United States Congress passed the Mammography Quality Standards Act (MQSA) in 1992 after the Senate Labor and Human Resources Committee found numerous shortcomings in the quality of mammography services. The committee identified inconsistencies in the quality of equipment, staff qualifications, quality assurance procedures and oversight in mammography facilities which threatened the quality of services across the country.
The goal of MQSA was to create a system to correct these shortcomings and ensure that quality mammography would be available to patients everywhere in the country. At the same time, however, MQSA was not intended to close down facilities; it was intended to help them raise their standards of performance. Reducing availability of mammography through overbearing regulation would defeat the underlying purpose of MQSA.
The need to improve our ability to fight breast cancer also led to the development of the final regulations published October 28, 1997, in the Federal Register. These final regulations were developed through a cooperative effort with affected medical communities, consumers and the National Mammography Quality Assurance Advisory Committee (NMQAAC). Interim regulations allowed the MQSA to take effect October 1, 1994.
The US Food and Drug Administration's (FDA) Division of Mammography Quality and Radiation Programs oversees the requirements of MQSA. MQSA requires mammography facilities to have accreditation from an approved accreditation body, be certified by the FDA and undergo an annual inspection.
MQSA requires facilities to meet standards in the following areas:
- Equipment performance (including image quality and radiation dose)
- Technologist and physicist quality control/quality assurance tests and tasks
- Medical audit and outcome analysis records
- Medical records (mammography reports and films)
- Personnel qualifications and records
The North Dakota Radiation Control Program (RCP) has a contract with the FDA to inspect mammography facilities in North Dakota. The MQSA inspectors must be certified by the FDA. Certification requires 6 weeks training, as well as the passing of both written and performance evaluations. North Dakota has two certified inspectors. To maintain certification, inspectors must perform a minimum of 12 inspections annually and obtain 15 hours of mammography education every three year period. The FDA conducts audit inspections with each inspector on an annual basis. Annual facility inspections have been conducted since 1992.
The FDA currently maintains a listing of certified mammography facilities (updated weekly).