Practical risk management methods in healthcare A description of prospective and retrospective risk...

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Practical risk management methods in healthcareA description of prospective and retrospective risk management tools

Joanne CunninghamTrinity College Dublinsnichuin@tcd.ie

J CunninghamESTRO Lisbon

REQUIRED: A Mechanic with Experience

URGENT!

The Systems Approach

“We cannot change the human condition, but we can change the conditions under which humans work” James Reason

“Every system is perfectly designed to achieve the results it achieves”

Donald Berwick

Radiation Oncology Practice Standards (Tripartite Agreement)

Outline

Identifying Risk Prospective and Retrospective “Identification of safety issues and

concerns”

Quantifying Risk Managing Risk

RO Literature

Identifying RISK

Number of methods & techniques exist Combination required

Methods & techniques should be appropriate to expected risk e.g. flow chart for process

Ongoing programme Method should be financially sound Collaboration with other members of dept

IMAGINATION . . . EXPERIENCE . . .OPENNESS

Methods to identify risk

Desk-based vs Site-visits / Walk-arounds Quantitative vs Qualitative Broad areas of risk vs Specific risks Top-down vs Bottom-up approach Retrospective vs Prospective

All perspectives and possibilities

Know your enemy!

The key questions in identification of risk are: What can go wrong? How can it go wrong? How frequently can it go wrong? What would be the outcome?

Risk Assessment

ESTRO Lisbon

J Cunningham

Sometimes, staring you in the face...

ESTRO Lisbon

J Cunningham

Somenot so visible!

ESTRO Lisbon

J Cunningham

Some Prospective Techniques of Risk Identification

Risk surveys and audits, involving: Structured observation / Physical inspection Risk audit Checklists Interviews Questionnaires

Flow charts / Process Trees / Mapping Analytical Trees

Organisational Charts Project Evaluation Trees Fault Tree analysis

FMEA (Failure Mode Effects Analysis) HAZOP Studies (Hazard and Operability Studies)

Identify Broad Areas of Risk

Identify Specific Risks

Some Retrospective Techniques of Risk Identification

Root Cause Analysis (prospective = Fault Tree Analysis)

Events and Causal Factors Analysis = ECFA Sequential Timed Events Plotting = STEP Man Technology Organisation = MTO

Incident reporting and incident investigation

Prospective Techniques of Risk Identification

Flow Charts

Process Trees

Failure Modes Effects Analysis (FMEA)

- Dr James

MacKean

Analytical Trees

Fault Trees (FTA)

HDR Process TreeAdapted from Thomadsen et al IJROBP 2003;57(5):1492-1508

Procedures leading to an

HDR Brachytherapy

treatment

QA

on

unit

Cal

ibra

tion

Successful Treatment

Del

iver

y

Dos

e/tim

e C

alcu

latio

n

Rec

onst

ruct

ion

App

licat

ion

Rec

ordi

ng

Prog

ram

min

g

Plan

ning

QA

Opt

imis

atio

n

Loca

lisat

ion

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

Prospective Techniques of Risk Identification

Flow Charts Process Trees

FMEA HAZOP Analytical Trees

Fault Trees

Analytical Trees “Pictures of a project” Top event defined and deductive reasoning

used to develop down through the branches to specific input events

Positive Trees (Objective trees) Developed to make sure that a system works

properly Planning tools, graphic checklists, project

description “Feeder Documents” for many types of hazard

analysis e.g. FMEA Negative Trees (Fault trees)

Used for troubleshooting and To investigate system failures

Analytical Trees

Analytical Trees Displays clear thinking Forces use of deductive analysis and to think

about events that must occur at lower levels for output events to be generated

Show how relationships and interfaces occur Identifies critical paths Serve as checklists once completed Identify root causes if used for accident

analysis

Fault tree analysis (FTA)

FTA is a deductive, top-down method of analyzing system design and performance Quantify risk Trace causes Calculate sensitivity to changes in system

It involves specifying a top event to analyze, followed by identifying all of the associated elements in the system that could cause that top event to occur

Fault Tree Symbols

From: Systems Safety for the 21st Century. R A Stephens. Figure 15.5

From: Systems Safety for the 21st Century. R A Stephens. Figure 15.5

Reliability / Failure Probability

AND Gate: Multiply probabilities of input events under an AND gate to calculate probability of the output event.

