Workgroups assessed the current state of radiation services through directed self-reporting and audit by providers, comprehensive review of existing event reports, surveys and site visits, and evaluation of current vendor-provided solutions. This was enhanced by patient safety data from facilities when available, and complemented by a survey of peer-reviewed, evidence-based literature. Best practices from the literature and from facilities were evaluated for their applicability across the entire enterprise.
Development and Implementation of Solutions
The development and implementation of solutions based on workgroup reports are an ongoing organizational goal. All projects are prioritized by the Radiation Right Steering Committee based on potential patient risk as assessed by expert opinion and workgroup recommendations.
Workgroups use information gathered during their assessments to develop initial opinions that are submitted to the Radiation Right Steering Committee. The Radiation Right Steering Committee initiates program development and deployment based on the existing literature, media reports, federal regulations, and workgroup recommendations. The Steering Committee coordinates the development of tools and communication guides with input from leadership, facility-based teams, expert advisory panels, and regulatory agencies (Figure 1). Acknowledgement and approval are obtained from the appropriate workgroups, leadership, and expert panels prior to the development of implementation timelines. Programs are approved by executive leadership and assigned an executive sponsor. Implementation teams are developed based on the work required, with both facility representation and ad hoc subject matter experts. The Steering Committee facilitates communication and continuity of information between the teams as work progresses. The Steering Committee also engages front-line practitioners to aid in the development of solutions in order to maximize practicality and acceptance into the workflow. Individual facilities are engaged to pilot solutions prior to system-wide implementation.
The recommendations and policies developed by the corporate-level workgroups include opportunities for management at the division and facility level. In general, implementation follows the established organizational structure (corporate, division, field). Policies and guidelines are established at the corporate level. Tools and resources are also developed at the corporate level with input from experts in the field. These materials are provided to division leadership for implementation. Division leaders are held accountable for initiating implementation within their facilities and monitoring progress. Responsibility for implementation of individual items is at the facility level. With assistance from division leadership, facility leaders can interpret recommendations, adapt tools, or adjust timelines based on local needs, state regulations, or other factors. Facilities within a division share best practices related to regional characteristics, and all facilities provide feedback to division and corporate leaders. Guidelines were established to observe implementation progress through division monitoring, facility monitoring and tracking, and compliance monitoring.
This comprehensive analysis resulted in (1) the development of standard policies for the use of ionizing radiation, and (2) the identification of six key focus areas for improvement (Table 2). The deficiencies identified, proposed solutions, and the results of initial implementation efforts (Table 3) are discussed for each focus area.
Three company-wide policies were implemented in all facilities that utilize ionizing radiation: Radiation Governance, computed tomography (CT), and fluoroscopy. The Radiation Governance policy expanded and standardized the roles of the Radiation Safety Committee (RSC) and Radiation Safety Officer (RSO) at each facility. Responsibilities of the RSC include monitoring occupational dose policies, approving authorized users and radioactive material usage, approving changes to radiation safety programs, reviewing equipment service records and audit findings, and reviewing all dose quality records to assure ongoing compliance with policies and ALARA principles. The primary responsibility of the RSO is to ensure that all radiation safety activities across the entire facility are performed with approved procedures and meet regulatory requirements. This includes areas outside of radiology (e.g., cardiology services, surgical services, and oncology).
The Radiation Governance policy also included guidelines for equipment service and repair. In brief, equipment is to be tagged “Out-of-Service, Do Not Use” during downtime. This tag offers a process to bridge the gap between the completion of service and the receipt of electronic service documentation, which could be up to 72 hr after completion of service. The field service technician uses this tag to confirm the reported equipment issue, the repair performed, and the recalibration of the equipment to the manufactures original specifications. No equipment can be returned to service until this information is acknowledged by a responsible staff member (e.g., certified technologist, department supervisor, director, or designated representative).
The CT policy set baselines for CT Technologist certification and competency, provided guidelines for the adoption and review of standardized protocols, and established parameters for monitoring, auditing, and reporting radiation dose for CT patients. The fluoroscopy policy established safety strategies to reduce radiation exposure, including privileging and competency expectations, radiation dose thresholds for fluoroscopy, and the development of systems for the monitoring, auditing, and reporting of patient dose.
