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Mammography
Today, statistics show that one out of every eight women will develop breast cancer at some point in their lives. Breast cancer is best treated when it is found early. Early detection of breast cancer is enhanced with a combination of monthly breast self-examination, physical examination by a physician, and mammography. A mammography exam is a special breast x-ray examination that can detect up to 90% of breast cancers.
Male breast cancer incidence is small but it is important to know that men can be affected by this disease also.
The Mammography Quality Standards Act of 1992 (MQSA) (42 USC 263b) was enacted to ensure that all women have access to quality mammography. Effective October 1, 1994, The Food and Drug Administration (FDA) required that mammography facilities be certified by a qualified certifying Agency. (FDA or an FDA approved certifying state)
The Illinois Emergency Management Agency certifies all mammography facilities in the State of Illinois except for those facilities exempted by 32 Ill. Adm. Code 370.40. To qualify for certification, a facility must first be accredited by an approved accrediting body. In Illinois, the only approved accrediting body is the American College of Radiology (ACR).
NOTICE: The Illinois Emergency Management Agency is no longer providing the "Your Right to Know" pamphlet. The pamphlets will continue to be available on this site for printing and duplicating.
Contacts
- Illinois Emergency Management Agency: (217) 785-9923.
- US Food and Drug Administration: (240) 276-3332.
- American College of Radiology: (800) 227-6440.
- Illinois Breast and Cervical Cancer Program: (888) 522-1282.
- MQSA Hotline: (800) 838-7715
Requirements
32 Ill. Adm. Code 370 establishes standards and certification requirements for facilities performing mammography to ensure that facilities are adequately and consistently evaluated for compliance. Mammography facilities are inspected annually.
To review these requirements Quality Standards and Certification Requirements for Facilities Performing Mammography.
Compliance Guidance
The FDA's website has an extensive Policy Guidance Help System that will provide answers to most regulatory questions.
Fees
Mammography facilities in Illinois are billed $1,300 annually, each July for certification and inspection. In addition, FDA bills facilities $548 for each inspection. Note: the FDA fees paid by facilities in non-certifying states are $2150 per inspection (plus an additional fee for multiple machines).