May 3, 2013 1

10201 Wayzata Blvd., Suite 310 Minneapolis, MN 55305 Sales 877.273.1764 www.atirix.com

TJC Sentinel Event Alert 47: Centralized QC in Practice

Steve Backes, CEO

Copyright © 2013 Atirix Medical Systems, Inc. All rights reserved. Atirix® and QC-Track® are registered trademarks of Atirix Medical Systems, Inc. QC-Track is protected by issued and pending patents, including U.S. 8,428,969 “System

and method for tracking medical imaging quality” and continuations

Device Quality Control is needed for imaging systems… • Process to ensure imaging equipment is performing

per manufacturer specifications, regulatory requirements and physicist needs – Quantitative and qualitative tests

– Phantom

– Documentation

• Regulations include:

– Legislation, such as MQSA, California SB 1237 (CT dosing), MN …

– Accreditation, such as ACR

– Advisory, including The Joint Commission, AAPM (e.g. TG142 for therapy centers)

• A well designed QC program is necessary to ensure image quality

May 3, 2013 3

Jordan, S. The Real Thing. Canadian Bottle and Stoneware Collector 20. April, 1997

Oak Ridge Associated Universities (ORAU) Health Physics Historical Instrumentation

Museum Collection.

Action Item 14: “Implement a system for centralized quality and safety performance monitoring…” to include equipment located anywhere in the hospital or clinics, including “radiology department, cardiac catheterization suite, the OR, … physician offices,…”

Action Item 16: “Ensure that recommended quality control, testing (including daily functional tests) and preventive maintenance activities are performed in accordance with manufacturer’s guidelines.”

Sentinel Event Alert 47, “Radiation risks of diagnostic imaging”, 2011

… in response to regulations…

Medicare Improvements for Patients and Providers Act (MIPPA), 2008

Mammography Quality Standards Act, 1994 Sec. 900.12 Quality standards (d)(2) Quality assurance records. The lead interpreting physician, quality control technologist, and medical

physicist shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, protection and employee qualifications to meet assigned quality assurance tasks are properly maintained and updated.

‘‘‘SEC. 135. IMAGING PROVISIONS ‘‘(B) ADVANCED DIAGNOSTIC IMAGING SERVICES DEFINED.—…includes ‘‘(i) diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography); and ‘‘(ii) such other diagnostic imaging services… (excluding X-ray, ultrasound, and fluoroscopy),

(3) CRITERIA FOR ACCREDITATION (E) standards that require the establishment and maintenance of a quality assurance and quality control program by the supplier that is adequate and appropriate to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by such supplier;.

4 May 3, 2013

… and to avoid headlines.

5

West Virginia Hospital Overradiated Brain Scan Patients, Records Show By WALT BOGDANICH

Published: March 5, 2011

THE RADIATION BOOM

After Stroke Scans, Patients Face Serious Health Risks By WALT BOGDANICH

Published: July 31, 2010

THE RADIATION BOOM

X-Rays and Unshielded Infants By WALT BOGDANICH and KRISTINA REBELO

Published: February 27, 2011

THE RADIATION BOOM

As Technology Surges, Radiation Safeguards Lag By WALT BOGDANICH

Published: January 26, 2010

May 3, 2013

Minnesota: Advanced Diagnostic Imaging Accreditation and Reporting Requirements Nov, 2012

“… advanced diagnostic imaging services [CT, MRI, Nuc Med] eligible for reimbursement shall only be reimbursed if the facility where the services has been provided:

1. Has obtained accreditation by August 1, 2013 and

2. Has demonstrated holding accreditation annually in reports to the Commissioner of Health.

May 3, 2013 6

Regardless of motivation, new regulations are being implemented around the country, including here in Minnesota…

Action Item 14: “Implement a system for centralized quality and safety performance monitoring…” to include equipment located anywhere in the hospital or clinics, including “radiology department, cardiac catheterization suite, the OR, … physician offices,…”

Action Item 16: “Ensure that recommended quality control, testing (including daily functional tests) and preventive maintenance activities are performed in accordance with manufacturer’s guidelines.”

Sentinel Event Alert 47 “Radiation risks of diagnostic imaging”

Aug 2011

7 May 3, 2013

… and The Joint Commission has weighed in, too.

