Section 67: Regulatory Control for Medical Exposure
199. This regulation shall apply to the following medical exposures, including intended, unintended, and accidental exposures:
(a) To patients as part of their medical diagnosis or treatment;
(b) To individuals as part of a health screening program;
(c) To patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programs;
(d) To carers and comforters;
(e) To asymptomatic individuals;
Section 68: Justification of medical exposures
200. The medical exposure is justified if it can be proved that the total potential diagnostic or thera-peutic benefits to the health of an individual and the benefits to society are higher than the radia-tion detriment the exposure might cause. The benefits and risks connected to available alterna-tive techniques with the same objective, involving less or no exposure to ionizing radiation, shall be evaluated.
201. The authorized person for the proper implementation of the justification principle, as outlined in Article 200, when considering the use of a radiological procedure on patients, shall ensure that:
(a) The concerned radiological procedure with a specified objective is justified;
(b) The justification for an individual patient is carried out by means of consultation between the radiological medical practitioner and the referring medical practitioner, as appropri-ate, with account taken, in particular for patients who are pregnant or breast-feeding or are pediatric, of:
(i) The appropriateness of the request;
(ii) The urgency of the radiological procedure;
(iii) The characteristics of medical exposure;
(iv) The characteristics of the individual patient;
(v) Relevant information from the patient's previous radiological procedures.
202. Where there is to be an exposure to a carer or comforter, the authorized person shall ensure a sufficient net benefit of exposure, taking into account:
(a) The likely direct health benefits to a patient;
(b) The possible benefits to the carer or comforter;
(c) The detriment that the exposure might cause.
203. Where radiological procedures are planned to be performed as part of a health screening pro-gram for asymptomatic populations, the authorized person responsible for such studies shall en-sure that the relevant program and involved procedures are documented and justified.
204. The authorized person shall ensure that any radiological procedure on an asymptomatic individu-al that is intended to be performed for the early detection of disease, but not as part of an ap-proved health screening program, is previously documented, evaluated, and justified by the radi-ological medical practitioner and the referring medical practitioner, in accordance with the de-fined requirements.
205. Whether a program of biomedical research that includes medical exposure of volunteers is con-sidered justified by the authorized person responsible for such a program, this authorized person shall apply for a specific authorization before starting its implementation.
Section 69: General Requirements for the Personnel with Responsibilities for Medical Radiological Exposures
206. The authorized person shall allow health professionals to assume responsibilities for medical ex-posure at a particular medical radiation facility as prescribed in this regulation only if they:
(a) Posses degree of specialization in the appropriate area according to the established na-tional criteria;
(b) Posses the respective requirements for education, training and competence in radiation protection prescribed by the NRRC;
(c) Named and listed in the updated list of qualified personnel.
Section 70: Primary Requirements for the Control of the Medical Radiological Exposures of a Patient
207. The authorized person shall ensure that no patient, whether symptomatic or asymptomatic, un-dergoes a medical exposure unless:
(a) The radiological procedure has been requested by a referring medical practitioner and in-formation on the clinical context has been provided, or it is part of an approved health screening program;
(b) The medical exposure has been justified by means of consultation between the radiologi-cal medical practitioner and the referring medical practitioner, as appropriate, or it is part of an approved health screening program;
(c) A radiological medical practitioner has assumed responsibility for overall protection and safety for the patient in the planning and delivery of the medical exposure specified by the relevant competent authority.
(d) The patient or the patient's legally authorized representative has been informed as ap-propriate of the expected diagnostic or therapeutic benefits of the radiological procedure as well as the radiation risks.
Section 71: Involvement of Medical Personnel in Medical Exposures
208. The authorized person shall ensure that:
(a) The radiological medical practitioner performing or overseeing the radiological procedure has assumed responsibility for ensuring overall protection and safety for patients in the planning and delivery of the medical exposure, including the justification of the radiologi-cal procedure as required in Section 68 and the optimization of protection and safety, in cooperation with the medical physicist and the medical radiation technologist as required in Section 72;
(b) Radiological medical practitioners, medical physicists, medical radiation technologists and other health professionals with specific duties in regard to protection and safety for pa-tients in a given radiological procedure are specialized in the appropriate area;
(c) For therapeutic radiological procedures, the requirements of this Regulation for calibra-tion, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in Articles 216, 219 (c), 224 and 225, are ful-filled by or under the supervision of a medical physicist;
(d) For diagnostic radiological procedures and image-guided interventional procedures, the requirements of this regulation for medical imaging, calibration, dosimetry and quality as-surance, including the acceptance and commissioning of medical radiological equipment, as specified in Articles 216, 219 (a) and (b), 220, 224 and 225 are fulfilled by or under the oversight of or with the documented advice of a medical physicist, whose degree of in-volvement is determined by the complexity of the radiological procedures and the associ-ated radiation risks.
