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On October 28, 1997, FDA published MQSA final regulations, which became effective in April 1999 (FDA, 2002a). MQSA regulations include several key components (see Chapter 3 for more detail). First, FDA established national quality standards. Mammography personnel, including interpreting physicians, radiologic technologists, and medical physicists, are required to meet initial and continuing education and experience requirements. Only equipment specifically designed for mammography can be used. Documentation of the daily, weekly, quarterly, semiannual, and annual quality control tests performed at the facility must be retained for FDA annual inspections.

Html INTRODUCTION 17 the entire set is critical for achieving the objective of further improving the effectiveness of breast cancer detection. In particular, adopting supportive elements in conjunction with additional regulatory requirements will be essential to sustain access to breast imaging services. Increasing regulation without providing financial and other support could not only fail to improve quality but could also result in decreased access. In addition, although this report was intended to inform the next reauthorization of MQSA, which is now projected for 2007, most of these recommendations could and should be implemented immediately.

1995). However, oversight was minimal at best. Clinical images were not evaluated for quality, and facilities merely claimed to meet the given standards (Barr, 2004). In 1991 and 1992, the Senate Committee on Labor and Human Resources1 discussed the quality of mammography programs across the country as part of a larger hearing on breast cancer. It was noted that the “patchwork of Federal, State, and private stan1 The name of this committee was changed to Committee on Health, Education, Labor, and Pensions on January 19, 1999.

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