Advancing Safety. Acknowledgements. Introduction. Introduction. Educational Objectives. Exciting Times. L. B. McLemore, M.S. NCCAAPM April 22, 2011

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1 Acknowledgements Advancing Safety L. B. McLemore, M.S. NCCAAPM April, 011 Keith Furutani,, Ph.D. Adil Akhtar,, M.S. Kelly Classic, CMHP Luis Fong de los Santos, Ph.D. Division of at Mayo Clinic Educational Objectives Errors: where and what (in general). Become familiar with the Safety Culture concept and some key issues identified for strengthening it. Become familiar with a few practical strategies for advancing safety. Exciting Times Introduction External Beam FFF photon beams Advanced imaging techniques (e.g., integrated kv imaging, CBCT, PET-CT) Proton Radiotherapy VMAT SBRT Brachytherapy Introduction of Cs-131 Further development in intraoperative planning Innovative implant techniques Robot-assisted Studies on the effects of edema, RBE, and dose heterogeneity 3 4 Introduction Sobering Times The New York Times articles: At V.A. Hospital, a Rogue Cancer Unit (June 0, 00) Radiation Offers new Cures, and Ways to Do Harm (Jan. 3, 0) As Technology Surges, Radiation Safeguards Lag (Jan. 6, 0) At Hearing on Radiation, Calls for Better Oversight (Feb. 6, 0) A Pinpoint Beam Strays Invisibly, Harming Instead of Healing (Dec. 8, 0) Errors & Mistakes Physicists thrive on improving processes often often leads to system complexity leads leads to increased opportunities to make an error Mechanical Human Process 60% 80% WHO Radiotherapy Risk Profile. Geneva, Switzerland: World Health Organization Yeung et al. QA in Radiotherapy: Evaluation of errors and incidents recorded over a year period. Radiother. Oncol. 74 (3): 83-1 (00). Dunscombe. What can go wrong in Radiation Treatment? Presented at AAPM/ASTRO Safety in Radiation Therapy A Call to Action. June 0 6 1

Errors & Mistakes Thomadsen et al. (003) Where? (LDR): source prep, loading, unit conversions, applicator placement What caused? (LDR): failure to detect, procedures, resources/conditions Yeung et al.

2 Errors & Mistakes Thomadsen et al. (003) Where? (LDR): source prep, loading, unit conversions, applicator placement What caused? (LDR): failure to detect, procedures, resources/conditions Yeung et al. (00) >40% attributed to errors in documentation related to data transfer or inadequate communication 40% attributed to error in patient setup WHO Radiotherapy Risk Profile (008) 3 out of 81 (~6%) risks assessed were associated with staff alone Royal College of Radiologists et al. Towards Safer Radiotherapy (008) Some of the contributing factors related to radiotherapy incidents include: Changes in the treatment process Over-reliance reliance on automated procedures Poor design and documentations of procedures Poor communication and lack of team work Training and competence issues What are we to do? Individual-based: Try harder More training and information Credentialing and competency Standards-based: Practice accreditation Certification/Licensure Consensus on minimum practice standards Increase or improve QC/QA Process-based: What now? Revise our processes Event reporting Improve product usability and safety Utilize industrial process improvement tools WHO Radiotherapy Risk Profile. Geneva, Switzerland: World Health Organization Yeung et al. QA in Radiotherapy: Evaluation of errors and incidents recorded over a year period. Radiother. Utilize industrial process improvement tools Oncol. 74 (3): 83-1 (00). Dunscombe. What can go wrong in Radiation Treatment? Presented at AAPM/ASTRO Safety in Radiation Therapy A Call to Action. June Safety Culture The Bigger Picture Over all, the implant program lacked a safety culture, the nuclear commission found. Safety Culture : Definitions Aviation Industry (good working definition) Safety Culture: refers to the extent to which individuals and groups will commit to personal responsibility for safety; act to preserve, enhance and communicate safety information; strive to actively learn, adapt and modify (both individual and organizational) behavior based on lessons learned from mistakes; and be held accountable or strive to be honored in association with these values. The New York Times At V.A. Hospital, a Rogue Cancer Unit. June 0, 00 von Thaden, T.L. and Gibbons, A.M.: The safety culture indicator scale measurement system (SCISMS). Technical Report HFD-08-03/FAA-08-. (008) Safety Culture : Definitions NRC Viewpoint Characteristics of a strong safety culture include: valuing safety over production, adhering to procedures, supporting conservative decision-making, maintaining a questioning attitude, and conducting problem identification and resolution. Safety Culture: Promoting/Strengthening Commit to safety Use procedures Conservative decision making Reporting Culture Challenge Unsafe Acts / Conditions The Learning Organization Underpinnings: Communication, Clear Priorities, and Organization NUREG/BR-0117, No. 0-04: NRC Licensee Newsletter, (Winter 00). 11 International Nuclear Safety Advisory Group, Key Practical Issues s in Strengthening Safety Culture, INSAG-1, International Atomic Energy Agency (IAEA), Vienna (00). 1

