Part 5

1. Part 5 IAEA Training Material on Radiation Protection in Nuclear Medicine Occupational ExposureProtection of the Worker

2. Occupational ExposureDefinition All exposures of workers incurred in the course of their work, with the exception of exposures excluded from the Standards and exposures from practices or sources exempted by the Standards Part 5. Occupational Protection

3. Objective To become familiar with the BSS detailed requirement and the Safety Guide on occupational exposures for radiation protection of workers in nuclear medicine Part 5. Occupational Protection

4. Contents • Responsibilities and conditions of service • Classification of areas • Sources of exposure • Safe handling of sources • Monitoring • Emergency procedures • Local rules and supervision • Health surveillance • Records Part 5. Occupational Protection

5. IAEA SAFETY STANDARDSBSS: Interim Version 2011 Part 5. Occupational Protection

6. The System of Protection and Safety: BSS (2011) • These Standards are based on the following safety principles: • Responsibility for safety • Role of Government • Leadership and Management for safety • Justification of Facilities and Activities • Optimization of Protection • Limitation of Risks to Individuals • Protection of present and future generations • Prevention of Accidents • Emergency Preparedness and Response • Protective actions to reduce existing or • unregulated radiation risks Part 5. Occupational Protection

7. Part 5. Occupational Exposure Protection of the Worker IAEA Training Material on Radiation Protection in Nuclear Medicine Module 5.1. Responsibilities

8. Responsibility for Safety:BSS 1.8 (2011) • The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks. • Other parties also bear certain responsibilities. For instance, suppliers of radiation generators and radioactive sources have responsibilities in relation to the design and manufacture and operating instructions for their safe use. • Health professionals may be involved in the preparation for, and the conduct of, radiological procedures, and each type has specific responsibilities, as established in these Standards. Part 5. Occupational Protection

9. Role of Government: BSS 1.9 (2011) A properly established governmental, legal and regulatory framework for safety provides for the regulation of facilities and activities that give rise to radiation risks. There is a hierarchy of responsibilities within this framework, from governments to regulatory bodies to the organizations responsible for and the persons engaged in activities involving radiation exposure. The government is responsible for the adoption within its national legal system of such legislation, regulations, and standards and measures as may be necessary to fulfil all its national and international obligations effectively, and for the establishment of an independent regulatory body. In some cases, more than one governmental organization may have the functions of a regulatory body for activities within their jurisdictions relating to the control of radiation and radioactive material Part 5. Occupational Protection

10. Role of Government: BSS 1.10 (2011) Both the government and the regulatory body have important responsibilities in establishing the regulatory framework for protecting people and the environment from harmful effects of radiation, including establishing standards. These standards require the government to ensure that there is coordination of government departments and agencies that have responsibilities for protection and safety. Part 5. Occupational Protection

11. Role of Government: BSS 1.11 (2011) The government is also responsible for ensuring, as necessary, that provision is made for support services such as education and training, and technical services. If these services are not available within the State, other mechanisms to provide them may have to be considered. The regulatory body is responsible for carrying out its required regulatory functions, such as the establishment of requirements and guidelines, the authorization and inspection of facilities and activities, and the enforcement of legislative and regulatory provisions. Part 5. Occupational Protection

12. Responsibilities of the regulatory body to occupational exposureRequirement 19: BSS (2011) The government or regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized, and the regulatory body shall enforce compliance with dose limits for occupational exposure. Part 5. Occupational Protection

13. Responsibilities of the regulatory body to occupational exposureRequirement 19: BSS (2011) 3.69. The government or regulatory body shall establish the responsibilities of employers, registrants and licensees with regard to application of the requirements for occupational exposure in planned exposure situations. 3.70. The government or regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized for occupational exposure. 3.71. The government or regulatory body shall establish and the regulatory body shall enforce compliance with the dose limits specified in Schedule III for occupational exposure. Part 5. Occupational Protection

