Cardiac imaging accounts for about one-third of the source of X-ray radiation dose for all medical imaging. Expanding use of computed tomography (CT) for cardiac evaluations, use of nuclear imaging for myocardial perfusion exams and more complex transcatheter procedures in the cath lab have all increased patient exposure in recent years.
Concern over cumulative patient and staff radiation dose from CT and angiography has prompted legislation for dose recording in a few states. Other states are expected to follow suit with their own legislation.
In 2014, there were two key radiation monitoring reforms created to begin a process for recording and monitoring dose as a regular part of hospital operations. The Joint Commission changed its rules for credentialing facilities by now requiring dose-recording software so facilities can get a handle on doses used and how to reign in high-dose outliers. The Joint Commission’s view is that it is not possible for a medical facility to know exactly how it is doing in regards to patient radiation safety or use of “as low as reasonably achievable” (ALARA) dosing principles if it does not track the data. The software enables hospitals to build a more robust radiation safety program and re-evaluate their radiation safety practices. Empirical data from these systems offer justification for changing imaging protocols and revision of workflows in both radiology exams and interventional procedures.
In addition to requiring a method for collecting and storing dose data within the patient’s clinical record, the Joint Commission guidelines call for implementation of a robust and dynamic radiation safety program. This includes an engaged radiation safety committee and physicist who regulate radiation safety practices, annual performance evaluations of imaging equipment by a medical physicist, registration and certification of all radiology technologists, and updated protocols for all imaging procedures including the pediatric population.
Congress also passed H.R. 4302 in 2014, which delays the large cuts in Medicare called for by the Sustainable Growth Rate (SGR) if imaging facilities meet new requirements for stricter patient radiation dose safety controls in efforts to lower dose. This requires all CT scanners to adhere to NEMA radiation dose standards by January 2016. Medicare payments for services rendered with equipment not consistent with the National Electrical Manufacturers Association (NEMA) standards would be reduced by 5 percent in 2016 and 15 percent in 2017 and subsequent years.
Medical imaging software vendors have introduced several options to record the dose from each exam from multiple X-ray and nuclear imaging modalities. These systems often package that data into dashboard management apps to monitor doses based on specific machines, protocols, departments and technologists.
Determining Standard Doses
Some picture archive and communication system (PACS) vendors incorporate dose reporting directly into their systems, but most software currently available is in the form of bolt-on modules that work with a PACS. Data generated from this software can be presented in several ways, often with dashboarding capabilities to track various parameters set by the facility. Some software types only track dose levels for individual patients to include in their electronic medical record (EMR). Another type only tracks dose levels used overall for quality metrics, such as dose by each CT scanner or cath lab, operator, tech, protocol and patient size. These latter systems are designed to help providers reduce dose by showing them how they are performing.
There are no national standards for dose levels that should be used, so the American College of Radiology (ACR) is working to collect this data by creating the Dose Index Registry (DIR). There are a growing number of providers who participate in the voluntary registry. Participants receive data comparing their dose usage to others nationwide and in their area. The DIR includes dose data on all imaging exams at the facilities. The registry now includes several million exams' worth of data and will be used to determine common dosages based on modality, exam type, protocol, patient size and equipment used. The DIR data is expected to be leveraged in coming years to set national dose standards. Participation in the DIR requires dose-recording software compatible with the registry.
Vendors in the Dose Recording Market
KLAS interviewed 100 providers in 2014 for a market report on dose monitoring solutions and two vendors are prominent among providers — Bayer and GE Healthcare.
"While Bayer and GE are currently capturing the majority of the mindshare, other players have garnered some attention. However, they have an uphill battle in trying to compete with the two mindshare leaders," said Matt Terry, the report’s author. "The interest level is high as organizations attempt to figure out which solution makes the most sense for them. Options range from full, robust solutions with all the bells and whistles, to simpler solutions that can still get the job done, to PACS solutions that now offer dose monitoring capabilities."
Bayer Healthcare’s Radimetrics eXposure dose management software is a third-party solution that is resold by several PACS and cardiovascular information system (CVIS) vendors, including Philips, Siemens and McKesson. Bayer unveiled version 2.5 of its Radimetrics Enterprise Platform at the 2014 Radiological Society of North America (RSNA) meeting. The enhanced version has new features that can help radiologists and hospital administrators meet new 2015 Joint Commission standards, providing information to help optimize radiation dose management and contrast dose analytics to advance image quality and patient care. New features include more advanced contrast dose analytics and new charts and data options to help identify repeat injections and issues associated with intravenous administration.
GE’s DoseWatch retrieves, tracks and reports the radiation dose administered to patients and automatically organizes the data for hospital management so they can easily monitor dose delivery in their institution. The system collects data by imaging device, the individual operator or by protocol so it can easily identify dose outliers. The software offers a dose comparison analysis tool where users can compare doses between facilities, across systems and among protocols.
GE recently launched its Cath Lab Efficiency Manager, which incorporated analytical tools to analyze the performance of an interventional lab, providing hospitals with important data they can use to identify areas of improvement, including radiation dose and fluoro time data.
Other dose monitoring software players being considered were Agfa HealthCare, Bracco, DR Systems, Infinitt, Imalogix, McKesson, Novarad, PACSHealth, Philips, Radiance, Scannerside, Sectra and Siemens. Additional vendors who supply solutions are Cerner, Aware Inc., Toshiba and Raysafe.
Sectra’s Web-based DoseTrack automatically collects, stores and monitors data from all connected modalities. Sectra is a certified ACR software partner, approved to submit a hospital’s dose data to the DIR.
PACSHealth’s DoseMonitor automates dose monitoring and reports. It can help ensure imaging exam consistency, maintain regulatory compliance and manage radiation dose at an enterprise level from a single application.
Infinitt’s Dose M 2.0 radiation dose tracking software expands the capture of dose data from multiple modalities and can be integrated with radiology information systems (RIS), PACS or EMRs. It provides integrated statistical analysis by device for modality quality control (QC) and quality assurance (QA) and automatically notifies appropriate staff by email alert when dose exceeds the defined threshold value. It also interfaces with the DIR.
Aware Inc. offers the AccuRad REM Server to collect radiation exposure data based on the Integrating the Healthcare Enterprise's Radiation Exposure Monitoring (IHE REM) profile to generate customized dosage estimation reports and upload data to the DIR.
Cerner Corp. featured its RadNet Radiation Dose Documentation functionality at RSNA 2014. It includes tools to receive dose data into the Cerner Millennium EMR from the imaging modalities through the DICOM Radiation Dose Structured Report. It also displays dose data incorporated into the technologist and radiologist workflows.
Sapheneia announced in December 2014 a partnership with Scannerside to provide its comprehensive dose strategy (CDS), which in addition to monitoring dose optimizes image protocols and reduces dose with ClearCT. The partnership aims to quickly track dose per patient and provide comprehensive dose solutions at competitive pricing.
Siemens Healthcare at RSNA 2014 showed its work-in-progress cloud-based network solution Teamplay. It is designed to make it possible to evaluate the extensive amount of information generated by imaging devices. This includes data mining scanner capacity utilization, examination times or radiation doses and to compare the numbers against in-house and third-party reference values.
2. “Radiology Dose Monitoring Solutions 2014: Provider Strategies in an Evolving Market.” KLAS Report, April 2014.