International Reporting Systems

1. Patient Safety in Radiation Oncology, Melbourne 4-5 October 2012 International Reporting Systems Ola Holmberg, PhD Head, Radiation Protection of Patients Unit Radiation Safety and Monitoring Section NSRW International Atomic Energy Agency - IAEA Vienna, Austria

2. Contents Background: 2 international reporting systems Detailed look at ROSIS Detailed look at SAFRON

3. Background: 2 international reporting systems • 1. ROSIS (Radiation oncology safety information system) • International web-based voluntary incident reporting system in radiotherapy • Developed by a small group of health professionals in Europe • Supported by ESTRO in the initial development stages

4. Background: 2 international reporting systems • 2. SAFRON (Safety in radiation oncology) • International web-based voluntary incident reporting system in radiotherapy • Under development by the IAEA • To be released (following pilot-study) later in 2012

5. Background: 2 international reporting systems • Why 2 international reporting systems? • SAFRON is funded through a regular budget in a major international organization – ROSIS has so far been mainly based on voluntary work (and some funding through e.g. safety courses) • ROSIS might have the opportunity to work more closely with commercial companies / manufacturers – SAFRON has to be much more restrictive in this area due to its’ setting in the United Nations • The main point is that the two systems are in collaboration, sharing information, and working towards the same goal of patient safety

6. ROSIS www.rosis.info ; rosis@rosis.info

7. Aims and objectives of ROSIS Improve safety: • By enabling RT departments to share and view reports on incidents • By collecting and analysing information on the occurrence, detection, severity and correction of RT incidents • By disseminating the results and promoting awareness of incidents and a safety culture in RT

8. Use of ROSIS

9. Department statistics of ROSIS • 150 Departments registered worldwide • Europe • 91 departments representing 16 countries • Africa, Asia, Australia, North America/Canada, South/Central America • Up to 24 departments per region

10. Department statistics of ROSIS • Department demographics (2011) • 426 Linear Accelerators (mean 3 per Department) • 55 Cobalt Machines (mean 0.4 per Department) • 145 Brachytherapy machines (mean 1 per Department) • Patient population of approximately 210,000 new patients per year (mean 1400 per Department)

11. Department information in ROSIS

12. Incident information in ROSIS

13. Incident information in ROSIS • 1074 reports • External Beam RT • 97.7% (1049) • Brachytherapy • 1.9% (20) • Other modalities • 0.5% (5) (mainly non-process) Who detected?

14. Incident information in ROSIS Detected how?

15. Incident information in ROSIS • Incident / near-incident • 576 (51%) reports: some incorrect treatment delivered • Outcome • 86% of incidents affected 1 to 3 fractions

16. Incident information in ROSIS Type of information recorded

17. Incident information in ROSIS

18. Incident information in ROSIS

19. Incident information in ROSIS

20. Incident information in ROSIS Process steps 4 “levels”

21. Incident information in ROSIS

22. Dynamic questions on process

23. Dynamic questions on process

24. SAFRON SAFRON.Contact-Point@iaea.org

25. SAFRON • Safety in Radiation Oncology (SAFRON) • Expected properties of the system: • Enables learning from incidents and near incidents; • Is dynamic and applicable in a wide range of settings; • Can take account of new technology or processes; • Supports education & training; • Enables easy sharing of information and feedback; • Integrates retrospective reporting and prospective risk analysis; • Integrates with existing systems, complementing national and mandatory systems;

26. SAFRON • Safety in Radiation Oncology (SAFRON) • Properties of the system in pilot-phase: • SAFRON collaborates with other reporting systems, and currently contains incident information gathered by the IAEA and ROSIS • SAFRON has over 1100 incidents and near misses in its database • SAFRON is non-punitive, anonymous, and voluntary • SAFRON is a comprehensive source of information for radiation safety related events • SAFRON includes information on a wide variety of published scientific journals and incident reports

27. SAFRON

28. SAFRON information flow Input Output Incident reports Local info Other systems Shared info SAFRON Other info Targeted guidance

29. SAFRON • Safety in Radiation Oncology (SAFRON) • SAFRON will be put on http://rpop.iaea.org • Dedicated website on radiation protection of patients reaching >1 million hits per month, targeting health professionals and other stakeholders

30. SAFRON

31. SAFRON

32. SAFRON

33. SAFRON

34. SAFRON

36. SAFRON • New feature to be introduced in SAFRON: Safety Barriers • Which safety barriers did NOT find the incident? • Which safety barrier found the incident? • If this safety barrier had not found the incident, which of your subsequent barriers might have found it? Safety Barrier 1 Safety Barrier 2 Safety Barrier 3 Safety Barrier 4 Patient Incident

37. SAFRON • New feature to be introduced in SAFRON: Safety Barriers • Overall available safety barriers to be queried in Registration form (check-boxes) • Relevant safety barriers in context of incident to be queried in Incident Report form • Might influence reporter to think about defence-in-depth, effectiveness of safety barriers, and what safety barriers are in place for safety critical steps Safety Barrier 1 Safety Barrier 2 Safety Barrier 3 Safety Barrier 4 Patient Incident

38. SAFRON • New feature to be introduced in SAFRON: Safety Barriers • Example: Wrong SSD used for manual inverse square calculation of MU for manually calculated patient plan Diode measurement Independent calculation check Weekly chart check “Time-out” Wrong SSD in calculations Patient

39. SAFRON • New feature to be introduced in SAFRON: Safety Barriers • Example: Wrong SSD used for manual inverse square calculation of MU for manually calculated patient plan • Which safety barriers did NOT find the incident? Diode measurement Independent calculation check Weekly chart check “Time-out” Wrong SSD in calculations Patient

40. SAFRON • New feature to be introduced in SAFRON: Safety Barriers • Example: Wrong SSD used for manual inverse square calculation of MU for manually calculated patient plan • Which safety barrier found the incident? Diode measurement Independent calculation check Weekly chart check “Time-out” Wrong SSD in calculations Patient

41. SAFRON • New feature to be introduced in SAFRON: Safety Barriers • Example: Wrong SSD used for manual inverse square calculation of MU for manually calculated patient plan • If this safety barrier had not found the incident, which of your subsequent barriers might have found it? Diode measurement Independent calculation check Weekly chart check “Time-out” Wrong SSD in calculations Patient

42. Strengths of SAFRON • Ease of use • Funding available • Manpower available • IAEA has global reach • IAEA has well-established record in safety activities • IAEA is seen as independent • IAEA is well-placed to target guidance to all relevant stakeholders • Opportunity to place system on much visited web-site (rpop.iaea.org) • System developed in parallel with “radiological system” • Opportunity to place maintenance with “professionals” • Good connection with other initiatives – might serve as “meta-system” • Can to some extent serve as both global and local system • Available for general use: Probably before December 2012

43. Live demo of ROSIS and SAFRON … • http://www.rosis.info/ • https://rpop.iaea.org/SAFRON/Default.aspx