Radiation Dose Monitoring Sectra DoseTrack and trends

1. Radiation Dose Monitoring SectraDoseTrack and trends

2. David Boissonault Solutions Consultant Petra Granlund Product Marketing Manager Jeremy Koscielny Solutions Consultant

3. Agenda • SectraDoseTrack and Trends • Joint Commission • Demo & Hands On

4. Why is radiationdosemonitoringsuch a hot topic?

5. The increaseofradiation from medicalimaging has doubled the last decadesdue to advanceddiagnostics 1980 2006 Consumer 2% Consumer 2% Medical 48% Medical 15% Background 83% Effectiveaverageradiationdose per capita 3.6 6.2 mSv Background 50% Source: National Council on Radiation Protection and Measurement, “Ionizing Radiation Exposure of the Population of the United States: NCRP REPORT No. 160,” Radiation Protection Dosimetry, vol. 136, no. 2, 2009.

6. X 20 The increased radiation exposure, severe incidents and studies indicating increased cancer risks generates a hot topic of discussion 1 3 Recent studies indicate great association between exposure and cancer X 3 Severe incidents the latest decades1 Growth of number of CT, nuclear, and fluoroscopy exams the last 25 years0 Academical studies • Risk of developing cancer is 24% higher if you are exposed for a CT scan in your first 19 years in life4 • The risk for leukemia or brain tumor is tripled if exposed for a CT in childhood5 • 29,000 cancers are estimated to occur due to examinations performed in the US in 2007 alone6 2 (4) J. D. Mathewset al, “Cancer risk in 680 000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians,” BMJ/University of Melbourne, Melbourne, 2013. (5) M. Pearce et al, “Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study,” Institute of Health and Society, Newcastle University, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne, UK, 2012. (6) A. Berrington de Gonzalez, M. Mahesh, K. Kim, M. Bhargavan, R. Lewis, F. Mettler and C. Land, “Projected cancer risks from computed tomographic scans performed in the United States in 2007,” Archives of Internal Medicine, Vol. 169, No. 22, pp. pp. 2071-2077, 2009 (0). Data from: American College of Radiology White Paper on Radiation Dose in Medicine, ACR, 2007. (1). FDA, 2010, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm, (2). Bogdanich, Walt (15 October 2009). "Radiation Overdoses Point Up Dangers of CT Scans".New York Times. (3). Medical observer, 2013, http://www.medicalobserver.com.au/news/french-doctors-jailed-for-radiation-overdoses

7. Concerns has lead to actions?

8. EU is in the forefront when it comes to radiation safety EU Ionizing Radiation Regulations 2000 Regular creation and review of DRL’s • Mandates recording and reporting of Dose Clinical justification of exposures • All exposure justified in its own right by trained staff Training of Operators, Referrers and Justifiers • Minimize exposure given (change referral pattern) • Referral must contain sufficient clinical indication Active investigation and reporting of incidents EU enforcements are currently translated into national laws enhancing regulation further

9. Australia is also in the forefront ARPANSA Defines principals of Justification Optimization • «No practice involving exposures to radiation should be adopted unless it • produces sufficient benefit to the exposed individuals or to society to offset the radiation detriment it causes.» • «diagnostic purposes, including interventional radiology, is: • (i) sufficient to enable the procedure to provide the required information; (ii) not greater than is necessary to provide that information»

10. US is implementing dose regulations California Senate Bill 1237, July 1, 2012 • Requires recording of radiation dose for every CT exam and reporting of events exceeding certain thresholds

11. US is implementing dose regulations Texas Texas Administrative Coderule §289.227, May 1, 2013 • Recording of patient radiation dose on all CT and fluoroscopy exams • Establishment of radiation dose thresholds and patient notification of dose threshold breech • Radiation safety training to all staff members who perform CT and fluoroscopy procedures

12. US is implementing dose regulations Texas More to come? Texas Administrative Coderule §289.227, May 1, 2013 • Recording of patient radiation dose on all CT and fluoroscopy exams • Establishment of radiation dose thresholds and patient notification of dose threshold breech • Radiation safety training to all staff members who perform CT and fluoroscopy procedures

13. Programs & Incentives Examples

14. Programs & Incentives Examples in US • Image gently • Promotes increased awareness in the imaging of children • Image wisely • Lower amount of radiation used in imaging studies for adults • Eliminate unnecessary procedures • Provide resources and information

15. Programs & Incentives Examples in US • JCAHO Sentinel Event Alert #47 • Right test, right dose, effective processes, safe technology, safety culture • Endorse creation of a national registry to track radiation doses • Encourages manufacturers to incorporate dosage safeguards into equipment and to capture dose information in the patient’s electronic medical record

