1. IAEA International Atomic Energy Agency PREVENTION OF ACCIDENTAL EXPOSURE IN RADIOTHERAPY Part 1: Review of International Basic Safety Standards (BSS) IAEA Training Course

2. IAEA International Atomic Energy Agency Module 1.2: BSS Section 3: Planned Exposure Situations – Medical Exposure IAEA Training Course

3. IAEA 3 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

4. IAEA 4 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

5. IAEA 5 Requirement 34 Responsibilities of the government: The government shall ensure that relevant parties are authorized to assume their roles and responsibilities, and that diagnostic reference levels, dose constraints, and criteria and guidelines for the release of patients are established. With a consultation between the health authority, relevant professional bodies and the regulatory body. Prevention of accidental exposure in radiotherapy

6. IAEA 6 Requirement 34 - DRL Responsibilities of the government: The government shall ensure a set of diagnostic reference levels(DRL) is established for medical exposures incurred in medical imaging. In setting such diagnostic reference levels, account shall be taken of the need for adequate image quality. (3.148) Diagnostic Reference Levels: A value of dose, dose rate or activity that indicates a level above which there should be a review in order to determine whether or not the value is excessive. Prevention of accidental exposure in radiotherapy

7. IAEA 7 Requirement 34 - DRL The Diagnostic Reference Levels are intended: a) to be a reasonable indication of doses for average sized patients b) to be established by relevant professional bodies in consultation with the Regulatory Authority c) to provide guidance on what is achievable with current good practice rather than on what should be considered optimum performance d) to be applied with flexibility to allow higher exposures if these are indicated by sound clinical judgement e) to be revised as technology and techniques improve Prevention of accidental exposure in radiotherapy

8. IAEA 8 Requirement 34 - DRL Prevention of accidental exposure in radiotherapy http://www.arpansa.gov.au/services/ndrl/ndrlfactsheet.cfm

9. IAEA 9 Responsibilities of the government: The government shall ensure that dose constraints are established to be fulfilled for: (3.149 – a) 1)exposure of carers and comforters, 2)exposures due to diagnostic investigations of volunteers participating in a programme of biomedical research. For medical exposures, dose constraints should only be applied to the above two categories, not to diagnostic or therapeutic exposures. Requirement 34 – Dose Constraints Prevention of accidental exposure in radiotherapy

10. IAEA 10 Carers and Comforters Relevant in the case of a paediatric patient, or a relative or friend for a disabled or very elderly or very ill patients They must be informed about the radiation risks involved in helping with the radiological procedure and about the means to be taken to afford appropriate radiation protection Requirement 34 – Dose Constraints Prevention of accidental exposure in radiotherapy

11. IAEA 11 Volunteers Justified only if it is in accordance with the provisions of the Helsinki Declaration takes into account the guidelines published by the Council for International Organizations of Medical Sciences, together with the recommendations of the ICRP Requirement 34 – Dose Constraints Prevention of accidental exposure in radiotherapy Subject to approval by an ethics committee (or other institutional body with similar functions)

12. IAEA 12 Requirement 34 – Release of the patients Responsibilities of the government: The government shall ensure that criteria and guidelines for the release of patients who have undergone therapeutic radiological procedures using unsealed sources or patients who still remain implanted sealed sources are established. (3.149 - b) Prevention of accidental exposure in radiotherapy

13. IAEA 13 Requirement 35 Responsibilities of the regulatory body The regulatory body shall require that health professionals with responsibilities for medical exposures are specialized in the appropriate area and that they fulfil the requirements for education, training and competence in the relevant specialty. Prevention of accidental exposure in radiotherapy

14. IAEA 14 Requirement 36 Responsibilities of the registrants and licensees Registrants and licensees shall ensure that no person incurs a medical exposure unless there has been an appropriate referral, responsibility has been assumed for ensuring protection and safety, and the person subject to exposure has been informed as appropriate of the expected benefits and risks. The registrants and licensees should take overarching responsibility for each individual. Prevention of accidental exposure in radiotherapy

15. IAEA 15 Responsibilities of the registrants and licensees For therapeutic radiological procedures, the requirements of these Standards for calibration, dosimetry and quality assurance are fulfilled by or under the supervision of a medical physicist. (3.154 – d) Requirement 36 – specific to radiotherapy Prevention of accidental exposure in radiotherapy

16. IAEA 16 Radiotherapy is multidisciplinary in nature - a variety of professionals are involved. This includes professional groups such as medical physicists, radiotherapy technicians, dosimetrists and engineers specialized in radiotherapy equipment as well as oncology and patient support staff such as oncology nurses, dieticians, social workers and other allied health professionals. In regard to all physical aspects of the radiation delivery the medical physicist carries the ultimate responsibility. Requirement 36 – specific to radiotherapy Prevention of accidental exposure in radiotherapy

