1.Part 3Part 3 Principles of radiation protection andPrinciples of radiation protection and the international frameworkthe international framework Regulatory requirementsRegulatory requirements IAEA Training Material on Radiation Protection in Nuclear Medicine

2. Part 3. Principles of Radiation Protection2Nuclear Medicine OBJECTIVEOBJECTIVE To become aware of the ICRPsTo become aware of the ICRPs conceptualconceptual framework and theframework and the InternationalInternational Basic SafetyBasic Safety Standards requirement (BSS) and relatedStandards requirement (BSS) and related Safety Guides in radiation protection inSafety Guides in radiation protection in medical field.medical field. 3. Part 3. Principles of Radiation Protection3Nuclear Medicine ContentContent Principles of radiation protectionPrinciples of radiation protection International Basic Safety StandardsInternational Basic Safety Standards Regulatory controlRegulatory control 4. Part 3.Part 3. Module 3.1. Basic principles of radiationModule 3.1. Basic principles of radiation protectionprotection IAEA Training Material on Radiation Protection in Nuclear Medicine 5. Part 3. Principles of Radiation Protection5Nuclear Medicine Do we need radiation protectionDo we need radiation protection in nuclear medicine?in nuclear medicine? 6. Part 3. Principles of Radiation Protection6Nuclear Medicine What can radiation do? Death Cancer Skin Burns Cataract Infertility Genetic effects 7. Part 3. Principles of Radiation Protection7Nuclear Medicine What can radiation do? Deterministic effects death, skin burns, cataract, infertility Stochastic effects cancer, genetic effects 8. Part 3. Principles of Radiation Protection8Nuclear Medicine Deterministic effects cataract infertility erythema epilation Cancer Genetic Prob dose 500 mSv cataract 150 mSv for sterility (temporary-males) 2500 mSv for ovarian Stochastic effects DOSE EFFECT 9. Part 3. Principles of Radiation Protection9Nuclear Medicine OBJECTIVES OF RADIATIONOBJECTIVES OF RADIATION PROTECTIONPROTECTION PREVENTIONPREVENTION of deterministicof deterministic effecteffect LIMITINGLIMITING the probability ofthe probability of stochastic effectstochastic effect 10. Part 3. Principles of Radiation Protection10Nuclear Medicine The need for protectionThe need for protection applies to all dose levelsapplies to all dose levels It is generally assumed that even veryIt is generally assumed that even very small doses of ionizing radiation cansmall doses of ionizing radiation can potentially be harmful (linear nopotentially be harmful (linear no threshold hypothesis)threshold hypothesis) Therefore, persons must be protectedTherefore, persons must be protected from ionizing radiation at all dose levelsfrom ionizing radiation at all dose levels 11. Part 3. Principles of Radiation Protection11Nuclear Medicine Who should be protected inWho should be protected in nuclear medicine?nuclear medicine? PatientPatient Members of his/her familyMembers of his/her family WorkerWorker General publicGeneral public 12. Part 3. Principles of Radiation Protection12Nuclear Medicine How should the people beHow should the people be protected?protected? Optimize protectionOptimize protection Justify the exposureJustify the exposure Dose limitationsDose limitations 13. Part 3. Principles of Radiation Protection13Nuclear Medicine This is the system ofThis is the system of radiological protection asradiological protection as defined by the ICRPdefined by the ICRP (International Commission on(International Commission on Radiological Protection)Radiological Protection) 14. Part 3. Principles of Radiation Protection14Nuclear Medicine What is the ICRP?What is the ICRP? A non-governmentalA non-governmental professional organizationprofessional organization established in 1928 by theestablished in 1928 by the International Congress ofInternational Congress of RadiologyRadiology 15. Part 3. Principles of Radiation Protection15Nuclear Medicine A group of recognized leaders in the field ofA group of recognized leaders in the field of radiation protectionradiation protection concerned with the protection of humans fromconcerned with the protection of humans from ionizing radiationionizing radiation official relationships with WHO, IAEA, ICRUofficial relationships with WHO, IAEA, ICRU convenes task groups of experts to addressconvenes task groups of experts to address particular issuesparticular issues issues reports and recommendationsissues reports and recommendations What is the ICRP?What is the ICRP? 16. Part 3. Principles of Radiation Protection16Nuclear Medicine Ionizing Radiation We live with 1-3 mSv/y Can kill 4000 mSv Is there a safe point? If not, how to deal with the problem? 17. Part 3. Principles of Radiation Protection17Nuclear Medicine To protect the people taking into account the main objectives of radiation protection the system of protection should be based on: A. Individual-related system dose limit (absolute maximum risk that society can accept), optimization B. Source-related system limitation on source, source related constraints basic protection + environmental + individual protection (by shielding, protective clothing...) 18. Part 3. Principles of Radiation Protection18Nuclear Medicine 19. Part 3. Principles of Radiation Protection19Nuclear Medicine The ICRP RecommendationsThe ICRP Recommendations ICRP publication 60 - 1990ICRP publication 60 - 1990 The recommended system of radiationThe recommended system of radiation protection is based upon 3 principles:protection is based upon 3 principles: Benefit of a practice must offset the radiationBenefit of a practice must offset the radiation detriment (justification)detriment (justification) Exposures and likelihood of exposure shouldExposures and likelihood of exposure should be kept as low as reasonably achievable,be kept as low as reasonably achievable, economic and social factors being taken intoeconomic and social factors being taken into account (optimization)account (optimization) Dose limits should be set to ensure that noDose limits should be set to ensure that no individual faces an unacceptable risk in normalindividual faces an unacceptable risk in normal circumstancescircumstances 20. Part 3. Principles of Radiation Protection20Nuclear Medicine ICRP 60ICRP 60 Weighs all existing data to arrive atWeighs all existing data to arrive at quantitative recommendations for risk,quantitative recommendations for risk, detriment, dose and dose ratedetriment, dose and dose rate weighting factorsweighting factors Considers exposure to humans onlyConsiders exposure to humans only Considers exposure in threeConsiders exposure in three categories: occupational, medical,categories: occupational, medical, publicpublic 21. Part 3. Principles of Radiation Protection21Nuclear Medicine IAEA BSS (1996) - glossaryIAEA BSS (1996) - glossary Occupational exposureOccupational exposure All exposures of workers incurred inAll exposures of workers incurred in the course of their work, with thethe course of their work, with the exception of exposures excludedexception of exposures excluded from the Standards and exposuresfrom the Standards and exposures from practices or sources exemptedfrom practices or sources exempted by the Standards. by the Standards. 22. Part 3. Principles of Radiation Protection22Nuclear Medicine IAEA BSS (1996) - glossaryIAEA BSS (1996) - glossary Medical exposureMedical exposure Exposure incurred by patients as part ofExposure incurred by patients as part of their own medical or dental diagnosis ortheir own medical or dental diagnosis or treatment; by persons, other than thosetreatment; by persons, other than those occupationally exposed, knowingly whileoccupationally exposed, knowingly while voluntarily helping in the support andvoluntarily helping in the support and comfort of patients; and by volunteers in acomfort of patients; and by volunteers in a programme of biomedical researchprogramme of biomedical research involving their exposure.involving their exposure. 23. Part 3. Principles of Radiation Protection23Nuclear Medicine IAEA BSS (1996) - glossaryIAEA BSS (1996) - glossary Public exposurePublic exposure Exposure incurred by members of theExposure incurred by members of the public from radiation sources, excludingpublic from radiation sources, excluding any occupational or medical exposure andany occupational or medical exposure and the normal local natural backgroundthe normal local natural background radiation but including exposure fromradiation but including exposure from authorized sources and practices and fromauthorized sources and practices and from intervention situations. intervention situations. 