As of July 1996, almost 10,000 facilities had been accredited and had received an FDA certificate to that effect. FDA, which has contracted with virtually all states and territories to conduct inspections, began its first annual inspections of the nation’s mammography facilities in January 1995. FDA’s field offices are responsible for following up on inspection violations and enforcing facility compliance. 1). Another measure of facilities’ improvement in compliance is the extent of repeat violations, that is, violations identified in the first year’s inspection that are identified again when the facility is reinspected the following year. These differences may have resulted in inconsistent reporting of violations; moreover, these inconsistencies make it difficult to determine the full effect of the inspection process. We identified a need for FDA to clarify the procedures it requires for a major equipment test that evaluates image quality and to follow up when test results suggest problems with the quality of the images being produced. Issues in Evaluating Phantom Image Test Results

One of the most important aspects of the inspection process is testing mammography equipment by evaluating what is called a “phantom image.” In this procedure, the inspector uses the facility’s mammography equipment to take an X-ray image of a plastic block containing 16 test objects. FDA’s procedures allow facilities with serious phantom image failures to continue performing mammograms while FDA investigates and the facility corrects problems. At the time of our review, FDA did not have a follow-up system in place for reviewing the actual mammograms (called “clinical images”) of facilities with serious phantom image violations to ensure that they were not producing poor mammograms. FDA’s Monitoring and Enforcement Process Does Not Ensure Timely Correction of Deficiencies

Although FDA has made progress in bringing facilities into compliance with mammography standards, it lacks procedures to enforce timely correction of all deficiencies found during inspections. One major problem involves the need to develop criteria for defining conditions constituting a serious risk to human health and determining when severe sanctions are warranted. FDA is developing such an information system. Our reviews at three of FDA’s field offices showed that these interim systems were inadequate. To determine whether field offices were sending out warning letters in a timely manner and whether facilities were correcting their deficiencies within required time frames, at our request, FDA headquarters in April 1996 sent all of its field offices a list of all level 1 and level 2 violations cited in their jurisdictions and asked them to compile data on facility response times for corrective actions. Field offices had difficulty responding with complete information. Establishing this comprehensive inspection program has been a substantial effort on FDA’s part and, as mammography facilities move into their second year of inspections, violations of mammography standards are declining. First, to ensure an accurate picture of how many problems were found and how well the inspection program was working, violations would need to be more consistently recorded. Strengthening procedures for assessing image quality and protecting patients. Comments From the Food and Drug Administration and Our Evaluation

The following are GAO’s additional comments on the letter received from the Food and Drug Administration dated November 18, 1996.
Why GAO Did This Study

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.

What GAO Found

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.