FDA's Mammography Inspections:

While Some Problems Need Attention, Facility Compliance Is Growing

HEHS-97-25: Published: Jan 27, 1997. Publicly Released: Jan 27, 1997.

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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.

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 for Executive Action

  1. Status: Closed - Implemented

    Comments: In commenting on the draft of this report, FDA agreed with GAO's recommendations. In April 1997, FDA informed GAO that it had implemented corrective actions to address each of GAO's recommendations.

    Recommendation: FDA should strengthen the inspection reporting process. To better reflect the extent to which inspections detect compliance problems, FDA needs to monitor its inspection results more closely to ensure that its procedures for resolving open items and documenting on-the-spot corrections are consistently followed.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: In commenting on the draft of this report, FDA agreed with GAO's recommendations. In April 1997, FDA informed GAO that it had implemented corrective actions to address each of GAO's recommendations.

    Recommendation: FDA should strengthen procedures for assessing image quality and protecting patients. To minimize the variability in how phantom images are scored, additional training and guidance should be provided, including guidance for evaluating phantom images using the large image receptor. Also, to minimize patients' risk of poor quality mammograms, the final implementing regulations should include the criteria and process for requiring follow-up clinical image reviews and, when necessary, patient notification when inspections detect violations, such as serious phantom image failures, that could severely compromise image quality.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Implemented

    Comments: In commenting on the draft of this report, FDA agreed with GAO's recommendations. In April 1997, FDA informed GAO that it had implemented corrective actions to address each of GAO's recommendations.

    Recommendation: FDA should ensure that violations are corrected in a timely manner. Several steps are needed here. First, to help ensure that appropriate action is taken when serious problems are discovered, procedures need to be developed for: (1) determining when the health risk is serious enough to justify immediate suspension of certification; and (2) implementing the suspension. Second, to help ensure better performance from facilities that exhibit lingering, though less serious, deficiencies, the classification and enforcement policy on level 3 violations needs reevaluation to determine if additional follow-up is needed on facilities with multiple and repeated level 3 violations. Third, so that compliance personnel can have access to complete, up-to-date information on violations reported, all necessary steps need to be taken to ensure that the compliance tracking system currently under development is completed as soon as possible.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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