24. Part 3. Principles of Radiation Protection24Nuclear Medicine JustificationJustification No use of ionizing radiation is justified ifNo use of ionizing radiation is justified if there is no benefitthere is no benefit All applications must be justifiedAll applications must be justified This implies: All, even the smallestThis implies: All, even the smallest exposures are potentially harmful andexposures are potentially harmful and the risk must be offset by a benefitthe risk must be offset by a benefit 25. Part 3. Principles of Radiation Protection25Nuclear Medicine Risk/Benefit analysisRisk/Benefit analysis Need to evaluate the benefits ofNeed to evaluate the benefits of radiation - an easy task in the case ofradiation - an easy task in the case of nuclear medicinenuclear medicine Radiation is the diagnostic andRadiation is the diagnostic and therapeutic agenttherapeutic agent Assessment of the risks requires theAssessment of the risks requires the knowledge of the dose received byknowledge of the dose received by personspersons 26. Part 3. Principles of Radiation Protection26Nuclear Medicine OptimizationOptimization When radiation is to be used then theWhen radiation is to be used then the exposure should be optimized toexposure should be optimized to minimize any possibility of detriment.minimize any possibility of detriment. Optimization is doing the best you canOptimization is doing the best you can under the prevailing conditionsunder the prevailing conditions Need to be familiar with techniques andNeed to be familiar with techniques and options to optimize the application ofoptions to optimize the application of ionizing radiation - this is really the mainionizing radiation - this is really the main objective of the present courseobjective of the present course 27. Part 3. Principles of Radiation Protection27Nuclear Medicine OptimizationOptimization Must take into account the resourcesMust take into account the resources available - this includes economicavailable - this includes economic circumstancescircumstances Often a tricky question - where shall weOften a tricky question - where shall we stop, how much shielding should westop, how much shielding should we really use?really use? Governed by the optimization principleGoverned by the optimization principle 28. Part 3. Principles of Radiation Protection28Nuclear Medicine Optimization principleOptimization principle As Low As Reasonably Achievable This means radiation exposure should be limited as much as possible keeping in mind the risk-benefit relation of radiation and its applications. For example, it is unreasonable to refuse an X-ray after a bone fracture because statistically this may shorten your life expectancy by one day. The benefits of the X- ray with its diagnostic value by far outweigh the risk associated with the radiation exposure. 29. Part 3. Principles of Radiation Protection29Nuclear Medicine very much in line with thevery much in line with the rest of real liferest of real life Both justification and optimization areBoth justification and optimization are part of all strategies when handlingpart of all strategies when handling potentially harmful substances orpotentially harmful substances or dealing with risks:dealing with risks: there must be a benefitthere must be a benefit the risk should be kept as low as possiblethe risk should be kept as low as possible Same for household chemicals, drugs,Same for household chemicals, drugs, traffic, travel, sports, .traffic, travel, sports, . 30. Part 3. Principles of Radiation Protection30Nuclear Medicine A comment on theA comment on the optimization principle (as lowoptimization principle (as low as reasonably achievable)as reasonably achievable) Issues which are often subject ofIssues which are often subject of discussion:discussion: L what is a low dose?L what is a low dose? R what is reasonable?R what is reasonable? 31. Part 3. Principles of Radiation Protection31Nuclear Medicine What is low?What is low? It can be very costly toIt can be very costly to consider every doseconsider every dose level explicitlylevel explicitly Discussions are on-Discussions are on- going about dose levelsgoing about dose levels below regulatorybelow regulatory concernconcern A potential starting pointA potential starting point are doses from naturalare doses from natural background which arebackground which are inevitable and one caninevitable and one can assume organismsassume organisms have adapted to themhave adapted to them 32. Part 3. Principles of Radiation Protection33Nuclear Medicine Average annual doses in mSv from natural sources in European countries 33. Part 3. Principles of Radiation Protection34Nuclear Medicine What is Radon (What is Radon (222222 Rn) ?Rn) ? It is a radioactiveIt is a radioactive gas that existsgas that exists everywhere in theeverywhere in the atmosphereatmosphere It is a member ofIt is a member of thethe 238238 U seriesU series It is formed by theIt is formed by the decay ofdecay of 226226 RaRa 34. Part 3. Principles of Radiation Protection35Nuclear Medicine What is Radon (What is Radon (222222 Rn) ?Rn) ? Half-life 3.82 daysHalf-life 3.82 days It is an alpha emitter decaying toIt is an alpha emitter decaying to 218218 PoPo 218218 Po is also an alpha emitter (T 3 min)Po is also an alpha emitter (T 3 min) Other important decay products areOther important decay products are 214214 Po (Po (, T 0.164 msec) and, T 0.164 msec) and 214214 Bi (Bi (,, T 19.9 min)T 19.9 min) 35. Part 3. Principles of Radiation Protection36Nuclear Medicine Why is Radon a Problem?Why is Radon a Problem? The hazard arises from the inhalationThe hazard arises from the inhalation of its decay products which are notof its decay products which are not gaseousgaseous Most of the decay products becomeMost of the decay products become attached to aerosols in theattached to aerosols in the atmosphere and are deposited in theatmosphere and are deposited in the conducting airways and in the lungconducting airways and in the lung during respiration.during respiration. 36. Part 3. Principles of Radiation Protection37Nuclear Medicine Other important contributions toOther important contributions to natural exposure: Potassium-40natural exposure: Potassium-40 4040 K constitutes 120 parts per million of stableK constitutes 120 parts per million of stable potassium which is an essential tracepotassium which is an essential trace element in every human bodyelement in every human body 4040 K has a halflife of 1.28 x 10K has a halflife of 1.28 x 1099 years, decayingyears, decaying by beta emission (Eby beta emission (Emaxmax 1.3 MeV)1.3 MeV) An 80 kg adult male contains about 180 g ofAn 80 kg adult male contains about 180 g of potassium -> 18 mg ofpotassium -> 18 mg of 4040 KK This gives an annual internal effective doseThis gives an annual internal effective dose of 170 Svof 170 Sv 37. Part 3. Principles of Radiation Protection38Nuclear Medicine The cosmic ray contribution to the background radiation varies markedly with altitude. Note, that at cruising altitude in a Boeing 747 the dose rate is approximately 5 Sv/h 38. Part 3. Principles of Radiation Protection39Nuclear Medicine Example of Radiation ExposureExample of Radiation Exposure to Aircrew to Cosmic Radiationto Aircrew to Cosmic Radiation Exposure of New Zealand aircrewExposure of New Zealand aircrew International RoutesInternational Routes 1000 hours per year, with 90% of the time at an altitude of1000 hours per year, with 90% of the time at an altitude of 12 km12 km 6.5 mSv annual dose from cosmic radiation6.5 mSv annual dose from cosmic radiation Domestic RoutesDomestic Routes 1000 hours per year, with 70% of the time at an altitude of1000 hours per year, with 70% of the time at an altitude of 11 km11 km 3.5 mSv annual dose from cosmic radiation3.5 mSv annual dose from cosmic radiation Adapted from L Collins 2000 39. Part 3. Principles of Radiation Protection40Nuclear Medicine Average Background DosesAverage Background Doses UNSCEAR 2000 ReportUNSCEAR 2000 Report WORLDWIDE AVERAGE DOSESWORLDWIDE AVERAGE DOSES Source Effective dose Typical rangeSource Effective dose Typical range (mSv per year) (mSv per year)(mSv per year) (mSv per year) External exposureExternal exposure Cosmic raysCosmic rays 0.40.4 0.3-1.00.3-1.0 Terrestrial gamma rays 0.5Terrestrial gamma rays 0.5 0.3-0.60.3-0.6 Internal exposureInternal exposure InhalationInhalation 1.21.2 0.2-100.2-10 IngestionIngestion 0.30.3 0.2-0.80.2-0.8 TotalTotal 2.42.4 110110 40. Part 3. Principles of Radiation Protection41Nuclear Medicine What is reasonable?What is reasonable? Depends on prevailing conditionsDepends on prevailing conditions includingincluding economiceconomic culturalcultural Should be based on a risk/benefitShould be based on a risk/benefit analysis of the practiceanalysis of the practice 41. Part 3. Principles of Radiation Protection42Nuclear Medicine Dose limitationDose limitation No dose limitation for medical exposureNo dose limitation for medical exposure of the patient - it is always assumedof the patient - it is always assumed that the benefits for the patientthat the benefits for the patient outweigh the risksoutweigh the risks Limits need to be applied for public andLimits need to be applied for public and occupational exposures.occupational exposures. 