14. Responsibilities of the regulatory body to occupational exposureRequirement 19: BSS (2011) 3.72. Before authorization of a new or modified practice, the regulatory body shall require, as appropriate, and review supporting documents from the responsible parties that state: (a) design criteria and design features relating to the exposure and potential exposure of workers in all operational states and accident conditions; (b) design criteria and design features of the appropriate systems and programmes for monitoring of workers for occupational exposure in all operational states and accident conditions. Part 5. Occupational Protection

15. Requirements for monitoring and recording of occupational exposureRequirement 20: BSS (2011) The regulatory body shall establish and enforce requirements for the monitoring and recording of occupational exposures in planned exposure situations. Part 5. Occupational Protection

16. Requirements for monitoring and recording of occupational exposureRequirement 20: BSS (2011) • 3.73. The regulatory body shall be responsible, as appropriate, for: • a) Establishment and enforcement of requirements for the monitoring, recording and control of occupational exposures in planned exposure situations in accordance with the requirements of these Standards; • (b) Review of monitoring programmes of registrants and licensees, which shall be adequate to ensure that the requirements with regard to occupational exposure in planned exposure situations are met; • (c) Authorization or approval of service providers for individual monitoring and calibration services; Part 5. Occupational Protection

17. Requirements for monitoring and recording of occupational exposureRequirement 20: BSS (2011) • 3.73. The regulatory body shall be responsible, as appropriate, for: • (d) Review of periodic reports on occupational exposure (including results of monitoring programmes and dose assessments) submitted by employers, registrants and licensees; • (e) Provision for maintaining exposure records and results of the assessment of doses from occupational exposure; • (f) Verification of compliance of an authorized practice with the requirements on the control of occupational exposure Part 5. Occupational Protection

18. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) Employers, registrants and licensees shall be responsible for the protection of workers against occupational exposure. Employers, registrants and licensees shall ensure that protection and safety is optimized and that the dose limits for occupational exposure are not exceeded. Part 5. Occupational Protection

19. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) • 3.74. For workers who are engaged in activities in which they are or could be subject to occupational exposure in planned exposure situations, employers, registrants and licensees shall be responsible for: • (a) Protection of workers against occupational exposure; • (b) Compliance with other relevant requirements of these Standards. • 3.75. Employers who are also registrants or licensees shall have the responsibilities of both employers and registrants or licensees. Part 5. Occupational Protection

20. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) • 3.76. Employers, registrants and licensees shall ensure, for all workers engaged in activities in which they are or could be subject to occupational exposure, that: • (a) Occupational exposure is controlled so that the relevant dose limits for occupational exposure specified in Schedule III are not exceeded; • (b) Protection and safety is optimized in accordance with the requirements of these Standards; • (c) Decisions with regard to measures for protection and safety are recorded and made available to relevant parties, through their representatives where appropriate, as specified by the regulatory body; Part 5. Occupational Protection

21. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) contd.. (d) Policies, procedures and organizational arrangements for protection and safety are established for implementing the relevant requirements of these Standards, with priority given to design measures and technical measures for controlling occupational exposure; (e) Suitable and adequate facilities, equipment and services for protection and safety are provided, the type and extent of which are commensurate with the expected likelihood and magnitude of the occupational exposure; (f) Necessary health surveillance and health services for workers are provided; (g) Appropriate monitoring equipment and personal protective equipment are provided and arrangements are made for its proper use, calibration, testing and maintenance; (h) Part 5. Occupational Protection

22. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) contd… (h) Suitable and adequate human resources and appropriate training in protection and safety are provided, as well as periodic retraining as required to ensure the necessary level of competence; (i) Adequate records are maintained in accordance with the requirements of these Standards; (j) Arrangements are made to facilitate consultation of and cooperation with workers with regard to protection and safety, through their representatives where appropriate, on all measures necessary to achieve the effective application of these Standards; (k) Necessary conditions for promoting a safety culture are provided. Part 5. Occupational Protection

23. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) contd… • 3.77. Employers, registrants and licensees shall: • (a) Involve workers, through their representatives where appropriate, in optimization of protection and safety; • (b) Establish and use, as appropriate, constraints as part of optimization of protection and safety. • 3.78. Employers, registrants and licensees shall ensure that workers exposed to radiation from sources within a practice that are not required by or directly related to their work have the same level of protection against such exposure as members of the public. Part 5. Occupational Protection

24. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) contd… 3.79. Employers, registrants and licensees shall take such administrative actions as are necessary to ensure that workers are informed that ensuring protection and safety is an integral part of a general occupational health and safety programme in which they have specific obligations and responsibilities for their own protection and the protection of others against radiation exposure and for the safety of sources. Part 5. Occupational Protection

25. Responsibilities of employers, registrants and licensees for the protection of workersRequirement 21: BSS (2011) contd… 3.80. Employers, registrants and licensees shall record any report received from a worker that identifies circumstances that could affect compliance with the requirements of these Standards, and shall take appropriate action. 3.81. Nothing in these Standards shall be construed as relieving employers from complying with applicable national and local laws and regulations governing hazards in the workplace. 3.82. Employers, registrants and licensees shall facilitate compliance by workers with the requirements of these Standards. Part 5. Occupational Protection

26. Protection of the worker Part 5. Occupational Protection

27. Compliance by WorkersRequirement 22: BSS (2011) • Workers shall fulfil their obligations and carry out their duties for protection and safety. • 3.83. Workers: • (a) Shall follow any applicable rules and procedures for protection and safety as specified by the employer, registrant or licensee; • (b) Shall use properly the monitoring equipment and personal protective equipment provided; • (c) Shall cooperate with the employer, registrant or licensee with regard to protection and safety, and programmes for workers’ health surveillance and programmes for dose assessment; Part 5. Occupational Protection

28. Compliance by WorkersRequirement 22: BSS (2011) contd… • (d) Shall provide to the employer, registrant or licensee such information on their past and present work that is relevant for ensuring effective and comprehensive protection and safety for themselves and others; • (e) Shall abstain from any wilful action that could put themselves or others in situations that would not be in accordance with the requirements of these Standards; • (f) Shall accept such information, instruction and training in protection and safety as will enable them to conduct their work in accordance with the requirements of these Standards. Part 5. Occupational Protection

29. Compliance by WorkersRequirement 22: BSS (2011) contd… 3.84. A worker who identifies circumstances that could adversely affect protection and safety shall report such circumstances to the employer, registrant or licensee as soon as possible. Part 5. Occupational Protection

30. Workers Responsibilities • “Workers shall: • follow any applicable rules for protection • use properly the monitoring devices and the protective equipment and clothing provided • co-operate with the licensee with respect to protection” Part 5. Occupational Protection

31. Cooperation between employers and registrants and licenseesRequirement 23: BSS (2011) Employers and registrants and licensees shall cooperate to the extent necessary for compliance by all responsible parties with the requirements for protection and safety. 3.85. If workers are engaged in work that involves or that could involve a source that is not under the control of their employer, the registrant or licensee responsible for the source and the employer shall cooperate to the extent necessary for compliance by both parties with the requirements of these Standards. Part 5. Occupational Protection

32. Part 5. Occupational Exposure Protection of the Worker IAEA Training Material on Radiation Protection in Nuclear Medicine Module 5.2. Classification of Areas

33. CLASSIFICATION OF AREAS • Controlled area • Supervised area Part 5. Occupational Protection

34. Requirement 24: BSS (2011)Arrangements under the radiation protection programme: Employers, registrants and licensees shall establish and maintain organizational, procedural and technical arrangements for the designation of controlled areas and supervised areas, for local rules and for monitoring of the workplace, in a radiation protection programme for occupational exposure. Part 5. Occupational Protection