How is TJC SEA 47 different? It defines how to implement QC…

May 3, 2013 8

MQSA MIPPA SEA 47

“a QC process is needed for MQSA

accreditation”

“ACR accreditation needed.” “An adequate

QC process”

“Implement a centralized QC system”

“What to do – mammography”

“What to do – CT, MRI, Nuc Med”

“How to implement QC? – Centralized”

… but the reality in most facilities: Binders

9

• QC processes at remote facilities are

difficult to manage

• RSO’s and medical physicists need to travel

to remote facilities to review QC data

• Binders get lost or damaged

• Manual calculations and graphing are time

consuming and error-prone

• Many hours are spent organizing data prior

to an audit

May 3, 2013

ATIRIX SOLUTION: QC-TRACK®

May 3, 2013 10

Device Quality Control

Credentials Management

Web-based device QC and credential tracking system

• Device QC Tracking, Graphing and Trend Reporting

• Automated Phantom Image QC

• Device Failure Tracking

• Apron Tracking

• Credential Tracking

• Device Inventory Listing

• QC Data Repository

• Tablet support

• Designed for intranet operations, with built-in security, audit logging, provisioning and LDAP integration

11

Personal Apron Tracking

May 3, 2013

Atirix QC-Track system

QC-Track has the workflow needed in centralized QC systems...

QC Dashboard

QC Checklist

Worksheet/Templates MQSA

Checklist Device Worksheet

Sign Off

Test Failure Graph

QC-Connector™

12

QC-Track.Aprons

Reports

Trend Analysis

Apron Tracking

Batch Reporting

Custom Reporting

May 3, 2013

Credential Dashboard

Facility/Room Credential

Worksheet/Template

Professional Credential

Worksheet/Templat

e Professional License/

Certificates

ACR Accreditation/ Physicist Survey

… and the credential workflow for a complete QC tracking program

13 May 3, 2013

Credential reports by Modality

The QC Dashboard reveals QC status at-a-glance…

14

… providing links to worksheets, graphs and reports May 3, 2013

Built-in alerts if a test fails

QC-Track Worksheets are based on the vendor’s QC Manual, ACR guidelines, and medical physicist needs

!

Technologist records the QC results on a worksheet

Each test has its own worksheet • Calculations with thresholds

• Pass/Fail

• Customizable

QC-Track performs the calculations

QC-Track verifies results and notifies if test fails with yield icon

Facility can modify worksheets using Worksheet Editor for special needs of inspectors or medical physicists

15 May 3, 2013

And Atirix provides many Worksheets “off the shelf”

16

CT ACR Phantom QC Daily & Weekly Worksheets

MAMMOGRAPHY Fuji CR GE Senographe DS/Essential Hologic M-IV, Selenia Dimensions 2D/Dimensions 3D (Tomo), Selenia/ Selenia Tungsten Siemens Mammomat Novation DR

MRI ACR Phantom QC Daily & Weekly Worksheets

CR/DR/FLUORO SYSTEMS DISC Plus, IBA Primus, PTW Normi Phantom QC

Daily & Weekly Worksheets

STEREOTACTIC BIOPSY SYSTEMS ACR Stereotactic QC GE Upright Hologic MultiCare Platinum

LASER PRINTERS AGFA Drystar AXYS/ 4500M/5500/5300/5503 Fuji DryPix 4000/5000/7000 Kodak 5850/6800/6850/8900 Konica DryPro 793/873 Sony UP-DF750

DIAGNOSTIC REVIEW WORKSTATIONS AGFA Impax Barco Coronis MFGD5421/MFGD 5621 HC Eizo Nanao G5521 Hologic SecurView Kodak Carestream Mammography Planar Dome C5i E5 Siemens Syngo MammoReport Tokoku ME25

DIGITIZERS Hologic – R2 DX/LS Vidar R2 Image Checker - Vidar

DEPARTMENTAL - Mammography Operations Reject Analysis (Multiple imaging unit)

May 3, 2013

… clean, professional graphs and reports,…

17

QC-Track meets accreditation reporting needs • Generate device QC reports

• Modalities • Accessories, including printers, review

workstations, digitizers, etc.

