Part 13

1. Part 13 IAEA Training Material on Radiation Protection in Nuclear Medicine Organization and Responsibilities

2. OBJECTIVE To become familiar with the radiation protection requirements in nuclear medicine including staffing, responsibilities and duties. Part 13. Organization and responsibilities

3. Content • Managerial requirements • Radiation Protection Committee • Radiation Protection Officer • Nuclear Medicine Staff • Manufacturers/Suppliers • Regulatory Authority Part 13. Organization and responsibilities

4. Organizational Structure Regulatory Authority Authorization and Inspection Licensee Overall responsibility for application of BSS Employer Overall responsibility for application of BSS and/or Nuclear Medicine Facility Part 13. Organization and responsibilities

5. Module 13.1: Managerial requirements Part 13Organization andResponsibilities IAEA Training Material on Radiation Protection in Nuclear Medicine

6. Responsibilities of a licensee • Licensees shall: • establish radiation safety objectives • develop, implement and document a radiation safety programme • ensure compliance with requirements set out in legislation and regulations Part 13. Organization and responsibilities

7. Responsibilities of a licensee The licensee may appoint other people to carry out actions and tasks related to these responsibilities, but they shall retain the responsibility for the actions and tasks themselves. Registrants and licensees shall specifically identify individuals responsible for ensuring compliance with the Standards. Part 13. Organization and responsibilities

8. Organization (Large Hospital) Hospital Manager (Licensee) Occupational health service Radiation protection committee QualityAssurance committee Radiation protection officer HeadNuclear Medicine Nuclear MedicineSpecialist Nuclear MedicineTechnician Nuclear Medicine Physicist Part 13. Organization and responsibilities

9. Organization (Small Hospital) Hospital Manager (Licensee) QualityAssurance committee Head of Department Radiation protection officer Occupational health service Radiation protection committee Nuclear MedicineSpecialist Nuclear MedicineTechnician Nuclear Medicine Physicist Part 13. Organization and responsibilities

10. Administrative manager • Appoint the necessary personnel and ensure the individuals have the necessary education to perform their duties. • Establish a radiation protection programme and provide the necessary resources. • Assign clear responsibilities for personnel. • Appoint a Radiation Protection Officer. • Establish a Radiation Protection Committee • Establish a comprehensive QA programme. • Support education and training of personnel. Part 13. Organization and responsibilities

11. Radiation Protection Program • Determine measures and resources required to meet objectives and ensure they are provided • Review measures and resources regularly • Identify failures and shortcomings and take steps to prevent them • Establish consultation and co-operation of all parties • Maintain records of activities Part 13. Organization and responsibilities

12. Typical elements of a RPP • Assignment of responsibilities • The Radiation Protection Officer • Designation of radiation areas • Local rules • Education and training • Planning for accidents and emergencies • Health surveillance and monitoring • Review and audit • System of recording and reporting Part 13. Organization and responsibilities

13. Documentation of RPP • The assignment of responsibilities for radiation protection and safety to individuals or to positions within the organization, including corresponding organizational arrangements and, if applicable (for example, in the case of itinerant workers), the allocation of the respective responsibilities between employers and the licensee; • The classification of controlled or supervised areas; • The local rules for workers to follow and the supervision of work; • The arrangements for monitoring workers and the workplace, including the acquisition and maintenance of radiation protection instruments; • The system for recording and reporting all the relevant information related to the control of exposures (occupational and public), safety of sources including waste management, the decisions regarding measures for radiation protection and safety, and the assessment of doses to occupationally exposed individuals. Part 13. Organization and responsibilities

14. Documentation of RPP • Specifically in relation to medical exposure, the system for calibration of sources, clinical dosimetry of patients and provision of quality assurance programmes. • The system for constraining the exposure of comforters, carers and volunteers. • The education and training programme on the nature of the hazards, protection and safety; • The methods for periodically reviewing and auditing the performance of the radiation protection programme; • The plans to be implemented in case of intervention ; • The health surveillance programme for workers; • The requirements for the assurance of quality and process improvement. Part 13. Organization and responsibilities

15. Local Rules • Local rules are intended to provide adequate levels of protection and safety through the establishment of common work procedures and other systems to be followed by all workers in the area • They should include all information required for work in the area, and be made known to all workers Part 13. Organization and responsibilities

16. Local Rules Set down in writing : person(s) responsible for supervising the work description of controlled and supervised areas general radiation safety measures dose investigation levels emergency plans Part 13. Organization and responsibilities

17. Radiation Safety Manual • The RSM is ideally a local reference book, and made available to (and possibly mandatory reading for) all radiation workers • An effective aid to training, and a valuable tool in itself is a Radiation Safety Manual • This now is required practice in many countries Radiation Safety Manual Part 13. Organization and responsibilities

