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The Legal and Regulatory Impact of Digital Mammography Presented by Bonnie Rush, RT(R)(M)(QM) President, BIS – Breast Imaging Specialists Consulting, Education.

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Presentation on theme: "The Legal and Regulatory Impact of Digital Mammography Presented by Bonnie Rush, RT(R)(M)(QM) President, BIS – Breast Imaging Specialists Consulting, Education."— Presentation transcript:

1 The Legal and Regulatory Impact of Digital Mammography Presented by Bonnie Rush, RT(R)(M)(QM) President, BIS – Breast Imaging Specialists Consulting, Education and Community Outreach Author, MQSA Made Easy phone/fax Monday, July 9,2007 2:30 – 4 PM

2 Co-sponsored by Beekley Corporation Radiology Skin Markers Breast Biopsy Accessories & Iron Mountain Records Management Company

3 The Impact of Digital Mammography Mammography Is A Challenging Modality Tight Balancing Act Between Requirements and Limitations

4 Why Transition At All? Analog Has A Low PPV Misses 10-15% of cancers overall Misses 20-35% of cancers in dense breasts Digital Mammography Has Many Advantages

5 Has Analog Reached Its Peak Capabilities? Fatty Tissue and Masses Glandular Tissue and Microcalcifications

6 Film Characteristics – Tied to H&D Curve Densities are displayed in the toe of the curve = low contrast and inability to delineate characteristics adequately

7 The Challenge Fibrous (dense) tissue and infiltrating ductal carcinoma have almost the same attenuation making it difficult to see the pathology!

8 Advantages of Digital Mammography Ability to manipulate images Not tied to H&D curve Increase in perception of changes Reduces recall rates Telemammography is available Reorganization possibility Experts can be utilized Soft copy is always an original No lost images Simple interface available to run CAD

9 The Digital Mammographic Imaging Screening Trial – DMIST ( women) Does this impact the timing of our transition to digital?

10 The DMIST indicated 65% of women would benefit from digital.

11 Who Are These Women? Under 50 Pre- or peri-menopausal Heterogeneously or extremely dense breasts

12 More Importantly Cancers detected by digital … and missed by film in the subset, included many invasive and high grade in situ malignancies. These are precisely the lesions that must be detected early to save more lives through screening. »Digital vs. Film Mammography in the Digital Mammographic Screening Trial (DMIST): Questions and Answers

13 Maintaining Patient Base In Analog "Fast Facts" Etta Pisano, Co-Principal Investigator, ACRIN DMIST

14 Film mammography has been successfully used as a screening tool for breast cancer for over 35 years. It would be better to have a film mammogram …than for her to delay her screening in order to get a digital mammogram. No woman should defer screening with mammography just because of a lack of access to digital mammography.

15 A Consideration For the Analog Department The identified improvement in accuracy is important to consider when providing services to this subset… especially if there are digital units they could be referred to. Could be seen as a reason for delay in diagnosis if analog does not find the cancers that are detected later.

16 Diagnostic Findings RCC - Digital Image RCC- Screen Film Image Hologic

17 FFDM Stats FFDM's market share rose from 3% in 2003 to 13.8% in 2006, –report from market research and consulting firm, Frost & Sullivan of San Jose, CA ("North American X-Ray Mammography Markets," February 6, 2007). FDA stats 7/1/07 –Total certified facilities / 8,836 w/FFDM units / 1,991 = 22.5% –Total accredited units / 13,405 FFDM units / 2,926 = 21.8%

18 Living in The Digital Divide Offering Both Digital and Analog Patient Issues Legal Issues Productivity Issues

19 Choosing the Digital Divide Some entities believes that it makes sense to start out with one digital unit, identify problems that might arise, and then develop solutions before acquiring additional systems. Others cannot afford to transition all at one time. How will you triage your patients?

20 Offer Every Women a Choice? ~ Tried offering digital mammography on a first-come, first-served basis. As increasing numbers …are starting to ask for digital mammograms, the staff now tries to accommodate those requests. The plan is to perform annual and follow-ups on the digital unit if a patient's prior studies were done digitally. Zeeshan Shah, MD, and other physicians at the Indiana University School of Medicine - Understanding Workflow in the FFDM Environment By Carol Daus Decisions in Imaging Economics October 2004 Before DMIST results but… this was still not efficient!

21 Pre-screen Every Patient? ~2003 … the radiologists look at the previous year's films to see which women would benefit from digital imaging. "If we have three patients coming in per hour, it is not hard to determine which one is better suited to the digital unit," Laurie Fajardo, MD, chair of the department of radiology, University of Iowa Health Care, Iowa City. Understanding Workflow in the FFDM Environment By Carol Daus Decisions in Imaging Economics October 2004 But you need about 6 per hour to support digital!

