FDA: Direct communication of mammogram results isn’t a suggestion—it’s the law

In addition to routine follow-up phone calls, clinicians are obligated to provide women with a written summary of mammography reports once their results become available, the FDA wrote in its most recent update on the Mammography Quality Standards Act (MQSA).

Direct doctor-to-patient contact regarding mammography results isn’t just a request, the FDA wrote—it’s the law. And as technology, imaging informatics and doctors’ knowledge advances, mammogram results and follow-up requests can be communicated much more quickly than they could when Congress implemented the original act in 1992.

“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,” the statement read. “In some cases, patients who require additional imaging or workup can go from a screening mammogram to a needle biopsy in the same day.”

Information typically passes through mammography technologists and primary care providers before it reaches a patient, who can expect a call if anything seems suspicious. If something is abnormal, a tumor looks malignant or if additional imaging is necessary, the MQSA does require the medical facility to make “reasonable attempts” to deliver that news to a patient as quickly as possible.

If everything looks clean, doctors are legally obligated to send a letter—written in layperson’s terms—to the woman within 30 days of her mammogram.

“Many facilities choose to provide verbal results to patients to expedite healthcare and alleviate the anxiety of waiting for results,” the FDA said. “Just as verbal results to a healthcare 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.”

Officials wrote that the intent of this regulation is to provide a patient with a written record of her results in addition to whatever information she may have received over the phone from her primary doctor. If a patient is a non-native English speaker, the FDA also suggests providing a letter in a language the person feels comfortable with.

If multiple mammograms take place within a one-month period, the act still stipulates a concise, written report, but the FDA wrote results from the multiple imaging exams can be compiled into one document. The written results can be delivered by hand, sent electronically or snail-mailed.

“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 their own breast health and empowers their involvement in further action, whether that be continuing routine screening or engaging in recommended further evaluation,” officials wrote.

""

After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.

Trimed Popup
Trimed Popup