1. IAEA International Atomic Energy Agency 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 Patient Safety in Radiation Oncology, Melbourne 4-5 October 2012

2. IAEA 1. Background: 2 international reporting systems 2. Detailed look at ROSIS 3. Detailed look at SAFRON Contents

3. IAEA 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 Background: 2 international reporting systems

4. IAEA 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 Background: 2 international reporting systems

5. IAEA 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 Background: 2 international reporting systems

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

7. IAEA Aims and objectives of ROSIS  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. IAEA Use of ROSIS 8

9. IAEA 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. IAEA 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) Department statistics of ROSIS

11. IAEA Department information in ROSIS

12. IAEA Incident information in ROSIS

13. IAEA 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. IAEA Incident information in ROSIS Detected how?

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

16. IAEA Incident information in ROSIS Type of information recorded

17. IAEA Incident information in ROSIS

18. IAEA Incident information in ROSIS

19. IAEA Incident information in ROSIS

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

21. IAEA Incident information in ROSIS

22. IAEA Dynamic questions on process

23. IAEA Dynamic questions on process

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

25. IAEA 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; SAFRON

26. IAEA 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 SAFRON

27. IAEA SAFRON

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

29. IAEA 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 SAFRON

30. IAEA SAFRON

31. IAEA SAFRON

32. IAEA SAFRON

33. IAEA SAFRON

34. IAEA SAFRON

35. IAEA

36. 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? SAFRON Safety Barrier 1Safety Barrier 2Safety Barrier 3 Patient Incident Safety Barrier 4

37. IAEA 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 SAFRON Safety Barrier 1Safety Barrier 2Safety Barrier 3 Patient Incident Safety Barrier 4

38. IAEA 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 SAFRON Independent calculation check “Time-out” Diode measurement Patient Wrong SSD in calculations Weekly chart check

39. IAEA 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? SAFRON Independent calculation check “Time-out” Diode measurement Patient Wrong SSD in calculations Weekly chart check

40. IAEA 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? SAFRON Independent calculation check “Time-out” Diode measurement Patient Wrong SSD in calculations Weekly chart check

41. IAEA 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? SAFRON Independent calculation check “Time-out” Diode measurement Patient Wrong SSD in calculations Weekly chart check

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

44. IAEA