The most recent Sentinel Event Alert¹ issued by the Joint Commission formally put the medical world on notice that the expanding use of diagnostic imaging will require more stringent oversight to ensure patient safety. Whether that oversight will be self-imposed or enforced from without, the Joint Commission recommends that practitioners be held to more clearly defined standards concerning the overall radiation body burden of their patients, and it lays out 21 specific recommendations. When the ACR® gently chided the Joint Commission for some of the wording in its alert, including mixing up the names of its registries, there was clearly a bit of bristle in the response.² This is an issue on which the college has been proactive, both in launching the Image Gently campaigns and in adding a Dose Index Registry (DIR) to the other active registries that compose the National Radiology Data Registry (NRDR), launched in 2008. The DIR was officially launched on March 14, 2011, as the newest component of the NRDR. In addition to the DIR, the NRDR warehouses seven other specific registries—covering oncologic PET, CT colonography, mammography, IV contrast extravasation, night coverage, pediatric CT quality improvement, and general radiology improvement—that help facilities benchmark outcomes and process-of-care measures and develop quality-improvement programs, according to the ACR. Despite the fact that the DIR has been in operation for just seven months, its chair, Richard Morin, PhD, says that the seeds for the registry were planted years ago, when he chaired the ACR Commission on Medical Physics. The commission came up with the idea of a database that would capture dose information, and the ACR funded the development of software that would automatically extract the amount of radiation associated with a study from the scanner and produce a structured dose report. A pilot involving one vendor resulted in proof of the concept, so other CT manufacturers were invited to participate. “We repeated the pilot with a much larger audience and demonstrated that this was a viable idea,” Morin recalls. Registry Underway Already, the DIR has gathered information from 214 participating institutions, representing more than 150,000 exams and 250,000 individual series of CT studies. The largest single group participant contributes reports from 30 CT devices. Eschewing manual data entry, the DIR software automatically extracts imaging information from DICOM headers using the Integrating the Healthcare Enterprise Radiation Exposure Monitoring profile. By compiling those data, it can help institutions establish guidance on their dose indices for specific exams, relative to national benchmarks. “It’s a way for the institution to see where it stands compared to everybody else,” Morin says. “We designed it, from the beginning, to be operator independent—no human interaction necessary.” Of course, reports generated by the system are only as good as the data that have been entered. There’s no selection bias, Morin says, because every exam performed, on every participating machine, is logged in the system. The democracy of this process leaves its mark in two of the biggest challenges involved with DIR trending: nonstandardized naming conventions for CT studies and differences in patient size. “Sometimes, it can be very difficult to try to match up your exam with someone else’s,” Morin says, particularly when seeking apples-to-apples comparisons of studies of the chest, abdomen, and pelvis. Likewise, body-habitus differences can cloud the accuracy of registry values because CT-beam modulation means that “big, thick people have higher values than small, thin people,” Morin says. “In our pilot, we saw some rather large variances—in some exams, a factor of four to six median values.” Some larger institutions also have shown great internal variances among common studies because their protocols haven’t been harmonized across different devices and software iterations. “We hope, over time, that people will begin to home in on the optimal radiation for an exam. The community has responded very well; the staff is talking to people daily who want to sign up,” Morin says. George Segall, MD, president of the Society of Nuclear Medicine, says that the DIR represents a natural evolution of medical informatics and can be a helpful tool for physicians, but that it should not serve as a standard of judgment—or the basis upon which a determination to perform or avoid a scan should be made for individual patients. “It would not be advisable not to have a test using ionizing radiation due to a fear that a single test is going to have a detrimental effect,” Segall cautions. “Not having an appropriate test is much worse. If patients need these types of tests, they need them, regardless of the cumulative amount of radiation they’ve had in their lifetimes.” He continues, “You could have the same issue if you substitute a national pharmacy or drug registry