Transcript Radiation Protection in Nuclear Medicine

IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 13
Organization and Responsibilities
Objective
To become familiar with the radiation protection
requirements in nuclear medicine including staffing,
responsibilities and duties.
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Contents
Managerial requirements
 Radiation Protection Committee
 Radiation Protection Officer
 Nuclear Medicine Staff
 Manufacturers/Suppliers
 Regulatory Authority

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Organizational Structure
Regulatory Authority
Authorization and Inspection
Licensee
Employer
Overall responsibility
for application of BSS
and/or
Overall responsibility
for application of BSS
Nuclear Medicine
Facility
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 13
Organization and Responsibilities
Module 13.1: Managerial Requirements
Responsibilities of a Licensee
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Licensees shall:
Establish radiation safety objectives
 Develop, implement and document a
radiation safety programme
 Ensure compliance with requirements
set out in legislation and regulations
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Responsibilities of a Licensee
The licensee may appoint other people to carry out
actions and tasks related to these responsibilities, but
they shall retain the responsibility for the actions and
tasks themselves. Registrants and licensees shall
specifically identify individuals responsible for
ensuring compliance with the Standards.
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Organization (Large Hospital)
Hospital Manager (Licensee)
Occupational
health service
Radiation
protection
committee
Radiation
protection
officer
Head
Nuclear
Medicine
Nuclear
Medicine
Specialist
Nuclear Medicine
Quality
Assurance
committee
Nuclear
Medicine
Technician
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Nuclear
Medicine
Physicist
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Organization (Small Hospital)
Hospital Manager (Licensee)
Quality
Assurance
committee
Head of
Department
Radiation
protection
committee
Occupational
health service
Nuclear
Medicine
Specialist
Nuclear Medicine
Radiation
protection
officer
Nuclear
Medicine
Technician
Part 13. Organization and responsibilities
Nuclear
Medicine
Physicist
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Administrative Manager
•Appoint the necessary personnel and ensure
the individuals have the necessary education
to perform their duties.
•Establish a radiation protection programme
and provide the necessary resources.
•Assign clear responsibilities for personnel.
•Appoint a Radiation Protection Officer.
•Establish a Radiation Protection Committee
•Establish a comprehensive QA programme.
•Support education and training of personnel.
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Radiation Protection Program
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Determine measures and resources required
to meet objectives and ensure they are
provided
Review measures and resources regularly
Identify failures and shortcomings and take
steps to prevent them
Establish consultation and co-operation of all
parties
Maintain records of activities
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Typical Elements of a RPP
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Assignment of responsibilities
The Radiation Protection Officer
Designation of radiation areas
Local rules
Education and training
Planning for accidents and emergencies
Health surveillance and monitoring
Review and audit
System of recording and reporting
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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.
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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.
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Local Rules
Local rules are intended to provide
adequate levels of protection and safety
through the establishment of common
work procedures and other systems to
be followed by all workers in the area
 They should include all information
required for work in the area, and be
made known to all workers

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Local Rules
Set down in writing :
 person(s) responsible for supervising the
work
 description of controlled and supervised
areas
 general radiation safety measures
 dose investigation levels
 emergency plans
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Radiation Safety Manual
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The RSM is ideally a local reference book,
and made available to (and possibly
mandatory reading for) all radiation workers
An effective aid to training, and a valuable
tool in itself is a Radiation Safety Manual
This now is required practice in many
countries
Radiation Safety Manual
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Radiation Safety Manual

