I. INTRODUCTION

The purpose of this manual is to describe the policies and procedures of the Radiation Protection Program for Duke University and the Duke University Medical Center. Specific conditions of the North Carolina Radioactive Material Licenses issued to Duke University and Duke University Medical Center require the establishment of peer committees to evaluate proposals for the use of radionuclides, the appointment of a radiation safety officer, and the implementation of a radiation safety program. In addition, the University and Medical Center administrations have determined that the use of radiation producing machines and non-ionizing radiation sources be included in the radiation safety program. These Radiation Safety policies are intended to ensure that such use is in accordance with applicable State and Federal regulations and accepted standards as directed towards the protection of health and the minimization of hazard to life or property.

The statutory basis of the Radiation Safety guidelines of the Duke University Radiation Safety Program includes 15A NCAC 11 (North Carolina Regulations for Protection Against Radiation), 10 CFR 20 (Title 10 Code of Federal Regulations, Part 20) and 10 CFR 35. In addition, stipulations of the Food and Drug Administration, the United States Department of Transportation, the Occupational Safety and Health Administration, the North Carolina Department of Environment and Natural Resources, and the Joint Commission on Accreditation of Health Care Organizations contribute to the regulatory environment.

Due to frequent changes in the regulatory climate, and changes in the needs of the users of radioactive material at Duke University, all policies and procedures outlined in this Manual shall be considered to be subject to change. The Duke University Radiation Safety Officer will transmit new policy information to the Authorized Users by posting material to the OESO Web site, via electronic mail or via campus mail as soon as it is approved by the Committees.

Although the safe use of lasers and other forms of non-ionizing radiation is an area of oversight by the Committees, complete coverage of these areas will be provided in separate documents. Specific information on the organization, policies, procedures and training programs of the Laser Safety Program may be obtained by contacting the Radiation Safety Division.

  1. ORGANIZATION OF RADIATION SAFETY PROGRAMS AT DUKE UNIVERSITY

    2. The organization of the Radiation Safety Program at Duke University reflects the intent of North Carolina State and Federal laws regarding the administration of radiation protection programs.

    The Administration of Duke University appoints two Radiation Safety Committees, one to provide radiation protection oversight to the Medical Center and Medical School, and another to the University. The Duke Radiation Safety Officer reports to both Committees. The policies of the Committees are executed by the Radiation Safety Officer through the Radiation Safety Division, which, along with Biological Safety, Occupational Safety and Hygiene, Environmental Programs, Ergonomics, and Fire Safety, is a component of the Duke University Occupational and Environmental Safety Office (OESO). The Radiation Safety Division, in turn, provides guidance and oversight to all Authorized Users of radiation producing devices and radioactive material on campus, in the Medical Center, in the Medical School, at the specific accelerator facilities, and at Duke University affiliated medical facilities. In addition, the Radiation Safety Division provides support to the Radioactive Material Waste Program and provides oversight for the Laser Safety Program. To such an extent as required by inter-institutional agreements or North Carolina Regulations for Protection Against Radiation, the Radiation Safety Committees and the Radiation Safety Division will provide guidance and oversight to the Radiation Safety programs of those components of the Duke University Health System which employ radiation-producing machines and/or utilize radioactive material.

    1. Administration -- The Duke University/Medical Center administration works through the Committees and the Radiation Safety Officer to provide institutional oversight of radiation safety programs.
    2. Committees -- The Duke University Committee on Radiological Safety, the Duke University Medical Center Radiation Control and Radioactive Drug Research Committee, and the Accelerator Radiation Safety Committees are responsible for establishing and enforcing policies and procedures for the procurement, use and disposal of radioactive material, devices emitting non-ionizing and ionizing radiation, and lasers.
    3. Radiation Safety Officer -- The Radiation Safety Officer is the on-the-job representative of the University and Medical Center Committees for providing information and assistance on radiation safety matters and to assure adherence to regulations issued by the Committees and State or Federal agencies.
    4. Accelerator Director -- provides administrative support to a specific campus accelerator facility.
    5. Radiation Safety Manager -- provides local radiation safety support to a specific campus accelerator facility.
    6. Authorized User -- Any person authorized by the University or Medical Center Committee to use or supervise the use of radioactive material and/or devices producing ionizing or non-ionizing radiation.
    7. Radiation Worker -- A person utilizing ionizing radiation under the supervision of an Authorized User.

  2. THE PRINCIPLE OF "ALARA"

    3. Every employee of Duke University and its affiliated institutions is protected from unnecessary exposure to ionizing radiation by Federal and State law. Accordingly, every Duke employee is empowered to minimize his or her radiation exposure by being (a) advised of their recorded radiation exposure in relation to regulatory limits, and (b) informed about protective practices that can reduce exposure through education and training.

    The United States Nuclear Regulatory Commission and the Radiation Protection Act of the State of North Carolina define "maximum permissible dose limits" for individuals who are exposed to radioactive material or radiation sources during the course of their employment. These limits, which have been recommended to the Nuclear Regulatory Commission by various government and private advisory organizations, are believed to represent exposure levels that should not result in harm to the worker or his / her offspring during their lifetime.

    In view of the uncertainty of the effects of low level radiation exposure, it appears prudent to keep all radiation exposures and releases of radioactive material to the environment to the lowest possible levels. This is the philosophy underlying the phrase "As Low As Reasonably Achievable", or ALARA. This concept is incorporated in the regulations by requiring that all environmental releases and personnel doses be in accordance with ALARA, and not simply meeting published regulatory limits. A program fully complying with ALARA will be within or below 10% of such limits.

    "Occupational dose" refers to the radiation dose received by an individual in a restricted area or in the course of employment in which the individual's assigned duties involve exposure to radiation or licensed radioactive material, whether in the possession of the licensee or registrant or other person. Occupational dose does not include the dose received from background radiation, as a patient from medical procedures, from voluntary participation in medical research programs, or as a member of the general public.

    Table 1 lists the maximum permissible doses to personnel from ionizing radiation, as described in 15A NCAC 11. A column identifying current Duke University ALARA action levels has also been included for reference purposes.

Table 1. Permissible Occupational and ALARA Doses

Body Part Exposed Permissible Dose (Rem/Year) Duke ALARA goal (Rem/Calendar Quarter)
Whole body (head, trunk, gonads, arms above elbows, legs above knees) 5.0 0.125
Lens of the eye 15.0 0.375
Single Organ 50.0 1.25
Hands and forearms, ankles and feet 50.0 1.25
Skin of whole body 50.0 1.25
Embryo/Fetus (see Note below) 0.5 rem during gestational period 0.5 rem during gestational period

Note on Fetal Radiation Dose: Fetal radiation dose is determined by appropriate monitoring of the pregnant woman. It is recommended that all women who work with radioactive material, participate in the care of patients who are being treated with radionuclides, or who work in proximity to radiation-producing devices, declare their pregnancy (see Chapter VI, Reproductive Health Policy) in order to obtain appropriate monitoring and counseling.

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