Overview of Recent Radiation
Oncology Safety Efforts
Disclosures
(by AAPM, ASTRO, and Others)
• ASTRO: Chair, Multidisciplinary QA SC, and
leader, ASTRO Safety White Paper projects
Benedick A Fraass PhD, FAAPM, FASTRO, FACR
Vice Chair for Research and Director of Medical Physics
Department of Radiation Oncology
Cedars-Sinai Medical Center
Los Angeles, CA
• AAPM: Ad Hoc Safety Coordination
Committee, Science Council, Therapy Physics
Committee, TG100 (IMRT Safety + QA),
Research Committee (Chair)
• Member, Varian Patient Safety Council
• Currently unsupported + totally unconflicted
Good Results of the NY Times Publicity:
Various National Safety-Related Initiatives
Recent RadOnc Safety Efforts
2010
2011
2012
• Publicity has led to new involvement in QA
+ safety issues within ASTRO, AAPM, ACR,
etc
• Significant improvement in cooperation
between all these organizations !
• Has led to introspection within many depts,
opening windows for analysis + efforts
Recent RadOnc Safety Efforts
2010
ACR News: Reports Demonstrate Need For National
Radiation Oncology Safety Standards:
Health Imaging (7/19/11, vanSonnenberg) reported that
according to a July article published in the Joint
Commission's Journal on Quality and Patient Safety,
nearly "50 percent of cancer patients undergo
radiotherapy, with figures estimating that roughly one in
500 experiences an error."
But these error rates compare favorably neither to "other
ultra-safe industries nor do they compare well with other
areas of medicine such as modern anesthesiology and
blood transfusion . . .”
2011
• Congressional Hearings, March 2010:
AAPM, ASTRO, etc
• Joint ACR/AAPM/ASTRO Safety Task
Force Meeting, May 2010
• FDA: June 2010 meeting w/ vendors and
users, re-evaluation of 510K process, etc.
• Miami AAPM/ASTRO Safety Meeting,
June 2010
Safety White Papers
2010
2011
• ASTRO organized Safety White Paper
effort: early February 2010
• IMRT, IGRT, SBRT, HDR, Patient-Specific
Peer Review
• Created multidisciplinary writing groups
from AAPM, ASTRO, AAMD, ASRT, ACR . .
.
• Process and review managed by ASTRO
2012
Safety White Papers
2012
2010
2011
•
•
•
•
•
•
2012
Create multidisciplinary writing groups
Determine scope, outlines, overlaps, strategy
Write something
Expert + legal review
Revise
Public comment period + review by other
orgs
• Revise
• Approvals
• Publication in PRO and Med Phys
IMRT White Paper:
“Safety Considerations for IMRT”
ASTRO Safety White Papers
IMRT * #
J Moran PhD
PRO + MedPhys
SBRT * #
T Solberg PhD
PRO in press
HDR
B Thomadsen PhD
Final edits
IGRT
D Jaffray PhD
near Expert Review
Peer Review
L Marks MD
Finalizing draft
...
* Approved by ASTRO
# Endorsed by AAPM, AAMD, ASRT, ACR
Effort supervised by Fraass, Pawlicki, Marks
IMRT White Paper: Recommendations to Guard against
Catastrophic Failures for IMRT
1. Introduction
2. Safety Concerns
3. Environmental Considerations: Culture of Safety
4. Guidance for QA: Technical Considerations
5. Collaboration between Users and Manufacturers to
Improve Safety
6. Summary
Tables on Guidance, Responsibilities, Problems, and
Recommendations to Guard against Catastrophic
Failures for IMRT
Many Orgs Have Introduced Safety Progams
2010
1
Recommended Tests and Procedures
2
3
J Moran et al
in Practical Radiation Oncology + Medical Physics
Person who performs task
Primary Review
Responsibility
Second Review
Halt a procedure if the operator is unclear about what is being done.
