Purpose: To develop a systematic risk management method that uses failure modes and effects analysis (FMEA) to design mitigation efforts to control pandemic infection spread, while ensuring safe delivery of quality radiotherapy.
Methods: We define Infection containment failure mode (ICFM) to be any scenario where transmission of the infection occurs within the clinic. A two-stage approach has been developed for application of FMEA to radiotherapy workflow during a pandemic. In stage 1, the FMEA is focused on ICFMs, where risk priorities are evaluated based on available data and modeling of the pandemic infection. An infection risk priority number (IRPN) has been defined as a function of time, distance and protective gear. Subsequently, infection containment mitigation plans are integrated into the radiotherapy workflow. In stage 2, a traditional FMEA will be conducted on the adjusted workflow with a focus on radiotherapy failure mode (RFM) prevention. Furthermore, additional RFM mitigation plans will be introduced in the workflow, thereby iteratively returning to stage 1 for reevaluation of additional ICFMs.
Results: The COVID-19 pandemic has been used to illustrate the two-stage systematic approach to risk management developed in this work. Selected parts of the radiotherapy process have been used to demonstrate examples of ICFM identification and failure mode mitigation. For a pre-pandemic CT-simulation workflow, 14 ICFMs were identified. For each ICFM, the IRPN was calculated based on average time, distance, and degree of protective gear with values ranging from 3 - 100. Various infection control measures were subsequently added to the CT-simulation workflow thereby reducing the IRPN scores. The modified workflow was then evaluated for RFMs and subsequently additional mitigation plans were introduced.
Conclusion: The framework developed in this work offers a tool for radiotherapy clinics to systematically assess risks, adjust workflows, and allocate resources in response to the challenges during a pandemic.
Quality Control, Risk, Radiation Therapy
IM/TH- Formal Quality Management Tools: Failure modes and effects analysis