RO-ILS: Radiation Oncology Incident Learning System^®, is a free, online safety tool tied to a patient safety organization, with accompanying confidentiality and privilege protections outlined in the federal Patient Safety Act. The mission of RO-ILS is to facilitate safer and higher quality care in radiation oncology by providing a mechanism for shared learning in a secure and non-punitive environment.

This program is open only to U.S.-based practices. Enrolled practices receive access to a unique instance of the RO-ILS Portal where they enter a wide-range of safety events, analyze their trends and send data to a national database. Safety experts mine the national database and develop education for the radiation oncology community.

PSOs are federally recognized entities that collect information about medical errors and safety risks in a confidential and protected environment. The goals of PSOs and incident learning systems are to reduce errors, improve quality and promote safety. PSOs can be national, state-based, specialty-specific or broadly applicable. Currently, there are more than 90 PSOs listed with the Agency for Healthcare Research and Quality (AHRQ).

RO-ILS is a radiation oncology-specific program associated with Clarity PSO, one of the first PSOs federally-listed by AHRQ.

ASTRO partnered with the American Association of Physicists in Medicine (AAPM) to develop RO-ILS and, together, sponsor the program. ASTRO contracted with Clarity to develop the incident learning system platform and provide PSO services to interested radiation oncology practices. Clarity PSO is a division of Clarity Group, Inc., a health care professional liability risk management organization and neither is affiliated with ASTRO. They are independent entities providing the necessary RO-ILS services to radiation oncology professionals.

ASTRO serves as the gateway for providers interested in RO-ILS participation. ASTRO receives financial support from AAPM, Varian Medical Systems, Inc., the American Society of Radiologic Technologists (ASRT), the American Association of Medical Dosimetrists (AAMD) and Sun Nuclear Corporation, for the operation of RO-ILS.

RO-ILS helps practices improve the quality of care for their patients and make processes safer. It also helps improve safety culture, better communication and build a collaborative team dedicated to assessing ways to increase effectiveness and efficiencies.

Enrollment and participation in RO-ILS provides a host of additional benefits. Radiation oncology practices and staff:

• Contribute to a national database and collectively improve the field of radiation oncology.
• Track and review internal incidents, near misses and unsafe conditions.
• Receive legal protections from discovery afforded by the Patient Safety Act for information that meets necessary requirements.
• Receive regular education based on events reported throughout the country, including suggestions on how to prevent errors.
• Receive practice-specific reports.
• Gain access to analysis tools within the RO-ILS Portal.
• Receive regular program education and announcements about features and tools, best practices and general patient safety initiatives.
• Learn from RO-ILS user meetings and webinars.
• Meet the requirements for up to two Improvement Activities in Medicare's Merit-based Incentive Payment System (MIPS).
• Meet the requirement to participate in a PSO within the radiation oncology alternative payment model (i.e., the “RO Model”).
• Meet components of accreditation programs, including ASTRO’s APEx^® program.
• Meet criteria for a practice quality improvement (PQI) toward the purpose of fulfilling requirements in the ABR Maintenance of Certification (MOC) Program.

To indicate interest in the program and begin the enrollment process, download the RO-ILS Participation Guide and submit a completed Enrollment Form to Clarity PSO.

Enrollment is then divided into three stages:

• Contracting: A practice must first contract with Clarity to establish the protections afforded by the Patient Safety Act. Practices enter into a PSO Provider Service Agreement and a Business Associate Agreement with Clarity PSO.
• Onboarding: Practices then receive on-demand trainings, designate local staff leaders, customize selected sections of the Portal and establish local policies and procedures.
• Implementation: Lastly, the practice incorporates RO-ILS into existing processes and deploys the program to all staff.

Clarity staff will guide practices through enrollment and is available for extra support at all stages.

There is no cost to practices for enrolling or participating in RO-ILS.

ASTRO can offer this program free of charge thanks to financial support from sister societies, including AAPM, ASRT and AAMD, as well as from vendors Varian Medical Systems, Inc. and Sun Nuclear Corporation.

