The Mammography Quality Standards Act (MQSA) requires that "a summary of the written report shall be sent directly to the patient in terms easily understood by a lay person." This applies to every patient who receives a mammogram, not only self-referred patients. Failure to comply with this reporting requirement will result in a citation by FDA inspectors. Furthermore, "facilities must provide a summary of the results of the mammographic examination written in lay terms to all patients within 30 days."
The lay letter need only be a summary. It must be a written summary, however; a phone call or verbal communication are not sufficient. A summary regarding abnormal results must give clear direction about the appropriate steps to be taken by the patient.
ACR recommends that you send the official interpretation to the referring provider prior to sending a lay summary report to the patient. However, BI-RADS® category 4, "Suspicious Abnormality-Biopsy Should be Considered" and category 5, "Highly Suggestive of Malignancy-Appropriate Action Should be Taken" should also be conveyed by phone to the referring physician or primary healthcare provider immediately.
The FDA Policy Guidance Help System states, "when there are 'suspicious' or 'highly suggestive of malignancy' results, the facility must also make reasonable attempts to communicate the results to the referring healthcare provider or a responsible designee as soon as possible. 'Suspicious' or 'highly suggestive of malignancy' results should be communicated to the healthcare provider within three working days, using either a written report or documented verbal communication. If this is achieved through direct communication with the healthcare provider, this does not obviate the need to also send written communication within 30 days."
The FDA further states that "when an assessment is 'suspicious' or 'highly suggestive of malignancy' the lay summary results and recommended course of action must be communicated to the patient as soon as possible. The FDA believes that communication of suspicious or highly suggestive results can be accomplished within five working days. One way to achieve this is through direct verbal communication with the patient; however, this does not eliminate the need to also send written communication within 30 days."
ACR encourages you to share samples of your lay summary reports with your referring physicians or primary healthcare providers. These steps, along with an effective communication system and policy, will foster a team approach to patient care.
The MQSA also requires the official mammography report sent to referring medical colleagues and self-referred patients to include the final mammographic assessment (BI-RADS terminology) somewhere in the report. The actual word description must appear. However, the ACR Committee on Breast Cancer recommends that both the actual word description and the BI-RADS category number appear, e.g., "Category 1 – Negative."
Things to Consider
As you develop your procedures, we recommend that you consider the following:
- You must have a written procedure that describes how your lay summary report is conveyed to the patient. We also recommend that you use a log or your RIS system to track when the written lay summary is sent.
- Give every patient a timeframe for when they should receive a lay summary report (no more than 30 days by law). Giving patients an approximate date may decrease anxiety and phone calls.
- Consider the psychosocial impact of handing the patient a written lay summary at the time of the appointment. Having a nurse or radiologist verbally review the summary with the patient can reduce anxiety.
- Discuss the importance of the correlative breast physical exam in the written lay summary. This is particularly important for self-referred patients.
- Discuss the issue with your counsel to remain compliant with local and state laws. FDA guidance and requirements on the MQSA Policy Guidance Help System page.