209. For the proper performance of all medical exposures, the authorized person shall ensure the availability of sufficient medical personnel.
210. The authorized person shall ensure that the management system clearly defines the assignment of individual responsibilities with the medical exposure and that any delegation of responsibilities for the protection of the patient by an authorized person is appropriately documented.
Section 72: Optimization of Protection and Safety
211. In relation to all exposures to which this Regulation apply except radiotherapeutic exposures, the authorized person shall ensure that doses arising from the exposure are kept as low as reasona-bly practicable consistent with obtaining the required medical information, taking into account economic and societal factors.
212. The authorized person shall ensure that diagnostic reference levels, are appropriately used for the optimization of the medical exposures of patients in diagnostic radiological procedures and image-guided interventional procedures.
213. In relation to all radiotherapeutic exposures, the authorized person shall ensure that exposures of target volumes are individually planned, their delivery appropriately verified taking into ac-count that doses to non-target volumes and tissues is kept as low as reasonably practicable and consistent with the intended radiotherapeutic purpose of the exposure.
214. The authorized person shall ensure that the particular aspects of medical exposures are consid-ered in the optimization process for the following situation:
(a) Pediatric patients subject to medical exposure;
(b) Individuals subject to medical exposure as part of an approved health screening program;
(c) Volunteers subject to medical exposure as part of a program of biomedical research;
(d) Exposure arising from therapeutic radiological procedures, image-guided interventional procedures, computed tomography and other relatively high doses to the patient;
(e) Exposure of the embryo or fetus, in particular for radiological procedures in which the abdomen or pelvis of the pregnant female patient is exposed to the useful radiation beam or could otherwise receive a significant dose;
(f) Exposure of a breastfed infant as a result of a female patient having undergone a radio-logical procedure with radiopharmaceuticals.
Section 73: Procedures
215. The authorized person shall establish written procedures for every type of radiological procedure that ensures the safety of the patient. The procedures shall describe the methods and apparatus settings for the accomplishment of examinations and treatment for relevant categories of pa-tients.
Section 74: Calibration
216. The authorized person shall ensure in accordance with Articles 207 (c) and (d) that:
(a) All sources giving rise to medical exposure are calibrated in terms of appropriate quanti-ties using an accepted procedure.
(b) Calibrations are carried out at the time of commissioning a unit prior to clinical use, after any maintenance procedure that could affect the dosimetry and at intervals defined by the relative authority;
(c) The radiation therapy doses are calibrated by a standard dosimetry laboratory prior to clinical use;
(d) Calibration of all dosimeters used for dosimetry of patients and for the calibration of sources is traceable to a standard dosimetry laboratory.
217. In the case of radiotherapy procedures, the authorized person shall have a reference instrument for dose measurement. This reference instrument shall be calibrated every second year against the requirement as prescribed by the NRRC.
218. The authorized person shall ensure that, on the intervals defined by the NRRC, necessary ar-rangements are made for calibrating all devices that show a measure of radiation dose in X-ray diagnostics and nuclear medicine procedures.
Section 75: Patients Dosimetry
219. The authorized person shall ensure that dosimetry of patients is performed and documented by or under the supervision of a medical physicist, using calibrated dosimeters and accepted proto-cols, including dosimetry to determine the following:
(a) For diagnostic radiological procedures, typical doses to patients for common procedures;
(b) For image-guided interventional procedures, typical doses to patients;
(c) For therapeutic radiological procedures, absorbed doses to the planning target volume for each patient treated with external beam therapy and/or brachytherapy and absorbed doses to relevant tissues or organs as determined by the radiological medical practitioner;
(d) For therapeutic radiological procedures with unsealed sources, typical absorbed doses to patients.
Section 76: Use of Diagnostic Reference Levels
220. The authorized person shall ensure that:
(a) Local assessments based on the measurements required in Section 75, are made at ap-proved intervals for those radiological procedures for which diagnostic reference levels have been established.
(b) A review is conducted to determine whether the optimization of protection and safety for patients is adequate, or whether corrective action is required if, for a given radiological procedure:
(i) Typical doses or activities exceed the relevant diagnostic reference level; or
(ii) Typical doses or activities fall substantially below the relevant diagnostic refer-ence level and the exposures do not provide useful diagnostic information or do not yield the expected medical benefit to the patient.
Section 77: General Requirements for the Control of the Medical Radiological Equipment
221. In addition to ensuring that the responsibilities stated in Section 70 are discharged, the authorized person shall ensure that medical radiological equipment and software that could influence the delivery of medical radiological exposure are in compliance with national standards.