A practice can comprise just one or multiple facilities. Facilities are distinct clinical sites situated in different locations (e.g., satellite clinics). Since the RO-ILS Portal is web-based, it is easy to deploy one shared system across an entire health network and eliminate data silos. Practices can benefit from data aggregation and improved analytic capabilities by identifying unique and shared data trends across different facilities within their network.

To enroll a multi-facility practice, the parent organization that owns, manages, or oversees the facilities will need to contract with Clarity PSO. Clarity PSO will work with you to determine the plan that best meets the needs of your institution. Clarity will also adapt the onboarding and implementation phases of enrollment as appropriate for the size of your practice.

In total, complete enrollment from contracting to implementation takes approximately four to six months.

The median time to contract for private/community-based practices is roughly two months, compared to four-and-a-half months for academic/university practices. When users were asked about delays in contracting, most indicated that the postponement was internal.

The median time for on-boarding for both academic and private practices is less than two months.

Yes. A practice can participate in more than one PSO. There is no limit to the number of PSOs a practice works with. Therefore, many practices have a hospital- or institution-wide PSO that focuses on medication errors, falls etc. and RO-ILS, which collects radiation oncology-specific information.

As a default, RO-ILS enrollment and participation is confidential; however, many practices have agreed to publicly announce their enrollment in the program. Practices that have given Clarity PSO and ASTRO permission to publish their names are included on the RO-ILS listing. If your practice is enrolled and would like to be listed, please contact RO-ILS staff.

As the RO-ILS program has grown and matured, the format of RO-ILS education has also evolved. The Radiation Oncology Healthcare Advisory Council (RO-HAC) develops RO-ILS education based on analysis of the national database managed by Clarity. Initially, RO-HAC released quarterly reports based on a quarter's worth of events. Starting in 2018, RO-ILS began transitioning to multiple educational items to better harness the large amount of data in the national database and get information out to the radiation community in a more timely fashion. This includes:

• Safety Notices: A safety notice communicates findings that may be novel to the community, of higher clinical significance and/or deserve more prompt review.
• Case Studies: These stand-alone case studies summarize one RO-ILS event and provide learning, feedback and suggestions from RO-HAC.
• Themed Reports: Focused on various topic areas, themed reports transcend the entire RO-ILS database and include multiple case examples.
• Aggregate Data Reports: These reports provide a high-level look at the trends in the national database and include a “report card” and graphs.

When possible and needed, RO-ILS seeks to engage the practice that reported the event in an open dialogue and development of education. With Clarity PSO working as an intermediary, practices who agree to collaborate are given the option to remain anonymous and provide feedback on education prior to release.

Yes. This includes the Analysis Wizard and Dashboard within the RO-ILS Portal.

The Analysis Wizard gives Reviewers the ability to develop custom reports, graph results and create templates. The Reviewer determines the parameters for the report based on all the data elements within the RO-ILS Portal and organizes the information as needed (e.g., filter, sort). The results can be exported to spreadsheet/PDF and graphed. Report templates can be saved for future use, and a scheduled report can be set to automatically run the report and send the results to one or more Reviewers.

The Dashboard gives Reviewers up-to-date charts on key information. The data displayed in the Dashboard is a snapshot of trends and is automatically updated every evening. The content and format of the Dashboard is standardized for all RO-ILS practices, but templates can be leverage and copied in the Analysis Wizard. By clicking on any portion of a graph, the user will find a summary of associated events and can view all the event details.

Since its inception, RO-ILS has worked to meet patient safety components of accreditation programs.

RO-ILS can be utilized to satisfy most evidence indicators with ASTRO’s Accreditation Program for Excellence (APEx) Standard 7. This standard assesses that the practice fosters a culture of safety in which all team members participate in assuring safety, the practice capitalizes on opportunities to improve safety, and no reprisals are taken towards staff who report safety concerns. RO-ILS enables the collection of all types of safety events (with the option of anonymity), analysis and identification of local trends, creation of reports to facilitate discussion at internal safety meetings and reporting events to a national PSO.

