8/12/2011
Professional Symposium
Voluntary Dose Reporting Standards
Application to all imaging modalities
• Today’s focus is on interventional fluoroscopy
– Some procedures require significant radiation dose.
– Reasonable standards are available.
– Equipment is relatively new.
• Standards based CT dose reporting is available
– Not discussed in detail today.
• Straightforward extension to other modalities
Stephen Balter, Ph.D.
– General radiography and fluoroscopy
– Mammography
Columbia University
Presented at AAPM
August 2011
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© S. Balter 2011
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Is dose tracking and reporting new?
Stakeholders
• Patients
• Patient surrogates
– Health care professionals
– Facilities
– Professional organizations
– Health and regulatory authorities
• Imaging equipment suppliers
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Why bother?
Why should I do anything?
Cancer risk to population
• It is the right thing to do
– Funding?
Operators did not know that
they inflicted these injuries
• Need to do it to stay out of court
– Malpractice insurance
• Need to do it to get paid
– CMS or other payer mandate
• Need to do it to stay out of jail
– Regulatory requirement
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Deming Cycle
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How to voluntarily monitor dose
• Local Dose Tracking Process
• Proprietary Support Processes
• Standards Based Process
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Manual Recording (Home Brew)
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Proprietary Reports
Weekly management report
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Service Exam Level Report
• Most manufacturers can supply some
form of proprietary radiation report to
a facility.
– Individual procedure reports
– Summary reports.
• Difficult to compare data from systems
supplied by different manufacturers.
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Procedure report
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Periodic summary reports
© S. Balter 2011
Standards
© S. Balter 2011
Standards Based Reporting
• Why standards
• Needed for multi-vendor environments
• Expected to meet the needs of all
stakeholders.
• Simplifies implementation of local data
management
• Enables “regional” data management
– Multi-vendor interoperability
– Market demand
– Regulatory mandate
• Standards writers
– Industry
– Customers and users
– Regulatory community
– Patients
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Local DICOM systems in Madrid
MPPS
Vano
2005
DICOM Header
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2010
MPPS via email
Vano
© S. Balter 2011
Limitations of Headers and MPPS
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OPEN STANDARDS
• DICOM image headers usually only
report data on their own images.
• No images … No data
• MPPS has limited compatibility with
facility data systems
• Proprietary fields may contain key data.
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Radiation Dose Structured Report
IEC PAS 61910-1
• DICOM object that is designed to be handled
independently from any images.
• All irradiations are reported
• Organization
Attribute : Value pairs
as defined in DICOM
• Expandable format with all public fields.
• Object to be managed & transported like
other DICOM objects
• Near real-time streaming is included in the
specification.
• Focus on fluoro guided interventions.
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© S. Balter 2011
Extract of processed RDSR I
– Includes most of projection radiography
• Two compliance levels available based
on expected doses for normal use.
• X-ray generator is the data source.
• Specification includes both network
and “sneaker-net” data transfer.
• Evolution to IEC Standard in progress
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© S. Balter 2011
Extract of processed RDSR II
Header
Name
DoB
Sex
Patient03
1949-01-20
M
WAPPLER
2010-09-14
08:50:14
Procedure reported:
Projection X-Ray
Observer Type:
Device
Device Observer Name:
AXISCATH5
Device Observer Manufacturer: WAPPLER
Device Observer Model Name:
EDISON
Device Observer Serial Number: 160106
