Mammography Services

The Mammography Quality Standards Act of 1992 set nationwide minimum standards and required accreditation for mammography facilities, which prompted thousands of these facilities to improve their quality assurance processes. The Food and Drug Administration's (FDA) annual inspections of facilities, now in their third year, continue to show increasing compliance with these national quality standards. Further evidence of quality improvement can be seen in the quality of X-ray images. Before the act took effect, 11 percent of facilities tested were unable to pass image quality tests; the nationwide figure is now 2 percent. Experts agree that improving the quality of mammography images should lead to more accurate interpretation by physicians and, therefore, to improved early detection of breast cancer. However, neither data nor research methodologies are now in place to clearly establish these links. When the legislation was passed, concerns were raised that some women might have difficulty obtaining mammography services if facilities chose to shut down rather than upgrade their operations to meet the new quality standards. GAO found no indication that access problems had developed as a result of the act. FDA indicated that it has implemented GAO's earlier recommendations for strengthening the act's inspection program.

GAO noted that: (1) MQSA has increased mammography facilities' adherence to accepted quality assurance standards, which has had a positive effect on mammography services; (2) MQSA established nationwide minimum standards and required facility accreditation, which resulted in thousands of facilities' having to improve their quality assurance processes; (3) the Food and Drug Administration's (FDA) annual inspections of facilities, now in their third year, continue to show increasing compliance with these national quality standards; (4) further evidence of quality improvement can be seen in the quality of the X-ray images; (5) before the act took effect, 11 percent of facilities tested were unable to pass image quality tests; now, the nationwide figure is 2 percent; (6) experts agree that improving the quality of mammography images should lead to more accurate interpretation by physicians and, therefore, to improved early detection of breast cancer; (7) however, neither data nor research methodologies are now in place to clearly establish these links; (8) FDA has established federal qualification standards for physicians who interpret mammograms but has not established criteria for measuring interpretation accuracy; (9) comparable pre- and post-MQSA clinical data for measuring mammography performance and cancer outcome either do not exist or are too limited to be useful; (10) FDA's proposed final regulations require each facility to use its own data to monitor physicians' performance on interpretation; (11) the National Cancer Institute has established a Breast Cancer Surveillance Consortium of nine research projects, which are making progress in both developing a methodology and collecting clinical data for assessing trends in mammography performance in detecting breast cancer and reducing mortality; (12) when MQSA was enacted, concern was expressed that some women might have difficulty obtaining mammography services if facilities chose to close down rather than to upgrade their operations to meet the new quality standards; (13) GAO found no indication that access problems had developed as a result of MQSA; (14) nationwide, the number of facilities that stopped offering mammograms was nearly offset by the number of new entrants into the field; (15) 92 percent of all facilities that closed were within 5 miles of a facility that remained open, and GAO's discussions with officials in states with the highest closure rates did not reveal any evidence that access problems had occurred; and (16) FDA has informed GAO that it has acted to strengthen the MQSA inspection program.