MQSA (Mammography Quality Standards Act) update--focusing on quality assurance

Abstract

To have uniform national standards, Congress passed the Mammography Quality Standards Act (MQSA) in 1992. Screening and diagnostic facilities must now meet minimum quality standards for personnel, equipment and recordkeeping, and be certified by the FDA, the federal agency designated to implement MQSA. The FDA is responsible for developing final standards, approving accrediting bodies, certifying all mammography facilities in the U.S., evaluating the effectiveness of the program, and implementing sanctions for noncompliant facilities. Congress recognized the urgent need for national mammography standards, but realized that 10,000 mammography facilities could not be certified to meet the regulations before October 1, 1994. President Clinton signed legislation granting the FDA Interim Rule authority and allowing the FDA to adopt existing standards from the ACR, HCFA and state regulations. The Final Rules have significant changes in the Quality Assurance (QA) Sections (900.12 d and e) and indicate where staff must now conduct, document and evaluate the results of QA tests, taking responsibility for establishing and maintaining a QA program that ensures safety, reliability, clarity and accuracy of the mammography services they perform. The Rules also specify the roles of interpreting physicians, medical physicists and quality control technologists. Data indicates that such regulation has improved mammography in the U.S. By January 1997, the Government Accounting Office reported that 1,500 facilities had undergone two rounds of MQSA inspections. During the first year of MQSA, 26 percent had significant violations, while only 10 percent did on the second round.