Safety Culture in Action Risk Analysis and Reporting Process-based strategies: Risk Fosters: Learning Fosters: Reporting Culture Fosters: Communication, Clear Priorities, and Organization What and

3 Safety Culture in Action Risk Analysis and Reporting Process-based strategies: Risk Fosters: Learning Fosters: Reporting Culture Fosters: Communication, Clear Priorities, and Organization What and Where did?? Retrospective (generally),, but can be Prospective FMEA (Failure Mode and Effects Analysis) What, How and Where could? prospective, and prioritize by risk Fault trees Complements FMEA OR & AND (detailed look at PFM) Notify, Schedule TRUS Process Tree: Prostate Seed Implant 3 Pre-Plan Dosim Seed Order 4 Safety Culture in Action: Process- based: Risk Analysis Tools Root cause analysis What? and Why?...Retrospective Process tree Paperwork Prep PrePlan Check 6 7 Receive, Assay Implant Procedure Source Prep for Case Global view Which branches are breaking Identify and implement solution(s) Observe for effectiveness 8 11 Post Implant CT d0 Rad Safety paperwork on d0 Post Implant Check 1 13 Post-Plan Dosim 14 1 Paperwork Prep Final Check Chart Rounds 16 Successfully Completed Treatment Threshold: # of breaks?, severity? Could be used for near-miss Requires good reporting Safety Culture in Action: Risk Analysis FMEA Identify & Implement Solution RPN = O D S Address largest RPNs 1 or higher (industry) Severity, S, if occurs and not detected (1 ) Current Process or Procedure Potential Failure Mode Identified Likelihood of non- Detection, D, in current process (1 ) Probability of Occurrence, O, in current process (1 ) Frank Rath, Tools for Developing a Quality Management Program: Proactive P tools (Process Mapping, Value Stream Mapping, Fault Tree Analysis, and Failure Mode and Effects Analysis). IJROBP,, 71(1),Supplement:S187-S10 S10 (008). ilure_mode_and_effects_analysis 1 16 Safety Culture in Action: Risk Analysis FMEA For more information: Chapters: 16,, 3, 4, 3 M. Saiful Huq et al., A Method for Evaluating Quality Assurance Needs in Radiation Therapy. IJROBP. 71(1),Supplement 1:S170-S173 S173 (008). 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). IJROBP, 71(1),Supplement:S187-S10 S10 (008). Safety Culture in Action Risk Analysis and Reporting Process-based strategies: Risk Fosters: Learning Fosters: Reporting Culture Fosters: Communication, Clear Priorities, and Organization

Safety Culture in Action: Reporting Near-Misses External Reporting ROSIS (Radiation Oncology Safety Information System) J Cunningham et al.

Louis Web-based based Error Reporting S. Mutic,, et. al. Experience with Error Reporting and Tracking Database Tool for Process Improvement in Radiation Oncology. Med. Phys.. Volume 36, Issue 6, pp.