17. IAEA 17 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

18. IAEA 18 Justification of medical exposure: Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits that they are expected to yield against the radiation detriment that they might cause. (3.155) Generic justification of a radiological procedure shall be carried out by the health authority in conjunction with appropriate professional bodies, and shall be reviewed from time to time, with account taken from advances in knowledge and technological developments. (3.156) Requirement 37 Prevention of accidental exposure in radiotherapy

19. IAEA 19 The justification of medical exposure shall be carried out, taking account of: (3.157) a) The appropriateness of the request; b) The urgency of the radiological procedure; c) The characteristics of the medical exposure; d) The characteristics of the individual patient; e) Relevant information from the patient’s previous radiological procedures. National or international referral guidelines shall be taken into account. (3.158) Particular attention to be taken for patients who are pregnant or breast-feeding or paediatric patients. Requirement 37 - Justification Prevention of accidental exposure in radiotherapy

20. IAEA 20 Requirement 37 - Justification Level 1 Deals with use of radiation in medicine in general In practice, its justification is taken for granted. Level 2 Deals with specified procedures with a specified objective To judge whether the procedure will improve diagnosis or provide necessary information about those exposed Level 3 Deals with the application of the procedure to an individual The particular application should be judged to do more good than harm for the individual patient. Prevention of accidental exposure in radiotherapy

21. IAEA 21 Clinical context, medical history Defensive medicine Knowledge about procedure – benefits, risks, limitations Financial conflict of interest Referral guidelines / criteria of appropriateness..shall be carried out through consultation between the radiological medical practitioner and the referring medical practitioner, …. Referring physicians Radiological practitioner “Request for consultation” versus “order/instruction to perform” Requirement 37 - Justification Prevention of accidental exposure in radiotherapy

22. IAEA 22 Requirement 37 - Justification Justification of medical exposure: Introducing and applying 3A’s approach: Tools that are likely to facilitate and enhance justification in practice Awareness Awareness Appropriateness Appropriateness Audit Audit Prevention of accidental exposure in radiotherapy

23. IAEA Radiation Protection of Patients RPOP http://rpop.iaea.org Radiation Protection of Patients RPOP http://rpop.iaea.org 3A’s - Awareness 3A’s - Awareness Worldwide need of promoting awareness Devising means for effective communication about radiation risks and hence the actual need for justification Requirement 37 - Justification Prevention of accidental exposure in radiotherapy

24. IAEA 3A’s - Appropriateness 3A’s - Appropriateness Ensuring that those referred for radiological examinations really need the examinations Joint responsibility Development and use of referral guidelines or appropriateness criteria (clinical imaging guidelines) Software for referral International collaboration in developing guidelines -Shared review of the literature -Uniform methodology -Exploring joint approaches to improve their use International collaboration in developing guidelines -Shared review of the literature -Uniform methodology -Exploring joint approaches to improve their use IAEA Smart Card/SmartRadTrack project - Developing methodologies to track radiation history IAEA Smart Card/SmartRadTrack project - Developing methodologies to track radiation history Requirement 37 - Justification Availability of relevant information from the patient’s previous radiological procedures Prevention of accidental exposure in radiotherapy

25. IAEA 3A’s – Audit 3A’s – Audit Reviewing and checking the effectiveness of the referral and related processes Regular and independent audits Requirement 37 - Justification Critical review of the current practical application of justification(& optimization) for the radiological procedures being performed in the facility. Prevention of accidental exposure in radiotherapy

26. IAEA 26 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

27. IAEA 27 Requirement 38 Optimization of protection and safety Registrants and licensees and radiological medical practitioners shall ensure that protection and safety is optimized for each medical exposure. 1. Design considerations 2. Operational consideration 3. Calibration 4. Dosimetry of patients 5. Diagnostic reference levels 6. Quality assurance for medical exposures 7. Dose constraints Prevention of accidental exposure in radiotherapy

28. IAEA 28 Optimization 1 – Design Considerations Registrants and licensees shall ensure that medical radiological equipment and software that could influence the delivery of medical exposure are used only if they conform to the applicable standards of the International Electrotechnical Commission and the International Organization for Standardization or to national standards adopted by regulatory body. (3.162) Prevention of accidental exposure in radiotherapy

29. IAEA 29 Optimization 1 – Design Considerations The International Electrotechnical Commission (IEC), through its Technical Committee 62 on Electrical equipment in medical practice and in particular, Sub-committee 62C on Equipment for radiotherapy, nuclear medicine and radiation dosimetry The International Organization for Standardization (ISO), through its Technical Committee 85 on Nuclear energy, nuclear technologies, and radiological protection and in particular, Sub-committee 2 on Radiological protection Prevention of accidental exposure in radiotherapy

