Mammography Quality Standards Act - History

History

In a nationwide survey of mammography facilities conducted in 1985, called Nationwide Evaluation of X-ray Trends (NEXT), the U.S. Food and Drug Administration found 36 percent to be producing mammographic images of unacceptable quality. The FDA also found that 15 percent of facilities were using general purpose X-ray equipment for mammography. The American College of Radiology responded by initiating a voluntary accreditation program for these facilities in August 1987 and found that 30 percent of facilities failed on their first application for accreditation.

Evidence from a 1990 General Accounting Office (GAO) study showed that many mammography providers lacked adequate quality assurance programs. From June 20 to 22, 1990, NBC Nightly News correspondent, Michelle Gillen presented a three-part series on the quality problems of mammography. In 1992, hearings held by the Senate Committee on Labor and Human Resources found numerous quality issues in the field of mammography.

Congress enacted the MQSA on October 7, 1992. Responsibility for implementing MQSA was delegated to FDA by the Secretary of the U.S. Department of Health and Human Services (DHHS) on June 2, 1993. The act became effective October 1, 1994, and requires all mammography facilities to meet quality standards as promulgated by the Food and Drug Administration (FDA). The FDA published interim regulations on December 21, 1993, as a mechanism for accreditating and certifying of facilities by October 1, 1994.

The FDA found 10,142 certified facilities operating, as of December 15, 1994. During the first year of MQSA, 26 percent of facilities had significant violations, while 10 percent did on the second round of inspections. On October 28, 1997, the FDA publish a set of comprehensive final regulations, which become effective on April 28, 1999, guiding the accreditation process. They accredited and certified 10,161 mammography facilities as of December 31, 1997.

A 1998 estimate concluded that inspections cost each facility $1,549 annually and the average cost to reach compliance with MQSA was $18,000. Costs of meeting the interim regulations, including staff training, equipment upgrades, enhancement of quality assurance programs, and improved notification of examination results to patients, was estimated to be $24 million annually. The additional cost of facility compliance with the 1997 regulations increased this figure to $62 million annually.

The number of certified facilities operating on December 31, 1997, was about 4 percent less than prior to when MQSA went into effect on October 1, 1994. Of the 369 closures just prior to October 1, 113 could be directly attributed to MQSA.

On November 9, 1997, the Senate passed S. 537, "The Mammography Quality Standards Reauthorization Act," by unanimous consent, to reauthorize MQSA for another 5 years.