The interpreting physician must prepare a written report containing the results of each examination in addition to the following information:
Name of the patient and an additional patient identifier
Date of the examination
Name of the interpreting physician
An overall final assessment (The ACR strongly recommends that the assessment be categorized into one of the BI-RADS® final assessment categories)
Overall Final Assessment
|Highly Suggestive of Malignancy|
|Known Biopsy-Proven Malignancy|
|In cases where no final assessment can be assigned due to incomplete work-up, the ACR recommends that BI-RADS Category 0 (Incomplete: Need Additional Imaging Evaluation and/or Prior Mammograms for Comparison) should be used along with reasons why no assessment can be made.|
Further guidance is available in excerpted text from the BI-RADS® Atlas.
This written report, signed by the interpreting physician, must be provided to the patient’s health care provider within 30 days of the examination date. If the assessment is “suspicious” or “highly suggestive of malignancy,” reasonable attempts must be made to communicate this to the health care provider (or designee) as soon as possible. FDA guidance recommends no more than 3 business days.
In addition, the facility must send a written summary of the mammography report to the patient in terms easily understandable by a lay person (i.e., lay letter) within 30 days of the examination date. If the assessment is “suspicious” or “highly suggestive of malignancy” reasonable attempts must be made to communicate this to the patient as soon as possible: FDA guidance recommends no more than 5 business days. This applies to every patient who receives a mammogram, not only self-referred patients. The intent of this law is to address women’s concerns about breakdowns in communication that prevent timely and appropriate diagnosis and treatment of breast disease. Sample lay letters are available. If the patient is self-referred and has not named a health care provider, the facility must also send a copy of the written report to the patient.
Revision History for this Article
Description of Revision(s)
Article created; FAQs incorporated; No criteria changes
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