Joanne Cunningham Trinity College Dublin

Joanne Cunningham Trinity College Dublin snichuin@tcd.ie
Practical risk management methods in healthcare A description of prospective and retrospective risk management tools Joanne Cunningham Trinity College Dublin

REQUIRED: A Mechanic with Experience
URGENT! The conditions, equipment and tools may predispose us to failures ESTRO Lisbon J Cunningham

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 RO Literature Prospective and Retrospective
“Identification of safety issues and concerns” Quantifying Risk Managing Risk RO Literature

ROSIS - Working Towards Safer Healthcare Delivery
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 should be appropriate to expected risk e.g. flow chart for process => need good understanding of ____(area) Dublin, 14th - 17th May 2007

Methods to identify risk
ROSIS - Working Towards Safer Healthcare Delivery 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 Top-down – consider the dangers that may exist and examine how they might arise e.g. fault trees Bottom-up – Takes a component/basic event and explores how it might cause the system to fail e.g. FMEA They say; “prospective” risk management is harder than “retrospective” Once something happens, everyone knows how it should be done! Dublin, 14th - 17th May 2007

All perspectives and possibilities
ROSIS - Working Towards Safer Healthcare Delivery All perspectives and possibilities Consider scenarios from all perspectives, and consider all possibilities Dublin, 14th - 17th May 2007

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? Need to evaluate / get to know the system Risk assessment 6 Methods for Risk Identification, Analysis and Reduction 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 effect(s)? There are several analytical tools and techniques for RM which help to ensure that people do not ‘jump to solutions’ without objective analysis, the most common of which are: · Risk surveys and audits, involving: o Structured observation o Risk audit o Checklists o Interviews o Questionnaires · Untoward event reporting including claims analysis · Fault tree analysis · Flowcharting · Cause and effect analysis · Data collection, analysis and presentation o Check sheets o Graphs, scatter diagrams, histograms · Best practice bench-marking · Techniques for deciding priorities including o Criteria analysis o Impact diagrams o Pareto analysis · Force-field analysis · Project management especially error-proofing processes. Risk Assessment

Sometimes, staring you in the face...
Hazards can be a bit like Marine Iguanas Sometimes very obvious; and visible Sometimes, staring you in the face... J Cunningham ESTRO Lisbon

Some not so visible! About knowing where to look and what to look for
Bit like being a good guide! J Cunningham ESTRO Lisbon

Sometimes conditions make them easier to see;
Knowing about them helps a lot = = = information from previous hazards - -- classification systems J Cunningham ESTRO Lisbon

Some Prospective Techniques of Risk Identification
ROSIS - Working Towards Safer Healthcare Delivery 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 Many methods to help us find what we are looking for... Physical Inspections – Buildings, Machinery -- actual risks Checklists – desk based method for identification of risk – actual risks. Simple, Inexpensive, Completed by other people – inaccuracies / inconsistencies, Easy comparison with previous years , E.g. fire check-list p 51 (infection control, fire, etc), Also e.g. p 53 Organisational Charts – useful for illustrating different aspects of the company’s activities and structure. Also desk based method for identification of risk – areas of risk Organisational Charts Useful in illustrating different aspects of the organisation’s activities and structure Looks for “areas” of risk Highlight duplications, dependencies and concentrations ADAPT YOUR ORG CHART TO A SYSTEM – IHI.ORG Identify Specific Risks Dublin, 14th - 17th May 2007

Some Retrospective Techniques of Risk Identification
ROSIS - Working Towards Safer Healthcare Delivery 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 Dublin, 14th - 17th May 2007

Prospective Techniques of Risk Identification
ROSIS - Working Towards Safer Healthcare Delivery Prospective Techniques of Risk Identification Flow Charts Process Trees Failure Modes Effects Analysis (FMEA) Dr James MacKean Analytical Trees Fault Trees (FTA) Industry Some tried and tested in health care with varying successes and in RT Dublin, 14th - 17th May 2007

Procedures leading to an HDR Brachytherapy treatment
HDR Process Tree Adapted from Thomadsen et al IJROBP 2003;57(5): Procedures leading to an HDR Brachytherapy treatment QA on unit Calibration Successful Treatment Delivery Dose/time Calculation Reconstruction Application Recording Programming Planning QA Optimisation Localisation

