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Quality Standards Compliance for Mammography Facilities

By October 1, 1994, all U.S. mammography facilities, except those managed by the Department of Veterans Affairs, must be certified by the Food and Drug Administration (FDA) to legally continue to provide mammography services. The requirement is a result of the Mammography Quality Standards Act of 1992 (MQSA), which requires national, uniform quality standards for mammography facilities* and is intended to ensure that all women have access to safe and effective mammography services for early detection of breast cancer. The law requires that:

  • To be certified, a facility must first be accredited by a federally approved private nonprofit or state accrediting body. As of August 18, FDA had approved the American College of Radiology (ACR) and the Bureau of Radiological Health, Iowa Department of Public Health, as accrediting bodies.

  • To be accredited, a facility must apply to an FDA-approved accrediting body; undergo periodic review of its clinical images; have an annual survey by a medical physicist; and meet quality standards for equipment, personnel qualifications, quality-assurance programs, and recordkeeping and reporting.

  • To maintain its certification, the facility must be inspected annually by federal or state personnel.

FDA was delegated the authority to implement MQSA in June 1993. On December 21, 1993, FDA published interim standards in the Federal Register covering equipment, personnel, quality assurance, and recordkeeping and reporting (1). The interim standards also set requirements that must be met by accrediting bodies. FDA is collaborating with the National Mammography Quality Assurance Advisory Committee to develop more comprehensive, final standards.

The accrediting bodies will provide FDA with the names and addresses of the facilities they have accredited. FDA will then issue certificates to all accredited facilities. FDA is also providing a series of training courses for federal and state inspectors, who must pass three written and two practical proficiency examinations before conducting inspections. Facilities will be subject to MQSA inspections as of October 1.

The MQSA program combines the elements of the ACR's voluntary Mammography Accreditation Program and the Medicare Screening Mammography Benefit program of the Health Care Financing Administration (HCFA). After October 1, HCFA will accept FDA certification as the basis for Medicare reimbursement, and HCFA inspections will cease.

Additional information about the MQSA program and subscriptions for FDA's quarterly newsletter, Mammography Matters, is available by calling (301) 443-4190; fax (301) 594-3306.

Reported by: Div of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, Center for Devices and Radiological Health, Food and Drug Administration.

Reference

  1. Food and Drug Administration. Mammography facilities: requirements for accrediting bodies and quality standards and certification requirements -- interim rules. Federal Register 1993; 58:67558-72. (CFR 21, Part 900).

* Public Law 102-539



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