42. Part 3. Principles of Radiation Protection43Nuclear Medicine Limits and constraintsLimits and constraints Dose limits are one of the three principles ofDose limits are one of the three principles of protection as introduced by ICRP and BSS.protection as introduced by ICRP and BSS. Fixed dose limits are recommended by ICRPFixed dose limits are recommended by ICRP and often enforced by a national legal processand often enforced by a national legal process (Radiation Protection Legislation).(Radiation Protection Legislation). Dose constraints are used in an optimizationDose constraints are used in an optimization process to guide planning. Constraints andprocess to guide planning. Constraints and the importance thereof may be subject tothe importance thereof may be subject to change to achieve the optimum solution to achange to achieve the optimum solution to a problem (Best practice guidelines).problem (Best practice guidelines). 43. Part 3. Principles of Radiation Protection44Nuclear Medicine Optimization and doseOptimization and dose limitationlimitation It is NOT the aim to get close to the limitIt is NOT the aim to get close to the limit values - the aim is to get as low asvalues - the aim is to get as low as reasonably achievablereasonably achievable Is part of risk managementIs part of risk management Keeps the risks of dealing with ionizingKeeps the risks of dealing with ionizing radiation of the same order as otherradiation of the same order as other risksrisks 44. Part 3.Part 3. Module 3.2. International Basic SafetyModule 3.2. International Basic Safety StandardsStandards IAEA Training Material on Radiation Protection in Nuclear Medicine 45. Part 3. Principles of Radiation Protection46Nuclear Medicine IAEA was established in 1957 and has the following functions: Safeguards (verification of peaceful uses) Technology (fostering the transfer of) Safety 46. Part 3. Principles of Radiation Protection47Nuclear Medicine IAEA RADIATION SAFETY FUNCTIONS Article III.A.6 of its Statute To establish standards of radiation safety To provide for the application of these standards To service international conventions 47. Part 3. Principles of Radiation Protection48Nuclear Medicine BASIC SAFETYBASIC SAFETY STANDARDSSTANDARDS The purpose of the Standards is to establish basic requirements for protection against the risk associated with exposure to ionizing radiation and for the safety of radiation sources that may deliver such exposure. The Standards lay down basic principles and indicate the different aspects that should be covered by an effective radiation protection programme The Standards are aimed to serve as a practical guide for public authorities and services, employers and workers, specialized radiation protection bodies, enterprises and safety and health committees. 48. Part 3. Principles of Radiation Protection49Nuclear Medicine First Basic Safety Standards 1962 Revised Basic Safety Standards 1967 Revised and Joint with FAO, ILO, OECD/NEA, WHO 1982 ICRP published revised recommendations 1991 Consultants, Senior experts meetings, ad hoc working groups, technical committees 1991, 1992, 1993 6th draft circulated to all member states March 1994 7th Draft approved by IAEA Board of Governors Sept 1994 Publication of Interim Version S.S.115I 1994 Formal approval by co-sponsoring organizations 1994-1996 Publication of S.S.115 1996 HISTORYHISTORY 49. Part 3. Principles of Radiation Protection50Nuclear Medicine Jointly sponsored by:Jointly sponsored by: THE FOOD AND AGRICULTURE ORGANIZATION OF THETHE FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONSUNITED NATIONS (FAO)(FAO) THE INTERNATIONAL ATOMIC ENERGY AGENCYTHE INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA)(IAEA) THE INTERNATIONAL LABOUR ORGANIZATIONTHE INTERNATIONAL LABOUR ORGANIZATION (ILO)(ILO) THE NUCLEAR ENERGY AGENCY OF THE OECDTHE NUCLEAR ENERGY AGENCY OF THE OECD (NEA)(NEA) THE PAN AMERICAN HEALTH ORGANIZATIONTHE PAN AMERICAN HEALTH ORGANIZATION (PAHO)(PAHO) ANDAND THE WORLD HEALTH ORGANIZATIONTHE WORLD HEALTH ORGANIZATION (WHO)(WHO) 50. Part 3. Principles of Radiation Protection51Nuclear Medicine The IAEAs international standards are basedThe IAEAs international standards are based onon estimates on radiation health effects made by theestimates on radiation health effects made by the UnitedUnited Nations Scientific Committee on the Effects of AtomicNations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR)Radiation (UNSCEAR) andand radiation protection recommendations ofradiation protection recommendations of the International Commission on Radiological Protectionthe International Commission on Radiological Protection (ICRP)(ICRP) 51. Part 3. Principles of Radiation Protection52Nuclear Medicine THE SCIENTIFIC BASIS OF THE STANDARDSTHE SCIENTIFIC BASIS OF THE STANDARDS ICRP IAEAUNSCEAR Non-governmental Governmental Principles Recommendations Effects Standards 52. Part 3. Principles of Radiation Protection53Nuclear Medicine The United Nations Scientific Committee on theThe United Nations Scientific Committee on the Effects of Atomic RadiationEffects of Atomic Radiation UNSCEAR THE INTERNATIONAL GOVERNMENTALTHE INTERNATIONAL GOVERNMENTAL CONSENSUS ON THE HEALTH EFFECTS OFCONSENSUS ON THE HEALTH EFFECTS OF RADIATIONRADIATION 53. Part 3. Principles of Radiation Protection54Nuclear Medicine UNSCEARUNSCEAR is a committee of the UNis a committee of the UN General Assembly. It wasGeneral Assembly. It was established in 1955established in 1955.. What is UNSCEAR?What is UNSCEAR? 54. Part 3. Principles of Radiation Protection55Nuclear Medicine HOW UNSCEAR WORKSHOW UNSCEAR WORKS MOLECULAR BIOLOGY RADIOEPIDEMIOLOGY RADIOBIOLOGY JUDGMENT ON PLAUSIBILITY AND ESTIMATES 55. Part 3. Principles of Radiation Protection56Nuclear Medicine provides estimates of the healthprovides estimates of the health effects of exposure to ionizingeffects of exposure to ionizing radiationradiation Such asSuch as UNSCEARUNSCEAR 56. Part 3. Principles of Radiation Protection57Nuclear Medicine UNSCEAR has recently (2000) further assessed the cancer risk from radiation exposures. For a population of all ages and both genders, the life- time risk of dying from radiation induced cancer after an acute dose of 1000 mSv is about 9% for men and 13% for women or 11% as a mean. Applying a DDREF of 2, these data confirm the 10 years old ICRP estimate. Life-time risk of dying from radiation induced cancer = 5% per sievert 57. Part 3. Principles of Radiation Protection58Nuclear Medicine The International Commission ofThe International Commission of Radiological ProtectionRadiological Protection (ICRP) makes(ICRP) makes recommendations relating to radiationrecommendations relating to radiation protectionprotection ICRPICRP 58. Part 3. Principles of Radiation Protection59Nuclear Medicine Recommendations of the ICRPRecommendations of the ICRP Prepared typically by a task groupPrepared typically by a task group which includes other expertswhich includes other experts Approved by the full commissionApproved by the full commission Published in the journal Annals of thePublished in the journal Annals of the ICRPICRP Have no legal status themselves -Have no legal status themselves - however, are typically the foundationhowever, are typically the foundation onto which national legislation is