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What & Why Classifications
International Classification for Patient Safety WHO
RT examples
Definition
“Taxonomy is simply a classification or
ordering into groups or categories.
The key in the definition is ordering or having an
organisation behind the categories, rather than
simply a listing.”Thomadsen, B, Lin, S-W.
Taxonomic Guidance for Remedial Actionshttp://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=aps.section.1796
International Classification of Diseases Well established Classification System Late 19th Century Revised approx every 10 years
According to the ICD, in 1913 one cause of death was being
“Worn Out”Another Cause of Death =
“non-existent disease”
BUT still a valuable Epidemiological Tool
A classification or taxonomy is ... A tool for analysing and learning from
incidents particularly to identify similarities between incidents
not otherwise considered comparable; aggregate data
A means to better understand incident occurrence, prevention, and recovery reliable and valid diligently applied
WHO 2005
Reason’s Model of Organisational Accidents
Management Decision
Organisational Process
Latent Failures
Background conditions:
• Workload • Supervision • Communication •Training/ knowledge/ ability• Equipment
Conditions of Work (current)
Unsafe Acts:
• Omissions• Action slips / failures• Cognitive failures (mistakes and memory lapses)• Violations
Active Failures
Multilayered Defences
Principles and criteria a classification system must meet
World Health Organisation. Project to Develop the International Patient Safety Event Taxonomy: Updated Review of the Literature 2003-2005. Prepared by Heather Sherman PhD and Jerod Loeb PhD, Joint Commission for the Accrediation of Healthcare Organisations. Geneva: WHO. 2005.
Key elements to be considered in the design are:
The purpose of the system The types of data that are available The resources that are available to maintain the
system Facilitate analysis for learning
Straightforward (e.g. hazard identification, and summaries and descriptions), or
More analytic (e.g. trends and cluster analysis, correlations, risk analysis, causal analysis, and systems analysis)
International Classification for Patient Safety
The ICPS is conceptual based on the National Reporting and Learning System (United Kingdom) Advanced Incident Management System (Australia) Eindhoven/PRISMA-Medical Classification Model (The
Netherlands Patient Safety Event Taxonomy (United States)
Purpose: facilitate the description, comparison, measurement, monitoring, analysis and interpretation of information to improve patient care
ICPS conceptual framework
Consisting of 10 high level classes:1. Incident Type2. Patient Outcomes3. Patient Characteristics4. Incident Characteristics5. Contributing Factors/Hazards6. Organizational Outcomes7. Detection8. Mitigating Factors9. Ameliorating Actions10. Actions Taken to Reduce Risk
26th Jan 2006
CERRO
Classification
Accident, Incident, Adverse event, Near-miss
A patient safety incident is an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient.
An adverse event is an incident which results in harm to a patient.
A near miss is an incident that did not cause harm
WHO 2009 ROSIS:
an incident is defined as the incorrect delivery of radiation a near-incident / near miss is considered to be any event,
which might have resulted in an incident, but for some reason there was no incorrect irradiation.
IAEA Definitions Radiation accident as “an unintended event (operating error,
equipment failure or other mishaps) that has or may have consequences.”
Incident as “Any unintended event, including operating errors, equipment failures, initiating events, accident precursors, near misses or other mishaps, or unauthorized act, malicious or non-malicious, the consequences or potential consequences of which are not negligible from the point of view of protection or safety.”
Near miss as: “A potential significant event that could have occurred as the consequence of a sequence of actual occurrences but did not occur owing to the plant conditions prevailing at the time.”
IAEA safety glossary: Vienna. 2007.
