A diagnostic medical physicist’s guide to the American College of Radiology Fluoroscopy Dose Index Registry

The American College of Radiology (ACR) computed tomography (CT) Dose Index Registry (DIR) has been extraordinarily successful, with dose indices collected for over 102 million CT examinations to date.1, 2 The CT DIR has provided an ongoing source of normative clinical data which has been the gold standard for national and international benchmarking.3 The largest existing normative dataset for fluoroscopically guided procedures is the Radiation Doses in Interventional Radiology (RAD-IR) study, with a data collection period covering the mid- to late 1990’s.4-6 The RAD-IR study included 2142 clinical interventional fluoroscopy procedures, performed at one of seven sites using a single fluoroscope make and model. Much has changed since the late 1990's, including the scope and number of fluoroscopically guided procedures performed; fluoroscope technology, including the introduction of flat panel image receptors and variable added filtration; informatics, including widespread implementation and availability of the Digital Imaging and Communications in Medicine (DICOM) Radiation Dose Structured Report (RDSR); and regulation, including mandatory reporting of reference air kerma (Ka,r) in the United States starting in 2006.7 More recently, reporting of fluoroscopy dose indices has been included as a Merit Based Incentive Payments System (MIPS) quality measure,8 and the ACR National Radiology Data Registry (NRDRTM) has been recognized as a Qualified Clinical Data Registry (QCDR) for MIPS participation. Finally, fluoroscopy is used in a very wide range of medical procedures, ranging from diagnostic procedures such as barium swallow, barium enema, and cystography to complex image-guided interventions such as aortic aneurysm repair and hepatic embolization. The American College of Radiology Fluoroscopy Dose Index Registry (DIR) is the latest addition to the NRDRTM, and the first modality to join Computed Tomography (CT) in the DIR. Launching the DIR is a challenging process, requiring expertise in radiology, fluoroscopy, diagnostic medical physics, and informatics to configure the necessary hardware and software, map clinical facility procedure names to a lexicon of more than 200 standard procedure names, and use summary data reports to perform dose audits and evaluate the clinical use of fluoroscopy. The diagnostic medical physicist, with wide-ranging content expertise in imaging physics, informatics, and medical imaging equipment, can lend their expertise and guidance to the healthcare enterprise and their healthcare institution during this process. The purpose of this review is to provide guidance for sites wishing to participate in the Fluoroscopy DIR, and specifically to provide guidance for the diagnostic medical physicist who is assisting a healthcare organization in implementing the ACR Fluoroscopy DIR. The mechanics of participation will be discussed, as will common pitfalls in the process. This review is based largely on the experiences of the diagnostic medical physicists at the nine sites that participated in the pilot phase of the Fluoroscopy DIR. The pilot phase involved data collection for interventional radiology procedures from March 1, 2018 through December 31, 2019, and manual collection of data regarding fluoroscope configuration and use as well as the accuracy and stability of fluoroscope-reported dose indices.9 Two checklists to aid in preparation for a site launch of the Fluoroscopy DIR have been provided at the end of this review. After reading this review, a site should be able to assemble a Fluoroscopy DIR team and launch the DIR while avoiding some of the major pitfalls that may otherwise be encountered along the way. We recommend that readers of this review also bookmark the NRDRTM Support Page for quick reference when needed. A wide array of expertise is required to ensure a successful launch of the ACR Fluoroscopy DIR at your institution. Key team members and their roles are described briefly in this section. Healthcare organizations that have registered for the NRDRTM have a corporate account within the NRDRTM. One or more user profiles can be assigned to any user account associated with a corporate account. These profiles should be reviewed to determine which, if any, of the Fluoroscopy DIR team members should be assigned specific roles within the site corporate account. Among the NRDRTM user profiles, three specific administrative roles are defined,10 which are described in further detail below. The CAA is the top level administrative role defined in the NRDRTM for a corporate entity (note that a corporate entity may be comprised of any number of facilities). Every participating corporate entity must identify one CAA when they enroll in the NRDRTM. The CAA assigns all other administrative roles for the site corporate account. A CAA can perform most of the functions of other users, with the exception of viewing detailed facility data. The CAA does not need to be the director or manager at the facility but serves as the point of contact for all NRDRTM issues for their associated facilities. The FA is the top level administrative role for an individual facility in the NRDRTM and has the most comprehensive permissions for a single facility, including managing other user accounts. Only one FA may be active for a facility at any time. Every participating site must identify an FA when they add a facility to a NRDRTM Corporate account. The FA can manage accounts and data access across all registries for that facility and can view detailed facility data. A single user may have the FA role at multiple facilities. The third administrative role, RAs are authorized by FAs to manage Facility User