The culture of radiation therapy may be changing, but neither the American Society for Radiation Oncology (ASTRO) nor the U.S. Nuclear Regulatory Commission (NRC), the primary federal agency responsible for regulating many technologies used in radiation therapy, is interested in creating a punitive environment for radiation oncologists. Rather, the two entities hope to partner with practitioners to create a culture of safety that will benefit patients and providers alike.
Such was the message delivered by ASTRO President Anthony Zietman, MD, a radiation oncologist at Massachusetts General Hospital in Boston, Massachusetts and professor at Harvard Medical School; and NRC Chairman Gregory Jaczko, PhD, during a joint session held today at ASTRO’s Annual Meeting in Miami Beach, Florida.
Zietman notes that while radiation oncologists could once practice their specialty unfettered, rhe 21st century is a new age of transparency and accountability. It can no longer be presumed, he says, that radiation oncologists are thoroughly knowledgeable about treatments for cancer, and that a radiation oncology department will always practice safe medicine.
He adds that part of the challenge of radiation therapy is the lack of evidence-based guidelines for best-practice radiation safety procedures. "Safe decision-making is a tricky thing, especially when there is insufficient evidence," Zietman asserts. Another complicating factor is the variance in cancer treatments throughout North America and, in fact, the world.
ASTRO has been working for several years to establish a culture of safety, purports Zietman, noting that it is promoting accreditation among its members and is running an education program focused on safety. The society's work in developing the Integrating the Healthcare Enterprise - Radiation Oncology (IHE-RO) profile has merited the attention of the U.S. Food and Drug Administration (FDA), he adds.
Meanwhile, Jaczko says, "With respect to overseeing the use of nuclear material for clinical applications, the goal of the NRC is the same as radiation oncologists: to protect patients receiving radiation therapy treatments and the caregivers who administer them.” The challenge NRC has as a regulatory agency is to maintain responsibility for appropriate use of radiation, but without impeding medical progress, he observes.
NRC has established a framework of oversight with a foundation of voluntary reporting. While nuclear power plants are inspected regularly, Jaczko points out, NRC regulators rarely visit medical facilities, in large part because such an option is not feasible.
"Our approach gives you the space to practice medicine," he explains. "We are not interested in how you practice medicine. Our primary focus is ensuring that medical professionals are properly trained to know how to use radiation safely, in accordance with the NRC's rules and regulations.
"When you report a medical event, it is your responsibility to explain what happened, if and how a patient was affected, and what you are going to do to prevent this incident from happening again. We are not interested in knowing what radiation dose you prescribed and if it was within recommended guidelines, but rather if the total dose differed by 20% or more from what you prescribed when it was administered to a patient."
Jaczko adds that a report on a medical event does not automatically equate to a violation of NRC requirements, which really occurs when NRC sends a letter to the practitioner. The commission is currently updating some of its definitions, but will not eliminate the requirement to report a medical event.
Moreover, language is being modified for rules related to a trained user of radiation attesting to the ability of another individual. Current language is of concern to potential attesters – specifically, that they could become personally liable for another individual's actions.
Jaczko claims ASTRO's collaboration with NRC in working on these initiatives was a winning situation for all concerned. Dispelling perceptions that NRC and ASTRO are adversaries, he says, "We've got the same goal and we are working together to achieve it: to have a universal culture of safety in every medical facility where radiotherapy treatments are administered.”