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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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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

Background: 2 international reporting systems

Detailed look at ROSIS

Detailed look at SAFRON


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


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


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


ROSIS

www.rosis.info ; [email protected]


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


Use of ROSIS


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


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)


Department information in ROSIS


Incident information in ROSIS


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?


Incident information in ROSIS

Detected how?


Incident information in ROSIS

  • Incident / near-incident

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

  • Outcome

    • 86% of incidents affected 1 to 3 fractions


Incident information in ROSIS

Type of information recorded


Incident information in ROSIS


Incident information in ROSIS


Incident information in ROSIS


Incident information in ROSIS

Process steps

4 “levels”


Incident information in ROSIS


Dynamic questions on process


Dynamic questions on process


SAFRON

[email protected]


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;


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


SAFRON


SAFRON information flow

Input

Output

Incident

reports

Local

info

Other

systems

Shared

info

SAFRON

Other

info

Targeted

guidance


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


SAFRON


SAFRON


SAFRON


SAFRON


SAFRON


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


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


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


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


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


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


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


Live demo of ROSIS and SAFRON …

  • http://www.rosis.info/

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


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