Radiation-Emitting Products

Direct-to-Patient Mammogram Results: It’s the Law

We live in a world of lightning-fast technology. In the radiology world, advances in teleradiology (the transmission of radiological images from one location to another for the purposes of interpretation or comparison) and the availability of workstations where physicians can review and manipulate digital images means that mammogram results and follow-up may be available to women and their healthcare providers more quickly today than in the past. In some cases, patients who require additional imaging or workup can go from a screening mammogram to a needle biopsy the same day!

Everyone involved in mammography, from the FDA to mammography facilities and their dedicated mammography technologists, interpreting physicians, and administrative staff, recognizes the importance of and shares a role in ensuring that an effective mechanism exists for communicating mammography results. While health care providers routinely receive their patients’ test results, the Mammography Quality Standards Act (MQSA) regulations have a unique provision that requires mammography facilities to send each patient a written summary of the mammography report in lay terms. While there are different approaches to achieving this goal, the regulations require that facilities maintain a system to ensure timely communication of mammography results to patients.

The content and format of the lay summary letters are left to the discretion of the facility; however, the regulations are clear about how and when patients must receive their results; the written summary must be sent within 30 days of the mammogram. If a patient’s mammogram is interpreted as “Suspicious” or “Highly Suggestive of Malignancy”, the MQSA requires the facility to make reasonable attempts to communicate those results to the patient and her referring healthcare provider as soon as possible.

For patients who are self-referred, the written mammography report, as well as the written lay summary, must be provided to the patient herself. Furthermore, the regulations also require that facilities that accept patients for mammography who do not have a health care provider must maintain a system for referring such patients to a health care provider when clinically indicated.

Many facilities choose to provide verbal results to patients to expedite health care and alleviate the anxiety of waiting for results. Just as verbal results to a health care provider must be followed up by a written medical report, any verbal communication of mammogram results to a patient must be supplemented with written communication. The intent of the regulation is that the patient herself has a written record of her results in easy to understand language, separate from the medical report delivered to her referring healthcare provider.

One common situation where verbal results might be conveyed is when a mammography exam results in an “Incomplete: Need Additional Imaging Evaluation” assessment. In addition, the facility must also provide, within 30 days of the examination, a written lay summary indicating that additional imaging is needed. If the results of the follow-up diagnostic mammographic images are available within 30 days of the screening mammogram, the facility has the option of combining the results into one lay summary letter addressing both the screening and the diagnostic work up. If one combined lay summary is provided, FDA suggests that it state specifically that it refers to both the screening and the diagnostic mammograms. If there are results from other types of follow-up imaging, for example ultrasound, available within the 30-day timeframe, these may also be included in such a combined report.

Whether it’s mailed, sent electronically, or handed to the patient, every patient that receives a mammographic exam must receive the results of that mammogram in written form. Although not required by the MQSA, facilities that have non-English reading populations may want to consider providing lay summary letters in another language to accommodate the needs of their patient population. Not only is effective communication of mammography results to women themselves a good check and balance system to ensure that results are communicated, it also gives women direct knowledge about of their own breast health and empowers their involvement in further action, whether that be continuing routine screening or engaging in recommended further evaluation.

Further information and FAQs regarding the communication of results to patients can be found in the MQSA Regulations, at 21 CFR 900.12(c)(2), and in the Policy Guidance Help System.
 

Page Last Updated: 02/15/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English