Mammography Quality Standards Act Requires Direct Communication of Results to Patients
The Mammography Quality Standards Act (MQSA) requires mammography facilities across the nation to meet uniform quality standards. Congress passed this law in 1992 to assure high-quality mammography for early breast cancer detection, which can lead to early treatment, a range of treatment options, and increased chances of survival. Under the law, all mammography facilities must:
- Be accredited by an FDA-approved accreditation body
- Be certified by FDA, or its State, as meeting the standards
- Undergo an annual MQSA inspection
- Prominently display the certificate issued by the agency.
One unique provision of the MQSA is the requirement that, in addition to providing results to health care providers, mammography facilities must send each patient a written summary of the mammography report in lay terms. 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 as long as the written summary is 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.
According to the FDA, 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.
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