For the University of Kentucky, a robust Radiation Protection Program is fundamental to ensuring the safe operation of radiation generating devices (RGDs) and other radiation-producing equipment. This program aims to minimize potential health risks to faculty, staff, students, and the general public, while strictly adhering to federal, state, and institutional regulations.
The core principle guiding the University of Kentucky's Radiation Protection Program is to maintain radiation exposures As Low As Reasonably Achievable (ALARA). This means making every reasonable effort to keep exposures to ionizing radiation far below established dose limits, considering technology, economics, and societal factors. This philosophy applies to all individuals and activities involving radiation generating devices (RGDs) within the University.
The use of radiation generating equipment at the University of Kentucky is governed by a multi-layered regulatory system:
• Federal Regulations: The Food and Drug Administration (FDA) sets performance standards for cabinet X-ray systems under 21 CFR 1020.40. Manufacturers of such systems must certify compliance with these federal standards.
• State Regulations: Most U.S. states, including Kentucky, regulate X-ray producing machines. These state regulations often require registration, inspections, and adherence to specific operational. For Kentucky, registration is required within 10 days of installation, and annual inspections are typically performed.
• University Policies: The University of Kentucky, through its Environmental Health and Safety (EH&S) department and a designated Radiation Safety Committee (RSC), establishes internal policies and procedures that ensure compliance with external regulations and often implement stricter internal ALARA goals. All radiation generating devices (RGDs) must be authorized by the University's Radiation Safety Office before use.
A comprehensive program at the University of Kentucky includes:
◦ All analytical X-ray producing equipment must be registered with Kentucky Cabinet for Health and Family Services. This must be done within 10 days of installation. Use this Form to submit registration to the Radiation Safety Office.
◦ Prior to acquiring, purchasing, moving, transferring, or disposing of analytical X-ray equipment, the Principal Investigator (PI) must notify the Radiation Safety Officer (RSO).
◦ Internal authorization (often called a "Permit" or "Machine Use Authorization") from the University's RSC and RSO is required for all radiation generating devices (RGDs). Each Permit specifies the Permit Holder, use restrictions, and approved operators.
◦ The Radiation Safety Committee (RSC) is the governing body for all aspects of radiation safety, establishing policies, approving proposals for radiation generating devices (RGD) use, and ensuring ALARA compliance. The RSC has the authority to grant, deny, or withdraw permission for radiation source use.
◦ The Radiation Safety Officer (RSO) is responsible for the day-to-day management of the program, ensuring compliance, developing procedures, providing expertise, conducting audits, and serving as the primary contact for all radiation safety matters. The RSO has the authority to halt operations if unsafe conditions exist.
◦ Mandatory training is required for all personnel operating X-ray equipment at the University of Kentucky.
◦ This includes initial X-ray safety training provided by the Radiation Safety Office and hands-on equipment-specific training provided by the PI or X-ray supervisor,
◦ Training covers radiation hazards, safe operating procedures, warning devices, emergency protocols, and ALARA principles.
◦ Written, device-specific operating and emergency procedures are required for each radiation generating device (RGD) and must be readily available to all users.
◦ These SOPs must provide instructions for sample handling, equipment alignment, routine maintenance, data recording related to safety, and emergency contacts.
◦ No individual is permitted to operate equipment in any manner other than specified in the procedures without RSO approval.
◦ Regular radiation surveys are conducted upon installation and annually during inventory accounting.
◦ Surveys are also required after modifications, maintenance involving disassembly of components, or if an abnormal condition is observed.
◦ These surveys ensure radiation levels remain within safe limits (e.g., 0.5 mR in one hour at 5 cm outside the external surface for cabinet systems).
◦ Dosimeters (e.g., whole body badges, finger rings) are provided to individuals who may receive a significant radiation dose, or for open-beam and hand held applications (handheld XRF), to monitor and record their exposure.
◦ Dosimetry is exchanged periodically (quarterly) and results are reviewed by the RSO.
◦ Declared Pregnant Workers: Special provisions and lower dose limits (e.g., 500 mrem for the gestation period, 50 mrem per month recommended) apply to declared pregnant workers who voluntarily inform the RSO in writing.
◦ X-ray systems and operating areas must be clearly marked with warning signs such as "CAUTION – X-RAY EQUIPMENT" (with the radiation symbol) posted outside each area or room.
◦ Labels like "CAUTION – HIGH INTENSITY X-RAY BEAM" must be on the X-ray source housing.
◦ Labels such as "CAUTION RADIATION – THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED" should be near any switch energizing the X-ray tube.
◦ Fail-safe warning lights labeled "X-RAY ON" (or similar intent) must indicate when X-rays are being generated, visible from initiation points, doors, access panels, and ports.
◦ For ports, a label stating "CAUTION: Do Not Insert Any Part of the Body When System is Energized—X-ray Hazard" is required.
◦ Devices intended to prevent X-radiation generation when access to the interior of a cabinet X-ray system (through doors or access panels) is possible.
◦ Cabinet X-ray system doors require a minimum of two safety interlocks, one of which must physically disconnect the energy supply to the high-voltage generator. Access panels require at least one interlock.
◦ Bypassing interlocks is strictly prohibited unless under approved written procedures and with RSO authorization for a specified period, and a "SAFETY DEVICE NOT WORKING" sign must be posted.
◦ Comprehensive records must be maintained, including equipment inventory, use logs, maintenance records, training documentation, and radiation survey reports.
◦ Records of accidental radiation occurrences (AROs) and non-compliance are mandatory for manufacturers and users.
◦ Clear emergency procedures must be in place and posted, outlining steps in case of suspected exposure, equipment malfunction, fire, or other incidents.
◦ Immediate notification to the RSO and seeking medical attention for exposed personnel are critical first steps.
◦ Bears primary responsibility for regulatory compliance and radiological safety within their work group.
◦ Supervises users, ensures adherence to Permit conditions and SOPs, and controls the lifecycle (acquisition, transfer, disposal) of radiation generating devices (RGDs).
◦ Responsible for maintaining an up-to-date list of personnel, ensuring training, managing dosimetry, and maintaining an operating log.
◦ Oversees the entire Radiation Protection Program, develops procedures, provides training, conducts audits and surveys, manages device registration and inventory, responds to emergencies, and acts as the regulatory liaison.
◦ Must comply with the University's X-ray Safety Manual, laboratory SOPs, and all applicable regulations.
◦ Required to attend training, use assigned dosimetry, and immediately report any unsafe conditions, equipment malfunctions, or suspected exposures.
◦ Responsible for knowing and practicing ALARA principles to minimize exposures.
By upholding these principles and responsibilities, the University of Kentucky can ensure a safe working and learning environment for all individuals associated with radiation generating equipment.