LEVELS 2 AND 3 “Level 2 & 3” 8 56 37 141 0-4 5-9 10-19 20-29 30+ 5 35

Prospective Techniques of Risk Identification
ROSIS - Working Towards Safer Healthcare Delivery Prospective Techniques of Risk Identification Flow Charts Process Trees FMEA HAZOP Analytical Trees Fault Trees Dublin, 14th - 17th May 2007

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 Dublin, 14th - 17th May 2007

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 Dublin, 14th - 17th May 2007

Fault tree analysis (FTA)
ROSIS - Working Towards Safer Healthcare Delivery 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 Dublin, 14th - 17th May 2007

Fault Tree Symbols Dublin, 14th - 17th May 2007

From: Systems Safety for the 21st Century. R A Stephens. Figure 15.5 Dublin, 14th - 17th May 2007

Reliability / Failure Probability
ROSIS - Working Towards Safer Healthcare Delivery Reliability / Failure Probability OR Gate: Add probabilities of input events and subtract probabilities of combinations AND Gate: Multiply probabilities of input events under an AND gate to calculate probability of the output event. PA= PB+PC+PD-PBPC-PCPD-PBPD+PBPCPD PA=PBPCPD If “P”s <0.1, use PA=PB+PC+PD Dublin, 14th - 17th May 2007

0.9999 0.0001 R = –(0.99x0.99) = FP = 0.01 x 0.01 = From: Systems Safety for the 21st Century. R A Stephens. Dublin, 14th - 17th May 2007

0.9999 0.0001 R = –(0.99x0.99) = FP = 0.01 x 0.01 = So now we know how well this system operates (well, assuming our input figures are accurate!). Supposing we changed the system – if we changed the physical layout of the circuit and arranged the bulbs in series – would that affect the reliability of light? Reliability = 0.9x0.99x0.999x0.9999x = = 0.89 Failure Probability = = = 0.11 From: Systems Safety for the 21st Century. R A Stephens. Dublin, 14th - 17th May 2007

Light 1 Light 2 Dublin, 14th - 17th May 2007

Light 1 Light 2 Use of this method for comparison --- Relative values here might be of more relevance to health care Failure Probability= = = 0.13 Reliability= 0.9x0.99x0.999x0.9999x0.99x0.99 = = 0.87 Dublin, 14th - 17th May 2007

Comparison of Options Reliability = 0.89 Failure Prob. = 0.11 Light 1 Light 2 Reliability = 0.87 Failure Prob. = 0.13 Recommend that no change be made as would reduce reliability of system Can also use this method to assess sensitivity of system to changes – e.g. if put in backup power supply – then could look objectively at how beneficial that would be to the system as a whole and if it would be cost effective. Dublin, 14th - 17th May 2007

Some error producing conditions ranked in order of known effect
Risk factor Unfamiliarity with the task x 17 Time shortage x 11 Poor human:system interface x 8 Information overload Misperception of risk x 4 Inexperience - not lack of training x 3 Poor instructions or procedures Inadequate checking Disturbed sleep patterns x 1.6 Monotony and boredom x 1.1 Adapted from Vincent C. Clinical Risk Management. 2nd Ed. 2001 J Cunningham

Estimates of Human Performance Error Rates Systems Safety for the 21st Century. R A Stephens
100 10-1 10-2 10-3 10-4 10-5 10-6 Technician “seeing” an out of calibration instrument as “in tolerance” Monitor/inspector fails to recognise initial error by operator Upper limit to credibility Two-man team (one do; one check, then reverse roles) General error of omission (no control room display) Simple 4 field treatment, 30 fractions, requires 15 parameters to be set for the first tx and half this number to be changed for the remaining fields, the requirement is to set about 1000 parameters for the entire tx. Simple arithmetic errors (without re-doing calculation on separate paper) General errors of commission e.g. misread label and selected wrong switch 1 in 1 1 in 10 1 in 100 1 in 1000 1 in 10000 1 in 1 in

Fault Trees Quantification of risk: sources of probabilities: Industry-wide figures Manufacturers (esp failure of equipment) Employees / experts (subjective) Previous experience at organisation More commonly used for retrospective analysis, but have prospective applications Ekaette 2007 Risk Analysis Similar rates of estimation of probabilities by experts and the reality based on review of reports (Note once trained in probabilities) Dublin, 14th - 17th May 2007

