Mammography Facility Standards

by Food and Drug Administration (FDA)

No news is good news, the maxim goes, and when a woman is told that her mammogram shows no evidence of cancer, that's good news indeed. But the "good news" can turn into bad if tumors are missed because of poor mammography. Undetected, and thus untreated, the cancer advances.

Last December, the Food and Drug Administration published in the Federal Register interim final regulations intended to ensure that all mammography done in the United States is safe and reliable. They are a crucial step in implementing the Mammography Quality Standards Act (MQSA), enacted by Congress in 1992 in response to concerns that mammography was not being practiced to uniformly high standards at all facilities. Senator Barbara Mikulski (D-Md.), who cosponsored the bill, was instrumental in ensuring its passage and funding. In June 1993, the assistant secretary for health delegated to FDA responsibility for implementing and enforcing the new law.

Breast cancer is the second leading cause of cancer deaths in American women. According to U.S. Public Health Service (PHS) figures, nearly half a million women will die of breast cancer in the 1990s, and more than one-and-a-half million new cases will be diagnosed in that time.

Mammography — a special x-ray examination of the breast — is the most effective method for detecting breast tumors early, when the disease is most successfully treated. It can find 85 to 90 percent of breast cancers in women over 50 and can discover a tumor up to two years before a lump can be felt.

Widespread screening of women over 50, followed by prompt treatment when needed, can reduce breast cancer deaths by as much as 30 percent, according to PHS. This striking statistic underscores the need for accurate mammography. The x-ray images must be of high quality, they must be read by physicians proficient in interpreting them, and the results must be reported promptly.

Under the MQSA, no mammography facility — whether in a hospital, doctor's office, mobile van, military base, or any other public or private enterprise — will be able to operate legally after Oct. 1, 1994, unless it is accredited and federally certified as meeting quality standards. All will be subject to federal inspection and certification. After initial certification, facilities must pass annual inspections by approved federal or state inspectors.

(Veterans Administration hospitals are exempt from the law. However, the House Committee on Veterans Affairs has stated it will take steps to ensure that mammography in veterans facilities is subject to the same quality standards required by the MQSA.)

The regulations published last December became effective in February. Facilities must comply with standards covering:

• quality assurance and quality control
• radiological equipment
• personnel qualifications for the technicians who perform mammography, physicians who interpret the mammograms, and medical physicists who are required to survey the facilities annually
• medical record-keeping and disposition of written reports of mammography examinations.

The regulations also include standards for approval of accrediting bodies that will evaluate the facilities and review films for image quality.

Also as required by the MQSA, FDA established a National Mammography Quality Assurance Advisory Committee, which advises the agency on developing quality and personnel standards, and on monitoring the entire program.

Time Crunch

FDA found a challenge in implementing the MQSA by the mandated deadlines. The law contains two significant dates: July 22, 1993, for completion of all federal mammography standards, and Oct. 1, 1994, for certification of facilities.

"These dates were virtually impossible to meet if we followed standard procedures," says Richard Gross, an assistant director in FDA's Office of Training and Assistance in the Center for Devices and Radiological Health. "The administrative procedures for writing and publishing complex standards typically take two years. They require notice of a draft rule, opportunity for public comment, analysis of the comments and revision of the rule, and publication in the Federal Register with an effective date. Establishing an advisory committee also requires time to follow procedures set by the Federal Advisory Committee Act."

Nevertheless, standards had to be published so that facilities could be certified by the Oct. 1 deadline. Facilities not certified could not lawfully operate.

Working together, Congress — particularly Senator Mikulski and Representative John Dingell (D-Mich.) — and the Department of Health and Human Services solved the problem by giving FDA authority to issue an interim final rule, enforceable 60 days after publication. The interim final regulations include standards essentially the same as those developed by the American College of Radiology (ACR) for its voluntary program of mammography accreditation. (With minor modifications to its standards, ACR can apply for and be approved as an accrediting body.) Since more than half the facilities have already been accredited by ACR and another 20 to 30 percent had applied by the time the interim final regulations were published, federal certification is expected to proceed smoothly and quickly.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.