By Suzanne Evans, MD and Sheri Weintraub, PhD
RO-ILS: Radiation Oncology Incident Learning System® releases regular reports and education to the radiation oncology community based on safety events and errors submitted by participating U.S. practices. Aggregate data trends held steady over the past eight years, with expected fluctuations associated with data element changes (e.g., when a data element became required, new answer options were added). That was, until now. The RO-ILS Q4 2021 Aggregate Data Report indicates a striking new trend in 2021 related to the workflow step in which events occurred.
Between 2017 and 2020, when data element 208. Occurred Workflow was required, event occurrence during treatment delivery (including imaging) has traditionally comprised an average of 26% (Figure 1). However, for 2021 that number was 41%. This represents a 58% increase over historical norms. Fewer events were seen to occur in treatment planning and pre-treatment quality assurance (QA) and review, whereas other domains remained stable relative to historical norms.
Unsurprisingly, the downstream metric for where the event was discovered (207. Discovered_Workflow) similarly shifted to the right, with 29% of events discovered at on-treatment QA compared to a historical average of 11% (Figure 2).
Why are we seeing this change in RO-ILS data? Did more events actually occur at the linear accelerator (linac) and if so, why? Did fewer errors happen during treatment planning and why might that be the case? Or are there other factors that impact the data?
It is important to understand there are two basic interpretations of this finding: that this is real, or that this is artifactual. Perhaps there really is a shift in where in the workflow errors occurred in 2021 (e.g., more events happened at treatment delivery). Conversely, it could be artifactual — that the events occurring at treatment delivery are stagnant in number, but that we are seeing a relative percentage increase in these events due to selective non-reporting of more upstream events, a risk of any voluntary incident reporting program. Although more analysis is needed, we have some initial thoughts as members of the Radiation Oncology Healthcare Advisory Council (RO-HAC) who review and analyze RO-ILS data.
First, let's consider interpretation 1: More events are happening at treatment delivery, fewer events at other workflow steps. This real trend could either be a positive or negative indicator of safety.
Let’s be optimistic and consider that this is a real trend and is actually a good thing. Perhaps advancement in technology may explain this phenomenon. For example, with the rise of new equipment like surface guided radiation therapy (SGRT), practices may be better able to detect errors occurring during treatment that were otherwise opaque before. SGRT can be very helpful in detecting the improper application of shifts, which has been demonstrated in the RO-ILS data to be a major pathway of significant errors. Additionally, there has been a move toward increased automation of treatment planning processes, which may result in a reduction in errors occurring earlier in the process of care. If enough practices acquired or implemented SGRT and/or knowledge-based planning tools between 2020 and 2021, then this could result in a shift in where in the process events are occurring.
How about the impact of the pandemic? That has certainly brought about a dramatic shift in a short period of time. COVID-19 affected the ability of certain staff members to work from home initially, which then brought on a wave of employees seeking work from home or hybrid arrangements as part of routine practice. As treatment planning can be done remotely, this may have altered the work environment for dosimetrists more than for other members of the radiation oncology team. Are at-home work environments for dosimetrists conducive to higher safety standards, leading to fewer errors in treatment planning?
Importantly, incident learning systems, including RO-ILS, encourage reporting. More events can indicate heightened awareness within that process of care, a strong culture of safety and the desire to address issues, no matter how trivial. Technology advancements such as adaptive radiation therapy are increasing the complexity of treatment delivery. With the adoption of new systems, an increase of events is expected as practices work to perfect processes. More events within a given process could result in an increased detection of errors that otherwise would have been hidden or unknown.
Now, let us consider that this trend is real, but that it’s actually a bad thing. Multiple waves of COVID-19 in 2021 left many practices with significant numbers of staff out at one time for various reasons (e.g., personal, family illness, quarantine). This lack could have resulted in temporary deviations in the staffing policies of two radiation therapists per linac or fewer on-site physician or physics staff available to draw upon for guidance with a challenging setup. COVID-19 had a heightened impact on radiation therapists, as they were required to continuously support treatment delivery on site, while other professional roles may have been able to limit their public and workplace exposures for at least some portion of time. The compounded stress may have impacted performance, team relations and the work environment. This could result in COVID-19’s influence on safety being greater in the treatment delivery space than in the treatment planning space.
Now, let's consider interpretation 2: The number of events happening at treatment delivery is stable, but there are other confounding factors that skew the data.
