The radiation safety officer (RSO) is an essential part of the functioning of a medical facility. However, we often find that clients and prospective clients lack a true understanding of the scope, responsibilities, and best practices related to the position.
A medical facility must have a competent and engaged RSO on staff to help protect against regulatory scrutiny and liability. Fines of $100,000 and up have been levied against medical facilities for failures in radiation safety, and lawsuits can have a devastating effect on the business and morale of a medical facility. Most importantly, an RSO plays a critical role in protecting patients and staff from harm.
A radiation safety program at a medical facility led by an RSO is governed by hundreds of regulatory requirements at the state and federal levels; the goal of this post is to articulate the essence of those disparate regulations and requirements in an easier-to-read form.
PART 1: Radiation Safety Officer 101
Question 1: Am I required to have an RSO at my medical facility?
Medical facilities are required to obtain a license from the US Nuclear Regulatory Commission (NRC) when “intentionally administering byproduct material or radiation from byproduct material” (i.e., administering radioactive materials) to patients or human research subjects. This generally includes facilities using radioactive materials for treatment or diagnostic purposes. According to 10 CFR 35.24, “A licensee’s management shall appoint a Radiation Safety Officer who agrees, in writing, to be responsible for implementing the radiation protection program.”
Question 2: What are the regulations that govern RSOs and radiation safety programs?
There are numerous NRC regulations governing radiation safety, licenses, and medical use of radioactive materials (see, e.g., 10 CFR 19, 10 CFR 20, and 10 CFR 35), in addition to separate state or other governing body regulations (e.g., VHA/NHPP) all covering the scope, duties, and responsibilities of the RSO in a medical facility. Other guidance documents, like NUREG-1556. Vol 9, offer additional guidance on materials licenses for medical use.
Question 3: What role does the RSO play in the administration of radioactive materials to patients in a medical facility?
Under NRC regulations, administration of radioactive materials must be overseen by an “authorized user.” An authorized user is a physician, dentist, or podiatrist who meets certain training and experience requirements of the NRC or an Agreement State license, which is most often a board certification. As the point person in charge of the safe use, handling, and storage of radioactive materials, the RSO plays a key role in enabling authorized users to fulfill their duties in ensuring the appropriate use of said radioactive materials. Broadly speaking, an RSO is responsible for identifying radiation safety problems; initiating, recommending, or providing corrective actions; stopping unsafe operations; and verifying implementation of corrective actions.
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