All
All
All
Verify the patient information, treatment site, and prescription
All
All
All
Verify correct positioning of the high dose region of isodose plan relative to
Dosimetrist
targets
Verify the recording of reference and shift information from the planning scan in Dosimetrist
patient chart (electronic or paper)
Physician
Physicist
Physicist
Therapist
Assess pre-treatment localization/portal images with respect to corresponding
Dosimetrist exports
reference images before first treatment; physician determines frequency of IGRT reference images from
techniques(35)
treatment planning system
Physician
Therapist
Verify that the correct version of the patient’s treatment plan is approved, sent to Dosimetrist exports from the Physicist
treatment management system, and used for patient-specific QA
treatment planning system
Therapists confirm against prescription for each
treatment; physician prescription should specify the
physician approved plan
Before the first treatment or for any change in treatment, perform patient-specific Physicist, dosimetrist,
Physicist
QA to guarantee that data transfer between systems is correct before patient
therapist or physics assistant
treatment begins
Therapists confirm that only fully approved plans are
used for treatment
Perform a complete chart check including review of information in treatment
management system prior to the start of any treatment and after any change in
treatment before changes are used for treatment
Visually review field apertures in treatment management system
Perform a check of dose to verify TPS calculation (measurement or
calculation using DICOM export of data from RTP system)
Physicist
Therapist
Perform a time out prior to treatment delivery.
Therapist
Second therapist
Perform a check of treatment parameters before start of and during first
Dosimetrist exported from
treatment against a fixed version of the treatment plan
TPS; verified by physicist
Includes visual verification of field apertures during first treatment
and after any change in treatment
At each fraction, verify motion of leaves (if MLC delivery) and total
monitor units
Therapist
Second therapist
Perform end-to-end testing to guarantee transfer of data among all systems
involved in imaging, planning and dose delivery (periodically and after any
software or hardware changes)
Physicist
Second physicist to review
Physicist, therapist, or
physics assistant
2011
2012
ASTRO’s “Target Safely” campaign:
• Develop questions for patients to ask on to safety issues
• Push IHE-RO to develop rigorous interoperability testing
between systems
• Enhance educational programming on safety and quality
• Push to pass the CARE Act to establish minimum education
and credentialing standards for RadOnc personnel
• A national medical error reporting system and a patient
safety database for radiation oncology
• Mandate + strengthen ACR/ASTRO accreditation
IHE-RO: Integrating the Healthcare
Enterprise – RadOnc
IHE-RO: Safety Use Cases
Treatment
Planning
OK?
Control
Computer
Yes
IMRT
Delivery
Dose
Estimator
?
Concept: Tx machine should ask for independent
estimate of dose to be delivered using current
machine setup. Get ok back. Check each Tx field
before Tx, to help prevent big dose errors
• Develop Integration Profiles to specify how standards
will be used to satisfy specific “use cases”
• Integration profiles are tested by vendors at ASTRO’s
annual Connectathon
New Blue Book:
Concentrating on Patient Safety
RadOnc Stakeholders: Vendor-User Group
2010
2011
• Initial MITA/Advamed presentation to
AAPM TPC, safety initiatives (AAPM 2010)
• 45 vendors + users @ASTRO 2010, user
safety concerns/suggestions
• AAPM 2011, concentrating on organizing
specific responses for several identified
issues
• Will meet at ASTRO 2011 to present early
progress on initiatives
2012
2010
2011
2012
AAPM, ASTRO, ACR, AAMD, ASRT, SROA
Chapters:
• Process of Care
• The Radiation Oncology Team: Work Force
Issues
• Management and Assurance of Quality:
Equipment, Facilities, QA, Quality
Management
• Culture of Safety
National System for Event- or Error Reporting
2010
2011
Conclusions
2012
• AAPM, ASTRO, FNIH, CRCPD, FDA, Congress … have
been discussing need for national event-reporting system
• Many issues:
• Confidentiality (hospitals, vendors, patients)
• Include near-misses?
• How analyze and distribute useful information?
• Include process, device + intent errors?
• Need common nomenclature
• Overlap with FDA reporting requirements?
• Make use of or create Patient Safety Organization?
• Many safety-related projects have begun,
and some are actually being completed
• We have much more work to do to really
improve safety
• Continued effort and individual vigilance
are necessary to bring the possible
improvements to each of our clinics