builtonto which national legislation is built 59. Part 3. Principles of Radiation Protection60Nuclear Medicine Finally, on theFinally, on the basis ofbasis of UNSCEARUNSCEAR estimates andestimates and ICRPICRP recommendations,recommendations, the IAEAthe IAEA establishesestablishes internationalinternational standards onstandards on radiation andradiation and nuclear safetynuclear safety 60. Part 3. Principles of Radiation Protection61Nuclear Medicine Hierarchy of IAEA documentsHierarchy of IAEA documents Safety Fundamentals Safety Standards Approved by IAEA Board of Governors 61. Part 3. Principles of Radiation Protection62Nuclear Medicine Hierarchy of IAEA documentsHierarchy of IAEA documents Safety Guides Safety Practices TECDOCs Technical Reports Proceedings Safety Fundamentals and Standards Supported by 62. Part 3. Principles of Radiation Protection63Nuclear Medicine 63. Part 3. Principles of Radiation Protection64Nuclear Medicine PREAMBLE: Principles and Fundamental Objectives PRINCIPLE REQUIREMENTS: General-responsibilities and organizational Practices Interventions APPENDICES: DETAILED REQUIREMENTS Occupational exposure Medical exposure Public exposure Potential exposure: safety of sources Emergency exposure situations Chronic exposure situations SCHEDULES: Numerical LAYOUT OF BSSLAYOUT OF BSS 64. Part 3. Principles of Radiation Protection65Nuclear Medicine Radiation effects Practices and Interventions Types of Radiation Exposure Basic Principles Quantities and Units Governmental Regulation National Infrastructure The Regulatory Authority 65. Part 3. Principles of Radiation Protection66Nuclear Medicine BASIC PRINCIPLESBASIC PRINCIPLES The principles of radiation protection and safety on which the Standards are based are those developed by the ICRP (International Commission on Radiological Protection) and by INSAG (International Nuclear Safety Advisory Group). The practice must be justified Protection and safety should be optimized Individual doses from all relevant practices should not exceed specified dose limits 66. Part 3. Principles of Radiation Protection67Nuclear Medicine Specifies who are the responsibleSpecifies who are the responsible organisations and individuals,organisations and individuals, including the Regulatory Authority.including the Regulatory Authority. Defines the administrativeDefines the administrative requirements, including licensingrequirements, including licensing and registration.and registration. Uses the dose limitation systemUses the dose limitation system introduced in ICRP report 60..introduced in ICRP report 60.. 67. Part 3. Principles of Radiation Protection68Nuclear Medicine These Standards specify the basic requirements for protection of people against exposure to ionizing radiation and for the safety of radiation sources, hereafter termed protection and safety. PURPOSE (1.2) 68. Part 3. Principles of Radiation Protection69Nuclear Medicine The Standards apply to practices, including any sources within the practices, and interventions which are: (a) carried out in a State that adopts the Standards (b) undertaken by States with assistance of FAO, IAEA, ILO, PAHO or WHO (c) carried out by IAEA or with materials etc. from IAEA (d) where parties to bi/multi-lateral arrangements request application of the Standards SCOPE (1.3)SCOPE (1.3) 69. Part 3. Principles of Radiation Protection70Nuclear Medicine PRACTICEPRACTICE Any human activity that introduces additional sources of exposure or exposure pathways or extends exposure to additional people or modifies the network of exposure pathways from existing sources, so as to increase the likelihood of exposure of people or the number of people exposed. 70. Part 3. Principles of Radiation Protection71Nuclear Medicine Very broad definition (a) production of sources and use of radiation and radioactive substances for medical, industrial, veterinary, agricultural, education, training and research purposes (b) nuclear fuel cycle (c) exposure to natural sources specified by Regulatory Authority as requiring control (d) anything else specified by Regulatory Authority. PRACTICES Nuclear medicine is a practice 71. Part 3. Principles of Radiation Protection72Nuclear Medicine PRACTICEPRACTICE Existing Annual Dose expected additional annual dose attributable to the source Post-existing annual dose TimeIntroduction, operation and decommissioning of a practice Pre- existing annual dose CONTROL 72. Part 3. Principles of Radiation Protection73Nuclear Medicine INTERVENTIONINTERVENTION Any action intended to reduce or avert exposure or the likelihood of exposure to sources which are not part of a controlled practice or which are out of control as a consequence of an accident Intervention levels - refer to avertable dose. Action levels - above which protective or remedial actions taken. 73. Part 3. Principles of Radiation Protection74Nuclear Medicine emergency exposure situations requiring protective actions chronic exposure situations requiring remedial actions SITUATIONS REQUIRING INTERVENTION 74. Part 3. Principles of Radiation Protection75Nuclear Medicine Protective actionProtective action An intervention intended to avoid or reduce doses to members of the public in chronic or emergency exposure situations. 75. Part 3. Principles of Radiation Protection76Nuclear Medicine Remedial actionRemedial action Action taken when a specified action level is exceeded, to reduce radiation doses that might otherwise be received, in an intervention situation involving chronic exposure. 76. Part 3. Principles of Radiation Protection77Nuclear Medicine The dose to be saved by a protective action; that is, the difference between the dose to be expected with the protective action and that to be expected without it. Avertable dose 77. Part 3. Principles of Radiation Protection78Nuclear Medicine Pre-intervention existing annual dose Existing annual dose Averted annual dose by the intervention Time Post-intervention existing annual dose Intervention INTERVENTIONINTERVENTION CONTROL 78. Part 3. Principles of Radiation Protection79Nuclear Medicine Any exposure whose magnitude or likelihood is essentially unamenable to control, e.g. 40 K in the body, cosmic radiation at earths surface and unmodified concentrations of radionuclides in most raw materials. EXCLUSIONS(1.4)EXCLUSIONS(1.4) 79. Part 3. Principles of Radiation Protection80Nuclear Medicine Low individual radiation risk Low collective radiation detriment Inherently safe situation EXEMPTION CRITERIA 80. Part 3. Principles of Radiation Protection81Nuclear Medicine Practice or source may be exempted if - effective dose < 10Sv in a year - collective effective dose committed by one year of practice < 1manSv or - exemption is the optimum option EXEMPTIONEXEMPTION 81. Part 3. Principles of Radiation Protection82Nuclear Medicine Unless excluded or exempted ( the StandardsUnless excluded or exempted ( the Standards apply - including requirements forapply - including requirements for notificationnotification registrationregistration licensinglicensing Each application for authorization requires a safetyEach application for authorization requires a safety assessment.assessment. Each release of items from authorized premisesEach release of items from authorized premises requires clearance.requires clearance. GENERAL OBLIGATIONSGENERAL OBLIGATIONS authorizationauthorization 82. Part 3. Principles of Radiation Protection83Nuclear Medicine GENERAL OBLIGATIONSGENERAL OBLIGATIONS A) Allocation of responsibilityA) Allocation of responsibility B) Administrative requirementsB) Administrative requirements C) Radiation protection requirementsC) Radiation protection requirements D) Management requirementsD) Management requirements E) Technical requirementsE) Technical requirements F) Verification of SafetyF) Verification of Safety 83. Part 3. Principles of Radiation Protection84Nuclear Medicine Main responsibilities: registrants and licensees employers Subsidiary include: suppliers workers health professionals qualified experts A) Allocation of responsibilitiesA) Allocation of responsibilities 84. Part 3. Principles of Radiation Protection85Nuclear Medicine A) Allocation of responsibilitiesA) Allocation of responsibilities BSS 2.15. Registrants and licensees shall bear theBSS 2.15. Registrants and licensees shall bear the responsibility for setting up and implementing theresponsibility for setting up and implementing the technical and organizational measures that aretechnical and organizational measures that are needed for ensuring protection and safety for theneeded for ensuring protection and safety for the sources for which they are authorized. They maysources for which they are authorized. They may appoint other people to carry out actions and tasksappoint other people to carry out actions and tasks related to these responsibilities, but they shall retainrelated to these responsibilities, but they shall retain the responsibility for the actions and tasksthe responsibility for the actions and tasks themselves. Registrants and licensees shallthemselves. Registrants and licensees shall specifically identify the individuals responsible forspecifically identify the individuals responsible for ensuring compliance with the Standards.ensuring compliance with the Standards. 