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.
The 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 health care 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 health care provider or a responsible designee as soon as possible. 'Suspicious' or 'Highly suggestive of malignancy' results should be communicated to the health care provider within three working days, using either a written report or documented verbal communication. If this is achieved through direct communication with the health care 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. 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."
The ACR encourages you to share samples of your lay summary reports with your referring physicians or primary health care 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."
We recommend that you take into consideration the following issues as you develop your procedures:
- You must have a written procedure that describes how the written 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.
- Tell every patient that they should expect to receive a lay summary report within "X" days (no more than 30 days by law). Providing the patient with an approximate date of arrival may decrease anxiety and phone calls.
- If you choose to hand the patient a written lay summary at the time of the appointment, you should consider the psychosocial impact of how this is done. Having a professional such as a radiologist or a nurse verbally review the summary with the patient may reduce patient anxiety.
- The importance of the correlative breast physical exam should be discussed in the written lay summary, especially for self-referred patients.
- Finally, it is prudent to discuss this issue with your counsel so as to be in compliance also with local and state laws. FDA guidance documents regarding requirements for amended reports and other issues will appear on the FDA website on the MQSA Policy Guidance Help System page or the Communication of Results to Patients page.