• Generate weekly, monthly, quarterly, annual reports and graphs on demand

• Enables access from report summaries down to detailed worksheets via built-in drill-down capability

Batch Reports

• Full audit packages can be generated at any time

MQSA Reports

Checklist Device Worksheet

Sign Off

Test Failure Graph

May 3, 2013

… as well as Custom Trend Reporting, for analysis not possible in a paper-based “binder” system.

18

• Compare data elements and identify trends • Multiple values within a device • Multiple devices within a facility • Devices across facilities

• Customize the report

• Name • Visual indicators • Time frame

• Save the report • Re-run the same report

• PDF or print

May 3, 2013

QC-Track also has built-in QC Review and Sign-off, for Interested Parties

19

• Interested Parties - lead interpreting radiologist, medical physicist, lead QC technologist and facility management - are able to review and sign off electronically

• See FDA website article posted Feb. 2010

• QC-Track includes a report that shows the sign-off status for each of the devices in a facility

• Interested Party utilizes QC-Track to review QC status to their satisfaction

• QC-Track reminds Interested Party that sign-off is due

May 3, 2013

Professional and Facility Credentials

20

• Dashboards for clinical professionals and facility tracking include credentials and their status

• Track and manage • Credits/CEUs

• Exams

• Related documents

• Identify at-a-glance pending or past-due requirements or renewals

• Emails sent when credits coming due

• Links to detailed views of uploaded physicist reports, scanned certificates, and documents

• Generate reports per ACR requirements for each modality

May 3, 2013

…so, with all that, which regulations to follow?

Analog and FFDM quality control

MQSA MIPPA / ACR Accreditation

Joint Commission SEA47

Mammo professional and facility credentials Medical audit/patient letters

QC sign-offs

CT quality control MRI quality control

Breast MRI quality control

Professional credentials

Centralized QC system (Action Item 14) Follow vendor’s QC process (Action Item 16)

Procedure documentation

Annual 18 – 36 month On-site Audit schedule Random

State/AAPM/ Medical Physicist

As needed

As needed

As needed

21

Fluoro/CR/DR/other

varies

Device Inventory listing

May 3, 2013

SEA 47 IN PRACTICE: UNIVERSITY OF VIRGINIA

May 3, 2013 22

University of Virginia Charlottesville, VA

• 578 bed academic hospital

– 12 affiliated locations

• 150+ imaging units (CT, MRI, FFDM, US…)

• 3 full time medical physicists

May 3, 2013 23

UVA Site 2

QC Data

UVA Site 1

UVA Situation in 2010 • Seeking automated solution to support vision for

QC as a key component of overall image quality

• Limited QC automation: RIT Radia for CT, MRI

– Limited integration where QC automated…

• “System silos”, “Data silos”

• Complex MQSA QC

– 7 FFDMs across 4 locations

– Multiple vendors and generations of FFDM systems

• Explored cost of building in-house QC system…

May 3, 2013 24

QC Data

UVA installs QC-Track

May 3, 2013 25

1. FFDM

2. CT, with Radia & QC-Connector

(XML)

3. Apron Pilot

4. Aprons

5. CT with Radia.Net

(embedded)

6. MRI with Radia.Net

(embedded)

2012 2013

RSNA 2011 “Can you add apron tracking to the QC-Track system?”

Allen Goode, Lead Medical Physicist

26

QC workflow with QC-Track

1. Dashboard indicates QC tests are due in a department

2. QC data gathering. FFDM console reviewed, phantom is scanned, or aprons are gathered and worksheets are completed

3. Results are matched to devices and tests, comments added, and data is entered into QC-Track. Failures are recorded and tracked.