22 Educate Those That Fall Outside The DMIST Profile? For these women, –Over age 50 –are no longer menstruating and –do not have dense or heterogeneously (very dense) breast tissue –there was not a statistically significant difference between the sensitivity of digital vs. film mammography. Must review old films for tissue density

23 Negatives Time consuming to pre-screen and/or educate Legal risk if cancer found next year on digital and had analog this year Technologists and radiologists living in analog/digital divide decreases overall productivity.

24 Analog or Digital Positioning and Interpretation Brenner 2003 Probably the two most important factors to reconcile whether digital or film is better, have to do simply with who interpreted the study and what they decided on management, and on positioning differences. Dershaw 2005 The experience and skill of the technologist performing the exam and the expertise of the radiologist who evaluates it are at least as crucial as whether the mammogram is done digitally or with traditional film.

25 MQSA FFDM Guidance DR and CR

26 What Units Are Approved/Available Direct Radiography (DR) GE Senographe 2000D GE Senographe DS GE Senographe Essentials Hologic/Lorad Selenia FFDM System Siemens Mammomat Novation DR Computed Radiography (CR) Fuji Computed Radiography Mammography (FCRm)

27 Accreditation and Certification How Do They Differ? Only MQSA certified facilities can lawfully provide mammography services. Issuance of an MQSA certificate occurs AFTER the Accrediting Body (AB) notifies the Certifying Agency (CA) that the facilitys accreditation application is acceptable.

28 Accreditation The AB will accredit the facility once it establishes that the mammography facility meets the quality standards established under MQSA.21 C.F.R The regulations require the AB to review a mammography facility's equipment, personnel (interpreting physicians, radiologic technologists, and medical physicists), and practices including a review of clinical images and phantom and dose.

29 The Accreditation Process Medical Equipment Evaluation (MEE) by Medical Physicist (MP) Send in to AB w/application and accreditation fees AB notifies the CA w/in two business days of acceptance of application Facility receives 6 month certificate.

30 New To Mammography Because your facility is not already certified, you MUST receive your MQSA certificate before you begin patient exams Check with your state in case they mandate applications before beginning patients

31 Certified - Adding New Unit CMS will not reimburse for examinations performed until the CA is notified by the AB they received your application materials Wait 3 business days – contact AB Confirm CA received info Begin patient exams

32 Accreditation packet arrives Submit hard copy clinical and phantom images and TLD (dosimeter) w/in 45 days Wait and pray for about 60 days!!! If pass receive 3 year accreditation and certification And Then…. The Hard Part Begins

33 Submission Considerations

34 Positioning Training Is Essential … receptors as thick as 3.5 inches at the chest wall. … "dead space" between... receptor edge (at) …chest wall and where the actual image is captured. …may make it difficult for some technologists to obtain as much tissue …as they were able to obtain with analog. –Examine Mammography: A True Transition Becoming proficient in a digital world vol. 20, RT Image no March 26, 2007 By Tammy Coryell, RT(R)(M)

35 RMLO - Screen Film Image RMLO - Digital Image Nowhere to Hide!

36 Screen-Film and Digital Comparison LCC - Screen Film Image LCC - Digital Image Hologic

37 Who Does It? Accrediting Bodies (AB) ACR, Arkansas, Iowa and Texas Your facility may accredit with the ACR or the State Certifying Agencies (CA) FDA Illinois, Iowa and South Carolina Your facility must use the state CA Their requirements are the same as the FDAs

38 AB Contact Information American College of Radiology (ACR) Mammography Accreditation Program Mammography Accreditation Program Arkansas Department of Health and Human Services Division of Health Radiation Section Mammography Program Mammography Program Iowa Department of Public Health Bureau of Radiological Health Mammography Program Mammography Program Texas Department of State Health Services Radiation Control Program Radiation Control Program

39 ABs and Units They Approve As of February 21, 2007 Accreditation Body Effective Date FFDM Unit ACRArkansasIowaTexas GE Senographe 2000D 02/15/0308/15/0610/01/0305/21/04 Fischer Imaging SenoScan 08/15/03 05/21/04 Lorad/Hologic Selenia 09/15/0308/15/0610/01/0305/21/04 GE Senographe DS 09/15/0408/15/0601/17/0609/15/04 Siemens Mammomat Novation 10/15/05 02/01/0606/29/06 GE Senographe Essential 07/15/0608/15/0608/24/0609/05/06 Fuji Computed Radiography for Mammography 11/15/0610/12/0611/13/06

40 CA Contact Information MQSA Facility hotline at or by to State of Illinois - Office of Radiation Safety - MAP Department of Nuclear Safety 1035 Outer Park Drive Springfield, IL Iowa Department of Public Health Lucas State Office Bldg., 5th Floor 321 East 12th Street Des Moines, Iowa State of South Carolina Mammography Certification Program Department of Health and Environmental Control 2600 Bull Street Columbia, SC

41 CR Accreditation and Certification Specific to The Mammography Unit If you have multiple S-F units and plan to use CR with more than one, must submit for each unit you will use even if they are the same make and model

42 Medical Physicist Involvement Initial Survey at Installation - MEE Annual Surveys Software Upgrades

43 Medical Physicist MEE 900.2(bb) Mammography equipment evaluation (MEE) means an onsite assessment of mammography unit or image processor performance by a medical physicist for the purpose of making a preliminary determination as to whether the equipment meets all of the applicable standards in section (b) and (e).

