A Case For RO-ILS

First, A Short Story

We’ve all heard reports from colleagues about how radiation treatments sometimes just go wrong. Typically, you hear the most egregious accounts, and they have a way of sticking with you. I’m aware of an incident that happened some 10+ years ago that still haunts me when I think of it:

A patient was undergoing stereotactic radiosurgery (SRS) for a solo metastasis in the brain. The physician, physicists, dosimetrist, and other staff joined the therapists at the machine to partake in the treatment, forming the all-important stereotactic “cockpit.” The treatment commenced. The first pair of fields of the cone-based SRS treatment progressed as anticipated until the physicist noticed something was amiss. He forcefully commanded the therapists to stop the beam.

 

Paying close attention to the treatment console screen, he noticed that the jaw size was set to 10 x 10 cm², twice the size of the 5 x 5 cm² recommended for cone-based plans. The plan size gaffe resulted in hundreds of monitor units delivered to normal, healthy brain tissue that poured into the corners of the large jaws outside the cone shielding. Thankfully, this patient avoided serious damage and did not experience any short- or long-term effects because of this plan error. The impact of this error could have been much worse if the entire treatment had been completed.

This error originated during the treatment planning process when the dosimetrist entered incorrect jaw sizes, using 5 cm for each independent jaw (Y1, Y2, X1, X2) instead of 5 cm total in the Y and X-direction. Unfortunately, it passed undetected through secondary dosimetry review, physician plan review, physics plan checks, and therapist plan review. In investigating root causes, the clinical team discovered that events of a similar nature had happened before at other sites throughout the country and abroad.

This is an instance in which a widespread incident learning system could have prevented additional mistreatments. The first occurrence of such an error could have been reported and disseminated to encourage proactive investigation into processes to avoid it in their clinics.

 

A Radiation Oncology Incident Learning System For All

Launched in 2014 by ASTRO and AAPM, Radiation Oncology Incident Learning System (RO-ILS) quickly became the preeminent national platform for collecting patient safety information in a central database.

This database is managed by a federally listed patient safety organization (PSO). The Patient Safety and Quality Improvement Act of 2005 established PSOs and granted them the ability to voluntarily collect data in a confidential and protected environment. This provides practices the comfort of knowing that their sensitive information is being appropriately managed and is not discoverable while still enabling shared learning.

Since its debut, more than 650 facilities have enrolled in RO-ILS. Departments enrolled in RO-ILS have access to an online platform that provides anonymous reporting, a critical feature for promoting a safety culture. The online portal contains analysis tools, a dashboard, and the ability to graph and export data. This all supports local data analysis and quality improvement. Data reported to the central database managed by Clarity PSO is triaged and, when appropriate, is reviewed by a radiation oncology safety expert. These individuals work in a protected environment within the PSO and comprise the Radiation Oncology Healthcare Advisory Council (RO-HAC).

 

More Reported Errors Is A Good Thing

With more facilities agreeing to share data, RO-ILS is consistently seeing over 1,000 events reported per quarter over the last few years. While perhaps troubling at first blush, this may actually be a good sign. According to Eric Ford, PhD and Suzanne Evans, MD, co-authors of Incident Learning in Radiation Oncology: A Review, “increased reporting in fact is a sign of a safety-minded department, so—almost paradoxically—more reports is a metric of success.”

 

In this vein, RO-ILS encourages practices to identify and report all events – not just those that reach the patient (i.e., an incident). As we continue to improve our clinical safety, there is a lot we can learn from these near misses and smaller errors.

Since the program’s inception, there has been a general upward trend in event reporting. However, as can be seen from the graph, there was a significant drop in quarter two of 2020, coinciding with the start of the COVID-19 pandemic. An abstract at ASTRO’s 2021 Annual Meeting discusses this drop in reporting. A likely reason for this is that time and resources were diverted away from voluntary programs like RO-ILS to address more critical operational demands. Participation has since rebounded and is again increasing to pre-pandemic levels.

 

Resources For Process Improvement

What is done with the potential wealth of knowledge in the central database? RO-HAC analyzes the error reporting database and develops education to inform the radiation oncology community of noteworthy events and trends. From these efforts, the first peer-reviewed journal article originating from RO-ILS data was published in 2017. After a detailed analysis of the highest priority events, RO-HAC identified some common error pathways. The piece featured in PRO highlighted and expanded upon three main error types: problematic plans approved for treatment, wrong shift instructions given to therapists, and wrong shift performed at treatment.

Many more educational resources have been released on the RO-ILS webpage. Select case studies spotlight unique clinical cases and provide possible mitigation strategies for consideration. In addition to in-depth case reports, RO-ILS routinely publishes quarterly data reports showing statistics from the central database. Themed reports contain multiple case examples around a particular focus area, from specific technologies, QA processes, or contributing factors. To foster and facilitate engagement, recent RO-ILS education has included safety check question(s). For example, Case Study 11 poses the discussion question, “How does your practice handle distractions at the treatment console?”

RO-ILS explores a variety of avenues to promote shared learning. RO-ILS data and analyses are presented at various conferences throughout the year. For example, a panel session discussing challenging cases in patient safety at the 2021 ASTRO Annual Meeting was well received. A few small excerpts are publicly available, and RO-ILS and ASTRO’s Accreditation Program for Excellence (APEx) participants received access to the full recording as a part of ASTRO’s Quality Improvement Newsletter.

An underlying factor in process improvement is culture, which applies at the community level and within each department. While promoting a strong safety culture takes time, it should be a priority alongside a fair, just, and collaborative environment fostering learning. Fruitful discussions of cases within an interdisciplinary safety and quality improvement committee help support a proactive and inclusive culture.

Additionally, RO-ILS users can attend user meetings as an opportunity to discuss RO-ILS errors with other participants. National events, such as Patient Safety Awareness Week in March, are an opportunity to celebrate successes and further promote safety.

 

Engagement and Support

According to ASTRO’s Chair, Laura Dawson, MD, “RO-ILS is a key pillar of ASTRO’s Target Safely campaign, a comprehensive plan to improve safety and quality for radiation oncology. We are proud of the community’s immense interest in the program and our accomplishments over the past eight years.”

RO-ILS, ASTRO, and AAPM should be proud. This is a very active and successful national program, and specialty-specific PSOs are rare. Numerous resources and countless hours are poured into the program behind the scenes. Due to the hard work and effort put forth for RO-ILS, radiation oncology practices across the country are able to enroll and participate in the program for free.

Dr. Dawson further explains, “RO-ILS was developed for the betterment of the field. We believe it is one of the most important avenues to improve safety and patient care. The success of this program is tied to our collective commitment to facilitate patient safety efforts.”

Radformation wholeheartedly agrees that this is a beneficial resource for our community, as it supports quality improvement and better patient care. By learning from errors occurring elsewhere, departments can design interventions to prevent those same errors in the future. For this reason, Radformation is proud to be a Safety Ally and supporter of the program.

For all of us in the radiation oncology community, patients are at the center of everything we do. By supporting, participating, and learning from RO-ILS together, we can do more to serve our patients better. By doing so, we can prevent similar errors from happening and ensure that no jaws are ever again twice the size they should be.