MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections.

UNLABELLED: The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc).This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility.

LEARNING OBJECTIVES: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips)1.Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo).2.Understand the AU approval process for microspheres and Xofigo.3.Examine the training and handling requirements for new procedures.4.Understand the process involved with protocol development, SOP in order to define roles and responsibilities.The RSO and The RSC: Challenges and Opportunities (Colin Dimock)1.Understand how to form an effective Committee.2.Examine what the Committee does for the Program and the RSO.3.Understand the importance of Committee engagement.4.Discuss the balance of the complimentary roles of the RSO and the Committee.The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger)1.Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology.2.Examine 10CFR35 requirements as they relate to the everyday practice of Nuclear Medicine and Radiation Oncology.3.Understand the nature of available guidance documents (e.g., NUREG 1556).4.Examine the commonalities between TJC and CMS preparedness.