44 QC is Manufacturer Specific

45 Physicist Training Medical physicists who have met the new modality training requirement (8 hours) should also receive training in any new unique features before beginning to perform evaluations of other units Document their FFDM training for your equipment (DR v. CR surveys - differing manufacturers tests and testing procedures and updates - software changes)

46 Medical Physicist's Equipment Evaluation and Annual Survey Forms and Approved Alternative Requirements For Each Manufacturer Available at - link to the Accreditation Mammography Forms Med Phys Equip and Ann Survey Forms

47 Annual Surveys At least once each year (up to 14 months between). Signed by the qualified MP that performed or supervised the survey. As of July 1, 2007 annual surveys no longer need to be sent to the AB each year

48 Software Changes/Upgrades Considered Major Repairs Approved software changes relates mainly to GE FFDM Units The manufacturer will specify the tests and who must perform them: –Some must be performed by the MP or under the direct supervision of the MP –Some can be performed by the QC technologist under MP oversight Oversight = MP is consulted as to whether an on-site visit is required or if other personnel can verify that the standards are met, with direction by telephone or printed material from the medical physicist as needed. The tests must be adequate for determining whether all standards are still met.

49 Equipment Evaluations/Repairs Listed in the MQSA Policy Guidance Help System (PGHS) Listed in the manual MQSA Made Easy Exhibit 6: Medical Physicist Involvement in Equipment Repairs Equipment evaluation of a unit or processor that has been disassembled and reassembled All applicable tests and equipment requirements described in (b) and (e) Alternately the decision can be made by the medical physicist. Equipment evaluation of a unit or processor that has undergone a major repair Only those tests and equipment requirements described in (b) and (e) that are applicable to the repaired component of the unit or processor. The decision as to what constitutes applicable tests and equipment requirements for the repaired component should be made by the medical physicist.

50 Personnel Requirements Initial Modality Specific Training Continuing Education

51 Initial Modality Specific Training All involved personnel must have at least 8 hours of training Personnel who use FFDM prior to January 1, 2006 will be considered to have met the 8 hour requirement. Such personnel can attest to or document this experience. CR or DR - they should receive training on component differences prior to using the unit clinically

52 Acceptable Training Documentation Modality specific CME/CEU courses plus agenda, outline, or syllabus Confirming letters from CME/CEU provider Letters, certificates or other documents from manufacturers or other formal training providers

53 Modality Specific Continuing Education The FDA is to delete this requirement and will delay enforcement indefinitely due to recommendations from the National Mammography Quality Assurance Advisory Committee (NMQAAC) and the Institute of Medicine (IOM).

54 Recordkeeping Retention Transfer

55 FFDM Guidance There are two sections of the recordkeeping requirement that are affected by the introduction of FFDM –The first deals with retention of the mammography images and in what format –The second deals with transferring of images.

56 What Constitutes a Mammogram For Image Retention Purposes? For digital imaging, –the facility must maintain, in retrievable form, for the required retention timeframes either the Original (raw) lossless compressed data or hard copy films that duplicate the soft copy interpretive quality

57 Identification Mandate The regulations require identifying information be indicated on each mammographic image, as with hard copy film.

58 Lossless v. Lossy Image Compression Lossless compression accurately preserves all the essential data from the original image and is mandated for mammography. –Reduces file size by compressing only the non- essential area surrounding the actual breast image. Lossy compression does not preserve all the essential data and is acceptable for most imaging modalities –It averages a group of pixels to compress the image

59 Lossy Compressed Images From a risk-management perspective, it's going to be extraordinarily difficult to defend a "failure to diagnose" case involving lossy- compressed images. Plaintiffs' attorneys are getting increasingly sophisticated with regards to these issues, and they will press this point. –Spencer Studwell, a senior associate general counsel, director of risk management, University of Rochester Medical Center Vigilance key to managing risk in the digital world 5/15/2007 AuntMinnie By: Erik L. RidleyErik L. Ridley

60 Electronic Image Transfer Facilities may transfer, when it is acceptable to the recipient, such as a transfer between two FFDM facilities, the original or lossless compressed images electronically.

