Patient Safety in Radiation Oncology William R Hendee

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Patient Safety in Radiation Oncology William R. Hendee, Ph. D Distinguished Professor Radiology, Radiation

Patient Safety in Radiation Oncology William R. Hendee, Ph. D Distinguished Professor Radiology, Radiation Oncology, Biophysics, Institute for Health & Society Medical College of Wisconsin Adjunct Professor Electrical Engineering University of Wisconsin. Milwaukee Adjunct Professor of Radiology University of New Mexico Professor of Biomedical Engineering Marquette University Adjunct Professor of Radiology University of Colorado

2010 NYT Articles on Risks of Radiation Therapy n n n Radiation Offers New

2010 NYT Articles on Risks of Radiation Therapy n n n Radiation Offers New Cures and Ways to Do Harm – January 2010 As Technology Surges, Radiation Safeguards Lag – January 2010 When Medical Radiation Goes Awry - January 2010 Radiation Errors Reported in Missouri – February 2010 VA is Fined over Errors in Radiation in Philadelphia – March 2010 Stereotactic Radiosurgery Overdoses Harm Patients – December 2010 © WRH (March. , 2011)

Alexandra Jn-Charles, center, with her husband, Rene, and their children, died in 2007.

Alexandra Jn-Charles, center, with her husband, Rene, and their children, died in 2007.

Endorsers: AAMD, ABRF, ACRO, ASRT, CAPCA, CCPM, COMP, CRCPD, JC, NPSF, PULSE, SROA

Endorsers: AAMD, ABRF, ACRO, ASRT, CAPCA, CCPM, COMP, CRCPD, JC, NPSF, PULSE, SROA

Who Was There? n n n n 45% medical physicists 15% administrators 10. 5%

Who Was There? n n n n 45% medical physicists 15% administrators 10. 5% radiation oncologists 7% radiation therapists 2. 5% dosimetrists 2. 2% regulators 6. 8% other 11% did not respond to the demographics question © WRH (March. , 2011)

The Process of Radiation Treatment IMAGING IS CENTRAL TO EACH STEP IN THE PROCESS

The Process of Radiation Treatment IMAGING IS CENTRAL TO EACH STEP IN THE PROCESS Diagnosis Prescription Following/Evaluation Delivery Simulation Verification Planning © WRH (March. , 2011)

Radiation Therapy is a Complex Process Disease Treated n Technology Employed n Information Flow

Radiation Therapy is a Complex Process Disease Treated n Technology Employed n Information Flow n Human Interactions n Treatment Evaluation n © WRH (March. , 2011)

It is a Complex Process Consultation Patient Information Treatment R&V Prescription Simulation 5 to

It is a Complex Process Consultation Patient Information Treatment R&V Prescription Simulation 5 to 40 Fractions Treatment • Different types of cancer • Different treatment techniques • Several technologies Multi- vs. single-vendor environments Main Hospital QA Different users: • Physicians • Physicists • Therapists • Dosimetrists • IS Staff • Administrative Staff Treatment Plan Technological Innovations: • EPID • k. V localize • CBCT • Other IGRT • Research • Clinical activities Other Sites Analysis: On-line Off-line Paper vs. Paperless A lot of Information Communication CUSTOMIZED

*Fig. 11. 1 from Siochi, Information resources for radiation oncology, Ch. 11 of a

*Fig. 11. 1 from Siochi, Information resources for radiation oncology, Ch. 11 of a forthcoming book: Informatics in Radiation Oncology, G. Starkschall, B. Curran, editors. ←----------------Teach ---------------→ ←------Troubleshoot -------→ Data Flow in RO Treat Test (Process) Technologize

Human Interactions in Radiation Oncology

Human Interactions in Radiation Oncology

Errors will occur because: Process is Complex n Technology can Malfunction n Handoff Misunderstandings

Errors will occur because: Process is Complex n Technology can Malfunction n Handoff Misunderstandings Occur n Humans Are Involved n © WRH (March. , 2011)

TG 100

TG 100

Process must be Fault-Tolerant n n n n Responsibilities must be Understood Responsibilities must

Process must be Fault-Tolerant n n n n Responsibilities must be Understood Responsibilities must be Manageable Early Warnings must be Available Must Learn from others Mistakes Corrective Actions must Occur Audits must be Conducted Peer Review must Happen Process should be Accredited © WRH (March. , 2011)

What should we be doing for patient safety? We all have different but overlapping

What should we be doing for patient safety? We all have different but overlapping roles in the pursuit of improved safety: • • MDs Physicists RTTs + Dosimetrists Administrators IT Vendors Regulators Benedick A. Fraass, Ph. D

Joel Goldwein MD

Joel Goldwein MD

What should we be doing for patient safety? We all have different but overlapping

What should we be doing for patient safety? We all have different but overlapping roles in the pursuit of improved safety: • • MDs Physicists RTTs + Dosimetrists Administrators IT Vendors Regulators Benedick A. Fraass, Ph. D

