radiation source has been lost or discovered;
  5. significant spread of a radioactive substance has occurred indoors or in the environment;
  6. any other abnormal observations or information that require immediate action to ensure radiation safety.

An event that occurs during office hours shall be notified on the same day, and one that occurs after office hours shall be notified on the following working day.

If the event requires action by the rescue services, emergency medical care services or the police, the Emergency Response Centre shall be notified.

Section 6 Notifying a radiation safety deviation to the Radiation and Nuclear Safety Authority in writing

An undertaking must submit a notification made by telephone referred to in section 5, subsection 1 to the Radiation and Nuclear Safety Authority in writing without delay.

Other radiation safety deviations that require immediate notifying referred to in section 130, subsection 2 of the Radiation Act shall be notified in writing as soon as possible, however no later than within two weeks of the radiation safety deviation being detected.

The written notification shall include:

  1. the name of the undertaking and the number of the safety licence;
  2. the name and contact details of the person responsible for handling the radiation safety deviation;
  3. the name and contact details of the person who submits the notification;
  4. the time and place of the event;
  5. key information on the radiation source;
  6. a description of the radiation safety deviation;
  7. information on those who may have been exposed and their exposure to radiation; if no radiation dose measurement results are available, the dose shall be estimated based on the available exposure data;
  8. an assessment of radioactive substances which may have been released to the environment;
  9. immediate action taken;
  10. initial assessments of the causes of the radiation safety deviation;
  11. parties notified of the event.

Section 7 Notifying individuals involved in the event of a radiation safety deviation

A notification referred to in section 130, subsection 3, paragraphs 1 and 3 of the Radiation Act shall be given if the exposure caused by a radiation safety deviation exceeds the dose limit or the dose constraint in use.

A notification referred to in section 130, subsection 3, paragraph 2 of the Radiation Act shall be given of clinically significant exposure caused by a radiation safety deviation referred to in section 4, subsection 1.

Section 8 Radiation safety deviations subject to notification of summarized information

Summarized information on radiation safety deviations other than those referred to in section 130, subsection 2 of the Radiation Act shall be submitted annually to the Radiation and Nuclear Safety Authority.

Any radiation safety deviations concerning the previous calendar year shall be notified to the Radiation and Nuclear Safety Authority by 1 February.

At minimum, the notification of summarized information shall include the information specified in Annex 1, Table 1 on occupational exposure, the information specified in Annex 1, Table 2 on public exposure, and the information specified in Annex 1, Tables 3a or 3b on unplanned medical exposure.

Section 9 Investigation of a radiation safety deviation

The results of an investigation of a radiation safety deviation referred to in section 130, subsection 2 of the Radiation Act and any remedial measures shall be notified no later than two months after the radiation safety deviation was detected.

The notification referred to in subsection 1 above shall include the information referred to in section 6, subsection 3, supplemented with details of the event or observation, as well as more detailed information on the causes and consequences of the radiation safety deviation. In addition, the investigation notification shall set out the measures taken to prevent the recurrence of similar radiation safety deviations.

It is sufficient to notify the results of investigations of radiation safety deviations other than those referred to in section 130, subsection 2 of the Radiation Act and remedial measures as part of the annual summarized information referred to in section 8.

Section 10 Entry into force

This Regulation enters into force on 1 January 2025 and is valid until further notice.

This Regulation applies to any matters pending on the date of its entry into force.

This Regulation repeals the Radiation and Nuclear Safety Authority Regulation on a Plan for Radiation Safety Deviations and Actions During and After Radiation Safety Deviations (STUK S/2/2018).

Section 11 Transitional provision

Section 6, subsection 3 of the Regulation to be repealed shall apply to the submission of summarised information concerning 2024, instead of section 8, subsection 3 of this Regulation.

In Vantaa on 15 November 2024

Council Directive 2013/59/Euratom (32013L0059); OJEU L 13, 17.1.2014, p. 1

Reported to the Commission in accordance with Article 33 of the Treaty establishing the European Atomic Energy Community.

ANNEX 1

ANNEX 1