Tripartite Agreement defn of Incident
Radiation Oncology Practice Standards (Tripartite Agreement)
Radiation Oncology Practice Standards (Tripartite Agreement)
ROSIS Classification (1)
Three main requirements:
I. Effective tool for analysis and learning – RO specific, I/N-I, detailed
II. Flexiblea. Applied to different departments and processesb. Translated into different languages
III. Incorporated into the reporting system – classified prospectively
Key Features of the ROSIS Classification Radiation Oncology Specific Method
Literature review RT incident-types from ROSIS database
Purpose Organise reports Facilitate analysis Improve safety
Scope All incidents and near-incidents relevant to an RO dept Preventative & corrective factors
Intent Maximise learning - Collect detailed information
Feasibility Incorporated into online Reporting System
To be evaluated: Analysis Sensitivity Reliability and Validity
ROSIS Classification (2)
OVERVIEW OF CLASSIFICATIONTitle Element addressed
Addressed through category/categories
1. Event
1.1 Who affected Who - Patient / Staff / Visitor
1.2 Where/When occurred Process classification
1.3 How occurred Event Description
1.4 What occurredProcess classification DescriptionRT Technique
2. Causes / Contributing factors
2. Why occurred Causes / Contributing factors
3. Detection
3.1 How Discovered Method of discovery
3.2 Where/When Discovered Stage of process of discovery
3.3 Who Discovered Discipline who discovered
4. Severity4.1 Incident/Near Incident
Treatment delivered incorrectly& no. of fractions
4.2 Actual harm & potential harm
Dose or volume discrepancy
ROSIS Classification (3)
Actual OutcomeProcess
EventCauses
Severity
Potential OutcomeyesDetection
ROSIS Process Classification“Level 1”
RT Treatment
Commissioning /
Calibration
Equipment QA/
Maintenance
Procedures / Protocols
Imaging
Simulation
Planning
Treatment Preparation
Treatment DeliveryXOR Dose
CalculationPrescription
141134
46
6
82
39 52
Where in process did it originate?What element was affected?4 “levels”
37568
141
5 35
0-4
5-9
10-19
20-29
30+
“Level 2 & 3”
TreatmentDelivery
Patient ID RT Setup
Pt Position
Accessories
Dose
Bolus
Wedge
Compensator
Shielding
Field omitted
Fld re-treatedOrientation
Field size
Collimator Angle
Gantry Angle
SSD/FSD
Isocentre
Couch height
Unobstructed field
# Missed
PositioningAids
TBI Screen
Couch angle
Extra #
Energy
Undefined
Field omitted, field re-treated
Undefined
Dose
LEVELS 2 AND 3
Analysis of Process Classification
Retrospective Analysis of Process Classification 3 persons Each classified 1st 200 ROSIS reports MS Access Database Excluded ( n=21):
Non-process reports (n=16) Non-RT specific reports (n=2) Not completed at Level 1 (n=3)
179 reports for comparison Frequency of use of categories Agreement between persons
Frequency of Categories – Level 1
Pearson Chi-Square 21.494 p<0.05
Pearson Chi-Square 8.134 p=.616
Activity Activity
All Categories
Excl. Tx Preparation
ROSIS Classification
Actual OutcomeProcess
EventCauses
Severity
Potential OutcomeyesDetection
LESSONS TO LEARN
Comparison between 4 Departments with >50 reports
0%
5%
10%
15%
20%
25%
30%
35%
% o
f d
ep
t re
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rts
Field design Mark Pt Pt positioning Record Info
Simulation
0%5%
10%15%20%25%30%35%
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f d
ept
rep
ort
s
Planning
0%5%
10%15%20%25%30%35%
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f d
ep
t re
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rts
Prescription
0%
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10%
15%
20%
25%
30%
35%
% o
f d
ep
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rts
Unclassified Calc Method Calculation
Dose Calculation
0%5%
10%15%20%25%30%35%
% o
f d
ep
t re
po
rts
Treatment Preparation
0%5%
10%15%20%25%30%35%
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f d
ept
rep
ort
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Treatment Delivery
Dept A
Dept C
Dept E
Dept J
Simulation
Prescription
Planning
Dose Calculation
Tx Preparation
Tx Delivery
Summary of Classification
Useful tool in collating, analysing and learning from incidents
Role for disciplinary-specific classifications and reporting systems
Compatibility between systems
Not a perfect science
“Table of casualties” England in the 17th Century
Some categories:
Burnt & ScaldedWolf
Cut of the StoneExecution
Fainted in a bathFalling sickness
Kings EvilLunatickSuddenly
Found dead in the streetsCancer, Gangrene & FistulaKilled by several accidentsStopping of the Stomach
References... World Health Organisation Patient Safety: Reduction of Adverse Events Through Common
Understanding and Common Reporting Tools. Towards an International Patient Safety Taxonomy: A Review of the Literature on Existing Classification Schemes for Adverse Events and Near Misses, A Draft Framework to Analyze Patient Safety Classifications, and a Draft Comparative Glossary of Patient Safety Terms. Prepared by Jerod M Loeb PhD and Andrew Chang JD MPH Joint Commission on Accrediation of Healthcare Organisations. Geneva: WHO. 2003.
