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Practical risk management methods in healthcare A description of prospective and retrospective risk management tools Joanne Cunningham Trinity College.

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1 Practical risk management methods in healthcare A description of prospective and retrospective risk management tools Joanne Cunningham Trinity College Dublin

2 ESTRO Lisbon J Cunningham REQUIRED: A Mechanic with Experience URGENT!

3 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

4 Radiation Oncology Practice Standards (Tripartite Agreement)

5 Outline Identifying Risk Prospective and Retrospective Identification of safety issues and concerns Quantifying Risk Managing Risk RO Literature

6 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

7 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

8 All perspectives and possibilities

9 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

10 ESTRO Lisbon J Cunningham Sometimes, staring you in the face...

11 ESTRO Lisbon J Cunningham Some not so visible!

12 ESTRO Lisbon J Cunningham

13 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

14 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

15 Prospective Techniques of Risk Identification Flow Charts Process Trees Failure Modes Effects Analysis (FMEA) - Dr James MacKean Analytical Trees Fault Trees (FTA)

16 HDR Process Tree A dapted 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

17 Level 2 & 3 LEVELS 2 AND 3

18 Prospective Techniques of Risk Identification Flow Charts Process Trees FMEA HAZOP Analytical Trees Fault Trees

19 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

20 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

21 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

22 Fault Tree Symbols

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

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25 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 P A = P B +P C +P D -P B P C -P C P D -P B P D +P B P C P D If Ps <0.1, use P A =P B +P C +P D P A =P B P C P D

26 From: Systems Safety for the 21 st Century. R A Stephens. R = –(0.99x0.99) = FP = 0.01 x 0.01 =

27 From: Systems Safety for the 21 st Century. R A Stephens. Reliability = 0.9x0.99x0.999x0.9999x = = 0.89 R = –(0.99x0.99) = FP = 0.01 x 0.01 = Failure Probability = = =

28 Light 1 Light 2

29 Light 1 Light 2 Reliability= 0.9x0.99x0.999x0.9999x0.99x0.99 = = 0.87 Failure Probability= = = 0.13

30 Light 1 Light 2 Reliability = 0.87 Failure Prob. = 0.13 Reliability = 0.89 Failure Prob. = 0.11 Comparison of Options

31 J Cunningham Some error producing conditions ranked in order of known effect Adapted from Vincent C. Clinical Risk Management. 2 nd Ed ConditionRisk 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

32 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 in 101 in 1 1 in 1001 in in in in

33 Fault Trees Quantification of risk: sources of probabilities: Industry-wide figures Manufacturers (esp failure of equipment) Employees / experts (subjective) Previous experience at organisation

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35 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

36 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):

37 Retrospective Techniques of Risk Identification RCA – (FTA as for prospective) ECFA STEP MTO Incident reporting and investigation

38 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

39 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?

40 An expert in the 5 whys! Why did they build the Great Ocean Road so wibbly- wobbly?...Why?...BUT WHY?

41 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

42 FTA example Adapted from Thomadsen and Li by T Knoos

43 FTA example Adapted from Thomadsen and Li by T Knoos

44 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

45 ECFA - Events and Conditional 1 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 1 The word Cause is used just as often as Conditional

46 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

47 Events and Causal Factors Analysis Events What, When, Who Influences Causal Factors

48 Events and Causal Factors Analysis Definite Unconfirmed Causal Factor Event 1Event 2 Event 3 Causal Factor

49 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

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51 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

52 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

53 MTO analysis worksheet

54 Start with the chain of events in the process

55 MTO analysis worksheet Add the cause resulting in each event

56 MTO analysis worksheet Identify the events that went wrong, and add these causes that led to the failure

57 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

58 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

59 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

60 RISK ASSESSMENT / Risk Evaluation / Risk Ranking / Risk Rating / Risk Scoring... How Thin?

61 Quantifying risk Bryan OConnor, former astronaut We fooled ourselves into thinking this thing wouldnt 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 dont know. Jan ; Space News interview

62 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

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66 RISK CONTROL

67 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

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

69 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

70 Quality Improvement Toolbox

71 Quality Improvement Tools

72 Reasons 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

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

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75 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, 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): 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 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): 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: Ãpinal radiotherapy accident: passed, present, future. L'accident d'Ãpinal : passé, présent, 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):

76 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:

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84 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..

85 Safety is no accident A FRAMEWORK FOR QUALITY RADIATION ONCOLOGY AND CARE – ASTRO et al INGRAINING SAFETY INTO EVERYDAY PRACTICE


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