accounts. They control access to a specific registry, and may perform all functions of a Facility User. Service Users are authorized by CAAs to create and edit scanner mappings in the TRIAD® Site Server configuration and to perform exam name mapping at the corporate account level. However, a Service User cannot view data or reports, and therefore some team members may need both the Service User and Facility User profiles assigned to their user account. A Facility User can perform exam name mapping at the facility level and view reports. These are not official administrative roles or user profiles in the DIR, however, identifying the right personnel to play the following roles is key to a successful implementation of the Fluoroscopy DIR. The physician champion is the coordinator and director of the implementation process, and is essential to securing and maintaining institutional support for implementation of the ACR Fluoroscopy DIR. Sites in states with requirements for fluoroscopy radiation protocol committees or similar committees may find their physician champion on one of these committees. At other sites, there may be a physician who is interested and engaged in quality improvement efforts who would make a great champion. One place to start looking is in your interventional radiology department, as interventional radiologists have much of the domain knowledge that will be required during later phases of the implementation process. The qualified diagnostic medical physicist is instrumental to a successful implementation of the Fluoroscopy DIR, as their domain knowledge should span the technical aspects of fluoroscopy, radiation dosimetry, informatics, and basic knowledge of the clinical aspects of fluoroscopy. Owing to their broad knowledge domain and scope of practice,11 diagnostic medical physicists can also facilitate effective communication among the other key team members. Implementing the Fluoroscopy DIR requires interfacing with multiple hospital systems and servers, requiring the expertise of an IT specialist, particularly one who is familiar with imaging informatics. The TRIAD® Site Server Administrator is responsible for ongoing maintenance of the TRIAD® Site Server. Both this role and the role of IT Specialist may be played by the same individual. Later stages of implementation will require the expertise of team members who have a deep understanding of the clinical aspects of fluoroscopy, particularly as it relates to the mapping of site-specific facility clinical procedure names to the ACR Common lexicon. While the physician champion may possess this expertise, especially an interventional radiologist, they may not have the time necessary to devote to the task of procedure mapping. It is also possible that some diagnostic medical physicists may possess the necessary domain knowledge to assist in the procedure mapping process. Sites wishing to participate in any registry that is part of the NRDRTM, including the ACR Fluoroscopy DIR, must complete the application process and create corporate and facility accounts in the NRDRTM.12 The step-by-step guide on the ACR website walks a facility through the process of getting started with the NRDRTM. If a site already has an NRDRTM account, they only need to complete an addendum to their existing participation agreement to participate in the Fluoroscopy DIR. No additional registration or fees are required for a facility currently participating in the CT DIR or General Radiology Improvement Database (GRID) registries. The TRIAD® Site Server software13 allows a corporate account to collect, de-identify, and transmit data securely from their facilities to the NRDRTM registries. The TRIAD® Site Server software must be downloaded, installed, configured, and maintained by a site administrator on a dedicated physical or virtual server behind the site’s firewall. A single TRIAD® Site Server can support an entire corporate account, including multiple facilities and participation in multiple NRDRTM registries. DICOM RDSR from fluoroscopes at participating facilities must be transferred to the TRIAD® Site Server, where they are anonymized before they are forwarded to the ACR DIR Central Server. Fluoroscopes can be connected to the TRIAD® Site Server in a number of different configurations. While the ACR prefers that data be sent directly from fluoroscopes to the local TRIAD® Site Server, other configurations are not prohibited, and may be more efficient for sites with many fluoroscopes or multiple facilities. Only fluoroscopes that produce a DICOM RDSR are eligible to be connected to the registry, secondary capture dose sheets are not accepted and will not be processed. Configuring fluoroscopes to create and transfer RDSR to another DICOM node may require service level access. This step is typically performed by the local service engineer under the guidance of the diagnostic medical physicist. The simplest configuration is to establish a direct DICOM connection between each fluoroscope and the local TRIAD® Site Server, and then configure each fluoroscope to automatically create and transfer the RDSR to the Site Server after each procedure. Prior to configuring the fluoroscope, the local TRIAD Site Server must be installed and properly configured. Three pieces of information will be needed from the TRIAD® Site Server administrator to configure each fluoroscope: Diagnostic medical physicists are already familiar with RDIM systems,14 and facilities that already have their fluoroscopes connected to an RDIM may elect to have the RDIM automatically forward RDSR to the TRIAD® Site Server. It is very important if choosing this configuration that the RDIM forward the RDSR without modification. The default behavior of some RDIM systems when exporting RDSR is to “rebuild” the RDSR using