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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Highlights
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.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | 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. |
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.
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| Food and Drug Administration | 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. |
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.
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| Food and Drug Administration | 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. |
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.
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Topics
Breast cancerDisease detection or diagnosisHealth care facilitiesInspectionManagement information systemsMedical equipmentNoncomplianceQuality controlSanctionsWomenMammography