UCLA Procedure 994.1 : Radiation-Producing Equipment
I. BACKGROUND & SCOPE
UCLA Policy 994 sets forth responsibilities of specific campus officials and committees in order to ensure compliance with all applicable laws and regulations overseeing the safe use of radiation. The UCLA Clinical Operations Radiation Safety Committee (CORSC), designated by the Vice Chancellor for Research, oversees radiological procedures in all clinical operations at UCLA. In consultation with the Radiation Safety Office (RSO) and the Office of the Radiation Safety Committees (ORSC), CORSC oversees all radiation-producing equipment use and related inspections.
This Procedure sets forth the required designation of a Responsible User (RU) for radiation-producing equipment and the proper management of such equipment.
This Procedure applies to all UCLA departments and units, whether on- or off-campus, using radiation-producing equipment.
Radiation-producing equipment at UCLA or any UCLA-operated medical facility or clinic, whether purchased, loaned, donated or provided under a research agreement, shall be under the control of a designated Responsible User (RU).
The responsible department or unit shall identify the RU at the time the equipment is registered with the ORSC. If an individual is not specified, the Department Chair or Division Chief will be listed as the RU. Through coordination with the CORSC and the RSO, departments and units shall report all designated RUs within their respective areas to the CORSC on an annual basis.
The RU is responsible for managing all radiation-producing equipment under their control in accordance with the procedures set out below. For specific definitions and guidance regarding RU responsibilities see the CORSC Radiation-Producing Machine Guidance.
To ensure compliance with applicable federal and State laws and regulations, and to maintain a healthy and safe working environment, the RU and their supervising department/unit shall adhere to the procedures below.
A. Inventory and Registration of Radiation-Producing Equipment
All radiation-producing equipment acquired for greater than 30 calendar days must be properly inventoried and registered with the California Department of Public Health (CDPH).
The RU must notify the RSO, in coordination with the Qualified Medical Physicist (QMP) as applicable, of all acquired, transferred, or recently disposed radiation-producing equipment in their respective areas. The RSO is responsible for ensuring the registration of radiation-producing equipment with the CDPH.
Prior to patient use and in coordination with the appropriate hospital and university entities, the designated RU must ensure proper registration and acceptance testing , including safety and performance verifications of all radiation-producing equipment in a clinical area, regardless of whether the equipment is purchased, loaned, donated, or under research agreement.
B. Maintenance and Calibration of Radiation-Producing Machines
The RU and supervising department /unit ensures that equipment is inspected, calibrated, and maintained and is compliant with State, federal, and local regulations and manufacturer and accreditation requirements. Additionally, the RU and supervising department/unit ensures that equipment service requests and repairs are initiated and completed in a timely manner through coordination with appropriate manufacturers, vendors, and Clinical Engineering.
Written quality assurance programs ensuring compliance with these requirements must be implemented and made available for review.
Documentation shall be maintained for a minimum of three years and records must be available for review for regulatory or accreditation inspections or other University oversight purposes.
C. Regulatory and Accreditation Inspections of Radiation-Producing Machines
The RU or supervising department shall notify the RSO, Clinical Engineering, and QMP of any federal, State, or local regulatory or accreditation inspection requests. Coordination of inspections shall be performed by the RU and supervising department/unit to ensure requisite personnel and radiation-producing equipment availability.
Inspection results will be reported to the responsible departments and committees, as determined by the RSO, Clinical Engineering, QMP, and/or License Accreditation & Policy Department and upon request, as appropriate. Any identified violations or recommendations will be discussed between the aforementioned groups and corrective actions will be implemented, as appropriate.
UCLA Policy 994, Radiation Safety;
UCLA CORSC Policy: Clinical Use of Radiation-Producing Machines Used in the Healing Arts;
California Code of Regulations Title 17, Subchapter 4.5, Group 5: Certification of Licentiates;
Office of Radiation Safety Committees (ORSC) Website;
UCLA Radiation Safety Website.
/s/ Economou, James
Vice Chancellor - Research