Fault tree analysis (FTA)
ROSIS - Working Towards Safer Healthcare Delivery 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 FMEA helps to priorize failure modes; FTA helps to identify where to put barriers and checks. Fault Tree Analysis (FTA) is widely used in industry but not so widely used in medicine. A made up example of an engineering Fault Tree is shown in Slide 11. It is worth pointing out one of the major contrasts between an engineering FT and a medical FT. Engineering FTs focus on component failure. Destructive testing of many engineering components is possible and such testing can be used to provide quantitative failure rates. 60 – 80% of system failures in medicine are attributed to human factors and, clearly, these cannot be estimated in the same way as component failure. Additionally, failure rates due to human factors will depend on a number of variables such as staffing levels with respect to workload, training, etc. Adding numbers to FTs can be based on error reporting data, if properly structured, or else expert elicitation. The relationship between FTA and some other topics discussed in this course is worth emphasizing. When the FT is extended to a Root Cause Tree, the approach is analogous to a Root Cause Analysis. The difference is that the FTA is prospective, we are speculating on what could go wrong, whereas an RCA is reactive or proactive as it deals with an incident that has already occurred. The other parallel with a previously presented topic is that with Process Maps. The branches of a Fault Tree, or a Root Cause Analysis for that matter, could be viewed as part of a Process Tree designed for the specific purpose of studying error pathways. Dublin, 14th - 17th May 2007

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):

Retrospective Techniques of Risk Identification
ROSIS - Working Towards Safer Healthcare Delivery Retrospective Techniques of Risk Identification RCA – (FTA as for prospective) ECFA STEP MTO Incident reporting and investigation Dublin, 14th - 17th May 2007

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 The Facilitator The first step in a RCA is to appoint a facilitator, often the hospital’s Clinical Risk Manager, but any person who understands the RCA process can be the facilitator. The facilitator must speak with each person involved in the incident and complete a two sided table with the usual steps in the process on one side and what happened in this case on the other. This will show what steps were at variance to the normal. The discussion between the facilitator and those involved can be in a group but is ideally done on a one to one basis. The facilitator must be someone who people feel they can trust. The Team An RCA team usually consists of six to eight people, including the facilitator. There should be one person who has little understanding of or experience with Radiation Therapy, as this person sees things with no preconceived ideas or prejudices and can often challenge our intrinsic beliefs in a positive way. There must also be someone with the authority to action or champion change. Although the RCA team usually restricts itself to recommendations they have more weight if supported by someone in authority. Aclinician who knows the patient involved is a useful team member as they can add the clinical perspective. Last, but definitely not least, at least two Radiation Therapists who were involved in the incident must be included. These people clearly have the most difficult role and they must be supported through the process and never blamed. Meeting 1 At the first meeting of the team a third column is added to the two columns, in which the reason for any variance is recorded. At this stage no attempt to analyse the variance occurs. Meeting 2 At this meeting analysis of the variations occurs and recommendations for changes in processes are made. It is extremely important to put time lines and attach names to recommendations so all members of the team understand their respective responsibilities. Documentation In the formal RCA mandated by the DHS specific deidentified documentation must be returned to the DHS in a timely fashion. The DHS is not interested in personal blame, rather they need to know that suspect processes and procedures have been addressed. When to undertake a RCA As previously discussed, in some instances in Victoria RCAs are mandatory, however there is a lot to be learned even in non mandatory situations. In general a RCA is useful in any situation where there are multiple levels or processes involved in an incident. RCAs encourage us to look beyond the obvious cause of an incident and consider all factors involved.

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 Whys When 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? ...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

FTA example Adapted from Thomadsen and Li by T Knoos Dublin, 14th - 17th May 2007

ROSIS - Working Towards Safer Healthcare Delivery 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 Dublin, 14th - 17th May 2007

ECFA - Events and Conditional1 Factors Analysis
ROSIS - Working Towards Safer Healthcare Delivery ECFA - Events and Conditional1 Factors Analysis 1The word Cause is used just as often as Conditional 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 ECFA serves three main purposes in investigations: (1) assists the verification of causal chains and event sequences; (2) provides a structure for integrating investigation findings; (3) assists communication both during and on completion of the investigation. Dublin, 14th - 17th May 2007