18. Radiation Safety Manual • The RSM should include sections on : • basics of radiation safety • sources, risks and effects of radiation • local radiation safety organization • national/state regulations • personnel monitoring • emergency procedures Part 13. Organization and responsibilities

19. Module 13.2: Radiation Protection Committee Part 13Organization andResponsibilities IAEA Training Material on Radiation Protection in Nuclear Medicine

20. RADIATION PROTECTION COMMITTEE • review and oversee compliance with, and implementation of, the RPP; • formulate radiation protection policies to update and improve the RPP; • provide the RPO with guidance on operational aspects of the RPP, and request actions on specific matters; • investigate any radiation incidents or accidents and provide a comprehensive report on these to the employer; and • assess potential hazards from foreseeable incidents and prepare contingency plans. Part 13. Organization and responsibilities

21. RADIATION PROTECTION COMMITTEE The RPC shall recommend actions to the licensee to: • correct identified deficiencies in the RPP; • review new uses of radiation sources that may lead to modifications of the RPP; • identify any amendments to the licence; • identify staff needing personal authorization; and • periodically review the training programme. Part 13. Organization and responsibilities

22. RADIATION PROTECTION COMMITTEE RPC should be composed of clinical staff representing the hospital departments using radiation sources, medical physicists and persons who have special knowledge of the hazards of radiation and are experienced in radiation protection. Also included should be a representative of the hospital’s administrative unit, and a union or staff representative. The radiation protection officer, and possibly a physician from the occupational health service should also be members. The RPC should hold meetings at least every three months, and perform comprehensive internal audits annually, or when necessary, and report the outcome of its activities to the licensee/management. Part 13. Organization and responsibilities

23. Module 13.3 Radiation Protection Officer Part 13Organization andResponsibilities IAEA Training Material on Radiation Protection in Nuclear Medicine

24. RADIATION PROTECTION OFFICER (1/4) • providing a link between the RPC and the users of radiation within the institution; • supervising operational aspects of the RPP; • providing practical advice on implementation of local rules and procedures; • identifying deficiencies in compliance with the RPP and reporting to the licensee and the RPC; • identifying training needs and organizing training activities; • systematically verifying that tasks requiring personal authorization are only performed by staff with a valid authorization; • monitoring source security: receiving sources and maintaining the source inventory; • co-operating with officers of the Regulatory Authority and facilitating internal and external audits; Part 13. Organization and responsibilities

25. RADIATION PROTECTION OFFICER (2/4) • contributing to the planning and design of any new or modified radiation facility; • undertaking the radiation safety assessment of new installations, processes and equipment, prior to their acceptance; • identifying and establishing controlled and supervised areas; • specifying appropriate monitoring procedures; • ensuring that enough radiation monitoring instruments are available and that they are calibrated and serviced as required; • implementing a personal and workplace monitoring programme; • systematically and periodically reviewing monitoring programme in all areas where radiation sources are used, stored or disposed of; • analysing and interpreting radiation monitoring data; • informing all radiation users of their personal doses and ensuring that these are consistent with optimization; Part 13. Organization and responsibilities

26. RADIATION PROTECTION OFFICER (3/4) • ensuring that appropriate measures are taken to control the exposure of a pregnant employee; • assessing potential hazard from foreseeable incidents and drafting contingency plans; • exercising and carrying out emergency procedures; • being available for consultation on radiation protection matters; • ensuring that appropriate action is taken when an employee reports a matter which can compromise radiation protection; • ensuring that appropriate radiation protection training is provided on a regular basis as part of an ongoing "radiation protection awareness programme" for all users and for those who occasionally come into contact with radiation sources (i.e. cleaning staff, security, maintenance people); • ensuring that necessary leak testing of sealed sources is performed; Part 13. Organization and responsibilities

27. RADIATION PROTECTION OFFICER (4/4) • supervising decontamination procedures; • providing instruction to nursing staff on the correct procedures for handling and disposal of soiled linen and for dealing with spillage of urine from patients receiving bone pain palliation therapy; • providing waste disposal procedures in accordance with the conditions of the licence or as specified by the Regulatory Authority; • investigating all overexposures, accidents and losses of radiation sources and reporting to the RPC/Regulatory Authority as necessary; • maintaining required records; and • preparing a comprehensive annual report for the RPC and for forwarding to the Regulatory Authority if required. Part 13. Organization and responsibilities

28. Module 13.4 Nuclear Medicine Staff Part 13Organization andResponsibilities IAEA Training Material on Radiation Protection in Nuclear Medicine