The RSM should include sections on :
basics of radiation safety
 sources, risks and effects of radiation
 local radiation safety organization
 national/state regulations
 personnel monitoring
 emergency procedures
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 13
Organization and Responsibilities
Module 13.2: Radiation Protection Committee
Radiation Protection Committee
•review and oversee compliance with, and implementation of,
the RPP;
•formulate radiation protection policies to update and improve
the RPP;
•provide the RPO with guidance on operational aspects of the
RPP, and request actions on specific matters;
•investigate any radiation incidents or accidents and provide a
comprehensive report on these to the employer; and
•assess potential hazards from foreseeable incidents and
prepare contingency plans.
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Radiation Protection Committee
The RPC shall recommend actions to the licensee to:
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correct identified deficiencies in the RPP;
review new uses of radiation sources that may lead
to modifications of the RPP;
identify any amendments to the licence;
identify staff needing personal authorization; and
periodically review the training programme.
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Radiation Protection Committee
RPC should be composed of clinical staff representing the
hospital departments using radiation sources, medical physicists
and persons who have special knowledge of the hazards of
radiation and are experienced in radiation protection. Also
included should be a representative of the hospital’s
administrative unit, and a union or staff representative. The
radiation protection officer, and possibly a physician from the
occupational health service should also be members.
The RPC should hold meetings at least every
three months, and perform comprehensive
internal audits annually, or when necessary, and
report the outcome of its activities to the
licensee/management.
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 13
Organization and Responsibilities
Module 13.3
Radiation Protection Officer
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;
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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;
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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;
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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.
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 13
Organization and Responsibilities
Module 13.4
Nuclear Medicine Staff
Nuclear Medicine Specialist
ensuring overall radiation protection of the patient;
prescribing and justifying diagnosis and therapy in
writing, taking into account relevant information from
previous examinations;
ensuring that the exposure of patients is the minimum
required to achieve the intended objective taking into account
the relevant guidance levels for medical exposure;
providing consultation and clinical evaluation of patients;
establishing optimized protocols for diagnostic and therapeutic procedures, in
consultation with the medical physicist;
evaluating any radiation incident or accident from a medical point of view; and
providing criteria to manage the examination of pregnant women, paediatric
patients, medico-legal procedures, occupational health examinations and
medical and biomedical research.
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Medical Physicist
-participating in the continuing review of the nuclear medicine practice’s
resources (including budget, equipment, and staffing), operations,
policies and procedures;
-planning, in conjunction with the nuclear medicine physician and the
RPO, the facilities for nuclear medicine practice;
-preparing performance specifications for equipment with regard to
radiation protection;
-carrying out acceptance testing of equipment;
-supervising equipment maintenance;
-designing, implementing and supervising QA procedures;
-performing dose calculations;
-participating in the investigation and evaluation of incidents and
accidents; and
-contributing to the radiation protection training programme
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Nuclear Medicine Technologist
•Patient identification;
•Patient information;
•Information to accompanying persons and staff nursing a patient after a nuclear
medicine examination or therapy;
•Verifying that the female patient is non-pregnant;
•Assure that a mother in lactation is given information about discontinuation of
nursing;
•Make the calculation of administered activity to a child according to the local
rules;
•Verify the administered radiopharmaceutical and its activity;
•Perform regular quality control of activity meter and other relevant equipment;
•Perform regular workplace monitoring;
•Correct handling of the equipment and safety accessories;
•Inform the RPO in the case of accident or incident;
•Inform the Nuclear Medicine Physician in the case of misadministrations;
•Participate in education and training of new personnel.
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Nuclear Medicine Technologist
The technologist may have the following additional
responsibilities, which - alternatively - may be the responsibility
of a radiochemist or radiopharmacist:
Elution
of sterile pertechnetate from a
99Mo/99mTc generator;
Preparation of radiopharmaceuticals
from lyophilized kits according to the
manufacturer’s instructions; and
Performance of quality control
procedures on the prepared
radiopharmaceuticals.
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 13
Organization and Responsibilities
Module 13.5
Manufacturers and Suppliers
Authorized Services
Considering that, according to the BSS, the activities listed
below also require authorization, regulatory authorities may
require the licensee of a nuclear medicine practice to contract
any of the following services only to enterprises authorized by
the Regulatory Authority:
import, distribution, sale or transfer of radioactive
sources
personal monitoring
installation, maintenance of nuclear medicine
equipment
disposal of radioactive sources
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Manufacturer/Supplier
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Design facilities for likely conditions of use
Transport sources as per IAEA ST-1
Approval test prototype devices
Provide certificate of conformity
Provide instructions for safe use and
maintenance
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 13
Organization and Responsibilities
Module 13.6
Regulatory Authority
Regulatory Authority
Technical services:
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Dosimetry services
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Laboratory services
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Calibration services
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Waste management
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Medical services
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Training services
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Expert assistance
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Regulatory Authority
The Regulatory Authority should be an important
national expertise in radiation protection.
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Questions?
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Discussion
In a department having a newly installed gamma
camera, the collimator fell off and killed a patient.
Who is responsible?
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Discussion
A private clinic is setting up a practice of
thyroid treatments (5 patients/week, max
1GBq I-131). How should they organize the
radiation protection?
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Where to Get More Information
Further
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 Medicine
IAEA, Organization and Implementation of a National
Regulatory Infrastructure Governing Protection against Ionizing
Radiation and the Safety of Radiation Sources, IAEA-TECDOC1067, Vienna (1999).

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