II. FUNCTIONS AND RESPONSIBILITIES

Each component of the Duke University Radiation Safety chain of organization has specific responsibilities concerning the safe use of radioactive material and radiation sources. Many of these are stipulations of North Carolina radiation protection regulations. The functions, responsibilities, and enforcement duties of the major components are as follows:

  1. ADMINISTRATION

    2. The Duke University/Medical Center Administration is responsible for:

    1. Establishment of a formal radiation safety structure that includes Radiation Safety Committees for Duke University and Duke University Medical Center and appointment of a Radiation Safety Officer.
    2. Institutional oversight for specific accelerator licenses at Duke University/Medical Center through the Committees and the Radiation Safety Officer.
    3. Commitment to the ALARA program.

  2. COMMITTEES

    3. The Duke University Committee on Radiological Safety (hereafter referred to as the "University Committee"), the Duke University Medical Center Radiation Control and Radioactive Drug Research Committee (hereafter referred to as the "Medical Center Committee"), and each Local Accelerator Radiation Safety Committee shall:

    1. Determine the adequacy of the training and experience of Authorized Users to possess and use radioactive material and radiation sources under the University and Medical Center's licenses.
    2. Review applications for the use of radiation to determine the adequacy of associated equipment, facilities and safety procedures.
    3. Establish maximum permissible occupational radiation levels for keeping individual and collective doses as low as reasonably achievable (ALARA).
    4. Require any Authorized User of radioactive material, radiation-producing devices and/or lasers to allow inspections to assure safe operation.
    5. Provide oversight for the specific accelerator licenses.
    6. Require cessation of any operation involving radiation upon a determination of inadequate safety procedures.
    7. Meet at least four times a year to review matters pertaining to radiation safety, and receive a status report on such matters from the Radiation Safety Officer. The Chairs of the Committees have the authority to make temporary policy decisions when a formal Committee meeting cannot be scheduled in a timely fashion. Such temporary policy decisions are subject to a full review by the Committee at its next meeting.
    8. Meet at the call of the Chairman to resolve matters of an emergency nature relating to health and safety arising from the use of radiation.
    9. Participate in an annual review of the Radiation Safety Program, in conjunction with the Radiation Safety Officer.
    10. Advise the Duke Administration regarding matters of radiation protection.
    11. Provide oversight of the safe operation of lasers through formation of Laser Safety Committees. Policies and procedures of the Laser Safety Committees shall be implemented through the Laser Safety Manager.

    In addition, each Local Accelerator Radiation Safety Committee shall:

    1. Review and approve all proposed changes to the facility, procedures and technical specifications.
    2. Assist in design of new accelerator configurations.
    3. Review the operation and operational records of the facility.
    4. Review unusual or abnormal occurrences or performance of equipment which are reportable under State of North Carolina Regulations.
    5. Review and approve Authorized Accelerator Operators.

  3. RADIATION SAFETY OFFICER AND DIVISION

    1. The Radiation Safety Officer shall:
      1. Determine compliance with policies issued by the Committees and by Federal, State and Local agencies.
      2. Supervise radiation control activities.
      3. Investigate all proposals for the use of radionuclides and radiation-producing devices and conditions of their use and transmit such proposals to the Committees with recommendations for approval or disapproval. This includes proposals for the investigational use of radioactive drugs in humans, in conjunction with the Radioactive Drug Research Committee.
      4. Have the authority to halt operations involving radioactive material or radiation machines if unsafe or unacceptable conditions exist.
      5. Control acquisition and transfers of radionuclides to individuals on and off campus and ensure that individual and institutional possession limits are not exceeded.
      6. Implement institutional accelerator safety policies and regulations, as determined by the Committees.
      7. Through the Laser Safety Manager, implement the policies and procedures of the Laser Safety Committees.
      8. Prepare an annual report for each radiation safety program.
      9. Prepare license amendments and maintain timely renewals of licenses.
    2. The Radiation Safety Division, under the supervision of the Radiation Safety Officer, shall:
      1. Maintain radiation dosimetry records of all persons issued personnel monitors and maintain records of bioassay results.
      2. Maintain a registry of all campus facilities subject to the radiation safety program.
      3. Maintain records of radioisotope procurement and disposal in a form suitable for rapid retrieval and reporting to regulatory agencies.
      4. Assist users in the storage, use and disposal of radioactive material at the laboratory level.
      5. Audit laboratories through meetings with Authorized Users and their designees and periodic inspection of operations, reporting any issues of non-compliance to the Radiation Safety Officer.
      6. Monitor the Authorized Users' procurement, transportation, storage, use and disposal of radioactive materials to ensure compliance with the State of North Carolina licenses, the institutional ALARA program and applicable USDOT and EPA regulations.
      7. Coordinate a radioactive waste management program for waste to be disposed of outside the laboratory setting in conjunction with the Environmental Programs Division of OESO. This includes receipt of waste, decay-in-storage, burial, incineration and disposal through commercial vendors.
      8. Provide operational support to the Laser Safety Manager.
      9. Calibrate radiation survey instruments for Authorized Users when required.
      10. Perform leak tests on sealed sources as required by State regulations.
      11. Receive, inspect and distribute incoming shipments of radioisotopes as required by North Carolina State and USDOT regulations.
      12. Conduct educational programs in the safe use of radionuclides and radiation-producing machines through formal courses.
      13. Conduct an environmental monitoring program to ensure regulatory compliance.
      14. Investigate incidents involving radioactive material or violations of regulations.
      15. Respond to emergencies and supervise decontamination operations by the Authorized Users.
      16. Monitor inpatient therapies utilizing unencapsulated or encapsulated radioactive material as required, and assist in determining when appropriate discharge criteria have been met.

