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U.S. Department of Health and Human Services

Radiation-Emitting Products

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What statistical outcome data and biopsy results should facilities collect?

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Beyond the requirement that each facility must have a system for collecting outcome information, FDA has not established specific requirements for statistical data collection.However, some statistics that may be useful to the facility are the percent of exams interpreted as positive that have a positive pathology report, and the percent of exams interpreted as positive that do not have a positive pathology report. With respect to biopsy results facilities must attempt to collect biopsy data on whether the tissue sample is benign or malignant. Additional information, such as staging and size of tumors, would permit a facility to better evaluate its success in early detection of breast cancer. Facilities can refer to radiology journals for information regarding recommendations for the collection of biopsy data. This information should be given periodically to the interpreting physicians so that they can learn from biopsy results and correlate biopsy results with their interpretations.

Back to Medical Outcomes Audit Program

Back to Medical Outcomes Audit General Requirement