Scope of Accumulation:
Study
Source of Dose Information:
Dosimeter
Manufacturer:
Report created:
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Irradiation Events
µGym 2
DateTime
Plane Single Plane
Gycm2
DAP Total [Gym2]
0.006972
69.7
Dose(RP) Total [Gy]
1.03154
Fluoro DAP Total [Gym2]
0.0031836
31.8
Fluoro Dose(RP) Total [Gy]
0.41676
Total Fluoro Time [s]
284
Acquisition DAP Total [Gym2]
0.0037884
37.9
Acquisition Dose(RP) Total [Gy]
0.61478
Total Acquisition Time [s]
54
RP Definition 15cm from Isocenter toward Source
© S. Balter 2011
Event Type
Acq. Protocol DAP
9:10:36 AM
9:12:54 AM
9:32:16 AM
9:34:19 AM
9:34:51 AM
9:35:52 AM
9:36:06 AM
9:36:53 AM
9:37:31 AM
9:37:52 AM
9:38:46 AM
9:38:56 AM
9:39:10 AM
9:39:23 AM
9:44:01 AM
9:44:12 AM
9:44:43 AM
9:45:00 AM
9:45:14 AM
Gy
gantry
angles
Dose (RP)
PRI
SEC
-0.1
-0.1
42.3
45.0
45.0
54.0
54.0
-23.5
-23.5
-23.5
-23.5
-23.5
-11.1
-11.1
31.0
31.0
-28.3
-28.3
-28.3
0.0
0.0
0.0
31.2
31.2
-28.9
-28.9
-18.5
-16.8
-16.8
32.7
32.7
32.7
32.7
17.4
17.4
-1.2
18.6
18.6
Fluoroscopy
FL Low Card
3.41E-05
sharp 16 4.23E-03
Fluoroscopy
FL Low Card
4.60E-06
sharp 16 6.20E-04
Fluoroscopy
FL Low Card
8.83E-05
sharp 16 1.29E-02
Fluoroscopy
FL Norm Card
3.91E-04
Sharp 16
6.59E-02
Stationary
Coro
Acquisition
High 1.04E-03
Contrast
1.66E-01
Fluoroscopy
FL Norm Card
1.84E-04
Sharp 16
3.26E-02
Stationary
Coro
Acquisition
High 8.72E-04
Contrast
1.55E-01
Fluoroscopy
FL Norm Card
2.74E-04
Sharp 16
4.50E-02
Fluoroscopy
FL Norm Card
9.06E-05
Sharp 16
1.49E-02
Stationary
Coro
Acquisition
High 4.30E-04
Contrast
7.05E-02
Fluoroscopy
FL Norm Card
4.48E-05
Sharp 16
7.09E-03
Fluoroscopy
FL Norm Card
6.13E-05
Sharp 16
9.70E-03
Fluoroscopy
FL Norm Card
5.44E-05
Sharp 16
8.61E-03
Stationary
Coro
Acquisition
High 3.61E-04
Contrast
5.72E-02
Fluoroscopy
FL Norm Card
1.04E-04
Sharp 16
1.59E-02
Stationary
Coro
Acquisition
High 5.63E-04
Contrast
8.57E-02
Fluoroscopy
FL Norm Card
1.00E-05
Sharp 16
1.52E-03
Fluoroscopy
FL Norm Card
1.24E-04
Sharp 16
1.93E-02
Stationary
Coro
Acquisition
High 5.19E-04
Contrast
8.07E-02
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patient table
FPS
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
#
69
9
75
240
101
110
83
264
94
92
59
66
68
84
86
95
9
119
101
kVP SID
77
77
90
120
107
124
123
91
90
96
88
90
90
96
92
106
93
91
96
1002
1044
1103
1165
1132
1199
1199
1145
1145
1145
1125
1125
1125
1125
1103
1103
1103
1115
1115
TL
71
73
-59
-78
-22
-22
9
8
-65
-85
-92
-71
-72
-72
14
31
-38
-38
-64
TLAT
878
869
432
703
453
466
400
378
433
415
429
452
452
452
433
464
485
485
451
TH
160
160
160
132
132
132
132
132
132
132
132
132
132
132
132
132
132
132
132
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ACTOR expectations
Purposes of dose monitoring
• Skin dose maps
• Any procedure
– Retrospective and real-time
– Detect facility variance with expected
performance.
– Detect system or operator variance with
facility norms.
• Tracking patients over multiple
procedures and facilities
• Interfaces with external databases
• Automated process control
• Interventional procedures
– Detect individual patients at risk
for tissue reactions.
– Statistical quality management
– Automated alerts
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• Collect data to obtain state of practice.
© S. Balter 2011
Dose data should be used clinically!
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Utility of dose monitoring
• Facility comparison with “regional”
performance
• Intra-facility comparisons
– Equipment
– Operators
– Technique settings
a) 2m b) 6m c) 8m d) post surgery
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Location of reference data centers
• Professional associations
Using dose measurements
When you can measure what
you are speaking about,
and express it in numbers,
you know something about it;
but when you cannot measure
it, when you cannot express it
in numbers,
your knowledge is of a meager
and unsatisfactory kind.
– Specialized requirements could impede
intra-specialty cooperation
• Payers
– Data may be affected by patient pool
• Public health agencies
– Minimal HIPAA issues
• IAEA – SAFRAD
• Regulatory
Lord Kelvin (1824-1907)
– UK “misadministration” centre
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