Medical Outcomes Audit Program
Citation:
900.12(f): Each facility shall establish and maintain a mammography medical outcomes audit program to followup positive mammographic assessments and to correlate pathology results with the interpreting physician’s findings. This program shall be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms.
900.12(f)(1): General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including followup 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 patients imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate followup on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.
Approved Alternative Standard:
Combined Mammography Medical Outcomes Audit for Multiple Mobile Mammography Units
Questions:
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What are the MQSA requirements for a medical audit and outcome analysis recordkeeping system?
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What statistical outcome data and biopsy results should facilities collect?
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Which mammograms must be included in the medical outcomes audit system?
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Must a facility establish a "system" to identify their false negative examinations?
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How should "false negatives" be included in the medical audit?
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Are medical outcomes audit data collected during facility inspections used in a national database?
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Is a particular staff person required to conduct the follow-up for positive mammograms?
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Where can a facility obtain more information about medical outcomes audit programs?