Patient Dose Monitoring

, Total Quality Monitoring

MIDIALIS DE WOLF - GONZALEZ

Pitch

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

6

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


• 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

9

Patient dose monitoring

Clinical relevant patient radiation dose monitoring

Consultancy - General Radiology

- CT

- 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


PACS

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

DCM

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


During examination


During examination


During examination


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

THANK YOU


Health & Medicine

Patient Dose Monitoring