Table of contents
- Section 1 Limitation of scope of application
- Section 2 Plan for radiation safety deviations
- Section 3 Operating instructions for each place of use
- Section 4 Significant unintended medical exposure
- Section 5 Reporting a radiation safety deviation
- Section 6 Radiation safety deviations subject to notification of summarized information
- Section 7 Report on a radiation safety deviation
- Section 8 Entry into force
- ANNEX 1
In accordance with a decision of the Radiation and Nuclear Safety Authority, the following provisions are issued by virtue of sections 129, subsection 2, 130, subsection 6 and 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 as referred to in the Nuclear Energy Act (990/1987) and to the use of laser equipment.
Section 2 Plan for radiation safety deviations
The plans for radiation safety deviations shall include separate operating instructions for each place of use in the event of a radiation safety deviation.
The plan shall include training and exercises on the immediate actions to be taken to limit radiation exposure.
Additionally, the plan shall specify measures for determining the causes of a radiation safety deviation and for learning from it.
Section 3 Operating instructions for each place of use
In a practice of category 1 radiation exposure, each place of use shall have written operating instructions in place that are available to the workers. The operating instructions shall at least specify:
- the immediate measures to be taken to limit radiation exposure, including:
- identifying and limiting the radiation hazard area;
- preventing outsiders from accessing the radiation hazard area;
- the use of respirators if it is suspected that radioactive substances have entered into the breathing air;
- prevention of the dispersion of contamination;
- notifying the radiation safety officer of the radiation safety deviation;
- prevention of the accumulation of radioactive iodine into the thyroid gland;
- accelerating the decorporation of radionuclides;
- removal of sealed source radiotherapy appliance from the patient;
- removal of the patient from the radiation beam;
- the procedure for recording the course of events, including:
- the measures carried out and the times thereof;
- the names and contact information of the individuals who were exposed or otherwise involved in the radiation safety deviation and, concerning workers, the information referred to in section 42 of the Government Decree;
- detailed information concerning the exposure;
- the procedure for reporting a radiation safety deviation:
- to competent authorities;
- to those involved in the radiation safety deviation;
- the actions for determining the magnitude of the radiation exposure;
- the urgent actions for assessing the state of health of those who were exposed;
- instructions for informing the patient and his or her attending physician;
- the procedure for obtaining advice from a radiation safety expert and medical physics expert.
In a practice of radiation exposure categories 2 or 3, each place of use shall have written operating instructions in place that are available to the workers, and at least the information referred to in paragraphs 1, 2, 3, 4 and 7 of subsection 1 shall be included in the operating instructions.
Section 4 Significant unintended medical exposure
The unintended medical exposure is significant if:
- the dose caused to the patient by electron or photon radiation generated with radiotherapy appliance deviates or could have deviated from the planned total dose by at least 25%;
- the dose caused to two or more successive patients by electron or photon radiation generated with radiotherapy appliance deviates or could have deviated from the planned total dose by 5–25%;
- the activity received by the patient in radionuclide therapy deviates or could have deviated from the planned activity by at least 25%;
- the activity received by two or more successive patients in radionuclide therapy deviates or could have deviated from the planned activity by 10–25%;
- a wrong patient is exposed when the medical exposure is of category 1;
- the additional effective dose caused to the patient or to a wrong patient by the examination or procedure is at least 10 mSv;
- the examination, procedure or treatment causes deterministic detriment to the patient as a result of additional radiation exposure;
- the absorbed dose caused to the foetus as a result of additional exposure is at least 10 mGy;
- systematic additional exposure is caused to at least 10 patients and the exposure of a single patient is at least 50% higher than in a planned exposure in a practice of 1 or 2 medical exposure;
- at issue of other medical exposure of which it is important to inform other operators to avoid the occurrence of a similar radiation safety deviation.
Section 5 Reporting a radiation safety deviation
The notification referred to section 130, subsection 2 of the Radiation Act shall be made by telephone or using other such means of communication with which the notifying party can ensure that the message has been duly received.
Outside of regular office hours, the Radiation and Nuclear Safety Authority shall be contacted by calling the emergency response centre.
The notification shall include:
- the name of the undertaking and the number of the safety licence;
- the name of the radiation safety officer;
- the name and contact details of the individual who submits the notification;
- the time and place of the event;
- the radiation source;
- description of the radiation safety deviation;
- information about 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;
- an assessment of radioactive substances which may have been released to the environment;
- the immediate measures taken;
- initial assessments of the cause of the radiation safety deviation.
A notification made orally shall be confirmed in writing without delay.
Section 6 Radiation safety deviations subject to notification of summarized information
The summarized information referred to in section 131(4) of the Radiation Act shall be notified to the Radiation and Nuclear Safety Authority in aggregate form on an annual basis.
The radiation safety deviations concerning the previous calendar year shall be notified to the Radiation and Nuclear Safety Authority by 1 February.
The notification of summarized information in aggregate form on radiation safety deviations concerning unintended medical exposure shall include at least the information specified in Table 1 of Annex 1.
Section 7 Report on a radiation safety deviation
A written report shall be prepared on the radiation safety deviation that includes the information referred to in section 5, subsection 3 above completed with the details of the event or observation and more detailed information on the causes leading to the radiation safety deviation and the resulting effects. Additionally, the report shall specify measures for preventing the occurrence of similar radiation safety deviations.
The undertaking shall submit the report referred to in subsection 1 above to the Radiation and Nuclear Safety Authority without delay.
Section 8 Entry into force
This regulation enters into force on 15 December 2018 and is valid until further notice.
This regulation applies to any matters pending on the date of its entry into force.
In Helsinki on 14 December 2018
Table 1. Radiation safety deviations concerning an unintended medical exposure to be notified in aggregate form.
|Type of radiation safety deviation||Cause and factor contributing to the occurrence of a radiation safety deviation||Number of radiation safety deviations per year|
|Referral made for a wrong person, as a result of which a wrong person was exposed to radiation||Human error|
|Wrong examination, procedure or anatomical object in the referral, which resulted in incorrect examination or procedure||Human error|
|Examination or procedure carried out on a wrong person||The patient’s identity was not verified by reliable means prior to the examination or procedure|
|A wrong examination or procedure was carried out or a wrong anatomical object was scanned||Human error|
|Failed examination or procedure (other than injection of a radiopharmaceutical or contrast medium) or additional exposure related to them||Incorrect or deficient operating instructions|
|Isolated appliance or system failure|
|Systematic appliance or system failure|
|Failed injection of radiopharmaceutical or contrast medium||Human error|
|Technical fault in equipment or device|
|Unnecessarily repeated examination||No information about the similar examination previously carried out or the results of the previous examination unavailable|
|Inadvertent exposure of foetus||Pregnancy in such an early stage that it could not be verified|
|Possibility of pregnancy not verified in a reliable manner prior to the examination or procedure|
|Additional exposure of carers and comforters||Human error|
|Incorrect or deficient operating instructions or failure to observe the instructions|
|A near-miss incident resulting from the same cause more than once||Error in conduct of operations|
|Error in system or appliance|
|Other radiation safety deviation related to medical exposure||Other cause|
Council Directive 2013/59/Euratom (32013L0059); OJEU L 13, 17.01.2014, p. 1
Reported to the Commission in accordance with Article 33 of the Treaty establishing the European Atomic Energy Community