OR Gate: Add probabilities of input events and subtract probabilities of combinations

PA= PB+PC+PD-PBPC-PCPD-PBPD+PBPCPD

If “P”s <0.1, use PA=PB+PC+PDPA=PBPCPD

From: Systems Safety for the 21st Century. R A Stephens.

R = 0.99+0.99–(0.99x0.99) = 0.9999

FP = 0.01 x 0.01 = 0.0001

0.9999 0.0001

From: Systems Safety for the 21st Century. R A Stephens.

Reliability = 0.9x0.99x0.999x0.9999x0.9999 = 0.8899 = 0.89

R = 0.99+0.99–(0.99x0.99) = 0.9999

FP = 0.01 x 0.01 = 0.0001

Failure Probability = 0.1+0.01+0.001+0.0001+0.0001 = 0.1112 = 0.11

0.9999 0.0001

Light 1

Light 2

Light 1

Light 2

Reliability=0.9x0.99x0.999x0.9999x0.99x0.99 = 0.8723 = 0.87

Failure Probability=0.1+0.01+0.001+0.0001+0.01+0.01 = 0.1311 = 0.13

Light 1

Light 2

Reliability = 0.87

Failure Prob. = 0.13

Reliability = 0.89

Failure Prob. = 0.11

Comparison of Options

J Cunningham

Some error producing conditions ranked in order of known effect

Adapted from Vincent C. Clinical Risk Management. 2nd Ed. 2001

Condition Risk factor

Unfamiliarity with the task x 17

Time shortage x 11

Poor human:system interface x 8

Information overload x 8

Misperception of risk x 4

Inexperience - not lack of training x 3

Poor instructions or procedures x 3

Inadequate checking x 3

Disturbed sleep patterns x 1.6

Monotony and boredom x 1.1

Estimates of Human Performance Error Rates Systems Safety for the 21st Century. R A Stephens

General error of omission (no control

room display)

Upper limit to

credibility

Two-man team (one do; one check, then

reverse roles)

Technician “seeing” an out of calibration

instrument as “in tolerance”

Monitor/inspector fails to recognise

initial error by operator

Simple arithmetic errors (without re-

doing calculation on separate paper)

General errors of commission e.g.

misread label and selected wrong switch

100 10-1 10-2 10-3 10-4 10-5 10-6

1 in 101 in 1 1 in 100 1 in 1000 1 in 10000 1 in 100000 1 in 1000000

Fault Trees

Quantification of risk: sources of probabilities: Industry-wide figures Manufacturers (esp failure of

equipment) Employees / experts (subjective) Previous experience at organisation

Fault tree analysis (FTA)

FTA is a deductive, top-down method of analyzing system design and performance Quantify risk Trace causes Calculate sensitivity to changes in system Helps to identify where to put barriers and checks

Disadvantages Time expensive Accuracy relies on accuracy of probabilities

given to events

Industry ------------------Medicine

“In industries such as nuclear power, where probabilistic risk assessment originated, most failures occur only when several systems fail concurrently, and the combination of probabilities becomes important. Most medical events, although they have several root causes and concurrent unusual situations, fail along a single branch of the fault tree”

Thomadsen & Li; IJROBP 2003;57(5):1492-1507

Retrospective Techniques of Risk Identification

RCA – (FTA as for prospective)

ECFA STEP MTO

Incident reporting and investigation

Root Cause Analysis Julie Miller The Radiographer 51;19-22

Facilitator Understanding of RCA Conducts interviews Prepares table of normal process compared with incident process

Team of 6-8 people 1 from outside RT 1 position of authority in RT at least 2 persons involved in incident Clinician (ideally treating patient)

First Meeting third column is added to the table, in which the reason for any variance

is recorded BUT no attempt to analyse the variance occurs Second Meeting

analysis of the variations occurs and recommendations for changes in processes are made, with deadlines and responsible persons

Root Cause Analysis Stephen Sutlief, AAPM 2010

Simple Framework for RCA Chronological sequence

Diagram the flow of events leading up to the incident (including the three “whys”) Ask why each event occurred until there are no more questions (or no more answers)

Cause and Effect Diagramming Identify the conditions that resulted in the adverse event or close call

Causal Statements Develop root cause and contributing factor statements, actions, and outcomes

The Three WhysWhen distilling the event narrative into an event flow diagram, it is useful to ask the three whys:

What happened? Why did it happen? What are you going to do about it?