61 Comparison With Outside Digital Images There simply is not the ability to conveniently exhibit comparison digital images from different types of units

62 Cautionary Advice Faithful reproduction of the processed image may be subject to modest acceptable variations; –even current practices that compare images from other institutions will identify differences in technique and accommodate for such differences. The user is advised to validate such transmission, …so that significant image differences do not invite misinterpretation. –Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner MD,JD,FACR

63 Were Getting There Integrating the Health Enterprise (IHE) mammography subcommittee has been working with vendors to specify what needs to be done to ensure consistent display of images.

64 Integrating the Health Enterprise

65 IHE Mammo The Mammography Image Integration Profile (MAMMO) specifies how DICOM Mammography images and evidence objects are created, exchanged and used. It is currently published in a Trial Implementation draft, which will be used for testing at Connectathons in 2007.

66 Hard Copy Image Transfer For purposes of transferring images, –Upon request the facility must be able to provide the medical institution, physician, healthcare provider, patient or patients representative, with hard copy films of primary interpretation quality. In order to conform to this requirement, all facilities need access to a printer.

67 Charging for Hardcopies The facility may not charge for creating the first hardcopy version of the mammogram. –However, if the patient requests a second one or more additional hard copies of the mammogram, the facility may pass the costs of that reproduction on to the patient.

68 Printers and Monitors Printer Requirements Monitor Requirements

69 Requirements for FFDM Printers Printers no longer have to cleared by the FDA But they must be able pass all applicable QC tests established by the FFDM manufacturer Must pass the facilitys accreditation bodys phantom and clinical image review process. QC must be performed at their appropriate frequencies or, prior to printing clinical images for patients and other health-care providers.

70 Printers - Dry Laser of Course Image quality depends on a number of factors including –resolution, noise, image color, interpolation and overall contrast and density Requirements are greater than any other imaging need: –A Dmax of 3.5 or greater –A base plus-fog level of less than –16 bit images with at least 12 bit gray levels. –Image color blue/black like analog

71 IHE Considerations Print composers should support true-size printing, –since this ensures accurate measurements on printed film. Images should be justified so that the chest wall is printed as close to the edge of the film as the print server is capable of printing it. All annotations defined for image displays, along with a ruler or distance scale, should be burned into the pixel data. A pixel transmission of 12 bits or more to the print server should be specified. »Digital Mammography: Integration Into a Practice by Laurie L. Fajardo, MD, MBA; and Jeong Mi Park, MD Imaging Economics December 2006

72 Monitors Review Workstations (RWS) The Portal to Filmless Mammography LORAD RWS

73 FDA Mandates 5K Monitors to achieve the resolution needed in mammography Multi-Modality Makes Sense Multi-Modality Breast Image Review Station Synapse®, Fujis web-based PACS

74 IHE Directives The radiologists can specify image hanging protocols –that fit their reading preferences The image hanging protocols allow –the combination of current and prior studies Appearance of the images –is accurate in the displayed gray levels Application of window level/width is smooth –And does not suddenly wash out the displayed information Changing the window level/width –does not change the background of the image Study information is displayed as on analog images The RWS is able to display CAD marks –on top of the corresponding images.

75 Monitors - QA Differences QA can be a substantial time commitment –Be informed about the manufacturer's recommended QA program and understand the amount of time required to perform all QA tasks associated with the display. …automated display calibration solutions are helping to decrease this burden. Automated Display QA Delivers Peace of Mind... and More Health Imaging & IT June 1, 2006

76 QC Criteria CR v. DR Records Retention Timeframes

77 QC Testing (e)(6): For systems with image receptor modalities other than screen- film, the QA program shall be substantially the same as the QA program recommended by the image receptor manufacturer, –except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.

78 Quality Control DR or CR Each manufacturers manual will explain their required QC procedures By regulation, facilities must follow these manuals (in terms of the frequency of the QC tests as well as the QC test procedures) when performing their routine QC tests, mammography equipment evaluations (MEE), and annual physics surveys.

79 Initially QC will take longer until the QC technologist is familiar with the tasks S-F 11 tests – FFDM 15 (depends on manufacturer and modality approach) Elimination of wet processing immediately reduces many of the daily QC concerns There is the potential that eventually many of these tasks will becoming automated i.e. Repeat Analysis: Repeats are immediately entered and can be downloaded by category/individual.

80 Phantom Testing For Weekly QC Record/Images: Lorad/Hologic Selenia Siemens Mammomat NovationDR, Phantom test passing score is 5, 4, 4 (or 4.5, 4, 3.5 under certain conditions). For the phantom produced during the inspection for regulatory action: Passing score is the same as was established by the FDA approved accreditation bodies for S-F systems - 4, 3, 3 Some manufacturers (like GE and Lorad/Hologic) also instruct the facility to conduct and pass the flat field test before conducting the phantom image test.

