The Dose Debate
By Elaine Sanchez Wilson
During the last 5 years, a spotlight has been cast on the issue of radiation dose management, fueled by public concern in the aftermath of two incidents of excessive radiation administered in California in 2009. These medical errors captured the attention of major media outlets, and—as is the case of many highly publicized news stories—they drew a response from legislators as well.
In the last 5 years since these events took place, states—and most recently, the federal government—have enacted mandates with an aim to protect patients during ionizing radiation-emitting imaging exams. From dose monitoring and reporting requirements, to equipment safety regulations, healthcare providers are having to reevaluate their internal policies and protocols to determine whether they are compliant within the ever-changing imaging landscape.
A Proactive Approach
In 2010, California passed SB 1237, a law that directs facilities to record radiation dose on every CT exam, except studies used for therapeutic radiation treatment planning or delivery. It also instructs providers to include dose data in the radiology report, establishes dose thresholds, and requires organizations to notify state authorities of instances when these thresholds are exceeded.
Texas followed with its own law, which includes regulations surrounding fluoroscopy in addition to CT as well as a requirement for the establishment of radiation protocol committees. And in Connecticut, the state’s House of Representatives is currently reviewing a bill that is similar to California’s dose reporting law and also includes a provision for mandatory annual CT scanner inspection.
Meanwhile, on the national front, the Obama administration passed the Protecting Access to Medicare Act on April 1, which sanctions healthcare organizations with Medicare payment cuts if their CT equipment does not comply with a new radiation dose optimization standard instituted by the National Electrical Manufacturers Association (NEMA).
Referred to as MITA Smart Dose CT, or XR-29, the Standard Attributes on CT Equipment Related to Dose Optimization and Management includes four features: 1. CT Dose Check, an earlier standard that calls for dose notifications and alerts; 2. DICOM structured dose reporting, which enables the provider to record the dose emitted during the scan; 3. An equipment feature called Automatic Exposure Control, which doesn’t necessarily reduce dose, but rather adjusts the emitted dose based on the body habitus of the patient being imaged; and 4. Adult and pediatric reference protocols, on which the Medical Imaging and Technology Alliance (MITA) worked in collaboration with the American Association of Physicists in Medicine (AAPM).
William Muhr, MD, president and CEO of South Jersey Radiology Associates, points out that the concept of “low dose” is not a new idea in radiology. “It’s been around since I was a resident in the dark ages,” he said, with a chuckle. “The concept that you want to limit radiation dose, I think has been around for a long time. I’m just not sure in practice that we—as a field, as a specialty, and as an industry including vendors providing equipment—were as diligent with that as we should have been.”
Neomi Mullens, a project manager for Ascendian Healthcare Consulting, encourages healthcare providers to work on making sure their own organization’s internal processes are established before going out and buying new technologies. “They should set organizational road maps to fully understand where they are and where they want to be,” she said. “Proactive efforts will ease the transition to and adoption of legislation as it becomes law, and they will have laid a solid foundation internally to readily adopt new policies and procedures. Ensuring the organization is engaged with implementing or revamping a radiation safety program will reset the clinical mainframe to provide the best practices for radiation safety and radiology practices.”
For example, Muhr says his practice aims to stay ahead of the curve in terms of its technology. “We felt that we really wanted to get a handle over the last couple of years on radiation dose, be ahead of the curve, and have that information proactively rather than wait for legislation,” Muhr said.
One of the first things South Jersey Radiology Associates did was examine and analyze its existing protocols. “We looked at what we could do with our current equipment to drive down the dose as low as we could and still deliver the images that radiologists thought they needed,” Muhr explained. As a result, the practice began implementing lower kV settings for thin patients. It utilized all of the tube current modulations that its various scanners had on them. They also studied ordering patterns from referring physicians who routinely ordered studies with and without contrast; when appropriate, they would reach out to these referring physicians and advise them that only a study with contrast was necessary, therefore avoiding the doubled radiation dose.
Although the California incidents were not mechanical failures, it was alarming enough that the manufacturing industry came together through MITA, along with the Food and Drug Administration and the AAPM, to try to make equipment even safer.