85. Part 3. Principles of Radiation Protection86Nuclear Medicine A) Allocation of responsibilitiesA) Allocation of responsibilities Emergency SituationsEmergency Situations Occupational ExposureOccupational Exposure Medical ExposureMedical Exposure Public ExposurePublic Exposure Safety of SourcesSafety of Sources 86. Part 3. Principles of Radiation Protection87Nuclear Medicine B) Administrative requirementsB) Administrative requirements NotificationNotification Authorization (Registration/Licensing)Authorization (Registration/Licensing) 87. Part 3. Principles of Radiation Protection88Nuclear Medicine NotificationNotification BSS 2.10. Any legal person intending toBSS 2.10. Any legal person intending to carry out any of the actions specified undercarry out any of the actions specified under the General Obligations for practices of thethe General Obligations for practices of the Standards (see paras 2.7 and 2.8) shallStandards (see paras 2.7 and 2.8) shall submit a notification to the Regulatorysubmit a notification to the Regulatory Authority of such an intention [6]. NotificationAuthority of such an intention [6]. Notification for consumer products is required only withfor consumer products is required only with respect to manufacturing, assembling,respect to manufacturing, assembling, importing and distributing.importing and distributing. 88. Part 3. Principles of Radiation Protection89Nuclear Medicine Authorization:Authorization: registration orregistration or licensinglicensing BSS 2.11.: The Legal person responsible forBSS 2.11.: The Legal person responsible for any sealed source, unsealed source orany sealed source, unsealed source or radiation generator shall, unless the sourceradiation generator shall, unless the source is exempted, apply to the Regulatoryis exempted, apply to the Regulatory Authority for an authorization which shall takeAuthority for an authorization which shall take the form of either a registration or a licence.the form of either a registration or a licence. This applies to a nuclear medicine department 89. Part 3. Principles of Radiation Protection90Nuclear Medicine Authorization: registration or licensingAuthorization: registration or licensing BSS 2.14.: The legal person responsible for a source toBSS 2.14.: The legal person responsible for a source to be used forbe used for medical exposuremedical exposure shall include in theshall include in the application for authorization:application for authorization: (a)(a) the qualifications in radiation protection of thethe qualifications in radiation protection of the medical practitioners who are to be so designated bymedical practitioners who are to be so designated by name in the registration or licence; orname in the registration or licence; or (b)(b) a statement that only medical practitioners with thea statement that only medical practitioners with the qualifications in radiation protection specified in thequalifications in radiation protection specified in the relevant regulations or to be specified in the registrationrelevant regulations or to be specified in the registration or licence will be permitted to prescribe medicalor licence will be permitted to prescribe medical exposure by means of the authorized source.exposure by means of the authorized source. This applies to nuclear medicine 90. Part 3. Principles of Radiation Protection91Nuclear Medicine Authorized legal persons:Authorized legal persons: registrants and licenseesregistrants and licensees BSS 2.15.: Registrants and licensees shall bear theBSS 2.15.: Registrants and licensees shall bear the responsibilityresponsibility for setting up and implementing thefor setting up and implementing the technical and organizational measures that aretechnical and organizational measures that are needed for ensuring protection and safety for theneeded for ensuring protection and safety for the sources for which they are authorized.sources for which they are authorized. They may appoint other people to carry out actionsThey may appoint other people to carry out actions and tasks related to these responsibilities, but theyand tasks related to these responsibilities, but they shall retain the responsibility for the actions and tasksshall retain the responsibility for the actions and tasks themselves.themselves. 91. Part 3. Principles of Radiation Protection92Nuclear Medicine C) RADIATION PROTECTIONC) RADIATION PROTECTION REQUIREMENTSREQUIREMENTS Justification of PracticesJustification of Practices positive net benefitpositive net benefit Dose LimitationDose Limitation dose limitsdose limits Optimization of Protection and SafetyOptimization of Protection and Safety ConstraintsConstraints of various typesof various types guidance levels for medical exposure.guidance levels for medical exposure. 92. Part 3. Principles of Radiation Protection93Nuclear Medicine Radiation protection requirements JUSTIFICATION OF PRACTICES Practices should not be authorized unless the benefits are greater than the detriments, taking account of social, economic and other factors 93. Part 3. Principles of Radiation Protection94Nuclear Medicine DOSE LIMITATION The normal exposure of individuals from authorized practices shall not exceed the dose limits specified in Schedule II of BSS Radiation protection requirements 94. Part 3. Principles of Radiation Protection95Nuclear Medicine OPTIMIZATION OF PROTECTION AND SAFETY Doses to individuals, the number of persons and the likelihood of incurring exposures shall be kept as low as reasonably achievable, economic and social factors taken into account Radiation protection requirements 95. Part 3. Principles of Radiation Protection96Nuclear Medicine DOSE CONSTRAINTS Optimization of protection and safety measures associated with a particular source within a practice shall be subject to dose constraints Radiation protection requirements 96. Part 3. Principles of Radiation Protection97Nuclear Medicine D) MANAGEMENTD) MANAGEMENT REQUIREMENTSREQUIREMENTS Safety CultureSafety Culture Quality AssuranceQuality Assurance Human FactorsHuman Factors Qualified ExpertsQualified Experts 97. Part 3. Principles of Radiation Protection98Nuclear Medicine SAFETY CULTURESAFETY CULTURE Purpose: To encourage a questioning andPurpose: To encourage a questioning and learning attitude to protection and safety,learning attitude to protection and safety, whilst discouraging complacency. Policieswhilst discouraging complacency. Policies and procedures should:and procedures should: identify protection and safety as the highest priorityidentify protection and safety as the highest priority Identify problems promptlyIdentify problems promptly Identify responsibilities of individualsIdentify responsibilities of individuals define clear lines of authority (to the top)define clear lines of authority (to the top) effect lines of communicationeffect lines of communication Management requirements 98. Part 3. Principles of Radiation Protection99Nuclear Medicine QUALITY ASSURANCEQUALITY ASSURANCE Establish QA programme to ensure:Establish QA programme to ensure: that safety and protection requirements arethat safety and protection requirements are satisfiedsatisfied the overall effectiveness of protection and safety isthe overall effectiveness of protection and safety is periodically reviewedperiodically reviewed this requires significant commitment fromthis requires significant commitment from management (logistical and financial resources)management (logistical and financial resources) Management requirements 99. Part 3. Principles of Radiation Protection100Nuclear Medicine HUMAN