Patient Safety in
Radiation Oncology
William R. Hendee, PhD
Distinguished Professor
Radiology, Radiation Oncology,
Biophysics, Institute for Health
& Society
Medical College of Wisconsin
Adjunct Professor
Electrical Engineering
University of WisconsinMilwaukee
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
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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.
Endorsers:
AAMD, ABRF, ACR, ACRO, ASRT, CAPCA,
CCPM, COMP, CRCPD, JC, NPSF, PULSE,
SROA
Who Was There?
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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
Diagnosis
Prescription
Following/Evaluation
Delivery
Simulation
Verification
Planning
© WRH (March., 2011)
Radiation Therapy
is a Complex Process
Disease Treated
 Technology Employed
 Information Flow
 Human Interactions
 Treatment Evaluation
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© WRH (March., 2011)
It is a Complex Process
Consultation
Patient Information
Treatment
R&V
Prescription
Main
Hospital
Simulation
5 to 40 Fractions
Treatment
• Different types of cancer
• Different treatment
techniques
• Several technologies
Multi- vs. single-vendor
environments
QA
Different users:
• Physicians
• Physicists
• Therapists
• Dosimetrists
• IS Staff
• Administrative
Staff
Other
Sites
Treatment Plan
Technological
Innovations:
• EPID
• kV localize
• CBCT
• Other IGRT
• Research
• Clinical
activities
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
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
Errors will occur because:
Process is Complex
 Technology can Malfunction
 Handoff Misunderstandings Occur
 Humans Are Involved
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© WRH (March., 2011)
TG100
Process must be Fault-Tolerant
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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 roles in the
pursuit of improved safety:
• MDs
• Physicists
• RTTs + Dosimetrists
• Administrators
• IT
• Vendors
• Regulators
Benedick A. Fraass, PhD
Joel Goldwein MD
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, PhD
Safety Culture
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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
 Supported
 Appreciated
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-Lucian Leape MD
© WRH (March., 2011)
Safety in Radiation Therapy:
Recommendations
Return control at point of care
 As complexity increases, control
should be simplified
 Provide improved early warnings
 Vendors should address concerns
intelligibly
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© WRH (March., 2011)
Safety in Radiation Therapy:
Recommendations
Billing process must be simplified
 Recommend staffing levels (Blue
Book rev’d)
 Therapist workstation needs human
factors engineering
 Minimize cognitive clutter
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© WRH (March., 2011)
Therapist: Same issue for MD, dosimetrist, etc
UNC
Lawrence B. Marks, MD
Simple interface
Safety in Radiation Therapy:
Recommendations (cont’d)
More FMEA and RCA
 International reporting system
(SAFRON)
 As Safe as Reasonably Achievable
(ASARA)
 Return control at point of care
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© WRH (March., 2011)
Safety in Radiation Therapy:
Recommendations (cont’d)
Time outs
 Check lists, audits, SOPs
 Profession-sponsored user groups
 Safety champions
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© WRH (March., 2011)
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?
ASTRO Six Point Action Plan
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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
 Technology Assessment
 Database Management
 Safety in Radiation Therapy
 Error Reporting
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© WRH (March., 2011)
National Council for Medical
Radiation Safety and Quality
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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
 Compensation offered when at fault
 Decreased new legal claims
 Reduced time to claim resolution
 Lessened total liability costs
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Kachalia et al
Annals Int Med 2010
Enhance Communication
Require respectful communication
 Staff can halt disrespectful
communication
 Time Out procedure endorsed
 Written policies
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SRT ACTION ITEMS – D. PAVORD
Improve Information
Handoffs
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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
 Reduce work area traffic
 Policies for therapists responsibilities
 Limit persons at treatment console
 Control interactions with therapists
 Written policies
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SRT ACTION ITEMS – D. PAVORD
Success Factors
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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