81 LoRad Daily and Weekly Tests Sample from ACR website Highlighted tests are specific to FFDM systems Darkroom Cleanliness (daily, if app) Processor QC (daily, if app) Laser Printer QC (weekly-dry; daily-wet) Viewboxes and Viewing Conditions (weekly, if app) Artifact Evaluation (weekly) SNR & CNR Measurements (weekly) Phantom Image (weekly) Detector Flat-Field Calibration (biweekly) Review Workstation QC (See FDA Guidance)

82 LoRad Monthly, Quarterly & Semi-Annual Tests Sample from ACR website Highlighted tests are specific to FFDM systems Visual Checklist (monthly) Analysis of Fixer Retention in Film (quarterly) Repeat Analysis (quarterly) Darkroom Fog (0.05) (semiannually) Compression (25-45 lb) (semiannually) Review Workstation QC (See FDA guidance)

83 Remain Updated Because of continuing innovations in digital mammography and software programs, FFDM system manufacturers typically issue updates or revisions of their QC manuals to keep them current. The facility must have on hand the most recent QC manual and follow these testing procedures.

84 List of Mandated Tests and QC forms and FDA Approved Alternative Requirements For Each Manufacturer Listed on ACR website – Link to the following Accreditation Mammography Forms RT QC Forms

85 Correction Period for FFDM Failures If related to the image review components only, –images can continue to be acquired. If related to the acquisition of images only, –the review of already acquired images can continue For FFDM specific component corrective action timeframes refer to the FDA website for approved alternatives – – or check with the unit manufacturer.

86 QC Test Retention Timeframes Daily QC tests Previous 30 days Weekly QC tests Previous 12 weeks Monthly and Quarterly QC Tests Since the last inspection Semi-Annual QC Tests Since the last inspection and/or until the test has been performed two additional times at the required frequency, whichever is longer

87 QC Tests - Record Retention Keep records and all applicable corrective actions for the longer of the below: –The last 12 months –since the last annual inspection which verifies compliance –until the test has been carried out an additional two times at the required frequency.

88 Inspections Dr and CR All inspection tests similar to S-F will be performed by the inspector

89 Inspector Will Check MEE or survey performed by the MP Personnel Training Documents Latest version of all QC manuals for system components issued to it by the manufacturer Conducted all the QC tests listed in the manuals Performed monitor and printer QC per manufacturers recommendations Performed (and documented) timely corrective action(s) for the tests that failed.

90 The Inspection Phantom Test The QC technologist will expose the facilitys phantom with the technique factors used clinically for the weekly phantom test Displayed/scored on the AWS or the RWS depending on the FFDM unit Displayed with the window level/width to the facility uses to review and score its phantom images.

91 Legal Considerations "It takes a while for the legal system to catch up with medical technology. The law hasn't caught up with digital radiology yet, but eventually it will." Leonard Berlin, MD, Radiology Chair, Rush North Shore Medical Center Digital Images Meet the Law by Lisa Fratt September 2004 HEALTHIMAGING.COM

92 Reasonable Clinical Practice Patterns The potential legal issues derivative (offshoot) to such technology should be recognized so that reasonable clinical practice patterns may integrate such considerations into their approach. »Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

93 Importance of QC Should Not Be Underestimated The lack of uniformity of QC standards …... invites a wider consideration of the medical legal implications related to FFDM. If a cancer is later detected on a different type (CR or DR) or FFDM unit (or with a different workstation), compliance with a vendor defined QC program will likely survive objections. Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

94 Interpretation Issues Image Manipulation An electronic image can be changed in a number of ways. Now, were introducing a whole new litany of potential allegations stemming from a radiologists failure to manipulate a digital image properly. Leonard Berlin, MD, chairman of radiology at Rush North Shore Medical Center (Skokie, Ill.), September 2004 HEALTHIMAGING.COM Digital Images Meet the Law by Lisa Fratt

95 Room Lighting Studies at the Baltimore VA Match ambient room light to monitor light in a reading room, Radiologists window/level images half as often as when light isnt balanced Complaints of fatigue drop to zero from 50 percent. Dream Reading Rooms Require Team Effort Health Imaging & IT - April 1, By Cheryl Hall Harris, RN

96 Radiology Reading Room of The Future Leslie Fort, MD, sits in the Radiology Reading Room of the Future at the Baltimore VA Medical Center that has Xybix furniture, chair and ergonomic technology solutions and a GE Centricity PACS workstation. Reading Room Essentials Health Imaging & IT December 1, 2006

97 The Subject Of Current Investigation Reasonable manipulation: … may require an understanding of limitations for certain types of lesions and thus greater image manipulation. Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

98 Importance of the Audit But…prolonged and extensive windowing might not be routinely justified, –especially if audit-demonstrated outcome data from standard manipulations yield results consistent with reasonable practice. »Full Field Digital Mammography: Initial Medical Legal Concerns – R. James Brenner, MD,JD,FACR

99 The Effective Audit The ACR web site – step-by-step educational guides for understanding and initiating a standard breast imaging audit.