FACTORSHUMAN FACTORS The contribution of human error toThe contribution of human error to accidents should be minimised by:accidents should be minimised by: training of personneltraining of personnel use of defined proceduresuse of defined procedures use of ergonomic design to minimiseuse of ergonomic design to minimise operating errorsoperating errors use of safety systemsuse of safety systems Management requirements 100. Part 3. Principles of Radiation Protection101Nuclear Medicine QUALIFIED EXPERTSQUALIFIED EXPERTS Identify need and make available,Identify need and make available, for example:for example: Advice on radiation protection andAdvice on radiation protection and safetysafety Servicing and maintenanceServicing and maintenance Calibration, clinical dosimetry...Calibration, clinical dosimetry... Management requirements 101. Part 3. Principles of Radiation Protection102Nuclear Medicine Nuclear Safety Standards (NUSS)-SS No. 50 Radiation Waste Safety Standards (RADWASS)-SS No.111 Security of Sources Defence in Depth Good Engineering Practice E. TECHNICAL REQUIREMENTS 102. Part 3. Principles of Radiation Protection103Nuclear Medicine E. TECHNICALE. TECHNICAL REQUIREMENTSREQUIREMENTS Security of SourcesSecurity of Sources prevent theft, damage andprevent theft, damage and unauthorized useunauthorized use keep under control at all timeskeep under control at all times receiver must posses validreceiver must posses valid authorizationauthorization carry out periodic inventorycarry out periodic inventory 103. Part 3. Principles of Radiation Protection104Nuclear Medicine TECHNICAL REQUIREMENTSTECHNICAL REQUIREMENTS Defense in DepthDefense in Depth use of physical or procedural layers ofuse of physical or procedural layers of protection to prevent accidents or mitigateprotection to prevent accidents or mitigate consequencesconsequences built-in redundancybuilt-in redundancy Good Engineering PracticeGood Engineering Practice equipment and facilities designed toequipment and facilities designed to (inter)national standards(inter)national standards 104. Part 3. Principles of Radiation Protection105Nuclear Medicine F)F) Verification of SafetyVerification of Safety Safety assessmentsSafety assessments Monitoring and verification ofMonitoring and verification of compliancecompliance RecordsRecords 105. Part 3. Principles of Radiation Protection106Nuclear Medicine Safety assessmentsSafety assessments BSS 2.37.: Safety assessments related to protectionBSS 2.37.: Safety assessments related to protection and safety measures for sources within practicesand safety measures for sources within practices shall be made at different stages, including siting,shall be made at different stages, including siting, design, manufacture, construction, assembly,design, manufacture, construction, assembly, commissioning, operation, maintenance andcommissioning, operation, maintenance and decommissioning, as appropriate, in order:decommissioning, as appropriate, in order: (a)(a) to identify the ways in which normal exposures and potentialto identify the ways in which normal exposures and potential exposures could be incurred, account being taken of the effect ofexposures could be incurred, account being taken of the effect of events external to the sources as well as events directly involving theevents external to the sources as well as events directly involving the sources and their associated equipment;sources and their associated equipment; (b) to determine the expected magnitudes of normal exposures and, to(b) to determine the expected magnitudes of normal exposures and, to the extent reasonable and practicable, to estimate the probabilitiesthe extent reasonable and practicable, to estimate the probabilities and the magnitudes of potential exposures; andand the magnitudes of potential exposures; and (c) to assess the quality and extent of the protection and safety(c) to assess the quality and extent of the protection and safety provisions.provisions. 106. Part 3. Principles of Radiation Protection107Nuclear Medicine SAFETY ASSESSMENTSAFETY ASSESSMENT A review of the aspects of design and operation of a source which are relevant to the protection of persons or the safety of the source, including the analysis of the provisions for safety and protection established in the design and operation of the source and the analysis of risks associated with normal conditions and accident situations. 107. Part 3. Principles of Radiation Protection108Nuclear Medicine Monitoring and verification ofMonitoring and verification of compliancecompliance BSS 2.38. Monitoring and measurements shall beBSS 2.38. Monitoring and measurements shall be conducted of the parameters necessary forconducted of the parameters necessary for verification of compliance with the requirements ofverification of compliance with the requirements of the Standards.the Standards. BSS 2.39. For the purposes of monitoring andBSS 2.39. For the purposes of monitoring and verification of compliance, suitable equipment shallverification of compliance, suitable equipment shall be provided and verification procedures introduced.be provided and verification procedures introduced. The equipment shall be properly maintained andThe equipment shall be properly maintained and tested and shall be calibrated at appropriate intervalstested and shall be calibrated at appropriate intervals with reference to standards traceable to national orwith reference to standards traceable to national or international standards.international standards. 108. Part 3. Principles of Radiation Protection109Nuclear Medicine RecordsRecords BSS 2.40.: Records shall beBSS 2.40.: Records shall be maintained of the results of monitoringmaintained of the results of monitoring and verification of compliance, includingand verification of compliance, including records of the tests and calibrationrecords of the tests and calibration carried out in accordance with thecarried out in accordance with the Standards.Standards. 109. Part 3. Principles of Radiation Protection110Nuclear Medicine 110. Part 3. Principles of Radiation Protection111Nuclear Medicine Similar definitions to ICRP Occupational exposure Public exposure Medical exposure EXPOSURES 111. Part 3. Principles of Radiation Protection112Nuclear Medicine Responsibilities forResponsibilities for Occupational ExposureOccupational Exposure BSS Appendix I.1.BSS Appendix I.1. Registrants and licensees andRegistrants and licensees and employers of workers who are engaged in activitiesemployers of workers who are engaged in activities involving normal exposures or potential exposureinvolving normal exposures or potential exposure shall be responsible for:shall be responsible for: (a)(a) the protection of workers from occupationalthe protection of workers from occupational exposure; andexposure; and (b)(b) compliance with any other relevantcompliance with any other relevant requirements of the Standards.requirements of the Standards. 112. Part 3. Principles of Radiation Protection113Nuclear Medicine Dose Limits effective dose of 20mSv per year averaged over five consecutive years effective dose of 50mSv in any single year equivalent dose to lens of eye of 150mSv in a year equivalent dose to extremities or skin of 500mSv in a year. For apprentices (16-18 years of age) effective dose of 6mSv in a year. OCCUPATIONAL - APPENDIX I 113. Part 3. Principles of Radiation Protection114Nuclear Medicine OCCUPATIONAL Female workers should notify pregnancy. Working conditions shall be adapted to ensure that the embryo and fetus are afforded the same broad level of protection as for members of the public.. 