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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


International reporting systems

Contents

Background: 2 international reporting systems

Detailed look at ROSIS

Detailed look at SAFRON


International reporting systems

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


International reporting systems

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


International reporting systems

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


International reporting systems

ROSIS

www.rosis.info ; [email protected]


International reporting systems

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


International reporting systems

Use of ROSIS


International reporting systems

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


International reporting systems

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)


International reporting systems

Department information in ROSIS


International reporting systems

Incident information in ROSIS


International reporting systems

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?


International reporting systems

Incident information in ROSIS

Detected how?


International reporting systems

Incident information in ROSIS

  • Incident / near-incident

    • 576 (51%) reports: some incorrect treatment delivered

  • Outcome

    • 86% of incidents affected 1 to 3 fractions


International reporting systems

Incident information in ROSIS

Type of information recorded


International reporting systems

Incident information in ROSIS


International reporting systems

Incident information in ROSIS


International reporting systems

Incident information in ROSIS


International reporting systems

Incident information in ROSIS

Process steps

4 “levels”


International reporting systems

Incident information in ROSIS


International reporting systems

Dynamic questions on process


International reporting systems

Dynamic questions on process


International reporting systems

SAFRON

[email protected]


International reporting systems

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;


International reporting systems

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


International reporting systems

SAFRON


International reporting systems

SAFRON information flow

Input

Output

Incident

reports

Local

info

Other

systems

Shared

info

SAFRON

Other

info

Targeted

guidance


International reporting systems

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


International reporting systems

SAFRON


International reporting systems

SAFRON


International reporting systems

SAFRON


International reporting systems

SAFRON


International reporting systems

SAFRON


International reporting systems

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


International reporting systems

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


International reporting systems

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


International reporting systems

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


International reporting systems

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


International reporting systems

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


International reporting systems

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


International reporting systems

Live demo of ROSIS and SAFRON …

  • http://www.rosis.info/

  • https://rpop.iaea.org/SAFRON/Default.aspx


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