FDA's Mammography Inspections

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.

GAO found that: (1) GAO's work points to growing compliance by facilities with FDA's mammography standards; (2) FDA's first annual inspection began in January 1995, and by mid-1996, over 9,000 facilities had been inspected, and approximately 1,500 of these had undergone two rounds of inspections; (3) the first time these 1,500 facilities were evaluated, 26 percent had significant violations, but the second-year inspection revealed that this figure had dropped to about 10 percent; (4) the percentage of facilities with less significant deviations from quality standards had decreased; (5) while these results are positive, GAO did note some differences in how inspectors are conducting inspections that, left unaddressed, 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; (6) GAO's review of FDA's actions during the first 18 months of its inspection program showed a need for management attention to two additional aspects of the inspection program; (7) FDA's inspection procedures for an important test of mammography equipment were inadequate; (8) the way this test, called the phantom image test, was conducted was open to variability, which could have resulted in differing assessments of how well the equipment functioned; (9) in those instances in which test results showed serious problems with the phantom image quality, FDA's procedures allowed facilities to continue taking mammograms without follow-up to evaluate whether their quality was actually acceptable; (10) without such follow-up review, women are not fully protected from getting poor mammograms from facilities with potentially severe quality problems; (11) at the time of GAO's review, FDA also lacked procedures to ensure that all violations of standards were both corrected and corrected in a timely manner; (12) FDA's program lacked criteria for defining conditions constituting a serious risk to human health, which could delay enforcement of compliance and notification to women who may have received substandard mammograms; (13) for facilities with less severe but persistent violations, FDA's follow-up efforts could not always ensure corrective action was taken; and (14) delays in completing a management information system have kept FDA's compliance staff from having complete, up-to-date information about the compliance status of all mammography facilities.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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