4. QC data available for tracking, reporting

May 3, 2013

Situation today…

27

• Full digital QC for 2 modalities • 7 FFDMs in 4 locations • 5 CTs in 2 locations

• Apron tracking

• 2,500+ aprons in 35 locations

• 85+ users trained in 35+ locations

Result: Interested Parties now have centralized system to track status across locations

May 3, 2013

35+ UVA Sites

QC Data

UVA Intranet

Metrics – as of April 25, 2013 • 11,974 worksheets recorded • 1,192 weekly CT Phantom “uploads” • 997 reports have been run, including 12

batch reports

May 3, 2013 28

Test Count Test Count

Aprons Protective Shielding 1,851 FFDM Viewbox and Viewing Condition 596

Flat Field Test 453

Workstations Phantom Image - DRW 593 Weekly Checklist 226

Quality Control Check 391 SNR/CNR 200

Phantom Image Quality and CNR - AWS 387 Detector Flat-Field Calibration 199

Artifact Evaluation - AWS 198 Compression Thickness Indicator 191

DRW - Phantom Image - 2D 49 Visual Checklist 160

Phantom Image 139

Monitors Monitor Cleaning 1,575 AOP and SNR Check 88

LCD Calibration 64 Phantom Image Quality - AWS 71

Phantom Images 69

Biopsy systems Localization Accuracy - Lateral Approach 332 CNR and MTF Measurement 68

Localization Accuracy - Vertical Approach 331 MTF Measurement 67

Needle Path Block Test 331 Empty Reject Bin 60

Repeat Analysis (<=20%) - Digital 6 Phantom Image - 2D 60

Compression 3 Phantom Image - Tomo 58

Repeat Analysis Check 33

Printers Laser Imager Quality Control 700 Compression Force 27

Artifact Evaluation - Printer 278 Repeat Reject Analysis 24

DICOM Printer Quality Control 278 Repeat Analysis 23

Geometry Calibration 4

Failures: “Better visibility than ever before”

• 288 logged in 2 years

• All failures logged in Failure Log

• Types of failures – Actual “failures”

» Printers » Visual checklist

– “Technical failures but acceptable”

» Known CT phantom ROI positioning issue vs. spiral CT

– Training issues…

May 3, 2013 29

So, what have we learned? • Gaining the commitment needed for an enterprise QC system is a complex

advocacy process for the physics team

– Radiology director – funding

– Department managers – implementation, on-going use

• Aprons – 35 departments….

• Early visible success in FFDM helped build acceptance

• Lots of aprons de-commissioned when faced with tracking “seldom used” pieces

• Flexibility of QC-Track model helpful in meeting federal and state-specific regulations

May 3, 2013 30

… and an obvious lesson: “Enterprise” = “Lots of parties”

May 3, 2013 31

Centralized QC System

Imaging Vendors

IT

Regulators Inspectors

Medical Physicists

Systems (Atirix QC-Track®)

Technologists RSO

Radiology Management

… a few other observations…

• Sponsorship, particularly with recommended span of SEA 47

– E.g., at UVA the physics team manages only the ionizing radiation systems

• Atirix needs QC-Track automated modules for more modalities, esp. Nuc Med

• SEA 47 -- “guideline” versus “enforced”… versus experience of MQSA: MQSA resulted in improved image quality – Spelic. FDA Report 2003.

– Pisano et al. AJR: 174, April 2000.

– Suleiman,OH et al. Radiology 1999; 210: 345-351.

May 3, 2013 32

…and the good news: a well designed digital QC program can also have a positive financial impact.

• Improved Productivity – Reduced travel, documentation expenses

– Reduced QC time, increasing imaging unit availability

– Process consistency

• Increased information availability – Inspections, prep and on-site response time

– Failures and other service events

• Improved Reimbursement – Government payers

• MIPPA requires accreditation (ACR, The Joint Commission, IACTL) for Medicare reimbursement

– Private payers

• United Health, other insurers require ACR accredited imaging units

May 3, 2013 33

- Questions - Upcoming conferences: AHRA - Thanks to University of Virginia Radiological Imaging Technologies (RIT)

- For more information

May 3, 2013 34

Steven J. Backes President/CEO

Moving Medical Decisions

Atirix Medical Systems, Inc. 10201 Wayzata Boulevard Minneapolis, MN 55305 952.674.4726 office 952.546.2023 fax 612.723.5268 cell

www.atirix.com

Sales 877.273.1764 www.atirix.com

Copyright © 2013 Atirix Medical Systems, Inc. All rights reserved. Atirix® and QC-Track® are registered trademarks of Atirix Medical Systems, Inc. QC-Track is protected by issued and pending patents, including U.S. 8,428,969 “System

and method for tracking medical imaging quality” and continuations