What type of events does RO-ILS collect?
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.
What are the RO-ILS data elements?
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.”
Is protected health information (PHI) required for RO-ILS?
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.
Can RO-ILS accept data through an automatic electronic data transfer?
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.
Who can access the data once it is entered into RO-ILS?
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.
Will my identifiable information be shared outside of RO-ILS?
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.
Can I query the database?
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 firstname.lastname@example.org.