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The Legal and Regulatory Impact of Digital Mammography

The Legal and Regulatory Impact of Digital Mammography. Monday, July 9,2007 2:30 – 4 PM. Presented by Bonnie Rush, RT(R)(M)(QM) President, BIS – Breast Imaging Specialists Consulting, Education and Community Outreach Author, MQSA Made Easy www.mammobis.org Brush4info@aol.com

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The Legal and Regulatory Impact of Digital Mammography

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  1. The Legal and Regulatory Impact of Digital Mammography Monday, July 9,2007 2:30 – 4 PM Presented by Bonnie Rush, RT(R)(M)(QM) President, BIS – Breast Imaging Specialists Consulting, Education and Community Outreach Author, MQSA Made Easy www.mammobis.org Brush4info@aol.com 858-277-2213 phone/fax

  2. Co-sponsored by Beekley Corporation Radiology Skin MarkersBreast Biopsy Accessorieswww.beekley.com&Iron Mountain Records Management Companywww.ironmountain.com

  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 It’s Peak Capabilities? Fatty Tissue and Masses Glandular Tissue and Microcalcifications

  6. Film Characteristics – Tied to H&D CurveDensities 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 carcinomahave 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 (49.500 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 http://www.acrin.org/dmist_qa.html

  13. Maintaining Patient Base In Analog"Fast Facts" http://www.acrin.org/dmist_fastfacts.html 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 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 DivideOffering 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? • ~ 2003 - 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-up’s 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 EnvironmentBy 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 CertificationHow 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 facility’s 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. 900.4. 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 ABConfirm CA received info Begin patient exams

  32. And Then…. The Hard Part Begins 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

  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 TransitionBecoming proficient in a digital worldvol. 20, RT Image no. 13 -- March 26, 2007By Tammy Coryell, RT(R)(M)

  35. Nowhere to Hide!

  36. Screen-Film and Digital Comparison 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 CATheir requirements are the same as the FDA’s

  38. AB Contact Information • American College of Radiology (ACR)Mammography Accreditation Program1-800-227-6440 • Arkansas Department of Health and Human ServicesDivision of HealthRadiation SectionMammography Program1-501-661-2301 • Iowa Department of Public HealthBureau of Radiological HealthMammography Program1-515-281-3478 • Texas Department of State Health ServicesRadiation Control Program1-512-834-6688

  39. AB’s and Units They Approve

  40. CA Contact Information • MQSA Facility hotline at 1-800-838-7715 or by e-mail to MQSAhotline@hcmsllc.com. • State of Illinois - Office of Radiation Safety - MAP Department of Nuclear Safety 1035 Outer Park Drive Springfield, IL 62704 217-785-9974 • Iowa Department of Public Health Lucas State Office Bldg., 5th Floor 321 East 12th Street Des Moines, Iowa 50319 515-281-3478 • State of South CarolinaMammography Certification Program Department of Health and Environmental Control 2600 Bull Street Columbia, SC 29201 803-545-4400

  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 900.12(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 manufacturer’s tests and testing procedures and updates - software changes)

  46. Medical Physicist's Equipment Evaluation and Annual Survey Formsand Approved Alternative Requirements For Each Manufacturer Available at www.acr.org - link to the following 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/UpgradesConsidered Major RepairsApproved 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/RepairsListed in the MQSA Policy Guidance Help System (PGHS)Listed in the manual MQSA Made EasyExhibit 6: Medical Physicist Involvement in Equipment Repairs

  50. Personnel Requirements Initial Modality Specific Training Continuing Education

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