part 13 iaea training material on radiation protection in nuclear medicine organization and...

Part 13Part 13

IAEA Training Material on Radiation Protection in Nuclear Medicine

Organization and ResponsibilitiesOrganization and Responsibilities

Nuclear Medicine Part 13. Organization and responsibilities 2

ObjectiveObjective

To become familiar with the radiation protection requirements in nuclear medicine including staffing, responsibilities and duties.


ContentsContents Managerial requirements Radiation Protection Committee Radiation Protection Officer Nuclear Medicine Staff Manufacturers/Suppliers Regulatory Authority


Organizational StructureOrganizational StructureRegulatory AuthorityAuthorization and Inspection

LicenseeOverall responsibility for application of BSS

EmployerOverall responsibility

for application of BSS and/or

Nuclear MedicineFacility

Part 13Part 13Organization andOrganization and ResponsibilitiesResponsibilities

Module 13.1: Module 13.1: Managerial RequirementsManagerial Requirements



Responsibilities of Responsibilities of a a LicenseeLicensee

Licensees shall:Licensees shall: Establish radiation safety objectives Establish radiation safety objectives Develop, implement and document a Develop, implement and document a

radiation safety programmeradiation safety programme Ensure compliance with requirements Ensure compliance with requirements

set out in legislation and set out in legislation and regulations regulations


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

Responsibilities of Responsibilities of a a LicenseeLicensee


Hospital Manager (Licensee)

Occupationalhealth service

Radiationprotectioncommittee

Radiationprotection

officer

QualityAssurancecommittee

HeadNuclear Medicine

Nuclear Medicine

Technician

Nuclear MedicineSpecialist

Nuclear MedicinePhysicist

Organization (Large Hospital)


Hospital Manager (Licensee)

Occupationalhealth service

Head of Department

Radiationprotection

officer

QualityAssurancecommittee

Radiationprotectioncommittee

Nuclear Medicine

Technician

Nuclear MedicineSpecialist

Nuclear MedicinePhysicist

Organization (Small Hospital)


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


Radiation Protection ProgramRadiation Protection Program Determine measures and resources required Determine measures and resources required

to meet objectives and ensure they are to meet objectives and ensure they are providedprovided

Review measures and resources regularlyReview measures and resources regularly Identify failures and shortcomings and take Identify failures and shortcomings and take

steps to prevent themsteps to prevent them Establish consultation and co-operation of all Establish consultation and co-operation of all

partiesparties Maintain records of activitiesMaintain records of activities


Typical Elements of a RPPTypical Elements of a RPP Assignment of responsibilitiesAssignment of responsibilities The Radiation Protection OfficerThe Radiation Protection Officer Designation of radiation areasDesignation of radiation areas Local rulesLocal rules Education and trainingEducation and training Planning for accidents and emergenciesPlanning for accidents and emergencies Health surveillance and monitoringHealth surveillance and monitoring Review and audit Review and audit System of recording and reportingSystem of recording and reporting


Documentation of RPP Documentation of RPP •The assignment of responsibilities for radiation protection and safety to individuals or to positions within the organization, including corresponding organizational arrangements and, if applicable (for example, in the case of itinerant workers), the allocation of the respective responsibilities between employers and the licensee;

•The classification of controlled or supervised areas;

•The local rules for workers to follow and the supervision of work;

•The arrangements for monitoring workers and the workplace, including the acquisition and maintenance of radiation protection instruments;

•The system for recording and reporting all the relevant information related to the control of exposures (occupational and public), safety of sources including waste management, the decisions regarding measures for radiation protection and safety, and the assessment of doses to occupationally exposed individuals.


Documentation of RPP Documentation of RPP

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


Local RulesLocal Rules

Local rulesLocal rules are intended to provide are intended to provide adequate levels of protection and safety adequate levels of protection and safety through the establishment of common through the establishment of common work procedures and other systems to work procedures and other systems to be followed by all workers in the areabe followed by all workers in the area

They should include all information They should include all information required for work in the area, and be required for work in the area, and be made known to all workers made known to all workers


Local RulesLocal RulesSet down in writing :Set down in writing : person(s) responsible for supervising the person(s) responsible for supervising the

workwork description of controlled and supervised description of controlled and supervised

areasareas general radiation safety measuresgeneral radiation safety measures dose investigation levelsdose investigation levels emergency plansemergency plans