35. Classification of Areas:Controlled Area “3.88. Registrants and licensees shall designate as a controlled area any area in which specific measures for protection and safety are or could be required for: (a) controlling exposures or preventing the spread of contamination in normal operation; (b) preventing or limiting the likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions. 3.89. In determining the boundaries of any controlled area, registrants and licensees shall take account of the magnitudes of the exposures expected in normal operation, the likelihood and magnitude of exposures in anticipated operational occurrences and in accident conditions, and the type and extent of the procedures required for protection and safety.” Part 5. Occupational Protection

36. Controlled Area • “3.90. Registrants and licensees: • (a) Shall delineate controlled areas by physical means or, where this is not reasonably practicable, by some other suitable means; • (b) Shall, where a source is only intermittently brought into operation or energized, or is moved from place to place, delineate an appropriate controlled area by means that are appropriate under the prevailing circumstances and shall specify exposure times; • (c) Shall display the symbol recommended by the International Organization for Standardization (ISO) and shall display instructions at access points to and at appropriate locations within controlled areas; • (d) Shall establish measures for protection and safety, including, as appropriate, physical measures to control the spread of contamination and local rules and procedures for controlled areas; • (e) Shall restrict access to controlled areas by means of administrative procedures such as the use of work permits, and by physical barriers, which could include locks or interlocks, the degree of restriction being commensurate with the likelihood and magnitude of exposures;” Part 5. Occupational Protection

37. Controlled Area • (f) Shall provide, as appropriate, at entrances to controlled areas: • (i) Personal protective equipment; • (ii) Equipment for individual monitoring and workplace monitoring; • (iii) Suitable storage for personal clothing; • (g) Shall provide, as appropriate, at exits from controlled areas: • (i) Equipment for monitoring for contamination of skin and clothing; • (ii) Equipment for monitoring for contamination of any objects or material being removed from the area; • (iii) Washing or showering facilities and other personal decontamination facilities; • (iv) Suitable storage for contaminated personal protective equipment; • (h) Shall periodically review conditions to assess whether there is any need to modify the measures for protection and safety or the boundaries of controlled areas; • (i) Shall provide appropriate information, instruction and training for persons working in controlled areas.” Part 5. Occupational Protection

38. Classification of Areas:Supervised Area • “3.91. Registrants and licensees shall designate as a supervised area any area not already designated as a controlled area but for which occupational exposure conditions need to be kept under review, even though specific measures for protection and safety are not normally needed. • 3.92. Registrants and licensees, taking into account the nature, likelihood and magnitude of exposures or contamination in the supervised areas: • (a) Shall delineate the supervised areas by appropriate means; • (b) Shall display approved signs, as appropriate, at access points to supervised areas; • (c) Shall periodically review conditions to assess whether there is any need for further measures for protection and safety or any need for changes to the boundaries of supervised areas.” Part 5. Occupational Protection

39. Classified Areas Should be defined by the RPO and RPC Controlled areas: • Room for preparation of radiopharmaceuticals • Room for dispensing radiopharmaceuticals • Room for storage of radionuclides • Room for storage of radioactive waste • Room for administration of radiopharmaceuticals • Imaging rooms, if or when administration is done Supervised areas: • The whole department Part 5. Occupational Protection

40. …...appropriate instructions at access points Part 5. Occupational Protection

41. …..display a warning symbol Part 5. Occupational Protection

42. WORK IN CONTROLLED AREA 1 Access to controlled areas must be limited to essential staff, patients and other personnel as may be authorized by the Head of Department. Anyone entering a controlled area must follow these rules. 2 All staff who regularly work in controlled areas will be issued a personal dosimeter which must be worn whenever they enter a controlled area. 3 The occasional entry to a controlled area of any other person not wearing a dosimeter (e.g. patients' relatives or escorts) may be permitted provided that they remain under the supervision of an authorized member of staff. 4 Other people who need to enter a controlled area on an occasional basis at times when they are not under the supervision of an authorized member of staff (e.g. works staff or contractors working outside normal hours) must be issued with a 'Permit to enter a controlled area'. 5 Outside normal working hours controlled areas must be locked to prevent unauthorized access. Part 5. Occupational Protection

