Published: 2014-07-01
Key Benefits:
Passed 15.05.2014 Annex 29
The regulation is established on the basis of § 51 of the Radiation Act.
The regulation sets forth the requirements for the protection of a person against the hazards of ionising radiation during medical radiology procedures.
The following terms are used for the purposes of this regulation:
1) dosage restriction – maximal permitted effective dosage for an individual, which is determined by optimising the procedure performed with certain medical radiation equipment;
2) approval tests – tests directly preceding the start of using a medical radiation device for the first time or after its reconstruction to verify the safety and performance indicators prescribed for the device and to determine the base values of the performance indicators;
3) radiation protection equipment – personal protection equipment used in medical radiology procedures to protect an individual undergoing radiation against the undesired damaging effects of radiation;
4) assistant to an individual undergoing radiation – a person who knowingly and willingly (other than a part of his or her work) helps a patient undergoing medical radiation during a medical radiology procedure;
5) a specialist of medical physics – a person who has a professional certificate of an engineer of biomedical technology;
6) medical radiation device – a device emitting or registering ionising radiation used in medical radiology procedures;
7) clinical audit of medical radiology procedures (hereinafter ‘clinical audit’) – systematic review of the clinical performance of the use of medical radiation, inter alia, of the medical radiology practices for the purpose of safety and enhanced quality, and comparison with the standards of good practices, and where relevant, changing the practices or updating the standards;
8) quality manual – documents describing the quality system of radiation safety;
9) patient dosage – dosage of the patients undergoing medical radiation or other examined persons;
10) radiology technician – a person who has professional higher education or a person who has the professional certificate of a radiology technician;
11) reference value – reference level of a patient dosage or activity of a radio-pharmaceutical drug for a patient of a standard size, which is used for the purpose of optimising the patient dosage;
12) standard procedure – a diagnostic medical radiology procedure regarding which a reference value is determined;
13) a patient of standard size – an imaginary patient weighing 70±3 kg whose average patient dose calculated for him or her is compared with the reference value;
14) functioning tests – tests regularly conducted during the use of a medical radiation device to verify the safety and functioning indicators of the medical radiation device.
(1) The direct benefits from performing a medical radiology procedure for human health and society must outweigh the potential damage resulting from exposure of a person to radiation (requirement of the justifiability of the use of the medical radiation). Any unjustified performance of a medical radiology procedure shall be prohibited.
(2) Before performing a medical radiology procedure, an alternative method suitable for the achievement of the same clinical objective shall be considered, including the option of using a method that does not involve medical radiation.
(3) When performing a medical radiology procedure, the radiation dosage shall be kept as low as possible and reasonable to achieve the objective of the procedure (requirement of the optimisation of diagnostic medical radiation). When using medical radiation for therapeutic purposes, the radiation dosage shall be administered to the target tissue on an individual basis, while keeping the radiation dosage around the target tissue as low as possible to achieve the objective of radiation therapy (the requirement of the optimisation of therapeutic medical radiation).
(4) The requirement of the optimisation of therapeutic medical radiation includes the selection of an appropriate medical device, ensuring the regularity of the medical radiology procedure, and evaluation of the activity of the patient dose or administered radio-pharmaceutical drug.
(5) No dosage restrictions are applied to the medical radiation of a patient. A holder of the licence for radiation activity shall establish dosage restrictions for an assistant to a person undergoing radiation or a person voluntarily participating in a scientific study where for these persons the direct benefits from the use of medical radiation are not certain.
(6) If the proposed dosage restriction of an assistant to a person undergoing radiation is higher than 5 mSv, or if the dosage restriction of a person voluntarily participating in a proposed scientific study is higher than 10 mSv, the dose restriction shall be coordinated with the Health Board.
(7) A holder of the licence for radiation activity for radiation activity shall collect the following information about procedures:
1) The number of procedures performed during a year in accordance with the list of procedures set out in Annex 1 (procedure, projection / methodology);
2) The average patient dosages for a patient of a standard size broken down to standard procedures and medical radiation devices provided for in Annex 2.
(1) A patient is referred to a medical radiology procedure by a physician or dentist or any other health professional under the guidance and responsibility of a physician or dentist.
(2) The person referring a patient to a medical radiology procedure shall ensure the justifiability of the procedure, taking into account the available health data of the patient and previous procedures for the purposes of ensuring compliance with the requirements of §3 (1).
(3) Special attention to the justifiability of a medical radiology procedure shall be paid while planning of procedure for a child or adolescent under 15 years of age, a pregnant or breastfeeding woman, including evaluation of the need for immediate performance of the procedure. Women of childbearing age shall be asked about potential pregnancy and duration of the pregnancy when planning a procedure.