In the United States, incident learning is voluntary, a crux of the legal protections afforded by the Patient Safety and Quality Improvement Act of 2005 and through participation in patient safety organizations (PSO). Estimates are that voluntary reporting only accounts for approximately 10% of the events that actually occur. Therefore, we must be careful when analyzing the data to ensure we appreciate this limitation. If PSO protections were not present, we would see even fewer of the events that occur, so it is essential that the anonymous, confidential work of the PSO remains supported.
One can imagine that the radiation oncology workforce is tired. With so many constraints on their time, in the second year of the pandemic, incident learning may have become a lower priority. RO-ILS recommends reporting any error that passes through the first checkpoint, regardless of whether it reaches the patient or is caught further downstream at a later safety check. However, we know not all practices are able to do this and that not all staff work in a culture of safety that supports this.
Although the number of events reported to RO-ILS has been fairly stable, the incident learning system has been functioning in an environment with staffing shortages, disrupted processes and individuals dealing with the mental task load of the pandemic. It is plausible that events occurring during treatment planning and on-treatment QA, which can be caught by normal QA, are deemed less of a priority to report than events happening at the linac. Therefore, with an underreporting of treatment planning and on-treatment QA occurring events, the relative percentage of events occurring at the linac would appear to rise.
In addition to practice-specific reporting thresholds, it is possible that changes in reporting patterns among RO-ILS enrolled practices have impacted the overall national trends. The extent to which some practices are reporting to the PSO cannot be ruled out as a cause of this trend.
What do you think? Which interpretation is more plausible to you? Importantly, are you seeing the same trends in your local practice’s incident learning data? As an individual practice, with knowledge of your practice-specific circumstances (e.g., staff, technology advancements, culture) the meaning of incident learning trends can be better postulated.
With support from the PSO, RO-HAC will dig deeper into the RO-ILS data to try to better understand possible contributing factors to this national trend. In the meantime, why do you think we are seeing this shift in the national data? Please comment below with your observations and thoughts.
This article was originally published in the American Association for Physicists in Medicine (AAPM) March/April newsletter.
By Eric Ford, PhD, FASTRO, Sue Evans, MD, MPH, and Jean Wright, MD
Patient Safety Awareness Week (PSAW) began in 2002 as annual event intended to encourage a continued focus on health care safety. This year it is observed March 13-19 and serves as a national education campaign for promoting patient safety practices. We know that quality and safety are priorities for medical physicists every day, and this week is an opportunity to increase awareness within your practice.
Patient safety was at the center of most radiation oncology discussions after the 2010 New York Times article, and tremendous progress has been achieved since that time. However, much like quality, safety assessments and improvements are an ongoing exercise. In the wake of the 2010 events, the American Society for Radiation Oncology (ASTRO) and the American Association of Physicists in Medicine (AAPM) collaborated to develop a national radiation oncology incident learning system (ILS), RO-ILS, to facilitate safer and higher quality care in a secure and non-punitive environment. In 2014, using the guidance in Safety is No Accident, ASTRO created its own radiation oncology-specific practice accreditation program. ASTRO’s APEx - Accreditation Program for Excellence® builds on consensus statements, AAPM Task Group reports and technical standards to support safety and quality.
Medical physicist, Eric Ford, PhD, FASTRO, from University of Washington, Seattle, along with radiation oncologists, Sue Evans, MD, Yale School of Medicine, and Jean Wright, MD, Johns Hopkins Medicine, are well known contributors to the topic of quality and safety within radiation oncology. In light of the upcoming PSAW, these leaders recently discussed quality and safety initiatives that resonate with them, including incident learning, accreditation and the importance of safety culture.
Eric: Let’s start off by talking about one of my areas of focus, ILSs. Active engagement in programs such as RO-ILS can directly benefit our patients, and everyone has a role to play.
Sue: Certainly, and there is a central and pivotal role that medical physicists play in supporting quality improvement, especially in incident learning. I believe that if a physicist is not advocating for and engaging with an ILS, it will simply fail. We need the thoughtful analysis from the physics perspective to make our systems stronger and there’s nobody else better suited to speak to all the processes involved in an incident.
Eric: I know I feel that way, but it’s so important to hear those kinds of affirmations from our colleagues.
Sue: I’m reminded how the late Peter Dunscombe used to quibble and call it an incident teaching system, because he would say that the learning is up to you. Those of us in radiation oncology know the same sorts of incidents keep happening and sometimes they fail in new and exciting ways, and sometimes they fail in the same old boring ways. Having data in a national system enables us to explore this further, identify trends and work with community partners, such as vendors, to resolve some of these error pathways. Varian and Sun Nuclear Corporation have been long standing supporters of RO-ILS and hopefully other vendors will join the effort.
