Learning from ErrorsLearning from Errors– the National Picture

British Institute of RadiologyRadiotherapy Errors and Near Misses

Centre for Radiation, Chemical and Environmental Hazards

Úna FindlayMedical Exposure Department

28th September 2012

OverviewOverview

Background to National Reporting & Learning Systems

1. Reporting Mechanism

• Describe Data Flow

2. Analysis & Results

• HPA & Patient Safety in Radiotherapy Steering Group

3. Dissemination of Learning

• Methods

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• Methods

Future Work

Reporting in the Next Decade

Why have a national reporting & Why have a national reporting & learning system?learning system?

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Improve Patient Safety

Scally, G and Donaldson, LJ. BMJ 1998; 317: 61–65.

Types of National Reporting SystemsTypes of National Reporting Systems- Statutory & Voluntary

Statutory

Reporting of defined incidents is V l t

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Reporting of defined incidents is required by law, not to report would be a criminal offence.

e.g reporting to regulatory bodies

(may be a threshold above which incidents should be reported)

Voluntary

Reporting is encouraged, no penalties for not reporting

e.g reporting to professional bodies / independent agency

(include near misses)

ACCIRAD ACCIRAD EU-funded project looking at national reporting systems

Objectives:

1. Study the implementation UK Representatives:Steve Ebdon-Jackson

of the Council Directive 97/43/EURATOM (Medical Exposure Directive, MED) requirements aimed at the reduction of the probability and the magnitude of accidents in radiotherapy

Andrew Nisbet (Panel of Scientific Experts)Úna Findlay

UK Radiotherapy Departments:Hull

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accidents in radiotherapy

2. Develop guidelines on a risk analysis of accidental and unintended exposures in external beam radiotherapy.

UCLH

Further information available at: www.accirad.eu

UK requirements for a national UK requirements for a national reporting & learning systemreporting & learning system

1. Operate independently from enforcement authority

2. Be able to contact centre if clarification is required

3. Maintain patient confidentiality

4. Have endorsement of professional bodies

5. Disseminate lessons learnt

6. Improve feedback

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7. Recommendations for changes in practice; in collaboration with professional bodies.

8. Provide accurate (if outline), details of a major radiation incident to other radiotherapy centres as soon as possible.

Timeline for UK radiotherapy Timeline for UK radiotherapy reporting & learning systemreporting & learning system

2003 2006 2008 2010 2010 2010

CMO RCR & et alNRLS HPA & PSRT

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2003 2006 2008 2010 2010 2010

Data flow in UK RT reporting & Data flow in UK RT reporting & learning systemlearning system

RTE Report

RT D t t‘TSRT9’ Trigger Code

& Class and Coding

Feedback

RT community

Risk Management Team

Shared Learning

RT Department

Electronic transfer

& Class and Coding

From Dec 2009- Aug 2012 5,053 reports submitted from 41 centres N ti l

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Feedback

HPA group analysis

HPA website

from 41 centres National Reporting and

Learning System

Electronic transfer of anonymous data

PSRT Review

Results of AnalysisResults of Analysis2 Year Reports

Second 2 Yearly Second 2 Yearly Analysisof RTE Data published in of RTE Data published in

July 2012July 2012

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www.hpa.org.uk/radiotherapy

Classification of reports Classification of reports Dec 09 – Nov 11(n=3316)

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Breakdown of Level 1 RTEBreakdown of Level 1 RTEDec 09 – Nov 11

(n= 38/3316)

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Breakdown of Level 1 process code13Breakdown of Level 1 process code13Dec 09 – Nov 11 (n= 24/38)

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Comparison of Level 1 NRLS and Comparison of Level 1 NRLS and Inspectorate Data Inspectorate Data Dec 09 – Nov 11 (n= 38 V 69)

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Most frequently occurring Process Most frequently occurring Process SubSub--codes reported by Classificationcodes reported by ClassificationDec 09 – Nov 11 (n= 1353/3316)

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Comparison of classification levels between Comparison of classification levels between 2010 & 2012 Reports2010 & 2012 Reports2010 Aug 07 – Nov 09 (n = 1012)2012 Dec 09 – Nov 11 (n =3316)

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Results of AnalysisResults of AnalysisQuarterly Newsletter & Analysis

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www.hpa.org.uk/radiotherapy

Classification of reportsClassification of reportsAug 11 to Jul 12 (n=2083)

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Breakdown of Level 3 RTE reports Breakdown of Level 3 RTE reports by process codeby process codeAug 11 – Jul 12 (n=587/601)

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Breakdown of Level 3 process code13Breakdown of Level 3 process code13Aug 11 – Jul 12 (n= 269/333)

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Breakdown of Level 3 process code11Breakdown of Level 3 process code11Aug 11 – Jul 12(n= 57/59)

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Breakdown of RTEs Main Themes by Breakdown of RTEs Main Themes by Classification Level Classification Level Aug 11 to Jul 12 (n=785/2096)

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Improve patient safety in radiotherapy in theUK by building on the recommendations of‘Towards Safer Radiotherapy’ supporting their

Patient Safety in Radiotherapy Patient Safety in Radiotherapy Steering GroupSteering Group

py pp gimplementation and taking them forward.

Provide a review of and recommendations onresults of analysis.

