The PSQIA is a federal law that allows providers to examine and to learn from patient safety events or incidents without fear of liability. The law authorizes patient safety organizations (PSOs) where licensed health care providers can report safety events in a confidential and privileged environment. Providers are required to sign a contract with a federally qualified PSO prior to reporting information in order to obtain the legal protections outlined in the PSQIA.
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, are listed on the AHRQ website. The HHS Office for Civil Rights (OCR) oversees the confidentiality compliance of federally listed PSOs.
Radiation oncology practices must sign a contract with Clarity PSO to participate in RO-ILS. To begin the contracting process, complete the Participation Form (Appendix F) and submit to Clarity PSO. For additional information on the process for participation, please download the Participation Guide from the ASTRO website.
Any licensed health care provider who contracts with Clarity PSO and reports events into RO-ILS must still comply with any of your respective state or federal mandatory reporting requirements.
Yes, there have been legal challenges to the confidentiality and privilege protections of the PSQIA. ASTRO and Clarity PSO both continue to monitor these challenges and will communicate developments with users. For the most recent information, please check the ASTRO website.
ASTRO serves as the gateway for providers interested in RO-ILS participation. ASTRO contracted with Clarity PSO to develop the incident learning system 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. Neither Clarity PSO nor Clarity Group, Inc. is affiliated with ASTRO; they are independent entities providing PSO services to ASTRO members and other radiation oncology professionals.
In addition to ASTRO, the American Association of Physicists in Medicine (AAPM) also sponsors RO-ILS by contributing financial and program support. ASTRO also receives financial support from Varian, Elekta, humediQ, Sun Nuclear Corporation, the American Society of Radiologic Technologists (ASRT), and the American Association of Medical Dosimetrists (AAMD) for the operation of RO-ILS
Three physicians and four physicists served on the ASTRO-AAPM joint steering committee to oversee the initial development of the data elements and educational material for RO-ILS.
RO-HAC is a group of radiation oncology professionals who provide subject-matter expertise, including helping Clarity PSO analyze, interpret and report on data submitted into RO-ILS. RO-HAC members include radiation oncologists, physicists, dosimetrists and other patient safety experts. Members of RO-HAC receive an honorarium for their service on the RO-HAC and must sign a contract with Clarity PSO before they may have access to the data. The leadership of ASTRO’s Clinical Affairs and Quality Council, with input from AAPM’s Working Group for Radiation Oncology Incident Learning System (WROILS), determines and appoints members to RO-HAC. The RO-HAC operates as part of Clarity PSO’s patient safety evaluation system (PSES) and its activities are not subject to either ASTRO or AAPM’s review or oversight.
ASTRO, with the help of AAPM, will issue a "call for volunteers" when new members are needed. Interested providers will need to submit an application and complete ASTRO’s Conflict of Interest Disclosure Form.
All providers who are part of the radiation oncology treatment team, including radiation oncologists, medical physicists, dosimetrists, nurses, technologists and practice administrators, are eligible to enter data into RO-ILS if their practice has signed a contract with Clarity PSO to participate.
Interested providers may download the Participation Guide from the ASTRO website. The Participation Guide outlines step-by-step instructions for participation.
The Participation Guide is a document outlining the steps for RO-ILS participation. A list of the data elements collected in RO-ILS, a sample contract and additional educational material pertinent to RO-ILS are also contained in the Participation Guide. You can download the Participation Guide from the ASTRO website.
If my institution already reports to another PSO, can we still participate in RO-ILS?
Yes. A practice can participate in more than one PSO.
Are there different requirements for contracting with Clarity PSO depending on practice setting?
No. Clarity PSO’s requirements for contracting are the same regardless of practice setting.
The entity that signs the contract with Clarity PSO will depend on your practice. Clarity PSO will work with you to determine the plan that best meets the needs of your department and institution.
Currently, there is no cost to participate.
The contracting process will be different for each practice. Please contact Clarity PSO if your practice has specific questions about the contract. Please contact ASTRO if you need guidance on how to begin discussions and/or gain support within your practice for RO-ILS participation. It is also recommended that you consult qualified legal counsel.
Using the Consensus recommendations for incident learning database structures in radiation oncology (Ford EC, Fong de los Santos L, Pawlicki T, Sutlief S, Dunscombe P. Med Phys. 2012; 39: 7272-7290) as a baseline, Clarity PSO and the ASTRO-AAPM joint steering committee identified a template for the collection of commonly reported radiation oncology events. Clarity PSO built RO-ILS using this template. A list of the data elements is available in the Participation Guide.
Currently, there is not a mechanism to map RO-ILS with already existing incident learning systems.
Each contract receives three user names and passwords. One user name and password serves as a general login and grants access to the "Submit Event" page, where the user performs initial, front-line reporting. The additional two logins serve as full-access logins and grant access to the "My Review" page, as well as the "Submit Event" page. The "My Review" page is where users enter follow-up analysis and eventually report the data to the PSO. It is up to the individual institution to decide who is responsible for submitting events and who is responsible for completing the follow-up analysis. The institution should share logins among users, as needed.
