The Center for Assessment of Radiological Sciences (CARS) with certification from the Agency for Healthcare Research and Quality (AHRQ) as a patient safety organization (PSO) operates the Radiotherapy Incident Reporting and Analysis system (RIRAS) for reporting and learning from radiotherapy adverse events, good catches and unsafe conditions.

The RIRAS is an important facet of the continuing effort by the radiation oncology community to maintain and improve radiotherapy safety. A key attribute of RIRAS is the strong confidentiality protections to the radiation oncology facilities and providers who report adverse events and incidents to CARS.

The submitted data are immediately reviewed, further investigated, and analyzed by qualified radiation oncology team members at CARS-PSO who have domain expertise and industrial engineering and human factors experience. A team of radiation oncologists and medical physicists who have expertise in radiation oncology quality and safety issues provide an oversight of all CARS activities.

RIRAS is fully compliant with the patient safety act and has following attributes:

•  Development and dissemination of information with respect to improving patient safety: The RIRAS has utilities that provide a corrective action plan for each adverse event reported by the radiotherapy provider. The feedback to the provider includes recommendations for mitigating future errors, protocols for safe operations, and information regarding best practices. The threshold for adverse events that require a corrective action plan is developed by the CARS qualified experts in consultation with the safety experts.

•  Using patient safety work product to encourage a culture of safety and to provide feedback and assistance to effectively minimize patient risk: The de-identified aggregated data collected by the RIRAS is used to develop safe standard operating procedures for each radiotherapy treatment modality and technique. An oversight committee of radiation oncology domain experts provides guidance on this particular activity.

•  Maintenance of procedures to preserve confidentiality with respect to patient safety work product: The adverse event reported data do not contain any patient health information (PHI). However, the data reported by radiotherapy providers includes facility data, which only is used to investigate the reported event. The aggregated data reports generated by CARS do not include facility information. The patient safety product meets all security requirements described in §3.106 of 42 CFR part 3.

•  Provision of appropriate security measures with respect to patient safety work product: The RIRAS uses a secure and redundant database infrastructure. All data communication is encrypted according to established safety standards.

•  Utilization of qualified staff: The CARS staff has the required radiation oncology domain expertise to analyze reported adverse events. Staff includes radiation oncologists, radiation oncology therapists with dosimetry experience, medical physicists, and industrial engineers with radiation therapy experience. Staffing proceeds from part-time to multiple full-time positions as the work load escalates. Each staff member has gone through HIPAA compliance (45 CFR 164.506) and patient safety training through established University of Wisconsin (UW) training programs.

•  Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system:  CARS works closely with an oversight committee of radiation oncology domain experts to establish criteria for the evaluation of patient safety. Initial guidance for safety evaluation came from the AAPM report on prevention of errors.

•  Improvement to patient safety and the quality of health care delivery of patients treated with radiotherapy: The electronic infrastructure of the RIRAS is used to collect and aggregate adverse event and incident data from radiotherapy providers. The radiation oncology domain expert staff at CARS analyzes each reported event and determines its cause and severity. The de-identified aggregated data are analyzed to evaluate population-based trends, which in turn is used to improve the safety and quality of radiotherapy.