An expert in the 5 whys! “Why did they build

the Great Ocean Road so wibbly-wobbly?”

...Why? ...Why? ...Why? ...BUT WHY?

Root Cause Analysis Stephen Sutlief, AAPM 2010

The Five Rules of Causation: Clearly show the cause and effect relationship Use specific descriptors, not vague words Identify preceding causes, not human error Identify preceding causes of procedure violations Failure to act is only casual when there is a pre-existing

duty to act

Dosimetry error

Dose calculation error

Source strength error

Wrong data (decay factor)

Wrong calibrationWrong source data

Failure of verification

Incorrect entryErreneous strength

for source dataWrong data (US vs

EU format)Failure of

verificationCalibration

error

Wrong units

Measurement error

Calculation error

Failure to enter or alter

data

Wrong source in device

Error in data entry

Discrepancy in strength between device and planning

system

FTA exampleAdapted from Thomadsen and Li

by T Knoos

Dose calculation error

Software error

Incompatible factors for

caclibration and dose calculation

Wrong patient’s

data used

Incorrect data entry

Dose specification

to wrong points

Wrong or incompatible

units

Incorrect data

transfer

Wrong dose

Wrong location of dose

distribution

Wrong dwell positions activated

Incorrect dwell times

entered

Incosistent step size

Incorrect shape of

dose distribution

Corrupt file

Software version

incompatibility

Algorithm error

Error in specification

Incorrect marker

Marker in wrong position

Inappropriate marker

Entry error

QM failure

Inaccurate source

position entry

Physicians’s error

Incorrect entry

Interpretation error

Physicians’s error

Wrong chart referenced

Data transposition

Error in transfer

FTA exampleAdapted from Thomadsen and Li

by T Knoos

Retrospective Techniques of Risk Identification

RCA – (FTA as for prospective)

ECFA Events and Causal Factors Analysis

STEP Sequential Timed Events Plotting

MTO Man Technology and Organisation Analysis

Incident reporting and investigation

ECFA - Events and Conditional1 Factors Analysis

3 main purposes in investigations Verification of causal chains and

event sequences Provides a structure for integrating

investigation findings Assists in communication both during

and on completion of the investigation

Typical ECFA work team using PostIt and a White

board

1The word Cause is used just as often as Conditional

ECFA

Practical guidelines for investigating an accident Begin early Use the guidelines Proceed logically with available

data. Use an easily updated format Correlate use of ECFA with that of

other MORT investigative tools Select the appropriate level of

detail and sequence length Make a short executive summary

chart when necessary

Typical ECFA work team using PostIt and a White

board

Events and Causal Factors Analysis

EventsWhat, When, Who

Influences Causal Factors

Events and Causal Factors Analysis

Definite

Unconfirmed

Causal Factor

Event 1 Event 2 Event 3

Causal Factor

Example ECFA: ROSIS Report 25Event: treated on incorrect isocentreDiscovered: When went to treat posterior field Description: RAO Lt Axilla field (8.8cm x 7cm) was treated with the Ant

Medial forearm prescription (5.5cm x 2cm). Both fields were 6MV energy and prescribed for 1Gy/field/fraction. There was no indication of what fields were for which target – all fields were displayed equally in the same box, with nothing to distinguish a field for Target 1 from a field for Target 2.

