Summary: To address concerns about the quality of mammography services offered by more than 10,000 facilities throughout the United States, Congress passed legislation in 1992 requiring the accreditation and annual inspection of mammography facilities. The results of the Food and Drug Administration's (FDA) current mammography facility inspection program are encouraging. By mid-1996, more than 9,000 facilities had been inspected, and about 1,500 of these had undergone two rounds of inspections. The first time these facilities were evaluated, more than one-quarter had significant violations; during the second-year inspection, this figure had dropped to about 10 percent. Also, the percentage of facilities with less significant deviations from quality standards had decreased. However, GAO did note some differences in how inspectors are conducting inspections that could lead to inconsistent reporting of violations, thereby limiting FDA's ability to determine the full effect of the inspection process and to identify the extent of repeat violations. Moreover, GAO's review of FDA actions during the first 18 months of the inspection program revealed two problem areas. First, FDA's inspection procedures for an important test of mammography equipment were inadequate. Second, FDA lacked procedures to guarantee that all violations of standards were both promptly and adequately corrected.
