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, Total Quality Monitoring
MIDIALIS DE WOLF - GONZALEZ
Pitch
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• We are – an official high-tech spin-off company of the University of Leuven and the
University Hospitals of Leuven, Belgium
• We have – 15+ years of experience in quality assurance in medical imaging in radiology
• We are specialized in – remote and automated quality control in breast cancer screening programs
and innovative patient radiation dose monitoring
• ISO 13485 medical device manufacturer
Background
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• company structure – mix of
• private capital
• investment funds – Gemma-Frisius fund (KBC + BNP Paribas Fortis)
• university funds
– we bought all needed technology from the University of Leuven, no need for licensing
Innovation and Incubation Center KULeuven
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Products
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Patient dose monitoring
Clinical relevant patient radiation dose monitoring
QA Network
Consultancy
Centralized and automated quality assurance for any modality (strong focus on breast cancer screening)
- Breast cancer screening
- CT
- General radiology
- … Ad hoc
Stand alone applications to improve efficiency of Medical Physics Experts
and service engineers
- General Radiology
- CT
- Interventional Radiology
- Mammography
- Erica²
- BianQA Human observer performance experiments
Setup of image based clinical trials
Installation base
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• Mammography Quality Control Network – Flanders
• 150+ systems
– Canada (Ontario Breast Screening Programme) • 2014: 200 systems (DR/CR) (project: 25 systems)
– Austria • 2013: 220 systems (DR/CR) (project: 30 systems)
• Patient dose monitoring – +/- 1,000,000 studies – Non-exclusive collaboration agreement with FujiFilm Europe
Installation base
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• Standalone applications – MoniQA: Monitor Quality Assurance
• Mandatory in Ireland, Flanders, …
• Recommended by EUREF
– Erica²: Enhanced CDMAM analysis
– BianQA: Automated analysis of digital mammography phantom data
• Both mandatory in France
Products
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Patient dose monitoring
Clinical relevant patient radiation dose monitoring
Consultancy - General Radiology
- CT
- Interventional Radiology
- Mammography
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Why automated dose monitoring ?
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• Dose monitoring is often a legal obligation • Constant monitoring tool to avoid (deliberate) system abuse • Reduces potential for human error • Save technologists / radiologists time • Enables the creation of more detailed reports • Insurance against the all-mighty patients • Benchmark tool between systems • Optimisation tool • Quality management project (cfr JCI, IRMER) • Independent tool to check manufacturer, service engineer
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CE IIb
Vendor
neutral
Components
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• Physical-technical QC – Are the devices working correctly from a physical-technical point of
view ?
• Patient radiaton dosimetry – At which level are our patient dose levels compared with DRLs / the
past / other devices / …. ?
• Managment QC – Do we manage and control the workflow and can we optimize it ?
• Clinical QC – Did the operator use the system correctly ?
Components
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• Physical-technical QC – Are the devices working correctly from a physical-technical point of
view ?
• Patient radiaton dosimetry – At which level are our patient dose levels compared with DRLs / the
past / other devices / …. ?
• Managment QC – Do we manage and control the workflow and can we optimize it ?
• Clinical QC – Did the operator use the system correctly ?
Technical overview
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VM Windows Server 2008
SQL Database (Oracle)
Data receiver Analysis engine
Integration webservice
Web application
Pre-configured Virtual Machine simplified installation
Analysis engine / data receiver
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Database
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Total Quality Monitoring
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Typical workflow / easy setup
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PACS
Warning Unknown
stationname Add device
Analysis engine
Send 1 study
Typical workflow / easy setup
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PACS Analysis engine
Send all studies
Known device Perform analysis
Database
Reporting Data overview
Typical analysis
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• Depending on modality, we use… – DICOM header information
– RDSR objects
– DoseReports (using vendor specific OCR modules)
– calculation of dose values using Dance method (makes it possible to compare systems - MG)
Typical analysis
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• We extract more than only dose information – Meta-data analysis system
• PACS – Picture Archive and Communications System
• DACS – Dose Archive and Communications System
• MACS – Meta-data Archive and Communications System
– Possibility to store stripped and anonymized DICOM header
DCM
Potential extensions
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Optimisation chain
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Pre-exam
During examination
Post-exam
Optimization & Reporting
Pre - exam
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• At order entry
• Use the accumulated patient dose to decide on the used technology
• For specialists, radiologists, ….
