Mammography Quality Standards Act

The Mammography Quality Standards Act (MQSA) was enacted by the United States Congress to regulate the quality of care in mammography. The act was officially effective in 1994, and was extended in 2004 to contine through 2007. The FDA began inspections of mammography facilities to ensure compliance in 1995. In 1997, more comprehensive regulation was added to become effective in 1999.

The FDA explains MQSA: "The Mammography Quality Standards Act requires mammography facilities across the nation to meet uniform quality standards. Congress passed this law in 1992 to assure high-quality mammography for early breast cancer detection, which can lead to early treatment, a range of treatment options, and increased chances of survival. Under the law, all mammography facilities must: 1) be accredited by an FDA-approved accreditation body, 2) be certified by FDA, or its State, as meeting the standards, 3) undergo an annual MQSA inspection, and 4) prominently display the certificate issued by the agency."

Accrediting bodies
MQSA requires facilities to "be accredited by an FDA-approved accreditation body." Currently the only nationally-approved body is the American College of Radiology (ACR).

State-level alternatives to the ACR are the Arkansas Department of Health and Human Services, Iowa Department of Public Health, and Texas Department of State Health Services.

Effects on patients
MQSA is intended to maintain high quality mammography in the United States and its territories but many patients are unaware of its effects. Changes in the final regulations directly affecting regular patients include:


 * Mammography facilities are required to provide patients with written results of their mammograms in language that is easy to understand. Also known as a "lay report."
 * A consumer complaint mechanism is required to be established in mammography facilities to provide patients with a process for addressing their concerns.
 * Patients can obtain their original mammograms, not copies, when they are needed.
 * For cases in which a facility’s mammograms are determined to be substandard and a risk to public health, facilities will notify the patients and their doctors and suggest an appropriate plan of action.

Despite passage of the MQSA by congress in 1992 and the nearly 1 billion dollar cost, the aggregate sensitivity of mammography in the USA is similar to what it was in the 1970s.1,2.

1) Smart CR, Byrne C, Smith RA, Garfinkel L, Letton AH, Dodd GD, et al. Twenty-year follow-up of the breast cancers diagnosed during the Breast Cancer Detection Demonstration Project. CA Cancer J Clin 1997;47: 134–49.[Abstract]

(2) Rosenberg RD, Lando JF, Hunt WC, Darling RR, Williamson MR, et al. The New Mexico Mammography Project. Screening mammography performance in Albuquerque, New Mexico, 1991 to 1993. Cancer 1997;78: 1731–9.