Eric: The practice culture underpins everything that happens, and PSAW presents an opportunity to improve it. How does RO-ILS support safety culture?
Sue: One of my favorite ways is creating a safe space to talk about errors. It’s easier to discuss an error that occurred somewhere else, so practices can start with RO-ILS education and then analyze the data in their local RO-ILS system. It is helpful to not feel alone; to know that on the national level, they might be seeing the same thing that happened at your practice. I do think it's a way to normalize errors and to allow people to be more open about it and foster safety culture from that aspect. In 2021, RO-ILS added safety check questions in the educational resources to encourage more active reading, reflection and spark conversations.
Jean: Incident learning is a forward-thinking approach. Rather than focusing on what happened to assign blame, we must investigate the contributing factors and understand why the error occurred. This allows us to appreciate how errors happen and then work to address it, so it doesn’t happen again. I think all the resources that come with RO-ILS really convey that message and make it easy. You can have a discussion and go over the errors as a group.
We [Johns Hopkins Medicine Department of Radiation Oncology] are in the process of transitioning fully to RO-ILS. One of the reasons we wanted to change from our internal program is that the participation at the national level is more impactful and gives us the ability to learn from others and provide more information back to the community in a safe, protected way. But we’ve known that for a long time. To be honest, I'd say the biggest driver for us is the ability to do the analytics in a way that's more ready-made. Once you learn the features of RO-ILS, you realize that it has options to tailor reports.
Eric: Accreditation is another initiative that gives practices an opportunity to review their specific reports, promote safety and should be celebrated for PSAW.
Sue: I think we all understand that the same basic processes happen in each radiation oncology practice, regardless of our vendor equipment and our individual workflows. In our APEx assessment, we found areas that required more standardization and where we could beef up our processes. I know when we went through APEx, it was amazing how many processes that we thought were buttoned up well, but in reality hadn't been revised in three or four years. Also, it showed us where we didn’t have a defined process.
Jean: Another thing I want to highlight about APEx is that there are two phases — this is the crux of the program. It has the self-assessment phase and then the site visit. The self-assessment phase consists of an initial review where practices conduct an internal assessment of their own medical records policies, procedures and other forms of documentation. As a result, you have the opportunity to identify areas that you may want to improve on prior to the site visit like Sue just talked about, where they didn't even know there was a problem. That definitely happens with APEx. The self-assessment helps you realize you don't have something in place.
Eric: Jean, how are the physics elements assessed in APEx?
Jean: The APEx medical record review is fairly equally weighted between physician medical notes and physics documentation that supports quality assurance (QA) for patient safety. Another substantial component of the program is the document review. APEx assesses individual specifications for machines like commissioning documentation, results of annual and monthly testing, and all the different QA checks are done at the machine level. It's really a physics-driven process in a lot of ways.
Sue: The other thing that I'll add to that, Jean, is from my understanding of having friends at other institutions going through this process, they've actually found the accreditation process to be very helpful when they're in discussions with their hospital or funding source because sometimes you'll have an accreditation notation and say the QA process you have for this modality is certainly adequate, but it’s recommended that you look at adding an aspect that requires new equipment acquisition. A lot of organizations that I know have been able to successfully lobby their hospital or parent institution and say APEx told us that we were OK, but if we really want to be excellent, we need to add something. The institution or organization will really listen to that. Accreditation helps advocate for you in terms of really elevating your game.
Eric: I’ve witnessed this as well. Accreditation can be an ally for physicists.
Jean: The APEx Standards are very clearly delineated so practices know what is going to be evaluated and there is no mystery. Because of the Self-Assessment, you’ll have a very clear sense of how you will do even before the surveyors arrive.
Eric: I agree. In reviewing the APEx Standards, I think the requirements should not come as a surprise to any medical physicists. These are well documented, well accepted standards that are published and align with AAPM Task Group reports and other professional recommendations. Practice accreditation is doing what we all know is right and confirming it’s effective.
Sue: I think that's why accreditation can be undervalued. People look at the requirements and say to themselves, well, of course we do that. But one of the things that we discovered when we went through APEx was that while we do a lot of those things, the process of having a deadline, a formal assessment, an outside evaluator meant that we still discovered new things. Everything just got squared away with the accreditation process, and it was extremely informative.
Patient safety is a key aspect of radiation therapy every day; however, PSAW presents a chance to assess your own practice. Many tools, like RO-ILS and APEx, are used by radiation oncology practices around the country to measure and improve the consistency and effectiveness of daily practice. ASTRO challenges you to take advantage of PSAW to evaluate your own practice and learn how RO-ILS and APEx can help with your patient care.