30. IAEA 30 Purchase specifications that include conditions to meet relevant international standards of the IEC and ISO and/or equivalent national standards. There should be awareness in developing countries that they have the power to require compliance by suppliers and to make use of acceptance tests, which are universally shared by manufacturers Optimization 1 – Design Considerations Prevention of accidental exposure in radiotherapy

31. IAEA 31 Optimization 2 – Operation For therapeutic radiological procedures, the radiological medical practitioner shall ensure that exposure of volumes other than the planning target volume is kept as low as reasonably achievable consistent with delivery of the prescribed dose to the planning target volume within the required tolerances. (3.164) In procedures where radiopharmaceuticals are administered, the appropriate radiopharmaceutical with the appropriate activity shall be selected and administered, so that the radioactivity is primarily localized in the organ(s) of interest. (3.165) Prevention of accidental exposure in radiotherapy

32. IAEA 32 Particular aspects of medical exposures are considered in the optimization process for: (3.166) Paediatric patients subject to medical exposure; … Relatively high doses to the patient; Exposure of the embryo or fetus; Exposure of a breastfed infant as a result of a female patient having undergone a radiological procedure with radiopharmaceuticals. Optimization 2 – Operation Prevention of accidental exposure in radiotherapy

33. IAEA 33 Medical physicist shall ensure that: (3.167) a) All sources of medical exposure are calibrated in terms of appropriate quantities using accepted protocols; b) Calibrations are carried out at the time of commissioning a unit prior to clinical use, after any maintenance procedure and at intervals approved by the regulatory body; c) Calibrations of radiation therapy units are subject to independent verification prior to clinical use; Optimization 3 – Calibration Prevention of accidental exposure in radiotherapy

34. IAEA 34 Optimization 3 – Calibration d) Calibration of all dosimeters is traceable to a standards dosimetry laboratory. Calibration of radiotherapy units are subjected to independent verification prior to clinical use in conformance with a protocol (such as IAEA TRS-381 and TRS-398) Prevention of accidental exposure in radiotherapy

35. IAEA 35 Optimization 4 – Dosimetry of patients Registrants and licensees shall ensure that dosimetry of patients is performed and documented by or under the supervision of a medical physicist, using calibrated dosimeters and following accepted protocols, including dosimetry to determine the following (3.168) … (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. Prevention of accidental exposure in radiotherapy

36. IAEA 36 Registrants and licensees shall ensure that: (3.169) a) Local assessments are made at approved intervals for those radiological procedures for which DRLs 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 DRL; or ii. Typical doses or activities fall substantially below the relevant DRL and the exposures do not yield the expected medical benefit to the patient. Optimization 5 – DRL Prevention of accidental exposure in radiotherapy

37. IAEA Registrants and licensees shall establish a comprehensive programme of QA for medical exposures (3.170) With the active participation of Medical physicists Radiological medical practitioners Medical radiation technologists Taking into account principles established by: WHO PAHO Professional bodies Optimization 6 - Quality Assurance Prevention of accidental exposure in radiotherapy 37

38. IAEA 38 Registrants and licensees shall ensure that programmes of QA for medical exposure include: (3.171) (a) Measurements of physical parameters of medical radiological equipment made by, or under the supervision of, a medical physicist; (b) Implementation of corrective actions if measured values of the physical parameters are outside established tolerance limits; Optimization 6 - Quality Assurance Prevention of accidental exposure in radiotherapy

39. IAEA 39 Registrants and licensees shall ensure that programmes of QA for medical exposure include: (3.171) (c) Verification of the appropriate physical and clinical factors used in radiological procedures; (d) Maintaining records of relevant procedures and results; (e) Periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment. Optimization 6 - Quality Assurance Prevention of accidental exposure in radiotherapy

40. IAEA 40 Registrants and licensees shall ensure that relevant dose constraints are used in the optimization of protection and safety in any radiological procedure in which an individual acts as a carer or comforter. (3.173) Registrants and licensees shall ensure that dose constraints specified or approved by the ethics committee on a case by case basis as part of a proposal for biomedical research are used in the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research. (3.174) Optimization 7 – Dose Constraints Prevention of accidental exposure in radiotherapy

41. IAEA 41 Optimization – ALARA As Low As Reasonably Achievable Achieving the treatment or therapeutic objectives with the lowest possible dose. Whichever diagnostic method or treatment is chosen, it should always be performed with the lowest possible radiation dose for both the patient and the medical personnel. ALARA should be consistent with economic and social factors which need to be taken into account. Prevention of accidental exposure in radiotherapy

42. IAEA 42 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

43. IAEA 43 Requirement 39 Registrants and licensees shall ensure that there are arrangements in place for appropriate radiation protection in cases where a female patient is or might be pregnant or is breast- feeding. Prevention of accidental exposure in radiotherapy

