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					  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.




Nuclear Medicine    Part 13. Organization and responsibilities   2
                       Content
              Managerial requirements
              Radiation Protection Committee
              Radiation Protection Officer
              Nuclear Medicine Staff
              Manufacturers/Suppliers
              Regulatory Authority




Nuclear Medicine       Part 13. Organization and responsibilities   3
            Organizational Structure
                         Regulatory Authority
                         Authorization and Inspection

                   Licensee                                                 Employer
           Overall responsibility            and/or                    Overall responsibility
           for application of BSS                                     for application of BSS



                               Nuclear Medicine
                                   Facility



Nuclear Medicine               Part 13. Organization and responsibilities                       4
    IAEA Training Material on Radiation Protection in Nuclear Medicine




                        Part 13
Organization and Responsibilities




 Module 13.1: Managerial requirements
Responsibilities of a licensee


          Licensees shall:
              establish radiation safety objectives
              develop, implement and document a
               radiation safety programme
              ensure compliance with requirements
               set out in legislation and regulations



 Nuclear Medicine         Part 13. Organization and responsibilities   6
 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.




 Nuclear Medicine    Part 13. Organization and responsibilities   7
  Organization (Large Hospital)
                     Hospital Manager (Licensee)



                              Radiation                             Quality
       Occupational
                              protection                           Assurance
       health service
                              committee                            committee



               Radiation                                  Head
               protection                                Nuclear
                 officer                                 Medicine


                             Nuclear                     Nuclear               Nuclear
                            Medicine                     Medicine              Medicine
                            Specialist                  Technician             Physicist



Nuclear Medicine                  Part 13. Organization and responsibilities               8
  Organization (Small Hospital)

                          Hospital Manager (Licensee)


            Quality                                                                 Radiation
           Assurance                    Head of
                                                                                    protection
           committee                   Department
                                                                                      officer

                                                                                    Radiation
        Occupational
                                                                                    protection
        health service
                                                                                    committee


                    Nuclear               Nuclear                            Nuclear
                   Medicine               Medicine                           Medicine
                   Specialist            Technician                          Physicist


Nuclear Medicine                Part 13. Organization and responsibilities                       9
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.

Nuclear Medicine   Part 13. Organization and responsibilities   10
    Radiation Protection Program
   Determine measures and resources required
    to meet objectives and ensure they are
    provided
   Review measures and resources regularly
   Identify failures and shortcomings and take
    steps to prevent them
   Establish consultation and co-operation of all
    parties
   Maintain records of activities

Nuclear Medicine    Part 13. Organization and responsibilities   11
Typical elements of a RPP
   Assignment of responsibilities
   The Radiation Protection Officer
   Designation of radiation areas
   Local rules
   Education and training
   Planning for accidents and emergencies
   Health surveillance and monitoring
   Review and audit
   System of recording and reporting
Nuclear Medicine   Part 13. Organization and responsibilities   12
                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.

 Nuclear Medicine            Part 13. Organization and responsibilities   13
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.



Nuclear Medicine          Part 13. Organization and responsibilities   14
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

Nuclear Medicine   Part 13. Organization and responsibilities   15
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



Nuclear Medicine   Part 13. Organization and responsibilities   16
Radiation Safety Manual
   The RSM is ideally a local reference book,
    and made available to (and possibly
    mandatory reading for) all radiation workers
   An effective aid to training, and a valuable
    tool in itself is a Radiation Safety Manual
   This now is required practice in many
    countries
                   Radiation Safety Manual


Nuclear Medicine    Part 13. Organization and responsibilities   17
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



Nuclear Medicine      Part 13. Organization and responsibilities   18
      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.



Nuclear Medicine       Part 13. Organization and responsibilities   20
RADIATION PROTECTION COMMITTEE

      The RPC shall recommend actions to the licensee to:

           correct identified deficiencies in the RPP;
           review new uses of radiation sources that may lead
            to modifications of the RPP;
           identify any amendments to the licence;
           identify staff needing personal authorization; and
           periodically review the training programme.




Nuclear Medicine             Part 13. Organization and responsibilities   21
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.



Nuclear Medicine       Part 13. Organization and responsibilities   22
    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;

 Nuclear Medicine           Part 13. Organization and responsibilities   24
 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;

 Nuclear Medicine          Part 13. Organization and responsibilities   25
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;

Nuclear Medicine          Part 13. Organization and responsibilities   26
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          Part 13. Organization and responsibilities   27
    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.

Nuclear Medicine             Part 13. Organization and responsibilities   29
 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




  Nuclear Medicine             Part 13. Organization and responsibilities    30
 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.

  Nuclear Medicine            Part 13. Organization and responsibilities   31
           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.



Nuclear Medicine         Part 13. Organization and responsibilities   32
    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



Nuclear Medicine                    Part 13. Organization and responsibilities   34
   Manufacturer/Supplier

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




Nuclear Medicine          Part 13. Organization and responsibilities   35
    IAEA Training Material on Radiation Protection in Nuclear Medicine




                        Part 13
Organization and Responsibilities




                 Module 13.6
              Regulatory Authority
                       Regulatory Authority
    Technical services:
                  Dosimetry services
                  Laboratory services
                  Calibration services
                  Waste management
                  Medical services
                  Training services
                  Expert assistance

Nuclear Medicine                Part 13. Organization and responsibilities   37
REGULATORY AUTHORITY

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




Nuclear Medicine      Part 13. Organization and responsibilities   38
                   Questions?



Nuclear Medicine     Part 13. Organization and responsibilities   39
                   DISCUSSION

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




Nuclear Medicine       Part 13. Organization and responsibilities   40
                    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?




Nuclear Medicine          Part 13. Organization and responsibilities   41
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, (1996)
          WHO/IAEA/PAHO/EC. Manual on Radiation Protection in
          Hospital and General Practices. Volume 1, Basic Requirements
          (draft)
          IAEA. Practice-specific Model Regulations on Radiation Safety
          in Nuclear Medicine (in preparation)
          IAEA, Organization and Implementation of a National
          Regulatory Infrastructure Governing Protection against Ionizing
          Radiation and the Safety of Radiation Sources, IAEA-TECDOC-
          1067, Vienna (1999).

Nuclear Medicine               Part 13. Organization and responsibilities   42