16. Programs & Incentives Examples in US • American College of Radiology (ACR) • National Dose Index Registry (DIR) • Provides feedback reports to compare CT doses against regional and national benchmarks • Currently contains > 5 million CT scans • Over 600 facilities have registered • Registries established in US, UK, Europe

17. What is dosemonitoring?

18. Dose Management Principals 1 Identifyoutliers 2 Comparisons 3 Constantmonitoring 4 Justification 5 Incident investigation 6 Automaticalcollection Basically, automatically collection of dose data utilized throughout the healthcare chain to govern patient safety 8 7 Doseoptimization Robust reporting

19. Dose Monitoring and Reporting touches a broad range of Healthcare Providers • Physicist • Function and safety of equipment • Gathering and reporting on dose data • Monitor trends and identify performance gaps • Referring physician • Improve quality of requests • Justification of orderings • Identify high risk patients Administration Safety Officers Quality Officers • Radiologist • Protocol improvements • Dose optimization • Appropriate justification

20. Whatcan a software vendor like Sectra do?

21. Solution: Dose Tracking Software Automated systems that collect, analyze, and store radiation dose data

22. Solution: Dose Tracking Software SectraDoseTrack • Vendor-neutral PACS and RIS interface allows integration with existing systems. • Supports all imaging modalities, regardless of age. • Provides dosage tracking by patient, technologist, procedure, physician, or facility. • Robust, easy-to-use analytics for auditing purposes. • Powerful reporting capabilities for governmental agencies.

23. SectraDoseTrack design DICOM skickas

24. SectraDoseTrack– In the spotlights • Winner of AuntMinnie.com Best New Radiology Software of 2013 • ACR-certified software partner to the Dose Index Registry. • FDA-registered Class 1 software medical device. • SectraDoseTrack complies with mandated dose reduction, collection, and reporting, including the 2014 JCAHO reporting requirements in the US

25. Joint commission’sregulations on CT

26. Understanding the Joint Commission regulations on CT Radiation Dose – effective 7/1/14 All critical access hospitals that provide diagnostic CT services must: • Document the radiation dose in the patient’s medical record on every study produced during a CT examination. Sectra DoseTrack • Integrates with IDSVoice2Dox, Powerscribe 360 and other dictation software to automatically transfer dose data into the patient report. • Publishes dose data to any EMR/EPR through HL-7 messaging. • Holds a comprehensive patient history of all imaging activity. • Include the dose index or dose-length product radiation dose on the patient’s interpretive report or include on the protocol page. Sectra DoseTrack • Publishes dose data to any EMR/EPR through HL-7 messaging. • Stores and displays dosage calculations from the modality (CTDIvol and DLP) to the patient report. • Generates its own dose report as a separate document/printout, if needed. 1 2

27. Understanding the Joint Commission regulations on CT Radiation Dose – effective 7/1/14 All critical access hospitals that provide diagnostic CT services must: • Establish imaging protocols based on current standards of practice, which address key criteria including clinical indication, contrast administration, age, patient size and body habitus, and the expected radiation dose range. Sectra DoseTrack • Verifies whether standard protocols are being followed while taking age, weight, body mass index, and gender into account. • Provides access to all examination data which allows for proper establishments of dose optimized imaging protocols. • Offers VirtualDoseCT software to calculate pre-imaging and post-acquisition organ dose. • Ensure imaging protocols are reviewed and kept current with input from an interpreting radiologist, medical physicist, and lead imaging technologist to make certain they adhere to current standards of practice and account for changes in CT imaging equipment. Sectra DoseTrack • Allows for monitoring of protocol usage and comparisons between dose levels from different modalities, departments, and hospitals for the same examination code. • Integrates with any PACS to view image-related dose data in order to evaluate protocols and balance image quality with given dose. 3 4

28. Understanding the Joint Commission regulations on CT Radiation Dose – effective 7/1/14 All critical access hospitals that provide diagnostic CT services must: • Compile and analyze data on patient radiation dose and compare it with external benchmarks. Sectra DoseTrack • Is a certified software partner of the American College of Radiology Dose Index Registry. • Sends dose data to any regional or national dose registry via a HL7 feed to compare dose to registry standards. • Creates its own DRL’s (dose reference levels) allowing sites to create and monitor their own thresholds. • Verify and document that all radiologic technologists who perform CT examinations participate in ongoing education that includes annual training on radiation dose techniques, Image Gently, and Image Wisely. Sectra DoseTrack • Tracks and views all radiologic technologists’ performance and operated studies, detailed data can easily be accessed to review their work. • Provides VirtualDoseCT software to help technologists analyze the impact of changing from standard protocols. 5 6