Causes:R&V Fields not adequately named for two targets e.g Rt Ant Obliq, RAO2, Ant Field names not fully visible on screenSet-up instructions did not specify 2 targets / alert staff to fact that there was 2

targetsMachine breakdown – treated on different machine with staff not familiar with

set-up or patientDifficult patient (v. impatient & excitable child, 7 y.o.)Unusual and heavy workload and stressful situation (machine breakdown)Excess staff (6-7 vs 4-5)Fields treated in different sequence to normalInsufficient staff communicationResponse/Suggestion: Field names were changed to reflect targets

Systemic condtions

Contributing factors

Contributing factors

Primary events

Systemic condtions

Systemic factors

Treatment unit broke down

Patient changed

treatment unit

Patient positioned on

couchBeam selected

Beam positioned incorrectly

Treated wrong target/isocenter

Complicated setup

Too many staff

Heavy workload

Management or supervisor

failure

Field names confusing

Field/target connection

missing

R/V design flaw

Patient difficult

Unclear setup

instructions

Lack of equipment

Beam positioned incorrectly

Lack of communication

Staff not familiar w

patient

Observation failure

Retrospective Techniques of Risk Identification

RCA – (FTA as for prospective)

ECFA Events and Causal Factors Analysis

STEP Sequential Timed Events Plotting

MTO Man Technology and Organisation Analysis

Incident reporting and investigation

MTO – Man, Technology and Organisation analysis

Using event and cause diagram

Describing how events have deviated from praxis

Barrier analysis by identifying technological and organisational barriers that have failed

MTO analysis worksheet

Causes

Events

DeviationNormal

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MTO analysis worksheet

Causes

Events

DeviationNormal

Ba

rrie

r a

na

lysis

Ba

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na

lysis

Eve

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Start with the chain of events in the process

MTO analysis worksheet

Causes

Events

DeviationNormal

Ba

rrie

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na

lysis

Ba

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Eve

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aly

sis

Add the cause resulting in each event

MTO analysis worksheet

Causes

Events

DeviationNormal

Ba

rrie

r a

na

lysis

Ba

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lysis

Eve

nts

an

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Identify the events that went wrong, and add these causes that led to the failure

MTO analysis worksheet

Causes

Events

DeviationNormal

Ba

rrie

r a

na

lysis

Ba

rrie

r a

na

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Eve

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Add the barriers that actually failed or was missing during the accident or incident

The final step is to identify and present actions to avoid a new occurrence

Investigation tools/methods

Sequencing tools Events and Conditional Factors Analysis - ECFA Sequential timed events plotting - STEP

Hypothesis tools Fault Tree Analysis – FTA Man, Technology and Organisation analysis –

MTO Failure Modes and Effects Analysis – FMEA Hazard And OPerability study - HAZOP

Identifying RISK - Summary

Number of methods & techniques exist Combination required

Methods & techniques should be appropriate to expected risk e.g. flow chart for process

Ongoing programme Method should be financially sound Collaboration with other members of dept

IMAGINATION . . . EXPERIENCE . . .OPENNESS

RISK ASSESSMENT

/ Risk Evaluation / Risk Ranking / Risk Rating / Risk Scoring . . .

How Thin?

Quantifying risk

Bryan O’Connor, former astronaut

“We fooled ourselves into thinking this thing wouldn’t crash. When I was in astronaut training I asked ‘what is the likelihood of another accident?’ The answer I got was: 1 in 10,000*. The ‘*’ meant: ‘we don’t know’.”

Jan 10 1996; Space News interview

Risk Assessment

Different methods in use – likelihood x severity; likelihood x detection x severity; (type + severity) x likelihood x number

affected

Relies on historical data to predict future events

Likelihood of Recurrence

Outcome and Scope

Critical 5

Major 4

Moderate 3

Minor 2

Trivial 1

Certain

5

5x5

5x4

5x3

5x2

5x1

Very Likely

4

4x5

4x4

4x3

4x2

4x1

Possible

3

3x5

3x4

3x3

3x2

3x1

Unlikely

2

2x5

2x4

2x3

2x2

1x2

Highly Unlikely

1

1x5

1x4

1x3

1x2

1x1

Very

High Risk

High Risk

Medium Risk

Low Risk

RISK CONTROL

Risk Control

Hierarchy of Actions: Elimination Substitution Engineering controls or safety measures Administrative controls which reduce or

eliminate exposure to a hazard by adherence to procedures or instruction

Personal Protective Equipment (PPE)

Health and Safety Authority; Ireland

Defence in Depth

MOST Effective

LEAST Effective

For Radiation Oncology...