(4) The person referring a patient to a medical radiology procedure shall ensure that the patient is informed about the need for the procedure and about the risk of radiation damage and about the preparation of the patient for the procedure for the purposes of ensuring the effectiveness of the procedure and compliance with the requirements of §3 (1) of the regulation.
(5) The person referring a patient to a diagnostic medical radiology procedure shall describe the health problem of the patient in the referral note, formulate the clinical question for which an answer is sought, and reflect the results of earlier studies that are important in terms of the problem being solved. If necessary, the person referring a patient to a procedure shall include in the referral note necessary information on the patient, such as any medical devices implanted in the body, information about drug allergies, intercurrent diseases or therapy, and the like.
(6) In planning a diagnostic medical radiology procedure, it shall be proceeded from the radiation protection guidelines of the European Commission and the good radiology practices regarding referrals to medical radiology procedures. The Health Board shall publish the guidelines on its website.
(1) A medical radiology procedure shall be performed by a radiologist or another physician properly trained to evaluate the justifiability of and perform the procedure, or a radiology technician or another radiation staff under the guidance of a radiologist or a physician who has been trained to perform the relevant procedure.
(2) The person performing a medical radiology procedure shall ensure the justifiability and optimisation of the procedure, taking into account the health data of the patient and earlier procedures that are critical in terms of the selection of the procedure and methodology available to the person in order to avoid unjustified use of medical radiation and to ensure the lowest reasonably possible radiation dosage.
(3) The person performing a diagnostic medical radiology procedure may modify the procedure specified in the referral note, if the same result is achievable by another procedure which, in terms of the radiation burden or health of the patient, is more purposeful, or abandon the procedure, notifying the person who referred the patient to the procedure about it.
(4) Before performing a medical radiology procedure, the person performing the procedure shall inform the person undergoing radiation and his or her assistant about the course of the procedure and proper methods of assistance, ensure that the person undergoing radiation and his or her use radiation protection equipment.
(5) For radiation therapeutic purposes, exposures of target volumes shall be individually planned by the physician providing radiation therapy. An individual treatment plan shall be prepared for each patient to ensure that the requirement of the optimisation of therapeutic medical radiation specified in §3 (1) of the regulation is met.
(6) A specialist of medical physics shall be involved in optimising medical radiology procedures, being:
1) directly involved in the planning and performing of radiation therapy procedures;
2) involved, if necessary, in the planning and performing nuclear medicine procedures;
3) available, if necessary, for other medical radiology procedures to optimise radiation dosages, ensure quality, and advise on radiation safety.
7) A person who is administered radio-pharmaceutical drugs or undergoing radiation therapy is provided by the person performing the medical radiology procedure with written instructions on the avoidance of potential side-effects of ionising radiation and recommendations for their prevention or mitigation. Instructions will be provided and the contents shall be explained to the person or his or her close relatives before leaving the provider of health care services.
(8) In finalising the results of a medical radiology procedure, it shall be proceeded from the list of procedures set out in Annex 1 (procedure, projection / methodology).
(9) The result of a diagnostic medical radiology procedure shall be finalised as a written response to the referral note in which the radiologist describes the findings of the study, including standard findings, probable main cause of the clinical problem and other possible causes, and recommended further studies. Information on the time of the procedure and changing or abandoning the procedure specified in the referral note, as appropriate, shall be added to the result.
(10) A holder of the licence for radiation activity shall maintain a referral note to the diagnostic medical radiology procedure and the response with an image, in a format which can be reproduced, for at least five years.
(11) For a therapeutic medical radiology procedure involving the use of medical radiation or radio-pharmaceutical drugs, the radiation dosage or the activity of the administered radio-pharmaceutical activity shall be set out in the patient's medical records.
(1) The medical radiation devices used in medical radiology procedures shall comply with the criteria presented for medical radiation devices in the radiation protection guidelines of the European Commission. The Environmental Board shall publish the guidelines on its website.
(2) A holder of the licence for radiation activity shall ensure proper installation of medical radiation devices and the terms of use prescribed by the manufacturer. It is prohibited to use, in medical radiology procedures, medical radiation equipment that has not undergone approval and functioning tests and that is not fit for a safe and effective procedure.
(3) In order to ensure radiation safety, a holder of the licence for radiation activity shall ensure, in performing medical radiology procedures to ensure, inter alia:
1) in performing X-ray inspection and CT angiography studies, use of a medical radiation device whose image receptor is an electron-optical amplifier, fully digital flat detector or other equivalent equipment, allowing the image to be registered in impulse fluoroscopy mode;
2) in performing a computer tomography study, use of a medical radiation device, which allows automatic modulation of the tube flow in order to take into account the particularities of the person undergoing medical radiation;
3) in acquiring new medical radiation devices, choice of a device, which allows registration of the value of the dosimetric amount characterising the radiation emitted by the device and archive it along with the image data;
4) in studies of children and adolescents of 15 years of age, use of appropriate medical radiation devices and ancillary devices, which enable optimisation of medical radiation.