In 2010, the groups developed a Dose Check standard that incorporated a dose alert—a yellow light that signaled to the CT operator or technologist that a particular study was administering a relatively high dose level or a red light notifying users that the dose was above a level either recommended by the FDA or perhaps predetermined by the facility. End users would have to hit “accept” to move forward or readjust the dose level. “The whole idea was to make the dose amount transparent to the operator so they can make a judgment on whether it’s the right level,” said Dave Fisher, Siemens vice president of healthcare policy and strategy who previously served as MITA executive director.
However, today, a fair number of healthcare providers still use old, outdated CT scanners, some of which are simply too old to be upgraded. What, then, are some obstacles for those wishing to become compliant to radiation safety standards? Financial constraints, for one, are a major hindrance. With regard to Dose Check, the standard was published at the height of the recession. “Unfortunately, all of this happened at a time when hospitals were really dialing back on their purchases and on training for their staff,” said Gail Rodriguez, current executive director of MITA. “It was kind of that perfect storm.”
Mullens noted another reason why compliance may not be a top priority for some organizations. “[Radiation dose reporting standards] have come about during a time when the medical community basically became saturated with new laws and requirement mandates,” she said. “Providers have been forced to take on so many new changes both legally and from a technological standpoint on how they’re delivering patient care. With mandates regarding electronic medical records, mandates regarding the implementation of various technologies, mandates outlining specific patient data that must be collected and how and where it must be stored, healthcare providers are overwhelmed by this saturation and find themselves trying to become compliant and maintain compliance, while at the same time still providing great patient care.”
XR-29 evolved after MITA and its partner organizations identified components that most providers could use right now. “We didn’t want to write a standard that nobody could comply with or that nobody could meet,” Rodriguez said. “But again, we didn’t want to make it so basic that everyone was already meeting it. We wanted to drive them to use these new features. That’s how we came at that balance.”
MITA hopes that the standard will be put to work through a variety of avenues. For example, the Alliance has requested the accrediting bodies, such as the American College of Radiology, Joint Commission, and Intersocietal Accreditation Commission, to reference XR-29 in their accrediting requirements. Also, through marketing strategies, many vendors are promoting their equipment as XR-29 compliant, which may appeal to consumers in the marketplace. And of course, a payment policy is another strong message to send to providers, though if MITA had its way, it would be through rewards and not penalties.
Offering the analogy of airbag or backup camera requirements in automobiles, James Brink, MD, Radiologist-in-Chief, Massachusetts General Hospital, and Juan M. Taveras Professor of Radiology, Harvard Medical School, said the safety legislation would ensure that providers are using modern equipment, designed to protect patients. “The manufacturers have done a good job of creating advances in equipment that would tremendously lower dose, and this bill is about trying to bring the imaging fleet to that level of sophistication,” said Brink, who is also Vice-Chair, Board of Chancellors, at the ACR. Specifically, hospitals, physician offices, and freestanding imaging centers not in compliance with the MITA Smart Dose standard will be subjected to a 5% reimbursement cut for CT scans on noncompliant equipment in 2016. The following year, that reimbursement reduction will increase to 15%.
According to Muhr, the newer equipment embodies all of the current iterative reconstruction techniques, which dramatically lowers dose. Keeping this in mind, his practice looked at its stock of equipment and planned a “5-year roadmap for the future,” Muhr said. This included undertaking a fairly large wholesale replacement of its CT scanners to include those with dose-reducing iterative reconstruction algorithms and dose modulation features. Another advantage of purchasing newer CT scanners is that service costs are usually relatively lower. “Even though there could be more capital costs up front, sometimes your 5-year cost of ownership isn’t any more than doing nothing because you can really drive your service,” Muhr said. Providers can work with their vendors to have service delivered remotely on these newer machines, for example.
Although it was universally agreed among the experts interviewed for this article that updating equipment to modern-day standards was by and large a good thing, several experts noted that reporting dose, although noble in its intent, might come with a number of drawbacks. For one, dose figures are only estimates. “I think at some point it’s going to be mandated,” Muhr said. “But the concern isn’t putting in the report. The concern is making sure the referring doctor and the patient understand what that information means.”
Brink is both understanding and supportive for the need for transparency with regard to dose data. Nevertheless, he cited a major concern with the reporting of these values. “The implications of that data are not well understood,” he said. “There is a level of uncertainty with regard to the actual dose metrics that should be tracked and a poor understanding of what risk estimates from those dose metrics would mean. My concern is that some will be tempted to start adding doses together, and poor decisions will be made based on information that is not completely understood.
