By Cindy Tomlinson, Senior Patient Safety and Regulatory Affairs Manager
Is your practice interested in becoming licensed to use radiopharmaceuticals? Or, are you interested in becoming an authorized user to administer radiopharmaceuticals? With new radiopharmaceuticals gaining approval from the U.S Food and Drug Administration and more in the pipeline, now is a good time to understand some practical steps to take.
Before starting the process, however, it is important to note that agreement states1 may have different forms or requirements for obtaining a license, and we recommend familiarizing yourself with those requirements to ensure compliance. Links to state radiation protection programs, as well as links to state regulations, can be found on ASTRO’s State Regulatory Library.
- If your practice or facility is already licensed to use byproduct materials, the next step is to discuss necessary license amendments with your radiation safety officer. Compliance requirements differ based on whether you have a broad scope license or a limited scope license:
- If your practice or facility has a broad scope license and changes to the license are needed, including revisions to the list of authorized users, your radiation safety officer can handle those in house. Keep in mind that these changes are subject to review during regulatory inspections.
- If your practice or facility has a limited scope license, you will need to submit the specific training and experience for each proposed user, and the facilities and equipment available to support each proposed use, to the appropriate regulatory agency (either the Nuclear Regulatory Commission (NRC) or the agreement state) for review and approval. If the licensee wishes to make changes, such as adding or removing an authorized user, the regulatory agency must approve the requested change. In this case, the NRC has forms for licensees to fill out, while agreement states may have their own forms, so it is important to contact your state’s radiation protection program to find out what forms are applicable to your situation.
- If your practice or facility is not already licensed to use byproduct material, you must submit an application to the NRC or your agreement state. Fees are assigned to each license type as are program codes for medical facilities, practices and laboratories.
ASTRO believes that it is important for radiation oncologists to expand their scope of practice to include radiopharmaceuticals. ASTRO has worked with Congress and the NRC to ensure that appropriate training and experience requirements for radiopharmaceuticals remain intact.
If you have any questions, please contact Cindy Tomlinson.
 Agreement states
are those states who have entered into an agreement with the NRC effectively assuming the role of the NRC.
By Kelly Paradis, PhD
Our first child was born in the summer of 2018. It had been an arduous road to get to that point, but we were ecstatic at the arrival of this tiny little girl who came screaming into the world. My husband Eric, a professor of physics, was amidst his summer semester and covertly disappeared into our rainy bubble of chaos, laughter, tears and precious few hours of sleep. I soon became convinced that parenthood was a conspiracy — how had I not realized how difficult this would be? I googled a thousand iterations of, “is it normal if baby poop looks like…” and crumbled into tears if I dropped clean laundry on the ground (this would later be diagnosed as postpartum anxiety). I took the equivalent of 12 paid weeks of leave from my job as a clinical medical physicist: Six weeks at 0% effort, and then another six staggered over several months. It was classified as “extended sick” time. Though six weeks of parental leave for the birth of a child was included in Eric’s contract, the implications were clear that taking it would impact his chances of achieving tenure. He returned to work full time in the fall. Meanwhile, I considered never leaving the couch again.
Our second child was born in late summer of 2020, a time characterized by a haze of masks and nasal swabs and rooms drenched in bleach. It was 3:00 a.m. when I nudged Eric to tell him I thought we might need to go to the hospital. The next two hours were a rush of drowsy toddler, quiet city streets lit by dim lamplight, frantic phone calls to colleagues and Eric arriving moments before the birth of our second daughter. I was desperate to leave the hospital, where every interaction seemed dangerous and every surface menacing. At one point, while clutching my day-old child to my chest and standing barefoot in a half-tied hospital gown, I declared, “I think we are going to go home now,” to which our very patient nurse replied, “Ma’am, that’s not how this works.”
During this second rodeo, I took 12 consecutive weeks of what was then newly classified as maternity/parental leave by my institution. Eric, tenure in hand, negotiated a modified fall schedule that was the equivalent of six weeks of leave. We were largely alone, my family too far away to travel safely, and Eric’s family forcibly separated from us by border closings. Months earlier I’d had a phone conversation with a U.S. Customs and Border Patrol officer about whether Eric’s mother crossing the Canadian border a few weeks before my due date to ensure Eric could be there for the birth of our child constituted as “essential travel” (it did not). Together, we did the best we could with the resources we had. And, I have to acknowledge how incredibly privileged we were to have access to paid parental leave at all, as many in the United States still do not.
While sufficient paid leave for the birthing partner is critical, the fact that leave for non-birthing partners is frequently ignored is a clever assault on gender equity. It defaults mothers to caregiving-focused roles, where their careers are deemed less important compared to their partners’, and exacerbates biases in hiring, the gender pay gap, the dearth of women in leadership roles and attrition. If we must make a “business” argument, academic medical institutions know how extraordinarily expensive it is to replace faculty. Equal and adequate paid leave for both partners when a child is added to the family, beyond simply being humane, is also the economically sound path.
The stigma against men who take parental leave remains a significant barrier. U.S. Secretary of Transportation Pete Buttigieg recently had to defend attacks against him for taking parental leave after he and his partner adopted twins. Palantir co-founder Joe Lonsdale articulately responded that any man taking six months of leave was a “loser.” Relatedly, a 2019 study published in JAMA Network Open found that in a survey of 844 physician mothers, less than 10% of partners took leave from work, and only 3% took more than two weeks. For non-birthing partners with access to paid leave who returned to work early, 44.9% of first-time parents cited a personal preference to return to work earlier, and 33.3% had intrinsic feelings to not take leave because others did not take paternity/domestic partner leave.1 Clearly, there is work to do.
I am grateful to the American Board of Medical Specialties for their new policy stating, “Member Boards must allow all new parents, including birthing and non-birthing parents, adoptive/foster parents, and surrogates to take parental leave.” In the 21st century, it should be embarrassing for an institution to have varying leave policies dependent on a parent’s gender or specific path to parenthood.
Four years ago, when I was pregnant for the first time, my mother gently said to me that I didn’t realize how lucky I was that Eric would be home with me for the first few months after our baby was born. She was right, not only in that I didn’t realize this (how hard could it be?), but also about the impact that it would have on our family for years to come. What’s more, without him at home, I’m not sure I would have returned to work at all. Eric, you’re my hero. Thank you for changing all the diapers while I cried about the laundry.
Kelly C. Paradis, PhD, is an associate professor of Medical Physics and associate chair of Equity and Wellness in the Department of Radiation Oncology at Michigan Medicine.
- Juengst SB, Royston R, Huang I, and Wright, B. Family Leave and Return-to-Work Experiences of Physician Mothers. JAMA Netw Open. 2019;2(10):e1913054.
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.