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
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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