100 Benchmarking Benchmarking between like entities is important but ….difficult at best. –The National Consortium of Breast Centers (NCBC) ( is recruiting member centers to join their –Emphasis is placed on ability to compare with same type of facilities.

101 Magnification Considerations Geometric v. Electronic

102 Electronic Magnification By distributing the imaged data over more pixels, an apparent increase in resolution is anticipated. However, clinical trials are lacking to validate this hypothesis. Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

103 Legal Concerns Some users have employed electronic magnification for the diagnostic analysis of a specific focus. Where standard of care concerns would prompt (geometric) magnification views, this approach may be contested. »Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

104 Electronic Magnification Benefit 2005 Study Assessment of BI-RADS 4 or 5 –Magnification recalls for microcalcifications 56.5% of SFM patients 8.8% of FFDM patients In 91.2% of FFDM patients, recommendations for biopsy of suspicious microcalcifications were made without recall. »Investigator Dr. Nancy Wilson, a staff radiologist at Sarasota Memorial Hospital, Sarasota, Florida

105 Comparison Issues Hard Copy Priors Lossy v. Lossless Compression Digitizing Considerations White Paper Available at Iron Mountain Taking Your Imaging Environment Totally Filmless and Fully Compliant

106 * All exams were timed from patient arrival in the exam room through patient release. ** Indicated time includes the time for data entry, technologists explanation of the overall exam procedure to the patients, in addition to the above imaging chain. *** The size (or %) of the reduction proven by the assessment may vary from institution to institution. DR = 45% Reduction average examination time DR - Exam Using Digital Imaging 8.4 min* Patient in Room First Exposure & QC Last Exposure & QC Release Patient/ Send Study to RWS 0.43% Repeat Rate SFM - Conventional Imaging Exam With Film 15.9 min* First Film Out of Processor Patient in Room First Exposure Last Exposure Last Film Out of Processor Release Patient 2.30% Repeat Rate QC DR v. Analog Exam Time Courtesy GE Medical Systems

107 Analog to Digital Interpretation Times 1.4 min for analog and 2.3 for digital Average time for interpreting film-screen (light gray) and digital (dark gray) mammograms for each physician. Rad = radiologist. Berns EA, Hendrick RE, Solari M, Barke L, Reddy D, Wolfman J, Segal L, DeLeon P, Benjamin S, and Willis L, "Digital and Screen-Film Mammography: Comparison of Image Acquisition and Interpretation Times" AJR 2006; 187:38-41).

108 Value of Comparison Films AJR 2005 Study: Importance of Comparison of Current & Prior Mammograms in Breast Cancer Screening Without priors, more annotations made More patients would be recalled for additional imaging Reading performance significantly better when priors available 12 experienced radiologists 160 soft-copy mammos 80 negative/benign 80 cancers confirmed Read twice (with & without priors) Results Conclusion Comparison with priors significantly improves overall performance and can decrease non-lesion work-ups by up to 44% Study Format

109 Prior Studies Persistent themes from recent malpractice claims in which the court decided in favor of the plaintiff include a failure to consult a prior study or report…, –Spencer Studwell, senior associate general counsel, director of risk management, University of Rochester Medical Center AuntMinnie - Vigilance key to managing risk in the digital world 5/15/2007By: Erik L. RidleyErik L. Ridley

110 Comparing Hard Copy Priors … digital and analog images look so different, –a digital image is almost twice the size of a film image,… –…contrast can be so different …, it's sometimes difficult to tell if a certain cluster of calcification was really there on the prior film." Zeeshan Shah, MD, and other physicians at the Indiana University School of Medicine Understanding Workflow in the FFDM Environment By Carol Daus Decisions in Imaging Economics October 2004

111 IHE – Digitization Expediting The Transition One possibility is to digitize the film and store it in the PACS archive, so the transition time to softcopy reading is going to be reduced. A good reason to proceed with this approach is that changing eyes from lightbox to display takes some time and reduces sensitivity on the displays. Elizabeth Wendy Breast Center

112 The Importance of Hybrid Information Management Compresses the time to a filmless environment Maximizes profitability: –Increase efficiencies, reduce costs & improve productivity Potentially improves patient care Reallocates staff to more strategic initiatives

