to err is human to learn is divine: the national system for incident reporting in radiation...

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CAMRT Representatives: Canadian Partnership for Quality Radiotherapy

Brian Liszewski, M.R.T.(T.), BSc.,Quality Assurance Coordinator, Radiation Oncology Program

Research Radiation TherapistOdette Cancer Centre, Toronto

Carol-Anne Davis RTT, ACT, MSc, FCAMRTClinical Educator

Radiation Therapy ServicesNova Scotia Cancer Centre

,

May 28 – 30, 2015, Montréal, Québec

May 28 – 30, 2015, Montréal, Québec

Disclosure Statement: With a Conflict of Interest

I have/had an affiliation, financial or otherwise, with a pharmaceutical company, medical device or communications organization, which could include:

Funding and in kind compensation from the:

Canadian Partnership Against Cancer (CPAC)

and the Canadian Institute for Health Information (CIHI)

Canadian Partnership for Quality Radiotherapy

Partenariat canadien pour la qualité en radiothérapie

CPQR:A PAN-CANADIAN QUALITY OF CARE

INITIATIVE



CPQR INITIATIVES

• Programmatic quality assurance guidance

(Accreditation)

• Technical quality control guidance

• National incident reporting and management

• Patient and family engagement

+ Pan-Canadian radiation treatment peer-review

+ Site-specific quality indicators (breast, cervix, prostate)



CPQR INITIATIVES

• Programmatic quality assurance guidance

(Accreditation)

• Technical quality control guidance

• National incident reporting and management (NSIR-RT)

• Patient and family engagement

+ Pan-Canadian radiation treatment peer-review

+ Site-specific quality indicators (breast, cervix, prostate)



THE IMPETUSTo Err is Human to learn is divine…

• Every incident provides a lesson to the individuals (or cancer centre) involved

• Collectively the incidents highlight an opportunity for systemic (or national) improvement

• Incident reporting and learning allows us to analyze the facts, to determine basic causes and to effect change



THE IMPETUSBurning Platforms:

Benefit to our profession

Increased patient awareness (NY Times)

International efforts: AAPM/ASTRO RO-ILS, ROSIS, SAFRON

Increasing interest by regulators

Window of opportunity to self-monitor



THE GOAL

To develop a system relevant to all radiation treatment programs in Canada regardless of location, size or practice orientation

To provide an online incident learning system for; sharing, aggregation and analysis of information and to improve patient safety



METHODS

SAFRON

NSIR-RT

A scoping study of taxonomies and severity classifications was conducted and a core taxonomy was derived

Oct 2013



METHODS

SAFRON

NSIR-RT

The taxonomy maintained compatibility with these other systems to facilitate future sharing of incident information across international borders

Oct 2013

METHODSA modified Delphi method usedCanadian interdisciplinary group of 27 leaders in incident learning

The group rated elements of the proposed classification as mandatory, optional or of no value

Then met in person to build consensus on the key elements for inclusion

Winter2013/14

METHODS

This delphi process defined the scope of NSIR-RT and yielded an initial version of a taxonomy and severity classification

26 core data elements were developed with ‘drop-down’ menu options for each

Spring2014

METHODSInter-user agreement of the taxonomy was examined, focusing on the 10 most subjective data elements.

32 participants with interest or expertise in incident management classified 20 incident scenarios

The taxonomy was revised based upon input from the validation process

Medical Harm

Dosimetric

Severity

Latent Medical

HarmProblem Type

Process Step

Contributing

FactorsSafety Barriers

Summer2014

TIMELINES

Release of data elements at COMP Winter School

Development of Minimum Data Set (User guide)

Beta release and launch of pilot

Winter2015

June 2015

Sept2015

http://www.caro-acro.ca/Meetings___Education/Annual_Scientific_Meetings/29th_CARO_Annual_Scientific_Meeting_September_9-12__2015_Kelowna__BC.htm

THE SYSTEMNational Uptake and Utilization2016

Accessible online

Free

Graphical User Interface

Analytic toolset for incident learning



THE SYSTEM – MODELS OF USE

NSIR-RT Repository

Risk Management System Front Line Reporting System

Secondary Data Entry



A NOTE ABOUT CONFIDENTIALITY

• Patient, health care provider and facility information is limited and de-identified prior to submission

• Data providers have full access to their own data (identifiably)and to data from other facilities (non-identifiably)

• The private communication tool permits data providers and authorized participants to discuss de-identified incidents



TAXONOMY



WHAT IS AN INCIDENTDefining an “incident”

• With Regards to Patient Safety

• An unwanted or unexpected change from normal system behaviour, which causes (actual), or has potential to cause (potential), an adverse effect.