114. Part 3. Principles of Radiation Protection115Nuclear Medicine CLASSIFICATION OF AREAS Controlled areas - provisions needed for: controlling normal exposures preventing spread of contamination potential exposures individual monitoring if feasible. Supervised areas - where conditions need to be kept under review: individual monitoring not required, but exposure assessment. OCCUPATIONAL 115. Part 3. Principles of Radiation Protection116Nuclear Medicine Responsibilities forResponsibilities for Medical ExposureMedical Exposure BSS Appendix II.1.BSS Appendix II.1. Registrants and licensees shallRegistrants and licensees shall ensure that:ensure that: (a)(a) no patient be administered a diagnostic orno patient be administered a diagnostic or therapeutic medical exposure unless the exposuretherapeutic medical exposure unless the exposure isis prescribed by a medical practitioner;prescribed by a medical practitioner; (d)(d) for therapeutic uses of radiation, the calibration,for therapeutic uses of radiation, the calibration, dosimetry and quality assurance requirements ofdosimetry and quality assurance requirements of the Standards be conducted by or under thethe Standards be conducted by or under the supervision of a qualified expert in radiotherapysupervision of a qualified expert in radiotherapy physics;physics; 116. Part 3. Principles of Radiation Protection117Nuclear Medicine Justification by weighing diagnostic or therapeutic benefit against radiation detriment, taking into account available alternative techniques. Optimization all other requirements plus safety oriented requirements minimum patient exposure consistent with acceptable image quality and clinical purpose Guidance levels for diagnostic radiological procedures for diagnostic nuclear medicine procedures MEDICAL -APPENDIX II 117. Part 3. Principles of Radiation Protection118Nuclear Medicine MEDICALMEDICAL DOSE CONSTRAINTS DO NOT APPLY TODOSE CONSTRAINTS DO NOT APPLY TO PATIENTS, BUT ARE APPLICABLEPATIENTS, BUT ARE APPLICABLE forfor individuals helpingindividuals helping in care, support orin care, support or comfort of patients, andcomfort of patients, and visitorsvisitors 5mSv during the period of the examination5mSv during the period of the examination or treatmentor treatment 1mSv for children visiting1mSv for children visiting maximum activity inmaximum activity in patients dischargedpatients discharged fromfrom hospitalshospitals Iodine 131-1100 MBqIodine 131-1100 MBq 118. Part 3. Principles of Radiation Protection119Nuclear Medicine MEDICALMEDICAL DOSE CONSTRAINTS APPLICABLEDOSE CONSTRAINTS APPLICABLE forfor medical researchmedical research purposes if the exposurepurposes if the exposure does not produce direct benefit to thedoes not produce direct benefit to the exposed individual (should follow the generalexposed individual (should follow the general recommendations given by WHO and ICRP)recommendations given by WHO and ICRP) 119. Part 3. Principles of Radiation Protection120Nuclear Medicine Responsibilities for PublicResponsibilities for Public Exposure (Exposure (BSS III.2 )BSS III.2 ) III.1. Registrants and licensees shall apply theIII.1. Registrants and licensees shall apply the requirements of the Standards as specified by therequirements of the Standards as specified by the Regulatory Authority to any public exposure deliveredRegulatory Authority to any public exposure delivered by a practice or source for which they areby a practice or source for which they are responsible, unless the exposure is excluded fromresponsible, unless the exposure is excluded from the Standards or the practice or source delivering thethe Standards or the practice or source delivering the exposure is exempted from the requirements of theexposure is exempted from the requirements of the Standards.Standards. 120. Part 3. Principles of Radiation Protection121Nuclear Medicine DOSE LIMITS effective dose of 1mSv in a year in special circumstances, effective dose of 5mSv in a single year, provided that the average over five consecutive years in less than 1mSv per year equivalent dose to lens of the eye 15mSv in a year equivalent dose to skin of 50mSv in a year. PUBLIC - APPENDIX III 121. Part 3. Principles of Radiation Protection122Nuclear Medicine Radioactive Waste (RADWASS) minimize segregate and treat control discharges. Environmental Monitoring Consumer Products PUBLIC 122. Part 3. Principles of Radiation Protection123Nuclear Medicine safety assessment design requirements accident prevention / consequence mitigation operational responsibilities SAFETY OF SOURCES- APPENDIX IV 123. Part 3. Principles of Radiation Protection124Nuclear Medicine emergency plans intervention level EMERGENCY EXPOSURES-EMERGENCY EXPOSURES- APPENDIX VAPPENDIX V 124. Part 3.Part 3. Module 3.3. Regulatory ControlModule 3.3. Regulatory Control IAEA Training Material on Radiation Protection in Nuclear Medicine 125. Part 3. Principles of Radiation Protection126Nuclear Medicine GOVERNMENTAL REGULATIONGOVERNMENTAL REGULATION The Standards are intended to place requirements on those legal persons authorized to conduct practices that cause radiation exposure or to intervene in order to reduce existing exposures; these legal persons have the primary responsibility for applying the Standards. Governments, however, have responsibility for their enforcement through establishment and support of a national infrastructure of radiation protection. 126. Part 3. Principles of Radiation Protection127Nuclear Medicine NATIONAL INFRASTRUCTURE:NATIONAL INFRASTRUCTURE: LEGISLATION REGULATIONS REGULATORY AUTHORITY (INDEPENDENT) - Authorize - Inspect - Enforce GENERAL PROVISIONS / SERVICES - Environmental Monitoring - Intervention - Personal Dosimetry - Calibration - Information Exchange - Training 127. Part 3. Principles of Radiation Protection128Nuclear Medicine REGULATORY AUTHORITYREGULATORY AUTHORITY The Regulatory Authority should be an importantThe Regulatory Authority should be an important national expertise in radiation protection with thenational expertise in radiation protection with the necessary independence andnecessary independence and provisions forprovisions for adequateadequate resources and financial supportresources and financial support.. 128. Part 3. Principles of Radiation Protection129Nuclear Medicine REGULATORY AUTHORITYREGULATORY AUTHORITY ESTABLISHED BYESTABLISHED BY THETHE GOVERNMENTGOVERNMENT Given:Given: - Powers- Powers - Resources- Resources - Independence (effective)- Independence (effective) To:To: - Receive Notifications- Receive Notifications - Carry out assessments- Carry out assessments - Issue Authorizations/Licenses- Issue Authorizations/Licenses - Inspect- Inspect - Enforce- Enforce 129. Part 3. Principles of Radiation Protection130Nuclear Medicine AuthorizationAuthorization To obtain authorization the applicant/licensee should provide evidence of compliance with the BSS with regard to design and construction of facilities, the radionuclides aimed to be used, systems for RP and safety, quality assurance, operation, staff requiring individual authorizations, and the required documentation 130. Part 3. Principles of Radiation Protection131Nuclear Medicine AuthorizationAuthorization The authorization should be renewed periodically. Periods should be based on safety criteria and established by the Regulatory Authority. The Regulatory Authority may consider suspending or revoking an authorization when the licensees are in serious breach of the requirements of the BSS or the national regulations and laws. 131. Part 3. Principles of Radiation Protection132Nuclear Medicine AuthorizationAuthorization The following activities related to Nuclear Medicine should be Authorized: import, distribution, sale or transfer of radioactive substances personal monitoring installation and maintenance of nuclear medicine equipment disposal of radioactive waste 132. Part 3. Principles of Radiation Protection133Nuclear Medicine Application for AuthorizationApplication for Authorization Type of Authorization New Amendment to existing authorization Renewal of authorization Purpose of Application Constructions Import/Purchase Use/Begin operation 133. Part 3. Principles of Radiation Protection134Nuclear Medicine Application for AuthorizationApplication for Authorization General information: Name and address of organization Name and information about qualified experts RPO Medical Physicist Responsible representative of the legal person Proposed date of installation and/or commissioning of facilities and equipment 134. Part 3. Principles of Radiation Protection135Nuclear Medicine Application for AuthorizationApplication for Authorization SOURCES Radionuclides involved in the work Containment of the radionuclides Work pattern Work locations Radioactive waste 135. Part 3. Principles of Radiation Protection136Nuclear Medicine Application for AuthorizationApplication for Authorization FACILITIES AND EQUIPMENT Facility specifications Location Layout Ventilation, plumbing and surfaces Equipment specifications Imaging equipment Activity meter Safety equipment Monitoring equipment 136. Part 3. Principles of Radiation Protection137Nuclear Medicine Application for AuthorizationApplication for Authorization RADIATION PROTECTION PROGRAMME Organizational structure Area classification Individual and workplace monitoring Local rules and supervision Quality assurance Transportation of radioactive material Emergency procedures Radioactive waste Records 137. Part 3. Principles of Radiation Protection138Nuclear Medicine Application for AuthorizationApplication for Authorization MEDICAL EXPOSURE Responsibilities Justification Optimization Calibration Clinical dosimetry Quality assurance Dose constraints Investigation of accidental medical exposures Guidance levels 138. Part 3. Principles of Radiation Protection139Nuclear Medicine INSPECTIONSINSPECTIONS An inspection to assess the status of compliance with regulatory requirements and safety of an authorized operation should be based on direct observation of work activities, interviews with workers, independent measurements of radiation and contamination levels, and review of records. The review and inspection processes should be closely coupled, with reviewers of the application and inspectors and inspectors exchanging experiences. 