Radiation Safety ManualRadiation Safety Manual

The RSM is ideally a local reference book, The RSM is ideally a local reference book, and made available to (and possibly and made available to (and possibly mandatory reading for) all radiation workers mandatory reading for) all radiation workers

An effective aid to training, and a valuable An effective aid to training, and a valuable tool in itself is a Radiation Safety Manualtool in itself is a Radiation Safety Manual

This now is required practice in many This now is required practice in many countriescountries

Radiation Safety Manual


Radiation Safety ManualRadiation Safety Manual

The RSM should include sections on :The RSM should include sections on : basics of radiation safetybasics of radiation safety sources, risks and effects of radiationsources, risks and effects of radiation local radiation safety organizationlocal radiation safety organization national/state regulationsnational/state regulations personnel monitoringpersonnel monitoring emergency proceduresemergency procedures

Module 13.2: Module 13.2: Radiation Protection CommitteeRadiation Protection Committee




Radiation Protection CommitteeRadiation Protection Committee

•review and oversee compliance with, and implementation of, the RPP;

•formulate radiation protection policies to update and improve the RPP;

•provide the RPO with guidance on operational aspects of the RPP, and request actions on specific matters;

•investigate any radiation incidents or accidents and provide a comprehensive report on these to the employer; and

•assess potential hazards from foreseeable incidents and prepare contingency plans.



The RPC shall recommend actions to the licensee to:The RPC shall recommend actions to the licensee to:

correct identified deficiencies in the RPP; correct identified deficiencies in the RPP; review new uses of radiation sources that may lead review new uses of radiation sources that may lead

to modifications of the RPP; to modifications of the RPP; identify any amendments to the licence;identify any amendments to the licence; identify staff needing personal authorization; andidentify staff needing personal authorization; and periodically review the training programme.periodically review the training programme.



RPC should be composed of clinical staff representing the hospital departments using radiation sources, medical physicists and persons who have special knowledge of the hazards of radiation and are experienced in radiation protection. Also included should be a representative of the hospital’s administrative unit, and a union or staff representative. The radiation protection officer, and possibly a physician from the occupational health service should also be members.

The RPC should hold meetings at least every three months, and perform comprehensive internal audits annually, or when necessary, and report the outcome of its activities to the licensee/management.

Module 13.3Module 13.3

Radiation Protection OfficerRadiation Protection Officer




Radiation Protection Officer (1/4)Radiation Protection Officer (1/4)• providing a link between the RPC and the users of radiation within the institution;

•supervising operational aspects of the RPP;

•providing practical advice on implementation of local rules and procedures;

•identifying deficiencies in compliance with the RPP and reporting to the licensee and the RPC;

•identifying training needs and organizing training activities;

•systematically verifying that tasks requiring personal authorization are only performed by staff with a valid authorization;

•monitoring source security: receiving sources and maintaining the source inventory;

•co-operating with officers of the Regulatory Authority and facilitating internal and external audits;


Radiation Protection Officer (2/4)Radiation Protection Officer (2/4)•contributing to the planning and design of any new or modified radiation facility;

•undertaking the radiation safety assessment of new installations, processes and equipment, prior to their acceptance;

•identifying and establishing controlled and supervised areas;

•specifying appropriate monitoring procedures;

•ensuring that enough radiation monitoring instruments are available and that they are calibrated and serviced as required;

•implementing a personal and workplace monitoring programme;

•systematically and periodically reviewing monitoring programme in all areas where radiation sources are used, stored or disposed of;

•analysing and interpreting radiation monitoring data;

•informing all radiation users of their personal doses and ensuring that these are consistent with optimization;


Radiation Protection Officer (3/4)Radiation Protection Officer (3/4)•ensuring that appropriate measures are taken to control the exposure of a pregnant employee;

•assessing potential hazard from foreseeable incidents and drafting contingency plans;

•exercising and carrying out emergency procedures;

•being available for consultation on radiation protection matters;

•ensuring that appropriate action is taken when an employee reports a matter which can compromise radiation protection;

•ensuring that appropriate radiation protection training is provided on a regular basis as part of an ongoing "radiation protection awareness programme" for all users and for those who occasionally come into contact with radiation sources (i.e. cleaning staff, security, maintenance people);

•ensuring that necessary leak testing of sealed sources is performed;


Radiation Protection Officer (4/4)Radiation Protection Officer (4/4)

•supervising decontamination procedures;

•providing instruction to nursing staff on the correct procedures for handling and disposal of soiled linen and for dealing with spillage of urine from patients receiving bone pain palliation therapy;

•providing waste disposal procedures in accordance with the conditions of the licence or as specified by the Regulatory Authority;

•investigating all overexposures, accidents and losses of radiation sources and reporting to the RPC/Regulatory Authority as necessary;

•maintaining required records; and

•preparing a comprehensive annual report for the RPC and for forwarding to the Regulatory Authority if required.