Reportable Circumstanc

e

Near Miss None Mild Moderat

eSevere Death

None Minor Moderate

Severe

Medical Classification

Dosimetric Classification

Incident Spectrum



TAXONOMY1. Impact

1.1 Incident description - The account of the incident

1.2 Incident type – classification in terms of actual, near miss, or reportable circumstance

1.3 Acute medical harm – harm as observed at the point of the incident

1.4 Dosimetric severity – the calculated dosimetric deviation from the intended dose to tumour or OARs

1.5 Latent medical harm - harm as viewed in terms of the potential long term effects of the incident



TAXONOMY2. Discovery

2.1 Functional work area – relevant locations to the centre

2.2 Date incident was detected

2.3 Date incident occurred

2.4 Time or time period when the incident was detected

2.5 Time or time period when the incident occurred

2.6 Health care provider(s) and/or other individual(s) who detected the incident – roles of the reporter

2.7 Health care provider(s) and/or other individual(s) who were involved in the incident – roles of those involved



TAXONOMY

3. Patient

3.1 Patient year of birth

3.2 Patient month of birth

3.3 Patient gender

3.4 Diagnosis relevant to treatment – patients current diagnosis associated with the treatment affected by the incident



TAXONOMY4. Details

4.1 Process step where the incident occurred – the overarching departmental process in which the incident occurred

4.2 Process step where the incident was detected – the overarching departmental process in which the incident was detected

4.3 Problem type – The description of the event as it affects the patient. i.e. confusing documentation may lead to an incorrect shift, ultimately leading to the treatment of the “Incorrect anatomical site.”

4.4 Contributing Factors - a circumstance, action or influence which is thought to have played a part in the origin or development of an incident or to increase the risk of an incident

4.5 Number of Patients Affected



TAXONOMY5. Delivery

5.1 Radiation treatment technique

5.2 Total dose prescribed

5.3 Number of fractions prescribed

5.4 Number of fractions delivered incorrectly

5.5 Hardware involved (if relevant)

5.6 Software involved (if relevant)

5.7 Body region(s) treated

5.8 Treatment intent



TAXONOMY6. Investigation

6.1 Ameliorating actions – taken to make better or compensate harm due to a specific incident

6.2 Safety barrier(s) that failed to prevent the incident – the process steps whose primary function is to prevent an error or mistake from occurring or propagating through the radiotherapy workflow

6.3 Safety barrier(s) that prevented the incident - the process steps whose primary function is to prevent an error or mistake from occurring or propagating through the radiotherapy workflow

6.4 Actions taken or planned to reduce risk, and other recommendations



VIDEO

INCIDENT #1:

RT CASE WITH

FIRE ALARM

https://i.treatsafely.org/search-view-module/118350878

https://i.treatsafely.org/search-view-module/118350878



INCIDENT 1: RT CASE WITH FIRE ALARM

Complete Section:

• Medical Harm (Page 1)




INCIDENT CLASSIFICATIONSection: Medical Harm (Page 1)

How would you characterize the Medical Harm presented in this case?

A. NoneB. Mild C. ModerateD. SevereE. Death




INCIDENT CLASSIFICATIONSection: Medical Harm (Page 1)

How would you characterize the Medical Harm presented in this case?

A. NoneB. Mild C. ModerateD. SevereE. Death

None - patient is asymptomatic and no treatment is required

Group Discussion



IF YOU DISAGREE WITH THE CLASSIFICATION, WHY?




Complete Section:

• Dosimetric Severity (Page 1)




INCIDENT CLASSIFICATIONSection: Dosimetric Severity (Page 1)

How would you characterize the Dosimetric Severity presented in this case?

A. Not applicableB. MinorC. ModerateD. SevereE. Unknown




INCIDENT CLASSIFICATIONSection: Dosimetric Severity (Page 1)

How would you characterize the Dosimetric Severity presented in this case?

A. Not applicableB. MinorC. ModerateD. SevereE. Unknown

Minor - (180cGy/5580cGy)*100% ≈ 3.0% ≤5% tumour underdose or OAR overdose, relative to the intended doses to these structures over the course of treatment

Group Discussion







Complete Section:

• Latent Medical Harm (Page 1)




INCIDENT CLASSIFICATIONSection: Latent Medical Harm (Page 1)

How would you characterize the Latent Medical Harm presented in this case?

A. Not applicableB. YesC. No




INCIDENT CLASSIFICATIONSection: Latent Medical Harm (Page 1)

How would you characterize the Latent Medical Harm presented in this case?

A. Not applicableB. YesC. No

No - on the balance of probabilities, the incident is unlikely to be associated with the development of significant late medical harm.

Group Discussion







Complete Section:

• Problem Type (Page 2)




INCIDENT CLASSIFICATIONSection: Problem Type (Page 2)How would you characterize the

Problem Type presented in this case?

