Radiology has been something like a trapeze artist performing without a net. The perfected feats can be spectacular to behold, but a slip of a grip and the result can be tragic. Adam Dicker, MD, PhD, Professor and Chair of the Department of Radiation Oncology at Sidney Kimmel Medical College, and Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, doesn’t mince words. “In the world of radiation oncology, there have been some terrible—horrific—events that have occurred in the past. I recall hearing of a patient who was supposed to get a particular dose of radiation but actually got three times that dose,” he said austerely.
He added that, while these things don’t happen often, they happen. “Sometimes it is human error, but it could also be attributed to how the equipment communicates with the computer that is controlling it,” he told OT.
Mum’s the Word
Medical errors in the field of radiation oncology have plenty of portals to sneak through. Errors occur at various steps in treatment, from planning the radiation oncology to delivering the radiation dose. Dicker said it is a certainty that things have happened at every step—at some time and some place.
“Imagine this scenario,” Dicker entreated. “Something faulty happens at Facility XYZ, and the team there realizes that between the software vendor and the hardware vendor there is a particular flaw that could lead to the potential for patients to get the wrong treatment. The XYZ Team uncovered the problem and should tell the world. But to whom, exactly, would they communicate that?”
There’s no easy answer, said Dicker, because there are more than 20 federal-level agencies involved with such a situation. “It’s not just a simple call to the FDA,” he lamented. “And even if the XYZ Team told the vendors of the malfunction, each would point the finger at the other. It’s human nature.”
A Solution Is Found
Literature teaches that one of the best strategies for reducing patient harm throughout healthcare is the identification and learning from errors through large-scale reporting systems. In hopes of applying this dictum to radiation oncology, the Radiation Oncology Incident Learning System (RO-ILS) was established in 2011, then launched in 2014 through the efforts of the American Society for Therapeutic Radiology and Oncology (ASTRO) and the American Association of Physicists in Medicine (AAPM) working with Clarity Patient Safety Organization (PSO), a federally listed patient safety organization with the Agency for Healthcare Research and Quality (AHRQ). Dicker is one of the authors of an article, “ROI-ILS: Radiation Oncology Incident Learning System: A report from the first year of experience” (Practical Radiation Oncology 2015;5:312-318).
“About six years ago, we in the industry agreed that we needed to do something,” Dicker explained. “There is a federal statute through AHRQ that allows for the creation of PSOs—protected federal spaces, ranging from a single hospital-based PSO to a statewide PSO.” When ASTRO conducted a membership survey in 2011, it found that 85 percent of radiation oncologists and 94 percent of medical physicists reported they would use a confidential reporting system for medical errors and near misses if one were available.
Enter RO-ILS, a radiation oncology-specific PSO that was developed and is administered, under contract with ASTRO and AAPM, by Clarity PSO. Federal regulations dictate there must also be a formal and contractual agreement between the PSO and the radiation oncologists who choose to participate in this voluntary endeavor.
Using an electronic, web-based tool accessible in the practice setting, “participants can submit data through a SafetyZone Portal,” said Dicker, “for misadministration errors, near misses, good catches, whatever the situation and the data may be. But here’s why it’s a game-changer: They can submit it and it is free from any investigation by malpractice attorneys (with the exception of cases of criminal negligence). We’re seeing facilities, healthcare systems, private practices, community practices, and academic institutions volunteering to participate. Every month, they upload things that occurred that may or may not have caused harm—it doesn’t make a difference. Everyone, de-identified, is sharing in what is going on.”
Dicker serves on the national advisory board of RO-ILS. “There is a group of us—physicians, physicists, dosimetrists, therapists, and PSO experts interested in quality analysis—who go over reports, try to make sense of the data, and try to connect the dots if there are dots to be connected.”
Within the first year after launch, 79 institutions had signed contracts or contracts pending with the PSO (now there are more than 100), and in that short time 739 patient safety events had been entered into local databases. Of those, according to the paper co-authored by Dicker, 48 percent were shared out on the national database for analysis by the Radiation Oncology Healthcare Advisory Council (RO-HAC). The article further noted data revealed “… the treatment planning and pretreatment review/verification workflow steps were consistently the most commonly identified points at which an error occurred (33% of events) …”
Dicker commented, “Just by having a mechanism by which people can report these types of events, it sensitizes a facility to become more open and aware; it empowers at every level of the organization, whether a person is a radiation therapist, physicist, dosimetrist, physician, nurse—it doesn’t matter. Everyone is empowered to report.”
Participants are making sincere efforts to improve quality and safety, said Dicker, adding that there is no sense of mean-spirited tattling involved. “It is no different than on a hospital floor where nurses are empowered to report if a doctor failed to wash his hands,” he said. “If all of us want to make radiation oncology better, there can be no fear of recrimination. Everyone has something to contribute and everyone must have a voice at the table.”
As if this hypothetical situation were not sticky enough already, it’s about to get sucked into an additional syrupy muck. “Let us assume that Facility XYZ did everything absolutely right, but because of this faulty software/hardware issue a patient was harmed,” continued Dicker. “Now they’re looking at a malpractice suit. And guess what? This crack team that discovered the problem can’t say a word because they may be defending a lawsuit. Their hands are tied; they can’t volunteer information and let other people in the radiation oncology community know about it. And they really need to know about it.”
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