Mammography is one of the most technically challenging radiological procedures, and ensuring the quality of the radiologic image is difficult. Among other things, MQSA requires that
FDA establish quality standards for mammography equipment, personnel, all mammography facilities be accredited by an FDA-approved accrediting body (either a nonprofit organization or a state agency) and obtain a certificate from FDA in order to legally provide mammography services after October 1, 1994; and all mammography facilities be evaluated annually by a certified medical physicist and be inspected annually by FDA-approved inspectors. Since early 1994, FDA has been working with the National Mammography Quality Assurance Advisory Committee to develop the final regulations. Quality of Mammography Services Has Improved

Early indications point to a general improvement in the quality of mammography services under the act. In implementing these requirements, FDA adopted the standards that had been set by ACR in its voluntary compliance program. Accreditation Process Has Produced Change at Many Facilities

MQSA called for facilities to comply with the new standards through an accreditation process. As a result, although some facilities have discontinued services, so far the number of closures is relatively small and access to services has not been significantly affected. As a result, as of July 26, 1995, FDA had not closed any facilities for noncompliance found during inspections. The costs associated with a system upgrade vary depending on the type and the extent of changes that are required. Mammography quality standards are now in place in all states, and these standards do not appear to have had a negative effect on access to services.
Why GAO Did This Study

Pursuant to a legislative requirement, GAO examined whether the Food and Drug Administration's (FDA) implementation of the Mammography Quality Standards Act has had any effect on the: (1) quality of mammography services; and (2) access to such services.

What GAO Found

GAO found that: (1) the act has had a positive effect on the quality of mammography services; (2) a uniformed set of standards for mammography services is required in all states; (3) many facilities have had to improve their services in order to become fully certified; (4) annual inspections of mammography facilities help ensure that these facilities are in compliance with the standards set by the American College of Radiology; (5) the number of facilities ceasing mammography services rather than complying with the quality standards is relatively small; and (6) FDA has not closed many of the facilities unable to meet the new certification requirements, but it has given them time to comply with the new quality assurance requirements and to correct the problems found during inspection.