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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 . Contents.

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international reporting systems

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

slide2

Contents

Background: 2 international reporting systems

Detailed look at ROSIS

Detailed look at SAFRON

slide3

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
slide4

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
slide5

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
slide6

ROSIS

www.rosis.info ; rosis@rosis.info

slide7

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
slide9

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
slide10

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)
slide13

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?

slide15

Incident information in ROSIS

  • Incident / near-incident
    • 576 (51%) reports: some incorrect treatment delivered
  • Outcome
    • 86% of incidents affected 1 to 3 fractions
slide16

Incident information in ROSIS

Type of information recorded

slide20

Incident information in ROSIS

Process steps

4 “levels”

slide24

SAFRON

SAFRON.Contact-Point@iaea.org

slide25

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;
slide26

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
slide28

SAFRON information flow

Input

Output

Incident

reports

Local

info

Other

systems

Shared

info

SAFRON

Other

info

Targeted

guidance

slide29

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
slide36

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

slide37

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

slide38

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

slide39

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

slide40

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

slide41

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

slide42

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
slide43

Live demo of ROSIS and SAFRON …

  • http://www.rosis.info/
  • https://rpop.iaea.org/SAFRON/Default.aspx
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