Why Your Technology Needs to be Compliant With New CT Dose Standards

After reviewing a new standard for radiation imaging dose requirements, Mike Hopkins’ first thought was complete replacement of all of his CT scanners.

“I’m looking at my four scanners and realizing none have the abilities to do that,” said Hopkins, director of the imaging center at Nebraska’s Saint Elizabeth Regional Medical Center.

On closer inspection, Hopkins’ projected capital outlay looked more manageable as software upgrades and other options surfaced.

“Yes it’s going to cost money, it’s going to hit hospitals, and it’s not an insignificant financial impact,” Hopkins said. “But when you start to investigate, you find there are options.”

Hopkins’ analysis concerned a radiation standard for CT set by the National Electrical Manufacturers Association (NEMA) and its Medical Imaging & Technology Alliance (MITA) division. The standard, XR-29 Standard Attributes on Computed Tomography Equipment Related to Dose Optimization and Management, is also known as XR-29 and MITA SmartDose. It was created largely in response to a 2009 FDA report that approximately 200 patients in an 18-month period received radiation doses far in excess of protocol, explained Priscilla Butler, senior director in quality and safety with the American College of Radiology and a medical physicist. This was around the same time that a child in California underwent an hour of CT scans.                

XR-29 gained traction this year when the U.S. Congress amended Medicare laws. Beginning in 2016, CT scans performed on machines that are not compliant with XR-29 will receive a 5 percent reduction in reimbursement. That reduction increases to 15 percent if machines still aren’t compliant in 2017.

The law has limited reach, however, covering primarily hospital outpatient departments and free-standing imaging centers. 

Hospital inpatient settings - which is where the patients in the FDA’s 2009 report received the excessive doses - will not be impacted by the Medicare law, said Sandra L. Katanick, CEO of the Intersocietal Accreditation Commission. Hospitals can voluntarily meet compliance or seek imaging accreditation through organizations such as hers, she said, but are under no legal obligation to comply with XR-29.

The Joint Commission, which accredits hospitals, said in a prepared statement that it “commends” MITA for working to improve the safety of CT equipment but that it has no plans to require compliance with XR-29.

“Our hope is that hospitals will look at this and agree to upgrade,” said Gail Rodriguez, executive director of MITA. Vendors, she said, “have made a commitment to do as much as they possibly can” to help facilities reach compliance, either through replacing or upgrading their systems.

She estimated approximately one-third of outpatient CT scanners will need to be replaced to avoid penalties.

Understanding the Standard
Providers are already contacting GE to find out what they need to do to be in compliance, Ken Denison, micro imaging and CT dose leader for GE Healthcare, said, and GE is helping them review their inventories.

“It isn’t necessarily as simple as saying, ‘that device isn’t compliant,’” Denison said. “Just like any modification or change to policy, there are a lot of nuances to think through – and that is where many of the providers are at the moment.”

At GE, discussions with hospitals, outpatient clinics and free-standing imaging centers start with a conversation about how the scanners are used to determine the potential implications.

Moving a compliant scanner to an outpatient setting could be an option, he said. “You really do have to take the time to collect the information.”

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 “Significantly more than half” of Siemens scanners in use at facilities across the United States either are in compliance or can be upgraded to compliance, estimated David Fisher, vice president of healthcare policy and strategy at Siemens Healthcare. 

“We do our best to manufacture equipment to make dose information transparent,” Fisher said. “Wherever possible, we’re retrofitting products to get them compliant. We’re doing that now to be prepared for 2016.”

Generally speaking, systems older than 10 years probably should be replaced, Fisher said - although there are gray areas depending on the type of system.

Noting the spirit of the law, both Fisher and Denison said facilities should consider the clinical applications as well as the financial in deciding whether to retire or reallocate older systems. “MITA embarked on this effort to enhance patient safety,” Fisher said. “The value of the dose optimization features is important enough that providers and vendors should be incented to include them.”