Automation, standardization, checklists, redundancy

Human Factors in the design of products and workspaces

Safety Culture

Safety is no accident

https://www.astro.org/uploadedFiles/Main_Site/Clinical_Practice/Patient_Safety/Blue_Book/SafetyisnoAccident.pdf

Simple, everyday ideas for improving quality and safety

www.treatsafely.org“Quality Improvement

Toolbox”

www.ihi.orgQuality

Improvement Tools

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

Recognise hazards

ALWAYS be on the lookout - Work with Awareness

Anticipate problems

Learn from Failures

Further Reading:1. DeRosier J, Stalhandske E, Bagian JP, Nudell T: Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective

risk analysis system. The Joint Commission journal on quality improvement 2002, 28(5):248-267, 209.2. Dunscombe PB, Ekaette EU, Lee RC, Cooke DL: Taxonometric Applications in Radiotherapy Incident Analysis. International Journal of Radiation Oncology Biology

Physics 2008, 71(1 SUPPL.).3. Ekaette EU, Lee RC, Cooke DL, Kelly K-L, Dunscombe PB: Risk analysis in radiation treatment: Application of a new taxonomic structure. Radiotherapy and

Oncology 2006, 80(3):282-287.4. Ekaette E, Lee RC, Cooke DL, Iftody S, Craighead P: Probabilistic Fault Tree Analysis of a Radiation Treatment System. Risk Analysis 2007, 27(6):1395-1410.5. Govindarajan R, Molero J, Tuset V, Arellano A, Ballester R, Cardenal J, Caro M, Fernández J, Jové J, Luguera E et al: Failure Mode and Effects Analysis (FMEA)

helps improve safety in radiation therapy. El análisis modal de fallos y efectos (AMFE) ayuda a aumentar la seguridad en radioterapia 2007, 22(6):299-309.6. Hamilton C, Oliver L, Coulter K: How safe is Australian radiotherapy? Australasian Radiology 2003, 47(4):428-433.7. Huq MS, Fraass BA, Dunscombe PB, Gibbons Jr JP, Ibbott GS, Medin PM, Mundt A, Mutic S, Palta JR, Thomadsen BR et al: A Method for Evaluating Quality Assurance

Needs in Radiation Therapy. International Journal of Radiation Oncology Biology Physics 2008, 71(1 SUPPL.).8. Israelski EW, Muto WH: Human factors risk management as a way to improve medical device safety: a case study of the therac 25 radiation therapy

system. Jt Comm J Qual Saf 2004, 30(12):689-695.9. Kapur A, Potters L: Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department . Practical Radiation Oncology

2012, 2(2):86-96.10. Lee R, Kelly K-L, Newcomb C, Cooke D, Ekaette E, Craighead P, Dunscombe P: Quantitative Approaches to Patient Safety: Research in Risk Analysis and Risk

Management as Applied to Radiotherapy. HTA Initiative #15 Alberta Heritage Fund for Medical Research 2004.11. Lucà F, Fileni A: Risk management in radiotherapy: Analysis of insurance claims. La gestione del rischio in radioterapia: Analisi del contenzioso assicurativo

2006, 111(5):733-740.12. Munro AJ: Hidden danger, obvious opportunity: Error and risk in the management of cancer. British Journal of Radiology 2007, 80(960):955-966.13. Nakajima K, Kurata Y, Takeda H: A web-based incident reporting system and multidisciplinary collaborative projects for patient safety in a Japanese

hospital. Quality and Safety in Health Care 2005, 14(2):123-129.14. Nuckols TK, Bell DS, Liu H, Paddock SM, Hilborne LH: Rates and types of events reported to established incident reporting systems in two US hospitals .

Quality and Safety in Health Care 2007, 16(3):164-168.15. Olson AC, Wegner RE, Scicutella C, Heron DE, Greenberger JS, Huq MS, Bednarz G, Flickinger JC: Quality Assurance Analysis of a Large Multicenter Practice:

Does Increased Complexity of Intensity-Modulated Radiotherapy Lead to Increased Error Frequency? International Journal of Radiation Oncology*Biology*Physics 2012, 82(1):e77-e82.