113 To Digitize or Not... The Positives Interpreting PhysicianProviderReferring Physician/Patient Facilitates batch reading & report turnaround Enhanced image manipulation Increased accuracy of interpretations Increased ease of peer/specialist consultation Increased clinical efficiency – anytime, anywhere access to information –Better and faster decisions about treatment and diagnosis Deliver higher quality of care, positively impacting patient safety, access and affordability Free up critical floor space Lower film management costs –To store, retrieve, hang, review, take down and refile Reduce malpractice risks Decrease in additional imaging/imaging studies Faster turnaround times for patient results Rapid access to reports and images Optimize utilization of teleradiology/ telemammography Increased access to specialized services/ expert consults Increased patient/referring provider satisfaction

114 MQSA Regs on Digitization Digitization of hard copy priors allowed for comparison –Interpreting physician at same or other facility must approve of quality Cannot be used/sent out for primary interpretation Cannot take place of hard copy for retention purposes –Not considered a mammogram according to FDA definition so cannot be counted toward initial or continuing experience

115 Digitizer Mandates FDA recommends: –Digitizers approved or cleared by FDAs Office of Device Evaluation Images must be of sufficient quality to pass phantom and clinical review if submitted to Accrediting body

116 Conversion Considerations Format: MG (mammogram) for presentation DICOM format –Ensures ability to upload/display on your system Lossless not lossy image compression Digitized image quality evaluated by scanning previous true positive images and scan phantom Determine which films to digitize

117 Strategies – In-House or Outsourced Visit Iron Mountain to See Digitization Demo Booth 1007 On-Demand Conversion – manages costs –Historical studies are stored in physical format –Films are digitized as needed Hard copies are still retained Complete Conversion – too costly –All historical film studies are digitized Hard copies are still retained

118 Preparing For The Transition Analog CAD Processors Some … allow a user to digitize film- screen images for processing … and then store the digitized image as a standard DICOM MG (or digital mammography) object, –… allows the digitized image to be sent to PACS or to other DICOM nodes on the network. –Digital Mammography and Breast Imaging Implementation Guide – Release 7 – DR Systems 2007

119 Skin Marking In FFDM Why Use Skin Markers? Standardization Increases both Viability of Interpretations And Productivity Standardized Skin Markings Protocols Available at Beekley Booth #1224

120 If you were not given a guideline as to what each pellet refers to, would you be able to tell? Would have to refer to breast map or written patient history – not efficient and/or could lead to wrong conclusion

121 In my medical practice, I have seen a number of cases in which mammographic markers were incorporated, interpreted and harm to the patient resulted. Even within a single practice, I have seen different technologists and radiologists taking a nonstandardized approach to marking… These types of cases are difficult to defend, because the underlying malpractice reveals a lack of standardization within the profession. Richard M. Chesbrough, MD Diagnostic Imaging Magazine

122 A Standardized Approach To A…

123 A) Marking UTMADCC: MLO Mags Scar and Nipple Marking Study

124 Man-o-Grams So Important to Mark Correctly

125 Archival Issues For Processing or For Presentation

126 File Sizes Are Huge!!!

127 Digital Mammography: Integration Into a Practice by Laurie L. Fajardo, MD, MBA; and JeongMi Park, MD Imaging Economics, December 06

128 Archiving For Presentation (MG) Since we should consider storage costs and bandwidth For basic operation, archiving only the For Presentation images is adequate for most facilities. IHE

129 Archive For Processing (Raw) It is important to note that both review workstation and CAD systems may change their processing algorithm over time. –It may be viewed as a benefit or liability to reprocess the For Processing archived images with a different algorithm. –IHE –If store keep log of processing algorithm (software version) used at time of original interpretation.

130 IHE - Reasons to Store Both Examples include: –a specialty RWS that offers additional processing features that operate only on For Processing images. This usually only occurs when the acquisition modality vendor and review workstation vendor are of the same manufacturer. –CAD results can be re-generated from the archived data. Storing the CAD structured reports which are compact representations is more efficient and practical. »IHE

131 CAD To CAD or Not To CAD To Archive or Not To Archive

132 Strong Endorsement of CAD ACR - CAD or Double Readings –Double reading and computer-aided detection (CAD) may increase the sensitivity of mammography interpretation and may be utilized… realizing that cost and workforce issues make this difficult to accomplish at many facilities. –Practice Guidelines for Screening Mammography – effective 10/04 Insurance Companies –2004 – November - CIGNA announced CAD had become a standard of care for larger radiology practices. – In April, Aetna announced that it now considers CAD a medically necessary adjunct to mammography

133 Not To CAD? CAD took a hit …NEJM study found FP rate had a negative impact on the accuracy of mammography screening.

134 Did the NEJM findings …have any effect on the role of mammography CAD at your facility? Poll Results yes 0% no 100% Advance For Imaging And Oncology Administrators May

135 …two recent studies indicate that CAD still produces beneficial results when paired with a couple of new breast screening technologies, CR mammography and full-field digital mammography. Studies show CAD matches up well with CR mammo, FFDM 5/24/ By: Wayne ForrestWayne Forrest