4 Safety Culture in Action: Reporting Near-Misses External Reporting ROSIS (Radiation Oncology Safety Information System) J Cunningham et al., Radiation Oncology Safety Information System (ROSIS) Profiles of participants and the first 74 incident reports, Radiotherapy and Oncology 7 (0) Internal Reporting Washington Univ. in St. Louis Web-based based Error Reporting S. Mutic,, et. al. Experience with Error Reporting and Tracking Database Tool for Process Improvement in Radiation Oncology. Med. Phys.. Volume 36, Issue 6, pp (June 00) Princess Margaret Hospital QA review of incident reports Grace Huang, et al., Error in the delivery of radiation therapy: Results of a quality assurance review. IJROBP.. Volume 61, Issue, pp (April 00) Jean-Pierre Bissonnette and Gaylene Medlam, Trend analysis of radiation therapy incidents over seven years, Radiotherapy and Oncology 6 (0) Safety Culture in Action: Reporting Near-Misses ~ min to review and assess a report as group RTT, Dosim, Assess possible causes* Assess risk (e.g., RPN, low-med med-high) Technology associated Thanks to Luis Fong and WGEP for process flow diagram. ~ hours to develop, make, test and refine form 3 min to complete (in most instances) 1 1 * ICRP 000. Prevention of Accidental Exposure to Patients Undergoing Radiation Therapy. Oxford: ICRP 0 Frequency Frequency Where in Process Nov 0 - Mar 011 MD Rx Pre-Tx Prep Pre-Tx QA Pre-Tx Tx - Isotope is Dosim/Img in patient (App in pt) Risk Assessment of Reported Near-Miss Events Nov 0 - Mar 011 Post-Tx Risk Weighted Frequency Where in Process (Risk Weighted) Nov 0 - Mar 011 MD Rx Pre-Tx Prep Pre-Tx QA Pre-Tx Tx - Isotope is Dosim/Img in patient (App in pt) Post-Tx Safety Culture in Action: Reporting Near-Misses Challenges (our experience) Labor and time intensive Incapable of quick turn-around Risk assessment What is the threshold for must follow up Consistency in assessing risk Communication How? What? Resisting the natural tendency of wanting to problem solve during the review and assessment phase Prioritizing limited resources to address findings Feedback (or follow-up) mechanism 0 minimal small moderate serious 1 Safety Culture in Action: Solutions Solutions: often combination of Taking the switch away (use interlocks or constraints) Example: sources available for use in Brachy TPS Correcting the obvious Conditions/Resources Reducing manual entry (automation) Reducing waste (e.g., applying LEAN Standardization (hand QC/QA Education (e.g., applying LEAN-principles) (hand-offs, forms, checklists, etc.) Safety Culture in Action: Solutions Correct the obvious Minimize distractions during complex procedures (e.g., SBRT) Institute for Safe Medication Practices. Medication error prevention toolbox. Medication Safety Alert, June, 1. Available at: Accessed on April 0,

WHO Safe Surgery Saves Lives Program Hypothesized that a program to implement a checklist would reduce complications and deaths associated with surgery WHO Safe Surgery Checklist Eight pilot

thirds of the patients, on average, 1 of 6 specific safety steps was being missed during surgery Atul Gawande, The Checklist Manifesto: How to Get Things Right.

5 WHO Safe Surgery Saves Lives Program Hypothesized that a program to implement a checklist would reduce complications and deaths associated with surgery WHO Safe Surgery Checklist Eight pilot hospitals where the overall complication rates in surgery ranged from 6%-1% 4 in high income countries and among the leading hospitals in the world 4 in low or middle income countries In two-thirds thirds of the patients, on average, 1 of 6 specific safety steps was being missed during surgery Atul Gawande, The Checklist Manifesto: How to Get Things Right.. Metropolitan Books, Henry Holt and Company, LLC. First Edition (0). 6 WHO Safe Surgery Checklist project Spring 008 began implementing checklist October 008 (after checklist implemented): Rate of major complications fell by 36% Deaths fell by 47% Infections fell by almost 0% Number of patients returning to OR due to bleeding or other technical problems fell by % Atul Gawande, The Checklist Manifesto: How to Get Things Right.. Metropolitan Books, Henry Holt and Company, LLC. First Edition (0). 7 Not untrained or incapable people, it s s the inability to deliver on the volume and complexity of what we know EVERY time In a complex environment, two main difficulties: the fallibility of human memory and attention, The lull factor: people can lull themselves into skipping steps even when they remember them. Checklists seem to provide protection against such failures. Dr. Gawande: : director of WHO s s Global Challenge for Safer Surgical Care Atul Gawande, The Checklist Manifesto: How to Get Things Right.. Metropolitan Books, Henry Holt and Company, LLC. First Edition (0). 8 Checklists (items to consider/address) Define pause points (you can t t use a checklist for everything) DO-CONFIRM or READ-DO DO Should not be lengthy - items (rule of thumb) 60-0 seconds Simple and exact (organization is important) Test and refine Atul Gawande, The Checklist Manifesto: How to Get Things Right.. First Edition (0). Checklists (items to consider/address) Get those on the front-line involved in the development fosters ownership Can help address hierarchy Establish & guide open communication Intentional verbal call-outs Fosters teamwork How do you ensure the latest version is used? Gawande website: Checklist for Checklists Atul Gawande, The Checklist Manifesto: How to Get Things Right.. First Edition (0).