Safety Culture n n n n Adhering to a culture of safety is a

Safety Culture n n n n Adhering to a culture of safety is a competency Top down enforcement of safety first Zero tolerance for short cuts All staff empowered to stop a procedure Second checks and timeouts Make sure staff do not operate outside their scope of practice Well documented change of P&P process Expectations for staff Dan Pavord, MS, DABR

In working together, everyone should be: Respected n Supported n Appreciated n -Lucian Leape

In working together, everyone should be: Respected n Supported n Appreciated n -Lucian Leape MD © WRH (March. , 2011)

Safety in Radiation Therapy: Recommendations Return control at point of care n As complexity

Safety in Radiation Therapy: Recommendations Return control at point of care n As complexity increases, control should be simplified n Provide improved early warnings n Vendors should address concerns intelligibly n © WRH (March. , 2011)

Safety in Radiation Therapy: Recommendations Billing process must be simplified n Recommend staffing levels

Safety in Radiation Therapy: Recommendations Billing process must be simplified n Recommend staffing levels (Blue Book rev’d) n Therapist workstation needs human factors engineering n Minimize cognitive clutter n © WRH (March. , 2011)

Therapist: Same issue for MD, dosimetrist, etc UNC Lawrence B. Marks, MD

Therapist: Same issue for MD, dosimetrist, etc UNC Lawrence B. Marks, MD

Simple interface

Simple interface

Safety in Radiation Therapy: Recommendations (cont’d) More FMEA and RCA n International reporting system

Safety in Radiation Therapy: Recommendations (cont’d) More FMEA and RCA n International reporting system (SAFRON) n As Safe as Reasonably Achievable (ASARA) n Return control at point of care n © WRH (March. , 2011)

Safety in Radiation Therapy: Recommendations (cont’d) Time outs n Check lists, audits, SOPs n

Safety in Radiation Therapy: Recommendations (cont’d) Time outs n Check lists, audits, SOPs n Profession-sponsored user groups n Safety champions n © WRH (March. , 2011)

What can an outside audit do for you? 28% 14% How many of you

What can an outside audit do for you? 28% 14% How many of you were in 14 -29% Fail group? From Ibbott et al, IJROBP, 71(1) 29% 25%

Still not convinced?

Still not convinced?

ASTRO Six Point Action Plan n n n Creation of an anonymous national database

ASTRO Six Point Action Plan n n n Creation of an anonymous national database for event reporting Enhance and accelerate the ASTRO/ACR Practice Accreditation Program Expand education and training programs to include intensive focus on quality and safety Develop tools for cancer patients to use in discussions with radiation oncologists Accelerate development of the IHE-RO program Advocate for passage of the CARE act © WRH (March. , 2011)

Institute for the Assessment of Medical Devices (IAMD) AAPM/MIR n Technology Assessment n Database

Institute for the Assessment of Medical Devices (IAMD) AAPM/MIR n Technology Assessment n Database Management n Safety in Radiation Therapy n Error Reporting n © WRH (March. , 2011)

National Council for Medical Radiation Safety and Quality n n n Standards for cost-effectiveness,

National Council for Medical Radiation Safety and Quality n n n Standards for cost-effectiveness, quality, safety Resource of knowledge and expertise Promote creation of national registries Guidelines for design, use and evaluation of devices Stakeholder education © WRH (March. , 2011)

Consequences of Harmful Medical Error – University of Michigan Errors disclosed to patients n

Consequences of Harmful Medical Error – University of Michigan Errors disclosed to patients n Compensation offered when at fault n Decreased new legal claims n Reduced time to claim resolution n Lessened total liability costs n Kachalia et al Annals Int Med 2010

Enhance Communication Require respectful communication n Staff can halt disrespectful communication n Time Out

Enhance Communication Require respectful communication n Staff can halt disrespectful communication n Time Out procedure endorsed n Written policies n SRT ACTION ITEMS – D. PAVORD

Improve Information Handoffs n n n Procedures for vacation coverage hand-offs More info in

Improve Information Handoffs n n n Procedures for vacation coverage hand-offs More info in treatment planning notes Planning dosimetrist present at simulation Physicians present at simulation if desired Written policies SRT ACTION ITEMS – D. PAVORD

Reduce Distractions Improve work area ergonomics n Reduce work area traffic n Policies for

Reduce Distractions Improve work area ergonomics n Reduce work area traffic n Policies for therapists responsibilities n Limit persons at treatment console n Control interactions with therapists n Written policies n SRT ACTION ITEMS – D. PAVORD

Success Factors n n n Checklists/positive written communication on any change with signed recognition

Success Factors n n n Checklists/positive written communication on any change with signed recognition (“how the pilot and copilot communicate”) Inspirational “management by walking around” Abolition of the hierarchical nature of the XRT department (Toyota Production System) Time-outs: Any member of the team can stop the assembly line and physician must be present at new starts “We all learn together” implementation of new technology Peer Review/Plan Review/Dept Review Christopher Rose, MD

The Bottom Line Is: SAFETY IS EVERYONE’S RESPONSIBILITY

The Bottom Line Is: SAFETY IS EVERYONE’S RESPONSIBILITY