Focus area 1: Competency and certification
Problem and proposed solutions: Our comprehensive analysis revealed a lack of standardized competency and certification programs as well as a fragmented system of vendor training and basic radiation safety courses (Table 2). Proposed solutions included defined standards for privileging of personnel, competency guidelines that accommodate regulatory requirements, and training standards for field service technicians and physicists. These assure a standard base of knowledge and training within the department.
Implementation and results: The first competency tool designed was for annual assessment of CT technologists. The competencies checklist directs the evaluation of key knowledge points and skills that must be demonstrated before job assignment without direct supervision. This includes reference levels, required documentation, allowable deviation from established procedural protocols, use of shielding, and appropriate equipment settings for specific patient populations and scan types. Competency is evaluated by a combination of observation, proficiency testing, demonstration, or verbalization. Results are recorded for the employee's personnel file and serve as a framework for training, if necessary.
Privileging criteria are currently being established for interventional radiology, electrophysiology, and cardiac catheterization laboratory personnel. As part of biannual privileging, physicians who perform procedures or otherwise utilize radiation (such as interventional cardiologists who use fluoroscopy) will need to complete a course on radiation safety. Course work is being developed by internal and external subject matter experts with additional input from vendors for specific equipment-related skills. These courses will present relevant information and best practices while also meeting all minimum state licensing and certification requirements. Participation in this course, as part of the privileging process, would only be required for those who do not have documented completion of radiation safety education during their residency training.
A challenge facing the implementation of these competency and certification efforts has been variation in educational backgrounds (Table 3). For instance, while the goal is for all technologists that routinely provide radiology services in CT to achieve advanced certification, certain certifications required advanced academic preparation. Individuals without this academic preparation should be accommodated through support for additional training and alternative mechanisms to ensure competency.
Focus area 2: Equipment
Problem and proposed solutions: Installed equipment varies greatly in capabilities and controls. Newer equipment features improved speed and image quality but may increase the risk for harm, either through inadvertent misuse (due to the inherent complexity of the equipment) or accelerated injury (due to the intense amount of radiation that can be delivered). Although software controls can aid in dose control and monitoring, the cost of upgrades can be significant and certain equipment may not accommodate new software. Staff must also be adequately trained to use equipment features, software controls, and upgrades.
There is a need for a more complete understanding of available equipment. This would allow for the development of a standard set of expectations for technology, linked to effective processes and training requirements, which could bolster against risk and allow all providers to meet safety regardless of equipment type (Table 2).
Implementation and results: This analysis utilized the Equipment Risk Assessment Tool—an existing vendor tool that was modified to evaluate the full inventory of current equipment and characterize risk factors. Preliminary data were collected from purchasing records. Facilities received a prepopulated document listing all equipment, and designated personnel validated and updated the inventory list, and answered questions about utilization, including frequency of use and type of procedures. The results were summarized into a report that displayed (1) dose technology (ability to automatically adjust, monitor, and record dose); (2) frequency of high-dose procedures; (3) utilization; (4) useful life of the equipment; and (5) available upgrade options. A portion of this report is presented in Figure 2.
Results were provided to senior leadership promoting discussion and assisting in decision making regarding utilization, dose reduction practices, and capital expenditures. In total, the Equipment Risk Assessment Tool provided an understanding of both equipment abilities and human factors that affect equipment operation. For instance, an older piece of equipment may have a similar level of risk to a newer piece of equipment if used for routine procedures and by a highly skilled operator. This knowledge contributes to the strategic utilization of equipment and related operational and behavioral changes to reduce risk and protect patient safety.
Focus area 3: Monitoring and auditing
Problem and proposed solutions: Although equipment safety controls and procedural guidelines are immensely important, an incomplete understanding of systems capabilities can impede appropriate use of safeguards. In an effort to complete a task, operators may inadvertently circumvent technology and employ creative but unintended use of equipment. Therefore, it is necessary to have mechanisms for monitoring radiation dose at delivery and reporting any irregularities, whether or not patient harm occurred.