RO-ILS also can help meet the National Accreditation Program for Breast Cancers (NAPBC) Standard 6.1. This standard on quality and outcome specifies that breast centers must conduct or participate in a minimum of one in-house project and either another local project or a specialty-specific quality improvement program each year. RO-ILS is now an approved quality improvement program for the NAPBC. RO-ILS practices will need to collect breast-specific events to show compliance.

RO-ILS helps meet requirements in the Centers for Medicare and Medicaid Services (CMS) Quality Payment Program (QPP). The QPP is split into two major branches: the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Participation in QPP can significantly impact a practice’s Medicare Part B reimbursement, positively or negatively, based on performance.

One category of MIPS is “Improvement Activities.” A medium weighted activity in this category is “Participation in an AHRQ-listed patient safety organization.” Clarity PSO is an AHRQ-listed PSO; therefore, participating in RO-ILS meets this activity. Another medium weighted activity for MIPS is participation in Maintenance of Certification (MOC) Part IV. This could be met with the RO-ILS Part IV Physician Quality Improvement (PQI) template.

The radiation oncology APM, better known as the “RO Model,” was delayed to a date to be determined in a future notice of proposed rulemaking. A requirement of the RO Model is participation in a PSO, which is met by RO-ILS. RO-ILS practices contract and engage with Clarity PSO which is listed by AHRQ.

Contact Clarity IT at support@claritygrp.com or 773-864-8298 for support accessing your RO-ILS Portal. It is important to note that there is not one shared RO-ILS Portal weblink. Each practice has its own unique URL to the RO-ILS Portal for extra security and assurances when anonymously reporting an event within a practice. ASTRO does not have access to any practice’s unique URL. For tips on how to properly save the unique URL, read the Portal Bookmarking and Desktop Shortcut program document.

Contact Clarity IT at support@claritygrp.com or 773-864-8298 and clarify if you need login information for the Submitter or a Reviewer account.

The Submitter account is one shared username and password for all staff within the practice to perform initial, front-line submission of events. This shared generic login provides extra security while allowing staff to submit an event anonymously.

Reviewers are designated representatives within the practice who will review local events and enter follow-up analysis in the “My Review” section of the Portal. These individuals have their own unique login information.

ASTRO does not have access to any user login information.

Determine the unique role(s) the individual played in your local RO-ILS effort and take the necessary steps. If the individual was the designated PSO Liaison or Authorized Representative, contact Clarity PSO at radoncsupport@claritygrp.com or 708-667-7730 to assign a new individual to that role. If the staff member was a Reviewer, complete the RO-ILS Reviewer Request Form to remove their access to your RO-ILS Portal. If they simply submitted events to RO-ILS, no specific action is required.

The new staff member will need to be on-boarded to RO-ILS similar to all staff during implementation. Be sure to provide the individual with a copy of the RO-ILS Overview and Submitter video, written program documentation and practice-specific login information. If the staff member will become a Reviewer, provide them with the Reviewer-specific resources and complete the RO-ILS Reviewer Request Form to create their account.

To add one or more new facilities to an existing, contracted RO-ILS practice, complete a Facility Request Form. The practice’s designated PSO Liaison will need to approve and sign the form. Send the completed form to Clarity PSO at radoncsupport@claritygrp.com.

Users can view the RO-ILS Portal in a web browser on a computer or on a mobile device running Windows, iOS, or Android OS. No application needs to be installed on local computer systems or mobile devices.

The RO-ILS Portal is best viewed in Chrome and Internet Explorer version 11.0 and higher.

The typical RO-ILS process of event reporting is:

1. An event is discovered.
2. Any staff member logs into the Portal with the shared “Submitter” account and completes the “Submit Event” form. The shared “Submitter" account allows for anonymous submission.
3. Reviewer(s) receives an automatic email notification of submission. Reviewers are designated representatives within the practice who will review and manage local events.
4. Reviewer(s) completes the practice’s internal protocol for investigating the event, which may vary depending on the severity of the event.
5. Reviewer(s) completes the “My Review” section of the Portal.
6. Reviewer(s) reports the event to the PSO.
7. A copy of the event is sent to the national PSO database. If there are any changes to the event in the local, practice-specific database, it is automatically updated in the national database.