• Possible to use webservice integration in workflow of specialist
• Future: pre-exam calculation of expected dose based on study, modality and patient specific parameters
Pre - exam
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• Several views possible (themeable, translated, …)
(only integrated browser needed)
Pre - exam
During examination
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• Protocol management
• Key for successful dose and workflow optimization
• Collection of best practices
• Web access, so accessible from the room
• General information, contrast, exposure settings, reconstruction parameters, …
• Version tracking available / report
• Can also be used during the pre-exam phase to point patients to more optimized devices
During examination
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During examination
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During examination
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During examination
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During examination
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• Simplified creation of protocol database
• Future: management of other modalities
During examination
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• Simplified connection of BodyPartExamined codes with protocols, studydescriptions
• Possible inclusion of RadLex PlayBook codes
During examination
Post - exam
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• Comparison of study specific results with statistical data
Post - exam
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• Warning system based on user defineable dose limits – Limits are based on
• used protocol
• Patient age
• Patient gender
– Limits are • send via e-mail, twitter
• stored in the database
• saved as XML files
• Warning system to inform on secondary treatment – ex. interventional procedures: generate warning when dose exceeds
certain level and follo-up treatment should start as soon as possible (treatment for burn wounds)
Post - exam
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• Integration of webservice in PACS for patient accumulated dose reporting (ex. FujiFilm PowerJacket)
Post - exam
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• Overview of patient specific studies Post - exam
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• Integrated tools
Post - exam future
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• Analysis of meta-data of 3rd party products • Visiana.com: BoneXpert
– Determine bone age from digital hand X-Ray
• Breast density measurements
Post - exam future
Optimisation reporting
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• Look for trending in dose data
• Use of web application
• Quick data overview using user-configurable dashboards
Optimisation reporting
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Optimisation reporting
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Optimisation reporting
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Optimisation reporting
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Optimisation reporting
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Optimisation reporting
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Optimisation reporting
• From simple to complicated reports
• Possibility to define template layouts according to local legislation
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Optimisation reporting
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Optimisation reporting
• Different user roles for different data access
• Possibility to export data to MS Excel compatible formats no vendor lock-in
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• localisation
Optimisation reporting
Optimisation chain - TQM
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Pre-exam
During examination
Post-exam
Optimization & Reporting
Physical – technical Quality Control
Clinical Quality Control
Physical-technical Quality Control
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• DR • detector artefact analysis (PMMA phantom / Cu filter)
• evaluate system stability
• tube management (based on accumulated tube loads) • (portable DR systems: fall analysis)
• CR • artefact analysis of Imaging Plate (IP) (comparison before and after cleaning)
• IP replacement detection based on amount of exposures
• IP sensitivity monitoring (plate ageing)
– optimal usage of RX rooms
Clinical Quality Control
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• In CT, simple dataset analysis – Analysis of …
• DoseReport / SR : for patient radiation dose monitoring • Topogram / scout : to create a small thumbnail for easy study
recognition
– Only 2 DICOM files
• Advanced dataset analysis – Receive all images and extract as much information as
possible
Clinical Quality Control
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• Analysis of every DICOM header of every original series
– Extraction of exposure information per slice
– Possibility to
• Evaluate influence of mAs or kV modulation techniques
• Evaluate used exposure parameters
Clinical Quality Control
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– Possibility to
• Evaluate influence of mAs or kV modulation techniques
Clinical Quality Control
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– Possibility to
• Evaluate potential scan overlap between series
• Overlap between consecutive series should be as small as possible
Clinical Quality Control
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– Possibility to
• Evaluate used used series and exposure parameters in combination with protocol management
• Example, method to optimize scan protocols – If in more than ex. 50% of the studies the parameters needs to
be modified, sign for
» optimization of protocol
» creation of new protocols
Clinical Quality Control
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– Possibility to
• Evaluate if the used protocol was intended to be used for this patient – Adult vs peadiatric protocols
– Warning when adult protocols are being used for peadiatric patients
Clinical Quality Control
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– Evaluate problem of patient positioning
• when using dose reduction techniques, it’s crucial that patients are positioned in the isocentre of the gantry – danger for dose increase instead of dose reduction
vertical horizontal
can be used as an alternative for missing
weight/length information
Clinical Quality Control
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– Evaluate problem of overscan in CT
• possibility to measure overscan and estimate superfluous dose
• fully automatic analysis method
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Thorax scan
Optimal scan limits
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Breasts: 0%
Lungs: 8.3%
Liver: 20%
Gallbladder: 50%
Pancreas: 50%
Intestines: 10%
Thyroid : 0%
Heart: 0% Spleen: 30%
Stomach: 25%
Kidneys: 33,3%
Uterus: 0%
Prostate Prostate: 0%
Scanned region
Optimal region
Clinical Quality Control
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– Evaluate problem of blind scanning in CT
Clinical Quality Control
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The patient becomes the phantom
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• Need for automated solution for patient dose monitoring
• Starting from an academic / medical physics background, Qaelum offers a vendor neutral and complete solution to monitor and optimize the quality and workflow in digital radiology departments, Total Quality Monitoring
• Next to advanced patient dose monitoring, this total solution includes novel types of quality control, ex. Clinical QC, and extensions to monitor the quality in general
QUESTIONS & ANSWERS
Q…A 68 www.qaelum.com - CONFIDENTIAL
FOR YOU ATTENTION
THANK YOU
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