222. The authorized person shall establish and maintain organizational, procedural, and technical ar-rangements for ensuring that no medical radiological equipment and software are used unless they are incompliance with national standards
223. The authorized person shall establish and keep up-to-date an inventory of the medical radiologi-cal equipment for each medical radiological installation for approval by the NRRC.
Section 78: Quality Assurance for Medical Exposure
224. The authorized person, in applying the requirements of this regulation in respect of management systems, shall establish a comprehensive program of quality assurance for medical exposures with the active participation of medical physicists, radiological medical practitioners, medical ra-diation technologists and, for complex nuclear medicine facilities, radio pharmacists and radio-chemists, and in conjunction with other health professionals as appropriate.
225. The authorized person shall ensure that programs of quality assurance for medical exposure in-clude, as appropriate to the medical radiation facility:
(a) Measurements of the physical parameters of medical radiological equipment made by, or under the supervision of a medical physicist:
(i) At the time of acceptance and commissioning of the equipment prior to its clinical use on patients;
(ii) Periodically after that;
(iii) After any major maintenance procedure that could affect the protection and safe-ty of patients;
(iv) After any installation of new software or modification of existing software that could affect the protection and safety of patients.
(b) Implementation of corrective actions if measured values of the physical parameters men-tioned in (a) above are outside established tolerance limits.
(c) Verification of the appropriate physical and clinical factors used in radiological proce-dures.
(d) Maintaining records of relevant procedures and results.
(e) Periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment.
226. The authorized person shall ensure that regular and independent audits are made of the program of quality assurance for medical exposures, and that their frequency is in accordance with the re-quirements established by NRRC.
Section 79: Special Protection of Pregnant or Breast-feeding Female Patients
227. The authorized person shall ensure that understandable signs are placed in public places, waiting rooms for patients, cubicles and other appropriate places, and that other means of communica-tion are also used as appropriate, to request female patients who are to undergo a radiological procedure to notify the radiological personnel in the event that:
(a) She is or might be pregnant;
(b) She is breast-feeding and the scheduled radiological procedure includes the administra-tion of a radiopharmaceutical.
228. The authorized person shall ensure that there are procedures in place for ascertaining the preg-nancy status of a female patient of reproductive capacity before the performance of any radiolog-ical procedure that could result in a significant dose to the embryo or fetus, so that this infor-mation can be considered in the justification for the radiological procedure and in the optimiza-tion of protection and safety.
229. The authorized person shall ensure that there are arrangements in place for establishing that a female patient is not currently breast-feeding before the performance of any radiological proce-dure involving the administration of a radiopharmaceutical that could result in a significant dose to a breastfed infant, so that this information can be considered in the justification for the radio-logical procedure and in the optimization of protection and safety.
Section 80: Release of Patients After Radionuclide Therapy
230. The authorized person shall ensure that no patient who has undergone a therapeutic radiological procedure with a sealed source or an unsealed source is discharged from a medical radiation fa-cility until it has been established by the medical physicist and the facility's radiation safety officer that:
(a) The activity (A) of radionuclides in the patient is such that doses that could be received by members of the public and family members would comply with the requirements estab-lished by the NRRC; and
(b) The patient or the legal guardian of the patient is provided with:
(i) Written instructions for keeping doses to persons in contact with or in the vicinity of the patient as low as reasonably achievable and for avoiding the spread of con-tamination;
(ii) Information on the radiation risks.
Section 81: Medical Exposures as Part of a Research Program
231. The authorized person shall ensure that the research program involving medical exposures is conducted in accordance with the relevant national laws.
232. For a research program the authorized person shall ensure that:
(a) The radiological medical practitioner has assumed responsibility as specified in Section 71;
(b) The individuals concerned participate voluntarily;
(c) These individuals are informed about the risks of exposure;
(d) Dose constraints, are used in the optimization of protection and safety for persons sub-ject to exposure;
(e) In the case of patients who voluntarily accept to undergo an experimental medical prac-tice and who are expected to receive a diagnostic or therapeutic benefit from this prac-tice, the dose levels concerned shall be considered on an individual basis by the practi-tioner and/or referrer prior to the exposure taking place.
Section 82: Protection of Carers and Comforters
233. The authorized person shall ensure that no individual incurs a medical exposure as a carer or comforter unless he or she has received, and has indicated an understanding of, relevant infor-mation on radiation protection and information on the radiation risks prior to providing care and comfort to an individual undergoing a radiological procedure.
234. The authorized person shall ensure that relevant dose constraints specified in Section 8 are used in the optimization of protection and safety in any radiological procedure in which an individual acts as a carer or comforter.
