patient dose monitoring

, Total Quality Monitoring

MIDIALIS DE WOLF - GONZALEZ

2 www.qaelum.com - CONFIDENTIAL

• 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

• 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

Products

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

- General radiology

- … Ad hoc

Stand alone applications to improve efficiency of Medical Physics Experts

and service engineers

- General Radiology

- Interventional Radiology

- Mammography

- Erica²

- BianQA Human observer performance experiments

Setup of image based clinical trials

Installation base

• 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

• 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

Patient dose monitoring

Clinical relevant patient radiation dose monitoring

Consultancy - General Radiology

- Interventional Radiology

- Mammography

www.qaelum.com - CONFIDENTIAL

Why automated dose monitoring ?

• 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

CE IIb

Vendor

neutral

Components

• 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

• 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

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

Database

Total Quality Monitoring

Typical workflow / easy setup

Warning Unknown

stationname Add device

Analysis engine

Send 1 study

Typical workflow / easy setup

PACS Analysis engine

Send all studies

Known device Perform analysis

Database

Reporting Data overview

Typical analysis

• 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

• 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

Potential extensions

Optimisation chain

Pre-exam

During examination

Post-exam

Optimization & Reporting

Pre - exam

• 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

• Several views possible (themeable, translated, …)

(only integrated browser needed)

Pre - exam

During examination

• 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

• Simplified creation of protocol database

• Future: management of other modalities

During examination

• Simplified connection of BodyPartExamined codes with protocols, studydescriptions

• Possible inclusion of RadLex PlayBook codes

During examination

Post - exam

• Comparison of study specific results with statistical data

Post - exam

• 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

• Integration of webservice in PACS for patient accumulated dose reporting (ex. FujiFilm PowerJacket)

Post - exam

• Overview of patient specific studies Post - exam

• Integrated tools

Post - exam future

• 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

• Look for trending in dose data

• Use of web application

• Quick data overview using user-configurable dashboards

• From simple to complicated reports

• Possibility to define template layouts according to local legislation

• Different user roles for different data access

• Possibility to export data to MS Excel compatible formats no vendor lock-in

• localisation

Optimisation chain - TQM

Pre-exam

During examination

Post-exam

Optimization & Reporting

Physical – technical Quality Control

Clinical Quality Control

Physical-technical Quality Control

• 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

• 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

• 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

– Possibility to

• Evaluate influence of mAs or kV modulation techniques

– Possibility to

• Evaluate potential scan overlap between series

• Overlap between consecutive series should be as small as possible

– 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

– 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

– 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

– Evaluate problem of overscan in CT

• possibility to measure overscan and estimate superfluous dose

• fully automatic analysis method

Thorax scan

Optimal scan limits

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

– Evaluate problem of blind scanning in CT

The patient becomes the phantom

• 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

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