44. IAEA Registrants and licensees shall ensure that signs in appropriate languages are placed in public places, and that other means of communication are also used as appropriate to request female patients to notify the patient’s pregnancy or breast-feeding status. (3.175) Requirement 39 Prevention of accidental exposure in radiotherapy 44

45. IAEA 45 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

46. IAEA 46 Requirement 40 Registrants and licensees shall ensure that there are arrangements in place to ensure appropriate radiation protection for members of the public and for family members before a patient is released following radionuclide therapy. Prevention of accidental exposure in radiotherapy

47. IAEA 47 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

48. IAEA 48 Requirement 41 Registrants and licensees shall ensure that all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures. Registrants and licensees shall promptly investigate unintended or accidental medical exposures and, if appropriate, shall implement corrective actions. Prevention of accidental exposure in radiotherapy

49. IAEA Preventative measures Registrants and licensees shall ensure that all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures arising from: (3.179) Flaws in design; Operational failures of medical radiological equipment; Failures of and errors in software; Human error. Requirement 41 Prevention of accidental exposure in radiotherapy 49

50. IAEA Issues of preventive measures The licensee being made aware of events Actions to minimize further recurrence Promoting a culture of learning from mistakes Voluntary reporting systems Reporting of events to the regulatory body Dissemination of information Requirement 41 Prevention of accidental exposure in radiotherapy 50

51. IAEA Investigation of unintended and accidental medical exposures Registrants and licensees shall promptly investigate: Any medical treatment: Delivered to the wrong individual or to the wrong tissue; With a dose differing substantially from that the prescribed; That could lead to unduly severe secondary effects Any inadvertent exposure of the embryo or foetus Any failure of the medical radiological equipment, software failure or system failure, or accident, error, mishap with the potential for subjecting the patient to a medical exposure that is substantially different from what was intended. (3.180) Requirement 41 Prevention of accidental exposure in radiotherapy 51

52. IAEA Registrants and licensees shall, with regard to any unintended or accidental exposures investigated: (3. 181) Requirement 41 a)Calculate or estimate the doses received and the dose distribution within the patient; b)Indicate the corrective actions to prevent recurrence; c)Implement all the corrective actions; d)Produce and keep a written record of the investigation; for significant accidental medical exposures, submit the record to the regulatory body; e)Ensure that the radiological medical practitioner informs the referring medical practitioner and the patient of the incident. Prevention of accidental exposure in radiotherapy 52

53. IAEA 53 BSS Section 3 – Medical Exposure BSS Section 3 – Medical Exposure addresses: 1. Responsibilities of government, regulatory body, registrants and licensees specific to medical exposure 2. Justification of medical exposures 3. Optimization of protection and safety 4. Pregnant or breast-feeding female patients 5. Release of patients after radionuclide therapy 6. Unintended and accidental medical exposures 7. Reviews and records Prevention of accidental exposure in radiotherapy

54. IAEA 54 Requirement 42 Registrants and licensees shall ensure that radiological reviews are performed periodically at medical radiation facilities and that records are maintained. Prevention of accidental exposure in radiotherapy

55. IAEA Registrants and licensees shall ensure that radiological reviews: (3.182) Be performed periodically by the radiological medical practitioners at the medical radiation facility; Include an investigation and critical review of the current practical application of the radiation protection principles of justification and optimization. Requirement 42 – Radiological reviews Prevention of accidental exposure in radiotherapy 55

56. IAEA Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make the following available: Requirement 42 - Records Personnel records a)Delegation of responsibilities b)Training of personnel in radiation protection (3.183) Records of calibration, dosimetry and quality assurance (3.184) 56 Prevention of accidental exposure in radiotherapy

57. IAEA 57 Registrants and licensees shall maintain the records for medical exposure for external beam radiation therapy or brachytherapy: (3.185 - d) Requirement 42 - Records a description of the planning target volume the absorbed dose to the centre of the planning target volume the maximum and minimum absorbed doses delivered to the planning target volume, or equivalent alternative information on absorbed doses to the planning target volume the absorbed doses to relevant tissues or organs as determined by the radiological medical practitioner for external beam radiation therapy, the dose fractionation and the overall treatment time. Prevention of accidental exposure in radiotherapy

58. IAEA 58 Summary Looked at Basic Safety Standards Section 3: Planned Exposure Situations Focusing on Medical Exposure (Requirements 34 – 42) Move on to group activity, G1: “BSS” Prevention of accidental exposure in radiotherapy

59. IAEA Reference Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (GSR part 3), IAEA Australian Radiation Protection and Nuclear Safety Agency – National Diagnostic Reference Level http://www.arpansa.gov.au/services/ndrl/ndrlfactsheet.cfm