16. Ostrom LT, Rathbun P, Cumberlin R, Horton J, Gastorf R, Leahy TJ: Lessons learned from investigations of therapy misadministration events. International Journal of Radiation Oncology Biology Physics 1996, 34(1):227-234.

17. Patton GA: In regard to Thomadsen et al.: Analysis of treatment delivery errors in brachytherapy using formal risk analysis techniques (Int J Radiat Oncol Biol Phys 2003;57:1492-1508). Int J Radiat Oncol Biol Phys 2004, 59(3):915; author reply 915-916.

18. Peiffert D, Simon JM, Eschwege F: Épinal radiotherapy accident: passed, present, future. L'accident d'Épinal : passé, présent, avenir 2007, 11(6-7):309-312.

19. Peter BD, Edidiong UE, Robert CL, David LC: Taxonometric Applications in Radiotherapy Incident Analysis. International Journal of Radiation Oncology, Biology, Physics 2008, 71(1):S200-S203.

20. Potters L, Kapur A: Implementation of a “No Fly” safety culture in a multicenter radiation medicine department . Practical Radiation Oncology 2012, 2(1):18-26.

21. Rath F: Tools for Developing a Quality Management Program: Proactive Tools (Process Mapping, Value Stream Mapping, Fault Tree Analysis, and Failure Mode and Effects Analysis). International Journal of Radiation Oncology Biology Physics 2008, 71(1 SUPPL.).

22. Scorsetti M, Signori C, Lattuada P, Urso G, Bignardi M, Navarria P, Castiglioni S, Mancosu P, Trucco P: Applying failure mode effects and criticality analysis in radiotherapy: Lessons learned and perspectives of enhancement. Radiotherapy and Oncology 2010, 94(3):367-374.

23. Thomadsen B, Lin SW, Laemmrich P, Waller T, Cheng A, Caldwell B, Rankin R, Stitt J: Analysis of treatment delivery errors in brachytherapy using formal risk analysis techniques. Int J Radiat Oncol Biol Phys 2003, 57(5):1492-1508.

24. Williams MV: Improving patient safety in radiotherapy by learning from near misses, incidents and errors . British Journal of Radiology 2007, 80(953):297-301.

Eric C. Ford, Ray Gaudette, Lee Myers, Bruce Vanderver, Lilly Engineer, Richard Zellars, Danny Y. Song, John Wong, Theodore L. DeWeese, Evaluation of Safety in a Radiation Oncology Setting Using Failure Mode and Effects Analysis, International Journal of Radiation Oncology*Biology*Physics, Volume 74, Issue 3, 1 July 2009, Pages 852-858

Julian R. Perks, Sinisa Stanic, Robin L. Stern, Barbara Henk, Marsha S. Nelson, Rick D. Harse, Mathew Mathai, James A. Purdy, Richard K. Valicenti, Allan D. Siefkin, Allen M. Chen, Failure Mode and Effect Analysis for Delivery of Lung Stereotactic Body Radiation Therapy, International Journal of Radiation Oncology*Biology*Physics, Volume 83, Issue 4, 15 July 2012, Pages 1324-1329

Mario Ciocca, Marie-Claire Cantone, Ivan Veronese, Federica Cattani, Guido Pedroli, Silvia Molinelli, Viviana Vitolo, Roberto Orecchia, Application of Failure Mode and Effects Analysis to Intraoperative Radiation Therapy Using Mobile Electron Linear Accelerators, International Journal of Radiation Oncology*Biology*Physics, Volume 82, Issue 2, 1 February 2012, Pages e305-e311

Danielle N. Margalit, Yu-Hui Chen, Paul J. Catalano, Kenneth Heckman, Todd Vivenzio, Kristopher Nissen, Luciant D. Wolfsberger, Robert A. Cormack, Peter Mauch, Andrea K. Ng, Technological Advancements and Error Rates in Radiation Therapy Delivery, International Journal of Radiation Oncology*Biology*Physics, Volume 81, Issue 4, 15 November 2011, Pages e673-e679