Typical ECFA work team using PostIt and a White board
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
ROSIS - Working Towards Safer Healthcare Delivery Events and Causal Factors Analysis What, When, Who Events Causal Factors Influences Dublin, 14th - 17th May 2007

Events and Causal Factors Analysis
ROSIS - Working Towards Safer Healthcare Delivery Events and Causal Factors Analysis Causal Factor Causal Factor Event 1 Event 2 Event 3 Definite Unconfirmed Dublin, 14th - 17th May 2007

Example ECFA: ROSIS Report 25
Event: treated on incorrect isocentre Discovered: 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 screen Set-up instructions did not specify 2 targets / alert staff to fact that there was 2 targets Machine breakdown – treated on different machine with staff not familiar with set-up or patient Difficult 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 normal Insufficient staff communication Response/Suggestion: Field names were changed to reflect targets

ROSIS - Working Towards Safer Healthcare Delivery 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 Dublin, 14th - 17th May 2007

MTO – Man, Technology and Organisation analysis
ROSIS - Working Towards Safer Healthcare Delivery 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 Dublin, 14th - 17th May 2007

MTO analysis worksheet
ROSIS - Working Towards Safer Healthcare Delivery MTO analysis worksheet Dublin, 14th - 17th May 2007

ROSIS - Working Towards Safer Healthcare Delivery MTO analysis worksheet Start with the chain of events in the process Dublin, 14th - 17th May 2007

ROSIS - Working Towards Safer Healthcare Delivery MTO analysis worksheet Add the cause resulting in each event Dublin, 14th - 17th May 2007

ROSIS - Working Towards Safer Healthcare Delivery MTO analysis worksheet Identify the events that went wrong, and add these causes that led to the failure Dublin, 14th - 17th May 2007

ROSIS - Working Towards Safer Healthcare Delivery MTO analysis worksheet 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 Dublin, 14th - 17th May 2007

Investigation tools/methods
ROSIS - Working Towards Safer Healthcare Delivery 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 Dublin, 14th - 17th May 2007

Identifying RISK - Summary
ROSIS - Working Towards Safer Healthcare Delivery 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 Methods should be appropriate to expected risk e.g. flow chart for process => need good understanding of ____(area) Dublin, 14th - 17th May 2007

RISK ASSESSMENT / Risk Evaluation / Risk Ranking / Risk Rating / Risk Scoring . . . How Thin? Aims: Quantify the likelihood of loss (numerically) Allow comparison between hazards Monitor hazards Dublin, 14th - 17th May 2007

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 ; Space News interview Dublin, 14th - 17th May 2007

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 Dublin, 14th - 17th May 2007

Once you have them defined like this, you need to do something about them. Dublin, 14th - 17th May 2007

Used to determine regulatory reporting requirement and subsequent investigations

RISK CONTROL Dublin, 14th - 17th May 2007

Risk Control MOST Effective 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 Elimination – eliminate the hazard altogether Substitution – substitute with a method/item that reduces the risk / presents a lower risk – only if elimination is not possible Engineering controls or safety measures to reduce the risk (measures that protect everyone) Adminstrative controls which reduce or eliminate exposure to a hazard by adherence to procedures or instruction e.g. supervision, Personal Protective Equipment (PPE) – with appropriate training in the use and selection of PPE LEAST Effective Dublin, 14th - 17th May 2007

For Radiation Oncology...
Automation, standardization, checklists, redundancy Human Factors in the design of products and workspaces Safety Culture

Safety is no accident Simple, everyday ideas for improving quality and safety

“Quality Improvement Toolbox”
“Quality Improvement Toolbox”

