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Executive Summary
Pages 1-15

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From page 1...
... When screening mammography was widely adopted for breast cancer detection in the 1980s, facilities across the country varied considerably with regard to image quality and radiation dose. A voluntary accreditation program achieved limited gains, primarily due to low participation rates, so Congress passed the Mammography Quality Standards Act (MQSA)
From page 2...
... Improve breast imaging quality beyond mammography 10. Mandate accreditation for nonmammography breast imaging methods that are routinely used for breast cancer detection and diagnosis, such as ultra sound and magnetic resonance imaging (MRI)
From page 3...
... who are subsequently diagnosed with breast cancer) · Cancer detection rate per 1,000 women · Abnormal interpretation rate (women whose mammogram interpretations lead to additional imaging or biopsy)
From page 4...
... B) Combining medical audit data for screening with diagnostic examinations, as is permitted under current MQSA regulations, confounds the meaning of the results, making it difficult to interpret and compare performance with current literature or established databases.
From page 5...
... B) A central data and statistical coordinating center, independent of a regulatory authority, should be established and maintained to collect and analyze the advanced audit data to provide feedback to interpreting physicians for quality assurance and interpretive improvement.
From page 6...
... However, data are lacking on how feedback can best be used to improve performance, so studies are needed to optimize the impact of this approach. The statistical coordinating center could also aid the basic required audits by developing national benchmarks that facilities and interpreting physicians could use to assess their performance, and by testing the impact of the basic audit procedures.
From page 7...
... Supportive elements such as feedback and protection of quality improvement data to improve interpretive performance may not be implemented as easily as regulations, but in their absence, the advanced audit would be viewed primarily as an added burden by mammography facilities and personnel, thereby limiting the number of facilities that participate. Recommendation 3: Establish a demonstration and evaluation project to designate and monitor the performance of specialized Breast Imaging Centers of Excellence that attempt to incorporate aspects of successful organized breast cancer screening programs.
From page 8...
... It is urgent to further test the concept by designating specialized Centers of Excellence in Breast Imaging that would strive to achieve a higher level of integration, performance, and quality assurance in breast cancer detection and diagnosis by adopting many components of successful organized programs. This multifaceted approach should contribute to the optimal performance of mammography, but mammography is not the only imaging tool used for breast cancer diagnosis.
From page 9...
... Rationale: A) Requiring that a portion of MQSA-mandated CME be dedicated to mammography interpretive skills assessment could enable interpreting physicians to identify weaknesses and take steps toward improving interpretive performance.
From page 10...
... Volume alone cannot contribute to improvement unless it is accompanied by accurate feedback about performance. Given the uncertainty regarding the isolated effect of reader volume on interpretive performance, and given that increasing the minimum reader volume could reduce the supply of mammography services in some areas, maintaining access should be of primary concern.
From page 11...
... E) The requirement for modality-specific CME should be eliminated for interpreting physicians to allow them a broader choice of educational opportunities, including those that focus on interpretation skills.
From page 12...
... Furthermore, FDA data suggest that the number of interpreting physicians is decreasing. However, no systematic data collection and analysis has been undertaken, making it difficult to assess the current capacity for breast cancer screening and diagnostic services, and even more difficult to plan for the future.
From page 13...
... Collection of workforce and capacity data would also simplify documentation of staff qualifications and continuing education and experience requirements. Recommendation 8: Devise strategies to retain highly skilled breast imagers and increase the number of new entrants into the breast imaging field, particularly in underserved areas.
From page 14...
... Permitting nonphysician clinicians with special training to serve as second readers, only under the direct supervision of MQSA-certified interpreting physicians, could provide a cost-effective way to expand the use of double reading. Several small studies already suggest that this approach is feasible in mammography.
From page 15...
... Recommendation 10: Mandatory accreditation for breast imaging methods not utilizing ionizing radiation that are routinely used for breast cancer detection and diagnosis should be required under the next MQSA reauthorization. This would entail a name change to the Breast Imaging Quality Standards Act (BIQSA)


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