“My fear is that the risk of bad decision-making will outweigh the benefits of reporting dose in radiology reports,” he said.
Once dose data becomes reported, the natural question from patients may be “What is my risk?” “Here I think the impact of comorbid conditions, life expectancy, and age becomes very important to understand,” Brink said. “When I lecture on this topic, I highlight the uncertainty with regard to risk estimation from dose and the impact of age and life expectancy making it even more uncertain.”
Brink pointed out that The Joint Commission’s proposed changes for diagnostic imaging standards have yet to be adopted, due in large part to these uncertainties. “There was a vigorous response made by the ACR, Image Wisely, Image Gently, and other organizations, to try to help shape these into a more meaningful standard. They are considering the feedback that was provided.”
Furthermore, the FDA in partnership with Image Wisely explicitly chose not to include specific dose data on the medical imaging history card that these two organizations jointly sponsored. “When we formed Image Wisely a few years ago, we partnered with the FDA for a My Medical History Card that patients could fill out to keep track of imaging exams, including the date, exam type, and where the exam is performed,” Brink said. “We made a conscious decision not to include the radiation dose metric.”
Are Mandates Necessary?
On the other hand, healthcare consumers stand to benefit greatly from dose reporting, according to Fisher, who, during his time with MITA, worked with California on the development of its dose reporting law. “There’s a growing desire by the population for transparency in healthcare, and I think this is just one more element of how transparency in healthcare can be brought to the patient in order to improve their understanding of the health system and its impact,” he said. “In my view, it’s clearly a step forward for our healthcare system to have these types of policies in place. By helping patients understand more about their condition and more about the way they’re interacting with the healthcare system, it’s good for them and good for healthcare efficacy overall.”
Another upside to legislation is patient awareness, said Erin Doty Georges, MITA director of federal and state government relations. “When you introduce legislation like this, I would venture to say a lot of folks don’t know when they go for a CT scan that there’s even the possibility that they might be getting too much radiation, that it’s possible to regulate, and that their physician may not have the ability to do that,” she continued. “If their patients are pushing for it, then that can be another driver to incentivize physicians to upgrade their equipment.”
According to Brink, “It is important for us to respect the spirit of why these regulations are being proposed and be as supportive as possible for the general purpose of protecting our patients. On the other hand, I think it is important to be vocal about what is realistic and what is reasonable with respect to not overscaring people.” For example, Brink said, when passengers purchase an airline ticket, they do not expect to be given information on the pilot’s level of experience, the maintenance record of the plane, and the fuel gauge and tire pressure values. “There are a lot of details that we trust the airlines to manage for us,” he said.
Nevertheless, Brink believes compliance “is fairly easy when it comes to embedding the dose data into the report. One thing that people may not realize is that the dose data from most CT scanners is provided with the images. We have access to the dose data in the medical record, through the imaging record. Simply cutting and pasting it into the written report is really all it takes to comply with these standards. It’s an exercise that is relatively easy to execute.”
In Mullens’ view, compliance should not be the be-all-end-all. “If an organization is truly vested in elevating radiation safety standards and practices, then blindly going out and procuring a radiation dose management technology solution with the sole purpose of checking off a compliance check box is the wrong approach,” she said. “If they’re capturing the data and putting it on a patient jacket and keeping it in their medical records, that’s great, that’s compliant, but are they looking at it? Are they evaluating whether they’re using the most appropriate levels of radiation?”
Ultimately, Mullens believes “now is a time for all facets of the medical community to step forward and voice their opinion on the different critical components that need to be considered and streamlined when addressing radiation dose management,” she said. “There’s a strong voice from physicists that needs to be considered. There’s a strong voice from clinicians and radiologists that needs to be considered. There’s a strong voice from business stakeholders to be considered, not only from a financial standpoint, but also regarding marketing and communication to their patient population. It is so critical to address the multiple layers of complexity found within the development of a robust radiation safety program. Progress will be driven by understanding process, technology, and the delivery of patient care in regard to radiation dose safety.”
Elaine Sanchez Wilson is a contributing writer for Axis Imaging News.