Various organizations have proposed evidence-based guidelines or consensus recommendations, such as the appropriateness criteria from the ACR (2011) and diagnostic reference levels from the ICRP (2001). The creation of standard policies and guidelines for auditing and monitoring, as well as increased internal reporting, were proposed (Table 2).
Implementation and results: Currently, monitoring is a manual process due to technology constraints. The dose delivered to the patient is monitored for appropriateness based on ordered exam, with quality assurance processes to verify that the best image is produced using the lowest dose of radiation. Guidelines for acceptable performance have been established, and the process is supported and verified by internal survey and audit teams. The long-term goal is to integrate automated systems for dose reporting and cumulative dose reports into standard care processes, which could allow physicians and providers to monitor outcomes, better plan for future care, and have informed discussions of risk with patients. Several products are currently being pilot tested and the results will be shared with the vendors to improve the design and development of automated solutions.
Modifications were made to the existing event reporting system to encourage the reporting of events related to radiation safety and provide additional information about risk. Corporate clinical leaders updated guidelines to clarify what types of events are considered reportable. This included defining reportable variances in dose limits for fluoroscopy; additional guidelines will follow as dose limits are determined for different modalities. Division and facility leadership were encouraged to reinforce reporting behavior and to provide training for personnel in the event reporting process.
Focus area 4: Education
Problem and proposed solutions: Although radiologic technologists viewed the presentations offered by vendors and knowledge leaders as a useful review of techniques and equipment use, this analysis revealed the need for coherent educational processes with adequate oversight and a defined curriculum. In addition, there was a need for additional instruction on specific aspects of radiation safety, including dosing and advanced equipment usage.
Accordingly, clinical experts and vendors coordinated to design educational courses for radiation safety. These courses present topics such as new practices, event reporting, protocols, and physicians’ roles in fostering a culture of safety at the unit level.
Implementation and results: Educational programs were developed by external subject matter experts, internal technical experts, and relevant technology vendors. The programs were tailored to specific specialties and designed for economy and consistency across practice areas. Materials were produced in a variety of formats—from online webcasts to recorded instructor-led presentations—to meet audience needs.
In retrospect, previous vendor-provided training courses had several limitations, including inconvenience (e.g., travel to vendor site, weekend training), little ability to track participation, and no universal curriculum. The consolidation of training courses to a centralized online education system both standardized content with the most current evidence and reduced employee burden by allowing them to participate whenever their work schedule allowed.
Currently four courses have been deployed with a total of 2,100 completions. These courses provide CE credit as applicable in order to help technologists meet requirements for continuing education. Future plans include educational courses with CE or CME credit, courses specific to equipment operation, and education sessions targeted to particular groups, such as referring physicians. The first course with CME credit was launched at the end of 2012. This course was designed for physicians who perform fluoroscopy, with the ultimate goal of integrating it into privileging criteria at the facility level.
Focus area 5: Clinical pathways
Problem and proposed solutions: The tracking of radiation dose and patient exposure in electronic health records would help physicians and prescribers develop appropriate care plans that consider the necessity of particular tests. The utility of such systems has been shown by various providers, such as the pioneering efforts by Massachusetts General Hospital to send alerts based on collated dose (Massachusetts General Hospital, 2012).
Creating radiation-specific order sets that are available, appropriate, and offer alternatives to high-dose procedures is an institutional and provider responsibility. These order sets should be evidence-based and informed by the dose range for the intended test as well as patients’ prior exposure. System developers should be prepared to incorporate and respond to current and future regulatory requirements, such as the imaging efficiency measures being developed by CMS (Magellan Health Services, 2010).
Implementation and results: The previously described policies for CT and fluoroscopy included recommended protocols as a preliminary step toward evidence-based order sets. Physician advisors encouraged adoption of these protocols within facilities, using event reporting and available data to drive awareness of risk and the potential effect on patient safety. In this way, the existing manual data system was leveraged to monitor and evaluate the entire patient experience, from determining if care was appropriate to reacting to outliers. The implementation of these recommended protocols also brought forth several issues that could affect the success of Computerized Provider Order Entry (CPOE) and evidence-based order sets, including variability in equipment and the clinical preferences of radiologists.