6 Conclusion Reality check: We ll NEVER reach zero errors / mistakes Foster Safety Culture Know your process Establish and follow procedures Analyze and Learn Use some tools (Process Tree, FMEA, FTA, etc.) Develop/Strengthen a reporting culture Maximize solutions (combine them if appropriate) Solutions don t t have to be complex: A checklist may very well be your best solution. Communication and teamwork are HUGE The most important aspect of any safety effort is to challenge assumptions about safe operations. P. Martelli and K. Roberts. Chapter 0: Primer on High Reliability Organizing in Quality and Safety in Radiotherapy.. CRC Press (011). References and Recommended Atul Gawande, The Checklist Manifesto: How to Get Things Right.. Metropolitan Books, Henry Holt and Company, LLC. First Edition (0). Quality and Safety in Radiotherapy.. CRC Press (011). Edited by: T Pawlicki,, P. B. Dunscombe,, A. J. Mundt,, P. Scalliet Frank Rath, Tools for Developing a Quality Management Program: Proactive tools (Process Mapping, Value Stream Mapping, FTA, and FMEA). IJROBP,, 71(1), Supplement: S187-S10 S10 (008). M. Saiful Huq et al., A Method for Evaluating Quality Assurance Needs in Radiation Therapy rapy. IJROBP. 71(1),Supplement 1:S170-S173 S173 (008). Bruce Thomadsen et al., Analysis of Treatment Delivery Errors in Brachytherapy Using Formal Risk Analysis Techniques. IJROBP,, 7(): (003). International Nuclear Safety Advisory Group, Key Practical Issues in Strengthening Safety Culture, INSAG-1 1,, IAEA, Vienna (00). WHO Radiotherapy Risk Profile. Geneva, Switzerland: World Health Organization The Royal College of Radiologists et al., 008. Towards Safer Radiotherapy. London: The Royal College of Radiologists References and Recommended ICRP 000. Prevention of Accidental Exposure to Patients Undergoing Radiation Therapy. Oxford: International Commission on Radiological Protection. Bruce Thomadsen and She-Woei Lin, Taxonometric Guidance for Developing Quality Assurance. IJROBP,, 71(1), Supplement: S04-S0 S0 (008). von Thaden, T.L. and Gibbons, A.M.: The safety culture indicator scale measurement system (SCISMS). Technical Report HFD-08-03/FAA-08-. (008). James Reason, Human Error. Cambridge University Press (10). James Reason, Managing the Risks of Organizational Accidents. Ashgate Publishing Limited. (17). Andrew Hopkins, Safety Culture, Mindfulness and Safe Behavior: Converging ideas? Working Paper 7. National Research Centre for OHS regulation (00). A. Hopkins, What are we to make of safe behaviour programs?. Safety Science 44(7): (006)

Therapy symposium Formal Radiation Therapy Safety Processes

Therapy symposium Formal Radiation Therapy Safety Processes M. Saiful Huq, PhD, FAAPM, FInstP, Professor and Director University of Pittsburgh Cancer Institute and UPMC CancerCenter Pittsburgh, Pennsylvania,