All staff within the radiation oncology practice, including radiation oncologists, medical physicists, dosimetrists, nurses, radiation therapists, trainees and practice administrators, can enter data into RO-ILS.

The “Submitter” account is one general login that should be shared with all staff. Utilizing the Submitter account, any staff member can access the RO-ILS Portal and complete the initial, front-line reporting form (i.e., the “Submit Event” form).

“Reviewer” accounts are specific to one individual within the practice, with a limit of 10 Reviewers per facility. Reviewers enter follow-up analysis in the “My Review” section of the Portal and report the event to the PSO. They also have access to the Analysis Wizard and Dashboard within the Portal to support the practice’s work in identifying trends. The practice initially chooses who will be Reviewers during on-boarding, but this can be changed at any time.

Within the “My Review” section of the Portal, there is a required question that asks Reviewers, “Do you want to report this event to the PSO?” “Yes” is auto selected, but users are given the option to actively change the answer to “No.” Reporting an event to the PSO does not limit your ability to add additional information. It does strengthen the national RO-ILS database and help meet some of the criteria for patient safety work product-associated with the confidentiality and privilege protections. Reviewers can easily see which events have been reported to the PSO in the “My Review Table,” review overall trends in the Dashboard and generate a specific report in the Analysis Wizard.

RO-ILS can be utilized to collect any kind of event. RO-ILS event classification includes:

• Therapeutic Radiation Incident: Radiation dose not delivered as intended, with or without harm.
• Other Safety Incident: Event that reached the patient, not involving radiation dose, with or without harm (e.g., collision, fall).
• Near miss: A safety event that did not reach the patient.
• Unsafe condition: Any condition that increases the probability of a safety event.
• Operational/Process Improvement: non-safety event.

A lot can be learned from submitting, reviewing and analyzing a variety of events, and for this reason, practices are encouraged to enter all events into RO-ILS. There is no limit on the type or number of events that can be reported to Clarity PSO.

ASTRO has published online the complete list of RO-ILS data elements associated with events. The RO-ILS Portal is divided into two sections.

The “Submit Event” form includes fewer than 10 questions about the event and typically takes only a few minutes to complete. This is where the Submitter describes the event, determines the event classification, identifies the treatment technique and chooses if they would like to include their name.

The “My Review” page includes more detailed questions about the event, such as the workflow step where the event occurred and was discovered, significance to patient safety and problem type. Extensive branching logic reduces the total number of questions that may appear for a given event. For example, dose deviation will only appear for events classified as “Therapeutic Radiation Incidents.”

No, RO-ILS does not require submission of patient protected health information (PHI), Nevertheless, all practices participating in RO-ILS enter into a business associate agreement (BAA) as defined by the Health Insurance Portability and Accountability Act (HIPAA) with Clarity PSO prior to reporting any safety information. In the event PHI is submitted to RO-ILS or reported to the PSO, the HIPAA requirements for sharing PHI are met.

The only patient-specific data elements in RO-ILS are patient’s age (as a range) and gender. Both data elements are optional and include an answer option of “unknown” or “report not patient related.” These data elements were selected based on guidance from AHRQ, which developed “common formats” to facilitate standardization of data collection and aggregation across all PSOs. RO-ILS collects less patient-specific information than AHRQ common formats.

Currently, there is not a mechanism to map and transfer data from existing incident learning systems to RO-ILS. However, ASTRO is exploring a pilot project to test the feasibility of an application programming interface (API) to support electronic data transfer to RO-ILS.

There already exists a mechanism in the RO-ILS Portal for RO-ILS users to download and export their data to a PDF or spreadsheet.

