Are you monitoring equipment and documenting patient dose? If not, your facility’s reputation and your patients’ safety could be on the line.
By Michael Bassett
In 2009 the American medical community was rocked by the news that more than 200 patients at Cedars-Sinai Medical Center in Los Angeles were inappropriately exposed to high levels of radiation from CT brain scans.
That accident (and others), along with accumulating evidence that excessive radiation doses from CT scans could cause cancer, resulted in a number of regulatory and legislative responses. In California, Texas, and Connecticut, comprehensive laws (and in the case of Texas, regulations) were introduced dealing with issues related to radiation safety.
For example, the Connecticut law mandates that healthcare providers include CT radiation dose in patient radiology reports, ensure that the displayed dose on CT scanners does not deviate more than 20 percent from the actual measured dose, and report to the state and referring physicians error events in which dose thresholds as established by the state’s commissioner of public health are exceeded.
“Individual states like Texas and California have been formulating rules around this issue,” said Dominic Siewko, director of clinical dose management at Philips Healthcare. “But now we are getting far-reaching standards.”
Those standards, which went into effect on July 1 of this year, come from the Joint Commission and pertain to hospitals offering MR, CT, PET, and nuclear medicine services. More specifically the standards mandate that providers comply with a number of requirements related to radiation safety: performing annual equipment quality checks, providing annual training for technologists, performing equipment maintenance checks, documenting the radiation dose index for individual scans, adopting imaging protocols based on the latest standards, reviewing those protocols, and verifying patient information and protocols prior to scans being performed.
“To have procedures in place to annually look at your protocols, or look at making sure technologists are certified, or have radiation safety committees with agendas and minutes taken—those are steps that are pretty easy to take,” said Siewko, adding that the tougher issue involves a continuing inability on the part of many providers to document patient dose and to make that information readily retrievable.
“Providers are recognizing that this is a gap they have and they are looking for solutions,” Siewko said. “That’s why you are seeing a rush [on the part of providers] to find software solutions.”
Yakima Valley Memorial Hospital in Yakima, Wash, has been dealing with dose reduction issues for several years now through initiatives like the Image Gently and Choosing Wisely campaigns.
“One of the things we’ve been doing at Memorial has been writing down every dose for every patent exam,” said Dorothy Stotz, the hospital’s CT supervisor.” It’s a manual, cumbersome process, and it’s very difficult to extract data.”
It also makes it more difficult to comply with radiation dose reporting requirements. According to a recent study in the American Journal of Roentgenology examining the ability of a California hospital to comply with state dose reporting requirements, processes that rely on manual data entry are not entirely reliable. Reviewing pediatric chest CTs taken over one year, the study found that about 10 percent failed to meet California’s dose reporting requirements, while 12 percent failed to meet the institution’s reporting criteria.1
“Our institutional processes, which primarily rely on correct human performance, do not ensure accurate dose reporting and are prone to variation in dose reporting format,” wrote the authors. They concluded that “higher-reliability processes, including better-defined standards and automated dose reporting systems” are needed to improve compliance.
“When the Joint Commission came out with their standards we started looking for something that would be more automated,” Stotz said.
Yakima Valley Memorial had already acquired the Medic Vision SafeCT product—a 3D iterative image reconstruction system designed to lower radiation dose while maintaining image quality—in 2012. Now, Medic Vision has added SafeCT Dose Reporting—a single software platform designed to enable compliance with the Joint Commission’s new dose monitoring and reporting standards.
“[With the new software] we can automatically extract and manipulate data without manual input,” Stotz said. “We can export our data by whatever filter we want—by date, by specific CT protocol, by specific patient age, and you can find what your average doses are.
“This made us even more compliant [with the Joint Commission standards] and more consistent with patient doses,” she added.
While Yakima Valley Memorial Hospital is on track to meet the Joint Commission standards that went into effect July 1, that can’t be said for most hospitals, according to Siewko.
“Most of these standards can be met by hospitals just organizing themselves properly,” said Siewko. “For example, many of them revolve around issues like the frequency with which medical physicists inspect their equipment, and all of that is being done anyway. But the piece many of these hospitals can’t do themselves is the dose tracking piece, and that’s why they need help and why it’s the piece getting so much attention. I know from our recent market research that only about 30 percent of US hospitals have dose tracking solutions in place.”