29. Nuclear Medicine Specialist • ensuring overall radiation protection of the patient; • prescribing and justifying diagnosis and therapy in writing, taking into account relevant information from previous examinations; • ensuring that the exposure of patients is the minimum required to achieve the intended objective taking into account the relevant guidance levels for medical exposure; • providing consultation and clinical evaluation of patients; • establishing optimized protocols for diagnostic and therapeutic procedures, in consultation with the medical physicist; • evaluating any radiation incident or accident from a medical point of view; and • providing criteria to manage the examination of pregnant women, paediatric patients, medico-legal procedures, occupational health examinations and medical and biomedical research. Part 13. Organization and responsibilities

30. MEDICAL PHYSICIST -participating in the continuing review of the nuclear medicine practice’s resources (including budget, equipment, and staffing), operations, policies and procedures; -planning, in conjunction with the nuclear medicine physician and the RPO, the facilities for nuclear medicine practice; -preparing performance specifications for equipment with regard to radiation protection; -carrying out acceptance testing of equipment; -supervising equipment maintenance; -designing, implementing and supervising QA procedures; -performing dose calculations; -participating in the investigation and evaluation of incidents and accidents; and -contributing to the radiation protection training programme Part 13. Organization and responsibilities

31. Nuclear medicine technologist • Patient identification; • Patient information; • Information to accompanying persons and staff nursing a patient after a nuclear medicine examination or therapy; • Verifying that the female patient is non-pregnant; • Assure that a mother in lactation is given information about discontinuation of nursing; • Make the calculation of administered activity to a child according to the local rules; • Verify the administered radiopharmaceutical and its activity; • Perform regular quality control of activity meter and other relevant equipment; • Perform regular workplace monitoring; • Correct handling of the equipment and safety accessories; • Inform the RPO in the case of accident or incident; • Inform the Nuclear Medicine Physician in the case of misadministrations; • Participate in education and training of new personnel. Part 13. Organization and responsibilities

32. Nuclear medicine technologist The technologist may have the following additional responsibilities, which - alternatively - may be the responsibility of a radiochemist or radiopharmacist: • Elution of sterile pertechnetate from a 99Mo/99mTc generator; • Preparation of radiopharmaceuticals from lyophilized kits according to the manufacturer’s instructions; and • Performance of quality control procedures on the prepared radiopharmaceuticals. Part 13. Organization and responsibilities

33. Module 13.5 Manufacturers and Suppliers Part 13Organization andResponsibilities IAEA Training Material on Radiation Protection in Nuclear Medicine

34. Authorized services • Considering that, according to the BSS, the activities listed below also require authorization, regulatory authorities may require the licensee of a nuclear medicine practice to contract any of the following services only to enterprises authorized by the Regulatory Authority: • import, distribution, sale or transfer of radioactive sources • personal monitoring • installation, maintenance of nuclear medicine equipment • disposal of radioactive sources Part 13. Organization and responsibilities

35. Manufacturer/Supplier • Design facilities for likely conditions of use • Transport sources as per IAEA ST-1 • Approval test prototype devices • Provide certificate of conformity • Provide instructions for safe use and maintenance Part 13. Organization and responsibilities

36. Module 13.6 Regulatory Authority Part 13Organization andResponsibilities IAEA Training Material on Radiation Protection in Nuclear Medicine

37. Regulatory Authority Technical services: • Dosimetry services • Laboratory services • Calibration services • Waste management • Medical services • Training services • Expert assistance Part 13. Organization and responsibilities

38. REGULATORY AUTHORITY The Regulatory Authority should be an important national expertise in radiation protection. Part 13. Organization and responsibilities

39. Questions? Part 13. Organization and responsibilities

40. DISCUSSION In a department having a newly installed gamma camera, the collimator fell off and killed a patient. Who isresponsible? Part 13. Organization and responsibilities

41. DISCUSSION A private clinic is setting up a practice ofthyroid treatments (5 patients/week, max 1GBq I-131). How should they organize the radiation protection? Part 13. Organization and responsibilities

42. Where to Get MoreInformation • Further readings • IAEA, International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources Safety Series No.115, (1996) • WHO/IAEA/PAHO/EC. Manual on Radiation Protection in Hospital and General Practices. Volume 1, Basic Requirements (draft) • IAEA. Practice-specific Model Regulations on Radiation Safety in Nuclear Medicine (in preparation) • IAEA, Organization and Implementation of a National Regulatory Infrastructure Governing Protection against Ionizing Radiation and the Safety of Radiation Sources, IAEA-TECDOC-1067, Vienna (1999). Part 13. Organization and responsibilities