World Alliance for Patient Safety. WHO Draft Guidelines for Adverse Event Reporting and Learning Systems: From Information to Action. Geneva: WHO. 2005.
World Health Organisation. Project to Develop the International Patient Safety Event Taxonomy: Updated Review of the Literature 2003-2005. Prepared by Heather Sherman PhD and Jerod Loeb PhD, Joint Commission for the Accrediation of Healthcare Organisations. Geneva: WHO. 2005.
Thomadsen, B, Lin, S-W. Taxonomic Guidance for Remedial Actions In: Henriksen K, Battles J, Marks E, Lewin D, editors. Advances in patient safety: from research to implementation. Vol. 2, Concepts and methodology. AHRQ Publication No. 05-0021-2., Rockville, MD: Agency for Healthcare Research and Quality. 2005. Available from http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=aps.section.1796. Accessed 12th July 2006;75-86.
An Organisation with a Memory: Report of an expert group on learning from adverse events in the NHS. An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS 2000.
World Health Organisation (WHO). The Conceptual Framework for the International Classification for Patient Safety (ICPS). Version 1.1. Geneva: WHO. 2009.
International Atomic Energy Agency. IAEA safety glossary: Terminology used in nuclear safety and radiation protection. Vienna. 2007.
Runciman, W, Hibbert, P, Thomson, R, Van Der Schaaf, T, Sherman, H, Lewalle, P. Towards an International Classification for Patient Safety: key concepts and terms. Int J Qual Health Care 2009;21:18-26.
W. van Vuuren / Safety Science 33 (1999) 13±29
A framework for analysing classification methods WHO 2003
“Is the purpose of the classification fully explained and is it appropriate for its intended use? Preferably, the classification should have been tested on the types of incidents and adverse events to which it will be applied.
Is the classification broad enough for the application, neither capturing too many nor too few data elements? Is it capable of identifying preventative and corrective strategies where this is relevant?
What is the conceptual approach to the classification framework? In other words, which theory in the science of human factors and error and systems failure does it reflect, if any, and is this approach consonant with the orientation of the purpose? Is the theory well established (e.g. Reason’s human error) or is it an idiosyncratic notion that may not correspond to a broader body of knowledge?
A framework for analysing classification methods WHO 2003
How feasible is the classification to implement? Can it be implemented as a paper-based and electronic on-line incident monitoring system or mapped to data collected from existing reporting systems? Is professional expertise required to apply or interpret the classification instrument? Does it use readily available data (e.g. information already contained in medical records, medicolegal files, complaints, morbidity and mortality data) and will it be readily acceptable to patient safety stakeholders? What useful purposes have been achieved using the classification? Is the classification instrument readily available and is there a cost involved? Above all, are there clear instructions that specify how the data elements are codified?
A framework for analysing classification methods WHO 2003
Is it clear how data derived from the classification are analyzed?
Is it sufficiently sensitive to differentiate similar adverse events with different contributing factors, and is this adequate for the purpose? Is it suitable for recording and tracking errors only, or can it provide detailed information to inform the development of preventative and corrective strategies?
How strong is the available evidence for reliability and validity of the classification instrument? Has it been field tested in the “real world?” How many different incident reporting systems has it been compared with? How many different users have tested the classification instrument, and did they obtain similar results?”