And the consequences of noncompliance are potentially severe, Siewko pointed out, making it more difficult to get reaccredited, which could prove damaging to a hospital’s reputation and have serious financial implications.
That said, Siewko believes hospitals are making efforts to ensure they are in compliance by the time of their next Joint Commission survey (which can occur between 18 and 36 months after their previous full surveys).
The XR-29 Standard
Siewko said that in talking with his customers there is some confusion between the new Joint Commission standards that went into effect July 1, and the National Electrical Manufacturer’s Association XR-29-2013 standard for improved CT radiation safety.
Beginning Jan 1, 2016, Medicare will reduce reimbursements for CT scans acquired from scanners that are anything less than state-of the-art. Under the policy, which was included in the Protecting Access to Medicare Act of 2014, Medicare will cut reimbursements by 5 percent for CT scans acquired on technology that does not meet the National Electrical Manufacturer’s Association XR-29-2013 standard for improved CT radiation safety. That reduction will increase to 15 percent for scans conducted on equipment not in compliance by January 1, 2017.
“With XR-29, if you fail to conform you are looking at a loss of 5 percent to 15 percent over the next few years,” Siewko pointed out. “That’s a financial penalty. But it’s different from a lack of accreditation.”
The XR-29 standard—also known as the Medical Imaging & Technology Alliance (MITA) Smart Dose Standard—provides that compliant CT equipment incorporates the following four dose optimization features:
- Digital Imaging and Communications in Medicine (DICOM) Radiation Dose Structured Report, which enables recording of post-exam dose information in a standardized electronic format. This information can be included in the patient record, promoting the establishment of diagnostic reference levels, as well as facility dose management and quality assurance.
- CT Dose Check, which incorporates two features—dose notifications and dose alerts—warning operators and physicians when dose exceeds established thresholds.
- Automatic exposure controls, which automatically adjust the amount of radiation within prescribed bounds as needed to achieve the desired image quality.
- Pediatric and adult reference protocols, a set of pre-loaded parameters on a CT system that can be selected by the operator to complete a particular clinical task.
According to Thaddeus Flood, MITA’s industry director for x-ray and medical imaging informatics, about two-thirds of CTs currently in use meet the Smart Dose standard.
“There are a number of ways to be compliant,” Flood said. “If you have a brand new, straight-off-the-assembly-line CT, you’ll have a machine that’s compliant. Or you can have a slightly older piece of equipment that has been or can be upgraded. But about 30 percent of the CT install base is so old that it won’t be backward compatible to upgrade.”
How can providers determine whether their systems are XR-29 compliant? If, for example, a provider has a GE Healthcare device, they can simply go to the GE Healthcare Web site and search for “XR-29 compliance,” which will bring them to a landing page with instructions. The same holds true for other CT manufacturers.
According to a whitepaper recently released by MITA, under the law providers “will be required to report when a CT service is performed using equipment that is not compliant with the Smart Dose Standard.” The whitepaper also reports that OEMs (original equipment manufacturer) are also committed to provide the necessary certification documentation for providers to be properly reimbursed.2
When making decisions about whether to upgrade or replace CTs in order to comply with Smart Dose, providers should consider a number of factors, Flood said.
“You should look at your utilization rate on a piece of equipment,” Flood said, “and obviously your patient mix, which affects Medicare payments, and how old your equipment is, because if you are going to replace it at some point anyway, you may want to move that acquisition up. It ends up being an individual financial decision that depends on how much it will cost to upgrade or buy a brand new CT compared to the cost differential from not meeting the standard.”
As for pieces of equipment that don’t meet the standard, “those are by most standards pretty old by this point,” Flood said, adding he expects they could be replaced at an accelerated rate over the next few years with new units or compliant units from the used market.
- Zucker, E. J., Larson, D. B., Newman, B., & Barth, R. A. (2015). Radiologist Compliance With California CT Dose Reporting Requirements: A Single-Center Review of Pediatric Chest CT. American Journal of Roentgenology.
- “Is your CT Smart Dose compliant?” Medical Imaging and Technology Alliance. May 2015. Accessed July 17, 2015 via http://www.medicalimaging.org/wp-content/uploads/2015/05/Is-Your-CT-Smart-Dose-Compliant-Whitepaper.pdf