United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Health, Education, and Human Services Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1997-01-27 monographic deposited born digital 43 p. GA 1.13:HEHS-97-25 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-97-25 P0b002ee18038da52 f:he97025 DGPO 2010-08-12 2011-03-28 GAOREPORTS-HEHS-97-25 machine generated eng fdlp REPORT GAOREPORTS-HEHS-97-25 HEHS-97-25 Breast cancer Disease detection or diagnosis Medical equipment Women Management information systems Quality control Inspection Noncompliance Sanctions Health care facilities FDA Mammography Certification Program FDA Automated Mammography Facility Inspection Database FDA Inspector Audit Program California Illinois Michigan Arizona Georgia Louisiana North Carolina Washington Letter Report HEHS

Pursuant to a legislative requirement, GAO reviewed the Food and Drug Administration's (FDA) program for implementing the requirements of the Mammography Quality Standards Act of 1992, focusing on: (1) the extent to which facilities are complying with the new mammography standards; (2) whether FDA's procedures for evaluating image quality at mammography facilities are adequate; and (3) whether FDA's monitoring and enforcement process ensures timely correction of mammography deficiencies.<p/>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 abo* https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-97-25/html/GAOREPORTS-HEHS-97-25.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-97-25/pdf/GAOREPORTS-HEHS-97-25.pdf GAO/HEHS-97-25 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-97-25 Letter Report GAO/HEHS-97-25; FDA's Mammography Inspections: While Some Problems Need Attention, Facility Compliance Is Growing; Breast cancer Disease detection or diagnosis Medical equipment Women Management information systems Quality control Inspection Noncompliance Sanctions Health care facilities FDA Mammography Certification Program FDA Automated Mammography Facility Inspection Database FDA Inspector Audit Program California Illinois Michigan Arizona Georgia Louisiana North Carolina Washington Title 42 Section 263b(i)(2) 42 U.S.C. 263b(i)(2)