Enrolled practices have their own local practice-specific database. When an event is submitted to RO-ILS, it is only in the local database. Staff who only have access to the practice’s Submitter account cannot see any other events from the practice; only Reviewers can do so. Reviewers only have access to their practice’s own local database. They cannot view another practice’s data nor the national database. Once a Reviewer has reviewed the event and indicated that the event should be reported to the PSO, a copy of the event is sent to the national database managed by Clarity.

The national database is analyzed by Clarity and RO-HAC. In compliance with HIPAA and the Patient Safety Act, Clarity and the individual RO-HAC members are bound by confidentiality provisions that protect the confidentiality of identifiable data that is shared. ASTRO can view only select aggregated data and non-identified event descriptions.

No. Information shared outside of RO-HAC is always “non-identified.” As defined in the Patient Safety Act, this means that it is stripped of identifying elements, including information that could identify the practice, patient and/or health care providers. Aggregate trends from the national database and non-identifiable description of events are shared with the radiation oncology community in a variety of educational formats to promote learning on a national level.

Enrolled practices may query their own local database. The RO-ILS Portal includes the Analysis Wizard as a tool to support local data analysis. In order to protect the confidentiality of enrolled practices and events, the national database managed by Clarity cannot be queried at this time. Should you have a suggestion for a future RO-ILS educational topic, please send an email to roils@astro.org.

The Radiation Oncology Healthcare Advisory Council (RO-HAC) is a group of 12 radiation oncology professionals who provide subject matter expertise to RO-ILS by conducting data analysis on the national dataset and developing education for the community. RO-HAC is interdisciplinary and includes radiation oncologists, physicists, dosimetrists, therapists and administrators. These patient safety experts receive an honorarium and must sign a Business Associates Agreement and an Independent Contractor Agreement with Clarity PSO before accessing any data. The RO-HAC operates as part of Clarity PSO's patient safety evaluation system and is not subject to either ASTRO or AAPM review or oversight. Members must comply with ASTRO's Conflict of Interest Policy for RO-HAC.

RO-HAC members have access to the events reported to the PSO and actively review events that are deemed high priority according to an objective, automatic triage mechanism. Based on information entered by RO-ILS users, the triage process identifies events worthy of individual human review.

RO-HAC members are deemed independent contractors of Clarity PSO and, therefore, work within the PSO’s protected environment and are subject to the same confidentiality and privileged protections of information. Nevertheless, RO-HAC does not have access to all data elements provided by the user. For example, RO-HAC is not provided any of the location information (#101-103) which would indicate the practice or facility name, nor specific dates and times surrounding the event, submission and reporting. RO-HAC also does not have access to the Local ID (#107), Reporter’s Name (#108) and data element dedicated for Internal Use (#229). If the user includes identifiable information in the free text fields, such as the event Narrative (#104), RO-HAC will see that information.

When there are opening(s) on RO-HAC, ASTRO and relevant sister societies will issue a call for volunteers. Individuals interested in serving on RO-HAC will complete an application and ASTRO’s Statement of Disclosure. More information about the RO-HAC qualifications, responsibilities and requirements can be found on the RO-HAC webpage. A call for volunteers is posted on that webpage, typically in July or August, if there are open position(s) for the following year.

RO-HAC members are selected by the leadership of ASTRO’s Clinical Affairs and Quality Committee with input from supporting associations, as needed. Based on the ASTRO Statement of Disclosure, relationships and interests will be reviewed to determine if they pose a conflict of interest, which may disqualify an applicant. Selected applicants will serve a two-year term with opportunity for renewal. Members can serve a maximum of three terms, for a total of six years.

The web-based RO-ILS Portal is hosted within Clarity’s network and was developed on Clarity’s Healthcare SafetyZone platform. From an implementation standpoint, the Portal is used over an SSL connection (Port 443). No servers are required for the users. The environment at Clarity is Microsoft Server Farm operating the .NET environment using SQL Server as the database. None of these components are installed at your location. This is a Software as a Service application. Clarity monitors and maintains the scalability of the database.