Order sets will be designed by physicians and multidisciplinary experts to maximize acceptance and address current needs. When automatic data collection is fully developed, the CPOE system will provide physicians with current patient characteristics and history, including exam frequency and dose, at the time of exam ordering. The development of order appropriateness guidelines, including criteria for ordering pathology-specific procedures, is an ongoing project.
Focus area 6: Communications and marketing
Problem and proposed solutions: The importance of these proposed solutions must be communicated to key stakeholders including leadership, clinicians, technicians, patients, and the general public. Accordingly, communication and marketing strategies to promote radiation safety were developed. Dubbed “Radiation Right,” these campaigns presented a consistent safety message to all stakeholders.
Implementation and results: The communication campaign for imaging featured the tagline “Right Exam. Right Site. Right Dose.” Materials were specifically designed for staff, patients, and the public with messaging about safety efforts including dose reduction, dose tracking, and equipment maintenance. For patients, this included materials to increase awareness about their responsibility for ensuring radiation safety, such as telling care providers about their previous radiation exposure history. Additional materials for technologists, physicians, and staff displayed updates in regulatory requirements or provided reminders of imaging alternatives. A similar campaign was also developed for therapeutic radiation.
With corporate guidance, one division created and piloted a “Radiation Right” webpage to be presented as a community educational resource on the publicly available websites for each facility within that division. The webpage was designed to be easily adapted to any facility and featured educational messaging about the use of ionizing radiation and radiation safety efforts. A social marketing vendor was engaged to post articles on social media sites with links to facility websites for more information. This concerted campaign effort by all facilities within the division may have increased its effectiveness; postcampaign feedback from physicians and staff indicated that patients had fewer questions and concerns regarding radiation through imaging. In addition, using social media to drive patients to facility websites capitalized on publicity due to concurrent reports of radiation overexposure in the lay media. The template for this webpage has been offered to all facilities, and is fully implemented within eight divisions.
The broad availability and high utility of ionizing radiation services have desensitized providers, prescribers, operators, and even patients to the associated risks and potential for harm. This presentation of areas for improvement, proposed solutions, and initial implementation efforts provide a framework for minimizing risk through the development of appropriate processes, utilization of available technology controls, and the creation a culture of safety.
The broad and comprehensive scope of our assessment confirmed the complexity involved in providing high-quality, safe, effective, and efficient delivery of ionizing radiation. We expect that all our proposed solutions will ultimately build upon each other. For instance, upgraded equipment and software will require knowledgeable operators as well as dose standards and tracking of patient exposure. The consolidation of educational courses into a centralized online system will help eliminate many of the barriers to training, creating a better educated workforce that is more able to safely operate equipment and evaluate the appropriateness of ionizing radiation. Increased availability of patient radiation histories could lead to more informed decision making and ordering, potentially reducing the tendency to overprescribe scans, especially in the context of “defensive medicine.”
Yet these changes will not be possible without the support of stakeholders from throughout the ionizing radiation delivery process. The Radiation Right Steering Committee was essential to coordinating this process and eliminating barriers to communications between various groups. The inclusion of experts from all levels of the organization enabled the proposed solutions to reflect the practical needs of the field and include the most up-to-date regulatory and evidence-based practice requirements. The solicitation of feedback and guidance by the Steering Committee improved communication and collaboration that was crucial to the success of the proposed solutions. Input from physicians and other clinical experts supported the development of privileging requirements and encouraged adoption within facilities. Similarly, leadership support was vital. This was cultivated by providing open access to data, soliciting and responding to feedback, and allowing for flexibility in implementation to meet local needs. Finally, many of the proposed solutions, from equipment repair policies to ongoing personnel training, depend on maintaining an effective working relationship with vendors. Facilities are conducting pilot tests and providing feedback to help vendors develop products that are evidence-based, appropriate to the workflow in various environments, and include the required process checks, such as dual sign-offs on dose calibration.