A. Treatment Volume – Wrong shift from

setup point

B. Treatment Volume – Wrong patient position

C. Treatment Volume – Wrong anatomical site

D. Dose – Wrong plan dose

E. None of these




INCIDENT CLASSIFICATIONSection: Problem Type (Page 2)How would you characterize the

Problem Type presented in this case?

A. Treatment Volume – Wrong shift from

setup point

B. Treatment Volume – Wrong patient position

C. Treatment Volume – Wrong anatomical site

D. Dose – Wrong plan dose

E. None of these

Wrong shift from setup point - a shift that is incorrect in magnitude and or direction from the shift determined in the plan

Group Discussion







Complete Section:

• Contributing Factors (Page 2)



INCIDENT 1: RT CASE WITH FIRE ALARMINCIDENT CLASSIFICATION Section: Contributing Factors (Page

2)How would you characterize the Contributing Factors presented in this case?

Program management or planning - Human resources inadequate

Program management or planning - Education or training inadequate

Program management or planning - External factors beyond programmatic control

Failure to develop an effective plan - Failure to recognize a hazard

Failure to detect a developing problem – Expectation bias

A. I agree with all 5B. I agree with 4C. I agree with 3D. I agree with 2E. I agree with oneF. I do not agree with any



INCIDENT 1: RT CASE WITH FIRE ALARMINCIDENT CLASSIFICATION Section: Contributing Factors (Page

2)Human resources inadequate - lack of staffing resources to meet expected workload demand

Education or training inadequate - lack of a curriculum framework necessary to meet the learning objectives of the task and or procedure

External factors beyond programmatic control – unspecified

Failure to recognize a hazard – the incident was caused or facilitated by the individual(s) inability to identify and or mitigate potential risks associated with a task or procedure

Expectation bias – the incident was caused or facilitated by the individuals tendency to believe, one’s expectations for an outcome, and to, discard observations that appear conflict with those expectations

Group Discussion







Complete Section:

• Safety Barriers Failed (Page 4)



INCIDENT 1: RT CASE WITH FIRE ALARMINCIDENT CLASSIFICATION Section: Safety Barrier Failed (Page

4)How would you characterize the Safety Barrier that failed presented in this case?

Hardware/Software: Image-based patient position verification

Hardware/Software: Image-based target or OAR verification

A. I agree with bothB. I agree with oneC. I do not agree with either



INCIDENT 1: RT CASE WITH FIRE ALARMINCIDENT CLASSIFICATION Section: Safety Barrier Failed (Page

4)How would you characterize the Safety Barrier that failed presented in this case?

Image-based patient position verification – the process of image guidance (megavoltage, kilovoltage, planar or volumetric) confirmation of the accurate patient positioning at the time of treatment delivery

Image-based target or OAR verification - Image-based target or OAR verification – the process of image guidance (megavoltage, kilovoltage, planar or volumetric) confirmation of the accurate field placement at the time of treatment delivery

Group Discussion







Complete Section:

• Safety Barriers Prevented (Page 4)



INCIDENT 1: RT CASE WITH FIRE ALARMINCIDENT CLASSIFICATION Section: Safety Barrier Prevented

(Page 4)How would you characterize the Safety Barrier that prevented

presented in this case?

Group Discussion• How do we record catching an incident of this type – that are caught by

processes that are not routine processes?

STRENGTH THROUGH COLLABORATION



CPQR Program Lead: Erika Brown ([email protected])

Patient

NSIR-RT Working Group:Michael MilosevicBrian LiszewskiC. Suzanne DrodgeEve-Lyne MarchandCrystal AngersJean Pierre BissonnetteErika BrownPeter DunscombeJordan HuntKrista LouieGunita MiteraKathryn MoranMatthew ParliamentSpencer RossMichael Brundage

CPQR ON THE WEB



www.cpqr.ca or www.pcqr.ca

Twitter: @cpqr_pcqr

http://www.pcqr.ca/

PROCESS MAP

Patient Assessment/Consultation

Imaging for RT planning

Treatment Planning

Pre-treatment review and verification

Treatment delivery

On-treatment quality management

Post-treatment Completion

Includes IGRT

Includes Physics Plan Check and Patient Specific QC

Includes Patient Education and Scheduling

Includes setup instructions, tattooing and contouring of normal structures

Includes contouring of OAR and Target structures, creation of the dose distribution and plan approval

Includes routine chart checks and audits

Includes final chart check, patient discharge and follow-up visits

to err is human to learn is divine: the national system for incident reporting in radiation...

Documents

quality assurance coordinator

prostate4canadian partnership

prostate5canadian partnership

canadian institute

radiation treatment

cancer cpacand

national system

analysis of information