Mammography Services

Initial Impact of New Federal Law Has Been Positive Gao ID: HEHS-96-17 October 27, 1995

The Mammography Quality Standards Act of 1992 imposed uniform standards for mammography in all states, requiring certification and annual inspection of mammography facilities. GAO found that the act has had a positive impact, resulting in higher quality equipment, personnel, and practices. Mammography quality standards are now in place in all states, and these standards do not appear to have hampered access to services. To avoid large-scale closure of facilities, however, the Food and Drug Administration settled on an approach that allowed some delay in meeting the certification requirements. For this and other reasons, such as the availability of outcome data, more time will be needed before the act's full impact can be determined. GAO is required to assess the effects of the act again in two years and to issue a report in 1997.

GAO found that: (1) the act has had a positive effect on the quality of mammography services; (2) a uniformed set of standards for mammography services is required in all states; (3) many facilities have had to improve their services in order to become fully certified; (4) annual inspections of mammography facilities help ensure that these facilities are in compliance with the standards set by the American College of Radiology; (5) the number of facilities ceasing mammography services rather than complying with the quality standards is relatively small; and (6) FDA has not closed many of the facilities unable to meet the new certification requirements, but it has given them time to comply with the new quality assurance requirements and to correct the problems found during inspection.



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