  4. ACCELERATOR FACILITIES

    1. Each Accelerator Director shall:
      1. Establish a local Accelerator Radiation Safety Committee structure that includes appointing local Committee members and a local Radiation Safety Manager.
      2. Provide an operational budget and necessary personnel support for the management of the accelerator radiation safety program.
      3. Function as a representative of the Duke Administration in the local Accelerator Radiation Safety Committee meetings.
      4. Commit to the ALARA program.
    2. Each local accelerator Radiation Safety Manager shall:
      1. Be authorized to terminate immediately any project or operation that is found to be a threat to the health of employees and/or members of the public, or to the property or environment of the University and local community. Such operational decisions are subject to full review by the institutional Committees and the institutional Radiation Safety Officer.
      2. Execute established radiation safety policies and ensure compliance with State of North Carolina license conditions.
      3. Supervise radiation control activities.
      4. Halt accelerator operations if unsafe or unacceptable conditions exist.

  5. DUML RADIATION SAFETY MANAGER

    6. The Duke University Marine Laboratory (DUML) does not have a full-time Radiation Safety Officer on site. Therefore the Marine Laboratory Director shall appoint a Radiation Safety Manager who will act as a representative of the Radiation Safety Officer. The DUML Radiation Safety Manager is responsible for:

    1. Approval of all DUML radioisotope purchase orders.
    2. Ensuring that received radioactive packages are checked in compliance with the applicable regulations.

  6. AUTHORIZED USER

    7. Each Authorized User shall:

    1. Develop written procedures for the use of radiation sources or radioactive material as appropriate for the intensity and scope of the activities covered in the Authorized User's laboratory and commensurate with good radiation protection practices.
    2. Furnish all information requested by the Committee or Radiation Safety Officer concerning his/her qualifications, facilities, equipment and safety procedures.
    3. Maintain records as required by this Manual.
    4. Designate an alternate Authorized User to provide oversight of his/her laboratory operations during absences exceeding thirty days, and to transmit this information to the Radiation Safety Officer.
    5. Comply with the applicable portions of this Manual to the best of his/her ability.
    6. Ensure that each individual using radioisotopes under his/her supervision has received radiation safety training appropriate to such use and to include special instructions for pregnant women or women of child-bearing potential.
    7. Notify the Radiation Safety Officer of any changes in authorization status.
    8. Notify the Radiation Safety Officer of intention to terminate the Authorization, no later than thirty days prior to the proposed termination.

  7. RADIATION WORKER

    8. Each individual working with unsealed radioactive material, sealed sources or radiation-producing machines shall:

    1. Understand and implement the appropriate radiation safety precautions for the specific radioactive nuclide(s) being used.
    2. Conduct operations so as to minimize exposure (internal and external) to all personnel in the laboratory.
    3. Wear a personnel monitor as directed in Chapter V (Personnel Monitoring) and make the monitor available for scheduled exchanges.
    4. Periodically survey his/her hands, feet and clothing, and the work area for contamination.
    5. Periodically survey around storage and waste areas.

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