Nuclear Medicine StaffNuclear Medicine Staff




ensuring overall radiation protection of the patient;

prescribing and justifying diagnosis and therapy in writing, taking into account relevant information from previous examinations;

ensuring that the exposure of patients is the minimum required to achieve the intended objective taking into account the relevant guidance levels for medical exposure;

providing consultation and clinical evaluation of patients;

establishing optimized protocols for diagnostic and therapeutic procedures, in consultation with the medical physicist;

evaluating any radiation incident or accident from a medical point of view; and

providing criteria to manage the examination of pregnant women, paediatric patients, medico-legal procedures, occupational health examinations and medical and biomedical research.

Nuclear Medicine SpecialistNuclear Medicine Specialist


Medical PhysicistMedical Physicist

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


Nuclear Medicine TechnologistNuclear Medicine Technologist

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


Nuclear Medicine TechnologistNuclear Medicine Technologist

The technologist may have the following additional The technologist may have the following additional responsibilities, which - alternatively - may be the responsibility responsibilities, which - alternatively - may be the responsibility of a of a radiochemistradiochemist or or radiopharmacistradiopharmacist::

Elution of sterile pertechnetate from a 99Mo/99mTc generator;Preparation of radiopharmaceuticals from lyophilized kits according to the manufacturer’s instructions; andPerformance of quality control procedures on the prepared radiopharmaceuticals.


Manufacturers and SuppliersManufacturers and Suppliers




Authorized ServicesAuthorized Services

Considering that, according to the BSS, the activities listed below also require authorization, regulatory authorities may require the licensee of a nuclear medicine practice to contract any of the following services only to enterprises authorized by the Regulatory Authority:

import, distribution, sale or transfer of radioactive sourcespersonal monitoringinstallation, maintenance of nuclear medicine equipment disposal of radioactive sources


Manufacturer/SupplierManufacturer/Supplier

Design facilities for likely conditions of useDesign facilities for likely conditions of use Transport sources as per IAEA ST-1Transport sources as per IAEA ST-1 Approval test prototype devicesApproval test prototype devices Provide certificate of conformityProvide certificate of conformity Provide instructions for safe use and Provide instructions for safe use and

maintenancemaintenance


Regulatory AuthorityRegulatory Authority




Regulatory AuthorityRegulatory AuthorityTechnical services:Technical services:

Dosimetry servicesDosimetry services

Laboratory servicesLaboratory services

Calibration servicesCalibration services

Waste managementWaste management

Medical servicesMedical services

Training servicesTraining services

Expert assistanceExpert assistance


Regulatory AuthorityRegulatory Authority

The Regulatory Authority should be an important The Regulatory Authority should be an important national expertise in radiation protectionnational expertise in radiation protection..


Questions?


DiscussionDiscussion

In a department having a newly installed gamma camera, the collimator fell off and killed a patient. Who is responsible?


DiscussionDiscussion

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


Where to Get MoreWhere to Get More InformationInformation

Further readingsFurther readings IAEA, International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources Safety Series No.115, Interim Edition (2011)WHO/IAEA/PAHO/EC. Manual on Radiation Protection in Hospital and General Practices. Volume 1, Basic Requirements IAEA. Practice-specific Model Regulations on Radiation Safety in Nuclear MedicineIAEA, Organization and Implementation of a National Regulatory Infrastructure Governing Protection against Ionizing Radiation and the Safety of Radiation Sources, IAEA-TECDOC-1067, Vienna (1999).

part 13 iaea training material on radiation protection in nuclear medicine organization and...

Documents

nuclear medicine organization

radiation protection

licensee slide

radiation safety programme

radiation safety objectives

responsibilities module

clear responsibilities

training of personnel