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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Is it necessary to include an assessment code (e.g. 0, 1, 2, 3, 4, 5 or N, B, P, S, M, A), in addition to the assessment category, on all mammography reports? Is there a specific reporting format required?

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The answer to both questions is “No.” In order to promote consistency and clarity in the interpretation of mammograms, the final regulations require that each mammographic report include an overall final assessment of the mammography examination, classified into one of the following six categories:Negative, 

Benign, Probably Benign, Suspicious, Highly Suggestive of Malignancy, and Incomplete: Need additional imaging evaluation. While the final assessment findings must not vary from these categories and must be stated as written above, limited flexibility is allowed for further description as long as it doesn’t change the meaning of the category. The following are considered equivalent to the wording listed in the final regulations and are acceptable final overall assessments. 

Negative

Negative Mammogram

Benign

Benign Finding, Benign Findings, Benign Abnormality, Benign Abnormalities, Benign Mammogram

Probably Benign

Probably Benign Finding, Probably Benign Findings, Probably Benign Abnormality, Probably Benign Abnormalities, Probably Benign- Short Interval Follow-up Suggested, Probably Benign Finding - Short Interval Follow-up Suggested, Probably Benign Mammogram

Suspicious

Suspicious Finding, Suspicious Findings, Suspicious Abnormality, Suspicious Abnormalities, Suspicious for Malignancy, Suspicious of Malignancy, Suspicious Abnormality - Biopsy Should Be Considered, Suspicious Finding - Biopsy Should Be Considered, Suspicious Mammogram

Highly Suggestive of Malignancy

Highly Suggestive for Malignancy, Highly Suggestive of Malignancy - Appropriate Action Should Be Taken

Incomplete: Need Additional Imaging Evaluation

Incomplete: Needs Additional Imaging Evaluation, Incomplete: Additional Imaging Evaluation Needed, Incomplete: Need Additional Imaging Evaluation- Comparison with Prior Studies, Incomplete: Need additional imaging evaluation and/or prior mammograms for comparison, Incomplete: Need prior mammograms for comparison, Need Additional Imaging Evaluation (the term "Incomplete" can be inferred in this example as this is the only Incomplete BIRADS assessment category), Incomplete Mammogram: Need Additional Imaging Evaluation

Known Biopsy Proven Malignancy

Known Biopsy Proven Cancer, Known Malignancy, Known Cancer

Post Procedure Mammograms for Marker Placement

There is no requirement that any specific assessment code be assigned to these assessments. Also, there is no specific reporting format required for the report, apart from the requirement that an overall assessment category be included within it.

Also see Approved Alternative Standards

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