Introduction
This article presents the list of risk analysis templates currently available for myQA PROactive. Templates are based on data from the cited literature, which have been simplified, generalized and if necessary integrated based on the experience of the authors.
Unless authors are explicitly mentioned, the templates have been prepared by IBA Dosimetry.
If clinical partners of IBA are present among the authors, the local practice at their institutions has been considered as well.
Important Note:
Risk analysis templates may serve as a starting point for users who would like to adapt them to their own clinical processes without performing a risk analysis from scratch.
All data in templates must be carefully reviewed, adapted and integrated in order to generate a valid risk analysis of a clinical process.
A template shall not be used as a ready-made risk analysis for a clinical process.
Template for EBRT
Content: example of risk analysis for an External Beam Radiation Therapy process. It includes IGRT (Image Guided Radiation Therapy).
Developed in the framework of the project “ProteQt: Adaptives Risiko Management für die Radio-Onkologie", co-funded by the state of Bavaria
Download:
EBRT - template for myQA PROactive
Authors:
- D. Kornek, C. Bert (Universitätsklinikum Erlangen).
- B. Gungor, D. Menichelli, J. Leske (IBA Dosimetry GmbH).
References:
- Huq, M. et al., “The Report of Task Group 100 of the AAPM: Application of Risk Analysis Methods to Radiation Therapy Quality Management.” Med. Phys. 43, (2016): 4209–62. https://doi.org/10.1118/1.4947547.
- Ford, Eric C., et al. “Quality Control Quantification (QCQ): A Tool to Measure the Value of Quality Control Checks in Radiation Oncology.” Int. J. Rad. Onc. Biol. Phys. 84, 2012: e263–69. https://doi.org/10.1016/j.ijrobp.2012.04.036.
- WHO. “Radiotherapy Risk Profile- Technical Manual,” 2008. http://www.who.int/patientsafety/activities/technical/radiotherapy_risk_profile.pdf.
Template for MR Linac
Content: example of risk analysis for treatment with a MR LINAC, including ART (Adaptive Radiation Therapy) workflow component. It has been developed based on cited literature.
Download:
MR Linac - template for myQA PROactive
References:
- Klüter, S. et al. “A Practical Implementation of Risk Management for the Clinical Introduction of Online Adaptive Magnetic Resonance-Guided Radiotherapy.” Physics and Imaging in Radiation Oncology 17 (January 1, 2021): 53–57. https://doi.org/10.1016/j.phro.2020.12.005.
Template for SGRT Breast DIBH
Content: example of risk analysis for Surface Guidance Radiation Therapy (SGRT) for breast treatment with Deep Inspiration Breath Hold (DIBH).
Download:
SGRT Breast DIBH - template for PROactive
Authors:
- Serenella Russo, AUSL Toscana Centro, S. Maria Annunziata Hospital (Florence)
- David Menichelli (IBA Dosimetry GmbH)
References:
- • Al-Hallaq, H. A., et al., “AAPM Task Group Report 302: Surface-Guided Radiotherapy.” Med. Phys. 49, 2022: e82–112. https://doi.org/10.1002/mp.15532.
- • M. Bright et al, “Failure mode and effect analysis for surface-guided DIBH breast radiotherapy”, J. Appl. Clin. Med. Phys., 2022.
- • S. Russo, M. Esposito, A. Bruschi, A. Ghirelli, P. Alpi , S. Scoccianti, “FMEA risk analysis of surface-guided DIBH breast radiotherapy by using a commercial software tool,” ESTRO 2023, 12-16 May 2023 Vienna, accepted as digital poster.
Template for Tomotherapy
Content: example of risk analysis for External Beam Radiation Therapy (EBRT) with Tomotherapy equipment. It has been developed by adapting the EBRT template with Tomotherapy-specific data from the cited literature.
Download:
Tomotherapy - template for myQA PROactive
References:
- Broggi, S. et al. “Application of Failure Mode and Effects Analysis (FMEA) to Pretreatment Phases in Tomotherapy.” J. Appl. Clin. Med. Phys. 14, 2013: 265–77. https://doi.org/10.1120/jacmp.v14i5.4329.
Template for SBRT
Content: example of risk analysis for stereotactic External Beam Radiation Therapy (EBRT), including Stereotactic Body Radiation Therapy (SBR) and Stereotactic Radio Surgery (SRS) with linear accelerators. It has been developed by adapting the EBRT template with stereotaxy specific data from the cited literature.
Download:
SBRT - template for myQA PROactive
References:
- Younge, K. C., et al. “Practical Implementation of Failure Mode and Effects Analysis for Safety and Efficiency in Stereotactic Radiosurgery.” Int. J. Rad. Oncol. Biol Phys. 91, 2015: 1003–8. https://doi.org/10.1016/j.ijrobp.2014.12.033.
Template for Adaptive Radiation Therapy (ART) with Ethos (Varian)
Content: example of risk analysis for adaptive radiation therapy (ART) with Ethos equipment. It has been developed by adapting the EBRT template with Ethos-specific data from the cited literature.
Download:
Adaptive Radiation Therapy (ART) with Ethos (Varian) - template for myQA PROactive
References:
- Wegener, S. et al., “Prospective Risk Analysis of the Online-Adaptive Artificial Intelligence-Driven Workflow Using the Ethos Treatment System.” Z. Med. Phy., 2022. https://doi.org/10.1016/j.zemedi.2022.11.004.
Template for CyberSecurity
Content: example of risk analysis for hospital cybersecurity, taking into account the cyber security relevant assets which could be attacked, and the safety measures suitable to protect them.\
Download:
CyberSecurity - template for myQA PROactive
References:
- Younge, K. C., et al. “Practical Implementation of Failure Mode and Effects Analysis for Safety and Efficiency in Stereotactic Radiosurgery.” Int. J. Rad. Oncol. Biol Phys. 91, 2015: 1003–8. https://doi.org/10.1016/j.ijrobp.2014.12.033.
- ISO/IEC 27002- Information Security, Cybersecurity and Privacy Protection — Information Security Controls, 2022.
- European Union Agency for Cybersecurity. ENISA Threat Landscape 2022, 2022.
- Joyce, Christine, Faustin Laurentiu Roman, Brett Miller, John Jeffries, and Robert C. Miller. “Emerging Cybersecurity Threats in Radiation Oncology.” Advances in Radiation Oncology 6, no. 6 (September 20, 2021): 100796. https://doi.org/10.1016/j.adro.2021.100796.
- Office of information security, and Health sector cybersecurity coordination center. “2022 Healthcare Cybersecurity Year in Review, and a 2023 Look-Ahead.” February 9, 2023.
- Verizon. “2022 Data Breach Investigations Report,” 2022.
- IBM Security. “Cost of a Data Breach Report 2022,” 2022. https://www.ibm.com/downloads/cas/3R8N1DZJ.
- Sophos. “The State of Ransomware 2022,” 2022. https://news.sophos.com/en-us/2022/04/27/the-state-of-ransomware-2022/.
- CISCO. “Cybersecurity Threat Trends: Phishing, Crypto Top the List,” 2021. https://umbrella.cisco.com/info/2021-cyber-security-threat-trends-phishing-crypto-top-the-list.