for a radiation registry. It’s not addressing safety in any particular patient; it’s a quality-improvement initiative.” A Feedback Tool Morin emphasizes that the registry is primarily a tool to benchmark and distribute radiation-dose data. “There certainly are many different aspects of the way people will use the data,” Morin says. “Our biggest goal, here, is to put the tool in the hands of the users.” The DIR is already gaining traction in health-care quality-improvement circles. According to Morin, his committee is working very closely with Image Gently, which is using the registry as a mechanism to capture pediatric data, and the National Quality Forum, which endorsed participation in a systematic national dose-index registry as a quality measure on September 19, 2011. Joint Commission dose-mitigation Recommendations
Among the 21 measures suggested in the Sentinel¹ Event Alert issued by Joint Commission were: • use of modalities other than CT (such as ultrasound or MRI); • collaboration between radiologists and referring physicians in the appropriate use of imaging; • adherence to relevant guidelines from the Nuclear Regulatory Commission, the Society for Pediatric Radiology, the ACR, and the RSNA; • use of proper imaging protocols, with annual or biennial reviews of evidence concerning those protocols; • expansion of the radiation safety officer’s role to include patient safety, in addition to education on proper dose and equipment use for all involved physicians and technologists; and • implementation of centralized monitoring of quality and safety performance for all imaging equipment that might emit high amounts of radiation.
Reference 1. Radiation risks of diagnostic imaging. Sentinel Event Alert. http:// www.jointcommission.org/sea_issue_ 47/. Published September 1, 2011. Accessed October 10, 2011. To gain access to all of the NRDR registries (including the DIR), providers pay a one-time registration fee of $500 and an annual fee ranging from $500 to $10,000, depending on the number of radiologists and sites involved. Once enrolled, participants receive access to their own individual institutional data, as well as to aggregate reports released at regular intervals. “One of the biggest challenges we’ve seen, particularly at large places, is that they have to sign a business agreement and provide a PC to run the ACR software,” Morin says. “Sometimes, depending upon the relationship with the IT folks, it can take some time to do.” Morin hopes that participating institutions will begin to evaluate their imaging protocols internally, undertaking periodic reviews of their practices using the national registry data to provide a basis for judgment. Those facilities that already make use of in-house physics support teams “know quite well where their doses are,” Morin says; they need to know whether those doses are too high or too low. Furthermore, he envisions that the impact of the DIR could extend beyond practitioners to device manufacturers as well. “The values now used started with the literature,” Morin says. “These doses are changing, as new equipment comes out; new scanners do the same scan at a lower dose, with better detectors, different reconstruction techniques, and algorithms that take the noise out of the image.” In as little as two years, Morin expects to see trends emerge across various device brands and models. “What I hope we’ll see, in certain exams, is that the median will trend downward, and the variance will become less,” he says. The Sentinel Event Alert reflects a deeper need for the establishment of a common safety culture, in the imaging world, that “represents dedication to a process,” Segall says. Heightened public awareness of the potential risks of radiation made it timely for the Joint Commission to formalize its policy regarding medical-safety protocols surrounding the use of ionizing radiation, but none of the information in the alert qualifies as news, he adds. “There’s really nothing new in this discussion; there’s really nothing unreasonable about the recommendations,” Segall says. “It’s very helpful to have them collected in one place and advocated by an organization as respected as the Joint Commission, but all of these recommendations have existed and have been supported by numerous agencies, including the government and professional societies, for a number of years.” Nonetheless, the ACR announced, at the end of September, that it would host the First Annual ACR Imaging Informatics Summit and Dose Monitoring Forum, to be held November 3–4 in Washington, DC. The first day will bring together policymakers, vendors, consumers, and providers. The second will provide guidance to practice leaders, radiologists, and medical physicists, giving them a full picture of how a facility can proactively monitor dose indices and communicate relative risks and benefits to patients and referrers. Matthew Skoufalos is a contributing writer for Radiology Business Journal.