The only patient specific information entered into RO-ILS is a patient’s age (as a range) and gender. Date and time of the event is also collected which may potentially correspond with a date of treatment. These elements were suggested by AHRQ in its common formats in order to facilitate standardized data collection and aggregation across all PSOs.
RO-ILS does not place specifications or limits on the type of data reported to Clarity PSO. We encourage participating institutions to submit events to the PSO to strengthen aggregate and facility-specific reports and enable shared learning nationwide. This could include, for example, information about near-misses or patient safety incidents.
You can run a report from the RO-ILS portal to view your safety events transmitted to Clarity PSO.
No. When data are extracted from the system, it will automatically default to the most current information, and the additional information entered will be reported.
You have the ability to query your own data within RO-ILS. Should you want to do further research or analysis using additional data from the national database, you will need to submit a request to Clarity PSO to access non- identifiable, aggregate data.
RO-ILS is a Web-based portal hosted within Clarity’s network. From an implementation standpoint, the portal is either used over an SSL connection (Port 443) or a VPN connection (Port 80). No servers are required for the users. The hosting 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 2008 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 Group Inc., and Clarity PSO engage in HIPAA 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:
The RO-ILS portal is best viewed in Internet Explorer 8, Internet Explorer 9, Internet Explorer 10, and Internet Explorer 11. Clarity PSO is in the process of testing the compatibility and functionality of other browsers.
Yes. Users can view the RO-ILS portal over mobile or tablet devices running Windows, iOS and Android operating systems via a browser. There are no applications installed on mobile devices. Optimal viewing and performance is in Internet Explorer.
Only providers covered under your contract are allowed to see the data you entered into RO-ILS. Providers from other institutions will not see your data and vice versa. Only Clarity PSO staff have access to identifiable data after submission to Clarity PSO.
All data shared with contracted consultants (e.g., RO-HAC) are stripped of identifying elements and aggregated, as required by the PSQIA and HIPAA; however, there may be instances where RO-HAC may request or be required to view identifiable data in order to advance a particular clinical or patient safety activity. Clarity PSO and the individual RO-HAC members sign agreements that comply with PSQIA and HIPAA to protect the confidentiality of identifiable data that are shared.
No. Information shared with other providers participating in RO-ILS and/or ASTRO is "nonidentified," as that term is defined in the PSQIA, meaning that it is stripped of identifying elements, including information relating to health care providers.
A provider can disclose his or her information, under certain circumstances, in an identified manner by signing an Authorized Disclosure Form. This permits an outside party to view the identifiable information. For example, a provider may want additional support, expert recommendations or further analysis on a serious event. Clarity PSO will provide an Authorized Disclosure Form upon request.
All data are returned to the original owner and deleted from Clarity’s servers; however, it is not possible to retract information submitted to Clarity PSO once included in aggregate form. The total aggregate compendium of unidentifiable data remains housed in Clarity PSO's database.
Clarity regularly monitors and reports on invalid log in attempts, valid users logging into system, dormant user account activity and user access activity. Clarity also 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.
RO-ILS is the only medical specialty society-sponsored incident learning system for radiation oncology. By contracting with Clarity PSO, the providers and all of the data entered in RO-ILS are protected as outlined in the PSQIA. RO-ILS ensures that information is synthesized to provide excellent education for practitioners. Other benefits include:
Yes. RO-ILS is qualified for physicians and physicists by the American Board of Radiology (ABR) in meeting the criteria for practice quality improvement (PQI), toward the purpose of fulfilling requirements in the ABR Maintenance of Certification Program. More information can be found on the ASTRO website.
Can participation in RO-ILS be used for Medicare’s Merit-Based Incentive Payment System (MIPS)?
Yes. Beginning of 2017, MIPS is a component of Medicare’s Quality Payment Program and will positively or negatively adjust Medicare Part B reimbursement based on eligible clinician’s 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 can help satisfy this category. In the 2017 transition year of MIPS, one Improvement Activity is sufficient to avoid a negative payment adjustment utilization of RO-ILS will fulfil this option. For more information on MIPS, please visit https://www.astro.org/macra/
What kind of documentation do I need for MIPS?
For the 2017 transition year of MIPS, eligible clinicians will need to attest yes or no to completing Improvement Activities. In the event of an audit, ASTRO recommends maintaining proper documentation of RO-ILS involvement. Upon request, Clarity PSO will send a letter stating that your practice or facility is actively participating in RO-ILS. Additionally, be sure to keep a copy of your PSES policy as another form of proof. Lastly, consider completing a Plan-Do-Study-Act process, a component of MOC, to document RO-ILS participation for MIPS.
RO-ILS participants receive institution-specific summary reports (e.g., data relating to treatment technique, type of equipment, dosimetric severity scale, etc.) for their institution, including aggregate data on events entered throughout the country, developed by Clarity PSO and RO-HAC. In addition, “Tips of the Month” are sent to users to provide programmatic updates, suggestions for best practices, and general incident learning and safety culture tools.
No. Currently, there are more than 75 PSOs qualified with AHRQ, including many that work with national organizations and other specialty societies.