139. Part 3. Principles of Radiation Protection140Nuclear Medicine INSPECTIONSINSPECTIONS Adequate preparation before the inspection is essential. The inspector should review the documents submitted with the application, and the history of the facility. Appropriate monitoring instruments to measure radiation and contamination levels should be obtained as necessary. An inspection plan as a guide for inspection of the organization's safety programme should be prepared. The plan should prioritize inspection of potential problem areas in the facility. 140. Part 3. Principles of Radiation Protection141Nuclear Medicine INSPECTIONSINSPECTIONS Unannounced inspections The advantage of an unannounced inspection is that it provides the opportunity to see the facility operating under its usual conditions. The disadvantages are that the key personnel may not be available, or part of the facility may not be operating. 141. Part 3. Principles of Radiation Protection142Nuclear Medicine INSPECTIONSINSPECTIONS The facility and operating programmes should be inspected in detail to determine whether they conform to those described in the application. The inspector should verify that the staff present are as described in the application. The inspector should carefully review records. The inspector should interview key members of the staff to elicit information which helps the inspector assess the status of protection and safety 142. Part 3. Principles of Radiation Protection143Nuclear Medicine INSPECTIONSINSPECTIONS The frequency of routine inspections for each facility should be planned according to the hazards and risks associated with the operation of that facility and its previous compliance history. 143. Part 3. Principles of Radiation Protection144Nuclear Medicine Frequency of regular inspectionsFrequency of regular inspections Category A High safety risk; every 1 3 years Category B Medium safety risk; every 3 5 years Category C Low safety risk; every 5 10 years 144. Part 3. Principles of Radiation Protection145Nuclear Medicine INSPECTIONSINSPECTIONS 1. Identifying information 2. Verification of safety 3. Verification of worker protection 4. Verification of public protection 5. Emergency preparedness 6. Medical exposure 7. Records 145. Part 3. Principles of Radiation Protection146Nuclear Medicine INSPECTIONSINSPECTIONS Verification of safety Description of radioactive material in use Description of measuring and handling equipment Facility design Safety control and equipment design Warning systems Safety operation-management Safety operation-technical Investigation and quality assurance 146. Part 3. Principles of Radiation Protection147Nuclear Medicine INSPECTIONSINSPECTIONS Verification of occupational protection Classification of areas Local rules and supervision Monitoring 147. Part 3. Principles of Radiation Protection148Nuclear Medicine INSPECTIONSINSPECTIONS Medical exposure Responsibilities Justification Optimization Calibration Clinical dosimetry Quality assurance Dose constraints Investigation of accidental medical exposures Guidance level 148. Part 3. Principles of Radiation Protection149Nuclear Medicine EnforcementEnforcement Enforcement isEnforcement is Action taken by the Regulatory Authority toAction taken by the Regulatory Authority to ensure that the responsible party correctsensure that the responsible party corrects non-compliance with regulatorynon-compliance with regulatory requirementsrequirements 149. Part 3. Principles of Radiation Protection150Nuclear Medicine Graded enforcement actionsGraded enforcement actions Operations likely not safe Potential threat of health and safety No immediate threat to health and safety (usually regulatory infraction) Based on threat to health and safetyBased on threat to health and safety 150. Part 3. Principles of Radiation Protection151Nuclear Medicine No immediate threat to health and safety (usually regulatory infraction) Graded enforcement actionsGraded enforcement actions Informal or formal instructions to correct theInformal or formal instructions to correct the infraction Operations may continue whileinfraction Operations may continue while corrective measures are takencorrective measures are taken Informal oral instruction should be followed inInformal oral instruction should be followed in writingwriting Examples might be a non-complying or deteriorated warning sign for a controlled area, or the calibration of an instrument not having been carried out by the due date. 151. Part 3. Principles of Radiation Protection152Nuclear Medicine Potential threat of health and safety Graded enforcement actionsGraded enforcement actions Suspension of or restrictions onSuspension of or restrictions on operationsoperations until regulatory infractionuntil regulatory infraction or safety condition isor safety condition is correctedcorrected An example might be a requirement to replace badly cracked and poor quality flooring material in a ward room used for thyroid cancer patients treated with I-131. 152. Part 3. Principles of Radiation Protection153Nuclear Medicine Operations likely not safe Graded enforcement actionsGraded enforcement actions Licensee shows a record of poorLicensee shows a record of poor performanceperformance or adverse safetyor adverse safety conditionsconditions Suspension of or restrictions onSuspension of or restrictions on operationsoperations An example might be the unauthorised use of lung ventilation studies in a room without appropriate air pressure controls used also for ultrasound scans of pregnant women. 153. Part 3. Principles of Radiation Protection154Nuclear Medicine Quest i ons? 154. Part 3. Principles of Radiation Protection155Nuclear Medicine DISCUSSIONDISCUSSION Give examples of non-justified situations in: The practice of nuclear medicine Examination or treatment of a single patient 155. Part 3. Principles of Radiation Protection156Nuclear Medicine A nuclear medicine department which has treated hyperthyroid patients on an outpatient basis for some time proposes to extend its services to include treatment of thyroid cancer patients. A two room area is to be designated for therapy in-patients. What information should be submitted to the Regulatory Authority to allow this extension of the work of the department to be authorised? Discussion 156. Part 3. Principles of Radiation Protection157Nuclear Medicine DiscussionDiscussion A nuclear medicine department in a hospital had taken delivery of a single dose vial of I-131 for treatment of a thyroid cancer patient. A different hospital had ordered a different activity amount of I- 131 from the same supplier (external to the country). The wrong vial was delivered by courier to the first hospital and the dose was administered to the patient. The error was discovered when checks at the second hospital showed the incorrect activity in the vial received by them. Appropriate investigation and enforcement action? 157. Part 3. Principles of Radiation Protection158Nuclear Medicine Where to Get MoreWhere to Get More InformationInformation Further readingsFurther readings IAEA Basic Safety Standards ICRP publication 60 WHO/IAEA. Manual on Radiation Protection in Hospital and General Practices. Volume 1, Basic Requirements (draft manuscript) IAEA. Practice-specific Model Regulations on Radiation Safety in Nuclear Medicine (in preparation)