136 Breaking News July CAD Reimbursement In Jeopardy

137 Not To CAD …an Oregon health insurer has stopped offering reimbursement for CAD "Based on (the NEJM study), ODS (…an Oregon health insurer) will no longer be covering CAD for any indication... effective July 22, 2007." –The decision could have major ramifications for the CAD industry should it ripple to other third-party payors. –"Until now, ODS has considered computer-aided detection experimental and investigational for all imaging services except when used in conjunction with mammograms," said medical director Dr. Csaba Mera. –ODS is a provider of dental, medical, and professional liability insurance that serves more than 600,000 Oregonians. »NEJM Study Prompts Oregon Payor To Cancel CAD Reimbursement 7/11/2007 By: Cynthia Keen

138 CAD Helps Support FFDM "The reimbursement is particularly attractive when you add on computer- aided detection [CAD]. How many patients will it take to payoff the FFDM machine w/CAD? –It would take approximately 6500 patients a year. »NCBC answers Courtesy Kodak - Carestream Health

139 Technologist Conducts 4-Image Exam, Reviews for Image Quality, & Presses SEND Button In less than 2 minutes, markers are available at the Review Workstation * CR CAD Both R2 and iCAD applied for FDA approval July 11, DR Direct to Digital CAD Digital productivity Not compromised

140 Who Is Responsible For Missed Diagnosis? Most vendors purchase agreements specify that the hospital and/or physician is responsible since CAD is currently not intended as an exclusive image screener The best course of action is to understand the contract and avoid overreliance on CAD-assisted reads. –Diane McKenzie, partner and chair of Neal, Gerber & Eisenbergs information technology group (Chicago) September 2004 HEALTHIMAGING.COM Digital Images Meet the Law by Lisa Fratt

141 Implications If marked eliminate concern or work it up –…a lesion marked by CAD, but disregarded by a radiologist, which ultimately turned out to be cancer, may constitute negligence by the radiologist. »An Appellate Court Ruling and Potential Implications for CAD Technology in the Courtroom - Greenberg Am. J. Roentgenol..2006; 186:

142 Important Point Great screening mammography begins and ends with great breast imaging, and CAD was always intended only to augment, never to replace the breast radiologist. Each practice … should assess the clinical value of CAD on an ongoing basis…in the same manner that it should be continually assessing the other performance metrics that define clinical quality." –Jerry Kold, NEJM study pans CAD, draws attention and criticism 4/5/ By: Erik L. RidleyErik L. Ridley

143 To Save or Not To Save? There is no clearly established medical-legal decisions or regulatory requirements –At this time the decision to archive or to dispose of CAD findings is left with the breast imaging practice. Traditionally, most facilities have selected not to archive CAD findings… –A trend is emerging however, where facilities are opting to archive CAD findings. –DR Systems Digital Mammography and Breast Imaging Implementation Guide - Release 7 – Jan 07

144 Erasing Or Destroying May Put You At Risk CAD marks vary with repeated processing of the same images due to change in software or type of unit used. Most experts believe that we should save the CAD marks. An Appellate Court Ruling and Potential Implications for CAD Technology in the Courtroom – Greenberg Am. J. Roentgenol..2006; 186:

145 If Not Saved Indicate in facility records the software generation used Update records with software changes Image courtesy of iCAD.

146 CAD Saved the Day Plaintiff suing for delayed diagnosis –CAD not performed by interpreting physician CAD performed by expert witness for the defense –It did not mark the area where the plaintiff developed breast cancer –Jury returned a unanimous verdict for the defendant »An Appellate Court Ruling and Potential Implications for CAD Technology in the Courtroom - Greenberg Am. J. Roentgenol..2006; 186:

147 Plaintiff filed appeal stating hearsay –Appellate court upheld the trial judge's admission of the evidence and affirmed the jury verdict, –CAD results were "a scientific analysis conducted by computer, which performed a series of complex mathematic calculations based on detailed information it drew from an x-ray. »An Appellate Court Ruling and Potential Implications for CAD Technology in the Courtroom - Greenberg Am. J. Roentgenol..2006; 186:

148 In Closing… Pearls of Digital Wisdom Must Be Able To Establish The: Quality Of The Image Adequacy Of Equipment Including Workstation Interpretation Environment Competency Of The Reviewer Spencer Studwell, senior associate general counsel, director of risk management, University of Rochester Medical Center, NY Vigilance key to managing risk in the digital world 5/15/2007 by Erik L. Ridley

149 Updates – sign up on FDA home page For policy questions, check the Policy Guidance Help SystemPolicy Guidance Help System Facility Hotline

150 For More Information contact me at To order the book MQSA Made Easy visit

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