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U.S. Department of Health and Human Services

Radiation-Emitting Products

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MQSA Alternative Standard #7: Combined Mammography Medical Outcomes Audit for Multiple Mobile Mammography Units

FDA approved this alternative standard on November 4, 2002 and amended it on December 3, 2002. The amended alternative standard became effective on the latter date. It has no time limit. Some accreditation bodies accredit each mobile unit separately, even if two or more units are under the same ownership. This approach leads to each mobile unit being certified as a separate facility. Therefore, before the alternative requirement became effective, a separate mobile medical outcomes audit had to be performed for each unit. This alternative allows owners of multiple mobile mammography units to perform a combined mammography medical outcomes audit for all of the units if the specified conditions are met.

The original standard is 21 CFR 900.12(f)(1), which states:

21 CFR 900.12(f)(1): General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among women imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.

The approved alternative, as amended, is:

21 CFR 900.12(f)(1): General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among women imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy. In situations where multiple mobile mammography facilities are under the same ownership, they may be treated collectively as a single "facility" for the purposes of meeting these requirements, if all of the following conditions are met.

(i) Each facility must consist of a single mobile mammography unit.
(ii) The same entity or group administers the operation of all of the included mobile facilities.
(iii) The same lead interpreting physician has the responsibility for assuring that all of the included mobile facilities meet the requirements of 21 CFR 900.12(d) through (f).
(iv) The same group of radiologists read all of the images from all of the included mobile facilities.
(v) All of the included mobile facilities provide services to the same patient population.

 

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