Leslie Frew (IPEM) ( )

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Tony Murphy (Patient Representative)Tom Roques (RCR)Maria Murray (SCoR)Martin Duxbury (Clinical Radiographer SCoR Representative) Úna Findlay (HPA)

Group Membership:

Dissemination of LearningDissemination of Learning

• 2 Yearly Reports

• Quarterly Newsletter ‘ Safer Radiotherapy’y py

• Quarterly Full Analysis

• (HPA Radiotherapy Webpage)

• Targeted email alerts: Radiotherapy Centres, Professional Bodies, Inspectorates, NRLS, Manufacturers, MHRA, NRIG SRPB

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NRIG, SRPB

• Presentations: SCoR, ESTRO, IPEM, BIR etc

• International Collaboration: ROSIS, IAEA, ASN, Treat Safely, EU - ACCIRAD Project

• HPA Clinical Site Visits

UK requirements for a national UK requirements for a national reporting & learning systemreporting & learning system

1. Operate independently from enforcement authority

2. Confidential but able to contact centre if clarification is required

3. Maintain patient confidentiality

4. Have endorsement of professional bodies

5. Disseminate lessons learnt

6. Improve feedback

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p

7. Recommendations for changes in practice in collaboration with professional bodies

8. Provide accurate (if outline) details of a major radiation incident to other radiotherapy centres as soon as possible

• Continue to improve system , analysis & feedback

FutureFutureVoluntary Reporting

• Streamline reporting mechanism for Scotland & Northern Ireland

• Develop analysis to include a Causative Factor & Detection Methods taxonomy

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• Support international reporting

• ? Amended patient safety in medical exposure legislation……

Reporting in the Next Decadep g

British Institute of RadiologyRadiotherapy Errors and Near Misses

Centre for Radiation, Chemical and Environmental Hazards

Úna FindlayMedical Exposure Department

28th September 2012

Basis for ReportingBasis for Reporting

1. Euratom Basic Safety Standards Directive

2. EMGTI – guidance for regulators

3. HERCA - EMGTI

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• EU council directive 97/43/EURATOM of June 97 ‘on health protection of individuals against the dangers of i i i di i i l i di l ’

1.1. Euratom Basic Safety Standards Euratom Basic Safety Standards DirectiveDirective

ionising radiation in relation to medical exposure’,

• Revised BSS Directive Chapter VII (Articles 54 – 63)

‘Protection of patients and other individuals subjected to medical exposure’

• Negotiations through the Atomic Questions Group

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Negotiations through the Atomic Questions Group expected to conclude in ?2013

• Activity to date has focused on seeking views from member states

• Danish EU Presidency draft BSS Directive published 25th

June 2012

Member States shall ensure that

1.1. Proposed Basic Safety StandardsProposed Basic Safety StandardsArticle 62 Article 62 –– Accidental and Accidental and unintended exposuresunintended exposures

(a) all reasonable measures are taken to minimise the probability and magnitude of accidental or unintended medical exposures from all medical radiological procedures, taking into account economic and social factors;

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(b) for radiotherapeutic practices the quality assurance programme includes a study of the risk of accidental or unintended exposures, commensurate with the hazard and probability of the event;

1.1. Proposed Basic Safety StandardsProposed Basic Safety StandardsArticle 62 Article 62 –– Accidental and Accidental and unintended exposures cont…..unintended exposures cont…..

(c) for all medical exposures the undertaking implements a system for the record keeping and analysis of events involving or potentially involving accidental or unintended medical exposures, commensurate with the hazard and probability of the event;

(ca) arrangements are made to inform the referrer, the patient

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and, where relevant, the practitioner about an unintended or accidental exposure and the results of the analysis;

(d) the undertaking declares as soon as possible to the

1.1. Proposed Basic Safety StandardsProposed Basic Safety StandardsArticle 62 Article 62 –– Accidental and Accidental and unintended exposures cont…..unintended exposures cont…..

competent authorities the occurrence of significant events as defined by the authorities, including the results of the investigation and the corrective measures to avoid such events.

(e) mechanisms are in place for the timely dissemination of

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information, relevant to radiation protection in medical exposure, regarding lessons learned form significant events, including the results of investigations referred to under (e).

1.1. UK ImplicationsUK Implications

• Revised BSS Directive expected 2014

Revised IR(ME)R expected 2017• Revised IR(ME)R expected 2017

• ? further then current draft of BSS Directive

not really possible – gold plating

• ? not as far as current draft of BSS Directive

not really possible – must implement Directive

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not really possible must implement Directive

2.2. EMGTI EMGTI –– DH GuidanceDH Guidance

• DH interim guidance published in Sept 2012 will need to be developed

• Further guidance for current and future IR(ME)R for RT will need to be addressed:

• Significant clinical impact

• Partial miss

• Tissue tolerance

• Clarity in reporting EMGTI is important but consistency may

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• Clarity in reporting EMGTI is important but consistency may not always be possible

• IR(ME)R 4(5) V IRR 32(6)

• Devolved Administrations (health maybe devolved to quality agencies)

3.3. HERCA HERCA -- EMGTIEMGTI

• Heads of European Radiological protection Competent Authorities

• HERCA is a voluntary association in which the Heads of Radiation Protection Authorities work together in order to identify common issues and propose practical solutions for these issues. HERCA is working on topics generally covered by provisions of the EURATOM Treaty.

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• HERCA looking to define EMGTI

• But at this stage only looking at nuclear medicine & radiology imaging.

AcknowledgementsAcknowledgements

Patient Safety in Radiotherapy

Thank YouThank You

Patient Safety in Radiotherapy Steering Group

NRLS ColleaguesInspectorate Colleagues

RTE Reporters & Coders

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RTE Reporters & Coders

Steve Ebdon-Jackson

www.hpa.org.uk/radiotherapy Una.Findlay@hpa.org.uk

Please keep reporting!Please keep reporting!