information parsed and stored from the original RDSR. In this scenario, fields may be missing, and the Device Observer Name (typically the Station Name) of the creating fluoroscope may be replaced with that of the RDIM, preventing the RDSR from being associated with the correct fluoroscope. Facilities electing this type of configuration are encouraged to contact their RDIM vendor early in the enrollment process to ensure proper configuration and avoid these potential pitfalls. Facilities with the necessary in-house PACS administrator expertise may elect to configure their PACS to automatically forward all RDSR from specific modalities or Station Names to the TRIAD® Site Server. This simplifies fluoroscope DICOM configuration as only a single DICOM destination is needed on each fluoroscope. Further, this destination likely already exists and is used to archive images. It is also possible for the PACS system to forward only to the TRIAD® Site Server or in parallel to the TRIAD® Site Server and an RDIM using this architecture. Any fluoroscope from which the facility wishes to send RDSR to the DIR Central Server must be configured in the TRIAD® Site Server configuration console using the Station Name of the fluoroscope. The Station Name is part of the DICOM metadata (0008,1010), and while it is not a mandatory tag, most clinical imaging equipment populates this tag. The facility is responsible for ensuring that the Station Name has been configured using a unique identifier for all fluoroscopy systems that send RDSR to the DIR. RDSR from systems that are not mapped will be cached on the TRIAD® Site Server for 14 days, after which they will be deleted. Facilities can filter out specific fluoroscopes from sending data to the registry by not configuring these systems in the TRIAD® Site Server configuration console. It is recommended that the Station Name be the only configuration information entered for a fluoroscope, as all fluoroscope configuration information must match for RDSR to be processed by the TRIAD® Site Server. There are numerous failure modes that can interrupt data transfer between a facility and the DIR Central Server. Data validation is a quality assurance process that seeks to minimize interruptions in data transfer, minimize data bias, and maximize data fidelity. Regular data validation minimizes missing time periods, fluoroscopes, or procedure types in the data submitted from facilities to the DIR Central Server. Diagnostic medical physicists are experts in quality assurance and quality control, and can assist in designing appropriate quality assurance processes for data validation. Initial data validation focuses on ensuring that data are being received and processed at the ACR DIR Central Server from all fluoroscopes that a facility intends to connect to the Fluoroscopy DIR. The facility should verify that the full anonymized RDSR, with the Station Name of the creating fluoroscope, is being received from each connected fluoroscope. The “Fluoro/DR Summary of Data Submitted,” “Fluoro Dose Information By Exam,” and “Fluoro Exam Detail” reports, which are available in the DIR Portal, can be used to perform initial data validation. On a regular basis, for example, quarterly, facilities should compare actual procedure volumes to procedure volumes reported in the appropriate facility account(s) for the Fluoroscopy DIR over a specific period of time. If total procedure volumes match and the Station Name of each connected fluoroscope is represented, it is likely that no further comparison is needed. If there is a mismatch, comparisons at the level of Station Name or even Study Description | Requested Procedure Description may be required for troubleshooting. The “Fluoro/DR Summary of Data Submitted” tool in the DIR Portal can be used to perform periodic data validation. One other strategy participating facilities may consider to minimize interruptions in data flow from the facility to the DIR Central Server is to institute process health monitoring. An example of such a process is automated email that the site administrator and diagnostic medical physicist if there is a failure to transfer data from PACS or an RDIM to the TRIAD® Site Server. The local facility informatics will types of site process health can be Facilities that participate in the Fluoroscopy DIR have their facility clinical procedure procedure study for procedures they Clinical procedure mapping is an ongoing process that allows for procedures that are at different sites to be and with other sites by mapping site-specific facility clinical procedure names to a common ACR Common in the of the Fluoroscopy DIR. The Fluoroscopy a fluoroscopy can with procedure and the can provide as detailed knowledge of clinical fluoroscopy procedures is required to map clinical procedures Fluoroscopy DIR participating sites are encouraged to perform mapping at the corporate account level. Clinical procedure name mapping performed at the corporate account level will to all facilities under the corporate account. This requires that any user who or clinical procedure name mapping have the Service User assigned to their user account. Any mapping performed at the facility level will be if a Service User mapping at the corporate account level. Only with a Corporate Administrator or Service User role are to perform clinical procedure name mapping at the corporate account level. 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If a facility to facility clinical procedure names it may be to an mapping between facility clinical procedure names and facility clinical procedure names through your IT Specialist or a systems which can then be used to a of facility clinical procedure name mapping in the Fluoroscopy DIR. 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