With continued process improvement, further reductions can be made in radiation dose while still providing high-quality diagnostic exams to the radiologist. Sharing this information with a national database can effectively drive new industry standards. Future efforts will refine the collection, monitoring, and utilization of data. Automatic data collection will expand availability of information about the patient experience and allow for integration with CPOE. Radiation dose tracking systems will need to be designed and implemented, with attention to the goals and guidelines for health information technology that result from national standards-determination processes (U.S. Department of Health and Human Services, 2009). Additional considerations include state regulatory requirements for radiation controls through equipment maintenance and monitoring policies as well as the establishment of databases for the tracking of delivered doses, such as those required by the California legislature (California State Legislature, 2010). The solutions presented here will continue to evolve with additional state legislation and changing regulatory requirements.
The facilities involved may have benefited from resources inherent to a system as large and interconnected as ours, such as access to training materials or assistance with vendor negotiations. Although some challenges are universal, such as variability in equipment and the need to evaluate rapidly emerging vendor products, our implementation of proposed solutions benefited from the ability to move equipment and technology purchasing toward a centralized system. It should be noted, however, that the integration of these system-wide benefits was dependent on local support and acceptance of the proposed solutions. As facilities within this system are highly diverse, primarily community-based hospitals in a variety of locations, it is likely that the findings presented here would be applicable to a wide range of unaffiliated facilities.
Implications for Practice
In order to maximize risk reduction, the solutions developed as a result of this analysis focused on forcing functions, automation of processes, and standardization when possible (Reason, 1997). Higher level solutions such as dose monitoring, software controls, and standard protocols were preferred. As our evaluation demonstrated, maximizing the safety of ionizing radiation delivery will require such interventions due to the inherent complexity of the processes involved. These efforts could also improve patient satisfaction, as improved access to protocols and patient data could reduce provider workload, allowing more time for patient–provider interaction and care planning.
However, these high-level solutions were not always feasible due to factors such as technology limitations and the cost of equipment upgrades. Accordingly, solutions related to the human factors involved in care delivery, such as checklists, policies, and education, were necessary to foster a culture of safety. Efforts to change attitudes and behaviors, such as education and communication campaigns, complement these strategies. As the identified areas for improvement cross a variety of functions, the importance of cooperation from leadership, providers, and vendors cannot be overemphasized. All personnel must be empowered—and expected—to voice their concerns and contribute to creating an open and constructive culture of safety.
In total, improvements in the quality, safety, effectiveness, and efficiency of ionizing radiation use for patient care are possible and achievable. A comprehensive review of radiation policies, procedures, and utilization can identify potential areas for improvement where more robust and systematic layers of processes could reduce the risk of harm. By maintaining diagnostically useful examination while minimizing harm, providers can fulfill their responsibility to provide the best possible care for patients when using ionizing radiation.
The authors wish to acknowledge the following individuals for their contributions: Kimberly Korwek, PhD, manuscript preparation and editing; Jane Englebright, PhD, RN, document revision; Anthony Roberts, RN, MBA, MSN, CCRN, Jason Hickok, MBA, RN, Barbara Olson, MS, RN, FIMSP, and Tamithia Winn, ARRT (R)(CT), ARDMS, expert guidance, technical review, and document revision; Jill Fainter, technical and standards review; Joseph Haase, technical and document review; Cathy Florek, Rita Baldwin, Stephen Slack, MD, Michael F. Scott, RT, MBA, Dennis Watts, Jenine Hilton, Andrew Trovinger, In K Mun, PhD, and Kim Harrison, data acquisition, interpretation, and technical review; Steven Manoukian, MD, data review and expert guidance; Cindy Borum, data review; Kathryn Mitchell, patient safety culture and reporting guidance; Carol Corder, Crockett Boone, and Chuck Nagel, technical and data review; Kristen Barber, project management; Patrick Hoye, technology review; Susan Goodwin, privileging guidance. Additional consultation on components and document review was provided by the Medical Imaging Steering Committee and the Radiology Physician Advisory Council.
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Jonathan B. Perlin, MD, PhD, MSHA, FACP, FACMI, is the President of the Clinical & Physician Services Group, and Chief Medical Officer of HCA.
Laura Mower, MS, is the Vice President of Outpatient and Ancillary Services of the Clinical Services Group of HCA.
Chris Bushe, MSHA, MT(ASCP), is the Director of Laboratory Services of the Clinical Services Group of HCA.
Keywords:© 2015 National Association for Healthcare Quality
ionizing radiation; patient safety; process improvement; systems improvement