Section 83: Prevention of Unintended and Accidental Medical Radiological Exposure
235. The authorized person, in accordance with the relevant requirements of Sections 13, 34 and 87, shall ensure that all practicable measures are taken to minimize the likelihood and magnitude of unintended or accidental medical exposures arising from flaws in design and operational failures of medical radiological equipment, from failures of and errors in software, or as a result of hu-man error.
Section 84: Investigation of Unintended and Accidental Medical Radiological Exposures
236. The authorized person shall promptly investigate any of the following unintended or accidental medical exposures:
(a) Any medical treatment delivered to the wrong individual or to the wrong tissue or organ of the patient or using the wrong radiopharmaceutical, or with an activity (A), a dose or dose fractionation differing substantially from (over or under) the values prescribed by the radiological medical practitioner, or that could lead to unduly severe secondary ef-fects;
(b) Any diagnostic radiological procedure or image-guided interventional procedure in which the wrong individual or the wrong tissue or organ of the patient is subject to exposure;
(c) Any exposure for diagnostic purposes that is substantially greater than was intended;
(d) Any exposure arising from an image-guided interventional procedure that is substantially greater than was intended;
(e) Any inadvertent exposure of the embryo or fetus in the course of performing a radiologi-cal procedure;
(f) Any failure of medical radiological equipment, failure of software or system failure, or ac-cident, error, mishap or other unusual occurrences with the potential for subjecting the patient to a medical exposure that is substantially different from what was intended.
237. The authorized person shall, with regard to any unintended or accidental medical exposures in-vestigated as required in Article 236:
(a) Calculate or estimate the doses received and the dose distribution within the patient;
(b) Indicate the corrective actions required to prevent the recurrence of such an unintended or accidental medical exposure;
(c) Implement all the corrective actions that are under their own responsibility;
(d) Produce and keep, as soon as possible after the investigation or as otherwise required by the NRRC, a written record that states the cause of the unintended or accidental medical exposure and includes the information specified in (a) to (c) above, as relevant, and any other information as requested by the NRRC;
(e) For significant unintended or accidental medical exposures or as otherwise required by the NRRC, submit the written record specified in (d) above, immediately to the NRRC;
(f) Ensure that the appropriate radiological medical practitioner informs the referring medi-cal practitioner and the patient or the patient's legally authorized representative of the unintended or accidental medical exposure.
238. The authorized person shall cooperate with the NRRC for the timely dissemination of information, relevant to radiation protection in medical exposure, regarding lessons learned from significant events.
Section 85: Radiological Reviews
239. The authorized person shall ensure that radiological reviews are performed periodically by the radiological medical practitioners at the medical radiation facility, in cooperation with the medical radiation technologists and the medical physicists.
240. The radiological review shall include an investigation and critical review of the current practical application of the radiation protection principles of justification and optimization for the radiolog-ical procedures that are performed in the medical radiation facility.
Section 86: Records
241. The authorized person shall maintain and make available the following personnel records for a duration of the period specified by the NRRC:
(a) Any delegation of responsibilities by the authorized person.
(b) Training of personnel in radiation protection.
242. The authorized person shall maintain and make available the following records of calibration, do-simetry and quality assurance for a duration of the period specified by the NRRC:
(a) Results of the calibrations and periodic checks of the relevant physical and clinical param-eters selected during treatment of patients;
(b) Dosimetry of patients, as required in Section 75;
(c) Local assessments and reviews made with regard to diagnostic reference levels, as re-quired in Section 76;
(d) The associate quality assurance program, as required in Section 78.
243. The authorized person shall maintain and make available the following records for medical expo-sure for a duration of the period specified by the NRRC:
(a) For diagnostic radiology, information necessary for retrospective assessment of doses, in-cluding the number of exposures and the duration of fluoroscopic radiological proce-dures;
(b) For image-guided interventional procedures, information necessary for retrospective as-sessment of doses, including the duration of the fluoroscopic component and the number of images acquired;
(c) For nuclear medicine, the types of radiopharmaceutical administered and their activity (A);
(d) For external beam radiation therapy or brachytherapy, a description of the planning tar-get volume, the absorbed dose to the center of the planning target volume, and the max-imum and minimum absorbed doses delivered absorbed doses to the planning target volume, and the absorbed doses to relevant tissues or organs as determined by the ra-diological medical practitioner; and also, for external beam radiation therapy, the dose fractionation and the overall treatment time;
(e) Exposure records for volunteers subject to medical exposure as part of a program of bi-omedical research;
(f) Reports on investigations of unintended and accidental medical exposures as required in Section 84.