Quality issue must move beyond mammography

March 26, 2007

Trails blazed in medicine often bring controversy and even consternation. Breast care is no different. Since 1965, when the American College of Radiology formed the Committee on Mammography, advances in breast imaging and legislation to ensure its quality have largely centered on x-ray mammography.

Trails blazed in medicine often bring controversy and even consternation. Breast care is no different. Since 1965, when the American College of Radiology formed the Committee on Mammography, advances in breast imaging and legislation to ensure its quality have largely centered on x-ray mammography. Today, however, breast imaging centers employ a wide spectrum of imaging modalities that add clinical information to the diagnostic process. As Congress reviews the Mammography Quality Standards Act for reauthorization, it must take into account the continued evolution of breast imaging and ensure that additional breast imaging modalities are held to the same high standards as mammography.1-4

The MQSA, introduced in 1992 by Congress and appropriated for a five-year reauthorization cycle, hit a snag in 2003. Varying opinions on how best to improve the act without untoward effects led Congress to approve in 2004 legislation granting a one-time three-year reauthorization. Congress commissioned several studies to be conducted and planned to review their results in 2007 to determine if MQSA standards were in need of revision and/or expansion.2,3,5,6

The following are three of those studies:

  • Institute of Medicine. Congress petitioned the IOM to begin an Improving Mammography Quality Standards study. Upon its completion, the study was entitled Improving Breast Imaging Quality Standards.4 The report provided recommendations, among which were ways to improve mammography quality and interpretation, maintain availability of qualified personnel, and implement new technology without jeopardizing access.

  • National Mammography Quality Assurance Advisory Committee. This committee met once in 2005 and once in 2006 to gather information and provide recommendations regarding possible reorganization of FDA-related regulatory issues for the MQSA. With recognition of the IOM study, the committee addressed whether other breast imaging modalities and procedures should be federally regulated.4,7,8

  • Government Accountability Office. Congress requested a GAO study to include statistical information on the adequacy and capabilities of mammography services and the effect that facility closures might have on the breast care system. The results concluded that although facilities, machines, and staff had decreased over the recent three-year period, nationwide capacity was adequate. The study expressed concerns about future staffing and service due to the growing eligible population.9

The MQSA is approaching a new era in breast care delivery. The IOM study highlighted many issues in need of change. Centers of excellence with quality initiatives will set higher standards. More important, with the growing evolution of technology, the MQSA needs to regulate the newest imaging and diagnostic approaches in breast care to assure patient safety and high quality standards.

Currently, no standards are mandated for image-guided breast biopsies or other breast imaging technologies, such as ultrasound and MRI. There are three accreditation programs for breast ultrasound, for example, and the ACR's standards are by far the highest.10-12

What is needed is a single breast ultrasound accreditation program that reflects the highest standards to assure patients the best care. New technologies are gaining ground in the advancement of breast cancer diagnosis and interventions; however, these are not included under the auspices of the MQSA, because the imaging modalities do not use x-ray.

The MQSA, therefore, needs to evolve into the BIQSA-Breast Imaging Quality Standards Act-and move beyond what is to what should be. Breast imaging should be performed by dedicated physicians who have appropriate training and qualifications/accreditations, maintain high standards of care, and observe continuing quality review. The time to influence reauthorization is at hand, rather than waiting another five years for the next reauthorization. The BIQSA could be the start of a new direction that provides needed universal consistency in breast care.

Ms. Wagner is a retired ICU and home IV therapy nurse now working as a full-time patient advocate informing women of their breast biopsy choices and where to receive quality breast care. She can be reached at rwagner12@wi.rr.com.

References

  • Bassett, LW, Gold, RH, Widoff, BE. Highlights from the history of mammography, Radiographics 1990;10:1111-1131.

  • The Mammography Quality Standards Act Bill Number: Oversight, Hearing Date: April 8, 2003.

  • Mammography Quality Standards Reauthorization Act of 2004 (HR 4555) (Oct. 09, 2004) The Library of Congress-THOMAS.

  • Nass S, Ball J. Committee on Improving Mammography Quality Standards. Improving breast imaging quality standards. National Academies Press, 2005.

  • Department of Health and Human Services, Office of the Assistant Secretary for Legislation, Testimony on the Mammography Quality Standards Act (MQSA) of 1992 by D. Bruce Burlington, M.D., May 8, 1998.

  • Bassett LW, Monsees BS, et al. Survey of radiology residents: breast imaging training and attitudes. Radiology 2003;227:862-869.

  • Radall J. FDA considers recommendations of mammography quality. JNCI 2005;97(23):1721-1722.

  • MQSA Advisory Committee Meetings Summaries and Transcripts-CDRH Advisory Committee Data Base.

  • GAO Report to Congressional Requestors-Mammography, current nationwide capacity is adequate, but access problems may exist in certain locations. July, 2006.

  • American College of Radiology. ACR practice guideline for the performance of a breast ultrasound examination, 1994 (revised 1998, 2002; amended 2006). Available online. Accessed Sept. 28, 2006.

  • American Institute of Ultrasound in Medicine. AIUM standard for the performance of breast ultrasound examination, 2002. Available online. Accessed Sept. 28, 2006.

  • The American Society of Breast Surgeons: Performance and practice guidelines for breast ultrasound. Available online. Accessed Oct. 8, 2006.

  • Rauf D. Mammographer shortage fails to subside, www.DiagnosticImaging.com, May 6, 2005.

  • Eklund GW. Shortage of qualified breast imagers could lead to crisis. Diagn Imaging 2000;22(4):31-33,69.

  • Mammography Quality Standards Reauthorization Act of 2003, (S 1879) (Senate, Dec. 9, 2003) The Library of Congress-THOMAS.