Lakshmi Santanam, Ryan S. Brame, Andrew Lindsey, Todd Dewees, Jon Danieley, Jason Labrash, Parag Parikh, Jeffrey Bradley, Imran Zoberi, Jeff Michalski, Sasa Mutic, Eliminating Inconsistencies in Simulation and Treatment Planning Orders in Radiation Therapy, International Journal of Radiation Oncology*Biology*Physics, Available online 8 May 2012

Anthony Arnold, Geoff P. Delaney, Lynette Cassapi, Michael Barton, The Use of Categorized Time-Trend Reporting of Radiation Oncology Incidents: A Proactive Analytical Approach to Improving Quality and Safety Over Time, International Journal of Radiation Oncology*Biology*Physics, Volume 78, Issue 5, 1 December 2010, Pages 1548-1554

Frank Rath, Tools for Developing a Quality Management Program: Proactive Tools (Process Mapping, Value Stream Mapping, Fault Tree Analysis, and Failure Mode and Effects Analysis), International Journal of Radiation Oncology*Biology*Physics, Volume 71, Issue 1, Supplement, 1 May 2008, Pages S187-S190

Lawrence B. Marks, Christopher M. Rose, James A. Hayman, Timothy R. Williams, The Need for Physician Leadership in Creating a Culture of Safety, International Journal of Radiation Oncology*Biology*Physics, Volume 79, Issue 5, 1 April 2011, Pages 1287-1289

Yaacov Richard Lawrence, Michal A. Whiton, Zvi Symon, Evan J. Wuthrick, Laura Doyle, Amy S. Harrison, Adam P. Dicker, Quality Assurance Peer Review Chart Rounds in 2011: A Survey of Academic Institutions in the United States, International Journal of Radiation Oncology*Biology*Physics, Volume 84, Issue 3, 1 November 2012, Pages 590-595

Eric E. Klein, Balancing the Evolution of Radiotherapy Quality Assurance: In Reference to Ford et al., International Journal of Radiation Oncology*Biology*Physics, Volume 74, Issue 3, 1 July 2009, Pages 664-666

Eric C. Ford, Stephanie Terezakis, How Safe Is Safe? Risk in Radiotherapy, International Journal of Radiation Oncology*Biology*Physics, Volume 78, Issue 2, 1 October 2010, Pages 321-322

Steven J Goetsch, Risk analysis of Leksell Gamma Knife Model C with automatic positioning system, International Journal of Radiation Oncology*Biology*Physics, Volume 52, Issue 3, 1 March 2002, Pages 869-877

System Safety for the 21st Century; Richard A. Stephens. Wiley Interscience, New Jersey; 2004. Risk Analysis, Assessment and Management; Jake Ansell and Frank Wharton; Wiley, London; 1992.VA Health Care Failure Mode and Effects Analysis HFMEA™ - available at:

http://www.patientsafety.gov/SafetyTopics/HFMEA/HFMEA_JQI.pdf

AbstractPurpose: The safe delivery of radiation therapy requires multiple disciplines and interactions toperform flawlessly for each patient. Because treatment is individualized and every aspect of thepatient's care is unique, it is difficult to regiment a delivery process that works flawlessly. Thepurpose of this study is to describe one safety-directed component of our quality program called the“No Fly Policy” (NFP).Methods and Materials: Our quality assurance program for radiation therapy reviewed the entireprocess of care prior, during, and after a patient's treatment course. Each component of care wasbroken down and rebuilt within a matrix of multidisciplinary safety quality checklists (QCL).The QCL process map was subsequently streamlined with revised task due dates and stoppingrules. The NFP was introduced to place a holding pattern on treatment initiation pendingreconciliation of associated stopping events. The NFP was introduced in a pilot phase using aSix-Sigma process improvement approach. Quantitative analysis on the performance of the newQCLs was performed using crystal reports in the Oncology Information Systems. Root causeanalysis was conducted..

Safety is no accident A FRAMEWORK FORQUALITY RADIATIONONCOLOGY AND CARE – ASTRO et al

INGRAINING SAFETY INTO EVERYDAY PRACTICE