Long-Term Savings
At South Jersey Radiology Associates, which has 12 facilities in the Philadelphia area, Muhr Jr., MD, president and CEO, said the company had already decided to replace two of its seven scanners even before NEMA published XR-29.

Another two possibly could be upgraded, “but at the end of the day, sometimes it’s a better investment to spend a little more money and get a new scanner,” Muhr said in a conference call that included a Siemens representative.

Likening CT scanners to automobiles, Muhr noted that new scanners generally come with attractive service agreements. With new equipment, hospitals can save money in the long run on maintenance and parts replacements.

Unraveling the Details
In addition to confusion over compliance for older equipment, a component of the standard - adult and pediatric reference protocols - could be open to multiple interpretations by clinicians, said Donald P. Frush, MD, professor of radiology and pediatrics at Duke University School of Medicine in North Carolina.

As MITA’s Rodriguez explained, adult and pediatric reference protocols are uploaded into the machines by the vendors as reference points for technicians depending on the patient and type of scan. Physicists and clinicians, by and large, developed the protocols. The other three components of XR-29 are:

• DICOM, the Digital Imaging and Communications in Medicine Radiation Dose Structured Report, which allows providers to record dose information electronically. The information can be included in a patient’s record and used as part of quality assurance measures.

• CT Dose Check, which includes both dose notifications and dose alerts. Dose check alerts the technician when the highest dose established for the particular scan underway has been reached, Rodriguez explained. To exceed that dose, the technician may hear an alarm, have to enter a password or get approval from someone else. “It establishes a process where they have to stop and think,” Rodriguez said, before going ahead with a higher dose.

• Automatic Exposure Control, which offers providers a means of automatically adjusting the radiation dose based on the patient’s body size. 

The pediatric and adult reference protocols were driven by the pediatric radiology community concerned that hospitals that did not specialize in pediatrics were scanning children with radiation doses more suited for adults, Rodriguez explained.

Awareness of radiation dose in pediatric patients has been building during the past decade, largely through the efforts of the Image Gently campaign. Launched in 2007 by the Alliance for Radiation Safety in Pediatric Imaging, the campaign includes more than 70 medical organizations worldwide devoted to low radiation doses for children.

While Frush applauded the intention of the MITA standard and of its focus on improving imaging care across all ages, he cautioned that there still is not clarity on how the protocols will be determined and monitored - especially concerning children.

“You could build one set of pediatric protocols that handles a single 5-year-old age group for brain, chest, abdomen and c-spine alone, and have a second set for adults, and theoretically be in compliance,” he said. “But I’d say one pediatric protocol does not address the appropriate range of scanning adjustments and indications for kids of different weights - it doesn’t cover the spectrum of children’s sizes.” 

In addition to standard brain, chest and abdomen/pelvis CT portfolio protocols, Frush questioned whether the protocols might be needed for children of different ages for - as examples - renal stone, tarsal coalition, pulmonary thromboembolism and renal artery stenosis.

His concern centered on practices using older equipment or those that scan children relatively infrequently.

“They may not know how to perform scans across pediatric ages and sizes, and indications as well as pediatric specialty centers,” he said. “We’re counting on the manufacturers to supply that information.” 

There needs to be more guidance concerning pediatric scans, said Chris Tomlinson, administrative director of radiology, Children’s Hospital of Philadelphia. He said he often receives CT studies from counterparts at other hospitals showing excessive radiation dose levels. “Even kids’ studies are coming in at those levels,” he said.

Tomlinson, who has his hospital’s three CT scanners replaced every five to six years to ensure his patients are receiving the best scans at the lowest dose possible, said he believes the standard will put a needed focus on radiation dose levels.

Medicare penalties for noncompliance will be “a good thing,” he said, noting that children, particularly those with chronic illnesses that may require multiple scans over many years, have the longest time to gain radiation-induced cancers.