(4) Before starting to professionally use a medical radiation device, a holder of the license for radiation activity shall perform an approval test and during use of the device – regular functioning tests in accordance with the radiation protection guidelines of the European Commission and recommendations of the manufacturer of the device unless otherwise specified in the conditions of the licence for radiation activity.
(5) The approval and operating tests may be performed by:
1) a specialist of medical physics employed by a provider of health care services holding a licence for the radiation activity, while meeting the conditions of the quality system for radiation safety, or
2) a person authorised by the manufacturer, or
3) a laboratory accredited in the relevant measurement area.
(6) A holder of the licence for radiation activity shall ensure that radiation staff is trained on the radiology procedures performed on medical radiation devices and availability of understandable operating manuals regarding medical radiology procedures.
(7) In preparing the operating manuals regarding medical radiology procedures, the medical radiation devices in use, list of procedures set out in Annex 1 (procedure, projection / methodology) shall be taken into account. The operating manual describes the principles of selecting a procedure, indications, contraindications and warnings, requirements for the preparation of a procedure, indications of a repeat procedure, methodology for performing a procedure (including use of radiation protection equipment), criteria of a quality procedure (including requirements for the quality of imaging), and methodology of procedure description.
(1) A holder of the licence for radiation activity shall collect the following data for at least ten patients over 15 years of age weighing from 65 to 75 kg (whose average weight corresponds to the weight of a standard patient) in one year:
1) weight of the patient;
2) height of the patient;
3) sex of the patient;
4) age of the patient;
5) patient dose.
(2) In addition to the data referred to in subsection 1, data about the procedures that have been performed, equipment and imaging shall be recorded on the basis of Annex B to the guidelines "Guidelines for evaluating the patient dosage in medical radiology procedures". The Health Board shall publish the guidelines on its website.
(3) The data referred to in subsections 1 and 2 above shall be collected for all standard procedures and the medical radiation devices routinely used in performing them specified in Annex 2 to this regulation.
(4) A holder of the licence for radiation activity shall calculate, based on the collected data, average patient dosages of standard procedures once a year.
(5) For standard procedures performed in dental therapy (dental x-rays or ortopantomography), the holder of the licence for radiation activity shall record during the year one patient dosage for the setting corresponding to a patient of a standard size.
(1) A holder of the licence for radiation activity shall implement the quality system for radiation safety in performing medical radiology procedures, which is documented in the quality manual.
(2) Data specified in Annex 3 to the regulation shall be presented in the quality manual.
(3) A holder of the licence for radiation activity shall maintain the data and documents included in the quality manual for at least 10 years.
(4) A holder of the licence for radiation activity shall, at least once a year, organise an in-house clinical audit, involving relevant performers of medical radiology procedures and a specialist of medical physics.
(5) In planning and performing a clinical audit, it is proceeded from the guidelines of radiation protection of the European Commission regarding clinical audits. The Health Board shall publish the guidelines on its website.
(6) During a clinical audit, the medical radiology procedures that have been performed shall be compared with the requirements and operating manuals of those procedures, evaluating the compliance of medical radiation devices, radiation staff and activities with requirements and operating manuals.
(7) The result of a clinical audit shall be finalised as a written report, recording the names of the persons who performed the audit, the time, objectives and methodology of performing the audit (including a list of the used data), problems and irregularities identified during the audit, final evaluation and recommendations regarding the effectiveness of using medical radiation, including enhancement of its safety and quality.
(8) A clinical audit report shall be prepared within three months after performing the audit.
(9) A holder of the licence for radiation activity shall, according to the recommendation of the clinical audit, supplement or improve the quality system for radiation safety, organise training of radiation staff or staff planning medical radiology procedures or organise other relevant actions to improve the clinical effectiveness of the use of medical radiation.
(1) A specialist of medical physics specified in clause 2 5) shall have a professional certificate of an engineer of biomedical technology at the latest by 1 June 2015.
(2) Medical radiation devices shall comply with the requirement to register images in impulse fluoroscopy mode specified in clause 6 (3) 1) at the latest by 1 June 2015.
(3) This Regulation shall enter into force on 1 July 2014.
(4) Subsection 3 (7) of this Regulation shall enter into force on 1 July 2015.
Helmen Kütt
Minister of Social Affairs
Helen Tralla
Acting as the Secretary General
Annex 1 List of medical radiology procedures
Annex 2 List of standard procedures
Annex 3 Data to be included in the quality manual