Quality Improvement Tools
Quality Improvement Tools

Reason’s Model of Organisational Accidents
ROSIS - Working Towards Safer Healthcare Delivery Reason’s Model of Organisational Accidents Background conditions: Workload Supervision Communication Training/ knowledge/ ability Equipment Conditions of Work (current) Multilayered Defences Management Decision Organisational Process Latent Failures Unsafe Acts: Omissions Action slips / failures Cognitive failures (mistakes and memory lapses) Violations Active Failures No easy one-stop solution/application Lot of techniques available Find a combination to meet your needs Know the area/topic Different perspectives Analysis team from different backgrounds Ask someone not familiar with project to look through it – you might have missed the obvious The term “defense in depth” is defined in the BSS as “the application of more than one single protective measure for a given safety objective such that the objective is achieved even if one of the protective measures fail”. “Defense in depth” can be viewed as several layers of safety provisions, such as physical components and procedures. For this multilayered prevention of incidents to work, these layers need to be independent of each other. An implemented Quality Assurance program might provide the layers. Part of the QA should be to verify that this is the case. Initiating events will continue to happen. Take a critical look at the system for multilayered prevention of accidental exposures in your clinic. Go through the check-list for prevention of accidental exposures in your own clinic, and assess what might be improved. Despite all measures, accidental exposures may still occur. Be prepared! Have a response plan, with a clear list of actions and responsible officers posted in relevant places. Develop and review this periodically. Dublin, 14th - 17th May 2007

Anticipate problems Recognise hazards ALWAYS be on the lookout - Work with Awareness Learn from Failures

Dublin, 14th - 17th May 2007

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): , 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): Ekaette E, Lee RC, Cooke DL, Iftody S, Craighead P: Probabilistic Fault Tree Analysis of a Radiation Treatment System. Risk Analysis 2007, 27(6): Govindarajan R, Molero J, Tuset V, Arellano A, Ballester R, Cardenal J, Caro M, FernÃ¡ndez J, JovÃ© J, Luguera E et al: Failure Mode and Effects Analysis (FMEA) helps improve safety in radiation therapy. El anÃ¡lisis modal de fallos y efectos (AMFE) ayuda a aumentar la seguridad en radioterapia 2007, 22(6): Hamilton C, Oliver L, Coulter K: How safe is Australian radiotherapy? Australasian Radiology 2003, 47(4): 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): Kapur A, Potters L: Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department. Practical Radiation Oncology 2012, 2(2): 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 LucÃ F, Fileni A: Risk management in radiotherapy: Analysis of insurance claims. La gestione del rischio in radioterapia: Analisi del contenzioso assicurativo 2006, 111(5): Munro AJ: Hidden danger, obvious opportunity: Error and risk in the management of cancer. British Journal of Radiology 2007, 80(960): 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): 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): 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-e 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): 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: ). Int J Radiat Oncol Biol Phys 2004, 59(3):915; author reply Peiffert D, Simon JM, Eschwege F: Ã‰pinal radiotherapy accident: passed, present, future. L'accident d'Ã‰pinal : passÃ©, prÃ©sent, avenir 2007, 11(6-7): 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-S Potters L, Kapur A: Implementation of a “No Fly” safety culture in a multicenter radiation medicine department. Practical Radiation Oncology 2012, 2(1): 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): 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): Williams MV: Improving patient safety in radiotherapy by learning from near misses, incidents and errors. British Journal of Radiology 2007, 80(953):

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

Abstract Purpose: The safe delivery of radiation therapy requires multiple disciplines and interactions to perform flawlessly for each patient. Because treatment is individualized and every aspect of the patient's care is unique, it is difficult to regiment a delivery process that works flawlessly. The purpose 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 entire process of care prior, during, and after a patient's treatment course. Each component of care was broken 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 stopping rules. The NFP was introduced to place a holding pattern on treatment initiation pending reconciliation of associated stopping events. The NFP was introduced in a pilot phase using a Six-Sigma process improvement approach. Quantitative analysis on the performance of the new QCLs was performed using crystal reports in the Oncology Information Systems. Root cause analysis was conducted. .

Safety is no accident A FRAMEWORK FOR QUALITY RADIATION ONCOLOGY AND CARE – ASTRO et al
3.5.0 INGRAINING SAFETY INTO EVERYDAY PRACTICE Safety and quality initiatives are often viewed as separate from routine practice. For example, QA meetings are something that Th e Joint Commission (TJC) requires, where the leadership reacts to events in the clinic by generating rules/policies in a hierarchical manner that are (often) ignored. Th is is an unfortunate historical paradigm. A preferred approach is to ingrain safety considerations into the fabric of our clinical operations, such that it is seen as a natural component of evolving clinical practice (Figures 3.1A and B, see page 25). Th is requires a persistent acknowledgement of safety concerns by the leadership to enable an increased mindfulness among the staff . INGRAINING SAFETY INTO EVERYDAY PRACTICE

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