Clarity maintains proper firewalls, such as Cisco firewall and Cisco switch, on Windows 2017 servers. Incremental data are backed up hourly, and full backups are performed each night and backed up offsite with three months of backups retained. Additionally, the data center is physically secured and monitored throughout the day for performance, health and security.

Clarity engages in compliance activities as required by HIPAA and its privacy, security, breach notification and enforcement regulations and the U.S. Health and Human Services Office for Civil Rights. These activities include:

• Annual, and more frequently if indicated, HIPAA education and training to Clarity employees.
• Annual HIPAA education to subcontractors.
• Signed business associate agreements with clients, business associates and subcontractors.
• Internal processes and committees to facilitate HIPAA compliance (e.g., risk assessments, policies).

Clarity utilizes a lockout feature to secure the electronic session after 20 minutes of inactivity within the Portal. In addition, Clarity has a HIPAA security team that meets monthly to review policies and procedures relating to any incidents with the Portal. Clarity also has obtained an SSAE SOC 2 Type 1, available upon request.

The Patient Safety and Quality Improvement Act of 2005, also known as the Patient Safety Act or PSQIA, is a federal law that allows providers to examine and to learn from patient safety events in a protected environment. Congress passed the law in response to the 1999 Institute of Medicine report “To Err Is Human.” The law authorizes patient safety organizations (PSOs) to confer certain privilege and confidentiality protections.

Clinicians and health care organizations can voluntarily report, investigate, aggregate and analyze data within a PSO with the goal of reducing the risks and hazards associated with patient care. Practices are required to sign a contract with a federally-listed PSO prior to reporting information in order to obtain the legal protections outlined in the Patient Safety Act.

Information that qualifies as patient safety work product (PSWP) is given privilege and confidentiality protections against disclosure and discoverability by the Patient Safety Act, except in limited circumstances. PSWP is defined in the federal regulations at 42 C.F.R. § 3.20. PSWP can be any data, reports, records, memoranda, analysis (such as root cause analysis) or written or oral statements (or copies of any of this material) that could improve patient safety, health care quality or health care outcomes. PSWP is, essentially, the information that is developed through the deliberative process created by the provider to collect and submit information for review by a PSO.

Not all information can become PSWP. A patient’s original medical record, billing and discharge information, or any other original patient or provider information cannot be protected as PSWP, even though elements of all those documents might be extracted or incorporated into the data set that is submitted for a safety review of an incident involving that patient. In addition, information that is collected, maintained or developed separately, or that exists separately, cannot be considered PSWP.

There have been some legal challenges to the Patient Safety Act in state and federal courts. In general, these challenges have focused on gaining access to information that was required to be reported to a state or required by the state to be recorded (even if that information was not shared with the state). In response to questions raised about the protection of materials prepared to fulfill external obligations (e.g., state and federal reporting or recording keeping requirements), HHS issued additional guidance in 2016. Practices should review and understand the reporting and recordkeeping requirements in their state, as this will impact what information can be PSWP.

To date, none of the legal challenges have focused on radiation oncology or RO-ILS data. ASTRO and Clarity continue to monitor these cases and, where possible, participate in amicus curiae (friend of the court) briefs in favor of greater protection for PSWP and the Patient Safety Act.

The Agency for Healthcare Research and Quality (AHRQ), a division of the U. S. Department of Health and Human Services (HHS), oversees the activities and compliance of federally-listed PSOs. Approved PSOs, such as Clarity PSO, which hosts RO-ILS, are listed on the AHRQ website. The HHS Office for Civil Rights (OCR) oversees the confidentiality compliance of federally-listed PSOs.

Reporting to RO-ILS does not replace other reporting requirements placed on a practice, and, therefore, practices must still comply with respective reporting requirements. Practices are subject to reporting requirements imposed by the federal government (e.g., the Nuclear Regulatory Commission), state and local agencies (e.g., departments of health) and often by their own institutions. To understand the relationship between reporting requirements and what information may be protected under the Patient Safety Act, review the HHS 2016 guidance on how and what information can be protected.