43. WORK IN CONTROLLED AREA • 6 To avoid skin contamination and/or accidental ingestion of radionuclides: • laboratory coats or other suitable clothing should be worn to prevent accidental contamination of normal clothes; • b) disposable plastic gloves should be worn when working with any unsealed source (e.g. preparing radiopharmaceuticals, drawing up a dose or giving an injection); • c) laboratory coats should be removed and hands washed before eating or drinking and before going home; • d) disposable paper handkerchiefs should be used; • e) skin cuts and abrasions should be covered before working with unsealed sources; • f) if there is any risk of splashing, eyes should be protected (e.g. behind the transparent door of the laminar flow cabinet); • g) mouth pipettes must never be used. Always use a bulb pipette or a syringe for measuring radioactive solutions; Part 5. Occupational Protection

44. WORK IN CONTROLLED AREA • h) no one should eat, drink, smoke or apply cosmetics in controlled areas with the following exceptions- • i) eating and drinking by a patient as part of a diagnostic procedure, • ii) in the nursing station patients and escort staff may eat provided that no administration of radioactive substances is being carried out at the time and any contamination from previous administrations has been dealt with by a suitably qualified member of staff, • iii) in the waiting room patients, escorts and accompanying persons may normally eat and drink; there should be no radioactive contamination hazard because the area must not be used for administration of radioactive substances. • However, if contamination has occurred (e.g. if a patient vomits or leaks urine or other body fluid after the radiopharmaceutical has been administered) then the area must be considered to be 'Controlled' under the regulations relating to internal hazard and no-one may eat or drink until it has been decontaminated and/or monitored and pronounced safe by a suitably trained member of staff. Part 5. Occupational Protection

45. WORK IN CONTROLLED AREA • 7 To avoid spread of contamination: • a) activity must not be splashed around (e.g. do not squirt syringes to expel the air); • b) as far as is practicable all operations involving unsealed sources should be carried out over a drip tray; • c) syringes containing radioactive solutions should be placed, with their shielding, in a tray before being transported; • d) any bench top which is used for the manipulation of unsealed sources (e.g. blood samples) should be covered with absorbent paper which should be replaced if contamination occurs; and • e) while wearing gloves which may be contaminated, unnecessary contact with all other objects should be avoided. Gloves should be removed and disposed of in the radioactive waste bin as soon as work with radioactive substances is finished. Part 5. Occupational Protection

46. WORK IN CONTROLLED AREA • 8 To minimize the hazard from external radiation: • a) sources must be kept within suitable lead shielding when not in use. Vials of activity should only be removed from their lead pots when this is absolutely necessary (e.g. to place in the ionization chamber); • b) unshielded vials of activity should only be manipulated with long handled tongs; • c) syringes containing radioactivity should be fitted with lead syringe shields whenever possible; • d) patient doses should be kept in the shielded storage area until required. Unused doses should be returned to the radionuclide laboratory at the end of each session; and • e) personnel should keep as far away as possible from all sources and organize work so as to minimize the time spent in close proximity to large sources, (e.g. stand back while the 99mTc generator is eluting). Part 5. Occupational Protection

47. Part 5. Occupational Exposure Protection of the Worker IAEA Training Material on Radiation Protection in Nuclear Medicine Module 5.3. Sources of Exposure

48. EXPOSURES IN NUCLEAR MEDICINE Internal Ingested and/or inhaled radionuclides External Vials, syringes, patients. Part 5. Occupational Protection

49. Optimization of Protection Risk Dose Unacceptable Limit for workers Source related constraints Tolerable Optimized working procedures Acceptable Occupational exposure Part 5. Occupational Protection

50. Exposure of the Worker Unpacking radioactive material Activity measurements Storage of sources Internal transports of sources Preparation of radiopharmaceuticals Administration Examination of the patient Care of the radioactive patient Handling of radioactive waste Accidents Part 5. Occupational Protection